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MS212400 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background and Purpose — The effectiveness of functional electrical stimulation ( FES ) has been investigated in chronic hemiplegia . The present study examines whether FES , given during acute stroke , was more effective in promoting motor recovery of the lower extremity and walking ability than st and ard rehabilitation alone . Methods — Forty-six subjects , 70.9±8.0 years old and 9.2±4.1 days after stroke , were assigned r and omly to 1 of 3 groups receiving st and ard rehabilitation with FES or placebo stimulation or alone ( control ) . FES was applied 30 minutes and placebo stimulation 60 minutes , 5 days per week for 3 weeks . Outcome measurements included composite spasticity score , maximum isometric voluntary contraction of ankle dorsi-flexors and planter-flexors , and walking ability . They were recorded before treatment , weekly during the 3-week treatment , and at week 8 after stroke . Results — No significant differences were found in the baseline measurements . After 3 weeks of treatment , there was a significant reduction in the percentage of composite spasticity score , and a significant improvement in the ankle dorsiflexion torque , accompanied by an increase in agonist electromyogram and a reduction in electromyogram cocontraction ratio in the FES group , when compared with the other 2 groups ( P<0.05 ) . All subjects in the FES group were able to walk after treatment , and 84.6 % of them returned home , in comparison with the placebo ( 53.3 % ) and control ( 46.2 % , P<0.05 ) groups . Conclusions — Fifteen sessions of FES , applied to subjects with acute stroke plus st and ard rehabilitation , improved their motor and walking ability to the degree that more subjects were able to return to home Background and Purpose — Severe upper limb paresis is a major contributor to disability after stroke . This study investigated the efficacy of a new nonrobotic training device , the Sensorimotor Active Rehabilitation Training ( SMART ) Arm , that was used with or without electromyography-triggered electrical stimulation of triceps brachii to augment elbow extension , permitting stroke survivors with severe paresis to practice a constrained reaching task . Methods — A single-blind , r and omized clinical trial was conducted with 42 stroke survivors with severe and chronic paresis . Thirty-three participants completed the study , of whom 10 received training using the SMART Arm with electromyography-triggered electrical stimulation , 13 received training using the SMART Arm alone , and 10 received no intervention ( control ) . Training consisted of 12 1-hour sessions over 4 weeks . The primary outcome measure was “ upper arm function , ” item 6 of the Motor Assessment Scale . Secondary outcome measures included impairment measures ; triceps muscle strength , reaching force , modified Ashworth scale ; and activity measures : reaching distance and Motor Assessment Scale . Assessment s were administered before ( 0 weeks ) and after training ( 4 weeks ) and at 2 months follow-up ( 12 weeks ) . Results — Both SMART Arm groups demonstrated significant improvements in all impairment and activity measures after training and at follow-up . There was no significant difference between these 2 groups . There was no change in the control group . Conclusions — Our findings indicate that training of reaching using the SMART Arm can reduce impairment and improve activity in stroke survivors with severe and chronic upper limb paresis , highlighting the benefits of intensive task-oriented practice , even in the context of severe paresis To compare the efficacy of electromyography (EMG)-triggered ( active ) neuromuscular electrical stimulation ( NMES ) and passive NMES in enhancing the upper extremity ( UE ) motor and functional recovery of subacute and chronic stage stroke patients . Thirty-one hemiplegic patients were r and omly assigned to active NMES ( n=11 ) , passive NMES ( n=10 ) , and control ( sham stimulation ) ( n=10 ) groups . Each treatment regimen was applied five times per week for 45 min for 3 weeks . All of the patients performed the same neurophysiologic exercise program for 45 min five times per week for 3 weeks . Patients were assessed by the UE component of the Fugl-Meyer Motor Assessment ( UE-FMA ) , the self-care component of the Functional Independence Measure ( self-care FIM ) , the Motor Activity Log ( MAL ) , goniometric measurements of active wrist and metacarpophalangeal joint extension , surface EMG potentials , grip strength , and the modified Ashworth scale in a blinded manner . Data were obtained before and at the end of the treatment . Participants were similar in all clinical and demographic features ( P>0.05 ) . All groups were comparable with respect to UE-FMA , MAL , self-care FIM , wrist and finger flexor spasticity , active range of motion ( ROM ) , grip strength , and surface EMG potentials before treatment ( P>0.05 ) . The active ROM , grip strength , FMA , FIM , surface EMG potentials , and MAL : amount of use were significantly improved in the EMG-triggered NMES group compared with the controls ( P<0.05 ) . The active wrist extension ROM and FMA scores were significantly improved in the passive NMES group compared with the controls ( P<0.05 ) . There were no statistically significant differences between active and passive NMES groups in any of the parameters evaluated at the end of the treatment ( P>0.05 ) . Both active and passive NMES as adjuvant therapy in the neurophysiologic exercise program effectively enhanced the UE motor and functional recovery of stroke survivors . Vergleich der Wirksamkeit der elektromyographisch (EMG)-getriggerten ( aktiven ) neuromuskulären Elektrostimulation ( NMES ) und passiven NMES zur Verbesserung der motorischen und funktionellen Erholung der oberen Extremitäten bei Schlaganfallpatienten in der subakuten und chronischen Phase . Insgesamt 31 einseitig gelähmte Patienten wurden r and omisiert den aktiven NMES- ( n=11 ) , passiven NMES- ( n=10 ) und Kontrollgruppen ( Sham-Stimulation ) ( n=10 ) zugeordnet . Jede Therapie wurde fünfmal pro Woche jeweils 45 Minuten lang über drei Wochen hinweg angew and t. Alle Patienten unterzogen sich fünfmal pro Woche jeweils 45 Minuten lang über drei Wochen hinweg dem gleichen neurophysiologischen Übungsprogramm . Die Beurteilung der Patienten erfolgte anh and der Komponente “ obere Extremitäten ” des motorischen Funktionstests nach Fugl-Meyer ( UE-FMA ) , der Selbstversorgungskomponente des funktionalen Selbständigkeitsindexes ( Selbstversorgung FIM ) , des Motor Activity Log ( MAL ) , der goniometrischen Messung der aktiven H and gelenk- und Fingergrundgelenkextension , der Oberflächen-EMG-Potenziale , der Griffstärke und der modifizierten Ashworth-Skala in verblindeter Form . Date n wurden vor und nach Abschluss der Beh and lung erfasst . Die Teilnehmer schnitten bei allen klinischen und demographischen Merkmalen ähnlich ab ( P<0.05 ) . Alle Gruppen waren vergleichbar hinsichtlich UE-FMA , MAL , Selbstversorgungs-FIM , Spastizität der H and gelenks- und Fingerbeuger , aktiver Bewegungsamplitude ( ROM ) , Griffstärke und Oberflächen-EMG-Potenziale vor der Beh and lung ( P>0.05 ) . Aktive ROM , Griffstärke , FMA , FIM , Oberflächen-EMG-Potenziale und MAL : Das Ausmaß der Anwendung war in der EMG-getriggerten NMES-Gruppe verglichen mit den Teilnehmern der Kontrollgruppe signifikant verbessert ( P<0.05 ) . Die ROM- und FMA-Scores der aktiven H and gelenkextension waren in der passiven NMES-Gruppe verglichen mit der Kontrollgruppe signifikant verbessert ( P<0.05 ) . Es lagen keine statistisch signifikanten Unterschiede zwischen den aktiven und passiven NMES-Gruppen bei den zu Ende der Beh and lung beurteilten Parametern vor ( P>0.05 ) . Die aktive und passive NMES als Begleittherapie des neurophysiologischen Übungsprogramms verbesserte die motorische und funktionelle Genesung der oberen Extremitäten von Überlebenden eines Schlaganfalls effektiv . El objetivo de este estudio fue comparar la eficacia de la estimulación eléctrica neuromuscular ( EENM ) ( activa ) mediante electromiografía ( EMG ) y EENM pasiva con respecto a la mejora de la recuperación motora y funcional de las extremidades superiores ( ES ) en pacientes con accidente cerebrovascular subagudo y crónico . Treinta y un pacientes hemiplégicos fueron asignados de forma aleatoria al grupo de EENM activa ( n=11 ) , al grupo de EENM pasiva ( n=10 ) y al grupo control ( estímulo falso ) ( n=10 ) . Cada uno de los tratamientos se aplicó cinco veces a la semana durante 45 minutos , durante 3 semanas . Todos los pacientes fueron sometidos al mismo programa de ejercicios neurofisiológicos , con una duración de 45 minutos , cinco veces a la semana durante 3 semanas . Los pacientes fueron analizados mediante el componente de extremidades superiores de la puntuación de Fugl-Meyer ( FM-ES ) , el componente de cuidado personal de la Medida de Independencia Funcional ( MIF-CP ) , el Registro de Actividad Motora ( MAL , por sus siglas en inglés ) , las medidas goniométricas de la extensión articular activa metacarpofalángica y de la muñeca , los potenciales de EMG de superficie , la fuerza de prensión y la escala modificada de Ashworth con enmascaramiento . Se recopilaron datos previamente y posteriormente al tratamiento . Los participantes poseían características clínicas y demográficas similares ( P<0.05 ) . Todos los grupos eran comparables con respecto a FM-ES , MAL , MIF-CP , la espasticidad flexora de la muñeca y el dedo , el rango activo de movimiento ( RM ) , la fuerza de prensión y los potenciales de EMG de superficie antes de comenzar el tratamiento ( P>0.05 ) . El RM activo , la fuerza de prensión , la puntuación de FM , MIF , los potenciales de EMG de superficie y MAL mejoraron significativamente en el grupo de EENM mediante EMG en comparación con el grupo control ( P<0.05 ) . Las puntuaciones de FM y RM activo de la extensión de la muñeca mejoraron significativamente en el grupo de EENM pasiva en comparación con el grupo control ( P<0.05 ) . No se observaron diferencias estadísticamente significativas entre los grupos de EENM activa y pasiva en ninguno de los parámetros evaluados al finalizar el tratamiento ( P>0.05 ) . Tanto la EENM activa como la EENM pasiva , como tratamientos adyuvantes dentro del programa de ejercicios neurofisiológicos , mejoraron efectivamente la recuperación motora y funcional de los supervivientes de accidente cerebrovascular . Comparer l’efficacité de la stimulation électrique neuromusculaire ( NMES ) déclenchée par électromyographie ( EMG ) ( active ) et de la NMES passive dans l’amélioration de la récupération motrice et fonctionnelle des extrémités supérieures ( UE ) chez les patients victimes d’AVC en phase subaiguë et chronique . Trente et un patients hémiplégiques ont été assignés de manière aléatoire à des groupes de NMES active ( n=11 ) , passive ( n=10 ) et de contrôle ( stimulation leurre ) ( n=10 ) . Chaque traitement a été appliqué cinq fois par semaine pendant 45 min pendant 3 semaines . Tous les patients ont suivi le même programme d’exercice neurophysiologique pendant 45 min , cinq fois par semaine , pendant 3 semaines . Les patients ont été évalués en aveugle par la composante UE de l'évaluation motrice de Fugl-Meyer ( UE-FMA ) , la composante de soins auto-administrés de la mesure d’indépendance fonctionnelle ( FIM soins auto-administrés ) , le Motor Activity Log ( MAL ) , les mesures goniométriques du poignet actif et de l’extension de l’articulation métacarpophalangienne , les potentiels EMG de surface , la force de préhension et l'échelle Ashworth modifiée . Les données ont été recueillies avant et à la fin du traitement . Les participants présentaient des caractéristiques cliniques et démographiques semblables ( P<0.05 ) . Tous les groupes étaient comparables en ce qui concerne les paramètres UE-FMA , MAL , FIM soins auto-administrés , spasticité des fléchisseurs du poignet et des doigts , amplitude active des mouvements ( ROM ) , force de préhension et potentiels EMG de surface avant le traitement ( P>0.05 ) . ROM active , force de préhension , FMA , FIM , potentiels EMG de surface et MAL : volume d’utilisation significativement amélioré chez le groupe NMES déclenchée par EMG par rapport au groupe témoin ( P<0.05 ) . Les scores ROM et FMA d’extension du poignet actif ont été considérablement améliorés chez le groupe NMES passive par rapport au groupe témoin (
Output:
| NMES combined with other intervention modalities can be considered as a treatment option that provides improvements in spasticity and range of motion in patients after stroke . |
MS212401 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Although effective topical repellents provide personal protection against malaria , whether mass use of topical repellents in addition to long-lasting insecticidal nets can contribute to a further decline of malaria is not known , particularly in areas where outdoor transmission occurs . We aim ed to assess the epidemiological efficacy of a highly effective topical repellent in addition to long-lasting insecticidal nets in reducing malaria prevalence in this setting . METHODS A cluster r and omised controlled trial was done in the 117 most endemic villages in Ratanakiri province , Cambodia , to assess the efficacy of topical repellents in addition to long-lasting insecticidal nets in controlling malaria in a low-endemic setting . We did a pre-trial assessment of village accessibility and excluded four villages because of their inaccessibility during the rainy season . Another 25 villages were grouped because of their proximity to each other , result ing in 98 study clusters ( comprising either a single village or multiple neighbouring villages ) . Clusters were r and omly assigned ( 1:1 ) to either a control ( long-lasting insecticidal nets ) or intervention ( long-lasting insecticidal nets plus topical repellent ) study group after a restricted r and omisation . All clusters received one long-lasting insecticidal net per individual , whereas those in the intervention group also received safe and effective topical repellents ( picaridin KBR3023 , SC Johnson , Racine , WI , USA ) , along with instruction and promotion of its daily use . Cross-sectional surveys of 65 r and omly selected individuals per cluster were done at the beginning and end of the malaria transmission season in 2012 and 2013 . The primary outcome was Plasmodium species-specific prevalence in participants obtained by real-time PCR , assessed in the intention-to-treat population . Complete safety analysis data will be published seperately ; any ad-hoc adverse events are reported here . This trial is registered with Clinical Trials.gov , number NCT01663831 . FINDINGS Of the 98 clusters that villages were split into , 49 were assigned to the control group and 49 were assigned to the intervention group . Despite having a successful distribution system , the daily use of repellents was suboptimum . No post-intervention differences in PCR plasmodium prevalence were observed between study groups in 2012 ( 4·91 % in the control group vs 4·86 % in the intervention group ; adjusted odds ratio [ aOR ] 1·01 [ 95 % CI 0·60 - 1·70 ] ; p=0·975 ) or in 2013 ( 2·96 % in the control group vs 3·85 % in the intervention group ; aOR 1·31 [ 0·81 - 2·11 ] ; p=0·266 ) . Similar results were obtained according to Plasmodium species ( 1·33 % of participants in the intervention group vs 1·10 % in the intervention group were infected with Plasmodium falciparum ; aOR 0·83 [ 0·44 - 1·56 ] ; p=0·561 ; and 1·85 % in the control group vs 2·67 % in the intervention group were infected with Plasmodium vivax ; aOR 1·51 [ 0·88 - 2·57 ] ; p=0·133 ) . 41 adverse event notifications from nine villages were received , of which 33 were classified as adverse reactions ( 11 of these 33 were cases of repellent abuse through oral ingestion , either accidental or not ) . All participants with adverse reactions fully recovered and 17 were advised to permanently stop using the repellent . INTERPRETATION Mass distribution of highly effective topical repellents in re source -sufficient conditions did not contribute to a further decline in malaria endemicity in a pre-elimination setting in the Greater Mekong subregion . Daily compliance and appropriate use of the repellents remains the main obstacle . FUNDING Bill & Melinda Gates Foundation Background The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports , including many studies identified by their authors as r and omized controlled trials . It has been noticed that these reports mostly present positive results , and their quality and authenticity have consequently been called into question . We investigated the adequacy of r and omization of clinical trials published in recent years in China to determine how many of them met acceptable st and ards for allocating participants to treatment groups . Methods The China National Knowledge Infrastructure electronic data base was search ed for reports of r and omized controlled trials on 20 common diseases published from January 1994 to June 2005 . From this sample , a subset of trials that appeared to have used r and omization methods was selected . Twenty-one investigators trained in the relevant knowledge , communication skills and quality control issues interviewed the original authors of these trials about the participant r and omization methods and related quality -control features of their trials . Results From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure data base , we found 3137 apparent r and omized controlled trials . Of these , 1452 were studies of conventional medicine ( published in 411 journals ) and 1685 were studies of traditional Chinese medicine ( published in 352 journals ) . Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for r and omization and could on those grounds be deemed authentic r and omized controlled trials ( 6.8 % , 95 % confidence interval 5.9–7.7 ) . There was no statistically significant difference in the rate of authenticity between r and omized controlled trials of traditional interventions and those of conventional interventions . R and omized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals ( relative risk 1.58 , 95 % confidence interval 1.18–2.13 , and relative risk 14.42 , 95 % confidence interval 9.40–22.10 , respectively ) . The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals ( relative risk 9.32 , 95 % confidence interval 5.83–14.89 ) . All r and omized controlled trials of pre-market drug clinical trial were authentic by our criteria . Of the trials conducted at university-affiliated hospitals , 56.3 % were authentic ( 95 % confidence interval 32.0–81.0 ) . Conclusion Most reports of r and omized controlled trials published in some Chinese journals lacked an adequate description of r and omization . Similarly , most so called ' r and omized controlled trials ' were not real r and omized controlled trials owing toa lack of adequate underst and ing on the part of the authors of rigorous clinical trial design . All r and omized controlled trials of pre-market drug clinical trial included in this research were authentic . R and omized controlled trials conducted by authors in high level hospitals , especially in hospitals affiliated to medical universities had a higher rate of authenticity . That so many non-r and omized controlled trials were published as r and omized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed A r and omized , double-blinded , placebo-controlled study was conducted to examine the effect of spatial repellent ( SR ) in households at risk of malaria in Indonesia . Following presumptive radical cure for malaria in 180 adult men representing sentinels of new infection in four clusters within two villages , all households were given either metofluthrin or placebo mosquito coils . Weekly blood smear screening and human-l and ing mosquito catches were done throughout the 6 months intervention . Malaria infections occurred in 61 subjects living in placebo households and 31 subjects living in SR coil households , suggesting a 52 % protective effect of SR . Likewise , anopheles indoor human l and ing rates were 32 % lower in homes receiving SR coils . Differences in the malaria attack rate between SR- and placebo-treated homes was significant when not accounting for the effects of clustering . When the analysis was adjusted for intra-cluster correlation , the differences between SR- and placebo-treated homes were not statistically significant . The findings provide evidence of SR public health benefit and support a larger trial statistically powered to detect those effects Background Mosquito vectors of malaria in Southeast Asia readily feed outdoors making malaria control through indoor insecticides such as long-lasting insecticidal nets ( LLINs ) and indoor residual spraying more difficult . Topical insect repellents may be able to protect users from outdoor biting , thereby providing additional protection above the current best practice of LLINs . Methods and Findings A double blind , household r and omised , placebo-controlled trial of insect repellent to reduce malaria was carried out in southern Lao PDR to determine whether the use of repellent and long-lasting insecticidal nets ( LLINs ) could reduce malaria more than LLINs alone . A total of 1,597 households , including 7,979 participants , were recruited in June 2009 and April 2010 . Equal group allocation , stratified by village , was used to r and omise 795 households to a 15 % DEET lotion and the remainder were given a placebo lotion . Participants , field staff and data analysts were blinded to the group assignment until data analysis had been completed . All households received new LLINs . Participants were asked to apply their lotion to exposed skin every evening and sleep under the LLINs each night . Plasmodium falciparum and P. vivax cases were actively identified by monthly rapid diagnostic tests . Intention to treat analysis found no effect from the use of repellent on malaria incidence ( hazard ratio : 1.00 , 95 % CI : 0.99–1.01 , p = 0.868 ) . A higher socio-economic score was found to significantly decrease malaria risk ( hazard ratio : 0.72 , 95 % CI : 0.58–0.90 , p = 0.004 ) . Women were also found to have a reduced risk of infection ( hazard ratio : 0.59 , 95 % CI : 0.37–0.92 , p = 0.020 ) . According to protocol analysis which excluded participants using the lotions less than 90 % of the time found similar results with no effect from the use of repellent . Conclusions This r and omised controlled trial suggests that topical repellents are not a suitable intervention in addition to LLINs against malaria amongst agricultural population s in southern Lao PDR . These results are also likely to be applicable to much of the Greater Mekong Sub-region . Trial Registration This trial is registered with number We determined the efficacy of the use of permethrin-impregnated uniforms for prevention of malaria and leishmaniasis in a double-blind , r and omized study of Colombian soldiers on patrol . In the study of malaria , soldiers were issued impregnated uniforms ( i.e. , a shirt , an undershirt , pants , socks , and a hat ) or uniforms washed in water ; the soldiers wore the uniforms day and night for a mean of 4.2 weeks and were observed for an additional 4 weeks . Three ( 3 % ) of 86 soldiers wearing impregnated uniforms contracted malaria , whereas 12 ( 14 % ) of 86 soldiers wearing control uniforms contracted malaria ( P = .015 ) . In the study of leishmaniasis ( soldiers were in the area of endemicity for 6.6 weeks and were observed for 12 weeks thereafter ) , 4 ( 3 % ) of 143 soldiers wearing impregnated uniforms and 18 ( 12 % ) of 143 soldiers wearing control uniforms acquired disease ( P = .002 ) . In the leishmaniasis study , and presumably in the malaria study , breakthrough infections in the treated group were primarily due to bites in unclothed regions of the body ( face and h and s ) . Permethrin-treated uniforms were virtually nontoxic ( there were only two cases of mild skin irritation among 229 subjects ) , and impregnation is quick and inexpensive . Impregnation of clothing with permethrin is suggested for nonimmune population s who are likely to be exposed to malaria or leishmaniasis over a period of 1 - 2 months Background The study sought to determine the effect of using insecticide-treated clothes ( ITCs ) on personal protection against malaria infection . The specific objectives were to determine the effect of using ITCs on the rate of infection with malaria parasites and the effect on indoor mosquito density . Methods This study was done in Dadaab refugee camps , North Eastern Province Kenya between April and August 2002 , and involved a total of 198 participants , all refugees of Somali origin . The participants were selected through multi-stage cluster sampling . Half of the participants ( treatment group ) had their personal clothes worn on a daily basis ( Diras , Saris , Jalbaab s , Ma'awis and shirts ) and their bedding ( sheets and blankets ) treated with insecticide ( permethrin ) . The other half ( comparison group ) had their clothes treated with placebo ( plain water ) . Indoor mosquito density was determined from twelve households belonging to the participants ; six in the treatment block and six in the comparison block . During pre-test and post-test , laboratory analysis of blood sample s was done , indoor mosquito density determined and question naires administered . Using STATA statistical package , tests for significant difference between the two groups were conducted . Results Use of ITCs reduced both malaria infection rates and indoor mosquito density significantly . The odds of malaria infection in the intervention group were reduced by about 70 percent . The idea of using ITCs for malaria infection control was easily accepted among the refugees and they considered it
Output:
| Authors ' conclusions There is insufficient evidence to conclude topical or spatial repellents can prevent malaria . |
MS212402 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Developing an evidence base for making public health decisions will require using data from evaluation studies with r and omized and nonr and omized design s. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study , with sufficient detail and clarity to readily see differences and similarities among studies in the same area . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement provides guidelines for transparent reporting of r and omized clinical trials . We present the initial version of the Transparent Reporting of Evaluations with Nonr and omized Design s ( TREND ) statement . These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions , research design , and methods of adjusting for possible biases in evaluation studies that use nonr and omized design OBJECTIVE To determine whether a multicomponent health promotion intervention for Dutch adolescents ( defined as persons between 12 and 14 years of age ) would be successful in influencing body composition and dietary and physical activity behavior in both the short and long terms . DESIGN R and omized controlled trial . SETTING Ten intervention and 8 control prevocational secondary schools . PARTICIPANTS A total of 1108 adolescents ( mean age , 12.7 years ) . Intervention An interdisciplinary program with an adapted curriculum for 11 lessons in biology and physical education and environmental change options . MAIN OUTCOME MEASURES Body height and weight , waist circumference , 4 skinfold thickness measurements , and dietary and physical activity behavior data . RESULTS Multilevel analyses showed that the intervention remained effective in preventing unfavorable increases in important measures of body composition after 20-month follow-up in girls ( biceps skinfold and sum of 4 skinfolds ) and boys ( triceps , biceps , and subscapular skinfolds ) . Consumption of sugar-containing beverages was significantly lower in intervention schools both after intervention ( boys : -287 mL/d ; 95 % confidence interval [ CI ] , -527 to -47 ; girls : -249 ; -400 to -98 ) and at 12-month follow-up ( boys : -233 ; -371 to -95 ; girls : -271 ; -390 to -153 ) . For boys , screen-viewing behavior was significantly lower in the intervention group after 20 months ( -25 min/d ; 95 % CI , -50 to -0.3 ) . No significant intervention effects on consumption of snacks or active commuting to school were found . CONCLUSION The Dutch Obesity Intervention in Teenagers program result ed in beneficial effects on the sum of skinfold thickness measurements in girls and consumption of sugar-containing beverages in both boys and girls in both the short and long terms Background School-based interventions that target prevention of overweight and obesity in children have been tested with mixed results . Thus , successful interventions are still called for . The aim of the present study was to investigate effects of a multicomponent school-based intervention programme targeting physical activity , sedentary and dietary behaviours on anthropometric outcomes . Methods A 20-month intervention was evaluated in a cluster r and omised , controlled study of 1324 11-year-olds . Outcome variables were body mass index ( BMI ) , BMI -for-age z-score ( BMI z ) , waist circumference ( WC ) , waist-to-height ratio ( WTHR ) and weight status ( International Obesity Task Force 's cut-offs ) . Weight , height and WC were measured objective ly ; pubertal status was self-reported and parental education was self-reported by the parents . Intervention effects were determined by one-way analysis of covariance and logistic regression , after checking for clustering effects of school , and moderating effects of gender , pubertal status and parental education . Results Beneficial effects were found for BMI ( p=0.02 ) and BMI z ( p=0.003 ) in girls , but not in boys . While a beneficial effect was found for BMI ( p=0.03 ) in participants of parents reporting a high level of education , a negative effect was found for WTHR in participants with parents reporting a low level of education ( p=0.003 ) . There were no intervention effects for WC and weight status . Conclusions A multicomponent 20-month school-based intervention had a beneficial effect on BMI and BMI z in adolescent girls , but not in boys . Furthermore , children of higher educated parents seemed to benefit more from the intervention , and this needs attention in future interventions to avoid further increase in social inequalities in overweight and obesity Background Although school-based interventions to promote physical activity in adolescents have been suggested in several recent review s , questions have been raised regarding the effects of the strategies and the methodology applied and for whom the interventions are effective . The aim of the present study was to investigate effects of a school-based intervention program : the HEalth in Adolescents ( HEIA ) study , on change in physical activity , and furthermore , to explore whether potential effects varied by gender , weight status , initial physical activity level and parental education level . Methods This was a cluster r and omized controlled 20 month intervention study which included 700 11-year-olds . Main outcome -variable was mean count per minute ( cpm ) derived from ActiGraph accelerometers ( Model 7164/GT1 M ) . Weight and height were measured objective ly . Adolescents reported their pubertal status in a question naire and parents reported their education level on the consent form . Linear mixed models were used to test intervention effects and to account for the clustering effect of sampling by school . Results The present study showed an intervention effect on overall physical activity at the level of p = 0.05 with a net effect of 50 cpm increase from baseline to post intervention in favour of the intervention group ( 95 % CI −0.4 , 100 ) . Subgroup analyses showed that the effect appeared to be more profound among girls ( Est 65 cpm , CI 5 , 124 , p = 0.03 ) and among participants in the low-activity group ( Est 92 cpm , CI 41 , 142 , p < 0.001 ) , as compared to boys and participants in the high-activity group , respectively . Furthermore , the intervention affected physical activity among the normal weight group more positively than among the overweight , and participants with parents having 13–16 years of education more positively than participants with parents having either a lower or higher number of years of education . The intervention seemed to succeed in reducing time spent sedentary among girls but not among boys . Conclusions A comprehensive but feasible , multi-component school-based intervention can affect physical activity patterns in adolescents by increasing overall physical activity . This intervention effect seemed to be more profound in girls than boys , low-active adolescents compared to high-active adolescents , participants with normal weight compared to the overweight , and for participants with parents of middle education level as opposed to those with high and low education levels , respectively . An implementation of the HEIA intervention components in the school system may have a beneficial effect on public health by increasing overall physical activity among adolescents and possibly among girls and low-active adolescents in particular Background To improve effectiveness of future screen behaviour interventions , one needs to know whether an intervention works via the proposed mediating mechanisms and whether the intervention is equally effective among subgroups . Parental regulation is identified as a consistent correlate of screen behaviours , but prospect i ve evidence as well as the mediation role of parental regulation is largely lacking . This study investigated post-intervention main effects on screen behaviours in the HEIA-intervention – a Norwegian school-based multiple-behaviour study , as well as mediation effects of parental regulation by adolescents ’ and parents ’ report . In addition , moderating effects of gender and weight status on the intervention and mediating effects were explored . Methods Participating schools were r and omized to control ( n = 25 ) or intervention ( n = 12 ) condition . Adolescents ( n = 908 Control ; 510 Intervention ) self-reported their weekday and weekend TV-viewing and computer/game-use . Change in adolescents ’ behaviours was targeted through school and parents . Adolescents , mothers ( n = 591 Control ; 244 Interventions ) and fathers ( n = 469 Control ; 199 Intervention ) reported parental regulation of the screen behaviours post-intervention ( at 20 month ) . The product-of-coefficient test using linear regression analysis was conducted to examine main and mediating effects . Results There was no intervention effect on the screen behaviours in the total sample . Gender moderated effect on weekend computer/game-use , while weight status moderated the effect on weekday TV-viewing and computer/game-use . Stratified analyses showed a small favourable intervention effect on weekday TV-viewing among the normal weight . Parental regulation did not mediate change in the screen behaviours . However , stronger parental regulation was associated with less TV-viewing and computer/game-use with effects being conditional on adolescents ’ versus parental reports . Parental regulation of the screen behaviours , primarily by the parental report , was associated with change in the respective behaviours . Conclusion Multiple behaviour intervention may not affect all equally well , and the effect may differ by weight status and gender . In future interventions parents should be encouraged to regulate their adolescents ’ TV-viewing and computer/game-use on both weekdays and weekends as parental regulation was identified as a determinant of these screen behaviours . However , future intervention studies may need to search for more effective intervention strategies targeting parental regulation . Trial registration Current Controlled Trials IS RCT Active commuting to school increases children 's daily physical activity . The built environment is associated with children 's physical activity levels in cross-sectional studies . This study examined the role of the built environment on the outcomes of a " walking school bus " study . Geographical information systems was used to map out and compare the built environments around schools participating in a pilot walking school bus r and omised controlled trial , as well as along school routes . Multi-level modelling was used to determine the built environment attributes associated with the outcomes of active commuting to school and accelerometer-determined moderate-to-vigorous physical activity ( MPVA ) . There were no differences in the surrounding built environments of control ( n = 4 ) and intervention ( n = 4 ) schools participating in the walking school bus study . Among school walking routes , park space was inversely associated with active commuting to school ( β = -0.008 , SE = 0.004 , P = 0.03 ) , while mixed-l and use was positively associated with daily MPVA ( β = 60.0 , SE = 24.3 , P = 0.02 ) . There was effect modification such that high traffic volume and high street connectivity were associated with greater moderate-to-vigorous physical activity . The results of this study suggest that the built environment may play a role in active school commuting outcomes and daily physical activity Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field Background and purpose : The lack of effective school-based interventions for preventing obesity in children has caused a call for longer duration of interventions and better reporting on design and evaluation methodology . The purpose of this paper is to present the development of the intervention , the design of the effectiveness study , and the test-retest reliability of the main outcome measures in the HEalth In Adolescents ( HEIA ) study . Methods / design : The HEIA intervention programme was developed based on literature review s , a social ecological framework , and focus groups . The intervention aim ed to increase total physical activity ( PA ) and consumption of fruit and vegetables and to decrease screen time and consumption of sugar-sweetened beverages . The intervention programme consisted of a classroom component , including dietary behaviour lessons , computer tailoring , fruit/vegetable and PA breaks , and posters , and an environmental component including active transport campaigns , equipment , suggestions for easy improvements of schoolyards , inspirational courses for teachers ( all with regards to PA ) , and fact sheets to parents . The effect of the intervention programme is evaluated in a cluster r and omised controlled trial design ( intervention = 12 schools , control = 25 schools ) including process evaluation . Main outcomes include anthropometry , PA , screen time , and consumption of fruit , vegetables , and sugar-sweetened beverages . A 2-week test— retest study was conducted among 114 pupils . Determinants of the behaviours were assessed . Similar data were collected from parents . Children ’s PA was measured objective ly by accelerometers . Conclusions : The HEIA study represents a theoretically informed r and omised trial comprising a comprehensive set of multilevel intervention components with a thorough evaluation using reliable outcome measures . The study will contribute to a better underst and ing of determinants of healthy weight development among young people and how such determinants can be modified The annual distance walked by children has fallen 28 % since 1972 , partly because
Output:
| The analysis of the interventions using the ALBD Community Action Model showed that Preparation and Promotion were used much more frequently than Policy and Physical projects .
Conclusion Noted improvements were an increase in use of objective measures .
Lack of theory , weak method ological design and a lack of reliable and valid measurement were observed . |
MS212403 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: PURPOSE To evaluate the effectiveness and tolerability of pregabalin in the management of the discontinuation of benzodiazepines in long-term users . SUBJECTS AND METHODS We performed a 12-week , prospect i ve , uncontrolled , non-interventional , and observational study in patients aged 18 years old or above , who met DSM-IV-TR criteria for benzodiazepine dependence without other major psychiatry disorder . Evaluations included the Benzodiazepine Withdrawal Symptom Question naire , the Hamilton Anxiety Rating Scale , the Clinical Global Impression Scale , and the Sheehan Disability Scale . A urine drug screen for benzodiazepines was performed at baseline and every 4 weeks thereafter . The primary effectiveness variable was success rate , defined as achievement of benzodiazepine-free status at week 12 according to the urine drug screen . RESULTS AND DISCUSSION The mean dose at week 12 was 315 ( ±166 ) mg/day . The success rate of the benzodiazepine taper in the primary efficacy population ( n=282 ) was 52 % ( 95 % confidence interval [ CI ] , 46 - 58 ) . Success rates for women and men were 58 % ( 95 % CI , 49 - 67 ) and 46 % ( 95 % CI , 38 - 55 ) , respectively . The success rates did not differ according to either the benzodiazepine of abuse or the presence of other substance use disorders . Significant and clinical ly relevant improvements were observed in withdrawal and anxiety symptoms , as well as in patients ' functioning . At week 12 , tolerability was rated as good or excellent by 90 % and 83 % of the clinicians and patients , respectively . CONCLUSION Our results suggest that pregabalin is an efficacious and well-tolerated adjunctive treatment for benzodiazepine withdrawal Chronic normal-dose benzodiazepine users requesting drug withdrawal were allocated to substitution with either the new anxiolytic alpidem ( n = 13 ) or placebo ( n = 12 ) . During the first 2 weeks of the tapering programme , the dose of benzodiazepine was kept constant ; for the next 2 weeks it was halved and half-dose alpidem ( 25 mg twice daily ) or placebo substituted ; for weeks 5 and 6 , the benzodiazepine was discontinued and full-dose alpidem or placebo given ; next alpidem or placebo were tapered to half-dose and then finally discontinued . Regular anxiety and tranquillizer withdrawal ratings were made . Nine of 12 patients given placebo withdrew successfully compared with four of 13 alpidem-treated patients . Anxiety and other symptom levels increased in the alpidem but not the placebo patients . It was concluded that alpidem is not helpful in helping patients withdrawing from a benzodiazepine withdrawal perhaps because of partial agonist properties . These actions may imply a lesser propensity to induce dependence on long-term use Abstract Twenty-four volunteers ( 19 women and five men ) with insomnia and a history of chronic use of benzodiazepine hypnotics participated in a r and omized , double blind , controlled clinical trial . The study was design ed to assess the effects of substituting zopiclone ( ZOP ) – as an hypnotic – among chronic users of flunitrazepam ( FLU ) , and to compare the subsequent withdrawal of ZOP with placebo controlled withdrawal of FLU . During the 5 weeks of a withdrawal protocol , sleep and physiological parameters were assessed by polysomnographic measures for 11 nights and by nightly actigraphic recordings for weeks 1 , 3 , and 5 . Subjective effects of the withdrawal process were evaluated with daily sleep diaries , and with various weekly self-report symptom checklists . Paired t-tests performed on differences in objective sleep parameters between baseline and the last weeks of the withdrawal program showed a significant decrease in sleep quality within the FLU group , but not in the ZOP group . Subjective sleep diaries consistently reflected the objective ly measured changes in sleep throughout the withdrawal program , indicating significant changes in sleep parameters only in the FLU group . The results obtained from the self report inventories aim ed at assessing withdrawal symptoms , however , revealed no differences between the baseline week and the termination week of the program in any of the groups . After completing the pharmacological withdrawal , all subjects received a short-term cognitive behavioral intervention focused on improving their coping strategies with symptoms of insomnia ; they were evaluated immediately after concluding the intervention , and at 3 and 12 month follow-ups Objective To evaluate the association between use of benzodiazepines and incident dementia . Design Prospect i ve , population based study . Setting PAQUID study , France . Participants 1063 men and women ( mean age 78.2 years ) who were free of dementia and did not start taking benzodiazepines until at least the third year of follow-up . Main outcome measures Incident dementia , confirmed by a neurologist . Results During a 15 year follow-up , 253 incident cases of dementia were confirmed . New use of benzodiazepines was associated with an increased risk of dementia ( multivariable adjusted hazard ratio 1.60 , 95 % confidence interval 1.08 to 2.38 ) . Sensitivity analysis considering the existence of depressive symptoms showed a similar association ( hazard ratio 1.62 , 1.08 to 2.43 ) . A secondary analysis pooled cohorts of participants who started benzodiazepines during follow-up and evaluated the association with incident dementia . The pooled hazard ratio across the five cohorts of new benzodiazepine users was 1.46 ( 1.10 to 1.94 ) . Results of a complementary nested case-control study showed that ever use of benzodiazepines was associated with an approximately 50 % increase in the risk of dementia ( adjusted odds ratio 1.55 , 1.24 to 1.95 ) compared with never users . The results were similar in past users ( odds ratio 1.56 , 1.23 to 1.98 ) and recent users ( 1.48 , 0.83 to 2.63 ) but reached significance only for past users . Conclusions In this prospect i ve population based study , new use of benzodiazepines was associated with increased risk of dementia . The result was robust in pooled analyses across cohorts of new users of benzodiazepines throughout the study and in a complementary case-control study . Considering the extent to which benzodiazepines are prescribed and the number of potential adverse effects of this drug class in the general population , indiscriminate widespread use should be caution ed against Withdrawal from hypnotics can produce a variety of problems , especially sleep difficulties , some of which may arise from the multiple actions of most hypnotics , thus producing a range of rebound effects . This study examined whether switching patients to a hypnotic with a narrower range of action and of a different class would reduce these problems . One hundred and thirty-four patients participated ; they were r and omly allocated to one of three methods of switching from " previous hypnotic " to zopiclone ( a cyclopyrrolone ) . The methods were gap ( an interval between taking the two drugs ) ; abuttal ( taking zopiclone immediately on stopping previous drug ) ; and overlap ( gradually reducing previous drug after starting zopiclone ) . The main findings were that zopiclone was associated with better sleep and increased alertness ; the abuttal method was the best method of switching ; and no serious side effects from zopiclone were reported . It was concluded that zopiclone has a useful role in benzodiazepine withdrawal , and that immediate substitution is the best method ABSTRACT Background : Benzodiazepine use disorders are a common clinical problem among methadone maintenance treatment patients and have adverse effects on clinical outcomes . Objectives : To evaluate gabapentin for the outpatient treatment of benzodiazepine abuse or dependence in methadone maintenance patients . Methods : Participants ( n = 19 ) using benzodiazepines at least 4 days per week were enrolled into an 8-week r and omized double-blind placebo-controlled outpatient pilot trial . All participants received a manual-guided supportive psychotherapy aim ed to promote abstinence . Study medication was titrated over a 2-week period to a maximum dose of gabapentin 1200 mg or placebo three times a day . Benzodiazepine use was assessed using urine toxicology confirmed self-report . Benzodiazepines were not provided as part of study participation ; participants were provided guidance to gradually reduce benzodiazepine intake . Results : Sixteen participants had post-r and omization data for analysis . Retention at week eight was 50 % . The mean dose of gabapentin achieved by titration was 2666 mg/day ( SD = ± 1446 ) . There were no significant between group differences on benzodiazepine use outcomes ( amount benzodiazepine per day [ Mann-Whitney U = 27 , p = 0.745 ] , abstinent days per week [ U = 28 , p = 0.811 ] ) and Clinical Instrument Withdrawal Assessment (CIWA)-benzodiazepines scale ( U = 29.0 , p = 0.913 ) . One participant in the gabapentin group discontinued study medication because of peripheral edema . Two participants in the placebo group requested admission for inpatient detoxification treatment . Conclusion : In outpatient methadone-maintained patients with benzodiazepine use disorder , gabapentin did significantly decrease benzodiazepine use relative to placebo . The small sample recruited for this trial may have limited the ability to detect a group difference Ten long-term users of benzodiazepines ( average daily dose , 20 mg of diazepam or equivalent ) who had experienced problems in withdrawing from the drugs were given an i.v . challenge with either the benzodiazepine antagonist flumazenil ( 1 mg injected over 30 s ) or placebo ( vehicle solution ) in a r and omized double-blind design . There were no ' pseudo withdrawal ' responses to either single-blind or double-blind placebo injections , whereas flumazenil produced dramatic panic reactions in all four subjects tested , followed by characteristic benzodiazepine withdrawal symptoms . There were also small but significant rises in pulse rate and blood pressure , but no change in serum cortisol . Flumazenil-induced panic could not be entirely accounted for by a past or present diagnosis of panic disorder , and did not seem to be related to previous withdrawal problems , present benzodiazepine dosage , or to the severity of withdrawal symptoms precipitated by flumazenil in the same challenge test . Attempts to reduce benzodiazepine intake over the next 3 weeks tended to be more successful in the flumazenil group . The results are discussed with reference to possible changes in the GABA-benzodiazepine system in long-term benzodiazepine users Objectives . We assessed if prolonged-release melatonin can facilitate withdrawal of long-term benzodiazepine usage in patients with schizophrenia or bipolar disorder . Methods . R and omised , placebo-controlled , blinded , parallel superiority trial of 24 weeks duration . Participants were r and omised to prolonged-release melatonin 2 mg daily versus matching placebo and were continuously guided to gradually reduce their usual benzodiazepine dosage . The primary outcome was mean benzodiazepine daily dosage at 24 weeks . Secondary outcomes included pattern of benzodiazepine dosage over time , benzodiazepine cessation proportion , and benzodiazepine withdrawal symptoms . Results . In total , 86 patients ( 21–74 years ) were enrolled : 42 were r and omised to melatonin versus 44 to placebo . We found no significant effect of melatonin on mean benzodiazepine dosage at 24 weeks ( melatonin group 8.01 mg versus placebo group 5.72 mg diazepam equivalents ; difference between means –2.29 ; 95 % CI –5.78 to 1.21 ; P = 0.20 ) . Benzodiazepine cessation proportion was 38.1 % ( 16/42 ) in the melatonin group versus 47.7 % ( 21/44 ) in the placebo group ( OR 0.64 ; 95 % CI 0.26 to 1.56 ; P = 0.32 ) . Prolonged-release melatonin had no effect on benzodiazepine withdrawal symptoms . Conclusions . Benzodiazepine dosage was comparably low between the groups after 24 weeks of guided gradual dose reduction . In this context , prolonged-release melatonin did not seem to further facilitate benzodiazepine discontinuation Since recent research has suggested that the major metabolites of progesterone are barbiturate-like modulators of GABAergic function , we undertook a pilot study of the efficacy of micronized progesterone in attenuating withdrawal and facilitating discontinuation in benzodiazepine-dependent patients with a minimum of 1 year of continuous daily use . Forty-three patients taking a mean daily dose of 16.2 mg of diazepam ( or its equivalent ) were assigned , double-blind , to treatment with either placebo ( n=13 ) or progesterone ( n=30 ) . Progesterone was titrated to a mean daily dose of 1983 mg , and was co-administered for 3 weeks , after which the benzodiazepine was tapered by 25 % per week . Progesterone ( or placebo ) was then continued for 4 weeks before being discontinued . There was no progesterone versus placebo difference
Output:
| Likewise , magnesium aspartate decreased the proportion of participants discontinuing benzodiazepines ( 1 study , 144 participants ; RR 0.80 , 95 % CI 0.66 to 0.96 ; NNTH 5.8 ; very low- quality evidence ) .Generally , adverse events were insufficiently reported .
AUTHORS ' CONCLUSIONS Given the low or very low quality of the evidence for the reported outcomes , and the small number of trials identified with a limited number of participants for each comparison , it is not possible to draw firm conclusions regarding pharmacological interventions to facilitate benzodiazepine discontinuation in chronic benzodiazepine users . |
MS212404 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background The role of laparoscopic resection ( LR ) in the management of extraperitoneal rectal cancer still is unclear . This study aim ed to compare perioperative and long-term results of laparoscopic and open resection ( OR ) for low and midrectal cancer . Methods A prospect i ve nonr and omized trial comparing patients su bmi tted to OR or LR for low and midrectal cancer at a single institution was conducted . Results The study included 191 consecutive patients : 98 patients who underwent LR and 93 who underwent OR . The mean follow-up period was 46.3 months for LR and 49.7 months for OR . The conversion rate for LR was 18.4 % . With the use of LR , the mean time for complete patient mobilization was shorter ( 1.7 vs 3.3 days ; p < 0.001 ) and patients were earlier in passing flatus ( 2.6 vs 3.9 days ; p < 0.001 ) and stools ( 3.8 vs 4.7 days ; p < 0.01 ) , and in resuming oral intake ( 3.4 vs 4.8 days ; p < 0.001 ) . The mean hospital stay was shorter for LR , but the difference did not reach significance ( 11.4 vs 13 days ) . Morbidity and mortality rates were similar : LR ( 24.4 % and 1 % ) and OR ( 23.6 % and 2.2 % ) . Laparoscopic patients presented a higher rate of anastomotic fistulas ( 13.5 % vs 5.1 % ) and reoperations ( 6.1 % vs 3.2 % ) but the difference was statistically nonsignificant . Laparoscopic resection presented a significantly lower local recurrence rate ( 3.2 % vs 12.6 % ; p < 0.05 ) . The cumulative survival and disease-free rates at 5 years were , respectively , 80 % and 65.4 % after LR and 68.9 % and 58.9 % after OR ( nonsignificant difference ) . Stage-by-stage comparison showed prolonged cumulative survival for stages III and IV cancer in LR ( 82.5 % vs 40.5 % ; p = 0.006 and 15.8 % vs 0 % ; p = 0.013 , respectively ) and a reduced rate of cancer-related death for stage III in LR ( 11.4 % vs 51.9 % ; p = 0.001 ) . Conclusions As compared with conventional open surgery , LR for low and midrectal cancer is characterized by a faster recovery and similar overall morbidity ( but a higher rate of anastomotic leakages ) , and does not present any adverse oncologic effect BACKGROUND Laparoscopic surgery as an alternative to open surgery in patients with rectal cancer has not yet been shown to be oncologically safe . The aim in the COlorectal cancer Laparoscopic or Open Resection ( COLOR II ) trial was to compare laparoscopic and open surgery in patients with rectal cancer . METHODS A non-inferiority phase 3 trial was undertaken at 30 centres and hospitals in eight countries . Patients ( aged ≥18 years ) with rectal cancer within 15 cm from the anal verge without evidence of distant metastases were r and omly assigned to either laparoscopic or open surgery in a 2:1 ratio , stratified by centre , location of tumour , and preoperative radiotherapy . The study was not masked . Secondary ( short-term ) outcomes -including operative findings , complications , mortality , and results at pathological examination-are reported here . Analysis was by modified intention to treat , excluding those patients with post-r and omisation exclusion criteria and for whom data were not available . This study is registered with Clinical Trials.gov , number NCT00297791 . FINDINGS The study was undertaken between Jan 20 , 2004 , and May 4 , 2010 . 1103 patients were r and omly assigned to the laparoscopic ( n=739 ) and open surgery groups ( n=364 ) , and 1044 were eligible for analyses ( 699 and 345 , respectively ) . Patients in the laparoscopic surgery group lost less blood than did those in the open surgery group ( median 200 mL [ IQR 100 - 400 ] vs 400 mL [ 200 - 700 ] , p<0·0001 ) ; however , laparoscopic procedures took longer ( 240 min [ 184 - 300 ] vs 188 min [ 150 - 240 ] ; p<0·0001 ) . In the laparoscopic surgery group , bowel function returned sooner ( 2·0 days [ 1·0 - 3·0 ] vs 3·0 days [ 2·0 - 4·0 ] ; p<0·0001 ) and hospital stay was shorter ( 8·0 days [ 6·0 - 13·0 ] vs 9·0 days [ 7·0 - 14·0 ] ; p=0·036 ) . Macroscopically , completeness of the resection was not different between groups ( 589 [ 88 % ] of 666 vs 303 [ 92 % ] of 331 ; p=0·250 ) . Positive circumferential resection margin ( < 2 mm ) was noted in 56 ( 10 % ) of 588 patients in the laparoscopic surgery group and 30 ( 10 % ) of 300 in the open surgery group ( p=0·850 ) . Median tumour distance to distal resection margin did not differ significantly between the groups ( 3·0 cm [ IQR 2·0 - 4·8 ] vs 3·0 cm [ 1·8 - 5·0 ] , respectively ; p=0·676 ) . In the laparoscopic and open surgery groups , morbidity ( 278 [ 40 % ] of 697 vs 128 [ 37 % ] of 345 , respectively ; p=0·424 ) and mortality ( eight [ 1 % ] of 699 vs six [ 2 % ] of 345 , respectively ; p=0·409 ) within 28 days after surgery were similar . INTERPRETATION In selected patients with rectal cancer treated by skilled surgeons , laparoscopic surgery result ed in similar safety , resection margins , and completeness of resection to that of open surgery , and recovery was improved after laparoscopic surgery . Results for the primary endpoint-locoregional recurrence-are expected by the end of 2013 . FUNDING Ethicon Endo-Surgery Europe , Swedish Cancer Foundation , West Gothia Region , Sahlgrenska University Hospital Purpose Laparoscopic surgery of colon cancer has been accepted to be oncologically adequate compared with open resection . However , the situation in rectal cancer remains unclear , because anatomy and complex surgical procedures might specifically influence the long-term outcome . This study was design ed to analyze perioperative and long-term outcome of patients with rectal cancer after laparoscopic vs. open access surgery . Methods A total of 389 patients ( 1998–2005 ) were prospect ively analyzed ; 114 patients had laparoscopic beginning , and 25 patients had conversion and were separately analyzed . Eighty-nine patients remained in the laparoscopic group and 275 had open access surgery . Results Both groups were comparable regarding age , gender , tumor localization , stage , and complications . Differences were found in harvested lymph nodes ( laparoscopic 13.5/open access 16.9 ; P = 0.001 ) and hospitalization ( 15.1/18.7 days ; P = 0.037 ) . Local recurrence rate and metachronous metastasis were comparable . In patients with deep anterior resection with total mesenteric excision , favorable long-term survival in the laparoscopic group was found ( P = 0.035 , log-rank ) . Conclusions Minimally invasive surgery is equivalent in the treatment of rectal cancer and shows advantages of shorter hospitalization and faster recovery . Especially in patients with low rectal cancer , minimally invasive surgery with exact preparation of the total mesenteric excision seems to be favorable compared with open access surgery BACKGROUND Minimally invasive , laparoscopically assisted surgery was first considered in 1990 for patients undergoing colectomy for cancer . Concern that this approach would compromise survival by failing to achieve a proper oncologic resection or adequate staging or by altering patterns of recurrence ( based on frequent reports of tumor recurrences within surgical wounds ) prompted a controlled trial evaluation . METHODS We conducted a noninferiority trial at 48 institutions and r and omly assigned 872 patients with adenocarcinoma of the colon to undergo open or laparoscopically assisted colectomy performed by credentialed surgeons . The median follow-up was 4.4 years . The primary end point was the time to tumor recurrence . RESULTS At three years , the rates of recurrence were similar in the two groups--16 percent among patients in the group that underwent laparoscopically assisted surgery and 18 percent among patients in the open-colectomy group ( two-sided P=0.32 ; hazard ratio for recurrence , 0.86 ; 95 percent confidence interval , 0.63 to 1.17 ) . Recurrence rates in surgical wounds were less than 1 percent in both groups ( P=0.50 ) . The overall survival rate at three years was also very similar in the two groups ( 86 percent in the laparoscopic-surgery group and 85 percent in the open-colectomy group ; P=0.51 ; hazard ratio for death in the laparoscopic-surgery group , 0.91 ; 95 percent confidence interval , 0.68 to 1.21 ) , with no significant difference between groups in the time to recurrence or overall survival for patients with any stage of cancer . Perioperative recovery was faster in the laparoscopic-surgery group than in the open-colectomy group , as reflected by a shorter median hospital stay ( five days vs. six days , P<0.001 ) and briefer use of parenteral narcotics ( three days vs. four days , P<0.001 ) and oral analgesics ( one day vs. two days , P=0.02 ) . The rates of intraoperative complications , 30-day postoperative mortality , complications at discharge and 60 days , hospital readmission , and reoperation were very similar between groups . CONCLUSIONS In this multi-institutional study , the rates of recurrent cancer were similar after laparoscopically assisted colectomy and open colectomy , suggesting that the laparoscopic approach is an acceptable alternative to open surgery for colon cancer Purpose This study was design ed to evaluate the impact of laparoscopic rectal resection on short-term postoperative morbidity and costs . Methods A total of 168 patients with rectal cancer were r and omly assigned to laparoscopic ( n = 83 ) or open ( n = 85 ) resection . Outcome parameters were : postoperative morbidity , length of hospital stay , quality of life , long-term survival , and local recurrences . The mean follow-up period was 53.6 months . Cost-benefit analysis was based on hospital costs . Results Operative time was 53 minutes longer in the laparoscopic group ( P < 0.0001 ) . Postoperative morbidity rate was 28.9 percent in the laparoscopic vs. 40 percent in the open group ( P = 0.18 ) . The mean length of hospital stay was 10 ( 4.9 ) days in the laparoscopic group and 13.6 ( 10 ) days in the open group ( P = 0.004 ) . Local recurrence rate and five-year survival were similar in both groups ; however , the limited number of patients does not allow firm conclusions . Quality of life was better in the laparoscopic group only in the first year after surgery ( P < 0.0001 ) . The additional charge in the laparoscopic group was $ 1,748 per patient r and omized ( $ 1,194 the result of surgical instruments and $ 554 the result of longer operative time ) . The saving in the laparoscopic group was $ 1,396 per patient r and omized ( $ 647 the result of shorter length of hospital stay and $ 749 the result of the lower cost of postoperative complications ) . The net balance result ed in $ 351 extra cost per patient r and omly allocated to the laparoscopic group . Conclusions Short-term postoperative morbidity was similar in the two groups . Laparoscopic resection reduced length of hospital stay , improved first-year quality of life , and slightly increased hospital costs BACKGROUND The safety and short-term benefits of laparoscopic colectomy for cancer remain debatable . The multicentre COLOR ( COlon cancer Laparoscopic or Open Resection ) trial was done to assess the safety and benefit of laparoscopic resection compared with open resection for curative treatment of patients with cancer of the right or left colon . METHODS 627 patients were r and omly assigned to laparoscopic surgery and 621 patients to open surgery . The primary endpoint was cancer-free survival 3 years after surgery . Secondary outcomes were short-term morbidity and mortality , number of positive resection margins , local recurrence , port-site or wound-site recurrence , metastasis , overall survival , and blood loss during surgery . Analysis was by intention to treat . Here , clinical
Output:
| Subgroup analysis of patients with extraperitoneal cancer showed equivalent involvement of the circumferential margin in the two treatment groups .
The sensitivity and subgroup analyses revealed no other significant differences between laparoscopic and open surgery in the rate of R0 resections , distal margin clearance , mesorectal fascia integrity , or local recurrence at 5 years .
Conclusions Based on the evidence from RCTs and non- RCTs , the short-term benefit and oncological adequacy of laparoscopic rectal resection appear to be equivalent to open surgery , with some evidence potentially pointing to comparable long-term outcomes and oncological adequacy in selected patients with primary resectable rectal cancer |
MS212405 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: OBJECTIVES To assess the morbidity and efficacy of bipolar radiofrequency thermal ablation tonsillectomy and compare it with traditional cold dissection tonsillectomy with diathermy hemostasis . DESIGN Prospect i ve , r and omized , single-blinded , controlled clinical study . SETTING Helsinki University Central Hospital , Department of Otorhinolaryngology-Head & Neck Surgery , Helsinki , Finl and . PATIENTS Forty healthy volunteer patients aged 18 to 65 years admitted for elective tonsillectomy with recurrent or chronic tonsillitis , obstructive tonsillar hypertrophy , or history of quinsy . Two patients were excluded from the study and 1 patient cancelled the operation . INTERVENTIONS Nineteen patients underwent a traditional cold dissection tonsillectomy with diathermy hemostasis , and 18 patients underwent a bipolar radiofrequency thermal ablation tonsillectomy . There was no intergroup difference in age , sex , weight , and indications for tonsillectomy . The subjects were not informed of the type of procedure until the telephone interview 3 weeks after the operation . MAIN OUTCOME MEASURES Operating time and intraoperative blood loss ; need for anesthetics during the operation ; different recovery indicators in the recovery room ( ie , duration and medications administered ) , surgical ward ( ie , medications administered , use of corticosteroids , general condition , and status of the uvula on the first postoperative day ) , and in the 2 weeks following surgery ( ie , visual analog scale scores on 6 symptoms , medications needed , the day patients returned to work , use of antibiotics , and retreatment acceptance ) ; and complications and certain laboratory parameters . RESULTS There was a statistically significant but clinical ly insignificant difference in operating time and intraoperative blood loss in favor of the traditional tonsillectomy group . The other outcome measures showed no statistically significant differences . CONCLUSION Bipolar radiofrequency thermal ablation and traditional tonsillectomy were associated with similar postoperative morbidity OBJECTIVE Tonsillectomy has been described using a number of techniques . Recently Coblation Technology has been used to remove tonsils with anecdotal evidence of a reduction in post-operative morbidity . In this study we aim to see if there is any difference in post-operative pain , tonsillar fossae healing and return to a normal diet performing tonsillectomy , using tissue coblation compared with st and ard bipolar dissection . METHODS A double blind r and omised control trial to compare the technique of tissue coblation with st and ard bipolar dissection to remove tonsils in 38 children on the waiting list for tonsillectomy , with a history of chronic tonsillitis or obstructive tonsils . RESULTS A significant reduction in post-operative pain was found in the children whose tonsils were removed by tissue coblation ( P<0.0001 ) . More rapid healing of the tonsillar fossae was found in the coblation group . Children who had their tonsils removed by coblation were found to return to their normal diet far sooner than those who underwent bipolar dissection . There were no episodes of primary or secondary haemorrhage in either group . CONCLUSIONS This new technique using tissue coblation for tonsil removal offers significant advantages in the post-operative period , with rapid return to a normal diet and a drastic reduction in analgesic requirements following the surgery Objectives Coblation is operated in low temperature , so it is proposed that tonsillectomy with coblation involves less postoperative pain and allows accelerated healing of the tonsillar fossae compared with other methods involving heat driven processes . However , the results of the previous studies showed that the effect of coblation tonsillectomy has been equivocal in terms of postoperative pain and hemorrhage . Though , most of the previous studies which evaluated coblation tonsillectomy were performed in children . Recently , electrocautery tonsillectomy has been used most widely because of the reduced intraoperative blood loss and shorter operative time compared to other techniques . This prospect i ve study compared intraoperative records and postoperative clinical outcomes in adolescents and adults following coblation and electrocautery tonsillectomies . Methods Eighty patients over 16 years of age with histories of recurrent tonsillitis were enrolled . The patients were r and omly allocated into coblation ( n=40 ) and electrocautery tonsillectomy groups ( n=40 ) . All operations were performed by one surgeon who was skilled in both surgical techniques . Intraoperative parameters and postoperative outcomes were checked . Results Postoperative pain and otalgia were not significantly different between the two groups ; however , there was a tendency towards reduced pain and otalgia in the coblation group . More cotton balls for swabbing the operative field were used introoperatively in the electrocautery group ( P=0.00 ) . There was no significant difference in postoperative hemorrhage , wound healing , commencement of a regular diet , and foreign body sensation between the groups . Conclusion Only cotton use , which represented the amount of blood loss , was less in the coblation tonsillectomy group . Coblation tonsillectomy warrants further study with respect to the decreased postoperative pain and otalgia Coblation tonsillectomy has shown promising results with respect to postoperative pain when compared with other techniques . Our study was design ed to compare this technique with bipolar scissor tonsillectomy . Forty adult patients with a history of chronic or recurrent tonsillitis referred for st and ard tonsillectomy were recruited and r and omized into two groups . Twenty were operated with Coblator and 20 with bipolar scissors . Exclusion criteria were a history of quinsy , bleeding disorder , or any major health problems . All participants completed the study . Postoperative pain , return to normal diet , and estimated need for sick leave were utilized as parameters . Data on operative time , difficulty of tissue removal , and hemostasis were also analyzed . Operative time was longer ( P < 0.001 ) and tissue removal as well as hemostasis control were more difficult ( P = 0.005 , P = 0.013 ) with Coblator than with bipolar scissors . Participants in Coblator group assessed higher pain scores 1 and 3 h postoperatively ( P = 0.044 , P = 0.036 ) . From the time of extubation , patients had access to an opioid ( fentanyl ) via a self-controlled analgesia device . The number of doses of analgesics needed during the hospital stay was significantly higher in the Coblator group ( P = 0.020 ) . During the 14-day follow-up , no significant differences were found in pain scores , return to solid food or subjective working ability between the groups . Considering the overall outcome of the patients the results did not favor coblation technique over bipolar scissors The aim of this prospect i ve r and omized single blind study was to determine the depth of thermal damage to tonsillar tissue due to coblation , and to compare it with thermal damage to tonsillar tissue following conventional tonsillectomy ; to correlate the depth of thermal damage to tonsillar tissue with the parameters of postoperative morbidity , to compare intraoperative blood loss , postoperative pain severity , time to resuming normal physical activity , and incidence of postoperative bleeding between two groups of tonsillectomized children aged up to 16 years . 72 children aged 3 - 16 years scheduled for tonsillectomy r and omly assigned into two groups su bmi tted either to conventional tonsillectomy with bipolar diathermy coagulation or to coblation tonsillectomy , with a 14-day follow up . Statistically significant differences were observed in the depth of thermal damage to tonsillar tissue ( p < 0.001 ) , intraoperative blood loss ( p < 0.004 ) , in postoperative pain severity ( p < 0.05 ) and in time to resuming normal physical activity between the two groups ( p < 0.001 ) . There was no case of reactionary or secondary bleeding in either group . In this paper for the first time we have correlated postoperative morbidity and thermal tissue damage : less thermal damage is associated with less postoperative morbidity OBJECTIVE To compare plasma-mediated ablation ( PMA ) with monopolar electrosurgery ( MES ) for pediatric tonsillectomy . DESIGN Prospect i ve , r and omized , blinded study . SETTING Academic children 's hospital . PARTICIPANTS Thirty-four children , aged 4 to 7 years . INTERVENTIONS Tonsillectomy by means of PMA ( n = 17 ) or MES ( n = 17 ) . OUTCOME MEASURES We measured surgical efficacy , estimated blood loss , and surgical time during tonsillectomy and morphine use , immediate postoperative pain , and recovery scores after tonsillectomy . Parents recorded recovery of normal diet and activity and their own return to work for 10 days after surgery . Histopathologic evaluation of excised tonsils was performed . We review ed medical records and attempted follow-up telephone contact . RESULTS With no significant difference in blood loss compared with MES , PMA was effective for tonsillectomy . Performance of PMA took longer ( 24 vs 16 minutes ; P = .002 ) . Results of histopathologic evaluation showed less thermal injury with PMA than with MES ( P = .03 ) . Morphine consumption , pain , and recovery scores were equivalent between groups . We found no significant difference in recovery of normal diet and activity or parental return to work . Patients undergoing PMA had a greater number of perioperative complications than those undergoing MES , including 2 patients in the PMA group ( compared with none in the MES group ) who required unplanned admission for postoperative airway obstruction . CONCLUSIONS Plasma-mediated ablation for pediatric tonsillectomy result ed in less histopathologic thermal injury than MES , but did not show a statistically faster recovery to normal activity and diet or parental return to work . In addition , PMA took longer to perform , and had more complications . Therefore , PMA should not replace MES for pediatric tonsillectomy . The reduced thermal injury with PMA supports investigation into other means of using plasma ablation to treat tonsillar hypertrophy OBJECTIVE To conduct an adequately powered , prospect i ve , r and omised , controlled trial comparing adult dissection tonsillectomy using either ultrasonic scalpel , bipolar electrocautery , bipolar radiofrequency or ' cold steel ' dissection . METHODS Three hundred patients were r and omised into four tonsillectomy technique groups . The operative time , intra-operative bleeding , post-operative pain , tonsillar fossa healing , return to full diet , return to work and post-operative complications were recorded . RESULTS The bipolar radiofrequency group had a shorter mean operative time . The mean intra-operative blood loss during bipolar radiofrequency tonsillectomy was significantly less compared with cold dissection and ultrasonic scalpel tonsillectomy . Pain scores were significantly higher after bipolar electrocautery tonsillectomy . Patients undergoing bipolar electrocautery tonsillectomy required significantly more days to return to full diet and work . The bipolar electrocautery group showed significantly reduced tonsillar fossa healing during the first and second post-operative weeks . CONCLUSION In this adult series , bipolar radiofrequency tonsillectomy was superior to ultrasonic , bipolar electrocautery and cold dissection tonsillectomies . This method combines the advantages of ' hot ' and ' cold ' tonsillectomy Objectives : The aim of this study was to compare postoperative symptoms following coblation tonsillectomy with those experienced following a traditional cold dissection Objective Comparison of coblation and monopolar electrocautery tonsillectomy in terms of postoperative pain and recovery . Study Design Prospect i ve double-blind r and omized controlled trial . Methods Patients with recurrent tonsillitis requiring tonsillectomy were r and omized to 2 groups : coblation or monopolar electrocautery tonsillectomy . Postoperative pain , complications , and days taken to return to work and normal diet were compared and analyzed with the aid of a pain diary , given to the patient . Results 67 patients were recruited . Patients undergoing coblation tonsillectomy were able to return to normal diet in a shorter space of time following surgery . Patients undergoing coblation tonsillectomy were more likely to recommend the surgery than patients undergoing electrocautery tonsillectomy . No significant differences in the daily visual analog score for pain were seen for both groups of patients . Conclusions Our results showed that coblation tonsillectomy has a faster recovery period and may offer advantages when compared to monopolar electrocautery tonsillectomy OBJECTIVES To compare the advantages and disadvantages of potassium titanyl phosphate laser with those of bipolar radiofrequency techniques , in paediatric tonsillectomy . STUDY DESIGN Prospect i ve , r and omised , clinical study . PATIENTS AND METHODS From July 2004 to April 2006 , 80 patients aged between 10 and 15 years , with tonsillectomy planned for chronic tonsillitis , were included in the study . Children were prospect ively r and omised into two equal groups : potassium titanyl phosphate laser tonsillectomy and bipolar radiofrequency tonsillectomy . Operative time and intra-operative blood loss were recorded . Patients were scheduled for follow up during the first , second and fourth post-operative weeks . They were asked to record their pain and discomfort on a st and ardised visual analogue scale , from zero ( no pain ) to 10 ( severe pain ) . Post-operative complications were also recorded and managed . RESULTS The potassium titanyl phosphate laser group showed a slightly longer operative time ( mean 12 minutes ) than the bipolar radiofrequency group ( mean 10 minutes ) . Intra-operative blood loss was significantly less in the potassium titanyl phosphate laser group ( mean 21 cm3 ) than in the bipolar radiofrequency group ( mean 30 cm3 )
Output:
| More recent studies appeared to fare more favourably in terms of pain outcomes and operating time .
The coblation technique appears to be comparable with other commonly employed techniques for tonsillectomy ; however , there is still no strong evidence to suggest that it possesses any definitive benefits . |
MS212406 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Smoking exerts detrimental effects on dental treatment and oral health . Our goal was to evaluate effectiveness in terms of the abstinence rate in smoking-cessation intervention delivered by dental professionals . Individuals who were willing to quit smoking were r and omly assigned to either an intervention or a non-intervention group . Intensive intervention was provided , consisting of 5 counseling sessions , including an additional nicotine replacement regimen . Reported abstinence was verified by the salivary cotinine level . Thirty-three persons in the intervention and 23 in the non-intervention group started the trial . On an intent-to-treat basis , 3- , 6- and 12-month continuous abstinence rates in the intervention group were 51.5 % , 39.4 % , and 36.4 % , respectively , while the rates in the non-intervention group were consistent at 13.0 % . Adjusted odds ratios ( 95 % confidence interval ) by logistic stepwise regression analyses were 7.1 ( 1.8 , 28.5 ) , 8.9 ( 1.7 , 47.2 ) , and 6.4 ( 1.3 , 30.7 ) , respectively . Intensive smoking-cessation intervention in the dental setting was therefore effective Background Tobacco use continues to be a global public health problem . Helping patients to quit is part of the preventive role of all health professionals . There is now increasing interest in the role that the dental team can play in helping their patients to quit smoking . The aim of this study was to determine the feasibility of undertaking a r and omised controlled smoking cessation intervention , utilising dental hygienists to deliver tobacco cessation advice to a cohort of periodontal patients . Methods One hundred and eighteen patients who attended consultant clinics in an outpatient dental hospital department ( Periodontology ) were recruited into a trial . Data were available for 116 participants , 59 intervention and 57 control , and were analysed on an intention-to-treat basis . The intervention group received smoking cessation advice based on the 5As ( ask , advise , assess , assist , arrange follow-up ) and were offered nicotine replacement therapy ( NRT ) , whereas the control group received ' usual care ' . Outcome measures included self-reported smoking cessation , verified by salivary cotinine measurement and CO measurements . Self-reported measures in those trial participants who did not quit included number and length of quit attempts and reduction in smoking . Results At 3 months , 9/59 ( 15 % ) of the intervention group had quit compared to 5/57 ( 9 % ) of the controls . At 6 months , 6/59 ( 10 % ) of the intervention group quit compared to 3/57 ( 5 % ) of the controls . At one year , there were 4/59 ( 7 % ) intervention quitters , compared to 2/59 ( 4 % ) control quitters . In participants who described themselves as smokers , at 3 and 6 months , a statistically higher percentage of intervention participants reported that they had had a quit attempt of at least one week in the preceding 3 months ( 37 % and 47 % , for the intervention group respectively , compared with 18 % and 16 % for the control group ) . Conclusion This study has shown the potential that trained dental hygienists could have in delivering smoking cessation advice . While success may be modest , public health gain would indicate that the dental team should participate in this activity . However , to add to the knowledge-base , a multi-centred r and omised controlled trial , utilising biochemical verification would be required to be undertaken Background The dental visit is a unique opportunity for tobacco control . Despite evidence of effectiveness in dental setting s , brief provider-delivered cessation advice is underutilized . Objective To evaluate an Internet-delivered intervention design ed to increase implementation of brief provider advice for tobacco cessation in dental practice setting s. Methods Dental practice s ( N = 190 ) were r and omized to the intervention website or wait-list control . Pre-intervention and after 8 months of follow-up , each practice distributed exit cards ( brief patient surveys assessing provider performance , completed immediately after the dental visit ) to 100 patients . Based on these exit cards , we assessed : whether patients were asked about tobacco use ( ASK ) and , among tobacco users , whether they were advised to quit tobacco ( ADVISE ) . All intervention practice s with follow-up exit card data were analyzed as r and omized regardless of whether they participated in the Internet-delivered intervention . Results Of the 190 practice s r and omized , 143 ( 75 % ) dental practice s provided follow-up data . Intervention practice s ’ mean performance improved post-intervention by 4 % on ASK ( 29 % baseline , adjusted odds ratio = 1.29 [ 95 % CI 1.17 - 1.42 ] ) , and by 11 % on ADVISE ( 44 % baseline , OR = 1.55 [ 95 % CI 1.28 - 1.87 ] ) . Control practice s improved by 3 % on ASK ( Adj . OR 1.18 [ 95 % CI 1.07 - 1.29 ] ) and did not significantly improve in ADVISE . A significant group-by-time interaction effect indicated that intervention practice s improved more over the study period than control practice s for ADVISE ( P = 0.042 ) but not for ASK . Conclusion This low-intensity , easily disseminated intervention was successful in improving provider performance on advice to quit . Trial Registration clinical trials.gov NCT00627185 ; http:// clinical trials.gov/ct2/show/NCT00627185 ( Archived by WebCite at http://www.webcitation.org/5c5Kugvzj BACKGROUND Community dental clinics are good setting s for smoking intervention . The aim here was to put forward a strategy for preventing adolescent smoking by means of a brief intervention . METHODS A total of 2,586 12-year-olds participated in this follow-up study . They were asked upon arrival for their annual routine dental examination to complete a smoking question naire and were r and omly assigned to either the intervention group or the usual care control group according to the last digit of their date of birth ( odd or even ) . The intervention comprised annually inquiring about smoking , showing photographs of the harmful effects of smoking on the teeth , allowing participants to examine their own mouth with a mirror , and finally counselling them in accordance with their answer to the question on smoking habits . The smoking status reported was not verified by other means . RESULTS The prevalence of smoking at the end of the 2-year follow-up was 18.1 % , in the intervention group and 20.8 % among the controls . However , no statistically significant differences between groups were found . CONCLUSIONS These results reflect the difficulties of achieving successful results with long-term smoking cessation programs with adolescents in unstable conditions To examine the effectiveness of advising patients who use tobacco to quit , the authors conducted a r and omized clinical trial to test a brief office-based intervention with all tobacco users in 75 fee-for-service dental practice s in Oregon . The authors found that the dental hygienist-delivered intervention was effective in getting smokeless tobacco users to quit at three and 12 months and to sustain abstinence at both three and 12 months . They found that the program was not effective for cigarette smokers . The authors discuss the public health implication s of program dissemination and widespread program adoption Ninety-eight cigarette smokers attending the Newcastle upon Tyne Dental Hospital , wishing to reduce their tobacco consumption , received smoking reduction advice in combination with dental health instruction and periodontal care . Those advised against smoking showed a greater reduction ( P < 0.001 ) in reported cigarette consumption during treatment and follow-up , compared with 38 control subjects who received dental health instruction but no advice against smoking . Fifty percent of intervention subjects reported reducing to half or less than half of their initial cigarette consumption , compared with 24 % for controls . Eighty percent of those advised against smoking reported some reduction , against 29 % for controls . The reported smoking cessation rate in the intervention group was 13.3 % , compared with 5.3 % in the control subjects . The results indicate that advice against smoking combined with dental health instruction and periodontal care can be an effective aid to reducing tobacco We describe a r and omized trial design ed to evaluate the effectiveness of a smokeless tobacco cessation intervention delivered by dental hygienists as part of a patient 's regularly scheduled cleaning visit . Seventy-five practice s were r and omized to continue their usual care ( n=25 ; 239 smokeless tobacco using patients enrolled ) or to receive training to provide a tobacco cessation intervention ( n=50 ; 394 smokeless tobacco using patients enrolled ) . Patient reports indicated that the training program was successful in getting hygienists to implement the intervention . The intervention produced a strong effect on sustained quitting for smokeless tobacco users but had no impact on secondary outcomes , including unsuccessful quit attempts , future intent to quit using smokeless tobacco , and change in readiness to quit using . Frequency of smokeless tobacco use and receipt of specific components of the intervention , including the video and written material s , predicted sustained cessation . Since this intervention was delivered by dental hygienists as part of a patient 's regularly scheduled cleaning visit , it is easily disseminable Cigarette smoking is a major risk factor for head and neck cancer , and individuals who continue to smoke past diagnosis and treatment are at elevated risk for further disease . In a r and omized controlled trial , a state of the art provider-delivered smoking cessation intervention was compared to a usual care advice control condition . The intervention consisted of surgeon- or dentist-delivered advice to stop smoking , a contracted quit date , tailored written material s , and booster advice sessions . Subjects were 186 patients with newly diagnosed first primary squamous cell carcinomas of the upper aerodigestive tract who had smoked cigarettes within the past year . At r and omization , 88.2 % of subjects were current smokers . At 12-month follow-up , 70.2 % of subjects completing the trial ( n = 114 ) were continuous abstainers ; among baseline smokers alone the continuous abstinence ( CA ) rate was 64.6 % . The cotinine validation rate at 12 months was 89.6 % . Modeling techniques were utilized in order to derive expected CA rates , which included noncompleter subjects ( n = 72 ) . The CA rate expected at 1 year for the entire patient population was 64.2 % , and for smokers alone the expected CA rate was 59.4 % . Logistic regression analysis carried out on baseline smokers identified predictors of 12-month CA status . These included medical treatment , stage of change , age , nicotine dependence , and race . The intervention effect was not significant , although the sign of the effect was positive . Based on these findings , we recommend systematic brief advice to stop smoking for head and neck cancer patients , with a stepped care approach for patients less able to quit Biochemical validation of smoking status has long been considered essential , but recent reports have question ed its utility in certain kinds of field trials . We describe efforts to biochemically vali date self-reports of smoking cessation from participants in four large-scale r and omized trials in outpatient clinics , hospitals , worksites , and dental clinics . These studies included over 5,000 adults smokers who participated in the population -based low-intensity intervention evaluations . At a 1-year follow-up , 798 subjects reported no tobacco use . We attempted to verify these reports using saliva continine/carbon monoxide validation procedures . Overall , there was a moderately high nonparticipation rate ( 27 % ) , a low disconfirmation rate ( 4 % ) , and a high self-reported relapse rate ( 12 % ) in the interval between survey and biochemical validation . There were no differences between intervention and control conditions on any of the above variables . Longer duration s of self-reported abstinence were strongly related to increased probability of biochemical confirmation . Differences in results across projects were related to how biochemical validation was conducted . These results , as well as statistical power considerations , raise questions about whether biochemical validation procedures are practical , informative , or cost-effective in such population -based , low-intensity intervention research A sample of private orthodontic practice s ( n = 40 ) from a controlled trial for clinician-initiated tobacco-use prevention was used to test the effectiveness of preventive medicine representative ( PMR ) visits in creating and maintaining an anti-tobacco office environment . Clinical staff of 20 offices , r and omly assigned to the experimental group , were trained by a PMR on the use of anti-tobacco material s ( no-smoking signs , posters , and print material s ) . Twenty control-group offices did not receive any training or special treatment . Subsequently , experimental-group offices were visited by a PMR once every three months and were telephoned six weeks after each visit over a 12-month period . During visits and phone calls , PMRs prompted offices to order anti-tobacco material s. Visits served to introduce offices to new material s and to encourage their continued use . Data from direct observations and self-report measures showed significant differences between experimental and control offices for display of anti-tobacco material s at 1.5 months and 12 months ( P < .001 ) . Results suggest that PMR visits may serve as an effective method of introducing and maintaining preventive medicine procedures in clinical environments SMILES PLUS was the first study to extend the clinician-delivered logic model to prevention of tobacco use among adolescents . This multi-site trial with 154 participating offices , based on social learning theory and a behavioral ecological model , was design ed
Output:
| Available evidence suggests that behavioral interventions for tobacco cessation conducted by oral health professionals incorporating an oral examination component in the dental office or community setting may increase tobacco abstinence rates among both cigarette smokers and smokeless tobacco users .
Differences between the studies limit the ability to make conclusive recommendations regarding the intervention components that should be incorporated into clinical practice , however , behavioral counselling ( typically brief ) in conjunction with an oral examination was a consistent intervention component that was also provided in some control groups |
MS212407 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Background — Recent evidence suggests that visit-to-visit variability in systolic blood pressure ( SBP ) and maximum SBP are predictors of cardiovascular disease . However , it remains uncertain whether these parameters predict the risks of macrovascular and microvascular complications in patients with type 2 diabetes mellitus . Methods and Results — The Action in Diabetes and Vascular Disease : Preterax and Diamicron Modified Release Controlled Evaluation ( ADVANCE ) was a factorial r and omized controlled trial of blood pressure lowering and blood glucose control in patients with type 2 diabetes mellitus . The present analysis included 8811 patients without major macrovascular and microvascular events or death during the first 24 months after r and omization . SBP variability ( defined as st and ard deviation ) and maximum SBP were determined during the first 24 months after r and omization . During a median 2.4 years of follow-up from the 24-month visit , 407 major macrovascular ( myocardial infa rct ion , stroke , or cardiovascular death ) and 476 microvascular ( new or worsening nephropathy or retinopathy ) events were observed . The association of major macrovascular and microvascular events with SBP variability was continuous even after adjustment for mean SBP and other confounding factors ( both P<0.05 for trend ) . Hazard ratios ( 95 % confidence intervals ) for the highest tenth of SBP variability were 1.54 ( 0.99–2.39 ) for macrovascular events and 1.84 ( 1.19–2.84 ) for microvascular events in comparison with the lowest tenth . For maximum SBP , hazard ratios ( 95 % confidence intervals ) for the highest tenth were 3.64 ( 1.73–7.66 ) and 2.18 ( 1.04–4.58 ) , respectively . Conclusion — Visit-to-visit variability in SBP and maximum SBP were independent risk factors for macrovascular and microvascular complications in type 2 diabetes mellitus . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique Identifier : NCT00145925 To assess the prognostic significance of blood pressure ( BP ) variability , we followed health outcomes in a family-based r and om population sample representative of the general population ( n=2944 ; mean age : 44.9 years ; 50.7 % women ) . At baseline , BP was measured 5 times consecutively at each of 2 home visits 2 to 4 weeks apart . We assessed within-subject overall ( 10 readings ) , within- and between-visit systolic BP variability from variability independent of the mean , the difference between maximum and minimum BP , and average real variability . Over a median follow-up of 12 years , 401 deaths occurred and 311 participants experienced a fatal or nonfatal cardiovascular event . Overall systolic BP variability averaged ( SD ) 5.45 ( 2.82 ) units , 15.87 ( 8.36 ) mmHg , and 4.08 ( 2.05 ) mmHg for variability independent of the mean , difference between maximum and minimum BP , and average real variability , respectively . Female sex , older age , higher-mean systolic BP , lower body mass index , a history of peripheral arterial disease , and use of & bgr;-blockers were the main correlates of systolic BP variability . In multivariable-adjusted analyses , overall and within- and between-visit BP variability did not predict total or cardiovascular mortality or the composite of any fatal plus nonfatal cardiovascular end point . For instance , the hazard ratios for all cardiovascular events combined in relation to overall variability independent of the mean , difference between maximum and minimum BP , and average real variability were 1.05 ( 0.96–1.15 ) , 1.06 ( 0.96–1.16 ) , and 1.08 ( 0.98–1.19 ) , respectively . By contrast , mean systolic BP was a significant predictor of all end points under study , independent of BP variability . In conclusion , in an unbiased population sample , BP variability did not contribute to risk stratification over and beyond mean systolic BP Variability in blood pressure predicts cardiovascular disease in young- and middle-aged subjects , but relevant data for older individuals are sparse . We analysed data from the PROspect i ve Study of Pravastatin in the Elderly at Risk ( PROSPER ) study of 5804 participants aged 70–82 years with a history of , or risk factors for cardiovascular disease . Visit-to-visit variability in blood pressure ( st and ard deviation ) was determined using a minimum of five measurements over 1 year ; an inception cohort of 4819 subjects had subsequent in-trial 3 years follow-up ; longer-term follow-up ( mean 7.1 years ) was available for 1808 subjects . Higher systolic blood pressure variability independently predicted long-term follow-up vascular and total mortality ( hazard ratio per 5 mmHg increase in st and ard deviation of systolic blood pressure = 1.2 , 95 % confidence interval 1.1–1.4 ; hazard ratio 1.1 , 95 % confidence interval 1.1–1.2 , respectively ) . Variability in diastolic blood pressure associated with increased risk for coronary events ( hazard ratio 1.5 , 95 % confidence interval 1.2–1.8 for each 5 mmHg increase ) , heart failure hospitalisation ( hazard ratio 1.4 , 95 % confidence interval 1.1–1.8 ) and vascular ( hazard ratio 1.4 , 95 % confidence interval 1.1–1.7 ) and total mortality ( hazard ratio 1.3 , 95 % confidence interval 1.1–1.5 ) , all in long-term follow-up . Pulse pressure variability was associated with increased stroke risk ( hazard ratio 1.2 , 95 % confidence interval 1.0–1.4 for each 5 mmHg increase ) , vascular mortality ( hazard ratio 1.2 , 95 % confidence interval 1.0–1.3 ) and total mortality ( hazard ratio 1.1 , 95 % confidence interval 1.0–1.2 ) , all in long-term follow-up . All associations were independent of respective mean blood pressure levels , age , gender , in-trial treatment group ( pravastatin or placebo ) and prior vascular disease and cardiovascular disease risk factors . Our observations suggest variability in diastolic blood pressure is more strongly associated with vascular or total mortality than is systolic pressure variability in older high-risk subjects Visit-to-visit blood pressure variability ( VTV-BPV ) is an independent risk factor for cardiovascular events and death in the general population . We sought to determine the association of VTV-BPV with outcomes in patients on hemodialysis , using data from a National Institutes of Health-sponsored r and omized trial ( the HEMO study ) . We used the coefficient of variation ( CV ) and the average real variability in systolic blood pressure ( SBP ) as metrics of VTV-BPV . In all , 1844 out of 1846 r and omized subjects had at least three visits with SBP measurements and were included in the analysis . Median follow-up was 2.5 years ( interquartile range 1.3–4.3 years ) , during which time there were 869 deaths from any cause and 408 ( adjudicated ) cardiovascular deaths . The mean pre-dialysis SBP CV was 9.9±4.6 % . In unadjusted models , we found a 31 % higher risk of death from any cause per 10 % increase in VTV-BPV . This association was attenuated after multivariable adjustment but remained statistically significant . Similarly , we found a 28 % higher risk of cardiovascular death per 10 % increase in VTV-BPV , which was attenuated and no longer statistically significant in fully adjusted models . The associations among VTV-BPV , death and cardiovascular death were modified by baseline SBP . In a diverse , well-dialyzed cohort of patients on maintenance hemodialysis , VTV-BPV , assessed using metrics of variability in pre-dialysis SBP , was associated with a higher risk of all-cause mortality and a trend toward higher risk of cardiovascular mortality , particularly in patients with a lower baseline SBP Objective To investigate whether baseline systolic blood pressure variability was a risk factor for stroke , cardiovascular mortality or cardiac events during the Syst-Eur trial . Design The Syst-Eur study was a r and omized , double-blind , placebo-controlled trial , powered to detect differences in stroke rate between participants on active antihypertensive treatment and placebo . Systolic blood pressure variability measurements were made on 744 participants at the start of the trial . Systolic blood pressure variability was calculated over three time frames : 24 h , daytime and night-time . The placebo and active treatment subgroups were analysed separately using an intention-to-treat principle , adjusting for confounding factors using a multiple Cox regression model . Participants An elderly hypertensive European population . Main outcome measures Stroke , cardiac events ( fatal and non-fatal heart failure , fatal and non-fatal myocardial infa rct ion and sudden death ) and cardiovascular mortality ( death attributed to stroke , heart failure , myocardial infa rct ion , sudden death , pulmonary embolus , peripheral vascular disease and aortic dissection ) . Results The risk of stroke increased by 80 % ( 95 % confidence interval : 17–176 % ) for every 5 mmHg increase in night-time systolic blood pressure variability in the placebo group . Risk of cardiovascular mortality and cardiac events was not significantly altered . Daytime variability readings did not predict outcome . Antihypertensive treatment did not affect systolic blood pressure variability over the median 4.4-year follow-up . Conclusion In the placebo group , but not the active treatment group , increased night-time systolic blood pressure variability on admission to the Syst-Eur trial was an independent risk factor for stroke during the trial Objective : To assess how visit-to-visit variability of SBP correlates with systemic atherosclerotic change and various prognoses . Background : Visit-to-visit SBP variability correlates with cardiovascular events . However , the mechanisms underlying the impact of visit-to-visit SBP variability on prognoses are poorly understood . Methods and results : A total of 485 patients with essential hypertension from the Non-Invasive Atherosclerotic Evaluation in Hypertension ( NOAH ) study cohort were included . We analyzed the correlation between visit-to-visit SBP variability and multiple clinical parameters . Next , we prospect ively examined the correlation of SBP variability and frequency of cardiovascular disease ( CVD ) and total mortality . Patients with higher SBP variability exhibited significantly higher rates of statin use , as well as higher pulse wave velocity ( PWV ) , left-ventricular mass index ( LVMI ) , plaque score , and resistive index of the common carotid artery ; these patients also exhibited lower estimated glomerular filtration rate . Kaplan – Meier analysis demonstrated that patients with higher SBP variability have a significantly higher incidence of CVD and mortality rate . The hazard ratio of SBP variability for incidence of CVD was greatly diminished after adjustment for intima – media thickness , plaque score , and resistive index , and was slightly diminished after adjustment for PWV and LVMI . Visit-to-visit SBP variability remained an independent risk factor for mortality after adjustment . Conclusion : Visit-to-visit SBP variability correlates significantly with systemic atherosclerotic change , incidence of CVD , and mortality rate . Altered arterial functions , such as macrovascular atherosclerosis and vascular resistance , are responsible for the correlations between visit-to-visit SBP variability and incidence of CVD Introduction : Fluorescence in situ hybridization ( FISH ) is currently the st and ard for diagnosing anaplastic lymphoma kinase (ALK)-rearranged ( ALK+ ) lung cancers for ALK inhibitor therapies . ALK immunohistochemistry ( IHC ) may serve as a screening and alternative diagnostic method . The Canadian ALK ( CALK ) study was initiated to implement a multicenter optimization and st and ardization of laboratory developed ALK IHC and FISH tests across 14 hospitals . Methods : Twenty-eight lung adenocarcinomas with known ALK status were used as blinded study sample s. Thirteen laboratories performed IHC using locally developed staining protocol s for 5A4 , ALK1 , or D5F3 antibodies ; results were assessed by H-score . Twelve centers conducted FISH using protocol s based on Vysis ’ ALK break-apart FISH kit . Initial IHC results were used to optimize local IHC protocol s , followed by a repeat IHC study to assess the results of st and ardization . Three laboratories conducted a prospect i ve parallel IHC and FISH analysis on 411 consecutive clinical sample s using post-validation optimized assays . Results : Among study sample s , FISH demonstrated 22 consensus ALK+ and six ALK wild type tumors . Preoptimization IHC scores from 12 centers with 5A4 and the percent abnormal cells by FISH from 12 centers showed intraclass correlation coefficients of 0.83 and 0.68 , respectively . IHC optimization improved the intraclass correlation coefficients to 0.9
Output:
| Conclusion : In summary , among the wide heterogenetic population , modest associations between VVV of SBP and all-cause mortality , CVD incidence , CVD mortality , CHD incidence , and stroke incidence were found . |
MS212408 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Out of 253 patients fulfilling criteria for a first episode of schizophrenic illness , 120 entered a r and omised placebo-controlled trial of maintenance neuroleptic medication on discharge ; they were followed to relapse or loss to follow-up , for two years or to the end of the study . Of those on active medication , 46 % relapsed , as did 62 % of those on placebo ; the most important determinant of relapse was duration of illness prior to starting neuroleptic medication . This finding might be because extended duration of symptoms before admission is more likely to be present in illnesses which in any case will have poor prognosis , or because susceptibility to relapse is reduced by early institution of treatment . The study provides no data on which a decision between these alternative explanations can be based Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more CONTEXT Progressive brain volume changes in schizophrenia are thought to be due principally to the disease . However , recent animal studies indicate that antipsychotics , the mainstay of treatment for schizophrenia patients , may also contribute to brain tissue volume decrement . Because antipsychotics are prescribed for long periods for schizophrenia patients and have increasingly widespread use in other psychiatric disorders , it is imperative to determine their long-term effects on the human brain . OBJECTIVE To evaluate relative contributions of 4 potential predictors ( illness duration , antipsychotic treatment , illness severity , and substance abuse ) of brain volume change . DESIGN Predictors of brain volume changes were assessed prospect ively based on multiple informants . SETTING Data from the Iowa Longitudinal Study . PATIENTS Two hundred eleven patients with schizophrenia who underwent repeated neuroimaging beginning soon after illness onset , yielding a total of 674 high-resolution magnetic resonance scans . On average , each patient had 3 scans ( ≥2 and as many as 5 ) over 7.2 years ( up to 14 years ) . MAIN OUTCOME MEASURE Brain volumes . RESULTS During longitudinal follow-up , antipsychotic treatment reflected national prescribing practice s in 1991 through 2009 . Longer follow-up correlated with smaller brain tissue volumes and larger cerebrospinal fluid volumes . Greater intensity of antipsychotic treatment was associated with indicators of generalized and specific brain tissue reduction after controlling for effects of the other 3 predictors . More antipsychotic treatment was associated with smaller gray matter volumes . Progressive decrement in white matter volume was most evident among patients who received more antipsychotic treatment . Illness severity had relatively modest correlations with tissue volume reduction , and alcohol/illicit drug misuse had no significant associations when effects of the other variables were adjusted . CONCLUSIONS Viewed together with data from animal studies , our study suggests that antipsychotics have a subtle but measurable influence on brain tissue loss over time , suggesting the importance of careful risk-benefit review of dosage and duration of treatment as well as their off-label use OBJECTIVE To compare the consequences of a guided discontinuation strategy and maintenance treatment in remitted first-episode psychosis in terms of relapse rates and functional outcome . METHOD The study was conducted in 7 mental health care organizations and the Department of Psychiatry of the University Medical Center Groningen in The Netherl and s , covering a catchment area of 3.1 million inhabitants . A sample of 131 remitted first-episode patients , aged 18 to 45 years , with a DSM-IV diagnosis of schizophrenia or related psychotic disorder was included ( i.e. , all patients with a first psychotic episode from October 2001 through December 2002 who were willing to participate ) . After 6 months of positive symptom remission , they were r and omly and openly assigned to the discontinuation strategy or maintenance treatment . Maintenance treatment was carried out according to American Psychiatric Association guidelines , preferably using low-dose atypical antipsychotics . The discontinuation strategy was carried out by gradual symptom-guided tapering of dosage and discontinuation if feasible . Follow-up was 18 months . Main outcome measures were relapse rates and social and vocational functioning . RESULTS Twice as many relapses occurred with the discontinuation strategy ( 43 % vs. 21 % , p = .011 ) . Of patients who received the strategy , approximately 20 % were successfully discontinued . Recurrent symptoms caused another approximately 30 % to restart antipsychotic treatment , while in the remaining patients discontinuation was not feasible at all . There were no advantages of the discontinuation strategy regarding functional outcome . CONCLUSIONS Only a limited number of patients can be successfully discontinued . High relapse rates do not allow a discontinuation strategy to be universal practice . However , if relapse risk can be carefully managed by close monitoring , in some remitted first-episode patients a guided discontinuation strategy may offer a feasible alternative to maintenance treatment . Further research is needed to find predictors of successful discontinuation In a simple remitted , nonpsychotic schizophrenics , the relapse rate within one year was significantly higher for those patients taking placebo as opposed to those taking fluphenazine hydrochloride orally or fluphenazine decanoate . There were no differences in relapse rates between the two active drugs , but there were significantly more terminations due to toxicity from fluphenazine decanoate than from pluphenazine given orally , entirely due to the fact that in 35 % of patients receiving fluphenazine decanoate , severe akinesia developed IMPORTANCE Short-term outcome studies of antipsychotic dose-reduction/discontinuation strategies in patients with remitted first-episode psychosis ( FEP ) showed higher relapse rates but no other disadvantages compared with maintenance treatment ; however , long-term effects on recovery have not been studied before . OBJECTIVE To compare rates of recovery in patients with remitted FEP after 7 years of follow-up of a dose reduction/discontinuation ( DR ) vs maintenance treatment ( MT ) trial . DESIGN Seven-year follow-up of a 2-year open r and omized clinical trial comparing MT and DR . SETTING One hundred twenty-eight patients participating in the original trial were recruited from 257 patients with FEP referred from October 2001 to December 2002 to 7 mental health care services in a 3.2 million- population catchment area . Of these , 111 patients refused to participate and 18 patients did not experience remission . PARTICIPANTS After 7 years , 103 patients ( 80.5 % ) of 128 patients who were included in the original trial were located and consented to follow-up assessment . INTERVENTION After 6 months of remission , patients were r and omly assigned to DR strategy or MT for 18 months . After the trial , treatment was at the discretion of the clinician . MAIN OUTCOMES AND MEASURES Primary outcome was rate of recovery , defined as meeting the criteria of symptomatic and functional remission . Determinants of recovery were examined using logistic regression analysis ; the treatment strategy ( MT or DR ) was controlled for baseline parameters . RESULTS The DR patients experienced twice the recovery rate of the MT patients ( 40.4 % vs 17.6 % ) . Logistic regression showed an odds ratio of 3.49 ( P = .01 ) . Better DR recovery rates were related to higher functional remission rates in the DR group but were not related to symptomatic remission rates . CONCLUSIONS AND RELEVANCE Dose reduction/discontinuation of antipsychotics during the early stages of remitted FEP shows superior long-term recovery rates compared with the rates achieved with MT . To our knowledge , this is the first study showing long-term gains of an early-course DR strategy in patients with remitted FEP . Additional studies are necessary before these results are incorporated into general practice . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N16228411 Abstract Objective . To assess the effect of withdrawal of antipsychotic treatment on relapse risk in remitted first-episode schizophrenia patients . Methods . First-episode 1-year stable and remitted out patients with a schizophrenic disorder were r and omly allocated to continuation of their antipsychotic regimen for at least 6 months ( N = 9 ) , or gradual withdrawal ( N = 11 ) . Primary outcome was the difference in cumulative relapse-free survival at 9 months . Results . Recruitment was terminated prematurely on 26 October 2005 . The cumulative relapse-free survival was 88 % ( SE = 0.12 ) in the continuation and 18 % ( SE = 0.12 ) in the discontinuation group ( P = 0.001 ) at 9 months follow-up . Conclusions . Discontinuation of antipsychotic medication markedly increases the risk of relapse in stable remitted first-episode schizophrenia patients . In future studies the topics of safety monitoring and sampling of patients should receive extra attention OBJECTIVE To describe the longer-term clinical and functional outcome of a large , epidemiologic representative cohort of individuals experiencing a first episode of psychosis . METHOD A naturalistic , prospect i ve follow-up of an epidemiologic sample of 723 consecutive first-episode psychosis patients , followed between January 1998 and April 2005 , at a median of 7.4 years after initial presentation to the Early Psychosis Prevention and Intervention Centre ( EPPIC ) in Melbourne , Australia . EPPIC is a frontline public mental health early psychosis program , servicing a geographically defined catchment area with a population of about 800,000 people . The main outcome measures included the Brief Psychiatric Rating Scale , the Schedule for the Assessment of Negative Symptoms , the Beck Depression Inventory , the Global Assessment of Functioning Scale , the Social and Occupational Functioning Assessment Scale , the Quality of Life Scale , and the remission criteria developed by the Remission in Schizophrenia Working Group . RESULTS Follow-up information was collected on up to 90.0 % ( n = 651 ) of the baseline cohort of 723 participants , with 66.9 % ( n = 484 ) interviewed . In the last 2 years , 57 % of individuals with schizophrenia/schizophreniform , 54 % with schizoaffective disorder , 62 % with affective psychosis , and 68 % with other psychotic disorders reported some paid employment . Depending upon the criteria applied , symptomatic remission at follow-up was observed in 37%-59 % of the cohort . Social/vocational recovery was observed in 31 % of the cohort . Approximately a quarter achieved both symptomatic remission and social/vocational recovery . CONCLUSION The relatively positive outcomes are consistent with a beneficial effect of specialized early intervention programs ; however it is premature to draw firm conclusions . There was no control group and there are many differences between the relevant comparison studies and the present one . Although difficult to conduct , large scale controlled health services research trials are required to definitively determine the impact and optimal duration of specialized early psychosis programs OBJECTIVE The goal of this report was to examine the clinical course following neuroleptic discontinuation of patients with recent-onset schizophrenia who had been receiving maintenance antipsychotic treatment for at least 1 year . METHOD Fifty-three volunteer patients with recent-onset schizophrenia who had been clinical ly stabilized on a maintenance regimen of fluphenazine decanoate for a mean of 16.7 months had their antipsychotic medications withdrawn under clinical supervision . Participants initially entered a 24-week , double-blind crossover trial in which fluphenazine and placebo were administered for 12 weeks each . For those who did not experience symptom exacerbation or relapse during this period , fluphenazine was openly withdrawn ; participants were then followed for up to 18 additional months . RESULTS When a low threshold for defining symptom reemergence was used , 78 % ( N=39 of 50 ) of the patients experienced an exacerbation or relapse within 1 year ; 96 % ( N=48 of 50 ) did so within 2 years . Mean time to exacerbation or relapse was 235 days . When hospitalization was used as a relapse criterion , only six of 45 of individuals ( 13 % ) experiencing an exacerbation or relapse who continued in treatment in the clinic were hospitalized , demonstrating the sensitivity of the psychotic exacerbation criterion . CONCLUSIONS The vast majority of clinical ly stable individuals with recent-onset schizophrenia will experience an exacerbation or relapse after antipsychotic discontinuation , even after more than a year of maintenance medication . However , clinical monitoring and a low threshold for reinstating medications can prevent hospitalization for the majority of these patients AIMS Discontinuation of antipsychotics following remission in first episode psychosis ( FEP ) is a contentious area of practice . We aim ed to investigate the views of early psychosis clinicians on this important clinical question . METHODS We design ed an 11 question online survey on medication discontinuation following remission of symptoms in FEP . The question naire was distributed to early intervention team workers in Engl and and Wales via members of the National Early Psychosis Network who were requested to distribute it to their teams . RESULTS We received 172 question naire responses ; 37 % were nurses , 33 % doctors , 11 % psychologists and 19 % were other allied health professionals . The average years of experience in psychiatry was 16.9 . 75.4 % of respondents thought that greater than 60 % of patients would like to be considered for guided medication reduction/discontinuation . Only 31.4 % of respondents said that medication should be continued for over a year following remission . 61.4 % of respondents felt that the quality of life of individuals was better in those who stop medication following remission . There was a significant difference in the response of professional
Output:
| Conclusions There is a higher risk of relapse for those who undergo total or targeted discontinuation strategies compared with maintenance antipsychotics in FEP sample s. The effect size is moderate and the risk difference is lower in trials of targeted discontinuation strategies . |
MS212409 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Mitoxantrone plus prednisone reduces pain and improves the quality of life in men with advanced , hormone-refractory prostate cancer , but it does not improve survival . We compared such treatment with docetaxel plus prednisone in men with this disease . METHODS From March 2000 through June 2002 , 1006 men with metastatic hormone-refractory prostate cancer received 5 mg of prednisone twice daily and were r and omly assigned to receive 12 mg of mitoxantrone per square meter of body-surface area every three weeks , 75 mg of docetaxel per square meter every three weeks , or 30 mg of docetaxel per square meter weekly for five of every six weeks . The primary end point was overall survival . Secondary end points were pain , prostate-specific antigen ( PSA ) levels , and the quality of life . All statistical comparisons were against mitoxantrone . RESULTS As compared with the men in the mitoxantrone group , men in the group given docetaxel every three weeks had a hazard ratio for death of 0.76 ( 95 percent confidence interval , 0.62 to 0.94 ; P=0.009 by the stratified log-rank test ) and those given weekly docetaxel had a hazard ratio for death of 0.91 ( 95 percent confidence interval , 0.75 to 1.11 ; P=0.36 ) . The median survival was 16.5 months in the mitoxantrone group , 18.9 months in the group given docetaxel every 3 weeks , and 17.4 months in the group given weekly docetaxel . Among these three groups , 32 percent , 45 percent , and 48 percent of men , respectively , had at least a 50 percent decrease in the serum PSA level ( P<0.001 for both comparisons with mitoxantrone ) ; 22 percent , 35 percent ( P=0.01 ) , and 31 percent ( P=0.08 ) had predefined reductions in pain ; and 13 percent , 22 percent ( P=0.009 ) , and 23 percent ( P=0.005 ) had improvements in the quality of life . Adverse events were also more common in the groups that received docetaxel . CONCLUSIONS When given with prednisone , treatment with docetaxel every three weeks led to superior survival and improved rates of response in terms of pain , serum PSA level , and quality of life , as compared with mitoxantrone plus prednisone A multicenter phase I clinical trial of RP 56976 ( docetaxel ) , a new anticancer drug , was performed with single and repeated doses . Based on the results of phase I clinical trials conducted in the United States and Europe , the starting dose was 10 mg/m2 . The dose was subsequently increased to 20 , 50 , 70 and 90 mg/m2 . A dose of 60 mg/m2 was additionally tested . Single administrations of the six dose levels were performed in a total of 27 patients via intravenous drip infusion over one hour . Ten of the patients subsequently received repeated doses at three of the dose levels in the same manner . The dose limiting factor ( DLF ) of docetaxel is leukopenia ( especially , neutropenia ) . Based on the observation of the DLF , the maximum tolerated dose ( MTD ) was determined to be 70 - 90 mg/m2 . The white blood cell count reached a nadir about 9.5 - 19.5 days ( median ) after administration , and took 7 - 11 days ( median ) to recover . Other adverse reactions observed were nausea/vomiting anorexia , alopecia , diarrhea , fatigue and fever , which were all acceptable . The results of this trial suggest that a dosage regimen of 60 mg/m2 at 3- to 4 week intervals is appropriate in an early phase II clinical trial BACKGROUND Docetaxel administered every 3 weeks is a st and ard treatment for castration-resistant advanced prostate cancer . We hypothesised that 2-weekly administration of docetaxel would be better tolerated than 3-weekly docetaxel in patients with castration-resistant advanced prostate cancer , and did a prospect i ve , multicentre , r and omised , phase 3 study to compare efficacy and safety . METHODS Eligible patients had advanced prostate cancer ( metastasis , a prostate-specific-antigen test result of more than 10·0 ng/mL , and WHO performance status score of 0 - 2 ) , had received no chemotherapy ( except with estramustine ) , had undergone surgical or chemical castration , and had been referred to a treatment centre in Finl and , Irel and , or Sweden . Enrolment and treatment were done between March 1 , 2004 , and May 31 , 2009 . R and omisation was done central ly and stratified by centre and WHO performance status score of 0 - 1 vs 2 . Patients were assigned 75 mg/m(2 ) docetaxel intravenously on day 1 of a 3-week cycle , or 50 mg/m(2 ) docetaxel intravenously on days 1 and 15 of a 4-week cycle . 10 mg oral prednisolone was administered daily to all patients . The primary endpoint was time to treatment failure ( TTTF ) . We assessed data in the per- protocol population . This study is registered with Clinical Trials.gov , number NCT00255606 . FINDINGS 177 patients were r and omly assigned to the 2-weekly docetaxel group and 184 to the 3-weekly group . 170 patients in the 2-weekly group and 176 in the 3-weekly group were included in the analysis . The 2-weekly administration was associated with significantly longer TTTF than was 3-weekly administration ( 5·6 months , 95 % CI 5·0 - 6·2 vs 4·9 months , 4·5 - 5·4 ; hazard ratio 1·3 , 95 % CI 1·1 - 1·6 , p=0·014 ) . Grade 3 - 4 adverse events occurred more frequently in the 3-weekly than in the 2-weekly administration group , including neutropenia ( 93 [ 53 % ] vs 61 [ 36 % ] ) , leucopenia ( 51 [ 29 % ] vs 22 [ 13 % ] ) , and febrile neutropenia ( 25 [ 14 % ] vs six [ 4 % ] ) . Neutropenic infections were reported more frequently in patients who received docetaxel every 3 weeks ( 43 [ 24 % ] vs 11 [ 6 % ] , p=0·002 ) . INTERPRETATION Administration of docetaxel every 2 weeks seems to be well tolerated in patients with castration-resistant advanced prostate cancer and could be a useful option when 3-weekly single-dose administration is unlikely to be tolerated . FUNDING Sanofi Background Abiraterone acetate plus prednisolone improves survival in men with relapsed prostate cancer . We assessed the effect of this combination in men starting long‐term and rogen‐deprivation therapy ( ADT ) , using a multigroup , multistage trial design . Methods We r and omly assigned patients in a 1:1 ratio to receive ADT alone or ADT plus abiraterone acetate ( 1000 mg daily ) and prednisolone ( 5 mg daily ) ( combination therapy ) . Local radiotherapy was m and ated for patients with node‐negative , nonmetastatic disease and encouraged for those with positive nodes . For patients with nonmetastatic disease with no radiotherapy planned and for patients with metastatic disease , treatment continued until radiologic , clinical , or prostate‐specific antigen ( PSA ) progression ; otherwise , treatment was to continue for 2 years or until any type of progression , whichever came first . The primary outcome measure was overall survival . The intermediate primary outcome was failure‐free survival ( treatment failure was defined as radiologic , clinical , or PSA progression or death from prostate cancer ) . Results A total of 1917 patients underwent r and omization from November 2011 through January 2014 . The median age was 67 years , and the median PSA level was 53 ng per milliliter . A total of 52 % of the patients had metastatic disease , 20 % had node‐positive or node‐indeterminate nonmetastatic disease , and 28 % had node‐negative , nonmetastatic disease ; 95 % had newly diagnosed disease . The median follow‐up was 40 months . There were 184 deaths in the combination group as compared with 262 in the ADT‐alone group ( hazard ratio , 0.63 ; 95 % confidence interval [ CI ] , 0.52 to 0.76 ; P<0.001 ) ; the hazard ratio was 0.75 in patients with nonmetastatic disease and 0.61 in those with metastatic disease . There were 248 treatment‐failure events in the combination group as compared with 535 in the ADT‐alone group ( hazard ratio , 0.29 ; 95 % CI , 0.25 to 0.34 ; P<0.001 ) ; the hazard ratio was 0.21 in patients with nonmetastatic disease and 0.31 in those with metastatic disease . Grade 3 to 5 adverse events occurred in 47 % of the patients in the combination group ( with nine grade 5 events ) and in 33 % of the patients in the ADT‐alone group ( with three grade 5 events ) . Conclusions Among men with locally advanced or metastatic prostate cancer , ADT plus abiraterone and prednisolone was associated with significantly higher rates of overall and failure‐free survival than ADT alone . ( Funded by Cancer Research U.K. and others ; STAMPEDE Clinical Trials.gov number , NCT00268476 , and Current Controlled Trials number , IS RCT N78818544 . Recent insights into the regulation of the and rogen receptor ( AR ) activity led to novel therapeutic targeting of AR function in prostate cancer patients . Docetaxel is an approved chemotherapy for treatment of castration-resistant prostate cancer ; however , the mechanism underlying the action of this tubulin-targeting drug is not fully understood . This study investigates the contribution of microtubules and the cytoskeleton to and rogen-mediated signaling and the consequences of their inhibition on AR activity in human prostate cancer . Tissue microarrays from docetaxel-treated and untreated prostate cancer patients were comparatively analyzed for prostate-specific antigen ( PSA ) and AR immunoreactivity . The AR transcriptional activity was determined in prostate cancer cells in vitro , based on PSA mRNA expression and the and rogen response element reporter activity . The interaction of AR with tubulin was examined by immunoprecipitation and immunofluorescence . Treatment of prostate cancer patients with docetaxel led to a significant translocation of AR . In untreated specimens , 50 % prostate tumor cells exhibited nuclear accumulation of AR , compared with docetaxel-treated tumors that had significantly depleted nuclear AR ( 38 % ) , paralleled by an increase in cytosolic AR . AR nuclear localization correlated with PSA expression . In vitro , exposure of prostate cancer cells to paclitaxel ( 1 μmol/L ) or nocodazole ( 5 μg/mL ) inhibited and rogen-dependent AR nuclear translocation by targeting AR association with tubulin . Introduction of a truncated AR indicated the requirement of the NH(2)-terminal domain for AR-tubulin interaction . Our findings show that in addition to blocking cell division , docetaxel impairs AR signaling , evidence that enables new insights into the therapeutic efficacy of microtubule-targeting drugs in prostate cancer
Output:
| Compared to ADT alone , the early ( within 120 days of beginning ADT ) addition of taxane-based chemotherapy to ADT for hormone-sensitive prostate cancer probably prolongs both overall and disease-specific survival and delays disease progression .
There may be an increase in toxicity with taxane-based chemotherapy in combination with ADT . |
MS212410 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Objective : To assess effects of a combined microfinance and training intervention on HIV risk behavior among young female participants in rural South Africa . Design : Secondary analysis of quantitative and qualitative data from a cluster r and omized trial , the Intervention with Microfinance for AIDS and Gender Equity study . Methods : Eight villages were pair-matched and r and omly allocated to receive the intervention . At baseline and after 2 years , HIV risk behavior was assessed among female participants aged 14–35 years . Their responses were compared with women of the same age and poverty group from control villages . Intervention effects were calculated using adjusted risk ratios employing village level summaries . Qualitative data collected during the study explored participants ' responses to the intervention including HIV risk behavior . Results : After 2 years of follow-up , when compared with controls , young participants had higher levels of HIV-related communication ( adjusted risk ratio 1.46 , 95 % confidence interval 1.01–2.12 ) , were more likely to have accessed voluntary counseling and testing ( adjusted risk ratio 1.64 , 95 % confidence interval 1.06–2.56 ) , and less likely to have had unprotected sex at last intercourse with a nonspousal partner ( adjusted risk ratio 0.76 , 95 % confidence interval 0.60–0.96 ) . Qualitative data suggest a greater acceptance of intrahousehold communication about HIV and sexuality . Although women noted challenges associated with acceptance of condoms by men , increased confidence and skills associated with participation in the intervention supported their introduction in sexual relationships . Conclusions : In addition to impacts on economic well being , women 's empowerment and intimate partner violence , interventions addressing the economic and social vulnerability of women may contribute to reductions in HIV risk behavior Adolescents and young adults in sub-Saharan Africa ( SSA ) are particularly vulnerable to human immunodeficiency virus ( HIV ) and acquired immune deficiency syndrome ( AIDS ) infection . Adolescents orphaned as a direct result of HIV/AIDS are at an elevated risk of acquiring HIV/AIDS and other sexually transmitted infections . However , limited empirical evidence exists on HIV knowledge and prevention programs , especially those design ed to address HIV information gaps among adolescents . This study evaluates the effect of a peer mentorship program provided in addition to other supportive services on HIV/AIDS knowledge , beliefs , and prevention attitudes , among school-going orphaned adolescents in southern Ug and a. We utilize data from the Bridges to the Future Study , a 5-year longitudinal r and omized experimental study funded by the National Institute of Child Health and Human Development . Out of the 1410 adolescents enrolled in the study ( average age = 12.7 at study initiation ) , 855 of them participated in a nine-session , curriculum based peer mentorship program . We analyzed data collected at baseline and 12-months post intervention initiation . The results from bivariate and regression analysis indicate that , controlling for socioeconomic characteristics , adolescents who participated in a peer mentorship program were more likely than non- participants to report increased scores on HIV/AIDS knowledge ; better scores on desired HIV/AIDS-related beliefs ; and better scores on HIV/AIDS prevention attitudes . Overall , the study findings point to the potential role of a peer mentorship program in promoting the much-desired HIV/AIDS knowledge , beliefs , and prevention attitudes among orphaned adolescents . Future programs and policies that support AIDS-orphaned adolescents in sub-Saharan Africa should consider incorporating peer mentoring programs that provide correct , age , and culturally appropriate HIV information to help protect orphaned adolescents and reduce the risk of HIV infections OBJECTIVES The purpose of this study was to test the effects of an education program in Tanzania design ed to reduce children 's risk of human immunodeficiency virus ( HIV ) infection and to improve their tolerance of and care for people with acquired immunodeficiency syndrome ( AIDS ) . METHODS A r and omized controlled community trial including baseline and 12-month follow-up surveys was employed . Public primary schools in the Arusha and Kilimanjaro regions of Tanzania were stratified according to location and r and omly assigned to intervention ( n = 6 ) or comparison ( n = 12 ) conditions . Of the 1063 sixth- grade students ( average age : 13.6 years ) who participated at baseline , 814 participated in the follow-up survey . RESULTS At follow-up , statistically significant effects favoring the intervention group were observed for exposure to AIDS information and communication , AIDS knowledge , attitudes toward people with AIDS , and subjective norms and behavioral intentions toward having sexual intercourse . A consistent positive but nonsignificant trend was seen for attitudes toward having sexual intercourse and for initiation of sexual intercourse during the previous year ( 7 % vs 17 % ) . CONCLUSIONS It is feasible and effective to train local teachers and health workers to provide HIV/AIDS education to Tanzanian primary school children BACKGROUND Intimate partner violence ( IPV ) is associated with HIV infection . We aim ed to assess whether provision of a combination of IPV prevention and HIV services would reduce IPV and HIV incidence in individuals enrolled in the Rakai Community Cohort Study ( RCCS ) , Rakai , Ug and a. METHODS We used pre-existing clusters of communities r and omised as part of a previous family planning trial in this cohort . Four intervention group clusters from the previous trial were provided st and ard of care HIV services plus a community-level mobilisation intervention to change attitudes , social norms , and behaviours related to IPV , and a screening and brief intervention to promote safe HIV disclosure and risk reduction in women seeking HIV counselling and testing services ( the Safe Homes and Respect for Everyone [ SHARE ] Project ) . Seven control group clusters ( including two intervention groups from the original trial ) received only st and ard of care HIV services . Investigators for the RCCS did a baseline survey between February , 2005 , and June , 2006 , and two follow-up surveys between August , 2006 , and April , 2008 , and June , 2008 , and December , 2009 . Our primary endpoints were self-reported experience and perpetration of past year IPV ( emotional , physical , and sexual ) and laboratory-based diagnosis of HIV incidence in the study population . We used Poisson multivariable regression to estimate adjusted prevalence risk ratios ( aPRR ) of IPV , and adjusted incidence rate ratios ( aIRR ) of HIV acquisition . This study was registered with Clinical Trials.gov , number NCT02050763 . FINDINGS Between Feb 15 , 2005 , and June 30 , 2006 , we enrolled 11 448 individuals aged 15 - 49 years . 5337 individuals ( in four intervention clusters ) were allocated into the SHARE plus HIV services group and 6111 individuals ( in seven control clusters ) were allocated into the HIV services only group . Compared with control groups , individuals in the SHARE intervention groups had fewer self-reports of past-year physical IPV ( 346 [ 16 % ] of 2127 responders in control groups vs 217 [ 12 % ] of 1812 responders in intervention groups ; aPRR 0·79 , 95 % CI 0·67 - 0·92 ) and sexual IPV ( 261 [ 13 % ] of 2038 vs 167 [ 10 % ] of 1737 ; 0·80 , 0·67 - 0·97 ) . Incidence of emotional IPV did not differ ( 409 [ 20 % ] of 2039 vs 311 [ 18 % ] of 1737 ; 0·91 , 0·79 - 1·04 ) . SHARE had no effect on male-reported IPV perpetration . At follow-up 2 ( after about 35 months ) the intervention was associated with a reduction in HIV incidence ( 1·15 cases per 100 person-years in control vs 0·87 cases per 100 person-years in intervention group ; aIRR 0·67 , 95 % CI 0·46 - 0·97 , p=0·0362 ) . INTERPRETATION SHARE could reduce some forms of IPV towards women and overall HIV incidence , possibly through a reduction in forced sex and increased disclosure of HIV results . Findings from this study should inform future work toward HIV prevention , treatment , and care , and SHARE 's ecological approach could be adopted , at least partly , as a st and ard of care for other HIV programmes in sub-Saharan Africa . FUNDING Bill & Melinda Gates Foundation , US National Institutes of Health , WHO , President 's Emergency Plan for AIDS Relief , Fogarty International Center Background While the HIV epidemic is levelling off in sub-Saharan Africa , it remains at an unacceptably high level . Young people aged 15 - 24 years remain particularly vulnerable , result ing in a regional HIV prevalence of 1.4 % in young men and 3.3 % in young women . This study assesses the effectiveness of a peer-led HIV prevention intervention in secondary schools in Rw and a on young people ’s sexual behavior , HIV knowledge and attitudes . Methods In a non-r and omized longitudinal controlled trial , fourteen schools were selected in two neighboring districts in Rw and a Bugesera ( intervention ) and Rwamagana ( control ) . Students ( n = 1950 ) in eight intervention and six control schools participated in three surveys ( baseline , six and twelve months in the intervention ) . Analysis was done using linear and logistic regression using generalized estimation equations adjusted for propensity score . Results The overall retention rate was 72 % . Time trends in sexual risk behavior ( being sexually active , sex in last six months , condom use at last sex ) were not significantly different in students from intervention and control schools , nor was the intervention associated with increased knowledge , perceived severity or perceived susceptibility . It did significantly reduce reported stigma . Conclusions Analyzing this and other interventions , we identified several reasons for the observed limited effectiveness of peer education : 1 ) intervention activities ( spreading information ) are not tuned to objectives ( changing behavior ) ; 2 ) young people prefer receiving HIV information from other sources than peers ; 3 ) outcome indicators are not adequate and the context of the relationship in which sex occurs and the context in which sex occurs is ignored . Effectiveness of peer education may increase through integration in holistic interventions and redefining peer educators ’ role as focal points for sensitization and referral to experts and services . Finally , we argue that a narrow focus on sexual risks will never significantly turn the tide Objective To assess the impact of Stepping Stones , a HIV prevention programme , on incidence of HIV and herpes simplex type 2 ( HSV-2 ) and sexual behaviour . Design Cluster r and omised controlled trial . Setting 70 villages ( clusters ) in the Eastern Cape province of South Africa . Participants 1360 men and 1416 women aged 15 - 26 years , who were mostly attending schools . Intervention Stepping Stones , a 50 hour programme , aims to improve sexual health by using participatory learning approaches to build knowledge , risk awareness , and communication skills and to stimulate critical reflection . Villages were r and omised to receive either this or a three hour intervention on HIV and safer sex . Interviewers administered question naires at baseline and 12 and 24 months and blood was tested for HIV and HSV-2 . Main outcome measures Primary outcome measure : incidence of HIV . Other outcomes : incidence of HSV-2 , unwanted pregnancy , reported sexual practice s , depression , and substance misuse . Results There was no evidence that Stepping Stones lowered the incidence of HIV ( adjusted incidence rate ratio 0.95 , 95 % confidence interval 0.67 to 1.35 ) . The programme was associated with a reduction of about 33 % in the incidence of HSV-2 ( 0.67 , 0.46 to 0.97 ; P=0.036)—that is , Stepping Stones reduced the number of new HSV-2 infections over a two year period by 34.9 ( 1.6 to 68.2 ) per 1000 people exposed . Stepping Stones significantly improved a number of reported risk behaviours in men , with a lower proportion of men reporting perpetration of intimate partner violence across two years of follow-up and less transactional sex and problem drinking at 12 months . In women desired behaviour changes were not reported and those in the Stepping Stones programme reported more transactional sex at 12 months . Conclusion Stepping Stones did not reduce incidence of HIV but had an impact on several risk factors for HIV — notably , HSV-2 and perpetration of intimate partner violence . Trial Registration Clinical Trials NCT00332878 Background HIV-1 control in sub-Saharan Africa requires cost-effective and sustainable programmes that promote behaviour change and reduce cofactor sexually transmitted infections ( STIs ) at the population and individual levels . Methods and Findings We measured the feasibility of community-based peer education , free condom distribution , income-generating projects , and clinic-based STI treatment and counselling services and evaluated their impact on the incidence of HIV-1 measured over a 3-y period in a cluster-r and omised controlled trial in eastern Zimbabwe . Analysis of primary outcomes was on an intention-to-treat basis . The income-generating projects proved impossible to implement in the prevailing economic climate . Despite greater programme activity and knowledge in the intervention communities , the incidence rate ratio of HIV-1 was 1.27 ( 95 % confidence interval [ CI ] 0.92–1.75 ) compared to the control communities . No evidence was found for reduced
Output:
| Conclusion Peer-education-based interventions appear to be particularly effective in facilitating the uptake of HIV-related knowledge , particularly pertaining to transmission routes . |
MS212411 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND In a phase 1 - 2 trial of albumin-bound paclitaxel ( nab-paclitaxel ) plus gemcitabine , substantial clinical activity was noted in patients with advanced pancreatic cancer . We conducted a phase 3 study of the efficacy and safety of the combination versus gemcitabine monotherapy in patients with metastatic pancreatic cancer . METHODS We r and omly assigned patients with a Karnofsky performance-status score of 70 or more ( on a scale from 0 to 100 , with higher scores indicating better performance status ) to nab-paclitaxel ( 125 mg per square meter of body-surface area ) followed by gemcitabine ( 1000 mg per square meter ) on days 1 , 8 , and 15 every 4 weeks or gemcitabine monotherapy ( 1000 mg per square meter ) weekly for 7 of 8 weeks ( cycle 1 ) and then on days 1 , 8 , and 15 every 4 weeks ( cycle 2 and subsequent cycles ) . Patients received the study treatment until disease progression . The primary end point was overall survival ; secondary end points were progression-free survival and overall response rate . RESULTS A total of 861 patients were r and omly assigned to nab-paclitaxel plus gemcitabine ( 431 patients ) or gemcitabine ( 430 ) . The median overall survival was 8.5 months in the nab-paclitaxel-gemcitabine group as compared with 6.7 months in the gemcitabine group ( hazard ratio for death , 0.72 ; 95 % confidence interval [ CI ] , 0.62 to 0.83 ; P<0.001 ) . The survival rate was 35 % in the nab-paclitaxel-gemcitabine group versus 22 % in the gemcitabine group at 1 year , and 9 % versus 4 % at 2 years . The median progression-free survival was 5.5 months in the nab-paclitaxel-gemcitabine group , as compared with 3.7 months in the gemcitabine group ( hazard ratio for disease progression or death , 0.69 ; 95 % CI , 0.58 to 0.82 ; P<0.001 ) ; the response rate according to independent review was 23 % versus 7 % in the two groups ( P<0.001 ) . The most common adverse events of grade 3 or higher were neutropenia ( 38 % in the nab-paclitaxel-gemcitabine group vs. 27 % in the gemcitabine group ) , fatigue ( 17 % vs. 7 % ) , and neuropathy ( 17 % vs. 1 % ) . Febrile neutropenia occurred in 3 % versus 1 % of the patients in the two groups . In the nab-paclitaxel-gemcitabine group , neuropathy of grade 3 or higher improved to grade 1 or lower in a median of 29 days . CONCLUSIONS In patients with metastatic pancreatic adenocarcinoma , nab-paclitaxel plus gemcitabine significantly improved overall survival , progression-free survival , and response rate , but rates of peripheral neuropathy and myelosuppression were increased . ( Funded by Celgene ; Clinical Trials.gov number , NCT00844649 . ) Purpose FOLFIRINOX ( FFN ) , nab-paclitaxel plus gemcitabine ( GN ) , and gemcitabine are three systemic therapies that provide clinical ly meaningful benefit to patients with unresectable pancreatic cancer ( UPC ) . There are no clinical trials that directly compare the efficacy of all three regimens . In this study , we aim to examine and compare the real-world effectiveness of these treatments . Methods Patients diagnosed with UPC who initiated palliative chemotherapy from August 2014 to January 2016 at any one of six cancer centers in British Columbia were identified from the provincial pharmacy . Clinical , pathological , treatment , and outcome characteristics were compared . Results Two hundred twenty-five patients were included : 55 % men , 68 % Eastern Cooperative Oncology Group 0/1 , 58 % metastatic disease . Patients who received FFN were younger ( p < 0.001 ) and in better performance status ( p < 0.001 ) . Patients treated with FFN or GN experienced significantly longer median overall survival ( OS ) when compared to those treated with gemcitabine ( 14.1 vs 10.5 vs 4.2 months , respectively , p < 0.001 ) . Progression-free survival ( PFS ) was also longer among patients on FFN or GN in comparison to gemcitabine ( FFN , HR 0.44 , 95 % CI 0.24 to 0.814 , p = 0.008 ; GN , HR 0.30 , 95 % CI 0.19 to 0.47 , p < 0.001 ) . A significantly higher proportion of patients require two or more dose modifications on FFN ( 40 % ) compared to GN ( 14 % ) or gemcitabine ( 9 % ) ( p < 0.001 ) . Conclusions Receipt of modified FFN and GN portends a better prognosis than gemcitabine alone . In the absence of a r and omized comparison of all three regimens , our population -based study reveals that the introduction of modified FFN and GN confers real-world effectiveness for UPC patients PURPOSE Gemcitabine plus nanoparticle albumin-bound ( NAB ) paclitaxel ( GA ) significantly improved survival compared with gemcitabine alone in patients with metastatic pancreatic ductal adenocarcinoma ( PDAC ) and a Karnofsky performance status ( PS ) of 70 % or greater . Because of the low number of patients with reduced PS , the efficacy of this regimen in fragile patients remains unclear . This study aim ed to evaluate the efficacy and tolerability of different GA dosing regimens in patients with a poor PS . PATIENTS AND METHODS In the phase I part of this study , patients were r and omly assigned to one of the following four parallel GA treatment arms ( six patients per arm ) : a biweekly schedule of NAB-paclitaxel ( 150 mg/m2 [ arm A ] or 125 mg/m2 [ arm C ] ) plus gemcitabine 1,000 mg/m2 or a st and ard schedule of 3 weeks on and 1 week off of NAB-paclitaxel ( 100 mg/m2 [ arm B ] or 125 mg/m2 [ arm D ] ) plus gemcitabine 1,000 mg/m2 . The two regimens with the better tolerability profile on the basis of predefined criteria were evaluated in the phase II part of the study , the primary end point of which was 6-month actuarial survival . RESULTS Arms B and D were selected for the phase II part of the study . A total of 221 patients ( 111 patients in arm B and 110 patients in arm D ) were enrolled . Baseline characteristics including median age ( 71 and 68 years in arms B and D , respectively ) , sex ( 51 % and 55 % men in arms B and D , respectively ) , and metastatic disease ( 88 % and 84 % in arms B and D , respectively ) were comparable between arms . The most frequent grade 3 or 4 toxicities in arms B and D were anemia ( 12 % and 7 % , respectively ) , neutropenia ( 32 % and 30 % , respectively ) , thrombocytopenia ( 7 % and 11 % , respectively ) , asthenia ( 14 % and 16 % , respectively ) , and neurotoxicity ( 11 % and 16 % , respectively ) . In arms B and D , there were no significant differences in response rate ( 24 % and 28 % , respectively ) , median progression-free survival ( 5.7 and 6.7 months , respectively ) , and 6-month overall survival ( 63 % and 69 % , respectively ) . CONCLUSION NAB-paclitaxel administered at either 100 and 125 mg/m2 in combination with gemcitabine on days 1 , 8 , and 15 every 28 days is well tolerated and results in acceptable safety and efficacy in patients with metastatic pancreatic ductal adenocarcinoma and a poor PS BACKGROUND Among patients with metastatic pancreatic cancer , combination chemotherapy with fluorouracil , leucovorin , irinotecan , and oxaliplatin ( FOLFIRINOX ) leads to longer overall survival than gemcitabine therapy . We compared the efficacy and safety of a modified FOLFIRINOX regimen with gemcitabine as adjuvant therapy in patients with resected pancreatic cancer . METHODS We r and omly assigned 493 patients with resected pancreatic ductal adenocarcinoma to receive a modified FOLFIRINOX regimen ( oxaliplatin [ 85 mg per square meter of body‐surface area ] , irinotecan [ 180 mg per square meter , reduced to 150 mg per square meter after a protocol ‐specified safety analysis ] , leucovorin [ 400 mg per square meter ] , and fluorouracil [ 2400 mg per square meter ] every 2 weeks ) or gemcitabine ( 1000 mg per square meter on days 1 , 8 , and 15 every 4 weeks ) for 24 weeks . The primary end point was disease‐free survival . Secondary end points included overall survival and safety . RESULTS At a median follow‐up of 33.6 months , the median disease‐free survival was 21.6 months in the modified‐FOLFIRINOX group and 12.8 months in the gemcitabine group ( stratified hazard ratio for cancer‐related event , second cancer , or death , 0.58 ; 95 % confidence interval [ CI ] , 0.46 to 0.73 ; P<0.001 ) . The disease‐free survival rate at 3 years was 39.7 % in the modified‐FOLFIRINOX group and 21.4 % in the gemcitabine group . The median overall survival was 54.4 months in the modified‐FOLFIRINOX group and 35.0 months in the gemcitabine group ( stratified hazard ratio for death , 0.64 ; 95 % CI , 0.48 to 0.86 ; P=0.003 ) . The overall survival rate at 3 years was 63.4 % in the modified‐FOLFIRINOX group and 48.6 % in the gemcitabine group . Adverse events of grade 3 or 4 occurred in 75.9 % of the patients in the modified‐FOLFIRINOX group and in 52.9 % of those in the gemcitabine group . One patient in the gemcitabine group died from toxic effects ( interstitial pneumonitis ) . CONCLUSIONS Adjuvant therapy with a modified FOLFIRINOX regimen led to significantly longer survival than gemcitabine among patients with resected pancreatic cancer , at the expense of a higher incidence of toxic effects . ( Funded by R&D Unicancer and others ; Clinical Trials.gov number , NCT01526135 ; EudraCT number , 2011‐002026‐52 .
Output:
| Conclusions : Although FOLFIRINOX was associated with slightly longer median OS in more studies , the differences , when available , were not statistically significant . |
MS212412 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: 54 patients with venographically verified deep venous thrombosis ( DVT ) were r and omized to treatment with either intravenous infusions of 240 anti-Xa U/kg/12 h unfractionated heparin ( UFH ) or 240 or 120 anti-Xa U/kg/12 h of the low molecular weight heparin Fragmin . Repeated venographies showed improvement in 48 % of the UFH-treated patients and 50 and 77 % , respectively , in the Fragmin-treated patients . Progression was seen only in the UFH-treated patients and was observed in 11 % . Two bleeding complications were seen in the Fragmin group in 2 patients receiving the very high dose of 240 anti-Xa U/kg/12 h. Anti-Xa activity in plasma and activated partial thromboplastin time ( APTT ) does not correlate in the Fragmin-treated patients . Fragmin was as effective as UFH in preventing the progress of thrombosis in DVT . In another study 120 anti-Xa U/kg Fragmin given subcutaneously 2 times daily to 13 patients with DVT result ed in adequate anti-Xa activity but with a tendency for accumulation of the Fragmin-induced activity . Subcutaneous injections of Fragmin 2 times daily also appears to prevent the progression of thrombosis effectively INTRODUCTION Trials comparing the use of full dose unfractionated heparin ( UFH ) or low molecular weight heparins ( LMWHs ) in very elderly patients with impaired renal function are lacking . IRIS aim ed to assess whether LMWH is at least as safe as UFH in this population . MATERIAL S AND METHODS The study included renally impaired patients ≥70 years with acute symptomatic lower limb deep vein thrombosis ( DVT ) . Patients were r and omized to initial treatment with either tinzaparin 175 IU/kg once daily ( n=269 ) or activated partial thromboplastin time-adjusted UFH twice daily ( n=270 ) . After acute management both groups received vitamin K antagonist to day 90 . RESULTS The trial was stopped prematurely due to a difference in mortality favoring the UFH group ( 11.5 vs. 6.3 % ; p=0.035 ) . Rates of clinical ly relevant bleedings by day 90 were similar in the tinzaparin ( 11.9 % ) and UFH ( 11.9 % ) groups , as were rates of confirmed recurrent venous thromboembolism ( VTE ) ( 2.6 vs. 1.1 % ; p=0.34 ) . As the mortality difference could not be explained by bleedings or recurrent VTE , a post-hoc analysis was performed . This identified six baseline characteristics significantly correlated with mortality , of which five were over-represented in the tinzaparin group . CONCLUSION The IRIS study was a challenging study involving patients ( mean age 83 years ) usually excluded from clinical studies , but its early termination has left questions unanswered . The mortality difference observed with tinzaparin vs. UFH in elderly , renally-impaired patients with DVT can not be explained on the basis of bleedings or recurrent VTE , and may reflect an imbalance of mortality risk factors at baseline Intravenous heparin followed by oral anticoagulant therapy ( e. g. with coumarin ) is still the most widely used treatment for deep venous thromboembolism . Self-administered subcutaneous injections of heparin have been thought of as a promising alternative to coumarin , but the high doses required for ongoing prophylaxis have raised concerns about the possible development of bone disease . Certainly , long-term heparin therapy has been reported to cause osteoporosis in both laboratory animals and humans . This study aim ed to compare the efficacy and safety of unfractionated ( UF ) heparin with that of a low molecular weight heparin ( Fragmin , Kabi Pharmacia ) in the prevention of recurrent deep venous thrombosis ( DVT ) and pulmonary embolism ( PE ) in a consecutive series of patients with contraindications to coumarin therapy . The patients comprised 40 men and 40 women , aged between 19 and 92 years ( mean age , 68 years ) . They had all previously been diagnosed as having acute DVT and had been treated with conventional doses of heparin while in hospital . All patients had at least one of the following conditions : recent blood loss ( either spontaneous or during admission while receiving heparin therapy ) ; active gastroduodenal ulcer disease ; psychological or physical inability or unwillingness to underst and and accept the need for regular laboratory monitoring during coumarin treatment ; chronic alcoholism ; dementia ; pregnancy ; recent neurosurgery , and pericardial effusion ; or were over 80 years of age . They were r and omly allocated to receive either UF heparin , 10,000 IU s.c . b.d . , or Fragmin , 5000 IU anti-Factor Xa s.c . b.d . , for a period of 3 - 6 months . ( ABSTRACT TRUNCATED AT 250 WORDS Low molecular weight heparin fractions have been demonstrated as efficient as low doses of st and ard heparin in preventing post-operative deep-vein thrombosis . Several clinical studies are , now , carrying out in patients with acute deep-vein thrombosis in order to assess efficacy and safety of low molecular weight heparin fractions as compared to st and ard heparin . In a r and omised study including patients with deep-vein thrombosis treated either with low molecular weight heparin or with subcutaneously st and ard heparin , we demonstrated an effectiveness , in terms of thrombus reduction , of low molecular weight heparin as well as st and ard heparin . However , low molecular weight heparin seemed to be safer than st and ard heparin STUDY OBJECTIVE To determine the efficacy and safety of adjusted subcutaneous calcium heparin compared with continuous intravenous calcium heparin as the initial treatment for acute deep vein thrombosis . DESIGN R and omized control trial . SETTING University-affiliated general hospital . PATIENTS Of 111 consecutive patients considered , 103 had acute proximal or calf vein thrombosis confirmed by ascending venography and met all other eligibility criteria . INTERVENTIONS PATIENTS were r and omly assigned to receive subcutaneous or intravenous heparin . The subcutaneous regimen consisted of an initial dose of 15,000 U , adjusted thereafter to prolong the activated partial thromboplastin time to 50 to 70 seconds . The continuous intravenous regimen was begun as a bolus injection of 5000 U , followed by an infusion of 1250 U/h , adjusted to maintain the activated partial thromboplastin time at 50 to 70 seconds . MEASUREMENTS AND MAIN RESULTS There was no significant difference in the rate of new pulmonary embolism between the two groups , as defined by new high-probability defect on repeat ventilation-perfusion scintigrams of the lung in 96 ( 93 % ) of the patients after 7 to 10 days of treatment . Five of forty-seven patients in the subcutaneous group and 5 of 49 in the intravenous group developed pulmonary embolism ( 95 % confidence interval [ CI ] for the difference , -13.1 % to 12.2 % ) . Similarly , there was no significant difference in the frequency of hemorrhagic complications . Five of fifty-one patients in the subcutaneous group and 5 of 52 in the intravenous group had hemorrhagic complications ( 95 % CI for the difference , -11.2 % to 11.6 % ) . CONCLUSION Adjusted subcutaneous calcium heparin may be an effective and safe alternative to continuous intravenous calcium heparin in the initial treatment of acute proximal deep vein thrombosis Summary Two studies have been done to establish recommendations for dosage and dose adjustment in the treatment of deep vein thrombosis ( DVT ) with low molecular weight heparin ( LMWH ) . In the first , 56 patients were r and omized in a double blind study to be treated either with unfractionated heparin ( UFH ) or LMWH s. c. every 12 h. Initial doses were given according to age and sex , disregarding bodyweight , and the dose was then adjusted when the peak plasma heparin concentration fell outside the desired range of 0.5–0.8 anti-FXa U/ml . There were fewer dose adjustments in the LMWH group . The correlation between injected dose ( U/kg bodyweight ) and the heparin concentration was higher in the LMWH group ( r=0.59 ) than in the UFH group ( r=0.38 ) . The results suggest that , in order to obtain the desired heparin concentration , the initial dose of LMWH should be about 100 U/kg bodyweight every 12 h . In the second , open study , this dosage plan was followed in 15 patients . The peak heparin concentration on Day 2 ranged from 0.40 to 0.75 anti-FXa U/ml and adjustment was only required in 3 patients . Day to day variation in peak heparin activity in the individual patient varied little ( CV 11–22 % ) , and there was no accumulation . The results indicate that plasma heparin concentration is more predictable using LMWH than UFH , and they point to definite advantages in the use of LMWH in a bodyweight adjusted dosage Ninety-four patients with deep vein thrombosis of inferior limbs were r and omly allocated to receive sodium heparin either by subcutaneous injections or by continuous intravenous infusion for six days . No significant difference was observed in the therapeutic efficiency as judged by phlebographic examinations and in rate of symptomatic pulmonary embolism between the two groups . There was one instance of major bleeding in the subcutaneous group . Minor bleedings occurred in 10 of the 48 patients treated with subcutaneous heparin and in 13 of the 46 patients receiving intravenous heparin . The results showed that subcutaneous injections of sodium heparin are as effective and safe as continuous intravenous infusion of this drug in the treatment of deep vein thrombosis BACKGROUND Few reports have addressed the value of unfractionated heparin ( UFH ) or low-molecular-weight heparin in treating the full spectrum of patients with venous thromboembolism ( VTE ) , including recurrent VTE and pulmonary embolism . METHODS In an open , multicenter clinical trial , 720 consecutive patients with acute symptomatic VTE , including 119 noncritically ill patients ( 16.5 % ) with pulmonary embolism and 102 ( 14.2 % ) with recurrent VTE , were r and omly assigned to treatment with subcutaneous UFH with dose adjusted by activated partial thromboplastin time by means of a weight-based algorithm ( preceded by an intravenous loading dose ) , or fixed-dose ( adjusted only to body weight ) subcutaneous nadroparin calcium . Oral anticoagulant therapy was started concomitantly and continued for at least 3 months . We recorded the incidence of major bleeding during the initial heparin treatment and that of recurrent VTE and death during 3 months of follow-up . RESULTS Fifteen ( 4.2 % ) of the 360 patients assigned to UFH had recurrent thromboembolic events , as compared with 14 ( 3.9 % ) of the 360 patients assigned to nadroparin ( absolute difference between rates , 0.3 % ; 95 % confidence interval , -2.5 % to 3.1 % ) . Four patients assigned to UFH ( 1.1 % ) and 3 patients assigned to nadroparin ( 0.8 % ) had episodes of major bleeding ( absolute difference between rates , 0.3 % ; 95 % confidence interval , -1.2 % to 1.7 % ) . Overall mortality was 3.3 % in each group . CONCLUSIONS Subcutaneous UFH with dose adjusted by activated partial thromboplastin time by means of a weight-based algorithm is as effective and safe as fixed-dose nadroparin for the initial treatment of patients with VTE , including those with pulmonary embolism and recurrent VTE One hundred patients with phlebographically proved acute deep vein thrombosis of the legs were prospect ively r and omised into two treatment groups to compare the safety and efficacy of subcutaneous calcium heparin versus intravenous sodium heparin administered by constant infusion pump . The dose of heparin was determined by daily measurement of the kaolin cephalin clotting time . Treatment was maintained for up to 14 days , after which phlebography was repeated . Of 49 patients who received subcutaneous calcium heparin , two showed an increase in thrombus size , while eight showed complete lysis . In the 47 patients who received intravenous sodium heparin thrombus increased in size in 13 while only one showed evidence of complete lysis . These differences were significant . There were no significant differences between the two groups in the incidence of serious complications , although almost half of those receiving intravenous heparin had some minor problem with the constant infusion pump and just over half of those receiving subcutaneous heparin had some bruising at the injection site . This study showed that subcutaneous calcium heparin was more effective in helping lyse existing thrombus and preventing its propagation than intravenous sodium heparin 48 patients with acute deep venous thrombosis of the lower limbs were treated with sodium he
Output:
| There is no evidence of a difference between subcutaneous versus intravenous UFH for preventing VTE recurrence , VTE-related or all-cause mortality , and major bleeding .
There is also no evidence of a difference between subcutaneous UFH and LMWH for preventing VTE recurrence , VTE-related or all-cause mortality or major bleeding |
MS212413 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: AIMS Despite widespread prevention efforts to decrease adolescent risk-taking , substance use and driving after drinking ( DD ) are prevalent in the United States . The current study compared the efficacy of an abbreviated version of Drug Abuse and Resistance Education ( DARE-A ) to a new Risk Skills Training Program ( RSTP ) . DESIGN Adolescent participation in drinking , drug use , DD and riding with a drunk driver was examined longitudinally . After baseline assessment s , adolescents were r and omly assigned to the RSTP . DARE-A or a no intervention control group and then completed 2-month post-test and 6-month follow-up assessment s. SETTING Adolescents attended a mid-sized suburban high school . PARTICIPANTS The sample ( N = 300 ) was comprised of 58 % females and the age range was 14 - 19 years . INTERVENTION The RSTP was developed to target several risk behaviors and to examine the feasibility of conducting a brief personalized prevention program in a group setting . DARE-A focused on increasing knowledge and underst and ing the deleterious effects of substance use . MEASUREMENTS Risk-taking behavior , perception of peer risk-taking and positive and negative alcohol expectancies were assessed . FINDINGS RSTP participants decreased participation in several risk behaviors at post-test , but reductions were not maintained at 6-month follow-up . The control and DARE-A groups increased their positive and decreased their negative alcohol expectancies . The control group increased their alcohol consumption . CONCLUSIONS Results suggest that a brief , personalized , group prevention program is a feasible approach to reducing adolescent risk-taking . Strategies must be developed to solidify these positive changes so that they are longer-lasting OBJECTIVE To evaluate the effect of the middle and junior high school Drug Abuse Resistance Education ( D.A.R.E. ) and D.A.R.E. Plus programs on drug use and violence . DESIGN R and omized controlled trial of 24 schools , with 3 conditions : D.A.R.E. only , D.A.R.E. Plus , and delayed program control . SETTING Schools and neighborhoods , primarily in Minneapolis-St Paul . PARTICIPANTS All seventh- grade students in 24 schools in the academic year 1999 - 2000 ( N = 6237 at baseline , 67.3 % were white , and there was 84.0 % retention at final follow-up ) . INTERVENTIONS The middle and junior high school D.A.R.E. curriculum in the 16 schools that received D.A.R.E. only and D.A.R.E. Plus . In the 8 schoolts that received D.A.R.E. Plus , additional components included a peer-led parental involvement classroom program called " On the VERGE , " youth-led extracurricular activities , community adult action teams , and postcard mailings to parents . The interventions were implemented during 2 school years , when the cohort was in the seventh and eighth grade s. MAIN OUTCOME MEASURES Self-reported tobacco , alcohol , and marijuana use ; multidrug use ; violence ; and victimization , assessed at the beginning and end of seventh grade and at the end of eighth grade . Growth curve analytic methods were used to assess changes over time by condition . RESULTS There were no significant differences between D.A.R.E. only and the controls ; significant differences among boys between D.A.R.E. Plus and controls for tobacco , alcohol , and multidrug use and victimization ; significant differences among boys between D.A.R.E. Plus and D.A.R.E. only in tobacco use and violence ; and no significant behavioral differences among girls . CONCLUSION D.A.R.E. Plus significantly enhanced the effectiveness of the D.A.R.E. curriculum among boys and was more effective than the delayed program controls , underscoring the potential for multiyear , multicomponent prevention programs and demonstrating sex differences in response to intervention programs This study examined the effects of the Iowa Strengthening Families Program ( ISFP ) and the Preparing for the Drug-Free Years program ( PDFY ) on young adolescent transitions from nonuse of substances to initiation and progression of substance use . Analyses incorporated 3 waves of data collected over a 2.5-year period from 329 rural young adolescents . Outcomes were analyzed by using log-linear models that incorporated substance use status frequencies derived from latent transition analyses . Effects on delayed substance use initiation were shown for both the ISFP and the PDFY at a 2-year follow-up . Also at this follow-up , the PDFY showed effects on delayed progression of use among those previously reporting initiation This study examined long-term follow-up data from a large-scale r and omized trial to determine the extent to which participation in a school-based drug abuse prevention program during junior high school led to less risky driving among high school students . Self-report data collected from students in the 7th , 10th , and 12th grade s were matched by name to students ' department of motor vehicles ( DMV ) records at the end of high school . The DMV data included the total number of violations on students ' driving records as well as the number of “ points ” that indicate the frequency and severity of the violations . A series of logistic regression analyses revealed that males were more likely to have violations and points on their driving records than females , and regular alcohol users were more likely to have violations and points than those who did not use alcohol regularly . Controlling for gender and alcohol use , students who received the drug prevention program during junior high school were less likely to have violations and points on their driving records relative to control group participants that did not receive the prevention program . Findings indicated that antidrinking attitudes mediated the effect of the intervention on driving violations , but not points . These results support the hypothesis that the behavioral effects of competence-enhancement prevention programs can extend to risk behaviors beyond the initial focus of intervention , such as risky driving Abstract . Objective : The authors assessed short-term effectiveness of a Web-based alcohol education program on entering freshmen . Participants : 3,216 incoming first-year students were r and omized to a control or intervention group . Methods : Controls completed a survey and knowledge test the summer before college ; 4 to 6 weeks after arrival on campus , they completed a follow-up survey of behaviors and harms followed by an invitation to complete the online course . Intervention students completed the precourse survey and test , the online course , and final exam prior to coming to campus . This was followed by a survey 4 to 6 weeks after arrival on campus . Results : Although the intervention group showed significantly higher alcohol-related postcourse knowledge compared to the control group , protective behavior , risk-related behavior , high-risk drinking , and alcohol-related harm did not favor the intervention group , with the sole exception of playing drinking games . Conclusions : Alcohol knowledge alone was insufficient to mitigate alcohol-related high-risk behaviors in this student population AIM To evaluate the effectiveness of a school-based substance abuse prevention program developed in the EU-Dap study ( EUropean Drug Addiction Prevention trial ) . MATERIAL S AND METHODS Cluster R and omized Controlled Trial . Seven European countries participated in the study ; 170 schools ( 7079 pupils 12 - 14 years of age ) were r and omly assigned to one of three experimental conditions or to a control condition during the school year 2004/2005 . The program consisted of a 12-h curriculum based on a comprehensive social influence approach . A pre-test survey assessing past and current substance use was conducted before the implementation of the program , while a post-test survey was carried out about 18 months after the pre-test . The association between program condition and change in substance use at post-test was expressed as adjusted prevalence odds ratio ( POR ) , estimated by multilevel regression models . RESULTS Persisting beneficial program effects were found for episodes of drunkenness ( any , POR=0.80 ; 0.67 - 0.97 ; frequent , POR=0.62 ; 0.47 - 0.81 ) and for frequent cannabis use in the past 30 days ( POR=0.74 ; 0.53 - 1.00 ) , whereas daily cigarette smoking was not affected by the program as it was at the short-term follow-up . Baseline non-smokers that participated in the program progressed in tobacco consumption to a lower extent than those in the control condition , but no difference was detected in the proportion of quitters or reducers among baseline daily smokers . CONCLUSION The experimental evaluation of an innovative school curriculum based on a comprehensive social influence approach , indicated persistent positive effects over 18 months for alcohol abuse and for cannabis use , but not for cigarette smoking We report the results of a growth model analysis of the impact of a Family Empowerment Intervention ( FEI ) on the heavy drinking over a 36-month follow-up period among youths processed at the Hillsborough County Juvenile Assessment Center . Families involved in the project were r and omly assigned to either receive an Extended Services Intervention ( ESI ) or the FEI . Families in the ESI group received monthly phone contacts and , if indicated , referral information ; FEI families received three one-hour , home-based meetings per week for approximately 10 weeks from a clinician-trained paraprofessional . By seeking to improve family functioning by empowering parents , it was hypothesized that target youths ' behavior and psychosocial functioning would improve . Although the difference between FEI and ESI was not significant , the reported frequency of getting very high or drunk on alcohol declined more over time for FEI completers than FEI noncompleters . The results provide support for the impact of the FEI services Abstract Preparing for the Drug-Free Years ( PDFY ) is a curriculum design ed to help parents learn skills to consistently communicate clear norms against adolescent substance use , effectively and proactively manage their families , reduce family conflict , and help their children learn skills to resist antisocial peer influences . This study examined the effects of PDFY on the trajectories of these factors , as well as on the trajectory of alcohol use from early to mid adolescence . The sample consisted of 424 rural families of sixth grade rs from schools r and omly assigned to an intervention or a control condition . Data were collected from both parents and students at pretest , posttest , and 1- , 2- and 3 $ $ \frac{1}{2}$$ -year follow-ups . Latent growth models were examined . PDFY significantly reduced the growth of alcohol use and improved parent norms regarding adolescent alcohol use over time . Implication s for prevention and evaluation are discussed This study examined whether the efficacy of keepin ’ it REAL , a model program for substance use prevention in schools , was moderated by gender , ethnicity , and acculturation . Gender differences in program efficacy may arise through boys ' higher risk of drug use , inadequate attention to girls ' developmental issues , or cultural factors like polarized gender expectations . Data came from a r and omized trial in 35 Phoenix , Arizona , middle schools involving 4,622 mostly Latino 7th grade rs . Using multi-level mixed models and multiple imputation missing techniques , results for the total sample showed no gender differences in program effects on recent substance use , but the program was more effective in fostering boys ' than girls ' anti-drug norms . Subgroup analyses demonstrated several more beneficial program effects for boys than girls ( less alcohol and cigarette use and stronger anti-drug norms ) , but only among less acculturated Latinos . There were no gender differences in program effects among more acculturated Latinos , nor among non-Latino whites The authors evaluated the efficacy of a brief image-based prevention intervention and assessed current drug use as a moderator of intervention effects . In a clinical trial , 416 high school-age adolescents were r and omized to either the brief intervention or usual care control , with data collected at baseline and 3-month follow-up . The brief intervention consisted of a tailored in-person communication and a series of parent/guardian print material s based on the behavior-image model . Health behavior goal setting increased for participants receiving the brief intervention , with an effect size in the small range ( d = 0.33 ) . Overall effect sizes for cigarette smoking frequency and quantity and alcohol use frequency and quantity were small ( ds = 0.16 - 0.21 ) and in favor of the brief intervention . However , adolescents reporting current substance use who received the brief intervention reduced their frequency and heavy use of alcohol , frequency and quantity of cigarette smoking , and reported fewer alcohol/drug problems , with larger effects ranging from small to approaching medium in size ( ds = 0.32 - 0.43 , ps < .01 ) . This study suggests that brief image-based messages may increase health behavior goal setting and reduce substance use , particularly among drug-using older adolescents PURPOSE School-based substance abuse prevention programs are widespread but are rarely evaluated in Europe . We aim ed to evaluate the effect of a new school-based prevention program against substance use on the frequency of alcohol consumption and alcohol-related problem behaviors among European students . METHODS During the school year 2004 - 2005 , a total of 7,079 students aged 12 - 14 years from 143 schools in seven European countries participated in this cluster r and omized controlled trial . Schools were r and omly assigned to either control ( 65 schools , 3,532 students ) or to a 12-session st and ardized program based on the comprehensive social influence model ( 78 schools , 3,547 students ) . Alcohol use and frequency of alcohol-related problem behaviors were investigated through a self-completed anonymous question naire at baseline and 18 months thereafter . The association between intervention and changes in alcohol-related outcomes was expressed as odds ratio ( OR ) , estimated by multilevel regression model . RESULTS The preventive program was associated with a decreased risk of reporting alcohol-related problems ( OR = .78 , 95 % confidence intervals [ CI ] = .63-.98 ) , although this reduction was
Output:
| In 14 of the 39 trials evaluating generic interventions , the program interventions demonstrated significantly greater reductions in alcohol use either through a main or subgroup effect .
Gender , baseline alcohol use , and ethnicity modified the effects of interventions .
This review identified studies that showed no effects of preventive interventions , as well as studies that demonstrated statistically significant effects .
There was no easily discernible pattern in characteristics that would distinguish trials with positive results from those with no effects .
Most commonly observed positive effects across programs were for drunkenness and binge drinking .
Current evidence suggests that certain generic psychosocial and developmental prevention programs can be effective and could be considered as policy and practice options . |
MS212414 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Epidemiological studies have suggested that female hormones might play a role in asthma and that menopausal hormone therapy ( MHT or hormone replacement therapy ( HRT ) ) might increase the risk of asthma in postmenopausal women . The only prospect i ve study addressing this issue reports an increase in the risk of developing asthma which was similar for oestrogen alone and oestrogen/progestagen treatment . Methods The association between the use of different types of MHT and the risk of asthma onset in postmenopausal women was investigated prospect ively from 1990 to 2002 by biennial question naires as part of the French E3N cohort study . Asthma onset was considered to be the time of medical diagnosis of asthma cases occurring during the follow-up of women who were asthma free at baseline . Cox proportional hazards models were used , adjusting for potential confounding factors . Results Among 57 664 women free of asthma at menopause , 569 incident cases of asthma were identified during 495 448 years of follow-up . MHT was related to an increased risk of asthma onset ( HR=1.20 , 95 % CI 0.98 to 1.46 ) among recent users . The increase in risk of asthma onset was only significant among women reporting the use of oestrogen alone ( HR=1.54 , 95 % CI 1.13 to 2.09 ) particularly in never smokers ( HR=1.80 , 95 % CI 1.15 to 2.80 ) and women reporting allergic disease prior to asthma onset ( HR=1.86 , 95 % CI 1.18 to 2.93 ) . A small increase in the risk of asthma onset associated with the use of oestrogen/progestagen was also observed in these subgroups . Conclusion Postmenopausal use of oestrogen alone was associated with an increased rate of newly diagnosed asthma in menopausal women The protective effect of pregnancy on putative Th1-mediated autoimmune diseases , such as multiple sclerosis and rheumatoid arthritis , is associated with a Th1 to Th2 immune shift during pregnancy . The hormone estriol increases during pregnancy and has been shown to ameliorate experimental autoimmune encephalomyelitis and collagen-induced arthritis . In addition , estrogens induce cytokine changes consistent with a Th1 to Th2 shift when administered in vitro to human immune cells and in vivo to mice . In a pilot trial , oral estriol treatment of relapsing remitting multiple sclerosis patients caused significant decreases in enhancing lesions on brain magnetic resonance imaging . Here , the immunomodulatory effects of oral estriol therapy were assessed . P BMC s collected longitudinally during the trial were stimulated with mitogens , recall Ags , and glatiramer acetate . Cytokine profiles of stimulated P BMC s were determined by intracellular cytokine staining ( IL-5 , IL-10 , IL-12 p40 , TNF-α , and IFN-γ ) and cytometric bead array ( IL-2 , IL-4 , IL-5 , IL-10 , TNF-α , and IFN-γ ) . Significantly increased levels of IL-5 and IL-10 and decreased TNF-α were observed in stimulated P BMC isolated during estriol treatment . These changes in cytokines correlated with reductions of enhancing lesions on magnetic resonance imaging in relapsing remitting multiple sclerosis . The increase in IL-5 was primarily due to an increase in CD4 + and CD8 + T cells , the increase in IL-10 was primarily due to an increase in CD64 + monocytes/macrophages with some effect in T cells , while the decrease in TNF-α was primarily due to a decrease in CD8 + T cells . Further study of oral estriol therapy is warranted in Th1-mediated autoimmune diseases with known improvement during pregnancy OBJECTIVE To study whether hormone replacement therapy ( HRT ) or Tibolone has an effect on pulmonary function in postmenopausal women . METHODS Seventy-five postmenopausal women without any risk factor for pulmonary disease were included in this r and omized , prospect i ve study . Fifty women had undergone natural menopause and 25 had had a hysterectomy/ooforectomy . Twenty-five natural menopause women were r and omly allocated to two groups : 25 patients ( Group I ) were treated with Tibolone 2.5 mg/day , 25 patients ( group II ) with Estradiol Hemihidrate 2 mg+Norethindron Asetate 1 mg/day . Twenty-five induced menopause women were treated with 17 beta-estradiol 2 mg/day . Lung function tests including forced vital capacity ( FVC ) , forced expiratory volume ( FEV(1 ) ) , FEV(1)/FVC , forced expiratory flow rate over the 25 - 75 % of the forced vital capacity volume ( FEF(25 - 75 % ) ) , and peak expiratory flow rate ( PEF ) were evaluated at the beginning and 3 months after the treatment to assess the effects of HRT and Tibolone on respiratory function . RESULTS Regardless of HRT types a significant difference was observed in FVC and FEV(1 ) after 3 months of the therapy ( P=0.001 , 0.0001 , respectively ) . No significant difference was found between pre and post therapy values in the other parameters ( P>0.05 ) . CONCLUSIONS We determined a significant increase in FVC and FEV(1 ) parameters of pulmonary functions after 3 months of the therapy regardless of HRT types . Therefore , we think that HRT regimens have modifying effects on pulmonary function in postmenopausal women We prospect ively evaluated the association of hormone replacement therapy and asthma incidence in a cohort of pre- and postmenopausal women 34 to 68 yr of age . During 582 , 135 person-years of follow-up between 1980 and 1990 , 726 new cases of asthma were documented . Postmenopausal women who were never users of replacement hormones had a significantly lower age-adjusted risk of asthma than premenopausal women ( relative risk = 0.65 ; 95 % confidence interval [ CI ] = 0.46 to 0.92 ) . Among naturally menopausal women , the age-adjusted relative risk of asthma for ever use of postmenopausal hormones was 1.49 ( 95 % CI = 1.10 to 2.00 ) ; for current use of hormones ( conjugated estrogens with or without progesterone ) , 1.50 ( 95 % CI = 0.98 to 2.30 ) ; and for past use , 1.52 ( 95 % CI = 1.08 to 2.13 ) , compared with never use of hormones . Ever users of 10 or more years ' duration had twice the age-adjusted risk of asthma compared with women who never used postmenopausal hormones ( 95 % CI = 1.39 to 2.87 ) . Among current users of conjugated estrogens , there was a positive dose-response demonstrated between daily dose and asthma risk ( p for trend = 0.007 ) . While confirmatory studies are warranted , these data suggest that estrogen plays a role in the pathophysiology of asthma and that long-term use and /or high doses of postmenopausal hormone therapy increase subsequent risk of asthma Objective : To investigate the variability and determinants of menopause age in two European cohort studies , the European Respiratory Health Survey and the Swiss Air Pollution and Lung Disease in Adults Cohort . Methods : Age at menopause was estimated in 5,288 women , aged 30 to 60 years , r and omly selected in nine European countries between 1998 and 2002 . Determinants of natural and surgically induced menopause were investigated by Cox regression and heterogeneity by meta- analysis . Follicle-stimulating hormone and luteinizing hormone levels were assessed in a sub sample . Results : A quarter of the women were postmenopausal by age 50.8 years . Median age of natural menopause was 54 years . Hormone levels were within expected ranges for premenopausal and postmenopausal women . Surgically induced menopause was highly prevalent ( 22%-47 % ) , associated with earlier timing of menopause . Determinants of earlier menopause were current smoking ( hazard ratio [ HR ] , 1.59 ; 95 % CI , 1.27 - 1.98 ) , body mass index greater than 30 kg/m2 ( HR , 1.32 ; 95 % , CI , 1.02 - 1.70 ) , and low physical activity ( HR , 1.37 ; 95 % , CI , 1.12 - 1.67 ) . The determinant for later menopause was multiparity ( HR , 0.74 ; 95 % CI , 0.62 - 0.89 ) . Predictors were similar for naturally and surgically induced menopause . Oral contraceptive use yielded heterogeneous effects on timing of menopause . Later birth was associated with later menopause ( HR , 0.934 ; 95 % CI , 0.91 - 0.96 ) . This evidence of a secular trend is heterogeneous across countries . Conclusions : Age at menopause varies across Europe , shifting toward higher ages . This secular trend seems paradoxical because several adult determinants , that is , overweight , smoking , sedentarity , and nulliparity , associated with early menopause are on the rise in Europe . The heterogeneity of the secular trend suggests additional country-specific factors not included in the study , such as improved childhood nutrition and health , that have an influence on reproductive aging Abstract Objective : To assess the relation between forced expiratory volume in one second ( FEV1 ) and subsequent mortality . Design : Prospect i ve general population study . Setting : Renfrew and Paisley , Scotl and . Subjects : 7058 men and 8353 women aged 45 - 64 years at baseline screening in 1972 - 6 . Main outcome measure : Mortality from all causes , ischaemic heart disease , cancer , lung and other cancers , stroke , respiratory disease , and other causes of death after 15 years of follow up . Results : 2545 men and 1894 women died during the follow up period . Significant trends of increasing risk with diminishing FEV1 are apparent for both sexes for all the causes of death examined after adjustment for age , cigarette smoking , diastolic blood pressure , cholesterol concentration , body mass index , and social class . The relative hazard ratios for all cause mortality for subjects in the lowest fifth of the FEV1 distribution were 1.92 ( 95 % confidence interval 1.68 to 2.20 ) for men and 1.89 ( 1.63 to 2.20 ) for women . Corresponding relative hazard ratios were 1.56 ( 1.26 to 1.92 ) and 1.88 ( 1.44 to 2.47 ) for ischaemic heart disease , 2.53 ( 1.69 to 3.79 ) and 4.37 ( 1.84 to 10.42 ) for lung cancer , and 1.66 ( 1.07 to 2.59 ) and 1.65 ( 1.09 to 2.49 ) for stroke . Reduced FEV1 was also associated with an increased risk for each cause of death examined except cancer for lifelong nonsmokers . Conclusions : Impaired lung function is a major clinical indicator of mortality risk in men and women for a wide range of diseases . The use of FEV1 as part of any health assessment of middle aged patients should be considered . Smokers with reduced FEV1 should form a priority group for targeted advice to stop smoking . Key messages These increased risks , with the exception of the cancers , are apparent for lifelong non-smokers FEV1 is second in importance to cigarette smoking as a predictor of subsequent all cause mortality and is as important as cholesterol in predicting mortality from ischaemic heart disease FEV1 should be included in health assessment of middle aged men and women Smokers with a reduced FEV1 should be targeted with advice to stop BACKGROUND Data from multiple clinical , epidemiologic , and in vitro studies are conflicting regarding the effect of estrogen replacement therapy ( ERT ) on airway function in postmenopausal women with asthma . OBJECTIVE To determine the impact of withdrawal of estrogen administration in postmenopausal , asthmatic women . METHODS Twenty asthmatic women who were postmenopausal for at least 2 years and undergoing ERT were recruited for this prospect i ve crossover study . Subjects continued taking baseline estrogen for 28 days , stopped taking estrogen for 28 days , and then resumed taking the medication for 14 days . Objective measurements were obtained by recording daily peak flows in the morning and evening and formal spirometry at days 14 , 28 , 42 , 56 , and 70 . Compliance was measured by evaluating serum estradiol levels at days 28 and 56 . Daily use of short-acting beta-agonist bronchodilators was also recorded . RESULTS Differences in estradiol levels indicated compliance with the medication regimen . The combined day 14 and 28 ( taking estrogen ) mean percent predicted forced expiratory volume in 1 second (
Output:
| Evidence on menopause and asthma was conflicting , while studies on COPD were scarce .
The findings generally support an association between menopause and clinical ly significant reductions in lung function in a non-obstructive pattern .
However , the effects of menopause are clouded by aging , menopausal hormone therapy use , and increased risk of metabolic syndrome during this period . |
MS212415 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The aims of this study were : ( 1 ) to correlate surface ( SH ) and cross-sectional hardness ( CSH ) with microradiographic parameters of artificial enamel lesions ; ( 2 ) to compare lesions prepared by different protocol s. Fifty bovine enamel specimens were allocated by stratified r and omisation according to their initial SH values to five groups and lesions produced by different methods : MC gel ( methylcellulose gel/lactic acid , pH 4.6 , 14 days ) ; PA gel ( polyacrylic acid/lactic acid/hydroxyapatite , pH 4.8 , 16 h ) ; MHDP ( undersaturated lactate buffer/methyl diphosphonate , pH 5.0 , 6 days ) ; buffer ( undersaturated acetate buffer/fluoride , pH 5.0 , 16 h ) , and pH cycling ( 7 days ) . SH of the lesions ( SH1 ) was measured . The specimens were longitudinally sectioned and transverse microradiography ( TMR ) and CSH measured at 10- to 220-μm depth from the surface . Overall , there was a medium correlation but non-linear and variable relationship between mineral content and √CSH . √SH1 was weakly to moderately correlated with surface layer properties , weakly correlated with lesion depth but uncorrelated with integrated mineral loss . MHDP lesions showed the highest subsurface mineral loss , followed by pH cycling , buffer , PA gel and MC gel lesions . The conclusions were : ( 1 ) CSH , as an alternative to TMR , does not estimate mineral content very accurately , but gives information about mechanical properties of lesions ; ( 2 ) SH should not be used to analyse lesions ; ( 3 ) artificial caries lesions produced by the protocol s differ , especially considering the method of analysis This paper describes a microradiographic method for measuring mineral concentration in a transversal geometry with thick ( ≤3.2 mm ) sections : transversal wavelength-independent microradiography ( T-WIM ) . It was tested on bovine enamel and dentin sample s in vitro , and the results were vali date d with those of transversal microradiography ( TMR ) . 48 enamel and 48 dentin sample s ( 3.2 × 3.2 × 1.5 mm ) were embedded in acrylic resin , r and omly divided into six groups of 8 dentin or 8 enamel sample s , and demineralized for 0 ( sound control ) , 1 , 2 , 3 , 4 , or 5 weeks . For T-WIM , sample s were imaged on film with polychromatic 40-kV Cu X-rays with an Al ( 0.25 mm)/Ni ( 0.02 mm ) filter together with an aluminium/zinc step wedge . TMR slices ( about 80 µm for enamel and about 130 µm for dentine ) were subsequently cut from the centre of the sample s and subjected to TMR . Microradiographs from both methods were digitized and image analysis software was used to calculate lesion depth and mineral loss . The relations between T-WIM and TMR results for mineral loss ( ΔZ ) and lesion depth were nearly linear ( r ≧ 0.96 ) for both enamel and dentin . The slopes of the regression lines were between 0.99 and 1.02 except for ΔZ in dentine , which was 0.89 . It was concluded that T-WIM is a suitable method for TMR on thick sample PURPOSE To evaluate the in situ effect of fluoride and MDPB-containing adhesives on antibacterial activity around restorations in conditions of high caries risk . METHODS Bovine enamel and dentin blocks were restored with a fluoride-containing ( One-up Bond F Plus - OP ) or a MDPB and fluoride-containing adhesive ( Clearfil Protect Bond - PB ) . Volunteers ( n = 17 ) wore an intra-oral appliance containing three enamel and three dentin blocks , aligned side-by-side and restored with OP or PB and one enamel and dentin block ( controls ) . The cariogenic challenge was carried out in two phases of 14 days each . The counts of total streptococci ( TM ) , mutans streptococci ( MS ) and lactobacilli ( LB ) were analyzed in the biofilm formed . Cross-sectional microhardness ( CSM ) and polarized light microscopy ( PLM ) evaluated caries lesions around the restorations and the demineralization extension . Data obtained by CSM testing was analyzed by Split-Split Plot ANOVA ( P < 0.05 ) . PLM and microbiota results were analyzed by Wilcoxon test ( P < 0.05 ) . RESULTS TM and MS counts were highest for the OP enamel restorations , and these presented higher lesion depths than PB in both the enamel and dentin . The CSM in dentin was the lowest at 60 μm from the restoration wall . None of the adhesives prevented demineralization and bacteria growth , but PB reduced the amount of oral pathogens in enamel and demineralization around restorations in enamel and dentin This study evaluates in situ the effect of erbium-doped yttrium aluminum garnet ( Er : YAG ) laser parameters on the development of caries-like lesions adjacent to dental restorations . One hundred fifty bovine enamel slabs were r and omly allocated among 15 volunteers . The specimens were subdivided into ten groups : nine experimental groups prepared with Er : YAG laser ( 300 mJ output , frequency of 2 , 4 or 6 Hz , water flow rate of 2.0 , 5.0 , or 8.0 mL/min ) and one control group ( high-speed h and piece ) . The prepared cavity was restored with a composite resin , and the slabs were mounted on palatal appliance to be installed in the volunteers to the cariogenic challenge . After this , the specimens were sectioned to the longitudinal microhardness measurements . Data were su bmi tted to Friedman and Wilcoxon paired tests . All groups prepared with Er : YAG laser demonstrated microhardness values higher than those prepared with high-speed h and piece , which showed the lowest microhardness values ( 24.86 ) . The group prepared with Er : YAG laser ( 2 Hz–2.0 mL/min ) showed the highest microhardness values ( 152.43 ) , followed by those prepared with Er : YAG laser ( 2 Hz–5.0 mL/min ) ( 133.08 ) and Er : YAG laser ( 2 Hz–8.0 mL/min ) ( 91.61 ) , respectively . The groups Er : YAG laser with 4 and 6 Hz of frequency and water flow rates of 2.0 , 5.0 , and 8.0 mL/min showed microhardness values lower than the groups cited above and showed statistical similarity among them . The Er : YAG laser parameters employed to cavity preparation influenced the acid resistance of the irradiated substrate , and the Er : YAG laser was capable to control the development of caries-like lesions around composite resin restorations PURPOSE To investigate in situ the influence of gaps in the development of secondary caries lesion in adhesive restorations . METHODS 10 volunteers utilized intra-oral appliances , containing three human dental blocks ( enamel and dentin ) , representing the three different groups ( two restored , one sound ) : ( 1 ) restored with resin composite using the total acid etch adhesive technique ( 37 % H3PO4 + Single Bond + Z250 ) ; ( 2 ) restored with resin composite but without acid etching ( Single Bond + Z250 ) ; ( 3 ) and sound blocks ( control group ) . The dental blocks ( n=30 ) were r and omly positioned inside the intra-oral appliances , and covered by a porous tissue ( gabardine base ) to induce a cariogenic biofilm . The volunteers used the appliances 24 hours daily for a 28-day period , removing just during meals and oral hygiene . Eight times a day , a 20 % sucrose solution was dripped onto the blocks . Five minutes later , the appliance was washed with distilled water and replaced in the oral environment . After the experimental period , the dental blocks were removed from the appliance and examined by visual examination to detect the presence or the absence of an active carious lesion ( kappa= 0.89 ) . Posteriorly , they were prepared for the polarized light microscopy examination , which was performed to describe enamel surface characteristics on the restored and unrestored blocks with active caries lesion ( kappa= 1 ) . RESULTS The visual examination demonstrated that almost all ( 29/30 ) of the blocks showed non-cavitated active caries lesion on the enamel surface . The microscopic evaluation showed non-cavitated caries lesions on enamel surfaces for all groups . In the restored blocks ( with and without the total etch technique ) , the demineralization was first identified as an outer lesion that follows the enamel prism directions , and in some cases , reached the cavity walls . The results showed that caries lesion development adjacent to the restoration was determined by the cariogenic challenge of the oral environment , instead of the restoration adhesive quality , and the wall lesion was determined by the prism orientation , regardless of the presence of gaps OBJECTIVE This study assessed the effect of the Er : YAG laser on enamel adjacent to restorations su bmi tted to cariogenic challenge in situ , by microhardness analysis . BACKGROUND DATA The influence of Er : YAG laser energy on secondary caries formation has been investigated in vitro . However , no research involving demineralization around cavities prepared with the Er : YAG laser under intra-oral conditions has yet been described . MATERIAL S AND METHODS Slabs of enamel were r and omly assigned to seven groups ( n = 12 ) , according to the cavity preparation technique : groups I , II , and III -- Er : YAG laser , 250 mJ , at 2 , 3 , and 4 Hz , respectively ; groups IV , V , and VI--350 mJ , at 2 , 3 , and 4 Hz , respectively ; group VII -- high-speed h and piece ( control ) . Cavities were restored and the specimens were fixed in intra-oral appliances and worn by 12 volunteers for 14 d. Sucrose solution was applied to each slab 6 times/d . Sample s were removed , sectioned , and examined for microhardness at 100 , 200 , and 300 microm ( factor distance ) , and 30 , 60 , and 90 microm ( factor depth ) , from the restoration and enamel surface , respectively . RESULTS Analysis of variance according to a split-plot model showed no difference among the cavity preparation techniques , among distances , or among depths , as well as no difference in the interaction between the factors of cavity preparation and distance . A significant difference was found in the interaction of cavity preparation and depth ( p < 0.0001 ) , as identified by contrast technique . CONCLUSION The results revealed that the Er : YAG laser did not differ from conventional cavity preparation with regard to enamel microhardness AIM This in situ study assessed the effects of adhesive systems containing or not fluoride and /or the antibacterial monomer 12-methacryloyloxydodecylpyridinium bromide ( MDPB ) on the microbiological composition of dental biofilm and enamel demineralization . MATERIAL S AND METHODS During two phases of 14 days , ten volunteers wore intraoral palatal appliances containing two slabs of human enamel according to a double-blind , crossover design . The slabs were r and omly restored using a composite resin and one of the following adhesive systems : All-Bond SE(TM ) ( self-etch , fluoride/MDPB free adhesive , AB ) and Clearfl Protect Bond ( self-etch containing fluoride and MDPB adhesive , CB ) . The biofilm formed on the slabs was analyzed with regard to total and mutans streptococci and lactobacilli counts . Demineralization represented by integrated area of hardness × lesion depth Delta S ( ΔS ) was determined on enamel by analysis of cross-sectional microhardness , at 20 and 70 μm from the restoration margin . Data were analyzed by ANOVA . RESULTS No statistically significant difference was found either in enamel demineralization or in the microbiological composition of dental biofilm . CONCLUSION All adhesive systems containing or not fluoride and /or MDPB tested were unable to inhibit secondary caries in the in situ model used in the present research OBJECTIVES Since secondary caries is one of the main reasons for replacing restorations , this study assessed the effects of different restorative material s on the microbiological composition of dental biofilm and on enamel demineralisation around the restoration . METHODS A r and omized , double-blind , split-mouth in situ design was conducted in one phase of 14 days , during which , 20 volunteers wore palatal devices containing five human dental enamel slabs . Each slab was r and omly restored with one of the following material s : Filtek-Z-250/Single Bond , control group ( composite resin ) , Permite ( amalgam ) , Fuji II ( encapsulated resin-modified glass ionomer ) , Vitremer ( resin-modified glass ionomer ) and Ketac Molar ( conventional glass ionomer ) . The volunteers used fluoride dentifrice , 3x/day and a 20 % sucrose solution was dripped onto the slabs 8x/day . The biofilm formed on the slabs was analyzed to determine the counts of total streptococci , mutans streptococci and lactobacilli . Enamel demineralisation was determined by cross-sectional microhardness
Output:
| Discussion : Studies conducted with palatal models showed caries progression rates 2–5 times higher than the estimated clinical progression rates . |
MS212416 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The actual effectiveness rates of natural and barrier methods of family planning are lower than the theoretical ones . If couples accurately defined the limits of the fertile phase and used barriers at that time , then actual effectiveness might increase . A r and omized , controlled clinical trial was initiated to determine the effectiveness of the contraceptive sponge used only during the fertile time and to compare this with sponge use at every intercourse . Recruitment problems and discontinuation forced the early termination of this study , but qualitative information about compliance and acceptability was collected . Common sponge problems were reported as were misuses of the sponge , but problems and misuse were not related . Determination of the fertile phase was reportedly easy , but complaints of and discontinuation for inconvenience occurred . For unplanned pregnancies , contraceptive behaviors around the time of conception are presented The results of a r and omized United States study indicated that the Today contraceptive sponge was less effective than the diaphragm ( 1-year cumulative life-table rate of 17.4 versus 12.9 pregnancies per 100 women , p = 0.01 ) . However , this overall comparison is misleading . Using univariate and multivariate analyses to account for the effects of user characteristics we found parity to be the most important single determinant of effectiveness for users of the sponge , but parity was unimportant as a risk factor for pregnancy among diaphragm users . For nulliparous women the sponge was as effective as a physician-prescribed barrier method ( 13.9 for sponge , 12.8 for diaphragm , p = 0.45 ) ; however , parous women using the sponge were twice as likely to become pregnant ( 28.3 for sponge , 13.4 for diaphragm , p = 0.001 ) . The effect of parity among sponge users is consistent with the results of international studies of the contraceptive sponge Proper r and omisation means little if investigators can not include all r and omised participants in the primary analysis . Participants might ignore follow-up , leave town , or take aspartame when instructed to take aspirin . Exclusions before r and omisation do not bias the treatment comparison , but they can hurt generalisability . Eligibility criteria for a trial should be clear , specific , and applied before r and omisation . Readers should assess whether any of the criteria make the trial sample atypical or unrepresentative of the people in which they are interested . In principle , assessment of exclusions after r and omisation is simple : none are allowed . For the primary analysis , all participants enrolled should be included and analysed as part of the original group assigned ( an intent-to-treat analysis ) . In reality , however , losses frequently occur . Investigators should , therefore , commit adequate re sources to develop and implement procedures to maximise retention of participants . Moreover , research ers should provide clear , explicit information on the progress of all r and omised participants through the trial by use of , for instance , a trial profile . Investigators can also do secondary analyses on , for instance , per- protocol or as-treated participants . Such analyses should be described as secondary and non-r and omised comparisons . Mish and ling of exclusions causes serious method ological difficulties . Unfortunately , some explanations for mish and ling exclusions intuitively appeal to readers , disguising the seriousness of the issues . Creative mismanagement of exclusions can undermine trial validity To investigate the effect of the contraceptive sponge on the incidence of sexually transmitted diseases , we conducted a clinical trial among a high-risk population of women in Bangkok , Thail and . Two hundred fifty-five women were r and omly assigned either to use the sponge or not and were evaluated weekly for gonorrhea and chlamydial infection . After adjustment by logistic regression for potentially confounding factors , women using the sponge were less likely to have contracted chlamydial infection ( odds ratio [ OR ] , 0.6 ; 90 % confidence interval [ CI ] , 0.4 - 1.0 ) and gonorrhea ( OR , 0.9 ; CI , 0.6 - 1.3 ) as compared with women not using the sponge . These estimates probably underestimate the degree of protection because some exposure was misclassified in this pilot phase of the study . These results are consistent with other studies indicating that spermicides protect against gonorrhea and also demonstrating protection against an organism of even greater public health concern , Chlamydia trachomatis Objective : This study was undertaken to assess the efficacy , safety and acceptability of two different-dose regimens of the Protectaid ® contraceptive sponge . Methods : The toxic effects of two forms of the new vaginal contraceptive sponge , Protectaid ® , in the cervical and vaginal tissues were studied . Both types were impregnated with F-5 gel containing different doses of nonoxynol-9 ( NX9 ; 0.5 % and 0.125 % ) . The sponge was used by 35 women aged 20 - 35 years ( mean 28.7 years ) r and omly allocated into two groups ( Group A : 0.5 % NX9 , n = 20 ; Group B : 0.125 % NX9 , n = 15 ) . Results : During a 12-month period both regimens demonstrated a 91.4 % overall contraceptive efficacy . Colposcopic examinations showed no significant cervical or vaginal lesions in either group , except for two cases at the 2-week and 3-month examinations in Group A women . In the former , inflammatory changes of little clinical significance were seen and the colposcopic appearance of the vagina was non-specific . In this case , the focal lesions were accompanied by dilated capillaries ( hyperemia ) . In the second case , degenerative inflammatory changes , with the inflammatory foci varying in shape and distribution , were observed . Cervical cultures taken 6 months after the start of treatment showed the presence of Mycoplasma hominis and C and ida albicans in one and two cases , respectively , in Group A. In Group B , cervical cultures taken at 3 months showed Gardnerella vaginalis and β-hemolytic streptococci group B in one and two cases , respectively . Conclusion : The potent spermicidal and protective properties of this new contraceptive sponge may be of benefit to the sexually active female . Since the sponge was very well accepted by both the study participants and their sexual partners , it can be considered as a valuable barrier method A comparative trial was conducted in the United States to compare the Today contraceptive sponge and the diaphragm used with spermicide . Subjects were r and omly assigned to contraceptive methods and were followed up for 1 year . None of the subjects were previous sponge users , but about 30 % were previous diaphragm users . The overall cumulative 1-year life-table pregnancy rate was higher for sponge users compared to diaphragm users . No serious side effects occurred with either product . The discontinuation rates for allergic-type reactions and discomfort were higher for sponge users . Similar rates of method -related complaints and discontinuation rates for personal and product-related reasons suggest there were no differences in the acceptability of the two products . In this trial , the allowable use time for the sponge was 2 days . The sponge is now recommended for 1-day use . The overall results of the study indicate the sponge to be a safe and acceptable method of contraception with an effectiveness rate in the range of that for other vaginal contraceptives Users of the Today contraceptive sponge who participated in a comparative trial of the sponge and diaphragm were followed up for an additional year . There were no serious adverse effects attributable to sponge use during the second year of use . The second year life-table pregnancy rate for sponge users was significantly lower ( p<0.05 ) than the first year rate . The pregnancy rates for first time sponge and diaphragm users were similar ( p>0.10 ) and both rates improved with increasing user experience . ResuméLes utilisatrices d'éponges contraceptives Today qui ont participé à des essais destinés à faire une comparaison entre les éponges et les diaphragmes ont été suivies pendant une année supplémentaire . Aucun effet défavorable grave qui puisse être attribué à l'usage des éponges n'a été constaté au cours de la seconde année . Les taux de grossesses chez les utilisatrices d'éponges ont été significativement plus faibles ( p<0,05 ) pour la seconde année que pour la première ( calculé par la méthode des tables de survie ) . Les taux de grossesses étaient similaires chez celles qui utilisaient l'éponge et le diaphragme pour la première fois ( p>0,10 ) et ces taux se sont améliorés dans un cas comme dans l'autre à mesure que ces femmes en acquéraient l'expérience . ResumenA usuarias de la esponja anticonceptiva Today que participaron en una prueba comparativa de la esponja y el diafragma , se les hizo seguimiento durante un año adicional . Durante el segundo año de uso no se produjeron effectos adversos serios atribuibles a la esponja . Los embarazos que ocurrieron durante el segundo año de uso , analizados por la tabla de vida , fueron significativamente más bajos que los del primer año ( p<0.05 ) . Las tasas de embarazo para usuarias por primera vez de la esponja y del diafragma fueron similares ( p>0,10 ) y ambas tasas mejoraron con el aumento de experiencia en las usuarias This paper describes the results from a r and omized clinical trial comparing the Collatex vaginal contraceptive sponge ( a predecessor of the Today sponge ) and Neo Sampoon foaming vaginal contraceptive tablets ; the trial was conducted from 1979 to 1983 in four centers located in three countries ( two in Yugoslavia and one each in Taiwan and Bangladesh ) . The sponge was associated with more insertion and retention problems than the tablet , especially in the two Asian centers . More Neo Sampoon users complained of a burning or stinging sensation . This complaint , however , seemed to be well-tolerated and was not a frequent reason for irregular use and /or discontinuation of use of the tablets . Clinical ly significant medical complications were rarely reported for either method . Sponge users were more likely to report irregular use than tablet users , primarily due to inconvenience of use . Rates of discontinuation at six months of use were also consistently higher among sponge users than Neo Sampoon users in the four centers . Life-table pregnancy rates at 12 months of use ranged from 3.8 to 18.2 per 100 sponge users and 6.2 to 29.9 per 100 Neo Sampoon users , based on data from the two Yugoslavian centers and the Taiwan center ( data from the Bangladesh center were excluded from analysis of pregnancy rates ) . Practical implication s of these findings are discussed Neo Sampoon , a foaming vaginal tablet containing 60 mg of the spermicide menfegol , and the Collatex sponge ( now marketed in the United States as the Today sponge ) , a domeshaped polyurethane device that contains 1 g of nonoxynol-9 , were compared in terms of effectiveness , safety , and acceptability . Both methods were new to the Maribor General Hospital , Yugoslavia , where the trial was conducted among 450 volunteers r and omly assigned to one of the two methods . At 12 months , the life-table pregnancy rate per 100 women for the Neo Sampoon group was 12.8 , compared with a rate of 10.4 among the sponge users ( P>.10 ) . After pregnancy , the second most frequent reason for termination was discomfort , with a 12-month termination rate due to this cause of 6.9 per 100 women in the Neo Sampoon group and 6.2 in the sponge group . Although fewer than a quarter of the volunteers had any experience with barrier methods before this trial , the life-table continuation rate was high in both groups , with more than 70 % using their assigned method for the full 12 months . Also , upon conclusion of the study , 41 % of the volunteers chose another barrier contraceptive method . Although the effectiveness of the sponge and Neo Sampoon is not comparable to that of the pill or IUD , both vaginal methods appear to be safe and acceptable additions to the range of contraceptive choices To investigate the effect of the nonoxynol 9-impregnated contraceptive sponge on the incidence of chlamydial infection , gonorrhea , and c and idiasis , we conducted a r and omized comparative study among high-risk women in Bangkok , Thail and . The first ( parallel ) portion of the study covered 434 woman-weeks among sponge users and 494 woman-weeks among nonusers . As compared with women not using the sponge , sponge users were found to be less likely to become infected with chlamydia ( relative rate , 0.67 ; 95 % confidence interval , 0.42 to 1.07 ) and gonorrhea ( relative rate , 0.31 [ 0.16 to 0.60 ] ) but more likely to become infected with C and ida ( relative rate , 2.76 [ 0.96 to 7.98 ] ) . Women who continued in the study were crossed over to the alternate group , with former nonusers starting to employ the sponge and vice versa . The results of this second phase were similar to those of the larger parallel study . Overall , these results suggest that women using the sponge are protected against the two most common sexually transmitted pathogens , which are also those with the most serious health consequences . However , women using the sponge should be advised they may have an increased likelihood of a vaginal infection with C and ida CONTEXT Nonoxynol-9 has been suggested as a vaginal microbicide to protect against common sexually transmitted infections . O
Output:
| REVIEW ER 'S CONCLUSIONS The sponge was less effective than the diaphragm in preventing pregnancy .
Discontinuation rates were higher at 12 months as well . |
MS212417 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: BACKGROUND Infants born very preterm ( <33 weeks ) are at increased risk of neurocognitive deficits . Their neurodevelopmental outcome up to age 8 years can be predicted by neonatal ultrasonography , but little is known of their later function . We investigated the effect of very preterm birth on brain structure and neurocognitive and behavioural functioning in adolescence . METHODS A cohort of 105 infants born before 33 weeks of gestation in 1979 - 80 had ultrasonographic scans at University College Hospital , London , and were prospect ively examined at 1 , 4 , and 8 years . At age 14 - 15 years , 72 of those who remained in UK ( cases ) and 21 age-matched full-term controls underwent brain magnetic resonance imaging ( MRI ) , as well as neurological , cognitive , and behavioural assessment . MRI images were assessed by two neuroradiologists unaware of ultrasonographic findings or case or control status . FINDINGS Of the 72 cases , 40 had unequivocally abnormal MRI and 15 had equivocal scans . Of the 21 controls , one had abnormal and five equivocal MRI . Abnormalities of ventricles , corpus callosum , and white matter were especially common in cases . More brain lesions were identified by MRI than by neonatal ultrasonography . The cases had significantly more reading , adjustment , and neurological impairments than controls , but their behaviour was significantly related to MRI abnormality . INTERPRETATION Individuals born very preterm show an excess of neurocognitive and behavioural problems in adolescence , and more than half have abnormal MRI brain scans OBJECTIVE To assess whether cervical cerclage in women deemed to be at increased risk of cervical incompetence prolongs pregnancy and thereby improves fetal and neonatal outcome . DESIGN Multicentre r and omised controlled trial . SETTING Hospitals in the United Kingdom , France , Hungary , Norway , Italy , Belgium , Zimbabwe , South Africa , Icel and , Irel and , the Netherl and s and Canada . SUBJECTS One thous and two hundred and ninety-two pregnant women whose obstetricians were uncertain whether to recommend cervical cerclage , most of whom had a history of early delivery or cervical surgery . INTERVENTIONS Cervical cerclage was compared with a policy of withholding the operation unless it was considered to be clearly indicated . MAIN OUTCOME MEASURES Delivery before 33 completed weeks , preterm delivery ( < 37 weeks ) , and vital status of the baby after completion of the pregnancy . RESULTS The overall preterm delivery rate was 28 % . There were fewer deliveries before 33 weeks in the cerclage group ( 83 ( 13 % ) compared with 110 ( 17 % ) , P = 0.03 ) and this difference reflected deliveries characterised by features of cervical incompetence ( painless cervical dilatation and prelabour rupture of the membranes ) . There was a corresponding difference in very low birthweight deliveries ( 63 ( 10 % ) compared with 86 ( 13 % ) , P = 0.05 ) . The difference in the overall rate of miscarriage , stillbirth or neonatal death ( 55 ( 9 % ) compared with 68 ( 11 % ) ) was less marked and was not statistically significant . The use of cervical cerclage was associated with increased medical intervention and a doubling of the risk of puerperal pyrexia . CONCLUSIONS These results suggest that the operation had an important beneficial effect in 1 in 25 cases in the trial ( 95 % confidence interval ( CI ) 1 in 12 to 1 in 300 sutures ) . Its use is associated with increased medical intervention and puerperal pyrexia . Nevertheless , this trial suggests that , on balance , cervical cerclage should be offered to women at high risk , such as those with a history of three or more pregnancies ending before 37 weeks gestation Objective : The aim of the present study was to compare the outcome of pregnancies among patients with suspected cervical incompetence treated either by elective cervical cerclage or an alternative management program involving cervical surveillance To determine the value of transvaginal sonography in women with a previous history of second trimester miscarriage due to cervical incompetence , 55 patients were subjected to either elective cervical cerclage or follow-up ( every second patient ) with weekly evaluations of the cervix by transvaginal ultrasonography . Emergency cerclage was applied when significant cervical changes were noted . All patients were evaluated with cervical cultures and ultrasound . Women with infection , fibroids , uterine malformations and multiple pregnancies were excluded from the study . The study population was divided in two groups . In group I ( n=27 ) elective cerclage was applied during the 14th week . Women in group II ( n=28 ) were subjected to serial weekly evaluations of the cervix by transvaginal ultrasonograms . In 18 cases emergency cerclage was applied due to significant cervical changes . In group I , labor started before the 33rd week in two cases ( 7.4 % ) , between 33 and 37 weeks in nine ( 33.3 % ) and after the 37th week in 16 cases ( 59.2 % ) . Out of the 18 patients in group II who had cervical cerclage after ultrasonographic evaluation , four ( 22.2 % ) delivered before the 33rd week , three ( 16.6 % ) between 33 and 37 weeks and 11 ( 61.1 % ) after the 37th week . No statistical difference was noted between the two groups referring to pregnancy outcome ( p<0.1 ) . We concluded that ultrasound-guided management despite cervical shortening , does not result in unfavorable pregnancy outcome . A significant number of patients can avoid the operation OBJECTIVE The objective of this study was to compare different management strategies for women at risk for cervical incompetence . STUDY DESIGN In an ongoing r and omized trial patients with a previous preterm delivery at < 34 weeks ' gestation who met clinical criteria for the diagnosis of cervical incompetence are allocated to receive a prophylactic cerclage ( prophylactic cerclage group ) or not ( observational group ) in a proportion of 1:2 . Transvaginal ultrasonographic follow-up examination of the cervix is performed in both groups . When a patient of the latter group has a cervical length < 25 mm at < 27 weeks ' gestation , a further r and om assignment of therapeutic cerclage or no cerclage is performed . The analysis is by intent to treat . RESULTS Primary r and om assignment allocated 23 women to the prophylactic cerclage group and 44 to the observational group . Both groups were comparable with respect to obstetric history . No significant difference was found between the prophylactic cerclage group and the observational group in preterm delivery at < 34 weeks ' gestation ( 3/23 vs 6/44 , respectively ) and neonatal survival ( 21/23 vs 41/44 , respectively ) . A cervical length < 25 mm was found in 18 patients ( 41 % ) in the observational group at a mean gestational age of 19.1 + /- 2.9 weeks ' gestation . Incidence of preterm delivery at < 34 weeks ' gestation was significantly higher in the group with short cervical length ( 6/18 vs 0/26 ; P = .003 ) . Secondary r and om assignment of the 18 patients with short cervical length allocated 10 to undergo therapeutic cerclage . Preterm delivery at < 34 weeks ' gestation was significantly less frequent in the therapeutic cerclage group ( 1/10 vs 5/8 ) . CONCLUSION Transvaginal ultrasonographic serial follow-up examinations of the cervix in women at risk for cervical incompetence , with secondary intervention as indicated , appears to be a safe alternative to the traditional prophylactic cerclage . Transvaginal ultrasonographic follow-up examination of the cervix can save the majority of women from unnecessary intervention . Placement of a therapeutic cerclage may reduce the incidence of preterm delivery at < 34 weeks ' gestation among high-risk patients BACKGROUND The role of the cervix in the pathogenesis of premature delivery is controversial . In a prospect i ve , multicenter study of pregnant women , we used vaginal ultrasonography to measure the length of the cervix ; we also documented the incidence of spontaneous delivery before 35 weeks ' gestation . METHODS At 10 university-affiliated prenatal clinics , we performed vaginal ultrasonography at approximately 24 and 28 weeks of gestation in women with singleton pregnancies . We then assessed the relation between the length of the cervix and the risk of spontaneous preterm delivery . RESULTS We examined 2915 women at approximately 24 weeks of gestation and 2531 of these women again at approximately 28 weeks . Spontaneous preterm delivery ( at less than 35 weeks ) occurred in 126 of the women ( 4.3 percent ) examined at 24 weeks . The length of the cervix was normally distributed at 24 and 28 weeks ( mean [ + /- SD ] , 35.2 + /- 8.3 mm and 33.7 + /- 8.5 mm , respectively ) . The relative risk of preterm delivery increased as the length of the cervix decreased . When women with shorter cervixes at 24 weeks were compared with women with values above the 75th percentile , the relative risks of preterm delivery among the women with shorter cervixes were as follows : 1.98 for cervical lengths at or below the 75th percentile ( 40 mm ) , 2.35 for lengths at or below the 50th percentile ( 35 mm ) , 3.79 for lengths at or below the 25th percentile ( 30 mm ) , 6.19 for lengths at or below the 10th percentile ( 26 mm ) , 9.49 for lengths at or below the 5th percentile ( 22 mm ) , and 13.99 for lengths at or below the 1st percentile ( 13 mm ) ( P < 0.001 for values at or below the 50th percentile ; P = 0.008 for values at or below the 75th percentile ) . For the lengths measured at 28 weeks , the corresponding relative risks were 2.80 , 3.52 , 5.39 , 9.57 , 13.88 , and 24.94 ( P < 0.001 for values at or below the 50th percentile ; P = 0.003 for values at the 75th percentile ) . CONCLUSIONS The risk of spontaneous preterm delivery is increased in women who are found to have a short cervix by vaginal ultrasonography during pregnancy OBJECTIVE To compare pregnancy outcome for women at risk of preterm delivery undergoing elective cervical cerclage in the first trimester or serial transvaginal assessment of cervical length with cerclage only if indicated ( control cases ) . DESIGN A matched case control study . SETTING Prematurity clinic at two London teaching hospitals . POPULATION Women at high risk for preterm delivery . METHODS Cases of elective cervical cerclage were matched for maternal age , ethnic group , previous cervical surgery , previous second trimester loss and early preterm delivery to women undergoing serial ultrasound surveillance of cervical length . Pregnancy outcome data was collected . Data was analysed using Fisher 's exact , Mann-Whitney and Student 's t-tests . MAIN OUTCOME MEASURES Gestation at delivery , rate of delivery < 24 , 24 - 32 and 32 - 37 weeks gestation . RESULTS Thirty-nine cases of elective cervical cerclage were matched to control cases . Both groups were similar for maternal age , ethnic group , previous cervical surgery , previous second trimester loss and early preterm delivery . Cervical cerclage was performed in 14 ( 36 % ) of the control cases due to cervical changes . There was no significant difference in median gestation at delivery ( 266 days versus 260 days P=0.9 ) , number delivering < 24 weeks ( 15 % versus 13 % P=0.9 ) , at 24 - 32 weeks ( 7.5 % versus 15 % P=0.6 ) and at 32 - 37 weeks ( 15 % versus 13 % P=0.9 ) . CONCLUSION Serial transvaginal ultrasound surveillance of cervical length in women at high risk of preterm delivery appears to reduce cerclage rates without compromising pregnancy outcome . A large multicentered r and omised trial is required to confirm these findings Summary . A total of 506 women at moderate risk of preterm delivery were r and omly allocated to either cervical cerclage or a control group . Significantly more women in the group allocated to cerclage were admitted to hospital for reasons other than the operation and more received oral toco‐lytic drugs . There were also more caesarean sections and more preterm deliveries in the women allocated to cerclage although the differences between the two groups were small and not statistically significant
Output:
| In conclusion , using ultrasound to identify women at risk of cervical insufficiency because of a history of PTD reduces cerclage rates and results in similar pregnancy outcomes as cerclage placement on the basis of history alone . |
MS212418 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Objective To determine the attributable cost of ventilator-associated pneumonia from a hospital-based cost perspective , after adjusting for potential confounders . Design Patients admitted between January 19 , 1998 , and December 31 , 1999 , were followed prospect ively for the occurrence of ventilator-associated pneumonia . Hospital costs were defined by using the hospital cost accounting data base . Setting The medical and surgical intensive care units at a suburban , tertiary care hospital . Patients Patients requiring > 24 hrs of mechanical ventilation . Interventions None . Measurements and Main Results We measured occurrence of ventilator-associated pneumonia , in-hospital mortality rate , total intensive care unit ( ICU ) and hospital lengths of stay ( LOS ) , and total hospital cost per patient . Ventilator-associated pneumonia occurred in 127 of 819 patients ( 15.5 % ) . Compared with uninfected , ventilated patients , patients with ventilator-associated pneumonia had a higher Acute Physiology and Chronic Health Evaluation II score on admission ( p < .001 ) and were more likely to require multiple intubations ( p < .001 ) , hemodialysis ( p < .001 ) , tracheostomy ( p < .001 ) , central venous catheters ( p < .001 ) , and corticosteroids ( p < .001 ) . Patients with ventilator-associated pneumonia were more likely to be bacteremic during their ICU stay ( 36 [ 28 % ] vs. 22 [3%];p < .001 ) . Patients with ventilator-associated pneumonia had significantly higher unadjusted ICU LOS ( 26 vs. 4 days;p < .001 ) , hospital LOS ( 38 vs. 13 days;p < .001 ) , mortality rate ( 64 [ 50 % ] vs. 237 [34%];p < .001 ) , and hospital costs ( $ 70,568 vs. $ 21,620 , p < .001 ) . Multiple linear regression , controlling for other factors that may affect costs , estimated the attributable cost of ventilator-associated pneumonia to be $ 11,897 ( 95 % confidence interval = $ 5,265–$26,214;p < .001 ) . Conclusions Patients with ventilator-associated pneumonia had significantly longer ICU and hospital LOS , with higher crude hospital cost and mortality rate compared with uninfected patients . After we adjusted for underlying severity of illness , the attributable cost of ventilator-associated pneumonia was approximately $ 11,897 Objective : To determine whether use of a single heat and moisture exchanger ( HME ) for ≤120 hrs affects efficiency , resistance , level of bacterial colonization , frequency rate of nosocomial pneumonia , and cost compared with changing the HME every 24 hrs . Design : Prospect i ve , controlled , r and omized , unblinded study . Setting : Surgical intensive care unit at a university teaching hospital . Patients : A total of 220 consecutive patients requiring mechanical ventilation for > 48 hrs . Interventions : Patients were r and omized to one of three groups : a ) hygroscopic HME ( Aqua+ ) changed every 24 hrs ( HHME‐24 ) ; b ) hydrophobic HME ( Duration HME ) changed every 120 hrs ( HME‐120 ) ; and c ) hygroscopic HME ( Aqua+ ) changed every 120 hrs ( HHME‐120 ) . Devices in all groups could be changed at the discretion of the staff when signs of occlusion or increased resistance were identified . Measurements and Main Results : Daily measurements of inspired gas temperature , inspired relative humidity , and device resistance were made . Additionally , daily cultures of the patient side of the device were accomplished . The frequency rate of nosocomial pneumonia was made by using clinical criteria . Ventilatory support variables , airway care , device costs , and clinical indicators of humidification efficiency ( sputum volume , sputum efficiency ) were also recorded . Prolonged use of both hygroscopic and hydrophobic devices did not diminish efficiency or increase resistance . There was no difference in the number of colony‐forming units from device cultures over the 5‐day period and no difference between colony‐forming units in devices changed every 24 hrs compared with devices changed after 120 hrs . The average duration of use was 23 ± 4 hrs in the HHME‐24 group , 73 ± 13 hrs in the HME‐120 group , and 74 ± 9 hrs in the HHME‐120 group . Mean absolute humidity was greater for the hygroscopic devices ( 30.4 ± 1.1 mg of H2O/L ) compared with the hydrophobic devices ( 27.8 ± 1.3 mg of H2O/L ) . The frequency rate of nosocomial pneumonia was 8 % ( 8:100 ) in the HHME‐24 group , 8.3 % ( 5:60 ) in the HME‐120 group , and 6.6 % ( 4:60 ) in the HHME‐120 group . Pneumonia rates per 1000 ventilatory support days were 20:1000 in the HHME‐24 group , 20.8:1000 in the HME‐120 group , and 16.6:1000 in the HHME‐120 group . Costs per day were $ 3.24 for the HHME‐24 group , $ 2.98 for the HME‐120 group , and $ 1.65 for the HHME‐120 group . Conclusions : Changing the hydrophobic or hygroscopic HME after 3 days does not diminish efficiency , increase resistance , or alter bacterial colonization . The frequency rate of nosocomial pneumonia was also unchanged . Use of HMEs for > 24 hrs , up to 72 hrs , is safe and cost effective Objective : To document the effect of gingival and dental plaque antiseptic decontamination on the rate of nosocomial bacteremias and respiratory infections acquired in the intensive care unit ( ICU ) . Design : Prospect i ve , multicenter , double-blind , placebo-controlled efficacy study . Setting : Six ICUs : three in university hospitals and three in general hospitals . Patients : A total of 228 nonedentulous patients requiring endotracheal intubation and mechanical ventilation , with an anticipated length of stay ≥5 days . Interventions : Antiseptic decontamination of gingival and dental plaque with a 0.2 % chlorhexidine gel or a placebo gel , three times a day , during the entire ICU stay . Measurements and Main Results : Demographic and clinical characteristics , organ function data ( Logistic Organ Dysfunction score ) , severity of condition ( Simplified Acute Physiologic Score ) , and dental plaque status were assessed at baseline and until 28 days . Bacteriologic sampling of dental plaque and saliva was done every 5 days , and blood , tracheal aspirate , and bronchoalveolar lavage cultures were performed when appropriate . The primary efficacy end point was the incidence of bacteremia , bronchitis , and ventilator-associated pneumonia , expressed as a percentage and per 1000 ICU days . All baseline characteristics were similar between the treated and the placebo groups . The incidence of nosocomial infections was 17.5 % ( 13.2 per 1000 ICU days ) in the placebo group and 18.4 % ( 13.3 per 1000 ICU days ) in the plaque antiseptic decontamination group ( not significant ) . No difference was observed in the incidence of ventilator-associated pneumonia per ventilator or intubation days , mortality , length of stay , and care loads ( secondary end points ) . On day 10 , the number of positive dental plaque cultures was significantly lower in the treated group ( 29 % vs. 66 % ; p < .05 ) . Highly resistant Pseudomonas , Acinetobacter , and Enterobacter species identified in late-onset ventilator-associated pneumonia and previously cultured from dental plaque were not eradicated by the antiseptic decontamination . No side effect was reported . Conclusions : Gingival and dental plaque antiseptic decontamination significantly decreased the oropharyngeal colonization by aerobic pathogens in ventilated patients . However , its efficacy was insufficient to reduce the incidence of respiratory infections due to multiresistant bacteria BACKGROUND The purpose of this study was to compare the performance of heat and moisture exchanger filters with heated humidifying systems in the mechanical ventilator circuit on the incidence of ventilator-associated pneumonia ( VAP ) and bacterial colonization . METHOD Two hundred and forty-three consecutive patients who required mechanical ventilation for 48 hours or more in the adult intensive care unit were r and omized to either a heat and moisture exchanger ( HME ) or a heated humidifying breathing circuit . RESULTS The VAP rate among the group with HME was 11.4 % ; the rate among the group with heated humidifying system ( HHS ) was 15.8 % . The difference was not statistically significant . Approximately 68 % of the patients in the HME group had no pathogen isolated compared with 50 % of the patients in the HHS group . This difference was statistically significant ( P = .006 ) . However , the distribution of the pathogens among those patients who had the isolated pathogens was mostly identical in the 2 groups . CONCLUSION Even though the study did not find HME to be significantly advantageous over the HHS , in as much as VAP rate is concerned , other advantages such as reduced nurses workload , reduced financial cost , and better safety made HME a more favorable device for use in our adult intensive care unit This a r and omized clinical trial in which 20 patients were prospect ively evaluated for the incidence of ventilator-associated pneumonia ( VAP ) , of whom 12 received endotracheal suctioning by an open-suction method and 8 by a closed-suction method . Differences in the incidence of VAP was not significantly different ( p = 0.4 ) between closed and open suctioning . Differences in Acute Physiology and Chronic Health Evaluation II , duration of entubation , and the use of steroids were all not significant . All patients in the study used H2 antagonist and a nasogastric tube . Proceeding with the study will involve a sample increase with a possible change in the results Nosocomial pneumonia is the leading cause of death among all hospital-acquired infections [ 1 ] . The estimated incidence of nosocomial pneumonia in intensive care units ranges from 10 % to 65 % ; most studies [ 2 - 6 ] show case fatality rates of more than 20 % . Ventilator-associated pneumonia specifically refers to nosocomial pneumonia that develops in a mechanically ventilated patient and that was not present at the time of airway intubation [ 7 ] . Various clinical risk factors have been associated with an increased incidence of ventilator-associated pneumonia , either because they predispose the patient to bacterial colonization of the oropharynx and stomach ( for example , the administration of antacids or histamine-2-receptor antagonists ) or because they facilitate aspiration of contaminated contents from these sites ( for example , supine positioning ) [ 1 , 2 , 8 , 9 ] . Craven and colleagues [ 10 ] first showed that the frequency of ventilator circuit changes also influences the incidence of ventilator-associated pneumonia . They found that changing circuits every 24 rather than every 48 hours was independently associated with the occurrence of nosocomial pneumonia [ 10 ] . This association has been attributed to increased manipulation of the patient , the endotracheal tube , and the ventilator circuit , which results in increased aspiration of contaminated tubing condensate or upper airway secretions [ 10 , 11 ] . More recently , several groups of investigators have found that ventilator circuits can be used safely for more than 48 hours without increasing the incidence of nosocomial pneumonia [ 12 - 16 ] . However , because of limitations in the design of these studies and the small number of patients prospect ively examined , the Centers for Disease Control and Prevention has given no clear recommendation for the maximum length of time that ventilator circuits can safely be left in place during prolonged mechanical ventilation [ 17 ] . This has result ed in the development of ambiguous guidelines about the frequency with which ventilator circuits should be changed [ 18 , 19 ] and in a call for well- design ed investigations to resolve this issue [ 20 ] . We did a r and omized , controlled trial to compare the effect and cost-efficacy of routine and no routine ventilator circuit changes in patients having prolonged mechanical ventilation . Our main goals were to determine 1 ) the incidence and outcome of ventilator-associated pneumonia in patients receiving scheduled ventilator circuit changes and 2 ) whether this incidence was increased in patients whose ventilator circuits remained unchanged . Methods Study Location and Patients The study was conducted at two university-affiliated teaching hospitals : Barnes Hospital ( 900 beds ) and Jewish Hospital ( 450 beds ) . During a 7-month period ( June 1994 to December 1994 ) , all patients receiving mechanical ventilation in the intensive care units of these hospitals ( surgical , trauma , medical , cardiothoracic , and neurosurgical units at Barnes Hospital ; surgical , medical , and cardiothoracic units at Jewish Hospital ) were potentially eligible for this investigation . Patients were entered
Output:
| CONCLUSION There are a growing number of evidence -based strategies for VAP prevention , which , if applied in practice , may reduce the incidence of this serious nosocomial infection |
MS212419 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Functional outcome , stability at radiographic investigation and ankle joint torque after anatomical reconstruction of the lateral ankle ligaments were evaluated in patients with early postoperative mobilization versus those with cast immobilization . Thirty patients with chronic lateral ligament instability of the ankle underwent anatomical reconstruction of the ligaments . Postoperatively the patients were r and omly allocated to two groups : Group A ( n=15 ) were immobilized in a below-knee plaster for 6 weeks and Group B ( n=15 ) underwent early controlled range of motion training using an Air-Cast ankle brace . The functional results were evaluated using a scoring scale and objective results using st and ardized stress radiographs . Also eccentric and concentric muscle torque at 60 degrees/s was measured in plantar flexion and dorsiflexion , respectively . The functional results were satisfactory in 12/15 ankles in Group A and 14/15 in Group B ( n.s . ) . All the patients with satisfactory results regained normal range of motion . Patients with unsatisfactory results had either residual pain or recurrent instability . In Group B , the strength measurements revealed significantly higher peak torque values after three months in plantar flexion at 60 degrees/s . Six months postoperatively , the torque values did not differ significantly between the groups . Also , there was no group difference in the laxity of the ankle joint , including both anterior talar translation test and talar tilt test , at the two-year follow-up . One patient had a superficial wound infection . We conclude that after the reconstruction of chronic lateral ligament instability of the ankle the functional and stability results were equally good with early postoperative mobilization and 6-week immobilization . However , using early mobilization plantar flexion strength was regained earlier than with cast immobilization , without any risk of short- or medium-term complications , such as increased ankle laxity . We recommend early mobilization after anatomical reconstruction of the lateral ankle ligaments Sixty consecutive collegiate athletes with “ high ” ankle symptoms were prospect ively evaluated over a 3-year period in an effort to better define this debilitating ankle injury . All athletes included in this study had tenderness over the distal anterior tibiofibular ligament , tenderness proximally along the interosseous membrane , and functional disability . No study subject had a fracture or frank tibia-fibula diastasis . The severity of the sprain was quantified using the interosseous “ tenderness length . ” A st and ard rehabilitation protocol was followed by all patients . Athletes returned to competition when they could perform all functional testing without difficulty . Time to return to full competitive activity averaged 13.4 days . The number of days missed from competition was statistically related to the interosseous tenderness length ( P 0.0001 ) and to positive results on the squeeze test ( P 0.03 ) . Fifty-three of the 60 injured athletes were evaluated at least 6 months after injury . Patients rated their outcomes as good or excellent . Six of the patients experienced occasional ankle pain and stiffness , four patients reported recurrent ankle sprains , and one patient had heterotopic ossification formation STUDY DESIGN A nonr and omized 2-group pretest-posttest design . OBJECTIVES To determine the effects of a 4-week balance training program during stance on a single leg . BACKGROUND Individuals who have experienced multiple episodes of inversion ankle sprains often participate in balance training programs . Balance training is performed to treat existing proprioceptive deficits and to restore ankle joint stability , presumably by retraining altered afferent neuromuscular pathways . The effectiveness of such programs on individuals with functionally unstable ankles has yet to be established . METHODS AND MEASURES Prior to and following training , subjects with self-reported functionally unstable ankles ( 5 women and 8 men , mean age = 21.9 + /- 3.1 years ) and nonimpaired subjects ( 6 women and 7 men , mean age = 21.2 + /- 2.5 years ) completed a static balance assessment for both limbs as well as the ankle joint functional assessment tool question naire ( AJFAT ) . The subjects from both groups participated in a unilateral , multilevel , static and dynamic balance training program 3 times a week for 4 weeks . Subjects from the experimental group trained only the involved limb , and the nonimpaired group trained a r and omly selected limb . A stability index ( SI ) was calculated during the balance assessment to indicate the amount of platform motion . Compared to low stability indices , high stability indices indicate greater platform motion during stance and therefore less stability . RESULTS Following training , subjects from both groups demonstrated significant improvements in balance ability . When balance was assessed at a low resistance to platform tilt ( stability level 2 ) , the posttraining scores of both the subjects with unstable ankles ( mean SI = 2.63 + /- 1.92 ) and the nonimpaired subjects ( mean SI = 2.69 + /- 2.32 ) were significantly better than their pretraining scores ( mean SIs = 5.93 + /- 3.65 and 4.67 + /- 3.43 , respectively ) . Assessed at a high resistance to platform tilt ( stability level 6 ) , the posttraining scores of both subjects with unstable ankles ( mean SI = 1.27 + /- 0.66 ) and the nonimpaired subjects ( mean SI = 1.37 + /- 0.66 ) were significantly better than their pretraining scores ( mean SIs = 2.30 + /- 1.88 and 2.04 + /- 1.43 , respectively ) . Additionally , the posttraining AJFAT scores of subjects with unstable ankles ( 25.78 + /- 3.80 ) and the nonimpaired subjects ( 29.15 + /- 5.27 ) were significantly greater than their pretraining scores ( 17.11 + /- 3.44 and 22.92 + /- 5.22 , respectively ) , indicating an overall improvement in perceived ankle joint functional stability . CONCLUSIONS This study suggests that balance training is an effective means of improving joint proprioception and single-leg st and ing ability in subjects with unstable and nonimpaired ankles A bi-directional bicycle pedal that combines proprioceptive training and evertor strengthening has been developed for the treatment of residual instability after ankle sprains . A prospect i ve r and omized study was carried out on 19 subjects with recurrent ankle sprains and positive stress X-ray films . The subjects were r and omized to use either a bi-directional test pedal or a traditional uni-directional bicycle pedal and then completed a 6-week high-intensity training program on a cycle ergometer . Assessment of training intensity level was based on maximum oxygen uptake values , heart rate and lactate concentration in blood at various submaximal workloads . After completion of the training program , the subjects who had used the test pedal increased peak eversion torque at 180 degrees degrees s-1 by 14.2 % ( P = 0.020 ) , reduced figure-of-eight running time by 0.24 s ( P = 0.003 ) , improved single leg stance speed from 72.5 % to the maximum speed of 80 % ( P = 0.005 ) , and improved Karlsson functional score by 5.1 points ( P = 0.005 ) . In the control group , single leg stance improved from 56.1 to 67.8 % ( P = 0.018 ) , but otherwise no significant effects were found . This study indicates that short-term high-intensity training with a bi-directional pedal improves ankle performance and may be an option in the treatment of recurrent ankle sprains Objectives : To examine the effect of six weeks of strength and proprioception training on eversion to inversion isokinetic strength ratios ( E/I ratios ) in subjects with unilateral functional ankle instability . Methods : Thirty eight subjects were r and omly assigned to one of four treatment groups : strength training ( S ) ; proprioception training ( P ) ; strength + proprioception training ( B ) ; control ( C ) . Isokinetic strength was tested before and after training using a Kin Com 125 automatic positioning isokinetic dynamometer . Subtalar joint eversion and inversion motions were tested both concentrically and eccentrically through a range of motion involving 40 ° . All peak torque and average torque values were normalised for body mass . E/I ratios were calculated from average torque and peak torque measures by taking the concentric eversion value and combining it with the eccentric inversion value . Data were analysed using a mixed model analysis of variance with repeated measures on the test factor . Average torque and peak torque E/I ratios at 30 and 120 ° /s were analysed separately . Results : There were no significant differences in average torque and peak torque E/I ratios of the functionally unstable ankle for any of the groups after training compared with before . Conclusions : Six weeks of strength and proprioception training ( either alone or combined ) had no effect on isokinetic measures of strength in subjects with self reported unilateral functional instability . Further studies examining this agonist ( concentric ) to antagonist ( eccentric ) muscle group strength ratio are needed The purpose of this study was to examine a young athletic population to up date the data regarding epidemiology and disability associated with ankle injuries . At the United States Military Academy , all cadets presenting with ankle injuries during a 2-month period were included in this prospect i ve observational study . The initial evaluation included an extensive question naire , physical examination , and radiographs . Ankle sprain treatment included a supervised rehabilitation program . Subjects were reevaluated at 6 weeks and 6 months with subjective assessment , physical examination , and functional testing . The mean age for all subjects was 20 years ( range , 17–24 years ) . There were 104 ankle injuries accounting for 23 % of all injuries seen . There were 96 sprains , 7 fractures , and 1 contusion . Of the 96 sprains , 4 were predominately medial injuries , 76 were lateral , and 16 were syndesmosis sprains . Ninety-five percent had returned to sports activities by 6 weeks ; however , 55 % of these subjects reported loss of function or presence of intermittent pain , and 23 % had a decrement of > 20 % in the lateral hop test when compared with the uninjured side . At 6 months , all subjects had returned to full activity ; however , 40 % reported residual symptoms and 2.5 % had a decrement of > 20 % on the lateral hop test . Neither previous injury nor ligament laxity was predictive of chronic symptomatology . Furthermore , chronic dysfunction could not be predicted by the grade of sprain ( grade I vs. II ) . The factor most predictive of residual symptoms was a syndesmosis sprain , regardless of grade . Syndesmosis sprains were most prevalent in collision sports . This study demonstrates that even though our knowledge and underst and ing of ankle sprains and rehabilitation of these injuries have progressed in the last 20 years , chronic ankle dysfunction continues to be a prevalent problem . The early return to sports occurs after almost every ankle sprain ; however , dysfunction persists in 40 % of patients for as long as 6 months after injury . Syndesmosis sprains are more common than previously thought , and this confirms that syndesmosis sprains are associated with prolonged disability Exercises to improve joint proprioception and coordination of the functionally unstable ankle are advocated throughout the literature , yet there is little evidence that these exercise have any effect on proprioception and balance . The purpose of this study was to determine the effects of a 6-week coordination and balance training program on proprioception of subjects with functional ankle instability . Forty-five subjects ( age = 22.53 + /- 3.95 years , height = 172.04 + /- 10.0 cm , weight = 71.72 + /- 15.7 kg ) were r and omly placed into a control ( Group 1 ) , sham ( Group 2 ) , or experimental ( Group 3 ) group . The experimental group trained 3 days per week , 10 minutes each day , performing various balance and proprioception exercises . Postural sway and active and passive joint position sense were assessed . Analysis of variance for postural sway modified equilibrium score for anterior and posterior sway , as well as medial and lateral sway revealed significant four-way interactions . Tukey post hoc analyses revealed that Group 3 performed significantly better ( p < .05 ) than Group 1 and Group 2 on the posttests . There were no significant differences for joint position sense or postural sway index . Results suggest that balance and coordination training can improve some measures of postural sway . It is still unclear if joint position sense can be improved in the functionally unstable ankle OBJECTIVE To examine the effects of ankle-strengthening exercises on joint position sense and strength development in subjects with functionally unstable ankles . DESIGN AND SETTING Subjects were r and omly assigned to a training or control group . The training group participated in a 6-week strength-training protocol using rubber tubing 3 times a week throughout the training period . The control group did not participate in the strength-training protocol . SUBJECTS Twenty healthy college students ( 10 females , 10 males , age = 20.6 + /- 2.23 years ; ht = 176.40 + /- 7.14 cm ; wt = 74.18 + /- 10.17 kg ) with a history of functional ankle instability volunteered to participate in this study . MEASUREMENTS We pretested and posttested dorsiflexor and evertor isometric strength with a h and held dynamometer and collected joint position sense ( JPS ) data at 20 degrees for inversion and plantar
Output:
| Test-retest reliability was demonstrated for the FAOS , the FADI and the FAAM but not for the AJFAT .
For none of the studied instruments , the internal consistency was sufficiently demonstrated .
The presence of floor- and ceiling effects was assessed for the FAOS but ceiling effects were present for all subscales .
Responsiveness was demonstrated for the AJFAT , FADI and the FAAM .
Only for the FAAM , a minimal clinical important difference ( MCID ) was presented .
Conclusion The FADI and the FAAM can be considered as the most appropriate , patient-assessed tools to quantify functional disabilities in patients with chronic ankle instability . |
MS212420 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: All dementia patients and their caregivers who had received a University-based comprehensive evaluation and a diagnosis of Alzheimer 's disease during 1997 ( N = 80 ) were surveyed 1 year after their initial assessment . Of the original cohort , 72.5 % were contacted , and two subgroups were defined : 31 patients were being seen only by their primary care physicians ( MED ) , and 27 patients were being treated in addition by a geriatric psychiatry faculty member ( GERO ) . There were statistically significant differences between the two groups ( MED vs. GERO , respectively ) at follow-up in terms of : 1 ) hospitalization ( 39 % vs. 15 % ; P < O.05 ) ; 2 ) cognitive status ( P < O.05 ) ; and 3 ) prescription of donepezil at follow-up ( 35 % vs. 64 % ; P < O. 005 ) . These differences need to be assessed in a larger-scale prospect i ve study PURPOSE OF STUDY The authors determined short-term effects of a home environmental intervention on self-efficacy and upset in caregivers and daily function of dementia patients . They also determined if treatment effect varied by caregiver gender , race , and relationship to patient . DESIGN AND METHODS Families ( N = 171 ) of dementia patients were r and omized to intervention or usual care control group . The intervention involved 5 90-min home visits by occupational therapists who provided education and physical and social environmental modifications . RESULTS Compared with controls , intervention caregivers reported fewer declines in patients ' instrumental activities of daily living ( p = .030 ) and less decline in self-care and fewer behavior problems in patients at 3 months post-test . Also , intervention spouses reported reduced upset ( p = .049 ) , women reported enhanced self-efficacy in managing behaviors ( p = .038 ) , and women ( p = .049 ) and minorities ( p = .037 ) reported enhanced self-efficacy in managing functional dependency . IMPLICATION S The environmental program appears to have a modest effect on dementia patients ' IADL dependence . Also , among certain subgroups of caregivers the program improves self-efficacy and reduces upset in specific areas of caregiving STUDY QUESTION Did the Medicare Alzheimer 's Disease Demonstration , with its goal of improving caregiver outcomes through case management and subsidized community services , affect the nursing home entry rate of treatments with dementia compared to controls ? DATA SOURCES Interviews conducted at baseline and six months thereafter . Measures include date of nursing home entry , client and caregiver health , and income . STUDY DESIGN The demonstration r and omly assigned voluntary applicants into treatment and control groups . Treatment group cases were eligible for case management and for an 80 percent discount on community care benefits , up to about $ 600 per month . DATA COLLECTION All cases received baseline and semi-annual assessment interviews for up to three years after enrollment . Analyses are among cases that remained in the demonstration for more than 30 days after enrollment ( n = 8,095 ) . PRINCIPAL FINDINGS The intervention of case management and subsidized community service had no effect on nursing home entry rates for treatments overall , compared to those of controls , and few effects on treatment subgroups , with the exception of one site where it may have increased nursing home entry rates . CONCLUSIONS Providing case management and subsidized community services with the goal of improving caregiver outcomes may have little effect on nursing home entry rates for people with dementia The current study is a controlled clinical investigation of two nonpharmacological treatments of depression in patients with Alzheimer 's disease . Two active behavioral treatments , one emphasizing patient pleasant events and one emphasizing caregiver problem solving , were compared to an equal- duration typical care condition and a wait list control . Seventy-two patient-caregiver dyads were r and omly assigned to one of four conditions and assessed pre- , post- , and at 6-months follow-up . Patients in both behavioral treatment conditions showed significant improvement in depression symptoms and diagnosis as compared with the two other conditions . These gains were maintained at 6-month follow-up . Caregivers in each behavioral condition also showed significant improvement in their own depressive symptoms , while caregivers in the two other conditions did not . Results indicate that behavioral interventions for depression are important and effective strategies for treating demented patients and their caregivers OBJECTIVE --To reduce the psychological stress and improve the skills in coping of people who care for relatives with dementia . DESIGN -- Assessment and suitability of carers by question naire ; assessment of patients and carers in a hospital outpatient clinic ; allocation to groups according to date of application to study . Linkage of groups of four carers and programme coordinator by telephone conference calls over 12 months after programmes . Re assessment at three , six , 12 , and , for those in the " wait list " group , 18 months . SETTING --The programmes were conducted in the psychiatry unit of a Sydney teaching hospital . SUBJECTS -- Eligible patients were less than 80 years old , had mild to moderate dementia , and lived at home with their carer . Of the 96 patient-carer pairs in the study , 33 were in the dementia carers ' programme group , 31 were in the memory retraining group , and 32 were in the wait list group . INTERVENTIONS --Carers in the dementia carers ' programme received training in coping with the difficulties of looking after patients with dementia while the patients had sessions in subjects such as memory retraining . In the memory retraining programme patients were admitted and received the patient component of the carers ' programme while their carers had 10 days ' respite . In the wait list group carers waited six months before undertaking the carers ' programme . MAIN OUTCOME MEASURES --Effect of the programmes on carers ' general health question naire scores and the rate of placement of patients in institutions . RESULTS --At 12 months ' follow up the carers ' programme had result ed in significantly lower psychological stress among carers than the memory retraining programme ( mean ( SD ) general health question naire scores at 0 months were 6.31 ( 6.23 ) and 3.60 ( 6.25 ) respectively , and at 12 months were 4.69 ( 5.58 ) and 7.40 ( 9.39 ) ; p less than 0.05 . ) In the wait list group distress scores remained stable , even after the carers and patients had undertaken the carers ' programme . Patients deteriorated over 12 months regardless of group allocation , but at 30 months , allowing for patients who died and could not be included in the analysis , 65 % of patients in the carers ' programme group were still living at home compared with 26 % in the memory retraining programme group . CONCLUSION --The intensive intervention programme described for carers of patients with dementia can reduce the psychological morbidity of the carer and delay the placement of the patient in an institution without increasing the use of health services by either patient or carer A r and omized 3-year study assessed the effect of exp and ed community-based services and case management on 5,254 caregivers of dementia clients . A tested policy concern was whether the financing of formal care would result in a reduction of informal assistance . Unmet needs task assistance for the demonstration 's treatment group caregivers decreased by 30 percent within 6 months and by about 20 percent over 36 months relative to controls . While treatment group members used slightly more formal care over time , there were no differences between treatment and control groups in primary caregiver hours after 36 months , or in the number of tasks in which primary or secondary caregivers provided assistance OBJECTIVE To determine the effects of attendance at a memory clinic on the psychosocial health of carers . DESIGN R and omized control trial . PARTICIPANTS Fifty community dwelling subjects with mild to moderate dementia and their carers . MAIN OUTCOME MEASURES Carer burden , psychological morbidity and psychosocial health related quality of life at 6 and 12 months post intervention . MAIN RESULTS There was significant improvement in psychosocial health related quality of life of carers as measured by the psychosocial domain of the Functional Limitation Profile ( FLP ) at 6 months ( p < 0.01 ) , including improvement in the subgroups of alertness behaviour ( p < 0.05 ) and social interaction ( p < 0.01 ) , after adjustment for age of subject and baseline scores . The improvement in social interaction was maintained at 12 months ( p < 0.05 ) . There was no significant difference in carer psychological morbidity ( General Health Question naire ) , carer burden ( Zarit family interview ) or carer knowledge of dementia ( Dementia Knowledge Test ) at 6 or 12 months , between groups . CONCLUSIONS These results demonstrate improved psychosocial health related quality of life for carers of those with mild to moderate cognitive impairment attending a memory clinic . Further research in this area is indicated , comparing memory clinic intervention with alternative support PURPOSE We examine 6-month effects of the Environmental Skill-Building Program on caregiver well-being and care recipient functioning and whether effects vary by caregiver gender , race ( White or non-White ) , and relationship ( spouse or nonspouse ) . DESIGN AND METHODS We enrolled 255 family caregivers of community-residing persons with Alzheimer 's disease or related disorders , of whom 190 participated in a follow-up interview . Caregivers were r and omized to a usual care control group or intervention group that received five home contacts and one telephone contact by occupational therapists , who provided education , problem-solving training , and adaptive equipment . Baseline and 6-month follow-up included self-report measures of caregiver objective and subjective burden , caregiver well-being , and care recipient problem behaviors and physical function . RESULTS Compared with controls ( n = 101 ) , intervention caregivers ( n = 89 ) reported less upset with memory-related behaviors , less need for assistance from others , and better affect . Intervention spouses reported less upset with disruptive behaviors ; men reported spending less time in daily oversight ; and women reported less need for help from others , better affect , and enhanced management ability , overall well-being , and mastery relative to control group counterparts . Statistically significant treatment differences were not found for hours helping with instrumental activities of daily living , upset with providing assistance with instrumental activities of daily living and activities of daily living , perceived change in somatic symptoms , White versus non-White caregivers , or care recipient outcomes . IMPLICATION S The Environmental Skill-Building Program reduces burden and enhances caregiver well-being in select domains and has added benefit for women and spouses CONTEXT Exercise training for patients with Alzheimer disease combined with teaching caregivers how to manage behavioral problems may help decrease the frailty and behavioral impairment that are often prevalent in patients with Alzheimer disease . OBJECTIVE To determine whether a home-based exercise program combined with caregiver training in behavioral management techniques would reduce functional dependence and delay institutionalization among patients with Alzheimer disease . DESIGN , SETTING , AND PATIENTS R and omized controlled trial of 153 community-dwelling patients meeting National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer Disease and Related Disorders Association criteria for Alzheimer disease , conducted between June 1994 and April 1999 . INTERVENTIONS Patient-caregiver dyads were r and omly assigned to the combined exercise and caregiver training program , Reducing Disability in Alzheimer Disease ( RDAD ) , or to routine medical care ( RMC ) . The RDAD program was conducted in the patients ' home over 3 months . MAIN OUTCOME MEASURES Physical health and function ( 36-item Short-Form Health Survey 's [ SF-36 ] physical functioning and physical role functioning subscales and Sickness Impact Profile 's Mobility subscale ) , and affective status ( Hamilton Depression Rating Scale and Cornell Depression Scale for Depression in Dementia ) . RESULTS At 3 months , in comparison with the routine care patients , more patients in the RDAD group exercised at least 60 min/wk ( odds ratio [ OR ] , 2.82 ; 95 % confidence interval [ CI ] , 1.25 - 6.39 ; P = .01 ) and had fewer days of restricted activity ( OR , 3.10 ; 95 % CI , 1.08 - 8.95 ; P<.001 ) . Patients in the RDAD group also had improved scores for physical role functioning compared with worse scores for patients in the RMC group ( mean difference , 19.29 ; 95 % CI , 8.75 - 29.83 ; P<.001 ) . Patients in the RDAD group had improved Cornell Depression Scale for Depression in Dementia scores while the patients in the RMC group had worse scores ( mean difference , -1.03 ; 95 % CI , -0.17 to -1.91 ; P = .02 ) . At 2 years , the RDAD patients continued to have better physical role functioning scores than the RMC patients ( mean difference , 10.89 ; 95 % CI , 3.62 - 18.16 ; P = .003 ) and showed a trend ( 19 % vs 50 % ) for less institutionalization due to behavioral disturbance . For patients with higher depression scores at baseline , those in the RDAD group improved significantly more at 3 months on the Hamilton Depression Rating Scale ( mean difference , 2.21 ; 95 % CI , 0.22 - 4.20 ; P = .04 ) and maintained that improvement at 24 months ( mean difference , 2.14 ; 95 % CI , 0.14 - 4.17 ; P = .04 ) . CONCLUSION Exercise training combined with teaching caregivers behavior
Output:
| Various aspects of caregivers ' mental health and burden were studied .
Best results were obtained regarding general mental health .
Other aspects often showed modest and varying results .
Caregivers ' competence was less often addressed .
The effects on the cognitive and physical functioning , behavioural problems and survival of the persons with dementia were modest and inconsistent , whereas their mental health is positively affected and admittance to long stay care is often delayed .
Combined programmes may improve some , not all , aspects of functioning for caregiver and person with dementia . |
MS212421 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Background Quality indicators ( QIs ) are an important tool for improving clinical practice and are increasingly being developed from evidence -based guideline recommendations . We aim ed to identify , select and apply guideline recommendations to develop a set of QIs to measure the implementation of evidence -based practice using routinely recorded clinical data in United Kingdom ( UK ) primary care . Methods We review ed existing national clinical guidelines and QIs and used a four-stage consensus development process to derive a set of ‘ high impact ’ QIs relevant to primary care based upon explicit prioritisation criteria . We then field tested the QIs using remotely extracted , anonymised patient records from 89 r and omly sample d primary care practice s in the Yorkshire region of Engl and . Results Out of 2365 recommendations and QIs originally review ed , we derived a set of 18 QIs ( 5 single , 13 composites – comprising 2–9 individual recommendations ) for field testing . QIs predominantly addressed chronic disease management , in particular diabetes , cardiovascular and renal disease , and included both processes and outcomes of care . Field testing proved to be critical for further refinement and final selection . Conclusions We have demonstrated a rigorous and transparent methodology to develop a set of high impact , evidence -based QIs for primary care from clinical guideline recommendations . While the development process was successful in developing a limited set of QIs , it remains challenging to derive robust new QIs from clinical guidelines in the absence of established systems for routine , structured recording of clinical care BACKGROUND Patients with chronic kidney disease ( CKD ) are at significant risk for cardiovascular disease ( CVD ) . The National Kidney Foundation developed clinical practice guidelines ( Kidney Disease Outcomes Quality Initiative ) for targeting low-density lipoprotein cholesterol ( LDL-C ) goals . OBJECTIVE This study evaluated the extent to which these guidelines were adhered to among patients with CKD and to examine factors associated with the attainment of LDL-C goals . METHODS In this cross-sectional study we evaluated patients with a glomerular filtration rate of 15 to 59 mL/min per 1.73 m² . Patients with previous CVD , who were receiving dialysis , or were post kidney transplant were excluded . Administrative data bases were used to determine the percentage of patients with a fasting lipid profile performed within the previous year , the percentage who attained a LDL-C goal less than 100 mg/dL , and to determine lipid-lowering medications prescribed . Logistic regression analysis was used to identify factors associated with LDL-C goal attainment . RESULTS Of the 4541 patients evaluated , 3157 ( 69.5 % ) had a fasting lipid profile performed within the previous year . Overall , 60.8 % attained a LDL-C less than 100 mg/dL. Among patients at goal , 72.2 % were taking lipid-lowering therapy compared with 37.9 % of those not at goal ( P < .01 ) . Characteristics independently associated with LDL-C goal attainment were increasing age , male gender , increasing chronic disease score , history of diabetes , and statin use . CONCLUSION Although most patients were screened and attained LDL-C goal , there was room for improvement . Statin use was independently associated with LDL-C goal attainment . Future prospect i ve studies should focus on evaluating clinical outcomes of lipid-lowering interventions within the CKD population AIMS The study aim ed to assess the prevalence , quality of screening and treatment of chronic kidney disease ( CKD ) , and their trends between 2001 and 2007 , in French adults with type 2 diabetes ( T2D ) . METHODS The 2007 ENTRED survey r and omly selected , from French medical insurance fund data bases , 8926 adults treated for diabetes who had been reimbursed at least three times over the previous 12 months for oral hypoglycaemic agents or insulin . Medical reimbursement data were extracted and two sets of question naires were mailed , one to all patients ( 48 % response rate ) and the other to their doctors ( 62 % ) . Analyses were restricted to the 3894 responders with T2D ( 2232 with data from their doctors ) . Trends between the 2001 and 2007 ENTRED surveys were studied . RESULTS Participants ' mean age was 66 years . The prevalence of CKD was estimated to be at least 29 % , based on doctors ' data ( missing data included ) . Overall , only 17 % had no cl aims for serum creatinine measurements during the year , and 71 % had no cl aims for albuminuria tests ; nonetheless , both figures had decreased from 2001 . Older people , those who lived alone and those who felt poorly informed about diabetes were more likely to have made no cl aims for CKD screening . Assessment of quality of care ( prescribing antihypertensive treatment when indicated ) was possible for 66 % of responders , of whom 25 % did not receive such treatment . CONCLUSION CKD is frequently seen in patients with T2D and is likely to be underestimated because albuminuria screening remains inadequate , despite significant improvements since 2001 . Further efforts are needed to improve CKD screening , patient and doctor awareness , and adequate use of antihypertensive/nephroprotective medications Cardiovascular disease ( CVD ) is a major cause of morbidity and mortality among patients with chronic renal insufficiency ( CRI ) . beta-Adrenergic blockers , acetylsalicylic acid ( ASA ) , angiotensin-converting enzyme ( ACE ) inhibitors , and 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors ( statins ) all reduce CVD mortality , but little is known about the extent to which these medications are used in patients with CRI . This study , a prospect i ve cross-sectional study of consecutive patients seen by nephrologists in four Canadian centers for follow-up of progressive CRI in 1999 , was performed to investigate the prevalence of coronary risk factors and use of cardioprotective medications among patients with CRI . Patients had creatinine clearances of 75 mL/min or less but were not on dialysis therapy . Three hundred four consecutive patients meeting the inclusion criteria were enrolled . Mean age was 60.8 + /- 15.7 years , mean creatinine clearance was 30.3 + /- 18 mL/min , and the case mix of kidney diseases was similar to that in the Canadian Organ Replacement Registry data . One hundred seventeen of 304 patients ( 38.5 % ) had a history of previous CVD , and the prevalence of CVD was greater in patients with more severe CRI . Two hundred forty-three patients ( 79.9 % ) had a history of hypertension , 132 patients ( 43.4 % ) had hyperlipidemia , 114 patients ( 37.5 % ) had diabetes mellitus , and 71 patients ( 27.3 % ) were smokers . Thirty-five percent of the patients with CVD had blood pressures greater than 140/90 mm Hg ; 103 patients ( 33.9 % ) were administered beta-blockers ; 196 patients ( 64.5 % ) , ACE inhibitors or angiotensin-receptor blockers ; 83 patients ( 27.3 % ) , ASA ; and 56 patients ( 18.4 % ) , statins . Patients with diabetes were not more likely than those without diabetes to be prescribed cardioprotective medications . CVD is common in the predialysis population , and its prevalence increases with more severe kidney failure . Despite this , the use of cardioprotective medications is relatively low , and many patients had suboptimal blood pressure control . Given the high burden of disease in these patients , beta-blockers and ACE inhibitors should be used to control hypertension and /or for cardioprotection , and the increased use of ASA and statins should be considered BACKGROUND Current recommendations for the management of chronic renal insufficiency ( CRI ) include the use of angiotensin-converting enzyme inhibitors ( ACEI ) and achieving target blood pressure control . We design ed this study to describe the use of these therapeutic strategies , and to investigate barriers to their implementation . METHODS This was a prospect i ve study of 304 consecutive CRI patients , seen at follow-up in four nephrology clinics across Canada . The use of blood pressure control and antihypertensive medication ( AHM ) in each of these clinics was recorded , and a question naire was administered to nephrologists to determine the basis for decisions concerning AHM regimens and ACEI use/non-use . RESULTS Mean age was 60.8+/-15.7 years , mean creatinine clearance was 30.3+/-18 ml/min , and underlying renal diseases were similar to registry data . Mean arterial pressure ( MAP ) achieved was 99.4+/-14.4 and 98.9+/-11.9 mmHg in individuals with > 1 and < /=1 g/day proteinuria , respectively . When similarly stratified by proteinuria , mean systolic blood pressures were 141.4+/-23.5 and 140.9+/-20.3 mmHg , and mean diastolic blood pressures were 78.4+/-14.0 and 77.9+/-11.4 mmHg , respectively . Blood pressure control , according to published guidelines , was achieved in 128 patients ( 42.1 % ) . A further 86 ( 28.3 % ) patients had their AHM increased . The remaining 90 ( 29.6 % ) did not have their AHM increased . Of these , 40 were labelled ' at target blood pressure ' ( mean MAP 100.5+/-5.4 mmHg ) , 19 ' office hypertension ' and 11 ' unfavourable risk/benefit ratios ' . There were 108/304 ( 35.5 % ) patients who were not taking ACEI or ARB ( angiotensin receptor antagonist ) : 34/108 ( 31 % ) had previous ACEI failure due to hyperkalaemia ( 21/108 , 19 % ) or acute renal failure ( 17/108 , 16 % ) , and 61/108 ( 55 % ) were felt ' unlikely to benefit ' ( categories not mutually exclusive ) . Miscommunication with the primary physician and medication costs were not identified as significant barriers to improved blood pressure control or ACEI use . CONCLUSIONS Approximately 40 % of CRI patients are achieving current blood pressure goals and 64 % are prescribed ACEI/ARB in tertiary care nephrology clinics . Although the use of these strategies may be increasing , there remains room for improvement . Physicians should remain aware of the need to use these proven strategies in patients with CRI BACKGROUND The implementation of national estimated glomerular filatration rate reporting and the inclusion of renal-specific indicators in a primary care pay for performance ( P4P ) system since April 2006 has promoted identification and better management of risk factors related to chronic kidney disease ( CKD ) . In the UK , the P4P framework is known as the Quality and Outcomes Framework ( QOF ) . One of the key targets for intervention in primary care was hypertension . It is clear that hypertension is a major predictor of development and progression of CKD ; thus , targeting better blood pressure control is likely to have a positive impact on outcomes in CKD . The aim of this study was to evaluate the effectiveness of renal indicators outlined in P4P on the management of hypertension in primary care . To estimate the cost implication s of the result ing changes in prescribing patterns of antihypertensive medication following introduction of such indicators . METHODS We performed a prospect i ve cohort study using a large primary care data base . This cohort was taken from a data base collated as part of a clinical decision support system used to assist the management of CKD in primary care . We investigated a total population of 90 250 individuals on general practitioner ( GP ) registers with a valid serum creatinine estimation in the 6-year study period . A total of 10 040 patients had confirmed stage 3 - 5 CKD in the 2 years pre-QOF and formed the study cohort . Patients were studied over three time periods , pre-QOF ( 1 April 2004 to 31 March 2006 ) , 2 years post-QOF ( 1 April 2006 to 31 March 2008 ) and finally the two subsequent years ( 1 April 2008 to 31 March 2010 ) . The mean systolic and diastolic blood pressures ( BP ) together with antihypertensive medication were analysed over the three time periods . Cost calculation was based on 2009 British National Formulary list prices for antihypertensives . RESULTS The mean age of the cohort at the start of the study period was 64.8 years , 55 % were female . In those patients with stage 3 - 5 CKD 83.9 % were hypertensive , defined by a pre-P4P BP of > 140/85 or currently taking antihypertensive medication . The proportion of patients with CKD 3 - 5 attaining the BP target of 145/80 increased from 41.5 % in the pre-QOF period to 50.0 % in the post-QOF period . This increase was even more marked for those with hypertension in the pre-QOF period ( 28.8 - 45.1 % ) . In the hypertensive patients , mean BP fell from 146/
Output:
| CONCLUSIONS Based on this review , sufficiently vali date d QIs can be selected for measuring the quality of CKD care . |
MS212422 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE Study the effects of exenatide ( EXE ) plus rosiglitazone ( ROSI ) on β-cell function and insulin sensitivity using hyperglycemic and euglycemic insulin clamp techniques in participants with type 2 diabetes on metformin . RESEARCH DESIGN AND METHODS In this 20-week , r and omized , open-label , multicenter study , participants ( mean age , 56 ± 10 years ; weight , 93 ± 16 kg ; A1C , 7.8 ± 0.7 % ) continued their metformin regimen and received either EXE 10 μg b.i.d . ( n = 45 ) , ROSI 4 mg b.i.d . ( n = 45 ) , or EXE 10 μg b.i.d . + ROSI 4 mg b.i.d . ( n = 47 ) . Seventy-three participants underwent clamp procedures to quantitate insulin secretion and insulin sensitivity . RESULTS A1C declined in all groups ( P < 0.05 ) , but decreased most with EXE+ROSI ( EXE+ROSI , −1.3 ± 0.1 % ; ROSI , −1.0 ± 0.1 % , EXE , −0.9 ± 0.1 % ; EXE+ROSI vs. EXE or ROSI , P < 0.05 ) . ROSI result ed in weight gain , while EXE and EXE+ROSI result ed in weight loss ( EXE , −2.8 ± 0.5 kg ; EXE+ROSI , −1.2 ± 0.5 kg ; ROSI , + 1.5 ± 0.5 kg ; P < 0.05 between and within all groups ) . At week 20 , 1st and 2nd phase insulin secretion was significantly higher in EXE and EXE+ROSI versus ROSI ( both P < 0.05 ) . Insulin sensitivity ( M value ) was significantly higher in EXE+ROSI versus EXE ( P = 0.014 ) . CONCLUSIONS Therapy with EXE+ROSI offset the weight gain observed with ROSI and elicited an additive effect on glycemic control with significant improvements in β-cell function and insulin sensitivity OBJECTIVE Glucagon-like peptide (GLP)-1 is a gut hormone that exerts incretin effects and suppresses food intake in humans , but its therapeutic use is limited due to its short half-life . This was a r and omized , double-blind , parallel-group , placebo-controlled trial investigating the effect of the long-acting GLP-1 derivative liraglutide ( NN2211 ) on glycemic control , body weight , body composition , and 24-h energy expenditure in obese subjects with type 2 diabetes . RESEARCH DESIGN AND METHODS Thirty-three patients ( mean + /- SD ) aged 60.0 + /- 9.5 years , with HbA(1c ) 7.5 + /- 1.2 % and BMI 36.6 + /- 4.1 kg/m(2 ) , were r and omized to treatment with a single daily subcutaneous dose of 0.6 mg liraglutide ( n = 21 ) or placebo ( n = 12 ) for 8 weeks . In addition to weight and glycemic parameters , body composition was assessed by dual-energy X-ray absorptiometry ( DEXA ) scanning and 24-h energy expenditure in a respiratory chamber . RESULTS After 8 weeks , liraglutide reduced fasting serum glucose ( liraglutide , -1.90 mmol/l , and placebo , 0.27 mmol/l ; P = 0.002 ) and HbA(1c ) ( liraglutide , -0.33 % , and placebo , 0.47 % ; P = 0.028 ) compared with placebo . No change in body weight was detected ( liraglutide , -0.7 kg , and placebo , -0.9 kg ; P = 0.756 ) . There was a nonsignificant trend toward a decrease in total fat mass ( liraglutide , -0.98 % , and placebo , -0.12 % ; P = 0.088 ) and toward an increase in lean body mass ( liraglutide , 1.02 % , and placebo , 0.23 % ; P = 0.118 ) in the liraglutide group compared with the placebo group . Twenty-four-hour energy expenditure was unaffected by the treatment ( liraglutide , -12.6 kJ/h , and placebo , -13.7 kJ/h ; P = 0.799 ) . CONCLUSIONS Eight weeks of 0.6-mg liraglutide treatment significantly improved glycemic control without increasing weight in subjects with type 2 diabetes compared with those on placebo . No influence on 24-h energy expenditure was detected Aim The aim of this study was to compare the efficacy and safety of once-daily human glucagon-like peptide-1 analogue liraglutide with dipeptidyl peptidase-4 inhibitor sitagliptin , each added to metformin , over 52 weeks in individuals with type 2 diabetes . Methods In an open-label , parallel-group trial , metformin-treated participants were r and omised to liraglutide 1.2 mg/day ( n= 225 ) , liraglutide 1.8 mg/day ( n= 221 ) or sitagliptin 100 mg/day ( n= 219 ) for 26 weeks ( main phase ) . Participants continued the same treatment in a 26-week extension . Results Liraglutide ( 1.2 or 1.8 mg ) was superior to sitagliptin for reducing HbA1c from baseline ( 8.4–8.5 % ) to 52 weeks : −1.29 % and −1.51 % vs. −0.88 % respectively . Estimated mean treatment differences between liraglutide and sitagliptin were as follows : −0.40 % ( 95 % confidence interval −0.59 to −0.22 ) for 1.2 mg and −0.63 % ( −0.81 to −0.44 ) for 1.8 mg ( both p < 0.0001 ) . Weight loss was greater with liraglutide 1.2 mg ( −2.78 kg ) and 1.8 mg ( −3.68 kg ) than sitagliptin ( −1.16 kg ) ( both p < 0.0001 ) . Diabetes Treatment Satisfaction Question naire scores increased significantly more with liraglutide 1.8 mg than with sitagliptin ( p = 0.03 ) . Proportions of participants reporting adverse events were generally comparable ; minor hypoglycaemia was 8.1 % , 8.3 % and 6.4 % for liraglutide 1.2 mg , 1.8 mg and sitagliptin respectively . Gastrointestinal side effects , mainly nausea , initially occurred more frequently with liraglutide , but declined after several weeks . Conclusion Liraglutide provides greater sustained glycaemic control and body weight reduction over 52 weeks . Treatment satisfaction was significantly greater with 1.8 mg liraglutide , similar to 26-week results . The safety profiles of liraglutide and sitagliptin are consistent with previous reports OBJECTIVE This multicenter , open-label , parallel-arm study compared the efficacy and safety of exenatide once weekly ( EQW ) with titrated insulin detemir in patients with type 2 diabetes inadequately controlled with metformin ( with or without sulfonylureas ) . RESEARCH DESIGN AND METHODS Patients were r and omized to EQW ( 2 mg ) or detemir ( once or twice daily , titrated to achieve fasting plasma glucose ≤5.5 mmol/L ) for 26 weeks . The primary outcome was proportion of patients achieving A1C ≤7.0 % and weight loss ≥1.0 kg at end point , analyzed by means of logistic regression . Secondary outcomes included measures of glycemic control , cardiovascular risk factors , and safety and tolerability . RESULTS Of 216 patients ( intent-to-treat population ) , 111 received EQW and 105 received detemir . Overall , 44.1 % ( 95 % CI , 34.7–53.9 ) of EQW-treated patients compared with 11.4 % ( 6.0–19.1 ) of detemir-treated patients achieved the primary outcome ( P < 0.0001 ) . Treatment with EQW result ed in significantly greater reductions than detemir in A1C ( least-square mean ± SE , −1.30 ± 0.08 % vs. −0.88 ± 0.08 % ; P < 0.0001 ) and weight ( −2.7 ± 0.3 kg vs. + 0.8 ± 0.4 kg ; P < 0.0001 ) . Gastrointestinal-related and injection site – related adverse events occurred more frequently with EQW than with detemir . There was no major hypoglycemia in either group . Five ( 6 % ) patients in the EQW group and six ( 7 % ) patients in the detemir group experienced minor hypoglycemia ; only one event occurred without concomitant sulfonylureas ( detemir group ) . CONCLUSIONS Treatment with EQW result ed in a significantly greater proportion of patients achieving target A1C and weight loss than treatment with detemir , with a low risk of hypoglycemia . These results suggest that EQW is a viable alternative to insulin detemir treatment in patients with type 2 diabetes with inadequate glycemic control using oral antidiabetes drugs Mixed treatment comparison ( MTC ) meta- analysis is a generalization of st and ard pairwise meta- analysis for A vs B trials , to data structures that include , for example , A vs B , B vs C , and A vs C trials . There are two roles for MTC : one is to strengthen inference concerning the relative efficacy of two treatments , by including both ' direct ' and ' indirect ' comparisons . The other is to facilitate simultaneous inference regarding all treatments , in order for example to select the best treatment . In this paper , we present a range of Bayesian hierarchical models using the Markov chain Monte Carlo software WinBUGS . These are multivariate r and om effects models that allow for variation in true treatment effects across trials . We consider models where the between-trials variance is homogeneous across treatment comparisons as well as heterogeneous variance models . We also compare models with fixed ( unconstrained ) baseline study effects with models with r and om baselines drawn from a common distribution . These models are applied to an illustrative data set and posterior parameter distributions are compared . We discuss model critique and model selection , illustrating the role of Bayesian deviance analysis , and node-based model criticism . The assumptions underlying the MTC models and their parameterization are also discussed OBJECTIVE We recently reported that after 26 weeks , exenatide once weekly ( EQW ) result ed in superior A1C reduction , reduced hypoglycemia , and progressive weight loss compared with daily insulin glargine ( IG ) in patients with type 2 diabetes who were taking metformin alone or with sulfonylurea . This 84-week extension study assessed the long-term safety and efficacy of EQW versus IG . RESEARCH DESIGN AND METHODS This multicenter , open-label , r and omized , two-arm , parallel trial assessed change in A1C , proportions of patients achieving A1C < 7.0 and ≤6.5 % , body weight , incidence of hypoglycemia , and overall safety . RESULTS Of 415 patients who completed 26 weeks , 390 ( 194 EQW and 196 IG patients ) entered the extension study . At 84 weeks , A1C decreased from baseline ( 8.3 % ) by −1.2 % for EQW vs. −1.0 % for IG ( P = 0.029 ) . The proportions of patients who achieved end point A1C targets < 7.0 and ≤6.5 % were 44.6 % for EQW patients vs. 36.8 % for IG patients ( P = 0.084 ) and 31.3 % for EQW patients vs. 20.2 % for IG patients ( P = 0.009 ) , respectively . Patients taking EQW lost 2.1 kg of body weight , whereas those taking IG gained 2.4 kg ( P < 0.001 ) . Among patients taking metformin plus sulfonylurea , the incidence of minor hypoglycemia was 24 % for EQW patients vs. 54 % for IG patients ( P < 0.001 ) ; among patients taking metformin alone , it was 8 % for EQW patients vs. 32 % for IG patients ( P < 0.001 ) . Among adverse events occurring in ≥5 % of patients , diarrhea and nausea occurred more frequently ( P < 0.05 ) in the EQW group than in the IG group ( 12 vs. 6 % and 15 vs. 1 % , respectively ) . CONCLUSIONS After 84 weeks , patients treated with EQW continued to experience better glycemic control with sustained overall weight loss and a lower risk of hypoglycemia than patients treated with IG OBJECTIVE To determine the effect of a lifestyle modification program plus exenatide versus lifestyle modification program plus placebo on weight loss in overweight or obese
Output:
| Some GLP-1RAs , especially liraglutide—1.8 mg once daily and liraglutide—1.2 mg once daily , were associated with a significant reduction in waist circumference |
MS212423 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more OBJECTIVE To compare perinatal outcomes among women with epidural anesthesia who were encouraged to push at complete dilatation with those who had a period of rest before pushing began . METHODS After a power analysis to determine appropriate sample size ( based upon an α error rate of .05 % and 80 % power ) , a prospect i ve r and omized trial of 252 women with epidural anesthesia was conducted . Patients were r and omized to a rest period or immediate pushing at complete dilatation . Variables measured included rate of fetal descent , length of time of pushing , the number and type of fetal heart rate decelerations , Apgar scores , arterial cord pH values , perineal injuries , type of delivery , length of second stage , maternal fatigue , and endometritis . RESULTS When a period of rest was used before pushing , we found a longer second stage , decreased pushing time , fewer decelerations , and , in primiparous women , less fatigue compared with control patients . Apgar scores , arterial cord pH values , rates of perineal injury , instrument delivery , and endometritis were similar in both groups . CONCLUSION Delayed pushing was not associated with demonstrable adverse outcome , despite second‐stage length of up to 4.9 hours . In select patients , such delay may be of benefit OBJECTIVE This study was undertaken to determine whether a policy of delayed pushing for nulliparous women with continuous-infusion epidural analgesia reduces the risk of difficult delivery ( cesarean delivery , operative delivery from a midpelvic position , low-pelvic procedures with rotation > 45 degrees ) . STUDY DESIGN In this multicenter , r and omized , controlled trial women in the delayed pushing group ( n = 936 ) were advised to wait > or = 2 hours after full dilatation before commencement of pushing . Women in the early pushing group ( n = 926 ) were advised to commence pushing as soon as they had been r and omly assigned . RESULTS Difficult delivery was reduced with delayed pushing ( relative risk , 0.79 ; 95 % confidence interval , 0.66 - 0.95 ) . The greatest effect was on midpelvic procedures ( relative risk , 0.72 ; 95 % confidence interval , 0.55 - 0.93 ) . Although there was little evidence for an effect on low-pelvic procedures , spontaneous delivery was more frequent among women who practice d delayed pushing ( relative risk , 1.09 ; 95 % confidence interval , 1.00 - 1.18 ) . Abnormal umbilical cord blood pH ( < 7.15 venous value or < 7.10 arterial value ) was more frequent in the delayed pushing group ( relative risk , 2.45 , 95 % confidence interval , 1.35 - 4 . 43 ) . However , scores for a summary indicator , the Neonatal Morbidity Index , were similarly distributed in the 2 groups . CONCLUSION Delayed pushing is an effective strategy to reduce difficult deliveries among nulliparous women OBJECTIVE To determine if waiting for a strong urge to push in nulliparas with continuous low-concentration epidural analgesia shortens the pushing duration in the second stage . METHODS Nulliparas with st and ardized patient-controlled epidural analgesia ( 0.0625 % bupivacaine with fentanyl 2 μg/mL ) were r and omly assigned to pushing immediately upon complete cervical dilatation ( n = 85 ) or waiting for a strong urge to push ( n = 117 ) . Urge to push and patient satisfaction were quantified on 100-mm visual analogue scales . Duration of pushing and total duration of the second stage were analyzed as survival time data . RESULTS Women who delayed pushing and those who pushed immediately were similar with respect to maternal characteristics . Women who delayed pushing had a stronger urge to push ( P < .01 ) and a longer second stage ( P < .05 ) than women who pushed immediately . There was no significant difference in the time spent pushing ( median 57 versus 62 minutes , respectively ) or the median level of patient satisfaction ( 80 mm for both groups ) . There were no significant differences in the overall rates of cesarean delivery ( 6 % versus 12 % , respectively ) , cesarean delivery during the second stage ( 2 % in each group ) , spontaneous vaginal delivery ( 70 % versus 69 % , respectively ) , or neonatal or maternal morbidity . CONCLUSION In nulliparas with continuous low-concentration epidural analgesia , delaying pushing until a strong urge is felt does not reduce the duration of pushing in the second stage of labor Objective To identify the obstetric factors relating to anal sphincter injury at first vaginal delivery by prospect i ve cohort study of primiparous women . Methods We compared the results of a bowel function question naire and anal vector manometry before and 6 weeks after delivery in 184 primiparous women . Postpartum , pudendal nerve conduction latency was measured in all women , and anal endosonography was performed in 81 with altered fecal continence or abnormal physiology . Results Sixteen ( 9 % ) women , none of whom had altered fecal continence , were delivered by cesarean . After vaginal delivery , 42 of 168 ( 25 % ) women had impairment of fecal continence and 76 of 168 ( 45 % ) women had abnormal anal physiology . Instrumental vaginal delivery was associated with an 8.1-fold ( 95 % confidence interval [ CI ] 2.7 , 24.0 ; P < .001 ) risk of anal sphincter injury and a 7.2-fold ( 95 % CI 2.8 , 18.6 ; P < .001 ) risk of symptoms . Duration of the second stage of labor beyond 60 minutes led to a 1.7-fold ( 95 % CI 1.14 , 2.48 ; P ; < .01 ) risk of anal sphincter injury and a 1.6-fold ( 95 % CI 1.03 , 2.6 , P = .01 ) risk of symptoms . Epidural analgesia , used in 58 % of vaginal deliveries , prolonged the second stage of labor ( P = .004 ; odds ratio [ OR ] 7.7 ; 95 % CI 4.0 , 14.7 ) and was associated with increased risk of sphincter injury ( P = .02 ; OR 2.1 ; 95 % CI 1.1 , 4.0 ) and of symptoms ( P = .02 ; OR 2.0 ; 95 % CI 1.1 , 3.7 ) . Conclusion Instrumental delivery and a second stage of labor prolonged by epidural analgesia are the obstetric factors that pose the greatest risk of injury to the anal sphincter mechanism in primiparous vaginal delivery Seventy-six primigravidae with epidural analgesia were r and omly assigned to one of two groups for management in the second stage . In one group the women delayed pushing and in the other they were managed conventionally . The two groups were well matched for maternal and infant characteristics , including position and level of the presenting part at full dilatation and fetal scalp blood pH. The mean waiting time in the second stage before pushing was increased from 27 min in the conventional group to 123 min in the delayed group . This delay was not associated with an increase in abnormal fetal heart rate abnormalities or any decrease in umbilical cord pH or Apgar scores . In contrast , the delay was associated with an increase in spontaneous deliveries and a decrease in forceps deliveries ( P = 0.06 ) . These findings suggest a need for redefining the management of the second stage of labour with epidural analgesia OBJECTIVE To determine if the use of delayed pushing after the onset of the second stage of labor decreases the time of active pushing and decreases maternal fatigue . DESIGN R and omized clinical trial . SETTING Labor and delivery unit of a not-for-profit community hospital . PATIENTS / PARTICIPANTS Convenience sample of nulliparous laboring women with epidural anesthesia . INTERVENTIONS Immediate or delayed pushing ( 2 hours ) during the second stage of labor at the time of complete cervical dilatation . MAIN OUTCOME MEASURES The length of pushing , total length of the second stage , and maternal fatigue . RESULTS A total of 77 women were studied ( immediate pushing group=39 ; delayed pushing=38 ) . The immediate pushing group averaged 94 ( ± 57 ) minutes in active pushing , while the delayed pushing group averaged 68 ( ± 46 ) minutes , a statistically significant difference ( p=.04 ) . No significant differences were found in fatigue scores between the immediate and delayed pushing groups ( p>.05 ) . CONCLUSIONS We found that by delaying the onset of active pushing for 2 hours after the beginning of the second stage of labor , the time that nulliparous women with epidural anesthesia spent in active pushing was significantly decreased by 27 % . Although the delayed pushing group rested for up to 2 hours , the total time in the second stage of labor averaged only 59 minutes longer than the immediate pushing group OBJECTIVE To compare outcomes between women receiving epidural anesthesia assigned to a group following either a 1-hour " delayed " pushing protocol or directed to initiate pushing at full cervical dilation . STUDY DESIGN Using a r and omized , controlled design , multivariate analyses were used to evaluate second stage labor duration and Apgar scores . An estimated odds ratio equation evaluated fetal descent progress . RESULTS A 13.68-minute difference occurred in second stage labor length ( p = 0.225 ) . No differences were found in Apgar scores ( p > 0.09 ) . An estimated odds ratio , that progress in terms of one fetal station unit would occur for control group subjects as compared with subjects with similar progress in the experimental group , was 1.51 ( 95 % confidence interval : 1.16 , 1.95 ) . CONCLUSION Second stage labor was not significantly lengthened , and a similar rate of fetal descent occurred in the absence of directed pushing . Findings support further research on the potential advantages of minimizing the duration of pushing in labor Objective To assess the effects of delayed vs immediate pushing in second stage of labour with epidural analgesia on delivery outcome , postpartum faecal continence and postpartum anal sphincter and pudendal nerve function Background Although there are two methods of caring for women with epidural anesthesia during second-stage labor ( coached closed-glottis pushing immediately at 10-cm cervical dilation or delayed pushing until the woman feels the urge to push , passive fetal descent , and encouragement of open-glottis pushing when the woman has the urge to push ) , there are limited data concerning which method is most optimal for fetal well-being . Objective To evaluate effects on fetal well-being , as measured by fetal oxygen saturation , of two different methods of second-stage labor nursing care for women with epidural anesthesia . Methods Forty-five nulliparous women who had progressed to the second stage were r and omized to 1 of 2 groups ( immediate or delayed pushing ) . Fetal oxygen saturation was continuously monitored and values at 10 cm , initiation of pushing and immediately prior to birth , as well as the amount of time that fetal oxygen saturation values were abnormal ( ≤30 % ) were compared between groups . Also evaluated were additional measures of fetal well-being such as fetal heart rate patterns , Apgar scores , and umbilical cord blood gases and maternal outcomes including length of labor , method of birth , and perineal status . Results There was a significant difference between groups in fetal oxygen desaturation during the second stage ( immediate : M = 12.5 ; delayed : M = 4.6 ) F(1 , 43 ) = 12.24 , p = .001 , and in the number of ≥2-min epochs of fetal oxygen saturation < 30 % ( immediate : M = 7.9 ; delayed : M = 2.7 ) , F(1 , 43 ) = 6.23 , p = .02 . There were more variable decelerations of the fetal heart rate in the immediate pushing group ( immediate : M = 22.4 ; delayed : M = 15.6 ) F(1 , 43 ) = 5.92 , p = .02 . There were no differences in length of labor , method of birth , Apgar scores , or umbilical cord blood gases . Women who pushed immediately had more perineal lacerations ( immediate : n = 13 ; delayed : n = 5 ) χ2(1 , N = 45 ) = 6.54 , p = .01 . Discussion Delayed pushing results in less fetal oxygen desaturation and less ≥2-min epochs of fetal oxygen saturation < 30 % during second-stage labor than the immediate pushing method ; thus , delayed pushing is more favorable for fetal well-being as measured by fetal oxygen saturation OBJECTIVES This study was undertaken to examine the national and regional rates of operative delivery among almost one quarter million births in a single year in the nation 's largest healthcare delivery system , using variation as an arbiter of the quality of decision making . STUDY DESIGN We compared the variation in rates of primary cesarean and operative vaginal delivery in facilities of the Hospital Corporation of America during the year 2004 . RESULTS In 124 facilities representing almost 220,000 births during a 1-year period , the primary cesarean and operative vaginal delivery rates were 19 % + /- 5 % ( range 9 - 37 ) and 7 % + /- 4 % ( range 1 - 23 ) . Within individual geographic
Output:
| : Studies to date suggest there are few clinical differences in outcomes with immediate compared with delayed pushing in the second stage of labor , especially when high- quality studies are pooled .
Effects on maternal and neonatal outcomes remain uncertain |
MS212424 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size Abstract A previously established relationship for deriving dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics has been tested using an independent data set . Individual patient information from 18 RCTs of parallel‐group design in acute postoperative pain ( after abdominal , gynaecological and oral surgery ) was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with > 50%maxTOTPAR for the different treatments . The relationship between the measures was investigated in 85 treatments with over 3400 patients . In 80 of 85 treatments ( 94 % ) agreement between calculated and actual number of patients with > 50%maxTOTPAR was within four patients per treatment and in 72 ( 85 % ) was within three ( average of 40 patients per treatment , range 21–58 patients ) . Summing the positive and negative differences between actual and calculated numbers of patients with > 50%maxTOTPAR gave an average difference of 0.30 patients per treatment arm . Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events , such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data in acute pain studies enables data published as means to be used for quantitative systematic review s which require data in dichotomous form & NA ; Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events — such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data , at least in acute pain models , indicates that more meaningful overviews or meta‐ analysis may be possible . This study investigated the relationship between continuous and dichotomous analgesic measures in a set of individual patient data , and then used that relationship to derive dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics . Individual patient information from 13 RCTs of parallel‐group and crossover design in acute postoperative pain was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with greater than 50 % pain relief ( > 50%maxTOTPAR ) for the different treatments . The relationship between the measures was investigated in 45 actual treatments and 10 000 treatments simulated using the underlying actual distribution ; 1283 patients had 45 separate treatments . Mean % maxTOTPAR correlated with the proportion of patients with > 50%maxTOTPAR ( r2 = 0.90 ) . The relationship calculated from all the 45 treatments predicted to within three patients the number of patients with more than 50 % pain relief in 42 of 45 treatments , and 98.8 % of 10 000 simulated treatments . For seven effective treatments , actual numbers‐needed‐to‐treat ( NNT ) to achieve > 50%maxTOTPAR compared with placebo were very similar to those derived from calculated data & NA ; A data base of r and omised clinical trials ( RCTs ) in pain research published from 1950 to 1990 was created following an extensive literature search . By applying a refined MEDLINE search strategy from 1966 to 1990 and by h and ‐ search ing more than 1 000 000 pages of a total of 40 biomedical journals published during the period 1950–1990 , more than 8000 RCTs were identified . The RCTs were published in more than 800 journals and over 85 % appeared between 1976 and 1990 . If the trend of the last 15 years persists , a total of more than 15 000 RCTs will be published in pain relief by the year 2000 . A detailed description of methods to ensure efficient use of re sources during the identification , retrieval and management of the information in pain relief and other fields is given . Emphasis is made on the importance of refining MEDLINE search strategies , on the use of volunteers to h and ‐ search journals and on careful monitoring of each of the steps of the process . The potential uses of the data base to guide clinical and research decisions are discussed Abstract One way to ensure adequate sensitivity for analgesic trials is to test the intervention on patients who have established pain of moderate to severe intensity . The usual criterion is at least moderate pain on a categorical pain intensity scale . When visual analogue scales ( VAS ) are the only pain measure in trials we need to know what point on a VAS represents moderate pain , so that these trials can be included in meta‐ analysis when baseline pain of at least moderate intensity is an inclusion criterion . To investigate this we used individual patient data from 1080 patients from r and omised controlled trials of various analgesics . Baseline pain was measured using a 4‐point categorical pain intensity scale and a pain intensity VAS under identical conditions . The distribution of the VAS scores was examined for 736 patients reporting moderate pain and for 344 reporting severe pain . The VAS scores corresponding to moderate or severe pain were also examined by gender . Baseline VAS scores recorded by patients reporting moderate pain were significantly different from those of patients reporting severe pain . Of the patients reporting moderate pain 85 % scored over 30 mm on the corresponding VAS , with a mean score of 49 mm . For those reporting severe pain 85 % scored over 54 mm with a mean score of 75 mm . There was no difference between the corresponding VAS scores of men and women . Our results indicate that if a patient records a baseline VAS score in excess of 30 mm they would probably have recorded at least moderate pain on a 4‐point categorical scale
Output:
| AUTHORS ' CONCLUSIONS In the absence of evidence of efficacy , at present , for oral nabumetone in acute postoperative pain , its use in this indication is not justified . |
MS212425 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The conservative technique of professionally dispensed and supervised , home-administered vital bleaching is now a routine treatment in the dental profession . This double-blind study evaluated the Rembr and t Lightening Gel and Whitening Toothpaste for shade change , colorimeter shade change . As well , it evaluated soft tissue health by periodontal probing , plaque index , and bleeding index . A patient question naire evaluated perception of whitening , perception of oral hygiene , average hours per day , and average days per week . Bleaching trays were worn over a 4-week period . The bleaching system showed definitive whitening effects as evaluated with the Vita shade guide and the colorimeter . The bleaching system had no deleterious effects on the soft tissue . The Rembr and t toothpaste alone demonstrated two-shade lightening . This vital bleaching system shows definitive whitening of the teeth in short periods of time with no adverse effects To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results PURPOSE To compare the clinical response of two self-directed vital bleaching systems under market use conditions . MATERIAL S AND METHODS A r and omized , parallel-group clinical trial was conducted . A total of 20 healthy adults were r and omized to either a 6.0 % hydrogen peroxide strip-based bleaching system or a combination system involving a 10 % carbamide peroxide gel in a stock tray along with an anticavity whitening dentifrice and after-bleaching whitening mouthrinse . Only the maxillary arch was bleached over a 14-day period . Subjects were evaluated at 3 , 8 and 15 days . Efficacy was measured objective ly using digital image analysis to derive individual color parameters ( L*a*b * ) and overall color change ( deltaE * ) . RESULTS After 14 days , the adjusted mean reduction in yellow ( Ab * ) was -2.23 + /- 0.157 for the whitening strips compared to -0.97 + /- 0.188 for the combination system . This represented a highly statistically significant ( P < 0.0001 ) , two-fold superior reduction in yellowness for the whitening strip group compared to the marketed control . Similar results were seen for other color parameters , with the whitening strip group exhibiting two-fold color improvement relative to the tray/dentifrice/rinse combination . With respect to tolerability , tooth sensitivity and oral irritation were the most common findings . Considering event duration and severity , median bleaching tolerability severity-days scores were 0.07 and 0.58 for the strip and combination systems respectively , with these treatments differing statistically ( P= 0.04 1 ) favoring the whitening strips A r and omized , parallel , examiner-blind clinical trial was conducted to compare two professionally dispensed vital bleaching systems . A total of 20 subjects were r and omized to either the Crest Professional Whitestrips system or the Nite White Excel 2 tray system , balancing for baseline tooth color . During the 2-week treatment period , subjects were instructed to use the strip system for one-half hour twice daily ( 14 contact hours ) and the tray system for 2 hours daily ( 28 contact hours ) . Only the maxillary teeth were treated , and all bleaching was unsupervised . Whitening was measured objective ly by comparing digital images of the maxillary anterior dentition at pretreatment and posttreatment . Compared with baseline , both the strip and tray systems exhibited statistically significant decreases ( P < 0.05 ) in yellowness ( delta b * ) and increases in brightness ( delta L * ) . Compared with the tray-system group , the strip-system group experienced significant additional whitening ( P < 0.03 ) , as evidence d by a 62 % to 209 % improvement in tooth color ( delta b * , delta L * , and delta E * ) after 14 days . Both systems were generally well tolerated , and none of the subjects discontinued treatment early because of an adverse event . Under the conditions tested , this clinical trial demonstrates that the 14-contact-hour treatment with the strip system result ed in superior whitening efficacy compared with the 28-contact-hour treatment with the tray system This clinical study compared the efficacy of three different bleaching techniques with respect to the bleaching times required in order to achieve six grade s of whitening in human teeth . Any side effects that were noted and the patients ' acceptance of the method were recorded by a visual analog scale ranging from 0 to 10 . Moreover , epoxy casts from the study teeth were analyzed by scanning electron microscopy in order to detect any potential changes in the enamel surface due to treatments . Thirty-nine volunteers participated in the study and were allocated r and omly to one of three different bleaching treatments : Group A ( n=13 ) used Whitestrips ( over-the-counter technique ; one cycle=30 minutes ) , Group B ( n=13 ) used Opalescence PF 10 % ( at-home bleaching technique ; one cycle=8 hours ) and Group C ( n=13 ) used Opalescence Xtra Boost ( in-office bleaching technique ; one cycle=15 minutes ) until a defined whitening of six tabs compared to the baseline were reached ( assessed by the VITA shade guide ) . All three methods achieved six grade s of whitening . The mean treatment time required to reach the defined level of whitening was 31.85 + /- 6.63 cycles in Group A , 7.15 + /- 1.86 cycles in Group B and 3.15 + /- 0.55 cycles in Group C. All products differed significantly from each other in terms of treatment cycles and required treatment time ( p<0.001 by ANOVA and Mann-Whitney-U-test ) . Using the VA scale , side effects noted within the three groups were minimal . Tooth hypersensitivity ranged from 2.62 ( Whitestrips ) to 3.38 ( Opalescence PF ) , and gingival irritation ranged between 0.23 ( Opalescence Xtra Boost ) and 0.85 ( Whitestrips ) . The most accepted method was the at-home bleaching technique . None of the teeth studied showed detectable enamel surface changes in the subsequent SEM analysis using 200x and 2000x magnification This study tested the hypothesis that beveling and /or etching enamel does not affect the 6-month clinical performance of the self-etch adhesive Clearfil SE Bond in class V noncarious lesions . With Institutional Review Board approval , 34 patients were enrolled in this study . A total of 120 noncarious cervical lesions were selected and assigned to 4 groups : ( 1 ) Clearfil SE Bond was applied without any cavity preparation ; ( 2 ) After the enamel was beveled , Clearfil SE Bond was applied ; ( 3 ) After the enamel was etched for 15 seconds with 35 % phosphoric acid , Clearfil SE Bond was applied ; ( 4 ) After the enamel was beveled and etched with 35 % phosphoric acid for 15 seconds , Clearfil SE Bond was applied . A microfilled composite resin was used for all restorations . Six months after initial placement , 120 restorations ( a 100 % recall rate ) were re-evaluated . Retention rates at 6 months were 100 % for all groups . Sensitivity to air improved from baseline to 6 months , but the overall difference was not statistically significant . The 6-month retention rate of the self etch dentin adhesive system Clearfil SE Bond was not improved by enamel beveling or by enamel etching . For the self-etch material Clearfil SE Bond , instrumentation or etching of enamel may not be critical for its clinical performance at 6 months A r and omized and controlled , parallel-group clinical trial compared the whitening benefits of a novel 5.3 % hydrogen peroxide bleaching strip to 10 % , 15 % , and 20 % carbamide peroxide tray-based bleaching systems . A total of 36 healthy adults were r and omized to a 14-day regimen in which both arches were whitened for 1 hour per day in the whitening-strip group or 2 hours per day in the tray groups . Efficacy was measured objective ly using digital images of the anterior teeth at baseline and after 14 days of treatment . Overall tooth color ( L*a*b * ) was derived from individual pixel values , and then mean levels of delta b * , delta L * , and composite color ( delta E * ) were compared using analysis of covariance . After 14 days of treatment , all groups experienced a greater than 1-unit mean improvement in delta b * , delta L * , and delta E * relative to baseline . For the primary study variable , reduction of yellow ( delta b * ) outcomes after 14 hours of using the experimental strip were comparable to those observed with the 10 % tray group after 28 hours of use . These two treatment groups did not differ statistically with respect to any of the color measurements used in this study . For the tray groups , there was a reasonable dose relationship for the primary end point , delta b * , with the 15 % and 20 % tray groups averaging 17 % and 68 % improvements in yellow , respectively , over the 10 % group . Except for the 20 % carbamide peroxide system , where sensitivity was relatively common , all test products were well tolerated . In this first comparative evaluation vs marketed controls , use of the whitening strips twice daily for 14 days yielded a highly significant improvement in tooth color vs baseline This clinical trial tested the efficacy and safety of a professional strip-based whitening system ( Crest Whitestrips Supreme ) using the manufacturer 's recommended 3-week treatment regimen . These strips have a higher concentration , but a similar amount of hydrogen peroxide relative to Crest Professional Whitestrips , because the thickness of the gel on strips is reduced . Tooth whitening was measured using the value-oriented VITA Classic Shade Guide before and after treatment . Twenty-nine subjects were treated with either Crest Whitestrips Supreme or placebo strips that did not contain hydrogen peroxide . Participants in the experimental group achieved a mean lightening of nearly eight VITA shades relative to placebo , with minimal side effects A 2-week study was conducted to compare the tooth-whitening efficacy of two 10 % carbamide peroxide products : Colgate Platinum Professional Toothwhitening System and Rembr and t Lighten Bleaching Gel . Fifty subjects were divided into two groups and assigned a product to use for 2 weeks . Change in tooth color was measured by reflectance spectroscopy at the initiation of study , at 1 week , and at 2 weeks into the study . Color change was calculated using the color-difference equation established by the Commission International de L'Eclairage . Results showed that Colgate Platinum was 62 % more effective at tooth whitening after 1 week and 83 % more effective after 2 weeks of treatment vs Rembr and t. At the termination of the study , the mean color difference ( deltaE ) for Colgate Platinum was 4.29 and 2.34 for Rembr and t. Statistical analysis demonstrated that the Colgate product is significantly superior at increasing tooth whiteness , increasing tooth lightness , reducing redness , and reducing yellowness . In this study , no adverse reactions were noted on clinical examination and none were reported by panelists with normal healthy dentition PURPOSE To evaluate objective and subjective whitening responses of two marketed vital bleaching systems under intended use conditions . MATERIAL SA ND METHODS : The r and omized clinical trial evaluated 50 adults who received either a combination system with a 3 % hydrogen peroxide bleaching gel , pre-formed dual arch tray , dentifrice and oral rinse ( Rapid White ) , or 6 % hydrogen peroxide whitening strips ( Crest Whitestrips ) . Efficacy was assessed objective ly from L*a*b * tooth color at Days 7 & 14 , while subjective , first-person whitening perception was measured by question naire . A cumulative multinomial probability model was generated to predict subjective responses from objective ly measured tooth color . RESULTS At end-of-treatment , adjusted mean deltab * was -2.05 + /- 0.158 for the whitening strip group compared to -0.69 + /- 0.141 for the combination group , with these groups differing significantly ( P < 0.0001 ) . This response held across every color parameter and time point in this study . Relative to the combination system , subjects in the whitening strip group rated that product significantly ( P < 0.01 ) more favorably with respect to the amount of whiteness improvement , as well as whitening satisfaction and overall impression . These subjective responses were correlated with objective changes in to
Output:
| Mild ' to ' moderate ' tooth sensitivity and gingival irritation were the most common side effects .
The whitening strips and products with high concentrations of HP caused more users to complain from tooth sensitivity .
There is evidence that whitening products work when compared with placebo/no treatment .
There are differences in efficacy between the products , mainly due to the levels of active ingredients , hydrogen peroxide and carbamide peroxide . |
MS212426 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background The WelTel Kenya1 trial demonstrated that text message support improved adherence to antiretroviral therapy ( ART ) and suppression of HIV-1 RNA load . The intervention involved sending weekly messages to patients inquiring how they were doing ; participants were required to respond either that they were well or that there was a problem . Objectives 1 ) Describe problems participants identified through mobile phone support and reasons why participants did not respond to the messages ; 2 ) investigate factors associated with indicating a problem and not responding ; and 3 ) examine participant perceptions of the intervention . Design Secondary analysis of WelTel Kenya1 trial data . Methods Reasons participants indicated a problem or did not respond were extracted from the study log . Negative binomial regression was used to determine participant characteristics associated with indicating a problem and non-response . Data from follow-up question naires were used to describe participant perceptions of the intervention . Results Between 2007 and 2009 , 271 participants generated 11,873 responses ; 377 of which indicated a problem . Health issues were the primary reason for problem responses ( 72 % ) . Rural residence ( adjusted incidence rate ratio [ IRR ] 1.96 ; 95%CI 1.19–3.25 ; p = 0.009 and age were associated with indicating a problem ( adjusted IRR 0.63 per increase in age group category ; 95%CI 0.50–0.80 ; p<0.001 ) . Higher educational level was associated with a decreased rate of non-response ( adjusted IRR 0.81 ; 95%CI 0.69–0.94 ; p = 0.005 ) . Of participants interviewed , 62 % ( n = 129 ) stated there were no barriers to the intervention ; cell phone issues were the most common barrier . Benefits included reminding patients to take medication and promoting a feeling that “ someone cares ” . Conclusions The WelTel intervention enabled frequent communication between clinicians and patients during the WelTel Kenya1 trial . Many patients valued the service for the support it provided , with health-related concerns comprising the majority of problems identified by participants . Few sociodemographic characteristics were associated with participant engagement in the intervention Background The World Health Organization now recommends parasitological confirmation for malaria case management . Rapid diagnostic tests ( RDTs ) for malaria are an accurate and simple diagnostic to confirm parasite presence in blood . However , where they have been deployed , adherence to RDT results has been poor , especially when the test result is negative . Few studies have examined adherence to RDTs distributed or purchased through the private sector . Methods The Rapid Examination of Malaria and Evaluation of Diagnostic Information ( REMEDI ) study assessed the acceptability of and adherence to RDT results for patients seeking care from private sector drug retailers in two cities in Oyo State in south-west Nigeria . In total , 465 adult participants were enrolled upon exit from a participating drug shop having purchased anti-malaria drugs for themselves . Participants were given a free RDT and the appropriate treatment advice based on their RDT result . Short Message Service ( SMS ) text messages reiterating the treatment advice were sent to a r and omly selected half of the participants one day after being tested . Participants were contacted via phone four days after the RDT was conducted to assess adherence to the RDT information and treatment advice . Results Adherence to RDT results was 14.3 percentage points ( P-val < 0.001 ) higher in the treatment group who were sent the SMS . The higher adherence in the treatment group was robust to several specification tests and the estimated difference in adherence ranged from 9.7 to 16.1 percentage points . Further , the higher adherence to the treatment advice was specific to the treatment advice for anti-malarial drugs and not other drugs purchased to treat malaria symptoms in the RDT-negative participants who bought both anti-malarial and symptom drugs . There was no difference in adherence for the RDT-positive participants who were sent the SMS . Conclusions SMS text messages substantially increased adherence to RDT results for patients seeking care for malaria from privately owned drug retailers in Nigeria and may be a simple and cost-effective means for boosting adherence to RDT results if and when RDTs are introduced as a commercial retail product Background Low rates of adherence to artemisinin-based combination therapy ( ACT ) regimens increase the risk of treatment failure and may lead to drug resistance , threatening the sustainability of current anti-malarial efforts . We assessed the impact of text message reminders on adherence to ACT regimens . Methods Health workers at hospitals , clinics , pharmacies , and other stationary ACT distributors in Tamale , Ghana provided flyers advertising free mobile health information to individuals receiving malaria treatment . The messaging system automatically r and omized self-enrolled individuals to the control group or the treatment group with equal probability ; those in the treatment group were further r and omly assigned to receive a simple text message reminder or the simple reminder plus an additional statement about adherence in 12-hour intervals . The main outcome was self-reported adherence based on follow-up interviews occurring three days after treatment initiation . We estimated the impact of the messages on treatment completion using logistic regression . Results 1140 individuals enrolled in both the study and the text reminder system . Among individuals in the control group , 61.5 % took the full course of treatment . The simple text message reminders increased the odds of adherence ( adjusted OR 1.45 , 95 % CI [ 1.03 to 2.04 ] , p-value 0.028 ) . Receiving an additional message did not result in a significant change in adherence ( adjusted OR 0.77 , 95 % CI [ 0.50 to 1.20 ] , p-value 0.252 ) . Conclusion The results of this study suggest that a simple text message reminder can increase adherence to antimalarial treatment and that additional information included in messages does not have a significant impact on completion of ACT treatment . Further research is needed to develop the most effective text message content and frequency . Trial Registration Clinical Trials.gov This paper presents the results of a qualitative study to investigate the perceptions and experiences of health workers involved in a a cluster-r and omized controlled trial of a novel intervention to improve health worker malaria case-management in 107 government health facilities in Kenya . The intervention involved sending text-messages about paediatric outpatient malaria case-management accompanied by “ motivating ” quotes to health workers ’ mobile phones . Ten malaria messages were developed reflecting recommendations from the Kenyan national guidelines . Two messages were delivered per day for 5 working days and the process was repeated for 26 weeks ( May to October 2009 ) . The accompanying quotes were unique to each message . The intervention was delivered to 119 health workers and there were significant improvements in correct artemether-lumefantrine ( AL ) management both immediately after the intervention ( November 2009 ) and 6 months later ( May 2010 ) . In-depth interviews with 24 health workers were undertaken to investigate the possible drivers of this change . The results suggest high acceptance of all components of the intervention , with the active delivery of information in an on the job setting , the ready availability of new and stored text messages and the perception of being kept ‘ up to date ’ as important factors influencing practice . Applying the construct of stages of change we infer that in this intervention the SMS messages were operating primarily at the action and maintenance stages of behaviour change achieving their effect by creating an enabling environment and providing a prompt to action for the implementation of case management practice s that had already been accepted as the clinical norm by the health workers . Future trials testing the effectiveness of SMS reminders in creating an enabling environment for the establishment of new norms in clinical practice as well as in providing a prompt to action for the implementation of the new case-management guidelines are justified Objective : There is limited evidence on whether growing mobile phone availability in sub-Saharan Africa can be used to promote high adherence to antiretroviral therapy ( ART ) . This study tested the efficacy of short message service ( SMS ) reminders on adherence to ART among patients attending a rural clinic in Kenya . Design : A r and omized controlled trial of four SMS reminder interventions with 48 weeks of follow-up . Methods : Four hundred and thirty-one adult patients who had initiated ART within 3 months were enrolled and r and omly assigned to a control group or one of the four intervention groups . Participants in the intervention groups received SMS reminders that were either short or long and sent at a daily or weekly frequency . Adherence was measured using the medication event monitoring system . The primary outcome was whether adherence exceeded 90 % during each 12-week period of analysis and the 48-week study period . The secondary outcome was whether there were treatment interruptions lasting at least 48 h. Results : In intention-to-treat analysis , 53 % of participants receiving weekly SMS reminders achieved adherence of at least 90 % during the 48 weeks of the study , compared with 40 % of participants in the control group ( P = 0.03 ) . Participants in groups receiving weekly reminders were also significantly less likely to experience treatment interruptions exceeding 48 h during the 48-week follow-up period than participants in the control group ( 81 vs. 90 % , P = 0.03 ) . Conclusion : These results suggest that SMS reminders may be an important tool to achieve optimal treatment response in re source -limited setting INTRODUCTION We will be unable to achieve sustained impact on health outcomes with community health worker (CHW)-based interventions unless we bridge the gap between small scale efficacy studies and large scale interventions . Effective strategies to support the management of CHWs are central to bridging the gap . Mobile phones are broadly available , particularly in low and middle income countries ( LAMIC 's ) , where the penetration rate approaches 100 % . In this article we describe how mobile phones may be combined with mobile web-based technology to assist in the management of CHWs in two projects in South Africa . METHODS This paper is a descriptive one , drawing lessons from two R and omised Controlled Trials ( RCT ' s ) , outlining how a mobile phone information system can be utilized to enhance the quality of health interventions . We organized our comprehensive management and supervision system around a previously published management framework . The system is composed of mobile phones utilized by CHWs and a web-based interface utilized by CHW supervisors . Computerized algorithms were design ed with intervention and assessment protocol s to aid in the real-time supervision and management of CHWs . RESULTS CHWs used mobile phones to initiate intervention visits and trigger content to be delivered during the course of intervention visits . Supervisors used the web-based interface for real-time monitoring of the location , timing , and content of intervention visits . Additional real-time support was provided through direct support calls in the event of crises in the field . CONCLUSION Mobile phone-based information system platforms offer significant opportunities to improve CHW-delivered interventions . The extent to which these efficiency gains can be translated into realized health gains for communities is yet to be tested OBJECTIVE South Africa has one of the highest human immunodeficiency virus ( HIV ) prevalence rates in the world , but despite the well-established benefits of HIV counseling and testing ( HCT ) , there is low uptake of HCT . The study aim ed to investigate the effectiveness of using short message services ( SMSs ) to encourage HCT while interrogating the impact of altering SMS content and dosage ( the number of SMSs ) . MATERIAL S AND METHODS About 2,533 participants were recruited via an SMS sent to 24,000 mobiles r and omly sample d from a pre-existing data base . Recruits were r and omly allocated to four intervention groups that received 3 or 10 informational ( INFO ) or motivational ( MOTI ) SMSs , and a control group . After the intervention , participants were prompted to go for HCT , and postintervention assessment was done after 3 weeks . RESULTS In comparison with the control , receipt of 10 MOTI messages had the most impact on uptake of HCT with a 1.7-fold increased odds of testing ( confidence interval 95 % ; p=0.0036 ) . The lack of efficacy of three SMSs indicates a threshold effect , that is , a minimum number of MOTI SMSs is required . INFO SMSs , whether 3 or 10 were sent , did not have a statistically significant effect . The cost can be calculated for the marginal effect of the SMSs , that is , the cost to get people to test over and above those who were likely to test without the intervention . Use of 10 MOTI SMSs yielded a cost-per-tester of $ 2.41 . CONCLUSIONS While there are method ological issues apparent in our study , the results demonstrate the potential of SMSs to influence the uptake of HCT , the importance of appropriate content , and the need to determine a threshold for SMS-based interventions . These results indicate a potential for SMSs to be used more generally for interventions encouraging people to take health-related actions , and the need for further research in this field . The reasonable cost-per-tester is promising for the scale-up of such an intervention Background Effective use of proven treatments for high blood pressure , a preventable health risk , is challenging for many patients . Prompts via mobile phone SMS-text messaging may improve adherence to clinic visits and treatment , though more research is needed on impact and patient perceptions of such support interventions , especially in low-re source setting s. Method An individually-r and omised controlled trial in a primary care clinic in Cape Town ( 2012–14 ) , tested the effect of an adherence support intervention delivered via SMS-texts , on blood pressure control and adherence to medication , for hypertensive patients . ( Trial registration : Clinical Trials.gov NCT02019823 ) . We report on a qualitative evaluation that explored the trial participants ’ experiences and responses to the SMS-text messages , and identified barriers and facilitators to delivering adherence support via patients ’ own mobile phones . Two focus groups and fifteen individual interviews were conducted
Output:
| Results Review of these texts reveals ambivalence in the appraisal of mHealth ; essentially , the critical stance in general analyses/overviews is absent from project assessment s. Especially weak evidence concerning sustainability and scalability is stressed in overviews .
Project assessment s are more optimistic .
Their analysis suggests a causal connection between simplicity and success .
Effective interventions are thus characterized by straightforward design and modest objectives .
Greatest impediments of impact are general technology-related issues and intervention inappropriateness due to insufficient underst and ing of beneficiaries and specific context of use ( circumstantial complications ) .
Conclusion Distinguishing between these two categories of complications helps to break the deadlock that marks the mHealth debate and add nuance to cl aims that mHealth 's evidence base is weak . |
MS212427 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Concern about the survival of microorganisms in deep carious lesions may often lead to unnecessary exposure of the pulp during final excavation . There are reasons , therefore , to initiate systematic studies on the alternative procedure known as stepwise excavation . Clinical evaluation of stepwise excavation was performed on 31 deep carious lesions considered to result in pulp perforation by traditional excavation . This study examines the clinical and microbiological alterations during the final excavation performed during long intervals ( 6 - 12 months ) after the initial treatment that included peripheral dentine excavation and removal of the central cariogenic biomass and the superficial necrotic dentine . The dentine colour and consistency were assessed by means of st and ardized scales before application of a Ca(OH)2 compound and a temporary sealing for 6 - 12 months . Re assessment s were performed before the after final excavation . Microbiological dentine sample s were obtained in 19 r and omly selected lesions by a sterile bur , transferred to and diluted in reduced transport fluid , and plated on tryptic soy agar . After anaerobic incubation at 37 degrees C for 7 days , total colony-forming units per millilitre were counted from ( 1 ) peripheral excavated and hard dentine ( control ) , ( 2 ) central demineralized dentine before and final excavation , and ( 3 ) central dentine after the final excavation . Six sample s of central demineralized dentine were without any cultivable flora increasing to 9 sample s after the final excavation . The clinical dentine changes occurring during stepwise excavation were characterized by enhanced hardness of the dentine which was associated with a marked reduction in bacterial growth after the final excavation . Despite the presence of bacteria in the excavated dentine none of the carious lesions result ed in pulp perforation , suggesting that the initial removal of the cariogenic biomass appears to be essential for control of caries progression . Stepwise excavation is not only an appropriate treatment of deep carious lesions but is also considered a suitable model for microbiological studies to determine the bacteria persisting in clinical ly excavated lesions Objective This multicenter r and omized controlled clinical trial aim ed to compare the outcomes of stepwise excavation ( SW ) and partial caries removal ( PCR ) regarding the maintenance of pulp vitality in deep caries lesions over 5 years . Methods At baseline , 299 permanent molars with deep caries lesions were r and omly assigned to control or test groups . The control group received the stepwise excavation treatment ( SW ) , while the test group received partial caries removal from the pulpal wall followed by restoration in a single session ( PCR ) . Treatments were conducted in two centers located in the cities of Porto Alegre ( South Brazil ) and Brasília ( Midwest Brazil ) . Survival analysis was performed to compare PCR and SW over time ( Weibull regression models ) . The primary outcome of this study was pulp vitality , determined by the combination of the following characteristics : positive response to cold test , negative response to percussion , absence of spontaneous pain , and absence of periapical lesion ( radiographic examination ) . Results This 5-year study includes data pertaining to 229 teeth : 121 teeth actually examined at the 5-year appointment , and 108 teeth contributed with data collected in previous follow-ups ( 18 months or 3 years ) . Survival analysis showed success rates of 80 % in PCR group and 56 % in SW group ( p < 0.001 ) . Failure was significantly associated with treatment [ PCR , HR=0.38 ; 95%CI=0.23–0.63 ) ] and region [ South , HR=2.22 ; 95%CI=1.21–4.08 ] . Conclusion PCR significantly reduced the occurrence of pulp necrosis when compared with SW . Clinical relevance This study supports the PCR as a single-visit technique to manage deep caries lesions in permanent teeth OBJECTIVE To evaluate the clinical and radiographic outcomes ( 24 months ) of indirect pulp treatment ( IPT ) in primary teeth when a self-etching primer or a calcium hydroxide layer was used over the remaining carious dentin . STUDY DESIGN Primary molar teeth with deep carious lesions without signs and symptoms of irreversible pulpitis were divided into two groups , according to the capping material : Experimental group ( 1 ) : self-etching adhesive system ( Clearfill SE Bond ) ; and Control group ( 2 ) : calcium hydroxide liner ( Dycal ) . Both groups were followed up after application of a resin restoration ( 3 M - Z250 ) . RESULTS After 2 years of clinical and radiographic follow-up , no statistical difference was found between groups ( p = 1 ) . The overall success rate reached 87 % . CONCLUSION These results demonstrate that IPT has a high clinical and radiographic performance in primary teeth and is not dependent on the capping material used over the demineralized dentin PURPOSE The purpose of this study was to investigate dentin rehardening in the remaining carious dentin after indirect pulp treatment ( IPT ) using microhardness analysis after 37 to 71 months . METHODS Eighteen teeth su bmi tted to IPT and capped with calcium hydroxide ( CH ) or gutta-percha ( GP ) were evaluated ( treated group ) . Ten sound molars and 10 molars with deep acute carious lesions were selected to serve as positive and negative control groups , respectively . In the treated group , restorations and pulp-capping material s were removed . In the positive control group , 3- to 4-mm deep cavities were prepared . In the negative control group , the carious tissue was removed . Microhardness analysis was performed at 10- , 35- , 60- , 85- , and 110-microm depths . Data were analyzed using 1-way analysis of variance ( P<.05 ) . RESULTS Microhardness values for sound , carious , and treated groups at 10- , 35- , 60- , 85- , and 110-microm depths showed a statistically significant difference ( P < or=.01 ) among the groups for microhardness . No difference was observed between CH- and GP-treated groups for microhardness . CONCLUSION The results showed a hardness increase in treated teeth when compared to carious teeth in all dentin depths investigated , suggesting mineral gain after treatment PURPOSE The purpose of this study was to evaluate the effect of the material s used for indirect pulp treatment ( IPT ) on the long-term outcome of primary molar teeth . METHODS Forty-eight teeth with deep carious lesions , but without signs and symptoms of irreversible pulpitis , were r and omly divided into 2 groups , according to the material placed on the demineralized dentin remain : ( 1 ) experimental group , adhesive system ( Scotchbond Multi purpose ) ; and ( 2 ) control group , calcium hydroxide liner ( Dycal ) . Both groups were followed by a resin restoration application . RESULTS After 4 to 5 years , the clinical and radiographic success rates between groups were similar ( group 1=14 of 15 ; group 2=8 of 10 ; P=0.350 ) . Subsequent to exfoliation , scanning electron microscopy revealed the presence of a hybrid layer at the resin-dentin interface and a microtensile bond strength of 9.63 MPa ( group 1 ) . Histological analysis showed that the pulp health status was similar in both groups . CONCLUSIONS Indirect pulp treatment has a high clinical and radiographic long-term success rate in primary teeth and is not material -dependent PURPOSE The purpose of this prospect i ve and r and omized in vivo study was to compare the clinical and radiographic outcomes of an adhesive resin system vs a calcium hydroxide liner for protection of the dentin-pulp complex of primary molars treated with indirect pulp treatment . METHODS Forty-eight primary molars with deep occlusal caries , but without preoperative signs and symptoms of irreversible pulpitis , received indirect pulp treatment and were restored with a composite resin ( Z100 ) . The teeth were r and omly divided into 2 groups according to the material used for protection of the dentin-pulp complex : ( 1 ) adhesive resin system ( Scotchbond Multi Purpose ) ; and ( 2 ) calcium hydroxide liner ( Dycal ) . These teeth were evaluated clinical ly and radiographicaly for 2 years . RESULTS After 2 years , 83 % ( 19/23 ) of the teeth treated with calcium hydroxide and 96 % ( 24/25 ) of teeth treated with only the adhesive resin system presented a successful outcome , as determined by clinical and radiographic examination . Interradicular and /or periapical lesions were the most predominant signs of treatment failure , since 3 out of 23 teeth treated with calcium hydroxide and 1 out of 25 teeth treated with only adhesive resin presented this outcome . One tooth treated with the calcium hydroxide liner was diagnosed with internal root resorption at the 18-month examination . Of the 5 teeth diagnosed from radiographs as a failure of the indirect pulp treatment , none presented clinical signs/symptoms of pulpitis or necrosis such as the presence of fistula , enhanced tooth mobility , or pain . CONCLUSIONS This study demonstrates that protection of the dentin-pulp complex of primary molars with an adhesive resin system results in similar clinical and radiographic 2-year outcomes as compared to calcium hydroxide when indirect pulp treatment is performed in Class I composite restorations With the purpose of checking , in vivo , the effect of atraumatic restorative treatment ( ART ) on the remaining demineralized dentin , 12 primary molars with deep occlusal lesions from children with ages ranging from 3 to 7 were evaluated . After lesion excavation , and before glass ionomer cement placement , dentin sample s were collected from the pulpal wall of the cavity . After 3 months , the restorations were removed and new sample s were collected . Six micro areas of each sample were analyzed by X-ray energy dispersion spectrometer . Sample s obtained before treatment were infected and intertubular dentin had a loosely organized collagen matrix , with well-defined collagen fibers . Following treatment , in addition to a drastic reduction of the amount of bacteria , the intertubular dentin was denser , with more compact and closely packed collagen fibers . An increased calcium concentration was observed in dentin collected after treatment ( p < 0.001 ) , suggesting tissue remineralization , but fluoride was not detected . We conclude that ART allows a one-session approach , with the purpose of creating more favorable conditions for the healing process PURPOSE To evaluate the clinical and radiographic changes in primary teeth su bmi tted to indirect pulp treatment ( IPT ) over a 36-month period . METHODS Thirty-nine primary molars with deep caries , but without preoperative signs and symptoms of irreversible pulpits , received IPT . The teeth were r and omly divided into two groups , according to the material used for protection of the dentin-pulp complex : ( 1 ) a calcium hydroxide liner ( Hydro C ) and ( 2 ) a gutta-percha sheet . Both groups were restored with Z250 resin-based composite . RESULTS After 36 months , Group 1 showed a success rate of 73.3 % and Group 2 , 85.7 % . The overall success rate was 79.3 % , with no statistically significant difference between the groups ( P = 0.36 ) The aim of this r and omized , controlled , single-blind and prospect i ve study was to evaluate the clinical and radiographic success rates of three different bonding protocol s vs calcium hydroxide liner for protection of the dentin – pulp complex of primary molars with different remaining dentin thicknesses . Two hundred forty primary molar teeth with moderate to deep occlusal caries were restored in 97 children who met inclusion criteria . After cavity preparation , the teeth were r and omly assigned into four groups ( n = 60/group ) with respect to the material used for protection of the dentin – pulp complex : ( 1 ) total-etching with 36 % phosphoric acid followed by an acetone-based adhesive ( Prime&Bond NT ) , ( 2 ) a self-etch adhesive system ( Xeno III ) , ( 3 ) an acetone-based adhesive ( Prime&Bond NT ) without prior acid conditioning , and ( 4 ) control : calcium hydroxide cement ( Dycal ) . Teeth in groups 1–3 were restored with a polyacid-modified resin-based composite ( Dyract AP ) and those in group 4 with amalgam . The remaining dentin thickness was calculated using image analysis software ( ImageJ ) . The teeth were evaluated clinical ly and radiographically for 24 months . The distribution of restored teeth with minimal remaining dentin thickness ( ≤0.5 mm ) was 3.3 , 8.3 , 8.3 , and 10 % for groups 1 , 2 , 3 , and 4 , respectively . Despite the absence of pulpal protection in groups 1–3 , none of those teeth exhibited any significant clinical or radiographic symptom during the study period . After 2 years , the clinical and radiographic success rate of restorative treatments was 100 % . Protection of the dentin – pulp complex with the tested bonding protocol s result ed in similar outcomes in mainly shallow and medium deep cavities as compared to calcium hydroxide amalgam in more deep cavities , when indirect pulp treatment was performed in class I compomer restorations This r and omized , multicenter clinical trial evaluated the effectiveness of 2 treatments for deep caries lesions — partial caries removal ( PCR ) and stepwise excavation ( SW ) — with respect to the primary outcome of pulp vitality for a 3-year follow-up period . Inclusion criteria were as follows : patients with permanent molars presenting deep caries lesions ( lesion affecting ≥ 1/2 of the dentin on radiographic examination ) , positive response to
Output:
| The overall risk difference for CH versus adhesive system in primary teeth was 0.06 [ 95 % CI -0.01 to 0.13 ] , and the overall risk difference for CH versus GIC was 0.10 [ 95 % CI -0.01 to 0.22 ] , with no significant differences between material s. CH liner did not influence the clinical success of treatment for deep caries lesions of primary or permanent teeth . |
MS212428 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND S/ AIMS We evaluated the effect of antiviral therapy on fibrosis progression in patients with histological features of mild/moderate HCV disease recurrence defined by a Grading score≥4 and Staging score up to 3 ( Ishak ) at 1 year after liver transplantation . METHODS Seventy-three consecutive patients with mild/moderate recurrence were r and omized either to no treatment or to receive Pegilated-Interferon-alfa-2b and ribavirin for 52 weeks . Liver biopsies obtained at baseline ( 1 year after transplantation ) and 2 years afterwards were evaluated for assessment of disease progression , defined as worsening of at least 2 staging points or progression to stage 4 or higher . RESULTS As for these two major histological end points there were no statistically significant differences between the 2 groups ( 36.1 % vs. 50 % , p=0.34 and 36.1 % vs. 38.9 % , p=1 ) . Fifteen treated patients ( 41 % ) achieved a sustained virological response which was associated with a reduced risk of fibrosis worsening for both endpoints when compared to viremic patients ( p=0.04 ) . CONCLUSIONS Although antiviral-therapy was beneficial in preventing fibrosis progression in patients achieving a sustained virological response , the majority of the overall population of our patients with mild-moderate disease recurrence could not benefit from antiviral therapy either because they either could not be treated or did not respond to treatment ( EudraCT number : 2005 - 005760 ) Background . In this article , we explore the virological response to two types of interferon based treatment in recurrent hepatitis C virus in liver recipients who received thymoglobulin induction . Methods . Fifty consecutive patients were r and omized to receive PEG interferon alpha 2b ( 1.0 & mgr;g/kg per week ) , ribavirin ( 800 mg/d ) plus amantadine ( 200 mg/d ) , or PEG interferon alpha 2b ( 1.0 & mgr;g/kg per week ) plus ribavirin ( 800 mg/d ) . The primary endpoint was absence of hepatitis C virus RNA 6 months posttreatment . The secondary endpoint was change in fibrosis at 1 year . Results . Only 30 patients completed 1 year of treatment . In an intention to treat analysis , the sustained virological response ( SVR ) rate was 26 % in I/R/A group and 50 % in I/R group . By per protocol , the overall SVR rate was 57 % . Fibrosis progression by at least one stage was noted in 37 % patients . Twenty-nine percent of patients who achieved SVR had shown fibrosis progression by at least one stage whereas 46 % nonresponders showed fibrosis progression ( P = NS ) . Conclusion . This is the first study exploring the efficacy of pegylated interferon-based antiviral treatment in patients who received a steroid-free protocol . Our data is encouraging and shows that if liver transplant recipients can tolerate treatment for 1 year there is a reasonable chance of SVR OBJECTIVES To analyze sources search ed in Cochrane review s , to determine the proportion of trials included in review s that are indexed in major data bases , and to compare the quality of these trials with those from other sources . METHODS All new systematic review s in the Cochrane Library , Issue1 2001 , that were restricted to r and omized controlled trials ( RCTs ) or quasi- RCTs were selected . The sources search ed in the review s were recorded , and the trials included were checked to see whether they were indexed in four major data bases . Trials not indexed were checked to determine how they could be identified . The quality of trials found in major data bases was compared with those found from other sources . RESULTS The range in the number of data bases search ed per review ranged between one and twenty-seven . The proportion of the trials in the four data bases were Cochrane Controlled Trials Register = 78.5 % , MEDLINE = 68.8 % , Embase = 65.0 % , and Science/Social Sciences Citation Index = 60.7 % . Search ing another twenty-six data bases after Cochrane Controlled Trials Register ( CCTR ) , MEDLINE , and Embase only found 2.4 % additional trials . There was no significant difference between trials found in the CCTR , MEDLINE , and Embase compared with other trials , with respect to adequate allocation concealment or sample size . CONCLUSIONS There was a large variation between review s in the exhaustiveness of the literature search es . CCTR was the single best source of RCTs . Additional data base search ing retrieved only a small percentage of extra trials . Contacting authors and manufacturers to find unpublished trials appeared to be a more effective method of obtaining the additional better quality trials The aim of the study was to observe the frequency of neutropenia during Pegylated Interferon/Ribavirin therapy in patient with chronic hepatitis C ; to compare the efficacy of two strategies of management of neutropenia -- with Interferon dose modification and with Neupogen administration ; to compare the effectiveness rate of sustained viral response ( SVR ) in patients with Pegylated Interferon dose modification and in patients treated by using granulocyte colony-stimulating factor G-CSF-filgrastim . ( Neupogen ) . Study enrolled 47 patients with chronic active hepatitis C , aged 23 - 64 . ( 38 male and 9 female ) . All patients had HCV genotype 1b . Significant neurtopenia ( ANC<750 mm3 ) and severe neurtopenia ( ANC<500 mm3 ) developed in 41 of 47 patients ( 87 % ) . 41 patients with neurtopenia were r and omized into two groups . The first group--22 patients who received granulocyte colony-stimulating factor ( G-CSF , or filgrastim ) 300 mcg s/c weekly for correction of neutropenia and the second group--19 patients treated either with Interferon dose reduction or temporarily inhibit of Interferon treatment . In all 22 patients of the first group neutropenia was normalized without reduction and /or inhibit of Pegylated interferon . Neupogen was well tolerated and in all 22 patients the improvement of quality of life ( QOL ) was observed . It was concluded that dose reduction or temporary inhibit of Pegylated Interferon in the second group negatively acts on antiviral treatment response in patients with HCV genotype 1 . In patients with PEG-IFN/RBV therapy Neupogen effectively manages neutropenia and gives opportunity to maintain interferon dose ( without reduction ) . Neupogen has the potential to improve adherence rates , which may in turn improve SVR Ischemic preconditioning ( IPC ) has the potential to decrease graft injury and morbidity after liver transplantation . We prospect ively investigated the safety and efficacy of 5 minutes of IPC induced by hilar clamping in local deceased donor livers r and omized 1:1 to st and ard ( STD ) recovery ( N = 28 ) or IPC ( N = 34 ) . Safety was assessed by measurement of heart rate , blood pressure , and visual inspection of abdominal organs during recovery , and efficacy by recipient aminotransferases ( aspartate aminotransferase [ AST ] and alanine aminotransferase [ ALT ] , both measured in U/L ) , total bilirubin , and international normalized ratio of prothrombin time ( INR ) after transplantation . IPC performed soon after laparotomy did not cause hemodynamic instability or visceral congestion . Recipient median AST , median ALT , and mean INR , in STD vs. IPC were as follows : day 1 AST 696 vs. 841 U/L ; day 3 AST 183 vs. 183 U/L ; day 1 ALT 444 vs. 764 U/L ; day 3 ALT 421 vs. 463 U/L ; day 1 INR 1.7 + /- .4 vs. 2.0 + /- .8 ; and day 3 INR 1.3 + /- .2 vs. 1.4 + /- .3 ; all P > .05 . No instances of nonfunction occurred . The 6-month graft and patient survival STD vs. IPC were 82 vs. 91 % and median hospital stay was 10 vs. 8 days ; both P > .05 . In conclusion , deceased donor livers tolerated 5 minutes of hilar clamping well , but IPC did not decrease graft injury . Further trials with longer periods of preconditioning such as 10 minutes are needed BACKGROUND & AIMS Recurrence of hepatitis C virus ( HCV ) infection is a relevant problem of liver transplantation programs . We evaluated the effect of antiviral therapy on disease progression in 81 HCV-infected liver transplantation recipients . METHODS Patients with mild hepatitis C recurrence ( fibrosis stage F0 to F2 , n = 54 ) were r and omized to no treatment ( group A , n = 27 ) or peginterferon alfa-2b/ribavirin for 48 weeks ( group B , n = 27 ) . Patients with severe recurrence ( F3 to F4 , cholestatic hepatitis ) were treated ( group C , n = 27 ) . All patients ( n = 81 ) underwent a liver biopsy at baseline and after follow-up ; paired hepatic venous pressure gradient ( HVPG ) measurements were available in 51 patients . RESULTS Thirteen ( 48 % ) patients of group B and 5 ( 18.5 % ) of group C achieved sustained virological response . Liver fibrosis progressed > or = 1 stage in 40 ( 49 % ) of 81 patients : 19 ( 70 % ) of group A versus 7 ( 26 % ) of group B ( P = .001 ) and in 14 ( 54 % ) of group C. HVPG increased ( 6.5 to 13 mm Hg , P < .01 ) in patients in whom fibrosis worsened , whereas it decreased ( 5 to 3.5 mm Hg , P = .017 ) or remained unchanged in those with fibrosis improvement or stabilization , respectively . The only variable independently associated with fibrosis improvement/stabilization was treatment ( odds ratio [ OR ] = 3.7 , 95 % confidence interval [ CI ] 1.3 to 10 , P = .009 ) . Among treated patients , alanine aminotransferase ( ALT ) normalization and viral clearance were independently associated with histological or hemodynamic improvement/stabilization ( OR 5.3 , 95 % CI 1.5 to 18 , P < .01 ; OR 7.4 , 95 % CI 1.4 to 38 , P = .01 ; respectively ) . CONCLUSIONS Our data demonstrate that in liver transplantation recipients , antiviral therapy slows disease progression ( particularly in sustained virological responders ) , as shown by its effects on liver histology and on HVPG Allograft reinfection with hepatitis C virus ( HCV ) in transplant recipients occurs commonly and represents a major concern in the transplant setting . Suppression of viral replication in HCV transplant patients should prevent or delay progression to cirrhosis and graft failure . In this ongoing study , we present preliminary data from a prospect i ve trial of st and ard interferon ( IFN ) alpha-2b ( 2 million units daily ) for 3 months and subsequent peginterferon ( PEG IFN ) alpha-2b ( 1.5 microg/kg/week ) for 9 months . IFN therapy was combined with ribavirin ( 10 to 12 mg/kg ) . So far , HCV has become undetectable by qualitative PCR in 33 % of patients while 25 % had a reduction of HCV RNA to undetectable by the bDNA assay and 42 % had no virological response after 6 months of therapy . A biochemical response was detected in 42 % of patients . Improvement of inflammatory activity was observed in 42 % of patients after 6 months . In three patients anemia necessitated administration of erythropoietin and three patients received granulocyte-colony stimulating factor ( G-CSF ) due to leucopenia [ corrected ] In conclusion , we observed that daily IFN alpha-2b and subsequent PEG IFN alpha-2b therapy in combination with ribavirin provides biochemical and virological benefits in transplant recipients with established recurrent HCV infection BACKGROUND / AIMS HCV infection recurs almost in all HCV-positive patients receiving liver transplantation and carries a poor prognosis . Aim of this study was to analyze efficacy and effect on survival of antiviral therapy in this clinical setting . METHODS Pegylated-interferon alpha-2b and ribavirin were administered at a dose of 1 microg/kg of bwt weekly and 600 - 800 mg/day . Planned duration of treatment was 24 or 48 weeks according to HCV genotype . Patients who failed to respond at week 24 were considered as non-responders . RESULTS 61 patients were enrolled . According to intention-to-treat analysis , 44 ( 72 % ) patients were considered as treatment failure ( 31 non-responders , 4 relapsers , 9 dropout ) . Sustained virological response was achieved in 17 cases ( 28 % ) . Genotype 2 , higher doses of antivirals and absence of histological cirrhosis were predictors of sustained virological response . In the follow up , patients with sustained virological response had a significantly lower mortality
Output:
| Considering the lack of clinical benefit , there is currently no evidence to recommend or refute antiviral treatment for recurrent liver graft infection with hepatitis C virus . |
MS212429 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Background It is increasingly acknowledged that ‘ acceptability ’ should be considered when design ing , evaluating and implementing healthcare interventions . However , the published literature offers little guidance on how to define or assess acceptability . The purpose of this study was to develop a multi-construct theoretical framework of acceptability of healthcare interventions that can be applied to assess prospect i ve ( i.e. anticipated ) and retrospective ( i.e. experienced ) acceptability from the perspective of intervention delivers and recipients . Methods Two methods were used to select the component constructs of acceptability . 1 ) An overview of review s was conducted to identify systematic review s that cl aim to define , theorise or measure acceptability of healthcare interventions . 2 ) Principles of inductive and deductive reasoning were applied to theorise the concept of acceptability and develop a theoretical framework . Steps included ( 1 ) defining acceptability ; ( 2 ) describing its properties and scope and ( 3 ) identifying component constructs and empirical indicators . Results From the 43 review s included in the overview , none explicitly theorised or defined acceptability . Measures used to assess acceptability focused on behaviour ( e.g. dropout rates ) ( 23 review s ) , affect ( i.e. feelings ) ( 5 review s ) , cognition ( i.e. perceptions ) ( 7 review s ) or a combination of these ( 8 review s).From the methods described above we propose a definition : Acceptability is a multi-faceted construct that reflects the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate , based on anticipated or experienced cognitive and emotional responses to the intervention . The theoretical framework of acceptability ( TFA ) consists of seven component constructs : affective attitude , burden , perceived effectiveness , ethicality , intervention coherence , opportunity costs , and self-efficacy . Conclusion Despite frequent cl aims that healthcare interventions have assessed acceptability , it is evident that acceptability research could be more robust . The proposed definition of acceptability and the TFA can inform assessment tools and evaluations of the acceptability of new or existing interventions OBJECTIVE This study examines hospital motivations to acquire new medical technology , an issue of considerable policy relevance : in this case , whether , when , and why hospitals acquire a new capital-intensive medical technology , magnetic resonance imaging equipment ( MRI ) . STUDY DESIGN We review three common explanations for medical technology adoption : profit maximization , technological preeminence , and clinical excellence , and incorporate them into a composite model , controlling for regulatory differences , market structures , and organizational characteristics . All four models are then tested using Cox regressions . DATA SOURCES The study is based on an initial sample of 637 hospitals in the continental United States that owned or leased an MRI unit as of 31 December 1988 , plus nonadopters . Due to missing data the final sample consisted of 507 hospitals . The data , drawn from two telephone surveys , are supplemented by the AHA Survey , census data , and industry and academic sources . PRINCIPAL FINDING Statistically , the three individual models account for roughly comparable amounts of variance in past adoption behavior . On the basis of explanatory power and parsimony , however , the technology model is " best . " Although the composite model is statistically better than any of the individual models , it does not add much more explanatory power adjusting for the number of variables added . CONCLUSIONS The composite model identified the importance a hospital attached to being a technological leader , its clinical requirements , and the change in revenues it associated with the adoption of MRI as the major determinants of adoption behavior . We conclude that a hospital 's adoption behavior is strongly linked to its strategic orientation Incomplete and inadequate reporting is an avoidable waste that reduces the usefulness of research . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement is an evidence -based reporting guideline that aims to improve research transparency and reduce waste . In 2008 , the CONSORT Group developed an extension to the original statement that addressed method ological issues specific to trials of nonpharmacologic treatments ( NPTs ) , such as surgery , rehabilitation , or psychotherapy . This article describes an up date of that extension and presents an extension for reporting abstract s of NPT trials . To develop these material s , the authors review ed pertinent literature published up to July 2016 ; surveyed authors of NPT trials ; and conducted a consensus meeting with editors , trialists , and method ologists . Changes to the CONSORT Statement extension for NPT trials include wording modifications to improve readers ' underst and ing and the addition of 3 new items . These items address whether and how adherence of participants to interventions is assessed or enhanced , description of attempts to limit bias if blinding is not possible , and specification of the delay between r and omization and initiation of the intervention . The CONSORT extension for abstract s of NPT trials includes 2 new items that were not specified in the original CONSORT Statement for abstract s. The first addresses reporting of eligibility criteria for centers where the intervention is performed and for care providers . The second addresses reporting of important changes to the intervention versus what was planned . Both the up date d CONSORT extension for NPT trials and the CONSORT extension for NPT trial abstract s should help authors , editors , and peer review ers improve the transparency of NPT trial reports
Output:
| Twenty-nine studies of interventions aim ed at improving clinician-patient communication in clinical setting s. We identified acceptability , adoption , appropriateness , feasibility , fidelity , implementation cost , intervention complexity , penetration , reach , and sustainability as factors that are feasible and appropriate to extract during an evidence synthesis project .
Abstract ing information about these factors may enhance the value of systematic review s and other evidence synthesis efforts , improving the dissemination and adoption of interventions that are effective , feasible , and sustainable across different context |
MS212430 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Background Human re source limitations are a challenge to the delivery of antiretroviral therapy ( ART ) in low-re source setting s. We conducted a cluster r and omized trial to assess the effect of community-based peer health workers ( PHW ) on AIDS care of adults in Rakai , Ug and a. Methodology /Principal Findings 15 AIDS clinics were r and omized 2∶1 to receive the PHW intervention ( n = 10 ) or control ( n = 5 ) . PHW tasks included clinic and home-based provision of counseling , clinical , adherence to ART , and social support . Primary outcomes were adherence and cumulative risk of virologic failure ( > 400 copies/mL ) . Secondary outcomes were virologic failure at each 24 week time point up to 192 weeks of ART . Analysis was by intention to treat . From May 2006 to July 2008 , 1336 patients were followed . 444 ( 33 % ) of these patients were already on ART at the start of the study . No significant differences were found in lack of adherence ( < 95 % pill count adherence risk ratio [ RR ] 0.55 , 95 % confidence interval [ CI ] 0.23–1.35 ; < 100 % adherence RR 1.10 , 95 % CI 0.94–1.30 ) , cumulative risk of virologic failure ( RR 0.81 , 95 % CI 0.61–1.08 ) or in shorter-term virologic outcomes ( 24 week virologic failure RR 0.93 , 95 % CI 0.65–1.32 ; 48 week , RR 0.83 , 95 % CI 0.47–1.48 ; 72 week , RR 0.81 , 95 % CI 0.44–1.49 ) . However , virologic failure rates ≥96 weeks into ART were significantly decreased in the intervention arm compared to the control arm ( 96 week failure RR 0.50 , 95 % CI 0.31–0.81 ; 120 week , RR 0.59 , 95 % CI 0.22–1.60 ; 144 week , RR 0.39 , 95 % CI 0.16–0.95 ; 168 week , RR 0.30 , 95 % CI 0.097–0.92 ; 192 week , RR 0.067 , 95 % CI 0.0065–0.71 ) . Conclusions / Significance A PHW intervention was associated with decreased virologic failure rates occurring 96 weeks and longer into ART , but did not affect cumulative risk of virologic failure , adherence measures , or shorter-term virologic outcomes . PHWs may be an effective intervention to sustain long-term ART in low-re source setting s. Trial Registration Clinical Trials.gov Background : We prospect ively studied the impact of an adherence counselor on the outcome of patients failing antiretroviral therapy because of nonadherence . Methods : Forty-six patients , identified as chronically nonadherent were enrolled . Individual attention was provided using the information , motivation and behavioral methodology . HIV RNA ( viral load , in copies/mL ) , CD4 count ( in cells/mm 3 ) , and body weight before and after the adherence counselor were measured . Qualitative outcome and patient satisfaction were assessed by deidentified third-party interviews . Results : Over half completed at least 1 year ; only 8 patients were lost to follow-up . Mean CD4 counts increased significantly ( P < .05 ) for completers at 6 and 12 months . Viral loads decreased between baseline and 6 months . Most clients reported subjective benefit from working with the adherence counselor . Conclusion : Although few clients showed complete virologic suppression , the value of an adherence counselor was vali date d. Longer term adherence programs should be evaluated Objective : To determine the efficacy of patient-selected treatment partners on virologic and adherence outcomes during first-line antiretroviral therapy . Design : R and omized controlled trial . Setting and Analytical Approach : Between June 2006 and December 2007 , 499 HIV-infected adults in Jos , Nigeria , were r and omized to st and ard of care ( SOC ) or patient-selected treatment partner-assisted therapy ( TPA ) . Each patient was followed for 48 weeks . Virologic outcomes , adherence to drug pick-up , CD4 cell counts , and mortality are reported . Results : At week 24 , undetectable viral load was achieved by 61.7 % of patients in the TPA arm versus 50.2 % of those receiving SOC [ odds ratio ( OR ) = 1.58 , 95 % CI : 1.11 to 2.26 , P < 0.05 ] . There was no significant difference at week 48 : 65.3 % versus 59.4 % for TPA and SOC , respectively ( OR = 1.28 , 95 % CI : 0.89 to 1.84 , P > 0.05 ) . The TPA group had more than 3 times the odds of at least 95 % drug pickup adherence through week 24 ( OR = 3.06 , 95 % CI : 1.89 to 4.94 , P < 0.01 ) and almost twice the odds through week 48 ( OR = 1.95 , 95 % CI : 1.29 to 2.93 , P < 0.01 ) . At week 48 , there were no significant differences in CD4 cell count increases ( t = −0.09 , df = 404 , P > 0.05 ) or mortality ( 10.6 % vs. 6.1 % ) between TPA vs. SOC , respectively . Residence-to-clinic distance was significantly associated with virologic and adherence outcomes . Conclusions : Use of patient-selected treatment partners was associated with improved drug pickup adherence and initial virologic success but had no durable effect on attaining undetectable viral load A r and omized 2-group medication adherence intervention is evaluated with HIV-infected adults ( N = 141 ) assessed at baseline , 3- , and 9-month follow-ups . Cognitive ( self-efficacy , behavioral intent ) , mental health ( depression , well-being ) , and substance use indicators were the outcome measures . In addition , a posttest-only analysis from 3 to 9 months evaluates intervention impact on antiretroviral adherence , measured through Medication Event Monitoring System and pill counts . Compared to the st and ard care group , the intervention group showed significant increases in adherence self-efficacy and behavioral intent at 3 and 9 months and marginal improvements in mental health . Although the st and ard care group had higher adherence at 3 months ( no baseline data were available prior to intervention ) , intervention group patients showed significant increases in adherence from 3 to 9 months . Although adherence levels achieved by intervention patients may not be sufficient for virological control , this is one of the first studies to provide promising results of longer term effectiveness of a behavioral adherence intervention Context Highly active antiretroviral therapy ( HAART ) improves outcomes in HIV-infected patients . When is the best time to start this therapy ? Contribution 1422 HIV-infected adults were followed for 2 to 6 years after starting HAART . Adherent patients who started treatment with lower ( 0.200 to 0.349 109 cells/L ) and higher ( 0.350 109 cells/L ) CD4 + cell counts had statistically similar mortality rates . Nonadherent patients had higher mortality rates than adherent patients , regardless of baseline CD4 + cell count of 0.200 to 0.349 109 cells/L or 0.350 109 cells/L or greater . Implication s In HIV-infected patients , adherence , rather than when therapy is initiated before a CD4 + cell count of 0.200 109 cells/L , may be the most important determinant of survival . The Editors The benefits of highly active antiretroviral therapy ( HAART ) in the management of HIV disease are well established . By suppressing plasma HIV-1 RNA , HAART decreases morbidity and mortality in HIV-infected patients ( 1 , 2 ) . However , the optimal time to initiate HAART is uncertain . As a result , expert recommendations on the optimal time to initiate antiretroviral therapy widely differ ( 3 - 6 ) . Several studies have suggested that only patients who initiated therapy when the CD4 + cell count had declined below 0.200 109 cells/L were at increased risk for disease progression , regardless of the baseline HIV RNA level ( 7 - 9 ) . In 1 of these studies , further examination with additional duration of follow-up suggested that mortality may be elevated in patients who initiated therapy after the CD4 + cell count declined below 0.350 109 cells/L ( 10 ) . In fact , a growing number of studies have suggested that delaying HAART after the CD4 + cell count declines below 0.350 109 cells/L may be unsafe ( 11 - 14 ) . However , previous studies ( 7 , 9 , 11 - 14 ) did not adjust for patient adherence . This limitation is critically important because incomplete adherence is associated with increased mortality ( 15 - 17 ) . Therefore , we sought to evaluate the effect of baseline CD4 + cell count and adherence on survival rates after the initiation of HAART . Methods The HAART Observational Medical Evaluation and Research ( HOMER ) study , conducted through the British Columbia Centre for Excellence in HIV/AIDS Drug Treatment Program , has been described in detail elsewhere ( 7 , 17 ) . Briefly , the Centre is the only free source of antiretroviral medications in British Columbia , Canada ; pharmaceutical sales suggest that less than 1 % of HIV-infected patients in this province obtain antiretroviral agents outside the program ( 18 ) . For all participants , the program maintains a complete prospect i ve profile of antiretroviral therapy . In the present study , we restricted analyses to HIV-infected men and women who had been antiretroviral naive until triple-drug antiretroviral therapy was prescribed between 1 August 1996 and 31 July 2000 and were followed through 31 March 2002 . Study participants were initially prescribed HAART regimens that included 2 nucleoside reverse transcriptase inhibitors and either a protease inhibitor or a nonnucleoside reverse transcriptase inhibitor ( the enrolling physician , in consultation with the patient , chose the regimen ) . End Points The primary end point in this analysis was time to death . Deaths occurring during the follow-up period were continuously identified from physician reports and through record linkages with the British Columbia Division of Vital Statistics . In the primary analysis , we evaluated all-cause mortality ; in subanalyses , we censored deaths from accidental causes at the time of death and classified them as nonevents ( 7 ) . Statistical Analysis KaplanMeier Analyses For the KaplanMeier analyses , we stratified patients into 5 baseline CD4 + cell count strata on the basis of previous studies and the recommendations of therapeutic guidelines : less than 0.200 , 0.200 to 0.249 , 0.250 to 0.299 , 0.300 to 0.349 , and greater than or equal to 0.350 109 cells/L ( 3 - 5 , 7 - 9 ) . We further stratified patients into adherent and nonadherent categories according to adherence to prescription refills ( 19 ) . The definition of adherence was based on the ratio of time that medication dispensed would last as a proportion of follow-up time . This calculation was restricted to each patient 's first year of therapy in order to limit the potential for reverse causation in patients who ceased antiretroviral therapy after they became too sick to take medication ( 15 , 20 ) . We have previously demonstrated that adherence defined in this way strongly predicts virologic response and mortality and that it can be used to adjust for the potentially confounding effect of treatment interruption ( 15 , 17 , 21 , 22 ) . In the primary analysis , we wanted to evaluate how moderate adherence to HAART affected survival . Therefore , to estimate the effect of moderate adherence , a priori we categorized patients as nonadherent only if they received antiretroviral medications less than 75 % of the time during the first year of therapy ( 15 , 17 ) . In a sub analysis , we estimated the risk for death from HIV disease among patients who were highly adherent to HAART . We defined adherence more rigorously for this analysis ; patients were considered nonadherent only if they received antiretroviral medications less than 95 % of the time during the first year of therapy ( 21 , 23 ) . We also censored deaths from accidental causes at the time of death and classified them as nonevents ( 7 ) . For both analyses , we evaluated the cumulative mortality rates among the predefined baseline CD4 + cell count strata using KaplanMeier methods . Survival curves were compared by using the log-rank test . Cox Regression Analyses We were aware that additional confounding may persist if the distribution of baseline AIDS diagnoses or baseline HIV RNA levels differed between patients with various bas
Output:
| Despite study diversity and limitations , evidence suggests that treatment supporters , directly observed therapy , mobile-phone text messages , diary cards , and food rations can effectively increase adherence in sub-Saharan Africa . |
MS212431 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND We present the combined results of two trials that compared adjuvant chemotherapy with or without concurrent trastuzumab in women with surgically removed HER2-positive breast cancer . METHODS The National Surgical Adjuvant Breast and Bowel Project trial B-31 compared doxorubicin and cyclophosphamide followed by paclitaxel every 3 weeks ( group 1 ) with the same regimen plus 52 weeks of trastuzumab beginning with the first dose of paclitaxel ( group 2 ) . The North Central Cancer Treatment Group trial N9831 compared three regimens : doxorubicin and cyclophosphamide followed by weekly paclitaxel ( group A ) , the same regimen followed by 52 weeks of trastuzumab after paclitaxel ( group B ) , and the same regimen plus 52 weeks of trastuzumab initiated concomitantly with paclitaxel ( group C ) . The studies were amended to include a joint analysis comparing groups 1 and A ( the control group ) with groups 2 and C ( the trastuzumab group ) . Group B was excluded because trastuzumab was not given concurrently with paclitaxel . RESULTS By March 15 , 2005 , 394 events ( recurrent , second primary cancer , or death before recurrence ) had been reported , triggering the first scheduled interim analysis . Of these , 133 were in the trastuzumab group and 261 in the control group ( hazard ratio , 0.48 ; P<0.0001 ) . This result crossed the early stopping boundary . The absolute difference in disease-free survival between the trastuzumab group and the control group was 12 percent at three years . Trastuzumab therapy was associated with a 33 percent reduction in the risk of death ( P=0.015 ) . The three-year cumulative incidence of class III or IV congestive heart failure or death from cardiac causes in the trastuzumab group was 4.1 percent in trial B-31 and 2.9 percent in trial N9831 . CONCLUSIONS Trastuzumab combined with paclitaxel after doxorubicin and cyclophosphamide improves outcomes among women with surgically removed HER2-positive breast cancer . ( Clinical Trials.gov numbers , NCT00004067 and NCT00005970 . Purpose : To assess pathologic complete response ( pCR ) , clinical response , feasibility , safety , and potential predictors of response to preoperative trastuzumab plus vinorelbine in patients with operable , human epidermal growth factor receptor 2 (HER2)–positive breast cancer . Experimental Design : Forty-eight patients received preoperative trastuzumab and vinorelbine weekly for 12 weeks . Single and multigene biomarker studies were done in an attempt to identify predictors of response . Results : Eight of 40 ( 20 % ) patients achieved pCR ( 95 % confidence interval , 9 - 36 % ) . Of 9 additional patients recruited for protocol -defined toxicity analysis , 8 were evaluable ; 42 of 48 ( 88 % ) patients had clinical response ( 16 patients , clinical complete response ; 26 patients , clinical partial response ) . T1 tumors more frequently exhibited clinical complete response ( P = 0.05 ) and showed a trend to exhibit pCR ( P = 0.07 ) . Five ( 13 % ) patients experienced grade 1 cardiac dysfunction during preoperative treatment . Neither HER2 nor estrogen receptor status changed significantly after exposure to trastuzumab and vinorelbine . RNA profiling identified three top-level clusters by unsupervised analysis . Tumors with extremes of response [ pCR ( n = 3 ) versus nonresponse ( n = 3 ) ] fell into separate groups by hierarchical clustering . No predictive genes were identified in pCR tumors . Nonresponding tumors were more likely to be T4 stage ( P = 0.02 ) and express basal markers ( P < 0.00001 ) , growth factors , and growth factor receptors . Insulin-like growth factor-I receptor membrane expression was associated with a lower response rate ( 50 % versus 97 % ; P = 0.001 ) . Conclusions : Preoperative trastuzumab plus vinorelbine is active and well tolerated in patients with HER2-positive , operable , stage II/III breast cancer . HER2-overexpressing tumors with a basal-like phenotype , or with expression of insulin-like growth factor-I receptor and other proteins involved in growth factor pathways , are more likely to be resistant to this regimen BACKGROUND It is unknown how a very high tumor total HER2 ( human epidermal growth factor receptor-2 ) content ( H2 T ) influences outcome in early breast cancer treated with adjuvant trastuzumab plus chemotherapy . PATIENTS AND METHODS H2 T was measured using a novel quantitative assay ( HERmark ( ® ) ) from formalin-fixed tumor tissue of 899 women who participated in the FinHer trial ( IS RCT N76560285 ) . In a chromogenic in situ hybridization ( CISH ) test , 197 ( 21.9 % ) patients had HER2-positive cancer and were r and omly assigned to receive trastuzumab or control . RESULTS Cancer H2 T levels varied 1808-fold . High H2 T levels were correlated with a positive HER2 status by CISH ( P < 0.0001 ) . A nonlinear association was present between H2 T and the hazard of distant recurrence in a sub population treatment effect pattern plot analysis in CISH-positive disease . Patients with very high H2 T ( defined by ≥22-fold the median of HER2-negative cancers ; 13 % of CISH-positive cancers ) did not benefit from adjuvant trastuzumab [ hazard ratio ( HR ) 1.23 ; 95 % confidence interval ( CI ) 0.33 - 4.62 ; P = 0.75 ] , whereas the rest of the patients with HER2-positive disease by CISH ( 87 % ) did benefit ( HR 0.52 ; 95 % CI 0.28 - 1.00 ; P = 0.050 ) . CONCLUSION Patients with HER2-positive breast cancer with very high tumor HER2 content may benefit less from adjuvant trastuzumab compared with those whose cancer has more moderate HER2 content PURPOSE To determine whether ( 1 ) immunohistochemical ( IHC ) HER2 status ( ie , 2 + or 3 + ) , ( 2 ) degree of fluorescence in situ hybridization ( FISH ) amplification according to ( 2a ) HER2/CEP17 ratio or ( 2b ) HER2 gene copy number , or ( 3 ) polysomy significantly influenced clinical outcome for patients with human epidermal growth factor receptor 2 ( HER2 ) -positive breast cancer enrolled in the Herceptin Adjuvant trial of trastuzumab versus no trastuzumab administered after completion of chemotherapy . PATIENTS AND METHODS IHC and /or FISH analyses were performed locally and required central confirmation as indicating HER2 positivity for trial entry . FISH data from the central HER2 analysis on patients in the 1-year trastuzumab and no trastuzumab arms were assessed in relation to disease-free survival ( DFS ) after a median 2 years of follow-up . RESULTS Central FISH results were available for 2,071 ( 61 % ) of the 3,401 patients r and omized to the 2 arms . Among patients with FISH-positive disease , ( 1 ) the hazard ratios for trastuzumab versus no trastuzumab were 0.56 ( 95 % CI , 0.32 to 0.99 ) for locally IHC2 + cases ( n = 340 ) and 0.80 ( 95 % CI , 0.40 to 1.61 ) for central ly IHC2 + cases ( n = 299 ) . There was no significant prognostic relationship between ( 2a ) HER2 FISH ratio , ( 2b ) HER2 copy number , or ( 3 ) polysomy and DFS in the control arm or predictive relationship defining differential benefit from trastuzumab . CONCLUSION There was no evidence for reduced benefit of trastuzumab in HER2 IHC2+FISH+ cases . The degree of HER2 amplification does not influence prognosis or benefit from adjuvant trastuzumab in patients treated with prior adjuvant chemotherapy BACKGROUND Trastuzumab , a recombinant monoclonal antibody against HER2 , has clinical activity in advanced breast cancer that overexpresses HER2 . We investigated its efficacy and safety after excision of early-stage breast cancer and completion of chemotherapy . METHODS This international , multicenter , r and omized trial compared one or two years of trastuzumab given every three weeks with observation in patients with HER2-positive and either node-negative or node-positive breast cancer who had completed locoregional therapy and at least four cycles of neoadjuvant or adjuvant chemotherapy . RESULTS Data were available for 1694 women r and omly assigned to two years of treatment with trastuzumab , 1694 women assigned to one year of trastuzumab , and 1693 women assigned to observation . We report here the results only of treatment with trastuzumab for one year or observation . At the first planned interim analysis ( median follow-up of one year ) , 347 events ( recurrence of breast cancer , contralateral breast cancer , second nonbreast malignant disease , or death ) were observed : 127 events in the trastuzumab group and 220 in the observation group . The unadjusted hazard ratio for an event in the trastuzumab group , as compared with the observation group , was 0.54 ( 95 percent confidence interval , 0.43 to 0.67 ; P<0.0001 by the log-rank test , crossing the interim analysis boundary ) , representing an absolute benefit in terms of disease-free survival at two years of 8.4 percentage points . Overall survival in the two groups was not significantly different ( 29 deaths with trastuzumab vs. 37 with observation ) . Severe cardiotoxicity developed in 0.5 percent of the women who were treated with trastuzumab . CONCLUSIONS One year of treatment with trastuzumab after adjuvant chemotherapy significantly improves disease-free survival among women with HER2-positive breast cancer . ( Clinical Trials.gov number , NCT00045032 .
Output:
| HER2 amplification level is not a prognostic factor for HER2-positive breast cancer with trastuzumab-based targeted therapy in the clinical adjuvant setting |
MS212432 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract Background : Awareness and use of electronic cigarettes ( e-cigs ) has increased significantly in the past five years , but little is known about the experiences , satisfaction , opinions and preferences of e-cigs users . Method : 1177 participants completed an online survey about their electronic cigarette preferences , of which 200 were r and omly selected for analysis . The data were analyzed using both qualitative and quantitative methods . Results : Participants found the design , the ability to customize , and the quality of vapour to be the most important characteristics of the device . Participants thought the most positive aspects of e-cig use were help to quit smoking , improved overall health , and reduced cost . The negative aspects associated with its use were mainly related to side effects , such as dry mouth . When asked to explain how e-cigs were used differently than cigarettes , participants reported puffing more regularly , but taking fewer puffs per session . Conclusions : Experienced e-cig users stated that initiating e-cig use helped them to quit or reduce their conventional smoking , which they believe reduced their health risks . In comparison to cigarette smoking , e-cig users reported using their e-cig more times per day , but with fewer puffs at each use time . Users acknowledged that more research is needed to underst and the safety and long-term effects of its use . They mentioned dry mouth as a common side effect and common problems with reliability of e-cigs . Underst and ing these views may help health professionals to assess and assist e-cig users , and in the future , may help regulators to improve quality and reduce risks BACKGROUND Few national surveys document the prevalence of e-cigarette use in the U.S. The existing metric to assess current use likely identifies individuals who have recently tried an e-cigarette but do not continue to use the product . PURPOSE To document the prevalence of e-cigarette ever use , current use , and established use in a nationally representative survey of current and former cigarette smokers in the U.S. METHODS A r and om sample of current and former cigarette smokers completed a web-based survey in June 2013 ( n=2,136 ) . Data were analyzed in November 2013 . Multivariate logistic regression identified demographic and smoking-related factors associated with each use category . Point estimates with 95 % CIs described e-cigarette use behaviors ( e.g. , preferred br and , purchasing patterns ) for each group . RESULTS Almost half of respondents had tried e-cigarettes ( 46.8 % ) , but prevalence of established use remained low ( 3.8 % ) . Although trial of e-cigarettes was highest among daily smokers , the odds of being an established e-cigarette user were greater for former smokers ( OR=3.24 , 95 % CI=1.13 , 9.30 , p<0.05 ) . Furthermore , e-cigarette preference and use patterns varied among ever , current , and established users . Established users reported using rechargeable e-cigarettes , having a regular br and , and using e-cigarettes at home and in the workplace at much higher levels than the " current use " metric captures . CONCLUSIONS Improved survey measures for e-cigarette use are needed . The identification of established e-cigarette users may provide insight to product features or other individual factors that are associated with sustained use of e-cigarettes Objectives : The objectives of this study were to assess the general public views and familiarity toward electronic cigarette ( e-cigarette ) in Kuantan , Malaysia . Methodology : A total of 277 Kuantan people were involved in this study . The question naire was distributed at r and om in shops , businesses , and public places in Kuantan . Statistical analysis was performed using SPSS ( version 17.0 ) . Results : From 400 participants , a total number of 277 ( 160 , 57.7 % men and 117 , 42.4 % women ) respondents completed the question naire . The mean age was 26.89 ± 9.8 years old . The majority of the study participants were male ( 57.7 % ) , Malay ( 83.8 % ) , Muslims ( 83.8 % ) , singles ( 69 % ) , and employed ( 75.8 % ) , with about 83 ( 29.9 % ) of the respondents were smokers . The prevalence of e-cigarettes smokers was found to be only 1.4 % ( n = 4 ) . About one-third of the respondents ( n = 72 , 26 % ) have tried e-cigarette before . Job status was significantly associated with smoking e-cigarette among the population ( P = 0.02 ) . Main factors for a person to start e-cigarette smoking were curiosity ( 37.5 % ) and cheaper price ( 40.8 % ) . Majority of respondents agreed that e-cigarette would not affect health as normal cigarette , and that variety of flavors contribute to better enjoyment ( 51.6 % and 66.7 % , respectively ) . Conclusion : The results of the current study demonstrate that the prevalence of e-cigarettes smoking and its popularity , familiarity , and knowledge are still insufficient among Kuantan population . Further studies should be done to tackle this problem before it getting worse Aims : Here , we present results from a prospect i ve pilot study that was aim ed at surveying changes in daily cigarette consumption in smokers making their first purchase at vape shops . Modifications in products purchase were also noted . Design : Participants were instructed how to charge , fill , activate and use their e-cigarettes ( e-cigs ) . Participants were encouraged to use these products in the anticipation of reducing the number of cig/day smoked . Setting s : Staff from LIAF contacted 10 vape shops in the province of the city of Catania ( Italy ) that acted as sponsors to the 2013 No Tobacco Day . Participants : 71 adult smokers ( ≥18 years old ) making their first purchase at local participating vape shops were asked by professional retail staff to complete a form . Measurements : Their cigarette consumption was followed-up prospect ively at 6 and 12 months . Details of products purchase ( i.e. , e-cigs hardware , e-liquid nicotine strengths and flavours ) were also noted . Findings : Retention rate was elevated , with 69 % of participants attending their final follow-up visit . At 12 month , 40.8 % subjects could be classified as quitters , 25.4 % as reducers and 33.8 % as failures . Switching from st and ard refillables ( initial choice ) to more advanced devices ( MODs ) was observed in this study ( from 8.5 % at baseline to 18.4 % at 12 month ) as well as a trend in decreasing the e-liquid nicotine strength , with more participants adopting low nicotine strength ( from 49.3 % at baseline to 57.1 % at 12 month ) . Conclusions : We have found that smokers purchasing e-cigarettes from vape shops with professional advice and support can achieve high success rates PURPOSE Electronic cigarettes ( e-cigarettes ) are a new type of device that delivers vaporized nicotine without the tobacco combustion of regular cigarettes . We sought to underst and awareness of and willingness to try e-cigarettes among adolescent males , a group that is at risk for smoking initiation and may use e-cigarettes as a " gateway " to smoking . METHODS A national sample of 11 - 19-year-old males ( n = 228 ) completed an online survey in November 2011 . We recruited participants through their parents , who were members of a panel of U.S. households constructed using r and om-digit dialing and addressed-based sampling . RESULTS Only two participants ( < 1 % ) had previously tried e-cigarettes . Among those who had not tried e-cigarettes , most ( 67 % ) had heard of them . Awareness was higher among older and non-Hispanic adolescents . Nearly 1 in 5 ( 18 % ) participants were willing to try either a plain or flavored e-cigarette , but willingness to try plain versus flavored varieties did not differ . Smokers were more willing to try any e-cigarette than nonsmokers ( 74 % vs. 13 % ; OR 10.25 , 95 % CI 2.88 , 36.46 ) . Nonsmokers who had more negative beliefs about the typical smoker were less willing to try e-cigarettes ( OR .58 , 95 % CI .43 , .79 ) . CONCLUSIONS Most adolescent males were aware of e-cigarettes , and a substantial minority were willing to try them . Given that even experimentation with e-cigarettes could lead to nicotine dependence and subsequent use of other tobacco products , regulatory and behavioral interventions are needed to prevent " gateway " use by adolescent nonsmokers . Campaigns promoting negative images of smokers or FDA bans on sales to youth may help deter use Background More US adolescents use e-cigarettes than smoke cigarettes . Research suggests flavoured e-cigarettes appeal to youth , but little is known about perceptions of and reasons for attraction to specific flavours . Methods A national sample of adolescents ( n=1125 ) ages 13–17 participated in a phone survey from November 2014 to June 2015 . We r and omly assigned adolescents to respond to survey items about 1 of 5 e-cigarette flavours ( tobacco , alcohol , menthol , c and y or fruit ) and used regression analysis to examine the impact of flavour on interest in trying e-cigarettes and harm beliefs . Results Adolescents were more likely to report interest in trying an e-cigarette offered by a friend if it were flavoured like menthol ( OR=4.00 , 95 % CI 1.46 to 10.97 ) , c and y ( OR=4.53 , 95 % CI 1.67 to 12.31 ) or fruit ( OR=6.49 , 95 % CI 2.48 to 17.01 ) compared with tobacco . Adolescents believed that fruit-flavoured e-cigarettes were less harmful to health than tobacco-flavoured e-cigarettes ( p<0.05 ) . Perceived harm mediated the relationship between some flavours and interest in trying e-cigarettes . A minority of adolescents believed that e-cigarettes did not have nicotine ( 14.6 % ) or did not know whether they had nicotine ( 3.6 % ) ; these beliefs did not vary by flavour . Discussion C and y-flavoured , fruit-flavoured and menthol-flavoured e-cigarettes appeal to adolescents more than tobacco-flavoured or alcohol-flavoured e-cigarettes . This appeal is only partially explained by beliefs about reduced harm . Given adolescents ' interest in trying e-cigarettes with certain flavours , policymakers should consider restricting advertisements promoting flavoured products in media that reach large numbers of young people . Future research should examine other reasons for the appeal of individual flavours , such as novelty and perceived luxury INTRODUCTION This study examined overall changes in nicotine concentrations when using a popular e-cigarette and 18 mg/mL nicotine e-Juice , and it further explored effects of sex and flavorings on these concentrations . METHODS We recruited nontreatment-seeking smokers who were willing to try e-cigarettes for 2 weeks and abstain from cigarette smoking . Subjects were r and omized to either menthol tobacco or non-menthol tobacco-flavored e-cigarette use for 7 - 10 days , and the next week they were crossed over to the other condition . On the last day of e-cigarette use of each flavor , subjects completed a laboratory session in which they used the e-cigarette for 5 min ad libitum . Nicotine concentrations were obtained 5 min before and 5 , 10 , 15 , 20 , and 30 min after the onset of e-cigarette use . RESULTS Twenty subjects completed at least 1 monitoring session . Nicotine concentrations significantly increased from baseline to 5 min by 4 ng/mL at the first laboratory session ( p < .01 ) and by 5.1 ng/mL at the second laboratory session ( p < .01 ) . Combining sessions , there were no main effects of sex or preferred flavor ( based on smoking history ) on changes in nicotine concentrations . After adding preferred flavor , sex , and visit order to the model , there was a significant preferred flavor by sex interaction ( p < .01 ) , such that women who received nonpreferred flavors had lower nicotine concentrations and rated their e-cigarette as less likeable ( p < .01 ) . CONCLUSION We found nicotine concentrations significantly increase after e-cigarette use for 5 min , and flavor may impact nicotine concentrations with e-cigarette use in women AIMS To ( 1 ) estimate predictors of first- versus second-generation electronic cigarette ( e-cigarette ) choice ; and ( 2 ) determine whether a second-generation device was ( i ) superior for reducing urge to smoke and withdrawal symptoms ( WS ) and ( ii ) associated with enhanced positive subjective effects . DESIGN Mixed-effects experimental design . Phase 1 : reason for e-cigarette choice was assessed via question naire . Phase 2 : participants were allocated r and omly to first- or second-generation e-cigarette condition . Urge to smoke and WS were measured before and 10 minutes after taking
Output:
| Consumers preferred flavored e-cigarettes , and such preference varied with age groups and smoking status .
We also found that several flavors were associated with decreased harm perception while tobacco flavor was associated with increased harm perception .
In addition , some flavor chemicals and sweeteners used in e-cigarettes could be of toxicological concern .
Adolescents could consider flavor the most important factor trying e-cigarettes and were more likely to initiate vaping through flavored e-cigarettes .
Young adults overall preferred sweet , menthol , and cherry flavors , while non-smokers in particular preferred coffee and menthol flavors .
Adults in general also preferred sweet flavors ( though smokers like tobacco flavor the most ) and disliked flavors that elicit bitterness or harshness .
In terms of whether flavored e-cigarettes assisted quitting smoking , we found inconclusive evidence .
E-cigarette users likely initiated use with a cigarette like product and transitioned to an advanced system with more features .
Non-smokers and inexperienced e-cigarettes users tended to prefer no nicotine or low nicotine e-cigarettes while smokers and experienced e-cigarettes users preferred medium and high nicotine e-cigarettes .
Weak evidence exists regarding a positive interaction between menthol flavor and nicotine strength |
MS212433 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Weekly docetaxel has occasionally been used in the neoadjuvant to downstage breast cancer to reduce toxicity and possibly enhance quality of life . However , no studies have compared the st and ard three weekly regimen to the weekly regimen in terms of quality of life . The primary aim of our study was to compare the effects on QoL of weekly versus 3-weekly sequential neoadjuvant docetaxel . Secondary aims were to determine the clinical and pathological responses , incidence of Breast Conserving Surgery ( BCS ) , Disease Free Survival ( DFS ) and Overall Survival ( OS ) . Methods Eighty-nine patients receiving four cycles of doxorubicin and cyclophosphamide were r and omised to receive twelve cycles of weekly docetaxel ( 33 mg/m2 ) or four cycles of 3-weekly docetaxel ( 100 mg/m2 ) . The Functional Assessment of Cancer Therapy-Breast and psychosocial question naires were completed . Results At a median follow-up of 71.5 months , there was no difference in the Trial Outcome Index scores between treatment groups . During weekly docetaxel , patients experienced less constipation , nail problems , neuropathy , tiredness , distress , depressed mood , and unhappiness . There were no differences in overall clinical response ( 93 % vs. 90 % ) , pathological complete response ( 20 % vs. 27 % ) , and breast-conserving surgery ( BCS ) rates ( 49 % vs. 42 % ) . Disease-free survival and overall survival were similar between treatment groups . Conclusions Weekly docetaxel is well-tolerated and has less distressing side-effects , without compromising therapeutic responses , Breast Conserving Surgery ( BCS ) or survival outcomes in the neoadjuvant setting .Trial registration IS RCT N : IS RCT PURPOSE Paclitaxel has significant antitumor activity in patients with metastaticbreast cancer who have been previously treated with or exposed to anthracycline-containing chemotherapy . In this prospect i ve r and omized trial , the role of paclitaxel was evaluated in an adjuvant setting to determine its impact on reducing the risk of recurrence in patients with operable breast cancer . EXPERIMENTAL DESIGN Five hundred twenty-four patients were r and omized to be treated either with 4 cycles of paclitaxel followed by 4 cycles of combination therapy with 5-fluorouracil , Adriamycin , and cyclophosphamide ( Pac/FAC ) or with 8 cycles of FAC alone . Patients with intact primary breast cancer received the initial 4 cycles of paclitaxel or 4 cycles of FAC in a neoadjuvant setting . Planned duration of therapy was the same in all patients . After completion of 8 cycles of chemotherapy , those patients who were > or = 50 years and whose tumors were positive for estrogen receptors received tamoxifen for 5 years . RESULTS Ninety-two patients have had a recurrence after a median follow-up of 60 months with a range of 5 - 89 months . Estimated disease-free survival at 48 months was 0.83 for FAC and 0.86 for Pac/FAC group . The difference between the two groups was not statistically significant ( P = 0.09 ) . The overall estimated hazard ratio for Pac/FAC compared with FAC derived by fitting the Cox regression model and incorporating terms for prognostic factors was 0.66 . CONCLUSION Preliminary results suggest that the addition of paclitaxel to a FAC regimen of adjuvant or neoadjuvant therapy may further reduce the risk of disease recurrence ; however , differences were not statistically significant . At the time of this analysis , there have been 47 deaths . The survival data are too preliminary to permit meaningful evaluation of the impact of paclitaxel on mortality BACKGROUND The aim of the study was to analyse the toxicity and health related quality of life ( HRQoL ) of breast cancer patients treated with FAC ( 5-fluorouracil , doxorubicin , cyclophosphamide ) and TAC ( docetaxel , doxorubicin , cyclophosphamide ) with and without primary prophylactic G-CSF ( PPG ) . PATIENTS AND METHODS This was a phase III study to compare FAC and TAC as adjuvant treatment of high-risk node-negative breast cancer patients . After the entry of the first 237 patients , the protocol was amended to include PPG in the TAC arm due to the high incidence of febrile neutropenia . A total of 1047 evaluable patients from 49 centres in Spain , two in Pol and and four in Germany were included in the trial . Side-effects and the scores of the EORTC QLQ-C30 and QLQ BR-23 question naires were compared in the three groups ( FAC , TAC pre-amendment and TAC post-amendment ) . RESULTS The addition of PPG to TAC significantly reduced the incidence of neutropenic fever , grade 2 - 4 anaemia , asthenia , anorexia , nail disorders , stomatitis , myalgia and dysgeusia . Patient QoL decreased during chemotherapy , more with TAC than FAC , but returned to baseline values afterwards . The addition of PPG to TAC significantly reduced the percentage of patients with clinical ly relevant Global Health Status deterioration ( 10 or more points over baseline value ) at the end of chemotherapy ( 64 % versus 46 % , P<0.03 ) . CONCLUSIONS The addition of PPG significantly reduces the incidence of neutropenic fever associated with TAC chemotherapy as well as that of some TAC-induced haematological and extrahaematological side-effects . The HRQoL of patients treated with TAC is worse than that of those treated with FAC but improves with the addition of PPG , particularly in the final part of chemotherapy treatment OBJECTIVE The 7-year follow-up of the US oncology 9735 trial demonstrated the superiority of TC [ docetaxel (DTX)/cyclophosphamide ( CPA ) ] to doxorubicin/CPA therapy . To introduce TC therapy in Japan , the verification of the safety and tolerability is essential . We performed a collaborative prospect i ve safety study with Okayama University to introduce TC therapy . METHODS The subjects were 53 patients aged from 33 to 67 years at intermediate risk based on the St Gallen risk classification who underwent radical surgery for primary breast cancer between August 2007 and December 2008 . As post-operative adjuvant chemotherapy , four cycles of TC ( DTX 75 mg/m(2 ) + CPA 600 mg/m(2 ) ) were administered at 3-week intervals . Adverse events were evaluated based on National Cancer Institute-Common Terminology Criteria for Adverse Events ver . 3.0 . The safety and completion rate were evaluated as the primary and secondary endpoints , respectively . RESULTS Regarding hematological toxicity , Grade ( G ) 4 neutropenia occurred in 71.7 % and G3 in 26.4 % . G3 - 4 leukopenia developed in 32.1 % and 56.6 % , respectively , G4 anemia in 1.9 % and G1 - 2 anemia in 26.4 % . Regarding non-hematological toxicity , systemic malaise , skin eruption , edema , myalgia , arthralgia and nausea were noted in most patients . The completion rate was 94.3 % , dose reduction was necessary in 7.5 % and granulocyte colony-stimulating factor ( G-CSF ) support was required in 17.0 % . On comparison between patients aged 65 years or older and younger than 65 years , the completion rate , dose reduction and incidence of febrile neutropenia ( FN ) were higher in the elderly patients . G-CSF support was more often needed in this subgroup . CONCLUSIONS TC therapy is tolerable for Japanese patients , but attention should be paid to the development of FN and neutropenia . The completion rate was lower in the elderly patients , showing that tolerability was not necessarily favorable PURPOSE We previously reported that four cycles of docetaxel/cyclophosphamide ( TC ) produced superior disease-free survival ( DFS ) compared with four cycles of doxorubicin/cyclophosphamide ( AC ) in early breast cancer . Older women are under-represented in adjuvant chemotherapy trials . In our trial 16 % of patients were > or = 65 years . We now report 7-year results for DFS and overall survival ( OS ) as well as the impact of age , hormone receptor status , and HER2 status on outcome and toxicity . PATIENTS AND METHODS Patients were r and omly assigned to receive either four cycles of st and ard-dose AC ( 60/600 mg/m(2 ) ; n = 510 ) , or TC ( 75/600 mg/m(2 ) ; n = 506 ) , administered by intravenous infusion every 3 weeks . RESULTS The median age in women younger than 65 , was 50 years ( range , 27 to 64 ) and for women > or = 65 was 69 years ( range , 65 to 77 ) . Baseline characteristics in the two age subgroups were generally well matched , except that older women tended to have more lymph node involvement . At a median of 7 years follow-up , the difference in DFS between TC and AC was significant ( 81 % TC v 75 % AC ; P = .033 ; hazard ratio [ HR ] , 0.74 ; 95 % CI 0.56 to 0.98 ) as was OS ( 87 % TC v 82 % AC ; P = .032 ; HR , 0.69 ; 95 % CI , 0.50 to 0.97 ) . TC was superior in older patients as well as younger patients . There was no interaction of hormone-receptor status or HER-2 status and treatment . Older women experienced more febrile neutropenia with TC and more anemia with AC . CONCLUSION With longer follow-up , four cycles of TC was superior to st and ard AC ( DFS and OS ) and was a tolerable regimen in both older and younger patients PURPOSE To determine the influence of the epirubicin dose in operable node-positive breast cancer patients with factors of poor prognosis . PATIENTS AND METHODS Between April 1990 and July 1993 , 565 operable breast cancer patients with either more than three positive nodes or between one and three positive nodes with Scarff Bloom Richardson grade > or = 2 and hormone receptor negativity were r and omized after surgery to receive either fluorouracil 500 mg/m(2 ) , epirubicin 50 mg/m(2 ) , and cyclophosphamide 500 mg/m(2 ) every 21 days for six cycles ( FEC 50 ) or the same regimen except with epirubicin dose of 100 mg/m(2 ) ( FEC 100 ) . Postmenopausal patients received tamoxifen 30 mg/d for 3 years at the beginning of chemotherapy . Radiotherapy was delivered at the end of chemotherapy in both groups . RESULTS The median follow-up was 67 months . The 5-year disease-free survival ( DFS ) was 54.8 % with FEC 50 and 66.3 % with FEC 100 ( P = .03 ) . The 5-year overall survival ( OS ) was 65.3 % and 77.4 % , respectively ( P = .007 ) . The mean relative dose-intensity was similar in the two groups ( 90.3 % and 86.1 % , respectively ) . Neutropenia and anemia were significantly more frequent in FEC 100 ( P < 10(-3 ) ) , as were nausea-vomiting ( P = .008 ) and stomatitis and alopecia ( P < 10(-3 ) ) . Nine cases of grade 3 infection occurred only with FEC 100 , and no toxic deaths occurred . Three cases of acute cardiac toxicity were observed ( FEC50 = 1 , FEC100 = 2 ) and 10 patients ( FEC50 = 6 , FEC100 = 4 ) presented delayed cardiac dysfunctions . Two cases of secondary leukemia were observed ( acute lymphatic leukemia with FEC 50 and acute myelogenous leukemia with FEC 100 ) . CONCLUSION After 5 years of follow-up , the increased epirubicin dose led to a significant benefit in terms of DFS and OS , with a high survival rate among patients with poor-prognosis breast cancer BACKGROUND Chemotherapy-induced neutropenia is the most common adverse effect of chemotherapy and is often complicated by febrile neutropenia ( FN ) . The objective of this study is to vali date a classification of aggressiveness of a chemotherapy regimen and to evaluate its usefulness in a risk prediction model of FN in patients with hematological cancer at the beginning of a chemotherapy cycle . PATIENTS AND METHODS Two hundred and sixty-six patients were prospect ively enrolled and followed during 1053 cycles . Relevant patient informations were collected at the beginning of the first cycle and the number of days of FN were counted in the follow-up [ dichotomized ( no FN versus > or= 1 day of FN ) ] . RESULTS Aggressive chemotherapy regimen is the major predictor of FN [ odds ratio 5.2 ( 3.2 - 8.4 ) ] . The other independent predictors are the underlying disease , an involvement of bone marrow , body surface
Output:
| FN rates in the observational studies are significantly higher than suggested by RCTs . |
MS212434 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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***EXAMPLES***
Input: The outcomes of a r and omized clinical trial of a new behavioral family intervention , Stepping Stones Triple P , for preschoolers with developmental and behavior problems are presented . Forty-eight children with developmental disabilities participated , 27 r and omly allocated to an intervention group and 20 to a wait-list control group . Parents completed measures of parenting style and stress , and independent observers assessed parent-child interactions . The intervention was associated with fewer child behavior problems reported by mothers and independent observers , improved maternal and paternal parenting style , and decreased maternal stress . All effects were maintained at 6-month follow-up The purpose of this study was to provide an experimental test of the theory of change put forth by A. T. Beck , A. J. Rush , B. F. Shaw , and G. Emery ( 1979 ) to explain the efficacy of cognitive-behavioral therapy ( CT ) for depression . The comparison involved r and omly assigning 150 out patients with major depression to a treatment focused exclusively on the behavioral activation ( BA ) component of CT , a treatment that included both BA and the teaching of skills to modify automatic thoughts ( AT ) , but excluding the components of CT focused on core schema , or the full CT treatment . Four experienced cognitive therapists conducted all treatments . Despite excellent adherence to treatment protocol s by the therapists , a clear bias favoring CT , and the competent performance of CT , there was no evidence that the complete treatment produced better outcomes , at either the termination of acute treatment or the 6-month follow-up , than either component treatment . Furthermore , both BA and AT treatments were just as effective as CT at altering negative thinking as well as dysfunctional attributional styles . Finally , attributional style was highly predictive of both short- and long-term outcomes in the BA condition , but not in the CT condition Objective : To examine the efficacy of teen online problem solving ( TOPS ) in improving executive function ( EF ) deficits following traumatic brain injury ( TBI ) in adolescence . Methods : Families of adolescents ( aged 11–18 years ) with moderate to severe TBI were recruited from the trauma registry of 2 tertiary-care children 's hospitals and then r and omly assigned to receive TOPS ( n = 20 ) , a cognitive-behavioral , skill-building intervention , or access to online re sources regarding TBI ( Internet re source comparison ; n = 21 ) . Parent and teen reports of EF were assessed at baseline and a posttreatment follow-up ( mean = 7.88 months later ) . Results : Improvements in self-reported EF skills were moderated by TBI severity , with teens with severe TBI in the TOPS treatment reporting significantly greater improvements than did those with severe TBI in the Internet re source comparison . The treatment groups did not differ on parent ratings of EF at the follow up . Conclusions : Findings suggest that TOPS may be effective in improving EF skills among teens with severe TBI Objective To describe a family-centered problem-solving intervention ( FPS ) for pediatric traumatic brain injury ( TBI ) , and to assess the efficacy of the intervention in a r and omized clinical trial . Participants Families of 32 school-aged children with moderate to severe TBI r and omly assigned to FPS or usual care ( UC ) group . Main Outcome Measures Child Behavior Checklist , Brief Symptom Inventory , Conflict Behavior Question naire . InterventionS even-session problem-solving/skill-building intervention delivered over a 6-month period for the participating families . Results Parents in the FPS group reported significantly greater improvements in their children in internalizing symptoms , anxiety/depression , and withdrawal than did parents in the UC comparison group . Conclusions FPS holds promise for reducing child behavior problems , the most common and persistent sequelae of TBI Primary objectives : To explore the relative effectiveness of clinician-delivered vs family-supported interventions for children with chronic impairment after TBI . Research design : R and omized controlled clinical trial . Methods and procedures : Children aged 5–12 years in the chronic phase of their recovery were r and omly assigned to the clinician-delivered or to the family-supported intervention group ; both sample s received intensive services for 1 year ; physical outcome was measured by the SARAH scales , cognitive outcome by the WISC-III . Main outcomes and results : Parents in the family-supported intervention sample efficiently acquired the skills needed to deliver physical and cognitive interventions within the context of everyday routines of the child 's life at home ; family education level was not a factor . Although both groups demonstrated improvements , only the children in the family-supported intervention group demonstrated statistically significant — and clinical ly important — improvements on both outcome measures . Conclusions : This RCT provides compelling evidence for organizing cognitive and physical interventions and supports for children with TBI around the everyday routines of their lives , with intensive supports for their families This study examined whether an online problem-solving intervention could improve parental adjustment following pediatric traumatic brain injury ( TBI ) . Families of children with moderate-to-severe TBI were recruited from the trauma registry of a large children 's hospital and r and omly assigned to receive online family problem solving therapy ( FPS ; n = 20 ) or Internet re sources ( IRC ; n = 20 ) in addition to usual care . The FPS group reported significantly less global distress , depressive symptoms , and anxiety at follow-up than did the IRC group after controlling for baseline symptoms . The FPS group also reported significant improvements in problem-solving skills , although the groups did not differ significantly at follow-up . Findings suggest that an online , skill-building approach can be effective in facilitating parental adaptation after TBI Whilst the Triple P Positive Parenting Program has a large evidence base ( S and ers , Clinical Child and Family Psychology Review 2:71–90 , 1999 ; S and ers , Journal of Consulting and Clinical Psychology 68:624–640 , 2000 ) and preliminary evidence indicates that Stepping Stones Triple P is also efficacious ( Roberts , Journal of Clinical Child and Adolescent Psychology , 35(2):180–193 , 2006 ) , to date Stepping Stones has not been evaluated with the ASD population . Fifty-nine families with a child with ASD aged between 2 and 9 participated in this r and omized controlled trial . The results demonstrate significant improvements in parental reports of child behaviour and parenting styles with the treatment effects for child behaviour , parental over reactivity and parental verbosity being maintained at follow-up 6 months later . Further , the results suggest significant improvements in parental satisfaction and conflict about parenting as well as a sleeper effect for parental efficacy . The results indicate that Stepping Stones Triple P is a promising intervention for parents of children with ASD . Limitations and future research are also addressed OBJECTIVES The aim was to examine functional outcomes following traumatic brain injury ( TBI ) during early childhood , to investigate impairments up to 5 years postinjury and identify predictors of outcome . METHODS The study compared three groups of children ( mild = 11 , moderate = 22 , severe = 15 ) , aged 2.0 - 6.11 years at injury , to a healthy control group ( n = 17 ) . Using a prospect i ve , longitudinal design , adaptive abilities , behavior , and family functioning were investigated acutely , 6 , 30 months and 5 years postinjury , with educational progress investigated at 30 months and 5 years postinjury . RESULTS A strong association was suggested between injury severity and outcomes across all domains . Further , 5-year outcomes in adaptive and behavioral domains were best predicted by preinjury levels of child function , and educational performance by injury severity . CONCLUSION Children who sustain a severe TBI in early childhood are at greatest risk of long-term impairment in day-to-day skills in the long-term postinjury
Output:
| Interventions that train parents may be a useful approach to alleviate behavioral and emotional disturbances after pediatric TBI .
Some evidence suggests that these interventions may help to improve parenting skill and adjustment .
However , all identified studies included interventions with multiple treatment components , so the effects attributable to parent training alone remain undetermined . |
MS212435 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Few clinical trials include sex as a factor . This analysis explored within-sex differences in response to opioid agonist medications . Males and females r and omly assigned to buprenorphine , LAAM , or methadone were compared on opioid use and retention in treatment . Females receiving buprenorphine had less objective drug use than females receiving methadone , while males receiving LAAM had less objective drug use than males receiving buprenorphine . Retention in treatment was longer for both sexes receiving methadone versus LAAM . Within-subject change results indicate that all three medications benefit both sexes . Clinical trials should be design ed to examine the impact of sex on outcomes BACKGROUND Genetic variations of the dopamine and opioid receptors could influence the response to methadone maintenance treatment ( MMT ) . METHODS We included 238 MMT patients according to their response to treatment and methadone dosing , along with 217 subjects without substance dependence . All were genotyped for polymorphisms of the dopamine D1 , D2 , micro-opioid and delta-opioid receptor genes . RESULTS The polymorphisms of the micro-opioid ( 118A > G ) , delta-opioid ( 921T > C ) , dopamine D1 ( DdeI ) and D2 ( TaqI A ) receptor genes were not associated with response to MMT and methadone dosing , whereas an association was found with the dopamine D2 receptor ( DRD2 ) 957C > T polymorphism . The 957CC carriers were more frequently non-responders to treatment ( OR=2.4 ; p=0.02 ) and presented a fourfold shorter period of negative urine screening ( p=0.02 ) . No significant differences in allele frequencies were observed between the MMT patients and the control group , suggesting no association of the analyzed polymorphisms with opioid dependence . CONCLUSIONS These results suggest that DRD2 genotype may contribute to the underst and ing of the interindividual variability to the response to MMT OBJECTIVE Women represent the largest percentage of new HIV infections globally . Yet , no large-scale studies have examined the experience of pain and its treatment in women living with HIV . DESIGN This study used structural equation modeling to examine sex differences in pain and the use and misuse of prescription analgesics in a representative sample of HIV+ persons in the United Stated within a prospect i ve , longitudinal design . OUTCOME MEASURES Bodily pain subscale of the Short-Form 36 and Modified Short Form of the World Health Organization 's Composite International Diagnostic Interview ( opioid misuse ) . RESULTS Women reported more pain than men over a roughly 6-month period regardless of mode of HIV transmission or prior drug use history . Men acknowledged more misuse of prescription analgesics over an approximate 1-year period compared with women , after taking into account pain , use of analgesics specifically for pain , and drug use history . Weaker associations between pain and use of analgesics specifically for pain that persisted over time were found among women compared with men . For both men and women , pain was stable over time . Problem drug use history exerted significant direct and indirect effects on pain , opioid misuse , and pain-specific analgesic use across sex . CONCLUSION The current findings are consistent with prior evidence indicating female pain predominance as well as the undertreatment of pain among women with HIV . Efforts should be made to improve the assessment and long-term management of pain in HIV+ persons INTRODUCTION We conducted a follow-up study to evaluate the outcome of a heroin-dependent population 25 years after their first enrollment in methadone maintenance treatment ( MMT ) . We assessed mortality in the sample plus actual drug use , treatment , and medical factors associated with drug dependence , focusing on possible gender differences . METHODS Prospect i ve follow-up study of 214 heroin-dependent patients consecutively admitted for MMT between 1980 and 1984 in the Asturias Public Health Service . The st and ardized mortality ratio ( SMR ) and 95 % confidence interval ( CI ) were calculated . An ad-hoc protocol on drug misuse and treatment , drug-related morbidity and Clinical Global Impression ( CGI ) scores were assessed in the survivors ' sample . RESULTS Information was received on 159 subjects , 106 of whom were deceased . Men accounted for 76.2 % of the study cohort . Over the 25-year follow-up period , the SMR was 22.51 ( 95 % CI=22.37 - 22.64 ) . In the survivors sample , 39.6 % were still enrolled in MMT ; human immunodeficiency virus ( HIV ) was diagnosed in 47.2 % and hepatitis B/C in 81.1 % ; current heroin use was reported by 22.6 % . There were no gender differences in mortality or HIV and hepatitis B/C status . None of the female survivors were using heroin at the 25-year follow-up compared with 31.1 % of males . CONCLUSIONS This study confirms the high mortality of heroin addicts even after enrollment in MMT . Severity of the addiction in terms of mortality was similar in both genders . Women who survived the 25-year follow-up were more likely to have stopped using heroin than men Abstract We prospect ively compared gender outcome among 470 MMT patients admitted between June 1993 and Dec 2002 . Urine sample s were analyzed for drug abuse after one month and after one year . On admission females 131(27.9 % ) were significantly younger ( 34.5 ± 7.5 years ) than males 339(72.1 % ) ( 37.3 ± 8.3 years ) ( ANOVA;F = 11 , p = 0.001 ) and had significantly higher cocaine abuse ( 20 % vs. 11.3 % ) ( Fisher 's Exact Test , p = 0.02 ) . After one year , groups had : ( a ) similar retention in treatment ( 76.3%-females , 72.6%-males ) , ( b ) stop in opiate abuse ( 65%-females , 65.3%-males ) , ( c ) a net decrease in cocaine abuse ( % positive that became negative minus % negative that became positive ) ( 68.0%-females , 51.6%-males ) . Females who were admitted to treatment while pregnant ( n = 45 ) were significantly younger ( 31.5 ± 5.4 years ) compared to 86 non-pregnant ( 36.1 ± 7.9 , ANOVA F = 12.1 , p = 0.001 ) . We concluded that compared to males , females started MMT younger and had a higher proportion of cocaine abuse even though females ' outcome were similar to males '
Output:
| Discussion We anticipate that this review will highlight how men and women differ in methadone treatment outcomes and allow us to generate conclusions that can be applied to treatment in a clinical setting . |
MS212436 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Few scientific studies have examined movement-based embodied contemplative practice s such as yoga and their effects on cognition . The purpose of this r and omized controlled trial was to examine the effects of an 8-week Hatha yoga intervention on executive function measures of task switching and working memory capacity . METHODS Community-dwelling older adults ( N = 118 ; mean age = 62.0 ) were r and omized to one of two groups : a Hatha yoga intervention or a stretching-strengthening control . Both groups participated in hour-long exercise classes 3 × /week over the 8-week study period . All participants completed established tests of executive function including the task switching paradigm , n-back and running memory span at baseline and follow-up . RESULTS Analysis of covariances showed significantly shorter reaction times on the mixed and repeat task switching trials ( partial η(2 ) = .04 , p < .05 ) for the Hatha yoga group . Higher accuracy was recorded on the single trials ( partial η(2 ) = .05 , p < .05 ) , the 2-back condition of the n-back ( partial η(2 ) = .08 , p < .001 ) , and partial recall scores ( partial η(2 ) = .06 , p < .01 ) of running span task . CONCLUSIONS Following 8 weeks of yoga practice , participants in the yoga intervention group showed significantly improved performance on the executive function measures of working memory capacity and efficiency of mental set shifting and flexibility compared with their stretching-strengthening counterparts . Although the underlying mechanisms need to be investigated , these results dem and larger systematic trials to thoroughly examine effects of yoga on executive function as well as across other domains of cognition , and its potential to maintain or improve cognitive functioning in the aging process OBJECTIVE We evaluated the effects of exercise on neurobehavioral function in healthy older people more than 75 years of age . DESIGN A r and omized controlled trial with 6-month follow-up was conducted . SETTING The study was performed in the rural town of Kahoku , Japan , the population of which is considered representative of the older population of Japan . PARTICIPANTS We studied 42 healthy volunteers ( 18 men and 24 women ; mean age , 79 years ( range 75 to 87 years ) ) who were r and omly assigned to one of two groups , exercise or control . INTERVENTION Subjects assigned to the exercise group were instructed to exercise for 60 minutes twice a week for 6 months . Subjects in the control group were not instructed to engage in an specific exercise regimen . MEASUREMENTS The following measurements were recorded for both groups at baseline and at 6-month follow-up : ( 1 ) Neurobehavioral function as determined by the following tests : Mini-Mental State Exam ( MMSE ) , Hasegawa Dementia Scale Revised ( HDSR ) , Visuospatial Cognitive Performance Test ( VCP-test ) , Button score , Up & Go test , and Functional Reach ; and ( 2 ) Body mass index and blood pressure . RESULTS The effects of exercise were shown in the Up & Go test , and Functional Reach ( ANOVA with repeated measures ) . CONCLUSION This study demonstrates the acceptability and effectiveness of exercise on neurobehavioral function , even in older people more than 75 years of age Physical exercise has been shown to increase brain volume and improve cognition in r and omized trials of non-demented elderly . Although greater social engagement was found to reduce dementia risk in observational studies , r and omized trials of social interventions have not been reported . A representative sample of 120 elderly from Shanghai , China was r and omized to four groups ( Tai Chi , Walking , Social Interaction , No Intervention ) for 40 weeks . Two MRIs were obtained , one before the intervention period , the other after . A neuropsychological battery was administered at baseline , 20 weeks , and 40 weeks . Comparison of changes in brain volumes in intervention groups with the No Intervention group were assessed by t-tests . Time-intervention group interactions for neuropsychological measures were evaluated with repeated- measures mixed models . Compared to the No Intervention group , significant increases in brain volume were seen in the Tai Chi and Social Intervention groups ( p < 0.05 ) . Improvements also were observed in several neuropsychological measures in the Tai Chi group , including the Mattis Dementia Rating Scale score ( p = 0.004 ) , the Trailmaking Test A ( p = 0.002 ) and B ( p = 0.0002 ) , the Auditory Verbal Learning Test ( p = 0.009 ) , and verbal fluency for animals ( p = 0.01 ) . The Social Interaction group showed improvement on some , but fewer neuropsychological indices . No differences were observed between the Walking and No Intervention groups . The findings differ from previous clinical trials in showing increases in brain volume and improvements in cognition with a largely non-aerobic exercise ( Tai Chi ) . In addition , intellectual stimulation through social interaction was associated with increases in brain volume as well as with some cognitive improvements Background Mild cognitive impairment ( MCI ) is a well-recognised risk factor for dementia and represents a vital opportunity for intervening . Exercise is a promising strategy for combating cognitive decline by improving brain structure and function . Specifically , aerobic training ( AT ) improved spatial memory and hippocampal volume in healthy community-dwelling older adults . In older women with probable MCI , we previously demonstrated that resistance training ( RT ) and AT improved memory . In this secondary analysis , we investigated : ( 1 ) the effect of RT and AT on hippocampal volume and ( 2 ) the association between change in hippocampal volume and change in memory . Methods 86 women aged 70–80 years with probable MCI were r and omly assigned to a 6-month , twice-weekly programme of : ( 1 ) AT , ( 2 ) RT or ( 3 ) balance and tone training ( BAT ; ie , control ) . At baseline and trial completion , participants performed a 3 T MRI scan to determine hippocampal volume . Verbal memory and learning were assessed by Rey 's Auditory Verbal Learning Test . Results Compared with the BAT group , AT significantly improved left , right and total hippocampal volumes ( p≤0.03 ) . After accounting for baseline cognitive function and experimental group , increased left hippocampal volume was independently associated with reduced verbal memory and learning performance as indexed by loss after interference ( r=0.42 , p=0.03 ) . Conclusions Aerobic training significantly increased hippocampal volume in older women with probable MCI . More research is needed to ascertain the relevance of exercise-induced changes in hippocampal volume on memory performance in older adults with MCI . Trail registration number NCT00958867 This study aim ed to investigate the effects of a long-term resistance exercise intervention on executive functions in healthy elderly males , and to further underst and the potential neurophysiological mechanisms mediating the changes . The study assessed forty-eight healthy elderly males r and omly assigned to exercise ( n = 24 ) or control ( n = 24 ) groups . The assessment included neuropsychological and neuroelectric measures during a variant of the oddball task paradigm , as well as growth hormone ( GH ) , insulin-like growth factor-1 ( IGF-1 ) , and homocysteine levels at baseline and after either a 12 month intervention of resistance exercise training or control period . The results showed that the control group had a significantly lower accuracy rate and smaller P3a and P3b amplitudes in the oddball condition after 12 months . The exercise group exhibited improved reaction times ( RTs ) , sustained P3a and P3b amplitudes , increased levels of serum IGF-1 , and decreased levels of serum homocysteine . The changes in IGF-1 levels were significantly correlated with the changes in RT and P3b amplitude of the oddball condition in the exercise group . In conclusion , significantly enhanced serum IGF-1 levels after 12 months of resistance exercise were inversely correlated with neurocognitive decline in the elderly . These findings suggest that regular resistance exercise might be a promising strategy to attenuate the trajectory of cognitive aging in healthy elderly individuals , possibly mediated by IGF-1 BACKGROUND Subjects with a mild cognitive impairment ( MCI ) have a memory impairment beyond that expected for age and education yet are not demented . These subjects are becoming the focus of many prediction studies and early intervention trials . OBJECTIVE To characterize clinical ly subjects with MCI cross-sectionally and longitudinally . DESIGN A prospect i ve , longitudinal inception cohort . SETTING General community clinic . PARTICIPANTS A sample of 76 consecutively evaluated subjects with MCI were compared with 234 healthy control subjects and 106 patients with mild Alzheimer disease ( AD ) , all from a community setting as part of the Mayo Clinic Alzheimer 's Disease Center/Alzheimer 's Disease Patient Registry , Rochester , Minn. MAIN OUTCOME MEASURES The 3 groups of individuals were compared on demographic factors and measures of cognitive function including the Mini-Mental State Examination , Wechsler Adult Intelligence Scale-Revised , Wechsler Memory Scale-Revised , Dementia Rating Scale , Free and Cued Selective Reminding Test , and Auditory Verbal Learning Test . Clinical classifications of dementia and AD were determined according to the Diagnostic and Statistical Manual of Mental Disorders , Revised Third Edition and the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer 's Disease and Related Disorders Association criteria , respectively . RESULTS The primary distinction between control subjects and subjects with MCI was in the area of memory , while other cognitive functions were comparable . However , when the subjects with MCI were compared with the patients with very mild AD , memory performance was similar , but patients with AD were more impaired in other cognitive domains as well . Longitudinal performance demonstrated that the subjects with MCI declined at a rate greater than that of the controls but less rapidly than the patients with mild AD . CONCLUSIONS Patients who meet the criteria for MCI can be differentiated from healthy control subjects and those with very mild AD . They appear to constitute a clinical entity that can be characterized for treatment interventions Strength training has been reported as a potentially useful exercise to improve psychological aspects in the elderly , but its effects remain controversial . This study investigated the effectiveness of strength training conducted twice a week for 12 weeks for improving health-related quality of life ( HRQOL ) and executive cognitive function . The study was a single-blind r and omized controlled trial with assessment s before and after intervention . HRQOL and executive function were assessed using the SF-36 Health Status Survey and a computerized neuro-cognitive assessment using task-switch reaction time trials , respectively . Subjects comprised 119 participants > or = 65 years old , r and omized to either strength training ( n=65 ) or health education classes ( controls , n=54 ) . The strength training program was design ed to strengthen the large muscle groups most important for functional activities and to improve balance . The effects of the intervention on the eight dimensions of the SF-36 in the control and training groups were analyzed . Only the mental health scale of the SF-36 was significantly improved for the training group compared with controls after 12 weeks . Task-switch reaction time and correct response rate remained unchanged . Short-term strength training might have modest positive effects on HRQOL , although this training period may not be sufficient to affect executive function in relatively healthy older people The aim of this study was to investigate the effects of a 6-month exercise program on cognitive function and blood viscosity in sedentary elderly men . Forty-six healthy inactive men , aged 60–75 years were r and omly distributed into a control group ( n=23 ) and an experimental group ( n=23 ) . Participants underwent blood analysis and physical and memory evaluation , before and after the 6-month program of physical exercise . The control group was instructed not to alter its everyday activities ; the experimental group took part in the fitness program . The program was conducted using a cycle ergometer , 3 times per week on alternate days , with intensity and volume individualized at ventilatory threshold 1 . Sessions were continuous and maximum duration was 60 min each . There was significant improvement in memory ( 21 % ; P<0.05 ) , decreased blood viscosity ( −19 % ; P<0.05 ) , and higher aerobic capacity ( 48 % ; P<0.05 ) among participants in the experimental group compared with the control group . These data suggest that taking part in an aerobic physical fitness program at an intensity corresponding to ventilatory threshold-1 may be considered a nonmedication alternative to improve physical and cognitive function The aims of this study were to examine the effects of aerobic exercise on measures of executive performance and their relationships with changes in cardiorespiratory fitness , cardiac vagal control ( heart rate variability ) and psychological variables . Thirty-six sedentary seniors aged 60 - 75 years were r and omly assigned to a swimming and aquaerobics program or a stretching program two times a week for 21 weeks . Executive functions ( inhibition , updating of working memory and cognitive flexibility ) and cardiorespiratory fitness ( estimated VO2max ) were assessed at the start , after 10 weeks of program and at the end of the program . Resting HRV and measures of psychological outcomes ( depression , self-efficacy , decisional balance ) were obtained at the start and at the end of the program . Participants of both groups significantly improved their VO2max level , their psychological state and their performance for the 2-back task . Only the participants in the aquaerobics group significantly improved their vagally-mediated HRV and their performance for the Stroop test and the verbal running-span test at the end of the program . Only improvements in cardiac vagal control and in inhibition were shown to be functionally related . These results are discussed in line with the model of neurovisceral integration CONTEXT Evidence suggests that physical activity may be related to the clinical expression of dementia . Whether the association includes low-intensity activity such as walking is not known .
Output:
| When exercise prescription was examined , a duration of 45–60 min per session and at least moderate intensity , were associated with benefits to cognition .
Conclusions Physical exercise improved cognitive function in the over 50s , regardless of the cognitive status of participants . |
MS212437 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background — Traditional reperfusion options for patients with acute ST-segment elevation myocardial infa rct ion ( STEMI ) presenting to non- primary percutaneous coronary intervention (PPCI)-capable hospitals generally include onsite fibrinolytics or emergency transfer for PPCI . A third option , involving interventionalist transfer , was examined in the REVERSE-STEMI study . Methods and Results — A total of 334 patients with acute STEMI who presented to 5 referral hospitals with angiographic facilities but without interventionalists qualified for PPCI were r and omized to receive PPCI with either an interventionalist- ( n=165 ) or a patient-transfer ( n=169 ) strategy . The primary end point of door-to-balloon ( D2B ) time and secondary end points of left ventricular ejection fraction and major adverse cardiac events ( MACE ) at 1-year clinical follow-up were compared between the 2 groups . Compared with the patient-transfer strategy , the interventionalist-transfer strategy result ed in a significantly shortened D2B time ( median , 92 minutes versus 141 minutes ; P<0.0001 ) , with more patients having first balloon angioplasty within 90 minutes ( 21.2 % versus 7.7 % , P<0.001 ) . This treatment strategy also was associated with higher left ventricular ejection fraction ( 0.60±0.07 versus 0.57±0.09 , P<0.001 ) and improved 1-year MACE-free survival ( 84.8 % versus 74.6 % , P=0.019 ) . Multivariate Cox proportional hazards modeling revealed that the interventionalist-transfer strategy was an independent factor for reduced risk of composite MACE ( hazard ratio , 0.63 ; 95 % CI , 0.45 to 0.88 ; P=0.003 ) . Conclusions — The interventionalist-transfer strategy for PPCI may be effective in improving the care of patients with STEMI presenting to a non-PPCI-capable hospital , particularly in a congested cosmopolitan region where patient transfers could be prolonged . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00713557 AIMS We investigated the net benefit in the outcome of reducing treatment delay through field triage and emergency department ( ED ) bypass in patients with ST-elevation myocardial infa rct ion ( STEMI ) treated with primary angioplasty . METHODS AND RESULTS In a prospect i ve registry study , consecutive patients with suspected STEMI were assigned to : ( i ) pre-hospital ECG and triage or ( ii ) ECG and triage at the closest ED , solely based on ambulance availability . Four district hospitals and one regional heart centre serviced the 890,000 population metropolitan area and primary angioplasty was the only reperfusion strategy employed . Baseline characteristics were similar in STEMI patients triaged in the field ( 108 ) and the EDs ( 193 ) . Symptom onset to balloon times : 154 [ inter-quartile range ( IQR ) 120 - 233 ) vs. 249 ( IQR 184 - 405 ) min ( P<0.001 ) and peak creatine kinase in early presenters ( < 2 h ) : 1435 ( 95 % CI : 904 - 1966 ) U/L vs. 2320 ( 95 % CI : 1881 - 2762 ) U/L ( P=0.009 ) were lower in field- than in ED-triaged patients . Mortality in the PCI treated were 1.1 and 8.2 % [ P=0.025 , RR 0.14 ( 95 % CI : 0.01 - 1.08 ) ] and overall mortality were 1.9 and 7.3 % [ P=0.046 , RR 0.26 ( 95 % CI : 0.05 - 1.11 ) ] . CONCLUSION Field-triage and ED bypass were feasible means of reducing treatment delay in patients with suspected STEMI and result ed in smaller infa rct size in early presenters and a trend towards a reduction in mortality Objective To investigate the potential benefit of an earliest possible out-of-hospital start of abciximab ( ReoPro ) therapy in ST-elevation myocardial infa rct ion ( STEMI ; Lilly , Bad Homburg , Germany ) and planned primary percutaneous intervention compared with periprocedural abciximab treatment on reperfusion and clinical outcome . Methods R and omization of one hundred and one patients with STEMI to prehospital or periprocedural abciximab treatment . Evaluation of thrombolysis in myocardial infa rct ion ( TIMI ) flow , ST-segment resolution , myocardial blush grade , and maximal creatine kinase release before and after as well as clinical follow-up until 6 months after the index event . Results Prehospital abciximab ( group 1 ) was initiated a median of 101 min ( 37–165 min ) earlier compared with periprocedural treatment ( group 2 ) . Initial TIMI 3 flow ( 24 vs. 15 % , P = NS ) , ST-segment resolution before percutaneous coronary intervention ( PCI ) ( < 30 % : 33 vs. 46 % , P = NS ; > 70 % : 38 vs. 33 % , P = NS ) , post-PCI myocardial blush grade 2 and 3 ( 72 vs. 75 % , P = NS ) , maximal cardiac enzyme release ( creatinine kinase MB median 77 U/l ; range 33–137 vs. 74 U/l ; range 39–143 U/l , P = NS ) , and 6 months follow-up ( recurrent myocardial infa rct ion or repeat coronary intervention , and PCI , need for coronary bypass surgery ) did not differ significantly between both treatment groups . Conclusion Prehospital intravenous administration of abciximab , although safe and feasible in a trained surrounding , does not add angiographic or clinical benefit to patients with STEMI BACKGROUND Although both prehospital fibrinolysis and primary angioplasty provide a clinical benefit over in-hospital fibrinolysis in acute myocardial infa rct ion , they have not been directly compared . Our aim was to find out whether primary angioplasty was better than prehospital fibrinolysis . METHODS We did a r and omised multicentre trial of 840 patients ( of 1200 planned ) who presented within 6 h of acute myocardial infa rct ion with ST-segment elevation , initially managed by mobile emergency-care units . We assigned patients to prehospital fibrinolysis ( n=419 ) with accelerated alteplase or primary angioplasty ( n=421 ) , and transferred all to a centre with access to emergency angioplasty . Our primary endpoint was a composite of death , non-fatal reinfa rct ion , and non-fatal disabling stroke at 30 days . Analyses were by intention to treat . FINDINGS The median delay between onset of symptoms and treatment was 130 min in the prehospital-fibrinolysis group and 190 min ( time to first balloon inflation ) in the primary -angioplasty group . Rescue angioplasty was done in 26 % of the patients in the fibrinolysis group . The rate of the primary endpoint was 8.2 % ( 34 patients ) in the prehospital-fibrinolysis group and 6.2 % ( 26 patients ) in the primary -angioplasty group ( risk difference 1.96 , 95 % CI -1.53 to 5.46 ) . 16 ( 3.8 % ) patients assigned prehospital fibrinolysis and 20 ( 4.8 % ) assigned primary angioplasty died ( p=0.61 ) . INTERPRETATION A strategy of primary angioplasty was not better than a strategy of prehospital fibrinolysis ( with transfer to an interventional facility for possible rescue angioplasty ) in patients presenting with early myocardial infa rct ion OBJECTIVE To assess the safety and feasibility of acute transport followed by rescue percutaneous transluminal coronary angioplasty ( PTCA ) or primary PTCA in patients with acute myocardial infa rct ion initially admitted to a hospital without PTCA facilities . DESIGN In a multicentre r and omised open trial , three regimens of treatment of acute large myocardial infa rct ion were compared for patients admitted to hospitals without angioplasty facilities : thrombolytic treatment with alteplase ( 75 patients ) , alteplase followed by transfer to the PTCA centre and ( if indicated ) rescue PTCA ( 74 patients ) , or transfer for primary PTCA ( 75 patients ) . RESULTS Between 1995 and 1997 224 patients were included . Baseline characteristics were distributed evenly . Transport to the PTCA centre was without severe complications in all patients . Mean ( SD ) delay from onset of symptoms to r and omisation was 130 ( 75 ) minutes and from r and omisation to angiography 90 ( 25 ) minutes . Death or recurrent infa rct ion within 42 days occurred in 12 patients in the thrombolysis group , in 10 patients in the rescue PTCA group , and in six patients in the primary PTCA group . These differences were not significant . CONCLUSIONS Acute transfer for rescue PTCA or primary PTCA in patients with extensive myocardial infa rct ion is feasible and safe . Efficacy of rescue PTCA or primary PTCA in this setting will have to be tested in larger series before this approach can be implemented as “ routine treatment ” for patients with extensive myocardial infa rct ion BACKGROUND For the treatment of myocardial infa rct ion with ST-segment elevation , primary angioplasty is considered superior to fibrinolysis for patients who are admitted to hospitals with angioplasty facilities . Whether this benefit is maintained for patients who require transportation from a community hospital to a center where invasive treatment is available is uncertain . METHODS We r and omly assigned 1572 patients with acute myocardial infa rct ion to treatment with angioplasty or accelerated treatment with intravenous alteplase ; 1129 patients were enrolled at 24 referral hospitals and 443 patients at 5 invasive-treatment centers . The primary study end point was a composite of death , clinical evidence of reinfa rct ion , or disabling stroke at 30 days . RESULTS Among patients who underwent r and omization at referral hospitals , the primary end point was reached in 8.5 percent of the patients in the angioplasty group , as compared with 14.2 percent of those in the fibrinolysis group ( P=0.002 ) . The results were similar among patients who were enrolled at invasive-treatment centers : 6.7 percent of the patients in the angioplasty group reached the primary end point , as compared with 12.3 percent in the fibrinolysis group ( P=0.05 ) . Among all patients , the better outcome after angioplasty was driven primarily by a reduction in the rate of reinfa rct ion ( 1.6 percent in the angioplasty group vs. 6.3 percent in the fibrinolysis group , P<0.001 ) ; no significant differences were observed in the rate of death ( 6.6 percent vs. 7.8 percent , P=0.35 ) or the rate of stroke ( 1.1 percent vs. 2.0 percent , P=0.15 ) . Ninety-six percent of patients were transferred from referral hospitals to an invasive-treatment center within two hours . CONCLUSIONS A strategy for reperfusion involving the transfer of patients to an invasive-treatment center for primary angioplasty is superior to on-site fibrinolysis , provided that the transfer takes two hours or less Background — The value of prehospital initiation of glycoprotein IIb/IIIa inhibitors remains a controversial issue . We sought to investigate whether in-ambulance initiation of abciximab in patients with ST-segment elevation myocardial infa rct ion ( STEMI ) improves ST-segment elevation resolution ( STR ) after primary percutaneous coronary intervention ( PCI ) . Methods and Results — MISTRAL ( Myocardial Infa rct ion with ST-elevation Treated by Primary Percutaneous Intervention Facilitated by Early Reopro Administration in Alsace ) is a prospect i ve , r and omized , double-blind study . Two hundred and fifty-six patients with acute STEMI were allocated to receive abciximab either in the ambulance ( ambulance group , n=127 ) or in the catheterization laboratory ( hospital group , n=129 ) . The primary end point was complete ( > 70 % ) STR after PCI . Complete STR was not significantly different between the 2 groups ( before PCI , 21.6 % versus 15.5 % , P=0.28 ; after PCI , 70.3 % versus 65.8 % , P=0.49 ) . Thrombolysis In Myocardial Infa rct ion ( TIMI ) 2 to 3 flow rates before PCI tended to be higher in the ambulance group ( 46.8 % versus 35 % , P=0.08 ) but not after PCI ( 70.3 % versus 65.8 % , P=0.49 ) . Slow flow tended to be lower ( 5.6 % versus 13.4 % , P=0.07 ) , and distal embolization occurred significantly less often in the ambulance group
Output:
| Conclusion : Field triage compared to referral via a spoke centre leads to a lower 30-day mortality in STEMI patients . |
MS212438 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Genetic testing for inherited germ-line mutations associated with cancer susceptibility is an emerging technology in medical practice . Limited information is currently available about physician use of cancer susceptibility tests ( CSTs ) . In 1999 - 2000 , a nationally representative survey was conducted to estimate prevalence of CST use by United States physicians and assess demographic , training , practice setting , and practice patterns associated with use . A stratified r and om sample of clinicians in eight specialties was selected from a file of all licensed physicians . In total , 1251 physicians , including 820 in primary care and 431 in tertiary care , responded to a 15-min question naire by mail , telephone , fax , or Internet ( response rate = 71.0 % ) . In the previous 12 months , 31.2 % [ 95 % confidence interval ( CI ) , 28.5 - 33.9 ] overall , including 30.6 % ( 95 % CI , 27.5 - 33.7 ) in primary care and 33.4 % ( 95 % CI , 27.9 - 38.9 ) in tertiary care , had ordered CSTs or referred patients elsewhere for risk assessment or testing . More physicians referred patients elsewhere [ 26.7 % ( 95 % CI , 24.2 - 29.2 ) ] than directly ordered tests [ 7.9 % ( 95 % CI , 6.3 - 9.5 ) ] . Factors associated with ordering or referring included practice location in the Northeast [ odds ratio ( OR ) , 2.30 ; 95 % CI , 1.46 - 3.63 % ] , feeling qualified to recommend CSTs ( OR , 1.96 ; 95 % CI = 1.41 - 2.72 ) , receiving CST advertising material s ( OR , 1.97 ; 95 % CI , 1.40 - 2.78 % ) , and most notably , having patients who asked whether they can or should get tested ( OR , 5.52 ; 95 % CI , 3.97 - 7.67 % ) . Lower CST use was associated with not knowing if there were local testing and counseling facilities ( OR , 0.39 ; 95 % CI , 0.23 - 0.66 % ) . These findings underscore the importance of establishing effective clinical approaches to test use and promoting physician education to facilitate communication with patients about cancer genetics Purpose : Genetic screening can enable timely detection and treatment of hereditary hemochromatosis ( HH ) . Little is known about patient acceptability of DNA testing as compared to conventional phenotypic testing . Methods : Within the HEIRS Study , a large primary -care screening study of HH and iron overload , we r and omly assigned participants to receive brief information on either HH genotypic or phenotypic testing , and assessed the willingness to accept this test . The study was design ed to recruit an equal number of African Americans and Caucasians . Results : A total of 2500 participants were recruited from waiting rooms of primary care practice s ; 2165 participants who self-identified as African Americans and Caucasians were included in the analyses . Overall , 56 % had accepted a genotypic test versus 58 % for a phenotypic test . Adjusting for Field Center ( FC ) , age , gender , race , educational attainment , global health rating , and knowledge of the test , the odds ratio of accepting a genotypic versus phenotypic test was 0.85 ( 95 % CI : 0.71 , 1.02 ; P = 0.078 ) . Characteristics associated with test acceptance were age 45–64 years , female gender , Caucasian race , self-rated health less than “ very good ” , and knowledge of the test . Test acceptance was associated with interest in knowing more about health ( 81 % ) and in helping family members ( 71 % ) . Refusal reasons included a need to talk with a doctor ( 44 % ) , concern about privacy ( 32 % ) , and dislike of blood drawing ( 29 % ) . Conclusion : In this diverse sample of primary care patients , stated acceptance of genotypic testing for HH mutations was similar to phenotypic testing for blood iron . Patient education regarding the nature of test , importance of disease detection , and privacy protection appear to be essential for achieving high rates of screening participation OBJECTIVE To examine the relationship between health beliefs and attitudes toward colorectal cancer screening , strength of family history risk , and being appropriately screened for colorectal cancer . METHODS In February 2004 , 7000 r and omly selected members of a multi-specialty group practice located in Boston , MA were mailed a brief survey that was used to ascertain colorectal cancer family history . A follow-up survey that contained questions representing selected constructs of the Health Belief Model , Theory of Planned Behavior , and healthcare experiences was then mailed to all 355 individuals who reported a family history in the initial survey and 710 r and omly selected participants with no colorectal cancer family history . RESULTS Participants who were appropriately screened had higher mean scores for perceived cancer risk , subjective norms , and perceived benefits and lower scores for perceived barriers . Multivariate findings indicate that having high perceptions of risk for colorectal cancer was a significant correlate of being screened appropriately among individuals with a strong family history . CONCLUSIONS For those at greatest colorectal cancer risk due to family history , ensuring that these individuals underst and their personal risk might lead to increased colorectal cancer screening participation . Future intervention research is warranted to examine if raising perceptions of risk can increase screening behaviors in individuals with colorectal cancer risk due to family history Background — Pharmacogenetic-guided dosing of warfarin is a promising application of “ personalized medicine ” but has not been adequately tested in r and omized trials . Methods and Results — Consenting patients ( n=206 ) being initiated on warfarin were r and omized to pharmacogenetic-guided or st and ard dosing . Buccal swab DNA was genotyped for CYP2C9 * 2 and CYP2C9 * 3 and VKORC1C1173 T with a rapid assay . St and ard dosing followed an empirical protocol , whereas pharmacogenetic-guided dosing followed a regression equation including the 3 genetic variants and age , sex , and weight . Prothrombin time international normalized ratio ( INR ) was measured routinely on days 0 , 3 , 5 , 8 , 21 , 60 , and 90 . A research pharmacist unblinded to treatment strategy managed dose adjustments . Patients were followed up for up to 3 months . Pharmacogenetic-guided predicted doses more accurately approximated stable doses ( P<0.001 ) , result ing in smaller ( P=0.002 ) and fewer ( P=0.03 ) dosing changes and INRs ( P=0.06 ) . However , percent out-of-range INRs ( pharmacogenetic=30.7 % , st and ard=33.1 % ) , the primary end point , did not differ significantly between arms . Despite this , when restricted to wild-type patients ( who required larger doses ; P=0.001 ) and multiple variant carriers ( who required smaller doses ; P<0.001 ) in exploratory analyses , results ( pharmacogenetic=29 % , st and ard=39 % ) achieved nominal significance ( P=0.03 ) . Multiple variant allele carriers were at increased risk of an INR of ≥4 ( P=0.03 ) . Conclusions — An algorithm guided by pharmacogenetic and clinical factors improved the accuracy and efficiency of warfarin dose initiation . Despite this , the primary end point of a reduction in out-of-range INRs was not achieved . In subset analyses , pharmacogenetic guidance showed promise for wild-type and multiple variant genotypes Purpose : To determine the genetics education needs and priorities of dietitians , occupational therapists , physical therapists , psychologists , speech- language -hearing specialists , and social workers . Methods : A r and om sample mail survey of 3600 members of 6 national health professional organizations was undertaken in 1998 and result ed in 1958 responses . Results : A majority worked with clients with genetic conditions , most were providing genetic services to some clients , few had high confidence in providing genetic services , most had little or no education in genetics , and two-thirds wanted continuing education . Conclusion : The study shows a critical need for genetics education of allied and counseling health professionals Genetic testing for an inherited susceptibility to cancer is an emerging technology in medical practice . Little information is currently available about physicians ' attitudes toward these tests . To assess US physicians ' opinions on unresolved issues surrounding genetic testing , a 15‐min survey was administered to a stratified r and om sample of 1,251 physicians from 8 specialties , selected from a file of all licensed physicians in the US ( response rate = 71.0 % ) . Dependent measures included physicians ' attitudes toward genetic counseling and testing qualifications , availability of guidelines , patient confidentiality and insurance discrimination issues , and clinical utility of genetic tests . More than 89 % of physicians reported a need for physician guidelines , 81 % thought that patients with positive genetic test results are at risk for insurance discrimination , and more than 53 % thought that it was difficult to ensure the confidentiality of test results . Almost 25 % indicated that genetic tests for cancer susceptibility have too many inaccurate or ambiguous results ; nearly 75 % thought that clear guidelines are not available for managing patients with positive test results . Only 29 % of physicians reported feeling qualified to provide genetic counseling to their patients . More than 84 % of oncologists considered themselves qualified to recommend genetic testing to their patients compared with 40 % of primary care physicians ( PCPs ) , and 57 % of tertiary care physicians ( TCPs ) . US physicians expressed great uncertainty about issues surrounding genetic testing for cancer susceptibility . Results of this national survey underscore the need to provide physicians with clear guidelines on the use of genetic cancer susceptibility tests and effective medical training on their appropriate implementation . Published 2003 Wiley‐Liss , There is a need to integrate primary - and secondary -care cancer genetic services , but the most appropriate model of service delivery remains unclear . This study reports patients ’ expectations of breast cancer genetic services and a comparison of their satisfaction with two service models . In the first model , risk assessment was carried out using mailed family history data . Women estimated as being at high/moderate risk were offered an appointment at the familial breast cancer clinic , and those at low risk were sent a letter of reassurance . In the second model , all women were seen by a genetic nurse specialist , who assessed risk , referred high/moderate-risk women to the above clinic and discharged those at low risk . Over 60 % of all women in the study regarded access to breast screening by mammogram and regular check-ups as very important . This underlines the dem and for a multidisciplinary service providing both clinical genetic and surgical services . Satisfaction was high with both models of service , although significantly lower among women not at increased cancer risk and thus not offered a clinical check-up and mammography . Increased cancer worry was associated with a greater expressed need for information and for reassurance through follow-up clinical checks and mammography . Better targeting of counselling to the expressed concerns and needs of these women is required to improve the service offered . GPs and patients expressed no clear preference for any specific service location or staffing configuration . The novel community service was less expensive in terms of both staff and patient costs . The potential to decrease health staff/patient contact time and to employ nurse practitioners with both clinical genetic and oncology training should be explored further . The rapidly rising dem and for these services suggests that the evaluation of further new models needs to continue to be given priority to guide the development of cancer genetic services Purpose : Little is known about reasons why eligible breast cancer patients decline BRCA mutation testing . They may withdraw at different stages during genetic counseling for different reasons . We prospect ively studied perceived benefits and barriers to genetic counseling and BRCA testing in 102 newly diagnosed breast cancer patients approached for genetic counseling at the start of radiotherapy . Methods : Patients completed question naires and participated in interviews at different stages of the counseling protocol . Results : Participation was not influenced by distress , knowledge about hereditary breast cancer , previous genetic testing in relatives , or perceived risks and barriers . Immediate decliners ( n = 23 ) do not believe genetic testing is relevant for them . Patients who decline after pedigree compilation ( n = 14 ) are more hesitant and anxious about the influence of the test result on their future often wishing to postpone further testing . Late decliners ( n = 7 ) withdraw afraid of the test result and /or after a relative 's objection . These decliners are not easily identified upon approach because they are similar to patients who receive a DNA test result ( n = 58 ) . Notwithst and ing their decline , 81 % agreed to the timing or would have preferred an earlier approach for genetic counseling . Conclusion : Decliners may make more informed decisions after tailored health education , including adequate risk information Commercial marketing material s may serve as a source of information for physicians about genetic testing for inherited cancer susceptibility ( GTICS ) in addition to medical guidelines , continuing education , and journal articles . The primary purpose s of this study were to : ( 1 ) determine the percentage of physicians who received advertisements for GTICS early in the diffusion of commercial GTICS ( 1999–2000 ) ; ( 2 ) assess associated characteristics ; and ( 3 ) measure the perceived importance of commercial advertisements and promotions in physicians ' decisions to recommend testing to patients . A nationally representative , stratified r and om sample of 1,251 physicians from the American Medical Association ( AMA ) Physician Masterfile completed a 15–20 min mixed mode question naire that assessed specialty
Output:
| Generally there were modest positive effects on psychological outcomes such as worry and anxiety , behavioral outcomes have shown mixed results , and clinical outcomes were less well studied .
One systematic review , 1 r and omized controlled trial , and 14 other studies assessed consumer information needs and found in general that genetics knowledge was reported to be low but that attitudes were generally positive . |
MS212439 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Goals of workOur aim was to compare the effects of l and versus water multimodal exercise programs on body composition and breast cancer-specific quality of life in breast cancer survivors . Patients and methods Ninety-eight breast cancer survivors were assigned to three groups : control , l and exercise , and water exercise . Both exercise groups participated in an 8-week multimodal program . Adiposity was measured by anthropometry ( body mass index , waist circumference ) and bioelectrical impedance ( body fat and muscle lean body mass ) . Incidence of clinical ly significant secondary lymphedema was also assessed . Finally , specific quality of life was assessed using the European Organization for Research and Treatment of Cancer Quality of Life BR-23.Main Results Using ANCOVA , significant group × time interactions for body fat percentage ( F = 3.376 ; P = 0.011 ) and lean body mass ( F = 3.566 ; P = 0.008 ) were found . Breast cancer survivors in the l and exercise group exhibited a greater decrease in percentage of body fat than those in the water exercise ( P < 0.001 ) and control ( P = 0.002 ) groups . The ANCOVA revealed a significant group × time interaction for waist circumference ( F = 4.553 ; P = 0.002 ) : breast cancer survivors in the control group showed a greater waist circumference when compared to water ( P = 0.003 ) and l and ( P < 0.001 ) exercise groups . A significant group × time interaction was also found for breast symptoms ( F = 9.048 ; P < 0.001 ) : participants in the water exercise group experienced a greater decrease of breast symptoms than those in the l and exercise ( P < 0.01 ) and control ( P < 0.05 ) groups . Conclusion L and exercise produced a greater decrease in body fat and an increase in lean body mass , whereas water exercise was better for improving breast symptoms Few r and omized controlled trials have examined the effects of combined aerobic and resistance training in breast cancer survivors soon after completing adjuvant therapy . Breast cancer survivors ( N = 58 ) within 2 years of completing adjuvant therapy were r and omly assigned to an immediate exercise group ( IEG ; n = 29 ) or a delayed exercise group ( DEG ; n = 29 ) . The IEG completed 12 weeks of supervised aerobic and resistance exercise , three times per week . The DEG completed the program during the next 12 weeks . Participants completed patient-rated outcomes at baseline , 6 , 12 , 18 and 24 weeks . The primary endpoint was overall quality of life ( QoL ) measured by the Functional Assessment of Cancer Therapy-Breast scale . Secondary endpoints were fatigue , social physique anxiety , and physical fitness . Follow-up data was obtained on 97 % of participants and exercise adherence was 61.3 % . Repeated measures analyses of variance revealed a significant group by time interaction for overall QoL ( P < 0.001 ) . Specifically , QoL increased in the IEG from baseline to 12 weeks by 20.8 points compared to a decrease in the DEG of 5.3 points ( mean group difference = 26.1 ; 95 % CI = 18.3–32.7 ; P < 0.001 ) . From 12 to 24 weeks , QoL increased in the DEG by 29.5 points compared to an increase of 6.5 points in the IEG ( mean group difference = 23.0 ; 95 % CI = 16.3–29.1 ; P < 0.001 ) . Similar results were obtained for the secondary endpoints . Combined aerobic and resistance exercise soon after the completion of breast cancer therapy produces large and rapid improvements in health-related outcomes This pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS Boston University Patricia Cortes Harvard University Claudia Goldin Swarthmore College Jennifer The aim of this study was to determine whether an exercise program , commencing 4–6 weeks post-operatively , reduces upper limb impairments in women treated for early breast cancer . Women ( n = 160 ) were r and omized to either an 8-week exercise program ( n = 81 ) or to a control group ( n = 79 ) following stratification for axillary surgery . The exercise program comprised a weekly session and home program of passive stretching and progressive resistance training for shoulder muscles . The control group attended fortnightly assessment s but no exercises were provided . The primary outcome was self-reported arm symptoms derived from the EORTC breast cancer-specific question naire ( BR23 ) , scored out of 100 with a low score indicative of fewer symptoms . The secondary outcomes included physical measures of shoulder range of motion , strength , and swelling ( i.e. , lymphedema ) . Women were assessed immediately following the intervention and at 6 months post-intervention . The change in symptoms from baseline was not significantly different between groups immediately following the intervention or at 6 m post-intervention . The between group difference immediately following the intervention was 4 ( 95 % CI −1 to 9 ) and 6 months post-intervention was 4 ( −2 to 10 ) . However , the change in range of motion for flexion and abduction was significantly greater in the exercise group immediately following the intervention , as was change in shoulder abductor strength . In conclusion , a supervised exercise program provided some , albeit small , additional benefit at 6 months post-intervention to women who had been provided with written information and reminders to use their arm . Both the groups reported few impairments including swelling immediately following the intervention and 6 months post-intervention . Notably , resistance training in the post-operative period did not precipitate lymphedema OBJECTIVES This study compares the effects of an integrated yoga program with brief supportive therapy in breast cancer out patients undergoing adjuvant radiotherapy at a cancer centre . METHODS Eighty-eight stage II and III breast cancer out patients were r and omly assigned to receive yoga ( n = 44 ) or brief supportive therapy ( n = 44 ) prior to their radiotherapy treatment . Intervention consisted of yoga sessions lasting 60 min daily while the control group was imparted supportive therapy once in 10 days . Assessment s included European Organization for Research in the Treatment of Cancer- Quality of Life ( EORTCQoL C30 ) functional scales and Positive and Negative Affect Schedule ( PANAS ) . Assessment s were done at baseline and after 6 weeks of radiotherapy treatment . RESULTS An intention to treat GLM repeated measures ANOVA showed significant difference across groups over time for positive affect , negative affect and emotional function and social function . There was significant improvement in positive affect ( ES = 0.59 , p = 0.007 , 95%CI 1.25 to 7.8 ) , emotional function ( ES = 0.71 , p = 0.001 , 95%CI 6.45 to 25.33 ) and cognitive function ( ES = 0.48 , p = 0.03 , 95%CI 1.2 to 18.5 ) , and decrease in negative affect ( ES = 0.84 , p<0.001 , 95%CI -13.4 to -4.4 ) in the yoga group as compared to controls . There was a significant positive correlation between positive affect with role function , social function and global quality of life . There was a significant negative correlation between negative affect with physical function , role function , emotional function and social function . CONCLUSION The results suggest a possible role for yoga to improve quality of life and affect in breast cancer out patients BACKGROUND Exercise has been reported to decrease cancer-related fatigue and to increase quality of life ( QoL ) in various breast cancer ( BC ) population s. However , studies investigating exercise during radiotherapy or resistance training are scarce . We conducted a r and omized , controlled trial ( BEST study ) to assess the efficacy of 12-week resistance training on fatigue beyond possible psychosocial effects of a group-based intervention . PATIENTS AND METHODS One hundred sixty patients with BC stage 0-III were r and omly assigned to a 12-week progressive resistance training ( 2 times/week ) or a 12-week relaxation control ( RC , 2 times/week ) . Both interventions were group-based . The primary end point fatigue was assessed with a 20-item multidimensional question naire , QoL with EORTC question naires . Statistical analyses were based on analysis of covariance models for the individual changes from baseline to week 13 . RESULTS Adherence to the intervention program as well as the completion rate ( 97 % ) for the primary outcome variable fatigue was high . In intention-to-treat analyses for the N = 155 patients , significant between-group mean differences ( MD ) favoring the exercise group ( EX ) were observed for general fatigue ( P = 0.044 ) , especially for the subscale physical fatigue [ MD = -0.8 ; 95 % confidence interval -1.5 to -0.2 , P = 0.013 ] , but not for affective ( P = 0.91 ) or cognitive fatigue ( P = 0.65 ) . For QoL , significantly larger improvements regarding the role function ( P = 0.035 ) and pain ( P = 0.040 ) were noted among exercisers compared with RCs . Future perspective improved significantly stronger in the RC group compared with the EX group ( P = 0.047 ) . CONCLUSIONS The 12-week resistance training program was a safe , feasible and efficacious strategy to improve cancer-related fatigue and components of QoL in BC patients during adjuvant radiotherapy . As exercise was compared with another group-based intervention , results indicate that resistance training effects on fatigue and QoL go beyond psychosocial benefits , and that the clinical ly relevant overall benefit of resistance exercise compared with usual care can be assumed to be higher . TRIAL REGISTRATION Clinical Trials.gov NCT01468766 Background Secondary arm lymphoedema continues to affect at least 20 % of women after treatment for breast cancer requiring lifelong professional treatment and self-management . The holistic practice of yoga may offer benefits as an adjunct self-management option . The aim of this small pilot trial was to gain preliminary data to determine the effect of yoga on women with stage one breast cancer-related lymphoedema ( BCRL ) . This paper reports the results for the primary and secondary outcomes . Methods Participants were r and omised , after baseline testing , to receive either an 8-week yoga intervention ( n = 15 ) , consisting of a weekly 90-minute teacher-led class and a 40-minute daily session delivered by DVD , or to a usual care wait-listed control group ( n = 13 ) . Primary outcome measures were : arm volume of lymphoedema measured by circumference and extra-cellular fluid measured by bioimpedance spectroscopy . Secondary outcome measures were : tissue in duration measured by tonometry ; levels of sensations , pain , fatigue , and their limiting effects all measured by a visual analogue scale ( VAS ) and quality of life based on the Lymphoedema Quality of Life Tool ( LYMQOL ) . Measurements were conducted at baseline , week 8 ( post-intervention ) and week 12 ( four weeks after cessation of the intervention ) . Results At week 8 , the intervention group had a greater decrease in tissue in duration of the affected upper arm compared to the control group ( p = 0.050 ) , as well as a greater reduction in the symptom sub-scale for QOL ( p = 0.038 ) . There was no difference in arm volume of lymphoedema or extra-cellular fluid between groups at week 8 ; however , at week 12 , arm volume increased more for the intervention group than the control group ( p = 0.032 ) . Conclusions An 8-week yoga intervention reduced tissue in duration of the affected upper arm and decreased the QOL sub-scale of symptoms . Arm volume of lymphoedema and extra-cellular fluid did not increase . These benefits did not last on cessation of the intervention when arm volume of lymphoedema increased . Further research trials with a longer duration , higher levels of lymphoedema and larger numbers are warranted before definitive conclusions can be made Exercise for Health was a r and omized , controlled trial design ed to evaluate two modes of delivering ( face-to-face [ FtF ] and over-the-telephone [ Tel ] ) an 8-month translational exercise intervention , commencing 6-weeks post-breast cancer surgery ( PS ) . Outcomes included quality of life ( QoL ) , function ( fitness and upper body ) and treatment-related side effects ( fatigue , lymphoedema , body mass index , menopausal symptoms , anxiety , depression and pain ) . Generalised estimating equation modelling determined time ( baseline [ 5 weeks PS ] , mid-intervention [ 6 months PS ] , post-intervention [ 12 months PS ] ) , group ( FtF , Tel , Usual Care [ UC ] ) and time-by-group effects . 194 women representative of the breast cancer population were r and omised to the FtF ( n = 67 ) , Tel ( n = 67 ) and UC ( n = 60 ) groups . There were significant ( p < 0.
Output:
| All three modes of exercise intervention showed a significant effect on quality of life between groups .
Conclusions Exercise is a safe and effective method of improving the quality of life in patients with breast cancer .
In particular , combined training was associated with a significant improvement in quality of life . |
MS212440 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Background Decreased pain represents a clinical ly important outcome following arthroscopic knee surgery . However , little is known about preoperative mood and attitudinal factors and their potential relationship with pain outcomes . Purpose This prospect i ve , longitudinal study investigated the influence of preoperative depression , stress , and optimism on pain severity and interference with functioning , controlling for relevant demographic and clinical factors 1 year postoperatively . Methods Participants ( N = 180 , mean age = 48.2 years ) completed scales assessing pain severity and interference both preoperatively and postoperatively . Demographics , depression , stress , optimism , and body mass index were assessed preoperatively . Physicians assessed extent of knee osteoarthritis during surgery . Results Hierarchical regression analyses controlling for relevant demographic and clinical variables revealed that optimism and stress were significant predictors of pain severity at 1 year but not pain interference . Extent of osteoarthritis predicted pain interference . Conclusions These findings support that optimism and stress are important predictors of patient-rated pain severity . They do not , however , predict the extent to which pain interferes with daily functioning Abstract Background Chronic pain is associated with emotional problems as well as difficulties in cognitive functioning . Prior experimental studies have shown that optimism , the tendency to expect that good things happen in the future , and positive emotions can counteract pain‐induced task performance deficits in healthy participants . More specifically , induced optimism was found to buffer against the negative effects of experimental pain on executive functioning . This clinical experiment examined whether this beneficial effect can be extended to a chronic pain population . Methods Patients ( N = 122 ) were r and omized to a positive psychology Internet‐based intervention ( PPI ; n = 74 ) or a waiting list control condition ( WLC ; n = 48 ) . The PPI consisted of positive psychology exercises that particularly target optimism , positive emotions and self‐compassion . Results Results demonstrated that patients in the PPI condition scored higher on happiness , optimism , positive future expectancies , positive affect , self‐compassion and ability to live a desired life despite pain , and scored lower on pain catastrophizing , depression and anxiety compared to patients in the WLC condition . However , executive task performance did not improve following completion of the PPI , compared to the WLC condition . Conclusions Despite the lack of evidence that positive emotions and optimism can improve executive task performance in chronic pain patients , this study did convincingly demonstrate that it is possible to increase positive emotions and optimism in chronic pain patients with an online positive psychology intervention . It is imperative to further explore amendable psychological factors that may reduce the negative impact of pain on executive functioning . Significance We demonstrated that an Internet‐based positive psychology intervention strengthens optimism and positive emotions in chronic pain patients . These emotional improvements are not associated with improved executive task performance . As pain itself often can not be relieved , it is imperative to have techniques to reduce the burden of living with chronic pain Objectives : To assess the contribution of important psychological re sources ( i.e. optimism , pessimism , control beliefs ) to the psychological well-being of older adults with Osteoarthritis ( OA ) ; to assess the direct and mediated association of these psychosocial re sources to outcomes ( depressive symptoms , life satisfaction , and self-esteem ) . These objectives are important because OA is a significant stressor , treatments are limited , and psychological functioning is at risk for those coping with the condition , even compared to other chronic illnesses . Method : A cross-sectional survey of 160 community-dwelling older adults with OA ( 81 % women ) . Participants were not r and omly selected , but nonetheless reflected the demographic makeup of the selection area . Results : Ordinary least squares regression analyses using the PROCESS macro revealed that optimism and pessimism were associated with higher depressive symptoms and lower self-esteem indirectly through constraints beliefs . The analysis of life satisfaction showed that optimism and pessimism were each partially mediated through mastery and constraints beliefs . Discussion : These results suggest that prior research , which has assessed these psychological re sources as having singular relationships to outcomes , may have underestimated the importance of the relationship between these variables . We discuss possible points of intervention for older adults with OA who may experience increasing constraints beliefs over time Background : Few epidemiological studies have prospect ively investigated preoperative and surgical risk factors for acute postoperative pain after surgery for breast cancer . We investigated demographic , psychological , pain-related and surgical risk factors in women undergoing resectional surgery for breast cancer . Methods : Primary outcomes were pain severity , at rest ( PAR ) and movement-evoked pain ( MEP ) , in the first postoperative week . Results : In 338 women undergoing surgery , those with chronic preoperative pain were three times more likely to report moderate to severe MEP after breast cancer surgery ( OR 3.18 , 95 % CI 1.45–6.99 ) . Increased psychological ‘ robustness ’ , a composite variable representing positive affect and dispositional optimism , was associated with lower intensity acute postoperative PAR ( OR 0.63 , 95 % CI 0.48–0.82 ) and MEP ( OR 0.71 , 95 % CI 0.54–0.93 ) . Sentinel lymph node biopsy ( SLNB ) and intraoperative nerve division were associated with reduced postoperative pain . No relationship was found between preoperative neuropathic pain and acute pain outcomes ; altered sensations and numbness postoperatively were more common after axillary sample or clearance compared with SLNB . Conclusion : Chronic preoperative pain , axillary surgery and psychological robustness significantly predicted acute pain outcomes after surgery for breast cancer . Preoperative identification and targeted intervention of subgroups at risk could enhance the recovery trajectory in cancer survivors • STUDY DESIGN : Secondary analysis of prospect ively collected data . • BACKGROUND : An abundance of evidence has highlighted the influence of pain catastrophizing and fear avoidance on clinical outcomes . Less is known about the interaction of positive psychological re sources with these pain‐associated distress factors . • OBJECTIVE : To assess whether optimism moderates the influence of pain catastrophizing and fear avoidance on 3‐month clinical outcomes in patients with shoulder pain . • METHODS : Data from 63 individuals with shoulder pain ( mean ± SD age , 38.8 ± 14.9 years ; 30 female ) were examined . Demographic , psychological , and clinical characteristics were obtained at baseline . Vali date d measures were used to assess optimism ( Life Orientation Test‐Revised ) , pain catastrophizing ( Pain Catastrophizing Scale ) , fear avoidance ( Fear‐Avoidance Beliefs Question naire physical activity subscale ) , shoulder pain intensity ( Brief Pain Inventory ) , and shoulder function ( Pennsylvania Shoulder Score function subscale ) . Shoulder pain and function were reassessed at 3 months . Regression models assessed the influence of ( 1 ) pain catastrophizing and optimism and ( 2 ) fear avoidance and optimism . The final multivariable models controlled for factors of age , sex , education , and baseline scores , and included 3‐month pain intensity and function as separate dependent variables . • RESULTS : Shoulder pain ( mean difference , ‐1.6 ; 95 % confidence interval [ CI ] : ‐2.1 , ‐1.2 ) and function ( mean difference , 2.4 ; 95 % CI : 0.3 , 4.4 ) improved over 3 months . In multivariable analyses , there was an interaction between pain catastrophizing and optimism ( & bgr ; = 0.19 ; 95 % CI : 0.02 , 0.35 ) for predicting 3‐month shoulder function ( F = 16.8 , R2 = 0.69 , P<.001 ) , but not pain ( P = .213 ) . Further examination of the interaction with the Johnson‐Neyman technique showed that higher levels of optimism lessened the influence of pain catastrophizing on function . There was no evidence of significant moderation of fear‐avoidance beliefs for 3‐month shoulder pain ( P = .090 ) or function ( P = .092 ) . • CONCLUSION : Optimism decreased the negative influence of pain catastrophizing on shoulder function , but not pain intensity . Optimism did not alter the influence of fear‐avoidance beliefs on these outcomes . • LEVEL OF EVIDENCE : Prognosis , level 2b BACKGROUND Major depression is known to be related to higher cardiovascular mortality . However , epidemiological data regarding dispositional optimism in relation to mortality are scanty . OBJECTIVE To test whether subjects who are optimistic live longer than those who are pessimistic . DESIGN Our analysis formed part of a prospect i ve population -based cohort study in the Netherl and s ( Arnhem Elderly Study ) . SETTING General community . PARTICIPANTS Elderly subjects aged 65 to 85 years ( 999 men and women ) completed the 30-item vali date d Dutch Scale of Subjective Well-being for Older Persons , with 5 subscales : health , self-respect , morale , optimism , and contacts . A total of 941 subjects ( 466 men and 475 women ) had complete dispositional optimism data , and these subjects were divided into quartiles . MAIN OUTCOME MEASURE Number of deaths during the follow-up period . RESULTS During the follow-up period of 9.1 years ( 1991 - 2001 ) , there were 397 deaths . Compared with subjects with a high level of pessimism , those reporting a high level of optimism had an age- and sex-adjusted hazard ratio of 0.55 ( 95 % confidence interval , 0.42 - 0.74 ; upper vs lower quartile ) for all-cause mortality . For cardiovascular mortality , the hazard ratio was 0.23 ( 95 % confidence interval , 0.10 - 0.55 ) when adjusted for age , sex , chronic disease , education , smoking , alcohol consumption , history of cardiovascular disease or hypertension , body mass index , and total cholesterol level . Protective trend relationships were observed between the level of optimism and all-cause and cardiovascular mortality ( P<.001 and P = .001 for trend , respectively ) . Interaction with sex ( P = .04 ) supported a stronger protective effect of optimism in men than women for all-cause mortality but not for cardiovascular mortality . CONCLUSIONS Our results provide support for a grade d and independent protective relationship between dispositional optimism and all-cause mortality in old age . Prevention of cardiovascular mortality accounted for much of the effect A proportion of patients do not recover fully from surgery or they develop chronic postsurgical pain . The aim of this study was to examine the incidence and predictors of unfavourable long‐term outcome after surgery using a prospect i ve cohort design Objectives : In 2009 , Gramke and colleagues have described predictive factors to preoperatively detect those at risk for moderate to severe acute postsurgical pain ( APSP ) after day surgery . The aim of the present study is to externally vali date this initial model and to improve and internally vali date a modified version of this model . Material s and Methods : Elective patients scheduled for day surgery were prospect ively enrolled from November 2008 to April 2010 . Model discrimination was quantified using the area under the receiver operating characteristic curve ( AUC ) . Model calibration was assessed by visual inspection of the calibration plot . Subsequently , we modified ( different assignment of type of surgery , different cutoff for moderate to severe APSP , continuous of dichotomized variables and testing of additional variables ) and internally vali date d this model by st and ard bootstrapping techniques . Results : A total of 1118 patients were included . The AUC for the original model was 0.81 in the derivation data set and 0.72 in our validation data set . The model showed poorly calibrated risk predictions . The AUC of the modified model was 0.82 ( optimism-corrected AUC=0.78 ) . This modified model showed good calibration . Conclusions : The original prediction model of Gramke and colleagues performed insufficiently on our cohort of out patients with respect to discrimination and calibration . Internal validation of a modified model shows promising results . In this model , preoperative pain , patient derived expected pain , and different types of surgery are the strongest predictors of moderate to severe APSP after day surgery Objective : To identify somatic and psychologic predictors of pain , functional limitations , global perceived recovery , and quality of life 6 months after surgical intervention . Summary Background Data : Recent studies have indicated that chronic pain after surgical intervention is more common than previously assumed . Several demographic and somatic predictors of long-term unfavorable outcome have been identified , but little is known about the contribution of psychologic risk factors . Methods : A prospect i ve cohort study , including 625 patients undergoing elective surgery at the University Hospital Maastricht , The Netherl and s , was conducted between February and August 2003 . Psychologic question naires were completed preoperatively and acute postoperative pain was recorded until 4 days after the operation . Six months later , all patients received follow-up question naires to assess pain , functional limitations , global perceived recovery , and quality of life . Multivariable logistic regression analyses were used to estimate relative risk of poor outcome in terms of pain , functional limitations , and global recovery . Multivariable linear regression analysis was used to assess associations with quality of life at 6 months . Results : The most important somatic predictors of unfavorable outcome were duration of the operation and high levels of acute postoperative pain . Patients reporting high levels of pain 4 days after the operation and patients undergoing an operation of longer than 3 hours were at risk for increased pain , increased functional limitations , poor global recovery , and reported lower levels of quality of life 6 months after the operation . Psychologic variables that influenced long-term outcome were preoperative fear of surgery and optimism . Fear of the long-term consequences of the operation was associated with more pain
Output:
| The review suggests that optimism is associated with less acute and chronic pain , especially since a higher percentage of beneficial associations was found with high study /publication quality and with the primary focus on this relationship . |
MS212441 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND In the phase 3 RADIANT-4 trial , everolimus increased progression-free survival compared with placebo in patients with advanced , progressive , non-functional , well-differentiated gastrointestinal or lung neuroendocrine tumours ( NETs ) . We now report the health-related quality of life ( HRQOL ) secondary endpoint . METHODS RADIANT-4 is a multicentre , r and omised , double-blind , placebo-controlled , phase 3 trial done in 97 centres in 25 countries worldwide . Adults ( aged ≥18 years ) were eligible for the study if they had pathologically confirmed , advanced ( unresectable or metastatic ) , non-functional , well-differentiated ( grade 1 or 2 ) NETs of lung or gastrointestinal origin . Patients were r and omly allocated ( 2:1 ) using block r and omisation ( block size of three ) by an interactive voice response system to receive oral everolimus ( 10 mg per day ) or placebo , both with best supportive care , with stratification by tumour origin , WHO performance status , and previous somatostatin analogue treatment . HRQOL was assessed with the Functional Assessment of Cancer Therapy-General ( FACT-G ) question naire at baseline ( visit 2 , day 1 ) , every 8 weeks ( ± 1 week ) during the study for the first 12 months after r and omisation , and every 12 weeks thereafter until study drug discontinuation . The primary endpoint , reported previously , was progression-free survival assessed by central review ; HRQOL was a prespecified secondary endpoint . The prespecified secondary outcome measure was time to definitive deterioration ( ≥7 points ) in FACT-G total score . Analyses were done on the full analysis set , consisting of all r and omised patients , by intention to treat . Only data obtained while receiving the r and omly allocated treatment were included in this analysis . Enrolment for RADIANT-4 was completed on Aug 23 , 2013 , but the trial is ongoing pending final analysis of the key secondary endpoint of overall survival . This trial is registered with Clinical Trials.gov , number NCT01524783 . FINDINGS Between April 3 , 2012 , and Aug 23 , 2013 , 302 patients were enrolled ; 205 were r and omly allocated everolimus and 97 were assigned placebo . At baseline , 193 ( 94 % ) of 205 patients assigned everolimus and 95 ( 98 % ) of 97 allocated placebo had completed either fully or partly the FACT-G question naire ; at week 48 , 70 ( 83 % ) of 84 patients assigned everolimus and 22 ( 85 % ) of 26 allocated placebo completed FACT-G. Median time to definitive deterioration in FACT-G total score was 11·27 months ( 95 % CI 9·27 - 19·35 ) with everolimus and 9·23 months ( 5·52-not estimable ) with placebo ( adjusted hazard ratio 0·81 , 95 % CI 0·55 - 1·21 ; log-rank p=0·31 ) . INTERPRETATION HRQOL was maintained for patients with advanced , non-functional , gastrointestinal or lung NETs , with no relevant differences noted between the everolimus and placebo groups . In view of the previous RADIANT-4 findings of longer progression-free survival with everolimus , our findings suggest that everolimus delays disease progression while preserving overall HRQOL , even with the usual toxic effects related to active targeted drug treatment for cancer . FUNDING Novartis Pharmaceuticals Purpose Treatment options for neuroendocrine tumors ( NETs ) remain limited . This trial assessed the progression-free survival ( PFS ) of bevacizumab or interferon alfa-2b ( IFN-α-2b ) added to octreotide among patients with advanced NETs . Patients and Methods Southwest Oncology Group ( SWOG ) S0518 , a phase III study conducted in a US cooperative group system , enrolled patients with advanced grade s 1 and 2 NETs with progressive disease or other poor prognostic features . Patients were r and omly assigned to treatment with octreotide LAR 20 mg every 21 days with either bevacizumab 15 mg/kg every 21 days or 5 million units of IFN-α-2b three times per week . The primary end point was central ly assessed PFS . This trial is registered with Clinical Trials.gov as NCT00569127 . Results A total of 427 patients was enrolled , of whom 214 were allocated to bevacizumab and 213 to IFN-α-2b . The median PFS by central review was 16.6 months ( 95 % CI , 12.9 to 19.6 months ) in the bevacizumab arm and was 15.4 months ( 95 % CI , 9.6 to 18.6 months ) in the IFN arm ( hazard ratio [ HR ] , 0.93 ; 95 % CI , 0.73 to 1.18 ; P = .55 ) . By site review , the median PFS times were 15.4 months ( 95 % CI , 12.6 to 17.2 months ) for bevacizumab and 10.6 months ( 95 % CI , 8.5 to 14.4 months ) for interferon ( HR , 0.90 ; 95 % CI , 0.72 to 1.12 ; P = .33 ) . Time to treatment failure was longer with bevacizumab than with IFN ( HR , 0.72 ; 95 % CI , 0.58 to 0.89 ; P = .003 ) . Confirmed radiologic response rates were 12 % ( 95 % CI , 8 % to 18 % ) for bevacizumab and 4 % ( 95 % CI , 2 % to 8 % ) for IFN . Common adverse events with bevacizumab and octreotide included hypertension ( 32 % ) , proteinuria ( 9 % ) , and fatigue ( 7 % ) ; with IFN and octreotide , they included fatigue ( 27 % ) , neutropenia ( 12 % ) , and nausea ( 6 % ) . Conclusion No significant differences in PFS were observed between the bevacizumab and IFN arms , which suggests that these agents have similar antitumor activity among patients with advanced NETs PURPOSE Effective systemic therapy for advanced carcinoid is lacking . The combination of bevacizumab ( BEV ) and pegylated ( PEG ) interferon alpha-2b was evaluated among patients with metastatic or unresectable carcinoid tumors . PATIENTS AND METHODS Forty-four patients on stable doses of octreotide were r and omly assigned to 18 weeks of treatment with bevacizumab or PEG interferon alpha-2b . At disease progression ( PD ) or at the end of 18 weeks ( whichever occurred earlier ) , patients received bevacizumab plus PEG interferon until progression . Functional computer tomography ( CT ) scans were performed to measure effect on tumor blood flow . RESULTS In the bevacizumab arm , four patients ( 18 % ) achieved confirmed partial response ( PR ) , 17 patients ( 77 % ) had stable disease ( SD ) , and one patient ( 5 % ) had PD . In the PEG interferon arm , 15 patients ( 68 % ) had SD and six patients ( 27 % ) had PD . Progression-free survival ( PFS ) rates after 18 weeks of monotherapy were 95 % in bevacizumab versus 68 % on the PEG interferon arm . The overall median PFS for all 44 patients is 63 weeks . Compared with paired baseline measurements on functional CT scans , we observed a 49 % ( P < .01 ) and 28 % ( P < .01 ) decrease in tumor blood flow at day 2 and week 18 among patients treated with bevacizumab . No significant changes in tumor blood flow were observed following PEG interferon . PEG interferon alpha-2b treatment was associated with decrease in plasma basic fibroblast growth factor ( bFGF ; P = .04 ) and increase in plasma interleukin-18 ( IL-18 ; P < .01 ) . No significant changes in bFGF or IL-18 following treatment with bevacizumab were observed . CONCLUSION Bevacizumab therapy result ed in objective responses , reduction of tumor blood flow , and longer PFS in patients with carcinoid than PEG interferon treatment These guidelines up date previous guidance published in 2005 . They have been revised by a group who are members of the UK and Irel and Neuroendocrine Tumour Society with endorsement from the clinical committees of the British Society of Gastroenterology , the Society for Endocrinology , the Association of Surgeons of Great Britain and Irel and ( and its Surgical Specialty Associations ) , the British Society of Gastrointestinal and Abdominal Radiology and others . The authors hip represents leaders of the various groups in the UK and Irel and Neuroendocrine Tumour Society , but a large amount of work has been carried out by other specialists , many of whom attended a guidelines conference in May 2009 . We have attempted to represent this work in the acknowledgements section . Over the past few years , there have been advances in the management of neuroendocrine tumours , which have included clearer characterisation , more specific and therapeutically relevant diagnosis , and improved treatments . However , there remain few r and omised trials in the field and the disease is uncommon , hence all evidence must be considered weak in comparison with other more common cancers . BACKGROUND The combination of streptozocin and fluorouracil has become the st and ard therapy for advanced islet-cell carcinoma . However , doxorubicin has also been shown to be active against this type of tumor , as has chlorozotocin , a drug that is structurally similar to streptozocin but less frequently causes vomiting . METHODS In this multicenter trial , we r and omly assigned 105 patients with advanced islet-cell carcinoma to receive one of three treatment regimens : streptozocin plus fluorouracil , streptozocin plus doxorubicin , or chlorozotocin alone . The 31 patients in whom the disease did not respond to treatment were crossed over to chlorozotocin alone or to one of the combination regimens . RESULTS Streptozocin plus doxorubicin was superior to streptozocin plus fluorouracil in terms of the rate of tumor regression , measured objective ly ( 69 percent vs. 45 percent , P = 0.05 ) , and the length of time to tumor progression ( median , 20 vs. 6.9 months ; P = 0.001 ) . Streptozocin plus doxorubicin also had a significant advantage in terms of survival ( median , 2.2 vs. 1.4 years ; P = 0.004 ) that was accentuated when we considered long-term survival ( greater than 2 years ) . Chlorozotocin alone produced a 30 percent regression rate , with the length of time to tumor progression and the survival time equivalent to those observed with streptozocin plus fluorouracil . Crossover therapy after the failure of either chlorozotocin alone or one of the combination regimens produced an overall response rate of only 17 percent , and the responses were transient . Toxic reactions to all regimens included vomiting , which was least severe with chlorozotocin ; hematologic depression ; and , with long-term therapy , renal insufficiency . CONCLUSIONS The combination of streptozocin and doxorubicin is superior to the current st and ard regimen of streptozocin plus fluorouracil in the treatment of advanced islet-cell carcinoma . Chlorozotocin alone is similar in efficacy to streptozocin plus fluorouracil , but it produces fewer gastrointestinal side effects than the regimens containing streptozocin . It therefore merits study as a constituent of combination drug regimens BACKGROUND Effective systemic therapies for patients with advanced , progressive neuroendocrine tumours of the lung or gastrointestinal tract are scarce . We aim ed to assess the efficacy and safety of everolimus compared with placebo in this patient population . METHODS In the r and omised , double-blind , placebo-controlled , phase 3 RADIANT-4 trial , adult patients ( aged ≥18 years ) with advanced , progressive , well-differentiated , non-functional neuroendocrine tumours of lung or gastrointestinal origin were enrolled from 97 centres in 25 countries worldwide . Eligible patients were r and omly assigned in a 2:1 ratio by an interactive voice response system to receive everolimus 10 mg per day orally or identical placebo , both with supportive care . Patients were stratified by tumour origin , performance status , and previous somatostatin analogue treatment . Patients , investigators , and the study sponsor were masked to treatment assignment . The primary endpoint was progression-free survival assessed by central radiology review , analysed by intention to treat . Overall survival was a key secondary endpoint . This trial is registered with Clinical Trials.gov , number NCT01524783 . FINDINGS Between April 3 , 2012 , and Aug 23 , 2013 , a total of
Output:
| Conclusions and Relevance The findings from this study suggest that a range of efficient therapies with different safety profiles is available for patients with NETs |
MS212442 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: A reduction in salt intake lowers blood pressure . However , most previous trials were in whites with few in blacks and Asians . Salt reduction may also reduce other cardiovascular risk factors ( eg , urinary albumin excretion , arterial stiffness ) . However , few well-controlled trials have studied these effects . We carried out a r and omized double-blind crossover trial of salt restriction with slow sodium or placebo , each for 6 weeks , in 71 whites , 69 blacks , and 29 Asians with untreated mildly raised blood pressure . From slow sodium to placebo , urinary sodium was reduced from 165±58 ( ±SD ) to 110±49 mmol/24 hours ( 9.7 to 6.5 g/d salt ) . With this reduction in salt intake , there was a significant decrease in blood pressure from 146±13/91±8 to 141±12/88±9 mm Hg ( P<0.001 ) , urinary albumin from 10.2 ( IQR : 6.8 to 18.9 ) to 9.1 ( 6.6 to 14.0 ) mg/24 hours ( P<0.001 ) , albumin/creatinine ratio from 0.81 ( 0.47 to 1.43 ) to 0.66 ( 0.44 to 1.22 ) mg/mmol ( P<0.001 ) , and carotid-femoral pulse wave velocity from 11.5±2.3 to 11.1±1.9 m/s ( P<0.01 ) . Subgroup analysis showed that the reductions in blood pressure and urinary albumin/creatinine ratio were significant in all groups , and the decrease in pulse wave velocity was significant in blacks only . These results demonstrate that a modest reduction in salt intake , approximately the amount of the current public health recommendations , causes significant falls in blood pressure in all 3 ethnic groups . Furthermore , it reduces urinary albumin and improves large artery compliance . Although both could be attributable to the falls in blood pressure , they may carry additional benefits on reducing cardiovascular disease above that obtained from the blood pressure falls alone Objective — To study the possible pathophysiological implication s of long continued dietary sodium restriction in pregnancy Objective : To determine the blood pressure responses in elderly normotensive men and women to dietary sodium and to the diunsaturated fatty acid dihomogammalinolenic acid ( DGLA ) , which is derived from linoleic acid Design : Blood pressure responses were assessed in 66 subjects ( 36 male , 30 female ; mean age 65 years ) on two diets differing by approximately 70mmol/day sodium , combined with daily supplements of either 1 g DGLA or 1 g safflower oil , giving a four-group parallel design . After a common period of salt restriction and salt supplementation , two sets of parallel groups continued with either salt or placebo tablets . The study was blinded , except for dietary adjustments based on 24-h urinary sodium excretion values measured once every 2 weeks . Blood pressures were also measured automatically once every 2 weeks Results : Urinary sodium excretion ( sodium intake ) correlated significantly with systolic and diastolic blood pressures . A strong interaction with sex ( P < 0.001 for systolic blood pressure ) reflected greater responsiveness in women to changing sodium intake . A second major determinant of blood pressure responsiveness was the waist : hip ratio , an index of central obesity ; this correlation was independent of the initial sodium intake , initial blood pressure or body mass index . The waist : hip ratio was a powerful predictor of blood pressure changes with sodium intake in women only ; women with and roid fat distribution were , similarly to men , less sensitive to dietary sodium . Daily supplements of 1 g DGLA doubled the concentration of DGLA in plasma but did not influence blood pressure Conclusions : Among elderly normotensive subjects , women responded to changes in sodium intake with greater changes in blood pressure than men did . Furthermore , this response was strongly related to the gynaecoid distribution of body The aim of this study was to determine whether moderate restriction of dietary salt intake leads to an additional fall in blood pressure in treated hypertensive men who are asked to simultaneously reduce their usual alcohol intake . Sixty-three subjects entered an initial 2-week familiarization period during which they continued their usual alcohol intake and commenced a " low sodium " diet ( less than 60 mmol/day ) supplemented with 100 mmol sodium chloride per day as enteric-coated tablets . Subjects were then r and omly assigned to either drink a low alcohol beer alone for a 4-week period ( reducing their self-reported alcohol consumption from 537 to 57 ml/week ) or to continue their usual alcohol intake ( 543 versus 557 ml/week ) . Within the low and normal alcohol intake groups , subjects were assigned to either a low or normal sodium intake . The low sodium groups continued the sodium-restricted diet but were switched to placebo sodium chloride tablets for the 4 weeks . This result ed in a fall in the 24-hour urinary sodium excretion from 144 to 69 mmol/day . The normal sodium groups continued the low sodium diet but kept taking 100 mmol/day of the sodium chloride tablets , and their urinary sodium excretion remained unchanged ( 125 versus 142 mmol/day ) . Regular antihypertensive therapy was continued throughout . Fifty-nine subjects completed the trial . In those who reduced their alcohol intake there was a fall in both systolic blood pressure ( -5.4 mm Hg supine , p less than 0.01 ) and diastolic blood pressure ( -3.2 mm Hg supine , p less than 0.01 ) . ( ABSTRACT TRUNCATED AT 250 WORDS This study was design ed to evaluate in healthy volunteers the renal hemodynamic and tubular effects of the orally active angiotensin II receptor antagonist losartan ( DuP 753 or MK 954 ) . Losartan or a placebo was administered to 23 subjects maintained on a high-sodium ( 200 mmol/d ) or a low-sodium ( 50 mmol/d ) diet in a r and omized , double-blind , crossover study . The two 6-day diet periods were separated by a 5-day washout period . On day 6 , the subjects were water loaded , and blood pressure , renal hemodynamics , and urinary electrolyte excretion were measured for 6 hours after a single 100-mg oral dose of losartan ( n = 16 ) or placebo ( n = 7 ) . Losartan induced no significant changes in blood pressure , glomerular filtration rate , or renal blood flow in these water-loaded subjects , whatever the sodium diet . In subjects on a low-salt diet , losartan markedly increased urinary sodium excretion from 115 + /- 9 to 207 + /- 21 mumol/min ( P < .05 ) . The fractional excretion of endogenous lithium was unchanged , suggesting no effect of losartan on the early proximal tubule in our experimental conditions . Losartan also increased urine flow rate ( from 10.5 + /- 0.4 to 13.1 + /- 0.6 mL/min , P < .05 ) ; urinary potassium excretion ( from 117 + /- 6.9 to 155 + /- 11 mumol/min ) ; and the excretion of chloride , magnesium , calcium , and phosphate . In subjects on a high-salt diet , similar effects of losartan were observed , but the changes induced by the angiotensin II antagonist did not reach statistical significance . In addition , losartan demonstrated significant uricosuric properties with both sodium diets . ( ABSTRACT TRUNCATED AT 250 WORDS The aim of the present study was to evaluate the effects of a normal-sodium ( 120 mmol sodium ) diet compared with a low-sodium diet ( 80 mmol sodium ) on readmissions for CHF ( congestive heart failure ) during 180 days of follow-up in compensated patients with CHF . A total of 232 compensated CHF patients ( 88 female and 144 male ; New York Heart Association class II-IV ; 55 - 83 years of age , ejection fraction < 35 % and serum creatinine < 2 mg/dl ) were r and omized into two groups : group 1 contained 118 patients ( 45 females and 73 males ) receiving a normal-sodium diet plus oral furosemide [ 250 - 500 mg , b.i.d . ( twice a day ) ] ; and group 2 contained 114 patients ( 43 females and 71 males ) receiving a low-sodium diet plus oral furosemide ( 250 - 500 mg , b.i.d . ) . The treatment was given at 30 days after discharge and for 180 days , in association with a fluid intake of 1000 ml per day . Signs of CHF , body weight , blood pressure , heart rate , laboratory parameters , ECG , echocardiogram , levels of BNP ( brain natriuretic peptide ) and aldosterone levels , and PRA ( plasma renin activity ) were examined at baseline ( 30 days after discharge ) and after 180 days . The normal-sodium group had a significant reduction ( P<0.05 ) in readmissions . BNP values were lower in the normal-sodium group compared with the low sodium group ( 685+/-255 compared with 425+/-125 pg/ml respectively ; P<0.0001 ) . Significant ( P<0.0001 ) increases in aldosterone and PRA were observed in the low-sodium group during follow-up , whereas the normal-sodium group had a small significant reduction ( P=0.039 ) in aldosterone levels and no significant difference in PRA . After 180 days of follow-up , aldosterone levels and PRA were significantly ( P<0.0001 ) higher in the low-sodium group . The normal-sodium group had a lower incidence of rehospitalization during follow-up and a significant decrease in plasma BNP and aldosterone levels , and PRA . The results of the present study show that a normal-sodium diet improves outcome , and sodium depletion has detrimental renal and neurohormonal effects with worse clinical outcome in compensated CHF patients . Further studies are required to determine if this is due to a high dose of diuretic or the low-sodium diet Objective : To examine effects of dietary fish oil supplementation with sodium restriction on blood pressure in the elderly . Design : In a double-blind dietary intervention lasting 4 weeks , parallel comparisons of blood pressure were made in volunteers assigned to one of four treatment groups : fish oil and low sodium ; fish oil and normal sodium ; sunflower oil and low sodium ; or sunflower oil and normal sodium . Setting : Subjects lived at home and attended our nutrition research clinic at fortnightly intervals for dietary counselling and blood pressure measurement . Participants : Health volunteers aged 60 - 80 years were sought by advertisement . A total of 114 men and women were enrolled in two cohorts ; 106 , with an initial mean blood pressure of 132/77 mmHg , satisfactorily completed the study . Intervention : All subjects adopted a low-sodium diet and dietary changes were effected by double-blind administration of slow-release sodium chloride or placebo tablets , along with capsules containing either fish or sunflower oil . Main outcome measure : The primary measure was the within-subject change in blood pressure after 4 weeks of intervention in each dietary treatment group . Results : Urinary sodium excretion in subjects on low-sodium diets decreased whilst potassium excretion was unaffected . Systolic blood pressure ( SBP ) fell in the group taking sunflower oil with low sodium , but there was only a transient fall in diastolic blood pressure ( DBP ) . In those taking fish oil with normal sodium , the change in blood pressure was not significant , except after adjustment for initial blood pressure and weight changes . When fish oil was combined with low sodium , however , both SBP and DBP were substantially reduced ; the reduction in DBP was significantly greater than in the other treatment groups . Conclusion : Dietary fish oil and sodium restriction can interact to lower DBP in the elderly If high sodium intake is involved in the pathogenesis of essential hypertension , the effects of changing the sodium intake should be demonstrable in the susceptible part of the normotensive population . Therefore , we have investigated the effects of moderate salt restriction in 52 young normotensive subjects with and without a family history of hypertension ; 22 ( 42 % ) responded to moderate salt restriction ( 200 to 50 mmol/day ) over 2 weeks , with a significant fall in blood pressure shown by continuous automatic blood pressure recordings . Accordingly , these subjects were classified as salt-sensitive , and the remainder as salt-resistant . Compared to salt-resistant subjects , salt-sensitive subjects showed a 2.5-fold higher incidence of a positive family history of hypertension ( p less than 0.01 ) , and a significantly higher blood pressure and lower salivary sodium concentration during the usual high sodium diet . Although there were no differences in Na , K-ATPase activity and in Na-K cotransport of erythrocytes , the pressor response to infused norepinephrine in salt-sensitive subjects was double that of salt-resistant subjects independent of the diet and this was linked to indirect evidence for enhanced proximal tubular sodium reabsorption . On
Output:
| Sodium reduction result ed in a 1 % decrease in blood pressure in normotensives , a 3.5 % decrease in hypertensives , a significant increase in plasma renin , plasma aldosterone , plasma adrenaline and plasma noradrenaline , a 2.5 % increase in cholesterol , and a 7 % increase in triglyceride .
In general , these effects were stable in studies lasting for 2 weeks or more |
MS212443 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: & NA ; Conditioning procedures are used in many placebo studies because evidence suggests that conditioning‐related placebo responses are usually more robust than those induced by verbal suggestions alone . However , it has not been shown whether there is a causal relation between the number of conditioning trials and the resistance to extinction of placebo and nocebo responses . Here we test the effects of either one or four sessions of conditioning on the modulation of both non‐painful and painful stimuli delivered to the dorsum of the foot . Placebo and nocebo manipulations were obtained by pairing green or red light to a series of stimuli that were made lower or higher with respect to a yellow light associated with a series of control stimuli . Subjects were told that the lights would indicate a treatment that would reduce or increase non‐painful and painful stimuli to the foot . They were r and omly assigned to either Group 1 or 2 . Group 1 underwent one session of conditioning and Group 2 received four sessions of conditioning . We found that one session of conditioning ( Group 1 ) induced nocebo responses , but not placebo responses in no pain condition . After one session of conditioning , we observed both nocebo and placebo responses to painful stimulation . However , these effects extinguished over time . Conversely , four sessions of conditioning ( Group 2 ) induced robust placebo and nocebo responses to both non‐painful and painful stimuli that persisted over the entire experiment . These findings suggest that the strength of learning may be clinical ly important for producing long‐lasting placebo effects The placebo and nocebo effect is believed to be mediated by both cognitive and conditioning mechanisms , although little is known about their role in different circumstances . In this study , we first analyzed the effects of opposing verbal suggestions on experimental ischemic arm pain in healthy volunteers and on motor performance in Parkinsonian patients and found that verbally induced expectations of analgesia/hyperalgesia and motor improvement/worsening antagonized completely the effects of a conditioning procedure . We also measured the effects of opposing verbal suggestions on hormonal secretion and found that verbally induced expectations of increase/decrease of growth hormone ( GH ) and cortisol did not have any effect on the secretion of these hormones . However , if a preconditioning was performed with sumatriptan , a 5-HT1B/1D agonist that stimulates GH and inhibits cortisol secretion , a significant increase of GH and decrease of cortisol plasma concentrations were found after placebo administration , although opposite verbal suggestions were given . These findings indicate that verbally induced expectations have no effect on hormonal secretion , whereas they affect pain and motor performance . This suggests that placebo responses are mediated by conditioning when unconscious physiological functions such as hormonal secretion are involved , whereas they are mediated by expectation when conscious physiological processes such as pain and motor performance come into play , even though a conditioning procedure is performed Learning processes such as respondent or Pavlovian conditioning are believed to play an important role in the development of chronic pain , however , their influence on the inhibition of pain has so far not been assessed in humans . The purpose of this study was the demonstration of Pavlovian conditioning of stress-induced analgesia in humans and the determination of its opioid mediation . In a differential classical conditioning paradigm two different auditory stimuli served as conditioned stimuli and mental arithmetic plus white noise as unconditioned stimulus . Subsequent to four conditioning trials naloxone or placebo was applied in a double-blind fashion on two test days . Both pain threshold and pain tolerance showed conditioned stress-induced analgesia . Pain tolerance was affected by naloxone whereas pain threshold was not . The data of this study show that stress analgesia can be conditioned in humans and that it is at least partially mediated by the endogenous opioid system . Learning processes also influence pain inhibitory processes in humans and this effect might play a role in the development of chronic pain UNLABELLED Emotionally charged facial expressions ( happy , fear ) served as conditioned stimuli in a differential fear conditioning procedure . Expressions were presented in pseudo-r and om order on a computer monitor . For half of the participants , the fear expression was paired with an aversive electric stimulation ( UCS ) , whereas the happy expression was unpaired . The other participants had the opposite pairing . To assess the influence of conditioned fear on pain , expressions were shown again in the absence of the UCS and pain threshold was assessed during each expression . The latency of finger withdrawal from a radiant heat device was used to index pain threshold . Skin conductance response ( SCR ) and self-reported emotion were measured to assess fear conditioning . Consistent with preparedness theory , differential fear conditioning was only present when the fear expression was paired with the UCS . Moreover , pain threshold was only influenced by fear conditioning in persons for whom the fear expression was paired with the UCS . Specifically , finger withdrawal latencies were lower ( suggesting hyperalgesia ) during the fear expression than during the happy expression ; an effect that was not present before CS-UCS pairing . This work suggests that some stimuli are more readily associated with an aversive event and can lead to pain enhancement . PERSPECTIVE Although preliminary , these results suggest that fear-relevant environmental stimuli ( including facial expressions ) may provide important environmental cues during aversive events that influence the level of pain experienced We investigated the mechanisms underlying the activation of endogenous opioids in placebo analgesia by using the model of human experimental ischemic arm pain . Different types of placebo analgesic responses were evoked by means of cognitive expectation cues , drug conditioning , or a combination of both . Drug conditioning was performed by means of either the opioid agonist morphine hydrochloride or the nonopioid ketorolac tromethamine . Expectation cues produced placebo responses that were completely blocked by the opioid antagonist naloxone . Expectation cues together with morphine conditioning produced placebo responses that were completely antagonized by naloxone . Morphine conditioning alone ( without expectation cues ) induced a naloxone-reversible placebo effect . By contrast , ketorolac conditioning together with expectation cues elicited a placebo effect that was blocked by naloxone only partially . Ketorolac conditioning alone produced placebo responses that were naloxone-insensitive . Therefore , we evoked different types of placebo responses that were either naloxone-reversible or partially naloxone-reversible or , otherwise , naloxone-insensitive , depending on the procedure used to evoke the placebo response . These findings show that cognitive factors and conditioning are balanced in different ways in placebo analgesia , and this balance is crucial for the activation of opioid or nonopioid systems . Expectation triggers endogenous opioids , whereas conditioning activates specific subsystems . In fact , if conditioning is performed with opioids , placebo analgesia is mediated via opioid receptors , if conditioning is performed with nonopioid drugs , other nonopioid mechanisms result to be involved It is common clinical experience that anxiety about pain can exacerbate the pain sensation . Using event-related functional magnetic resonance imaging ( FMRI ) , we compared activation responses to noxious thermal stimulation while perceived pain intensity was manipulated by changes in either physical intensity or induced anxiety . One visual signal , which reliably predicted noxious stimulation of moderate intensity , came to evoke low anxiety about the impending pain . Another visual signal was followed by the same , moderate-intensity stimulation on most of the trials , but occasionally by discriminably stronger noxious stimuli , and came to evoke higher anxiety . We found that the entorhinal cortex of the hippocampal formation responded differentially to identical noxious stimuli , dependent on whether the perceived pain intensity was enhanced by pain-relevant anxiety . During this emotional pain modulation , entorhinal responses predicted activity in closely connected , affective ( perigenual cingulate ) , and intensity coding ( mid-insula ) areas . Our finding suggests that accurate preparatory information during medical and dental procedures alleviates pain by disengaging the hippocampus . It supports the proposal that during anxiety , the hippocampal formation amplifies aversive events to prime behavioral responses that are adaptive to the worst possible outcome Abstract Animal studies suggest that fear inhibits pain whereas anxiety enhances it ; however it is unclear whether these effects generalize to humans . The present study examined the effects of experimentally induced fear and anxiety on radiant heat pain thresholds . Sixty male and female human subjects were r and omly assigned to 1 of 3 emotion induction conditions : ( 1 ) fear , induced by exposure to three brief shocks ; ( 2 ) anxiety , elicited by the threat of shock ; ( 3 ) neutral , with no intervention . Pain thresholds were tested before and after emotion induction . Results suggest that findings from animal studies extend to humans : fear result ed in decreased pain reactivity , while anxiety led to increased reactivity . Pain rating data indicated that participants used consistent subjective criteria to indicate pain thresholds . Both subjective and physiological indicators ( skin conductance level , heart rate ) confirmed that the treatment conditions produced the targeted emotional states . These results support the view that emotional states modulate human pain reactivity
Output:
| The existing literature suggests that classical conditioning can amplify pain .
No conclusions can be drawn about whether or not classical conditioning can elicit pain . |
MS212444 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE This phase II study of sorafenib , an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases , assessed efficacy , toxicity , pharmacokinetics , and biomarkers in advanced hepatocellular carcinoma ( HCC ) patients . METHODS Patients with inoperable HCC , no prior systemic treatment , and Child-Pugh ( CP ) A or B , received continuous , oral sorafenib 400 mg bid in 4-week cycles . Tumor response was assessed every two cycles using modified WHO criteria . Sorafenib pharmacokinetics were measured in plasma sample s. Biomarker analysis included phosphorylated extracellular signal regulated kinase ( pERK ) in pretreatment biopsies ( immunohistochemistry ) and blood-cell RNA expression patterns in selected patients . RESULTS Of 137 patients treated ( male , 71 % ; median age , 69 years ) , 72 % had CP A , and 28 % had CP B. On the basis of independent assessment , three ( 2.2 % ) patients achieved a partial response , eight ( 5.8 % ) had a minor response , and 46 ( 33.6 % ) had stable disease for at least 16 weeks . Investigator-assessed median time to progression ( TTP ) was 4.2 months , and median overall survival was 9.2 months . Grade 3/4 drug-related toxicities included fatigue ( 9.5 % ) , diarrhea ( 8.0 % ) , and h and -foot skin reaction ( 5.1 % ) . There were no significant pharmacokinetic differences between CP A and B patients . Pretreatment tumor pERK levels correlated with TTP . A panel of 18 expressed genes was identified that distinguished " nonprogressors " from " progressors " with an estimated 100 % accuracy . CONCLUSION Although single-agent sorafenib has modest efficacy in HCC , the manageable toxicity and mechanisms of action support a role for combination regimens with other anticancer agents UNLABELLED The prognosis of untreated patients with hepatocellular carcinoma ( HCC ) is heterogeneous , and survival data were mainly obtained from control arms of r and omized studies . Clinical practice data on this topic are urgently needed , so as to help plan studies and counsel patients . We assessed the prognosis of 600 untreated patients with HCC managed by the Italian Liver Cancer Group . Prognosis was evaluated by subdividing patients according to the Barcelona Clinic Liver Cancer ( BCLC ) classification . We also assessed the main demographic , clinical , and oncological determinants of survival in the subgroup of patients with advanced HCC ( BCLC C ) . Advanced ( BCLC C : n = 138 ; 23.0 % ) and end-stage HCC ( BCLC D ; n = 210 ; 35.0 % ) represented the majority of patients . Overall median survival was 9 months , and the principal cause of death was tumor progression ( n = 279 ; 46.5 % ) . Patients ' median survival progressively and significantly decreased as BCLC stage worsened ( BCLC 0 : 38 months ; BCLC A : 25 months ; BCLC B : 10 months ; BCLC C : 7 months ; BCLC D : 6 months ; P < 0.0001 ) . Female gender ( hazard ratio [ HR ] = 0.55 ; 95 % confidence interval [ CI ] = 0.33 - 0.90 ; P = 0.018 ) , ascites ( HR = 1.81 ; 95 % CI = 1.21 - 2.71 ; P = 0.004 ) , and multinodular ( > 3 ) HCC ( HR = 1.79 ; 95 % CI = 1.21 - 2.63 ; P = 0.003 ) were independent predictors of survival in patients with advanced HCC ( BCLC C ) . CONCLUSION BCLC adequately predicts the prognosis of untreated HCC patients . In untreated patients with advanced HCC , female gender , clinical decompensation of cirrhosis , and multinodular tumor are independent prognostic predictors and should be taken into account for patient stratification in future therapeutic studies This r and omized , controlled trial assessed the effect of transarterial embolization ( TAE ) ( without associated chemotherapy ) on the survival of patients with nonsurgical hepatocellular carcinoma ( HCC ) . Eighty consecutive patients were r and omized to treatment with embolization ( Group A , n = 40 ) , or to symptomatic treatment ( Group B , n = 40 ) , there being no differences between both groups regarding the degree of liver function impairment and tumor stage . Eighty‐two percent of the patients presented a self‐limited postembolization syndrome , without treatment‐related mortality . Fifty‐five percent of the treated cases exhibited a partial response , which result ed in a lower probability of tumor progression during follow‐up ( 57 % vs. 77 % at 1 year ; P < .005 ) . However , after a median follow‐up of 24 months ( 30 deaths in each group ) , there are no differences in survival ( Group A : 49 % and 13 % ; Group B : 50 % and 27 % , at 2 and 4 years , respectively ; P = .72 ) . The absence of differences was maintained even when dividing patients according to Child‐Pugh 's grade , Okuda stage , or performance status test ( PST ) . Furthermore , there were no differences in the probability of complications or in the need of hospital admissions . In conclusion , TAE has a marked antitumoral effect associated to a slower growth of the tumor , but it does not improve the survival of patients with nonsurgical HCC OBJECTIVES : Chronic liver disease ( CLD ) is an important cause of morbidity and mortality , but the epidemiology is not well described . We conducted prospect i ve population -based surveillance to estimate newly diagnosed CLD incidence , characterize etiology distribution , and determine disease stage . METHODS : We identified cases of CLD newly diagnosed during 1999–2001 among adult county residents seen in any gastroenterology practice in New Haven County , Connecticut ; Multnomah County , Oregon ; and Northern California Kaiser Permanente Medical Care Program ( KPMCP , Oakl and , California [ total population 1.48 million ] ) . We defined CLD as abnormal liver tests of at least 6 months ' duration or pathologic , clinical , or radiologic evidence of CLD . Consenting patients were interviewed , a blood specimen obtained , and the medical record review ed . RESULTS : We identified 2,353 patients with newly diagnosed CLD ( 63.9 cases/100,000 population ) , including 1,225 hepatitis C patients ( 33.2 cases/100,000 ) . Men aged 45–54 yr had the highest hepatitis C incidence rate ( 111.3/100,000 ) . Among 1,040 enrolled patients , the median age was 48 yr ( range 19–86 yr ) . Hepatitis C , either alone ( 442 [ 42 % ] ) or in combination with alcohol-related liver disease ( ALD ) ( 228 [ 22 % ] ) , accounted for two-thirds of the cases . Other etiologies included nonalcoholic fatty liver disease ( NAFLD , 95 [ 9 % ] ) , ALD ( 82 [ 8 % ] ) , and hepatitis B ( 36 [ 3 % ] ) . Other identified etiologies each accounted for <3 % of the cases . A total of 184 patients ( 18 % ) presented with cirrhosis , including 44 % of patients with ALD . CONCLUSIONS : Extrapolating from this population -based surveillance network to the adult U.S. population , approximately 150,000 patients with CLD were diagnosed in gastroenterology practice s each year during 1999–2001 . Most patients had hepatitis C ; heavy alcohol consumption among these patients was common . Almost 20 % of patients , an estimated 30,000 per year , had cirrhosis at presentation . These results provide population -level baseline data to evaluate trends in identification of patients with CLD in gastroenterology practice BACKGROUND & AIMS The natural history of HCV-related compensated cirrhosis has been poorly investigated in Latin-American countries . Our study evaluated mortality and clinical outcomes in compensated cirrhotic patients followed for 6 years . METHODS Four hundred and two patients with compensated HCV-related cirrhosis were prospect ively recruited in a tertiary care academic center . At the time of admission , patients were stratified as compensated ( absence [ stage 1 ] or presence [ stage 2 ] of esophageal varices ) as defined by D'Amico et al. Subjects were followed to identify overall mortality or liver transplantation and clinical complication rates . RESULTS Among 402 subjects , 294 were categorized as stage 1 and 108 as stage 2 . Over a median of 176 weeks , 42 deaths occurred ( 10 % ) , of which 30 were considered liver-related ( 7 % ) and 12 non-liver-related ( 3 % ) ; eight individuals ( 2 % ) underwent liver transplantation ; 30 patients ( 7 % ) developed HCC , 67 individuals in stage 1 ( 22 % ) developed varices and any event of clinical decompensation occurred in 80 patients ( 20 % ) . The 6-year cumulative overall mortality or liver transplantation was 15 % and 45 % , for stages 1 and 2 , respectively ( p<0.001 ) . The cumulative 6-year HCC incidence was significantly higher among patients with varices ( 29 % ) than those without varices ( 9 % ) , p<0.001 . Similarly , the cumulative 6-year incidence of any clinical liver-related complication was higher in patients with stage 2 ( 66 % ) as compared to 26 % in those with stage 1 , respectively ( p<0.001 ) . CONCLUSIONS Our results indicate significant morbidity and mortality and clinical outcome rates in compensated cirrhotic patients with varices ( stage 2 ) PURPOSE Despite the absence of conclusive data , portal vein ( PV ) thrombosis is considered a contraindication to transarterial chemoembolization ( TACE ) in patients with unresectable hepatocellular carcinoma ( HCC ) . The purpose of our study was to establish the safety of TACE in such patients and identify key prognostic factors and survival . MATERIAL S AND METHODS Data were prospect ively collected from 32 consecutive patients with unresectable HCC and PV thrombosis who underwent treatment with TACE . History and physical examination , relevant laboratory values , and contrast material -enhanced magnetic resonance ( MR ) images were obtained before each TACE procedure . Repeated TACE was performed every 6 weeks unless patients developed a contraindication or MR imaging showed complete response . RESULTS Median overall survival was 9.5 months ( range , 3 - 50 months ) . Child-Pugh numerical disease stage was the prognostic factor most strongly related to survival . The 30-day mortality rate was zero and there was no evidence of TACE-related hepatic infa rct ion or acute liver failure . The 6- , 9- , 12- , and 18-month survival rates were 60 % , 47 % , 25 % , and 12.5 % , respectively . CONCLUSIONS PV thrombosis should not be considered a contraindication to TACE . Compared with historical control subjects who received traditional forms of treatment , the patients in the present study had extended survival . However , prospect i ve r and omized trials are necessary to show this conclusively and to show which subgroups benefit Transcatheter arterial chemoembolization ( TACE ) has been contraindicated for the treatment of patients with hepatocellular carcinoma ( HCC ) and main portal vein ( MPV ) obstruction because of the potential risk of hepatic insufficiency result ing from ischemia after TACE . The current controlled study was undertaken to assess the safety , efficacy , and predictive factors of favorable response to TACE in patients with HCC and MPV obstruction with good hepatic function and adequate collateral circulation around the MPV UNLABELLED Treatment with sorafenib of patients with advanced hepatocellular carcinoma is challenged by anticipated discontinuation due to tumor progression , liver decompensation , or adverse effects . While postprogression survival is clearly determined by the pattern of tumor progression , underst and ing the factors that drive prognosis in patients who discontinued sorafenib for any reason may help to improve patient management and second-line trial design . Patients consecutively admitted to three referral centers who were receiving best supportive care following permanent discontinuation of sorafenib for any reason were included . Postsorafenib survival ( PSS ) was calculated from the last day of treatment to death or last visit available . Two hundred and sixty patients were included in this prospect i ve study , aged 67 years , 60 % with hepatitis C , 51 % Child-Pugh A , 83 % performance status ( PS ) ≥1 , 41 % with macroscopic vascular invasion , and 38 % with extrahepatic tumor spread . Overall , median PSS was 4.1 ( 3.3 - 4.9 ) months , result ing from 4.6 ( 3.3 - 5.7 ) months for 123 progressors , 7.3 ( 6.0 - 10.0 ) months in 77 with adverse effects , and 1.8 ( 1.6 - 2.4 ) months in 60 decompensated patients ( P < 0.001 )
Output:
| As the acceptability curves shown , full-dose sorafenib was the optimal strategy at the accepted thresholds of WTP in these two countries .
Conclusions Dose-adjusted sorafenib may be cost-effective compared to full-dose sorafenib or TACE for advanced HCC patients .
However , when confining the comparisons between full-dose sorafenib and TACE , full-dose sorafenib was cost-effective for these patients , under the accepted thresholds of WTP |
MS212445 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Purpose : This study evaluated the risk factors for anastomotic leakage after laparoscopic surgery for rectal cancer using a stapling technique . Methods : The total prospect i ve registry of 111 patients with rectal cancer who initially underwent laparoscopic low anterior resection using a stapling technique was review ed . Univariate and multivariate analyses were carried out to identify relevant risk factors . Results : Overall anastomotic leakage rate was 5.4 % ( 6/111 ) . Univariate analysis demonstrated that body mass index ( BMI ) ( P=0.0377 ) was significantly associated with anastomotic leakage . After univariate analysis , the variables of BMI and the size of the circular stapler ( P=0.0923 ) were selected for multivariate analysis , as their P values were < 0.2 , and multivariate analysis demonstrated that BMI was independently predictive of developing anastomotic leakage ( P=0.0458 ) . Conclusions : Laparoscopic surgery for rectal cancer using a stapling technique can be performed safely without increasing the risk of anastomotic leakage , and increased BMI might be a potential risk factor for anastomotic leakage Objective : To assess with a single-blinded , multicenter , r and omized trial , the postoperative results in patients undergoing sphincter-saving rectal resection for cancer without preoperative mechanical bowel preparation ( MBP ) . Background : The collective evidence from literature strongly suggests that MBP , before elective colonic surgery , is of no benefit in terms of postoperative morbidity . Very few data and no r and omized study are available for rectal surgery and preliminary results conclude toward the safety of rectal resection without MBP . Methods : From October 2007 to January 2009 , patients scheduled for elective rectal cancer sphincter-saving resection were r and omized to receive preoperative MBP ( ie , retro grade enema and oral laxatives ) or not . Primary endpoint was the overall 30-day morbidity rate . Secondary endpoints included mortality rate , anastomotic leakage rate , major morbidity rate ( Dindo III or more ) , degree of discomfort for the patient , and hospital stay . Results : A total of 178 patients ( 103 men ) , including 89 in both groups ( no-MBP and MBP groups ) , were included in the study . The overall and infectious morbidity rates were significantly higher in no-MBP versus MBP group , 44 % versus 27 % , P = 0.018 , and 34 % versus 16 % , P = 0.005 , respectively . Regarding both anastomotic leakage and major morbidity rates , there was no significant difference between no-MBP and MBP group : 19 % versus 10 % ( P = 0.09 ) and 18 % versus 11 % ( P = 0.69 ) , respectively . Moderate or severe discomfort was reported by 40 % of prepared patients . Mortality rate ( 1.1 % vs 3.4 % ) and mean hospital stay ( 16 vs 14 days ) did not differ significantly between both groups . Conclusions : This first r and omized trial demonstrated that rectal cancer surgery without MBP was associated with higher risk of overall and infectious morbidity rates without any significant increase of anastomotic leakage rate . Thus , it suggests continuing to perform MBP before elective rectal resection for cancer . This study is registered with clinical trials.gov , number NCT00554892 PURPOSE : This study was design ed to identify the clinical features of anastomotic leakage after laparoscopic resection of rectal cancer and to evaluate the outcomes of laparoscopic management for this problem . METHODS : Prospect ively collected data were obtained from 307 patients with rectal cancer who underwent laparoscopic proctectomy and primary anastomosis . Age , sex , tumor location , tumor stage , body mass index , comorbidities , ileostomy , conversion , intraoperative blood loss , operative time , previous abdominal operation , and hospital stay were analyzed for patients with or without anastomotic leakage . Management and outcome of anastomotic leakage also were analyzed . RESULTS : Anastomotic leakage occurred in 29 patients ( 9.4 percent ) . Diverting ileostomy was initially fashioned in 65 patients ( 21.2 percent ) . Leakage was related to young age , male sex , lower tumor location , and longer operation time . Ten patients ( 34.5 percent ) were successfully managed with conservative treatment . Seventeen patients ( 58.6 percent ) were managed via a laparoscopic approach . Open surgery was performed in two patients who showed diffuse fecal soiling or had previous conversion , respectively . There was no mortality . CONCLUSIONS : When leakage occurs , laparotomy or colostomy is not needed routinely . For surgical intervention , the abdominal cavity should be explored first by laparoscopic visualization because the majority of patients can be successfully managed with laparoscopy and ileostomy PURPOSE : The aim of this study was to investigate the role of omentoplasty , by means of intact omentum , in preventing anastomotic leakages after rectal resection . METHODS : Between 1992 and 1997 a total of 112 patients ( 64 males ) with a mean age of 64.7 ( range , 39–83 ) years were r and omly assigned to undergo omentoplasty ( Group A ) or not ( Group B ) to reinforce the colorectal anastomosis after anterior resection for rectal cancer . The primary end point was anastomotic leakage ; the secondary end point included morbility and mortality related to omentoplasty . RESULTS : The two groups were comparable in terms of preoperative and intraoperative characteristics . Staple-ring disruption at plain abdominal radiographs was detected in seven instances in Group A and in ten in Group B patients ( P = not significant ) . Two leakages were evident clinical ly in Group A and seven in Group B ( P<0.05 ) . Three leaks were documented radiologically in Group A and eight in Group B ( P = not significant ) . No complications related to omentoplasty were observed in Group A. There were two repeat operations for anastomotic leakage in Group B. At follow-up , one stricture developed in Group A and three in Group B ( P = not significant ) CONCLUSIONS : Despite a similar incidence of staple-ring defects , a strikingly lower rate of clinical ly and radiologically detected leaks developed in patients su bmi tted to omentoplasty . Although not affecting the incidence of anastomotic disruption , omentoplasty seems to contain the severity of anastomotic leakage Purpose The extraperitoneal rectum is anatomically and biologically different from the intraperitoneal rectum , therefore , the surgical outcomes may be different . This study was design ed to assess operative outcomes of laparoscopic resection of extraperitoneal ( ≤7 cm from the anal verge ) vs. intraperitoneal rectal cancer . Methods Prospect i ve data were collected from 312 patients with rectal cancer who underwent laparoscopic resection . Patients were divided into two groups : extraperitoneal ( EP , n = 138 ) vs. intraperitoneal ( IP , n = 174 ) . Mean follow-up was 33 months . Results Patients with pT3/pT4 accounted for 69.6 percent of EP and 74.1 percent of IP . Circumferential margin was positive in 8.7 percent of EP and 0.6 percent of IP ( P = 0.0004 ) . Anastomotic leakage developed in 9.7 percent of EP vs. 4.6 percent of IP ( P = 0.1081 , overall 6.4 percent ) . Local recurrence rate at three years was 7.6 percent in EP and 0.7 percent in IP ( P = 0.0011 , overall 4 percent ) . By multivariate analysis , extraperitoneal location was a risk factor for local recurrence . Conclusions Laparoscopic resection of rectal cancer , regardless of EP or IP , provided acceptable operative outcomes . There was an increasing tendency for positive circumferential margin , leakage , and local recurrence in EP vs. IP . A multicenter , prospect i ve study is ongoing to identify the high-risk group for local recurrence who may really benefit from neoadjuvant therapy in the era of laparoscopy Anastomotic leakage is a major complication of rectal cancer surgery . The aim of this study was to investigate risk factors associated with symptomatic anastomotic leakage after total mesorectal excision ( TME ) Background Anastomotic leakage is the most significant complication after low anterior resection ( LAR ) for rectal carcinoma , and it is the major cause of postoperative mortality and morbidity . The objective of the present study was to investigate whether the use of a transanal tube as an alternative endoluminal diversion technique for rectal carcinoma can reduce the 30-day leakage rate after LAR . Methods From June 2003 to December 2009 , a total of 398 patients were r and omized to a transanal tube or not after LAR . Inclusion criteria for r and omization were biopsy-proven carcinoma of the rectum located ≤15 cm above the anal verge , measured with a rigid rectoscope ; age ≥ 18 years ; informed consent ; ability to underst and the study information ; estimated survival of > 6 months ; anterior resection for the lesion ; final negative air leakage test ; intact anastomotic stapler rings ; and the absence of major intraoperative adverse events . Results Patient demographics , tumor size and location , Duke ’s stage , preoperative co-morbidity , and operative details were comparable between the two groups in general analysis and subgroup analysis ( double-staple technique and h and sewn technique ) . The overall rate of symptomatic leakage was 6.78 % ( 27 of 398 patients ) . Patients r and omized to a transanal tube ( n = 200 ) had leakage in 4.0 % ( 8 of 200 patients ) and those without a tube ( n = 198 ) in 9.6 % ( 19 of 198 patients ) ( p = 0.026 ) . With regard to the double-staple technique subgroup , 3.7 % ( 7 of 188 ) patients with a tube presented with a symptomatic anastomotic leakage , compared with 9.3 % ( 17 of 182 ) of those without a tube ( p = 0.028 ) . Of the patients with anastomotic leakage in the double-staple technique subgroup , the need for urgent abdominal reoperation was 28.6 % ( two of seven patients ) in those r and omized to a transanal tube and 82.4 % ( 14 of 17 ) in those without ( p = 0.021 ) . The 30-day mortality after LAR was nil . In the double-staple technique subgroup , a quicker resumption of gastrointestinal motility manifested by a smaller ratio of patients with flatus > postoperative day ( POD ) 3 ( p = 0.019 ) and a smaller ratio of poor gastrointestinal electromyogram on POD 3 ( p < 0.001 ) was associated with use of a transanal tube . Additionally , patients with a tube appeared to have a lower rectal resting pressure by POD 3 ( 4.0 ± 2.2 vs. 5.0 ± 2.2 kPa ; p < 0.001 ) or POD 5 ( 4.3 ± 2.3 vs. 5.6 ± 2.3 kPa ; p < 0.001 ) , compared to the resting pressures patients without the device , respectively . A shorter length of hospital stay was associated with use of a transanal tube both in the double-staple technique subgroup ( p < 0.001 ) and the h and sewn technique subgroup ( p = 0.011 ) . Multivariate logistic regression analysis revealed that body mass index > 25 kg/m2 and a poor gastrointestinal electromyogram on POD 3 were found to be independent risk factors for anastomotic leakage in the low anastomosis subgroup . Conclusions The presence of a transanal tube is effective and safe in decreasing the rate of clinical ly significant anastomotic leaks and in mitigating the clinical consequences of leakage after anterior resection for rectal cancer with the technique of total mesorectal excision and double-staple anastomosis . The potential benefits of transanal tube placement are multifactorial , including drainage , reduction of endoluminal pressure , and promotion of gastrointestinal motility . Obesity and poor gastrointestinal electromyogram on POD 3 are independent risk factors for anastomotic leakage in patients with low anastomosis BACKGROUND Controversy still exists concerning the impact of patient and tumor characteristics on anastomotic dehiscence after resection for rectal cancer . METHODS Between January 1986 and July 2006 , 472 patients underwent curative rectal resection . Patient and tumor characteristics , details of treatment , and postoperative results were recorded prospect ively . Univariate and multivariate analysis were applied to identify risk factors for anastomotic leakage . RESULTS In our patients , the anastomotic leak rate was 10.4 % ( 49 of 472 patients ) , and mortality was 2.2 % ( 1 of 49 patients ) . In univariate analysis , tumor diameter and absence of a protective stoma were associated with increased anastomotic leak rate , whereas American Society of Anesthesiologists ( ASA ) score and tumor localization showed borderline significance . In multivariate analysis , tumor diameter , tumor localization , and absence of a protective stoma were significantly associated with anastomotic
Output:
| We found considerable risk and mortality for AD requiring reoperation , which largely contributed to the overall postoperative mortality |
MS212446 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background A protective effect on injury risk in youth sports through neuromuscular warm-up training routines has consistently been demonstrated . However , there is a paucity of information regarding the quantity and quality of coach-led injury prevention programmes and its impact on the physical performance of players . Objective The aim of this cluster-r and omised controlled trial was to assess whether different delivery methods of an injury prevention programme ( FIFA 11 + ) to coaches could improve player performance , and to examine the effect of player adherence on performance and injury risk . Method During the 2011 football season ( May – August ) , coaches of 31 tiers 1–3 level teams were introduced to the 11 + through either an unsupervised website or a coach-focused workshop with and without additional on-field supervisions . Playing exposure , adherence to the 11 + , and injuries were recorded for female 13-year-old to 18-year-old players . Performance testing included the Star Excursion Balance Test ( SEBT ) , single-leg balance , triple hop and jumping-over-a-bar tests . Results Complete preseason and postseason performance tests were available for 226 players ( 66.5 % ) . Compared to the unsupervised group , single-leg balance ( OR=2.8 ; 95 % CI 1.1 to 4.6 ) and the anterior direction of the SEBT improved significantly in the onfield supervised group of players ( OR=4.7 ; 95 % CI 2.2 to 7.1 ) , while 2-leg jumping performance decreased ( OR=−5.1 ; 95 % CI −9.9 to −0.2 ) . However , significant improvements in 5 of 6 reach distances in the SEBT were found , favouring players who highly adhered to the 11 + . Also , injury risk was lower for those players ( injury rate ratio , IRR=0.28 , 95 % CI 0.10 to 0.79 ) . Conclusions Different delivery methods of the FIFA 11 + to coaches influenced players ’ physical performance minimally . However , high player adherence to the 11 + result ed in significant improvements in functional balance and reduced injury risk Background Little is known about the influence of compliance with neuromuscular training ( NMT ) on the knee injury rate in football . Aim To evaluate team and player compliance with an NMT programme in adolescent female football and to study the association between compliance and acute knee injury rates . Methods Prospect i ve cohort study based on a cluster r and omised controlled trial on players aged 12–17 years with 184 intervention teams ( 2471 players ) and 157 control teams ( 2085 players ) . Exposure and acute time loss knee injuries were recorded . Team and player compliance was recorded by the coaches on a player attendance form . The intervention group was divided into tertiles of compliance . Injury rates were compared by calculating rate ratios ( RRs ) and 95 % CIs using exact Poisson tests with the low-compliance tertile as reference . Seasonal compliance trends were analysed using linear regression . Results Players in the high-compliance tertile had an 88 % reduction in the anterior cruciate ligament ( ACL ) injury rate ( RR 0.12 , 95 % CI 0.01 to 0.85 ) , whereas the rate in the control group players was not significantly different from those in the low-compliance tertile ( RR 0.77 , 95 % CI 0.27 to 2.21 ) . A significant deterioration occurred in team ( b=−3.0 % per month , 95 % CI −5.2 to −0.8 ) and player ( b=−5.0 % per month , 95 % CI −7.1 to −2.9 ) compliance over the season . Conclusions Players with high compliance with the NMT programme had significantly reduced ACL injury rate compared with players with low compliance . Significant deterioration in team and player compliance occurred over the season Objective To evaluate the effectiveness of neuromuscular training in reducing the rate of acute knee injury in adolescent female football players . Design Stratified cluster r and omised controlled trial with clubs as the unit of r and omisation . Setting 230 Swedish football clubs ( 121 in the intervention group , 109 in the control group ) were followed for one season ( 2009 , seven months ) . Participants 4564 players aged 12 - 17 years ( 2479 in the intervention group , 2085 in the control group ) completed the study . Intervention 15 minute neuromuscular warm-up programme ( targeting core stability , balance , and proper knee alignment ) to be carried out twice a week throughout the season . Main outcome measures The primary outcome was rate of anterior cruciate ligament injury ; secondary outcomes were rates of severe knee injury ( > 4 weeks ’ absence ) and any acute knee injury . Results Seven players ( 0.28 % ) in the intervention group , and 14 ( 0.67 % ) in the control group had an anterior cruciate ligament injury . By Cox regression analysis according to intention to treat , a 64 % reduction in the rate of anterior cruciate ligament injury was seen in the intervention group ( rate ratio 0.36 , 95 % confidence interval 0.15 to 0.85 ) . The absolute rate difference was −0.07 ( 95 % confidence interval −0.13 to 0.001 ) per 1000 playing hours in favour of the intervention group . No significant rate reductions were seen for secondary outcomes . Conclusions A neuromuscular warm-up programme significantly reduced the rate of anterior cruciate ligament injury in adolescent female football players . However , the absolute rate difference did not reach statistical significance , possibly owing to the small number of events . Trial registration Clinical trials NCT00894595 Background : Sport is the leading cause of injury requiring medical attention among adolescents . We studied the effectiveness of a home-based balance-training program using a wobble board in improving static and dynamic balance and reducing sports-related injuries among healthy adolescents . Methods : In this cluster r and omized controlled trial , we r and omly selected 10 of 15 high schools in Calgary to participate in the fall of 2001 . We then recruited students from physical education classes and r and omly assigned them , by school , to either the intervention ( n = 66 ) or the control ( n = 61 ) group . Students in the intervention group participated in a daily 6-week and then a weekly 6-month home-based balance-training program using a wobble board . Students at the control schools received testing only . The primary outcome measures were timed static and dynamic balance , 20-m shuttle run and vertical jump , which were measured at baseline and biweekly for 6 weeks . Self-reported injury data were collected over the 6-month follow-up period . Results : At 6 weeks , improvements in static and dynamic balance were observed in the intervention group but not in the control group ( difference in static balance 20.7 seconds , 95 % confidence interval [ CI ] 10.8 to 30.6 seconds ; difference in dynamic balance 2.3 seconds , 95 % CI 0.7 to 4.0 seconds ) . There was evidence of a protective effect of balance training in over 6 months ( relative risk of injury 0.2 , 95 % CI 0.05 to 0.88 ) . The number needed to treat to avoid 1 injury over 6 months was 8 ( 95 % CI 4 to 35 ) . Interpretation : Balance training using a wobble board is effective in improving static and dynamic balance and reducing sports-related injuries among healthy adolescents Background Injury prevention programme delivery on adherence and injury risk , specifically involving regular supervisions with coaches and players on programme execution on field , has not been examined . Aim The objective of this cluster-r and omised study was to evaluate different delivery methods of an effective injury prevention programme ( FIFA 11 + ) on adherence and injury risk among female youth football teams . Method During the 4-month 2011 football season , coaches and 13-year-old to 18-year-old players from 31 tier 1–3 level teams were introduced to the 11 + through either an unsupervised website ( ‘ control ’ ) or a coach-focused workshop with ( ‘ comprehensive ’ ) and without ( ‘ regular ’ ) additional supervisions by a physiotherapist . Team and player adherence to the 11 + , playing exposure , history and injuries were recorded . Results Teams in the comprehensive and regular intervention groups demonstrated adherence to the 11 + programme of 85.6 % and 81.3 % completion of total possible sessions , compared to 73.5 % for teams in the control group . These differences were not statistically significant , after adjustment for cluster by team , age , level and injury history . Compared to players with low adherence , players with high adherence to the 11 + had a 57 % lower injury risk ( IRR 0.43 , 95 % CI 0.19 to 1.00 ) . However , adjusting for covariates , this between-group difference was not statistically significant ( IRR=0.44 , 95 % CI 0.18 to 1.06 ) . Conclusion Following a coach workshop , coach-led delivery of the FIFA 11 + was equally successful with or without the additional field involvement of a physiotherapist . Proper education of coaches during an extensive preseason workshop was more effective in terms of team adherence than an unsupervised delivery of the 11 + programme to the team . Trial registration IS RCT N67835569 Young female players in European h and ball have a very high injury incidence , up to 50 injuries per 1000 hours of game . More than half of these injuries happen without any external cause . The aim of the study was to investigate the effect of an intervention programme design ed to reduce the number of injuries in young female players in European h and ball , with special emphasis on injuries in the lower extremities . The programme was created using elite athlete training programmes and those design ed for rehabilitation of injured athletes with functional instability of their ankles and rupture of the anterior cruciate ligament . It included the use of an ankle disk for 10 - 15 min at all practice sessions , for one 10-month season ( August 1995-May 1996 ) . Twenty-two teams participated in the study , and were r and omly assigned to the intervention or control group . Eleven teams with 111 players were r and omised to the intervention group and 11 teams with 126 players to the control group . Data were analysed using a t-test for continuous variables , chi2- analysis and Fisher 's exact test for dichotomous variables and multivariate methods to determine odds-ratios . The results indicated that using the intervention programme decreased the numbers of both traumatic and overuse injuries significantly . The differences in injuries between the groups were 80 % during games and 71 % during practice . In addition , the players in the control group had a 5.9 times higher risk of acquiring an injury than the players in the intervention group OBJECTIVE To study the effects of a school-based injury prevention program on physical activity injury incidence and severity . DESIGN Cluster r and omized controlled trial performed from January 1 , 2006 , through July 31 , 2007 . SETTING Forty Dutch primary schools . PARTICIPANTS A total of 2210 children ( aged 10 - 12 years ) . INTERVENTION Schools were r and omized to receive either the regular curriculum or an intervention program that targeted physical activity injuries . OUTCOME MEASURES Incidence and severity of physical activity injuries per 1000 hours of physical activity participation . RESULTS A total of 100 injuries in the intervention group and 104 injuries in the control group were registered . Nonresponse at baseline or follow-up was minimal ( 8.7 % ) . The Cox regression analyses adjusted for clustering showed a small nonsignificant intervention effect on total ( HR , 0.81 ; 95 % confidence interval [ CI ] , 0.41 - 1.59 ) , sports club ( 0.69 ; 0.28 - 1.68 ) , and leisure time injuries ( 0.75 ; 0.36 - 1.55 ) . However , physical activity appeared to be an effect modifier . In those who were less physically active , the intervention had a larger effect . The intervention reduced the total and leisure time injury incidence ( HR , 0.47 ; 95 % CI , 0.21 - 1.06 ; and 0.43 ; 0.16 - 1.14 ; respectively ) . Sports club injury incidence was significantly reduced ( HR , 0.23 ; 95 % CI , 0.07 - 0.75 ) . CONCLUSION We found a substantial and relevant reduction in physical activity injuries , especially in children in the low active group , because of the intervention . This school-based injury prevention program is promising , but future large-scale research is needed Injuries can be an adverse outcome of participation in sport and recreational activities . The aim of this study was to determine the public health impact of injury during sports and active recreation injury in a select population in Australia . A r and om household telephone survey was conducted quarterly over a 12-month period in a well-defined geographic region , the Latrobe Valley , Australia . Information was collected on participation in sport and active recreation and associated injuries over the previous 2 weeks for all household members aged over 4 years . Injury rates were calculated per 10,000 population and per 1000 sports participants . Data were collected on 1084 persons from 417 households . Overall , 648 people reported participating in at least one sport or active recreation and 34 ( 5.2 % , 95 % CI : 4.8 , 5.6 % ) of these sustained an injury during this activity . Overall , 51.4 % of injured cases had a significant impact : 26.5 % sought treatment , 34.4 % had their
Output:
| There is evidence for the effectiveness of neuromuscular training strategies in the reduction of injury in numerous team sports . |
MS212447 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: To evaluate the efficacy of Chinese medicine ( CM ) acupuncture for chronic neck pain ( CNP ) , a single blind , controlled , crossover , clinical trial was undertaken . Twenty-nine volunteers with CNP were r and omly recruited into two groups . Both groups received two phases of treatment with a washout period between the two phases . Group A ( 14 volunteers ) received CM acupuncture in the first phase and sham acupuncture in the second , while Group B ( 15 volunteers ) received sham in the first and real in the second . CM acupuncture was individualized and consisted of nine sessions on both local and distal points . Manual twisting of the needle was applied on all points plus strong electrical stimulation of distal points in CM acupuncture . Sham acupoints ( lateral to the real ) and sham ( weak ) electrical stimulation was used in the control group . Comparison of subjective and objective measures between the two groups was made at different periods , including baseline , after each phase of treatment , after washout , and after the 16th week follow-up . The subjective measures included pain intensity , duration per day , analgesic medication count , visual analogue scales ( VAS ) and neck disability index ( NDI ) . The objective measures consisted of neck range of motion ( ROM ) and pain threshold ( PT ) . Both the real and sham treatments significantly reduced subjective pain , without significant differences between groups for most subjective measures . Objective measures showed no significant change for either group before and after each period or by inter-groups analysis . A minimum 16-week effect of both real and sham acupuncture was found for subjective measures in the follow-up periods . Further study is recommended with an increased sample size , a longer washout period , and a longer baseline period In the majority of patients with neck pain , symptoms will resolve spontaneously or quite quickly in response to therapy . However , some patients ' symptoms persist for a long period , irrespective of therapy . In this study , 20 patients with persistent ( greater than 8 weeks ) neck pain were enrolled in a double blind , placebo-controlled trial of low energy , pulsed electromagnetic therapy (PEMT)--a treatment previously shown to be effective in soft tissue injuries . For the first 3-week period , group A ( 10 patients ) received active PEMT units while group B ( 10 patients ) received facsimile placebo units . After 3 weeks , both pain ( visual analogue scale ( P less than .023 ) and range of movement ( P less than .002 ) had improved in the group on active treatment compared to the controls . After the second 3 weeks , during which both groups used active units , there were significant improvements in observed scores for pain and range of movement in both groups . PEMT , in the form described , can be used at home easily in the treatment of patients with neck pain . It is frequently successful and without side effects We present a double-blind trial in which a pulsed infrared beam was compared with a placebo in the treatment of myofascial pain in the cervical region . The patients were su bmi tted to 12 sessions on alternate days to a total energy dose of 5 J each . At each session , the four most painful muscular trigger points and five bilateral homometameric acupuncture points were irradiated . Those in the placebo group su bmi tted to the same number of sessions following an identical procedure , the only difference being that the laser apparatus was nonoperational . Pain was monitored using the Italian version of the McGill pain question naire and the Scott-Huskisson visual analogue scale . The results show a pain attenuation in the treated group and a statistically significant difference between the two groups of patients , both at the end of therapy and at the 3-month follow-up examination OBJECTIVE This article examines the specific and nonspecific effects of Japanese acupuncture on chronic myofascial neck pain in a r and omized single-blind trial . DESIGN Forty-six patients were r and omly assigned to receive relevant acupuncture , irrelevant acupuncture , or no-acupuncture control treatment consisting of nonsteroidal anti-inflammatory medication . The two acupuncture groups underwent comparable light shallow needling . The irrelevant acupuncture group received acupuncture at specific sites not relevant for cervical pain . OUTCOME MEASURES The study measures included the McGill Pain Question naire-Short Form ( SF-MPQ ) , the Short-Form Health Survey ( SF-36 ) , the Symptom Checklist 90-Revised ( SCL-90-R ) , medication diary , and physiologic measures . The factors examined as predictors of outcome pain ratings were experience with , beliefs about , and knowledge of acupuncture before treatment ; perceived efficacy , credibility , and logic of acupuncture ; perceived competence of the acupuncturist ; and painfulness of acupuncture . RESULTS No differences were found among the three groups at baseline , except that the relevant acupuncture group reported having had more previous acupuncture treatments . No significant differences in terms of perceived credibility or perceived effectiveness of treatment were found between the two acupuncture groups . The relevant acupuncture group had significantly greater pre-/posttreatment differences in pain than the irrelevant acupuncture and control groups ( p < .05 ) . The nonspecific effects of confidence in the acupuncturist , willingness to try any treatment , mood , and physiologic effect of needling were not predictive of treatment outcome , whereas confidence in the treatment and past experiences with acupuncture did correlate significantly with a decrease in pain . CONCLUSIONS Relevant acupuncture with heat contributes to modest pain reduction in persons with myofascial neck pain . Previous experience with and confidence in treatment help to predict benefit . Measurement of nonspecific effects of alternative therapy is recommended in future clinical trials Thirteen patients with neck pain of at least two years ' duration participated in the study . Patients were r and omly assigned to either an acupuncture group or a placebo TNS ( transcutaneous nerve stimulation ) group . Initial pain scores revealed no significant difference between the groups with respect to pain severity . Patients were treated twice weekly for four weeks , at the end of which pain relief was measured using a simple descriptive scale . Even though an attempt was made to maximize the effect of placebo TNS using strong verbal suggestion , acupuncture still proved superior to placebo in the relief of cervical pain ( p less than 0.01 ) . The implication s of these findings are discussed A r and om sample including 2342 cases representative of all occupational back injuries in Quebec ( 1981 ) was followed up prospect ively over three years to assess the recurrence rate of back problems ( lumbar , thoracic , and cervical ) . Each medical and accident report was review ed to obtain the site of symptoms and occupation . Age , sex , industrial sector , and number of episodes of absence from work were abstract ed from the computerised Quebec Compensation Board files . The recurrence rate was 20.0 % at one year follow up and 36.3 % at three years . A multivariate analysis using a Poisson regression , was performed to model the risk of recurrence over time . Men had a higher chance of recurrence ( risk ratio = 1.85 , 95 % CI = 1.50 - 2.27 ) but among recurrent cases , the average total number of episodes was comparable between men and women . Age showed a protective effect on the probability of recurrence ( 10 years : RR = 0.93 , 95 % CI = 0.88 - 0.98 ) due to the lower recurrence rate in the 45 - 64 year old group ( 31.8 % ) . Cervical and lumbar symptoms had identical recurrence profiles whereas thoracic symptoms had a significantly lower recurrence rate . Drivers had the highest recurrence rate ( 42.1 % ) and nurses had the highest average number of recurrences ( 2.03 ) among recurrent cases . Both occupations had statistically significant excesses after controlling for the other variables Abstract Objectives : To compare the efficacy of acupuncture and conventional massage for the treatment of chronic neck pain . Design : Prospect i ve , r and omised , placebo controlled trial . Setting : Three outpatient departments in Germany . Participants : 177 patients aged 18–85 years with chronic neck pain . Interventions : Patients were r and omly allocated to five treatments over three weeks with acupuncture ( 56 ) , massage ( 60 ) , or “ sham ” laser acupuncture ( 61 ) . Main outcome measures : Primary outcome measure : maximum pain related to motion ( visual analogue scale ) irrespective of direction of movement one week after treatment . Secondary outcome measures : range of motion ( 3D ultrasound real time motion analyser ) , pain related to movement in six directions ( visual analogue scale ) , pressure pain threshold ( pressure algometer ) , changes of spontaneous pain , motion related pain , global complaints ( seven point scale ) , and quality of life ( SF-36 ) . Assessment s were performed before , during , and one week and three months after treatment . Patients ' beliefs in treatment were assessed . Results : One week after five treatments the acupuncture group showed a significantly greater improvement in motion related pain compared with massage ( difference 24.22 ( 95 % confidence interval 16.5 to 31.9 ) , P=0.0052 ) but not compared with sham laser ( 17.28 ( 10.0 to 24.6 ) , P=0.327 ) . Differences between acupuncture and massage or sham laser were greater in the subgroup who had had pain for longer than five years ( n=75 ) and in patients with myofascial pain syndrome ( n=129 ) . The acupuncture group had the best results in most secondary outcome measures . There were no differences in patients ' beliefs in treatment . Conclusions : Acupuncture is an effective short term treatment for patients with chronic neck pain , but there is only limited evidence for long term effects after five treatments . What is already known on this topic Acupuncture is a widespread complementary treatment Evidence from trials have given conflicting results on its use in the treatment of neck pain because of method ological shortcomings and because effects were compared either with alternative treatments or with different sham procedures imitating acupuncture , but not both What this study adds Compared with sham laser acupuncture and massage , needle acupuncture has beneficial effects on mobility and pain related to motion in patients with chronic neck pain Acupuncture was clearly more effective than massage , but differences were not always significant compared with sham laser acupuncture Acupuncture was the best treatment for patients with the myofascial syndrome and those who had had pain for longer than five Abstract Objective To determine the effectiveness of dynamic muscle training and relaxation training for chronic neck pain . Design R and omised controlled trial . Setting Five occupational healthcare centres , Tampere , Finl and . Participants 393 female office workers ( mean age 45 years ) with chronic non-specific neck pain r and omly assigned to 12 weeks of dynamic muscle training ( n = 135 ) or relaxation training ( n = 128 ) , plus one week of reinforcement training six months after baseline ; or ordinary activity ( control group ; n = 130 ) . Main outcome measure Change in intensity of neck pain at three , six , and 12 months . Results No significant difference was found in neck pain between the groups at follow up . However , the range of motion for cervical rotation and lateral flexion increased more in the training groups than in the control group . Conclusions Dynamic muscle training and relaxation training do not lead to better improvements in neck pain compared with ordinary activity The two northernmost counties in Sweden form together 1 of the 39 collaborating centers in the World Health Organization ( WHO ) MONICA ( MONItoring of trends and determinants in CArdiovascular disease ) project . At the last survey in 1999 , we added some questions about cervical spine complaints . Persons r and omly selected from the population in a geographically well-defined area completed a self-administered question naire . The sample included 8,356 subjects and 6,000 ( 72 % ) of them answered . 43 % of the population reported neck pain , more women ( 48 % ) than men ( 38 % ) . Women of working age had more neck pain than older ones , a phenomenon not seen among men . Chronic neck pain , defined as continuous pain of more than 6 months ' duration , was commoner in women ( 22 % ) than men ( 16 % ) . More than one fourth of the cases with chronic symptoms had a history of neck or head trauma and one third of these had sustained a whiplash type of injury . Thus , all types of neck trauma seem to be associated with chronic neck pain Study Design . A r and omized controlled trial with single-blind outcome assessment s. Objective . To evaluate the efficacy of a neck exercise program in patients with chronic neck pain . Summary of Background Data . The effect of exercise for patients with chronic neck pain has been investigated in a number of studies . The efficacy is , however , question able . Methods . A total of 145 patients were r and omly allocated into an exercise ( n = 67 ) and a nonexercise ( control ) group ( n = 78 ) . Patients in the control group were given infrared irradiation and neck care advice . In addition to infrared irradiation and advice , patients in the exercise group had undergone an exercise program with activation of the deep neck muscles and dynamic strengthening of the neck muscles for 6 weeks . Subjective pain and disability and isometric neck muscle strength were measured at baseline , 6 weeks , and 6 months . Analysis was by intention-to-treat . Results . At week 6 , the exercise group had a significantly better improvement in disability score ( P = 0.03 ) , subjective report of pain ( P = 0.01 ) , and in isometric neck muscle strength ( P = 0.57–0.00 ) in most of the directions than the control group . However , significant differences between the two groups were found only in the subjective report of pain and patient satisfaction at the 6-month follow-up . Conclusions . At week 6 , patients with chronic neck pain can benefit from the neck exercise program with significant improvement in disability , pain , and isometric neck muscle strength in different directions . However , the effect of exercise was less favorable at
Output:
| Conclusion It appears that the changes in pain scores in subjects with chronic neck pain not due to whiplash who are enrolled in no-treatment and placebo control groups were similarly small and not significantly different .
As well , they do not appear to increase over longer-term follow-up |
MS212448 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND There has been limited study of yoga training as a complementary exercise strategy to manage the symptom of dyspnea in patients with chronic obstructive pulmonary disease ( COPD ) . PURPOSE The primary purpose of this pilot study was to evaluate a yoga program for its safety , feasibility , and efficacy for decreasing dyspnea intensity ( DI ) and dyspnea-related distress ( DD ) in older adults with COPD . METHODS Clinical ly stable patients with COPD ( n = 29 ; age 69.9 + /- 9.5 ; forced expiratory volume in 1 second ( FEV(1 ) ) 47.7 + /- 15.6 % predicted ; female = 21 ) were r and omized to a 12-week yoga program specifically design ed for people with COPD or usual-care control ( UC ) . The twice-weekly yoga program included asanas ( yoga postures ) and visama vritti pranayama ( timed breathing ) . Safety measure outcomes included heart rate , oxygen saturation , dyspnea , and pain . Feasibility was measured by patient-reported enjoyment , difficulty , and adherence to yoga sessions . At baseline and at 12 weeks , DI and DD were measured during incremental cycle ergometry and a 6-minute walk ( 6MW ) test . Secondary efficacy outcomes included physical performance , psychologic well-being , and health-related quality of life ( HRQoL ) . RESULTS Yoga training was safe and feasible for patients with COPD . While yoga training had only small effects on DI after the 6MW test ( effect size [ ES ] , 0.20 ; p = 0.60 ) , there were greater reductions in DD in the yoga group compared to UC ( ES , 0.67 ; p = 0.08 ) . Yoga training also improved 6MW distance ( + 71.7 + /- 21.8 feet versus -27.6 + /- 36.2 feet ; ES = 0.78 , p = 0.04 ) and self-reported functional performance ( ES = 0.79 , p = 0.04 ) compared to UC . There were small positive changes in muscle strength and HRQoL. CONCLUSIONS Elderly patients with COPD participated safely in a 12-week yoga program especially design ed for patients with this chronic illness . After the program , the subjects tolerated more activity with less DD and improved their functional performance . These findings need to be confirmed in a larger , more sufficiently powered efficacy study The aim of this study was to measure the effects of a bi-weekly Raj yoga program on rheumatoid arthritis ( RA ) disease activity . Subjects were recruited from among RA patients in Dubai , United Arab Emirates by email invitations of the RA data base . Demographic data , disease activity indices , health assessment question naire ( HAQ ) , and quality of life ( QOL ) by SF-36 were documented at enrollment and after completion of 12 sessions of Raj yoga . A total of 47 patients were enrolled : 26 yoga and 21 controls . Baseline demographics were similar in both groups . Patients who underwent yoga had statistically significant improvements in DAS28 and HAQ , but not QOL . Our pilot study of 12 sessions of yoga for RA was able to demonstrate statistically significant improvements in RA disease parameters . We believe that a longer duration of treatment could result in more significant improvements AIM To evaluate the effects of a yoga-based exercise program on pain , fatigue , sleep disturbance , and biochemical markers in hemodialysis patients . MATERIAL S AND METHODS In 2004 a r and omized controlled trial was carried out in the outpatient hemodialysis unit of the Nephrology Department , Uludag University Faculty of Medicine . Clinical ly stable hemodialysis patients ( n=37 ) were included and followed in two groups : the modified yoga-based exercise group ( n=19 ) and the control group ( n=18 ) . Yoga-based exercises were done in groups for 30 min/day twice a week for 3 months . All of the patients in the yoga and control groups were given an active range of motion exercises to do for 10 min at home . The main outcome measures were pain intensity ( measured by the visual analogue scale , VAS ) , fatigue ( VAS ) , sleep disturbance ( VAS ) , and grip strength ( mmHg ) ; biochemical variables-- urea , creatinine , calcium , alkaline phosphatase , phosphorus , cholesterol , HDL-cholesterol , triglyceride , erythrocyte , hematocrit -- were evaluated . RESULTS After a 12-week intervention , significant improvements were seen in the variables : pain -37 % , fatigue -55 % , sleep disturbance -25 % , grip strength + 15 % , urea -29 % , creatinine -14 % , alkaline phosphatase -15 % , cholesterol -15 % , erythrocyte + 11 % , and hematocrit count + 13 % ; no side-effects were seen . Improvement of the variables in the yoga-based exercise program was found to be superior to that in the control group for all the variables except calcium , phosphorus , HDL-cholesterol and triglyceride levels . CONCLUSION A simplified yoga-based rehabilitation program is a complementary , safe and effective clinical treatment modality in patients with end-stage renal disease BACKGROUND Adolescents with irritable bowel syndrome ( IBS ) frequently experience interference with everyday activities . Mind-body approaches such as yoga have been recommended as interventions for patients with IBS . Despite promising results among adult sample s , there have been limited studies exploring the efficacy of yoga with pediatric patients . OBJECTIVE To conduct a preliminary r and omized study of yoga as treatment for adolescents with IBS . METHODS Twenty-five adolescents aged 11 to 18 years with IBS were r and omly assigned to either a yoga or wait list control group . Before the intervention , both groups completed question naires assessing gastrointestinal symptoms , pain , functional disability , coping , anxiety and depression . The yoga intervention consisted of a 1 h instructional session , demonstration and practice , followed by four weeks of daily home practice guided by a video . After four weeks , adolescents repeated the baseline question naires . The wait list control group then received the yoga intervention and four weeks later completed an additional set of question naires . RESULTS Adolescents in the yoga group reported lower levels of functional disability , less use of emotion-focused avoidance and lower anxiety following the intervention than adolescents in the control group . When the pre- and postintervention data for the two groups were combined , adolescents had significantly lower scores for gastrointestinal symptoms and emotion-focused avoidance following the yoga intervention . Adolescents found the yoga to be helpful and indicated they would continue to use it to manage their IBS . CONCLUSIONS Yoga holds promise as an intervention for adolescents with IBS This study examined the effects of a yoga program during pregnancy , on maternal comfort , labor pain , and birth outcomes . A r and omized trial was conducted using 74-primigravid Thai women who were equally divided into two groups ( experimental and control ) . The yoga program involved six , 1-h sessions at prescribed weeks of gestation . A variety of instruments were used to assess maternal comfort , labor pain and birth outcomes . The experimental group was found to have higher levels of maternal comfort during labor and 2h post-labor , and experienced less subject evaluated labor pain than the control group . In each group , pain increased and maternal comfort decreased as labor progressed . No differences were found , between the groups , regarding pethidine usage , labor augmentation or newborn Apgar scores at 1 and 5 min . The experimental group was found to have a shorter duration of the first stage of labor , as well as the total time of labor The present study has been conducted to evaluate selected yogic procedures on individuals with low back pain . The underst and ing of back pain as one of the commonest clinical presentations during clinical practice made the path to the present study . It has also been calculated that more than three-quarters of the world 's population experience back pain at some time in their lives . Twelve patients were selected and r and omly divided into two groups , viz . , group A yogic group and group B control group . Advice for life style and diet was given for all the patients . The effect of the therapy was assessed subjectively and objective ly . Particular scores drawn for yogic group and control group were individually analyzed before and after treatment and the values were compared using st and ard statistical protocol s. Yogic intervention revealed 79 % relief in both subjective and objective parameters ( i.e. , 7 out of 14 parameters showed statistically highly significant P < 0.01 results , while 4 showed significant results P < 0.05 ) . Comparative effect of yogic group and control group showed 79 % relief in both subjective and objective parameters . ( i.e. , total 6 out of 14 parameters showed statistically highly significant ( P < 0.01 ) results , while 5 showed significant results ( P < 0.05 ) Context Yoga combines exercise with achieving a state of mental focus through breathing . In the United States , 1 million people practice yoga for low back pain . Contribution The authors recruited patients who had a recent primary care visit for low back pain and r and omly assigned 101 to yoga or conventional exercise or a self-care book . Patients in the yoga and exercise groups reported good adherence at 26 weeks . Compared with self-care , symptoms were milder and function was better with yoga . The exercise group had intermediate outcomes . Symptoms improved between 12 and 26 weeks only with yoga . Implication s Yoga was a more effective treatment for low back pain than a self-care book . The Editors Most treatments for chronic low back pain have modest efficacy at best ( 1 ) . Exercise is one of the few proven treatments for chronic low back pain ; however , its effects are often small , and no form has been shown to be clearly better than another ( 2 - 5 ) . Yoga , which often couples physical exercise with breathing , is a popular alternative form of mindbody therapy . An estimated 14 million Americans practice d yoga in 2002 ( 6 ) , including more than 1 million who used it as a treatment for back pain ( 7 , 8) . Yoga may benefit patients with back pain simply because it involves exercise or because of its effects on mental focus . We found no published studies in western biomedical literature that evaluated yoga for chronic low back pain ; therefore , we design ed a clinical trial to evaluate its effectiveness and safety for this condition . Methods Study Design and Setting This r and omized , controlled trial compared the effects of yoga classes with conventional exercise classes and with a self-care book in patients with low back pain that persisted for at least 12 weeks . The study was conducted at Group Health Cooperative , a nonprofit , integrated health care system with approximately 500000 enrollees in Washington State and Idaho . The Group Health Cooperative institutional review board approved the study protocol , and all study participants gave oral informed consent before the eligibility screening and written consent before the baseline interview and r and omization . Patients Patients from Group Health Cooperative were recruited for 12-week sessions of classes that were conducted between June and December 2003 . We mailed letters describing the study to 6913 patients between 20 and 64 years of age who had visited a primary care provider for treatment of back pain 3 to 15 months before the study ( according to electronic visit records ) . We also advertised the study in the health plan 's consumer magazine . Patients were informed that we were comparing 3 approaches for the relief of back pain and that each was design ed to help reduce the negative effects of low back pain on people 's lives . A research assistant telephoned patients who returned statements of interest to assess their eligibility . After we received their signed informed consent forms , eligible patients were telephoned again for collection of baseline data and r and omization to treatment . We excluded individuals whose back pain was complicated ( for example , sciatica , previous back surgery , or diagnosed spinal stenosis ) , potentially attributable to specific underlying diseases or conditions ( for example , pregnancy , metastatic cancer , spondylolisthesis , fractured bones , or dislocated joints ) , or minimal ( rating of less than 3 on a bothersomeness scale of 0 to 10 ) . We also excluded individuals who were currently receiving other back pain treatments or had participated in yoga or exercise training for back pain in the past year , those with a possible disincentive to improve ( such as patients receiving workers ' compensation or those involved in litigation ) , and those with unstable medical or severe psychiatric conditions or dementia . Patients who had contraindications ( for example , symptoms consistent with severe disk disease ) or schedules that precluded class participation , those who were unwilling to practice at home , or those who could not speak or underst and English were also excluded . R and omization Protocol Participants were r and omly assigned to participate in yoga or exercise classes or to receive the self-care book . We r and omly generated treatment assignments for each class series by using a computer program with block sizes of 6 or 9 . A research er who was not involved in patient recruitment or r and omization placed the assignments in opaque , sequentially numbered envelopes , which were stored in a locked filing cabinet until needed for r and omization . Interventions The yoga and exercise classes developed specifically for this study consisted of 12 weekly 75-minute classes design ed to benefit people with chronic low back pain . In addition to attending classes held at Group Health facilities , participants were asked to practice daily at home . Participants received h and outs that described home practice s , and yoga participants received auditory compact discs to guide them through the sequence of postures with the appropriate mental focus ( examples of postures are shown in the Appendix Figure ) . Study participants retained access to all medical care provided by their insurance plan . Appendix Figure . Yoga postures Yoga We chose to use viniyoga , a therapeutically oriented style of yoga that emphasizes safety and is relatively easy to learn . Our class instructor and a senior
Output:
| CONCLUSIONS It is concluded that yoga has the potential for alleviating pain . |
MS212449 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background More than a third of the world 's children are infected with intestinal nematodes . Current control approaches emphasise treatment of school age children , and there is a lack of information on the effects of deworming preschool children . Methodology We studied the effects on the heights and weights of 3,935 children , initially 1 to 5 years of age , of five rounds of anthelmintic treatment ( 400 mg albendazole ) administered every 6 months over 2 years . The children lived in 50 areas , each defined by precise government boundaries as urban slums , in Lucknow , North India . All children were offered vitamin A every 6 months , and children in 25 r and omly assigned slum areas also received 6-monthly albendazole . Treatments were delivered by the State Integrated Child Development Scheme ( ICDS ) , and height and weight were monitored at baseline and every 6 months for 24 months ( trial registration number NCT00396500 ) . p Value calculations are based only on the 50 area-specific mean values , as r and omization was by area . Findings The ICDS infrastructure proved able to deliver the interventions . 95 % ( 3,712/3,912 ) of those alive at the end of the study had received all five interventions and had been measured during all four follow-up surveys , and 99 % ( 3,855/3,912 ) were measured at the last of these surveys . At this final follow up , the albendazole-treated arm exhibited a similar height gain but a 35 ( SE 5 ) % greater weight gain , equivalent to an extra 1 ( SE 0.15 ) kg over 2 years ( 99 % CI 0.6–1.4 kg , p = 10−11 ) . Conclusions In such urban slums in the 1990s , five 6-monthly rounds of single dose anthelmintic treatment of malnourished , poor children initially aged 1–5 years results in substantial weight gain . The ICDS system could provide a sustainable , inexpensive approach to the delivery of anthelmintics or micronutrient supplements to such population s. As , however , we do not know the control parasite burden , these results are difficult to generalize . Trial Registration Clinical Trials.gov Background Helminth infections are proposed to have immunomodulatory activities affecting health outcomes either detrimentally or beneficially . We evaluated the effects of albendazole treatment , every three months for 21 months , on STH , malarial parasitemia and allergy . Methods and Findings A household-based cluster-r and omized , double-blind , placebo-controlled trial was conducted in an area in Indonesia endemic for STH . Using computer-aided block r and omization , 481 households ( 2022 subjects ) and 473 households ( 1982 subjects ) were assigned to receive placebo and albendazole , respectively , every three months . The treatment code was concealed from trial investigators and participants . Malarial parasitemia and malaria-like symptoms were assessed in participants older than four years of age while skin prick test ( SPT ) to allergens as well as reported symptoms of allergy in children aged 5–15 years . The general impact of treatment on STH prevalence and body mass index ( BMI ) was evaluated . Primary outcomes were prevalence of malarial parasitemia and SPT to any allergen . Analysis was by intention to treat . At 9 and 21 months post-treatment 80.8 % and 80.1 % of the study subjects were retained , respectively . The intensive treatment regiment result ed in a reduction in the prevalence of STH by 48 % in albendazole and 9 % in placebo group . Albendazole treatment led to a transient increase in malarial parasitemia at 6 months post treatment ( OR 4.16(1.35–12.80 ) ) and no statistically significant increase in SPT reactivity ( OR 1.18(0.74–1.86 ) at 9 months or 1.37 ( 0.93–2.01 ) 21 months ) . No effect of anthelminthic treatment was found on BMI , reported malaria-like- and allergy symptoms . No adverse effects were reported . Conclusions The study indicates that intensive community treatment of 3 monthly albendazole administration for 21 months over two years leads to a reduction in STH . This degree of reduction appears safe without any increased risk of malaria or allergies . Trial Registration Controlled-Trials.com IS RCT Background Tribendimidine is an anthelminthic drug with a broad spectrum of activity . In 2004 the drug was approved by Chinese authorities for human use . The efficacy of tribendimidine against soil-transmitted helminths ( Ascaris lumbricoides , hookworm , and Trichuris trichiura ) has been established , and new laboratory investigations point to activity against cestodes and Strongyloides ratti . Methodology /Principal Findings In an open-label r and omized trial , the safety and efficacy of a single oral dose of albendazole or tribendimidine ( both drugs administered at 200 mg for 5- to 14-year-old children , and 400 mg for individuals ≥15 years ) against soil-transmitted helminths , Strongyloides stercoralis , and Taenia spp . were assessed in a village in Yunnan province , People 's Republic of China . The analysis was on a per- protocol basis and the trial is registered with controlled-trials.com ( number IS RCT N01779485 ) . Both albendazole and tribendimidine were highly efficacious against A. lumbricoides and , moderately , against hookworm . The efficacy against T. trichiura was low . Among 57 individuals who received tribendimidine , the prevalence of S. stercoralis was reduced from 19.3 % to 8.8 % ( observed cure rate 54.5 % , p = 0.107 ) , and that of Taenia spp . from 26.3 % to 8.8 % ( observed cure rate 66.7 % , p = 0.014 ) . Similar prevalence reductions were noted among the 66 albendazole recipients . Taking into account “ new ” infections discovered at treatment evaluation , which were most likely missed pre-treatment due to the lack of sensitivity of available diagnostic approaches , the difference between the drug-specific net Taenia spp . cure rates was highly significant in favor of tribendimidine ( p = 0.001 ) . No significant adverse events of either drug were observed . Conclusions / Significance Our results suggest that single-dose oral tribendimidine can be employed in setting s with extensive intestinal polyparasitism , and its efficacy against A. lumbricoides and hookworm was confirmed . The promising results obtained with tribendimidine against S. stercoralis and Taenia spp . warrant further investigations . In a next step , multiple-dose schedules should be evaluated Background There is considerable debate on the health impacts of soil-transmitted helminth infections . We assessed effects of deworming on physical fitness and strength of children in an area in Yunnan , People 's Republic of China , where soil-transmitted helminthiasis is highly endemic . Methodology The double-blind , r and omized , placebo-controlled trial was conducted between October 2011 and May 2012 . Children , aged 9–12 years , were treated with either triple-dose albendazole or placebo , and monitored for 6 months post-treatment . The Kato-Katz and Baermann techniques were used for the diagnosis of soil-transmitted helminth infections . Physical fitness was assessed with a 20-m shuttle run test , where the maximum aerobic capacity within 1 min of exhaustive exercise ( VO2 max estimate ) and the number of 20-m laps completed were recorded . Physical strength was determined with grip strength and st and ing broad jump tests . Body height and weight , the sum of skinfolds , and hemoglobin levels were recorded as secondary outcomes . Principal Findings Children receiving triple-dose albendazole scored slightly higher in the primary and secondary outcomes than placebo recipients , but the difference lacked statistical significance . Trichuris trichiura-infected children had 1.6 ml kg−1 min−1 ( P = 0.02 ) less increase in their VO2 max estimate and completed 4.6 ( P = 0.04 ) fewer 20-m laps than at baseline compared to non-infected peers . Similar trends were detected in the VO2 max estimate and grip strength of children infected with hookworm and Ascaris lumbricoides , respectively . In addition , the increase in the VO2 max estimate from baseline was consistently higher in children with low-intensity T. trichiura and hookworm infections than in their peers with high-intensity infections of all soil-transmitted helminths ( range : 1.9–2.1 ml kg−1 min−1 ; all P<0.05 ) . Conclusions / Significance We found no strong evidence for significant improvements in physical fitness and anthropometric indicators due to deworming over a 6-month follow-up period . However , the negative effect of T. trichiura infections on physical fitness warrants further investigation The prevalence rate of ascariasis in primary school children in northern Jakarta , Indonesia varies from 60 % to 90 % . An association between helminthic infection and educational achievement has long been recognized . This study was carried out in the northern part of Jakarta among primary school children 6 - 8 years of age . Treatment of ascariasis and health education were used as the interventions . Before the interventions , basic data on socioeconomic status , epidemiology , infection with Ascaris lumbricoides , nutritional status , and cognitive function were collected . After the interventions , only data on infection with A. lumbricoides , nutritional status , and cognitive function were collected . The children were divided into five groups . Group I was given an anthelminthic ( mebendazole ) , group II was provided with health education , group III was given an antihelminthic and provided with health education , group IV was given a placebo ( controls ) , and group V consisted of egg-negative children , who also served as controls . Data from 336 students were analyzed by analysis of covariance . Parasitologic examinations showed a mean prevalence rate of 58.4 % for A. lumbricoides infection in the pre-intervention children and a mean prevalence rate of 40.6 % in the post-intervention children . Concerning nutritional status , approximately 80 % of the children showed good scores in the pre- and post-treatment data , and only a small percentage ( 0.9 - 16.2 % ) showed mild or moderate malnutrition . No significant difference was found between the pre- and post-treatment nutritional status . The results of the cognitive test showed that the group treated with mebendazole showed significant improvement in the Colored Progressive Matrices and Coding test . Children also showed an improvement in their learning ability , concentration , and eye-h and coordination after five months of receiving this intervention BACKGROUND The effect of helminth infestation on the nutrition , growth , and physiology of the host is still poorly understood . Anthelmintic treatment of children in developing countries has had varying success in terms of growth improvements . OBJECTIVE The objective of this study was to assess the effect of regular deworming on child growth , physiology , and biochemical status . DESIGN The study was a 12-mo longitudinal intervention in 123 Bangladeshi children aged 2 - 5 y. Treatment ( mebendazole ) or placebo tablets were administered every 2 mo for 8 mo and again at 12 mo . Weight , height , midupper arm circumference , intestinal permeability , plasma albumin , alpha(1)-antichymotrypsin , and total protein concentration were assessed every 2 mo . RESULTS Treatment with mebendazole reduced the prevalence of Ascaris lumbricoides from 78 % to 8 % , of Trichuris trichiura from 65 % to 9 % , and of hookworm from 4 % to 0 % . There was no significant difference in the growth of treated children compared with those given placebo tablets . No changes in intestinal permeability or plasma albumin were observed after deworming . Significant decreases in total protein ( P<0.001 ) and alpha(1)-antichymotrypsin ( P<0.001 ) were observed in the treatment group , indicating possible reductions in inflammation and immunoglobulin concentration after deworming . A significant increase in the prevalence of Giardia intestinalis ( from 4 % to 49 % ) in the treatment group was associated with a short-term reduction in weight ( P = 0.02 ) and higher intestinal permeability ( P < 0.001 ) in infected subjects . No long-term effects of G. intestinalis on growth were observed . CONCLUSION Low-intensity helminth infections , predominantly of A. lumbricoides and T. trichiura , do not contribute significantly to the poor growth and biochemical status of rural Bangladeshi children We studied growth in infected children given one dose ( 600 mg ) or two doses of albendazole per school year . Children were examined and allocated at r and om within sex by descending hookworm egg count to one of three groups : placebo ( n = 93 ) , one dose ( 1x , n = 96 ) or two doses ( 2x , n = 95 ) . Each child was treated and then re-examined and treated 3.6 and 8.2 mo later ( Exams 2 and 3 ) . The 1x and 2x groups gained significantly more by Exam 3 than the placebo group in weight ( 1.1 and 0.9 kg more
Output:
| Authors ' conclusions Treating children known to have worm infection may have some nutritional benefits for the individual .
However , in mass treatment of all children in endemic areas , there is now substantial evidence that this does not improve average nutritional status , haemoglobin , cognition , school performance , or survival |
MS212450 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Pancreaticoduodenectomy remains the only potentially curative treatment for adenocarcinoma of the pancreas . The aim of this study was to analyze prognostic factors impacting survival after R0 pancreaticoduodenectomy for adenocarcinoma in the head of the pancreas . Between 1995 and 2002 , a potentially curative ( R0 ) pancreaticoduodenectomy with pancreatogastrostomy for ductal adenocarcinoma in the head of the pancreas was performed in 81 patients ( 42 women and 39 men ) with a mean age of 64 years ( range 35–84 ) . Patients were identified from a prospect i ve data base and records were review ed retrospectively . Postoperative mortality was 1 % , and 40 % of patients had complications . Median survival was 18 months , and the 5-year survival was 24 % . Fifteen patients were alive at 5 years . Factors associated with poor survival in multivariate analysis were ( 1 ) two or more positive lymph nodes , ( 2 ) tumor diameter greater than 30 mm , and ( 3 ) age greater than 70 years . In patients with no or with one positive lymph node , the 5-year survival was 44 % . On the other h and , in patients with two or more positive lymph nodes , both the 3- and 5-year survival was 5 % . The main risk factor associated with poor survival after an R0 pancreaticoduodenectomy for adenocarcinoma in the head of pancreas was lymph node status : The presence of two or more positive lymph nodes was associated with decreased survival Objective : To prospect ively evaluate the survival benefit of dissection of the nerve plexus and lymphadenectomy in patients with pancreatic head cancer . Background : Despite r and omized controlled trials on the extent of surgery in pancreatic cancer , attempts have been made to perform more extended resections . Methods : A total of 244 patients were enrolled ; of these , 200 were r and omized to undergo st and ard resection or extended resection , with the latter including the dissection of additional lymph nodes and the right half of the nerve plexus around the superior mesenteric artery and celiac axis . We evaluated 167 patients from 7 centers who fulfilled all of the required criteria . Result : Operation time was longer and estimated blood loss was higher in the extended resection group than in the st and ard resection group , but the R0 resection rate was comparable . The mean number of lymph nodes retrieved per patient was higher in the extended resection group than in the st and ard resection group ( 33.7 vs 17.3 ; P < 0.001 ) . The morbidity rate was slightly higher in the extended resection group than in the st and ard resection group . Two patients in the extended resection group died in hospital . Median survival after R0 resection was similar in the extended resection and st and ard resection groups ( 18.0 vs 19.0 months ; P = 0.239 ) regardless of lymph node metastasis . Adjuvant chemoradiation had a positive impact on overall survival . Conclusions : This study suggests that extended lymphadenectomy with dissection of the nerve plexus does not provide a significant survival benefit compared with st and ard resection in pancreatic head cancer . St and ard resection can be performed safely and efficiently , without negatively affecting oncologic efficacy or long-term survival , when compared with extended pancreaticoduodenal resection . ( NCT00679913 ) Background The value of pancreatoduodenectomy ( PD ) with extended lymphadenectomy for pancreatic cancer has been evaluated by many retrospective studies and 3 r and omized controlled trials ( RCT ) . However , the protocol s used and the results found in the 3 RCTs were diverse . Therefore , a multicenter RCT was proposed in 1998 to evaluate the primary end point of long-term survival and the secondary end points of morbidity , mortality and quality of life of patients undergoing st and ard versus extended lymphadenectomy in radical PD for pancreatic cancer . Methods From March 2000 to May 2003 , 112 patients with potentially curable pancreatic head cancer were enrolled and intraoperatively r and omized to a st and ard or extended lymphadenectomy group . No resected patients received any adjuvant treatments . Results A hundred and one eligible patients were analyzed . Demographic and histopathological characteristics of the two groups were similar . The mean operating time , intraoperative blood loss and number of retrieved lymph nodes were greater in the extended group , but the other operative results were comparable . Conclusions Although this multicenter RCT was conducted in a strict setting , extended lymphadenectomy in radical PD did not benefit long-term survival in patients with resectable pancreatic head cancer and led to levels of morbidity , mortality and quality of life comparable to those found after st and ard lymphadenectomy Objective To evaluate , in a prospect i ve , r and omized single-institution trial , the end points of operative morbidity , operative mortality , and survival in patients undergoing st and ard versus radical ( extended ) pancreaticoduodenectomy . Summary Background Data Numerous retrospective reports and a few prospect i ve r and omized trials have suggested that the performance of an extended lymphadenectomy in association with a pancreaticoduodenal resection may improve survival for patients with pancreatic and other periampullary adenocarcinomas . Methods Between April 1996 and June 2001 , 299 patients with periampullary adenocarcinoma were enrolled in a prospect i ve , r and omized single-institution trial . After intraoperative verification ( by frozen section ) of margin-negative resected periampullary adenocarcinoma , patients were r and omized to either a st and ard pancreaticoduodenectomy ( removing only the peripancreatic lymph nodes en bloc with the specimen ) or a radical ( extended ) pancreaticoduodenectomy ( st and ard resection plus distal gastrectomy and retroperitoneal lymphadenectomy ) . All pathology specimens were review ed , fully categorized , and staged . The postoperative morbidity , mortality , and survival data were analyzed . Results Of the 299 patients r and omized , 5 ( 1.7 % ) were subsequently excluded because their final pathology failed to reveal periampullary adenocarcinoma , leaving 294 patients for analysis ( 146 st and ard vs. 148 radical ) . The two groups were statistically similar with regard to age ( median 67 years ) and gender ( 54 % male ) . All the patients in the radical group underwent distal gastric resection , while 86 % of the patients in the st and ard group underwent pylorus preservation ( P < .0001 ) . The mean operative time in the radical group was 6.4 hours , compared to 5.9 hours in the st and ard group ( P = .002 ) . There were no significant differences between the two groups with respect to intraoperative blood loss , transfusion requirements ( median zero units ) , location of primary tumor ( 57 % pancreatic , 22 % ampullary , 17 % distal bile duct , 3 % duodenal ) , mean tumor size ( 2.6 cm ) , positive lymph node status ( 74 % ) , or positive margin status on final permanent section ( 10 % ) . The mean total number of lymph nodes resected was significantly higher in the radical group . Of the 148 patients in the radical group , only 15 % ( n = 22 ) had metastatic adenocarcinoma in the resected retroperitoneal lymph nodes , and none had retroperitoneal nodes as the only site of lymph node involvement . One patient in the radical group with negative pancreaticoduodenectomy specimen lymph nodes had a micrometastasis to one perigastric lymph node . There were six perioperative deaths ( 4 % ) in the st and ard group versus three perioperative deaths ( 2 % ) in the radical group ( P = NS ) . The overall complication rates were 29 % for the st and ard group versus 43 % for the radical group ( P = .01 ) , with patients in the radical group having significantly higher rates of early delayed gastric emptying and pancreatic fistula and a significantly longer mean postoperative stay . With a mean patient follow-up of 24 months , there were no significant differences in 1- , 3- , or 5-year and median survival when comparing the st and ard and radical groups . Conclusions Radical ( extended ) pancreaticoduodenectomy can be performed with similar mortality but some increased morbidity compared to st and ard pancreaticoduodenectomy . The data to date fail to indicate that a survival benefit is derived from the addition of a distal gastrectomy and retroperitoneal lymphadenectomy to a pylorus-preserving pancreaticoduodenectomy BACKGROUND The role of adjuvant treatment in pancreatic cancer remains uncertain . The European Study Group for Pancreatic Cancer ( ESPAC ) assessed the roles of chemoradiotherapy and chemotherapy in a r and omised study . METHODS After resection , patients were r and omly assigned to adjuvant chemoradiotherapy ( 20 Gy in ten daily fractions over 2 weeks with 500 mg/m(2 ) fluorouracil intravenously on days 1 - 3 , repeated after 2 weeks ) or chemotherapy ( intravenous fluorouracil 425 mg/m(2 ) and folinic acid 20 mg/m(2 ) daily for 5 days , monthly for 6 months ) . Clinicians could r and omise patients into a two-by-two factorial design ( observation , chemoradiotherapy alone , chemotherapy alone , or both ) or into one of the main treatment comparisons ( chemoradiotherapy versus no chemoradiotherapy or chemotherapy versus no chemotherapy ) . The primary endpoint was death , and all analyses were by intention to treat . Findings 541 eligible patients with pancreatic ductal adenocarcinoma were r and omised : 285 in the two-by-two factorial design ( 70 chemoradiotherapy , 74 chemotherapy , 72 both , 69 observation ) ; a further 68 patients were r and omly assigned chemoradiotherapy or no chemoradiotherapy and 188 chemotherapy or no chemotherapy . Median follow-up of the 227 ( 42 % ) patients still alive was 10 months ( range 0 - 62 ) . Overall results showed no benefit for adjuvant chemoradiotherapy ( median survival 15.5 months in 175 patients with chemoradiotherapy vs 16.1 months in 178 patients without ; hazard ratio 1.18 [ 95 % CI 0.90 - 1.55 ] , p=0.24 ) . There was evidence of a survival benefit for adjuvant chemotherapy ( median survival 19.7 months in 238 patients with chemotherapy vs 14.0 months in 235 patients without ; hazard ratio 0.66 [ 0.52 - 0.83 ] , p=0.0005 ) . Interpretation This study showed no survival benefit for adjuvant chemoradiotherapy but revealed a potential benefit for adjuvant chemotherapy , justifying further r and omised controlled trials of adjuvant chemotherapy in pancreatic cancer Due to uncertainties regarding clinical ly meaningful gains from adjuvant chemotherapy after colorectal cancer surgery , several Nordic Groups in the early 1990s initiated r and omised trials to prove or reject such gains . This report gives the joint analyses after a minimum 5-year follow-up . Between October 1991 and December 1997 , 2 224 patients under 76 years of age with colorectal cancer stages II and III were r and omised to surgery alone ( n = 1 121 ) or adjuvant chemotherapy ( n = 1 103 ) which varied between trials ( 5FU/levamisole for 12 months , n = 444 ; 5FU/leucovorin for 4 - 5 months according to either a modified Mayo Clinic schedule ( n = 262 ) or the Nordic schedule ( n = 397 ) . Some centres also r and omised patients treated with 5FU/leucovorin to+/-levamisole ) . A total of 812 patients had colon cancer stage II , 708 colon cancer stage III , 323 rectal cancer stage II and 368 rectal cancer stage III . All analyses were according to intention-to-treat . No statistically significant difference in overall survival , stratified for country or region , could be found in any group of patients according to stage or site . In colon cancer stage III , an absolute difference of 7 % ( p = 0.15 ) , favouring chemotherapy , was seen . The present analyses corroborate a small but clinical ly meaningful survival gain from adjuvant chemotherapy in colon cancer stage III , but not in the other presentations BACKGROUND To compare operative morbidity , mortality , quality of life , and survival after pancreatoduodenectomy ( PD ) versus pancreatoduodenectomy with extended lymphadenectomy ( PD/ELND ) in patients with resectable pancreatic cancer . METHODS From May 1997 to July 2003 there were 132 patients with biopsy examination-proven or suspected adenocarcinoma of the pancreatic head who agreed to participate in a single-institution , prospect i ve , r and omized trial . If resectable at operation , patients then were r and omized to st and ard PD ( 40 patients ) or PD/ELND ( 39
Output:
| ConclusionS PD is associated with reduced morbidity , but equivalent long-term benefits compared to patients undergoing EPD |
MS212451 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE To compare the ability of pediatric residents to differentiate an asymmetric from a symmetric red reflex in patients with anisometropia and microstrabismus using the Brückner reflex and the Medical Technology Innovations ( MTI ) photoscreener . METHODS A prospect i ve , masked , case-control study was performed . Twelve pediatric residents evaluated 10 study patients and 6 control subjects in a masked manner in 2 separate sessions , using the Brückner reflex or the MTI photoscreener , evaluating for asymmetric ( abnormal ) or symmetric ( normal ) red reflexes between the 2 eyes . Each study patient had asymmetric red reflexes and the amblyogenic risk factor of anisometropia or microstrabismus . Each control subject had symmetric red reflexes . RESULTS The pediatric residents had a mean correct score of 82 % ( 69%-100 % ) using the MTI photoscreener versus a mean correct score of 65 % ( 44%-81 % ) using the Brückner reflex ( McNemar test : alpha < 0.01 ) . The sensitivity of the MTI photoscreener evaluation was 89 % in comparison to 61 % for the Brückner reflex . The specificities for the MTI photoscreener versus the Brückner reflex were similar at 69 % and 71 % , respectively . CONCLUSIONS Pediatric residents were better at detecting asymmetric red reflexes in patients with anisometropia and microstrabismus when evaluating MTI photoscreener photographs than when evaluating the red reflexes by the Brückner reflex . The MTI photoscreener may be a more sensitive method than the Brückner reflex to screen for the common amblyogenic risk factors of anisometropia and microstrabismus by easier detection of red reflex asymmetry PURPOSE To evaluate the diagnostic accuracy of the plusoptiX S04 digital photoscreener in a school screening program . METHODS Between 2006 and 2007 , 1343 information pamphlets/consent forms were sent to all junior kindergarten students in a local school district . Assistants from a local public health unit photographed 307 children . Of these , 271 children received an independent ophthalmic examination by a physician . Photographic results were compared with the those of the ophthalmic examination . Amblyopia risk factors were defined as anisometropia > 1 D ( sphere or cylinder ) , astigmatism > 1.25 D , myopia > 3 D , hyperopia > 3.5 D , any manifest strabismus , and any media opacity . RESULTS Photographic and examination results agreed in 94 % of cases . Sensitivity in detecting amblyopia risk factors was 83 % ; specificity was 95 % . The positive and negative predictive values were 73 % and 97 % , respectively . The untestable/unusable rate was 1 % . CONCLUSIONS These results compare favorably with a previously reported ( but no longer available ) digital photoscreening camera and are superior to results obtained with other off-axis photoscreening devices that require human interpretation . On the basis of these results , in a real-world screening program , the camera would falsely refer 4 % of those screened and would fail to correctly refer 2 % . The accuracy of the plusoptiX S04 camera in detecting amblyopia risk factors appears sufficiently high to consider its further deployment in a widespread school screening program Aim To evaluate the efficacy of the three-dimensional ( 3D ) Strabismus Photo Analyzer for estimating binocular alignment using photographs . Methods Thirty-two subjects with exotropia , 30 subjects with esotropia and 38 orthotropic subjects were included . Two independent ophthalmologists examined the angle of deviation using the Krimsky test and prism and alternate cover test ( PCT ) . Full-face photographs were obtained using an 8.2-megapixel digital single-lens reflex camera , and the images were analysed using the 3D Strabismus Photo Analyzer . The images were adjusted for age-dependent ophthalmic biometry and angle κ . The main outcome measures were inter-observer variability , test‐retest reliability and correlation between the angles of deviation measured by different methods . Results The 95 % limit of agreement of inter-observer variability was ±3.5 ° ( 6.1 prism dioptres ( PD ) ) , ±3.1 ° ( 5.4 PD ) and ±1.5 ° ( 2.6 PD ) for the Krimsky test , PCT and the 3D Strabismus Photo Analyzer , respectively . The test‐retest reliability was ±2.8 ° ( 4.9 PD ) for the 3D Strabismus Photo Analyzer versus the Krimsky test . The results of the Krimsky test and 3D Strabismus Photo Analyzer showed a strong positive correlation . Conclusions The 3D Strabismus Photo Analyzer is a simple and reliable tool for measuring ocular deviation . It has excellent agreement with the Krimsky test and substantially improved reproducibility The primate visual cortex , including that of man , receives separate input from each eye and these interact in binocular cortical neurones . This organization is known to be vulnerable to disruption in early life1 . To underst and the development of human visual cortex , and to detect and assess disorders of binocular function at the earliest possible age , a robust method is needed for detecting binocular interactions in the infant 's visual system . We have done this by recording cortical visual evoked responses ( VERs ) to the onset and offset of binocular correlation in a large-screen dynamic r and om dot display . We report here that , in general , the human infant has a functional binocular visual cortex by 3 months of age , with some individuals showing cortical binocularity at an earlier age A Cochrane review of literature from 1966 to 2004 on screening for correctable visual acuity defects in school-aged children and adolescents found “ no robust trials available that allow the benefits of school vision screening to be measured . The disadvantage of attending school with a visual acuity deficit also needs to be quantified . The impact of a screening program will depend on the geographical , and the socio-economic setting in which it is conducted ” [ 2 ] . However , major refractive errors can occur in 5 % to 7 % of preschoolers [3][4 ] ; individual r and omized , longitudinal studies report that early screening has been associated with a decrease in the prevalence of amblyopia and improved acuity by 60 % [ 5 ] . Screening before three years of age is associated with a 70 % lower prevalence of amblyopia after treatment [4][6 ] . The single and most effective test for amblyopia is the determination of visual acuity by noninvasive testing . A Cochrane review on screening specifically for amblyopia ( 1966 to 2005 ) concluded that “ the lack of data from r and omized controlled trials makes it difficult to analyze the impact of screening programs on the prevalence of amblyopia . The absence of such evidence can not be taken to mean that vision screening is not beneficial ; simply that this intervention has not yet been tested in robust studies ” [ 7 ] . Adverse effects on educational and social development , as well as limitations to career choice are obvious consequences of poor visual acuity . Uncorrected amblyopia is a significant risk factor for total blindness , in the case of injury or disease , in the better functioning eye . The American Academy of Ophthalmology and the American Academy of Pediatrics [ 6 ] recommend visual assessment from birth and at all routine health supervisory visits . The child ’s anatomy and function should be checked at regular infant and well-child visits , and visual acuity should be assessed at the preschool stage as well as when there is a complaint . Infants with a known risk ( retinopathy of prematurity , Down ’s syndrome , etc ) or significant family history ( congenital glaucoma , strabismus ) should be referred for further evaluation [ 6 ] PURPOSE To compare 11 preschool vision screening tests administered by licensed eye care professionals ( LEPs ; optometrists and pediatric ophthalmologists ) . DESIGN Multicenter , cross-sectional study . PARTICIPANTS A sample ( N = 2588 ) of 3- to 5-year-old children enrolled in Head Start was selected to over-represent children with vision problems . METHODS Certified LEPs administered 11 commonly used or commercially available screening tests . Results from a st and ardized comprehensive eye examination were used to classify children with respect to 4 targeted conditions : amblyopia , strabismus , significant refractive error , and unexplained reduced visual acuity ( VA ) . MAIN OUTCOME MEASURES Sensitivity for detecting children with > or = 1 targeted conditions at selected levels of specificity was the primary outcome measure . Sensitivity also was calculated for detecting conditions grouped into 3 levels of importance . RESULTS At 90 % specificity , sensitivities of noncycloplegic retinoscopy ( NCR ) ( 64 % ) , the Retinomax Autorefractor ( 63 % ) , SureSight Vision Screener ( 63 % ) , and Lea Symbols test ( 61 % ) were similar . Sensitivities of the Power Refractor II ( 54 % ) and HOTV VA test ( 54 % ) were similar to each other . Sensitivities of the R and om Dot E stereoacuity ( 42 % ) and Stereo Smile II ( 44 % ) tests were similar to each other and lower ( P<0.0001 ) than the sensitivities of NCR , the 2 autorefractors , and the Lea Symbols test . The cover-uncover test had very low sensitivity ( 16 % ) but very high specificity ( 98 % ) . Sensitivity for conditions considered the most important to detect was 80 % to 90 % for the 2 autorefractors and NCR . Central interpretations for the MTI and iScreen photoscreeners each yielded 94 % specificity and 37 % sensitivity . At 94 % specificity , the sensitivities were significantly better for NCR , the 2 autorefractors , and the Lea Symbols VA test than for the 2 photoscreeners for detecting > or = 1 targeted conditions and for detecting the most important conditions . CONCLUSIONS Screening tests administered by LEPs vary widely in performance . With 90 % specificity , the best tests detected only two thirds of children having > or = 1 targeted conditions , but nearly 90 % of children with the most important conditions . The 2 tests that use static photorefractive technology were less accurate than 3 tests that assess refractive error in other ways . These results have important implication s for screening preschool-aged children Stereoscopic depth perception was tested in human infants by a new method based on attracting the infant 's attention through movement of a stereoscopic contour formed from a dynamic r and om-element stereogram . The results reveal that stereopsis emerges at 3 1/2 to 6 months of age , an outcome consistent with evidence for rapid postnatal development of the visual system PURPOSE To assess the accuracy of the Lang II stereotest in screening for strabismus , amblyopia , and anisometropia in 6-year-old children . DESIGN Cross-sectional population -based study . METHODS The Sydney Myopia Study examined 1765 6-year-old children ( 78.9 % of eligible ) who were identified by r and om cluster sampling of 34 schools in Sydney , Australia . Sensitivity and specificity of the Lang II stereotest was determined by best stereoacuity . Cycloplegic autorefraction , assessment of visual acuity , and ocular motility were conducted . RESULTS Test sensitivity ranged from 21.4 % for anisometropia ( > or = 1.0 diopter ) to 31.3 % for amblyopia . The detection rate for new cases of amblyopia ranged from 20 % to 40 % ; the detection rate for new cases of strabismus was 30 % . Specificity was > 98 % in all three conditions . Children with false-negative results included newly diagnosed cases of strabismus ( 14 of 25 children ) or amblyopia ( 5 of 12 children ) . CONCLUSION The Lang II stereotest , when used alone , has very limited value as a screening test of binocular dysfunction Purpose To determine the efficacy of distance stereotesting as a screening device . Methods Distance stereoacuity using the global R and om Dot and contour Circle test of the Mentor BVAT II-SG computerized testing system was measured for 216 patients , ages 6 to 18 years , before the clinical examination . Patients were classified into pass/fail groups in the areas of refractive error change ( REC ) , ocular deviation ( DEV ) , visual acuity ( VA ) , and all three together ( EXAM ) . Legitimate cutoff scores were obtained when patients were classified as ‘ pass ’ as follows : REC if the change was 0.50 D or less in sphere or cylinder relative to the habitual correction or to emmetropia if no habitual correction ; DEV if there was no heterophoria or strabismus at distance ( criteria of heterophoria of < 6 prism diopters and heterophorias of any magnitude were also tested ) ; VA if the acuity at distance was better than or equal to 20/25 in the poorer eye and better than or equal to 20/20 in the better eye ; EXAM if they were pass in REC , DEV , and VA . Optimal pass/fail cutoff values for the stereopsis measurements were determined by finding the maximum & khgr;2 value from contingency tables constructed using pass/fail levels for the screening test at each of the observed levels . Results The pass rates for REC , DEV , VA , and EXAM were 45 % , 72 % , 42 % , and 24 % , respectively . Patients passed the B
Output:
| There is very limited data in the literature to ascertain the accuracy of tests for detecting strabismus in the community as performed by non-expert screeners . |
MS212452 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Background and Purpose Hemiplegic shoulder pain is not uncommon after stroke . Its origin is still unknown , and although many different methods of treatment are applied , none have yet been proved to be effective . We sought to study the efficacy of 3 injections of intra-articular triamcinolone acetonide on pain and arm function in stroke patients with hemiplegic shoulder pain . Methods In a multicenter , r and omized , placebo-controlled clinical trial , patients with hemiplegic shoulder pain received either 3 intra-articular injections of 40 mg triamcinolone acetonide or 1 mL physiological saline solution ( placebo ) . Primary outcomes were pain measured according to 3 visual analogue scales ( score range , 0 to 10 ) , and arm function was measured by means of the Action Research Arm test and the Fugl-Meyer assessment scale ; secondary outcomes were passive external rotation of the shoulder and general functioning measured according to Barthel Index and the Rehabilitation Activities Profile . Results In the triamcinolone group ( n=18 ) , the median decrease in pain , 3 weeks after the last injection , was 2.3 ( interquartile range , 0.3 to 4.3 ) versus 0.2 ( interquartile range , −0.5 to 2.2 ) in the placebo group . This result was not statistically significant . The change in the other outcome measures did not differ significantly between the 2 treatment groups . Twenty-five patients reported side effects . Conclusions In the 37 participants included in this study , triamcinolone injections seemed to decrease hemiplegic shoulder pain and to accelerate recovery , but this effect was not statistically significant . Therefore , on the basis of the results of this study , these injections can not be recommended for the treatment of patients with hemiplegic shoulder pain BACKGROUND AND PURPOSE Subluxation is a significant problem in poststroke hemiplegia , result ing in pain and loss of function . Current treatments are not proved and not considered effective . It has been demonstrated that cyclical electrical stimulation of the shoulder muscles can reduce existing subluxation . The purpose of this study was to determine whether electrical stimulation could prevent subluxation in both the short and long terms . METHODS A prospect i ve , r and omized controlled study was used to determine the efficacy of electrical stimulation in preventing shoulder subluxation in patients after cerebrovascular accidents . Forty patients were selected and r and omly assigned to a control or treatment group . They had their first assessment within 48 hours of their stroke , and those in the treatment group were immediately put on a regimen of electrical stimulation for 4 weeks . All patients were assessed at 4 weeks after stroke and then again at 12 weeks after stroke . Assessment s were made of shoulder subluxation , pain , and motor control . RESULTS The treatment group had significantly less subluxation and pain after the treatment period , but at the end of the follow-up period there were no significant differences between the 2 groups . CONCLUSIONS Electrical stimulation can prevent shoulder subluxation , but this effect was not maintained after the withdrawal of treatment BACKGROUND AND PURPOSE Visual analogue scales ( VAS ) have been used for the subjective measurement of mood , pain , and health status after stroke . In this study we investigated how stroke-related impairments could alter the ability of subjects to answer accurately . METHODS Consent was obtained from 96 subjects with a clinical stroke ( mean age , 72.5 years ; 50 men ) and 48 control subjects without cerebrovascular disease ( mean age , 71.5 years ; 29 men ) . Patients with reduced conscious level or severe dysphasia were excluded . Subjects were asked to rate the tightness that they could feel on the ( unaffected ) upper arm after 3 low-pressure inflations with a st and ard sphygmomanometer cuff , which followed a predetermined sequence ( 20 mm Hg , 40 mm Hg , 0 mm Hg ) . Immediately after each change , they rated the perceived tightness on 5 scales presented in a r and om order : 4-point rating scale ( none , mild , moderate , severe ) , 0 to 10 numerical rating scale , mechanical VAS , horizontal VAS , and vertical VAS . St and ard tests recorded deficits in language , cognition , and visuospatial awareness . RESULTS Inability to complete scales with the correct pattern was associated with any stroke ( P<0.001 ) . There was a significant association between success using scales and milder clinical stroke subtype ( P<0.01 ) . Within the stroke group , logistic regression analysis identified significant associations ( P<0.05 ) between impairments ( cognitive and visuospatial ) and inability to complete individual scales correctly . CONCLUSIONS Many patients after a stroke are unable to successfully complete self-report measurement scales , including VAS The purpose of this study was to evaluate the effectiveness of a functional electrical stimulation ( FES ) treatment program design ed to prevent glenohumeral joint stretching and subsequent subluxation and shoulder pain in stroke patients . Twenty-six recent hemiplegic stroke patients with shoulder muscle flaccidity were r and omly assigned to either a control group ( n = 13 ; 5 female , and 8 male ) or experimental group ( n = 13 ; 6 female , and 7 male ) . Both groups received conventional physical therapy . The experimental group received additional FES therapy where two flaccid/paralyzed shoulder muscles ( supraspinatus and posterior deltoid ) were induced to contract repetitively up to 6 hours a day for 6 weeks . Duration of both the FES session and muscle contraction/relaxation ratio were progressively increased as performance improved . The experimental group showed significant improvements in arm function , electromyographic activity of the posterior deltoid , range of motion , and reduction in subluxation ( as indicated by x-ray ) compared with the control group . We concluded that the FES program was effective in reducing the severity of shoulder subluxation and pain , and possibly facilitating recovery of arm function Ninety seven patients with stroke who had participated in a r and omised trial of conventional physical therapy nu an enhanced therapy for arm function were followed up at one year . Despite the emphasis of the enhanced therapy approach on continued use of the arm in everyday life , the advantage seen for some patients with enhanced therapy at six months after stroke had diminished to a non-significant trend by one year . This was due to some late improvement in the conventional therapy group whereas the enhanced therapy group remained static or fell back slightly . It is recommended that trials should be conducted comparing very intensive therapy for the arm with controls without treatment . This would provide a model of the effects of therapy on intrinsic neural recovery that would be relevant to all areas of neurological rehabilitation Previous research on stroke rehabilitation has not established whether increase in physical therapy lead to better intrinsic recovery from hemiplegia . A detailed study was carried out of recovery of arm function after acute stroke , and compares orthodox physiotherapy with an enhanced therapy regime which increased the amount of treatment as well as using behavioural methods to encourage motor learning . In a single-blind r and omised trial , 132 consecutive stroke patients were assigned to orthodox or enhanced therapy groups . At six months after stroke the enhanced therapy group showed a small but statistically significant advantage in recovery of strength , range and speed of movement . This effect seemed concentrated amongst those who had a milder initial impairment . More work is needed to discover the reasons for this improved recovery , and whether further development of this therapeutic approach might offer clinical ly significant gains for some patients Effects of intra-articular triamcinolone acetonide on pain and passive range of motion ( ROM ) in the painful hemiplegic shoulder were studied . A Multiple baseline ( or AB ) design across seven subjects was used . The length of the baseline condition ( or A phase ) was either 2 or 3 wk , and r and omized across subjects . Subsequently , a treatment condition ( or B phase ) of 4 wk was applied during which three intra-articular injections of triamcinolone acetonide were administered at day 1 , 8 , and 22 . Pain and ROM were the primary outcome parameters and were measured three times each week by means of a visual analogue scale ( VAS ) and a fluid-filled goniometer , respectively . In addition , a number of secondary outcome parameters were assessed , i.e. , spastic muscle activity ( Ashworth scale ) , motor function ( Fugl-Meyer index ) , upper limb function ( action research arm test ) and signs and symptoms of a shoulder h and syndrome ( clinical scoring list ) . Statistical analysis of the combined time series showed significant effects on pain ( P = 0.025 ) . Analysis of the individual time series revealed that five out of seven patients had significant reduction of pain . ROM improved significantly in four out of seven patients . However , improvement of ROM did not reach significance at the group level ( P = 0.13 ) . None of the secondary parameters showed significant changes . The correlation coefficient between upper limb function ( ARA ) at intake and size of treatment effect approached a level of significance ( P = 0.09 ) . The results indicate that intra-articular triamcinolone may be of benefit in reducing hemiplegic shoulder pain Shoulder pain and stiffness is a serious problem in patients following stroke . The purpose of this study was to investigate the effect of a shoulder positioning protocol on shoulder joint pain and range in the affected upper limb . Twenty-eight subjects were r and omly assigned to the experimental or control groups and participated in a multidisciplinary rehabilitation program . In addition , the experimental group received prolonged positioning of the shoulder daily for six weeks . Resting pain , pain on dressing , pain-free active abduction and passive external rotation range were measured on entry to the study and after six weeks . Twenty-three subjects completed the study . The differences between the groups were not statistically significant ( p < 0.05 ) , however , because of low statistical power the results are inconclusive The aim of this paper is to evaluate the effectiveness of high-intensity versus low-intensity transcutaneous electrical nerve stimulation ( TENS ) and versus placebo for treatment of hemiplegic shoulder pain . Three groups of 20 patients each ( A , B , C ) were studied . In group A high-intensity TENS was delivered at 3 times the sensory threshold with frequency of 100 Hz ; in group B low-intensity TENS was delivered at the sensory threshold with frequency of 100 Hz . Group C received placebo stimulation . The treatment protocol consisted of 12 sessions ( 4 weeks ) . Before treatment , at the end of it and one month after , passive range of motion ( PROM ) for flexion , extension , abduction and external rotation were evaluated . Statistically significant improvements of PROMs were recorded for group A , but not for groups B or The object of this study is to determine if the functional motor capacity of the paretic extremity can be improved by stimulation with low intensity low frequency ( 1.7 Hz ) transcutaneous electric nerve stimulation ( Low-TENS ) , started 6 - 12 months after a stroke . Forty-four patients who had a paretic arm as a consequence of their first stroke were included and r and omly assigned to either a treatment group ( n = 26 ) or a control group ( n = 18 ) . Patients in both groups received physiotherapy at a day-care center , usually twice a week . The treatment group received , in addition , Low-TENS for 60 min , five days a week for three months . Results showed that motor function increased significantly in the treatment group , compared to controls . The Low-TENS did not decrease either pain or spasticity . It is concluded that stimulation by means of Low-TENS could be a valuable complement to the usual training of arm and h and function in the rehabilitation of stroke patients One of the causes for shoulder pain associated with hemiplegia is thought to be vigorous range of motion to the involved upper extremity . The objective of this study was to analyze the occurrence of pain in patients treated with one of the three exercise programs commonly used in the rehabilitation of hemiplegia : 1 ) range of motion by the therapist , 2 ) skate board and 3 ) overhead pulley . Of the 48 hemiplegic patients evaluated , 28 were assigned to one of the three exercise groups . Comparing the number of patients who developed pain in each group , there was a significant difference , with 8 % of the patients in the range of motion by the therapist group , 12 % of the patients in the skate board group and 62 % of the patients in the overhead pulley group developing pain ( x2=8.44 ) ( P=0.014 ) . The three groups did not differ in the side of involvement ( P=0.57 ) , extent of hemiplegia ( P=0.25 ) or presence of subluxation ( P=0.84 ) . Use of overhead pulley has the highest risk of developing shoulder pain and should be avoided during rehabilitation of stroke patients Objective : To determine whether strapping the shoulder in hemiplegic stroke patients : ( 1 ) prevents the development , or reduces the severity , of shoulder pain , ( 2 ) preserves range of movement in the shoulder , and ( 3 ) improves the functional outcomes for the arm and patient overall . Design : A prospect i ve , r and omized , single-blind controlled trial of shoulder strapping versus no strapping . Setting : Care of the elderly wards in a teaching hospital , Christchurch , New Zeal and . Subjects : All patients admitted with an acute hemiplegic stroke , who had persisting weakness of shoulder abduction . Intervention : The treatment group had their affected shoulder strapped for six weeks from r and omization in addition to st and ard physiotherapy . Main outcome measures : All subjects were assessed at entry ( week 0 ) , at end of the treatment phase ( week 6 ) and two months later ( week 14 ) . A visual analogue scale ( VAS ) was used to assess shoulder pain severity whereas shoulder range of movement to the point of pain ( SROMP ) assessed passive range of movement and pain . Functional Independence Measure ( FIM ) , Motor Assessment Scale ( MAS ) and Rankin Disability Index measured functional outcomes . Results : Ninety-eight subjects participated ( 49 strapped , 49 controls ) . Intention to treat analysis showed no significant difference in pain , range of movement or functional outcomes after the intervention phase or at the final assessment . However there were trends for less pain at six weeks ( VAS , p = 0.11 ) and better final upper
Output:
| With this limited evidence , no single intervention has been identified that offers a dramatic effect in terms of treating pain in the hemiplegic shoulder .
There is potential for some benefits for the patient 's functional and comfort status , thereby improving their quality of life and maximising their social participation .
Preventive interventions demonstrated that a shoulder positioning policy had no statistically significant effect on pain .
Some studies did suggest evidence of improvement , albeit limited .
However , some of the exercise techniques aggravated shoulder pain .
Treatment interventions demonstrated that electromyogram biofeedback can not be evaluated as a st and -alone therapy as it is used in conjunction with relaxation therapy .
Intra-articular Triamcinolone Acetonide injections in a small RCT have not been proven to be beneficial , and are associated with a high incidence of side-effects .
Different exercise techniques may aggravate shoulder pain more than others ( e.g. Bobath technique compared to cryotherapy ) .
The systematic review on the effectiveness of functional electrical stimulation was used for prevention and treatment and concluded that there is currently no evidence for effect |
MS212453 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Background : Local application of allergen extracts in specific immunotherapy is accompanied by increased compliance and significantly reduced side effects . However , efficacy of local immunotherapy in children has yet not been sufficiently demonstrated . This study was performed to determine clinical efficacy of high dose sublingual swallow immunotherapy ( SLIT ) by a double‐blind placebo‐controlled study in children with grass pollen allergy using high dose allergen extracts UNLABELLED SAFETY and efficacy of sublingual ( sublingual-swallow ) immunotherapy ( IT ) with house dust mite extract were evaluated in 30 children ( 6 - 15 2/3 years of age ) over the first 12 months of an ongoing study . The cumulative dose was 570 micrograms Der p I ( five times that administered with subcutaneous therapy ) . SAFETY One patient on active treatment dropped out after 8 weeks because of a subjective feeling of severe weakness , question ably induced by the therapy . Five patients on active therapy and one patient on placebo reported minor local side effects . EFFICACY Pulmonary symptoms were reduced after 12 months in actively treated asthmatics , but this was not consistent with the lack of improvement in bronchial reactivity , skin sensitivity and specific IgG and IgG4 against D.pt . in this group . In patients with rhinitis nasal sensitivity was reduced in the placebo group without concomitant improvement in the nasal symptom score . Specific IgE ( D.pt . and D.f . ) increased significantly more in the active treatment group after 3 and 12 months . We conclude that sublingual IT over 12 months with the fivefold Der p 1 dose of subcutaneous IT was well tolerated , but there was no consistent clinical or immunological benefit compared to placebo A double-blind , placebo-controlled study of immunotherapy was conducted in 31 patients with allergic rhinitis due to Parietaria pollen to evaluate the efficacy and safety of high doses of allergen via the sublingual route . The patients were assessed before and after a 10-month period of treatment by clinical ( symptom-medication scores and specific nasal reactivity ) and immunological ( total IgE , specific IgE , IgG and IgG4 antibodies ) parameters . High doses of Parietaria extract corresponding to a cumulative dose of 105 BU for each patient were administered with negligible side effects . The actively treated patients had significantly lower medication scores than those on placebo ( p < 0.05 ) when the maximum pollen count was recorded , and at the end of the trial they showed a significant decrease in nasal reactivity ( p < 0.02 ) and a significant increase in serum specific IgG4 ( p = 0.02 ) . No differences were detected in any of these parameters in the placebo group . Possible explanations for the mechanisms of sublingual immunotherapy are proposed Thirty-four patients suffering from rhinoconjunctivitis with or without asthma due to grass pollen , were su bmi tted to sublingual immunotherapy according to a double blind placebo controlled experimental plan ; eighteen patients received the active therapy , sixteen the placebo . A rush preseasonal treatment schedule was followed in order to reach the maintenance dose in 15 days with two administrations per day ; the top dose reached was then administered three times a week until the end of the pollen season . The symptoms and drugs related to rhinoconjunctivitis and asthma were recorded by means of diary cards and grass pollen counts were performed during the season . The actively treated group showed a reduction of symptoms of rhinoconjunctivitis and asthma and a lower intake of drugs for the same symptoms ; all these differences result ed to be statistically significant . No patient showed local or systemic side effects of any relevance . According to these results of our study , sublingual rush immunotherapy is clinical ly effective and because of the ease of h and ling , the shortness of the treatment , the absence of relevant side effects and the high compliance of the patient can be considered as an alternative to classic injective immunotherapy in grass pollen allergic patients 58 patients under 12 years of age , positive to mites ( Dermatophagoides pteronyssinus and D. farinae ) according to prick , in vitro specific IgE and challenge tests , suffering from asthma and rhinitis , have been r and omly assigned on a double blind basis to receive per os either a biologically st and ardized extract of mites ( active therapy TA = 30 patients ) or a saline buffered solution ( placebo TP = 28 patients ) . The serologic results are interesting . The specific IgE level differences of significance are , in comparison with the placebo group . In particular , we did observe the increase of the specific IgE level in the placebo group during the autumn , whereas after 12 months and after 24 months of active treatment there was a clear ( p < 0.01 ) decline in serum specific IgE antibody . In the active group , there was a significant increase in IgG antibodies level after 12 and 24 months and a significant increase in IgG4 level after 24 months . In the placebo group , the level of IgG antibodies was unchanged . In the actively treated patients , a significant increase of CD8 + values and a significant reduction of the ratio CD4+/CD8 + was observed BACKGROUND Sublingual swallow immunotherapy has been increasingly recognized as a safe and efficacious alternative to parenteral specific immunotherapy . OBJECTIVE To determine the safety and efficacy of sublingual swallow immunotherapy ragweed allergen extract for rhinoconjunctivitis treatment starting just before and continuing through the ragweed pollen season . METHODS This r and omized , double-blind , placebo-controlled study was performed in children and adults with a documented history of allergic rhinoconjunctivitis during ragweed season at 9 Canadian allergy centers . Active treatment was st and ardized extract of ragweed allergen administered as sublingual swallow drops at increasing doses starting shortly before the pollen season and maintenance doses continued daily during the season . Primary efficacy variables were symptom and medication scores , and secondary variables included global evaluation of efficacy and immunologic measurements . RESULTS Eighty-three patients were included in the safety analysis ; 76 patients were included in the intent-to-treat analysis . Nine placebo recipients and 1 treatment recipient withdrew for lack of efficacy ( P = .004 ) . Nine patients in the treatment group withdrew because of adverse events , none serious ( P = .003 ) . Investigator evaluation of efficacy showed that significantly more patients improved and fewer deteriorated in the treatment group vs the placebo group ( P = .047 ) . Ragweed IgE and IgG4 levels increased significantly in treatment recipients vs placebo users ( P < .001 ) . Sneezing and nasal pruritus approached significant improvement in the treatment group vs the placebo group ( P = .09 and .06 , respectively ) . Quebec City experienced low pollen counts . Excluding Quebec City , significant improvement was seen for these 2 symptoms ( P = .04 ) . CONCLUSION Sublingual swallow immunotherapy seems to be safe and efficacious for ragweed rhinoconjunctivitis even when started immediately before the ragweed pollen season Background : Especially in childhood , sublingual immunotherapy ( SLIT ) could offer advantages over subcutaneous therapy . However , limited data on its efficacy is available Sublingual immunotherapy has been suggested for the treatment of respiratory allergies . Many controversial studies have been reported on the efficacy of sublingual immunotherapy . The aim of this prospect i ve study was to evaluate whether sublingual immunotherapy was effective according to clinical and laboratory results in pediatric allergies . Thirty-nine allergic , grass pollen sensitive children were admitted into the study . Sublingual immunotherapy was given over a 12-month period to 21 children ( mean age 10.5 + /- 3.3 years ) , 10 of whom had seasonal allergic rhinitis and 11 seasonal allergic asthma . During the same period , 18 children ( mean age 11.1 + /- 2.5 years ) , 10 with seasonal allergic rhinitis and eight with seasonal allergic asthma , received placebo . Symptom scores and drug requirements were recorded and urine sample s were collected to detect urinary levels of leukotrienes ( Uc-LTB4 and Uc-LTE4 ) . In patients who received sublingual immunotherapy , the symptom scores of seasonal allergic rhinitis significantly decreased , but no statistically significant changes were observed in terms of symptoms of seasonal allergic asthma . Uc-LTE4 and Uc-LTB4 levels of seasonal allergic rhinitis , with a geometric mean and 95 % confidence interval ( CI ) , were significantly decreased from 216 ( 103 - 464 ) and 61 ( 22 - 198 ) pmol/mmol creatinine to 78 ( 29 - 159 ) and 35 ( 12 - 118 ) pmol/mmol creatinine , respectively ( p < 0.05 and p < 0.05 ) . On the other h and , Uc-LTE4 and Uc-LTB4 levels for seasonal allergic asthma were 180 ( 92 - 355 ) and 78 ( 44 - 258 ) pmol/mmol creatinine and decreased to 156 ( 72 - 402 ) and 69 ( 32 - 254 ) pmol/mmol creatinine , respectively . These changes were not statistically significant ( p > 0.05 ) . According to our clinical results and urinary levels of leukotrienes , which are mediators showing the severity of allergic inflammation , it can be suggested that sublingual immunotherapy may be useful in the treatment of seasonal allergic rhinitis but not of seasonal allergic asthma BACKGROUND sublingual immunotherapy has been recognised as safe and effective but it is still poorly documented in tree pollen allergy . Allergy to alder , birch and hazel is important in Northern European countries but its clinical relevance is increasing in Southern Europe . METHODS thirty patients , selected and observed for one pollen season , were r and omised to receive placebo ( 15 patients ) or active treatment ( 15 patients ) . Twenty-seven patients completed the first year and 24 of them were treated with active therapy during the second year of the study in comparison to a parallel group of ten patients treated only with drugs . Symptom and drug scores during each pollen season , birch-specific IgE , changes in skin test reactivity , changes in specific Nasal Provocation Test and the daily average pollen count for the relevant trees were considered for the assessment of the efficacy of the treatment . RESULTS both active and placebo group showed a statistically significant improvement in scores in comparison to the previous year , under a lower allergenic pressure . The improvement was higher in the active group ( 76.04 % reduction of drugs ) but not significantly different from that registered in the placebo group ( 37.05 % reduction ) . In the open phase of the study , treated patients showed significantly better scores in comparison to the control group . No significant changes in skin reactivity , specific IgE and Nasal Provocation Test were registered . SLIT tolerance was very good . CONCLUSIONS our data show a better but not statistically significant clinical outcome for patients actively treated with SLIT , but the placebo effect and the year-by-year variability of the environmental allergenic load in our small-size pilot study do not allow for a conclusive statement about the efficacy of this form of therapy Sublingual‐swallow immunotherapy ( SLIT ) using high doses of st and ardized allergen extracts has been found to be effective in reducing allergic symptoms and medication needs . A double‐blind , placebo‐controlled study was carried out in a large number of patients to determine whether medication needs can be reduced by SLIT . Some 136 patients with grass‐pollen rhinitis with or without mild asthma were studied . Patients received either placebo or SLIT with a st and ardized grass‐pollen extract administered daily with increasing doses up to 300 IR ( index of reactivity ) from January to the end of July 1994 . During the grass‐pollen season , patients were instructed to use medications as required and to visit their doctors in case of asthma . Symptom‐medications scores were assessed during the pollen season , and serum‐specific IgG4 was measured before and at the end of SLIT . In the SLIT group , drug consumption dropped significantly throughout the pollen season ( P<0.02 ) . Moreover , at the peak of the pollen season , betamethasone consumption was significantly reduced in the SLIT group ( P<0.02 ) . Only one patient in the SLIT group had an asthma attack compared to eight patients in the placebo group ( P<0.02 ) . IgG4 levels increased significantly in the SLIT group ( P<0.001 ) but without correlation with symptoms . Side‐effects were comparable in both groups . This study indicates that SLIT in grass‐pollen rhinitis is well tolerated , improves overall clinical symptoms , and reduces drug consumption and the need for oral corticosteroids In a double-blind , placebo-controlled , pilot clinical trial we evaluated the clinical efficacy and safety of immunotherapy ( IT ) with an extract of the pollen of the tree Olea europaea administered sublingually . The parameters tested were symptom score , dose-response bioassay of skin prick test and specific IgE and IgG , and the absolute value at a single serum dilution of each IgG subclass . Fifteen patients allergic to this pollen with symptomatology of rhinitis and /or rhinoconjunctivitis were r and omly allocated to the placebo group ( 6 patients ) or to the extract group ( 9 patients ) . Immunotherapy was administered in a short preseasonal period of time , practically no side effects being recorded . The group of patients treated with extract presented a slightly lower incidence ( 0.05 < p < 0.1 ) of nasal symptoms of sneez
Output:
| Subgroup analyses failed to identify a disproportionate benefit of treatment according to the allergen administered .
Increasing duration of treatment does not clearly increase efficacy .
REVIEW ER 'S CONCLUSIONS SLIT is a safe treatment which significantly reduces symptoms and medication requirements in allergic rhinitis . |
MS212454 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Recent research has suggested that enhanced retraining for stroke patients using haptics ( robotic forces ) and graphics ( visual display ) to generate a practice environment that can artificially enhance error rather than reducing it , can stimulate new learning and foster accelerated recovery . We present an evaluation of early results of this novel post-stroke robotic-aided therapy trial that incorporates these ideas in a large VR system and simultaneously employs the patient , the therapist , and the technology to accomplish effective therapy Background . The 10-meter walk test and 6-minute walk test are increasingly used to evaluate the recovery of walking in patients with incomplete spinal cord injury . So far , there is no evidence whether the application of different walking distances provides complementary information about ambulatory capacity in patients with incomplete spinal cord injury . Studies about testing preferred and maximum speeds in subjects with incomplete spinal cord injury are lacking . Objective . To determine whether the combined testing of short and long distances as well as preferred and maximum speeds provides additional information about walking capacity in subjects with incomplete spinal cord injury . Methods . Depending on the objective , the subjects with incomplete spinal cord injury and age-matched control subjects had to perform the 10-meter walk test or 6-minute walk test at preferred and /or maximum walking speed . Results . During recovery , the preferred walking speed increased but did not differ when assessed during short or long distances in 51 subjects with incomplete spinal cord injury at 1 , 3 , and 6 months after injury ( mean and SD , 6-minute walk test : 0.37 ± 0.52 , 0.87 ± 0.56 , and 1.14 ± 0.52 ms —1 ; 10-meter walk test : 0.40 ± 0.53 , 0.88 ± 0.51 , and 1.12 ± 0.51 ms—1 , respectively ) . In 18 subjects with incomplete spinal cord injury , both preferred and maximum walking speeds assessed with the 10-meter walk test predicted the walking speeds of the 6-minute walk test well . Subjects with incomplete spinal cord injury prefer to walk closer to their maximum walking speed ( 74 % ± 10 % ) compared to control subjects ( 59 % ± 8 % ) . Conclusions . The velocity used for the 6-minute walking distance and the 10-meter walking speed provides comparable information in patients with incomplete spinal cord injury who can perform both tests . However , tests of the preferred and maximum walking speed add information about walking capacity . Due to the easier applicability of the 10-meter walk test in the clinical setting , the authors suggest performing this test at the preferred and maximum speeds for the assessment of walking capacity by 1 month after incomplete spinal cord injury Fifty individuals with incomplete tetraplegia due to trauma underwent serial prospect i ve examinations to quantify motor and sensory recovery . None of 5 patients who were motor complete with the presence of sacral ( S4-S5 ) sharp/dull touch sensation unilaterally recovered any lower extremity motor function . However , in 8 motor complete subjects having bilateral sacral sharp/dull sensation present , the mean lower extremity motor score increased to 12.1 + /- 7.8 at 1 year . In 3 of the 8 cases , functional ( > or = 3/5 ) recovery was seen in some muscles at 1 year . Though mean upper and lower extremity ASIA Motor Scores increased significantly ( p < .001 ) between 1 month and 1 year for the entire sample , the annualized rate of motor recovery rapidly declined in the first 6 months and then subsequently approached plateau . Eighty-seven percent ( 20 of 23 ) of patients having a lower extremity motor score > or = 10 at 1 month were community ambulators using crutches and orthoses at 1 year follow-up We used a lower limb robotic exoskeleton controlled by the wearer 's muscle activity to study human locomotor adaptation to disrupted muscular coordination . Ten healthy subjects walked while wearing a pneumatically powered ankle exoskeleton on one limb that effectively increased plantar flexor strength of the soleus muscle . Soleus electromyography amplitude controlled plantar flexion assistance from the exoskeleton in real time . We hypothesized that subjects ' gait kinematics would be initially distorted by the added exoskeleton power , but that subjects would reduce soleus muscle recruitment with practice to return to gait kinematics more similar to normal . We also examined the ability of subjects to recall their adapted motor pattern for exoskeleton walking by testing subjects on two separate sessions , 3 days apart . The mechanical power added by the exoskeleton greatly perturbed ankle joint movements at first , causing subjects to walk with significantly increased plantar flexion during stance . With practice , subjects reduced soleus recruitment by approximately 35 % and learned to use the exoskeleton to perform almost exclusively positive work about the ankle . Subjects demonstrated the ability to retain the adapted locomotor pattern between testing sessions as evidence d by similar muscle activity , kinematic and kinetic patterns between the end of the first test day and the beginning of the second . These results demonstrate that robotic exoskeletons controlled by muscle activity could be useful tools for testing neural mechanisms of human locomotor adaptation An active ankle-foot orthoses ( AAFO ) is presented where the impedance of the orthotic joint is modulated throughout the walking cycle to treat drop-foot gait . During controlled plantar flexion , a biomimetic torsional spring control is applied where orthotic joint stiffness is actively adjusted to minimize forefoot collisions with the ground . Throughout late stance , joint impedance is minimized so as not to impede powered plantar flexion movements , and during the swing phase , a torsional spring-damper control lifts the foot to provide toe clearance . To assess the clinical effects of variable-impedance control , kinetic and kinematic gait data were collected on two drop-foot participants wearing the AAFO . For each participant , zero , constant , and variable impedance control strategies were evaluated and the results were compared to the mechanics of three age , weight , and height matched normals . We find that actively adjusting joint impedance reduces the occurrence of slap foot allows greater powered plantar flexion and provides for less kinematic difference during swing when compared to normals . These results indicate that a variable-impedance orthosis may have certain clinical benefits for the treatment of drop-foot gait compared to conventional ankle-foot orthoses having zero or constant stiffness joint behaviors The Spinal Cord Independence Measure ( SCIM ) is a new disability scale developed specifically for patients with spinal cord lesions in order to make the functional assessment s of patients with paraplegia or tetraplegia more sensitive to changes . The SCIM includes the following areas of function : self-care ( subscore 0 – 20 ) , respiration and sphincter management ( 0 – 40 ) and mobility ( 0 – 40 ) . Each area is scored according to its proportional weight in these patients ' general activity . The final score ranges from 0 to 100 . This study was performed to evaluate the reliability of the SCIM and its sensitivity to functional changes in spinal cord lesion patients compared with the Functional Independence Measure ( FIM ) . Thirty patients were included . Scores were recorded one week after admission and thereafter every month during hospitalization . Each area of function was assessed by a pair of staff members from the relevant discipline . The comparison of scores between each pair of raters revealed a remarkable consistency ( r=0.91 – 0.99 ; P<0.0001 ; slope≈1 ; constant≈0 ) . The total SCIM score ( mean=51 , SD=21 ) was lower than the total FIM score ( mean=87 , SD=23 ) owing to the difference in scale range structure and the relatively high cognitive scores of our patients ; however , a relationship was noted between the scores of both scales ( r=0.85 , P<0.01 ) . The SCIM was more sensitive than the FIM to changes in function of spinal cord lesion patients : the SCIM detected all the functional changes detected by the FIM total scoring , but the FIM missed 26 % of the changes detected by the SCIM total scoring . The mean difference between consecutive scores was higher for the SCIM ( P<0.01 ) . We conclude that the SCIM is a reliable disability scale and is more sensitive to changes in function in spinal cord lesion patients than the FIM . The SCIM when administered by a multidisciplinary team , may be a useful instrument for assessing changes in everyday performance in patients with spinal cord lesion
Output:
| RESULTS The actuated ankle-foot orthoses currently available are characterized by several combinations of an actuator and a control mechanism .
Both the actuator and the control strategy substantially influence human-machine interaction and therefore the potential of the device to assist in modifying locomotor function and potentially modify the underlying motor control mechanisms .
CONCLUSION Due to small sample sizes , limited studies in patients with spinal cord injury , and limitations in study design , it is difficult to draw firm conclusions on the effect of different types of actuated ankle-foot orthoses .
Based on the limited data available , pneumatic artificial muscles in combination with proportional myoelectric control are suggested to have the potential to meet most of the preconditions to restore the attributes of normal gait and therefore facilitate neuroplasticity |
MS212455 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract Objective : To evaluate the effectiveness of combinations of three methods to promote physical activity . Design : R and omised controlled trial . Baseline assessment with post-intervention follow up at 12 weeks and 1 year . Setting : One urban general practice , 1995 - 7 . Participants : 523 adults aged 40 to 64 years , r and omised to four intervention groups and a control group . Interventions : Brief ( one interview ) or intensive ( six interviews over 12 weeks ) motivational interviewing based on the stages of change model of behaviour change , with or without financial incentive ( 30 vouchers entitling free access to leisure facilities ) . Main outcome measures : Physical activity score ; sessions of moderate and vigorous activity in the preceding four weeks . Results : Response rate was 81 % at 12 weeks and 85 % at one year . More participants in the intervention group reported increased physical activity scores at 12 weeks than controls ( 38 % v 16 % , difference 22 % , 95 % confidence interval for difference 13 % to 32 % ) , with a 55 % increase observed in those offered six interviews plus vouchers . Vigorous activity increased in 29 % of intervention participants and 11 % of controls ( difference 18 % , 10 % to 26 % ) , but differences between the intervention groups were not significant . Short term increases in activity were not sustained , regardless of intensity of intervention . Conclusions : The most effective intervention for promoting adoption of exercise was the most intensive . Even this did not promote long term adherence to exercise . Brief interventions promoting physical activity that are used by many schemes in the United Kingdom are of question able effectiveness . Key messages Schemes promoting physical activity are currently popular in general practice in Britain , but few have been rigorously evaluated and their effectiveness is unknown . In this study , the most effective intervention for promoting adoption of physical activity was the most intensive , involving six motivational interviews and a financial incentive A comparatively brief intervention ( one interview ) was only effective in the short term in around a third of participants Short term increases in physical activity were not maintained at one year follow up and even the most intensive intervention was ineffective in promoting long term adherence to increased physical activity . National and local government , health authorities , and primary healthcare teams should be cautious about current and future expenditure on , and implementation of , exercise prescription or referral BACKGROUND Using peer volunteers as delivery agents may improve translation of evidence -based physical activity promotion programs for older adults . This study examined whether tailored support from older peer volunteers could improve initiation and long-term maintenance of physical activity behavior . METHODS Participants were r and omized to 2 16-week , group-based programs : ( 1 ) peer-delivered , theory-based support for physical activity behavior change ; or ( 2 ) an intervention typically available in community setting s ( basic education , gym membership , and pedometer for self-monitoring ) , attention-matched with health education . Moderate-to-vigorous physical activity ( MVPA ) was assessed via daily self-report logs at baseline , at the end of the intervention ( 16 weeks ) , and at follow-up ( 18 months ) , with accelerometry validation ( RT3 ) in a r and om sub sample . RESULTS Seven peer volunteers and 81 sedentary adults were recruited . Retention at the end of the trial was 85 % and follow-up at 18 months was 61 % . Using intent-to-treat analyses , at 16 weeks , both groups had similar significant improvements in MVPA . At 18 months , the group supplemented with peer support had significantly more MVPA . CONCLUSIONS Trained peer volunteers may enhance long-term maintenance of physical activity gains from a community-based intervention . This approach has great potential to be adapted and delivered inexpensively in community setting Background Following an extensive recruitment campaign , a 16-week lunchtime intervention to increase walking was implemented with insufficiently physically active University employees to examine programme feasibility and the effects of the programme in increasing walking behaviour , and in improving well-being and work performance . Methods / design A feasibility study in which participants were r and omised to an immediate treatment or a delayed treatment control ( to start at 10 weeks ) group . For the first ten weeks of the intervention , participants took part in three facilitator-led group walks per week each of thirty minutes duration and were challenged to accumulate another sixty minutes of walking during the weekends . In the second phase of the intervention , the organised group walks ceased to be offered and participants were encouraged to self-organise their walks . Motivational principles were employed using contemporary motivational theory . Outcome measures ( including self-reported walking , step counts , cardiovascular fitness , general and work-related well-being and work performance ) were assessed at baseline , at the end of the 16-week intervention and ( for some ) four months after the end of the intervention . Process and outcome assessment s were also taken throughout , and following , the intervention . Discussion The results of the intervention will determine the feasibility of implementing a lunchtime walking programme to increase walking behaviour , well-being and performance in sedentary employees . If successful , there is scope to implement definitive trials across a range of worksites with the aim of improving both employee and organisational health . Trial registration Current Controlled Trials IS RCT N81504663 Mediation analyses in faith-based physical activity ( PA ) interventions targeting African-American adults are lacking . The purpose of this study was to examine the psychosocial mediators of a faith-based PA intervention with African-American adults . Churches were r and omly assigned to receive immediate or delayed ( 1-year later ) training in PA program implementation . A sub sample of participants from r and omly selected churches took part in telephone surveys at baseline and at 1 year . The primary outcome was percentage of participants meeting PA recommendations . MacKinnon 's product of coefficients was used to test for mediation . Participants ( n = 418 ) from 20 churches completed the baseline and 1-year follow-up surveys . There were no statistically significant changes in PA behavior at 1 year . The intervention had a marginally significant effect on increasing the amount of instrumental church support received by church members . However , none of the psychosocial variables tested were found to be significant mediators of the intervention . Mediation analyses provided insight into potential reasons as to why the Health-e-AME intervention did not change PA . The intervention did not successfully change the targeted mediators hypothesized to change PA . Potential reasons for these shortcomings as well as issues to address in future faith-based studies are discussed This paper reports on the cost-effectiveness of pedometer-based versus time-based Green Prescriptions in improving physical activity and health-related quality of life ( EQ-5D ) in a r and omised controlled trial of 330 low-active , community-based adults aged 65 years and over . Costs , measured in $ NZ ( NZ$1=A$0.83 , December 2008 ) , comprised public and private health care costs plus exercise-related personal expenditure . Based on intention-to-treat data at 12-month follow up , the pedometer group showed a greater increase in weekly leisure walking ( 50.6 versus 28.1min for the time-based group , adjusted means , P=0.03 ) . There were no significant between-group differences in costs . The incremental cost-effectiveness ratios , for the pedometer-based versus time-based Green Prescription , per 30min of weekly leisure walking and per quality -adjusted life year were , ( i ) when including only community care costs , $ 115 and $ 3105 , ( ii ) when including only exercise and community care costs , $ 130 and $ 3500 , and ( iii ) for all costs , -$185 and -$4999 , respectively . The cost-effectiveness acceptability curves showed that the pedometer-based compared with the time-based Green Prescription was statistically cost-effective , for the above cost categories , at the following quality -adjusted life year thresholds : ( i ) $ 30000 ; ( ii ) $ 30500 ; and ( iii ) $ 16500 . The additional program cost of converting one sedentary adult to an active state over a 12-month period was $ 667 . The outcomes suggest the pedometer-based Green Prescription may be cost-effective in increasing physical activity and health-related quality of life over 12 months in previously low-active older adults BACKGROUND Physical activity promotion is a priority , but contribution of physicians ' interventions is unclear . The effectiveness of the PEPAF ( " Experimental Program for Physical Activity Promotion " ) , which was implemented exclusively by physicians in routine primary care from October 2003 to December 2004 , was assessed . METHODS Fifty-six Spanish family physicians were r and omized to either the intervention ( n = 29 ) or st and ard care ( n = 27 ) arm of the trial . The physicians recruited 4317 physically inactive patients ( 2248 for intervention and 2069 for control protocol s ) from a systematic sample after assessing their physical activity in routine practice . Intervention physicians provided advice to all patients and a physical activity prescription to the subgroup attending an additional appointment ( 30 % ) . The main outcome measure was the change in physical activity measured by blinded nurses using the 7-Day Physical Activity Recall . Secondary outcomes included cardiorespiratory fitness and health-related quality of life . RESULTS At 6 months , intervention patients increased physical activity more than controls ( adjusted difference , 18 min/wk [ 95 % confidence interval , 6 - 31 min/wk ] ; metabolic equivalent tasks x hours per week , 1.3 [ 95 % CI , 0.4 - 2.2 ] ) . The proportion of the population achieving minimal physical activity recommendations was 3.9 % higher in the intervention group ( 1.2%-6.9 % ; number needed to treat , 26 ) . No differences were found in secondary outcomes . The effect of intervention was positively modified in subjects older than 50 years ( P < or = .01 ) and in the prescription subgroup ( P < .001 ) . CONCLUSIONS Family physicians were effective for increasing physical activity of primary care patients . Overall clinical effect was small but relevant for population public health . Within the intervention program , clinical ly relevant effects were seen in patients receiving a physical activity prescription . Trial Registration clinical trials.gov Identifier : NCT00131079 Background Limited data are available on the development , implementation and evaluation processes of physical activity promotion programmes among older adults . More integrative insights into interventions describing the planned systematic development , implementation and evaluation are needed . Methods and design The purpose of this study is to give an integrative insight into the development of the Active plus programme applying the six-step Intervention Mapping protocol . The Active plus programme consisted of two theory- and evidence -based tailored physical activity promotion interventions , both comprising three tailored letters delivered over four months and aim ed at raising awareness of insufficient physical activity , and stimulating physical activity initiation and maintenance among the over-fifties . The first intervention , the basic tailored intervention , provided tailored letters that intervened on the psychosocial determinants of physical activity . The second intervention , the intervention plus , provided the same tailored information but additionally provided tailored information about physical activity opportunities in the specific environment in which the older adults lived . This environment-based component also provided access to a forum and e-buddy system on a website . A plan for implementation and evaluation is also described . Discussion The planned development of the Active plus programme result ed in two theory- and evidence -based tailored physical activity interventions targeted at the over-fifties . Trial Registration Dutch Trial Register NTR OBJECTIVE We evaluate the 6-month efficacy of Keep Active Minnesota , a phone- and mail-based physical activity maintenance intervention design ed for use with adults age 50 to 70 years who have increased their physical activity within the past year . METHOD Participants ( N=1049 ) recruited in 2004 and 2005 from one large managed-care organization in Minnesota were r and omly assigned to either treatment ( N=523 ) or usual care ( N=526 ) with physical activity assessed using the Community Healthy Activities Model Program for Seniors question naire , and expressed as kcal/week expenditures . RESULTS Total physical activity at baseline was similar for treatment and usual care participants ( p<0.44 ) as was moderate/vigorous physical activity ( p<0.21 ) . Maintenance of physical activity was higher among treatment participants whose mean 6-month change in total kcal/week energy expenditure was -91 , compared to -683 for usual care participants ( p<0.002 ) . Mean 6-month change in kcal/week expenditure in moderate or vigorous activities was -49 for treatment participants , compared to -612 for usual care participants ( p<0.001 ) . CONCLUSIONS This phone- and mail-based physical activity maintenance intervention is efficacious at maintaining physical activity at 6 months Background Scotl and has a policy aim ed at increasing physical activity levels in the population , but evidence on how to achieve this is still developing . Studies that focus on encouraging real world participants to start physical activity in their setting s are needed . The Walking for Well-being in the West study was design ed to assess the effectiveness of a pedometer-based walking programme in combination with physical activity consultation . The study was multi-disciplinary and based in the community . Walking for Well-being in the West investigated whether Scottish men and women , who were not achieving the current physical activity recommendation , increased and maintained walking behaviour over a 12 month period . This paper outlines the rationale and design of this innovative and pragmatic study . Methods Participants were r and omised into two groups : Group 1 : Intervention ( pedometer-based walking programme combined with a series of physical activity consultations ) ; Group 2 : Waiting list control for 12 weeks ( followed by minimal pedometer-based intervention ) . Physical activity ( primary outcome ) was measured using pedometer step counts ( 7 day ) and the International Physical Activity Question naire ( long version ) . Psychological processes were measured using question naires relating to the Transtheoretical Model of Behaviour Change , m
Output:
| The most effective interventions applied a tailored approach to the type of PA and used telephone contact to provide feedback and to support changes in PA levels .
We found consistent evidence to support the effectiveness of remote and web 2.0 interventions for promoting PA .
These interventions have positive , moderate sized effects on increasing self-reported PA and measured cardio-respiratory fitness , at least at 12 months .
The effectiveness of these interventions was supported by moderate and high quality studies . |
MS212456 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND The European R and omised study of Screening for Prostate Cancer ( ERSPC ) has shown significant reductions in prostate cancer mortality after 9 years and 11 years of follow-up , but screening is controversial because of adverse events such as overdiagnosis . We provide up date d results of mortality from prostate cancer with follow-up to 2010 , with analyses truncated at 9 , 11 , and 13 years . METHODS ERSPC is a multicentre , r and omised trial with a predefined central ised data base , analysis plan , and core age group ( 55 - 69 years ) , which assesses prostate-specific antigen ( PSA ) testing in eight European countries . Eligible men aged 50 - 74 years were identified from population registries and r and omly assigned by computer generated r and om numbers to screening or no intervention ( control ) . Investigators were masked to group allocation . The primary outcome was prostate cancer mortality in the core age group . Analysis was by intention to treat . We did a secondary analysis that corrected for selection bias due to non-participation . Only incidence and no mortality data at 9 years ' follow-up are reported for the French centres . This study is registered with Current Controlled Trials , number IS RCT N49127736 . FINDINGS With data truncated at 13 years of follow-up , 7408 prostate cancer cases were diagnosed in the intervention group and 6107 cases in the control group . The rate ratio of prostate cancer incidence between the intervention and control groups was 1·91 ( 95 % CI 1·83 - 1·99 ) after 9 years ( 1·64 [ 1·58 - 1·69 ] including France ) , 1·66 ( 1·60 - 1·73 ) after 11 years , and 1·57 ( 1·51 - 1·62 ) after 13 years . The rate ratio of prostate cancer mortality was 0·85 ( 0·70 - 1·03 ) after 9 years , 0·78 ( 0·66 - 0·91 ) after 11 years , and 0·79 ( 0·69 - 0·91 ) at 13 years . The absolute risk reduction of death from prostate cancer at 13 years was 0·11 per 1000 person-years or 1·28 per 1000 men r and omised , which is equivalent to one prostate cancer death averted per 781 ( 95 % CI 490 - 1929 ) men invited for screening or one per 27 ( 17 - 66 ) additional prostate cancer detected . After adjustment for non-participation , the rate ratio of prostate cancer mortality in men screened was 0·73 ( 95 % CI 0·61 - 0·88 ) . INTERPRETATION In this up date the ERSPC confirms a substantial reduction in prostate cancer mortality attributable to testing of PSA , with a substantially increased absolute effect at 13 years compared with findings after 9 and 11 years . Despite our findings , further quantification of harms and their reduction are still considered a prerequisite for the introduction of populated-based screening . FUNDING Each centre had its own funding responsibility Importance Prostate cancer screening remains controversial because potential mortality or quality -of-life benefits may be outweighed by harms from overdetection and overtreatment . Objective To evaluate the effect of a single prostate-specific antigen ( PSA ) screening intervention and st and ardized diagnostic pathway on prostate cancer – specific mortality . Design , Setting , and Participants The Cluster R and omized Trial of PSA Testing for Prostate Cancer ( CAP ) included 419 582 men aged 50 to 69 years and was conducted at 573 primary care practice s across the United Kingdom . R and omization and recruitment of the practice s occurred between 2001 and 2009 ; patient follow-up ended on March 31 , 2016 . Intervention An invitation to attend a PSA testing clinic and receive a single PSA test vs st and ard ( unscreened ) practice . Main Outcomes and Measures Primary outcome : prostate cancer – specific mortality at a median follow-up of 10 years . Prespecified secondary outcomes : diagnostic cancer stage and Gleason grade ( range , 2 - 10 ; higher scores indicate a poorer prognosis ) of prostate cancers identified , all-cause mortality , and an instrumental variable analysis estimating the causal effect of attending the PSA screening clinic . Results Among 415 357 r and omized men ( mean [ SD ] age , 59.0 [ 5.6 ] years ) , 189 386 in the intervention group and 219 439 in the control group were included in the analysis ( n = 408 825 ; 98 % ) . In the intervention group , 75 707 ( 40 % ) attended the PSA testing clinic and 67 313 ( 36 % ) underwent PSA testing . Of 64 436 with a valid PSA test result , 6857 ( 11 % ) had a PSA level between 3 ng/mL and 19.9 ng/mL , of whom 5850 ( 85 % ) had a prostate biopsy . After a median follow-up of 10 years , 549 ( 0.30 per 1000 person-years ) died of prostate cancer in the intervention group vs 647 ( 0.31 per 1000 person-years ) in the control group ( rate difference , −0.013 per 1000 person-years [ 95 % CI , −0.047 to 0.022 ] ; rate ratio [ RR ] , 0.96 [ 95 % CI , 0.85 to 1.08 ] ; P = .50 ) . The number diagnosed with prostate cancer was higher in the intervention group ( n = 8054 ; 4.3 % ) than in the control group ( n = 7853 ; 3.6 % ) ( RR , 1.19 [ 95 % CI , 1.14 to 1.25 ] ; P < .001 ) . More prostate cancer tumors with a Gleason grade of 6 or lower were identified in the intervention group ( n = 3263/189 386 [ 1.7 % ] ) than in the control group ( n = 2440/219 439 [ 1.1 % ] ) ( difference per 1000 men , 6.11 [ 95 % CI , 5.38 to 6.84 ] ; P < .001 ) . In the analysis of all-cause mortality , there were 25 459 deaths in the intervention group vs 28 306 deaths in the control group ( RR , 0.99 [ 95 % CI , 0.94 to 1.03 ] ; P = .49 ) . In the instrumental variable analysis for prostate cancer mortality , the adherence-adjusted causal RR was 0.93 ( 95 % CI , 0.67 to 1.29 ; P = .66 ) . Conclusions and Relevance Among practice s r and omized to a single PSA screening intervention vs st and ard practice without screening , there was no significant difference in prostate cancer mortality after a median follow-up of 10 years but the detection of low-risk prostate cancer cases increased . Although longer-term follow-up is under way , the findings do not support single PSA testing for population -based screening . Trial Registration IS RCT N Identifier : IS RCT BACKGROUND The optimal upper limit of the normal range for prostate-specific antigen ( PSA ) is unknown . We investigated the prevalence of prostate cancer among men in the Prostate Cancer Prevention Trial who had a PSA level of 4.0 ng per milliliter or less . METHODS Of 18,882 men enrolled in the prevention trial , 9459 were r and omly assigned to receive placebo and had an annual measurement of PSA and a digital rectal examination . Among these 9459 men , 2950 men never had a PSA level of more than 4.0 ng per milliliter or an abnormal digital rectal examination , had a final PSA determination , and underwent a prostate biopsy after being in the study for seven years . RESULTS Among the 2950 men ( age range , 62 to 91 years ) , prostate cancer was diagnosed in 449 ( 15.2 percent ) ; 67 of these 449 cancers ( 14.9 percent ) had a Gleason score of 7 or higher . The prevalence of prostate cancer was 6.6 percent among men with a PSA level of up to 0.5 ng per milliliter , 10.1 percent among those with values of 0.6 to 1.0 ng per milliliter , 17.0 percent among those with values of 1.1 to 2.0 ng per milliliter , 23.9 percent among those with values of 2.1 to 3.0 ng per milliliter , and 26.9 percent among those with values of 3.1 to 4.0 ng per milliliter . The prevalence of high- grade cancers increased from 12.5 percent of cancers associated with a PSA level of 0.5 ng per milliliter or less to 25.0 percent of cancers associated with a PSA level of 3.1 to 4.0 ng per milliliter . CONCLUSIONS Biopsy-detected prostate cancer , including high- grade cancers , is not rare among men with PSA levels of 4.0 ng per milliliter or less -- levels generally thought to be in the normal range Prostate cancer ( PC ) screening remains controversial . We investigated whether screening reduces the difference in prostate cancer risk by socioeconomic status ( SES ) . In 1996 - 2011 , a total of 72,139 men from the Finnish R and omized Study of Screening for Prostate Cancer were analyzed . Outcome measures were PC incidence , mortality , and participation in screening . SES indicators were educational level , income , and home ownership status ( data obtained from the Statistics Finl and registry ) . The mean duration of follow-up was 12.7 years . Higher SES was associated with a higher incidence of low- to moderate-risk PC but with a lower risk of advanced PC . Higher education was associated with significantly lower PC mortality in both control and screening arms ( risk ratio = 0.48 - 0.69 ; P < 0.05 ) . Higher income was also associated with lower PC mortality but only in the control arm ( risk ratio = 0.45 - 0.73 ; P < 0.05 ) . There were no significant differences in SES gradient by arm ( Pinteraction = 0.33 and Pinteraction = 0.47 for primary vs. secondary education and primary vs. tertiary education , respectively ; Pinteraction = 0.65 and Pinteraction = 0.09 for low vs. intermediate income and low vs. high income , respectively ; and Pinteraction = 0.27 among home ownership status strata ) . Substantial gradients by SES in PC incidence and mortality were observed in the control arm . Higher SES was associated with overdiagnosis of low-risk PC and , conversely , lower risk of incurable PC and lower PC mortality . Special attention should be directed toward recruiting men with low SES to participate in population -based cancer screening Background : Screening for prostate cancer ( PC ) may save lives , but overdiagnosis and overtreatment are serious drawbacks . We aim ed to determine men ’s preferences for PC screening , and to elicit the trade-offs they make . Methods : A discrete choice experiment ( DCE ) was conducted among a population -based r and om sample of 1000 elderly men ( 55–75-years-old ) . Trade-offs were quantified with a panel latent class model between five PC screening aspects : risk reduction of PC-related death , screening interval , risk of unnecessary biopsies , risk of unnecessary treatments , and out-of-pocket costs . Results : The response rate was 46 % ( 459/1000 ) . Men were willing to trade-off 2.0 % ( CI : 1.6%–2.4 % ) or 1.8 % ( CI : 1.3%–2.3 % ) risk reduction of PC-related death to decrease their risk of unnecessary treatment or biopsy with 10 % , respectively . They were willing to pay [ euro ] 188 per year ( CI : [ euro ] 141–[euro ] 258 ) to reduce their relative risk of PC-related death with 10 % . Preference heterogeneity was substantial , with men with higher educational levels having a lower probability to opt for PC screening than men with lower educational levels . Conclusion : Men were willing to trade-off some risk reduction of PC-related death to be relieved of the burden of biopsies or unnecessary treatments . Increasing knowledge on overdiagnosis and overtreatment , especially for men with lower educational levels , is warranted to prevent unrealistic expectations from PC screening BACKGROUND Evidence of the potential impact of systematic screening for prostate cancer ( PCa ) on health-related quality of life ( HRQoL ) at a population -based level is currently scarce . OBJECTIVE This study aims to quantify the long-term HRQoL impact associated with screening for PCa . DESIGN , SETTING , AND PARTICIPANTS Postal question naire surveys were conducted in 1998 , 2000 , 2004 , and 2011 among men in the Finnish PCa screening trial diagnosed with PCa ( total n=7011 ) and among a r and om sub sample of the trial population ( n=2200
Output:
| After a median follow-up of 10 years , there was no significant difference in prostate cancer-specific mortality in men receiving care by general practice s r and omised to a single PSA screening intervention compared with men receiving care … RETURN TO |
MS212457 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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***EXAMPLES***
Input: This study examined how two types of public education programs influenced how the public perceived persons with mental illness , their potential for violence , and the stigma of mental illness . A total of 161 participants were r and omly assigned to one of three programs : one that aim ed to combat stigma , one that highlighted the association between violence and psychiatric disorders , and a control group . Participants who completed the education-about-violence program were significantly more likely to report attitudes related to fear and dangerousness , to endorse services that coerced persons into treatment and treated them in segregated areas , to avoid persons with mental illness in social situations , and to be reluctant to help persons with mental illness Due to the prevalence and serious consequences associated with mental illness stigma , a number of educational interventions have been developed to decrease stigma . One potential intervention is administering brief simulations of auditory hallucinations , but no empirical evaluations have been published . This research examined the efficacy of a brief simulation on stigma across two listening conditions . After completing a stigma measure , participants ( N = 127 ) listened to a simulation and were r and omly assigned to one of two listening conditions : ( 1 ) sitting in a research lab , or ( 2 ) ambulating around a college campus completing two tasks . All participants then completed the stigma measure a second time . Regardless of listening condition , the simulations led to changes on two aspects of stigma — less willingness to help/interact and stronger attitudes for forcing treatment on those with mental illness . These findings suggest that brief simulations require additional careful evaluation of their efficacy prior to wide implementation Acceptance and commitment therapy ( ACT ) has previously been shown to alter stigmatizing attitudes and to be relatively useful for psychologically inflexible participants . The present study is the first to bring those two findings together by comparing ACT to an education intervention for reducing stigma toward people with psychological disorders , and examining whether results differ for psychologically inflexible versus flexible individuals . A sample of college students ( N = 95 ) was r and omly assigned to a 2(1)2h ACT or educational workshop . Measures were taken before and after the workshop and at a 1-month follow-up . ACT reduced mental health stigma significantly regardless of participants ' pre-treatment levels of psychological flexibility , but education reduced stigma only among participants who were relatively flexible and non-avoidant to begin with . Acceptance could be an important avenue of exploration for stigma research ers PURPOSE This study examined the effectiveness of an intervention to reduce explicit and implicit stigma-relevant attitudes toward mental illness and treatment-seeking and behavioural indicators of willingness to seek treatment . METHODS Adolescents were r and omly assigned to the experimental ( education about mental illness and treatment involving psychoeducation and contact ( via DVD ) with an affected individual ) or control intervention ( education about tobacco ) . RESULTS Findings suggest the stigma intervention was effective at reducing explicit but not implicit stigma-relevant attitudes . As hypothesized , participants receiving the experimental intervention reported less explicit stigma toward treatment and greater openness to personally seek treatment if they had also reported prior mental health treatment . CONCLUSIONS AND IMPLICATION S These findings support the potential for a brief educational intervention among adolescents to reduce negative attitudes toward mental health treatment , but raise questions about how to effectively address implicit stigma as well as the importance of translating stigma reduction into behavior changes Stigma reduction programs are dominated by a biomedical model that presents depression as a medical illness . Alternately , a context ual model emphasizes that one should not be blamed for environmental influences . This study compared biomedical , context ual , and control stigma reduction programs to each other and to a no-program control . The main hypotheses were that the context ual program would have the greatest impact and that a match between participants ’ beliefs about depression and the model presented would moderate this effect . Seventy-four participants were r and omized to the 3 programs and 12 participants served as a no-program control . The context ual and control programs reduced stigma significantly compared with the no-program control , whereas the biomedical program did not . Beliefs about depression moderated this effect only for the biomedical condition . Context ual and control programs seem to be effective but a biomedical model may be risky for those who disagree with the model . Theoretical implication s are discussed OBJECTIVE This study evaluated a consumer delivered anti-stigma presentation , In Our Own Voice ( IOOV ) , with Masters of Social Work ( MSW ) students , replicating a previous study with undergraduates . METHODS Thirty MSW students completed pre and post surveys to measure changes in attitude , knowledge and social distance after the presentation . RESULTS Paired sample s t-tests showed increases in attitude ( p < .001 ) , knowledge ( p < .05 ) , and social distance ( p < .001 ) . Compared with previous research on undergraduate students , MSW students scored higher on all three pre-test measures ( all p < .001 ) . CONCLUSIONS The results further support the effectiveness of IOOV and indicate that graduate level helping professionals can benefit from anti-stigma programs . Future research should go beyond self-report knowledge and attitude evaluation , test the efficacy of the components of the IOOV program ( video , contact with presenters ) , and test the lasting effects of the program ABSTRACT This study examines the impact of two versions of anti-stigma programs — education and contact — presented on videotape . A total of 244 people were r and omly assigned to education or contact conditions and completed pre-test , post-test , and follow-up measures of stereotypes . Results suggest that the education videotape had limited effects , mostly showing improvement in responsibility ( people with mental illness are not to blame for their symptoms and disabilities ) . Watching the contact videotaped showed significant improvement in pity , empowerment , coercion , and segregation . Contact effects were evident at post-test and 1 week follow-up . Implication s of these findings for future research are discussed OBJECTIVE We design ed our study to assess if computer-assisted anti-stigma interventions can be effective in reducing the level of psychiatric stigma in a sample of special education university students . METHODS We enrolled 193 graduate students . They had two study visits with an interval of 6 months . The participants were r and omly distributed into three study groups : 76 students read anti-stigma printed material s ( reading group , RG ) , and 69 studied an anti-stigma computer program ( program group , PG ) , and 48 students were in a control group ( CG ) and received no intervention . We used the Bogardus scale of social distance ( BSSD ) , the community attitudes toward the mentally ill ( CAMI ) question naire , and the psychiatric knowledge survey ( PKS ) as the main outcome measures . RESULTS After the intervention BSSD , CAMI and PKS scores significantly improved both in RG and PG . After 6 months in RG two out of three CAMI subscales and PKS scores were not different from the baseline . In PG all stigma and knowledge changes remained significant . CONCLUSIONS This study demonstrated that computers can be an effective mean in changing attitudes of students toward psychiatric patients . PRACTICE IMPLICATION S A computer-mediated intervention has the potential for educating graduate students about mental disease and for reducing psychiatric stigma BACKGROUND Little is known about the efficacy of educational interventions for reducing the stigma associated with depression . AIMS To investigate the effects on stigma of two internet depression sites . METHOD A sample of 525 individuals with elevated scores on a depression assessment scale were r and omly allocated to a depression information website ( BluePages ) , a cognitive-behavioural skills training website ( MoodGYM ) or an attention control condition . Personal stigma ( personal stigmatising attitudes to depression ) and perceived stigma ( perception of what most other people believe ) were assessed before and after the intervention . RESULTS Relative to the control , the internet sites significantly reduced personal stigma , although the effects were small . BluePages had no effect on perceived stigma and MoodGYM was associated with an increase in perceived stigma relative to the control . Changes in stigma were not mediated by changes in depression , depression literacy or cognitive-behavioural therapy literacy . CONCLUSIONS The internet warrants further investigation as a means of delivering stigma reduction programmes for depression This study examines the effects of Entertainment-Education strategy on knowledge acquisition about schizophrenia and stigma reduction , using pretest posttest control group and 2 X 3 ( advocate 's perspective X message style ) between-subjects factorial design . Participants watched an accurate and empathetic movie portrayal of schizophrenia , followed by an educational trailer . Participants ( N= 165 ) were r and omly assigned to one of eight conditions ( six manipulated conditions , control , a group who watched a trailer prior to the movie ) . Results showed that viewing an accurate and empathetic movie portrayal increased knowledge . The educational trailer increased not only knowledge acquisition but influenced stigma reduction . Structural equation modeling analysis revealed that entertainment and educational value of the movie mediated stigma reduction . Implication s of this study to the mental health research and the design of Entertainment-Education contents are discussed Rreliminary evidence suggests that mental health consumers can successfully serve as peer companions , case management aides , case managers , job coaches , and drop-in center staff . However , few empirical investigations have addressed the use of consumers to train mental health professionals . This project employed a r and omized design to test the effects of using consumers as trainers for mental health service providers . Fifty-seven state mental health professionals participated in a two-day training design ed to acquaint trainees with the attitudes and knowledge necessary for delivering assertive case management services . Participants were r and omly assigned to one of two conditions : one in which they received the second day of training from a consumer and the other involving training by a nonconsumer . Analyses revealed that post-training attitudes were significantly more positive for those participants trained by the consumer . Subjective evaluations also reflected positive reactions to the use of consumers as trainers . Implication s for further use of mental health consumers as trainers are explored The effects of stereotype suppression on psychiatric stigma were investigated in two studies . In experiment 1 , 52 participants were presented with a photograph of someone labeled with schizophrenia and instructed to write a passage describing a day in that person 's life . Half of the participants were instructed to avoid using schizophrenia-related stereotypes in their passages ( the stereotype suppression condition ) . Participants were then presented with a photograph of a different individual labeled with schizophrenia and asked to write another passage with stereotype suppression instructions omitted . The results showed that while stereotype suppression occurred for the first passage , the expected rebound effects were not observed in the second passage . Furthermore , the results were unchanged when participants ' prior experience with persons with mental illness was considered . In a second study , the effects of stereotype suppression on behavior ( i.e. seating distance from a person with schizophrenia ) were examined in 58 participants . While the stereotype suppression instructions result ed in less stereotypical passages , replicating the results of study 1 , no rebound effects on behavior were observed . A non-significant trend was observed whereby previous contact with persons with mental illness was associated with less social distance from someone with schizophrenia . Implication s of the findings for reducing psychiatric stigma are discussed BACKGROUND Education is integral to reducing stigma toward the mentally ill . Medical educators have a key role in delivering education that reduces that stigma . Undergraduate psychiatric training and specific education programs are both effective in reducing stigma . However , many students are exposed to concepts of mental illness at a much earlier stage in their education . No previous study has explored the effect of intervention such as role-play on student attitudinal development . OBJECTIVES This study 's objective was to identify whether undergraduate role-play exercises featuring mental illness influenced development of attitudes toward the mentally ill . METHODS A r and omized controlled trial was used to compare attitudinal scores between students exposed to a mental illness role-play as part of routine teaching and a control group that did not receive the teaching . RESULTS A total of 332 students provided data . There were no between-group differences for any attitudinal scores , although gender ( being female ) and experience of mental illness were associated with more positive attitudinal scores . CONCLUSIONS Single high-intensity routine teaching sessions such as role-play involving metal illness do not influence student attitudes Trauma risk management ( TRiM ) is an intensive posttraumatic stress disorder ( PTSD ) psychoeducational management strategy based on peer-group risk assessment developed by the UK Royal Navy ( RN ) . TRiM seeks to modify attitudes about PTSD , stress , and help-seeking and trains military personnel to identify at-risk individuals and refer them for early intervention . This quasiexperimental study found that TRiM training significantly improved attitudes about PTSD , stress , and help-seeking from TRiM-trained personnel . There was a nonsignificant effect on attitudes to seeking help from normal military support networks and on general health . Within both the military and civilian population s , stigma is a serious issue preventing help-seeking and reducing quality of life . The results suggest that TRiM is a promising antistigma program within organizational setting Mental illness stigma is quite prevalent with dire consequences . A number of interventions to decrease stigma have been formulated , but have variable effectiveness and limited dissemination . This research examined the impact of two brief interventions : a film depicting individuals with schizophrenia ( filmed contact ) and a simulation of auditory hallucinations . Participants ( N = 143 ) were r and omly assigned to one of three interventions : ( 1 ) filmed contact , ( 2 ) simulation , or ( 3 ) no intervention , and completed two stigma measures prior to , immediately after , and 1 week after the intervention . The filmed contact intervention led to decreases in stigma which persisted across 1 week . However , the simulation led to increases in stigma . The results suggest that a filmed contact intervention may decrease two aspects of mental illness stigma ( social distance and negative emotions ) , which has implication s for wide dissemination . The efficacy of a hallucination simulations intervention remains dubious OBJECTIVE This study was design ed to investigate the efficacy of a
Output:
| RESULTS Overall , both education and contact had positive effects on reducing stigma for adults and adolescents with a mental illness .
However , contact was better than education at reducing stigma for adults .
For adolescents , the opposite pattern was found : education was more effective .
Overall , face-to-face contact was more effective than contact by video . |
MS212458 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Anaemic status is determined by haemoglobin using the HemoCue system or haematocrit measurements , and a threefold conversion is commonly used to equate the two measures ( haemoglobin = haematocrit/3 ) . The validity of this conversion in malaria endemic setting s was assessed . Methods Concurrent measures of haemoglobin and centrifuged haematocrit in children aged 6–59 months were compared by modelling the difference between the two measures against their average . A r and om effects linear regression of the difference of the measures on their average was used to describe the line of best agreement and 95 % limits of agreement for these two measures over a range of values after adjusting for statistically significant covariates . Results There was a consistent bias between the two measures , with haemoglobin less than haematocrit/3 in 87 % ( 899/1,030 ) of observations . This difference was non-uniform , decreasing with the average measure , i.e. less difference at higher haemoglobin and haematocrit values . In these studies , use of haematocrit would have underestimated the prevalence of anaemia by misclassifying 10 % ( 89/920 ) of individuals with haemoglobin < 11 g/dl , 66 % ( 252/380 ) of individuals with haemoglobin < 8 g/dl and 100 % ( 23/23 ) of individuals with haemoglobin < 5 g/dl . The mean difference between the measures was greater in males than females , increased with age between 6–59 months , and was greater in the wet than dry season suggesting that the relationship between haemoglobin and haematocrit may be modified by exposure to malaria . Conclusion The regression model indicated that the st and ard threefold conversion from haematocrit to haemoglobin underestimates the prevalence of haemoglobin < 11 g/dl in children under five years of age in malaria endemic setting s. This bias was more acute for more severe anaemia defined by haemoglobin < 8 g/dl and haemoglobin < 5 g/dl . This has important implication s for the comparability of studies using these different measures . Direct determination of haemoglobin should be the measurement of choice for assessing anaemia outcomes in malaria intervention trials and surveys BACKGROUND The published literature on cluster r and omized trials focuses on outcomes that are either continuous or binary . In many trials , the outcome is an incidence rate , such as mortality , based on person-years data . In this paper we review methods for the analysis of such data in cluster r and omized trials and present some simple approaches . METHODS We discuss the choice of the measure of intervention effect and present methods for confidence interval estimation and hypothesis testing which are conceptually simple and easy to perform using st and ard statistical software . The method proposed for hypothesis testing applies a t-test to cluster observations . To control confounding , a Poisson regression model is fitted to the data incorporating all covariates except intervention status , and the analysis is carried out on the residuals from this model . The methods are presented for unpaired data , and extensions to paired or stratified clusters are outlined . RESULTS The methods are evaluated by simulation and illustrated by application to data from a trial of the effect of insecticide-impregnated bednets on child mortality . CONCLUSIONS The techniques provide a straightforward approach to the analysis of incidence rates in cluster r and omized trials . Both the unadjusted analysis and the analysis adjusting for confounders are shown to be robust , even for very small numbers of clusters , in situations that are likely to arise in r and omized trials A project testing the efficacy of insecticide (permethrin)-impregnated bed nets , compared with impregnated door and window curtains , residual house spraying , and a control group was implemented in 12 village clusters in the Nsukka Local Government Area of Enugu State , Nigeria , using epidemiologic and entomologic indicators . The appropriate material s and services were given free to all families . During the first year of study , three monitoring exercises were carried out in a r and om selection of homes where children under 5 years of age resided . Information was collected on perceived effectiveness of the interventions , condition of nets and curtains , reasons for not sleeping under nets , and recall of steps required in caring for nets and curtains . Bed nets were perceived as more effective in reducing mosquito bites compared with the two other interventions . At the last monitoring period , which occurred a few weeks before a re-impregnation exercise , respondents also perceived bed nets to be most effective in preventing malaria . These findings coincided with epidemiologic evidence . Curtains , especially those at doors , were more likely to be torn and dirty than bed nets . Although holes would not reduce the effectiveness of the insecticide , they could reduce the ' beauty ' of the curtains , a perceived benefit that initially attracted villagers to both curtains and nets . Bed net owners reported significantly less frequent use of other mosquito control measures in their homes than did members of the other groups . Finally , bed net users demonstrated increased knowledge of use and care steps than did those with curtains . These findings suggested a high level of social acceptability of bed nets , and point to the need to test their acceptability further under conditions where people would pay for nets and communities would manage distribution and re-impregnation systems Trials were undertaken in a hypoendemic area of malaria in an area bordering Vietnam , in Napo County of Guangxi Zhuang Autonomous Region , China . The aim was to compare the relative cost effectiveness of DDT residual spraying and of bednets impregnated with deltamethrin in the malaria control program . The trials were divided into three subgroups : ( 1 ) two farming areas and one coal mining area with a total population > 20,000 , where the trial consisted of mass bednets impregnated with deltamethrin 15 mg/m2 net surface once a year , ( 2 ) one farming area with a population of approximately 3,600 where DDT residual spraying at 2g/m2 was carried out twice a year in May and August ; ( 3 ) one farming area and one coal mining village with a population of > 4,000 were used as a control . The malaria vector population consisted mainly of Anopheles minimus and An . anthropophagus with a small contribution from An . sinensis . After bednets were impregnated with deltamethrin the mosquitos resting on the surface of the bednets decreased significantly , although there was less effect on the total vector population . The results showed that malaria incidence decreased significantly both in areas where impregnated bednets were used and in areas where residual spraying was undertaken . The positive IFAT rates of residents who slept under impregnated bednets decreased significantly in farming areas , especially in that area where bednet impregnation as a vector control measure had been undertaken for two years , but there was no change in the IFAT rate in DDT sprayed or control areas . ( ABSTRACT TRUNCATED AT 250 WORDS This study from two districts of Orissa State which are endemic for Plasmodium falciparum transmitted by Anopheles fluviatilis and A. culicifacies investigated the impact of dichlorodiphenyl trichloroethane ( DDT ) indoor residual spraying , in view of the ongoing discussion on phasing out DDT in India . Based on their high annual parasite incidence and logistical considerations , 26 villages in Malkangiri and 28 in Koraput district were selected for DDT spraying . For comparison , six and four unsprayed villages were chosen from the same districts . In each district , the prevalence of malaria infection and incidence of malaria fever , indoor resting density and parous rate of the vectors , and their susceptibility to DDT were monitored in six and three villages selected r and omly from the sprayed and unsprayed groups respectively . Anopheles fluviatilis was susceptible to DDT while A. culicifacies was resistant . DDT residual spraying with 1 g/m(2 ) , was carried out in October-November 2001 . Spraying 74 - 86 % of human dwellings and 100 % of cattle sheds brought down the indoor resting density of A. fluviatilis by 93 - 95 % . This was associated with a significant reduction of incidence of malaria fever as well as prevalence of malaria infection from November to February in both districts . The spraying also seemed to impact on vector longevity , and a residual effect of DDT on the sprayed walls was observed up to 10 - 12 weeks despite re-plastering . Hence DDT spraying can still be an effective tool for controlling fluviatilis-transmitted malaria . Although this species is exophilic , its nocturnal resting behaviour facilitates its contact with the sprayed surfaces . DDT is still useful for residual spraying in India , particularly in areas where the vectors are endophilic and not resistant We conducted a community-r and omized controlled trial in Pakistan to determine the efficacy of indoor residual spraying with alphacypermethrin ( ' Fendona ' , Cyanamid , NJ , USA ) , applied at 25 mg/m2 , to prevent falciparum and vivax malaria . Wettable powder ( WP ) and suspension concentrate ( SC ) formulations were tested against an unsprayed control in an irrigated rice-growing area of Sheikhupura district , Punjab province . The study area of 180 km2 was divided into nine sectors , which were assigned at r and om to control , WP , or SC treatments in replicates of 3 . Sentinel villages were selected from each sector for entomological and disease monitoring . Malaria was monitored by fortnightly active case detection ( ACD ) and by cross- sectional parasite surveys on schoolchildren . Mosquito population s were monitored by space spraying of rooms and by cattle-l and ing catches . The spray campaign took place in June 1997 and covered 96 % of compounds . During the 7 months after spraying , the incidence of falciparum malaria was 95 % lower and that of vivax malaria 80 % lower in WP-sprayed than unsprayed sectors . Similar results were obtained for sectors sprayed with the SC formulation . Cross-sectional surveys gave estimates of efficacy comparable to those obtained by ACD . Anopheles culicifacies was 80 % less abundant and A.stephensi , the predominant anopheline , was up to 68 % less abundant in sprayed areas over the 7-month period . Reductions in anopheline parous rates indicated that the single-spray treatment was effective for the entire transmission season . Sprayed surfaces lacked odour , which contributed to the popularity of the campaign . Alphacypermethrin is a promising insecticide for the control of malaria in Pakistan and South Asia generally This study compares the effectiveness and cost-effectiveness of indoor residual house-spraying ( IRS ) and insecticide-treated bednets ( ITNs ) against infection with Plasmodium falciparum as part of malaria control in the highl and s of western Kenya . Homesteads operationally targeted for IRS and ITNs during a district-based emergency response undertaken by an international relief agency were selected at r and om for evaluation . Five hundred and ninety homesteads were selected ( 200 with no vector control , 200 with IRS and 190 with ITNs ) . In July 2000 , residents in these homesteads were r and omly sample d according to three age-groups : 6 months-4 years , 5 - 15 years , and > 15 years for the presence of P. falciparum antigen ( Pf HRP-2 ) using the rapid whole blood immunochromatographic test ( ICT ) . The prevalence of P. falciparum infection amongst household members not protected by either IRS or ITN was 13 % . Sleeping under a treated bednet reduced the risk of infection by 63 % ( 58 - 68 % ) and sleeping in a room sprayed with insecticide reduced the risk by 75 % ( 73 - 76 % ) . The economic cost per infection case prevented by IRS was US$ 9 compared to US$ 29 for ITNs . This study suggests that IRS may be both more effective and cheaper than ITNs in communities subjected to low , seasonal risks of infection and as such should be considered as part of the control armamentarium for malaria prevention Malaria is one of the leading causes of morbidity and mortality in the developing world and a major public health problem in India . Disillusioned by in-house residual spraying ( IRS ) , and increasingly aware that insecticide-treated nets ( ITNs ) have proved to be effective in reducing malaria mortality and morbidity in various epidemiological setting s , policy-makers in India are keen to identify which is the more cost-effective malaria control intervention . A community r and omised controlled trial was set up in Surat to compare the effectiveness and efficiency of IRS and ITNs . Both control strategies were shown to be effective in preventing malaria over the base-case scenario of early diagnosis and prompt treatment . The mean costs per case averted for ITNs was statistically significantly lower ( Rs . 1848 , 1567 - 2209 ; US$ 52 ) than IRS ( Rs . 3121 , 2386 - 4177 , US$ 87 ) . The incremental cost-effectiveness ratio for ITNs over IRS was Rs . 799 ( US$ 22 ) . The conclusions were robust to changes in assumptions . This study exp and s the scope of recent comparative economic evaluations of ITNs and IRS , since it was carried out in a low mortality malaria endemic area In an intensely malarious area in north-east Tanzania , microencapsulated lambdacyhalothrin was used in four villages for treatment of bednets ( provided free of charge ) and in another four villages the same insecticide was used for house spraying . Another four villages received neither intervention until the end of the trial but were monitored as controls . Bioass
Output:
| Historical and programme documentation has clearly established the impact of IRS .
However , the number of high- quality trials are too few to quantify the size of effect in different transmission setting s. The evidence from r and omized comparisons of IRS versus no IRS confirms that IRS reduces malaria incidence in unstable malaria setting s , but r and omized trial data from stable malaria setting s is very limited . |
MS212459 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Severe borderline personality disorder is associated with a very high psychosocial and economic burden . Current treatment guidelines suggest that several manualized treatments , including day hospital Mentalization-Based Treatment ( MBT-DH ) , are effective in these patients . However , only two r and omized controlled trials have compared manualized MBT-DH with treatment as usual . Given the relative paucity of data supporting the efficacy and cost-effectiveness of MBT-DH , the possible influence of research er allegiance in one of the trials , and potential problems with the generalization of findings to mental health systems in other countries , this multi-site r and omized trial aims to investigate the efficacy and cost-effectiveness of manualized MBT-DH compared to manualized specialist treatment as usual in The Netherl and s. Methods / design The trial is being conducted at two sites in The Netherl and s. Patients with a DSM-IV-TR diagnosis of borderline personality disorder and a score of ≥ 20 on the Borderline Personality Disorder Severity Index were r and omly allocated to MBT-DH or treatment as usual . The MBT-DH program consists of a maximum of 18 months ’ intensive treatment , followed by a maximum of 18 months of maintenance therapy . Specialist treatment as usual is provided by the City Crisis Service in Amsterdam , a service that specializes in treating patients with personality disorders , offering manualized , non-MBT interventions including family interventions , Linehan training , social skills training , and pharmacotherapy , without a maximum time limit . Patients are assessed at baseline and subsequently every 6 months up to 36 months after the start of treatment . The primary outcome measure is the frequency and severity of manifestations of borderline personality disorder as assessed by the Borderline Personality Disorder Severity Index . Secondary outcome measures include parasuicidal behaviour , symptomatic distress , social and interpersonal functioning , personality functioning , attachment , capacity for mentalizing and quality of life . Cost-effectiveness is assessed in terms of the cost per quality -adjusted life year . Outcomes will be analyzed using multilevel analyses based on intention-to-treat principles . Discussion Severe borderline personality disorder is a serious psychological disorder that is associated with high burden . This multi-site r and omized trial will provide further data concerning the efficacy and cost-effectiveness of MBT-DH for these patients .Trial registration Background / aim Day centres for people with psychiatric disabilities need to be evaluated for effectiveness in order to provide the best possible support . This study aim ed at investigating the effectiveness of a tailor-made intervention to improve day centre services for people with psychiatric disabilities . Methods The intervention was devised to bridge identified gaps in the services and lasted for 14 months . Eight centres were allotted to the intervention ( 55 attendees ) or comparison condition ( 51 attendees ) . Fidelity to the intervention and major events in the day centres were assessed . The outcomes were degree of meaningfulness found in the day centre occupations , satisfaction with the rehabilitation received , satisfaction with everyday occupations and quality of life . Results The fidelity to the intervention was good , but more positive events , such as new occupational opportunities , had taken place in the comparison units . No differences were identified between the intervention and the comparison group regarding changes from baseline to the 14-month follow-up in perceived meaningfulness among day centre occupations , satisfaction with everyday occupations or quality of life . Conclusions The intervention seemed ineffective , but the positive events in the comparison group resembled the measures included in the tailor-made interventions . This first intervention study in the day centre context has hopefully helped to generate hypotheses and methods for future research Background Although psychotherapy is considered the treatment of choice for patients with personality disorders ( PDs ) , there is no consensus about the optimal level of care for this group of patients . This study reports the results from the 6-year follow-up of the Ullevål Personality Project ( UPP ) , a r and omized clinical trial comparing outpatient individual psychotherapy with a long-term step-down treatment program that included a short-term day hospital treatment followed by combined group and individual psychotherapy . Methods The UPP included 113 patients with PDs . Outcome was evaluated after 8 months , 18 months , 3 years and 6 years and was based on a wide range of clinical measures , such as psychosocial functioning , interpersonal problems , symptom severity , and axis I and II diagnoses . Results At the 6-year follow-up , there were no statistically significant differences in outcome between the treatment groups . Effect sizes ranged from medium to large for all outcome variables in both treatment arms . However , patients in the outpatient group had a marked decline in psychosocial functioning during the period between the 3- and 6-year follow-ups ; while psychosocial functioning continued to improve in the step-down group during the same period . This difference between groups was statistically significant . Conclusions The findings suggest that both hospital-based long-term step-down treatment and long-term outpatient individual psychotherapy may improve symptoms and psychosocial functioning in poorly functioning PD patients . Social and interpersonal functioning continued to improve in the step-down group during the post-treatment phase , indicating that longer-term changes were stimulated during treatment . Trial registration NCT00378248 Background Day-hospital-based treatment programmes have been recommended for poorly functioning patients with personality disorders ( PD ) . However , more research is needed to confirm the cost-effectiveness of such extensive programmes over other , presumably simpler , treatment formats . Methods This study compared health service costs and psychosocial functioning for PD patients r and omly allocated to either a day-hospital-based treatment programme combining individual and group psychotherapy in a step-down format , or outpatient individual psychotherapy at a specialist practice . It included 107 PD patients , 46 % of whom had borderline PD , and 40 % of whom had avoidant PD . Costs included the two treatment conditions and additional primary and secondary in- and outpatient services . Psychosocial functioning was assessed using measures of global ( observer-rated GAF ) and occupational ( self-report ) functioning . Repeated assessment s over three years were analysed using mixed models . Results The costs of step-down treatment were higher than those of outpatient treatment , but these high costs were compensated by considerably lower costs of other health services . However , costs and clinical gains depended on the type of PD . For borderline PD patients , cost-effectiveness did not differ by treatment condition . Health service costs declined during the trial , and functioning improved to mild impairment levels ( GAF > 60 ) . For avoidant PD patients , considerable adjuvant health services exp and ed the outpatient format . Clinical improvements were nevertheless superior to the step-down condition . Conclusion Our results indicate that decisions on treatment format should differentiate between PD types . For borderline PD patients , the costs and gains of step-down and outpatient treatment conditions did not differ . For avoidant PD patients , the outpatient format was a better alternative , leaning , however , on costly additional health services in the early phase of treatment . Trial registration Clinical Trials Background : For patients with cluster B personality disorders there is no consensus regarding the optimal treatment setting . The aim of this study was to compare the effectiveness of different psychotherapeutic setting s for patients with cluster B personality disorders , i.e. outpatient , day hospital , and inpatient treatment . Methods : The study was conducted between March 2003 and June 2008 in 6 mental health care centres in the Netherl and s , with a sample of 207 patients with a DSM-IV-TR axis II cluster B diagnosis . Patients were assigned to 3 different setting s of psychotherapeutic treatment and effectiveness was assessed at 18 months after baseline . An intention-to-treat analysis was conducted for psychiatric symptoms ( Brief Symptom Inventory ) , psychosocial functioning ( Outcome Question naire-45 ) , and quality of life ( EQ-5D ) , using multilevel statistical modelling . As the study was non-r and omised , the propensity score method was used to control for initial differences . Results : Patients in all 3 setting s improved significantly in terms of psychiatric symptoms , social and interpersonal functioning , and quality of life 18 months after baseline . The inpatient group showed the largest improvements . The comparison of outpatient and inpatient treatment regarding psychiatric symptoms showed a marginally significant result ( p = 0.057 ) in favour of inpatient treatment . Conclusions : Patients with cluster B personality disorders improved in all investigated treatment setting s , with a trend towards larger improvements of psychiatric symptoms in the inpatient setting compared to the outpatient setting . Specialised inpatient treatment should be considered as a valuable treatment option for cluster B personality disorders , both in research and in clinical practice OBJECTIVE In 2006 the psychosomatic day hospital for the treatment of acute mental illness of elderly people opened as the first clinic of its kind in Germany . The aim of this study was to determine treatment effectiveness and identify possible effects on health care utilization . METHODS Design ed as a naturalistic study with waiting time before admission as a control condition , the primary outcome was the level of depressive symptoms as measured by the hospital anxiety and depression scale . Secondary outcomes were depressive and somatoform symptoms and syndromes as measured with the patient health question naire , patient perception of interpersonal problems and health care use before and after treatment . RESULTS After treatment significant improvement ( p<0.01 ) with moderate effect sizes ( ES ) was found in all variables from admission to discharge ( ES from 0.3 to 0.8 ) and also to follow-up ( ES from 0.2 to 0.6 ) . Improvement remained stable at follow-up . Furthermore , after psychosomatic treatment a reduction in medical service usage was visible . Number of consultations ( pre : 13 , post : 9 ) , number and length of hospital stays ( pre : 1 , 7 weeks , post : 0 , 3 weeks ) were both significantly ( p<0.001 ) reduced six months after treatment as compared to the period six months prior to treatment . CONCLUSION Results indicate that the psychosomatic day hospital treatment of the elderly is successful . Reduced usage of health care and the lower costs for day hospital treatment compared to inpatient treatment point to a positive cost-effect-ratio . Exp and ing this psychosomatic intervention would be useful in reducing the current gap in mental health care for the elderly BACKGROUND Presently few studies demonstrate improved outcomes in patients with schizophrenia treated in day rehabilitation centres . One reason is the absence of an evidence based protocol for rehabilitation in such centres . Hence further research is required to assess whether such a protocol will improve psychosocial outcomes . AIMS We performed a controlled evaluation study of a protocol based rehabilitation day program ( RDC ) for persons suffering from schizophrenia . METHODS Patients from the experimental group ( N=50 ) were treated within the RDC for a 6 month period . The control group were patients on the waiting list for the RDC . Quality of life ( MANSA ) , social functioning ( OSA ) and self-esteem ( Rosenberg ) were measured before and after the intervention . RESULTS Statistically significant improvement was shown in social functioning measured by OSA ( F(1,96)=33.7 ; p<0.001 ) , quality of life measured by MANSA ( F(1,96)=69.3 ; p<0.001 ) and self esteem measured by Rosenberg scale ( F(1,96)=84.5 ; p<0.001 ) for patients treated in the RDC compared with the control group , conversely , the control group outcomes deteriorated . CONCLUSION An evidence based protocol for rehabilitation within the RDC lead to improved social outcomes and recovery for persons suffering from schizophrenia OBJECTIVE Acute psychiatric day care has been proposed as an alternative to conventional inpatient care , yet the evidence of its effectiveness is inconsistent and based only on single-site studies in 3 countries . The aim of this multicenter r and omized controlled trial was to establish the effectiveness of acute day hospital care in a large sample across a range of mental health care systems . METHOD The trial was conducted from December 2000 to September 2003 in 5 European countries , with a sample of 1117 voluntarily admitted patients . Immediately before or very shortly after admission to the participating psychiatric facilities , patients were r and omly allocated to treatment in a day hospital or an inpatient ward . Psychopathology , treatment satisfaction , subjective quality of life , and social disabilities were assessed at admission , at discharge , and 3 and 12 months after discharge . An intention-to-treat analysis was conducted using fixed-effects linear models with structured error covariance matrices and covariates . RESULTS Day hospital care was as effective as conventional inpatient care with respect to psychopathologic symptoms , treatment satisfaction , and quality of life . It was more effective on social functioning at discharge and at the 3- and 12-month follow-up assessment s. CONCLUSION This study , which has more than doubled the existing evidence base , has shown that day hospital care is as effective on clinical outcomes as conventional inpatient care and more effective on social outcomes . CLINICAL TRIALS REGISTRATION Clinical Trials.gov identifier NCT00153959 Internalized stigma is a complicating feature in the treatment of schizophrenia spectrum disorders and considerably hinders the recovery process . The empowerment and recovery-oriented program of our day clinic might contribute to a reduction in internalized stigma . The aim of the study was to explore the influence of this day clinic program on internalized stigma and other subjectively important outcome measures such as quality of life and psychopathology . Data from two groups of patients had been collected twice , at baseline and after 5 weeks . The experimental group attended the day clinic treatment ( N=40 ) and the control group waited for the day clinic treatment ( N=40 ) . The following significant differences between the two groups were found : Patients in day clinic treatment showed a reduction in internalized stigma while the control group showed a minimal increase ( Cohen 's d=0.446 ) . The experimental group as compared with the control group also showed a greater improvement in the quality of life domain psychological
Output:
| Psychiatric day clinics act as a link between inpatient and outpatient treatment in community mental healthcare . |
MS212460 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: PURPOSE In metastatic colorectal cancer , phase III studies have demonstrated the superiority of fluorouracil ( FU ) with leucovorin ( LV ) in combination with irinotecan or oxaliplatin over FU + LV alone . This phase III study investigated two sequences : folinic acid , FU , and irinotecan ( FOLFIRI ) followed by folinic acid , FU , and oxaliplatin ( FOLFOX6 ; arm A ) , and FOLFOX6 followed by FOLFIRI ( arm B ) . PATIENTS AND METHODS Previously untreated patients with assessable disease were r and omly assigned to receive a 2-hour infusion of l-LV 200 mg/m(2 ) or dl-LV 400 mg/m(2 ) followed by a FU bolus 400 mg/m(2 ) and 46-hour infusion 2,400 to 3,000 mg/m(2 ) every 46 hours every 2 weeks , either with irinotecan 180 mg/m(2 ) or with oxaliplatin 100 mg/m(2 ) as a 2-hour infusion on day 1 . At progression , irinotecan was replaced by oxaliplatin ( arm A ) , or oxaliplatin by irinotecan ( arm B ) . RESULT Median survival was 21.5 months in 109 patients allocated to FOLFIRI then FOLFOX6 versus 20.6 months in 111 patients allocated to FOLFOX6 then FOLFIRI ( P = .99 ) . Median second progression-free survival ( PFS ) was 14.2 months in arm A versus 10.9 in arm B ( P = .64 ) . In first-line therapy , FOLFIRI achieved 56 % response rate ( RR ) and 8.5 months median PFS , versus FOLFOX6 which achieved 54 % RR and 8.0 months median PFS ( P = .26 ) . Second-line FOLFIRI achieved 4 % RR and 2.5 months median PFS , versus FOLFOX6 which achieved 15 % RR and 4.2 months PFS . In first-line therapy , National Cancer Institute Common Toxicity Criteria grade 3/4 mucositis , nausea/vomiting , and grade 2 alopecia were more frequent with FOLFIRI , and grade 3/4 neutropenia and neurosensory toxicity were more frequent with FOLFOX6 . CONCLUSION Both sequences achieved a prolonged survival and similar efficacy . The toxicity profiles were different BACKGROUND Polychemotherapy and biological drugs have increased therapeutic options and outcomes of advanced colorectal cancer ( CRC ) . We examined the relation between progression-free survival ( PFS ) , post-progression survival ( PPS ) and overall survival ( OS ) in trials of modern ( oxaliplatin- and irinotecan-based ) chemotherapy alone or with targeted therapies for advanced CRC . We also evaluated surrogacy of PFS and OS . PATIENTS AND METHODS A PubMed search identified 34 r and omized trials . We split the OS , PFS and PPS and evaluated the correlation between OS and either PFS or PPS . RESULTS The median PPS and PFS were 10.75 and 8.4 months , respectively . For all trials , PPS was strongly associated with OS [ regression coefficient (R2)=0.8 ; Spearman 's rank correlation coefficient (r)=0.88 ] , whereas PFS was moderately associated with OS (R2)=0.43 ; r=0.64 ) . In trials with targeted therapies , the correlation of PPS with OS was 0.88 . However , across all trials , correlation between differences in median PFS ( ΔPFS ) and median OS ( ΔOS ) is 0.59 ( P=0.0007 ) , confirming PFS/OS surrogacy . CONCLUSION Our findings indicate that in recent first-line , phase III , trials , OS becomes more associated with PPS than PFS . However , improvements in PFS are strongly associated with improvements in OS . In this setting so , PFS may be an appropriate surrogate for OS AIM To evaluate the combination of bevacizumab with infusional 5-fluorouracil ( 5-FU ) , leucovorin ( LV ) and irinotecan ( FOLFIRI ) in patients with advanced colorectal cancer ( CRC ) pretreated with combination regimens including irinotecan and oxaliplatin . METHODS Fourteen patients ( median age 56 years ) with advanced CRC , all having progressed after oxaliplatin- and irinotecan-based combination chemotherapy , were enrolled in this study . Patients were treated with 2 h infusion of irinotecan 150 mg/m2 on d 1 , plus bevacizumab 5 mg/kg iv infusion for 90 min on d 2 , and iv injection of LV 20 mg/m2 followed by a bolus of 5-FU 400 mg/m2 and then 22 h continuous infusion of 600 mg/m2 given on two consecutive days every 14 d. RESULTS The median number of cycles of chemotherapy was six ( range 3 - 12 ) . The response rate was 28.5 % , one patient had a complete response , and three patients had a partial response . Eight patients had stable disease . The median time to progression was 3.9 mo ( 95 % CI 2.0 - 8.7 ) , and the median overall survival was 10.9 mo ( 95 % CI 9.6 - 12.1 ) . Grade 3/4 neutropenia occurred in five patients , and two of these developed neutropenic fever . Grade 3 hematuria and hematochezia occurred in one . Grade 2 proteinuria occurred in two patients . However , hypertension , bowel perforation or thromboembolic events did not occur in a total of 90 cycles . CONCLUSION Bevacizumab with FOLFIRI is well tolerated and a feasible treatment in patients with heavily treated advanced CRC BACKGROUND The optimum use of cytotoxic drugs for advanced colorectal cancer has not been defined . Our aim was to investigate whether combination treatment is better than the sequential administration of the same drugs in patients with advanced colorectal cancer . METHODS In this open-label , r and omised , phase 3 trial , we r and omly assigned patients ( 1:1 ratio ) with advanced , measurable , non-resectable colorectal cancer and WHO performance status 0 - 2 to receive either first-line treatment with bolus ( 400 mg/m(2 ) ) and infusional ( 2400 mg/m(2 ) ) fluorouracil plus leucovorin ( 400 mg/m(2 ) ) ( simplified LV5FU2 regimen ) , second-line LV5FU2 plus oxaliplatin ( 100 mg/m(2 ) ) ( FOLFOX6 ) , and third-line LV5FU2 plus irinotecan ( 180 mg/m(2 ) ) ( FOLFIRI ) or first-line FOLFOX6 and second-line FOLFIRI . Chemotherapy was administered every 2 weeks . R and omisation was done central ly using minimisation ( minimisation factors were WHO performance status , previous adjuvant chemotherapy , number of disease sites , and centre ) . The primary endpoint was progression-free survival after two lines of treatment . Analyses were by intention-to-treat . This trial is registered at Clinical Trials.gov , NCT00126256 . FINDINGS 205 patients were r and omly assigned to the sequential group and 205 to the combination group . 161 ( 79 % ) patients in the sequential group and 161 ( 79 % ) in the combination group died during the study . Median progression-free survival after two lines was 10·5 months ( 95 % CI 9·6 - 11·5 ) in the sequential group and 10·3 months ( 9·0 - 11·9 ) in the combination group ( hazard ratio 0·95 , 95 % CI 0·77 - 1·16 ; p=0·61 ) . All six deaths caused by toxic effects of treatment occurred in the combination group . During first-line chemotherapy , significantly fewer severe ( grade 3 - 4 ) haematological adverse events ( 12 events in 203 patients in sequential group vs 83 events in 203 patients in combination group ; p<0·0001 ) and non-haematological adverse events ( 26 events vs 186 events ; p<0·0001 ) occurred in the sequential group than in the combination group . INTERPRETATION Upfront combination chemotherapy is more toxic and is not more effective than the sequential use of the same cytotoxic drugs in patients with advanced , non-resectable colorectal cancer . FUNDING Sanofi-Aventis France
Output:
| FOLFIRI-B is a reasonable and effective option for stage IV CRC pretreated with oxaliplatin and not exposed to B during first-line treatment .
Its activity seems better than historical FOLFIRI-based second-line trials |
MS212461 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Control of body weight by balancing energy intake and energy expenditure is of major importance for the prevention of type 2 diabetes , but the role of specific dietary factors in the etiology of type 2 diabetes is less well established . We evaluated intakes of whole grain , bran , and germ in relation to risk of type 2 diabetes in prospect i ve cohort studies . Methods and Findings We followed 161,737 US women of the Nurses ' Health Studies ( NHSs ) I and II , without history of diabetes , cardiovascular disease , or cancer at baseline . The age at baseline was 37–65 y for NHSI and 26–46 y for NHSII . Dietary intakes and potential confounders were assessed with regularly administered question naires . We documented 6,486 cases of type 2 diabetes during 12–18 y of follow-up . Other prospect i ve cohort studies on whole grain intake and risk of type 2 diabetes were identified in search es of MEDLINE and EMBASE up to January 2007 , and data were independently extracted by two review ers . The median whole grain intake in the lowest and highest quintile of intake was , respectively , 3.7 and 31.2 g/d for NHSI and 6.2 and 39.9 g/d for NHSII . After adjustment for potential confounders , the relative risks ( RRs ) for the highest as compared with the lowest quintile of whole grain intake was 0.63 ( 95 % confidence interval [ CI ] 0.57–0.69 ) for NHSI and 0.68 ( 95 % CI 0.57–0.81 ) for NHSII ( both : p-value , test for trend < 0.001 ) . After further adjustment for body mass index ( BMI ) , these RRs were 0.75 ( 95 % CI 0.68–0.83 ; p-value , test for trend < 0.001 ) and 0.86 ( 95 % CI 0.72–1.02 ; p-value , test for trend 0.03 ) respectively . Associations for bran intake were similar to those for total whole grain intake , whereas no significant association was observed for germ intake after adjustment for bran . Based on pooled data for six cohort studies including 286,125 participants and 10,944 cases of type 2 diabetes , a two-serving-per-day increment in whole grain consumption was associated with a 21 % ( 95 % CI 13%–28 % ) decrease in risk of type 2 diabetes after adjustment for potential confounders and BMI . Conclusions Whole grain intake is inversely associated with risk of type 2 diabetes , and this association is stronger for bran than for germ . Findings from prospect i ve cohort studies consistently support increasing whole grain consumption for the prevention of type 2 diabetes BACKGROUND Certain dietary components may play a role in the prevention of type 2 diabetes . OBJECTIVE We examined prospect ively the associations between whole- and refined-grain intake and the risk of type 2 diabetes in a large cohort of men . DESIGN Men from the Health Professionals Follow-up Study without a history of diabetes or cardiovascular disease in 1986 ( n = 42898 ) were followed for < /=12 y. Intakes of whole and refined grains , measured every 4 y by use of food-frequency question naires , were used to predict subsequent type 2 diabetes risk through multivariate analysis . RESULTS We ascertained 1197 cases of incident type 2 diabetes . After adjustment for age ; physical activity ; cigarette smoking ; alcohol consumption ; family history of diabetes ; and fruit , vegetable , and energy intakes , the relative risk of type 2 diabetes was 0.58 ( 95 % CI : 0.47 , 0.70 ; P for trend < 0.0001 ) comparing the highest with the lowest quintile of whole-grain intake . The association was moderately attenuated when additionally adjusted for body mass index ( relative risk : 0.70 ; 95 % CI : 0.57 , 0.85 ; P for trend = 0.0006 ) . Intake of refined grains was not significantly associated with risk of type 2 diabetes . After further adjustment for magnesium intake , cereal fiber intake , and glycemic load , the association between whole grains and type 2 diabetes was attenuated and the trend no longer significant . CONCLUSIONS In men , a diet high in whole grains is associated with a reduced risk of type 2 diabetes in men that may be mediated by cereal fiber . Efforts should be made to replace refined-grain with whole-grain foods OBJECTIVE To examine associations between type 2 diabetes and fiber , glycemic load ( GL ) , dietary glycemic index ( GI ) , and fiber-rich foods . RESEARCH DESIGN AND METHODS This was a prospect i ve study of 36,787 men and women aged 40 - 69 years without diabetes . For all self-reported cases of diabetes at 4-year follow-up , confirmation of diagnosis was sought from medical practitioners . Case subjects were those who reported diabetes at follow-up and for whom there was no evidence that they did not have type 2 diabetes . Data were analyzed with logistic regression , adjusting for country of birth , physical activity , family history of diabetes , alcohol and energy intake , education , 5-year weight change , sex , and age . RESULTS Follow-up was completed by 31,641 ( 86 % ) participants , and 365 cases were identified . The odds ratio ( OR ) for the highest quartile of white bread intake compared with the lowest was 1.37 ( 95 % CI 1.04 - 1.81 ; P for trend = 0.001 ) . Intakes of carbohydrate ( OR per 200 g/day 0.58 , 0.36 - 0.95 ) , sugars ( OR per 100 g/day 0.61 , 0.47 - 0.79 ) , and magnesium ( OR per 500 mg/day 0.62 , 0.43 - 0.90 ) were inversely associated with incidence of diabetes , whereas intake of starch ( OR per 100 g/day 1.47 , 1.06 - 2.05 ) and dietary GI ( OR per 10 units 1.32 , 1.05 - 1.66 ) were positively associated with diabetes . These relationships were attenuated after adjustment for BMI and waist-to-hip ratio . CONCLUSIONS Reducing dietary GI while maintaining a high carbohydrate intake may reduce the risk of type 2 diabetes . One way to achieve this would be to substitute white bread with low-GI breads PURPOSE Whole grains may offer protection from diabetes by decreasing energy intake , preventing weight gain , and direct effects on insulin resistance . This study examined associations of whole and refined grains with incident type 2 diabetes ( T2D ) ascertained by self-reported medication use in a cohort of postmenopausal women . METHODS We included 72,215 women free of diabetes at baseline from the Women 's Health Initiative Observational Study . Whole grain consumption was categorized as 0 , less than 0.5 , 0.5 to 1.0 , 1.0 to less than 1.5 , 1.5 to less than 2.0 , and 2.0 or more servings per day . Proportional hazards regression was performed to estimate hazard ratios ( HR ) and 95 % confidence intervals adjusting for potential confounders . RESULTS There were 3465 cases of incident T2D over median follow-up of 7.9 years . Adjusted for age and energy intake per day , successively increasing categories of whole grain consumption were associated with statistically significant reduced risk of incident T2D ( HRs , 1.00 , 0.83 , 0.73 , 0.69 , 0.61 , and 0.57 ; P for trend < 0.0001 ) . Results were attenuated after adjustment for confounders and other dietary components . The reduction in risk of T2D was greater among nonsmokers and those who maintained their weight within 5 pounds with higher consumption of whole grains than smokers and women who gained more weight . CONCLUSIONS This large , prospect i ve study found an inverse dose-response relationship between whole grain consumption and incident T2D in postmenopausal women Seven men with well-controlled , noninsulin-dependent ( type 2 ) diabetes ingested on two different mornings , in r and om order , meals with or without a 5.0-g sodium alginate supplement ( algae-isolate , 75 % soluble fiber ) . The meals contained similar amounts of digestible carbohydrates , fat and protein . The gastric emptying rate of the meal containing sodium alginate , measured by detection of 51Cr mixed into the meals , was significantly slower than that of the fiber-free meal . Sodium alginate also induced significantly lower postpr and ial rises in blood glucose , serum insulin and plasma C-peptide . The diminished glucose response after the addition of sodium alginate could be correlated to the delayed gastric emptying rate induced by the fiber ( rs = 0.92 , P less than 0.01 ) BACKGROUND Dietary carbohydrates may influence the development of type 2 ( non-insulin-dependent ) diabetes , for example , through effects on blood glucose and insulin concentrations . OBJECTIVE We examined the relations of baseline intake of carbohydrates , dietary fiber , dietary magnesium , and carbohydrate-rich foods and the glycemic index with incidence of diabetes . DESIGN This was a prospect i ve cohort study of 35988 older Iowa women initially free of diabetes . During 6 y of follow-up , 1141 incident cases of diabetes were reported . RESULTS Total grain , whole-grain , total dietary fiber , cereal fiber , and dietary magnesium intakes showed strong inverse associations with incidence of diabetes after adjustment for potential nondietary confounding variables . Multivariate-adjusted relative risks of diabetes were 1.0 , 0.99 , 0.98 , 0.92 , and 0.79 ( P for trend : 0.0089 ) across quintiles of whole-grain intake ; 1.0 , 1.09 , 1.00 , 0.94 , and 0.78 ( P for trend : 0.005 ) across quintiles of total dietary fiber intake ; and 1.0 , 0.81 , 0.82 , 0.81 , and 0.67 ( P for trend : 0.0003 ) across quintiles of dietary magnesium intake . Intakes of total carbohydrates , refined grains , fruit and vegetables , and soluble fiber and the glycemic index were unrelated to diabetes risk . CONCLUSION These data support a protective role for grains ( particularly whole grains ) , cereal fiber , and dietary magnesium in the development of diabetes in older women BACKGROUND Rye bread has a beneficial effect on the postpr and ial insulin response in healthy subjects . The role of rye fiber in insulin and glucose metabolism is not known . OBJECTIVE The aim of the study was to determine the effect of the content of rye fiber in rye breads on postpr and ial insulin and glucose responses . DESIGN Nineteen healthy postmenopausal women aged 61 + /- 1 y , with a body mass index ( in kg/m(2 ) ) of 26.0 + /- 0.6 , and with normal glucose tolerance participated in the study . The test products were refined wheat bread ( control ) , endosperm rye bread , traditional rye bread , and high-fiber rye bread ; each bread provided 50 g available carbohydrate and was served with breakfast . Plasma glucose , insulin , glucose-dependent insulinotropic polypeptide , glucagon-like peptide 1 , and serum C-peptide were measured in fasting and 8 postpr and ial blood sample s. In vitro starch hydrolysis and the microscopic structure of the breads were also determined . RESULTS Postpr and ial insulin , glucose-dependent insulinotropic polypeptide , and C-peptide responses to the rye breads were significantly lower than the response to the control ; no significant differences in insulin and C-peptide responses to the rye breads were found . Glucose and glucagon-like peptide 1 responses to the rye breads were not significantly different from those to the control , except at 150 and 180 min . In vitro starch hydrolysis was slower in all rye breads than in the control , and the structure of continuous matrix and starch granules differed between the rye and control breads . CONCLUSION Total fiber content does not explain the lower postpr and ial insulin response to rye bread than to wheat bread , but structural differences between rye and wheat breads might BACKGROUND Epidemiologic studies that directly examine changes in whole-grain consumption in relation to weight gain are sparse , and characterization of this association has been obscured by method ologic inconsistencies in the
Output:
| Our meta- analysis suggests that a high whole grain intake , but not refined grains , is associated with reduced type 2 diabetes risk .
Our results support public health recommendations to replace refined grains with whole grains and suggest that at least two servings of whole grains per day should be consumed to reduce type 2 diabetes risk |
MS212462 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Quality of life may be considerably reduced in patients who are suffering from chronic lower limb venous insufficiency , although existing generic quality of life instruments ( NHP , SF-36 or SIP ) can not completely identify their specific complaints . The Chronic Venous Insufficiency Question naire ( CIVIQ ) has been developed by iterative process . First , a pilot group of 20 patients was used to identify a number of important features of quality of life affected by venous insufficiency , other than physical symptoms of discomfort . A second study involving 2,001 subjects was used to reduce the number of items . Subjects were asked to score both the severity of their problems and the importance they attributed to each problem on a 5-point Likert scale . The importance items found in patients with venous insufficiency were subjected to factorial analyses ( PCA , PAF ) . The final version is a 20-item self-administered question naire which explores four dimensions : psychological , physical and social functioning and pain . Internal consistency of the question naire was vali date d for each dimension ( Cronbach 's alpha > 0.820 for three out of four factors ) . Reproducibility was confirmed in a 60 patient test-retest study . Pearson 's correlation coefficients for both the four dimension subscales and for the global score at 2-week intervals were greater than 0.940 . Finally , the question naire was tested in a r and omized clinical trial of 934 patients in order to assess responsiveness and the convergent validity of the instrument , together with the patient 's own quality of life . This study demonstrated that convergence was valid : Pearson 's correlation coefficients between clinical score differences and quality of life score differences were small ( from 0.199–0.564 ) but were statistically different from 0 ( p<0.001 ) . St and ardized response mean ( SRM ) and effect size ( ES ) were calculated to assess sensitivity to change . SRM and ES both demonstrated considerble responsiveness to change ( > 0.80 ) . Reliability , face , content , construct validity and responsiveness were also determined for this specific quality of life question naire relating to venous insufficiency . Results suggest that this question naire may be used with confidence to assess quality of life in clinical trials on chronic venous insufficiency STUDY OBJECTIVE : To determine the prevalence of varicose veins and chronic venous insufficiency ( CVI ) in the general population . DESIGN : Cross sectional survey . SETTING : City of Edinburgh . PARTICIPANTS : Men and women aged 18 - 64 years selected r and omly from age-sex registers of 12 general practice s. MAIN RESULTS : In 1566 subjects examined , the age adjusted prevalence of trunk varices was 40 % in men and 32 % in women ( p < or = 0.01 ) . This sex difference was mostly a result of higher prevalence of mild trunk varices in men . More than 80 % of all subjects had mild hyphenweb and reticular varices . The age adjusted prevalence of CVI was 9 % in men and 7 % in women ( p < or = 0.05 ) . The prevalence of all categories of varices and of CVI increased with age ( p < or = 0.001 ) . No relation was found with social class . CONCLUSIONS : Approximately one third of men and women aged 18 - 64 years had trunk varices . In contrast with the findings in most previous studies , mainly conducted in the 1960s and 1970s , chronic venous insufficiency and mild varicose veins were more common in men than women . No evidence of bias in the study was found to account for this sex difference . Changes in lifestyle or other factors might be contributing to an alteration in the epidemiology of venous disease AIM Epidemiological data show that st and ard compression therapy for leg ulceration in chronic venous insufficiency ( CVI ) often fails to effectively improve patients ' condition . This study assesses the contribution of Daflon 500 mg added to conventional therapy in the healing of hypostatic ulcers of CVI patients . METHODS Patients of about 65 years were included , with ulcers > or = 2 and > or = 10 cm diameter on 1 or 2 limbs , Doppler ankle/arm pressure index > 0.9 , and no recent history of skin graft . Controls ( n=68 ) remained on compression alone while the tested group ( n=82 ) also received Daflon 500 mg 2 tablets/day during 6 months . Treatment could be stopped as soon as the reference ulcer appeared fully healed . Primary endpoints were the rate of healed ulcers and the time to complete healing assessed by planimetry/photography and clinical examination . Variations of the ulcer surface , appearance of the skin , and clinical symptoms of CVI were the secondary criteria . RESULTS Only 7 % of Daflon 500 mg patients necessitated the full 6 month therapy . Whatever the lesion size , from W8 significantly more healed ulcers were observed under Daflon 500 mg ( p=0.004 ) , and the ulcer surface was more reduced ( p=0.012 ) . For large ulcers , the rate of healing was approximately 2-fold higher with Daflon 500 mg , and the percentage of ulcers healed before W24 was significantly higher ( p=0.008 ) . Heavy leg sensation was significantly improved by Daflon 500 mg from W4 ( p < 0.05 ) . No treatment-related side effects were reported and the acceptability was considered excellent by 85 % of Daflon 500 mg patients . CONCLUSION Six months of Daflon 500 mg in addition to compression significantly improve some clinical symptoms and accelerate the healing process in patients with ulcerous complications of CVI , with a good acceptability AIM The Vein Consult Program is an international , observational , prospect i ve survey aim ing to collect global epidemiological data on chronic venous disorders ( CVD ) based on the CEAP classification , and to identify CVD management worldwide . The survey was organized within the framework of ordinary consultations , with general practitioners ( GPs ) properly trained on the use of the CEAP classification . METHODS Screening for CVD was to be performed by enrolling in the survey all consecutive out patients > 18 years whatever the reason for consultation , to record patient 's data and classify them according to the CEAP , from the stage C0s to C6 . The program enrolled 6232 GPs 91545 subjects were analysed . Their mean age was 50.6±16.9 years , younger patients being in the Middle East and older ones in Europe , and the proportion of women was higher than that of men . RESULTS The worldwide prevalence of CVD was 83.6 % : 63.9 % of the subjects ranging C1 to C6 , and 19.7 % being C0s subjects . C0s patients were more frequently men whatever the age and the geographical zone . C1-C3 appeared to be more frequent among women whatever the country but the rate of severe stages ( C4-C6 ) did not differ between men and women . GPs consider CVD subjects as patients eligible to specialist referral beginning from C2 but some geographical disparities were observed . CONCLUSION The VCP survey provides reliable results on CVD global epidemiology and shows that CVD affects a significant part of the population s worldwide , underlining the importance of adequate screening for CVD and training of both GPs and specialist physicians The objective of this study was to evaluate the efficacy of Daflon ® 500 mg ( Dios ) * in venous ulcers . A multicenter , double-blind , r and omized , controlled versus placebo ( Plac ) trial was conducted , with stratification according to the size of ulcer ( ≤ 10 cm and > 10 cm ) . The protocol called for a two-month treatment with Dios ( one tablet = 450 mg micronized purified Diosmin ) or a placebo , two tablets/day , in addition to compression therapy . Evaluations were performed every fifteen days , from DO to D60 . The primary endpoint , in accordance with Alex and er House group requirements were : percentage of patients with complete ulcer healing , ie , comparison between Dios and Plac group at D60 , and comparison of survival curves in each group between DO and D60 ( log rank test ) . Secondary endpoints included ulcer surface area assessed by computerized plani metric measurements , qualitative evaluation of ulcers , and symptoms . The patients were 105 men and women ranging in age from eighteen to eighty-five years , with st and ard compression stocking , who were undergoing st and ardized local care of ulcer and had no significant arterial disease ( ankle/arm systolic pressure index > 0.8 ) . Fifty-three patients received Dios , and 52 received Plac . The 2 groups were well matched for age ( m ±1 SD = seventy-one ±eleven years ) , gender , ulcer size , and associated disorders . Among patients with ulcer size ≤ 10 cm ( Dios = 44 , Plac = 47 ) a significantly larger number of patients had a complete ulcer healing at two months in the Dios group ( n = 14 ) in comparison with the Plac group ( n = 6 ) ( 32 % vs 13 % , P = 0.028 ) with a signifi cantly shorter time duration of healing ( P = 0.037 ) . No difference was shown for the secondary criteria , except for sensation of heavy legs ( P = 0.039 ) and a less atonic aspect of ulcer ( P = 0.030 ) in favor of Dios . Among the 14 patients with ulcer size > 10 cm ( Dios = 9 , Plac = 5 ) , subjected to a descriptive analysis only , no ulcer healed . This study showed that a two-month course of Daflon 500 mg at a daily dose of two tablets , in addition to conventional treatment , is of benefit in patients with venous ulcer ≤ 10 cm by accelerating complete healing OBJECTIVE to evaluate the efficacy of a micronised purified flavonoid fraction ( MPFF ) in the treatment of chronic venous disease ( CVD ) . DESIGN prospect i ve double blind , r and omised , control study . PATIENTS AND METHODS one hundred and one patients with symptomatic CVD were r and omly allocated to treatment for 60 days with either MPFF ( 51 patients ) or placebo ( 50 patients ) 500 mg twice daily . There were 28 men and 73 women , aged 22 - 65 years ( mean age 48 years ) . No difference regarding age , gender , clinical class or duration of symptoms was recorded between the treatment and placebo groups . A global score for evaluation of symptoms was used . Patients were investigated with plethysmography ( foot-volumetry ) and duplex-ultrasonography before and after the treatment period . For statistical comparison Cochran-Mantel-Haenszel test , two-sided Student t-test and covariance analysis were used and p<0.05 was regarded significant . RESULTS improvement of the global score of symptoms was reported by 21 patients in the MPFF group and by 16 in the placebo group ( N.S. ) . For the whole groups , no significant differences were recorded before and after treatment regarding foot-volumetric or ultrasonographic parameters . On the other h and , in patients with edema ( 20 in the MPFF group , 23 in the placebo group ) ultrasonographic reflux time was significantly reduced for those in the treatment group ( p=0.03 ) . This finding did not correlate to clinical symptoms . CONCLUSION in this study , MPFF did not change the symptoms of CVD , except night cramps . A secondary finding was reduced reflux times in patients with oedema , although no ultrasonographic or foot-volumetric parameters changed significantly for the whole group . The role of MPFF in treatment of patients with CVD needs to be further analysed in a large population Chronic venous insufficiency ( CVI ) of the lower limbs is a complex and fluctuating disease by its pathogenic mechanisms and its clinical symptoms . Although symptoms are subjective , they affect the quality of life and socio-professional activity of many patients . This is why convincing demonstration of therapeutic activity of a venotropic drug should be carried out according to strict methodology . Only r and omized double-blind controlled trials versus placebo ( no reference drugs being available ) could demonstrate the activity on condition that they are set up in a protocol , the statistical design of which , is adapted and defined " a priori " . Inclusion , non inclusion and judgement criteria must be rigorous , taking into account many exogenous and endogenous factors which could have influence on the severity or the change in CVI and on the comparability of groups at the beginning and at the end of the study . Thus , the main risk factors of CVI ( heredity , obesity , obstetrical and gynecological history , estroprogestogen treatment , profession , environment , etc . ) and the season when the patient is recruited should be taken into account . With respect to all these restraints on methodology , the venotrotopic activity of a flavonoid Daflon 500 mg ( 2 tablets daily ) was demonstrated in 200 patients ( 174 women , 26 men ) with organic CVI ( n = 83 ) or functional CVI ( n = 117 ) treated for two months in two double-blind r and omized trials versus placebo . The venotropic activity of Daflon 500 mg , was shown by a significant reduction of CVI signs and symptoms , whether organic or functional , and a significant improvement in venous hemodynamics according to plethysmographic parameters . Good acceptability was observed after medium and long term trials OBJECTIVE To assess the efficacy of a micronized purified flavonoid fraction ( Daflon 500 mg = Dios ) in venous leg ulcer healing , in addition to compression therapy and st and ardized local care . DESIGN Double-blind , multicentre , r and omized , parallel groups , controlled versus placebo trial ; strat
Output:
| Conclusion In summary , the general level of evidence supports the recommendation that the use of medical therapy with Micronized Purified Flavonoid Fraction has beneficial outcomes without serious adverse events .
In the United States , diosmiplex is the only available prescription formulation of Micronized Purified Flavonoid Fraction . |
MS212463 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES : Several studies have evaluated whether evidence -based medicine ( EBM ) training courses can improve skills such as literature search ing and critical appraisal but to date , few data exist on whether teaching EBM skills and providing evidence -based re sources result in change in behavior or clinical outcomes . This study was conducted to evaluate whether a multifaceted EBM intervention consisting of teaching EBM skills and provision of electronic evidence re sources changed clinical practice . DESIGN : Before/after study . SETTING : The medical inpatient units at a district general hospital . PARTICIPANTS : Thirty-five attending physicians and 12 medicine residents . INTERVENTION : A multicomponent EBM intervention was provided including an EBM training course of seven 1-hour sessions , an EBM syllabus and textbook , and provision of evidence -based re sources on the hospital network . MEASUREMENTS AND MAIN RESULTS : The primary outcome of the study was the quality of evidence in support of therapies initiated for the primary diagnoses in 483 consecutive patients admitted during the month before and the month after the intervention . Patients admitted after implementation of the EBM intervention were significantly more likely to receive therapies proven to be beneficial in r and omized controlled trials ( 62 % vs 49 % ; P=.016 ) . Of these trial-proven therapies , those offered after the EBM intervention were significantly more likely to be based on high- quality r and omized controlled trials ( 95 % vs 87 % ; P=.023 ) . CONCLUSIONS : A multifaceted intervention design ed to teach and support EBM significantly improved evidence -based practice patterns in a district general hospital This critical review examines the efficacy of communication interventions for improving communication outcomes in adolescents with acquired brain injury . Five articles were included in this review . Studies included four Level 1 design s ( i.e. , one r and omized controlled trial ( RCT ) , one single subject crossover design , one single subject multiple baseline design , one single subject design ) , and one Level 3 design ( i.e. , single group preposttest design ) . Overall , the results of this review revealed suggestive evidence that communication interventions are effective at improving communication outcomes for adolescents with acquired brain injury . Clinical implication s and future research recommendations are also discussed Objective To determine whether fellowship training in critical care medicine with critical appraisal exercises improves the ability and confidence of fellows to evaluate the medical literature . Design Prospect i ve , interventional pilot study . Setting Multidisciplinary critical care medicine training program at a large university hospital . InterventionFellows were given three didactic sessions covering study design , analysis , and critical appraisal techniques . During the course of the year , each fellow was required to review one article from the literature and present a critique of this article to the group and faculty ( Journal Club ) . Fellows were guided in the preparation of this presentation by one of the critical care medicine faculty . Finally , a written analysis and critique of the article was performed by each fellow . Measurements and Main Results A test was given to each fellow at the beginning and end of the academic year . This test consisted of two pairs of articles on therapy for acute lung injury . For the pretest , each fellow was assigned , at r and om , one pair of articles . Fellows were given 1 hr to review both articles and to fill out a six-point test to assess their ability and confidence to appraise each article . At the end of the year , each fellow was tested on the opposite pair , the tests were grade d in a blinded fashion and the results of each test were compared . Six fellows completed both pre- and posttests . These paired results were analyzed separately , whereas results for another six fellows were conducted as an unpaired analysis . Mean scores increased both for the paired analysis ( 4.1 ± 0.7 vs. 5.1 ± 0.5;p = .015 ) and for the unpaired analysis ( 4.3 ± 0.6 vs. 5.0 ± 0.5;p = .012 ) . Self-reported confidence in critical appraisal also increased ( 2.5 ± 0.5 vs. 3.9 ± 0.7;p = .004 and 2.6 ± 0.5 vs. 3.9 ± 0.6;p < .001 , respectively ) . Conclusion Critical appraisal exercises used in the training of critical care medicine fellows appear to improve both ability and confidence to appraise relevant medical literature Background Attitudes and barriers to implementing EBM have been examined extensively , but scant evidence exists regarding the impact of EBM teaching on primary care physicians ’ point of care behavior . Objective Gaining insight into behavioral and attitudinal changes of facilitators and participants during a multifaceted EBM educational intervention . Design , setting , and participants A qualitative study on primary care physicians and facilitators from a large HMO selected from the intervention arm of a parallel controlled trial using purpose ful sampling . We conducted focus groups with 13 facilitators and 17 physicians and semi-structured interviews with 10 facilitators and 11 physicians . Results Both facilitators and participants believed EBM enhanced the quality of their practice . The intervention affected attitudes and knowledge , but had little impact on physicians ’ ability to utilize pre-appraised re sources at the point of care . Using EBM re sources during consultation was perceived to be a complex task and impractical in a busy setting . Conversely , a positive impact on using medication data bases was noted . Medication data bases were perceived as easy to use during consultations in which the benefits outweighed the barriers . The intervention prompted physicians to write down clinical questions more frequently and to search for answers at home . Conclusions This study underlines the need not only to enhance EBM skills , but also to improve the ease of use of EBM re sources at the point of care . Tasks should be simplified by tailoring evidence -based information retrieval systems to the busy clinical schedule . Participants ’ recommendations to establish an HMO decision support service should be considered STUDY OBJECTIVES To compare the performance of an evidence -based medicine ( EBM ) approach and a traditional approach to teaching critical appraisal skills to emergency medicine residents . METHODS This was a prospect i ve , case-controlled trial of 32 emergency medicine residents ( 16 control and 16 intervention ) . Intervention residents were exposed to a monthly , 1-hour journal club using an EBM approach to critical appraisal over the course of 1 year . Control residents were exposed to a traditional , unstructured journal club , also monthly . Both groups were given a factitious article to evaluate in an essay format before and after the 12-month study period . The Wilcoxon rank sum test was used to compare mean improvement in test scores for each group . RESULTS The mean improvement in test scores was 1.80 for the control group and 1.53 for the intervention group ; these values were not significantly different ( P = .90 ) . The difference in mean change in test score between the 2 groups was.27 points . CONCLUSION Compared with a traditional approach , an EBM approach to teaching critical appraisal did not appear to improve the critical appraisal skills of emergency medicine residents . However , because of the small number of subjects studied , small differences in critical appraisal skill improvement can not be ruled out OBJECTIVE To investigate whether a limited teaching intervention , based on principles of adult education , could change residents ' literature reading attitudes , behaviors , and knowledge . DESIGN The educational intervention supplemented an ongoing bimonthly journal club . The effects on residents were studied prospect ively before and four months following the intervention . SETTING A community hospital internal medicine training program . PARTICIPANTS All 14 residents : six in the first year , and four each in the second and third years of training . INTERVENTION A one-hour seminar incorporating principles of adult education , including the use of multiple teaching modalities . The content was based on the critical literature reading guidelines published by the McMaster group . Reinforcement of learning objectives was achieved by learner participation , written assignments , active feedback , and follow-up in subsequent journal clubs . RESULTS Residents improved their performances on objective testing of critical appraisal knowledge by 60 % ( p = 0.02 ) . They reported improved ability to appraise original research articles critically ( p = 0.01 ) and reported spending more useful time reading . Unaffected were the total time spent reading journals , the reasons for reading them , and the perceived value of journals in " keeping up " with advances in medical knowledge . CONCLUSION Journal clubs are important to residents , and their effectiveness in teaching critical appraisal and promoting reading of the literature may be augmented by applying principles of adult education BACKGROUND We performed a prospect i ve controlled trial of a monthly journal club to determine if it would increase pediatric residents ' knowledge of clinical epidemiology and biostatistics . METHODS Intervention residents received two didactic sessions before the journal club started . Eight monthly journal club sessions followed . Pediatric residents at another institution served as controls . Intervention and control residents completed a pre- and post-test on clinical epidemiology and biostatistics . RESULTS Neither the intervention nor the control group showed a significant change in test scores over the 9-month period . CONCLUSION A more intensive and more structured approach is needed to effectively teach clinical epidemiology and biostatistics to residents Background A discipline which critically looks at the evidence for practice should itself be critically examined . Credible evidence for the effectiveness of training in evidence -based healthcare ( EBHC ) is essential . We attempted to summarise the current knowledge on evaluating the effectiveness of training in EBHC while identifying the gaps . Methods A working group of EBHC teachers developed a conceptual framework of key areas of EBHC teaching and practice in need of evidence mapped to appropriate methods and outcomes . A literature search was conducted to review the current state of research in these key areas . Studies of training interventions that evaluated effectiveness by considering learner , patient or health system outcomes in terms of knowledge , skills , attitude , judgement , competence , decision-making , patient satisfaction , quality of life , clinical indicators or cost were included . There was no language restriction . Results Of 55 articles review ed , 15 met the inclusion criteria : six systematic review s , three r and omised controlled trials and six before-after studies . We found weak indications that undergraduate training in EBHC improves knowledge but not skills , and that clinical ly integrated postgraduate teaching improves both knowledge and skills . Two r and omised controlled trials reported no impact on attitudes or behaviour . One before-after study found a positive impact on decision-making , while another suggested change in learners ' behaviour and improved patient outcome . We found no studies assessing the impact of EBHC training on patient satisfaction , health-related quality of life , cost or population -level indicators of health . Conclusions Literature evaluating the effectiveness of training in EBHC has focused on short-term acquisition of knowledge and skills . Evaluation design s were method ologically weak , controlled trials appeared inadequately powered and systematic review s could not provide conclusive evidence owing to weakness of study design An investigation was made as to whether studies have found journal clubs for physicians in training to be effective for improving patient . care , teaching critical appraisal skills , improving reading habits , increasing knowledge of clinical epidemiology and biostatistics , and increasing the use of medical literature in clinical practice . A literature search was undertaken using 10 data bases and retrieval systems and h and search es of journals , conference proceedings and personal files . The rigor of studies meeting the inclusion criteria was analyzed using a protocol based on methods established by the Cochrane Collaboration . One r and omized controlled trial found an improvement in knowledge of clinical epidemiology and biostaristics , reading habits , and the use of medical literature in practice , but no improvement in critical appraisal skills . Six less method ologically rigorous studies found possible improvement in critical appraisal skills . It is concluded that journal clubs may improve knowledge of clinical epidemiology and biostatistics , reading habits , and the use of medical literature in practice . A multi-center , r and omized controlled trial of journal clubs is needed to assess whether journal clubs improve critical appraisal skills This study sought to identify the attitudes of family practice residents toward journal clubs and the effect that preparing a journal club session has on the resident 's view of the medical literature . Residents from Valley Medical Center were prospect ively assessed over a three-year period . Residents selected the improvement of critical appraisal skills as the most important journal club goal . However , they reported that their journal club experiences did not improve their opinions of the journals selected . The results are discussed in the context of recent trends in journal clubs OBJECTIVE To determine the effectiveness of different types of interventions in improving health professional performance and health outcomes . DATA SOURCES MEDLINE , SCI SEARCH , CINAHL and the Research and Development Re source Base in CME were search ed for trials of educational interventions in the health care professions published between 1970 and 1993 inclusive . STUDY SELECTION Studies were selected if they provided objective measurements of health professional performance or health outcomes and employed r and om or quasi-r and om allocation methods in their study design s to assign individual subjects or groups . Interventions included such activities as conferences , outreach visits , the use of local opinion leaders , audit and feedback , and reminder systems . DATA EXTRACTION Details extracted from the studies included the study design ; the unit of allocation ( e.g. , patient , provider , practice , hospital ) ; the characteristics of the targeted health care professionals , educational interventions and patients ( when appropriate ) ; and the main outcome measure . DATA SYNTHESIS The inclusion criteria were met by 102 trials . Areas of behaviour change included general patient management , preventive services , prescribing practice s , treatment of specific conditions such as hypertension or diabetes , and diagnostic service or hospital utilization . Dissemination-only strategies , such as conferences or the mailing of unsolicited material s , demonstrated little or no changes in health professional behaviour or health outcome when used alone . More complex interventions , such as the use of outreach visits or local opinion leaders , ranged from ineffective to highly effective but were most often moderately effective ( result ing in reductions of 20 % to 50 % in the incidence of inappropriate performance ) . CONCLUSION There are no " magic bullets " for improving the quality of health care , but there are a wide range of interventions available that , if used appropriately , could lead to important improvements in professional practice and patient outcomes The journal club is
Output:
| The effectiveness of JCs in supporting evidence -based decision making is not clear . |
MS212464 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE Adjuvant chemotherapy for breast cancer can have adverse effects on cognition shortly after administration . Whether chemotherapy has any long-term effects on cognition is largely unknown , yet it becomes increasingly relevant because of the widespread use of chemotherapy for early-stage breast cancer and the improved survival . We investigated whether cyclophosphamide , methotrexate , and fluorouracil ( CMF ) chemotherapy for breast cancer is associated with worse cognitive performance more than 20 years after treatment . PATIENTS AND METHODS This case-cohort study compared the cognitive performance of patients with breast cancer who had a history of adjuvant CMF chemotherapy treatment ( six cycles ; average time since treatment , 21 years ; n = 196 ) to that of a population -based sample of women never diagnosed with cancer ( n = 1,509 ) . Participants were between 50 and 80 years of age . Exclusion criteria were ever use of adjuvant endocrine therapy , secondary malignancy , recurrence , and /or metastasis . RESULTS The women exposed to chemotherapy performed significantly worse than the reference group on cognitive tests of immediate ( P = .015 ) and delayed verbal memory ( P = .002 ) , processing speed ( P < .001 ) , executive functioning ( P = .013 ) , and psychomotor speed ( P = .001 ) . They experienced fewer symptoms of depression ( P < .001 ) , yet had significantly more memory complaints on two of three measures that could not be explained by cognitive test performance . CONCLUSION Survivors of breast cancer treated with adjuvant CMF chemotherapy more than 20 years ago perform worse , on average , than r and om population controls on neuropsychological tests . The pattern of cognitive problems is largely similar to that observed in patients shortly after cessation of chemotherapy . This study suggests that cognitive deficits following breast cancer diagnosis and subsequent CMF chemotherapy can be long lasting Background Cognitive problems in breast cancer patients are common after systemic treatment , particularly chemotherapy . An increasing number of fMRI studies show altered brain activation in breast cancer patients after treatment , suggestive of neurotoxicity . Previous prospect i ve fMRI studies administered a single cognitive task . The current study employed two task paradigms to evaluate whether treatment-induced changes depend on the probed cognitive domain . Methods Participants were breast cancer patients scheduled to receive systemic treatment ( anthracycline-based chemotherapy + /- endocrine treatment , n = 28 ) , or no systemic treatment ( n = 24 ) and no-cancer controls ( n = 31 ) . Assessment took place before adjuvant treatment and six months after chemotherapy , or at similar intervals . Blood oxygen level dependent ( BOLD ) activation and performance were measured during an executive functioning task and an episodic memory task . Group-by-time interactions were analyzed using a flexible factorial design . Results Task performance did not differ between patient groups and did not change over time . Breast cancer patients who received systemic treatment , however , showed increased parietal activation compared to baseline with increasing executive functioning task load compared to breast cancer patients who did not receive systemic treatment . This hyperactivation was accompanied by worse physical functioning , higher levels of fatigue and more cognitive complaints . In contrast , in breast cancer patients who did not receive systemic treatment , parietal activation normalized over time compared to the other two groups . Conclusions Parietal hyperactivation after systemic treatment in the context of stable levels of executive task performance is compatible with a compensatory processing account of hyperactivation or maintain adequate performance levels . This over-recruitment of brain regions depends on the probed cognitive domain and may represent a response to decreased neural integrity after systemic treatment . Overall these results suggest different neurobehavioral trajectories in breast cancer patients depending on treatment type Objective : To assess patterns of regional brain activation in response to varying working memory loads shortly after mild traumatic brain injury ( MTBI ) . Background : Many individuals complain of memory difficulty shortly after MTBI . Memory performance in these individuals can be normal despite these complaints . Methods : Brain activation patterns in response to a working memory task ( auditory n-back ) were assessed with functional MRI in 12 MTBI patients within 1 month of their injury and in 11 healthy control subjects . Results : Brain activation patterns differed between MTBI patients and control subjects in response to increasing working memory processing loads . Maximum intensity projections of statistical parametric maps in control subjects showed bifrontal and biparietal activation in response to a low processing load , with little additional increase in activation associated with the high load task . MTBI patients showed some activation during the low processing load task but significantly increased activation during the high load condition , particularly in the right parietal and right dorsolateral frontal regions . Task performance did not differ significantly between groups . Conclusion : MTBI patients differed from control subjects in activation pattern of working memory circuitry in response to different processing loads , despite similar task performance . This suggests that injury-related changes in ability to activate or to modulate working memory processing re sources may underlie some of the memory complaints after MTBI PURPOSE We previously evaluated fatigue , menopausal symptoms , and cognitive dysfunction in patients receiving adjuvant therapy for breast cancer and matched healthy women . Here we report assessment of these women 1 and 2 years later . PATIENTS AND METHODS Patients without relapse and controls were evaluated by the Functional Assessment of Cancer Treatment-General Quality of Life question naire , with subscales for fatigue and endocrine symptoms , and by the High Sensitivity Cognitive Screen . RESULTS There were 104 , 91 , and 83 patients and 102 , 81 , and 81 controls assessed at baseline and at 1 and 2 years , respectively . Median Functional Assessment of Cancer Treatment-Fatigue scores ( range , 0 to 52 ) for patients improved from 31 ( on chemotherapy ) to 43 and 45 at 1 and 2 years , respectively , but were stable in controls ( 46 to 48 ) . Median Functional Assessment of Cancer Treatment-Endocrine Symptoms scores ( range , 0 to 72 ) for patients improved from 57 ( on chemotherapy ) to 59 and 61 at 1 and 2 years , respectively , and were stable in controls ( 64 to 65 ) . Differences between patients and controls remained significant for these scales . The incidence of moderate-severe cognitive dysfunction by the High Sensitivity Cognitive Screen decreased in patients from 16 % ( on chemotherapy ) to 4.4 % and 3.8 % and in controls from 5 % to 3.6 % and 0 % at 1 and 2 years , respectively . There were minimal differences between estrogen receptor-positive patients who started hormonal therapy ( mainly tamoxifen ) after chemotherapy and estrogen receptor-negative patients who did not . Differences in quality of life between patients and controls were significant only at baseline . CONCLUSION Fatigue , menopausal symptoms , and cognitive dysfunction are important adverse effects of chemotherapy that improve in most patients . Hormonal treatment has minimal impact on them PURPOSE To examine the impact of age and cognitive reserve on cognitive functioning in patients with breast cancer who are receiving adjuvant treatments . PATIENTS AND METHODS Patients with breast cancer exposed to chemotherapy ( n = 60 ; mean age , 51.7 years ) were evaluated with a battery of neuropsychological and psychological tests before treatment and at 1 , 6 , and 18 months after treatment . Patients not exposed to chemotherapy ( n = 72 ; mean age , 56.6 years ) and healthy controls ( n = 45 ; mean age , 52.9 years ) were assessed at matched intervals . RESULTS Mixed-effects modeling revealed significant effects for the Processing Speed and Verbal Ability domains . For Processing Speed , a three-way interaction among treatment group , age , and baseline cognitive reserve ( P < .001 ) revealed that older patients with lower baseline cognitive reserve who were exposed to chemotherapy had lower performance on Processing Speed compared with patients not exposed to chemotherapy ( P = .003 ) and controls ( P < .001 ) . A significant group by time interaction for Verbal Ability ( P = .01 ) suggested that the healthy controls and no chemotherapy groups improved over time . The chemotherapy group failed to improve at 1 month after treatment but improved during the last two follow-up assessment s. Exploratory analyses suggested a negative effect of tamoxifen on Processing Speed ( P = .036 ) and Verbal Memory ( P = .05 ) in the no-chemotherapy group . CONCLUSION These data demonstrated that age and pretreatment cognitive reserve were related to post-treatment decline in Processing Speed in women exposed to chemotherapy and that chemotherapy had a short-term impact on Verbal Ability . Exploratory analysis of the impact of tamoxifen suggests that this pattern of results may be due to a combination of chemotherapy and tamoxifen PURPOSE To prospect ively examine alterations in working memory ( WM ) -associated brain activation related to breast cancer and treatment by using functional magnetic resonance imaging . PATIENTS AND METHODS Patients treated with chemotherapy ( CTx+ ; n = 16 ) or without chemotherapy ( CTx- ; n = 12 ) and healthy controls ( n = 15 ) were scanned during an n-back task at baseline ( after surgery but before radiation , chemotherapy , and /or antiestrogen treatment ) , 1 month after completion of chemotherapy ( M1 ) , and 1 year later ( Y1 ) , or at yoked intervals for CTx- and controls . SPM5 was used for all image analyses , which included cross-sectional between-group and group-by-time interaction and longitudinal within-group analyses , all using a statistical threshold of 0.001 . RESULTS At baseline , patients with cancer showed increased bifrontal and decreased left parietal activation compared with controls . At M1 , both cancer groups showed decreased frontal hyperactivation compared with controls , with increased hyperactivation at Y1 . These cross-sectional findings were confirmed by group-by-time interaction analyses , which showed frontal activation decreases from baseline to M1 in patients compared with controls . Within-group analyses showed different patterns of longitudinal activation change by treatment group ( CTx+ or CTx- ) , with prominent alterations in the frontal lobes bilaterally . CONCLUSION Significant frontal lobe hyperactivation to support WM was found in patients with breast cancer . Superimposed on this background , patients showed decreased frontal activation at M1 , with partial return to the previously abnormal baseline at Y1 . These functional changes correspond to frontal lobe regions where we previously reported structural changes in this cohort and provide prospect i ve , longitudinal data that further eluci date mechanisms underlying cognitive effects related to breast cancer and its treatment The aim of this study is to use functional magnetic resonance imaging ( fMRI ) to prospect ively examine pre-treatment predictors of post-treatment fatigue and cognitive dysfunction in women treated with adjuvant chemotherapy for breast cancer . Fatigue and cognitive dysfunction often co-occur in women treated for breast cancer . We hypothesized that pre-treatment factors , unrelated to chemotherapy per se , might increase vulnerability to post-treatment fatigue and cognitive dysfunction . Patients treated with ( n = 28 ) or without chemotherapy ( n = 37 ) and healthy controls ( n = 32 ) were scanned coincident with pre- and one-month post-chemotherapy during a verbal working memory task ( VWMT ) and assessed for fatigue , worry , and cognitive dysfunction . fMRI activity measures in the frontoparietal executive network were used in multiple linear regression to predict post-treatment fatigue and cognitive function . The chemotherapy group reported greater pre-treatment fatigue than controls and showed compromised neural response , characterized by higher spatial variance in executive network activity , than the non-chemotherapy group . Also , the chemotherapy group reported greater post-treatment fatigue than the other groups . Linear regression indicated that pre-treatment spatial variance in executive network activation predicted post-treatment fatigue severity and cognitive complaints , while treatment group , age , hemoglobin , worry , and mean executive network activity levels did not predict these outcomes . Pre-treatment neural inefficiency ( indexed by high spatial variance ) in the executive network , which supports attention and working memory , was a better predictor of post-treatment cognitive and fatigue complaints than exposure to chemotherapy per se . This executive network compromise could be a pre-treatment neuromarker of risk , indicating patients most likely to benefit from early intervention for fatigue and cognitive dysfunction Adjuvant chemotherapy is associated with improvements in long-term cancer survival . However , reports of cognitive impairment following treatment emphasize the importance of underst and ing the long-term effects of chemotherapy on brain functioning . Cognitive deficits found in chemotherapy patients suggest a change in brain functioning that affects specific cognitive domains such as attentional processing and executive functioning . This study examined the processes potentially underlying these changes in cognition by examining brain functional connectivity pre- and post-chemotherapy in women with breast cancer . Functional connectivity examines the temporal correlation between spatially remote brain regions in an effort to underst and how brain networks support specific cognitive functions . Nine women diagnosed with breast cancer completed a functional magnetic resonance imaging ( fMRI ) session before chemotherapy , 1 month after , and 1 year after the completion of chemotherapy . Seed-based functional connectivity analyses were completed using seeds in the intraparietal sulcus ( IPS ) to examine connectivity in the dorsal anterior attention network and in the posterior cingulate cortex ( PCC ) to examine connectivity in the default mode network . Results showed decreased functional connectivity 1 month after chemotherapy that partially returned to baseline at 1 year in the dorsal attention network . Decreased connectivity was seen in the default mode network at 1 month and 1 year following chemotherapy . In addition , increased subjective memory complaints were noted at 1 month and 1 year post-chemotherapy . These findings suggest a detrimental effect of chemotherapy on brain functional connectivity that is potentially related to subjective cognitive assessment In the present study , we sought to investigate which brain structures are recru
Output:
| Although there was heterogeneity in the neuropsychological measures used to assess executive functioning , tests could be grouped into the subcomponents they assessed .
Inhibition appears relatively spared from the effects of chemotherapy , whereas impairments in shifting and updating are more commonly found following chemotherapy . |
MS212465 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Stress can affect health . There is a growing need for the evaluation and application of professional stress management options , i.e , stress reduction . Mind/body medicine serves this goal , e.g , by integrating self-care techniques into medicine and health care . Tai Chi ( TC ) can be classified as such a mind/body technique , potentially reducing stress and affecting physical as well as mental health parameters , which , however , has to be examined further . MATERIAL / METHODS We conducted a prospect i ve , longitudinal pilot study over 18 weeks for the evaluation of subjective and objective clinical effects of a Yang style TC intervention in young adults ( beginners ) by measuring physiological ( blood pressure , heart rate , saliva cortisol ) and psychological ( SF-36 , perceived stress , significant events ) parameters , i.e , direct or indirect indicators of stress and stress reduction , in a non-r and omised/-controlled , yet non-selected cohort ( n=21 ) by pre-to-post comparison and in follow-up . SF-36 values were also compared with the age-adjusted norm population , serving as an external control . Additionally , we measured diurnal cortisol profiles in a cross-sectional sub- study ( n=2 + 2 , pre-to-post ) , providing an internal r and om control sub- sample . RESULTS Only nine participants completed all measurements . Even so , we found significant ( p<0.05 ) reductions of saliva cortisol ( post and follow-up ) , which seems to be an indicator of general stress reduction . A significant decrease in perceived mental stress ( post ) proved even highly significant ( p<0.01 ) in the follow-up , whereas physical stress perception declined to a much lesser degree . Significant improvements were also detected for the SF-36 dimensions general health perception , social functioning , vitality , and mental health/psychological well-being . Thus , the summarized mental health measures all clearly improved , pointing towards a predominantly psychological impact of TC . CONCLUSIONS Subjective health increased , stress decreased ( objective ly and subjectively ) during TC practice . Future studies should confirm this observation by rigorous methodology and by further combining physical and psychological measurements with basic research , thereby also gaining knowledge of autoregulation and molecular physiology that possibly underlies mind/body medicine Background : Dance and yoga have been shown to produce improvements in psychological well-being . Purpose : The aim of this study was to examine some of the psychological and neuroendocrine responses to these activities . Methods : Sixty-nine healthy college students participated in one of three 90-min classes : African dance ( n = 21 ) , Hatha yoga ( n = 18 ) , or a biology lecture as a control session ( n = 30 ) . Before and after each condition participants completed the Perceived Stress Scale ( PSS ) , completed the Positive Affect and Negative Affect Schedule , and provided a saliva sample for cortisol . Results : There were significant reductions in PSS and negative affect ( ps < .0001 ) and Time × Treatment interactions ( ps < .0001 ) such that African dance and Hatha yoga showed significant declines , whereas there was no significant change in biology lecture . There was no significant main effect for positive affect ( p = .53 ) , however there was a significant interaction effect ( p < .001 ) such that positive affect increased in African dance , decreased in biology lecture , and did not change significantly in Hatha yoga . There was a significant main effect for salivary cortisol ( p < .05 ) and a significant interaction effect ( p < .0001 ) such that cortisol increased in African dance , decreased in Hatha yoga , and did not change in biology . Changes in cortisol were not significantly related to changes in psychological variables across treatments . There was 1 significant interaction effect ( p = .04 ) such that change in positive affect and change in cortisol were negatively correlated in Hatha yoga but positively correlated in African dance and biology . Conclusions : Both African dance and Hatha yoga reduced perceived stress and negative affect . Cortisol increased in African dance and decreased in Hatha yoga . Therefore , even when these interventions produce similar positive psychological effects , the effects may be very different on physiological stress processes . One factor that may have particular salience is the amount of physiological arousal produced by the intervention PURPOSE Tai Chi exercise , an ancient Chinese martial art , has drawn more and more attention for its health benefits . The purpose of the study was to identify the effects of a Sun-style Tai Chi exercise on arthritic symptoms ( joint pain and stiffness ) , motivation for performing health behaviors , and the performance of health behaviors among older women with osteoarthritis . METHODS Total of 72 women with the mean age of 63 years old were recruited from out patients clinic or public health centers according to the inclusion criteria and assigned r and omly to either the Tai Chi exercise group or the control . A Sun-style Tai Chi exercise has been provided three times a week for the first two weeks , and then once a week for another 10 weeks . In 12 weeks of study period , 22 subjects in the Tai Chi exercise group and 21 subjects in the control group completed the posttest measure with the dropout rate of 41 % . Outcome variables included arthritic symptoms measured by K-WOMAC , motivation for health behavior , and health behaviors . RESULTS At the completion of the 12 week Tai Chi exercise , the Tai Chi group perceived significantly less joint pain ( t=-2.19 , p=0.03 ) and stiffness ( t=-2.24 , p=0.03 ) , perceived more health benefits ( t=2.67 , p=0.01 ) , and performed better health behaviors ( t=2.35 , p=0.02 ) , specifically for diet behavior ( t=2.06 , p=0.04 ) and stress management ( t=2.97 , p=0.005 ) . CONCLUSION A Sun-style Tai Chi exercise was found as beneficial for women with osteoarthritis to reduce their perceived arthritic symptoms , improve their perception of health benefits to perform better health behaviors The present study aim ed at assessing the effects of a set of yoga practice s on normal adults ( n = 37 ) , children ( n = 86 ) , and patients with rheumatoid arthritis ( n = 20 ) . An equal number of normal adults , children , and patients with rheumatoid arthritis who did not practice yoga were studied under each category , forming respective control groups . Yoga and control group subjects were assessed at baseline and after varying intervals , as follows , adults after 30 days , children after 10 days and patients after 15 days , based on the duration of the yoga program , which they attended , which was already fixed . H and grip strength of both h and s , measured with a grip dynamometer , increased in normal adults and children , and in rheumatoid arthritis patients , following yoga , but not in the corresponding control groups , showing no re-test effect . Adult female volunteers and patients showed a greater percentage improvement than corresponding adult males . This gender-based difference was not observed in children . Hence yoga practice improves h and grip strength in normal persons and in patients with rheumatoid arthritis , though the magnitude of improvement varies with factors such as gender and age Background : Mindfulness-based stress reduction ( MBSR ) proposes a systematic program for reduction of suffering associated with a wide range of medical conditions . Studies suggest improvements in general aspects of well-being , including quality of life ( QoL ) , coping and positive affect , as well as decreased anxiety and depression . Methods : A quasi-experimental study examined effects of an 8-week MBSR intervention among 58 female patients with fibromyalgia ( mean , 52 ± 8 years ) who underwent MBSR or an active social support procedure . Participants were assigned to groups by date of entry , and 6 subjects dropped out during the study . Self-report measures were vali date d German inventories and included the following scales : visual analog pain , pain perception , coping with pain , a symptom checklist and QoL. Pre- and postintervention measurements were made . Additionally , a 3-year follow-up was carried out on a subgroup of 26 participants . Results : Pre- to postintervention analyses indicated MBSR to provide significantly greater benefits than the control intervention on most dimensions , including visual analog pain , QoL subscales , coping with pain , anxiety , depression and somatic complaints ( Cohen d effect size , 0.40–1.10 ) . Three-year follow-up analyses of MBSR participants indicated sustained benefits for these same measures ( effect size , 0.50–0.65 ) . Conclusions : Based upon a quasi-r and omized trial and long-term observational follow-up , results indicate mindfulness intervention to be of potential long-term benefit for female fibromyalgia patients There is growing evidence that yoga may offer a safe and cost-effective intervention for Type 2 Diabetes mellitus ( DM 2 ) . However , systematic review s are lacking . This article critically review s the published literature regarding the effects of yoga-based programs on physiologic and anthropometric risk profiles and related clinical outcomes in adults with DM 2 . We performed a comprehensive literature search using four computerized English and Indian scientific data bases . The search was restricted to original studies ( 1970–2006 ) that evaluated the metabolic and clinical effects of yoga in adults with DM 2 . Studies targeting clinical population s with cardiovascular disorders that included adults with comorbid DM were also evaluated . Data were extracted regarding study design , setting , target population , intervention , comparison group or condition , outcome assessment , data analysis and presentation , follow-up , and key results , and the quality of each study was evaluated according to specific predetermined criteria . We identified 25 eligible studies , including 15 uncontrolled trials , 6 non-r and omized controlled trials and 4 r and omized controlled trials ( RCTs ) . Overall , these studies suggest beneficial changes in several risk indices , including glucose tolerance and insulin sensitivity , lipid profiles , anthropometric characteristics , blood pressure , oxidative stress , coagulation profiles , sympathetic activation and pulmonary function , as well as improvement in specific clinical outcomes . Yoga may improve risk profiles in adults with DM 2 , and may have promise for the prevention and management of cardiovascular complications in this population . However , the limitations characterizing most studies preclude drawing firm conclusions . Additional high- quality RCTs are needed to confirm and further eluci date the effects of st and ardized yoga programs in population s with DM 2 Objectives . This study compares the effects of an integrated yoga program with brief supportive therapy in breast cancer out patients undergoing adjuvant radiotherapy at a cancer center . Methods . Eighty-eight stage II and III breast cancer out patients are r and omly assigned to receive yoga ( n = 44 ) or brief supportive therapy ( n = 44 ) prior to radiotherapy treatment . Assessment s include diurnal salivary cortisol levels 3 days before and after radiotherapy and self-ratings of anxiety , depression , and stress collected before and after 6 weeks of radiotherapy . Results . Analysis of covariance reveals significant decreases in anxiety ( P < .001 ) , depression ( P = .002 ) , perceived stress ( P < .001 ) , 6 a.m. salivary cortisol ( P = .009 ) , and pooled mean cortisol ( P = .03 ) in the yoga group compared with controls . There is a significant positive correlation between morning salivary cortisol level and anxiety and depression . Conclusion . Yoga might have a role in managing self-reported psychological distress and modulating circadian patterns of stress hormones in early breast cancer patients undergoing adjuvant radiotherapy Context Yoga combines exercise with achieving a state of mental focus through breathing . In the United States , 1 million people practice yoga for low back pain . Contribution The authors recruited patients who had a recent primary care visit for low back pain and r and omly assigned 101 to yoga or conventional exercise or a self-care book . Patients in the yoga and exercise groups reported good adherence at 26 weeks . Compared with self-care , symptoms were milder and function was better with yoga . The exercise group had intermediate outcomes . Symptoms improved between 12 and 26 weeks only with yoga . Implication s Yoga was a more effective treatment for low back pain than a self-care book . The Editors Most treatments for chronic low back pain have modest efficacy at best ( 1 ) . Exercise is one of the few proven treatments for chronic low back pain ; however , its effects are often small , and no form has been shown to be clearly better than another ( 2 - 5 ) . Yoga , which often couples physical exercise with breathing , is a popular alternative form of mindbody therapy . An estimated 14 million Americans practice d yoga in 2002 ( 6 ) , including more than 1 million who used it as a treatment for back pain ( 7 , 8) . Yoga may benefit patients with back pain simply because it involves exercise or because of its effects on mental focus . We found no published studies in western biomedical literature that evaluated yoga for chronic low back pain ; therefore , we design ed a clinical trial to evaluate its effectiveness and safety for this condition . Methods Study Design and Setting This r and omized , controlled trial compared the effects of yoga classes with conventional exercise classes and with a self-care book in patients with low back pain that persisted for at least 12 weeks . The study was conducted at Group Health Cooperative , a nonprofit , integrated health care system with approximately 500000 enrollees in Washington State and Idaho . The Group Health Cooperative institutional review board approved the study protocol , and all study participants gave oral informed consent before the eligibility screening and written consent before the baseline interview and r and omization . Patients Patients from Group Health Cooperative were recruited for 12-week sessions of classes that were conducted between June and December 2003 . We mailed letters describing the study to 6913 patients between 20 and 64 years of age who had visited a primary care provider for treatment of back pain 3 to 15 months before the study ( according to electronic visit records ) . We also advertised the study in the health plan '
Output:
| Collectively , these studies suggest that specific mind-body practice s may help alleviate pain and enhance physical function in adults suffering from osteoarthritis of the knee . |
MS212466 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The optimal induction for older adults with acute myeloid leukemia ( AML ) is unknown . Several anthracyclines have been proposed , but the data remain equivocal . Additionally , few prospect i ve trials of priming with hematopoietic growth factors to cycle leukemia cells prior to induction chemotherapy have been conducted . Three hundred and sixty-two older adults with previously untreated AML were r and omized to either daunorubicin , idarubicin or mitoxantrone with a st and ard dose of cytarabine as induction therapy . In addition , 245 patients were also r and omized to receive granulocyte-macrophage colony-stimulating factor ( GM-CSF ) or placebo beginning 2 days prior to induction chemotherapy and continuing until marrow aplasia . No difference was observed in the disease-free overall survival or in toxicity among patients receiving any of the 3 induction regimens or among those receiving growth factor or placebo for priming . However , the complete remission rate for the first 113 analyzable patients , who did not participate in the priming study and started induction therapy 3 to 5 days earlier than those who did , was significantly higher ( 50 % versus 38 % ; P = .03 ) . None of the anthracyclines is associated with improved outcome in older adults . Priming with hematopoietic growth factor did not improve response when compared with placebo . Furthermore , delaying induction therapy in older adults may lead to a lower complete remission rate The role of glycosylated recombinant human granulocyte colony-stimulating factor ( G-CSF ) in the induction treatment of older adults with acute myeloid leukemia ( AML ) is still uncertain . In this trial , a total of 722 patients with newly diagnosed AML , median age 68 years , were r and omized into 4 treatment arms : ( A ) no G-CSF ; ( B ) G-CSF during chemotherapy ; ( C ) G-CSF after chemotherapy until day 28 or recovery of polymorphonuclear leukocytes ; and ( D ) G-CSF during and after chemotherapy . The complete remission ( CR ) rate was 48.9 % in group A , 52.2 % in group B , 48.3 % in group C , and 64.4 % in group D. Analysis according to the 2 x 2 factorial design indicated that the CR rate was significantly higher in patients who received G-CSF during chemotherapy ( 58.3 % for groups B + D vs 48.6 % for groups A + C ; P = .009 ) , whereas no significant difference was observed between groups A + B and C + D ( 50.6 % vs 56.4 % , P = .12 ) . In terms of overall survival , no significant differences were observed between the various groups . Patients who received G-CSF after chemotherapy had a shorter time to neutrophil recovery ( median , 20 vs 25 days ; P < .001 ) and a shorter hospitalization ( mean , 27.2 vs 29.7 days ; P < .001 ) . We conclude that although priming with G-CSF can improve the CR rate , the use of G-CSF during and /or after chemotherapy has no effect on the long-term outcome of AML in older patients Older age is a poor prognosis factor in acute myeloid leukemia ( AML ) . This double-blind trial was design ed to test the hypothesis that granulocyte colony-stimulating factor ( G-CSF ) used as supportive care could improve the treatment of elderly AML patients . Two hundred thirty-four patients 55 or more years of age with a morphologic diagnosis of de novo or secondary AML , French-American-British ( FAB ) M0-M7 , excluding M3 , were r and omly assigned to a st and ard induction regimen ( daunorubicin at 45 mg/m2 intravenously [ IV ] on days 1 through 3 and Ara-C at 200 mg/m2 IV continuous infusion on days 1 through 7 ) plus either placebo or G-CSF ( 400 microg/m2 IV over 30 minutes once daily ) . Results are reported here for 211 central ly confirmed cases of non-M3 AML . The two groups were well balanced in demographic , clinical , and hematological parameters , with median ages of 68 years in the G-CSF and 67 years in the placebo groups . The complete response ( CR ) rate was not significantly better in the G-CSF group : 50 % in the placebo and 41 % in the G-CSF group ( one-tailed P = .89 ) . Median overall survival was also similar , 9 months ( 95 % confidence interval [ CI ] , 7 to 10 months ) in the placebo and 6 months ( 95 % CI , 3 to 8 months ) in the G-CSF arms ( P = .71 ) . We found a significant 15 % reduction in the time to neutrophil recovery in the G-CSF group ( P = .014 ) . G-CSF had no impact on recovery from thrombocytopenia ( P = .80 ) or duration of first hospitalization ( P = .27 ) . When infection complications were evaluated , G-CSF had a beneficial effect on the duration but not on incidence of infection . G-CSF patients had fewer days with fever and shorter duration of antibiotic use . However , there was no difference in the frequency of total documented infections or in the number of fatal infections ( 19 % placebo v 20 % G-CSF ) . In this study of elderly AML patients , G-CSF improved clinical parameters of duration of neutropenia and antibiotic use , but did not change CR rate or survival or shorten hospitalization The role of granulocyte colony stimulating factor ( G‐CSF ) as supportive therapy following intensive induction chemotherapy for acute myeloid leukaemia ( AML ) in adults was investigated in a r and omized trial . G‐CSF ( Lenograstim , 263 μg/d ) or placebo was administered from day 8 after the end of chemotherapy until neutrophil recovery to 0·5 × 109/l ( or for up to 10 d ) . Eight hundred and three patients were entered . Neutrophil recovery was quicker with G‐CSF ( P < 0·0001 ) , but this did not lead to differences in the number , severity or duration of infections . There were no substantial supportive care savings , although G‐CSF patients spent 2 d less in hospital ( P = 0·01 ) . Complete remission ( CR ) rates were similar between arms ( 73 % G‐CSF , 75 % placebo , P = 0·5 ) , as were reasons for failure ( induction death : P = 0·7 ; resistant disease : P = 0·5 ) and , for remitters , 5‐year disease‐free survival ( 34 % vs. 38 % , P = 0·3 ) . Overall survival at 5 years was 29 % with G‐CSF vs. 36 % with placebo ( P = 0·10 ) . Both CR rate ( P = 0·006 ) and overall survival ( P = 0·006 ) were worse with G‐CSF in patients aged < 40 years , but this may be a chance effect . There is some evidence from this trial of an adverse effect of G‐CSF but these data need to be viewed in the context of the evidence from the other trials A r and omized treated/non-treated study of rG.CSF ( 5 micrograms/kg/d , d.i.v . ) in patients with acute myelogenous leukemia was conducted to assess its efficacy on fever ( > or = 38 degrees C ) or documented infection after induction therapy . Of 95 patients enrolled , 46 patients were evaluable for safety and 43 for efficacy in the treated group of 47 patients while 37 of 48 patients were eligible for data analysis in the untreated group . Mare patients showed a recovery in the blood neutrophil count ( to > 1,000/microliters ) during rG.CSF treatment ( 14 days ) than in the non-treated group ( p = 0.039 ) while the number of febrile patients and duration of fever did not significantly differ between the two groups . The treatment with rG.CSF enabled an early recovery in neutrophil count in the patients with neutropenia and overt signs of infection after induction therapy , but there was no hastened allevistion of symptoms of infection in these patients Pre clinical data suggest that retinoids , eg , all-trans retinoic acid ( ATRA ) , lower concentrations of antiapoptotic proteins such as bcl-2 , possibly thereby improving the outcome of anti-acute myeloid leukemia ( AML ) chemotherapy . Granulocyte colony-stimulating factor ( G-CSF ) has been considered to be potentially synergistic with ATRA in this regard . Accordingly , we r and omized 215 patients with newly diagnosed AML ( 153 patients ) or high-risk myelodysplastic syndrome ( MDS ) ( refractory anemia with excess blasts [ RAEB ] or RAEB-t , 62 patients ) to receive fludarabine + ara-C + idarubicin ( FAI ) alone , FAI + ATRA , FAI + G-CSF , or FAI + ATRA + G-CSF . Eligibility required one of the following : age over 71 years , a history of abnormal blood counts before M.D. And erson ( MDA ) presentation , secondary AML/MDS , failure to respond to one prior course of chemotherapy given outside MDA , or abnormal renal or hepatic function . For the two treatment arms containing ATRA , ATRA was given 2 days ( day-2 ) before beginning and continued for 3 days after completion of FAI . For the two treatment arms including G-CSF , G-CSF began on day-1 and continued until neutrophil recovery . Patients with white blood cell ( WBC ) counts > 50,000/microL began ATRA on day 1 and G-CSF on day 2 . Events ( death , failure to achieve complete remission [ CR ] , or relapse from CR ) have occurred in 77 % of the 215 patients . Reflecting the poor prognosis of the patients entered , the CR rate was only 51 % , median event-free survival ( EFS ) time once in CR was 36 weeks , and median survival time was 28 weeks . A Cox regression analysis indicated that , after accounting for patient prognostic variables , none of the three adjuvant treatment combinations ( FAI + ATRA , FAI + G , FAI + ATRA + G ) affected survival , EFS , or EFS once in CR compared with FAI . Similarly , there were no significant effects of either ATRA ignoring G-CSF , or of G-CSF ignoring ATRA . As previously found , a diagnosis of RAEB or RAEB-t rather than AML was insignificant . There were no indications that the effect of ATRA differed according to cytogenetic group , diagnosis ( AML or MDS ) , or treatment schedule . Logistic regression analysis indicated that , after accounting for prognosis , addition of G-CSF + /- ATRA to FAI improved CR rate versus either FAI or FAI + ATRA , but G-CSF had no effect on the other outcomes . We conclude that addition of ATRA + /- G-CSF to FAI had no effect on CR rate , survival , EFS , or EFS in CR in poor prognosis , newly diagnosed AML or high-risk MDS The optimum chemotherapy schedule for reinduction of patients with high-risk acute myeloid leukemia ( relapsed , resistant/refractory , or adverse genetic disease ) is uncertain . The MRC AML ( Medical Research Council Acute Myeloid Leukemia ) Working Group design ed a trial comparing fludarabine and high-dose cytosine ( FLA ) with st and ard chemotherapy comprising cytosine arabinoside , daunorubicin , and etoposide ( ADE ) . Patients were also r and omly assigned to receive filgrastim ( G-CSF ) from day 0 until neutrophil count was greater than 0.5 x 10(9)/L ( or for a maximum of 28 days ) and all-trans retinoic acid ( ATRA ) for 90 days . Between 1998 and 2003 , 405 patients were entered : 250 were r and omly assigned between FLA and ADE ; 356 to G-CSF versus no G-CSF ; 362 to ATRA versus no ATRA . The complete remission rate was 61 % with 4-year disease-free survival of 29 % . There were no significant differences in the CR rate , deaths in CR , relapse rate , or DFS between ADE and FLA , although survival at 4 years was worse with FLA ( 16 % versus 27 % , P = .05 ) . Neither the addition of ATRA nor G-CSF demonstrated any differences in the CR rate , relapse rate , DFS , or overall survival between the groups . In conclusion these findings indicate that FLA may be inferior to st and ard chemotherapy in high-risk AML and that the outcome is not improved with the addition of either G-CSF or ATRA Summary . To investigate the efficacy and safety of granulocyte colony‐stimulating factor ( G‐CSF ) in patients with acute myelogenous leukaemia , a multicentre r and omized study was performed . From October 1993 to September 1996 , 270 patients with newly diagnosed acute myelogenous leukaemia were r and omized to G‐CSF or control groups after remission induction therapy . The G‐CSF group received G‐CSF ( Filgrastim ) from 48 h after the completing chemotherapy until the absolute neutrophil count exceeded 1·5 × 109/l . The control group did not receive G‐CSF unless severe infection occurred . There were 245 evaluable patients ( 120 and 125 in the G‐CSF and
Output:
| Prophylactic CSF administration reduces the time to neutrophil recovery and length of hospitalization , but has no impact on documented infections or outcome . |
MS212467 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: BACKGROUND The effect of supplementation with a fixed combination of antioxidants ( vitamins C and E , beta-carotene and selenium ) was monitored on the speed of attaining euthyroidism in a group of patients with Graves ' disease , treated with methimazole . METHODS The activity of glutathione peroxidase in whole blood and the concentrations of selenium , pituitary and thyroid hormones in serum were measured , prior to commencement of therapy and after 30 and 60 days . RESULTS Patients who received supplementation with antioxidants in addition to therapy with methimazole ( Group A , n=29 ) attained euthyroidism faster than the patients treated with only methimazole ( Group B , n=28 ) . The concentration of selenium in the serum of patients in Group A increased significantly during treatment ( p<0.001 ) , while there was no statistically significant change in the patients in Group B. The concentration of selenium in the serum between the groups differed statistically significantly 30 days ( p<0.05 ) and 60 days ( p<0.01 ) after the commencement of therapy . Activity of glutathione peroxidase in whole blood increased during treatment in both groups of patients . However , a statistically more significant increase occurred in Group A compared to Group B , 30 days after the commencement of therapy ( p<0.01 ) . CONCLUSION The results of the study clearly indicate that supplementation with antioxidants in the treatment of Graves ' disease is justified , particularly those containing selenium We compared the effects of high and low dosages of antithyroid drugs in 113 patients with Graves ' hyperthyroidism . The patients were r and omly divided into 2 groups . In group A , 65 patients received either methimazole ( MMI ) : 60 + /- 14.5 mg/day ( mean + /- SD ) ; range 40 - 100 mg/day , or propylthiouracil ( PTU ) : 693 + /- 173 mg/day ; range 500 - 1200 mg/day . These high doses were maintained throughout treatment with later addition of 50 - 75 micrograms T3 daily . Forty eight patients ( group B ) were treated with lower doses of MMI or PTU without thyroid hormone addition . The maintenance dose of MMI was 13.6 + /- 7 mg/day ( range 5 - 25 mg/day ) and that of PTU was 180 + /- 58 mg/day ( range 100 - 300 mg/day ) . The treatment period was 15.1 + /- 4.2 ( range 10 - 30 ) months for group A and 13.5 + /- 2.2 ( range 12 - 20 ) months for group B. Remission occurred in 75.4 % patients from group A and in 41.6 % patients from group B ( P less than 0.001 ) . The mean follow-up was 42 + /- 14 months ( 17 - 81 months ) . The free T4 index ( FT4I ) in group A remained below the normal range during treatment . The mean FT4I , obtained during the course of treatment , of patients who went into remission from group A was significantly ( P less than 0.001 ) lower than in relapsed patients ( 4.8 vs. 6.5 ) . Moreover , there was an inverse correlation between mean FT4I and maintenance daily dose of either MMI ( r = -0.567 ; P less than 0.001 ) , or PTU ( r = -0.379 ; P less than 0.01 ) . A fall in microsomal antibody ( MCHA ) titer occurred mainly in remission patients , and was more significant ( P less than 0.05 ) in group A patients . In contrast , 11 ( 7 from group B ) of the 16 patients with an increase of microsomal antibody levels relapsed . The frequency of negative tests of thyroid-stimulating antibody was higher in group A patients ( 71 % ) than in group B ( 29 % ) at the end of therapy ( P less than 0.01 ) . No correlation was found between thyroid T3 suppressibility and either mean FT4I or thyroid-stimulatory antibody activity during treatment . Our findings show that patients treated with high doses of PTU or MMI throughout treatment have a higher remission rate when compared to those treated with a more conventional regimen . These results support the hypothesis that large antithyroid drug doses may have greater immunosuppressive effects than low dosage regimens . Furthermore , a high dosage regimen could permit the restoration of the immune surveillance mechanisms and , thus , lasting remission of Graves ' disease UNLABELLED Graves ' disease ( GD ) patients treated with antithyroid drugs ( ATD ) have overall relapse rates of 30 - 50 % after ATD discontinuation . Conflicting data have been reported with regard to the usefulness of adding thyroxine ( I-T4 ) during and after ATD treatment . Also , clinicians are still in search of useful factors to predict remission/recurrence after ATD withdrawal . Eighty two consecutive patients were treated with ATD for 15 months , combined with 12 months of I-T4 . Then , patients were r and omized ( placebo-controlled double blind protocol ) to continuing I-T4 versus a placebo for one year . RESULTS I-T4 administration during and after ATD treatment did not affect favorably the outcome , the final recurrence rate being 31 % , in both placebo and I-T4 groups . Two factors were identified as independent and synergistic markers of a significantly increased risk of recurrence after ATD withdrawal : smoking and TSH receptor antibodies ( TSHR-Ab ) remaining positive at the end of ATD . Non smoking patients with a negative TSHR-Ab ( end ATD ) had a low ( 18 % ) recurrence risk , while smoking patients also with a negative TSHR-Ab had a higher ( 57 % ) recurrence risk . Non smoking patients with a positive TSHR-Ab ( end ATD ) had a 86 % recurrence risk . Finally , smoking patients with a positive TSHR-Ab ( end ATD ) all recurred within 6 months . CONCLUSIONS 1 ) T4 administration after ATD withdrawal does not improve recurrence rates ; 2 ) two parameters , smoking and positive TSHR-Ab ( at end ATD ) , were valid -- albeit not absolute-predictors of the risk of recurrence in ATD-treated patients with Graves ' disease BACKGROUND Antithyroid drugs are effective in patients with hyperthyroidism due to Graves ' disease , but the rate of recurrence after treatment is high . In a recent Japanese study , adjunctive treatment with thyroxine ( T4 ) was associated with a recurrence rate 20 times lower than that among patients who received only an antithyroid drug . If these results are confirmed , combined therapy with an antithyroid drug and T4 might become the treatment of choice for all patients with Graves ' hyperthyroidism . METHODS We treated 111 patients ( 89 women and 22 men ) who had Graves ' hyperthyroidism . All patients initially received 40 mg of carbimazole daily for one month . Then one group received carbimazole alone for 17 months ( 52 patients ) , and the other group received carbimazole plus T4 for 17 months and T4 alone for 18 months ( 59 patients ) . In the carbimazole group , the dose was adjusted after one month to maintain a normal serum thyrotropin concentration . In the carbimazole-T4 group , the dose of carbimazole was not changed , but 100 micrograms of T4 per day was added to the regimen and the dose was adjusted to maintain an undetectable serum thyrotropin concentration ( < 0.04 microU per milliliter ) . RESULTS At the time of our analysis , 53 of the 111 patients had completed at least 3 months of follow-up ( median , 12 months ) after carbimazole was withdrawn . Hyperthyroidism recurred in eight patients in each group after a mean ( + /- SD ) of 6 + /- 4 months in the carbimazole group and 7 + /- 4 months in the carbimazole-T4 group . There was no difference between the recurrence rates in the two groups , despite the fact that serum thyrotropin concentrations were undetectable in 73 percent of patients in the carbimazole-T4 group on at least 75 percent of their visits . CONCLUSIONS The administration of T4 to patients with Graves ' disease during carbimazole treatment and after its withdrawal neither delays nor prevents the recurrence of hyperthyroidism OBJECTIVE In Graves ' hyperthyroidism treated with antithyroid drugs ( ATD ) , the overall relapse rate reaches 30 - 50 % following ATD discontinuation . Conflicting results have previously been reported with regard to the usefulness of combining ATD with thyroxine ( l-T4 ) , and thereafter maintaining l-T4 treatment after ATD withdrawal . Also , clinicians are in search of useful parameters to predict the risk of a recurrence of hyperthyroidism after ATD treatment . DESIGN Eighty-two consecutive patients ( 70 women and 12 men ; mean age 36 years ) with a first episode of Graves ' hyperthyroidism were investigated prospect ively ; they were treated with ATD for a total of 15 months , combined with l-T4 ( for at least 12 months ) after they had reached euthyroidism , with the aim of maintaining serum TSH below 2.5 mU/l during the combined therapy . Following ATD discontinuation , the patients were r and omly assigned ( double-blind placebo-controlled trial ) to taking 100 microg/day l-T4 ( vs placebo ) for an additional year . METHODS The following determinations were carried out at initial diagnosis : serum total T4 and tri-iodothyronine ( T3 ) , free T4 and T3 , TSH , TSH-receptor antibodies ( TSHR-Ab ) , thyroid scintigraphy and echography . During ATD treatment , serum free T4 and T3 and TSH concentrations were recorded after 1 ( optional ) , 2 , 4 , 6 , 9 , 12 and 15 months , and echography at the end of ATD treatment . During the r and omized trial , serum free T4 and T3 and TSH concentrations were checked every 3 months ( or until a recurrence ) . TSHR-Ab titers were measured at initial diagnosis , after 6 months with ATD , and at the end of ATD treatment . RESULTS l-T4 administration , both during and after ATD treatment , did not improve the final outcome and recurrence rates were similar in placebo and l-T4-treated patients ( 30 % ) . Two parameters were identified that might be useful to help predict recurrence risks after ATD : ( i ) positive TSHR-Ab ( at the end of ATD treatment ) was significantly associated with a greatly increased recurrence risk ; and ( ii ) despite the relatively small number of patients who were smokers , regular cigarette smoking was shown , for the first time , to be significantly associated with an increased recurrence risk . Also , the deleterious effect of smoking was shown to manifest its impact independently of TSHR-Ab titers at the end of ATD treatment . Thus , compared with the overall 30 % recurrence risk , non-smoking patients with a negative TSHR-Ab ( at the end of ATD ) had a lower ( 18 % ) recurrence risk ; smoking patients with negative TSHR-Ab ( at the end of ATD ) had a 57 % recurrence risk ; non-smoking patients with positive TSHR-Ab ( at the end of ATD ) had a high ( 86 % ) recurrence risk ; the recurrence risk was 100 % in those few patients who both smoked and maintained a positive TSHR-Ab at the end of ATD treatment . CONCLUSIONS The present study confirmed that l-T4 administration during and after ATD withdrawal did not improve remission rate . Two factors , namely positive TSHR-Ab at the end of ATD treatment and regular smoking habits may represent clinical ly useful ( albeit not absolute ) predictors of the risk of recurrence in patients with Graves ' hyperthyroidism treated with ATD . However , due to the relatively small number of smoking patients in the present cohort , this conclusion needs to be confirmed by a larger study CONTEXT Although methimazole ( MMI ) and propylthiouracil ( PTU ) have long been used to treat hyperthyroidism caused by Graves ' disease ( GD ) , there is still no clear conclusion about the choice of drug or appropriate initial doses . OBJECTIVE The aim of the study was to compare the MMI 30 mg/d treatment with the PTU 300 mg/d and MMI 15 mg/d treatment in terms of efficacy and adverse reactions . DESIGN , SETTING , AND PARTICIPANTS Patients newly diagnosed with GD were r and omly assigned to one of the three treatment regimens in a prospect i ve study at four Japanese hospitals . MAIN OUTCOME MEASURES Percentages of patients with normal serum free T(4 ) ( FT4 ) or free T(3 ) ( FT3 ) and frequency of adverse effects were measured at 4 , 8 , and 12 wk . RESULTS MMI 30 mg/d normalized FT4 in more patients than PTU 300 mg/d and MMI 15 mg/d for the whole group ( 240 patients ) at 12 wk ( 96.5 vs. 78.3 % ; P = 0.001 ; and 86.2 % , P = 0.023 , respectively ) . When patients were divided into two groups by initial FT4 , in the group of the patients with severe hyperthyroidism ( FT4 , 7 ng/dl or more , 64 patients ) MMI 30 mg/d
Output:
| The titration ( low dose ) regimen had fewer adverse effects than the block-replace ( high dose ) regimen and was no less effective .
Continued thyroxine treatment following initial antithyroid therapy does not appear to provide any benefit in terms of recurrence of hyperthyroidism . |
MS212468 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE To investigate the set-up errors and deformation associated with daily placement of endorectal balloons in prostate radiotherapy . MATERIAL S AND METHODS Endorectal balloons were placed daily in 20 prostate cancer patients undergoing radiotherapy . Electronic portal images ( EPIs ) were collected weekly from anterior-posterior ( AP ) and lateral views . The EPIs were compared with digitally reconstructed radiographs from computed tomography scans obtained during pretreatment period to estimate displacements . The interfraction deformation of balloon was estimated with variations in diameter in three orthogonal directions throughout the treatment course . RESULTS A total of 154 EPIs were evaluated . The mean displacements of balloon relative to bony l and mark were 1.8 mm in superior-inferior ( SI ) , 1.3 mm in AP , and 0.1 mm in left-right ( LR ) directions . The systematic errors in SI , AP , and LR directions were 3.3 mm , 4.9 mm , and 4.0 mm , respectively . The r and om ( interfraction ) displacements , relative to either bony l and marks or treatment isocenter , were larger in SI direction ( 4.5 mm and 4.5 mm ) , than in AP ( 3.9 mm and 4.4 mm ) and LR directions ( 3.0 mm and 3.0 mm ) . The r and om errors of treatment isocenter to bony l and mark were 2.3 mm , 3.2 mm , and 2.6 mm in SI , AP , and LR directions , respectively . Over the treatment course , balloon deformations of 2.8 mm , 2.5 mm , and 2.6 mm occurred in SI , AP , and LR directions , respectively . The coefficient of variance of deformation was 7.9 % , 4.9 % , and 4.9 % in these directions . CONCLUSIONS Larger interfractional displacement and the most prominent interfractional deformation of endorectal balloon were both in SI direction PURPOSE To evaluate the Vienna Rectoscopy Score ( VRS ) as a feasible and effective tool for detecting and classifying pathologic changes in the rectal mucosa after radiotherapy ( RT ) for prostate cancer , and , also , to correlate its findings with the European Organization for Research and Treatment of Cancer (EORTC)/Radiation Therapy Oncology Group ( RTOG ) score for late rectal toxicity . METHODS AND MATERIAL S A total of 486 patients with localized prostate cancer underwent external-beam RT up to 70 or 74 Gy within an Austrian-German prospect i ve multicenter trial . In 166 patients , voluntary rectal sigmoidoscopy was performed before and at 12 and /or 24 months after RT . Pathologic findings such as telangiectasia , congested mucosa , and ulcers were grade d ( Grade s 0 - 3 ) and summarized according to the VRS . Late rectal side effects ( EORTC/RTOG ) were documented and correlated with the corresponding VRS . RESULTS Before RT , 99 % had a VRS score of 0 . The median follow-up was 40 months . Overall , a late rectal side effects grade or score 1 - 3 was detected in 43 % by EORTC/RTOG compared with 68 % by VRS ( p < 0.05 ) . Grade s 0 , 1 , 2 , and 3 late rectal side effects were found using EORTC/RTOG in 57 % , 11 % , 28 % , and 3 % , respectively ; the corresponding percentages were 32 % , 22 % , 32 % , and 14 % for a VRS of 0 , 1 , 2 , and 3 , respectively . A significant coherence between the VRS and EORTC/RTOG was found ( p < 0.01 ) . CONCLUSIONS The VRS is a feasible and effective tool for describing and classifying pathologic findings in the rectal mucosa after RT within a multicenter trial . The VRS and EORTC/RTOG showed a high coherence . However the VRS was significantly more sensitive A prostate treatment immobilization system was evaluated with respect to setup errors and efficiency for a specific treatment setup . Prostate patients were treated in the prone position with a rectal catheter using the NOMOS intensity modulated radiotherapy system . Immobilization and setup consisted of a Vac‐Lok ™ bag ( MED‐TEC , Orange City , IO ) fitted within a registration carrier box where patients were aligned to the bag using skin marks along the lower leg . Daily setup errors were analyzed using lateral portal films , registration plates mounted to the carrier box , and the pubic symphasis as a bony reference . Two studies were conducted to evaluate setup technique . In the first study , patient setup required 3–5 minutes for patient positioning and the corresponding superior/inferior errors were found to have a st and ard deviation of 3.5 mm . In the second study , the technique st and ards were reduced to allow for faster setup times and , consequently , larger errors ; setup times were 1–2 minutes and the mean and st and ard deviation errors were ~2 and 5 mm , respectively . PACS number(s ) : 87.53.–j , PURPOSE When > 25 % of the rectum is irradiated to > or = 70 Gy , the risk of developing Grade 2 or higher rectal complications is significantly increased . This study evaluates the impact on dose to the rectum from the use of an intrarectal ( IR ) balloon device , previously shown to immobilize the prostate gl and and localize the rectum , in patients receiving dose escalated 3-dimentional ( 3D ) conformal radiation therapy . MATERIAL S AND METHODS From July 2001 through February 2003 , 28 consecutive patients with prostate cancer underwent computerized tomography-based simulation with and without the IR balloon in place . Treatment planning was performed for three clinical paradigms in which the IR balloon was not used at all ( 0 Gy ) , used during the cone-down for 15 treatments ( 28.35 Gy ) , or used for the entire course of 40 treatments ( 75.6 Gy ) . The three plans were compared for differences in the percent of rectum receiving > 70 Gy . RESULTS Dose volume histogram ( DVH ) analysis revealed that the median(range ) of percent rectal volume exceeding 70 Gy was 25 % ( 12.7 - 41.5 % ) , 7.5 % ( 0.9 - 19.5 % ) , and 3.6 % ( 0 - 8.7 % ) for patients in whom the IR balloon was used for 0 , 15 , and 40 treatments , respectively . The percent of rectum exceeding 70 Gy was significantly different for all treatment plan comparisons ( P < 0.0001 ) . CONCLUSIONS Grade 2 or higher rectal toxicity may be minimized during dose escalated 3D conformal radiation therapy through the use of an IR balloon during the 3-week cone down portion of an 8-week treatment course Purpose : Evaluation of late side effects and biochemical control ( bNED ) 5 years after three-dimensional radiotherapy with moderate , risk-adapted dose escalation . Patients and Methods : From 03/1999 to 07/2002 , 486 patients have been registered in the prospect i ve Austrian-German multicenter phase II trial ( AUGE ) . 399 ( 82 % ) localized prostate cancer patients ( T1–3 Nx/N0 M0 ) were evaluated . The low- and intermediate-risk groups were treated with 70 Gy , the high-risk group with 74 Gy , respectively . Additional hormonal therapy ( HT ) was recommended for intermediate- and high-risk group patients . Late toxicity ( EORTC/RTOG ) and bNED ( ASTRO and Phoenix ) were prospect ively assessed . Results : Median follow-up was 65 months . Distribution concerning risk groups ( low- , intermediate- , high-risk group ) showed 29 % , 50 % and 21 % of patients , respectively . HT was given in 87 % of patients . The 5-year actuarial rates of late side effects grade ≥ 2 for 70 Gy/74 Gy were 28%/30 % ( gastrointestinal ; p = 0.73 ) and 19%/34 % ( urogenital ; p = 0,06 ) . The 5-year actuarial bNED rate stratified by risk groups ( low- , intermediate- , high-risk group ) was 74 % , 66 % and 50 % ( ASTRO ) , and 81 % , 80 % and 60 % ( Phoenix ) , respectively . Within multivariate analysis T-stage and initial prostate specific antigen were significant factors influencing bNED ( ASTRO ) whereas Gleason Score and duration of HT were not . Conclusion : Dose escalation within st and ard three-dimensional conformal radiotherapy ( 3D-CRT ) up to a level of 74 Gy did not result in significantly increased gastrointestinal side effects , whereas urogenital side effects showed an increase close to significance . However , the total number of patients with severe toxicity was low . To achieve high tumor control rates with acceptable treatment-related morbidity , local doses of at least 74 Gy should be considered , in particular for intermediate- or high-risk patients applying 3D-CRT.Ziel : Bestimmung von Spätnebenwirkungen und biochemischer Kontrolle ( bNED ) nach risikoadaptierter Dosiseskalation i m Rahmen einer prospektiven österreichisch-deutschen Phase-II-Multicenterstudie . Patienten und Method ik : Von 03/1999 bis 07/2002 wurden 486 Patienten mit Prostatakarzinom ( T1–3 Nx/N0 M0 ) gemeldet , und 399 ( 82 % ) kamen zur Auswertung . Patienten der Niedrig- und Intermediärrisikogruppe wurden mit 70 Gy , die Hochrisikogruppe mit 74 Gy bestrahlt ( Tabelle 1 ) . Eine begleitende Hormontherapie wurde für Patienten der Intermediär- und Hochrisikogruppe empfohlen . Spätnebenwirkungen ( EORTC/RTOG ) und bNED ( ASTRO/Phoenix ) wurden ermittelt . Ergebnisse : Der mittlere Nachbeobachtungszeitraum betrug 65 Monate . Hinsichtlich der Risikogruppen ( Niedrig- , Intermediär- , Hochrisikogruppe ) f and en sich 29 % , 50 % , und 21 % Patienten . Eine begleitende Hormontherapie erhielten 87 % der Patienten . Detaillierte Patienten date n sind in Tabelle 2 aufgeführt . Die 5-Jahres-Raten an Spätnebenwirkungen Grad ≥ 2 für 70 Gy/74 Gy lagen bei 28%/30 % ( gastrointestinal ; p = 0,73 ) und 19%/34 % ( urogenital ; p = 0,06 ; Abbildungen 1 und 2 ) . Die 5-Jahres-bNED-Raten entsprechend den Risikogruppen ( Niedrig- , Intermediär- , Hochrisikogruppe ) lagen bei 74 % , 66 % und 50 % ( ASTRO ; Abbildung 3 ) bzw . 81 % , 80 % und 60 % ( Phoenix ; Abbildung 4 ) . In der multivariaten Analyse zeigten sich T-Stadium und initiales prostataspezifisches Antigen als signifikant bezüglich bNED ( ASTRO ) und Gleason-Score sowie die Dauer der Hormontherapie als nicht signifikant ( Tabelle 4).Schlussfolgerung : Die Dosissteigerung auf 74 Gy führt zu keinen signifikant erhöhten Raten an gastrointestinalen Spätnebenwirkungen . Die Rate an urogenitalen Spätnebenwirkungen ist hingegen erhöht . Insgesamt finden sich jedoch nur wenige schwere Grad-3-Spätnebenwirkungen ( Tabelle 3 ) . Um respektable Tumorkontrollraten ( Abbildung 5 ) zu erreichen , sollte , vor allem für Patienten der Intermediär- und Hochrisikogruppe , eine lokale Dosis von zumindest 74 Gy appliziert werden PURPOSE To assess the benefit of escalating the dose in definitive prostate cancer radiotherapy vs. the associated risk of complications . MATERIAL S AND METHODS Between 1987 and 1999 , 1087 patients with clinical Stage T1b-T3 adenocarcinoma of the prostate were definitively irradiated without hormonal therapy and had a pretreatment serum prostate-specific antigen ( PSA ) and Gleason score recorded . The median follow-up was 65 months . Doses ranged from 64 to 78 Gy , with the treatment techniques corresponding to the year of therapy and the prescribed dose . A total of 301 patients were treated on a r and omized protocol to either 70 or 78 Gy . Also , 163 patients were treated with three-dimensional conformal therapy and had dose-volume histograms available for review . RESULTS Tumor stage , grade , pretreatment PSA level , and radiation dose were all independent predictors of PSA disease-free survival ( PSA-DFS ) in multivariate analysis . The hazard rate for biochemical failure peaked at 1.5 - 3 years after radiotherapy . Although a statistically significant dose effect on PSA-DFS was found in the pretreatment PSA levels of those with both < or = 10 ng/mL
Output:
| RESULTS Overall , ERBs are tolerated well , although patients with pre-existing anorectal disease have an increased risk of developing ERB-related toxicity .
Planning studies show reduced Rwall and anal wall ( Awall ) doses with ERB application .
ERBs seem well-tolerated and in planning studies reduce anorectal wall doses . |
MS212469 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective : To compare the effects of behavioral interventions targeting decreased sedentary behavior versus increased moderate-to-vigorous intensity physical activity ( MVPA ) in older adults . Method : Inactive older adults ( N = 38 , 68 ± 7 years old , 71 % female ) were r and omized to 12-week interventions targeting decreased sedentary behavior ( Sit Less ) or increased MVPA ( Get Active ) . The SenseWear armb and was used to objective ly assess activity in real time . Assessment s included a blinded armb and , the Community Health Activites Model Program for Senior ( CHAMPS ) question naire , 400-meter walk , and the Short Physical Performance Battery ( SPPB ) . Results : Objective ly measured MVPA increased in Get Active ( 75 ± 22 min/week , p < .001 ) ; self-reported MVPA increased in both groups ( p < .05 ) . Sedentary behavior did not change in either group ( all p > .05 ) . Only the Sit Less group improved the SPPB score ( 0.5 ± 0.3 , p = .046 ) . Discussion : Targeting reduced sedentary behavior had a greater effect on physical function among inactive but high functioning older adults over 12 weeks . Future studies of longer duration and combining increased MVPA with reduced sedentary behavior are needed PURPOSE Although moderate-to-vigorous physical activity is related to premature mortality , the relationship between sedentary behaviors and mortality has not been fully explored and may represent a different paradigm than that associated with lack of exercise . We prospect ively examined sitting time and mortality in a representative sample of 17,013 Canadians 18 - 90 yr of age . METHODS Evaluation of daily sitting time ( almost none of the time , one fourth of the time , half of the time , three fourths of the time , almost all of the time ) , leisure time physical activity , smoking status , and alcohol consumption was conducted at baseline . Participants were followed prospect ively for an average of 12.0 yr for the ascertainment of mortality status . RESULTS There were 1832 deaths ( 759 of cardiovascular disease ( CVD ) and 547 of cancer ) during 204,732 person-yr of follow-up . After adjustment for potential confounders , there was a progressively higher risk of mortality across higher levels of sitting time from all causes ( hazard ratios ( HR ) : 1.00 , 1.00 , 1.11 , 1.36 , 1.54 ; P for trend < 0.0001 ) and CVD ( HR:1.00 , 1.01 , 1.22 , 1.47 , 1.54 ; P for trend < 0.0001 ) but not cancer . Similar results were obtained when stratified by sex , age , smoking status , and body mass index . Age-adjusted all-cause mortality rates per 10,000 person-yr of follow-up were 87 , 86 , 105 , 130 , and 161 ( P for trend < 0.0001 ) in physically inactive participants and 75 , 69 , 76 , 98 , 105 ( P for trend = 0.008 ) in active participants across sitting time categories . CONCLUSIONS These data demonstrate a dose-response association between sitting time and mortality from all causes and CVD , independent of leisure time physical activity . In addition to the promotion of moderate-to-vigorous physical activity and a healthy weight , physicians should discourage sitting for extended periods AIM To compare the effect of 7 h of prolonged sitting on resting blood pressure with a similar duration of sitting combined with intermittent brief bouts of light-intensity or moderate-intensity physical activity . METHODS AND RESULTS Overweight/obese adults ( n = 19 ; aged 45 - 65 years ) were recruited for a r and omized three-treatment crossover trial with a one-week washout between treatments : 1 ) uninterrupted sitting ; 2 ) sitting with 2 min bouts of light-intensity walking at 3.2 km/h every 20 min ; and , 3 ) sitting with 2 min bouts of moderate-intensity walking at between 5.8 and 6.4 km/h every 20 min . After an initial 2 h period seated , participants consumed a test meal ( 75 g carbohydrate , 50 g fat ) and completed each condition over the next 5 h. Resting blood pressure was assessed oscillometrically every hour as a single measurement , 5 min prior to each activity bout . GEE models were adjusted for sex , age , BMI , fasting blood pressure and treatment order . After adjustment for potential confounding variables , breaking up prolonged sitting with light and moderate-intensity activity breaks was associated with lower systolic blood pressure [ light : 120 ± 1 mmHg ( estimated marginal mean ± SEM ) , P = 0.002 ; moderate : 121 ± 1 mmHg , P = 0.02 ] , compared to uninterrupted sitting ( 123 ± 1 mmHg ) . Diastolic blood pressure was also significantly lower during both of the activity conditions ( light : 76 ± 1 mmHg , P = 0.006 ; moderate : 77 ± 1 mmHg , P = 0.03 ) compared to uninterrupted sitting ( 79 ± 1 mmHg ) . No significant between-condition differences were observed in mean arterial pressure or heart rate . CONCLUSION Regularly breaking up prolonged sitting may reduce systolic and diastolic blood pressure . TRIAL REGISTRATION NUMBER ACTRN12609000656235 ( http://www.anzctr.org.au ) TRIAL REGISTRATION DATE : August 4th 2009 Background Excessive sitting has been linked to poor health . It is unknown whether reducing total sitting time or increasing brief sit-to-st and transitions is more beneficial . We conducted a r and omized pilot study to assess whether it is feasible for working and non-working older adults to reduce these two different behavioral targets . Methods Thirty adults ( 15 workers and 15 non-workers ) age 50–70 years were r and omized to one of two conditions ( a 2-hour reduction in daily sitting or accumulating 30 additional brief sit-to-st and transitions per day ) . Sitting time , st and ing time , sit-to-st and transitions and stepping were assessed by a thigh worn inclinometer ( activPAL ) . Participants were assessed for 7 days at baseline and followed while the intervention was delivered ( 2 weeks ) . Mixed effects regression analyses adjusted for days within participants , device wear time , and employment status . Time by condition interactions were investigated . Results Recruitment , assessment s , and intervention delivery were feasible . The ‘ reduce sitting ’ group reduced their sitting by two hours , the ‘ increase sit-to-st and ’ group had no change in sitting time ( p < .001 ) . The sit-to-st and transition group increased their sit-to-st and transitions , the sitting group did not ( p < .001 ) . Conclusions This study was the first to demonstrate the feasibility and preliminary efficacy of specific sedentary behavioral goals . Trial Registration clinical trials.gov Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists Background . Overweight and obese older adults have high sedentary time . We tested the feasibility and preliminary effects of a sedentary time reduction intervention among adults over age 60 with a body mass index over 27 kg/m2 using a nonr and omized one-arm design . Methods . Participants ( N = 25 , mean age = 71.4 , mean body mass index = 34 ) completed an 8-week theory-based intervention targeting reduced total sitting time and increased sit-to-st and transitions . An inclinometer ( activPAL ™ ) measured the primary outcomes , change in total sitting time and sit-to-st and transitions . Secondary outcomes included physical activity ( ActiGraph GT3X+ accelerometer ) , self-reported sedentary behaviors , physical function ( Short Physical Performance Battery ) , depressive symptoms ( 8-item Patient Health Question naire ) , quality of life ( PROMIS ) , and study satisfaction . Paired t tests examined pre – post test changes in sitting time , sit-to-st and transitions , and secondary outcomes . Results . Inclinometer measured sitting time decreased by 27 min/day ( p < .05 ) and sit-to-st and transitions increased by 2 per day ( p > .05 ) , while st and ing time increased by 25 min/day ( p < .05 ) . Accelerometer measured sedentary time , light-intensity , and moderate-to-vigorous physical activity improved ( all p values ≤ .05 ) . Self-reported sitting time , gait speed , and depressive symptoms also improved ( all p values < .05 ) . Effect sizes were small . Study satisfaction was high . Conclusions . Reducing sitting time is feasible , and the intervention shows preliminary evidence of effectiveness among older adults with overweight and obesity . R and omized trials of sedentary behavior reduction in overweight and obese older adults , most of whom have multiple chronic conditions , may be promising Older adults represent the segment of the population that sits the most . This study evaluated the feasibility , acceptability , safety , and preliminary efficacy of an intervention to reduce sedentary behavior ( SB ) in older adults that can be disseminated broadly for limited cost and delivered by paraprofessionals with limited training . Senior centers in Central Pennsylvania were r and omized to receive one of two healthy aging programs ( i.e. , intervention or comparison ) . Participants in both groups attended three 90-min meetings over 2 weeks . Behavior change content was delivered at the second session ( i.e. , day 7 ) . Forty-two participants ( nintervention = 25 , ncomparison = 17 ) were recruited from five senior centers . Content for the intervention group focused on reducing SB while comparison group content focused on reducing social isolation . Self-reported SB was assessed on days 7 and 14 . Repeated- measures ANOVA revealed a significant group × time interaction for total and weekday , but not weekend , SB . In the week following the delivery of group content , participants in the intervention group reported an average decrease in total SB of 837.8 min/week ; however , the comparison group reported a nonsignificant average decrease of 263.0 min/week of total SB . Participants in the intervention group also reported an average decrease in weekday SB of 132.6 min/weekday ( d = −0.83 ) in the week following the delivery of group content ; however , the comparison group reported a nonsignificant decrease of 24.0 min/weekday ( d = −0.16 ) . There were no significant changes in weekend SB in either group in the week following the delivery of group content . Participants ’ attendance , measurement completion , and program ratings were high . Safety issues were minimal . This intervention was feasible to implement and evaluate , acceptable to older adults , and showed promise for reducing older adults ’ SB OBJECTIVE To test the safety , feasibility , and effectiveness of reducing sitting time in stroke survivors . DESIGN R and omized controlled trial with attention-matched controls and blinded assessment s. SETTING Community . PARTICIPANTS Stroke survivors ( N=35 ; 22 men ; mean age , 66.9±12.7y ) . INTERVENTIONS Four counseling sessions over 7 weeks with a message of sit less and move more ( intervention group ) or calcium for bone health ( attention-matched control group ) . MAIN OUTCOME MEASURES Measures included safety ( adverse events , increases in pain , spasticity , or fatigue ) and feasibility ( adherence to trial protocol ) . Secondary measures included time spent sitting ( including in prolonged bouts ≥30min ) , st and ing , and stepping as measured by the thigh-worn inclinometer ( 7d , 24h/d protocol ) and time spent in physical activity of at least moderate intensity as measured by a triaxial accelerometer . The Multimedia Activity Recall for Children and Adults was used to describe changes in use of time . RESULTS Thirty-three participants completed the full protocol . Four participants reported falls during the intervention period with no other adverse events . From a baseline average of 640.7±99.6min/d , daily sitting time reduced on average by 30±50.6min/d ( 95 % confidence interval [ CI ] , 5.8 - 54.6 ) in the intervention group and 40.4±92.5min/d in the control group ( 95 % CI , 13.0 - 93.8 ) . Participants in both groups also reduced their time spent in prolong
Output:
| The narrative synthesis suggested that interventions have the potential to reduce sitting time in non-working older adults . |
MS212470 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND As left ventricular assist device ( LVAD ) support duration increases , quality of life ( QoL ) becomes a concern . We review ed the QoL in patients on LVAD support for > or=1 year . METHODS We retrospectively review ed our prospect i ve data base for patients supported > or=1 year by HeartMate pulsatile- ( HM1 ) or continuous-flow ( HM2 ) LVADs from 2000 to 2009 . Transplant or death before 1 year merited exclusion . Metabolic equivalents of tasks ( METs ) , the Minnesota Living with Heart Failure Question naire ( MLHFQ ) , the 6-minute walk distance ( 6MWD ) , and New York Heart Association ( NYHA ) class were review ed . Complications and re-admissions were assessed . RESULTS Thirty patients were supported for > or=1 year ( 7 HM1s , 23 HM2s ) . Mean support duration was 594 + /- 173 days . Mean QoL metrics/functional status indicators at 12 months were : 6MWD , 393 + /- 290 m ; MET tolerance , 3.3 + /- 1 ; MLHFQ , 35 + /- 31 ; and NYHA , 1.4 + /- 0.6 . Mean re-admissions/year was 2.9 + /- 2 , with a duration of 13.8 + /- 21 days . Three patients were never re-admitted . Mean out-of-hospital time was 471 + /- 172 days ( 87.3 % of days ) . Infectious complications led to 43 % of re-admissions and occurred in the : drive-line ( 47 % ) at 442 + /- 236 days ; blood ( 37 % ) at 472 + /- 257 days ; and LVAD pocket ( 20 % ) at 550 + /- 202 days . Twenty-three patients ( 77 % ) required additional operations ( 1.7 + /- 1.8/year ) . The most common indication was drive-line infection , but ranged from ischemic bowel to defibrillator exchange . Eight required LVAD exchanges for mechanical ( n = 4 ) , electrical ( n = 3 ) , and thrombotic ( n = 1 ) issues . CONCLUSIONS Although LVAD support is not without complications , patients spend the majority of time outside the hospital enjoying a good quality of life Background : Capacity to exercise may not be fully restored in patients with heart failure even in the long term after ventricular assist device ( VAD ) implantation . The benefits of exercise training in patients with VAD are unknown . Design and methods : Fifteen patients , aged 38.3 ± 15.9 years , bridged to heart transplantation with left ventricular assist device or biventricular assist device were r and omized at a ratio of 2 : 1 to a training group ( TG , n = 10 ) or a control group ( n = 5 ) , 6.3 ± 4 months after implantation . Both the groups were advised to walk 30–45 min/day . TG also underwent moderate-intensity aerobic exercise using a bike or treadmill for 45 min , three to five times a week , combined with high-intensity inspiratory muscle training using a computer- design ed software to respiratory exhaustion , two to three times a week for 10 weeks . The patients were tested using cardiopulmonary exercise testing , 6-min walk test , spirometry and electronic pressure manometer for inspiratory muscle strength ( Pimax ) and endurance ( sustained Pimax ) measurement . Quality of life was assessed with the Minnesota Living with Heart Failure question naire . Results : TG improved peak oxygen consumption ( 19.3 ± 4.5 vs. 16.8 ± 3.7 ml/kg per min , P = 0.008 ) and VO2 at ventilatory threshold ( 15.1 ± 4.2 vs. 12 ± 5.6 ml/kg per min , P = 0.01 ) , whereas the ventilation/carbon dioxide slope decreased ( 35.9 ± 5.6 vs. 40 ± 6.5 , P = 0.009 ) . The 6-min walk test distance increased ( 527 ± 76 vs. 462 ± 88 m , P = 0.005 ) and quality of life was improved ( 38.2 ± 11.6 vs. 48.9 ± 12.8 , P = 0.005 ) , as well as Pimax ( 131.8 ± 33 vs. 95.5 ± 28cmH2O , P = 0.005 ) , sustained Pimax ( 484 ± 195 vs. 340 ± 193cmH2O/s/10 3 , P = 0.005 ) , and inspiratoty lung capacity ( 2.4 ± 0.9 vs. 1.7 ± 0.7 L , P = 0.008 ) were improved . No significant changes were noted in the control group . Conclusion : Our findings indicate that exercise training may improve the functional status of VAD recipients even at a later period after implantation and thus , may have additional importance in cases of destination therapy OBJECTIVES The authors sought to provide the pre-specified primary endpoint of the ROADMAP ( Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients ) trial at 2 years . BACKGROUND The ROADMAP trial was a prospect i ve nonr and omized observational study of 200 patients ( 97 with a left ventricular assist device [ LVAD ] , 103 on optimal medical management [ OMM ] ) that showed that survival with improved functional status at 1 year was better with LVADs compared with OMM in a patient population of ambulatory New York Heart Association functional class IIIb/IV patients . METHODS The primary composite endpoint was survival on original therapy with improvement in 6-min walk distance ≥75 m. RESULTS Patients receiving LVAD versus OMM had lower baseline health-related quality of life , reduced Seattle Heart Failure Model 1-year survival ( 78 % vs. 84 % ; p = 0.012 ) , and were predominantly INTERMACS ( Interagency Registry for Mechanically Assisted Circulatory Support ) profile 4 ( 65 % vs. 34 % ; p < 0.001 ) versus profiles 5 to 7 . More LVAD patients met the primary endpoint at 2 years : 30 % LVAD versus 12 % OMM ( odds ratio : 3.2 [ 95 % confidence interval : 1.3 to 7.7 ] ; p = 0.012 ) . Survival as treated on original therapy at 2 years was greater for LVAD versus OMM ( 70 ± 5 % vs. 41 ± 5 % ; p < 0.001 ) , but there was no difference in intent-to-treat survival ( 70 ± 5 % vs. 63 ± 5 % ; p = 0.307 ) . In the OMM arm , 23 of 103 ( 22 % ) received delayed LVADs ( 18 within 12 months ; 5 from 12 to 24 months ) . LVAD adverse events declined after year 1 for bleeding ( primarily gastrointestinal ) and arrhythmias . CONCLUSIONS Survival on original therapy with improvement in 6-min walk distance was superior with LVAD compared with OMM at 2 years . Reduction in key adverse events beyond 1 year was observed in the LVAD group . The ROADMAP trial provides risk-benefit information to guide patient- and physician-shared decision making for elective LVAD therapy as a treatment for heart failure . ( Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients [ ROADMAP ] ; NCT01452802 ) BACKGROUND Implantable left ventricular assist devices have benefited patients with end-stage heart failure as a bridge to cardiac transplantation , but their long-term use for the purpose of enhancing survival and the quality of life has not been evaluated . METHODS We r and omly assigned 129 patients with end-stage heart failure who were ineligible for cardiac transplantation to receive a left ventricular assist device ( 68 patients ) or optimal medical management ( 61 ) . All patients had symptoms of New York Heart Association class IV heart failure . RESULTS Kaplan-Meier survival analysis showed a reduction of 48 percent in the risk of death from any cause in the group that received left ventricular assist devices as compared with the medical-therapy group ( relative risk , 0.52 ; 95 percent confidence interval , 0.34 to 0.78 ; P=0.001 ) . The rates of survival at one year were 52 percent in the device group and 25 percent in the medical-therapy group ( P=0.002 ) , and the rates at two years were 23 percent and 8 percent ( P=0.09 ) , respectively . The frequency of serious adverse events in the device group was 2.35 ( 95 percent confidence interval , 1.86 to 2.95 ) times that in the medical-therapy group , with a predominance of infection , bleeding , and malfunction of the device . The quality of life was significantly improved at one year in the device group . CONCLUSIONS The use of a left ventricular assist device in patients with advanced heart failure result ed in a clinical ly meaningful survival benefit and an improved quality of life . A left ventricular assist device is an acceptable alternative therapy in selected patients who are not c and i date s for cardiac transplantation OBJECTIVE Newer generation left ventricular assist devices ( LVADs ) are established for long-term support . The aim of this multi-modal intervention was to improve the body weight , exercise tolerance and psychosocial status in out patients on long-term LVAD support . METHODS Seventy patients participated in this non-r and omized intervention study [ intervention group ( IGr ) n = 34 ; control group ( CGr ) n = 36 ] over 18 months ( T1-T4 ) ; the baseline sample characteristics showed no differences between groups . Dietary counselling and weight management intervention was performed by a dietician based on a specific algorithm . Physical reconditioning followed a home ergometry protocol and was supplemented by psychosocial counselling . The outcomes were measured based on the body mass index ( BMI ) , cardiopulmonary exercise testing and self-report [ hospital anxiety and depression scale ( HADS ) , SF-36 ] . RESULTS The intervention showed a strong positive effect on nutrition and weight management [ 95 % confidence interval ( CI ) : -0.71 - 0.69 ; effect size ( ES ) : 0.907 ; P = 0.02 ) ] , result ing in the normal BMI ( kg/m(2 ) ) values in the IGr ( T1 : 24.0 ± 0.6 ; T4 : 24.5 ± 1.1 ; P = 0.35 ) compared with a significant BMI increase in the CGr ( T1 : 23.8 ± 0.6 ; T4 : 29.7 ± 0.8 ; P = 0.05 ) . Significant differences appeared regarding exercise tolerance ( VO(2)max/% predicted ) in favour of IGr patients ( IGr : 69 ± 2.9 ; CGr 62 ± 3.7 ; P = 0.04 ) . This increase was reflected by patients ' self-reporting based on the SF-36 physical component score ( IGr : P = 0.04 ; CGr : P = 0.54 ) . SF-36 psychosocial component scores showed no changes for both groups . However , CGr showed a tendency for increased anxiety scores relative to their counterparts ( IGr : 4.95 ± 0.4 ; CGr : 6.6 ± 0.9 ; P = 0.03 ) . CONCLUSIONS IGr patients showed a strong benefit from a multi-modal intervention , including dietary counselling , controlled exercise and psychosocial support . Dietary counselling holds potential to prevent obesity in this patient population BACKGROUND Patients with advanced heart failure have improved survival rates and quality of life when treated with implanted pulsatile-flow left ventricular assist devices as compared with medical therapy . New continuous-flow devices are smaller and may be more durable than the pulsatile-flow devices . METHODS In this r and omized trial , we enrolled patients with advanced heart failure who were ineligible for transplantation , in a 2:1 ratio , to undergo implantation of a continuous-flow device ( 134 patients ) or the currently approved pulsatile-flow device ( 66 patients ) . The primary composite end point was , at 2 years , survival free from disabling stroke and reoperation to repair or replace the device . Secondary end points included survival , frequency of adverse events , the quality of life , and functional capacity . RESULTS Preoperative characteristics were similar in the two treatment groups , with a median age of 64 years ( range , 26 to 81 ) , a mean left ventricular ejection fraction of 17 % , and nearly 80 % of patients receiving intravenous inotropic agents . The primary composite end point was achieved in more patients with continuous-flow devices than with pulsatile-flow devices ( 62 of 134 [ 46 % ] vs. 7 of 66 [ 11 % ] ; P<0.001 ; hazard ratio , 0.38 ; 95 % confidence interval , 0.27 to 0.54 ; P<0.001 ) , and patients with continuous-flow devices had superior actuarial survival rates at 2
Output:
| The evidence is currently inadequate to assess the safety and efficacy of exercise-based CR for people with implantable VADs compared with usual care . |
MS212471 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: AIM To investigate the effect of low central venous pressure ( LCVP ) on blood loss during hepatectomy for hepatocellular carcinoma ( HCC ) . METHODS By the method of sealed envelope , 50 HCC patients were r and omized into LCVP group ( n=25 ) and control group ( n=25 ) . In LCVP group , CVP was maintained at 2 - 4 mmHg and systolic blood pressure ( SBP ) above 90 mmHg by manipulation of the patient 's posture and administration of drugs during hepatectomy , while in control group hepatectomy was performed routinely without lowering CVP . The patients ' preoperative conditions , volume of blood loss during hepatectomy , volume of blood transfusion , length of hospital stay , changes in hepatic and renal functions were compared between the two groups . RESULTS There were no significant differences in patients ' preoperative conditions , maximal tumor dimension , pattern of hepatectomy , duration of vascular occlusion , operation time , weight of resected liver tissues , incidence of post-operative complications , hepatic and renal functions between the two groups . LCVP group had a markedly lower volume of total intraoperative blood loss and blood loss during hepatectomy than the control group , being 903.9+/-180.8 mL vs 2 329.4+/-2 538.4 ( W=495.5 , P<0.01 ) and 672.4+/-429.9 mL vs 1 662.6+/-1 932.1 ( W=543.5 , P<0.01 ) . There were no remarkable differences in the pre-resection and post-resection blood losses between the two groups . The length of hospital stay was significantly shortened in LCVP group as compared with the control group , being 16.3+/-6.8 d vs 21.5+/-8.6 d ( W=532.5 , P<0.05 ) . CONCLUSION LCVP is easily achievable in technique . Maintenance of CVP < or= 4 mmHg can help reduce blood loss during hepatectomy , shorten the length of hospital stay , and has no detrimental effects on hepatic or renal function Objective This prospect i ve r and omized study determined the influence of closed-suction drainage on the incidence of postoperative complications after elective hepatic resection . Summary Background Data Routine drainage is no longer advocated after several intra-abdominal surgical procedures . Methods A series of 81 patients who underwent elective hepatic resection were r and omly allocated to either a nondrainage group ( n = 39 ) and a drainage group with closed-suction drainage ( n = 42 ) . Indications for resection were 42 benign lesions and 39 malignant tumors , including 19 with cirrhosis . Major hepatic resection was performed in 25 patients and minor resection , in 56 . All patients underwent ultrasonography with puncture for bacteriologic cultures of all fluid collection s within the first 5 postoperative days . Results One patient died in each group . Ultrasonography found a significantly higher rate of subphrenic collection s in the drainage group compared with the nondrainage group ( respectively , 36 % vs. 15 % , p < 0.05 ) . These collection s were more frequently infected in the drainage group ( n = 6 ) than in the nondrainage group ( n = 2 ) . After major liver resection , the rate of intra-abdominal postoperative complications ( i.e. , subphrenic fluid collection s , hematomas , and bilomas ) was similar between the two groups . Conclusion Minor liver resection is safer without drainage . Major liver resection can be performed with or without abdominal drainage BACKGROUND Two r and omized prospect i ve studies suggested that ischemic preconditioning ( IP ) protects the human liver against ischemia-reperfusion injury after hepatectomy performed under continuous clamping of the portal triad . The primary goal of this study was to determine whether IP protects the human liver against ischemia-reperfusion injury after hepatectomy under continuous vascular exclusion with preservation of the caval flow . STUDY DESIGN Sixty patients were r and omly divided into two groups : with ( n=30 ; preconditioning group ) and without ( n=30 ; control group ) IP ( 10 minutes of portal triad clamping and 10 minutes of reperfusion ) before major hepatectomy under vascular exclusion of the liver preserving the caval flow . Serum concentrations of aspartate transferase , alanine transferase , glutathione-S-transferase , and bilirubin and prothrombin time were regularly determined until discharge and at 1 month . Morbidity and mortality were determined in both groups . RESULTS Peak postoperative concentrations of aspartate transferase were similar in the groups with and without IP ( 851 + /- 1,733 IU/L and 427 + /- 166 IU/L respectively , p=0.2 ) . A similar trend toward a higher peak concentration of alanine transferase and glutathione-S-transferase was indeed observed in the preconditioning group compared with the control group . Morbidity and mortality rates and lengths of ICU and hospitalization stays were similar in both groups . CONCLUSIONS IP does not improve liver tolerance to ischemia-reperfusion after hepatectomy under vascular exclusion of the liver with preservation of the caval flow . This maneuver does not improve postoperative liver function and does not affect morbidity or mortality rates . The clinical use of IP through 10 minutes of warm ischemia in this technique of hepatectomy is not currently recommended OBJECTIVES To analyze sources search ed in Cochrane review s , to determine the proportion of trials included in review s that are indexed in major data bases , and to compare the quality of these trials with those from other sources . METHODS All new systematic review s in the Cochrane Library , Issue1 2001 , that were restricted to r and omized controlled trials ( RCTs ) or quasi- RCTs were selected . The sources search ed in the review s were recorded , and the trials included were checked to see whether they were indexed in four major data bases . Trials not indexed were checked to determine how they could be identified . The quality of trials found in major data bases was compared with those found from other sources . RESULTS The range in the number of data bases search ed per review ranged between one and twenty-seven . The proportion of the trials in the four data bases were Cochrane Controlled Trials Register = 78.5 % , MEDLINE = 68.8 % , Embase = 65.0 % , and Science/Social Sciences Citation Index = 60.7 % . Search ing another twenty-six data bases after Cochrane Controlled Trials Register ( CCTR ) , MEDLINE , and Embase only found 2.4 % additional trials . There was no significant difference between trials found in the CCTR , MEDLINE , and Embase compared with other trials , with respect to adequate allocation concealment or sample size . CONCLUSIONS There was a large variation between review s in the exhaustiveness of the literature search es . CCTR was the single best source of RCTs . Additional data base search ing retrieved only a small percentage of extra trials . Contacting authors and manufacturers to find unpublished trials appeared to be a more effective method of obtaining the additional better quality trials Background / Aims : Degradation of adenine nucleotides to adenosine has been suggested to play a critical role in ischemic preconditioning ( IPC ) . Thus , we question ed in patients undergoing partial hepatectomy whether ( i ) IPC will increase plasma purine catabolites and whether ( ii ) formation of purines in response to vascular clamping ( Pringle maneuver ) can be attenuated by prior IPC . Methods : 75 patients were r and omly assigned to three groups : group I underwent hepatectomy without vascular clamping ; group II was subjected to the Pringle maneuver during resection , and group III was preconditioned ( 10 min ischemia and 10 min reperfusion ) prior to the Pringle maneuver for resection . Central , portal venous and arterial plasma concentrations of adenosine , inosine , hypoxanthine and xanthine were determined by high-performance liquid chromatography . Results : Duration of the Pringle maneuver did not differ between patients with or without IPC . Surgery without vascular clamping had only a minor effect on plasma purine concentrations . After IPC , plasma concentrations of purines transiently increased . After the Pringle maneuver alone , purine plasma concentrations were most increased . This strong rise in plasma purines caused by the Pringle maneuver , however , was significantly attenuated by IPC . When portal venous minus arterial concentration difference was calculated for inosine or hypoxanthine , the respective differences became positive in patients subjected to the Pringle maneuver and were completely prevented by preconditioning . Conclusion : These data demonstrate that ( i ) IPC increases formation of adenosine , and that ( ii ) the unwanted degradation of adenine nucleotides to purines caused by the Pringle maneuver can be attenuated by IPC . Because IPC also induces a decrease of portal venous minus arterial purine plasma concentration differences , IPC might possibly decrease disturbances in the energy metabolism in the intestine as well Objective : To st and ardize the definition of postoperative liver failure ( PLF ) for prediction of early mortality after hepatectomy . Summary Background Data : The definition of PLF is not st and ardized , making the comparison of innovations in surgical techniques and the timely use of specific therapeutic interventions complex . Methods : Between 1998 and 2002 , 775 elective liver resections , including 69 % for malignancies and 60 % major resections , were included in a prospect i ve data base . The nontumorous liver was abnormal in 43 % with steatosis > 30 % in 14 % , noncirrhotic fibrosis in 43 % , and cirrhosis in 12 % . The impact of prothrombin time ( PT ) < 50 % and serum bilirubin ( SB ) > 50 & mgr;mol/L on postoperative days ( POD ) 1 , 3 , 5 , and 7 was analyzed . Results : The lowest PT level was observed on postoperative day ( POD ) 1 , while the peak of SB was observed on POD 3 . These 2 variables tended to return to preoperative values by POD 5 . The median interval between hepatectomy and postoperative death was 15 days ( range , 5–39 days ) . Postoperative mortality significantly increased in patients with PT < 50 % and SB > 50 & mgr;ml/L. The conjunction of PT < 50 % and SB > 50 & mgr;mol/L on POD 5 was a strong predictive factor of mortality . In patients with significant morbidity , this “ 50 - 50 criteria ” was met 3 to 8 days before clinical evidence of complications . Conclusions : The association of PT < 50 % and SB > 50 & mgr;ml/L on POD 5 ( the 50 - 50 criteria ) was a simple , early , and accurate predictor of more than 50 % mortality rate after hepatectomy . This criteria could be identified early enough , before clinical evidence of complications , for specific interventions to be applied in due time BACKGROUND The Pringle manoeuvre and ischaemic preconditioning are applied to prevent blood loss and ischaemia-reperfusion injury , respectively , during liver surgery . In this prospect i ve clinical trial we report on the intraoperative haemodynamic effects of the Pringle manoeuvre alone or in combination with ischaemic preconditioning . METHODS Patients ( n=68 ) were assigned r and omly to three groups : ( i ) resection with the Pringle manoeuvre ; ( ii ) with ischaemic preconditioning before the Pringle manoeuvre for resection ; ( iii ) without pedicle clamping . RESULTS Following the Pringle manoeuvre the mean arterial pressure increased transiently , but significantly decreased after unclamping as a result of peripheral vasodilation . Ischaemic preconditioning improved cardiovascular stability by lowering the need for catecholamines after liver reperfusion without affecting the blood sparing benefits of the Pringle manoeuvre . In addition , ischaemic preconditioning protected against reperfusion-induced tissue injury . CONCLUSIONS Ischaemic preconditioning provides both better intraoperative haemodynamic stability and anti-ischaemic effects thereby allowing us to take full advantage of blood loss reduction by the Pringle manoeuvre HYPOTHESIS Blood loss in hepatic resection is an important determinant of operative outcome . OBJECTIVE To clarify whether reducing the tidal volume would be effective in decreasing blood loss during liver transection . DESIGN R and omized controlled trial . SETTING University hospital . PATIENTS Eighty patients scheduled to undergo hepatic resection were r and omly assigned to receive liver transection under normoventilation ( n = 40 ) or hypoventilation ( n = 40 ) . INTERVENTIONS During liver transection , in the normoventilation group , the tidal volume was 10 mL/kg and the respiratory rate was 10/min ; in the hypoventilation group , the tidal volume was reduced to 4 mL/kg and respiratory rate was increased to 15/min . Liver transection was performed under total or selective inflow occlusion . MAIN OUTCOME MEASURE Blood loss . RESULTS Between the
Output:
| There was no difference in mortality , liver failure , or other morbidities .
The blood loss was significantly lower in vascular occlusion compared with no vascular occlusion .
Intermittent vascular occlusion seems safe in liver resection .
However , it does not seem to decrease morbidity . |
MS212472 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: INTRODUCTION This article illustrates a new treatment method and evaluates the effect of the frequent use of fluori date d chewing sticks ( miswaks ) on the remineralization of white spot lesions ( WSLs ) diagnosed at debonding . METHODS Thirty-seven orthodontic patients ( mean age , 17.2 years ) , with a minimum of 4 WSLs on the buccal surfaces of the maxillary incisors , canines , premolars , and first molars after orthodontic therapy , were enrolled in a double-blind , r and omized , longitudinal trial lasting 6 weeks . The subjects were divided into 2 groups using fluori date d miswaks impregnated in 0.5 % sodium fluoride ( test group , n = 19 ) and nonfluori date d miswaks ( control group , n = 18 ) . A custom-made mouth tray , covering half of the maxillary dentition , was used while brushing with the miswaks 5 times per day . The WSLs were scored by using a DIAGNOdent pen ( KaVo , Biberach , Germany ) and with the International Caries Detection and Assessment System ( ICDAS II ) index , at baseline and 2 , 4 , and 6 weeks after debonding . RESULTS Both the DIAGNOdent readings and the ICDAS II index of the WSLs decreased in the test group on the uncovered side of the dentition but not on the covered side during the 6-week trial ( P < 0.0001 ) . There was also a slight improvement in the control group ( not significant ) . There was a strong correlation between the DIAGNOdent values and the ICDAS II index when all the data were pooled ( P < 0.001 ) . CONCLUSIONS The frequent use of fluori date d miswaks had a remineralizing effect on WSLs . The DIAGNOdent pen might be a useful tool for diagnosing and monitoring changes of WSLs over a relatively short period of time Orthodontic treatment with fixed appliances is considered a risk factor for the development of white spot caries lesions ( WSL ) . Traditionally , brackets are bonded to the buccal surfaces . Lingual brackets are developing rapidly and have become more readily available . Buccal surfaces are considered to be more caries prone than lingual surfaces . Furthermore , lingual brackets are shaped to fit the morphology of the teeth and seal almost the entire surface . In the present study we tested the hypothesis that lingual brackets result in a lower caries incidence than buccal brackets . We tested this hypothesis using a split-mouth design where subjects were allocated r and omly to a group receiving either buccal or lingual brackets on the maxillary teeth and the alternative bracket type in the m and ible . The results indicate that buccal surfaces are more prone to WSL development , especially when WSL existed before treatment . The number of WSL that developed or progressed on buccal surfaces was 4.8 times higher than the number of WSL that developed or progressed on lingual surfaces . When measured using quantitative light-induced fluorescence ( QLF ) , the increase in integrated fluorescence loss was 10.6 times higher buccally than lingually . We conclude that lingual brackets make a difference when caries lesion incidence is concerned Dental caries and result ing tooth decay can produce a multifactorial destructive process with a very high incidence . Cariogenic bacteria attack enamel with acids that produce subsurface lesions , thereby weakening the enamel and allowing bacterial progression into the dentin . The formation of dental decay , because of demineralization of the tooth structure , can be prevented or delayed by increasing the rate of the tooth 's remineralization and replacement relative to the tooth 's rate of demineralization . This rebuilding of enamel may be accelerated by the addition of amorphous calcium phosphate ( ACP ) with the aid of casein phosphopeptide ( CPP ) ( Recaldent molecule ) . In this study , the role of CPP in stabilizing and releasing ACP on the tooth surface has been investigated to better underst and its efficacy in the prevention of tooth demineralization in orthodontic patients . Twenty-five patients who wore fixed orthodontic appliances were enrolled in this clinical trial . It was explained to the patients that CPP-ACP would be used for 3 weeks and then suspended for an additional 3 weeks . Salivary pH evaluation , plaque pH evaluation and oral hygiene index ( OHI ) were performed at T0 , T1 and T2 . Results showed an increase in OHI level and an increase of the salivary pH ( 76 % of the patients ) . Instead of plaque pH level that showed trivial results , only 48 % of the patients showed a bacterial plaque pH increase . In conclusion , this study has not provided unequivocal evidence for the protective properties of Recaldent molecule . Long-term studies are necessary to better underst and the role of this molecule INTRODUCTION Enamel demineralization is a problem in orthodontics . Fluoride is partially effective in addressing this problem , but additional treatment options are needed . The objective of this prospect i ve r and omized controlled trial was to determine the effectiveness of a new product , MI Paste Plus ( GC America , Alsip , Ill ) , in the prevention or reduction of white spot lesions in orthodontic patients . METHODS Sixty patients who were undergoing routine orthodontic treatment were recruited for this prospect i ve r and omized clinical trial . A double-blind method of r and omization was used to determine whether each patient received the MI Paste Plus or a placebo paste ( Tom 's of Maine , Salisbury , United Kingdom ) . Each patient was asked to administer the paste by using a fluoride tray for a minimum of 3 to 5 minutes each day at night after brushing . Photographic records obtained in a light-controlled environment were used to record the presence or absence of white spot lesions in both groups . The enamel decalcification index was used to determine the number of white spot lesions per surface at each time interval . Patients were followed at 4-week intervals for 3 months . A scoring system from 0 to 6 was used to determine the level of caries or cavitations . This system was also used for each tooth at each time interval . RESULTS Fifty patients ( 26 using MI Paste Plus , 24 using the placebo paste ) completed the study . The enamel decalcification index scores for all surfaces were 271 and 135 at the start of treatment and 126 and 258 at the end of treatment for the MI Paste Plus and placebo paste groups , respectively . The enamel decalcification index scores in the MI Paste Plus group reduced by 53.5 % , whereas the placebo group increased by 91.1 % during the study period . A 3-way analysis of variance ( ANOVA ) was done for the average enamel decalcification index scores . The surface type , the product/time interactions , and the product/surface interactions of the mean enamel decalcification index scores were significant ( P < 0.05 ) . CONCLUSIONS MI Paste Plus helped prevent the development of new white spot lesions during orthodontic treatment and decreased the number of white spot lesions already present . The placebo paste had no preventive action on white spot development during orthodontic treatment ; the number of lesions actually increased . MI Paste Plus reduced white spots on the gingival surfaces ; the placebo paste had the opposite effect . The incisal surface effect on the mean enamel decalcification index scores over time and between products was highly significant . The incisal enamel decalcification index scores were consistently higher than those for the other surfaces ( mesial , distal , and gingival ) The aims of this in vitro study were 2‐fold : 1 ) to evaluate two fluorescence methods ( DIAGNOdent and QLF ( quantitative light‐induced fluorescence ) ) for quantification of white spot lesions adjacent to fixed orthodontic appliances ; and 2 ) to determine the inter‐observer agreement of the DIAGNOdent and QLF methods for quantification of incipient enamel lesions adjacent to fixed orthodontic appliances . Forty‐one premolar teeth with visually sound smooth surfaces or visually white spot enamel lesions were included in the study . Orthodontic brackets were fixed adjacent to the lesions , thus simulating the position of fixed appliances during orthodontic treatment . All teeth were measured using both the DIAGNOdent and QLF methods . Of the 41 teeth , 20 smooth surfaces were r and omly selected and analyzed by 4 operators using both DIAGNOdent and QLF . The teeth were sectioned into 300‐μm‐thick slices using a water‐cooled diamond saw and the slices manually ground to 80–100 μm thickness . Histopathology and transverse microradiography were performed to provide the gold st and ards for verification of lesion depth and mineral loss , respectively . The Spearman rank correlation coefficients between lesion depth determined by histopathology and the DIAGNOdent and QLF were 0.76 and 0.82 , respectively , whereas the Pearson correlation coefficients between mineral loss and the two methods were 0.64 and 0.84 , respectively . Inter‐observer agreement was found to be 0.80 and 0.93 for DIAGNOdent and QLF , respectively . In conclusion , QLF may be a suitable method for quantifying incipient carious lesions adjacent to fixed orthodontic appliances This study investigated , using digital bitewing radiography , the progression and regression of approximal caries in adolescent subjects chewing a sugar-free gum containing 54 mg CPP-ACP relative to the identical gum without CPP-ACP . 2,720 subjects from 29 schools were r and omly assigned to one of the two gums and were instructed to chew their assigned gum for 3 × 10 min/day , with one session supervised on school days , over the 24-month study period . St and ardized digital bitewing radiographs were taken at the baseline and 24-month clinical examinations for each subject . The radiographs , scored by a single examiner , were assessed for approximal surface dental caries at both the enamel and dentine level . Surface level transitions were scored using a transition matrix . Caries progression or regression was analysed using proportional-odds ordered logistic regression modelling of the transition scores at the tooth surface level . There was a statistically significant difference in the frequency distributions of the transition scores between the two gum groups ( OR = 0.82 , p = 0.03 ) . For subjects chewing the CPP-ACP gum the odds of a surface experiencing caries progression were 18 % less than those of a surface experiencing caries progression for subjects chewing the control gum . In conclusion , the 54 mg CPP-ACP sugar-free gum significantly slowed progression and enhanced regression of approximal caries relative to a control sugar-free gum in a 24-month clinical trial BACKGROUND Remineralization process is accelerated by the presence of fluoride ions in the oral environment , but this mechanism of caries reversal will be further enhanced if the concentration of calcium , phosphate and fluoride ions is supersaturated with respect to that of oral fluids . AIM This in vivo study was carried out to evaluate and compare the remineralizing efficacy of a urea-based mineral-enriched mouthrinse and a fluori date d dentifrice using an in vivo intraoral appliance model and polarized light microscopic evaluation technique . MATERIAL S AND METHODS The specimens were prepared from sound teeth and artificial caries was produced using an artificial caries medium in vitro and enamel specimens were inserted in removable orthodontic appliances that were to be worn by 14 children of 10 - 15 years of age . They were divided into three groups - nonfluori date d dentifrice , fluori date d dentifrice and mineral-enriched mouthrinse groups . After the 6-month experimental period , during which the enamel specimens inserted in the intraoral appliance were subjected to one of the agents ( either fluoride , nonfluoride dentifrice or mouthrinse ) in vivo , the specimens were retrieved from the patients and were evaluated using the polarized light microscopic technique . OBSERVATIONS AND RESULTS On analysis , mineral gain occurred in all groups , viz . nonfluoride dentifrice group , fluoride dentifrice and mineral-enriched mouthrinse group . However , it was found to be complete in the mouthrinse group , i.e. both at the surface and at the subsurface ( 67 % ) , while in the fluori date d dentifrice group , 43 % of the sample s showed mineral gain in both zones . In the nonfluori date d dentifrice group also , remineralization occurred but was limited either to the surface or the subsurface zone . CONCLUSIONS Urea-based mineral-enriched mouthrinse was shown to be more efficacious in the process of remineralization of artificial carious lesions BACKGROUND The anticariogenic potential of casein phosphopeptide-amorphous calcium phosphate nanocomplexes ( CPP-ACP ) has been demonstrated using laboratory , animal and human in situ caries models . The aim of this study was to determine the effect of CPP-ACP incorporation into a sugar-free lozenge ( pressed mint tablet ) on enamel remineralization in a human in situ model . METHODS The study utilized a double-blind , r and omized , cross-over design with four treatments : ( i ) a lozenge containing 56.4 mg ( 3 per cent w/w ) CPP-ACP ; ( ii ) a lozenge containing 18.8 mg ( 1 per cent w/w ) CPP-ACP ; ( iii ) a lozenge not containing CPP-ACP ; and ( iv ) a no lozenge nil-treatment control . Ten subjects wore removable palatal appliances with four , human-enamel , half-slab insets containing subsurface lesions . Lozenges were consumed , without chewing , four times per day for 14 days duration . After each treatment period the enamel slabs were removed , paired with their
Output:
| Based on the literature , there is a lack of reliable evidence to support the effectiveness of remineralizing agents for the treatment of postorthodontic white spot lesions |
MS212473 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Low-dose CT screening is recommended for individuals at high risk of developing lung cancer . However , CT screening does not detect all lung cancers : some might be missed at screening , and others can develop in the interval between screens . The NELSON trial is a r and omised trial to assess the effect of screening with increasing screening intervals on lung cancer mortality . In this prespecified analysis , we aim ed to assess screening test performance , and the epidemiological , radiological , and clinical characteristics of interval cancers in NELSON trial participants assigned to the screening group . METHODS Eligible participants in the NELSON trial were those aged 50 - 75 years , who had smoked 15 or more cigarettes per day for more than 25 years or ten or more cigarettes for more than 30 years , and were still smoking or had quit less than 10 years ago . We included all participants assigned to the screening group who had attended at least one round of screening . Screening test results were based on volumetry using a two-step approach . Initially , screening test results were classified as negative , indeterminate , or positive based on nodule presence and volume . Subsequently , participants with an initial indeterminate result underwent follow-up screening to classify their final screening test result as negative or positive , based on nodule volume doubling time . We obtained information about all lung cancer diagnoses made during the first three rounds of screening , plus an additional 2 years of follow-up from the national cancer registry . We determined epidemiological , radiological , participant , and tumour characteristics by reassessing medical files , screening CTs , and clinical CTs . The NELSON trial is registered at www.trialregister.nl , number IS RCT N63545820 . FINDINGS 15,822 participants were enrolled in the NELSON trial , of whom 7915 were assigned to low-dose CT screening with increasing interval between screens , and 7907 to no screening . We included 7155 participants in our study , with median follow-up of 8·16 years ( IQR 7·56 - 8·56 ) . 187 ( 3 % ) of 7155 screened participants were diagnosed with 196 screen-detected lung cancers , and another 34 ( < 1 % ; 19 [ 56 % ] in the first year after screening , and 15 [ 44 % ] in the second year after screening ) were diagnosed with 35 interval cancers . For the three screening rounds combined , with a 2-year follow-up , sensitivity was 84·6 % ( 95 % CI 79·6 - 89·2 ) , specificity was 98·6 % ( 95 % CI 98·5 - 98·8 ) , positive predictive value was 40·4 % ( 95 % CI 35·9 - 44·7 ) , and negative predictive value was 99·8 % ( 95 % CI 99·8 - 99·9 ) . Retrospective assessment of the last screening CT and clinical CT in 34 patients with interval cancer showed that interval cancers were not visible in 12 ( 35 % ) cases . In the remaining cases , cancers were visible when retrospectively assessed , but were not diagnosed because of radiological detection and interpretation errors ( 17 [ 50 % ] ) , misclassification by the protocol ( two [ 6 % ] ) , participant non-compliance ( two [ 6 % ] ) , and non-adherence to protocol ( one [ 3 % ] ) . Compared with screen-detected cancers , interval cancers were diagnosed at more advanced stages ( 29 [ 83 % ] of 35 interval cancers vs 44 [ 22 % ] of 196 screen-detected cancers diagnosed in stage III or IV ; p<0·0001 ) , were more often small-cell carcinomas ( seven [ 20 % ] vs eight [ 4 % ] ; p=0·003 ) and less often adenocarcinomas ( nine [ 26 % ] vs 102 [ 52 % ] ; p=0·005 ) . INTERPRETATION Lung cancer screening in the NELSON trial yielded high specificity and sensitivity , with only a small number of interval cancers . The results of this study could be used to improve screening algorithms , and reduce the number of missed cancers . FUNDING Zorgonderzoek Nederl and Medische Wetenschappen and Koningin Wilhelmina Fonds BACKGROUND The aggressive and heterogeneous nature of lung cancer has thwarted efforts to reduce mortality from this cancer through the use of screening . The advent of low-dose helical computed tomography ( CT ) altered the l and scape of lung-cancer screening , with studies indicating that low-dose CT detects many tumors at early stages . The National Lung Screening Trial ( NLST ) was conducted to determine whether screening with low-dose CT could reduce mortality from lung cancer . METHODS From August 2002 through April 2004 , we enrolled 53,454 persons at high risk for lung cancer at 33 U.S. medical centers . Participants were r and omly assigned to undergo three annual screenings with either low-dose CT ( 26,722 participants ) or single-view posteroanterior chest radiography ( 26,732 ) . Data were collected on cases of lung cancer and deaths from lung cancer that occurred through December 31 , 2009 . RESULTS The rate of adherence to screening was more than 90 % . The rate of positive screening tests was 24.2 % with low-dose CT and 6.9 % with radiography over all three rounds . A total of 96.4 % of the positive screening results in the low-dose CT group and 94.5 % in the radiography group were false positive results . The incidence of lung cancer was 645 cases per 100,000 person-years ( 1060 cancers ) in the low-dose CT group , as compared with 572 cases per 100,000 person-years ( 941 cancers ) in the radiography group ( rate ratio , 1.13 ; 95 % confidence interval [ CI ] , 1.03 to 1.23 ) . There were 247 deaths from lung cancer per 100,000 person-years in the low-dose CT group and 309 deaths per 100,000 person-years in the radiography group , representing a relative reduction in mortality from lung cancer with low-dose CT screening of 20.0 % ( 95 % CI , 6.8 to 26.7 ; P=0.004 ) . The rate of death from any cause was reduced in the low-dose CT group , as compared with the radiography group , by 6.7 % ( 95 % CI , 1.2 to 13.6 ; P=0.02 ) . CONCLUSIONS Screening with the use of low-dose CT reduces mortality from lung cancer . ( Funded by the National Cancer Institute ; National Lung Screening Trial Clinical Trials.gov number , NCT00047385 . ) BACKGROUND The Mayo Lung Project ( MLP ) was a r and omized , controlled clinical trial of lung cancer screening that was conducted in 9211 male smokers between 1971 and 1983 . The intervention arm was offered chest x-ray and sputum cytology every 4 months for 6 years ; the usual-care arm was advised at trial entry to receive the same tests annually . No lung cancer mortality benefit was evident at the end of the study . We have extended follow-up through 1996 . METHODS A National Death Index-PLUS search was used to assign vital status and date and cause of death for 6523 participants with unknown information . The median survival for lung cancer patients diagnosed before July 1 , 1983 , was calculated by use of Kaplan-Meier estimates . Survival curves were compared with the log-rank test . RESULTS The median follow-up time was 20.5 years . Lung cancer mortality was 4.4 ( 95 % confidence interval [ CI ] = 3.9 - 4.9 ) deaths per 1000 person-years in the intervention arm and 3.9 ( 95 % CI = 3.5 - 4.4 ) in the usual-care arm ( two-sided P : for difference = .09 ) . For participants diagnosed with lung cancer before July 1 , 1983 , survival was better in the intervention arm ( two-sided P : = .0039 ) . The median survival for patients with resected early-stage disease was 16.0 years in the intervention arm versus 5.0 years in the usual-care arm . CONCLUSIONS Extended follow-up of MLP participants did not reveal a lung cancer mortality reduction for the intervention arm . Similar mortality but better survival for individuals in the intervention arm indicates that some lesions with limited clinical relevance may have been identified in the intervention arm RATIONALE Screening for lung cancer with modern imaging technology may decrease lung cancer mortality , but encouraging results have only been obtained in uncontrolled studies . OBJECTIVES To explore the effect of screening with low-dose spiral computed tomography ( LDCT ) on lung cancer mortality . Secondary endpoints are incidence , stage at diagnosis , and resectability . METHODS Male subjects , aged 60 to 75 years , smokers of 20 or more pack-years , were r and omized to screening with LDCT or control groups . All participants underwent a baseline , once-only chest X-ray and sputum cytology examination . Screening-arm subjects had LDCT upon accrual to be repeated every year for 4 years , whereas controls had a yearly medical examination only . MEASUREMENTS AND MAIN RESULTS A total of 2,811 subjects were r and omized and 2,472 were enrolled ( LDCT , 1,276 ; control , 1,196 ) . After a median follow-up of 33 months , lung cancer was detected in 60 ( 4.7 % ) patients receiving LDCT and 34 ( 2.8 % ) control subjects ( P = 0.016 ) . Resectability rates were similar in both groups . More patients with stage I disease were detected by LDCT ( 54 vs. 34 % ; P = 0.06 ) and fewer cases were detected in the screening arm due to intercurrent symptoms . However , the number of advanced lung cancer cases was the same as in the control arm . Twenty patients in the LDCT group ( 1.6 % ) and 20 controls ( 1.7 % ) died of lung cancer , whereas 26 and 25 died of other causes , respectively . CONCLUSIONS The mortality benefit from lung cancer screening by LDCT might be far smaller than anticipated Purpose Low-dose multislice-CT ( MSCT ) detects many early-stage lung cancers with good prognosis , but whether it decreases lung cancer mortality and at which costs is yet insufficiently explored . Scope of the present study is to examine within a common European effort whether MSCT screening is capable to reduce the lung cancer mortality by at least 20 % and at which amount of undesired side effects this could be achieved . Methods Overall 4,052 heavy smoking men and women were recruited by a population -based approach and r and omized into a screening arm with five annual MSCT screens and an initial quit-smoking counseling , and a control arm with initial quit-smoking counseling and five annual question naire inquiries . Results In the first screening round , 2,029 participants received a MSCT providing 1,488 negative and 540 suspicious screens with early recalls ( early recall rate 26.6 % ) leading to 31 biopsies ( biopsy rate 1.5 % ) and 22 confirmed lung cancers ( detection rate 1.1 % ) . Among the lung cancers , 15 were adenocarcinomas , 3 squamous cell carcinomas , one small-cell lung cancer , and 3 others , whereby 18 were in clinical stage I , one in stage II , and 3 in stage III . One interval cancer occurred . Conclusions The indicated performance indicators fit into the range observed in comparable trials . The study continues finalizing the second screening round and for the first participants even the last screening round . The unresolved issue of the precise amount of side effects and the high early recall rate precludes currently the recommendation of MSCT as screening tool for lung cancer In a r and omized prospect i ve study of lung cancer detection in a high-risk population of over 6000 heavy smokers semiannual screening by X-ray and sputum cytology was compared to screening at a 3-year interval . The comparison of Kaplan-Meier estimates of survival curves done without and with correcting for lead-time bias disclosed a rather important impact of lead-time bias on survival comparisons . On the contrary , controlling for possible length bias had no obvious effect on the shape of survival curves . The evaluation of mortality from lung cancer , being used as a basic criterion , indicated no traceable benefit from semiannual screening . The higher incidence of lung cancer in the frequently screened group was paralleled by a higher mortality . It is concluded that currently available screening techniques will not solve the problem of lung cancer mortality in smokers . The results underline the importance of primary prevention for lung cancer The study was launched in the mid‐1970s to explore the capability of screening by chest X‐ray and sputum cytology to be used as an effective component of the lung cancer control program in the Czech Republic , a Central European country with a high and increasing occurrence of lung cancer in men at that time . A complementary objective of this report is to ascertain whether the cumulative numbers of lung cancer deaths would equalize in the two r and omized groups during a prolonged follow‐up period THE R AND OMIZED controlled trial ( RCT ) , more than any other methodology , can have a powerful and immediate impact on patient care . Ideally , the report of such an evaluation needs to convey to the reader relevant information
Output:
| There was a statistically non-significant increase in all-cause mortality .
The results showed that in terms of lung cancer mortality reduction LDCT was ranked as the best screening strategy , CXR screening as the worst strategy and usual care intermediate . |
MS212474 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Patients receiving oral anticoagulation ( OAC ) who undergo drug-eluting stent ( DES ) implantation require additional dual antiplatelet therapy with aspirin and clopidogrel . Such triple therapy confers an elevated bleeding risk , and its optimal duration is not known . OBJECTIVES The goal of this study was to evaluate whether shortening the duration of clopidogrel therapy from 6 months to 6 weeks after DES implantation was associated with a superior net clinical outcome in patients receiving concomitant aspirin and OAC . METHODS In this r and omized , open-label trial , we enrolled patients receiving OAC who underwent DES implantation at 3 European centers between September 2008 and December 2013 . A total of 614 patients receiving concomitant aspirin and OAC were r and omized to either 6-week clopidogrel therapy ( n=307 ) or 6-month clopidogrel therapy ( n=307 ) . The primary endpoint was a composite of death , myocardial infa rct ion ( MI ) , definite stent thrombosis , stroke , or Thrombolysis In Myocardial Infa rct ion ( TIMI ) major bleeding at 9 months . RESULTS The primary endpoint occurred in 30 patients ( 9.8 % ) in the 6-week group compared with 27 patients ( 8.8 % ) in the 6-month group ( hazard ratio [ HR ] : 1.14 ; 95 % CI : 0.68 to 1.91 ; p=0.63 ) . There were no significant differences for the secondary combined ischemic endpoint of cardiac death , MI , definite stent thrombosis , and ischemic stroke ( 12 [ 4.0 % ] vs. 13 [ 4.3 % ] ; HR : 0.93 ; 95 % CI : 0.43 to 2.05 ; p=0.87 ) or the secondary bleeding endpoint of TIMI major bleeding ( 16 [ 5.3 % ] vs. 12 [ 4.0 % ] ; HR : 1.35 ; 95 % CI : 0.64 to 2.84 ; p=0.44 ) . CONCLUSIONS Six weeks of triple therapy was not superior to 6 months with respect to net clinical outcomes . These results suggest that physicians should weigh the trade-off between ischemic and bleeding risk when choosing the shorter or longer duration of triple therapy . ( Triple Therapy in Patients on Oral Anticoagulation After Drug Eluting Stent Implantation [ ISAR-TRIPLE ] ; NCT00776633 ) BACKGROUND Oral anticoagulation ( OAC ) is the recommended therapy for patients with atrial fibrillation ( AF ) because it reduces the risk of stroke and other thromboembolic events . Dual antiplatelet therapy ( DAPT ) is required after percutaneous coronary intervention and stenting ( PCI-S ) . In patients with AF requiring PCI-S , the association of DAPT and OAC carries an increased risk of bleeding , whereas OAC therapy or DAPT alone may not protect against the risk of developing new ischemic or thromboembolic events . OBJECTIVE The MUSICA-2 study will test the hypothesis that DAPT compared with triple therapy ( TT ) in patients with nonvalvular AF at low-to-moderate risk of stroke ( CHADS2 score ≤2 ) after PCI-S reduces the risk of bleeding and is not inferior to TT for preventing thromboembolic complications . DESIGN The MUSICA-2 is a multicenter , open-label r and omized trial that will compare TT with DAPT in patients with AF and CHADS2 score ≤2 undergoing PCI-S. The primary end point is the incidence of stroke or any systemic embolism or major adverse cardiac events : death , myocardial infa rct ion , stent thrombosis , or target vessel revascularization at 1 year of PCI-S. The secondary end point is the combination of any cardiovascular event with major or minor bleeding at 1 year of PCI-S. The calculated sample size is 304 patients . CONCLUSIONS The MUSICA-2 will attempt to determine the most effective and safe treatment in patients with nonvalvular AF and CHADS2 score ≤2 after PCI-S. Restricting TT for AF patients at high risk for stroke may reduce the incidence of bleeding without increasing the risk of thromboembolic complications Most evidence regarding the efficacy and safety of the antithrombotic regimens for patients with atrial fibrillation ( AF ) undergoing percutaneous coronary intervention with stent ( PCI‐S ) derives from small , single‐center , retrospective data sets . To obtain further data on this issue , we carried out the prospect i ve , multicenter , observational Management of patients with Atrial Fibrillation undergoing Coronary Artery Stenting ( AFCAS ) registry ( Clinical trials.gov identifier NCT00596570 ) Background Chronic atrial fibrillation ( AF ) , coexisting with a history of recent coronary angioplasty with stent ( PCI-S ) , represents an encoded indication for oral anticoagulation ( OAC ) with warfarin plus dual antiplatelet therapy ( DAPT ) . Methods Using a retrospective cohort study , we determined the respective impacts on cardiovascular outcomes of three different pharmacologic regimens , i.e. , triple therapy ( TT ) with warfarin + clopidogrel and aspirin , dual therapy ( DT ) with warfarin + clopidogrel or aspirin , and DAPT with clopidogrel + aspirin . Outcomes of interest were all-cause mortality , ischemic cardiac events , ischemic cerebral events , and bleeding events . The inclusion criterion was the coexistence of an indication for OAC ( e.g. , chronic AF ) with an indication for DAPT due to recent PCI-S. Results Among the 98 patients enrolled , 48 ( 49 % ) , 31 ( 31.6 % ) , and 19 ( 19.4 % ) patients were prescribed TT , DT , and DAPT , respectively . Throughout a mean follow-up of 378 ± 15.7 days , there were no significant differences between the three regimens for all abovementioned outcomes . In particular , the total frequency of major bleeding was similar in the three groups : five cases ( 10.4 % ) in TT , one case ( 3.22 % ) in DT and no case in DAPT groups ( Chi-square test , P = 0.1987 ) . Conclusions TT , DT and DAPT displayed similar efficacy and safety . Although the superiority of OAC vs. DAPT for stroke prevention in AF patients has been demonstrated by previous r and omized trials , a smaller frequency of high thromboembolic risks ’ features in DAPT group of the present study may have prevented the observation of a higher incidence of ischemic stroke in this group BACKGROUND The effects of dual antiplatelet therapy ( DAPT ) and triple therapy ( TT : DAPT plus oral anticoagulation ) in patients with atrial fibrillation ( AF ) undergoing percutaneous coronary intervention ( PCI ) regarding to CHA2DS2-VASc score remain undefined . We compare the effect of TT vs. DAPT in this setting regarding the CHA2DS2-VASc score . METHODS AND RESULTS In a prospect i ve multicenter registry , 585 patients ( 75.2 % male , 73.2 ± 8.2 years ) with AF undergoing PCI were followed up during 1 year . Of them , 157 ( 26.8 % ) had a CHA2DS2-VASc=1 , and 428 ( 73.2 % ) had a CHA2DS2-VASc ≥2 . TT was prescribed in 51.6 % with CHA2DS2-VASc=1 and in 55.5 % with CHA2DS2-VASc ≥ 2 . Patients with CHA2DS2-VASc=1 receiving TT had a similar thromboembolism rate to those on DAPT ( 1.2 % vs. 1.3 % , P=0.73 ) , but more total ( 19.5 % vs. 6.9 % , P=0.01 ) and a tendency to more major ( 4.9 % vs. 0 % , P=0.06 ) bleeding . However , patients with CHA2DS2-VASc ≥ 2 receiving TT had a lower thromboembolism rate ( 1.7 % vs. 5.3 % , P=0.03 ) and a trend towards more bleeds ( 21.8 % vs. 15.6 % , P=0.06 ) , with an excess of major bleeding ( 8.4 % vs. 3.1 % , P=0.01 ) . Rates of major adverse cardiac events ( MACE ) in both CHA2DS2-VASc subgroups were similar , irrespective of treatment . In a Cox multivariate analysis , TT was associated to major bleeding , but not with MACE . CONCLUSIONS In patients with AF and CHA2DS2-VASc=1 undergoing PCI , the use of TT involves a high risk of bleeding without a significant benefit in preventing thromboembolism Objectives : To identify the therapeutic regimens used at discharge in patients receiving oral anticoagulant therapy ( OAT ) who undergo stenting percutaneous coronary intervention and stent implantation ( PCI-S ) , and to assess the safety and efficacy associated with different therapeutic regimens according to thromboembolic risk . Design : A prospect i ve multicentre registry . Setting : In hospital , after discharge and follow-up by telephone call . Patients and methods : 405 patients ( 328 male/77 female ; mean ( SD ) age 71 ( 9 ) years ) receiving OAT who underwent PCI-S between November 2003 and June 2006 from nine catheterisation laboratories of tertiary care teaching hospitals in Spain and one in the United Kingdom were included . Results : Three therapeutic regimens were identified at discharge : triple therapy (TT)—that is , any anticoagulant ( AC ) plus double antiplatelet therapy ( DAT ; 278 patients ( 68.6 % ) ; AC and a single antiplatelet ( AC+AT ; 46 ( 11.4 % ) ) and DAT only ( 81 ( 20 % ) ) . At 6 months , patients receiving TT showed the greatest rate of bleeding events . No patients receiving DAT at low thromboembolic risk presented a bleeding event ( 14.8 % receiving TT , 11.8 % receiving AC+AT and 0 % receiving DAT , p = 0.033 ) or cardiovascular event ( 6.7 % receiving TT , 0 % receiving AC+AT and 0 % receiving DAT , p = 0.126 ) . The combination of AC+AT showed the worst rate of adverse events in the whole cohort , especially in patients at moderate – high thromboembolic risk . Conclusions : In patients receiving OAT , TT was the most commonly used regimen after PCI-S. DAT was associated with the lowest rate of bleeding events and a similar efficacy to TT in patients at low thromboembolic risk . TT should probably be restricted to patients at moderate – high thromboembolic risk BACKGROUND The optimal antithrombotic strategy for patients with atrial fibrillation ( AF ) undergoing drug-eluting stent ( DES ) implantation is unknown . METHODS AND RESULTS The 622 consecutive AF patients undergoing DES implantation were prospect ively enrolled . Among them , 142 patients ( TT group ) continued triple antithrombotic therapy comprising aspirin , clopidogrel and warfarin after discharge ; 355 patients ( DT group ) had dual antiplatelet therapy ; 125 patients ( WS group ) were discharged with warfarin and a single antiplatelet agent . Target INR was set as 1.8 - 2.5 and was regularly monitored after discharge . The TT group had a significant reduction in stroke and major adverse cardiac and cerebral events ( MACCE ) ( 8.8 % vs 20.1 % vs 14.9 % , P=0.010 ) as compared with either the DT or WS group . In the Cox regression analysis , administration with warfarin ( hazard ratio ( HR ) 0.49 ; 95 % confidence interval ( CI ) 0.31 - 0.77 ; P=0.002 ) and baseline CHADS(2 ) score > or=2 ( HR 2.09 ; 95%CI 1.27 - 3.45 ; P=0.004 ) were independent predictors of MACCE . Importantly , the incidence of major bleeding was comparable among 3 groups ( 2.9 % vs 1.8 % vs 2.5 % , P=0.725 ) , although the overall bleeding rate was increased in the TT group . Kaplan-Meier analysis indicated that the TT group was associated with the best net clinical outcome . CONCLUSIONS The cardiovascular benefits of triple antithrombotic therapy were confirmed by reducing the MACCE rate , and its major bleeding risk might be acceptable if the INR is closely monitored Current recommendations for the antithrombotic management of patients receiving oral anticoagulation ( OAC ) who undergo percutaneous coronary intervention with stent implantation ( PCI-S ) are based on limited and relatively weak data . To broaden and strengthen available evidence , the management and 1-year outcomes of OAC patients who underwent PCI-S and were included in a prospect i ve , multicenter registry from
Output:
| Conclusions For patients requiring OAC after coronary intervention , OAC plus clopidogrel may bring more clinical net benefit than TT , whereas OAC plus aspirin should be the last choice . |
MS212475 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: OBJECTIVE To assess Ohio obstetrician/gynecologists ' perceptions and use of the 5As method of smoking cessation ( ask , advise , assess , assist , and arrange ) with pregnant patients who smoke . METHODS A three-wave mailing procedure was used with a statewide r and om sample of obstetrician/ gynecologists who responded to a valid and reliable 31-item question naire . RESULTS Regarding the 5As method of smoking cessation , almost all ( 98 % ) asked their pregnant patients about smoking , but fewer respondents engaged in advising ( 66 % ) , assessing ( 42 % ) , assisting ( 29 % ) , and arranging for follow-up visits or referrals ( 6 % ) . Higher efficacy expectations were associated with greater use of the 5As method ( r = 0.52 , p < 0.001 ) . A majority believed that two cessation activities would result in smoking cessation in pregnant smokers : explaining the dangers of smoking ( 65 % ) and referring pregnant smokers to smoking cessation programs ( 57 % ) . However , 26 % of physicians reported that they were " slightly confident " or " not confident at all " in their ability to refer pregnant smokers to such programs , and 6 % of physicians reported always providing smoking cessation referrals . A significant proportion of respondents believed that prenatal smoking would not cause severe effects for the unborn child but would likely lead to moderate ( 46 % ) or minor ( 3 % ) health effects . CONCLUSION Obstetrician/gynecologists face many competing dem and s for their time and energy , yet 62 % believed smoking cessation advice would be of significant value . Physicians with higher levels of efficacy expectations reported significantly greater use of the 5 As . Future research should explore ways to facilitate obstetrician/gynecologists ' use of the 5As method OBJECTIVE To compare the implementation , delivery , and implication s for dissemination of 2 different maternal smoking-cessation/relapse-prevention interventions in managed care environments . STUDY DESIGN Healthy Options for Pregnancy and Parenting ( HOPP ) was a r and omized , controlled efficacy trial of an intervention that bypassed the clinical setting . Stop Tobacco for OuR Kids ( STORK ) was a quasi-experimental effectiveness study of a point-of-service intervention . Both incorporated prenatal and postnatal components . PATIENTS AND METHODS Subjects in both studies were pregnant women who either smoked currently or had quit recently . The major intervention in HOPP was telephone counseling delivered by trained counselors , whereas the STORK intervention was delivered by providers and staff during prepartum , inpatient postpartum , and well-baby visits . RESULTS In HOPP , 97 % of telephone intervention participants reported receiving 1 or more counselor calls . The intervention delayed but did not prevent postpartum relapse to smoking . Problems with intervention delivery related primarily to identification of the target population and acceptance of repeated calls . STORK delivered 1 or more cessation contacts to 91 % of prenatal smokers in year 1 , but the rate of intervention delivery declined in years 2 and 3 . Modest differences were obtained in sustained abstinence between 6 and 12 months postpartum , but not in point prevalence abstinence at 12 months . CONCLUSIONS The projects were compared using 4 of the 5 dimensions of the RE- AIM model including reach , adoption , implementation , and maintenance . It was difficult to apply the fifth dimension , efficacy , because of the differences in study design and purpose of the interventions . The strengths and limitations of each project were identified , and it was concluded that a combined intervention that incorporates elements of both HOPP and STORK would be optimal if it could be implemented at reasonable cost Antenatal clinic staff were surveyed for their attitudes to smoking in pregnancy in 1993 and again in 1996 to monitor the effect of a r and omised controlled trial of a smoking intervention conducted in the clinic over the period . Descriptive analysis showed that staff believe smoking in pregnancy is an important health risk for both mother and baby , quitting smoking is difficult , counselling is only moderately successful , they lack the skill to counsel smokers and there is little time to do so . The lack of structural support within clinic administration , the lack of a comprehensive hospital policy on smoking and unclear public health messages , were also identified as barriers to reducing the prevalence of smoking This study investigated the impact of a behaviorally based intervention design ed to increase the number of hospitals that routinely provide effective smoking cessation programs for pregnant women . In Queensl and , Australia , 70 publicly funded hospitals were matched on numbers of births and maternal socioeconomic status and r and omly allocated to an awareness-only intervention group or a behaviorally based intervention group . Success was defined as the routine offer of an evidence -based smoking cessation program to at least 80 % of the pregnant clients who smoke . At 1 month , 65 % of the behaviorally based intervention hospitals agreed to provide material s about smoking cessation programs for their antenatal patients , compared with 3 % of the awarenessonly hospitals . After 1 year , 43 % of the intervention hospitals still provided the material , compared with 9 % of the awareness-only hospitals . These findings showthat a brief intervention to hospitals can encourage antenatal staff to provide smoking cessation material s to pregnant women Background African American women are at increased risk for poor pregnancy outcomes compared to other racial-ethnic groups . Single or multiple psychosocial and behavioral factors may contribute to this risk . Most interventions focus on singular risks . This paper describes the design , implementation , challenges faced , and acceptability of a behavioral counseling intervention for low income , pregnant African American women which integrated multiple targeted risks into a multi-component format . Methods Six academic institutions in Washington , DC collaborated in the development of a community-wide , primary care research study , DC-HOPE , to improve pregnancy outcomes . Cigarette smoking , environmental tobacco smoke exposure , depression and intimate partner violence were the four risks targeted because of their adverse impact on pregnancy . Evidence -based models for addressing each risk were adapted and integrated into a multiple risk behavior intervention format . Pregnant women attending six urban prenatal clinics were screened for eligibility and risks and r and omized to intervention or usual care . The 10-session intervention was delivered in conjunction with prenatal and postpartum care visits . Descriptive statistics on risk factor distributions , intervention attendance and length ( i.e. , with < 4 sessions considered minimal adherence ) for all enrolled women ( n = 1,044 ) , and perceptions of study participation from a sub- sample of those enrolled ( n = 152 ) are reported . Results Forty-eight percent of women screened were eligible based on presence of targeted risks , 76 % of those eligible were enrolled , and 79 % of those enrolled were retained postpartum . Most women reported a single risk factor ( 61 % ) ; 39 % had multiple risks . Eighty-four percent of intervention women attended at least one session ( 60 % attended ≥ 4 sessions ) without disruption of clinic scheduling . Specific risk factor content was delivered as prescribed in 80 % or more of the sessions ; 78 % of sessions were fully completed ( where all required risk content was covered ) . Ninety-three percent of the sub sample of intervention women had a positive view of their relationship with their counselor . Most intervention women found the session content helpful . Implementation challenges of addressing multiple risk behaviors are discussed . Conclusion While implementation adjustments and flexibility are necessary , multiple risk behavioral interventions can be implemented in a prenatal care setting without significant disruption of services , and with a majority of referred African American women participating in and expressing satisfaction with treatment sessions OBJECTIVE To explore the midwife 's role in providing education and support for changes in smoking behaviour during usual primary maternity care . DESIGN A qualitative study using a thematic approach to analysis of data collected in face-to-face interviews . SETTING AND PARTICIPANTS Eleven women who had participated in the intervention groups of the MEWS Study , a cluster r and omised trial of education and support for women who smoke , and 16 midwives from the intervention and control arms of the trial . The trial was set in the lower North Isl and of New Zeal and in 2000 . FINDINGS Midwives acknowledged that asking women about smoking was part of their role as maternity care providers . However , many found it difficult to know how to ask women about their smoking , how to identify the women who would be receptive to advice and how to support them to make changes to their smoking . Midwives were also concerned about making women feel guiltier than they already did about their smoking , and about the impact of providing smoking cessation on their relationship with women . In contrast , women expected their midwife to ask them about their smoking . When women wanted to quit their midwife was an extremely valuable source of information and support . Midwives were also in a position to help women who did not want to quit to make other changes to their smoking behaviour . Even women who did not want to quit were prepared to be asked about their smoking . Problems arose when the way the midwife asked and the frequency of her enquiries were not appropriate for the stage of the change cycle the woman was in . IMPLICATION S FOR PRACTICE Midwives can effectively provide education and support for smoking change during pregnancy if they match the woman 's readiness to make changes with the type of advice and support they provide
Output:
| These were whether or not the subject of smoking is broached by a health professional , the content of advice and information provided , the manner of communication , having service protocol s , follow-up discussion , staff confidence in their skills , the impact of time and re source constraints , staff perceptions of ineffectiveness , differences between professionals , and obstacles to accessing interventions .
DISCUSSION The findings suggest variation in practice between services and different professional groups , in particular regarding the recommendation of quitting smoking versus cutting down but also in regard to procedural aspects , such as recording status and repeat advice giving .
These differences offer the potential for a pregnant woman to receive contradicting advice . |
MS212476 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: BACKGROUND Bodily pain and physical disability can negatively impact health-related quality of life ( HRQL ) in patients with osteoarthritis ( OA ) . OBJECTIVE To assess the effects of treatment with a new agent , rofecoxib , on HRQL in patients with OA . STUDY DESIGN R and omized , double-blind , 6-week clinical trial comparing treatment with rofecoxib , 5 to 50 mg , with placebo in 672 patients with OA of the hip or knee . MAIN OUTCOME MEASURE Patient HRQL was assessed at baseline and at the end of treatment using the Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) . RESULTS At 6 weeks , mean change from baseline in all SF-36 mental and physical health domain scores demonstrated significant improvement with rofecoxib use ( P < .05 for all doses for all SF-36 domains ) , with evidence of a dose-response relation . Improvements in mental and physical HRQL domains with rofecoxib treatment were significantly greater than those with placebo treatment ( P < .05 for each dose of rofecoxib vs placebo for all domains except general health ) and highly correlated with improvements observed using disease-specific OA outcome measures such as the Western Ontario and McMaster Universities Osteoarthritis Index-visual Analog 3.0 OA index pain and physical function subscales . The effect of rofecoxib vs placebo treatment on mental health largely disappeared after adjustment for improvement in OA disease-specific measures . CONCLUSIONS Rofecoxib treatment increased physical and mental HRQL domain scores on the SF-36 . Improvements in mental health with rofecoxib use primarily result ed from effective treatment of OA ( i.e. , reduction in pain and improvement in physical function ) BACKGROUND Acetaminophen ( paracetamol ) is recommended as the initial pharmacological treatment for knee or hip osteoarthritis . However , survey and clinical trial data indicate greater efficacy for non-steroidal anti-inflammatory drugs and cyclo-oxygenase-2 specific inhibitors . DESIGN Two r and omised , double blind , placebo controlled , crossover multicentre clinical trials , Patient Preference for Placebo , Acetaminophen or Celecoxib Efficacy Studies ( PACES ) . PATIENTS Osteoarthritis of knee or hip . INTERVENTION " Wash out " of treatment ; r and omisation ; 6 weeks of celecoxib 200 mg/day , acetaminophen 1000 mg four times a day , or placebo ; second " wash out ; " crossover to 6 weeks of second treatment . MEASUREMENTS Western Ontario McMaster Osteoarthritis Index ( WOMAC ) , visual analogue pain scale , patient preference between two treatments . RESULTS Celecoxib was more efficacious than acetaminophen in both periods in both studies ; WOMAC and pain scale scores differed at p<0.05 in period II and both periods combined of PACES-a and in periods I and II and both periods combined in PACES-b , but not in period I of PACES-a . Acetaminophen was more efficacious than placebo , generally p<0.05 in PACES-b , and > 0.05 in PACES-a . Patient preferences were 53 % celecoxib v 24 % acetaminophen in PACES-a ( p<0.001 ) and 50 % v 32 % in PACES-b ( p = 0.009 ) ; 37 % acetaminophen v 28 % placebo in PACES-a ( p = 0.340 ) and 48 % v 24 % in PACES-b ( p = 0.007 ) . No clinical ly or statistically significant differences were seen in adverse events or tolerability among the three treatment groups . CONCLUSIONS Greater efficacy was seen for celecoxib v acetaminophen v placebo , while adverse events and tolerability were similar . Variation in results and statistical significance in the two different trials are of interest Background — Although r and omized trials of cyclooxygenase-2 ( COX-2 ) inhibitors have shown increased cardiovascular risk , studies of nonselective , nonsteroidal antiinflammatory drugs ( NSAIDs ) and acetaminophen have been inconsistent . Methods and Results — We examined the influence of NSAIDs and acetaminophen on the risk of major cardiovascular events ( nonfatal myocardial infa rct ion , fatal coronary heart disease , nonfatal and fatal stroke ) in a prospect i ve cohort of 70 971 women , aged 44 to 69 years at baseline , free of known cardiovascular disease or cancer , who provided medication data biennially since 1990 . During 12 years of follow-up , we confirmed 2041 major cardiovascular events . Women who reported occasional ( 1 to 21 d/mo ) use of NSAIDs or acetaminophen did not experience a significant increase in the risk of cardiovascular events . However , after adjustment for cardiovascular risk factors , women who frequently ( ≥22 d/mo ) used NSAIDs had a relative risk ( RR ) for a cardiovascular event of 1.44 ( 95 % CI , 1.27 to 1.65 ) compared with nonusers , whereas those who frequently consumed acetaminophen had a RR of 1.35 ( 95 % CI , 1.14 to 1.59 ) . The elevated risk associated with frequent NSAID use was particularly evident among current smokers ( RR=1.82 ; 95 % CI , 1.38 to 2.42 ) and was absent among never smokers ( Pinteraction=0.02 ) . Moreover , we observed significant dose-response relations : Compared with nonusers , the RRs for a cardiovascular event among women who used ≥15 tablets per week were 1.86 ( 95 % CI , 1.27 to 2.73 ) for NSAIDs and 1.68 ( 95 % CI , 1.10 to 2.58 ) for acetaminophen . Conclusions — Use of NSAIDs or acetaminophen at high frequency or dose is associated with a significantly increased risk for major cardiovascular events , although more moderate use did not confer substantial risk OBJECTIVE This multicentre , r and omized , double-blind , placebo-controlled parallel-group study was undertaken to investigate the efficacy , safety and tolerability of lumiracoxib ( Prexige ) , a cyclooxygenase-2 selective inhibitor , in patients with primary osteoarthritis ( OA ) of the h and . METHODS The study r and omized 594 patients aged > or = 18 years with symptomatic OA of the h and . Patients underwent a 3 to 7-day washout for previous nonsteroidal anti-inflammatory drugs and those with pain intensity > or = 40 mm on a 100 mm Visual Analogue Scale ( VAS ) in the target h and during the 24 hours prior to baseline and an increase in pain intensity of either > or = 20 % or > or = 10 mm VAS since screening ( whichever was greater ) were r and omized to lumiracoxib 200 mg once daily ( od ) ( n=205 ) , lumiracoxib 400 mg od ( n=193 ) or placebo ( n=196 ) . The primary efficacy variable was overall OA pain intensity ( VAS mm ) in the target h and after 4 weeks of treatment . Safety and tolerability assessment s were performed . RESULTS After 4 weeks of treatment , overall OA pain intensity in the target h and was significantly lower for patients treated with lumiracoxib compared with patients treated with placebo ( both doses p<0.001 ) . There was no significant difference between lumiracoxib doses in terms of the reduction in overall OA pain intensity . Lumiracoxib was well tolerated . The incidence of adverse events was similar for active treatment groups and placebo . CONCLUSIONS Lumiracoxib 200 and 400 mg od were effective and well tolerated treatments for OA of the h and . Lumiracoxib significantly improved overall OA pain intensity in the target h and versus placebo , with a tolerability profile similar to placebo Background Etoricoxib is a highly selective COX-2 inhibitor which was evaluated for the treatment of rheumatoid arthritis ( RA ) . Methods Double-blind , r and omized , placebo and active comparator-controlled , 12-week study conducted at 67 sites in 28 countries . Eligible patients were chronic NSAID users who demonstrated a clinical worsening of arthritis upon withdrawal of pre study NSAIDs . Patients received either placebo , etoricoxib 90 mg once daily , or naproxen 500 mg twice daily ( 2:2:1 allocation ratio ) . Primary efficacy measures included direct assessment of arthritis by counts of tender and swollen joints , and patient and investigator global assessment s of disease activity . Key secondary measures included the Stanford Health Assessment Question naire , patient global assessment of pain , and the percentage of patients who achieved ACR20 responder criteria response ( a composite of pain , inflammation , function , and global assessment s ) . Tolerability was assessed by adverse events and routine laboratory evaluations . Results 1171 patients were screened , 891 patients were r and omized ( N = 357 for placebo , N = 353 for etoricoxib , and N = 181 for naproxen ) , and 687 completed 12 weeks of treatment ( N = 242 for placebo , N = 294 for etoricoxib , and N = 151 for naproxen ) . Compared with patients receiving placebo , patients receiving etoricoxib and naproxen showed significant improvements in all efficacy endpoints ( p<0.05 ) . Treatment responses were similar between the etoricoxib and naproxen groups for all endpoints . The percentage of patients who achieved ACR20 responder criteria response was 41 % in the placebo group , 59 % in the etoricoxib group , and 58 % in the naproxen group . Etoricoxib and naproxen were both generally well tolerated . Conclusions In this study , etoricoxib 90 mg once daily was more effective than placebo and similar in efficacy to naproxen 500 mg twice daily for treating patients with RA over 12 weeks . Etoricoxib 90 mg was generally well tolerated in RA patients SUMMARY Objective : To evaluate and compare the efficacy and tolerability of etoricoxib and diclofenac in patients with osteoarthritis of the knee or hip . Methods : In this 6-week double-blind , active comparator controlled , parallel-group study eligible osteoarthritis patients were r and omised to receive either etoricoxib 60 mg once daily ( n = 256 ) or diclofenac 50 mg three times daily ( n = 260 ) . The primary study endpoint was the Western Ontario McMaster osteoarthritis index ( WOMAC ) pain subscale . Other endpoints included were the WOMAC stiffness and physical function subscales , and the Patient 's Global Assessment of Response to Therapy ( PGART ) question naire . Early efficacy was evaluated using WOMAC first question ( pain walking on a flat surface ) and PGART 4 h after the morning dose of each drug on days 1 and 2 . Rescue medication ( paracetamol ) used was also recorded . The study was design ed to show comparable efficacy between etoricoxib 60 mg once daily and diclofenac 50 mg three times daily with respect to the primary endpoint and was conducted outside the United States at 67 centres in 29 countries . Results : Etoricoxib ( 60 mg once daily ) was comparable in efficacy to diclofenac ( 150 mg daily ) on all the above parameters . The one exception was in the assessment of early efficacy where etoricoxib demonstrated significantly greater benefit within 4 h of taking the first dose on the first day of therapy ( p = 0.007 ) as evaluated by the percentage of patients with good or excellent ( PGART ) responses . The treatment effects of both drugs were similar by the time day 2 was reached and were sustained throughout the 6 weeks of therapy . Both treatments were generally well tolerated . Conclusions : Etoricoxib is clinical ly effective in the therapy of osteoarthritis providing a magnitude of effect comparable to that of the maximum recommended daily dose of diclofenac . The onset of clinical benefit with etoricoxib on day one is more rapid than that of diclofenac . Both drugs were generally well tolerated OBJECTIVE To compare the efficacy of the cyclooxygenase 2 (COX-2)-specific inhibitors celecoxib and rofecoxib in treating the signs and symptoms of osteoarthritis ( OA ) . METHODS In this r and omized , placebo-controlled , double-blind , multicenter study , 475 patients with OA of the knee received either celecoxib 200 mg/day ( n = 189 ) , rofecoxib 25 mg/day ( n = 190 ) , or placebo ( n = 96 ) for 6 weeks . Arthritis assessment s were performed at baseline , week 3 , and week 6 ( or at the time of early termination ) . RESULTS In primary measures of efficacy ( OA pain score on a 100-mm visual analog scale [ VAS ] and total domain score on the Western Ontario and McMaster Universities Osteoarthritis Index ) , celecoxib
Output:
| The overall risk of MI with NSAIDs and cyclo-oxygenase-2-specific drugs was small ; rofecoxib showed the highest risk .
There was an increased MI risk with cyclo-oxygenase-2-specific drugs compared with NSAIDs , but less serious upper gastrointestinal toxicity |
MS212477 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: PURPOSE To identify prognostic clinical and treatment related factors for local control , distant metastasis-free survival , and survival by means of a multivariate analysis in patients with advanced squamous cell carcinoma of the head and neck after concomitant boost radiochemotherapy . PATIENTS AND METHODS From 1992 to 1995 , 68 patients with squamous cell cancer of the head and neck ( 93 % stage IV disease ) were treated with a simultaneous radiochemotherapy with Carboplatin using a concomitant boost technique . The total tumor volume ( TTV ) was quantitatively determined based on computed tomography scans in 56 patients . A Cox proportional hazards regression analysis was performed for each of the above endpoints and statistical significance of the Cox models was verified using the likelihood ratio test and Bonferroni correction for multiple testing . RESULTS The survival and locoregional control rates at three years were 35 and 32 % . The multivariate analysis revealed a significant association between the TTV and survival ( P = 0.0008 ) and between the pretreatment serum hemoglobin concentration and locoregional control ( P = 0.01 ) and survival ( P = 0.05 ) . The locoregional control was significantly associated with the N-stage ( P = 0.007 ) and there was a good correlation between the N-stage and TTV in this study population . CONCLUSION Our data corroborate the prognostic relevance of the tumor volume and hemoglobin concentration . In studies comparing the survival of patients with advanced cancer of the head and neck , the use of the TTV as a covariable may improve the statistical power In trial no. 22811 on a r and omized comparison of multiple fractions per day ( MFD ) , with or without misonidazole , to conventional fractionation in advanced head and neck cancer , a large number ( 523 ) of patients was entered in a short period of time . No differences in treatment results were obtained , but the study created an important data base , allowing for detailed evaluation of the most important factors influencing prognosis . In univariate analysis , factors significantly influencing survival and locoregional control were : performance status , histological differentiation , tumor site , tumor and nodal staging , and tumoral and nodal volume . In multivariate analysis , significant factors for survival were nodal involvement , tumor stage , performance status , and tumor site . Significant factors for locoregional control were nodal involvement and total tumor burden . This analysis suggests that total tumor burden ( volume ) should be included in the interpretation of treatment results in head and neck cancer Purpose : Tumor volume after the lymph node involvement is one of the most important single prognostic factor in patients of head and neck cancers treated with radiotherapy . We have recently demonstrated that the hypoxic subvolume is more important than the total tumor volume . We therefore propose the hypothesis that the presence of visible necrosis might be an important factor for cure by radiotherapy in squamous cell cancers of the head and neck . Methods : A total of 51 patients with locally advanced inoperable ( T3 - 4 or N2 - 3 ) squamous cell cancers of the head and neck ( mean age 57 years , range 41–75 years ) were prospect ively investigated with regard to a possible impact of tumor volume . All patients received CT examination of the head and neck according to a st and ardized protocol ( spiral CT , contrast enhancement after automatic injection ) , and the total tumor volume was calculated as the sum of volumes of all visible macroscopic tumor sites . Poorly perfused and necrotic areas ( no contrast enhancement ) within macroscopic tumor sites were also calculated . Patients were then treated with accelerated-hyperfractionated radiotherapy in about 6 weeks . Seventeen patients were treated with only radiation . Patients without contraindications to cisplatin chemotherapy received cisplatin chemotherapy or a combination of cisplatin and paclitaxel ( N=34 ) . The allocation of patients to certain treatment regimens was based on individual decisions in each case and not r and omized . Results : In patients treated with radiation alone , 12/17 ( 71 % ) got recurrence whereas in patients treated with radiation plus cisplatin , only 14/34 ( 41 % ) recurred ( P=0.05 ) . The 2-year overall survival was for radiation alone versus radiation plus cisplatin 0 % vs. 62 % ( P<0.0008 ) . Tumors with smaller amount of necrosis ( necrosis volume<4 cm3 ) had a good prognosis irrespective of type of treatment ( radiation alone or radiation plus cisplatin ) . However , patients with tumors with a larger amount of necrosis ( necrosis volume≥4 cm3 ) had a significantly better outcome if they were treated with radiation plus cisplatin as compared to patients treated with radiation alone . In a multi-variate analysis using a Cox-regression model the type of treatment ( radiotherapy plus versus without cisplatin ) was the only independent prognostic factor for event-free survival ( P<0.03 ) in the whole group . Conclusions : In this non-r and omized retrospective investigation with limited sample size , radiation plus cisplatin was superior to radiation alone . This result ed mainly from a higher efficacy of the radiochemotherapy regimen in patients with large and especially necrotic tumors . The prognostic and predictive impact of visible necrosis should be further evaluated PURPOSE To determine whether the immunohistochemical expression of proliferation-associated antigens ( proliferating cell nuclear antigen , MIB1 ) and the nuclear p53 reactivity in addition to total tumor volume , nodal CT density and T and N category are predictive for overall survival and locoregional tumor control in patients with squamous cell carcinoma of the head and neck region . MATERIAL S AND METHODS Between October 1989 and September 1993 , 87 patients with biopsy proven head and neck cancer were r and omly allocated to receive radiation alone or simultaneous radiation and chemotherapy as part of a multicenter trial with a total of 298 r and omized patients . There were only inoperable lesions in UICC ( 1992 ) stage III ( 8 % ) and IV ( 92 % ) . Radiotherapy was delivered with 180 cGy twice daily up to a total dose of 7020 cGy in 51 days . Three cycles of 2340 cGy each were separated by a rest period of 11 days . Chemotherapy consisted of cis-DDP , 5-fluorouracil and leucovorin and was repeated on days 22 and 44 . Routinely-processed paraffin-embedded sections were stained using monoclonal antibodies for detection of proliferation-associated antigens ( MIB1 and PCNA ) and p53 oncoprotein to determine the labeling index ( LI ) . In addition , the total tumor volume and the percentage of necrosis were measured using CT data . The median follow-up was 3.9 years ( range 1.9 - 5.0 years ) . RESULTS The overall survival and locoregional control for all 87 patients were 34 and 39 % at 3 years , respectively . The addition of chemotherapy result ed in a better overall survival ( 27 versus 47 % , P = 0.03 ) but did not influence locoregional control ( 31 versus 47 % , P = 0.08 ) . In univariate analysis , nodal CT density ( P < 0.0001 ) , total tumor volume ( P < 0.0001 ) , age ( P = 0.001 ) and the MIB1-LI ( P = 0.04 ) had a significant impact on overall survival . However , in the final Cox model only the nodal CT density ( P = 0.0003 ) and age ( P = 0.05 ) were independent prognostic factors for survival and only the nodal CT density ( P = 0.0006 ) was an independent prognostic factor for locoregional control . The expression of the p53 oncoprotein was not found to have a clear predictive value . CONCLUSION Nodal CT density , total tumor volume and age will remain the relevant prognostic factors in stage III/IV head and neck cancer The imaging and analysis protocol of the UK multicentre study of magnetic resonance imaging ( MRI ) as a method of screening for breast cancer in women at genetic risk is described . The study will compare the sensitivity and specificity of contrast-enhanced MRI with two-view x-ray mammography . Approximately 500 women below the age of 50 at high genetic risk of breast cancer will be recruited per year for three years , with annual MRI and x-ray mammography continuing for up to 5 years . A symptomatic cohort will be measured in the first year to ensure consistent reporting between centres . The MRI examination comprises a high-sensitivity three-dimensional contrast-enhanced assessment , followed by a high-specificity contrast-enhanced study in equivocal cases . Multiparametric analysis will encompass morphological assessment , the kinetics of contrast agent uptake and determination of quantitative pharmacokinetic parameters . Retrospective analysis will identify the most specific indicators of malignancy . Sensitivity and specificity , together with diagnostic performance , diagnostic impact and therapeutic impact will be assessed with reference to pathology , follow-up and changes in diagnostic certainty and therapeutic decisions . Mammography , lesion localisation , pathology and cytology will be performed in accordance with the UK NHS Breast Screening Programme quality assurance st and ards . Similar st and ards of quality assurance will be applied for MR measurements and evaluation PURPOSE To investigate the value of CT-derived tumor parameters as predictor of local and regional outcome of tonsillar squamous cell carcinoma treated by definitive radiation therapy . METHODS AND MATERIAL S The pretreatment CT studies of 112 patients with tonsillar squamous cell carcinoma were review ed . After redigitizing the films , primary and nodal tumor volume was calculated with the summation-of- areas technique . The nodal CT aspect was grade d using a 3-point scale ( homogenous , inhomogeneous , and necrotic ) . Mean follow-up time was 33 months . Actuarial statistical analysis of local and regional outcome was done for each of the covariates ; multivariate analysis was performed using Cox 's proportional hazards model . RESULTS In the actuarial analysis , CT-determined primary tumor volume was significantly correlated with local recurrence rate ( p < 0.05 ) when all patients were considered , but primary tumor volume did not predict local control within the T2 , T3 , and T4 category . CT-determined nodal volume was significantly related to regional outcome ( p < 0.01 ) , but nodal density was not . Total tumor volume was not significantly related to locoregional outcome ( p = 0.1 ) . In the multivariate analysis , the T and N categories were the independent predictors of local and regional outcomes , respectively . CONCLUSION Compared to other head- and -neck sites , primary and nodal tumor volume have only marginal predictive value regarding local and regional outcome after radiation therapy in tonsillar cancer PURPOSE Tumor volume ( TV ) is one of the main reported factors determining the outcome of treatment in head- and -neck carcinomas . In this study , the prognostic impact of TV was explored in the context of a r and omized trial with the patients assigned to receive st and ard radiotherapy ( RT ) alone or RT plus platinum compounds ( RT alone , RT plus cisplatin , or RT plus carboplatin ) . METHODS AND MATERIAL S The tumor outlines were traced and digitized on each pretreatment CT slice for each of the 101 patients studied . Taking into account the magnification factor of the scan and CT slice thickness , a computer with specifically design ed software calculated the TV in cubic centimeters . RESULTS The median overall survival for the whole group of patients was 21.6 months ( 95 % confidence interval , 13.0 - 30.2 ) and the 3-year survival rate was 40 % . The addition of platinum compounds to RT ( Groups 2 and 3 ) significantly improved the survival rate ( RT alone vs. RT plus cisplatin , hazard ratio 0.36 , p = 0.002 ; RT alone vs. RT plus carboplatin , hazard ratio 0.53 , p = 0.029 ) . In univariate analysis , the most significant parameters for survival were treatment group , total gross tumor volume ( TGTV ) , complete response , nodal GTV , primary GTV , and performance status . In multivariate analysis , treatment group , TGTV , gender , and primary site were independent prognostic factors for survival . A prognostic threshold of 22.8 cm(3 ) was detected for TGTV . Patients with a TGTV of < 22.8 cm(3 ) were more likely to achieve a complete response and had a median survival of 45.3 months , and those with a TGTV > 22.8 cm(3 ) had a median survival of 12.3 months ( log-rank test , p = 0.0102 ) . CONCLUSION The prognostic significance of the TGTV was confirmed and a cutoff value of 22.8 cm(3 ) derived . Our data indicated that locally advanced head- and -neck carcinomas should not be treated by st and ard ( once-daily ) RT alone . Tumor size and disease subsite should be taken into account in future r and omized trials to increase their statistical power OBJECTIVES /HYPOTHESIS Just as tumor volume is a prognostic indicator for local disease control among patients with head and neck cancer of intermediate size treated with radiation therapy , we hypothesized a similar association for patients with advanced disease treated with chemoradiation therapy . STUDY DESIGN Retrospective analysis of primary and nodal tumor volume was correlated with prospect ively
Output:
| Until now , there 's no clear statistical evidence for the use of either TTV or nodal volume versus primary tumor volume to predict the individual loco-regional control or survival after treatment . |
MS212478 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Despite similar morphological aspects , anaplastic oligodendroglial tumors ( AOTs ) form a heterogeneous clinical subgroup of gliomas . The chromosome arms 1p/19q codeletion has been shown to be a relevant biomarker in AOTs and to be perfectly exclusive from EGFR amplification in gliomas . To identify new genomic regions associated with prognosis , 60 AOTs from the EORTC trial 26951 were analyzed retrospectively using BAC-array-based comparative genomic hybridization . The data were processed using a binary tree method . Thirty-three BACs with prognostic value were identified distinguishing four genomic subgroups of AOTs with different prognosis ( p < 0.0001 ) . Type I tumors ( 25 % ) were characterized by : ( 1 ) an EGFR amplification , ( 2 ) a poor prognosis , ( 3 ) a higher rate of necrosis , and ( 4 ) an older age of patients . Type II tumors ( 21.7 % ) had : ( 1 ) loss of prognostic BACs located on 1p tightly associated with 19q deletion , ( 2 ) a longer survival , ( 3 ) an oligodendroglioma phenotype , and ( 4 ) a frontal location in brain . Type III AOTs ( 11.7 % ) exhibited : ( 1 ) a deletion of prognostic BACs located on 21q , and ( 2 ) a short survival . Finally , type IV tumors ( 41.7 % ) had different genomic patterns and prognosis than type I , II and III AOTs . Multivariate analysis showed that genomic type provides additional prognostic data to clinical , imaging and pathological features . Similar results were obtained in the cohort of 45 central ly review ed – vali date d cases of AOTs . Whole genome analysis appears useful to screen the numerous genomic abnormalities observed in AOTs and to propose new biomarkers particularly in the non-1p/19q codeleted AOTs PURPOSE This is one of a few studies that have explored the value of baseline symptoms and health-related quality of life ( HRQOL ) in predicting survival in patients with brain cancer . PATIENTS AND METHODS Baseline HRQOL scores ( from the European Organisation for Research and Treatment of Cancer [ EORTC ] Quality of Life Question naire C30 and the EORTC Brain Cancer Module ) were examined in 247 patients with anaplastic oligodendrogliomas to determine the relationship with overall survival by using Cox proportional hazards regression models . Refined techniques as the bootstrap resampling procedure and the computation of C indexes and R2 coefficients were used to explore the stability of the models as well as better assess the potential benefit of using HRQOL to predict survival in clinical practice and research . RESULTS Classical analysis controlled for major clinical prognostic factors selected emotional functioning ( P = .0016 ) , communication deficit ( P = .0261 ) , future uncertainty ( P = .0481 ) , and weakness of legs ( P = .0001 ) as statistically significant prognostic factors of survival . However , several issues question the validity of these findings and no single model was found to be preferable over all others . C indexes , which estimate the probability of a model to correctly predict which patient among a r and omly chosen pair of patients will survive longer , and R2 coefficients , which measure the proportion of variability explained by the model , did not exhibit major improvement when adding selected or all HRQOL scores to clinical factors . CONCLUSION While classical techniques lead to positive results , more refined analyses suggest that baseline HRQOL scores add relatively little to clinical factors to predict survival . These results may have implication s for future use of HRQOL as a prognostic factor for patients with cancer PURPOSE O6-methylguanine-methyltransferase ( MGMT ) promoter methylation has been shown to predict survival of patients with glioblastomas if temozolomide is added to radiotherapy ( RT ) . It is unknown if MGMT promoter methylation is also predictive to outcome to RT followed by adjuvant procarbazine , lomustine , and vincristine ( PCV ) chemotherapy in patients with anaplastic oligodendroglial tumors ( AOT ) . PATIENTS AND METHODS In the European Organisation for the Research and Treatment of Cancer study 26951 , 368 patients with AOT were r and omly assigned to either RT alone or to RT followed by adjuvant PCV . From 165 patients of this study , formalin-fixed , paraffin-embedded tumor tissue was available for MGMT promoter methylation analysis . This was investigated with methylation specific multiplex ligation-dependent probe amplification . RESULTS In 152 cases , an MGMT result was obtained , in 121 ( 80 % ) cases MGMT promoter methylation was observed . Methylation strongly correlated with combined loss of chromosome 1p and 19q loss ( P = .00043 ) . In multivariate analysis , MGMT promoter methylation , 1p/19q codeletion , tumor necrosis , and extent of resection were independent prognostic factors . The prognostic significance of MGMT promoter methylation was equally strong in the RT arm and the RT/PCV arm for both progression-free survival and overall survival . In tumors diagnosed at central pathology review as glioblastoma , no prognostic effect of MGMT promoter methylation was observed . CONCLUSION In this study , on patients with AOT MGMT promoter methylation was of prognostic significance and did not have predictive significance for outcome to adjuvant PCV chemotherapy . The biologic effect of MGMT promoter methylation or pathogenetic features associated with MGMT promoter methylation may be different for AOT compared with glioblastoma Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more The increased chemosensitivity of oligodendroglial tumors has been associated with loss of heterozygosity ( LOH ) on chromosomes 1p and 19q . Other clinical and molecular factors have also been identified as being prognostic and predictive for treatment outcome . Seventy-seven patients with anaplastic oligodendroglioma ( AO ) or anaplastic oligoastrocytoma ( AOA ) , treated in Beijing Tiantan Hospital from 2006 through 2008 , were review ed . LOH 1p , LOH 19q , IDH1 mutation , O(6)-methylguanine-DNA methyltransferase ( MGMT ) promoter methylation , and protein expression level of MGMT , P53 , EGFR , and Ki-67 were evaluated . Age at diagnosis , LOH 1p and 19q , IDH1 mutation , P53 expression level , reoperation when progression , and adjuvant chemotherapy were statistically significant factors for overall survival ( OS ) in univariate analysis . Further multivariate analysis showed that age at diagnosis ( P = .010 ) , LOH 1p and 19q ( P = .016 ) , IDH1 mutation ( P = .011 ) , and reoperation after progression ( P = .048 ) were independent predictors for longer survival in these patients . Nonr and om associations were found between LOH 1p and LOH 19q , MGMT promoter methylation and LOH 1p or 19q , IDH1 mutation and LOH 1p and 19q , IDH1 mutation and MGMT promoter methylation , whereas mutual exclusion was found between MGMT promoter methylation and MGMT expression level . The present study confirmed that age at diagnosis , LOH 1p and 19q , IDH1 mutation , and reoperation after progression were independent significant prognostic factors for patients with anaplastic oligodendroglial tumors . Inter-relationship between LOH 1p , LOH 19q , IDH1 mutation , MGMT promoter methylation , and MGMT expression level were also revealed . Future clinical trials for AO and AOA should consider the molecular alterations of patients PURPOSE The st and ard of care for anaplastic gliomas is surgery followed by radiotherapy . The NOA-04 phase III trial compared efficacy and safety of radiotherapy followed by chemotherapy at progression with the reverse sequence in patients with newly diagnosed anaplastic gliomas . PATIENTS AND METHODS Patients ( N = 318 ) were r and omly assigned 2:1:1 ( A : B1:B2 ) to receive conventional radiotherapy ( arm A ) ; procarbazine , lomustine ( CCNU ) , and vincristine ( PCV ; arm B1 ) ; or temozolomide ( arm B2 ) at diagnosis . At occurrence of unacceptable toxicity or disease progression , patients in arm A were treated with PCV or temozolomide ( 1:1 r and om assignment ) , whereas patients in arms B1 or B2 received radiotherapy . The primary end point was time to treatment failure ( TTF ) , defined as progression after radiotherapy and one chemotherapy in either sequence . RESULTS Patient characteristics in the intention-to-treat population ( n = 274 ) were balanced between arms . All histologic diagnoses were central ly confirmed . Median TTF ( hazard ratio [ HR ] = 1.2 ; 95 % CI , 0.8 to 1.8 ) , progression-free survival ( PFS ; HR = 1.0 ; 95 % CI , 0.7 to 1.3 , and overall survival ( HR = 1.2 ; 95 % CI , 0.8 to 1.9 ) were similar for arms A and B1/B2 . Extent of resection was an important prognosticator . Anaplastic oligodendrogliomas and oligoastrocytomas share the same , better prognosis than anaplastic astrocytomas . Hypermethylation of the O(6)-methylguanine DNA-methyltransferase ( MGMT ) promoter ( HR = 0.59 ; 95 % CI , 0.36 to 1.0 ) , mutations of the isocitrate dehydrogenase ( IDH1 ) gene ( HR = 0.48 ; 95 % CI , 0.29 to 0.77 ) , and oligodendroglial histology ( HR = 0.33 ; 95 % CI , 0.2 to 0.55 ) reduced the risk of progression . Hypermethylation of the MGMT promoter was associated with prolonged PFS in the chemotherapy and radiotherapy arm . CONCLUSION Initial radiotherapy or chemotherapy achieved comparable results in patients with anaplastic gliomas . IDH1 mutations are a novel positive prognostic factor in anaplastic gliomas , with a favorable impact stronger than that of 1p/19q codeletion or MGMT promoter methylation Purpose : Recent studies have shown the prognostic significance of IDH1 mutations in glioma . It is yet unclear if IDH1 mutations are predictive for outcome to chemotherapy . We determined the effect of IDH1 mutations on progression-free survival and overall survival ( OS ) , and its correlation with other clinical and molecular features in the prospect i ve r and omized European Organization for Research and Treatment of Cancer study 26951 on adjuvant procarbazine , 1-(2-chloroethyl)-3-cyclohexyl-l-nitrosourea , and vincristine ( PCV ) in anaplastic oligodendroglioma . Experimental Design : IDH1 and IDH2 alterations of the mutational hotspot codons R132 and R172 were assessed by the bidirectional cycle sequencing of PCR-amplified fragments . MGMT promoter methylation was assessed using methylation-specific multiplex ligation – dependant probe amplification based on methylation-sensitive restriction analysis . Loss of chromosomes 1p , 19q , 10 , and 10q and the gain of 7 and the EGFR gene were assessed with fluorescence in situ hybridization . Results : From 159 patients , sufficient material was available for IDH1 analysis . In 151 and 118 of these patients , respectively , the 1p/19q status and the MGMT promoter methylation status were known . In 73 cases ( 46 % ) , an IDH1 mutation was found and only one IDH2 mutation was identified . The presence of IDH1 mutations correlated with 1p/19q codeletion and MGMT promoter methylation , and inversely correlated with loss of chromosome 10 , EGFR amplification , polysomy of chromosome 7 , and the presence of necrosis . IDH1 mutations were found to be prognostic in the radiotherapy- and the radiotherapy/PCV-treated patients , for both progression-free survival and OS . With Cox proportional hazard modeling for OS with stepwise selection , IDH1 mutations and 1p/19q codeletion but not MGMT promoter methylation were independent prognostic factors . Conclusion : In this homogeneously treated group of anaplastic oligodendroglioma patients , the presence of IDH1 mutations was found to carry a very strong prognostic significance for OS but without evidence of a predictive significance for outcome to PCV chemotherapy . IDH1 mutations were strongly associated with 1p/19q codeletion
Output:
| AUTHORS ' CONCLUSIONS Early PCV , either before or after RT , appears to improve OS of participants with AO or AOA .
Use of biomarkers including codeletion of chromosomes 1p and 19q with or without IDH-1 or -2 mutation identify a subset of people with increased sensitivity to combined PCV and RT .
However , PCV was associated with significant grade 3 and 4 toxicities , and whether temozolomide can be substituted for this remains unclear |
MS212479 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE By means of a r and omized double-blind study , the effect of providing taped initial consultations on cancer patients ' satisfaction , recall , and quality of life was investigated . PATIENTS AND METHODS Consecutive cancer patients referred to either the gynecology or medical oncology outpatient clinic were eligible . Initial consultations were audiotaped . Patients were either provided with the tape ( experimental group ) or not ( control group ) . Baseline variables included sociodemographics , preferences for information , coping styles , and clinical characteristics . Follow-up ( after 1 week and 3 months ) variables included attitudes toward the intervention , satisfaction , recall , and quality of life . Assessment s took place through mailed question naires and telephone interviews . RESULTS Two hundred one patients were included ( response , 71 % ) , 105 in the experimental group and 96 in the control group . Most patients ( 75 % ) listened to the tape , the majority of which ( 73 % ) listened with others . Almost all patients , both in the experimental group ( 96 % ) and control group ( 98 % ) were positive about the intervention . Expectations were confirmed ; patients provided with the tape were more satisfied ( P < .05 ) and recalled more information ( P < .01 ) than patients without the tape . The intervention did not have an effect on quality of life . An interaction effect was found between the intervention and patients ' age on satisfaction with the taped consultation ( P < .01 ) and recall of diagnostic information ( P < .01 ) ; access to tapes seems more helpful in enhancing satisfaction in younger patients and recall of diagnostic information in older patients . CONCLUSION Cancer patients and their families value the taped initial consultation . This intervention enhances their satisfaction and improves their recall of information . Tapes seem more helpful in enhancing satisfaction in younger patients and recall of diagnostic information in older patients OBJECTIVES To evaluate the impact of an information booklet on HIV clinical trials , Clinical Trials in HIV and AIDS : Information For People Who Are Thinking About Joining a Trial , in addition to the st and ard trial information ( SI ) on patients ' knowledge ; underst and ing and attitudes about clinical trials ; and to investigate patients ' motivations and reasons for enrolling or not enrolling in a clinical trial . METHODS Fifty HIV-1 positive patients who attended the HIV clinic at a west London hospital were r and omized to receive either SI alone ( n = 27 ) or SI and a 16 page information booklet explaining the principles and procedures of HIV clinical trials ( n = 23 ) . A self-administered question naire was used at baseline to assess past experience and attitudes to clinical trials ( 10 questions ) , knowledge and underst and ing of HIV treatments ( 8 questions ) and clinical trials ( 11 questions ) . At 2 - 6 months after r and omization , a second interviewer-administered question naire addressed the patient 's assessment of the usefulness and comprehensiveness of the information provided by the SI and information booklet , whether or not the patient had enrolled in a clinical trial and reasons for enrolling/not enrolling , knowledge of specific aspects of the trial protocol the patient was eligible to join ( 13 questions ) and general knowledge of clinical trial procedures ( repeat of 11 baseline questions ) . Changes in the attitudes and scores on knowledge and underst and ing of clinical trials were compared for the two groups . RESULTS In both groups , patient knowledge of clinical trial procedures improved significantly over the study period . The median score increased from 30 at baseline to 35/44 at follow-up ( SI only ) vs. 24 - 31/44 ( SI plus booklet ) , but this did not differ significantly between the two groups . However , knowledge of the specific trial protocol was poor [ median score 13/25 , interquartile range ( IQR ) 8 - 14 ] , and there was no difference in the scores for the two groups . The prime motivations for joining a clinical trial were to benefit personal health and to gain access to new treatments . Potential side-effects were the main concern of prospect i ve trial participants . CONCLUSIONS This small trial shows that , while the patients ' general knowledge and underst and ing of clinical trials improved over time , this was not improved by the information booklet and re collection of the details of the relevant trial protocol remained poor Active participation in the medical consultation has been demonstrated to benefit aspects of patients ’ subsequent psychological well-being . We investigated two interventions promoting patient question -asking behaviour . The first was a question prompt sheet provided before the consultation , which was endorsed and worked through by the clinician . The second was a face to face coaching session exploring the benefits of , and barriers to , question -asking , followed by coaching in question -asking behaviour employing rehearsal techniques . Sixty patients with heterogeneous cancers , seeing two medical oncologists for the first time , were r and omly assigned to one of three groups : two intervention groups and one control group . Sociodemographic variables and anxiety were assessed prior to the intervention which preceded the consultation . The consultations were audiotaped and subsequently analysed for question -asking behaviour . Anxiety was assessed again immediately following the consultation . Question naires to assess patient satisfaction , anxiety and psychological adjustment were sent by mail 2 weeks following the consultation . Presentation and discussion of the prompt sheet significantly increased the total number of questions asked and the number of questions asked regarding tests and treatment . Coaching did not add significantly to the effects of the prompt sheet . Psychological outcomes were not different among the groups . We conclude that a question prompt sheet addressed by the doctor is a simple , inexpensive and effective means of promoting patient question asking in the cancer consultation Patient participation in medical consultations has been demonstrated to benefit their subsequent psychological well being . Question asking is one way in which patients can be active . We investigated 2 means of promoting cancer patient question asking . One was the provision of a question prompt sheet to patients prior to their initial consultation with their oncologist . The second was the active endorsement and systematic review of the question prompt sheet by their oncologist . 318 patients with heterogeneous cancers , seeing one of 5 medical and 4 radiation oncologists for the first time , were r and omised to either receive or not receive a question prompt sheet . Doctors were r and omised to either proactively address or passively respond to the question prompt sheet in the subsequent consultation . Anxiety was assessed prior to the consultation . Consultations were audiotaped and content analysed . Anxiety was assessed again immediately following the consultation . Within the next 10 days patients completed question naires assessing information needs , anxiety and satisfaction and were given a structured telephone interview assessing information recall . Patients provided with a question prompt sheet asked more questions about prognosis compared with controls and oncologists gave significantly more prognostic information to these patients . Provision of the question prompt sheet prolonged consultations and increased patient anxiety ; however , when oncologists specifically addressed the prompt sheet , anxiety levels were significantly reduced , consultation duration was decreased and recall was significantly improved . A patient question prompt sheet , used proactively by the doctor , is a powerful addition to the oncology consultation . © 2001 Cancer Research Campaign PURPOSE Women with breast cancer were provided with an audiotape of their primary adjuvant treatment consultation , and the following patient outcomes were measured at 12 weeks postconsultation : perceived degree of information provision , audiotape satisfaction and use , communication satisfaction with oncologist , mood state , and cancer-specific quality of life . PATIENTS AND METHODS Participants included 628 women newly diagnosed with breast cancer and 40 oncologists from six cancer centers in Canada . The patients were block r and omized to one of four consultation groups : st and ard care control , not audiotaped ; audiotaped , no audiotape given ; audiotaped , patient given audiotape ; and audiotaped , patient offered choice of receiving audiotape or not . RESULTS Patients receiving the consultation audiotape had significantly better recall of having discussed side effects of treatment than patients who did not receive the audiotape . Audiotape benefit was not significantly related to patient satisfaction with communication , mood state , or quality of life at 12 weeks postconsultation , and was not significantly affected by choice of receiving the audiotape . Patients rated the audiotape intervention positively , with an average score of 83.9 of 100 . CONCLUSION Audiotape provision benefits patients by facilitating their perception of being informed about treatment side effects , but does not significantly influence patient satisfaction with communication , mood state , or quality of life PURPOSE Studies of tape recordings of cancer consultations have produced conflicting results . At the same time , audiotapes containing general information about cancer are poorly evaluated and are distributed to patients in an ad hoc manner . We compared the effects of both interventions on patient satisfaction , psychologic adjustment , and recall of information following their first consultation with a medical oncologist . PATIENTS AND METHODS Patients ( n = 142 ) were r and omized to receive ( 1 ) an audiotape of their consultation , ( 2 ) an audiotape describing cancer in general terms , or ( 3 ) no tape . Recall of information was assessed in a structured interview 4 to 20 days after the consultation . RESULTS Satisfaction with the consultation increased linearly from no tape to general tape to consultation tape . Satisfaction with the tape itself was higher in patients who received the consultation tape ( satisfaction score , 61 % ) compared with those who received the general tape ( 43 % ) . Average recall for all groups was 6.4 of the 25 items of information presented , and 2.4 of the six points identified as particularly important by the oncologist . The consultation tape did not improve recall over the no tape control , but the general tape caused a decrease of almost two items in total recall . Spontaneous ( ie , unprompted ) recall was significantly poorer with the general information tape . Psychologic adjustment to cancer was unaffected . CONCLUSION We conclude that individual audiotapes have a limited potential to increase recall of information from the oncology consultation . General information tapes about cancer appear to inhibit recall actively Abstract OBJECTIVE : To assess the effect of video and pamphlet interventions on patient prostate cancer ( CaP ) screening knowledge , decision-making participation , preferences , and behaviors . DESIGN : R and omized , controlled trial . SETTING : Four midwestern Veterans Affairs medical facilities . PATIENTS / PARTICIPANTS : One thous and , one hundred fifty-two male veterans age 50 and older with primary care appointments at participating facilities were r and omized and 893 completed follow-up . INTERVENTIONS : Patients were r and omized to mailed pamphlet , mailed video , or usual care/control . MEASUREMENTS AND MAIN RESULTS : Outcomes assessed by phone survey 2 weeks postintervention included a 10-item knowledge index ; correct responses to questions on CaP natural history , treatment efficacy , the prostate-specific antigen ( PSA ) ’s predictive value , and expert disagreement about the PSA ; whether screening was discussed with provider ; screening preferences ; and PSA testing rates . Mean knowledge index scores were higher for video ( 7.44 ; P=.001 ) and pamphlet ( 7.26 ; P=.03 ) subjects versus controls ( 6.90 ) . Video and pamphlet subjects reported significantly higher percentages of correct responses relative to controls to questions on CaP natural history ( 63 % , 63 % , and 54 % , respectively ) ; treatment efficacy ( 19 % , 20 % , and 5 % ) , and expert disagreement ( 28 % , 19 % , and 8 % ) , but not PSA accuracy ( 28 % , 22 % , and 22 % ) . Pamphlet subjects were more likely than controls to discuss screening with their provider ( 41 % vs 32 % ; P=.03 ) but video subjects were not ( 35 % ; P=.33 ) . Video and pamphlet subjects were less likely to intend to have a PSA , relative to controls ( 63 % , 65 % , and 74 % , respectively ) . PSA testing rates did not differ significantly across groups . CONCLUSIONS : Mailed interventions enhance patient knowledge and self-reported participation in decision making , and alter screening preferences . The pamphlet and video interventions evaluated are comparable in effectiveness . The lower-cost pamphlet approach is an attractive option for clinics with limited re sources Open or uncontrolled studies have suggested that providing cancer patients with audiotapes of their clinical interviews can improve information recall and reduce psychological distress . We tested these hypotheses in a ' clinician-blind ' , prospect i ve , r and omised controlled trial . A total of 117 patients newly referred to a medical oncology clinic who were to be given ' bad news ' had their consultations audiotaped . Blind to the clinician , patients were r and omly allocated to receive a copy of the tape to play at home or not ( control group ) . At 6 months follow-up , tape group patients reported positive attitudes to the audiotape and were shown to recall significantly more information about their illness than did controls . Overall improvement in psychological distress at 1 and 6 months follow-up , as measured with the 30-item General Health Question naire and the Hospital Anxiety and Depression Scale was no different in the two groups . However , a second-order interaction suggested that poor-prognosis patients were disadvantaged specifically by access to the audiotape , with less improvement in psychological distress at 6 months follow-up than non-tape controls . Patient access to audiotapes of clinical interviews promotes factual retention but does not reliably reduce psychological distress and may be actively unhelpful in some subgroups of patients Summary A range of measures have been proposed to enhance the provision of information to cancer patients and r and omized controlled trials have demonstrated their impact on patient satisfaction and recall . The current study explored the practice and views of oncologists , surgeons and general practitioners ( GPs ) with regards to providing patients with consultation audiotapes and summary letters . In stage 1 , 28 semi-structured interviews with doctors were conducted to provide qualitative data on which to base a question naire . In stage 2 , 113 medical oncologists , 43 radiation oncologists , 55 surgeons and 108 GPs completed question na
Output:
| The results indicate that an audiotape of the patients ' own consultation has added value upon oral information only .
However , providing patients with a general audiotape does not improve recall of information and might even inhibit patients ' recall .
Furthermore , there is scientific evidence , although limited , that the use of a question prompt sheet ( QPS ) has a positive effect on recall of information , provided that the physician actively endorses this sheet .
No evidence was found for an effect of providing patients with a summary letter of the consultation on recall , although research on this subject is scarce .
In conclusion , the review suggests that interventions that are tailored to the individual cancer patient , such as an audiotape of the consultation or a QPS , are most effective . |
MS212480 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE We sought to determine whether information on hospital charges ( prices ) would affect test-ordering and quality of patient care in a pediatric emergency department ( ED ) . DESIGN Prospect i ve , nonblind , controlled trial of price information . SETTING Urban , university-affiliated pediatric ED . METHODS We prospect ively assessed patients 2 months to 10 years of age with a presenting temperature > /=38.5 degrees C or complaint of vomiting , diarrhea , or decreased oral intake . The assessment s were done during three periods : September 1997 through December 1997 ( control ) , January 1998 through March 1998 ( intervention ) , and April 1998 ( washout ) . In the control and washout periods , physicians noted tests ordered on a list attached to each chart . In the intervention period , physicians noted tests ordered on a similar list that included st and ard hospital charges for each test . Records of each visit were review ed to determine clinical and demographic information as well as patient disposition . In the control and intervention periods , families of nonadmitted patients were interviewed by telephone 7 days after the visit . RESULTS When controlled for triage level , vital signs , and admission rates , in a multivariate model , charges for tests in the intervention period were 27 % less than charges in the control period . The greatest decrease was seen among low-acuity , nonadmitted patients ( 43 % ) . In telephone follow-up , patients in the intervention period were slightly more likely to have made an unscheduled follow-up visit to a health care provider ( 24.4 % vs 17.8 % ) , but did not differ on improved condition ( 86.7 % vs 83.4 % ) or family satisfaction ( 93.8 % vs 93.0 % ) . Adjusted charges in the washout period were 15 % lower than in the control period and 15 % higher than in the intervention period . CONCLUSION Providing price information was associated with a significant reduction in charges for tests ordered on pediatric ED patients with acute illness not requiring admission . This decrease was associated with a slightly higher rate of unscheduled follow-up , but no difference in subjective outcomes or family satisfaction Background Prior studies have demonstrated how price transparency lowers the test-ordering rates of trainees in hospitals , and physician-targeted price transparency efforts have been viewed as a promising cost-controlling strategy . Objective To examine the effect of displaying paid-price information on test-ordering rates for common imaging studies and procedures within an accountable care organization ( ACO ) . Design Block r and omized controlled trial for 1 year . SubjectsA total of 1205 fully licensed clinicians ( 728 primary care , 477 specialists ) . InterventionS tarting January 2014 , clinicians in the Control arm received no price display ; those in the intervention arms received Single or Paired Internal/External Median Prices in the test-ordering screen of their electronic health record . Internal prices were the amounts paid by insurers for the ACO ’s services ; external paid prices were the amounts paid by insurers for the same services when delivered by unaffiliated providers . Main Measures Ordering rates ( orders per 100 face-to-face encounters with adult patients ): overall , design ated to be completed internally within the ACO , considered “ inappropriate ” ( e.g. , MRI for simple headache ) , and thought to be “ appropriate ” ( e.g. , screening colonoscopy).Key Results We found no significant difference in overall ordering rates across the Control , Single Median Price , or Paired Internal/External Median Prices study arms . For every 100 encounters , clinicians in the Control arm ordered 15.0 ( SD 31.1 ) tests , those in the Single Median Price arm ordered 15.0 ( SD 16.2 ) tests , and those in the Paired Prices arms ordered 15.7 ( SD 20.5 ) tests ( one-way ANOVA p-value 0.88 ) . There was no difference in ordering rates for tests design ated to be completed internally or considered to be inappropriate or appropriate . Conclusions Displaying paid-price information did not alter how frequently primary care and specialist clinicians ordered imaging studies and procedures within an ACO . Those with a particular interest in removing waste from the health care system may want to consider a variety of context ual factors that can affect physician-targeted price transparency PURPOSE The aim of this study was to determine whether presenting providers with cost information at the point of order entry significantly influences imaging utilization . METHODS Using data from fiscal year 2007 , the 10 most frequently ordered imaging tests were identified . Five of these were r and omly assigned to the active cost display group and 5 to the control group . During a 6-month baseline period from November 10 , 2008 , to May 9 , 2009 , no costs were displayed . During a seasonally matched intervention period from November 10 , 2009 , to May 9 , 2010 , costs were displayed only for tests in the active group . At the conclusion of the study , the radiology information system was queried to determine the number of orders executed for all tests during both periods . The main outcome measure was the mean relative utilization change between the control and intervention periods for the active group vs the control group . An additional measure was the correlation between test cost and utilization change in the active group vs the control group . RESULTS The mean utilization change was + 2.8 ± 4.4 % for the active group and -3.0 ± 5.5 % for the control group , with no significant difference between the two groups ( P = .10 , Student 's t-test ) . There was also no significant difference in the correlation between test cost and utilization change for the active group vs the control group ( P = .25 , Fisher 's z-test ) . On the basis of the observed st and ard deviations , this study had 90 % power to detect an 11.8 % difference in mean relative utilization change between groups . CONCLUSIONS Provider cost transparency alone does not significantly influence inpatient imaging utilization Objectives To determine the impact of systemwide charge display on laboratory utilization . Methods This was a r and omized controlled trial with a baseline period and an intervention period . Tests were r and omized to a control arm or an active arm . The maximum allowable Medicare reimbursement rate was displayed for tests in the active arm during the intervention period . Total volume of tests in the active arm was compared with those in the control arm . Residents were surveyed before and after the intervention to assess charge awareness . Results Charge display had no effect on order behavior . This result held for patient type ( inpatient vs outpatient ) and for insurance category ( commercial , government , self-pay ) . Residents overestimated the charges of tests both before and after the intervention . Many residents failed to notice the charge display in the computerized order entry system . Conclusions The impact of charge display depends on context . Charge display is not always effective OBJECTIVE To assess the effects on health care re source utilization of a network of microcomputer workstations for writing all inpatient orders . DESIGN R and omized controlled clinical trial . SETTING Inpatient internal medicine service of an urban public hospital . SUBJECTS A total of 5219 internal medicine patients and the 68 teams of house officers , medical students , and faculty internists who cared for them . INTERVENTION Microcomputer workstations , linked to a comprehensive electronic medical record system , for writing all inpatient orders . MAIN OUTCOME MEASURES Total inpatient charges for each admission and charges for specific categories of orders . A time-motion study of selected interns assessed the ordering system 's time consumption . RESULTS Intervention teams generated charges that were $ 887 ( 12.7 % ) lower per admission than did control teams ( P = .02 ) . Significant reductions ( P < .05 ) were demonstrated separately for bed charges , diagnostic test charges , and drug charges . Reductions of similar proportion and statistical significance were found for hospital costs . The mean length of stay was 0.89 day shorter for intervention resident teams ( P = .11 ) . Interns in the intervention group spent an average of 33 minutes longer ( 5.5 minutes per patient ) during a 10-hour observation period writing orders than did interns in the control group ( P < .0001 ) . CONCLUSIONS A network of microcomputer workstations for writing all inpatient orders significantly lowered patient charges and hospital costs . This would amount to savings of more than $ 3 million in charges annually for this hospital 's medicine service and potentially tens of billions of dollars nationwide . However , the system required more physician time than did the paper charts . Research at other sites and system advances to reduce time requirements are warranted BACKGROUND AND OBJECTIVES : Ordering rates for imaging studies and procedures may change if clinicians are shown the prices of those tests while they are ordering . We studied the effect of 2 forms of paid price information , single median price and paired internal/external median prices , on how often pediatric-focused and adult-oriented clinicians ( most frequently general pediatricians and adult specialists caring for pediatric-aged patients , respectively ) order imaging studies and procedures for 0- to 21-year-olds . METHODS : In January 2014 , we r and omized 227 pediatric-focused and 279 adult-oriented clinicians to 1 of 3 study arms : Control ( no price display ) , Single Median Price , or Paired Internal/External Median Prices ( both with price display in the ordering screen of electronic health record ) . We used 1-way analysis of variance and paired t tests to examine how frequently clinicians ( 1 ) placed orders and ( 2 ) design ated tests to be completed internally within an accountable care organization . RESULTS : For pediatric-focused clinicians , there was no significant difference in the rates at which orders were placed or design ated to be completed internally across the study arms . For adult-oriented clinicians caring for children and adolescents , however , those in the Single Price and Paired Price arms placed orders at significantly higher rates than those in the Control group ( Control 3.2 [ SD 4.8 ] , Single Price 6.2 [ SD 6.8 ] , P < .001 and Paired Prices 5.2 [ SD 7.9 ] , P = .04 ) . The rate at which adult-oriented clinicians design ated tests to be completed internally was not significantly different across arms . CONCLUSIONS : The effect of price information on ordering rates appears to depend on whether the clinician is pediatric-focused or adult-oriented We studied the effect of informing physicians of the charges for outpatient diagnostic tests on their ordering of such tests in an academic primary care medical practice . All tests were ordered at microcomputer workstations by 121 physicians . For half ( the intervention group ) , the charge for the test being ordered and the total charge for tests for that patient on that day were displayed on the computer screen . The remaining physicians ( control group ) also used the computers but received no message about charges . The primary outcomes measured were the number of tests ordered and the charges for tests per patient visit . In the 14 weeks before the study , the number of tests ordered and the average charge for tests per patient visit were similar for the intervention and control groups . During the 26-week intervention period , the physicians in the intervention group ordered 14 percent fewer tests per patient visit than did those in the control group ( P less than 0.005 ) , and the charges for tests were 13 percent ( $ 6.68 per visit ) lower ( P less than 0.05 ) . The differences were greater for scheduled visits ( 17 percent fewer tests and 15 percent lower charges for the intervention group ; P less than 0.01 ) than for unscheduled ( urgent ) visits ( 11 percent fewer tests and 10 percent lower charges ; P greater than 0.3 ) . During the 19 weeks after the intervention ended , the number of tests ordered by the physicians in the intervention group was only 7.7 percent lower than the number ordered by the physicians in the control group , and the charges for tests were only 3.5 percent lower ( P greater than 0.3 ) . Three measures of possible adverse outcomes --number of hospitalizations , emergency room visits , and outpatient visits during the study period and the following six months -- were similar for the patients seen by the physicians in both groups . We conclude that displaying the charges for diagnostic tests significantly reduced the number and cost of tests ordered , especially for patients with scheduled visits . The effects of this intervention did not persist after it was discontinued Objectives The aim of this study was to establish whether price list information could reduce laboratory and radiological examination costs in emergency departments ( EDs ) . Material s and methods A prospect i ve survey of adult ( > 16 years old ) admissions was conducted at the ED of a university hospital in Belgium . Nine resident emergency physicians were followed for a span of 6 months , which was divided into 2-month periods : control ( October and November 2011 ) , intervention ( December 2011 to January 2012 ) , and washout ( February and March 2012 ) . Laboratory and radiological costs for each of the daily admissions were calculated during the respective periods and compared . Results A total of 3758 patients were registered : 1093 in period 1 ( control ) , 1329 in period 2 ( intervention ) , and 1336 in period 3 ( washout ) . We observed significant reductions in examination costs : 10.73 % ( P=0.015 ) for laboratory and 33.66 % ( P<0.001 ) for radiological costs in period 2 versus period 1 ; 5.02 % ( P=0.014 ) for laboratory and 40.00 % ( P<0.001 ) for radiological costs in period 3 versus period 1 . In addition , we found that laboratory examination costs increased slightly between periods 2 and 3 ( + 6.4 % ) , whereas costs related to radiologic examinations continued to decrease ( −10.16 % ) ; however , these differences were not statistically significant . Conclusion We conclude that the distribution of price lists at EDs promotes cost awareness , which can result in significant decreases in examination costs Objective Reference tests , also known as send-out tests , are commonly ordered labor
Output:
| Provider price display in electronic health record environment did not consistently influence domains of healthcare quality such as efficiency , effectiveness and patient safety .
Conclusions Published evidence suggests that price display tools aim ed at ordering providers in EHR/CPOE do not influence the efficiency domain of healthcare quality .
Scant published evidence suggests that they do not influence the effectiveness and patient safety domains of healthcare quality . |
MS212481 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Patients with type 2 diabetes mellitus ( T2DM ) with a glycated haemoglobin ( HbA1c ) level ≥7 and ≤10 % were r and omized to receive empagliflozin 12.5 mg twice daily ( n = 219 ) , 25 mg once daily ( n = 218 ) , 5 mg twice daily ( n = 219 ) or 10 mg once daily ( n = 220 ) , or placebo ( n = 107 ) as add‐on to stable‐dose metformin immediate release ( IR ) twice daily for 16 weeks . The primary endpoint was change from baseline in HbA1c at week 16 . At week 16 , change from baseline in HbA1c with empagliflozin twice daily was non‐inferior to empagliflozin once daily and vice versa . The adjusted mean ( 95 % confidence interval ) difference in change from baseline in HbA1c with empagliflozin 12.5 mg twice daily versus 25 mg once daily was −0.11 % ( −0.26 , 0.03 ) , and with empagliflozin 5 mg twice daily versus 10 mg once daily it was −0.02 % ( −0.16 , 0.13 ) . All empagliflozin regimens were well tolerated ; thus , when used as add‐on to metformin IR in patients with T2DM , the therapeutic effect of empagliflozin twice‐daily and once‐daily regimens can be considered equivalent Background and Purpose — In the EMPA-REG OUTCOME trial ( Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients ) , empagliflozin added to st and ard of care in patients with type 2 diabetes mellitus and high cardiovascular risk reduced the risk of 3-point major adverse cardiovascular events , driven by a reduction in cardiovascular mortality , with no significant difference between empagliflozin and placebo in risk of myocardial infa rct ion or stroke . In a modified intent-to-treat analysis , the hazard ratio for stroke was 1.18 ( 95 % confidence interval , 0.89–1.56 ; P=0.26 ) . We further investigated cerebrovascular events . Methods — Patients were r and omized to empagliflozin 10 mg , empagliflozin 25 mg , or placebo ; 7020 patients were treated . Median observation time was 3.1 years . Results — The numeric difference in stroke between empagliflozin and placebo in the modified intent-to-treat analysis was primarily because of 18 patients in the empagliflozin group with a first event > 90 days after last intake of study drug ( versus 3 on placebo ) . In a sensitivity analysis based on events during treatment or ⩽90 days after last dose of drug , the hazard ratio for stroke with empagliflozin versus placebo was 1.08 ( 95 % confidence interval , 0.81–1.45 ; P=0.60 ) . There were no differences in risk of recurrent , fatal , or disabling strokes , or transient ischemic attack , with empagliflozin versus placebo . Patients with the largest increases in hematocrit or largest decreases in systolic blood pressure did not have an increased risk of stroke . Conclusions — In patients with type 2 diabetes mellitus and high cardiovascular risk , there was no significant difference in the risk of cerebrovascular events with empagliflozin versus placebo . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01131676 OBJECTIVE To investigate the efficacy , safety , and tolerability of empagliflozin in patients with type 2 diabetes and hypertension . RESEARCH DESIGN AND METHODS Patients ( N = 825 ) with type 2 diabetes and hypertension ( mean seated systolic blood pressure [ SBP ] 130–159 mmHg and diastolic blood pressure [ DBP ] 80–99 mmHg ) were r and omized ( double blind ) to 10 mg or 25 mg empagliflozin or placebo once daily for 12 weeks . RESULTS At week 12 , adjusted mean difference versus placebo in change from baseline in mean 24-h SBP ( ambulatory blood pressure monitoring [ ABPM ] ) was −3.44 mmHg ( 95 % CI −4.78 , −2.09 ) with 10 mg empagliflozin and −4.16 mmHg ( −5.50 , −2.83 ) with 25 mg empagliflozin ( both P < 0.001 ) . At week 12 , adjusted mean difference versus placebo in change from baseline in mean 24-h DBP ( ABPM ) was −1.36 mmHg ( 95 % CI −2.15 , −0.56 ) with 10 mg empagliflozin and −1.72 mmHg ( 95 % CI −2.51 , −0.93 ) with 25 mg empagliflozin ( both P < 0.001 ) . Changes in office BP were consistent with ABPM . Adjusted mean difference versus placebo in change from baseline in HbA1c at week 12 was −0.62 % ( 95 % CI −0.72 , −0.52 ) ( −6.8 mmol/mol [ 95 % CI −7.9 , −5.7 ] ) with 10 mg empagliflozin and −0.65 % ( 95 % CI −0.75 , −0.55 ) ( −7.1 mmol/mol [ 95 % CI −8.2 , −6.0 ] ) with 25 mg empagliflozin ( both P < 0.001 ) . Empagliflozin was well tolerated . One patient on placebo and one patient on 10 mg empagliflozin reported events consistent with volume depletion . CONCLUSIONS Empagliflozin was associated with significant and clinical ly meaningful reductions in BP and HbA1c versus placebo and was well tolerated in patients with type 2 diabetes and hypertension Background This study evaluated the effect of empagliflozin on postpr and ial glucose ( PPG ) and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus ( T2DM ) . Methods Patients ( N = 60 ; baseline mean [ SD ] HbA1c 7.91 [0.80]% ; body mass index 24.3 [ 3.2 ] kg/m2 ) were r and omized to receive empagliflozin 10 mg ( n = 20 ) , empagliflozin 25 mg ( n = 19 ) or placebo ( n = 21 ) once daily as monotherapy for 28 days . A meal tolerance test and continuous glucose monitoring ( CGM ) for 24 hours were performed at baseline and on days 1 and 28 . The primary endpoint was change from baseline in area under the glucose concentration-time curve 3 hours after breakfast ( AUC1–4h for PPG ) at day 28 . Results Adjusted mean ( 95 % ) differences versus placebo in changes from baseline in AUC1 - 4h for PPG at day 1 were −97.1 ( −126.5 , −67.8 ) mg · h/dl with empagliflozin 10 mg and −91.6 ( −120.4 , −62.8 ) mg · h/dl with empagliflozin 25 mg ( both p < 0.001 versus placebo ) and at day 28 were −85.5 ( −126.0 , −45.0 ) mg · h/dl with empagliflozin 10 mg and −104.9 ( −144.8 , −65.0 ) mg · h/dl with empagliflozin 25 mg ( both p < 0.001 versus placebo ) . Adjusted mean ( 95 % CI ) differences versus placebo in change from baseline in 24-hour mean glucose ( CGM ) at day 1 were −20.8 ( −27.0 , −14.7 ) mg/dl with empagliflozin 10 mg and −23.9 ( −30.0 , −17.9 ) mg/dl with empagliflozin 25 mg ( both p < 0.001 versus placebo ) and at day 28 were −24.5 ( −35.4 , −13.6 ) mg/dl with empagliflozin 10 mg and −31.7 ( −42.5,-20.9 ) mg/dl with empagliflozin 25 mg ( both p < 0.001 versus placebo ) . Changes from baseline in mean amplitude of glucose excursions ( MAGE ; CGM ) were not significantly different with either empagliflozin dose versus placebo at either timepoint . Curves of mean glucose ( CGM ) did not change between baseline and day 1 or 28 with placebo , but shifted downward with empagliflozin . Percentage of time with glucose ≥70 to < 180 mg/dl increased from 52.0 % at baseline to 77.0 % at day 28 with empagliflozin 10 mg and from 55.0 % to 81.1 % with empagliflozin 25 mg , without increasing time spent with hypoglycemia . Conclusion Empagliflozin for 28 days reduced PPG from the first day and improved daily blood glucose control in Japanese patients with T2DM.Trial registration Clinical trials.gov OBJECTIVE We investigated the efficacy and safety of the sodium glucose cotransporter 2 inhibitor , empagliflozin , added to multiple daily injections of insulin ( MDI insulin ) in obese patients with type 2 diabetes mellitus ( T2DM ) . RESEARCH DESIGN AND METHODS Patients inadequately controlled on MDI insulin ± metformin ( mean HbA1c 8.3 % [ 67 mmol/mol ] ; BMI 34.8 kg/m2 ; insulin dose 92 international units/day ) were r and omized and treated with once-daily empagliflozin 10 mg ( n = 186 ) , empagliflozin 25 mg ( n = 189 ) , or placebo ( n = 188 ) for 52 weeks . Insulin dose was to remain stable in weeks 1–18 , adjusted to meet glucose targets in weeks 19–40 , then stable in weeks 41–52 . The primary end point was change from baseline in HbA1c at week 18 . Secondary end points were changes from baseline in insulin dose , weight , and HbA1c at week 52 . RESULTS Adjusted mean ± SE changes from baseline in HbA1c were −0.50 ± 0.05 % ( −5.5 ± 0.5 mmol/mol ) for placebo versus −0.94 ± 0.05 % ( −10.3 ± 0.5 mmol/mol ) and −1.02 ± 0.05 % ( −11.1 ± 0.5 mmol/mol ) for empagliflozin 10 mg and empagliflozin 25 mg , respectively , at week 18 ( both P < 0.001 ) . At week 52 , further reductions with insulin titration result ed in changes from baseline in HbA1c of −0.81 ± 0.08 % ( −8.9 ± 0.9 mmol/mol ) , −1.18 ± 0.08 % ( −12.9 ± 0.9 mmol/mol ) , and −1.27 ± 0.08 % ( −13.9 ± 0.9 mmol/mol ) with placebo , empagliflozin 10 mg , and empagliflozin 25 mg , respectively , and final HbA1c of 7.5 % ( 58 mmol/mol ) , 7.2 % ( 55 mmol/mol ) , and 7.1 % ( 54 mmol/mol ) , respectively . More patients attained HbA1c < 7 % ( < 53 mmol/mol ) with empagliflozin ( 31–42 % ) versus placebo ( 21 % ; both P < 0.01 ) . Empagliflozin 10 mg and empagliflozin 25 mg reduced insulin doses ( −9 to −11 international units/day ) and weight ( −2.4 to −2.5 kg ) versus placebo ( all P < 0.01 ) at week 52 . CONCLUSIONS In obese , difficult-to-treat patients with T2DM inadequately controlled on high MDI insulin doses , empagliflozin improved glycemic control and reduced weight without increasing the risk of hypoglycemia and with lower insulin requirements OBJECTIVE To investigate the efficacy and tolerability of empagliflozin as add-on to metformin and sulfonylurea in patients with type 2 diabetes . RESEAR
Output:
| In conclusion , empagliflozin reduces systolic and diastolic blood pressure , uric acid , hemoglobin A1c , fasting plasma glucose , and body weight .
These data suggest the beneficial effects of empagliflozin on these cardiovascular risk factors in patients with type 2 diabetes mellitus |
MS212482 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: We carried out a prospect i ve , r and omised controlled trial on two groups of 40 patients with painful calcific tendonitis and a mean age of 48.4 years ( 32.5 to 67.3 ) . All were to undergo arthroscopic removal of the calcific deposit within six months after r and omisation . The 40 patients in group I received ultrasound-guided needling followed by high-energy shock-wave therapy and the 40 in group II had shock-wave therapy alone . In both groups one treatment consisting of 2500 impulses of shock waves with an energy flux density of 0.36 mJ/mm(2 ) was applied . The clinical and radiological outcome was assessed using the 100-point Constant shoulder scoring system and st and ardised radiographs . The mean follow-up was 4.1 months and no patient was lost to follow-up . Both groups had significant improvement in their Constant shoulder score . Radiographs showed disappearance of the calcific deposit in 60.0 % of the shoulders in group I and in 32.5 % of group II ( p < 0.05 ) . Significantly better clinical and radiological results were obtained in group I than in group II . Arthroscopic removal of the deposit was avoided in 32 patients of group I and in 22 of group II . No severe side-effects were recorded . Ultrasound-guided needling in combination with high-energy shock-wave therapy is more effective than shock-wave therapy alone in patients with symptomatic calcific tendonitis , giving significantly higher rates of elimination of the calcium deposits , better clinical results and reduction in the need for surgery BACKGROUND Knowledge about Minimal Important Differences ( MIDs ) is essential for the interpretation of continuous outcomes , especially patient-reported outcome measures ( PROMS ) . OBJECTIVE The aim of this study was to estimate the MID for the Western Ontario Rotator Cuff Index ( WORC : score 0 ( best ) to 2100 ( worst disability ) ) in adults with shoulder pain associated with partial-thickness rotator cuff tears , ' symptomatic PTTs ' , undergoing conservative treatment with physiotherapy . DESIGN A prospect ively- design ed anchor-based MID analysis using data from a prospect i ve prognostic study with a three-month follow-up conducted within an outpatient care setting in Germany . METHODS The MID was estimated using data from 64 adults with atraumatic symptomatic PTTs who underwent three months of conservative treatment with physiotherapy . The anchor was a seven-point Global Perceived Change ( GPC ) scale . RESULTS Based on a definition of the MID being the threshold of " being ( at least slightly ) improved " with a probability nearest to 0.90 ( i.e. 9 of 10 patients achieving the MID ) , the MID for the WORC was estimated as -300 for ' improved ' shoulder-related disability in 9 out of 10 patients ( 95 % CI 8 out of 10 patients to everyone ) undergoing three months of exercise-based physiotherapy for symptomatic PTTs . CONCLUSIONS This is the first published MID estimate for the WORC in adults with symptomatic PTTs of the rotator cuff undergoing typical treatment comprising conservative treatment with physiotherapy . The conceptual framework for interpretation facilitates its use in similar clinical context Background : Barbotage ( needling and lavage ) is often applied in the treatment of calcific tendinitis of the rotator cuff ( RCCT ) . In a previously published r and omized controlled trial , we reported superior clinical and radiological 1-year outcomes for barbotage combined with a corticosteroid injection in the subacromial bursa ( SAIC ) compared with an isolated SAIC . There are no trials with a midterm or long-term follow-up of barbotage available . Purpose : To compare the 5-year results of 2 regularly applied treatments of RCCT : ultrasound (US)–guided barbotage combined with a SAIC ( group 1 ) versus an isolated US-guided SAIC ( group 2 ) . Study Design : R and omized controlled trial ; Level of evidence , 1 . Methods : Patients were r and omly assigned to group 1 or 2 and evaluated before and after treatment at regular time points until 12 months and also at 5 years using the Constant score ( CS ) , the Western Ontario Rotator Cuff Index ( WORC ) , and the Disabilities of the Arm , Shoulder and H and ( DASH ) . The calcification location and size and Gärtner classification were assessed on radiographs . The rotator cuff condition was evaluated with US . Results were analyzed using t tests , linear regression , and a mixed model for repeated measures . Results : Forty-eight patients were included ( mean age , 52.0 ± 7.3 years ; 25 [ 52 % ] female ) with a mean baseline CS of 68.7 ± 11.9 . After a mean follow-up of 5.1 ± 0.5 years , the mean CS was 90 ( 95 % CI , 83.0 - 95.9 ) in group 1 versus 87 ( 95 % CI , 80.5 - 93.5 ) in group 2 ( P = .58 ) . The mean improvement in the CS in group 1 was 18 ( 95 % CI , 12.3 - 23.0 ) versus 21 ( 95 % CI , 16.2 - 26.2 ) in group 2 ( P = .32 ) . There was total resorption in 62 % of group 1 and 73 % of group 2 ( P = .45 ) . The US evaluation of the rotator cuff condition showed no significant differences between the groups . With the mixed model for repeated measures , taking into account the baseline CS and Gärtner classification , the mean treatment effect for barbotage was 6 ( 95 % CI , –8.9 to 21.5 ) , but without statistical significance . Follow-up scores were significantly associated with baseline scores and the duration of follow-up . Results for the DASH and WORC were similar . There were no significant complications , but 4 patients in group 1 and 16 in group 2 underwent additional treatment during the follow-up period ( P < .001 ) . Conclusion : No more significant differences were found in the clinical and radiological outcomes between barbotage combined with a SAIC versus an isolated SAIC after 5 years of follow-up . Registration : NTR2282 ( Dutch Trial Registry ) OBJECTIVE Calcific tendonitis of rotator cuff is observed on plain radiographs in 10 % of adults , but remains asymptomatic in half these cases . We looked for differences on ultrasound ( US ) and power Doppler findings between symptomatic and asymptomatic cases of shoulder calcific tendonitis . METHODS US was performed in 62 patients ( 81 shoulders ) with symptomatic ( n=57 ) or asymptomatic ( n=24 ) calcific tendonitis . Calcific plaque morphology , power Doppler signaling , and widening of the subacromial-subdeltoid bursa ( SSB ) were recorded . US-guided steroid injection into the SSB ( n=21 ) or needle puncture of calcific deposits ( n=29 ) was performed at the end of US evaluation in 50 of the 57 patients , and a question naire was sent to each patient after 11+/-6 months . RESULTS Larger ( p=0.0015 ) and fragmented ( p=0.01 ) calcifications were associated with pain . A power Doppler signal and a widening of the SSB was identified in 21 and 17 of the 57 symptomatic calcification respectively , but in none of the cases of asymptomatic calcification ( p<0,005 ) . At least one of these signs was present in 31 of the 57 ( 54 % ) symptomatic shoulders ( p<0.001 ) . Long-term outcome was favourable for 60 % of our patients after steroid injection . The presence of a SSB widening before bursal steroid injection was associated with an improvement of the symptoms ( p=0.06 ) . CONCLUSION Positive power Doppler signal within the calcific deposit and SSB widening are US features strongly associated with pain . Moreover , larger calcifications are also more symptomatic . According to these results , US can help physicians to confirm that calcification is responsible for shoulder pain BACKGROUND Extracorporeal shockwave treatment ( ESWT ) and ultrasound-guided percutaneous lavage ( UGPL ) are two effective ways of treating rotator cuff calcific tendinopathy ( RCCT ) . AIM The aim of the present study was to compare the effectiveness of these techniques in the treatment of RCCT . DESIGN Prospect i ve , r and omized , controlled trial . SETTING Patients treated in our sports medicine and rehabilitation center ( Centro Médico Deyre , Madrid . Spain ) between January 2007 and December 2013 . METHODS This r and omized study compares the results achieved with these techniques over one year following their use to treat the above condition . Eighty patients received ESWT and 121 received UGPL . A visual analogue scale was used to measure pain , and ultrasound to determine the extent of calcification , at 3 , 6 , and 12 months after treatment . RESULTS Pain and the amount of calcification were significantly reduced by both techniques at 3 , 6 and 12 months ( P<0.001 for each ) , but significantly more so by UGPL ( P<0.001 ) . CONCLUSIONS Both techniques are valid for the treatment of RCCT , although UGPL is associated with a greater reduction of calcification and greater reduction in pain . CLINICAL REHABILITATION IMPACT The results obtained applying UGPL , the low cost and the lack of complications should therefore make the treatment of choice in centers that are appropriately equipped and staffed HYPOTHESIS Ultrasound (US)-guided needling with subacromial corticosteroid injection is more effective than extracorporeal shock wave therapy ( ESWT ) for function restoration and pain relief in patients with calcific tendinitis of the shoulder . METHODS Fifty-four patients diagnosed with unilateral painful calcific tendinitis were r and omly allocated to a US needling or ESWT group . The US needling group underwent US-guided needling and received a subacromial corticosteroid injection . The ESWT group received ESWT 3 times a week . All patients were prospect ively evaluated ; American Shoulder and Elbow Surgeons , Simple Shoulder Test , and visual analog scale for pain scores were recorded before the procedure and at 6 weeks , 12 weeks , 6 months , 12 months , and the last follow-up . The size and morphology of the deposits were evaluated by radiography . RESULTS The average follow-up period was 23.0 months . At last follow-up , the mean size of the deposits was significantly different between the 2 groups ( P = .001 ) ; it decreased to 0.5 mm from 14.8 mm in the US needling group and to 5.6 mm from 11.0 mm in the ESWT group . There were also significant improvements in clinical outcomes in both groups after treatment ( P < .05 ) . At 1-year follow-up , the US needling group had significantly better scores than the ESWT group with regard to the American Shoulder and Elbow Surgeons assessment ( 90.3 and 74.6 , respectively ; P = .001 ) , Simple Shoulder Test ( 83.3 and 70.8 , respectively ; P = .015 ) , and visual analog scale for pain ( 1.4 and 3.3 , respectively ; P = .003).The initial calcium deposit sizes and clinical outcomes were weakly correlated in both groups ( P > .05 ) . CONCLUSION Both treatment modalities for calcific tendinitis improved clinical outcomes and eliminated calcium deposits . US-guided needling treatment , however , was more effective in function restoration and pain relief in the short term BACKGROUND The minimal clinical ly important difference ( MCID ) is increasingly used to evaluate treatment effectiveness . The MCID for the Constant score has not been previously reported . MATERIAL S AND METHODS A prospect ively collected cohort of 802 consecutive shoulders with arthroscopically treated partial- or full-thickness rotator cuff tears was analyzed . The Constant score was measured preoperatively and at 3 months and 1 year postoperatively . At follow-up visits , the patients were asked a simple 2-stage question : Is the shoulder better or worse after the operation compared with the preoperative state ? This single 2-level question was used as an indicator of patient satisfaction and as an anchor to calculate the MCID for the Constant score . RESULTS At 1 year , 781 ( 97.4 % ) patients ( 474 men , 307 women ) were available for follow-up . The preoperative Constant score was 53.1 ( SD 17.2 ) in all patients , 56.2 ( SD 17.4 ) in male patients , and 48.2 ( SD 15.6 ) in female patients . Postoperatively at 3 months , the scores were 61.7 ( SD 16.4 ) in all patients , 65.1 ( SD 16.1 ) in male patients , and 56.8 ( SD 15.5 ) in female patients . At 1 year , the scores were 75.9 ( SD 15.2 ) in all patients , 79.0 ( SD 14.9 ) in male patients , and 71.0 ( SD 14.3 ) in female patients . At 3 months postoperatively , 92.2 % of male patients and 87.2 % of female patients were satisfied with the outcome ( P = .027 ) ; at 1 year , the satisfaction was 93.2 % and 89.5 % , respectively ( P = .067 ) . Five different statistical approaches yielded 5 different MCID estimates ( range , 2 - 16 ) . The 3-month mean change estimate of MCID was 10.4 points . CONCLUSION Our study demonstrates an MCID estimate of 10.4 points as the
Output:
| Conclusion For individuals with rotator cuff calcific tendinopathy , low- quality evidence suggests that ultrasound-guided lavage is more effective than shockwave therapy or a corticosteroid injection alone . |
MS212483 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background To assess whether the Multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus ( RAMP-DM ) led to improvements in biomedical outcomes , observed cardiovascular events and predicted cardiovascular risks after 12-month intervention in the primary care setting . Methods A r and om sample of 1,248 people with diabetes enrolled to RAMP-DM for at least 12 months was selected and 1,248 people with diabetes under the usual primary care were matched by age , sex , and HbA1c level at baseline as the usual care group . Biomedical and cardiovascular outcomes were measured at baseline and at 12-month after the enrollment . Difference-in-differences approach was employed to measure the effect of RAMP-DM on the changes in biomedical outcomes , proportion of subjects reaching treatment targets , observed and predicted cardiovascular risks . Results Compared to the usual care group , RAMP-DM group had lower cardiovascular events incidence ( 1.21 % vs 2.89 % , P = 0.003 ) , and net decrease in HbA1c ( −0.20 % , P < 0.01 ) , SBP ( −3.62 mmHg , P < 0.01 ) and 10-year cardiovascular disease ( CVD ) risks ( total CVD risk , −2.06 % , P < 0.01 ; coronary heart disease ( CHD ) risk , −1.43 % , P < 0.01 ; stroke risk , −0.71 % , P < 0.01 ) . The RAMP-DM subjects witnessed significant rises in the proportion of reaching treatment targets of HbA1c , and SBP/DBP . After adjusting for confounding variables , the significance remained for HbA1c , predicted CHD and stroke risks . Conclusions The RAMP-DM result ed in greater improvements in HbA1c and reduction in observed and predicted cardiovascular risks at 12 months follow-up , which indicated a risk-stratification multidisciplinary intervention was an effective strategy for managing Chinese people with diabetes in the primary care setting .Trial registry Clinical Trials.gov , OBJECTIVE To evaluate the accuracy of the UK Prospect i ve Diabetes Study Outcomes Model ( UKPDS-OM ) in predicting clinical outcomes during the UKPDS posttrial monitoring ( PTM ) period . RESEARCH DESIGN AND METHODS At trial end in 1997 , the 4,031 surviving UKPDS patients , of the 5,102 originally enrolled in the study , returned to their usual care providers , with no attempts made to maintain them in their r and omized therapy groups . PTM risk factor data were collected for 5 years and clinical outcome data for 10 years . The UKPDS-OM was used firstly to forecast likely progression of HbA1c , systolic blood pressure , total-to-HDL cholesterol ratio , and smoking status and secondly to estimate the likely first occurrence of seven major diabetes-related complications or death from any cause . Model predictions were compared against observed PTM data for risk factor time paths and survival probabilities for major diabetes complications . RESULTS UKPDS-OM – forecasted risk factor time paths were similar to those observed for HbA1c ( up to 3 years ) and total-to-HDL cholesterol ratio but underestimated for systolic blood pressure and smoking status . Predicted 10-year event probabilities were similar to those observed for blindness , ischemic heart disease , myocardial infa rct ion , and renal failure but were higher for heart failure and death from any cause and lower for stroke and amputation . CONCLUSIONS The UKPDS-OM has good predictive accuracy for two of four risk factor time paths and for 10-year clinical outcome probabilities with the exception of stroke , amputation , heart failure , and death from any cause . An up date d version of the model incorporating PTM data is being developed Summary A total of 6695 diabetic men and women , aged 35 to 54 years , from 14 centres and representing 13 national groups , participated in a vascular disease prevalence survey . A r and om sample was drawn after stratification of each centre 's diabetic base population by sex , duration of diabetes and age . A common agreed protocol , st and ardized examination procedures , and central ized laboratory methods were used in the investigation . Within the age range examined there was considerable variation between centres in a number of variables , including degree of obesity ( measured as Body Mass Index ( BMI ) ) , proportion treated with insulin and proportion of cigarette smokers . The latter also showed considerable sex differences within centres . Subjects with age at onset below 25 years were notably few in Hong Kong , Tokyo and Oklahoma . There was also considerable variation in the apparent prevalence of both large- and small-vessel ( macrovascular and microvascular ) disease between centres . In pooled data , measures of large-vessel disease were significantly and independently associated with age , blood pressure and BMI in both sexes , and with diabetes duration and plasma cholesterol in men only . Within-centre analyses showed blood pressure to be the most consistently associated variable in both sexes . In pooled data , small-vessel disease of the eye was significantly and independently associated with diabetes duration , blood pressure , BMI and type of treatment in both sexes . In within-centre analyses , diabetes duration was the most consistently associated variable , followed by blood pressure . Proteinuria as an index of small-vessel disease of the kidney was , in pooled data , significantly and independently correlated with diabetes duration , blood pressure and plasma cholesterol in both sexes . In within-centre analyses , blood pressure was the most consistently associated variable , with diabetes duration and plasma cholesterol equal second -significant in 12 of the 28 centre/sex groups . Heterogeneity of large-vessel disease prevalence in diabetic subjects is confirmed by this study , and the possibility of heterogeneity in small-vessel disease prevalence and severity is suggested Introduction . The objective of this study was to create a tool that accurately predicts the risk of morbidity and mortality in patients with type 2 diabetes according to an oral hypoglycemic agent . Material s and Methods . The model was based on a cohort of 33,067 patients with type 2 diabetes who were prescribed a single oral hypoglycemic agent at the Clevel and Clinic between 1998 and 2006 . Competing risk regression models were created for coronary heart disease ( CHD ) , heart failure , and stroke , while a Cox regression model was created for mortality . Propensity scores were used to account for possible treatment bias . A prediction tool was created and internally vali date d using tenfold cross-validation . The results were compared to a Framingham model and a model based on the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) for CHD and stroke , respectively . Results and Discussion . Median follow-up for the mortality outcome was 769 days . The numbers of patients experiencing events were as follows : CHD ( 3062 ) , heart failure ( 1408 ) , stroke ( 1451 ) , and mortality ( 3661 ) . The prediction tools demonstrated the following concordance indices ( c-statistics ) for the specific outcomes : CHD ( 0.730 ) , heart failure ( 0.753 ) , stroke ( 0.688 ) , and mortality ( 0.719 ) . The prediction tool was superior to the Framingham model at predicting CHD and was at least as accurate as the UKPDS model at predicting stroke . Conclusions . We created an accurate tool for predicting the risk of stroke , coronary heart disease , heart failure , and death in patients with type 2 diabetes . The calculator is available online at http://rcalc.ccf.org under the heading “ Type 2 Diabetes ” and entitled , “ Predicting 5-Year Morbidity and Mortality . ” This may be a valuable tool to aid the clinician ’s choice of an oral hypoglycemic , to better inform patients , and to motivate dialogue between physician and patient OBJECTIVE We sought to vali date Risk Equations for Complications of Type 2 Diabetes ( RECODe ) among diverse population s. RESEARCH DESIGN AND METHODS We compared risk predictions from RECODe equations and from two alternative risk models ( UK Prospect i ve Diabetes Study Outcomes Model 2 [ UKPDS OM2 ] and American College of Cardiology/American Heart Association Pooled Cohort Equations ) to observed outcomes in two studies : the Multi-Ethnic Study of Atherosclerosis ( MESA , n = 1,555 adults with type 2 diabetes , median follow-up 9.1 years ) and the Jackson Heart Study ( JHS , n = 1,746 adults with type 2 diabetes , median follow-up 8.0 years ) . Outcomes included nephropathy by multiple measures ( microalbuminuria , macroalbuminuria , renal failure , end-stage renal disease , and reduction in glomerular filtration rate ) , moderate to severe diabetic retinopathy by Airlie House classification , fatal or nonfatal myocardial infa rct ion , fatal or nonfatal stroke , congestive heart failure , and all-cause mortality . RESULTS RECODe equations for microvascular and cardiovascular outcomes had C-statistics for discrimination ranging from 0.71 to 0.85 in MESA and 0.64 to 0.91 in JHS for alternative outcomes . Calibration slopes in MESA ranged from 0.62 for a composite nephropathy outcome , 0.83–1.04 for individual nephropathy outcomes , 1.07 for retinopathy , 1.00–1.05 for cardiovascular outcomes , and 1.03 for all-cause mortality . Slopes in JHS ranged from 0.47 for retinopathy , 0.97–1.16 for nephropathy , 0.72–1.05 for cardiovascular outcomes , and 1.01 for all-cause mortality . The alternative models had C-statistics 0.50–0.72 and calibration slopes 0.07–0.60 . CONCLUSIONS RECODe equations improved risk estimation for diverse patients with type 2 diabetes , as compared with two commonly used alternatives Objective To develop and vali date version two of the QRISK cardiovascular disease risk algorithm ( QRISK2 ) to provide accurate estimates of cardiovascular risk in patients from different ethnic groups in Engl and and Wales and to compare its performance with the modified version of Framingham score recommended by the National Institute for Health and Clinical Excellence ( NICE ) . Design Prospect i ve open cohort study with routinely collected data from general practice , 1 January 1993 to 31 March 2008 . Setting 531 practice s in Engl and and Wales contributing to the national Q RESEARCH data base . Participants 2.3 million patients aged 35 - 74 ( over 16 million person years ) with 140 000 cardiovascular events . Overall population ( derivation and validation cohorts ) comprised 2.22 million people who were white or whose ethnic group was not recorded , 22 013 south Asian , 11 595 black African , 10 402 black Caribbean , and 19 792 from Chinese or other Asian or other ethnic groups . Main outcome measures First ( incident ) diagnosis of cardiovascular disease ( coronary heart disease , stroke , and transient ischaemic attack ) recorded in general practice records or linked Office for National Statistics death certificates . Risk factors included self assigned ethnicity , age , sex , smoking status , systolic blood pressure , ratio of total serum cholesterol : high density lipoprotein cholesterol , body mass index , family history of coronary heart disease in first degree relative under 60 years , Townsend deprivation score , treated hypertension , type 2 diabetes , renal disease , atrial fibrillation , and rheumatoid arthritis . Results The validation statistics indicated that QRISK2 had improved discrimination and calibration compared with the modified Framingham score . The QRISK2 algorithm explained 43 % of the variation in women and 38 % in men compared with 39 % and 35 % , respectively , by the modified Framingham score . Of the 112 156 patients classified as high risk ( that is , ≥20 % risk over 10 years ) by the modified Framingham score , 46 094 ( 41.1 % ) would be reclassified at low risk with QRISK2 . The 10 year observed risk among these reclassified patients was 16.6 % ( 95 % confidence interval 16.1 % to 17.0%)—that is , below the 20 % treatment threshold . Of the 78 024 patients classified at high risk on QRISK2 , 11 962 ( 15.3 % ) would be reclassified at low risk by the modified Framingham score . The 10 year observed risk among these patients was 23.3 % ( 22.2 % to 24.4%)—that is , above the 20 % threshold . In the validation cohort , the annual incidence rate of cardiovascular events among those with a QRISK2 score of ≥20 % was 30.6 per 1000 person years ( 29.8 to 31.5 ) for women and 32.5 per 1000 person years ( 31.9 to 33.1 ) for men . The corresponding figures for the modified Framingham equation were 25.7 per 1000 person years ( 25.0 to 26.3 ) for women and 26.4 ( 26.0 to 26.8 ) for men ) . At the 20 % threshold , the population identified by
Output:
| Overall , the performance of these diabetes-specific stroke prediction models was not satisfactory . |
MS212484 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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***EXAMPLES***
Input: Indirect evidence is accumulating for an association between antibiotic use , especially in early childhood , and long-term immunologic health . The authors evaluated the association between antibiotic use in childhood and subsequent development of type 1 diabetes . A nationwide cohort study of all Danish singleton children born during 1995 - 2003 ( n = 606,420 ) was conducted . Incidence rate ratios for type 1 diabetes comparing children according to antibiotic use were estimated . Antibiotic use was classified according to class , number of uses , and age at use . Use of any antibiotic was not associated with type 1 diabetes ( rate ratio = 1.16 , 95 % confidence interval : 0.91 , 1.50 ) . Evaluation of type 1 diabetes risk according to number of courses of any antibiotic yielded no association between antibiotic use and type 1 diabetes , with an increase in rate ratio per course of 1.02 ( 95 % confidence interval : 0.97 , 1.07 ) . No specific class of antibiotics was associated with type 1 diabetes , no specific age of use was associated with type 1 diabetes , and no specific age at onset of type 1 diabetes was associated with antibiotics . In a large nationwide prospect i ve study , no association between antibiotic use and type 1 diabetes was found among Danish children OBJECTIVES To apply an institutional clinical data warehouse ( CDW ) to the assessment of adverse drug reactions ( ADRs ) and demonstrate its utility through a specific example . METHODS We modeled the process for assessing ADRs through retrospective cohort design by using CDW at the Osaka University Hospital as follows : 1 ) We defined a drug X , an adverse drug reaction ( ADR ) Y , and a laboratory measurement Z to assess Y during a given study period ; 2 ) we excluded those whose Z value exceeded the defined criteria or were not available at the inception of the cohort ; 3 ) we divided the patients into two groups based on exposure or non-exposure to X ; 4 ) we matched the patient characteristics between the two groups through stratification and r and omization ; and 5 ) we compared the frequency of patients who presented Y during the study period between the two groups . Aminoglycoside and Cephalosporin associated nephrotoxicity in pediatric in patients was used as an example to demonstrate the usefulness of this approach . RESULTS Our evaluation indicates that there is an increased risk of nephrotoxicity for pediatric in patients who were prescribed cephalosporin either alone or in combination with aminoglycoside ; further , aminoglycoside tends to increase the cephalosporin-associated nephrotoxicity . CONCLUSIONS Our findings are consistent with those drawn from other studies , indicating that the method of applying an institutional CDW is useful for assessing ADRs BACKGROUND The Oka strain of live attenuated varicella virus was licensed for use in healthy children in the United States in March , 1995 . We report a postmarketing evaluation of the short term safety of this vaccine within Kaiser Permanente . METHODS After licensure varicella vaccination was introduced into the preventive care program of the Northern California Kaiser Permanente Medical Care Program . Potential adverse events after vaccination with varicella vaccine were identified from automated clinical data bases of hospitalizations , emergency room visits and clinic visits . Deaths were identified from automated clinical data bases at Kaiser as well as from the State death records for California . To evaluate safety , rates of diagnosis-specific events in the risk periods were compared with the rates of such diagnosis-specific events in two self control and one historical control period . RESULTS During the study period of April 1 , 1995 , to December 31 , 1996 , a total of 89753 adults and children received varicella vaccine . A total of 3200 relative risks were calculated , and of these 5 hospital diagnostic categories , 9 emergency visit diagnostic categories and 30 outpatient diagnostic categories demonstrated at least 1 relative risk with a P value of < 0.05 in 1 or more age groups and in comparisons with 1 control period or more . The p value for these tests was not adjusted for multiple comparisons . Of these categories 14 demonstrated an increased risk either in more than 1 age group or against more than 1 comparison group . These categories included elective procedures , febrile seizure , febrile illness , well child , acute gastroenteritis , varicella , congenital anomaly , " rule out sepsis , " trauma , viral syndrome , apnea , back pain , congenital valvular heart disease and vision evaluation for glasses . Of these the outcomes of elective procedure , congenital anomaly , congenital valvular heart disease , well child and vision evaluation for glasses were judged not to have a biologically plausible association with vaccination . A second diagnostic grouping included febrile illness , viral illness , febrile seizure and " rule out sepsis . " In an analysis of these events which adjusted for the concomitant administration of M-M-R(II ) vaccine , none of the associations was statistically associated with receipt of varicella vaccine . The diagnostic category of " rule out sepsis " still had a relative risk of 1.95 with P = 0.02 . None of the children in the " rule out sepsis " category had positive bacteriologic cultures from any other normally sterile site . Because of the large number of gastroenteritis cases , we review ed a r and om sample of 100 exposed and 100 unexposed cases . From this review no consistent time association or clustering of any of these events was seen in the exposed follow-up time interval . Only gastroenteritis and negative evaluations for sepsis were thought to be possibly associated with receipt of varicella vaccine . Although there was a statistically significant increased risk over the entire 30 day-period , there was no clustering of these events within the 30-day window . CONCLUSION In this study population of 89753 children and adults , the varicella vaccine ( Oka strain , Merck ) appeared to have a favorable safety profile . In addition rates of varicella-like rash and of breakthrough cases were both low and consistent with the rates observed in prelicensure studies From the early 1990s infants started to receive acellular pertussis vaccine combined with diphtheria and tetanus toxoids ( DTaP ) before live vaccines such as measles , rubella , and mumps vaccines , which contained gelatin as a stabilizer . Then , an increasing number of cases of anaphylactic/allergic reactions to those live vaccines were reported . Almost all these cases had a previous history of receiving three or four doses of DTaP containing gelatin . Anaphylactic/allergic reactions to live measles vaccine were analyzed using information obtained from the Reporting System , a retrospective study , as well as from the Monitoring System , a prospect i ve study . Dramatic decreases in anaphylactic/allergic reactions to live measles vaccines were observed immediately after each manufacturer marketed gelatin-free or gelatin (hypo-allergic)-containing live measles vaccine , and since the end of 1998 reports on anaphylactic/allergic reactions to live measles vaccine have almost ceased BACKGROUND The ongoing debate on the incidence and types of iatrogenic injuries in American hospitals has been informed primarily by the Harvard Medical Practice Study , which analyzed hospitalizations in New York in 1984 . The generalizability of these findings is unknown and has been question ed by other studies . OBJECTIVE We used methods similar to the Harvard Medical Practice Study to estimate the incidence and types of adverse events and negligent adverse events in Utah and Colorado in 1992 . DESIGN AND SUBJECTS We selected a representative sample of hospitals from Utah and Colorado and then r and omly sample d 15,000 nonpsychiatric 1992 discharges . Each record was screened by a trained nurse- review er for 1 of 18 criteria associated with adverse events . If > or = 1 criteria were present , the record was review ed by a trained physician to determine whether an adverse event or negligent adverse event occurred and to classify the type of adverse event . MEASURES The measures were adverse events and negligent adverse events . RESULTS Adverse events occurred in 2.9+/-0.2 % ( mean+/-SD ) of hospitalizations in each state . In Utah , 32.6+/-4 % of adverse events were due to negligence ; in Colorado , 27.4+/-2.4 % . Death occurred in 6.6+/-1.2 % of adverse events and 8.8+/-2.5 % of negligent adverse events . Operative adverse events comprised 44.9 % of all adverse events ; 16.9 % were negligent , and 16.6 % result ed in permanent disability . Adverse drug events were the leading cause of nonoperative adverse events ( 19.3 % of all adverse events ; 35.1 % were negligent , and 9.7 % caused permanent disability ) . Most adverse events were attributed to surgeons ( 46.1 % , 22.3 % negligent ) and internists ( 23.2 % , 44.9 % negligent ) . CONCLUSIONS The incidence and types of adverse events in Utah and Colorado in 1992 were similar to those in New York State in 1984 . Iatrogenic injury continues to be a significant public health problem . Improving systems of surgical care and drug delivery could substantially reduce the burden of iatrogenic injury OBJECTIVE Pediatric interventional radiologists are frequently challenged when faced with organ biopsies . Because of the need for patient immobility and the potential risk of morbidity with patient movement during biopsies , many radiologists prefer general anesthesia to sedation . We present our experience with radiologist-supervised ketamine sedation in pediatric patients undergoing renal and hepatic biopsies . MATERIAL S AND METHODS Quality assurance data were accessed from a computerized data base that prospect ively collects demographics , outcome parameters , and adverse events on all patients who receive ketamine sedation . Patients received an IV ketamine bolus of 2 mg/kg followed by a continuous infusion of ketamine of up to 150 mcg/kg/min titrated to the responsiveness of the patient . RESULTS Sixty-five children received ketamine for liver ( n = 35 ) and renal ( n = 30 ) biopsies . The mean age of the study group was 7.0 + /- 2.7 ( SD ) years . The cohort included patients with an American Society of Anesthesiologists ( ASA ) physical status classification of ASA 1 ( 3 % ) , ASA 2 ( 78 % ) , and ASA 3 ( 19 % ) . The duration of ketamine sedation averaged 39 + /- 20 ( SD ) minutes , with an average procedure time of 32 + /- 19 ( SD ) minutes . All procedures were successfully completed , and there were no major adverse events . CONCLUSION Interventional radiologists performing solid organ biopsies in the pediatric population often use general anesthesia to ensure immobility , adequate analgesia , and safe conditions . Our experience suggests that interventional radiologists may supervise a nurse-administered ketamine protocol to provide safe , effective analgesia and sedation for liver and renal biopsies UNLABELLED Recent reports out of Japan have linked therapeutic use of the oral neuraminidase inhibitor oseltamivir with adverse neuropsychiatric outcomes in adolescents . OBJECTIVE To assess if protective measures should be taken to mitigate potential adverse outcomes among United States Department of Defense ( DoD ) pediatric beneficiaries who are prescribed oseltamivir therapeutically . STUDY GROUP DoD healthcare beneficiaries , ages 1 through 21 years , who received a diagnosis of influenza from 1 October 2006 through 30 September 2007 . METHODS A retrospective cohort study using electronic healthcare service and pharmacy fill . Cross tabulations and propensity-adjusted logistic regression analyses were performed to compare the frequency of adverse neuropsychiatric outcomes among those treated therapeutically with oseltamivir with those that were not . RESULTS The prevalences of neuropsychiatric diagnoses following the influenza diagnosis overall and among the treated and untreated groups were 3.5 % , 3.0 % , and 3.8 % , respectively ( p < .05 ) . A statistically significant protective effect was associated with oseltamivir treatment ( prevalence odds ratio ( POR ) = 0.82 ( 95 % CI , 0.69 , 0.96 ) ) in a propensity-adjusted regression model . The model significantly associated increasing patient age with the likelihood of an adverse neuropsychiatric outcome , but the associations with patient gender and parental rank , a proxy used for socioeconomic status , were not statistically Significant . CONCLUSIONS Our retrospective study found no evidence that oseltamivir treatment for influenza increased the risk of adverse neuropsychiatric outcomes among the study population . An additional study focusing on prospect i ve medical surveillance of influenza patients is warranted A retrospective cohort design of Medicaid medical and pharmacy cl aims for 1996 through 2005 was employed for 14 171 children and adolescents prescribed an antidepressant medication and a r and om sample of 4500 children not treated with any class of psychotropic medication to compare the prevalence rates of cardiovascular and neurological adverse events . The treated cohort evinced a higher prevalence of cardiovascular events , orthostatic hypotension , seizures , insomnia ,
Output:
| Multi-system reactions were most commonly studied , followed by central nervous system and mental and behavioural disorders .
Vaccines were most frequently prescribed followed by corticosteroids , general anaesthetics and antidepressants .
CONCLUSIONS Routine electronic healthcare records were increasingly reported to be used for pharmacovigilance in children . |
MS212485 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Of all older patients that opt for elective colorectal surgery , approximately one-third has one or more postoperative complications , particularly those patients with a low cardiorespiratory fitness ( ventilatory anaerobic threshold ( VAT ) < 11 mL/kg/min ) . A physical exercise training program prior to surgery ( prehabilitation ) can improve their cardiorespiratory fitness . It remains to be seen whether prehabilitation also reduces postoperative complications , as most of the studies so far were rather underpowered , heterogeneous , and biased toward selection of patients with a lower risk of postoperative complications . The primary objective of this study is to evaluate the effects of a three-week prehabilitation program on 30-day postoperative complications in patients with a VAT < 11 mL/kg/min planned for elective colorectal resection for colorectal cancer or dysplasia . Methods In this multicenter prospect i ve r and omized controlled trial , patients ≥ 60 years with colorectal cancer or dysplasia grade I , II , or III , planned for elective colorectal resection in two hospitals in the Netherl and s , will be recruited . Eligible patients must have a score ≤ 7 metabolic equivalents on the veterans-specific activity question naire , and should be able to perform a cardiopulmonary exercise test . A total of 86 patients will be r and omized ( block-stratified r and omization ) to prehabilitation ( intervention group ) or usual care ( control group ) . For final inclusion , VAT should be < 11 mL/kg/min . Three times a week for 3 weeks , a 60-min supervised prehabilitation session will be completed in community physical therapy practice s by the 43 patients in the prehabilitation group , consisting of moderate-to-high intensity interval training to improve cardiorespiratory fitness , and resistance training to improve peripheral muscle strength . Additionally , patients perform home exercises twice a week on a moderate intensity level . The 43 patients in the usual care group will receive usual care . Discussion Optimizing preoperative physical fitness may decrease the postoperative complication rate , may lead to fewer reoperations , less intense clinical care , a shorter length of stay , a more effective surgical planning ( process-optimization ) , fewer readmissions , less intense rehabilitation , shorter rehabilitation period , earlier resumption of work , enhance patient perceived health-related quality of life , and promote performance in daily life . Cost-effectiveness should therefore be expected and evaluated . Trial registration Medical Ethics Committee Twente , Enschede , the Netherl and s ( NL45001.044.13 , September 3 , 2013 ) ; Netherl and s Trial Register ( NTR ; NTR4032 , June 14 , 2013 ) CONTEXT Postoperative pulmonary complications ( PPCs ) after coronary artery bypass graft ( CABG ) surgery are a major source of morbidity and mortality , and increase length of hospital stay and re source utilization . The prehospitalization period before CABG surgery may be used to improve a patient 's pulmonary condition . The efficacy of preoperative inspiratory muscle training ( IMT ) in reducing the incidence of PPCs in high-risk patients undergoing CABG surgery has not yet been determined . OBJECTIVE To evaluate the prophylactic efficacy of preoperative IMT on the incidence of PPCs in high-risk patients scheduled for elective CABG surgery . DESIGN , SETTING , AND PATIENTS A single-blind , r and omized clinical trial conducted at the University Medical Center Utrecht , Utrecht , the Netherl and s , with enrollment between July 2002 and August 2005 . Of 655 patients referred for elective CABG surgery , 299 ( 45.6 % ) met criteria for high risk of developing PPCs , of whom 279 were enrolled and followed up until discharge from hospital . INTERVENTION Patients were r and omly assigned to receive either preoperative IMT ( n = 140 ) or usual care ( n = 139 ) . Both groups received the same postoperative physical therapy . MAIN OUTCOME MEASURES Incidence of PPCs , especially pneumonia , and duration of postoperative hospitalization . RESULTS Both groups were comparable at baseline . After CABG surgery , PPCs were present in 25 ( 18.0 % ) of 139 patients in the IMT group and 48 ( 35.0 % ) of 137 patients in the usual care group ( odds ratio [ OR ] , 0.52 ; 95 % confidence interval [ CI ] , 0.30 - 0.92 ) . Pneumonia occurred in 9 ( 6.5 % ) of 139 patients in the IMT group and in 22 ( 16.1 % ) of 137 patients in the usual care group ( OR , 0.40 ; 95 % CI , 0.19 - 0.84 ) . Median duration of postoperative hospitalization was 7 days ( range , 5 - 41 days ) in the IMT group vs 8 days ( range , 6 - 70 days ) in the usual care group by Mann-Whitney U statistic ( z = -2.42 ; P = .02 ) . CONCLUSION Preoperative IMT reduced the incidence of PPCs and duration of postoperative hospitalization in patients at high risk of developing a pulmonary complication undergoing CABG surgery . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N17691887 Background : As global initiatives increase patient access to surgical treatments , there remains a need to underst and the adverse effects of surgery and define appropriate levels of perioperative care . Methods : We design ed a prospect i ve international 7-day cohort study of outcomes following elective adult inpatient surgery in 27 countries . The primary outcome was in-hospital complications . Secondary outcomes were death following a complication ( failure to rescue ) and death in hospital . Process measures were admission to critical care immediately after surgery or to treat a complication and duration of hospital stay . A single definition of critical care was used for all countries . Results : A total of 474 hospitals in 19 high- , 7 middle- and 1 low-income country were included in the primary analysis . Data included 44 814 patients with a median hospital stay of 4 ( range 2–7 ) days . A total of 7508 patients ( 16.8 % ) developed one or more postoperative complication and 207 died ( 0.5 % ) . The overall mortality among patients who developed complications was 2.8 % . Mortality following complications ranged from 2.4 % for pulmonary embolism to 43.9 % for cardiac arrest . A total of 4360 ( 9.7 % ) patients were admitted to a critical care unit as routine immediately after surgery , of whom 2198 ( 50.4 % ) developed a complication , with 105 ( 2.4 % ) deaths . A total of 1233 patients ( 16.4 % ) were admitted to a critical care unit to treat complications , with 119 ( 9.7 % ) deaths . Despite lower baseline risk , outcomes were similar in low- and middle-income compared with high-income countries . Conclusions : Poor patient outcomes are common after inpatient surgery . Global initiatives to increase access to surgical treatments should also address the need for safe perioperative care . Study registration : IS RCT Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Surgical patients often show physiological and metabolic distress , muscle weakness , and long hospital stays . Physical conditioning might help recovery . We attempted to identify the most responsive measure of aerobic fitness from a four-week pre-surgical aerobic exercise program ( prehabilitation ) in patients undergoing major bowel resection . Twenty-one subjects r and omized two to one ( exercise : control ) scheduled for colorectal surgery . Fourteen subjects [ Body Mass Index ( BMI ) = 27 + /- 6 kg/m(2 ) ; maximal oxygen uptake ( VO(2max ) ) = 22 + /- 10 ml/kg/min ] underwent 3.8 + /- 1.2 weeks ( 27 + /- 8 sessions ) of progressive , structured pre-surgical aerobic exercise training at 40 to 65 % of heart rate reserve ( % HRR ) . Peak power output was the only maximal measure that was responsive to training [ 26 + /- 27 % , Effects Size ( ES ) = 0.24 ; St and ardized Response Mean ( SRM ) = 1.05 ; p < 0.05 ] . For the submaximal measures , heart rate and oxygen uptake during submaximal exercise was most responsive to training ( decrease by 13 % + /- 15 % , ES = -0.24 ; SRM = -0.57 ; and 7 % + /- 6 % , ES = -0.40 ; SRM -0.97 ; p < 0.05 ) at an exercise intensity of 76 + /- 47 W. There was no change to maximal or submaximal measures in the control group . The distance walked over six minutes improved in both groups ( by approximately 30 m ) , but the effect size and t-statistic were higher in the exercise group . Heart rate and oxygen uptake during submaximal exercise , and peak power output are the most responsive measures to four weeks of prehabilitation in subjects with low initial fitness Objective : The aim of this study was to assess the impact of personalized prehabilitation on postoperative complications in high-risk patients undergoing elective major abdominal surgery . Summary Background Data : Prehabilitation , including endurance exercise training and promotion of physical activity , in patients undergoing major abdominal surgery has been postulated as an effective preventive intervention to reduce postoperative complications . However , the existing studies provide controversial results and show a clear bias toward low-risk patients . Methods : This was a r and omized blinded controlled trial . Eligible c and i date s accepting to participate were blindly r and omized ( 1:1 ratio ) to control ( st and ard care ) or intervention ( st and ard care + prehabilitation ) groups . Inclusion criteria were : i ) age > 70 years ; and /or , ii ) American Society of Anesthesiologists score III/IV . Prehabilitation covered 3 actions : i ) motivational interview ; ii ) high-intensity endurance training ; and promotion of physical activity . The main study outcome was the proportion of patients suffering postoperative complications . Secondary outcomes included the endurance time ( ET ) during cycle-ergometer exercise . Results : We r and omized 71 patients to the control arm and 73 to intervention . After excluding 19 patients because of changes in the surgical plan , 63 controls and 62 intervention patients were included in the intention-to-treat analysis . The intervention group enhanced aerobic capacity [ & Dgr;ET 135 ( 218 ) % ; P < 0.001 ) , reduced the number of patients with postoperative complications by 51 % ( relative risk 0.5 ; 95 % confidence interval , 0.3–0.8 ; P = 0.001 ) and the rate of complications [ 1.4 ( 1.6 ) and 0.5 ( 1.0 ) ( P = 0.001 ) ] as compared with controls . Conclusion : Prehabilitation enhanced postoperative clinical outcomes in high-risk c and i date s for elective major abdominal surgery , which can be explained by the increased aerobic capacity BACKGROUND The aim of this study was to examine the outcomes of exercise therapy in patients with hepatocellular carcinoma who underwent hepatectomy . METHODS Fifty-one patients with hepatocellular carcinoma were r and omized to diet therapy alone ( n = 25 ) or to exercise in addition to diet therapy ( n = 26 ) . Exercise at the anaerobic threshold of each patient was started 1 month preoperatively , resumed from 1 week postoperatively , and continued for 6 months . RESULTS Whole body mass and fat mass in the exercise group compared with the diet group were significantly decreased at 6 months postoperatively . Fasting serum insulin and the homeostasis model assessment score were also significantly decreased . At 6 months , anaerobic threshold and peak oxygen consumption were significantly increased , while serum insulin and insulin resistance were significantly improved in a high-frequency exercise subgroup compared with a low-frequency group . CONCLUSIONS Perioperative exercise therapy for patients with hepatocellular carcinoma with liver dysfunction may improve insulin resistance associated with hepatic impairment and suggests a benefit to the early resumption of daily exercise after hepatectomy Background : The preoperative period ( prehabilitation ) may represent a more appropriate time than the postoperative period to implement an intervention . The impact of prehabilitation on recovery of function al exercise capacity was thus studied in patients undergoing colorectal resection for cancer . Methods : A parallel-arm single-blind superiority r and omized controlled trial was conducted . Seventy-seven patients were r and omized to receive either prehabilitation ( n = 38 ) or rehabilitation ( n = 39 ) . Both groups received a home-based intervention of moderate aerobic and resistance exercises , nutritional counseling with protein supplementation , and relaxation exercises initiated either 4 weeks before surgery ( prehabilitation ) or immediately after surgery ( rehabilitation ) , and continued for 8 weeks after surgery . Patients were managed with an enhanced recovery pathway . Primary outcome was functional exercise capacity measured using the vali date d 6-min walk test . Results : Median duration of pre
Output:
| Most studies included low-risk surgical patients and considerable variation was observed between prehabilitation programmes in terms of supervision , training context , frequency , intensity , duration and training type .
CONCLUSION : The content of prehabilitation programmes was heterogeneous .
Studies with a high therapeutic validity found unequivocal evidence that prehabilitation had beneficial effects on postoperative outcomes . |
MS212486 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Purpose The aim of this study was to compare the clinical efficacy of ultrasound-guided intra-articular injections of autologous platelet rich plasma ( PRP ) versus hyaluronic acid ( HA ) for symptomatic early osteoarthritis ( OA ) of the hip . Methods A prospect i ve controlled double-blinded r and omized trial on 80 patients with hip OA was conducted . The patients were divided in two groups of 40 patients each : group 1 underwent three PRP intra-articular ultrasound-guided injections , whereas group 2 underwent three HA injections . WOMAC , VAS , and Harris Hip Score were evaluated for both groups before and at 6 and 12 months after treatment . Results The two groups were comparable in age , sex , body mass index , and severity of hip OA . Both groups showed a significant improvement from baseline at 6-month and 12-month follow-ups for all the outcome measures . No major complications were observed during the treatment and at follow-ups in both the groups . Conclusion PRP did not offer significantly better results compared with HA in patients with moderate signs of OA , and thus it should not be considered as first-line treatment . Level of Evidence Level II , r and omized controlled trial Introduction Comparison of intra-articular bacterial-derived hyaluronic acid ( Hyalubrix ® ) ( HA ) with local analgesia ( mepivacaine ) for osteoarthritis ( OA ) of the hip . Methods A pilot prospect i ve , double-blind , 6-month r and omized trial of 42 patients with hip OA . HA or mepivacaine was administered twice ( once a month ) under ultrasound guidance . Efficacy measurements included the Lequesne 's algofunctional index , a visual analog scale for pain , concomitant use of analgesia , patient and physician global measurement , and safety . Results Patients in the HA group exhibited a significantly reduced Lequesne 's algofunctional index 3 and 6 months after treatment ( P < 0.001 ) and significantly reduced visual analog scale pain scores 3 and 6 months after treatment ( P < 0.05 ) compared with the local anesthetic group . All primary and secondary measures were significantly improved versus baseline , but other than the above were not different from each other at 3 or 6 months . Adverse effects were minimal . Conclusions This comparative study suggests a beneficial effect and safety of intra-articular HA in the management of hip OA.Trial registration numberIS RCT N39397064 Background To identify predictive factors of response to viscosupplementation ( VS ) in patients with hip osteoarthritis ( HOA ) . Methods Prospect i ve , multicentre , open-label trial , achieved in daily practice conditions . Patients with HOA were treated with a single intra-articular injection of a cross-linked hyaluronic acid combined with mannitol ( HAnox-M-XL ) , using imaging guidance . WOMAC pain and function scores and patient global assessment ( PGA ) were assessed at baseline and day 90 . Improvement , satisfaction and efficacy were self-assessed at day 90.Hip radiographs at baseline were scored using Kellgren-Lawrence grade and Osteoarthritis Research Society International ( OARSI ) score . Associations between clinical and radiological features and response to VS ( pain improvement > 50 % at day 90 ) were assessed in univariate analysis , and then using logistic regression , adjusted for confounding factors . Results The intent-to-treat ( ITT ) population included 97 patients ( 57 females , mean age 63 ) . Ninety completed the follow-up and 80 had full clinical and radiological data . Response to VS was achieved in 47.8 % of patients . In univariate analysis , the only clinical outcome statistically and negatively related to response was PGA at baseline ( p = 0.047 ) . Radiologically , response to VS was negatively correlated with joint space narrowing ( JSN ) score ( JSN < 2 vs. JSN ≥ 2 , p = 0.01 ) and was related to the patterns of femoral head migration ( p = 0.008 ) . In multivariate analysis , only JSN grade ( p = 0.03 ) remained significantly related to a poor response . Conclusion This pilot study , which needs further confirmation by larger scale trials , suggests that radiological features might be of importance for the decision of VS in patients with HOA.Trial registration numberID RCB N ° 2013-A00165 - 40 . Registered 31 January 2013 OBJECTIVE Several studies on knee osteoarthritis suggest that the intra-articular administration of hyaluronic acid products may be a relevant option in the management of patients with persistent pain . The aim of this study is to report the data of efficacy of US-guided HyalOne ® /Hyalubrix ® 60 injections in a large population of patients with hip osteoarthritis , repeated at least 2 times per year for up to seven years . PATIENTS AND METHODS This is a prospect i ve , post-marketing , cohort study . Data were collected from the ANTIAGE registry . Values of Lequesne index , pain VAS , NSAIDs intake , global medical and patients assessment s were evaluated every six months from the baseline to the end of the follow-up , seven years later . The inclusion criteria were : age ≥18 years , symptomatic hip osteoarthritis of at least 1-year duration , and up to 84 months of follow-up . All the patients received hyaluronic acid injections at least every six months , using ultrasound guidance to ensure accurate placement . RESULTS 1022 patients were included in the study . The patients were categorized by age classes , gender , and body mass index ( BMI ) . All the groups show a statistically significant reduction at all time points compared to baseline values of Lequesne index , pain VAS , NSAIDs intake , global medical and patients assessment s. There are slight differences in the subgroups of overweighted , obese and over 70 years patients . CONCLUSIONS Our study supports the clinical efficacy and safety of HyalOne ® /Hyalubrix ® 60 in patients affected by osteoarthritis . This is the first study , reporting on a large cohort of patients in different categories with a long follow-up on seven years . The data confirm the proper use of ultrasound-guided viscosupplementation ( VS ) as background therapy in the management of hip osteoarthritis Background : Intra-articular hyaluronic acid ( HA ) injection is used in management of knee , h and and hip osteoarthritis . While HA injection is included in the list of evaluated therapies , its efficacy and optimum dosing still have no consensus . This study was conducted to explore the possibility of using single injection HA to increase patient convenience while maintaining the therapeutic efficacy . Methods : We present a prospect i ve , open label , non-blinded , r and omized controlled trial performed in accordance with guidelines in principles of good clinical practice . Block r and omization was done for patients to receive either single 5 ml GO-ON injection or the conventional three injections of 2.5 ml GO-ON at weekly interval . Baseline Western Ontario McMaster University Osteoarthritis ( WOMAC ) scores were evaluated and recorded . All subjects were re-evaluated at 3 months and the WOMAC score recorded again as primary end points . Data analyses were performed with IBM SPSS Statistics for Windows software ( version 21.0 , IBM Corp , Armonk , New York , USA ) . Results : In the cohort of 127 patients , 33 were males and 94 females . The mean age was 59.1 years ( st and ard deviation ( SD ) = 7.25 ) in single injection arm and 60.1 years ( SD = 7.72 ) in triple injection arm . The two groups were recorded to have no significant difference in age ( p = 0.46 ) and Kellgren – Lawrence radiological grade ( p = 0.694 ) . There was significant increase in the WOMAC scores from the baseline ( pre-injection ) to that recorded 3 months after injection ( p < 0.001 ) in patients of both groups . However , there was no statistically significant difference noticed in this clinical improvement between the two arms ( p = 0.889 ) . Conclusion : The study shows single 5 ml dose regime comparing well with conventional three doses of 2.5 ml of intra-articular GO-ON HA injected at weekly intervals and confirms good efficacy , tolerability and safety of single larger dose of GO-ON knee intra-articular injection OBJECTIVE To obtain prospect i ve data on feasibility and safety of intra-articular injections of hylan G-F20 in patients with symptomatic hip osteoarthritis ( OA ) . METHODS Fifty-seven patients with primary hip OA , Kellgren-Lawrence grade II-III , aged > or = 40 and walking pain 50 - 90 mm on a visual analogue scale ( VAS ) were enrolled in an open-label , multicentre pilot trial . Hylan G-F20 ( 2 ml ) was injected intra-articularly ( IA ) in the hip under fluoroscopy at D0 , and follow-up visits were performed at D7 - 30 - 60 - 90 . The possibility of a second injection at D30 - 60 or 90 was considered if the reported pain level was equivalent to baseline . Adverse events , walking pain ( VAS ) , WOMAC index , patient and physician 's global assessment were recorded at each visit . RESULTS Twenty-five patients 1 injection and 32 received 2 injections . Transient hip pain was reported following 10.1 % of injections , but no patient withdrew from the study because of this . Two mild synovial fluid aseptic effusions occurred after the first injection . No systemic device-related adverse event was reported . Walking pain decreased from 69.3 mm at entry to 39.5 mm at the end point ( p < 0.0001 ) . All other outcome measures decreased significantly . CONCLUSION Viscosupplementation with hylan G-F20 is feasible , easy to perform and well-tolerated in hip OA . A double-blind , controlled study should be performed to confirm data on its efficacy This paper aims to compare the results of single-joint knee vs hip hyaluronic acid ( HA ) injections in patients with osteoarthritis ( OA ) involving both the knee and hip joints . Thirty-eight patients who were diagnosed to have both hip and knee OA were enrolled . Patients were divided into two groups to receive HA injection three times at 1-week intervals either to the hip or knee joints . Pain level during activities and rest was measured by using visual analog scale ( VAS ) . Western Ontario and McMaster University Osteoarthritis Index ( WOMAC 5-point Likert 3.0 ) was also used prior to the injections and 1 month after the 3rd injection . In the knee injection group , the intragroup analysis revealed significant improvements in VAS activity pain , VAS rest pain , and WOMAC pain values following injection when compared with preinjection values , while no significant difference was detected in WOMAC stiffness , WOMAC physical function , and WOMAC total values . In the hip injection group , VAS activity pain , VAS rest pain , WOMAC pain , WOMAC stiffness , WOMAC physical function , and WOMAC total values showed significant improvement after the injection when compared with preinjection values . Although statistically not significant ( p > 0.05 ) , the comparison of the differences ( preinjection – postinjection ) between the groups demonstrated higher values in the hip injection group . We imply that intra-articular single-joint HA injections either to the knee or hip joints in OA patients with involvement of both of these joints are effective with regard to pain and functional status AIM To compare the efficacy of ultrasound-guided intra-articular ( IA ) treatment with platelet-rich plasma ( PRP ) versus viscosupplementation ( hyaluronic acid HA ) in hip osteoarthritis . METHODS : A total of 43 patients affected by monolateral severe hip osteoarthritis ( OA ) were included in the study . Patients were r and omized to receive either intra-articular PRP ( 3 ml ) or HA ( 30 mg/2 ml ; 1,000 - 2,900 kDa ) , 3 injections in total - 1/week . Clinical assessment s for each patient were made at baseline ( T0 ) , 4 ( T1 ) , and 16 weeks ( T2 ) of follow-up . The primary efficacy outcome was pain reduction as measured by VAS and by WOMAC pain subscale . RESULTS Data analysis revealed that , compared to T0 , in the PRP-treated group VAS scores significantly decreased at T1 but not at T2 , thereby indicating an early effect on pain which was not maintained at a longer term follow-up . In the HA group a significant decrease of both VAS and WOMAC values was registered only between T0 and T2 . CONCLUSIONS Intra-articular PRP had an immediate effect on pain that was not maintained at longer term follow-up when , on the contrary , the effects of intra-articular HA were evident INTRODUCTION Young adult hip osteoarthritis ( OA ) is a noteworthy problem , although rarer than the elderly form of the disease , causing limitations in social and working activities and prospect s. Treatment options are scarce and surgical procedures , frequently necessary , imply the major drawback of revising the prostheses periodically , whereas chronic nonsteroidal anti-inflammatory drugs ( NSAID ) consumption may provoke side effects . To explore alternative options to both surgery and long-term NSAID use , especially in the case of young patients , viscosupplementation seems to appear as an appropriate tool to relieve pain , ameliorate the function and delay surgery . AIM OF THE STUDY In this study we tackle the issue of the use of hyaluronic acid ( HA ) injections in young adults with symptom
Output:
| There was inconsistent evidence across studies regarding the effectiveness of HA compared to other intra-articular injections .
The formulation of the administered viscosupplementation did not appear to influence outcomes .
Furthermore , rates of conversion to THA were relatively low when evaluating 1- to 4-year follow-up intervals .
Discussion Non-comparative studies consistently demonstrated that HA can achieve satisfactory pain reduction and functional improvement .
However , there was not enough evidence in the current literature regarding whether HA is superior to placebo or other types of intra-articular injections . |
MS212487 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To develop and vali date the Readiness for Implementation Model ( RIM ) . This model predicts a healthcare organization 's potential for success in implementing an interactive health communication system ( IHCS ) . The model consists of seven weighted factors , with each factor containing five to seven elements . DESIGN Two decision-analytic approaches , self-explicated and conjoint analysis , were used to measure the weights of the RIM with a sample of 410 experts . The RIM model with weights was then vali date d in a prospect i ve study of 25 IHCS implementation cases . MEASUREMENTS Orthogonal main effects design was used to develop 700 conjoint- analysis profiles , which varied on seven factors . Each of the 410 experts rated the importance and desirability of the factors and their levels , as well as a set of 10 different profiles . For the prospect i ve 25-case validation , three time-repeated measures of the RIM scores were collected for comparison with the implementation outcomes . RESULTS Two of the seven factors , ' organizational motivation ' and ' meeting user needs , ' were found to be most important in predicting implementation readiness . No statistically significant difference was found in the predictive validity of the two approaches ( self-explicated and conjoint analysis ) . The RIM was a better predictor for the 1-year implementation outcome than the half-year outcome . LIMITATIONS The expert sample , the order of the survey tasks , the additive model , and basing the RIM cut-off score on experience are possible limitations of the study . CONCLUSION The RIM needs to be empirically evaluated in institutions adopting IHCS and sustaining the system in the long term Abstract Objective : To examine the use of evidence based leaflets on informed choice in maternity services . Design : Non-participant observation of 886 antenatal consultations . 383 in depth interviews with women using maternity services and health professionals providing antenatal care . Setting : Women 's homes ; antenatal and ultrasound clinics in 13 maternity units in Wales . Participants : Childbearing women and health professionals who provide antenatal care . Intervention : Provision of 10 pairs of Informed Choice leaflets for service users and staff and a training session in their use . Main outcome measures : Participants ' views and commonly observed responses during consultations and interviews . Results : Health professionals were positive about the leaflets and their potential to assist women in making informed choices , but competing dem and s within the clinical environment undermined their effective use . Time pressures limited discussion , and choice was often not available in practice . A widespread belief that technological intervention would be viewed positively in the event of litigation reinforced notions of “ right ” and “ wrong ” choices rather than “ informed ” choices . Hierarchical power structures result ed in obstetricians defining the norms of clinical practice and hence which choices were possible . Women 's trust in health professionals ensured their compliance with professionally defined choices , and only rarely were they observed asking questions or making alternative requests . Midwives rarely discussed the contents of the leaflets or distinguished them from other literature related to pregnancy . The visibility and potential of the leaflets as evidence based decision aids was thus greatly reduced . Conclusions : The way in which the leaflets were disseminated affected promotion of informed choice in maternity care . The culture into which the leaflets were introduced supported existing normative patterns of care and this ensured informed compliance rather than informed choice . What is already known on this topic Informed Choice leaflets are widely used in maternity care but little is known about their ability to influence informed choice and decision making High quality information is essential for promoting informed choice but is insufficient by itself What this study adds Time constraints and other pressures on health professionals result ed in a lack of discussion of the content of the leaflets Fear of litigation , power hierarchies , and the technological imperative in maternity care limited the choices available Health professionals promoted normative practice s rather than choice , and as women valued their opinions this led to the promotion of informed compliance rather than informed Objectives To describe the development , validation and inter-rater reliability of an instrument to measure the quality of patient decision support technologies ( decision aids ) . Design Scale development study , involving construct , item and scale development , validation and reliability testing . Setting There has been increasing use of decision support technologies – adjuncts to the discussion s clinicians have with patients about difficult decisions . A global interest in developing these interventions exists among both for-profit and not-for-profit organisations . It is therefore essential to have internationally accepted st and ards to assess the quality of their development , process , content , potential bias and method of field testing and evaluation . Methods Scale development study , involving construct , item and scale development , validation and reliability testing . Participants Twenty-five research er-members of the International Patient Decision Aid St and ards Collaboration worked together to develop the instrument ( IPDASi ) . In the fourth Stage ( reliability study ) , eight raters assessed thirty r and omly selected decision support technologies . Results IPDASi measures quality in 10 dimensions , using 47 items , and provides an overall quality score ( scaled from 0 to 100 ) for each intervention . Overall IPDASi scores ranged from 33 to 82 across the decision support technologies sample d ( n = 30 ) , enabling discrimination . The inter-rater intraclass correlation for the overall quality score was 0.80 . Correlations of dimension scores with the overall score were all positive ( 0.31 to 0.68 ) . Cronbach 's alpha values for the 8 raters ranged from 0.72 to 0.93 . Cronbach 's alphas based on the dimension means ranged from 0.50 to 0.81 , indicating that the dimensions , although well correlated , measure different aspects of decision support technology quality . A short version ( 19 items ) was also developed that had very similar mean scores to IPDASi and high correlation between short score and overall score 0.87 ( CI 0.79 to 0.92 ) . Conclusions This work demonstrates that IPDASi has the ability to assess the quality of decision support technologies . The existing IPDASi provides an assessment of the quality of a DST 's components and will be used as a tool to provide formative advice to DSTs developers and summative assessment s for those who want to compare their tools against an existing benchmark Background Decision aids are evidence based tools that assist patients in making informed values-based choices and supplement the patient-clinician interaction . While there is evidence to show that decision aids improve key indicators of patients ' decision quality , relatively little is known about physicians ' acceptance of decision aids or factors that influence their decision to use them . The purpose of this study was to describe physicians ' perceptions of three decision aids , their expressed intent to use them , and their subsequent use of them . Methods We conducted a cross-sectional survey of r and om sample s of Canadian respirologists , family physicians , and geriatricians . Three decision aids representing a range of health decisions were evaluated . The survey elicited physicians ' opinions on the characteristics of the decision aid and their willingness to use it . Physicians who indicated a strong likelihood of using the decision aid were contacted three months later regarding their actual use of the decision aid . Results Of the 580 eligible physicians , 47 % ( n = 270 ) returned completed question naires . More than 85 % of the respondents felt the decision aid was well developed and that it presented the essential information for decision making in an underst and able , balanced , and unbiased manner . A majority of respondents ( > 80 % ) also felt that the decision aid would guide patients in a logical way , preparing them to participate in decision making and to reach a decision . Fewer physicians ( < 60 % ) felt the decision aid would improve the quality of patient visits or be easily implemented into practice and very few ( 27 % ) felt that the decision aid would save time . Physicians ' intentions to use the decision aid were related to their comfort with offering it to patients , the decision aid topic , and the perceived ease of implementing it into practice . While 54 % of the surveyed physicians indicated they would use the decision aid , less than a third followed through with this intention . Conclusion Despite strong support for the format , content , and quality of patient decision aids , and physicians ' stated intentions to adopt them into clinical practice , most did not use them within three months of completing the survey . There is a wide gap between intention and behaviour . Further research is required to study the determinants of this intention-behaviour gap and to develop interventions aim ed at barriers to physicians ' use of decision aids We evaluated the effect of an intervention on call centre nurses ' knowledge of decision support and skills in coaching callers facing value-sensitive health decisions . Forty-one registered nurses at a health call centre were r and omly assigned to an intervention or control group . The intervention was a coaching protocol , online tutorial , skills building workshop and performance feedback . The main outcome measures were : knowledge test ; blinded quality assessment of coaching skills during simulated calls and call duration . Compared with controls , nurses in the intervention group had better knowledge ( 74 versus 60 % , P = 0.007 ) and decision coaching skills ( 81 versus 44 % , P < 0.001 ) , particularly in assessing decisional needs ( information , values clarity , support , stage and timing of decision ) and addressing support issues . Call duration did not differ ( 18.5 versus 16.7 min , P = 0.73 ) . The coaching protocol was rated as compatible with nurses ' views on decision-making and more advantageous compared with their usual practice s. The intervention improved the quality of nurses ' decision coaching without affecting call duration OBJECTIVE To assess the impact of a decision aid on perceived risk of heart attacks and medication adherence among urban primary care patients with diabetes . METHODS We r and omly allocated 150 patients with diabetes to participate in a usual primary care visit either with or without the Statin Choice tool . Participants completed a question naire at baseline and telephone follow-up at 3 and 6 months . RESULTS Intervention patients were more likely to accurately perceive their underlying risk for a heart attack without taking a statin ( OR : 1.9 , CI : 1.0 - 3.8 ) and with taking a statin ( OR : 1.4 , CI : 0.7 - 2.8 ) ; a decline in risk overestimation among patients receiving the decision aid accounts for this finding . There was no difference in statin adherence at 3 or 6 months . CONCLUSION A decision aid about using statins to reduce coronary risk among patients with diabetes improved risk communication , beliefs , and decisional conflict , but did not improve adherence to statins . PRACTICE IMPLICATION S Decision aid enhanced communication about the risks and benefits of statins improved patient risk perceptions but did not alter adherence among patients with diabetes OBJECTIVE Compliance with antipsychotic medication is a major issue in schizophrenia treatment , and noncompliance with antipsychotic treatment is closely related to relapse and rehospitalization . An enhanced involvement of patients with schizophrenia in treatment decisions ( " shared decision making " ) is expected to improve long-term compliance and reduce rehospitalizations . The aim of the present analysis was to study whether shared decision making ( SDM ) in antipsychotic drug choice would influence long-term outcome . METHOD From February 2003 to January 2004 , psychiatric state hospital in patients with a diagnosis of schizophrenia ( ICD-10 ; N = 107 ) were recruited for the trial using a cluster-r and omized controlled design . An SDM program on antipsychotic drug choice consisting of a decision aid and a planning talk between patient and physician was compared with routine care with respect to long-term compliance and rehospitalizations ( 6-month and 18-month follow-up ) . RESULTS On the whole , we found high rates of noncompliance and rehospitalization . There were no differences between intervention and control groups in the univariate analyses . However , when controlling for confounding factors in a multivariate analysis , there was a positive trend ( p = .08 ) that patients in the SDM intervention had fewer rehospitalizations . Additionally , a higher desire of the patient for autonomy and better knowledge at discharge were associated with higher hospitalization rates . CONCLUSION The intervention studied showed a positive trend but no clear beneficial effect on long-term outcomes . A more thorough implementation of SDM ( e.g. , iterative administration of decision aid ) might yield larger effects . Those patients with higher participation preferences are at higher risk for poor treatment outcomes and therefore require special attention . Strategies to match these patients ' needs might improve compliance and long-term outcomes Background . R and omized controlled trials show that patient decision aids ( DAs ) can promote shared decision making and improve decision quality . Despite this evidence , integration of DAs into routine clinical practice has proceeded slowly . Objective . To identify factors that promote or impede integrating DAs into clinical practice in a large health care delivery system . Design . Mixed- methods case study . Setting and Patients . Group Health , an integrated health plan and care delivery system in Washington state . Intervention . The project was carried out in 6 specialty service lines using 12 video-based DAs for preference-sensitive conditions related to elective surgical procedures . Measurements . Process data , site visits , meeting observations , and in-depth interviews conducted with clinical staff , project staff , and health plan leaders in 2009 and 2010 . Results . The project established systemwide and clinic-specific processes that facilitated the distribution of approximately 10,000 DAs over 2 years . Several factors were identified as important for success in this implementation , including strong support from senior leaders , establishing a system for previsit ordering and providing timely feedback to teams about distribution rates , engaging providers and staff in development of the implementation process , and finding ways to address concerns about conditions that were perceived as life-threatening and /or time sensitive . Limitations . Limitations included lack of data on patient perspectives , an implementation setting with salaried providers , and frontline provider interviews conducted in only selected service lines . Conclusions . With strong leadership , financial support , and a well-defined implementation strategy , 12 video-based DAs in 6 specialty service lines were integrated into routine practice over 2 years . Findings from this demonstration may advance the ability of other organizations to use DAs effectively and promote widespread adoption of shared decision making in routine patient care Decision aids ( DAs ) are tools to support patients make informed health decisions with their practition
Output:
| The results point to significant challenges to the implementation of patient decision support using this model , including indifference on the part of health care professionals .
This indifference stemmed from a reported lack of confidence in the content of decision support interventions and concern about disruption to established workflows , ultimately contributing to organizational inertia regarding their adoption .
Conclusions It seems too early to make firm recommendations about how best to implement patient decision support into routine practice because approaches that use a ‘ referral model ’ consistently report difficulties . |
MS212488 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: BACKGROUND About 20 % of infants fed with breast-milk substitutes suffer from Gastro Esophageal Reflux ( GER ) and 1/3 of them also show Cow 's Milk Allergy ( CMA ) symptoms . METHODS We planned this study to assess by dynamic echography the usefulness of an Extensively Hydrolysed Cow 's Milk Formula ( eHF ) in infants suffering from GER . Ten infants showing GER symptoms and 10 normal babies , all fed with breast-milk substitutes , were enrolled . Clinical symptom scores related to GER were assessed for one week . The Gastric Emptying Time ( GET ) was determined by means of dynamic echography after feeding with cow 's milk-derived formulae and again after a week feeding with eHF in subjects previously showing GER symptoms . RESULTS All infants with a clinical diagnosis for GER showed an abnormally high average GET in comparison to normal subjects ( 205 vs 124 min , p = 0.000 ) . Switching to the eHF led to a significant clinical improvement ( p = 0.0039 ) especially in babies skin-test and RAST positive to cow 's milk , and to a significant decrease toward the normal value of the GET ( 167 min , p < 0.001 ) . CONCLUSIONS The eHF tested improves GER symptoms in infants suffering from this disease . Our experience confirms and supports the use of dynamic echography as a reliable , simple , and non-invasive diagnostic method for infants with an increased GET associated with clinical symptoms of GER ABSTRACT : Casein-predominant infant milk formulas have been speculated to predispose to lactobezoar formation in preterm infants due to delayed gastric emptying . There have been , however , no prospect i ve studies to prove this possi-bility . In a r and omized , double-blinded , prospect i ve study , we tested the hypothesis that preterm infants fed casein-predominant milk formula have slower gastric emptying than infants fed whey-predominant formulas . Twenty pre-term infants within the first 4 d of life were r and omized to receive either the whey-predominant formula Similac Special Care ( whey : casein ratio 60:40 ) or an experimental casein-predominant formula ( whey : casein ratio 18:82 ) . Only the protein composition differed between the two formulas . The infants were fed the assigned study formula until they reached approximately 2200 g body weight when a gastric emptying scan was performed , using the design ated study formula mixed with 25 μCi of technetium-99 sulfur colloid . Gastric emptying was followed continuously for 2 h. Gastric emptying at 30 , 60 , 90 , and 120 min was similar between the two study groups . The time for 50 % gastric emptying was 64.9 ± 12.3 min for the infants fed the whey-predominant formula and 56.5 ± 14.8 min for those fed the casein-predominant formula ( p = 0.75 ) . We conclude that the rate of gastric emptying in preterm infants fed casein-predominant formulas is similar to that in those fed whey-predominant formulas BACKGROUND & AIMS Gastric emptying ( GE ) is influenced by the type of nutrition . The objective of this study was to compare GE in infants fed an intact protein formula ( IPF ) , a partially hydrolysed formula ( PHF ) , and an extensively hydrolysed formula ( EHF ) . METHODS This was a double-blind , r and omized , cross-over study . Following a fasting period of > or = 3 h , 20 healthy newborns were fed IPF , PHF , and EHF containing 50 microl (13)C-octanoic acid ( OA ) . Breath sample s were taken before feeding and every 15 min for 4 h thereafter . (13)C-OA breath test was assessed by isotope-ratio mass spectrometry , and GE half-times ( t(1/2 ) ) were determined . RESULTS Seventeen infants with a mean gestational age of 37 wk ( range 28 - 40 wk ) and birth weight of 2698 g ( range 720 - 3690 g ) completed the study . At study initiation , the mean age was 31 d ( range 6 d-13 wk ) and the mean weight was 3466 g ( range 2100 - 5700 g ) . EHF emptied significantly faster than IPF and PHF ( medians 46 vs. 55 and 53 min , respectively , Wilcoxon , P<0.05 for both ) . There was no significant difference between GE of PHF and IPF ( Wilcoxon , P=0.2 ) . CONCLUSIONS EHF may be better tolerated by infants with GE problems Summary The role of delayed gastric emptying ( GE ) in the pathogenesis of gastroesophageal reflux ( GER ) in infants is controversial at present . GE has been shown to be altered by the composition and osmolality of the feedings . This prospect i ve study was undertaken to assess the changes in the GE and the percentage of time GER was detected by scintigraphy using three different formulas on consecutive days in infants with GER . Twenty-eight infants under 1 year of age diagnosed to have GER by extended intraesophageal pH monitoring ( pH being < 4.0 for > 5 % of the duration of the test ) , underwent scintigraphy on three consecutive days using the same volume per single feeding of a casein-predominant , soy , or a wheyhydrolysate formula in a r and omized order . The formulas were isocaloric . Gastric emptying and percentage of GER into the esophagus were estimated for 60 min following these feedings . Mean GER percent during the study was 20.39 , 17.68 , and 16.34 on casein-predominant , soy , and whey-hydrolysate formulas , respectively , and was not significantly different . Mean values of GE were 39.7 % , 44.6 % , and 48.5 % on casein , soy , and whey formula , respectively . No significant difference in GE was also observed between casein-predominant and soy formula . However , a significant difference was observed ( p < 0.05 ) on GE between casein-predominant and whey-hydrolysate feedings . Our data suggest that formula selection may be important in the treatment of conditions associated with delayed gastric emptying The present study was design ed to determine the effects of milk composition and the influence of gastro-oesophageal reflux ( GOR ) on gastric emptying . Cineoesogastrocintigraphy ( COGS ) was performed in 201 infants between 0 - 1 year of age in order to detect GOR , and provided a means of estimation of the gastric emptying ( GE ) . Ninety infants appeared free from GOR and constituted the control group ; 111 had GOR . There infants were fed human milk or various st and ard formulae . In addition , 20 infants fed a whey-hydrolysate formula were tested . An appropriate volume of milk was marked with sulfur-colloid Tc ( 200 microcuries ) . Measurements of gastric radioactivity were made 30 min and 120 min after ingestion . For the whole population , the infants with GOR had slightly more rapid GE after 30 min ( P less than 0.05 ) , but , for the same type of milk , there was no significant difference between GOR and controls . GE did not differ with age or sex , but differed mainly according to the type of milk . In the control group , gastric residual content ( GRC ) at 120 min was 18 + /- 11 per cent with human milk ( n = 7 ) , 16 + /- 21 per cent with whey-hydrolysate formula ( n = 8) , 25 + /- 17 per cent with acidified formula ( n = 13 ) , 26 + /- 19 per cent with whey-predominant formula ( n = 22 ) , 39 + /- 17 per cent with casein-predominant formulae ( n = 20 ) , 47 + /- 19 per cent with follow-up formulae ( n = 16 ) and 55 + /- 19 per cent with cow 's milk ( n = 12 ) . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND & AIM Dysmotility , nausea and vomiting are common among children with cerebral palsy . This study aim ed to evaluate influence of protein composition on rate of gastric emptying and study the relation between gastric emptying and postpr and ial gastrointestinal symptoms . METHODS 15 children with cerebral palsy , using gastrostomy , received four liquid test meals on separate days in r and om order . The meals contained a st and ard carbohydrate and fat base plus one of four protein modules ( 100 % casein ( A ) , hydrolysed whey ( B ) , amino acids ( C ) and 40 % casein/60 % whey ( D ) ) with a total energy of 1 kcal/ml . The (13)C octanoic acid breath test was applied to assess gastric emptying . RESULTS When comparing half emptying time ( T(1/2 ) ) of the fast emptying meals ( meal B , C and D ) with the slowest emptying meal ( meal A ) , more rapid emptying was demonstrated for meal D ( p < 0.001 ) . For meal D , emptying was significantly faster in children with postpr and ial symptoms than in those without ( p < 0.01 ) . CONCLUSION In children with cerebral palsy using gastrostomy , gastric emptying is influenced by type of protein in the meal . The present results also suggest that there is a relation between rapid gastric emptying and postpr and ial gastrointestinal symptoms . CLINICAL TRIALS.GOV : UUSKBK 28200706 BACKGROUND & AIMS The aim was to study the influence of Nissen fundoplication on rate of gastric emptying and postpr and ial symptoms in relation to protein source in liquid meals in children with cerebral palsy . METHODS Ten children with cerebral palsy and Nissen fundoplication and ten with cerebral palsy without Nissen fundoplication were studied . Patients had gastrostomy and received two meals , double-blinded , in r and om order , on separate days . Meals contained a st and ardised carbohydrate and fat base plus one of two protein modules ( Meal A : 100 % casein ; Meal B : 40 % casein/60 % whey ) . The (13)C octanoic acid breath test was used to assess gastric emptying . Postpr and ial symptoms were recorded . Results are given as median . RESULTS For meal A and B , respectively , time until 50 % of the meal had emptied ( T1/2 ) was 110 in the Nissen fundoplication- and 181 min in the non-Nissen fundoplication group , ( p = 0.35 ) and 50 and 85 min ( p = 0.25 ) . Seven in the Nissen fundoplication group reported postpr and ial symptoms to meal B , none in the non-Nissen fundoplication group ( p < 0.01 ) . CONCLUSIONS Compared with cerebral palsy-children without Nissen fundoplication , those with Nissen fundoplication have postpr and ial symptoms more frequently after receiving a rapid emptying meal . Gastric emptying alone , however , does not seem to explain the symptom occurrence . Clinical Trials.gov : UUSKBK 28200706
Output:
| Conclusions Breast milk has a faster GE than formula milk . |
MS212489 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Purpose We prospect ively compared two types of dressing ( conventional gauze-based versus absorbing hydrofibre ) after primary total hip ( THA ) or knee ( TKA ) arthroplasties . Methods Eighty c and i date s for THA ( n = 40 ) or TKA ( s = 40 ) were r and omized : gauze-based versus hydrofibre absorbing ( Aquacel ® , ConvaTec ) . The two groups were comparable at baseline . Results There was a statistically significant decrease of dressing changes in the hydrofibre group ( p = 0.0006 ) . Two patients from the conventional group presented minor wound complications . Nurses ’ satisfaction was significantly higher in the hydrofibre group considering the adherence ( p = 0.04 ) and flexibility ( p = 0.03 ) . Patients experienced a higher satisfaction with respect to ease of movement ( p = 0.01 ) in the hydrofibre group . The cosmetic appearance of the scars six weeks after surgery was found to be similar between groups . Conclusions Our findings support an overall improved comfort for the patients and the medical staff by using hydrofibre dressings after primary THA and TKA . The reduction of required dressing changes was observed also OBJECTIVE To compare the performance of Hydrofiber and alginate dressings used in the treatment of primary hip arthroplasty wounds . METHOD Patients were r and omised into one of two groups , receiving either a Hydrofiber or an alginate dressing . Outcome measures , assessed by daily observations , included skin damage ( erythema , blisters and skin injuries ) and the dressing 's ability to h and le exu date s. Photos of the dressing and the skin area around wounds were taken . Patients noted skin problems , discomfort at mobilisation and pain at dressing removal . RESULTS In the alginate group , there were fewer blisters in the wound area compared with the Hydrofiber group ( 7 % versus 18 % , p=0.03 ) . During dressing removal , fewer patients in the alginate group reported pain than patients in the Hydrofiber group ( 2.1 % versus 15 % , p=0.01 ) CONCLUSION We recommend the use of both dressings following total hip arthroplasty , although the alginate would be our first choice , as we found fewer blisters when using alginate dressings as opposed to Hydrofiber dressings . CONFLICT OF INTEREST None Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Background Postoperative wound infection is a preventable risk . One potential postoperative complication is blistering , which leads to increased pain , delayed healing , and higher care costs . The incidence of wound blisters has been reported to be between 6 and 24 % . The aim of this study is to assess whether the risks of postoperative blistering and wound infections within the first 6 days postsurgery will be reduced using a special dressing compared to a st and ard one . Methods / Design This is a r and omized clinical trial in a University hospital . Patients presenting for knee or hip arthroplasty or spine procedures will be assessed against study inclusion and exclusion criteria . After giving written informed consent , patients will be r and omized to participate in the 7-day study during hospitalization . One hundred patients will be r and omized per group . The primary outcome measure is blistering incidence from day 0 to day 6 postsurgery . Photo documentation will be evaluated in a blinded manner by the Clinical Evaluation Committee ( CEC ) . Discussion A new dressing will be compared to the st and ard wound dressing regarding the risk of postoperative blistering , wound infection , and patient comfort . This study will assess the potential advantages of a modern wound dressing . Trial registration Clinical Trials.gov identifier NCT01988818 ( Entered 13 November 2011 ) OBJECTIVE To investigate the effect of three postoperative dressings on orthopaedic wound healing . METHOD Three hundred orthopaedic patients were divided into three treatment groups and allocated to management with one of three dressings : Primapore , Tegaderm with pad , and OpSite Post-Op . Staff completed a question naire to evaluate the wound progression . Outcome measures were the presence of infection , blistering and the number of dressing changes required . RESULTS There was a significantly lower incidence of blistering with OpSite Post-Op ( 6 % ) than Tegaderm with pad ( 16 % ) and Primapore ( 24 % ) ( p<0.001 ) . Patients in the OpSite Post-Op group had the lowest exu date levels . CONCLUSION Dressings that employ a clear film and have a high moisture vapour transmission rate have been shown to reduce both the rate of blistering and wound discharge . The additional expense inherent in using such dressings may , in reality , prove cost-effective because of the reduced need for dressings changes and the subsequent earlier discharge of these patients from hospital with an uncomplicated wound BACKGROUND Tape blisters after hip surgery can be a source of postoperative morbidity and can increase patient discomfort . The purpose of this prospect i ve study was to compare two different types of tape to determine whether the type of tape influences the rate of blister formation . METHODS Ninety-nine patients ( 100 hips ) were enrolled in the study . Patients were r and omized into one of two treatment groups : one treated with a nonstretchable silk tape and one treated with a perforated , stretchable cloth tape . After surgery , the assigned tape was applied over the postoperative dressing with care not to produce skin tension . At the first dressing change , the presence or absence of blisters was recorded as were the number , size , location , and type of any blisters . The presence or absence of tape blisters was recorded at the time of each subsequent dressing change . RESULTS A tape blister developed on twenty-five hips in twenty-five patients . The risk of a blister developing was 41 % ( twenty of forty-nine patients ) when the nonstretchable silk tape was used and 10 % ( five of fifty patients ) when the perforated cloth tape was used ( relative risk = 4.08 , 95 % confidence interval = 1.53 to 10.87 , p = 0.005 ) . We found no association between formation of tape blisters and the age or gender of the patient , number of medical comorbidities , smoking history , results of nutritional assessment , or type of surgery . CONCLUSIONS The prevalence of tape blisters was significantly lower when perforated cloth tape was used than it was when nonstretchable silk tape was used Introduction : Wound blisters are formed in the epidermis adjacent to surgicalincisions and are a significant cause of morbidity following hipsurgery . This study was design ed to compare two commonly used primary dressings , namely a nonadherent absorbable ( NAA ) dressing and paraffintulle gras ( PTG ) . Monitoring for the subsequent development of woundblisters in the epidermis adjacent to the surgical incision wasthen undertaken It was recently reported that use of a perforated , stretchable cloth tape instead of silk tape reduced the incidenc of postoperative blisters around the hip from 41 % to 10 % . The present prospect i ve r and omized study was conducted to determine whether use of spica b and age ( vs the cloth tape ) could further reduce or eliminate the incidence of these blisters . Patients were r and omized to 2 treatmen groups : perforated , stretchable cloth tape ( Hypafix ; Smit & Nephew , Memphis , Tenn ) and elastic spica b and age tha was started at the lower thigh and was extended aroun the hip and abdomen . After surgery , cloth tape or spic b and age was applied over the postoperative dressing , with care taken not to produce skin tension . At the first dressing change , presence or absence of blisters was recorded , along with their number , size , location , and type . All subsequent dressing changes were done much as they wer at surgery , using the assigned type of dressing . Presence or absence of blisters was recorded at each subsequent dressing change . Two hundred ninety-four patients ( 300 hips ) were enrolled . Twenty-two ( 7.33 % ) of the 300 hips developed a blister . Risk for developing a blister was 10 % with the cloth tape versus 4.67 % with the elastic spica b and age ( P < .09 ) . Surgery type ( arthroplasty vs open reduction and internal fixation [ ORIF ] , P < .03 ) and surgery duration ( P < .05 ) had more of an effect on postoperative blister formation than dressing type Wound care following lower limb arthroplasty has not been subject to in-depth clinical research , primarily because such wounds usually heal without complication . However , when prosthetic implants are used , serious wound problems can be disastrous ( Whitehouse et al. Infect Control Hosp Epidemiol 2002;23:183 - 9 ; Lindwell OM . Clin Orthop Relat Res 1986;211:91 - 103 ) . We report the results of a prospect i ve , r and omised , controlled trial comparing a hydrofibre ( Aquacel ) and central pad ( Mepore ) dressing in the management of acute wounds following primary total hip or knee arthroplasty left to heal by primary intention . Dressing performance was measured in 61 patients receiving total hip or knee replacements . There was a significant reduction in the requirement for dressing changes before five postoperative days in the hydrofibre group ( 43 % compared with 77 % in the central pad group ) , and there were fewer blisters amongst patients in the hydrofibre group ( 13 % compared with 26 % in the central pad group ) . We conclude that there is a potential role for hydrofibre dressing in the management of arthroplasty wounds PURPOSE Postoperative wound complications , especially surgical site infections , influence the outcome after total knee arthroplasty . The purpose of our study was to compare four different wound dressings . Following research questions were asked : ( 1 ) Which dressing is associated with least wound complications ? ( 2 ) Which dressing application is the cheapest ? ( 3 ) Which dressing is most comfortable for the patient ? METHODS 111 patients undergoing a total knee arthroplasty were r and omized in 4 groups . Each group received a different dressing with its specific wound management protocol : ( 1 ) Zetuvit ® with Cosmopor E ® , ( 2 ) Zetuvit ® with Opsite Post-Op Visible ® , ( 3 ) Aquacel Surgical ® and ( 4 ) Mepilex Border ® . Follow-up evaluations were performed on the fifth postoperative day and included assessment of the wound , status of the wound dressing and the patient 's own judgment . Cumulative costs were calculated . RESULTS Clinical ly Mepilex Border ® , a silicone dressing , scored the best . No wound complications were seen in this group . The mean number of dressing renewals was 1.9 for the st and ard dressing which was significantly higher ( p<.0001 ) compared to the other dressings . Opsite Post-op Visible ® was the cheapest dressing . Mepilex Border ® had the best scores for pain , freedom of movement and general comfort . CONCLUSIONS Mepilex Border ® is the most skin-friendly dressing . The number of dressing renewals is a defining factor to calculate the costs . Mepilex Border ® appeared to be the best dressing to use after a total knee arthroplasty INTRODUCTION Cutiplast ( absorbent perforated dressing with adhesive border ; Smith & Nephew ) is commonly used following orthopaedic operation , but complications of its use have been reported . A prospect i ve , r and omised , controlled study was performed to compare the efficacy of Cutiplast versus an Aquacel ( hydrofibre dressing ; ConvaTec ) covered with Tegaderm ( vapour-permeable dressing ; 3 M ) . PATIENTS AND METHODS Two-hundred patients were r and omised to receive one of the two dressings following elective and non-elective surgery of the hip and the knee . We were able to study 183 patients . The condition of the wound and any complications such as skin blistering or signs of infection was noted as was the frequency of dressing changes . RESULTS The Aquacel and Tegaderm dressing was 5.8 times more likely to result in a wound with no complications as compared to a Cutiplast dressing ( odds ratio , 5.8 ; 95 % CI 2.8 - 12.5 ; P < 0.00001 ) . CONCLUSION Aquacel covered by Tegaderm is a superior dressing to Cutiplast following surgery to the hip and knee We conducted a r and omized controlled trial to compare efficacy of an occlusive antimicrobial barrier dressing and a st and ard surgical dressing in patients who underwent primary total joint arthroplasty . Two hundred sixty-two patients were r and omized to receive either an occlusive dressing or a st and ard dressing . Wounds were closed in identical fashion . Outcomes included wound complications , dressing changes , and patient satisfaction . With use of occlusive dressing ( vs st and ard dressing ) , wound complications ( including skin blistering ) were significantly ( P = 0.15 ) reduced ; there were significantly ( P < .0001 ) fewer dressing changes ; and patient satisfaction was significantly ( P < .0001 ) higher . Use of occlusive dressings can reduce wound complications and promote wound healing after total joint arthroplasty AIM OF THE STUDY It is important to
Output:
| There was no evidence that any dressing significantly reduced surgical-site infection rates compared with any other dressing .
Conclusion The evidence available in the current literature suggests that advanced dressings such as film and Hydrofibre dressings have fewer wound complications and better fluid h and ling capacity .
However , insufficient evidence is available to determine whether the use of these advanced dressings reduce periprosthetic joint infection |
MS212490 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE To assess the effects of weight reduction with 10 mg of sibutramine or placebo on blood pressure during 24 hours ( ambulatory blood pressure monitoring ) , on left ventricular mass , and on antihypertensive therapy in 86 obese and hypertensive patients for 6 months . METHODS The patients underwent echocardiography , ambulatory blood pressure monitoring , and measurement of the levels of hepatic enzymes prior to and after treatment with sibutramine or placebo . RESULTS The group using sibutramine had a greater weight loss than that using placebo ( 6.7 % versus 2.5 % ; p<0.001 ) , an increase in heart rate ( 78.3 + /- 7.3 to 82 + /- 7.9 bpm ; p=0.02 ) , and a reduction in the left ventricular mass/height index ( 105 + /- 29.3 versus 96.6 + /- 28.58 g/m ; p=0.002 ) . Both groups showed similar increases in the levels of alkaline phosphatase and comparable adjustments in antihypertensive therapy ; blood pressure , however , did not change . CONCLUSION The use of sibutramine caused weight loss and a reduction in left ventricular mass in obese and hypertensive patients with no interference with blood pressure or with antihypertensive therapy The Trial of Antihypertensive Interventions and Management was a multicenter r and omized , placebo-controlled trial design ed to assess the effectiveness of various combinations of pharmacologic and dietary interventions in the treatment of mild hypertension ( diastolic blood pressure 90 - 100 mmHg ) . The primary outcome was blood pressure change between baseline and 6 months . The study consisted of a 3 X 3 factorial design wherein participants were r and omly allocated to nine drug-diet treatment groups . Drugs included placebo , diuretic , and beta-blocker . Diets were usual , weight loss , and low sodium/high potassium . The basic strategy was to address clinical questions of interest by comparing mean blood pressure changes of selected drug-diet combinations . This paper describes the study including experimental design , sample size considerations , statistical analysis , organizational structure , and baseline findings BACKGROUND Although it is known that plasma leptin concentrations correlate with the amount of adipose tissue in the body , little information is available on the long-term effects on leptin concentrations of changes in diet and exercise . OBJECTIVE We wanted to examine whether changes in dietary energy sources and exercise-mediated energy expenditure , alone or in combination , affect plasma leptin concentrations . DESIGN In a r and omized , 2 x 2 factorial trial , 186 men with metabolic syndrome were divided into 4 groups : diet , exercise , a combination of diet and exercise , and control . Data on dietary intake , physical fitness , and demographics were collected and plasma leptin concentrations were measured before and after a 1-y intervention period . RESULTS Plasma leptin concentrations , body mass index , and fat mass decreased in association with long-term reductions in food intake as well as increased physical activity . By adjusting for either body mass index or fat mass , we observed a highly significant reduction in plasma leptin concentration after both the diet and the exercise interventions . There was no interaction between the interventions , suggesting a direct and additive effect of changes in diet and physical activity on plasma leptin concentrations . CONCLUSION Long-term changes in lifestyle consisting of decreased intake of dietary fat and increased physical activity reduced plasma leptin concentrations in humans beyond the reduction expected as a result of changes in fat mass Aim : The aim of our study was to comparatively evaluate the efficacy and safety of orlistat and sibutramine treatment in obese hypertensive patients , with a specific attention to cardiovascular effects and to side effects because of this treatment BACKGROUND In animal models , cannabinoid-1 receptor ( CB1 ) blockade produces a lean phenotype , with resistance to diet-induced obesity and associated dyslipidaemia . We assessed the effect of rimonabant , a selective CB1 blocker , on bodyweight and cardiovascular risk factors in overweight or obese patients . METHODS patients with body-mass index 30 kg/m2 or greater , or body-mass index greater than 27 kg/m2 with treated or untreated dyslipidaemia , hypertension , or both , were r and omised to receive double-blind treatment with placebo , 5 mg rimonabant , or 20 mg rimonabant once daily in addition to a mild hypocaloric diet ( 600 kcal/day deficit ) . The primary efficacy endpoint was weight change from baseline after 1 year of treatment in the intention-to-treat population . FINDINGS Weight loss at 1 year was significantly greater in patients treated with rimonabant 5 mg ( mean -3.4 kg [ SD 5.7 ] ; p=0.002 vs placebo ) and 20 mg ( -6.6 kg [ 7.2 ] ; p<0.001 vs placebo ) compared with placebo ( -1.8 kg [ 6.4 ] ) . Significantly more patients treated with rimonabant 20 mg than placebo achieved weight loss of 5 % or greater ( p<0.001 ) and 10 % or greater ( p<0.001 ) . Rimonabant 20 mg produced significantly greater improvements than placebo in waist circumference , HDL-cholesterol , triglycerides , and insulin resistance , and prevalence of the metabolic syndrome . The effects of rimonabant 5 mg were of less clinical significance . Rimonabant was generally well tolerated with mild and transient side effects . INTERPRETATION CB1 blockade with rimonabant 20 mg , combined with a hypocaloric diet over 1 year , promoted significant decrease of bodyweight and waist circumference , and improvement in cardiovascular risk factors A group of previously untreated obese hypertensive patients were started on a weight reduction programme supervised by two dietitians working in a general practice surgery . It was stressed from the beginning of the programme that reducing blood pressure was the purpose of the diet . The results of follow-up after six months are presented together with results for a control group of obese hypertensive patients not receiving dietary advice or drug therapy , but being followed by the general practitioner . The weight , systolic blood pressure and diastolic blood pressure of the dieting hypertensive group were significantly lower than those of the non-dieting group after six months . However , the drop-out rate was significantly higher for the dieting group than for the non-dieting group . The results of a separate comparison between a control group of obese normotensive patients following the same dietary programme and the group of dieting obese hypertensive patients are also presented . Attendance rates and weight loss achieved were significantly better for the hypertensive group than for the normotensive group after 12 months . Weight reduction appears to be an effective first-line therapy for approximately 50 % of obese patients with mild to moderate hypertension , and raised blood pressure appears to provide motivation for such patients to attend a dietitian 's clinic and to lose weight BACKGROUND Few trials have evaluated the effects of reduced sodium intake in older individuals , and no trial has examined the effects in relevant subgroups such as African Americans . PATIENTS AND METHODS The effects of sodium reduction on blood pressure ( BP ) and hypertension control were evaluated in 681 patients with hypertension , aged 60 to 80 years , r and omly assigned to a reduced sodium intervention or control group . Participants ( 47 % women , 23 % African Americans ) had systolic BP less than 145 mm Hg and diastolic BP less than 85 mm Hg while taking 1 antihypertensive medication . Three months after the start of intervention , medication was withdrawn . The primary end point was occurrence of an average systolic BP of 150 mm Hg or more , an average diastolic BP of 90 mm Hg or more , the resumption of medication , or a cardiovascular event during follow-up ( mean , 27.8 months ) . RESULTS Compared with control , mean urinary sodium excretion was 40 mmol/d less in the reduced sodium intervention group ( P<.001 ) ; significant reductions in sodium excretion occurred in subgroups defined by sex , race , age , and obesity . Prior to medication withdrawal , mean reductions in systolic and diastolic BPs from the reduced sodium intervention , net of control , were 4.3 mm Hg ( P<.001 ) and 2.0 mm Hg ( P = .001 ) . During follow-up , an end point occurred in 59 % of reduced sodium and 73 % of control group participants ( relative hazard ratio = 0.68 , P<.001 ) . In African Americans , the corresponding relative hazard ratio was 0.56 ( P = .005 ) ; results were similar in other subgroups . In dose-response analyses , end points were progressively less frequent with greater sodium reduction ( P for trend = .002 ) . CONCLUSION A reduced sodium intake is a broadly effective , nonpharmacologic therapy that can lower BP and control hypertension in older individuals This 6-month r and omized study evaluated the safety and efficacy of sibutramine in 57 overweight Hispanic patients with hypertension . Following a 2-week washout to confirm the diagnosis of hypertension , antihypertensive medication was adjusted to achieve a blood pressure less than 140/90 mm Hg before institution of either sibutramine 10 mg or placebo once a day . A body mass index in excess of 27 kg/m2 was required for entry . At study end , weight had changed from 75.4±9.6 to 70.0±9.5 kg in the sibutramine group and from 77.9±9.0 to 74.5±9.4 kg in the placebo group . In the sibutramine group , systolic blood pressure was 127.8±5.8 mm Hg after stabilization and 125.2±8.5 mm Hg after completion of the trial ; respective values for diastolic blood pressure were 82.4±3.7 and 81.5±4.6 mm Hg . With placebo , blood pressure dropped from 129.0±7.1/80.9±4.9 mm Hg to 122.8±9.7/80.3±5.4 mm Hg at the same timepoints . In the sibutramine group , 14 patients reported 21 adverse events , most frequently headache ( n=5 ) , constipation ( n=4 ) , and dry mouth ( n=4 ) . In the placebo group , 13 patients had 20 adverse events . Sibutramine is safe and effective in overweight Hispanic patients with hypertension , but monitoring of blood pressure and titration of antihypertensive medication are necessary OBJECTIVE Plasma renin activity was measured at baseline and 6 months in a trial of nonpharmacologic therapy of mild hypertension to determine whether plasma renin activity predicts the diastolic blood pressure ( DBP ) response to nonpharmacologic therapy . DESIGN , SETTING , AND PARTICIPANTS R and omized controlled trial of volunteers from the general community with mild hypertension ( DBP between 90 and 100 mm Hg ) , off all antihypertensive therapy at baseline , treated in special research clinics ( n = 593 ) . INTERVENTIONS Subjects were r and omly assigned to usual , weight loss , or low sodium/high potassium diet and then r and omly assigned to receive placebo , chlorthalidone , or atenolol . MAIN OUTCOME MEASURES Renin was analyzed as plasma renin activity and as a renin index ( logarithm of 24-hour urinary sodium excretion times logarithm of plasma renin activity ) ( 593 patients at baseline and 6 months ) to correct for varied sodium intakes . The DBP was measured using the r and om zero device . RESULTS Change in DBP at 6 months could be predicted from baseline plasma renin activity or renin index . The DBP was decreased after 6 months of therapy by 2 mm Hg for each unit increase in baseline plasma renin activity and by 0.16 mm Hg for each unit increase in baseline renin index . Patients in the highest renin index quartile had a greater DBP response to atenolol therapy , and patients in the lowest renin index quartile had a greater DBP response to chlorthalidone therapy . Weight loss diet achieved a greater reduction in DBP in patients with higher baseline renin index and had an additive effect on DBP response in both of the drug groups . Patients on a weight loss diet receiving placebo in the highest baseline renin index quartile had a reduction in DBP of 12.4 mm Hg , compared with 4.4 mm Hg in the lowest baseline renin index quartile ( P = .009 ) . A low sodium/high potassium diet had a lesser effect than a weight loss diet on pharmacologic therapy . As with the weight loss diet , patients on a low sodium/high potassium diet in the highest baseline renin index quartile had a greater reduction in DBP than patients in the lowest baseline renin index quartile . CONCLUSIONS These data suggest a significant relationship between baseline levels of plasma renin index and the likelihood of success of nonpharmacologic treatment of hypertension OBJECTIVES To examine the effect of diet and exercise-induced weight loss on bone mineral density in overweight postmenopausal women DESIGN A 1-year prospect i ve , r and omized clinical trial . SETTING Two university medical school research centers . PARTICIPANTS Sixty-seven overweight postmenopausal women , a subset of the women who participated
Output:
| In patients with essential hypertension , therapy with a weight loss diet or orlistat result ed in reductions in body weight and BP .
Although sibutramine treatment reduced body weight , it did not lower BP |
MS212491 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: 1 . The degree to which disruption by mastication affects the glycaemic response to four different carbohydrate foods was investigated in healthy human volunteers ; each food was eaten by six subjects . 2 . Subjects ate meals of sweetcorn , white rice , diced apple or potato on two occasions ; on one occasion they chewed the food thoroughly , on the other occasion they swallowed each mouthful without chewing it . 3 . When the foods were chewed the postpr and ial blood glucose levels rose to levels which varied according to the food ingested . 4 . Swallowing without chewing reduced the glycaemic response to each food , achieving a similar effect as administration of viscous polysaccharides or ' slow-release ' carbohydrates The determine the effect of different foods on the blood glucose , 62 commonly eaten foods and sugars were fed individually to groups of 5 to 10 healthy fasting volunteers . Blood glucose levels were measured over 2 h , and expressed as a percentage of the area under the glucose response curve when the same amount of carbohydrate was taken as glucose . The largest rises were seen with vegetables ( 70 + /- 5 % ) , followed by breakfast cereals ( 65 + /- 5 % ) , cereals and biscuits ( 60 + /- 3 % ) , fruit ( 50 + /- 5 % ) , dairy products ( 35 + /- 1 % ) , and dried legumes ( 31 + /- 3 % ) . A significant negative relationship was seen between fat ( p less than 0.01 ) and protein ( p less than 0.001 ) and postpr and ial glucose rise but not with fiber or sugar content The glycaemic index ( GI ) concept was originally introduced to classify different sources of carbohydrate (CHO)-rich foods , usually having an energy content of > 80 % from CHO , to their effect on post-meal glycaemia . It was assumed to apply to foods that primarily deliver available CHO , causing hyperglycaemia . Low-GI foods were classified as being digested and absorbed slowly and high-GI foods as being rapidly digested and absorbed , result ing in different glycaemic responses . Low-GI foods were found to induce benefits on certain risk factors for CVD and diabetes . Accordingly it has been proposed that GI classification of foods and drinks could be useful to help consumers make ' healthy food choices ' within specific food groups . Classification of foods according to their impact on blood glucose responses requires a st and ardised way of measuring such responses . The present review discusses the most relevant method ological considerations and highlights specific recommendations regarding number of subjects , sex , subject status , inclusion and exclusion criteria , pre-test conditions , CHO test dose , blood sampling procedures , sampling times , test r and omisation and calculation of glycaemic response area under the curve . All together , these technical recommendations will help to implement or reinforce measurement of GI in laboratories and help to ensure quality of results . Since there is current international interest in alternative ways of expressing glycaemic responses to foods , some of these methods are discussed The glycemic response ( GR ) to food is influenced by both intrinsic and extrinsic factors . A consistent observation in GR studies is the wide within- and between-individual variations . The authors hypothesize that between-individual variations in the GR , insulin response ( IR ) and gastric emptying occur even when food particle size is st and ardized . Volunteers were tested on 2 nonconsecutive days after an overnight fast in r and omized order . On 1 day , the volunteers consumed large ( > 2000 μm ) rice particles , and on the second day , small rice particles ( 500 - 1000 μm ) . Subsequently , gastric emptying using the sodium [ (13)C ] acetate breath test ( for 240 minutes ) and GR and IR ( for 120 minutes ) from finger-prick blood sample s were measured . The incremental area under the curve ( IAUC ) for the GR for small particles varied 45 % more compared with whole rice . The small particles elicited a significantly greater GR IAUC than the large particles . The st and ard deviations associated with the IR IAUC for the small particles was 140 % greater than that of the large particles . The total IAUC for IR was also significantly greater for the small particles than the large particles . The between-individual variations associated with gastric emptying times were similar for both sample s. The gastric emptying latency phase , lag , and half time were significantly shorter for the small particles . Ingesting small particles causes faster gastric emptying and produces greater glycemic and IRs . Between-individual variations in GR and IR can be observed even when all the food associated factors including ingested particle size ( mastication ) are controlled for in humans To determine the influence of masticatory efficiency on postpr and ial satiety and glycaemic response , twenty-one healthy males were recruited for this r and omised cross-over trial . The participants consumed a fixed amount of pizza provided in equal-sized portions by chewing each portion either fifteen or forty times before swallowing . Subjective appetite was measured by appetite question naires at regular intervals for 3 h after the meal and plasma sample s were collected for the measurement of selected satiety-related hormones , glucose , insulin and glucose-dependent insulinotropic peptide ( GIP ) concentrations . An ad libitum meal was provided shortly after the last blood sample was drawn and the amount eaten recorded . Compared with fifteen chews , chewing forty times per portion result ed in lower hunger ( P= 0·009 ) , preoccupation with food ( P= 0·005 ) and desire to eat ( P= 0·002 ) . Meanwhile , plasma concentrations of glucose ( P= 0·024 ) , insulin ( P < 0·001 ) and GIP ( P < 0·001 ) were higher following the forty-chews meal . Chewing forty times before swallowing also result ed in a higher plasma cholecystokinin concentration ( P= 0·045 ) and a trend towards a lower ghrelin concentration ( P= 0·051 ) . However , food intake at the subsequent test meal did not differ ( P= 0·851 ) . The results suggest that a higher number of masticatory cycles before swallowing may provide beneficial effects on satiety and facilitate glucose absorption Objective : To determine and compare the glycaemic index ( GI ) values of a range of Vietnamese foods in two racial groups . Design and subjects : Twelve healthy subjects ( six Asian and six Caucasian ) consumed 50 g carbohydrate portions of a reference food ( glucose sugar ) and nine Vietnamese foods ( three rices , three noodle products and three sweet foods ) in r and om order after an overnight fast . The reference food was tested on two separate occasions , and the Vietnamese foods were each tested once . Capillary blood sample s were taken at time 0 ( fasting ) , 15 , 30 , 45 , 60 , 90 and 120 min from the start of each meal . Sample s were analysed for plasma glucose and the incremental areas under the plasma glucose curves ( AUC ) were used to calculate the GI values of the test foods , using glucose as the reference food ( ie GI value of glucose=100 ) . The mean GI value of each food was calculated for the entire group of subjects ( n=12 ) and for both racial groups ( n=6 ) . Results : The three rices had surprisingly high GI values ( 86–109 ) , whereas the noodle products had relatively low GI values ( 39–61 ) . The sugar-rich foods produced intermediate GI values ( 54–79 ) . The GI values for the nine foods calculated separately for the two racial groups were not significantly different from each other ( P=0.26 ) . Conclusions : The GI values derived from Caucasian subjects are likely to be applicable to Asian population s. Varieties of imported rice from Thail and were found to have high GI values . Alternative low-GI staples , such as rice noodles , may be preferable for Asian/Vietnamese people with diabetes . Sponsorship : This study was funded by the University of Sydney . European Journal of Clinical Nutrition ( 2001 ) 55 , Background Glycemic index ( GI ) is intended to be a property of food but some reports are suggestive that GI is influenced by participant characteristics when glucose is used as a reference . Objective To examine the influence of different reference foods on observed GI . Design The GIs of five varieties of rice and a sugary beverage ( LoGiCane ™ ) were tested in 31 European and 32 Chinese participants using glucose or jasmine rice as reference foods . The GIs of two ready-to-eat breakfast cereals ( Kellogg ’s cornflakes and Sustain ) were tested in 20 younger and 60 older people using glucose or Sustain as reference foods . Results The GIs of rice tended to be higher in the Chinese compared with the Europeans when glucose was used as a reference ( jasmine 80 vs 68 , P = 0.033 ; basmati 67 vs 57 , P = 0.170 ; brown 78 vs 65 , P = 0.054 ; Doongara 67 vs 55 , P = 0.045 ; parboiled 72 vs 57 , P = 0.011 ) . There were no between-group differences in GI when jasmine rice was the reference . The GIs of breakfast cereals tended to be lower in younger compared with older groups ( cornflakes 64 vs 81 , P = 0.008 ; Sustain 56 vs 66 , P = 0.054 ) . There was no between-group difference in the GI of cornflakes when Sustain was the reference ( cornflakes 115 vs 120 , P = 0.64 ) . There was no ethnic difference in GI when glucose was the reference for another sugary food ( LoGiCane ™ 60 vs 62 ; P = 0.69 ) . Conclusions A starchy reference may be more appropriate than a glucose beverage when attempting to derive universally applicable GI values of starchy foods . Trial registration The Chinese/European trial is registered with the Australian New Zeal and Clinical Trials Registry as ACTRN12612000519853 Coffee and tea may influence glycaemic responses but it is not clear whether they affect the glycaemic index ( GI ) value of foods . Therefore , to see if coffee and tea affected the mean and SEM of GI values , the GI of fruit leather ( FL ) and cheese puffs ( CP ) were determined twice in ten subjects using the FAO/WHO protocol with white bread as the reference food . In one series subjects chose to drink 250 ml of either coffee or tea with all test meals , while in the other series they drank 250 ml water . The tests for both series were conducted as a single experiment with the order of all tests being r and omised . Coffee and tea increased the overall mean peak blood glucose increment compared with water by 0.25 ( SEM 0.09 ) mmol/l ( P=0.02 ) , but did not significantly affect the incremental area under the glucose response curve . Mean GI values were not affected by coffee or tea but the SEM was reduced by about 30 % ( FL : 31 ( SEM 4 ) v. 35 ( SEM 7 ) and CP : 76 ( SEM 6 ) v. 75 ( SEM 8) for coffee or tea v. water , respectively ) . The error mean square term from the ANOVA of the GI values was significantly smaller for coffee or tea v. water ( F(18 , 18 ) = 2.31 ; P=0.04 ) . We conclude that drinking coffee or tea with test meals does not affect the mean GI value obtained , but may reduce variability and , hence , improve precision We studied 12 subjects with diabetes to determine how well the glycemic index ( Gl ) predicted the ranking of glycemic responses of different foods in individuals . All subjects ate three mixed meals ( bread , rice , or spaghetti with GIs of 100 , 79 , and 61 , respectively ) four times in a r and omized complete block design . The mean glycemic response areas of the different meals ranked according to the predicted Gl in every individual . The observed mean ± SD Gl values of the meals were significantly different from each other ( bread 100 ± 7 , rice 75 ± 9 , spaghetti 54 ± 9 ) , with no significant difference in response between subjects . It is concluded that individuals share common mean Gl values for different foods . Within confidence limits determined by the variability of glycemic responses , the number of repeated tests conducted , and the expected Gl difference , the Gl can be used to predict the ranking of the mean glycemic responses of mixed meals taken by individuals Consumption of a low glycemic index ( GI ) diet may be helpful in the management and prevention of diabetes and cardiovascular disease . The investigation of GI has been predominantly confined to white subjects . We hypothesized that differences in glycemic response ( GR ) may be observable in subjects of different ethnic origin . The objective of the present study was to determine GR to a high GI ( glucose ) and low GI ( maltitol ) test drink in subjects of different ethnic origin . In a r and omized , single-blind crossover trial , 10 whites , 10 South Indians and 10 Chinese subjects consumed either glucose or maltitol test drink containing 50 g of one of the test products on different occasions . Capillary blood glucose sample s were taken at 15 and 10 minutes before and 0 , 15 , 30 , 45 , 60 , 90 , 120 , 150 , and 180 minutes after consumption of the test
Output:
| Conclusions : With the possible exception of rice , existing evidence suggests that GI values do not differ when measured in Caucasians versus non-Caucasians . |
MS212492 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objectives . To compare language development in infants and young children with human immunodeficiency virus ( HIV ) infection to language development in children who had been exposed to HIV but were uninfected , and ( among subjects with HIV infection ) to compare language development with cognitive and neurologic status . Design . Prospect i ve evaluation of language development in infected and in exposed but uninfected infants and young children . Setting . Pediatric Infectious Disease Clinic , State University of New York – Health Science Center at Syracuse . Subjects . Nine infants and young children infected with HIV and 69 seropositive but uninfected infants and children , age 6 weeks to 45 months . Results . Mean Early Language Milestone Scale , 2nd edition ( ELM-2 ) Global Language scores were significantly lower for subjects with HIV infection , compared with uninfected subjects ( 89.3 vs 96.2 , Mann – Whitney U test ) . The proportion of subjects scoring > 2 SD below the mean on the ELM-2 on at least one occasion also was significantly greater for subjects with HIV infection , compared with uninfected subjects ( 4 of 9 infected subjects , but only 5 of 69 uninfected subjects ; Fisher 's exact test ) . Seven of the 9 subjects with HIV infection manifested deterioration of language function . Four manifested unremitting deterioration ; only 1 of these 4 demonstrated unequivocal abnormality on neurologic examination . Three subjects with HIV infection and language deterioration showed improvement in language almost immediately after the initiation of antiretroviral drug treatment . Magnetic resonance imaging or computed tomography of the brain were performed in 6 of 7 infected subjects with language deterioration , and findings were normal in all 6 . ELM-2 Global Language scaled scores showed good agreement with the Bayley Mental Developmental Index or the McCarthy Global Cognitive Index ( r = 0.70 ) . Language deterioration , or improvement in language after initiation of drug therapy , coincided with or preceded changes in global cognitive function , at times by intervals of up to 12 months . Conclusions . Language deterioration occurs commonly in infants and young children with HIV infection , is seen frequently in the absence of abnormalities on neurologic examination or central nervous system imaging , and may precede evidence of deterioration in global cognitive ability . Periodic assessment of language development should be added to the developmental monitoring of infants and young children with HIV infection as a means of monitoring disease progression and the efficacy of drug treatment BACKGROUND The neurodevelopmental outcomes of human immunodeficiency virus type 1 (HIV-1)-infected Ug and an infants of nondrug-using mothers were studied using controlled , prospect i ve methodology . METHOD The sample of 436 full-term infants included 79 HIV-infected infants of HIV-1-infected mothers , 241 uninfected infants of HIV-1-infected mothers ( seroreverters ) , and 116 uninfected infants born to HIV-negative mothers . Neurologic status , information processing ability , and motor and mental development were assessed from 6 to 24 months of age . Observations of caretaker-child interaction and home environments were made at 6 and 12 months . All evaluators were blinded to the HIV status of the child and family . RESULTS Compared with seroreverters and uninfected infants , HIV-infected infants demonstrated greater deficits in motor development and neurologic status , and more frequent and earlier onset of motor and neurologic abnormalities . Compared with controls , HIV-infected infants had more abnormalities in mental development at 6 and 18 months and an earlier onset of abnormalities . By 12 months , 30 % of HIV-infected infants demonstrated motor abnormalities and 26 % cognitive abnormalities as compared with 11 % and 6 % among seroreverters and 5 % and 6 % among seronegative infants . HIV-infected infants ( 62 % ) demonstrated a higher probability of developing an abnormal neurologic examination by 12 months , compared with seroreverters ( 17 % ) or seronegative infants ( 15 % ) . Information-processing abilities did not differ as a function of HIV infection . Home environments and infants ' interactions with caretakers were similar across groups . CONCLUSION We conclude that HIV infection results in more frequent and earlier abnormalities in infants ' neurologic status and motor development that are not attributable to other biological and environmental risk factors . More frequent mental developmental abnormalities were evident at several ages . However , information-processing abilities , such as recognition memory , may be spared from HIV-related deficits Objective . To examine the frequency , timing , and factors associated with abnormal cognitive and motor development during the first 30 months of life in infants born to women infected with human immunodeficiency virus type 1 ( HIV-1 ) . Methods . Serial neurodevelopmental assessment was performed with 595 infants born to women infected with HIV-1 in a multicenter , prospect i ve , natural history cohort study . Survival analysis methods were used to evaluate 6 outcome events related to abnormal cognitive and motor growth ( time to confirmed drop of 1 SD , time to first score < 69 , and time to confirmed drop of 2 SD ) in Bayley Scales of Infant Development Mental Developmental Index ( MDI ) and Psychomotor Developmental Index ( PDI ) scores among infected ( n = 114 ) and uninfected ( n = 481 ) infants . Proportional hazards modeling was used to evaluate the effects of HIV infection status , prematurity , prenatal exposure to illicit drugs , maternal educational attainment , and primary language . Results . HIV-1 infection was significantly associated with increased risk for all outcome events related to abnormal mental and motor growth . Differences between infected and uninfected infants were apparent by 4 months of age . Prematurity was associated with increased risk for MDI < 69 and PDI < 69 . Maternal education of < 9 completed years was associated with increased risk for MDI < 69 . Neither prenatal exposure to illicit drugs nor primary language other than English was associated with abnormal development . Conclusion . A significant proportion of infants with HIV-1 infection show early and marked cognitive and motor delays or declines that may be important early indicators of HIV disease progression . These abnormalities are independent of other risk factors for developmental delay BACKGROUND HIV contributes substantially to child mortality , but factors underlying these deaths are inadequately described . With individual data from seven r and omised mother-to-child transmission ( MTCT ) intervention trials , we estimate mortality in African children born to HIV-infected mothers and analyse selected risk factors . METHODS Early HIV infection was defined as a positive HIV-PCR test before 4 weeks of age ; and late infection by a negative PCR test at or after 4 weeks of age , followed by a positive test . Mortality rate was expressed per 1000 child-years . We investigated the effect of maternal health , infant HIV infection , feeding practice s , and age at acquisition of infection on mortality assessed with Cox proportional hazards models , and allowed for r and om effects for trials grouped geographically . FINDINGS 378 ( 11 % ) of 3468 children died . By age 1 year , an estimated 35.2 % infected and 4.9 % uninfected children will have died ; by 2 years of age , 52.5 % and 7.6 % will have died , respectively . Mortality varied by geographical region , and was associated with maternal death ( adjusted odds ratio 2.27 , 95 % CI 1.62 - 3.19 ) , CD4 + cell counts < 200 per microL ( 1.91 , 1.39 - 2.62 ) , and infant HIV infection ( 8.16 , 6.43 - 10.33 ) . Mortality was not associated with either ever breastfeeding and never breastfeeding in either infected or uninfected children . In infected children , mortality was significantly lower for those with late infection than those with early infection ( 0.52 , 0.39 - 0.70 ) . This effect was also seen in analyses of survival from the age at infection ( 0.74 , 0.55 - 0.99 ) . INTERPRETATION These findings highlight the necessity for timely antiretroviral care , for support for HIV-infected women and children in developing countries , and for assessment of prophylactic programmes to prevent MTCT , including child mortality and infection averted BACKGROUND Combination therapy including protease inhibitors has been shown to be effective in treating adults infected with human immunodeficiency virus type 1 ( HIV-1 ) , but there are only limited data regarding the treatment of children and adolescents . METHODS A cohort of 1028 HIV-1-infected children and adolescents , from birth through 20 years of age , who were enrolled in research clinics in the United States before 1996 was followed prospect ively through 1999 . We used proportional-hazards regression models to estimate the effect on mortality of combination therapy including protease inhibitors . RESULTS Seven percent of the subjects were receiving combination therapy including protease inhibitors in 1996 ; by 1999 , 73 percent were receiving such therapy . In univariate analyses , a higher base-line percentage of lymphocytes that were CD4-positive , a higher weight for age , a higher height for age , black race , Hispanic ethnic background , younger age , and perinatally acquired infection were associated with a longer median time to the initiation of this type of therapy ( P<0.001 ) . After adjustment for covariates , the differences among racial and ethnic groups in the time to initiation were not statistically significant . Mortality declined from 5.3 percent in 1996 to 2.1 percent in 1997 , 0.9 percent in 1998 , and 0.7 percent in 1999 ( P for trend < 0.001 ) . There were reductions in mortality in all subgroups defined according to age , sex , percentage of CD4 + lymphocytes , educational level of the parent or guardian , and race or ethnic background . In adjusted analyses , the initiation of combination therapy including protease inhibitors was independently associated with reduced mortality ( hazard ratio for death , 0.33 ; 95 percent confidence interval , 0.19 to 0.58 ; P<0.001 ) . CONCLUSIONS The use of combination therapy including protease inhibitors has markedly reduced mortality among children and adolescents infected with HIV-1 Neurodevelopmental outcomes of human immunodeficiency virus Type 1 (HIV-1)-infected infants of non-drug-using mothers were assessed in a controlled , prospect i ve study from birth to 24 months with 3 groups : 61 infants of HIV-infected mothers , 234 uninfected infants of HIV-infected mothers ( seroreverters ) , and 115 uninfected infants of uninfected mothers . Compared with seroreverters and uninfected infants , HIV-infected infants demonstrated lower mental and motor development on the Bayley Scales and greater deceleration in their rate of motor development . HIV-infected infants with abnormal neurologic exams had lower motor and mental test scores and lower rates of motor Bayley Scales scores than their HIV-infected counterparts with normal neurologic exams . Contrary to prediction , no group differences in mean performance or growth rates were found on visual information processing on the Fagan Test of Infant Intelligence OBJECTIVE . The purpose of this study was to assess the health status and school-age neurodevelopmental progress of antiretroviral treatment (ARVT)–naive , HIV-infected Ug and an children who had been followed as part of cohorts of children born to HIV-infected and -noninfected mothers between 1989 and 1993 . METHODS . Twenty-eight children , aged 6 to 12 years , vertically infected with HIV-1 and never treated with ARVT were evaluated in terms of health status , neurologic , and psychometric testing . A r and omly selected group of 42 seroreverters and 37 HIV-1 negative children who were age- and gender-matched and who had been followed in the same cohorts were evaluated also . The families studied were homogenous in their socioeconomic status . None of the mothers or children had received ARVT or been exposed to illicit drugs . RESULTS . The HIV-infected children showed significantly more evidence of acute malnutrition . They also had more illness , especially parotitis , otitis media , upper respiratory infections , and lymphadenopathy . However , they did not differ significantly in neurologic and cognitive assessment s when compared with age- and gender-matched seroreverter and HIV-negative children . They were in the normal range with respect to neurologic and psychometric development measures . CONCLUSIONS .These children seem to represent a significant subgroup of HIV-infected child survivors for whom the progress of the disease is less aggressive throughout early life . Given the fact that many infants , especially in developing countries , continue to be born without the benefit of perinatal ARVT , there will likely continue to be many older HIV-infected children in the same situation as those described in this follow-up study . They will not have been recognized as being HIV-infected . It is important that such children be identified and offered access to ARVT and other appropriate support services
Output:
| Although HIV has been shown to affect all domains of child functioning , motor development is the most apparent in terms of severity , early onset , and persistence across age groups . |
MS212493 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Summary The present study was partly a clinical pharmacological analysis of the action of imipramine in nocturnal enuresis and partly an attempt to select children who would benefit most from this treatment . 61 fairly severe cases of nocturnal enuresis were studied as out- patients , divided by the criteria primary / secondary enuresis and with/without associated behavioural disturbances . The patients received imipramine , imipramine-N-oxide , emepronium , and a placebo in r and om sequence in a double-blind cross-over trial . There was no difference in effect between placebo and emepronium ; after imipramine the frequency of enuresis fell to 58 % of the figure during placebo treatment , i.e. 31 % of the children became dry ; imipramine-N-oxide reduced the number of wet nights only to 78 % of the number on placebo , 18 % of the children became dry . When the patients were classified into groups imipramine and imipramine-N-oxide were found to have had the greatest effect in cases of presumed psychogenic aetiology , a 65 % reduction of the frequency of wet nights whilst taking the placebo . The most favourable results were in children with combined nocturnal and diurnal enuresis and in those with urinary frequency and imperative urgency . The effect was maintained during treatment for 3 months with the most suitable drug . The dose was 50 mg regardless of the body weight of the patient . There were no serious side effects . It was concluded that the psychopharmacological actions of imipramine and imipramine-N-oxide appear to be important in their effects on enuresis . Imipramine might have been the best drug because success may require the combination of antidepressant and anticholinergic activity . It was not possible to assess in detail its presumed effect on the level of sleep . Thus many children can be treated successfully and the final cure of enuresis may be hastened by breaking a vicious circle of psychological phenomena Purpose : The treatment approach for enuresis is controversial due to the lack of consensus as to the exact causes of nocturnal enuresis . Despite various treatment modalities , pharmacotherapy still appears to be the common choice . The aim of this prospect i ve study was the evaluation of the efficacy of combination therapy ( imipramine and oxybutynin ) in patients with enuresis nocturna . Patients and Methods : This prospect i ve study was done with 77 monosymptomatic nocturnal enuretics between July 1996 and December 1998 . Results : Even though there is no statistically significant difference between combination therapy ( imipramine plus oxybutynin ) and monotherapy , clinical data showed that combination therapy is more effective . Conclusions : We conclude that combination of imipramine with oxybutynin is a safe and new choice in the treatment of nocturnal enuresis Abstract Sixty-two children with nocturnal enuresis ( 43 boys , 19 girls aged 6–15 years ) were treated with either desmopressin ( Adiuretin-SD ) ( n=32 ) or sodium diclofenac ( n=30 ) . Desmopressin was effective in 85 % of children and diclofenac in 33 % . In children with primary nocturnal enuresis , the glomerular filtration rate was normal , whereas diuresis and solute excretion during the night were increased . Compared with healthy children , the nightly excretion of sodium was elevated by 43.7 % and magnesium by 58.4 % . A high correlation was found between the free water reabsorption and solute clearance ( P<0.001 ) in children with nocturnal enuresis . Changes in kidney function in nocturnal enuresis appear to be due to a decrease in the water and ion reabsorption in the thick ascending limb of Henle ’s loop because of a changed regulation of ion transport in this part of the nephron . Administration of desmopressin or a decrease in prostagl and in production after diclofenac administration restores the ion and water transport in the kidney , which results in the disappearance of nocturnal enuresis . The results indicate a role of changes in regulation of ion transport in renal tubules in the pathogenesis of one of the forms of primary nocturnal enuresis A double-blind clinical study of 30 boys , six to ten years of age , with primary nocturnal enuresis was undertaken to assess the role of and rogens in treating enuresis . The oral synthetic and rogen mesterolone was selected because of its minimal potential toxic effects . Twenty boys were treated with mesterolone and 10 received placebo . Fourteen boys ( 70 % ) became dry during treatment ( 20 mg daily for 14 days ) , and 5 ( 25 % ) remained dry for a follow-up period of four months . Increased cystometric bladder capacity and disappearance of uninhibited detrusor contractions were noticed in a significant number of cases after treatment . No side effects were recorded . Mesterolone has probably modulated the autonomic innervation of the vesical musculature with correction of the defective neural mechanism which is believed to be implicated in the pathogenesis of nocturnal enuresis The prostagl and in synthesis inhibitor indomethacin ( used as a suppository ) was compared to placebo in the treatment of primary nocturnal enuresis in a double-blind crossover study . There were 12 girls and 7 boys between 6 and 15 years old . Indomethacin ( 50 to 100 mg . ) was significantly more effective than placebo in the treatment of primary enuresis OBJECTIVES To compare the efficacy of desmopressin and indomethacin and also determine the prostagl and in E2 ( PGE2 ) concentrations in the patient and control groups . METHODS Eighty-five children with primary nocturnal enuresis were followed up for a baseline period of 4 weeks , during which they recorded wet and dry nights . After this period , the patients were divided into three groups that used desmopressin , indomethacin , or placebo for 4 weeks . The dosage of desmopressin ( group A , n = 31 ) was 20 microg/day and the dosage of indomethacin ( group B , n = 29 ) was 100 mg/day . The placebo group ( group C ) consisted of 25 patients . We determined the serum PGE2 and urine PGE2 concentrations before and after treatment in the three groups and in a control group . RESULTS Treatment with desmopressin and indomethacin result ed in significantly more dry nights during the 4 weeks of observation than did placebo ( P < 0.005 ) . The number of dry nights was also significantly different in the desmopressin group than in the indomethacin group ( P < 0.01 ) . In the total patient group , the mean serum and urine PGE2 concentrations were significantly different from the control group 's serum and urine PGE2 concentrations ( P < 0.001 ) . There was a significant decrease in the serum and urine PGE2 concentrations in group A and group B after the treatment period ( P < 0.01 ) . CONCLUSIONS Desmopressin and indomethacin were found to be more effective than placebo . We conclude that prostagl and ins have an important role in the pathophysiology of primary nocturnal enuresis 1 . The prostagl and in synthesis inhibitor diclofenac sodium has been compared with a placebo in the treatment of primary nocturnal enuresis in a double‐blind crossover trial Summary A study of 45 children with enuresis showed that administration of Methedrine result ed in earlier and more complete relief , compared to those on a placebo The effect of imipramine , desmethylimipramine , and methscopolamine on blood pressure ( BP ) and plasma norepinephrine ( NE ) was measured in enuretic boys in a double‐blind , placebo‐controlled study . Measurements were obtained on the thirteenth day of medication ( 75 mg at bedtime ) . The tricyclic drugs induced a rise in diastolic BP as well as an increase in plasma NE but there was no significant relationship between the increments in plasma NE and BP . The plasma concentration of drug correlated with the drug‐induced BP rise . This is the fifth study to demonstrate a hypertensive effect of tricyclic drugs in children in contrast to the systolic hypotension usually seen in adult patients . It is not clear from our data whether children have different cardiovascular compensatory reflexes or whether they experience a greater stimulant effect from the drug SUMMARY A controlled trial of conditioning by alarm and of amphetamine for the treatment of enuresis was planned . The experimental group was to consist of 118 enuretic schoolchildren of 8 years and over , detected in a community survey , but only 37 could be enrolled for the trial ; 57 had remitted spontaneously or improved before appointments could be made , 15 defaulted , and 9 were rejected as unsuitable . The 37 cases were allocated at r and om to the two treatments . Assessment s were made six months later , by which time 4 further cases had been lost to the trial . Among 33 cases remaining , 16 on alarm and 17 on amphetamine , the results for the alarm were significantly better ; this was more so among the 23 cases whose treatment was considered adequate . Amphetamine had no greater effect than the natural remission-rate . The significance of this result to theories of conditioning and of the mechanism of enuresis is discussed . RESUME Un essai de traitement par conditionnement dans Venuresie nocturne Les auteurs projetaient de comparer l'effet du conditionnement par alarme et de l'amphetamine dans le traitement de l'enuresie . A cet effet , 118 ecoliers enuretiques âges de 8 ans et au-dessus ont ete depistes au cours d'une enquete ; ils devaient constituer le groupe experimental mais 37 seulement ont pu etre enroles pour l'essai . 57 se sont dedits spontanement ou ameliores avant qu'on ait pu les convoquer , 15 ont fait defaut et 9 ont ete rejetes comme impropres a l'essai . Parmi ces 33 restant , 16 traites par alarme et 17 par l'amphetamine , les result ats obtenus par Falarme ont ete nettement meilleurs . L'effet de l'amphetamine ne depassait pas le taux de remission naturel . Les auteurs discutent la signification de ces result ats pour la theorie du conditionnement et celle du mecanisme de l'enuresie Efficacy and tolerance of the anticholinergic and calcium antagonistic drug terodiline ( Mictrol ) were investigated in comparison to placebo in 42 children with diurnal enuresis . The study was double-blind with a modified cross-over design with 2 treatment periods of 4 weeks . Terodiline in a daily dose of 25 mg was well tolerated . A statistically significant decrease in the number of wet episodes per day was found with terodiline when compared to placebo . In addition a high patient preference for terodiline was observed . This study shows that terodiline is effective in the treatment of daytime enuresis in children . The low incidence of side-effects also favours the use of terodiline in children A double-blind study of terodiline compared with placebo was performed in 58 children aged 6 to 14 years with urgency or urge incontinence . All had an unstable bladder at cystometry . A bladder regimen was emphasised during the study . Continence was improved according to micturition charting and a pad test in both groups . Terodiline at 25 mg/day , however , gave significantly better results than placebo . In patients with a subnormal bladder capacity ( less than or equal to 150 ml ) , a significant increase in capacity was recorded on cystometry during medication with terodiline but not with placebo . The improved continence seen in the placebo group was probably due to the non-specific bladder training achieved by the child 's increased awareness and adult involvement during treatment . The even better results attained in the terodiline group shows this drug to be a valuable adjunct to a bladder regimen in children with urge incontinence , particularly since no important adverse effects were noted during an 8-week period The efficacy of treatment with imipramine hydrochloride , desipramine hydrochloride , methscopolamine bromide , and placebo was compared in a study with 40 severely enuretic boys . Both tricyclic antidepressants were superior to placebo and methscopolamine , but they did not differ from each other . Psychiatric disturbance , sleep measures , and other clinical parameters did not predict antienuretic response to tricyclics nor was there a psychotropic response . Plasma concentrations of imipramine and desipramine showed a significant correlation with clinical effect . However , true nonresponders were found , and tolerance to the antienuretic drugs developed in some boys reported by several investigators , Eiectroencephaiographic abnormalities were found in a large percent age of enuretic children by Michael and Sectznd.a , l~ and by others . Some investigators have report , , : frequent occurrences of i : ui , minor genito-urinary abnorma lit i , , ’ ... such as inflammation of the tri~~~ and verumontanum , changes in E;z~ , shape of the internal urethral open ing , and valves or stenosis of tl~~= urethra . Others have described high incidence of coronal adho sions , vulvitis or spina bifida ofcuh,% in enuretics.5 , n. 8 , 10,:Z : Z Still nth&dquo ; , , , have noted a relationship l ~ eti,‘c~~.·tz allergy
Output:
| MAIN RESULTS None of the drugs ( phenmetrazine , amphetamine sulphate/ephedrine + atropine , furosemide ( sic ) or chlorprotixine ) were better than placebo during treatment .
The numbers were too small to draw reliable conclusions , and none are used in current practice in the UK .
Alarm treatment was better than drugs in one small trial .
REVIEW ER 'S CONCLUSIONS There was not enough evidence to suggest that the included drugs reduced bedwetting .
There was limited evidence to suggest that imipramine and alarms were better , and in other review s , desmopressin , tricyclics and alarm interventions have tentatively been shown to be effective |
MS212494 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND The mode of administration for tranexamic acid ( TXA ) to significantly reduce the decrease in hemoglobin ( Hb ) , number of transfusions , relevant costs , and side effects in patients undergoing primary unilateral total knee arthroplasty ( TKA ) has not been resolved . METHODS A total of 560 patients undergoing primary unilateral TKA were r and omized into 4 groups : intravenous group ( 140 patients receiving 2 doses of 20 mg/kg intravenous TXA ) , topical group ( 140 patients administered 3.0 g topical TXA ) , oral group ( 140 patients given 2 doses of 20 mg/kg oral TXA ) , and a control group ( 140 patients not given TXA ) . The primary outcomes included postoperative 48-hour Hb loss and drainage volume , number of transfusions , transfusion and TXA costs , and thromboembolic complications . Secondary outcomes were postoperative inpatient time and wound healing 3 weeks after TKA . RESULTS Baseline data among the 4 groups were similar . The 48-hour Hb loss and drainage volume in the intravenous , topical , and oral groups were significantly less ( P < .05 ) than those in the control group , and the latter had significantly more transfusions and transfusion costs than the other 3 groups ( P < .05 ) . The TXA cost was lowest in the oral group compared with that in the topical and intravenous groups ( P < .05 ) . No differences in thromboembolic complications , postoperative inpatient time , or wound healing were observed among the groups . However , wound dehiscence and continuous wound discharge occurred in the topical group . CONCLUSION All the 3 modes of TXA administration significantly reduced postoperative Hb loss , the number of transfusions , and transfusion costs compared with those in the control group . No pulmonary embolism or infection was observed . Oral TXA is recommended because it provided a similar clinical benefit and result ed in the lowest TXA cost compared with the other 2 modes of TXA administration In our department we use an enhanced recovery protocol for joint replacement of the lower limb . This incorporates the use of intravenous tranexamic acid ( IVTA ; 15 mg/kg ) at the induction of anaesthesia . Recently there was a national shortage of IVTA for 18 weeks ; during this period all patients received an oral preparation of tranexamic acid ( OTA ; 25 mg/kg ) . This retrospective study compares the safety ( surgical and medical complications ) and efficacy ( reduction of transfusion requirements ) of OTA and IVTA . During the study period a total of 2698 patients received IVTA and 302 received OTA . After adjusting for a range of patient and surgical factors , the odds ratio ( OR ) of receiving a blood transfusion was significantly higher with IVTA than with OTA ( OR 0.48 ( 95 % confidence interval 0.26 to 0.89 ) , p = 0.019 ) , whereas the safety profile was similar , based on length of stay , rate of readmission , return to theatre , deep infection , stroke , gastrointestinal bleeding , myocardial infa rct ion , pneumonia , deep-vein thrombosis and pulmonary embolism . The financial benefit of OTA is £ 2.04 for a 70 kg patient ; this is amplified when the cost saving associated with significantly fewer blood transfusions is considered . Although the number of patients in the study is modest , this work supports the use of OTA , and we recommend that a r and omised trial be undertaken to compare the different methods of administering tranexamic acid Background Dexamethasone and tranexamic acid are used to decrease post-rhinoplasty periorbital edema and ecchymosis . We compared the impact of each medication separately or in combination in this regard . Methods A prospect i ve , r and omized triple-blinded study was undertaken on 60 patients who underwent primary open rhinoplasty . They were divided into four groups : Group D ( n = 15 ) received 8 mg dexamethasone , group T ( n = 15 ) received 10 mg/kg tranexamic acid , group DT ( n = 15 ) received both 8 mg dexamethasone and 10 mg/kg tranexamic acid , and group P ( n = 15 ) received neither medication and served as the placebo control group . The medications were given intravenously ( IV ) 1 h before and three doses every 8 h postoperatively . Digital photographs were taken on the first , third and seventh postoperative days . One expert examiner blinded to the study evaluated the periorbital edema and ecchymosis on a scale of 0–4 . Periorbital edema and ecchymosis were examined in all groups . Results In group D , group T and group DT , periorbital edema and ecchymosis ratings were significantly lower compared with the control group ( p < 0.01 ) . No statistically significant difference was seen in preventing or decreasing both periorbital edema and ecchymosis among group D , group T and group DT . Conclusion Tranexamic acid and dexamethasone , separately or in combination , had similar effects in reducing periorbital edema and ecchymosis in open rhinoplasty . Combined application did not show a significantly higher beneficial effect in this regard . Level of Evidence IIIThis journal requires that authors assign a level of evidence to each article . For a full description of these Evidence -Based Medicine ratings , please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 Background : One of the major problems in surgery is intraoperative bleeding which reduces visibility in the operative field . An important task for an anesthetist during head and neck surgery is to improve intraoperative visibility . Objectives : The purpose of this study was to compare the amount of bleeding using different doses of oral metoprolol during three common types of nasal operation ; rhinoplasty , septoplasty and functional endoscopic sinus surgery , as this is one of the complications during head and neck surgery . Patients and Methods : In a r and omized , controlled , open clinical trial , 88 patients who were c and i date s for nasal operations were studied . Patients entering the study were divided into four groups and r and omly assigned to receive 50 mg metoprolol a night before the operation , 50 mg metoprolol on the day of operation , 50 mg metoprolol on the night and on the day of operation , or a placebo . Following the patient ’s preparation on the operating table and after intubation , systolic and diastolic blood pressures were measured in a non-invasive oscillometric way , and their pulse rate was recorded simultaneously . All the data were recorded during the surgery as well . Bleeding was measured by the quality scale proposed by Formme and Boezaart . Results : There was a statistical significance between using metoprolol and the amount of intraoperative bleeding . All patients who received metoprolol the night before surgery and on the day of surgery had slight bleeding during the surgery . In addition , there was a statistical significance between patients ’ agitation levels and the time they received metoprolol . Conclusions : Decreases in both systolic blood pressure and heart rate to less than 60 beats per minute reduces intraoperative bleeding . These rates can be achieved by using beta-blocker drugs . In this study , using a double-dose of metoprolol significantly reduced intraoperative bleeding and improved the quality of the operative field . It also reduced patients ’ agitation in the recovery room Background : Perioperative bleeding is a common side effect of rhinoplasty which may impose the blood transfusion to the patients . As a result of risks and cost of blood transfusion , this study is planned to reduce blood loss in these surgeries . Since tranexamic acid ( TXA ) has been reported to reduce bleeding and subsequent possible need for blood transfusion , the purpose of this study was to evaluate the efficacy of oral TXA on blood loss during rhinoplasty . Methods and Material s : In this double-blind , r and omized , placebo-controlled clinical trial , 50 participants underwent rhinoplastic surgery . These participants were divided into 2 groups ; 25 were r and omly assigned to each 1 . The patients in the first group received 1 g ( 2 × 500 mg ) tranexamic acid tablets , and the patients in the second group received placebo 2 hours before starting the surgery . All patients were operated by the same surgical team and the same anesthetic techniques were used during the surgery . Gender , age , BMI , duration of operation , the amount of blood loss , and surgeon 's satisfaction rate were the variables studied . Results : The first group ( TXA group ) consisted of 11 males ( 44 % ) and 14 females ( 56 % ) and the second group consisted of 13 males ( 52 % ) and 12 females ( 48 % ) . There was no statistical difference in the distribution of the variables between the 2 groups , except for the blood loss , duration of operation , and surgeon 's satisfaction . The mean total blood loss was 144.6 ± 60.28 mL in “ group 1 ” and 199.6 ± 73.05 mL in “ group 2 ” ( P < 0.05 ) . Duration of operation in the first group was less than the second group ( 2.60 ± 0.53 hours vs. 2.99 ± 0.59 hours ) ( P = 0.017 ) . The surgeon was more satisfied with the quality of surgical field and visualization in “ group 1 ” ( 3.76 ± 0.72 ) than “ group 2 ” ( 2.16 ± 0.50 ) ( P = 0.001 ) . Conclusion : The preoperative administration of 1 g oral tranexamic acid significantly decreased the blood loss in patients undergoing rhinoplastic surgery without any significant adverse effects . Iranian registry no : I RCT 201312271674N10 ( www.i rct .ir ) Background There is a rich blood flow to the mucosa in the nasal region . In rhinoplasty , surgical procedures are performed in a narrow and confined space . So bleeding during surgery reduces visibility which can complicate the procedure . This study investigated the effects of the patient position on amount of intraoperative bleeding during surgical procedures . Patients and Methods This r and omized controlled trial was conducted on 71 patients who underwent elective rhinoplasty . The patients were operated on in three groups . Group 1 consisted of 23 patients who were operated on in the supine position ; Group 2 included 28 patients who were operated on using a 15 ° angle reverse Trendelenburg position ; Group 3 consisted of 20 patients who were operated on at a 20 ° angle reverse Trendelenburg position . Results There were statistically significant differences between the groups in regard to surgeon satisfaction and the amount of intraoperative bleeding . The amount of intraoperative bleeding in Group 1 was significantly higher than those of Groups 2 and 3 , and surgeon satisfaction was lower . Conclusions Reverse Trendelenburg position reduces intraoperative bleeding in rhinoplasty patients while facilitating the procedure compared to the supine position . Surgery at a 15 ° angle reverse Trendelenburg position provides the optimum working conditions by both significantly reducing intraoperative bleeding and allowing for comfortable conditions for the surgeon . Level of Evidence IThis journal requires that authors assign a level of evidence to each article . For a full description of these Evidence -Based Medicine ratings , please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 Background This r and omized , double-blind study was design ed to assess the effect of perioperative remifentanil with controlled hypotension on intraoperative bleeding , postoperative edema , and ecchymosis . Methods Fifty-two patients undergoing rhinoplasty were divided into 2 groups . The remifentanil group received 1 µg · kg−1 intravenously as a bolus before induction of anesthesia , 0.5 to 1 µg · kg−1 · h−1 by continuous intravenous infusion during the operation . After anesthesia induction with propofol ( 2–3 mg · kg−1 ) and fentanyl ( 1–15 µg · kg−1 ) , muscle relaxation was achieved with rocuronium ( 0.45–0.90 mg · kg−1 ) . Mean arterial pressure was maintained at 50 to 60 mm Hg in controlled hypotensive anesthesia achieved using remifentanil infusion . Perioperative hemodynamics and bleeding ; early postoperative pain and agitation scale ; postoperative first , third , and seventh day edema ; and ecchymosis were evaluated . Edema and ecchymosis were evaluated using grade d scale from 0 to 4 . Results Remifentanil reduced mean arterial pressure during the entire operative period and the first 30 minutes postoperatively ( P < 0.05 for these comparisons ) . Intraoperative bleeding also decreased ( P < 0.001 ) . There was a significant decrease in edema in both upper and lower eyelid edema on the first and third days in the remifentanil group , although this difference was not detected on the seventh day ( P1upper = 0.000 , P1lower = 0.000 , P3upper = 0.008 , and P3lower = 0.002 ) . Ecchymosis decreased significantly in both upper and lower eyelids on the first , third , and seventh days in the remifentanil group ( P1upper = 0.000 , P3upper = 0.000 , P3upper = 0.002 , P3lower =
Output:
| Conclusions and Relevance Current available evidence suggests that preoperative administration of tranexamic acid is safe and may reduce intraoperative bleeding as well as postoperative eyelid edema and ecchymosis in patients undergoing rhinoplasty |
MS212495 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: OBJECTIVE This study was undertaken to compare outcomes after anterior colporrhaphy with and without a solvent dehydrated cadaveric fascia lata graft . STUDY DESIGN A total of 162 women were enrolled in a prospect i ve , r and omized trial that evaluated the impact of a solvent dehydrated cadaveric fascia lata patch on recurrent anterior vaginal prolapse . Subjects were r and omly assigned to st and ard colporrhaphy with or without a patch . Before and after surgery , subjects were evaluated by both the Baden-Walker and pelvic organ prolapse quantification systems . " Failure " was defined as stage II anterior wall prolapse or worse . RESULTS Of 154 women r and omly assigned ( 76 patch : 78 no patch ) , all underwent surgery and 153 ( 99 % ) returned for follow-up . Sixteen women ( 21 % ) in the patch group and 23 ( 29 % ) in the control group experienced recurrent anterior vaginal wall prolapse ( P = .229 ) . Only 26 % of all recurrences were symptomatic . Concomitant transvaginal Cooper 's ligament sling procedures were associated with a dramatic decrease in recurrent prolapse ( odds ratio [ OR ] 0.105 , P < .0001 ) . CONCLUSION Solvent dehydrated fascia lata as a barrier does not decrease recurrent prolapse after anterior colporrhaphy . Transvaginal bladder neck slings were associated with a significant reduction in the risk of recurrent anterior wall prolapse OBJECTIVE : To present the 3-year outcomes of a double-blind , multicenter , r and omized trial comparing vaginal prolapse repair with and without mesh . METHODS : This was a planned final analysis of women with Pelvic Organ Prolapse Quantification ( POP-Q ) stage 2–4 prolapse r and omized to traditional vaginal prolapse surgery without mesh and vaginal colpopexy repair with mesh . We evaluated anatomic , symptomatic , and combined cure rates for those with at least 3-year vali date d quality -of-life question naires and 2- or 3-year postoperative blinded POP-Q examination . Participants undergoing reoperation for recurrent prolapse were removed for anatomic and subjective outcomes analysis and considered failures for combined outcomes analysis . RESULTS : Sixty-five women were enrolled ( 33 mesh , 32 no mesh ) before the study was prematurely halted as a result of a 15.6 % mesh exposure rate . At 3 years , 51 of 65 ( 78 % ) had quality -of-life question naires ( 25 mesh , 26 no mesh ) and 41 ( 63 % ) had examinations . Three participants died , three required reoperation for recurrent prolapse ( all in mesh group ) , and eight were lost to follow-up . No differences were observed between groups at 3 years for prolapse stage or individual prolapse points . Stage improved for each group ( 90 % and 86 % ) from baseline to 3 years ( P<.01 ) . Symptomatic improvement was observed with no differences in scores between groups . Cure rates did not differ between groups using a variety of definitions , and anatomic cure was lowest for the anterior compartment . CONCLUSION : There was no difference in 3-year cure rates when comparing patients undergoing traditional vaginal prolapse surgery without mesh with those undergoing vaginal colpopexy repair with mesh . CLINICAL TRIAL REGISTRATION : Clinical trials.gov , www . clinical trials.gov , NCT00475540 . LEVEL OF EVIDENCE : OBJECTIVE : To compare anatomical and patient-reported outcomes at 12 months postoperatively for women who had anterior compartment pelvic organ prolapse ( POP ) surgery using a repair augmented with porcine small intestine submucosa mesh ( Mesh Group ) compared with those who had a native tissue repair ( No Mesh Group ) . METHODS : This was a r and omized controlled trial with 12 months follow-up . The surgical procedure was identical in both groups except for the placement of intervening mesh . The primary outcome was anatomical “ cure ” ( Ba of −1 or less on Pelvic Organ Prolapse Quantification [ POP-Q ] ) . Secondary outcomes included POP-Q stage , patient-reported outcomes , and patient satisfaction . The study was powered to detect a 40 % difference at 80 % power ( & agr;=0.05 ) . RESULTS : Fifty-seven women were r and omized ( 28 to Mesh Group , 29 to No Mesh Group ) . Forty-five ( 79 % ) underwent concomitant surgery . At the 12-month follow-up , 56 % ( 15/27 ) in the Mesh Group and 61 % ( 17/28 ) in the No Mesh Group were considered cured ( relative risk 0.90 , 95 % confidence interval 0.52–1.54 ) . There were no significant differences between groups in recurrent or persistent prolapse ( 7 % in each group ) nor in patient-reported outcomes at 12 months . Pelvic girdle pain occurred in 4 of 27 in the Mesh Group and 3 of 28 in the No Mesh Group . CONCLUSION : No significant differences were observed in anatomical or patient-reported outcomes outcome parameters at 12 months after correction of symptomatic anterior POP by mesh or no mesh repair . In our study , porcine small intestine submucosa mesh did not confer additional benefit over a native tissue repair . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT0095544 . LEVEL OF EVEDIENCE : Introduction and hypothesisTo compare the efficacy of a collagen-coated polypropylene mesh and anterior colporrhaphy in the treatment of stage 2 or more anterior vaginal wall prolapse . Methods Prospect i ve , r and omized , multicenter study conducted between April 2005 and December 2009 . The principal endpoint was the recurrence rate of stage 2 or more anterior vaginal wall prolapse 12 months after surgery . Secondary endpoints consisted of functional results and mesh-related morbidity . Results One hundred and forty-seven patients were included , r and omized and analyzed : 72 in the anterior colporrhaphy group and 75 in the mesh group . The anatomical success rate was significantly higher in the mesh group ( 89 % ) than in the colporrhaphy group ( 64 % ) ( p = 0.0006 ) . Anatomical and functional recurrence was also less frequent in the mesh group ( 31.3 % vs 52.2 % , p = 0.007 ) . Two patients ( 2.8 % ) were reoperated on in the colporrhaphy group for anterior vaginal wall prolapse recurrence . No significant difference was noted regarding minor complications . An erosion rate of 9.5 % was noted . De novo dyspareunia occurred in 1/14 patients in the colporrhaphy group and in 3/13 patients in the mesh group . An analysis of the quality of life question naires showed an overall improvement in both groups , with no statistical difference between them . Satisfaction rates were high in both groups ( 92 % in the colporrhaphy group and 96 % in the mesh group ) . Conclusion Trans-obturator Ugytex ® mesh used to treat anterior vaginal wall prolapse gives better 1-year anatomical results than traditional anterior colporrhaphy , but with small a increase in morbidity in the mesh group The aim of this study was to evaluate the anatomical and functional results of a low-weight polypropylene mesh coated with an absorbable film in prolapse surgery by vaginal route . We have conducted a prospect i ve multicentre study in 13 gynaecological and urological units . There were 230 patients requiring repair for anterior or posterior vaginal prolapse included . The present report is based on the analysis of the first 143 patients evaluated after at least 10 months follow-up . All patients were operated by the vaginal route using a specially design ed mesh ( Ugytex , Sofradim , France ) . Prolapse severity were evaluated using the Pelvic Organ Prolapse staging system . Symptoms and quality of life were evaluated preoperatively and during follow-up using the vali date d Pelvic Floor Distress Inventory ( PFDI ) and Pelvic Floor Impact Question naire ( PFIQ ) self- question naires . Mean age was 63 years ( 37–91 ) . Anterior , posterior and anterior – posterior repair with the mesh were performed in 67 ( 46.9 % ) , 11 ( 7.7 % ) and 65 ( 45.4 % ) patients , respectively . With a mean follow-up of 13 months ( 10–19 ) , 132 patients were considered anatomically cured ( 92.3 % ) with a recurrence rate of 9 of 132 for cystocele ( 6.8 % ) and 2 of 76 for rectocele ( 2.6 % ) . Nine vaginal erosions occurred ( 6.3 % ) , six of them necessitated another procedure by simple excision . The rate of de novo dyspareunia was 12.8 % . At follow-up , improvement of PFDI and PFIQ scores were highly significant ( p<0.0001 ) . The use of low-weight polypropylene mesh coated with a hydrophilic absorbable film for vaginal repair of genital prolapse seems to decrease local morbidity while maintaining low recurrence rates Introduction and hypothesisThis trial aim ed to compare the outcomes of native vaginal tissue repair versus polypropylene mesh repair for the treatment of severe genital prolapse . Methods This multicenter r and omized trial included 184 women , with POP-Q stage 3 or 4 . They were r and omly assigned to undergo surgical treatment using native tissue repair ( n = 90 ) or synthetic mesh repair ( n = 94 ) . Native tissue repair surgery was performed according to site-specific defects , including sacrospinous ligament fixation for apical defects . Mesh repair ( Prolift ™ ) was performed in accordance with manufacturer recommendations . Hysterectomy was performed in all cases of uterine prolapse . Statistical tests were used to compare between-group and within-group differences before the surgery and at 1-year follow-up . We considered cure to have occurred when the POP-Q point evaluation was equal to or less than 0 and POP-Q point C better than or equal to half the total vaginal length ( TVL ) after 1 year . The patients answered the Prolapse Quality -of-Life Question naire ( PQoL ) and the Sexual Quotient Female Version ( QS-F ) question naire . Results Both groups were homogeneous preoperatively . There were no differences between the groups in operative time , complications or pain . At 1-year follow-up , anatomical cure rates were better in the mesh group in the anterior compartment ( p = 0.019 ) . Significant improvement in PQoL scores at 1-year follow up were observed in each group ; between-group comparisons of changes in PQoL scores revealed greater improvement in the mesh group . Conclusion Both techniques were effective . Anatomical efficacy was superior in the mesh group regarding the anterior compartment ; quality of life changes were also greater in the mesh group . Complications were significantly higher in the mesh group Introduction and hypothesisThe aim of the study was to compare the efficacy and safety of transvaginal trocar-guided polypropylene mesh insertion with traditional colporrhaphy for treatment of anterior vaginal wall prolapse . Methods This is a r and omized controlled trial in which women with advanced anterior vaginal wall prolapse , at least stage II with Ba ≥ + 1 cm according to the Pelvic Organ Prolapse Quantification ( POP-Q ) classification , were r and omly assigned to have either anterior colporrhaphy ( n = 39 ) or repair using trocar-guided transvaginal mesh ( n = 40 ) . The primary outcome was objective cure rate of the anterior compartment ( point Ba ) assessed at the 12-month follow-up visit , with stages 0 and I defined as anatomical success . Secondary outcomes included quantification of other vaginal compartments ( POP-Q points ) , comparison of quality of life by the prolapse quality of life ( P-QOL ) question naire , and complication rate between the groups after 1 year . Study power was fixed as 80 % with 5 % cutoff point ( p < 0.05 ) for statistical significance . Results The groups were similar regarding demographic and clinical preoperative parameters . Anatomical success rates for colporrhaphy and repair with mesh placement groups were 56.4 vs 82.5 % ( 95 % confidence interval 0.068–0.54 ) , respectively , and the difference between the groups was statistically significant ( p = 0.018 ) . Similar total complication rates were observed in both groups , with tape exposure observed in 5 % of the patients . There was a significant improvement in all P-QOL domains as a result of both procedures ( p < 0.001 ) , but they were not distinct between groups ( p > 0.05 ) . Conclusions Trocar-guided transvaginal synthetic mesh for advanced anterior POP repair is associated with a higher anatomical success rate for the anterior compartment compared with traditional colporrhaphy . Quality of life equally improved after both techniques . However , the trial failed to detect differences in P-QOL scores and complication rates between the groups Introduction and hypothesisVaginal mesh kits are increasingly used in the management of pelvic organ prolapse . This study aim ed to determine similarity of outcomes of the Anterior Prolift ® with Perigee ® systems for anterior compartment prolapse . Methods Consecutive women undergoing Perigee ® or Anterior Prolift ® for symptomatic stage 2 or greater anterior vaginal prolapse were prospect ively evaluated . Main outcome measures included objective and subjective success rates , perioperative outcomes , patient satisfaction , and complications . Results One hundred and six women (
Output:
| In the anterior vaginal compartment , synthetic nonabsorbable mesh consistently showed improved anatomic and bulge symptom outcomes compared with native tissue repairs based on meta-analyses .
Other subjective outcomes , including urinary incontinence or dyspareunia , generally did not differ .
Biologic graft or synthetic absorbable mesh use did not provide an advantage in any compartment .
Synthetic mesh use in the posterior or apical compartments did not improve success .
: Synthetic mesh augmentation of anterior wall prolapse repair improves anatomic outcomes and bulge symptoms compared with native tissue repair .
Biologic grafts do not improve prolapse repair outcomes in any compartment .
Mesh erosion occurred in up to 36 % of patients , but reoperation rates were low |
MS212496 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE This study examined the impact of a brief pain communication/education intervention on patient outcomes in breast cancer . We hypothesized that our intervention would improve patient communication and reduce misconceptions ( " Barriers " ) concerning pain management , and that patients with lower Barriers , or who perceived their physician as being more facilitative and receptive , would report better outcomes . METHODS Female breast cancer patients with persistent pain ( n=89 ) were r and omly assigned to either a 30-min in-person pain education/communication intervention or control condition and followed for 12 weeks . RESULTS Intervention group patients reported a significant decrease in pain Barriers but not in other outcomes . Overall , patients with lower barrier scores reported less distress and better emotional well-being . Patients who scored higher in active communication ( e.g. , asking questions , giving information ) reported fewer Barriers and better pain relief . Individuals who perceived their physicians as being more receptive reported better pain management while those who perceived their physicians as being both more receptive and facilitative were more satisfied with their health care . CONCLUSION A brief education/communication intervention reduced patients ' Barriers to pain management but did not impact other patient outcomes . PRACTICAL IMPLICATION S Pain outcomes may be improved by addressing patients ' pain misconceptions and emphasizing a receptive and responsive communication style Background : Pain is 1 of the most common symptoms that a cancer patient would experience . A significant barrier to positive pain management is patients ’ misconceptions regarding analgesics and inadequate use of nonpharmacological strategies as pain relief . Objective : The purpose of this study was to investigate the effectiveness of a pain management program ( PMP ) on pain intensity , use of PRN drugs and nonpharmacological strategies as pain relief , and barriers to managing pain in cancer patients . Methods : The study was conducted in the palliative care and hospice ward of a public hospital in Hong Kong . Patients were r and omized to either an experimental group ( receiving the PMP ) or a control group ( routine care ) . There were 38 hospitalized patients , with 20 ( 13 males and 7 females ) in the experimental group and 18 ( 11 males and 7 females ) in the control group ; mean age was 61.95 years ( experimental group ) to 63.94 years ( control group ) . Results : Upon the completion of PMP , pain scores were significantly reduced in both groups , yet patients in the experimental group showed a significant increase in the use of PRN analgesics and nonpharmacological strategies to relieve pain ( P < .05 ) and significantly reduce barriers to managing their cancer pain ( P < .05 ) compared with the control group . Conclusion : Cancer patients should be empowered with pain management education to gain knowledge and correct misconceptions in managing their cancer pain . Implication s for Practice : Integration of the PMP into routine clinical work may help to improve the st and ard of care for cancer patients . It is recommended to provide pain management education to all cancer patients Introduction The prevalence of pain in patients with cancer is still too high . Factors relating to ineffective pain treatment fall into three categories : the health care system , professional care providers , and patients . In patients , various barriers lead to noncompliance . Previous educational interventions have increased their knowledge of pain and decreased short-term pain levels . In this r and omized controlled trial , the authors investigated how an intensive home-based education program given by nurses affected short-term and long-term pain levels . Material s and methods One hundred and twenty cancer patients were r and omized to receive either the pain education program ( PEP ) or usual care . Pain , knowledge , quality of life , anxiety , and depression were measured at baseline and after 4 and 8 weeks . In the intervention group , effects on symptom levels were communicated to the treating physician . Results The level of pain had decreased at 4 weeks , but not at 8 weeks . Significant decreases in pain only persisted in those patients with a high pain score at baseline . Knowledge of pain significantly increased in the intervention group . No correlation was found between increased pain knowledge and decreased pain levels . Conclusions The PEP given by nurses lowered pain intensity levels in cancer patients and increased their knowledge of pain . More attention should be paid to patient education and to communication between patients and health professionals regarding pain and pain management PURPOSE / OBJECTIVES To test the effectiveness of two interventions compared to usual care in decreasing attitudinal barriers to cancer pain management , decreasing pain intensity , and improving functional status and quality of life ( QOL ) . DESIGN R and omized clinical trial . SETTING Six outpatient oncology clinics ( three Veterans Affairs [ VA ] facilities , one county hospital , and one community-based practice in California , and one VA clinic in New Jersey ) Sample : 318 adults with various types of cancer-related pain . METHODS Patients were r and omly assigned to one of three groups : control , st and ardized education , or coaching . Patients in the education and coaching groups viewed a video and received a pamphlet on managing cancer pain . In addition , patients in the coaching group participated in four telephone sessions with an advanced practice nurse interventionist using motivational interviewing techniques to decrease attitudinal barriers to cancer pain management . Question naires were completed at baseline and six weeks after the final telephone calls . Analysis of covariance was used to evaluate for differences in study outcomes among the three groups . MAIN RESEARCH VARIABLES Pain intensity , pain relief , pain interference , attitudinal barriers , functional status , and QOL . FINDINGS Attitudinal barrier scores did not change over time among groups . Patients r and omized to the coaching group reported significant improvement in their ratings of pain-related interference with function , as well as general health , vitality , and mental health . CONCLUSIONS Although additional evaluation is needed , coaching may be a useful strategy to help patients decrease attitudinal barriers toward cancer pain management and to better manage their cancer pain . IMPLICATION S FOR NURSING By using motivational interviewing techniques , advanced practice oncology nurses can help patients develop an appropriate plan of care to decrease pain and other symptoms BACKGROUND Inadequate adherence to prescribed analgesics may be one of the reasons why patients with cancer experience unrelieved pain . Adherence is directly influenced by patients ' barriers about pain management . Patient pain education programs ( PEPs ) have been developed to reduce patients ' barriers and increase patients ' adherence to their analgesics . The purpose of this article was to evaluate patients ' adherence in patients receiving a pain consult and patient pain education in comparison with patients receiving st and ard pain treatment ( st and ard care [ SC ] ) , to better explore the difficulties in medication adherence in cancer-related pain and the effects of PEP . METHODS In 54 adult out patients with cancer-related pain , patients ' adherence to the prescribed around-the-clock analgesics was measured with a Medication Event Monitoring System , in the following time intervals : weeks 1 and 2 , weeks 3 and 4 , and weeks 7 and 8 after r and omization . Adherence was differentiated into taking adherence , taking the correct dose , and taking analgesics at the right time intervals . RESULTS Taking adherence increased in the intervention group compared to baseline ( from 91 % to 93 % ) and decreased in the SC group ( from 85 % to 78 % ; P < 0.05 ) . At the end of the study , more patients in the intervention group took their analgesics at the right intervals ( 78 % ) than did patients in the SC group ( 64 % , P < 0.05 ) . During the study , patients were more adherent to opioids than to World Health Organization step 1 analgesics . CONCLUSION The combined intervention can increase adherence . The true problem in pain management is that patients do not take their prescribed analgesics at the right time intervals . With the detailed adherence information from this study , it is possible to further tailor patient education to the individual patient ABSTRACT Cancer pain management can be improved by overcoming patients ’ attitudinal barriers to reporting pain and using analgesics . A simple cost‐effective barriers intervention design ed to reach a large number of persons with cancer has not yet been tested . Such an intervention should be tested against barriers ’ assessment ‐alone , as well as no‐treatment control . The purpose of this study was to test the efficacy and the cost effectiveness of a tailored barriers intervention ( TBI ) , an educational intervention tailored to participants ’ attitudinal barriers toward reporting pain and using analgesics . This was a r and omized three‐group ( TBI , assessment ‐alone , or control ) trial with measures at baseline and 28 days later conducted at the North Central and Heartl and offices of the Cancer Information Service ( CIS ) , an NCI program that provides information to persons seeking answers to cancer‐related questions . Participants ( 1256 adult CIS callers diagnosed with cancer with moderate to severe pain in the past week ) joined the study and were r and omized . Of these participants , 970 ( 77.23 % ) provided follow‐up data . The TBI consisted of educational messages tailored to each participant ’s attitudinal barriers , delivered orally over the telephone , followed by a printed mailed copy . The outcome measures were attitudinal barriers to pain management , as well as pain outcomes ( duration , severity , and interference with life activities ) . At follow‐up the TBI group had significantly lower attitudinal barriers scores compared to assessment ‐alone and control , but the groups did not differ on the pain outcome variables . TBI and assessment ‐alone had similar cost effectiveness . The TBI needs to be strengthened to achieve reductions in pain severity & NA ; St and ard guidelines for cancer pain treatment routinely recommend training patients to reduce barriers to pain relief , use medications appropriately , and communicate their pain‐related needs . Methods are needed to reduce professional time required while achieving sustained intervention effectiveness . In a multisite , r and omized controlled trial , this study tested a pain training method versus a nutrition control . At six oncology clinics , physicians ( N = 22 ) and nurses ( N = 23 ) enrolled patients ( N = 93 ) who were over 18 years of age , with cancer diagnoses , pain , and a life expectancy of at least 6 months . Pain training and control interventions were matched for material s and method . Patients watched a video followed by about 20 min of manual‐st and ardized training with an oncology nurse focused on review ing the printed material and adapted to individual concerns of patients . A follow‐up phone call after 72 h addressed individualized treatment content and pain communication . Assessment s at baseline , one , three , and 6 months included barriers , the Brief Pain Inventory , opioid use , and physician and nurse ratings of their patients ’ pain . Trained versus control patients reported reduced barriers to pain relief ( P < .001 ) , lower usual pain ( P = .03 ) , and greater opioid use ( P < .001 ) . No pain training patients reported severe pain ( > 6 on a 0–10 scale ) at 1‐month outcomes ( P = .03 ) . Physician and nurse ratings were closer to patients ’ ratings of pain for trained versus nutrition groups ( P = .04 and < .001 , respectively ) . Training efficacy was not modified by patient characteristics . Using video and print material s , with brief individualized training , effectively improved pain management over time for cancer patients of varying diagnostic and demographic groups The purpose of this r and omized controlled study was to assess the effects of a structured pain education program on the pain experience of hospitalized cancer patients . Eligible cancer pain patients were r and omly assigned to either an experimental group ( receiving pain education 10–15 min per day for 5 days , n=15 ) or a st and ard care control group ( n=15 ) . The effects of the intervention on six pain-related variables were evaluated using three instruments . Pain intensity , pain interference with daily life , negative beliefs about opioids , beliefs about endurance of pain , pain catastrophizing ( an individual ’s tendency to focus on and exaggerate the threat value of painful stimuli and negatively evaluate his or her own ability to deal with pain ) , and sense of control over pain were evaluated by the Brief Pain Inventory — Short Form Taiwanese version ( BPI-T ) , Pain and Opioid Analgesic Beliefs Scale — Cancer ( POABS-CA ) , and the Catastrophizing subscale and the sense of control over pain measure from the Coping Strategies Question naire ( CSQ ) . The results indicated that , after completing treatment , patients who had received structured pain education had significantly less pain intensity on average , negative pain beliefs regarding opioids , pain endurance beliefs , and pain catastrophizing than patients in the control group . In addition , patients in the pain education group showed a significant increase in their sense of control over pain . These preliminary results strongly suggest that structured pain education can effectively improve the pain experience of hospitalized cancer patients and should be further implemented clinical ly The persistence of negative attitudes towards cancer pain and its treatment suggests there is scope for identifying more effective pain education strategies . This r and omized controlled trial involving 189 ambulatory cancer patients evaluated an educational intervention that aim ed to optimize patients ' ability to manage pain . One week post-intervention , patients receiving the pain management intervention ( PMI ) had a significantly greater increase in self-reported pain knowledge , perceived control over pain , and number of pain treatments recommended . Intervention group patients also demonstrated a greater reduction in willingness to tolerate pain , concerns about addiction and side effects , being a " good " patient , and tolerance to pain relieving medication . The results suggest that targeted educational interventions that utilize individualized instructional techniques may alter cancer patient attitudes , which can potentially act as barriers to effective pain management CONTEXT Published literature has not defined the effectiveness of st and ardized educational tools that can be self-administered in the general oncology population with pain . OBJECTIVES We sought to determine if an educational intervention consisting of a video and /or booklet for adults with cancer pain could improve knowledge and attitudes about cancer pain management , pain levels , pain interference , anxiety , quality of life , and analgesic use . METHODS Eligible participants had advanced cancer , a pain score > /=2 of 10 in the last week , English proficiency , an estimated prognosis of more than one month , and were receiving outpatient cancer treatment at participating hospitals . Participants completed baseline assess
Output:
| CONCLUSIONS Patient-based pain educational programs may result in improvements of relevant patient-reported outcomes . |
MS212497 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE This study tested the efficacy of a multicomponent supermarket point-of-purchase intervention featuring in-person nutrition education on the nutrient composition of food purchases . DESIGN The design was a r and omized trial comparing the intervention with usual care ( no treatment ) . SETTING AND PARTICIPANTS A supermarket in a socioeconomically diverse region of Phoenix , AZ . One hundred fifty-three adult shoppers were recruited onsite . INTERVENTION The intervention consisted of brief shopping education by a nutrition educator and an explanation and promotion of a supermarket point-of-purchase healthful shopping program that included posted shelf signs identifying healthful foods , sample shopping lists , tips , and signage . MAIN OUTCOME MEASURES Outcomes included purchases of total , saturated , and trans fat ( grams/1,000 kcal ) , and fruits , vegetables , and dark-green/yellow vegetables ( servings/1,000 kcal ) derived through nutritional analysis of participant shopping baskets . ANALYSIS Analysis of covariance compared the intervention and control groups on food purchasing patterns while adjusting for household income . RESULTS The intervention result ed in greater purchasing of fruit and dark-green/yellow vegetables . No other group differences were observed . CONCLUSIONS AND IMPLICATION S Long-term evaluations of supermarket interventions should be conducted to improve the evidence base and to determine the potential for influence on food choices associated with decreased chronic disease incidence This study examined the direct and mediated impact of a self-administered , computer-based intervention on nutrition behavior , self-efficacy , and outcome expectations among supermarket food shoppers . The intervention , housed in kiosks in supermarkets and based on social cognitive theory , used tailored information and self-regulation strategies delivered in 15 brief weekly segments . The study sample ( N = 277 ) , stratified and r and omly assigned to treatment or control , was 96 % female , was 92 % White , had a median annual income of about $ 35,000 , and had a mean education of 14.78 ±2.11 years . About 12 % of the sample reported incomes of $ 20,000 or less , and about 20 % reported 12 years or fewer of education . Analysis of covariance immediately after intervention and at a 4- to 6-month follow-up found that treatment led to improved levels of fat , fiber , and fruits and vegetables . Treatment also led to higher levels of nutrition-related self-efficacy , physical outcome expectations , and social outcome expectations . Logistic regression analysis determined that the treatment group was more likely than the control group to attain goals for fat , fiber , and fruits and vegetables at posttest and to attain goals for fat at follow-up . Latent variable structural equation analysis revealed self-efficacy and physical outcome expectations mediated treatment effects on nutrition . In addition , physical outcome expectations mediated the effect of self-efficacy on nutrition outcomes . Implication s for future computer-based health promotion interventions are discussed OBJECTIVES This study examined the effects of pricing and promotion strategies on purchases of low-fat snacks from vending machines . METHODS Low-fat snacks were added to 55 vending machines in a convenience sample of 12 secondary schools and 12 worksites . Four pricing levels ( equal price , 10 % reduction , 25 % reduction , 50 % reduction ) and 3 promotional conditions ( none , low-fat label , low-fat label plus promotional sign ) were crossed in a Latin square design . Sales of low-fat vending snacks were measured continuously for the 12-month intervention . RESULTS Price reductions of 10 % , 25 % , and 50 % on low-fat snacks were associated with significant increases in low-fat snack sales ; percentages of low-fat snack sales increased by 9 % , 39 % , and 93 % , respectively . Promotional signage was independently but weakly associated with increases in low-fat snack sales . Average profits per machine were not affected by the vending interventions . CONCLUSIONS Reducing relative prices on low-fat snacks was effective in promoting lower-fat snack purchases from vending machines in both adult and adolescent population BACKGROUND Many question whether mass media , in the absence of other programming , can produce significant and sustained behavior change . METHODS The 1 % Or Less campaign in Wheeling , West Virginia ( population 35,000 ) , used paid advertising and public relations to encourage members of one community to switch from whole or 2 % milk ( high-fat milk ) to 1 % or fat-free milk ( low-fat milk ) . The study used a quasi-experimental research design with one intervention city and one comparison city . The effectiveness of the campaign was evaluated by collecting milk sales data from supermarkets and conducting pre- and post-intervention telephone surveys in intervention and comparison cities . RESULTS In the intervention city , low-fat milk sales increased from 29 % of overall milk sales before the campaign to 46 % of sales in the month following the campaign . The increase was maintained at the 6-month follow up . According to the telephone surveys , 34.1 % of high-fat-milk drinkers reported switching to low-fat milk in the intervention community compared with 3.6 % in the comparison community ( z = 13.1 , P < 0.0001 ) . CONCLUSIONS A media-only approach was sufficient to encourage a significant proportion of the people in one community to alter the dietary habit targeted by the intervention Objectives : The supermarket industry now services many customers through online food shopping over the Internet . The Internet shopping process offers a novel opportunity for the modification of dietary patterns . The aim of this study was to evaluate the effects on consumers ' purchases of saturated fat of a fully automated computerised system that provided real-time advice tailored to the consumers ' specific purchases recommending foods lower in saturated fat . Design : This study was a blinded , r and omised controlled trial . Setting : The study was conducted in Sydney , New South Wales , Australia . Participants : The participants were consumers using a commercial online Internet shopping site between February and June 2004 . Interventions : Individuals assigned to intervention received fully automated advice that recommended specific switches from selected products higher in saturated fat to alternate similar products lower in saturated fat . Participants assigned to control received general non-specific advice about how to eat a diet lower in saturated fat . Outcome Measures : The outcome measure was the difference in saturated fat ( grams per 100 g of food ) in shopping baskets between the intervention and control groups . Results : There were 497 r and omised participants , mean age 40 y , each shopping for an average of about three people . The amount of saturated fat in the foods purchased by the intervention group was 0.66 % lower ( 95 % confidence interval 0.48–0.84 , p < 0.001 ) than in the control group . The effects of the intervention were sustained over consecutive shopping episodes , and there was no difference in the average cost of the food bought by each group . Conclusions : Fully automated , purchase-specific dietary advice offered to customers during Internet shopping can bring about changes in food purchasing habits that are likely to have significant public health implication s. Because implementation is simple to initiate and maintain , this strategy would likely be highly cost-effective BACKGROUND Reducing fruit and vegetable ( F&V ) prices is a frequently considered policy to improve dietary habits in the context of health promotion . However , evidence on the effectiveness of this intervention is limited . OBJECTIVE The objective was to examine the effects of a 50 % price discount on F&Vs or nutrition education or a combination of both on supermarket purchases . DESIGN A 6-mo r and omized controlled trial within Dutch supermarkets was conducted . Regular supermarket shoppers were r and omly assigned to 1 of 4 conditions : 50 % price discounts on F&Vs , nutrition education , 50 % price discounts plus nutrition education , or no intervention . A total of 199 participants provided baseline data ; 151 ( 76 % ) were included in the final analysis . F&V purchases were measured by using supermarket register receipts at baseline , at 1 mo after the start of the intervention , at 3 mo , at 6 mo ( end of the intervention period ) , and 3 mo after the intervention ended ( 9 mo ) . RESULTS Adjusted multilevel models showed significantly higher F&V purchases ( per household/2 wk ) as a result of the price discount ( + 3.9 kg ; 95 % CI : 1.5 , 6.3 kg ) and the discount plus education intervention ( + 5.6 kg ; 95 % CI : 3.2 , 7.9 kg ) at 6 mo compared with control . Moreover , the percentage of participants who consumed recommended amounts of F&Vs ( ≥400 g/d ) increased from 42.5 % at baseline to 61.3 % at 6 mo in both discount groups ( P = 0.03 ) . Education alone had no significant effect . CONCLUSIONS Discounting F&Vs is a promising intervention strategy because it result ed in substantially higher F&V purchases , and no adverse effects were observed . Therefore , pricing strategies form an important focus for future interventions or policy . However , the long-term effects and the ultimate health outcomes require further investigation . This trial was registered at the IS RCT N Trial Register as number IS RCT N56596945 and at the Dutch Trial Register ( http://www.trialregister.nl/trialreg/index.asp ) as number NL22568.029.08 BACKGROUND Vending machines account for food sales and revenue in schools . We examined 3 strategies for promoting the sale of lower-calorie food products from vending machines in high schools in the Netherl and s. METHODS A school-based r and omized controlled trial was conducted in 13 experimental schools and 15 control schools . Three strategies were tested within each experimental school : increasing the availability of lower-calorie products in vending machines , labeling products , and reducing the price of lower-calorie products . The experimental schools introduced the strategies in 3 consecutive phases , with phase 3 incorporating all 3 strategies . The control schools remained the same . The sales volumes from the vending machines were registered . Products were grouped into ( 1 ) extra foods containing empty calories , for example , c and ies and potato chips , ( 2 ) nutrient-rich basic foods , and ( 3 ) beverages . They were also divided into favorable , moderately unfavorable , and unfavorable products . RESULTS Total sales volumes for experimental and control schools did not differ significantly for the extra and beverage products . Proportionally , the higher availability of lower-calorie extra products in the experimental schools led to higher sales of moderately unfavorable extra products than in the control schools , and to higher sales of favorable extra products in experimental schools where students have to stay during breaks . Together , availability , labeling , and price reduction raised the proportional sales of favorable beverages . CONCLUSION Results indicate that when the availability of lower-calorie foods is increased and is also combined with labeling and reduced prices , students make healthier choices without buying more or fewer products from school vending machines . Changes to school vending machines help to create a healthy school environment BACKGROUND The greater presence of supermarkets in low-income , high-minority neighborhoods has the potential to positively affect diet quality among those at greatest risk of obesity . In-store marketing strategies that draw attention to healthier products may be effective , sustainable , and scalable for improving diet quality and health . Few controlled studies of in-store marketing strategies to promote sales of healthier items in low-income , high-minority neighborhoods have been conducted . OBJECTIVE The objective of this study was to evaluate the effects of in-store marketing strategies to promote the purchase of specific healthier items in 5 product categories : milk , ready-to-eat cereal , frozen meals , in-aisle beverages , and checkout cooler beverages . DESIGN The design was a cluster-r and omized controlled trial conducted from 2011 to 2012 . Eight urban supermarkets in low-income , high-minority neighborhoods were the unit of r and omization , intervention , and analysis . Stores were matched on the percentage of sales from government food-assistance programs and store size and r and omly assigned to an intervention or control group . The 4 intervention stores received a 6-mo , in-store marketing intervention that promoted the sales of healthier products through placement , signage , and product availability strategies . The 4 control stores received no intervention and were assessment -only controls . The main outcome measure was weekly sales of the targeted products , which was assessed on the basis of the stores ' sales data . RESULTS Intervention stores showed significantly greater sales of skim and 1 % milk , water ( in aisle and at checkout ) , and 2 of 3 types of frozen meals compared with control store sales during the same time period . No differences were found between the stores in sales of cereal , whole or 2 % milk , beverages , or diet beverages . CONCLUSIONS These data indicate that straightforward placement strategies can significantly enhance the sales of healthier items in several food and beverage categories . Such strategies show promise for significant public health effects in communities with the greatest risk of obesity Although much evidence links dietary patterns with coronary heart disease , effective and economical methods for inducing dietary change in non clinical population s are needed to influence public health . This study was design ed as a preliminary investigation of the feasibility of conducting effective nutrition education campaigns in supermarket setting s. Eight supermarkets from a supermarket chain in the Twin Cities area participated . Four were assigned to an experimental condition in which educational material s consisting of posters , recipes , and brochures were placed in the dairy section during a 6-month period . Four other stores were assigned to a control condition and received no educational material s. Shoppers in experimental and control stores completed a nutrition survey pre- and post-intervention . In addition , sales data for 2
Output:
| The evidence of this review indicates that monetary incentives offered to customers for a short-term look promising in increasing purchase of healthier food options when the intervention is applied by itself in stores or supermarkets .
There was a lack of good quality studies addressing all other types of relevant point-of-sale interventions examining change in purchase and /or intake of healthier food options .
Conclusions A range of intervention types have been used at point-of-sale to encourage healthy purchasing and /or intake of healthier food options and to improve health outcomes . |
MS212498 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Three techniques for treatment of chronic venous incompetence on an out patients basis were compared in a r and omised study . One hundred thirty eight limbs ( 107 patients ) with superficial venous incompetence were r and omly treated with the dentist 's technique ( DT ) [ Group A , 44 limbs ] , compression sclerotherapy ( CS ) [ Group B , 45 limbs ] or the SAVAS ( section en Ambulatoire des Varices avec Sclérothérapie ) technique [ Group C , 49 limbs ] . Patients were evaluated and followed up ( every year for 4 years ) with ambulatory venous pressure ( AVP ) measurements and Quantum angiodynography ( colour duplex scanning ) . DT consisted in the section under local anesthesia of incompetent veins . CS was done injecting polidocanol 3 % with compression applied for 4 weeks . The SAVAS was done with a combination of DT and CS with section of the incompetent veins under local anesthesia and retro grade injection in the distal vein of polidocanol 3 % . With this type of injection only incompetent veins were perfused . After 4 years there was a significantly lower refilling time ( RT ) with AVP in the SAVAS group ( 21 sec ) . RT was 13 sec in group B and 16 in A. The number of significantly incompetent residual veins was in average 0.5 in the SAVAS group , significantly lower than in the other two groups . Also the average cost per treated limb was significantly lower in the SAVAS group ( 917 francs in comparison with 1100 in group A and 1211 in group B ) . In conclusion considering the four year follow up , the SAVAS technique is a more effective treatment of superficial venous incompetence , its hemodynamic value is superior to sclerotherapy alone and its costs are lower The influence of compression sclerotherapy upon hemostasis activation was investigated in 41 consecutive patients with lower extremity varices by serial measurement of thrombin-antithrombin III complexes ( TAT ) , D-dimer , fibrinogen and C-reactive protein ( CRP ) . Blood sampling was carried out before operation and on the 7th and 28th post-operative day in patients r and omly assigned to either the control group ( n = 18 ) , in which high ligation of sapheno-femoral junction and local excision of varices were performed , or the sclerotherapy group ( n = 23 ) in which the comparable surgical intervention and compression sclerotherapy using hypertonic saline were performed simultaneously . In both groups , the TAT , D-dimer and fibrinogen concentrations at day 7 were significantly elevated compared to the value before operation while CRP showed no significant change during the observation period . In the sclerotherapy group , higher incidence of superficial thrombosis was observed and the TAT concentration at day 7 was significantly higher than that in the control group ( p < 0.01 ) , and the TAT at day 28 was still significantly elevated compared to the pre-operative level ( p < 0.05 ) . However , no relationship between TAT and D-dimer concentrations and the extent of superficial thrombosis was observed . We conclude that compression sclerotherapy for lower extremity varices causes latent activation of coagulation system and can be a risk factor for venous thromboembolism 169 legs with primary varicose veins suitable for sclerotherapy were entered into the trial . At the time of injection they were r and omly allocated to be b and aged for three or six weeks ; patients allocated to the six-week group had their legs reb and aged after the first three week . Patients were subsequently assessed blind at three months and thereafter at yearly intervals PURPOSE The efficacy of sclerosing agents for the treatment of telangiectasias and reticular veins is well established . The injection of these agents is often associated with pain , and it is not uncommon for sclerotherapists to include lidocaine with the sclerosants in an attempt to reduce the pain associated with treatment . However , there are concerns that this may reduce the overall efficacy of the treatment because of dilution of the sclerosant . Patient comfort and overall outcome associated with treatment using HS with lidocaine ( LIDO ) versus that using HS alone was compared . METHODS Forty-two patients were prospect ively entered into the study and r and omized blindly to sclerotherapy with 23.4 % HS or 19 % LIDO . Study subjects and treating physicians were blinded to the injection solution used . Injection sites were chosen for veins ranging in size from 0.1 to 3 mm . Photographs of the area to be treated were taken , and the patients rated their pain . They were then observed at regular intervals for four months , and clinical data was collected . Thirty-five subjects completed the full follow-up period , and photographs of the injected area were taken again . Three investigators blinded to the treatment assignment then evaluated the photographs and scored the treatment efficacy according to a st and ardized system . RESULTS In the HS group , 61.9 % ( 13 of 21 ) patients rated their pain as none or mild , whereas 90.5 % ( 19 of 21 ) of patients in the LIDO group had no or mild discomfort . This difference is significant , with a P value of.034 . There was no difference in the overall efficacy of treatment between the two groups . The groups had similar rates of vein thrombosis and skin necrosis . CONCLUSION Although lidocaine is often used with sclerosing agents , there are no previous reports in the literature to evaluate its effectiveness in reducing the pain experienced by the patient . In this study , patients receiving LIDO experienced significantly less discomfort at the time of injection than patients who received HS alone . There were no differences in the effectiveness of treatment or in the incidence of complications between the two groups Following sclerotherapy of varicose veins , 158 limbs of 154 patients were r and omized to be b and aged with either crepe or Coban for 6 weeks each , or with Coban for 3 days only . Objective assessment of vein eradication and subjective evaluation of symptoms 3 months after completion of treatment showed no clear differences between these regimens . Significantly more discomfort was experienced with Coban than crepe when used for 6 weeks . It is suggested that , following sclerotherapy , 3 days is an adequate period of b and aging when using Coban . Such a policy would considerably reduce the inconvenience to patients during treatment Since thrombotic complications , such as superficial thrombophlebitis and subsequent skin pigmentation , are common after sclerotherapy , we conducted a study to evaluate whether combining sclerotherapy with ligation of varicose veins minimizes complications and what timing for sclerotherapy would be most beneficial-accompanying surgery or several weeks postsurgery . Surgical intervention and compression sclerotherapy were performed consecutively on 111 limbs ( group A ) , and sclerotherapy was performed 28 days after surgical intervention on 87 limbs ( group B ) . The volume of sclerosant used and the frequency of complications ( thrombus formation and pigmentation ) were analyzed . Plasma levels of thrombin-antithrombin III complex ( TAT ) and D-dimer ( DD ) , as markers for activation of coagulation , were compared . In group A , the total volume of sclerosant used in patients with complications was significantly higher than that in patients without complications . The frequency of thrombus formation and of pigmentation was significantly lower ( p < 0.01 ) in group B ( 10 % and 18 % , respectively ) than in group A ( 21 % and 37 % , respectively ) . The plasma levels of TAT 7 days after treatment were significantly lower in group B ( 3.4 + /- 1.2 mg/L ) than in group A ( 4.9 + /- 1.1 mg/L ) . Performing compression sclerotherapy 28 days after surgical intervention is effective for reducing complications and a good alternative for patients with an underlying hypercoagulable state BACKGROUND Sclerotherapy has traditionally been considered the gold st and ard of treatment for leg veins , but patient fear of multiple needle injections and side effects of treatment have fueled investigation into other treatment alternatives . As a result , vascular-specific laser and light sources have been developed in an effort to treat these vessels with minimal morbidity and improved efficacy . OBJECTIVE To compare the clinical efficacy of leg telangiectasia treatment with sodium tetradecyl sulfate sclerotherapy to long-pulsed 1064 nm Nd : YAG laser irradiation . METHODS A series of 20 patients with size-matched superficial telangiectases of the lower extremities were r and omly assigned to receive two consecutive monthly treatments with injectable sodium tetradecyl sulfate on one leg and long-pulsed 1064 nm Nd : YAG laser irradiation on the other . Patients were evaluated by two masked assessors at each treatment visit and at 1 and 3 months after treatment to assess clinical improvement within matched sites . RESULTS Leg telangiectases responded best to sclerotherapy in fewer treatment sessions than to long-pulsed 1064 nm Nd : YAG laser irradiation . The incidence of adverse sequelae was minimal and equivocal in both treatment groups . CONCLUSION Despite recent advances in laser technology for treatment of lower extremity telangiectases , sclerotherapy continues to offer superior clinical effect in the majority of cases . Laser leg vein treatment appears to be most beneficial in patients with telangiectatic matting , needle phobia , or sclerosant allergy BACKGROUND . Thirteen patients were treated with either sodium tetradecyl sulfate ( STS ) or glycerin to compare the efficacy and adverse sequelae of each agent . OBJECTIVE . To determine the relative safety and efficacy of two sclerosant solutions . METHODS . Each patient 's leg veins that were from 0.2 to 0.4 mm in diameter and that did not have incompetence from the saphenofemoral junction and whose feeding reticular veins had been already treated in a prior sclerotherapy session were r and omly treated with either 0.25 % STS or 72 % glycerin solution . Patients were evaluated from 2 to 6 months postsclerotherapy for overall clinical improvement and incidence of adverse sequelae . RESULTS . Glycerin was comparable to STS in discomfort of injection but demonstrated a significant decrease in bruising , swelling , and postprocedural hyperpigmentation . Glycerin also demonstrated a better , more rapid clearance of treated telangiectasias . Conclusions . Seventy‐two percent glycerin is a safe and effective sclerosant with fewer side effects and more rapid clearance of telangiectatic leg veins than STS BACKGROUND Although no r and omized controlled trial has assessed the effects of either compression sclerotherapy or ambulatory phlebectomy , both techniques are used to treat varicose veins worldwide . We performed a r and omized controlled trial to compare recurrence rates of varicose veins and complications after compression sclerotherapy and ambulatory phlebectomy . METHODS From September 1996 to October 1998 , we r and omly allocated 49 legs to compression sclerotherapy and 49 legs to ambulatory phlebectomy . Our primary outcome parameters were as follows : recurrence rates at 1 and 2 years and complications related to therapy . Eighty-two patients were included , of whom 16 were included with both of their legs . The number of treated legs was therefore 98 , but two patients were lost to follow-up . RESULTS One year recurrence amounted to 1 out of 48 for phlebectomy and 12 out of 48 for compression sclerotherapy ( P < 0.001 ) ; at 2 years , six additional recurrences were found , but then solely for compression sclerotherapy ( P < 0.001 ) . Significant differences in complications occurring more in phlebectomy than in compression sclerotherapy therapy were blisters , teleangiectatic matting , scar formation , and bruising from b and aging . CONCLUSION Our results show that ambulatory phlebectomy is an effective therapy for varicose veins of the leg . Recurrence rates are significantly lower than for compression sclerotherapy therapy . If varicose veins persist 4 weeks after compression sclerotherapy , it can be argued that to reduce the risk of future recurrence ambulatory phlebectomy should be considered as the better treatment option The study was planned to evaluate efficacy and costs of endovascular sclerotherapy ( ES ) in comparison with surgery and surgery associated with sclerotherapy in a prospect i ve ( 10-year follow-up ) , good- clinical - practice study . Patients with varicose veins and pure , superficial venous incompetence were included . Of the patients r and omized into the three groups 39 ( group A ) were treated with ES , 40 ( B ) with surgery + sclerotherapy , and 42 with surgery only ( C ) . Surgery consisted of ligation of the SFJ ( saphenofemoral junction ) and of incompetent veins detected with color duplex . Of the preselected 150 patients , 121 subjects entered the study ; 96 completed the 10-year follow-up ( mean age 52.6 ±6 years ; 51 men , 45 women ) . Dropouts were due to nonmedical problems . At 10 years no incompetence was observed in subjects treated with SPJ ligation ( B and C ) . In the ES group 18.8 % of the SFJs were patent and incompetent and in 43.8 % of limbs the distal ( below-knee ) venous system was still incompetent [ 16.1 % in the surgery + scle rotherapy group ( p < 0.05 ) and 36 % in the group treated with surgery only ( p < 0.05 vs B and 0.05 vs A ) ] . Color duplex of
Output:
| One study comparing sclerotherapy to GCS in pregnancy found that sclerotherapy improved symptoms and cosmetic appearance .
Three studies comparing sodium tetradecyl sulphate ( STD ) to alternative sclerosants found no significant differences in outcome or complication rates ; another study found that sclerotherapy with STD led to improved cosmetic appearance compared with polidocanol , although there was no difference in symptoms .
The degree and duration of elastic compression had no significant effect on varicose vein recurrence rates , cosmetic appearance or symptomatic improvement .
AUTHORS ' CONCLUSIONS Evidence from RCTs suggests that the choice of sclerosant , dose , formulation ( foam versus liquid ) , local pressure dressing , degree and length of compression have no significant effect on the efficacy of sclerotherapy for varicose veins . |
MS212499 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: PURPOSE A phase I/II trial to assess safety and efficacy of the combination bendamustine , rituximab , and lenalidomide ( BRL ) in patients with chronic lymphocytic leukemia ( CLL ) . PATIENTS AND METHODS Seventeen relapsed or refractory ( R/R ) and five previously untreated ( FL ) CLL patients were enrolled in the trial . In the R/R cohort , four different dose levels of lenalidomide ( maximum 15 mg/d ) were used . In the FL cohort , lenalidomide was dose escalated from 5 mg/d to 15 mg/d . Bendamustine was used at doses of 50 or 90 mg/m(2 ) for R/R or FL treatment , respectively . 375 mg/m(2 ) Rituximab were used for the first and 500 mg/m(2 ) for subsequent treatment courses . Treatment consisted of up to six courses of 28 d. RESULTS The maximal tolerable dose of lenalidomide was 5 mg/d . The response rate was 47.1 % in R/R and 60 % in FL patients . Median progression-free survival was 8.0 months . Median overall survival was 22.9 and 12.3 months , respectively , in R/R and FL patients . Grade 3/4 hematological toxicity was observed in 71.4 % , and severe infections in 47.6 % of patients . Due to high toxicity and low response rate of BRL , the trial was closed prematurely . CONCLUSION BRL was associated with a high toxicity rate , a high number of treatment interruptions , and a low remission rate . Therefore , BRL can not be considered an appropriate treatment option for patients with CLL N 1988 , THE National Cancer Institute-sponsored Working Group ( NCI-WC ) on chronic lymphocytic leukemia ( CLL ) published guidelines for the design and conduct of clinical trials in CLL with two major objectives : first , to facilitate comparisons of results of clinical trials in CLL by providing st and ardized eligibility , response , and toxicity criteria ; and , second , to encourage a framework on which to evaluate new scientific studies related to our increasing underst and ing of the biology and immunology of this disease . ' These guidelines were rapidly adopted by the majority of the clinical trials community , and were also used by the Food and Drug Administration during its evaluation process for the approval of fludarabine . The differences between these guidelines and those subsequently published by the International Working Group on CLL ( IWCLL ) , which were general- practice recommendations ' are listed in Table 1 . For diagnosis , the NCI-WC requires a lymphocyte count of 5 X loy & which is lower than the 10 X 109/L required by the IWCLL , unless the lymphocytes are B cells and the bone marrow is involved . To be considered a complete remission ( CR ) , the NCI-WC criteria specify that less than 30 % lymphocytes must be present in the bone marrow , with a recommendation that the clinical significance of lymphoid nodules be assessed prospect ively ( Table 1 ) ; the IWCLL allows focal infiltrates or nodules in the bone marrow aspirate and biopsy for CR . The IWCLL uses a shift in clinical stage as the sole index of partial remission ( PR ) , whereas the NCI-WC provides more specific criteria and recommends validation of the relevance of stage shift . The major differences were the well-defined criteria in the NCI guidelines regarding when to initiate therapy , hematologic toxicity , and other important components for clinical trials design . The purpose of this report is to present those revisions as considered necessary in view of advances in the past 8 years . Many of these revisions evolved as the guidelines were used in a systematic fashion in large clinical trials and , also , with the experience following the use of newer , more effective agents , such as fludarabine . " ' Although this report will focus on those changes recommended by the NCI-sponsored CLL Working Group , it will include sufficient details from the original guidelines so that the reader would find it a complete document by itself without having to refer to the older version PURPOSE Patients with relapsed or refractory chronic lymphocytic leukemia ( CLL ) have profound immune defects and limited treatment options . Given the dramatic activity of lenalidomide in other B-cell malignancies and its pleotropic immunomodulatory effects , we conducted a phase II trial of this agent in CLL . PATIENTS AND METHODS Patients with relapsed or refractory B-cell CLL ( B-CLL ) were eligible if they required treatment as per the National Cancer Institute Working Group 1996 guidelines . Lenalidomide was administered orally at 25 mg on days 1 through 21 of a 28-day cycle . Response was assessed after each cycle . Patients were to continue treatment until disease progression , unacceptable toxicity , or complete remission . Rituximab was added to lenalidomide on disease progression . RESULTS Forty-five patients were enrolled , with a median age of 64 years . Sixty-four percent of the patients had Rai stage III or IV disease , and 51 % were refractory to fludarabine . The overall response rate was 47 % , with 9 % of the patients attaining a complete remission . Fatigue , thrombocytopenia , and neutropenia were the most common adverse effects noted in 83 % , 78 % , and 78 % of the patients , respectively . CONCLUSION Lenalidomide is clinical ly active in patients with relapsed or refractory B-CLL . These findings are encouraging and warrant further investigation of this agent in the treatment of this disorder Patients with chronic lymphocytic lymphoma ( CLL ) with high-risk cytogenetics [ del(11q)(q22.3 ) or del(17p)(p13.1 ) ] have limited therapeutic options and their prognosis remains poor . This analysis was conducted to determine the clinical activity of lenalidomide in patients with high-risk disease . Relapsed/refractory patients with CLL enrolled in a phase II clinical trial who had del(11q)(q22.3 ) or del(17p)(p13.1 ) were included in this analysis . Patients received single agent lenalidomide for 21 days of the 4 week treatment cycle . The overall response rate among patients with high-risk cytogenetics was 38 % , with 19 % of patients achieving a complete response . Median progression-free survival was 12.1 months , which is higher than demonstrated with other agents in comparable patient population s. In addition , the estimated 2-year survival probability was 58 % , demonstrating that the responses achieved with lenalidomide are durable , even in patients with CLL with high-risk disease with poor risk cytogenetics Adequate dosing of lenalidomide in Chronic Lymphocytic Leukemia ( CLL ) remains unclear . This study determined maximum tolerated dose ( MTD ) in relapsed CLL patients ( Cohort A ) and patients achieving a partial response ( PR ) or better to recent therapy ( Cohort B ) . Thirty-seven patients were enrolled . MTD was 2.5 mg followed by 5.0 mg continuous . In Cohort A , tumor flare grade 1 - 2 occurred in 15 patients ( 50 % ) and grade 3 in 1 patient ( 3 % ) . Cohort A had 19 of 23 evaluable ( 83 % ) patients , 4 PR ( 17 % ) and 15 ( 65 % ) stable disease ( SD ) , Cohort B had 6 of 7 patients ( 86 % ) with SD . Despite overall response rate not being high , many patients remained on therapy several months with SD A quantitative systematic review , or meta- analysis , uses statistical methods to combine the results of multiple studies . Meta-analyses have been done for systematic review s of therapeutic trials , diagnostic test evaluations , and epidemiologic studies . Although the statistical methods involved may at first appear to be mathematically complex , their purpose is simple : They are trying to answer four basic questions . Are the results of the different studies similar ? To the extent that they are similar , what is the best overall estimate ? How precise and robust is this estimate ? Finally , can dissimilarities be explained ? This article provides some guidance in underst and ing the key technical aspects of the quantitative approach to these questions . We have avoided using equations and statistical notations ; interested readers will find implementations of the described methods in the listed references . We focus here on the quantitative synthesis of reports of r and omized , controlled , therapeutic trials because far more meta-analyses on therapeutic studies than on other types of studies have been published . For practical reasons , we present a stepwise description of the tasks that are performed when statistical methods are used to combine data . These tasks are 1 ) deciding whether to combine data and defining what to combine , 2 ) evaluating the statistical heterogeneity of the data , 3 ) estimating a common effect , 4 ) exploring and explaining heterogeneity , 5 ) assessing the potential for bias , and 6 ) presenting the results . Deciding Whether To Combine Data and Defining What To Combine By the time one performs a quantitative synthesis , certain decisions should already have been made about the formulation of the question and the selection of included studies . These topics were discussed in two previous articles in this series [ 1 , 2 ] . Statistical tests can not compensate for lack of common sense , clinical acumen , and biological plausibility in the design of the protocol of a meta- analysis . Thus , a reader of a systematic review should always address these issues before evaluating the statistical methods that have been used and the results that have been generated . Combining poor- quality data , overly biased data , or data that do not make sense can easily produce unreliable results . The data to be combined in a meta- analysis are usually either binary or continuous . Binary data involve a yes/no categorization ( for example , death or survival ) . Continuous data take a range of values ( for example , change in diastolic blood pressure after antihypertensive treatment , measured in mm Hg ) . When one is comparing groups of patients , binary data can be summarized by using several measures of treatment effect that were discussed earlier in this series [ 3 ] . These measures include the risk ratio ; the odds ratio ; the risk difference ; and , when study duration is important , the incidence rate . Another useful clinical measure , the number needed to treat ( NNT ) , is derived from the inverse of the risk difference [ 3 ] . Treatment effect measures , such as the risk ratio and the odds ratio , provide an estimate of the relative efficacy of an intervention , whereas the risk difference describes the intervention 's absolute benefit . The various measures of treatment effect offer complementary information , and all should be examined [ 4 ] . Continuous data can be summarized by the raw mean difference between the treatment and control groups when the treatment effect is measured on the same scale ( for example , diastolic blood pressure in mm Hg ) , by the st and ardized mean difference when different scales are used to measure the same treatment effect ( for example , different pain scales being combined ) , or by the correlation coefficients between two continuous variables [ 5 ] . The st and ardized mean difference , also called the effect size , is obtained by dividing the difference between the mean in the treatment group and the mean in the control group by the SD in the control group . Evaluating the Statistical Heterogeneity of the Data This step is intended to answer the question , Are the results of the different studies similar ( homogeneous ) ? It is important to answer this question before combining any data . To do this , one must calculate the magnitude of the statistical diversity ( heterogeneity ) of the treatment effect that exists among the different sets of data . Statistical diversity can be thought of as attributable to one or both of two causes . First , study results can differ because of r and om sampling error . Even if the true effect is the same in each study , the results of different studies would be expected to vary r and omly around the true common fixed effect . This diversity is called the within- study variance . Second , each study may have been drawn from a different population , depending on the particular patients chosen and the interventions and conditions unique to the study . Therefore , even if each study enrolled a large patient sample , the treatment effect would be expected to differ . These differences , called r and om effects , describe the between- study variation with regard to an overall mean of the effects of all of the studies that could be undertaken . The test most commonly used to assess the statistical significance of between- study heterogeneity is based on the chi-square distribution [ 6 ] . It provides a measure of the sum of the squared differences between the results observed and the results expected in each study , under the assumption that each study estimates the same common treatment effect . A large total deviation indicates that a single common treatment effect is unlikely . Any pooled estimate calculated must account for the between- study heterogeneity . In practice , this test has low sensitivity for detecting heterogeneity , and it has been suggested that a liberal significance level , such as 0.1 , should be used [ 6 ] . Estimating a Common Effect The questions that this step tries to answers are , 1 ) To the extent that data are similar , what is their best common point estimate of a therapeutic effect , and 2 ) how precise is this estimate ? The mathematical process involved in this step generally involves combining ( pooling ) the results of different studies into an overall estimate . Compared with the results of individual studies , pooled results can increase statistical power and lead to more precise estimates of treatment effect . Each study is given a weight according to the precision of its results . The rationale is that studies with narrow CIs should be weighted more heavily than studies with greater uncertainty . The precision is generally expressed by the inverse of the variance of the estimate of each study . The variance has two components : the variance of the individual study and the variance between different studies . When the between- study variance is found to be or assumed to be zero , each study is simply weighted by the inverse of its own variance , which is a function of the study size and the number of events in the study . This approach characterizes a fixed-effects model , as exemplified by the Mantel-Haenszel method [ 7 , 8 ] or the Peto method [ 9 ] for dichotom
Output:
| Our finding demonstrated that lenalidomide plus anti-CD20 mAbs could be an efficient therapy regimen for relapsed/refractory CLL patients , especially for those with high-risk cytogenetic factor |
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