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MS213200 | ***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 Veterans who served in Operation Enduring Freedom ( OEF ) and Operation Iraqi Freedom ( OIF ) commonly experience alcohol misuse and symptoms of posttraumatic stress disorder ( PTSD ) following their return from deployment to a war zone . We conducted a r and omized clinical trial to evaluate the efficacy of a newly developed , 8-module , self-management web intervention ( VetChange ) based on motivational and cognitive-behavioral principles to reduce alcohol consumption , alcohol-related problems , and PTSD symptoms in returning combat veterans . METHOD Six hundred participants , recruited through targeted Facebook ads , were r and omized to either an Initial Intervention Group ( IIG ; n = 404 ) or a Delayed Intervention Group ( DIG ; n = 196 ) that waited 8 weeks for access to VetChange . Primary outcome measures were Drinks per Drinking Day , Average Weekly Drinks , Percent Heavy Drinking Days , and PTSD symptoms . Intent-to-treat analyses compared changes in outcome measures over time between IIG and DIG as well as within-group changes . RESULTS IIG participants demonstrated greater reductions in drinking ( p < .001 for each measure ) and PTSD symptoms ( p = .009 ) between baseline and end-of-intervention than did DIG participants between baseline and the end of the waiting period . DIG participants showed similar improvements to those in IIG following participation in VetChange . Alcohol problems were also reduced within each group between baseline and 3-month follow-up . CONCLUSIONS Results indicate that VetChange is effective in reducing drinking and PTSD symptoms in OIF/OEF veterans . Further studies of VetChange are needed to assess web-based recruitment and retention methods and to determine VetChange 's effectiveness in demographic and clinical sub- population s of returning veterans Background Guided self-help interventions for PTSD ( post-traumatic stress disorder ) are a promising tool for the dissemination of contemporary psychological treatment . Objective This study investigated the efficacy of the Chinese version of the My Trauma Recovery ( CMTR ) website . Methods In an urban context , 90 survivors of different trauma types were recruited via Internet advertisements and allocated to a r and omized controlled trial ( RCT ) with a waiting list control condition . In addition , in a rural context , 93 survivors mainly of the 2008 Sichuan earthquake were recruited in-person for a parallel RCT in which the website intervention was conducted in a counseling center and guided by volunteers . Assessment was completed online on a professional Chinese survey website . The primary outcome measure was the Post-traumatic Diagnostic Scale ( PDS ) ; secondary outcome measures were Symptom Checklist 90-Depression ( SCL-D ) , Trauma Coping Self-Efficacy Scale ( CSE ) , Post-traumatic Cognitive Changes ( PCC ) , and Social Functioning Impairment ( SFI ) question naires adopted from the My Trauma Recovery website . Results For the urban sample , findings indicated a significant group × time interaction in post-traumatic symptom severity ( F 1,88=7.65 , P=.007 ) . CMTR reduced post-traumatic symptoms significantly with high effect size after one month of treatment ( F 1,45=15.13 , Cohen ’s d=0.81 , P<.001 ) and the reduction was sustained over a 3-month follow-up ( F 1,45=17.29 , Cohen ’s d=0.87 , P<.001 ) . In the rural sample , the group × time interaction was also significant in post-traumatic symptom severity ( F 1,91=5.35 , P=.02 ) . Post-traumatic symptoms decreased significantly after treatment ( F 1,48=43.97 , Cohen ’s d=1.34 , P<.001 ) and during the follow-up period ( F 1,48=24.22 , Cohen ’s d=0.99 , P<.001 ) . Additional outcome measures ( post-traumatic cognitive changes , depression ) indicated a range of positive effects , in particular in the urban sample ( group × time interactions : F 1,88=5.32 - 8.37 , all Ps<.03 ) , contributing to the positive evidence for self-help interventions . Differences in the effects in the two RCTs are exploratorily explained by sociodemographic , motivational , and setting feature differences between the two sample s. Conclusions These findings give support for the short-term efficacy of CMTR in the two Chinese population s and contribute to the literature that self-help Web-based programs can be used to provide mental health help for traumatized persons . Trial Registration Australia New Zeal and Clinical Trials Registry ( ANZCTR ) : ACTRN12611000951954 ; https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?ACTRN=12611000951954 ( Archived by WebCite at http://www.webcitation.org/6G7WyNODk ) Online therapy offers many advantages over face-to-face therapy . Interapy includes psychoeducation , screening , effect measures , and a protocol -driven treatment via the Internet for people suffering from posttraumatic stress . The present article reports the results of a controlled trial on the Internet-driven treatment of posttraumatic stress and grief in a group of people who manifested mild to relatively severe trauma symptoms . Participants in the treatment condition ( n=69 ) improved significantly more than participants in the waiting-list control condition ( n=32 ) on trauma-related symptoms and general psychopathology . The effect sizes were large . On most subscales , more than 50 % of the treated participants showed reliable change and clinical ly significant improvement , with the highest percentages being found for depression and avoidance Background Posttraumatic stress disorder ( PTSD ) develops in 10 - 20 % of injury patients . We developed a novel , self-guided Internet-based intervention ( called Trauma TIPS ) based on techniques from cognitive behavioral therapy ( CBT ) to prevent the onset of PTSD symptoms . Objective To determine whether Trauma TIPS is effective in preventing the onset of PTSD symptoms in injury patients . Methods Adult , level 1 trauma center patients were r and omly assigned to receive the fully automated Trauma TIPS Internet intervention ( n=151 ) or to receive no early intervention ( n=149 ) . Trauma TIPS consisted of psychoeducation , in vivo exposure , and stress management techniques . Both groups were free to use care as usual ( non protocol ized talks with hospital staff ) . PTSD symptom severity was assessed at 1 , 3 , 6 , and 12 months post injury with a clinical interview ( Clinician-Administered PTSD Scale ) by blinded trained interviewers and self-report instrument ( Impact of Event Scale — Revised ) . Secondary outcomes were acute anxiety and arousal ( assessed online ) , self-reported depressive and anxiety symptoms ( Hospital Anxiety and Depression Scale ) , and mental health care utilization . Intervention usage was documented . Results The mean number of intervention logins was 1.7 , SD 2.5 , median 1 , interquartile range ( IQR ) 1 - 2 . Thirty-four patients in the intervention group did not log in ( 22.5 % ) , 63 ( 41.7 % ) logged in once , and 54 ( 35.8 % ) logged in multiple times ( mean 3.6 , SD 3.5 , median 3 , IQR 2 - 4 ) . On clinician-assessed and self-reported PTSD symptoms , both the intervention and control group showed a significant decrease over time ( P<.001 ) without significant differences in trend . PTSD at 12 months was diagnosed in 4.7 % of controls and 4.4 % of intervention group patients . There were no group differences on anxiety or depressive symptoms over time . Post hoc analyses using latent growth mixture modeling showed a significant decrease in PTSD symptoms in a subgroup of patients with severe initial symptoms ( n=20 ) ( P<.001 ) . Conclusions Our results do not support the efficacy of the Trauma TIPS Internet-based early intervention in the prevention of PTSD symptoms for an unselected population of injury patients . Moreover , uptake was relatively low since one-fifth of individuals did not log in to the intervention . Future research should therefore focus on innovative strategies to increase intervention usage , for example , adding gameplay , embedding it in a blended care context , and targeting high-risk individuals who are more likely to benefit from the intervention . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 57754429 ; http://www.controlled-trials.com/IS RCT N57754429 ( Archived by WebCite at http://webcitation.org/6FeJtJJyD ) A total of 117 depressed clients , stratified for severity , completed 8 or 16 sessions of manualized treatment , either cognitive-behavioral psychotherapy ( CB ) or psychodynamic-interpersonal psychotherapy ( PI ) . Each of 5 clinician-investigators treated clients in all 4 treatment conditions . On most measures , CB and PI were equally effective , irrespective of the severity of depression or the duration of treatment . However , there was evidence of some advantage to CB on the Beck Depression Inventory ( Beck , Ward , Mendelson , Mock , & Erbaugh , 1961 ) . There was no evidence that CB 's effects were more rapid than those of PI , nor did the effects of each treatment method vary according to the severity of depression . There was no overall advantage to 16-session treatment over 8-session treatment . However , those presenting with relatively severe depression improved substantially more after 16 than after 8 sessions On-line therapy offers many advantages over face-to-face setting s. Interapy includes psycho-education , screening , effect measures and protocol -driven treatment via the Internet for clients . The present paper reports the results of a controlled trial on the Interapy treatment of posttraumatic stress and grief in students , gaining course credits . The participants in the experimental condition ( n = 13 ) improved significantly than the participants in the waiting-list control condition ( n = 12 ) , on trauma-related symptoms and general psychopathology . The effect sizes were large . Eighty percent of the treated participants showed clinical ly significant improvement after treatment . The possibilities for future research with Interapy , including studies into moderating variables , are discussed BACKGROUND Posttraumatic stress disorder ( PTSD ) is a severe and disabling condition and few receive appropriate care . Internet-based treatment of PTSD shows promise in reducing barriers to care and preliminary evidence suggests it is efficacious in treating symptoms of PTSD . METHODOLOGY Forty-two individuals with a diagnosis of PTSD confirmed by clinician interview completed a r and omized controlled comparison of Internet-based cognitive behavioral therapy ( CBT ) with a waitlist control condition . PRINCIPLE FINDINGS Large pre- to posttreatment effect sizes ( ESs ) were found for the Treatment group on measures of PTSD symptoms , depression , anxiety , and disability . A small between-group ES was found for PTSD symptoms and moderate between-group ESs were found for depression , anxiety , and disability . CONCLUSIONS Results provide preliminary support for Internet-based CBT as an efficacious treatment for individuals with a confirmed primary diagnosis of PTSD This study was an open trial evaluation of a 10-week therapist-assisted cognitive behavior therapy ( CBT ) internet intervention ( PTSD Online ) undertaken with people with a primary clinical diagnosis of posttraumatic stress disorder ( PTSD ) ( n=22 ) at pre- assessment . Participants were re-assessed at post- assessment and 3-month follow-up . Significant improvements on PTSD severity ratings and related PTSD symptomatology were observed at post- assessment and maintained at 3-month follow-up . At post- assessment , 69.2 % of the sample showed clinical ly significant improvement and 77 % of the sample at follow-up assessment . Non-significant , yet improved , change was observed on all other general psychological measures . Overall , treatment satisfaction was good ( 69 % ) , participant therapeutic alliance ratings were high ( 87.5 % ) , and the average total therapist time required was 194.5 min . PTSD Online appears to be an efficacious treatment option for people with PTSD that can be provided entirely remotely , with far less therapist time than traditional face-to-face treatment , and without compromising therapeutic alliance BACKGROUND Compared to those with depression alone , depressed patients with posttraumatic stress disorder ( PTSD ) experience more severe psychiatric symptomatology and factors that complicate treatment . OBJECTIVE To estimate PTSD prevalence among depressed military veteran primary care patients and compare demographic/illness characteristics of PTSD screen-positive depressed patients ( MDD-PTSD+ ) to those with depression alone ( MDD ) . DESIGN Cross-sectional comparison of MDD patients versus MDD-PTSD+ patients . PARTICIPANTS Six hundred seventy-seven r and omly sample d depressed patients with at least 1 primary care visit in the previous 12 months . Participants composed the baseline sample of a group r and omized trial of collaborative care for depression in 10 VA primary care practice s in 5 states . MEASUREMENTS The Patient Health Question naire-9 assessed MDD . Probable PTSD was defined as a Primary Care PTSD Screen ≥ 3 . Regression-based techniques compared MDD and MDD-PTSD+ patients on demographic/illness characteristics . RESULTS Thirty-six percent of depressed patients screened positive for PTSD . Adjusting for sociodemographic differences and physical
Output:
| The findings of this systematic review and meta- analysis show that iCBT is an effective treatment for individuals with PTSD and comorbid depressive symptoms . |
MS213201 | ***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: Therapeutic trials often attempt to “ blind ” patient and investigator to the true nature of treatments received , reducing the influences of conscious or subconscious prejudices . In drug trials , this is accomplished with placebo tablets , but blinding in trials of physical treatments is more problematic . This issue arose in a clinical trial of transcutaneous electrical nerve stimulation ( TENS ) for patients with chronic low back pain . Several study design features were incorporated to promote blinding : use of sham TENS units visually identical with real units , exclusion of potential subjects with previous TENS experience , avoidance of a crossover design and use of identical visit frequency , instructions and modifications in electrode placement . Subjects were asked not to discuss treatments with the clinicians who performed outcome assessment s. Both patients and clinicians were asked to guess actual treatment assignments at the trial 's end . Every patient in the true TENS group believed the unit was functioning properly , but the degree of certainty varied . In the sham TENS group , 84 % also believed they had functioning units , but their certainty was significantly less than in the active treatment group . Differences in patient perceptions did not affect compliance , as the two groups had similar dropout rates , appointment compliance , days of TENS use and daily duration of TENS use . Clinicians guessed treatments correctly 61 % of the time ( as opposed to 50 % expected by chance ) , again suggesting partial success in blinding . These efforts at blinding may partly explain the negative trial results for TENS efficacy . We conclude that complete blinding is difficult to achieve because of sensory difference in treatment and unintended communication between patient and examiner . Nonetheless , trials of physical treatments can achieve partial blinding with the techniques described here , and the success of blinding can be assessed with simple questions at study completion The effect of active h and exercise and warm wax treatment was evaluated in 52 rheumatoid arthritis patients r and omized into four groups : ( 1 ) both exercise and wax bath , ( 2 ) exercise only , ( 3 ) wax bath only , and ( 4 ) controls . Treatment was given three times a week for 4 weeks . Deficits in flexion and extension in digits II-V bilaterally , grip function , grip strength , pain , and stiffness were measured before and after the treatment period . The control group was measured at corresponding times . Wax bath treatment followed by active h and exercise result ed in significant improvements of range of motion ( ROM ) and grip function . Active h and exercise alone reduced stiffness and pain with nonresisted motion and increased ROM . Wax bath alone had no significant effect OBJECTIVE To evaluate the effects of local application of ice chips , ligno-paraffin , short-wave diathermy , and nitrogen-cold air on skin and intraarticular temperature . METHODS Forty-two healthy subjects were divided into 4 treatment groups . A temperature probe was inserted into the knee joint cavity and another placed on the overlying skin , and changes in temperature over 3 hours , by treatment group , were recorded . RESULTS The mean skin surface temperature dropped from 27.9 degrees C to 11.5 degrees C after application of ice chips , and from 28.8 degrees C to 13.8 degrees C after application of cold air . The mean intraarticular temperature decreased from 31.9 degrees C to 22.5 degrees C and from 32.9 degrees C to 28.8 degrees C , respectively , after these 2 treatments . Shortwave diathermy increased skin temperature by 2.4 degrees C ; intraarticular temperature was increased only 1.4 degrees C by short-wave diathermy . Treatment with ligno-paraffin increased the skin surface temperature 8.9 degrees C ; the temperature in the joint cavity was increased 3.5 degrees C. CONCLUSION The use of short-wave diathermy and superficial heat packs in the treatment of patients with arthritis may potentially cause harm by increasing intraarticular temperature . This may have major implication s regarding treatment policy for patients with arthritis OBJECTIVE To evaluate and compare the effects of locally applied heat and cold treatments on skin and intraarticular temperature in patients with arthritis . METHODS Thirty-nine patients with arthritis of the knee were divided at r and om into 4 treatment groups ( ice chips , nitrogen cold air , ligno-paraffin , and placebo short wave ) . A temperature probe was inserted into the knee joint cavity and another placed on the overlying skin , and changes in temperature over 3 hours were recorded for each treatment group . RESULTS The mean temperature of the surface of the skin dropped from 32.2 degrees C to 16.0 degrees C after application of ice chips and from 32.6 degrees C to 9.8 degrees C after application of nitrogen cold air ; the mean intraarticular temperature decreased from 35.5 degrees C to 29.1 degrees C and from 35.8 degrees C to 32.5 degrees C , respectively , after these treatments . Treatment with ligno-paraffin increased the surface temperature by 7.5 degrees C and the temperature in the joint cavity by 1.7 degrees C. No significant changes were observed with placebo short wave diathermy . CONCLUSION The traditional model , that intraarticular temperature is decreased by superficial heat and increased by superficial cold , must be discarded . In arthritis patients , intraarticular temperature is increased by superficial heat and decreased by superficial cold . This has clear consequences for treatment policy Ninety consecutive patients undergoing primary knee arthroplasty received local cryotherapy 72 hours after surgery for pain relief . Thermal-pad circulating temperatures were r and omly assigned to 50 degrees , 60 degrees , or 70 degrees F ( room temperature ) . Pain relief was monitored using patient-controlled analgesia machines . The amount of morphine received and number of attempts per hour were statistically analyzed with relation to temperature group , age , sex , weight , side , and diagnosis . The amount of morphine injected was positively correlated to the number of attempts per hour and moderately correlated to body weight . There was no correlation between thermal-pad temperature or any other parameter and the amount of morphine injected after surgery Superficial heat and cold are commonly used therapeutic methods in patients with rheumatoid arthritis . Both procedures have analgesic effect . In 30 in patients with rheumatoid arthritis the pain threshold was measured before and after warm bath and ice massage . Rheumatoid patients had significantly lower pain threshold compared to the healthy subjects in normal circumstances . Heat and cold remarkably raise the pain threshold right after the application . The pain threshold is also raised 10 and 30 min after cryotherapy , but not after the warm bath . Between investigated groups there were no statistically significant differences in the pain threshold values in any observed time . We consider that both methods have a reasonable place in the therapy of rheumatoid arthritis
Output:
| There was no effect on objective measures of disease activity ( including inflammation , pain and x-ray measured joint destruction ) of either ice versus control or heat versus control .
There was no difference in patient preference for heat or ice .
No harmful effects of ice or heat were reported .
REVIEW ER 'S CONCLUSIONS Since patients enjoy thermotherapy , and there are no harmful effects , thermotherapy should be recommended as a therapy which can be applied at home as needed to relieve pain .
There is no need for further research on the effects of heat or cold for RA |
MS213202 | ***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 describe the prevalence of hyperopia and associated factors in a representative sample of Australian schoolchildren 6 and 12 years old . DESIGN Population -based cross-sectional study . PARTICIPANTS Schoolchildren ages 6 ( n = 1765 ) and 12 ( n = 2353 ) from 55 r and omly selected schools across Sydney . METHODS Detailed eye examinations included cycloplegic autorefraction , ocular biometry , cover testing , and dilated fundus examination . Information on birth and medical history were obtained from a parent question naire . MAIN OUTCOME MEASURES Moderate hyperopia defined as spherical equivalent ( SE ) refraction of > or = + 2.00 diopters ( D ) , and eye conditions including amblyopia , strabismus , astigmatism , and anisometropia . RESULTS Prevalences of moderate hyperopia among children ages 6 and 12 were 13.2 % and 5.0 % , respectively ; it was more frequent in children of Caucasian ethnicity ( 15.7 % and 6.8 % , respectively ) than in children of other ethnic groups . Compared with children without significant ametropia ( -0.49 < or = SE refraction < or = + 1.99 D ) , the prevalence of eye conditions including amblyopia , strabismus , abnormal convergence , and reduced stereoacuity was significantly greater in children with moderate hyperopia ( all Ps < 0.01 ) . Maternal smoking was significantly associated with moderate hyperopia among 6-year-olds ( P = 0.03 ) , but this association was borderline among 12-year-olds ( P = 0.055 ) . Early gestational age ( < 37 weeks ) and low birth weight ( < 2500 g ) were not statistically significant predictors of moderate hyperopia in childhood . CONCLUSIONS Moderate hyperopia was strongly associated with many common eye conditions , particularly amblyopia and strabismus , in older children . Birth parameters did not predict moderate hyperopia PURPOSE To determine the prevalence of refractive error types in Singaporean Chinese children aged 6 to 72 months . METHODS The Strabismus , Amblyopia and Refractive Error in Singaporean Children ( STARS ) is a population -based study in southwest Singapore . Door-to-door recruitment of participants was used , with disproportionate r and om sampling in 6-month increments . Parental question naires were administered . Participant eye examinations included logMAR visual acuity , cycloplegic autorefraction , and ocular biometry . Overall and age-specific prevalences of myopia ( spherical equivalence [ SE ] < or= -0.50 D ) , high myopia ( SE < or= -6.00 D ) , hyperopia ( SE > or= + 3.00 D ) , astigmatism ( cylinder > or= + 1.50 D ) , and anisometropia ( SE difference between each eye > or=2.00 D ) were calculated . RESULTS A total of 3009 children were examined ( participation rate , 72.3 % ) . Right eye ( OD ) cycloplegia data were available for 1375 boys and 1264 girls ( mean age , 41 months ) . Mean OD SE was + 0.69 D ( SD 1.15 ) . Overall myopia prevalence was 11.0 % with no variance between the sexes ( P = 0.91 ) . The prevalence of high myopia ( at least -6.00 D ) was 0.2 % . The prevalences of hyperopia , astigmatism , and anisometropia were 1.4 % , 8.6 % , and 0.6 % , respectively . Most astigmatism ( > 95 % ) was with-the-rule ( cylinder axes between 1 degrees and 15 degrees or 165 degrees and 180 degrees ) . Myopia was present in 15.8 % , 14.9 % , 20.2 % , 8.6 % , 7.6 % , and 6.4 % of children aged 6 to 11 , 12 to 23 , 24 to 35 , 36 to 47 , 48 to 59 , and 60 to 72 months , respectively . Prevalence increased with age for astigmatism ( P < 0.001 ) , but not for hyperopia or anisometropia ( P = 0.55 and P = 0.37 ) , respectively . CONCLUSIONS The prevalences of myopia and astigmatism in young Singaporean Chinese children are high , but that of hyperopia is low . Age effects were observed for each refractive error category , but differences between the sexes were not significant . Age-related variation in myopia prevalence may be influenced by ocular development , environment , and /or testability PURPOSE To describe the methodology , sampling strategy and preliminary results for the Aston Eye Study ( AES ) , a cross-sectional study to determine the prevalence of refractive error and its associated ocular biometry in a large multi-racial sample of school children from the metropolitan area of Birmingham , Engl and . METHODS A target sample of 1700 children aged 6 - 7 years and 1200 aged 12 - 13 years is being selected from Birmingham schools selected r and omly with stratification by area deprivation index ( a measure of socio-economic status ) . Schools with pupils predominantly ( > 70 % ) from a single race are excluded . Sample size calculations account for the likely participation rate and the clustering of individuals within schools . Procedures involve st and ardised protocol s to allow for comparison with international population -based data . Visual acuity , non-contact ocular biometry ( axial length , corneal radius of curvature and anterior chamber depth ) and cycloplegic autorefraction are measured in both eyes . Distance and near oculomotor balance , height and weight are also assessed . Question naires for parents and older children will allow the influence of environmental factors on refractive error to be examined . RESULTS Recruitment and data collection are ongoing ( currently N=655 ) . Preliminary cross-sectional data on 213 South Asian , 44 black African Caribbean and 70 white European children aged 6 - 7 years and 114 South Asian , 40 black African Caribbean and 115 white European children aged 12 - 13 years found myopia prevalence of 9.4 % and 29.4 % for the two age groups respectively . A more negative mean spherical equivalent refraction ( SER ) was observed in older children ( -0.21 D vs + 0.87 D ) . Ethnic differences in myopia prevalence are emerging with South Asian children having higher levels than white European children 36.8 % vs 18.6 % ( for the older children ) . Axial length , corneal radius of curvature and anterior chamber depth were normally distributed , while SER was leptokurtic ( p<0.001 ) with a slight negative skew . CONCLUSIONS The AES will allow ethnic differences in the ocular characteristics of children from a large metropolitan area of the UK to be examined . The findings to date indicate the emergence of higher levels of myopia by early adolescence in second and third generation British South Asians , compared to white European children . The continuation of the AES will allow the early determinants of these ethnic differences to be studied PURPOSE To assess the prevalence of refractive errors and vision impairment in school-age children in Shunyi District , northeast of Beijing , the Peoples Republic of China . METHODS R and om selection of village-based clusters was used to identify a sample of children 5 to 15 years of age . Resident registration books were used to enumerate eligible children in the selected villages and identify their current school . Ophthalmic examinations were conducted in 132 schools on children from 29 clusters during May 1988 to July 1998 , including visual acuity measurements , cycloplegic retinoscopy , cycloplegic autorefraction , ocular motility evaluation , and examination of the external eye , anterior segment , media , and fundus . Independent replicate measurements of all children with reduced vision and a sample of those with normal vision were done for quality assurance monitoring in three schools . RESULTS A total of 6,134 children from 4,338 households were enumerated , and 5,884 children ( 95.9 % ) were examined . The prevalence of uncorrected , presenting , and best visual acuity 0.5 ( 20/40 ) or worse in at least one eye was 12.8 % , 10.9 % , and 1.8 % , respectively ; 0.4 % had best visual acuity 0.5 or worse in both eyes . Refractive error was the cause in 89.5 % of the 1,236 eyes with reduced vision , amblyopia in 5 % , other causes in 1.5 % , with unexplained causes in the remaining 4 % . Myopia -0.5 diopter or less in either eye was essentially absent in 5-year-old children , but increased to 36.7 % in males and 55.0 % in females by age 15 . Over this same age range , hyperopia 2 diopters or greater decreased from 8.8 % in males and 19.6 % in females to less than 2 % in both . Females had a significantly higher risk of both myopia and hyperopia . CONCLUSIONS Reduced vision because of myopia is an important public health problem in school-age children in Shunyi District . More than 9 % of children could benefit from prescription glasses . Further studies are needed to determine whether the upward trend in the prevalence of myopia continues far beyond age 15 and whether the development of myopia is changing for more recent birth cohorts purpose To determine the age- and gender-specific prevalences of refractive errors in Tehran through a population -based study . methods A total of 6497 citizens representing a cross-section of the population of Tehran were sample d from 160 clusters using a stratified , r and om , cluster sampling strategy . Eligible people were enumerated through a door-to-door household survey in the selected clusters and were invited to participate . All participants were transferred to a clinic for an extensive eye examination and interview . Refractive error was determined using manifest and cycloplegic refraction . Myopia was defined as the spherical equivalent of −0.5 diopters ( D ) or more and hyperopia was defined as the spherical equivalent of more than + 0.5 D. results Of those sample d , 4565 ( 70.3 % ) people participated in the study . Refraction data for 4354 participants aged five years and over are presented . The age- and gender-st and ardized prevalence of myopia based on manifest refraction was 21.8 % ( 95 % confidence interval [ CI ] , 20.1 to 23.5 ) and that for hyperopia was 26.0 % ( 95 % CI , 24.5 to 27.6 ) . The prevalences based on cycloplegic refraction were 17.2 % ( 95 % CI , 15.6 to 18.8 ) and 56.6 % ( 95 % CI , 54.7 to 58.6 ) , respectively . Prevalences of myopia and hyperopia differed significantly among the age and gender groups ( P < 0.001 ) . Astigmatism of 0.75 cylinder diopter or greater was present in 29.6 % ( 95 % CI , 28.0 to 31.3 ) of right eyes with manifest refraction and in 30.3 % ( 95 % CI , 28.5 to 32.1 ) with cycloplegic refraction . Among the study population , 6.1 % ( 95 % CI , 5.3 to 6.8 % ) had anisometropia of 1 D or more . conclusions This report has provided details of the refractive status in the population . We have documented prevalences of myopia , hyperopia , astigmatism and anisometropia by age and gender , identifying more affected age- and gender-groups for prevention programs in the community Objective : This study investigated the distribution pattern of refractive status and prevalence of refractive errors in school-age children in Western China to determine the possible environmental factors . Methods : A r and om sampling strategy in geographically defined clusters was used to identify children aged 6 - 15 years in Yongchuan , a socio-economically representative area in Western China . We carried out a door-to-door survey and actual eye examinations , including visual acuity measurements , stereopsis examination , anterior segment and eyeball movements , fundus examinations , and cycloplegic retinoscopy with 1 % cyclopentolate . Results : A total of 3469 children living in 2552 households were selected , and 3070 were examined . The distributions of refractive status were positively-skewed for 6 - 8-year-olds , and negatively-skewed for 9 - 12 and 13 - 15-year-olds . The prevalence of hyperopia ( ≥+2.00 D spherical equivalent [ SE ] ) , myopia ( ≤-0.50 D SE ) , and astigmatism ( ≥1.00 diopter of cylinder [ DC ] ) were 3.26 % , 13.75 % , and 3.75 % , respectively . As children 's ages increased , the prevalence rate of hyperopia decreased ( P<0.001 ) and that of myopia increased significantly ( P<0.001 ) . Children in academically challenging schools had a higher risk of myopia ( P<0.001 ) and astigmatism ( ≥1.00DC , P = 0.04 ) than those in regular schools . Conclusion : The distribution of refractive
Output:
| With regard to associated factors , age has an inverse association with hyperopia .
The frequency of hyperopia is higher among White children and those who live in rural areas .
There is no consensus about the association between hyperopia and gender , family income and parental schooling . |
MS213203 | ***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 The objectives of this study were to evaluate the efficacy , safety , and tolerability of quetiapine for treating psychosis in patients with probable/possible Alzheimer disease and assess its impact on other psychopathology and social and daily functioning . METHOD The authors conducted a multicenter , double-blind , placebo-controlled , r and omized trial of flexibly dosed quetiapine and haloperidol . Primary outcomes were change in total Brief Psychiatric Rating Scale ( BPRS ) and Clinical Global Impressions-Severity of Illness ( CGI-S ) scores at week 10 . Secondary outcomes included BPRS factors , Neuropsychiatric Inventory ( NPI ) , Multidimensional Observation Scale for Elderly Subjects ( MOSES ) , and Physical Self-Maintenance Scale ( PSMS ) . RESULTS Two hundred eighty-four participants ( mean age : 83.2 years ) were r and omized ; 63.4 % completed ; and mean Mini-Mental State Examination score was 12.8 . Median of the mean daily dose was 96.9 mg for quetiapine and 1.9 mg for haloperidol . No differential benefit was seen on any psychosis measure . BPRS agitation factor scores improved with quetiapine versus placebo and not quetiapine versus haloperidol . BPRS anergia scores worsened with haloperidol versus quetiapine but not quetiapine versus placebo . No NPI factors showed change , including the agitation factor . MOSES Withdrawal Subscale and PSMS total scores worsened with haloperidol versus quetiapine . Somnolence occurred in 25.3 % , 36.2 % , and 4.1 % of the quetiapine , haloperidol , and placebo groups , respectively ; parkinsonism was most prevalent in the haloperidol group ; other safety and tolerability measures differed little among groups . CONCLUSION All treatment groups showed improvement in measures of psychosis without significant differences between them when planned comparisons were performed . Participants treated with quetiapine or haloperidol showed inconsistent evidence of improvement in agitation . Tolerability was better with quetiapine compared with haloperidol SETTING Treating elderly patients with Alzheimer 's disease ( AD ) and behavioral and psychological symptoms of dementia ( BPSD ) is challenging due to the increased risk of iatrogenic movement disorders with old neuroleptics and the seemingly increasing risk of cardiovascular events with newer atypical agents . Quetiapine is an atypical antipsychotic agent that warrants further investigation . OBJECTIVES To assess tolerability , safety , and clinical benefit of quetiapine in AD patients with BPSD . PARTICIPANTS AND DESIGN AD patients with BPSD participated in a 6-week r and omized , double-blind , placebo-controlled trial . Quetiapine was increased on the basis of clinical response and tolerability . Primary efficacy assessment s included the Neuropsychiatric Inventory ( NPI ) and Clinical Global Impression of Change ( CGI-C ) . Secondary efficacy measures included the Mini-Mental State Examination ( MMSE ) , the Simpson-Angus Scale ( SAS ) and the Abnormal Involuntary Movement Scale ( AIMS ) . RESULTS Forty patients ( 26 women ) , mean age 82.2 ( SD 6.4 ) years were enrolled , 27 completed treatment . Median dose of quetiapine was 200 mg/day . Significant NPI total scores reductions ( 79 % for placebo and 68.5 % for quetiapine ) were observed . The CGI-C score decreased significantly in the quetiapine group ( p = 0.009 at 6 weeks ) and did not change significantly in the placebo group ( p = 0.48 ) . The MMSE , AIMS , SAS scores and adverse events did not differ significantly between the two arms . CONCLUSIONS Quetiapine did not significantly improve psychosis scores . It did not cause cognitive and motor deterioration . These results might possibly be due to small sample size OBJECTIVE To compare citalopram and risperidone for the treatment of psychotic symptoms and agitation associated with dementia , with a priori hypotheses that risperidone would be more efficacious for psychosis and citalopram for agitation . METHODS A 12-week r and omized , controlled trial in nondepressed patients with dementia hospitalized because of behavioral symptoms ( N = 103 ) was conducted at the University of Pittsburgh Medical Center . Participants were consecutively recruited on an inpatient unit if they had at least one moderate to severe target symptom ( aggression , agitation , hostility , suspiciousness , hallucinations , or delusions ) . Once they improved sufficiently , they were discharged to nursing homes , personal care homes , or residential homes for continued treatment . Planned pre-post and mixed model analyses of the main outcome measures of Neurobehavioral Rating Scale and Side Effect Rating Scale at baseline and at weekly/biweekly intervals were conducted . RESULTS Completion rates did not differ for citalopram and risperidone ( overall completion rate : 44 % ) . Agitation symptoms ( aggression , agitation , or hostility ) and psychotic symptoms ( suspiciousness , hallucinations , or delusions ) decreased in both treatment groups but the improvement did not differ significantly between the two groups . There was a significant increase in side effect burden with risperidone but not with citalopram such that the two groups differed significantly . CONCLUSION No statistical difference was found in the efficacy of citalopram and risperidone for the treatment of either agitation or psychotic symptoms in patients with dementia . These findings need to be replicated before citalopram or other serotonergic antidepressants can be recommended as alternatives to antipsychotics for the treatment of agitation or psychotic symptoms associated with dementia Yokukansan ( YKS ) , a traditional herbal medicine , has been used to treat behavioral and psychological symptoms of dementia ( BPSD ) . The present study is the first double‐blind , r and omized , placebo‐controlled trial to determine the efficacy and safety of YKS for the treatment of BPSD in Alzheimer 's disease ( AD ) Background Agitation in Alzheimer ’s disease ( AD ) is common and associated with poor patient life- quality and carer distress . The best evidence -based pharmacological treatments are antipsychotics which have limited benefits with increased morbidity and mortality . There are no memantine trials in clinical ly significant agitation but post-hoc analyses in other population s found reduced agitation . We tested the primary hypothesis , memantine is superior to placebo for clinical ly significant agitation , in patients with moderate-to-severe AD . Methods and Findings We recruited 153 participants with AD and clinical ly significant agitation from care-homes or hospitals for a double-blind r and omised-controlled trial and 149 people started the trial of memantine versus placebo . The primary outcome was 6 weeks mixed model autoregressive analysis of Cohen-Mansfield Agitation Inventory ( CMAI ) . Secondary outcomes were : 12 weeks CMAI ; 6 and 12 weeks Neuropsychiatric symptoms ( NPI ) , Clinical Global Impression Change ( CGI-C ) , St and ardised Mini Mental State Examination , Severe Impairment Battery . Using a mixed effects model we found no significant differences in the primary outcome , 6 weeks CMAI , between memantine and placebo ( memantine lower −3.0 ; −8.3 to 2.2 , p = 0.26 ) ; or 12 weeks CMAI ; or CGI-C or adverse events at 6 or 12 weeks . NPI mean difference favoured memantine at weeks 6 ( −6.9 ; −12.2 to −1.6 ; p = 0.012 ) and 12 ( −9.6 ; −15.0 to −4.3 p = 0.0005 ) . Memantine was significantly better than placebo for cognition . The main study limitation is that it still remains to be determined whether memantine has a role in milder agitation in AD . Conclusions Memantine did not improve significant agitation in people with in moderate-to-severe AD . Future studies are urgently needed to test other pharmacological c and i date s in this group and memantine for neuropsychiatric symptoms . Trial Registration Clinical Trials.gov NCT00371059 Trial Registration International St and ard R and omised Controlled Trial BACKGROUND Second-generation ( atypical ) antipsychotic drugs are widely used to treat psychosis , aggression , and agitation in patients with Alzheimer 's disease , but their benefits are uncertain and concerns about safety have emerged . We assessed the effectiveness of atypical antipsychotic drugs in out patients with Alzheimer 's disease . METHODS In this 42-site , double-blind , placebo-controlled trial , 421 out patients with Alzheimer 's disease and psychosis , aggression , or agitation were r and omly assigned to receive olanzapine ( mean dose , 5.5 mg per day ) , quetiapine ( mean dose , 56.5 mg per day ) , risperidone ( mean dose , 1.0 mg per day ) , or placebo . Doses were adjusted as needed , and patients were followed for up to 36 weeks . The main outcomes were the time from initial treatment to the discontinuation of treatment for any reason and the number of patients with at least minimal improvement on the Clinical Global Impression of Change ( CGIC ) scale at 12 weeks . RESULTS There were no significant differences among treatments with regard to the time to the discontinuation of treatment for any reason : olanzapine ( median , 8.1 weeks ) , quetiapine ( median , 5.3 weeks ) , risperidone ( median , 7.4 weeks ) , and placebo ( median , 8.0 weeks ) ( P=0.52 ) . The median time to the discontinuation of treatment due to a lack of efficacy favored olanzapine ( 22.1 weeks ) and risperidone ( 26.7 weeks ) as compared with quetiapine ( 9.1 weeks ) and placebo ( 9.0 weeks ) ( P=0.002 ) . The time to the discontinuation of treatment due to adverse events or intolerability favored placebo . Overall , 24 % of patients who received olanzapine , 16 % of patients who received quetiapine , 18 % of patients who received risperidone , and 5 % of patients who received placebo discontinued their assigned treatment owing to intolerability ( P=0.009 ) . No significant differences were noted among the groups with regard to improvement on the CGIC scale . Improvement was observed in 32 % of patients assigned to olanzapine , 26 % of patients assigned to quetiapine , 29 % of patients assigned to risperidone , and 21 % of patients assigned to placebo ( P=0.22 ) . CONCLUSIONS Adverse effects offset advantages in the efficacy of atypical antipsychotic drugs for the treatment of psychosis , aggression , or agitation in patients with Alzheimer 's disease . ( Clinical Trials.gov number , NCT00015548 [ Clinical Trials.gov ] . ) CONTEXT Cognitive decline , mood , behavioral and sleep disturbances , and limitations of activities of daily living commonly burden elderly patients with dementia and their caregivers . Circadian rhythm disturbances have been associated with these symptoms . OBJECTIVE To determine whether the progression of cognitive and noncognitive symptoms may be ameliorated by individual or combined long-term application of the 2 major synchronizers of the circadian timing system : bright light and melatonin . DESIGN , SETTING , AND PARTICIPANTS A long-term , double-blind , placebo-controlled , 2 x 2 factorial r and omized trial performed from 1999 to 2004 with 189 residents of 12 group care facilities in the Netherl and s ; mean ( SD ) age , 85.8 ( 5.5 ) years ; 90 % were female and 87 % had dementia . INTERVENTIONS R and om assignment by facility to long-term daily treatment with whole-day bright ( + /- 1000 lux ) or dim ( + /- 300 lux ) light and by participant to evening melatonin ( 2.5 mg ) or placebo for a mean ( SD ) of 15 ( 12 ) months ( maximum period of 3.5 years ) . MAIN OUTCOME MEASURES St and ardized scales for cognitive and noncognitive symptoms , limitations of activities of daily living , and adverse effects assessed every 6 months . RESULTS Light attenuated cognitive deterioration by a mean of 0.9 points ( 95 % confidence interval [ CI ] , 0.04 - 1.71 ) on the Mini-Mental State Examination or a relative 5 % . Light also ameliorated depressive symptoms by 1.5 points ( 95 % CI , 0.24 - 2.70 ) on the Cornell Scale for Depression in Dementia or a relative 19 % , and attenuated the increase in functional limitations over time by 1.8 points per year ( 95 % CI , 0.61 - 2.92 ) on the nurse-informant activities of daily living scale or a relative 53 % difference . Melatonin shortened sleep onset latency by 8.2 minutes ( 95 % CI , 1.08 - 15.38 ) or 19 % and increased sleep duration by 27 minutes ( 95 % CI , 9 - 46 ) or 6 % . However , melatonin adversely affected scores on the Philadelphia Geriatric Centre Affect Rating Scale , both for positive affect ( -0.5 points ; 95 % CI , -0.
Output:
| Haloperidol appeared less efficacious than nearly all comparators .
Most treatments had noninferior treatment continuation compared to placebo , except oxcarbazepine , which was inferior .
CONCLUSIONS Risperidone , serotonin reuptake inhibitors as a class and dextromethorphan/quinidine demonstrated evidence of efficacy for agitation in dementia , although findings for dextromethorphan/quinidine were based on a single RCT .
Our findings do not support prescribing haloperidol due to lack of efficacy , or oxcarbazepine due to lack of acceptability . |
MS213204 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Background Adolescent idiopathic scoliosis ( AIS ) remains the most common deforming orthopedic condition in children . Increasingly , both adults and children are seeking complementary and alternative therapy , including chiropractic treatment , for a wide variety of health concerns . The scientific evidence supporting the use chiropractic intervention is inadequate . The purpose of this study was to conduct a pilot study and explore issues of safety , patient recruitment and compliance , treatment st and ardization , sham treatment refinement , inter-professional cooperation , quality assurance , and outcome measure selection . Methods Six patients participated in this 6-month study , 5 of whom were female . One female was braced . The mean age of these patients was 14 years , and the mean Cobb angle was 22.2 degrees . The study design was a r and omized controlled clinical trial with two independent and blinded observers . Three patients were treated by st and ard medical care ( observation or brace treatment ) , two were treated with st and ard medical care plus chiropractic manipulation , and one was treated with st and ard medical care plus sham manipulation . The primary outcome measure was Cobb , and the psychosocial measure was Scoliosis Quality of Life Index . Results Orthopedic surgeons and chiropractors were easily recruited and worked cooperatively throughout the trial . Patient recruitment and compliance was good . Chiropractic treatments were safely employed , and research protocol s were successful . Conclusion Overall , our pilot study showed the viability for a larger r and omized trial . This pilot confirms the strength of existing protocol s with amendments for use in a full r and omized controlled trial . Trial registration This trial has been assigned an international st and ard r and omized controlled trial number by Current Controlled Trials , Ltd. http://www.controlled-trials.com/is rct n/. The number is IS RCT N41221647 OBJECTIVE To evaluate chiropractic management of primary nocturnal enuresis in children . DESIGN A controlled clinical trial for 10 wk preceded by and followed by a 2-wk nontreatment period . SETTING Chiropractic clinic of the Palmer Institute of Graduate Studies and Research . PARTICIPANTS Forty-six nocturnal enuretic children ( 31 treatment and 15 control group ) , from a group of 57 children initially included in the study , participated in the trial . INTERVENTION High velocity , short lever adjustments of the spine consistent with the Palmer Package Techniques ; or a sham adjustment using an Activator at a nontension setting administered to the examiner 's underlying contact point . Two 5th-year chiropractic students under the supervision of two clinic faculty performed the adjustments . MAIN OUTCOME MEASURES Frequency of wet nights . RESULTS The post-treatment mean wet night frequency of 7.6 nights/2 wk for the treatment group was significantly less than its baseline mean wet night frequency of 9.1 nights/2 wk ( p = 0.05 ) . For the control group , there was practically no change ( 12.1 to 12.2 nights/2 wk ) in the mean wet night frequency from the baseline to the post-treatment . The mean pre- to post-treatment change in the wet night frequency for the treatment group compared with the control group did not reach statistical significance ( p = 0.067 ) . Twenty-five percent of the treatment-group children had 50 % or more reduction in the wet night frequency from baseline to post-treatment while none among the control group had such reduction . CONCLUSIONS Results of the present study strongly suggest the effectiveness of chiropractic treatment for primary nocturnal enuresis . A larger study of longer duration with a 6-month follow-up is therefore warranted OBJECTIVE The purpose of this study was to describe Danish chiropractic patients younger than 18 years . METHODS Question naires were mailed to all chiropractic clinics in Denmark during a r and omly assigned month between September 2007 and September 2008 . All patients younger than 18 years or their parents were asked to complete a question naire collecting information on age , presenting complaint , duration and consequences of this complaint , referral mode , and use of pain medication . RESULTS Babies were the most common pediatric patients with about one third being between 0 and 4 months of age . Infantile colic was the most common presenting complaint in this age group . For the older children , musculoskeletal problems were the most dominant complaint , ranging from 33 % among the preschool children to 75 % among the teenagers . These complaints were often chronic and about a third of the children older than 2 years had experienced symptoms for more than 1 year before seeing the chiropractor . These health complaints were reported to restrict activity as well as alter mood , and 39 % of the 2- to 17-year olds used analgesics . There was limited referral of patients from other health care professionals . CONCLUSIONS Babies made up most of the Danish chiropractic patients younger than 18 years . Among the older children and the adolescents , musculoskeletal complaints were most common and mostly of a chronic nature . The large number of pediatric patients in chiropractic practice s and the paucity of evidence of treatment effectiveness indicate the need for further research in these age groups Objective . To compare supination at the wrist followed by flexion at the elbow ( the traditional reduction technique ) to hyperpronation at the wrist in the reduction of radial head subluxations ( nursemaid 's elbow ) . Material s and Methods . This prospect i ve , r and omized study involved a consecutive sampling of children younger than 6 years of age who presented to one of two urban pediatric emergency departments and two suburban pediatric ambulatory care centers with a clinical diagnosis of radial head subluxation . Patients were r and omized to undergo reduction by one of the two methods and were followed every 5 minutes for return of elbow function . The initial procedure was repeated if baseline functioning did not return 15 minutes after the initial reduction attempt . Failure of that technique 30 minutes after the initial reduction attempt result ed in a cross-over to the alternate method of reduction . The alternate procedure was repeated if baseline functioning did not return 15 minutes after the alternate procedure was attempted . If the patient failed both techniques , radio-graphy of the elbow was performed . Results . A total of 90 patients were enrolled in the study . Five patients were removed from further analysis secondary to a final diagnosis of fracture , 84 were reduced successfully , and 1 failed both techniques . Demographic characteristics of each group were similar . Thirty-nine of 41 patients ( 95 % ) r and omized to hyper-pronation were reduced successfully on the first attempt versus 34 of 44 patients ( 77 % ) r and omized to supination . Two patients in the hyperpronation group required two attempts versus 10 patients in the supination group . Hyperpronation was more successful ; 40 of 41 patients ( 97.5 % ) in the hyperpronation group were reduced successfully versus 38 of 44 patients ( 86 % ) in the supination group . Of the 6 patients who crossed over from supination to hyperpronation , 5 were reduced on the first attempt and 1 was reduced on the second attempt . Conclusions . In the reduction of radial head subluxations , the hyperpronation technique required fewer attempts at reduction compared with supination , was successful more often than supination , and was often successful when supination failed OBJECTIVE To provide a review of the literature and rate the quality of published studies regarding chiropractic care , including spinal manipulation , for asthmatic patients . METHODS A multimodal search strategy was conducted , including multiple data base search es , along with reference and journal h and - search ing . Studies were limited to those published in English and in peer- review ed journals or conference proceedings between January 1980 and March 2009 . All study design s were considered except personal narratives or review s. Retrieved articles that met the inclusion criteria were rated for quality by using the Downs and Black checklist . A brief summary was also written for each retrieved study . RESULTS Eight articles met the inclusion criteria of this review in the form of one case series , one case study , one survey , two r and omized controlled trials ( RCTs ) , one r and omized patient and observer blinded cross-over trial , one single blind cross study design , and one self-reported impairment question naire . Their quality scores ranged from 5 to 22 out of 27 . CONCLUSION Results of the eight retrieved studies indicated that chiropractic care showed improvements in subjective measures and , to a lesser degree objective measures , none of which were statistically significant . It is evident that some asthmatic patients may benefit from this treatment approach ; however , at this time , the evidence suggests chiropractic care should be used as an adjunct , not a replacement , to traditional medical therapy OBJECTIVE This study investigates the effect of chiropractic treatment on hip joint extension ability and running velocity . METHODS This was a prospect i ve , r and omized , controlled experimental pilot study . Seventeen healthy male junior athletes ( age , 17 - 20 years ) training in middle distance running were recruited from local Swedish athletic associations . Hip extension ability and running velocity were measured before and after the study period . Chiropractic investigations comprised motion palpation of the sacroiliac and hip joints and modified Thomas test of the ability to extend the leg . In the treatment group , findings of restrictive joint dysfunctions formed the basis for the choice of chiropractic treatment . The interventions were based on a pragmatic approach consisting of high-velocity , low-amplitude manipulations targeted toward , but not exclusively to , the sacroiliac joints . RESULTS The treatment group showed significantly greater hip extension ability after chiropractic treatment than did controls ( P < .05 ) . Participants in the treatment group did not show a significant decrease in time for running 30 m after treatment ( average , -0.065 seconds ; P = .0572 ) , whereas the difference was even smaller for the control subjects ( average , -0.003 ; P = .7344 ) . CONCLUSIONS The results imply that chiropractic treatment can improve hip extensibility in subjects with restriction as measured by the modified Thomas test . It could be speculated that the running step was amplified by increasing the angle of step through facilitated hip joint extension ability . The possible effect of chiropractic treatment to enhance the running velocity , by increasing the hip joint extension ability and thereby increasing the running step , remains unproven A prospect i ve , uncontrolled study of 316 infants suffering from infantile colic and selected according to well-defined criteria shows a satisfactory result of spinal manipulative therapy in 94 % of the cases . The median age of the infants was 5.7 wk at the beginning of the treatment . The results were evaluated by analysis of a diary continuously kept by the mother and an assessment file comprised by interview . The study was carried out as a multicenter study lasting 3 months and involving 73 chiropractors in 50 clinics . The results occurred within 2 wk and after an average of three treatments OBJECTIVE To review the biomedical literature up to and including 2003 , and determine the extent of the evidence related to the therapeutic application of chiropractic manipulation for paediatric health conditions . No critical appraisal of the evidence is undertaken . DATA SOURCES The indexed manual therapy sector including medical , chiropractic , physiotherapy , naturopathic and osteopathic literature was search ed . This included PubMed ; the Manual , Alternative , and Natural Therapy Index System ; the Cumulative Index to Nursing and Allied Health Literature ; the Index to Chiropractic Literature ; the Paediatric Economic Data base Evaluation Project ; the Cochrane Library ; the Canadian Coordinating Office for Health Technology Assessment data base ; and the Agency for Healthcare Research and Quality data base . Other re sources included research conference and symposium proceedings , and the references of identified studies . RESULT The search identified 1731 articles , of which 166 met the eligibility criteria . Two review ers determined by consensus each citation 's appropriate level on the strength of evidence scale . There was one systematic review , nine r and omized controlled trials , one observational study , 141 descriptive case studies and 14 conference abstract s. SUMMARY Health cl aims made by practitioners regarding the application of chiropractic manipulation as a health care intervention for paediatric health conditions are , for the most part , supported by low levels of scientific evidence . Chiropractors , in particular , employ manipulation for the treatment of a wide variety of paediatric health conditions . The evidence rests primarily with clinical experience , descriptive case studies and a few r and omized controlled trials . There is a need for more rigorous scientific inquiry to examine the value of manipulative therapy in the treatment of paediatric conditions . To advance the health interests of paediatric patients , health care decisions made on the basis of expert opinion or clinical experience must integrate the best research evidence available from high- quality , scientific studies Background The purpose of this report is to provide a succinct but comprehensive summary of the scientific evidence regarding the effectiveness of manual treatment for the management of a variety of musculoskeletal and non-musculoskeletal conditions . Methods The conclusions are based on the results of systematic review s of r and omized clinical trials ( RCTs ) , widely accepted and primarily UK and United States evidence -based clinical guidelines , plus the results of all RCTs not yet included in the first three categories . The strength/ quality of the evidence regarding effectiveness was based on an adapted version of the grading system developed by the US Preventive Services Task Force and a study risk of bias assessment tool for the recent RCTs . Results By September 2009 , 26 categories of conditions were located containing RCT evidence for the use of manual therapy : 13 musculoskeletal conditions , four types of chronic headache and nine non-musculoskeletal conditions . We identified 49 recent relevant systematic review s and 16 evidence -based clinical guidelines plus an additional 46 RCTs not yet included in systematic review s and guidelines .Additionally , brief references are made to other effective non-pharmacological , non-invasive physical treatments . Conclusions Spinal manipulation/mobilization is effective in adults for : acute
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| CONCLUSION Studies that monitored both subjective and objective outcome measures of relevance to both patients and parents tended to report the most favorable response to SMT , especially among children with asthma . |
MS213205 | ***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: Cigarette smoking is a risk factor for colorectal adenoma , a precursor of colorectal cancer . Microsomal epoxide hydrolase ( EPHX1 ) metabolizes polycyclic aromatic hydrocarbons , carcinogens found in cigarette smoke . Nonsynonymous variants of EPHX1 at Tyr(113)His ( exon 3 ) and His(139)Arg ( exon 4 ) are associated , respectively , with low ( (113)His ) and high ( (139)Arg ) predicted activity . Among participants r and omized to the screening arm of the Prostate , Lung , Colorectal , and Ovarian Cancer Screening Trial , we evaluated risks for advanced adenoma in relation to cigarette use and these two EPHX1 variants . We compared 772 cases with advanced adenoma ( adenoma > /=1 cm or containing high- grade dysplasia or villous , including tubulovillous , elements ) of the distal colon ( left-sided , descending colon and sigmoid or rectum ) to 777 gender- and age-matched controls who were screen-negative for left-sided adenoma . Compared to those with homozygous genotypes predicting low EPHX1 activity , advanced adenoma risks tended to be elevated for carriers of (113)TyrTyr [ odds ratios ( OR ) , 1.5 ; 95 % confidence intervals ( CI ) , 1.0 - 2.2 ] and (139)ArgArg ( OR , 1.4 ; 95 % CI , 0.8 - 2.5 ) and for subjects who carried a greater number of the alleles ( (113)Tyr or (139)Arg ) associated with high predicted enzymatic activity ( P(trend ) = 0.03 ) . The increased risk associated with the increasing number of putative high-activity alleles was most apparent among current and recent ( quit < 10 years ) cigarette smokers ( P(trend ) = 0.02 ) . In conclusion , EPHX1 variants at codon 113 and 139 associated with high predicted enzymatic activity appear to increase risk for colorectal adenoma , particularly among recent and current smokers Microsomal epoxide hydrolase ( mEH ) is involved in the metabolism of environmental and tobacco carcinogens . Smaller studies found inconsistent results in the relationship between mEH polymorphisms and lung cancer risk . We investigated the two polymorphisms of mEH in 974 Caucasian lung cancer patients and 1142 controls using PCR-RFLP techniques . The results were analyzed using generalized additive models and logistic regression , adjusting for relevant covariates . There was no overall relationship between mEH genotypes and lung cancer risk . The adjusted odds ratio ( OR ) of the very low activity genotype versus that of other genotypes combined was 1.00 [ 95 % confidence interval ( CI ) , 0.74 - 1.34 ] . However , gene-environment interaction analyses revealed that the ORs decreased as cumulative smoking ( defined as square root of pack-years ) increased . When pack-years = 0 , the OR was 1.89 ( 95 % CI , 1.08 - 3.28 ) . When pack-years = 28.5 , the OR was 1.00 ( 95 % CI , 0.76 - 1.32 ) , and when pack-years = 80 , the OR decreased to 0.65 ( 95 % CI , 0.42 - 1.00 ) . When cases were stratified according to histological subtypes , the interaction between mEH genotype and cumulative smoking was statistically significant ( P < 0.01 ) for the 222 squamous cell carcinoma cases , whereas it was not significant ( P = 0.18 ) for the 432 adenocarcinoma cases . In conclusion , cumulative cigarette smoking plays a pivotal role in the association between mEH polymorphisms and lung cancer risk , altering the direction of risk ( in the case of the very low activity genotype ) from a risk factor in nonsmokers to a relatively protective factor in heavy smokers
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| / SIGNIFICANCE Putative low EPHX1 enzyme activity may have a potential protective effect on tobacco-related carcinogenesis of lung and UADT cancers , whereas putative high EPHX1 activity may have a harmful effect .
Moreover , cigarette-smoking status may influence the association of EPHX1 enzyme activity and the related cancer risk |
MS213206 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Child development literature suggests a relationship between mother-child interaction and enhanced infant development . We conducted a r and omized clinical trial to determine if a pediatrician 's guidance improves the mother-infant relationship and the infant 's development . Thirty-two normal mothers and their healthy first-born infants were followed by one pediatrician at 2 , 4 , 8 , 15 , and 21 weeks of age . These dyads were r and omly assigned to a control group , who received customary care , or to an intervention group , who also received guidance based on the infant 's developmental status at each age . Just prior to a 27-week visit , the mother-infant relationship was assessed by a person blind to group assignment . Infant development was assessed with the Bayley Mental Scales of Infant Development and two of the Uzguris-Hunt Ordinal Scales . Intervention group mothers were rated significantly higher on sensitivity , cooperation , appropriateness of interaction , and appropriateness of play ( P less than .05 ) . Experimental infants were advanced on the Vocal Imitation ordinal scale . This study shows the effectiveness of this intervention on both the mother-infant relationship and infant development and supports pediatric involvement in this biosocial approach to well child care OBJECTIVES We evaluated Legacy for Children , a public health strategy to improve child health and development among low-income families . METHODS Mothers were recruited prenatally or at the birth of a child to participate in Legacy parenting groups for 3 to 5 years . A set of 2 r and omized trials in Miami , Florida , and Los Angeles , California , between 2001 and 2009 assessed 574 mother-child pairs when the children were 6 , 12 , 24 , 36 , 48 , and 60 months old . Intent-to-treat analyses from 12 to 60 months compared groups on child behavioral and socioemotional outcomes . RESULTS Children of mothers in the intervention group were at lower risk for behavioral concerns at 24 months and socioemotional problems at 48 months in Miami , and lower risk for hyperactive behavior at 60 months in Los Angeles . Longitudinal analyses indicated that children of intervention mothers in Miami were at lower risk for behavior problems from 24 to 60 months of age . CONCLUSIONS R and omized controlled trials documented effectiveness of the Legacy model over time while allowing for implementation adaptations by 2 different sites . Broadly disseminable , parent-focused prevention models such as Legacy have potential for public health impact . These investments in prevention might reduce the need for later intervention strategies Background For the first time to our knowledge , short- and long-term effects of a multi-site r and omized-controlled trial ( RCT ) of video feedback of infant – parent interaction ( VIPI ) intervention in naturalistic setting s are published . The intervention targets families with children younger than 2 years old and parent – child interactions problems . Outcome variables were 1 ) observed parent – child interactions and 2 ) parent-reported child social and emotional development . Between-group differences of the moderating effects of parental symptoms of depression , personality disorders traits , and demographic variables were investigated . Method The study had a parallel-group , consecutively r and omized , single-blinded design ; participants were recruited by health- and social workers . Seventy-five families received VIPI , and 57 families received treatment as usual ( TAU ) . Videotapes of each parent – child interactions were obtained before treatment , right after treatment , and at a 6-month follow-up and coded according to Biringen ’s Emotional Availability Scales . Parental symptoms of depression and personality disorder traits were included as possible moderators . Results Evidence of a short-term effect of VIPI treatment on parent – child interactions was established , especially among depressed parents and parents with problematic interactions– and , to some extent , among parents with dependent and paranoid personality disorder traits . A long-term positive effect of VIPI compared with TAU on child social/emotional development was also evident . In a secondary analysis , VIPI had a direct positive effect on the depressive symptoms of parents compared with TAU . Conclusion The findings of the study support the use of VIPI as an intervention in families with interaction difficulties . Trial registration Current Controlled Trials IS RCT N99793905 Based on the US Nurse-Family Partnership ( NFP ) program , the German home visiting program “ Pro Kind ” offered support for socially and financially disadvantaged first-time mothers from pregnancy until the children ’s second birthday . A multi-centered , longitudinal r and omized controlled trial ( RCT ) was conducted to assess its effectiveness on mothers and children . A total of 755 women with multiple risk factors were recruited , 394 received regular home visits ( treatment group ) , while 361 only had access to st and ard community services ( control group ) . Program influences on family environment ( e.g. , quality of home , social support ) , maternal competencies ( e.g. , maternal self-efficacy , empathy , parenting style ) , and child development ( e.g. , cognitive and motor development ) were assessed from mothers ’ program intake in pregnancy to children ’s second birthday based on self-reports in regular interviews and developmental tests . Generalized estimating equations ( GEE ) models showed small , but significant positive treatment effects on parental self-efficacy , and marginally significant effects on social support , and knowledge on child rearing . Maternal stress , self-efficacy , and feelings of attachment in the TG tend to show a more positive development over time . Subgroup effects were found for high-risk mothers in the TG , who reported more social support over time and , generally , had children with higher developmental scores compared to their CG counterparts . Post hoc analyses of implementation variables revealed the quality of the helping relationship as a significant indicator of treatment effects . Results are discussed in terms of implementation and public policy differences between NFP and Pro Kind Objective . To evaluate the extent to which a program of home visitation ( Early Start ) , targeted at families who are facing stress and difficulty , had beneficial consequences for child health , preschool education , service utilization , parenting , child abuse and neglect , and behavioral adjustment . Methods . The study used a r and omized , controlled trial design in which 220 families who were participating in the Early Start program were contrasted with a control series of 223 families who were not participating in the program . Families were enrolled in the program after population screening that was conducted by community health nurses . Families were enrolled in the program for up to 36 months . Outcomes were assessed at 6 , 12 , 24 , and 36 months after trial entry . Results . Families in the Early Start series received a mean of 24 months of service . Comparisons between the Early Start and control series over the 36-month follow-up period revealed that families in the Early Start program showed significant benefits in the areas of improved utilization of child health services , reduced rates of hospital attendance for injury/poisoning , increased preschool education , increased positive and nonpunitive parenting , reduced rates of severe parent/child assaults , and reduced rates of early problem behaviors . Effect sizes ( Cohen 's “ d ” ) were found to be in the small to moderate range , with d ranging from .03 to .31 ( median : .22 ) . Conclusions . The Early Start program was associated with small to moderate benefits in a wide range of areas relating to child health , preschool education , parenting , child abuse , and early behavioral adjustment . Comparisons with other studies are made , and threats to validity are considered Background Psychopathology in women after childbirth represents a significant risk factor for parenting and infant mental health . Regarding child development , these infants are at increased risk for developing unfavorable attachment strategies to their mothers and for subsequent behavioral , emotional and cognitive impairments throughout childhood . To date , the specific efficacy of an early attachment-based parenting group intervention under st and ard clinical outpatient conditions , and the moderators and mediators that promote attachment security in infants of mentally ill mothers , have been poorly evaluated . Methods / Design This r and omized controlled clinical trial tests whether promoting attachment security in infancy with the Circle of Security ( COS ) Intervention will result in a higher rate of securely attached children compared to treatment as usual ( TAU ) . Furthermore , we will determine whether the distributions of securely attached children are moderated or mediated by variations in maternal sensitivity , mentalizing , attachment representations , and psychopathology obtained at baseline and at follow-up . We plan to recruit 80 mother-infant dyads when infants are aged 4 - 9 months with 40 dyads being r and omized to each treatment arm . Infants and mothers will be reassessed when the children are 16 - 18 months of age . Method ological aspects of the study are systematic recruitment and r and omization , explicit inclusion and exclusion criteria , research assessors and coders blinded to treatment allocation , advanced statistical analysis , manualized treatment protocol s and assessment s of treatment adherence and integrity . Discussion The aim of this clinical trial is to determine whether there are specific effects of an attachment-based intervention that promotes attachment security in infants . Additionally , we anticipate being able to utilize data on maternal and child outcome measures to obtain preliminary indications about potential moderators of the intervention and inform hypotheses about which intervention may be most suitable when offered in a clinical psychiatric outpatient context .Trial registration Current Controlled Trials IS RCT The Parents as Teachers ( PAT ) program is a parent-education program that includes home visiting and is design ed to begin prenatally or at birth . Through home visits , visitors called parent educators help parents to strengthen their parenting skills and knowledge of child development and to prepare young children for school . This article describes the PAT program and reports the results of evaluations of two r and omized trials of PAT : ( 1 ) the Northern California ( Salinas Valley ) Parents as Teachers Demonstration , which served primarily Latino parents in the Salinas Valley of California 's Monterey County ; and ( 2 ) the Teen Parents as Teachers Demonstration , which served adolescent parents in four counties in Southern California . The two evaluations revealed small and inconsistent positive effects on parent knowledge , attitudes , and behavior , and no gains in child development or health , when analyses compared the experimental and control groups overall . However , subgroup analyses in the Salinas Valley program indicated that children in primarily Spanish-speaking Latino families benefitted more than either non-Latino or English-speaking Latino families , with significant gains in cognitive , communication , social , and self-help development . Subgroup analyses in the Teen PAT Demonstration indicated that families that received both PAT services and comprehensive case management services design ed to help mothers improve their life course benefitted most . Subgroup analyses in the Salinas Valley study suggested that children in families that received more intensive services benefitted more than children whose families received less intensive services . Results from that study suggested that home visits produced about a one-month developmental advantage per 10 visits for participating children OBJECTIVE : To evaluate the extent to which a home-visitation program ( Early Start ) had benefits for child abuse , child behavior , and parental- and family-level benefits to the 9-year follow-up . METHODS : A r and omized controlled trial in which 220 families receiving Early Start were contrasted with a control series of 223 families not receiving the program . Families were enrolled in the program for up to 5 years . Outcomes were assessed at 6 months , annually from 1 year to 6 years , and at 9 years after trial entry . RESULTS : Comparisons between the Early Start and control series showed that families in the Early Start program showed significant ( P < .05 ) benefits in reduced risk of hospital attendance for unintentional injury , lower risk of parent-reported harsh punishment , lower levels of physical punishment , higher parenting competence scores , and more positive child behavioral adjustment scores . Effect sizes ( Cohen ’s “ d ” ) ranged from 0.13 to 0.29 ( median = 0.25 ) . There were no significant differences ( all P values > .05 ) between the Early Start and control series on a range of measures of parental behavior and family outcomes , including maternal depression , parental substance use , intimate partner violence , adverse economic outcomes , and life stress . CONCLUSIONS : The Early Start program was associated with small to moderate benefits in a range of areas relating to child abuse , physical punishment , child behavior , and parenting competence . There was little evidence to suggest that the Early Start program had benefits that extended to the level of parents or family overall Objectives From a developmental perspective , infancy is a critical stage of life . Early childhood interventions aim to support caretakers , but the effects of universal interventions for parents with infants are unknown . The objective is to determine the effects of universal parenting interventions offered to parents with infants 0–12 months on measures of child development and parent – child relationship . Design A systematic review using the Preferred Reporting Items for Systematic Review s and Meta- Analysis . We extracted publications from 10 data bases in June 2013 , January 2015 and June 2016 and supplemented with grey and h and search . Risk of bias was assessed , and effect sizes were calculated . Participants Inclusion criteria are : ( 1 ) r and omised controlled trials of structured , psychosocial interventions offered to a universal population of parents with infants 0–12 months old in western OECD countries , ( 2 ) interventions that include a minimum of 3 sessions with at least half of the sessions delivered postnatally and ( 3 ) programme outcomes reported for child development or parent – child relationship . Results 14 papers representing 7 studies are included . There were no statistically significant effects of the intervention for the majority of the primary outcomes across the studies . Conclusions The findings of this review are mixed . No clear conclusions can be drawn regarding the effects of universally offered parenting interventions on child development and parent – child relationship for this age group BACKGROUND The Copenhagen Child Cohort , CCC 2000 , was established to investigate developmental psychopathology prospect ively from birth in a general population . METHODS A r and om sample of 211 children from the CCC 2000 was investigated when the children were 1(1/2 ) years of age . The prevalence and associates of mental health problems and psychopath
Output:
| CONCLUSIONS Interventions offered to at-risk families in the first year of the child 's life appear to improve child behaviour , parent-child relationship and maternal sensitivity post-intervention , but not child cognitive development and internalising or externalising behaviour . |
MS213207 | ***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 This study compares four chemotherapeutic regimens used for inhibiting carious lesion progression : silver nitrate ( AgNO3 ) ; silver fluoride/stannous fluoride ( AgF/SnF2 ) ; silver diammine fluoride ( SDF ) ; and chlorhexidine ( CHX ) . METHODS For this study , a bacterial model system containing Mutans streptococci ( MS ) and Lactobacilli casei ( L ) was used to generate carious lesions on 85 extracted sound permanent third molars which were r and omly assigned to four test groups and one control group . At week two , the four treatment regimens were applied to the lesions ( one treatment per test group ) . RESULTS Six weeks later , lesions treated with a single AgF/SnF2 or AgNO3 application demonstrated 29 % and 19 % less lesion progression , respectively , than did the control group ( P < 0.05 ) . SDF and CHX did not differ significantly from the control . CONCLUSION AgF/SnF2 and AgNO3 may be useful in slowing down carious lesion depth progression The recording of multiple interval-censored failure times is common in dental research . Modeling multilevel data has been a difficult task . This paper aims to use the Bayesian approach to analyze a set of multilevel clustered interval-censored data from a clinical study to investigate the effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting active dentin caries in Chinese pre-school children . The time to arrest dentin caries on a surface was measured . A three-level r and om-effects Weibull regression model was used . Analysis was performed with WinBUGS . Results revealed a strong positive correlation ( 0.596 ) among the caries lesions ’ arrest times on different surfaces from the same child . The software WinBUGS made the above complicated estimation simple . In conclusion , the annual application of silver diamine fluoride on caries lesions , and caries removal before the application , were found to shorten the arrest time We hypothesized that the six-monthly application of silver diamine fluoride ( SDF ) can arrest the development of caries in the deciduous dentition of six-year-old schoolchildren and prevent caries in their first permanent molars . A prospect i ve controlled clinical trial was conducted on the efficacy of a 38 % SDF solution for caries reduction . Four hundred and twenty-five six-year-old children were divided into two groups : One group received SDF solution in primary canines and molars and first permanent molars every 6 mos for 36 mos . The second group served as controls . The 36-month follow-up was completed by 373 children . The mean number of new decayed surfaces appearing in primary teeth during the study was 0.29 in the SDF group vs. 1.43 in controls . The mean of new decayed surfaces in first permanent molars was 0.37 in the SDF group vs. 1.06 in controls . The SDF solution was found to be effective for caries reduction in primary teeth and first permanent molars in schoolchildren Over a period of 18 months the following non-traumatic methods of treating dental caries in deciduous teeth were compared : application of stannous fluoride ( SnF2 ) ; application of SnF2 and silver diamine fluoride ( SDF ) ; application of SnF2 , SDF , minimal cavity preparation and use of composite resin ; minimal cavity preparation and composite resin only ; no treatment . Caries progressed in only 5 per cent of the SDF/SnF2 group and 11 per cent of the composite resin group . The results indicate that it may be possible to treat carious lesions in a non-traumatic way using minimally prepared cavities and composite resin . This could significantly alter the restorative care of deciduous molars and it may be reasonable to speculate that the technique could also have important implication s for use in the permanent dentition This study aim ed to evaluate the risk-benefit balance of several fluoride exposures . Fluoride exposure history of r and omly selected children was collected for calculation of exposure to fluori date d water , toothpaste , and other fluoride sources . We evaluated the risk-benefit balance of fluoride exposure by comparing dental fluorosis on maxillary central incisors , recorded at the time of the study with the use of the Thylstrup and Fejerskov Index , and deciduous caries experience , recorded at age six years , of the same group of South Australian children who were from 8 to 13 years old in 2002–03 . Population Attributable Risk for fluorosis and Population Prevented Fraction for caries were estimated . Fluorosis prevalence was found to be 11.3 % ; caries prevalence , 32.3 % ; mean dmfs , 1.57 ( SD 3.3 ) . Exposure to fluori date d water was positively associated with fluorosis , but was negatively associated with caries . Using 1000-ppm-F toothpaste ( compared with 400- to 550-ppm-F toothpaste ) and eating/licking toothpaste were associated with higher risk of fluorosis without additional benefit in caries protection . Evaluation of the risk-benefit balance of fluoride exposure provides evidence to assist in the formulation of appropriate guidelines for fluoride use Dental caries in Chinese pre-school children is common , and restorative treatment is not readily available . This prospect i ve controlled clinical trial investigated the effectiveness of topical fluoride applications in arresting dentin caries . We divided 375 children ( aged 3 - 5 yrs ) with carious upper anterior teeth into five groups . Children in the first and second groups received annual applications of silver diamine fluoride solution ( 44,800 ppm F ) . NaF varnish ( 22,600 ppm F ) was applied every three months onto the lesions of children in the third and fourth groups . For children in the first and third groups , soft carious tissues were removed prior to fluoride application . The fifth group was the control . We followed 341 children for 18 months . The mean numbers of new caries surfaces in the five groups were 0.4 , 0.4 , 0.8 , 0.6 , and 1.2 , respectively ( p = 0.001 ) . The respective mean numbers of arrested carious tooth surfaces were 2.8 , 3.0 , 1.7 , 1.5 , and 1.0 ( p < 0.001 )
Output:
| These promising results suggest that SDF is more effective than fluoride varnish , and may be a valuable caries-preventive intervention .
As well , the availability of a safe , effective , efficient , and equitable caries-preventive agent appears to meet the criteria of both the WHO Millennium Goals and the US Institute of Medicine ’s criteria for 21st century medical care |
MS213208 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: BACKGROUND Intermittent oral or intravenous doses of calcitriol given two or three times per week are commonly used to treat secondary hyperparathyroidism ( secondary HPT ) . This study was undertaken to compare the biochemical and skeletal responses to thrice weekly intraperitoneal ( i.p . ) versus oral doses of calcitriol in children with secondary HPT undergoing peritoneal dialysis ( CCPD ) . METHODS Forty-six patients aged 12.5+/-4.8 years on CCPD for 22+/-25 months were r and omly assigned to treatment with oral ( p.o . ) or i.p . calcitriol for 12 months ; 17 subjects given p.o . calcitriol and 16 subjects given i.p . calcitriol completed the study . Bone biopsies were performed at the beginning and at the end of the study , while determinations of serum and total ionized calcium , phosphorus , alkaline phosphatase , parathyroid hormone ( PTH ) and calcitriol levels were done monthly . RESULTS Serum total and ionized calcium levels were higher in subjects treated with i.p . calcitriol , P < 0.0001 , whereas serum phosphorus levels were higher in those given p.o . calcitriol , P < 0.0001 . For the i.p . group , serum PTH levels decreased from pre-treatment values of 648+/-125 pg/ml to a nadir of 169+/-57 pg/ml after nine months . In contrast , serum PTH levels did not change from baseline values of 670+/-97 pg/ml in subjects given p.o . calcitriol , P < 0.0001 by multiple regression analysis . Serum alkaline phosphatase levels were also lower in patients treated with i.p . calcitriol , P < 0.0001 , but there was no difference between groups in the average dose of calcitriol given thrice weekly . The skeletal lesions of secondary HPT improved in both groups , 33 % of patients developed adynamic bone lesion . CONCLUSION Differences in the bioavailability of calcitriol and /or in phosphorus metabolism may account for the divergent biochemical response to p.o . and i.p . calcitriol BACKGROUND Oral and intravenous calcitriol bolus therapy are both recommended for the treatment of secondary hyperparathyroidism , but it has been cl aim ed that the latter is less likely to induce absorptive hypercalcemia . The present study was undertaken to verify whether intravenous calcitriol actually stimulates intestinal calcium absorption less than oral calcitriol and whether it is superior in suppressing parathyroid hormone ( PTH ) secretion . METHODS Twenty children ( 16 males , age range of 5.1 to 16.9 years , mean creatinine clearance 21.9 + /- 11.5 mL/min/1.73 m2 , range of 7.4 to 52.7 ) with chronic renal failure ( CRF ) and secondary hyperparathyroidism [ median intact PTH ( iPTH ) , 327 pg/mL ; range 143 to 1323 ] received two single calcitriol boli ( 1.5 mg/m2 body surface area ) orally and intravenously using a r and omized crossover design . iPTH and 1,25(OH)2D3 levels were measured over 72 hours , and intestinal calcium absorption was measured 24 hours after the calcitriol bolus using stable strontium ( Sr ) as a surrogate marker . Baseline control values for Sr absorption were obtained in a separate group of children with CRF of similar severity . RESULTS The peak serum level of 1,25(OH)2D3 and area under the curve baseline to 72 hours ( AUC0 - 72h ) were significantly higher after intravenous ( IV ) calcitriol ( AUC0 - 72h oral , 1399 + /- 979 pg/mL. hour vs. IV 2793 + /- 1102 pg/mL. hour , P < 0.01 ) , but the mean intestinal Sr absorption was not different [ SrAUC0 - 240min during the 4 hours after Sr administration 2867 + /- 1101 FAD% ( fraction of the absorbed dose ) vs. 3117 + /- 1581 FAD% with oral and IV calcitriol , respectively ] . The calcitriol-stimulated Sr absorption was more then 30 % higher compared with control values ( 2165 + /- 176 FAD% ) . A significant decrease in plasma iPTH was noted 12 hours after the administration of the calcitriol bolus , which was maintained for up to 72 hours without any differences regarding the two routes of administration . CONCLUSIONS These results demonstrate that under acute conditions , intravenous and oral calcitriol boli equally stimulate calcium absorption and had a similar efficacy in suppressing PTH secretion Secondary hyperparathyroidism was suppressed over a period of one year in 12 children with chronic renal failure by using a regimen of mild dietary phosphate restriction and high dose phosphate binders . The patients were r and omised to receive either aluminium hydroxide or calcium carbonate by mouth for six months and then crossed over to the other medication . Vitamin D ( dihydrotachysterol ) dosage was unchanged . Serum parathyroid hormone concentrations were reduced to within the normal range , urinary cyclic adenosine monophosphate values fell , plasma phosphate concentrations decreased , and the theoretical renal phosphate threshold increased significantly . Transiliac bone biopsy findings improved in four patients with adequate suppression of parathyroid hormone concentrations , deteriorated in two patients who were not compliant , and did not change in five patients in whom initial bone disease was mild . Growth velocity improved significantly . There was no difference in the clinical response , biochemical changes , or incidence of complications during treatment with the two agents . In view of the risk of aluminium toxicity the use of high dose calcium carbonate with dietary phosphate restriction and vitamin D supplementation is recommended in the control of secondary hyperparathyroidism in children with chronic renal failure Recent studies in adults have suggested that parenteral 1,25-dihydroxyvitamin D3 ( 1,25[OH]2D3 ) may have advantages over oral therapy in the management of renal osteodystrophy . The purpose of this study was to determine whether there were clear differences between oral and IP 1,25(OH)2D3 treatments in children who did not pose a treatment problem . Seven children ( 5 males , 2 females , aged 1.8 to 16 years , median 4.8 years ) undergoing peritoneal dialysis were initially treated with oral 1,25(OH)2D3 for a one month equilibration period They were r and omly assigned to 3 months of either oral or intraperitoneal ( IP ) therapy with 1,25(OH)2D3 followed by 3-months-treatment using the alternative route . No significant differences in serum creatinine , phosphate , or parathyroid hormone concentrations were found between the different routes of administration in the patients . No significant differences in height st and ard deviation scores or renal osteodystrophy scores were found over the six-month study . Paired oral and IP pharmacokinetic studies were performed on these 7 patients and 2 other children who had been treated for at least 2 months using either oral or IP 1,25(OH)2D3 . Serum was taken prior to one of the usual 1,25(OH)2D3 doses and 0.5 , 1.5 , 3 , 6 , and 24 h afterward . The highest measured concentrations of 1,25(OH)2D3 were found at 1.5 h for both oral and IP treatments ( mean Cmax [ SD ] : oral 116 [ 23 ] pmol/l , IP 121 [ 24 ] pmol/l , p > 0.05 ) . The AUC 's for oral and IP therapy were similar ( 1701 [ 276 ] and 1645 [ 301 ] pmol/h/l , respectively ) . In the paired pharmacokinetic studies no significant differences were found between oral and IP treatments for the serum half life ( 27.4 [ 11.6 ] h and 19.2 [ 8.1 ] h , respectively ) and total body clearance ( 15.3 [ 2.1 ] h and 18.4 [ 3.3 ] h , respectively ) of 1,25(OH)2D3 . In children who respond appropriately to oral 1,25(OH)2D3 there is no biological advantage to the use of IP 1,25(OH)2D3 ABSTRACT . Ten children with end stage renal disease on chronic hemofiltration ( HF ) were studied for a 1-yr period to evaluate the efficacy of l,25-dihydroxyvitamin-D3 ( 1,25(OH)2D3 ) therapy on biohumoral parameters of renal osteodystrophy and bone mineral content . In six of these children an acute study was done of the direct effect of the HF procedure on calcium and phosphate balance during 12 HF sessions . During the first 6 months of the study all children were treated with 1,25(OH)2D3 ( 0.25 - 0.50 µg/day ) to maintain plasma calcium at 9.5 - 11.0 mg/dl . There was a significant increase in plasma calcium ( p<0.05 ) and a significant decrease in plasma phosphate ( p<0.01 ) and alkaline phosphatase concentrations ( p<0.05 ) . The circulating levels of NH2 immunoreactive parathyroid hormone did not change , remaining at the upper limits of reference values . Immunoreactive parathyroid hormone- COOH terminal fragment levels decreased significantly ( p<0.05 ) . Bone mineral content rose significantly ( p<0.01 ) . During the last 6 months of the study , to evaluate the possibility that HF alone might control secondary hyperparathyroidism , 1,25(OH)2D3 treatment was discontinued in five children ; plasma calcium and phosphate were well controlled whereas hyperparathyroidism worsened in all five , and one also developed intense pruritus and hypertension . The other five children remained on 1,25(OH)2D3 treatment ; two of these were transplanted , and the other three continued to show an improvement of mineral balance . The results of the acute study showed that calcium balance was positive with a mean Ca++ gain of 140 mg/HF session . The mean total phosphate removed per HF run was 574 mg . We conclude that even though a calcium gain and a high phosphate removal was obtained with our HF prescription , secondary hyperparathyroidism in children on chronic HF may be maintainued under control if 1,25(OH)2D3 supplementation is provided Little is known about the impact of various phosphate binders on the skeletal lesions of secondary hyperparathyroidism ( 2 degrees HPT ) . The effects of calcium carbonate ( CaCO3 ) and sevelamer were compared in pediatric peritoneal dialysis patients with bone biopsy-proven 2 degrees HPT . Twenty-nine patients were r and omly assigned to CaCO3 ( n = 14 ) or sevelamer ( n = 15 ) , concomitant with either intermittent doses of oral calcitriol or doxercalciferol for 8 mo , when bone biopsies were repeated . Serum phosphorus , calcium , parathyroid hormone ( PTH ) , and alkaline phosphatase were measured monthly . The skeletal lesions of 2 degrees HPT improved with both binders , and bone formation rates reached the normal range in approximately 75 % of the patients . Overall , serum phosphorus levels were 5.5 + /- 0.1 and 5.6 + /- 0.3 mg/dl ( NS ) with CaCO3 and sevelamer , respectively . Serum calcium levels and the Ca x P ion product increased with CaCO3 ; in contrast , values remained unchanged with sevelamer ( 9.6 + /- 01 versus 8.9 + /- 0.2 mg/dl ; P < 0.001 , respectively ) . Hypercalcemic episodes ( > 10.2 mg/dl ) occurred more frequently with CaCO3 ( P < 0.01 ) . Baseline PTH levels were 980 + /- 112 and 975 + /- 174 pg/ml ( NS ) ; these values decreased to 369 + /- 92 ( P < 0.01 ) and 562 + /- 164 pg/ml ( P < 0.01 ) in the CaCO3 and the sevelamer groups , respectively ( NS between groups ) . Serum alkaline phosphatase levels also diminished in both groups ( P < 0.01 ) . Thus , treatment with either CaCO3 or sevelamer result ed in equivalent control of the biochemical and skeletal lesions of 2 degrees HPT . Sevelamer , however , maintained serum calcium concentrations closer to the lower end of the normal physiologic range , thereby increasing the safety of treatment with active vitamin D sterols BACKGROUND Prior studies of dialysis practice s and outcomes have included children with varied duration of end-stage renal disease ( ESRD ) . This study evaluated dialysis characteristics , complications , practice s , and outcomes in an incident pediatric cohort . METHO
Output:
| Vitamin D therapy significantly reduced PTH levels compared with placebo or no treatment .
Bone disease , assessed by changes in PTH levels , is improved by all vitamin D preparations .
However no consistent differences between routes of administration , frequencies of dosing or vitamin D preparations have been demonstrated .
Though fewer episodes of high calcium levels occurred with the non calcium-containing binder , sevelamer , compared with calcium-containing binders , there were no differences in serum phosphorus and calcium overall and phosphorus values were reduced to similar extents .
All RCTs were small with few data available on patient-centred outcomes ( growth , bone deformities ) and limited data on biochemical parameters result ing in considerable imprecision of results thus limiting the applicability to care of children with CKD |
MS213209 | ***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 To describe the effects of age at antiretroviral therapy ( ART ) initiation on growth outcomes among children infected with HIV followed for 48 months after treatment initiation . STUDY DESIGN This secondary analysis describes anthropometric changes in children infected with HIV in Johannesburg , South Africa who initiated ritonavir-boosted lopinavir-based ART before 24 months of age and were r and omized to continue ritonavir-boosted lopinavir or to receive nevirapine after achieving and maintaining virologic suppression . Weight , height , and head circumference were measured at visits over 48 months post-ART initiation . Growth patterns including weight-for-age z-scores ( WAZs ) , height-for-age z-scores , body mass index-for-age z-scores , and head circumference for age z-score were compared between children initiating ART<6 months , 6 - 12 months , and 12 - 24 months of age . RESULTS A total of 195 children ( mean±SD age 10.7±5.9 months ) , including 54 (27.7%)<6 months , 69 ( 35.4 % ) 6 - 12 months , and 72 ( 36.9 % ) 12 - 24 months of age at ART initiation , were evaluated . In the first 12 months on treatment , children<6 months of age at ART initiation experienced more rapid improvement in WAZ ( 1.98 vs 1.44 , P=.084 ) and head circumference for age z-score ( 1.24 vs 0.45 , P=.004 ) than children who initiated ART between 12 - 24 months of age . By 48 months on ART , growth outcomes were similar , regardless of age at ART initiation . WAZ approached population norms by 12 months on ART . Although improving , height-for-age z-scores remained on average 1.0 z-score below population norms at 48 months of therapy . CONCLUSIONS Initiation of ART before 6 months of age results in more rapid growth recovery in children infected with HIV . These data provide further evidence for the importance of prompt diagnosis and early initiation of ART for infants infected with HIV Background : We assessed a nutritional support intervention in malnourished HIV-infected children in a HIV-care program of the University Hospital Gabriel Touré , Bamako , Mali . Methods : All HIV-infected children younger than 15 years were diagnosed for malnutrition between 07 and 12 , 2014 . Malnutrition was defined according to the WHO growth st and ards with Z-scores . Two types were studied : acute malnutrition ( AM ) and chronic malnutrition ( CM ) . All participants were enrolled in a 6-month prospect i ve interventional cohort , receiving Ready-To-Use Therapeutic Food , according to type of malnutrition . The nutritional intervention was offered until child growth reached −1.5 SD threshold . Six-month probability to catch up growth ( > −2 SD ) was assessed for AM using Kaplan-Meier curves and Cox model . Results : Among the 348 children screened , 198 ( 57 % ) were malnourished of whom 158 ( 80 % ) children were included : 97 ( 61 % ) for AM ( 35 with associated CM ) and 61 ( 39 % ) with CM . Fifty-nine percent were boys , 97 % were on antiretroviral therapy , median age was 9.5 years ( Interquartile Range : 6.7–12.3 ) . Among children with AM , 74 % catch-up their growth at 6-month ; probability to catch-up growth was greater for those without associated CM ( adjusted Hazard Ratio = 1.97 , CI 95 % : 1.13 to 3.44 ) . Anemia decreased significantly from 40 % to 12 % at the end of intervention ( P < 0.001 ) . Conclusions : This macronutrient intervention showed 6-month benefits for weight gain and reduced anemia among these children mainly on antiretroviral therapy for years and aged greater than 5 years at inclusion . Associated CM slows down AM recovery and needs longer support . Integration of nutritional screening and care in the pediatric HIV-care package is needed to optimize growth and prevent metabolic disorders Background Data on long-term toxicity of antiretroviral therapy ( ART ) in HIV-infected children are sparse . PENPACT-1 was an open-label trial in which HIV-infected children were assigned r and omly to receive protease inhibitor (PI)- or nonnucleoside reverse-transcriptase inhibitor (NNRTI)-based ART . Methods We examined changes in clinical , immunologic , and inflammatory markers from baseline to year 4 in the subset of children in the PENPACT-1 study who experienced viral suppression between week 24 and year 4 of ART . Liver enzyme , creatinine , and cholesterol levels and hematologic parameters were assessed during the trial . Cystatin C , high-sensitivity C-reactive protein ( hs-CRP ) , interleukin 6 ( IL-6 ) , d-dimer , and soluble CD14 ( sCD14 ) were assayed from cryopreserved specimens . Results Ninety-nine children ( 52 on PI-based and 47 on NNRTI-based ART ) met inclusion criteria . The median age at initiation of ART was 6.5 years ( interquartile range [ IQR ] , 3.7 - 13.4 years ) , and 22 % were aged <3 years at ART initiation ; 56 % of the PI-treated children received lopinavir/ritonavir , and 70 % of NNRTI-treated children received efavirenz initially . We found no evidence of significant clinical toxicity in either group ; growth , liver , kidney , and hematologic parameters either remained unchanged or improved between baseline and year 4 . Total cholesterol levels increased modestly , but no difference between the groups was found . IL-6 and hs-CRP levels decreased more after 4 years in the NNRTI-based ART group . The median change in IL-6 level was -0.35 pg/ml in the PI-based ART group and -1.0 in the NNRTI-based ART group ( P = .05 ) , and the median change in hs-CRP level was 0.25 µg/ml in the PI-based ART group and -0.95 µg/ml in the NNRTI-based ART group ( P = .005 ) . Conclusion These results support the safety of prolonged ART use in HIV-infected children and suggest that suppressive NNRTI-based regimens can be associated with lower levels of systemic inflammation INTRODUCTION Growth failure is a common feature of children with human immunodeficiency virus type 1 ( HIV-1 ) infection . Children who are treated with mono or dual nucleoside analogue reverse transcriptase inhibitor ( NRTI ) therapy show a temporary increase in weight gain and linear growth rate . In adults , protease-inhibitor-containing antiretroviral therapy is associated with a sustained weight gain and increased body mass index ( BMI ) . Experience with protease inhibitors and growth in children is still limited . The data mainly deal with short-term effects on growth . OBJECTIVE To evaluate the effect of highly active antiretroviral therapy ( HAART ) on growth in children with HIV-1 infection . DESIGN AND METHODS We analyzed selected growth parameters , clinical data , and laboratory results as part of a prospect i ve , open , uncontrolled , multicenter study to evaluate the clinical , immunologic , and virologic response to HAART consisting of indinavir , zidovudine , and lamivudine in children with HIV-1 infection . Height and weight were measured at 0 , 12 , 24 , 36 , 48 , 60 , 72 , 84 , and 96 weeks after initiation of HAART . Information about the children 's growth before enrollment in the study was retrieved from the hospital medical records and /or the school doctor or health center . BMI was calculated . z Scores were used to express the st and ard deviation ( SD ) in SD units from the Dutch reference curves for age and gender . Viral loads and CD4 + T-cell counts were examined prospect ively and related to these growth parameters . z Scores were also calculated for CD4 + T-cell counts to correct for age-related differences . A z score of 0 represents the P50 , which is exactly the age/sex-appropriate median . A height z score of -1 indicates that a child 's height is 1 SD below the age- and gender-specific median height for the normal population . Virologic responders were defined as those who either reached an undetectable viral load ( < 500 copies/mL ) or had a > 1.5 log reduction in viral load compared with baseline at week 12 after the initiation of HAART , which was maintained during the follow-up period . RESULTS . PATIENTS Twenty-four patients were included ( age : 0.4 - 16.3 years at baseline ) , with a median HIV-1 RNA load of 105 925 copies/mL ( 5.03 log ) , a median CD4 + T-cell count of 0.586 x 10(9)/L ( median z score : -2.28 SD ) , a median height z score of -1.22 , a median weight z score of -0.74 , and a median baseline BMI z score of -0.32 . Eleven patients were naive to antiretroviral therapy , and 13 patients had received previous treatment with NRTI monotherapy . Twenty children used indinavir and 4 children used nelfinavir as part of HAART . VIROLOGIC AND IMMUNOLOGIC RESPONSES TO HAART : Seventeen children were virologic responders , and 7 children were virologic nonresponders . In patients naive to NRTIs , median baseline viral loads were significantly higher than in pretreated patients . However , at weeks 48 and 96 , there was no significant difference between the viral loads of both groups . At baseline , there was no significant difference in CD4+a T-cell z scores between virologic responders and nonresponders or between naive and pretreated patients . During 96 weeks of HAART , the increase of CD4 + T-cell z score was significantly higher in responders than in nonresponders . The increase in CD4 + T-cell z score was not significantly different for naive and pretreated patients . HEIGHT , WEIGHT , AND BMI z SCORE CHANGES : We found that there was a trend toward a significantly increased z score change during 96 weeks of HAART compared with the z score change before HAART initiation for height and weight , but not for BMI . GROWTH AND VIROLOGIC RESPONSE TO HAART : When the data were analyzed separately for virologic responders and nonresponders , virologic responders showed significant increases in height and weight . The height and weight of virologic nonresponders did not change significantly . The BMI did not change significantly in responders or in nonresponders . GROWTH AND IMMUNOLOGIC RESPONSE TO HAART : The increase of weight and BMI z scores from baseline correlated positively with the CD4 + T-cell z score increase from baseline . It did not correlate with absolute CD4 + T-cell count increase . Height z score increase did not correlate with CD4 + T-cell z score or with absolute CD4 + T-cell counts . GROWTH AND PREVIOUS NRTI TREATMENT : The height z score decrease from week -48 to baseline was significantly larger in naive than in pretreated patients . The weight and BMI z score change from week -48 to baseline was not significantly different for pretreated and naive patients . From baseline to week 96 , the height and weight z score change increased significantly in naive patients but not in pretreated patients compared with the change from week -48 to baseline . The BMI z score did not change significantly over 96 weeks of HAART for naive or pretreated patients . GROWTH AND CLINICAL STAGE OF INFECTION : The clinical stage of infection according to the Centers for Disease Control and Prevention classification correlated negatively with the BMI z score and the weight z score at baseline but not with the height z score . Thus , children with the most severe clinical disease had the lowest BMI and weight z scores at baseline . The BMI z score increased more in children with more advanced clinical infection at baseline , who had lower BMI at baseline . The clinical stage of infection did not correlate with the change in weight z score from baseline to week 96 . CONCLUSIONS HAART has a positive influence effect on the growth of HIV-1-infected children . This effect is sustained for at least 96 weeks . Height and weight are favorably influenced in children in whom HAART leads to a reduction of the viral load of at least 1.5 log or to < 500 copies/mL and to an increase in the CD4 + T-cell z score . In contrast to the increase of the BMI in adults on HAART , BMI did not increase in all children effectively treated with HAART . BMI increased more in children with an advanced stage of infection and a poor nutritional status at baseline . Data from pretreated and naive patients were difficult to interpret , because the baseline characteristics of these 2 groups differed too much OBJECTIVE To evaluate the nature and magnitude of the effect of congenitally or perinatally acquired human immunodeficiency virus ( HIV ) infection on somatic growth from birth through 18 months of age . STUDY DESIGN Anthropometry was performed serially in 282 term infants born to HIV-infected women in a multicenter prospect i ve
Output:
| DATA SYNTHESIS Antiretroviral therapy has significantly reduced morbidity and mortality in HIV-infected children and is clearly associated with recovery of weight and height-for-age Z-scores , especially when started early , in the asymptomatic child still without weight-height impairment .
CONCLUSIONS HIV-infected children show early weight-height impairment ; antiretroviral therapy improves the anthropometric profile of these children |
MS213210 | ***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 compare the enamel protection efficacy of stannous-containing sodium fluoride and sodium monofluorophosphate (MFP)/triclosan dentifrices marketed in India in an in situ erosion model with acidic challenge . Material s and Methods : This r and omised and controlled , in situ , supervised , double-blind clinical trial employed a two-treatment , four-period crossover design , wherein subjects wore an appliance fitted with human enamel sample s 6 h/day during each 10 day treatment period and swished twice daily with their assigned dentifrice slurry : Oral-B ® Pro-Health ( maximum 1,000 ppm F as sodium fluoride with stannous chloride ) or Colgate ® Strong Teeth with Cavity Protection ( maximum 1,000 F as sodium MFP and triclosan ) . Subjects swished with 250 ml of orange juice over a 10 min period after each treatment and twice daily for the acidic erosive challenge . Enamel sample s were measured for tooth surface loss using contact profilometry at baseline and day 10 . Results : A total of 34 subjects were r and omised to treatment ; 32 subjects completed the final visit . Baseline profilometry measurements of the specimen surfaces were near zero within ± 0.3 μm , and no statistically significant difference ( P > 0.48 ) on average was observed between the two test dentifrices . At day 10 , the stannous-containing dentifrice demonstrated 88 % less erosion ( P < 0.0001 ) relative to the MFP/triclosan dentifrice . Estimated medians ( 95 % confidence intervals ) were 0.21 μm ( 0.17 , 0.25 ) for the stannous-containing dentifrice versus 1.66 μm ( 1.39 , 1.99 ) for the MFP/triclosan dentifrice . Both dentifrices were well-tolerated . Conclusions : Compared with MFP/triclosan toothpaste , a stabilised stannous-containing sodium fluoride dentifrice gave statistically significantly greater protection against tooth enamel surface loss in situ following repeated acid erosive challenge Objectives The aim of these investigations was to assess the ability of two fluoride dentifrices to protect against the initiation and progression of dental erosion using a predictive in vitro erosion cycling model and a human in situ erosion prevention clinical trial for verification of effectiveness . Material s and methods A stabilized stannous fluoride ( SnF2 ) dentifrice ( 0.454 % SnF2 + 0.077 % sodium fluoride [ NaF ] ; total F = 1450 ppm F ) [ dentifrice A ] and a sodium monofluorophosphate [SMFP]/arginine dentifrice ( 1.1 % SMFP + 1.5 % arginine ; total F = 1450 ppm F ) [ dentifrice B ] were tested in a 5-day in vitro erosion cycling model and a 10-day r and omized , controlled , double-blind , two-treatment , four-period crossover in situ clinical trial . In each study , human enamel specimens were exposed to repetitive product treatments using a st and ardized dilution of test products followed by erosive acid challenges in a systematic fashion . Results Both studies demonstrated statistically significant differences between the two products , with dentifrice A providing significantly better enamel protection in each study . In vitro , dentifrice A provided a 75.8 % benefit over dentifrice B ( p < 0.05 , ANOVA ) , while after 10 days in the in situ model , dentifrice A provided 93.9 % greater protection versus dentifrice B ( p < 0.0001 , general linear mixed model ) . Conclusion These results support the superiority of stabilized SnF2 dentifrices for protecting human teeth against the initiation and progression of dental erosion . Clinical relevance Stabilized SnF2 dentifrices may provide more significant benefits to consumers than conventional fluoride dentifrices OBJECTIVE To compare the enamel protection efficacy of a stabilized stannous fluoride ( SnF2 ) dentifrice to a sodium fluoride (NaF)/triclosan dentifrice following acidic erosive challenge . METHODS In this in situ , r and omized , controlled , double-blind , two-treatment , four-period crossover clinical trial , subjects wore an appliance fitted with human enamel sample s 6 h day-1 during each 15-day treatment period . Twice each treatment day they swished with their assigned dentifrice slurry : 0.454 % SnF2 /0.077 % NaF or 0.32 % NaF/0.3 % triclosan . After each treatment and two other times daily , subjects swished with 250 ml of orange juice over a 10-min period ( acidic erosive challenge ) . Enamel sample s were measured for tooth surface loss using contact profilometry at baseline and days 10 and 15 . RESULTS Thirty-six subjects ( mean age 44.8 years , range 23 - 65 years ) were r and omized to treatment ; 33 subjects completed the final study visit . There were no statistically significant baseline differences ( P > 0.44 ) in the specimen surfaces of the two dentifrice treatment groups via profilometry . At day 10 , the SnF2 dentifrice provided a statistically significant ( P < 0.0001 ) reduction in enamel loss by 67 % versus the NaF/triclosan dentifrice with estimated medians of 1.22 and 3.68 μm , respectively . At day 15 , the SnF2 dentifrice again provided a significantly greater benefit ( P < 0.0001 ) against tooth surface loss versus the NaF/triclosan dentifrice , with 68 % less erosion , and estimated medians of 1.60 and 5.03 μm , respectively . Both dentifrices were well tolerated . CONCLUSION A stabilized SnF2 dentifrice provided superior protection against the initiation and progression of tooth enamel surface loss in situ after erosive challenge compared to a NaF/triclosan dentifrice Background / Aims : Stannous fluoride ( SnF ) has been suggested as a dental erosion-preventive agent . The aim of this single-centre , r and omized , double-blind , in situ study was to evaluate the effect of toothpastes with SnF in the prevention of erosive enamel wear . Methods : A combined split-mouth ( extra-oral water or toothpaste brushing ) and crossover ( type of toothpaste ) set-up was used . Twelve volunteers wore palatal appliances containing human enamel sample s. Three toothpastes were used , in three consecutive runs , in r and omized order : two toothpastes containing SnF ( coded M and PE ) and one toothpaste containing only sodium fluoride ( coded C ) . On day 1 of each run the appliances were worn for pellicle formation . On days 2–5 the sample s were also brushed twice with a toothpaste-water slurry or only water ( control ) . Erosion took place on days 2–5 extra-orally 3 times a day ( 5 min ) in a citric acid solution ( pH 2.3 ) . Enamel wear depth was quantified by optical profilometry . The effect of toothpastes was tested using General Linear Modeling . Results : Average erosive wear depth of control sample s was 23 µm . Both SnF toothpastes significantly reduced erosive wear : M by 34 % ( SD 39 % ) and PE by 26 % ( SD 25 % ) . The control toothpaste reduced erosive wear non-significantly by 7 % ( SD 20 % ) . Both SnF-containing toothpastes significantly reduced erosive wear compared to the sodium fluoride toothpaste . Conclusion : We conclude that SnF-containing toothpastes are able to reduce erosive tooth wear in situ Although several studies have demonstrated the efficacy of AmF/NaF/SnCl2 solution in inhibiting dental erosion progression , measures for further improvement in its effectiveness are paramount . Thus , this in situ study evaluated whether the protective effect promoted by the AmF/NaF/SnCl2 solution would be enhanced by increasing its frequency of use . The study was conducted with 12 volunteers , a 4-phase ( 5 days each ) r and omized , crossover model . Extraoral erosive challenges ( 0.5 % citric acid , pH 2.6 , 6 × 2 min/day ) and rinsing protocol ( 1 or 2 × 2 min/day ) were performed . Before the in situ phase , human enamel sample s were subjected to an in vitro surface softening ( 1 % citric acid , pH 4.0 , for 3 min ) . Four treatment protocol s were tested using sample s in replicas ( n = 12 ) : group G1 - deionized water ( negative control ) ; G2 - NaF solution ( positive control , 500 ppm F- , pH 4.5 ) ; G3 - AmF/NaF/SnCl2 solution ( 500 ppm F- , 800 ppm Sn2 + , pH 4.5 ) once a day ; G4 - AmF/NaF/SnCl2 solution twice a day . Tissue loss and morphological changes were determined by optical profilometry ( n = 12 ) and scanning electron microscopy ( n = 3 ) analysis , respectively . Data were statistically analyzed by ANOVA with subsequent pairwise comparison of treatments . Tissue loss means ( ±SD in µm ) for each treatment protocol and statistical differences were found as follows : G1 4.55 ± 2.75 , G2 4.59 ± 2.13 , G3 2.64 ± 1.55 , and G4 1.34 ± 1.16 . Although there was no difference between the 2 AmF/NaF/SnCl2 solution application regimens ( once or twice a day ) , application of the product twice a day was the only treatment that was able to control erosion progression , differing from the control groups OBJECTIVES To determine if brushing dentine with 2 moderate RDA desensitising toothpastes , results in a significant dentine wear difference and whether this difference continues to be relevant when preceded with an erosive challenge . METHODS An in situ , single centre , single blind , r and omised , split mouth study , evaluated the difference in abrasion of 2 toothpastes ( SFM - Sensodyne Fresh Mint ( ® ) RDA 70 ; CPHM - Crest Pro-Health Clean Mint ( ® ) RDA 120 ) in 28 healthy volunteers . Two toothpaste treatments were administered 3 × /day , for each of the two 15 day periods , subjects wearing bi-lateral , lower buccal appliances each with 4 dentine sections . A 2 min extra-oral acidic challenge preceded toothbrushing for 2 study arms . Contact profilometry measured sample s at baseline , days 5 , 10 and 15 . RESULTS Brushing with SFM was significantly less abrasive than brushing with CPHM at all time points , with or without a preceding acidic challenge ( p<0.0001 ) . The additional dentine loss arising from the erosive challenge prior to brushing with each paste was linear with time and independent of abrasive effect . CONCLUSIONS The desensiting toothpastes ' RDA , directly related to dentine loss with toothbrushing . An acidic challenge prior to brushing did not negate the benefits of reduced wear from the lower RDA paste compared to the higher RDA paste . When brushing eroded dentine , the additional wear appeared independent of abrasive effect . Dentine hypersensitivity sufferers should be recommended to use a low-moderate RDA toothpaste , not to brush more than 2 × /day and not immediately following an acidic challenge OBJECTIVES To determine if a stabilised , stannous-containing sodium fluoride dentifrice provides greater enamel protection in situ against intraoral dietary erosive challenges compared with a sodium fluoride/potassium nitrate dentifrice . METHODS A single-centre , investigator blind , r and omised , supervised , two-treatment , non-brushing , four-period crossover in situ study was undertaken , with each test period being 15 days . Thirty-five healthy adult subjects were recruited to participate in the study , which included four erosive acid challenges per day . Subjects were r and omised to product treatment , which included either : ( 1 ) a stannous-containing sodium fluoride dentifrice ( Oral-B ( ® ) Pro-Expert Sensitive ) or ( 2 ) a sodium fluoride/potassium nitrate dentifrice ( Sensodyne ( ® ) Pronamel ( ® ) ) . Each study subject wore an intraoral appliance retaining two sterilised , polished human enamel sample s for 6 hours/day . Subjects swished with an allocated dentifrice slurry twice a day and with 250 ml of orange juice for 10 minutes ( 25 ml/minute over a 10-minute period ) four times per day . The primary and secondary outcomes for this study were enamel loss measured using contact profilometry at days 15 and 5 , respectively , using parametric analysis methods . RESULTS At day 15 , a 38 % lower enamel loss ( P < 0.0001 ) was observed , with estimated medians of 2.03 μm ( SE 0.247 ) and 3.30 μm ( SE 0.379 ) , in favour of the stannous-containing dentifrice . At day 5 , specimens treated with the stannous-containing sodium fluoride
Output:
| : The use of oral hygiene products containing AmF/NaF/SnCl2 or NaF may be effective in the prevention of erosive tooth wear |
MS213211 | ***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 current academic literature suggests there is a potential for using gardening as a tool to improve children ’s fruit and vegetable intake . This study is two parallel r and omised controlled trials ( RCT ) devised to evaluate the school gardening programme of the Royal Horticultural Society ( RHS ) Campaign for School Gardening , to determine if it has an effect on children ’s fruit and vegetable intake . Method / Design Trial One will consist of 26 schools ; these schools will be r and omised into two groups , one to receive the intensive intervention as “ Partner Schools ” and the other to receive the less intensive intervention as “ Associate Schools ” . Trial Two will consist of 32 schools ; these schools will be r and omised into either the less intensive intervention “ Associate Schools ” or a comparison group with delayed intervention . Baseline data collection will be collected using a 24-hour food diary ( CADET ) to collect data on dietary intake and a question naire exploring children ’s knowledge and attitudes towards fruit and vegetables . A process measures question naire will be used to assess each school ’s gardening activities . Discussion The results from these trials will provide information on the impact of the RHS Campaign for School Gardening on children ’s fruit and vegetable intake . The evaluation will provide valuable information for design ing future research in primary school children ’s diets and school based interventions .Trial registration IS RCT The Fast Track prevention trial was used to test hypotheses from the Early-Starter Model of the development of chronic conduct problems . We r and omly assigned 891 high-risk first- grade boys and girls ( 51 % African American ) to receive the long-term Fast Track prevention or not . After 4 years , outcomes were assessed through teacher ratings , parent ratings , peer nominations , and child self-report . Positive effects of assignment to intervention were evident in teacher and parent ratings of conduct problems , peer social preference scores , and association with deviant peers . Assessment s of proximal goals of intervention ( e.g. , hostile attributional bias , problem-solving skill , harsh parental discipline , aggressive and prosocial behavior at home and school ) collected after grade 3 were found to partially mediate these effects . The findings are interpreted as consistent with developmental theory BACKGROUND Pathways , a multisite school-based study aim ed at promoting healthful eating and increasing physical activity , was a r and omized field trial including 1704 American Indian third to fifth grade students from 41 schools ( 21 intervention , 20 controls ) in seven American Indian communities . METHODS The intervention schools received four integrated components : a classroom curriculum , food service , physical activity , and family modules . The curriculum and family components were based on Social Learning Theory , American Indian concepts , and results from formative research . Process evaluation data were collected from teachers ( n=235 ) , students ( n=585 ) , and families . Knowledge , Attitudes , and Behavior Question naire data were collected from 1150 students including both intervention and controls . RESULTS There were significant increases in knowledge and cultural identity in children in intervention compared to control schools with a significant retention of knowledge over the 3 years , based on the results of repeating the third and fourth grade test items in the fifth grade . Family members participated in Family Events and take-home activities , with fewer participating each year . CONCLUSION A culturally appropriate school intervention can promote positive changes in knowledge , cultural identity , and self-reported healthful eating and physical activity in American Indian children and environmental change in school food service 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 Background Obesity has become a global public health problem , which also affects children . It has been proposed that the educational interventions during childhood could be a key strategy in the prevention of obesity . Objective To evaluate the efficacy of an intervention on food habits and physical activity in school children . Methods A 2-year cluster-r and omised prospect i ve study with two parallel arms was used to evaluate an intervention programme in children in their first year of primary schooling ( 5–6 years of age ) in schools in the city of Granollers . The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation , Vision , Action and Change ( IVAC ) . At the beginning and at the end of the study ( 2006 and 2008 ) the weight and height of each child was measured in situ , while the families were given a self-report physical activity question naire and the Krece Plus quick test . Results Two years after the beginning of the study , the body mass index of the children in the control group was 0.89 kg/m2 higher than that of the intervention schools . The intervention reduced by 62 % the prevalence of overweight children . Similarly , the proportion of children that ate a second piece of fruit and took part in an after-school physical activity increased in the intervention group . In the control group , the weekly consumption of fish was reduced . Conclusions The educational intervention in healthy eating habits and physical activity in the school could contribute to lessen the current increase in child obesity This study examined the effectiveness of the universal component of the Fast Track prevention model : the PATHS ( Promoting Alternative THinking Strategies ) curriculum and teacher consultation . This r and omized clinical trial involved 198 intervention and 180 comparison classrooms from neighborhoods with greater than average crime in 4 U.S. locations . In the intervention schools , Grade 1 teachers delivered a 57-lesson social competence intervention focused on self-control , emotional awareness , peer relations , and problem solving . Findings indicated significant effects on peer ratings of aggression and hyperactive-disruptive behavior and observer ratings of classroom atmosphere . Quality of implementation predicted variation in assessment s of classroom functioning . The results are discussed in terms of both the efficacy of universal , school-based prevention models and the need to examine comprehensive , multiyear programs OBJECTIVE We evaluated the impact of an intervention promoting sun protection behavior among children 2 to 11 years of age through schools and day care centers , primary care practice s , and recreation areas . METHODS Ten towns in New Hampshire were paired , then assigned r and omly to intervention or control status . The multicomponent SunSafe intervention was provided to children and caregivers through primary care practice s , day care centers , schools , and beach recreation areas . Training support and material s were provided by the SunSafe project , but project staff had no direct contact with children or parents in providing the intervention . All intervention components promoted the same message : avoid the sun between 11 AM and 3 PM , cover up using hats and protective clothing , use sun block with a sun protection factor > /=15 , and encourage sun protection among family and friends . The impact of the intervention was determined by observing children 's sun protection behavior at the beach during baseline compared with 1 year later . The primary outcomes of interest were changes in the proportion of children per town using at least some sun protection and changes in the proportion of children fully protected . Children were clustered by town , with the town thus being the unit of analysis . The primary care practice component included one practice meeting for clinicians and staff at which project staff presented background on skin cancer and how to promote its prevention ; a sun protection office system manual based on our previous work , which provided specific direction on how to share responsibility among office staff and clinicians in carrying out routines that promote sun protection ; and educational posters , pamphlets , and self-adhesive reminder notes design ed to enhance sun protection counseling . SunSafe removable tattoos and stickers were offered to children at well-child and illness visits during the summer months . Schools each received three project staff visits : a brief visit with the principal to describe the intervention and to answer questions ; an in-service program to educate teachers about skin cancer and to introduce curricular material s ; and help with one parent outreach program . Larger day care centers each received one project staff visit . An additional six smaller day care centers received curricular material s through the mail but no visits . Two similar sets of curricular material s were used , one for grade schools and the other for preschools and day care centers . Both emphasized the importance of sun protection rather than the danger of skin cancer . Material s emphasized dynamic activities modeled after the " Slip , Slop , Slap " and " SunSmart " programs and included new material developed to suit regional needs . Both manuals offered structured plans but also provided a variety of activities from which teachers could choose . Teachers agreed to devote a minimum of two class periods to these material s. For recreation areas , lifeguards in each of the intervention communities attended an in-service meeting , during which background about skin cancer prevention was presented by project staff . The project also provided displays about the ultraviolet ( UV ) light index and about sun protection to be posted at each beach . Subsequently , project staff called beach staff in each community each morning with the predicted UV index for the day to post on the display . Educational pamphlets about the UV index and free sun-block sample s were available to beachgoers through the lifeguards . One brief follow-up visit by project staff was made to each beach area to provide reinforcement . RESULTS We observed 1930 children . Use of some sunscreen on at least one body area increased in all 5 intervention towns compared with paired control towns . In intervention towns , this mean proportion increased from 0.56 of those observed at baseline to 0.76 of those observed postintervention , with a minimal increase among control town children . ( ABSTRACT The primary aim of the Trial of Activity in Adolescent Girls ( TAAG ) is to test an intervention to reduce by half the age-related decline in moderate to vigorous physical activity ( MVPA ) in middle school girls . The intervention will be evaluated using a group-r and omized trial involving 36 middle schools . The primary endpoint is the mean difference in intensity-weighted minutes ( i.e. , MET-minutes ) of MVPA between intervention and comparison schools assessed using accelerometry . The TAAG study design calls for two cross-sectional sample s , one drawn from 6th grade rs at the beginning of the study and the second drawn from 8th grade rs at the end of the study following the 2-year implementation of the intervention . An important strength of this design over a cohort design is the consistency with the goals of TAAG , which focus on environmental-level rather than individual-level interventions to produce change . The study design specifies a recruitment rate of 80 % and a smaller sample of girls at baseline ( n=48 per school ) than at follow-up ( n=96 per school ) . A two-stage model will be used to test the primary hypothesis . In the first stage , MET-weighted minutes of MVPA will be regressed on school , time ( baseline or follow-up ) , their interaction , ethnicity and week of data collection . The second stage analysis will be conducted on the 72 adjusted means from the first stage . In the main-effects model , we will regress the follow-up school mean MET-weighted minutes of MVPA on study condition , adjusting for the baseline school mean . The TAAG study addresses an important health behavior , and also advances the field of group-r and omized trials through the use of a study design and analysis plan tailored to serve the main study hypothesis BACKGROUND Twenty-four-hour recalls were used to assess the change in nutrient intake among elementary-age school children exposed to the Child and Adolescent Trial for Cardiovascular Health ( CATCH ) . The purpose of this paper is to compare changes in nutrient intakes between treatment groups , sexes , ethnic groups , and the four CATCH sites . METHODS Twenty-four-hour recalls were administered to a sub sample of the CATCH cohort at baseline in third grade and following the intervention in fifth grade ( n = 1,182 ) . Changes in nutrient levels for total energy , dietary cholesterol , and dietary fiber and changes in the proportion of energy from fat , protein , carbohydrate , and fatty acids were studied looking at differences by treatment group , sex , ethnicity , and site . Mixed-model analysis of variance was used to examine the change in nutrient intake , defined as intake at follow-up minus intake at baseline . RESULTS Students in the intervention schools showed statistically significant differences in the changes in total energy and proportion of energy from total fat , saturated
Output:
| In addition , there was a lack of long-term follow-up data for most studies .We found positive effects for some interventions for : body mass index ( BMI ) , physical activity , physical fitness , fruit and vegetable intake , tobacco use , and being bullied .
Intervention effects were generally small but have the potential to produce public health benefits at the population level .
We therefore can not draw any clear conclusions as to the effectiveness of this approach for improving academic achievement .
The results of this review provide evidence for the effectiveness of some interventions based on the HPS framework for improving certain health outcomes but not others . |
MS213212 | ***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: Abstract Objective To evaluate whether routine administration of sublingual misoprostol 600 μg after delivery reduces postpartum haemorrhage . Design R and omised double blind placebo controlled trial . Setting Primary health centre in Bissau , Guinea-Bissau , West Africa . Participants 661 women undergoing vaginal delivery . Intervention Misoprostol 600 μg or placebo administered sublingually immediately after delivery . Main outcome measures Postpartum haemorrhage , defined as a loss of ≥ 500 ml and decrease in haemoglobin concentration after delivery . Results The incidence of postpartum haemorrhage was not significantly different between the two groups , the relative risk being 0.89 ( 95 % confidence interval 0.76 to 1.04 ) in the misoprostol group compared with the placebo group . Mean blood loss was 10.5 % ( −0.5 % to 20.4 % ) lower in the misoprostol group than in the control group . Severe postpartum haemorrhage of ≥ 1000 ml or ≥1500 ml occurred in 17 % ( 56 ) and 8 % ( 25 ) in the placebo group and 11 % ( 37 ) and 2 % ( 7 ) in the misoprostol group . Significantly fewer women in the misoprostol group experienced a loss of ≥1000 ml ( 0.66 , 0.45 to 0.98 ) or ≥ 1500 ml ( 0.28 , 0.12 to 0.64 ) . The decrease in haemoglobin concentration tended to be less in the misoprostol group , the mean difference between the two groups being 0.16 mmol/l ( −0.01 mmol/l to 0.32 mmol/l ) . Conclusion Sublingual misoprostol reduces the frequency of severe postpartum haemorrhage Purpose In India , two third of maternal deaths occur in rural areas where there is lack of transportation facilities , lack of refrigeration to store the injectable uterotonic drug such as oxytocin , lack of skilled personnel to administer them and lack of sterile syringes and needles . Hence , this study was conceived to evaluate misoprostol as a safe , effective , easily administered non-parenteral drug in the prevention of postpartum hemorrhage . Methods This study was conducted during the period from August 2012 to July 2014 . Low risk women with singleton pregnancy at term admitted for vaginal delivery were eligible for the study . A total of 500 women were r and omized to two groups , 250 in each group , either to receive 400 mcg misoprostol sublingually or 10 units oxytocin intramuscularly at the delivery of anterior shoulder . Patient factors , labor parameters , blood loss and side effects were noted . Results The women in both the groups were well matched with respect to age , parity , gestational age and labor parameters . There was statistical significance in the blood loss ( p = 0.04 ) between the two groups . The average blood loss was 70 ml in misoprostol group and 75 ml in oxytocin group . Shivering was the statistically significant side effect ( p = 0.004 ) in the misoprostol group and nausea was the statistically significant side effect ( p = 0.003 ) in the oxytocin group . Conclusions Sublingual misoprostol is as effective as intramuscular oxytocin as a prophylactic oxytocic in the active management of third stage of labor for prevention of postpartum hemorrhage OBJECTIVE In the poor underdeveloped countries , anaemia is very common in pregnant women . Maternal mortality is four times higher in severely anaemic women than non-anaemic ones and postpartum haemorrhage ( PPH ) is the most common cause of death . Its main cause is uterine atony , which accounts for more than 70 % . The objective of this study is to evaluate the use of sublingual misoprostol in different doses of 600 , 800 and 1000μg in management of the third stage of labor , with regards to blood loss and incidence of atonic postpartum haemorrhag ( APPH ) . STUDY DESIGN Double blind r and omized controlled study METHODS One thous and and two hundred parturient were studied in a control and three study groups , each composed of 300 women . Methylergometrine 0.2 mg IM injection and sublingual misoprostol 600 , 800 and 1000 μg tablets were given to women in control and the three study groups respectively , immediately after delivery . OUTCOME MEASURES Duration of the third stage of labour , Blood loss in the third stage of labour , Outcomes in anaemic compared to non-anaemic women , Incidance of atonic postpartum haemorrhage in different groups , Haemoglobin deficit after 24 hrs of delivery , Changes in the women 's blood pressure during the study , Side effects of the drug , and , Women 's acceptability of sublingual misoprostol administration . RESULTS Only significant reduction in blood loss and haemoglobin deficits were seen in the third stage of labour and after delivery in women used misoprostol doses of 800 μg and 1000 μg . The incidences of PPH in studied women and controls were almost similar , ranging between 2 and 3 % . Similar results were seen in anaemic and non-anaemic women with a higher incidence of APPH in the non-misoprostol user anaemic women . Side effects of the drug were dose related . CONCLUSION Misoprostol in high dose may be used for managing third stage of labour to reduce maternal morbidity and mortality due to APPH particularly , in the poor underdeveloped countries where , facilities to deliver in health centers , purchase and store the oxytocic ampoules or medically trained persons are not readily available in all places . Benefits of large dose misoprostol outweigh its side effects The haemodynamic effects of oxytocin receive scant attention in pharmacology texts , but may be clinical ly significant in vulnerable patients . Despite prescriber information recommending a dose of 5 international units by slow i.v . injection , it is the authors ' experience that it is very common practice in the UK to give 10 units as a rapid injection . We therefore conducted a r and omised , double-blind study of the haemodynamic changes induced by rapid bolus of 5 or 10 units of oxytocin in 34 healthy term parturients at caesarean section under spinal anaesthesia . There was a small but statistically significant ( P < 0.05 ) reduction in mean arterial pressure from baseline 30 s after a 10-unit bolus . However , large , statistically significant increases in heart rate and cardiac output occurred 1 min after 5 units and 2 min after 10 units . These changes peaked 1 min after oxytocin administration and were greater in the 10-unit group ( P < 0.05 ) . The importance of these findings is that some women with hypovolaemia or cardiac disease may be unable to mount these compensatory responses and are therefore at risk of haemodynamic collapse after oxytocin boluses . This has been illustrated by a maternal death reported to the Confidential Enquiries into Maternal Deaths in the United Kingdom . The need to adhere to a dose regimen of 5 units by slow injection needs re-emphasis , but no evidence exists to cl aim that even this will be haemodynamically inert . We therefore recommend that oxytocin boluses be avoided in women with hypovolaemia or cardiac disease INTRODUCTION Although the third stage of labour is usually uneventful , several significant complications may be encountered that may lead to maternal morbidity and mortality , especially primary postpartum haemorrhage . The objective of this study was to compare 400 ug oral misoprostol with 10 IU intramuscular oxytocin in the active management of the third stage of labour . METHODS This was a prospect i ve r and omised controlled clinical trial in which 200 parturients at term who had vaginal delivery were r and omly assigned into two groups : oral misoprostol and intramuscular oxytocin , after the delivery of the baby and the clamping of the umbilical cord . The primary outcome was the incidence of primary postpartum haemorrhage . Secondary outcomes included a drop in haemoglobin concentration 48 hours after delivery , the need for extra oxytocics , duration of the third stage of labour and side effects of the oxytocics . These results were subjected to statistical analysis using chi-square test or student 's t-test . RESULTS No occurrence of primary postpartum haemorrhage or significant difference in the drop in haemoglobin concentration levels was reported after delivery ( p-value is 0.49 ) , and no significant differences were observed in other secondary outcome measures with the exception of nausea , which occurred solely in the misoprostol group ( 4 percent , p-value is 0.04 ) . CONCLUSION Oral misoprostol appeared to be as effective and as safe as intramuscular oxytocin in the active management of the third stage of labour OBJECTIVE To compare the effects of oral misoprostol 800 mug with intramuscular oxytocin 10 IU in routine management of the third stage of labour . METHODS This r and omized controlled trial was performed in a rural district hospital in Ghana , West Africa , and enrolled women in labour with anticipated vaginal delivery and no known medical contraindication to prostagl and in administration . Women were r and omized to receive oral misoprostol 800 mug or intramuscular oxytocin 10 IU . Blood sample s were taken to determine hemoglobin concentration before delivery and at 12 hours post partum . Treatment was administered at delivery of the anterior shoulder . The primary outcome was the change in hemoglobin concentration from before to after delivery . Secondary outcomes included other measures of blood loss and presumed medication side effects . RESULTS In total , 450 women were enrolled in the study . Their baseline characteristics were similar . There was no significant difference between the groups in the change in hemoglobin concentration ( misoprostol 1.07 g/dL and oxytocin 1.00 g/dL ) . The only significant secondary outcomes were shivering ( 80.7 % with misoprostol vs. 3.6 % with oxytocin ) and pyrexia ( 11.4 % with misoprostol , none with oxytocin ) . CONCLUSION Routine use of oral misoprostol 800 microg appears to be as effective as 10 IU parenteral oxytocin in minimizing blood loss during the third stage of labour , as determined by change in hemoglobin concentration . Misoprostol appears to be a safe , inexpensive , and effective uterotonic for use in rural and remote areas , where intravenous oxytocin may be unavailable Summary In this study , 100 singleton pregnant women underwent a caesarean delivery under general anaesthesia and were studied in terms of postpartum bleeding using oxytocin or misoprostol . Patients were r and omly divided into two equal groups . One group received two tabs of misoprostol 200 μg sublingually and the second group took intravenous infusion of 20 units of oxytocin at the rate of 10 cc/min immediately after delivery until full contraction of the uterine . The amount of blood loss was lower in misoprostol group comparing with oxytocin group ( 608.91 ml vs 673.9 ml ) ( p = 0.048 ) and this difference was statistically significant . The need to give additional oxytocin therapy in oxytocin group ( 36 % ) was significantly higher than misoprostol group ( 14 % ) ( p = 0.032 ) . It seems that the efficacy of sublingual misoprostol is equivalent to that of low dose intravenous oxytocin in reducing postpartum haemorrhage at caesarean section . Misoprostol has some other advantages like long shelf -life , stability at room temperature and oral use International research partnerships bring together some of the best and the brightest in an effort to tackle global health problems . Such collaborations also pose complex challenges , such as maintaining ethical principles in the conduct of research in developing nations . In implementing a r and omized clinical trial to reduce postpartum hemorrhage ( PPH ) during childbirth in rural India , U.S. and Indian collaborators addressed three such issues : the appropriateness of an ethical r and omized controlled trial in the developing world , the inclusion of a placebo arm , and the relevance of informed consent in a semiliterate rural population Background The two most commonly used uterotonic drugs in caesarean section are oxytocin and carbetocin , a synthetic oxytocin analogue . Carbetocin has a longer half-life when compared to oxytocin , result ing in a reduced use of additional uterotonics . Oxytocin is known to cause fewer cardiovascular side effects when administered as a short-infusion compared to as an intravenous bolus . Based on these findings , we aim at comparing carbetocin 100 mcg given as a slow intravenous bolus with carbetocin 100 mcg applied as a short-infusion in 100 ml 0.9 % sodium chloride in women undergoing a planned or unplanned caesarean delivery . We hypothesise uterine contraction not to be inferior to a bolus application ( primary efficacy endpoint ) and greater haemodynamic stability to be achieved after a short-infusion than after a bolus administration , as measured by heart rate and mean arterial blood pressure ( primary safety endpoint ) . Methods / Design This is a prospect i ve , double-blind , r and omised controlled , investigator-initiated , non-inferiority trial taking place at the University Hospital Basel , Switzerl and .Uterine tone is quantified by manual palpation by the obstetrician using
Output:
| Two combination regimens had the poorest rankings for side-effects .
Carbetocin had similar risk for side-effects compared with oxytocin although the quality evidence was very low for vomiting and for fever , and was low for hypertension .
Ergometrine plus oxytocin combination , carbetocin , and misoprostol plus oxytocin combination were more effective for preventing PPH ≥ 500 mL than the current st and ard oxytocin .
Ergometrine plus oxytocin combination was more effective for preventing PPH ≥ 1000 mL than oxytocin .
Misoprostol plus oxytocin combination evidence is less consistent and may relate to different routes and doses of misoprostol used in the studies . |
MS213213 | ***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: Background Acetylcholinesterase inhibitors can not rapidly reverse profound neuromuscular block . Sugammadex , a selective relaxant binding agent , reverses the effects of rocuronium and vecuronium by encapsulation . This study assessed the efficacy of sugammadex compared with neostigmine in reversal of profound vecuronium-induced neuromuscular block under sevoflurane anesthesia . Methods Patients aged ≥18 years , American Society of Anesthesiologists class 1 - 4 , scheduled to undergo surgery under general anesthesia were enrolled in this phase III , multicenter , r and omized , safety-assessor blinded study . Sevoflurane anesthetized patients received vecuronium 0.1 mg/kg for intubation , with maintenance doses of 0.015 mg/kg as required . Patients were r and omized to receive sugammadex 4 mg/kg or neostigmine 70 μg/kg with glycopyrrolate 14 μg/kg at 1 - 2 post-tetanic counts . The primary efficacy variable was time from start of study drug administration to recovery of the train-of-four ratio to 0.9 . Safety assessment s included physical examination , laboratory data , vital signs , and adverse events . Results Eighty three patients were included in the intent-to-treat population ( sugammadex , n = 47 ; neostigmine , n = 36 ) . Geometric mean time to recovery of the train-of-four ratio to 0.9 was 15-fold faster with sugammadex ( 4.5 minutes ) compared with neostigmine ( 66.2 minutes ; p < 0.0001 ) ( median , 3.3 minutes with sugammadex versus 49.9 minutes with neostigmine ) . No serious drug-related adverse events occurred in either group . Conclusions Recovery from profound vecuronium-induced block is significantly faster with sugammadex , compared with neostigmine . Neostigmine did not rapidly reverse profound neuromuscular block ( Trial registration number : NCT00473694 ) Backround Sugammadex is a reversal agent with well known advantages but it ’s effects on haemostasis and bleeding have been a topic of interest . Septoplasty is a common surgical procedure with postoperative respiratory complications and bleeding . The aim of this study is to investigate the effects of sugammadex on postoperative coagulation parameters and bleeding after septoplasty procedure . Material / Methods In this r and omized controlled study , fifty patients were grouped into two groups ; neostigmine ( Group N ) vs. sugammadex ( Group S ) . For the evaluation of PT , aPTT and INR , blood sample s were taken for at the postoperative 120th minutes and alteration of these values with respect to preoperative values were documented . Postoperative bleeding was measured by evaluating the amount of blood absorbed on the nasal tip dressing during 3 hours postoperatively . Results Postoperative bleeding amount was significantly higher in the Group S compared to Group N ( p=0.013 ) . No significant difference was observed between two groups according to coagulation parameters ( PT ; p=0.953 , aPTT ; p=0.734 , INR ; p=0.612 ) . Conclusions Sugammadex was associated with higher amount of postoperative bleeding than neostigmine in septoplasty patients . In surgical procedures having high risk of bleeding the safety of sugammadex need to be verified BACKGROUND : Sugammadex , a specifically design ed & ggr;-cyclodextrin , is a selective relaxant binding drug that rapidly reverses rocuronium-induced and , to a lesser extent , vecuronium-induced neuromuscular blockade . In this study , we compared the efficacy of sugammadex and neostigmine for the reversal of vecuronium-induced neuromuscular blockade in patients scheduled for elective surgery . METHODS : Patients aged ≥18 yr , ASA Class I – III , and scheduled for a surgical procedure under sevoflurane/opioid anesthesia received an intubating dose of vecuronium ( 0.1 mg/kg ) and maintenance doses of 0.02–0.03 mg/kg at reappearance of the second twitch ( T2 ) of train-of-four ( TOF ) if required . Neuromuscular blockade was monitored using acceleromyography ( TOF-Watch ® SX , Schering-Plough Irel and , Dublin , Irel and ) . At end of surgery , at reappearance of T2 after the last dose of vecuronium , patients were r and omized to receive either sugammadex ( 2 mg/kg ) or neostigmine ( 50 & mgr;g/kg ) plus glycopyrrolate ( 10 & mgr;g/kg ) IV . The primary efficacy end-point was time from start of administration of sugammadex or neostigmine to recovery of TOF ratio to 0.9 . RESULTS : The geometric mean time to recovery of the TOF ratio to 0.9 was significantly faster with sugammadex compared with neostigmine ( 2.7 min [ 95 % confidence interval { CI } ] : 2.2–3.3 ) versus 17.9 min [ 95 % CI : 13.1–24.3 ] , respectively ; P < 0.0001 ) . The mean recovery times to a TOF ratio of 0.8 and 0.7 were also significantly shorter with sugammadex . No serious adverse events or unexpected side effects were reported with either drug . CONCLUSION : Sugammadex provided significantly faster reversal of vecuronium-induced neuromuscular blockade compared with neostigmine Background This study compared efficacy and safety of the selective relaxant binding agent sugammadex ( 2 mg/kg ) with neostigmine ( 50 μg/kg ) for neuromuscular blockade ( NMB ) reversal in Chinese and Caucasian subjects . Methods This was a r and omized , active-controlled , multicenter , safety-assessor-blinded study ( NCT00825812 ) in American Society of Anesthesiologists Class 1 - 3 subjects undergoing surgery with propofol anesthesia . Rocuronium 0.6 mg/kg was administered for endotracheal intubation , with 0.1–0.2 mg/kg maintenance doses given as required . NMB was monitored using TOF-Watch ® SX . At second twitch reappearance , after last rocuronium dose , subjects received sugammadex 2 mg/kg or neostigmine 50 μg/kg plus atropine 10–20 μg/kg , according to r and omization . Primary efficacy variable was time from sugammadex/neostigmine to recovery of the train-of-four ( TOF ) ratio to 0.9 . Results Overall , 230 Chinese subjects ( sugammadex , n = 119 , neostigmine , n = 111 ) ; and 59 Caucasian subjects ( sugammadex , n = 29 , neostigmine , n = 30 ) had evaluable data . Geometric mean ( 95 % CI ) time to recovery to TOF ratio 0.9 was 1.6 ( 1.5–1.7 ) min with sugammadex vs 9.1 ( 8.0–10.3 ) min with neostigmine in Chinese subjects . Corresponding times for Caucasian subjects were 1.4 ( 1.3–1.5 ) min and 6.7 ( 5.5–8.0 ) min , respectively . Sugammadex 2 mg/kg was generally well tolerated , with no serious adverse events reported . There was no residual NMB or recurrence of NMB . Conclusion Both Chinese and Caucasian subjects recovered from NMB significantly faster after sugammadex 2 mg/kg vs neostigmine 50 μg/kg , with a ~5.7 times ( p < 0.0001 ) faster recovery with sugammadex vs neostigmine in Chinese subjects . Sugammadex was generally well tolerated . Trial registration Clinical Trials.gov Identifier : NCT00825812 Background Rapid and complete reversal of neuromuscular blockade ( NMB ) is desirable at the end of surgery . Sugammadex reverses rocuronium-induced NMB by encapsulation . It is well tolerated in Caucasian patients , providing rapid reversal of moderate ( reappearance of T2 ) rocuronium-induced NMB . We investigated the efficacy and safety of sugammadex versus neostigmine in Korean patients . Methods This r and omized , safety assessor-blinded trial ( NCT01050543 ) included Korean patients undergoing general anesthesia . Rocuronium 0.6 mg/kg was given prior to intubation with maintenance doses of 0.1 - 0.2 mg/kg as required . Patients received sugammadex 2.0 mg/kg or neostigmine 50 µg/kg with glycopyrrolate 10 µg/kg to reverse the NMB at the reappearance of T2 , after the last rocuronium dose . The primary efficacy endpoint was the time from sugammadex or neostigmine administration to recovery of the train-of-four ( TOF ) ratio to 0.9 . The safety of these medications was also assessed . Results Of 128 r and omized patients , 118 had evaluable data ( n = 59 in each group ) . The geometric mean ( 95 % confidence interval ) time to recovery of the TOF ratio to 0.9 was 1.8 ( 1.6 , 2.0 ) minutes in the sugammadex group and 14.8 ( 12.4 , 17.6 ) minutes in the neostigmine group ( P < 0.0001 ) . Sugammadex was generally well tolerated , with no evidence of residual or recurrence of NMB ; four patients in the neostigmine group reported adverse events possibly indicative of inadequate NMB reversal . Conclusions Sugammadex was well tolerated and provided rapid reversal of moderate rocuronium-induced NMB in Korean patients , with a recovery time 8.1 times faster than neostigmine . These results are consistent with those reported for Caucasian patients The frequency and duration of postoperative residual neuromuscular block on arrival of 150 patients in the recovery ward following the use of vecuronium ( n = 50 ) , atracurium ( n = 50 ) and rocuronium ( n = 50 ) were recorded . Residual block was defined as a train‐of‐four ratio of < 0.8 . An additional group of 10 patients received no neuromuscular blocking drugs during anaesthesia . The incidence of postoperative residual neuromuscular block was 64 % , 52 % and 39 % after the use of vecuronium , atracurium and rocuronium , respectively . Similar numbers of patients were not able to maintain a sustained head or leg lift for 5 s on arrival in the recovery ward . The mean [ range ] times to attaining a train‐of‐four ratio of ≥0.8 after arrival in the recovery ward were 9.2 [ 1–61 ] , 6.9 [ 1–24 ] and 14.7 [ 1.5–83 ] min for vecuronium , atracurium and rocuronium , respectively . None of the 10 patients who did not receive neuromuscular blocking drugs had train‐of‐four ratios < 0.8 on arrival in the recovery ward . It is concluded that a large proportion of patients arrive in the recovery ward with a train‐of‐four ratio < 0.8 , even with the use of intermediate‐acting neuromuscular blocking drugs . Although the residual block is relatively short lasting , it may occasionally be prolonged , requiring close observation and monitoring of such patients in the recovery ward BACKGROUND Sugammadex is a selective relaxant binding agent design ed to encapsulate the neuromuscular blocking agent , rocuronium . The sugammadex-rocuronium complex is eliminated by the kidneys . This trial investigated the pharmacokinetics ( PKs ) of sugammadex and rocuronium in patients with renal failure and healthy controls . METHODS Fifteen ASA class II-III renal patients [ creatinine clearance ( CL(CR ) ) < 30 ml min(-1 ) ] and 15 ASA I-II controls ( CL(CR ) > or = 80 ml min(-1 ) ) were included . After induction of anaesthesia , a single i.v . dose of rocuronium 0.6 mg kg(-1 ) was given , followed by a single i.v . dose of sugammadex 2.0 mg kg(-1 ) at reappearance of the second twitch of the train-of-four response . Plasma concentrations of rocuronium and sugammadex were estimated and PK variables determined using non-compartmental analyses . Percentages of sugammadex and rocuronium excreted in the urine were measured . RESULTS PK data were obtained from 26 patients . Mean total plasma clearance ( CL ) of sugammadex was 5.5 ml min(-1 ) in renal patients and 95.2 ml min(-1 ) in controls ( P<0.05 ) . Rocuronium CL was 41.8 ml min(-1 ) in renal patients and 167 ml min(-1 ) in controls ( P<0.05 ) . The median amount of sugammadex and rocuronium excreted in the urine over 72 h in renal patients was 29 % and 4 % , respectively , and 73 % and 42 % over 24 h in controls . CONCLUSIONS Large differences in the PKs of sugammadex and rocuronium between patients with renal failure and healthy controls were observed . The effect of renal impairment on the PK variables of rocuronium was less than with sugammadex . Urinary excretion of both drugs was reduced in renal patients Background Sugammadex is a
Output:
| Finally , we found no significant differences between sugammadex and neostigmine regarding risk of serious adverse events ( RR 0.54 , 95 % CI 0.13 to 2.25 ; I2= 0 % ; 10 studies , n = 959 ; GRADE : low quality ) .Application of trial sequential analysis ( TSA ) indicates superiority of sugammadex for outcomes such as recovery time from T2 to TOFR > 0.9 , adverse events , and overall signs of postoperative residual paralysis .
AUTHORS ' CONCLUSIONS Review results suggest that in comparison with neostigmine , sugammadex can more rapidly reverse rocuronium-induced neuromuscular block regardless of the depth of the block .
With an NNTB of 8 to avoid an adverse event , sugammadex appears to have a better safety profile than neostigmine . |
MS213214 | ***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: In an ongoing prospect i ve study at 2 hospitals , 114 cesarean section patients were studied to determine whether giving ampicillin after umbilical cord clamping is as effective as perioperative ampicillin in reducing maternal postoperative morbidity . The same patients have also been studied to determine the effect of prophylactic cesarean section ampicillin on the newborn . Results have shown that prophylactic ampicillin initiated after cord clamping is as effective in reducing maternal morbidity as ampicillin initiated prior to the surgery . There is also no evidence from our study that the transplacental passage of prophylactic ampicillin increases immediate or delayed neonatal infections A prospect i ve r and omized clinical trial was conducted to test the effectiveness of long-term and short-term prophylaxis with cefuroxime in preventing morbidity after cesarean section . Sixty patients who required emergency cesarean section were r and omly assigned to one of three treatment groups : a control group of 20 patients receiving no prophylactic antibiotics ; a group of 20 patients receiving 24 hours of cefuroxime prophylaxis ( 0.75 gm 30 to 60 minutes before surgery and at 8 hours and 16 hours after surgery ) ; and a group of 20 patients receiving five days of cefuroxime prophylaxis ( 0.75 gm three times a day , the first dose being given postoperatively ) . The short-term and long-term prophylaxes were equally effective in reducing morbidity , assessed by postoperative temperatures , presence or absence of endometritis , and duration of postoperative hospital stay The effectiveness of a single prophylactic dose of two broad spectrum antibiotics , during Caesarean section , was compared and evaluated . In 119 consecutive cases at the Cantonal Hospital in Winterthur , Switzerl and , either 1 g i.v . cefotaxime or 1,2 g amoxicillin plus clavulanic acid were administered after clamping the umbilical cord during Caesarean section . The study shows that single dose prophylaxis of either regimen provides adequate cover in preventing morbidity in Caesarean section , in both high-risk and low-risk groups In a prospect i ve , r and omized trial , the efficacy of a single-dose , first-generation , long-acting cephalosporin was compared with a three-dose regimen in a group of 100 women undergoing cesarean section who were at high risk for postoperative febrile morbidity . Fifty women received a single 1 gm intravenous dose of cefazolin and 50 received 1 gm of the drug followed by two additional doses , 8 hours apart , to complete a three-dose regimen . Another 50 women , considered to be at low risk for postoperative febrile morbidity , were not given antibiotic prophylaxis . Outcomes of febrile morbidity ( 18 % vs 12 % ) and particularly morbidity caused by endometritis ( 6 % vs 8 % , respectively ) were similar for single-dose and three-dose groups . In the untreated low-risk group there were no cases of endometritis and the febrile morbidity was comparable to that of the prophylactically treated groups ( 14 % vs 15 % ) . Single-dose cefazolin prophylaxis appears to be comparable to multidose prophylaxis in reducing febrile morbidity after cesarean section The use of antibiotics for prophylaxis against infection among women undergoing nonelective cesarean section has become the st and ard of care in the United States . Many different antibiotics have been used successfully . Single-dose regimens administered after the cord is clamped have proven just as effective as multiple-dose regimens . Although the most frequently used class of antibiotics is the cephalosporin family , the single best agent has not been determined . This study was a double-blind , r and omized trial in which we compared a narrow-spectrum cephalosporin ( cefazolin ; n = 63 ) with an exp and ed-spectrum cephamycin ( cefoxitin ; n = 66 ) and with a broad-spectrum cephalosporin ( cefotaxime ; n = 60 ) used as a single-dose prophylaxis in patients undergoing a nonelective cesarean section . Of the 194 patients enrolled in the study , 189 were evaluable . There was no significant difference between the groups in mean age , gravidity , parity , duration of labor , duration of ruptured membranes , number of vaginal examinations , or socioeconomic status ( socioeconomic status was defined by third-party coverage ) . There was no significant difference among the antibiotics in the incidence of immediate or delayed postoperative infections . These data indicate that a less expensive , narrow-spectrum cephalosporin is as effective as more expensive , broader-spectrum cephamycins and cephalosporins as prophylaxis for patients undergoing nonelective cesarean section This study compared the efficacy of a single intravenous dose of Cefazolin alone or combined with an antibiotic containing preclosure-irrigation solution in patients undergoing cesarean section . A total of 308 patients were prospect ively assigned to two groups by r and omization . Group I received two grams of Cefazolin IV and abdomino-peritoneal irrigation with saline . Group II received one gram of Cefazolin IV and one gram in the saline irrigation solution . The rate of total postoperative morbidity was 2.3 times higher in Group I compared to Group II ( 16/154 or 10.4 % vs 7/154 or 4.5 % ) and morbidity at the operative site was six times higher ( 13/154 or 8.4 % vs 2/154 or 1.3 % ) A r and omized , prospect i ve , double-blind study was design ed to compare intravenous administration with intrauterine irrigation using an extended half-life ( tl/2=three hours ) cephalosporin , ceforanide . Patients included in the study had a nonelective cesarean section with rupture of membranes for three hours or longer . Sixty-four patients received a single dose of ceforanide immediately after clamping the umbilical cord . Patients were similar in both groups in age , weight , length of labor , and duration of ruptured membranes . The group receiving the intravenous ceforanide had a significantly shorter duration of surgery than the patients receiving the intrauterine ceforanide . Endometritis infection rates were similar , 11.8 % ( intravenous ) versus 11.1 % ( intrauterine ) , P>.1 . Serum levels were as much as tenfold higher in the intravenous group versus the intrauterine group . Intrauterine irrigation with an antimicrobial agent provided no advantage over systemic administration A prospect i ve and r and omized study was undertaken to determine the safety and efficacy of low price and discouraging bacterial resistance agents , given for 12 hours versus 72 hours , as prophylaxis at cesarean section . Ninety six patients received penicillin ( ten million units ) intravenously and tetracycline ( 0.25 g ) intramuscularly at cord clamping and 12 hours postoperatively ( table I ) . Among them 14 % of febrile morbidity was recorded ( table II ) . Eighty seven patients received the same treatment followed by oral ampicillin ( 2 g ) and tetracycline ( 1.5 g ) per day , for a further 60 hours ( table I ) . Maternal febrile morbidity was not further reduced by the oral additional treatment ( table II ) . This regiment prophylactic effect is comparable to previous reported data concerning other protocol s , and even better , while expenses are reduced and efficacy for important pathogens such as chlamydia and mycoplasma is obtained . No side effects of the drugs were recorded To study the effectiveness of anaerobic coverage in prevention of postpartum endometritis in women undergoing nonelective cesarean sections , we conducted a r and omized prospect i ve double-blind study of women undergoing cesarean sections and requiring antibiotic prophylaxis from April 1 , 1989 , through December 31 , 1990 . Ninety-four patients were enrolled in the study . Forty-five patients received ampicillin alone and 46 received ampicillin in conjunction with sulbactam . All patients were evaluated prior to surgery and in the postoperative period . Ninety-one patients completed the study and their records were analyzed . Patients were divided into two groups depending on the presence or absence of ruptured membranes . Seventy-five percent of patients had ruptured membranes . Failure of prophylaxis and subsequent endometritis was documented in 8.8 % of patients who received ampicillin and sulbactam and 35.3 % of patients who received ampicillin alone . This difference was statistically significant ( p < 0.02 ) . In conclusion , single-dose ampicillin and sulbactam provides better prophylaxis than single-dose ampicillin in women undergoing cesarean section with rupture of membranes A prospect i ve r and omized study was undertaken in 100 patients undergoing cesarean section to evaluate the efficacy of cefotaxime when given as a single-dose versus the more traditional triple-dose regimen for prophylaxis . Analysis of the results demonstrated no significant differences in febrile morbidity ( 14 versus 20 % ) or postoperative endometritis ( 10 versus 14 % between the single- and triple-dose groups , respectively . Pretherapy aerobic and anaerobic placental cultures were positive in 60 % of the overall study population . In those patients who subsequently developed endometritis , seven ( 58 % ) had a positive placental culture , suggesting that this technique is relatively nonspecific as a screening procedure . Results of transcervical culture in the endometritis patients most often demonstrated a polymicrobial picture . Several of the organisms cultured were found to be resistant to cefotaxime , supporting the need to better guide antimicrobial therapy by routine endometrial culturing in patients who fail prophylaxis . The results of the present study suggest that single-dose administration of cefotaxime is equally effective as triple-dose therapy in reducing postcesarean section endometritis The purpose of this prospect i ve investigation was to compare a single intravenous dose of cefazolin to a single dose of cefonicid as prophylaxis for women having unscheduled cesarean delivery . In a double-blind , r and omized design , 96 patients were assigned to receive a 1-g dose of cefazolin and 103 patients were design ated to receive a 1-g dose of cefonicid . The antibiotics were administered after delivery of the infant . The two groups were comparable with respect to recognized risk factors for postcesarean infection . There were no statistically significant differences between the groups in the incidence of st and ard febrile morbidity , endomyometritis , urinary tract infection , wound infection , and bacteremia . There were also no significant differences between the groups in the fever index or the duration of hospitalization . We conclude that cefazolin and cefonicid provide a similar degree of prophylaxis against infection in patients having unscheduled cesarean delivery This study included 207 patients in a double-blind , prospect i ve r and omized trial of cefazolin veisus cefam and ole single-dose prophylaxis by both intravenous ( IV ) and lavage routes in patients laboring with ruptured membranes who eventually had nonelective cesareans . No significant differences ( P < .05 ) were noted in the rates of infectious morbidity ( cefazolin IV : six of 47 , 13 % ; cefazolin lavage : nine of 59 , 15 % ; cefam and ole IV : six of 47 , 13 % ; cefam and ole lavage : six of 54 , 11 % ) . The incidence of operative complications in the patients developing endometritis ( eight of 22 , 36 % ) was significantly different ( P < .004 ) from that in the group who did not develop endometritis ( 21 of 185 , 11 % ) . Cefazolin by IV and lavage routes of administration appears to be as effective as cefam and ole by either route of administration A study comparing the efficacy of cefotetan versus cefoxitin for prophylaxis in patients undergoing cesarean section was carried out at the University of Iowa . After institutional review , 36 subjects who met the study criteria and agreed to participate were entered into the study ; of these , 29 were evaluable for efficacy . Twenty subjects received a single 2 gm dose of cefotetan , and nine subjects received three 2 gm doses each of cefoxitin . Both antibiotics were administered intravenously at the time the umbilical cord was clamped . The subsequent doses of cefoxitin were given intravenously at four and eight hours after the initial dose . Clinical and bacteriologic responses were evaluated ; there were no statistically significant differences between the two groups , and both antibiotics provided effective prophylaxis against infection . It appears that cefotetan is a satisfactory antibiotic choice for cesarean section prophylaxis . Further , in this small study it appears that a single dose of cefotetan is as effective as three doses of cefoxitin . This implies that cefotetan would not only decrease administration time and supplies but would decrease the cost to the patient while maintaining very acceptable infection rates Despite the increasing popularity of antibiotic prophylaxis to reduce febrile morbidity in patients who undergo cesarean delivery , little is known of the pharmacokinetics of antibiotics in the patient at term gestation . This study was design ed to eluci date
Output:
| REVIEW ER 'S CONCLUSIONS Both ampicillin and first generation cephalosporins have similar efficacy in reducing postoperative endometritis .
There does not appear to be added benefit in utilizing a more broad spectrum agent or a multiple dose regimen . |
MS213215 | ***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 explore the effect of training on patient-actor perception of care during simulated obstetric emergencies . Method : A sub analysis from a prospect i ve r and omised controlled trial in six UK hospitals and the Bristol Medical Simulation Centre , UK . Midwives and doctors working in participating hospitals were eligible for inclusion . 140 participants ( 22 junior and 23 senior doctors , 47 junior and 48 senior midwives ) were r and omised to one of four obstetric emergency training interventions : 1-day course at local hospitals ; 1-day course at simulation centre ; 2-day course with teamwork training at local hospitals ; and 2-day course with teamwork training at simulation centre . Local training used patient-actors and low-fidelity part-task trainers whereas simulation centre training used full-bodied computerised manikins and high-fidelity part-task trainers . Three weeks before and after the training , the participants managed three simulated obstetric emergencies . Patient-actors scored their care after each simulation using a patient-actor perception score ( communication , safety , respect ) . Results : The following numbers of scores were awarded : 139 and 132 participant and 46 and 48 team scenarios , before and after training , respectively . There was a significant improvement in all scores in all scenarios after the training ( p = 0.017 to > 0.001 ) . Perception of safety and communication during postpartum haemorrhage was significantly improved following training with patient-actors compared with training with manikins ( safety p = 0.048 , communication p = 0.035 ) . Teamwork training offered no additional benefit to patient-actors ’ perception of their care . Conclusions : All multiprofessional training improved patient-actor perception of care . Training using a patient-actor may be better at improving perception of safety and communication than training with a computerised manikin simulator Objectives To determine the effect of training residents in interpersonal and communication skills on women ’s satisfaction with doctor – woman relationship in labour and delivery rooms . Design A stepped wedge cluster r and omised trial . Setting 4 tertiary care teaching maternity hospitals in Damascus , Syria . Participants 2000 women who gave birth to a living baby in the four study hospitals and consented to participate in the intervention took part in the study . Women with difficult labour and high-risk pregnancies were excluded . All were interviewed at home after discharge . Interventions A specially design ed training package in communication skills was delivered to all resident doctors at the four hospitals . Primary outcome measures The main outcome measure was women ’s satisfaction with interpersonal relationships in labour and delivery rooms measured via a series of questions on a Likert scale modified from the Medical Interview Satisfaction Scale . Results At the individual level , the mean for the average satisfaction score was 3.23 ( SD 0.72 ) of a possible score of 5 in the control group and 3.42 ( SD 0.73 ) in the intervention group . Using generalised linear mixed models , we were unable to detect a difference between the mean for the average satisfaction score of women in the intervention arm and that of women in the control arm ; the 95 % CI associated with the effect of the intervention ranged from –0.08 to 0.15 . Conclusions Despite slight changes in the observed residents ’ communication skills , the training package in communication skills does not seem to be associated with higher satisfaction scores of women . This raises the question of whether training individuals without further structural changes in the delivery of care and without further reinforcement of the training can have an impact on improving the quality of doctor – patient communication . Trial Registration Number IS RCT Background To assess the student perspective on acceptability , realism , and perceived effect of communication training with peer role play ( RP ) and st and ardised patients ( SP ) . Methods 69 prefinal year students from a large German medical faculty were r and omly assigned to one of two groups receiving communication training with RP ( N = 34 ) or SP ( N = 35 ) in the course of their paediatric rotation . In both groups , training addressed major medical and communication problems encountered in the exploration and counselling of parents of sick children . Acceptability and realism of the training as well as perceived effects and applicability for future parent-physician encounters were assessed using six-point Likert scales . Results Both forms of training were highly accepted ( RP 5.32 ± .41 , SP 5.51 ± .44 , n.s . ; 6 = very good , 1 = very poor ) and perceived to be highly realistic ( RP 5.60 ± .38 , SP 5.53 ± .36 , n.s . ; 6 = highly realistic , 1 = unrealistic ) . Regarding perceived effects , participation was seen to be significantly more worthwhile in the SP group ( RP 5.17 ± .37 , SP 5.50 ± .43 ; p < .003 ; 6 = totally agree , 1 = do n't agree at all ) . Both training methods were perceived as useful for training communication skills ( RP 5.01 ± .68 , SP 5.34 ± .47 ; 6 = totally agree ; 1 = do n't agree at all ) and were considered to be moderately applicable for future parent-physician encounters ( RP 4.29 ± 1.08 , SP 5.00 ± .89 ; 6 = well prepared , 1 = unprepared ) , with usefulness and applicability both being rated higher in the SP group ( p < .032 and p < .009 ) . Conclusions RP and SP represent comparably valuable tools for the training of specific communication skills from the student perspective . Both provide highly realistic training scenarios and warrant inclusion in medical curricula . Given the expense of SP , deciding which method to employ should be carefully weighed up . From the perspective of the students in our study , SP were seen as a more useful and more applicable tool than RP . We discuss the potential of RP to foster a greater empathic appreciation of the patient perspective
Output:
| The study from Syria reported that a communication skills training intervention for resident doctors was not associated with higher satisfaction reported by women .
In the UK study , patient-actors ' ( experienced midwives ) perceptions of safety and communication significantly improved for postpartum haemorrhage scenarios after training with patient-actors in local hospitals , compared with training using manikins in simulation centres , but no differences were identified for other scenarios .
KEY CONCLUSIONS AND IMPLICATION S FOR PRACTICE the review identified a lack of evidence on impact of interventions to support effective communication between maternity care staff and healthy women during labour and birth .
Very low quality evidence was found on effectiveness of communication training of maternity care staff . |
MS213216 | ***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: In the present experiment we obtained the tensile properties of the human gastrocnemius tendon , a high-stressed tendon suitable for spring-like action during locomotion . Measurements were taken in vivo in six men . The gastrocnemius tendon elongation during tendon loading-unloading induced by muscle contraction-relaxation was measured using real-time ultrasonography . Tendon forces were calculated from the moment generated during isometric plantarflexion contraction , using tendon moment arm length data obtained in vivo with the tendon travel method . Tendon stiffness data were calculated from the slope of the tendon force-elongation curve , and were then normalized to the tendon 's original dimensions , obtained from morphometric analysis of sonographs , to estimate the tendon Young 's modulus . Mechanical hysteresis values were obtained from area calculations by numerical integration . The elongation of the tendon increased curvilinearly with the force acting upon it , from 1.7+/-1 mm ( 0.8+/-0.3 % strain ) at 87.5+/-8.5 N to 11.1+/-3.1 mm ( 4.9+/-1 % strain ) at 875+/-85 N. The tendon Young 's modulus and mechanical hysteresis were 1.16+/-0.15 GPa and 18+/-3 % , respectively . These values fall within the range of values obtained from in vitro experiments and are very similar to the respective values recently obtained from in vivo measurements in the less highly stressed human tibialis anterior tendon ( 1.2 GPa and 19 % ) , thus indicating that the material properties of tendon are independent of physiological loading and function . Combining the present tendon force-elongation data with previously reported Achilles tendon force data recorded during walking indicates that the gastrocnemius tendon would provide approximately 6 % of the total external work produced by the locomotor system . This estimate illustrates the contribution of passive elastic mechanisms on the economy and efficiency of walking . The contributions would be greater in more active exercise such as running The aim of the present study was to investigate the behavior of human muscle fascicles during dynamic contractions . Eight subjects performed maximal isometric dorsiflexion contractions at six ankle joint angles and maximal isokinetic concentric and eccentric contractions at five angular velocities . Tibialis anterior muscle architecture was measured in vivo by use of B-mode ultrasonography . During maximal isometric contraction , fascicle length was shorter and pennation angle larger compared with values at rest ( P < 0.01 ) . During isokinetic concentric contractions from 0 to 4.36 rad/s , fascicle length measured at a constant ankle joint angle increased curvilinearly from 49.5 to 69.7 mm ( 41 % ; P < 0.01 ) , whereas pennation angle decreased curvilinearly from 14.8 to 9.8 degrees ( 34 % ; P < 0.01 ) . During eccentric muscle actions , fascicles contracted quasi-isometrically , independent of angular velocity . The behavior of muscle fascicles during shortening contractions was believed to reflect the degree of stretch applied to the series elastic component , which decreases with increasing contraction velocity . The quasi-isometric behavior of fascicles during eccentric muscle actions suggests that the series elastic component acts as a mechanical buffer during active lengthening The aim of this study was to determine the effects of 14 wk of plyometric training on mechanical properties of the Achilles tendon . Nineteen subjects were r and omly assigned to trained or control group . Cross-sectional area ( CSA ) , stiffness , and dissipation coefficient of the Achilles tendon were measured before and after the training period . In the trained group , a decrease in dissipation coefficient ( -35.0 % ; P<0.05 ) and an upward trend in stiffness ( + 24.1 % ) of the Achilles tendon was found , without any changes in Achilles tendon CSA ( P>0.05 ) . Plyometric training enhances the muscular tension transmission mainly through a reduction in energy dissipated by the tendon . The lack of changes in the Achilles tendon CSA indicates that changes in mechanical properties would mainly result from a qualitative change in tendinous tissues rather than from changes in the geometry of the Achilles tendon While microgravity exposure is known to cause deterioration of skeletal muscle performance , little is known regarding its effect on tendon structure and function . Hence , the aims of this study were to investigate the effects of simulated microgravity on the mechanical properties of human tendon and to assess the effectiveness of resistive counter measures in preventing any detrimental effects . Eighteen men ( aged 25 - 45 yr ) underwent 90 days of bed rest : nine performed resistive exercise during this period ( BREx group ) , and nine underwent bed rest only ( BR group ) . Calf-raise and leg-press exercises were performed every third day using a gravity-independent flywheel device . Isometric plantar flexion contractions were performed by using a custom-built dynamometer , and ultrasound imaging was used to determine the tensile deformation of the gastrocnemius tendon during contraction . In the BR group , tendon stiffness estimated from the gradient of the tendon force-deformation relation decreased by 58 % ( preintervention : 124 + /- 67 N/mm ; postintervention : 52 + /- 28 N/mm ; P < 0.01 ) , and the tendon Young 's modulus decreased by 57 % postintervention ( P < 0.01 ) . In the BREx group , tendon stiffness decreased by 37 % ( preintervention : 136 + /- 66 N/mm ; postintervention : 86 + /- 47 N/mm ; P < 0.01 ) , and the tendon Young 's modulus decreased by 38 % postintervention ( P < 0.01 ) . The relative decline in tendon stiffness and Young 's modulus was significantly ( P < 0.01 ) greater in the BR group compared with the BREx group . Unloading decreased gastrocnemius tendon stiffness due to a change in tendon material properties , and , although the exercise counter measures did attenuate these effects , they did not completely prevent them . It is suggested that the total loading volume was not sufficient to completely prevent alterations in tendon mechanical properties Architectural properties of the triceps surae muscles were determined in vivo for six men . The ankle was positioned at 15 degrees dorsiflexion ( -15 degrees ) and 0 , 15 , and 30 degrees plantar flexion , with the knee set at 0 , 45 , and 90 degrees . At each position , longitudinal ultrasonic images of the medial ( MG ) and lateral ( LG ) gastrocnemius and soleus ( Sol ) muscles were obtained while the subject was relaxed ( passive ) and performed maximal isometric plantar flexion ( active ) , from which fascicle lengths and angles with respect to the aponeuroses were determined . In the passive condition , fascicle lengths changed from 59 , 65 , and 43 mm ( knee , 0 degrees ; ankle , -15 degrees ) to 32 , 41 , and 30 mm ( knee , 90 degrees ankle , 30 degrees ) for MG , LG , and Sol , respectively . Fascicle shortening by contraction was more pronounced at longer fascicle lengths . MG had greatest fascicle angles , ranging from 22 to 67 degrees , and was in a very disadvantageous condition when the knee was flexed at 90 degrees , irrespective of ankle positions . Different lengths and angles of fascicles , and their changes by contraction , might be related to differences in force-producing capabilities of the muscles and elastic characteristics of tendons and aponeuroses Plyometric training is commonly used to improve athletic performance ; however , it is unclear how each component of the muscle – tendon complex ( MTC ) is affected by this intervention . The effects of 14 weeks of plyometric training on the passive stiffness of the gastrocnemii muscles and Achilles tendon was determined simultaneously to assess possible local adaptations of elastic properties . The passive force – length relationship of the gastrocnemii MTC and elongation of the gastrocnemii muscles were determined using ultrasonography during passive cyclic stretching in 19 subjects divided into trained ( n = 9 ) and control ( n = 10 ) groups . An upward trend in stiffness of the gastrocnemii MTC ( P = 0.09 ) and a significant increase in the intrinsic gastrocnemii muscle stiffness were found ( P < 0.05 ) . In contrast , no significant change in gastrocnemii tendon stiffness , or in muscle and tendon geometry , was determined ( P > 0.05 ) . Considering the lack of change in gastrocnemii muscle geometry , the change in the gastrocnemii muscle stiffness may be mainly due to a change in the intrinsic mechanical properties of the muscular tissues Objective : To prospect ively investigate tendon thickness and tendon structure by ultrasonography in patients treated with eccentric calf muscle training for painful chronic Achilles tendinosis located at the 2–6 cm level in the tendon . Methods : The patients were examined with grey scale ultrasonography before and 3.8 years ( mean ) after the 12 week eccentric training regimen . At follow up , a question naire assessed present activity level and satisfaction with treatment . Results : Twenty six tendons in twenty five patients ( 19 men and six women ) with a mean age of 50 years were followed for a mean of 3.8 years ( range 1.6–7.75 ) . All patients had a long duration of painful symptoms ( mean 17.1 months ) from chronic Achilles tendinosis before treatment . At follow up , 22 of 25 patients were satisfied with treatment and active in Achilles tendon loading activities at the desired level . Ultrasonography showed that tendon thickness ( at the widest part ) had decreased significantly ( p<0.005 ) after treatment ( 7.6 ( 2.3 ) v 8.8 ( 3 ) mm ; mean ( SD ) ) . In untreated normal tendons , there was no significant difference in thickness after treatment ( 5.3 ( 1.3 ) mm before and 5.9 ( 0.8 ) mm after ) . All tendons with tendinosis had structural abnormalities ( hypoechoic areas and irregular structure ) before the start of treatment . After treatment , the structure was normal in 19 of the 26 tendons . Six of the seven patients with remaining structural abnormalities experienced pain in the tendon during loading . Conclusions : Ultrasonographic follow up of patients with mid-portion painful chronic Achilles tendinosis treated with eccentric calf muscle training showed a localised decrease in tendon thickness and a normalised tendon structure in most patients . Remaining structural tendon abnormalities seemed to be associated with residual pain in the tendon Background : Controversy exists on stretching and warm-up in injury prevention . We hypothesized that warm up has a greater effect on Achilles tendon biomechanics than static stretching . This study investigated static stretching and warm-up on Achilles tendon biomechanics in recreational athletes , in vivo . Material s and Methods : Ten active , healthy subjects , 5 males , 5 females , With a mean age of 22.9 years with no previous Achilles tendon injuries were recruited . Typical stretching and warm-up routines were created . Testing was performed in a r and omized cross-over design . A custom-built dynamometer was utilized to perform controlled isometric plantarflexion . A low profile ultrasound probe was utilized to visualize the musculotendinous junction of the medial gastrocnemius . An eight-camera motion capture system was used to capture ankle motion . Custom software calculated Achilles tendon biomechanics . Results : Achilles tendon force production was consistent . No statistically significant differences were detected in stretch , stiffness , and strain between pre- , post-stretching , and post-warm-up interventions . Conclusion : Stretching or warm-up alone , and combined did not demonstrate statistically significant differences . Stretching and warm-up may have an equivalent effect on Achilles tendon biomechanics . Prolonged and more intense protocol s may be required for changes to occur . Clinical Relevance : Stretching and warm-up of the Achilles before exercise are commonly practice d. Investigating the effect of stretching and warm-up may shed light on potential injury prevention PURPOSE Many studies have been undertaken to define the effects of static and ballistic stretching . However , most research ers have focused their attention on joint range-of-motion measures . The objective of the present study was to investigate whether static- and ballistic-stretching programs had different effects on passive resistive torque measured during isokinetic passive motion of the ankle joint and tendon stiffness measured by ultrasound imaging . METHODS Eighty-one healthy subjects were r and omized into three groups : a static-stretch group , a ballistic-stretch group , and a control group . Both stretching groups performed a 6-wk stretching program for the calf muscles . Before and after this period , all subjects were evaluated for ankle range of motion , passive resistive torque of the plantar flexors , and the stiffness of the Achilles tendon . RESULTS The results of the study reveal that the dorsiflexion range of motion was increased significantly in all groups . Static stretching result ed in a significant decrease of the passive resistive torque , but there was no change in Achilles tendon stiffness . In contrast , ballistic stretching had no significant effect on the passive resistive torque of the plantar flexors . However , a significant decrease in stiffness of the Achilles tendon was observed in the ballistic-stretch group . CONCLUSION These findings provide evidence that static and ballistic stretching have different effects on passive resistive torque and tendon stiffness , and both types of stretching should be considered for training and rehabilitation programs We prospect ively studied the effect of heavy-load eccentric calf muscle training in 15 recreational athletes ( 12 men and 3 women ; mean age , 44.3 7.0 years )
Output:
| There is evidence that maximal isometric contractions and prolonged static stretching ( > 5 min ) of the triceps surae complex cause an immediate decrease in AT stiffness , whereas prolonged running and hopping have minimal effect .
Limited but consistent evidence exists , indicating that AT hysteresis is reduced after prolonged static stretching .
Consistent evidence supports a reduction in free AT diameter ( anterior-posterior ) after dynamic ankle exercise , and this change appears most pronounced in the healthy tendon and after eccentric exercise .
The mechanical and morphological properties of the AT in vivo are affected by acute exercise in a mode- and dose-dependent manner .
Transient changes in AT stiffness , hysteresis , and diameter after unaccustomed exercise modes and doses may expose the tendon to increased risk of strain injury and impact on the mechanical function of the triceps surae muscle-tendon unit |
MS213217 | ***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 — It is often thought that elderly patients in particular would benefit from endovascular aneurysm treatment . The aim of this analysis was therefore to compare the efficacy and safety of endovascular coiling ( EVT ) with neurosurgical clipping ( NST ) in the subgroup of elderly SAH patients in the International Subarachnoid Aneurysm Trial ( ISAT ) . Methods — In the ISAT cohort 278 SAH patients , 65 years or older , were enrolled . The patients were r and omly allocated EVT ( n=138 ) or NST ( n=140 ) . The primary outcome was the proportion of patients with a modified Rankin scale score of 0 to 2 ( independent survival ) at 1 year after the SAH . The rates of procedural complications and adverse events were also recorded . Results — 83 of 138 ( 60.1 % ) patients allocated EVT were independent compared to 78 of 140 ( 56.1 % ) allocated NST ( N.S. ) . 36 of 50 ( 72.0 % ) patients with internal carotid and posterior communicating artery aneurysms allocated EVT were independent compared to 26 of 50 ( 52.0 % ) allocated NST ( P<0.05 ) . 10 of 22 ( 45.5 % ) patients with middle cerebral artery aneurysms allocated EVT were independent compared to 13 of 15 ( 86.7 % ) allocated NST ( P<0.05 ) . The epilepsy frequency was 0.7 % in the EVT group compared to 12.9 % in the NST group ( P<0.001 ) . Conclusions — In good grade elderly SAH patients with small anterior circulation aneurysms , EVT should probably be the favored treatment for ruptured internal carotid and posterior communicating artery aneurysms , whereas elderly patients with ruptured middle cerebral artery aneurysms appear to benefit from NST . EVT result ed in a lower epilepsy frequency than NST We retrospectively performed stepwise logistic regression analysis on 1,509 patients with chronic heart failure in 4 multicenter United States studies and 1 Australia-New Zeal and study to examine the effect of digoxin in patients r and omized to carvedilol or placebo . Patients receiving digoxin had more advanced heart failure , the incidence of hospitalization for any cause and the combination of all-cause death and all-cause hospitalization were the same in the digoxin versus no-digoxin groups AIMS To determine the effects of digoxin on all-cause mortality and heart failure ( HF ) hospitalizations , regardless of ejection fraction , accounting for serum digoxin concentration ( SDC ) . METHODS AND RESULTS This comprehensive post-hoc analysis of the r and omized controlled Digitalis Investigation Group trial ( n=7788 ) focuses on 5548 patients : 1687 with SDC , drawn r and omly at 1 month , and 3861 placebo patients , alive at 1 month . Overall , 33 % died and 31 % had HF hospitalizations during a 40-month median follow-up . Compared with placebo , SDC 0.5 - 0.9 ng/mL was associated with lower mortality [ 29 vs. 33 % placebo ; adjusted hazard ratio ( AHR ) , 0.77 ; 95 % confidence interval ( CI ) , 0.67 - 0.89 ] , all-cause hospitalizations ( 64 vs. 67 % placebo ; AHR , 0.85 ; 95 % CI , 0.78 - 0.92 ) and HF hospitalizations ( 23 vs. 33 % placebo ; AHR , 0.62 ; 95 % CI , 0.54 - 0.72 ) . SDC > or = 1.0 ng/mL was associated with lower HF hospitalizations ( 29 vs. 33 % placebo ; AHR , 0.68 ; 95 % CI , 0.59 - 0.79 ) , without any effect on mortality . SDC 0.5 - 0.9 reduced mortality in a wide spectrum of HF patients and had no interaction with ejection fraction > 45 % ( P=0.834 ) or sex ( P=0.917 ) . CONCLUSIONS Digoxin at SDC 0.5 - 0.9 ng/mL reduces mortality and hospitalizations in all HF patients , including those with preserved systolic function . At higher SDC , digoxin reduces HF hospitalization but has no effect on mortality or all-cause hospitalizations Objectives This study aims to assess whether digoxin has a different effect on mortality risk for women than it does for men in patients with heart failure ( HF ) . Design This study uses the UK-based The Health Information Network population data base in a cohort study of the impact of digoxin exposure on mortality for men and women who carry the diagnosis of HF . Digoxin exposure was assessed based on prescribing data . Multivariable Cox proportional hazards models were used to assess whether there was an interaction between sex and digoxin affecting mortality hazard . Setting The setting was primary care outpatient practice s. Participants The study cohort consisted of 17 707 men and 19 227 women with the diagnosis of HF who contributed only time without digoxin exposure and 9487 men and 10 808 women with the diagnosis of HF who contributed time with digoxin exposure . Main outcome measures The main outcome measure was all-cause mortality . Results The primary outcome of this study was the absence of a large interaction between digoxin use and sex affecting mortality . For men , digoxin use was associated with a HR for mortality of 1.00 , while for women , the HR was also 1.00 ( p value for interaction 0.65 ) . The results of sensitivity analyses were consistent with those of the primary analysis . Conclusion Observational data do not support the concern that there is a substantial increased risk of mortality due to the use of digoxin in women . This finding is consistent with previous observational studies but discordant with results from a post hoc analysis of a r and omised controlled trial of digoxin versus placebo The propensity score is the probability of treatment assignment conditional on observed baseline characteristics . The propensity score allows one to design and analyze an observational ( nonr and omized ) study so that it mimics some of the particular characteristics of a r and omized controlled trial . In particular , the propensity score is a balancing score : conditional on the propensity score , the distribution of observed baseline covariates will be similar between treated and untreated subjects . I describe 4 different propensity score methods : matching on the propensity score , stratification on the propensity score , inverse probability of treatment weighting using the propensity score , and covariate adjustment using the propensity score . I describe balance diagnostics for examining whether the propensity score model has been adequately specified . Furthermore , I discuss differences between regression-based methods and propensity score-based methods for the analysis of observational data . I describe different causal average treatment effects and their relationship with propensity score analyses Background — There is a paucity of international data on the various types of atrial fibrillation ( AF ) outside the highly selected population s from r and omized trials . This study aim ed to describe patient characteristics , risk factors , comorbidities , symptoms , management strategy , and control of different types of AF in real-life practice . Methods and Results — Real-life global survey evaluating patients with atrial fibrillation ( RealiseAF ) was a contemporary , large-scale , cross-sectional international survey of patients with AF who had ≥1 episode in the past 12 months . Investigators were r and omly selected to avoid bias . Among 9816 eligible patients from 831 sites in 26 countries , 2606 ( 26.5 % ) had paroxysmal , 2341 ( 23.8 % ) had persistent , and 4869 ( 49.6 % ) had permanent AF . As AF progressed from paroxysmal to persistent and permanent forms , the prevalence of comorbidities , such as heart failure ( 32.9 % , 44.3 % , and 55.6 % ) , coronary artery disease ( 30.0 % , 32.9 % , and 34.3 % ) , cerebrovascular disease ( 11.7 % , 10.8 % , and 17.6 % ) , and valvular disease ( 16.7 % , 21.2 % , and 35.8 % ) , increased , and the prevalence of lone AF decreased . Similarly , there was an increase in mean CHADS2 [ cardiac failure , hypertension , age , diabetes , stroke ( doubled ) ] score ( 1.7 , 1.8 , and 2.2 ) , and more than half of patients ( 51.0 % , 56.7 % , and 67.3 % ) qualified for oral anticoagulants . Almost 90 % of patients received ≥1 antiarrhythmic drug , but > 60 % had European Heart Rhythm Association symptom scores from II to IV . Furthermore , 40.7 % of persistent and 49.8 % of permanent AF patients were still in AF with a heart rate > 80 beats per minute . Conclusions — This survey disclosed high cardiovascular risks and an unmet need in daily practice for patients with any type of AF , especially those with the permanent form BACKGROUND The Atrial Fibrillation Follow-up Investigation of Rhythm Management trial showed that digoxin was associated with increased mortality in patients with atrial fibrillation . OBJECTIVES To assess the association of digoxin with cardiovascular ( CV ) morbidity and mortality in patients with permanent atrial fibrillation enrolled in the Dutch Rate Control Efficacy in Permanent AF : A Comparison Between Lenient Versus Strict Rate Control II trial as well as to assess the role of digoxin to achieve heart rate targets . METHODS The primary outcome was a composite of CV morbidity and mortality . Secondary outcomes included CV hospitalization and all-cause mortality or heart failure ( HF ) hospitalization . Of the 614 patients , 608 ( 99 % ) completed the dose-adjustment phase . Outcome events were analyzed from the end of the dose-adjustment phase until the end of follow-up . The median follow-up period was 2.9 years ( interquartile range 2.7 - 3.0 years ) . RESULTS In total , 284 patients ( 46.7 % ) used digoxin after the dose-adjustment phase ( median dosage 0.250 mg ; interquartile range 0.0625 - 0.750 mg ) . These patients were more often women , previously admitted for HF , had an increased left ventricular end-systolic diameter , and more often r and omized to strict rate control . By using Cox proportional hazards regression analysis , the use of digoxin was not associated with an increased risk for the primary and secondary outcomes . For the primary outcome , the 3-year estimated cumulative incidence was 12.9 % vs 13.4 % in the digoxin group vs the no-digoxin group ( unadjusted hazard ratio [ HR ] 0.97 ; 95 % confidence interval [ CI ] 0.62 - 1.52 ) . Incidence was 19.4 % vs. 19.5 % for CV hospitalization ( unadjusted HR 1.00 ; 95 % CI 0.69 - 1.45 ) and 6.6 % vs. 9.9 % for all-cause mortality or HF hospitalization ( unadjusted HR 0.62 ; 95 % CI 0.34 - 1.13 ) in the digoxin group vs the no-digoxin group . CONCLUSION The use of digoxin was not associated with increased morbidity and mortality Increased mortality in digoxin-treated subjects has been demonstrated in patients with recent myocardial infa rct ion . Those with congestive heart failure ( CHF ) due to causes other than myocardial infa rct ion seem to be free from this effect . No information is currently available concerning mortality in elderly people who are frequently prescribed digitalis even in the absence of CHF . The aim of this study was to investigate whether subjects improperly receiving digoxin were worse off than those not receiving this drug . This analysis is a part of CASTEL , a population -based prospect i ve study that has enrolled a cohort of 2,254 subjects aged > or = 65 years . CHF was diagnosed in 187 subjects and atrial fibrillation ( AF ) in 90 . The remaining 1,977 were free from CHF and in sinus rhythm , but 447 were treated with digitalis . Cumulative mortality and morbid events by digitalis treatment were calculated in all these categories . Among subjects free from CHF and AF ( improper use ) , all-cause and cardiovascular mortality was significantly higher among those taking digitalis than in those who did not . Non-fatal events including CHF were also more apparent in the former than in the latter . Cox analysis confirmed digitalis as a predictor of mortality in these subjects . No effect of digitalis on survival was found in patients with CHF or AF ( proper use ) . In elderly subjects without atrial fibrillation or CHF , the use of digitalis worsens morbidity and mortality To determine whether treatment with digitalis is associated with decreased survival after acute myocardial infa rct ion ( AMI ) , data from 504 patients who were enrolled in a postinfa rct ion natural history study were analyzed . At the time of discharge , 229 patients ( 45 % ) were taking digitalis . After 3 years of follow-up , the cumulative survival rate for patients discharged on a regimen of digitalis was 66 % , compared with 87 % for those not treated ( p less than 0.001 ) . Univariate analysis showed that statistically significant
Output:
| Conclusions Digoxin is associated with a neutral effect on mortality in r and omised trials and a lower rate of admissions to hospital across all study types . |
MS213218 | ***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 assess the efficacy of an innovative smoking cessation intervention targeted to a multiethnic , economically disadvantaged HIV-positive population . Design : A two-group r and omized clinical trial compared a smoking cessation intervention delivered by cellular telephone with usual care approach . Methods : Current smokers from a large , inner city HIV/AIDS care center were recruited and r and omized to receive either usual care or a cellular telephone intervention . The usual care group received brief physician advice to quit smoking , targeted self-help written material s and nicotine replacement therapy . The cellular telephone intervention received eight counseling sessions delivered via cellular telephone in addition to the usual care components . Smoking-related outcomes were assessed at a 3-month follow-up . Results : The trial had 95 participants and 77 ( 81.0 % ) completed the 3-month follow-up assessment . Analyses indicated biochemically verified point prevalence smoking abstinence rates of 10.3 % for the usual care group and 36.8 % for the cellular telephone group ; participants who received the cellular telephone intervention were 3.6 times ( 95 % confidence interval , 1.3 - 9.9 ) more likely to quit smoking compared with participants who received usual care ( P = 0.0059 ) . Conclusions : These results suggest that individuals living with HIV/AIDS are receptive to , and can be helped by , smoking cessation treatment . In addition , smoking cessation treatment tailored to the special needs of individuals living with HIV/AIDS , such as counseling delivered by cellular telephone , can significantly increase smoking abstinence rates over that achieved by usual care AIMS To assess Sweet Talk , a text-messaging support system design ed to enhance self-efficacy , facilitate uptake of intensive insulin therapy and improve glycaemic control in paediatric patients with Type 1 diabetes . METHODS One hundred and twenty-six patients fulfilled the eligibility criteria ; Type 1 diabetes for > 1 year , on conventional insulin therapy , aged 8 - 18 years . Ninety-two patients were r and omized to conventional insulin therapy ( n = 28 ) , conventional therapy and Sweet Talk ( n = 33 ) or intensive insulin therapy and Sweet Talk ( n = 31 ) . Goal - setting at clinic visits was reinforced by daily text-messages from the Sweet Talk software system , containing personalized goal -specific prompts and messages tailored to patients ' age , sex and insulin regimen . RESULTS HbA(1c ) did not change in patients on conventional therapy without or with Sweet Talk ( 10.3 + /- 1.7 vs. 10.1 + /- 1.7 % ) , but improved in patients r and omized to intensive therapy and Sweet Talk ( 9.2 + /- 2.2 % , 95 % CI -1.9 , -0.5 , P < 0.001 ) . Sweet Talk was associated with improvement in diabetes self-efficacy ( conventional therapy 56.0 + /- 13.7 , conventional therapy plus Sweet Talk 62.1 + /- 6.6 , 95 % CI + 2.6 , + 7.5 , P = 0.003 ) and self-reported adherence ( conventional therapy 70.4 + /- 20.0 , conventional therapy plus Sweet Talk 77.2 + /- 16.1 , 95 % CI + 0.4 , + 17.4 , P = 0.042 ) . When surveyed , 82 % of patients felt that Sweet Talk had improved their diabetes self-management and 90 % wanted to continue receiving messages . CONCLUSIONS Sweet Talk was associated with improved self-efficacy and adherence ; engaging a classically difficult to reach group of young people . While Sweet Talk alone did not improve glycaemic control , it may have had a role in supporting the introduction of intensive insulin therapy . Scheduled , tailored text messaging offers an innovative means of supporting adolescents with diabetes and could be adapted for other health-care setting s and chronic diseases Background The Internet has potential as a medium for health behavior change programs , but no controlled studies have yet evaluated the impact of a fully automated physical activity intervention over several months with real-time objective feedback from a monitor . Objective The aim was to evaluate the impact of a physical activity program based on the Internet and mobile phone technology provided to individuals for 9 weeks . Methods A single-center , r and omized , stratified controlled trial was conducted from September to December 2005 in Bedfordshire , United Kingdom , with 77 healthy adults whose mean age was 40.4 years ( SD = 7.6 ) and mean body mass index was 26.3 ( SD = 3.4 ) . Participants were r and omized to a test group that had access to an Internet and mobile phone – based physical activity program ( n = 47 ) or to a control group ( n = 30 ) that received no support . The test group received tailored solutions for perceived barriers , a schedule to plan weekly exercise sessions with mobile phone and email reminders , a message board to share their experiences with others , and feedback on their level of physical activity . Both groups were issued a wrist-worn accelerometer to monitor their level of physical activity ; only the test group received real-time feedback via the Internet . The main outcome measures were accelerometer data and self-report of physical activity . Results At the end of the study period , the test group reported a significantly greater increase over baseline than did the control group for perceived control ( P < .001 ) and intention/expectation to exercise ( P < .001 ) . Intent-to-treat analyses of both the accelerometer data ( P = .02 ) and leisure time self-report data ( P = .03 ) found a higher level of moderate physical activity in the test group . The average increase ( over the control group ) in accelerometer-measured moderate physical activity was 2 h 18 min per week . The test group also lost more percent body fat than the control group ( test group : −2.18 , SD = 0.59 ; control group : −0.17 , SD = 0.81 ; P = .04 ) . Conclusions A fully automated Internet and mobile phone – based motivation and action support system can significantly increase and maintain the level of physical activity in healthy adults Background : Ethnic minorities or those with low socioeconomic status ( SES ) are at increased risk of cardiovascular disease , type 2 diabetes , and all-cause mortality , compared to higher SES Whites . National surveys also indicate that low-income , ethnic minority women have the highest rates of inactivity in the United States . Purpose : This study ( the Increasing Motivation for Physical ACTivity or IMPACT study ) promoted adoption and maintenance of physical activity ( PA ) in sedentary , low-income women participating in federally funded job training programs . Methods : The study consisted of 2 months of weekly 1-hr classes , then r and om assignment to 10 months of either home-based telephone counseling for PA plus information and feedback via mailed newsletters ( Phone + Mail Counseling condition ) or just the mailed newsletters ( Mail Support condition ) . The IMPACT intervention included behavior change strategies for PA as well as discussion s related to motivational readiness for PA change . Participants completed surveys and physiological assessment s at baseline after the classes ended ( i.e. , at 10 weeks ) and at 6 and 12 months postbaseline . Seventy-three percent of r and omized participants ( n = 72 ) were Latina , with a mean age of 32 ± 10 years . More than half the women had not completed high school , and 73 % had an annual income less than $ 20,000 . Results : After 10 months of a homebased intervention , women in the phone + mail counseling condition had significantly greater increases in estimated total energy expenditure compared to women in the mail support condition ( p < .05 ) . Conclusions : Regular PA counseling delivered via the telephone and through the mail appears effective for encouraging regular PA among low-income women transitioning from welfare or job training to the workforce AIMS To assess the long-term efficacy of a fully automated digital multi-media smoking cessation intervention . DESIGN Two-arm r and omized control trial ( RCT ) . Setting World Wide Web ( WWW ) study based in Norway . PARTICIPANTS Subjects ( n = 396 ) were recruited via internet advertisements and assigned r and omly to conditions . Inclusion criteria were willingness to quit smoking and being aged 18 years or older . INTERVENTION The treatment group received the internet- and cell-phone-based Happy Ending intervention . The intervention programme lasted 54 weeks and consisted of more than 400 contacts by e-mail , web-pages , interactive voice response ( IVR ) and short message service ( SMS ) technology . The control group received a self-help booklet . Additionally , both groups were offered free nicotine replacement therapy ( NRT ) . MEASUREMENTS Abstinence was defined as ' not even a puff of smoke , for the last 7 days ' , and assessed by means of internet surveys or telephone interviews . The main outcome was repeated point abstinence at 1 , 3 , 6 and 12 months following cessation . FINDINGS Participants in the treatment group reported clinical ly and statistically significantly higher repeated point abstinence rates than control participants [ 22.3 % versus 13.1 % ; odds ratio ( OR ) = 1.91 , 95 % confidence interval ( CI ) : 1.12 - 3.26 , P = 0.02 ; intent-to-treat ) . Improved adherence to NRT and a higher level of post-cessation self-efficacy were observed in the treatment group compared with the control group . CONCLUSIONS As the first RCT documenting the long-term treatment effects of such an intervention , this study adds to the promise of digital media in supporting behaviour change Objectives : To determine the effectiveness of a mobile phone text messaging smoking cessation programme . Design : R and omised controlled trial Setting : New Zeal and Participants : 1705 smokers from throughout New Zeal and who wanted to quit , were aged over 15 years , and owned a mobile phone were r and omised to an intervention group that received regular , personalised text messages providing smoking cessation advice , support , and distraction , or to a control group . All participants received a free month of text messaging ; starting for the intervention group on their quit day to assist with quitting , and starting for the control group at six months to encourage follow up . Follow up data were available for 1624 ( 95 % ) at six weeks and 1265 ( 74 % ) at six months . Main outcome measures : The main trial outcome was current non-smoking ( that is , not smoking in the past week ) six weeks after r and omisation . Secondary outcomes included current non-smoking at 12 and 26 weeks . Results : More participants had quit at six weeks in the intervention compared to the control group : 239 ( 28 % ) v 109 ( 13 % ) , relative risk 2.20 ( 95 % confidence interval 1.79 to 2.70 ) , p < 0.0001 . This treatment effect was consistent across subgroups defined by age , sex , income level , or geographic location ( p homogeneity > 0.2 ) . The relative risk estimates were similar in sensitivity analyses adjusting for missing data and salivary cotinine verification tests . Reported quit rates remained high at six months , but there was some uncertainty about between group differences because of incomplete follow up . Conclusions : This programme offers potential for a new way to help young smokers to quit , being affordable , personalised , age appropriate , and not location dependent . Future research should test these findings in different setting s , and provide further assessment of long term quit rates AIMS There is increasing international interest in using emerging technologies to enhance chronic disease management . We aim ed to explore the attitudes of patients and primary care professionals to using mobile technology in order to monitor asthma . METHODS A piloted question naire containing closed and open-ended questions assessing attitudes to using electronic self-monitoring was posted to a r and om sample of general practitioners , asthma nurses , and people with asthma ( 12 years and over ) in Lothian and Kent , UK , with 2 reminders . In addition to descriptive statistics , patient and clinician responses were compared using Chi-squared or independent sample t-tests . Free-text responses were analysed thematically . RESULTS Responses were obtained from 130/300 professionals ( 43 % ) and 202/389 patients ( 52 % ) . Patients rated the technology positively and considered that it may help clinicians to provide care , especially during acute attacks . Although rated similarly , professionals were more sceptical about benefits . Both professionals and patients had concerns about the time and cost implication s. Of the respondents , 28 professionals ( 10 % ) and 62 patients ( 16 % ) returned uncompleted question naires citing lack of perceived relevance . CONCLUSIONS The low completion rate probably reflects the current status of mobile phone-facilitated care as a minority interest for ' early adopters ' of technology . Even for the enthusiastic minority , using mobile phone technology raised questions of clinical benefit , impact on self-management , and concerns about workload and cost , which will need to be addressed prior to wider acceptance AIM To investigate the effectiveness of a nurse short message service ( SMS ) by cellular phone and wire Internet on plasma glucose levels in people with diabetes for six months . BACKGROUND Blood glucose management system using telemedicine approaches may maintain the appropriate blood glucose levels in type-2 diabetic patients . DESIGN A control group pre-test-post-test design was used to assess the effectiveness of nurse 's education . METHODS Twenty-five patients were r and omly assigned to an intervention group and 26 to a control group . The intervention
Output:
| Significant improvements were noted in compliance with medicine taking , asthma symptoms , HbA1C , stress levels , smoking quit rates , and self-efficacy .
Process improvements were reported in lower failed appointments , quicker diagnosis and treatment , and improved teaching and training . |
MS213219 | ***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 assessed the effect of a h and held computer-based decision support system ( DSS ) on antibiotic use and patient outcomes in a critical care unit . DESIGN A DSS containing four types of evidence ( patient microbiology reports , local antibiotic guidelines , unit-specific antibiotic susceptibility data for common bacterial pathogens , and a clinical pulmonary infection score calculator ) was developed and implemented on a h and held computer for use in the intensive care unit at a tertiary referral hospital . System impact was assessed in a prospect i ve " before/after " cohort trial lasting 12 months . Outcome measures were defined daily doses ( DDDs ) of antibiotics per 1,000 patient-days , patient length of stay , and mortality . RESULTS The number of admissions , APACHE ( Acute Physiology , Age , and Chronic Health Evaluation ) II and SAPS ( Simplified Acute Physiology Score ) II for patients in preintervention , and intervention ( DSS use ) periods were statistically comparable . The mean patient length of stay and the use of antibiotics in the unit during six months of the DSS use decreased from 7.15 to 6.22 bed-days ( p = 0.02 ) and from 1,767 DDD to 1,458 DDD per 1,000 patient-days ( p = 0.04 ) , respectively , with no change in mortality . The DSS was accessed 674 times during 168 days of the trial . Microbiology reports and antibiotic guidelines were the two most commonly used ( 53 % and 22.5 % , respectively ) types of evidence . The greatest reduction was observed in the use of beta-lactamase-resistant penicillins and vancomycin . CONCLUSION H and held computer-based decision support contributed to a significant reduction in patient length of stay and antibiotic prescribing in a critical care unit A prospect i ve quasi-experimental study was undertaken in 218 patients with suspicion of nosocomial infection hospitalized in a polyvalent ICU where a new electronic device ( GERB ) has been design ed for antibiotic prescriptions . Two GERB-based applications were developed to provide local resistance maps ( LRMs ) and preliminary microbiological reports with therapeutic recommendation ( PMRTRs ) . Both applications used the data in the Laboratory Information System of the Microbiology Department to report on the optimal empiric therapeutic option , based on the most likely susceptibility profile of the microorganisms potentially responsible for infection in patients and taking into account the local epidemiology of the hospital department/unit . LRMs were used for antibiotic prescription in 20.2 % of the patients and PMRTRs in 78.2 % , and active antibiotics against the finally identified bacteria were prescribed in 80.0 % of the former group and 82.4 % of the latter . When neither LMRs nor PMRTRs were considered for empiric treatment prescription , only around 40 % of the antibiotics prescribed were active . Hence , the percentage appropriateness of the empiric antibiotic treatments was significantly higher when LRM or PMRTR guidelines were followed rather than other criteria . LRMs and PMRTRs applications are dynamic , highly accessible , and readily interpreted instruments that contribute to the appropriateness of empiric antibiotic treatments OBJECTIVE Computerized medical decision support tools have been shown to improve the quality of care and have been cited by the Institute of Medicine as one method to reduce pharmaceutical errors . We evaluated the impact of an antiinfective decision support tool in a pediatric intensive care unit ( PICU ) . METHODS We enhanced an existing adult antiinfective management tool by adding and changing medical logic to make it appropriate for pediatric patients . Process and outcomes measures were monitored prospect ively during a 6-month control and a 6-month intervention period . M and atory use of the decision support tool was initiated for all antiinfective orders in a 26-bed PICU during the intervention period . Clinician opinions of the decision support tool were surveyed via question naire . RESULTS The rate of pharmacy interventions for erroneous drug doses declined by 59 % . The rate of anti-infective subtherapeutic patient days decreased by 36 % , and the rate of excessive-dose days declined by 28 % . The number of orders placed per antiinfective course decreased 11.5 % , and the robust estimate of the antiinfective costs per patient decreased 9 % . The type of anti-infectives ordered and the number of antiinfective doses per patient remained similar , as did the rates of adverse drug events and antibiotic-bacterial susceptibility mismatches . The surveyed clinicians reported that use of the program improved their antiinfective agent choices as well as their awareness of impairments in renal function and reduced the likelihood of adverse drug events . CONCLUSIONS Use of the pediatric antiinfective decision support tool in a PICU was considered beneficial to patient care by the clinicians and reduced the rates of erroneous drug orders , improved therapeutic dosage targets , and was associated with a decreased robust estimate of antiinfective costs per patient . antiinfective agents , decision support systems , drug therapy , medication errors , child , infant The objective of this prospect i ve clinical usage study was to examine the value of the rule based ' Therapeutic Assistant ' integrated into an existing Patient Data Management System ( PDMS ) in helping to prescribe a initial antibiotic regime in accordance with the requirements of accepted guidelines . A prospect i ve study comparing data before and after the introduction of the ' Therapeutic Assistant ' was carried out . An adequate therapy result ed significantly more often after the introduction of the ' Therapeutic Assistant ' [ p<0.05 ] ; however no difference between the regimes with and without the ' Therapeutic Assistant ' in the period after its introduction could be established . Whether the ' Therapeutic Assistant ' influenced the prescriptions made without it will have to be established in a further study Objective : To evaluate the hospital-wide impact of a st and ardized order set for the management of bacteremic severe sepsis on processes of medical care and patient outcomes . Design : Retrospective , before and after study design . Setting : Barnes-Jewish Hospital , a 1200-bed academic medical center . Patients : Bacteremic patients with severe sepsis ( 200 from the 18-month before period and 200 from the 18-month after period ) . Interventions : Hospital-wide implementation of a st and ardized order set for the management of bacteremic severe sepsis . Measurements and Main Results : A total of 400 patients with bacteremia and severe sepsis were selected at r and om within the specified time periods . Patients in the after group received more intravenous fluids in the first 12 hours after onset of hypotension ( 1627 ± 1862 mL vs. 2054 ± 2237 mL ; p = 0.04 ) and were more likely to receive appropriate initial antibiotic therapy ( 53.0 % vs. 65.5 % , p = 0.01 ) . In-hospital mortality was statistically decreased in the after group ( 55.0 % vs. 39.5 % , p < 0.01 ) , as was the hospital length of stay ( 28.7 ± 30.1 days vs. 22.4 ± 20.9 days ; p = 0.02 ) . Compared with the before group , the after group had reduced occurrence of renal failure ( 49.0 % vs. 36.0 % , p < 0.01 ) , cardiovascular failure ( 70.5 % vs. 57.0 % , p < 0.01 ) , and were less likely to require vasopressors after initial fluid resuscitation ( 68.5 % vs. 52.5 % , p < 0.01 ) . Conclusions : The implementation of a hospital-wide st and ardized order set for the management of bacteremic severe sepsis was associated with greater fluid administration , improved antibiotic therapy , decreased incidence of organ failure , and improved survival OBJECTIVE Antibiotic computerized decision support systems ( CDSSs ) were developed to guide antibiotic decisions , yet prescriptions of CDSS-recommended antibiotics have remained low . Our aim was to identify predictors of patients ' receipt of empiric antibiotic therapies recommended by a CDSS when the prescribing physician had an initial preference for using broad-spectrum antibiotics . METHODS We conducted a prospect i ve cohort study in a 1 500-bed tertiary-care hospital in Singapore . We included all patients admitted from October 1 , 2011 through September 30 , 2012 , who were prescribed piperacillin-tazobactam or carbapenem for empiric therapy and auto-triggered to receive antibiotic recommendations by the in-house antibiotic CDSS . Relevant data on the patient , prescribing and attending physicians were collected via electronic linkages of medical records and administrative data bases . To account for clustering , we used multilevel logistic regression models to explore factors associated with receipt of CDSS-recommended antibiotic therapy . RESULTS One-quarter of the 1 886 patients received CDSS-recommended antibiotics . More patients treated for pneumonia ( 33.2 % ) than sepsis ( 12.1 % ) and urinary tract infections ( 7.1 % ) received CDSS-recommended antibiotic therapies . The prescribing physician - but not the attending physician or clinical specialty - accounted for some ( 13.3 % ) of the variation . Prior hospitalization ( odds ratio [ OR ] 1.32 , 95 % CI , 1.01 - 1.71 ) , presumed pneumonia ( OR 6.77 , 95 % CI , 3.28 - 13.99 ) , intensive care unit ( ICU ) admission ( OR 0.38 , 95 % CI , 0.21 - 0.66 ) , and renal impairment ( OR 0.70 , 95 % CI , 0.52 - 0.93 ) were factors associated with patients ' receipt of CDSS-recommended antibiotic therapies . CONCLUSIONS We observed that ICU admission and renal impairment were negative predictors of patients ' receipt of CDSS-recommended antibiotic therapies . Patients admitted to ICU and those with renal impairment might have more complex clinical conditions that require a physician 's assessment in addition to antibiotic CDSS Electronic clinical decision support systems ( CDSS ) have been hailed for their potential to improve clinical outcomes . Using a pretest/posttest design , an Internet-based CDSS design ed to optimize antimicrobial prescribing was pilot tested for community-acquired pneumonia in 5 rural hospitals in southwestern Idaho . An antimicrobial management team was created in each hospital to address clinicians ’ perception of excessive time required for direct use of the CDSS . In pooled hospital data , agreement with CDSS recommendations improved to a statistically significant level . However , inspection of data at the individual hospital level demonstrated that almost all improvement occurred in a single hospital . Failure in the other hospitals appeared to be primarily a consequence of organizational and cultural barriers . These barriers are discussed to underst and keys for successful future implementation of CDSS in rural hospitals , drawing on experience with cultural barriers from other industries , specifically aviation OBJECTIVES Antibiotic stewardship is important , but the ideal strategy for providing stewardship in a hospital setting is unknown . A practical , sustainable and transferable strategy is needed . This study evaluates the impact of a novel computerized antimicrobial approval system on antibiotic-prescribing behaviour in a hospital . Effects on drug consumption , antibiotic resistance patterns of local bacteria and patient outcomes were monitored . METHODS The study was conducted at a tertiary referral teaching hospital in Melbourne , Australia . The system was deployed in January 2005 and guided the use of 28 restricted antimicrobials . Data were collected over 7 years : 5 years before and 2 years after deployment . Uptake of the system was evaluated using an in-built audit trail . Drug utilization was prospect ively monitored using pharmacy data ( as defined daily doses per 1000 bed-days ) and analysed via time-series analysis with segmental linear regression . Antibiograms of local bacteria were prospect ively evaluated . In-hospital mortality and length of stay for patients with Gram-negative bacteraemia were also reported . RESULTS Between 250 and 300 approvals were registered per month during 2006 . The gradients in the use of third- and fourth-generation cephalosporins ( + 0.52 , -0.05 , -0.39 ; P < 0.01 ) , glycopeptides ( + 0.27 , -0.53 ; P = 0.09 ) , carbapenems ( + 0.12 , -0.24 ; P = 0.21 ) , aminoglycosides ( + 0.15 , -0.27 ; P < 0.01 ) and quinolones ( + 0.76 , + 0.11 ; P = 0.08 ) all fell after deployment , while extended-spectrum penicillin use increased . Trends in increased susceptibility of Staphylococcus aureus to methicillin and improved susceptibility of Pseudomonas spp . to many antibiotics were observed . No increase in adverse outcomes for patients with Gram-negative bacteraemia was observed . CONCLUSIONS The system was successfully adopted and significant changes in antimicrobial usage were demonstrated STUDY OBJECTIVE Despite evidence that guideline adherence improves clinical outcomes , management of pneumonia patients varies in emergency departments ( EDs
Output:
| CDS was associated with lower antibiotic utilisation , increased compliance with antibiotic guidelines and reductions in antimicrobial resistance .
Conflicting effects of CDS on length of stay , antibiotic costs and system uptake were also noted .
CDS has the potential to improve the adequacy of antibiotic coverage and marginally decrease mortality in hospital-related setting |
MS213220 | ***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: CONTEXT Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions . OBJECTIVE To explore whether the association between funding and conclusions in r and omized drug trials reflects treatment effects or adverse events . DESIGN Observational study of 370 r and omized drug trials included in meta-analyses from Cochrane review s selected from the Cochrane Library , May 2001 . From a r and om sample of 167 Cochrane review s , 25 contained eligible meta-analyses ( assessed a binary outcome ; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment ) . The primary binary outcome from each meta- analysis was considered the primary outcome for all trials included in each meta- analysis . The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect , adverse events , and additional confounding factors ( method ological quality , control intervention , sample size , publication year , and place of publication ) . MAIN OUTCOME MEASURE Conclusions in trials , classified into whether the experimental drug was recommended as the treatment of choice or not . RESULTS The experimental drug was recommended as treatment of choice in 16 % of trials funded by nonprofit organizations , 30 % of trials not reporting funding , 35 % of trials funded by both nonprofit and for-profit organizations , and 51 % of trials funded by for-profit organizations ( P<.001 ; chi2 test ) . Logistic regression analyses indicated that funding , treatment effect , and double blinding were the only significant predictors of conclusions . Adjusted analyses showed that trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice ( odds ratio , 5.3 ; 95 % confidence interval , 2.0 - 14.4 ) compared with trials funded by nonprofit organizations . This association did not appear to reflect treatment effect or adverse events . CONCLUSIONS Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results . Readers should carefully evaluate whether conclusions in r and omized trials are supported by data CONTEXT The Consoli date d St and ards for Reporting of Trials ( CONSORT ) statement was developed to help improve the quality of reports of r and omized controlled trials ( RCTs ) . To date , a paucity of data exists regarding whether it has achieved this goal . OBJECTIVE To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs . DESIGN AND SETTING Comparative before- and -after evaluation in which reports of RCTs published in 1994 ( pre-CONSORT ) were compared with RCT reports from the same journals published in 1998 ( post-CONSORT ) . We included 211 reports from BMJ , JAMA , and The Lancet ( journals that adopted CONSORT ) as well as The New Engl and Journal of Medicine ( a journal that did not adopt CONSORT and was used as a comparator ) . MAIN OUTCOME MEASURES Number of CONSORT items included in a report , frequency of unclear reporting of allocation concealment , and overall trial quality score based on the Jadad scale , a 5-point quality assessment instrument . RESULTS Compared with 1994 , the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998 , and this increase was statistically significant for the 3 adopter journals ( pre-CONSORT , 23.4 ; mean change , 3.7 ; 95 % confidence interval [ CI ] , 2.1 - 5.3 ) . The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals , and this change was statistically significant for adopters ( pre-CONSORT , 61 % ; mean change , -22 % ; 95 % CI , -38 % to -6 % ) . Similarly , 3 of the 4 journals showed an improvement in the quality score for reports of RCTs , and this increase was statistically significant for adopter journals overall ( pre-CONSORT , 2.7 ; mean change , 0.4 ; 95 % CI , 0.1 - 0.8 ) . CONCLUSION Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs UNLABELLED Although two pegylated interferons ( Peg-IFN ) are available to treat chronic hepatitis C virus ( HCV ) infection , no head-to-head comparative studies have been published . We aim to compare the efficacy and safety of PEG IFN alfa-2b ( PEG 2b ) versus PEG IFN alfa-2a ( PEG 2a ) , plus ribavirin ( RBV ) . A prospect i ve , r and omized , multi-center , open-label clinical trial including 182 human immunodeficiency virus (HIV)-hepatitis C virus ( HCV ) patients naïve for HCV therapy was performed . Patients were assigned to PEG 2b ( 80 - 150 mug/week ; n = 96 ) or PEG 2a ( 180 mug/week ; n = 86 ) , plus RBV ( 800 - 1200 mg/day ) for 48 weeks . The primary endpoint was sustained virological response ( SVR : negative HCV-RNA 24 weeks after completion of treatment ) . At baseline , both groups were well balanced : 73 % male ; 63 % HCV genotype 1 or [ corrected ] 4 ; 29 % had fibrosis index of 3 or greater . The overall SVR was 44 % ( 42 % PEG 2b versus 46 % PEG 2a , P = 0.65 ) . Among genotypes 1 or [ corrected ] 4 , SVRs were 28 % versus 32 % ( P = 0.67 ) and 62 % versus 71 % ( P = 0.6 ) in genotypes 2 or [ corrected ] 3 for PEG 2b and PEG 2a , respectively . Early virological response ( EVR ; > or=2 log reduction from baseline or negative HCV-RNA at week 12 ) was 70 % in the PEG 2b group and 80 % in the PEG 2a group ( P = 0.13 ) , reaching a positive predictive value of SVR of 64 % and a negative predictive value of 100 % in both arms . Side effects were present in 96 % of patients but led to treatment discontinuation in 10 % of patients ( 8 % on PEG 2b and 13 % on PEG 2a , P = 0.47 ) . CONCLUSION In patients with HIV , HCV therapy with PEG 2b or PEG 2a plus RBV had no significant differences in efficacy and safety BACKGROUND / AIMS To compare the pharmacokinetics , pharmacodynamics , and antiviral activity of peginterferon alfa-2b and peginterferon alfa-2a in patients with chronic hepatitis C virus genotype 1 . METHODS Thirty-six patients were r and omised to peginterferon alfa-2b ( 1.5 microg/kg/week ) or peginterferon alfa-2a ( 180 microg/week ) for 4 weeks , then in combination with ribavirin ( 13 mg/kg/day ) for a further 4 weeks . The pharmacokinetic profile of both peginterferons , mRNA expression of a selected group of interferon-induced gene transcripts , and serum HCV-RNA levels were assessed . RESULTS Patients receiving peginterferon alfa-2b had significantly greater up-regulation of interferon-alfa response genes compared with those receiving peginterferon alfa-2a . Correspondingly , patients treated with peginterferon alfa-2b also had a significantly greater log10 maximum and log10 time-weighted average decrease in serum HCV-RNA . A greater proportion of peginterferon alfa-2b patients achieved a > or = 2.0 log10 reduction in serum HCV-RNA levels by week 8 ( 72 % vs 44 % of peginterferon alfa-2a patients , P = 0.09 ) . There was an approximately 16-fold greater exposure to peginterferon in the serum of patients treated with peginterferon alfa-2a . CONCLUSIONS These findings suggest that the biological activity , measured by early interferon-induced gene transcripts and early antiviral responsiveness , may have been greater in patients treated with peginterferon alfa-2b despite their lower exposure to the drug compared with patients treated with peginterferon alfa-2a CONTEXT Controversy and uncertainty ensue when the results of clinical research on the effectiveness of interventions are subsequently contradicted . Controversies are most prominent when high-impact research is involved . OBJECTIVES To underst and how frequently highly cited studies are contradicted or find effects that are stronger than in other similar studies and to discern whether specific characteristics are associated with such refutation over time . DESIGN All original clinical research studies published in 3 major general clinical journals or high-impact-factor specialty journals in 1990 - 2003 and cited more than 1000 times in the literature were examined . MAIN OUTCOME MEASURE The results of highly cited articles were compared against subsequent studies of comparable or larger sample size and similar or better controlled design s. The same analysis was also performed comparatively for matched studies that were not so highly cited . RESULTS Of 49 highly cited original clinical research studies , 45 cl aim ed that the intervention was effective . Of these , 7 ( 16 % ) were contradicted by subsequent studies , 7 others ( 16 % ) had found effects that were stronger than those of subsequent studies , 20 ( 44 % ) were replicated , and 11 ( 24 % ) remained largely unchallenged . Five of 6 highly-cited nonr and omized studies had been contradicted or had found stronger effects vs 9 of 39 r and omized controlled trials ( P = .008 ) . Among r and omized trials , studies with contradicted or stronger effects were smaller ( P = .009 ) than replicated or unchallenged studies although there was no statistically significant difference in their early or overall citation impact . Matched control studies did not have a significantly different share of refuted results than highly cited studies , but they included more studies with " negative " results . CONCLUSIONS Contradiction and initially stronger effects are not unusual in highly cited research of clinical interventions and their outcomes . The extent to which high citations may provoke contradictions and vice versa needs more study . Controversies are most common with highly cited nonr and omized studies , but even the most highly cited r and omized trials may be challenged and refuted over time , especially small ones BACKGROUND The efficacy and tolerability of Peg-Interferon alpha-2a ( Peg-IFNalpha-2a ) versus Peg-Interferon alpha-2b ( Peg-IFNalpha-2b ) were compared in a patient cohort with hepatitis C virus (HCV)-related active chronic hepatitis , unresponsive to previous antiviral treatment with st and ard IFN ( 6 MU three times/week ) plus ribavirin ( 10.6 mg/kg/day ) for a period of at least 3 months . PATIENTS AND METHODS A total of 143 patients were enrolled and r and omized into two treatment groups ( A-B ) . Group A ( 71 patients ) received one vial of Peg-IFNalpha-2a weekly ( 180 microg ) subcutaneously whereas Group B ( 72 patients ) received 1.5 microg/kg of Peg-IFNalpha-2b weekly subcutaneously . Interferon was combined with ribavirin ( 15 mg/kg/day ) in both groups and all patients who demonstrated nondetectable HCV-RNA or a > or=2(log ) reduction in viral load at week 12 , were treated for 48 weeks , with a 24-week follow up . RESULTS Group A ( 10/71 ) and Group B ( 8/72 ) patients discontinued treatment due to severe side effects . At the end of therapy , HCV-RNA was undetectable in 17/71 ( 23.9 % ) Group A and in 19/72 ( 26.4 % ) of Group B patients . When terminating follow up , a sustained virological response was observed in 14/71 in Group A ( 19.7 % ) and 13/72 in Group B ( 18.0 % ) . CONCLUSIONS Within the limits of the relatively small sample size , Peg-IFNalpha-2a and Peg-IFNalpha-2b demonstrated nonstatistically significant differences in effectiveness in patients nonresponsive to previous antiviral treatment UNLABELLED The overall mortality of patients infected with hepatitis C virus ( HCV ) has not been fully eluci date d. This study analyzed mortality in subjects positive for antibody to HCV ( anti-HCV ) in a community-based , prospect i ve cohort study conducted in an HCV hyperendemic area of Japan . During a 10-year period beginning in 1995 , 1125 anti-HCV-seropositive residents of Town C were enrolled into the study and were followed for mortality through 2005 . Cause of death was assessed by death certificates . Subjects with detectable HCV core antigen ( HCVcAg ) or HCV RNA were considered as having hepatitis C viremia and were classified as HCV carriers ; subjects who were negative for both HCVcAg and HCV RNA ( i.e. , viremia-negative ) were considered as having had a prior HCV infection and were classified as HCV noncarriers . Among the anti-HCV-positive subjects included in the analysis , 758 ( 67.4 % ) were HCV carriers , and 36
Output:
| Current evidence suggests that peginterferon alpha-2a is associated with higher SVR than peginterferon alfa-2b .
However , the paucity of evidence on adverse events curbs the decision to definitively recommend one peginterferon over the other , because any potential benefit must outweigh the risk of harm |
MS213221 | ***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 . Nowadays , registration of patient data on paper is gradually being replaced by registration using an intensive care information system ( ICIS ) . The aim of this study was to evaluate the effect of the use of an ICIS on nursing activity . Design . R and omized controlled trial with a crossover design . Setting . An 18-bed medical-surgical ICU in a teaching hospital . Patients , nurses and interventions . During a 6week period 145 consecutive adult patients admitted to the ICU after uncomplicated cardiothoracic surgery were r and omized into two groups : for one group the documentation was carried out using a paper-based registration ( Paper ) , in the second group an ICIS was used for documentation . Measurements and results . The nursing activities for these patients were studied during two separate periods : the admission period and the registration phase ( the period directly following the admission procedure ) . The duration of the admission procedure was measured by time-motion analysis and the nursing activities in the registration phase were studied by work sampling methodology . All nursing activities during the registration phase were grouped in four main categories : patient care , documentation , unit-related and personal time . The duration of the admission procedure was longer in the ICIS group ( 18.1±4.1 versus 16.8±3.1 min , p<0.05 ) . In the registration phase , a 30 % reduction in documentation time ( Paper 20.5 % of total nursing time versus ICIS 14.4 % , p<0.001 ) , corresponding to 29 min ( per 8h nursing shift ) was achieved . This time was completely re-allocated to patient care . Conclusions . The use of the present ICIS in patients after cardiothoracic surgery alters nursing activity ; it reduces the time for documentation and increases the time devoted to patient care . Electronic Supplementary Material is available if you access this article at http://dx.org/10.1007/s00134-002-1542-9 . On that page ( frame on the left side ) , a link takes you directly to the supplementary material Objective To determine the percentage of time that intensive care unit ( ICU ) nurses spend on documentation and other nursing activities before and after installation of a third-generation ICU information system . Design Prospect i ve data collection using real-time time-motion analysis , before and after installation of the ICU information system . Setting A ten-bed surgical ICU at a Veterans Affairs medical center . SubjectsICU nurses . Interventions Installation of a third-generation ICU information system . Measurements and Main Results Ten ICU nurses were studied before and after installation of the ICU information system . Each ICU nurse ’s activities and tasks , during 4-hr observation periods , were categorized in real-time by a nurse observer and recorded in a laptop computer . Each recorded task was automatically time-stamped and logged into a data file . The percentage of time spent on documentation decreased from 35.1 ± 8.3 % to 24.2 ± 7.6 % ( p = .025 ) after the ICU information system was installed . The percentage of time providing direct patient care increased from 31.3 ± 9.2 % to 40.1 ± 11.7 % ( p = .085 ) . The percentage of time doing patient assessment , a direct patient care task , increased from 4.0 ± 4.7 % to 9.4 ± 4.4 % ( p = .001 ) . Conclusions Installation of a third-generation ICU information system decreased the percentage of time ICU nurses spent on documentation by > 30 % . Almost half of the time saved on documentation was spent on patient assessment , a direct patient care task Computerized physician order entry ( CPOE ) has been shown to improve quality , and to reduce re source utilization , but most available data suggest that it takes longer to enter orders using CPOE . We had previously implemented a CPOE system , and elected to evaluate its impact on physician time in the new setting . To do this , we performed a prospect i ve study using r and om reminder methodology . Key findings were that interns spent 9.0 % of their time ordering with CPOE , compared to 2.1 % before , although CPOE saved them an additional 2 % of time , so that the net difference was 5 % of their total time . However , this is counterbalanced by decreased time for other personnel such as nursing and pharmacy , and by the quality and efficiency changes . We conclude that while CPOE has many benefits , it represents a major process change , and organizations must factor this in when they implement it This article describes a comparative study that examined the frequencies of nursing activities , when using a clinical information system ( CIS ) and a paper-based documentation system in an Australian intensive care unit . The study unit had half the beds equipped with a CIS , and the remaining beds used paper documentation . Work sampling methodology was used to observe nurses working with both systems . Though there were differences for all activities between the environments and the directions of the differences were logical , none were statistically significant using a chi-square test ( P = .11 - 0.65 ) , probably because of the small sample size . This study established that work sampling methodology using a r and om timer is a valid and relatively easy method to capture work activity in the clinical area . Although this article does not provide definitive information regarding the benefits of a CIS over manual documentation , a number of important method ological issues are discussed , including the study design , procedure , use of dedicated observers , and the distinction between basic versus fully optioned systems . Future research should evaluate the efficiency , impact on patient outcomes and nursing practice , and cost effectiveness of fully optioned systems OBJECTIVE To measure the impact on nursing activity of introducing computerized medical records into intensive care units ( ICUs ) . DESIGN Prospect i ve data collection monitoring the activity of ICU nurses before and after installation of a computerized charting system . SETTING A six-bed coronary care unit and an eight-bed medical ICU at the Minneapolis VA Medical Center . SUBJECTS Registered nurses providing intensive care services . INTERVENTIONS Installation of a Clinical Information System that computerized the ICU medical records . MEASUREMENTS AND MAIN RESULTS Before computer installation , nurses spent 24 % of their time manipulating data ( 7 % gathering and 17 % charting ) . After installation , charting time decreased to 10 % , and data gathering time decreased to 4 % , while 10 % of time was spent at computer terminals entering or review ing data . The total time manipulating data post-installation was thus 24 % ( i.e. , unchanged from previous ) . Computerized charting did not alter time spent in patients ' rooms ( 43 % pre- and 43 % postinstallation ) compared with time spent at the central station ( 37 % pre- and 36 % post-installation ) or elsewhere ( 20 % pre- and 21 % postinstallation ) . Relative time spent at various tasks varied between units and from shift to shift , but the net effect of computerized charting was that nurses had more time available at the central station for monitoring , and that the computer terminals were used primarily in the patient rooms . CONCLUSIONS Computerized charting will not necessarily provide ICU nurses with a net excess of time for tasks unrelated to manipulating data OBJECTIVE To study the effect of an Internet-based personal health record on the empowerment of patients undergoing IVF . DESIGN R and omized clinical trial . SETTING Patients undergoing IVF and intracytoplasmic sperm injection ( ICSI ) in an academic research environment . PATIENT(S ) We selected patients who were undergoing an IVF or ICSI treatment , have an Internet connection , and speak fluent Dutch . INTERVENTION(S ) An Internet-based personal health record that provides patients with general and personal information concerning their given treatment and that also provides facilities for communication with fellow patients and physicians . MAIN OUTCOME MEASURE(S ) Patient empowerment ( measured as a multidimensional concept consisting of self-efficacy , actual and perceived knowledge , and involvement in the decision process ) , patient satisfaction , meaning of infertility problems , social support , anxiety , and depression . RESULT ( S ) A total of 91 female and 89 male participants were suitable for analysis . No significant differences were observed in per person change in patient empowerment . We did not find any significant differences regarding per person change in patient satisfaction , the meaning of infertility problems , social support , anxiety , and depression . CONCLUSION ( S ) Usage of the personal health record did not have any effects on patient empowerment , but , at the same time , the study did not find that the personal health record had any significant adverse effects either The purpose of this project was to study the applicability of pen-based computer technology to home health care through the development of a pen-based computer system for a Hospital/Community-Patient Review Instrument ( H/C-PRI ) used for nursing home placement . The sample included nurses ( n = 12 ) from the four regional Visiting Nurse Service of New York offices , as well as all patients on whom a H/C-PRI was completed during the pre-period ( n = 238 ) and patients on whom a H/C-PRI was completed during the post-period ( n = 238 ) . The quality of documentation was higher for patients whose H/C-PRI was performed using the pen-based computer ( 0 % calculation errors ) than for those patients whose H/C-PRI was documented in the usual manner ( 11 % calculation errors ) BACKGROUND To determine whether a Web-based diabetes case management program based in an electronic medical record can improve glycemic control ( primary outcome ) and diabetes-specific self-efficacy ( secondary outcome ) in adults with type 1 diabetes , a pilot r and omized controlled trial was conducted . METHODS A 12-month r and omized trial tested a Web-based case management program in a diabetes specialty clinic . Patients 21 - 49 years old with type 1 diabetes receiving multiple daily injections with insulin glargine and rapid-acting analogs who had a recent A1C > 7.0 % were eligible for inclusion . Participants were r and omized to receive either ( 1 ) usual care plus the nurse-practitioner-aided Web-based case management program ( intervention ) or ( 2 ) usual clinic care alone ( control ) . We compared patients in the two study arms for changes in A1C and self-efficacy measured with the Diabetes Empowerment Scale . RESULTS A total of 77 patients were recruited from the diabetes clinic and enrolled in the trial . The mean baseline A1C among study participants was 8.0 % . We observed a nonsignificant decrease in average A1C ( -0.48 ; 95 % confidence interval -1.22 to 0.27 ; P = 0.160 ) in the intervention group compared to the usual care group . The intervention group had a significant increase in diabetes-related self-efficacy compared to usual care ( group difference of 0.30 ; 95 % confidence interval 0.01 to 0.59 ; P = 0.04 ) . CONCLUSIONS Use of a Web-based case management program was associated with a beneficial treatment effect on self-efficacy , but change in glycemic control did not reach statistical significance in this trial of patients with moderately poorly controlled type 1 diabetes . Larger studies may be necessary to further clarify the intervention 's impact on health outcomes
Output:
| We found mixed outcomes across both patient and HCP groups , with approximately half of the review s showing positive changes with record access .
Patients believe that record access increases their perception of control ; however , outcome measures thought to create psychological concerns ( such as patient anxiety as a result of seeing their medical record ) are still unanswered .
Nurses are more likely than physicians to gain time efficiencies by using a PAEHR system with the main concern from physicians being the security of the PAEHRs .
CONCLUSIONS This review implements a novel scoring system , which shows there is a lack of rigorous empirical testing that separates the effect of record access from other existing disease management programs .
Current research is too targeted within certain clinical groups ' needs , and although there are positive signs for the adoption of PAEHRs , there is currently insufficient evidence about the effect of PAEHRs on health outcomes for patients or HCPs |
MS213222 | ***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: A prospect i ve study involving 120 consecutive patients undergoing total hip replacement was performed to compare the effectiveness of aspirin ( high and low dose ) or a combination of heparin plus dihydroergotamine ( heparin-DHE ) in preventing isotopic and phlebographic deep vein thrombosis ( DVT ) , and to evaluate their effect on postoperative platelet changes . Phlebographic DVT was demonstrated in 9 cases ( 30 % ) in control group , in 1 ( 3.3 % ) in aspirin ( high-dose ) group ( p less than 0.01 ) , in 1 ( 3.3 % ) in aspirin ( low-dose ) group ( p less than 0.01 ) and in 5 ( 16.6 % ) in heparin-DHE group ( p = NS ) . Aspirin was able to reduce the postoperative increase in circulating platelet aggregates , platelet factor 4 and beta-thromboglobulin observed in control group . This study shows that aspirin is effective in the prevention of DVT for patients undergoing total hip replacement . Small aspirin dose ( 250 mg/day ) represents an effective form of prophylaxis in these patients A r and omized trial was carried out with 194 patients to compare the effectiveness of sodium warfarin or aspirin with that of placebo in the prevention of venous thromboembolism after surgery for fractured hip . Prophylaxis was commenced postoperatively and continued for 21 days or until patient discharge , whichever was earlier . All patients underwent surveillance with iodine 125-fibrinogen leg scanning and impedance plethysmography , with subsequent venography . Venous thromboembolism occurred in 13 patients ( 20.0 % ) in the warfarin group , 27 patients ( 40.9 % ) in the aspirin group , and 29 patients ( 46.0 % ) in the placebo group . Proximal vein thrombosis or pulmonary embolism occurred in 6 patients ( 9.2 % ) in the warfarin group , 7 patients ( 10.6 % ) in the aspirin group , and 19 patients ( 30.2 % ) in the placebo group . The results of this study show that sodium warfarin therapy is safe and effective in preventing thromboembolic complications in patients undergoing surgery for fractured hip , and that aspirin therapy is an equally safe and effective method for preventing proximal vein thrombosis or pulmonary embolism 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 This study compares the benefits of aspirin and warfarin prophylactic agents for patients with thromboembolic disease after total joint arthroplasty . It is a prospect i ve r and omized study of 388 patients having total hip or total knee surgery . All consecutive patients having total hip or total knee surgery were entered into this study and evaluated with preoperative and postoperative ventilation perfusion scans and a postoperative venogram . The aspirin and warfarin treatment groups were compared by size and location of venographically revealed clots and changes in ventilation perfusion scans . The results showed that there was no difference in the size or location of deep venous thrombosis in the aspirin or warfarin treatment groups . The venogram was negative in 44.5 % of patients ; 28.8 % had small calf clots , 16 % had large calf clots , 3.9 % had popliteal clots , and 6.7 % had femoral clots . Patients with total knee replacement had a 2.6 times greater incidence of calf deep venous thrombosis than patients with total hip replacement . There was no difference between the aspirin and warfarin groups in the incidence of changes in ventilation perfusion scans ( 18.9 % ) . There was no difference between the 2 groups in bleeding complications . The results suggest that aspirin and warfarin are equivalent in prophylaxis against thromboembolic disease , as determined by prevention of venographic changes or changes in ventilation perfusion scans We have evaluated the quality of life and functional outcome after unilateral primary total hip replacement ( THR ) . Between 5 January 1998 and 31 July 2000 , we recruited a consecutive series of 627 patients undergoing this procedure and investigated them prospect ively . Each was assessed before operation and review ed after six months , 18 months , three years and five years . The Short Form-36 Health Survey ( SF-36 ) and Harris Hip scores were evaluated at each appointment . All dimensions of the SF-36 except for mental health and general health perception , improved significantly after operation and this was maintained throughout the follow-up . The greatest improvement was seen at the six-month assessment . On average , women reported lower SF-36 scores pre-operatively , but the gender difference did not continue post-operatively . The Harris Hip scores improved significantly after operation , reaching a plateau after 18 months . The improved quality of life was sustained five years after THR OBJECTIVE To compare the health-related quality of life of people with osteoarthritis before and after primary total hip and knee replacement surgery with that of the general Australian population . DESIGN A prospect i ve cohort study . SETTING Three Sydney hospitals , public and private . PARTICIPANTS Patients with osteoarthritis undergoing primary total hip ( n = 59 ) and knee ( n = 92 ) joint replacement surgery . MAIN OUTCOME MEASURE Medical Outcomes Study Short Form ( SF-36 ) scores before and 12 months after joint replacement surgery ( compared with population norms ) . RESULTS Patients in each age group showed a significant improvement in health-related quality of life after joint replacement surgery in most scales of the SF-36 , particularly physical function , role physical and bodily pain . SF-36 scores for the 42 hip-replacement patients aged 55 - 74 years improved to equal or exceed the population norm on all scales . SF-36 scores of the 52 knee replacement patients aged 55 - 74 years improved , but physical function and bodily pain scores remained significantly worse than the population norm . SF-36 scores for both hip ( n = 17 ) and knee ( n = 40 ) replacement patients aged 75 years and over improved significantly , becoming similar to population norms for this age group . CONCLUSIONS Total hip or knee replacement for osteoarthritis significantly improves patient health and well-being at 12 months after surgery . Age alone should not be a barrier to surgery Aspirin has been demonstrated to be an effective prophylactic agent against postoperative venous thromboembolic disease , but the optimum dosage is unknown . We compared the efficacy of daily doses of 3.6 grams of aspirin ( high dose ) with that of 1.2 grams ( low dose ) in 182 patients . All patients were more than forty years old and all underwent a total hip replacement . This r and omized , prospect i ve , double-blind study was done using only objective dta for diagnosis . Twenty-three ( 44 per cent ) of fifty-two women who were treated with the low dose had thrombi , compared with eighteen ( 34 per cent ) of fifty-three women who were given the high dose . Thrombi developed in thirteen ( 32 per cent ) and in eighteen ( 49 per cent ) of thirty-seven men who were given the high dose . There were no statistically significant differences among the four groups , nor was there a significant difference among the subgroups that were determined according to prior history of venous thromboembolic disease . Therefore , the higher dose of aspirin was neither more nor less effective than the lower dose . Our data continue to support the use of 1.2 grams in men In a prospect i ve and controlled study , we compared the prophylactic effect of high-dose acetylsalicylic acid ( ASA ) and dihydroergotamine-heparin ( DHEH ) in 82 patients over 50 years of age undergoing total hip replacement . The patients were screened by pulmonary scan and 125I fibrinogen uptake . Phlebography was done if the 125 I fibrinogen test was positive . According to our criteria , thromboembolism developed in 9 of 40 receiving ASA and in 5 of 42 patients receiving DHEH . The effect of ASA was limited to men ; in 16 men on this therapy , none had thromboembolism versus 9 of 24 women . Twenty-two patients showed wound hematomas , but none needed surgical intervention A prospect i ve , r and omized study of the effectiveness of intraoperative and postoperative use of intermittent pneumatic compression , alone or in combination with oral administration of either aspirin or low-dose warfarin , was done of a consecutive series of patients who had a total hip replacement and were more than thirty-nine years old . All patients began walking by the third postoperative day . One hundred and ninety-six patients who had 217 total hip arthroplasties were included . Twenty-eight per cent of the procedures were revisions of a previous total hip replacement or of an endoprosthesis , and the remainder were primary arthroplasties . Patients were r and omized as to the type of prophylaxis that they received : intermittent pneumatic compression alone , seventy-six hips ; intermittent pneumatic compression and aspirin , seventy-two hips ; or intermittent pneumatic compression and low-dose warfarin , sixty-nine hips . Before discharge from the hospital , and at an average of seven days after the operation , all patients were evaluated for the presence of proximal deep-vein thrombosis with either venography on the side of the operation or with bilateral venous ultrasonography . The relative frequency with which thrombosis occurred in a proximal vein was not significantly different in the three groups ; the over-all relative frequency was 10 per cent . Intermittent compression during and after the operation effectively reduces the rate of proximal-vein thrombosis after total hip replacement . With the number of patients in our study , the effectiveness of this technique could not be shown to be augmented by oral administration of either aspirin or low-dose warfarin Two hundred seventy-five patients undergoing unilateral total knee arthroplasty were prospect ively r and omized to receive spinal epidural anesthesia ( SEA ) , a VenaFlow calf compression device , and enoxaparin ( group A ) or SEA , VenaFlow , and aspirin ( group B ) . Aspirin was started on the day of surgery , whereas enoxaparin was started 48 hours after surgery . Anticoagulants were continued for 4 weeks after surgery . All patients had an in-hospital ultrasound screening test on postoperative days 3 to 5 and a second follow-up ultrasound 4 to 6 weeks after surgery . The overall deep venous thrombosis rates in groups A and B were 14.1 % and 17.8 % ( P = not significant ) , respectively . When used in combination with pneumatic compression devices and SEA , enoxaparin was not superior to aspirin in preventing deep venous thrombosis after total knee arthroplasty BACKGROUND The study objective was to determine the relative efficacy and safety of a low-molecular-weight heparinoid ( Orgaran ) compared with aspirin for the prevention of postoperative venous thromboembolism in patients undergoing surgery for fractured hips . A double-blind , r and omized , controlled trial was used to study 251 consecutive eligible and consenting patients undergoing surgery for hip fracture in seven participating hospitals . METHODS AND RESULTS Patients received either fixed-dose Orgaran by subcutaneous injection every 12 hours in a dose of 750 anti-Factor Xa units or aspirin 100 mg orally twice daily ; both regimens were started 12 to 24 hours after surgery and continued for 14 days or until discharge , if sooner . All patients had postoperative 125I-fibrinogen leg scanning and impedance plethysmography . If the results of one or both tests were positive , then venography was performed . Otherwise , venography was done at day 14 , or sooner if the patient was ready for discharge . Pulmonary embolism in symptomatic patients was diagnosed on the basis of a high probability perfusion/ventilation lung scan , a positive angiogram , or a clinical ly significant embolism detected at autopsy . Evaluable venograms were obtained in 90 of the 125 patients r and omly assigned to receive Orgaran and in 87 of the 126 patients assigned to receive aspirin . Venous thromboembolism was detected in 25 ( 27.8 % ) patients in the Orgaran group and in 39 ( 44.3 % ) patients in the aspirin group . Thus , there was a relative risk reduction of 37 % with Orgaran ( P=.028 ; 95 % confidence interval , 3.7 % to 59.7 % ) . Six ( 6.8 % ) of 88 patients in the Orgaran group and 12 ( 14.3 % ) of 84 patients in the aspirin group developed proximal deep vein thrombosis or pulmonary embolism , a relative risk reduction of 52 % with Orgaran ( P=.137 ; 95 % confidence interval , -30.7 % to 84.6 % ) . Hemorrhagic complications occurred in 2 ( 1.6 % ) patients given Orgaran and 8 ( 6.4 % ) patients given aspirin ( P=.10 ) . There was one major bleed in the Orgaran group compared with four in the aspirin group . CONCLUSIONS This study demonstrates that Orgaran is significantly more efficacious than aspirin in preventing postoperative venous thromboembolism in patients undergoing surgery
Output:
| Compared with anticoagulation , aspirin may be associated with higher risk of DVT following hip fracture repair , although bleeding rates were substantially lower .
Aspirin was similarly effective after lower extremity arthroplasty and may be associated with lower bleeding risk . |
MS213223 | ***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 effect of oral oestriol ( 3 mg/day for 4 weeks followed by 2 mg/day for a further 6 weeks ) on the vaginal bacterial flora , vaginal cytology and urogenital symptoms was assessed in a double-blind , placebo-controlled study in 35 women with symptoms of the urogenital oestrogen deficiency syndrome . No significant differences were observed with regard to the occurrence or severity of urogenital symptoms , vaginal pH , karyopyknotic index ( KPI ) or the baseline results of vaginal bacterial cultures in the 18 patients ( mean age 71.6 + /- 1.0 years ) treated with oestriol and the 17 women ( mean age 72.6 + /- 1.4 years ) who received placebo tablets . A decrease in both vaginal pH ( P less than 0.001 ) and the proportion of faecal-type bacteria ( P less than 0.05 ) , and an increase in the KPI ( P less than 0.01 ) and the proportion of lactobacilli ( P less than 0.001 ) were recorded after 10 weeks of treatment with oral oestriol . At the end of the following 10 medication-free weeks all of these parameters except vaginal pH had returned to values that were not significantly altered from the corresponding baseline levels . In the patients treated with placebo no significant changes occurred in vaginal pH , KPI or the proportion of lactobacilli in vaginal cultures during the course of this study . Urogenital symptoms improved in both groups after medication ( and even after the medication-free period ) in relation to the baseline assessment , which reflects the latter 's subjective nature BACKGROUND In postmenopausal women , raloxifene hydrochloride has favorable effects on bone and lipid metabolism and does not stimulate reproductive tissues . The studies reported herein evaluated the long-term ( 3-year ) effects of raloxifene treatment on bone mineral density ( BMD ) , serum lipid levels , and drug tolerability in healthy postmenopausal women . METHODS A total of 1145 healthy European and North American postmenopausal women aged 45 through 60 years were enrolled in 2 parallel , double-blind , r and omized , placebo-controlled trials of identical design and r and omly assigned to receive raloxifene hydrochloride , 30 , 60 , or 150 mg , or placebo daily ; all groups received 400 to 600 mg of elemental calcium . Assessment s included measurements for BMD by dual-energy x-ray absorptiometry , markers of bone turnover , and serum lipid levels . RESULTS Lumbar spine BMD changed from baseline to 36 months as follows : placebo ( mean percentage change + SE ) , -1 . 32 % + 0.22 % ; raloxifene , 30 mg , 0.71 % + 0.23 % ; raloxifene , 60 mg , 1 . 28 % + 0.23 % ; and raloxifene , 150 mg , 1.20 % + 0.24 % . Comparable BMD changes were observed in the hip and total body . Biochemical markers of bone turnover were suppressed by raloxifene to normal premenopausal ranges through 3 years . Serum low-density lipoprotein cholesterol was reduced 7 % to 12 % below baseline through 3 years . Study withdrawals due to any reason ( 37 % ) and withdrawals due to adverse events ( 14 % ) were not different among groups . The only significant adverse effect of therapy was hot flashes ( 25 % in the 60-mg raloxifene group vs 18 % in the placebo group ) ; hot flashes were typically reported as mild and were not associated with study withdrawal ( 1.7 % for 60-mg raloxifene vs 2.4 % for placebo ) . CONCLUSIONS Raloxifene preserves BMD at important skeletal sites , lowers serum low-density lipoprotein cholesterol levels , and has a tolerability profile comparable to placebo . These results indicate a favorable benefit-risk profile of raloxifene for long-term use in healthy postmenopausal women . Arch Intern Med . 2000;160:3444 - 3450 Twenty-nine postmenopausal women with slight to severe stress urinary incontinence and estrogen deficiency symptoms in the urogenital tract were treated with estriol , p.o . 4 mg once daily , and either phenylpropanolamine ( PPA ) , p.o . 50 mg twice daily , or placebo for periods of 6 weeks according to a r and omized double-blind crossover schedule . At urodynamic recordings the maximum urethral closure pressure increased by 22 % with combined treatment ( p less than 0.001 ) and an additional effect of PPA to estriol was shown ( p = 0.022 ) . The pressure transmission ratio increased , by about 15 % , with both treatments ( p less than 0.07 ) . The number of leakage episodes was reduced by 28 % with combined treatment ( p = 0.007 ) , but not with estriol alone ( p = 0.08 ) . Both combined treatment and estriol alone reduced significantly ( p less than 0.01 ) the urinary incontinence complaints . Twelve women ( 43 % ) preferred combined treatment , while 7 ( 25 % ) preferred estriol alone . In women with initially slight to very severe urine loss , combined treatment reduced also ( p = 0.02 ) the amount of urine loss , measured at a st and ardized physical stress test . Signs of estrogen deficiency in vulva , vagina and urethra were reduced , 75 % ( p less than 0.001 ) or 65 % ( p = 0.001 ) with estriol given in combination with PPA or alone . Maturation index of both urethral and vaginal epithelium displayed significant changes . It is concluded that the combined treatment , PPA + estriol , by affecting both the muscular and mucosal factor of the urethra , is more effective than estriol alone for treatment of female stress urinary incontinence in the postmenopausal ages A r and omized open comparative cross-over trial was carried out in 20 postmenopausal women , mean age 69 years , suffering from urinary incontinence due to urethral sphincteric insufficiency . They were treated with phenylpropanolamine ( PPA ) 50 mg p.o . twice daily or estriol vaginal suppositories 1 mg daily separately and in combination for periods of 4 weeks . Urodynamic investigations were carried out before and after each period of treatment . Both PPA and estriol increased the maximal urethral closure pressure and the continence area significantly compared to the initial values , but combined treatment was substantially more effective . The functional urethral length increased significantly while on estriol . No significant change was registered in the bladder pressure or in the pressure transmission ratio . PPA was clinical ly more effective than estriol , but not sufficient to obtain complete continence . With combined treatment 8 patients became completely continent , 9 were considerably improved and only 1 patient remained unchanged . 2 patients dropped out of the study because of side effects . Combined treatment with PPA and estriol represents a recommendable treatment to postmenopausal women with urinary incontinence due to urethral sphincteric insufficiency The objective of the study was to assess the effects of low-dose vaginal treatment with oestradiol before vaginal operation . In a double-blind r and omized study including 43 postmenopausal women scheduled for vaginal repair operation for genital descensus , it was found that 7 patients suffered from concomitant urinary stress incontinence . Vagifem ( 25 micrograms oestradiol ) or placebo was administered as vaginal pessaries daily , 3 weeks prior to surgery and the clinical effects evaluated . One month postoperatively the prevalence of bacteriuria ( > 100,000 CFU/ml urine ) was significantly lower when using oestradiol than in the placebo group . At follow-up 3 years later 40 women ( 93 % ) answered the question naires . None received hormone replacement therapy . Nineteen percent in the preoperative oestradiol group and 11 % in the preoperative placebo group had had more than two episodes of cystitis treated with antibiotics . This difference is not statistically significant ( p > 0.05 ) . Recurrent cystitis was not correlated to bacteriuria postoperatively . Seventy-nine percent of the women with genital prolapse but only 29 % of the women with concomitant urinary stress incontinence were cured ( p < 0.05 ) . Neither preoperative oestradiol treatment nor body weight had any influence on relapse . Preoperative low-dose vaginal oestradiol treatment may reduce the incidence of bacteriuria in the immediate postoperative period but no long-lasting effects on recurrent cystitis or relapse were seen . Longer-lasting hormone replacement therapy may be necessary to achieve lasting effects CONTEXT AND OBJECTIVE Estriol is an estrogen with considerably weaker stimulatory effects on endometrial proliferation than estradiol . A study was conducted to determine the level of estrogen receptors ( ERs ) and progesterone receptors ( PRs ) in women who received 14-day vaginal estriol therapy , compared with those who did not receive this therapy . ER and PR gene expression was analyzed in the endometrium , myometrium and vagina of postmenopausal women treated with estriol . DESIGN AND SETTING Analytical cross-sectional study , at the Research Institute of the Polish Mothers ' Memorial Hospital , Lodz , Pol and . METHODS Twenty-seven postmenopausal women ( 57 - 74 years of age ) were included in the study . All of them were waiting for per vaginam hysterectomy or plastic surgery on the vagina and perineum because of uterine prolapse . ER and PR gene expression was determined by means of the technique of reverse transcription polymerase chain reaction ( RT-PCR ) . RESULTS In the estriol-treated patients , in comparison with the control group , a significant increase in ER gene expression was observed in the endometrium and vagina , while enhanced PR gene expression was found in the endometrium . However , under histological examination of the endometrium , estrogen stimulation of low and medium degree was diagnosed for 21.4 % and 14.3 % of the estriol-treated women , respectively . CONCLUSION The results obtained suggest that the women who received 14 days of treatment with vaginal estriol had higher ER and PR mRNA levels . No difference between these groups regarding endometrial proliferation was observed BACKGROUND No authors have investigated whether the administration of local oestrogens in addition to antimuscarinics could have a synergistic effect in the therapy of overactive bladder ( OAB ) . OBJECTIVES To compare the efficacy of antimuscarinics alone versus antimuscarinics in combination with local oestrogens for OAB ; to verify whether risk factors for lower antimuscarinic efficacy can be overcome by the concomitant use of local oestrogens . DESIGN , SETTING , AND PARTICIPANTS Some 229 postmenopausal women with symptomatic urodynamically proven detrusor overactivity were prospect ively enrolled at a tertiary level urogynaecology centre and divided into two groups . INTERVENTION Women in group 1 ( n=129 ) were prescribed tolterodine extended release ( ER ) 4 mg once daily ; women in group 2 ( n=100 ) were prescribed both tolterodine ER 4 mg and concomitant oestriol cream application once daily . MEASUREMENTS All women underwent clinical evaluation and urodynamics in accordance with the Good Urodynamic Practice s Guidelines . After 12 wk of treatment the two groups were compared in terms of subjective efficacy for OAB symptom improvement using a three-point scale . Nonresponders were compared to the patients who improved or were cured in order to identify risk factors for resistance to therapy . RESULTS AND LIMITATIONS There was no significant difference between the two groups in terms of efficacy of therapy : 80.6 % in group 1 versus 82 % in group 2 ( p=0.86 ) . Patients with urodynamically proven detrusor overactivity ( DO ) occurring during provocative manoeuvres and patients with coital incontinence during orgasm reported a higher failure rate both in the overall study population and in group 2 . A possible limitation of the study is the nonr and omised design . CONCLUSIONS No synergistic effect of local oestrogens and antimuscarinics in the treatment of OAB was found . Antimuscarinic treatment has lower cure rates in women with symptomatic DO complaining of incontinence at orgasm or in patients with DO following provocative manoeuvres . The association of local oestrogens does not influence the role of the two mentioned risk factors Objective To assess the efficacy and safety of intravaginal estriol administration on urinary incontinence , urogenital atrophy , and recurrent urinary tract infections in postmenopausal women . Design Eighty-eight postmenopausal women with urogenital aging symptoms were enrolled in this prospect i ve , r and omized , placebo-controlled study . Participants were r and omly divided into two groups , with each group consisting of 44 women . Women in the treatment group received intravaginal estriol ovules : 1 ovule ( 1 mg ) once daily for 2 weeks and then
Output:
| Urinary incontinence may be improved with the use of local oestrogen treatment .
Conversely , systemic hormone replacement therapy using conjugated equine oestrogen may worsen incontinence .
There were too few data to reliably address other aspects of oestrogen therapy , such as oestrogen type and dose , and no direct evidence comparing routes of administration .
The risk of endometrial and breast cancer after long-term use of systemic oestrogen suggests that treatment should be for limited periods , especially in those women with an intact uterus |
MS213224 | ***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 This study was conducted to compare ovarian activity of an oral contraceptive containing drospirenone ( drsp ) 3 mg plus ethinylestradiol ( EE ) 20 mcg administered in 24/4 regimen compared with the conventional 21/7 regimen , during intended use and following predefined dosing errors . STUDY DESIGN Women aged 18 - 35 years who ovulated or had a follicular diameter of > or=15 mm on or before Day 23 during a pretreatment cycle were admitted into this double-blind , r and omized study . Participants underwent 3 treatment cycles with drsp 3 mg/EE 20 mcg in a 24/4 ( n=52 ) or a 21/7 ( n=52 ) regimen . In the third treatment cycle , the initial three pills in both groups were replaced with placebos . Ovarian activity was classified using the Hoogl and scale during pretreatment and during Cycles 2 and 3 . RESULTS Suppression of ovarian activity was more pronounced with the 24/4 regimen -- the odds ratio for a lower Hoogl and score ( i.e. , greater ovarian suppression ) with the 24/4 regimen compared with the conventional 21/7 regimen were 6.01 ( 95 % CI : 2.29 - 17.94 ) and 3.06 ( 95 % CI : 1.44 - 6.65 ) for Cycles 2 and 3 , respectively . More women in the 24/4 regimen group had no ovarian activity 87.8 % vs. 56.0 % during Cycle 2 and 55.1 % vs. 30.0 % during Cycle 3 . The 24/4 regimen was associated with a more consistent suppression ( less fluctuation ) of endogenous estradiol . CONCLUSION The drsp 3 mg/EE 20 mcg oral contraceptive in a 24/4 regimen was associated with greater ovarian suppression ( despite intentional dosing error ) , which results in decreased hormonal fluctuations , and may increase contraceptive efficacy with the low-dose formulation OBJECTIVE : To estimate whether women receiving daily text-message reminders have increased oral contraceptive pill adherence compared with women not receiving reminders . METHODS : This r and omized controlled trial estimated whether there was an effect of daily text-message reminders on oral contraceptive pill adherence of new oral contraceptive pill users . Pill-taking was tracked for 3 months by an electronic monitoring device with wireless data collection . During the study period , participants assigned the intervention received a daily reminder text message . Eighty-two women were assigned r and omly to detect a 1.6±2.0 pill difference ( 90 % power , 5 % & agr ; , 15 % dropout ) . RESULTS : Participants were 79 % white , non-Hispanic , 99 % high school graduates , and 99 % nulliparous with a mean age of 22 years . Most reported condom use with past coital activity , and more than half reported prior emergency contraception use . The mean number of missed pills per cycle did not differ significantly between the groups : 4.9±3.0 for the text-message group and 4.6±3.5 for the control group ( P=.60 ) . The number of missed pills per cycle increased over the course of the study , but this pattern did not increase differentially between the groups . Adherence recorded by the electronic monitoring device indicated much poorer adherence than that recorded by patient diaries . Despite poor pill-taking , there were no pregnancies . CONCLUSION : Daily text-message reminders did not improve oral contraceptive pill adherence . Although the lack of benefit may be attributed to the frequent use of alternative reminder systems in the control group , the rate of missed pills when measured objective ly was still very high in both groups . CLINICAL TRIAL REGISTRATION : Clinical trials.gov , www . clinical trials.gov , NCT00733707 . LEVEL OF EVIDENCE : OBJECTIVE To compare ovulation inhibition and ovarian activity with 21-day and 24-day regimens of a low-dose combined oral contraceptive ( COC ) containing 60 microg of gestodene and 15 microg of ethinyl estradiol . DESIGN Interventional observational study . SETTING Reproductive medicine unit . PATIENT(S ) Fifty-eight healthy volunteers aged 18 - 35 years . INTERVENTION(S ) Ovarian activity was monitored every other day with the use of ultrasound to measure the diameters of follicle-like structures and blood sample s to measure serum concentrations of 17beta-E2 and progesterone . Subjects were observed for five cycles : pretreatment and posttreatment control cycles and three cycles in which the COC was administered for either 21 or 24 days of each cycle . MAIN OUTCOME MEASURE(S ) Occurrence of ovulation and evidence of ovarian activity . RESULT ( S ) The study was completed by 27 ( 90 % ) of the 30 subjects who received the 24-day regimen and by 24 ( 79 % ) of the 28 subjects who received the 21-day regimen . Ovulation was inhibited in all cycles in the 24-day group and in 74 of 75 cycles in the 21-day group . Luteinized unruptured follicles were seen in no cycles with the 24-day regimen and in 6 ( 8 % ) of 75 cycles with the 21-day regimen . Mean ovarian follicular development and serum 17beta-E2 and progesterone levels were lower in the 24-day group . CONCLUSION ( S ) The 24-day regimen is an innovative strategy for maintaining effective ovulation inhibition at ultra-low doses of contraceptive steroids Objectives The primary objective of this analysis was to characterise the steady-state pharmacokinetics ( PK ) of ethinylestradiol ( EE ) and drospirenone ( DRSP ) in a r and omised Phase III study that investigated the contraceptive efficacy and safety of three different regimens of EE 20 µg/DRSP 3 mg . Methods Non-linear mixed-effects modelling was used to develop population PK models for EE and DRSP . EE and DRSP serum concentrations were determined in blood sample s obtained from approximately 1100 healthy young women on two occasions during the first cycle ( Week 3 ) and after 6 months ( Week 27 ) of EE 20 µg/DRSP 3 mg use . EE 20 µg/DRSP 3 mg was administered as a flexible extended regimen [ 24–120 days ’ active hormonal intake followed by 4 days with no tablet intake ( tablet-free interval ) ] , a conventional 28-day cyclic regimen ( 24 days ’ active hormonal intake followed by 4 days of placebo tablets ) or a fixed extended regimen ( 120 days ’ uninterrupted active hormonal intake followed by a 4-day tablet-free interval ) over 1 year . Results The population PK of EE and DRSP in this population were successfully described using the developed population models . All three regimens led to similar steady-state drug exposure during long-term treatment . Only minor changes ( ≤8 % ) in the steady-state PK of EE and DRSP were observed between Week 3 and Week 27 of an extended regimen . Body weight ( BW ) and age had a small , statistically significant impact on the PK of EE and DRSP ( BW only ) in a covariate analysis , however , these changes were not considered to be clinical ly relevant . Conclusions Extending the established 24/4-day regimen of EE 20 µg/DRSP 3 mg does not change the known steady-state PK of EE and DRSP , suggesting that the clinical efficacy is also similar . This is in line with the published clinical results from this study We have examined the pharmacokinetic parameters derived from the analysis of plasma ethinyl estradiol ( EE ) and norethindrone levels after administration of a single dose of three bioequivalent norethindrone-1mg/mestranol (ME)-50 micrograms formulations ( Ortho-NovumR 1/50 , NorinylR 1/50 and Norcept-MR 1/50 ) and three norethindrone-1mg/ethinyl estradiol-35 micrograms formulations ( Ortho-Novum 1/35R , NorinylR 1/35 , Norcept-ER 1/35 ) in a r and omized crossover design involving 24 women for the 35 micrograms and 27 women for the 50 micrograms agents . Differences between the AUC-EE of pairs from the same manufacturer ( 1 + 35 and 1 + 50 ) were not significantly different , indicating that 50 micrograms of mestranol was equivalent to 35 micrograms ethinyl estradiol with respect to this pharmacokinetic parameter . The Cmax values were also similar . Inter-individual coefficients of variation ( C.V. ) for the AUC-EE were 47 % and 57 % for the 1 + 35 and 1 + 50 agents , respectively . Intra-individual C.V.s were 41 % and 42 % , respectively . For norethindrone , the AUC was larger with the 1 + 50 formulations than with the 1 + 35 group ( 87.9 vs. 72.8 pg hr/ml ) . Additionally , the Cmax values were larger for the 1/50 group ( 17.7 vs. 14.0 ) . Since the amount of norethindrone in the two dosage groups was the same , this difference in the pharmacokinetics between the 35 micrograms EE and the 50 micrograms ME formulations remains unexplained . The inter-individual C.V. averaged 56 % for both dosage groups . The intra-individual C.V.s were 17 % and 46 % for the 1 + 35 and 1 + 50 groups , respectively . The large variation in blood levels of ethinyl estradiol and norethindrone between and within individuals may overshadow clinical differences attributable to differences in dosage BACKGROUND Unscheduled bleeding may affect satisfaction and compliance with extended oral contraceptive ( OC ) regimens . The bleeding patterns of two variants of a flexible dosing regimen design ed to manage intracyclic bleeding problems during extended cycles were compared with that of a conventional OC regimen . STUDY DESIGN This was a 1-year , open-label , active-controlled , Phase 3 study conducted in the USA . Healthy women ( 18 - 45 years ) received an ethinylestradiol ( EE ) 20 mcg/drospirenone 3 mg OC in two flexible extended regimens or in a conventional 24/4 ( i.e. , 28-day ) regimen . The primary regimen [ management of intracyclic bleeding ( flexible(MIB ) ) regimen ] was an extended dosing regimen that required subjects to initiate 4-day tablet-free intervals after 3 days of breakthrough bleeding/spotting . An alternative extended regimen [ active period control ( flexible(APC ) ) regimen ] allowed subjects to initiate a 4-day tablet-free interval irrespective of the occurrence of bleeding . Bleeding profiles were compared between treatments . Efficacy and safety outcomes were also assessed . RESULTS The full analysis set comprised 1864 women ( flexible(MIB ) , N=1406 ; flexible(APC ) , N=232 ; conventional 24/4 , N=226 ) . Over 1 year , subjects in the flexible(MIB ) group experienced significantly fewer ( mean±SD , 40±30 ) bleeding/spotting days than those in the conventional 24/4 group ( 52±35 ) . The corresponding value in the flexible(APC ) group was 47±33 days . The pregnancy rate in the flexible(MIB ) group was 1.65 per 100 woman-years ( 95 % confidence interval , 0.96 - 2.65 ) . All three regimens were well tolerated . CONCLUSION A flexible(MIB ) dosing regimen of EE 20 mcg/drospirenone 3 mg is associated with good contraceptive efficacy and fewer bleeding/spotting days than the conventional 24/4 regimen BACKGROUND The study was conducted to evaluate follicular development and hormone patterns with three oral contraceptive ( OC ) regimens before , during and after the 7-day hormone-free interval ( HFI ) or 7-day ethinyl estradiol (EE)-supplemented interval . STUDY DESIGN The study is a single-center , open-label , prospect i ve , r and omized trial to evaluate pituitary-ovarian suppression with three OC regimens containing identical hormones : 30 mcg of EE and 150 mcg of levonorgestrel ( LNG ) . METHODS After a st and ard 21/7 OC baseline cycle , subjects were r and omized to one of three treatment groups : ( 1 ) three 21/7-day cycles of 150 mcg LNG/30 mcg EE for 21 days followed by 7 days of placebo ( n=10 ) ; ( 2 ) one 84/7-day cycle of 150 mcg LNG/30 mcg EE for 84 days followed by 7 days of placebo ( n=12 ) and ( 3 ) one 84/7EE-day cycle of 150 mcg LNG/30 mcg E
Output:
| Results There is considerable inter- and intra-individual variation in the absorption and metabolism of COCs .
This risk increases in typical users whenever the CFI is prolonged : late restarts are a common reason for pill omissions .
Shortening or eliminating the CFI improves contraceptive efficacy using the lowest doses available , without evidence to date of compromised safety .
Conclusions There is no scientific evidence to support a 7-day CFI and it should be replaced either by a continuous flexible regimen , or extended regimens with a shortened CFI , prescribed first-line .
In women preferring a monthly ‘ bleed ’ , a 4-day CFI similarly provides a greater safety margin when pills are omitted |
MS213225 | ***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 determinants of prognosis in patients with heart failure and preserved ejection fraction ( HF-PEF ) are poorly documented . Methods and Results —We evaluated data from 4128 patients in the I-PRESERVE trial ( Irbesartan in Heart Failure with Preserved Ejection Fraction Study ) . Multivariable Cox regression models were developed using 58 baseline demographic , clinical , and biological variables to model the primary outcome of all-cause mortality or cardiovascular hospitalization ( 1505 events ) , all-cause mortality ( 881 events ) , and HF death or hospitalization ( 716 events ) . Log N-terminal pro – B-type natriuretic peptide , age , diabetes mellitus , and previous hospitalization for HF were the most powerful factors associated with the primary outcome and with the HF composite . For all-cause mortality , log N-terminal pro – B-type natriuretic peptide , age , diabetes mellitus , and left ventricular EF were the strongest independent factors . Other independent factors associated with poor outcome included quality of life , a history of chronic obstructive lung disease , log neutrophil count , heart rate , and estimated glomerular filtration rate . The models accurately stratified the actual 3-year rate of outcomes from 8.1 % to 59.9 % ( primary outcome ) 2.7 % to 36.5 % ( all-cause mortality ) , and 2.1 % to 38.9 % ( HF composite ) for the lowest to highest septiles of predicted risks . Conclusions —In a large sample of elderly patients with HF and preserved EF enrolled in I-Preserve , simple clinical , demographic , and biological variables were associated with outcome and identified subgroups at very high and very low risk of events . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT00095238 Background —Exercise intolerance is the primary symptom in older patients with heart failure and preserved ejection fraction ( HFPEF ) ; however , little is known regarding its mechanisms and therapy . Methods and Results —Seventy-one stable elderly ( 70±1 years ) patients ( 80 % women ) with compensated HFPEF and controlled blood pressure were r and omized into a 12-month follow-up double-blind trial of enalapril 20 mg/d versus placebo . Assessment s were peak exercise oxygen consumption ; 6-minute walk test ; Minnesota Living with HF Question naire ; MRI ; Doppler echocardiography ; and vascular ultrasound . Compliance by pill count was excellent ( 94 % ) . Twenty-five patients in the enalapril group versus 34 in the placebo group completed the 12-month follow-up . During follow-up , there was no difference in the primary outcome of peak exercise oxygen consumption ( enalapril , 14.5±3.2 mL/kg/min ; placebo , 14.3±3.4 mL/kg/min ; P=0.99 ) , or in 6-minute walk distance , aortic distensibility ( the primary mechanistic outcome ) , left ventricle mass , or neurohormonal profile . The effect size of enalapril on peak exercise oxygen consumption was small ( 0.7 % ; 95 % CI , 4.2 % to 5.6 % ) . There was a trend toward improved Minnesota Living with HF Question naire total score ( P=0.07 ) , a modest reduction in systolic blood pressure at peak exercise ( P=0.02 ) , and a marginal improvement in carotid arterial distensibility ( P=0.04 ) . Conclusions —In stable , older patients with compensated HFPEF and controlled blood pressure , 12 months of enalapril did not improve exercise capacity or aortic distensibility . These data , combined with those from large clinical event trials , suggest that angiotensin inhibition does not substantially improve key long-term clinical outcomes in this group of patients . This finding contrasts sharply with observations in HF with reduced EF and highlights our incomplete underst and ing of this important and common disorder BACKGROUND Preliminary evidence suggests that meditative exercise may have benefits for patients with chronic systolic heart failure ( HF ) ; this has not been rigorously tested in a large clinical sample . We sought to investigate whether tai chi , as an adjunct to st and ard care , improves functional capacity and quality of life in patients with HF . METHODS A single-blind , multisite , parallel-group , r and omized controlled trial evaluated 100 out patients with systolic HF ( New York Heart Association class I-III , left ventricular ejection fraction ≤40 % ) who were recruited between May 1 , 2005 , and September 30 , 2008 . A group-based 12-week tai chi exercise program ( n = 50 ) or time-matched education ( n = 50 , control group ) was conducted . Outcome measures included exercise capacity ( 6- minute walk test and peak oxygen uptake ) and disease-specific quality of life ( Minnesota Living With Heart Failure Question naire ) . RESULTS Mean ( SD ) age of patients was 67 ( 11 ) years ; baseline values were left ventricular ejection fraction , 29 % ( 8 % ) and peak oxygen uptake , 13.5 mL/kg/min ; the median New York Heart Association class of HF was class II . At completion of the study , there were no significant differences in change in 6-minute walk distance and peak oxygen uptake ( median change [ first quartile , third quartile ] , 35 [ -2 , 51 ] vs 2 [ -7 , 54 ] meters , P = .95 ; and 1.1 [ -1.1 , 1.5 ] vs -0.5 [ -1.2 , 1.8 ] mL/kg/min , P = .81 ) when comparing tai chi and control groups ; however , patients in the tai chi group had greater improvements in quality of life ( Minnesota Living With Heart Failure Question naire , -19 [ -23 , -3 ] vs 1 [ -16 , 3 ] , P = .02 ) . Improvements with tai chi were also seen in exercise self-efficacy ( Cardiac Exercise Self-efficacy Instrument , 0.1 [ 0.1 , 0.6 ] vs -0.3 [ -0.5 , 0.2 ] , P < .001 ) and mood ( Profile of Mood States total mood disturbance , -6 [ -17 , 1 ] vs -1 [ -13 , 10 ] , P = .01 ) . CONCLUSION Tai chi exercise may improve quality of life , mood , and exercise self-efficacy in patients with HF . Trial Registration clinical trials.gov Identifier : NCT00110227 Background — Exercise training reduces the symptoms of chronic heart failure . Which exercise intensity yields maximal beneficial adaptations is controversial . Furthermore , the incidence of chronic heart failure increases with advanced age ; it has been reported that 88 % and 49 % of patients with a first diagnosis of chronic heart failure are > 65 and > 80 years old , respectively . Despite this , most previous studies have excluded patients with an age > 70 years . Our objective was to compare training programs with moderate versus high exercise intensity with regard to variables associated with cardiovascular function and prognosis in patients with postinfa rct ion heart failure . Methods and Results — Twenty-seven patients with stable postinfa rct ion heart failure who were undergoing optimal medical treatment , including & bgr;-blockers and angiotensin-converting enzyme inhibitors ( aged 75.5±11.1 years ; left ventricular [ LV ] ejection fraction 29 % ; & OV0312;o2peak 13 mL · kg−1 · min−1 ) were r and omized to either moderate continuous training ( 70 % of highest measured heart rate , ie , peak heart rate ) or aerobic interval training ( 95 % of peak heart rate ) 3 times per week for 12 weeks or to a control group that received st and ard advice regarding physical activity . & OV0312;o2peak increased more with aerobic interval training than moderate continuous training ( 46 % versus 14 % , P<0.001 ) and was associated with reverse LV remodeling . LV end-diastolic and end-systolic volumes declined with aerobic interval training only , by 18 % and 25 % , respectively ; LV ejection fraction increased 35 % , and pro-brain natriuretic peptide decreased 40 % . Improvement in brachial artery flow-mediated dilation ( endothelial function ) was greater with aerobic interval training , and mitochondrial function in lateral vastus muscle increased with aerobic interval training only . The MacNew global score for quality of life in cardiovascular disease increased in both exercise groups . No changes occurred in the control group . Conclusions — Exercise intensity was an important factor for reversing LV remodeling and improving aerobic capacity , endothelial function , and quality of life in patients with postinfa rct ion heart failure . These findings may have important implication s for exercise training in rehabilitation programs and future studies AIMS Diastolic dysfunction ( DD ) was identified as a predictor of adverse prognosis in heart failure with reduced ejection fraction ( HFREF ) . It is , however , unknown if DD is improved by exercise training , which is known to induce reverse remodelling , and if the training effect is attenuated in elderly HFREF patients . We therefore assessed DD in a cohort of referent controls ( RCs ) and HFREF patients and studied the response of DD to endurance exercise in two age groups ( ≤55 years and ≥65 years ) . METHODS AND RESULTS Sixty RC ( 30 ≤ 55 years , mean age 50 ± 5 years ; 30 ≥ 65 years , 72 ± 4 years ) and 60 HFREF patients ( 30 ≤ 55 years , 46 ± 5 years ; 30 ≥ 65 years , 72 ± 5 years , EF 28 ± 5 % ) were r and omized to 4 weeks of supervised endurance training or to a control group . Exercise training was effective in reducing LV isovolumetric relaxation time by 29 % in young and by 26 % in old HFREF patients ( P < 0.05 for both ) . As assessed by tissue Doppler , septal E ' increased by 37 % in young and by 39 % among old HFREF patients ( P < 0.005 for both ) result ing in a significant decrease in the E/E ' ratio from 13 ± 1 to 10 ± 1 in young and 14 ± 1 to 11 ± 1 in old HFREF patients ( P < 0.05 for both ) . Serum levels of N-terminal pro brain natriuretic peptide were significantly reduced after endurance training in HFREF patients of all ages . CONCLUSION In HFREF , diastolic function is significantly impaired in all age groups . Endurance training is highly effective in improving left ventricular diastolic function in HFREF patients regardless of age . This study is registered at Clinical Trials.gov ( number : NCT00176319 ) AIMS The purpose of this study was to evaluate whether yoga training in addition to st and ard medical therapy can improve cardiac function and reduce N terminal pro B-type natriuretic peptide ( NT pro BNP ) in heart failure ( HF ) . METHODS 130 patients were recruited and r and omized into two groups : Control Group ( CG ) ( n = 65 ) , Yoga Group ( YG ) . In YG , 44 patients and in CG , 48 patients completed the study . Cardiac function using left ventricular ejection fraction ( LVEF ) , myocardial performance index ( Tei index ) , and NT pro BNP , a biomarker of HF , was assessed at baseline and after 12 weeks . RESULT Improvement in LVEF , Tei index , and NT pro BNP were statistically significant in both the groups . Furthermore , when the changes in before and after 12 weeks were in percentage , LVEF increased 36.88 % in the YG and 16.9 % in the CG , Tei index was reduced 27.87 % in the YG and 2.79 % in the CG , NT pro BNP was reduced 63.75 % in the YG and 10.77 % in the CG . The between group comparisons from pre to post 12 weeks were significant for YG improvements ( LVEF , P < 0.01 , Tei index , P < 0.01 , NT pro BNP , P < 0.01 ) . CONCLUSION These results indicate that the addition of yoga therapy to st and ard medical therapy for HF patients has a markedly better effect on cardiac function and reduced myocardial stress measured using NT pro BNP in patients with stable HF Purpose Most training studies in patients with chronic heart failure ( CHF ) do not consider CHF aetiology in the interpretation of the results . About 60 % of the patients in those studies have ischemic CHF ( IHF ) and 40 % non-ischemic CHF ( NHF ) . Recently , we conducted a r and omized controlled trial to study three different training modalities in 60 patients with severe CHF , with a similar distribution of IHF and NHF patients . In the present post hoc analysis we compared the differences in training results between ischemic and non-ischemic patients . Methods Left ventricular ejection fraction ( EF ) , end diastolic volume ( EDV ) , end systolic volume ( ESV ) , measured with radionuclide ventriculography ( RNV ) and echocardiography , NT-pro BNP , peak oxygen uptake ( peak $ $ V_{{{\rm O}_{2 } } } $ $ ) , working
Output:
| Limited evidence exists as to the effect of exercise training on emerging biomarkers |
MS213226 | ***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 Considerable morbidity and mortality are still associated with congestive heart failure ( CHF ) syndromes , despite improvement in therapy . Activation of neurohormonal , inflammatory , and oxidative mechanisms has been shown to contribute to the significant morbidity and mortality . Erythropoietin ( EPO ) is a cytokine known to regulate erythroid proliferation , attenuate apoptosis and oxidative stress , and promote angiogenesis . We prospect ively evaluated the predictive value of baseline EPO , N-terminal pro-B-type natriuretic peptide , and C-reactive protein levels in patients with clinical ly controlled chronic CHF . METHODS One hundred eighty-eight out patients from a CHF clinic had baseline assessment of EPO , N-terminal pro-B-type natriuretic peptide , and C-reactive protein levels and a complete clinical data profile . These patients were followed up for 24 months for any hospitalization due to CHF or mortality . RESULTS Circulating EPO levels were higher in CHF patients and increased in subjects with higher New York Heart Association scores . Levels of EPO ( at a cutoff of 23 mU/mL ) and N-terminal pro-B-type natriuretic peptide ( cutoff at the median of 1556 pg/mL ) were found to be strong predictors of mortality and CHF hospitalization , whereas C-reactive protein levels ( cutoff of 10 mg/L ) predicted CHF hospitalizations but not mortality . Left ventricular ejection fraction was found to be a predictor of mortality but not of CHF hospitalizations . Serum levels of EPO were significantly correlated with N-terminal pro-B-type natriuretic peptide and C-reactive protein levels but not with left ventricular ejection fraction . CONCLUSION If confirmed in large-scale clinical studies , determination of circulating EPO levels may aid in predicting morbidity and mortality in patients with clinical ly controlled congestive CHF BACKGROUND Hyporesponders to erythropoietin-stimulating agents ( ESAs ) have been associated with an increased subsequent risk of death or cardiovascular events . We hypothesized that subjects who are hyporesponsive to erythropoietin alfa would have higher plasma volumes and lower red cell deficits than subjects who are responsive to therapy . METHODS As part of a prospect i ve , single blind , r and omized , placebo-controlled study comparing erythropoietin alfa with placebo in older adults ( n = 56 ) with heart failure and a preserved ejection fraction ( HFPEF ) , we performed blood volume analysis with the use of an indicator dilution technique with (131)iodine-labeled albumin . We evaluated differences in plasma volumes and red cell volumes in hyporesponders ( eg , < 1 g/dL increase in hemoglobin within the first 4 weeks of treatment with erythropoetin alfa ) compared with subjects who were responders and controls . RESULTS Nine of 28 subjects ( 32 % ) assigned to ESA were hyporesponders . Hyporesponders did not differ from responders nor control subjects by any baseline demographic , clinical , or laboratory parameter , including hemoglobin . Hyporesponders had a greater total blood volume expansion ( 1,264.7 ± 387 vs 229 ± 206 mL ; P = .02 ) but less of a red cell deficit ( -96.2 ± 126 vs -402.5 ± 80.6 mL ; P = .04 ) and a greater plasma volume expansion ( + 1,360.8 ± 264.5 vs + 601.1 ± 165.5 mL ; P = .01 ) . Among responders , the increase in hemoglobin with erythropoietin alfa was associated primarily with increases in red cell volume ( r = 0.91 ; P < .0001 ) as well as a decline in plasma volume ( r = -0.55 ; P = .06 ) . CONCLUSIONS Among older adults with HFPEF and anemia , hyporesponders to erythropoietin alfa had a hemodilutional basis of their anemia , suggesting that blood volume analysis can identify a cohort likely to respond to therapy BACKGROUND Iron deficiency may impair aerobic performance . This study aim ed to determine whether treatment with intravenous iron ( ferric carboxymaltose ) would improve symptoms in patients who had heart failure , reduced left ventricular ejection fraction , and iron deficiency , either with or without anemia . METHODS We enrolled 459 patients with chronic heart failure of New York Heart Association ( NYHA ) functional class II or III , a left ventricular ejection fraction of 40 % or less ( for patients with NYHA class II ) or 45 % or less ( for NYHA class III ) , iron deficiency ( ferritin level < 100 microg per liter or between 100 and 299 microg per liter , if the transferrin saturation was < 20 % ) , and a hemoglobin level of 95 to 135 g per liter . Patients were r and omly assigned , in a 2:1 ratio , to receive 200 mg of intravenous iron ( ferric carboxymaltose ) or saline ( placebo ) . The primary end points were the self-reported Patient Global Assessment and NYHA functional class , both at week 24 . Secondary end points included the distance walked in 6 minutes and the health-related quality of life . RESULTS Among the patients receiving ferric carboxymaltose , 50 % reported being much or moderately improved , as compared with 28 % of patients receiving placebo , according to the Patient Global Assessment ( odds ratio for improvement , 2.51 ; 95 % confidence interval [ CI ] , 1.75 to 3.61 ) . Among the patients assigned to ferric carboxymaltose , 47 % had an NYHA functional class I or II at week 24 , as compared with 30 % of patients assigned to placebo ( odds ratio for improvement by one class , 2.40 ; 95 % CI , 1.55 to 3.71 ) . Results were similar in patients with anemia and those without anemia . Significant improvements were seen with ferric carboxymaltose in the distance on the 6-minute walk test and quality -of-life assessment s. The rates of death , adverse events , and serious adverse events were similar in the two study groups . CONCLUSIONS Treatment with intravenous ferric carboxymaltose in patients with chronic heart failure and iron deficiency , with or without anemia , improves symptoms , functional capacity , and quality of life ; the side-effect profile is acceptable . ( Clinical Trials.gov number , NCT00520780 ) BACKGROUND A number of animal studies and our own clinical trials point towards a possible influence of the renin-angiotensin-system ( RAS ) on erythropoietin ( EPO ) production . In this study we investigated the role of angiotensin II in the regulation of EPO production in humans . METHODS After a hemorrhage of 750 ml as a basic physiological stimulus 72 healthy male volunteers received in a parallel design either placebo ( physiologic electrolyte solution ) for 6 h , angiotensin II i.v . for 6 h ( 1 - 3 microgram min-1 , sufficient to increase systolic blood pressure by 20 mmHg ) , the selective AT1-receptor antagonist losartan , the ACE-inhibitor captopril , angiotensin II + losartan , or angiotensin II + captopril . RESULTS Administration of angiotensin II alone and in combination with captopril result ed in a significantly higher Cmax EPO ( 67 % higher vs. placebo , P < 0.05 ) and AUCEPO ( 0 - 24h ) ( 40 % higher vs. placebo , P < 0.05 ) . In the groups receiving losartan or captopril alone or the combination of angiotensin II + losartan no significant difference of Cmax EPO and AUCEPO(0 - 24h ) compared to placebo could be detected . CONCLUSIONS This study shows in a model of controlled , basic physiological stimulation of renal EPO production that angiotensin II is able to increase EPO levels in humans . This effect of angiotensin II can be blocked by the specific AT1-receptor antagonist losartan but not by the ACE-inhibitor captopril . The result may be interpreted as a hint that one signal for the control of EPO production in humans may be mediated by angiotensin II (AT1)-receptors Background Anaemia and iron deficiency are frequent following major surgery . The present study aims to identify the iron deficiency patterns in cardiac surgery patients at their admission to a cardiac rehabilitation programme , and to determine which perioperative risk factor(s ) may be associated with functional and absolute iron deficiency . Design This was a retrospective study on prospect ively collected data . Methods The patient population included 339 patients . Functional iron deficiency was defined in the presence of transferrin saturation < 20 % and serum ferritin ≥100 µg/l . Absolute iron deficiency was defined in the presence of serum ferritin values < 100 µg/l . Results Functional iron deficiency was found in 62.9 % of patients and absolute iron deficiency in 10 % of the patients . At a multivariable analysis , absolute iron deficiency was significantly ( p = 0.001 ) associated with mechanical prosthesis mitral valve replacement ( odds ratio 5.4 , 95 % confidence interval 1.9–15 ) and tissue valve aortic valve replacement ( odds ratio 4.5 , 95 % confidence interval 1.9–11 ) . In mitral valve surgery , mitral repair carried a significant ( p = 0.013 ) lower risk of absolute iron deficiency ( 4.4 % ) than mitral valve replacement with tissue valves ( 8.3 % ) or mechanical prostheses ( 22.5 % ) . Postoperative outcome did not differ between patients with functional iron deficiency and patients without iron deficiency ; patients with absolute iron deficiency had a significantly ( p = 0.017 ) longer postoperative hospital stay ( median 11 days ) than patients without iron deficiency ( median nine days ) or with functional iron deficiency ( median eight days ) . Conclusions Absolute iron deficiency following cardiac surgery is more frequent in heart valve surgery and is associated with a prolonged hospital stay . Routine screening for iron deficiency at admission in the cardiac rehabilitation unit is suggested BACKGROUND Erythropoietin ( Epo ) , a growth factor produced by the kidney , is important in heart failure patients to promote oxygen delivery to tissues . Seventy-two chronic heart failure ( CHF ) patients at our outpatient clinic were subjected to morning serum Epo-level measurements and classified according to NYHA criteria . RESULTS Forty-eight patients of classes III and IV had a significantly elevated serum Epo-level of 42.9+/-40.3 mIU/ml ( mean+/-1 S.D. ) when compared to the mean level of 24 patients of classes I and II who had a normal range mean value of 13.4+/-6.2 mIU/ml ( P<0.05 ) . Patients on angiotensin-converting enzyme ( ACE ) inhibitors showed a trend towards lower serum Epo-levels compared to patients treated with angiotensin-II type-1 receptor antagonists ( AT(1 ) antagonists ) ( levels : 33.3+/-35.6 mIU/ml and 43.6+/-38.1 mIU/ml ) . This trend did not , however , reach statistical significance ( P=0.36 ) . CONCLUSION We suggest that a desirable Epo increase in class III and IV CHF patients could be achieved by either recombinant human Epo administration or , possibly , by appropriate selection of the concomitant medical therapy . A large prospect i ve study shall investigate the possible advantage of AT(1 ) antagonists over ACE-inhibitors with regard to Epo effect Background : Recombinant erythropoietin has become a routine component of care of patients with chronic kidney disease reducing the need for blood transfusions but raising the risks for cardiovascular events . We undertook this secondary analysis of subjects enrolled in the Correction of Hemoglobin and Outcomes in Renal Insufficiency ( CHOIR ) trial to examine the interrelationships between epoetin-alfa maintenance doses utilized and achieved hemoglobin ( Hb ) irrespective of treatment target and r and omized allocation . Methods : We performed a post hoc analysis from the CHOIR trial . Inclusion criteria were Hb < 11.0 g/dl and estimated glomerular filtration rates of 15 - 50 ml/min/1.73 m2 . To be included in the present analysis , subjects needed to be free of the composite event at 4 months , receive epoetin-alfa , and have ≥1 postbaseline Hb measurement . The mean weekly dose of epoetin-alfa received up to the time of first event or censure was the main exposure variable , while the achieved Hb at month 4 was the confounder representing the subject 's underlying response to treatment . The primary outcome was the composite of death , heart failure hospitalization , stroke , or myocardial infa rct ion . A Cox proportional hazard regression model was used in time-to-event analysis . Results : Among 1,244 subjects with complete data , the average weekly dose of epoetin-alfa ranged 143.3-fold from 133 to 19,106 units/week at the time of first event or censure . Cox proportional hazard analysis found that those in the middle tertile of Hb achieved ( > 11.5 to < 12.7 g/dl
Output:
| Conclusion Anaemia in heart failure is overwhelmingly characterized by impaired erythropoietin production , which is exacerbated with age , female sex , left ventricular ejection fraction , inflammation and disease severity |
MS213227 | ***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 investigate the effects of Qingre Huoxue Decoction 清热活血方 , clearing heat and promoting blood flow ; QRHXD ) , on the radiographic progression in patients with rheumatoid arthritis ( RA ) by X-ray imaging . Methods Eighty-six patients with active RA diagnosed as damp-heat and blood stasis syndrome were r and omized into a QRHXD group and a QRHXD plus methotrexate ( MTX ) group , with 43 cases in each group . After one-year of treatment , 21 cases in each group ( 42 in total ) were evaluated . Radiographs of h and s were obtained at the baseline and after 12 months of treatment . Images were evaluated by investigators blinded to chronology and clinical data , and assessed according to the Sharp/Van der Heijde methods . Results High intrareader agreements were reached ( mean intraobserver intraclass coefficients : 0.95 ) . No significant change in any imaging parameters of joint destruction was observed at 12 months in either group ; and the differences between the two groups were not significant ( P>0.05 ) . The mean of the changing score in the QRHXD group was 3.5±4.1 , and 2.4±3.5 in the QRHXD+MTX group , while the baseline radiographic score of patients in the QRHXD group was relatively higher ( 18.9±19.1 vs. 14.0±14.0 ) . The mean rates of the changing scores of the two groups were similar ( 0.24±0.28 vs. 0.25±0.44 , P=0.40 ) . The severity of progression in the two groups was also similar ( P=0.46 ) , 7 cases without radiographic progression in the QRHXD group and 8 in the QRHXD+MTX group , 3 cases with obvious radiographic progression in the QRHXD group and 1 in the QRHXD+MTX group . Conclusion Radiographic progression of RA patients in both groups is similar , indicating that the QRHXD Decoction has a potential role in preventing bone destruction Aim To monitor joint inflammation and destruction in rheumatoid arthritis ( RA ) patients receiving adalimumab/methotrexate combination therapy using MRI and ultrasonography . To assess the predictive value of MRI and ultrasonography for erosive progression on CT and compare MRI/ultrasonography/radiography for erosion detection/monitoring . Methods Fifty-two erosive biological-naive RA patients were followed with repeated MRI/ultrasonography/radiography ( 0/6/12 months ) and clinical /biochemical assessment s during adalimumab/methotrexate combination therapy . Results No overall erosion progression or repair was observed at 6 or 12 months ( Wilcoxon ; p>0.05 ) , but erosion progressors and regressors were observed using the smallest detectable change cut-off . Scores of MRI synovitis , grey-scale synovitis ( GSS ) and power Doppler ultrasonography decreased after 6 and 12 months ( p<0.05 ) , as did DAS28 , HAQ and tender and swollen joint counts ( p<0.001 ) . Patients with progression on CT had higher baseline MRI bone oedema scores . The RR for CT progression in bones with versus without baseline MRI bone oedema was 3.8 ( 95 % CI 1.5 to 9.3 ) and time-integrated MRI bone oedema , power Doppler and GSS scores were higher in bones/joints with CT progression ( Mann – Whitney ; p<0.05 ) . With CT as the reference method , sensitivities/specificities for erosion in metacarpophalangeal joints were 68%/92 % , 44%/95 % and 26%/98 % for MRI , ultrasonography and radiography , respectively . Median intraobserver correlation coefficient was 0.95 ( range 0.44–0.99 ) . Conclusion During adalimumab/methotrexate combination therapy , no overall erosive progression or repair occurred , whereas repair of individual erosions was documented on MRI , and MRI and ultrasonography synovitis decreased . Inflammation on MRI and ultrasonography , especially MRI bone oedema , was predictive for erosive progression on CT , at bone/joint level and MRI bone oedema also at patient level OBJECTIVE RANKL is essential for osteoclast development , activation , and survival . Denosumab is a fully human monoclonal IgG2 antibody that binds RANKL , inhibiting its activity . The aim of this multicenter , r and omized , double-blind , placebo-controlled , phase II study was to evaluate the effects of denosumab on structural damage in patients with rheumatoid arthritis ( RA ) receiving methotrexate treatment . METHODS RA patients received subcutaneous placebo ( n = 75 ) , denosumab 60 mg ( n = 71 ) , or denosumab 180 mg ( n = 72 ) injections every 6 months for 12 months . The primary end point was the change from baseline in the magnetic resonance imaging ( MRI ) erosion score at 6 months . RESULTS At 6 months , the increase in the MRI erosion score from baseline was lower in the 60-mg denosumab group ( mean change 0.13 ; P = 0.118 ) and significantly lower in the 180-mg denosumab group ( mean change 0.06 ; P = 0.007 ) than in the placebo group ( mean change 1.75 ) . A significant difference in the modified Sharp erosion score was observed as early as 6 months in the 180-mg denosumab group ( P = 0.019 ) as compared with placebo , and at 12 months , both the 60-mg ( P = 0.012 ) and the 180-mg ( P = 0.007 ) denosumab groups were significantly different from the placebo group . Denosumab caused sustained suppression of markers of bone turnover . There was no evidence of an effect of denosumab on joint space narrowing or on measures of RA disease activity . Rates of adverse events were comparable between the denosumab and placebo groups . CONCLUSION Addition of twice-yearly injections of denosumab to ongoing methotrexate treatment inhibited structural damage in patients with RA for up to 12 months , with no increase in the rates of adverse events as compared with placebo OBJECTIVE To observe the effect of Fengshi No. 1 ( FS1 ) in treating patients with active stage of rheumatoid arthritis ( RA ) . METHODS Patients with RA were r and omly divided into two groups , the 40 patients in the treated group were treated with combined therapy of methotrexate ( MTX ) , sulfasalazine ( SSZ ) and FS1 , and the 20 in the control groups were treated with MTX and SSZ alone . RESULTS In the treated group , the total effective rate was 97.5 % , the clinical controlled and markedly effective rate 95.0 % and the occurrence rate of side-toxic reaction 10.0 % , as compared with those in the control group , 60.0 % , 20.0 % and 45.0 % respectively , the difference was significant ( chi 2 = 11.91 , 32.23 and 7.67 respectively , all P < 0.01 ) . The effect in the treated group was superior to that in the control group in abating joint swelling and pain , improving function of joint , reducing immune indices and ameliorating iconographic features ( P < 0.01 or P < 0.05 ) . CONCLUSION FS1 not only has the effects of anti-inflammation , analgesis , regulating immune reaction , but also could retard the occurring of bone destruction , reduce the toxic-side effects of MTX and SSZ Objective To observe the efficacy of Hebi Formula ( HF ) combined Methotrexate ( MTX ) on early rheumatoid arthritis ( RA ) patients with disharmony of Gan and Pi syndrome ( DGPS ) and its effects on matrix metalloproteinase-3 ( MMP-3 ) activator of nuclear factor-KB/receptor activator of nu- clear factor-KB/osteoprotegerin ( RANK/RANKL/OPG ) . Methods Totally 72 early RA patients with DGPS were assigned to the treatment group and the control group according to r and om digit table , 36 in each group . Patients in the control group took MTX , while those in the treatment group additionally took HF . MTX dose was increased from 7 . 5 mg to 12 . 5 mg gradually , once per week , and the course of treatment was 24 weeks . Efficacy for Chinese medicine ( CM ) syndromes , ACR20 improvement rate , laboratory re- lated indices [ rheumatoid factor ( RF ) , erythrocyte sedimentation rate ( ESR ) , C-reactive protein ( CRP ) , anti-cyclic citrullinated peptide antibody ( CCP ) ] , serum levels of MMP-3 , OPG , RANKL , and adverse reactions were observed . Results The st and ard arriving rate of ACR20 was 82 . 86 % ( 2935 ) in the treatment group , higher than that in the control group [ 51 . 52 % ( 173 ) ; P < 0 . 05 ) . The effective rate of CM syndrome was 85 . 7 % ( 30f35 ) in the treatment group , higher than that in the control group [ 63 . 6 % ( 21/33 ) ; P < 0 . 05 ) . Compared with before treatment in the same group , levels of RF , ESR , CRP , MMP-3 , and RANKL decreased , the OPG level increased in the two groups after treatment ( P < 0 . 05 , P < 0 . 01 ) . Compared with the control group , levels of RF , ESR , CRP , and RANKL all decreased with statistical difference ( P < 0 . 01 , P < 0 . 05 ) . Liver dysfunction occurred in 1 case of the treatment group . Leucopenia occurred in 1 case and liver dysfunction occurred in 2 cases of the control group . Conclusion HF com- bined MTX could improve symptoms of early RA patients with DGPS , and regulate bone destruction in- duced by RANK/RANKL/OPG systems
Output:
| Conclusions : Chinese medicine may provide an efficiently alternative choice for the treatment of RA in terms of the bone-protecting efficiency . |
MS213228 | ***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 whether magnetic resonance imaging ( MRI ) cine-derived dyssynchrony indices provide additional information compared to conventional tagged MRI ( tMRI ) acquisitions in heart failure patients undergoing cardiac resynchronization therapy ( CRT ) . MATERIAL S AND METHODS Patients scheduled for CRT ( n = 52 ) underwent preprocedure MRI including cine and tMRI acquisitions . Segmental strain curves were calculated for both cine and tMRI to produce a range of st and ard indices for direct comparison between modalities . We also proposed and evaluated a novel index of " dyscontractility , " which detects the presence of focal areas with paradoxically positive circumferential strain . RESULTS Across conventional strain indices , there was only moderate-to-poor ( R = 0.3 - 0.6 ) correlation between modalities ; eight cine-derived indices showed statistically significant ( P < 0.05 ) relations to CRT outcome compared to just two tMRI-based counterparts . The novel dyscontractility index calculated on basal slice cine images ( cine dyscontractility index , " CDI " ) was the single best predictor of clinical response to CRT ( area under the curve AUC = 0.81 , P < 0.001 ) . While poorly correlated to its tMRI counterpart ( R = 0.33 ) , CDI performed significantly better in predicting response to CRT ( P < 0.005 ) , and was also numerically better than all other tMRI indices ( AUC 0.53 - 0.76 , all P for AUC comparisons < 0.17 ) . CONCLUSION Cine-derived strain indices offer potentially new information compared to tMRI . Specifically , the novel CDI is most strongly linked to response to cardiac resynchronization therapy in a contemporary patient cohort . It utilizes readily available MRI data , is relatively straightforward to process , and compares favorably with any conventional tagging index . J. Magn . Reson . Imaging 2016;44:1483 - 1492 AIMS The aim of the study was to assess the predictive value for outcomes of various response criteria currently used in patients undergoing cardiac resynchronization therapy ( CRT ) . METHODS AND RESULTS Data from TRUST CRT r and omized trial in patients with New York Heart Association ( NYHA ) III-IV class , QRS ≥ 120 ms , ejection fraction ≤ 35 % , and mechanical dyssynchrony was analysed . Ninety-seven subjects who survived 6 months after implantation of CRT-defibrillator were classified as responders or non-responders depending on 15 criteria used in most of the previous trials . Blindly adjudicated data on major adverse cardiac events ( MACEs ) within 1 year after classification were used to calculate the predictive value of response criteria . After adjustment for baseline confounding variables only eight criteria were significantly predictive for future MACEs . Sensitivity and specificity ranged substantially for clinical ( 32 - 94 % and 26 - 63 % ) and echocardiographic criteria ( 40 - 93 % and 22 - 70 % , respectively ) . The most powerful clinical predictor was > a NYHA class reduction ≥ 1 [ adjusted relative risk ( RR ) 4.41 for non-responders ; 95 % confidence interval ( CI ) 1.75 - 11.04 , P = 0.002 ] , while the strongest echocardiographic predictor was a reduction in the left ventricular end-systolic index by > 15 % ( RR 3.49 ; 95 % CI 1.59 - 7.64 , P = 0.002 ) . A combination of these two criteria did not improve the predictive value of a single parameter . Both criteria showed multiple significant interactions with baseline patients ' characteristics . CONCLUSION Only some of the commonly used response criteria predict outcome in patients undergoing CRT . The predictive value varies substantially across different criteria , with a higher sensitivity observed for the clinical parameters and a higher specificity observed for echocardiographic parameters . Combining various criteria adds little to their prognostic value . The predictive accuracy of various criteria can be different in various subgroups due to multiple interactions with baseline characteristics . CLINICAL TRIALS . GOV IDENTIFIER : NCT00814840 Background — Cardiac resynchronization therapy ( CRT ) decreases mortality , improves functional status , and induces reverse left ventricular remodeling in selected population s with heart failure . We aim ed to assess the impact of baseline QRS duration and morphology and the change in QRS duration with pacing on CRT outcomes in mild heart failure . Methods and Results — Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction ( REVERSE ) was a multicenter r and omized trial of CRT among 610 patients with mild heart failure . Baseline and CRT-paced QRS duration s and baseline QRS morphology were evaluated by blinded core laboratories . The mean baseline QRS duration was 151±23 milliseconds , and 60.5 % of subjects had left bundle-branch block ( LBBB ) . Patients with LBBB experienced a 25.3-mL/m2 mean reduction in left ventricular end-systolic volume index ( P<0.0001 ) , whereas non-LBBB patients had smaller decreases ( 6.7 mL/m2 ; P=0.18 ) . Baseline QRS duration was also a strong predictor of change in left ventricular end-systolic volume index with monotonic increases as QRS duration prolonged . Similarly , the clinical composite score improved with CRT for LBBB subjects ( odds ratio , 0.530 ; P=0.0034 ) but not for non-LBBB subjects ( odds ratio , 0.724 ; P=0.21 ) . The association between clinical composite score and QRS duration was highly significant ( odds ratio , 0.831 for each 10-millisecond increase in QRS duration ; P<0.0001 ) , with improved response at longer QRS duration s. The change in QRS duration with CRT pacing was not an independent predictor of any outcomes after correction for baseline variables . Conclusion — REVERSE demonstrated that LBBB and QRS prolongation are markers of reverse remodeling and clinical benefit with CRT in mild heart failure . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00271154 The aim of this study was to assess the effectiveness of cardiac resynchronization therapy ( CRT ) by intracardiac delay optimization using echocardiography . Sixty-five patients were implanted with a CRT device r and omly assigned to receive simultaneous biventricular pacing or echo-optimized sequential CRT . Forty-two patients were defined as responders and 23 patients were classified as non-responders . During a 12-month follow-up period , the positive response rate , QRS duration , New York Heart Association class , mitral insufficiency grade , left ventricular end-systolic volume and LV end-diastolic volume were similar in the optimized and non-optimized groups ( P>0.05 ) , whereas 6-minute walking distance , quality -of-life score , left ventricular ( LV ) ejection fraction and aortic velocity time integral were significantly improved in the optimized group ( P<0.05 ) . The baseline QRS duration s of the responders and non-responders were similar ( P>0.05 ) , whereas heart failure aetiology , clinical and echocardiographic measurements showed significant differences ( P<0.05 ) . The mean decrease in QRS duration after 12 months of CRT used for separating responders and non-responders was significantly different ( P<0.05 ) , and significant differences were observed in the mean decrease of QRS duration between responders and non-responders ( P<0.05 ) . Echocardiographic optimization may further improve the effectiveness of CRT . Moreover , severe mitral regurgitation and greater LV volume are likely to indicate a poor response to CRT In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias Background —Despite benefits of cardiac resynchronization therapy ( CRT ) in patients with severe but less symptomatic heart failure , approximately 30 % of patients do not fully respond to treatment . We hypothesized that a combined assessment of left ventricular ( LV ) dyssynchrony and contractile function by strain-based imaging would identify patients who would most benefit from CRT . Methods and Results —We studied 1077 patients with New York Heart Association class I/II , LV ejection fraction ⩽30 % and QRS width ≥130 ms enrolled in the Multicenter Automatic Defibrillator Implantation Trial – Cardiac Resynchronization Therapy trial with sufficient echocardiographic image quality for cardiac deformation analysis ( implantable cardioverter-defibrillator [ ICD ] , n=416 ; CRT , n=661 ) . Patients were assigned to CRT plus an ICD or to ICD alone in 3:2 r and om assignment . We assessed the degree to which baseline echocardiographic assessment s of dyssynchrony , measured as the st and ard deviation of time-to-peak transverse strain over 12 segments , contractile function , measured as global longitudinal strain , or both predicted the effect of treatment on the primary outcome of death or heart failure . With 213 primary events occurring over a mean of 2.4 years , the benefit of CRT plus an ICD relative to ICD alone was greatest in patients with mild to moderate dyssynchrony ( time-to-peak transverse strain st and ard deviation , 142 to 230 ms ) and greater baseline contractile function ( global longitudinal strain ⩽−8.7 % ) . Overall , those patients with mild to moderate dyssynchrony and those with best contractile function at baseline demonstrated the greatest benefit from CRT ( adjusted hazards ratio , 0.20 ; 95 % confidence interval , 0.09 to 0.44 ) . Dyssynchrony and global longitudinal strain predicted response to CRT independent of each other , QRS width , LV ejection fraction , and presence versus absence of left bundle-branch block , although the observed benefit remained greatest in patients with left bundle-branch block . Conclusions —Both mechanical dyssynchrony and contractile function are important independent correlates of benefit from CRT . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT00180271 Biventricular pacing results in left ventricular ( LV ) reverse remodeling in heart failure patients with wide QRS complexes . This study examines potential predictors of reverse remodeling . Echocardiography with tissue Doppler imaging was performed at baseline and 3 months after biventricular pacing in 30 patients ( 21 men and 9 women , mean age 62 + /- 14 years ) . There were 17 responders to reverse remodeling ( defined as a reduction in LV end-systolic volume by > 15 % ) and 13 nonresponders . Responders had significant improvement in 6-minute hall-walking distance ( p = 0.006 ) , metabolic equivalents ( p = 0.02 ) , peak oxygen uptake ( p = 0.02 ) , New York Heart Association functional class ( p < 0.001 ) , and quality of life ( p < 0.001 ) ; an increase in the sphericity index ( p = 0.007 ) , ejection fraction ( p < 0.001 ) , and diastolic filling time ( p = 0.03 ) ; a decrease in myocardial performance index ( p = 0.02 ) , isovolumic relaxation time ( p = 0.004 ) , and mitral regurgitation ( p = 0.007 ) ; and an improvement in systolic dyssynchrony ( SD of the time to peak myocardial systolic contraction of the 12 LV segments as dyssynchrony index ) ( 45.0 + /- 8.3 vs 32.5 + /- 14.5 ms , p = 0.003 ) . In contrast , nonresponders only had a small degree of clinical improvement in New York Heart Association class ( p = 0.03 ) and quality -of-life scores ( p = 0.03 ) , without any change in cardiac function , and worsening of systolic dyssynchrony ( 24.8 + /- 4.5 vs 34.1 + /- 13.5 ms , p = 0.02 ) . When all the above factors were put into univariate and multivariate analyses models , systolic dyssynchrony was the only independent predictor of reverse remodeling ( r = -0.76 , p < 0.001 ) ( beta = -1.54 , p = 0.007 ) . A preimplant dyssynchrony index of 3
Output:
| The observed association was independent of the timing of QRS width measurement after CRT implantation .
Acute and late improvement of electrical dysynchrony as depicted by QRS narrowing following biventricular pacing is associated with clinical and echocardiographic response to CRT . |
MS213229 | ***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 Systematic review s can include cluster-r and omised controlled trials ( C- RCTs ) , which require different analysis compared with st and ard individual-r and omised controlled trials . However , it is not known whether review authors follow the method ological and reporting guidance when including these trials . The aim of this study was to assess the method ological and reporting practice of Cochrane review s that included C- RCTs against criteria developed from existing guidance . Methods Criteria were developed , based on method ological literature and personal experience supervising review production and quality . Criteria were grouped into four themes : identifying , reporting , assessing risk of bias , and analysing C- RCTs . The Cochrane Data base of Systematic Review s was search ed ( 2nd December 2013 ) , and the 50 most recent review s that included C- RCTs were retrieved . Each review was then assessed using the criteria . Results The 50 review s we identified were published by 26 Cochrane Review Groups between June 2013 and November 2013 . For identifying C- RCTs , only 56 % identified that C- RCTs were eligible for inclusion in the review in the eligibility criteria . For reporting C- RCTs , only eight ( 24 % ) of the 33 review s reported the method of cluster adjustment for their included C- RCTs . For assessing risk of bias , only one review assessed all five C- RCT -specific risk-of-bias criteria . For analysing C- RCTs , of the 27 review s that presented unadjusted data , only nine ( 33 % ) provided a warning that confidence intervals may be artificially narrow . Of the 34 review s that reported data from unadjusted C- RCTs , only 13 ( 38 % ) excluded the unadjusted results from the meta-analyses . Conclusions The method ological and reporting practice s in Cochrane review s incorporating C- RCTs could be greatly improved , particularly with regard to analyses . Criteria developed as part of the current study could be used by review authors or editors to identify errors and improve the quality of published systematic review s incorporating C- RCTs Background The massive scale-up of insecticide-treated nets ( ITNs ) and indoor residual spraying ( IRS ) has led to a substantial increase in malaria vector insecticide resistance as well as in increased outdoor transmission , both of which hamper the effectiveness and efficiency of ITN and IRS . Long-lasting microbial larvicide can be a cost-effective new supplemental intervention tool for malaria control . Methods / design We will implement the long-lasting microbial larvicide intervention in 28 clusters in two counties in western Kenya . We will test FourStar controlled release larvicide ( 6 % by weight Bacillus thuringiensis israelensis and 1 % Bacillus sphaerius ) by applying FourStar controlled release granule formulation , 90-day briquettes , and 180-day briquettes in different habitat types . The primary endpoint is clinical malaria incidence rate and the secondary endpoint is malaria vector abundance and transmission intensity . The intervention will be conducted as a two-step approach . First , we will conduct a four-cluster trial ( two clusters per county , with one of the two clusters r and omly assigned to the intervention arm ) to optimize the larvicide application scheme . Second , we will conduct an open-label , cluster-r and omized trial to evaluate the effectiveness and cost-effectiveness of the larvicide . Fourteen clusters in each county will be assigned to intervention ( treatment ) or no intervention ( control ) by a block r and omization on the basis of clinical malaria incidence , vector density , and human population size per site . We will treat each treatment cluster with larvicide for three rounds at 4-month intervals , followed by no treatment for the following 8 months . Next , we will switch the control and treatment sites . The former control sites will receive three rounds of larvicide treatment at appropriate time intervals , and former treatment sites will receive no larvicide . We will monitor indoor and outdoor vector abundance using CO2-baited CDC light traps equipped with collection bottle rotators . Clinical malaria data will be aggregated from government-run malaria treatment centers . Discussion Since current first-line vector intervention methods do not target outdoor transmission and will select for higher insecticide resistance , new methods beyond bed nets and IRS should be considered . Long-lasting microbial larviciding represents a promising new tool that can target both indoor and outdoor transmission and alleviate the problem of pyrethroid resistance . It also has the potential to diminish costs by reducing larvicide reapplications . If successful , it could revolutionize malaria vector control in Africa , just as long-lasting bed nets have done . Trial registration U.S. National Institute of Health , study ID NCT02392832 . Registered on 3 February 2015 The optimization of malaria control strategies is complicated by constraints posed by local health systems , infrastructure , limited re sources , and the complex interactions between infection , disease , and treatment . The purpose of this paper is to describe the protocol of a r and omized factorial study design ed to address this research gap . This project will evaluate two malaria control interventions in Mvomero District , Tanzania : ( 1 ) a disease management strategy involving early detection and treatment by community health workers using rapid diagnostic technology ; and ( 2 ) vector control through community-supported larviciding . Six study villages were assigned to each of four groups ( control , early detection and treatment , larviciding , and early detection and treatment plus larviciding ) . The primary endpoint of interest was change in malaria infection prevalence across the intervention groups measured during annual longitudinal cross-sectional surveys . Recurring entomological surveying , household surveying , and focus group discussion s will provide additional valuable insights . At baseline , 962 households across all 24 villages participated in a household survey ; 2,884 members from 720 of these households participated in subsequent malariometric surveying . The study design will allow us to estimate the effect sizes of different intervention mixtures . Careful documentation of our study protocol may also serve other research ers design ing field-based intervention trials Introduction The efficacy of Vectobac GR ( potency 200 ITU/mg ) , a new formulation of bacterial larvicide Bacillus thuringiensis var . israelensis Strain AM65 - 52 , was evaluated against Anopheles gambiae and Culex quinquefasciatus in simulated field and natural habitats in Benin . Methods In simulated field conditions , Vectobac GR formulation was tested at 3 dosages ( 0.6 , 0.9 , 1.2 g granules/m2 against An . gambiae and 1 , 1.5 , 2 g granules/m2 against Cx . quinquefasciatus ) according to manufacturer ’s product label recommendations . The dosage giving optimum efficacy under simulated field conditions were evaluated in the field . The efficacy of Vectobac GR in terms of emergence inhibition in simulated field conditions and of reduction of larval and pupal densities in rice fields and urban cesspits was measured following WHO guidelines for testing and evaluation of mosquito larvicides . Results Vectobac GR caused emergence inhibition of ≥80 % until 21 [20]–[22 ] days for An . gambiae at 1.2 g/m2 dose and 28 [ 27–29 ] days for Cx . quinquefasciatus at 2 g/m2 in simulated field habitats . The efficacy of Vectobac GR in natural habitats was for 2 to 3 days against larvae and up to 10 days against pupae . Conclusions Treatment with Vectobac GR caused complete control of immature mosquito within 2–3 days but did not show prolonged residual action . Larviciding can be an option for malaria and filariasis vector control particularly in managing pyrethroid-resistance in African malaria vectors . Since use of larvicides among several African countries is being emphasized through Economic Community of West Africa States , their epidemiological impact should be carefully investigated Background Outdoor malaria transmission is becoming an increasingly important problem in malaria control in Africa . Larval control is a promising intervention as it can target both indoor and outdoor biting mosquitoes . However , the currently available biolarvicide formulations have a short effective duration , and consequently larval control incurs a high operational expense due to the requirement for frequent re-treatment of larval habitats . Formulations of biolarvicides with long-lasting effects is highly desired . A recently developed FourStar ® slow-release briquet formulation of Bacillus thuringiensis israelensis and Bacillus sphaericus was evaluated to test its efficacy on malaria vectors . Methods The study evaluated FourStar ™ briquets 180-days formulation under semi-natural and natural conditions to test their efficacy in reducing the mosquito population in western Kenya . The semi-natural habitats used the formulation dissolved in rainwater with appropriate concentrations , and second-instar larvae of Anopheles gambiae were introduced and the number of surviving larvae and pupae produced was recorded daily as the outcome . The briquets formulation was then tested in natural habitats for efficacy on pupal productivity reduction in highl and and lowl and sites in western Kenya . The formulation was finally tested for efficacy in reducing adult mosquito population s in r and omized clusters in western Kenya highl and . Results In semi-natural conditions , the FourStar ™ briquets 180-days formulation completely inhibited mosquito pupal production in the first 3 months , and then reduced pupal productivity by 87–98 % ( P < 0.001 ) 4–6 months after application . In natural habitats , during the first 2 months no pupae were detected from any of the treated habitats in highl and sites , and Anopheles spp . pupal density was reduced by 60–90 % in the next 3–5 months ( P < 0.001 ) . In the lowl and site , pupal productivity reduction was 100 % in the first 3 months , and 75–90 % in the next 4–5 months ( P < 0.001 ) . The r and omized cluster trial found that the application of the briquets formulation reduced mean densities of indoor-biting mosquitoes by 76–82 % ( P < 0.001 ) and by 67–75 % ( P < 0.001 ) for outdoor-biting mosquitoes . Conclusion This study demonstrated that long-lasting biological larviciding was effective in reducing pupal productivity of larval habitats , and reducing indoor and outdoor resting mosquitoes . The study suggests that long-lasting microbial larviciding may be a promising complementary malaria vector control tool and warrants further large-scale evaluation Background The use of larval source management is not prioritized by contemporary malaria control programs in sub-Saharan Africa despite historical success . Larviciding , in particular , could be effective in urban areas where transmission is focal and accessibility to Anopheles breeding habitats is generally easier than in rural setting s. The objective of this study is to assess the effectiveness of a community-based microbial larviciding intervention to reduce the prevalence of malaria infection in Dar es Salaam , United Republic of Tanzania . Methods and Findings Larviciding was implemented in 3 out of 15 targeted wards of Dar es Salaam in 2006 after two years of baseline data collection . This intervention was subsequently scaled up to 9 wards a year later , and to all 15 targeted wards in 2008 . Continuous r and omized cluster sampling of malaria prevalence and socio-demographic characteristics was carried out during 6 survey rounds ( 2004–2008 ) , which included both cross-sectional and longitudinal data ( N = 64,537 ) . Bayesian r and om effects logistic regression models were used to quantify the effect of the intervention on malaria prevalence at the individual level . Effect size estimates suggest a significant protective effect of the larviciding intervention . After adjustment for confounders , the odds of individuals living in areas treated with larviciding being infected with malaria were 21 % lower ( Odds Ratio = 0.79 ; 95 % Credible Intervals : 0.66–0.93 ) than those who lived in areas not treated . The larviciding intervention was most effective during dry seasons and had synergistic effects with other protective measures such as use of insecticide-treated bed nets and house proofing ( i.e. , complete ceiling or window screens ) . Conclusion A large-scale community-based larviciding intervention significantly reduced the prevalence of malaria infection in urban Dar es Salaam Background Malaria control in Africa is most tractable in urban settlements yet most research has focused on rural setting s. Elimination of malaria transmission from urban areas may require larval control strategies that complement adult mosquito control using insecticide-treated nets or houses , particularly where vectors feed outdoors . Methods and Findings Microbial larvicide ( Bacillus thuringiensis var . israelensis ( Bti ) ) was applied weekly through programmatic , non-r and omized community-based , but vertically managed , delivery systems in urban Dar es Salaam , Tanzania . Continuous , r and omized cluster sampling of malaria infection prevalence and non-r and om programmatic surveillance of entomological inoculation rate ( EIR ) respectively constituted the primary and secondary outcomes surveyed within a population of approximately 612,000 residents in 15 fully urban wards covering 55 km2 . Bti application for one year in 3 of those wards ( 17 km2 with 128,000 residents ) reduced crude annual transmission estimates ( Relative EIR [ 95 % Confidence Interval ] = 0.683 [ 0.491–0.952 ] , P = 0.024 ) but program effectiveness peaked between July and September ( Relative EIR [ CI ] = 0.354 [ 0.193 to 0.650 ] , P = 0.001 ) when 45 % ( 9/20 ) of directly observed transmission events occurred . Larviciding reduced malaria in
Output:
| Ground larviciding for non-extensive larval habitats may have an effect on malaria transmission , and we do not know if there is an effect in large-scale aquatic habitats .
We found no studies using larviciding application techniques that could cover large aquatic habitats , such as aerial spraying using aircraft |
MS213230 | ***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: Polyclonal intravenous IgG ( IVIG ) was administered as an infusion 6 times every 3 weeks ( week 0 , 3 , 6 , 9 , 12 , 15 ) in doses of 0.1 , 0.4 and 0.8 g/kg BW to determine the dose causing an increase in 12 pneumococcal antibody types above the protective level of 200 ng/ml of antibody N. The dose of 0.4 g/kg BW was found to be optimal in patients with chronic lymphocytic leukaemia ( CLL ) . From the first infusion onwards at least 80 % of CLL patients had increases in all 12 antibodies . Five weeks after the last infusion the antibody levels were still elevated in 80 % of patients with CLL . The dose of 0.8 g/kg raised all 12 antibodies in 53 - 73 % of CLL patients when assessment s were made after each infusion . In multiple myeloma ( MM ) patients , 73 - 82 % and 73 - 91 % of patients had increased antibody levels , respectively , before and after the 4th-6th infusions at the 0.8 g/kg dose level . However , in only 45 - 50 % of patients did the antibodies remain increased 2 weeks after the treatment at this dose . The dose of 0.4 g/kg caused antibody increases in only 30 - 50 % of patients when measured before the 4th-6th infusion . Serum IgG increased significantly only in the CLL patients , whereas in the MM patients it was high from the beginning owing to the disease . Therefore , the pneumococcal antibody levels were a better marker for the purpose of dose finding . The dosage recommendation in CLL is 0.4 g/kg every 3 weeks until week 12 , when steady state is reached . The maintenance dose is 0.4 g/kg every 5 weeks . In MM patients , who have a faster elimination rate of antibodies , the recommended loading dose is 0.8 g/kg , followed by 0.4 g/kg every week as a continuous treatment . Treatment with IVIG in CLL and MM was generally well tolerated . Only 25 % of patients experienced minor side-effects , the most frequent being febrile reactions , shivering and headache Patients treated with allogeneic bone marrow transplantation ( BMT ) suffer from a deficient humoral immunity during the post-transplant period . To prevent infections patients may receive prophylactic intravenous immunoglobulin ( IVIG ) therapy from 1 week before to 3 months after BMT . We have studied the effect of IVIG treatment on reconstitution of immunoglobulin repertoires in transplanted patients . Sera obtained from 13 IVIG-treated and 31 non-IVIG-treated patients before and at different time points after BMT , ranging from 3 days to 3 years , and from 18 healthy controls , were analyzed using a quantitative immunoblot system . The average immunoglobulin (Ig)M and IgG reactivity profiles against antigens derived from human liver , muscle and skin as well as Staphylococcus epidermidis protein extracts were similar in both patient groups and in controls . Both IgG and IgM reactivity profiles are , however , less heterogeneous among the individuals in the IVIG-treated patient group . Around 1 year after BMT the heterogeneity of the IgM reactivity profiles against allogeneic protein extracts is much lower in the IVIG-treated group compared to the non-IVIG-treated group and the healthy controls . This effect remains months to years after the IVIG treatment has been completed . Our results suggest that IVIG influences selection of the natural antibody repertoire mediated by the variable (V)-region during reconstitution after BMT To determine whether intravenous immunoglobulin ( IVIg ) given monthly from day 90 to day 360 posttransplantation decreased the incidence of late infection , chronic graft-vs.-host disease ( GVHD ) , and obliterative bronchiolitis after marrow transplantation , patients were assigned r and omly to receive either IVIg ( 500 mg/kg/month ) or no IVIg prophylaxis . Participants were registered before transplantation , and 250 patients ( 123 IVIg and 127 control ) were evaluable for events after day 100 . The two groups were balanced for age , marrow source , cytomegalovirus ( CMV ) seropositivity , pretransplantation conditioning , and prophylaxis for infection and GVHD . Between days 100 and 365 posttransplantation , the incidence of bacteremia or septicemia per 100 patient-days of risk was 0.10 in the IVIg group and 0.12 in the controls ( p = not significant ) . During the same period , the incidence of localized infection was marginally higher in control patients than in IVIg recipients ( 0.44 vs. 0.24 , respectively ; relative risk [ RR ] 1.46 , p < 0.07 ) . Administration of IVIg prophylaxis had no effect on survival , the incidence of obliterative bronchiolitis , severity of airflow obstruction , or the incidence or mortality of chronic GVHD . After discontinuing IVIg prophylaxis at day 360 , subsequent recovery of endogeneous humoral immunity was impaired ( serum IgG1 and IgA levels were significantly lower than controls at day 730 ) , and total infections were less common in the second year in control patients than in former IVIg recipients ( 0.12 vs 0.19 , respectively ; RR 0.61 , p = 0.03 ) . We conclude that in the absence of hypogammaglobulinemia , monthly administration of IVIg given from day 90 to 360 does not reduce late complications and may impair long-term humoral immune recovery after marrow transplantation In a study of 63 allogeneic and autologous bone marrow transplants , patients were r and omized to receive the IgM and IgA enriched intravenous immunoglobulin ( IVIG ) preparation ( Pentaglobin ) . Pentaglobin has been postulated to have anti-endotoxin properties and one of the aims of the study was to measure endotoxin levels in these patients together with the clinical sequelae of infection . The anti-endotoxin effects of Pentaglobin were found to reside in the IgM fraction . Those patients who received Pentaglobin were significantly protected from dying from infection in the first 100 days after the transplant , although it was not actually possible to document bacterial infections as the cause of death in the control patients . Peak endotoxin levels were significantly reduced ( p = 0.02 ) in those patients receiving Pentaglobin . Liver damage as assessed by liver enzyme abnormalities correlated significantly with the presence of endotoxaemia greater than 25 pg/ml and up to 70 % of pyrexial episodes were associated with endotoxaemia . Our results suggest that Pentaglobin is useful in reducing hepatic toxicity and this may be related to a reduction in endotoxaemia Overwhelming infections cause significant morbidity and mortality in the immunocompromised host . There is considerable in vitro and in vivo evidence that the immune deficient state which accompanies acute leukaemia , and , is exacerbated by intensive chemotherapy , contributes to the infection risk in these patients . The most easily documented and corrected is that of impaired humoral immunity . In order to study the clinical significance of the deficit a double blind , r and omised , placebo controlled pilot study was set up design ed to test the feasibility , efficacy and toxicity of using prophylactic intravenous immunoglobulin to prevent infective complications in this patient group . Patients received 150 mg/kg of Pentaglobin , an immunoglobulin preparation specifically enriched in IgM and IgA , on days 0 , 10 and 20 of the chemotherapy regimes . There were no adverse side effects . Patients in the placebo group had a 25 % fall in IgM level whilst IgG and IgA remained unchanged . The treatment group maintained a stable IgM and IgG concentration throughout but had a rise in IgA. There was no difference in the total number of septicaemic episodes in each group but the placebo group had an increased number of non Staphylococcal infections ( P < 0.04 ) . We conclude that intravenous Pentaglobin protects patients against a fall in IgM during induction chemotherapy for acute leukaemia and decreases the number of non Staphylococcal infections A r and omized crossover study of prophylactic immunoglobulin ( IgG ) therapy was performed in patients with chronic lymphocytic leukaemia ( CLL ) or non-Hodgkin 's lymphoma ( NHL ) . Twelve patients with hypogammaglobulinemia or a history of recurrent infections received infusions of IgG or placebo intravenously ( IV ) every 3 weeks for 1 year . They were then switched to the alternative preparation for another year . The number of serious bacterial infections was significantly less ( P = .001 ; Mainl and 's cross-over method ) in the months in which patients received IgG. Serious bacterial infections showed a trend to be associated with an IgG level less than 6.4 g/L ( P = .046 ; Fisher 's exact test ) Forty-two patients with chronic lymphocytic leukaemia ( CLL ) , serum IgG levels < 5.5 milligrams and a history of two or more recent infections , were r and omized to receive infusions of 18 g human intravenous immunoglobulin ( IVIg ) or human albumin placebo every three weeks . During the 12 month study 122 infections were documented but only four were associated with neutropenia . Ten patients ( 24 % ) with IgG levels < 3.0 milligrams experienced 65 % of the infections . In response to IVIg there were immediate and accumulative increases in serum IgG levels and an associated decrease in total and serious infections . If three further infections occurred , placebo patients were commenced on 18 g IVIg , and IVIg patients were increased to 24 g IVIg . Approximately 50 % of these cases subsequently remained infection free . The study shows the usefulness of prophylactic S and oglobulin in CLL patients with hypogammaglobulinaemia , and suggests that this may be justified in those with recurrent infections and serum IgG levels < 3 milligrams Treatment with intense myelosuppressive therapy ( including bone marrow transplantation ) has improved survival in patients with various malignant neoplasms [ 1 , 2 ] . Unfortunately , this treatment increases the incidence of infectious complications , primarily during the period of myelosuppression [ 3 ] . Various methods have been used to limit infection during myelosuppression [ 4 - 7 ] . Despite these pre caution s , bacteremia and fungemia continue to occur in at least one third of patients with sustained neutropenia . Intravenous immunoglobulin ( IVIG ) therapy prevents infections in patients with inborn B-cell deficiencies and hypogammaglobulinemia secondary to hematologic disorders such as chronic lymphocytic leukemia [ 8 - 10 ] . Intravenous immunoglobulin has also been used successfully to treat immune thrombocytopenic purpura , alloimmunity to platelets , and other immune-mediated disorders by a mechanism of immune system modulation [ 11 ] . After allogeneic bone marrow transplantation , IVIG is commonly used to prevent graft-versus-host disease [ 12 ] . During these bone marrow transplant trials , a reduction in bacterial infection was also observed in patients who were not necessarily hypogammaglobulinemic . This finding was initially reported in small anecdotal series but was later confirmed by large prospect i ve studies [ 12 - 17 ] . This effect of IVIG was observed during the pre-engraftment ( neutropenic ) and myelosuppression recovery phases . Most patients in these studies were undergoing allogeneic bone marrow transplantation , for which graft-versus-host disease and its treatment contribute to the rate of infection [ 18 ] . Intravenous immunoglobulin is not routinely used during autologous bone marrow transplantation or severely myelosuppressive therapy because prevention of graft-versus-host disease is unnecessary . Because IVIG prevents infection after allogeneic bone marrow transplantation , it might also do so in other patients undergoing intense myelosuppression and thus may serve as a general prophylactic agent for infections . Intravenous immunoglobulin is expensive and thus should not be used indiscriminately . We design ed a prospect i ve study that r and omized patients who were expected to develop severe and sustained myelosuppression to receive IVIG or no treatment . We specifically wished to determine whether IVIG could reduce the incidence of severe infections in patients with neutropenia but without allogeneic cofactors such as graft-versus-host disease . We therefore sought to determine whether the benefits of IVIG after allogeneic bone marrow transplantation occur as a direct effect of the drug or as an indirect result of a reduced incidence of graft-versus-host disease . Methods Study Design We conducted a stratified , r and omized comparison of patients who either underwent autologous bone marrow transplantation or received substantial myelosuppressive therapy for acute leukemia or other malignant conditions . The protocol and consent forms were approved by the Institutional Review Boards of the three participating institutions : Baylor University Medical Center , Dallas , Texas ; The University of Louisville , Louisville , Kentucky ; and V and erbilt University , Nashville , Tennessee . Patients were stratified for treatment ( autologous bone marrow transplantation or
Output:
| When polyvalent immunoglobulins or hyperimmune cytomegalovirus (CMV)-IVIG was compared to control for HSCT , there was no difference in all-cause mortality .
Polyvalent immunoglobulins significantly reduced the risk for interstitial pneumonitis but increased the risk for veno-occlusive disease and adverse events .
In LPD , no benefit in terms of mortality IVIG could be demonstrated but there was a decrease in clinical ly and microbiologically documented infections .
AUTHORS ' CONCLUSIONS In patients undergoing HSCT , routine prophylaxis with IVIG is not supported . |
MS213231 | ***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 Many individuals are advised to adhere to specific diet plans for their personal health ; hence , it is important that tools are available to support these behaviors . Smartphone applications ( apps ) may assist health care professionals in educating their clients on specific dietary modifications . This pilot study focused on a single dietary modification , reducing sodium intake , to determine whether a commercial health app is useful for promoting dietary change . METHODS Thirty healthy adults ( age 34.4 ± 15.7 y ; body mass index 25.6 ± 4.3 kg/m2 ) were recruited from a university community and completed this 4-wk r and omized parallel trial . Participants were instructed to reduce their sodium intake to ≤2300 mg/d by using the MyFitnessPal app to receive feedback on sodium content of foods or by paper tallying of estimated sodium intake . The predicted 24-h sodium excretion , estimated using the ratio of sodium to creatinine from the first morning urine void , and participant satisfaction were the main outcomes measured . RESULTS The change in the predicted 24-h sodium excretion differed between groups : -838 ± 1093 and + 236 ± 1333 mg/24 h predicted for the app and journal groups , respectively ( P = 0.010 ) . Moreover , participants in the app group reported significantly greater satisfaction with their method of diet tracking than the journal group ( P = 0.001 ) . CONCLUSIONS These data suggest that smartphone apps have the potential to facilitate the implementation of dietary advice . This was a small pilot study with limited scope , and more research is necessary to determine the value of smartphone apps for facilitating dietary change Background Mobile apps present a potentially cost-effective tool for delivering behavior change interventions at scale , but no known studies have tested the efficacy of apps as a tool to specifically increase vegetable consumption among overweight adults . Objective The purpose of this pilot study was to assess the initial efficacy and user acceptability of a theory-driven mobile app to increase vegetable consumption . Methods A total of 17 overweight adults aged 42.0 ( SD 7.3 ) years with a body mass index ( BMI ) of 32.0 ( SD 3.5 ) kg/m2 were r and omized to the use of Vegethon ( a fully automated theory-driven mobile app enabling self-monitoring of vegetable consumption , goal setting , feedback , and social comparison ) or a wait-listed control condition . All participants were recruited from an ongoing 12-month weight loss trial ( parent trial ) . Research ers who performed data analysis were blinded to condition assignment . The primary outcome measure was daily vegetable consumption , assessed using an adapted version of the vali date d Harvard Food Frequency Question naire administered at baseline and 12 weeks after r and omization . An analysis of covariance was used to assess differences in 12-week vegetable consumption between intervention and control conditions , controlling for baseline . App usability and satisfaction were measured via a 21-item post-intervention question naire . Results Using intention-to-treat analyses , all enrolled participants ( intervention : 8 ; control : 9 ) were analyzed . Of the 8 participants r and omized to the intervention , 5 downloaded the app and logged their vegetable consumption a mean of 0.7 ( SD 0.9 ) times per day , 2 downloaded the app but did not use it , and 1 never downloaded it . Consumption of vegetables was significantly greater among the intervention versus control condition at the end of the 12-week pilot study ( adjusted mean difference : 7.4 servings ; 95 % CI 1.4 - 13.5 ; P=.02 ) . Among secondary outcomes defined a priori , there was significantly greater consumption of green leafy vegetables , cruciferous vegetables , and dark yellow vegetables ( adjusted mean difference : 2.6 , 1.6 , and 0.8 servings ; 95 % CI 0.1 - 5.0 , 0.1 - 3.2 , and 0.3 - 1.4 ; P=.04 , P=.04 , and P=.004 , respectively ) . Participants reported positive experiences with the app , including strong agreement with the statements “ I have found Vegethon easy to use ” and “ I would recommend Vegethon to a friend ” ( mean 4.6 ( SD 0.6 ) and 4.2 ( SD 0.8 ) , respectively , ( on a 5-point scale ) . Conclusions Vegethon demonstrated initial efficacy and user acceptability . A mobile app intervention may be useful for increasing vegetable consumption among overweight adults . The small sample size prevented precise estimates of effect sizes . Given the improved health outcomes associated with increases in vegetable consumption , these findings indicate the need for larger , longer-term evaluations of Vegethon and similar technologies among overweight adults and other suitable target groups . Trial Registration Clinical Trials.gov NCT01826591 ; https:// clinical trials.gov/ct2/show/NCT01826591 ( Archived by WebCite at http://www.webcitation.org/6hYDw2AOB Background Conventional face-to-face weight loss and weight control programs are very labor intensive for both the patient and the provider . It is unclear to what extent conventional programs can be ( partially ) completed by mobile health ( mHealth ) apps . Objective The aim of this study was to compare the effectiveness of different weight loss programs using a combination of conventional and mobile programs among adults who are overweight ( body mass index [ BMI ] > 29 kg/m² ) . Methods A single-blinded r and omized controlled trial among obese adults was performed from September 2015 to March 2016 . The study took place in Leuven , Belgium . Of the 102 eligible ( BMI > 29 kg/m² ) adults , 81 ( 79 % ) completed the study . The three intervention groups consisted of a conventional face-to-face weight loss program , a weight loss app program ( app group ) , and a partial face-to-face and partial app program ( combi group ) . All intervention groups received the same advice from a dietician and a physical activity coach during a 12-week period . The control group did not receive any information during the same period . Primary outcomes were weight reduction ( 5 % decrease of baseline weight in kg ) , BMI , metabolic risk factors , dietary pattern , and physical activity . Results Significant more participants in all three intervention groups lost at least 5 % or more of their weight at baseline compared with the control group . No significant difference was found between the combi group and the conventional group . A trend was found that more participants in the combi group lost 5 % or more compared with the app group ( 19 % ) , P=.06 . A significant time x group effect was found for BMI and metabolic risk factors , with the control group having the worst results and the combi group being significantly better with regard to BMI compared with the app group . No significant group x time effects were found for the intake of different food and drinks and moderate to vigorous physical activity ( MVPA ) . Conclusions The results of this study show that a conventional weight loss program could partially be completed with an mHealth program without affecting the effectiveness . Trial Registration Clinical trials.gov NCT02595671 ; https:// clinical trials.gov/ct2/show/NCT02595671 ( Archived by WebCite at http://www.webcitation.org/6w1H0x1Q6 Background Obesity is a growing global issue that is linked to cognitive and psychological deficits . Objective This preliminary study investigated the efficacy of training to improve inhibitory control ( IC ) , a process linked to overeating , on consumption and cognitive control factors . Methods This study utilized a multisession mobile phone – based intervention to train IC in an overweight and obese population using a r and omized waitlist-control design . A combination of self- assessment question naires and psychophysiological measures was used to assess the efficacy of the intervention in terms of improved general IC and modified food consumption after training . Attitudes toward food were also assessed to determine their mediating role in food choices . A total of 58 participants ( 47 female ) completed 2 assessment sessions 3 weeks apart , with 2 weeks of intervention training for the training group during this time . The groups did not differ in baseline demographics including age , body mass index , and inhibitory control . Results Inhibitory control ability improved across the training sessions , with increases in P3 amplitude implying increased cognitive control over responses . Inhibitory control training was associated with increased healthy and reduced unhealthy food consumption in a taste test and in the week following training , as measured by the Healthy Eating Quiz and the food consumption test . Cognitive restraint was enhanced after training for the training but not the waitlist condition in the Three-Factor Eating Question naire , implying that attempts to avoid unhealthy foods in the future will be easier for the training group participants . Conclusions Inhibitory control training delivered via a purpose - design ed mobile phone app is easy to complete , is convenient , and can increase cognitive restraint and reduce unhealthy food consumption . Trial Registration Australian New Zeal and Clinical Trials Registry ACTRN12616000263493 ; http://www.ANZCTR.org.au/ACTRN12616000263493.aspx ( Archived by WebCite at http://www.webcitation.org/6ioHjGING Background Growing evidence shows that fixed , nonpersonalized daily step goals can discourage individuals , result ing in unchanged or even reduced physical activity . Objective The aim of this r and omized controlled trial ( RCT ) was to evaluate the efficacy of an automated mobile phone – based personalized and adaptive goal - setting intervention using machine learning as compared with an active control with steady daily step goals of 10,000 . Methods In this 10-week RCT , 64 participants were recruited via email announcements and were required to attend an initial in-person session . The participants were r and omized into either the intervention or active control group with a one-to-one ratio after a run-in period for data collection . A study -developed mobile phone app ( which delivers daily step goals using push notifications and allows real-time physical activity monitoring ) was installed on each participant ’s mobile phone , and participants were asked to keep their phone in a pocket throughout the entire day . Through the app , the intervention group received fully automated adaptively personalized daily step goals , and the control group received constant step goals of 10,000 steps per day . Daily step count was objective ly measured by the study -developed mobile phone app . Results The mean ( SD ) age of participants was 41.1 ( 11.3 ) years , and 83 % ( 53/64 ) of participants were female . The baseline demographics between the 2 groups were similar ( P>.05 ) . Participants in the intervention group ( n=34 ) had a decrease in mean ( SD ) daily step count of 390 ( 490 ) steps between run-in and 10 weeks , compared with a decrease of 1350 ( 420 ) steps among control participants ( n=30 ; P=.03 ) . The net difference in daily steps between the groups was 960 steps ( 95 % CI 90 - 1830 steps ) . Both groups had a decrease in daily step count between run-in and 10 weeks because interventions were also provided during run-in and no natural baseline was collected . Conclusions The results showed the short-term efficacy of this intervention , which should be formally evaluated in a full-scale RCT with a longer follow-up period . Trial Registration Clinical Trials.gov : NCT02886871 ; https:// clinical trials.gov/ct2/show/NCT02886871 ( Archived by WebCite at http://www.webcitation.org/6wM1Be1Ng ) Background : Evidence on the efficacy of smartphone applications ( apps ) for reducing body weight and other measurements of adiposity sustainably is not conclusive . Objective : To evaluate the effect of adding an app for 3 months to traditional counselling on physical activity ( PA ) and a heart-healthy diet for the modification of measurements of adiposity at 3 and 12 months after intervention . Methods : This r and omised clinical trial included 833 subjects . The counselling and app group ( IG ) had 415 subjects , while 418 were included in the counselling only group ( CG ) . The primary outcome was adiposity measurements at 3 and 12 months after intervention . The secondary outcome was the effect of the intervention by sex . Intervention : Counselling on a heart-healthy diet and PA was given to both groups . The IG also received training in the use of a smartphone app design ed to promote a heart-healthy diet and PA , and this group was given access to this application for 3 months . Outcome measurements included waist circumference ( WC ) , body mass index ( BMI ) and Clínica Universidad de Navarra – body adiposity estimator ( CUN-BAE ) . Results : In the IG at 12 months , the following decreased : WC −0.72 cm ( 95 % confidence interval [ CI ] : −2.35 to −0.02 ) and CUN-BAE −0.35 ( 95 % CI : −0.63 to −0.06 ) . These decreases were only observed in women . After baseline adjustment , the beneficial effect was maintained in the IG compared to the CG at 12 months in terms of WC ( −0.67 ; 95 % CI : −0.29 to −0.02 ) and CUN-BAE ( −0.57 ; 95 % CI : −1.10 to −0.04 ) , but only in women . Conclusions : An intervention of nutritional counselling and PA plus the smartphone app with personalised recommendations compared to CG showed beneficial results in terms of reduction of abdominal obesity and the percentage of body fat in women , but not in men Background Mobile applications ( apps ) have been heralded as transformative tools to deliver behavioral health interventions at scale , but few have been tested in rigorous r and omized controlled trials . We tested
Output:
| However , there was little evidence of changed behavior or health outcomes .
There was no strong evidence in support of the effectiveness of mobile apps in improving health behaviors or outcomes because few studies found significant differences between the app and control groups . |
MS213232 | ***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: Background . Osteosarcoma is a highly malignant bone tumour . After the second relapse , the 12-month postrelapse disease-free survival ( PRDFS ) rate decreases below 20 % . Oral Etoposide is often used in clinical practice after surgery as an “ adjuvant ” outside any protocol and with only limited evidence of improved survival . Viscum album fermentatum Pini ( Viscum ) is an extract of mistletoe plants grown on pine trees for subcutaneous ( sc ) injection with immunomodulatory activity . Methods . Encouraged by preliminary findings , we conducted a study where osteosarcoma patients free from disease after second metastatic relapse were r and omly assigned to Viscum sc or Oral Etoposide . Our goal was to compare 12-month PRDFS rates with an equivalent historical control group . Results . Twenty patients have been enrolled , with a median age of 34 years ( range 11–65 ) and a median follow-up time of 38.5 months ( 3–73 ) . The median PRDSF is currently 4 months ( 1–47 ) in the Etoposide and 39 months ( 2–73 ) in the Viscum group . Patients getting Viscum reported a higher quality of life due to lower toxicity . Conclusion . Viscum shows promise as adjuvant treatment in prolonging PRDFS after second relapse in osteosarcoma patients . A larger study is required to conclusively determine efficacy and immunomodulatory mechanisms of Viscum therapy in osteosarcoma patients Two hundred and thirty five patients with osteosarcoma , aged less than 40 years , and treated by amputation or radiotherapy , were entered in a r and omised trial of two forms of adjuvant chemotherapy . A two drug regimen , namely vincristine 2 mg m-2 ( maximum 2 mg ) followed by methotrexate 200 mgm-2 , given every three weeks , was compared with a three drug regimen , comprising the same vincristine-methotrexate treatment , alternating every three weeks with doxorubicin 60 mg m-2 . Both regimens were continued for 54 weeks . Forty-one patients were excluded , most because of inadequate histology , leaving 194 patients for analysis . One hundred and seventy of these had immediate amputation , 14 were treated by a policy of radiotherapy , with surgery delayed for 9 months , provided no distant metastases had appeared , and 10 by a policy of radiotherapy only . Patients have been followed-up for between 26 and 94 months after entry to the trial . The 2- and 5-year survival rates were 48 % and 27 % . No significant difference in survival was observed between the two regimens , but toxicity was less with the two drug regimen BACKGROUND Based on pre clinical data for the antitumour effect of zoledronate in osteosarcoma , we assessed whether zoledronate combined with chemotherapy and surgery improved event-free survival in children and adults with osteosarcoma . METHODS In this r and omised , multicentre , open-label , phase 3 trial ( OS2006 ) , patients aged between 5 years and 50 years with newly diagnosed high- grade osteosarcoma were r and omly assigned to receive st and ard chemotherapy with or without ten zoledronate intravenous infusions ( four preoperative and six postoperative ) . Adults older than 25 years received 4 mg zoledronate per infusion , patients aged 18 - 25 years received 0·05 mg/kg for the first two infusions and 4 mg for the remaining eight infusions , and younger patients received 0·05 mg/kg per infusion . Chemotherapy comprised high-dose methotrexate based chemotherapy in patients younger than 18 years , and doxorubicin , ifosfamide , and cisplatin in adults older than 25 years ; patients aged 18 - 25 years were treated with either regime at the discretion of the treating centre . Balanced r and omisation between the two groups was done central ly with online r and omisation software , based on a minimisation algorithm taking into account centre , age , combined with chemotherapy regimen , and risk group ( resectable primary and no metastasis vs other ) . Patients and investigators were not masked to treatment assignment , but the endpoint adjudication committee members who review ed suspected early progressions were masked to group allocation . The primary endpoint was event-free survival , estimated from the r and omisation to the time of first failure ( local or distant relapse , progression , death ) or to the last follow-up visit for the patients in first complete remission , analysed on a modified intention-to-treat population , which excluded patients found not to have a malignant tumour after central review . Three interim analyses were planned . This trial is registered with Clinical Trials.gov , number NCT00470223 . FINDINGS Between April 23 , 2007 , and March 11 , 2014 , 318 patients , median age 15·5 years ( range 5·8 - 50·9 ) , were enrolled from 40 French centres ; of whom 158 were assigned to the control group ( chemotherapy alone ) and 160 to the zoledronate group , including 55 ( 17 % ) patients with definite metastases . The trial was stopped for futility after the second interim analysis . With a median follow-up of 3·9 years ( IQR 2·7 - 5·1 ) , 125 events occurred ( 55 in the control group and 70 in the with zoledronate group ) . Event-free survival at 3 years for all 315 r and omly assigned patients was 60·3 % ( 95 % CI 64·5 - 65·9 ) ; 3-year event-free survival was 63·4 % ( 55·2 - 70·9 ) for the control group and 57·1 % ( 48·8 - 65·0 ) for the zoledronate group . The risk of failure was not reduced and was even marginally higher in the zoledronate group than in the control group ( hazard ratio [ HR ] 1·36 [ 95 % CI 0·95 - 1·96 ] ; p=0·094 ) . No major increase in severe toxic effects of grade 3 or higher associated with zoledronate , barring expected hypocalcaemia ( 45 [ 29 % ] of 153 participants in the zoledronate group vs ten [ 6 % ] of 155 participants in the control group ; p<0·0001 ) and hypophosphataemia ( 61 [ 40 % ] of 151 in the zoledronate group vs 26 [ 17 % ] of 156 in the control group ; p<0·0001 ) . No significant difference in orthopaedic complications was noted between the two groups ( 27 in the control group and 29 in the zoledronate group ) . Two treatment-related deaths were reported ( one from cardiomyopathy in the control group and one from multiorgan failure in the zoledronate group before the first zoledronate infusion ) . INTERPRETATION From the results observed in this study , we do not recommend zoledronate in osteosarcoma patients . Further biological studies are required to underst and the discordance between the results of OS2006 trial and pre clinical data . FUNDING French National Cancer Institute ( INCa ) , Novartis , Chugai , Ligue Nationale contre le Cancer , Fédération Enfants et Santé , Société Française des Cancers et Leucémies de l'Enfant Summary Background We design ed the EURAMOS-1 trial to investigate whether intensified postoperative chemotherapy for patients whose tumour showed a poor response to preoperative chemotherapy ( ≥10 % viable tumour ) improved event-free survival in patients with high- grade osteosarcoma . Methods EURAMOS-1 was an open-label , international , phase 3 r and omised , controlled trial . Consenting patients with newly diagnosed , resectable , high- grade osteosarcoma aged 40 years or younger were eligible for r and omisation . Patients were r and omly assigned ( 1:1 ) to receive either postoperative cisplatin , doxorubicin , and methotrexate ( MAP ) or MAP plus ifosfamide and etoposide ( MAPIE ) using concealed permuted blocks with three stratification factors : trial group ; location of tumour ( proximal femur or proximal humerus vs other limb vs axial skeleton ) ; and presence of metastases ( no vs yes or possible ) . The MAP regimen consisted of cisplatin 120 mg/m2 , doxorubicin 37·5 mg/m2 per day on days 1 and 2 ( on weeks 1 and 6 ) followed 3 weeks later by high-dose methotrexate 12 g/m2 over 4 h. The MAPIE regimen consisted of MAP as a base regimen , with the addition of high-dose ifosfamide ( 14 g/m2 ) at 2·8 g/m2 per day with equidose mesna uroprotection , followed by etoposide 100 mg/m2 per day over 1 h on days 1–5 . The primary outcome measure was event-free survival measured in the intention-to-treat population . This trial is registered with Clinical Trials.gov , number NCT00134030 . Findings Between April 14 , 2005 , and June 30 , 2011 , 2260 patients were registered from 325 sites in 17 countries . 618 patients with poor response were r and omly assigned ; 310 to receive MAP and 308 to receive MAPIE . Median follow-up was 62·1 months ( IQR 46·6–76·6 ) ; 62·3 months ( IQR 46·9–77·1 ) for the MAP group and 61·1 months ( IQR 46·5–75·3 ) for the MAPIE group . 307 event-free survival events were reported ( 153 in the MAP group vs 154 in the MAPIE group ) . 193 deaths were reported ( 101 in the MAP group vs 92 in the MAPIE group ) . Event-free survival did not differ between treatment groups ( hazard ratio [ HR ] 0·98 [ 95 % CI 0·78–1·23 ] ) ; hazards were non-proportional ( p=0·0003 ) . The most common grade 3–4 adverse events were neutropenia ( 268 [ 89 % ] patients in MAP vs 268 [ 90 % ] in MAPIE ) , thrombocytopenia ( 231 [ 78 % in MAP vs 248 [ 83 % ] in MAPIE ) , and febrile neutropenia without documented infection ( 149 [ 50 % ] in MAP vs 217 [ 73 % ] in MAPIE ) . MAPIE was associated with more frequent grade 4 non-haematological toxicity than MAP ( 35 [ 12 % ] of 301 in the MAP group vs 71 [ 24 % ] of 298 in the MAPIE group ) . Two patients died during postoperative therapy , one from infection ( although their absolute neutrophil count was normal ) , which was definitely related to their MAP treatment ( specifically doxorubicin and cisplatin ) , and one from left ventricular systolic dysfunction , which was probably related to MAPIE treatment ( specifically doxorubicin ) . One suspected unexpected serious adverse reaction was reported in the MAP group : bone marrow infa rct ion due to methotrexate . Interpretation EURAMOS-1 results do not support the addition of ifosfamide and etoposide to postoperative chemotherapy in patients with poorly responding osteosarcoma because its administration was associated with increased toxicity without improving event-free survival . The results define st and ard of care for this population . New strategies are required to improve outcomes in this setting . Funding UK Medical Research Council , National Cancer Institute , European Science Foundation , St Anna Kinderkrebsforschung , Fonds National de la Recherche Scientifique , Fonds voor Wetenschappelijk Onderzoek-Vla and eren , Parents Organization , Danish Medical Research Council , Academy of Finl and , Deutsche Forschungsgemeinschaft , Deutsche Krebshilfe , Federal Ministry of Education and Research , Semmelweis Foundation , ZonMw ( Council for Medical Research ) , Research Council of Norway , Sc and inavian Sarcoma Group , Swiss Paediatric Oncology Group , Cancer Research UK , National Institute for Health Research , University College London Hospitals , and Biomedical Research Centre Following observation of the predictive value of the histologic extent of tumor cell destruction after preoperative chemotherapy for metastasis-free survival ( MFS ) in osteosarcoma , a r and omized study was undertaken with the aim of ( 1 ) sparing some patients the unpleasant side effects of highly toxic drugs like doxorubicin ( DOX ) and cisplatin ( CPDD ) by administering these drugs postoperatively only after poor response with a milder preoperative regimen , and ( 2 ) improving the prognosis of patients responding poorly to the initial treatment by use of a salvage chemotherapy postoperatively . The available patients were divided into two groups . Those in the study arm received a preoperative chemotherapy consisting of high-dose methotrexate ( HDMTX ) and the triple drug combination of bleomycin , cyclophosphamide , and dactinomycin ( BCD ) and were switched to DOX/CPDD postoperatively in case of poor response . DOX
Output:
| Conclusions We concluded that multi-drug regimens have a better effect on prolonging the PFS and OS of osteosarcoma patients , and the T12 protocol has a better effect on prolonging the PFS of osteosarcoma patients , particularly in combination with ifosfamide or vincristine .
The OS analysis showed that the T12 protocol plus vincristine or the T12 protocol with the removal of cisplatinum might be a better regimen for improving the OS of patients . |
MS213233 | ***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 Esophageal resection is associated with a high incidence of postoperative pneumonia . Respiratory complications account for almost half of the readmissions to the critical care unit . Postoperative complications can result in prolonged hospital stay and consequently increase healthcare costs . In cardiac surgery a preoperative inspiratory muscle training program has shown to prevent postoperative pneumonia and reduce length of hospital stay . While in some surgical centers inspiratory muscle training is already used in the preoperative phase in patients undergoing esophageal resection , the added value of this intervention on the reduction of pulmonary complications has not yet been investigated in large surgical population s other than cardiac surgery in a r and omized and controlled study design . Methods / Design The effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection will be studied in a single blind multicenter r and omized controlled trial ( the PREPARE study ) . In total 248 patients ( age > 18 years ) undergoing esophageal resection for esophageal cancer will be included in this study . They are r and omized to either usual care or usual care with an additional inspiratory muscle training intervention according to a high-intensity protocol which is performed with a tapered flow resistive inspiratory loading device . Patients have to complete 30 dynamic inspiratory efforts twice daily for 7 days a week until surgery with a minimum of 2 weeks . The starting training load will be aim ed to be 60 % of maximal inspiratory pressure and will be increased based on the rate of perceived exertion . The main study endpoint is the incidence of postoperative pneumonia . Secondary objectives are to evaluate the effect of preoperative inspiratory muscle training on length of hospital stay , duration of mechanical ventilation , incidence of other postoperative ( pulmonary ) complications , quality of life , and on postoperative respiratory muscle function and lung function . Discussion The PREPARE study is the first multicenter r and omized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection . Trial registration NCT01893008 BACKGROUND Aging results in a decline in the function of the respiratory muscles . Inspiratory muscle training is emerging as a possible intervention to attenuate the decline of respiratory muscles in the elderly . The aim of this study was to evaluate the efficacy of inspiratory muscle training on respiratory strength , diaphragm thickness , and diaphragmatic mobility in elderly women . METHODS This was a controlled , r and omized , and double-blind clinical trial , performed on 22 elderly women distributed in two groups , training ( TG ) and control ( CG ) . Over an 8-week period a moderate intensity inspiratory muscle training protocol was followed in the TG , while CG followed a sham protocol . In addition maximum expiratory and inspiratory pressure , mobility of the diaphragm and diaphragmatic thickness were evaluated by ultrasound . RESULTS After training , in TG maximal inspiratory pressure , maximal expiratory pressure , diaphragm thickness , and mobility increased by 37 % , 13 % , 11 % , and 9 % respectively , and their values were significantly higher than CG ( p < .005 , p = .013 , p = .001 , and p = .001 ) . CONCLUSION Inspiratory muscle training of moderate intensity improves respiratory muscle strength , diaphragm thickness , and diaphragm mobility in elderly women and it should be considered to minimize changes associated with senescence Our aim was to determine the minimal important difference ( MID ) for 6-min walk distance ( 6MWD ) and maximal cycle exercise capacity ( MCEC ) in patients with severe chronic obstructive pulmonary disease ( COPD ) . 1,218 patients enrolled in the National Emphysema Treatment Trial completed exercise tests before and after 4–6 weeks of pre-trial rehabilitation , and 6 months after r and omisation to surgery or medical care . The St George 's Respiratory Question naire ( domain and total scores ) and University of California San Diego Shortness of Breath Question naire ( total score ) served as anchors for anchor-based MID estimates . In order to calculate distribution-based estimates , we used the st and ard error of measurement , Cohen 's effect size and the empirical rule effect size . Anchor-based estimates for the 6MWD were 18.9 m ( 95 % CI 18.1–20.1 m ) , 24.2 m ( 95 % CI 23.4–25.4 m ) , 24.6 m ( 95 % CI 23.4–25.7 m ) and 26.4 m ( 95 % CI 25.4–27.4 m ) , which were similar to distribution-based MID estimates of 25.7 , 26.8 and 30.6 m. For MCEC , anchor-based estimates for the MID were 2.2 W ( 95 % CI 2.0–2.4 W ) , 3.2 W ( 95 % CI 3.0–3.4 W ) , 3.2 W ( 95 % CI 3.0–3.4 W ) and 3.3 W ( 95 % CI 3.0–3.5 W ) , while distribution-based estimates were 5.3 and 5.5 W. We suggest a MID of 26±2 m for 6MWD and 4±1 W for MCEC for patients with severe COPD AIM To investigate the effects of inspiratory muscle training ( IMT ) on functional capacity and balance , respiratory and peripheral muscle strength , pulmonary function , dyspnea , fatigue , depression , and quality of life in heart failure patients . METHODS A prospect i ve , r and omized controlled , double-blinded study . Thirty patients with heart failure ( NYHA II-III , LVEF<40 % ) were included . Sixteen patients received IMT at 40 % of maximal inspiratory pressure ( MIP ) , and 14 patients received sham therapy ( 15 % of MIP ) for 6 weeks . Functional capacity and balance , respiratory muscle strength , quadriceps femoris muscle strength , pulmonary function , dyspnea , fatigue , quality of life , and depression were evaluated . RESULTS Functional capacity and balance , respiratory and peripheral muscle strength , dyspnea , depression were significantly improved in the treatment group compared with controls ; quality of life and fatigue were similarly improved within groups ( p < 0.05 ) . Functional capacity ( 418.59 ± 123.32 to 478.56 ± 131.58 m , p < 0.001 ) , respiratory ( MIP = 62.00 ± 33.57 to 97.13 ± 32.63 cmH(2)O , p < 0.001 ) and quadriceps femoris muscle strength ( 240.91 ± 106.08 to 301.82 ± 111.86 N , p < 0.001 ) , FEV(1)% , FVC% and PEF% , functional balance ( 52.73 ± 3.15 to 54.25 ± 2.34 , p < 0.001 ) , functional dyspnea ( 2.27 ± 0.88 to 1.07 ± 0.79 , p < 0.001 ) , depression ( 11.47 ± 7.50 to 3.20 ± 4.09 , p < 0.001 ) , quality of life , fatigue ( 42.73 ± 11.75 to 29.07 ± 13.96 , p < 0.001 ) were significantly improved in the treatment group . Respiratory muscle strength ( MIP = 78.64 ± 35.95 to 90.86 ± 30.23 cmH(2)O , p = 0.001 ) , FVC% , depression ( 14.36 ± 9.04 to 9.50 ± 10.42 , p = 0.011 ) , quality of life and fatigue ( 42.86 ± 12.67 to 32.93 ± 15.87 , p = 0.008 ) were significantly improved in the control group . CONCLUSION The IMT improves functional capacity and balance , respiratory and peripheral muscle strength ; decreases depression and dyspnea perception in patients with heart failure . IMT should be included effectively in pulmonary rehabilitation programs Chronic renal failure can result in a variety of conditions leading to muscle weakness . We investigated inspiratory muscle ( IM ) performance and functional capacity in chronic renal failure before and after specific inspiratory muscle training ( SIMT ) . 9 men and 1 woman , ranging in age from 22 - 78 years , while on chronic hemodialysis received SIMT 3 times a week , for 3 months , while 10 others received sham training . Static inspiratory pressures , IM endurance and functional capacity were reduced in most subjects . Following SIMT , IM performance improved significantly and was associated with improved functional capacity , but not in the control group . We conclude that patients with chronic renal failure undergoing maintenance hemodialysis have reduced IM performance , and SIMT improves functional capacity BACKGROUND Exercise training increasingly is recommended as an important part of the management of cardiovascular disease . However , few studies have evaluated the effectiveness of exercise training in patients with chronic kidney disease ( CKD ) , and those that have included very selective population s. STUDY DESIGN Analysis of secondary outcomes of a r and omized controlled trial , with participants r and omly assigned to either lifestyle intervention or usual care ( control ) . SETTING & PARTICIPANTS Patients with CKD stages 3 to 4 and one or more uncontrolled cardiovascular risk factor were recruited from an outpatient clinic at a large tertiary hospital . INTERVENTION Lifestyle intervention included access to multidisciplinary care through a nurse practitioner-led CKD clinic , exercise training , and a lifestyle program . The exercise training was a 2-phased program in which participants received 8 weeks of supervised training before commencing 10 months of home-based training . OUTCOMES & MEASUREMENTS Efficacy , as assessed by metabolic equivalent tasks ( METs ) , 6-minute walk distance , Timed Get-Up- and -Go test , grip strength , and anthropomorphic measures ; adherence , as assessed by self-reported physical activity ; and safety , as assessed by reported serious adverse events , were recorded . RESULTS 83 patients were r and omly assigned and 72 patients completed follow-up testing ( intervention , n=36 ; control , n=36 ) . The intervention result ed in a significant improvement in METs ( pre , 7.2±3.3 ; post , 9.7±3.6 ) , 6-minute walk distance ( pre , 485±110 m ; post , 539±82 m ) , and body mass index ( pre , 32.5±6.7kg/m(2 ) ; post , 31.9±7.3kg/m(2 ) ) . Reported physical activity levels significantly increased in the intervention group at 6 months , but decreased at 12 months . There were no serious adverse events related to the exercise training . LIMITATIONS This study was not powered to evaluate the safety of exercise training on serious adverse events . CONCLUSIONS The findings from the present study suggest that an exercise program that includes a supervised and home-based training phase is effective , adhered to , and safe in patients with CKD Resistance respiratory muscle training ( RRMT ) increases respiratory muscle and swimming performance at depths down to 17 msw . It is unknown if RRMT improves swimming performance at greater depths and if the improvements are associated with a reduced work of breathing ( WOB ) , altered respiratory mechanics and /or improved respiratory muscle performance . Eight male subjects ( 30.3 ± 6.0 years ) were tested swimming underwater in a hyperbaric chamber at 37 m of depth against a pre-determined load ( 70 % $ $ \dot{V}_{{{\text{O } } _ { 2 } } } $ $ ) until exhausted . End expiratory lung volume ( EELV ) was determined by subtracting inspiratory capacity from total lung capacity throughout the swims . The mechanical WOB on the lung was calculated as the integrated product of the transpulmonary pressure and ventilatory flow . Maximal expiratory ( PEMAX ) and inspiratory pressures ( PIMAX ) were measured pre- and post-RRMT . RRMT was performed every 30 s against spring loaded inspiratory and expiratory valves 30 min/day , 5 days/week , for 4 weeks . RRMT increased PIMAX and PEMAX by 40 % ( 110 ± 11 cmH2O ( SD ) vs. 155 ± 22 , p < 0.001 ) and 30 % ( 148 ± 33 cmH2O vs. 192 ± 49 , p < 0.001 ) , respectively , respiratory endurance by 75 % ( 19.7 ± 15.4 min vs. 34.4 ± 27.3 , p = 0.010 ) , and swimming endurance by 87 % ( 26.4 ± 9.7 min vs. 49.4 ± 21.6 , p = 0.004 ) . The longer swimming time was associated with reduced $ $ \dot{V}_{\text{E } } $ $ and $ $ \dot{V}_{\text{A } } $ $ ( p < 0.001
Output:
| Significant benefits in lung function and quality of life were also identified .
In patients with chronic renal failure on dialysis , inspiratory muscle training with a fixed load significantly improves respiratory muscle strength , functional capacity , lung function and quality of life .
de Medeiros AIC , Fuzari HKB , Rattesa C , Br and ão DC , de Melo Marinho PÉ ( 2017 ) Inspiratory muscle training improves respiratory muscle strength , functional capacity and quality of life in patients with chronic kidney disease : a systematic review . |
MS213234 | ***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 eight-item Patient Health Question naire depression scale ( PHQ-8 ) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies . Our objectives were to assess the PHQ-8 as a depression measure in a large , epidemiological population -based study , and to determine the comparability of depression as defined by the PHQ-8 diagnostic algorithm vs. a PHQ-8 cutpoint > or = 10 . METHODS R and om-digit-dialed telephone survey of 198,678 participants in the 2006 Behavioral Risk Factor Surveillance Survey ( BRFSS ) , a population -based survey in the United States . Current depression as defined by either the DSM-IV based diagnostic algorithm ( i.e. , major depressive or other depressive disorder ) of the PHQ-8 or a PHQ-8 score > or = 10 ; respondent sociodemographic characteristics ; number of days of impairment in the past 30 days in multiple domains of health-related quality of life ( HRQoL ) . RESULTS The prevalence of current depression was similar whether defined by the diagnostic algorithm or a PHQ-8 score > or = 10 ( 9.1 % vs. 8.6 % ) . Depressed patients had substantially more days of impairment across multiple domains of HRQoL , and the impairment was nearly identical in depressed groups defined by either method . Of the 17,040 respondents with a PHQ-8 score > or = 10 , major depressive disorder was present in 49.7 % , other depressive disorder in 23.9 % , depressed mood or anhedonia in another 22.8 % , and no evidence of depressive disorder or depressive symptoms in only 3.5 % . LIMITATIONS The PHQ-8 diagnostic algorithm rather than an independent structured psychiatric interview was used as the criterion st and ard . CONCLUSIONS The PHQ-8 is a useful depression measure for population -based studies , and either its diagnostic algorithm or a cutpoint > or = 10 can be used for defining current depression Background There is increasing recognition of mindfulness and mindfulness training as a way to decrease stress and increase psychological functioning . Purpose The aims of this study were to examine the effects of mindfulness stress reduction training on perceived stress and psychological well-being and to examine if changes in mindfulness mediate intervention effects on these outcomes . Methods Seventy women and one man with a previous cancer diagnosis ( mean age 51.8 years , st and ard deviation = 9.86 ) were r and omized into an intervention group or a wait-list control group . The intervention consisted of an 8-week mindfulness training course . Results Compared to participants in the control group , participants in the mindfulness training group had significantly decreased perceived stress and posttraumatic avoidance symptoms and increased positive states of mind . Those who participated in the intervention reported a significant increase in scores on the five-facet mindfulness question naire ( FFMQ ) when compared to controls . The increase in FFMQ score mediated the effects of the intervention on perceived stress , posttraumatic avoidance symptoms , and positive states of mind . Conclusions This study indicates that the improvements in psychological well-being result ing from mindfulness stress reduction training can potentially be explained by increased levels of mindfulness as measured with the FFMQ . The importance of these findings for future research in the field of mindfulness is discussed Sleep disturbance is a very common problem for cancer patients that has largely not been addressed in the clinical intervention literature . Mindfulness meditation has demonstrated clinical benefits for a variety of patient population s in other areas of functioning . This study examined the effects of an 8-week Mindfulness-Based Stress Reduction ( MBSR ) program on the sleep quality of a heterogeneous sample of 63 cancer patients . Overall sleep disturbance was significantly reduced ( p < .001 ) and participants reported that their sleep quality had improved ( p < .001 ) . There was also a significant reduction in stress ( p < .001 ) , mood disturbance ( p = .001 ) , and fatigue ( p < .001 ) . The associations among these changes and implication s for improving quality of life of cancer patients are discussed BACKGROUND A self-rating inventory has been developed to measure DSM-IV and ICD-10 diagnoses of major ( moderate to severe ) depression by the patients ' self-reported symptoms . This Major Depression Inventory ( MDI ) can be scored both according to the DSM-IV and the ICD-10 algorithms for depressive symptomatology and according to severity scales by the simple total sum of the items . METHODS The Schedule for Clinical Assessment in Neuropsychiatry ( SCAN ) was used as index of validity for the clinician 's DSM-IV and ICD-10 diagnosis of major ( moderate to severe ) depression . The sensitivity and specificity of MDI was assessed in a sample of 43 subjects covering a spectrum of depressive symptoms . RESULTS The sensitivity of the MDI algorithms for major depression varied between 0.86 and 0.92 . The specificity varied between 0.82 and 0.86 . When using the total score of MDI the optimal cut-off score was estimated 26 and the total score was shown to be a sufficient statistic . LIMITATIONS The sample of subjects was limited . Patients with psychotic depression were not included . CONCLUSION The MDI was found to have a sensitivity and specificity which is acceptable . The question naire is brief and can be scored diagnostically by the DSM-IV and ICD-10 algorithms as well as by its simple total score OBJECTIVES Considerable morbidity persists among survivors of breast cancer ( BC ) including high levels of psychological stress , anxiety , depression , fear of recurrence , and physical symptoms including pain , fatigue , and sleep disturbances , and impaired quality of life . Effective interventions are needed during this difficult transitional period . METHODS We conducted a r and omized controlled trial of 84 female BC survivors ( Stages 0-III ) recruited from the H. Lee Moffitt Cancer and Research Institute . All subjects were within 18 months of treatment completion with surgery and adjuvant radiation and /or chemotherapy . Subjects were r and omly assigned to a 6-week Mindfulness-Based Stress Reduction ( MBSR ) program design ed to self-regulate arousal to stressful circumstances or symptoms ( n=41 ) or to usual care ( n=43 ) . Outcome measures compared at 6 weeks by r and om assignment included vali date d measures of psychological status ( depression , anxiety , perceived stress , fear of recurrence , optimism , social support ) and psychological and physical subscales of quality of life ( SF-36 ) . RESULTS Compared with usual care , subjects assigned to MBSR(BC ) had significantly lower ( two-sided p<0.05 ) adjusted mean levels of depression ( 6.3 vs 9.6 ) , anxiety ( 28.3 vs 33.0 ) , and fear of recurrence ( 9.3 vs 11.6 ) at 6 weeks , along with higher energy ( 53.5 vs 49.2 ) , physical functioning ( 50.1 vs 47.0 ) , and physical role functioning ( 49.1 vs 42.8 ) . In stratified analyses , subjects more compliant with MBSR tended to experience greater improvements in measures of energy and physical functioning . CONCLUSIONS Among BC survivors within 18 months of treatment completion , a 6-week MBSR(BC ) program result ed in significant improvements in psychological status and quality of life compared with usual care For people at risk of depressive relapse , mindfulness-based cognitive therapy ( MBCT ) has an additive benefit to usual care ( H. F. Coelho , P. H. Canter , & E. Ernst , 2007 ) . This study asked if , among patients with recurrent depression who are treated with antidepressant medication ( ADM ) , MBCT is comparable to treatment with maintenance ADM ( m-ADM ) in ( a ) depressive relapse prevention , ( b ) key secondary outcomes , and ( c ) cost effectiveness . The study design was a parallel 2-group r and omized controlled trial comparing those on m-ADM ( N = 62 ) with those receiving MBCT plus support to taper/discontinue antidepressants ( N = 61 ) . Relapse/recurrence rates over 15-month follow-ups in MBCT were 47 % , compared with 60 % in the m-ADM group ( hazard ratio = 0.63 ; 95 % confidence interval : 0.39 to 1.04 ) . MBCT was more effective than m-ADM in reducing residual depressive symptoms and psychiatric comorbidity and in improving quality of life in the physical and psychological domains . There was no difference in average annual cost between the 2 groups . Rates of ADM usage in the MBCT group was significantly reduced , and 46 patients ( 75 % ) completely discontinued their ADM . For patients treated with ADM , MBCT may provide an alternative approach for relapse prevention Statistical procedures for missing data have vastly improved , yet misconception and unsound practice still abound . The authors frame the missing- data problem , review methods , offer advice , and raise issues that remain unresolved . They clear up common misunderst and ings regarding the missing at r and om ( MAR ) concept . They summarize the evidence against older procedures and , with few exceptions , discourage their use . They present , in both technical and practical language , 2 general approaches that come highly recommended : maximum likelihood ( ML ) and Bayesian multiple imputation ( MI ) . Newer developments are discussed , including some for dealing with missing data that are not MAR . Although not yet in the mainstream , these procedures may eventually extend the ML and MI methods that currently represent the state of the art Background Surgeons , along with the Centers for Disease Control and Prevention , emphasize the importance of managing symptoms and improving the quality of life of cancer survivors . A 2008 meta- analysis of mindfulness-based stress reduction ( MBSR ) concluded that this technique might improve patients ’ adjustment to their disease . However , r and omized controlled trials using st and ardized measures for evaluating MBSR are limited . The primary objective of this study was to evaluate , using valid and reliable measures , the effects of a unique , interactive , 8-week cancer recovery and wellness program on symptoms and quality of life of female cancer survivors . Methods Sixty-eight female cancer patients were r and omized into either an intervention or waitlisted control group . Patients were evaluated using the Symptoms Checklist ( SCL-90-R ) , the European Organization for Research and Treatment of Cancer Quality of Life Question naire ( EORTC QLQ-30 ) , and the Symptoms of Stress Inventory ( SOSI ) . Results Of the participants , 70.6 % were breast cancer survivors . Mean age was 57.5 years ( treatment group ) and 56.4 years ( control group ) . Between-group demographic differences were not significant ( P > 0.6 ) . The treatment group improved significantly on the EORTC QLQ-30 ( P = 0.005 ) , on six of the eight SOSI subscales ( P ≤ 0.049 ) , and on both SCL-90-R subscales ( P ≤ 0.023 ) , while the control group did not improve on any of these measures ( P > 0.2 ) . Conclusion The MBSR-based cancer recovery and wellness intervention improved the symptoms and quality of life of this largely breast cancer survivor population across a variety of cancer symptoms and quality -of-life measures 424 BMJ | 24 FEBRUARY 2007 | VOLUME 334 Almost all studies have some missing observations . Yet textbooks and software commonly assume that data are complete , and the topic of how to h and le missing data is not often discussed outside statistics journals . There are many types of missing data and different reasons for data being missing . Both issues affect the analysis . Some examples are : ( 1 ) In a postal question naire survey not all the selected individuals respond ; ( 2 ) In a r and omised trial some patients are lost to follow-up before the end of the study ; ( 3 ) In a multicentre study some centres do not measure a particular variable ; ( 4 ) In a study in which patients are assessed frequently some data are missing at some time points for unknown reasons ; ( 5 ) Occasional data values for a variable are missing because some equipment failed ; ( 6 ) Some laboratory sample s are lost in transit or technically unsatisfactory ; ( 7 ) In a magnetic resonance imaging study some very obese patients are excluded as they are too large for the machine ; ( 8) In a study assessing quality of life some patients die during the follow-up period OBJECTIVE This study explores satisfaction and changes in well-being in cancer patients following mindfulness-based stress reduction training . METHOD Data were collected in 47 cancer patients before and after the training , and also 1 year later . St and ardized question naires were used to measure quality of life , joy in life , mood disturbances ( depression , anger , vigor , fatigue , and tension ) , meaning in life and physical symptoms . RESULTS Participants were highly satisfied and said they had reached their goals with the training . The results show that directly after the training patients reported a better quality of life , more joy in life , less tension , and fewer physical symptoms . These effects appeared even stronger at follow-up . A year after the training a decrease was also found in depression , anger , vigor and total mood disturbance . No changes could be established for meaning in life and fatigue . Effect sizes varied between 0.28 and 0.60 , indicating small-to-moderate changes . CONCLUSION Mindfulness training potentially supports cancer patients in h and ling the stress due to their life-threatening disease and increases their well-being . Several suggestions for further research are discussed . PRACTICE IMPLICATION S Mindfulness training provides cancer patients with tools to deal with their limitations and worries , both during and after their treatment OBJECTIVE Major depression is the most common psychiatric disorder among breast cancer patients and is associated with substantial impair
Output:
| While the overall quality of existing clinical trials varies considerably , there appears to be some positive evidence from relatively high- quality RCTs to support the use of MBT for cancer patients and survivors with symptoms of anxiety and depression |
MS213235 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Abstract Objective . The effect of probiotics on IBS symptoms has been mixed , but remains an intriguing treatment option with appeal to the patient . Material and methods . Patients fulfilling the Rome II criteria were r and omized double-blind to a daily intake of 500 ml of fermented milk containing at least 5 × 107 CFU/ml of Lactobacillus paracasei ssp paracasei F19 , Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 or an equal volume of acidified milk for 8 weeks . Symptoms were assessed at baseline and weekly using a disease-specific vali date d symptom rating scale ( IBS-SSI ) . The predefined primary outcome measure was patient reported adequate symptom relief . Adherence to study protocol were assessed by performing stool sample s at the of the treatment period . Results . Eight-one patients were screened . Sixty-four patients were r and omized ; 18 patients did not complete the study due to protocol violations or withdrew due to lack of effect . Fifty-two patients ( 13 males ) completed the study as per protocol ; mean age was 51.3 years ( range 29–67 ) . The proportion of patients reporting adequate symptom relief increased in both patient groups , but there was not any statistical difference between the groups . IBS-SSI scores did not differ statistically between the groups at the end of the treatment period , but improved during the study period in both groups . Conclusions . During this 8-week trial gastrointestinal symptoms improved . However , there was no difference between treatment with fermented milk containing probiotics or acidified milk . The effect of probiotics on IBS symptoms remains uncertain and further studies are warranted Introduction . Although combination therapy with herbal medicine and probiotics is gaining popularity for controlling diarrhea-dominant irritable bowel syndrome ( D-IBS ) symptoms , few studies have investigated its clinical effects . Material s and Methods . Fifty-three patients with D-IBS were r and omly allocated into 1 of the following 4 groups : herbal medicine ( Gwakhyangjeonggisan ; GJS ) plus probiotics ( Duolac7S ; DUO ) , GJS plus placebo DUO , placebo GJS plus DUO , and placebo GJS plus placebo DUO . The study period consisted of a 2-week run-in , 8 weeks of administration , and 2 weeks of follow-up . The primary outcomes were weekly adequate relief ( AR ) of overall IBS symptoms and the proportion of responders ( PR ) during the administration period . The secondary outcomes included individual IBS symptoms , stool assessment , and quality of life . Changes of intestinal microbiota and intestinal permeability were also analyzed . Results and Discussion . Weekly AR was not different among the 4 groups throughout the treatment period . However , the 3 treatment groups exhibited significant improvements in PR compared to the findings in the placebo group . In the intestinal microbiota assessment , herbal medicine and probiotics synergistically increased beneficial bacteria counts . Conclusion . Combination therapy with herbal medicine and probiotics appears to relieve overall IBS symptoms by synergistically increasing beneficial intestinal microbe counts AIM To evaluate the effects of a combination probiotic on symptoms and colonic transit in patients with irritable bowel syndrome ( IBS ) and significant bloating . METHODS Forty-eight patients with Rome II IBS were r and omized in a parallel group , double-blind design to placebo or VSL # 3 twice daily ( 31 patients received 4 weeks and 17 patients 8 weeks of treatment ) . Pre- and post-treatment colonic transit measurements were performed using scintigraphy with (111)In charcoal . Symptoms were summarized as an average daily score for the entire period of treatment and separately for the first 4 weeks of treatment . Weekly satisfactory relief of abdominal bloating was assessed . RESULTS Treatment with VSL # 3 was associated with reduced flatulence over the entire treatment period ( placebo 39.5 + /- 2.6 vs VSL # 3 29.7 + /- 2.6 , P = 0.011 ) ; similarly , during the first 4 weeks of treatment , flatulence scores were reduced ( placebo 40.1 + /- 2.5 vs VSL # 3 30.8 + /- 2.5 , P = 0.014 ) . Proportions of responders for satisfactory relief of bloating , stool-related symptoms , abdominal pain and bloating scores were not different . Colonic transit was retarded with VSL # 3 relative to placebo ( colon geometric center 2.27 + /- 0.20 vs 2.83 + /- 0.19 , P = 0.05 respectively ) . CONCLUSION VSL # 3 reduces flatulence scores and retards colonic transit without altering bowel function in patients with IBS and bloating Long-term dietary intake influences the structure and activity of the trillions of microorganisms residing in the human gut , but it remains unclear how rapidly and reproducibly the human gut microbiome responds to short-term macronutrient change . Here we show that the short-term consumption of diets composed entirely of animal or plant products alters microbial community structure and overwhelms inter-individual differences in microbial gene expression . The animal-based diet increased the abundance of bile-tolerant microorganisms ( Alistipes , Bilophila and Bacteroides ) and decreased the levels of Firmicutes that metabolize dietary plant polysaccharides ( Roseburia , Eubacterium rectale and Ruminococcus bromii ) . Microbial activity mirrored differences between herbivorous and carnivorous mammals , reflecting trade-offs between carbohydrate and protein fermentation . Foodborne microbes from both diets transiently colonized the gut , including bacteria , fungi and even viruses . Finally , increases in the abundance and activity of Bilophila wadsworthia on the animal-based diet support a link between dietary fat , bile acids and the outgrowth of microorganisms capable of triggering inflammatory bowel disease . In concert , these results demonstrate that the gut microbiome can rapidly respond to altered diet , potentially facilitating the diversity of human dietary lifestyles BACKGROUND : Probiotic bacteria exhibit a variety of properties , including immunomodulatory activity , which are unique to a particular strain . Thus , not all species will necessarily have the same therapeutic potential in a particular condition . We have preliminary evidence that Bifidobacterium infantis 35624 may have utility in irritable bowel syndrome ( IBS ) . OBJECTIVES : This study was design ed to confirm the efficacy of the probiotic bacteria B. infantis 35624 in a large-scale , multicenter , clinical trial of women with IBS . A second objective of the study was to determine the optimal dosage of probiotic for administration in an encapsulated formulation . METHODS : After a 2-wk baseline , 362 primary care IBS patients , with any bowel habit subtype , were r and omized to either placebo or freeze-dried , encapsulated B. infantis at a dose of 1 × 106 , 1 × 108 , or 1 × 1010 , cfu/mL for 4 wk . IBS symptoms were monitored daily and scored on to a 6-point Likert scale with the primary outcome variable being abdominal pain or discomfort . A composite symptom score , the subject 's global assessment of IBS symptom relief , and measures of quality of life ( using the IBS-QOL instrument ) were also recorded . RESULTS : B. infantis 35624 at a dose of 1 × 108 cfu was significantly superior to placebo and all other bifidobacterium doses for the primary efficacy variable of abdominal pain as well as the composite score and scores for bloating , bowel dysfunction , incomplete evacuation , straining , and the passage of gas at the end of the 4-wk study . The improvement in global symptom assessment exceeded placebo by more than 20 % ( p < 0.02 ) . Two other doses of probiotic ( 1 × 106 and 1 × 1010 ) were not significantly different from placebo ; of these , the 1 × 1010 dose was associated with significant formulation problems . No significant adverse events were recorded . CONCLUSIONS : B. infantis 35624 is a probiotic that specifically relieves many of the symptoms of IBS . At a dosage level of 1 × 108 cfu , it can be delivered by a capsule making it stable , convenient to administer , and amenable to widespread use . The lack of benefits observed with the other dosage levels of the probiotic highlight the need for clinical data in the final dosage form and dose of probiotic before these products should be used in practice Abstract Background : Symptoms of irritable bowel syndrome ( IBS ) can have a profound impact on emotional health and quality of life , and current treatments are sometimes unsatisfactory for patients facing this lifelong disease . Probiotics , which can normalize gastrointestinal microflora , may alleviate symptoms of IBS . Objective : This preliminary controlled study was conducted to evaluate the effects of the probiotic Bacillus coagulans GBI-30 , 6086 on IBS symptoms . Methods : This was a r and omized , double-blind , parallel-group , placebo-controlled clinical trial involving 44 subjects who received either placebo or B coagulans GBI-30 , 6086 once a day for 8 weeks . Self- assessment s of the severity of IBS symptoms ( abdominal pain and bloating ) were recorded every day for 8 weeks . Because baseline values were significantly different between the 2 study groups , within-group analysis was conducted . Results : Improvements from baseline abdominal pain and bloating scores in the B coagulans GBI-30 , 6086 group were statistically significant for all 7 weekly comparisons ( P < 0.01 ) . In the placebo group , only changes in abdominal pain scores at weeks 6 and 8 achieved statistical significance ( P < 0.05 ) . No treatment-related adverse events or serious adverse events were reported during the 8-week study period . Conclusions : Preliminary data suggest that the patented B coagulans GBI-30 , 6086 probiotic may be a safe and effective option for the relief of abdominal pain and bloating for patients with IBS . Larger , extended trials are needed to verify these results Abstract Objective . Meta-analyses have indicated effect of probiotics on irritable bowel syndrome ( IBS ) . However , few long-term trials have been conducted and uncertainty remains as to effectiveness and long-term effect in a primary care setting . We aim ed to investigate the effect of probiotics compared with placebo in the management of IBS in primary care during a 6-month treatment period and with a 6-month follow-up . Material and methods . We r and omized IBS patients fulfilling Rome III criteria to receive two capsules twice daily either containing placebo or a probiotic mixture of Lactobacillus paracasei ssp paracasei F19 , Lactobacillus acidophilus La5 and Bifidobacterium Bb12 in an amount of 1.3 × 1010 CFU per capsule . Primary endpoint was proportion of responders defined as patients reporting adequate relief ( AR ) at least 50 % of the time in the 6-month treatment period . Secondary outcomes were proportions of patients reporting AR at different time points , and change in gastrointestinal symptoms and health-related quality of life ( HrQOL ) from baseline to 6 and 12 months . Results . A total of 131 patients were included in this study . The proportion of responders in the treatment period was 52 % ( 35/67 ) in the probiotic group versus 41 % ( 26/64 ) in the placebo group , p = 0.18 . Overall we found no difference between the groups in change in gastrointestinal symptoms after treatment . Patients improved in HrQOL , but with no statistically significant difference between the groups . Conclusion . During a 6-month treatment period , we were not able to detect a positive effect of probiotic when compared with placebo 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 Some probiotics have shown efficacy for patients with irritable bowel syndrome ( IBS ) . Lactobacillus ( L. ) plantarum MF1298 was found to have the best in vitro probiotic properties of 22 strains of lactobacilli . The aim of this study was to investigate the symptomatic effect of L. plantarum MF1298 in subjects with IBS . Primary outcome was treatment preference and secondary outcomes were number of weeks with satisfactory relief of symptoms and IBS sum score . Methods The design was a r and omised double blind placebo-controlled crossover trial . 16 subjects with IBS underwent two three-week periods of daily intake of one capsule of 1010 CFU L. plantarum MF 1298 or placebo separated by a four-week washout period . Results Thirteen participants ( 81 % ; 95 % CI 57 % to 93 % ; P = 0.012 ) preferred placebo to L. plantarum MF1298 treatment . The mean ( SD ) number of weeks with satisfactory relief of symptoms in the periods with L. plantarum MF1298 and placebo were 0.50 ( 0.89 ) and 1.44 ( 1.26 ) , respectively ( P = 0.006 ) . IBS sum score was 6.44 ( 1.81 ) in the period with L.
Output:
| Symptom outcomes for dose-specific probiotics were heterogeneous . |
MS213236 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: PURPOSE To evaluate the efficacy and safety of 0.18 % sodium hyaluronate ophthalmic solution ( Rejena , Vismed ) compared with its vehicle for the treatment of signs and symptoms of dry eye disease . DESIGN R and omized , placebo-controlled clinical trial . METHODS A total of 444 subjects with dry eye disease were r and omized 1:1 to active study drug ( n = 221 ) or vehicle control ( n = 223 ) in this multicenter , double-masked trial . Subjects instilled 1 to 2 drops , 3 to 6 times daily for 14 days , with evaluations at Days 7 and 14 . The study 's 2 primary efficacy endpoints were change from baseline at Day 7 in lissamine green staining scores ( objective ) and in global symptom frequency scores ( subjective ) . Results were analyzed using Wilcoxon rank sum test and Student t test in the intent-to-treat ( ITT ) population with last observation carried forward ( LOCF ) . RESULTS At Day 7 , the differences between the active and vehicle groups in change from baseline for lissamine green staining score ( P = .050 , Wilcoxon ; P = .029 , t test ) and global symptom frequency score ( P = .050 , Wilcoxon ; P = .017 , t test ) were both statistically significant . There were no clinical ly relevant safety findings related to the use of Rejena . CONCLUSIONS This study demonstrated the clinical efficacy of Rejena in the treatment of dry eye disease in both a primary objective endpoint and a primary subjective endpoint when compared to its vehicle . The study results also supported the well-known safety profile of Rejena Background Dry eye is a common condition , affecting approximately 10–20 % of the adult population . Artificial tears are often effective in relieving symptoms in mild and moderate dry eye by replenishing deficient tear volume . Sodium hyaluronate has been proposed as a component in artificial tears , due to its viscoelastic rheology . This paper reports on a study carried out to assess the efficacy of two recently developed eyedrops containing 0.1 % and 0.3 % sodium hyaluronate ( SH ) in the treatment of moderate dry eye . Methods Thirteen subjects were recruited with moderate dry eye . Forty microlitres of 0.1 % SH , 0.3 % SH , or 0.9 % saline were instilled in both eyes , and the subjects ’ symptom intensity and non-invasive break-up time ( NIBUT ) were measured at 5 , 15 , 30 , 45 , and 60 min , and then hourly , until 6 h after drop instillation . This was repeated twice following an interval of 7(±1 ) days , but with a different treatment so that at the end of the final visit each subject had trialled all products . Drop allocation was r and omized and double-masked . Results Both symptoms and NIBUT improved with all treatments . These changes were of a larger magnitude and longer duration with the SH containing eyedrops than with saline . SH of 0.3 % tended to perform better than 0.1 % SH and achieved statistical significance ( P=0.04 ) for NIBUT when considered over the whole 6-h study period . Conclusions Sodium hyaluronate of 0.1 % and 0.3 % reduces symptoms of ocular irritation and lengthens NIBUT in subjects with moderate dry eye more effectively than saline , in terms of peak effect and duration of action BACKGROUND / AIMS Hyaluronan ( sodium hyaluronate ) has been shown to confer objective and subjective improvement in patients with dry eye syndrome . This study compared the efficacy and safety of a 0.1 % solution of hyaluronan with 0.9 % saline , when administered topically to the eye , in the treatment of symptoms of severe dry eye syndrome . METHODS A r and omised , double blind , crossover clinical trial in which subjects were r and omised to receive either hyaluronan or saline , applied as one or two drops to the eye , three or four times a day or as required . After 28 days ’ treatment , subjects crossed over to the other study medication for a further 28 days ’ treatment . RESULTS 70 subjects were included in the analyses of efficacy and significant improvements in Schirmer ’s score ( p=0.0006 ) and rose bengal staining score ( p=0.0001 ) were observed during treatment with hyaluronan . In a subjective assessment of the effectiveness of two treatments , a majority of subjects felt that hyaluronan was more effective than saline in alleviating the symptoms of burning and grittiness ( p<0.001 ) . No adverse events attributable to hyaluronan treatment were reported . CONCLUSION The study demonstrates a clear benefit of hyaluronan over saline , in both subjective and objective assessment s of dry eye syndrome . Hyaluronan was shown to be well tolerated Aims To assess the safety and performance of a 0.1 % ( w/v ) solution of sodium hyaluronate ( HA , Fermavisc ® , in the alleviation of symptoms of severe dry eye in comparison with a 1.4 % ( w/v ) solution of polyvinyl alcohol . Methods A r and omised , crossover , multicentre study carried out at eight centres in the UK . Eligible patients giving written informed consent were r and omised to the order in which they would receive the two study products . Each treatment period lasted for 4 weeks , then the patient crossed over to the other study product . Symptoms of burning and grittiness were assessed by visual analogue scale ( VAS ) at each study visit and other objective clinical assessment s of ocular structure and function were carried out at baseline and the end of each treatment period . Results Thirty-nine patients were entered into the study and 32 completed both treatment periods and were included in the statistical analyses . A significant improvement in the patients ’ VAS assessment of burning was seen after treatment with HA ( P = 0.03 , 95 % Confidence Interval : −23.5 to −1.1 ) . This treatment also result ed in a significantly lower rose bengal staining score ( P = 0.04 , 95 % Confidence Interval : −1.62 to −0.05 for the right eye ) . Conclusion The results show a significant clinical benefit in terms of relief of the symptom of burning when HA is applied topically to the eye three or four times per day or as required . HA also appears to have a protective effect on the corneal epithelium , as shown by a reduction in the level of staining of corneal epithelial cells by rose bengal . This study confirms that Fermavisc ® is a safe and effective product for use in the alleviation of symptoms of severe dry eye syndrome Background The ocular surface changes of keratoconjunctivitis sicca ( KCS ) could be the result of the effect of an altered tear film on the epithelial environment . Purpose To evaluate the possibility of improving the environmental conditions of the ocular surface by lowering tear osmolarity , increasing tear film volume and stabilising the tear film . Also , to study the effect of such an improvement on the epithelial cells of the ocular surface . Methods One hundred and thirty-five patients with a diagnosis of KCS were treated on a r and omised basis with either unpreserved hypotonic 0.4 % hyaluronic acid ( HHA ) eye drops or 0.3 % hydroxypropylmethylcellulose plus 0.1 % Dextran 70 ( HPMC ) eye drops 6 times a day for 60 or 90 days . In all patients a Schirmer I test , break-up time ( BUT ) , ocular surface staining with 1 % Bengal Rose , or 2 % fluorescein , as well as subjective symptoms , were recorded before and 15 , 30 and 60 days after the beginning of the study . Patients were divided into three subgroups and the effect of the treatment was studied using three different techniques : the tear ferning test , conjunctival impression cytology and tear osmolarity measurement . Results Improvements in BUT , vital staining , Schirmer I and symptoms were recorded in both groups of treatment , with significant differences for patients treated with 0.4 % HHA . On day 60 , 30 min after installation : tear ferning patterns changed from 100 % pathological ( types III – IV ) to 93 % physiological ( types I – II ) in the 0.4 % HHA group and from 100 % pathological to 78 % physiological in the 0.3 % HPMC group ( p < 0.01 between groups ) . Tear osmolarity shifted from 353 ± 23 to 305 ± 6 mosmolA in the 0 - 4 % HHA group and from 346 ± 15 to 336 ± 8 mosmol/l in the 0.3 % HPMC group ( p < 0.001 between groups ) . On day 90 , the impression cytology score improved from 1.2 to 1.9 in the 0.4 % HHA group while it did not change in the 0.3 % HPMC group ( p < 0.05 between groups ) . Conclusion In KCS appropriate treatment with a hypotonic 0.4 % HHA tear substitute can change the tear environment and results in improvement of the epithelial conditions of the ocular surface This study assessed the repeatability of various methods of measuring tear break-up time ( TBUT ) with and without soft contact lenses ( CLs ) . TBUT was measured on 22 subjects with the tearscope , videokeratoscope and slit-lamp before and after 30 min of soft CL wear , and immediately after CL removal . Slit-lamp corneal TBUT was measured with fluorescein and without fluorescein while wearing CLs . TBUT was measured three times on the right eye only , using each technique in r and omised order . TBUT measurements on CLs were repeated a second day . TBUT measurements were highly variable under all conditions and our results indicated a lack of correlation between techniques . The videokeratoscope was the least repeatable ; while the tearscope was the most repeatable technique Between mid-May and mid-July 1987 we performed a prospect i ve crossover study of two unit-dose preservative-free artificial tear solutions , 1.4 % polyvinyl alcohol ( Refresh ) and 0.1 % sodium hyaluronate ( Hylorin ) in 14 female patients with severe dry eye syndrome . The patients were examined before treatment and after each of two trials with both products . A significant reduction in the mean score for dry-eye-induced keratitis ( p = 0.001 ) and for mucous str and s ( p = 0.03 ) was observed following the second of two trials with sodium hyaluronate . A significant reduction in the mean score for burning and irritation was observed with both solutions ( p = 0.009 ) . We believe that the elimination of preservatives from artificial tear preparations may substantially reduce the iatrogenic effects of these frequently applied medications Clinical trials to evaluate the effectiveness of therapy for dry eye disease are challenging because of the nature of the disease , the multiple palliative methods used by patients to control their symptoms , and the potential limitations of the techniques available to evaluate therapeutic outcomes . This review identifies some of the pitfalls encountered in recent clinical trials in dry eye disease . The peculiarities of dry eye disease with respect to symptoms , signs , and patho- physiological changes are discussed . Potential problems that apply to all clinical trials , including patient selection , r and omization in small population s , and assessment of the placebo effect , are presented with respect to dry eye clinical trials . Considerations regarding study design address inclusion /exclusion criteria and selection of outcome measures . Special attention is given to methods of symptom analysis , techniques of staining of the ocular surface , and grading systems for surface staining . Alternative methods to the st and ard clinical trial are mentioned to place them in perspective for overall evaluation of dry eye disease therapy . Finally , caveats are provided to encourage investigators to vigorously conduct future clinical trials in dry eye therapy Purpose : To compare the effects of Viscofresh 0.5 % ( carmellose sodium 0 . 5 % ) versus Lubristil ( sodium hyaluronate 0.15 % ) in dry eye syndrome and to study the influence of these two treatments on the expression of various inflammatory markers by flow cytometry in impression cytology specimens . Methods : In this r and omized , masked-observer , parallel group , single-center study , 15 patients with dry eye syndrome were r and omized to sodium carmellose 0.5 % or sodium hyaluronate 0.15 % 1-month treatment after a 1-week washout period . Corneal staining with flurescein , breakup time , Schirmer 1 test with anesthesia ( Jones test ) , and tear clearance were assessed . Besides , conjunctival impression cytology was performed to investigate inflammatory markers ( CD3 , CD11b , and HLA-DR ) using flow cytometry . Results : Carmellose group shows statistical improvement compared with the hyaluronate group in breakup time , corneal staining , and HLA-DR . The two other inflammatory markers had also a tendency for a decreased expression in both groups , with no statistical significance . There were neither visual acuity loss nor other complications related to treatment . Conclusion : Both artificial tears improve dry eye signs and symptoms and inflammatory markers expression , with significant better results in carmellose group Background / aims : Several studies have reported that sodium hyaluronate is able to improve both symptoms and signs in patients with dry eye but none have demonstrated an improvement of conjunctival epithelial cell abnormalities of the ocular surface . The aim of this study was to explore the effect of sodium hyaluronate-containing eye drops on the ocular surface of patients with dry eye during long term treatment . Methods : A r and omised double blind study was undertaken in 86 patients with medium to severe dry eye ( that is , rose beng
Output:
| In summary , neither preparation was shown to be consistently superior across all outcome measures .
The difference in effect between preparations on SH and TBUT was not clinical ly significant |
MS213237 | ***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: Despite improvements in st and ard therapy with rituximab , cyclophosphamide , doxorubicin , vincristine and prednisone for patients with untreated , diffuse large B-cell lymphoma , up to 40 % of these patients relapse . Lenalidomide alone or in combination with rituximab has been shown to be active in relapsed/refractory aggressive lymphomas . In this phase I study we determined the maximum tolerated dose of lenalidomide plus rituximab , cyclophosphamide , doxorubicin , vincristine and prednisone in untreated , elderly ( median age 68 years ) patients with diffuse large B-cell lymphoma . Four lenalidomide doses ( 5 , 10 , 15 , and 20 mg/day on days 1–14 ) allocated using the continual re assessment method were planned to be administered for 14 days in combination with each course of rituximab , cyclophosphamide , doxorubicin , vincristine and prednisone for a total of six courses . Seven cohorts of patients ( n=3 in each cohort ) were treated ( total n=21 ) at 10 , 20 , 15 , 15 , 15 , 10 , and 10 mg of lenalidomide . Dose-limiting toxicities occurred in seven patients during the first three courses of treatment . The third dose-level of lenalidomide ( 15 mg/day ) was selected as the maximum tolerated dose , with an estimated probability of dose-limiting toxicities of 0.345 ( 95 % credibility interval 0.164–0.553 ) . Grade 3–4 hematologic adverse events were : neutropenia in 28 % of the courses , thrombocytopenia in 9 % , and anemia in 3 % . Non-hematologic toxicities were moderate : grade 4 increase of creatinine phosphokinase ( n=1 ) , grade 3 cardiac ( n=2 ) , grade 3 neurological ( n=3 ) , and grade 3 gastrointestinal ( n=1 ) . In this phase I study , the overall response rate was 90 % , with 81 % achieving complete remission . This combination regimen appears safe in elderly patients with diffuse large B-cell lymphoma and its efficacy will be assessed in the ongoing phase II trial . This trial was registered at www . clinical trials.gov as NCT00907348 BACKGROUND Cyclophosphamide , doxorubicin , vincristine , and prednisolone ( CHOP ) is used to treat patients with non-Hodgkin lymphoma . Interval decrease from 3 weeks of treatment ( CHOP-21 ) to 2 weeks ( CHOP-14 ) , and addition of rituximab to CHOP-21 ( R-CHOP-21 ) has been shown to improve outcome in elderly patients with diffuse large B-cell lymphoma ( DLBCL ) . This r and omised trial assessed whether six or eight cycles of R-CHOP-14 can improve outcome of these patients compared with six or eight cycles of CHOP-14 . METHODS 1222 elderly patients ( aged 61 - 80 years ) were r and omly assigned to six or eight cycles of CHOP-14 with or without rituximab . Radiotherapy was planned to sites of initial bulky disease with or without extranodal involvement . The primary endpoint was event-free survival ; secondary endpoints were response , progression during treatment , progression-free survival , overall survival , and frequency of toxic effects . Analyses were done by intention to treat . The trial is registered on National Cancer Institute website , number NCT00052936 and as EU-20243 . FINDINGS 3-year event-free survival was 47.2 % after six cycles of CHOP-14 ( 95 % CI 41.2 - 53.3 ) , 53.0 % ( 47.0 - 59.1 ) after eight cycles of CHOP-14 , 66.5 % ( 60.9 - 72.0 ) after six cycles of R-CHOP-14 , and 63.1 % ( 57.4 - 68.8 ) after eight cycles of R-CHOP-14 . Compared with six cycles of CHOP-14 , the improvement in 3-year event-free survival was 5.8 % ( -2.8 - 14.4 ) for eight cycles of CHOP-14 , 19.3 % ( 11.1 - 27.5 ) for six cycles of R-CHOP-14 , and 15.9 % ( 7.6 - 24.2 ) for eight cycles of R-CHOP-14 . 3-year overall survival was 67.7 % ( 62.0 - 73.5 ) for six cycles of CHOP-14 , 66.0 % ( 60.1 - 71.9 ) for eight cycles of CHOP-14 , 78.1 % ( 73.2 - 83.0 ) for six cycles of R-CHOP-14 , and 72.5 % ( 67.1 - 77.9 ) for eight cycles of R-CHOP-14 . Compared with treatment with six cycles of CHOP-14 , overall survival improved by -1.7 % ( -10.0 - 6.6 ) after eight cycles of CHOP-14 , 10.4 % ( 2.8 - 18.0 ) after six cycles of R-CHOP-14 , and 4.8 % ( -3.1 - 12.7 ) after eight cycles of R-CHOP-14 . In a multivariate analysis that used six cycles of CHOP-14 without rituximab as the reference , and adjusting for known prognostic factors , all three intensified regimens improved 3-year event-free survival ( eight cycles of CHOP-14 : RR [ relative risk ] 0.76 [ 0.60 - 0.95 ] , p=0.0172 ; six cycles of R-CHOP-14 : RR 0.51 [ 0.40 - 0.65 ] , p<0.0001 ; eight cycles of R-CHOP-14 : RR 0.54 [ 0.43 - 0.69 ] , p<0.0001 ) . Progression-free survival improved after six cycles of R-CHOP-14 ( RR 0.50 [ 0.38 - 0.67 ] , p<0.0001 ) , and eight cycles of R-CHOP-14 ( RR 0.59 [ 0.45 - 0.77 ] , p=0.0001 ) . Overall survival improved only after six cycles of R-CHOP-14 ( RR 0.63 [ 0.46 - 0.85 ] , p=0.0031 ) . In patients with a partial response after four cycles of chemotherapy , eight cycles were not better than six cycles . INTERPRETATION Six cycles of R-CHOP-14 significantly improved event-free , progression-free , and overall survival over six cycles of CHOP-14 treatment . Response-adapted addition of chemotherapy beyond six cycles , though widely practice d , is not justified . Of the four regimens assessed in this study , six cycles of R-CHOP-14 is the preferred treatment for elderly patients , with which other approaches should be compared Lenalidomide – rituximab therapy is effective in grade 1–2 follicular and mantle cell lymphoma , but its efficacy in diffuse large B-cell lymphoma ( DLBCL ) , transformed large cell lymphoma ( TL ) and grade 3 follicular lymphoma ( FLG3 ) is unknown . In this phase II trial , 45 patients with relapsed or refractory DLBCL ( n=32 ) , TL ( n=9 ) or FLG3 ( n=4 ) who had received 1–4 prior lines of treatment were given 20 mg oral lenalidomide on days 1–21 of each 28-day cycle , and intravenous rituximab ( 375 mg/m2 ) weekly during cycle 1 . Grade 3/4 hematological toxicities included neutropenia ( 53 % ) , lymphopenia ( 40 % ) , thrombocytopenia ( 33 % ) , leukopenia ( 27 % ) and anemia ( 18 % ) , with a median follow-up time of 29.1 months ( range 14.7–52.0 months ) . Overall response ( OR ) rate was 33 % ; median response duration was 10.2 months . Median progression-free survival ( PFS ) and overall survival ( OS ) were 3.7 and 10.7 months , respectively . Nine of the 15 responding patients ( three partial response ( PR ) , six complete response ( CR ) ) proceeded with stem cell transplantation ( SCT ) and were censored at the time of transplantation . When data were analyzed without censoring , median PFS remained 3.7 months and response duration increased to 30.9 months . Rituximab plus oral lenalidomide is well tolerated and effective for patients with relapsed/refractory DLBCL and TL . SCT after lenalidomide – rituximab is associated with prolonged response duration Relapsed/refractory diffuse large B‐cell lymphoma ( DLBCL ) is associated with a poor prognosis . Outcomes are particularly poor following immunochemotherapy failure or relapse within 12 months of induction . We conducted a Phase I/II trial of lenalidomide plus RICE ( rituximab , ifosfamide , carboplatin , and etoposide ) ( RICER ) as a salvage regimen for first‐relapse or primary refractory DLBCL . Dose‐escalated lenalidomide was combined with RICE every 14 d. After three cycles of RICER , patients with chemosensitive disease underwent stem cell collection and consolidation with BEAM [ BCNU ( carmustine ) , etoposide , cytarabine , melphalan ] followed by autologous stem cell transplantation ( autoSCT ) . Patients who recovered from autoSCT toxicities within 90 d initiated maintenance treatment with lenalidomide 25 mg daily for 21 d every 28 d for 12 months . No dose‐limiting or unexpected toxicities occurred with lenalidomide 25 mg plus RICE . Grade 3/4 haematological toxicities resolved appropriately , and planned dose density and dose intensity of RICER were preserved . No lenalidomide or RICE dose reductions were required in any of the three cycles . After two cycles of RICER , nine of 15 patients ( 60 % ) achieved a complete response , and two achieved a partial response ( 13 % ) . Combining lenalidomide with RICE is feasible , and results in promising response rates ( particularly complete response rates ) in high‐risk DLBCL patients BACKGROUND Lenalidomide is an immunomodulatory agent with antitumor activity in B-cell malignancies . This phase II trial aim ed to demonstrate the safety and efficacy of lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma ( DLBCL ) , mantle cell lymphoma ( MCL ) , follicular grade 3 lymphoma ( FL-III ) , or transformed lymphoma ( TL ) . METHODS Patients received oral lenalidomide 25 mg on days 1 - 21 every 28 days as tolerated or until progression . The primary end point was overall response rate ( ORR ) . RESULTS Two hundred and seventeen patients enrolled and received lenalidomide . The ORR was 35 % ( 77/217 ) , with 13 % ( 29/217 ) complete remission ( CR ) , 22 % ( 48/217 ) partial remission , and 21 % ( 45/217 ) with stable disease . The ORR for DLBCL was 28 % ( 30/108 ) , 42 % ( 24/57 ) for MCL , 42 % ( 8/19 ) for FL-III , and 45 % ( 15/33 ) for TL . Median progression-free survival for all 217 patients was 3.7 months [ 95 % confidence interval ( CI ) 2.7 - 5.1 ] . For 77 responders , the median response duration lasted 10.6 months ( 95 % CI 7.0-NR ) . Median response duration was not reached in 29 patients who achieved a CR and in responding patients with FL-III or MCL . The most common adverse event was myelosuppression with grade 4 neutropenia and thrombocytopenia in 17 % and 6 % , respectively . CONCLUSION Lenalidomide is well tolerated and produces durable responses in patients with relapsed or refractory aggressive non-Hodgkin 's lymphoma BACKGROUND Up to 40 % of elderly patients with untreated diffuse large B-cell lymphoma ( DLBCL ) given a regimen of rituximab , cyclophosphamide , doxorubicin , vincristine , and prednisolone every 21 days ( R-CHOP21 ) relapse or develop refractory disease . Lenalidomide has high activity in relapsed or refractory aggressive B-cell lymphomas . In phase 2 of the REAL07 trial , we aim ed to establish the safety and efficacy of the combination of lenalidomide and R-CHOP21 in elderly patients with untreated DLBCL .
Output:
| More importantly , after lenalidomide treatment , the patients with non-GCB DLBCL did not show significantly worse progression-free survival ( PFS ) and overall survival ( OS ) compared with GCB subtype .
Lenalidomide as treatments for DLBCL patients , non-GCB DLBCL patients did not show significantly worse prognosis compared with GCB DLBCL |
MS213238 | ***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: Study Design . A prospect i ve , r and omized , single ( investigator ) blind , comparative efficacy trial was conducted . Objective . To compare the efficacy of continuous low-level heat wrap therapy ( 40 C , 8 hours/day ) with that of ibuprofen ( 1200 mg/day ) and acetaminophen ( 4000 mg/day ) in subjects with acute nonspecific low back pain . Summary of Background Data . The efficacy of topical heat methods , as compared with oral analgesic treatment of low back pain , has not been established . Methods . Subjects ( n = 371 ) were r and omly assigned to heat wrap ( n = 113 ) , acetaminophen ( n = 113 ) , or ibuprofen ( n = 106 ) for efficacy evaluation , or to oral placebo ( n = 20 ) or unheated back wrap ( n = 19 ) for blinding . Outcome measures included pain relief , muscle stiffness , lateral trunk flexibility , and disability . Efficacy was measured over two treatment days and two follow-up days . Results . Day 1 pain relief for the heat wrap ( mean , 2 ) was higher than for ibuprofen ( mean , 1.51;P = 0.0007 ) or acetaminophen ( mean , 1.32;P = 0.0001 ) . Extended mean pain relief ( Days 3 to 4 ) for the heat wrap ( mean , 2.61 ) also was higher than for ibuprofen ( mean , 1.68;P = 0.0001 ) or acetaminophen ( mean , 1.95;P = 0.0009 ) . Lateral trunk flexibility was improved with the heat wrap ( mean change , 4.28 cm ) during treatment ( P ≤ 0.009 vs acetaminophen [ mean change , 2.93 cm ] , P ≤ 0.001 vs ibuprofen [ mean change , 2.51 cm ] ) . The results were similar on Day 4 . Day 1 reduction in muscle stiffness with the heat wrap ( mean , 16.3 ) was greater than with acetaminophen ( mean , 10.5;P = 0.001 ) . Disability was reduced with the heat wrap ( mean , 4.9 ) , as compared with ibuprofen ( mean , 2.7;P = 0.01 ) and acetaminophen ( mean , 2.9;P = 0.0007 ) , on Day 4 . None of the adverse events were serious . The highest rate ( 10.4 % ) was reported in the ibuprofen group . Conclusion . Continuous low-level heat wrap therapy was superior to both acetaminophen and ibuprofen for treating low back pain A double-blind , 18-center , balanced trial of diflunisal vs. cyclobenzaprine HCl vs. these two drugs combined vs. placebo produced complete results from 175 patients . They had sought treatment at the cooperating centers for acute painful spasms of the back within a day or two of trauma or strain . Global results over the 7 to 10 days of observations revealed a clinical ly and statistically significant superiority of the combined therapy by Day 4 ( P=0.006 ) and almost all patients recovered within a week to 10 days . A combination therapy with an effective safe analgesic and a true muscle relaxant for less than a week appears to be an excellent relief measure for acute back problems The study objective was to assess the efficacy and patient acceptance of ketorolac as an alternative to meperidine for the treatment of severe musculoskeletal low back pain ( LBP ) . A double blinded prospect i ve trial in a convenience sample of patients > 18 years of age presenting to an urban university hospital emergency department ( ED ) was conducted over a 19-month period . Patients were included if the pain was musculoskeletal in origin and was severe enough to warrant parenteral analgesics . Patients were r and omized to receive 1 mg/kg meperidine intramuscularly ( IM ) or 60 mg ketorolac IM . Pain intensity was measured preadministration and at 60 minutes via a 100 mm Visual Analog Scale ( VAS ) . Outcomes measured at 60 minutes were pain intensity decrease ( PID ) , patient satisfaction , rescue analgesia requirement , sedation level , and adverse effects . Clinical ly significant pain reduction was defined as a PID of at least 13 mm or a reduction in pain of least 30 % . One hundred fifty-five patients were enrolled ( meperidine = 75 , ketorolac = 80 ) and 153 patients completed the study . At 60 minutes the mean PID was 7 mm less in the ketorolac group ( 95 % confidence interval [ CI ] - 15 mm to 2.6 mm ) . Pain reduction of at least 30 % occurred in 63 % of the ketorolac group versus 67 % of the meperidine group ( 95 % CI , odds ratio [ OR ] .43 to 1.61 ) . Rescue analgesia was required in 35 % of the ketorolac group versus 37 % of the meperidine group ( 95 % CI , OR .47 to 1.74 ) . Patient satisfaction was less in the ketorolac group ( ketorolac 68 % satisfied versus meperidine 74 % satisfied ) however this was not significant ( 95 % CI , OR .66 to 2.72 ) . Sedation level and adverse effects were significantly greater in the meperidine group . Ketorolac shows comparable single dose analgesic efficacy to a single moderate dose of meperidine with less sedation and adverse effects in an ED population with severe musculoskeletal LBP . The trend for greater pain reduction and patient satisfaction with meperidine needs further investigation This study reports on 105 patients with acute low-back pain given tizanidine ( 4 mg three times daily ) plus ibuprofen ( 400 mg three times daily ) or placebo plus ibuprofen ( 400 mg three times daily ) . Patients assessed their pain using visual analogue scales in a daily diary and the doctor assessed their condition at baseline and on days 3 and 7 . Both groups were treated effectively , but earlier improvement occurred in patients given tizanidine/ibuprofen , particularly regarding pain at night and at rest . Doctors assessed the helpfulness of treatment : tizanidine/ibuprofen was significantly better than placebo/ibuprofen at day 3 ( P = 0.05 ) . Significant differences between treatments in favour of tizanidine/ibuprofen occurred in patients with moderate and severe pain at night ( P<0.05 ) , at rest ( P<0.05 ) and those with moderate or severe sciatica ( P<0.05 ) . Significantly more patients given placebo/ibuprofen had gastro-intestinal side-effects compared with tizanidine/ibuprofen ( P = 0.002 ) . This supports previous work in animals showing that tizanidine mediates gastric mucosal protection against anti-inflammatory drugs . More patients given tizanidine/ibuprofen suffered drowsiness and other central nervous system effects ( P = 0.025 ) . In patients with severe acute low-back pain , however , some sedation and bed rest is advantageous . This study shows that tizanidine/ibuprofen is more effective in the treatment of moderate or severe acute low-back pain than placebo and ibuprofen alone Two hundred and sixty patients with lumbago or sciatic pain participated in a multicenter observer-blind r and omized trial to compare the efficacy and tolerability of dipyrone 2.5 g , diclofenac 75 mg , and placebo administered as an intramuscular injection once daily for the duration of one to two days . The effectiveness of the test treatments in relieving sciatic pain was measured by a visual analog scale ( VAS ) before and 30 minutes , 1 , 2 , 3 , 6 and 24 hours after each injection . In addition , the patient 's general well-being was measured on a 5-point rating scale on day 0 , 1 and 2 . At the end of the trial , the patients evaluated the overall efficacy of the study drugs on a 5-point rating scale . Minimal finger-toe distance was measured every day of the trial . Pain intensity on VAS ( primary endpoint ) showed a significantly greater reduction with dipyrone than with diclofenac or placebo between 1 and 6 hours after application ( p < 0.01 ) and at the end of the trial ( after 48 hours ) . Improvement in general well-being and minimal finger-toe distance was greatest in the dipyrone group . 59 % of the patients with dipyrone assessed the overall efficacy as " excellent " or " very good " , compared with 30 % with diclofenac , and 18 % with placebo . Adverse reactions were reported in only 7 patients ( 3 % ) , 4 ( 5 % ) in the dipyrone , 1 ( 1 % ) in the diclofenac , and 2 ( 2 % ) in the placebo group A double-blind trial of azapropazone ( 300 mg . 4-times daily ) and ketoprofen ( 50 mg . 4-times daily ) was carried out in 50 patients with acute backache sufficiently severe to necessitate hospital admission . Of 39 patients who completed the full 3-weeks ' study period , 18 preferred azapropazone therapy , 10 preferred ketoprofen , and 11 showed either preference for the intermediate placebo period or no preference at all . Ten patients suffered from sufficiently severe side-effects with ketoprofen to necessitate their withdrawal from the trial . There were no similar episodes of withdrawal occurring during the azapropazone period The roles of bedrest , antiinflammatory medication , and analgesic medication in the treatment of acute back strain were objective ly analyzed to determine whether they have a measurable effect on the return of patients to full daily activities as well as on the relief of pain . Two hundred patients were studied prospect ively . Each patient had the diagnosis of acute back strain , which was defined as nonradiating low-back pain . The results of the patient 's neurologic examination , straight leg raising test , and lumbosacral spine roentgenograms had to be within normal limits for the patient to be included in the study . The results showed that bedrest , as compared with ambulation , will decrease the amount of time lost from work by 50 % . Bedrest will also decrease the amount of discomfort by 60 % . Analgesic medication , when combined with bedrest , will further decrease the amount of pain incurred , particularly when used in the first three days of the healing process . However , analgesic medication will not allow a more prompt return to work . Antiinflammatory medication , when added to bedrest in the treatment of lumbago , does not provide an advantage over bedrest alone BACKGROUND Acute low back pain is one of the most frequent complaints presented in general practice . This study compares acupuncture and antiphlogistica in the treatment of acute low back pain in general practice . MATERIAL AND METHODS Among 60 consecutively included patients with acute low back pain , 30 patients were r and omized to st and ardised acupuncture treatment for two weeks , and 30 patients to entero-soluble naproxen 500 mg twice daily for ten days . Effects were observed over six months , and observed for a further 12 months with regard to relapse of low back pain and number of days on sickness leave . RESULTS There were no differences in pain or stiffness ( VAS , physical tests ) at inclusion , nor in the reduction of pain or stiffness over a six month evaluation . However , patients receiving acupuncture used significantly less analgetic drugs during the first week after start of treatment than those receiving naproxen ( 2/28 versus 11/29 , p < 0.01 ) . Patients receiving acupuncture also reported fewer new episodes of low back pain ( 11/28 versus 30/29 , p < 0.05 ) during the 6 + 12 month follow-up . Side effects were frequent in the naproxen group , especially gastro-enteric side effects ( 0/28 versus 15/29 , p < 0.01 ) . INTERPRETATION St and ardised acupuncture treatment seems to be safe and effective in the treatment of acute low back pain in general practice Thirty-seven patients with chronic back pain were entered into a r and omised , 3-way , double-blind , cross-over comparison of naproxen sodium 550 mg twice daily , diflunisal 500 mg twice daily , and placebo . Each treatment was given for 14 days after a preadmission wash-out week during which only paracetamol was allowed . Patients were assessed on admission and at the end of each treatment with respect to global pain , night pain , pain on movement , and pain on st and ing . Both visual analogue scales and simple descriptive scales were used to measure pain . Side effects were elicited by a nonleading question . Both methods of pain measurement gave similar results and were highly correlated . Naproxen sodium was superior to placebo in relieving global pain and depending on the method of measurement , in relieving night pain and pain on movement . Diflunisal showed no significant differences from placebo . Side effects were similar on all 3 treatments . The final preference of the patients was significantly in favour of the active treatments Pain syndromes of the lumbar spine are one of the main problems in orthopedic practice . The therapeutic effect of NSAIDs is not subject to doubt in this connection . But considering that the application of NSAIDs is frequently associated with side effects , a reduction of dosage would be to the patient 's benefit . Clinical studies have shown that concomitant treatment with vitamins B1 , B6 , B12 and diclofenac leads to a more efficient pain
Output:
| The results of the qualitative analysis showed that there is conflicting evidence ( level 3 ) that NSAIDs are more effective than paracetamol for acute low back pain , and that there is moderate evidence ( level 2 ) that NSAIDs are not more effective than other drugs for acute low back pain .
There is strong evidence ( level 1 ) that various types of NSAIDs are equally effective for acute low back pain .
REVIEW ER 'S CONCLUSIONS In conclusion , the evidence from the 51 trials included in this review suggests that NSAIDs are effective for short-term symptomatic relief in patients with acute low back pain .
Furthermore , there does not seem to be a specific type of NSAID which is clearly more effective than others . |
MS213239 | ***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 whether sunitinib plus docetaxel improves clinical outcomes for patients with human epidermal growth factor receptor 2 (HER2)/neu-negative advanced breast cancer ( ABC ) versus docetaxel alone . PATIENTS AND METHODS In this phase III study , patients were r and omly assigned to open-label combination therapy ( sunitinib 37.5 mg/d , days 2 to 15 every 3 weeks ; and docetaxel 75 mg/m(2 ) , day 1 every 3 weeks ) or monotherapy ( docetaxel 100 mg/m(2 ) every 3 weeks ) . Progression-free survival ( PFS ) was the primary end point . RESULTS Two hundred ninety-six patients were r and omly assigned to combination therapy , and 297 patients were assigned to monotherapy . Median PFS times were 8.6 and 8.3 months with combination therapy and monotherapy , respectively ( hazard ratio , 0.92 ; one-sided P = .265 ) . The objective response rate ( ORR ) was significantly higher with the combination ( 55 % ) than with monotherapy ( 42 % ; one-sided P = .001 ) . Duration of response was similar in both arms ( 7.5 months with the combination v 7.2 months with monotherapy ) . Median overall survival ( OS ) times were 24.8 and 25.5 months with combination therapy and monotherapy , respectively ( one-sided P = .904 ) . There were 107 deaths with the combination and 91 deaths with monotherapy . The frequency of common adverse events ( AEs ) was higher with the combination , as were treatment discontinuations caused by AEs . CONCLUSION The combination of sunitinib plus docetaxel improved ORR but did not prolong either PFS or OS compared with docetaxel alone when given to an unselected HER2/neu-negative cohort as first-line treatment for ABC . Sunitinib combination therapy may also have result ed in AEs that yield an unfavorable risk-benefit ratio . The sunitinib-docetaxel regimen evaluated in this study is not recommended for further use in ABC BACKGROUND In a phase III trial , 3-weekly capecitabine ( 1250 mg/m(2 ) twice daily days 1 - 14 ) plus docetaxel ( 75 mg/m(2 ) day 1 ) demonstrated significantly superior overall survival to 3-weekly docetaxel ( 100 mg/m(2 ) day 1 ) . We report a retrospective analysis of the impact of capecitabine/docetaxel dose reduction on safety and efficacy . PATIENTS AND METHODS Safety and efficacy data were analyzed retrospectively according to the actual doses of capecitabine and docetaxel administered . RESULTS More patients receiving capecitabine/docetaxel ( 65 % ) had dose reductions for adverse events than docetaxel alone ( 35 % ) . In most patients requiring dose reduction with the combination ( 80 % ) , capecitabine and docetaxel were simultaneously reduced to 950 mg/m(2 ) and 55 mg/m(2 ) , respectively . Subsequently , there were fewer cycles ( 17 % ) with grade 3/4 adverse events than with the full doses ( 34 % ) . Time to progression and overall survival appeared to be similar in patients starting the second cycle with reduced doses of capecitabine/docetaxel and those who continued to receive full doses of capecitabine/docetaxel for at least the first four cycles . CONCLUSIONS Capecitabine/docetaxel dosing flexibility allows management of side-effects without compromising efficacy . This retrospective analysis , as well as multiple phase II studies of taxanes with reduced-dose capecitabine , shows that reducing the starting dose of capecitabine with docetaxel is a reasonable strategy for the treatment of patients with metastatic breast cancer . In addition , reducing the dose of both agents may be appropriate BACKGROUND The purpose of this study was to compare docetaxel plus epirubicin versus docetaxel plus capecitabine combinations as front-line treatment in women with advanced breast cancer ( ABC ) . PATIENTS AND METHODS Previously untreated patients with ABC were r and omly assigned to receive docetaxel 75 mg/m(2 ) plus epirubicin 75 mg/m(2 ) ( DE ) on day 1 or docetaxel 75 mg/m(2 ) on day 1 plus capecitabine 950 mg/m(2 ) orally twice daily on days 1 - 14 ( DC ) in 21-day cycles . Previous anthracycline-based (neo)-adjuvant chemotherapy was allowed if completed > 1 year before enrollment . The primary objective of the study was to compare time to disease progression ( TTP ) . RESULTS One hundred and thirty-six women were treated on each arm and median TTP was 10.6 versus 11.0 months ( P = 0.7 ) , for DE and DC , respectively . According to RECIST criteria we observed 15 ( 11 % ) versus 11 ( 8 % ) complete responses and 55 ( 40 % ) versus 61 ( 45 % ) partial responses ( P = 0.8 ) , with DE and DC , respectively . Severe toxicity included grade 3 - 4 neutropenia ( 57 % versus 46 % ; P = 0.07 ) , febrile neutropenia ( 11 % versus 8 % ; P = 0.4 ) , h and -foot syndrome ( 0 % versus 4 % ; P = 0.02 ) , grade 2 - 3 anemia ( 20 % versus 7 % ; P = 0.001 ) and asthenia ( 12 % versus 6 % ; P = 0.09 ) with DE and DC , respectively . CONCLUSIONS The DE and DC regimens have similar efficacy but different toxicity . Either regimen can be used as front-line treatment of ABC PURPOSE Dexrazoxane was found effective in reducing doxorubicin cardiotoxicity when given at a dose ratio ( dexrazoxane : doxorubicin ) of 20:1 . Pre clinical studies indicated that dexrazoxane at a dose ratio of 10 to 15:1 also protected against epirubicin-induced cardiotoxicity . The main objective of this study was to investigate the efficacy of dexrazoxane , given at a dose ratio of 10:1 against epirubicin cardiotoxicity . PATIENTS AND METHODS One hundred sixty-two advanced breast cancer patients were r and omized to receive epirubicin-based chemotherapy with or without dexrazoxane . Patients who had previously received adjuvant chemotherapy that contained anthracyclines were treated with cyclophosphamide 600 mg/m2 intravenously ( IV ) , epirubicin 60 mg/m2 IV , and fluorouracil 600 mg/m2 IV , on day 1 every 3 weeks . The other patients were treated with epirubicin 120 mg/m2 IV on day 1 every 3 weeks . Cardiac toxicity was defined as clinical signs of congestive heart failure , a decrease in resting left ventricular ejection fraction ( LVEF ) to < or = 45 % , or a decrease from baseline resting LVEF of > or = 20 EF units . RESULTS One hundred sixty patients were evaluated . Cardiotoxicity was recorded in 18 of 78 patients ( 23.1 % ) in the control arm and in six of 82 ( 7.3 % ) in the dexrazoxone arm . The cumulative probability of developing cardiotoxicity was significantly lower in dexrazoxane-treated patients than in control patients ( P = .006 ; odds ratio , 0.29 ; 95 % confidence limit [ CL ] , 0.09 to 0.78 ) . Noncardiac toxicity , objective response , progression-free survival , and overall survival were similar in both arms . CONCLUSION Dexrazoxane given at a dexrazoxane : epirubicin dose ratio of 10:1 protects against epirubicin-induced cardiotoxicity and does not affect the clinical activity and the noncardiac toxicity of epirubicin . The clinical use of dexrazoxane should be recommended in patients whose risk of developing cardiotoxicity could hamper the eventual use and possible benefit of epirubicin Our objective was to determine whether oral etoposide and cisplatin combination ( EoP ) is superior to paclitaxel in the treatment of advanced breast cancer ( ABC ) patients pretreated with anthracyclines . From December 1997 to August 2003 , 201 patients were r and omised , 100 to EoP and 101 to paclitaxel arms . Four patients in each arm were ineligible . The doses of etoposide and cisplatin were 50 mg p.o . twice a day for 7 days and 70 mg m−2 intravenously ( i.v . ) on day 1 , respectively , and it was 175 mg m−2 on day 1 for paclitaxel . Both treatments were repeated every 3 weeks . A median of four cycles of study treatment was given in both arms . The response rate obtained in the EoP arm was significantly higher ( 36.3 vs 22.2 % ; P=0.038 ) . Median response duration was longer for the EoP arm ( 7 vs 4 months ) ( P=0.132 ) . Also , time to progression was significantly in favour of the EoP arm ( 5.5 vs 3.9 months ; P=0.003 ) . Median overall survival was again significantly longer in the EoP arm ( 14 vs 9.5 months ; P=0.039 ) . Toxicity profile of both groups was similar . Two patients in each arm were lost due to febrile neutropenia . The observed activity and acceptable toxicity of EoP endorses the employment of this combination in the treatment of ABC following anthracyclines PURPOSE An American Society of Clinical Oncology ( ASCO ) provisional clinical opinion ( PCO ) offers timely clinical direction to ASCO 's membership following publication or presentation of potentially practice -changing data from major studies . This PCO addresses the integration of palliative care services into st and ard oncology practice at the time a person is diagnosed with metastatic or advanced cancer . CLINICAL CONTEXT Palliative care is frequently misconstrued as synonymous with end-of-life care . Palliative care is focused on the relief of suffering , in all of its dimensions , throughout the course of a patient 's illness . Although the use of hospice and other palliative care services at the end of life has increased , many patients are enrolled in hospice less than 3 weeks before their death , which limits the benefit they may gain from these services . By potentially improving quality of life ( QOL ) , cost of care , and even survival in patients with metastatic cancer , palliative care has increasing relevance for the care of patients with cancer . Until recently , data from r and omized controlled trials ( RCTs ) demonstrating the benefits of palliative care in patients with metastatic cancer who are also receiving st and ard oncology care have not been available . RECENT DATA Seven published RCTs form the basis of this PCO . PROVISIONAL CLINICAL OPINION Based on strong evidence from a phase III RCT , patients with metastatic non-small-cell lung cancer should be offered concurrent palliative care and st and ard oncologic care at initial diagnosis . While a survival benefit from early involvement of palliative care has not yet been demonstrated in other oncology setting s , substantial evidence demonstrates that palliative care-when combined with st and ard cancer care or as the main focus of care-leads to better patient and caregiver outcomes . These include improvement in symptoms , QOL , and patient satisfaction , with reduced caregiver burden . Earlier involvement of palliative care also leads to more appropriate referral to and use of hospice , and reduced use of futile intensive care . While evidence clarifying optimal delivery of palliative care to improve patient outcomes is evolving , no trials to date have demonstrated harm to patients and caregivers , or excessive costs , from early involvement of palliative care . Therefore , it is the Panel 's expert consensus that combined st and ard oncology care and palliative care should be considered early in the course of illness for any patient with metastatic cancer and /or high symptom burden . Strategies to optimize concurrent palliative care and st and ard oncology care , with evaluation of its impact on important patient and caregiver outcomes ( eg , QOL , survival , health care services utilization , and costs ) and on society , should be an area of intense research . NOTE ASCO 's provisional clinical opinions ( PCOs ) reflect expert consensus based on clinical evidence and literature available at the time they are written and are intended to assist physicians in clinical decision making and identify questions and setting s for further research . Because of the rapid flow of scientific information in oncology , new evidence may have emerged since the time a PCO was su bmi tted for publication . PCOs are not continually up date d and may not reflect the most recent evidence . PCOs can not account for individual variation among patients and can not be considered inclusive of all proper methods of care or exclusive of other treatments . It is the responsibility of the treating physician or other health care provider , relying on independent experience and knowledge of the patient , to determine the best course of treatment for the patient . Accordingly , adherence to any PCO is voluntary , with the ultimate determination regarding its application to be made by the physician in light of each patient 's individual circumstances . ASCO PCOs describe the use of procedures and therapies in clinical trials and can not be assumed to apply to the use of these interventions in the context of clinical practice . ASCO assumes no responsibility for any injury or damage to persons or property arising out of
Output:
| RECOMMENDATIONS Endocrine therapy is preferable to chemotherapy as first-line treatment for patients with estrogen receptor-positive metastatic breast cancer unless improvement is medically necessary ( eg , immediately life-threatening disease ) .
Single agent is preferable to combination chemotherapy , and longer planned duration improves outcome but must be balanced against toxicity .
Other targeted therapies have not so far been shown to enhance chemotherapy outcome in HER2-negative breast cancer |
MS213240 | ***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: CONTEXT Education in simulated learning environments ( SLEs ) has grown rapidly across health care professions , yet no substantive r and omised controlled trial ( RCT ) has investigated whether SLEs can , in part , substitute for traditional clinical education . METHODS Participants were physiotherapy students ( RCT 1 , n = 192 ; RCT 2 , n = 178 ) from six Australian universities undertaking clinical education in an ambulatory care setting with patients with musculoskeletal disorders . A simulated learning programme was developed as a replica for clinical education in musculoskeletal practice to replace 1 week of a 4-week clinical education placement . Two SLE models were design ed . Model 1 provided 1 week in the SLE , followed by 3 weeks in clinical immersion ; Model 2 offered training in the SLE in parallel with clinical immersion during the first 2 weeks of the 4-week placement . Two single-blind , multicentre RCTs ( RCT 1 , Model 1 ; RCT 2 , Model 2 ) were conducted using a non-inferiority design to determine if the clinical competencies of students part-educated in SLEs would be any worse than those of students educated fully in traditional clinical immersion . The RCTs were conducted simultaneously , but independently . Within each RCT , students were stratified on academic score and r and omised to either the SLE group or the control ( ' Traditional ' ) group , which undertook 4 weeks of traditional clinical immersion . The primary outcome measure was a blinded assessment of student competency conducted over two clinical examinations at week 4 using the Assessment of Physiotherapy Practice ( APP ) tool . RESULTS Students ' achievement of clinical competencies was no worse in the SLE groups than in the Traditional groups in either RCT ( Margin [ Δ ] ≥ 0.4 difference on APP score ; RCT 1 : 95 % CI - 0.07 to 0.17 ; RCT 2 : 95 % CI - 0.11 to 0.16 ) . CONCLUSIONS These RCTs provide evidence that clinical education in an SLE can in part ( 25 % ) replace clinical time with real patients without compromising students ' attainment of the professional competencies required to practise OBJECTIVE The purpose of this study was to investigate a quantitative biomechanical evaluation method for contact forces exerted during a manual examination and treatment technique used in a learning environment . The evaluation was based on three-dimensional ( 3D ) force component data . METHODS A h and -/palm-held computerized 3D force component measuring system was used during a simple feedback experiment involving 20 second-year university students of physiotherapy who delivered 5 sets of grade d perpendicular manual push forces on the sensor part of the system , which was placed on the padded surface of an examination/treatment table . In an effect study with a multiple time-series design , a r and omly chosen subgroup of subjects received concurrent visual 3D kinetic/dynamic force-time feedback . RESULTS The students delivered grade d perpendicular forces with good intrasubject consistency ( intraclass correlation coefficient [ 3 , 1 ] : mean , 0.80 ; range , 0.76 - 0.88 ) but with poor intersubject consistency ( intraclass correlation coefficient [ 2 , 1 ] : mean , 0.38 ; range , 0.15 - 0.74 ) . A temporary performance improvement in forward-backward force direction deviations from the perpendicular in the subgroup given feedback indicates that students are sensitive to feedback training . CONCLUSION An evaluation tool using 3D contact force component measurement enables the assessment of the overall magnitude of the manual contact force as well as its directional aspect . Compared with existing evaluations based on 1-dimensional force components , this 3D system allows for a more complete and , at the same time , more specific quantitative evaluation of the manual contact forces . Three-dimensional dynamic/kinetic augmented feedback has the additional potential of helping students and practitioners to improve their palpation and force delivery skills This study was design ed to investigate whether concurrent quantitative feedback of performance could improve the learning of a joint mobilization technique . A group of 110 physical therapy students had been r and omly divided into two groups for teaching purpose s. All students had previously learned mobilization of peripheral joints and were currently learning spinal mobilization . From one of the groups , 22 students volunteered to comprise a control group , which was taught a spinal mobilization technique in the traditional way . Additional concurrent quantitative feedback of the level of force applied to the patient was given to 31 volunteers from the other group . These students formed the experimental group . A force plate was used for force measurement , and the feedback was given via an oscilloscope . The average force applied by the students ' instructors was taken as an " ideal " force . The oscilloscope showed both the applied force and the " ideal " force . Consistency was measured by the variance of the group 's performance . Accuracy was assessed by calculating the difference between the applied force and the " ideal " force . Results indicated that this feedback was associated with a significant improvement in accuracy and consistency in the application of the mobilizing force . This improvement was still present at a follow-up test conducted one week later . This result supports a greater use of such feedback in the teaching and practice of joint mobilization techniques , although the need for further research is emphasized Introduction Simulated learning environments ( SLEs ) are used worldwide in health professional education , including physiotherapy , to train certain attributes and skills . To date , no r and omized controlled trial ( RCT ) has evaluated whether education in SLEs can partly replace time in the clinical environment for physiotherapy cardiorespiratory practice . Methods Two independent single-blind multi-institutional RCTs were conducted in parallel using a noninferiority design . Participants were volunteer physiotherapy students ( RCT 1 , n = 176 ; RCT 2 , n = 173 ) entering acute care cardiorespiratory physiotherapy clinical placements . Two SLE models were investigated as follows : RCT 1 , 1 week in SLE before 3 weeks of clinical immersion ; RCT 2 , 2 weeks of interspersed SLE/ clinical immersion ( equivalent to 1 SLE week ) within the 4-week clinical placement . Students in each RCT were stratified on academic grade and r and omly allocated to an SLE plus clinical immersion or clinical immersion control group . The primary outcome was competency to practice measured in 2 clinical examinations using the Assessment of Physiotherapy Practice . Secondary outcomes were student perception of experience and clinical educator and patient rating of student performance . Results There were no significant differences in student competency between the SLE and control groups in either RCT , although students in the interspersed group ( RCT 2 ) achieved a higher score in 5 of 7 Assessment of Physiotherapy Practice st and ards ( all P < 0.05 ) . Students rated the SLE experience positively . Clinical educators and patients reported comparability between groups . Conclusions An SLE can replace clinical time in cardiorespiratory physiotherapy practice . Part education in the SLE satisfied clinical competency requirements , and all stakeholders were satisfied UNLABELLED The purpose of this study was to determine whether providing physical therapy ( PT ) students with instructions in proper ultrasound ( US ) pressure application would result in more optimal pressures compared with pressures obtained by students who were not instructed . Previous research determined that for transmission to be adequate , optimal pressure must be 600 g. A sample of convenience of PT students in our program participated in this study . Students were divided into two groups : 31 first-year students who were instructed ( group 1 ) and 34 third-year students who were not instructed ( group 2 ) in US pressure application . METHODS The students who were trained in this new parameter did so as part of the electromodalities course and were compared with untrained third-year students . Group 1 received specific verbal instructions during laboratory , and then performed the US to a gel pad placed on top of a digital scale while observing the digital pressure readout for feedback . This group was retested 7 months later to determine retention of skill acquisition . For data collection , all students applied US for 5 minutes with pressures recorded every 30 seconds and were blinded to the readout . The group without instructions had a mean pressure of 321.92 g ( SD , 257.82 ) , and the group with instructions had a mean of 607.29 g ( SD , 145.52 ) 4 weeks after training . The difference between means was significant ( t[60.4 ] = 8.54 , p < 0.000 ) . Follow-up scores 7 months later for group 1 showed a mean of 587.23 g ( SD , 284.17 ) , not significantly different from the first measurements ( p = 0.807 ) . The results showed a significant difference between groups , whereby students who received instructions outperformed those who did not , overall were more accurate in their perception of US pressure , and showed good retention skills , reaffirming that feedback is a valuable learning tool . For US to be effective , proper pressure must be exerted , and this should be a parameter instructed in schools where US is taught to improve treatment effectiveness Background and Purpose Joint mobilization is a complicated task to learn and to teach and is characterized by great intersubject variability . This study 's purpose was to investigate whether quantitatively augmented feedback could enhance the learning of joint mobilization and , more specifically , to compare the effects of training with concurrent or terminal feedback by using a joint translation simulator ( JTS ) . Subjects Thirty-six undergraduate physical therapist students were r and omly assigned to control ( no feedback ) , concurrent feedback , and terminal feedback groups . Methods The JTS was design ed to simulate tissue resistance based on load-displacement relationships of glenohumeral joint specimens . Subjects applied specific mobilization grade s of force on the JTS while quantitative feedback was given to the feedback groups either during a trial ( ie , concurrent feedback ) or after a trial ( ie , terminal feedback ) . The skill acquisition phase lasted a total of 40 minutes , and a total of 75 repetitions were performed for each grade of each joint model . Pretest and no-feedback retention tests were conducted . Results During acquisition and retention , both feedback groups performed more accurately than did the control group . No obviously superior performance was shown by the terminal feedback group compared with concurrent feedback group during retention testing . Discussion and Conclusion Subjects who trained with augmented feedback had less variability , and thus more consistency , than the control group subjects who received no feedback . Augmented feedback provides the student with a reference force and the status of his or her performance . The effectiveness of the JTS feedback compared with no feedback was clearly demonstrated . Skill acquisition in mobilization can be enhanced by either concurrent or terminal feedback Purpose To evaluate the effectiveness of a novel , simulation-based educational model rooted in scaffolding theory that capitalizes on a systematic progressive sequence of simulators that increase in realism ( i.e. , fidelity ) and information content . Method Forty-five medical students were r and omly assigned to practice intravenous catheterization using high-fidelity training , low-fidelity training , or progressive training from low to mid to high fidelity . One week later , participants completed a transfer test on a st and ardized patient simulation . Blinded expert raters assessed participants ' global clinical performance , communication , procedure documentation , and technical skills on the transfer test . Participants ' management of the re sources available during practice was also recorded . Data were analyzed using multivariate analysis of variance . The study was conducted in fall 2008 at the University of Toronto . Results The high-fidelity group scored higher ( P < .05 ) than the low-fidelity group on all measures except procedure documentation . The progressive group scored higher ( P < .05 ) than other groups for documentation and global clinical performance and was equivalent to the high-fidelity group for communication and technical skills . Total practice time was greatest for the progressive group ; however , this group required little practice time on the re source -intensive high-fidelity simulator . Conclusions Allowing students to progress in their practice on simulators of increasing fidelity led to superior transfer of a broad range of clinical skills . Further , this progressive group was re source -efficient , as participants concentrated on lower fidelity and lower re source -intensive simulators . It is suggested that clinical training curricula incorporate exposure to multiple simulators to maximize educational benefit and potentially save educator time
Output:
| While there were few r and omized controlled trials with vali date d outcome measures , some discoveries about simulation can positively affect the design of the PT entry-to- practice curricula .
Using simulators to provide specific output feedback can help students learn specific skills .
Computer simulations can also augment students ' learning experience .
Human simulation experiences in managing the acute patient in the ICU are well received by students , positively influence their confidence , and decrease their anxiety .
There is evidence that simulated learning environments can replace a portion of a full-time 4-week clinical rotation without impairing learning .
CONCLUSIONS Simulation-based learning activities are being effectively incorporated into PT curricula . |
MS213241 | ***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: Blood pressure reactivity is enhanced in young black subjects through mechanisms that are poorly understood . We compared & agr;-adrenergic – mediated vasoconstrictor and & bgr;-adrenergic vasodilator sensitivity and their relation to sympathetic activity in blacks and whites . Ten healthy black ( age , 29.9±2.4 years ) and 10 white ( age , 28.3±1.9 years ) men were studied . Forearm blood flow was measured with strain-gauge plethysmography after the intrabrachial artery administration of phenylephrine ( 1.25 to 20 & mgr;g/min ) and isoproterenol ( 60 and 400 ng/min ) after application of lower-body negative pressure and after a cold pressor test . Forearm and systemic norepinephrine spillover were measured with a radioisotope dilution technique . & agr;-Adrenergic vasoconstriction was markedly increased ( ANOVA P = 0.008 ) and & bgr;-adrenergic vasodilation decreased ( ANOVA P = 0.02 ) in blacks . Phenylephrine ( 10 & mgr;g/min ) decreased forearm blood flow by 58.0±2.5 % in blacks but only by 26.6±6.0 % in whites ( P < 0.001 ) . Vasoconstrictor response to endogenous norepinephrine , stimulated by a cold pressor test , result ed in a higher forearm vascular resistance in blacks than in whites ( 107.3±13 versus 64.8±13 mm Hg · mL−1 · 100 mL−1 , P = 0.03 ) . There were no significant ethnic differences in basal or stimulated forearm or systemic norepinephrine spillover . Increased vasoconstrictor and decreased vasodilator responses in blacks were not correlated . Increased sympathetically mediated vascular tone caused by enhanced vasoconstriction and attenuated vasodilation , effects that would be additive , and not increased sympathetic activity could enhance vascular reactivity and may play a role in the pathogenesis of hypertension in blacks Presentation , response to therapy , and clinical outcome in hypertension differ according to race , and these observations could relate to differences in microvascular function . We examined forearm microvascular function in age-matched black ( n=56 ) and white subjects ( n=62 ) using intra-arterial agonist infusion and venous occlusion plethysmography . In normotensive subjects ( n=70 ; 34 black and 36 white normotensives ) , methacholine- , sodium nitroprusside- , and verapamil-induced vasodilation was equivalent in black and white subjects . In hypertensive subjects ( n=48 ; 22 black and 26 white hypertensives ) , the vasodilator response to methacholine was markedly lower in black subjects compared with white subjects ( P < 0.001 ) . The vasodilator responses to sodium nitroprusside and verapamil , however , were equivalent in black and white hypertensive subjects . Acute ascorbic acid infusion improved the methacholine response equally in black and white hypertensive patients , suggesting that a difference in a rapidly reversible form of oxidative stress does not explain these findings . Thus , the present study demonstrates important racial differences in vascular function and a marked impairment in endothelial vasomotor function in black patients with hypertension . Further studies will be required to eluci date the mechanisms and determine whether these insights will lead to more appropriately tailored management of hypertension and its complications In this prospect i ve investigation , all children enrolled in the public third- grade classrooms of an entire county ( n=474 ) had blood pressure measured both at rest and during a stressful television video game . Examinations were repeated in 4 subsequent years when cohort children as well as newly enrolled children were in grade s 4 , 5 , 7 , and 8 . Both crosssectional and longitudinal analyses indicated that black children demonstrated significantly greater systolic and diastolic pressor reactivity than white children . These data suggest that ethnic differences in children 's pressor reactivity presage ethnic differences in adulthood hypertension OBJECTIVES To determine arterial elasticity in normotensives and in treated and untreated hypertensive Black and White subjects . METHODS A prospect i ve multicenter , controlled clinical trial evaluated large ( C- ) and small ( C2 ) artery elasticity indices among 3 groups : 1 ) normotensive subjects with or without a family history of hypertension ; 2 ) controlled and treated hypertensive subjects ; and 3 ) untreated and uncontrolled hypertensive subjects . Blood pressure was measured using a mercury manometer and arterial compliance or elasticity was determined using a CVProfilor DO-2020 CardioVascular Profiling System ( Hypertension Diagnostics , Inc , Eagan , Minn ) . These parameters were measured in triplicate 3 minutes apart in a r and om sequence , with the patient in a supine position . Two-way ANOVA was used for statistical evaluation . RESULTS One hundred seventy eight subjects met stratification and enrollment criteria . The mean age was 46 years . 109 were White and 69 were Black . [ table : see text ] CONCLUSION Small and large arterial elasticity indices are reduced as hypertension status worsens . Age and height were important covariates of C1 and C2 . Race was not found to be a significant predictor of either C1 or C2 . Large and small artery elasticity indices do not differ between White and Black subjects with varying degrees of hypertension after adjusting for covariates . More studies with a larger number of subjects are required BACKGROUND Vasodilator reactivity is attenuated in normotensive blacks , and this may contribute to their enhanced susceptibility to hypertension and its complications . However , the mechanisms responsible for this phenomenon are unknown . We therefore studied nitric oxide (NO)-dependent and -independent vasorelaxation in healthy blacks and whites to investigate the nature of racial differences in vasodilator function . METHODS AND RESULTS Forearm flow responses to intra-arterial infusion of increasing doses of acetylcholine ( a vasodilator that stimulates endothelial release of NO ) , sodium nitroprusside ( an exogenous NO donor ) , and isoproterenol ( a beta-adrenergic agonist whose vasodilator effect stems from the combination of direct smooth muscle stimulation and endothelial NO release ) were studied in 18 normotensive whites and 18 blacks by use of strain-gauge plethysmography . A blunted vasodilator response to acetylcholine ( 7.2+/-1.1 versus 14.4+/-1.8 mL. min-1 . dL-1 ; P<0.001 ) and sodium nitroprusside ( 8.2+/-1.1 versus 12.1+/-1.3 mL. min-1 . dL-1 ; P<0.001 ) was observed in blacks compared with whites , suggesting decreased cGMP-mediated smooth muscle relaxation . The vasodilator effect of isoproterenol was lower in blacks than in whites both before ( 10.9+/-1.7 versus 14.9+/-1.5 mL. min-1 . dL-1 ; P=0.006 ) and after NG-monomethyl-L-arginine ( 6.1+/-1.2 versus 10 . 1+/-0.8 mL. min-1 . dL-1 ; P<0.001 ) , implying that cAMP-dependent vasodilator response to isoproterenol is diminished in blacks . No significant difference was observed in the hyperemic response to forearm ischemia . CONCLUSIONS Compared with whites , healthy blacks have reduced vasodilation in response to NO-dependent and -independent stimuli . This difference seems to be related to an attenuation in cyclic nucleotide-mediated vascular smooth muscle relaxation and may play a role in the increased prevalence of hypertension and its complications in blacks The health and life expectancy of Americans has dramatically improved during the past several decades , but racial and ethnic minorities have not benefited equally from this progress . Differences in health outcomes between majority and minority population s , commonly referred to as racial or ethnic disparities in health , are the result of several factors operating in complex sociologic , cultural , political , economic , and health care context s. Until recently , curricula addressing racial and ethnic health disparities focused on factors outside the health care system , including socioeconomic disadvantage and lack of health insurance ( 1 ) , but some publications ( 25 ) , culminating in 2002 with the Institute of Medicine report , Unequal Treatment : Confronting Racial and Ethnic Disparities in Health Care , have highlighted the fact that racial and ethnic minoritieseven those with equivalent access to the health care systemreceive lower- quality care than white patients for many medical conditions ( 6 ) . As a result , increased attention is now focused on addressing racial and ethnic disparities in health care ( hereafter referred to as health care disparities ) as a component of addressing racial and ethnic disparities in health ( hereafter referred to as health disparities ) ( 7 , 8) . Emerging consensus among national experts suggests that without new and more effective interventions , health disparities will be difficult to eliminate ( 9 ) , and they may become an even larger problem as racial and ethnic minorities become a larger proportion of the U.S. population ( 10 ) . Key stakeholders need to engage at many levels to eliminate disparities , including at the community and societal levels . However , considering the significance of the physicianpatient relationship in health care delivery , interventions by individual physicians will be an important component of an overall strategy to reduce health care disparities . Several surveys show that many physicians remain unaware of health care disparities nationally and in their own practice s ( 1113 ) . The Institute of Medicine 's report recommends that health professionals receive training to better underst and and address disparities ( 6 ) . However , few curricula on health disparities exist , and there are no well-accepted guidelines on what and how to teach about this complex topic . This report presents the work of the Society of General Internal Medicine Health Disparities Task Force to develop guidelines for medical education on disparities in health and health care . We provide learning objectives , suggested content , methods for teaching , and a set of current re sources . Although they were developed primarily for teaching medical students , residents , and practitioners in primary care , our general recommendations should apply to learners in any specialty . The Task Force has also developed recommendations for system-level and environment-of-care interventions to eliminate health care disparities , which are as important as recommendations for training individual practitioners but are beyond the scope of this report . Methods The Society of General Internal Medicine is an international organization that comprises internal medicine physicians and others who combine patient care with education and research in primary care internal medicine . The Task Force includes volunteers from the Society of General Internal Medicine membership , many of whom teach about ethics , health disparities , and cross-cultural care at their institutions . The Task Force convened a series of meetings from 2002 to 2005 , which included several conference calls , e-mail exchanges , and 4 face-to-face meetings . After the first meeting , Task Force teams completed a needs assessment and literature review . The entire Task Force then contributed to several versions of the recommendations . Subsequent meetings served to refine and tailor iterative versions of both the literature review and recommendations , which informed each other . Final recommendations were developed by a consensus , although various interpretations remain among members of the Task Force in the application of specific principles . Needs Assessment Few studies have formally assessed the need for health disparities training . Recent surveys on cross-cultural care demonstrate that resident physicians ' self-reported preparedness to deliver cross-cultural care lags well behind preparedness in other clinical and technical areas ( 14 , 15 ) . A national study on resident physicians reported that residents were receiving the message that health care disparities are important and that physicians should play a role in eliminating them , but they had not received guidance on how to do so . As a result , they developed coping behaviors rather than skills ( 16 ) . To supplement these studies , the Task Force conducted its own brief needs assessment survey with the assistance of the Institute for Ethics at the American Medical Association . The survey was sent to 60 r and omly selected internal medicine program directors nationwide , 22 of whom responded within the 1-month time frame ( 37 % response rate ) . Most of the 22 respondents ( 86 % ) reported teaching some information about health disparities , and none reported offering a lot of training . However , 77 % agreed that learning about health disparities was associated with better quality of care , and 73 % reported that a resident 's level of interest was not a barrier to teaching : health disparities . Rather , shortages of qualified faculty and lack of st and ardized curricula were often noted as barriers . Adding to the need for concrete guidance in this domain , the Liaison Committee on Medical Education , which sets st and ards for undergraduate medical education , required in 2004 that medical schools document objectives relating to the development of skills in cultural competence , indicate where in the curriculum students are exposed to such material , and demonstrate the extent to which the objectives are being achieved ( 17 ) . The Accreditation Council on Graduate Medical Education , which accredits residency training programs , has also included cultural sensitivity as a skill set in its core competencies for residency training : Programs must teach and monitor residents ' ability to demonstrate sensitivity and responsiveness to patients ' culture , age , gender , and disabilities ( 18 ) . The American Board of Medical Specialties and the Accreditation Council on Graduate Medical Education have created a toolbox of re sources for monitoring professionalism that includes useful material s for assessing residents in these domains ( 19 ) . Because these accreditation requirements have been implemented , new curricula ( 2022 ) and suggested st and ards for training programs ( 2325 ) have begun to emerge , although none are widely accepted yet . Literature
Output:
| The available data indicate that compared to normotensive whites , normotensive black people have enhanced vascular reactivity to sympathetic stimulation , attenuated responses to vasodilators , and a relatively narrow vascular lumen diameter .
Of these mechanisms , the reduced vasodilation and reduced nitric oxide bioavailability in the vascular wall seem to form the most important distinction between resistance vessel properties of black and white participants |
MS213242 | ***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 effect of a plaster cast socket on the healing of open wounds and on temporary prosthesis fitting after below-knee amputation because of arterial occlusive disease . DESIGN R and omized controlled trial . SETTING Rehabilitation center , university hospital . PATIENTS All included patients had undergone recent ( in the previous 3 months ) below-knee amputation because of arterial disease and initially had an open stump . Patients were r and omly assigned to two groups of 28 subjects each . The sizes of the amputation scars were 8 to 24 cm2 . Ischemia of the stump was eliminated as a probable cause of delayed wound healing by the inclusion criterion of transcutaneous oxygen tension ( TcPO2 ) of > 35 mmHg . The average age in group I ( the experimental group ) was 65.2 + /- 12.4 ( SD ) years and in group II ( the control group ) 66.8 + /- 10.8 years ( not significant ) . INTERVENTION A plaster cast ( supracondylar-type ) socket was fitted on the stumps of group I patients , interposed with a silicone sleeve . The patients were gradually trained to wear this cast for up to 5 hours a day . They were provided with elastic compression b and ages for the remainder of the time . Patients in group II wore elastic compression b and ages , which were only removed for dressing changes . MAIN OUTCOME MEASURES Time required for stump healing , length of time between amputation and ability to walk wearing a contact socket , and length of hospital stay . RESULTS Group I had a quicker average healing time ( 71.2 + /- 31.7 [ SD ] days compared to the control group 's 96.8 + /- 54.9 days ) and a shorter average length of hospital stay ( 99.8 + /- 22.4 days compared to the control group 's 129.9 + /- 48.3 days ) . CONCLUSION Use of a plaster cast socket leads to more rapid healing of the open stump and to a shorter hospitalization . If there is no stump ischemia , this plaster cast technique is safe 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 findings of impaired activity of aryl hydrocarbon hydroxylase in the liver and small bowel of patients with psoriasis . ' The salivary clearances indicate that the inducing effect of smoking on antipyrine metabolism is similar in patients and normal subjects . This contrasts with our observations in skin : so far we have been unable to show any difference in skin activity of aryl hydrocarbon hydroxylase between smokers and non-smokers , and in-vitro induction with benzanthracene of aryl hydrocarbon hydroxylase activity in lesion-free skin of patients with psoriasis is only about 50 % of normal . ' Clearly , in-vivo induction by smoking as measured by antipyrine clearance is not analogous to in-vitro induction by benzanthracene as measured by activity of aryl In this r and omised prospect i ve parallel-group controlled study , a modern cellulose-based fibre dressing was compared with a traditional ribbon gauze and proflavine dressing , used intra- and post-operatively . The study evaluates each treatment for the reduction in pain , improvement in the quality of treatment and patient satisfaction . Forty patients , with wounds left to heal by secondary intention , were studied . The results show several significant advantages for the cellulose-based fibre dressing . Pain levels on removal at the first dressing change were significantly reduced in the cellulose-based fibre dressing group ( p = 0.002 ) ; the ribbon gauze patients routinely required analgesia before removal of the first dressing . At one week , a significantly greater number of patients in the cellulose-based fibre dressing group stated that they would be happy to have their first dressing change carried out at home without analgesia compared to the ribbon gauze group . This would enable patients to be discharged earlier and could represent a considerable financial saving to the hospital A report of a study that examined some clinical characteristics of two commonly used wound PURPOSE The purpose of this study was to investigate the efficacy and safety of recombinant human platelet-derived growth factor ( rhPDGF-BB ) in a double-blind , placebo-controlled , multicenter study of patients with chronic diabetic ulcers . METHODS Patients with chronic , full-thickness , lower-extremity diabetic neurotrophic ulcers of at least 8 weeks ' duration , free of necrotic and infected tissue after debridement , and with transcutaneous oxygen tensions of 30 mm Hg or greater were studied . A total of 118 patients were r and omized to receive either topical rhPDGF-BB ( 2.2 micrograms/cm2 of ulcer area ) or placebo until the ulcer was completely resurfaced or for a maximum of 20 weeks , whichever occurred first . RESULTS Twenty-nine ( 48 % ) of 61 patients r and omized to the rhPDGF-BB group achieved complete wound healing during the study compared with only 14 ( 25 % ) of 57 patients r and omized to the placebo group ( p = 0.01 ) . The median reduction in wound area in the group given rhPDGF-BB was 98.8 % compared with 82.1 % in the group given placebo ( p = 0.09 ) . There were no significant differences in the incidence or severity of adverse events between the rhPDGF-BB and placebo groups . CONCLUSIONS Once-daily topical application of rhPDGF-BB is safe and effective in stimulating the healing of chronic , full-thickness , lower-extremity diabetic neurotrophic ulcers This prospect i ve r and omised trial compared the performance of three dressing protocol s in the management of 36 dehisced surgical abdominal wounds : a st and ard alginate ; a gauze moistened with sodium hypochlorite ( 0.05 % ) ; and a combine dressing pad . Outcomes assessed were : healing time ( cm2 per day and cm3 per day ) , patient comfort ( pain and satisfaction ) and cost . There were no statistically significant differences in healing rates between the three groups but there was a trend for the combine dressing pad protocol to produce a greater reduction in wound area . The combine dressing pad protocol performed well when compared with the calcium alginate in terms of healing time , patient comfort and cost . Maximum pain was significantly greater ( p = 0.011 ) and satisfaction significantly lower among patients who received the sodium hypochlorite protocol . Costs during the in-patient phase were also substantially higher for the sodium hypochlorite protocol . Trial results support the view that sodium hypochlorite dressing protocol s for surgical wounds should be ab and oned This trial was undertaken to examine the safety and efficacy of four-layer compared with short stretch compression b and ages for the treatment of venous leg ulcers within the confines of a prospect i ve , r and omised , ethically approved trial . Fifty-three patients were recruited from a dedicated venous ulcer assessment clinic and their individual ulcerated limbs were r and omised to receive either a four-layer b and age (FLB)(n = 32 ) or a short stretch b and age (SSB)(n = 32 ) . The endpoint was a completely healed ulcer . However , if after 12 weeks of compression therapy no healing had been achieved , that limb was withdrawn from the study and deemed to have failed to heal with the prescribed b and age . Leg volume was measured using the multiple disc model at the first b and aging visit , 4 weeks later , and on ulcer healing . Complications arising during the study were recorded . Data from all limbs were analysed on an intention to treat basis ; thus the three limbs not completing the protocol were included in the analysis . Of the 53 patients , 50 completed the protocol . At 1 year the healing rate was FLB 55 % and SSB 57 % ( chi 2 = 0.0 , df = 1 , P = 1.0 ) . Limbs in the FLB arm of the study sustained one minor complication , whereas SSB limbs sustained four significant complications . Leg volumes reduced significantly after 4 weeks of compression , but subsequent volume changes were insignificant . Ulcer healing rates were not influenced by the presence of deep venous reflux , post-thrombotic deep vein changes nor by ulcer duration . Although larger ulcers took longer to heal , the overall healing rates for large ( > 10 cm2 ) and small ( 10 cm2 or less ) ulcers were comparable . Four-layer and short stretch b and ages were equally efficacious in healing venous ulcers independent of pattern of venous reflux , ulcer area or duration . FLB limbs sustained fewer complications than SSB The treatment of established hidradenitis suppurativa dem and s complete excision of the apocrine gl and s in the affected area . Ten patients undergoing bilateral excision of the axillary skin , had one axilla grafted and the other allowed to heal by granulation utilising Silastic foam dressing , in order to compare the two methods . Split skin grafting result ed in more rapid healing of the excised area than healing by secondary intention . However , Silastic foam dressing result ed in certain healing with a good cosmetic result and avoided the need for immobilisation and a painful donor site . Most patients in this series preferred Silastic foam dressing to skin grafting After nail matrix ablation using phenolization , a medicated wound dressing ( 10 % povidone iodine ) , an amorphous hydrogel dressing ( Intrasite Gel ) , and a control dressing ( paraffin gauze ) were evaluated . Forty-two participants , r and omly divided into three dressing groups , were evaluated . Healing time did not differ between the 10 % povidone iodine ( 33 days ) , amorphous hydrogel ( 33 days ) , and the control dressing ( 34 days ) . For all groups , the clinical infection rate was lower than in previous studies , and there was no clinical difference between groups ( one infection in the povidone iodine and control groups ; none in the amorphous hydrogel group ) . However , in the amorphous hydrogel group , other complications , such as hypergranulation , were more likely . This investigation indicated that medicated or hydrogel dressings did not enhance the rate of healing or decrease infection rates Calcium alginate dressings have been used in the treatment of pressure ulcers and leg ulcers . This study analyzes the effectiveness of a calcium alginate dressing in wound exu date absorption , patient comfort , and ease of application OBJECTIVE We assessed in a r and omized prospect i ve trial the effectiveness of Graftskin , a living skin equivalent , in treating noninfected nonischemic chronic plantar diabetic foot ulcers . RESEARCH DESIGN AND METHODS In 24 centers in the U.S. , 208 patients were r and omly assigned to ulcer treatment either with Graftskin ( 112 patients ) or saline-moistened gauze ( 96 patients , control group ) . St and ard state-of-the-art adjunctive therapy , which included extensive surgical debridement and adequate foot off-loading , was provided in both groups . Graftskin was applied at the beginning of the study and weekly thereafter for a maximum of 4 weeks ( maximum of five applications ) or earlier if complete healing occurred . The major outcome of complete wound healing was assessed by intention to treat at the 12-week follow-up visit . RESULTS At the 12-week follow-up visit , 63 ( 56 % ) Graftskin-treated patients achieved complete wound healing compared with 36 ( 38 % ) in the control group ( P = 0.0042 ) . The Kaplan-Meier median time to complete closure was 65 days for Graftskin , significantly lower than the 90 days observed in the control group ( P = 0.0026 ) . The odds ratio for complete healing for a Graftskin-treated ulcer compared with a control-treated ulcer was 2.14 ( 95 % CI 1.23 - 3.74 ) . The rate of adverse reactions was similar between the two groups with the exception of osteomyelitis and lower-limb amputations , both of which were less frequent in the Graftskin group . CONCLUSIONS Application of Graftskin for a maximum of 4 weeks results in a higher healing rate when compared with state-of-the-art currently available treatment and is not associated with any significant side effects . Graftskin may be a very useful adjunct for the management of diabetic foot ulcers that are resistant to the currently available st and ard of care Many conventional dressings are painful when removed , and may be detrimental to healing . In
Output:
| REVIEW ERS ' CONCLUSIONS We found only small , poor quality trials ; the evidence is therefore insufficient to determine whether the choice of dressing or topical agent affects the healing of surgical wounds healing by secondary intention .
Foam is best studied as an alternative for gauze and appears to be preferable as to pain reduction , patient satisfaction and nursing time |
MS213243 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Background Although lifestyle interventions targeting multiple lifestyle behaviors are more effective in preventing unhealthy weight gain and chronic diseases than intervening on a single behavior , few studies have compared individual and combined effects of diet and /or exercise interventions on health-related quality of life ( HRQOL ) . In addition , the mechanisms of how these lifestyle interventions affect HRQOL are unknown . The primary aim of this study was to examine the individual and combined effects of dietary weight loss and /or exercise interventions on HRQOL and psychosocial factors ( depression , anxiety , stress , social support ) . The secondary aim was to investigate predictors of changes in HRQOL . Methods This study was a r and omized controlled trial . Overweight/obese postmenopausal women were r and omly assigned to 12 months of dietary weight loss ( n = 118 ) , moderate-to-vigorous aerobic exercise ( 225 minutes/week , n = 117 ) , combined diet and exercise ( n = 117 ) , or control ( n = 87 ) . Demographic , health and anthropometric information , aerobic fitness , HRQOL ( SF-36 ) , stress ( Perceived Stress Scale ) , depression [ Brief Symptom Inventory (BSI)-18 ] , anxiety ( BSI-18 ) and social support ( Medical Outcome Study Social Support Survey ) were assessed at baseline and 12 months . The 12-month changes in HRQOL and psychosocial factors were compared using analysis of covariance , adjusting for baseline scores . Multiple regression was used to assess predictors of changes in HRQOL . Results Twelve-month changes in HRQOL and psychosocial factors differed by intervention group . The combined diet + exercise group improved 4 aspects of HRQOL ( physical functioning , role-physical , vitality , and mental health ) , and stress ( p ≤ 0.01 vs. controls ) . The diet group increased vitality score ( p < 0.01 vs. control ) , while HRQOL did not change differently in the exercise group compared with controls . However , regardless of intervention group , weight loss predicted increased physical functioning , role-physical , vitality , and mental health , while increased aerobic fitness predicted improved physical functioning . Positive changes in depression , stress , and social support were independently associated with increased HRQOL , after adjusting for changes in weight and aerobic fitness . Conclusions A combined diet and exercise intervention has positive effects on HRQOL and psychological health , which may be greater than that from exercise or diet alone . Improvements in weight , aerobic fitness and psychosocial factors may mediate intervention effects on HRQOL.Trial Registration Clinical Trials , Clinical Trials.gov register , Background : The impact of dietary flavonoid intakes on risk of depression is unclear . Objective : We prospect ively examined associations between estimated habitual intakes of dietary flavonoids and depression risk . Design : We followed 82,643 women without a previous history of depression at baseline from the Nurses ’ Health Study [ ( NHS ) aged 53–80 y ] and the Nurses ’ Health Study II [ ( NHSII ) aged 36–55 y ] . Intakes of total flavonoids and subclasses ( flavonols , flavones , flavanones , anthocyanins , flavan-3-ols , polymeric flavonoids , and proanthocyanidins ) were calculated from vali date d food-frequency question naires collected every 2–4 y. Depression was defined as physician- or clinician-diagnosed depression or antidepressant use and was self-reported in response to periodic question naires . Cox proportional hazards models were performed to examine associations . Results : A total of 10,752 incident depression cases occurred during a 10-y follow-up . Inverse associations between flavonol , flavone , and flavanone intakes and depression risk were observed . Pooled multivariable-adjusted HRs ( 95 % CIs ) were 0.93 ( 0.88 , 0.99 ) , 0.92 ( 0.86 , 0.98 ) , and 0.90 ( 0.85 , 0.96 ) when comparing the highest ( quintile 5 ) with the lowest ( quintile 1 ) quintiles , respectively , with evidence of linear trends across quintiles ( P-trend = 0.0004–0.08 ) . In flavonoid-rich food-based analyses , the HR was 0.82 ( 95 % CI : 0.74 , 0.91 ) among participants who consumed ≥2 servings citrus fruit or juices/d compared with < 1 serving/wk . In the NHS only , total flavonoids , polymers , and proanthocyanidin intakes showed significantly ( 9–12 % ) lower depression risks . In analyses among late-life NHS participants ( aged ≥65 y at baseline or during follow-up ) , for whom we were able to incorporate depressive symptoms into the outcome definition , higher intakes of all flavonoid subclasses except for flavan-3-ols were associated with significantly lower depression risk ; flavones and proanthocyanidins showed the strongest associations ( HR for both : 0.83 ; 95 % CI : 0.77 , 0.90 ) . Conclusions : Higher flavonoid intakes may be associated with lower depression risk , particularly among older women . Further studies are needed to confirm these associations Objectives : We investigated whether a Mediterranean-style diet ( MedDiet ) supplemented with fish oil can improve mental health in adults suffering depression . Methods : Adults with self-reported depression were r and omized to receive fortnightly food hampers and MedDiet cooking workshops for 3 months and fish oil supplements for 6 months , or attend social groups fortnightly for 3 months . Assessment s at baseline , 3 and 6 months included mental health , quality of life ( QoL ) and dietary question naires , and blood sample s for erythrocyte fatty acid analysis . Results : n = 152 eligible adults aged 18–65 were recruited ( n = 95 completed 3-month and n = 85 completed 6-month assessment s ) . At 3 months , the MedDiet group had a higher MedDiet score ( t = 3.95 , P < 0.01 ) , consumed more vegetables ( t = 3.95 , P < 0.01 ) , fruit ( t = 2.10 , P = 0.04 ) , nuts ( t = 2.29 , P = 0.02 ) , legumes ( t = 2.41 , P = 0.02 ) wholegrains ( t = 2.63 , P = 0.01 ) , and vegetable diversity ( t = 3.27 , P < 0.01 ) ; less unhealthy snacks ( t = −2.10 , P = 0.04 ) and red meat/chicken ( t = −2.13 , P = 0.04 ) . The MedDiet group had greater reduction in depression ( t = −2.24 , P = 0.03 ) and improved mental health QoL scores ( t = 2.10 , P = 0.04 ) at 3 months . Improved diet and mental health were sustained at 6 months . Reduced depression was correlated with an increased MedDiet score ( r = −0.298 , P = 0.01 ) , nuts ( r = −0.264 , P = 0.01 ) , and vegetable diversity ( r = −0.303 , P = 0.01 ) . Other mental health improvements had similar correlations , most notably for increased vegetable diversity and legumes . There were some correlations between increased omega-3 , decreased omega-6 and improved mental health . Discussion : This is one of the first r and omized controlled trials to show that healthy dietary changes are achievable and , supplemented with fish oil , can improve mental health in people with depression Older individuals with emotional distress and a history of psychologic trauma are at risk for post traumatic stress disorder ( PTSD ) and major depression . This study was an exploratory , secondary analysis of data from the study " Prevention of Depression in Older African Americans " . It examined whether Problem Solving Therapy- Primary Care ( PST-PC ) would lead to improvement in PTSD symptoms in patients with subsyndromal depression and a history of psychologic trauma . The control condition was dietary education ( DIET ) . Participants ( n=60 ) were age 50 or older with scores on the Center for Epidemiologic Studies -Depression scale of 11 or greater and history of psychologic trauma . Exclusions stipulated no major depression and substance dependence within a year . Participants were r and omized to 6 - 8 sessions of either PST-PC or DIET and followed 2 years with booster sessions every 6 months ; 29 participants were in the PST-PC group and 31 were in the DIET group . Mixed effects models showed that improvement of PTSD Check List scores was significantly greater in the DIET group over two years than in the PST-PC group ( based on a group time interaction ) . We observed no intervention⁎time interactions in Beck Depression Inventory or Brief Symptom Inventory-Anxiety subscale scores PURPOSE To conduct a clinical trial to determine if an educational intervention and a nutritional intervention could enhance physical and psychological functioning among younger women completing treatment for early-stage breast cancer . PATIENTS AND METHODS Younger women ( 50 years of age or younger , N = 252 ) , within 2 months of having completed active nonhormonal adjuvant therapy , diagnosed with stage 0 , I , or II breast cancer with 10 or fewer positive lymph nodes were r and omly assigned to a three-arm clinical trial . Women in the control arm of the trial received st and ard medical care . Women in the two active arms received either an educational intervention , design ed to provide information about their illness and enhance adjustment , or a nutritional intervention , design ed to promote a more healthy diet . Primary end points included mental functioning , physical functioning , and depressive symptoms . Women were assessed before r and om assignment , 4 months later ( immediately post-intervention ) , and 13 months later ( 9 months post-intervention ) . RESULTS Participants assigned to the two active treatment arms had significantly less depressive symptomatology and better physical functioning by 13-month follow-up ( differences between the two active arms were nonsignificant ) . These effects were primarily accounted for by changes in intrusive thoughts , concerns regarding cancer recurrence and mortality , self-concept perceptions , and self-efficacy expectations . CONCLUSION Tailored psychosocial interventions can be effectively design ed to enhance adjustment among younger women who are completing nonhormonal adjuvant therapy BACKGROUND Intensive dietary intervention programs may lead to benefits in vitality and other components of health quality . The Women 's Health Initiative Dietary Modification ( DM ) intervention includes a large r and omized controlled trial of an intensive intervention . OBJECTIVE To evaluate whether the intervention is associated with improved health-related quality of life ( HRQoL ) subscales , overall self-reported health , depression symptoms , cognitive functioning , and sleep quality . DESIGN This r and omized controlled trial was analyzed as intent to treat . PARTICIPANTS Between 1993 and 1998 , 48,835 women aged 50 to 79 years were recruited by 40 clinical centers across the United States . Eligibility included having fat intake at baseline ≥32 % of total calories , and excluded women with any prior colorectal or breast cancer , recent other cancers , type 1 diabetes , or medical conditions with predicted survival <3 years . INTERVENTION Goals were to reduce calories from fat to 20 % , increase vegetables and fruit to 5 + servings , and increase grain servings to 6 + servings a day . During the first year , 18 group sessions were held , with quarterly sessions thereafter . MAIN OUTCOME MEASURES The R AND 36-Item Health Survey was used to assess HRQoL at baseline , Year 1 , and close-out ( about 8 years postr and omization ) , and estimate differential HRQoL subscale change scores . STATISTICAL ANALYSES PERFORMED Mean change in HRQoL scores ( Year 1 minus baseline ) were compared by r and omization group using linear models . RESULTS At 1 year , there was a differential change between intervention and comparison group of 1.7 units ( 95 % CI 1.5 , 2.0 ) in general health associated with the intervention . DM intervention improved physical functioning by 2.0 units ( 95 % CI 1.7 , 2.3 ) , vitality by 1.9 units ( 95 % CI 1.6 , 2.2 ) , and global quality of life by 0.09 units ( 95 % CI 0.07 , 0.12 ) . With the exception of global quality of life , these effects were significantly modified by body mass index at baseline . CONCLUSIONS DM intervention was associated with small , but significant improvements in three HRQoL subscales : general health , physical functioning , and vitality at 1 year follow-up , with the largest improvements seen in the women with the greatest baseline body mass index Background The possible therapeutic impact of dietary changes on existing mental illness is largely unknown . Using a r and omised controlled trial design , we aim ed to investigate the efficacy of a dietary improvement program for the treatment of major depressive episodes . Methods ‘ SMILES ’ was a 12-week , parallel-group , single blind , r and omised controlled trial of an adjunctive dietary intervention in the treatment of moderate to severe depression . The intervention consisted of seven individual nutritional consulting sessions delivered by a clinical dietician
Output:
| Studies with female sample s observed significantly greater benefits from dietary interventions , for symptoms of both depression and anxiety .
Conclusions Dietary interventions hold promise as a novel intervention for reducing symptoms of depression across the population . |
MS213244 | ***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: Importance Irritable bowel syndrome ( IBS ) is associated with significant morbidity in children and adolescents , and the therapeutic efficacy of available treatment options is limited . The role of vitamin D supplementation in pediatric IBS is unclear as the vitamin D status of pediatric patients with IBS is unknown . Equally , the relationship of vitamin D status with psychosomatic symptoms in children and adolescents is unclear . Aim To characterize the vitamin D status of pediatric patients with IBS using a case-control study design . Hypothesis Serum 25-hydroxyvitamin D [ 25(OH)D ] concentration will be similar between patients with IBS and controls . Subjects and methods A retrospective case-controlled study of 116 controls ( age 14.6 ± 4.3 y ) , female ( n = 67 ; 58 % ) and 55 subjects with IBS ( age 16.5 ± 3.1y ) , female ( n = 44 ; 80 % ) . Overweight was defined as BMI of ≥85th but < 95th percentile , and obesity as BMI ≥95th percentile . Vitamin D deficiency was defined as 25(OH)D of < 50 nmol/L , while seasons of vitamin D draw were categorized as summer , winter , spring , and fall . Major psychosomatic manifestations included in the analysis were depression , anxiety , and migraine . Results More than 50 % of IBS subjects had vitamin D deficiency at a cut-off point of < 50 nmol/L ( 53 % vs. 27 % , p = 0.001 ) ; and > 90 % of IBS subjects had vitamin D deficiency at a cut-off point of < 75 nmol/L ( 93 % vs. 75 % , p = 0.006 ) . IBS subjects had significantly lower mean 25(OH)D : 53.2 ± 15.8 nmol/L vs. 65.2 ± 28.0 nmol/L , p = 0.003 ; and albumin : 6.2 ± 0.6 vs. 6.5 ± 0.6 μmol/L , p = 0.0.01 . IBS subjects with migraine had significantly lower mean 25(OH)D concentration compared to controls ( p = 0.01 ) . BMI z-score was similar between the controls and IBS subjects ( 0.5 ± 1.4 vs. 1.2 ± 2.9 , p = 0.11 ) . Conclusions Pediatric patients with IBS had significantly lower 25(OH)D concentration compared to controls despite having similar mean BMI values as controls . Only 7 % of the children and adolescents with IBS were vitamin D sufficient , and > 50 % of the subjects with IBS had vitamin D deficiency . This is a much higher prevalence of vitamin D deficiency compared to IBD and other malabsorption syndromes . Monitoring for vitamin D deficiency should be part of the routine care for patients with IBS . R and omized control trials are warranted to determine the role of adjunctive vitamin D therapy in pediatric IBS Background / Aim : Vitamin D deficiency is common in irritable bowel syndrome ( IBS ) . There is growing interest in the role of vitamin D in pediatric IBS . We aim ed to evaluate the effect of vitamin D supplementation in adolescents with IBS and vitamin D deficiency . Patients and Methods : One hundred and twelve adolescents with IBS and vitamin D deficiency were r and omly divided into two groups of matched age and sex . The first group received oral vitamin D3 2000IU/day for 6 months and the second group received placebo for 6 months . Vitamin D status as well as different IBS score systems ( IBS-SSS , IBS-QoL , and total score ) were evaluated before and 6 months after treatment . Results : IBS patients who received vitamin D supplementation for 6 months showed significant improvement in IBS-SSS ( P < 0.001 ) , IBS-QoL ( P < 0.001 ) , and total score ( P = 0.02 ) compared to IBS placebo group . IBS patients treated with vitamin D showed two folds increase in their serum vitamin D levels ( from 17.2 ± 1.3 to 39 ± 3.3 ) ng/ml with P < 0.001 . While in the placebo group , their serum vitamin D levels were not significantly changed ( P = 0.66 ) . Vitamin D was tolerated well without any recorded adverse effects during the study period . Conclusion : Vitamin D supplementation can be effective in treating adolescents with IBS and vitamin D deficiency Background Vitamin D deficiency has been associated or implicated with the pathophysiology of the gastrointestinal conditions inflammatory bowel disease and colorectal cancer , as well as with depression . No trials or epidemiology studies to date have investigated a link with irritable bowel syndrome ( IBS ) . A single case report has suggested a benefit in IBS of vitamin D supplementation . We hypothesised that IBS participants with vitamin D insufficiency would benefit from repletion in terms of their IBS symptoms . We undertook a pilot trial to provide data to support a power calculation and to justify a full trial . Methods This was a r and omised , double blinded , three-arm parallel design trial of vitamin D , placebo or a combination of vitamin D and probiotics . Participants were further stratified according to whether they were vitamin D replete or insufficient . Vitamin D status was determined by blood test at baseline and exit ; IBS symptoms were assessed by vali date d question naire ; dietary intakes were assessed by food frequency question naire . Results A significant proportion of the IBS population were vitamin D deficient , such that the replete stratum could not be adequately recruited . There was a significant association in the baseline data between circulating vitamin D level and quality of life ( “ How much has IBS affected your life ? ” ) . Supplementation significantly improved vitamin D level versus placebo . IBS symptoms were not significantly improved in this pilot , although a power calculation was enabled from the intervention data . Conclusions The IBS population exhibits significant levels of vitamin D insufficiency and would benefit from screening and possible supplementation . The impact of IBS on quality of life may be reduced by vitamin D level . Future trials should have a sample size of over 97 . Trial registration number : ICTRN 6116003917 Background Low vitamin D status is associated with risk of colorectal cancer and has been implicated in inflammatory bowel disease . Irritable bowel syndrome ( IBS ) is a chronic , relapsing , functional bowel disorder . A nascent literature suggests a role for vitamin D in IBS , but this has not been collated or critiqued . To date , seven studies have been published : four observational studies and three r and omised controlled trials ( RCTs ) . All observational studies reported that a substantial proportion of the IBS population was vitamin D deficient . Two intervention studies reported improvement in IBS symptom severity scores and quality of life ( QoL ) with vitamin D supplementation . There are limited data around the role of vitamin D in IBS . Conclusions The available evidence suggests that low vitamin D status is common among the IBS population and merits assessment and rectification for general health reasons alone . An inverse correlation between serum vitamin D and IBS symptom severity is suggested and vitamin D interventions may benefit symptoms . However , the available RCTs do not provide strong , generalisable evidence ; larger and adequately powered interventions are needed to establish a case for therapeutic application of vitamin D in IBS BACKGROUND Low- grade mucosal inflammation and immune activation are involved in the pathogenesis of irritable bowel syndrome ( IBS ) . Furthermore , IBS symptoms are associated with a significantly higher prevalence of psychological distress , which in itself results into an impaired quality of life ( QoL ) . Vitamin D could ameliorate the symptoms of patients suffering from IBS through its beneficial effects on psychological factors and inflammation . METHODS A total of 90 IBS patients participated in this double-blind , r and omized , placebo-controlled study . Participants were r and omly selected to receive either 50 000 IU vitamin D3 or a placebo fortnightly for a period of 6 months . Patients reported their IBS symptoms at the baseline and monthly during intervention periods . The IBS severity score system ( IBSSS ) and IBS-specific QoL question naires were used at the baseline and postintervention . KEY RESULTS Over the 6-month intervention period , a significantly greater improvement in IBS symptoms such as abdominal pain and distention , flatulence , rumbling , and overall gastrointestinal ( GI ) symptoms ( except dissatisfaction with bowel habits ) was observed in the patients receiving vitamin D as compared to the placebo group . The IBSSS and the IBS-QoL scores in the vitamin D group significantly improved compared to the placebo group postintervention ( mean IBSSS score change : -53.82 ± 23.3 vs -16.85 ± 25.01 , p < 0.001 , respectively ; mean IBS-QoL score change : 14.26 ± 3 vs 11 ± 2.34 , p < 0.001 , respectively ) . CONCLUSIONS & INFERENCES Vitamin D seems to be an effective and safe option to improve QoL and symptoms of IBS . Clinical Trials.gov ( NCT02579902 )
Output:
| Conclusions : The findings of this systematic review may provide the existing evidence on the effectiveness and safety of VD for patients with IBS . |
MS213245 | ***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: UNLABELLED Transcutaneous electrical nerve stimulation ( TENS ) is an electrophysical modality used for pain management . This study investigated the dose response of different TENS intensities on experimentally induced pressure pain . One hundred and thirty TENS naïve healthy individuals ( 18 - 64 years old ; 65 males , 65 females ) were r and omly allocated to 5 groups ( n = 26 per group ) : Strong Non Painful TENS ; Sensory Threshold TENS ; Below Sensory Threshold TENS ; No Current Placebo TENS ; and Transient Placebo TENS . Active TENS ( 80 Hz ) was applied to the forearm for 30 minutes . Transient Placebo TENS was applied for 42 seconds after which the current amplitude automatically reset to 0 mA. Pressure pain thresholds ( PPT ) were recorded from 2 points on the h and and forearm before and after TENS to measure hypoalgesia . There were significant differences between groups at both the h and and forearm ( ANOVA ; P = .005 and .002 ) . At 30 minutes , there was a significant hypoalgesic effect in the Strong Non Painful TENS group compared to : Below Sensory Threshold TENS , No Current Placebo TENS and Transient Placebo TENS groups ( P < .0001 ) at the forearm ; Transient Placebo TENS and No Current Placebo TENS groups at the h and ( P = .001 ) . There was no significant difference between Strong Non Painful TENS and Sensory Threshold TENS groups . The area under the curve for the changes in PPT significantly correlated with the current amplitude ( r(2 ) = .33 , P = .003 ) . These data therefore show that there is a dose-response effect of TENS with the largest effect occurring with the highest current amplitudes . PERSPECTIVE This study shows a dose response for the intensity of TENS for pain relief with the strongest intensities showing the greatest effect ; thus , we suggest that TENS intensity should be titrated to achieve the strongest possible intensity to achieve maximum pain relief Summary Pain and fatigue during movement , but not at rest , are reduced by a onetime 30‐m treatment with active transcutaneous electrical nerve stimulation ( TENS ) in individuals with fibromyalgia . Abstract Because transcutaneous electrical nerve stimulation ( TENS ) works by reducing central excitability and activating central inhibition pathways , we tested the hypothesis that TENS would reduce pain and fatigue and improve function and hyperalgesia in people with fibromyalgia who have enhanced central excitability and reduced inhibition . The current study used a double‐blinded r and omized , placebo‐controlled cross‐over design to test the effects of a single treatment of TENS with people with fibromyalgia . Three treatments were assessed in r and om order : active TENS , placebo TENS and no TENS . The following measures were assessed before and after each TENS treatment : pain and fatigue at rest and in movement ; pressure pain thresholds , 6‐m walk test , range of motion ; 5‐time sit‐to‐st and test , and single‐leg stance . Conditioned pain modulation was completed at the end of testing . There was a significant decrease in pain and fatigue with movement for active TENS compared to placebo and no TENS . Pressure pain thresholds increased at the site of TENS ( spine ) and outside the site of TENS ( leg ) when compared to placebo TENS or no TENS . During active TENS , conditioned pain modulation was significantly stronger compared to placebo TENS and no TENS . No changes in functional tasks were observed with TENS . Thus , the current study suggests TENS has short‐term efficacy in relieving symptoms of fibromyalgia while the stimulator is active . Future clinical trials should examine the effects of repeated daily delivery of TENS , similar to the way in which TENS is used clinical ly on pain , fatigue , function , and quality of life in individuals with fibromyalgia Objective . Pain is a patient-important outcome , but current reporting in r and omized controlled trials and systematic review s is often suboptimal , impeding clinical interpretation and decision making . Methods . A working group at the 2014 Outcome Measures in Rheumatology ( OMERACT 12 ) was convened to provide guidance for reporting treatment effects regarding pain for individual studies and systematic review s. Results For individual trials , authors should report , in addition to mean change , the proportion of patients achieving 1 or more thresholds of improvement from baseline pain ( e.g. , ≥ 20 % , ≥ 30 % , ≥ 50 % ) , achievement of a desirable pain state ( e.g. , no worse than mild pain ) , and /or a combination of change and state . Effects on pain should be accompanied by other patient-important outcomes to facilitate interpretation . When pooling data for meta analysis , authors should consider converting all continuous measures for pain to a 100 mm visual analog scale ( VAS ) for pain and use the established , minimally important difference ( MID ) of 10 mm , and the conventionally used , appreciably important differences of 20 mm , 30 mm , and 50 mm , to facilitate interpretation . Effects ≤ 0.5 units suggest a small or very small effect . To further increase interpretability , the pooled estimate on the VAS should also be transformed to a binary outcome and expressed as a relative risk and risk difference . This transformation can be achieved by calculating the probability of experiencing a treatment effect greater than the MID and the thresholds for appreciably important differences in pain reduction in the control and intervention groups . Conclusion . Presentation of relative effects regarding pain will facilitate interpretation of treatment effects & NA ; This study evaluated the effects of varying frequency , intensity and stimulation site , of transcutaneous electrical nerve stimulation ( TENS ) in an experimental model of pain . In a double‐blind design 240 volunteers were r and omised to one of six experimental TENS groups , a sham TENS or control ( n=30 per group ; gender balanced ) . Two TENS frequencies ( 110 or 4 Hz ) and two intensities ( strong but comfortable or highest tolerable ) at a fixed pulse duration ( 200 & mgr;s ) were applied at three sites relative to the measurement site ( segmentally , extrasegmentally or a combination of these ) , for 30 min . Pressure pain thresholds ( PPT ) were measured using a pressure algometer , in the first dorsal interosseous muscle , every 10 min , during stimulation and for a further 30 min . The high frequency , high intensity segmental , and combined stimulation groups , showed rapid onset and significant hypoalgesic effects . This effect was sustained for 20 min post‐stimulation in the high frequency segmental group . All other TENS intervention groups showed hypoalgesic responses similar to the sham TENS group , and none of these groups reached a clinical ly significant hypoalgesic level . Conclusions : The role of TENS frequency , intensity and site are pivotal to achieving optimal hypoalgesic effects , during and after stimulation . Clinical applications of these parameter combinations require further investigations & NA ; Transcutaneous electrical nerve stimulation ( TENS ) is a frequently applied therapy in chronic pain although evidence for effectiveness is inconclusive . Several types of TENS , based on different combinations of frequency , pulse duration and intensity , exist . The precise mechanism of action and the relevance of combinations of stimulus parameters are still unclear . To compare the effectiveness of three types of TENS we conducted a r and omized , single blinded crossover trial . Patients received two times a 2‐week period of daily TENS treatment , separated by a washout period of 2 weeks . In total , 180 chronic pain patients were r and omized into three groups . In group 1 , high frequency , low intensity TENS ( HFT ) was compared with high frequency , high intensity TENS ( HIT ) . In groups 2 and 3 , HFT and HIT were compared with a control TENS ( COT ) . The order of applying the different modalities of TENS in each group was also r and omized . Primary outcome was the patient 's overall assessment of effectiveness and pain reduction ( VAS ) . No differences were found in patient 's assessment or pain reducing effect between the three groups , indicating no superiority of one type of TENS . In total , 56 % continued TENS after the 2‐week treatment period . At 6 months , 42 % of all patients still used TENS . We concluded that there were no differences in effectiveness for the three types of TENS used in this study . Because no placebo group was included , no definite conclusions on effectiveness of TENS in general in the treatment of chronic pain could be made UNLABELLED This study compared a new transient sham transcutaneous electrical nerve stimulation ( TENS ) that delivers current for 45 seconds to an inactive sham and active TENS to determine the degree of blinding and influence on pain reduction . Pressure-pain thresholds ( PPT ) , heat-pain thresholds ( HPT ) , and pain intensities to tonic heat and pressure were measured in 69 healthy adults before and after r and omization . Allocation investigators and subjects were asked to identify the treatment administered . The transient sham blinded investigators 100 % of the time and 40 % of subjects compared to the inactive sham that blinded investigators 0 % of the time and 21 % of subjects . Investigators and subjects were blinded only 7 % and 13 % of the time , respectively , with active TENS . Neither placebo treatment result ed in significant changes in PPT , HPT , or pain intensities . Subjects using higher active TENS amplitudes ( > or = 17 mAs ) had significantly higher PPTs and lower pain intensities to tonic pressure than subjects using lower amplitudes ( < 17 mAs ) . HPTs and pain intensities to tonic heat were not significantly changed . The transient TENS completely blinds investigators to treatment and does not reduce pain , thereby providing a true placebo treatment . PERSPECTIVE This article presents the benefits of a new transient sham TENS device for use in prospect i ve , r and omized , clinical trials . This device facilitates blinding of subjects and investigators to eliminate expectation bias and determine the true efficacy of TENS for use in clinical population Objective : To investigate the hypoalgesic effects of transcutaneous electrical nerve stimulation ( TENS ) upon low back pain ( LBP ) in people with multiple sclerosis ( MS ) . Design : A r and omized double-blind placebo controlled clinical pilot study . Subjects and setting : Fifteen people with MS were recruited and r and omly allocated to one of the following groups under double blind conditions ( n = 5 per group ) : TENS 1 ( 4 Hz , 200 µs ) , TENS 2 ( 110 Hz , 200 µs ) , placebo TENS . Interventions : Treatment was applied for 45 minutes three times a week for six weeks with a four-week follow-up . Outcome measures : The following outcome measures were taken at weeks 1 , 6 , and 10 : visual analogue scale ( VAS ) ( for current LBP , right leg pain , left leg pain ) ; Leeds Multiple Sclerosis Quality of Life Question naire ; Rol and Morris Disability Question naire ; Short Form-36 ( SF-36 ) Version 1 ; and the McGill Pain Question naire ( MPQ ) . VAS for current LBP , right and left leg pain were also taken before and after treatment , and once a week during the follow-up period . Results : Analysis showed no statistically significant effects for any of the data . However , both active treatment groups showed a trend of improvement in the majority of the outcome measures . Conclusion : Active TENS was more effective than placebo TENS in decreasing VAS scores following each treatment although results were not statistically significant . Further work in this area is warranted and should include a larger number of participants in the form of a r and omized controlled clinical trial to determine the efficacy of this modality 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 OBJECTIVES A preliminary examination of NMES and combined NMES/TENS for the management of chronic back pain . DESIGN Double-blind , placebo-controlled , r and omized repeated measures . SUBJECTS AND SETTING Consecutive sample of 24 chronic back pain patients ( 16 women and 8 men ) attending an outpatient pain clinic ( mean age 51.67 years , mean pain duration 3.83 years ) . All treatments were administered at home . INTERVENTIONS Subjects self-
Output:
| We were therefore unable to conclude with any confidence that , in people with chronic pain , TENS is harmful , or beneficial for pain control , disability , health‐related quality of life , use of pain relieving medicines , or global impression of change . |
MS213246 | ***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: Reports of cluster r and omised trials require additional information to allow readers to interpret them accurately The effective reporting of r and omised controlled trials has received useful attention in recent years . Many journals now require that reports conform to the guidelines in the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement , first published in 1996 and revised in 2001 . The statement includes a checklist of items that should be included in the trial report . These items are evidence based whenever possible and are regularly review ed . The statement also recommends including a flow diagram to show the flow of participants from group assignment through to the final analysis . The CONSORT statement focused on reporting parallel group r and omised trials in which individual participants are r and omly assigned to study groups . However , in some situations it is preferable to r and omly assign groups of individuals ( such as families or medical practice s ) rather than individuals . Reasons include the threat of contamination of some interventions ( such as dietary interventions ) if individual r and omisation is used . 5 Also , in certain setting s r and omisation by group may be the only feasible method of conducting a trial . Trials with this design are variously known as field trials , community based trials , place based trials , or ( as in this paper ) cluster r and omised trials . In an earlier discussion paper we considered the implication s of the CONSORT statement for the reporting of cluster r and omised trials . Here we present up date d guidance , based on the 2001 revision of the CONSORT statement OBJECTIVE To evaluate the efficacy of a dementia care program to reduce behavior disorders in nursing home patients with dementia . DESIGN R and omized controlled clinical trial with 6-month follow-up . SETTING A 250-bed community nursing home . PATIENTS The nursing home was screened to identify patients with dementia and behavior disorders . A total of 118 patients were eligible for r and omization . Of these , 89 ( 75.4 % ) were r and omized , and 81 of these ( 91.0 % ) completed the trial . INTERVENTION The A.G.E. dementia care program consisted of Activities , Guidelines for psychotropic medications , and Educational rounds . The control treatment was usual nursing home care . MEASUREMENTS Behavior disorders , antipsychotic drug and physical restraint use , patient activity levels , and cognitive and functional status . RESULTS After 6 months , 12 of 42 ( 28.6 % ) intervention patients exhibited behavior disorders compared with 20 of 39 ( 51.3 % ) controls ( OR = 0.38 ; 95 % CI [ 0.15 , 0.95 ] ; P = .037 ) . Controls were more than twice as likely to receive antipsychotics ( OR = 2.55 , 95 % CI [ 0.96 , 6.76 ] ; P < .056 ) , to be restrained during activity times ( OR = 2.98 , 95 % CI [ 1.10 , 8.04 ] ; P < .028 ) , and to be restrained on nursing units ( OR = 2.14 , 95 % CI [ 0.9 , 5.3 ] ; P < .10 ) . Intervention patients were much more likely to participate in activities ( OR = 13.71 ; 95 % CI [ 4.51 , 41.73 ] ; P = .001 ) . CONCLUSIONS The A.G.E. program reduces the prevalence of behavior disorders and the use of antipsychotic drugs and restraints . It is practical , feasible , and appears to improve the lives of patients with dementia in nursing homes At present , observational studies and expert opinion are the best evidence for the use of physical restraints . Large regional and national disparities are described in acute and long-term care . Epidemiological data demonstrate a prevalence of 3 - 5 % body-fixed or near body restraint devices . The hip fracture rate in Germany are approximately 50 per 1000 resident years . Between 40 - 50 % of the residents in nursing homes are treated with psycho-tropic medication potentially limiting their physical mobility . The presented study protocol was design ed to test the effectiveness of a multifactorial intervention to reduce physical restraints in long-term care ( LTC ) residents particularly with cognitive impairment . The intervention consists of an educational and an organizational part to empower staff members to improve their skills and practice in using restraints . Technical devices to reduce fall related injuries are additionally offered to the LTC facilities . The study population includes 200 LTC residents in 54 facilities in three states in Germany . The sample size calculation was based upon a 5 % prevalence rate in the control group and an expected reduction of 50 % in the intervention group . The protocol is a waiting-list control design . All waiting facilities will be offered to participate after their waiting period . Primary endpoints are the number of restrained residents and resident time ( hours ) of being restrained . The use of psychotropics , falls , fall-related injuries and the incidence of residents newly being restrained is being monitored . The study starts with a baseline documentation of all facilities followed by r and omization and a three month intervention . Change agents will be responsible for the intervention . Technical devices will include a newly developed soft hip protector and sensor mats which notice the intent of leaving the bed . The aim of the study is to develop an evidence -based model for a knowledge transfer project to implement minimum restraint environments in LTC BACKGROUND This paper shows patients ' enactment of choice in mixed methods , multidisciplinary study on the use of bedrails as restraints . APPROACH Under the pressure of the implementation of impending legislation , patients from a Canadian elderly care rehabilitation unit were recruited to be part of this study and assigned to either a study or control group . Study group patients were exposed to a new facility policy on restraints in which bedrails were not to be used on a patient 's bed except under specified conditions . Patients in the control group continued to have bedrails on a routine basis according to the facility 's old policy . Following group assignments , patients could choose to crossover to either the control or study group based on their opinions about bedrails . FINDINGS After patients crossed over into either the study or control group , findings for the new groups differed significantly . Participants in the rails-up group had lower admission Functional Independence Measure scores ( p = .001 ) and higher admission Cumulative Illness Rating scores ( p = .000 ) compared to those in the rails-down group . CONCLUSIONS Patients have specific concerns related to the use of bedrails that might affect implementing bedrail minimization policies . Additionally , the authors conclude that patients ' input into research design may increase patients ' support of the protocol and help maintain study integrity 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 The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement was developed to improve the reporting of r and omised controlled trials . It was initially published in 1996 and focused on the reporting of parallel group r and omised controlled trials . The statement was revised in 2001 , with a further up date in 2010 . A separate CONSORT statement for the reporting of abstract s was published in 2008 . In earlier papers we considered the implication s of the 2001 version of the CONSORT statement for the reporting of cluster r and omised trial . In this paper we provide up date d and extended guidance , based on the 2010 version of the CONSORT statement and the 2008 CONSORT statement for the reporting of abstract s. Background Physical restraints are still frequently used in nursing home residents despite growing evidence for the ineffectiveness and negative consequences of these methods . Therefore , reduction in the use of physical restraints in psycho-geriatric nursing home residents is very important . The aim of this study was to investigate the short-term effects of an educational intervention on the use of physical restraints in psycho-geriatric nursing home residents . Methods A cluster r and omized trial was applied to 5 psycho-geriatric nursing home wards ( n = 167 residents with dementia ) . The wards were assigned at r and om to either educational intervention ( 3 wards ) or control status ( 2 wards ) . The restraint status was observed and residents ' characteristics , such as cognitive status , were determined by using the Minimum Data Set ( MDS ) at baseline and 1 month after intervention . Results Restraint use did not change significantly over time in the experimental group ( 55%–56 % ) , compared to a significant increased use ( P < 0.05 ) in the control group ( 56%–70 % ) . The mean restraint intensity and mean multiple restraint use in residents increased in the control group but no changes were shown in the experimental group . Logistic regression analysis showed that residents in the control group were more likely to experience increased restraint use than residents in the experimental group . Conclusion An educational programme for nurses combined with consultation with a nurse specialist did not decrease the use of physical restraints in psycho-geriatric nursing home residents in the short term . However , the residents in the control group experienced more restraint use during the study period compared to the residents in the experimental group . Whether the intervention will reduce restraint use in the long term could not be inferred from these results . Further research is necessary to gain insight into the long-term effects of this educational intervention OBJECTIVES To investigate the effects of an educational intervention on the use of physical restraints with psychogeriatric nursing home residents . DESIGN Cluster-r and omized trial . SETTING Fifteen psychogeriatric nursing home wards in the Netherl and s. PARTICIPANTS In total , 432 psychogeriatric nursing home residents from 15 psychogeriatric nursing home wards in seven nursing homes were selected for participation ; 404 consented , and 371 of these were available at baseline . Two hundred forty-one from 14 wards had complete data and were included in the data analyses . INTERVENTION The nursing home wards were assigned at r and om to educational intervention or control status . The educational intervention consisted of an educational program for nursing staff combined with consultation with a nurse specialist ( registered nurse ( RN ) level ) . MEASUREMENTS Data were collected at baseline and 1 , 4 , and 8 months postintervention . At each measurement , the use of physical restraints was measured using observations of blinded , trained observers on four separate occasions over a 24-hour period . Other resident characteristics , such as cognitive status , were determined using the Minimum Data Set . RESULTS Logistic and linear regression analyses showed no treatment effect on restraint status , restraint intensity , or multiple restraint use in any of the three postintervention measurements . Furthermore , only small changes occurred in the types of restraints used with residents in the experimental group . CONCLUSION An educational program for nursing staff combined with consultation with a nurse specialist ( RN level ) had no effect on the use of physical restraints with psychogeriatric nursing home residents . In addition to restraint education and consultation , new measures to reduce the use of physical restraints with psychogeriatric nursing home residents should be developed Background Physical restraints are regularly applied in German nursing homes . Their frequency varies substantially between centres . Beneficial effects of physical restraints have not been proven , however , observational studies and case reports suggest various adverse effects . We developed an evidence -based guidance on this topic . The present study evaluates the clinical efficacy and safety of an intervention programme based on this guidance aim ed to reduce physical restraints and minimise centre variations . Methods / Design Cluster-r and omised controlled trial with nursing homes r and omised either to the intervention group or to the control group with st and ard information . The intervention comprises a structured information programme for nursing staff , information material s for legal guardians and residents ' relatives and a one-day training workshop for nominated nurses . A total of 36 nursing home clusters including approximately 3000 residents will be recruited . Each cluster has to fulfil the inclusion criteria of at least 20 % prevalence of physical restraints at baseline . The primary endpoint is the number of residents with at least one physical restraint at six months . Secondary outcome measures are the number of falls and fall-related fractures . Discussion If successful , the intervention should be implemented throughout Germany . In case the intervention does not succeed , a three-month pre-post- study with an optimised intervention programme within the control group will follow the r and omised trial . Trial registration IS RCT The prevention of injury associated with falls in older people is a public health target in many countries around the world . Although there is good evidence that interventions such as multifactorial fall prevention and individually prescribed exercise are effective in reducing falls , the effect on serious injury rates is unclear . Historically , trials have not been adequately powered to detect injury endpoints , and
Output:
| There is insufficient evidence supporting the effectiveness of educational interventions targeting nursing staff for preventing or reducing the use of physical restraints in geriatric long-term care |
MS213247 | ***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: CONTEXT Hypothetically , topiramate can improve drinking outcomes among alcohol-dependent individuals by reducing alcohol 's reinforcing effects through facilitation of gamma-aminobutyric acid function and inhibition of glutaminergic pathways in the corticomesolimbic system . OBJECTIVE To determine if topiramate is a safe and efficacious treatment for alcohol dependence . DESIGN , SETTING , AND PARTICIPANTS Double-blind , r and omized , placebo-controlled , 14-week trial of 371 men and women aged 18 to 65 years diagnosed with alcohol dependence , conducted between January 27 , 2004 , and August 4 , 2006 , at 17 US sites . INTERVENTIONS Up to 300 mg/d of topiramate ( n = 183 ) or placebo ( n = 188 ) , along with a weekly compliance enhancement intervention . MAIN OUTCOME MEASURES Primary efficacy variable was self-reported percentage of heavy drinking days . Secondary outcomes included other self-reported drinking measures ( percentage of days abstinent and drinks per drinking day ) along with the laboratory measure of alcohol consumption ( plasma gamma-glutamyltransferase ) . RESULTS Treating all dropouts as relapse to baseline , topiramate was more efficacious than placebo at reducing the percentage of heavy drinking days from baseline to week 14 ( mean difference , 8.44 % ; 95 % confidence interval , 3.07%-13.80 % ; P = .002 ) . Prespecified mixed-model analysis also showed that topiramate compared with placebo decreased the percentage of heavy drinking days ( mean difference , 16.19 % ; 95 % confidence interval , 10.79%-21.60 % ; P < .001 ) and all other drinking outcomes ( P < .001 for all comparisons ) . Adverse events that were more common with topiramate vs placebo , respectively , included paresthesia ( 50.8 % vs 10.6 % ) , taste perversion ( 23.0 % vs 4.8 % ) , anorexia ( 19.7 % vs 6.9 % ) , and difficulty with concentration ( 14.8 % vs 3.2 % ) . CONCLUSION Topiramate is a promising treatment for alcohol dependence . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00210925 BACKGROUND Initiation of a relapse prevention medication is crucial at the end of alcohol detoxification . This study aim ed to examine the efficacy and safety of topiramate for alcoholism in patients receiving a residential treatment program of alcohol detoxification and post-acute treatment . METHODS This was a 12-week , r and omized , double-blind , placebo-controlled trial of topiramate for alcoholism in patients receiving a residential treatment program . Individuals with DSM-IV alcohol dependence with minimal withdrawal were enrolled . Participants were r and omly assigned to receive either 100 - 300 mg/day of topiramate or placebo . Primary outcomes were given as percentages of heavy drinking days and time to first day of heavy drinking . Other drinking outcomes , craving , and health-related quality of life were evaluated . RESULTS A total of 106 participants were r and omized to receive topiramate ( n=53 ) or placebo ( n=53 ) . Twenty-eight participants of the topiramate group ( 52.8 % ) and 25 participants of the placebo group ( 47.2 % ) completed the study . Averaged over the trial period , there was no significant difference between groups on the mean percentages of heavy drinking days [ 1.96 ( -1.62 to 5.54 ) , p=.28 ] . Log rank survival analysis found no difference of time to first day of heavy drinking between topiramate and placebo groups ( 61.8 vs. 57.5 days , respectively ; χ(2)=0.61 , d.f.=1 , p=.81 ) . Other secondary outcomes were not significantly different between groups . CONCLUSIONS By using a conservative model for data analysis , we could not detect the effectiveness of topiramate in this particular population . As the sensitivity analysis showed a trend of its benefit , further studies in larger sample sizes are still warranted BACKGROUND Topiramate , a sulphamate fructopyranose derivative , might antagonise alcohol 's rewarding effects associated with abuse liability by inhibiting mesocorticolimbic dopamine release via the contemporaneous facilitation of gamma-amino-butyric acid activity and inhibition of glutamate function . We aim ed to see whether topiramate was more effective than placebo as a treatment for alcohol dependence . METHODS We did a double-blind r and omised controlled 12-week clinical trial comparing oral topiramate and placebo for treatment of 150 individuals with alcohol dependence . Of these 150 individuals , 75 were assigned to receive topiramate ( escalating dose of 25 - 300 mg per day ) and 75 had placebo as an adjunct to weekly st and ardised medication compliance management . Primary efficacy variables were : self-reported drinking ( drinks per day , drinks per drinking day , percentage of heavy drinking days , percentage of days abstinent ) and plasma gamma-glutamyl transferase , an objective index of alcohol consumption . The secondary efficacy variable was self-reported craving . FINDINGS At study end , participants on topiramate , compared with those on placebo , had 2.88 ( 95 % CI -4.50 to -1.27 ) fewer drinks per day ( p=0.0006 ) , 3.10 ( -4.88 to -1.31 ) fewer drinks per drinking day ( p=0.0009 ) , 27.6 % fewer heavy drinking days ( p=0.0003 ) , 26.2 % more days abstinent ( p=0.0003 ) , and a log plasma gamma-glutamyl transferase ratio of 0.07 ( -0.11 to -0.02 ) less ( p=0.0046 ) . Topiramate-induced differences in craving were also significantly greater than those of placebo , of similar magnitude to the self-reported drinking changes , and highly correlated with them . INTERPRETATION Topiramate ( up to 300 mg per day ) is more efficacious than placebo as an adjunct to st and ardised medication compliance management in treatment of alcohol dependence CONTEXT The Consoli date d St and ards for Reporting of Trials ( CONSORT ) statement was developed to help improve the quality of reports of r and omized controlled trials ( RCTs ) . To date , a paucity of data exists regarding whether it has achieved this goal . OBJECTIVE To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs . DESIGN AND SETTING Comparative before- and -after evaluation in which reports of RCTs published in 1994 ( pre-CONSORT ) were compared with RCT reports from the same journals published in 1998 ( post-CONSORT ) . We included 211 reports from BMJ , JAMA , and The Lancet ( journals that adopted CONSORT ) as well as The New Engl and Journal of Medicine ( a journal that did not adopt CONSORT and was used as a comparator ) . MAIN OUTCOME MEASURES Number of CONSORT items included in a report , frequency of unclear reporting of allocation concealment , and overall trial quality score based on the Jadad scale , a 5-point quality assessment instrument . RESULTS Compared with 1994 , the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998 , and this increase was statistically significant for the 3 adopter journals ( pre-CONSORT , 23.4 ; mean change , 3.7 ; 95 % confidence interval [ CI ] , 2.1 - 5.3 ) . The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals , and this change was statistically significant for adopters ( pre-CONSORT , 61 % ; mean change , -22 % ; 95 % CI , -38 % to -6 % ) . Similarly , 3 of the 4 journals showed an improvement in the quality score for reports of RCTs , and this increase was statistically significant for adopter journals overall ( pre-CONSORT , 2.7 ; mean change , 0.4 ; 95 % CI , 0.1 - 0.8 ) . CONCLUSION Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs BACKGROUND More than half of all individuals with bipolar disorder have a substance abuse problem at some point in their lifetime . Patients with comorbid substance abuse disorders often are excluded from clinical trials . Thus , treatments targeting this high-risk clinical population are lacking . OBJECTIVE To evaluate the efficacy of divalproex sodium ( hereafter referred to as valproate ) in decreasing alcohol use and stabilizing mood symptoms in acutely ill patients with bipolar disorder and alcoholism . DESIGN A 24-week , double-blind , placebo-controlled , r and omized parallel-group trial . SETTING A university hospital serving as a primary catchment-area hospital and tertiary-care facility . PARTICIPANTS Fifty-nine subjects with diagnoses of bipolar I disorder and alcohol dependence . Intervention All study subjects received treatment as usual , including lithium carbonate and psychosocial interventions , and were r and omized to receive valproate or placebo . MAIN OUTCOME MEASURES Primary alcohol use outcomes included changes in alcohol use as indicated by changes in proportion of heavy drinking days and number of drinks per heavy drinking day . Other alcohol use outcomes included proportion of any drinking days , number of drinks per drinking day , and relapse to sustained heavy drinking . Mood outcomes included changes in depressive and manic symptoms . We used the mixed model to analyze longitudinal data . The first model used time of assessment , bipolar subtype ( mixed , manic , or depressed ) , and treatment group ( placebo or valproate ) as covariates . The second nested model included the additional covariate of medication adherence . RESULTS The valproate group had a significantly lower proportion of heavy drinking days ( P = .02 ) and a trend toward fewer drinks per heavy drinking day ( P = .055 ) than the placebo group . When medication adherence was added as covariate , the valproate group had significantly fewer drinks per heavy drinking day ( P = .02 ) and fewer drinks per drinking day ( P = .02 ) . Higher valproate serum concentration significantly correlated with improved alcohol use outcomes . Manic and depressive symptoms improved equally in both groups . Level of gamma-glutamyl transpeptidase was significantly higher in the placebo group compared with the valproate group . CONCLUSIONS Valproate therapy decreases heavy drinking in patients with comorbid bipolar disorder and alcohol dependence . The results of this study indicate the potential clinical utility of the anticonvulsant mood stabilizer , valproate , in bipolar disorder with co-occurring alcohol dependence Although drinking urges and cravings are commonly reported by alcoholics , prospect i ve studies have found inconsistent associations between such urges and drinking relapses . Previous studies have measured drinking urges by use of single-item ratings of alcohol craving or other measures of unknown reliability and validity . To permit improved evaluation of hypotheses regarding alcohol craving , a 49-item question naire that reflects several urge-related domains was developed and pretested . Items assessed subjects ' desire for a drink , expectations of positive effects following drinking , relief of withdrawal and negative affect following drinking , and intention to drink . Exploratory and confirmatory factor analyses of the responses of 351 abstinent , treatment-seeking alcoholics indicated that alcohol urges are best described by a single factor . Based on these analyses , an internally consistent , reliable , and psychometrically valid 8-item scale , the Alcohol Urge Question naire ( AUQ ) , was developed . Data indicated that AUQ scores were strongly related to alcohol dependence severity and to cognitive preoccupation with alcohol , and that they declined with prolonged abstinence . The AUQ may be useful in alcoholism treatment research and in laboratory studies of reactivity to alcohol or other manipulations Pregabalin ( PRE ) acts as a presynaptic inhibitor of the release of excessive levels of excitatory neurotransmitters by selectively binding to the α2-δ subunit of voltage-gated calcium channels . In this r and omised , double-blind comparison trial with naltrexone ( NAL ) , we aim ed to investigate the efficacy of PRE on alcohol drinking indices . Craving reduction and improvement of psychiatric symptoms were the secondary endpoints . Seventy-one alcohol-dependent subjects were detoxified and subsequently r and omised into two groups , receiving 50 mg of NAL or 150—450 mg of PRE . Craving ( VAS ; OCDS ) , withdrawal ( CIWA-Ar ) and psychiatric symptoms ( SCL-90-R ) rating scales were applied . Alcohol drinking indices and craving scores were not significantly different between groups . Compared with NAL , PRE result ed in greater improvement of specific symptoms in the areas of anxiety , hostility and psychoticism , and survival function ( duration of abstinence from alcohol ) . PRE also result ed in better outcome in patients reporting a comorbid psychiatric disorder . Results from this study globally place PRE within the same range of efficacy as that of NAL . The mechanism involved in the efficacy of PRE in relapse prevention could be less related to alcohol craving and more associated with the treatment of the comorbid psychiatric symptomat
Output:
| The direction of results was confirmed by subgroup analyses for topiramate and partially for gabapentin and valproate . |
MS213248 | ***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 National Institutes of Health 's consensus conference ( 1 ) defined osteoporosis as a skeletal disorder characterized by compromised bone strength predisposing to an increased risk for fracture . Bone strength reflects the integration of two main features : bone density and bone quality .Bone quality refers to architecture , turnover , damage accumulation ( e.g. , microfractures ) , and mineralization . Although osteoporosis can affect any bone , the hip , spine , and wrist are most likely to be affected . Osteoporosis affects an estimated 44 million Americans or 55 % of people 50 years of age or older . Another 34 million Americans are estimated to have low bone mass , meaning that they are at an increased risk for osteoporosis . Osteoporosis can be diagnosed by the occurrence of fragility fracture . In patients without fragility fracture , osteoporosis is often diagnosed by low bone density . Dual x-ray absorptiometry ( DXA ) is the current gold st and ard test for diagnosing osteoporosis in people without an osteoporotic fracture . Dual x-ray absorptiometry results are scored as st and ard deviations ( SDs ) from a young healthy norm ( usually female ) and reported as T-scores . For example , a T-score of 2 indicates a bone mineral density that is 2 SDs below the comparative norm . The international reference st and ard for the description of osteoporosis in postmenopausal women and in men age 50 years or older is a femoral neck bone mineral density of 2.5 SD or more below the young female adult mean ( 2 ) . Low bone density , as measured by DXA , is an imperfect predictor of fracture risk , identifying fewer than half the people who go on to have an osteoporotic fracture . Screening guidelines for women are well established ( 3 ) , and the American College of Physicians ( ACP ) recently published guidelines on screening for men ( 4 ) . This guideline presents the available evidence on various pharmacologic treatments to prevent fractures in men and women with low bone density or osteoporosis . Medications used to treat osteoporosis may affect different parts of the skeletal system differently , and efficacy for vertebral fractures does not necessarily imply efficacy for nonvertebral fractures . The target audience for this guideline is all clinicians and the target patient population is all adult men and women with low bone density or osteoporosis . These recommendations are based on the systematic evidence review by MacLean and colleagues ( 5 ) and the Agency for Healthcare Research and Quality sponsored Southern California Evidence -Based Practice Center evidence report ( 6 ) . The drugs currently approved for prevention of osteoporosis include alendronate , ib and ronate , risedronate , zoledronic acid , estrogen , and raloxifene . The drugs currently approved for treatment of osteoporosis include alendronate , ib and ronate , risedronate , calcitonin , teriparatide , zoledronic acid ( in postmenopausal women ) , and raloxifene . Testosterone , pamidronate , and etidronate are not approved by the U.S. Food and Drug Administration for the treatment or prevention of osteoporosis . Methods The literature search done by MacLean and colleagues for the systematic review ( 5 ) included studies from MEDLINE ( 1966 to December 2006 ) , the ACP Journal Club data base , the Cochrane Central Register of Controlled Trials ( no date limits ) , the Cochrane Data base of Systematic Review s ( no date limits ) , Web sites of the United Kingdom National Institute of Health and Clinical Excellence ( no date limits ) , and the United Kingdom Health Technology Assessment Program ( January 1998 to December 2006 ) . The review ers limited their search to English- language publications and human studies . They derived evidence for comparative benefits of various treatments exclusively from r and omized , controlled trials , whereas they included evidence from other types of studies for short- and long-term harms . Two physicians independently abstract ed data about study population s , interventions , follow-up , and outcome ascertainment by using a structured form . For each group within a r and omized trial , a statistician extracted the sample size and number of persons reporting fractures . Two review ers , under the supervision of the statistician , independently abstract ed information about adverse events . The statistician or the principal investigator resolved disagreements . This guideline is based on an evaluation of 76 r and omized , controlled trials , 4 of which were identified in the up date d search , and 24 meta-analyses that were included in the efficacy analyses . The analyses of adverse events included 491 articles , representing 417 r and omized trials , 25 other controlled clinical trials , 11 open-label trials , 31 large observational studies , and 9 case reports of osteonecrosis among bisphosphonate users . MacLean and colleagues ' background article ( 5 ) includes details about the methods used for the systematic evidence review . The ACP rates the evidence and recommendations by using the Grading of Recommendations , Assessment , Development , and Evaluation ( GRADE ) system with minor modifications ( Table 1 ) . In addition , the evidence review ers used predefined criteria to assess the quality of systematic review s and r and omized trials , based on internal and external validity assessment s detailed in the Quality of Reporting of Meta-Analyses ( QUOROM ) statement ( 7 ) . Table 1 . The American College of Physicians ' Guideline Grading System The objective of this guideline is to synthesize the evidence for the following questions : What are the comparative benefits in fracture reduction among and also within the following treatments for low bone density : bisphosphonates , specifically alendronate , risedronate , etidronate , ib and ronate , pamidronate , and zoledronic acid ; calcitonin ; estrogen for women ; teriparatide ; selective estrogen receptor modulators ( SERMs ) , specifically raloxifene and tamoxifen ; testosterone for men ; vitamins and minerals , specifically vitamin D and calcium ; and the combination of calcium plus vitamin D ? How does fracture reduction result ing from treatments vary among individuals with different risks for fracture as determined by bone mineral density ( borderline , low , or severe ) , previous fractures ( prevention vs. treatment ) , age , sex , glucocorticoid use , and other factors ( such as community-dwelling vs. institutionalized or vitamin Ddeficient vs. not ) ? What are the short- and long-term harms ( adverse effects ) of these therapies , and do these vary by specific sub population s ? Comparative Benefits of Drugs versus Placebo in Fracture Reduction Evidence from 24 meta-analyses ( 830 ) and 35 additional r and omized trials published after the meta-analyses ( 3165 ) described the effect of 9 of the 14 agents ( alendronate , etidronate , risedronate , calcitonin , estrogen , teriparatide , raloxifene , calcium , and vitamin D ) on fracture incidence . For 4 agents ( ib and ronate , pamidronate , zoledronic acid , and tamoxifen ) , the review ers found no meta-analyses and instead gathered the evidence from 14 r and omized trials ( 6679 ) . No studies were found that reported fracture rates for testosterone . Three r and omized trials ( 35 , 80 , 81 ) and 1 meta- analysis ( 82 ) evaluated the combination of calcium plus vitamin D on fractures . Bisphosphonates Good- quality evidence showed that alendronate , etidronate , ib and ronate , and risedronate prevent vertebral fractures . In addition , evidence from good- quality studies demonstrated that both alendronate and risedronate prevent nonvertebral and hip fractures . Two large r and omized trials showed that zoledronic acid prevents vertebral and nonvertebral fractures in high-risk population s and reduces the risk for hip fracture ( 67 , 74 ) . Ib and ronate has not been shown to reduce nonvertebral fractures ( 68 ) . Of the 6 fairly small trials that looked at vertebral fractures , 1 demonstrated a statistically significant reduction in fractures with pamidronate relative to placebo ( 0.14 [ 95 % CI , 0.03 to 0.72 ] ) ( 73 ) . However , after these data were pooled , the pooled risk estimate for fractures for pamidronate relative to placebo was not significant ( 0.52 [ CI , 0.21 to 1.24 ] ) ( 6 ) . Calcitonin Fair- quality evidence shows that calcitonin reduces vertebral fractures ( 83 , 84 ) . Good- quality evidence indicates that calcitonin does not reduce nonvertebral fractures ( 13 , 16 ) . Estrogen Good- quality evidence shows that estrogen reduces the incidence of vertebral ( 29 , 85 ) , nonvertebral ( 86 ) , and hip fractures ( 85 ) . Teriparatide Good- quality evidence shows that teriparatide prevents vertebral fractures . The evidence related to teriparatide preventing nonvertebral fractures is mixed ; 1 large r and omized trial showed a reduction in nonvertebral fractures ( 34 ) but 2 small trials did not ( 87 , 88 ) . SERMs Good- quality evidence shows that raloxifene prevents vertebral fractures , but that tamoxifen has no effect on vertebral fractures ( 8991 ) . In addition , both raloxifene and tamoxifen had no effect on hip fractures ( 91 ) . Tamoxifen is not approved by the U.S. Food and Drug Administration for the treatment or prevention of osteoporosis . Testosterone No studies reported fracture rates for testosterone . Calcium and Vitamin D In the studies evaluated by MacLean and colleagues ( 5 ) , the evidence for the effect of calcium alone on reduction of fractures is complex . Most studies of pharmacologic agents for osteoporosis include calcium and vitamin D as part of the treatment regimen . Evidence from 1 meta- analysis ( 27 ) and several r and omized trials ( 35 , 48 , 51 , 92 ) showed no significant difference between calcium and placebo in preventing vertebral , nonvertebral , and hip fractures in postmenopausal women . However , nonadherence to therapy may influence this result , and 1 trial with a prespecified analysis of adherent patients found a reduction in fracture risk ( 48 ) . A recent meta- analysis ( 82 ) concluded that the relative risk ( RR ) for fracture with calcium alone was 0.90 ( CI , 0.80 to 1.00 ) , but it did not include a modestly large trial with negative results ( 35 ) . MacLean and colleagues ( 5 ) Objective To evaluate the performance of the QFractureScores for predicting the 10 year risk of osteoporotic and hip fractures in an independent UK cohort of patients from general practice records . Design Prospect i ve cohort study . Setting 364 UK general practice s contributing to The Health Improvement Network ( THIN ) data base . Participants 2.2 million adults registered with a general practice between 27 June 1994 and 30 June 2008 , aged 30 - 85 ( 13 million person years ) , with 25 208 osteoporotic fractures and 12 188 hip fractures . Main outcome measures First ( incident ) diagnosis of osteoporotic fracture ( vertebra , distal radius , or hip ) and incident hip fracture recorded in general practice records . Results Results from this independent and external validation of QFractureScores indicated good performance data for both osteoporotic and hip fracture end points . Discrimination and calibration statistics were comparable to those reported in the internal validation of QFractureScores . The hip fracture score had better performance data for both women and men . It explained 63 % of the variation in women and 60 % of the variation in men , with areas under the receiver operating characteristic curve of 0.89 and 0.86 , respectively . The risk score for osteoporotic fracture explained 49 % of the variation in women and 38 % of the variation in men , with corresponding areas under the receiver operating characteristic curve of 0.82 and 0.74 . QFractureScores were well calibrated , with predicted risks closely matching those across all 10ths of risk and for all age groups . Conclusion QFractureScores are useful tools for predicting the 10 year risk of osteoporotic and hip fractures in patients in the United Kingdom Summary Using FRAX ® , this study aim ed at estimating 10-years probability of osteoporosis (OP)-related fractures and identifies those in need of OP treatment among primary care attendees in Saudi Arabia . Of those aged ≥ 60 years , 14.4 and 18.4 % scored probabilities for major and hip fractures respectively suggesting OP treatment . Predictors for receiving OP screening included the presence of multiple clinical risk factors , occurrence of fragility fractures and physicians recommendation . Purpose This study aim ed at estimating the 10-years probability of osteoporosis (OP)-related fractures and identifying those in need of OP treatment among Saudi adults attending primary care centers ( PHCs ) in Al Hassa , Saudi Arabia , using FRAX ® calculator and to determine factors possibly influence receiving of OP screening among them . Subjects and Methods A total of 1,251 Saudi aged ≥ 40 years , of both genders , were recruited from four urban and three rural r and omly selected PHCs . All were subjected
Output:
| Under current NOGG guidelines , based on age-dependent probability thresholds , inequalities in access to therapy arise especially at older ages ( ≥70 years ) depending on the presence or absence of a prior fracture .
An alternative threshold using a hybrid model reduces this disparity .
Conclusion The use of FRAX ( fixed or age-dependent thresholds ) as the gateway to assessment identifies individuals at high risk more effectively than the use of BMD . |
MS213249 | ***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 efficacy and tolerability of paroxetine ( a selective serotonin reuptake inhibitor ) with that of amitriptyline ( a tricyclic antidepressant ) in the treatment of depression in 191 patients with rheumatoid arthritis ( RA ) . METHODS A r and omized , double blind , double dummy , parallel group study . A placebo washout period of 3 - 7 days was followed by an 8 week active treatment phase during which patients received either paroxetine ( 20 - 40 mg daily ) or amitriptyline ( 75 - 150 mg daily ) . The primary efficacy variable was the change from baseline in Montgomery Asberg Depression Rating Scale score at endpoint . RESULTS Paroxetine was as effective as amitriptyline for the treatment of depression , with similar improvements in RA associated pain and disability also seen in both groups . However , paroxetine was better tolerated than amitriptyline , with an overall frequency of adverse experiences of 56.4 % and 67.7 % in the 2 groups , respectively . The frequency of anticholinergic adverse experiences was much lower in the paroxetine treatment group ( 18.1 % vs 43.8 % taking amitriptyline ) and paroxetine treated patients also experienced fewer severe ( 16.0 % vs 21.9 % ) , serious nonfatal ( 0 % vs 4.2 % ) , and drug related adverse experiences ( 12.8 % vs 29.2 % ) . CONCLUSION Tolerability is an important consideration in this patient population , which is largely composed of elderly patients who are taking additional medications for RA . Paroxetine shows a number of advantages in the management of depression comorbid with RA Thirty-six patients with definite or classical rheumatoid arthritis participated in a double-blind , r and omized , placebo-controlled trial to assess the effectiveness of adding amitriptyline to the treatment regimen for the relief of pain not adequately controlled by non-steroidal anti-inflammatory drugs . Dosage of amitriptyline was increased gradually up to 25 mg 3-times daily and patients were followed up for 12 weeks . Assessment s were made of joint pain and tenderness every 4 weeks . The results showed no difference between the amitriptyline and placebo-treated patients for either parameter The effectiveness of dothiepin ( a tricyclic anti-depressant ) at a dose of 75 mg given orally at night was compared with placebo for 4 weeks in alleviating pain in 60 patients with classical or definite active rheumatoid arthritis . Patients were classified as either ‘ depressed ’ or ‘ not depressed ’ . The week before , during and 2 weeks after the study , 600 mg ibuprofen was given orally three times daily to all patients . Compared with placebo , dothiepin produced a significant reduction in daytime pain by the end of the treatment period . The Hamilton rating scale in ‘ depressed ’ patients was significantly improved in patients given dothiepin . The Cassano – Castrogiovanni self-evaluation rating scale in both ‘ depressed ’ and ‘ not depressed ’ patients showed a tendency ( not significant ) to be improved following dothiepin treatment compared with placebo . These results suggest that patients with rheumatoid arthritis may experience an increase in pain symptoms due to an alteration of mood . Therapy with tricyclic anti-depressants , such as dothiepin , therefore , may determine an improvement of pain indexes besides having an anti-depressant effect We report an open-label trial of sertraline in the treatment of major depression in 54 consecutive rheumatoid arthritis ( RA ) patients meeting DSM-IV criteria for major depressive disorder . We initially surveyed 628 RA out patients with the Center for Epidemiologic Studies Depression Scale ( CES-D ) and invited those with depression to be evaluated further and treated . Eighty-four RA patients reporting depressive symptoms agreed to participate in person , and 56 met the criteria for major depressive disorder . Of these 56 patients , 54 agreed to medication treatment and were enrolled in the study . Patients were also r and omized to one of three psychological treatment conditions , but for this study , conditions were collapsed because previous research on this sample indicated no significant between-group differences in depression after treatment . Patients were assessed with the CES-D and the Hamilton Rating Scale for Depression after the intervention , at 6-month follow-up , and at 15-month follow-up . At the last follow-up , 41 patients remained for assessment . In this study , sertraline was found to be a safe and efficacious treatment of depression complicating RA Actions on performance of dextropropoxyphene ( DXP ) alone and in combination with amitriptyline ( AMI ) , indomethacin ( IN ) , and placebo were compared in 15 patients with rheumatoid arthritis . The patients were on their prescribed maintenance regimen excluding analgesics . In four r and omized test sessions at two-week intervals , they received double blind and crossover single oral doses of DXP 130 mg , IN 50 mg , DXP 65 mg + AMI 25 mg or placebo , each after two days ' pretreatment with the same drug . Objective and subjective effects were measured at baseline and 2 and 4 hours after drug administration . DXP impaired critical flicker discrimination , symbol copying and body balance without modifying tracking , choice reactions or attention . It rendered the subjects elated , muzzy , mentally slow and calm . Actions of AMI + DXP were about the same . IN impaired body balance and critical flicker recognition . Plasma concentrations of DXP were moderate to high whilst those of IN and AMI were fairly low . We conclude that therapeutic doses of DXP and IN are relatively safe in regard to driving skills . Small doses of AMI may not enhance the mild psychomotor effects of DXP . Earlier single dose studies carried out with healthy volunteers might have overestimated the decremental effects of analgesics on psychomotor performance OBJECTIVE To examine the effectiveness of cognitive-behavioral and pharmacologic treatment of depression in rheumatoid arthritis ( RA ) . METHODS Subjects ( n = 54 ) with confirmed diagnoses of both major depression and RA were r and omly assigned to 1 of 3 groups : 1 ) cognitive-behavioral/pharmacologic group ( CB-PHARM ) , 2 ) attention-control/pharmacologic group , or 3 ) pharmacologic control group . Measures of depression , psychosocial status , health status , pain , and disease activity were collected at baseline , posttreatment ( 10 weeks ) , 6-month followup , and 15-month followup . Data were analyzed to compare the treatment effectiveness of the groups ; data also were aggregated to examine the effects of antidepressive medication over time . Lastly , a no-treatment control group was defined from a cohort of persons who declined participation . RESULTS Baseline comparisons on demographic and dependent measures revealed a need to assess covariates on age and education ; baseline scores on dependent measures also were entered as covariates . Analyses of covariance revealed no statistically significant group differences at postintervention , 6-month followup , or 15-month followup , except higher state and trait anxiety scores for the CB-PHARM group at the 15-month followup . In the longitudinal analyses of the effects of antidepressive medication , significant improvement in psychological status and health status were found at posttreatment , 6-month followup , and 15-month followup , but no significant improvements were shown for pain or disease activity . In addition , the comparison of the aggregated pharmacologic group with a no-treatment group revealed a statistically significant benefit for the 3 groups that received the antidepressive medication . CONCLUSION In persons with RA , cognitive-behavioral approaches to the management of depression were not found to be additive to antidepressant medication alone , but antidepressant intervention was superior to no treatment Summary A double-blind placebo-controlled trial was carried out in 20 patients with classical rheumatoid arthritis to study the effect of imipramine on rheumatoid factor titres . Patients were allocated at r and om to receive 6-weeks treatment with imipramine , in low dosage , or placebo in addition to their antirheumatic medication . They were then followed up for a further 4 weeks during which only their antirheumatic medication was continued . Assessment s were made , at entry and after 3,6 and 10 weeks , of rheumatoid factor titres , pain scores , articular index , PIP joint size , grip strength , erythrocyte sedimentation rate and depression index . The results showed that changes in rheumatoid factor titre in the placebo and post-treatment groups were similar to changes occurring during the administration of imipramine . There was , however , a significant correlation between the changes in depression rating score and articular index A r and omised , double‐blind , multiple dose , crossover study with three 3‐week treatment periods was set up to compare the analgesic efficacy and adverse effects of amitriptyline in oral doses of 25 , 50 or 75 mg . Patients used diaries to assess their pain , and clinic assessment s were made at the end of each treatment period . It was found that in 29 patients with chronic ( more than 2 months ) pain , amitriptyline 75 mg provided significantly greater efficacy than amitriptyline 25 or 50 mg . There was no significant difference in mood scores between the different doses of amitriptyline , but sleep was judged significantly better with 75 mg compared with 25 mg . The incidence of adverse effects was significantly higher with the 75 mg dose , and the principal adverse effects were dry mouth and drowsiness . In the context of chronic pain , the analgesic effect of amitriptyline was shown to have a dose‐response unrelated to mood elevation , but there was a dose‐response for the incidence of adverse effects The effect of low-dose trimipramine ( 25 to 75 mg/day ) on joint pain and tenderness in 36 patients with rheumatoid arthritis was studied in a r and omized double-blind trial carried out over a period of 12 weeks . The patients were pre-selected to include only patients who were depressed on a ' self-rating depression scale ' but had no evidence of fibrositic ' trigger-points ' . The results showed that joint pain and tenderness were significantly reduced with trimipramine , but depression scores remained unchanged & NA ; The aim of this study was to examine the impact of pain on quality of life and its components in a representative sample of 320 well people , and patients selected from all major categories of illness . Quality of life was assessed using a new , multidimensional , multilingual , generic profile design ed for cross‐cultural use in health care , i.e. the WHOQOL . Within the WHOQOL , pain and discomfort is one of 29 areas or facets of quality of life , grouped into six domains . It was found that pain and discomfort made a significant impact on perceptions of general quality of life related to health . Furthermore , the presence of pain affected perceptions of five of the six domains of quality of life ; the domain of spirituality , religion and personal beliefs being the exception . When quality of life is assessed , negative feelings are most closely associated with reports of pain and discomfort than any other facet . But quality of life surrounding pain and discomfort is more fully explained by the inclusion of six additional facets ; the availability of social care , mobility , activities of daily living , positive mood and to a lesser extent , sleep and dependence on medication . Together , these seven facets represent criteria against which the success of pain treatments may be evaluated . As predicted , those who were pain‐free had significantly better quality of life than those in pain . A longer duration of pain is associated with increasingly poorer quality of life . Intense affective pain is particularly detrimental to a good quality of life . The psychometric properties of the pain and discomfort facet of the WHOQOL and WHOQOL‐100 were assessed . Internal consistency ( reliability ) , discriminant and criterion/concurrent validity were found to be good to excellent , justifying the use of this instrument with a range of chronic and acute pain patients A long-term ( two years ) double-blind , comparative trial of diftalone ( Aladione ® ) 500 mg versus indomethacin 75 mg per day , in rheumatoid arthritis ( thirty-two patients ) , has shown a similar effectiveness for both anti-inflammatory agents on various clinical parameters of disease activity , some better results being obtained for diftalone as regards the capacity of reducing erythrocyte sedimentation rate . The tolerability of diftalone proved to be somewhat superior , as is shown by the lower number of patients complaining of side-effects or being dropped out for intolerance , and by the lower frequency of central nervous system disturbances In a r and omized , double-blind , parallel study , fluoxetine and amitriptyline were compared with placebo in the treatment of chronic rheumatic pain . A total of 59 patients were evaluated during 4 wk of treatment and received 20 mg fluoxetine , 25 mg amitriptyline , or placebo daily . Pain intensity , pain relief , vital variables , and global evaluation were used to assess efficacy . To evaluate safety variables , the incidence of side effects was noted . Both amitriptyline and fluoxetine significantly reduced pain intensity compared with placebo . Similarly , pain relief was greater with both amitriptyline and fluoxetine than with placebo . At the end of the fourth week , fluoxetine was superior in efficacy to amitriptyline . The incidence of adverse effects was significantly greater with amitriptyline ; dryness of the mouth was the most predominant side effect . We conclude that fluoxetine is an effective analgesic with
Output:
| The qualitative analyses found no evidence of an effect of antidepressants on pain intensity or depression in the short-term ( less than one week ) , and conflicting evidence of a medium- ( one to six weeks ) or long-term ( more than six weeks ) benefit .
The use of these agents may be associated with adverse events which are generally mild and do not lead to cessation of treatment . |
MS213250 | ***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 It is generally accepted that smoking increases blood pressure and inhibits muscle sympathetic nerve activity ( SNA ) . The decrease in muscle SNA with cigarette smoking might be secondary to baroreflex responses to the pressor effect of smoking , thus obscuring a sympathetic excitatory effect of smoking . We tested the hypothesis that smoking increases sympathetic outflow . METHODS AND RESULTS We examined the effects of sham smoking , cigarette smoking , and cigarette smoking in combination with nitroprusside on muscle ( baroreflex-dependent ) SNA in 10 healthy habitual smokers . The 3 sessions were performed in r and om order , each study on a separate day . In an additional study , we also investigated the effects of sham smoking and cigarette smoking on skin ( baroreflex-independent ) SNA in 9 subjects . Compared with sham smoking , cigarette smoking alone increased blood pressure and decreased muscle SNA . When the blood pressure increase in response to smoking was blunted by nitroprusside infusion , there was a striking increase in muscle SNA . Muscle SNA increased up to 3-fold the levels seen before smoking ( P<0.001 ) , accompanied by an increase in heart rate of up to 37+/-4 bpm . Cigarette smoking also induced a 102+/-22 % increase in skin SNA ( P=0.03 ) . CONCLUSIONS These data provide the first direct evidence that cigarette smoking increases sympathetic outflow Cigarette smoking is associated with impaired endothelium‐dependent dilatation in human veins and arteries . An in vivo study in animals suggests that nicotine may contribute to this abnormality . We tested the hypothesis that local administration of nicotine at a dose reproducing the plasma concentration observed during smoking would impair endothelium‐dependent vasodilatation in human veins in vivo Using a reliable , newly developed assay for ascorbic acid ( reduced form ) and dehydroascorbic acid ( DHAA ; the oxidized form ) in plasma , we studied the influence of age , sex , and smoking on 219 healthy , age-stratified , and r and omly selected subjects representing the Danish population . The mean ( + /-SD ) plasma total ascorbic acid ( ascorbic acid + DHAA ) concentration was lower in smokers ( 62.8 + /- 24.9 mumol/L ) than in nonsmokers ( 74.9 + /- 23.6 mumol/L ) ( P < 0.001 ) and the DHAA content was 1.8 + /- 4.0 % of the total ascorbic acid in smokers compared with 0.1 + /- 3.1 % in nonsmokers ( P < 0.001 ) . A significant inverse correlation between the DHAA fraction and the total ascorbic acid concentration was found in smokers ( P < 0.002 ) but not in smokers ; the slopes of the linear regressions were significantly different in the two groups ( P < 0.005 ) . The mean plasma concentration of total ascorbic acid was higher in females than in males ( P < 0.005 ) ; this difference persisted in multivariate analysis when smoking was adjusted for . No age dependence could be identified . The data show that smoking results in severe oxidative stress , depletion of the ascorbic acid pool , and insufficient reduction capacity to maintain ascorbic acid in the reduced form in plasma . We suggest that the additional analysis of DHAA allows further differentiation in the assessment of oxidative stress and may provide an objective way of determining vitamin C requirements in smokers . Preliminary findings suggest that a vitamin C dose that results in a plasma concentration of approximately 70 mumol/L or higher is required in smokers BACKGROUND An association between smoking and impaired wound healing has been reported in retrospective studies . The smoking status of a surgical patient may be confounded by social and medical parameters . We have evaluated the effect of smoking in a test wound in volunteers , with special reference to a reliable scientific match between smokers and nonsmokers . METHODS In a prospect i ve open study with blinded assessment , 19 smoking ( 20 cigarettes/day ) and 18 nonsmoking healthy volunteers were matched with respect to baseline characteristics . The deposition of total protein and mature collagen ( expressed as hydroxyproline ) was assessed in an exp and ed polytetrafluoroethylene wound healing model implanted subcutaneously for 10 days . RESULTS The nonsmokers had a 1.8 times higher median amount of hydroxyproline than the smokers ( p < 0.01 ) . The deposition of hydroxyproline was negatively correlated with the consumption of tobacco both before ( r = -0.44 ; p < 0.01 ) and during the study ( r = -0.48 ; p < 0.005 ) . The impairment was specific for the production of collagenous proteins and not other proteins . CONCLUSIONS The synthesis of subcutaneous collagen in smokers is specifically impeded , indicating an impaired wound-healing process . Because mature collagen is the main determinator of strength of an operative wound , the results support the view that patients should be advised to stop smoking before an operation Objective —The role of antioxidants in preventing vascular disease remains controversial . Vascular endothelial growth factor ( VEGF-A ) is important for endothelial and monocyte function . This study investigated the negative effects of smoking on monocyte migratory responsiveness to VEGF-A and the usefulness of vitamin C to prevent smoking-induced monocyte dysfunction . Methods and Results —The chemotactic response of isolated monocytes from a cohort of 17 non-smokers and 10 smokers toward VEGF-A was assessed . VEGF-A significantly stimulated the migration of monocytes in non-smokers ; the monocytes from smokers failed to respond to VEGF-A. Repeated analysis after 2 weeks of vitamin C intake ( 2g/d ) showed a fully restored VEGF-A – induced monocyte migration in smokers . VEGF-A serum levels were not altered by vitamin C. VEGF-A – inducible kinase activity was intact in monocytes from smokers as assessed by in vitro kinase assay . Monocyte dysfunction can be mimicked in vitro by challenging monocytes with a range of reactive oxygen species ( ROS ) . Conclusions —Stimulation of monocyte migration by VEGF-A was severely attenuated in smokers , and the deficit observed was surmounted by vitamin C supplementation . The negative effects of smoking on monocyte function may translate into adverse impacts on VEGF-A – dependent repair processes such as arteriogenesis . These results propose a causative role of oxidative stress in smoking-induced monocyte dysfunction Higher white blood cell counts in smokers compared with nonsmokers have been well documented , but the longitudinal relation between changes in smoking and changes in white blood cells has not been well described . Since 1984 , data have been collected semiannually by the Multicenter AIDS Cohort Study ( MACS ) , a four-center prospect i ve cohort study of acquired immunodeficiency syndrome ( AIDS ) in homosexual men . The study population includes 2,435 participants who were human immunodeficiency virus ( HIV ) seronegative as of September 1994 and who contributed 20,918 person-visits for this analysis . For individuals who modified their smoking behavior , changes in white blood cell counts occurred primarily during the first 6 months following changes in the amount of cigarettes smoked . Among former smokers who resumed smoking , the extent of the increase in white blood cell count depended on the number of cigarettes smoked . Specifically , increases of 241 , 340 , and 740 cells/microliter were observed for smokers who resumed smoking < 1 , 1 to < 2 , and > or = 2 packs/day , respectively . Conversely , smokers who quit smoking had a decrease of white blood cell count : -32 , -629 , and -1,122 cells/microliter for men who previously smoked < 1 , 1 to < 2 , and > or = 2 packs/day , respectively . Long-term ex-smokers , however , still had higher white blood cell counts than did never smokers . There was a high within-individual correlation of white blood cell count in persons who reported a consistent level of smoking ( i.e. , average correlations between two white blood cell counts 6 years apart were 0.51 for never smokers , 0.48 for ex-smokers , 0.56 for men who smoked < 1 pack/day , and 0.43 for men who smoked > or = 1 pack/day ) . These analyses indicate an acute effect of changes in smoking on changes in white blood cell count , a residual effect of having been a smoker , and high long-term tracking for white blood cell count BACKGROUND Smokers are at higher risk of cardiopulmonary and wound-related postoperative complications than non-smokers . Our aim was to investigate the effect of preoperative smoking intervention on the frequency of postoperative complications in patients undergoing hip and knee replacement . METHODS We did a r and omised trial in three hospitals in Denmark . 120 patients were r and omly assigned 6 - 8 weeks before scheduled surgery to either the control ( n=60 ) or smoking intervention ( 60 ) group . Smoking intervention was counselling and nicotine replacement therapy , and either smoking cessation or at least 50 % smoking reduction . An assessor , who was masked to the intervention , registered the occurrence of cardiopulmonary , renal , neurological , or surgical complications and duration of hospital admittance . The main analysis was by intention to treat . FINDINGS Eight controls and four patients from the intervention group were excluded from the final analysis because their operations were either postponed or cancelled . Thus , 52 and 56 patients , respectively , were analysed for outcome . The overall complication rate was 18 % in the smoking intervention group and 52 % in controls ( p=0.0003 ) . The most significant effects of intervention were seen for wound-related complications ( 5 % vs 31 % , p=0.001 ) , cardiovascular complications ( 0 % vs 10 % , p=0.08 ) , and secondary surgery ( 4 % vs 15 % , p=0.07 ) . The median length of stay was 11 days ( range 7 - 55 ) in the intervention group and 13 days ( 8 - 65 ) in the control group . INTERPRETATION An effective smoking intervention programme 6 - 8 weeks before surgery reduces postoperative morbidity , and we recommend , on the basis of our results , this programme be adopted Delayed wound healing may explain postoperative tissue and wound dehiscence in smokers , but the effects of smoking and smoking cessation on the cellular mechanisms remain unclear . Suction blisters were raised in 48 smokers and 30 never smokers . The fluid was retrieved and the epidermal roof was excised . Transepidermal water loss ( TEWL ) was measured after 2 , 4 , and 7 days . Then , the smokers were r and omized to continuous smoking or abstinence with a transdermal nicotine patch or a placebo by concealed allocation . The sequence was repeated after 4 , 8 , and 12 weeks in all smokers and abstainers and in 6 never smokers . Matrix metalloproteinase (MMP)-8 and MMP-1 levels in suction blister fluid were assessed by an enzyme-linked immunosorbent assay . R and om-effects models for repeated measurements were applied and p < or = 0.05 was considered significant . One week after wounding the TEWL was 17.20 ( 14.47 - 19.92 ) g/cm(2 ) hour ( mean , 95 % CI ) in smokers and 13.89 ( 9.46 - 18.33 ) in never smokers ( p<0.01 ) . In abstinent smokers TEWL was 18.95 (15.20 - 22.70)(p<0.01 , when compared with smokers ) . In smokers , MMP-8 was 36.4 ( 24.3 - 48.5 ) ng/mL ( mean , 95 % CI ) and 15.2 ( 1.4 - 30.2 ) ng/mL in never smokers ( p<0.01 ) . Abstinent smokers ' MMP-8 level was 21.2 ng/mL ( 6.6 - 43.0 ) ( p=0.02 , when compared with smokers ) . MMP-1 was unaffected by smoking and abstention . Transdermal nicotine patch did not affect any parameter . We conclude that smoking attenuates epidermal healing and may enhance extracellular matrix degradation . Three months of abstinence from smoking does not restore epidermal healing , whereas 4 weeks of abstinence normalizes suction blister MMP-8 levels . These findings suggest sustained impaired wound healing in smokers and potential reversibility of extracellular matrix degradation OBJECTIVES We sought to determine the effects of nicotine patch therapy , when used to promote smoking cessation , on myocardial ischemia in patients with coronary artery disease . BACKGROUND Nicotine patches substantially increase quit rates among cigarette smokers , but their safety in patients with myocardial ischemia who are attempting to quit smoking is unknown . METHODS This is a
Output:
| RESULTS Smoking decreases tissue oxygenation and aerobe metabolism temporarily .
The inflammatory healing response is attenuated by a reduced inflammatory cell chemotactic responsiveness , migratory function , and oxidative bactericidal mechanisms .
In addition , the release of proteolytic enzymes and inhibitors is imbalanced .
The proliferative response is impaired by a reduced fibroblast migration and proliferation in addition to a downregulated collagen synthesis and deposition .
Smoking cessation restores tissue oxygenation and metabolism rapidly .
Inflammatory cell response is reversed in part within 4 weeks , whereas the proliferative response remains impaired .
Nicotine does not affect tissue microenvironment , but appears to impair inflammation and stimulate proliferation .
CONCLUSIONS Smoking has a transient effect on the tissue microenvironment and a prolonged effect on inflammatory and reparative cell functions leading to delayed healing and complications .
Smoking cessation restores the tissue microenvironment rapidly and the inflammatory cellular functions within 4 weeks , but the proliferative response remain impaired .
Nicotine and nicotine replacement drugs seem to attenuate inflammation and enhance proliferation but the effect appears to be marginal |
MS213251 | ***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 likelihood of distant recurrence in patients with breast cancer who have no involved lymph nodes and estrogen-receptor-positive tumors is poorly defined by clinical and histopathological measures . METHODS We tested whether the results of a reverse-transcriptase-polymerase-chain-reaction ( RT-PCR ) assay of 21 prospect ively selected genes in paraffin-embedded tumor tissue would correlate with the likelihood of distant recurrence in patients with node-negative , tamoxifen-treated breast cancer who were enrolled in the National Surgical Adjuvant Breast and Bowel Project clinical trial B-14 . The levels of expression of 16 cancer-related genes and 5 reference genes were used in a prospect ively defined algorithm to calculate a recurrence score and to determine a risk group ( low , intermediate , or high ) for each patient . RESULTS Adequate RT-PCR profiles were obtained in 668 of 675 tumor blocks . The proportions of patients categorized as having a low , intermediate , or high risk by the RT-PCR assay were 51 , 22 , and 27 percent , respectively . The Kaplan-Meier estimates of the rates of distant recurrence at 10 years in the low-risk , intermediate-risk , and high-risk groups were 6.8 percent ( 95 percent confidence interval , 4.0 to 9.6 ) , 14.3 percent ( 95 percent confidence interval , 8.3 to 20.3 ) , and 30.5 percent ( 95 percent confidence interval , 23.6 to 37.4 ) . The rate in the low-risk group was significantly lower than that in the high-risk group ( P<0.001 ) . In a multivariate Cox model , the recurrence score provided significant predictive power that was independent of age and tumor size ( P<0.001 ) . The recurrence score was also predictive of overall survival ( P<0.001 ) and could be used as a continuous function to predict distant recurrence in individual patients . CONCLUSIONS The recurrence score has been vali date d as quantifying the likelihood of distant recurrence in tamoxifen-treated patients with node-negative , estrogen-receptor-positive breast cancer BACKGROUND PAM50 is a 50-gene test that is design ed to identify intrinsic breast cancer subtypes and generate a Risk of Recurrence ( ROR ) score . It has been developed to be carried out in qualified routine hospital pathology laboratories . PATIENTS AND METHODS One thous and four hundred seventy-eight postmenopausal women with estrogen receptor (ER)+ early breast cancer ( EBC ) treated with tamoxifen or tamoxifen followed by anastrozole from the prospect i ve r and omized ABCSG-8 trial were entered into this study . Patients did not receive adjuvant chemotherapy . RNA was extracted from paraffin blocks and analyzed using the PAM50 test . Both intrinsic subtype ( luminal A/B , HER2-enriched , basal-like ) and ROR score were calculated . The primary analysis was design ed to test whether the continuous ROR score adds prognostic value in predicting distant recurrence ( DR ) over and above st and ard clinical variables . RESULTS In all tested subgroups , ROR score significantly adds prognostic information to the clinical predictor ( P<0.0001 ) . PAM50 assigns an intrinsic subtype to all cases , and the luminal A cohort had a significantly lower ROR at 10 years compared with Luminal B ( P<0.0001 ) . Significant and clinical ly relevant discrimination between low- and high-risk groups occurred also within all tested subgroups . CONCLUSION ( S ) The results of the primary analysis , in combination with recently published results from the ATAC trial , constitute Level 1 evidence for clinical validity of the PAM50 test for predicting the risk of DR in postmenopausal women with ER+ EBC . A 10-year metastasis risk of < 3.5 % in the ROR low category makes it unlikely that additional chemotherapy would improve this outcome -this finding could help to avoid unwarranted overtreatment . CLINICAL TRIAL NUMBER ABCSG 8 : NCT00291759 Introduction Patients with early-stage breast cancer , treated with endocrine therapy , have approximately 90 % 5-year disease-free survival . However , for patients at higher risk of relapse despite endocrine therapy , additional adjuvant therapy , such as chemotherapy , may be indicated . The challenge is to prospect ively identify such patients . The Mammostrat ® test uses five immunohistochemical markers to stratify patients on tamoxifen therapy into risk groups to inform treatment decisions . We tested the efficacy of this panel in a mixed population of cases treated in a single center with breast-conserving surgery and long-term follow-up . Methods Tissue microarrays from a consecutive series ( 1981 to 1998 ) of 1,812 women managed by wide local excision and postoperative radiotherapy were collected following appropriate ethical review . Of 1,390 cases stained , 197 received no adjuvant hormonal or chemotherapy , 1,044 received tamoxifen only , and 149 received a combination of hormonal therapy and chemotherapy . Median age at diagnosis was 57 , 71 % were postmenopausal , 23.9 % were node-positive and median tumor size was 1.5 cm . Sample s were stained using triplicate 0.6 mm2 tissue microarray cores , and positivity for p53 , HTF9C , CEACAM5 , NDRG1 and SLC7A5 was assessed . Each case was assigned a Mammostrat ® risk score , and distant recurrence-free survival ( DRFS ) , relapse-free survival ( RFS ) and overall survival ( OS ) were analyzed by marker positivity and risk score . Results Increased Mammostrat ® scores were significantly associated with reduced DRFS , RFS and OS in estrogen receptor (ER)-positive breast cancer ( P < 0.00001 ) . In multivariate analyses the risk score was independent of conventional risk factors for DRFS , RFS and OS ( P < 0.05 ) . In node-negative , tamoxifen-treated patients , 10-year recurrence rates were 7.6 ± 1.5 % in the low-risk group versus 20.0 ± 4.4 % in the high-risk group . Further , exploratory analyses revealed associations with outcome in both ER-negative and untreated patients . Conclusions This is the fifth independent study providing evidence that Mammostrat ® can act as an independent prognostic tool for ER-positive , tamoxifen-treated breast cancer . In addition , this study revealed for the first time a possible association with outcome regardless of node status and ER-negative tumors . When viewed in the context of previous results , these data provide further support for this antibody panel as an aid to patient management in early-stage breast cancer The development of tumor biomarkers ready for clinical use is complex . We propose a refined system for biomarker study design , conduct , analysis , and evaluation that incorporates a hierarchal level of evidence scale for tumor marker studies , including those using archived specimens . Although fully prospect i ve r and omized clinical trials to evaluate the medical utility of a prognostic or predictive biomarker are the gold st and ard , such trials are costly , so we discuss more efficient indirect " prospect ive-retrospective " design s using archived specimens . In particular , we propose new guidelines that stipulate that 1 ) adequate amounts of archived tissue must be available from enough patients from a prospect i ve trial ( which for predictive factors should generally be a r and omized design ) for analyses to have adequate statistical power and for the patients included in the evaluation to be clearly representative of the patients in the trial ; 2 ) the test should be analytically and preanalytically vali date d for use with archived tissue ; 3 ) the plan for biomarker evaluation should be completely specified in writing before the performance of biomarker assays on archived tissue and should be focused on evaluation of a single completely defined classifier ; and 4 ) the results from archived specimens should be vali date d using specimens from one or more similar , but separate , studies Purpose : To test the association between risk stratification and outcome in a prospect ively design ed , blinded retrospective study using tissue arrays of available paraffin blocks from the estrogen receptor – expressing , node-negative sample s from the National Surgical Adjuvant Breast and Bowel Project B14 and B20 tamoxifen and chemotherapy trials . Experimental Design : Tissue arrays were stained by immunohistochemistry targeting p53 , NDRG1 , SLC7A5 , CEACAM5 , and HTF9C . Risk stratification was done using predefined scoring rules , algorithm for combining scores , and cutoff points for low-risk , moderate-risk , and high-risk patient strata . Results : In a univariate Cox model , this test was significantly associated with recurrence-free interval [ HR , 1.3 ( 95 % confidence interval , 1.1 - 1.6 ) ; P = 0.006 ] . In a multivariate model it contributed information independent of age , tumor size , and menopausal status ( P = 0.007 ) . The Kaplan-Meier estimates of the proportion of recurrence-free after 10 years were 73 % , 86 % , and 85 % for the high-risk , moderate-risk , and low-risk groups ( P = 0.001 ) . The Kaplan-Meier estimates of the breast-cancer-specific-death rate were 23 % , 10 % , and 9 % ( P < 0.0001 ) . Exploratory analysis in patients ≥60 years old showed Kaplan-Meier estimates of the proportion of recurrence-free of 78 % , 89 % , and 92 % . Both high-risk and low-risk groups showed significant improvement on treatment with cytotoxic chemotherapy . Conclusions : Immunohistochemistry using five monoclonal antibodies assigns breast cancer patients to a risk index that was significantly associated with clinical outcome among the estrogen receptor – expressing , node-negative tamoxifen-treated patients . It seems that the test may be able to identify patients who have greater absolute benefit from adjuvant chemotherapy compared with unstratified patient population s. Exploratory analysis suggests that this test will be most useful in clinical decision making for postmenopausal patients Background We carried out a prospect i ve clinical study to evaluate the impact of the Recurrence Score ( RS ) on treatment decisions in early breast cancer ( EBC ) . Patients and methods A total of 379 eligible women with estrogen receptor positive ( ER+ ) , HER2-negative EBC and 0–3 positive lymph nodes were enrolled . Treatment recommendations , patients ' decisional conflict , physicians ' confidence before and after knowledge of the RS and actual treatment data were recorded . Results Of the 366 assessable patients 244 were node negative ( N0 ) and 122 node positive ( N+ ) . Treatment recommendations changed in 33 % of all patients ( N0 30 % , N+ 39 % ) . In 38 % of all patients ( N0 39 % , N+ 37 % ) with an initial recommendation for chemoendocrine therapy , the post-RS recommendation changed to endocrine therapy , in 25 % ( N0 22 % , N+ 39 % ) with an initial recommendation for endocrine therapy only to combined chemoendocrine therapy , respectively . A patients ' decisional conflict score improved by 6 % ( P = 0.028 ) and physicians ' confidence increased in 45 % ( P < 0.001 ) of all cases . Overall , 33 % ( N0 29 % , N+ 38 % ) of fewer patients actually received chemotherapy as compared with patients recommended chemotherapy pre-test . Using the test was cost-saving versus current clinical practice . Conclusion RS-guided chemotherapy decision-making result ed in a substantial modification of adjuvant chemotherapy usage in node-negative and node-positive ER+ EBC PURPOSE Patients with breast cancer experience progression and respond to treatment in diverse ways , but prognostic and predictive tools for the oncologist are limited . We have used gene expression data to guide the production of hundreds of novel antibody reagents to discover novel diagnostic tools for stratifying carcinoma patients . PATIENTS AND METHODS One hundred forty novel and 23 commercial antisera , selected on their ability to differentially stain tumor sample s , were used to stain paraffin blocks from a retrospective breast cancer cohort . Cox proportional hazards and regression tree analysis identified minimal panels of reagents able to predict risk of recurrence . We tested the prognostic association of these prospect ively defined algorithms in two independent cohorts . RESULTS In both validation cohorts , the Kaplan-Meier estimates of recurrence confirmed that both the Cox model using five reagents ( p53 , NDRG1 , CEACAM5 , SLC7A5 , and HTF9C ) and the regression tree model using six reagents ( p53 , PR , Ki67 , NAT1 , SLC7A5 , and HTF9C ) distinguished estrogen receptor (ER)-positive patients with poor outcomes . The Cox model was superior and distinguished patients with poor outcomes from patients with good or moderate outcomes with a hazard ratio of 2.21 ( P = .0008 ) in validation cohort 1 and 1.88 ( P = .004 ) in cohort 2 . In multivariable analysis , the calculated risk of recurrence was independent of stage , grade , and lymph node status . A model proposed for ER-negative patients failed validation in the independent cohorts . CONCLUSION A panel of five antibodies can significantly improve on traditional prognosticators in predicting outcome for ER-positive breast cancer patients The prognostic accuracy for distant recurrence‐free survival using a 21‐gene reverse
Output:
| The Recurrence Score has been shown to be an independent predictor of disease-free survival , overall survival , and distant recurrence-free interval in patients with ER+ , N+ EBC .
Outcomes from decision impact and health economics studies further indicate that the Recurrence Score affects physician treatment recommendations equally in patients with N+ or N0 disease .
It also indicates that a reduction in Recurrence Score-directed chemotherapy is cost-effective .
There is a large body of evidence to support the use of the 21-gene assay Recurrence Score in patients with N+ EBC .
Use of this assay could help guide treatment decisions for patients who are most likely to receive benefit from chemotherapy |
MS213252 | ***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 Health tests are often seen as promising donor incentives to improve the supply of blood . However , systematic behavioral evidence on donor recruitment is scarce . STUDY DESIGN AND METHODS To study the effectiveness of a free cholesterol test in attracting new donors and motivating previous donors , two field experiments were conducted . In Study 1 , 2825 nondonors were r and omly assigned to one of three treatments : a solicitation letter , a solicitation letter plus an appeal , or a solicitation letter plus an appeal and the offer of a free cholesterol test . In Study 2 , 8269 previous donors were r and omly assigned to one of three treatments : a st and ard invitation , an invitation plus an appeal , or an invitation plus an appeal and a cholesterol test . Marginal effects from probit estimations were calculated to study the effects of the treatments on donors ' response . RESULTS In Study 1 , only 0.6 percent reacted to the solicitation letter . There were no significant differences in the response rates between the three treatments . In Study 2 , 45.3 percent of the invited previous donors came to donate . The appeal ( marginal effect , -0.5 % ; st and ard error [ SE ] , 1.9 % ) and offering a cholesterol test ( marginal effect , 1.6 % ; SE , 1.8 % ) did not significantly increase the probability of a donation relative to the st and ard invitation . The treatment effects for the cholesterol test did not systematic ally differ between frequent and infrequent donors and female and male donors . There is some evidence that young donors responded relatively most positive to the cholesterol test ( marginal effect , 4.4 % ; SE , 2.2 % ) . CONCLUSIONS Contrary to conclusions from survey studies , free cholesterol testing did not significantly increase donations from nondonors and previous donors during a 3-month campaign . The two studies show that field experiments are an important method to evaluate donation incentives , because measuring donors ' intentions alone can lead to significantly different conclusions BACKGROUND Some blood donation-related adverse events ( AEs ) can negatively impact the blood donor return rate ( BDRR ) and decrease donor retention . STUDY DESIGN AND METHODS One-thous and r and omly selected whole-blood donors were interviewed 3 weeks after a 525-mL index whole-blood donation for seven AEs . The number of return visits and duration of follow-up were recorded for each of the 1000 donors . A negative binomial regression analysis was used to determine the contribution of the four most common AEs to the BDRR , and interactions between these AEs were also evaluated . RESULTS The four most common AEs were bruise alone ( 15.1 % ) , sore arm " alone " ( 7.0 % ) , fatigue " alone " ( 5.1 % ) , and donor reaction " alone " ( 4.2 % ) , where " alone " is defined to also include donors who had a bruise but no other AE . The estimated BDRR for donations without AEs was 1.32 visits per year . The estimated BDRRs for the four most common AEs were : bruise alone , 1.32 visits per year ; sore arm alone , 1.30 visits per year ( 2 % reduction in BDRR ) ; fatigue alone , 1.06 visits per year ( 20 % reduction in BDRR ) ; and donor reaction alone , 0.87 visits per year ( 34 % reduction in BDRR ) . The BDRR for donor reaction , fatigue , and sore arm together was 0.20 visits per year ( 85 % reduction in BDRR ) . CONCLUSION Donor reaction had the most negative impact on the BDRR . There appears to be a synergistic effect between donor reaction , fatigue , and sore arm . Theoretically , amelioration of some AEs has the potential to improve BDRRs BACKGROUND There are no reports in the transfusion medicine literature that describe adverse reactions and donor arm injuries after whole-blood donation based on solicited information . STUDY DESIGN AND METHODS The present study solicited adverse reaction and donor arm injury information from 1000 r and omly selected whole-blood donors approximately 3 weeks after the whole-blood donation . Two 16-gauge phlebotomy needles in use were also compared . RESULTS Thirty-six percent of the donors had one or more adverse effects ( AEs ) . The most common systemic AEs were fatigue ( 7.8 % ) , vasovagal symptoms ( 5.3 % ) , and nausea and vomiting ( 1.1 % ) . The most common arm findings were bruise ( 22.7 % ) , arm soreness ( 10.0 % ) , and hematoma ( 1.7 % ) . Men were half as likely as women to have an AE ( 23 % AE vs. 48 % AE , p < 0.0001 ) . Repeat blood donors had fewer AEs than first-time blood donors ( 36 % AE vs. 47 % AE , p < 0.007 ) , and African-American donors had numbers of AEs similar to those of Caucasian donors ( 31 % AE vs. 38 % AE , p = 0.30 ) . The two phlebotomy needles did not differ in causing blood donor AEs . CONCLUSION AEs after donation and complaints may be more common than previously thought . The postdonation interview is a good tool for defining the blood donor 's experience . It can also be used to evaluate and potentially improve blood donor safety and comfort BACKGROUND Blood supplies in Greece are insufficient to meet the high transfusion needs arising from car accidents and treatment of thalassaemia . This study was design ed to determine Greeks ' opinions about blood donation , in order to identify the reasons for the lack of motivation to donate and allow experts to establish better recruitment campaigns for the enrichment of the donor pool , based on our findings . MATERIAL S AND METHODS The opinions of r and omly selected Greek citizens ( n=800 ) about volunteer blood donation were assessed by means of a st and ardised , anonymous question naire . The results were analysed using the χ(2 ) test and Spearman 's correlation coefficient . RESULTS With regards to attitudes towards intention to donate , only 7.1 % were indifferent , while 88.0 % of the individuals believed that donating blood was an " offer " . Reasons for not donating mainly involved safety ( 36.0 % ) and fear ( 24.0 % ) , whereas need ( 77.9 % ) was the most fundamental positive motivation . Of the people enrolled in the present study , 10.0 % were active donors , 31.3 % occasional donors , 15.0 % rare donors and 36.6 % non-donors . DISCUSSION The considerable percentages of occasional and rare donors in comparison with the low proportion of active donors in the Greek donor pool indicates that " need " is a more important motivation for blood donation than altruism in Greece . These results could be useful for establishing advertising campaigns on blood donation and for a more direct approach to the population , aim ing for a change in mentality in favour of active blood donation
Output:
| RESULTS Among 28 identified articles , the most frequently cited motivators for male blood product donation were as follows : altruism ; positive attitude towards incentives ; health check(s ) ; subjective norms .
Altruism was less pronounced among males compared with females and was combined with ' warm glow ' in novice males ( impure altruism ) .
Perceived health benefits and incentives ( e.g. coffee mugs ) were stronger motivators of males than females . |
MS213253 | ***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 determine the effect of intercessory prayer , a widely practice d complementary therapy , on cardiovascular disease progression after hospital discharge . PATIENTS AND METHODS In this r and omized controlled trial conducted between 1997 and 1999 , a total of 799 coronary care unit patients were r and omized at hospital discharge to the intercessory prayer group or to the control group . Intercessory prayer , ie , prayer by 1 or more persons on behalf of another , was administered at least once a week for 26 weeks by 5 intercessors per patient . The primary end point after 26 weeks was any of the following : death , cardiac arrest , rehospitalization for cardiovascular disease , coronary revascularization , or an emergency department visit for cardiovascular disease . Patients were divided into a high-risk group based on the presence of any of 5 risk factors ( age = or > 70 years , diabetes mellitus , prior myocardial infa rct ion , cerebrovascular disease , or peripheral vascular disease ) or a low-risk group ( absence of risk factors ) for subsequent primary events . RESULTS At 26 weeks , a primary end point had occurred in 25.6 % of the intercessory prayer group and 29.3 % of the control group ( odds ratio [ OR ] , 0.83 [ 95 % confidence interval ( CI ) , 0.60 - 1.14 ] ; P=.25 ) . Among high-risk patients , 31.0 % in the prayer group vs 33.3 % in the control group ( OR , 0.90 [ 95 % CI , 0.60 - 1.34 ] ; P=.60 ) experienced a primary end point . Among low-risk patients , a primary end point occurred in 17.0 % in the prayer group vs 24.1 % in the control group ( OR , 0.65 [ 95 % CI , 0.20 - 1.36 ] ; P=.12 ) . CONCLUSIONS As delivered in this study , intercessory prayer had no significant effect on medical outcomes after hospitalization in a coronary care unit OBJECTIVE Little is known about the effects of distant healing in chronically ill patients , the population most likely to see a healer in practice . This study investigated whether distant healing as found in normal practice with patients representative of those seeking treatment from healers changes patients ' quality of life substantially . METHOD R and omized , waiting-list controlled study of distant healing ( anonymous , amulet , and allowing for personal contact ) in chronically ill patients . OUTCOME MEASURE Patient-reported quality of life as expressed by the sum of all MOS SF-36 health survey items . RESULTS Sixty patients were treated by various methods of distant healing over 5 months ; 59 patients were put on a waiting list ( control ) . Quality of life improved significantly ( p < 0.0005 ) in the treated group ( 10 points ) , while it remained stable in the control group . Positive expectation was significantly correlated with outcome . CONCLUSION Chronically ill patients who want to be treated by distant healing and know that they are treated improve in quality of life The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas The therapeutic effects of intercessory prayer ( IP ) to the Judeo-Christian God , one of the oldest forms of therapy , has had little attention in the medical literature . To evaluate the effects of IP in a coronary care unit ( CCU ) population , a prospect i ve r and omized double-blind protocol was followed . Over ten months , 393 patients admitted to the CCU were r and omized , after signing informed consent , to an intercessory prayer group ( 192 patients ) or to a control group ( 201 patients ) . While hospitalized , the first group received IP by participating Christians praying outside the hospital ; the control group did not . At entry , chi-square and stepwise logistic analysis revealed no statistical difference between the groups . After entry , all patients had follow-up for the remainder of the admission . The IP group subsequently had a significantly lower severity score based on the hospital course after entry ( P<.01 ) . Multivariant analysis separated the groups on the basis of the outcome variables ( P<.0001 ) . The control patients required ventilatory assistance , antibiotics , and diuretics more frequently than patients in the IP group . These data suggest that intercessory prayer to the Judeo-Christian God has a beneficial therapeutic effect in patients admitted to a CCU OBJECTIVE To conduct a pilot study of the effect of intercessory prayer on patients entering treatment for alcohol abuse or dependence . DESIGN In addition to st and ard treatment , 40 patients admitted to a public substance abuse treatment facility for treatment of alcohol problems who consented to participate were r and omized to receive or not receive intercessory prayer ( double-blind ) by outside volunteers . Assessment s were conducted at baseline , 3 months , and 6 months . RESULTS No differences were found between prayer intervention and nonintervention groups on alcohol consumption . Compared with a normative group of patients treated at the same facility participants in the prayer study experienced a delay in drinking reduction . Those who reported at baseline that a family member or friend was already praying for them were found to be drinking significantly more at 6 months than were those who reported being unaware of anyone praying for them . Greater frequency of prayer by the participants themselves was associated with less drinking , but only at months 2 and 3 . CONCLUSION Intercessory prayer did not demonstrate clinical benefit in the treatment of alcohol abuse and dependence under these study conditions . Prayer may be a complex phenomenon with many interacting variables BACKGROUND The effect of intercessory prayer ( IP ) on outcome in cardiac cases has been evaluated previously , but results are controversial . The goals of the Study of the Therapeutic Effects of Intercessory Prayer ( STEP ) are to evaluate the effects of receipt of additional study IP and awareness of receipt of additional study IP on outcomes in patients undergoing coronary artery bypass graft surgery . STEP is not design ed to determine whether God exists or whether God does or does not respond to IP . METHODS STEP is a multicenter , controlled trial of 1802 patients in 6 US hospitals , r and omized to 1 of 3 groups . Two groups were informed that they may or may not receive 14 consecutive days of additional IP starting the night before coronary artery bypass graft surgery ; Group 1 received IP , Group 2 did not . A third group ( Group 3 ) was informed that they would receive additional IP and did so . Three mainstream religious sites provided daily IP for patients assigned to receive IP . At each hospital , research nurses blinded to patient group assignment review ed medical records to determine whether complications occurred , on the basis of the Society for Thoracic Surgeons definitions . A blinded nurse auditor from the Coordinating Center review ed every study patient 's data against the medical record before release of study forms . RESULTS The STEP Data and Safety Monitoring Board review ed patient safety and outcomes in the first 900 study patients . Patients were enrolled in STEP from January 1998 to November 2000 Abstract Objective : To determine whether remote , retroactive intercessory prayer , said for a group of patients with a bloodstream infection , has an effect on outcomes . Design : Double blind , parallel group , r and omised controlled trial of a retroactive intervention . Setting : University hospital . Subjects : All 3393 adult patients whose bloodstream infection was detected at the hospital in 1990 - 6 . Intervention : In July 2000 patients were r and omised to a control group and an intervention group . A remote , retroactive intercessory prayer was said for the well being and full recovery of the intervention group . Main outcome measures : Mortality in hospital , length of stay in hospital , and duration of fever . Results : Mortality was 28.1 % ( 475/1691 ) in the intervention group and 30.2 % ( 514/1702 ) in the control group ( P for difference=0.4 ) . Length of stay in hospital and duration of fever were significantly shorter in the intervention group than in the control group ( P=0.01 and P=0.04 , respectively ) . Conclusions : Remote , retroactive intercessory prayer said for a group is associated with a shorter stay in hospital and shorter duration of fever in patients with a bloodstream infection and should be considered for use in clinical practice . What is already known on this topic Two r and omised controlled trials of remote intercessory prayer ( praying for persons unknown ) showed a beneficial effect in patients in an intensive coronary care unit A recent systematic review found that 57 % of the r and omised , placebo controlled trials of distant healing showed a positive treatment effect What this study adds Remote intercessory prayer said for a group of patients is associated with a shorter hospital stay and shorter duration of fever in patients with a bloodstream infection , even when the intervention is performed 4–10 years after the Various forms of distant healing ( DH ) , including prayer and " psychic healing , " are widely practice d , but insufficient formal research has been done to indicate whether such efforts actually affect health . We report on a double-blind r and omized trial of DH in 40 patients with advanced AIDS . Subjects were pair-matched for age , CD4 + count , and number of AIDS-defining illnesses and r and omly selected to either 10 weeks of DH treatment or a control group . DH treatment was performed by self-identified healers representing many different healing and spiritual traditions . Healers were located throughout the United States during the study , and subjects and healers never met . Subjects were assessed by psychometric testing and blood draw at enrollment and followed for 6 months . At 6 months , a blind medical chart review found that treatment subjects acquired significantly fewer new AIDS-defining illnesses ( 0.1 versus 0.6 per patient , P = 0.04 ) , had lower illness severity ( severity score 0.8 versus 2.65 , P = 0.03 ) , and required significantly fewer doctor visits ( 9.2 versus 13.0 , P = 0.01 ) , fewer hospitalizations ( 0.15 versus 0.6 , P = 0.04 ) , and fewer days of hospitalization ( 0.5 versus 3.4 , P = 0.04 ) . Treated subjects also showed significantly improved mood compared with controls ( Profile of Mood States score -26 versus 14 , P = 0.02 ) . There were no significant differences in CD4 + counts . These data support the possibility of a DH effect in AIDS and suggest the value of further research BACKGROUND Patients undergoing percutaneous coronary intervention ( PCI ) for unstable coronary syndromes have substantial emotional and spiritual distress that may promote procedural complications . Noetic ( nonpharmacologic ) therapies may reduce anxiety , pain and distress , enhance the efficacy of pharmacologic agents , or affect short- and long-term procedural outcomes . METHODS The Monitoring and Actualization of Noetic Training ( MANTRA ) pilot study examined the feasibility of applying 4 noetic therapies-stress relaxation , imagery , touch therapy , and prayer-to patients in the setting of acute coronary interventions . Eligible patients had acute coronary syndromes and invasive angiography or PCI . Patients were r and omized across 5 treatment groups : the 4 noetic and st and ard therapies . Question naires completed before PCI reflected patients ' religious beliefs and anxiety . Index hospitalization end points included post-PCI ischemia , death , myocardial infa rct ion , heart failure , and urgent revascularization . Mortality was followed up for 6 months after hospitalization . RESULTS Of eligible patients , 88 % gave informed consent . Of 150 patients enrolled , 120 were assigned to noetic therapy ; 118 ( 98 % ) completed their therapeutic assignments . All clinical end points were available for 100 % of patients . Results were not statistically significant for any outcomes comparisons . There was a 25 % to 30 % absolute reduction in adverse periprocedural outcomes in patients treated with any noetic therapy compared with st and ard therapy . The lowest absolute complication rates were observed in patients assigned to off-site prayer . All mortality by 6-month follow-up was in the noetic therapies group . In patients with question naire scores indicating a high level of spiritual belief , a high level of personal spiritual activity , a low level of community-based religious involvement , or a high level of anxiety , noetic therapies appeared to show greater reduction in absolute in-hospital complication rates compared with st and ard therapy . CONCLUSIONS Acceptance of noetic adjuncts to invasive therapy for acute coronary syndromes was excellent , and logistics were feasible . No outcomes differences were significant ; however , index hospitalization data consistently suggested a therapeutic benefit with noetic therapy . Of all noetic therapies , off-site intercessory prayer had the lowest short- and long-term absolute complication rates . Definitive demonstr
Output:
| Individual studies did find some effects .
However it is impossible to prove or disprove in trials any supposed benefit that derives from God 's response to prayer |
MS213254 | ***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: Most clinical trials investigating prevention of seasickness with transdermal scopolamine have been short-term , and little information regarding long-term use is available . We report here a double-blind trial conducted on board a flat-bottomed Republic of Singapore Navy vessel of 2,490 tons , sailing in the South China Sea . The trip lasted 26 d , but self- assessment by the 122 adult male participants ( using a simplified scale quantifying the level of seasickness ) was confined to the 18 d spent at sea . We found that the protection rate with transdermal scopolamine was 46 - 57 % , with maximum benefits to inexperienced participants , during the early preadaptation phase , or in rough seas even after adaptation . Unwanted effects were few and generally minor . We concluded that the benefits of Scopoderm were worth exploiting even for long trips in moderate-to-rough seas In two placebo-controlled , double-blind , r and omized trials scopolamine ( 0.3 mg ) alone or combined with ephedrine ( 25 mg ) was tested for its effectiveness in the prevention of seasickness during 24 h at sea and of motion sickness in rotating chair tests in a laboratory . Scopolamine was effective both alone and in combination with ephedrine , which supports the hypothesis on central cholinergic overactivity in the pathogenesis of motion sickness . Ephedrine did not markedly increase the effectiveness of scopolamine . Side-effects were slight and did not disturb the operating ability of the volunteers The effect of transdermally administered scopolamine ( TTS scopolamine ) ( release rate 5 micrograms/h ) and dimenhydrinate ( 100 mg ) was examined on optovestibular nystagmus in 16 volunteers in a r and omized double-blind trial . A statistically significant decrease in the optokinetic part of nystagmus was observed during all treatments . Most profound reduction was found during treatment with two TTS scopolamine . The vestibular part was reduced by treatment with two TTS scopolamine , only . The results indicate that scopolamine and dimenhydrinate exert their effect in motion sickness by reducing the vestibular and visual influx and by partly inhibiting the integrative functioning of the vestibular nuclei . In their action , the motion sickness drugs seem to assist the cerebellum by diminishing impulses from various orientation reflexes in order to preserve the functional capacity of the central nervous system . Different symptoms in motion sickness seem to arise when the vestibular gain operates beyond the normal range of the cerebellar control mechanisms Space motion sickness has been estimated as affecting between 1/3 and 1/2 of all space flight participants . NASA has at the moment proposed a combination of promethazine and ephedrine ( P/E ) and one of scopolamine and dextroamphetamine ( S/D ) , both given orally , as well as a transdermally applied scopolamine ( TAS ) , as preventive and ameliorative measures . The reported double-blind study , tests the early phase actions and efficacy of the transdermal scopolamine ( Transderm (TM)-V of ALZA Corporation ) and compares these in detail to the oral medications . Motion sickness resistance was tested by st and ardized head movements while accelerating at 0.2 degree/sec2 to a maximum rotation of 240 degrees/sec , with an intermediate plateau of 10 min at 180 degrees/sec . To permit weighting motion sickness protection against other system influences , cardiovascular , psychological ( subjective and objective ) , and visual parameter changes were documented for the three therapeutic modes . The relative impact of the various modalities on operational and experimental components of space missions is discussed . A comparison to intramuscularly administered promethazine ( a backup therapeutic mode suggested for Space Shuttle use ) is also included Summary Three placebo-controlled double-blind studies in healthy volunteers were performed to reveal the psychophysiological effects of scopolamine , ephedrine and their combination . Single intravenous dose of scopolamine 6 µg/kg ( scopolamine hydrobromide 7.4 µg/kg ) impaired various psychomotor functions both subjectively and objective ly . It caused sedation , impairment of coordinative and reactive skills , visual disturbances and impairment of short-term memory . Oral scopolamine hydrobromide in single doses of 0.3 mg and 0.9 mg , or 0.9 mg b.d . for 3 days , had few effects . A slight impairment of short-term memory and a decrease in the flicker fusion threshold were seen . The visual nearpoint and pupil diameter were increased and some subjects reported blurred vision and dizziness during treatment with scopolamine 0.9 mg b.d . Scopolamine showed clear cardiovascular effects in all studies : it decreased heart rate and systolic blood pressure . Ephedrine alone and in combination with scopolamine had no deleterious effects . On the contrary , it antagonized the scopolamine-induced impairment in the flicker fusion test and the decrease in blood pressure and heart rate . In sufficient doses scopolamine impairs various psychomotor and cognitive skills . An oral dose of scopolamine hydrobromide 0.9 mg on average has few effects , although they may be very striking in certain individuals . To avoid unwanted effects and diminition in performance by scopolamine , doses less than 0.9 mg should be used Treatment of acute motion sickness induced by parabolic flight with a preparation of scopolamine placed in the buccal pouch was investigated . Twenty-one subjects flew aboard a KC-135 aircraft operated by the National Aeronautics and Space Administration ( NASA ) which performed parabolic maneuvers result ing in periods of 0-g , 1-g , and 1.8-g . Each subject flew once with a tablet containing scopolamine and once with a placebo in a r and om order , crossover design . Signs and symptoms of motion sickness were systematic ally recorded during each parabola by an investigator who was blind to the content of the tablet . Compared with flights using placebo , flights with buccal scopolamine result ed in significantly lower scores for nausea ( 31%-35 % reduction ) and vomiting ( 50 % reduction in number of parabolas with vomiting ) . Side effects of the drug during flight were negligible . We conclude that buccal scopolamine is more effective than a placebo in treating ongoing motion sickness The efficacy and tolerability of Scopoderm TTS ( SCOTTS ) , a transdermal system containing scopolamine , were compared with those of the oral antiemetic dimenhydrinate ( double-dummy technique ) in a controlled , double-blind , within-patient study including 20 test persons with proven motion sickness . During a 1-h test flight , SCOTTS proved to be as effective as dimenhydrinate . The efficacy and tolerability of both SCOTTS and dimenhydrinate were assessed as to be equally good . Due to its galenic properties , SCOTTS is effective over a 72-h period and therefore is useful in the prevention of motion sickness during long-distance flights , where it is superior to dimenhydrinate INTRODUCTION Despite many existing treatments , airsickness is an issue of concern for soldiers being transported by helicopter . This experiment examined the efficacy of four airsickness treatments and their effects on performance . This study replicated the transport of soldiers in the cabin of an UH-60 Black Hawk helicopter performing many of the flight maneuvers potentially experienced in a night troop transport during turbulent conditions . METHODS A double-blinded , placebo-controlled design was used to compare the effectiveness of four airsickness counter measures to their placebo controls . There were 64 male , non-aviator subjects ( ages 18 - 34 yr ) who were recruited for the study . Of these , 16 subjects were r and omly assigned to each of 4 groups : ( 1 ) promethazine ( 25 mg ) + caffeine ( 200 mg ) ; ( 2 ) meclizine ( 25 mg ) ; ( 3 ) Scopolamine patch ( 1.5 mg ) ; and 4 ) acustimulation wristb and . Each individual participated twice , once with the treatment and once with placebo . RESULTS The findings indicated that only the combination of promethazine + caffeine showed a statistically significant reduction in nausea and motion sickness severity , and an improvement in reaction time when compared with its placebo control . DISCUSSION Data from this study indicated that of the counter measures tested , promethazine + caffeine was the most effective at reducing airsickness while producing the fewest side effects when compared with its placebo . In addition , this study demonstrated that over-the-counter caffeine can serve as an effective stimulant counterpart to promethazine . This may be a more appealing option than employing scheduled sympathomimetic drugs in a combat environment Objective : Space motion sickness is currently treated pharmacologically with the empiric use of the H1 antihistamine promethazine , but use of this intervention is limited by the side effect of significant sedation . This creates a dilemma , as full cognition is particularly important during the same conditions likely to exacerbate the symptoms of space motion sickness . Using overstimulation of the semicircular canals with a rotary chair as a paradigm for space motion sickness , we evaluated four medications , commonly used for the treatment of terrestrial motion sickness and vertigo , for their efficacy in alleviating the simulated symptoms of space motion sickness . Study Design : R and omized , prospect i ve , double-blind study . Setting : Tertiary referral center . Patients : Healthy male and female volunteers , 18 years of age or older , without history of neurologic or psychiatric disorders , and with no known allergies or any previous adverse reactions to the drugs used . Interventions : Lorazepam 1 mg , meclizine 25 mg , promethazine 25 mg , scopolamine 0.4 mg , or placebo . Main Outcome Measure : The ability of each treatment to control the nausea and vomiting associated with our paradigm for space motion sickness was evaluated by measuring time of rotation pre- and posttreatment and time of symptom onset pre- and posttreatment . Results : Only scopolamine effected a mean change in duration of rotation that reached statistical significance when compared with placebo ( p < 0.008 ) , with a greater than 40 % increase in rotation time . Results with promethazine were not statistically significant . Conclusion : Results showed a rank order of efficacy of scopolamine > promethazine > placebo > meclizine > lorazepam . Scopolamine significantly increased rotation time , but none of the treatments result ed in a significant delay to onset of symptoms Transdermal scopolamine has been reported to provide protection against motion sickness , both while sailing at sea ( 7 - 8 h ) and under experimental conditions . In this study , we tested the efficacy of transdermal scopolamine and evaluated its side effects during a 72-h cruise at sea . We tested 38 male volunteers , 20 - 25 years old , who were located on a 3000-ton vessel . The presence of seasickness , defined by Graybiel 's diagnostic criteria , was used to calculate percent protection . When sickness was considered as malaise II or more , the drug provided 74 , 73 , and 39 % protection during the three sailing days , respectively . There were no significant differences in the magnitude of the side effects reported by experimental and placebo groups . We conclude that transdermal scopolamine 's efficacy against seasickness during a 3-day cruise was not associated with significant side effects and , therefore , we find the drug suitable for long-term use by sailing crews We conducted a double‐blind , placebo‐controlled study to evaluate the efficacy and tolerability of transdermal scopolamine in the prevention of motion sickness ( MS ) aboard a frigate during 7 days of continuously moderate or heavy seas . Forty‐nine healthy sailors with a previous history of MS were r and omly assigned to receive a transdermal therapeutic system of scopolamine ( TTS‐S ) or transdermal placebo ( TD‐P ) . Patches were placed behind the ears at least 4 hours before departure and were removed 72 hours later . Subjects were observed on days 1 to 4 and 6 . In the TTS‐S group , both subjective feeling of MS and the incidence of nausea were reduced during the first 2 days . Because of adaptation , differences in signs and symptoms of MS between subjects receiving TTS‐S and TD‐P disappeared after the second day . During the first 3 days , vomiting occurred less often in the TTS‐S group . On day 6 , 3 days after removal of the patch , vomiting occurred in 23 % of the TTS‐S group , probably due to delay in adaptation , but none of the subjects in the TD‐P group vomited . Concentration was not adversely influenced , since the ability to work increased in the TTS‐S group . During prolonged continuous exposure to heavy and moderate seas , 2.5 cm2 TTS‐S discs proved to be efficacious in preventing MS , with xerostomia as a tolerable side effect and no significant ocular side effects The effects of transdermally administered scopolamine ( TTS-scopolamine ) ( release rate 5 micrograms/h , one and two patches ) and dimenhydrinate ( 100 mg ) on caloric , angular acceleration induced and optokinetic nystagmus were examined in 16 volunteers in a r and omized double-blind study . All drugs induced a statistically significant decrease in maximum velocity of caloric nystagmus , as compared with placebo . In the rotatory test , two TTS-scopolamine and dimenhydrinate reduced the vestibular gain significantly . No changes were observed in time constant . In the optokinetic test , all dru
Output:
| Studies were generally small in size and of varying quality .Scopolamine was more effective than placebo in the prevention of symptoms .
Comparisons between scopolamine and other agents were few and suggested that scopolamine was superior ( versus methscopolamine ) or equivalent ( versus antihistamines ) as a preventative agent .
Although sample sizes were small , scopolamine was no more likely to induce drowsiness , blurring of vision or dizziness compared to other agents .
Dry mouth was more likely with scopolamine than with methscopolamine or cinnarizine .
The use of scopolamine versus placebo in preventing motion sickness has been shown to be effective .
No conclusions can be made on the comparative effectiveness of scopolamine and other agents such as antihistamines and calcium channel antagonists . |
MS213255 | ***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: Study Design . A r and omized trial . Objective . To evaluate the effectiveness of a semi-intensive multidisciplinary rehabilitation for patients with chronic low back pain in an outpatient setting . Summary and Background Data . Systematic review s have shown that there is strong evidence that intensive multidisciplinary treatment ( > 100 hours ) , which includes functional restoration , improves function among chronic patients with low back pain , and moderate evidence that it reduces pain but contradictory evidence regarding improvement of working ability . However , there is paucity of data whether semi-intensive outpatient multidisciplinary rehabilitation in groups is more effective than individual physiotherapy . Material s and Methods . A total of 120 women employed as healthcare and social care professionals with nonspecific chronic low back pain were recruited from two occupational healthcare centers . The patients were r and omized into two intervention programs . Multidisciplinary rehabilitation ( n = 59 ) was conducted in groups and comprised of physical training , workplace interventions , back school , relaxation training , and cognitive-behavioral stress management methods for 70 hours . The individual physiotherapy ( n = 61 ) included physical exercise and passive treatment methods administered for 10 hours . Main outcome measures were : back pain and sciatic pain intensity , disability , sick leaves , healthcare consumption , symptoms of depression , and beliefs of working ability after 2 years . Results . There were no statistically significant differences between the two treatment groups in main outcome measures just after rehabilitation , at 6- , at 12- , or 24-month follow-up . In both intervention arms , however , the before- and -after comparison showed favorable effects , and the effects were still maintained at 2 years follow-up . Conclusions . The results of this study indicate that semilight outpatient multidisciplinary rehabilitation program for female chronic low back pain patients does not offer incremental benefits when compared with rehabilitation carried out by a physiotherapist having a cognitive-behavioral way of administering the treatment Study Design . A prospect i ve r and omized controlled trial . Objectives . To examine the effectiveness of combined manipulative treatment , stabilizing exercises , and physician consultation compared with physician consultation alone for chronic low back pain . Summary of Background Data . Strong evidence exists that manual therapy provides more effective short-term pain relief than does placebo treatment in the management of chronic low back pain . The evidence for long-term effect is lacking . Methods . Two hundred four chronic low back pain patients , whose Oswestry disability index was at least 16 % , were r and omly assigned to either a manipulative-treatment group or a consultation group . All were clinical ly examined , informed about their back pain , provided with an educational booklet , and were given specific instructions based on the clinical evaluation . The treatment included four sessions of manipulation and stabilizing exercises aim ing to correct the lumbopelvic rhythm . Question naires inquired about pain intensity , self-rated disability , mental depression , health-related quality of life , health care costs , and production costs . Results . At the baseline , the groups were comparable , except for the percentage of employees ( P = 0.01 ) . At the 5- and 12-month follow-ups , the manipulative-treatment group showed more significant reductions in pain intensity ( P < 0.001 ) and in self-rated disability ( P = 0.002 ) than the consultation group . However , we detected no significant difference between the groups in health-related quality of life or in costs . Conclusions . The manipulative treatment with stabilizing exercises was more effective in reducing pain intensity and disability than the physician consultation alone . The present study showed that short , specific treatment programs with proper patient information may alter the course of chronic low back pain OBJECTIVE To evaluate the effectiveness of the addition of back school to exercise and physical treatment modalities in relieving pain and improving the functional status of patients with chronic low back pain . DESIGN A r and omized controlled trial . PATIENTS A total of 146 patients with chronic low back pain were enrolled in the study . METHODS Subjects were divided into 2 groups : the back school group received exercise , physical treatment modalities and a back school programme ; and the control group received exercise and physical treatment modalities . Treatment efficacy was evaluated at the end of treatment and 3 months post-treatment , in terms of pain , measured with the Visual Analogue Scale , and functional status , measured with the Oswestry Low Back Pain Disability Question naire . RESULTS In both groups , Visual Analogue Scale and Oswestry Low Back Pain Disability Question naire were significantly reduced after therapy ( p < 0.01 ) , but the difference between the scores at the end of treatment and 3 months post-treatment was not significant . There was a significant improvement in Visual Analogue Scale and Oswestry Low Back Pain Disability Question naire in the back school group compared with the control group at the end of therapy and 3 months post-treatment ( p < 0.05 ) . CONCLUSION The addition of back school was more effective than exercise and physical treatment modalities alone in the treatment of patients with chronic low back pain Study Design . A r and omized controlled trial with a 6-month follow-up period was conducted . Objective . To compare lumbar extension exercise and whole-body vibration exercise for chronic lower back pain . Summary of Background Data . Chronic lower back pain involves muscular as well as connective and neural systems . Different types of physiotherapy are applied for its treatment . Industrial vibration is regarded as a risk factor . Recently , vibration exercise has been developed as a new type of physiotherapy . It is thought to activate muscles via reflexes . Methods . In this study , 60 patients with chronic lower back pain devoid of “ specific ” spine diseases , who had a mean age of 51.7 years and a pain history of 13.1 years , practice d either isodynamic lumbar extension or vibration exercise for 3 months . Outcome measures were lumbar extension torque , pain sensation ( visual analog scale ) , and pain-related disability ( pain disability index ) . Results . A significant and comparable reduction in pain sensation and pain-related disability was observed in both groups . Lumbar extension torque increased significantly in the vibration exercise group ( 30.1 Nm/kg ) , but significantly more in the lumbar extension group ( + 59.2 Nm/kg ; SEM 10.2;P < 0.05 ) . No correlation was found between gain in lumbar torque and pain relief or pain-related disability ( P > 0.2 ) . Conclusions . The current data indicate that poor lumbar muscle force probably is not the exclusive cause of chronic lower back pain . Different types of exercise therapy tend to yield comparable results . Interestingly , well-controlled vibration may be the cure rather than the cause of lower back pain Background The evidence that exercise intervention is effective for treatment of chronic low back pain comes from trials that are not placebo-controlled . Objective The purpose of this study was to investigate the efficacy of motor control exercise for people with chronic low back pain . Design This was a r and omized , placebo-controlled trial . Setting The study was conducted in an outpatient physical therapy department in Australia . Patients The participants were 154 patients with chronic low back pain of more than 12 weeks ’ duration . Intervention Twelve sessions of motor control exercise ( ie , exercises design ed to improve function of specific muscles of the low back region and the control of posture and movement ) or placebo ( ie , detuned ultrasound therapy and detuned short-wave therapy ) were conducted over 8 weeks . Measurements Primary outcomes were pain intensity , activity ( measured by the Patient-Specific Functional Scale ) , and patient 's global impression of recovery measured at 2 months . Secondary outcomes were pain ; activity ( measured by the Patient-Specific Functional Scale ) ; patient 's global impression of recovery measured at 6 and 12 months ; activity limitation ( measured by the Rol and -Morris Disability Question naire ) at 2 , 6 , and 12 months ; and risk of persistent or recurrent pain at 12 months . Results The exercise intervention improved activity and patient 's global impression of recovery but did not clearly reduce pain at 2 months . The mean effect of exercise on activity ( measured by the Patient-Specific Functional Scale ) was 1.1 points ( 95 % confidence interval [CI]=0.3 to 1.8 ) , the mean effect on global impression of recovery was 1.5 points ( 95 % CI=0.4 to 2.5 ) , and the mean effect on pain was 0.9 points ( 95 % CI=−0.01 to 1.8 ) , all measured on 11-point scales . Secondary outcomes also favored motor control exercise . Limitation Clinicians could not be blinded to the intervention they provided . Conclusions Motor control exercise produced short-term improvements in global impression of recovery and activity , but not pain , for people with chronic low back pain . Most of the effects observed in the short term were maintained at the 6- and 12-month follow-ups Prospect i ve inception cohort . To assess the prognostic value of spinal mechanical load , assessed with the 24-hour schedule ( 24HS ) , in subjects with acute non-specific low back pain ( ALBP ) and to examine the influence of spinal mechanical load on the course of ALBP . In view of the characteristics of the natural course of ALBP , this should be viewed as a persistent condition in many patients rather that a benign self-limiting disease . Therefore , secondary prevention could be beneficial . Spinal mechanical load is a risk factor for ALBP and possibly a ( modifiable ) prognostic factor for persistent ( i.e. recurrent and /or chronic ) LBP . One hundred patients from primary care with ALBP were eligible for inclusion . At 6 months , 88 subjects completed the follow-up . For the follow-up assessment a research assistant , unaware of our interest in the prognostic factors , contacted the subjects by telephone . Question naires were completed focusing on changes in demographic data and on the course and current status of ALBP . Persistent LBP occurred in 60 % subjects . After multivariate regression analysis smoking ( harmful ) and advanced age ( protective ) were associated with persistent LBP . Differences in 24HS scores at baseline and follow-up were univariate-related to persistent LBP . Spinal mechanical load , quantified with the 24HS , is not a prognostic factor for persistent LBP . Modification of spinal mechanical load in terms of 24HS scores could be beneficial for secondary prevention in patients with acute LBP Study Design . A r and omized controlled design superimposed on treatment as usual was used to compare the effects of a cognitive-behavior intervention aim ed at preventing chronicity with two different forms of information . Objective . To develop a coping-oriented preventive intervention applicable in primary care , and to compare its impact with educational information . Summary of Background Data . Preventing long-term disability result ing from spinal pain has proved difficult . The information provided by health care professions and early interventions aim ed at preventing long-term disability may be important , but little scientific evidence exists concerning their use . Methods . A protocol for a six-session cognitive-behavior group intervention was developed on the basis of earlier research . The main focus was to prevent long-term disability by changing patients ’ behaviors and beliefs so they can cope better with their problems . Comparison groups received either a pamphlet shown earlier to have an effect , or a more extensive information package consisting of six installments . All the groups continued to receive treatment as usual in primary care . There were 243 patients with acute or subacute spinal pain who perceived that they were at risk for developing a chronic problem . These patients were r and omized to the cognitive-behavioral intervention or one of the two information groups . Because the aim was to prevent long-term disability , the key outcome variables at the 1-year follow-up assessment were sick absenteeism and health care use . Other variables were pain , function , fear-avoidance beliefs , and cognitions . Results . The comparison groups reported benefits . However , the risk for a long-term sick absence developing was lowered ninefold for the cognitive-behavior intervention group as compared with the risk for the information groups ( relative risk , 9.3 ) . Participants in the cognitive-behavior group also reported a significant decrease in perceived risk . In addition , the cognitive-behavior group demonstrated a significant decrease in physician and physical therapy use as compared with two groups receiving information , in which such use increased . All three groups tended to improve on the variables of pain , fear-avoidance , and cognitions . Conclusions . This study demonstrates that a cognitive-behavior group intervention can lower the risk of a long-term disability developing . These findings underscore the significance of early interventions that specifically aim to prevent chronic problems . This approach might be applied to primary care setting Objective : This article examines the effectiveness of manual therapy with specific adjuvant exercise for treating chronic low back pain and disability . Methods : A single blind , r and omized , controlled trial was employed . Patients were prescribed an exercise program that was tailored to treat their musculoskeletal dysfunctions or given a nonspecific program of general stretching and aerobic conditioning . In addition , patients received manual therapy or sham manual therapy . Participants were seen for 6 weekly sessions and were asked to perform their exercise program twice daily . Results : Seventy-two out of 100 patients completed the study . Multivariate tests conducted for measures of pain and disability revealed a significant group by time interaction ( P = 0.04 and P = 0.05 , respectively ) , indicating differential change in these measures pretreatment to posttreatment as a function of the treatment received . When controlling for pretreatment scores , patients receiving manual therapy with specific adjuvant exercise reported significant reductions in pain . No change in perceived disability was observed , with the exception that patients receiving sham manual therapy with specific adjuvant exercise reported significantly greater disability at posttreatment . Discussion : Manual therapy with specific adjuvant exercise appears to be beneficial in treating chronic low back pain . Despite changes in pain , perceived function did not improve . It is possible that impacting chronic low back pain alone does not address psychosocial or other factors that may contribute to disability . Further studies are needed to examine the long-term effects of these interventions and to address what adjuncts are beneficial in improving function in this population
Output:
| Conclusions The clinical course of LBP symptoms followed a pattern that was similar in RCTs and cohort observational studies . |
MS213256 | ***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: INTRODUCTION cardiac resynchronization therapy ( CRT ) may improve prognosis in patients with chronic right ventricular ( RV ) pacing , and optimal lead position can decrease nonresponders . We evaluated the clinical and echocardiographic response to CRT in patients with previous chronic RV pacing , using pressure-volume loop analyses to determine the optimal left ventricular ( LV ) lead position during implantation . METHODS AND RESULTS In this single-blinded , r and omized , controlled crossover study , 40 patients with chronic RV apical pacing and symptoms of heart failure , decreased LV ejection fraction ( LVEF ) or dyssynchrony were included . During implantation , stroke work ( SW ) , LVEF , cardiac output , and LV dP/dt(max ) were assessed by a conductance catheter . Clinical and echocardiographic response was studied during a 3-month period of RV pacing ( RV period , LV lead inactive ) and a 3-month period of biventricular pacing ( CRT period ) . At the optimal LV lead position , SW ( 37 ± 41 % ) , LVEF ( 16 ± 13 % ) , cardiac output ( 29 ± 16 % ) , and LV dP/dt(max ) increased ( 11 ± 11 % ) significantly during biventricular pacing compared to baseline . Additional benefit could be achieved by pressure-volume loop guided selection of the best left-sided pacing location . RV outflow tract pacing did not improve hemodynamics . During follow-up , symptoms improved during CRT , VO(2,max ) increased 10 % and significant improvements in LVEF , LV volumes , and mitral regurgitation were observed as compared to the RV period . CONCLUSIONS CRT in patients with chronic RV pacing causes significant improvement of both LV function as measured by pressure-volume loops during implantation and clinical and echocardiographic improvement during follow-up . Pressure-volume loops during implantation may facilitate selection of the most optimal pacing site AIMS To investigate whether cardiac resynchronization therapy ( CRT ) by means of biventricular ( BiV ) pacing can improve left ventricular ( LV ) function , remodelling and clinical status in chronically right ventricular ( RV ) paced patients with mild cardiomyopathy . METHODS AND RESULTS Thirty-six chronically ( 10 + /- 7 years ) RV paced patients with left ventricular ejection fraction ( LVEF ) < 40 % or LVEDD > 55 mm , without an established indication for CRT , were subjected to 6 months RV and BiV pacing in a patient-blinded , r and omized crossover design . Treatment-effects of BiV pacing were evaluated for LV function , LV remodelling and clinical status . As compared with RV pacing , BiV pacing significantly improved LV function ( LVEF 46 + /- 12 vs. 39 + /- 12 % and LVFS 24 + /- 7 vs. 21 + /- 7 % ) and reduced LV end-diastolic and end-systolic diameters and volumes ( LVEDD 56 + /- 8 vs. 59 + /- 8 mm , LVESD 43 + /- 8 vs. 47 + /- 9 mm , LVEDV 132 + /- 65 vs.144 + /- 62 mL and LVESV 77 + /- 56 vs. 92 + /- 55 mL , respectively ) . In 19 patients ( 53 % ) response to BiV pacing was clinical ly relevant , defined as LVESV reduction > 15 % . BiV pacing also significantly improved NYHA classification . CONCLUSION BiV pacing following chronic RV pacing may improve LV function and reverse LV remodelling in patients with relatively mild LV dysfunction or remodelling . Hence , up grade to BiV pacing might be considered in chronically RV paced patients with mild cardiomyopathy Background — Benefits of cardiac resynchronization therapy ( CRT ) on morbidity and mortality in selected patients are well known . Although the number of up grade procedures from single- or dual-chamber devices to CRT is increasing , there are only sparse data on the outcomes of up grade procedures compared with de novo CRT . This study aim ed to evaluate clinical response and survival in patients receiving de novo versus up grade CRT defibrillator therapy . Methods and Results — Prospect ively collected outcome data were compared in patients undergoing de novo or up grade CRT defibrillator implantation at 3 implant centers in Germany and Hungary . Clinical response was defined as an improvement by at least one New York Heart Association ( NYHA ) functional class . CRT implantation was performed in 552 consecutive patients of whom 375 underwent a de novo and 177 an up grade procedure . Up grade patients were more often implanted for secondary prevention , suffered more often from atrial fibrillation , chronic kidney disease , diabetes mellitus , and dyslipidemia , and had more often a non-LBBB ( left bundle branch block ) wide QRS complex , and lower left ventricular ejection fraction . Up grade procedures were associated with a lower response rate compared to the de novo group ( 57 % versus 69 % , P univariate=0.008 , P multivariate=0.021 ) . During the follow-up of 37±28 months , survival was worse after up grade compared with de novo CRT defibrillator implantations ( hazard ratio , 1.65 ; 95 % confidence interval , 1.22–2.24 ; P=0.001 ) even after careful adjustment for important baseline variables ( adjusted hazard ratio , 1.68 ; 95 % confidence interval , 1.20–2.34 ; P=0.002 ) and after propensity-score matching ( propensity-adjusted hazard ratio , 1.79 ; 95 % confidence interval , 1.08–2.95 ; P=0.023 ) . Conclusions — Both clinical response and long-term survival were less favorable in patients undergoing CRT up grade compared to de novo implantations BACKGROUND Observational studies suggest that conventional right ventricular apical pacing may have a deleterious effect on left ventricular function . In this study , we examined whether biventricular pacing is superior to right ventricular apical pacing in preventing deterioration of left ventricular systolic function and cardiac remodeling in patients with bradycardia and a normal ejection fraction . METHODS In this prospect i ve , double-blind , multicenter study , we r and omly assigned 177 patients in whom a biventricular pacemaker had been successfully implanted to receive biventricular pacing ( 89 patients ) or right ventricular apical pacing ( 88 patients ) . The primary end points were the left ventricular ejection fraction and left ventricular end-systolic volume at 12 months . RESULTS At 12 months , the mean left ventricular ejection fraction was significantly lower in the right-ventricular-pacing group than in the biventricular-pacing group ( 54.8+/-9.1 % vs. 62.2+/-7.0 % , P<0.001 ) , with an absolute difference of 7.4 percentage points , whereas the left ventricular end-systolic volume was significantly higher in the right-ventricular-pacing group than in the biventricular-pacing group ( 35.7+/-16.3 ml vs. 27.6+/-10.4 ml , P<0.001 ) , with a relative difference between the groups in the change from baseline of 25 % ( P<0.001 ) . The deleterious effect of right ventricular apical pacing occurred in prespecified subgroups , including patients with and patients without preexisting left ventricular diastolic dysfunction . Eight patients in the right-ventricular-pacing group ( 9 % ) and one in the biventricular-pacing group ( 1 % ) had ejection fractions of less than 45 % ( P=0.02 ) . There was one death in the right-ventricular-pacing group , and six patients in the right-ventricular-pacing group and five in the biventricular-pacing group were hospitalized for heart failure ( P=0.74 ) . CONCLUSIONS In patients with normal systolic function , conventional right ventricular apical pacing result ed in adverse left ventricular remodeling and in a reduction in the left ventricular ejection fraction ; these effects were prevented by biventricular pacing . ( Centre for Clinical Trials number , CUHK_CCT00037 . Abstract Aims There is lack of conclusive evidence from r and omized clinical trials on the efficacy and safety of up grade to cardiac resynchronization therapy ( CRT ) in patients with implanted pacemakers ( PM ) or defibrillators ( ICD ) with reduced left ventricular ejection fraction ( LVEF ) and chronic heart failure ( HF ) . The BUDAPEST-CRT Up grade Study was design ed to compare the efficacy and safety of CRT up grade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular ( RV ) septal/apical pacing , reduced LVEF , and symptomatic HF . Methods and results The BUDAPEST-CRT study is a prospect i ve , r and omized , multicentre , investigator-sponsored clinical trial . A total of 360 subjects will be enrolled with LVEF ≤ 35 % , NYHA functional classes II – IVa , paced QRS ≥ 150 ms , and a RV pacing ≥ 20 % . Patients will be followed for 12 months . R and omization is performed in a 3:2 ratio ( CRT-D vs. ICD ) . The primary composite endpoint is all-cause mortality , a first HF event , or less than 15 % reduction in left ventricular ( LV ) end-systolic volume at 12 months . Secondary endpoints are all-cause mortality , all-cause mortality or HF event , and LV volume reduction at 12 months . Tertiary endpoints include changes in quality of life , NYHA functional class , 6 min walk test , natriuretic peptides , and safety outcomes . Conclusion The results of our prospect i ve , r and omized , multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator ( CRT-D ) up grade in patients with symptomatic HF , reduced LVEF , and wide-paced QRS with intermittent or permanent RV pacing . Clinical trials.gov identifier NCT02270840 BACKGROUND The current guidelines do not clearly state when we should up grade a patient with right ventricular pacing ( RVP ) to cardiac resynchronization therapy ( CRT ) , although the deleterious effect of chronic RVP has been established with recent trials . OBJECTIVES The aims of this study were to compare the long-term survival after CRT in patients up grade d from RVP with that in patients with left bundle branch block ( LBBB ) with QRS duration ≥ 150 ms and to compare the mechanical properties associated with CRT response in these groups . METHODS Overall , 135 patients with implanted CRT from a single center ( 85 ( 63 % ) with native wide LBBB and 50 ( 37 % ) with RVP ) were studied prospect ively . Baseline left ventricular typical contraction pattern was determined using speckle tracking echocardiography in the apical 4-chamber view . The predefined end point was death , heart transplantation , or left ventricular assist device implantation over a period of 4 years . RESULTS Patients with RVP had a significantly favorable long-term outcomes with adjusted hazard ratio of 0.36 ( 95 % confidence interval 0.14 - 0.96 ; P = .04 ) . Both groups had ~70 % of patients with typical contraction pattern . The absence of typical contraction pattern was associated with a higher risk of an end point with adjusted hazard ratio of 5.43 ( 95 % confidence interval 2.31 - 12.72 ; P < .001 ) . In patients with typical contraction pattern , activation of the apical septal segment occurred more frequently in the RVP group and of the base or mid septal segments in the LBBB group . CONCLUSION Patients with HF up grade d from RVP have more favorable long-term outcomes after CRT than do native LBBB patients with QRS duration ≥ 150 ms . Contraction pattern assessment can be used to identify potential responders in the RVP group Background Dual‐chamber ( DDDR ) pacing preserves AV synchrony and may reduce heart failure ( HF ) and atrial fibrillation ( AF ) compared with ventricular ( VVIR ) pacing in sinus node dysfunction ( SND ) . However , DDDR pacing often results in prolonged QRS duration s ( QRSd ) as the result of right ventricular stimulation , and ventricular desynchronization may result . The effect of pacing‐induced ventricular desynchronization in patients with normal baseline QRSd is unknown . Methods and Results Baseline QRSd was obtained from 12‐lead ECGs before pacemaker implantation in MOST , a 2010‐patient , 6‐year , r and omized trial of DDDR versus VVIR pacing in SND . Cumulative percent ventricular paced ( Cum%VP ) was determined from stored pacemaker data . Baseline QRSd < 120 ms was observed in 1339 patients ( 707 DDDR , 632 VVIR ) . Cum%VP was greater in DDDR versus VVIR ( 90 % versus
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| Our systematic review and meta- analysis of currently available studies reports that CRT up grade is associated with similar risk for all-cause mortality compared to de novo resynchronization therapy .
Benefits on reverse remodelling and functional capacity improved similarly in both groups suggesting that CRT up grade may be safely and effectively offered in routine practice . |
MS213257 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Background — The benefits of medication adherence to control cardiovascular disease ( CVD ) are well defined , yet multiple studies have identified poor adherence . The influence of life chaos on medication adherence is unknown . Because this is a novel application of an instrument , our preliminary objective was to underst and patient factors associated with chaos . The main objective was to evaluate the extent to which an instrument design ed to measure life chaos is associated with CVD-medication nonadherence . Methods and Results — Using baseline data from an ongoing r and omized trial to improve postmyocardial infa rct ion ( MI ) management , multivariable logistic regression identified the association between life chaos and CVD-medication nonadherence . Patients had hypertension and a myocardial infa rct ion in the past 3 years ( n=406 ) . Nearly 43 % reported CVD-medication nonadherence in the past month . In simple linear regression , the following were associated with higher life chaos : medication nonadherence ( & bgr;=1.86 ; 95 % confidence interval [ CI ] , 0.96–2.76 ) , female sex ( & bgr;=1.22 ; 95 % CI [ 0.22–2.24 ] ) , minority race ( & bgr;=1.72 ; 95 % CI [ 0.78–2.66 ] ) , having less than high school education ( & bgr;=2.05 ; 95 % CI [ 0.71–3.39 ] ) , low health literacy ( & bgr;=2.06 ; 95 % CI [ 0.86–3.26 ] ) , and inadequate financial status ( & bgr;=1.93 ; 95 % CI [ 0.87–3.00 ] ) . Being married ( & bgr;=−2.09 , 95 % CI [ −3.03 to −1.15 ] ) was associated with lower life chaos . As chaos quartile increased , patients exhibited more nonadherence . In logistic regression , adjusting for sex , race , marital status , employment , education , health literacy , and financial status , a 1-unit life chaos increase was associated with a 7 % increase ( odds ratio , 1.07 ; 95 % CI [ 1.02–1.12 ] ) in odds of reporting medication nonadherence . Conclusions — Our results suggest that life chaos may be an important determinant of medication adherence . Life chaos screenings could identify those at risk for nonadherence . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : Background Adherence to evidence based medicines in patients who have experienced a myocardial infa rct ion remains low . Individual ’s beliefs towards their medicines are a strong predictor of adherence and may influence other factors that impact on adherence . Objective To investigate if community pharmacists discussing patients ’ beliefs about their medicines improved medication adherence at 12 months post myocardial infa rct ion . Setting This study included 200 patients discharged from a public teaching hospital in Queensl and , Australia , following a myocardial infa rct ion . Patients were r and omised into intervention ( n = 100 ) and control groups ( n = 100 ) and followed for 12 months . Method All patients were interviewed between 5 to 6 weeks , at 6 and 12 months post discharge by the research er using the repertory grid technique . This technique was used to elicit the patient ’s individualised beliefs about their medicines for their myocardial infa rct ion . In the intervention group , patients ’ beliefs about their medicines were communicated by the research er to their community pharmacist . The pharmacist used this information to tailor their discussion with the patient about their medication beliefs at design ated time points ( 3 and 6 months post discharge ) . The control group was provided with usual care . Main outcome measure The difference in non-adherence measured using a medication possession ratio between the intervention and control groups at 12 months post myocardial infa rct ion . Results There were 137 patients remaining in the study ( intervention group n = 72 , control group n = 65 ) at 12 months . In the intervention group 29 % ( n = 20 ) of patients were non-adherent compared to 25 % ( n = 16 ) of patients in control group . Conclusion Discussing patients ’ beliefs about their medicines for their myocardial infa rct ion did not improve medication adherence . Further research on patients beliefs should focus on targeting non-adherent patients whose reasons for their non-adherence is driven by their medication beliefs Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items BACKGROUND Adherence to evidence -based cardiovascular ( CV ) medications after an acute myocardial infa rct ion ( MI ) is low after the first 6 months . The use of fixed-dose combinations ( FDC ) has been shown to improve treatment adherence and risk factor control . However , no previous r and omized trial has analyzed the impact of a polypill strategy on adherence in post-MI patients . OBJECTIVES The cross-sectional FOCUS ( Fixed-Dose Combination Drug for Secondary Cardiovascular Prevention ) study ( Phase 1 ) aim ed to eluci date factors that interfere with appropriate adherence to CV medications for secondary prevention after an acute MI . Additionally , 6
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| There was some evidence that psychosocial factors , particularly depression , were associated with medication adherence following ACS . |
MS213258 | ***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: This study evaluated the cost effectiveness of bortezomib in relapsed , refractory myeloma , relative to best supportive care ( BSC ) and thalidomide . Data were derived from the phase 2 pivotal study of bortezomib , a Delphi panel of six myeloma thought leaders , and published literature . Objective assumptions regarding treatment choices and consequences ( response and complications ) , and actual cost data were used . Bortezomib was found to be cost effective relative to BSC and thalidomide . Sensitivity analyses demonstrated the robustness of the results . These data suggest that bortezomib provides a cost-effective treatment option and the best value ( in terms of cost/life-yr gained ) among the currently available therapeutic options for relapsed , refractory myeloma BACKGROUND In multiple myeloma , combination chemotherapy with melphalan plus prednisone is still regarded as the st and ard of care in elderly patients . We assessed whether the addition of thalidomide to this combination , or reduced-intensity stem cell transplantation , would improve survival . METHODS Between May 22 , 2000 , and Aug 8 , 2005 , 447 previously untreated patients with multiple myeloma , who were aged between 65 and 75 years , were r and omly assigned to receive either melphalan and prednisone ( MP ; n=196 ) , melphalan and prednisone plus thalidomide ( MPT ; n=125 ) , or reduced-intensity stem cell transplantation using melphalan 100 mg/m2 ( MEL100 ; n=126 ) . The primary endpoint was overall survival . Analysis was by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00367185 . FINDINGS After a median follow-up of 51.5 months ( IQR 34.4 - 63.2 ) , median overall survival times were 33.2 months ( 13.8 - 54.8 ) for MP , 51.6 months ( 26.6-not reached ) for MPT , and 38.3 months ( 13.0 - 61.6 ) for MEL100 . The MPT regimen was associated with a significantly better overall survival than was the MP regimen ( hazard ratio 0.59 , 95 % CI 0.46 - 0.81 , p=0.0006 ) or MEL100 regimen ( 0.69 , 0.49 - 0.96 , p=0.027 ) . No difference was seen for MEL100 versus MP ( 0.86 , 0.65 - 1.15 , p=0.32 ) . INTERPRETATION The results of our trial provide strong evidence to indicate that the use of thalidomide in combination with melphalan and prednisone should , at present , be the reference treatment for previously untreated elderly patients with multiple myeloma BACKGROUND Since 1960 , oral melphalan and prednisone ( MP ) has been regarded as the st and ard of care in elderly multiple myeloma patients . This multicentre r and omised trial compared oral MP plus thalidomide ( MPT ) with MP alone in patients aged 60 - 85 years . METHODS Patients with newly diagnosed multiple myeloma were r and omly assigned to receive oral MP for six 4-week cycles plus thalidomide ( n=129 ; 100 mg per day continuously until any sign of relapse or progressive disease ) or MP alone ( n=126 ) . Analysis was intention-to-treat . This study is registered at , number NCT00232934 . RESULTS Patients treated with thalidomide had higher response rates and longer event-free survival ( primary endpoints ) than patients who were not . Combined complete or partial response rates were 76.0 % for MPT and 47.6 % for MP alone ( absolute difference 28.3 % , 95 % CI 16.5 - 39.1 ) , and the near-complete or complete response rates were 27.9 % and 7.2 % , respectively . 2-year event-free survival rates were 54 % for MPT and 27 % for MP ( hazard ratio [ HR ] for MPT 0.51 , 95 % CI 0.35 - 0.75 , p=0.0006 ) . 3-year survival rates were 80 % for MPT and 64 % for MP ( HR for MPT 0.68 , 95 % CI 0.38 - 1.22 , p=0.19 ) . Rates of grade 3 or 4 adverse events were 48 % in MPT patients and 25 % in MP patients ( p=0.0002 ) . Introduction of enoxaparin prophylaxis reduced rate of thromboembolism from 20 % to 3 % ( p=0.005 ) . CONCLUSION Oral MPT is an effective first-line treatment for elderly patients with multiple myeloma . Anticoagulant prophylaxis reduces frequency of thrombosis . Longer follow-up is needed to assess effect on overall survival Health‐related quality of life ( HRQL ) was prospect ively measured during the phase III APEX trial of bortezomib versus dexamethasone in relapsed multiple myeloma patients . The European Organisation for Research and Treatment of Cancer ( EORTC ) Quality of Life Question naire – Core ( QLQ‐C30 ) and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity ( NTX ) side‐effects question naires were administered at baseline and every 6 weeks up to 42 weeks . Patients receiving bortezomib ( 1·3 mg/m2 , days 1 , 4 , 8 and 11 for eight 3‐week cycles , then days 1 , 8 , 15 and 22 for three 5‐week cycles ; n = 296 ) demonstrated significantly better mean Global Health Status over the study versus patients receiving dexamethasone ( 40 mg/d , days 1–4 , 9–12 , and 17–20 for four 5‐week cycles , then days 1–4 only for five 4‐week cycles ; n = 302 ) , plus significantly better physical health , role , cognitive , and emotional functioning scores , lower dyspnoea and sleep symptom scores , and better NTX question naire score , using multiple imputation to account for missing data . Results were similar using available‐ data analyses . Sensitivity analyses suggested that improved HRQL with bortezomib is at least partially explained by improved survival . These results show that bortezomib was associated with significantly better multidimensional HRQL compared with dexamethasone , consistent with the better clinical outcomes seen with bortezomib OBJECTIVES To investigate the subjective well-being of patients with newly diagnosed multiple myeloma who were treated in a t and em transplantation programme . METHODS Fifty-one patients participated in the prospect i ve , longitudinal question naire study . The EORTC QLQ-C30 and the EuroQol-5D were administered 2 wk after completion of vincristine , adriamycin and dexamethason/vincristine , adriamycin and methyl prednison ( VAD/VAMP ) chemotherapy , both at hospital discharge after treatment with high-dose melphalan ( HDM ) and 1 month after this hospital discharge , at hospital admission , at the day of hospital discharge for peripheral stem cell transplantation ( PSCT ) and at 6 and 12 months following discharge after PSCT . RESULTS Overall , patients ' functioning improved during treatment and follow-up , with significant decreases shortly following PSCT . Shortly after HDM and PSCT , patients reported a considerable increase in levels of soreness in the mouth ( + 26/+36 points on a scale ranging form 0 to 100 ; P < 0.01 ) , change of taste ( + 23/+21 points ; P < 0.05/NS ) , nausea/vomiting ( + 26/+27 points ; P < 0.01/ < 0.05 ) , appetite loss ( + 40/+43 points ; P < 0.001 ) and diarrhoea ( + 25/+36 points ; P < 0.01 ) . However , none of these symptoms persisted during follow-up . CONCLUSION The intensive treatment programme was subjectively being well tolerated by the majority of patients . The duration of declined quality of life after administration of HDM seemed to be short . The duration of subjective recovery after PSCT remained uncertain , but in any case was present at the 6 month follow-up . Together with the rather good results in survival , the evaluation of quality of life invites further exploration of double transplantations in multiple myeloma OBJECTIVE To study the clinical course of patients with multiple myeloma ( MM ) that relapses after initial therapy . PATIENTS AND METHODS Patients with MM , seen at the Mayo Clinic in Rochester , Minn , between January 1 , 1985 , and December 31 , 1998 , were identified from a prospect ively maintained data base . Our study population consisted of 578 patients with newly diagnosed MM who were followed up and monitored throughout their clinical course at our institution . RESULTS The median age of the 578 patients with MM was 65 years ( range , 26 - 92 years ) ; 228 patients ( 39 % ) were women . The median follow-up of 71 surviving patients was 55 months ( range , 0 - 202 months ) . The overall survival ( OS ) for the 578 patients at 1 , 2 , and 5 years was 72 % , 55 % , and 22 % , respectively ; the median OS from initial therapy was 28.4 months . The median OS of 355 patients who experienced relapse after initial treatment was 17.1 months from initiation of the second therapy , and 84 % died within 5 years . The duration of response decreased consistently with each successive regimen . Patients with a high plasma cell labeling index ( > or = 1.0 % ) , low platelet count ( < 150 x 10(9)/L ) , high creatinine level ( > or = 2.0 mg/dL ) , and low albumin level ( < 3.0 g/dL ) had a poorer prognosis . CONCLUSIONS Our study revealed decreasing response duration with increasing number of salvage regimens , probably reflecting acquired drug resistance and an increasing proliferative rate of the myeloma cells . Patients who experienced relapse after initial treatment and received salvage therapy had a median survival of nearly 1.5 years . This must be remembered when making treatment decisions for these patients and must be factored in when assessing the efficacy of new therapies In a population -based study , the Nordic Myeloma Study Group found a survival advantage for high-dose melphalan with autologous blood stem-cell support compared to conventional chemotherapy in myeloma patients under 60 yr of age ( risk ratio : 1.62 ; confidence interval [ CI ] 1.22–2.15 ; p=0.001 ) . A study of health-related quality of life ( HRQoL ) was integrated in the trial , using the EORTC QLQ-C30 question naire . Of the 274 patients receiving intensive therapy 221 ( 81 % ) were compared to 113 ( 94 % ) of 120 patients receiving conventional melphalan-prednisone treatment . Prior to treatment , there were no statistically significant differences in any HRQoL score between the two groups . One month after the start of induction chemotherapy , the patients on intensive treatment had more sleep disturbance than the control patients . At 6 mo , corresponding to a mean of 52 d after high-dose melphalan , the patients on intensive treatment had moderately lower scores for global QoL and role and social functioning and there was also a significantly higher score for appetite loss . At 12 and 24 mo , the HRQoL was similar to that of the control patients . At 36 mo , there was a trend toward less fatigue , pain , nausea , and appetite loss in the intensive-treatment group . Thus , the 18 mo of prolonged survival seem to be associated with a good health-related quality of life . Despite the moderate HRQoL reduction associated with the early intensive chemotherapy phase , this treatment modality must be regarded as an important step forward in the care of multiple myeloma A prospect i ve r and omised phase III study in patients < or = 65 years old with previously untreated multiple myeloma ( MM ) , intensive chemotherapy followed by myeloablative chemotherapy and autologous stem-cell rescue was compared with intensive chemotherapy alone . This economic evaluation was based on detailed data from patient charts and hospital information systems . In the intention-to-treat analysis , mean total treatment and follow-up costs of the myeloablative treatment arm were 81,643 euros compared to 68,802 euros for the chemotherapy arm ( P=0.09 ) . Costs per quality -adjusted life year were 51,357 euros versus 37,328 euros . In the clinical study , no significant differences were found in overall survival after a median follow-up of 33 months from r and omisation . Intensive chemotherapy is regarded as st and ard therapy for younger patients with previously untreated MM . Cost-effectiveness of myeloma therapy after 3 years of follow up seems not to be favoured by myeloablative treatment with autologous stem-cell rescue High-dose melphalan and autologous hematopoietic stem cell transplantation ( HSCT ) is a st and ard treatment for myeloma , but very little is known about the psychosocial or quality -of-life difficulties that these patients encounter during treatment . Data regarding older
Output:
| The review found that VMP and MPT can both be considered more clinical ly effective than MP for the first-line treatment of MM in people for whom high-dose therapy and SCT would not be appropriate .
CTDa was more effective than MP in terms of complete response but data on survival outcomes did not meet the inclusion criteria .
Cost-effectiveness analysis indicated that MPT has a greater probability of being cost-effective than either VMP or CTDa .
CONCLUSIONS Service provision is unlikely to change greatly . |
MS213259 | ***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 C-reactive protein ( CRP ) , intercellular adhesion molecule-1 ( ICAM-1 ) , vascular cell adhesion molecule-1 ( VCAM-1 ) , and E-selectin are systemic inflammatory markers ( IM ) that positively correlate with cardiovascular ( CV ) risk . Despite the known CV effects of atypical antipsychotics , there is limited prospect i ve data on IM changes during treatment . METHODS The IM outcomes were compared between antipsychotic treatment groups in the CATIE ( Clinical Antipsychotic Trials of Intervention Effectiveness ) schizophrenia trial phase 1 with subjects with laboratory assessment s at baseline and 3 months ( n = 789 ) . RESULTS There were significant treatment differences in CRP , E-selectin , and ICAM-1 at 3 months , with a differential impact of baseline values on the CRP and ICAM-1 results . In overall comparisons , quetiapine and olanzapine had the highest median levels for CRP , and olanzapine for E-selectin and ICAM-1 . Olanzapine was significantly different after baseline adjustment than perphenazine ( p = .001 ) for E-selectin , and in those with low baseline CRP ( < 1 mg/L ) , olanzapine was significantly different than perphenazine ( p < .001 ) , risperidone ( p < .001 ) , and ziprasidone ( p = .002 ) for CRP . Perphenazine had the lowest 3-month ICAM-1 levels in subjects with baseline ICAM-1 above the median , but the differences were not statistically significant versus olanzapine ( p = .010 ) , quetiapine ( p = .010 ) , and risperidone ( p = .006 ) after controlling for multiple comparisons . The 18-month repeated measures CRP analysis confirmed the significantly higher values for olanzapine in those with low baseline CRP . CONCLUSIONS This analysis provides further evidence for differential antipsychotic metabolic liabilities as measured by changes in systemic inflammation . C-reactive protein might emerge as a useful target for CV risk outcomes in schizophrenia patients Few pharmacological intervention studies have examined the impact of medication on social cognition , particularly emotion perception . The goal of this r and omized , double-blind study is to compare the effects of several second generation antipsychotics and a first generation antipsychotic , perphenazine , on emotion perception in individuals with schizophrenia . Patients were assigned to receive treatment with olanzapine , queitapine fumarate , risperidone , ziprasidone or perphenazine for up to 18 months . Eight hundred and seventy three patients completed an emotion perception test immediately prior to r and omization and after 2 months of treatment . We also examined baseline predictors of emotion perception change . Most treatments were associated with a small , non-statistically significant improvement in emotion perception at two months , although they did not differ from one another . Greater improvement in emotion perception at 2 months was significantly predicted by lower baseline emotion perception and higher baseline neurocognitive functioning , and marginally predicted by less time on an antipsychotic BACKGROUND One of the major challenges in the design of double-blind flexible-dosing clinical trials comparing active drugs is the selection of dosing regimens that are equivalent across drugs . This study uses data from the CATIE schizophrenia trial to evaluate the hypothesis that drugs that were dosed somewhat higher in the trial than in typical practice would show greater efficacy and more side effects , especially at high capsule levels , than drugs that were dosed at lower relative strengths . METHODS CATIE was a large ( N=1460 ) r and omized trial comparing 5 antipsychotics in patients with chronic schizophrenia . The blind was maintained in CATIE by prescribing identical-looking capsules of each medication . Dosing was flexible , such that PIs could prescribe from one to four capsules per day , and could modify the dose based on a patient 's symptoms and side effects . Capsule strengths for olanzapine ( 7.5 mg ) and quetiapine ( 200 mg ) were relatively higher than for risperidone ( 1.5 mg ) , perphenazine ( 8 mg ) or ziprasidone ( 40 mg ) . Proportional hazards models of time to all cause discontinuation and mixed regression models for continuous measures of symptoms , quality of life and side effects were used to test for interactions between r and omly assigned drug and number of capsules prescribed per visit . We hypothesized that if a dosing bias was present , the flex-dosing design would result in a significant interaction such that drugs with higher relative dosing per capsule would be more effective and have more side effects than drugs with lower relative dosing and that this effect would be greatest at the largest prescribed dosing regimen ( 4 capsules ) . RESULTS There were no significant interactions between drug assignment and number of capsules in the proportional hazards analyses of time to all cause discontinuation ( p=.77 , excluding ziprasidone and .74 in the ziprasidone cohort ) or in the mixed model analysis of PANSS symptoms ( p=.49 ) , quality of life ( p=.45 ) ; or measures of tardive dyskinesia ( AIMS , p=.47 ) . However a significant interaction was observed on the Barnes akathisia scale ( p=.0005 ) , on the Simpson Angus EPS scale ( p=.10 ) and on the analysis of weight ( p=0.014 ) . Paired comparisons did not show the hypothesized pattern of relationships for akathisia or EPS , but such a pattern was suggested for olanzapine in the analysis of weight although it emerged at 2 , 3 and 4 capsules indicating a general drug effect rather than a relative dosing difference . CONCLUSION Dosing biases do not seem to have affected the results of the CATIE trial We compared the efficacy and safety of ziprasidone and aripiprazole in the treatment of acutely ill patients with schizophrenia . Patients were r and omized to receive double-blind treatment with ziprasidone ( 80–160 mg/day ) , or aripiprazole ( 10–30 mg/day ) for up to 4 weeks . Primary efficacy measures were the Clinical Global Impression of Severity scale ( CGI-S ) and Brief Psychiatric Rating Scale ( BPRSd ) total ( derived from the Positive and Negative Syndrome Scale ) . Noninferiority for ziprasidone ( N=125 ) relative to aripiprazole ( N=128 ) was established for CGI-S score ( P=0.007 ) , but was not confirmed for BPRSd total score ( P=0.248 ) . Effect sizes for within-group improvement , however , were robust for both ziprasidone and aripiprazole ( effect size range 1.0–1.1 for CGI-S ; and range 1.1–1.2 for BPRSd total ) . A mixed model repeated measures analysis of BPRSd total score favored ziprasidone at day 4 compared with aripiprazole ( P=0.04 ) , with no significant differences between treatment groups at other visits ( P=0.001 for interaction between treatment and visit ) . No statistically significant difference was found in CGI-S score between groups across all visits . Our findings suggest that ziprasidone and aripiprazole exhibit similar efficacy and tolerability profiles in the treatment of acute schizophrenia . Differences between the two drugs in the onset of therapeutic effect warrant further investigation This 18-week , r and omized , flexible-dose , double-blind , double-dummy trial evaluated ziprasidone as an alternative to clozapine in treatment-refractory schizophrenia patients . Patients had a DSM-IV diagnosis of schizophrenia , a history of resistance and /or intolerance to at least three acute cycles with different antipsychotics given at therapeutic doses , PANSS score > or=80 , and CGI-S score > or=4 . Patients were r and omized to ziprasidone ( 80 - 160 mg/day , n=73 ) or clozapine ( 250 - 600 mg/day , n=74 ) . On the primary ITT-LOCF analysis , baseline-to-endpoint decreases in PANSS total scores were similar in the ziprasidone ( -25.0+/-22.0 , 95 % CI -30.2 to -19.8 ) and clozapine ( -24.5+/-22.5 , 95 % CI -29.7 to -19.2 ) groups . A progressive and significant reduction from baseline in PANSS total score was observed from day 11 in both study arms . There were also significant improvements on PANSS subscales , CGI-S , CG-I , CDSS , and GAF , without between-drug differences . The two treatment groups had similar rates of early discontinuations due to AEs . AEs were mostly of similar mild-moderate severity in the two groups . There were also no detrimental effects on prolactin , renal and liver function , hematology , and cardiovascular parameters . However , ziprasidone but not clozapine showed a significant reduction of SAS and AIMS scores . Moreover , when compared with clozapine , ziprasidone also had a more favorable metabolic profile , with significant endpoint differences in weight , fasting glucose , total cholesterol , LDL cholesterol , and triglycerides . In conclusion , this trial indicates that both ziprasidone and clozapine , having comparable efficacy coupled with satisfactory general safety and tolerability , may be regarded as valuable options for the short-term treatment of difficult-to-treat schizophrenia patients with a history of multiple resistance and /or intolerance to antipsychotics . The more favorable metabolic profile of ziprasidone may represent an added value that could guide clinicians , at least in the presence of patients at high risk for metabolic disorders PURPOSE Previous analysis of data from CATIE showed that patients r and omly assigned to switch to a new medication were more likely to discontinue study drug than those who stayed on the medication they had been taking prior to r and omization . This study addresses additional outcomes measures evaluating symptoms , neurocognition , quality of life , neurological side effects , weight , and health costs . First , considering patients r and omized to olanzapine or risperidone , outcomes among patients who had been on the drug to which they were r and omized prior to CATIE ( N=129 " stayers " ) were compared to outcomes of those who switched to either of these two drugs ( N=269 " switchers " ) . A second set of analyses considered patients on baseline monotherapy with olanzapine ( N=297 ) ; risperidone ( N=252 ) or quetiapine ( n=87 ) and compared those r and omly assigned to stay on each of these medications with those assigned to switch to any of the other five phase 1 medications in CATIE . In mixed models of each outcome the independent variable of primary interest represented stay vs. switch , with multivariate adjustment for potential confounding factors . RESULTS With one exception , there were no significant differences between stayers and switchers on any outcome measure in either set of analyses . The exception was that , in the second set of analyses , patients who stayed on olanzapine showed greater weight gain than those who switched from olanzapine to other drugs . CONCLUSION Switching to a new medication yielded no advantage over staying on the previous medication . Staying on olanzapine was associated with greater weight gain OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate BACKGROUND Violence is an uncommon but significant problem associated with schizophrenia . AIMS To compare antipsychotic medications in reducing violence among patients with schizophrenia over 6 months , identify prospect i ve predictors of violence and examine the impact of medication adherence on reduced violence . METHOD Participants ( n=1445 ) were r and om
Output:
| Ziprasidone may be a slightly less efficacious antipsychotic drug than amisulpride , olanzapine and risperidone .
Its main advantage is the low propensity to induce weight gain and associated adverse effects . |
MS213260 | ***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: A prospect i ve study of 50 consecutive children who convulsed in the first 28 days of life is in progress . The surviving children are now aged from four to six years . The incidence of simple hypocalcaemic tetany in these children was low ( 14 per cent ) and its benign outcome has been confirmed . In considering neonatal seizures from other causes , the outcome at age four years is as follows : 26 per cent are dead ; 33 per cent show adverse sequelae ; 5 per cent are of question able status ; and 36 per cent appear to be normal . A wide range of h and icap is present among the sample . Seizures have recurred in 20 per cent of all children surviving the neonatal period OBJECTIVE Our purpose was to compare the predictive value of intrapartum fetal pulse oximetry with that of fetal blood analysis for an abnormal neonatal outcome in case of an abnormal fetal heart rate . STUDY DESIGN A prospect i ve multicenter observational study was conducted from June 1994 to November 1995 . Fetal oxygen saturation was continuously recorded with a Nellcor N-400 fetal pulse oximeter in case of an abnormal fetal heart rate during labor . Simultaneous readings of fetal oxygen saturation and fetal blood analysis obtained before birth ( i.e. , either at full dilatation or before cesarean section when indicated ) were compared with the neonatal status . The criteria for an abnormal neonatal outcome were ( 1 ) an umbilical arterial blood pH < or = 7.15 and ( 2 ) a combined variable including 5-minute Apgar score < or = 7 , umbilical arterial pH < or = 7.15 , secondary respiratory distress , transfer in a neonatal care unit , or neonatal death . RESULTS At a 7.20 threshold for fetal scalp pH and 30 % for fetal oxygen saturation ( i.e. , the 10th percentile in the study population ) , the predictive value of fetal pulse oximetry was similar to that of fetal blood analysis for an arterial umbilical pH < or = 7.15 and for an abnormal neonatal outcome ( positive predictive value 56 % vs 55 % , negative predictive value 81 % vs 82 % , sensitivity 29 % vs 35 % , and specificity 93 % vs 91 % , respectively ) . The receiver-operator characteristic curve showed similar performance of either technique for cutoff values < or = 7.20 for fetal blood pH and < or = 30 % for fetal oxygen saturation , whereas fetal pulse oximetry became superior at higher thresholds . CONCLUSION The predictive value of intrapartum fetal pulse oximetry can be favorably compared with that of fetal blood analysis . R and omized controlled management trials can now be performed to assess potential clinical benefits of this new tool A controlled prospect i ve study of the differential effects of intrapartum fetal monitoring on mothers and infants has been conducted at Denver General Hospital , Denver , Colorado . A total of 690 high-risk obstetric patients in labor were r and omly assigned to one of three monitoring groups -- auscultation , electronic fetal monitoring alone , or electronic monitoring with the option to scalp sample . There were no differences in immediate infant outcomes in any measured category ( Apgar scores , cord blood gases , neonatal death , neonatal morbidity , nursery course ) among the three groups . There were no differences in rates of infant or maternal infections . The cesarean section rate was markedly increased in the electronically monitored groups , especially in the electronically monitored alone ( 18 % ) as compared with the auscultated ( 6 % ) ( P less than 0.005 ) . In this controlled trial electronic monitoring did not improve neonatal outcomes and the mothers were at increased risk of cesarean section In a large r and omized , controlled study of fetal heart rate monitoring with either continuous electronic fetal heart monitoring or auscultation at specified intervals , only one pattern of deviation in the fetal heart rate correlated significantly with neonatal neurologic examinations at 0 to 48 hours and 72 hours to 1 week : late decelerations in stage 1 and in stage 2 . Other variables from labor and delivery , specifically , duration of labor after hospital admission , failure of labor to progress , number of fetal scalp pH values , and presence of meconium were important predictors of neonatal outcome in the regression analyses . The fetal heart rate deviations did contribute significantly to the percent variance accounted for in the regression analyses with neonatal outcomes of Apgar scores at 1 and 5 minutes and serial neonatal neurologic examinations A controlled prospect i ve study of the effects of fetal monitoring on mothers and infants was conducted at Denver General Hospital , Denver , Colorado . A total of 690 high-risk patients in labor were r and omly assigned to one of three groups ; auscultation alone , electronic fetal monitoring and electronic fetal monitoring with the option to obtain a scalp pH sample . Maternal and neonatal infectious morbidity after vaginal or cesarean delivery was unchanged with internal fetal monitoring . Despite frequent antibiotic prophylaxis ( 95 % cesarean section v. 11 % vaginal ) , cesarean section was the most significant factor associated with increased maternal puerperal infectious morbidity ( 13.75 % cesarean section v. 3.9 % vaginal ) . Although hours of labor , hours of rupture of membranes , hours of internal catheter , number of exams and presence of meconium were not associated with increased maternal infection , prolonged hours of internal catheter usage greater than 8 hours and prolonged rupture of membranes greater than 12 hours were associated with increased antibiotic usage in the neonate OBJECTIVE To compare different methods of intrapartum foetal heart rate monitoring in high risk pregnancies in detecting foetal heart rate abnormalities , need for operative delivery for foetal distress , and neonatal mortality and short term neonatal morbidity . DESIGN A prospect i ve r and omised controlled trial . SETTING Women in labour at a referral maternity hospital . PATIENTS Women who were 37 weeks or more pregnant with singleton cephalic presentation and normal foetal heart rate prior to entry into the study . INTERVENTION Women were r and omly allocated using sealed opaque envelopes to either continuous electronic foetal heart rate monitoring or intermittent monitoring using h and held doppler foetal heart rate detector . OUTCOME MEASURES These include abnormal foetal heart rate patterns , need for operative delivery for foetal distress , neonatal mortality , Apgar scores , admission to NNU , neonatal seizures , and hypoxic encephalopathy . RESULTS R and omisation achieved good comparability between the two groups . Abnormal FHR patterns were more frequent in the electronic group ( 54 pc versus 32 pc ) . Caesarean section rate was not significantly different in the two groups ( 28 pc versus 24 pc ) although slightly higher compared to overall for the unit ( 18pc ) . Foetal outcome was also comparable between the two groups . CONCLUSIONS Asphyxia can be detected with a h and held doppler just as reliably as by the use of electronic monitors and their use should be further evaluated and promoted in obstetric units caring for high risk pregnancies in developing countries with scarce re sources Abstract Objective : To compare effectiveness of different methods of monitoring intrapartum fetal heart rate . Design : Prospect i ve r and omised controlled trial . Setting : Referral maternity hospital , Harare , Zimbabwe . Subjects : 1255 women who were 37 weeks or more pregnant with singleton cephalic presentation and normal fetal heart rate before entry into study . Interventions : Intermittent monitoring of fetal heart rate by electronic monitoring , Doppler ultrasound , use of Pinard stethoscope by a research midwife , or routine use of Pinard stethoscope by attending midwife . Main outcome measures - Abnormal fetal heart rate patterns , need for operative delivery for fetal distress , neonatal mortality , Apgar scores , admission to neonatal unit , neonatal seizures , and hypoxic ischaemic encephalopathy . Results : Abnormalities in fetal heart rate were detected in 54 % ( 172/318 ) of the electronic monitoring group , 32 % ( 100/312 ) of the ultrasonography group , 15 % ( 47/310 ) of the Pinard stethoscope group , and 9 % ( 28/315 ) of the routine monitoring group . Caesarean sections were performed for 28 % ( 89 ) , 24 % ( 76 ) , 10 % ( 32 ) , and 15 % ( 46 ) of the four groups respectively . Neonatal outcome was best in the ultrasonography group : hypoxic ischaemic encephalopathy occurred in two , one , seven , and 10 cases in the four groups respectively ; neonatal seizures occurred only in the last two groups ( six and nine cases respectively ) ; and deaths occurred in eight , two , five , and nine cases respectively . Conclusions : Abnormalities in fetal heart rate were more reliably detected by Doppler ultrasonography than with Pinard stethoscope , and its use result ed in good perinatal outcome . The use ofrelatively cheap ultrasound monitors should be further evaluated and promoted in obstetric units caring for high risk pregnancies in developing countries with scarce re sources OBJECTIVE Recent developments permit the use of pulse oximetry to evaluate fetal oxygenation in labor . We tested the hypothesis that the addition of fetal pulse oximetry in the evaluation of abnormal fetal heart rate patterns in labor improves the accuracy of fetal assessment and allows safe reduction of cesarean deliveries performed because of nonreassuring fetal status . STUDY DESIGN A r and omized , controlled trial was conducted concurrently in 9 centers . The patients had term pregnancies and were in active labor when abnormal fetal heart rate patterns developed . The patients were r and omized to electronic fetal heart rate monitoring alone ( control group ) or to the combination of electronic fetal monitoring and continuous fetal pulse oximetry ( study group ) . The primary outcome was a reduction in cesarean deliveries for nonreassuring fetal status as a measure of improved accuracy of assessment of fetal oxygenation . RESULTS A total of 1010 patients were r and omized , 502 to the control group and 508 to the study group . There was a reduction of > 50 % in the number of cesarean deliveries performed because of nonreassuring fetal status in the study group ( study , 4 . 5 % ; vs. control , 10.2 % ; P = .007 ) . However , there was no net difference in overall cesarean delivery rates ( study , n = 147 [ 29 % ] ; vs. control , 130 [ 26 % ] ; P = .49 ) because of an increase in cesarean deliveries performed because of dystocia in the study group . In a blinded partogram analysis 89 % of the study patients and 91 % of the control patients who had a cesarean delivery because of dystocia met defined criteria for actual dystocia . There was no difference between the 2 groups in adverse maternal or neonatal outcomes . In terms of the operative intervention for nonreassuring fetal status , there was an improvement in both the sensitivity and the specificity for the study group compared with the control group for the end points of metabolic acidosis and need for resuscitation . CONCLUSION The study confirmed its primary hypothesis of a safe reduction in cesarean deliveries performed because of nonreassuring fetal status . However , the addition of fetal pulse oximetry did not result in an overall reduction in cesarean deliveries . The increase in cesarean deliveries because of dystocia in the study group did appear to result from a well-documented arrest of labor . Fetal pulse oximetry improved the obstetrician 's ability to more appropriately intervene by cesarean or operative vaginal delivery for fetuses who were actually depressed and acidotic . The unexpected increase in operative delivery for dystocia in the study group is of concern and remains to be explained Objective : The present study was design ed to assess the utility of Doppler velocimetry in the setting of non-reassuring cardiotocography tracings . Methods : Two hundred fifty six women with term singleton pregnancies were enrolled in a controlled trial . Patients received either routine cardiotocograpic ( CTG ) monitoring , or CTG with the addition of Doppler velocimetry in cases of non-reassuring CTG tracings . The results were analyzed according to protocol . Results : In the CTG+Doppler group , there was a trend toward lower risk of neonatal metabolic acidosis than in the CTG group , although the incidence was rare . The CTG+Doppler group had significantly lower rates of cesarean section for fetal distress , and improved neonatal outcomes . Conclusions : We conclude that intrapartum fetal Doppler velocimetry , when combined with CTG , increases the clinicians ’ ability to accurately identify fetal hypoxia , and decreases the rate of Cesarean section In a r and omized controlled trial involving 12,964 women , a policy of continuous electronic intrapartum fetal heart monitoring was compared with an alternative policy of intermittent auscultation , both policies including an option to measure fetal scalp blood pH. Women allocated to electronic fetal heart monitoring had shorter labors and received less analgesia . The caesarean delivery rates were 2.4 % for electronic fetal heart monitoring and 2.2 % for intermittent auscultation but this small difference arose from the identification of nearly twice as many fetuses with low scalp pH ( less than 7.20 ) in the electronic fetal heart monitoring group . The forceps delivery rate was 8.2 % in the electronic fetal heart monitoring group compared with 6.3 % in the intermittent auscultation group , and this excess was explained by more instrumental deliveries prompted by fetal heart rate abnormalities . There were 14 stillbirths and neonatal deaths in each group , with a similar distribution of causes . There
Output:
| CTG during labour is associated with reduced rates of neonatal seizures , but no clear differences in cerebral palsy , infant mortality or other st and ard measures of neonatal wellbeing .
However , continuous CTG was associated with an increase in caesarean sections and instrumental vaginal births .
Research should also address the possible contribution of the supine position to adverse outcomes for babies , and assess whether the use of mobility and positions can further reduce the low incidence of neonatal seizures and improve psychological outcomes for women |
MS213261 | ***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: This study reports the effect of the Fruits and Vegetables Make the Marks intervention , a school-based fruit and vegetable intervention consisting of a home economics classroom component and parental involvement and encouraged participation in the Norwegian School Fruit Programme , all delivered during the school year of 2001 - 02 . Nine r and omly chosen schools received the intervention and 10 schools served as control schools . Participating pupils completed question naires at baseline ( September 2001 ) , at Follow-up 1 ( May-June 2002 ) and at Follow-up 2 ( May 2003 ) . A total of 369 pupils ( 69 % ; mean age , 11.3 years at baseline ) participated in all three surveys . No effect of the intervention was found for intake of fruit and vegetables eaten at school or all day , neither at Follow-up 1 nor at Follow-up 2 . On analysing the effects on potential mediators , significant differences between intervention and control groups were found for Awareness of the five-a-day recommendations only . The intervention programme was rated as very good by the teachers , and the pupils reported that they enjoyed it . However , the intervention failed to change fruit and vegetable intake , probably because it did not succeed in changing the pupils ' preferences for or the accessibility of fruit and vegetables -- the two strongest correlates of children 's fruit and vegetable intake BACKGROUND AND OBJECTIVES With prevalence of childhood obesity increasing rapidly , developing of effective and sustainable intervention strategies is becoming more and more important for the prevention of childhood obesity in China . A trial was developed to evaluate the effect of comprehensive school-based intervention on childhood obesity . METHODS AND STUDY DESIGN A multi-center cluster r and omized controlled trial was conducted among urban children ( n=9,867 ) aged 6 - 13 years in 38 primary schools from six large cities . Comprehensive intervention , nutrition education and physical activity interventions were carried out among children . Nutrition education was also targeted towards teachers , parents and health workers in intervention schools . The program was implemented for 2 semesters from May 2009 to May 2010 . RESULTS The combined prevalence of overweight and obesity increased by 1.5 percent ( 22.7 % vs 24.2 % , p<0.001 ) in control group while 0.2 percent in comprehensive intervention group ( 23.6 % vs 23.8 % , p=0.954 ) after intervention ( p=0.067 ) . The effect was significantly stronger among girls than boys ( -1.4 % vs -0.9 % , p=0.028 ) . A significant intervention effect was found on BMI for -0.3 kg/m2 ( 95 % confidence interval ( CI ) : -0.4 , -0.2 ; p<0.001 ) , BMI z scores for -0.14 ( 95 % CI : -0.18 , -0.11 ; p<0.001)，body fat for -0.8 percent ( 95 % CI : -0.9 , -0.6 ; p<0.001 ) , waist circumference for -0.5 cm ( 95 % CI : -0.6 , -0.3 ; p<0.001 ) , blood serum glucose for -0.20 mmol/L ( 95 % CI : -0.24 , -0.16 ; p<0.001 ) and cholesterol for -0.32 mmol/L ( 95 % CI : -0.34 , -0.30 ; p<0.001 ) . CONCLUSIONS We observed moderately significant effects on combined prevalence of overweight and obesity , BMI , BMI z scores , waist circumference , percentage body fat , glucose and lipid for a comprehensive school-based intervention of childhood obesity in China Background Childhood obesity has been increasing rapidly worldwide . There is limited evidence for effective lifestyle interventions to prevent childhood obesity worldwide , especially in developing countries like China . The objective of this study was to assess the effectiveness of a school-based multi-component lifestyle childhood obesity prevention program ( the CLICK-Obesity study ) in Mainl and China . Methods A cluster r and omized controlled trial was developed among grade 4 students from 8 urban primary schools ( 638 students in intervention , 544 as control ) in Nanjing City , China . Students were r and omly allocated to the control or intervention group at school-level . A one-year multi-component intervention program ( classroom curriculum , school environment support , family involvement and fun programs/events ) together with routine health education was provided to the intervention group , while the control group received routine health education only . The main outcome variables assessed were changes in body mass index , obesity occurrence , obesity-related lifestyle behaviors and knowledge . Results Overall , 1108 ( 93.7 % ) of the 1182 enrolled students completed the intervention study . The intervention group had a larger marginal reduction than did the control group in overall mean BMI value ( -0.32±1.36 vs. -0.29±1.40 , p = 0.09 ) , although this was not significant . Compared with the control group , the intervention group was more likely to decrease their BMI ( OR = 1.44 , 95%CI = 1.10 , 1.87 ) by 0.5 kg/m2 or above , increase the frequency of jogging/running ( OR = 1.55 , 95%CI = 1.18 , 2.02 ) , decrease the frequency of TV/computer use ( OR = 1.41 , 95%CI = 1.09 , 1.84 ) and of red meat consumption ( OR = 1.50 , 95%CI = 1.15 , 1.95 ) , change commuting mode to/from school from sedentary to active mode ( OR = 2.24 , 95%CI = 1.47 , 3.40 ) , and be aware of the harm of selected obesity risk factors . Conclusions The school-based lifestyle intervention program was practical and effective in improving health behaviors and obesity-related knowledge for children in China . This study provides important policy implication s on school-based intervention programs for modifications of obesity-related lifestyles . Trial Registration Chinese Clinical Trial Registry Background Multi-level , longer-term obesity prevention interventions that focus on inequalities are scarce . Fun ‘ n healthy in Morel and ! aim ed to improve child adiposity , school policies and environments , parent engagement , health behaviours and child wellbeing . Methods All children from primary schools in an inner urban , culturally diverse and economically disadvantaged area in Victoria , Australia were eligible for participation . The intervention , fun ‘ n healthy in Morel and ! , used a Health Promoting Schools Framework and provided schools with evidence , school research data and part time support from a Community Development Worker to develop health promoting strategies . Comparison schools continued as normal . Participants were not blinded to intervention status . The primary outcome was change in adiposity . Repeated cross-sectional design with nested longitudinal sub sample . Results Students from twenty-four primary schools ( clusters ) were r and omised ( aged 5–12 years at baseline ) . 1426 students from 12 intervention schools and 1539 students from 10 comparison schools consented to follow up measurements . Despite increased prevalence of healthy weight across all schools , after 3.5 years of intervention there was no statistically significant difference between trial arms in BMI z score post-intervention ( Mean ( sd ) : Intervention 0.68(1.16 ) ; Comparison : 0.72(1.12 ) ; Adjusted mean difference ( AMD ) : -0.05 , CI : -0.19 to 0.08 , p = 0.44 ) . Children from intervention schools consumed more daily fruit serves ( AMD : 0.19 , CI:0.00 to 0.37 , p = 0.10 ) , were more likely to have water ( AOR : 1.71 , CI:1.05 to 2.78 , p = 0.03 ) and vegetables ( AOR : 1.23 , CI : 0.99 to 1.55 , p = 0.07 ) , and less likely to have fruit juice/cordial ( AOR : 0.58 , CI:0.36 to 0.93 , p = 0.02 ) in school lunch compared to children in comparison schools . More intervention schools ( 8/11 ) had healthy eating and physical activity policies compared with comparison schools ( 2/9 ) . Principals and schools highly valued the approach as a catalyst for broader positive school changes . The cost of the intervention per child was $ 65 per year . Conclusion The fun n healthy in Morel and ! intervention did not result in statistically significant differences in BMI z score across trial arms but did result in greater policy implementation , increased parent engagement and re sources , improved child self-rated health , increased fruit , vegetable and water consumption , and reduction in sweet drinks . A longer-term follow up evaluation may be needed to demonstrate whether these changes are sustainable and impact on childhood overweight and obesity . Clinical trial registration ACTRN12607000385448 ( Date su bmi tted 31/05/2007 ; Date registered 23/07/2007 ; Date last up date d 15/12/2009 ) Background Childhood obesity has been a serious public health problem . An effective school-based physical activity ( PA ) intervention is still lacking in China . This study aim ed to assess the effectiveness of a school-based physical activity intervention during 12 weeks on obesity and related health outcomes in school children . Methods It was a non-r and omized controlled trial . Altogether 921 children aged 7 to 15 years were recruited at baseline survey . Children in the intervention group ( n = 388 ) participated in a multi-component physical activity intervention during 12 weeks that included improvement of physical education , extracurricular physical activities for overweight/obese students , physical activities at home , and health education lectures for students and parents . Children ( n = 533 ) in the control group participated in usual practice . Results Participants had mean age of 10.4 years , mean body mass index ( BMI ) of 19.59 kg/m2 , and 36.8 % of them were overweight or obese at baseline survey . The change in BMI in intervention group ( −0.02 ± 0.06 kg/m2 ) was significantly different from that in control group ( 0.41 ± 0.08 kg/m2 ) . The adjusted mean difference was −0.43 kg/m2 ( 95 % CI : −0.63 to −0.23 kg/m2 , P < 0.001 ) . The effects on triceps , subscapular , abdominal skinfold thickness and fasting glucose were also significant in intervention group compared with control group ( all P < 0.05 ) . The change in duration of moderate to vigorous physical activity ( MVPA ) in intervention group ( 8.9 ± 4.3 min/day ) was significantly different from that in control group ( −13.8 ± 3.3 min/day ) . The adjusted mean difference was 22.7 min/day ( 95 % CI : 12.2 to 33.2 min/day , P < 0.001 ) . Conclusions The school-based , multi-component physical activity intervention was effective to decreasing levels of BMI , skinfold thickness , fasting glucose and increasing duration of MVPA . These findings provided evidence for the development of effective and feasible school-based obesity interventions .Trial registration Clinical trials.gov Identifier : NCT02074332 ( 2014 - 02 - 26 The purpose of the study was to investigate the effects of a school-based prevention program on physical activity , fitness , and obesity . We performed a prospect i ve study in eight Bavarian primary schools ( n = 724 children , 8.4 ± 0.7 years ) r and omized one to one to either an intervention school ( IS , n = 427 ) or a control school ( CS , n = 297 ) . Children in IS attended 10 health-related lessons at school over a period of 1 year . Parents and teachers attended two and three educational health-related lessons , respectively , and also received 10 newsletters on health issues . Daily physical activity ( ≥ 60 min/day ) , physical fitness ( six-item test battery ) , and anthropometric data were obtained at baseline and after 1 year . Physical activity and physical fitness increased in IS , but it failed to reach significant intervention effects . Nevertheless , a reduction in waist circumference was observed for all children [ mean change 1.7 cm ; 95 % confidence interval ( CI ) 1.2 - 2.3 ; P < 0.001 ) . This effect was more pronounced in overweight children ( > 90th percentile , n = 99 , mean change 3.2 cm ; 95 % CI 1.5 - 4.8 ; P < 0.001 ) . This easily administered preventative program involving children , parents , and teachers revealed that a generalized approach increasing physical activity will even be favorable in a subgroup of obese children BACKGROUND The objective of this study , focused on parents and children to reduce sedentary behavior , consumption of soft drinks and high-fat and salt containing snacks , and increase the consumption of fruits and vegetables , was to assess the effect of a six month intervention and an 18 month follow-up intervention on the body mass index , food consumption and physical activity of 2nd and 3rd grade elementary school children . METHODS This was a r and omized cluster controlled trial . School children were selected from 2nd and 3rd ( n = 532 ) grade . MEASUREMENTS BMI z
Output:
| No consistent pattern was found between either type of environment targeted , number of type of environment targeted , or the child 's targeted socio-cognitive determinants and intervention effectiveness .
DISCUSSION School-based interventions with direct parental involvement have the potential to improve children 's weight status , physical activity and sedentary behavior . |
MS213262 | ***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 We evaluated the efficiency of various amounts of local anesthesia and various numbers of injection sites to determine the most effective pain control with the least number of injections and the amount of injected medium in patients who underwent transrectal ultrasound guided prostate biopsy . MATERIAL S AND METHODS Transrectal ultrasound guided 8 core biopsy of the prostate was performed in 175 consecutive men . Patients were r and omized into 7 groups with 25 per group . Group 1 received 5 cc saline and groups 2 to 7 received 2.5 , 5 or 10 cc 1 % lidocaine injected as local anesthesia at basal or basal plus apical locations . The patients were then evaluated for pain and other complications to determine whether there was a difference regarding groups . RESULTS Mean pain scores were significantly lower than in saline group for all anesthesia injected groups except group 2 with a 2.5 cc bilateral basal injection . The most effective pain control was achieved by 10 cc anesthetic injections . Basal plus apical injections were not superior than only basal injections for pain control . There was no significant difference in the hematuria , hematospermia , rectal bleeding or infection rate among the groups . Increasing the number of injections and amount of lidocaine had no effect on complication rates . CONCLUSION Our placebo controlled , prospect i ve , r and omized study indicated that 10 cc local anesthetic injections supply significantly better pain control than lower doses for periprostatic nerve blockade during prostate biopsy . Although bilateral basal plus apical 10 cc lidocaine injections result ed in the lowest mean pain score , there was no statistically significant difference from 10 cc bilateral basal injections Introduction : To test the hypothesis that periprostatic block could completely relief prostatic biopsy-associated pain . Material s and Methods : Patients scheduled for transrectal ultrasound guided prostate biopsy were r and omized ( 1:1:1 ratio ) to no analgesia ( group A ) , endorectal enema of 1 % lidocaine gel ( group B ) or transrectal periprostatic block ( group C ) . All patients underwent 10 core TRUS-guided biopsy . After the procedure , a ten visual analogue pain score ( VAS ) from 0 = no discomfort to 10 = severe pain was administered to the biopsied patients and a global estimation of pain associated with the procedure was obtained . The study design included interim analysis of pain score after the first 60 patients were enrolled . Kruskal-Wallis test for unpaired data was used for statistical analysis . Data are presented as mean , median ( range ) . Results : Sixty patients were enrolled between May 2003 and December 2003 and all patients were evaluable . Mean and median age was 68.5 and 69 ( range 53–82 ) years , respectively . Mean and median PSA was 86.8 and 9 ng/ml ( range 0.58–4.111 ) , respectively . No major side effects were observed . Patients in group A scored at VAS a median 4 , mean 5.5 ± 2.3 ( range 3–10 ) . Patients in group B scored a median 4 , mean 5.5 ± 2.7 ( range 3–10 ) ( p = 0.237 ) . Patients receiving periprostatic injections of carbocaine ( group C ) scored a median 0 , mean 0.5 ± 0.8 ( range 0–2 ) . The level of pain reported by this group of patients was significantly different from those reported by patients who performed prostatic biopsy without anesthesia or with intrarectal anesthetic jelly ( p = 0.00001 ) . In the periprostatic block group 65 % of patients referred no pain after the procedure ( VAS = 0 ) while all patients in the other groups experience some degree of pain . Conclusion : The use of bilateral periprostatic block is a very effective and useful technique , well tolerated by the patient , which almost completely abolishes the pain and discomfort associated with the prostatic biopsy procedure Background : We aim to compare the degree of pain control and complications in three types of anesthesia using periprostatic nerve block ( PPNB ) plus intrarectal local anesthesia ( IRLA ) , low-dose spinal anesthesia , and intravenous ( IV ) sedation in patients undergoing transrectal ultrasound (TRUS)-guided prostate biopsy . Material s and Methods : In this clinical trial study , 106 patients were participated from December 2015 to December 2016 at Alzahra Hospital , Isfahan , Iran . Patients were r and omly allocated into three groups to receive PPNB plus IRLA ( n = 36 ) , low-dose spinal anesthesia ( n = 35 ) and IV sedation ( n = 35 ) before TRUS-guided prostate biopsy . Pain scores were recorded using a 10 point visual analog scale right after the biopsy was done . Early and late complications were assessed using a question naire after the procedure and in follow-up of patients . Results : Overall , the pain score in the low-dose spinal anesthesia group was significantly lower than PPNB plus IRLA and IV sedation groups ( P < 0.001 ) . The differences in pain scores between PPNB plus IRLA group and IV sedation group were not significant ( P = 0.30 ) . Urinary retraction and fever were significantly more frequent in low-dose spinal anesthesia and IV sedation , retrospectively ( P = 0.04 , P = 0.03 ) . No significant difference in late complications was found among the groups . Conclusion : This study demonstrates that low-dose spinal anesthesia is superior to PPNB plus IRLA and IV sedation in terms of pain controlling and was associated with higher tolerance of the examination and patient comfort PURPOSE Transrectal ultrasonography guided prostate biopsy is the principle procedure in the histological diagnosis of prostate cancer . Recently a trend toward increasing the number of cores has been popularized . This practice further increases the need for a proper anesthetic application . However , there is no consensus on a st and ard local anesthetic strategy , while groups at most institutions currently prefer periprostatic anesthesia . We prospect ively evaluated the contribution of intraprostatic anesthesia for transrectal prostate biopsies even when the sampling number was doubled to 12 cores . MATERIAL S AND METHODS A total of 200 patients who underwent prostate biopsy with transrectal ultrasound guidance were included . The 2 groups received the usual periprostatic anesthesia . Consequently patients were prospect ively r and omized into 2 groups . Group 1 received additional intraprostatic lidocaine injection , while group 2 received the same amount of injection of 0.9 % NaCl . The efficiency of applied local anesthesia was assessed by a visual analog pain scale . RESULTS The study groups were comparable regarding patient age , prostate size and cancer rate . Pain scores revealed that the combination of intraprostatic and periprostatic local anesthesia provided significantly better pain control than periprostatic infiltration alone . No difference was observed regarding the morbidity rate in the 2 groups . CONCLUSIONS The current study suggested that adding intraprostatic local anesthesia provides a significantly efficient strategy during transrectal ultrasound prostate biopsy , even in cases of 12-core sampling . Subsequent trials are needed to establish a st and ard analgesia policy for prostate biopsy We assessed the analgesic efficacy of levobupivacaine when administered as an adjuvant to diclofenac sodium in prostate biopsy pain management and effects of prostate biopsy on sexual function . Ninety patients underwent transrectal ultrasound (TRUS)‐guided biopsy of the prostate and were r and omly assigned to three groups : group D received diclofenac sodium suppository ; Group L received periprostatic injection of levobupivacaine ; group DL received diclofenac suppository and levobupivacaine in addition . Patients were asked to use a visual analogue scale score ( VAS ) question naire about pain after 10 core prostate biopsy . Sixty‐two patients reported to be prostate cancer‐free underwent further evaluation with the International Index of Erectile Function‐5 ( IIEF‐5 ) question naire at 1 and 3 months after biopsy . Mean pain scores during prostate biopsy were significantly lower in group DL and were superior to the group L and group D ( P < 0.001 ) . Mean IIEF‐5 score prior to biopsies was significantly higher when compared with the mean IIEF‐5 score 1 month after biopsy ( P < 0.0001 ) . Mean IIEF‐5 scores 1 month after biopsy were significantly lower when compared with the mean IIEF‐5 scores 3 months after biopsy ( P = 0.002 ) . TRUS‐guided prostate biopsies have a statistically significant impact on short‐term erectile function , but this difference is not clinical ly significant ; however , medium‐term erectile function is not affected both statistically and clinical ly OBJECTIVES To introduce two forms of anesthesia and compare them with st and ard local anesthesia techniques . METHODS A total of 114 consecutive patients underwent prostate needle biopsy . The patients were sequentially r and omized to receive different kinds of anesthesia : 2 % rectal lidocaine gel , 40 % dimethyl sulfoxide ( DMSO ) with lidocaine , perianal injection of 1 % lidocaine , or periprostatic nerve block . Pain perception was separately assessed for probe insertion and biopsies using a visual pain analog score . One-way analysis of variance was used to compare the data scale among the four groups . A linear regression model was used to define the independent variables that predicted the level of pain . RESULTS The groups were similar in terms of age , prostate-specific antigen levels , digital rectal examination findings , prostate volume , pain tolerance , biopsy time , and number of cores taken . The lowest pain scores for probe insertion were for the perianal injection and DMSO/lidocaine groups ( 0.89 and 1.38 , respectively ) . The difference between these scores and those for the other two groups was statistically significant ( P < 0.001 ) . Pain perception during biopsy did not differ significantly among the DMSO/lidocaine , perianal , or periprostatic groups and was greatest in the lidocaine gel group ( 4.147 ; P < 0.001 ) . We did not observe any statistically significant correlation between the pain level during probe insertion and biopsy and pain tolerance ( P = 0.514 and P = 0.788 , respectively ) . The anesthesia type was the strongest single predictor of the pain level during biopsy ( P < 0.001 ) . CONCLUSIONS The use of 40 % DMSO with lidocaine instilled into the rectal vault for 10 minutes avoids any need for injection and is capable of decreasing the discomfort or pain experienced during probe insertion and prostate biopsy comparable to the perianal and periprostatic protocol AIM This study was design ed to compare the effectiveness of intrarectal lidocaine gel versus periprostatic lidocaine injection during transrectal ultrasound (TRUS)-guided prostate biopsy . METHODS Ninety men undergoing transrectal prostate biopsy from July through December 2004 were r and omized into three groups of 30 patients each . Before the biopsy , patients in Group 1 received 20 mL of 2 % lidocaine gel intrarectally ; patients in Group 2 received 5 mL ( 2.5 mL per side ) of 2 % lidocaine solution injected near the junction of the seminal vesicle with the base of the prostate ( along the neurovascular bundles ) , and patients in Group 3 ( control group ) received 5 mL ( 2.5 mL per side ) of normal saline injected along the neurovascular bundles . Pain level after the biopsy was assessed using a 10-point linear visual analog scale ( VAS ) . Results were statistically compared by the Wilcoxon Rank Sum test . RESULTS Patients in Group 2 had significantly lower VAS scores than those in Group 3 ( 3.6 + /- 2.1 vs 5.8 + /- 1.9 , P < 0.0001 ) , but those in Group 1 did not ( 5.5 + /- 2.7 vs 5.8 + /- 1.9 , P = 0.67 ) . Gross hematuria , rectal bleeding , and hemospermia occurred in 36 ( 40.0 % ) , 6 ( 7 % ) and 5 ( 6 % ) patients . One patient had temporary vasovagal syncope . No patient reported febrile urinary tract infection or urinary retention . CONCLUSIONS Periprostatic injection of local anaesthetic is a safe technique that significantly reduces pain during prostate biopsy , whereas intrarectal lidocaine injection did not reduce pain . This safe , simple technique should be applied in men undergoing TRUS-guided prostate biopsy to limit patient discomfort OBJECTIVE To compare the level of pain experienced by patients during transrectal ultrasound-guided prostatic biopsy using intrarectal 2 % lidocaine gel versus plain lubricant gel . DESIGN Prospect i ve double-blind r and omised controlled trial . SETTING Regional hospital , Hong Kong . PATIENTS From March 2002 to December 2003 , patients who underwent ultrasound-guided prostate biopsy at a Geriatric Urology Centre . MAIN OUTCOME MEASURES Pain and discomfort scores measured by horizontal visual analogue scales . RESULTS A total of 338 consecutive patients were r and omised to lidocaine gel or plain lubricant gel groups . The two groups were statistically similar in demographic and disease characteristics . There were no significant statistical differences in pain or discomfort
Output:
| Our results demonstrate that PNB + IVS ( rank 1 ) and SPA ( rank 2 ) were the most effective methods for pain control .
In conclusion , the most effective way to alleviate PBx-related pain appears to be PNB + IVS and SPA . |
MS213263 | ***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: RATIONALE Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis . OBJECTIVES To test whether vitamin D supplementation of patients with tuberculosis ( TB ) improved clinical outcome and reduced mortality . METHODS We conducted a r and omized , double-blind , placebo-controlled trial in TB clinics at a demographic surveillance site in Guinea-Bissau . We included 365 adult patients with TB starting antituberculosis treatment ; 281 completed the 12-month follow-up . The intervention was 100,000 IU of cholecalciferol or placebo at inclusion and again 5 and 8 months after the start of treatment . MEASUREMENTS AND MAIN RESULTS The primary outcome was reduction in a clinical severity score ( TBscore ) for all patients with pulmonary TB . The secondary outcome was 12-month mortality . No serious adverse effects were reported ; mild hypercalcemia was rare and present in both arms . Reduction in TBscore and sputum smear conversion rates did not differ among patients treated with vitamin D or placebo . Overall mortality was 15 % ( 54 of 365 ) at 1 year of follow-up and similar in both arms ( 30 of 187 for vitamin D treated and 24 of 178 for placebo ; relative risk , 1.19 [ 0.58 - 1.95 ] ) . HIV infection was seen in 36 % ( 131 of 359 ) : 21 % ( 76 of 359 ) HIV-1 , 10 % ( 36 of 359 ) HIV-2 , and 5 % ( 19 of 357 ) HIV-1 + 2 . CONCLUSIONS Vitamin D does not improve clinical outcome among patients with TB and the trial showed no overall effect on mortality in patients with TB ; it is possible that the dose used was insufficient . Clinical trial registered with www.controlled-trials.com/is rct n ( IS RCT N35212132 ) BACKGROUND Results from observational studies suggest that micronutrient status is a determinant of the progression of human immunodeficiency virus ( HIV ) disease . METHODS We enrolled 1078 pregnant women infected with HIV in a double-blind , placebo-controlled trial in Dar es Salaam , Tanzania , to examine the effects of daily supplements of vitamin A ( preformed vitamin A and beta carotene ) , multivitamins ( vitamins B , C , and E ) , or both on progression of HIV disease , using survival models . The median follow-up with respect to survival was 71 months ( interquartile range , 46 to 80 ) . RESULTS Of 271 women who received multivitamins , 67 had progression to World Health Organization ( WHO ) stage 4 disease or died -- the primary outcome --as compared with 83 of 267 women who received placebo ( 24.7 percent vs. 31.1 percent ; relative risk , 0.71 ; 95 percent confidence interval , 0.51 to 0.98 ; P=0.04 ) . This regimen was also associated with reductions in the relative risk of death related to the acquired immunodeficiency syndrome ( 0.73 ; 95 percent confidence interval , 0.51 to 1.04 ; P=0.09 ) , progression to WHO stage 4 ( 0.50 ; 95 percent confidence interval , 0.28 to 0.90 ; P=0.02 ) , or progression to stage 3 or higher ( 0.72 ; 95 percent confidence interval , 0.58 to 0.90 ; P=0.003 ) . Multivitamins also result ed in significantly higher CD4 + and CD8 + cell counts and significantly lower viral loads . The effects of receiving vitamin A alone were smaller and for the most part not significantly different from those produced by placebo . Adding vitamin A to the multivitamin regimen reduced the benefit with regard to some of the end points examined . CONCLUSIONS Multivitamin supplements delay the progression of HIV disease and provide an effective , low-cost means of delaying the initiation of antiretroviral therapy in HIV-infected women OBJECTIVES We have previously investigated the role of either : aspirin and micronutrients or aspirin , micronutrients and chloroquine ( CQ ) in the management of asymptomatic HIV infected individuals . In this paper , we report the use of these combinations in the management of patients with AIDS , defined as CD4 count < 200 cells Background : Iron deficiency is common among female injection drug users , but it is unclear whether iron supplementation can reduce anemia and improve iron status without increasing plasma hepatitis C virus ( HCV ) or HIV RNA levels . Methods : We conducted a phase 3 , double-blind , r and omized , controlled clinical trial of daily micronutrients with 18 mg of iron ( iron group ) versus micronutrients without iron ( control group ) for 12 months among hepatitis C-positive female injection drug users in Baltimore , Maryl and . The main outcome measures were hemoglobin , markers of iron status , plasma HCV RNA , plasma HIV RNA , and liver enzymes at 6 and 12 months of follow-up . Results : Four hundred fifty-eight women ( 320 HIV-negative and 138 HIV-positive ) enrolled in the trial . There were no significant differences in the proportion of women with anemia , ferritin < 30 ng/mL , log10 plasma HCV RNA , or log10 plasma HIV RNA between treatment groups at enrollment . The proportion with anemia in the iron and control groups , respectively , was 20.7 % versus 31.3 % ( P = 0.026 ) at 6 months and 26.2 % versus 30.4 % ( P = 0.5 ) at 12 months ; with ferritin < 30 ng/mL , the proportion was 29.2 % versus 55.5 % ( P < 0.0001 ) at 6 months and 26.2 % versus 46.9 % ( P = 0.0018 ) at 12 months . In the iron and control groups , respectively , mean log10 plasma HCV RNA ( IU/mL ) was 5.2 versus 5.2 ( P = 0.86 ) at 6 months and 5.4 versus 5.3 ( P = 0.6 ) at 12 months . Among HIV-positive subjects , mean log10 plasma RNA ( copies/mL ) in the iron and placebo groups , respectively , was 3.8 versus 3.7 ( P = 0.75 ) at 6 months and 3.7 versus 4.1 ( P = 0.19 ) at 12 months . There were no significant differences in liver enzyme levels between the treatment groups at enrollment , 6 months , and 12 months . Conclusions : A daily micronutrient supplement with iron can reduce anemia and improve iron status in female injection drug users without increasing plasma HCV or HIV RNA levels or altering liver enzymes BACKGROUND Evidence has accumulated from observational studies that people eating more fruits and vegetables , which are rich in beta-carotene ( a violet to yellow plant pigment that acts as an antioxidant and can be converted to vitamin A by enzymes in the intestinal wall and liver ) and retinol ( an alcohol chemical form of vitamin A ) , and people having higher serum beta-carotene concentrations had lower rates of lung cancer . The Beta-Carotene and Retinol Efficacy Trial ( CARET ) tested the combination of 30 mg beta-carotene and 25,000 IU retinyl palmitate ( vitamin A ) taken daily against placebo in 18314 men and women at high risk of developing lung cancer . The CARET intervention was stopped 21 months early because of clear evidence of no benefit and substantial evidence of possible harm ; there were 28 % more lung cancers and 17 % more deaths in the active intervention group ( active = the daily combination of 30 mg beta-carotene and 25,000 IU retinyl palmitate ) . Promptly after the January 18 , 1996 , announcement that the CARET active intervention had been stopped , we published preliminary findings from CARET regarding cancer , heart disease , and total mortality . PURPOSE We present for the first time results based on the pre-specified analytic method , details about risk factors for lung cancer , and analyses of subgroups and of factors that possibly influence response to the intervention . METHODS CARET was a r and omized , double-blinded , placebo-controlled chemoprevention trial , initiated with a pilot phase and then exp and ed 10-fold at six study centers . Cigarette smoking history and status and alcohol intake were assessed through participant self-report . Serum was collected from the participants at base line and periodically after r and omization and was analyzed for beta-carotene concentration . An Endpoints Review Committee evaluated endpoint reports , including pathologic review of tissue specimens . The primary analysis is a stratified logrank test for intervention arm differences in lung cancer incidence , with weighting linearly to hypothesized full effect at 24 months after r and omization . Relative risks ( RRs ) were estimated by use of Cox regression models ; tests were performed for quantitative and qualitative interactions between the intervention and smoking status or alcohol intake . O'Brien-Fleming boundaries were used for stopping criteria at interim analyses . Statistical significance was set at the .05 alpha value , and all P values were derived from two-sided statistical tests . RESULTS According to CARET 's pre-specified analysis , there was an RR of 1.36 ( 95 % confidence interval [ CI ] = 1.07 - 1.73 ; P = .01 ) for weighted lung cancer incidence for the active intervention group compared with the placebo group , and RR = 1.59 ( 95 % CI = 1.13 - 2.23 ; P = .01 ) for weighted lung cancer mortality . All subgroups , except former smokers , had a point estimate of RR of 1.10 or greater for lung cancer . There are suggestions of associations of the excess lung cancer incidence with the highest quartile of alcohol intake ( RR = 1.99 ; 95 % CI = 1.28 - 3.09 ; test for heterogeneity of RR among quartiles of alcohol intake has P = .01 , unadjusted for multiple comparisons ) and with large-cell histology ( RR = 1.89 ; 95 % CI = 1.09 - 3.26 ; test for heterogeneity among histologic categories has P = .35 ) , but not with base-line serum beta-carotene concentrations . CONCLUSIONS CARET participants receiving the combination of beta-carotene and vitamin A had no chemopreventive benefit and had excess lung cancer incidence and mortality . The results are highly consistent with those found for beta-carotene in the Alpha-Tocopherol Beta-Carotene Cancer Prevention Study in 29133 male smokers in Finl and BACKGROUND In observational studies , the zinc status of HIV-infected persons has been associated with both positive and adverse clinical outcomes . Such endpoints may affect the risk of adverse birth outcomes among HIV-infected women . OBJECTIVE We examined the effects of zinc supplements on birth outcomes , hematologic indicators , and counts of T lymphocyte subsets among 400 HIV-infected pregnant women . DESIGN Eligible women between 12 and 27 wk of gestation were r and omly assigned to daily oral supplementation with either 25 mg Zn or placebo between recruitment and 6 wk after delivery . All women received iron , folic acid , and multivitamin supplements irrespective of the experimental assignment . RESULTS We observed no significant differences in birth weight , duration of gestation , or fetal and neonatal mortality between women in the zinc and placebo groups . Hemoglobin concentrations increased between baseline and 6 wk postpartum in both groups . However , the rise in hemoglobin over this period was significantly lower ( P = 0.03 ) in the zinc group ( x + /- SD : 11.5 + /- 17.9 g/L ) than in the placebo group ( 15.2 + /- 18.6 g/L ) . Similarly , the changes in red blood cell count and in packed cell volume over the same period were significantly lower in the zinc group ( P < 0.01 and P = 0.01 , respectively ) . Zinc had no effect on CD4(+ ) , CD8(+ ) , or CD3(+ ) cell counts during the follow-up period . CONCLUSION Because of the lack of beneficial effects of zinc on adverse pregnancy outcomes and the likelihood of negative effects on hemoglobin concentrations , no compelling evidence exists to support the addition of zinc to prenatal supplements intended for pregnant HIV-infected women Iron deficiency is one of the main causes of anemia during pregnancy , although other micronutrient deficiencies may play a role . We examined the effects of daily antenatal and postnatal supplementation with four combinations of micronutrients on maternal hematologic indicators in a double-masked r and omized controlled community trial . Communities , called sectors , were r and omly assigned to supplementation with folic acid ( 400 microg ) , folic acid plus iron ( 60 mg ) , folic acid plus iron and zinc ( 30 mg ) and folic acid plus iron , zinc and 11 other micronutrients , each at the approximate recommended daily allowance for pre
Output:
| None of the six trials of vitamin A or beta-carotene supplementation in adults demonstrated any significant reduction in HIV disease progression .
No significant adverse effects of vitamin A in adults or children have been reported .
Zinc supplements reduced diarrhoeal morbidity and had no adverse effects on disease progression in a single safety trial in South African children .
No significant clinical benefits were found from zinc supplementation of pregnant Tanzanian women or Peruvian adults with persistent diarrhoea .
Vitamin A supplementation is beneficial and safe in HIV-infected children , but further evidence is needed to establish if supplementation confers similar benefits in HIV-infected adults .
Zinc is safe in HIV-infected adults and children .
It may have similar benefits in HIV-infected children and adults , and uninfected children with diarrhoea , as it does in HIV-uninfected children . |
MS213264 | ***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: Eighty-five diabetic patients who were proficient in English were studied to assess the impact of educational material of varying literacy levels on patient comprehension . Two sample s of available diabetes foot care material of Grade 11 and 9 readability ( measured by SMOG formula ) and purpose ly written in-house material of Grade 6 readability were used . Patients were r and omized to read information of either Grade 6 and Grade 11 or Grade 6 and Grade 9 readability . Socio-demographic data and reading habits were collected to allow for identification of literacy markers . The mean CLOZE score ( a measure of comprehension ) was better in patients who read the Grade 6 information than for both the Grade 11 and Grade 9 information ( 59.5 + /- 11.8 , 46.8 + /- 22.0 , 45.8 + /- 22.2 respectively , p < 0.001 ) . When evaluated in terms of percent of patients that could independently underst and the material , Grade 6 information outperformed the Grade 11 and Grade 9 information ( 60 % , 19 % , 21 % , respectively , p < 0.001 ) . For the Grade 11 and Grade 9 information , poorer comprehension was associated with a non-English speaking background , early school leaving age , infrequent reading habits , and preference for tabloids ( p < 0.02 ) . Comprehension when patients read the Grade 6 information was no longer dependent on two of the four identified literacy markers . We conclude that reducing literacy dem and s of health literature improves patients ' comprehension . Attention to socio-demographic data and reading habits can assist educators in assessing patients ' literacy status and ensuring patients are given literature of compatible readability OBJECTIVE To test whether a theory-based , literacy , and culturally tailored self-management intervention , Latinos en Control , improves glycemic control among low-income Latinos with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 252 patients recruited from community health centers were r and omized to the Latinos en Control intervention or to usual care . The primarily group-based intervention consisted of 12 weekly and 8 monthly sessions and targeted knowledge , attitudes , and self-management behaviors . The primary outcome was HbA1c . Secondary outcomes included diet , physical activity , blood glucose self-monitoring , diabetes knowledge and self-efficacy , and other physiological factors ( e.g. , lipids , blood pressure , and weight ) . Measures were collected at baseline and at 4- and 12-month follow-up . Change in outcomes over time between the groups and the association between HbA1c and possible mediators were estimated using mixed-effects models and an intention-to-treat approach . RESULTS A significant difference in HbA1c change between the groups was observed at 4 months ( intervention −0.88 [ −1.15 to −0.60 ] versus control −0.35 [ −0.62 to 0.07 ] , P < 0.01 ) , although this difference decreased and lost statistical significance at 12 months ( intervention −0.46 [ −0.77 to −0.13 ] versus control −0.20 [ −0.53 to 0.13 ] , P = 0.293 ) . The intervention result ed in significant change differences in diabetes knowledge at 12 months ( P = 0.001 ) , self-efficacy ( P = 0.001 ) , blood glucose self-monitoring ( P = 0.02 ) , and diet , including dietary quality ( P = 0.01 ) , kilocalories consumed ( P < 0.001 ) , percentage of fat ( P = 0.003 ) , and percentage of saturated fat ( P = 0.04 ) . These changes were in turn significantly associated with HbA1c change at 12 months . CONCLUSIONS Literacy-sensitive , culturally tailored interventions can improve diabetes control among low-income Latinos ; however , strategies to sustain improvements are needed BACKGROUND Type 2 diabetes is up to four times more common in British Asians , but they know little about its management and complications . AIM To design and evaluate a structured pictorial teaching programme for Pakistani Moslem patients in Manchester with type 2 diabetes . METHOD A r and omized controlled trial of pictorial flashcard one-to-one education in 201 patients attending a hospital outpatient clinic or diabetic clinics in ten general practice s in Manchester . Patients ' knowledge , self-caring skills and attitudes to diabetes were measured on four topics before the structured teaching , and compared with results six months later . RESULTS All parameters of knowledge were increased in the study group ; for example , percentage scores for correctly identifying different food values increased from 57 % to 71 % ( Analysis of Variance ( ANOVA ) adjusted difference + 11.8 % ) and knowledge of one diabetic complication from 18 % to 78 % . Self-caring behaviour improved , with 92 % of patients doing regular glucose tests at six months compared with 63 % at the start . Attitudinal views were more resistant to change , with patients still finding it hard to choose suitable foods at social occasions . Haemoglobin A1c control improved by 0.34 % over six months ( ANOVA adjusted difference , 95 % CI -0.8 % to + 0.1 % ) . CONCLUSION It is concluded that this health education programme can empower Asian diabetics to take control of their diets , learn to monitor and interpret glucose results , and underst and the implication s of poor glycaemic control for diabetic complications BACKGROUND Cardiovascular disease ( CVD ) and diabetes account for one-third of the mortality difference between African American and white patients . We evaluated the effect of a CVD risk reduction intervention in African Americans with diabetes . METHODS We r and omized 359 African Americans with type 2 diabetes to receive usual care or a nurse telephone intervention . The 12-month intervention provided monthly self-management support and quarterly medication management facilitation . Co primary outcomes were changes in systolic blood pressure ( SBP ) , hemoglobin A1c ( HbA1c ) , and low-density lipoprotein cholesterol ( LDL-C ) over 12 months . We estimated between-intervention group differences over time using linear mixed-effects models . The secondary outcome was self-reported medication adherence . RESULTS The sample was 72 % female ; 49 % had low health literacy , and 37 % had annual income < $ 10,000 . Model-based estimates for mean baseline SBP , HbA1c , and LDL-C were 136.8 mm Hg ( 95 % CI 135.0 - 138.6 ) , 8.0 % ( 95 % CI 7.8 - 8.2 ) , and 99.1 mg/dL ( 95 % CI 94.7 - 103.5 ) , respectively . Intervention patients received 9.9 ( SD 3.0 ) intervention calls on average . Primary providers replied to 76 % of nurse medication management facilitation contacts , 18 % of these result ed in medication changes . There were no between-group differences over time for SBP ( P = .11 ) , HbA1c ( P = .66 ) , or LDL-C ( P = .79 ) . Intervention patients were more likely than those receiving usual care to report improved medication adherence ( odds ratio 4.4 , 95 % CI 1.8 - 10.6 , P = .0008 ) , but adherent patients did not exhibit relative improvement in primary outcomes . CONCLUSIONS This intervention improved self-reported medication adherence but not CVD risk factor control among African Americans with diabetes . Further research is needed to determine how to maximally impact CVD risk factors in African American patients Objective To examine the prevalence of outcome reporting bias — the selection for publication of a subset of the original recorded outcome variables on the basis of the results — and its impact on Cochrane review s. Design A nine point classification system for missing outcome data in r and omised trials was developed and applied to the trials assessed in a large , unselected cohort of Cochrane systematic review s. Research ers who conducted the trials were contacted and the reason sought for the non-reporting of data . A sensitivity analysis was undertaken to assess the impact of outcome reporting bias on review s that included a single meta- analysis of the review primary outcome . Results More than half ( 157/283 ( 55 % ) ) the review s did not include full data for the review primary outcome of interest from all eligible trials . The median amount of review outcome data missing for any reason was 10 % , whereas 50 % or more of the potential data were missing in 70 ( 25 % ) review s. It was clear from the publications for 155 ( 6 % ) of the 2486 assessable trials that the research ers had measured and analysed the review primary outcome but did not report or only partially reported the results . For reports that did not mention the review primary outcome , our classification regarding the presence of outcome reporting bias was shown to have a sensitivity of 88 % ( 95 % CI 65 % to 100 % ) and specificity of 80 % ( 95 % CI 69 % to 90 % ) on the basis of responses from 62 trialists . A third of Cochrane review s ( 96/283 ( 34 % ) ) contained at least one trial with high suspicion of outcome reporting bias for the review primary outcome . In a sensitivity analysis undertaken for 81 review s with a single meta- analysis of the primary outcome of interest , the treatment effect estimate was reduced by 20 % or more in 19 ( 23 % ) . Of the 42 meta-analyses with a statistically significant result only , eight ( 19 % ) became non-significant after adjustment for outcome reporting bias and 11 ( 26 % ) would have overestimated the treatment effect by 20 % or more . Conclusions Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane review s. Individuals conducting systematic review s need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence . Extra care is required during data extraction , review ers should identify when a trial reports that an outcome was measured but no results were reported or events observed , and contact with trialists should be encouraged BACKGROUND AND AIM The risk of death from coronary heart disease ( CHD ) in women with diabetes is more than three times that of non-diabetic women . We assessed the difference in CHD risk levels of Afro-Caribbean diabetic women provided with facilities for self-monitoring of blood glucose and their counterparts without such facilities MATERIAL S AND METHODS Forty-nine patients who never used gluco-meters were studied as intervention ( 23 ) and control ( 26 ) groups . The intervention group was trained on self-monitoring of blood glucose . At baseline , BP , anthropometric indices , and fasting blood glucose of all patients were measured . Subsequently , the intervention patients were provided with gluco-meters , testing strips , and advised to self-monitor fasting and postpr and ial blood glucose every other day for 6 months . CHD risk was determined with the United Kingdom Prospect i ve Diabetes Study risk engine calculator . RESULTS The age , duration of diagnosis of diabetes , BP , and anthropometric indices were similar in the two groups ( all , P > 0.05 ) . The majority of the patients were unemployed or retired with only primary education . After 3 months , the HbA 1c levels of the control patients did not change ( 8.3 ± 0.4 % vs. 7.8 ± 0.4 % , P > 0.05 ) whereas the HbA 1c levels of the intervention patients reduced significantly from the baseline at 3 ( 9.2 ± 0.4 % vs. 7.4 ± 0.3 % , P < 0.001 ) and 6 ( 9.2 ± 0.4 % vs. 7.3 ± 0.3 % , P < 0.001 ) months . The 10-year CHD risk level of the intervention group was remarkably reduced from the baseline level after 6 months ( 7.4 ± 1.3 % vs. 4.5 ± 0.9 % ) of the study . CONCLUSION Provision of facilities for self-monitoring of blood glucose in Afro-Caribbean women with type 2 diabetes improves both their glycemic control and CHD risk profile The promotion of regular physical activity for people with type 2 diabetes poses a challenge for public health authorities . The purpose of this study was to evaluate the efficiency of a computer-tailoring print-based intervention to promote the adoption of regular physical activity among people with type 2 diabetes . An experimental design was used ; 325 participants between the age of 35 and 55 years old were r and omized in one of two experimental conditions : the computer-tailoring intervention and the generic intervention . The two dependant variables were the frequency of participation and the intention to participate in leisure-time physical activities . Among the research hypotheses , only one was confirmed : the first computer-tailoring print on the practice of physical activity was more efficient than the first generic intervention at 1-month follow-up . Other similar studies will be necessary to determine the real potential of this type of approach for people with type 2 diabetes in a real-life setting Purpose The purpose of the study was to test the feasibility and efficacy of a diabetes self-management and education program for Chinese Americans in a support group format . The rationale for the study was to create culturally appropriate diabetes education and management programs in response to the growing diabetes prevalence among Chinese Americans . The investigators hypothesized that participants will have improved diabetes knowledge and practice s , hemoglobin A1C
Output:
| Other outcome measures ( blood pressure , body mass index , self-efficacy and empowerment ) also showed neutral effects compared with control groups .
Culturally appropriate health education has short- to medium-term effects on glycaemic control and on knowledge of diabetes and healthy lifestyles . |
MS213265 | ***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 consisted of secondary analyses of data from 2 r and omized clinical trials to test whether pretherapy cognitions predict CBT outcomes . The sample consisted of 155 primary insomnia patients with sleep maintenance complaints . Of these , 98 were r and omized to CBT , 23 were assigned to progressive muscle relaxation training ( PMR ) , and 34 were assigned to a control ( sham therapy or wait-list ) condition ( CON ) . All patients completed the Dysfunctional Beliefs and Attitudes about Sleep Scale ( DBAS ) , a sleep-related Self-Efficacy Scale ( SES ) and nightly sleep diaries for 2 weeks prior to receiving their assigned treatment . They then completed sleep diaries throughout an 8-week acute treatment period and during a 2-week period at a posttherapy follow-up . A subset of the sample ( n=67 ) also completed polysomnography immediately before and after completing their assigned treatment . Preliminary regression analyses conducted with a small subset ( n=15 ) of the patients receiving CBT showed those with relatively high levels of unhelpful sleep-related beliefs ( Type 1 patients ) , as reflected by their pretherapy responses to the DBAS and SES question naires , showed markedly greater reductions in nocturnal wakefulness in response to CBT than did those ( Type 2 patients ) reporting less pronounced sleep-related beliefs . Given these findings , we used the regression equation derived from our initial analyses to dichotomize our entire sample into Type 1 ( n=82 ; 52.9 % ) and Type 2 ( n=73 ; 47.1 % ) subgroups . Subsequent comparisons showed CBT-treated Type 1 patients had significantly less wake time after sleep onset during most of the 8-week treatment phase than did the Type 1 and 2 individuals assigned to either PMR or CON . Relative to patients assigned to the PMR and CON conditions , CBT-treated Type 1 patients showed better performance across multiple subjective and objective benchmarks of clinical ly significant improvement , whereas the CBT-treated Type 2 patients did not . Results suggest that insomnia patients ' pretherapy cognitive dispositions predict CBT outcome , and those with a pronounced sense of sleep-related helplessness are best suited for this treatment which targets this cognitive stance In a prospect ive-longitudinal study of a representative birth cohort , we tested why stressful experiences lead to depression in some people but not in others . A functional polymorphism in the promoter region of the serotonin transporter ( 5-HT T ) gene was found to moderate the influence of stressful life events on depression . Individuals with one or two copies of the short allele of the 5-HT T promoter polymorphism exhibited more depressive symptoms , diagnosable depression , and suicidality in relation to stressful life events than individuals homozygous for the long allele . This epidemiological study thus provides evidence of a gene-by-environment interaction , in which an individual 's response to environmental insults is moderated by his or her genetic makeup OBJECTIVE The purpose of this study was to examine whether there is a bidirectional relationship between , on one h and , anxiety and depression and , on the other h and , insomnia over the course of a year . METHODS A r and omly selected sample of 3000 participants from the general population filled out a baseline survey ( N=1812 ) and a 1-year follow-up survey ( N=1498 ) on anxiety , depression , and insomnia . RESULTS On cross-sectional analyses , bivariate correlations showed that anxiety , depression , and insomnia were significantly intercorrelated ( varphi=.31-.54 ) . On prospect i ve analyses , logistic regression analyses demonstrated that anxiety at baseline [ odds ratio (OR)=4.27 ( 8 % of variance ) ] and depression at baseline [ OR=2.28 ( 2 % of variance ) ] were related to new cases of insomnia on follow-up . Furthermore , insomnia at baseline was related to new episodes of high anxiety and high depression on follow-up [ OR=2.30 ( 2 % of variance ) and OR=3.51 ( 4 % of variance ) , respectively ] . CONCLUSION Evidence suggests that there is a bidirectional relationship between , on one h and , anxiety and depression and , on the other h and , insomnia . This suggests that anxiety , depression , and insomnia are intertwined over time , implying implication s for theoretical conceptualizations and interventions The aims of this study were to measure the error in sleep estimation in normal controls and subjects with primary insomnia to establish the minimum amount of sleep needed for reliable subjective estimation and to depict the distribution of the error in sleep estimation in both groups . A two-step retrospective ( study 1 ) and prospect i ve ( study 2 ) validation study was carried out . Study 1 included 288 normal subjects [ 176 females and 112 males , mean age 58.5 years , st and ard deviation ( SD ) 7.23 ] . Study 2 included 159 patients ( 98 females and 61 males ; mean age 49.1 years , SD 12.71 ) with primary insomnia . Participants underwent a full-night polysomnographic study , followed by a morning assessment of subjective sleep parameters . A misperception index ( MI ) was computed using the following formula : MI = [ objective total sleep time (oTST)-subjective total sleep time (sTST)]/oTST . The statistical properties of this index were analysed in detail in both groups . In controls , the Bl and -Altman test demonstrated the reliability of this index for values of oTST > 120 min . Healthy subjects estimated their sleep time correctly , while insomniacs largely underestimated their sleep time . Statistical analysis of the distribution of MI in insomnia patients disclosed the presence of two subgroups , one with moderate sleep misperception ( 132 patients ) and the other with high sleep misperception ( 27 patients ) . The latter presented MI values > or=0.9 , exhibiting statistical properties different from those with MI < 0.9 and from normal subjects . The MI gives a reliable and immediate description of sleep misperception in healthy and insomnia subjects . Its application supports the existence of the high misperception of insomnia as a separate pathological entity STUDY OBJECTIVE To examine the association between depression and three subtypes of insomnia , namely , difficulty initiating sleep ( DIS ) , early morning awakening ( EMA ) , and difficulty maintaining sleep ( DMS ) . DESIGN Cross-sectional and longitudinal study . SETTING Community dwellers in Japan . PARTICIPANTS Nationally representative sample s of adults aged 65 and over ( total N=4,997 ) were selected by a multistage stratified r and om sampling method in 1999 and were interviewed face-to-face in 1999 , 2001 , 2003 , and 2006 . Those who responded to the 3rd survey conducted in 2003 and the 4th survey conducted in 2006 were used in this study . MEASUREMENT AND RESULTS Depression was evaluated according to the 11-item short form of the CES-D scale at 2 points in time . Insomnia subtypes were assessed by self-reported measures . A logistic regression was employed to examine the association between insomnia subtypes and the presence of depression , controlling for relevant factors . A cross-sectional analysis based on the 2003 data demonstrated statistically significant odds ratios ( ORs ) for DIS and EMA . In the longitudinal study , DIS at the time of the 3rd survey was found to be significantly related to the presence of depression at the time of the 4th survey , with an odds ratio ( 95%CI ) of 1.592 ( 1.012 to 2.504 ) . EMA ( OR 1.070 ; 95 % CI , 0.664 to 1.723 ) and DMS ( OR 1.215 ; 95 % CI , 0.860 to 1.716 ) , however , were not found to be significantly related to the presence of depression . CONCLUSION The longitudinal study revealed a statistically significant relationship , controlling for other relevant factors , between DIS and the presence of depression three years later , but not between EMA or DMS and depression . Based on our findings , we recommend that the association between insomnia subtypes and depression be studied longitudinally in clinical setting Background Psychiatric distress and insomnia symptoms exhibit similar patterning by gender and socioeconomic position . Prospect i ve evidence indicates a bi-directional relationship between psychiatric distress and insomnia symptoms so similarities in social patterning may not be coincidental . Treatment for insomnia can also improve distress outcomes . We investigate the extent to which the prospect i ve patterning of distress over 20 years is associated with insomnia symptoms over that period . Methods 999 respondents to the Twenty-07 Study had been followed for 20 years from approximately ages 36–57 ( 73.2 % of the living baseline sample ) . Psychiatric distress was measured using the GHQ-12 at baseline and at 20-year follow-up . Gender and social class were ascertained at baseline . Insomnia symptoms were self-reported approximately every five years . Latent class analysis was used to classify patterns of insomnia symptoms over the 20 years . Structural Equation Models were used to assess how much of the social patterning of distress was associated with insomnia symptoms . Missing data was addressed with a combination of multiple-imputation and weighting . Results Patterns of insomnia symptoms over 20 years were classified as either healthy , episodic , developing or chronic . Respondents from a manual social class were more likely to experience episodic , developing or chronic patterns than those from non-manual occupations but this was mostly explained by baseline psychiatric distress . People in manual occupations experiencing psychiatric distress however were particularly likely to experience chronic patterns of insomnia symptoms . Women were more likely to experience a developing pattern than men , independent of baseline distress . Psychiatric distress was more persistent over the 20 years for those in manual social classes and this effect disappeared when adjusting for insomnia symptoms . Irrespective of baseline symptoms , women , and especially those in a manual social class , were more likely than men to experience distress at age 57 . This overall association for gender , but not the interaction with social class , was explained after adjusting for insomnia symptoms . Sensitivity analyses supported these findings . Conclusions Gender and socioeconomic inequalities in psychiatric distress are strongly associated with inequalities in insomnia symptoms . Treatment of insomnia or measures to promote healthier sleeping may therefore help alleviate inequalities in psychiatric distress BACKGROUND AND PURPOSE To estimate the prevalence of insomnia symptoms and syndrome in the general population , describe the types of self-help treatments and consultations initiated for insomnia , and examine help-seeking determinants . PATIENTS AND METHODS A r and omly selected sample of 2001 French-speaking adults from the province of Quebec ( Canada ) responded to a telephone survey about sleep , insomnia , and its treatments . RESULTS Of the total sample , 25.3 % were dissatisfied with their sleep , 29.9 % reported insomnia symptoms , and 9.5 % met criteria for an insomnia syndrome . Thirteen percent of the respondents had consulted a healthcare provider specifically for insomnia in their lifetime , with general practitioners being the most frequently consulted . Daytime fatigue ( 48 % ) , psychological distress ( 40 % ) , and physical discomfort ( 22 % ) were the main determinants prompting individuals with insomnia to seek treatment . Of the total sample , 15 % had used at least once herbal/dietary products to facilitate sleep and 11 % had used prescribed sleep medications in the year preceding the survey . Other self-help strategies employed to facilitate sleep included reading , listening to music , and relaxation . CONCLUSIONS These findings confirm the high prevalence of insomnia in the general population . While few insomnia sufferers seek professional consultations , many individuals initiate self-help treatments , particularly when daytime impairments such as fatigue become more noticeable . Improved knowledge of the determinants of help-seeking behaviors could guide the development of effective public health prevention and intervention programs to promote healthy sleep STUDY OBJECTIVES To determine whether the frequency spectrum of the sleep EEG is a physiologic correlate of 1 ) the degree to which individuals with persistent primary insomnia ( PPI ) underestimate their sleep time compared with the traditionally scored polysomnogram ( PSG ) and 2 ) the sleep complaints in PPI subjects who have relatively long traditionally scored PSG sleep times and relatively greater underestimation of sleep time . DESIGN We compared EEG frequency spectra from REM and NREM sleep in PPI subjects subtyped as subjective insomnia sufferers ( those with relatively long total sleep time and relative underestimation of sleep time compared with PSG ) , and objective insomnia sufferers ( those with relatively short PSG total sleep time ) with EEG frequency spectra in normals . We also studied the correlation between these indices and the degree of underestimation of sleep . Further , we determined the degree to which sleep EEG indexes related to sleep complaints . SETTING Duke University Medical Center Sleep Laboratory . PARTICIPANTS Normal ( N=20 ) , subjective insomnia ( N=12 ) , and objective insomnia ( N=18 ) subjects . INTERVENTIONS N/A. MEASUREMENTS AND RESULTS Lower delta and greater alpha , sigma , and beta NREM EEG activity were found in the patients with subjective insomnia but not those with objective insomnia , compared with the normal subjects . These results were robust to changes in the subtyping criteria . No effects were found for REM spectral indexes . Less delta non- REM EEG activity predicted greater deviation between subjective and PSG estimates of sleep time across all subjects . For the subjective insomnia subjects , diminished low-frequency and elevated higher frequency non- REM EEG activity was associated with
Output:
| The review clearly indicates that characteristics of insomnia may not be limited to sleep .
Reports suggest that at least some individuals with insomnia may deviate from people without sleep complaints with respect to demographics , mental and physical health , childhood trauma , life events , fatigue , sleepiness , hyperarousal , hyperactivity , other sleep disorders , lifetime sleep history , chronotype , depression , anxiety , mood , quality of life , personality , happiness , worry , rumination , self-consciousness , sensitivity , dysfunctional beliefs , self-conscious emotion regulation , coping , nocturnal mentation , wake resting-state mentation , physical activity , food intake , temperature perception and hedonic evaluation . |
MS213266 | ***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: Between november 1993 and july 1995 60 patients with a common cold underwent r and omized and double-blind testing of 3 commercial nasal sprays-benzydamine , xylometazoline combined with the secretolytic S-carboxymethylcysteine , and phenylephrine combined with the antihistaminic dimethindene maleate . After prior active rhinomanometric measurement of the untreated nose , the test substance was applied . The change of nasal patency was registered after 3 and 10 minutes and then after 2 , 4 , 6 and 8 hours . At the end the patient gave a subjective evaluation of the used spray . There was no change in nasal obstruction following application of NaCl or benzydamine . Xylometazoline/S-carboxymethylcysteine ( + 87 % ) or phenylephrine/ dimethindene maleate ( + 113 % ) augmented nasal patency within minutes . Using phenylephrine/dimethindene maleate the effect lasted less than 2 hours , while after xylometazoline/S-carboxymethylcysteine decongestion lasted more than 6 hours . The patients also subjectively reported an increase in nasal patency after the use of benzydamine and placebo . But only phenylephrine/ dimethindene maleate or xylometazoline/S-carboxymethylcysteine were judged good . Using benzydamine or phenylephrine + dimethindene maleate , more side-effects ( mainly dryness and burning ) were mentioned . Considering the subjective assessment of side-effects and duration of action , as well as objective parameters , derivatives of imidazole ( oxymetazoline and xylometazoline ) are first choice in treatment of the common cold It is now possible for some allergy patients to breathe more easily and remain alert , as demonstrated by European clinical trials of a potent new antihistamine , terfenadine . The drug does not produce sedation or other adverse effects associated with older antihistamine preparations . In addition , there are no apparent contraindications for its use in adult allergy sufferers , nor have any carcinogenic , mutagenic , or teratogenic effects been seen in animals . Terfenadine , manufactured by Merrell Dow Pharmaceuticals , Inc , Cincinnati , is like other antihistamines — an H 1 receptor antagonist ; that is , it specifically blocks the chain of cellular events following the release of histamine that triggers the typical symptoms of acute and perennial rhinitis and allergic dermatitis . However , terfenadine does not affect the CNS , as indicated by a series of clinical trials reported at a Milan symposium to introduce the agent in Italy We used a rhinovirus challenge model to test the therapeutic efficacy of clemastine fumarate for reducing sneezing and nasal secretion in a double-blind , r and omized clinical trial . Clemastine fumarate ( 1.34 mg ) or placebo was administered at 8 A.M. and 8 P.M. for 4 days , beginning 24 hours , 36 hours , 48 hours , and 60 hours after viral challenge . Infected evaluable subjects who received clemastine ( n = 75 ) had reduced sneeze-severity scores compared with those who received placebo ( n = 75 ) on illness days 2 ( 0.3 vs. 0.5 ; P = .003 ) , 3 ( 0.4 vs. 0.8 ; P = .0003 ) , 4 ( 0.3 vs. 0.5 ; P = .025 ) , and 5 ( 0.1 vs. 0.3 ; P = .03 ) ; sneeze counts for infected evaluable subjects ( vs. counts for those who received placebo ) were reduced on illness days 2 ( 1.5 vs. 3.1 ; P = .01 ) , 3 ( 1.7 vs. 5.6 ; P = .0001 ) , and 5 ( 0.7 vs. 1.9 ; P = .03 ) . Infected evaluable subjects who received treatment had reduced rhinorrhea scores ( compared with those who received placebo ) on illness days 2 ( 0.7 vs. 1.0 ; P = .04 ) and 3 ( 0.6 vs. 0.9 ; P = .04 ) and had reduced nasal secretion weights on day 3 ( 3.6 g vs. 6.3 g ; P = .03 ) . Over 4 days of treatment , mean sneeze scores for infected evaluable subjects ( vs. scores for those who received placebo ) were reduced by 50 % , mean sneeze counts by 57 % , mean rhinorrhea scores by 27 % , and mean nasal secretion weights by 35 % . Other cold symptoms were unaffected by treatment . Treatment with clemastine was associated with an excess incidence of dry mouth ( 6 % ) , dry nose ( 19 % ) , and dry throat ( 17 % ) Two hundred and seventeen patients between 6 and 12 years of age suffering from acute cough took part in a r and omized , single-blind study comparing ' Pholcolix ' and ' Actifed ' Compound . No significant difference in efficacy was demonstrated but analysis of palatability components ( taste , smell , aftertaste and feeling in the mouth ) showed numerical superiority for ' Pholcolix ' for all parameters , with a high degree of significance for overall taste . ' Pholcolix ' caused significantly fewer side-effects , with ' Actifed ' Compound causing markedly more drowsiness after daytime dosage Antihistamines are widely used in common cold medications , although the role of histamine in the development of common cold symptoms is unclear and the use of antihistamines for the treatment of common cold is controversial . It is clear that antihistamines do not offer a cure for common cold but they may alleviate symptoms of sneezing and runny nose . The present study was design ed to investigate the efficacy of an antihistamine , doxylamine , on the symptoms of runny nose and sneezing associated with common cold . We conducted a r and omized double-blind study in cold sufferers . One thous and and one volunteers with cold symptoms were screened in four centres ( UK , Denmark , Belgium , Germany ) and 688 satisfied the entry criteria of the study . The main reasons for excluding subjects were a low nasal secretion weight ( secretion weight < 0.2 g , 72 % ) and a low subjective rhinorrhoea score ( 24 % ) . Volunteers were r and omized to receive either doxylamine succinate 7.5 mg by mouth four times a day up to nine doses ( n = 345 ) or placebo ( n = 343 ) . The principal measurements were prospect ively defined as runny nose and sneezing symptom scores . Data were analysed on an intention-to-treat basis , using Cochran-Mantel-Haenszel statistics controlling for baseline symptom scores . A between-group comparison showed that doxylamine-treated volunteers benefited from a significantly greater reduction in runny nose scores ( P < 0.01 ) and sneezing scores ( P < 0.001 ) , than those volunteers in the placebo group . Doxylamine therapy was well tolerated ; the incidence of unexpected side-effects was comparable with placebo . Of the expected side-effects , 13.3 % of doxylamine-treated patients reported drowsiness . The incidence of sedative effects was lower than has been reported for other commonly used first-generation antihistamines This study sought to investigate the efficacy of dextromethorphan ( DM ) , diphenhydramine ( DPH ) , and placebo ( PL ) for symptoms attributed to upper respiratory infections as determined by children , and to evaluate the concordance of perception of nocturnal symptoms between children and parents . A total of 37 children age 6 to 18 years of age were r and omized in a double-masked fashion to receive a single bedtime dose of DM , DPH , or PL . Children found no significant difference in the effect of DM , DPH , or PL for any study outcome , and responses by parents and children were significantly correlated To determine whether the cough of the common cold arises from upper respiratory stimuli and whether antihistamine-decongestant therapy is an effective treatment for this cough , we prospect ively evaluated volunteers with uncomplicated common colds in a r and omized , double-blind , placebo-controlled study . After completing a st and ardized question naire and undergoing a physical examination , throat-culturing , and pulmonary function testing , subjects took the active drug or identical-appearing placebo for 7 days while they kept a diary in which they ranked the severity of 17 symptoms for 14 days . Pulmonary function testing was repeated , on average , on Days 4 , 8 , and 14 . Forty-six percent of the variation in cough severity could be explained by throat-clearing and 47 % of the variation in throat-clearing severity by postnasal drip . FIF50 % , the only physiologic parameter that significantly correlated with cough , rose as cough severity fell . Antihistamine-decongestant therapy reduced postnasal drip and significantly decreased the severity of cough , nasal obstruction , nasal discharge , and throat-clearing during the first few days of the common cold . In addition , cough was 20 to 30 % less prevalent in the active drug group within 3 days of starting therapy . We conclude that the cough of the common cold arose from upper respiratory tract stimuli and that cough and other cardinal symptoms of the common cold were reduced with antihistamine-decongestant therapy when these symptoms were at their worst We tested the efficacy of brompheniramine maleate in a large r and omized , controlled trial of volunteers with experimental rhinovirus colds . Brompheniramine ( 12 mg ) or placebo was administered at 8:00 A.M. and 8:00 P.M. for < or = 4 days after the onset of symptoms ( 24 , 36 , or 48 hours after virus challenge ) . During the first 3 days of treatment ( the first 4 days after virus challenge ) , nasal secretion weights were lower for infected evaluable subjects receiving brompheniramine ( n = 113 ) than for controls ( day 1 : 4.3 g vs. 6.8 g ; day 2 : 4.8 g vs. 7.7 g ; and day 3 : 3.3 g vs. 5.3 g ) ( P < or = .03 ) , as were rhinorrhea scores ( day 1 : 0.6 vs. 0.8 ; day 2 : 0.5 vs. 0.8 ; and day 3 : 0.3 vs. 0.5 ) ( P < .03 ) , sneeze counts ( day 1 : 1.8 vs. 3.6 ; day 2 : 2.1 vs. 5.1 ; and day 3 : 1.3 vs. 3.3 ) ( P < or = .001 ) , and sneeze severity scores ( day 1 : 0.3 vs. 0.6 ; day 2 : 0.25 vs. 0.7 ; and day 3 : 0.2 vs. 0.4 ) ( P < .001 ) ( n = 112 ) . Cough counts were lower after day 1 of treatment for the brompheniramine group than for controls ( 4.7 vs. 7.9 ) ( P = .05 ) ( day 2 after virus challenge ) , and other symptoms were modestly reduced or were unaffected in the brompheniramine group . Total symptom scores were also lower for the brompheniramine group than for controls on treatment days 1 ( 4.8 vs. 6.0 ) ( P = .03 ) and 2 ( 4.1 vs. 5.6 ) ( days 2 and 3 after virus challenge ) ( P = .003 ) . Treatment with brompheniramine was associated with the adverse effects of somnolence ( n = 3 ) and confusion ( n = 1 ) . Brompheniramine was efficacious treatment for the sneezing , rhinorrhea , and cough associated with rhinovirus colds Limited data support the use of first-generation antihistamines for treatment of the common cold . The purpose of this study was to test the effectiveness of clemastine fumarate , a first-generation antihistamine , for treatment of sneezing and rhinorrhea associated with naturally occurring common colds . Four hundred three subjects ( 202 clemastine fumarate recipients and 201 placebo recipients ) who reported new onset ( < 24 hours ) of cold symptoms that included rhinorrhea or sneezing were studied . At baseline ( day 1 ) , the mean symptom-severity scores + /- SEM for the clemastine fumarate and placebo groups were not significantly different . The mean rhinorrhea-severity score + /- SEM was not different on day 2 ; however , on day 3 , the mean rhinorrhea-severity score + /- SEM was 1.02 + /- 0.07 for the clemastine fumarate group and 1.39 + /- 0.07 for the placebo group ( P < .001 ) . This treatment effect persisted on day 4 . A significant effect on sneezing was noted on days 2 - 4 . Sedation occurred in 14 % of the clemastine fumarate-treated subjects and 1.5 % of the placebo-treated subjects ( P < .0001 ) Abstract A r and omized , controlled , double-masked clinical trial was conducted with a combination antiviral-antimediator treatment for experimental rhinovirus colds . In all , 150 healthy men and women ( aged 18–5
Output:
| However , there was no difference between antihistamines and placebo in the mid term ( three to four days ) to long term ( six to 10 days ) .
When evaluating individual symptoms such as nasal congestion , rhinorrhoea and sneezing , there was some beneficial effect of the sedating antihistamines compared to placebo ( e.g. rhinorrhoea on day three : mean difference ( MD ) -0.23 , 95 % CI -0.39 to -0.06 on a four- or five-point severity scale ; sneezing on day three : MD -0.35 , 95 % CI -0.49 to -0.20 on a four-point severity scale ) , but this effect is clinical ly non-significant .
Adverse events such as sedation were more commonly reported with sedating antihistamines although the differences were not statistically significant .
Antihistamines have a limited short-term ( days one and two of treatment ) beneficial effect on severity of overall symptoms but not in the mid to long term .
There is no clinical ly significant effect on nasal obstruction , rhinorrhoea or sneezing .
Although side effects are more common with sedating antihistamines , the difference is not statistically significant .
There is no evidence of effectiveness of antihistamines in children |
MS213267 | ***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 Asthma is a serious problem for low-income preteens living in disadvantaged communities . Among the chronic diseases of childhood and adolescence , asthma has the highest prevalence and related health care use . School-based asthma interventions have proven successful for older and younger students , but results have not been demonstrated for those in middle school . METHODS This r and omized controlled study screened students 10 - 13 years of age in 19 middle schools in low-income communities in Detroit , Michigan . Of the 6,872 students who were screened , 1,292 students were identified with asthma . Schools were matched and r and omly assigned to Program 1 or 2 or control . Baseline , 12 , and 24 months data were collected by telephone ( parents ) , at school ( students ) and from school system records . Measures were the students ' asthma symptoms , quality of life , academic performance , self-regulation , and asthma management practice s. Data were analyzed using multiple imputation with sequential regression analysis . Mixed models and Poisson regressions were used to develop final models . RESULTS Neither program produced significant change in asthma symptoms or quality of life . One produced improved school grade s ( p = .02 ) . The other enhanced self-regulation ( p = .01 ) at 24 months . Both slowed the decline in self-regulation in undiagnosed preteens at 12 months and increased self-regulation at 24 months ( p = .04 ; p = .003 ) . CONCLUSION Programs had effects on academic performance and self-regulation capacities of students . More developmentally focused interventions may be needed for students at this transitional stage . Disruptive factors in the schools may have reduced both program impact and the potential for outcome assessment Pediatric asthma rates are reaching epidemic proportions , adversely affecting children 's quality of life , educational potential , and health care costs , especially those in the inner city . This study evaluated the effectiveness of a school-based asthma case management ( CM ) approach with medically underserved inner-city children attending Memphis City schools . Fourteen elementary schools with high rates of asthma-related hospital utilization were grouped according to school size , percentage of children with asthma enrolled , and percentage of children eligible for free or reduced-price lunch . Schools were r and omized to either a nurse CM intervention or a usual care ( UC ) condition . The CM group included 115 students ; 128 students were in the UC group . A longitudinal design was used to follow students ' progress . Students were primarily African-American children diagnosed with asthma . In CM schools , nurse case managers conducted weekly group sessions incorporating the Open Airways curriculum , followed up on students ' school absences , and coordinated students ' asthma care with families , school personnel , and medical providers . In UC schools , students received routine school nursing services . CM students had fewer school absences than their counterparts in UC schools ( mean 4.38 vs 8.18 days , respectively ) and experienced significantly fewer emergency department visits ( p < .0001 ) and fewer hospital days ( p < .05 ) than UC students . No such differences existed before program initiation . Replication and follow-up in year 2 showed continued significant improvements . School-based nurse CM can achieve significant improvements in school attendance and medical utilization OBJECTIVE To evaluate the impact of the School-Based Asthma Therapy trial on asthma symptoms among urban children with persistent asthma . DESIGN R and omized trial , with children stratified by smoke exposure in the home and r and omized to a school-based care group or a usual care control group . SETTING Rochester , New York . PARTICIPANTS Children aged 3 to 10 years with persistent asthma . INTERVENTIONS Directly observed administration of daily preventive asthma medications by school nurses ( with dose adjustments according to National Heart , Lung , and Blood Institute Expert Panel guidelines ) and a home-based environmental tobacco smoke reduction program for smoke-exposed children , using motivational interviewing . MAIN OUTCOME MEASURE Mean number of symptom-free days per 2 weeks during the peak winter season ( November-February ) , assessed by blinded interviews . RESULTS We enrolled 530 children ( 74 % participation rate ) . During the peak winter season , children receiving preventive medications through school had significantly more symptom-free days compared with children in the control group ( adjusted difference = 0.92 days per 2 weeks ; 95 % confidence interval , 0.50 - 1.33 ) and also had fewer nighttime symptoms , less rescue medication use , and fewer days with limited activity ( all P < .01 ) . Children in the treatment group also were less likely than those in the control group to have an exacerbation requiring treatment with prednisone ( 12 % vs 18 % , respectively ; relative risk = 0.64 ; 95 % confidence interval , 0.41 - 1.00 ) . Stratified analyses showed positive intervention effects even for children with smoke exposure ( n = 285 ; mean symptom-free days per 2 weeks : 11.6 for children in the treatment group vs 10.9 for those in the control group ; difference = 0.96 days per 2 weeks ; 95 % confidence interval , 0.39 - 1.52 ) . CONCLUSIONS The School-Based Asthma Therapy intervention significantly improved symptoms among urban children with persistent asthma . This program could serve as a model for improved asthma care in urban communities OBJECTIVE To test the feasibility and preliminary effectiveness of the School-Based Preventive Asthma Care Technology ( SB-PACT ) program , which includes directly observed therapy of preventive asthma medications in school facilitated by Web-based technology for systematic symptom screening , electronic report generation , and medication authorization from providers . STUDY DESIGN We conducted a pilot r and omized trial of SB-PACT versus usual care with 100 children ( aged 3 - 10 years ) from 19 inner-city schools in Rochester , New York . Outcomes were assessed longitudinally by blinded interviewers . Analyses included bivariate statistics and linear regression models , adjusting for baseline symptoms . RESULTS There were data for 99 subjects for analysis . We screened all children using the Web-based system , and 44 of 49 treatment group children received directly observed therapy as authorized by their providers . Treatment group children received preventive medications 98 % of the time they were in school . Over the school year , children in the treatment group experienced nearly 1 additional symptom-free day over 2 weeks versus the usual care group ( 11.33 vs 10.40 , P = .13 ) . Treatment children also experienced fewer nights with symptoms ( 1.68 vs 2.20 , P = .02 ) , days requiring rescue medications ( 1.66 vs 2.44 , P = .01 ) , and days absent from school due to asthma ( 0.37 vs 0.85 , P = .03 ) compared with usual care . Further , treatment children had a greater decrease in exhaled nitric oxide ( -9.62 vs -0.39 , P = .03 ) , suggesting reduction in airway inflammation . CONCLUSION The SB-PACT intervention demonstrated feasibility and improved outcomes across multiple measures in this pilot study . Future work will focus on further integration of preventive care delivery across community and primary care systems This study examines healthcare utilization over time in Bronx , New York schoolchildren with asthma who were previously identified via parent surveys in six elementary schools . Four of the schools have on-site school-based health centers ( SBHCs ) , and two do not have on-site health services ( control schools ) . At baseline , we reported an asthma prevalence of 20 % , and high rates of emergency department ( ED ) use ( 46 % ) in the previous year . To determine if asthma morbidity ( specifically , ED use , community provider use , and hospitalizations for asthma ) could be reduced by incorporating an aggressive intervention at two schools with SBHCs , we prospect ively followed children for up to 3 years . Parents were scheduled for interviews every 6 months , and were queried about their children 's use of health services for asthma in the prior 6 months . In multivariate models , children in the two intervention SBHC schools were less likely to have visited a community provider for asthma ( relative rate ratio , 0.52 ; 95 % confidence interval ( CI ) , 0.30 - 0.88 ) or an emergency department for asthma ( odds ratio , 0.44 ; 95 % CI , 0.14 - 1.38 ; P = 0.059 ) in the prior 6 months compared to children attending control schools . There was no difference in community provider use or emergency department use for asthma between children attending nonintervention SBHCs and control schools . However , school type did not affect asthma hospitalization rates , which declined in all groups . Our findings support the effectiveness of aggressive school-based asthma services provided by SBHCs to reduce asthma morbidity and complement community health services Abstract Objective : To present outcomes of an asthma self-management educational intervention delivered to children ( grade s 2–5 ) at school and to parents in a home visit . Methods : The intervention effectiveness was tested in a 12-month longitudinal study with r and omization by elementary schools into treatment and attention-control groups with 183 children who had a diagnosis of asthma . Data were collected at four time points . Change over time was examined with linear mixed models . Results : Quality of life ( QOL ) , hospitalizations , and emergency department visits improved significantly for all the children . African American and Mexican American children had worse asthma-related QOL than did White children . Asthma management behaviors , asthma self-efficacy , and coping likewise improved with girls improving significantly more than the boys . Significant improvements in inhaler skill and asthma severity were seen in the treatment group children when compared to the control group . Treatment group parents showed significant improvements in home asthma management and self-efficacy . Conclusions : The improvement in inhaler skill is an important finding for practitioners as this is a behavior that can be addressed in the clinical setting . The reduction in the treatment group ’s asthma severity scores may reflect the improvement in medication delivery as their inhaler skill improved . The differential improvement between boys and girls points to the need for testing other formats in asthma education that can address different learning styles . The individualized parent asthma education enabled the intervener to incorporate neighborhood and home environmental information thereby allowing for tailoring of parental instruction INTRODUCTION Asthma is the most prevalent chronic illness , affecting more than 7 million children younger than 17 years . Asthma has become a leading public health concern because of the dramatic rise in the incidence of this disease during the past 15 years , particularly in minority population s. This study tested a two-part intervention on selected psychosocial and health outcomes of 8- to 13-year-old inner city minority students with asthma . METHOD The intervention consisted of participation in an asthma education program ( Open Airways ) followed by 5 monthly visits with a nurse practitioner . The total sample of 52 children was composed of 28 children in the treatment group who received the intervention and 24 children who served as a control group . RESULTS Students in the treatment group scored significantly higher than the control group over time on measures of asthma knowledge , asthma self-efficacy , general self-care practice s , and asthma self-care practice s. No significant differences were found between the two groups on health outcomes . DISCUSSION A school-based intervention program can improve psychosocial outcomes for inner-city minority children with asthma . Recommendations for future research and clinical practice are discussed STUDY OBJECTIVE This study assessed the impact of a comprehensive school-based asthma program on symptoms , grade s , and school absences in children , and parents ' asthma management practice s. DESIGN R and omized controlled trial . SETTING Fourteen elementary schools in low-income neighborhoods in Detroit , MI . PARTICIPANTS Eight hundred thirty-five children with asthma in grade s 2 through 5 and their parents . INTERVENTION The intervention entailed six components for children , their parents , classmates , and school personnel to encourage and enable disease management . MEASUREMENTS AND RESULTS Parents completed telephone interviews and the schools provided data at baseline and 24 months after intervention . At follow-up , treatment children with persistent disease had significant declines in both daytime ( 14 % fewer , p < 0.0001 ) and nighttime ( 14 % fewer , p < 0.0001 ) symptoms . Among children with both mild intermittent and persistent disease , those in the treatment group had 17 % fewer daytime symptoms ( p < 0.0001 ) but 40 % more nighttime symptoms . Treatment children had higher grade s for science ( p < 0.02 ) but not reading , mathematics , or physical education . No differences in school absences for all causes between groups were noted in school records . However , parents of treatment group children reported fewer absences attributable to asthma in the previous 3 months ( 34 % fewer , p < 0.0001 ) and 12 months ( 8 % fewer , p < 0.05 ) . Parents of treatment children had higher scores ( 2.19 greater , p = 0.02 ) on an asthma management index . The program may have stimulated attention to symptoms at night by parents of children with mild intermittent disease . Overall , the intervention provided significant benefits , particularly for children with persistent asthma School-based asthma interventions delivered by nonschool staff have been successful but are limited in their reach because of the cost and effort of bringing in outside educators and their inability to establish improved communication about asthma between schools , families , and primary care providers ( PCPs ) . To address these problems , Columbia University and the New York City Department of Education and the New York City Department of Health and Mental Hygiene undertook a r and omized controlled trial to test the efficacy of a comprehensive school-based asthma program
Output:
| Direct access to school nursing and other health services , as well as disease-specific education , improved health and academic outcomes among students with CHCs . |
MS213268 | ***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: This study was performed to determine the frequency of inactivation and clinical correlates in non-small cell lung cancer ( NSCLC ) of three known tumor suppressor genes [ TSGs ; RB , MTS1/CDKN2 ( p16 ) , and p53 ] and various regions of 3p loss of heterozygosity ( LOH ) as other major potential TSG sites . Paraffin sections from 103 resected NSCLCs were analyzed for expression of pRB , p16 , and p53 by immunohistochemistry , whereas DNA from tumor and normal tissue were tested for LOH at 3p25 - 26 , 3p21 , and 3p14 . Previously published LOH data for 5q , 11p , 17q , and 18q were also available . Loss of pRB or p16 expression and overexpression of p53 were considered abnormal . The immunohistochemical and LOH data were correlated with a variety of clinical parameters including stage , age , sex , smoking history , and survival . With respect to pRB , p16 , and p53 , the tumors could be grouped into four categories : normal for all three proteins ( 21 % ) ; abnormal for pRB or p16 and normal for p53 ( 30 % ) ; normal for pRB and p16 and abnormal for p53 ( 20 % ) ; and abnormal in both pathways ( 28 % ) . Aberrant expression of pRB , p16 , p53 , and 3p LOH , either individually or in combination , was not associated with survival differences or any other clinical parameters , with the exception that pRB/pl6 abnormalities were more common in older patients ( P = 0.0005 ) . pRB and p16 expression showed a strong inverse correlation ( P = 0.002 ) , whereas there was no correlation between expression of pRB , p16 , and p53 . Abnormal expression of any of the three genes inversely correlated with K-ras codon 12 mutations ( P = 0.004 ) , but not with 3p LOH or LOH at other TSG loci . We conclude that resectable NSCLCs show distinct patterns of TSG inactivation , but that no clear clinical correlates exist either alone or in combination for pRB , p16 , p53 , and 3p abnormalities The 5-year survival rate of non-small cell lung carcinoma ( NSCLC ) has only marginally improved during the past two decades , despite advances in surgery and chemoradiotherapy . Major efforts are currently directed toward biological characterization of these tumors to define biomarkers able to add further prognostic information , thus improving new therapeutic protocol s. We analyzed the predictive relevance of the microvessel count ( MC ) , bcl-2 and p53 proteins , proliferative activity , and usual postsurgical parameters on recurrence and overall survival in a series of 70 patients with NSCLC . The expression of biological parameters ( p53 , bcl-2 , proliferative activity , and MC ) was detected using immunohistochemistry on paraffin-embedded and frozen sections from the tumors treated with surgical resection alone until relapse . In the univariate analysis , the histotype , tumor status , node status , p53 , bcl-2 , and MC have been shown to significantly affect progression and death . In the multiple logistic regression analysis , the MC ( P < 0.000001 ) , tumor status ( P < 0.005 ) , and node status ( P < 0.0002 ) influenced the overall survival while prediction of relapse was strongly revealed by tumor status ( P < 0.005 ) , nodal metastatic involvement ( P < 0.000001 ) , and the assessment of the vascular count ( P < 0.0004 ) . These data have allowed the creation of a multivariate model which may add more information on risk of recurrence and death in patients with NSCLC and can form the basis for future r and omized clinical trials This study was design ed prospect ively to evaluate the development of anti-p53 antibodies ( Abs ) in lung cancer patients in relation to their clinical outcome . Sera , derived from 125 lung cancer patients , consisting of 14 small cell lung cancers ( SCLC ) and 111 non-SCLCs ( NSCLC ) , were surveyed . The p53-null human NSCLC cell line , NCI-H1299 , transfected with a human mutant p53 gene was prepared as the source of p53 antigen for immunoblotting analyses to detect the presence of serum anti-p53 Abs . The control group included sera from 10 healthy adults and 14 patients with benign pulmonary diseases . Clinical data including staging and survival were recorded for statistical analyses . The anti-p53 Abs were found in 8 % ( 10 of 125 ) of the lung cancer patients studied ( 8.1 % of NSCLC versus 7.1 % of SCLC patients ) , whereas none of the control sera had detectable anti-p53 Abs . The presence of anti-p53 Abs was closely associated with malignant pleural effusions ( P = 0.001 ) . The p53 Ab-positive patients had a worse prognosis than the p53 Ab-negative patients ( P < 0.02 ; median survival , 20 versus 41 weeks ) . In both univariate and multivariate analyses , the tumor extension and probably the presence of anti-p53 Abs were significant predictors for cancer death . The development of anti-p53 Abs ( n = 9 ) was also a predictor for poor survival in patients with malignant effusions ( n = 51 ) . In conclusion , the presence of serum anti-p53 Abs is closely associated with malignant pleural effusions in lung cancer patients . It may serve as a negative prognostic factor for survival independent of malignant pleural effusions and tumor staging PURPOSE This study attempted to determine the prognostic value for survival of various pretreatment characteristics in patients with nonresectable non-small-cell lung cancer in the context of more than 10 years of experience of a European Cooperative Group . PATIENTS AND METHODS We included in the analysis all eligible patients ( N = 1,052 ) with advanced non-small-cell lung cancer registered onto one of seven trials conducted by the European Lung Cancer Working Party ( ELCWP ) during one decade . The patients were treated by chemotherapy regimens based on platinum derivatives . We prospect ively collected 23 variables and analyzed them by univariate and multivariate methods . RESULTS The global estimated median survival time was 29 weeks , with a 95 % confidence interval of 27 to 30 weeks . After univariate analysis , we applied two multivariate statistical techniques . In a Cox regression model , the selected explanatory variables were disease extent , Karnofsky performance status , WBC and neutrophil counts , metastatic involvement of skin , serum calcium level , age , and sex . These results were confirmed by application of recursive partitioning and amalgamation algorithms ( RECPAM ) , which led to classification of the patients into four homogeneous subgroups . CONCLUSION We confirmed by our analysis the role of well-known independent prognostic factors for survival , but also identified the effect of the neutrophil count , rarely studied , with the use of two methods : a classical Cox regression model and a RECPAM analysis . The classification of patients into the four subgroups we obtained needs to be vali date d in other series Although postoperative adjuvant therapy for non‐small cell lung cancer ( NSCLC ) had not been reported to be effective , it has been reported recently that oral administration of tegafur ( 1‐[2‐tetrahydrofuryl]‐5‐fluorouracil , FT ) may improve the postoperative prognosis . In the present paper , to examine whether p53 status affects the efficacy of FT as postoperative adjuvant chemotherapy for NSCLC , a total of 236 consecutive patients with completely resected pathologic stage I – IIIa NSCLC were retrospectively review ed . p53 status was determined by immunohistochemical staining . For all patients , the 5‐year survival rate of patients with FT administration ( FT group ) was 78.1 % , being significantly higher than that ( 69.1 % ) of patients without FT administration ( control group ) ( P=0.046 ) . For patients without immunohistochemical evidence of p53 overexpression , the 5‐year survival rate in the FT group was 87.1 % , being significantly higher than that ( 74.0 % ) in the control group ( P=0.036 ) . This demonstrates an improvement of postoperative prognosis by FT administration . On the other h and , for patients with p53 overexpression , there was no significant difference in the postoperative prognosis between the FT group and the control group ( 5‐year survival rate 63.2 % and 60.1 % , respectively ; P=0.514 ) , demonstrating that FT administration was not effective for these patients . In conclusion , p53 status may be useful for predicting the efficacy of postoperative adjuvant chemotherapy using FT . A prospect i ve r and omized study stratified by p53 status is needed to clarify the effect of postoperative FT administration Historical information and pathological material from 150 consecutive patients with localized adenocarcinoma of the lung was collected to evaluate oncogene expression of erbB-2 and p53 , and erbB-2 gene amplification . Pathological material after resection was review ed to verify histological staging , and patient follow-up was complete in all cases for at least 68 months . Immunohistochemistry of erbB-2 ( HER-2/neu ) and p53 oncogene expression was performed on two separate paraffin tumor blocks for each patient with normal lung as control . Gene amplification of erbB-2 was measured after DNA extraction from 20-micrometer sections of erbB-2-positive and -negative tumors . All analyses were blinded and included Kaplan-Meier survival estimates with Cox proportional hazards regression modeling . Two adequate blocks of tumor and normal lung were available for 138 ( 92 % ) patients . Immunohistochemical identification of expression of p53 was observed in 49 ( 37 % ) patients and erbB-2 in 17 ( 13 % ) patients . DNA dot blot analyses were performed on 17 erbB-2-positive and 13 r and omly selected erbB-2-negative tumors . There was 1 ( 6 % ) of 17 erbB-2-positve tumors with 4-fold erbB-2 gene amplification . Actual 5-year survival was 63 % and actuarial 10-year survival was 59 % for the entire population of 150 patients . Significant univariate predictors ( P < 0.05 ) of cancer death were the presence of symptoms , tumor size > 3 cm , poor differentiation , visceral pleural invasion , and p53 expression . Multivariate analysis associated symptoms and p53 expression as independent factors with decreased survival . Thus , this project examined p53 and erbB-2 expression in patients with localized adenocarcinoma and associated p53 status with survival . Multicenter collection of data should allow the development of a model of cancer recurrence in this most common lung cancer BACKGROUND Pre clinical studies in animal models have demonstrated tumor regression following intratumoral administration of an adenovirus vector containing wild-type p53 complementary DNA ( Ad-p53 ) . Therefore , in a phase I clinical trial , we administered Ad-p53 to 28 patients with non-small-cell lung cancer ( NSCLC ) whose cancers had progressed on conventional treatments . METHODS Patients received up to six , monthly intratumoral injections of Ad-p53 by use of computed tomography-guided percutaneous fine-needle injection ( 23 patients ) or bronchoscopy ( five patients ) . The doses ranged from 10(6 ) plaque-forming units ( PFU ) to 10(11 ) PFU . RESULTS Polymerase chain reaction ( PCR ) analysis showed the presence of adenovirus vector DNA in 18 ( 86 % ) of 21 patients with evaluable posttreatment biopsy specimens ; vector-specific p53 messenger RNA was detected by means of reverse transcription-PCR analysis in 12 ( 46 % ) of 26 patients . Apoptosis ( programmed cell death ) was demonstrated by increased terminal deoxynucleotide transferase-mediated biotin uridine triphosphate nick-end labeling ( TUNEL ) staining in posttreatment biopsy specimens from 11 patients . Vector-related toxicity was minimal ( National Cancer Institute 's Common Toxicity Criteria : grade 3 = one patient ; grade 4 = no patients ) in 84 courses of treatment , despite repeated injections ( up to six ) in 23 patients . Therapeutic activity in 25 evaluable patients included partial responses in two patients ( 8 % ) and disease stabilization ( range , 2 - 14 months ) in 16 patients ( 64 % ) ; the remaining seven patients ( 28 % ) exhibited disease progression . CONCLUSIONS Repeated intratumoral injections of Ad-p53 appear to be well tolerated , result in transgene expression of wild-type p53 , and seem to mediate antitumor activity in a subset of patients with advanced NSCLC Drug resistance is a major problem in patients with small cell lung cancer ; in fact , most die of resistant disease , despite an initial response . Several markers of drug resistance have been described in pre clinical models , but the mechanism of drug resistance in lung cancer patients remains unknown . The objective of this study was to evaluate the role of the expression of a number of markers of drug resistance , proliferation , and apoptosis in relation to response to chemotherapy and survival in patients with small cell lung cancer . Tumor sample s were derived from 93 previously untreated patients who were r and om
Output:
| In NSCLC , Bcl-2 expression was associated with a better prognosis .
The data on Bcl-2 expression in small cell lung cancer were insufficient to assess its prognostic value |
MS213269 | ***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 Treatment with long-acting injectable risperidone was evaluated in young adults likely to be in the early stages of schizophrenia or schizoaffective disorder . METHOD An open-label 50-week trial included young adults ( men aged 18 - 25 years and women aged 18 - 30 years ) . RESULTS Sixty-six young adults received at least 1 injection of long-acting risperidone ( 25 or 50 mg ) every two weeks ; 64 % of the patients completed the 50-week trial . A mode dose of 25 mg/14 days was received by 23 patients and 50 mg/14 days by 43 patients . Mean PANSS scores improved significantly from baseline at each time point , with 64 % of the patients showing clinical improvement ( > or=20 % reduction in PANSS total scores ) at endpoint . Patient-rated quality of life ( SF-36 scores ) improved and patients ' attitudes toward the medication were positive ( DAI scores ) . Severity of movement disorders ( ESRS ) and injection-site pain ratings were low throughout the trial . Results were similar in the population of other ( older ) patients . CONCLUSIONS Long-acting risperidone was associated with clinical benefits in stable young adults with early schizophrenia or schizoaffective illness The pharmacokinetics and tolerability of long-acting risperidone ( Risperdal Consta ) were evaluated in a multicenter , prospect i ve , open-label , 15-week study of 86 patients with schizophrenia . Subjects stabilized on 2 , 4 or 6 mg of oral risperidone once daily for at least 4 weeks were assigned to receive i.m . injections of 25 , 50 or 75 mg of risperidone , respectively , every 2 weeks for 10 weeks . The 90 % confidence intervals for the i.m./oral ratios of the mean steady-state plasma-AUC , corrected for dosing interval , and of the average plasma concentration of the active moiety ( risperidone plus 9-hydroxyrisperidone ) were within the range of 80 - 125 % , indicating bioequivalence of the i.m . and oral formulations . However , mean steady-state peak concentrations of the active moiety were 25 - 32 % lower with i.m . than oral dosing ( P < 0.05 ) and fluctuations in plasma active-moiety levels were 32 - 42 % lower with the i.m . than oral regimen . Symptoms of schizophrenia continued to improve after switching from oral to i.m . dosing . Long-acting risperidone was well tolerated locally and systematic ally . Although overall bioequivalence of the two formulations was established , the differences in pharmacokinetic profiles between the two formulations indicate potential benefits for long-acting risperidone BACKGROUND The extent to which antipsychotics improve patients ' well-being is uncertain . AIMS To examine psychopathology and patient-rated functioning and well-being in patients treated with risperidone . METHOD In a 1-year , open-label , international multicentre trial of long-acting risperidone in 615 stable adult patients with schizophrenia , self-rated functioning and well-being were measured every 3 months using the Short Form 36-item question naire ( SF-36 ) . Psychopathology was quantified using the Positive and Negative Syndrome Scale ( PANSS ) . RESULTS Significant improvements were found on the SF-36 mental component summary score and vitality and social functioning scales . PANSS and mental component summary scores were moderately correlated . CONCLUSIONS Patient-reported functioning and well-being appear to differ from investigator-rated psychotic symptoms . Patient-rated well-being should be assessed with symptoms to help measure treatment outcomes BACKGROUND The use of risperidone long-acting injection ( RLAI ) is reasonably well supported by controlled studies . Little is known about treatment outcomes in patients receiving RLAI in clinical practice . METHOD All prescribers in the South London and Maudsley Trust , London , United Kingdom , were informed that RLAI could be ordered for suitable patients with a DSM-IV diagnosis of schizophrenia or schizo-affective disorder : those known to be noncompliant with oral atypical antipsychotics and those intolerant of the adverse effects of conventional depot antipsychotics . Prescribers provided treatment and clinical progress data at the time of each prescription . Data collected included reason for prescribing RLAI , Clinical Global Impressions scale ( CGI ) score , inpatient or out-patient status , and details of all medications prescribed . All treatment discontinuations were investigated . The study was conducted from August 2002 to August 2003 . RESULTS Outcome could be determined for 100 subjects . Seventy-nine subjects ( 79 % ) were hospitalized when RLAI was initially prescribed . Mean duration of stay before RLAI initiation was 97 days ( range , 0 - 1492 days ) . Most subjects were switched to RLAI from oral atypical ( 58 % ) or conventional depot ( 28 % ) antipsychotics . The main reason given for prescribing RLAI was poor patient acceptability of previous treatments ( 79 % ) . Overall , 51 % of the subjects discontinued RLAI . The main reason for discontinuation was lack of effect ( 24 subjects ) . No patient-related factor predicted outcome . CGI scores improved from a mean of 4.7 to 3.6 over the study period ( p < .001 ) . Overall , 61 subjects ( 61 % ) showed an improvement in CGI scores between baseline and endpoint . Antipsychotic coprescriptions were reduced from 71 % of subjects to 8 % . In completers , 23 ( 61 % ) of 38 subjects beginning RLAI as in patients were discharged . The modal dose of RLAI was 25 mg every 2 weeks . CONCLUSION RLAI was moderately effective in clinical practice as judged by attrition from treatment . CGI score changes and discharge rates also suggest moderate effectiveness . RLAI was well tolerated . Antipsychotic coprescription was infrequent OBJECTIVE This study examined the effects of 2 doses of long-acting risperidone injection in patients with schizophrenia or schizoaffective disorder . METHOD This 52-week , prospect i ve , r and omized , double-blind , multicenter , international study included clinical ly stable out patients with schizophrenia or schizoaffective disorder ( DSM-IV criteria ) . Setting s included physicians ' offices and clinics . Patients received a fixed dose of long-acting risperidone ( 25 or 50 mg ) every 2 weeks . Primary outcome was time to relapse , defined as either re-hospitalization or other exacerbation criteria . Other assessment s included the Positive and Negative Syndrome Scale , Clinical Global Impressions-Severity of Illness scale , and functional and quality -of-life measures . Safety was assessed via treatment-emergent adverse events , laboratory tests , and movement disorder rating scales . Data were collected from December 2002 to September 2004 . RESULTS A total of 324 patients were r and omized to 25 mg ( N = 163 ) or 50 mg ( N = 161 ) of long-acting risperidone . Time to relapse was comparable ( p = .131 ) for both groups . Projected median time to relapse was 161.8 weeks ( 95 % CI = 103.0 to 254.2 ) with 25 mg and 259.0 weeks ( 95 % CI = 153.6 to 436.8 ) with 50 mg . One-year incidences of relapse were 21.6 % ( N = 35 ) and 14.9 % ( N = 24 ) , respectively ( p = .059 ) . Psychiatric hospitalization was the reason for relapse for 16 ( 10 % ) in the 25-mg group and 10 ( 6 % ) in the 50-mg group . Patients experienced statistically significant but modest improvements at endpoint in most measures ( i.e. , psychotic symptoms , functioning , movement disorder severity ) with both doses , with no significant between-group differences . CONCLUSION In this 1-year study , long-acting risperidone was associated with low relapse and rehospitalization rates , indicating that doses of 25 to 50 mg are appropriate for long-term treatment in schizophrenia Long-acting injectable antipsychotic formulations of conventional antipsychotics were developed to address the problem of partial adherence among patients with schizophrenia . Injection site pain , other skin reactions and patient satisfaction with treatment were assessed in two large , multicentre studies of long-acting injectable risperidone ( Risperdal CONSTA ™ , Janssen Pharmaceutica Products , Titusville , New Jersey , USA ) , the first available long-acting atypical antipsychotic agent . Patients rated injection site pain using a 100-mm Visual Analogue Scale ( VAS ) , and investigators rated injection site pain , redness , swelling and in duration . Patient satisfaction with treatment was assessed with the Drug Attitude Inventory ( DAI ) . VAS pain ratings were low at all visits across all doses in both studies , and decreased from first to final injection . In the 12-week , double-blind study , mean±SD VAS scores at the first and final injections were 15.6±20.7 and 12.5±18.3 for placebo-treated patients , and 11.8±14.4 ( first ) and 10.0±12.4 ( final ) for 25 mg ; 16.3±21.9 ( first ) and 13.6±21.7 ( final ) for 50 mg ; and 16.0±17.9 ( first ) and 9.6±16.0 ( final , P<0.01 ) for 75 mg of long-acting risperidone . Mean VAS scores in the 50-week , open-label study at the first and final injection were : 17.9±22.2 ( first ) and 9.5±16.7 ( final , P<0.0001 ) for 25 mg ; 18.1±19.7 ( first ) and 10.4±14.8 ( final , P<0.0001 ) for 50 mg ; and 18.5±21.6 ( first ) and 13.6±19.9 ( final , P=0.0001 ) for 75 mg of long-acting risperidone . Overall , there was no or minimal injection site pain and skin reactions were rare . Mean DAI ratings were available for the 50-week study and indicated high patient satisfaction throughout the trial ( baseline=7.30 ; endpoint=7.70 ; P<0.0001 versus baseline ) . These findings may positively affect patient and clinician attitudes towards long-term therapy with long-acting injectable risperidone OBJECTIVE The authors assessed the efficacy and safety of the first long-acting atypical antipsychotic ( long-acting injectable risperidone ) in patients with schizophrenia . METHOD In a 12-week , multicenter , double-blind , r and omized study , patients received intramuscular injections every 2 weeks of placebo or long-acting risperidone ( 25 mg , 50 mg , or 75 mg ) . The primary measure of efficacy was the change in total score on the Positive and Negative Syndrome Scale . RESULTS Of the 554 patients who were enrolled , 400 entered the double-blind study , and 370 received at least one postbaseline assessment . Mean changes in score of -6.2 , -8.5 , and -7.4 on the Positive and Negative Syndrome Scale were seen at endpoint for the 25- , 50- , and 75-mg risperidone groups , respectively ; all three change scores were significantly different from that seen with placebo ( + 2.6 ) . Improvements in positive and negative symptoms were also significantly greater in patients receiving risperidone . Long-acting risperidone was well tolerated . Adverse events related to extrapyramidal symptoms were spontaneously reported by 13 % of patients receiving placebo and 10 % of patients in the 25-mg risperidone group , with higher rates in the 50-mg and 75-mg groups . Severity of extrapyramidal symptoms was mild at baseline and throughout the trial in each treatment group . Mean weight changes were small in the 25- , 50- , and 75-mg risperidone groups ( 0.5 kg , 1.2 kg , and 1.9 kg , respectively ) . Injection site pain was rated as low by the patients , consistent with the investigators ' pain ratings . CONCLUSIONS Long-acting injectable risperidone was efficacious and well tolerated and provides both clinicians and patients with a new mode of treatment that can improve the outcome of long-term therapy The maintained antipsychotic efficacy of risperidone long-acting injectable ( RLAI ) was investigated in patients with schizophrenia or other psychoses who were transitioned directly from their previous antipsychotic medication . Patients symptomatically stable , but considered to require a treatment change , received 25 mg of RLAI ( increased to 37.5 or 50 mg , if necessary ) every 2 weeks for 6 months . Assessment s included Positive and Negative Syndrome Scale ( PANSS ) , Clinical
Output:
| RESULTS Risperidone long-acting injection was the first licensed SGA-LAI compound and is effective in the long-term management of schizophrenia , with a safety profile similar to that of oral risperidone .
In terms of efficacy , at injection intervals of up to 4 weeks it appears comparable to oral olanzapine , although the potential for ; post-injection syndrome ' ( delirium ) calls for additional safety considerations . |
MS213270 | ***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 describe the design and baseline data of an educational intervention targeting predominantly Mexican American middle school students and their parents in an effort to improve stroke awareness . Increasing awareness in this group may increase the number of patients eligible for acute stroke treatment by encouraging emergency medical services ( EMS ) activation . METHODS This is a prospect i ve , r and omized study in which six middle schools were r and omly assigned to receive a stroke education program or the st and ard health class . Primary outcome measures are the percentage of students and parents who recognize stroke symptoms and express the intent to activate EMS upon recognition of these findings . RESULTS A total of 547 students ( 271 control , 276 intervention ) and 484 parents ( 231 control , 253 intervention ) have been enrolled . Pretests were administered . The intervention has been successfully carried out in the parent and student cohorts over a three-year period . Posttests and persistence test results are pending . CONCLUSION Implementing a school-based stroke education initiative is feasible . Followup testing will demonstrate whether this educational initiative translates into a measurable and persistent improvement in stroke knowledge and behavioral intent to activate EMS upon recognition of stroke symptoms Background and Purpose — Reduction in the risk of stroke and increase in the speed of hospital presentation after the onset of stroke both depend on the level of knowledge of stroke in the general population . The aim of the present study was to assess baseline knowledge regarding stroke risk factors , symptoms , treatment , and information re sources . Methods — A community-based telephone interview survey was conducted in the Newcastle urban area in Australia . A total of 1278 potential participants between the ages of 18 to 80 were selected at r and om from an electronic telephone directory . A trained telephone interviewer conducted a telephone survey using the Computer-Assisted Telephone Interviewing ( CATI ) program . Results — A total of 822 participants completed the telephone interview . Six hundred three participants ( 73.4 % ) correctly identified the brain as the affected organ in stroke . The most common risk factors for stroke identified by respondents were smoking ( identified by 324 [ 39.4 % ] ) and stress ( identified by 277 [ 33.7 % ] ) . The most common warning sign of stroke described by respondents was “ blurred and double vision or loss of vision in an eye , ” listed by 198 ( 24.1 % ) . A total of 626 ( 76.2 % ) respondents correctly listed ≥1 established stroke risk factor , but only 409 ( 49.8 % ) respondents correctly listed ≥1 warning sign . Conclusions — The level of knowledge in the community of established stroke risk factors , warning signs , and treatment as indicated by this survey suggests that a community-based education program to increase public knowledge of stroke may contribute to reducing the risk of stroke and to increasing the speed of hospital presentation after the onset of stroke Background and Purpose — This study compared the psychometric properties of 3 clinical balance measures , the Berg Balance Scale ( BBS ) , the Balance subscale of the Fugl-Meyer test ( FM-B ) , and the Postural Assessment Scale for Stroke Patients ( PASS ) , in stroke patients with a broad range of neurological and functional impairment from the acute stage up to 180 days after onset . Methods — One hundred twenty-three stroke patients were followed up prospect ively with the 3 balance measures 14 , 30 , 90 , and 180 days after stroke onset ( DAS ) . Reliability ( interrater reliability and internal consistency ) and validity ( concurrent validity , convergent validity , and predictive validity ) of each measure were examined . A comparison of the responsiveness of each of the 3 measures was made on the basis of the entire group of patients and 3 separate groups classified by degree of neurological severity . Results — The FM-B and BBS showed a significant floor or ceiling effect at some DAS points , whereas the PASS did not show these effects . The BBS , FM-B , and PASS all had good reliability and validity for patients at different recovery stages after stroke . The results of effect size demonstrated fair to good responsiveness of all 3 measures within the first 90 DAS but , as expected , only a low level of responsiveness at 90 to 180 DAS . The PASS was more responsive to changes in severe stroke patients at the earliest period after stroke onset , 14 to 30 DAS . Conclusions — All 3 measures tested showed very acceptable levels of reliability , validity , and responsiveness for both clinicians and research ers . The PASS showed slightly better psychometric characteristics than the other 2 measures Background and Purpose — Previous overt stroke and sub clinical stroke are frequent in patients with stroke ; yet , their clinical significance and effects on stroke outcome are not clear . We studied the burden and outcome after acute ischemic stroke by prevalent ischemic brain disease in a national registry of hospitalized patients with acute stroke . Methods — Patients with ischemic stroke in the National Acute Stroke Israeli prospect i ve hospital-based registry ( February to March 2004 , March to April 2007 , and April to May 2010 ) with information on previous overt stroke and sub clinical stroke per computed tomography/MRI ( n=3757 ) were included . Of them , a sub sample ( n=787 ) was followed up at 3 months . Logistic regression models were computed for outcomes in patients with prior overt stroke or sub clinical stroke , compared with patients with first stroke , adjusting for age , sex , vascular risk factors , stroke severity , and clinical classification . Results — Two-thirds of patients had a prior overt stroke or sub clinical stroke . Death rates were similar for patients with and without prior stroke . Adjusted odds ratios ( OR ; 95 % confidence interval [ CI ] ) for disability were increased for patients with prior overt stroke ( OR , 1.31 ; 95 % CI , 1.03–1.66 ) and sub clinical stroke ( OR , 1.45 ; 95 % CI , 1.16–1.82 ) . Relative odds of Barthel Index ⩽60 for patients with prior overt stroke ( OR , 2.04 ; 95 % CI , 1.14–3.68 ) and with prior sub clinical stroke ( OR , 2.04 ; 95 % CI , 1.15–3.64 ) were twice higher than for patients with a first stroke . ORs for dependency were significantly increased for patients with prior overt stroke ( OR , 1.95 ; 95 % CI , 1.19–3.20 ) but not for those with sub clinical stroke ( OR , 1.36 ; 95 % CI , 0.84–2.19 ) . Conclusions — In our national cohort of patients with acute ischemic stroke , nearly two thirds had a prior overt stroke or sub clinical stroke . Risk of poor functional outcomes was increased for patients with prior stroke , both overt and sub clinical BACKGROUND The ideal method of providing stroke patients with information has not been established . OBJECTIVES To evaluate the effectiveness of providing stroke patients with computer-generated tailored written information . DESIGN R and omised controlled trial with blinded assessor . SETTING Acute stroke unit . PARTICIPANTS 138 stroke patients . METHODS Patients were r and omised to receive either computer-generated tailored written information about stroke or generic written information while in hospital . Three months following discharge , a blinded assessor evaluated the outcomes of knowledge about stroke , self-efficacy ( Self-Efficacy to Perform Self-Management Behaviours Scale ) , anxiety and depression ( Hospital Anxiety and Depression ( HAD ) Scale ) , perceived health status ( COOP charts ) , satisfaction with content and presentation of the written information received ( separate 10-point visual analogue scale for content and presentation ) , and desire for additional information . RESULTS Complete data were obtained for 133 ( 96.4 % ) patients . Patients in the intervention group were significantly more satisfied with the content ( difference on a 10-point visual analogue scale was 1 , 95 % confidence interval 0.4 to 1.7 , P = 0.003 ) and presentation ( difference on a 10-point visual analogue scale was 1.2 , 95 % confidence interval 0.6 to 1.9 , P < 0.001 ) . Significantly , fewer patients in the intervention group desired additional information about stroke at follow-up than patients in the control group ( 4.5 % versus 32.8 % ; P < 0.001 ) . Anxiety change scores improved slightly more in favour of the control group ( 1.4 difference on the HAD subscale , 95 % confidence interval 0.2 to 2.8 , P = 0.03 ) . No significant differences between the groups were observed for any of the other outcome measures . INTERPRETATION Providing stroke patients with computer-generated tailored written information improved satisfaction with the information that was received and was more effective in meeting patients ' informational needs than non-tailored information , but had no effect on knowledge about stroke , self-efficacy , depression , or perceived health status Objective : To determine levels of satisfaction with information and advice received about stroke disease and relevant issues by community-dwelling stroke survivors . Design : An interview question naire survey . Setting : A family health services authority area in northern Engl and . Subjects : Stroke survivors identified by a valid screening question naire from a stratified r and om sample of 2000 subjects aged 45 years and over . Main outcome measure : Proportion of subjects interviewed responding positively to the question ' Do you think you have received enough advice and information on ... ? ' eighteen topics considered relevant to stroke survivors . Results : The screening process identified 116 stroke survivors , of whom 76 agreed to be interviewed . The majority ( > 80 % ) of patients were satisfied with information and advice received on lifestyle and health promotion issues , incontinence and their current treatment . However , satisfaction was poor for the areas of stroke disease in general , its effects , available services , and legal and financial affairs ( range , 28 - 75 % satisfied ) . Conclusion : Deficits in the provision of adequate information and advice to stroke patients on relevant issues have been identified in this study of a representative sample of community-dwelling stroke survivors . These deficits need to be addressed by those providing care for stroke patients in order to improve patient satisfaction Background and Purpose — Increased knowledge of stroke risk factors in the general population may lead to improved prevention of stroke . The objective of the present study was to assess knowledge of stroke risk factors and to determine factors associated with knowledge . Methods — In a population -based survey , we sent a question naire to r and omly selected residents in Berlin who were ≥50 years of age enquiring about knowledge of stroke risk factors . Knowledge was assessed in an open-ended question . In addition , we enquired about the source of participants ' information . Sociodemographic factors , including age , sex , educational level , and nationality , were also assessed . Results — A total of 28 090 of 75 720 residents ( response rate , 37 % ) responded to the question naire . Of all respondents , 68 % were able to name ≥1 correct stroke risk factor , and 13 % named 4 correct risk factors . The majority of respondents named mass media as source of information ( 82 % ) , followed by family/friends ( 45 % ) and by general physicians ( 20 % ) . In multivariable analysis , increased knowledge of stroke risk factors was significantly associated with younger age , a higher educational level , not living alone , a German nationality , and having received any information about stroke during the last year . However , characteristics of respondents using the respective sources of information varied significantly . Conclusions — Mass media was most frequently named as a source of information about stroke risk factors . Source of information used varied according to population characteristics . Health education programs should take this into account and be adapted accordingly Background and Purpose — Quality of life ( QoL ) is important to stroke survivors yet is often recorded as a secondary measure in acute stroke r and omized controlled trials . We examined whether commonly used stroke outcome measures captured aspects of QoL. Methods — We examined primary outcomes by National Institutes of Health Stroke Scale ( NIHSS ) , Barthel Index ( BI ) and modified Rankin Scale ( mRS ) , and QoL by Stroke Impact Scale ( SIS ) and European Quality of Life Scale ( EQ-5D ) from the Virtual International Stroke Trials Archive ( VISTA ) . Using Spearman correlations and logistic regression , we described the relationships between QoL mRS , NIHSS , and BI at 3 months , stratified by respondent ( patient or proxy ) . Using & khgr;2 analyses , we examined the mismatch between good primary outcome ( mRS ⩽1 , NIHSS ⩽5 , or BI ≥95 ) but poor QoL , and poor primary outcome ( mRS ≥3 , NIHSS ≥20 , or BI ⩽60 ) but good QoL. Results — Patient-assessed QoL had a stronger association with mRS ( EQ-5D weighted score n=2987 , P<0.0001 , r=−0.7 , r2=0.53 ; SIS recovery n=2970 , P<0.0001 , r=−0.71 , r2=0.52 ) . Proxy responses had a stronger association with BI ( EQ-5D weighted score n=837 , P<0.0001 , r=0.78 , r2=0.63 ; SIS recovery n=867 , P<0.0001 , r=0.68 , r2=0.48 ) . mRS explained more of the variation in QoL ( EQ-5D weighted score=53 % , recovery by SIS v3.0=52 % ) than NIHSS or BI and result ed in fewer mismatches between good primary outcome and poor QoL ( P<0.0001 , EQ-5D weighted score=8.5 % ; SIS recovery=10 % ; SIS-16=4.4 % ) . Conclusions — The mRS seemed to align closely with stroke survivors ’ interests , capturing more information on QoL than either NIHSS or BI . This further supports its recommendation as a primary outcome measure in
Output:
| Conclusions : Our study revealed that current available tools are not sufficiently able to accurately and reliably assess SK to promote stroke prevention and management . |
MS213271 | ***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 Mammographic breast density is a strong risk factor for breast cancer . Tamoxifen , which reduces the risk of breast cancer in women at high risk , also reduces mammographic breast density . However , it is not known if tamoxifen-induced reductions in breast density can be used to identify women who will benefit the most from prophylactic treatment with this drug . METHODS We conducted a nested case-control study within the first International Breast Cancer Intervention Study , a r and omized prevention trial of tamoxifen vs placebo . Mammographic breast density was assessed visually and expressed as a percentage of the total breast area in 5 % increments . Case subjects were 123 women diagnosed with breast cancer at or after their first follow-up mammogram , which took place 12 - 18 months after trial entry , and control subjects were 942 women without breast cancer . Multivariable logistic regression was used to adjust for other risk factors . All statistical tests were two-sided . RESULTS In the tamoxifen arm , 46 % of women had a 10 % or greater reduction in breast density at their 12- to 18-month mammogram . Compared with all women in the placebo group , women in the tamoxifen group who experienced a 10 % or greater reduction in breast density had 63 % reduction in breast cancer risk ( odds ratio = 0.37 , 95 % confidence interval = 0.20 to 0.69 , P = .002 ) , whereas those who took tamoxifen but experienced less than a 10 % reduction in breast density had no risk reduction ( odds ratio = 1.13 , 95 % confidence interval = 0.72 to 1.77 , P = .60 ) . In the placebo arm , there was no statistically significant difference in breast cancer risk between subjects who experienced less than a 10 % reduction in mammographic density and subjects who experienced a greater reduction . CONCLUSION The 12- to 18-month change in mammographic breast density is an excellent predictor of response to tamoxifen in the preventive setting CONTEXT There are few data directly comparing the effects of physical activity and body weight on cardiovascular biomarkers . OBJECTIVE To examine the association of physical activity and body mass index ( BMI , defined as weight in kilograms divided by the square of height in meters ) alone and in combination with cardiovascular biomarkers . DESIGN , SETTING , AND PARTICIPANTS Cross-sectional analysis of 27,158 apparently healthy US women ( mean age , 54.7 years ) at the time of enrollment ( 1992 - 1995 ) in the Women 's Health Study , a r and omized , double-blind , placebo-controlled trial of low-dose aspirin and vitamin E in the primary prevention of cardiovascular disease and cancer . MAIN OUTCOME MEASURES The association of physical activity and BMI with high-sensitivity C-reactive protein ( CRP ) , fibrinogen , soluble intracellular adhesion molecule 1 ( ICAM-1 ) , homocysteine , low- and high-density lipoprotein ( LDL and HDL ) cholesterol , total cholesterol , apolipoprotein A-1 and B100 , lipoprotein(a ) , and creatinine . RESULTS Lower levels of physical activity and higher levels of BMI were independently associated ( P for trend < .001 ) with adverse levels of nearly all lipid and inflammatory biomarkers . High BMI showed stronger associations with these biomarkers than physical inactivity . For example , using the reference group of physically active , normal weight women ( energy expenditure > or = 1000 kcal/week ; BMI , 18.5 - 24.9 ) and adjusting for age , race , smoking , blood pressure , diabetes , menopausal status , and hormone use , the odds ratios ( 95 % confidence intervals [ CIs ] ) for having CRP > 3 mg/L were : for inactive , normal weight women 1.26 ( 1.15 - 1.37 ) ; active , overweight 2.68 ( 2.41 - 2.98 ) ; inactive , overweight 3.11 ( 2.84 - 3.41 ) ; active , obese 8.25 ( 7.15 - 9.51 ) ; and inactive , obese 9.86 ( 8.84 - 10.99 ) . In similar analyses , the odds ratios ( 95 % CIs ) for having HDL cholesterol < 50 mg/dL were 1.20 ( 1.11 - 1.30 ) ; 2.25 ( 2.04 - 2.49 ) ; 2.62 ( 2.41 - 2.85 ) ; 4.21 ( 3.68 - 4.81 ) ; and 5.27 ( 4.77 - 5.84 ) , respectively , and for having apolipoprotein B100 > 120 mg/dL they were 1.21 ( 1.11 - 1.33 ) ; 1.86 ( 1.66 - 2.08 ) ; 2.06 ( 1.88 - 2.67 ) ; 2.35 ( 2.04 - 2.70 ) ; and 2.33 ( 2.09 - 2.59 ) . Fibrinogen , ICAM-1 , apolipoprotein A1 , total cholesterol , and LDL cholesterol showed similar associations . By contrast , homocysteine , lipoprotein ( a ) , and creatinine showed weak or nonsignificant associations . CONCLUSIONS High BMI was more strongly related to adverse cardiovascular biomarker levels than physical inactivity . However , within BMI categories , physical activity was generally associated with more favorable cardiovascular biomarker levels than inactivity Mammographic density is a strong risk factor for breast cancer ; however the mechanism that underlies this association is unclear . We hypothesized that measures of energy balance early in life and in adulthood may be associated with mammographic density . We conducted a cross-sectional analysis of 1,398 women in the Nurses ’ Health Study to examine associations between physical activity , childhood and current body fatness , weight gain from age 18 years to present and mammographic density . Percent mammographic density was measured from digitized mammograms by a computer-assisted method . Demographic and lifestyle data were obtained from prospect ively collected question naires . For all analyses , subjects were stratified into three groups : premenopausal women , postmenopausal women not currently taking hormones , and postmenopausal women currently taking hormones . Childhood body fatness was inversely associated with mammographic density . The correlations ranged from −0.15 to −0.19 in the three strata of women ( P ≤ 0.001 ) . The difference in mean percent mammographic density between the leanest and heaviest body types ranged from 6.2 to 9.9 % . Similarly , adult body fatness was inversely associated with percent mammographic density . The correlations ranged from −0.41 to −0.48 in the three strata of women ( P < 0.0001 ) . The difference in mean percent mammographic density between the leanest and heaviest body types ranged from 22.3 to 35.1 % . Weight gain from age 18 was also inversely associated with mammographic density . There was no association between recent physical activity and mammographic density . These findings indicate that childhood and adult body fatness and weight change from age 18 are inversely associated with mammographic density The ability to detect small tumors is impaired in dense mammograms . It has been suggested that the sensitivity of mammograms could be lower in mammograms obtained during the luteal phase of the menstrual cycle . We examined the change in mammographic density from the follicular to the luteal phase of the menstrual cycle in 11 women . Although the average increase in densities was quite small ( 1.2 % ; P = 0.08 ) , six women had clinical ly significant increases ( 1.4 - 7.8 % ) , suggesting that premenopausal women should undergo mammographic examinations in the follicular part of the menstrual cycle The authors examined sources of variance in self-reported physical activity in a cohort of healthy adults ( n = 580 ) from Worcester , Massachusetts ( the Seasonal Variation of Blood Cholesterol Study , 1994 - 1998 ) . Fifteen 24-hour physical activity recalls of total , occupational , and nonoccupational activity ( metabolic equivalent-hours/day ) were obtained over 12 months . R and om effects models were employed to estimate variance components for subject , season , day of the week , and residual error , from which the number of days of assessment required to achieve 80 % reliability was estimated . The largest proportional source of variance in total and nonoccupational activity was within-subject variance ( 50 - 60 % of the total ) . Differences between subjects accounted for 20 - 30 % of the overall variance in total activity , and seasonal and day-of-the-week effects accounted for 6 % and 15 % , respectively . For total activity , 7 - 10 days of assessment in men and 14 - 21 days of assessment in women were required to achieve 80 % reliability . For nonoccupational activity , 21 - 28 days of assessment were required . This study is among the first to have examined the sources of variance in daily physical activity levels in a large population of adults using 24-hour physical activity recall . These findings provide insight for underst and ing the strengths and limitations of short term and long term physical activity assessment s employed in epidemiologic studies Physical activity has been associated with a reduced risk of breast cancer . However , little is known about the association between recreational physical activity and mammographic density . We examined the association between recreational physical activity and mammographic density using mammograms from 375 white and African American women without breast cancer who served as controls in the Los Angeles component of the Women 's Contraceptive and Reproductive Experiences Study . We used data from 5 time periods of activity in the statistical analysis : from menarche to mammogram screening , the first 3 and 10 years after menarche , the most recent 10 years and the 3 years prior to mammogram screening . Lifetime history of recreational physical activity was obtained through interviews using a structured question naire . We used multiple linear regression to estimate least-squared mean values of absolute and percent mammographic density within categories of physical activity . Overall , we found no statistically significant evidence that physical activity reduced absolute or percent mammographic density . We observed a modest positive association between lifetime physical activity and percent mammographic density ( p for trend = 0.04 ) among younger women , and between recent physical activity and percent density among both younger ( < 50 years , p for trend = 0.09 ) and older ( > or = 50 years , p for trend = 0.06 ) women , but these associations diminished after additionally adjusting for body mass index ( BMI ) ( all p > or = 0.10 ) . However , among women younger than 50 years , we found some evidence for a protective effect of " strenuous " physical activity in the first 3 years after menarche , with a nonstatistically significant inverse association with both absolute ( p for trend = 0.07 ) and percent ( p for trend = 0.08 ) mammographic density after adjustment for BMI . Our results suggest that physical activity is not a strong predictor of mammographic density Background : We have examined the relationships between the measured properties of breast tissue and mammographic density and other risk factors for breast cancer , using breast tissue obtained at forensic autopsy and not selected for the presence of abnormalities . Methods : We used r and omly selected tissue blocks taken from breast tissue slices obtained by s.c . mastectomy at the time of forensic autopsy to measure histologic features using quantitative microscopy . The proportions of the biopsy occupied by cells ( estimated by nuclear area ) , gl and ular structures , and collagen were determined . These measurements were examined in relation to the percent density in the faxitron image of the tissue slice from which the biopsy was taken and other risk factors for breast cancer . Results : The percent mammographic density was associated with the proportion of the area of the biopsy occupied by nuclei , both epithelial and nonepithelial , and by collagen and the area of gl and ular structures . Several other risk factors for breast cancer , notably body weight , parity , and number of births , and menopausal status , that are associated with variations in mammographic density , were also associated with differences in one or more of these tissue features . Conclusion : All risk factors for breast cancer must ultimately exert their influence by an effect on the breast , and these findings suggest that , for some risk factors , this influence includes an effect on the number of cells and the quantity of collagen Background : The Alberta Physical Activity and Breast Cancer Prevention ( ALPHA ) Trial examined the influence of aerobic exercise on biological factors that are associated with breast cancer risk . Mammographic density , a secondary outcome , is reported here . Methods : The ALPHA Trial was a parallel group r and omized controlled trial conducted between May 2003 and July 2007 . Postmenopausal , sedentary women ages 50 to 74 years ( n = 320 ) were evenly r and omized to aerobic exercise ( 45 minutes , 5 days per week ) or control ( usual life-style ) for 1 year . Dense fibrogl and ular tissue and nondense fatty tissue were measured from mammograms at baseline and 1 year using computer-assisted thresholding software for area measurements and a new technique that relies on the calibration of mammography units with a tissue-equivalent phantom for volumetric measurements . Results : Nondense volume decreased in the exercise group relative to the control group ( difference between groups = −38.5 cm3 ; 95 % confidence interval ,
Output:
| Given the strength of the relationship between physical activity and breast cancer and the null findings of this review , it is unlikely that the effect of physical activity is mediated through an effect on breast density |
MS213272 | ***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 CONTEXT Cervical total disc replacement ( TDR ) is intended to address radicular pain and preserve functional motion between two vertebral bodies in patients with symptomatic cervical disc disease ( SCDD ) . PURPOSE The purpose of this trial is to compare the safety and efficacy of cervical TDR , ProDisc-C ( Synthes Spine Company , L.P. , West Chester , PA ) , to anterior cervical discectomy and fusion ( ACDF ) surgery for the treatment of one-level SCDD between C3 and C7 . STUDY DESIGN / SETTING The study was conducted at 13 sites . A noninferiority design with a 1:1 r and omization was used . PATIENT SAMPLE Two hundred nine patients were r and omized and treated ( 106 ACDF ; 103 ProDisc-C ) . OUTCOME MEASURES Visual analog scale ( VAS ) pain and intensity ( neck and arm ) , VAS satisfaction , neck disability index ( NDI ) , neurological exam , device success , adverse event occurrence , and short form-36 ( SF-36 ) st and ardized question naires . METHODS A prospect i ve , r and omized , controlled clinical trial was performed . Patients were enrolled and treated in accordance with the US Food and Drug Administration ( FDA ) -approved protocol . Patients were assessed pre- and postoperatively at six weeks , 3 , 6 , 12 , 18 , and 24 months . RESULTS Demographics were similar between the two patient groups ( ProDisc-C : 42.1+/-8.4 years , 44.7 % males ; Fusion : 43.5 + /- 7.1 years , 46.2 % males ) . The most commonly treated level was C5-C6 ( ProDisc-C : 56.3 % ; Fusion=57.5 % ) . NDI and SF-36 scores were significantly less compared with presurgery scores at all follow-up visits for both the treatment groups ( p<.0001 ) . VAS neck pain intensity and frequency as well as VAS arm pain intensity and frequency were statistically lower at all follow-up timepoints compared with preoperative levels ( p<.0001 ) but were not different between treatments . Neurologic success ( improvement or maintenance ) was achieved at 24 months in 90.9 % of ProDisc-C and 88.0 % of Fusion patients ( p=.638 ) . Results show that at 24 months postoperatively , 84.4 % of ProDisc-C patients achieved a more than or equal to 4 degrees of motion or maintained motion relative to preoperative baseline at the operated level . There was a statistically significant difference in the number of secondary surgeries with 8.5 % of Fusion patients needing a re-operation , revision , or supplemental fixation within the 24 month postoperative period compared with 1.8 % of ProDisc-C patients ( p=.033 ) . At 24 months , there was a statistically significant difference in medication usage with 89.9 % of ProDisc-C patients not on strong narcotics or muscle relaxants , compared with 81.5 % of Fusion patients . CONCLUSIONS The results of this clinical trial demonstrate that ProDisc-C is a safe and effective surgical treatment for patients with disabling cervical radiculopathy because of single-level disease . By all primary and secondary measures evaluated , clinical outcomes after ProDisc-C implantation were either equivalent or superior to those same clinical outcomes after Fusion OBJECT The authors report the results of a prospect i ve r and omized multicenter study in which the results of cervical disc arthroplasty were compared with anterior cervical discectomy and fusion ( ACDF ) in patients treated for symptomatic single-level cervical degenerative disc disease ( DDD ) . METHODS Five hundred forty-one patients with single-level cervical DDD and radiculopathy were enrolled at 32 sites and r and omly assigned to one of two treatment groups : 276 patients in the investigational group underwent anterior cervical discectomy and decompression and arthroplasty with the PRESTIGE ST Cervical Disc System ( Medtronic Sofamor Danek ) ; 265 patients in the control group underwent decompressive ACDF . Eighty percent of the arthroplasty-treated patients ( 223 of 276 ) and 75 % of the control patients ( 198 of 265 ) completed clinical and radiographic follow-up examinations at routine intervals for 2 years after surgery . Analysis of all currently available postoperative 12- and 24-month data indicated a two-point greater improvement in the neck disability index score in the investigational group than the control group . The arthroplasty group also had a statistically significant higher rate of neurological success ( p = 0.005 ) as well as a lower rate of secondary revision surgeries ( p = 0.0277 ) and supplemental fixation ( p = 0.0031 ) . The mean improvement in the 36-Item Short Form Health Survey Physical Component Summary scores was greater in the investigational group at 12 and 24 months , as was relief of neck pain . The patients in the investigational group returned to work 16 days sooner than those in the control group , and the rate of adjacent-segment reoperation was significantly lower in the investigational group as well ( p = 0.0492 , log-rank test ) . The cervical disc implant maintained segmental sagittal angular motion averaging more than 7 degrees . In the investigational group , there were no cases of implant failure or migration . CONCLUSIONS The PRESTIGE ST Cervical Disc System maintained physiological segmental motion at 24 months after implantation and was associated with improved neurological success , improved clinical outcomes , and a reduced rate of secondary surgeries compared with ACDF Study Design Prospect i ve , r and omized , controlled . Level 1 evidence . Objective To report functional outcomes at 48 months follow-up on prospect ively r and omized patients to either the Bryan cervical disc prosthesis or anterior cervical discectomy and fusion ( ACDF ) at a single site . Summary of Background Data Surgical treatment of cervical disc pathology can involve discectomy and fusion ( ACDF ) , the gold st and ard technique . The safety and effectiveness of this procedure has been established and demonstrated in the literature , however , limitations have evolved and alternatives such as disc replacement are being investigated . Intervertebral disc replacement is design ed to preserve motion , both at affected and adjacent levels avoiding limitations of fusion such as adjacent level degeneration . New onset degenerative changes and possible recurring neurologic symptoms may be deferred or eliminated with cervical disc replacement . A recent multicenter trial with 24 months follow-up has shown the Bryan disc to compare favorably with ACDF . Continued follow-up is needed to further evaluate and compare functional outcomes in both these cohorts . Methods A total of 47 patients were enrolled at our site as part of an ongoing multicenter prospect ively r and omized study investigating ACDF versus Bryan cervical disc prosthesis . Functional outcomes are now reported at 48 months follow-up for our cohort of participants . Neck disability index score ( NDI ) , VAS neck and arm and SF-36 both physical and mental as well as complications and reoperations will be reported . Results Functional outcome data collected at routine follow-up for 48-months has favorably demonstrated improved functional outcomes for NDI , neck/arm pain VAS scores , and the SF-36 physical/mental health component scores for the Bryan arthroplasty and ACDF cohorts . The NDI scores for the Bryan arthroplasty preoperatively was 51 and at 48 months 10 . For ACDF preoperative NDI score was also 51 and at 48 months 16.7 . At 48 months NDI success , measured by ≥15 points NDI improvement demonstrated a 93.3 % success for Bryan arthroplasty and an 82.4 % success for ACDF . VAS neck pain scores for the Bryan arthroplasty preoperatively was 76.2 and at 48 months was 13.6 . VAS neck pain scores for ACDF preoperatively was 80.6 and at 48 months was 28.1 . Arm Pain scores were also measured and for the Bryan arthroplasty preoperatively measured 78.8 and at 48 months 10.8 . For ACDF arm pain scores preoperatively measured 77.1 and at 48 months 21.7 . These outcomes have not been associated with any degradation of outcome measures from 2 to 4 years . During the 48 months of follow-up at our institution we also report 6 secondary surgeries in our control group ( ACDF ) and only 1 in our investigational group ( Bryan ) . Of the 6 surgeries in the control group performed , 3 or 12 % to date were for adjacent level degenerative disease and 1 or 4 % for remote level degenerative disc disease . The remaining 2 surgeries were performed on the same patient for a pseudarthrosis . In the investigational group there was only 1 secondary surgery performed to date for adjacent level disease 5 % . Conclusions At 48 months , cervical arthroplasty with the Bryan cervical disc prosthesis continues to compare favorably to ACDF at our institution . There has been no degradation of functional outcomes from 24 to 48 months for NDI , VAS of neck and arm , and SF-36 . There has been a lower incidence of secondary surgeries for the Bryan arthroplasty cohort to date Study Design . Radiographic results of a multicenter , prospect i ve r and omized study comparing 1-level cervical total disc replacement ( TDR-C ) with anterior cervical discectomy and fusion ( ACDF ) . Objective . To evaluate the effect on device-level lordosis , cranial and caudal adjacent level lordosis , and overall cervical sagittal alignment ( C2–C6 ) after TDR-C or ACDF . Summary of Background Data . Cervical total disc replacement ( TDR-C ) has emerged as a promising alternative to ACDF in a select group of patients . The maintenance and /or improvement of sagittal balance is essential in preserving functionality after reconstructive spinal procedures . Recent studies have documented changes in spinal alignment after TDR-C , however , no studies have compared these changes to those noted in matched group of patients that have undergone ACDF . Methods . Radiographic data were obtained from the r and omized group of a multicenter , r and omized , prospect i ve , controlled study comparing TDR-C ( ProDisc-C , Synthes Spine , West Chester , PA ) with ACDF in the treatment of 1-level cervical disc disease . Complete radiographic data were available for 89 TDR-C patients ( average age : 42.2 years ) and 91 ACDF patients ( average age : 41.7 years ) . Cervical lordosis at the device level , cranial and caudal adjacent levels , and total cervical lordosis ( C2–C6 ) were independently measured before surgery and 2 years after surgery using custom image stabilization software ( Quantitative Motion Analysis , Medical Metrics , Inc , Houston , TX ) . Results . C5–C6 was the most common operative level ( TDR-C : 54 % ; ACDF : 55 % ) . At 2 years after surgery , the TDR-C group experienced statistically significant changes in lordosis of 3.0 ° ( P < 0.001 ) , 0.90 ° ( P = 0.006 ) , and −1.9 ° ( P < 0.001 ) at the operative , cranial , and caudal adj-acent levels , respectively . ACDF experienced changes in lordosis of 4.2 ° ( P < 0.001 ) , 1.0 ° ( P = 0.001 ) , and −1.5 ° ( P = 0.001 ) , respectively . The between-group differences were significant at the operative level ( P = 0.03 ) and the caudal adjacent level ( P = 0.05 ) . Total cervical lordosis increased in both TDR-C and ACDF by 3.1 ° and 3.8 ° , respectively ( P = 0.49 ) . Conclusion . In both TDR-C and ACDF , lordosis increased at the device-level , cranial adjacent level , and in total cervical lordosis , while lordosis decreased at the caudal adjacent level . Although ACDF facilitated a greater increase in device level lordosis ( + 1.25 ° ) and less loss of lordosis at the caudal adjacent level compared with TDR-C ( −0.39 ° ) , the clinical relevance of the small differences remain unknown Study Design . R and omized controlled study . Objective . To compare the rates of adverse events associated with disc arthroplasty versus those of anterior cervical discectomy and arthrodesis with allograft and plate . Summary of Background Data . Cervical disc arthroplasty as a substitute for fusion has been developed to maintain motion and , theoretically , prevent adjacent segment degeneration . Currently , cervical arthroplasty devices are undergoing clinical testing for safety and efficacy . The evaluation of safety is performed by critical analysis of all adverse occurrences following surgery to determine if the new device has a beneficial risk profile for the patient . Methods . Adverse events associated with Bryan Disc arthroplasty and arthrodesis were compared in a prospect i ve r and omized study . Four hundred sixty-three ( 463 ) patients having cervical radiculopathy and or myelopathy at a single level were treated at 31 sites . A total of 242 patients received the disc and 221 patients had anterior cervical discectomy and fusion . All patients were evaluated before surgery and at 1.5 , 3 , 6 , 12 , and 24 months after surgery . Adverse events were recorded concurrently and categorized by severity and as medically or surgically related . Results . No differences in overall medical events occurred between groups . Surgically related events occurred more frequently in the investigational group secondary
Output:
| There was no significant difference between the two groups in operation time , blood loss during operation , long-term all-complication rate and reoperation rate at the level of injury .
The ACDA group had significantly better neurological outcomes , as well as a significantly lower rate of adjacent segment diseases .
CONCLUSIONS Compared with ACDF , the ACDA procedure is associated with improved reoperation rate and reduction in neurological deficits amongst previously demonstrated benefits . |
MS213273 | ***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 examined the effects of megestrol acetate versus placebo and progressive resistance physical exercise on weight , lean muscle mass , quality of life , ability to exercise , proinflammatory cytokines , and anti-inflammatory cytokines , and their correlations with one another . DESIGN We organized a prospect i ve 20-week , r and omized , double-blind , placebo-controlled pilot trial of hemodialysis patients . SETTING This study took place at the Outpatient Unit of the Northport Veteran Affairs Medical Center . SUBJECTS We studied nine male hemodialysis patients who had two or more of the following : albumin level < 4.0 g/dL , total cholesterol < 150 mg/dL , protein catabolic rate < 0.8 g/kg/day , and predialysis serum urea nitrogen < 60 mg/dL. Their ages were 50 to 83 years . Two were diabetic , and seven were nondiabetic . INTERVENTIONS Interventions included megestrol acetate ( MA ) or placebo 800 mg oral daily for 20 weeks , along with weight resistance physical therapy with weights twice a week before dialysis . Patients were followed prospect ively for an additional 4 weeks . MAIN OUTCOME MEASUREMENTS Weight , body composition , activities of daily living , ability to exercise , and plasma cytokine levels were measured . RESULTS At 24 weeks , the MA group had a statistically significant weight gain ( 11.1-pound increase vs. 1.5-pound decrease for the placebo group , P = .018 ) , body fat gain ( 6.2-pound increase vs. a 0.4-pound decrease for the placebo group , P = .044 ) and fat-free mass gain ( 5-pound increase vs. a 1.2-pound decrease in the placebo group ) . The MA group also had a greater tendency toward increased appetite and sense of well-being . The MA group showed a greater improvement in ability to exercise ( mean change in rate of perceived exertion ( RPE ) , 4.7 ) vs. the placebo group ( mean change in RPE vs. 0.5 , P = .02 ) . Elevated cytokine levels were evident at baseline in both groups . In all patients , increases in weight , fat-free mass , sense of well-being , appetite , and ability to exercise were negatively correlated with tumor necrosis factor receptor subunit p75 ( P < .05 ) . There was a trend toward all of these parameters to be negatively correlated with tumor necrosis factor receptor subunit p55 , although only sense of well-being was statistically significant ( P < .05 ) . CONCLUSION In a pilot trial in dialysis patients , MA showed significant benefits in improving weight and ability to exercise . Cytokine changes were correlated with weight gains and increases in fat-free mass BACKGROUND Malnutrition-inflammation complex syndrome and anorexia , common conditions in maintenance dialysis patients , are strongly associated with higher mortality and hospitalization and lower quality of life ( QoL ) in this population . Megestrol acetate , 800 mg/day , has been shown to increase appetite and food intake and to mitigate inflammation in cachectic AIDS and cancer patients , leading to weight gain , but it is also associated with side effects at this dose . METHODS We evaluated the efficacy of the oral solution of megestrol acetate in half of its conventional dose in improving the nutritional state and inflammation in 10 hypoalbuminemic dialysis patients ( albumin < 3.7 g/dL ) . Six women and 4 men , ages 60.2 years , took 400 mg of megestrol acetate solution daily for 16 weeks . Anthropometry , dual energy x-ray absorptiometry , 24-hour diet recalls , and biochemical measurements of nutrition and inflammation , including serum C-reactive protein and leptin , were performed . RESULTS At the end of the 16 weeks of intervention , weight and body mass index increased by 9 % , body fat proportion by 31 % , and triceps skinfold by 40 % ( P < .01 ) . Serum albumin increased from 3.0 to 3.3 g/dL and continued to increase significantly to 3.6 g/dL after 3 months postintervention ( P = .03 ) . Serum leptin increased from 5.2 to 10.7 ng/mL ( P = .09 ) . Daily protein and energy intake increased progressively up to 27 % to 42 % by the end of the trial ( P < or = .01 ) . In 8 patients without acute infection , serum C-reactive protein declined from 1.24 to 0.78 mg/L ( P = .06 ) . QoL and appetite were reported to be improved . No major side effects were observed , and all 10 patients completed the 16 weeks of daily intake of megestrol acetate without interruption . CONCLUSIONS Megestrol acetate oral solution in half of its conventional dose is safe and improves the nutritional state , inflammation , and anorexia in maintenance dialysis patients . Larger-scale placebo-controlled r and omized studies are needed to confirm the beneficial effects of 400 mg/day of megestrol acetate in dialysis patients Weight loss is known to impact survival among patients infected with human immunodeficiency virus ( HIV ) even in the era of highly active antiretroviral therapy ( HAART ) . In a r and omized trial , we compared the effects of 2 months of treatment with either megestrol acetate ( 800 mg every day ) or ox and rolone ( 10 mg twice per day ) on body weight and composition in patients with weight loss of > or = 5 kg who were receiving HAART . The mean weight was 66 kg , and the mean body mass index was 21 . Mean weight gain in the megestrol acetate and the ox and rolone arms were 2.8 kg ( 4.6 % of the baseline value ) and 2.5 kg ( 3.9 % of the baseline value ) , respectively ( P=.80 ) . Lean body mass accounted for 39 % of weight gain in the megestrol acetate arm and 56 % in the ox and rolone arm ( P=.38 ) . Seven patients in the megestrol acetate arm and 5 patients in the ox and rolone arm reported minor adverse events ( P=.74 ) . In conclusion , megestrol acetate therapy and ox and rolone therapy have similar effects on body weight and composition and are safe and well-tolerated during HAART Aim : N-3 fatty acids , especially eicosapentaenoic acid ( EPA ) , may possess anticachectic properties . This trial compared a protein and energy dense supplement enriched with n-3 fatty acids and antioxidants ( experimental : E ) with an isocaloric isonitrogenous control supplement ( C ) for their effects on weight , lean body mass ( LBM ) , dietary intake , and quality of life in cachectic patients with advanced pancreatic cancer . Methods : A total of 200 patients ( 95 E ; 105 C ) were r and omised to consume two cans/day of the E or C supplement ( 480 ml , 620 kcal , 32 g protein ± 2.2 g EPA ) for eight weeks in a multicentre , r and omised , double blind trial . Results : At enrolment , patients ’ mean rate of weight loss was 3.3 kg/month . Intake of the supplements ( E or C ) was below the recommended dose ( 2 cans/day ) and averaged 1.4 cans/day . Over eight weeks , patients in both groups stopped losing weight ( Δ weight E : −0.25 kg/month versus C : −0.37 kg/month ; p = 0.74 ) and LBM ( Δ LBM E : + 0.27 kg/month versus C : + 0.12 kg/month ; p = 0.88 ) to an equal degree ( change from baseline E and C , p<0.001 ) . In view of evident non-compliance in both E and C groups , correlation analyses were undertaken to examine for potential dose-response relationships . E patients demonstrated significant correlations between their supplement intake and weight gain ( r = 0.50 , p<0.001 ) and increase in LBM ( r = 0.33 , p = 0.036 ) . Such correlations were not statistically significant in C patients . The relationship of supplement intake with change in LBM was significantly different between E and C patients ( p = 0.043 ) . Increased plasma EPA levels in the E group were associated with weight and LBM gain ( r = 0.50 , p<0.001 ; r = 0.51 , p = 0.001 ) . Weight gain was associated with improved quality of life ( p<0.01 ) only in the E group . Conclusion : Intention to treat group comparisons indicated that at the mean dose taken , enrichment with n-3 fatty acids did not provide a therapeutic advantage and that both supplements were equally effective in arresting weight loss . Post hoc dose-response analysis suggests that if taken in sufficient quantity , only the n-3 fatty acid enriched energy and protein dense supplement results in net gain of weight , lean tissue , and improved quality of life . Further trials are required to examine the potential role of n-3 enriched supplements in the treatment of cancer cachexia CONTEXT Reduced energy intake is a primary factor in HIV-associated wasting . Megestrol acetate ( MA ) stimulates appetite and weight gain . However , much of the weight gained is fat , possibly as a result of MA-induced hypogonadism . OBJECTIVE The objective of the study was to determine whether coadministration of testosterone with MA could enhance lean body mass ( LBM ) accrual and evaluate the effects of MA , alone or combined with testosterone , on sexual functioning and the hypothalamic-pituitary-adrenal axis . DESIGN This was a r and omized , double-blind , placebo-controlled , multicenter trial . SETTING Fourteen AIDS Clinical Trials Units in the United States participated in the study . SUBJECTS Seventy-nine HIV-positive men with 5 % or more weight loss or body mass index less than 20 kg/m2 took part in the study . INTERVENTION Subjects were r and omized to receive MA ( 800 mg daily ) plus testosterone enanthate ( 200 mg ; MA/TE ; n = 41 ) or placebo ( MA/PL ; n = 38 ) biweekly for 12 wk . MAIN OUTCOME MEASURES Weight , body composition ( bioelectric impedance analysis ) , adrenal and gonadal hormones , and sexual functioning ( question naire ) were measured . RESULTS Both groups experienced robust increases in weight ( median 5.3 and 7.3 kg in MA/TE and MA/PL , respectively ) , LBM ( 3.3 and 3.3 kg ) , and fat ( 3.0 and 3.8 kg ) . There were no significant differences between groups in the magnitude or composition of weight gain ( P = 0.44 , 0.90 , and 0.11 for weight , LBM , and fat , respectively ) . Trough testosterone concentrations decreased to a greater extent in MA/PL ( -12.3 vs. -6.1 nmol/liter in MA/TE ; P = 0.04 ) . Cortisol levels became nearly undetectable in subjects with plasma MA levels greater than 150 ng/ml . Sexual functioning was preserved with MA/TE but worsened in MA/PL . CONCLUSIONS MA produced robust weight gain . Coadministration of testosterone preserved sexual functioning but did not enhance LBM accrual BACKGROUND We examined changes in total body weight ( TBW ) and health-related quality of life ( HRQL ) during prolonged combination weight-gaining therapy and dietary advice in HIV . DESIGN This was a cohort study of patients initially r and omized to single agent therapy for 2 months , megestrol acetate ( 800 mg daily ) , or ox and rolone ( 10 mg twice daily ) , followed by both agents and dietary advice for 5 months . METHODS Two community health clinics and 1 urban infectious disease clinic were included , as were HIV-positive adult patients receiving highly active antiretroviral therapy with documented 5 % weight loss . TBW and HRQL were measured after 7 months ( 7 m ) . RESULTS Twenty-nine of 39 participants completed 7 m. The average sample age was 40 years , 75 % were male , and 52 % were of color at enrollment . Baseline mean TBW and body mass index ( BMI ) were 62.5 kg and 21 kg/m(2 ) , respectively . Net gains in TBW , lean body mass , and fat during the 7 m were 5.3 kg ( 8.5 % of baseline ) , 2.1 kg , and 3.1 kg , respectively ( p < .01 for each ) . BMI increased to 23.1 kg/m(2 ) ( p < .01 ) . Dietary intake increased by 467 kcal/day ( p = .03 ) . Physical health improved by 5.7 ( 100-point scale , p < .01 ) , and mental health was unchanged ( -4.2 , p = .11 ) . In multivariable models , female gender ( p < .01 ) , lower baseline HIV viral load ( p = .03 ) , and increasing age ( p < .01 ) were associated with TBW gain . Injection drug use ( p < .01 ) and higher baseline HIV viral load ( p < .01 ) were associated with reduction in physical health . CONCLUSIONS Prolonged combination ther
Output:
| There was little evidence to show significant impact on LBM , and no trials looked at muscle strength .
Current evidence does not support the use of progesterone therapies for non-cancer cachexia .
There may however be a limited role for its use as an appetite stimulant in a palliative context on a case-by-case basis |
MS213274 | ***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 mindfulness meditation interventions have recently shown benefits for reducing stress in various population s , little is known about their relative efficacy compared with relaxation interventions . Purpose : This r and omized controlled trial examines the effects of a 1-month mindfulness meditation versus somatic relaxation training as compared to a control group in 83 students ( M age=25 ; 16 men and 67 women ) reporting distress . Method : Psychological distress , positive states of mind , distractive and ruminative thoughts and behaviors , and spiritual experience were measured , while controlling for social desirability . Results : Hierarchical linear modeling reveals that both meditation and relaxation groups experienced significant decreases in distress as well as increases in positive mood states over time , compared with the control group ( p<.05 in all cases ) . There were no significant differences between meditation and relaxation on distress and positive mood states over time . Effect sizes for distress were large for both meditation and relaxation ( Cohen ’s d=1.36 and .91 , respectively ) , whereas the meditation group showed a larger effect size for positive states of mind than relaxation ( Cohen ’s d=.71 and .25 , respectively ) . The meditation group also demonstrated significant pre-post decreases in both distractive and ruminative thoughts/behaviors compared with the control group ( p<.04 in all cases ; Cohen ’s d=.57 for rumination and .25 for distraction for the meditation group ) , with mediation models suggesting that mindfulness meditation ’s effects on reducing distress were partially mediated by reducing rumination . No significant effects were found for spiritual experience . Conclusions : The data suggest that compared with a no-treatment control , brief training in mindfulness meditation or somatic relaxation reduces distress and improves positive mood states . However , mindfulness meditation may be specific in its ability to reduce distractive and ruminative thoughts and behaviors , and this ability may provide a unique mechanism by which mindfulness meditation reduces distress Depressive rumination - a central characteristic of Major Depressive Disorder ( MDD ) - is a maladaptive emotion regulation strategy that prolongs sad mood and depressive episodes . Considerable research demonstrates the emotional and behavioral consequences of depressive rumination , yet few studies investigate its effect on neuroendocrine functioning . The current study examined the effect of an emotion regulation manipulation on the trajectory of cortisol concentrations among individuals with MDD and healthy controls ( CTL ) . Sadness was induced via forced failure . Participants then were r and omly assigned to a depressive rumination or distraction emotion regulation induction . MDDs in the rumination condition exhibited less cortisol decline compared to MDDs in the distraction condition and compared to CTLs in either condition . Findings suggest that depressive rumination alters the trajectory of cortisol secretion in MDD and may prolong cortisol production . Results thereby provide important insights into the interaction of biological and psychological factors through which distress contributes to MDD This study examined an experiential avoidance conceptualization of depressive rumination in 3 ways : 1 ) associations among question naire measures of rumination , experiential avoidance , and fear of emotions ; 2 ) performance on a dichotic listening task that highlights preferences for non-depressive material ; and 3 ) psychophysiological reactivity in an avoidance paradigm modeled after the one used by Borkovec , Lyonfields , Wiser , and Deihl ( 1993 ) in their examination of worry . One hundred and thirty-eight undergraduates completed question naire measures and participated in a clinical interview to diagnose current and past episodes of depression . Of those , 100 were r and omly assigned to a rumination or relaxation induction condition and participated in a dichotic listening task , rumination/relaxation induction , and depression induction . Question naire measures confirmed a relationship between rumination status and avoidance ; however , no significant effects were found in the dichotic listening task . Psychophysiological measures indicated no difference in physiological response to a depression induction among high ruminators ( HR ) . However , low ruminators ( LR ) in the relaxation condition exhibited a larger IBI response than LR in the rumination condition . Overall , these results provide partial support for an avoidance conceptualization of depressive rumination . Implication s of these findings are discussed CONTEXT The terrorist attacks of 9/11 ( September 11 , 2001 ) present an unusual opportunity to examine prospect ively the physical health impact of extreme stress in a national sample . OBJECTIVE To examine the degree to which acute stress reactions to the 9/11 terrorist attacks predict cardiovascular outcomes in a national probability sample over the subsequent 3 years . DESIGN , SETTING , AND PARTICIPANTS A national probability sample of 2729 adults ( 78.1 % participation rate ) , 95.0 % of whom had completed a health survey before 9/11 ( final health sample , 2592 ) , completed a Web-based assessment of acute stress responses approximately 9 to 14 days after the terrorist attacks . Follow-up health surveys reassessed physician-diagnosed cardiovascular ailments 1 ( n = 1923 , 84.3 % participation rate ) , 2 ( n = 1576 , 74.2 % participation rate ) , and 3 ( n = 1950 , 78.9 % participation rate ) years following the attacks . MAIN OUTCOME MEASURES Reports of physician-diagnosed cardiovascular ailments over the 3 years following the attacks . RESULTS Acute stress responses to the 9/11 attacks were associated with a 53 % increased incidence of cardiovascular ailments over the 3 subsequent years , even after adjusting for pre-9/11 cardiovascular and mental health status , degree of exposure to the attacks , cardiovascular risk factors ( ie , smoking , body mass index , and number of endocrine ailments ) , total number of physical health ailments , somatization , and demographics . Individuals reporting high levels of acute stress immediately following the attacks reported an increased incidence of physician-diagnosed hypertension ( rate ratios , 2.15 at 1 year and 1.75 at 2 years ) and heart problems ( rate ratios , 2.98 at 1 year and 3.12 at 2 years ) over 2 years . Among individuals reporting ongoing worry about terrorism post-9/11 , high 9/11-related acute stress symptoms predicted increased risk of physician-diagnosed heart problems 2 to 3 years following the attacks ( rate ratios , 4.67 at 2 years and 3.22 at 3 years ) . CONCLUSION Using health data collected before 9/11 as a baseline , acute stress response to the terrorist attacks predicted increased reports of physician-diagnosed cardiovascular ailments over 3 years following the attacks BACKGROUND Worry is an important component of anxiety , which recent work suggests is related to increased incidence of coronary heart disease ( CHD ) . Chronic worry has also been associated with decreased heart rate variability . We hypothesized that high levels of worry may increase CHD risk . METHOD AND RESULTS We examined prospect ively the relationship of worry with CHD incidence in the Normative Aging Study , an ongoing cohort of older men . In 1975 , 1759 men free of diagnosed CHD completed a Worries Scale , indicating the extent to which they worried about each of five worry domains : social conditions , health , financial , self-definition , and aging . During 20 years of follow-up , 323 cases of incident CHD occurred : 113 cases of nonfatal myocardial infa rct ion ( MI ) ; 86 cases of fatal CHD ; and 124 cases of angina pectoris . Worry about social conditions was the domain most strongly associated with incident CHD . Compared with men reporting the lowest levels of social conditions worry , men reporting the highest levels had multivariate adjusted relative risks of 2.41 ( 95 % CI , 1.40 to 4.13 ) for nonfatal MI and 1.48 ( 95 % CI , 0.99 to 2.20 ) for total CHD ( nonfatal MI and fatal CHD ) . A dose-response relation was found between level of worry and both nonfatal MI ( P for trend , .002 ) and total CHD ( P for trend , .04 ) . CONCLUSIONS These results suggest that high levels of worry in specific domains may increase the risk of CHD in older men Objective : Cardiovascular recovery of prestress baseline blood pressure has been implicated as a possible additional determinant of sustained blood pressure elevation . We hypothesize that angry ruminations may slow the recovery process . Method : A within-subjects design was used in which resting baseline blood pressure and heart rate measurements were assessed on 60 subjects , who then took part in two anger-recall tasks . After each task , subjects sat quietly and alone during a 12-minute recovery period r and omized to with or without distractions . During baseline , task , and recovery , blood pressure was continuously monitored ; during recovery , subjects reported their thoughts at five fixed intervals . Results : Fewer angry thoughts were reported in the distraction condition ( 17 % ) compared with no distraction ( 31 % ; p = .002 ) ; an interaction showed that this effect was largely the result of the two intervals immediately after the anger-recall task . Trait rumination interacted with distraction condition such that high ruminators in the no-distraction condition evidence d the poorest blood pressure recovery , assessed as area under the curve ( p = .044 [ systolic blood pressure ] and p = .046 [ diastolic pressure ] ) . Conclusions : People who have a tendency to ruminate about past anger-provoking events may be at greater risk for target organ damage as a result of sustained blood pressure elevations ; the effect is exacerbated when distractions are not available to interrupt the ruminative process . ANOVA = analysis of variance ; AUC = area under the curve ; BP = blood pressure ; HTN = hypertension ; CHD = coronary heart disease ; CVR = cardiovascular reactivity ; CVD = cardiovascular disease ; HR = heart rate ; DAB-VR = Destructive Anger Behavior-Verbal Rumination ; DBP = diastolic BP ; HPA = hypothalamic-pituitary-adrenal ; SBP = systolic BP In this study we examined the prospect i ve relationships between perseverative thoughts , internalizing negative emotions , and somatic complaints in children aged 9 - 13 , and evaluated whether a perseverative thoughts intervention had a beneficial effect on these experiences . Children ( N=227 ) from 7 primary schools in Leiden , the Netherl and s , recorded their perseverative thoughts during one week , 138 of whom were instructed to postpone these thoughts to a special 30min period in the early evening . Children who had received the postponement instructions showed a reduction in the frequency of perseverative thoughts , and girls also in the duration of them . Girl 's perseverative thoughts were positively associated with the number of somatic complaints and with negative emotions . The postponement intervention also seemed to reduce somatic complaints in the seventh grade children . These findings confirm the previously found prospect i ve relationship between perseverative thoughts and children 's well-being and provide initial validation for the use of the postponement intervention to reduce perseverative thoughts in this age group , particularly for girls Recent models of generalized anxiety disorder ( GAD ) have exp and ed on Borkovec 's avoidance theory by delineating emotion regulation deficits associated with the excessive worry characteristic of this disorder ( see Behar , DiMarco , Hekler , Mohlman , & Staples , 2009 ) . However , it has been difficult to determine whether emotion regulation is simply a useful heuristic for the avoidant properties of worry or an important extension to conceptualizations of GAD . Some of this difficulty may arise from a focus on purported maladaptive regulation strategies , which may be confounded with symptomatic distress components of the disorder ( such as worry ) . We examined the implementation of adaptive regulation strategies by participants with and without a diagnosis of GAD while watching emotion-eliciting film clips . In a between-subjects design , participants were r and omly assigned to accept , reappraise , or were not given specific regulation instructions . Implementation of adaptive regulation strategies produced differential effects in the physiological ( but not subjective ) domain across diagnostic groups . Whereas participants with GAD demonstrated lower cardiac flexibility when implementing adaptive regulation strategies than when not given specific instructions on how to regulate , healthy controls showed the opposite pattern , suggesting they benefited from the use of adaptive regulation strategies . We discuss the implication s of these findings for the delineation of emotion regulation deficits in psychopathology Comorbidity among affective disorders is high . Rumination has been found to mediate cross-sectional and prospect i ve relations between anxiety and depressive symptoms in adolescents and adults . We examined whether rumination and worry , both forms of repetitive negative thinking , also explain the associations between affective disorders . This was studied using a prospect i ve cohort study . In a mixed sample of 2981 adults ( persons with a prior history of or a current affective disorder and healthy individuals ) we assessed DSM-IV affective disorders ( CIDI ) , rumination ( LEIDS-R ) and worry ( PSWQ ) . All measures were repeated 2 years and 4 years later . Using structural equation models , we found that baseline rumination and worry partly mediated the association of baseline fear disorders ( social anxiety disorder , panic disorder , agoraphobia ) with distress disorders ( dysthymia , major depressive disorder , generalized anxiety disorder ) . Moreover , baseline fear disorders predicted changes in distress disorders and changes in worry and rumination mediated these associations . The association between baseline distress disorders and changes in fear disorders was mediated by changes in rumination but not by changes in worry . From these results it can be concluded that repetitive negative thinking is an important transdiagnostic factor . Rumination and worry are partly responsible for the cross-sectional and prospect i ve co-occurrence of affective disorders
Output:
| Results show that perseverative cognition affects cardiovascular , autonomic , and endocrine nervous system activity , suggesting a pathogenic pathway to long-term disease outcomes and clarifying the still unexplained relationship between chronic stress and health vulnerability |
MS213275 | ***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 Aims An immune imbalance in the cytokine profile exerts a profound influence on the progression of hepatitis B virus ( HBV ) infections and hepatocellular carcinoma ( HCC ) . The present study evaluated the immune status of T helper ( Th ) 17 and Th1 cells in patients with HBV-related and non-HBV-related HCC . Methods We r and omly enrolled 150 patients with HCC . Blood sample s and tissue sample s were obtained . The distributions and phenotypic features of Th17 and Th1 cells were determined by flow cytometry and /or immunohistochemistry . Results Compared to corresponding non-tumor regions , the levels of Th17 and Th1 cells were significantly increased in tumors of patients with HCC ( P<0.001 ) . The intratumoral densities of IL-17-producing cells and IFN-γ-producing cells were associated with overall survival ( OS , P = 0.001 ) and disease-free survival ( DFS , P = 0.001 ) of patients with HCC . The ratio of Th17 to Th1 in HBV-related HCC was higher than in non-HBV-related HCC . A multivariate Cox analysis revealed that the Th17 to Th1 ratio was an independent prognostic factor for OS ( HR = 2.651 , P = 0.007 ) and DFS ( HR = 2.456 , P = 0.002 ) . Conclusions HBV infections can lead to an imbalance in immune status in patients with HCC . An elevated Th17 to Th1 ratio may promote tumor progression . The Th17 to Th1 ratio could serve as a potential prognostic marker for scoring the severity of HCC Purpose The role of interleukin-17 ( IL-17 ) in the tumor microenvironment is controversial . We analyzed the in situ tumor expression of IL-17 in colorectal cancer ( CRC ) , adenoma and non-tumor tissue to explore the possible correlation of IL-17 expression to clinicopathological characteristics , tumor-infiltrating neutrophils ( TINs ) and survival in CRC . Methods We review ed the records of 78 consecutive patients diagnosed with CRC . Archival tissues were used . Thirty-six patients with colorectal adenoma were also included . From the 78 CRC patients , we r and omly chose 40 cases and collected non-tumor tissue at 10 cm from the edge of the resected tumor . Immunohistochemistry was performed using anti-IL-17 and anti-CD15 ( targeting neutrophils ) antibody , respectively . Real-time PCR was used to detect IL-17 mRNA in different tissues . Associations between IL-17 expression , clinicopathological parameters and prognosis were evaluated . Results The level of IL-17 mRNA was higher in CRC than in adenoma and non-tumor tissue ( P < 0.05 ) . Positive IL-17 protein expression was observed more frequently in CRC as compared to colorectal adenoma and non-tumor tissue , respectively ( P < 0.01 ) . IL-17 expression correlated to well differentiation and early stage CRC . The number of CD15 + neutrophils significantly increased in CRC and positively correlated to the expression of IL-17 ( P < 0.05 ) . Both Kaplan – Meier analysis and multivariate Cox regression analysis indicated that patients with positive IL-17 expression showed better overall survival . Conclusions The association between IL-17 expression and the clinicopathological parameters , as well as the clinical outcome suggests a significant role of IL-17 in CRC . IL-17 is a marker of favorable prognosis Purpose : To determine safety and feasibility of adjuvant ipilimumab following resection of high-risk melanoma and to identify surrogate markers for benefit . Experimental Design : In this phase II trial , 75 patients with resected stage IIIc/IV melanoma received the CTLA-4 antibody ipilimumab every 6 to 8 weeks for 1 year . Eligible patients received further maintenance treatments . The first 25 patients received 3 mg/kg of ipilimumab , and an additional 50 patients received 10 mg/kg . HLA-A*0201 + patients received multipeptide immunizations in combination with ipilimumab . Leukapheresis was performed prior to and 6 months after initiation of treatment . Results : Median overall and relapse-free survivals were not reached after a median follow-up of 29.5 months . Significant immune-related adverse events were observed in 28 of 75 patients and were positively associated with longer relapse-free survival . Antigen-specific T cell responses to vaccine were variable , and vaccine combination was not associated with additional benefit . No effects on T regulatory cells were observed . Higher changes in Th-17 inducible frequency were a surrogate marker of freedom from relapse ( P = 0.047 ) , and higher baseline C-reactive protein ( CRP ) levels were associated with freedom from relapse ( P = 0.035 ) . Conclusions : Adjuvant ipilimumab following resection of melanoma at high risk for relapse appeared to be associated with improved outcome compared to historical reports . Significant immune-related adverse events were generally reversible and appeared to be associated with improved relapse-free survival . Although vaccination failed to induce a consistent in vitro measurable response , a higher change in Th-17 inducible cells and higher baseline CRP levels were positively associated with freedom from relapse . Clin Cancer Res ; 17(4 ) ; 896–906 . © 2010 AACR Transarterial chemoembolization ( TACE ) has therapeutic effects in patients with unresectable hepatocellular carcinoma ( HCC ) , but its impact on the cellular immune response during disease progression is largely unknown . Here we conducted a prospect i ve study to evaluate the effect of TACE on immune status and to identify prognostic immune markers governing treatment success . In this study , 51 stage III HCC patients , 28 stage I HCC patients ( TNM classification ) and 20 healthy donors were enrolled . Flow cytometry and cytometric bead array were used to evaluate the circulating immune cell subsets , including CD4 + T cells ( Th1 , Th17 and Treg cells ) , CD8 + T cells , NK cells , and NKT cells , and plasma cytokines before TACE and 30 days after TACE . Interestingly , among those immune parameters , the frequency of circulating Th17 cells was higher in stage III HCC patients than in stage I HCC patients ( P = 0.015 ) and healthy donors ( P<0.001 ) . Moreover , an increased frequency of circulating Th17 cells was observed 30 days after TACE ( Th17D30 ) compared with the baseline level ( P = 0.036 ) . Kaplan-Meier analysis demonstrated that Th17D30 was positively associated with overall survival ( OS ; P = 0.007 ) and time to progression ( TTP ; P = 0.009 ) . Multivariate Cox analysis revealed that Th17D30 was an independent prognostic factor for OS ( HR = 0.317 , P = 0.032 ) and TTP ( HR = 0.304 , P = 0.010 ) . These results provide a potential prognostic marker for stage III HCC patients undergoing TACE and may be useful for identifying patients who can benefit from adjuvant immunotherapies Host immunity may have important role in the prognosis of hepatocellular carcinoma ( HCC ) . The aim of this study was to evaluate the correlation between circulating immune regulators and clinical outcome in patients with HCC . Sixty-three HCC patients were prospect ively enrolled . Serum levels of interleukin-10 ( IL-10 ) , transforming growth factor-beta ( TGF-β ) , interferon-gamma ( IFN-γ ) and interferon gamma-inducible protein 10 ( IP-10 ) were measured , as well as the prevalence of regulatory T cells ( Treg ) , NK(+ ) T cells , invariant natural killer T cells ( iNKT ) , programmed cell death-1 (PD-1)(+ ) CD8(+ ) T cells , T helper 17 cells ( Th17 ) , CD69(+ ) and CD45RO(+ ) T cells in peripheral blood mononuclear cells ( P BMC ) . Correlation between these immune regulators and clinical outcome were analyzed . A low serum IFN-γ level ( < 50 pg/mL ) was significantly associated tumor stage ( BCLC stage B : 61.25 % vs. stage A : 25 % , p = 0.010 ) and tumor size ( > 5 cm : 53.8 % vs. < 5 cm : 25 % , p = 0.047 ) . Recurrence-free survival was evaluated in 48 patients receiving curative treatment of HCC . By multivariate analysis , BCLC stage [ hazard ratio ( HR ) = 32.180 , p < 0.001 ] , tumor size ( HR = 15.373 , p = 0.005 ) , AST ( HR = 3.796 , p = 0.011 ) and IFN-γ ( HR = 0.354 , p = 0.018 ) levels were independent factors associated with recurrence-free survival . In conclusion , serum IFN-γ level correlates with tumor stage and tumor size in HCC patients . Patients with lower baseline IFN-γ levels have a higher risk of tumor recurrence after curative treatment . IFN-γ may reflect host anti-tumor immunity and may be a potential marker of HCC recurrence after curative treatment BACKGROUND / AIMS To characterize IL-17-producing cells , a newly defined T helper cell subset with potent pro-inflammatory properties , in hepatocellular carcinoma ( HCC ) and to determine their prognostic values . METHODS One hundred and seventy-eight HCC patients were enrolled r and omly . Distribution and phenotypic features of IL-17-producing cells were determined by flow cytometry and /or immunohistochemistry . RESULTS Compared with corresponding non-tumor regions , the levels of Th17 cells were significantly increased in tumors of HCC patients ( P<0.001 ) . Most intratumoral Th17 cells exhibited an effector memory phenotype with increased expression of CCR4 and CCR6 . Intratumoral IL-17-producing cell density was associated with overall survival ( OS , P=0.001 ) and disease-free survival ( DFS , P=0.001 ) in HCC patients . Multivariate Cox analysis revealed that intratumoral IL-17-producing cell density was an independent prognostic factor for OS ( HR=2.351 , P=0.009 ) and DFS ( HR=2.256 , P=0.002 ) . Moreover , the levels of intratumoral Th17 cells were positively correlated with microvessel density in tumors ( r=0.616 , P=0.001 ) . CONCLUSION Accumulation of intratumoral IL-17-producing cells may promote tumor progression through fostering angiogenesis , and intratumoral IL-17-producing cell could serve as a potential prognostic marker and a novel therapeutic target for HCC
Output:
| Since Th17 cells are a sub population of IL-17 + cells and had a different correlation with prognosis than total IL-17 , we substantiate that a distinction should be made between Th17 and other IL-17 + cells |
MS213276 | ***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 Osteoporosis may be prevented or delayed by maximizing peak bone mass through diet modification and physical activity during adolescence . OBJECTIVE We studied whether increases in calcium intake and physical activity effectively increase the bone mineral status of adolescent girls aged 16 - 18 y. DESIGN We conducted a 15.5-mo study of calcium supplementation ( 1000 mg Ca/d as carbonate ) in 144 adolescent girls aged 17.3 + /- 0.3 y ( + /- SD ) . The subjects were r and omly allocated to an exercise ( three 45-min exercise-to-music classes/wk during term time ) or nonexercise group . Dual-energy X-ray absorptiometry of the whole body , spine , forearm , and hip was performed before and after intervention . RESULTS The mean ( + /- SD ) percentage of subjects compliant with supplement taking was 70 + /- 27 % and with exercise class attendance was 36 + /- 25 % . Baseline calcium intake was 938 + /- 411 mg/d . Calcium supplementation significantly increased size-adjusted bone mineral content . The effect was stronger in subjects with good compliance ( percentage difference + /- SE ) : whole body , 0.8 + /- 0.3 % ( P < or = 0.01 ) ; lumbar spine , 1.9 + /- 0.5 % ( P < or = 0.001 ) ; ultradistal radius , 1.3 + /- 0.6 % ( P < or = 0.05 ) ; total hip , 2.7 + /- 0.6 % ( P < or = 0.001 ) ; femoral neck , 2.2 + /- 0.7 % ( P < or = 0.001 ) ; trochanter , 4.8 + /- 0.9 % ( P < or = 0.001 ) . Attendance at > 50 % of the exercise sessions was significant at the total hip ( 1.4 + /- 0.7 % ; P < or = 0.05 ) and trochanter ( 2.6 + /- 1.2 % ; P < or = 0.05 ) . CONCLUSIONS Calcium supplementation and exercise enhanced bone mineral status in adolescent girls . Whether this is a lasting benefit , leading to the optimization of peak bone mass and a reduction in fracture risk , needs to be determined Exercise during growth has a positive influence on bone mineral accrual , yet little is known about how bone geometry and strength adapt to loading during growth . Our primary objective was to compare changes in proximal femur bone geometry and strength between 31 prepubertal ( Tanner Stage 1 ) boys who participated in a school-based , high-impact circuit intervention ( 12 min , three times a week ) for 20 months and 33 maturity-matched controls . Our secondary objective was to compare changes in total body ( TB ) , proximal femur ( PF ) , and lumbar spine ( LS ) bone mineral content ( BMC ) and bone area ( BA ) in these groups . We assessed geometric variables and bone strength at the narrow neck ( NN ) , intertrochanteric ( TR ) region , and femoral shaft regions by applying the Hip Structure Analysis program to proximal femur dual energy X-ray absorptiometry scans ( DXA , Hologic QDR 4500 ) . Further , we assessed total body , lumbar spine , and proximal femur BMC and BA by DXA and derived total body lean mass and fat mass from total body scans . Intervention ( 10.2 + /- 0.5 years ) and control boys ( 10.1 + /- 0.5 years ) had similar baseline height ( 140.8 vs. 141.3 cm ) and weight ( 36.9 vs. 35.4 kg ) , and average 20-month physical activity scores ( Physical Activity Question naire for Children , PAQ-C ) and calcium intakes ( 861 vs. 852 mg/day , food frequency question naire ) . Twenty-month height and weight changes were not significantly different between groups ; lean mass changed more ( P < 0.05 ) in intervention boys ( 22.8 % ) than control boys ( 18.6 % ) . At the NN region , intervention boys had greater bone expansion on both the periosteal ( + 2.6 % , P = 0.1 ) and endosteal ( + 2.7 % , P = 0.2 ) surfaces , result ing in significantly greater changes in section modulus ( bone bending strength ) ( + 7.5 % , P = 0.02 , ANCOVA , adjusting for height change , final Tanner Stage , and baseline bone values ) . Changes at the intertrochanteric and femoral shaft regions were not significantly different between groups . Femoral neck ( FN ) BMC changes were significantly greater in intervention boys ( + 4.3 % , P < 0.01 ) ; changes in BA and BMC for other regions were not significantly different between groups . In summary , a school-based , high-impact exercise intervention implemented three times a week for 12 min is an effective strategy for site-specific gains in bone strength at the narrow neck region of the proximal femur Cross-sectional studies of elite athletes suggest that growth is an opportune time for exercise to increase areal bone mineral density ( BMD ) . However , as the exercise undertaken by athletes is beyond the reach of most individuals , these studies provide little basis for making recommendations regarding the role of exercise in musculoskeletal health in the community . To determine whether moderate exercise increases bone mass , size , areal , and volumetric BMD , two socioeconomically equivalent schools were r and omly allocated to be the source of an exercise group or controls . Twenty boys ( mean age 10.4 years , range 8.4 - 11.8 ) allocated to 8 months of 30-minute sessions of weight-bearing physical education lessons three times weekly were compared with 20 controls matched for age , st and ing and sitting height , weight , and baseline areal BMD . Areal BMD , measured using dual-energy X-ray absorptiometry , increased in both groups at all sites , except at the head and arms . The increase in areal BMD in the exercise group was twice that in controls ; lumbar spine ( 0.61 + /- 0.11 vs. 0.26 + /- 0.09%/month ) , legs ( 0.76 + /- 0.07 vs. 0.34 + /- 0.08%/month ) , and total body ( 0.32 + /- 0.04 vs. 0.17 + /- 0.06%/month ) ( all p < 0.05 ) . In the exercise group , femoral midshaft cortical thickness increased by 0.97 + /- 0 . 32%/month due to a 0.93 + /- 0.33%/month decrease in endocortical ( medullary ) diameter ( both p < 0.05 ) . There was no periosteal expansion so that volumetric BMD increased by 1.14 + /- 0.33%/month , ( p < 0.05 ) . Cortical thickness and volumetric BMD did not change in controls . Femoral midshaft section modulus increased by 2.34 + /- 2 . 35 cm3 in the exercise group , and 3.04 + /- 1.14 cm3 in controls ( p < 0.05 ) . The growing skeleton is sensitive to exercise . Moderate and readily accessible weight-bearing exercise undertaken before puberty may increase femoral volumetric BMD by increasing cortical thickness . Although endocortical apposition may be a less effective means of increasing bone strength than periosteal apposition , both mechanisms will result in higher cortical thickness that is likely to offset bone fragility conferred by menopause-related and age-related endocortical bone resorption Abstract : The maximum amount of bone a person can obtain during the first two decades of life is an important determinant of bone mass in later life , and an increase in peak bone mass has been associated with decreased risk for osteoporotic fractures . It is known that growth of bone and thus development of peak bone mass are strongly controlled by genetic factors , but information on the role of environmental factors , such as exercise and nutrition , ( e.g. , exercise ) on growing bone is limited . We tested a hypothesis that in growing girls the benefit of mechanical loading on bone mineral mass and bone strength is better before rather than after the menarche . Sixty-four girls ( 25 premenarcheal , 39 postmenarcheal ) carried out a supervised 9-month step-aerobic program ( two sessions per week ) , each session complemented with additional jumps . Sixty-two girls ( 33 premenarcheal , 29 postmenarcheal ) served as controls . Bone mineral content ( BMC ) at the lumbar spine and proximal femur was measured by dual-energy X-ray absorptiometry ( DXA ) . In addition , the cortical density ( CoD , mg/cm3 ) and cortical cross-sectional area ( CoA , mm2 ) and the density-weighted polar section modulus ( BSI , mm3 ) of the tibial midshaft were determined by peripheral quantitative tomography ( pQCT ) . In the premenarcheal girls , BMC increased statistically significantly more in the trainees than controls at the lumbar spine ( p= 0.012 ) ( 8.6 % vs 5.3 % ) and femoral neck ( p= 0.014 ) ( 9.3 % vs 5.3 % ) . In the tibial midshaft , the intergroup differences ( CoD , CoA and BSI ) were not significant . The postmenarcheal girls showed no significant post-training intergroup differences in any of the bone parameters ( BMC increased in the lumbar spine 6.0 % vs 4.9 % ; femoral neck 3.4 % vs 3.2 % ; and trochanter 2.6 % vs 3.5 % ) . Although a large proportion of bone mineral increase in the growing girls of this study was attributable to growth itself , this 9-month exercise intervention showed that a clear and large additional bone gain could be obtained in exercising premenarcheal girls , but not in exercising postmenarcheal girls . In other words , exercise seemed more beneficial for additional bone mineral acquisition before menarche ( i.e. , during the growth spurt ) rather than after it Physical activity during childhood is advocated as one strategy for enhancing peak bone mass ( bone mineral content [ BMC ] ) as a means to reduce osteoporosis-related fractures . Thus , we investigated the effects of high-intensity jumping on hip and lumbar spine bone mass in children . Eighty-nine prepubescent children between the ages of 5.9 and 9.8 years were r and omized into a jumping ( n = 25 boys and n = 20 girls ) or control group ( n = 26 boys and n = 18 girls ) . Both groups participated in the 7-month exercise intervention during the school day three times per week . The jumping group performed 100 , two-footed jumps off 61-cm boxes each session , while the control group performed nonimpact stretching exercises . BMC ( g ) , bone area ( BA ; cm2 ) , and bone mineral density ( BMD ; g/cm2 ) of the left proximal femoral neck and lumbar spine ( L1-L4 ) were assessed by dual-energy X-ray absorptiometry ( DXA ; Hologic QDR/4500-A ) . Peak ground reaction forces were calculated across 100 , two-footed jumps from a 61-cm box . In addition , anthropometric characteristics ( height , weight , and body fat ) , physical activity , and dietary calcium intake were assessed . At baseline there were no differences between groups for anthropometric characteristics , dietary calcium intake , or bone variables . After 7 months , jumpers and controls had similar increases in height , weight , and body fat . Using repeated measures analysis of covariance ( ANCOVA ; covariates , initial age and bone values , and changes in height and weight ) for BMC , the primary outcome variable , jumpers had significantly greater 7-month changes at the femoral neck and lumbar spine than controls ( 4.5 % and 3.1 % , respectively ) . In repeated measures ANCOVA of secondary outcomes ( BMD and BA ) , BMD at the lumbar spine was significantly greater in jumpers than in controls ( 2.0 % ) and approached statistical significance at the femoral neck ( 1.4 % ; p = 0.085 ) . For BA , jumpers had significantly greater increases at the femoral neck area than controls ( 2.9 % ) but were not different at the spine . Our data indicate that jumping at ground reaction forces of eight times body weight is a safe , effective , and simple method of improving bone mass at the hip and spine in children . This program could be easily incorporated into physical education classes OBJECTIVE To evaluate the effects of an elementary school-based physical education exercise intervention program on bone mineral accrual in prepubertal and early pubertal girls . STUDY DESIGN A total of 14 schools were r and omly assigned to control ( C ) and intervention ( I ) groups . Girls in the I group completed a 10-minute , 3 times per week circuit of varied jumping activities over 7 months . We measured total body , lumbar spine , proximal femur , femoral neck , and trochanteric bone mineral content and areal bone mineral density and estimated femoral neck volumetric bone mineral density at baseline and final measurement in 87 girls in the I group and 90 girls in the C group . Girls were between 8.7 and 11.7 years at baseline . Tanner stage 1 girls were considered prepubertal ; Tanner stages 2 and 3 girls were considered early pubertal . We
Output:
| Although weight-bearing exercise appears to enhance bone mineral accrual in children , particularly during early puberty ; it remains unclear as to what constitutes the optimal exercise programme .
In addition , the measurement of bone quality parameters and volumetric BMD would provide a greater insight into the mechanisms implicated in the adaptation of bone to exercise |
MS213277 | ***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 . Previous research has shown that children can increase their muscular strength and muscular endurance as a result of regular participation in a progressive resistance training program . However , the most effective exercise prescription regarding the number of repetitions remains question able . Objective . To compare the effects of a low repetition – heavy load resistance training program and a high repetition – moderate load resistance training program on the development of muscular strength and muscular endurance in children . Design . Prospect i ve , controlled trial . Setting . Community-based youth fitness center . Subjects . Eleven girls and 32 boys between the ages of 5.2 and 11.8 years . Intervention . In twice-weekly sessions of resistance training for 8 weeks , children performed 1 set of 6 to 8 repetitions with a heavy load ( n = 15 ) or 1 set of 13 to 15 repetitions with a moderate load ( n = 16 ) on child-size exercise machines . Children in the control group ( n = 12 ) did not resistance train . One repetition maximum ( RM ) strength and muscular endurance ( repetitions performed posttraining with the pretraining 1-RM load ) were determined on the leg extension and chest press exercises . Results . One RM leg extension strength significantly increased in both exercise groups compared with that in the control subjects . Increases of 31.0 % and 40.9 % , respectively , for the low repetition – heavy load and high repetition – moderate load groups were observed . Leg extension muscular endurance significantly increased in both exercise groups compared with that in the control subjects , although gains result ing from high repetition – moderate load training ( 13.1 ± 6.2 repetitions ) were significantly greater than those result ing from low repetition – heavy load training ( 8.7 ± 2.9 repetitions ) . On the chest press exercise , only the high repetition – moderate load exercise group made gains in 1-RM strength ( 16.3 % ) and muscular endurance ( 5.2 ± 3.6 repetitions ) that were significantly greater than gains in the control subjects . Conclusion . These findings support the concept that muscular strength and muscular endurance can be improved during the childhood years and favor the prescription of higher repetition – moderate load resistance training programs during the initial adaptation period The purpose of the present study was to examine the influence of direct supervision on muscular strength , power , and running speed during 12 weeks of resistance training in young rugby league players . Two matched groups of young ( 16.7 ± 1.1 years [ mean ± SD ] ) , talented rugby league players completed the same periodized resistance-training program in either a supervised ( SUP ) ( N = 21 ) or an unsupervised ( UNSUP ) ( N = 21 ) environment . Measures of 3 repetition maximum ( 3RM ) bench press , 3RM squat , maximal chin-ups , vertical jump , 10– and 20-m sprints , and body mass were completed pretest ( week 0 ) , midtest ( week 6 ) , and posttest ( week 12 ) training program . Results show that 12 weeks of periodized resistance training result ed in an increased body mass , 3RM bench press , 3RM squat , maximum number of chin-ups , vertical jump height , and 10– and 20-m sprint performance in both groups ( p < 0.05 ) . The SUP group completed significantly more training sessions , which were significantly correlated to strength increases for 3RM bench press and squat ( p < 0.05 ) . Furthermore , the SUP group significantly increased 3RM squat strength ( at 6 and 12 weeks ) and 3RM bench press strength ( 12 weeks ) when compared to the UNSUP group ( p < 0.05 ) . Finally , the percent increase in the 3RM bench press , 3RM squat , and chin-upmax was also significantly greater in the SUP group than in the UNSUP group ( p < 0.05 ) . These findings show that the direct supervision of resistance training in young athletes results in greater training adherence and increased strength gains than does unsupervised training BACKGROUND : In developed societies levels of daily physical activity ( PA ) among school-age children are decreasing . This implies risk factors for cardiovascular and metabolic diseases . Specific strategies to improve levels of PA are needed . In prepubertal boys there is evidence that strength training increases spontaneous PA outside of training . METHODS : A total of 102 schoolchildren ( age 10–14 years ) in Switzerl and were r and omly assigned to physical education classes or to participate twice weekly at a guided strength training program for 19 weeks . Spontaneous PA energy expenditure ( PAEE ; 3axial accelerometry for 7 days ) , leg and arm strength , and body composition ( dual energy radiograph absorptiometry ) were measured at baseline , after 19 weeks of training intervention , and after 3 months of washout . RESULTS : There were no significant differences between the groups at baseline . In the intervention group , PAEE increased by 10 % from baseline to end of training in boys ( P = .02 ) , but not in girls . Leg and arm strength were increased owing to training intervention in both boys and girls . All other variables were unchanged . Baseline PAEE was significantly negatively correlated with changes of PAEE . CONCLUSIONS : Targeted strength training significantly increases daily spontaneous PA behavior in boys . The less active children showed the greatest increase in spontaneous PAEE . Girls showed a similar increase in strength , but not in spontaneous PAEE . This may be explained by their earlier pubertal development . Strength training may be a promising strategy in schools to counteract decreasing levels of PA The aim of this study was to determine the effectiveness of two different resistance training programs on lower limb explosive and reactive strength in young female athletes . Fifty seven rhythmic gymnasts were r and omly assigned to unspecific resistance training with dumbbells ( 12 repetition maximum squats ) ( n = 19 ; age = 12.0 + /- 1.8 years ) or to specific resistance training with weighted belts ( 6 % of body mass ; n = 18 ; age = 11.9 + /- 1.0 years ) . Squat jump test , counter movement jump test , hopping test , flexibility of the hip , and anthropometric measures were assessed before and after six weeks training . The main result was that both unspecific resistance training and specific resistance training protocol s positively affected the jumping performance , with an increase of the lower limb explosive strength of 6 - 7 % , with no side effects . Counter movement jump flight time increased significantly ( p < 0.01 ) while hopping test ground contact time significantly decreased ( p < 0.01 ) . No significant differences were detected among groups for flexibility , body mass , calf and thigh circumferences . Therefore , six weeks of resistance training that integrates different elements of rhythmic gymnastics training enhance jumping ability in young female athletes Abstract Ramírez-Campillo , R , Gallardo , F , Henriquez-Olguín , C , Meylan , CMP , Martínez , C , Álvarez , C , Caniuqueo , A , Cadore , EL , and Izquierdo , M. Effect of vertical , horizontal , and combined plyometric training on explosive , balance , and endurance performance of young soccer players . J Strength Cond Res 29(7 ) : 1784–1795 , 2015—The aim of this study was to compare the effects of 6 weeks of vertical , horizontal , or combined vertical and horizontal plyometric training on muscle explosive , endurance , and balance performance . Forty young soccer players aged between 10 and 14 years were r and omly divided into control ( CG ; n = 10 ) , vertical plyometric group ( VG ; n = 10 ) , horizontal plyometric group ( HG ; n = 10 ) , and combined vertical and horizontal plyometric group ( VHG ; n = 10 ) . Players performance in the vertical and horizontal countermovement jump with arms , 5 multiple bounds test ( MB5 ) , 20-cm drop jump reactive strength index ( RSI20 ) , maximal kicking velocity ( MKV ) , sprint , change of direction speed ( CODS ) , Yo-Yo intermittent recovery level 1 test ( Yo-Yo IR1 ) , and balance was measured . No significant or meaningful changes in the CG , apart from small change in the Yo-Yo IR1 , were observed while all training programs result ed in meaningful changes in explosive , endurance , and balance performance . However , only VHG showed a statistically significant ( p ⩽ 0.05 ) increase in all performance test and most meaningful training effect difference with the CG across tests . Although no significant differences in performance changes were observed between experimental groups , the VHG program was more effective compared with VG ( i.e. , jumps , MKV , sprint , CODS , and balance performance ) and HG ( i.e. , sprint , CODS , and balance performance ) to small effect . The study demonstrated that vertical , horizontal , and combined vertical and horizontal jumps induced meaningful improvement in explosive actions , balance , and intermittent endurance capacity . However , combining vertical and horizontal drills seems more advantageous to induce greater performance improvements The purpose of this study was to investigate whether 6 weeks of static hamstring stretching effects range of motion ( ROM ) , sprint , and vertical jump performances in athletes . Twenty-one healthy division III women 's track and field athletes participated in the study . Subjects were tested for bilateral knee ROM ; 55-m sprint time ; and vertical jump height before , at 3 weeks , and after the 6-week flexibility program . Subjects were r and omly assigned to treatment and control groups and warmed up with a 10-minute jog on a track before a hamstring stretching protocol . The stretching protocol consisted of four repetitions held for 45 seconds , 4 days per week . Four variables ( left and right leg ROM , 55-m sprint time , vertical jump ) were analyzed using a repeated- measures analysis of variance design . No significant differences ( P ≤ 0.05 ) were found with any of the four variables between the stretching and control groups . Six weeks of a static hamstring stretching protocol did not improve knee ROM or sprint and vertical jump performances in women track and field athletes . The use of static stretching should be restricted to post practice or competition because of the detrimental effects reported throughout the literature . Based on the current investigation , it does not seem that chronic static stretching has a positive or negative impact on athletic performance . Thus , the efficacy of utilizing this practice is question able and requires further investigation The aim of this study was to investigate whether variation in estrogen levels during the menstrual cycle influences susceptibility to exercise-induced muscle damage after stretch-shortening cycle exercise . Physically active women ( n = 18 ; age = 20.2 ± 1.7 yr ) participated in this research . The subjects performed one session of 100 maximal drop jumps on day 1 or 2 of the follicular phase and another identical session on day 1 or 2 of the ovulatory phase ; the order of the sessions was r and omized . Quadriceps femoris muscle peak torque evoked by electrical stimulation and maximal voluntary contraction , muscle pain , and CK activity were measured before and at various times up to 72 h after exercise . It was found that the high estrogen level during the ovulatory phase might be related to an earlier return to baseline muscle strength after strenuous stretch-shortening cycle exercise in that phase compared with the follicular phase . The estrogen effect appears to be highly specific to the damaged site because the differences in most EIMD markers ( CK , soreness , and low-frequency fatigue ) between the two menstrual cycle phases were small Abstract Escamilla , RF , Ionno , M , deMahy , MS , Fleisig , GS , Wilk , KE , Yamashiro , K , Mikla , T , Paulos , L , and And rews , JR . Comparison of three baseball-specific 6-week training programs on throwing velocity in high school baseball players . J Strength Cond Res 26(7 ) : 1767–1781 , 2012 . Throwing velocity is an important baseball performance variable for baseball pitchers , because greater throwing velocity results in less time for hitters to make a decision to swing . Throwing velocity is also an important baseball performance variable for position players , because greater throwing velocity results in decreased time for a runner to advance to the next base . This study compared the effects of 3 baseball-specific 6-week training programs on maximum throwing velocity . Sixty-eight high school baseball players 14–17 years of age were r and omly and equally divided into 3 training groups and a nontraining control group . The 3 training groups were the Throwers Ten ( TT ) , Keiser Pneumatic ( KP ) , and Plyometric ( PLY ) . Each training group trained 3 d·wk−1 for 6 weeks , which comprised approximately 5–10 minutes for warm-up , 45 minutes of resistance training , and 5–10 for cool-down . Throwing velocity was assessed before ( pretest ) and just after ( posttest ) the 6-week training program for all the subjects . A 2-factor repeated measures analysis of variance with post hoc paired t-tests was used to assess throwing velocity differences ( p < 0.05 ) . Compared with pretest throwing velocity values , posttest throwing velocity values were significantly greater in the TT group ( 1.7 % increase ) , the KP group ( 1.2 % increase ) , and the PLY group ( 2.0 % increase ) but not significantly different in the control group . These results demonstrate that all 3 training programs were effective in increasing throwing velocity in high school baseball players , but the results of this study did not demonstrate that 1 resistance training program was more effective than another resistance training program in increasing throwing velocity Abstract Radnor , JM , Lloyd , RS , and Oliver , JL . Individual response to different forms of resistance training in school-aged boys . J Strength Cond Res 31(3 ) : 787–797 , 2017—The aim of this study was to examine individual responses to different forms of resistance training on measures of jumping and sprinting performance in school-aged boys . Eighty boys were categorized into 2 maturity groups ( pre- or post – peak height velocity [ PHV ] ) and r and omly assigned to a plyometric training , resistance training , combined training , or control group . Intervention
Output:
| Therefore , we aim ed at examining comparative intervention studies that assessed the effects of age , sex , maturation , and resistance or plyometric training descriptors ( e.g. , training intensity , volume etc . )
Sex has no major impact on resistance training related outcomes ( e.g. , maximal strength , 10 repetition maximum ) .
In terms of plyometric training , around-PHV boys appear to respond with larger performance improvements ( e.g. , jump height , jump distance ) compared with girls .
Different types of resistance training ( e.g. , body weight , free weights ) are effective in improving measures of muscle strength ( e.g. , maximum voluntary contraction ) in untrained children and adolescents .
Effects of plyometric training in untrained youth primarily follow the principle of training specificity . |
MS213278 | ***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 Treatment of primary acquired cold urticaria ( CU ) is quite difficult because of variable clinical effectiveness and side effects of classic antihistamines . OBJECTIVE The objective of the study was to assess the efficacy and safety of mizolastine , an antihistaminic with antiallergic properties , versus placebo in primary acquired CU . METHODS This study was a phase II , multicenter , r and omized , double-blind , crossover , placebo-controlled study of mizolastine ( 10 mg , once daily ) versus placebo in 28 patients with primary acquired CU . Efficacy was measured by the cold-stimulation time test , the wheal response , and pruritus intensity after an ice-cube test . RESULTS Mizolastine delayed the cold-induced wheal reaction , reduced wheal response at 3 and 10 minutes , and reduced pruritus intensity . Statistically significant differences were observed versus placebo for the cold-stimulation time test , wheal response at 3 and 10 minutes , and pruritus intensity ( P = .006,.015,.009 , and .005 , respectively ) . No clinical ly relevant adverse events were reported . CONCLUSIONS Mizolastine ( 10 mg , once daily ) was shown to be superior to placebo for both delaying and reducing the cold-induced wheal reaction without significant adverse events . Results suggest that mizolastine may be effective in the treatment of CU BACKGROUND Patients with acquired cold urticaria ( ACU ) show itchy wheals during cold exposure . This disturbing condition involves histamine and platelet-activating factor in its pathogenesis . Rupatadine is a dual antagonist of both histamine and platelet-activating factor . OBJECTIVE To assess rupatadine efficacy in preventing reactions to cold challenge in patients with ACU . METHODS A crossover , r and omized , double-blind , placebo-controlled study in which 21 patients with ACU received rupatadine , 20 mg/d , or placebo for 1 week each is presented . The main outcome was the critical stimulation time threshold ( CSTT ) determined by ice cube challenge . Secondary outcomes included CSTT and the critical temperature threshold assessed by a cold provocation device ( TempTest 3.0 ) , as well as scores for wheal reactions , pruritus , burning sensations , and subjective complaints after cold challenge . RESULTS After rupatadine treatment , 11 ( 52 % ) of 21 patients exhibited a complete response ( ie , no urticaria lesions after ice cube provocation ) . A significant improvement in CSTT compared with placebo was observed after ice cube and TempTest 3.0 challenge ( P = .03 and P = .004 , respectively ) . A significant reduction of critical temperature threshold ( P < .001 ) and reduced scores for cold provocation-induced wheal reactions ( P = .01 ) , pruritus ( P = .005 ) , burning sensation ( P = .03 ) , and subjective complaints ( P = .03 ) after rupatadine treatment were also found . Mild fatigue ( n = 4 ) , somnolence ( n = 1 ) , and moderate headache ( n = 1 ) were reported during active treatment . CONCLUSION Rupatadine , 20 mg/d , shows high efficacy and is well tolerated in the treatment of ACU symptoms The efficacy of the new nonsedating antihistamines loratadine and cetirizine was compared in a r and omized , single-blind , crossover , controlled study with that of the classical antihistamines cyproheptadine and ketotifen in seven patients with primary acquired cold urticaria ( ACU ) . The patients received each of the four drugs for 14 consecutive days with a 7-day interval between drugs . We evaluated clinical symptomatology , adverse effects , minimum time of cold contact stimulation required to induce an immediate coalescent wheal ( CSTT ) , and inhibition of histamine-induced wheal response . Both loratadine and cetirizine showed suppression of symptoms with infrequent adverse effects . Important side-effects were observed in patients receiving cyproheptadine . Improvement in CSTT was statistically significant for all drugs compared with baseline values , without differences among them . The histamine-induced skin test was significantly inhibited by all antihistamines . Wheal reductions were 34.6 % for loratadine and 50.9 % for cetirizine . This study suggests that both loratadine and cetirizine may be effective in the treatment of primary ACU A double-blind , crossover trial with a new triprolidine derivative , acrivastine ( BW 825C ; 8 mg 3 times daily ) , cyproheptadine ( 4 mg 3 times daily ) and placebo was carried out in 18 patients suffering from idiopathic cold urticaria . Acrivastine and cyproheptadine significantly ( p less than 0.01 ) reduced weal areas following ice cube challenge when compared to placebo . Acrivastine was found to be significantly more effective ( p less than 0.01 ) than cyproheptadine in reducing weal areas . Furthermore , cyproheptadine caused significantly more drowsiness than acrivastine ( p = 0.021 ) or placebo ( p = 0.013 ) , which did not differ from each other . This study shows that acrivastine is an effective agent in the treatment of cold urticaria and suggests that acrivastine in the dose used lacks adverse effects , such as drowsiness , traditionally associated with antihistamine therapy Eleven patients with primary acquired cold-induced urticaria were treated with ketotifen ( 1 mg b.i.d . ) or placebo in a double-blind , crossover design trial . After seven days of ketotifen treatment , reaction times to a cold stimulus were significantly delayed in ten of the 11 subjects . No effect was seen after placebo treatment . It is concluded that ketotifen may have a place in the treatment of primary acquired cold urticaria The study was performed in 6 Thai children with primary acquired cold urticaria . They all suffered from generalized urticaria and two of them also had angioedema . All of them had normal erythrocyte sedimentation rate , complement 3 and negative VDRL , TPHA , hepatitis B screen and cold agglutinin titer . Cryoglobulin was checked in 3 cases and showed negative results A double-blind cross-over study to compare the effectiveness of cyproheptadine and ketotifen demonstrated that the efficacy of cyproheptadine and ketotifen on clinical symptoms and ice cube test was not significantly different ( p > 0.05 ) . Both of them showed good results in the treatment of cold urticaria with mild side effects . During the follow up , 5 cases showed complete recovery while the other one developed one or two exacerbations per year upon cold exposure . However , the symptoms were mild and subsided on administration of one or two doses of H1 antihistamine . Our data demonstrated that ketotifen was as effective as cyproheptadine in the treatment of cold urticaria in Thai children BACKGROUND Proof-of-concept studies with omalizumab in patients with chronic idiopathic urticaria ( CIU ) have shown significant decreases in mean urticaria activity scores ( UASs ) . OBJECTIVE We sought to evaluate the efficacy and safety of omalizumab in patients with CIU who remain symptomatic despite concomitant H(1)-antihistamine therapy . METHODS This phase II , prospect i ve , double-blind , placebo-controlled , dose-ranging study investigated omalizumab in patients aged 12 to 75 years in the United States and 18 to 75 years in Germany with a UAS over 7 days ( UAS7 ) of 12 or greater despite antihistamine therapy . Patients were r and omized 1:1:1:1 to receive a single subcutaneous dose of 75 , 300 , or 600 mg of omalizumab or placebo added to a stable dose of H(1)-antihistamine . The primary efficacy outcome was change from baseline to week 4 in UAS7 . Patients were followed for an additional 12 weeks to monitor safety . RESULTS Ninety patients from the United States or Germany were enrolled . Both the 300-mg omalizumab group ( -19.9 vs -6.9 , P < .001 ) and the 600-mg omalizumab group ( -14.6 vs -6.9 , P = .047 ) showed greater improvement versus the placebo group in UAS7 . No meaningful difference was observed for the 75-mg omalizumab group . Similar results were seen for key secondary end points of weekly hive and itch scores . Onset of effect occurred after 1 to 2 weeks . Omalizumab was well tolerated , and the incidence of adverse events was similar across treatment groups . CONCLUSION This study demonstrated that a fixed dose of 300 or 600 mg of omalizumab provides rapid and effective treatment of CIU in patients who are symptomatic despite treatment with H(1)-antihistamines Eight subjects with primary -acquired cold urticaria were treated with chlorpheniramine maleate , cyproheptadine hydrochloride , and placebo in a double-blind clinical trial . During three separate seven-day treatment periods , each patient took 4 mg of either active drug or lactose placebo three times a day . Objective measurements were made at the beginning and end of each treatment period by establishing the minimum time ( MT ) of cold stimulus application required to provoke urtication . In addition , the spontaneous appearance of cold urticaria lesions was recorded during each treatment period . The MT required for induction of urtication with a cold stimulus was significantly greater for eight patients receiving cyproheptadine as compared to chlorpheniramine or placebo ( P less than .01 ) . The study demonstrated that cyproheptadine had a significant suppressive action on experimental cold-induced urticaria , while placebo and chlorpheniramine proved ineffective Chronic cold urticaria ( ColdU ) is a rare disease characterized by mast cell-mediated wheals and angioedema following cold exposure . Second-generation H1-antihistamines , such as rupatadine , are the recommended first-line therapy . As of yet , the effects of rupatadine up-dosing on development of ColdU symptom have only been partially characterized . Two-centre , r and omized , double-blind , 3-way crossover , placebo-controlled study in patients with a confirmed ColdU was design ed to assess the effects of up-dosing of rupatadine . A total of 23 patients were r and omized to receive placebo , rupatadine 20 mg/day , and rupatadine 40 mg/day for 1 week . The primary outcome was change in critical temperature thresholds and critical stimulation time thresholds after treatment . Secondary endpoints included assessment of safety and tolerability of rupatadine . Both 20 and 40 mg rupatadine were highly effective in reducing critical temperature thresholds ( p < 0.001 ) and critical stimulation time thresholds ( p < 0.001 ) . In conclusion , rupatadine 20 and 40 mg significantly reduced the development of chronic cold urticaria symptom without an increase in adverse effects BACKGROUND Increased dosing of nonsedating antihistamines is recommended by the current European Academy of Allergology and Clinical Immunology/Global Allergy and Asthma European Network/European Dermatology Forum guidelines on patients with acquired cold urticaria ( ACU ) who do not respond satisfactorily to the st and ard dose . Prospect i ve data supporting this recommendation are scant . OBJECTIVE We sought to assess the effects of 5 and 20 mg of desloratadine and placebo on cold-induced urticarial reactions in patients with ACU . METHODS In this prospect i ve , r and omized , double-blind , 3-way crossover trial , patients with ACU ( n = 30 ) received placebo , 5 mg of desloratadine , and 20 mg of desloratadine every day each for 7 days separated by 14-day washout periods . At the end of each treatment , patients underwent cold provocation with the TempTest 2.0/2.1 system , and urticarial reactions were assessed by using digital 3-dimensional time-lapse photography and thermography ; the critical temperature threshold ( CTT ) and critical stimulation time threshold ( CSTT ) were measured . Adverse events ( AEs ) reported during the study were assessed . RESULTS Compared with placebo , 7 days of desloratadine at 5 and 20 mg/d significantly reduced the volume of cold-induced wheals and areas of hyperthermic skin and improved CTT and CSTT results . Desloratadine at 20 mg/d significantly reduced cold-induced wheal volume and CTT and CSTT values versus desloratadine at 5 mg/d . Desloratadine was well tolerated , with no increased rate of somnolence or other AEs with 20 mg of desloratadine . CONCLUSIONS Desloratadine at st and ard and high doses significantly improved objective signs of ACU provoked by cold exposure . Desloratadine at 4 times the st and ard dose significantly reduced ACU lesion severity versus 5 mg of desloratadine without an increase in AEs . This study supports current guidelines that increased desloratadine dosing might benefit patients with urticaria who do not respond to st and ard doses Background : Omalizumab , a recombinant anti‐IgE antibody , effectively treats chronic spontaneous urticaria .
Output:
| Results Our pooled meta‐analyses showed that nonsedating second‐generation H1‐antihistamines ( nsAHs ) are effective in the treatment of ColdU and that updosing of nsAHs significantly reduced CTTs relative to their own st and ard doses and placebos .
Omalizumab result ed in a marked reduction of CTTs in H1‐antihistamine – resistant patients .
Of 118 adverse events in 8 studies , st and ard‐dose nsAHs , updosed nsAHs , and omalizumab produced lower numbers of adverse events than first‐generation antihistamines .
Conclusions Our study showed that greater dosages of nsAHs were more effective than st and ard dosages in controlling ColdU symptoms .
Increasing the dosages was not significantly associated with higher adverse event rates .
Omalizumab at 150 and 300 mg every 4 weeks was shown to be effective for patients with ColdU refractory to antihistamines |
MS213279 | ***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 Atrial Fibrillation is highly prevalent in clinical practice affecting approximately 2.3 million people in USA and 4.5 million people in European Union . The aim of the study was to examine the association between nut consumption and incident atrial fibrillation . Methods Prospect i ve cohort of 21,054 male participants of Physicians ' Health Study I. Nut consumption was estimated using food frequency question naire and incident atrial fibrillation was ascertained through yearly follow-up question naires . Cox regression was used to estimate relative risks of atrial fibrillation . Results The average age was 54.6 ± 9.5 years ( 40.7 - 87.1 ) . During a mean follow up of 20 years ( median 24 years ) , 3,317 cases of atrial fibrillation occurred . The crude incidence rate was 7.6 , 7.4 , 8.2 , 7.9 , and 6.8 cases/1000 person-years for people reporting nut consumption of rarely/never , 1 - 3/month , 1/per week , 2 - 6/week , and ≥ 7/week , respectively . Multivariable adjusted hazard ratios ( 95 % CI ) for incident atrial fibrillation were 1.00 ( ref ) , 1.00 ( 0.90 - 1.11 ) , 1.09 ( 0.97 - 1.21 ) , 1.07 ( 0.95 - 1.21 ) , and 0.91 ( 0.70 - 1.17 ) for nut consumption from the lowest to the highest category of nut consumption ( p for trend 0.26 ) . No statistically significant association between nut consumption and atrial fibrillation was found when stratified by body mass index ( BMI < 25 vs ≥ 25 kg/m2 ) or age ( < 65 vs. ≥ 65 years ) . Conclusions Our data did not show an association between nut consumption and incident atrial fibrillation among US male physicians BACKGROUND Heart failure is highly prevalent among older adults and is associated with high cost and societal burden . Although previous studies have reported beneficial effects of dietary factors on heart failure predictors , no previous study has examined whether frequent consumption of nuts is associated with a lower risk of heart failure in a large prospect i ve cohort . OBJECTIVE We examined the association between nut consumption and incident heart failure to determine whether such a relation is modified by overweight or obesity . DESIGN This was a prospect i ve cohort study of 20,976 participants from the Physicians ' Health Study I. Nut consumption was assessed with a simple abbreviated food question naire , and self-reported heart failure was ascertained by follow-up question naires . We used Cox regression to estimate relative risks of heart failure . RESULTS After an average follow-up of 19.6 y , 1,093 new cases of heart failure occurred . Nut consumption was not associated with the risk of developing heart failure in this cohort : multivariable adjusted hazard ratios were 1.0 ( reference ) , 0.98 ( 95 % CI : 0.83 , 1.15 ) , 1.06 ( 95 % CI : 0.89 , 1.27 ) , and 1.01 ( 95 % CI : 0.84 , 1.22 ) for nut consumption of < 1 , 1 , and > or = 2 servings/wk , respectively ( P for linear trend : 0.64 ) . The lack of a meaningful relation between nut intake and incident heart failure was seen in both lean and overweight or obese participants ( P for interaction : 0.96 ) . CONCLUSION Our data do not provide evidence for an association between nut consumption and incident heart failure in US male physicians . However , our data can not rule out possible benefits of nut consumption on subtypes of heart failure not prevalent in this cohort Background A number of prospect i ve studies have observed inverse associations between nut consumption and chronic diseases . However , these studies have predominantly been conducted in Western countries , where nut consumption tends to be more common among individuals with healthier lifestyles . It is important to examine the association in other parts of the world , and particularly among population s with different patterns of disease , socioeconomic status , lifestyles and disease risk factors . Our objective was to examine the association between nut consumption and mortality in a population whose nut consumption does not track with a healthy lifestyle . Methods We examined the association between nut consumption and all-cause and cause-specific mortality in the 50 045 participants of the Golestan Cohort Study . Participants were aged 40 and older at baseline in 2004 , and have been actively followed since that time . Dietary data were collected using a vali date d semi-quantitative food frequency question naire that was administered at baseline . Results During 349 677 person-years of follow-up , 3981 cohort participants died , including 1732 women and 2249 men . Nut consumption was associated inversely with all-cause mortality . The pooled multivariate adjusted hazard ratios for death among participants who ate nuts , as compared with those who did not , were 0.89 [ 95 % confidence interval ( CI ) , 0.82 - 0.95 ] for the consumption of less than one serving of nuts per week , 0.75 ( 95 % CI , 0.67 - 0.85 ) for one to less than three servings per week and 0.71 ( 95 % CI , 0.58 - 0.86 ) for three or more servings per week ( P < 0.001 for trend ) . Among specific causes , significant inverse associations were observed between nut consumption and deaths due to cardiovascular disease , all cancers and gastrointestinal cancers . Conclusions This study provides evidence for an inverse association between nut consumption and mortality in a developing country , where nut consumption does not track with a healthy lifestyle . Further work is needed to establish the underlying mechanisms responsible for this association Background Nut consumption has been found to be inversely associated with cardiovascular disease mortality , but the association between nut consumption and incidence of specific cardiovascular diseases is unclear . We examined the association between nut consumption and incidence of seven cardiovascular diseases . Methods This prospect i ve study included 61 364 Swedish adults who had completed a Food Frequency Question naire and were followed up for 17 years through linkage with the Swedish National Patient and Death Registers . Results Nut consumption was inversely associated with risk of myocardial infa rct ion , heart failure , atrial fibrillation and abdominal aortic aneurysm in the age-adjusted and sex-adjusted analysis . However , adjustment for multiple risk factors attenuated these associations and only a linear , dose – response , association with atrial fibrillation ( ptrend=0.004 ) and a non-linear association ( pnon-linearity=0.003 ) with heart failure remained . Compared with no consumption of nuts , the multivariable HRs ( 95 % CI ) of atrial fibrillation across categories of nut consumption were 0.97 ( 0.93 to 1.02 ) for 1–3 times/month , 0.88 ( 0.79 to 0.99 ) for 1–2 times/week and 0.82 ( 0.68 to 0.99 ) for ≥3 times/week . For heart failure , the corresponding HRs ( 95 % CI ) were 0.87 ( 0.80 to 0.94 ) , 0.80 ( 0.67 to 0.97 ) and 0.98 ( 0.76 to 1.27 ) . Nut consumption was not associated with risk of aortic valve stenosis , ischaemic stroke or intracerebral haemorrhage . Conclusions These findings suggest that nut consumption or factors associated with this nutritional behaviour may play a role in reducing the risk of atrial fibrillation and possibly heart failure . Trial registration number NCT01127711 and NCT01127698 ; Results BACKGROUND Prospect i ve studies evaluating associations between food intake and risk of heart failure ( HF ) in diverse population s are needed . OBJECTIVES Relationships between incident HF ( death or hospitalization ) and intake of seven food categories ( whole grains , fruits/vegetables , fish , nuts , high-fat dairy , eggs , red meat ) were investigated in an observational cohort of 14,153 African-American and white adults , age 45 to 64 years , sample d from four US communities . METHODS Between baseline ( 1987 - 1989 ) and Exam 3 ( 1993 - 1995 ) , dietary intake was based on responses to a 66-item food frequency question naire administered at baseline ; thereafter , intake was based on averaged baseline and Exam 3 responses . Hazard ratios ( HR [ 95 % CI ] ) for HF were calculated per 1-daily serving difference in food group intake . RESULTS During a mean of 13 years , 1,140 HF hospitalizations were identified . After multivariable adjustment ( energy intake , demographics , lifestyle factors , prevalent cardiovascular disease , diabetes , hypertension ) , HF risk was lower with greater whole-grain intake ( 0.93 [ 0.87 , 0.99 ] ) , but HF risk was higher with greater intake of eggs ( 1.23 [ 1.08 , 1.41 ] ) and high-fat dairy ( 1.08 [ 1.01 , 1.16 ] ) . These associations remained significant independent of intakes of the five other food categories , which were not associated with HF . CONCLUSIONS In this large , population -based sample of African-American and white adults , whole-grain intake was associated with lower HF risk , whereas intake of eggs and high-fat dairy were associated with greater HF risk after adjustment for several confounders Background / Objectives : There is still a need for scientific evidence about which foods characterize a healthy diet in terms of primary prevention of major chronic diseases . Therefore , we aim ed to give a comprehensive overview on health-related foods , based on 8 years of follow-up of the European Prospect i ve Investigation into Cancer and Nutrition (EPIC)-Potsdam study .Subjects/ Methods : We used data from 23 531 participants of the EPIC-Potsdam study to analyse the associations between 45 single food groups and risk of major chronic diseases , namely , cardiovascular diseases ( CVD ) , type 2 diabetes and cancer using multivariable-adjusted Cox regression . Habitual dietary intake was assessed at baseline using food-frequency question naires . Incident chronic diseases were determined by self-administered follow-up question naires and medically verified , based on inquiry to treating physicians , cancer registries or through death certificates . Results : During follow-up , 363 incident CVD , 837 type 2 diabetes and 844 cancer cases were identified . Higher intakes of whole-grain bread , raw vegetables , coffee and cakes and cookies were found to be significantly associated with a lower risk of chronic diseases . Conversely , higher intakes of low-fat dairy , butter , red meat and sauce were associated with higher risks of chronic diseases . Conclusion : Overall , a healthy diet was characterized by a high consumption of whole-grain bread , raw vegetables and a low consumption of red meat and possibly butter , which is generally in line with previous findings . The paradoxical findings concerning the potential health benefit of coffee as well as cakes and cookies are interesting and should be investigated further Background Prospect i ve data examining the relationship between dietary protein intake and incident coronary heart disease ( CHD ) are inconclusive . Most evidence is derived from homogenous population s such as health professionals . Large community-based analyses in more diverse sample s are lacking . Methods We studied the association of protein type and major dietary protein sources and risk for incident CHD in 12,066 middle-aged adults ( aged 45–64 at baseline , 1987–1989 ) from four U.S. communities enrolled in the Atherosclerosis Risk in Communities ( ARIC ) Study who were free of diabetes mellitus and cardiovascular disease at baseline . Dietary protein intake was assessed at baseline and after 6 years of follow-up by food frequency question naire . Our primary outcome was adjudicated coronary heart disease events or deaths with following up through December 31 , 2010 . Cox proportional hazard models with multivariable adjustment were used for statistical analyses . Results During a median follow-up of 22 years , there were 1,147 CHD events . In multivariable analyses total , animal and vegetable protein were not associated with an increased risk for CHD before or after adjustment . In food group analyses of major dietary protein sources , protein intake from red and processed meat , dairy products , fish , nuts , eggs , and legumes were not significantly associated with CHD risk . The hazard ratios [ with 95 % confidence intervals ] for risk of CHD across quintiles of protein from poultry were 1.00 [ ref ] , 0.83 [ 0.70–0.99 ] , 0.93 [ 0.75–1.15 ] , 0.88 [ 0.73–1.06 ] , 0.79 [ 0.64–0.98 ] , P for trend = 0.16 ) . Replacement analyses evaluating the association of substituting one source of dietary protein for another or of decreasing protein intake at the expense of carbohydrates or total fats did not show any statistically significant association with CHD risk . Conclusion Based on a large community cohort
Output:
| No association was observed with stroke incidence and heart failure .
This systematic review and meta- analysis revealed a beneficial role of nut consumption in reducing the incidence of , and mortality from , different CVD outcomes |
MS213280 | ***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 compare a four‐ and six‐implant maxillary overdenture after an observation period of 5 years . Material and methods Fifty subjects with functional problems concerning their maxillary denture , who had ample bone volume in the anterior region to place four or six implants , were included and r and omly assigned to either group . Implant and overdenture survival , clinical performance , marginal bone loss and patient satisfaction were assessed . Results Forty‐six patients completed the 5‐year follow‐up . One implant failed in the six implants group ( 99.2 % survival ) and none in the four implants group ( 100 % survival ) . No overdentures had to be replaced during the observation period and the number of complications was limited . Clinical function was good , with no difference in clinical parameters between the groups . Mean marginal bone resorption was 0.50 ± 0.37 and 0.52 ± 0.43 mm in the four and six implant group respectively . Conclusion In patients with functional complaints of their maxillary denture , bar‐supported overdentures on four implants in the anterior maxillary region were not inferior to overdentures supported by six implants after 5 years of function . Implant survival and patient satisfaction were high , clinical parameters favourable , bone loss and complications to the denture were minor in both groups ( Clinical trial registration number : NTR2969 ) OBJECTIVE Comparing treatment outcome of four and six bar-connected implants in the anterior maxillary region to support an overdenture during a 1-year follow-up period . MATERIAL AND METHODS Fifty edentulous patients with lack of retention and stability of the upper denture , but with sufficient bone volume to place implants in the anterior maxillary region , were selected . R and omization assigned patients to either four or six implants . Implant survival , overdenture survival , clinical scores , radiographic bone height changes , and patients ' satisfaction were assessed . RESULTS Forty-nine patients ( one drop out ) completed the 1-year follow-up . After 1 year , implant survival was 100 % in the four implants group and 99.3 % in the six implants group ( one implant lost ) . Overdenture survival was 100 % in both groups . Mean clinical scores were low and did not differ between groups ( independent Student 's t-test ) . Mean marginal bone resorption was 0.24 ± 0.32 mm in the four implants group and 0.25 ± 0.29 mm in the six implants group . Patients ' satisfaction had improved in both groups ( paired Student 's t-test ) . CONCLUSION Bar-supported overdentures on four implants in the anterior maxillary region are not inferior to overdentures supported by six bar-connected implants . Implant survival was high , peri-implant conditions were healthy and patients ' satisfaction had increased significantly in both groups PURPOSE To analyze maintenance service of fixed maxillary prostheses and overdentures based on conventional gold bars or titanium bars and frameworks fabricated with computer-aided design /computer-assisted manufacture ( CAD/CAM ) technology . MATERIAL S AND METHODS Forty-one patients participated ; 16 received an implant overdenture with a gold bar ( gold OD ) , 12 received a CAD/CAM-fabricated implant OD with a titanium bar ( Ti OD ) , and 13 received a CAD/CAM implant-supported fixed prosthesis ( IFP ) . The bars and frameworks were screw-retained at the implant level . Maintenance service performed during the first 2 years was recorded and compared between the three groups . After this 2-year period , the Oral Health Impact Profile ( OHIP ) was administered . RESULTS For ODs ( gold , Ti ) most service consisted of activation of the matrices . Fractures of matrices and bar extensions occurred only in the gold OD group , and 65 % of these patients exhibited hyperplasia of the peri-implant mucosa . The maintenance rates were 1.24 ( gold OD ) , 1.36 ( Ti OD ) , and 0.98 ( IFP ) . These differences were not statistically significant . Retightening of occlusal screws was not necessary in any group . The probability that a complication occurred in the first year was high ( 60 % to 70 % ) and statistically not different between the three groups . The probability that a second complication occurred was significantly lower for the IFP group versus the gold OD group . The mean OHIP values were 1.7 ( IFP ) , 6.7 ( gold OD ) , and 7.3 ( Ti OD ) ; ratings in the IFP group were significantly better . CONCLUSIONS Maintenance service was typical for implant prostheses in the edentulous maxilla . Direct screw retention at the implant level without abutments had a favorable effect in all groups . A trend toward a reduction in problems was observed with the CAD/CAM superstructures . The OHIP confirmed high satisfaction , but quality of life appeared to be slightly higher with fixed prostheses In this prospect i ve multicenter study , non-submerged ITI implants were followed in order to evaluate their long-term prognosis in fully edentulous jaws . A total of 1286 implants were inserted in 233 consecutive patients and , after a healing period of three to six months , the successfully integrated implants were restored with 163 overdentures and 95 fixed full-arch bridges . This prospect i ve study not only calculated the 10-year cumulative survival and success rates for the 1286 implants by life table analysis , but also evaluated the actual survival and success rates for 498 implants after at least five years of functional loading . In addition , cumulative success rates were calculated for implant subgroups according to implant length and location . Additional analyses were performed to evaluate the estimated and actual survival and success rates of the implants in relation to various prosthetic rehabilitation techniques . The 10-year cumulative survival and success rates were 95.9 % and 92.7 % , respectively . The actual 5-year survival and success rates of the first 498 implants that were inserted were 97.7 % and 95.0 % , respectively . The analysis of implant subgroups showed slightly more favourable cumulative success rates for 12 mm long implants ( 93 % ) , in comparison to 10 mm and 8 mm long implants ( 91.6 % and 89.6 % , respectively ) . The cumulative success rate for m and ibular implants ( approximately 94 % ) was also more favourable than that for maxillary implants ( approximately 91 % ) . Patients who were loaded with both maxillary and m and ibular prostheses maintained success rates well above 90 % ; while only implants that were inserted to support maxillary overdentures that were retained by Dolder bars showed a success rate below 90 % OBJECTIVE To compare the treatment outcome of 4 vs. 6 bar-connected implants in the posterior region of the maxilla to support an overdenture during a 1-year follow-up period . MATERIAL S AND METHODS Sixty-six edentulous patients with an insufficient amount of bone volume in the maxilla to place implants were asked to participate in this study . R and omization assigned patients to either 4 or 6 implants . In all patients , a maxillary sinus floor elevation procedure with bone from the iliac crest was performed , and after a 3-month healing period , 4 or 6 dental implants were inserted in the maxillary posterior region in a one-stage procedure . After 3 months of osseointegration , a bar-supported overdenture was constructed . Implant survival , overdenture survival , clinical scores , peri-implant bone height changes and patients ' satisfaction were assessed . Study analysis was performed according a non-inferiority design . RESULTS All patients completed the one-year follow-up . After a functional period of 1-year , implant survival was 100 % in the 4 implants group and 99.5 % in the 6 implants group . Overdenture survival was 100 % in both groups . Mean clinical scores were very low and did not significantly differ between groups . Mean marginal bone resorption was 0.35 ± 0.31 mm and 0.46 ± 0.34 mm in the 4 and 6 implants group , respectively . Patients ' satisfaction improved significantly in both groups , but did not differ between groups . CONCLUSION A bar-supported overdenture on 4 implants in the posterior maxillary region is not inferior to an overdenture supported by 6 bar-connected dental implants PURPOSE To evaluate patient-related outcomes in restoring the edentulous maxilla with an implant overdenture . MATERIAL S AND METHODS A comprehensive systematic review of the literature was conducted . Publications reporting patient-based outcomes with concomitant data on implant and /or prosthetic success were selected using predetermined inclusion criteria that were agreed upon by the two review ers . RESULTS Twenty-three publications related to 20 study cohorts were identified to meet the inclusion criteria for maxillary implant overdentures : two r and omized controlled trials ( RCTs ) , 13 prospect i ve case series including two crossover trials , and five retrospective studies . CONCLUSION An implant overdenture offers a stabilized removable solution for the edentulous maxilla , which provides increased patient satisfaction and quality of life improvement . A palateless design supported by four to six implants with a wide anteroposterior span has been successfully applied in some investigations . A higher failure rate was experienced with machined implants , particularly with short implants ( length < 10 mm ) . Although both splinted and solitary anchorage systems are advocated , maintenance is higher for solitary attachments and inflammation is increased beneath the bars . Long-term maintenance care is essential for all design s. Well- design ed RCTs with larger sample cohorts with longer follow-up periods are required to amplify patient- and clinician-based outcomes Although maxillary implant overdentures are used in oral rehabilitation , different design s have not been compared previously in clinical trials . This crossover trial was design ed to measure differences in patient satisfaction with maxillary long-bar implant overdentures with and without palatal coverage opposed by a fixed m and ibular implant-supported prosthesis . Data were also gathered on new conventional dentures and on maxillary conventional dentures opposed by m and ibular fixed prostheses . Sixteen participants were selected from a population wearing conventional dentures . Fifteen received new upper and lower dentures ( 1 drop-out ) . Four implants were placed in the maxilla and m and ible ( 2 drop-outs ) . A m and ibular fixed prosthesis was inserted in 13 participants , who were then divided into 2 groups . One group ( n = 7 ) received long-bar overdentures with palate , then long-bar overdentures without palate . The other group ( n = 6 ) received the same treatments in the reverse order . Mastication tests and psychometric evaluations using Visual Analog Scales and Categorical Scales were performed throughout the study . General satisfaction was very high with both maxillary implant-supported prostheses , as were ratings of almost all psychosocial and functional variables . There were no significant differences between treatments , suggesting that patients are equally satisfied with long-bar overdentures with and without palate when these are opposed by m and ibular fixed prostheses . However , the ratings given to the maxillary implant prostheses were not significantly higher than for new conventional maxillary prostheses . This suggests that maxillary implant prostheses should not be considered as a general treatment of choice in patients with good bony support for maxillary conventional prostheses PURPOSE To evaluate telescopic crown ( TC ) , bar , and locator attachments used in removable four implant-supported overdentures for patients with edentulous maxillae . MATERIAL S AND METHODS A total of 30 maxillary edentulous patients were enrolled in a 3-year prospect i ve study . Ten patients ( group A ) were treated with overdentures supported by TCs , 10 patients ( group B ) with overdentures supported by bar attachments , and 10 patients ( group C ) with overdentures supported by locator attachments . A total of 120 implants were used to restore oral function . During the 3-year follow-up period , implant survival and success rates , biologic and mechanical complications , prosthodontic maintenance efforts , and patient satisfaction were evaluated . RESULTS All 30 patients were available for the 3-year follow-up and exhibited 100 % implant survival and success rates . Peri-implant marginal bone resorption was not statistically significant for the three groups . There were lower plaque , bleeding , gingiva , and calculus indices in group C compared with groups A and B. The number of prosthodontic maintenance visits revealed eight complications in the TC group , seven complications in the bar group , and four complications in the locator group . However , there were no differences in the clinical effects of the overdentures in the three groups . CONCLUSION Within the limits of this prospect i ve study , it was concluded that the locator system produced superior clinical results compared with the TC and bar attachments in terms of peri-implant hygiene parameters , the frequency of prosthodontic maintenance measures , cost , and ease of denture preparation . However , longer-term prospect i ve studies are required to confirm these results
Output:
| CONCLUSION Within the limits of this systematic review , it can be concluded that the survival rates of implants and overdentures and patient satisfaction with a maxillary overdenture supported by four implants were not influenced by the overdenture design , and no statistical difference was detected between the splinted and unsplinted groups |
MS213281 | ***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: This article describes a second treatment- outcome study of cognitive trauma therapy for battered women with posttraumatic stress disorder ( PTSD ; CTT-BW ) . CTT-BW includes trauma history exploration : PTSD education ; stress management ; exposure to abuse and abuser reminders ; self-monitoring of negative self-talk ; cognitive therapy for guilt ; and modules on self-advocacy , assertiveness , and how to identify perpetrators . One hundred twenty-five ethnically diverse women were r and omly assigned to immediate or delayed CTT-BW . PTSD remitted in 87 % of women who completed CTT-BW , with large reductions in depression and guilt and substantial increases in self-esteem . White and ethnic minority women benefited equally from CTT-BW . Similar treatment outcomes were obtained by male and female therapists and by therapists with different levels of education and training . Gains were maintained at 3- and 6-month follow-ups OBJECTIVE Veterans who served in Operation Enduring Freedom ( OEF ) and Operation Iraqi Freedom ( OIF ) commonly experience alcohol misuse and symptoms of posttraumatic stress disorder ( PTSD ) following their return from deployment to a war zone . We conducted a r and omized clinical trial to evaluate the efficacy of a newly developed , 8-module , self-management web intervention ( VetChange ) based on motivational and cognitive-behavioral principles to reduce alcohol consumption , alcohol-related problems , and PTSD symptoms in returning combat veterans . METHOD Six hundred participants , recruited through targeted Facebook ads , were r and omized to either an Initial Intervention Group ( IIG ; n = 404 ) or a Delayed Intervention Group ( DIG ; n = 196 ) that waited 8 weeks for access to VetChange . Primary outcome measures were Drinks per Drinking Day , Average Weekly Drinks , Percent Heavy Drinking Days , and PTSD symptoms . Intent-to-treat analyses compared changes in outcome measures over time between IIG and DIG as well as within-group changes . RESULTS IIG participants demonstrated greater reductions in drinking ( p < .001 for each measure ) and PTSD symptoms ( p = .009 ) between baseline and end-of-intervention than did DIG participants between baseline and the end of the waiting period . DIG participants showed similar improvements to those in IIG following participation in VetChange . Alcohol problems were also reduced within each group between baseline and 3-month follow-up . CONCLUSIONS Results indicate that VetChange is effective in reducing drinking and PTSD symptoms in OIF/OEF veterans . Further studies of VetChange are needed to assess web-based recruitment and retention methods and to determine VetChange 's effectiveness in demographic and clinical sub- population s of returning veterans AIMS To examine the impact of post-traumatic stress disorder ( PTSD ) on 2-year treatment outcomes for heroin dependence . DESIGN Prospect i ve longitudinal study . PARTICIPANTS Data were obtained from a predominantly treatment seeking sample of 615 dependent heroin users who were followed-up at 3 , 12 and 24 months ( follow-up rates : 89 % , 81 % and 76 % , respectively ) . MEASUREMENTS Outcomes examined include treatment retention and exposure , substance use , general physical and mental health and employment . FINDINGS Despite improvements in substance use , PTSD was associated with continued physical ( beta - 1.69 , SE 0.61 , P < 0.01 ) and mental disability ( beta - 2.07 , SE 0.66 , P < 0.01 ) , and reduced occupational functioning ( OR 0.67 , 95 % CI : 0.48 - 0.93 ) throughout the 2-year follow-up . CONCLUSIONS Although conventional treatment services are successful in producing improvements in substance use and associated disability , the disability associated with PTSD remains . An intervention targeting both heroin dependence and PTSD may help to improve the outcomes of those with PTSD The prevalence of alcohol use disorder ( e.g. , alcohol dependence ; AD ) among individuals with posttraumatic stress disorder ( PTSD ) is quite high , with estimates of 52 % for men and 30 % for women ( Kessler , Sonnega , Bromet , Hughes , & Nelson , 1995 ) . There are several interviews and self-report measures of PTSD with good published psychometric properties , and they are routinely used with comorbid AD and PTSD . However , none of these instruments was vali date d with this population . The current study fills this gap by examining the psychometric properties of the PTSD Symptom Scale-Interview ( PSS-I ) and the self-report PTSD Diagnostic Scale ( PDS ) in individuals diagnosed with current PTSD and AD . Both scales comprised of 17 items provide diagnostic and symptom severity information according to DSM-IV-TR criteria . Participants were 167 individuals who were diagnosed with AD and chronic PTSD and were enrolled in a r and omized controlled treatment study . Results revealed excellent internal consistency of both the PSS-I and the PDS , good test-retest reliability over a 1-month period , and good convergent validity with the SCID . The specificity of the PSS-I diagnosis of PTSD was better than the PDS diagnosis , the latter exhibiting a greater percentage of false positives . In sum , the results showed that the PSS-I and PDS performed well in this population and can be used with confidence to assess PTSD diagnosis and symptom severity BACKGROUND Although women with substance use disorders ( SUDs ) have high rates of trauma and posttraumatic stress , many addiction programs do not offer trauma-specific treatments . One promising intervention is Pennebaker 's expressive writing , which involves daily , 20-minute writing sessions to facilitate disclosure of stressful experiences . METHODS Women ( N = 149 ) in residential treatment completed a r and omized clinical trial comparing expressive writing with control writing . Repeated- measures analysis of variance was used to document change in psychological and physical distress from baseline to 2-week and 1-month follow-ups . Analyses also examined immediate levels of negative affect following expressive writing . RESULTS Expressive writing participants showed greater reductions in posttraumatic symptom severity , depression , and anxiety scores , when compared with control writing participants at the 2-week follow-up . No group differences were found at the 1-month follow-up . Safety data were encouraging : although expressive writing participants showed increased negative affect immediately after each writing session , there were no differences in pre-writing negative affect scores between conditions the following day . By the final writing session , participants were able to write about traumatic/stressful events without having a spike in negative affect . CONCLUSIONS Results suggest that expressive writing may be a brief , safe , low-cost , adjunct to SUD treatment that warrants further study as a strategy for addressing posttraumatic distress in substance-abusing women Addressing affect dysregulation may provide a complementary alternative or adjunctive approach to the empirically supported trauma memory processing models of cognitive behavior therapy ( CBT ) for posttraumatic stress disorder ( PTSD ) . A CBT design ed to enhance affect regulation without trauma memory processing -- trauma affect regulation : guide for education and therapy (TARGET)--was compared to present centered therapy ( PCT ) and wait-list ( WL ) conditions in a r and omized clinical trial with 146 primarily low-income and ethnoracial minority mothers with PTSD . TARGET achieved statistically and clinical ly significant improvement on PTSD and affect regulation measures compared to WL , with more consistent and sustained ( over a 6-month follow-up period ) evidence of improvement than PCT . Drop-out rates ( ~25 % ) were comparable in TARGET and PCT , similar to those previously reported for trauma memory processing CBTs . Symptom worsening was rare ( 2 - 8 % ) and transient . Affect regulation-based CBT without trauma memory processing warrants further research as a potentially efficacious therapy for victimization-related PTSD IMPORTANCE Alcohol dependence comorbid with posttraumatic stress disorder ( PTSD ) has been found to be resistant to treatment . In addition , there is a concern that prolonged exposure therapy for PTSD may exacerbate alcohol use . OBJECTIVE To compare the efficacy of an evidence -based treatment for alcohol dependence ( naltrexone ) plus an evidence -based treatment for PTSD ( prolonged exposure therapy ) , their combination , and supportive counseling . DESIGN , SETTING , AND PARTICIPANTS A single-blind , r and omized clinical trial of 165 participants with PTSD and alcohol dependence conducted at the University of Pennsylvania and the Philadelphia Veterans Administration . Participant enrollment began on February 8 , 2001 , and ended on June 25 , 2009 . Data collection was completed on August 12 , 2010 . INTERVENTIONS Participants were r and omly assigned to ( 1 ) prolonged exposure therapy plus naltrexone ( 100 mg/d ) , ( 2 ) prolonged exposure therapy plus pill placebo , ( 3 ) supportive counseling plus naltrexone ( 100 mg/d ) , or ( 4 ) supportive counseling plus pill placebo . Prolonged exposure therapy was composed of 12 weekly 90-minute sessions followed by 6 biweekly sessions . All participants received supportive counseling . MAIN OUTCOMES AND MEASURES The Timeline Follow-Back Interview and the PTSD Symptom Severity Interview were used to assess the percentage of days drinking alcohol and PTSD severity , respectively , and the Penn Alcohol Craving Scale was used to assess alcohol craving . Independent evaluations occurred prior to treatment ( week 0 ) , at posttreatment ( week 24 ) , and at 6 months after treatment discontinuation ( week 52 ) . RESULTS Participants in all 4 treatment groups had large reductions in the percentage of days drinking ( mean change , -63.9 % [ 95 % CI , -73.6 % to -54.2 % ] for prolonged exposure therapy plus naltrexone ; -63.9 % [ 95 % CI , -73.9 % to -53.8 % ] for prolonged exposure therapy plus placebo ; -69.9 % [ 95 % CI , -78.7 % to -61.2 % ] for supportive counseling plus naltrexone ; and -61.0 % [ 95 % CI , -68.9 % to -53.0 % ] for supportive counseling plus placebo ) . However , those who received naltrexone had lower percentages of days drinking than those who received placebo ( mean difference , 7.93 % ; P = .008 ) . There was also a reduction in PTSD symptoms in all 4 groups , but the main effect of prolonged exposure therapy was not statistically significant . Six months after the end of treatment , participants in all 4 groups had increases in percentage of days drinking . However , those in the prolonged exposure therapy plus naltrexone group had the smallest increases . CONCLUSIONS AND RELEVANCE In this study of patients with alcohol dependence and PTSD , naltrexone treatment result ed in a decrease in the percentage of days drinking . Prolonged exposure therapy was not associated with an exacerbation of alcohol use disorder . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00006489 A cognitive-behavioral therapy ( CBT ) program for posttraumatic stress disorder ( PTSD ) was developed to address its high prevalence in persons with severe mental illness receiving treatment at community mental health centers . CBT was compared with treatment as usual ( TAU ) in a r and omized controlled trial with 108 clients with PTSD and either major mood disorder ( 85 % ) or schizophrenia or schizoaffective disorder ( 15 % ) , of whom 25 % also had borderline personality disorder . Eighty-one percent of clients assigned to CBT participated in the program . Intent-to-treat analyses showed that CBT clients improved significantly more than did clients in TAU at blinded posttreatment and 3- and 6-month follow-up assessment s in PTSD symptoms , other symptoms , perceived health , negative trauma-related beliefs , knowledge about PTSD , and case manager working alliance . The effects of CBT on PTSD were strongest in clients with severe PTSD . Homework completion in CBT predicted greater reductions in symptoms . Changes in trauma-related beliefs in CBT mediated improvements in PTSD . The findings suggest that clients with severe mental illness and PTSD can benefit from CBT , despite severe symptoms , suicidal thinking , psychosis , and vulnerability to hospitalizations Women in drug treatment struggle with co-occurring problems , including trauma and post-traumatic stress disorder ( PTSD ) , which can heighten HIV risk . This study examines the impact of two group therapy interventions on reduction of unprotected sexual occasions ( USO ) among women with substance use disorders ( SUD ) and PTSD . Participants were 346 women recruited from and receiving treatment at six community-based drug treatment programs participating in NIDA ’s Clinical Trials Network . Participants were r and omized to receive 12-sessions of either seeking safety ( SS ) , a cognitive behavioral intervention for women with PTSD and SUD , or women ’s health education ( WHE ) , an attention control psychoeducational group . Participants receiving SS who were at higher sexual risk ( i.e. , at least 12 USO per month ) significantly reduced the number of USO over 12-month follow up compared to WHE . High risk women with co-occurring PTSD and addiction may benefit from treatment addressing coping skills and trauma to reduce HIV risk This r and omized controlled pilot study compared a cognitive-behavioral therapy (
Output:
| There were no data on the effects on drug/alcohol use for individual therapy .
Evidence showed that individual trauma-focused psychological therapy delivered alongside SUD therapy did better than TAU/minimal intervention in reducing PTSD severity post-treatment and at long-term follow-up , but only reduced SUD at long-term follow-up .
There was evidence that fewer participants receiving trauma-focused therapy completed treatment .
There was very little evidence to support use of non-trauma-focused individual- or group-based integrated therapies . |
MS213282 | ***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 The purpose of this study was to develop a new Internet-based computerized cognitive behavior therapy ( iCBT ) program in Manga format , the Japanese cartoon , for workers and to examine the effects of the iCBT program on improving subthreshold depression using a r and omized controlled trial ( RCT ) design among workers employed in private companies in Japan . Method All workers in a company ( n = 290 ) and all workers in three departments ( n = 1,500 ) at the headquarters of another large company were recruited by an invitation e-mail . Participants who fulfilled the inclusion criteria were r and omly allocated to intervention or control groups ( N = 381 for each group ) . A six-week , six-lesson iCBT program using Manga ( Japanese comic ) story was developed . The program included several CBT skills : self-monitoring , cognitive restructuring , assertiveness , problem solving , and relaxation . The intervention group studied the iCBT program at a frequency of one lesson per week . Depression ( Beck Depression Inventory II ; BDI-II ) was assessed as a primary outcome at baseline , and three- and six-month follow-ups for both intervention and control groups were performed . Results The iCBT program showed a significant intervention effect on BDI-II ( t = −1.99 , p<0.05 ) with small effect sizes ( Cohen 's d : −0.16 , 95 % Confidence Interval : −0.32 to 0.00 , at six-month follow-up ) . Conclusions The present study first demonstrated that a computerized cognitive behavior therapy delivered via the Internet was effective in improving depression in the general working population . It seems critical to improve program involvement of participants in order to enhance the effect size of an iCBT program . Trial Registration UMIN Clinical Trials Registry Background Most work sites engage in some form of health promotion programming design ed to improve worker health and reduce health care costs . Although these programs have typically been delivered through combinations of seminars and print material s , workplace health promotion programs are increasingly being delivered through the Internet . Objective The purpose of this research was to evaluate the effectiveness of a Web-based multimedia health promotion program for the workplace , design ed to improve dietary practice s , reduce stress , and increase physical activity . Methods Using a r and omized controlled trial design with pretest-posttest comparisons within each group , 419 employees of a human re sources company were r and omly assigned to the Web-based condition or to a condition that provided print material s on the same topics . All subjects were assessed at pretest and posttest through an online question naire containing multiple measures of health behavior and attitudes . The test period was 3 months . Question naire data were analyzed mainly by analysis of covariance and t tests . Results Retention rates were good for both groups—85 % for the Web-based group and 87 % for the print group . Subjects using the Web-based program performed significantly better than the print group on Attitudes Toward a Healthful Diet ( F1,415 = 7.104 , P = .008 ) and Dietary Stage of Change ( F1,408 = 6.487 , P = .01 ) , but there were no significant group differences on the five other dietary measures . Both groups also showed improvement from pretest to posttest on most dietary measures , as indicated by significant t tests . Within the Web-based group , dosage analyses showed significant effects of the number of times the subject accessed the program on measures of Dietary Self-Efficacy ( F2,203 = 5.270 , P = .003 ) , Attitudes Toward a Healthful Diet ( F2,204 = 2.585 , P = .045 ) , and Dietary Stage of Change ( F2,200 = 4.627 , P = .005 ) . No significant differences were found between the two groups on measures of stress or physical activity , although t tests of pretest-posttest changes indicated that both groups improved on several of these measures . The Web-based group gave significantly higher ratings to the program material s than the print group on all health topics and in their overall evaluation ( F1,410 = 9.808 , P = .002 ) . Conclusions The Web-based program was more effective than print material s in producing improvements in the areas of diet and nutrition but was not more effective in reducing stress or increasing physical activity . The higher ratings given to the Web-based program suggest that workers preferred it to the print material s. Both groups showed numerous pretest-posttest improvements in all health topics , although such improvements might be attributable in part to a Hawthorne effect . Results suggest that a multimedia Web-based program can be a promising means of delivering health promotion material to the workforce , particularly in the area of diet and nutrition Background Depression and anxiety are major causes of absence from work and underperformance in the workplace . Cognitive behavioural therapy ( CBT ) can be effective in treating such problems and online versions offer many practical advantages . The aim of the study was to investigate the effectiveness of a computerized CBT intervention ( MoodGYM ) in a workplace context . Method The study was a phase III two-arm , parallel r and omized controlled trial whose main outcome was total score on the Work and Social Adjustment Scale ( WSAS ) . Depression , anxiety , psychological functioning , costs and acceptability of the online process were also measured . Most data were collected online for 637 participants at baseline , 359 at 6 weeks marking the end of the intervention and 251 participants at 12 weeks post-baseline . Results In both experimental and control groups depression scores improved over 6 weeks but attrition was high . There was no evidence for a difference in the average treatment effect of MoodGYM on the WSAS , nor for a difference in any of the secondary outcomes . Conclusions This study found no evidence that MoodGYM was superior to informational websites in terms of psychological outcomes or service use , although improvement to subthreshold levels of depression was seen in nearly half the patients in both groups Background Work-related stress is highly prevalent among employees and is associated with adverse mental health consequences . Web-based interventions offer the opportunity to deliver effective solutions on a large scale ; however , the evidence is limited and the results conflicting . Objective This r and omized controlled trial evaluated the efficacy of guided Web- and mobile-based stress management training for employees . Methods A total of 264 employees with elevated symptoms of stress ( Perceived Stress Scale-10 , PSS-10≥22 ) were recruited from the general working population and r and omly assigned to an Internet-based stress management intervention ( iSMI ) or waitlist control group . The intervention ( GET.ON Stress ) was based on Lazarus ’s transactional model of stress , consisted of seven sessions , and applied both well-established problem solving and more recently developed emotion regulation strategies . Participants also had the opportunity to request automatic text messages on their mobile phone along with the iSMI . Participants received written feedback on every completed session from an e-coach . The primary outcome was perceived stress ( PSS-10 ) . Web-based self-report assessment s for both groups were scheduled at baseline , 7 weeks , and 6 months . At 12 months , an extended follow-up was carried out for the iSMI group only . Results An intention-to-treat analysis of covariance revealed significantly large effect differences between iSMI and waitlist control groups for perceived stress at posttest ( F 1,261=58.08 , P<.001 ; Cohen ’s d=0.83 ) and at the 6-month follow-up ( F 1,261=80.17 , P<.001 ; Cohen ’s d=1.02 ) . The effects in the iSMI group were maintained at 12-month follow-up . Conclusions This Web- and mobile-based intervention has proven effective in reducing stress in employees in the long term . Internet-based stress management interventions should be further pursued as a valuable alternative to face-to-face interventions . Trial Registration German Clinical Trials Register ( DRKS ) : 00004749 ; http://drks-neu.uniklinik-freiburg.de/ drks_web/setLocale_EN.do ( Archived by WebCite at http://www.webcitation.org/6e8rl98nl PURPOSE Our goal was to evaluate the efficacy of a multimedia support program delivered over the Internet to employed family caregivers of persons with dementia . DESIGN AND METHODS The evaluation of this program involved 299 employed family caregivers participating in a pretest-posttest r and omized clinical trial with a 30-day follow-up and a waitlist control condition . Vali date d instruments include the Center for Epidemiologic Studies -Depression scale , the State-Trait Anxiety Inventory , the Caregiver Strain scale from Benjamin Rose , and Positive Aspects of Caregiving used in the nationwide REACH study . RESULTS Those who viewed Caregiver 's Friend : Dealing with Dementia 30 days postexposure demonstrated significant improvements in depression , anxiety , level and frequency of stress , caregiver strain , self-efficacy , and intention to seek help , as well as perceptions of positive aspects of caregiving . IMPLICATION S Interactive multimedia interventions delivered over the Internet appear to be uniquely suited to provide low-cost , effective , convenient , individually tailored programs that present educational information , cognitive and behavioral skills , and affective learning opportunities . This makes Web-based multimedia a promising avenue for work-life balance programs , employee-assistance providers , and organizations interested in improving family caregiver health and well-being BACKGROUND Depressive disorders are highly prevalent in the working population and are associated with excessive costs . The evidence for effective worker-directed interventions for employees with depressive symptoms is limited . Treating employees with depressive symptoms before sick leave via the Internet could be beneficial and cost saving . OBJECTIVE In this study , we developed and tested the effectiveness of a Web-based guided self-help course for employees with depressive symptoms . We report on the posttreatment effectiveness of the intervention . METHODS This study is a two-arm r and omized controlled trial comparing a Web-based guided self-help course to care as usual ( CAU ) . We recruited employees from 6 different companies via the companies ' intranet and posters . The main inclusion criterion was elevated depressive symptoms as measured by a score of ≥16 on the Center for Epidemiological Studies Depression scale ( CES-D ) . The intervention ( Happy@Work ) was based on problem-solving treatment and cognitive therapy and consisted of 6 weekly lessons . Participants were asked to su bmi t their weekly assignment via the website after completion . They subsequently received feedback from a coach via the website . Self-report question naires on depressive symptoms ( CES-D ; primary outcome ) , anxiety measured by the Hospital Anxiety and Depression Scale ( HADS ) , burnout measured by the Maslach Burnout Inventory ( MBI ) , and work performance measured by the Health and Work Performance Question naire ( HPQ ; secondary outcomes ) were completed at baseline and at posttreatment . RESULTS A total of 231 employees were r and omized to either the intervention group ( n=116 ) or CAU (n=115).The posttreatment assessment was completed by 171 ( 74.0 % ) participants . Both the intervention and the CAU group showed significant improvements in the primary outcome of depressive symptoms , but no differences between the conditions was found ( d=0.16 , 95 % CI -0.10 to 0.41 , P=.29 ) . Significant but small effects in favor of the intervention group were found for anxiety symptoms ( d=0.16 , 95 % CI -0.09 to 0.42 , P=.04 ) and exhaustion ( d=0.17 , 95 % CI -0.09 to 0.43 , P=.02 ) . CONCLUSIONS This study showed that a Web-based guided self-help course for employees with depressive symptoms was not more effective in reducing depressive symptoms among employees than CAU . Large improvements in depressive symptoms in the CAU group were unforeseen and potential explanations are discussed This study evaluated the effectiveness of a computer-based stress management training ( SMT ) program in improving employees ’ psychological well-being and work performance . A total of 12 work units ( N=263 ) were r and omly assigned to either an intervention group ( 8 work units , n=142 ) or to a wait-list control group ( 4 work units , n=121 ) . All participants were requested to answer online question naires assessing psychological well-being as a primary outcome , and coping style , social support , and knowledge about stress management as secondary outcomes at baseline ( T0 ) , immediately after the intervention ( T1 ) , and 2 months after the intervention ( T2 ) . The group × time interaction was tested using a mixed-model repeated measures ANOVA . Results showed a group × time interaction for “ knowledge about stress management ” in the entire sample . Among participants who had more than 3 d of training , a significant group × time interaction was observed for “ problem-solving ” and “ avoidance and suppression ” as well as “ knowledge about stress management . ” Our computer-based stress management program was effective for improving knowledge about stress management . It was also effective for improving coping skills in instances where participants had enough time ( at least 3 d ) to complete all sessions Objective : The objective of this study was to determine whether a mindfulness program , created for the workplace , was both practical and efficacious in decreasing employee stress while enhancing resiliency and well-being . Methods : Participants ( 89 ) recruited from The Dow Chemical Company were selected and r and omly assigned to an online mindfulness intervention ( n = 44 ) or wait-list control ( n = 45 ) . Participants completed the Perceived Stress Scale , the Five Facets of Mindfulness Question naire , the Connor-Davidson Resiliency Scale , and the Shirom Vigor Scale at pre- and postintervention and 6-month follow-up . Results : The results indicated that the mindfulness intervention group had significant decreases in perceived stress as well as increased mindfulness , resiliency , and vigor . Conclusions : This online mindfulness intervention seems to
Output:
| No statistically significant differences were found on either outcome between studies using cognitive behavioral therapy ( CBT ) approaches ( as defined by the authors ) compared with other psychological approaches , offering guidance compared with self-guidance , or recruiting from a targeted workplace population compared with a universal workplace population .
In-depth analysis of the interventions identified by the positive deviance approach suggests that interventions that offer guidance are delivered over a shorter time frame ( 6 to 7 weeks ) , utilize secondary modalities for delivering the interventions and engaging users ( ie , emails and text messages [ short message service , SMS ] ) , and use elements of persuasive technology ( ie , self-monitoring and tailoring ) , which may achieve greater engagement and adherence .
Conclusions This review provides evidence that occupational digital mental health interventions can improve workers ’ psychological well-being and increase work effectiveness . |
MS213283 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
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Input: Background Adherence is crucial for public health program effectiveness , though the benefits of increasing adherence must ultimately be weighed against the associated costs . We sought to determine the relationship between investment in community health worker ( CHW ) home visits and increased attendance at cervical cancer screening appointments in Cape Town , South Africa . Methodology /Principal Findings We conducted an observational study of 5,258 CHW home visits made in 2003–4 as part of a community-based screening program . We estimated the functional relationship between spending on these visits and increased appointment attendance ( adherence ) . Increased adherence was noted after each subsequent CHW visit . The costs of making the CHW visits was based on re source use including both personnel time and vehicle-related expenses valued in 2004 R and . The CHW program cost R194,018 , with 1,576 additional appointments attended . Adherence increased from 74 % to 90 % ; 55 % to 87 % ; 48 % to 77 % ; and 56 % to 80 % for 6- , 12- , 24- , and 36-month appointments . Average per-woman costs increased by R14–R47 . The majority of this increase occurred with the first 2 CHW visits ( 90 % , 83 % , 74 % , and 77 % ; additional cost : R12–R26 ) . Conclusions / Significance We found that study data can be used for program planning , identifying spending levels that achieve adherence targets given budgetary constraints . The results , derived from a single disease program , are retrospective , and should be prospect ively replicated Background .We compared vaccine coverage achieved by 2 different delivery strategies for the quadrivalent human papillomavirus ( HPV ) vaccine in Tanzanian schoolgirls . Methods .In a cluster-r and omized trial of HPV vaccination conducted in Tanzania , 134 primary schools were r and omly assigned to class-based ( girls enrolled in primary school grade [ class ] 6 ) or age-based ( girls born in 1998 ; 67 schools per arm ) vaccine delivery . The primary outcome was coverage by dose . Results .There were 3352 and 2180 eligible girls in schools r and omized to class-based and age-based delivery , respectively . HPV vaccine coverage was 84.7 % for dose 1 , 81.4 % for dose 2 , and 76.1 % for dose 3 . For each dose , coverage was higher in class-based schools than in age-based schools ( dose 1 : 86.4 % vs 82.0 % [ P = .30 ] ; dose 2 : 83.8 % vs 77.8 % [ P = .05 ] ; and dose 3 : 78.7 % vs 72.1 % [ P = .04 ] ) . Vaccine-related adverse events were rare . Reasons for not vaccinating included absenteeism ( 6.3 % ) and parent refusal ( 6.7 % ) . School absenteeism rates prior to vaccination ranged from 8.1 % to 23.5 % . Conclusions .HPV vaccine can be delivered with high coverage in schools in sub-Saharan Africa . Compared with age-based vaccination , class-based vaccination located more eligible pupils and achieved higher coverage . HPV vaccination did not increase absenteeism rates in selected schools . Innovative strategies will be needed to reach out-of-school girls . Clinical Trials Registration . NCT01173900 Objective Human papillomavirus ( HPV ) self-sampling ( Self-HPV ) may be used as a primary cervical cancer screening method in a low re source setting . Our aim was to evaluate whether an educational intervention would improve women 's knowledge and confidence in the Self-HPV method . Method Women aged between 25 and 65 years old , eligible for cervical cancer screening , were r and omly chosen to receive st and ard information ( control group ) or st and ard information followed by educational intervention ( interventional group ) . St and ard information included explanations about what the test detects ( HPV ) , the link between HPV and cervical cancer and how to perform HPV self-sampling . The educational intervention consisted of a culturally tailored video about HPV , cervical cancer , Self-HPV and its relevancy as a screening test . All participants completed a question naire that assessed sociodemographic data , women 's knowledge about cervical cancer and acceptability of Self-HPV . Results A total of 302 women were enrolled in 4 health care centers in Yaoundé and the surrounding countryside . 301 women ( 149 in the “ control group ” and 152 in the “ intervention group ” ) completed the full process and were included into the analysis . Participants who received the educational intervention had a significantly higher knowledge about HPV and cervical cancer than the control group ( p<0.05 ) , but no significant difference on Self-HPV acceptability and confidence in the method was noticed between the two groups . Conclusion Educational intervention promotes an increase in knowledge about HPV and cervical cancer . Further investigation should be conducted to determine if this intervention can be sustained beyond the short term and influences screening behavior . Trials Registration International St and ard R and omised Controlled Trial Number ( IS RCT N ) Register IS RCT Background Cervical cancer is a disease of public health importance affecting many women and contributing to avoidably high levels of cancer deaths in Nigeria . In spite of the relative ease of prevention , the incidence is on the increase . This study aim ed to determine the effect of health education on the awareness , knowledge and perception of cervical cancer and screening among women in rural Nigerian communities . Methods The study design was quasi-experimental . The study was carried out among adult women in Odogbolu ( intervention ) and Ikenne ( control ) local government areas ( LGA ) of Ogun state . Three hundred and fifty ( 350 ) women were selected per group by multistage r and om sampling technique . Data was collected by semi structured interviews with the aid of question naire . The intervention consisted of structured health education based on a movie . Result The intervention raised the level of awareness of cervical cancer and screening to 100 % ( p < 0.0001 ) . The proportion of women with very good knowledge of cervical cancer and screening rose from 2 % to 70.5 % ( χ2 = 503.7 , p < 0.0001 ) while the proportion of those with good perception rose from 5.1 % to 95.1 % ( p < 0.0001 ) . The mean knowledge and mean perception scores were also increased ( p < 0.0001 ) . There was increase in the proportion of women who had undertaken cervical screening from 4.3 % to 8.3 % ( p = 0.038 ) . The major reason stated by the women for not having had cervical screening done was lack of awareness about cervical cancer and screening . There was statistically significant difference between the intervention and control groups concerning their knowledge attitude and practice towards cervical and screening ( p < 0.05 ) after the intervention . Conclusion Multiple media health education based on a movie is effective in creating awareness for and improving the knowledge and perception of adult women about cervical cancer and screening . It also improves the uptake of cervical cancer screening . The creation of awareness is very crucial to the success of a cervical cancer prevention programme BACKGROUND Information about women 's acceptance of new screening methods in Sub-Saharan Africa is limited . The aim of this study was to report on women 's acceptance of human papillomavirus ( HPV ) self-sampling following an educational intervention on cervical cancer and HPV . METHODS Women were recruited from the city of Tiko and a low-income neighborhood of Yaoundé , both in Cameroon . Written and oral instructions about how to perform an unsupervised HPV self- sample were given to participants , who performed the test in a private room . Acceptability of HPV self-sampling was evaluated by question naire . Participants previously screened for cervical cancer by a physician were asked additional questions to assess their personal preferences about HPV self-sampling . RESULTS A sample of 540 women were prospect ively enrolled in the study ; median age was 43 years old ( range 30 - 65 years ) . Participants expressed a high level of acceptance of HPV self-sampling as a screening method following information sessions about cervical cancer and HPV . Most expressed no embarrassment , pain , anxiety , or discomfort ( 95.6 % , 87.8 % , 91.3 % , and 85.0 % , respectively ) during the information sessions . Acceptance of the method had no correlation with education , knowledge , age , or socio-professional class . Eighty-six women ( 16 % ) had a history of previous screening ; they also reported high acceptance of HPV self-sampling . CONCLUSION Educational interventions on cancer and HPV were associated with high acceptability of HPV self-testing by Cameroonian women . Further evaluation of the intervention in a larger sample and using a control group is recommended Background Over 85 % of cervical cancer cases and deaths occur in developing countries . HIV-seropositive women are more likely to develop precancerous lesions that lead to cervical cancer than HIV-negative women . However , the literature on cervical cancer prevention in seropositive women in developing countries has not been review ed . The aim of this study is to systematic ally review cervical cancer prevention modalities available for HIV-seropositive women in developing countries . Methods / design This protocol was developed by following the Preferred Reporting Items for Systematic Review s and Meta-Analyses Protocol s ( PRISMA -P ) statement , and the systematic review will be reported in accordance with the PRISMA guidelines . Embase , MEDLINE , PubMed , CINAHL and Cochrane Library will be search ed from inception up to date of final search , and additional studies will be located through citation and reference list tracking . Eligible studies will be r and omised controlled trials , prospect i ve and retrospective cohort studies , case-control and cross-sectional studies carried out in developing countries . Studies will be included if they are published in English and examine cervical cancer prevention modalities in HIV-seropositive women . Results will be summarised in tables and , where appropriate , combined using meta- analysis . Discussion This review will address the gap in evidence by systematic ally review ing the published literature on the different prevention modalities being used to prevent cervical cancer in HIV-seropositive women in developing countries . The findings may be used to inform evidence -based guidelines for prevention of cervical cancer in seropositive women as well as future research . Systematic review registration PROSPERO CRD42017054678 OBJECTIVE To determine the impact of trained community health educators on the uptake of cervical and breast cancer screening , and HPV vaccination in rural communities in southeast Nigeria . METHODS A prospect i ve population -based intervention study , with a before- and -after design , involved four r and omly selected communities in southeast Nigeria from February 2014 to February 2016 . Before the intervention , baseline data were collected on the uptake of cervical and breast cancer prevention services . The intervention was house-to-house education on cervical cancer and breast cancer prevention . Postintervention outcome measures included the uptake of cervical and breast cancer screening , and HPV vaccination within 6 months of intervention . RESULTS In total , 1327 women were enrolled . Before the intervention , 42 ( 3.2 % ) women had undergone cervical cancer screening ; afterwards , 897 ( 67.6 % ) women had received screening ( P<0.001 ) . Clinical breast examination was performed for 59 ( 4.4 % ) women before and 897 ( 67.6 % ) after the intervention ( P<0.001 ) . Only 2 ( 0.9 % ) of 214 children eligible for HPV vaccination had received the vaccine before versus 71 ( 33.2 % ) after the intervention ( P<0.001 ) . CONCLUSION The use of community health educators for house-to-house cervical and breast cancer prevention education was associated with significant increases in the uptake of cervical cancer screening , clinical breast examination , and HPV vaccination BACKGROUND Cervical cancer is one of the most common forms of carcinoma among women worldwide , accounting for about 12 % of all cancers . Tragically , studies have shown generally low awareness levels on its symptoms , risk factors and prevention . This study evaluated the effect of a health education program on knowledge of cervical cancer amongst women at risk in Africa . METHOD This study was conducted in the city of Lagos , Nigeria , using a multistage sampling technique . Two model markets were chosen by simple r and om sampling method from a total of 10 local governments with model markets . One was design ated the intervention/experimental group while the other was the control . Systematic sampling method was used in selecting 350 women comprising of 175 participants from each model market . A baseline survey on cervical cancer awareness and screening practice s was carried out in both sample groups with the aid of interviewer-administered , structured and pre-tested question naires . Thereafter , respondents in the intervention group received sessions of community-based educational messages on cervical cancer and its prevention . Subsequently , participants in both groups were reassessed to evaluate the effect of the educational program . Data analysis was conducted with Epi-info statistical software . RESULTS Knowledge level was low on cervical cancer at baseline ; only about 15 % and 6.9 % of participants in the intervention and control groups respectively had heard of cervical cancer . The most common sources of information were friends and media prior to the inter
Output:
| While education is important , implementation science literature reveals that education is not as effective in generating change . |
MS213284 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
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Input: Background Sequential analysis enables repeated statistical analyses to be performed throughout a trial recruitment period , while maintaining a pre-specified power and type I error . Thus the trial can be stopped as soon as the information accumulated is considered sufficient to reach a conclusion . Sequential tests are easy to use and their statistical properties are especially suitable to trials with very straightforward objectives such as non-comparative phase II trials . We report on a phase II study based on the triangular test ( TT ) aim ing at assessing the effectiveness of azithromycin in preventing Plasmodium vivax relapses . Methods To test whether the P. vivax relapse rate was either < 12 % or ≥ 45 % in patients treated with azithromycin , a sequential analysis based on the TT was as used . Patients infected with P. vivax were treated with azithromycin , 1.2 g daily , for 7 days . The onset of a relapse infection was monitored . Results Five patients presenting with an acute P. vivax infection were included in the study . All the patients were initially cured . Three patients reported mild gastrointestinal adverse effects . When the third patient relapsed , the sample path crossed the upper boundary of the TT , and the trial was stopped . Conclusions Using the triangular test , with only a small number of patients , we concluded that azithromycin was not effective enough in preventing P. vivax relapses to warrant further evaluation in phase III . It is suggested that a wider use of sequential analysis in phase II anti-infective drugs trials may have financial and ethical benefits BACKGROUND In the Sahel and sub-Sahelian regions of Africa , malaria transmission is highly seasonal . During a short period of high malaria transmission , mortality and morbidity are high in children under age 5 years . We assessed the efficacy of seasonal intermittent preventive treatment-a full dose of antimalarial treatment given at defined times without previous testing for malaria infection . METHODS We did a r and omised , placebo-controlled , double-blind trial of the effect of intermittent preventive treatment on morbidity from malaria in three health-care centres in Niakhar , a rural area of Senegal . 1136 children aged 2 - 59 months received either one dose of artesunate plus one dose of sulfadoxine-pyrimethamine or two placebos on three occasions during the malaria transmission season . The primary outcome was a first or single episode of clinical malaria detected through active or passive case detection . Primary analysis was by intention-to-treat . This study is registered with , number NCT00132561 . FINDINGS During 13 weeks of follow-up , the intervention led to an 86 % ( 95 % CI 80 - 90 ) reduction in the occurrence of clinical episodes of malaria . With passive case detection , protective efficacy against malaria was 86 % ( 77 - 92 ) , and when detected actively was 86 % ( 78 - 91 ) . The incidence of malaria in children on active drugs was 308 episodes per 1000 person-years at risk , whereas in those on placebo it was 2250 episodes per 1000 person-years at risk . 13 children were not included in the intention-to-treat analysis , which was restricted to children who received a first dose of antimalarial or placebo . There was an increase in vomiting in children who received the active drugs , but generally the intervention was well tolerated . INTERPRETATION Intermittent preventive treatment could be highly effective for prevention of malaria in children under 5 years of age living in areas of seasonal malaria infection New drugs are needed for preventing drug-resistant Plasmodium falciparum malaria . The prophylactic efficacy of azithromycin against P. falciparum in malaria-immune Kenyans was 83 % . We conducted a double-blind , placebo-controlled trial to determine the prophylactic efficacy of azithromycin against multidrug-resistant P. falciparum malaria and chloroquine-resistant Plasmodium vivax malaria in Indonesian adults with limited immunity . After radical cure therapy , 300 r and omized subjects received azithromycin ( 148 subjects , 750-mg loading dose followed by 250 mg/d ) , placebo ( 77 ) , or doxycycline ( 75 , 100 mg/d ) . The end point was slide-proven parasitemia . There were 58 P. falciparum and 29 P. vivax prophylaxis failures over 20 weeks . Using incidence rates , the protective efficacy of azithromycin relative to placebo was 71.6 % ( 95 % confidence interval [ CI ] , 50.3 - 83.8 ) against P. falciparum malaria and 98.9 % ( 95 % CI , 93.1 - 99.9 ) against P. vivax malaria . Corresponding figures for doxycycline were 96.3 % ( 95 % CI , 85.4 - 99.6 ) and 98 % ( 95 % CI , 88.0 - 99.9 ) , respectively . Daily azithromycin offered excellent protection against P. vivax malaria but modest protection against P. falciparum malaria Background Individual malaria interventions provide only partial protection in most epidemiological situations . Thus , there is a need to investigate whether combining interventions provides added benefit in reducing mortality and morbidity from malaria . The potential benefits of combining IPT in children ( IPTc ) with home management of malaria ( HMM ) was investigated . Methods During the 2008 malaria transmission season , 1,277 children under five years of age resident in villages within the rural Farafenni demographic surveillance system ( DSS ) in North Bank Region , The Gambia were r and omized to receive monthly IPTc with a single dose of sulphadoxine/pyrimethamine ( SP ) plus three doses of amodiaquine ( AQ ) or SP and AQ placebos given by village health workers ( VHWs ) on three occasions during the months of September , October and November , in a double-blind trial . Children in all study villages who developed an acute febrile illness suggestive of malaria were treated by VHWs who had been taught how to manage malaria with artemether-lumefantrine ( Coartem ™ ) . The primary aims of the project were to determine whether IPTc added significant benefit to HMM and whether VHWs could effectively combine the delivery of both interventions . Results The incidence of clinical attacks of malaria was very low in both study groups . The incidence rate of malaria in children who received IPTc was 0.44 clinical attacks per 1,000 child months at risk while that for control children was 1.32 per 1,000 child months at risk , a protective efficacy of 66 % ( 95 % CI -23 % to 96 % ; p = 0.35 ) . The mean ( st and ard deviation ) haemoglobin concentration at the end of the malaria transmission season was similar in the two treatment groups : 10.2 ( 1.6 ) g/dL in the IPTc group compared to 10.3 ( 1.5 ) g/dL in the placebo group . Coverage with IPTc was high , with 94 % of children receiving all three treatments during the study period . Conclusion Due to the very low incidence of malaria , no firm conclusion can be drawn on the added benefit of IPTc in preventing clinical episodes of malaria among children who had access to HMM in The Gambia . However , the study showed that VHWs can successfully combine provision of HMM with provision of IPTc . Trial Registration Clinical Trials.gov Background Recent studies have shown that intermittent preventive malaria treatment ( IPT ) in infants in areas of stable malaria transmission reduces malaria and severe anaemia incidence . However in most areas malaria morbidity and mortality remain high in older children . Methods To evaluate the effect of seasonal IPT with sulphadoxine pyrimethamine ( SP ) on incidence of malaria disease in area of seasonal transmission , 262 children 6 months-10 years in Kambila , Mali were r and omized to receive either IPT with SP twice at eight weeks interval or no IPT during the transmission season of 2002 and were followed up for 12 months . Subjects were also followed during the subsequent transmission season in 2003 to assess possible rebound effect . Clinical malaria cases were treated with SP and followed to assess the in vivo response during both periods . Results The incidence rate of malaria disease per 1,000 person-months during the first 12 months was 3.2 episodes in the treatment group vs. 5.8 episodes in the control group with age-adjusted Protective Efficacy ( PE ) of 42.5 % ; [ 95 % CI 28.6%–53.8 % ] . When the first 16 weeks of follow up is considered age-adjusted PE was 67.5 % [ 95 % CI 55.3 % – 76.6 % ] . During the subsequent transmission season , the incidence of clinical malaria per 1000 persons-days was similar between the two groups ( 23.0 vs 21.5 episodes , age-adjusted IRR = 1.07 [ 95 % CI , 0.90–1.27 ] ) . No significant difference was detected in in vivo response between the groups during both periods . Conclusion Two malaria intermittent treatments targeting the peak transmission season reduced the annual incidence rate of clinical malaria by 42.5 % in an area with intense seasonal transmission . This simple strategy is likely to be one of the most effectives in reducing malaria burden in such areas .Trial Registration Clinical trials.gov Background Insecticide treated nets ( ITNs ) and indoor residual spraying ( IRS ) are effective vector control tools that protect against malaria . There is conflicting evidence regarding whether using ITNs and IRS in combination provides additional benefit over using either of these methods alone . This study investigated factors that may modify the effect of the combined use of IRS and ITNs compared to using ITNs alone on malaria infection prevalence . Methods Secondary analysis was carried out on data from a cluster r and omised trial in north-west Tanzania . 50 clusters received ITNs from a universal coverage campaign ; of these 25 were r and omly allocated to additionally receive two rounds of IRS in 2012 . In cross-sectional household surveys children 0.5–14 years old were tested for Plasmodium falciparum infections ( PfPR ) two , six and ten months after the first IRS round . Results IRS protected those sleeping under nets ( OR = 0.38 , 95%CI 0.26–0.57 ) and those who did not ( OR = 0.43 , 95%CI 0.29–0.63 ) . The protective effect of IRS was not modified by community level ITN use ( ITN use<50 % , OR = 0.39 , 95%CI 0.26–0.59 ; ITN use > = 50 % , OR = 0.46 , 95%CI 0.28–0.74 ) . The additional protection from IRS was similar in low ( < 10 % PfPR , OR = 0.38 , 95%CI 0.19–0.75 ) and high transmission areas ( ≥10 % PfPR , OR = 0.34 , 95%CI 0.18–0.67 ) . ITN use was protective at the individual-level regardless of whether the village had been sprayed ( OR = 0.83 , 95%CI 0.70–0.98 ) . Living in a sprayed village was protective regardless of whether the individual slept under an ITN last night ( OR = 0.41 , 95%CI 0.29–0.58 ) . Interpretation Implementing IRS in addition to ITNs was beneficial for individuals from villages with a wide range of transmission intensities and net utilisation levels . Net users received additional protection from IRS . ITNs were providing some individual protection , even in this area with high levels of pyrethroid insecticide resistance . These results demonstrate that there is a supplementary benefit of IRS even when ITNs are effective . Trial Registration Clinical Trials.gov A malaria intervention study was carried out using permethrin impregnated bed nets in the south- central part of Irian Jaya with perennial transmission , from April 1993 to April 1995 . Malariometric surveys were carried out periodically for parasite prevalence by species and for spleen rates . Prior to intervention , the percentage of Plasmodium falciparum infected inhabitants was significantly higher in Hiripau , where permethrin-impregnated bed nets were used during the study , than in the placebo-treated control village , Kaugapu . After two years of intervention the situation was reversed and figures higher in the control village ( RR 0.19 , 95 % CI 0.10 - 0.36 , p < 0.0001 ) . Similarly , P. vivax infection rates , 12.4 % in Hiripau vs 5.7 % in Kaugapu in April 1993 . were reversed in April 1995 ( 3.6 % in Hiripau and 11.3 % in Kaugapu , p < 0.001 ) . In the treated village , pre-control hyperendemicity was reduced to a low mesoendemic level ( spleen rate 12.5 % ) during two years of intervention , whereas the level was mesoendemic ( spleen rate 35.2 % ) in the control village . Impregnated bed nets were found an effective intervention both in moderate ( April 1993 through April 1994 , 1,626 mm rainfall ) and high ( April 1994 through April
Output:
| Conclusion Current evidence is strong for the protective effect of ITN interventions in malaria prevention .
Even though ITNs were found to be the only preventive measure with statistical support for their effectiveness , the role of other malaria control measures may be important adjuncts in the global drive to eliminate malaria |
MS213285 | ***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: Abstract Objective : To evaluate the use of a computerised support system for decision making for implementing evidence based clinical guidelines for the management of asthma and angina in adults in primary care . Design : A before and after pragmatic cluster r and omised controlled trial utilising a two by two incomplete block design . Setting : 60 general practice s in north east Engl and . Participants : General practitioners and practice nurses in the study practice s and their patients aged 18 or over with angina or asthma . Main outcome measures : Adherence to the guidelines , based on review of case notes and patient reported generic and condition specific outcome measures . Results : The computerised decision support system had no significant effect on consultation rates , process of care measures ( including prescribing ) , or any patient reported outcomes for either condition . Levels of use of the software were low . Conclusions : No effect was found of computerised evidence based guidelines on the management of asthma or angina in adults in primary care . This was probably due to low levels of use of the software , despite the system being optimised as far as was technically possible . Even if the technical problems of producing a system that fully supports the management of chronic disease were solved , there remains the challenge of integrating the systems into clinical encounters where busy practitioners manage patients with complex , multiple conditions BACKGROUND Although computerized physician order entry reduces medication errors among in patients , little is known about the use of this system in primary care . METHODS We calculated the override rate among 3481 consecutive alerts generated at 5 adult primary care practice s that use a common computerized physician order entry system for prescription writing . For detailed review , we selected a r and om sample of 67 alerts in which physicians did not prescribe an alerted medication and 122 alerts that result ed in a written prescription . We identified factors associated with the physicians ' decisions to override a medication alert , and determined whether an adverse drug event ( ADE ) occurred . RESULTS Physicians overrode 91.2 % of drug allergy and 89.4 % of high-severity drug interaction alerts . In the multivariable analysis using the medical chart review sample ( n = 189 ) , physicians were less likely to prescribe an alerted medication if the prescriber was a house officer ( odds ratio [ OR ] , 0.26 ; 95 % confidence interval [ CI ] , 0.08 - 0.84 ) and if the patient had many drug allergies ( OR , 0.70 ; 95 % CI , 0.53 - 0.93 ) . They were more likely to override alerts for renewals compared with new prescriptions ( OR , 17.74 ; 95 % CI , 5.60 - 56.18 ) . We found no ADEs in cases where physicians observed the alert and 3 ADEs among patients with alert overrides , a nonsignificant difference ( P = .55 ) . Physician review ers judged that 36.5 % of the alerts were inappropriate . CONCLUSIONS Few physicians changed their prescription in response to a drug allergy or interaction alert , and there were few ADEs , suggesting that the threshold for alerting was set too low . Computerized physician order entry systems should suppress alerts for renewals of medication combinations that patients currently tolerate Background : Recent clinical trials indicate that treatment with lipid modifying therapy improves outcomes in patients with ischemic heart disease ( IHD ) and low levels of high density lipoprotein ( HDL ) cholesterol . The results of these trials , however , have not been widely implemented in clinical practice . Objectives : To develop and test an intervention design ed to increase the rate of prescription of lipid modifying therapy and to determine the relative effectiveness of three different prompts ( progress notes , patient letters , or computer chart reminders ) . Methods : The study was conducted in 11 US Department of Veterans Affairs Medical Centers . The effect of the intervention on the proportion of eligible patients receiving lipid modifying therapy was compared between five intervention sites and six matched control sites using a controlled before and after study design . Additionally , 92 providers within the intervention clinics were r and omized to receive one of the three prompts . Data were analyzed using logistic regression modeling which incorporated terms to account for the clustered nature of the data . Results : At the intervention sites the prescription rate increased from 8.3 % during the pre-intervention period to 39.1 % during the intervention ( OR = 6.5 , 95 % CI 5.2 to 8.2 , p<0.0001 ) but remained unchanged at the control sites . The interaction between group ( control v intervention ) and time period was highly significant ( p<0.0001 ) . The adjusted odds of receiving a prescription during the intervention period was 3.1 times higher at the intervention sites than at the control sites ( 95 % CI 2.1 to 4.7 ) . Overall , there was no significant difference in prescription rates among the three prompt groups . However , there was a significant interaction between prompt group and site , indicating that the efficacy of the prompts differed by site . Conclusion : An intervention for primary care providers consisting of an educational workshop , opinion leader influence , and prompts substantially increased the prescription rate of lipid modifying therapy OBJECTIVE The aim of this study was to evaluate the impact of an integrated patient-specific electronic clinical reminder system on diabetes and coronary artery disease ( CAD ) care and to assess physician attitudes toward this reminder system . DESIGN We enrolled 194 primary care physicians caring for 4549 patients with diabetes and 2199 patients with CAD at 20 ambulatory clinics . Clinics were r and omized so that physicians received either evidence -based electronic reminders within their patients ' electronic medical record or usual care . There were five reminders for diabetes care and four reminders for CAD care . MEASUREMENTS The primary outcome was receipt of recommended care for diabetes and CAD . We created a summary outcome to assess the odds of increased compliance with overall diabetes care ( based on five measures ) and overall CAD care ( based on four measures ) . We surveyed physicians to assess attitudes toward the reminder system . RESULTS Baseline adherence rates to all quality measures were low . While electronic reminders increased the odds of recommended diabetes care ( odds ratio [ OR ] 1.30 , 95 % confidence interval [ CI ] 1.01 - 1.67 ) and CAD ( OR 1.25 , 95 % CI 1.01 - 1.55 ) , the impact of individual reminders was variable . A total of three of nine reminders effectively increased rates of recommended care for diabetes or CAD . The majority of physicians ( 76 % ) thought that reminders improved quality of care . CONCLUSION An integrated electronic reminder system result ed in variable improvement in care for diabetes and CAD . These improvements were often limited and quality gaps persist BACKGROUND A cluster r and omized trial of tailored interventions to support the implementation of guidelines for sore throat and urinary tract infection found little or no change in the main outcomes , which were antibiotic prescriptions , use of laboratory tests and use of telephone consultations . There was great variation between the practice s in the change in these outcomes . OBJECTIVES Our aim was to evaluate how the interventions were received and to underst and why practice s did or did not change . METHODS The trial was conducted in general practice s in Norway . Data for this process evaluation were collected from the 120 practice s that completed the trial . Multiple methods were used : observations , semi-structured telephone interviews , a postal survey and data extracted from electronic medical records . We investigated factors that might explain a lack of change , including : agreement with the guidelines ; communication within each practice ; degree of participation in the project ; taking time to discuss the guidelines and their implementation ; use of the components of the interventions ; and routines for telephone consultations . Possible explanatory factors were explored in relation to variation in change and the overall extent of change in rates of use of antibiotics , laboratory tests and telephone consultations . RESULTS Sixty-three per cent of practice s agreed with the guidelines . Only 35 % reported having regular meetings , and 33 % discussed the project before its start , although 75 % reported agreement about participating within the practice . Only 33 % reported meeting to discuss the guidelines . Use of the components of the interventions ranged from 11 % for the increased fee for telephone consultations to 48 % for the computerized decision support . Forty-four per cent reported problems with telephone routines . No single factor explained the observed variation in the extent of change across practice s. CONCLUSIONS Inadequate time , re sources and support were the most salient factors that might explain a lack of change . Problems with internal communication and telephone routines were important contributing factors in many practice 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 Medication errors are frequently related to failure to appropriately select medications or adjust for laboratory parameters . Differences between guideline recommendations and actual frequency of therapeutic laboratory monitoring are substantial . This study evaluated interventions to improve laboratory monitoring at initiation of medication therapy . METHODS This cluster-r and omized trial compared 3 interventions to usual care for 10 medications in 15 primary care clinics in a health maintenance organization with an electronic medical record system . Eligible patients , identified from electronic data bases , had not received recommended laboratory monitoring within 5 days after new dispensing of a study medication . Interventions were an electronic medical record reminder to the prescribing health care professional , an automated voice message to the patient , and a pharmacy team outreach to the patient . Primary outcome was completion of all recommended baseline laboratory monitoring . RESULTS A total of 961 patients participated in the study . At 25 days , 95 ( 48.5 % ) of 196 patients in the electronic medical record reminder group , 177 ( 66.3 % ) of 267 in the automated voice message group , 214 ( 82.0 % ) of 261 in the pharmacy team outreach group , and 53 ( 22.4 % ) of 237 in the usual care group had completed all recommended baseline laboratory monitoring ( P<.001 ) . After adjustments , the hazard ratios for completing laboratory monitoring compared with usual care were 2.5 ( 95 % confidence interval , 1.8 - 3.5 ) for electronic medical record reminder , 4.1 ( 95 % confidence interval , 3.0 - 5.6 ) for automated voice message , and 6.7 ( 95 % confidence interval , 4.9 - 9.0 ) for pharmacy team outreach . CONCLUSIONS All 3 interventions were effective in increasing laboratory monitoring when initiating new medications in primary care . Further work is necessary to determine if these interventions improve patient outcomes Abstract Objective : To underst and the factors influencing the adoption of a computerised clinical decision support system for two chronic diseases in general practice . Design : Practice based , longitudinal , qualitative interview study . Setting : Five general practice s in north east Engl and . Participants : 13 respondents ( two practice managers , three nurses , and eight general practitioners ) gave a total of 19 semistructured interviews . 40 people in practice s included in the r and omised controlled trial ( 34 doctors , three nurses ) and interview study ( three doctors , one previously interviewed ) gave feedback . Results : Negative comments about the decision support system significantly outweighed the positive or neutral comments . Three main areas of concern among clinicians emerged : timing of the guideline trigger , ease of use of the system , and helpfulness of the content . Respondents did not feel that the system fitted well within the general practice context . Experience of “ on-dem and ” information sources , which were generally more positively viewed , informed the comments about the system . Some general practitioners suggested that nurses might find the guideline content more clinical ly useful and might be more prepared to use a computerised decision support system , but lack of feedback from nurses who had experienced the system limited the ability to assess this . Conclusions : Significant barriers exist to the use of complex clinical decision support systems for chronic disease by general practitioners . Key issues include the relevance and accuracy of messages and the flexibility to respond to other factors influencing decision making in primary care . What is already known on this topic R and omised controlled trials of complex computerised decision support systems have found low rates of use and no effects on process and outcomes of care What this study adds Clinicians found a computerised decision support system for chronic disease in general practice to be difficult to use and
Output:
| Further , systems that were endorsed by colleagues , minimized perceived threats to professional autonomy , and did not compromise doctor-patient interactions were accepted by users . |
MS213286 | ***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: One hundred forty‐two patients with all stages of gastric carcinoma were prospect ively stratified into two divisions according to T.N.M. stage following , but irrespective of the type of surgical procedure . Division I ( T 1‐3 , N 1‐2 , M O ) was r and omized into a control group , and a treatment group who received 2000 rad in 8 fractions over 10 days with intravenous 5 Fluorouracil ( 5 F.U. ) at a dose of 500 mg daily × 4 days preirradiation and then 12.5 mg/kg daily for 5 days every 28 days for six courses . Division II ( T4 or M1 ) was r and omized into three groups ; a control group , a group who received radiotherapy and 5 F.U. in the same schedule as division one and a group who received Thiotepa 45 mg intravenously daily for three days and then every 28 days for 6 months . Four and one‐half years after commencement of the trial 86 % of the patients had died . There was no difference in survival rate between the treatment and control groups , ( p > 0.5 ) in Division I or II . Survival appeared to correlate with the T.N.M. stage of disease and not therapy . Blind assessment of the quality of life showed no difference between the treatment groups and the controls . In the dose schedules used , this form of oncological therapy had no efect on survival or quality of life in patients with gastric carcinoma . Cancer 44:385‐391 , 1979 In this prospect ively r and om study , the effect of oral Ftorafur as an adjuvant chemotherapy was compared with that of oral placebo in patients with Stage II and Stage III gastric cancer . Patients had undergone a subtotal gastrectomy with a resection margin that should have been free of tumors . Ftorafur ( 10 mg/kg ) was given daily to 59 Group A patients . Multiple vitamins were given twice a week to 56 Group B patients . We found that there was no statistical significance in Stage II patients with regard to survival . In Stage III patients , those treated with oral Ftorafur had better 3-year and 5-year survival rates than those receiving oral placebo . This preliminary report on this ongoing study seems to indicate that long-term postoperative Ftorafur treatment may be beneficial to Stage III gastric cancer patients PURPOSE The first planned interim analysis ( median follow-up , 3 years ) of the Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer confirmed that the oral fluoropyrimidine derivative S-1 significantly improved overall survival , the primary end point . The results were therefore opened at the recommendation of an independent data and safety monitoring committee . We report 5-year follow-up data on patients enrolled onto the ACTS-GC study . PATIENTS AND METHODS Patients with histologically confirmed stage II or III gastric cancer who underwent gastrectomy with D2 lymphadenectomy were r and omly assigned to receive S-1 after surgery or surgery only . S-1 ( 80 to 120 mg per day ) was given for 4 weeks , followed by 2 weeks of rest . This 6-week cycle was repeated for 1 year . The primary end point was overall survival , and the secondary end points were relapse-free survival and safety . RESULTS The overall survival rate at 5 years was 71.7 % in the S-1 group and 61.1 % in the surgery-only group ( hazard ratio [ HR ] , 0.669 ; 95 % CI , 0.540 to 0.828 ) . The relapse-free survival rate at 5 years was 65.4 % in the S-1 group and 53.1 % in the surgery-only group ( HR , 0.653 ; 95 % CI , 0.537 to 0.793 ) . Subgroup analyses according to principal demographic factors such as sex , age , disease stage , and histologic type showed no interaction between treatment and any characteristic . CONCLUSION On the basis of 5-year follow-up data , postoperative adjuvant therapy with S-1 was confirmed to improve overall survival and relapse-free survival in patients with stage II or III gastric cancer who had undergone D2 gastrectomy Background Despite curative resection , 50%–90 % of gastric cancer patients die of disease relapse . Although some clinical trials have indicated that chemotherapy and immunochemotherapy may be effective modalities , more recent studies have not been able to define the st and ard treatment for advanced gastric cancer . The present study evaluated the effect of adjuvant immunochemotherapy with the use of BCG ( bacille Calmette-Guérin ) and FAM ( 5-fluorouracil , adriamycin , mitomycin C ) chemotherapy on the survival of patients with locally advanced resectable gastric cancer . Methods A total of 156 patients with stage III or IV gastric cancer who had undergone curative resection were r and omly assigned to three treatment groups : BCG + FAM ( immunochemotherapy ) , FAM ( chemotherapy ) , and control ( surgery only ) . Treatment was continued for 2 years or until death . Further postsurgical follow up was carried on for up to 10 years . Results Overall 10-year survival was 47.1 % for the immunochemotherapy group ( P < 0.037 vs FAM and P < 0.0006 vs control ) , 30 % for the chemotherapy group ( vs control , NS ) , and 15.2 % for the control group . In patients with pT2/T3 primary tumors , 10-year survival was 55.3 % for BCG + FAM vs 28.2 % for FAM ( P < 0.01 ) and 14.6 % for the control group ( P < 0.00018 ) . BCG + FAM signifi-cantly improved the survival of patients with intestinal-type but not diffuse-type cancer . Immunochemotherapy was well tolerated . Conclusion This study , based on a limited number of patients , indicates that adjuvant immunochemotherapy ( BCG + FAM ) may prolong the survival of gastric cancer patients after curative gastrectomy ; in particular , in patients with pT2/T3 tumors and intestinal-type primary tumors . There was no survival benefit from FAM adjuvant chemotherapy BACKGROUND AND PURPOSE The role of postoperative chemoradiotherapy in the treatment of patients with gastric cancer with D2 lymph node curative dissection is not well established . In this study , we compared postoperative intensity-modulated radiotherapy plus chemotherapy ( IMRT-C ) with chemotherapy-only in this patient population . MATERIAL S AND METHODS We r and omly assigned patients with D2 lymph node dissection in gastric cancer to IMRT-C or chemotherapy-only groups . The adjuvant IMRT-C consisted of 400 mg of fluorouracil per square meter of body-surface area per day plus 20 mg of leucovorin per square meter of body-surface area per day for 5 days , followed by 45 Gy of IMRT for 5 weeks , with fluorouracil and leucovorin on the first 4 and the last 3 days of radiotherapy . Two 5-day cycles of fluorouracil and leucovorin were given 4 weeks after the completion of IMRT . Chemotherapy-only group was given the same chemotherapy regimens as IMRT-C group . RESULTS The median overall survival ( OS ) in the chemotherapy-only group was 48 months , as compared with 58 months in the IMRT-C group ; the hazard ratio for death was 1.24 ( 95 % confidence interval , 0.94 - 1.65 ; P=0.122 ) . IMRT-C was associated with increases in the median duration of recurrence-free survival ( RFS ) ( 36 months vs. 50 months ) , the hazard ratio for recurrence was 1.35 ( 95 % confidence interval , 1.03 - 1.78 ; P=0.029 ) . COX multivariate regression analysis showed that lymph node metastasis and TNM stage were both the independent prognostic factors . Rates of all grade adverse events were similar in the two treatment groups . CONCLUSIONS IMRT-C improved RFS , but did not significantly improve OS among patients with D2 lymph node dissection in gastric cancer . Using IMRT plus chemotherapy was feasible and well tolerated in patients with gastric cancer after D2 resection BACKGROUND The aim of this study was to determine the efficacy of the EAP regimen ( etoposide , adriamycin and cisplatin ) followed by the Machover schedule ( fluorouracil and folinic acid ) given as adjuvant treatment to patients with poor prognostic factors ( N+ or T3/4 ) . PATIENTS AND METHODS Before r and omisation , the subjects were stratified on the basis of node involvement ( N+ or N- ) and the time from surgery to r and omisation ( < or = 21 days or > 22 days ) . The surgical procedures for sub-total or total gastrectomy with D2 dissection were st and ardised among the participating centres . RESULTS Between December 1992 and December 1997 , 274 patients were enrolled : 137 in the treatment arm and 137 in the control arm . The majority of the patients ( 90 % ) were N+ . After a median follow up of 66 months ( range 2 - 83 ) , the 5-year overall survival ( OS ) was 52 % in the treatment arm and 48 % in the control arm [ hazard ratio ( HR ) 0.93 ; 95 % confidence interval ( CI ) 0.65 - 1.34 ] ; the 5-year disease-free survival ( DFS ) was 49 % and 44 % , respectively ( HR : 0.83 ; 95 % CI 0.59 - 1.17 ) . Among the patients with N-/N+ ( 1 - 6 ) , the 5-year OS was 61 % in the treatment group and 60 % in the control group ; in those with N+ ( 1 - 6 ) , it was 42 % and 22 % . The treatment was completed by 87 % of patients . Drug-related grade 3/4 WHO toxicities included leukopenia ( 21 % ) , nausea and vomiting ( 14 % ) , mucositis ( 9 % ) , neutropenia ( 3 % ) and thrombocytopenia ( 2 % ) . There were two deaths due to sepsis . CONCLUSIONS Although our results are not statistically significant , there was a limited relative risk reduction in the patients receiving adjuvant therapy ( 17 % in DFS and 7 % in OS ) . The data suggest that D2 surgery may have a favourable impact on OS BACKGROUND The aim of this study was to evaluate the efficacy of adjuvant chemotherapy after resection for gastric cancer in a r and omized controlled trial . PATIENTS AND METHODS After curative resection , stage II-III-IVM0 gastric cancer patients were r and omly assigned to postoperative chemotherapy or surgery alone . 5-Fluorouracil ( 5-FU ) 800 mg/m(2 ) daily ( 5-day continuous infusion ) was initiated before day 14 after resection . One month later , four 5-day cycles of 5-FU ( 1 g/m(2 ) per day ) plus cisplatin ( 100 mg/m(2 ) on day 2 ) were administered every 4 weeks . RESULTS The study was closed prematurely after enrollment of 260 patients ( 79.7 % N+ ) , owing to poor accrual . At 97.8 months median follow-up , 5- and 7-year overall survival were 41.9 % and 34.9 % in the control group versus 46.6 % and 44.6 % in the chemotherapy group ( P=0.22 ) . Cox model hazard ratios were 0.74 [ 95 % confidence interval ( CI ) 0.54 - 1.02 ; P=0.063 ] for death and 0.70 ( 95 % CI 0.51 - 0.97 ; P=0.032 ) for recurrence . An invaded/removed lymph nodes ratio > 0.3 was the main independent poor prognostic factor identified by multivariate analysis ( P=0.0001 ) . Because of toxicity , only 48.8 % of patients received more than 80 % of the planned dose . CONCLUSION There was no statistically significant survival benefit with this toxic cisplatin-based adjuvant chemotherapy , but a risk reduction in recurrence was observed After en bloc resection of gastric adenocarcinoma , 180 patients were r and omized to 2 years of 5‐fluorouracil ( 5‐FU ) + semustine ( MeCCNU ) chemotherapy or to observation only . After a median follow‐up time of 64 months , 48 of 89 control patients and 51/91 treated patients recurred ( P < 0.71 ) . The sites of recurrent cancer were similar for both groups : liver , 32 % ; local esophagus or stomach , 51 % ; abdominal nodes and peritoneum , 38 % ; and extra‐abdominal nodes , 14 % . The survival curves overlap ; 51/89 controls and 57/91 treated patients died with a median survival of 32.7 and 36.6 months , respectively ( P < 0.7
Output:
| This study suggests a survival benefit of postoperative ChRT over Ch in patients with resected gastric cancer |
MS213287 | ***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: The purpose of this study was to determine the response to CPT-11 administered every three weeks to adults with progressive malignant glioma , treated with or without enzyme-inducing antiepileptic drug ( EIAED ) therapy , at the recommended phase 2 dose determined from a previous phase 1 study . Adult patients age 18 or older with a KPS of 60 or higher who had measurable recurrent grade III anaplastic glioma ( AG ) or grade IV glioblastoma multiforme ( GBM ) were eligible . No more than one prior chemotherapy was allowed , either as adjuvant therapy or for recurrent disease . The CPT-11 dose was 350 mg/m(2 ) i.v . every three weeks in patients not on EIAED and 750 mg/m(2 ) in patients on EIAED therapy . Patients with stable or responding disease could be treated until tumor progression or a total of 12 months of therapy . The primary end point of the study was to determine whether CPT-11 could significantly delay tumor progression , using the rate of six-month progression-free survival ( PFS-6 ) . The trial was sized to be able to discriminate between a 15 % and 35 % rate for the GBM group alone and between a 20 % and 40 % rate for the entire cohort . There were 51 eligible patients , including 38 GBM and 13 AG patients , enrolled . The median age was 52 and 42 years , respectively . PFS-6 for the entire cohort was 17.6 % . PFS-6 was 15.7 % ( 95 % confidence interval [ CI ] , 0.07 - 0.31 ) for the GBM patients and 23 % ( 95 % CI , 0.07 - 0.52 ) for AG patients . Toxicity for the group included diarrhea and myelosuppression . We conclude that the recommended phase 2 dose of CPT-11 for patients with or without EIAED was ineffective on this schedule , in this patient population Purpose : Although patients with newly diagnosed WHO grade 3 malignant glioma have a more favorable prognosis than those with WHO grade 4 malignant glioma , salvage therapies following recurrence offer essentially palliative benefit . We did a phase II trial of bevacizumab , a monoclonal antibody to vascular endothelial growth factor , in combination with irinotecan for patients with recurrent grade 3 malignant glioma . Experimental Design : Upon documentation of adequate safety among an initial cohort of nine patients treated with bevacizumab ( 10 mg/kg ) and irinotecan every 14 days , a second cohort ( n = 24 ) was treated with bevacizumab ( 15 mg/kg ) every 3 weeks with irinotecan on days 1 , 8 , 22 , and 29 of each 42-day cycle . For both cohorts , the dose of irinotecan was 340 mg/m2 for patients on enzyme-inducing antiepileptic drugs ( EIAED ) and 125 mg/m2 for patients not on EIAEDs . After each 6-week cycle , patients were evaluated with a physical examination and magnetic resonance imaging . Results : The 6-month progression-free survival was 55 % ( 95 % confidence interval , 36 - 70 % ) . The 6-month overall survival was 79 % ( 95 % confidence interval , 61 - 89 % ) . Twenty patients ( 61 % ) had at least a partial response . Outcome did not differ between the two treatment cohorts . Significant adverse events were infrequent and included a central nervous system hemorrhage in one patient , and one patient who developed thrombotic thrombocytopenic purpura . Conclusion : Bevacizumab and irinotecan is an active regimen with acceptable toxicity for patients with recurrent WHO grade 3 malignant glioma PURPOSE Evaluation of treatment effects in malignant brain tumors is challenging because of the lack of reliable response predictors of tumor response . This study examines the predictive value of positron emission tomography ( PET ) using [ 18F ] fluorothymidine ( FLT ) , an imaging biomarker of cell proliferation , in patients with recurrent malignant gliomas treated with bevacizumab in combination with irinotecan . PATIENTS AND METHODS Patients with recurrent malignant gliomas treated with biweekly cycles of bevacizumab and irinotecan were prospect ively studied with FLT-PET at baseline , after 1 to 2 weeks , and after 6 weeks from start of treatment . A more than 25 % reduction in tumor FLT uptake as measured by st and ardized uptake value was defined as a metabolic response . FLT responses were compared with response as shown by magnetic resonance imaging ( MRI ) and patient survival . RESULTS Twenty-one patients were included , and 19 were assessable for metabolic response evaluation with FLT-PET . There were nine responders ( 47 % ) and 10 nonresponders ( 53 % ) . Metabolic responders survived three times as long as nonresponders ( 10.8 v 3.4 months ; P = .003 ) , and tended to have a prolonged progression-free survival ( P = .061 ) . Both early and later FLT-PET responses were more significant predictors of overall survival ( 1 to 2 weeks , P = .006 ; 6 weeks , P = .002 ) , compared with the MRI responses ( P = .060 for both 6-week and best responses ) . CONCLUSION FLT-PET as an imaging biomarker seems to be predictive of overall survival in bevacizumab and irinotecan treatment of recurrent gliomas . Whether FLT-PET performed as early as 1 to 2 week after starting treatment is as predictive as the study indicates at 6 weeks warrants further investigation Our objective is to assess treatment efficacy , safety and pattern of response and recurrence in patients with recurrent high- grade glioma treated with bevacizumab and irinotecan . We review ed retrospectively 51 patients with recurrent high- grade glioma treated with this combination at the Henry Ford Hermelin Brain Tumor Center from 11/15/2005 to 04/01/2008 . The 6-month progression-free survival ( PFS ) for anaplastic gliomas ( AGs ) was 78.6 and 63.7 % for glioblastoma . The median PFS was 13.4 months for AG and 7.6 months for those with glioblastoma . The overall survival rate ( OS ) at 6 months was 85.7 % for AG and 78.0 % for glioblastoma . The 12-month OS was 77.9 % for AG and 42.6 % for glioblastoma . The median OS time for AGs was not reached and was 11.5 months for those with glioblastoma . Thirty-six out of 51 ( 70.59 % ) patients demonstrated partial ( 32/51 ) or complete ( 4/51 ) radiographic response to treatment and 8/51 ( 15.69 % ) remained stable . Of the 38 who demonstrated progression on post-gadolinium studies , 23 showed distant progression with or without local recurrence . Seven patients showed progression on FLAIR without concordant findings on post-Gd sequences . Six patients ( 11.76 % ) discontinued treatment due to a treatment-emergent adverse event , including one with end-stage renal failure and another with gastric perforation . No symptomatic intracranial hemorrhages were reported . Patients with recurrent high- grade glioma treated with bevacizumab plus irinotecan demonstrate an excellent radiographic response rate and improved clinical outcome when compared to historical data . The high rate of distant tumor progression suggests that tumors may adapt to inhibition of angiogenesis by increased infiltration and vascular co-option Purpose : Recurrent grade III-IV gliomas have a dismal prognosis with minimal improvements in survival seen following currently available salvage therapy . This study was conducted to determine if the combination of a novel antiangiogenic therapy , bevacizumab , and a cytotoxic agent , irinotecan , is safe and effective for patients with recurrent grade III-IV glioma . Experimental Design : We conducted a phase II trial of bevacizumab and irinotecan in adults with recurrent grade III-IV glioma . Patients with evidence of intracranial hemorrhage on initial brain magnetic resonance imaging were excluded . Patients were scheduled to receive bevacizumab and irinotecan i.v . every 2 weeks of a 6-week cycle . Bevacizumab was administered at 10 mg/kg . The dose of irinotecan was determined based on antiepileptic use : patients taking enzyme-inducing antiepileptic drugs received 340 mg/m2 , whereas patients not taking enzyme-inducing antiepileptic drugs received 125 mg/m2 . Toxicity and response were assessed . Results : Thirty-two patients were assessed ( 23 with grade IV glioma and 9 with grade III glioma ) . Radiographic responses were noted in 63 % ( 20 of 32 ) of patients ( 14 of 23 grade IV patients and 6 of 9 grade III patients ) . The median progression-free survival was 23 weeks for all patients ( 95 % confidence interval , 15 - 30 weeks ; 20 weeks for grade IV patients and 30 weeks for grade III patients ) . The 6-month progression-free survival probability was 38 % and the 6-month overall survival probability was 72 % . No central nervous system hemorrhages occurred , but three patients developed deep venous thromboses or pulmonary emboli , and one patient had an arterial ischemic stroke . Conclusions : The combination of bevacizumab and irinotecan is an active regimen for recurrent grade III-IV glioma with acceptable toxicity PURPOSE OF REVIEW To critically assess the role of irinotecan ( Camptosar , CPT-11 ) and bevacizumab ( Avastin ) as a new treatment for glioblastoma and other malignant gliomas ( anaplastic forms of astrocytomas and oligodendrogliomas ) . RECENT FINDINGS Two prospect i ve phase II trials of bevacizumab and irinotecan have been reported . The observed high response rates ( 30 - 60 % ) had never been seen in this disease before . Gains in progression-free survival and overall survival ( OS ) were less impressive ( 6-month progression-free survival 30 - 50 % ; median OS : 9 - 10 months ) , but are still superior to historical controls . SUMMARY Bevacizumab is a welcome new weapon in the treatment of malignant gliomas and should be favored as a salvage treatment over cytotoxic chemotherapy for recurrent disease . However , survival results remain far from satisfactory . Once failure to treatment with bevacizumab is diagnosed by conventional radiographic methods , most patients experience rapid deterioration and die shortly afterward . New methods and radiographic criteria for detecting disease progression are needed . Patients willing to explore new treatment strategies through participation in clinical trials should do so prior to starting bevacizumab , as this may not be an option once treatment fails . Cost-effectiveness of bevacizumab in gliomas deserves further investigation . The role of irinotecan in this combination remains unclear . At this time , bevacizumab should only be used in newly diagnosed malignant gliomas in the setting of a clinical trial PURPOSE To evaluate single-agent activity of bevacizumab in patients with recurrent glioblastoma . PATIENTS AND METHODS Patients with recurrent glioblastoma were treated with bevacizumab 10 mg/kg every 2 weeks . After tumor progression , patients were immediately treated with bevacizumab in combination with irinotecan 340 mg/m(2 ) or 125 mg/m(2 ) every 2 weeks , depending on use of enzyme-inducing antiepileptic drugs . Complete patient evaluations were repeated every 4 weeks . RESULTS Forty-eight heavily pretreated patients were accrued to this study . Thromboembolic events ( 12.5 % ) , hypertension ( 12.5 % ) , hypophosphatemia ( 6 % ) , and thrombocytopenia ( 6 % ) were the most common drug-associated adverse events . Six patients ( 12.5 % ) were removed from study for drug-associated toxicity ( five thromboembolic events , one bowel perforation ) . Thirty-four patients ( 71 % ) and 17 patients ( 35 % ) achieved radiographic response based on Levin and Macdonald criteria , respectively . Median progression-free survival ( PFS ) was 16 weeks ( 95 % CI , 12 to 26 weeks ) . The 6-month PFS was 29 % ( 95 % CI , 18 % to 48 % ) . The 6-month overall survival was 57 % ( 95 % CI , 44 % to 75 % ) . Median overall survival was 31 weeks ( 95 % CI , 21 to 54 weeks ) . Early magnetic resonance imaging response ( first 96 hours and 4 weeks ) was predictive of long-term PFS , with the Levin criteria being more predictive than Macdonald criteria . Of 19 patients treated with bevacizumab plus irinotecan at progression , there were no objective radiographic responses . Eighteen patients ( 95 % ) experienced
Output:
| Conclusion The combination of bevacizumab and irinotecan might improve outcome in patients with recurrent malignant glioma . |
MS213288 | ***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 evaluate the short-term efficacy and side effects associated with two methylpheni date hydrochloride ( MPH ) dosing patterns . METHODS Twenty-five boys with attention deficit hyperactivity disorder ( ADHD ) participated in a 5-week , triple-blind , placebo-controlled , crossover evaluation of MPH administered twice ( b.i.d . ) versus thrice ( t.i.d . ) per day ( mean dose = 8.8 + /- 5 mg , .30 + /- .1 mg/kg/dose ) . Four dosing conditions ( placebo , titration [ gradual increase to target dose ] , b.i.d . , and t.i.d . ) were used . Dependent measures obtained on a weekly basis included : parent and teacher ratings of child behavior , parent-child conflicts , parent report of stimulant side effects , child self-report of mood symptoms , a sleep log , laboratory measures of attention , and actigraphic recording of sleep activity . RESULTS All dosing conditions result ed in significant effects on ADHD symptoms when compared with baseline . Relative to placebo , t.i.d . dosing was characterized by improvement on the greatest number of behavioral measures , and both b.i.d . and t.i.d . were generally more effective than titration . Direct comparisons of b.i.d . and t.i.d . dosing revealed that t.i.d . was associated with greater improvement on the Conners Parent Rating Scale Impulsivity/Hyperactivity factor , with a similar marginally significant effect for the ADD-H Teacher Rating Scale Hyperactivity factor . The analysis of clinical ly significant change favored a three-times-a-day dosing schedule over placebo on both parent and teacher ratings of impulsivity/hyperactivity and attention . Compared with placebo , appetite suppression was rated , on average , as more severe in the t.i.d . and titration conditions , but not in the b.i.d . condition . However , the number of subjects who exhibited any or severe appetite suppression did not differ significantly between the b.i.d . and t.i.d . schedules . Although there was no difference in sleep duration for children on b.i.d . and t.i.d . schedules , total sleep time appeared to decrease slightly on t.i.d . relative to placebo according to both parent ratings and actigraphic assessment . There were no significant differences between b.i.d . and t.i.d . on any other side effects or sleep variables . CONCLUSIONS For many children with ADHD , t.i.d . dosing may be optimal . There are few differences in acute side effects between b.i.d . and t.i.d . MPH dosing . The dosing schedule should be selected according to the severity and time course of ADHD symptoms rather than in anticipation of dosing schedule-related side effects Background This study examined augmenting atomoxetine with extended-release methylpheni date in children whose attention-deficit/hyperactivity disorder ( ADHD ) previously failed to respond adequately to stimulant medication . Methods Children with ADHD and prior stimulant treatment ( N = 25 ) received atomoxetine ( 1.2 mg/kg/day ) plus placebo . After 4 weeks , patients who were responders ( n = 4 ) were continued on atomoxetine/placebo while remaining patients were r and omly assigned to either methylpheni date ( ATX/MPH ) ( 1.1 mg/kg/day ) or placebo augmentation ( ATX/PB ) for another 6 weeks . Patients and sites were blind to timing of active augmentation . Safety measures included vital signs , weight , and adverse events . Efficacy was assessed by ADHD rating scales . Results Categorical increases in vital signs occurred for 5 patients ( 3 patients in ATX/MPH , 2 patients in ATX/PBO ) . Sixteen percent discontinued the study due to AE , but no difference between augmentation groups . Atomoxetine treatment was efficacious on outcome measures ( P ≤ .001 ) , but methylpheni date did not enhance response . Conclusion Methylpheni date appears to be safely combined with atomoxetine , but conclusions limited by small sample . With atomoxetine treatment , 43 % of patients achieved normalization on ADHD ratings Abstract Hypotheses concerning unexpected , psychostimulant-related effects reported in previous studies were examined by separating behavioral/physical complaints highly specific to methylpheni date ( MPH ) from those that ( a ) may mimic core/ secondary symptoms of the disorder , or ( b ) are commonly reported by unmedicated children in the general population . Sixty-five children with attention-deficit/hyperactivity disorder ( ADHD ) participated in a double-blind , placebo-controlled , within-subject ( crossover ) experimental design and received a placebo and four MPH doses in counterbalanced order following baseline assessment . Behavioral and physical complaints were significantly higher under baseline relative to placebo and the four immediate-release MPH conditions ( 5 mg , 10 mg , 15 mg , and 20 mg ) across three symptom categories : ADHD core/ secondary symptoms ; symptoms commonly reported in the general population , including unmedicated children with ADHD ; and symptoms highly specific to MPH . No significant differences were found among active drug conditions . Past unexpected findings of psychostimulant effects in ADHD may be due to the inclusion of scale items that reflect core/ secondary features of ADHD and normally occurring behavioral/physical complaints in children OBJECTIVE To evaluate the efficacy and safety of osmotic-release methylpheni date ( OROS-MPH ) compared with placebo for attention-deficit/hyperactivity disorder ( ADHD ) , and the impact on substance treatment outcomes in adolescents concurrently receiving cognitive-behavioral therapy ( CBT ) for substance use disorders ( SUD ) . METHOD This was a 16-week , r and omized , controlled , multi-site trial of OROS-MPH + CBT versus placebo + CBT in 303 adolescents ( aged 13 through 18 years ) meeting DSM-IV diagnostic criteria for ADHD and SUD . Primary outcome measures included the following : for ADHD , clinician-administered ADHD Rating Scale ( ADHD-RS ) , adolescent informant ; for substance use , adolescent-reported days of use in the past 28 days . Secondary outcome measures included parent ADHD-RS and weekly urine drug screens ( UDS ) . RESULTS There were no group differences on reduction in ADHD-RS scores ( OROS-MPH : -19.2 , 95 % confidence interval [ CI ] , -17.1 to -21.2 ; placebo , -21.2 , 95 % CI , -19.1 to -23.2 ) or reduction in days of substance use ( OROS-MPH : -5.7 days , 95 % CI , 4.0 - 7.4 ; placebo : -5.2 days , 95 % CI , 3.5 - 7.0 ) . Some secondary outcomes favored OROS-MPH , including lower parent ADHD-RS scores at 8 ( mean difference = 4.4 , 95 % CI , 0.8 - 7.9 ) and 16 weeks ( mean difference = 6.9 ; 95 % CI , 2.9 - 10.9 ) and more negative UDS in OROS-MPH ( mean = 3.8 ) compared with placebo ( mean = 2.8 ; p = .04 ) . CONCLUSIONS OROS-MPH did not show greater efficacy than placebo for ADHD or on reduction in substance use in adolescents concurrently receiving individual CBT for co-occurring SUD . However , OROS-MPH was relatively well tolerated and was associated with modestly greater clinical improvement on some secondary ADHD and substance outcome measures . Clinical Trial Registration Information-Attention Deficit Hyperactivity Disorder ( ADHD ) in Adolescents with Substance Use Disorders ( SUD ) ; http://www . clinical trials.gov ; NCT00264797 The frequency and severity of 17 side effects presumably associated with stimulant medication were assessed during a rigorous , triple-blind , placebo-controlled , crossover evaluation of methylpheni date , 0.3 and 0.5 mg/kg twice a day , in 83 children with attention deficit hyperactivity disorder . Side effects were rated by parents and teachers at the end of each weekly drug condition . Three children ( 3.6 % ) had side effects that were sufficiently serious to warrant immediate discontinuation of medication . Parent ratings indicated that only the side effects of decreased appetite , insomnia , stomachaches , and headaches increased significantly in frequency and severity during the two active medication doses as compared with the placebo condition . Fewer than half of the children experienced these side effects and among those who did , ratings of mean severity remained in the mild range . Teacher ratings showed little change over drug conditions , except on ratings of staring , sadness , and anxiety , which declined with increasing dose of medication . Parent ratings indicated that only the side effects of decreased appetite , insomnia , stomachaches , and headaches increased significantly in frequency and severity during the two active medication doses as compared with the placebo condition . Fewer than half of the children experienced these side effects and among those who did , ratings of mean severity remained in the mild range . Teacher ratings showed little change over drug conditions , except on ratings of staring , sadness , and anxiety , which declined with increasing dose of medication . Surprisingly , a high frequency of these behavior side effects were reported during the placebo condition . Stimulant medication within this therapeutic range , therefore , results in few , generally mild side effects . ( ABSTRACT TRUNCATED AT 250 WORDS In clinical sample s , juvenile bipolar disorder ( JBPD ) is frequently accompanied by co-morbid attention-deficit/hyperactivity disorder ( ADHD ) . Clinical trials assessing combined psychopharmacological interventions in this population are scarce , and methylpheni date ( MPH ) may worsen manic symptoms . We conducted a r and omized crossover trial with MPH and placebo ( 2 weeks each ) combined with aripiprazole in children and adolescents ( n = 16 ; 8 - 17 years old ) with JBPD and ADHD who had a significant response in manic symptoms with aripiprazole but still presented clinical ly significant symptoms of ADHD . ADHD , manic , and depressive symptoms were assessed by means of st and ard scales . Fourteen out of the 16 subjects completed the trial . No significant differences between the effects of methylpheni date and placebo were detected in ADHD ( F(1 , 43.22 ) = 0.00 ; p = 0.97 ) or manic ( F(1 , 40.19 ) = 0.93 ; p = 0.34 ) symptoms . Significant improvement in depressive symptoms was observed in the MPH group ( F(1,19.03 ) = 7.75 ; p = 0.01 ) according to a secondary self-reported outcome measure . One patient using aripiprazole and MPH discontinued the trial due to the onset of a severe mixed episode . No other significant adverse events were observed . Although MPH did not worsen manic symptoms , it was not more effective than placebo in improving ADHD symptoms in children and adolescents with JBPD co-morbid with ADHD stabilized with aripiprazole . Further investigations are warranted . This study is registered at www . clinical trials.gov under the identifier NCT00305370 OBJECTIVE The purpose of this study was to investigate clinical gains from including both dextroamphetamine and methylpheni date in stimulant trials . METHOD Thirty-six medication-naïve children ages 9 - 14 years diagnosed with attention-deficit/hyperactivity disorder ( ADHD ) were enrolled for 6 weeks in a crossover trial , with 2 weeks of methylpheni date , dextroamphetamine , and placebo , in a r and omly assigned , counterbalanced sequence . Outcome measures constituted a computer-based continuous performance test combined with a motion tracking system ( Qb Test ) and an ADHD question naire rated by parents and teachers . RESULTS Group analyses found significant treatment effects of similar size for the two stimulants on both outcome measures . Single-subject analyses revealed that each stimulant produced a favourable response in 26 children ; however , an individual child frequently responded qualitatively or quantitatively differently to the two stimulants . By including both stimulants in the trial , the number of favorable responders increased from 26 ( 72 % ) to 33 ( 92 % ) . In children with favorable responses of unequal strength to the two stimulants , a shift from inferior drug to best drug was associated with a 64 % mean increase in the overall response strength score , as measured by the ADHD question naire . CONCLUSIONS The likelihood of a favorable response and optimal response strength is increased by including both stimulants in the stimulant trial . The study was first registered in clinical trials 28 September 2010 . Clinical Trials.gov Identifier : NCT01220440 OBJECTIVE To determine the efficacy and safety of clonidine , used alone or in combination with methylpheni date , in treating attention-deficit/hyperactivity disorder ( ADHD ) . METHOD A 16-week , r and omized , double-blind , placebo-controlled clinical trial was conducted in 122 children , ages 7 to 12 , with any subtype of ADHD , r and omly assigned to clonidine , methylpheni date , clonidine in combination with methylpheni date , or placebo according to a 2 x 2 factorial design . In two successive 4-week titration periods , clonidine ( or matching placebo ) and added methylpheni date ( or matching placebo ) were adjusted to optimal doses and then continued for
Output:
| Methylpheni date increases the risks of decreased appetite , weight loss , and abdominal pain in children and adolescents with attention deficit hyperactivity disorder .
No differences in the risks of gastrointestinal adverse events according to type , dose , or duration of administration were found |
MS213289 | ***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 first-episode schizophrenia appear to respond to lower doses of neuroleptics , and to be more sensitive to developing extrapyramidal side-effects . The authors therefore compared in such patients the efficacy and extrapyramidal tolerability of comparatively low dosages of the atypical neuroleptic risperidone and of the conventional neuroleptic haloperidol . Risperidone was hypothesized to have better extrapyramidal tolerability and efficacy in treating negative symptoms . Patients were r and omly assigned under double-blind conditions to receive risperidone ( n=143 ) or haloperidol ( n=146 ) for 8 wk . The primary efficacy criterion was the estimated difference in the mean change in the Positive and Negative Symptom Scale ( PANSS ) negative score between treatment groups ; secondary efficacy criteria were changes on the PANSS total score and other PANSS subscores , and several other measures of psychopathology and general functioning . The primary tolerability criterion was the difference in baseline-adjusted occurrence rates of extrapyramidal side-effects measured with the Simpson-Angus Scale ( SAS ) compared between treatment groups . The main hypothesis was that risperidone would be superior in terms of improving negative symptoms and lowering the risk of extrapyramidal symptoms . Secondary tolerability criteria were the other extrapyramidal symptoms , measured with the Hillside Akathisia Scale ( HAS ) and the Abnormal Involuntary Movement Scale ( AIMS ) . The average mean daily doses were 3.8 mg ( s.d.=1.5 ) for risperidone and 3.7 mg ( s.d.=1.5 ) for haloperidol . There were similar , significant improvements in both treatment groups in the primary and secondary efficacy criteria . At week 8 nearly all scores of extrapyramidal side-effects indicated a significantly higher prevalence of extrapyramidal side-effects with haloperidol than with risperidone [ SAS : risperidone 36.5 % of patients ; haloperidol 51.5 % of patients ; likelihood ratio test , chi2(1)=7.8 , p=0.005 ] . There were significantly fewer drop-outs [ risperidone n=55 , drop-out rate=38.5 % ; haloperidol n=79 , drop-out rate=54.1 % , chi2(1)=7.1 , p=0.009 ] and a longer non-discontinuation time [ risperidone : average of 50.8 d to drop-out ; haloperidol : average of 44.0 d to drop-out ; log rank test , chi2(1)=6.4 , p=0.011 ] in the risperidone group . Risperidone and haloperidol appear to be equally effective in treating negative and other symptoms of first-episode schizophrenia . Risperidone has better extrapyramidal tolerability and treatment retention rate than the equivalent dose of haloperidol in these patients BACKGROUND The differential effects of so-called ' first- and second generation ' antipsychotic medications , when given in the first episode , on the long-term outcome of schizophrenia remain to be eluci date d. AIMS We compared the 9-year outcomes of individuals initially r and omised to clozapine or chlorpromazine . METHOD One-hundred and sixty individuals with treatment-naive , first episode schizophrenia or schizophreniform disorder in a mental health centre in Beijing , China were r and omised to clozapine or chlorpromazine treatment for up to 2 years , followed by up to an additional 7 years of naturalistic treatment . The primary outcome was remission status for individuals in each group . RESULTS Individuals in both groups spent essentially equal amounts of time in each clinical state over the follow-up time period(remission , 78 % ; intermediate , 8 % ; relapse , 14 % ) . There were no significant differences on other measures of illness severity . The clozapine group was more likely than the chlorpromazine group to remain on the medication to which they were originally assigned ( 26 % v. 10 % , P = 0.01 ) . There were no significant differences between the two groups on other secondary efficacy outcomes . CONCLUSIONS These findings support the comparability in effectiveness between antipsychotic medications but with slightly greater tolerability of clozapine in the treatment of first-episode psychosis An international , multicenter , double-blind study was conducted in 183 patients with a first psychotic episode ( provisional schizophreniform disorder or schizophrenia ; DSM-III-R ) treated with flexible doses of risperidone or haloperidol for 6 weeks . At endpoint , 63 percent of risperidone-treated patients and 56 percent of haloperidol-treated patients were clinical ly improved ( > or = 50 % reduction in Positive and Negative Syndrome Scale total scores ) . Risperidone was better tolerated than haloperidol : the severity of extrapyramidal symptoms was significantly lower in the risperidone-treated patients ; significantly fewer risperidone-treated patients required antiparkinsonian medication ; and significantly fewer discontinued treatment because of adverse events . A post hoc analysis revealed that low doses of these antipsychotics were efficacious in some patients . Furthermore , the severity of extrapyramidal symptoms and the use of antiparkinsonian medications were significantly lower in patients receiving low doses ( maximum , < or = 6 mg/day ) than high doses ( maximum , > 6 mg/day ) of risperidone or haloperidol . These findings are consistent with the suggestion that patients with a first psychotic episode may require low doses of antipsychotic medications . Studies design ed specifically to compare low and high doses of antipsychotics are warranted to help optimize treatment for these patients The present study examined basal ganglia volumes in drug-naive first-episode schizophrenic patients before and after treatment with either a specific typical or atypical antipsychotic compound . Sixteen antipsychotic drug-naive and three minimally medicated first-episode schizophrenic patients and 19 matched controls participated . Patients were r and omly assigned to treatment with either low doses of the typical antipsychotic drug , zuclopenthixol , or the atypical compound , risperidone . High-resolution magnetic resonance imaging ( MRI ) scans were obtained in patients before and after 12 weeks of exposure to medication and in controls at baseline . Cau date nucleus , nucleus accumbens , and putamen volumes were measured . Compared with controls , absolute volumes of interest ( VOIs ) were smaller in patients at baseline and increased after treatment . However , with controls for age , gender and whole brain or intracranial volume , the only significant difference between patients and controls was a Hemisphere x Group interaction for the cau date nucleus at baseline , with controls having larger left than right cau date nuclei and patients having marginally larger right than left cau date volumes . Within patients , the two medication groups did not differ significantly with respect to volume changes after 3 months of low dose treatment in any of the VOIs . Nevertheless , when medication groups were examined separately , a significant volume increase in the putamen was evidence d in the risperidone group . The altered asymmetry in cau date volume in patients suggests intrinsic basal ganglia pathology in schizophrenia , most likely of neurodevelopmental origin OBJECTIVE R and omized controlled drug trials have demonstrated that antipsychotic medication is effective to rapidly improve psychotic symptomatology in first-episode psychosis . However , these results may not be generalizable to routine clinical practice . We evaluated the effectiveness , tolerability , and safety of olanza-pine , risperidone , and haloperidol in individuals with first-episode nonaffective psychosis who are representative of clinical practice and who are treated in routine clinical setting s. METHOD 172 patients participated in a practical clinical trial and were r and omly assigned to haloperidol ( N = 56 ) , risperidone ( N = 61 ) , and olanzapine ( N = 55 ) . The mean modal daily doses were 5.4 mg/day for halo-peridol , 4 mg/day for risperidone , and 15.3 mg/day for olanzapine ; 98.3 % of subjects were drug naive at baseline . Data from clinical measures of treatment response and tolerability and safety data from the 6-week acute phase of a large epidemiologic and longitudinal ( February 2001 to February 2005 ) intervention program of first-episode psychosis ( schizophrenia spectrum disorders , DSM-IV criteria ) are reported . RESULTS All 3 treatments showed similar effectiveness in reducing the severity of general , negative , and positive symptomatology after 6 weeks of treatment , as reported by mean change in total Clinical Global Impressions-Severity of Illness scale , Brief Psychiatric Rating Scale ( BPRS ) , Scale for the Assessment of Positive Symptoms , and Scale for the Assessment of Negative Symptoms scores between baseline and 6 weeks . The proportion of study subjects responding , defined as 40 % or greater BPRS total score improvement from baseline , was 57.1 % ( N = 32 of 56 ) haloperidol , 52.5 % ( N = 32 of 61 ) risperidone , and 63.6 % ( N = 35 of 55 ) olanzapine , with no statistical differences among groups . The frequency of extrapyramidal symptoms ( chi(2 ) = 24.519 ; p < .001 ) and concomitant anticholinergic medication use ( chi(2 ) = 57.842 ; p < .0001 ) was greater with haloperidol than olanzapine or risperidone . Olanzapine-treated patients had significantly more weight gain compared with the haloperidol and risperidone groups ( p < .001 ) . CONCLUSION Relatively low doses of haloperidol , risperidone , and olanzapine are equally effective for the acute treatment of first-episode nonaffective psychosis under usual conditions of real clinical practice BACKGROUND Second-generation antipsychotic drugs were introduced over a decade ago for the treatment of schizophrenia ; however , their purported clinical effectiveness compared with first-generation antipsychotic drugs is still debated . We aim ed to compare the effectiveness of second-generation antipsychotic drugs with that of a low dose of haloperidol , in first-episode schizophrenia . METHODS We did an open r and omised controlled trial of haloperidol versus second-generation antipsychotic drugs in 50 sites , in 14 countries . Eligible patients were aged 18 - 40 years , and met diagnostic criteria for schizophrenia , schizophreniform disorder , or schizoaffective disorder . 498 patients were r and omly assigned by a web-based online system to haloperidol ( 1 - 4 mg per day ; n=103 ) , amisulpride ( 200 - 800 mg per day ; n=104 ) , olanzapine ( 5 - 20 mg per day ; n=105 ) , quetiapine ( 200 - 750 mg per day ; n=104 ) , or ziprasidone ( 40 - 160 mg per day ; n=82 ) ; follow-up was at 1 year . The primary outcome measure was all-cause treatment discontinuation . Patients and their treating physicians were not blinded to the assigned treatment . Analysis was by intention to treat . This study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N68736636 . FINDINGS The number of patients who discontinued treatment for any cause within 12 months was 63 ( Kaplan-Meier estimate 72 % ) for haloperidol , 32 ( 40 % ) for amisulpride , 30 ( 33 % ) for olanzapine , 51 ( 53 % ) for quetiapine , and 31 ( 45 % ) for ziprasidone . Comparisons with haloperidol showed lower risks for any-cause discontinuation with amisulpride ( hazard ratio [ HR ] 0.37 , [ 95 % CI 0.24 - 0.57 ] ) , olanzapine ( HR 0.28 [ 0.18 - 0.43 ] ) , quetiapine ( HR 0.52 [ 0.35 - 0.76 ] ) , and ziprasidone ( HR 0.51 [ 0.32 - 0.81 ] ) . However , symptom reductions were virtually the same in all the groups , at around 60 % . INTERPRETATION This pragmatic trial suggests that clinical ly meaningful antipsychotic treatment of first-episode of schizophrenia is achievable , for at least 1 year . However , we can not conclude that second-generation drugs are more efficacious than is haloperidol , since discontinuation rates are not necessarily consistent with symptomatic improvement BACKGROUND The relative effectiveness of second-generation ( atypical ) antipsychotic drugs as compared with that of older agents has been incompletely addressed , though newer agents are currently used far more commonly . We compared a first-generation antipsychotic , perphenazine , with several newer drugs in a double-blind study . METHODS A total of 1493 patients with schizophrenia were recruited at 57 U.S. sites and r and omly assigned to receive olanzapine ( 7.5 to 30 mg per day ) , perphenazine ( 8 to 32 mg per day ) , quetiapine ( 200 to 800 mg per day ) , or risperidone ( 1.5 to 6.0 mg per day ) for up
Output:
| There was little evidence of EPS-differences between SGAs , possibly reflecting use of low doses .
We conclude that SGAs offer an EPS advantage over FGAs in FEP though the evidence largely relates to comparisons with haloperidol . |
MS213290 | ***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: Contrast-induced nephropathy ( CIN ) is an important cause of mortality and morbidity in patients undergoing angiography . This study investigated whether statins decrease incidence of CIN in the setting of percutaneous coronary intervention ( PCI ) and evaluated the influence of such potential benefit on long-term outcome . Four-hundred thirty-four patients undergoing PCI were prospect ively enrolled and followed up to 4 years . Patients were stratified according to preprocedural statin therapy ( 260 statin treated , 174 statin naive ) . CIN was defined as a postprocedural increase in serum creatinine of > or=0.5 mg/dl or>25 % from baseline . Follow-up assessment included 4-year occurrence of major adverse cardiac events . Statin-treated patients had a significantly lower incidence of CIN ( 3 % vs 27 % , p<0.0001 ; 90 % risk decrease ) and had better postprocedural creatinine clearance ( 80+/-20 vs 65+/-16 ml/min , p<0.0001 ) . Benefit of statin before treatment was observed in all subgroups , except in patients with a pre-existing creatinine clearance<40 ml/min . During follow-up , CIN was a predictor of poorer outcome ; 4-year survival free of major adverse cardiac events was highest in statin-treated patients without CIN ( 95 % , p < or=0.015 ) and lowest in statin-naive patients with CIN ( 53 % , p < or=0.018 ) . In conclusion , patients receiving statins before PCI have a significant decrease of CIN ; this early protective effect translates into better long-term event-free survival . These results may lend further support to utilization of statins as adjuvant pharmacologic therapy before PCI Contrast-induced nephropathy limits the outcomes of percutaneous coronary intervention ( PCI ) . The present study compared the protective effects of different statin doses on renal function . A total of 228 patients with acute coronary syndrome undergoing selective PCI were r and omly divided into simvastatin 20-mg group ( S20 , n = 115 ) and simvastatin 80-mg group ( S80 , n = 113 ) . Serum creatinine was measured at admission , the day of PCI , and 24 and 48 hours after PCI . The creatinine clearance was calculated using the Cochcroft-Gault formula . High-sensitive C-reactive protein , P-selectin , and intercellular adhesion molecule-1 were also measured before and after the procedure . Contrast-induced nephropathy was defined as a postprocedure increase in serum creatinine of > or = 0.5 mg/dl or > 25 % from baseline . The serum creatinine significantly increased after PCI , with the peak value occurring at 24 hours , and then began to decrease . At 48 hours , the serum creatinine had decreased to the baseline level in the S80 group , but it had failed to do so in the S20 group . At 24 and 48 hours after PCI , the serum creatinine was lower in the S80 group than in the S20 group ( p < 0.05 and p < 0.001 , respectively ) . The creatinine clearance significantly decreased after PCI , with the lowest value occurring at 24 hours , and then it began to increase . In the S80 group , the creatinine clearance recovered to baseline level at 48 hours , but it failed to do so in the S20 group . The creatinine clearance was greater at 24 and 48 hours in the S80 group than that in the S20 group . Although the procedure caused a significant increase in high-sensitive C-reactive protein , P-selectin , and intercellular adhesion molecule-1 levels , the value was lower in the S80 group than in the S20 group ( p < 0.001 ) . In conclusion , pretreatment with simvastatin 80 mg before PCI could further decrease the occurrence of contrast-induced nephropathy compared with simvastatin 20 mg . This benefit was associated with the lowering of high-sensitive C-reactive protein , P-selectin , and intercellular adhesion molecule-1 levels We investigated the efficacy of short-term high-dose atorvastatin in decreasing the risk of contrast-induced nephropathy ( CIN ) in patients with chronic kidney disease ( CKD ) subjected to coronary angiography and /or angioplasty . CIN occurs in up to 15 % of patients with pre-existing CKD and affects clinical outcome . The protective effect of statin therapy against CIN is still controversial . A prospect i ve , single-center study of 304 patients with baseline estimated creatinine clearance < 60 ml/min were r and omized to receive atorvastatin 80 mg/day or placebo for 48 hours before and 48 hours after contrast medium administration . All patients received intravenous saline hydration and oral N-acetylcysteine 1,200 mg 2 times/day . Iso-osmolar contrast medium was used . CIN was defined as an absolute increase of serum creatinine > or = 0.5 mg/dl within 5 days after the procedure . CIN occurred in 31 patients ( 10 % ) , 16 ( 11 % ) in the placebo group and 15 ( 10 % ) in the atorvastatin group ( p = 0.86 ) . Mean increase in creatinine was not significantly different in the 2 groups ( 0.59 + or - 0.17 in placebo group vs 0.72 + or - 0.26 mg/dl in atorvastatin group , p = 0.31 ) . Persistent kidney injury , defined as 1-month increase from baseline creatinine value > or = 25 % , was observed in 30 % in the placebo group and in 31 % in the atorvastatin group ( p = 0.58 ) . In conclusion , a short-term administration of high doses of atorvastatin before and after contrast exposure , in addition to st and ard intravenous hydration and oral N-acetylcysteine , does not decrease CIN occurrence in patients with pre-existing CKD Objectives : To investigate whether preprocedural high-dose atorvastatin decreases the incidence of contrast-induced nephropathy ( CIN ) and protects the renal function after emergency percutaneous coronary intervention ( PCI ) . Methods : Statin-naive patients with acute ST-segment elevation myocardial infa rct ion ( STEMI ) undergoing emergency PCI ( n = 161 ) r and omly received atorvastatin ( 80 mg , n = 78 , ATOR group ) or placebo [ n = 83 , control ( CON ) group ] followed by long-term atorvastatin ( 40 mg/day ) . The primary end point was incidence of CIN . Results : In the ATOR group , 2.6 % of the patients developed CIN versus 15.7 % in the CON group ( p = 0.01 ) . In the ATOR group , postprocedural serum creatinine was significantly lower ( 93.4 ± 17.1 vs. 112.6 ± 23.3 µmol/l at 48 h and 84.2 ± 14.2 vs. 95.3 ± 17.7 µmol/l at 72 h , both p < 0.0001 ) and in the CON group , peak serum cystatin C was lower ( 0.51 ± 0.14 vs. 0.61 ± 0.13 mg/l , p < 0.0001 ) . Atorvastatin pretreatment was independently associated with a decreased risk of CIN ( OR 0.084 , 95 % CI 0.015–0.462 , p = 0.004 ) . The proportion of alanine aminotransferase > 3 × upper limit of the normal value within 1 month was 3.85 versus 1.20 % ( ATOR vs. CON group , p = 0.57 ) . Conclusion : Preprocedural high-dose atorvastatin prevents CIN and protects the renal function in patients with acute STEMI undergoing emergency PCI Background and aims . Gentamicin ( GM ) is still considered to be an important antibiotic against life-threatening , gram-negative bacterial infections despite its known nephrotoxic effects . We aim ed to evaluate the potential protective effect of atorvastatin ( ATO ) against GM-induced nephrotoxicity in rats . Material s and methods . The rats were r and omly divided into five groups of six animals each : control , GM ( 100 mg/kg/day ) , ATO ( 10 mg/kg/day ) , GM + ATO , and GM + Vehicle . Kidney function tests , tissue oxidative stress parameters , and histopathological and immunohistochemical studies clarified GM nephrotoxicity . Results . GM caused a marked reduction in renal functions and increased oxidative stress parameters . Histopathological examination revealed tubular necrosis especially in the renal cortex in GM rats . On immunohistochemical evaluation , GM rat showed more intense expressions of mitogen-activated protein kinase ( MAPK ) , nuclear factor kappa B ( NF‐kB ) , and inducible nitric oxide synthase ( iNOS ) compared with control . Kidney function tests and tissue oxidative stress parameters were normalized in the GM + ATO group . Histopathological and immunohistochemical pictures were also greatly ameliorated . Conclusions . ATO acts in the kidney as a potent scavenger of free radicals to prevent the toxic effects of GM via the inhibition of MAPK and NF-kB signaling pathways and iNOS expression A decline in kidney function after contrast exposure is associated with a high risk of morbidity and mortality during hospitalization and over long-term periods . Several retrospective and recent prospect i ve clinical trials have shown that statin therapy might prevent contrast-induced nephropathy in patients undergoing percutaneous coronary intervention . In this study , we aim ed to assess the effects of statin therapies on renal function parameters in patients undergoing elective coronary angiography . One hundred and sixty patients undergoing elective coronary angiography were r and omized equally into two groups : atorvastatin 40 mg/day group ( statin started 3 days before coronary angiography ) and an untreated control group . An additional 80 patients were included as a chronic statin therapy group . Serum creatinine , serum cystatin C , and glomerular filtration rate ( GFR ) were measured before and 48 h after coronary angiography . Cockcroft – Gault and Modification of Diet in Renal Disease ( MDRD ) equations were used to determine GFR . After coronary angiography , serum creatinine and GFR determined by MDRD were significantly better in patients using atorvastatin than those in controls ( P = 0.002 and P = 0.004 , respectively ) . Postprocedure serum creatinine , cystatin C , and GFR determined by MDRD were also significantly better in chronic statin therapy group than those in controls ( P = 0.006 , P = 0.003 , and P = 0.004 , respectively ) . There were no differences in renal function parameters between the short-term atorvastatin group and the chronic statin therapy group . Our data demonstrate that the use of short-term atorvastatin and chronic statin therapy may have a role in protecting renal function after elective coronary angiography Contrast-induced nephropathy ( CIN ) impairs clinical outcome in patients undergoing angiographic procedures . The aim of this study was to investigate whether short-term high-dose atorvastatin load decreases the incidence of CIN after percutaneous coronary intervention ( PCI ) . Statin-naive patients with acute coronary syndrome undergoing PCI ( n = 241 ) r and omly received atorvastatin ( 80 mg 12 hours before intervention with another 40-mg preprocedure dose , n = 120 ) or placebo ( n = 121 ) . All patients had long-term atorvastatin treatment thereafter ( 40 mg/day ) . Primary end point was incidence of CIN defined as postintervention increase in serum creatinine ≥0.5 mg/dl or > 25 % from baseline . Five percent of patients in the atorvastatin arm developed CIN versus 13.2 % of those in the placebo arm ( p = 0.046 ) . In the atorvastatin group , postprocedure serum creatinine was significantly lower ( 1.06 ± 0.35 vs 1.12 ± 0.27 mg/dl in placebo , p = 0.01 ) , creatinine clearance was decreased ( 80.1 ± 32.2 vs 72.0 ± 26.6 ml/min , p = 0.034 ) , and C-reactive protein peak levels after intervention were decreased ( 8.4 ± 10.5 vs 13.1 ± 20.8 mg/l , p = 0.01 ) . Multivariable analysis showed that atorvastatin pretreatment was independently associated with a decreased risk of CIN ( odds ratios 0.34 , 95 % confidence interval 0.12 to 0.97 , p = 0.0
Output:
| This review concluded that chronic statin user may be less prone to contrast-induced nephropathy ( CIN ) compared with statin non-users .
Short-term high dose statin administration may also reduce the incidence of CIN in statin naïve patients .
This renoprotective effect of statins against CIN is seen in low risk patients with normal kidney function or mild kidney dysfunction , but probably not in patients with moderate to severe renal dysfunction . |
MS213291 | ***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 efficacy and side-effect profile of ulipristal acetate as compared with those of leuprolide acetate for the treatment of symptomatic uterine fibroids before surgery are unclear . METHODS In this double-blind noninferiority trial , we r and omly assigned 307 patients with symptomatic fibroids and excessive uterine bleeding to receive 3 months of daily therapy with oral ulipristal acetate ( at a dose of either 5 mg or 10 mg ) or once-monthly intramuscular injections of leuprolide acetate ( at a dose of 3.75 mg ) . The primary outcome was the proportion of patients with controlled bleeding at week 13 , with a prespecified noninferiority margin of -20 % . RESULTS Uterine bleeding was controlled in 90 % of patients receiving 5 mg of ulipristal acetate , in 98 % of those receiving 10 mg of ulipristal acetate , and in 89 % of those receiving leuprolide acetate , for differences ( as compared with leuprolide acetate ) of 1.2 percentage points ( 95 % confidence interval [ CI ] , -9.3 to 11.8 ) for 5 mg of ulipristal acetate and 8.8 percentage points ( 95 % CI , 0.4 to 18.3 ) for 10 mg of ulipristal acetate . Median times to amenorrhea were 7 days for patients receiving 5 mg of ulipristal acetate , 5 days for those receiving 10 mg of ulipristal acetate , and 21 days for those receiving leuprolide acetate . Moderate-to-severe hot flashes were reported for 11 % of patients receiving 5 mg of ulipristal acetate , for 10 % of those receiving 10 mg of ulipristal acetate , and for 40 % of those receiving leuprolide acetate ( P<0.001 for each dose of ulipristal acetate vs. leuprolide acetate ) . CONCLUSIONS Both the 5-mg and 10-mg daily doses of ulipristal acetate were noninferior to once-monthly leuprolide acetate in controlling uterine bleeding and were significantly less likely to cause hot flashes . ( Funded by PregLem ; Clinical Trials.gov number , NCT00740831 . ) OBJECTIVE To investigate the effect of 2 medications ; Diphereline and Cabergoline , on uterine leiomyoma growth , and its histologic , sonographic , and intra-operative changes . METHODS In an effort to treat large uterine leiomyoma in symptomatic patients in the Gynecology Clinics of the Alzahra Teaching Hospital of Tabriz University of Medical Sciences , Tabriz , Iran , from September 2007 to November 2008 , 60 c and i date s r and omized to receive Diphereline 3.75 mg , 4 times every 28 days ( group I ) , and Cabergoline 0.5 mg , once a week for 6 weeks ( group II ) , were included in this study . Clinical symptoms , feasibility of intra-operative dissection , intraoperative complications , sonographic , and pathologic characteristics of the tumor were evaluated . RESULTS Thirteen patients from group I , and 10 patients from group II underwent surgery . There was a significant difference between the groups in the rate of lymphocyte infiltration ( p=0.003 ) , but not in other pathologic features . In both groups , the mitotic index was between 0 - 10 . While there was no significant difference between the groups in the number ( p=0.30 ) , and volume of leiomyomas ( p=0.65 ) , however , changes in the uterine artery circulation was significant ( p=0.001 [ group I ] , p=0.026 [ group II ] ) . In addition , there was a significant difference between the groups for intra-operative hemorrhage and adhesion of leiomyomas to the uterine wall . CONCLUSION This study found that Cabergoline is as effective as Diphereline in the shrinkage of myomas , accompanied by improvement in the sonographic , clinical , and intra-operative outcomes without any adverse pathological changes , and could be a good medical regimen as an adjunct to surgical management Fifty premenopausal patients requiring hysterectomy as treatment for symptomatic uterine leiomyomas , which were the size of 14 to 18 weeks ' gestation , were r and omized into two groups to determine whether preoperative gonadotropin-releasing hormone agonist would increase the feasibility of vaginal rather than abdominal hysterectomy . The control group ( group A ; n = 25 ) did not receive preoperative gonadotropin-releasing hormone agonist , but patients in Group B ( n = 25 ) received 2 months of gonadotropin-releasing hormone agonist before undergoing hysterectomy . Patients in the two groups were similar with respect to age , gravidity , parity , pretreatment uterine size , and hemoglobin and hematocrit levels . Patients in group B had an increase in hemoglobin levels ( 10.75 to 12.12 gm/dl , p less than 0.05 ) and a decrease in uterine volume ( 1086.7 to 723.4 ml , p less than 0.05 ) after 8 weeks of agonist therapy and were more likely to undergo vaginal hysterectomy ( 76.0 % vs 16 % ) . Patients in group B also had shorter hospitalizations ( 5.2 vs 3.8 days , p less than 0.05 ) . We conclude that the administration of gonadotropin-releasing hormone agonist for 2 months followed by vaginal hysterectomy is preferable to abdominal hysterectomy in selected patients with uterine leiomyomas A. J. M. AUDEBERT , P. MADENELAT * , D. Q U E R L E U ? , G. P O N T O N N I E R ~ , C . R A C I N E T ~ , R.R E N A U D ~ , J.-Y. GILLET * * , D. R A U D R A N T ? ~ , J. LANSAC:~ , J.-P. B R E T T E ~ Cnbitiet Medical . Bordeaus : * Hdpital Bichat , Paris ; ? Centre Hospitalier , Roubai.r ; 1 Hdpital de la Grave , Toulouse ; $ Centre Hospiialier Sud , Ecliirolles : Hfipital Central , Strasbourg ; * * Hi?pital Saint Roch , Nice ; ttH6pital de I'Hdtel Dieu , Lyon ; : $ Hdpital de Tours , Tours ; and # Hipito1 Monwti . Brest . OBJECTIVE Our purpose was to examine the effects of RU 486 and leuprolide acetate on uterine artery blood flow and uterine volume . STUDY DESIGN Patients were r and omly assigned to group A ( eight patients ) receiving 25 mg of RU 486 daily for 3 months or group B ( six patients ) receiving 3.75 mg of leuprolide acetate monthly for 3 months . Uterine artery blood flow change was determined by resistive index by means of vaginal color Doppler ultrasonography . Uterine volume was measured before and during the study with abdominal ultrasonography . RESULTS Both groups showed an increase in resistive index . Patients receiving RU 486 had uterine artery blood flow decreased by 40 % , and those receiving leuprolide acetate had a 21 % decrease . We noted a significant decrease in uterine volume compared with pretreatment in both groups at 3 months . There was no significant decrease between groups . CONCLUSION Both RU 486 ( 25 mg daily ) and leuprolide acetate ( 3.75 mg monthly ) are effective in decreasing blood flow to the uterus ( increasing resistive index ) and decreasing uterine volume at 3 months . A significant decrease in uterine artery blood flow may provide a mechanism for the decrease in uterine size and the decrease in uterine blood loss at the time of surgery Background Fibroma , the most common benign pelvic tumor in women , affects 25 to 30 % of women of reproductive age . Primary treatment for patients with symptomatic or large fibroma is surgery . Objective The purpose of this study was to investigate the effect of a single rectal dose of Misoprostol on bleeding during abdominal hysterectomy . Methods This double blind r and omized clinical trial was conducted with 80 c and i date s for abdominal hysterectomy , due to uterine myoma , in the Shahid Sadoughi hospital of Yazd in 2012 . The aim of this study was to assess the effect of single rectal dose of Misoprostol on peri-operational abdominal hysterectomy bleeding . Following administration of 400 micrograms of Misoprostol in the case group ( n=40 ) , predetermined criteria were compared with control group ( n=40 ) . Results Volume of bleeding during the operation was significantly lower in cases where Misoprostol was used . ( 268.71 ± 156.85 vs. 350.38 ± 152.61 cc in the case and control groups , respectively ) . Our findings also showed that Hemoglobin ( Hb ) levels before , 8 , and 30 hours following the operation differed significantly ( p=0.001 ) , but these changes were similar in both groups . Pre-operative Hb levels were 11.90 ± 1.7 and 11.90 ± 2.0 in the case and control groups , respectively . Conclusion A single rectal dose of Misoprostol has positive effect on reducing peri-operational bleeding in women undergoing abdominal hysterectomy due to symptomatic leiomyoma Summary . Twenty‐four women with symptomatic multiple uterine myomas were allocated r and omly to treatment with buserelin , 1200μg/day intranasally , for 3 months followed by myomectomy ( n = 8) or to immediate myomectomy ( n = 16 ) . Pre‐operative treatment with buserelin reduced the mean uterine volume from 432 ( SD 165 ) to 242 ( SD 82 ) ml ( P < 0.01 ) but intra‐operative blood loss and postoperative morbidity were not significantly less in this group . Six months after operation , pelvic examination was normal in all the patients . However , ultrasonography with transvaginal probe demonstrated the presence of myomas of < 1.5 cm in five women ( 63 % ) treated pre‐operatively with the analogue and in two women ( 13 % ) who underwent immediate surgery ( P < 0.05 ) . Induction of a period of hypo‐oestrogenism before myomectomy seems to favour short‐term recurrence of uterine myomas , limiting the efficacy of surgery STUDY OBJECTIVE To evaluate whether tibolone modifies the effectiveness of gonadotropin-releasing hormone ( GnRH ) analog administered before laparoscopic myomectomy . DESIGN Prospect i ve , r and omized , open , placebo-controlled clinical trial ( Canadian Task Force classification I ) . SETTING University-affiliated hospital . PATIENTS Sixty-six women with symptomatic leiomyomas . INTERVENTIONS Patients received 2 months of treatment with GnRH analog and iron plus tibolone ( group A ) or placebo ( group B ) ; group C received only iron . Laparoscopic myomectomy was performed after medical treatment . MEASUREMENTS AND MAIN RESULTS Uterine volume , number and volume of leiomyomas , echogenicity and volume of the largest leiomyomas , hematologic values , and myoma-related symptoms were evaluated at baseline , 1 week before , and 1 week after surgery . We observed significant ( p < 0.05 ) reductions in uterine and leiomyomata volume , myoma-related symptoms , and improvement in hematologic values before surgery in groups A and B , without significant difference between groups compared with baseline values and group C. Operating time and blood loss were significantly ( p < 0.05 ) lower in groups A and B , without significant difference compared with group C. After surgery , significant numbers of women in group C had worsening of hematologic values ( p < 0.05 ) . CONCLUSION Adding tibolone to the GnRH analog regimen before laparoscopic myomectomy does not modify the effectiveness of GnRH analog administered alone BACKGROUND Vaginal hysterectomy is considered the method of choice for removal of the uterus but most gynecologists still prefer the abdominal route for removal of benign uteri > 14 weeks in size . Conversion of an abdominal to a potential vaginal hysterectomy by uterine size reduction would be advantageous . Gonadotrophin-releasing hormone ( GnRH ) agonists can reduce uterine bulk by up to 50 % . OBJECTIVE To evaluate the efficacy of the preoperative administration of a GnRH agonist for women with enlarged non-prolapsing uteri in order to facilitate vaginal hysterectomy , in comparison with patients with enlarged uteri who underwent direct total abdominal hysterectomy ( TAH ) for the same indication ( menorrhagia ) . STUDY DESIGN R and omized controlled study . Women scheduled for hysterectomy for menorrh
Output:
| There was no evidence of differences in preoperative complications .
There is clear evidence that preoperative GnRHa reduces uterine and fibroid volume , and increases preoperative haemoglobin levels , although GnRHa increases the incidence of hot flushes .
During hysterectomy , blood loss , operation time and complication rates were also reduced . |
MS213292 | ***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 aim of this study was to evaluate the internal fit , marginal adaptation , and bond strengths of inlays made of computer-aided design /computer-aided manufacturing feldspathic ceramic and polymer-infiltrated ceramic . Twenty molars were r and omly selected and prepared to receive inlays that were milled from both material s. Before cementation , internal fit was achieved using the replica technique by molding the internal surface with addition silicone and measuring the cement thicknesses of the pulpal and axial walls . Marginal adaptation was measured on the occlusal and proximal margins of the replica . The inlays were then cemented using resin cement ( Panavia F2.0 ) and subjected to two million thermomechanical cycles in water ( 200 N load and 3.8-Hz frequency ) . The restored teeth were then cut into beams , using a lathe , for microtensile testing . The contact angles , marginal integrity , and surface patterns after etching were also observed . Statistical analysis was performed using two-way repeated measures analysis of variance ( p<0.05 ) , the Tukey test for internal fit and marginal adaptation , and the Student t-test for bond strength . The failure types ( adhesive or cohesive ) were classified on each fractured beam . The results showed that the misfit of the pulpal walls ( p=0.0002 ) and the marginal adaptation ( p=0.0001 ) of the feldspathic ceramic were significantly higher when compared to those of the polymer-infiltrated ceramic , while the bond strength values of the former were higher when compared to those of the latter . The contact angle of the polymer-infiltrated ceramic was also higher . In the present study , the hybrid ceramic presented improved internal and marginal adaptation , but the bond strengths were higher for the feldspathic ceramic Objectives This study was conducted to evaluate a self-adhesive resin luting cement [ RelyX Unicem 3MESPE – RXU ] for luting partial ceramic crowns ( PCCs ) with and without selective enamel etching in a prospect i ve , r and omized clinical trial . Material s and methods Thirty-four patients had received the intended treatment . Two PCCs ( Vita Mark II ; Cerec 3D ; Sirona ) had been placed in a split-mouth design : one with RXU without enamel etching ( RXU ) , the other with RXU with selective enamel etching ( RXU + E ) . Restorations were evaluated at baseline ( BL ) and after 12 , 24 , and 36 months ( USPHS criteria ) . For statistical analysis , the Chi-square test was applied ( α = 0.05 ) . Clinical survival of all restorations ( n = 68 ) after 3 years was determined using Kaplan – Meier analysis . Results Twenty three patients ( 12 male/11 female ) were available for clinical evaluation after 3 years . 19 RXU-PCCs were placed in molars , four in premolars , 18 RXU + E – PCCs in molars , five in premolars . Concerning clinical changes , no significant differences were found between luting strategies RXU/RXU + E at all recalls . Statistically significant changes over time were observed for marginal adaptation and marginal discoloration between BL and 36 m for RXU and RXU + E. For RXU + E , postoperative hypersensitivities decreased significantly from BL ( n = 6 ) to 36 m ( n = 0 ) . Of the 68 restorations originally included , eight RXU and four RXU + E restorations failed . At 3 years , Kaplan – Meier survival of RXU was 72.9 % , that of RXU + E 87.6 % . Survival rates were not statistically significant different . Conclusions Although clinical survival of RXU + E is slightly better at 3 years , restorations of both groups perform similar with respect to clinical changes over time as evaluated by modified USPHS criteria . Clinical relevance The self-adhesive resin cement RXU can be used in conjunction with selective enamel etching , because survival rates of PCCs in the RXU + E group were not lower but , as a trend , even better than without enamel etching Statement of problem Trials comparing the overall performance of digital with that of conventional workflows in restorative dentistry are needed . Purpose The purpose of the third part of a series of investigations was to test whether the marginal and internal fit of monolithic crowns fabricated with fully digital workflows differed from that of crowns fabricated with the conventional workflow . Material and methods In each of 10 participants , 5 monolithic lithium disilicate crowns were fabricated for the same abutment tooth according to a r and omly generated sequence . Digital workflows were applied for the fabrication of 4 crowns using the Lava , iTero , Cerec inLab , and Cerec infinident systems . The conventional workflow included a polyvinyl siloxane impression , manual waxing , and heat‐press technique . The discrepancy between the crown and the tooth was registered using the replica technique with polyvinyl siloxane material . The dimensions of the marginal discrepancy ( Discrepancymarginal ) and the internal discrepancy in 4 different regions of interest ( Discrepancyshoulder , Discrepancyaxial , Discrepancycusp , and Discrepancyocclusal ) were assessed using light microscopy . Post hoc Student t test with Bonferroni correction was applied to detect differences ( & agr;=.05 ) . Results Discrepancymarginal was 83.6 ±51.1 & mgr;m for the Cerec infinident , 90.4 ±66.1 & mgr;m for the conventional , 94.3 ±58.3 & mgr;m for the Lava , 127.8 ±58.3 & mgr;m for the iTero , and 141.5 ±106.2 & mgr;m for the Cerec inLab workflow . The differences between the treatment modalities were not statistically significant ( P>.05 ) . Discrepancyshoulder was 82.2 ±42.4 & mgr;m for the Cerec infinident , 97.2 ±63.8 & mgr;m for the conventional , 103.4 ±52.0 & mgr;m for the Lava , 133.5 ±73.0 & mgr;m for the iTero , and 140.0 ±86.6 & mgr;m for the Cerec inLab workflow . Only the differences between the Cerec infinident and the Cerec inLab were statistically significant ( P=.036 ) . The conventionally fabricated crowns revealed significantly lower values in Discrepancycusp and Discrepancyocclusal than all the crowns fabricated with digital workflows ( P<.05 ) . Conclusions In terms of marginal crown fit , no significant differences were found between the conventional and digital workflows for the fabrication of monolithic lithium disilicate crowns . In the occlusal regions , the conventionally manufactured crowns revealed better fit than the digitally fabricated crowns . Chairside milling result ed in less favorable crown fit than central ized milling production Background Evaluation of the marginal fit of cemented zirconia copings manufactured after digital impression with Lava ™ Chairside Oral Scanner in comparison to that of zirconia copings manufactured after conventional impressions with polyvinyl siloxane . Methods A prepared typodont tooth # 36 , was replicated 40 times with a vinyl silicone and precise model resin . The dies were r and omly divided into two groups according to the impression taking technique . Digital impressions with Lava ™ C.O.S. and conventional impressions were taken according to the group . Subsequently zirconia copings were manufactured and cemented on their respective dies with zinc oxide phosphate cement . After embedding in resin , mesio-distal section of each coping was performed with a diamond saw in order to obtain two slices . One half of the specimen was used for evaluation with an optical microscope ( OM ) and the other half for evaluation with a scanning electron microscope ( SEM ) . Marginal gap ( MG ) and absolute marginal discrepancy ( AMD ) were measured mesial and distal on each slice . Results No significant difference of the marginal parameters between the digital and the conventional group was found . The mean values for MG in the digital group were 96.28 μm ( + /−43.21 μm ) measured with the OM and 99.26 μm ( + /−48.73 μm ) measured with the SEM , respectively . AMD mean values were 191.54 μm ( + /−85.42 μm ) measured with the optical microscope and 211.6 μm ( + /−96.55 μm ) with the SEM . For the conventional group the mean MG values were 94.84 μm ( + /−50.77 μm ) measured with the OM and 83.37 μm ( + /−44.38 μm ) measured with the SEM , respectively . AMD mean values were 158.60 μm ( + /−69.14 μm ) for the OM and 152.72 μm ( + /−72.36 ) for the SEM . Conclusions Copings manufactured after digital impression with Lava ™ C.O.S. show comparable marginal parameters with the copings manufactured after conventional impression with polyvinyl syloxane . The mean MG values of both groups fit in the clinical ly acceptable range OBJECTIVES The aim of the study was to evaluate the marginal and internal fit of heat-pressed and CAD/CAM fabricated all-ceramic onlays before and after luting as well as after thermo-mechanical fatigue . MATERIAL S AND METHODS Seventy-two caries-free , extracted human m and ibular molars were r and omly divided into three groups ( n=24/group ) . All teeth received an onlay preparation with a mesio-occlusal-distal inlay cavity and an occlusal reduction of all cusps . Teeth were restored with heat-pressed IPS-e.max-Press * ( IP , * Ivoclar-Vivadent ) and Vita-PM9 ( VP , Vita-Zahnfabrik ) as well as CAD/CAM fabricated IPS-e.max-CAD * ( IC , Cerec 3D/InLab/Sirona ) all-ceramic material s. After cementation with a dual-polymerising resin cement ( VariolinkII * ) , all restorations were subjected to mouth-motion fatigue ( 98 N , 1.2 million cycles ; 5 ° C/55 ° C ) . Marginal fit discrepancies were examined on epoxy replicas before and after luting as well as after fatigue at 200 × magnification . Internal fit was evaluated by multiple sectioning technique . For the statistical analysis , a linear model was fitted with accounting for repeated measurements . RESULTS Adhesive cementation of onlays result ed in significantly increased marginal gap values in all groups , whereas thermo-mechanical fatigue had no effect . Marginal gap values of all test groups were equal after fatigue exposure . Internal discrepancies of CAD/CAM fabricated restorations were significantly higher than both press manufactured onlays . CONCLUSIONS Mean marginal gap values of the investigated onlays before and after luting as well as after fatigue were within the clinical ly acceptable range . Marginal fit was not affected by the investigated heat-press versus CAD/CAM fabrication technique . Press fabrication result ed in a superior internal fit of onlays as compared to the CAD/CAM technique . CLINICAL RELEVANCE Clinical requirements of 100 μm for marginal fit were fulfilled by the heat-press as well as by the CAD/CAM fabricated all-ceramic onlays . Superior internal fit was observed with the heat-press manufacturing method . The impact of present findings on the clinical long-term behaviour of differently fabricated all-ceramic onlays warrants further investigation STATEMENT OF PROBLEM Gap measurements along margins are frequently used to assess the quality of single crowns . However , the number of gap measurements required for clinical ly relevant results in laboratory studies is not known . PURPOSE This study estimated the minimum number of gap measurements on margins of single crowns to produce relevant results for gap analysis . METHODS AND MATERIAL Ten all-ceramic crowns were fabricated on a master steel die . Gaps along crown margins were investigated in a scanning electron microscope on the master steel die without cementation and on replica dies after conventional cementation . Measurements were made in 100 microm steps according to 3 gap definitions . The initial number of measurements per crown ( n = 230 ) was reduced to smaller subsets using both systematic and r and om approaches to determine the impact on the quality of results . RESULTS On the data of gap definition 1 , reduction from 230 to about 50 measurements caused less than + /-5 microm variability for arithmetic means . Analysis of st and ard errors showed slowly increasing values smaller than 3 microm , both indicating no relevant impact on the quality of results . Smaller data sizes yielded accelerated increase of st and ard errors and divergent variabilities of mean . The minimum of 50 measurements did not depend on gap definition or on cementation condition . CONCLUSION Fifty measurements are required for clinical ly relevant information about gap size regardless of whether the measurement sites are selected in a systematic or r and om manner , which is far more than what current in vitro studies use Objective This study examined the fit of two types of all-ceramic single crowns and indirect composite resin full coverage crowns . Material and Methods Thirty intact human m and ibular first premolars were selected for this study and prepared using a machine to st and ardize the dimensions and r and omly divided into 3 groups . Slip cast ( IC ) ( In-Ceram Zircon
Output:
| Conclusions Most of the studies reported clinical ly acceptable values for marginal adaptation .
The performance of a CAD‐CAM system is influenced by the type of restorative material .
A nonretentive cavity preparation exhibited better adaptation than a retentive preparation .
Most studies showed that thermomechanical loading affected the quality of marginal adaptation .
Cementation increased marginal discrepancies .
No statistically significant difference was found for marginal fit of onlays between intraoral and extraoral optical scans using a stone die .
The number of milling axes , the type of digital camera , and the region measured were statistically significant in relation to marginal/internal adaptation .
Values of adaptation recorded failed to reproduce the preestablished spacer parameters in the software . |
MS213293 | ***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: There is limited evidence on the association between adherence to guidelines for cancer survivors and health-related quality of life ( HRQoL ) . In a cross-sectional study of Korean breast cancer survivors , we examined whether adherence to the guidelines of the American Cancer Society ( ACS ) and World Cancer Research Fund/American Institute for Cancer Research ( WCRF/AICR ) for cancer survivors was related to levels of HRQoL , assessed by the Korean version of Core 30 ( C30 ) and Breast cancer module 23 ( BR23 ) of the European Organization for Research and Treatment of Cancer- Quality of Life Question naire ( EORTC-QLQ ) . We included a total of 160 women aged 21 to 79 years who had been diagnosed with breast cancer according to American Joint Committee on Cancer ( AJCC ) stages I to III and had breast cancer surgery at least six months before the interview . Increasing adherence to ACS guidelines was associated with higher scores of social functioning ( p for trend = 0.05 ) , whereas increasing adherence to WCRF/AICR recommendations was associated with higher scores of arm symptoms ( p for trend = 0.01 ) . These associations were limited to those with stage II or III cancer . Diet may be an important factor in relation to quality of life among Korean breast cancer survivors , however our findings warrant further prospect i ve studies to evaluate whether healthy diet improves survivors ’ quality of life Background The relationship between colorectal cancer ( CRC ) risk and physical activity and dietary habits has been well-established , but less is known about the relationship between these behaviours and quality of life ( QOL ) post-diagnosis . Moreover , it is unknown whether this relationship is consistent across cancer stage or treatment setting . Thus , the purpose of this study was to assess current diet and physical activity behaviour in CRC survivors receiving systemic chemotherapy , and to examine potential associations between these behaviours and quality of life . A secondary purpose was to examine the association between social support , diet , and physical activity behaviour in this population . Methods Using a cross-sectional survey , 67 CRC survivors currently receiving chemotherapy in Calgary , Alberta completed the survey package . Measures included demographic and medical data , physical activity levels , diet behaviour , QOL , and social support . Results In a largely metastatic sample ( 63 % ) , approximately half were meeting national dietary guidelines ( 58 % ) , less were meeting national physical activity guidelines ( 26 % ) , and a small number were meeting both ( 17 % ) . However , only 12.3 % ( n = 8) reported completely sedentary behaviour , and 7 of these 8 participants were receiving metastatic treatment . Neither behaviour was significantly associated with QOL or perceived social support . Furthermore , there were no significant QOL differences between those treated with palliative intent or adjuvant therapy . Important group differences emerged between those meeting and not meeting the guidelines , and associations between QOL , age , BMI , and provisions of social support . Conclusion These findings provide insight into lifestyle behaviours of CRC survivors currently receiving systemic chemotherapy , and the differences in perceived QOL as affected by severity of disease and treatment setting . Prospect i ve studies in a larger sample of CRC survivors on chemotherapy are needed to confirm lifestyle behaviour patterns and identify factors related to QOL that are unique to this population , especially during metastatic treatment PURPOSE Single-variable analyses have associated physical activity , diet , and obesity with survival after breast cancer . This report investigates interactions among these variables . PATIENTS AND METHODS A prospect i ve study was performed of 1,490 women diagnosed and treated for early-stage breast cancer between 1991 and 2000 . Enrollment was an average of 2 years postdiagnosis . Only seven women were lost to follow-up through December 2005 . RESULTS In univariate analysis , reduced mortality was weakly associated with higher vegetable-fruit consumption , increased physical activity , and a body mass index that was neither low weight nor obese . In a multivariate Cox model , only the combination of consuming five or more daily servings of vegetables-fruits , and accumulating 540 + metabolic equivalent tasks-min/wk ( equivalent to walking 30 minutes 6 d/wk ) , was associated with a significant survival advantage ( hazard ratio , 0.56 ; 95 % CI , 0.31 to 0.98 ) . The approximate 50 % reduction in risk associated with these healthy lifestyle behaviors was observed in both obese and nonobese women , although fewer obese women were physically active with a healthy dietary pattern ( 16 % v 30 % ) . Among those who adhered to this healthy lifestyle , there was no apparent effect of obesity on survival . The effect was stronger in women who had hormone receptor-positive cancers . CONCLUSION A minority of breast cancer survivors follow a healthy lifestyle that includes both recommended intakes of vegetables-fruits and moderate levels of physical activity . The strong protective effect observed suggests a need for additional investigation of the effect of the combined influence of diet and physical activity on breast cancer survival Objective With increases in cancer survival , promotion of healthy lifestyle behaviors among survivors is receiving considerable attention . This study compared health behaviors among a large sample of Australian adult cancer survivors with an age- and sex-matched cohort of people with no cancer history . Methods Using the Australian National Health Survey , 968 cancer survivors were identified , and r and omly matched by age and sex to 5,808 respondents without a history of cancer . Six health behaviors were compared ( smoking , physical activity , servings of vegetables , servings of fruit , alcohol use , skin checks ) , along with overweight and obesity , using polytomous logistic regression analyses controlling for selected chronic conditions . Models were applied across both groups and by tumor site . Results Compared to the non-cancer comparison group , cancer survivors were significantly more likely to be current ( OR = 1.35 ) smokers , particularly those under 40 years ( OR = 1.69 ) , and more likely to have regular skin checks ( OR = 1.76 ) . Although not significant , there was consistent evidence that cancer survivors were slightly more likely to be overweight or obese ( p = 0.065 ) and have higher levels of alcohol consumption ( p = 0.088 ) . There was no evidence of differences between survivors and controls for levels of physical inactivity , vegetable consumption or fruit consumption . Women with a history of gynecological cancers were much more likely to be current smokers ( OR = 2.37 ) , while other differences by sex and cancer site were consistent with overall patterns . Cancer survivors were also significantly more likely to report having a range of co-morbid chronic medical conditions . Conclusion Given their increased risk of second cancers and co-morbid chronic conditions , the lack of difference in behavioral risk factors confirms the need for a focus on improving the health behaviors of cancer survivors . Collaborative chronic disease management models may be particularly appropriate in this regard AIMS To assess self-reported lifetime prevalence of cardiovascular disease ( CVD ) among colorectal cancer survivors , and examine the cross-sectional and prospect i ve associations of lifestyle factors with co-morbid CVD . METHODS Colorectal cancer survivors were recruited ( n=1966 ) . Data were collected at approximately 5 , 12 , 24 and 36 months post-diagnosis . Cross-sectional findings included six CVD categories ( hypercholesterolaemia , hypertension , diabetes , heart failure , kidney disease and ischaemic heart disease ( IHD ) ) at 5 months post-diagnosis . Longitudinal outcomes included the probability of developing ( de novo ) co-morbid CVD by 36 months post-diagnosis . Lifestyle factors included body mass index , physical activity , television ( TV ) viewing , alcohol consumption and smoking . RESULTS Co-morbid CVD prevalence at 5 months post-diagnosis was 59 % , and 16 % of participants with no known CVD at the baseline reported de novo CVD by 36 months . Obesity at the baseline predicted de novo hypertension ( odds ratio [OR]=2.20 , 95 % confidence intervals [CI]=1.09 , 4.45 ) and de novo diabetes ( OR=6.55 , 95 % CI=2.19 , 19.53 ) . Participants watching > 4h of TV/d at the baseline ( compared with < 2h/d ) were more likely to develop ischaemic heart disease by 36 months ( OR=5.51 , 95 % CI=1.86 , 16.34 ) . CONCLUSION Overweight colorectal cancer survivors were more likely to suffer from co-morbid CVD . Interventions focusing on weight management and other modifiable lifestyle factors may reduce functional decline and improve survival PURPOSE Colorectal cancer survivors are at risk for poor health outcomes because of unhealthy lifestyles , but few studies have developed translatable health behavior change interventions . This study aim ed to determine the effects of a telephone-delivered multiple health behavior change intervention ( CanChange ) on health and behavioral outcomes among colorectal cancer survivors . METHODS In this two-group r and omized controlled trial , 410 colorectal cancer survivors were r and omly assigned to the health coaching intervention ( 11 theory-based telephone-delivered health coaching sessions delivered over 6 months focusing on physical activity , weight management , dietary habits , alcohol , and smoking ) or usual care . Assessment of primary ( ie , physical activity [ Godin Leisure Time Index ] , health-related quality of life [ HRQoL ; Short Form-36 ] , and cancer-related fatigue [ Functional Assessment of Chronic Illness Therapy Fatigue Scale ] ) and secondary outcomes ( ie , body mass index [ kg/m(2 ) ] , diet and alcohol intake [ Food Frequency Question naire ] , and smoking ) were conducted at baseline and 6 and 12 months . RESULTS At 12 months , significant intervention effects were observed for moderate physical activity ( 28.5 minutes ; P = .003 ) , body mass index ( -0.9 kg/m(2 ) ; P = .001 ) , energy from total fat ( -7.0 % ; P = .006 ) , and energy from saturated fat ( -2.8 % ; P = .016 ) . A significant intervention effect was reported for vegetable intake ( 0.4 servings per day ; P = .001 ) at 6 months . No significant group differences were found at 6 or 12 months for HRQoL , cancer-related fatigue , fruit , fiber , or alcohol intake , or smoking . CONCLUSION The CanChange intervention was effective for improving physical activity , dietary habits , and body mass index in colorectal cancer survivors . The intervention is translatable through existing telephone cancer support and information services in Australia and other countries Purpose Differences in health status and behavioral risk factors may explain racial/ethnic breast cancer disparities . We examined racial/ethnic differences in health status and behaviors among female breast cancer survivors compared to females without breast cancer . Methods Using cross-sectional data from the 2009 Behavioral Risk Factor Surveillance System , a national state-based , r and om sample telephone survey , we explored differences in self-rated health , obesity and selected behaviors ( physical activity , smoking , alcohol use , fruit , and vegetable consumption ) among females aged 18 years and older , who reported a previous breast cancer diagnosis ( survivors , n = 10,035 ) and those who reported no breast cancer history ( n = 234,375 ) by race/ethnicity . Adjusted prevalences of health status and behaviors , accounting for sociodemographics , comorbidities and health care access , were estimated by race/ethnicity . Results Compared to all other racial/ethnic groups , more white females reported heavy alcohol consumption and more black females reported obesity regardless of their breast cancer status . Among breast cancer survivors , more whites ( 33.7 % ) were former smokers compared to blacks ( 24.5 % ) , “ others ” ( 20.5 % ) , and Hispanics ( 16.2 % ) ( p = 0.001 ) . Racial/ethnic differences in obesity also varied by reported time since diagnosis ( p value = 0.018 ) . Among long-term survivors ( diagnosed > 5 years before interview ) , more black survivors ( 34.8 % ) reported obesity compared to white survivors ( 23.0 % ) . Also , among “ other ” race survivors , long-term survivors ( 22.0 % ) reported more obesity than survivors diagnosed less than 5 years before interview ( 7.8 % ) . Conclusions These findings suggest opportunities to increase health behaviors and reduce racial disparities among breast cancer survivors . Implication s for Cancer SurvivorsEngaging in healthy behaviors can play a significant role in enhancing health outcomes and quality of life of breast cancer survivors . More research is needed to better underst and racial differences in obesity , smoking and alcohol consumption in order to develop effective , culturally appropriate interventions to promote a healthy lifestyle after a breast cancer diagnosis Purpose The effectiveness of survivorship care plans has not been widely tested . We evaluated whether a one-time brief lifestyle consultation as part of a broader survivorship care plan was effective at changing diet and lifestyle patterns . Methods A diverse sample of women with stage 0-III breast cancer were r and omized to control or intervention groups within 6 weeks of completing adjuvant treatment . Both groups received the National Cancer Institute publication , “ Facing Forward : Life after Cancer Treatment . ” The intervention group also met with a nurse ( 1 h ) and a nutritionist ( 1 h ) to receive personalized lifestyle recommendations based
Output:
| Conclusion Adherence to physical activity , dietary , and multiple lifestyle behaviours recommendations was low amongst cancer survivors .
Recent cancer survivors were relatively more adherent to WCRF/AICR recommendations compared to long-term survivors .
Implication s for Cancer SurvivorsHealth promotion programs help support healthy lifestyle behaviours of cancer survivors . |
MS213294 | ***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 AND PURPOSE The purpose of this study was to prospect ively evaluate a protocol with hypertonic saline hydroxyethyl starch ( HS-HES ) and mannitol in stroke patients with increased intracranial pressure ( ICP ) . METHODS We studied 30 episodes of ICP crisis in 9 patients . ICP crisis was defined as ( 1 ) a rise of ICP of more than 25 mm Hg ( n = 22 ) , or ( 2 ) pupillary abnormality ( n=3 ) , or ( 3 ) a combination of both ( n=5 ) . Baseline treatment was performed according to a st and ardized protocol . For initial treatment , the patients were r and omly assigned to either infusion of 100 mL HS-HES or 40 g mannitol over 15 minutes . For repeated treatments the 2 substances were alternated . ICP , blood pressure , and cerebral perfusion pressure ( CPP ) were monitored over 4 hours . Blood gases , hematocrit , blood osmolarity , and sodium were measured before and 15 and 60 minutes after the start of infusion . Treatment was regarded as effective if ICP decreased > 10 % below baseline value or if the pupillary reaction had normalized . RESULTS Treatment was effective in all 16 HS-HES-treated and in 10 of 14 mannitol-treated episodes . ICP decreased from baseline values in both groups , P < 0.01 . The maximum ICP decrease was 11.4 mm Hg ( after 25 minutes ) in the HS-HES-treated group and 6.4 mm Hg ( after 45 minutes ) in the mannitol-treated group . There was no constant effect on CPP in the HS-HES-treated group , whereas CPP rose significantly in the mannitol-treated group . Blood osmolarity rose by 6.2 mmol/L in the mannitol-treated group and by 10.5 mmol/L in the HS-HES-treated group ; sodium fell by 3.2 mmol/L in the mannitol and rose by 4.1 mmol/L in the HS-HES-treated group . CONCLUSIONS Infusion of 40 g mannitol and 100 mL HS-HES decreases increased ICP after stroke . The maximum effect occurs after the end of infusion and is visible over 4 hours . HS-HES seems to lower ICP more effectively but does not increase CPP as much as does mannitol In a prospect i ve study , we r and omly allocated 70 patients with acute ischemic stroke to two therapy groups . Up to interim analysis , 33 patients underwent bloodletting , with simultaneous infusion of an identical volume of hydroxyethyl starch ( 10 % , 200/0.5 ) . The target hematocrit was 35 % . A control group of 37 patients did not receive hemodilution . Apart from an unequal sex distribution , the two groups were comparable with regard to age , cardiovascular risk factors , and medical history . In the hemodilution group , the mean hematocrit fell from 44.4 % to 37.7 % . After 14 days , improvement on the neurological score scale was 3.3 points in the hemodilution group compared with 6.5 points in the control group ( p = 0.12 ) . Subgroups with early inclusion ( less than 12 hours ) or pronounced lowering of hematocrit ( greater than 15 % of initial hematocrit ) also did not profit from hemodilution . Clinical deterioration observed in eight hemodilution group patients ( p less than 0.01 ) led to discontinuation of the study for ethical reasons BACKGROUND In animal models of ischaemic stroke , 25 % albumin reduced brain infa rct ion and improved neurobehavioural outcome . In a pilot clinical trial , albumin doses as high as 2 g/kg were safely tolerated . We aim ed to assess whether albumin given within 5 h of the onset of acute ischaemic stroke increased the proportion of patients with a favourable outcome . METHODS We did a r and omised , double-blind , parallel-group , phase 3 , placebo-controlled trial between Feb 27 , 2009 , and Sept 10 , 2012 , at 69 sites in the USA , 13 sites in Canada , two sites in Finl and , and five sites in Israel . Patients aged 18 - 83 years with ischaemic ( ie , non-haemorrhagic ) stroke with a baseline National Institutes of Health stroke scale ( NIHSS ) score of 6 or more who could be treated within 5 h of onset were r and omly assigned ( 1:1 ) , via a central web-based r and omisation process with a biased coin minimisation approach , to receive 25 % albumin ( 2 g [ 8 mL ] per kg ; maximum dose 750 mL ) or the equivalent volume of isotonic saline . All study personnel and participants were masked to the identity of the study drug . The primary endpoint was favourable outcome , defined as either a modified Rankin scale score of 0 or 1 , or an NIHSS score of 0 or 1 , or both , at 90 days . Analysis was by intention to treat . Thrombolytic therapies were permitted . This trial is registered with Clinical Trials.gov , number NCT00235495 . FINDINGS 422 participants were r and omly assigned to receive albumin and 419 to receive saline . On Sept 12 , 2012 , the trial was stopped early for futility ( n=841 ) . The primary outcome did not differ between patients in the albumin group and those in the saline group ( 186 [ 44 % ] vs 185 [ 44 % ] ; risk ratio 0·96 , 95 % CI 0·84 - 1·10 , adjusted for baseline NIHSS score and thrombolysis stratum ) . Mild-to-moderate pulmonary oedema was more common in patients given albumin than in those given saline ( 54 [ 13 % ] of 412 vs 5 [ 1 % ] of 412 patients ) ; symptomatic intracranial haemorrhage within 24 h was also more common in patients in the albumin group than in the placebo group ( 17 [ 4 % ] of 415 vs 7 [ 2 % ] of 414 patients ) . Although the rate of favourable outcome in patients given albumin remained consistent at 44 - 45 % over the course of the trial , the cumulative rate of favourable outcome in patients given saline rose steadily from 31 % to 44 % . INTERPRETATION Our findings show no clinical benefit of 25 % albumin in patients with ischaemic stroke ; however , they should not discourage further efforts to identify effective strategies to protect the ischaemic brain , especially because of pre clinical literature showing convincing proof-of-principle for the possibility of this outcome . FUNDING National Institute of Neurological Disorders and Stroke , US National Institutes of Health ; and Baxter Healthcare Corporation In a multicenter trial , 183 patients with acute ischemic stroke of less than 48 hours ' duration and hematocrits of 38 - 50 % were r and omized to st and ardized hemodilution treatment ( venesection and dextran 40 administration ) and 190 to a control group . We have previously reported that there were no beneficial effects of hemodilution in the total patient population . In this report , the case fatality rates and neurologic outcome in survivors ( 3 months ' follow-up ) in subsets of patients have been analyzed . The patients were subgrouped by sex , age , medical history , smoking habits , delay from the onset of symptoms to the start of treatment , hematocrit at entry , venesection volume , neurologic score at entry into the study , blood pressure changes in the acute phase , presence of atrial fibrillation , location of brain lesion by computed tomography , type of diagnostic procedures , and hospital setting . No subset in which hemodilution reduced mortality or improved neurologic outcome could be identified . Case fatality rate was apparently higher in hemodiluted patients with infa rct ion affecting deep brain structures than in control patients with such lesions . By simple clinical criteria , we have been unable to define subsets of stroke patients who benefit from the present st and ardized regimen of moderate hemodilution . The sample sizes are , however , too small to refute the possibility that a modest clinical effect of hemodilution may be present in some patients with stroke BACKGROUND AND PURPOSE Experimental studies suggest a beneficial effect of hemodilution on acute ischemic stroke . This was not proven by previous multicenter trials in the clinical setting . Various reasons have been suggested for the failure of these studies , which we attempted to consider in the Multicenter Austrian Hemodilution Stroke Trial ( MAHST ) . METHODS MAHST is a r and omized , double-blind , placebo-controlled study of hypervolemic hemodilution ( HHD ) within 6 hours of a clinical ly first ischemic stroke localized in the middle cerebral artery territory . The treatment consisted of 10 % hydroxyethyl starch 200/0.5 ( HES ) and was tested against pure rehydration with Ringer 's lactate over a period of 5 days . Our primary outcome measure was clinical improvement within 7 days as measured by the Grade d Neurologic Scale ( GNS ) . We performed an adaptive interim analysis to reevaluate the study goal after entering half of the projected number of patients ( n = 200 ) . At least 600 patients per group would have been required for significant results , and therefore we decided to terminate the trial . RESULTS Ninety-eight patients received HHD and 102 patients placebo . The baseline characteristics were comparable between both groups . In the HHD group the absolute reduction of the hematocrit was 2.5 % on day 2 with a maximum of 3.7 % on day 5 , which compares with a reduction in the placebo group of 1 % and 1.9 % , respectively . Intention-to-treat analysis showed no significant difference of the change of the GNS scores between HHD-treated ( median , -8.5 ; 95 % confidence interval , -14.2 to -4.0 ) and placebo-treated patients ( median , -6.0 ; 95 % confidence interval , -11.0 to 0.0 ) on day 7 , and GNS scores remained similar in both treatment groups throughout the trial . At 3 months , slightly more HHD patients showed complete independence on the Barthel Index ( 28 versus 24 ) , and fewer HHD than placebo patients had died ( 13 versus 17 ) , but these differences were not statistically significant . HHD treatment was not associated with any specific adverse event . CONCLUSIONS Mild HHD is safe but failed to demonstrate a significant beneficial effect over the pure rehydration regimen in patients with acute ischemic stroke In a r and om manner , 100 patients with acute cerebral infa rct ion due to thromboembolism were assigned to two groups . The patients in one group received continuous intravenous therapy with dextran 40 for three days ; the others received an equivalent volume of fluid without the dextran 40 . In the treated group , levels of dextran 40 remained greater than 1 % for three to five days after the infusion was stopped . The group treated with dextran 40 showed lower mortality and better quality of survival in terms of the neurological status . The improvement in the treated group was significantly better than in the untreated group ( OBJECTIVE To determine the effect of normovolaemic haemodilution in patients after a cerebrovascular accident . DESIGN Prospect i ve , r and omized clinical trial . SETTING St Lucas Hospital , Amsterdam . METHOD Normovolaemic haemodilution was achieved by means of bloodletting and administration of a 20 % solution of albumin plus crystalline infusion fluids under haemodynamic and rheological monitoring during the acute phase of the cerebral infa rct ion . All patients were subjected to general intensive care and monitoring with a pulmonary artery catheter . This custom-tailored fluid therapy was guided by a pulmonary wedge pressure of 12 mm Hg ( SD 3 ) and a haematocrit ( Ht ) of 0.32 l/l ( SD 0.02 ) . The control group only received individually dosed rehydration with crystalline infusion fluids . Endpoints of the study after 3 months were mortality and dependence/independence concerning everyday functioning . RESULTS The results in the total haemodilution group and the control group did not differ significantly . However , in the subgroup with normal Ht ( < 0.45 l/l ; n = 201 ) there was a significant reduction ( p < 0.05 ) of the mortality after 3 months ( 27 % and 16 % , respectively ) and an increase of independence at home ( 35 % and 48 % , respectively ) due to a reduction of the viscosity by means of haemodilution with albumin ( a specific viscosity effect in the normovolaemic group ) . In the control group with raised Ht ( dehydration ; Ht > or = 0.45 l/l ; n = 50 ) there was a significant decrease ( p < 0.005 ) of the mortality after 3 months ( 27 % and 8 % , respectively ) and an increase of independence at home ( 35 % and 59 % , respectively ) compared with the control group with normal Ht without signs of dehydration ( Ht < 0.045 l/l ; n = 102 ) , due to rehydration exclusively with crystalline infusion fluids ( a specific rehydration effect in the dehydrated group ) . CONCLUSION In cerebrovascular accident patients haemodilution should be adjusted individually ; in normovolaemic patients ha
Output:
| The overall results of this review showed no clear evidence of benefit of haemodilution therapy for acute ischaemic stroke .
These results are compatible with no persuasive beneficial evidence of haemodilution therapy for acute ischaemic stroke .
This therapy has not been proven to improve survival or functional outcome |
MS213295 | ***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: The goal of the current clinical study , conducted in the United States ( US ) , was to evaluate the efficacy and tolerability of vortioxetine 5 mg vs placebo in adults with a primary diagnosis of generalized anxiety disorder ( GAD ; HAM-A total score ≥20 and MADRS score ≤16 ) . Subjects were r and omized ( 1:1 ) to receive vortioxetine 5 mg ( n=152 ) or placebo ( n=152 ) for 8 weeks . Efficacy was assessed using change from baseline in HAM-A total scores after 8 weeks of treatment compared with placebo , using mixed-model repeated measures ( MMRM ) analyses . Adverse events ( AEs ) were assessed throughout the study . A total of 304 subjects were r and omized ( mean age , 41.2 years ) . After 8 weeks of treatment , there was no statistically significant difference in the reduction in HAM-A total score from baseline between the Vortioxetine ( n=145 ) and placebo ( n=145 ) groups . There were no statistically significant differences in any key secondary efficacy outcome between vortioxetine and placebo . Factors potentially contributing to the differences between the results of this study and those of one of identical design conducted outside the US are discussed . The most common treatment-emergent AEs were nausea , headache , dizziness , and dry mouth . Nausea was more frequently reported in the vortioxetine group ( 25 % vs 4.6 % for the placebo group ) . Most AEs were mild to moderate in severity . In conclusion , in this trial , vortioxetine did not improve symptoms of GAD ( compared with placebo ) over 8 weeks of treatment . Vortioxetine was well tolerated in this study Background Cigarette smoking is a tough addiction to break . Therefore , improved approaches to smoking cessation are necessary . The electronic-cigarette ( e-Cigarette ) , a battery-powered electronic nicotine delivery device ( ENDD ) resembling a cigarette , may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption . Efficacy and safety of these devices in long-term smoking cessation and /or smoking reduction studies have never been investigated . Methods In this prospect i ve proof-of-concept study we monitored possible modifications in smoking habits of 40 regular smokers ( unwilling to quit ) experimenting the ' Categoria ' e-Cigarette with a focus on smoking reduction and smoking abstinence . Study participants were invited to attend a total of five study visits : at baseline , week-4 , week-8 , week-12 and week-24 . Product use , number of cigarettes smoked , and exhaled carbon monoxide ( eCO ) levels were measured at each visit . Smoking reduction and abstinence rates were calculated . Adverse events and product preferences were also review ed . Results Sustained 50 % reduction in the number of cig/day at week-24 was shown in 13/40(32.5 % ) participants ; their median of 25 cigs/day decreasing to 6 cigs/day ( p < 0.001 ) . Sustained 80 % reduction was shown in 5/40(12.5 % ) participants ; their median of 30 cigs/day decreasing to 3 cigs/day ( p = 0.043 ) . Sustained smoking abstinence at week-24 was observed in 9/40(22.5 % ) participants , with 6/9 still using the e-Cigarette by the end of the study . Combined sustained 50 % reduction and smoking abstinence was shown in 22/40 ( 55 % ) participants , with an overall 88 % fall in cigs/day . Mouth ( 20.6 % ) and throat ( 32.4 % ) irritation , and dry cough ( 32.4 % ) were common , but diminished substantially by week-24 . Overall , 2 to 3 cartridges/day were used throughout the study . Participants ' perception and acceptance of the product was good . Conclusion The use of e-Cigarette substantially decreased cigarette consumption without causing significant side effects in smokers not intending to quit ( http:// Clinical Trials.gov number NCT01195597 ) Although constipation is a well-known side effect of calcium channel blockers such as verapamil , this side effect has not been evaluated in a quantitative manner . In a double-blind , r and omized , crossover trial , the effect of verapamil ( 240 mg/day ) was compared to placebo in 15 normal male volunteers . Subjects recorded their bowel movements and any side effects . Scintigraphy was used to quantitate gastric emptying , small intestinal transit , and colonic transit . In the study period of four days , verapamil did not change the frequency , consistency , or passage of bowel movements . A significantly increased number of side effects was noted during verapamil treatment — notably abdominal pain and dry mouth . The slope of gastric emptying was not significantly different for verapamil ( 0.012±0.02 ) than for placebo ( 0.013±0.001 ) . Distal ileum filling was also not different for verapamil ( 0.41±0.13%/min ) than placebo ( 0.33±0.05%/min ) . Progression of the colonic geometric center was significantly delayed at 48 hr by verapamil ( 5.2±0.4 vs 6.2±0.23;P<0.01 ) . This study suggests that the constipating effect of verapamil is due to a delay of colonic transit and not due to an effect on upper gastrointestinal transit Background In clinical practice , clinicians often need to switch antipsychotic medications in patients with schizophrenia to optimize treatment outcomes . Here , we describe the safety and tolerability of switching existing antipsychotic treatments to asenapine or olanzapine monotherapy using various switching regimens . Methods Data were pooled from 949 patients in two 26-week r and omized double-blind studies . Patients with persistent negative symptoms of schizophrenia , stable for at least 5 months prior to screening and 1 additional month before r and omization , were r and omized to and treated with either asenapine ( n = 485 ) or olanzapine ( n = 464 ) , and were tapered off existing antipsychotic(s ) at variable rates within 28 days . Results Prior to r and omization , most patients were treated with second-generation antipsychotics ( SGAs ) ( asenapine : 79.6 % ; olanzapine : 78.2 % ) and first-generation antipsychotics ( FGAs ) ( 31.1 % ; 29.7 % ) , while depot formulations were used by 12.4 % and 11.4 % , respectively . Median time to taper off previous antipsychotics was 7 days , with approximately 40 % of patients abruptly discontinuing their previous medication . Similar percentages of patients in each group reported at least one adverse event ( AE ) ( asenapine : 76.9 % ; olanzapine : 75.2 % ) . The majority of AEs occurred within the first 28 days . The most frequently reported AEs were somnolence , insomnia , and headache . The incidence of AEs in patients switching from SGAs , FGAs , or depot medications was similar between asenapine and olanzapine ( 77.5 % vs 74.6 % , 75.5 % vs 79.7 % , 85.0 % vs 86.8 % , respectively ) . AEs were more frequent in subjects previously treated with two antipsychotics ( asenapine : 79.4 % ; olanzapine : 83.9 % ) versus one antipsychotic ( asenapine : 76.3 % ; olanzapine : 72.2 % ) in the switch period . Conclusion The presented data from post hoc pooled analyses may provide practical guidance for physicians switching partially stabilized patients with schizophrenia and persistent negative symptoms to asenapine or olanzapine Although dopamine agonists ( DAs ) are sometimes perceived as poorly tolerated by the elderly , there is little clinical evidence to support these concerns . Safety and tolerability of rotigotine have been demonstrated in four 6-month r and omized placebo-controlled studies : two in early Parkinson 's disease ( PD ) and two in advanced PD . A post hoc analysis of data from these pivotal trials was carried out to compare the adverse event ( AE ) profiles of younger and older patient population s. Data from early and advanced PD trials were separately pooled and evaluated using two age cut-offs ( < 65 vs. ≥ 65 years ; < 75 vs. ≥ 75 years ) . For most AEs , no age-related differences in incidence were observed . In the early PD pool , nausea ( 38 % vs. 30 % ) and headache ( 15 % vs. 9 % ) were more frequent in younger ( < 65 years ) compared with older ( ≥ 65 years ) patients using the 65-year age cut-off . Using the 75-year cut-off , nausea ( 36 % vs. 21 % ) was more frequent in younger patients ( < 75 years ) and dizziness ( 15 % vs. 28 % ) was more frequent in older patients ( ≥ 75 years ) . In the advanced PD pool , nausea was more frequent in younger patients using the 65-year age cut-off ( 24 % vs. 19 % ) and falls were more frequent in older patients using the 75-year age cut-off ( 8 % vs. 13 % ) . In this relatively healthy population which included only few patients aged 75 years or older , rotigotine was generally well tolerated regardless of age . Data from more representative PD population s are required to fully assess potential risks of DA therapy in elderly patients Abstract Introduction / Objective : Executive function ( EF ) impairment in attention-deficit/hyperactivity disorder ( ADHD ) may account for behavioral symptoms such as poor concentration , impaired working memory , problems in shifting among tasks , and prioritizing and planning complex sets of tasks or completing long-term projects at work or school . Poor self-regulation and control of emotional behaviors frequently are seen in patients with ADHD . This study assessed EF behaviors in adults with ADHD at baseline and after 4 weeks of treatment with lisdexamfetamine dimesylate ( LDX ) . Methods : Executive function behavior was assessed using the Brown Attention-Deficit Disorder Scale ( BADDS ) during the 4-week open-label dose-optimization phase prior to a 2-period , r and omized , double-blind , placebo-controlled crossover study of LDX ( 30–70 mg/day ) . The ADHD Rating Scale IV ( ADHD-RS-IV ) with adult prompts assessed ADHD symptoms . Change in EF behavioral symptoms was evaluated based on week 4 BADDS total and cluster scores ; analyses of shifts from baseline among subjects with BADDS scores < 50 , 50 to 59 , 60 to 69 , and ≥ 70 ; and scores less than or greater than baseline 90 % confidence range ( eg , reliably improved or worsened , respectively ) . Treatment-emergent adverse events ( TEAEs ) were described . Results : At week 4 , BADDS total and cluster scores were reduced ( ie , improved ; all P < 0.0001 vs baseline [ n = 127 ] ) . The ADHD-RS-IV with adult prompts scores also improved ( all P < 0.0001 vs baseline ) . At week 4 , 62.7 % of subjects had a BADDS total score of < 50 , and 78.9 % were reliably improved ; 1.4 % were reliably worsened . Common TEAEs ( ≥ 5 % ) during the dose-optimization phase were decreased appetite ( 36.6 % ) , dry mouth ( 30.3 % ) , headache ( 19.7 % ) , insomnia ( 18.3 % ) , upper respiratory tract infection ( 9.9 % ) , irritability ( 8.5 % ) , nausea ( 7.7 % ) , anxiety ( 5.6 % ) , and feeling jittery ( 5.6 % ) . Conclusion : Clinical ly optimized doses of LDX ( 30–70 mg/day ) significantly improved EF behaviors in adults with ADHD . Treatment-emergent adverse events with LDX were consistent with those observed with long-term stimulant use Background The current article is a systematic review concerning the efficacy and safety of aripiprazole in the treatment of bipolar disorder . Methods A systematic Medline and repositories search concerning the usefulness of aripiprazole in bipolar disorder was performed , with the combination of the words ' aripiprazole ' and ' bipolar ' . Results The search returned 184 articles and was last up date d on 15 April 2009 . An additional search included repositories of clinical trials and previous systematic review s specifically in order to trace unpublished trials . There were seven placebo-controlled r and omised controlled trials ( RCTs ) , six with comparator studies and one with add-on studies . They assessed the usefulness of aripiprazole in acute mania , acute bipolar depression and during the maintenance phase in comparison to placebo , lithium or haloperidol . Conclusion Aripiprazole appears effective for the treatment and prophylaxis against mania . The data on bipolar depression are so far negative , however there is a need for further study at lower dosages . The most frequent adverse effects are extrapyramidal signs and symptoms , especially akathisia , without any significant weight gain , hyperprolactinaemia or
Output:
| Although many medications may affect the salivary flow rate and composition , most of the studies considered only xerostomia . |
MS213296 | ***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: Editor 's Note : This issue of In the Clinic has been up date d. One third of the world population has Mycobacterium tuberculosis infection ( 1 ) . Despite recent progress in the United States , tuberculosis infection remains prevalent in immigrants , immunosuppressed persons , and other high-risk groups ( 3 ) . Latent tuberculosis infection ( LTBI ) is the most prevalent form of tuberculosis in the United States ( 2 ) . LTBI can progress to active tuberculosis disease , especially in individuals with a suppressed cell-mediated immunity . Active tuberculosis disease in immuno-suppressed patients can be difficult to diagnose and can progress to disseminated forms of tuberculosis disease associated with high mortality ( 4 ) . New methods of diagnosing tuberculosis disease have entered practice in recent years ( 5 ) , but the diagnosis of LTBI can be challenging in some high-risk population s ( 6 , 7 ) . The introduction of directly observed therapy with first-line antituberculous regimens ( 8) was an important advance in therapy , but multidrug-resistant tuberculosis ( MDR-TB ) and the extensively resistant form of MDR-TB remain significant threats to international and local tuberculosis control efforts ( 9 , 10 ) . Screening and Prevention Who should be screened for tuberculosis ? Clinicians should screen all individuals at risk for tuberculosis infection , including close contacts of persons who have active pulmonary tuberculosis . Table 1 identifies asymptomatic individuals who should be screened because they are at high risk for exposure to active tuberculosis or at high risk for disease once infected . Table 1 . Risk Factors for Tuberculosis Infection or Progression to Disease After Infection What tests are used to screen for tuberculosis ? The tuberculin skin test ( TST ) with purified protein derivative ( PPD ) and the Mantoux method have been in use for more than 100 years to screen for tuberculosis . The TST result may not become positive for 8 to 10 weeks after exposure to active tuberculosis . The TST can give false-positive results in patient with previous bacille Calmette-Gurin ( BCG ) vaccination or other mycobacterial infections and false-negative results in anergic or immunosuppressed patients ; however , previous BCG vaccination should not change the interpretation of the TST in most adults . The newer interferon- release assays ( IGRAs ) , including the 2 U.S. Food and Drug Administration-approved commercial tests ( T-SPOT.TB [ Oxford Immunotec , Oxford , United Kingdom ] , and QuantiFERON-TB Gold and its In-tube version [ Cellestis , Valencia , California ] ) can also be used in circumstances in which the TST is currently used ( 11 ) . IGRAs assess the T-cell lymphocyte response to specific M. tuberculosis antigens ( for example , ESAT-6 and CFP-10 ) and are more specific , and possibly more sensitive , than TST ( 12 , 13 ) . However , information about IGRA performance is limited in immunocompromised patients and patients receiving immunosuppressive therapy ( 6 , 14 ) . The commercially available IGRAs also have limitations ; indeterminate results can occur in immunosuppressed patients , more so with QuantiFERON TB Gold than T-SPOT.TB ( 6 ) . Discordant results between TST and IGRA testing also occur in about 20 % of individuals ( 13 ) , which could be related , at least in part , to differences in performance characteristics of these tests ( 5 ) and to characteristics of the studied population s , such as the prevalence of persons previously vaccinated with BCG and the proportion of persons born outside the United States ( 15 , 16 ) . In addition to their improved specificity compared with TST , IGRAs have several practical advantages . They do not require a second visit for reading and they do not trigger amnestic responses . Longitudinal data supporting the predictive value of IGRA testing is limited , however , in contrast to the many studies of TST for predicting active tuberculosis ( 17 ) . A recent study from a high-incidence area of tuberculosis in Africa found that initial test results were positive in only 56 % of TST testing and 52 % of IGRA testing in close household contacts who developed active tuberculosis during 2 years of follow up . Of these close household contacts who developed active tuberculosis , 71 % had a positive result with either TST or IGRA during their initial evaluations ( 18 ) . Another prospect i ve study ( 19 ) from a country with a low incidence of tuberculosis suggests that IGRA testing could be more accurate than TST for diagnosing LTBI and for detecting individuals who will progress to active tuberculosis , but more longitudinal data are needed , especially in immunosuppressed individuals . What can patients do to reduce their likelihood of becoming infected with tuberculosis ? Tuberculosis is mainly transmitted by the airborne route from a patient with respiratory symptoms , and its ability to infect others decreases significantly after 2 weeks of effective therapy ( 20 , 22 ) . Therefore , prevention of tuberculosis transmission involves promptly identifying and treating patients with active tuberculosis . For hospitalized patients , prevention includes isolating patients with tuberculosis from other patients and strictly applying other hospital infection control practice s ( 23 , 24 ) . Patients usually can be removed from airborne infection isolation when they are no longer considered infectious . Patients are no longer infectious when they are on adequate tuberculosis drug therapy , have had a significant clinical response to therapy , and have had negative results on 3 consecutive sputum smears for acid-fast bacilli ( AFB ) . Some patients can be isolated from outsiders at home after appropriate evaluation and the initiation of outpatient treatment . Isolation of patients at home assumes that household contacts already have been exposed and that further exposure will not affect their outcomes . Two studies , one in India and one in Arkansas , showed similar rates of disease or infection in exposed household contacts whether the patient was admitted to the hospital or allowed to remain at home for initial treatment ( 25 , 26 ) . However , if household contacts of the patients with infectious tuberculosis are at high risk ( for example , infants or immuno-compromised persons ) , housing the patient elsewhere until he or she meets noninfectious criteria should be strongly considered . Hospitalization may be required until housing can be obtained ( 27 ) . Educating health care workers to evaluate exposed persons for active tuberculosis by obtaining sputum for AFB testing when they have respiratory symptoms has been shown to improve the case detection rates in primary care setting s ( 28 ) . What should clinicians tell patients with active tuberculosis to protect household members and other contacts from infection ? Clinicians should teach patients to cough into disposable tissues and to cover their nose and mouth when coughing or sneezing to contain droplet nuclei before they are expelled into the air . Patients who are placed in airborne infection isolation rooms should be educated about the transmission of tuberculosis , the reasons for isolation , and the importance of staying in their rooms . Every effort should be made to help the patient follow the isolation policy ( 29 ) . Hospital employees and physicians who come in contact with an infectious or suspected infectious patient should wear previously fitted particulate respirators certified by the National Institute for Occupational Safety and Health for protection against tuberculosis , which does not include surgical masks . What are the physician 's public health responsibilities after making a diagnosis of active tuberculosis ? All 50 U.S. states require physicians to notify public health authorities about all patients suspected of having active tuberculosis ( 22 , 23 ) , which can enable identification of other cases and potentially prevent further transmission of tuberculosis in the community . Genetic fingerprinting of tuberculosis isolates during an outbreak can help public health authorities detect tuberculosis infection in the community ( 30 ) . Clinical Bottom Line : Screening and Prevention Clinicians should screen persons who have close contact with a person who has active pulmonary tuberculosis , and screen other persons who are at high risk for infection or for progression to disease once infected . Clinicians should screen with TST or IGRAs and should prevent infection by identifying and treating persons with active pulmonary tuberculosis . Patient airborn infection isolation is an important part of early treatment and prevention of transmission . Persons who provide care to patients with active pulmonary tuberculosis should wear particulate respirators . Clinicians should notify public health authorities about patients with suspected active tuberculosis . Diagnosis What signs and symptoms suggest active tuberculosis ? Although tuberculosis can cause disease in many parts of the body , this article focuses on pulmonary tuberculosis because it is the most common form of the disease . Clinicians should consider a diagnosis of pulmonary tuberculosis and evaluate patients for tuberculosis if the patient has constitutional or pulmonary signs and symptoms , such as cough longer than 2 to 3 weeks ( may not be productive until later in course of disease ) , hemoptysis ( more likely with cavitation and rarely a presenting symptom ) , chest pain , fever , chills , night sweats , weight loss , easy fatigability , or anorexia . Some patients have classic signs and symptoms , but it is rare for someone to have most of the classic signs and symptoms except in advanced disease , and many patients will have few of them . Some patients with active pulmonary tuberculosis infection can be fairly asymptomatic . Table 2 shows some of the main findings from the history and the physical examination that are associated with active tuberculosis disease . Table 2 . Findings from the History and Physical Examination in Patients with Active Tuberculosis One study review ed 101 patients admitted to respiratory isolation to
Output:
| Developed countries were the most productive in the field of central venous catheters .
Most meta-analyses focused on complications associated with central -venous catheters such as infection and thrombosis |
MS213297 | ***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: The aim of this study was to assess the effectiveness of a 24-week exercise protocol carried out in geothermal spring water to improve overall physical function and muscle mass in a group of healthy elderly subjects . A further aim was to compare this water-based protocol with a l and -based protocol and a control group . For this purpose , 59 subjects were recruited and r and omly allocated to three groups : aquatic group ( AG ) , l and group ( LG ) , and control group ( CG ) . AG and LG followed a 6-month , twice-weekly , multimodality exercise intervention . AG underwent the protocol in hot-spring water ( 36 ° C ) while LG did it in a l and -based environment . After the intervention , knee-extension strength was maintained in AG and LG . The 8-foot up- and -go test showed a reduction in both exercise groups ( AG −19.3 % , P < 0.05 ; LG −12.6 % , P < 0.05 ) , with a significantly greater decrease in AG . The back-scratch test revealed an improvement only in AG ( 25.8 % ; P < 0.05 ) , while the sit- and -reach test improved in all groups . Finally , AG reduced fat mass by 4 % ( P < 0.05 ) , and dominant forearm fat decreased by 9.2 % ( P < 0.05 ) . In addition , calf muscle density increased by 1.8 % ( P < 0.05 ) . In summary , both water- and l and -based activities were beneficial in maintaining strength and in improving lower-body flexibility . Aquatic exercise appeared a better activity to improve dynamic balance . Thermal swimming pools and the use of rating of perceived exertion as a method of exercise monitoring should be considered potentially useful tools to enhance physical performance and body composition in healthy elderly The aim of the present study was to evaluate the effects of an AAG on BMD , osteocalcin and functional autonomy in older women . The sample consisted of eighty-two post-menopausal women with low BMD , r and omly divided into two groups : the Aquatic Aerobics Group [ AAG ; n=42 ; age : 66.8±4.2years ] , su bmi tted to two weekly sessions over eight months , and the Control Group ( GC ; n=42 ; age : 66.9±3.2years ) , which did not participate in regular exercise . BMD was measured by Dual Energy X-ray Absorptiometry [ DXA ] of the lumbar and femur , and serum osteocalcin was measured using electrochemiluminescence . A functional autonomy assessment protocol ( GDLAM , 2004 ) was also applied . Statistical analyses used were repeated measures ANOVA and Tukey 's post hoc tests . The results showed a significant improvement in tests following the GDLAM protocol : 10 meters walk ( 10mw ) -p=0.003 ; rising from a ventral decubitus position ( RVDP ) - Δ%=0.78 , p<0.001 ; rising from a chair and moving around the house ( RCMH ) -p<0.001 and autonomy index ( AI ) -p=0.007 , with more favorable results observed in the AAG when compared to the CG . The AAG achieved the best results for BMD ; however , no inter or intragroup statistical differences were recorded for total femur -p=0.975 and lumbar L(2)-L(4)p=0.597 . For serum osteocalcin , intra and intergroup statistical differences of p=0.042 and p=0.027 were observed in the AAG , respectively . This demonstrates that an eight-month aquatic aerobic exercise program can improve functional autonomy and osteocalcin levels , although training did not improve lumbar and total femur BMD in the older women BACKGROUND Fractures have been associated with subsequent increases in mortality , but it is unknown how long that increase persists . METHODS A total of 5580 women from a large community-based , multicenter US prospect i ve cohort of 9704 ( Study of Osteoporotic Fractures ) were observed prospect ively for almost 20 years . We age-matched 1116 hip fracture cases with 4 control participants ( n = 4464 ) . To examine the effect of health status , we examined a healthy older subset ( n = 960 ) 80 years or older who attended the 10-year follow-up examination and reported good or excellent health . Incident hip fractures were adjudicated from radiology reports by study physicians . Death was confirmed by death certificates . RESULTS Hip fracture cases had 2-fold increased mortality in the year after fracture compared with controls ( 16.9 % vs 8.4 % ; multivariable adjusted odds ratio [ OR ] , 2.4 ; 95 % CI , 1.9 - 3.1 ] . When examined by age and health status , short-term mortality was increased in those aged 65 to 69 years ( 16.3 % vs 3.7 % ; OR , 5.0 ; 95 % CI , 2.6 - 9.5 ) , 70 to 79 years ( 16.5 % vs 8.9 % ; OR , 2.4 ; 95 % CI , 1.8 - 3.3 ) , and only in those 80 years or older with good or excellent health ( 15.1 % vs 7.2 % ; multivariable adjusted OR , 2.8 ; 95 % CI , 1.5 - 5.2 ) . After the first year , survival of hip fracture cases and controls was similar except in those aged 65 to 69 years , who continued to have increased mortality . CONCLUSIONS Short-term mortality is increased after hip fracture in women aged 65 to 79 years and in exceptionally healthy women 80 years or older . Women 70 years or older return to previous risk levels after a year . Interventions are needed to decrease mortality in the year after hip fracture , when mortality risk is highest OBJECTIVE To analyze the effects of a water-based exercise program on peak torque ( PT ) and rate of torque development ( RTD ) during maximal voluntary ballistic isometric contractions of the lower limb muscles and the performance of a number of functional tests in the elderly . METHOD Thirty-seven elderly were r and omly assigned to water-based training ( 3 d/wk for 12 wk ) or a control group . Extensor and flexor PT and RTD of the ankle , knee , and hip joints and functional tests were evaluated before and after training . RESULTS PT increased after training for the hip flexors ( 18 % ) and extensors ( 40 % ) and the plantar-flexor ( 42 % ) muscles in the water-based group . RTD increased after training for the hip-extensor ( 10 % ) , knee-extensor ( 11 % ) , and ankle plantar-flexor ( 27 % ) muscles in the water-based group . Functional tests also improved after training in the water-based group ( p < .05 ) . CONCLUSION The water-based program improved PT and RTD and functional performance in the elderly Background and Purpose Aquatic physical therapy is frequently used in the management of patients with hip and knee osteoarthritis ( OA ) , yet there is little research establishing its efficacy for this population . The purpose of this study was to evaluate the effects of aquatic physical therapy on hip or knee OA . Subjects A total of 71 volunteers with symptomatic hip OA or knee OA participated in this study . Methods The study was design ed as a r and omized controlled trial in which participants r and omly received 6 weeks of aquatic physical therapy or no aquatic physical therapy . Outcome measures included pain , physical function , physical activity levels , quality of life , and muscle strength . Results The intervention result ed in less pain and joint stiffness and greater physical function , quality of life , and hip muscle strength . Totals of 72 % and 75 % of participants reported improvements in pain and function , respectively , compared with only 17 % ( each ) of control participants . Benefits were maintained 6 weeks after the completion of physical therapy , with 84 % of participants continuing independently . Discussion and Conclusion Compared with no intervention , a 6-week program of aquatic physical therapy result ed in significantly less pain and improved physical function , strength , and quality of life . It is unclear whether the benefits were attributable to intervention effects or a placebo response BACKGROUND Osteoporosis is a multifactorial progressive skeletal disorder characterized by reduced bone mass . Exercise is widely recommended to reduce osteoporosis , falls and related fragility fractures . The purpose of this study was to investigate the effects of l and exercise ( LE ) and aquatic exercise ( AE ) on physical function and bone mineral density ( BMD ) . MATERIAL AND METHODS Fifty-eight postmenopausal women , aged 50 - 70 years , diagnosed with osteoporosis according to BMD measures , enrolled in this study . The subjects were r and omly assigned to either the intervention group ( LE group ) or the control group ( AE group ) . Physical function and BMD were assessed in all subjects in both groups before and after 10 months of intervention . Muscle strength , flexibility , balance , gait time and pain were measured to assess physical function . Bone mineral density at the lumbar spine was measured by dual energy X-ray absorptiometry ( DEXA ) . RESULTS There were no significant differences between the two groups in the baseline anthropometric data . The two groups were similar with respect to age , weight , height , and body mass index ( p>0.05 ) . After the exercise program , muscle strength , flexibility , gait time , pain , and bone density ( p<0.001 ) improved significantly with LE compared to AE . There was no significant difference between the two groups with regard to balance at the 10-month follow-up . CONCLUSION Significant improvements in physical function and BMD suggest that LE is a possible alternative for postmenopausal women with OP Abstract . Osteoporosis is one of the most common skeletal disorders affecting postmenopausal women . The purpose of this study was to investigate whether a 24-week program of aerobic high-impact loading exercise was beneficial for enhancing physical fitness and bone mineral density ( BMD ) in osteopenic postmenopausal women . Forty-three postmenopausal women aged 48–65 years participated in this study . The BMD of the spine ( L2–L4 ) and right femoral neck of each woman was below 1 SD of the mean of premenopausal women , as examined by dual X-ray absorptiometry . The assignment of subjects into exercise or control group was not r and omized but based on each subject 's anticipated compliance to the 6-month long exercise program . Twenty-two subjects joined the exercise group and attended the training programs and 21 served as the control group . Exercise programs included treadmill walking at an intensity above 70 % of maximal oxygen consumption ( VO2max ) for 30 minutes , followed by 10 minutes of stepping exercise using a 20-cm-high bench . The program was conducted three times per week for 24 weeks . Physical fitness measurements included testing of flexibility , muscular strength and endurance , body composition , and cardiopulmonary fitness . The results showed that the quadriceps strength , muscular endurance , and VO2max in the exercise group had significant improvements , whereas no improvement was found in any of the physical fitness parameters in the control group . The BMD of the L2–L4 and the femoral neck in the exercise group increased 2.0 % ( P > 0.05 ) and 6.8 % ( P < 0.05 ) and those in the control group decreased 2.3 % ( P < 0.05 ) and 1.5 % ( P > 0.05 ) , respectively . In conclusion , aerobics combined with high-impact exercise at a moderate intensity was effective in off setting the decline in BMD in osteopenic postmenopausal women Summary In women aged 50 years or more who experienced a fracture , 81 % suffered a fragility fracture . Six to eight months after fragility fracture , 79 % had either not been investigated for osteoporosis or prescribed anti-fracture therapy . Despite fragility fractures being common in this population osteoporosis is under-diagnosed and under-treated . Introduction The objective of this study was to evaluate the diagnostic and treatment rates for osteoporosis six months following fragility fracture . Methods This prospect i ve cohort study was set in the general community from the Province of Quebec , Canada . Women at least 50 years of age who suffered a fracture were recruited during their initial visit to the hospital and had their fracture type classified as either fragility or traumatic . Six-to-eight months after fragility fracture , women were again contacted to evaluate the diagnostic and treatment rates of osteoporosis . Results Of the 2,075 women recruited over a 25 month period 1688 ( 81 % ) sustained a fragility fracture and 387 ( 19 % ) sustained a traumatic fracture . Nine hundred and three participants with a fragility fracture were again contacted six-to-eight months after fracture . For the 739 women not on treatment on the recruitment day , only 15.4 % initiated pharmacological therapy in the six-to-eight-month period following fracture and 79.0 % had either not been investigated for osteoporosis or prescribed anti-fracture treatment . Conclusions The proportion of fragility fractures to total fractures is higher than previously reported . Despite the availability of diagnostic modalities , effective treatments , and adequate health care assessment s , there is a substantial care gap in the management of osteoporosis PURPOSE The purpose of this study was to identify the effects of water-based exercises on the physical functions and quality of life ( QOL ) in community-dwelling elderly people with history of falling . MATERIAL S AND
Output:
| WBE may have benefits with respect to maintaining or improving bone health in postmenopausal women but less benefit when compared to LBE . |
MS213298 | ***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 Little is known about the long-term impact of and rogen deprivation therapy ( ADT ) on body composition in men with prostate cancer . We compared body composition parameters in men with non-metastatic prostate cancer on or not on therapy with healthy , age-matched controls at baseline and monitored changes over a 2-year period . METHODS We measured body fat mass and lean body mass in 81 men with prostate cancer on no ADT , 43 men on acute ADT ( less than 6 months ) , 67 men on chronic ADT ( more than 6 months ) and 53 age-matched healthy controls . Measurements were performed every 6 months for 2 years . RESULTS Men with prostate cancer on acute ADT ( mean 3 months ) had significant gains in body fat mass [ 1499.56+/-322.28 g ( mean+/-S.E. ) after 12 months , 2167.15+/-676.45 g after 24 months , p<0.01 for both ] and losses in lean body mass ( 929.74+/-296.36 g after 12 months , 1785.81+/-501.31 g after 24 months , p<0.01 for both ) over 2 years . Men on chronic ADT ( mean 31 months ) had smaller but still significant body composition changes over 24 months . Changes in body composition in men on no ADT were small and healthy controls had no significant changes . CONCLUSIONS Men with prostate cancer on ADT have significant gains in body fat mass and losses lean body mass over 2 years . These changes are most pronounced with initiation of ADT BACKGROUND AND PURPOSE The ongoing Early Prostate Cancer ( EPC ) programme is assessing bicalutamide ( ' Casodex ' ) 150 mg , either alone or as adjuvant to treatment of curative intent , in patients with localised or locally advanced prostate cancer ( n=8113 ) . This paper presents an exploratory analysis of the subgroup of the EPC programme who received radiotherapy with curative intent ( n=1370 ) in order to determine the efficacy ( in terms of progression-free survival [ PFS ] ) and tolerability of bicalutamide 150 mg in this setting . PATIENTS AND METHODS 1370 patients with T1 - 4 , MO , any N prostate cancer received bicalutamide 150 mg or placebo adjuvant to radiotherapy of curative intent . This analysis was undertaken at median 5.3 years ' follow-up . RESULTS In patients with locally advanced disease ( n=305 ) , bicalutamide adjuvant to radiotherapy significantly increased PFS by 53 % ( event-time ratio 1.53 ; 95 % confidence intervals [ CI ] 1.16 , 2.02 ) compared with placebo and reduced the risk of disease progression by 42 % ( hazard ration [ HR ] 0.58 ; 95 % CI 0.41 , 0.84 ; P=0.00348 ) . In these patients , objective progression was experienced by 33.5 % of those r and omised to bicalutamide versus 48.6 % for those r and omised to placebo . The between-group difference in patients with localised disease ( n=1065 ) failed to reach statistical significance ( HR 0.80 ; 95 % CI 0.62 , 1.03 ; P=0.088 ) . The most common adverse events were breast pain ( 74.8 % ) and gynaecomastia ( 66.6 % ) , which were mild to moderate in > 90 % of cases . CONCLUSIONS Bicalutamide 150 mg/day given as adjuvant to radiotherapy significantly improved PFS in patients with locally advanced prostate cancer . For patients with localised disease , the results at this stage from the radiotherapy subgroup and the overall EPC programme suggest that adjuvant hormonal therapy is currently not appropriate . There were no unexpected tolerability findings CONTEXT GnRH agonists markedly increase fat mass in men with prostate cancer , but little is known about the effects of treatment on insulin sensitivity . OBJECTIVE The objective of the study was to assess the effects of short-term GnRH agonist treatment on insulin sensitivity . DESIGN This was a prospect i ve 12-wk study . SETTING The study was conducted at a general clinical research center . PATIENTS OR OTHER PARTICIPANTS We studied 25 men with locally advanced or recurrent prostate cancer , no radiographic evidence of metastases , no history of diabetes mellitus , and no evidence of diabetes mellitus at baseline visit . INTERVENTION Leuprolide depot and bicalutamide were used in the study . MAIN OUTCOME MEASURES Oral glucose tolerance tests and body composition assessment by dual-energy x-ray absorptiometry were performed at baseline and wk 12 . The primary study outcome was change in insulin sensitivity index . RESULTS Mean ( + /- se ) percentage fat body mass increased by 4.3 + /- 1.3 % from baseline to wk 12 ( P = 0.002 ) . Insulin sensitivity index decreased by 12.9 + /- 7.6 % ( P = 0.02 ) . Insulin sensitivity by homeostatic model assessment decreased by 12.8 + /- 5.9 % ( P = 0.02 ) . Fasting plasma insulin levels increased by 25.9 + /- 9.3 % ( P = 0.04 ) . Mean glycosylated hemoglobin also increased significantly ( P < 0.001 ) . CONCLUSIONS Short-term treatment with leuprolide and bicalutamide significantly increased fat mass and decreased insulin sensitivity in men with prostate cancer . These observations suggest that GnRH agonists may increase the risk of diabetes mellitus and cardiovascular disease in older men OBJECTIVE Casodex ( Zeneca ) is a new potent , long‐acting non‐steroidal anti‐ and rogen , which produces and rogen deprivation by blocking the and rogen receptor . We evaluated the endocrine effects of Casodex 150 mg daily given in monotherapy as primary treatment for patients with prostate cancer PURPOSE To examine the effect of progressive resistance training on muscle function , functional performance , balance , body composition , and muscle thickness in men receiving and rogen deprivation for prostate cancer . METHODS Ten men aged 59 - 82 yr on and rogen deprivation for localized prostate cancer undertook progressive resistance training for 20 wk at 6- to 12-repetition maximum ( RM ) for 12 upper- and lower-body exercises in a university exercise rehabilitation clinic . Outcome measures included muscle strength and muscle endurance for the upper and lower body , functional performance ( repeated chair rise , usual and fast 6-m walk , 6-m backwards walk , stair climb , and 400-m walk time ) , and balance by sensory organization test . Body composition was measured by dual-energy x-ray absorptiometry and muscle thickness at four anatomical sites by B-mode ultrasound . Blood sample s were assessed for prostate specific antigen ( PSA ) , testosterone , growth hormone ( GH ) , cortisol , and hemoglobin . RESULTS Muscle strength ( chest press , 40.5 % ; seated row , 41.9 % ; leg press , 96.3 % ; P < 0.001 ) and muscle endurance ( chest press , 114.9 % ; leg press , 167.1 % ; P < 0.001 ) increased significantly after training . Significant improvement ( P < 0.05 ) occurred in the 6-m usual walk ( 14.1 % ) , 6-m backwards walk ( 22.3 % ) , chair rise ( 26.8 % ) , stair climbing ( 10.4 % ) , 400-m walk ( 7.4 % ) , and balance ( 7.8 % ) . Muscle thickness increased ( P < 0.05 ) by 15.7 % at the quadriceps site . Whole-body lean mass was preserved with no change in fat mass . There were no significant changes in PSA , testosterone , GH , cortisol , or hemoglobin . CONCLUSIONS Progressive resistance exercise has beneficial effects on muscle strength , functional performance and balance in older men receiving and rogen deprivation for prostate cancer and should be considered to preserve body composition and reduce treatment side effects PURPOSE Gonadotropin-releasing hormone agonists decrease bone mineral density , lean mass , and muscle size and increase fat mass in men with prostate cancer . Less is known about the effects of bicalutamide monotherapy on bone mineral density and body composition . PATIENTS AND METHODS In a 12-month , open-label study , we r and omly assigned 52 men with prostate cancer and no bone metastases to receive either leuprolide or bicalutamide ( 150 mg by mouth daily ) . Bone mineral density and body composition were measured by dual energy x-ray absorptiometry and quantitative computed tomography . RESULTS Mean ( + /- st and ard error ) bone mineral density of the posterior-anterior lumbar spine decreased by 2.5 % + /- 0.5 % in the leuprolide group and increased by 2.5 + /- 0.5 in the bicalutamide group from baseline to 12 months ( P < .001 ) . Mean changes in bone mineral density of the total body , total hip , femoral neck , and trabecular bone of the lumbar spine also differed significantly between groups ( P < or = .003 for each comparison ) . Fat mass increased by 11.1 % + /- 1.3 % in the leuprolide group and by 6.4 % + /- 1.1 % in the bicalutamide group ( P = .01 ) . Changes in lean mass , muscle size , and muscle strength were similar between the groups . Breast tenderness and enlargement were more common in the bicalutamide group than in the leuprolide group . Fatigue , loss of sexual interest , and vasomotor flushing were less common in the bicalutamide group than in the leuprolide group . CONCLUSION In men with prostate cancer , bicalutamide monotherapy increases bone mineral density , lessens fat accumulation , and has fewer bothersome side effects than treatment with a gonadotropin-releasing hormone agonist PURPOSE We evaluated changes in bone mineral density ( BMD ) , fat-free mass ( FFM ) and serum lipid levels during bicalutamide 150 mg monotherapy compared with medical castration for 2 years . MATERIAL S AND METHODS A total of 103 men with localized or locally advanced prostate cancer ( T1-T4 , Nx , M0 ) for whom immediate and rogen deprivation was indicated were enrolled in this prospect i ve , multicenter , open-label , parallel group study . Patients were r and omized to bicalutamide 150 mg once daily ( 51 ) or medical castration with a luteinizing hormone releasing hormone analogue ( 52 ) for 96 weeks . Primary end points were mean percent change from baseline in lumbar spine BMD , hip BMD and FFM at 96 weeks . Mean changes in lipid parameters with time were also evaluated . RESULTS BMD was maintained during bicalutamide 150 mg monotherapy ( + 2.42 % for lumbar spine BMD and + 1.13 % for hip BMD at week 96 ) , while castration was associated with a progressive loss in BMD ( -5.40 % and -4.39 % at week 96 , respectively , both p < 0.0001 at week 96 ) . There was no significant difference between bicalutamide 150 mg and castration in mean percent change from baseline in FFM ( -1.56 % and -3.86 % , respectively , at week 96 , p = 0.31 ) , although there was a trend for greater progressive loss over time with castration . Mean changes in lipid parameters were small and similar in the 2 groups . CONCLUSIONS Bicalutamide 150 mg monotherapy may offer an important advantage compared to castration in terms of bone loss and body composition for patients who require long-term and rogen deprivation for localized or locally advanced prostate cancer PURPOSE Radiation Therapy Oncology Group protocol 85 - 31 was design ed to evaluate the effectiveness of adjuvant and rogen suppression , using goserelin , in unfavorable prognosis carcinoma of the prostate treated with definitive radiotherapy ( RT ) . METHODS AND MATERIAL S Eligible patients were those with palpable primary tumor extending beyond the prostate ( clinical Stage T3 ) or those with regional lymphatic involvement . Patients who had undergone prostatectomy were eligible if penetration through the prostatic capsule to the margin of resection and /or seminal vesicle involvement was documented histologically . Stratification was based on histologic differentiation , nodal status , acid phosphatase status , and prior prostatectomy . The patients were r and omized to either RT and adjuvant goserelin ( Arm I ) or RT alone followed by observation and application of goserelin at relapse ( Arm II ) . In Arm I , the drug was to be started during the last week of RT and was to be continued indefinitely or until signs of progression . RESULTS Between 1987 and 1992 , when the study was closed , 977 patients were entered : 488 to Arm I and 489 to Arm II . As of July 2003 , the median follow
Output:
| More extensive changes were seen with longer duration of treatment .
Conclusions Substantial increases in fat and declines in lean mass were observed in prostate cancer patients treated with ADT .
Implication s for cancer survivorsProstate cancer survivors should be made aware of the side effect of treatment on body composition and further work is required to determine what interventions can minimize the impact of ADT on body composition and therefore what evidence based advice they should be provided with .
In general , though recommendation of a healthy diet and moderate exercise is reasonable |
MS213299 | ***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: An estimated 20 million Americans suffer from diabetes . Patients with non-insulin-dependent diabetes mellitus ( NIDDM ) comprise approximately 90 % of the diabetic population . An estimated 10 - 30 % of patients with NIDDM withdraw from their prescribed regimen within 1 year of diagnosis , and of the remainder , nearly 20 % administer insufficient medication to facilitate an adequate reduction in blood glucose . A r and omized trial was undertaken to discern the effect of pharmacy-based value-added utilities on prescription-refill compliance with sulfonylurea therapy and health service utilization . The subjects were 258 Medicaid beneficiaries from the state of South Carolina , previously untreated for NIDDM , prescribed 5 mg of the second-generation sulfonylurea glyburide twice daily , and monitored with regard to prescription-refill compliance and health service utilization for 1 year . Subjects provided informed consent and were r and omly assigned to one of four experimental groups : ( i ) the control cohort received st and ard pharmaceutical care with each dispensing of glyburide ; ( ii ) the second cohort received st and ard pharmaceutical care and was mailed a medication-refill reminder 10 days prior to each sequential refill date ; ( iii ) the third cohort received st and ard pharmaceutical care and was provided unit-of-use packaging with each prescription-refill request ; ( iv ) the fourth cohort received st and ard pharmaceutical care , mailed medication-refill reminders , and unit-of-use packaging . Analysis of variance ( ANOVA ) procedures revealed that patients receiving mailed prescription-refill reminders , unit-of-use packaging , or a combination of both interventions achieved a significant ( P < or = 0.05 ) increase in the Medication Possession Ratio ( MPR ) for sulfonylurea therapy relative to controls . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND : Concordance , which involves prescribing with rather than for patients , should result in less drug wastage ( non-use ) , but is proving hard to put into practice . One possible way of easing elderly people and prescribers toward concordance is to use a medicines organizer ( MO ) . OBJECTIVE : To document medication wastage , using a pharmacy-prepared reusable MO , and explore , using a qualitative approach , use of this information on communication of individuals ' drug regimens . METHODS : Sixty-two sheltered housing residents , aged ⩾60 years , participated in an exploratory controlled , matched study . The intervention group received medication in the MO , and the control group continued with st and ard packaging . Community pharmacists recorded details of wasted drugs returned during the 3-month study and , for the intervention group , 6 , 9 , and 12 months after the study . Medicines management data were collected from participants . Qualitative interviews were conducted with a sample of general practitioners ( GPs ) and community pharmacists to explore views on the role of the MO . RESULTS : Intervention group wastage was reduced from 18.1 % ( pre study ) to 1 % at 12 months . No data on wastage were collected for the control group after the pre study assessment . Sixty-one percent more prescription changes , including significant decreases in the number of prescribed drugs and dosages , were reported for the intervention group . GPs and pharmacists reported improvements in communication concerning medication-related dialog . CONCLUSIONS : This small exploratory study has shown that a pharmacy-prepared reusable MO provided visual , objective insights into medication wastage . This result ed in improved communication of drug needs and reduced wastage — the foundation for concordance This article reports a r and omized controlled trial design ed to test the effects of special packaging of antihypertensive medication on compliance and blood pressure control . One hundred eighty subjects who had exhibited elevated blood pressure greater than 90 mmHg in the two years prior to the study were recruited from patients receiving care at a community hospital-based family medicine practice . After completing preenrollment interviews and blood pressure measurements , subjects were r and omly assigned to receive their antihypertensive medications either in the usual vials or in special unit dose-reminder packaging . Follow-up interviews , pill counts , and blood pressure measurements were performed at three-month intervals . There were no statistically significant differences between the control and experimental groups with regard to age , sex , race , employment , education , marital status , insurance coverage , or blood pressure regimens . Prior to the intervention , the experimental group had slightly lower diastolic blood pressure and reported better compliance than the control group . Analyses performed on 165 subjects completing the first follow-up visit revealed no significant improvements in blood pressure control or compliance for patients receiving special medication packaging . While some patients found it easy to remember to take pills packaged using this format , they also found the packages somewhat more difficult and inconvenient to use . In contrast to previously reported work , this study did not demonstrate any significant improvement in compliance with special packaging of antihypertensive medications Adherence to prescribed antihypertensive agents is critical because control of elevated blood pressure is the single most important way to prevent stroke and other end organ damage . Unfortunately , nonadherence remains a significant problem . Previous interventions design ed to improve adherence have demonstrated only small benefits of strategies that target single facets such as underst and ing medication directions . The intervention described here is informed by prospect i ve memory theory and performance of older adults in laboratory-based paradigms and uses a comprehensive , multifaceted approach to improve adherence . It incorporates multiple strategies design ed to support key components of prospect i ve remembering involved in taking medication . The intervention is delivered by nurses in the home with an education control group for comparison . Differences between groups in overall adherence following the intervention and 6 months later will be tested . Systolic and diastolic blood pressure levels also will be examined between groups and as they relate to adherence . Intra-individual regression is planned to examine change in adherence over time and its predictors . Finally , we will examine the association between executive function/working memory and adherence , predicting that adherence will be related to executive/working memory in the control group but not in the intervention group Adherence to medications is an important issue in oncology due to the increasing number of anticancer agents , such as targeted therapies , formulated for oral dosing . A prospect i ve , crossover design was utilized in which patients on capecitabine were r and omly assigned to one of two packaging methods for one cycle , and then switched over to the alternate packaging method in the subsequent cycle . Twenty-five patients were accrued to this study . Adherence rates were similar when using the daily pill boxes ( 17/21 = 81 % ) and when using the conventional pill bottles ( 18/21 = 86 % ) . However , more patients were satisfied with the daily pill boxes ( 61 % versus 11 % , P = 0.027 ) , preferred the daily pill boxes ( 61 % versus 17 % , P = 0.061 ) , and thought the daily pill boxes were more helpful in reminding them to take their medications ( 50 % versus 11 % , P = 0.070 ) . In conclusion , this small pilot study did not demonstrate that the use of daily pill boxes improved patient adherence with capecitabine , but patient satisfaction and preference for this packaging method were greater than for the conventional pill bottles . Further exploration of this intervention in a larger study is warranted A r and omised trial was undertaken to discern the effect of pharmacy-based value-added utilities on prescription refill compliance with antihypertensive therapy and subsequent health care expenditures . The subjects were 304 Medicaid beneficiaries from the state of Florida , previously untreated for mild to moderate hypertension , prescribed 240 mg of calcium channel antagonist verapamil once daily and monitored regarding prescription refill compliance and health service utilisation for one year . Subjects provided informed consent and were r and omly assigned to one of four experimental groups : ( 1 ) the control cohort received st and ard pharmaceutical care with each dispensing of antihypertensive therapy , ( 2 ) the second cohort received st and ard pharmaceutical care and was mailed a medication-refill reminder ten days prior to each sequential refill date , ( 3 ) the third cohort received st and ard pharmaceutical care and was provided unit-of-use packaging with each prescription-refill request and ( 4 ) the fourth cohort received st and ard pharmaceutical care , mailed medication-refill reminders and unit-of-use packaging . Analysis of variance ( ANOVA ) procedures revealed that patients receiving mailed prescription-refill reminders , unit-of-use packaging or a combination of both interventions achieved a significant ( P < or = 0.05 ) increase in the Medication Possession Ratio ( MPR ) for antihypertensive therapy relative to controls . Receipt of both interventions result ed in a significant ( P < or = 0.05 ) improvement in the MPR for antihypertensive therapy relative to all other groups no significant difference was discerned between groups receiving either mailed prescription-refill reminders or unit-of-use packaging . ( ABSTRACT TRUNCATED AT 250 WORDS Inappropriate prescribing is particularly common in older patients and is associated with adverse drug events ( ADEs ) , hospitalization , and wasteful utilization of re sources . We r and omized 400 hospitalized patients aged ≥65 years to receive either the usual pharmaceutical care ( control ) or screening with STOPP/START criteria followed up with recommendations to their attending physicians ( intervention ) . The Medication Appropriateness Index ( MAI ) and Assessment of Underutilization ( AOU ) index were used to assess prescribing appropriateness , both at the time of discharge and for 6 months after discharge . Unnecessary polypharmacy , the use of drugs at incorrect doses , and potential drug – drug and drug – disease interactions were significantly lower in the intervention group at discharge ( absolute risk reduction 35.7 % , number needed to screen to yield improvement in MAI = 2.8 ( 95 % confidence interval 2.2–3.8 ) ) . Underutilization of clinical ly indicated medications was also reduced ( absolute risk reduction 21.2 % , number needed to screen to yield reduction in AOU = 4.7 ( 95 % confidence interval 3.4–7.5 ) ) . Significant improvements in prescribing appropriateness were sustained for 6 months after discharge A prospect i ve , controlled , crossover study on drug compliance was initiated in 22 elderly patients from a geriatric clinic . Half of the patients received their pills from a commercially prepared calendar mealtime blister-pak ; the remaining patients received their medication from st and ard pill bottles . At the end of three months the two groups were crossed over . Pill count and issuance of a new drug supply were done monthly to assess compliance . It was found that the average noncompliance index was significantly decreased ( 9.17 to 2.04 ) with the blister-pak packaging system . The relationship of age , Folstein mini-mental status , overcompliance , frequency of dosing interval , and living situation were also explored The impact of pill organizers on pill taking was determined in the Trial of Antioxidant Vitamins C and E ( TRACE ) Study , a factorial trial of vitamin C and vitamin E supplementation in 184 individuals . Participants were recruited in 1996 - 1997 and r and omized to one of two groups ( pill organizer or no organizer ) and to one of four supplement groups for 2 months . The pill count ( observed/expected X 100 % ) distribution was similar in the organizer and no organizer group for both vitamins . Mean differences in changes in serum vitamin levels between active and placebo groups did not differ by pill organizer use . The impact of pill organizers and blister packs was compared in another trial , the Vitamins , Teachers , and Longevity ( VITAL ) Study , in 297 individuals r and omized in 1993 - 1994 to receive study pills either in blister packs or in pill organizers and to take one of two supplements . Among those with lower adherence , the pill count distribution in the blister-pack group exceeded that in the organizer group . Mean differences in serum vitamin E levels between active and placebo groups did not differ by types of pill packaging . In summary , use of blister packs , but not pill organizers , improved adherence as measured by pill counts among those with lower adherence . Neither pill delivery system improved adherence as measured by serum vitamin levels OBJECTIVE To assess the impact of calendar blister pack ( CBP ) use on glycemic and blood pressure control . RESEARCH DESIGN AND METHODS We conducted an 8-month r and omized controlled double-blind study among diabetic patients with poor glucose control ( HbA1c > 9.0 % ) in an urban area of South Auckl and , New Zeal and , with a high proportion of Maori and Pacific Isl and s people . Subjects included 68 consecutive patients , of whom 50 % were prescribed three or more medications per day RESULTS HbA1c was reduced by 0.95+/-0.22 % in the CBP group and 0.15+/-0.25 % in the control group ( P = 0.026 ) . Diastolic blood pressure decreased 5.8+/-1.5 mm Hg in the CBP group and increased 0.1+/-1.9 mm Hg in the control group ( P = 0.0041 ) . Systolic blood pressure did not change significantly CONCLUSIONS CBPs should be considered among diabetic patients with poor glycemic control receiving multiple medications
Output:
| Three studies reported health care utilisation data but overall results are inconclusive .
No optimal dispensing or supply procedures were identified .
Organisation devices may help unintentional medication non-adherence and could improve health outcomes . |
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