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MS213400 | ***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 aim of the study was to estimate the influence of various laser therapy methods on knee joint pain and function in patients with knee osteoarthritis . MATERIAL AND METHODS 125 patients were r and omly assigned to 4 groups : • group I received one-wave laser irradiation ( wave length 810 nm , dose 8 J/point ) • group II received two-wave MLS laser irradiation ( power 1100 mW , frequency 2000 Hz , dose 12.4 J/point ) • group III received a similar regimen of two-wave MLS laser irradiation , but at a dose of 6.6 J per point • group IV was a placebo group where laser therapy procedures were simulated without actual irradiation . The effectiveness of the therapy was evaluated by means of Lequesne 's scale , a modified Laitinen question naire and a visual analogue scale ( VAS ) . Statistical analysis utilised non-parametric Wilcoxon 's and Mann-Whitney 's tests . Calculations were carried out with MedCalc v. 11.6.1.0 . RESULTS Statistically significant improvements in knee joint function and pain relief were seen in all groups ( I , II and III ) . When groups I , II and III were compared , the largest improvement was found in group II ( MLS laser , dose 12.4 J/point ) . The degrees of improvement in groups I and III were similar . CONCLUSIONS One-wave laser irradiation at a dose of 8 J per point and two-wave laser irradiation with doses of 12.4 J and 6.6 J per point significantly improved knee joint function and relieved knee pain in patients with osteoarthritis BACKGROUND AND OBJECTIVES A prospect i ve , double-blind , r and omized , and controlled trial was conducted in patients with knee osteoarthritis ( OA ) to evaluate the efficacy of infrared low-power Gallium-Arsenide ( Ga-As ) laser therapy ( LPLT ) and compared two different laser therapy regimes . STUDY DESIGN / MATERIAL S AND METHODS Ninety patients were r and omly assigned to three treatment groups by one of the nontreating authors by drawing 1 of 90 envelopes labeled ' A ' ( Group I : actual LPLT consisted of 5 minutes , 3 J total dose + exercise ; 30 patients ) , ' B ' ( Group II : actual LPLT consisted of 3 minutes , 2 J total dose + exercise ; 30 patients ) , and ' C ' ( Group III : placebo laser group + exercise ; 30 patients ) . All patients received a total of 10 treatments , and exercise therapy program was continued during study ( 14 weeks ) . Subjects , physician , and data analysts were unaware of the code for active or placebo laser until the data analysis was complete . All patients were evaluated with respect to pain , degree of active knee flexion , duration of morning stiffness , painless walking distance and duration , and the Western Ontario and Mc Master Universities Osteoarthritis Index ( WOMAC ) at week 0 , 6 , 10 , and 14 . RESULTS Statistically significant improvements were indicated in respect to all parameters such as pain , function , and quality of life ( QoL ) measures in the post-therapy period compared to pre-therapy in both active laser groups ( P < 0.01 ) . Improvements in all parameters of the Group I and in parameters , such as pain and WOMAC of the Group II , were more statistically significant when compared with placebo laser group ( P < 0.05 ) . CONCLUSIONS Our study demonstrated that applications of LPLT in different dose and duration have not affected results and both therapy regimes were a safe and effective method in treatment of knee OA Objectives : To estimate the effects of low level laser therapy in combination with a programme of exercises on pain , functionality , range of motion , muscular strength and quality of life in patients with osteoarthritis of the knee . Design : A r and omized double-blind placebo-controlled trial with sequential allocation of patients to different treatment groups . Setting : Special Rehabilitation Services . Subjects : Forty participants with knee osteoarthritis , 2–4 osteoarthritis degree , aged between 50 and 75 years and both genders . Intervention : Participants were r and omized into one of two groups : the laser group ( low level laser therapy dose of 3 J and exercises ) or placebo group ( placebo laser and exercises ) . Main measures : Pain was assessed using a visual analogue scale ( VAS ) , functionality using the Lequesne question naire , range of motion with a universal goniometer , muscular strength using a dynamometer , and activity using the Western Ontario and McMaster Universities Osteoarthritis ( WOMAC ) question naire at three time points : ( T1 ) baseline , ( T2 ) after the end of laser therapy ( three weeks ) and ( T3 ) the end of the exercises ( 11 weeks ) . Results : When comparing groups , significant differences in the activity were also found ( P = 0.03 ) . No other significant differences ( P > 0.05 ) were observed in other variables . In intragroup analysis , participants in the laser group had significant improvement , relative to baseline , on pain ( P = 0.001 ) , range of motion ( P = 0.01 ) , functionality ( P = 0.001 ) and activity ( P < 0.001 ) . No significant improvement was seen in the placebo group . Conclusion : Our findings suggest that low level laser therapy when associated with exercises is effective in yielding pain relief , function and activity on patients with osteoarthritis of the knees Objective The aim of this study was to evaluate the effects of an exercise training protocol and low-level laser therapy ( and the association of both treatments ) on musculoskeletal atrophy using an experimental model of knee osteoarthritis ( OA ) . Design Fifty male Wistar rats were r and omly divided into five groups : control group , knee OA control group , OA plus exercise training group , OA plus low-level laser therapy group , and OA plus exercise training associated with low-level laser therapy group . The exercise training and the laser irradiation started 4 wks after the surgery , 3 days per week for 8 wks . The exercise was performed at a speed of 16 m/min , 3 days per week , 50 mins per day , for 8 wks . Laser irradiation was applied at two points of the left knee joint ( medial and lateral ) , for 24 sessions . Results The results showed that both trained groups ( irradiated or not ) presented a significant increase in the muscle cross-sectional area and a decrease in muscle fiber density compared with the knee OA control group . Moreover , both trained and laser-irradiated groups demonstrated decreased muscle-specific ring-finger protein 1 and atrogin-1 immunoexpression . Conclusions These results suggest that exercise training and low-level laser therapy were effective in preventing musculoskeletal alterations related to atrophy caused by the degenerative process induced by knee OA Background Osteoarthritis is a chronic disease with a multifactor etiology involving changes in bone alignment , cartilage , and other structures necessary to joint stability . There is a need to investigate therapeutic re sources that combine different wavelengths as well as different light sources ( low-level laser therapy and light-emitting diode therapy ) in the same apparatus for the treatment of osteoarthritis . The aim of the proposed study is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program for individuals with osteoarthritis of the knee . Methods / Design A double-blind , controlled , r and omized clinical trial will be conducted involving patients with osteoarthritis of the knee . Evaluations will be performed using functional question naires before and after the treatment protocol s , in a reserved room with only the evaluator and participant present , and no time constraints placed on the answers or evaluations . The following functional tests will also be performed : stabilometry ( balance assessment ) , dynamometry ( muscle strength of gluteus medius and quadriceps ) , algometry ( pain threshold ) , fleximeter ( range of motion ) , timed up- and -go test ( functional mobility ) , and the functional reach test . The participants will then be allocated to three groups through a r and omization process using opaque envelopes : exercise program , exercise program + phototherapy , or exercise program + placebo phototherapy , all of which will last for eight weeks . Discussion The purpose of this r and omized clinical trial is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program for osteoarthritis of the knee . The study will support the practice based on evidence to the use of phototherapy in individuals with a diagnosis of osteoarthritis of the knee . Data will be published after the study is completed . Trial registration The protocol for this study has been su bmi tted to Clinical Trials , registration number NCT02102347 , on 29 March 2014 IMPORTANCE There is debate about benefits of acupuncture for knee pain . OBJECTIVE To determine the efficacy of laser and needle acupuncture for chronic knee pain . DESIGN , SETTING , AND PARTICIPANTS Zelen- design clinical trial ( r and omization occurred before informed consent ) , in Victoria , Australia ( February 2010-December 2012 ) . Community volunteers ( 282 patients aged ≥50 years with chronic knee pain ) were treated by family physician acupuncturists . INTERVENTIONS No acupuncture ( control group , n = 71 ) and needle ( n = 70 ) , laser ( n = 71 ) , and sham laser ( n = 70 ) acupuncture . Treatments were delivered for 12 weeks . Participants and acupuncturists were blinded to laser and sham laser acupuncture . Control participants were unaware of the trial . MAIN OUTCOMES AND MEASURES Primary outcomes were average knee pain ( numeric rating scale , 0 [ no pain ] to 10 [ worst pain possible ] ; minimal clinical ly important difference [ MCID ] , 1.8 units ) and physical function ( Western Ontario and McMaster Universities Osteoarthritis Index , 0 [ no difficulty ] to 68 [ extreme difficulty ] ; MCID , 6 units ) at 12 weeks . Secondary outcomes included other pain and function measures , quality of life , global change , and 1-year follow-up . Analyses were by intention-to-treat using multiple imputation for missing outcome data . RESULTS At 12 weeks and 1 year , 26 ( 9 % ) and 50 ( 18 % ) participants were lost to follow-up , respectively . Analyses showed neither needle nor laser acupuncture significantly improved pain ( mean difference ; -0.4 units ; 95 % CI , -1.2 to 0.4 , and -0.1 ; 95 % CI , -0.9 to 0.7 , respectively ) or function ( -1.7 ; 95 % CI , -6.1 to 2.6 , and 0.5 ; 95 % CI , -3.4 to 4.4 , respectively ) compared with sham at 12 weeks . Compared with control , needle and laser acupuncture result ed in modest improvements in pain ( -1.1 ; 95 % CI , -1.8 to -0.4 , and -0.8 ; 95 % CI , -1.5 to -0.1 , respectively ) at 12 weeks , but not at 1 year . Needle acupuncture result ed in modest improvement in function compared with control at 12 weeks ( -3.9 ; 95 % CI , -7.7 to -0.2 ) but was not significantly different from sham ( -1.7 ; 95 % CI , -6.1 to 2.6 ) and was not maintained at 1 year . There were no differences for most secondary outcomes and no serious adverse events . CONCLUSIONS AND RELEVANCE In patients older than 50 years with moderate or severe chronic knee pain , neither laser nor needle acupuncture conferred benefit over sham for pain or function . Our findings do not support acupuncture for these patients . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12609001001280 Inflammation of synovial membrane and degeneration of articular cartilage in osteoarthritis ( OA ) lead to major changes in joint space width ( JSW ) and biochemical components such as collagen-II telopeptide ( CTX-II ) and matrix metallo protineases ( MMP-3 , 8 , and 13 ) . Low-level laser therapy ( LLLT ) is thought to have an analgesic effect as well as biomodulatory effect on microcirculation and cartilage regeneration in animal studies . The objective of this study was to examine the analgesic and biochemical effect of LLLT in patients with knee osteoarthritis . Subjects ( n = 34 ) who fulfilled the selection criteria were r and omly divided into active group ( n = 17 ) and placebo group . Subjects in active group were irradiated laser with the frequency of 3 days per week for 4 weeks with the specific parameters on 8 different points on the joint at 1.5 J per point for 60 s for 8 points for a total dose of 12 J in a skin contact method . The placebo group was treated with the same probe with minimum emission of energy . Visual analog scale for pain intensity , joint space width , collagen-II telopeptide , and matrix metallo protinease-3 , 8 , and 13 was measured before treatment and at 4 and 8 weeks following treatment . Data are analyzed with mean values and st and ard deviation with p < 0.05 . Baseline values of all outcome measures show insignificant difference ( p > 0.05 ) in both groups which shows homogeneity . After 4- and 8-week treatment , active laser group shows more significant difference ( p
Output:
| Disability was also statistically significantly reduced by LLLT .
LLLT reduces pain and disability in KOA at 4 - 8 J with 785 - 860 nm wavelength and at 1 - 3 J with 904 nm wavelength per treatment spot . |
MS213401 | ***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 previous studies , a new IVF method of intracytoplasmic morphologically selected sperm injection ( IMSI ) was introduced , based on motile sperm organellar morphology examination ( MSOME ) . It was concluded that microinjection of morphologically selected sperm cells with strictly normal nucleus , defined by MSOME , improves IVF-ICSI outcome . The aim of the present study was to confirm this conclusion in new , enlarged study groups . Comparison between 80 couples , who underwent an IVF-IMSI trial , with matched couples , who underwent a st and ard IVF-ICSI procedure , confirmed that pregnancy rate following IVF-IMSI was significantly higher , and abortion rate significantly lower than in the routine IVF-ICSI ( 60.0 versus 25.0 % , and 14 versus 40 % respectively , P < or= 0.05 ) . Another comparison was performed between matched IMSI groups , where embryos were obtained from microinjection by spermatozoa with a morphologically normal nucleus ( ' best ' group , n = 70 ) and a ' second best ' group was selected , where embryos were obtained from microinjection of spermatozoa with minimal morphological impairment , since no other sperm cells were available . It was confirmed that microinjection by ' second best ' spermatozoa result in significantly lower pregnancy and delivery rates and significantly higher abortion rates than microinjection with ' best ' spermatozoa ( 25.7 versus 58.2 % , P < or= 0.01 ; 17.1 versus 52.8 % , P < or= 0.01 , and 33.3 versus 9.7 % , P < or= 0.02 respectively ) . The present study has strengthened previous conclusions STUDY QUESTION Does high-magnification sperm selection influence oocyte fertilization and further embryo development ? SUMMARY ANSWER The present study did not show a difference in oocyte fertilization rate , nor in embryo development between high-magnification intracytoplasmic morphologically selected sperm injection ( IMSI ) and conventional ICSI . WHAT IS KNOWN ALREADY The presence of nuclear vacuoles in sperm seems to influence embryo development and more specifically blastocyst formation . The use of high magnification for morphological sperm selection prior to ICSI has been associated with higher pregnancy rates and lower miscarriage rates . STUDY DESIGN , SIZE , DURATION A prospect i ve sibling-oocyte study was conducted , including 350 ICSI cycles to alleviate male infertility . Cycles were included from March 2010 to November 2011 . PARTICIPANTS / MATERIAL S , SETTING , METHODS On the day of treatment , a high-magnification sperm morphology was assessed on at least 200 spermatozoa . Primary endpoints were oocyte fertilization rate and embryo development . Because embryo transfers were not r and omized , the clinical outcome ( clinical pregnancy rate per transfer cycle ) was descriptive . However , the embryologist selecting the embryos for transfer was blinded for the sperm selection procedure . MAIN RESULTS AND THE ROLE OF CHANCE IMSI morphology was assessed in 330 semen sample s , result ing in the following distribution : 18.1 ± 14.8 % Grade I , 15.2 ± 10.3 % Grade II , 12.3 ± 9.1 % Grade III and 54.4 ± 23.2 % Grade IV . Oocyte fertilization rate was 79.1 and 77.3 % after IMSI and ICSI , respectively ( NS , paired t-test ) . Embryo development was similar in both treatment groups up to Day 5 of preimplantation development . Comparable numbers of IMSI-only ( n = 125 ) and ICSI-only ( n = 139 ) embryo transfers were performed . Clinical pregnancies with fetal heart beat were equally distributed over transfers with embryos from IMSI-only ( 34.4 % ) or ICSI-only treatment ( 36.7 % ) . LIMITATIONS , REASONS FOR CAUTION The clinical outcome remains descriptive . No firm conclusions could be drawn on cycle rank as a possible indication for IMSI . WIDER IMPLICATION S OF THE FINDINGS The prevalence of vacuoles in normal-shaped spermatozoa is as low as 27.5 % . A routine application of IMSI in unselected artificial reproductive technology patients can not be advocated . STUDY FUNDING /COMPETING INTEREST(S ) None BACKGROUND Our preceding studies have already demonstrated the advantage of intracytoplasmic morphologically selected sperm injection ( IMSI ) over the conventional IVF-ICSI procedure in terms of pregnancy rate . This study was undertaken to determine whether the increased pregnancy outcome was attributable to the preferred nuclear morphology of the selected spermatozoa , and not to the special sperm preparation technique modified by IMSI . METHODS Comparison between two matched IMSI groups , i.e. negative comprising 38 cycles , where no spermatozoa with intact nuclei were available for microinjection ; and positive , involving ovum microinjection by spermatozoa with strictly defined morphologically normal nuclei . RESULTS Implantation and pregnancy rates were significantly higher , and abortion rates significantly lower , in the positive group compared with the negative group ( 25.0+/-25.9 versus 5.9+/-12.9 % , F=15.8 , P < or = 0.01 ; 52.6 versus 18.4 % , chi2=9.7 , P < or = 0.01 ; and 10.0 versus 57.1 % , chi2=7.1 , P < or = 0.02 , respectively ) . CONCLUSIONS Implantation and pregnancy by ICSI is associated with morphological nuclear normalcy of sperm . Sperm with a morphologically abnormal nucleus usually have low fertility potential , but some with certain nuclear abnormalities may still be able to produce pregnancy following ICSI OBJECTIVE To examine the effect of sperm morphology on embryo development at the chromosomal level . DESIGN Prospect i ve study . SETTING Assisted fertilization center . PATIENT(S ) Couples who underwent IVF-PGS cycle , as a result of advanced maternal age , were r and omly allocated into two groups : intracytoplasmic sperm injection ( ICSI ; n = 60 ) or intracytoplasmic morphologically selected sperm injection ( IMSI ; n = 60 ) . INTERVENTION(S ) IVF in conjunction with preimplantation genetic screening ( PGS ) . MAIN OUTCOME MEASURE(S ) Sperm nuclear morphology at high-magnification ICSI and incidence of aneuploidy in derived embryo . RESULT ( S ) There was a significantly increased incidence for sex chromosome aneuploidy in ICSI embryos when compared with IMSI embryos ( 23.5 % vs. 15.0 % , respectively ) . High-magnification sperm selection was associated with a significantly lower risk of sex chromosome abnormalities ( odds ratio [ OR ] , 0.57 ; confidence interval [ CI ] , 0.37 - 0.90 ) . The incidence of chaotic embryos was also significantly higher with the ICSI procedure ( 27.5 % vs. 18.8 % ) , while the IMSI procedure was associated with a significantly lower risk of chaotic embryos ( OR , 0.64 ; CI , 0.43 - 0.96 ) . Moreover , the cycle cancellation rate was significantly higher in ICSI cycles ( 11.8 % vs. 2.5 % ) . High-magnification sperm selection was a significant predictor of the likelihood of cycle cancellation ( OR , 0.26 ; CI , 0.11 - 0.62 ) . CONCLUSION ( S ) Spermatozoa free of nuclear morphological malformations were found to be significantly associated with the lower incidence of aneuploidy in derived embryos , result ing in lower rates of cycle cancellation OBJECTIVE To verify whether microinjection into retrieved oocytes of motile spermatozoa with morphologically normal nuclei , strictly defined by high power light microscopy ( x > 6000 ) , improves the IVF/intracytoplasmic sperm injection ( ICSI ) pregnancy rate in couples with repeated ICSI failures . DESIGN Comparative prospect i ve study testing routine IVF/ICSI outcome parameters against those of modified ICSI based on morphological selection of spermatozoa with normal nuclei . SETTING Male factor fertility laboratory and IVF center . PATIENT(S ) Sixty-two couples , with at least two previous consequent pregnancy failed ICSI cycles , underwent a single ICSI trial preceded by morphological selection of spermatozoa with normal nuclei . Fifty of these couples were matched with couples who underwent a routine ICSI procedure at the same IVF center and exhibited the same number of previous ICSI failures . INTERVENTION(S ) St and ard ICSI and modified ICSI . MAIN OUTCOME MEASURE(S ) ICSI pregnancy rate . RESULT ( S ) The matching study revealed that pregnancy rate after modified ICSI was significantly higher than that of the routine ICSI procedure ( 66.0 % vs. 30.0 % ) . CONCLUSION ( S ) Microinjection into retrieved oocytes of selected spermatozoa with strictly defined morphologically normal nuclei improves significantly the incidence of pregnancy in couples with previous ICSI failures Background The purpose of this study was to compare laboratory and clinical outcomes of intracytoplasmic morphologically selected sperm injection ( IMSI ) and conventional intracytoplasmic sperm injection ( ICSI ) in couples with repeated implantation failures . Methods A total of 200 couples with at least two prior unsuccessful ICSI cycles were enrolled : 100 couples were su bmi tted to IMSI and 100 were su bmi tted to routine ICSI . For IMSI , spermatozoa were selected at 8400 × magnification using an inverted microscope equipped with Nomarski ( differential interference contrast ) optics . For conventional ICSI , spermatozoa were selected at 400 × magnification . Clinical outcomes were evaluated between the two groups . Results Study patients were comparable in age , number of treatment failures , aetiology of infertility , percentage of normal form assessed by MSOME ( motile sperm organelle morphology examination ) , semen parameters , total number of oocytes collected , number of mature oocytes collected , total number of embryos transferred and number of high- quality embryos transferred . No statistically significant differences between the two groups were observed with regard to rates of fertilisation , implantation and pregnancy/cycle . Although not statistically significant , rates of miscarriage ( IMSI:15.3 % vs ICSI:31.7 % ) , ongoing pregnancy ( IMSI:22 % vs ICSI:13 % ) and live births ( IMSI:21 % vs ICSI:12 % ) showed a trend towards better outcomes in the IMSI group . In addition , analysis of sub population s with or without male factor showed similar results . Conclusions Our results suggest that IMSI does not provide a significant improvement in clinical outcome compared to ICSI , at least in couples with repeated implantation failures after conventional ICSI . However , it should be noted that there were clear trends for lower miscarriage rates ( ≈50 % reduced ) and higher rates of ongoing pregnancy and live births ( both nearly doubled ) within the IMSI group . Further confirmation as well as r and omized large-scale trials are needed to confirm the beneficial effects of IMSI in couples with poor reproductive prognoses This prospect i ve r and omized study investigated whether intracytoplasmic sperm injection ( ICSI ) outcome can be improved with sperm pre selection under ×6000 magnification and intracytoplasmic morphologically selected sperm injection ( IMSI ) in patients with teratozoospermia and characterized embryo development and quality regarding sperm morphology and presence of head vacuoles . Couples with isolated teratozoospermia were divided into two groups : IMSI group ( n=52 ) and ICSI group ( n=70 ) and fertilization , blastocyst and clinical pregnancy rates were compared . Oocytes from 30 r and omly chosen patients from the IMSI group were injected with spermatozoa that had been previously classified under ×6000 magnification into four classes according to the number and size of vacuoles in the head and then cultured separately . Pronuclear morphology , embryo development and blastomere viability were estimated to investigate the influence of sperm morphology , especially vacuoles , on embryo developmental capacity . A significantly higher clinical pregnancy rate was achieved in the IMSI group compared with the ICSI group ( 48 % versus 24 % , P<0.05 ) . Fertilization with spermatozoa without head vacuoles yielded higher number of morphologically normal zygotes , higher blastocyst rate and smaller proportion of arrested embryos than spermatozoa with vacuoles and other head defects . IMSI is a method of choice in patients with teratozoospermia Background Sperm of poor quality can negatively affect embryo development to the blastocyst stage . The aim of this comparative prospect i ve r and omized study was to evaluate the role of an intracytoplasmic morphologically selected sperm injection ( IMSI ) in the same infertile couples included in the programme of intracytoplasmic sperm injection ( ICSI ) due to their indications of male infertility which had result ed in all arrested embryos following a prolonged 5-day culture in previous ICSI cycles . Methods Couples exhibiting poor semen quality and with all arrested embryos following a prolonged 5-day culture in previous ICSI cycles were divided into two groups : Group 1 : IMSI group ( n = 20 ) with IMSI performed in a current attempt and Group
Output:
| None of the included studies reported congenital abnormalities .
AUTHORS ' CONCLUSIONS Results from RCTs do not support the clinical use of IMSI .
There is no evidence of effect on live birth or miscarriage and the evidence that IMSI improves clinical pregnancy is of very low quality .
There is no indication that IMSI increases congenital abnormalities . |
MS213402 | ***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 Chronic hepatitis C virus ( HCV ) infection is more prevalent among patients who have chronic kidney disease than among those who do not have the disease . Patients with chronic kidney disease who also have HCV infection are at higher risk for progression to end‐stage renal disease than those who have chronic kidney disease without HCV infection . Patients with both HCV infection and advanced chronic kidney disease have limited treatment options . METHODS We conducted a multicenter , open‐label , phase 3 trial to evaluate the efficacy and safety of treatment with the combination of the NS3/4A protease inhibitor glecaprevir and the NS5A inhibitor pibrentasvir for 12 weeks in adults who had HCV genotype 1 , 2 , 3 , 4 , 5 , or 6 infection and also had compensated liver disease ( with or without cirrhosis ) with severe renal impairment , dependence on dialysis , or both . Patients had stage 4 or 5 chronic kidney disease and either had received no previous treatment for HCV infection or had received previous treatment with interferon or pegylated interferon , ribavirin , sofosbuvir , or a combination of these medications . The primary end point was a sustained virologic response 12 weeks after the end of treatment . RESULTS Among the 104 patients enrolled in the trial , 52 % had genotype 1 infection , 16 % had genotype 2 infection , 11 % had genotype 3 infection , 19 % had genotype 4 infection , and 2 % had genotype 5 or 6 infection . The sustained virologic response rate was 98 % ( 102 of 104 patients ; 95 % confidence interval , 95 to 100 ) . No patients had virologic failure during treatment , and no patients had a virologic relapse after the end of treatment . Adverse events that were reported in at least 10 % of the patients were pruritus , fatigue , and nausea . Serious adverse events were reported in 24 % of the patients . Four patients discontinued the trial treatment prematurely because of adverse events ; three of these patients had a sustained virologic response . CONCLUSIONS Treatment with glecaprevir and pibrentasvir for 12 weeks result ed in a high rate of sustained virologic response in patients with stage 4 or 5 chronic kidney disease and HCV infection . ( Funded by AbbVie ; Clinical Trials.gov number , NCT02651194 . BACKGROUND In our country , the national program for hepatitis C virus treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir was approved for patients with stage four of liver fibrosis and stage three associated with specific comorbidities . Our aim was to analyze the characteristics associated with the presence of adverse events in patients receiving this antiviral regimen , with ribavirin in cirrhotic patients . METHODS We prospect ively studied a cohort of adults with hepatitis C virus infection with Child A cirrhosis , treated for 12 weeks with ombitasvir/paritaprevir/ritonavir/dasabuvir and ribavirin , which have been followed in an infectious diseases tertiary-care hospital . RESULTS We included 137 adult patients diagnosed with compensated cirrhosis , hepatitis C virus genotype 1b infected , 82 ( 60 % ) previously treated . We recorded 201 adverse events in 98 ( 71.5 % ) patients , with a median number of events per patient of one . The intensity of adverse events was classified as mild , moderate and severe in 50 % , 36 % and 14 % of cases , respectively . Forty-five ( 22 % ) episodes required medical intervention . The most frequently reported adverse events were pruritus 34(35 % ) , asthenia 22(22 % ) and insomnia 15(15 % ) . The presence of severe adverse events was associated with the presence of comorbidities ( p = 0.01 , OR : 9.5 , 95 % CI : 1.2 - 74.3 ) and with the presence of associated medication ( p = 0.02 , OR : 3.9 , 95 % CI : 1.08 - 14.2 ) . At the end of current treatment , 136 ( 99.2 % ) patients had undetectable viral load . CONCLUSION We found a high number of adverse events , but most of them were mild or moderate and only one quarter of them required medical intervention . Only severe adverse events were associated with comorbidities and associated medication Well‐tolerated , ribavirin‐free , pangenotypic hepatitis C virus ( HCV ) treatments for transplant recipients remain a high priority . Once‐daily glecaprevir/pibrentasvir demonstrates high rates of sustained virologic response at 12 weeks posttreatment ( SVR12 ) across all major HCV genotypes ( GTs ) . This trial evaluated the safety and efficacy of glecaprevir/pibrentasvir for patients with chronic HCV GT1‐6 infection who had received a liver or kidney transplant . MAGELLAN‐2 was a phase 3 , open‐label trial conducted in patients who were ≥3 months posttransplant . Patients without cirrhosis who were HCV treatment‐naive ( GT1‐6 ) or treatment‐experienced ( GT1 , 2 , 4‐6 ; with interferon‐based therapy with or without sofosbuvir , or sofosbuvir plus ribavirin ) received glecaprevir/pibrentasvir ( 300/120 mg ) once daily for 12 weeks . The primary endpoint compared the percentage of patients receiving glecaprevir/pibrentasvir with SVR12 to a historic SVR12 rate based on the st and ard of care . Safety of glecaprevir/pibrentasvir was assessed . In total , 80 liver transplant and 20 kidney transplant patients participated in the trial . Most patients had no or minimal fibrosis ( 80 % had fibrosis scores F0‐F1 ) and were infected with HCV GT1 ( 57 % ) or GT3 ( 24 % ) . The overall SVR12 was 98 % ( n/N = 98/100 ; 95 % confidence interval , 95.3%–100 % ) , which exceeded the prespecified historic st and ard‐of‐care SVR12 threshold of 94 % . One patient experienced virologic failure . One patient discontinued because of an adverse event considered to be unrelated to treatment ; this patient achieved SVR12 . Adverse events were mostly mild in severity , and laboratory abnormalities were infrequent . Conclusion : Once‐daily glecaprevir/pibrentasvir for 12 weeks is a well‐tolerated and efficacious , ribavirin‐free treatment for patients with chronic HCV GT1‐6 infection who have received a liver or kidney transplant . ( Clinical Trials.gov NCT02692703 . ) ( Hepatology 2018 ; 00:000‐000 ) The OSIRIS study investigated efficacy and safety of simeprevir plus sofosbuvir for eight or 12 weeks in hepatitis C virus ( HCV ) genotype 4-infected patients with METAVIR F0-F4 fibrosis . Sixty-three patients ( 33 treatment-naïve and 30 peg-interferon/ribavirin (Peg-IFN/RBV)-experienced ) enrolled in a partly r and omized , open-label , multicentre , phase IIa study . Patients with F0-F3 fibrosis were r and omized ( 1:1 ) into two groups ( A1 and A2 ) , stratified according to treatment experience and METAVIR score , to receive either eight weeks ( Group A1 , n=20 ) or 12 weeks ( Group A2 , n=20 ) of treatment . Patients with compensated cirrhosis ( METAVIR F4 ) received 12 weeks of treatment ( Group B , n=23 ) . Treatment comprised simeprevir 150 mg and sofosbuvir 400 mg daily . The primary efficacy endpoint was sustained virologic response 12 weeks after planned end of treatment ( SVR12 ) . Safety and tolerability were assessed throughout . Overall , 92 % ( 95 % CI : 82 - 97 ) of patients achieved SVR12 ; 75 % ( 15/20 ) in Group A1 and 100 % in groups A2 and B. Patients who did not achieve SVR12 ( n=5 ) experienced viral relapse during the first 32 days following treatment and were all prior Peg-IFN/RBV null responders . The most commonly reported treatment-emergent adverse events ( TEAEs ) were asymptomatic lipase increase ( 14 % ) , pruritus ( 14 % ) , headache ( 13 % ) and hyperbilirubinaemia ( 11 % ) . No patients discontinued due to TEAEs . In conclusion , simeprevir plus sofosbuvir for 12 weeks achieved a 100 % SVR rate in HCV genotype 4-infected patients with or without compensated cirrhosis ( Clinical Trials.gov : NCT02278419 ) . The AE and laboratory profile were favourable and consistent with previous data for simeprevir plus sofosbuvir in eight- and 12-week regimens BACKGROUND Injection drug use is the primary mode of transmission for hepatitis C virus ( HCV ) , and treatment guidelines recommend treating HCV-infected people who use drugs ; however , concerns about adherence , effectiveness , and reinfection have impeded treatment uptake . METHODS Data were pooled from seven phase III trials that evaluated the efficacy and safety of 8 or 12 weeks of glecaprevir/pibrentasvir ( G/P ) in patients chronically infected with HCV genotypes 1 - 6 . Patients had compensated liver disease , with or without cirrhosis , and were HCV treatment-naïve or -experienced with interferon or pegylated interferon ± ribavirin , or sofosbuvir plus ribavirin ± pegylated interferon . Patients were grouped into recent drug users ( injection drug use ≤12 months before screening , positive urine drug screen [ UDS ] , and /or drug-related adverse event ) , former drug users ( > 12 months before screening and negative UDS ) , or non-drug users . Assessment s included sustained virologic response at 12 weeks posttreatment ( SVR12 ) , treatment adherence , and safety . RESULTS Among 1819 patients , 5 % , 34 % , and 61 % were recent , former , and non-drug users , respectively . Treatment adherence and completion were high ( ≥96 % ) regardless of drug use status . SVR12 was achieved by 93 % ( n/N = 91/98 ) , 97 % ( n/N = 591/610 ) , and > 99 % ( n/N = 1106/1111 ) of recent , former , and non-drug users , respectively ( intention-to-treat analysis ) . The overall rates of virologic failure were ≤1.5 % across all three sub population s , with no HCV reinfections among recent drug users . Drug-related serious adverse events and adverse events leading to treatment discontinuation were experienced by ≤1 % of patients . CONCLUSIONS G/P is a well-tolerated and efficacious pangenotypic regimen for chronic HCV-infected people with recent or active drug use Screening and treatment for hepatitis C virus ( HCV ) infection were not prioritised in psychiatric patients due to adverse neuropsychiatric effects of interferon therapy despite reports of high prevalence . However , with the safe new antiviral drugs , HCV eradication has become a reality in these patients . The aim of this study was to report HCV seroprevalence , risk factors and treatment model in an Australian cohort . This prospect i ve study involved patients admitted to four inpatient psychiatric units , from December 2016 to December 2017 . After pretest counselling and consent , HCV testing was done ; information on risk factors collected . A total of 260 patients ( 70 % male ) , median age 44 years ( IQR 24 ) , were studied . The HCV seroprevalence was 10.8 % ( 28/260 ) with 95 % CI 7 - 15 . Independent predictors of HCV positivity were injection drug use ( P < 0.001 , OR 44.05 , 95 % CI 7.9 - 245.5 ) , exposure to custodial stay ( P = 0.011 , OR 7.34 , 95 % CI 1.6 - 33.9 ) and age ( P = 0.011 , OR 1.09 , 95 % CI 1.02 - 1.16 ) . Eight of the 16 HCV RNA-positive patients were treated . Hepatitis nurses liaised with community mental health teams for treatment initiation and follow-up under supervision of hepatologists . Seven patients achieved sustained viral response , one achieved end of treatment response . The remaining eight patients were difficult to engage with . In conclusion , HCV prevalence was high in our cohort of psychiatric in patients . Although treatment uptake was achieved only in 50 % patients , it was successfully completed in all , with innovative models of care . These findings highlight the need to integrate HCV screening with treatment linkage in psychiatry practice
Output:
| Consistent with clinical trials , real-world evidence indicates that glecaprevir/pibrentasvir is a well-tolerated and highly effective pangenotypic treatment for a broad range of HCV-infected patients |
MS213403 | ***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: I SHALL discuss the combination of estimates of relative prevalence or incidence , commonly referred to as relative risk , obtained from retrospective 2 X 2 tables . Barnet Woolf ' described the method in 1954 and J. B. S. Haldane2 introduced some modifications shortly afterward in the Annals of Human Genetics . Figure 1 shows how retrospective case and control data may be classified . There are usually some background classes based on age , sex , race , occupation , and the like . Within each such class , individuals are further classified into a 2 X 2 table according to the presence or absence of the disease being studied and the presence or absence of a defined characteristic of focal interest . For any single 2 X 2 table , Cornfield3 has shown a simple way to estimate the risk of disease among those wvith the characteristic , relative to the risk of disease among those without the characteristic . This is done , as illustrated below Figure 1 , by taking the ratio of diagonal products of the cell frequencies . This is a maximum likelihood estimate of the relative risk of disease in the parent population , provided that it is assumed that the cases and controls have been selected at r and om and that cases comprise a negligible portion of the population . It is also possible to obtain a combined , unconditioned , maximum likelihood estimate of relative risk based on all of the 2 X 2 tables . However , the method is time-consuming , involving the iterative solution of sets of quadratic equations . Unless such a method is programed for the computer , I feel that the less tedious procedure to be described is adequate for most practical purpose s. Strictly speaking , the maximum likelihood estimate just described has infinite bias and it is positively skewed . To help remedy these defects , the number , 1/2 , is added to each cell frequency before obtaining the ratio of diagonal products ; furthermore , the natural logarithm of this ratio is taken . The result ing value is an estimate of natural log relative risk . Woolf pointed out that the logarithmic transformation tends to remove skew and Haldane showed that of all possible numbers which might be added to or subtracted from the cell frequencies , 1/2 is the number which reduces the bias of the estimate to a minimum . This estimate of log relative risk is shown in the first column of Figure 2 . The estimated Background The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports , including many studies identified by their authors as r and omized controlled trials . It has been noticed that these reports mostly present positive results , and their quality and authenticity have consequently been called into question . We investigated the adequacy of r and omization of clinical trials published in recent years in China to determine how many of them met acceptable st and ards for allocating participants to treatment groups . Methods The China National Knowledge Infrastructure electronic data base was search ed for reports of r and omized controlled trials on 20 common diseases published from January 1994 to June 2005 . From this sample , a subset of trials that appeared to have used r and omization methods was selected . Twenty-one investigators trained in the relevant knowledge , communication skills and quality control issues interviewed the original authors of these trials about the participant r and omization methods and related quality -control features of their trials . Results From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure data base , we found 3137 apparent r and omized controlled trials . Of these , 1452 were studies of conventional medicine ( published in 411 journals ) and 1685 were studies of traditional Chinese medicine ( published in 352 journals ) . Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for r and omization and could on those grounds be deemed authentic r and omized controlled trials ( 6.8 % , 95 % confidence interval 5.9–7.7 ) . There was no statistically significant difference in the rate of authenticity between r and omized controlled trials of traditional interventions and those of conventional interventions . R and omized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals ( relative risk 1.58 , 95 % confidence interval 1.18–2.13 , and relative risk 14.42 , 95 % confidence interval 9.40–22.10 , respectively ) . The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals ( relative risk 9.32 , 95 % confidence interval 5.83–14.89 ) . All r and omized controlled trials of pre-market drug clinical trial were authentic by our criteria . Of the trials conducted at university-affiliated hospitals , 56.3 % were authentic ( 95 % confidence interval 32.0–81.0 ) . Conclusion Most reports of r and omized controlled trials published in some Chinese journals lacked an adequate description of r and omization . Similarly , most so called ' r and omized controlled trials ' were not real r and omized controlled trials owing toa lack of adequate underst and ing on the part of the authors of rigorous clinical trial design . All r and omized controlled trials of pre-market drug clinical trial included in this research were authentic . R and omized controlled trials conducted by authors in high level hospitals , especially in hospitals affiliated to medical universities had a higher rate of authenticity . That so many non-r and omized controlled trials were published as r and omized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed OBJECTIVE To determine whether clinical trials originating in certain countries always have positive results . DATA SOURCES Abstract s of trials from Medline ( January 1966-June 1995 ) . STUDY SELECTION Two separate studies were conducted . The first included trials in which the clinical outcome of a group of subjects receiving acupuncture was compared to that of a group receiving placebo , no treatment , or a nonacupuncture intervention . In the second study , r and omized or controlled trials of interventions other than acupuncture that were published in China , Japan , Russia/USSR , or Taiwan were compared to those published in Engl and . DATA EXTRACTION Blinded review ers determined inclusion and outcome and separately classified each trial by country of origin . DATA SYNTHESIS In the study of acupuncture trials , 252 of 1085 abstract s met the inclusion criteria . Research conducted in certain countries was uniformly favorable to acupuncture ; all trials originating in China , Japan , Hong Kong , and Taiwan were positive , as were 10 out of 11 of those published in Russia/USSR . In studies that examined interventions other than acupuncture , 405 of 1100 abstract s met the inclusion criteria . Of trials published in Engl and , 75 % gave the test treatment as superior to control . The results for China , Japan , Russia/USSR , and Taiwan were 99 % , 89 % , 97 % , and 95 % , respectively . No trial published in China or Russia/USSR found a test treatment to be ineffective . CONCLUSIONS Some countries publish unusually high proportions of positive results . Publication bias is a possible explanation . Research ers undertaking systematic review s should consider carefully how to manage data from these countries BACKGROUND We conducted a r and omized study to determine whether any of three chemotherapy regimens was superior to cisplatin and paclitaxel in patients with advanced non-small-cell lung cancer . METHODS A total of 1207 patients with advanced non-small-cell lung cancer were r and omly assigned to a reference regimen of cisplatin and paclitaxel or to one of three experimental regimens : cisplatin and gemcitabine , cisplatin and docetaxel , or carboplatin and paclitaxel . RESULTS The response rate for all 1155 eligible patients was 19 percent , with a median survival of 7.9 months ( 95 percent confidence interval , 7.3 to 8.5 ) , a 1-year survival rate of 33 percent ( 95 percent confidence interval , 30 to 36 percent ) , and a 2-year survival rate of 11 percent ( 95 percent confidence interval , 8 to 12 percent ) . The response rate and survival did not differ significantly between patients assigned to receive cisplatin and paclitaxel and those assigned to receive any of the three experimental regimens . Treatment with cisplatin and gemcitabine was associated with a significantly longer time to the progression of disease than was treatment with cisplatin and paclitaxel but was more likely to cause grade 3 , 4 , or 5 renal toxicity ( in 9 percent of patients , vs. 3 percent of those treated with cisplatin plus paclitaxel ) . Patients with a performance status of 2 had a significantly lower rate of survival than did those with a performance status of 0 or 1 . CONCLUSIONS None of four chemotherapy regimens offered a significant advantage over the others in the treatment of advanced non-small-cell lung cancer PURPOSE This r and omized trial was design ed to determine whether paclitaxel plus carboplatin ( PC ) offered a survival advantage over vinorelbine plus cisplatin ( VC ) for patients with advanced non -- small-cell lung cancer . Secondary objectives were to compare toxicity , tolerability , quality of life ( QOL ) , and re source utilization . PATIENTS AND METHODS Two hundred two patients received VC ( vinorelbine 25 mg/m(2)/wk and cisplatin 100 mg/m(2)/d , day 1 every 28 days ) and 206 patients received PC ( paclitaxel 225 mg/m(2 ) over 3 hours with carboplatin area under the curve of 6 , day 1 every 21 days ) . Patients completed QOL question naires at baseline , 13 weeks , and 25 weeks . Re source utilization forms were completed at five time points through 24 months . RESULTS Patient characteristics were similar between the groups . The objective response rate was 28 % in the VC arm and 25 % in the PC arm . Median survival was 8 months in both arms , with 1-year survival rates of 36 % and 38 % , respectively . Grade 3 and 4 leukopenia ( P = .002 ) and neutropenia ( P = .008 ) occurred more frequently on the VC arm . Grade 3 nausea and vomiting were higher on the VC arm ( P = .001 , P = .007 ) , and grade 3 peripheral neuropathy was higher on the PC arm ( P < .001 ) . More patients on the VC arm discontinued therapy because of toxicity ( P = .001 ) . No difference in QOL was observed . Overall costs on the PC arm were higher than on the VC arm because of drug costs . CONCLUSION PC is equally efficacious as VC for the treatment of advanced non -- small-cell lung cancer . PC is less toxic and better tolerated but more expensive than VC . New treatment strategies should be pursued OBJECTIVE To observe the clinical therapeutic effect and mechanism of Yiqi Yangyin Jiedu Decoction ( YYJD , a Chinese herbal recipe for strengthening qi , nourishing yin and removing toxic substance , consisting of milkvetch root 30 g , glehnia root 30 g , asparagus root 15 g , lilyturf root 15 g , grossy privet fruit 12 g , spikemoss herb 30 g , Chinese sage herb 30 g , manyleaf paris rhizome 30 g , etc . ) in treating patients with advanced nonsmall cell lung cancer ( NSCLC ) . METHODS Sixty patients with advanced lung cancer of qi-yin deficiency syndrome were r and omized into three groups : the TCM group ( A ) treated with YYJD , the chemotherapy group ( B ) treated by chemotherapy with NP or GP protocol , and the combined treated group ( C ) treated with YYJD and chemotherapy in combination . The efficacy was evaluated after two cycles of treatment . RESULTS The total effective rate for alleviating qi-yin deficiency syndrome in group A was 80 % , significantly higher than that in Group C and B ( 35 % and 20 % , P < 0.01 ) respectively . The KPS increasing and stabilizing rate in Group A and C was 90 % and 85 % respectively , significantly higher than that in Group B ( 75 % ) , and difference between A and B was significant ( P < 0.05 ) . In Group C after treatment , CD(3)+ showed a rising trend ( P = 0.05 ) , different to that in Group A and B ( P < 0.05 and P < 0.01 ) ; CD(4)+ significantly increased ( P < 0.05 ) and CD(4)+/CD(8)+ ratio showed increasing trend ( P = 0.06 ) , while in Group B both were decreased significantly , showed significantly difference ( P < 0.05 ) . CD(8)+ CD(28)+ significantly increased after treatment in Group A and C ( P < 0.01 and P < 0.05 ) , but showed decreasing trend ( P = 0.06 ) in Group B , significant difference was shown between B and C ( P < 0.05 ) . CONCLUSION YYJD can ameliorate the qi-yin deficiency syndrome evidently in advance lung cancer patients ; improve their quality of life , the mechanism might be by way of enhancing T-lymphocyte activity and killer T-cell function , to elevate the T-cell mediated immunity in a round way OBJECTIVE To observe the regulatory effect of Jianpi Wenshen Recipe ( JPWS ) , a Chinese herbal preparation for strengthening Pi and warming Shen , combined with chemotherapy on the level of estradiol ( E2 ) in patients with mid-late non-small cell lung cancer ( NSCLC ) , and to analyse the relationship between the changes of estradiol and tumor size . METHODS Fifty-one NSCLC patients were r and omized into three groups : 1
Output:
| We found a large treatment effect of adding astragalus-based herbal treatment to st and ard chemotherapy regimens . |
MS213404 | ***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 purpose of the present study was to compare the success of and surgical differences between 1- and 2-stage sinus inlay bone grafts and implants after 1 year in function . The individual risk for implant failure in grafted areas among 1-stage patients was about twice the risk in 2-stage patients ( odds ratio 2.3 , CI 0.6 ; 8.5 ) . The risk for implant failure in non-grafted areas was significantly lower ( P < .05 ) than in grafted areas , regardless of the technique used . Forty edentulous patients , selected according to strict inclusion criteria from consecutive referrals , were allocated to one or other of the 2 sinus-inlay procedures . Twenty patients received bone blocks fixed by implants to the residual alveolar crest in a 1-stage procedure ( group 1 ) . In another 20 patients , particulated bone was condensed against the antral floor and left to heal for 6 months before implants were placed ( group 2 ) . An almost equal number of implants was placed in the patients of each group , 76 in the 1-stage procedure and 74 in the 2-stage procedure . Additionally , 72 and 66 implants were placed in the anterior non-grafted regions of group 1 and group 2 patients , respectively . After 1 year in function , a total of 20 implants failed in 1-stage patients , versus 11 in 2-stage patients . Sixteen and 8 implants , respectively , of these were placed in grafted bone . All but one 1-stage patient received the planned fixed prosthetic restorations , but 1 restoration was re design ed after the first year in function because of a functionally unacceptable prosthetic design . At the 1-year follow-up , one 2-stage patient lost her prosthesis as the result of multiple implant failures . Bruxism and postoperative infections were the only parameters that could be related to implant failure , however , depending on the statistical method used 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 The aim of the present clinical study was to test whether or not the addition of recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) to a xenogenic bone substitute mineral ( Bio-Oss ) will improve guided bone regeneration therapy regarding bone volume , density and maturation . In 11 partially edentulous patients , 34 Brånemark implants were placed at two different sites in the same jaw ( five maxillae , six m and ibles ) requiring lateral ridge augmentation . The bone defects were r and omly assigned to test and control treatments : the test and the control defects were both augmented with the xenogenic bone substitute and a resorbable collagen membrane ( Bio-Gide ) . At the test sites , the xenogenic bone substitute mineral was coated with rhBMP-2 in a lyophilization process . Following implant insertion ( baseline ) , the peri-implant bone defect height was measured from the implant shoulder to the first implant-bone contact . After an average healing period of 6 months ( SD 0.17 , range 5.7 - 6.2 ) , the residual defects were again measured and trephine burs were used to take 22 bone biopsies from the augmented regions . The healing period was uneventful except for one implant site that showed a wound dehiscence , which spontaneously closed after 4 weeks . Later at reentry , all implants were stable . At baseline , the mean defect height was 7.0 mm ( SD 2.67 , range 3 - 12 mm ) at test and 5.8 mm ( SD 1.81 , range 3 - 8 mm ) at control sites . At reentry , the mean defect height decreased to 0.2 mm ( SD 0.35 , range 0 - 1 mm ) at test sites ( corresponding to 96 % vertical defect fill ) and to 0.4 mm ( SD 0.66 , range 0 - 2 mm ) at the control site ( vertical defect fill of 91 % ) . Reduction in defect height from baseline to reentry for both test and control sites was statistically significant ( Wilcoxon P<0.01 ) . Histomorphometric analysis showed an average area density of 37 % ( SD 11.2 , range 23 - 51 % ) newly formed bone at test sites and 30 % ( SD 8.9 , range 18 - 43 % ) at control sites . The fraction of mineralized bone identified as mature lamellar bone amounted to 76 % ( SD 14.4 , range 47.8 - 94 % ) at test compared to 56 % ( SD 18.3 , range 31.6 - 91.4 % ) at control sites ( paired t-test P<0.05 ) . At BMP-treated sites 57 % ( SD 16.2 , range 29 - 81 % ) and at control sites 30 % ( SD 22.6 , range 0 - 66 % ) of the surface of the bone substitute particles were in direct contact with newly formed bone ( paired t-test P<0.05 ) . It is concluded that the combination of the xenogenic bone substitute mineral with rhBMP-2 can enhance the maturation process of bone regeneration and can increase the graft to bone contact in humans . rhBMP-2 has the potential to predictably improve and accelerate guided bone regeneration therapy The purpose of this clinical investigation was to compare the new resorbable collagen membrane , Bio-Gide , to the conventional exp and ed polytetrafluoroethylene material ( Gore-Tex ) for guided bone regeneration in situations involving exposed implant surfaces . Over a 2-year period , 25 split-mouth patients were treated r and omly : one defect site was treated with Bio-Gide and the other defect site with Gore-Tex ; all 84 defects were filled with Bio-Oss and covered with the respective membrane . The defect types , their dimensions , and their morphology were measured in detail initially and at re-entry to allow for calculation of the exposed implant surface . Changes in defect surface for both types of membranes were statistically significant ( P < .0001 ) ; however , no statistical significance ( P > .94 ) could be detected between the two membranes . The mean average percentage of bone fill was 92 % for Bio-Gide and 78 % for Gore-Tex sites . In the latter group , 44 % wound dehiscences and /or premature membrane removal occurred . The resorbable membrane , Bio-Gide , in combination with a bone graft , can be a useful alternative to the well-established exp and ed polytetrafluoroethylene membranes OBJECTIVES Graft insertion can effectively enhance the regeneration of debilitated bone . The effects of an alloplastic bone-replacing material , beta-tricalcium phosphate ( Cerasorb ) , and of autogenous bone graft were compared . MATERIAL S AND METHODS In 17 edentulous patients , the maxillary sinus floor was extremely atrophied to such an extent that implant placement was impossible . The Schneiderian membrane was surgically elevated bilaterally by insertion of Cerasorb ( experimental side ) and autogenous bone graft ( control side ) . After surgery , the recovery was followed clinical ly and radiologically . After 6 months , 68 bone cylinders were excised from the grafted areas and implants were inserted into their places . The bone sample s were embedded into resin , and the osteointegration of the grafts was studied histologically . Trabecular bone volume ( TBV ) and trabecular bone pattern factor ( TBPf ) were quantified by histomorphometry . RESULTS Cerasorb proved to be an effective bone-replacing material with osteoconductivity ; it was capable of gradual disintegration , thereby providing space for the regenerating bone . The new bone density was not significantly different on the experimental and control sides ( 32.4+/-10.9 % and 34.7+/-11.9 % , respectively ) . However , the graft biodegradation was significantly slower on the experimental side than the control side . The TBPf value was lower on the control side than on the experimental side ( -0.53+/-1.7 and -0.11+/-1.4 mm(-1 ) , respectively ) , but this difference was not significant . CONCLUSIONS Six months after insertion of the grafts , the bone of the augmented sinus floor was strong and suitable for anchorage of dental implants , irrespective of whether autogenous bone or Cerasorb particles had been applied Two techniques of ridge augmentation using onlay bone graft alone or associated with a non-resorbable membrane have been previously described . This prospect i ve , r and omized study compared these two techniques at 6 months , in terms of bone gain , resorption and quality obtained at edentulous sites . Osseous measurements were taken using stents , callipers and CT-scans . Membrane exposure occurred at one site , 4 weeks after placement . Endosseous implants were successfully placed at all grafted sites . The mean graft thickness for all subjects was 4.7 mm ( range : 2.3 - 6.2 mm ) . Overall mean resorption was 1.5 mm ( range : 0 - 4.6 mm ) whereas overall mean width gain was 3.2 mm ( range : 0.8 - 6.2 mm ) . Six months following surgery , the membrane group experienced significantly less bone resorption than the graft alone group ( P<0.01 ) . Width augmentation did not differ significantly between the two groups . In conclusion , combining a membrane with an onlay graft demonstrates less bone resorption with a minimal risk of complications . Longer follow-up is needed to confirm the benefits of using a non-resorbable membrane Lack of bone in localized areas of the jaws frequently poses a problem when placing oral implants . In this clinical study , we have tested an osteopromotive membrane technique for its ability to create bone over buccal fenestrations after fixture installation in the maxilla . 7 patients were selected by the use of CT-scan . Criteria for patient selection were that the alveolar crest should have a vertical height > 13 mm and a facial-palatal concavity , where exposure at the central portion of the fixture could be anticipated . One fenestration , r and omly chosen , in each patient was covered with an e-PTFE ( exp and ed polytetrafluoroethylene ) ( Gore-Tex GTAM ) membrane . Contralateral fenestrations served as controls ( without the placement of a membrane ) . The amount of newly formed bone was calculated by photometric assessment s. The results showed that the fixture fenestrations , treated with the membrane technique , demonstrated a significantly ( p<0.005 ) higher amount of new bone formation compared to the controls , where little or no improvement had taken place at the fenestrations . The study conclusively shows that the membrane technique is a reconstructive technique , able to create new bone at localized bone fenestrations at titanium fixtures . Additionally , the study also demonstrates that the periosteum alone , in adult humans , is not capable of generating new bone at exposed titanium implants PURPOSE The aim of this r and omized study was to evaluate and compare the long-term success rates of cylindric , screw-type titanium implants with a larger diameter ( 5.9 mm ) that were placed in fresh extraction sockets in association with resorbable bone substitutes or a resorbable membrane . MATERIAL S AND METHODS Eighty-three partially edentulous adult patients , selected from among those treated in 1997 and 1998 at the San Raffaele Institute in whom 1 or more implants had been placed into fresh posterior m and ibular or maxillary sockets , were included in the study . A total of 111 implants were placed , 36 in m and ibles and 75 in maxillae . Fifty-six implants were placed in combination with resorbable hydroxyapatite ( HA group ) and 55 with a resorbable membrane ( MR group ) . Intraoral radiographs and follow-up examinations , including verification of implant stability via the Periotest , were carried out at second-stage surgery 3 , 6 , 9 , and 12 months later ; and then annually up to 4 years after placement of the definitive restoration . The radiographic examination was conducted by means of a st and ardized procedure to verify osseointegration . RESULTS There was 100 % attendance at the follow-up examination after 4 years . At second-stage surgery , which was performed after 4 to 6 months ' healing time , none of the implants showed any signs of mobility , peri-implantitis , or bone loss . Two implants failed in the MR group ,
Output:
| CONCLUSIONS Major bone grafting procedures of extremely resorbed m and ibles may not be justified .
Bone substitutes may replace autogenous bone for sinus lift procedures of extremely atrophic sinuses .
Both guided bone regeneration procedures and distraction osteogenesis can be used to augment bone vertically , but it is unclear which is the most efficient .
It is unclear whether augmentation procedures are needed at immediate single implants placed in fresh extraction sockets ; however , sites treated with barrier + Bio-Oss showed a higher position of the gingival margin than sites treated with barriers alone .
More bone was regenerated around fenestrated implants with nonresorbable barriers than without barriers ; however , it remains unclear whether such bone is of benefit to the patient .
Bone morphogenetic proteins may enhance bone formation around implants grafted with Bio-Oss , but there was no reliable evidence supporting the efficacy of other active agents , such as platelet-rich plasma , in conjunction with implant treatment |
MS213405 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: AIM To investigate the feasibility and reproducibility of real-time freeh and ultrasound elastography ( RTE ) of the normal Achilles tendon and to describe its elastographic appearances . MATERIAL S AND METHODS Fifty normal Achilles tendons were prospect ively examined using RTE performed by tissue compression using the h and -held transducer . The information was colour-coded ( red = soft , green = medium , blue = hard ) and superimposed on the B-mode image . Each tendon was examined three times transversely and longitudinally by two radiologists and the ratio between tendon and retro-Achilles fat strain ( strain index ) was calculated . The reproducibility of the elastograms was assessed qualitatively and quantitatively using the strain index inter and intra observer variation coefficient ( intra/inter-CV and intra/inter-CC , respectively ) . RESULTS All tendons were clearly visualized on the elastograms . Nineteen tendons ( 19/50 , 38 % ) appeared homogeneously green/blue ( type 1 ) . Thirty-one tendons ( 31/50 , 62 % ) appeared green with longitudinal red stripes ( type 2 ) . The intra- and inter-CC values of the strain index were lower for the transverse plane than for the longitudinal plane ( 0.43 , 0.45 , 0.41 and 0.78 , 0.66 , 0.51 , respectively ) . The intra-CV and inter-CV values were higher for the transverse than for the longitudinal plane measurements ( 39 % , 37 % , 30 % and 30.50 % , 30.10 % , 29.60 % , respectively ) . CONCLUSION RTE of the normal Achilles tendon is a feasible method . The reproducibility of the strain index is good and higher for longitudinal elastograms . Qualitative assessment enables the discrimination of two distinct elastographic patterns . Further studies are required to assess the clinical value of this method PURPOSE To investigate the differences in viscoelastic properties between normal and pathologic Achilles tendons ( ATs ) by using real-time shear-wave elastography ( SWE ) . MATERIAL S AND METHODS The institutional review board approved this study , and written informed consent was obtained from 25 symptomatic patients and 80 volunteers . One hundred eighty ultrasonographic ( US ) and SWE studies of ATs without tendonopathy and 30 studies of the middle portion of the AT in patients with tendonopathy were assessed prospect ively . Each study included data sets acquired at B-mode US ( tendon morphology and cross-sectional area ) and SWE ( axial and sagittal mean velocity and relative anisotropic coefficient ) for two passively mobilized ankle positions . The presence of AT tears at B-mode US and signal-void areas at SWE were noted . RESULTS Significantly lower mean velocity was shown in tendons with tendonopathy than in normal tendons in the relaxed position at axial SWE ( P < .001 ) and in the stretched position at sagittal ( P < .001 ) and axial ( P = .0026 ) SWE . Tendon softening was a sign of tendonopathy in relaxed ATs when the mean velocity was less than or equal to 4.06 m · sec(-1 ) at axial SWE ( sensitivity , 54.2 % ; 95 % confidence interval [ CI ] : 32.8 , 74.4 ; specificity , 91.5 % ; 95 % CI : 86.3 , 95.1 ) and less than or equal to 5.70 m · sec(-1 ) at sagittal SWE ( sensitivity , 41.7 % ; 95 % CI : 22.1 , 63.3 ; specificity , 81.8 % ; 95 % CI : 75.3 , 87.2 ) and in stretched ATs , when the mean velocity was less than or equal to 4.86 m · sec(-1 ) at axial SWE ( sensitivity , 66.7 % ; 95 % CI : 44.7 , 84.3 ; specificity , 75.6 % ; 95 % CI : 68.5 , 81.7 ) and less than or equal to 14.58 m · sec(-1 ) at sagittal SWE ( sensitivity , 58.3 % ; 95 % CI : 36.7 , 77.9 ; specificity , 83.5 % ; 95 % CI : 77.2 , 88.7 ) . Anisotropic results were not significantly different between normal and pathologic ATs . Six of six ( 100 % ) partial-thickness tears appeared as signal-void areas at SWE . CONCLUSION Whether the AT was relaxed or stretched , SWE helped to confirm and quantify pathologic tendon softening in patients with tendonopathy in the midportion of the AT and did not reveal modifications of viscoelastic anisotropy in the tendon . Tendon softening assessed by using SWE appeared to be highly specific , but sensitivity was relatively low Objective The aim of this study was to investigate whether ultrasound elastography can demonstrate the outcome of the treatment in comparison with gray-scale imaging . Methods Sixteen patients ( mean age , 46.9 years ) with plantar fasciitis were prospect ively enrolled after unsuccessful conservative treatment . Individuals grade d their heel pain on a 100-mm visual analogue scale ( VAS ) and underwent gray-scale ultrasonography and sonoelastography . Collagen was injected in the heels . Fascial thickness and hypoechogenicity , perifascial edema , and plantar fascial elasticity were evaluated . Follow-up sonoelastography and VAS grading were done 3 months after the injection . Statistical analyses were performed by the paired t test and the Fisher exact test . A P < 0.05 was considered statistically significant . Results Mean plantar fascial thickness showed insignificant decrease on follow-up ( from 4.30 [ 1.37 ] to 4.23 [ 1.15 ] mm , P = 0.662 ) . Fascial hypoechogenicity and perifascial edema did not change significantly after treatment . The mean strain ratio of the plantar fascia was significantly increased ( from 0.71 [ 0.24 ] to 1.66 [ 0.72 ] , P = 0.001 ) . Softening of the plantar fascia decreased significantly after injection ( from 12 to 3 ft , P = 0.004 ) . Twelve ( 75 % ) of 16 patients showed significant VAS improvement at the follow-up . Conclusions Sonoelastography revealed a hardening of the plantar fascia after collagen injection treatment and could aid in monitoring the improvement of the symptoms of plantar fasciitis , in cases where gray-scale imaging is inconclusive Purpose To investigate the feasibility of real-time sonoelastography in the assessment of the mechanical tendon properties in small unilateral supraspinatus tears , to describe the sonoelastographic properties of the torn supraspinatus tendons and to correlate real-time sonoelastography findings with clinical results and demographic data . Methods All the patients presenting for a unilateral rotator cuff tear were prospect ively scrutinized . Clinical evaluation included complete physical examination , VAS , Quick DASH , Constant – Murley score , Simple Shoulder Test , ASES score and UCLA score . Radiological evaluation was performed with conventional ultrasounds and real-time sonoelastography ; this is a noninvasive method that uses ultrasounds to evaluate the mechanical properties of tissues , reflecting their quality , that can be semi-quantitatively estimated using the strain index . During the enrolment period , 92 patients were scrutinized , and 50 were included in the study . Results A negative correlation between strain index and VAS for pain , a strong positive correlation between strain index and Constant – Murley score and ASES score were found . Comparable results were observed in male and female patients , but in males , we found a strong positive correlation also for Simple Shoulder Test and UCLA score . Conclusions Real-time sonoelastography was a feasible method applicable in the assessment of tendon quality in small supraspinatus tears , and its findings correlated with the clinical results of the patients . In day-by-day clinical practice , this information is very important because quality of tendons is one of the most important prognostic factors for surgeons performing rotator cuff repair . Level of evidence III Abstract Purpose To evaluate the sonoelastographic features of Achilles tendon healing after percutaneous treatment using real-time sonoelastography , a new tool able to quantify deformation in biological tissues . Methods Patients with atraumatic Achilles tendon ruptures , treated with a percutaneous technique , were assessed . Sonoelastographic evaluations were performed at the myotendinous junction , tendon body/lesion site and osteotendinous junction , both for the operated and contralateral side , at 40 days , 6 months and 1 year after surgery . Using st and ard regions of interest , the “ strain index ” ( SI ) was calculated as an indicator of tendon elasticity . Clinical outcomes were assessed by the ATRS question naire at 6 months and 1 year post-operatively and correlated with sonoelastographic findings . Sixty healthy tendons from 30 volunteers were used to provide a healthy control range . Results Twenty-five patients were recruited for this study . The SI in treated tendons showed progressive stiffening over time , especially at myotendinous junction and at the site of the sutured lesion , result ing in significantly higher stiffness than both the contralateral tendon and healthy volunteers . Peak thickness of treated tendons occurred at 6 months , with a tendency to reduce at 1 year , while never achieving a normal physiological state . Greatest remodelling was seen at the lesion site . The contralateral tendon showed significant thickening at the myotendinous and osteotendinous junctions . The SI of the contralateral tendon was found to be stiffer than physiological values found in the control group . ATRS score improved significantly between 6 months and 1 year , being negatively correlated with the SI ( p < 0.001 ) . Conclusion RTSE showed that operatively treated Achilles tendons become progressively stiffer during follow-up , while the ATRS score improved . From a biomechanical point of view , at 1 year after surgery Achilles tendons did not show a “ restitutio ad integrum ” . Real-time sonoelastography provides more qualitative and quantitative details in the diagnostics and follow-up of Achilles tendon conditions as the post-operative evolution of the repairing tissue . Level of evidence Diagnostic and therapeutic study , Level III RATIONALE AND OBJECTIVES Shear wave elastography ( SWE ) has been shown to be a powerful tool to estimate tissue stiffness . The aim of this study was to compare the diagnostic accuracy of SWE to that of st and ard ultrasound ( US ) ( combined use of B-mode US and power Doppler [ PD ] US ) for diagnosing tendinopathies . MATERIAL S AND METHODS This is a prospect i ve institutional review board-approved study on 112 participants ( mean age 42 ± 13.4 years ) with chronic ( > 6 months ) tendon pain in Achilles , patellar , or epicondylar tendons . Participants were systematic ally examined with US , PD , and SWE using a high-resolution linear 15 MHz probe ( SuperSonic Imagine ) . A semiquantitative analysis of SWE color charts and a quantitative region of interest-based analysis of tendon elasticity were performed . SWE values of symptomatic and healthy tendons were compared by using Student t test . Clinical symptom scores served as the st and ard of reference . US findings were compared to clinical symptom scores by using Spearman correlation . RESULTS At semiquantitative analysis of SWE color charts , symptomatic tendons were rated as " soft " in 80/140 ( 57.1 % ) , as " intermediate " in 54/140 ( 38.6 % ) , and as " rigid " in 6/140 ( 4.3 % ) . Healthy tendons were rated as " soft " in 8/84 ( 10 % ) , as " intermediate " in 31/84 ( 37 % ) , and as " rigid " in 45/84 ( 53 % ) . At quantitative analysis , symptomatic tendons exhibited significantly lower mean SWE values ( 60.3 kPa/4.48 m/s ; range 15.3 - 201.4 kPa/2.26 - 14.18 m/s ) than healthy tendons ( 185 kPa/7.85 m/s ; range 56 - 265 kPa/4.32 - 9.23 m/s ) ( P = 0.0004 ) . SWE values correlated closely with patients ' clinical symptoms obtained by clinical scores ( r = 0.81 ) . Overall sensitivity of conventional US and PD in detecting tendinopathies could be enhanced from 67.1 % ( 94/140 ) to 94.3 % ( 132/140 ) when combined with SWE . CONCLUSIONS SWE is a simple way to estimate tissue stiffness and , by reduced tissue rigidity , to identify tendon pathology . SWE significantly increases the diagnostic accuracy of tendon sonography and may prove to be a sensitive tool to early detect or monitor tendinopathy The objective of this study was to investigate the role of real-time sonoelastography ( RTSE ) in patients with lateral epicondylitis ( LE ) and whether it is associated with clinical parameters . Seventeen patients with unilateral LE were enrolled in the study . The healthy elbows of the participants constituted the control group . Using B-mode ultrasound , color Doppler ultrasound , and RTSE ,
Output:
| Conclusion SE appears to be a very useful diagnostic tool , in particular in tendon pathology .
This is a dynamic examination , provides an immediate evaluation of the tissue elasticity , and may be useful in recognizing tendon abnormalities and in implementing the information available with conventional US . |
MS213406 | ***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 : In a previous prospect i ve study , the risk of concussion and all injury was more than threefold higher among Pee Wee ice hockey players ( ages 11–12 years ) in a league that allows bodychecking than among those in a league that does not . We examined whether two years of bodychecking experience in Pee Wee influenced the risk of concussion and other injury among players in a Bantam league ( ages 13–14 ) compared with Bantam players introduced to bodychecking for the first time at age 13 . Methods : We conducted a prospect i ve cohort study involving hockey players aged 13–14 years in the top 30 % of divisions of play in their leagues . Sixty-eight teams from the province of Alberta ( n = 995 ) , whose players had two years of bodychecking experience in Pee Wee , and 62 teams from the province of Quebec ( n = 976 ) , whose players had no bodychecking experience in Pee Wee , participated . We estimated incidence rate ratios ( IRRs ) for injury and for concussion . Results : There were 272 injuries ( 51 concussions ) among the Bantam hockey players who had bodychecking experience in Pee Wee and 244 injuries ( 49 concussions ) among those without such experience . The adjusted IRRs for game-related injuries and concussion overall between players with bodychecking experience in Pee Wee and those without it were as follows : injury overall 0.85 ( 95 % confidence interval [ CI ] 0.63 to 1.16 ) ; concussion overall 0.84 ( 95 % CI 0.48 to 1.48 ) ; and injury result ing in more than seven days of time loss ( i.e. , time between injury and return to play ) 0.67 ( 95 % CI 0.46 to 0.99 ) . The unadjusted IRR for concussion result ing in more than 10 days of time loss was 0.60 ( 95 % CI 0.26 to 1.41 ) . Interpretation : The risk of injury result ing in more than seven days of time loss from play was reduced by 33 % among Bantam hockey players in a league where bodychecking was allowed two years earlier in Pee Wee compared with Bantam players introduced to bodychecking for the first time at age 13 . In light of the increased risk of concussion and other injury among Pee Wee players in a league where bodychecking is permitted , policy regarding the age at which hockey players are introduced to bodychecking requires further consideration Introduction Persistent postconcussive symptoms ( PCSs ) is the persistence of somatic , cognitive , physical , psychological and /or behavioural changes lasting more than 1 month following concussion . Persistent concussion impacts the quality of life through impaired cognition , memory and attention affecting school performance , mood and social engagement . No large epidemiological studies have determined the true prevalence of persistent concussion symptoms . Vali date d , easy-to-use prognosticators do not exist for clinicians to identify children at highest risk . The goal of Predicting and Preventing Postconcussive Problems in Pediatrics study is to derive a clinical prediction rule for the development of persistent postconcussion symptoms in children and adolescents presenting to emergency department following acute head injury . Methods and analysis This study is a prospect i ve , multicentre cohort study across nine academic Canadian paediatric emergency departments . We will recruit the largest prospect i ve epidemiological cohort of children with concussion . Eligible children will be followed using Post-Concussion Symptom Inventory , a vali date d tool in children as young as 5 years . Patients will follow-up at 1 , 2 , 4 , 8 and 12 weeks postinjury . The main outcome will be the presence/absence of PCSs defined as three or more persistent concussion symptoms 1 month following the injury . 1792 patients provide adequate power to derive a clinical decision rule using multivariate analyses to find predictor variables sensitive for detecting cases of persistent postconcussion symptoms . Ethics and dissemination Results of this large prospect i ve study will enable clinicians to identify children at highest risk , optimise treatment and provide families with realistic and appropriate anticipatory guidance . Ethics has been obtained through the Children 's Hospital of Eastern Ontario Research Ethics Board . Results will be disseminated at international conferences and in four manuscripts to peer- review ed journals . Trial registration This study is registered at Clinical trials.gov through the US National Institute of Health/National Library of Medicine ( NCT01873287 ; http:// clinical trials.gov/ct2/show/NCT01873287 ) BACKGROUND The etiology of schizophrenia is believed to include genetic and nongenetic factors , with the pathogenesis involving abnormal neurodevelopment . We investigated whether mild head injury during brain maturation plays a role in the expression of schizophrenia in multiply affected families . METHODS We compared the history and severity of head injuries in childhood ( age , < or = 10 years ) and through adolescence ( age , < or = 17 years ) in 67 subjects with narrowly defined schizophrenia and 102 of their unaffected siblings from 23 multiply affected families . In subjects with schizophrenia , only head injuries preceding the onset of psychosis were considered . RESULTS Subjects in the schizophrenia group ( n = 16 [ 23.9 % ] ) were more likely than the unaffected siblings group ( n = 12 [ 11.8 % ] ) to have a history of childhood head injury ( P = .04 ; odds ratio , 2.35 [ 95 % confidence interval , 1.03 - 5.36 ] ) . Subjects in the schizophrenia group with a history of childhood head injury had a significantly younger median age at onset of psychosis ( 20 years ) compared with those with no such history ( 25 years ; z = -2.98 ; P = .003 ) . The severity of head injury ranged from minimal to mild , including concussions , but within this narrow range , severity was correlated with younger age at onset ( r(s ) = -0.66 ; P = .005 ) . Head injury occurred a median of 12 years before the onset of psychosis . Results were similar if head injuries during adolescence were included , but did not achieve statistical significance . CONCLUSIONS Mild childhood head injury may play a role in the expression of schizophrenia in families with a strong genetic predisposition . Prospect i ve studies of mild head injury should consider genetic predisposition for possible long-term neurobehavioral sequelae Objectives : The question of whether any adverse cognitive or psychosocial outcomes occur after mild head injury in early childhood has evoked considerable controversy . This study examined mild head injury before age 10 and potential differences in late childhood/early adolescence as a function of severity of mild injury and age at injury . Methods : A fully prospect i ve longitudinal design tracked a large birth cohort of children . Confirmed cases of mild head injury before age 10 were divided on the basis of outpatient medical attention ( n=64–84 ) or inpatient observation ( hospital overnight ; n=26–28 ) and compared with the non-injured remainder of the cohort ( reference group ; n=613–807 ) . A range of pre-injury and post-injury child and family characteristics were used to control for any potential confounds . Outcome after injury before and after age 5 was also assessed . Results : After accounting for several demographic , family , and pre-injury characteristics , the inpatient but not the outpatient group displayed increased hyperactivity/inattention and conduct disorder between ages 10 to 13 , as rated by both mothers and teachers . Psychosocial deficits were more prevalent in the inpatient subgroup injured before age 5 . No clear effects were evident for various cognitive/academic measures , irrespective of severity of mild injury or age at injury . Conclusions : Most cases of mild head injury in young children do not produce any adverse effects , but long term problems in psychosocial function are possible in more severe cases , perhaps especially when this event occurs during the preschool years . The view that all mild head injuries in children are benign events requires revision and more objective measures are required to identify cases at risk A 2 1/4-year prospect i ve study of children suffering head injury is described . Three groups of children were studied : ( a ) 31 children with ' severe ' head injuries result ing in a post-traumatic amnesia ( PTA ) of at least 7 days ; ( b ) an individually matched control group of 28 children with hospital-treated orthopaedic injuries ; and ( c ) 29 children with ' mild ' head injuries result ing in a PTA exceeding 1 hour but less than 1 week . A retrospective assessment of the children 's pre-accident behaviour was obtained by parental interview and teacher question naire immediately after the accident and before the behavioural sequelae of the injury could be known . Further psychiatric assessment s were undertaken 4 months , 1 year and 2 1/4 years after the initial injury . The mild head injury group showed a raised level of behavioural disturbance before the accident but no increase thereafter . It was concluded that head injuries result ing in a PTA of less than 1 week did not appreciably increase the psychiatric risk . By contrast , there was a marked increase in psychiatric disorders following severe head injury . The high rate of new disorders in children with severe head injuries who were without disorder before the accident , together with the finding of a dose-response relationship with the severity of brain injury , indicated a causal relationship . However , the development of psychiatric disorders in children with severe head injuries was also influenced by the children 's pre-accident behaviour , their intellectual level , and their psychosocial circumstances . With the exception of social disinhibition and a slight tendency for the disorders to show greater persistence over time , the disorders attributable to head injury showed no specific features OBJECTIVE The impact of mild head injury or mild traumatic brain injury ( TBI ) in children is variable , and determinants of outcome remain poorly understood . There have been no previous attempts to evaluate the impact of interventions to improve outcome . Results of previous intervention studies in adults have been mixed . This study aim ed to evaluate the impact of providing information on outcome measured in terms of reported symptoms , cognitive performance , and psychological adjustment in children 3 months after injury . METHODS A total of 61 children with mild TBI were assessed 1 week and 3 months after injury , and 58 children with mild TBI were assessed 3 months after injury only . They were compared with 2 control groups ( N = 45 and 47 ) of children with minor injuries not involving the head . Participants completed measures of preinjury behavior and psychological adjustment , postconcussion symptoms , and tests of attention , speed of information processing , and memory . Children with mild TBI seen at 1 week were also given an information booklet outlining symptoms associated with mild TBI and suggested coping strategies . Those seen 3 months after injury only did not receive this booklet . RESULTS Children with mild TBI reported more symptoms than controls at 1 week but demonstrated no impairment on neuropsychological measures . Initial symptoms had resolved for most children by 3 months after injury , but a small group of children who had previous head injury or a history of learning or behavioral difficulties reported ongoing problems . The group not seen at 1 week and not given the information booklet reported more symptoms overall and was more stressed 3 months after injury . CONCLUSIONS Providing an information booklet reduces anxiety and thereby lowers the incidence of ongoing problems The degree to which postinjury posttraumatic stress disorder ( PTSD ) and /or depressive symptoms in adolescents are associated with cognitive and functional impairments at 12 and 24 months after traumatic brain injury ( TBI ) is not yet known . The current study used a prospect i ve cohort design , with baseline assessment and 3- , 12- , and 24-month followup , and recruited a cohort of 228 adolescents ages 14 - 17 years who sustained either a TBI ( n = 189 ) or an isolated arm injury ( n = 39 ) . Linear mixed-effects regression was used to assess differences in depressive and PTSD symptoms between TBI and arm-injured patients and to assess the association between 3-month PTSD and depressive symptoms and cognitive and functional outcomes . Results indicated that patients who sustained a mild TBI without intracranial hemorrhage reported significantly worse PTSD ( Hedges g = 0.49 , p = .01 ; Model R(2 ) = .38 ) symptoms across time as compared to the arm injured control group . Greater levels of PTSD symptoms were associated with poorer school ( η(2 ) = .07 , p = .03 ; Model R(2 ) = .36 ) and physical ( η(2 ) = .11 , p = .01 ; Model R(2 ) = .23 ) functioning , whereas greater depressive symptoms were associated with poorer school ( η(2 ) = .06 , p = .05 ; Model R(2 ) = .39 ) functioning Background Concussion is one of the most commonly occurring injuries in sport today . The Sport Concussion Assessment Tool ( SCAT ) is a commonly used paper neurocognitive tool . To date , little is known about SCAT baseline normative values in youth athletes . Objective The purpose of this study was to determine normative values on the SCAT for male and female youth hockey players . Methods This is a secondary data analysis of pooled data from three prospect i ve cohort studies examining the risk of injury in paediatric ice hockey players aged 9–17 years . A preseason baseline demographic and injury history question naire was completed by each player . Results A total of 4193 players completed SCATs at baseline and were included in the analysis . 781 players ( 18.6 % ) reported a previous history of concussion . Fatigue and low energy followed by headache were the most commonly reported symptoms in all players . The majority of youth players could recite all five words
Output:
| Based on the literature included in this systematic review , psychological and psychiatric problems in children with a history of mTBI were found to be more prevalent when mTBI is associated with hospitalization , when assessment occurs earlier in the recovery period ( that is , resolves over time ) , when there are multiple previous mTBIs , in individuals with preexisting psychiatric illness , when outcomes are based on retrospective recall , and when the comparison group is noninjured healthy children ( as opposed to children with injuries not involving the head ) .
In the absence of true reports of preinjury problems and when ideally comparing mild TBI to non-TBI injured controls , there is little evidence to suggest that psychological , behavioural , and /or psychiatric problems persist beyond the acute and subacute period following an mTBI in children and adolescents |
MS213407 | ***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 Childhood risk factors for the development of adult schizophrenia have proved to have only modest and nonspecific effects , and most seem unrelated to the adult phenotype . We report the first direct examination of the longitudinal relationship between psychotic symptoms in childhood and adulthood . METHODS We analyzed prospect i ve data from a birth cohort ( N = 761 ) , in which children were asked about delusional beliefs and hallucinatory experiences at age 11 years , and then followed up to age 26 years . Structured diagnostic interviews were employed at both ages and self-report of schizophreniform symptoms was augmented by other data sources at age 26 years . RESULTS Self-reported psychotic symptoms at age 11 years predicted a very high risk of a schizophreniform diagnosis at age 26 years ( odds ratio , 16.4 ; 95 % confidence interval , 3.9 - 67.8 ) . In terms of attributable risk , 42 % of the age-26 schizophreniform cases in the cohort had reported 1 or more psychotic symptoms at age 11 years . Age-11 psychotic symptoms did not predict mania or depression at age 26 years , suggesting specificity of prediction to schizophreniform disorder . The link between child and adult psychotic symptoms was not simply the result of general childhood psychopathology . CONCLUSION These findings provide the first evidence for continuity of psychotic symptoms from childhood to adulthood BACKGROUND In the UK and The Netherl and s , people with high rates of psychosis are chronically exposed to discrimination . AIMS To test whether perceived discrimination is associated longitudinally with onset of psychosis . METHOD A 3-year prospect i ve study of cohorts with no history of psychosis and differential rates of reported discrimination on the basis of age , gender , disability , appearance , skin colour or ethnicity and sexual orientation was conducted in the Dutch general population ( n=4076 ) . The main outcome was onset of psychotic symptoms ( delusions and hallucinations ) . RESULTS The rate of delusional ideation was 0.5 % ( n=19 ) in those who did not report discrimination , 0.9 % ( n=4 ) in those who reported discrimination in one domain , and 2.7 % ( n=3 ) in those who reported discrimination in more than one domain ( exact P=0.027 ) . This association remained after adjustment for possible confounders . No association was found between baseline discrimination and onset of hallucinatory experiences . CONCLUSIONS Perceived discrimination may induce delusional ideation and thus contribute to the high observed rates of psychotic disorder in exposed minority population OBJECTIVES Previous research into schizotypy has shown that certain groups of people have similar experiences to the positive symptoms of schizophrenia but remain functioning members of society , such as those with profound religious experiences ( Jackson & Fulford , 1997 ) . METHOD The focus of the present study was to explore the incidence of delusional ideation in New Religious Movements ( NRMs ) . Hare Krishnas and Druids were compared to two control groups ( non-religious and Christian ) , and to deluded , psychotic in- patients on two delusions measures . RESULTS As predicted , individuals from the NRMs scored significantly higher than the control groups on all the delusional measures apart from levels of distress . They did not show as much florid symptomatology as the psychotic patients , but could not be differentiated from the deluded group on the number of delusional items endorsed on the Peters et al. Delusions Inventory ( PDI ; Peters , Day & Garety , 1996 ) , or on levels of conviction . However , they were significantly less distressed and preoccupied by their experiences . No differences were found between the two control groups on any of the delusional measures , suggesting that religious beliefs per se do not account for the NRMs members ' scores . DISCUSSION These findings provide further support for , first , the notion of a continuum between normality and psychosis and , second , for the necessity to consider the multidimensionality of delusional beliefs In traditional Western psychiatric theory , seeing or hearing things that other people do not think are there could be termed a hallucination which is often considered indicative of underlying psychopathology . The psychiatric interpretation of pathological meanings of these experiences for an individual can be contrasted with an anthropologic approach which considers whether there are underlying cultural influences to account for certain distributions of reported hallucinations and their content and to ask about the social and spiritual , as well as psychologic , meanings of such experiences . This paper presents data on reported hallucinations in a r and om sample of the general population of a county in north central Florida . When the results of the questions on hallucinations were compared in relation to sociodemographic variables , it was found that hallucinations were more commonly reported by the young , by blacks , by members of the lower socioeconomic quintiles and by those belonging to certain church types . These data will be discussed from the complementing and contrasting psychiatric and anthropologic viewpoints College undergraduates ( n = 34 ) identified by deviant scores ( at least 1.96 SD above the mean ) on the Revised Social Anhedonia ( SocAnh ) Scale ( M. Eckblad , L. J. Chapman , J. P. Chapman , & M. Mishlove , 1982 ) were compared with control participants ( n = 139 ) at an initial assessment and at a 10-year follow-up evaluation . Twenty-four percent of the SocAnh group were diagnosed with schizophrenia-spectrum disorders at the follow-up compared with only 1 % of the control group , despite the fact that there had been no such difference between the groups at the initial assessment 10 years earlier . The SocAnh group exceeded the control group on severity of psychotic-like experiences and had poorer overall adjustment at the follow-up but not at the initial assessment . The groups did not differ on mood symptoms or substance-use disorders . Thus , the SocAnh Scale , unlike the Perceptual Aberration and Magical Ideation Scales , appears to identify individuals at specific risk for future development of schizophrenia-spectrum disorders OBJECTIVE Reports of increased rates of psychosis in prisons could be due to sampling and ascertainment differences . The authors compared two sample s of subjects 16 - 64 years of age : those from the general population of residents in Great Britain and prisoners in Engl and and Wales . METHOD A r and om sample of rem and ed and sentenced male and female prisoners ( N=3,142 ) and a two-phase , cross-sectional r and om sample of household residents ( N=10,108 ) were assessed with structured question naires and the semistructured Schedules for Clinical Assessment in Neuropsychiatry . RESULTS The weighted prevalence of probable functional psychosis in the past year was 4.5 per thous and ( 95 % CI=3.1 to 5.8 ) in the household survey . In the prison survey , the weighted prevalence was over 10 times greater : 52 per thous and ( 95 % CI=45 to 60 ) . One in four prisoners with a psychotic disorder had psychotic symptoms attributed to toxic or withdrawal effects of psychoactive substances . The proportion of subjects with specific types of hallucinations or delusions did not differ between prison and household psychosis cases . CONCLUSIONS This large study using st and ardized comparisons showed that the prevalence of psychosis in prisons is substantially higher than in the community and is deserving of greater attention to treatment and prevention . Apart from a minority of prisoners with symptoms attributable to psychoactive substances , the clinical symptom profile of psychosis is the same in both setting s. Longitudinal research is needed to better underst and these prevalence differences The Dissociative Experiences Scale was administered to a r and om sample of 1,055 adults in the city of Winnipeg . Results showed that scale scores did not differ between men and women and were not influenced by income , employment status , education , place of birth , religious affiliation , or number of persons in the respondent 's household . Dissociative experiences are common in the general population and decline with age . The findings suggest that dissociative disorders may also be common in the general population Prospect i ve longitudinal investigations are needed to identify causal processes leading to schizophrenia . However , there is presently no cost-effective way to identify children who are at risk of developing schizophrenia spectrum disorders : Although having a family history of schizophrenia is associated with elevated risk for developing spectrum disorders , the majority of individuals with schizophrenia do not have an afflicted relative . The present study aim ed to test the feasibility of screening a community sample of children , aged 9 to 12 years , to identify children who experienced a triad of putative antecedents of schizophrenia that had been identified from previous research , including : ( 1 ) speech and /or motor development lags or problems ; ( 2 ) social , emotional , or behavioural problems ; and ( 3 ) psychotic-like-experiences ( PLEs ) . 548 children and 264 caregivers completed question naires . 9.2 % of boys and 4.1 % of girls displayed the triad of antecedents . 58.9 % of the children reported " certain experience " of one or more PLEs . The results suggest that question naire screening of community sample s of children for the putative antecedents of schizophrenia spectrum disorders is feasible . Accuracy of identification will only be established by follow-up studies This article presents a prospect i ve analysis of an antecedent psychopathologic features and sociodemographic risk factors in schizophrenia with data from five community sites in the National Institute of Mental Health Epidemiologic Catchment Area Program . Three nonoverlapping psychotic cases were defined using DSM-III definitions as implemented by the Diagnostic Interview Schedule ( DIS ) : ( 1 ) DSM-III Schizophrenia Criterion A ; ( 2 ) Criterion A and Affective Episode ; and ( 3 ) full Schizophrenia . In a 1-year follow-up period , the cumulative incidence rate of Criterion A was 0.79 per 100 , for Criterion A with Affective Episode it was 0.17 per 100 , and for Schizophrenia the rate was 0.20 per 100 . In multivariable logistic regression modeling , the patterns of associations between sociodemographic factors and DIS/DSM-III Schizophrenia resembled patterns in clinical ly based registry data . Male subjects had an earlier peak onset than female subjects , and marital status and employment were strongly related to odds of developing DIS/DSM-III Schizophrenia . An interaction between gender and never marrying showed never-married men at 50 times higher odds of developing DIS/DSM-III Schizophrenia , never-married women at 14 times higher odds , and married women at 2.5 times higher odds , relative to married men . Adjusting for sociodemographic factors , DIS/DSM-III Obsessive Compulsive Disorder and Social Phobia were both associated with more than 3.5 times increased odds of developing DIS/DSM-III Schizophrenia . Several other psychopathology items , including panic attacks , were associated with increased odds of developing DIS/DSM-III Schizophrenia . There were both similarities and differences in risk factor structure between DIS/DSM-III Schizophrenia and the other two defined categories of case BACKGROUND Urban and rural population s have different rates of psychotic illness . If psychosis exists as a continuous phenotype in nature , urban-rural population differences in the rate of psychotic disorder should be accompanied by similar differences in the rate of abnormal mental states characterized by psychotic or psychosislike symptoms . METHODS A r and om sample of 7076 individuals aged 18 to 64 years were interviewed by trained lay interviewers with the Composite International Diagnostic Interview . Approximately half of those with evidence of psychosis according to the Composite International Diagnostic Interview were additionally interviewed by clinicians . We investigated associations between a 5-level urbanicity rating and ( 1 ) any DSM-III-R diagnosis of psychotic disorder ( sample prevalence , 1.5 % ) , ( 2 ) any rating of hallucinations and /or delusions ( sample prevalence , 4.2 % ) , and ( 3 ) any rating of psychotic or psychosislike symptoms ( sample prevalence , 17.5 % ) . RESULTS Level of urbanicity was associated not only with DSM-III-R psychotic disorder ( adjusted odds ratio [ OR ] over 5 levels , 1.47 ; 95 % confidence interval [ CI ] , 1.25 - 1.72 ) , but also , independently , with any rating of delusion and /or hallucination ( adjusted OR , 1.28 ; 95 % CI , 1.17 - 1.40 ; clinician-assessed psychotic symptoms only : OR , 1.30 ; 95 % CI , 1.03 - 1.64 ) and any rating of psychosislike symptom ( adjusted OR , 1.18 ; 95 % CI , 1.13 - 1.24 ) . Psychotic symptoms were strongly and independently associated with psychotic disorder , regardless of the level of urbanization . CONCLUSIONS Community level of psychotic and psychosislike symptoms may be inextricably linked to the prevalence of psychotic disorder . The prevalence of abnormal mental states that facilitate development to overt psychotic illness increases progressively with level of urbanization Abstract . Aims : The cross-sectional association between tobacco use and psychotic features has been well established . If psychotic features precede tobacco use , then tobacco may be used to self-medicate psychotic symptoms . The aim was to assess if psychotic features in adolescents constitute a risk factor for later tobacco use . Design : A r and om target sample of 2,600 children aged 4–16 years from the Dutch general population was followed up across a 14-year interval
Output:
| There is evidence , however , that transitory developmental expression of psychosis ( psychosis proneness ) may become abnormally persistent ( persistence ) and subsequently clinical ly relevant ( impairment ) , depending on the degree of environmental risk the person is additionally exposed to .
The psychosis proneness-persistence-impairment model considers genetic background factors impacting on a broadly distributed and transitory population expression of psychosis during development , poor prognosis of which , in terms of persistence and clinical need , is predicted by environmental exposure interacting with genetic risk |
MS213408 | ***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 Substance abuse frequently complicates the course of bipolar illness , promotes mixed states , and contributes to poor outcome in mania . Preliminary open trials suggest that anticonvulsant mood stabilizers may enhance remission rates and outcome for bipolar patients with substance abuse . This study compared remission patterns for mixed or pure manic episodes among bipolar in patients with or without substance abuse histories . METHOD Hospital records were retrospectively review ed for 204 DSM-III-R bipolar I in patients . Clinical features were compared for those with or without substance abuse/dependence histories predating the index manic episode . Time until remission was analyzed by Kaplan-Meier survival analysis . Naturalistic treatment outcome with lithium or anticonvulsant mood stabilizers was compared for those with or without past substance abuse . RESULTS Past substance abuse was evident in 34 % of the bipolar sample and comprised most often alcoholism ( 82 % ) , followed by cocaine ( 30 % ) , marijuana ( 29 % ) , sedative-hypnotic or amphetamine ( 21 % ) , and opiate ( 13 % ) abuse . Substance abuse was more common among men ( p < .05 ) and those with mixed rather than pure mania ( p < .05 ) . Remission during hospitalization was less likely among patients with prior substance abuse ( p < .05 ) , especially alcohol or marijuana abuse , and among mixed manic patients with past substance abuse ( p < .05 ) . Bipolar patients with substance abuse histories who received divalproex or carbamazepine remitted during hospitalization more often than did those who received lithium as the sole mood stabilizer ( p < .05 ) . CONCLUSION These findings support previous reports suggesting that bipolar patients with past substance abuse have poorer naturalistic treatment outcomes , but may show a better response to anticonvulsant mood stabilizers than lithium CONTEXT Although an association between mood disorders and substance use disorders has been well established , there is a lack of long-term prospect i ve data on the order of onset and subtypes of mood disorders associated with specific substances and their progression . OBJECTIVE To estimate the respective risks posed by subtypes of mood disorders or bipolar spectrum conditions for the subsequent development of substance use disorders . DESIGN Six waves of direct diagnostic interviews were administered to a sample of young adults during a 20-year period . Mood disorders and syndromes assessed at each interview were used to predict the cumulative incidences of substance use disorders at subsequent interview waves . PARTICIPANTS We followed up 591 individuals ( 292 men and 299 women ) who were selected at study enrollment from a representative sample of young adults in Zurich , Switzerl and . MAIN OUTCOME MEASURES Structured Diagnostic Interview for Psychopathologic and Somatic Syndromes , a semistructured clinical interview that collected data on the spectrum of expression of mood disorders and substance use and disorders for DSM-III-R and DSM-IV criteria . RESULTS Individuals having manic symptoms were at significantly greater risk for the later onset of alcohol abuse/dependence , cannabis use and abuse/dependence , and benzodiazepine use and abuse/dependence . Bipolar II disorder predicted both alcohol abuse/dependence and benzodiazepine use and abuse/dependence . In contrast , major depression was predictive only of later benzodiazepine abuse/dependence . CONCLUSIONS In comparison with major depression , bipolar II disorder was associated with the development of alcohol and benzodiazepine use and disorders . There was less specificity of manic symptoms that tended to predict all levels of the substances investigated herein . The different patterns of association between mood disorders and substance use trajectories have important implication s for prevention and provide lacking information about underlying mechanisms BACKGROUND The association between early childhood abuse and the course of illness , including psychiatric comorbidities , in adults with bipolar disorder has not been examined in a predominantly male or veteran population . METHODS As part of the VA Cooperative Study 430 , " Reducing the Efficacy-Effectiveness Gap in Bipolar Disorder , " 330 veterans ( 91 % male ) with bipolar I or II disorder who were enrolled in a 3-year prospect i ve study were examined for baseline data obtained at study entry . Diagnoses were determined by the use of the SCID . A semistructured interview design ed to elicit data about exposure to childhood physical , sexual , or combined abuse was conducted as part of baseline demographic and clinical information . Other reports from this data set have not addressed the issues of childhood adversity . RESULTS Childhood abuse was reported by 48.3 % of the subjects ( 47.3 % of men ) . Any abuse ( AA ) was reported by 48.3 % ; sexual abuse without physical abuse ( SA ) was reported by 8 % , physical abuse without sexual abuse ( PA ) by 20.7 % , and both types of abuse ( combined abuse , CA ) by 18.7 % of the male subjects . Female veterans reported more SA ( 27 % ) and less PA ( 6.7 % ) . AA subjects were more likely to have current PTSD and lifetime diagnoses of panic disorder and alcohol use disorders . CA was associated with lower SF-36 Mental scores , higher likelihood of current PTSD and lifetime diagnoses of alcohol use disorders , as well as more lifetime episodes of major depression and higher likelihood of at least one suicide attempt . Younger age at study entry was associated with AA and PA . LIMITATIONS Potential limitations include generalizability beyond the male , veteran population of patients with bipolar disorder and the methodology used to elicit abuse histories . CONCLUSIONS Similar to studies of predominantly female nonveteran sample s , this study extends the finding that a history of childhood abuse acts as a disease course modifier in male veterans with bipolar disorder . Clinicians should routinely seek information regarding abuse and be aware that these patients may be more difficult to treat than bipolar patients who have no abuse histories OBJECTIVE To evaluate the prevalence of substance abuse dependence and /or alcohol abuse dependence among subjects with bipolar I versus bipolar II disorder in a voluntary registry . METHOD One hundred r and omly selected registrants in a voluntary case registry for bipolar disorder were interviewed , using the Structured Clinical Interview for DSM-IV Axis I Disorders , to vali date the diagnosis of this registry . Corroborative information was obtained from medical records , family members and the treating psychiatrist . Eighty-nine adults ( 18 - 65 years ) met criteria for bipolar disorder ( bipolar I = 71 , bipolar II = 18 ) and were included in this analysis . RESULTS Forty-one ( 57.8 % ) subjects with bipolar I disorder abused , or were dependent on one or more substances or alcohol , 28.2 % abused , or were dependent on , two substances or alcohol , and 11.3 % abused or were dependent on three or more substances or alcohol . Nearly 39 % of bipolar II subjects abused or were dependent on one or more substances , nearly 17 % were dependent on two or more substances or alcohol , and 11 % were dependent on three or more substances or alcohol . Alcohol was the most commonly abused drug among either bipolar I or II subjects . CONCLUSIONS Consistent with other epidemiologic and hospital population studies , this voluntary bipolar disorder registry suggests a high prevalence of comorbidity with alcohol and /or substance abuse dependence . Bipolar I subjects appear to have higher rates of these comorbid conditions than bipolar II subjects ; however , as the number of bipolar II subjects was rather small , this suggestion needs confirmation OBJECTIVE The prevalence of lifetime alcohol abuse and /or dependence ( alcoholism ) in patients with bipolar disorder has been reported to be higher than in all other axis I psychiatric diagnoses . This study examined gender-specific relationships between alcoholism and bipolar illness , which have previously received little systematic study . METHOD The prevalence of lifetime alcoholism in 267 out patients enrolled in the Stanley Foundation Bipolar Network was evaluated by using the Structured Clinical Interview for DSM-IV . Alcoholism and its relationship to retrospectively assessed measures of the course of bipolar illness were evaluated by patient-rated and clinician-administered question naires . RESULTS As in the general population , more men ( 49 % , 57 of 116 ) than women with bipolar disorder ( 29 % , 44 of 151 ) met the criteria for lifetime alcoholism . However , the risk of having alcoholism was greater for women with bipolar disorder ( odds ratio=7.35 ) than for men with bipolar disorder ( odds ratio=2.77 ) , compared with the general population . Alcoholism was associated with a history of polysubstance use in women with bipolar disorder and with a family history of alcoholism in men with bipolar disorder . CONCLUSIONS This study suggests that there are gender differences in the prevalence , risk , and clinical correlates of alcoholism in bipolar illness . Although this study is limited by the retrospective assessment of illness variables , the magnitude of these gender-specific differences is substantial and warrants further prospect i ve study OBJECTIVE Previous work has shown that manic-depressive illness and alcohol abuse are linked . This study further explores the relationship of alcohol and drug abuse in bipolar I patients and unipolar depressives and a comparison group obtained through the acquaintance method . METHOD Diagnosis was accomplished according to Research Diagnostic Criteria ( RDC ) : controls = 469 ; bipolars = 277 ; unipolar depressives = 678 . Systematic data were gathered using the SADS on lifetime and current drug abuse and alcoholism . Both patients and comparison subjects were then followed prospect ively for 10 years . First degree family members were interviewed using the RDC family history method . RESULTS The group of bipolar patients and the group of unipolar patients had higher rates of drug and alcohol abuse than the comparison group when primary and secondary affective disorder patients were combined . However , primary unipolar patients did not have higher rates of alcohol or drug abuse than the comparison group . In contrast , primary bipolar patients had higher rates of alcoholism , stimulant abuse , and ever having abused a drug than the primary unipolar group and the control group . In an evaluation of the bipolar patients , drug abusers were significantly younger at intake and had a significantly younger age of onset of bipolar disorder . There was a significant increase in family history of mania or schizoaffective mania in the drug-abusing bipolar patients as compared to the non-abusing bipolar patients . LIMITATION As in all adult sample s of patients with affective illness , the chronology of alcohol and substance problems vis-à-vis the onset of illness was determined retrospectively . CONCLUSIONS ( 1 ) Alcoholism and drug abuse are more frequent in bipolar than unipolar patients . ( 2 ) The drug abuse of bipolar patients tends toward the abuse of stimulant drugs . ( 3 ) In a bipolar patient , familial diathesis for mania is significantly associated with the abuse of alcohol and drugs . ( 4 ) More provocatively , these findings suggest the hypothesis of a common familial-genetic diathesis for a subtype of bipolar I , alcohol and stimulant abuse . CLINICAL IMPLICATION S The present analyses , coupled with two previous ones from the CDS , suggest that drug abuse may precipitate an earlier onset of bipolar I disorder in those who already have a familial predisposition for mania . Furthermore , in dually diagnosed patients with manic-depressive and alcohol/stimulant abuse history , mood stabilization of the bipolar disorder represents a rational approach to control concurrent alcohol and drug problems , and should be studied in systematic controlled trials In light of the established influence of substance use on the onset , course , and outcome of bipolar disorder , we performed a retrospective chart review of patients with bipolar I disorder participating in a r and omized controlled trial to further investigate the relationship between alcohol and substance use and first onset of mania . A total of 59.4 % ( N=101 ) of the 170 participants were determined to have a history of substance and /or alcohol use . Among the 101 participants with SU , use was coded in 10 ( 9.9 % ) as immediately preceding , in 50 ( 49.5 % ) as preceding mania , in 7 ( 6.9 % ) as following mania , and in 34 ( 33.7 % ) as indeterminable . Of the 10 participants with immediately preceding use , 5 experienced their first manic episode immediately after discontinuing a substance . Our findings support earlier reports detailing the high prevalence of substance use among patients with bipolar disorder . Treatments targeting alcohol and substance use among individuals with bipolar disorder are clearly needed , as are prophylactic treatments targeting adolescents and young adults who are at risk for either bipolar disorder or alcohol and substance related disorders BACKGROUND There is a need for comparisons of long-term outcomes in bipolar disorder patients with predominantly manic symptoms vs. predominantly depressive symptoms , especially the course of comorbid alcohol/substance abuse . METHOD A naturalistic sample of bipolar I patients ( n=120 ) was followed prospect ively for up to 10years . At baseline , number and polarity of past episodes were used to classify patients as predominantly manic or predominantly depressive if there were more manic or more depressive episodes , respectively . 25 patients were excluded from the analyses . Outcomes including episodes , hospitalisations and suic
Output:
| AUDs are highly prevalent in BD .
Our study revealed a substantial heterogeneity across studies . |
MS213409 | ***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: MET amplification activates ERBB3/PI3K/AKT signaling in EGFR mutant lung cancers and causes resistance to EGFR kinase inhibitors . We demonstrate that MET activation by its lig and , HGF , also induces drug resistance , but through GAB1 signaling . Using high-throughput FISH analyses in both cell lines and in patients with lung cancer , we identify sub population s of cells with MET amplification prior to drug exposure . Surprisingly , HGF accelerates the development of MET amplification both in vitro and in vivo . EGFR kinase inhibitor resistance , due to either MET amplification or autocrine HGF production , was cured in vivo by combined EGFR and MET inhibition . These findings highlight the potential to prospect ively identify treatment naive , patients with EGFR-mutant lung cancer who will benefit from initial combination therapy PURPOSE V and etanib is a once-daily oral inhibitor of vascular endothelial growth factor receptor ( VEGFR ) and epidermal growth factor receptor ( EGFR ) signaling . In this two-part phase II study , the efficacy and safety of v and etanib was compared with that of gefitinib , an inhibitor of EGFR signaling . PATIENTS AND METHODS Patients ( N = 168 ) with locally advanced or metastatic ( stage IIIB/IV ) non-small-cell lung cancer ( NSCLC ) , after failure of first-line with or without second-line platinum-based chemotherapy , received once-daily v and etanib 300 mg ( n = 83 ) or gefitinib 250 mg ( n = 85 ) until disease progression or evidence of toxicity ( part A ) . After a 4-week washout period , eligible patients had the option to switch to the alternative treatment ( part B ) . Progression-free survival ( PFS ) was the primary efficacy assessment in part A , which was design ed to have a higher than 75 % power to detect a 33 % prolongation of PFS at a one-sided significance level of .2 . RESULTS In part A , v and etanib prolonged PFS compared with gefitinib ( hazard ratio = 0.69 ; 95 % CI , 0.50 to 0.96 ; one-sided P = .013 ) . Patients receiving v and etanib experienced adverse events that were manageable and generally consistent with inhibition of EGFR and VEGFR signaling , including diarrhea , rash , and hypertension . There were no unexpected safety findings with gefitinib . Overall survival , a secondary assessment , was not significantly different between patients initially r and omly assigned to either v and etanib or gefitinib . CONCLUSION The primary efficacy objective was achieved , with v and etanib demonstrating a significant prolongation of PFS versus gefitinib . V and etanib 300 mg/d is currently being evaluated as a monotherapy in two r and omized phase III studies in advanced NSCLC BACKGROUND Bevacizumab and erlotinib target different tumour growth pathways with little overlap in their toxic-effect profiles . On the basis of promising results from a phase 1/2 trial assessing safety and activity of erlotinib plus bevacizumab for recurrent or refractory non-small-cell lung cancer ( NSCLC ) , we aim ed to assess efficacy and safety of this combination in a phase 3 trial . METHODS In our double-blind , placebo-controlled , r and omised phase 3 trial ( BeTa ) , we enrolled patients with recurrent or refractory NSCLC who presented to 177 study sites in 12 countries after failure of first-line treatment . Patients were r and omly allocated in a one-to-one ratio to receive erlotinib plus bevacizumab ( bevacizumab group ) or erlotinib plus placebo ( control group ) according to a computer-generated r and omisation sequence by use of an interactive voice response system . The primary endpoint was overall survival in all enrolled patients . Patients , study staff , and investigators were masked to treatment assignment . We assessed safety by calculation of incidence of adverse events and tissue was collected for biomarker analyses . This trial is registered with Clinical Trials.gov , number NCT00130728 . FINDINGS Overall survival did not differ between 317 controls and 319 patients in the bevacizumab group ( hazard ratio [ HR ] 0·97 , 95 % CI 0·80 - 1·18 , p=0·7583 ) . Median overall survival was 9·3 months ( IQR 4·1 - 21·6 ) for patients in the bevacizumab group compared with 9·2 months ( 3·8 - 20·2 ) for controls . Progression-free survival seemed to be longer in the bevacizumab group ( 3·4 months [ 1·4 - 8·4 ] ) than in the control group ( 1·7 months [ 1·3 - 4·1 ] ; HR 0·62 , 95 % CI 0·52 - 0·75 ) and objective response rate suggested some clinical activity of bevacizumab and erlotinib . However , these secondary endpoint differences could not be defined as significant because the study prespecified that the primary endpoint had to be significant before testing of secondary endpoints could be done , to control type I error rate . In the bevacizumab group , 130 ( 42 % ) of 313 patients with safety data had a serious adverse event , compared with 114 ( 36 % ) controls . There were 20 ( 6 % ) grade 5 adverse events , including two arterial thromboembolic events , in the bevacizumab group , and 14 ( 4 % ) in the control group . INTERPRETATION Addition of bevacizumab to erlotinib does not improve survival in patients with recurrent or refractory NSCLC . FUNDING Genentech PURPOSE Bevacizumab , a humanized anti-vascular endothelial growth factor monoclonal antibody , and erlotinib , a reversible , orally available epidermal growth factor receptor tyrosine kinase inhibitor , have demonstrated evidence of a survival benefit in the treatment of non-small-cell lung cancer ( NSCLC ) . A single-arm phase I and II study of bevacizumab plus erlotinib demonstrated encouraging efficacy , with a favorable safety profile . PATIENTS AND METHODS A multicenter , r and omized phase II trial evaluated the safety of combining bevacizumab with either chemotherapy ( docetaxel or pemetrexed ) or erlotinib and preliminarily assessed these combinations versus chemotherapy alone , as measured by progression-free survival ( PFS ) . All patients had histologically confirmed nonsquamous NSCLC that had progressed during or after one platinum-based regimen . RESULTS One hundred twenty patients were r and omly assigned and treated . No unexpected adverse events were noted . Fewer patients ( 13 % ) in the bevacizumab-erlotinib arm discontinued treatment as a result of adverse events than in the chemotherapy alone ( 24 % ) or bevacizumab-chemotherapy ( 28 % ) arms . The incidence of grade 5 hemorrhage in patients receiving bevacizumab was 5.1 % . Although not statistically significant , relative to chemotherapy alone , the risk of disease progression or death was 0.66 ( 95 % CI , 0.38 to 1.16 ) among patients treated with bevacizumab-chemotherapy and 0.72 ( 95 % CI , 0.42 to 1.23 ) among patients treated with bevacizumab-erlotinib . One-year survival rate was 57.4 % for bevacizumab-erlotinib and 53.8 % for bevacizumab-chemotherapy compared with 33.1 % for chemotherapy alone . CONCLUSION Results for PFS and overall survival favor combination of bevacizumab with either chemotherapy or erlotinib over chemotherapy alone in the second-line setting . No unexpected safety signals were noted . The rate of fatal pulmonary hemorrhage was consistent with previous bevacizumab trials . The toxicity profile of the bevacizumab-erlotinib combination is favorable compared with either chemotherapy-containing group BACKGROUND Bevacizumab , a monoclonal antibody against vascular endothelial growth factor , has been shown to benefit patients with a variety of cancers . METHODS Between July 2001 and April 2004 , the Eastern Cooperative Oncology Group ( ECOG ) conducted a r and omized study in which 878 patients with recurrent or advanced non-small-cell lung cancer ( stage IIIB or IV ) were assigned to chemotherapy with paclitaxel and carboplatin alone ( 444 ) or paclitaxel and carboplatin plus bevacizumab ( 434 ) . Chemotherapy was administered every 3 weeks for six cycles , and bevacizumab was administered every 3 weeks until disease progression was evident or toxic effects were intolerable . Patients with squamous-cell tumors , brain metastases , clinical ly significant hemoptysis , or inadequate organ function or performance status ( ECOG performance status , > 1 ) were excluded . The primary end point was overall survival . RESULTS The median survival was 12.3 months in the group assigned to chemotherapy plus bevacizumab , as compared with 10.3 months in the chemotherapy-alone group ( hazard ratio for death , 0.79 ; P=0.003 ) . The median progression-free survival in the two groups was 6.2 and 4.5 months , respectively ( hazard ratio for disease progression , 0.66 ; P<0.001 ) , with corresponding response rates of 35 % and 15 % ( P<0.001 ) . Rates of clinical ly significant bleeding were 4.4 % and 0.7 % , respectively ( P<0.001 ) . There were 15 treatment-related deaths in the chemotherapy-plus-bevacizumab group , including 5 from pulmonary hemorrhage . CONCLUSIONS The addition of bevacizumab to paclitaxel plus carboplatin in the treatment of selected patients with non-small-cell lung cancer has a significant survival benefit with the risk of increased treatment-related deaths . ( Clinical Trials.gov number , NCT00021060 . Background : Sunitinib malate ( SUTENT ) has promising single-agent activity given on Schedule 4/2 ( 4 weeks on treatment followed by 2 weeks off treatment ) in advanced non-small cell lung cancer ( NSCLC ) . Methods : We examined the activity of sunitinib on a continuous daily dosing ( CDD ) schedule in an open-label , multicentre phase II study in patients with previously treated , advanced NSCLC . Patients ⩾18 years with stage IIIB/IV NSCLC after failure with platinum-based chemotherapy , received sunitinib 37.5 mg per day . The primary end point was objective response rate ( ORR ) . Secondary end points included progression-free survival ( PFS ) , overall survival ( OS ) , 1-year survival rate , and safety . Results : Of 47 patients receiving sunitinib , one patient achieved a confirmed partial response ( ORR 2.1 % ( 95 % confidence interval ( CI ) 0.1 , 11.3 ) ) and 11 ( 23.4 % ) had stable disease ( SD ) ⩾8 weeks . Five patients had SD>6 months . Median PFS was 11.9 weeks ( 95 % CI 8.6 , 14.1 ) and median OS was 37.1 weeks ( 95 % CI 31.1 , 69.7 ) . The 1-year survival probability was 38.4 % ( 95 % CI 24.2 , 52.5 ) . Treatment was generally well tolerated . Conclusions : The safety profile and time-to-event analyses , albeit relatively low response rate of 2 % , suggest single-agent sunitinib on a CDD schedule may be a potential therapeutic agent for patients with advanced , refractory NSCLC 3549 Background : ARQ197 ( A ) is a selective , non-ATP competitive inhibitor of c-Met , a receptor tyrosine kinase implicated in tumor cell migration , invasion , and proliferation . Phase I data for ARQ 197 monotherapy is previously reported . Recent evidence suggests c-Met promotes resistance to EGFR-inhibition by driving ERBB3 (HER3)-dependent PI3 K activation . Dual EGFR-Met inhibition is now proposed as a strategy for overcoming resistance to EGFR-inhibition . METHODS Patients ( pts ) were enrolled in a sequential-cohort dose-escalation trial seeking to define safety , tolerability , pharmacokinetics ( PK ) , and preliminary anti-tumor activity of A in combination with 150 mg daily oral erlotinib ( E ) . Oral A was administered at escalating doses of 120 , 240 , and 360 mg bid . Intra-patient dose escalation was allowed in the absence of dose-limiting toxicity ( DLT ) through 1 cycle of therapy ( 21 days ) . RESULTS 25 pts ( 10 F/15 M ; mean 60.5 yrs ) received EA combination with starting A dose of 120 ( 8 pts ) , 240 ( 4 pts ) , and 360 ( 13 pts ) mg bid . PK data reveal linear kinetics through 360 bid and no evidence of drug-drug
Output:
| Compared with single-agent erlotinib , doublets ( erlotinib plus another targeted agent ) significantly improve ORR and DCR , but not OS , and induce no significance of more frequent and serious AEs .
The benefit-to-risk ratio of doublets in advanced NSCLC may be more favorable than that of single-agent .
The results of this systematic review suggest that patients with advanced NSCLC might benefit from doublet-targeted therapy based on erlotinib compared to erlotinib alone . |
MS213410 | ***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: Young female players in European h and ball have a very high injury incidence , up to 50 injuries per 1000 hours of game . More than half of these injuries happen without any external cause . The aim of the study was to investigate the effect of an intervention programme design ed to reduce the number of injuries in young female players in European h and ball , with special emphasis on injuries in the lower extremities . The programme was created using elite athlete training programmes and those design ed for rehabilitation of injured athletes with functional instability of their ankles and rupture of the anterior cruciate ligament . It included the use of an ankle disk for 10 - 15 min at all practice sessions , for one 10-month season ( August 1995-May 1996 ) . Twenty-two teams participated in the study , and were r and omly assigned to the intervention or control group . Eleven teams with 111 players were r and omised to the intervention group and 11 teams with 126 players to the control group . Data were analysed using a t-test for continuous variables , chi2- analysis and Fisher 's exact test for dichotomous variables and multivariate methods to determine odds-ratios . The results indicated that using the intervention programme decreased the numbers of both traumatic and overuse injuries significantly . The differences in injuries between the groups were 80 % during games and 71 % during practice . In addition , the players in the control group had a 5.9 times higher risk of acquiring an injury than the players in the intervention group Soccer referees participating in large soccer tournaments may develop overuse injuries . In this study the effect of shock absorbing heel inserts in the incidence of soreness was investigated . Forty-eight referees were r and omly selected to wear shock absorbing heel inserts ( SAH ) in the 5 day-tournament , while 43 referees were the control group . A daily question naire inquiring about complaints from the locomotive system was completed for each referee and in case of any soreness they were examined by doctors to document and classify the anatomical site . Calf , thigh , back , achilles tendon and knee were the most common localizations of overuse symptoms . The incidence of soreness in achilles tendon , calf and back were significantly reduced by the use of ( SAH ) inserts Three hundred fifty male recruits were r and omly allocated to either the st and ard recruit training program ( N = 180 ) or substituted a weighted march activity for all running periods in the physical training program ( N = 170 ) . There were no other differences in the formal training program . The incidence of injury was 37.6 and 46.6 % in the walk and run groups , respectively . The rate of injury was 52.9/100 recruits in the walk group and 61.7/100 in the run group . The exposure incidence was 12.8/1,000 hours of physical training in the walk group and 14.9/1,000 hours in the run group . There was no statistically significantly difference in the total number of injured recruits in the two groups ( 64 vs. 85 , chi(2 ) = 2.90 , p = 0.09 , relative risk [ RR ] = 1.24 ) . There were , however , significantly more lower-limb ( 43 vs. 75 , chi(2 ) = 9.77 , p = 0.0018 , RR = 1.65 ) and knee injuries ( 15 vs. 35 , chi(2 ) = 6.54 , p = 0.011 , RR = 2.14 ) in the Run group . Lower-limb injuries constituted 79.8 % of all Run injuries and 61.1 % of all Walk injuries . Injuries in the Run group produced more morbidity , with nearly double the number of days of restriction , hospitalization , and not fit for duty . St and ardized morbidity rates showed an average of 5.4 days of restriction per injury in the Run group and 3.96 days of restriction per injury in the Walk group . Reduction of running distance in the physical training program result ed in significant reductions in both the incidence of lower-limb injury and the overall severity of injury Plantar fasciitis is a common problem in running sports . This study was undertaken to determine whether iontophoresis of dexamethasone in conjunction with other traditional modalities provides more immediate pain relief than traditional modalities alone . Forty affected feet were r and omly assigned to one of two groups . Group I feet were treated with traditional modalities and placebo iontophoresis . Group II feet received the traditional modalities plus iontophoresis of dexamethasone . Both groups were treated six times over 2 weeks . The subjects ' clinical course was assessed using the Maryl and Foot Score . At the conclusion of treatment , Group II patients had significantly greater improvement than Group I patients ( increase on Maryl and Foot Score of 6.8 + /- 5.6 for Group II and 3.1 + /- 4.1 for Group I ) . However , at followup 1 month after completion of treatment there was no significant difference between groups ( increase of 5.6 + /- 8.0 for Group I and 7.4 + /- 6.3 for Group II ) . These results suggest that although traditional modalities alone are ultimately effective , iontophoresis in conjunction with traditional modalities provides immediate reduction in symptoms . Based on these results , iontophoresis of dexamethasone for plantar fasciitis should be considered when more immediate results are needed ( i.e. , performance athletes and active patients The purpose of this intervention study was to prove that increasing flexibility of the hamstring musculotendinous unit would decrease the number of lower extremity overuse injuries that occur in military infantry basic trainees . Two different companies going through basic training at the same time were used . Hamstring flexibility was checked at the beginning and at the end of the 13-week infantry basic training course . The control company ( N 148 ) proceeded through normal basic training . The intervention company ( N 150 ) followed the same program but added three hamstring stretching sessions to their already scheduled fitness program . All subsequent lower extremity overuse injuries were recorded through the troop medical clinic . Hamstring flexibility increased significantly in the intervention group compared with the control group . The number of injuries was also significantly lower in the intervention group . Forty-three injuries occurred in the control group for an incidence rate of 29.1 % , compared with 25 injuries in the intervention group for an incidence rate of 16.7 % . Thus , in this study , the number of lower extremity overuse injuries was significantly lower in infantry basic trainees with increased hamstring flexibility Our prospect i ve study evaluates the use of a knee brace with a silicon patellar support ring as a method of preventing anterior knee pain from developing in young persons undergoing strenuous physical exercise . We studied 60 young athletes , who qualified for a strenu ous physical training course and who had not suffered from anterior knee pain previously . Twenty-seven sub jects were in the brace group and 33 were in the nonbrace control group . The incidence of anterior knee pain syndrome increased with the intensity of exertion as the study progressed ; i.e. , subjects ran 6 km in the 1 st week , gradually increasing each week up to 42 km/week at the 8th week . Yet , there was a significant reduction in the incidence of the syndrome at the end of the study in male athletes who had applied the braces before exercise sessions and in the brace group as a whole , compared with the control group . Prophylactic use of the brace , as described , did not reduce the ability of the athletes who wore braces to improve their physical fitness parameters in response to exercise . These data indicate that the use of a brace may be an effective way to prevent the development of anterior knee pain syndromes in persons participating in strenuous and intensive physical exercise Sedentary individuals , particularly new military recruits , who start a physical training program have a substantial risk of developing an overuse injury of the lower limb . In this study we investigated the effect of neoprene insoles on the incidence of overuse injuries during 9 weeks of basic military training . The experimental group consisted of 237 r and omly selected new recruits , while 1151 recruits were the control group . Insoles were given to the experimental group and compliance was monitored . A panel of doctors documented and classi fied all injuries occurring during the 9 week period . A total of 54 ( 22.8 % ) and 237 ( 31.9 % ) injuries were reported in the experimental and control groups , re spectively . In both groups , the majority of injuries were overuse ( experimental group , 90.7 % ; control group , 86.4 % ) . The mean weekly incidence of total overuse injuries and tibial stress syndrome was significantly lower ( P < 0.05 ) in the experimental group . The mean incidence of stress fractures was lower in the experimental group but not significantly so ( 0.05 < P < 0.1 ) . This study shows that the incidence of total overuse injuries and tibial stress syndrome during 9 weeks of basic military training can be reduced by wearing insoles The purpose of this study was to evaluate the effect of a health education intervention on running injuries . The intervention consisted of information on , and the sub sequent performance of , st and ardized warm-up , cool- down , and stretching exercises . Four hundred twenty- one male recreational runners were matched for age , weekly running distance , and general knowledge of preventing sports injuries . They were r and omly split into an intervention and a control group : 167 control and 159 intervention subjects participated throughout the study . During the 16-week study , both groups kept a daily diary on their running distance and time , and reported all injuries . In addition , the intervention group was asked to note compliance with the st and ardized program . At the end of the study period , knowledge and attitude were again measured . There were 23 injuries in the control group and 26 in the intervention group . Injury incidence for control and intervention sub jects was 4.9 and 5.5 running injuries per 1000 hours , respectively . The intervention was not effective in re ducing the number of running injuries ; it proved signifi cantly effective ( P < 0.05 ) in improving specific knowl edge of warm-up and cool-down techniques in the intervention group . This positive change can perhaps be regarded as a first step on the way to a change of behavior , which may eventually lead to a reduction of running injuries A prospect i ve controlled trial was carried out to determine the usefulness of a viscoelastic polymer insole in prevention of stress fractures and stress reactions of the lower extremities . The subjects were 3,025 US Marine recruits who were followed for 12 weeks of training at Parris Isl and , South Carolina . Polymer and st and ard mesh insoles were systematic ally distributed in boots that were issued to members of odd and even numbered platoons . The most important finding was that an elastic polymer insole with good shock absorbency properties did not prevent stress reactions of bone during a 12-week period of vigorous physical training . To control for the confounding effects of running in running shoes , which occurred for about one and one-half hours per week for the first five weeks , we also examined the association of age of shoes and cost of shoes with injury incidence . A slight trend of increasing stress injuries by increasing age of shoes was observed . However , this trend did not account for the similarity of rates in the two insole groups . In addition , we observed a strong trend of decreasing stress injury rate by history of increasing physical activity , as well as a higher stress injury rate in White compared to Black recruits . The results of the trial were not altered after controlling for these factors . This prospect i ve study confirms previous clinical reports of the association of stress fractures with physical activity history . The clinical application of a shock absorbing insole as a preventive for lower extremity stress reactions is not supported in these uniformly trained recruits . The findings are relevant to civilian population This study investigated effects of ankle dorsiflexion range and pre-exercise calf muscle stretching on relative risk of selected injuries in 1093 male Army recruits undertaking 12 weeks of intensive training . Prior to training , ankle dorsiflexion range was measured and recruits were allocated to stretch and control groups using a quasi-r and om procedure . The stretch group stretched calf muscles under supervision prior to all intense exercise . The control group stretched upper limb muscles instead . Forty-eight injuries were recorded . Survival analysis indicated that ankle dorsiflexion range was a strong predictor of injury ( p = 0.03 ) . Definitive evidence of an effect of stretching on injury risk was not found ( p = 0.76 ) , but the sample size may have been insufficient to detect such an effect PURPOSE This study investigated the effect of muscle stretching during warm-up on the risk of exercise-related injury . METHODS 1538 male army recruits were r and omly allocated to stretch or control groups . During the ensuing 12 wk of training , both groups performed active warm-up exercises before physical training sessions . In addition , the stretch group performed one 20-s static stretch under supervision for each of six major leg muscle groups during every warm-up . The control group did not stretch . RESULTS 333 lower-limb injuries were recorded during the training period , including 214 soft-tissue injuries . There were 158 injuries in the stretch group and 175 in the control group . There was no significant effect of preexercise stretching on all-injuries risk ( hazard ratio [ HR ] = 0.95 , 95 % CI 0.77 - 1.18 ) , soft-tissue injury risk ( HR = 0.83 , 95 % CI 0.63 - 1.09 ) , or bone injury risk ( HR = 1.22 , 95 % CI 0.86 - 1.76 ) . Fitness ( 20-m progressive shuttle run test score ) , age , and enlistment date all significantly predicted injury risk ( P < 0.01 for each ) , but height , weight , and body mass index did not . CONCLUSION A
Output:
| REVIEW ER 'S CONCLUSIONS This review provides some evidence for the effectiveness of the modification of training schedules , but there is insufficient evidence to determine the effectiveness of stretching exercises for major lower limb muscle groups in reducing lower limb soft-tissue running injuries . |
MS213411 | ***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 and methods : Compared to age-matched healthy controls ( n = 55 ) , patients with amyotrophic lateral sclerosis ( ALS ) ( n = 26 ) showed increased oxidative stress as indicated by a significantly increased percentage of oxidized coenzyme Q10 ( % CoQ10 ) in total plasma coenzyme Q10 , a significantly decreased level of plasma uric acid , and a significantly decreased percentage of polyunsaturated fatty acids in total plasma free fatty acids ( FFA ) . Therefore , the efficacy of edaravone , a radical scavenger , in these ALS patients was examined . Results and discussion : Among 26 ALS patients , 17 received edaravone ( 30 mg/day , one to four times a week ) for at least 3 months , and 13 continued for 6 months . Changes in revised ALS functional rating scale ( ALSFRS-R ) were significantly smaller in these patients than in edaravone-untreated ALS patients ( n = 19 ) . Edaravone administration significantly reduced excursions of more than one st and ard deviation from the mean for plasma FFA levels and the contents of palmitoleic and oleic acids , plasma markers of tissue oxidative damage , in the satisfactory progress group ( ΔALSFRS-R ≥ 0 ) as compared to the ingravescent group ( ΔALSFRS-R < −5 ) . Edaravone treatment increased plasma uric acid , suggesting that it is an effective scavenger of peroxynitrite . However , edaravone administration did not decrease % CoQ10 . Therefore , combined treatment with agents such as coenzyme Q10 may further reduce oxidative stress in ALS patients Amyotrophic lateral sclerosis ( ALS ) is a neurodegenerative disease that currently has no cure . At present , the only approved treatment for ALS is Riluzole , a glutamate release blocker that improves life expectancy by 3–6 months . ALS-Endotherapia ( GEMALS ) is a novel therapeutic approach to treat ALS and the aim of the present study was to investigate the potential beneficial effects of this novel treatment . A total of 31 patients with ALS were assessed in the current study . Deceleration of the disease was observed in 83.87 % ( P<0.0001 ) of patients and mean life expectancy was increased by 38 months . Motor functions , including breathing , walking , salivation , speech , swallowing and writing , were also improved in patients treated with GEMALS . The results of the present study demonstrate that long-term treatment with GEMALS has a curative effect in patients with ALS . Furthermore , the overall effectiveness of GEMALS was assessed using the ALS Assessment Question naire . The score improvement was 76.2 and 100 % for men and women , respectively ( P<0.0001 ) , compared with the worldwide reference score . The present study provides a promising basis for the use of GEMALS as a therapeutic treatment for patients with ALS ; however , these results must be confirmed in a double-blinded and r and omized clinical trial The ALS Functional Rating Scale ( ALSFRS ) is a vali date d rating instrument for monitoring the progression of disability in patients with amyotrophic lateral sclerosis ( ALS ) . One weakness of the ALSFRS as originally design ed was that it granted disproportionate weighting to limb and bulbar , as compared to respiratory , dysfunction . We have now vali date d a revised version of the ALSFRS , which incorporates additional assessment s of dyspnea , orthopnea , and the need for ventilatory support . The Revised ALSFRS ( ALSFRS-R ) retains the properties of the original scale and shows strong internal consistency and construct validity . ALSFRS-R scores correlate significantly with quality of life as measured by the Sickness Impact Profile , indicating that the quality of function is a strong determinant of quality of life in ALS Amyotrophic lateral sclerosis ( ALS ) is a rare disease involving selective and progressive degeneration and disappearance of motor neurons . Oxidative stress is believed to contribute to its pathogenesis . We have investigated the efficacy and safety of edaravone , a free radical scavenger previously approved for treatment of acute cerebral infa rct ion , in ALS patients . Within an open trial design , 20 subjects with ALS received either 30 mg ( 5 subjects ) or 60 mg ( 15 subjects ) of edaravone via intravenous drip once per day . Two weeks of administration was followed by a two‐week observation period . This four‐week cycle was repeated six times . The primary endpoint was the change in the revised ALS functional rating scale ( ALSFRS‐R ) score , while the secondary endpoint was 3‐nitrotyrosine ( 3NT ) level in cerebrospinal fluid ( CSF ) . Efficacy was evaluated in the 60 mg group . During the six‐month treatment period , the decline in the ALSFRS‐R score ( 2.3±3.6 points ) was significantly less than that in the six months prior to edaravone administration ( 4.7±2.1 points ) ; the difference between the two was 2.4±3.5 points ( Wilcoxon signed rank test , p = 0.039 ) . In almost all patients , CSF 3NT , a marker for oxidative stress , was markedly reduced to almost undetectable levels at the end of the six‐month treatment period . Data from the present study suggest that edaravone is safe and may delay the progression of functional motor disturbances by reducing oxidative stress in ALS patients Edaravone is a free-radical scavenger , an agent being widely used for cerebral ischemia in Japan . To evaluate its efficacy for possible treatment of amyotrophic lateral sclerosis ( ALS ) , we performed a r and omized blind trial in ALS model mice . After identification of the clinical onset in each female G93A mutant SOD1 transgenic mouse , we intraperitoneally administered multiple doses of edaravone to the mice and observed their motor symptoms . We also counted the number of lumbar motoneurons , determined the 3-nitrotyrosine/tyrosine ratio , and evaluated the abnormal SOD1 aggregation in the spinal cord at the 10th day after the edaravone injection . Edaravone significantly slowed the motor decline of the transgenic mice . The remaining motoneurons were significantly preserved in the higher-dose edaravone-administered group , and the 3-nitrotyrosine/tyrosine ratios were reduced dose-dependently . Intriguingly , the area of abnormal SOD1 deposition in the spinal cord was significantly decreased in the higher-dose edaravone-administered group . Our results indicate that edaravone was effective to slow symptom progression and motor neuron degeneration in the ALS model mice . These favorable actions might be attributable to the yet unidentified mechanism responsible for reducing the deposition of mutant SOD1 OBJECTIVES To test the utility of a new , easy to administer instrument for assessing activities of daily living in patients with amyotrophic lateral sclerosis ( ALS ) , to vali date its accuracy , and to assess its ability to record disease progression in patients with ALS against other functional scales , quantitative isometric muscle testing , and global assessment scales . DESIGN Serial assessment s of patients who presented to four ALS treatment centers in two multicenter studies . PATIENTS Study 1 ( cross-sectional ) evaluated 75 consecutive patients who presented to four ALS treatment centers during a 2-month period . Study 2 ( longitudinal ) evaluated the progression of 53 patients who were enrolled in a multicenter , phase I-II clinical trial of recombinant human ciliary neurotrophic factor for treatment of ALS . OUTCOME MEASURES The ALS Functional Rating Scale ( ALSFRS ) was compared with quantitative myometry and with other measures of daily function in patients with ALS both cross-sectionally and longitudinally . RESULTS The first study of 75 patients evaluated the internal consistency , the test-retest reliability , and the construct validity of the ALSFRS . Internal consistency and test-retest reliability were high . Patient self-rating of upper- and lower-extremity-dependent tasks were highly correlated with measures of upper- and lower-extremity strength , respectively . Thus , the ALSFRS has good construct validity . In the second study , ALSFRS scores declined in t and em with deterioration in motor and pulmonary function , indicating its sensitivity to change . CONCLUSIONS The ALSFRS is a useful instrument for evaluation of functional status and functional change in patients with ALS . Its results are in close agreement with objective measures of muscle strength and pulmonary function . The ALSFRS may be used as a screening measure for entry into clinical trials , as a surrogate measure of function in situations in which muscle strength can not be measured directly , or as an adjunct to myometry Objective : To replicate the beneficial effect of brain-derived neurotrophic factor ( BDNF ) in 1,135 ALS patients in a multicenter trial . Background : In a phase I through II study , BDNF appeared to increase survival and retard loss of pulmonary function in ALS patients . Methods : Patients were r and omized to placebo , or 25 or 100 μg/kg BDNF for 9 months . Results : The study failed to show benefit of BDNF treatment for the primary end points . Survival in patients treated with 25 μg/kg BDNF was identical to placebo , but there was a trend toward increased survival in the 100-μg/kg group . As a whole , survival was better than anticipated when planning the study . The 9-month probability of survival was approximately 85 % across all groups . This diminished the power of the study . Among the 60 % of patients with baseline forced vital capacity of ≤91 % , survival was significantly greater for 100 μg/kg BDNF versus placebo . For the 20 % of patients treated with 100 μg/kg BDNF reporting altered bowel function as an adverse effect of BDNF in the first 2 weeks of dosing , defined as BDNF “ responders , ” 9-month survival was significantly better than for placebo ( 97.5 % versus 85 % ) . Conclusions : Although the primary end point analysis failed to demonstrate a statistically significant survival effect of BDNF in ALS , post hoc analyses showed that those ALS patients with early respiratory impairment and those developing altered bowel function showed statistically significant benefit . Further clinical trials of BDNF using either intrathecal delivery or high-dose subcutaneous administration are in progress Abstract Our objective was to explore the efficacy and safety of edaravone in amyotrophic lateral sclerosis ( ALS ) patients with a Japan ALS severity classification of Grade 3 . In a 24-week , double-blind , r and omized study , 25 patients who met all of the following criteria were enrolled : Japan ALS severity classification Grade 3 ; definite , probable , or probable-laboratory supported ALS ( El Escorial/revised Airlie House ) ; forced vital capacity ( % FVC ) ≥60 % ; duration of disease ≤3 years at consent ; and change in the revised ALS functional rating scale ( ALSFRS-R ) score of –1 to –4 points during the 12-week pre-observation period . Patients received edaravone ( n = 13 ) or placebo ( n = 12 ) for six cycles . The efficacy outcome was change in the ALSFRS-R score . The least-squares mean change in the ALSFRS-R score ± st and ard error during the 24-week treatment was –6.52 ± 1.78 in the edaravone group and –6.00 ± 1.83 in the placebo group ; the difference of –0.52 ± 2.46 was not statistically significant ( p = 0.835 ) . Incidence of adverse events was 92.3 % ( 12/13 ) in the edaravone group and 100.0 % ( 12/12 ) in the placebo group . There was no intergroup difference in the changes in the ALSFRS-R score . The incidences of adverse events were similar in the two groups
Output:
| Conclusion Intravenous edaravone is efficacious in amyotrophic lateral sclerosis patients , with no severe adverse effects . |
MS213412 | ***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: To eluci date the effects of endurance training on circulating irisin levels in young and middle-aged/older adults , and to determine the association between endurance training-induced alteration of irisin and reduction in body fat . Twenty-five healthy young ( age 21 ± 1 years ; 16 men , 9 women ) and 28 healthy middle-aged/older adults ( age 67 ± 8 years ; 12 men , 16 women ) participated in the study . Each age cohort was divided into two groups : the endurance-training group ( 14 young , 14 middle-aged/older ) and the control group . Subjects in the training groups completed an 8-week endurance-training program ( cycling at 60 - 70 % peak oxygen uptake [ V˙O2peak ] for 45 min , 3 days/week ) . Before and after the intervention , we evaluated serum irisin level , V˙O2peak , and body composition . The increase in V˙O2peak in the young and middle-aged/older training groups after the intervention period was significantly greater than those in the young and middle-aged/older control groups ( P < 0.05 ) . Serum irisin level was significantly increased in the middle-aged/older training group after the intervention period ( P < 0.01 ) , but not in the young training group . Furthermore , in the middle-aged/older training group , the endurance training-induced reduction in visceral adipose tissue area was negatively correlated with the change in serum irisin level ( r = −0.54 , P < 0.05 ) . These results suggest a possible role for secreted irisin in the exercise-induced alteration of abdominal visceral fat in middle-aged and older adults Aim /hypothesis Studies have suggested a link between insulin resistance and mitochondrial dysfunction in skeletal muscles . Our primary aim was to investigate the effect of aerobic training on mitochondrial respiration and mitochondrial reactive oxygen species ( ROS ) release in skeletal muscle of obese participants with and without type 2 diabetes . Methods Type 2 diabetic men ( n = 13 ) and control ( n = 14 ) participants matched for age , BMI and physical activity completed 10 weeks of aerobic training . Pre- and post-training muscle biopsies were obtained before a euglycaemic – hyperinsulinaemic clamp and used for measurement of respiratory function and ROS release in isolated mitochondria . Results Training significantly increased insulin sensitivity , maximal oxygen consumption and muscle mitochondrial respiration with no difference between groups . When expressed in relation to a marker of mitochondrial density ( intrinsic mitochondrial respiration ) , training result ed in increased mitochondrial ADP-stimulated respiration ( with NADH-generating substrates ) and decreased respiration without ADP . Intrinsic mitochondrial respiration was not different between groups despite lower insulin sensitivity in type 2 diabetic participants . Mitochondrial ROS release tended to be higher in participants with type 2 diabetes . Conclusions /interpretationAerobic training improves muscle respiration and intrinsic mitochondrial respiration in untrained obese participants with and without type 2 diabetes . These adaptations demonstrate an increased metabolic fitness , but do not seem to be directly related to training-induced changes in insulin sensitivity OBJECTIVE Exercise twice every other day has been shown to lead to increasing peroxisome proliferator receptor γ coactivator-1α ( PGC-1α ) expression ( up-stream factor of irisin ) via lowered muscle glycogen level during second of exercise compared with exercise once daily . This study determined the influence of 4weeks of sprint training ( training once daily vs. twice every other day ) on the serum irisin concentration . MATERIAL S AND METHODS Twenty healthy males ( 20.9±1.3years ) were assigned r and omly to either the SINGLE or REPEATED group ( n=10 per group ) . The subjects in the SINGLE group participated in a sprint training session once daily ( 5days per week ) , whereas those in the REPEATED group performed two consecutive training sessions on the same day with a 1-h rest between sessions ( 2 - 3days per week ) . Both groups completed 20 training sessions over 4weeks . Each training session consisted of three consecutive 30-s maximal pedaling exercises with a 10-min rest between sets . Blood sample s were collected before and after training period ( 48h after completing the last training session ) . RESULTS The serum irisin concentration decreased significantly after training in each group ( SINGLE , 338.5±77.8 to 207.6±64.6ng/mL ; REPEATED , 329.5±83.9 to 234.2±72.8ng/mL , p<0.05 ) . The plasma interleukin-6 ( IL-6 ) concentration tended to be lower after training in both groups ( main effect for period , p=0.054 ) . However , there was no significant difference in the serum irisin or plasma IL-6 concentration between groups after training . The serum high-molecular-weight adiponectin concentration did not change significantly after training in either group . CONCLUSION Sprint training for 4weeks significantly decreased the resting serum irisin concentration , despite different training programs ( training once daily vs. twice every other day ) CONTEXT The myokine irisin may increase energy expenditure and affect metabolism . OBJECTIVE The objective of the study was to eluci date predictors of irisin and study whether circulating irisin may have day-night rhythm in humans . DESIGN This was an observational , cross-sectional study with an additional 24-hour prospect i ve observational arm ( day-night rhythm sub study ) and two prospect i ve interventional arms ( mixed meal sub study and exercise sub study ) . SETTING The study was conducted at the Hellenic Military School of Medicine ( Thessaloniki , Greece ) . PATIENTS AND INTERVENTIONS One hundred twenty-two healthy , young individuals were subjected to anthropometric and body composition measurements , and their eating and exercise behavior profiles were assessed with vali date d question naires . Subgroups were subjected to day-night rhythm , st and ardized meal ingestion , and 30-minute aerobic exercise studies . MAIN OUTCOME MEASURES Circulating irisin levels were measured . RESULTS Ιrisin levels were lower in males than females ( P = .02 ) after adjustment for lean body mass , which was its major determinant . Irisin levels followed a day-night rhythm ( P < .001 ) with peak at 9:00 pm . Irisin levels were increased at the end of exercise ( 84.1 ± 10.0 vs 105.8 ± 14.3 ng/mL ; P < .001 ) . Irisin levels were not affected by intake of a st and ardized meal and were not associated with caloric intake or diet quality . CONCLUSIONS In healthy , young individuals , circulating irisin displays a day-night rhythm , is correlated with lean body mass , and increases acutely after exercise RATIONALE The newly discovered myokine irisin has been proposed to affect obesity and metabolism by promoting browning of white adipose tissue . However , clinical and functional studies on the association of irisin with obesity , muscle mass , and metabolic status remain controversial . Here we assessed the effect of 4 distinct exercise regimens on serum irisin levels in children and young adults and systematic ally evaluated the influence of diurnal rhythm , anthropometric and metabolic parameters , and exercise on irisin . RESULTS Serum irisin levels did not show diurnal variations , nor were they affected by meal intake or defined glucose load during oral glucose tolerance testing . Irisin levels decreased with age . In adults , irisin levels were higher in men than in women , and obese subjects had significantly higher levels than lean control subjects . Irisin levels were closely correlated with muscle-associated bioimpedance parameters such as fat-free mass and body cell mass . Of the 4 exercise regimens that differed in duration and intensity , we identified a clear and immediate increase in serum irisin levels after acute strenuous exercise ( cycling ergometry ) and a 30-minute bout of intensive exercise in children and young adults , whereas longer ( 6 weeks ) or chronic ( 1 year ) increases in physical activity did not affect irisin levels . SUMMARY We show that irisin levels are affected by age , sex , obesity , and particularly muscle mass , whereas diurnal rhythm and meals do not contribute to the variation in irisin levels . Short bouts of intensive exercise but not long-term elevations in physical activity , acutely and transiently increase serum irisin levels in children and adults
Output:
| We found a contrast between st and ardised review methods and accuracy of the measurements used . |
MS213413 | ***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 The aim of this study was to compare the effects of isometric training performed with progressive versus rapid rate of contraction on the knee extensor neuromuscular properties over a 7-wk period . METHODS Sixteen healthy male subjects trained quadriceps femoris muscle in a leg extension machine three times a week during 7 wk . The training sessions consisted of six sets of six maximal isometric contractions . A first group trained by performing progressive contractions lasting 4 s , whereas a second group performed contractions with a rapid rate of contraction ( i.e. , ballistic contractions ) lasting about 1 s. RESULTS Both groups significantly increased the isometric and isokinetic voluntary torque , and the respective absolute or relative gains were comparable . Isometric training performed with progressive rate of contraction affected the evoked action potential ( M wave ) of the vastus lateralis muscle and not the related twitch properties . On the other h and , the isometric training completed with ballistic contractions significantly modified the twitch contractile properties of the knee extensors and not the associated M waves of both vastus medialis and vastus lateralis . CONCLUSION Knee extensors adapted specifically their neuromuscular properties to the type of rate of contraction performed during 7-wk isometric resistance training . Progressive isometric contractions produced modifications of the nervous system at peripheral level ( i.e. , muscle membrane electrical activity ) , whereas ballistic isometric contractions affected the knee extensor contractile muscle properties ( i.e. , excitation-contraction coupling ) INTRODUCTION We used transcranial magnetic stimulation ( TMS ) to investigate 3 weeks of unilateral leg strength training on ipsilateral motor cortex ( iM1 ) excitability , and short-latency intracortical inhibition ( SICI ) . METHODS Right leg dominant participants ( n = 14 ) were r and omly divided into either a strength training ( ST ) or control group . The ST group completed 9 training sessions ( 4 sets of 6 to 8 repetitions of single right leg squats ) . RESULTS We observed a 41 % increase in right leg strength , and a 35 % increase in strength of the untrained left leg ( P < 0.01 ) . There was a significant increase in motor evoked potential ( MEP ) amplitude recruitment curve for the untrained left leg ( P < 0.01 ) . SICI of the iM1 decreased by 21 % for the untrained left leg ( P < 0.01 ) . CONCLUSIONS The findings provide evidence for corticomotor adaptation for unilateral leg strength training within the iM1 that is modulated by changes in interhemispheric inhibition Abstract The present study investigated the effects of different intensities of resistance training ( RT ) on elbow flexion and leg press one-repetition maximum ( 1RM ) and muscle cross-sectional area ( CSA ) . Thirty men volunteered to participate in an RT programme , performed twice a week for 12 weeks . The study employed a within-subject design , in which one leg and arm trained at 20 % 1RM ( G20 ) and the contralateral limb was r and omly assigned to one of the three conditions : 40 % ( G40 ) ; 60 % ( G60 ) , and 80 % 1RM ( G80 ) . The G20 started RT session with three sets to failure . After G20 training , the number of sets was adjusted for the other contralateral limb conditions with volume-matched . CSA and 1RM were assessed at pre , post-6 weeks , and post-12 weeks . There was time effect for CSA for the vastus lateralis ( VL ) ( 8.9 % , 20.5 % , 20.4 % , and 19.5 % ) and elbow flexors ( EF ) ( 11.4 % , 25.3 % , 25.1 % , and 25 % ) in G20 , G40 , G60 , and G80 , respectively ( p > .05 ) . G80 showed higher CSA than G20 for VL ( 19.5 % vs. 8.9 % ) and EF ( 25 % vs. 11.4 % ) at post-12 weeks ( p < .05 ) . There was time effect for elbow flexion and unilateral leg press strength for all groups post-12 weeks ( p < .05 ) . However , the magnitude of increase was higher in G60 and G80 . In conclusion , when low to high intensities of RT are performed with volume-matched , all intensities were effective for increasing muscle strength and size ; however , 20 % 1RM was suboptimal in this regard , and only the heavier RT intensity ( 80 % 1RM ) was shown superior for increasing strength and CSA compared to low intensities Objective To assess whether three-dimensional imaging of the Achilles tendon by ultrasonographic tissue characterisation ( UTC ) can differentiate between symptomatic and asymptomatic tendons . Design Case-control study . Setting Sports Medical Department of the Hague Medical Centre . Patients Twenty-six tendons from patients with chronic midportion Achilles tendinopathy were included . The “ matched ” control group consisted of 26 asymptomatic tendons . Interventions Symptomatic and asymptomatic tendons were scanned using the UTC procedure . One research er performed the ultrasonographic data collection . These blinded data were r and omised , and outcome measures were determined by two independent observers . Main outcome measurements The raw ultrasonographic images were analysed with a custom design ed algorithm that quantifies the three-dimensional stability of echo patterns , qua intensity and distribution over contiguous transverse images . This threedimensional stability was related to tendon structure in previous studies . UTC categorises four different echotypes that represent ( I ) highly stable ; ( II ) medium stable ; ( III ) highly variable and ( IV ) constantly low intensity and variable distribution . The percentages of echo-types were calculated , and the maximum tendon thickness was measured . Finally , the inter-observer reliability of UTC was determined . Results Symptomatic tendons showed less pixels in echo-types I and II than asymptomatic tendons ( 51.5 % vs 76.6 % , p<0.001 ) , thus less three-dimensional stability of the echo pattern . The mean maximum tendon thickness was 9.2 mm in the symptomatic group and 6.8 mm in the asymptomatic group ( p<0.001 ) . The Intraclass Correlation Coefficient ( ICC ) for the interobserver reliability of determining the echo-types I+II was 0.95 . The ICC for tendon thickness was 0.84 . Conclusion UTC can quantitatively evaluate tendon structure and thereby discriminate symptomatic and asymptomatic tendons . As such , UTC might be useful to monitor treatment protocol Objective : This study aim ed to compare the immediate analgesic effects of 2 resistance programs in in-season athletes with patellar tendinopathy ( PT ) . Resistance training is noninvasive , a principle stimulus for corticospinal and neuromuscular adaptation , and may be analgesic . Design : Within-season r and omized clinical trial . Data analysis was conducted blinded to group . Setting : Subelite volleyball and basketball competitions . Participants : Twenty jumping athletes aged more than 16 years , participating in games/trainings 3 times per week with clinical ly diagnosed PT . Interventions : Two quadriceps resistance protocol s were compared ; ( 1 ) isometric leg extension holds at 60 degrees knee flexion ( 80 % of their maximal voluntary isometric contraction ) or ( 2 ) isotonic leg extension ( at 80 % of their 8 repetition maximum ) 4 times per week for 4 weeks . Time under load and rest between sets was matched between groups . Main Outcome Measures : ( 1 ) Pain ( 0 - 10 numerical rating score ) during single leg decline squat ( SLDS ) , measured preintervention and postintervention sessions . ( 2 ) VISA-P , a question naire about tendon pain and function , completed at baseline and after 4 weeks . Results : Twenty athletes with PT ( 18 men , mean 22.5 ± 4.7 years ) participated ( isotonic n = 10 , isometric n = 10 ) . Baseline median SLDS pain was 5/10 for both groups ( isotonic range 1 - 8 , isometric range 2 - 8 ) . Isometric contractions produced significantly greater immediate analgesia ( P < 0.002 ) . Week one analgesic response positively correlated with improvements in VISA-P at 4 weeks ( r2 = 0.64 ) . Conclusions : Both protocol s appear efficacious for in-season athletes to reduce pain , however , isometric contractions demonstrated significantly greater immediate analgesia throughout the 4-week trial . Greater analgesia may increase the ability to load or perform Abstract The eccentric contraction mode was proposed to be the primary stimulus for optimum angle ( angle at which peak torque occurs ) shift . However , the training range of motion ( or muscle excursion range ) could be a stimulus as important . The aim of this study was to assess the influence of the training range of motion stimulus on the hamstring optimum length . It was hypothesised that performing a single set of concentric contractions beyond optimal length ( seated at 80 ° of hip flexion ) would lead to an immediate shift of the optimum angle to longer muscle length while performing it below ( supine at 0 ° of hip flexion ) would not provide any shift . Eleven male participants were assessed on an isokinetic dynamometer . In both positions , the test consisted of 30 consecutive knee flexions at 4.19 rad · s−1 . The optimum angle was significantly shifted by ∼15 ° in the direction of longer muscle length after the contractions at 80 ° of hip flexion , while a non-significant shift of 3 ° was found at 0 ° . The hamstring fatigability was not influenced by the hip position . It was concluded that the training range of motion seems to be a relevant stimulus for shifting the optimum angle to longer muscle length . Moreover , fatigue appears as a mechanism partly responsible for the observed shift BACKGROUND AND PURPOSE The purpose of this study was to examine the effect of isometric training of the quadriceps femoris muscles , at different joint angles , on torque production and electromyographic ( EMG ) activity . SUBJECTS One hundred seven women were r and omly assigned to one of four groups . Three groups trained with isometric contractions three times per week at a knee flexion angle of 30 , 60 , or 90 degrees . The fourth group , which served as a control , did not exercise . METHODS Isometric torque was measured using a dynamometer , and EMG activity was measured using a multichannel EMG system . Measurements were obtained during maximal isometric contraction of the quadriceps femoris muscles at 15-degree increments from 15 to 105 degrees of knee flexion . Measurements were taken before and after 8 weeks of training . RESULTS Following isometric exercise , increased torque and EMG activity occurred not only at the angle at which subjects exercised , but also at angles in the range of motion at which exercise did occur . Further analyses indicated that exercising in the lengthened position for the quadriceps femoris muscles ( 90 degrees of knee flexion ) produced increased torque across all angles measured and appeared to be the more effective position for transferring strength and EMG activity to adjacent angles following isometric training as compared with the shorter positions of the muscle ( 30 degrees and 60 degrees of knee flexion ) . CONCLUSION AND DISCUSSION These findings suggest that an efficient method for increasing isometric knee extension torque and EMG activity throughout the entire range of motion is to exercise with the quadriceps femoris muscles in the lengthened position Background Few interventions reduce patellar tendinopathy ( PT ) pain in the short term . Eccentric exercises are painful and have limited effectiveness during the competitive season . Isometric and isotonic muscle contractions may have an immediate effect on PT pain . Methods This single-blinded , r and omised cross-over study compared immediate and 45 min effects following a bout of isometric and isotonic muscle contractions . Outcome measures were PT pain during the single-leg decline squat ( SLDS , 0–10 ) , quadriceps strength on maximal voluntary isometric contraction ( MVIC ) , and measures of corticospinal excitability and inhibition . Data were analysed using a split-plot in time-repeated measures analysis of variance ( ANOVA ) . Results 6 volleyball players with PT participated . Condition effects were detected with greater pain relief immediately from isometric contractions : isometric contractions reduced SLDS ( mean±SD ) from 7.0±2.04 to 0.17±0.41 , and isotonic contractions reduced SLDS ( mean±SD ) from 6.33±2.80 to 3.75±3.28 ( p<0.001 ) . Isometric contractions released cortical inhibition ( ratio mean±SD ) from 27.53%±8.30 to 54.95%±5.47 , but isotonic contractions had no significant effect on inhibition ( pre 30.26±3.89 , post 31.92±4.67 ; p=0.004 ) . Condition by time analysis showed pain reduction was sustained at 45 min postisometric but not isotonic condition ( p<0.001 ) . The mean reduction in pain scores postisometric was 6.8/10 compared with 2.6/10 postisotonic . MVIC increased significantly following the isometric condition by 18.7±7.8 % , and was significantly higher than baseline ( p<0.001 ) and isotonic condition ( p<0.001 ) , and at 45 min ( p<0.001 ) . Conclusions A single resistance training bout of isometric contractions reduced tendon pain immediately for at least 45 min postintervention and increased MVIC . The reduction in pain was paralleled by a reduction in cortical inhibition , providing insight into potential mechanisms . Isometric contractions can be completed without pain for people with PT . The clinical implication s are that isometric muscle contra
Output:
| Substantial improvements in muscular hypertrophy and maximal force production were reported regardless of training intensity .
High-intensity ( ≥70 % ) contractions are required for improving tendon structure and function .
Additionally , long muscle length training results in greater transference to dynamic performance .
Despite relatively few studies meeting the inclusion criteria , this review provides practitioners with insight into which isometric training variables ( eg , joint angle , intensity , intent ) to manipulate to achieve desired morphological and neuromuscular adaptations |
MS213414 | ***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: Some people with phenylketonuria who were born before screening began were never treated and are still alive . Here we report that far fewer people with untreated phenylketonuria were detected than are thought to exist ( about 2000 ) . The majority of those traced had high support needs , challenging behaviour and other symptoms of phenylketonuria . No significant differences were found between those who had or had not tried the phenylalanine-restricted diet . A r and omised controlled trial is required to examine the effect of trying the low-phenylalanine diet for people with untreated phenylketonuria Concerns about the psychosocial risk of adults with early-treated phenylketonuria ( ETPKU ) are predicated on four sources of scientific data : ( 1 ) consistent documentation of increased behavioural risk in children with ETPKU ; ( 2 ) recent evidence of neurocognitive impairment in adults with ETPKU ; ( 3 ) reports of neuroimaging abnormalities in adults with ETPKU ; and ( 4 ) preliminary evidence of increased rates of psychiatric disturbance in this population . We studied the psychosocial adjustment of 25 patients , aged 18 years and older , with ETPKU . On most pscyhosocial outcome measures , patients were indistinguishable from 15 sibling controls . However , on a self-report inventory of psychiatric symptoms , 20 % of the patients demonstrated significant morbidity . Psychosocial outcome of these patients was unrelated to concurrent or historical biological dietary disease factors , unlike neurocognitive outcome . A strong relationship was demonstrated , however , between neurocognitive measures and psychosocial morbidity . These findings indicate that a significant minority of patients with ETPKU develop psychosocial difficulties with multiple clinical elevations on a psychiatric inventory . However , most adults with ETPKU cope with the challenges of young adulthood with the same degree of success as their unaffected siblings . Neuropsychological surveillance during childhood and adolescence is important in identifying patients at risk for both neurocognitive and psychosocial morbidity Recent studies indicate that individual blood – brain transport characteristics of phenylalanine may lead to different clinical outcomes in phenylketonuria ( PKU ) patients in spite of comparable dietary control . To check these preliminary data , we investigated four pairs of siblings with classical PKU ( and identical genotype ) using in vivo nuclear magnetic resonance spectroscopy in the course of an oral phenylalanine load ( 100 mg/kg body weight ) . Patients ' brain phenylalanine concentrations were different in spite of similar blood levels . Interindividual variations of the apparent transport Michaelis constant , Kt , app , ranged from 0.10 to 0.84 mmol/L. The ratio of the maximal transport velocity , Tmax , over the intracerebral consumption rate , Vmet , varied between 2.61 and 14.0 . Siblings with lower values for Kt , app , higher values for Tmax/Vmet , and higher concurrent brain phenylalanine levels showed a lower IQ and a higher degree of cerebral white matter abnormalities . The results indicate that blood – brain barrier transport characteristics and the result ant brain phenylalanine levels are causative factors for the individual clinical outcome in PKU Background The strict and dem and ing dietary treatment and mild cognitive abnormalities seen in PKU treated from a young age can be expected to affect the health-related quality of life ( HRQoL ) of patients and their families . Our aim was to describe the HRQoL of patients with PKU from a large international study , using generic HRQoL measures and an innovative PKU-specific HRQoL question naire ( PKU-QOL ) . Analyses were exploratory , performed post-hoc on data collected primarily to vali date the PKU-QOL . Methods A multicentre , prospect i ve , non-interventional , observational study conducted in France , Germany , Italy , The Netherl and s , Spain , Turkey and the UK . Patients diagnosed with PKU aged ≥9 years old and treated with a Phe-restricted diet and /or Phe-free amino acid protein supplements and /or pharmacological therapy were included in the study ; parents of at least one patient with PKU aged < 18 years were also included . HRQoL was assessed by generic measures ( Pediatric Quality -of-Life Inventory ; Medical Outcome Survey 36 item Short Form ; Child Health Question naire 28 item Parent Form ) and the newly developed PKU-QOL . Mean generic domain scores were interpreted using published reference values from the general population . PKU-QOL domain scores were described overall and in different subgroups of patients defined according to severity of PKU , overall assessment of patient ’s health status by the investigator and treatment with tetrahydrobiopterin ( BH4 ) . Results Data from 559 subjects were analysed : 306 patients ( 92 children , 110 adolescents , 104 adults ) and 253 parents . Mean domain scores of generic measures in the study were comparable to the general population . The highest PKU-QOL impact scores ( indicating greater impact ) were for emotional impact of PKU , anxiety about blood Phe levels , guilt regarding poor adherence to dietary restrictions or Phe-free amino acid supplement intake and anxiety regarding blood Phe levels during pregnancy . Patients with mild/moderate PKU and those receiving BH4 reported lower practical and emotional impacts of the diet and Phe-free amino acid supplement intake . Conclusion Patients with PKU showed good HRQoL in the study , both with the generic and PKU-specific measures . Negative impacts of PKU on a patient ’s life , including the emotional impact of PKU and its management , was delineated by the PKU-QOLs across all age groups Background : Although early diagnosis and treatment in phenylketonuria ( PKU ) leads to excellent outcomes , a population of adults born before the introduction of newborn screening exists . They can have severe intellectual disabilities and behavioural problems , and are often dependent on full-time carers . Anecdotal evidence suggests that a diet that lowers blood phenylalanine concentration can have significant benefits upon behaviour . Methods : A prospect i ve double-blind r and omised placebo-controlled crossover trial of phenylalanine-restricted diet was performed in a group of 34 adults ( aged 21–61 years , median 49 ) with late diagnosed PKU with severe challenging behaviour . Results : Only 17 completed the 60 week study : seven withdrew before the end of the baseline period ; five withdrew during the first diet period ; five withdrew during the second diet period ( after moving into placebo phase ) . The mean ( SD ) blood phenylalanine was 1570 ( 222 ) μmol/l during baseline , 553(158 ) μmol/l during the active phase and 1444 ( 255 ) μmol/l during the placebo phase . In the 22 participants exposed to both active and placebo phases , no differences were demonstrated in behaviour assessed by the Aberrant Behavior Checklist and Vinel and Adaptive Behavior Scales , behaviour diaries or on video analysis of direct observations . However , 76 % of carers ’ comments were scored as positive during the active phase , compared with 54 % during the placebo phase ( χ2 = 38.06 , p<0.001 ) . Conclusions : There are significant challenges in study ing people with intellectual disabilities and considerable difficulties in instituting phenylalanine-restricted diet in this population . However , if attempted , there are potential benefits to quality of life for the individuals with PKU and their carers The main debate in the treatment of Phenylketonuria ( PKU ) is whether adult patients need the strict phenylalanine (Phe)-restricted diet . Physicians and patients lack evidence -based guidelines to help them make well-informed choices . We have carried out the first r and omised double-blind placebo-controlled trial into the effects of short-term elevation of Phe levels on neuropsychological functions and mood of adults with PKU . Nine continuously treated adults with PKU underwent two 4-week supplementation periods : one with Phe , mimicking normal dietary intake , and one with placebo in r and omly allocated order via a r and omisation coding list in a double-blind cross-over design . A set of neuropsychological tests ( Amsterdam Neuropsychological Tasks ) was administered at the end of each study period . In addition , patients and for each patient a friend or relative , completed weekly Profile of Mood States ( POMS ) question naires , evaluating the patients ’ mood . Phe levels were measured twice weekly . Mean plasma Phe levels were significantly higher during Phe supplementation compared with placebo ( p = 0.008 ) . Neuropsychological tests demonstrated an impairment in sustained attention during Phe supplementation ( p = 0.029 ) . Both patients and their friend or relative reported lower scores on the POMS question naires during Phe supplementation ( p = 0.017 and p = 0.040 , respectively ) . High plasma Phe levels have a direct negative effect on both sustained attention and on mood in adult patients with PKU . A Phe-restricted “ diet for life ” might be an advisable option for many Background The aim of our study was to develop and vali date the first set of PKU-specific Health-related Quality of Life ( HRQoL ) question naires that : 1 ) were developed for patients with PKU and their parents , 2 ) cover the physical , emotional , and social impacts of PKU and its treatment on patients ’ lives , 3 ) are age specific ( Child PKU-QOL , Adolescent PKU-QOL , Adult PKU-QOL ) , 4 ) enable the evaluation of the HRQoL of children by their parents ( Parent PKU-QOL ) , and 5 ) have been cross-culturally adapted for use in seven countries ( i.e. France , Germany , Italy , The Netherl and s , Spain , Turkey and the UK ) . Methods The PKU-QOL question naires were developed according to reference methods including patients ’ , parents ’ and healthcare professionals ’ interviews ; testing in a pilot study ( qualitative step in six countries ) , and linguistic validation of the finalised pilot versions in Turkish . For finalisation and psychometric validation , the pilot versions were included in a multicentre , prospect i ve , non-interventional , observational study conducted in 34 sites in France , Germany , Italy , The Netherl and s , Spain , Turkey and the UK . Iterative multi-trait analyses were conducted . Psychometric properties were assessed ( concurrent and clinical validity , internal consistency reliability and test-retest reliability ) . Results Data from 559 subjects ( 306 patients , 253 parents ) were analysed . After finalisation , the PKU-QOL question naires included 40 items ( Child PKU-QOL ) , 58 items ( Adolescent PKU-QOL ) , 65 items ( Adult PKU-QOL ) and 54 items ( Parent PKU-QOL ) , distributed in four modules : PKU symptoms , PKU in general , administration of Phe-free protein supplements and dietary protein restriction . The measurement properties of the Adolescent , Adult and Parent PKU-QOL question naires were overall fairly satisfactory , but weaker for the Child question naire . Conclusions The four PKU-QOL question naires developed for different ages ( Child PKU-QOL , Adolescent PKU-QOL , Adult PKU-QOL ) , and for parents of children with PKU ( Parent PKU-QOL ) are valid and reliable instruments for assessing the multifaceted impact of PKU on patients of different age groups ( children , adolescents and adults ) and their parents , and are available for use in seven countries . They are very promising tools to explore how patients ’ perceptions evolve with age , to increase knowledge of the impact of PKU on patients and parents in different countries , and to help monitor the effect of therapeutic strategies During 1967–1983 , the Maternal and Child Health Division of the Public Health Services funded a collaborative study of 211 newborn infants identified on newborn screening as having phenylketonuria ( PKU ) . Subsequently , financial support was provided by the National Institute of Child Health and Human Development ( NICHD ) . The infants were treated with a phenylalanine (Phe)-restricted diet to age 6 years and then r and omized either to continue the diet or to discontinue dietary treatment altogether . One hundred and twenty-five of the 211 children were then followed until 10 years of age . In 1998 , NICHD scheduled a Consensus Development Conference on Phenylketonuria and initiated a study to follow up the participants from the original Collaborative Study to evaluate their present medical , nutritional , psychological , and socioeconomic status . Fourteen of the original clinics ( 1967–1983 ) participated in the Follow-up Study effort . Each clinic director was provided with a list of PKU subjects who had completed the original study ( 1967–1983 ) , and was asked to evaluate as many as possible using a uniform protocol and data collection forms . In a subset of cases , magnetic resonance imaging and spectroscopy ( MRI/MRS ) were performed to study brain Phe concentrations . The medical evaluations revealed that the subjects who maintained a phenylalanine-restricted diet reported fewer problems than the diet discontinuers , who had an increased rate of eczema , asthma , mental disorders , headache , hyperactivity and hypoactivity . Psychological data showed that lower intellectual and achievement test scores were associated with dietary discontinuation and with higher childhood and adult blood Phe concentrations . Abnormal MRI results were associated with higher brain Phe concentrations . Early dietary discontinuation for subjects with PKU is associated with poorer outcomes not only in intellectual ability , but also in achievement test scores and increased rates of medical and behavioural problems OBJECTIVE To determine psychiatric disorders in patients with phenylketonuria ( PKU ) and to test whether biochemical control , intellectual functioning , white matter abnormalities visible on magnetic resonance imaging ( MRI ) , and /or style of parenting influence psychop
Output:
| The overall quality of life ( QoL ) of ETPKU adults was good or comparable to control population s , and there was no evidence for a significant incidence of psychiatric disease or social difficulties .
Neuroimaging revealed that brain abnormalities are present in ETPKU adults , but their clinical significance remains unclear .
Generally , intelligence quotient ( IQ ) appears normal but specific deficits in neuropsychological and social functioning were reported in early-treated adults compared with healthy individuals . |
MS213415 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size & NA ; There is uncertainty over whether the patient group in which acute pain studies are conducted ( pain model ) has any influence on the estimate of analgesic efficacy . Data from four recently up date d systematic review s of aspirin 600/650 mg , paracetamol 600/650 mg , paracetamol 1000 mg and ibuprofen 400 mg were used to investigate the influence of pain model . Area under the pain relief versus time curve equivalent to at least 50 % maximum pain relief over 6 h was used as the outcome measure . Event rates with treatment and placebo , and relative benefit ( RB ) and number needed to treat ( NNT ) were used as outputs from the meta‐analyses . The event rate with placebo was systematic ally statistically lower for dental than postsurgical pain for all four treatments . Event rates with analgesics , RB and NNT were infrequently different between the pain models . Systematic difference in the estimate of analgesic efficacy between dental and postsurgical pain models remains unproven , and , on balance , no major difference is likely Abstract A previously established relationship for deriving dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics has been tested using an independent data set . Individual patient information from 18 RCTs of parallel‐group design in acute postoperative pain ( after abdominal , gynaecological and oral surgery ) was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with > 50%maxTOTPAR for the different treatments . The relationship between the measures was investigated in 85 treatments with over 3400 patients . In 80 of 85 treatments ( 94 % ) agreement between calculated and actual number of patients with > 50%maxTOTPAR was within four patients per treatment and in 72 ( 85 % ) was within three ( average of 40 patients per treatment , range 21–58 patients ) . Summing the positive and negative differences between actual and calculated numbers of patients with > 50%maxTOTPAR gave an average difference of 0.30 patients per treatment arm . Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events , such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data in acute pain studies enables data published as means to be used for quantitative systematic review s which require data in dichotomous form & NA ; Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events — such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data , at least in acute pain models , indicates that more meaningful overviews or meta‐ analysis may be possible . This study investigated the relationship between continuous and dichotomous analgesic measures in a set of individual patient data , and then used that relationship to derive dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics . Individual patient information from 13 RCTs of parallel‐group and crossover design in acute postoperative pain was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with greater than 50 % pain relief ( > 50%maxTOTPAR ) for the different treatments . The relationship between the measures was investigated in 45 actual treatments and 10 000 treatments simulated using the underlying actual distribution ; 1283 patients had 45 separate treatments . Mean % maxTOTPAR correlated with the proportion of patients with > 50%maxTOTPAR ( r2 = 0.90 ) . The relationship calculated from all the 45 treatments predicted to within three patients the number of patients with more than 50 % pain relief in 42 of 45 treatments , and 98.8 % of 10 000 simulated treatments . For seven effective treatments , actual numbers‐needed‐to‐treat ( NNT ) to achieve > 50%maxTOTPAR compared with placebo were very similar to those derived from calculated data & NA ; A data base of r and omised clinical trials ( RCTs ) in pain research published from 1950 to 1990 was created following an extensive literature search . By applying a refined MEDLINE search strategy from 1966 to 1990 and by h and ‐ search ing more than 1 000 000 pages of a total of 40 biomedical journals published during the period 1950–1990 , more than 8000 RCTs were identified . The RCTs were published in more than 800 journals and over 85 % appeared between 1976 and 1990 . If the trend of the last 15 years persists , a total of more than 15 000 RCTs will be published in pain relief by the year 2000 . A detailed description of methods to ensure efficient use of re sources during the identification , retrieval and management of the information in pain relief and other fields is given . Emphasis is made on the importance of refining MEDLINE search strategies , on the use of volunteers to h and ‐ search journals and on careful monitoring of each of the steps of the process . The potential uses of the data base to guide clinical and research decisions are discussed Abstract One way to ensure adequate sensitivity for analgesic trials is to test the intervention on patients who have established pain of moderate to severe intensity . The usual criterion is at least moderate pain on a categorical pain intensity scale . When visual analogue scales ( VAS ) are the only pain measure in trials we need to know what point on a VAS represents moderate pain , so that these trials can be included in meta‐ analysis when baseline pain of at least moderate intensity is an inclusion criterion . To investigate this we used individual patient data from 1080 patients from r and omised controlled trials of various analgesics . Baseline pain was measured using a 4‐point categorical pain intensity scale and a pain intensity VAS under identical conditions . The distribution of the VAS scores was examined for 736 patients reporting moderate pain and for 344 reporting severe pain . The VAS scores corresponding to moderate or severe pain were also examined by gender . Baseline VAS scores recorded by patients reporting moderate pain were significantly different from those of patients reporting severe pain . Of the patients reporting moderate pain 85 % scored over 30 mm on the corresponding VAS , with a mean score of 49 mm . For those reporting severe pain 85 % scored over 54 mm with a mean score of 75 mm . There was no difference between the corresponding VAS scores of men and women . Our results indicate that if a patient records a baseline VAS score in excess of 30 mm they would probably have recorded at least moderate pain on a 4‐point categorical scale
Output:
| The expected equivalent efficacy with a half dose of dexketoprofen compared to ketoprofen was not demonstrated .
Adverse events were uncommon with both drugs , and not significantly different from placebo .
Both drugs were well tolerated in single doses |
MS213416 | ***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 Adequate fruit and vegetable ( F&V ) intake is important for disease prevention . Yet , most Americans , especially low-income and racial/ethnic minorities , do not eat adequate amounts . These disparities are partly attributable to food environments in low-income neighborhoods where residents often have limited access to affordable , healthful food and easy access to inexpensive , unhealthful foods . Increasing access to affordable healthful food in underserved neighborhoods through mobile markets is a promising , year-round strategy for improving dietary behaviors and reducing F&V intake disparities . However , to date , there have been no r and omized controlled trials study ing their effectiveness . The objective of the ‘ Live Well , Viva Bien ’ ( LWVB ) cluster r and omized controlled trial is to evaluate the efficacy of a multicomponent mobile market intervention at increasing F&V intake among residents of subsidized housing complexes . Methods / Design One housing complex served as a pilot site for the intervention group and the remaining 14 demographically-matched sites were r and omized into either the intervention or control group . The intervention group received bimonthly , discount , mobile , fresh F&V markets in conjunction with a nutrition education intervention ( two F&V campaigns , newsletters , DVDs and cooking demonstrations ) for 12 months . The control group received physical activity and stress reduction interventions . Outcome measures include F&V intake ( measured by two vali date d F&V screeners at baseline , six-month and twelve-months ) along with potential psychosocial mediating variables . Extensive quantitative and qualitative process evaluation was also conducted throughout the study . Discussion Modifying neighborhood food environments in ways that increase access to affordable , healthful food is a promising strategy for improving dietary behaviors among low-income , racial and ethnic minority groups at increased risk for obesity and other food-related chronic diseases . Discount , mobile F&V markets address all the major barriers to eating more F&V ( high cost , poor quality , limited access and limited time to shop and cook ) and provide a year-round solution to limited access to healthful food in low-income neighborhoods . LWVB is the first r and omized controlled trial evaluating the effectiveness of mobile markets at increasing F&V intake . If proven efficacious at increasing F&V consumption , LWVB could be disseminated widely to neighborhoods that have low access to fresh F&V.Trials registration Clinicatrials.gov registration number : NCT02669472 First Received : January 19 , 2016 Purpose . To assess the effectiveness of a large-scale , national smoking cessation media campaign , the EX campaign , across racial/ethnic and educational subgroups . Design . A longitudinal r and om-digit-dial panel study conducted prior to and 6 months following the national launch of the campaign . Setting . The sample was drawn from eight design ated media markets in the United States . Subjects . The baseline survey was conducted on 5616 current smokers , aged 18 to 49 years , and 4067 ( 73 % follow-up response rate ) were resurveyed at the 6-month follow-up . Measures . The primary independent variable is confirmed awareness of the campaign advertising , and the outcome variables are follow-up cessation-related cognitions index score and quit attempts . Analysis . Multivariable logistic and linear regression analyses were conducted within racial/ethnic and educational strata to assess the strength of association between confirmed awareness of campaign advertising and cessation-related outcomes . Results . Confirmed awareness of campaign advertising increased favorable cessation-related cognitions among Hispanics and quit attempts among non-Hispanic blacks , and increased favorable cessation-related cognitions and quit attempts among smokers with less than a high school education . Conclusions . These results suggest that the EX campaign may be effective in promoting cessation-related cognitions and behaviors among minority and disadvantaged smokers who experience a disproportionate burden of tobacco-related illness and mortality . ( Am J Health Promot 2011;25[5 Supplement]:S38–S50 . Background Indigenous Australians suffer a disproportionate burden of preventable chronic disease compared to their non-Indigenous counterparts – much of it diet-related . Increasing fruit and vegetable intakes and reducing sugar-sweetened soft-drink consumption can reduce the risk of preventable chronic disease . There is evidence from some general population studies that subsidising healthier foods can modify dietary behaviour . There is little such evidence relating specifically to socio-economically disadvantaged population s , even though dietary behaviour in such population s is arguably more likely to be susceptible to such interventions .This study aims to assess the impact and cost-effectiveness of a price discount intervention with or without an in-store nutrition education intervention on purchases of fruit , vegetables , water and diet soft-drinks among remote Indigenous communities . Methods / Design We will utilise a r and omised multiple baseline ( stepped wedge ) design involving 20 communities in remote Indigenous Australia . The study will be conducted in partnership with two store associations and twenty Indigenous store boards . Communities will be r and omised to either i ) a 20 % price discount on fruit , vegetables , water and diet soft-drinks ; or ii ) a combined price discount and in-store nutrition education strategy . These interventions will be initiated , at one of five possible time-points , spaced two-months apart . Weekly point-of-sale data will be collected from each community store before , during , and for six months after the six-month intervention period to measure impact on purchasing of discounted food and drinks . Data on physical , social and economic factors influencing weekly store sales will be collected in order to identify important covariates . Intervention fidelity and mediators of behaviour change will also be assessed . Discussion This study will provide original evidence on the effectiveness and cost-effectiveness of price discounts with or without an in-store nutrition education intervention on food and drink purchasing among a socio-economically disadvantaged population in a real-life setting .Trial registration Australian New Zeal and Clinical Trials Registry : A self-administered mood management intervention program for smoking cessation provided through the mail to Spanish-speaking Latinos result ed in a 23 % abstinence rate at 3 months compared to an 11 % abstinence rate for a smoking cessation guide alone . Participants ( N = 136 ) were r and omly assigned to receive either the cessation guide ( the Guía ) , or the Guía plus a mood management intervention ( Tom and o Control de su Vida ) presented in writing and in audiotape format . At 3 months after r and om assignment , 16 out of 71 of those assigned to the Guía-plus-mood management condition reported being abstinent ( not smoking for at least 7 days ) compared to 7 out of 65 in the Guía-only condition ( z = 1.8 ; p = .04 , one-tailed ) . Moreover , those with a history of major depressive episodes , but not currently depressed , reported an even higher abstinence rate in the Guía-plus-mood management condition , compared to the Guía-only condition ( 31 vs. 11 % , z = 1.8 , p = .04 , one-tailed ) . We conclude that the mood management mail intervention substantially increases abstinence rates , especially for those with a history of major depressive episodes During the postpartum period , ethnic minority women have higher rates of inactivity/under-activity than white women . The Nā Mikimiki ( “ the active ones ” ) Project is design ed to increase moderate-to-vigorous physical activity over 18 months among multiethnic women with infants 2–12 months old . The study was design ed to test , via a r and omized controlled trial , the effectiveness of a tailored telephone counseling of moderate-to-vigorous physical activity intervention compared to a print/website material s-only condition . Healthy , underactive women ( mean age = 32 ± 5.6 years ) with a baby ( mean age = 5.7 ± 2.8 months ) were enrolled from 2008–2009 ( N = 278 ) . Of the total sample , 84 % were ethnic minority women , predominantly Asian – American and Native Hawaiian . Mean self-reported baseline level of moderate-to-vigorous physical activity was 40 minutes/week with no significant differences by study condition , ethnicity , infant 's age , maternal body mass index , or maternal employment . Women had high scores on perceived benefits , self-efficacy , and environmental support for exercise but low scores on social support for exercise . This multiethnic sample 's demographic and psychosocial characteristics and their perceived barriers to exercise were comparable to previous physical activity studies conducted largely with white postpartum women . The Nā Mikimiki Project 's innovative tailored technology-based intervention and unique population are significant contributions to the literature on moderate-to-vigorous physical activity in postpartum women Purpose . To examine the efficacy of a stage-targeted physical activity intervention among low-income African-Americans . Methods . 207 participants were r and omly assigned to groups and administered baseline measures . Intervention participants were mailed stage-targeted physical activity information , whereas control participants received low-sodium diet brochures . Measures were readministered by phone 1 and 6 months later , with response rates of 69 % and 46 % , respectively . Results . 69 % of participants were African-American and 64 % had a monthly household income of < $ 1000 . A doubly-multivariate analysis of variance indicated that intervention participants reported more physical activity than control participants at 1 month ( F(1 , 204 ) = 4.03 , p < .05 ) . Unlike control participants , intervention participants reported significant stage progression at 1 month , according to a McNemar χ2 test . Gains attenuated by 6 months . Conclusions . The current study supports the use of this intervention among low-income African-Americans . Limitations include use of self-report measures and small sample size Background Tailored health communications to date have been based on a rather narrow set of theoretical constructs . Purpose This study was design ed to test whether tailoring a print-based fruit and vegetable ( F & V ) intervention on relatively novel constructs from self-determination theory ( SDT ) and motivational interviewing ( MI ) increases intervention impact , perceived relevance , and program satisfaction . The study also aim ed to explore possible user characteristics that may moderate intervention response . Methods African American adults were recruited from two integrated health care delivery systems , one based in the Detroit Metro area and the other in the Atlanta Metro area , and then r and omized to receive three tailored newsletters over 3 months . One set of newsletters was tailored only on demographic and social cognitive variables ( control condition ) , whereas the other ( experimental condition ) was tailored on SDT and MI principles and strategies . The primary focus of the newsletters and the primary outcome for the study was fruit and vegetable intake assessed with two brief self-report measures . Preference for autonomy support was assessed at baseline with a single item : “ In general , when it comes to my health I would rather an expert just tell me what I should do ” . Most between-group differences were examined using change scores . Results A total of 512 ( 31 % ) eligible participants , of 1,650 invited , were enrolled , of which 423 provided complete 3-month follow-up data . Considering the entire sample , there were no significant between-group differences in daily F & V intake at 3 month follow-up . Both groups showed similar increases of around one serving per day of F & V on the short form and half a serving per day on the long form . There were , however , significant interactions of intervention group with preference for autonomy-supportive communication as well as with age . Specifically , individuals in the experimental intervention who , at baseline , preferred an autonomy-supportive style of communication increased their F & V intake by 1.07 servings compared to 0.43 servings among controls . Among younger controls , there was a larger change in F & V intake , 0.59 servings , than their experimental group counterparts , 0.29 servings . Conversely , older experimental group participants showed a larger change in F & V , 1.09 servings , than older controls , 0.48 . Conclusion Our study confirms the importance of assessing individual differences as potential moderators of tailored health interventions . For those who prefer an autonomy-supportive style of communication , tailoring on values and other motivational constructs can enhance message impact and perceived relevance Background Hypertension is more prevalent and clinical ly severe among African – Americans than whites . Several health behaviors influence blood pressure ( BP ) control , but effective , accessible , culturally sensitive interventions that target multiple behaviors are lacking . Purpose We evaluated a culturally adapted , automated telephone system to help hypertensive , urban African – American adults improve their adherence to their antihypertensive medication regimen and to evidence -based guidelines for dietary behavior and physical activity . Methods We r and omized 337 hypertensive primary care patients to an 8-month automated , multi-behavior intervention or to an education-only control . Medication adherence , diet , physical activity , and BP were assessed at baseline and every 4 months for 1 year . Data were analyzed using longitudinal modeling . Results The intervention was associated with improvements in a measure of overall diet quality ( + 3.5 points , p < 0.03 ) and in energy expenditure ( + 80 kcal/day , p < 0.03 ) . A decrease in systolic BP between groups was not statistically significant ( −2.3 mmHg , p = 0.25 ) . Conclusions Given their convenience , scalability , and ability to deliver tailored messages , automated telecommunications systems can promote self-management of diet and energy balance in urban African – Americans OBJECTIVE Many targeted interventions have been developed and tested with African Americans ( AA ) ; however , AAs are a highly heterogeneous group . One characteristic that varies across AAs is Ethnic Identity ( EI ) . Little research has been conducted on how to incorporate EI into
Output:
| Neither found significant differences between the groups ( low quality evidence ) .
Evidence on behavioural changes , and knowledge and attitudes typically found some effects in favour of receiving personalised content or no significant differences between groups ( very low quality evidence ) .
The available evidence is inadequate for underst and ing whether mass media interventions targeted toward ethnic minority population s are more effective in changing health behaviours than mass media interventions intended for the population at large .
When compared to no intervention , a targeted mass media intervention may increase the number of calls to smoking quit line , but the effect on health behaviours is unclear .
These studies could not distinguish the impact of different components , for instance the effect of hearing a message regarding behavioural change , the cultural adaptation to the ethnic minority group , or increase reach to the target group through more appropriate mass media channels . |
MS213417 | ***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 Sclerostin is an osteocyte-derived inhibitor of osteoblast activity . The monoclonal antibody romosozumab binds to sclerostin and increases bone formation . METHODS In a phase 2 , multicenter , international , r and omized , placebo-controlled , parallel-group , eight-group study , we evaluated the efficacy and safety of romosozumab over a 12-month period in 419 postmenopausal women , 55 to 85 years of age , who had low bone mineral density ( a T score of -2.0 or less at the lumbar spine , total hip , or femoral neck and -3.5 or more at each of the three sites ) . Participants were r and omly assigned to receive subcutaneous romosozumab monthly ( at a dose of 70 mg , 140 mg , or 210 mg ) or every 3 months ( 140 mg or 210 mg ) , subcutaneous placebo , or an open-label active comparator -- oral alendronate ( 70 mg weekly ) or subcutaneous teriparatide ( 20 μg daily ) . The primary end point was the percentage change from baseline in bone mineral density at the lumbar spine at 12 months . Secondary end points included percentage changes in bone mineral density at other sites and in markers of bone turnover . RESULTS All dose levels of romosozumab were associated with significant increases in bone mineral density at the lumbar spine , including an increase of 11.3 % with the 210-mg monthly dose , as compared with a decrease of 0.1 % with placebo and increases of 4.1 % with alendronate and 7.1 % with teriparatide . Romosozumab was also associated with large increases in bone mineral density at the total hip and femoral neck , as well as transitory increases in bone-formation markers and sustained decreases in a bone-resorption marker . Except for mild , generally nonrecurring injection-site reactions with romosozumab , adverse events were similar among groups . CONCLUSIONS In postmenopausal women with low bone mass , romosozumab was associated with increased bone mineral density and bone formation and with decreased bone resorption . ( Funded by Amgen and UCB Pharma ; Clinical Trials.gov number , NCT00896532 . ) Summary The FREEDOM study and its Extension provide long-term information about the effects of denosumab for the treatment of postmenopausal osteoporosis . Treatment for up to 8 years was associated with persistent reduction of bone turnover , continued increases in bone mineral density , low fracture incidence , and a favorable benefit/risk profile . Introduction This study aims to report the results through year 5 of the FREEDOM Extension study , representing up to 8 years of continued denosumab treatment in postmenopausal women with osteoporosis . Methods Women who completed the 3-year FREEDOM study were eligible to enter the 7-year open-label FREEDOM Extension in which all participants are scheduled to receive denosumab , since placebo assignment was discontinued for ethical reasons . A total of 4550 women enrolled in the Extension ( 2343 long-term ; 2207 cross-over ) . In this analysis , women in the long-term and cross-over groups received denosumab for up to 8 and 5 years , respectively . Results Throughout the Extension , sustained reduction of bone turnover markers ( BTMs ) was observed in both groups . In the long-term group , mean bone mineral density ( BMD ) continued to increase significantly at each time point measured , for cumulative 8-year gains of 18.4 and 8.3 % at the lumbar spine and total hip , respectively . In the cross-over group , mean BMD increased significantly from the Extension baseline for 5-year cumulative gains of 13.1 and 6.2 % at the lumbar spine and total hip , respectively . The yearly incidence of new vertebral and nonvertebral fractures remained low in both groups . The incidence of adverse and serious adverse events did not increase over time . Through Extension year 5 , eight events of osteonecrosis of the jaw and two events of atypical femoral fracture were confirmed . Conclusions Denosumab treatment for up to 8 years was associated with persistent reductions of BTMs , continued BMD gains , low fracture incidence , and a consistent safety profile Background A restriction in functional capacity occurs in all hip fractures and a variety of factors have been shown to influence patient functional outcome . This study sought to provide new and comprehensive insights into the role of factors influencing functional recovery six months after an accidental hip fracture . Methods A prospect i ve cohort study was conducted of patients aged 65 years or more who attended the Emergency Room ( ER ) for a hip fracture due to a fall . The following were studied as independent factors : socio-demographic data ( age , sex , instruction level , living condition , received help ) , comorbidities , characteristics of the fracture , treatment performed , destination at discharge , health-related quality of life ( 12-Item Short Form Health Survey ) and hip function ( Short Western Ontario and McMaster Universities Osteoarthritis Index ) . As main outcome functional status was measured ( Barthel Index and Lawton Instrumental Activities of Daily Living Scale ) . Data were collected during the first week after fracture occurrence and after 6 months of follow-up . Patients were considered to have deteriorated if there was worsening in their functional status as measured by Barthel Index and Lawton IADL scores . Factors associated with the outcome were studied via logistic regression analysis . Results Six months after the fall , deterioration in function was notable , with mean reductions of 23.7 ( 25.2 ) and 1.6 ( 2.2 ) in the Barthel Index and Lawton IADL Scale scores respectively . Patients whose status deteriorated were older , had a higher degree of comorbidity and were less educated than those who remained stable or improved . The multivariate model assessing the simultaneous impact of various factors on the functional prognosis showed that older patients , living with a relative or receiving some kind of social support and those with limited hip function before the fall had the highest odds of having losses in function . Conclusion In our setting , the functional prognosis of patients is determined by clinical and social factors , already present before the occurrence of the fracture . This could make it necessary to perform comprehensive assessment s for patients with hip fractures in order to identify those with a poor functional prognosis to tackle their specific needs and improve their recovery Biochemical markers of bone turnover may be useful aids for managing patients with osteoporosis . A 12-month , phase 3 , multicenter trial of Japanese patients at high risk of fracture was conducted to assess the effects of teriparatide 20 μg/day on BMD , serum markers of bone turnover , and safety . Two-hundred and seven subjects ( 93 % female ; median age 70 years ) were r and omized in double-blind fashion 2:1 to teriparatide versus placebo . Bone turnover markers including procollagen type I N-terminal propeptide ( PINP ) , bone-specific alkaline phosphatase ( bone ALP ) and type I collagen cross-linked C-telopeptide ( CTX ) were collected at baseline , 1 , 3 , 6 , and 12 months . Lumbar spine , femoral neck , and total hip BMD were measured at baseline , 3 , 6 , and 12 months . Increases in PINP at 1 month correlated best with increases in lumbar spine BMD at 12 months ( r=0.76 ; P<0.01 ) . The proportions of patients with an increase from baseline in PINP > 10 μg/L at 1 , 3 , and 6 months were 3 % , 0 % , and 2 % in the placebo , and 93 % , 87 % , and 83 % in the teriparatide group . The proportions of patients with an increase in PINP > 10 μg/L at either 1 or 3 months were 3 % in the placebo and 95 % in the teriparatide group ( P<0.001 ) . The proportions of patients with a significant increase in lumbar spine BMD ( increase from baseline ≥3 % ) at 12 months were 20 % in the placebo and 94 % in the teriparatide group . The proportions of patients with an increase in PINP > 10 μg/L at 1 or 3 months and an increase in lumbar spine BMD ≥3 % at 12 months was 0 % of placebo group patients and 92 % of teriparatide group patients ( P<0.001 ) . These data confirm a strong relationship between early change in PINP and later change in lumbar spine BMD during teriparatide therapy . Also , these results suggest that monitoring with PINP and lumbar spine BMD successfully identifies positive responses in most patients taking teriparatide and negative responses in most patients not taking teriparatide . PINP monitoring may be a useful aid in the management of patients with osteoporosis during teriparatide treatment BACKGROUND Romosozumab is a monoclonal antibody that inhibits sclerostin and rapidly increases bone mineral density ( BMD ) through a dual effect on bone by increasing bone formation and decreasing bone resorption , as shown in a global phase 2 study in postmenopausal women with low bone mass . Here , we report the key results of a phase 2 , double-blind , placebo-controlled , dose-ranging study to assess the efficacy and safety of romosozumab in postmenopausal Japanese women with osteoporosis . METHODS Participants were postmenopausal Japanese women with osteoporosis aged 55 - 85years with a lumbar spine , total hip , or femoral neck dual-energy X-ray absorptiometry T-score≤-2.5 . Women were r and omized to receive placebo or romosozumab ( 70 , 140 , or 210 mg ) subcutaneously once monthly ( QM ) for 12months . The primary efficacy endpoint was the percentage change from baseline in lumbar spine BMD at month 12 . Secondary efficacy endpoints included the percentage change from baseline in lumbar spine BMD at month 6 , total hip and femoral neck BMD at months 6 and 12 , and serum bone turnover markers procollagen type 1N-terminal propeptide ( P1NP ) and C-terminal telopeptide of type 1 collagen ( CTX ) at multiple visits . RESULTS This study enrolled 252 women who had a mean age of 67.7years and mean T-scores of -2.7 , -1.9 , and -2.3 at the lumbar spine , total hip , and femoral neck , respectively . All romosozumab doses significantly increased BMD at month 12 compared with placebo ( p<0.01 ) , with the largest mean gains from baseline observed with romosozumab 210 mg QM ( lumbar spine=16.9 % , total hip=4.7 % , and femoral neck=3.8 % ) . All doses of romosozumab significantly increased the levels of bone-formation marker P1NP and reduced the levels of bone-resorption marker CTX by week 1 ( p<0.001 vs placebo ) . In the 210 mg QM group , P1NP levels peaked at month 1 and fell below placebo levels by month 12 ; CTX levels were lowest at week 1 and remained below placebo through month 12 . The patient incidences of adverse events and serious adverse events were generally comparable between treatment groups . CONCLUSIONS In postmenopausal Japanese women with osteoporosis , romosozumab treatment result ed in large and significant gains in BMD from baseline and compared with placebo . Romosozumab 210 mg QM showed the largest gains in BMD and was generally well tolerated . The efficacy and safety of romosozumab 210 mg QM in this phase 2 study of postmenopausal women with osteoporosis were similar to those in an international phase 2 study PURPOSE To compare the power of FRAX ® without bone mineral density ( BMD ) and simpler screening tools ( OST , ORAI , OSIRIS , SCORE and age alone ) in predicting fractures . METHODS This study was a prospect i ve , population -based study performed in Denmark comprising 3614 women aged 40 - 90 years , who returned a question naire concerning items on risk factors for osteoporosis . Fracture risk was calculated using the different screening tools ( FRAX ® , OST , ORAI , OSIRIS and SCORE ) for each woman . The women were followed using the Danish National Register registering new major osteoporotic fractures during 3 years , counting only the first fracture per person . Area under the receiver operating characteristic curve ( ROC ) and statistics and Harrell 's index were calculated . Agreement between the tools was calculated by kappa statistics . RESULTS A total of 4 % of the women experienced a new major osteoporotic fracture during the follow-up period . There were no differences in the area under the curve ( AUC ) values between FRAX ® and the simpler tools ; AUC values between 0.703 and 0.722 ( p = 0.86 ) . Also , Harrell 's C values were very similar between the tools . Agreement between the tools was modest . CONCLUSION During 3 years follow-up FRAX ® did not perform better in the fracture risk prediction compared with simpler tools such as OST , ORAI , OSIRIS , SCORE or age alone in a screening scenario where BMD was not measured . These findings suggest that simpler models based on fewer risk
Output:
| However , this difference was not statistically significant .
Treatment with anti-sclerostin antibodies can be a proper therapeutic option in patients with osteoporosis and low bone mineral density .
Based on the results of this meta- analysis , it seems that Romosozumab , with its dual function , has a positive role in the treatment of osteoporosis and low bone mineral density |
MS213418 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: We sought to clarify whether a single-bolus intravenous administration of sodium bicarbonate in addition to hydration with sodium chloride prevents contrast-induced nephropathy ( CIN ) . One hundred forty-four patients with mild renal insufficiency ( serum creatinine > 1.1 to < 2.0 mg/dl ) undergoing an elective coronary procedure were r and omly assigned to the following 2 groups : st and ard hydration with sodium chloride plus single-bolus intravenous administration of sodium bicarbonate ( 20 mEq ) immediately before contrast exposure ( group A , n = 72 ) and st and ard hydration alone ( group B , n = 72 ) . The primary end point was development of CIN , defined as an increase > 25 % or > 0.5 mg/dl in serum creatinine within 3 days after the procedure . Incidence of the primary end point was lower in group A than in group B ( 1.4 % vs 12.5 % , p = 0.017 ) . Incidence of adverse clinical events ( acute pulmonary edema , acute renal failure requiring dialysis , and death within 7 days of procedure ) did not differ between the 2 groups ( 0 % vs 1.4 % ) . In conclusion , single-bolus intravenous administration of sodium bicarbonate in addition to st and ard hydration can more effectively prevent CIN than st and ard hydration alone in patients with mild renal insufficiency undergoing an elective coronary procedure CONTEXT Contrast-induced nephropathy remains a common complication of radiographic procedures . Pretreatment with sodium bicarbonate is more protective than sodium chloride in animal models of acute ischemic renal failure . Acute renal failure from both ischemia and contrast are postulated to occur from free-radical injury . However , no studies in humans or animals have evaluated the efficacy of sodium bicarbonate for prophylaxis against contrast-induced nephropathy . OBJECTIVE To examine the efficacy of sodium bicarbonate compared with sodium chloride for preventive hydration before and after radiographic contrast . DESIGN , SETTING , AND PATIENTS A prospect i ve , single-center , r and omized trial conducted from September 16 , 2002 , to June 17 , 2003 , of 119 patients with stable serum creatinine levels of at least 1.1 mg/dL ( > or = 97.2 micromol/L ) who were r and omized to receive a 154-mEq/L infusion of either sodium chloride ( n = 59 ) or sodium bicarbonate ( n = 60 ) before and after iopamidol administration ( 370 mg iodine/mL ) . Serum creatinine levels were measured at baseline and 1 and 2 days after contrast . INTERVENTIONS Patients received 154 mEq/L of either sodium chloride or sodium bicarbonate , as a bolus of 3 mL/kg per hour for 1 hour before iopamidol contrast , followed by an infusion of 1 mL/kg per hour for 6 hours after the procedure . MAIN OUTCOME MEASURE Contrast-induced nephropathy , defined as an increase of 25 % or more in serum creatinine within 2 days of contrast . RESULTS There were no significant group differences in age , sex , incidence of diabetes mellitus , ethnicity , or contrast volume . Baseline serum creatinine was slightly higher but not statistically different in patients receiving sodium bicarbonate treatment ( mean [ SD ] , 1.71 [ 0.42 ] mg/dL [ 151.2 [ 37.1 ] micromol/L ] for sodium chloride and 1.89 [ 0.69 ] mg/dL [ 167.1 [ 61.0 ] micromol/L ] for sodium bicarbonate ; P = .09 ) . The primary end point of contrast-induced nephropathy occurred in 8 patients ( 13.6 % ) infused with sodium chloride but in only 1 ( 1.7 % ) of those receiving sodium bicarbonate ( mean difference , 11.9 % ; 95 % confidence interval [ CI ] , 2.6%-21.2 % ; P = .02 ) . A follow-up registry of 191 consecutive patients receiving prophylactic sodium bicarbonate and meeting the same inclusion criteria as the study result ed in 3 cases of contrast-induced nephropathy ( 1.6 % ; 95 % CI , 0%-3.4 % ) . CONCLUSION Hydration with sodium bicarbonate before contrast exposure is more effective than hydration with sodium chloride for prophylaxis of contrast-induced renal failure BACKGROUND Several protective therapies have been developed to prevent contrast-induced nephropathy ( CIN ) . We aim ed to investigate the efficacy of sodium bicarbonate by comparing 2 other regimens , including combination of N-acetylcysteine ( NAC ) plus sodium chloride and sodium chloride alone , to prevent CIN in patients undergoing cardiovascular procedures . METHODS We prospect ively enrolled 264 patients who were scheduled for cardiovascular procedures and had a baseline creatinine level > 1.2 mg/dL. The patients were assigned 1 of 3 prophylactic regimens : infusion of sodium bicarbonate , sodium chloride , sodium chloride plus oral NAC ( 600 mg bid ) . Contrast-induced nephropathy was defined as an increase in serum creatinine level > 25 % or 0.5 mg/dL after 48 hours . RESULTS There were no significant differences among groups regarding baseline demographic properties and nephropathy risk factors . The change in creatinine clearance was significantly better in the sodium bicarbonate group than other 2 groups ( P = .007 ) . The incidence of CIN was significantly lower in the sodium bicarbonate group ( 4.5 % ) compared with sodium chloride alone ( 13.6 % , P = .036 ) and tended to be lower than in the combination group ( 12.5 % , P = .059 ) . After adjusting the Mehran nephropathy risk score , the risk of CIN significantly reduced with sodium bicarbonate compared with sodium chloride alone ( adjusted risk ratio 0.29 , P = .043 ) . CONCLUSIONS Hydration with sodium bicarbonate provides better protection against CIN than the sodium chloride infusion does alone . Combination therapy of NAC plus sodium chloride did not offer additional benefit over hydration with sodium chloride alone BACKGROUND Contrast-induced nephropathy ( CIN ) continues to be a common cause of acute renal failure in high-risk patients undergoing radiocontrast studies . However , there is still a lack of consensus regarding the most effective measures to prevent CIN . METHODS ONE HUNDRED EIGHTEEN PATIENTS WITH DIABETES MELLITUS AND /OR RENAL INSUFFICIENCY , SCHEDULED FOR CORONARY ANGIOGRAPHY OR INTERVENTION , WERE R AND OMLY ASSIGNED TO ONE OF FOUR TREATMENT GROUPS : intravenous ( IV ) 0.9 % NaCl alone , IV 0.9 % NaCl plus N-acetylcysteine ( NAC ) , IV 0.9 % sodium bicarbonate ( NaHCO(3 ) ) alone or IV 0.9 % NaHCO(3 ) plus NAC . All patients received IV hydration as a preprocedure bolus and as maintenance . Iso-osmolar contrast was used in all patients . CIN was defined as an increase of greater than 25 % in the serum creatinine concentration from baseline to 72 h. RESULTS The overall incidence of CIN was 6 % . There was no statistically significant difference in the incidence of CIN among the groups . There was a CIN incidence of 7 % in the NaCl only group , 5 % in the NaCl/NAC group , 11 % in the NaHCO(3 ) only group and 4 % in the NaHCO(3)/NAC group ( P=0.86 ) . The maximum increase in serum creatinine was 14.14±12.38 μmol/L in the NaHCO(3 ) group , 10.60±29.14 μmol/L in the NaCl only group , 9.72±13.26 μmol/L in the NaCl/NAC group and 0.177±15.91 μmol/L for the NaHCO(3)/NAC group ( P=0.0792 ) . CONCLUSION CIN in high-risk patients may be effectively minimized solely through the use of an aggressive hydration protocol and an iso-osmolar contrast agent . The addition of NaHCO(3 ) and /or NAC did not have an effect on the incidence of CIN Despite myriad improvements in the care of hospitalized patients , a decline in renal function remains a common event . Renal function in 4,622 consecutive patients admitted to the medical and surgical services of an urban tertiary care hospital was followed up prospect ively from the time of admission . Some degree of renal insufficiency developed in 7.2 % of patients . Decreased renal perfusion , medications , surgery , and radiographic contrast media were the most common causes of hospital-acquired renal insufficiency ( HARI ) . The overall mortality rate was 19.4 % and was similar among patients for all causes of renal insufficiency , except sepsis . For patients with a greater than 3.0-mg/dL increase in serum creatinine level , the mortality rate was 37.8 % . As shown by previous investigators , age and preexisting renal insufficiency were risk factors for HARI . Women and blacks had less hospital-acquired renal failure . The increasing acuity of hospital admissions has been accompanied by a greater incidence of acute renal insufficiency in patients admitted to hospitals . There is a trend toward better survival in patients with a severe deterioration in renal function AIMS The most effective regimen for the prevention of contrast-induced nephropathy ( CIN ) remains uncertain . Our purpose was to compare two regimens of sodium bicarbonate with 24 h sodium chloride 0.9 % infusion in the prevention of CIN . METHODS AND RESULTS We performed a prospect i ve , r and omized trial between March 2005 and December 2009 , including 258 consecutive patients with renal insufficiency undergoing intravascular contrast procedures . Patients were r and omized to receive intravenous volume supplementation with either ( A ) sodium chloride 0.9 % 1 mL/kg/h for at least 12h prior and after the procedure or ( B ) sodium bicarbonate ( 166 mEq/L ) 3 mL/kg for 1 h before and 1 mL/kg/h for 6 h after the procedure or ( C ) sodium bicarbonate ( 166 mEq/L ) 3 mL/kg over 20 min before the procedure plus sodium bicarbonate orally ( 500 mg per 10 kg ) . The primary endpoint was the change in estimated glomerular filtration rate ( eGFR ) within 48 h after contrast . Secondary endpoints included the development of CIN . The maximum change in eGFR was significantly greater in Group B compared with Group A { mean difference -3.9 [ 95 % confidence interval ( CI ) , -6.8 to -1 ] mL/min/1.73 m2 , P = 0.009 } and similar between groups C and B [ mean difference 1.3 ( 95 % CI , -1.7 - 4.3 ) mL/min/1.73 m(2 ) , P = 0.39 ] . The incidence of CIN was significantly lower in Group A ( 1 % ) vs. Group B ( 9 % , P = 0.02 ) and similar between Groups B and C ( 10 % , P = 0.9 ) . CONCLUSION Volume supplementation with 24 h sodium chloride 0.9 % is superior to sodium bicarbonate for the prevention of CIN . A short-term regimen with sodium bicarbonate is non-inferior to a 7 h regimen . Clinical Trials.gov Identifier : NCT00130598 OBJECTIVES This study was design ed to determine the effectiveness of a protocol for rapid intravenous hydration to prevent contrast-induced nephropathy ( CIN ) in patients undergoing emergency percutaneous coronary intervention ( PCI ) . BACKGROUND Contrast-induced nephropathy frequently complicates PCI , result ing in prolonged hospitalization and increased in-hospital and long-term morbidity and mortality . Little is known regarding prevention of CIN in patients undergoing urgent PCI . METHODS We conducted a prospect i ve , controlled , r and omized , single-center trial in 111 consecutive patients with acute coronary syndrome undergoing emergency PCI . As part of the hydration therapy , 56 patients ( group A ) received an infusion of sodium bicarbonate plus N-acetylcysteine ( N-AC ) started just before contrast injection and continued for 12 h after PCI . The remaining 55 patients ( group B ) received the st and ard hydration protocol consisting of intravenous isotonic saline for 12 h after PCI . In both groups , 2 doses of oral N-AC were administered the next day .
Output:
| Overall , hydration with sodium bicarbonate could significantly reduce CIN and the length of hospital stay compared to sodium chloride .
In addition NAC added as a supplement to sodium bicarbonate could increase prophylactic effects against nephropathy |
MS213419 | ***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 : Interventions to improve adherence to regular mammography screening have had conflicting results . Many studies have depended on women ’s self-report rather than clinical evidence of a mammography encounter . Methods : We tested the impact of two interventions on a population -based sample of NH women who were not receiving routine mammography to determine if adherence to screening could be improved . The interventions included a mailing of women ’s health information and a telephone counseling intervention based on the Transtheoretical Model . Participant eligibility and outcome measures were based on clinical events obtained from a population -based mammography registry . Results : Two hundred and fifty eight women completed all aspects of the intervention study . The women were r and omly assigned to one of two study groups : 51 % received the mail intervention and 49 % received the telephone intervention . Among women who received the telephone counseling intervention , 67 % percent reported being in either an action or maintenance stage at Call 1 , which increased to 84 % at Call 2 ( p<0.001 ) . Seventy-six percent of women identified barriers to screening mammography at Call 1 , which decreased to 44 % at Call 2 ( p<0.01 ) . The most frequently identified barrier was confusion over the guidelines for screening mammography . At the first assessment time interval , greater than 60 % of women were up-to- date for screening mammography in the group that received telephone counseling versus 48 % in the group that received health information by mail ( p = 0.04 ) . However , women ’s status as up-to- date fell for both groups between the first and second assessment time intervals . Conclusions : Tailored telephone counseling based on the Transtheoretical Model can improve adherence to screening mammography , though the duration of this effect is in question The effect on women ’s breast cancer screening utilization of a barrier-specific telephone counseling ( BSTC ) intervention , with and without a concurrent continuing medical education ( CME ) activity for their physicians , was evaluated . All participants ( 50 - 80 years of age ) were not regular mammography users at baseline . A 4-arm quasi-experimental design was employed . Women were r and omized to the BSTC or no BSTC group and assigned ( with their physicians ) to the CME or no CME group based on place of residence . Pre- and postintervention data were obtained for 1,601 women using telephone interviews conducted during 1995 and 1998 , respectively . Among women who had ever used mammography at baseline , those who received BSTC were more likely than the control group to become regular mammography users at follow-up ( OR = 1.4 , p = .033 ) . Greater reductions in perceived barriers to mammography , from baseline to follow-up , were significantly associated with receiving BSTC compared with the control group ( p = .001 ) , among women with previous mammography experience . Findings suggest that CME may have potential for initiating mammography use among women who never had a previous mammogram . However , because of the small sample available for analyses of the CME intervention and differential attrition among women who never had a previous mammogram , further study is needed to confirm this hypothesis BACKGROUND Few health promotion trials have evaluated strategies to increase regular mammography screening . We conducted a r and omized controlled trial of two theory-based interventions in a population -based , nationally representative sample of women veterans . METHODS Study c and i date s 52 years and older were r and omly sample d from the National Registry of Women Veterans and r and omly assigned to three groups . Groups 1 and 2 received interventions that varied in the extent of personalization ( tailored and targeted vs targeted-only , respectively ) ; group 3 was a survey-only control group . Postintervention follow-up surveys were mailed to all women after 1 and 2 years . Outcome measures were self-reported mammography coverage ( completion of one postintervention mammogram ) and compliance ( completion of two postintervention mammograms ) . In decreasingly conservative analyses ( intention-to-treat [ ITT ] , modified intention-to-treat [ MITT ] , and per- protocol [ PP ] ) , we examined crude coverage and compliance estimates and adjusted for covariates and variable follow-up time across study groups using Cox proportional hazards regression . For the PP analyses , we also used logistic regression . RESULTS None of the among-group differences in the crude incidence estimates for mammography coverage was statistically significant in ITT , MITT , or PP analyses . Crude estimates of compliance differed at statistically significant levels in the PP analyses and at levels approaching statistical significance in the ITT and MITT analyses . Absolute differences favoring the intervention over the control groups were 1%-3 % for ITT analysis , 1%-5 % for MITT analysis , and 2%-6 % for the PP analysis . Results from Cox modeling showed no statistically significant effect of the interventions on coverage or compliance in the ITT , MITT , or PP analyses , although hazard rate ratios ( HRRs ) for coverage were consistently slightly higher in the intervention groups than the control group ( range for HRRs = 1.05 - 1.09 ) . A PP analysis using logistic regression produced odds ratios ( ORs ) that were consistently higher than the corresponding hazard rate ratios for both coverage and compliance ( range for ORs = 1.15 - 1.29 ) . CONCLUSIONS In none of our primary analyses did the tailored and targeted intervention result in higher mammography rates than the targeted-only intervention , and there was limited support for either intervention being more effective than the baseline survey alone . We found that adjustment for variable follow-up time produced more conservative ( less favorable ) intervention effect estimates Community clinics provide inadequate breast cancer screening services to low-income , racially- and ethnically-diverse communities . This study develops and evaluates the effectiveness of multifaceted organizational system interventions —operational assessment s , tracking systems , reminder calls , tailored education , physician prompts and a tailored counseling call — on mammography rescreening rates within three community clinics . We used the Chronic Care Model and Put Prevention Into Practice framework to re design breast screening delivery services within the California Cancer Detection Programs : Every Woman Counts(CDP : EWC ) , community clinic setting s. We used a quasi-experimental design with a r and om selection of 400 patients at pre-intervention . To establish a post-intervention clinic ’s rescreening rate a new comparable cross-sectional r and om sample of 347 women was drawn . Measures A chart abstract ion instrument was used to establish clinics ’ rescreening rates . Subjects Participants at pre and post-intervention were low-income women 50 years of age and older who had received normal mammography results and had not been diagnosed with breast cancer in the last five years . General linear mixed model analysis revealed significant improvements for the organizational system re design condition [ pre-intervention rescreening rate : 32.1 percent v. post-intervention rescreening rate 50.2 percent , ( p < .001 ) ] . For the organizational system re design plus tailored counseling call condition , there was maintenance in the rescreening rate following the intervention [ pre-intervention : 44.4 percent v. post-intervention : 45.1 percent , ( p > 0.05 ) ] . Multilevel interventions directed at re design ing community clinics primary care breast cancer screening services , can improve mammography rescreening rates OBJECTIVES This study assessed the effectiveness of telephone counseling in a church-based mammography promotion intervention trial . METHODS Thirty churches were r and omized to telephone counseling and control conditions ; telephone interview data were used in assessing intervention effects on mammography adherence . Separate analyses were conducted for baseline-adherent participants ( maintaining adherence ) and baseline-nonadherent participants ( conversion to adherence ) . RESULTS Year 1 follow-up data indicated that the telephone counseling intervention maintained mammography adherence among baseline-adherent participants and reduced the nonadherence rate from 23 % to 16 % . CONCLUSIONS Partnerships between the public health and faith communities are potentially effective conduits to promote maintenance of widely endorsed health behaviors such as regular cancer screening Mammography screening continues to be under-utilized , especially among women from lower socioeconomic groups . In order to determine whether having direct access to health care services has an effect on mammography use among low income women , we conducted a r and omized trial of two alternative letter reminders among 1,717 women who were enrolled at two locations of a multi-site inner city health department in Detroit . All participants were 39 1/2 years of age and older and were due for a screening mammogram at r and omization . A physician-directed reminder form was placed in each of the participant ’s medical records at the beginning of the study . In addition participants were r and omized to receive either a letter directing them to visit their primary care physician , a letter directing them to contact the clinic directly to schedule a mammogram , or no letter . Study participants were predominantly African – American , two-thirds of whom were over age 50 , and who had minimal health insurance coverage . During the intervention year , mammograms were completed by 179 out of 967 study women at site one ( 18.5 % ) , and 90 out of 750 study women at site two ( 12 % ) . A multivariate model controlling for the simultaneous effect of age , insurance type , visit history and past mammography use , showed no significant independent effect of either type of letter reminder on mammography completion during the study year . In conclusion , letters targeted at women due for screening mammograms did not have a beneficial effect on mammography utilization above and beyond that of a physician medical record reminder Participation in breast cancer screening programmes often declines in the course of the programme . The purpose of the present study was to examine whether health education could diminish the amount of drop-outs between two screening rounds . The health education was tailored to women who previously underwent mammography . Based on the Elaboration Likelihood Model two versions of the tailored leaflet were made : a simple version and a version with additional peripheral cues . In an experimental study among 2961 women the effects of the tailored leaflets on reparticipation were tested against a st and ard leaflet . Re-participation rates were high ( > 90 % ) and did not differ between the 3 groups . No significant differences regarding beliefs about re-participating were found between the 3 groups . Results indicate that the tailored information leaflets did not enhance re-participation . Therefore , the required additional efforts and costs do not seem to be justified . The results of the study provide indications that less painful mammograms and friendly staff might improve re-participation BACKGROUND Despite widespread promotion of mammography screening , a distinct minority of women have remained underusers of this effective preventive measure . We sought to measure the effects of barrier-specific telephone counseling ( BSTC ) and a physician-based educational intervention ( MD-ED ) on mammography utilization among underusers of mammography screening . DESIGN This was a r and omized controlled trial . Women meeting criteria for mammography underuse at baseline ( grouped by practice affiliation ) were r and omized to a reminder control condition ( RC group received annual mailed reminders ) , BSTC or MD-ED interventions and followed for 3 years . Underuse was defined by failure to get two annual or biannual mammograms over a 2- to 4-year period prior to a baseline survey . PARTICIPANTS AND SETTING The study included 1655 female underusers of mammography aged 50 - 80 years who were members of two health maintenance organizations ( HMO ) in central Massachusetts . INTERVENTIONS BSTC consisted of periodic brief , scripted calls from trained counselors to women who had not had a mammogram in the preceding 15 months . Women could receive up to three annual calls during the study . MD-ED consisted of physician and office staff trainings aim ed at improving counseling skills and office reminder systems . MAIN OUTCOME MEASURE Self-report of mammography use during the study period was the main outcome measure . Regular use was defined as > or = 1 mammogram every 24 months . RESULTS Forty-four percent in each intervention group became regular users compared to 42 % in the RC group . Among subjects who had prior but not recent mammograms at baseline , BSTC was effective ( OR=1.48 ; 95 % CI=1.04 ; 2 . 10 ) , and MD-ED marginally effective ( OR=1.28 ; 95 % CI=0.88 , 1.85 ) . Most recent users at baseline and few never users became regular users ( 61 % and 17 % , respectively ) regardless of intervention status . CONCLUSIONS Among mammography underusers BSTC modestly increases utilization for former users at a reasonable cost ( $ 726 per additional regular user ) OBJECTIVE To assess added value of a booster dose of a tailored mammography intervention . METHODS Participants , non-adherent at baseline , were r and omly assigned to usual care or one of three tailored interventions . Intervention group members ( n=657 ) were further r and omly assigned to receive/not receive a booster intervention dose . Electronic record mammography data were collected following initial intervention and at 6 and 15 months post-booster . RESULTS Booster had no effect among women not screened after first intervention dose ( n=337 ) . Among women screened after initial dose ( n=320 ) , booster predicted re-screening at 6 but not 15 months . A boosterxrace interaction showed a booster effect at 6 months for African Americans ( OR=4.66 , p=.0005 ) but not Caucasians ( OR=0.74 , p=.44 ) . CONCLUSIONS
Output:
| We also can not conclude that reminder-only intervention strategies are more effective than alternate strategies . |
MS213420 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: INTRODUCTION Chronic kidney disease ( CKD ) is an independent cardiovascular risk factor . The knowledge of prevalence in general population may help to early detection of CKD and prevent or delay its progression . METHODS Sociodemographic , baseline characteristics , and CKD prevalence ( measured by central ized serum creatinine and MDRD equation ) were evaluated in a r and omly selected sample of general population aged 20 years or older , collected in all Spanish regions and stratified by habitat , age and sex according to 2001 census ( n=2746 ) . Univariate and multivariate logistic regression analyses were used to evaluate associations with CKD risk factors . RESULTS Mean age was 49.5 years . The overall prevalence of Kidney Disease Outcomes Quality Initiative grade s 3 - 5 CKD was 6.8 % , with a 95 % confidence interval ( CI ) of 5.4 to 8.2 ( 3.3 % for age 40 - 64 years and 21.4 % for age > 64 years ) . The prevalence estimates of CKD stages were : 0.99 % for stage 1 ( glomerular filtration rate [ GFR ] > or=90 ml/min per 1.73 m2 with proteinuria ) ; 1.3 % for stage 2 ( GFR 60 - 89 ) ; 5.4 % for stage 3a ( GFR 45 - 59 ) ; 1.1 % for stage 3b ( GFR 30 - 44 ) ; 0.27 % for stage 4 ( GFR 15 - 29 ) ; and 0.03 % for stage 5 ( GFR < 15 ) . An important prevalence of classical cardiovascular risk factors was observed : dyslipemia ( 29.3 % ) , obesity ( 26.1 % ) , hypertension ( 24.1 % ) , diabetes ( 9.2 % ) and current smoking ( 25.5 % ) . The independent predictor factors for CKD were age , obesity and previously diagnosed hypertension . CONCLUSION The prevalence of CKD at any stage in general population from Spain is relatively high , especially in the elderly , and similar to countries of the same geographical area . Independently of age , two modifiable risks factors , hypertension and obesity , are associated with an increased prevalence of CKD Background . The prognostic value of reduced glomerular filtration rate ( GFR ) was examined in a community-based cohort of British women . Methods . Serum creatinine measurements were available for 90 % ( n = 3851 ) of a representative r and om sample of 4286 women aged 60 - 79 years . GFR was estimated using the Modification of Diet in Renal Disease equation . Hazard ratios ( HR ) were calculated using Cox regression with outcomes of all-cause and cardiovascular disease ( CVD ) mortality . Results . Eight hundred and thirty-two women ( 21.6 % ) had a GFR < 60 ml/min/1.73 m(2 ) . Over a median follow-up of 5.6 years , there were 318 deaths ( 100 CVD deaths ) . Women with GFR < 60 ml/min/1.73 m(2 ) compared to all others showed only a borderline increased risk of all-cause mortality [ HR 1.35 ( 95 % confidence intervals : 0.99 , 1.85 ) ] and CVD mortality [ 1.34 ( 0.97 , 1.85 ) ] . Adjustment for conventional CVD risk factors had little impact . The association with CVD mortality was attenuated in women with pre-existing CVD [ adjusted HR : 0.51 ( 0.24 , 1.04 ) ] . Only the subset of women without CVD at baseline were at risk for later CVD death [ adjusted HR : 1.80 ( 1.13 , 2.88 ) ] . Conclusions . A substantial proportion of older British women have GFR < 60 ml/min/1.73 m(2 ) without strong evidence for statistical association with all-cause mortality . The effect on CVD mortality is partly explained by existing CVD and its risk factors . GFR measurement appears only to play a useful role in the subset of older women without pre-existing CVD who are at higher risk of premature CVD death BACKGROUND In older adults , current equations to estimate glomerular filtration rate ( GFR ) are not vali date d and may misclassify elderly persons in terms of their stage of chronic kidney disease . OBJECTIVE To derive the Berlin Initiative Study ( BIS ) equation , a novel estimator of GFR in elderly participants . DESIGN Cross-sectional . Data were split for analysis into 2 sets for equation development and internal validation . SETTING R and om community-based population of a large insurance company . PARTICIPANTS 610 participants aged 70 years or older ( mean age , 78.5 years ) . INTERVENTION Iohexol plasma clearance measurement as gold st and ard . MEASUREMENTS GFR , measured as the plasma clearance of the endogenous marker iohexol , to compare performance of existing equations of estimated GFR with measured GFR of the gold st and ard ; estimation of measured GFR from st and ardized creatinine and cystatin C levels , sex , and age in the learning sample ; and comparison of the BIS equations ( BIS1 : creatinine-based ; BIS2 : creatinine- and cystatin C-based ) with other estimating equations and determination of bias , precision , and accuracy in the validation sample . RESULTS The new BIS2 equation yielded the smallest bias followed by the creatinine-based BIS1 and Cockcroft-Gault equations . All other equations considerably overestimated GFR . The BIS equations confirmed a high prevalence of persons older than 70 years with a GFR less than 60 mL/min per 1.73 m2 ( BIS1 , 50.4 % ; BIS2 , 47.4 % ; measured GFR , 47.9 % ) . The total misclassification rate for this criterion was smallest for the BIS2 equation ( 11.6 % ) , followed by the cystatin C equation 2 ( 15.1 % ) proposed by the Chronic Kidney Disease Epidemiology Collaboration . Among the creatinine-based equations , BIS1 had the smallest misclassification rate ( 17.2 % ) , followed by the Chronic Kidney Disease Epidemiology Collaboration equation ( 20.4 % ) . LIMITATION There was no validation by an external data set . CONCLUSION The BIS2 equation should be used to estimate GFR in persons aged 70 years or older with normal or mild to moderately reduced kidney function . If cystatin C is not available , the BIS1 equation is an acceptable alternative . PRIMARY FUNDING SOURCE Kuratorium für Dialyse und Nierentransplatation ( KfH ) Foundation of Preventive Medicine Background The prevalence of chronic kidney disease ( CKD ) using available estimating equations with the Republic of Irel and is unknown . Methods A r and omly selected population based cross-sectional study of 1,098 adults aged 45 years and older was conducted using data from the 2007 Survey of Lifestyle , Attitudes and Nutrition ( SLÁN ) . Estimated Glomerular Filtration Rate ( eGFR ) was calculated from a single IDMS aligned serum creatinine using the CKD-EPI and the MDRD equations , and albumin to creatinine ratio was based on a single r and om urine sample . Results The sample clinical characteristics and demography was similar to middle and older age adults in the general Irish population , though with an underrepresentation of subjects > 75 years and of males . All results are based on subjects with available blood and urine sample s. Applying weighting to obtain survey based population estimates , using Irish population census data , the estimated weighted prevalence of CKD-EPI eGFR<60 mL/min/1.73m2 was 11.6 % , ( 95 % confidence interval ; 9.0 , 14.2 % ) , 12.0 % ( 9.0 , 14.2 % ) of men and 11.2 % ( 7.3 , 15.2 % ) of women . Unweighted prevalence estimates were similar at 11.8 % ( 9.9 , 13.8 % ) . Albuminuria increased with lower CKD-EPI eGFR category . 10.1 % of all subjects had albuminuria and an eGFR≥60 mL/min/1.73 m2 giving an overall weighted estimated prevalence of National Kidney Foundation ( NKF ) defined CKD 21.3 % ( 18.0 , 24.6 % ) , with the unadjusted estimate of 21.9 % ( 19.5 , 24.4 % ) . MDRD related estimates for eGFR < 60 mL/min/1.73 m2 , and NFK defined CKD were higher than CKD-EPI and differences were greater in younger and female subjects . Conclusions CKD is highly prevalent in middle and older aged adults within the Republic of Irel and . In this population , there is poor agreement between CKD-EPI and MDRD equations especially at higher GFRs . CKD is associated with lower educational status and poor self rated health BACKGROUND We investigate whether the urinary proteome refines the diagnosis of renal dysfunction , which affects over 10 % of the adult population . METHODS We measured serum creatinine , estimated glomerular filtration rate ( eGFR ) and 24-h albuminuria in 797 people r and omly recruited from a population . We applied capillary electrophoresis coupled with mass spectrometry to measure multi-dimensional urinary proteomic classifiers developed for renal dysfunction ( CKD273 ) or left ventricular dysfunction ( HF1 and HF2 ) . Renal function was followed up in 621 participants and the incidence of cardiovascular events in the whole study population . RESULTS In multivariable-adjusted cross-sectional analyses , higher biomarker levels analysed separately or combined by principal component analysis into a single factor ( SF ) , correlated ( P ≤ 0.010 ) with worse renal function . Over 4.8 years , higher HF1 and SF predicted ( P ≤ 0.014 ) lowering of eGFR ; higher HF2 predicted ( P ≤ 0.049 ) increase in serum creatinine and decrease eGFR . HF1 , HF2 and SF predicted progression from CKD Stages 2 or ≤2 to Stage ≥3 , with risk estimates for a 1-SD increment in the urinary biomarkers ranging from 38 to 71 % ( P ≤ 0.039 ) . HF1 , HF2 and SF yielded a net reclassification improvement of 31 - 51 % ( P ≤ 0.029 ) . Over 6.1 years , 47 cardiovascular events occurred . HF2 and SF , independent of baseline eGFR , 24-h albuminuria and other covariables were significant predictors of cardiovascular complications with risk estimates for 1-SD increases ranging from 32 to 41 % ( P ≤ 0.047 ) . CONCLUSIONS The urinary proteome refines the diagnosis of existing or progressing renal dysfunction and predicts cardiovascular complications Background Increasing evidence suggests a mechanistic link between the glycemic environment and renal and cardiovascular events , even below the threshold for diabetes . We aim ed to assess the association between HbA1c and chronic kidney disease ( CKD ) and cardiovascular disease ( CVD ) . Methods A cross-sectional study involving a r and om representative sample of 2270 adults from southern Spain ( Malaga ) was undertaken . We measured HbA1c , serum creatinine and albuminuria in fasting blood and urine sample s. Results Individuals without diabetes in the upper HbA1c tertile had an unfavorable cardiovascular and renal profile and shared certain clinical characteristics with the patients with diabetes . Overall , a higher HbA1c concentration was strongly associated with CKD or CVD after adjustment for traditional risk factors . The patients with known diabetes had a 2-fold higher odds of CKD or CVD . However , when both parameters were introduced in the same model , the HbA1c concentration was only significantly associated with clinical endpoints ( OR : 1.4 , 95 % CI , 1.1 - 1.6 , P = 0.002 ) . An increase in HbA1c of one percentage point was associated with a 30 % to 40 % increase in the rate of CKD or CVD . This relationship was apparent in persons with and without known diabetes . ROC curves illustrated that a HbA1c of 37 mmol/mol ( 5.5 % ) was the optimal value in terms of sensitivity and specificity for predicting endpoints in this population . Conclusion HbA1c levels were associated with a higher prevalence of CKD and CVD cross-sectionally , regardless of diabetes status . These data support the value of HbA1c as a marker of cardiovascular and renal disease in the general population BACKGROUND national policy is focused on early identification , referral and management of chronic kidney disease ( CKD ) to prevent both progression to endstage renal failure and cardiovascular disease . However , the significance of identifying CKD in older people is unclear . OBJECTIVE to determine the frequency of CKD in older people using estimated glomerular filtration rate ( eGFR ) , and its associations with morbidity and functional measures . DESIGN observational cross-sectional analysis of baseline data from a large cluster r and omised trial of health and social assessment of older people in the community .
Output:
| Conclusions The findings from this systematic review showed considerable variation in methods for sampling the general population and assessment of kidney function across studies reporting CKD prevalence .
These results are utilized to provide recommendations to help optimize both the design and the reporting of future CKD prevalence studies , which will enhance comparability of study results |
MS213421 | ***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 distinction between positive and negative training adaptation is an important prerequisite in the identification of any marker for monitoring training in athletes . To investigate the glutamine responses to progressive endurance training , twenty healthy males were r and omly assigned to a training group or a non-exercising control group . The training group performed a progressive ( 3 to 6 x 90 minute sessions per week at 70 % V.O ( 2max ) ) six-week endurance training programme on a cycle ergometer , while the control group did not participate in any exercise during this period . Performance assessment s ( V.O ( 2max ) and time to exhaustion ) and resting blood sample s ( for haemoglobin concentration , haematocrit , cortisol , ferritin , creatine kinase , glutamine , uric acid and urea analysis ) were obtained prior to the commencement of training ( Pre ) and at the end of week 2 , week 4 and week 6 . The training group showed significant improvements in time to exhaustion ( p < 0.01 ) , and V.O ( 2max ) ( p < 0.05 ) at all time points ( except week 2 for V.O ( 2max ) ) , while the control group performance measures did not change . In the training group , haemoglobin concentration and haematocrit were significantly lower ( p < 0.01 ) than pretraining values at week 2 and 4 , as percentage changes in plasma volume indicated a significant ( p < 0.01 ) haemodilution ( + 6 - 9 % ) was present at week 2 , 4 and 6 . No changes were seen in the control group . In the training group , plasma glutamine ( week 2 , 4 and 6 ) , creatine kinase ( week 2 and 4 ) , uric acid ( week 2 and 4 ) and urea ( week 2 and 4 ) all increased significantly from pretraining levels . No changes in cortisol or ferritin were found in the training group and no changes in any blood variables were present in the control group . Plasma glutamine was the only blood variable to remain significantly above pretraining ( 966 + /- 32 micromol . 1 ( -1 ) ) levels at week 6 ( 1176 + /- 24 micromol . 1 ( -1 ) ; p < 0.05 ) The elevation seen here in glutamine levels , after 6 weeks of progressive endurance training , is in contrast to previous reports of decreased glutamine concentrations in overtrained athletes . In conclusion , 6 weeks of progressive endurance training steadily increased plasma glutamine levels , which may prove useful in the monitoring of training responses Eleven men sprint trained two to three times per week for 6 wk to investigate possible exercise-induced slow-to-fast fiber type conversions . Six individuals served as controls . Both groups were tested at the beginning and end of the study to determine anaerobic performance and maximal oxygen consumption . In addition , pre- and postbiopsies were extracted from the vastus lateralis muscle and were analyzed for fiber type composition , cross-sectional area , and myosin heavy chain ( MHC ) content . No significant changes were found in anaerobic or aerobic performance variables for either group . Although a trend was found for a decrease in the percentage of type IIb fibers , high-intensity sprint cycle training caused no significant changes in the fiber type distribution or cross-sectional area . However , the training protocol did result in a significant decrease in MHC IIb with a concomitant increase in MHC IIa for the training men . These data appear to support previous investigations that have suggested exercise-induced adaptations within the fast fiber population ( IIb-->IIa ) after various types of training ( endurance and strength ) BACKGROUND Recently , there has been an increase in popularity and participation in the sport of snowshoeing . While the sport has gained considerable recognition , to date there is little or no scientific research regarding training responses to snowshoeing as a form of exercise . Therefore , the purpose of this study was to determine whether snowshoe training could improve fitness measures . A further purpose was to compare responses from a snowshoe training program to a similarly design ed run training program . METHODS This prospect i ve , comparative study was conducted with healthy males and females between the ages of 19 and 24 . These subjects were recruited from the University of Vermont population and surrounding community . Following baseline measurements in VO2max , running time to exhaustion ( RTE ) , and anthropometry , 17 subjects ( 10 snowshoers and 7 runners ) participated in a six week conditioning program . Both groups exercised for 30 min at 75 - 85 % age predicted maximum heart rate , 3 - 4 times per week , for a total of 18 sessions . RESULTS VO2max improved significantly in both running and snowshoeing groups , 6.3 and 8.5 % , respectively . Run time to exhaustion also improved significantly in both groups , 23.3 and 33.5 % , respectively . There were no changes in anthropometry for either group . With the exception of RTE , there were no statistically significant differences between groups in any other measurements at baseline . CONCLUSIONS These results support the acceptability of snowshoeing as a valid means to improve or maintain cardiovascular endurance UNLABELLED Repeated maximal-intensity short- duration exercise ( sprint interval training , SIT ) can produce muscle adaptations similar to endurance training ( ET ) despite a much reduced training volume . However , most SIT data use cycling , and little is known about its effects on body composition or maximal cardiac output ( Qmax ) . PURPOSE The purpose of this study was to assess body composition , 2000-m run time trial , VO(2max ) , and Q(max ) effects of run SIT versus ET . METHODS Men and women ( n = 10 per group ; mean ± SD : age = 24 ± 3 yr ) trained three times per week for 6 wk with SIT , 30-s all-out run sprints ( manually driven treadmill ) , four to six bouts per session , 4-min recovery per bout , versus ET , 65 % VO(2max ) for 30 to 60 min·d(-1 ) . RESULTS Training improved ( P < 0.05 ) body composition , 2000-m run time trial performance , and VO(2max ) in both groups . Fat mass decreased 12.4 % with SIT ( mean ± SEM ; 13.7 ± 1.6 to 12.0 ± 1.6 kg ) and 5.8 % with ET ( 13.9 ± 1.7 to 13.1 ± 1.6 kg ) . Lean mass increased 1 % in both groups . Time trial performance improved 4.6 % with SIT ( -25.6 ± 8.1 s ) and 5.9 % with ET ( -31.9 ± 6.3 s ) . VO(2max ) increased 11.5 % with SIT ( 46.8 ± 1.6 to 52.2 ± 2.0 mL·kg·(-1)·min(-1 ) ) and 12.5 % with ET ( 44.0 ± 2.0 to 49.5 ± 2.6 mL·kg·(-1)·min(-1 ) ) . None of these improvements differed between groups . In contrast , Q(max ) increased by 9.5 % with ET only ( 22.2 ± 2.0 to 24.3 ± 1.6 L·min(-1 ) ) . CONCLUSIONS Despite a fraction of the time commitment , run SIT induces similar body composition , VO(2max ) , and performance adaptations as ET , but with no effect on Q(max ) . These data suggest that adaptations with ET are of central origin primarily , whereas those with SIT are more PURPOSE To determine whether various intensities of aerobic training differentially affect aerobic capacity as well as resting HR and resting blood pressure ( BP ) . METHODS Sixty-one health young adult subjects were matched for sex and VO2max and were r and omly assigned to a moderate- ( 50 % VO2 reserve ( VO2R ) , vigorous ( 75 % VO2R ) , near-maximal-intensity ( 95 % VO2R ) , or a nonexercising control group . Intensity during exercise was controlled by having the subjects maintain target HR based on HR reserve . Exercise volume ( and thus energy expenditure ) was controlled across the three training groups by varying duration and frequency . Fifty-five subjects completed a 6-wk training protocol on a stationary bicycle ergometer and pre- and posttesting . During the final 4 wk , the moderate-intensity group exercised for 60 min , 4 d.wk the vigorous-intensity group exercised for 40 min , 4 d.wk and the near-maximal-intensity group exercised 3 d.wk performing 5 min at 75 % VO2R followed by five intervals of 5 min at 95 % VO2R and 5 min at 50 % VO2R . RESULTS VO2max significantly increased in all exercising groups by 7.2 , 4.8 , and 3.4 mL.min.kg in the near-maximal- , the vigorous- , and the moderate-intensity groups , respectively . Percent increases in the near-maximal- ( 20.6 % ) , the vigorous- ( 14.3 % ) , and the moderate-intensity ( 10.0 % ) groups were all significantly different from each other ( P < 0.05 ) . There were no significant changes in resting HR and BP in any group . CONCLUSION When volume of exercise is controlled , higher intensities of exercise are more effective for improving VO2max than lower intensities of exercise in healthy , young adults To determine whether high-intensity interval training ( HIT ) would increase respiratory muscle strength and expiratory flow rates more than endurance training ( ET ) , 15 physically active , healthy subjects ( untrained ) were r and omly assigned to an ET group ( n = 7 ) or a HIT group ( n = 8) . All subjects performed an incremental test to exhaustion ( VO2max ) on a cycle ergometer before and after training . St and ard pulmonary function tests , maximum inspiratory pressure ( PImax ) , maximum expiratory pressure ( PEmax ) , and maximal flow volume loops were performed pre training and after each week of training . HIT subjects performed a 4-week training program , 3 days a week , on a cycle ergometer at 90 % of their VO2max final workload , while the ET subjects performed exercise at 60–70 % VO2max . The HIT group performed five 1-min bouts with 3-min recovery periods and the ET group cycled for 45 min continuously . A five-mile time trial ( TT ) was performed prior to , after 2 weeks , and after completion of training . Both groups showed improvements ( P < 0.05 ) in VO2max ( ~8–10 % ) and TT ( HIT 6.5 ± 1.3 % , ET 4.4 ± 1.8 % ) following training with no difference ( P > 0.05 ) between groups . Both groups increased ( P < 0.05 ) PImax post training ( ET ~ 25 % , HIT ~ 43 % ) with values significantly higher for HIT than ET . There was no change ( P > 0.05 ) in expiratory flow rates with training in either group . These data suggest that both whole-body exercise training and HIT are effective in increasing inspiratory muscle strength with HIT offering a time-efficient alternative to ET in improving aerobic capacity and performance PURPOSE The present study compared the effects of aerobic endurance training at different intensities and with different methods matched for total work and frequency . Responses in maximal oxygen uptake ( VO2max ) , stroke volume of the heart ( SV ) , blood volume , lactate threshold ( LT ) , and running economy ( CR ) were examined . METHODS Forty healthy , nonsmoking , moderately trained male subjects were r and omly assigned to one of four groups:1 ) long slow distance ( 70 % maximal heart rate ; HRmax ) ; 2)lactate threshold ( 85 % HRmax ) ; 3 ) 15/15 interval running ( 15 s of running at 90 - 95 % HRmax followed by 15 s of active resting at 70 % HRmax ) ; and 4 ) 4 x 4 min of interval running ( 4 min of running at 90 - 95 % HRmax followed by 3 min of active resting at 70%HRmax ) . All four training protocol s result ed in similar total oxygen consumption and were performed 3 d.wk for 8 wk . RESULTS High-intensity aerobic interval training result ed in significantly increased VO2max compared with long slow distance and lactate-threshold training intensities ( P<0.01 ) . The percentage increases for the 15/15 and 4 x 4 min groups were 5.5 and 7.2 % , respectively , reflecting increases in V O2max from 60.5 to 64.4 mL x kg(-1 ) x min(-1 ) and 55.5 to 60.4 mL x kg(-1 ) x min(-1 ) . SV increased significantly by approximately 10 % after interval training ( P<0.05 ) . CONCLUSIONS : High-aerobic intensity endurance interval training is significantly more effective than performing the same total work at either lactate threshold or at 70 % HRmax , in improving VO2max . The changes in VO2max correspond with changes in SV , indicating a close link between the two The aim of this longitudinal study was to compare two recovery modes ( active vs. passive ) during a seven-week high-intensity interval training program ( SWHITP ) aim ed to improve maximal oxygen uptake ( $ $ \dot{V}{\text{O } } _ { { 2 { \text{max } } } } $ $ ) , maximal aerobic velocity ( MAV ) , time to exhaustion ( tlim ) and time spent at a high percentage
Output:
| There was no significant difference between tertiles in mean change in VO2max ( tertile 1:+0.29±0.15 l/min , ES ( effect size ) = 0.77 ; 2:+0.26±0.10 l/min , ES=0.68 ; 3:+0.35±0.17 l/min , ES=0.80 ) , despite significant ( p<0.05 ) reductions in session dose and total training volume as training intensity increased .
These data suggest that exercise training intensity has no effect on the magnitude of training-induced increases in maximal oxygen uptake in young healthy human participants , but similar adaptations can be achieved in low training doses at higher exercise intensities than higher training doses of lower intensity ( endurance training ) |
MS213422 | ***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: Fifty-eight patients with severe , progressive multiple sclerosis were prospect ively r and omized to one of three treatments : 20 received intravenous ACTH , 20 received high-dose intravenous cyclophosphamide plus ACTH , and 18 were placed on a regimen consisting of plasma exchange , low-dose oral cyclophosphamide , and ACTH . The three groups were similar in age , sex , duration and type of disease , and degree of disability . Before treatment and six months and one year after treatment , a disability-status score , ambulation index , and functional-status score were determined , and a quantitative neurologic examination was performed . In the ACTH group , the number of patients stabilized or improved was 8 of 20 at six months and 4 of 20 at one year ; in the cyclophosphamide-ACTH group , 18 of 20 at six months and 16 of 20 at one year ; and in the plasma exchange group , 11 of 18 at six months and 9 of 18 at one year . High-dose cyclophosphamide plus ACTH was most effective in halting progression of the disease at both 6 and 12 months ( at 12 months , cyclophosphamide-ACTH vs. ACTH , P = 0.0004 ; cyclophosphamide-ACTH vs. plasma exchange , P = 0.087 ) . Thus , progressive multiple sclerosis may be stabilized by short-term , intensive immunosuppression with cyclophosphamide plus ACTH A system has been constructed to evaluate the design , implementation , and analysis of r and omized control trials ( RCT ) . The degree of quadruple blinding ( the r and omization process , the physicians and patients as to therapy , and the physicians as to ongoing results ) is considered to be the most important aspect of any trial . The analytic techniques are scored with the same emphasis as is placed on the control of bias in the planning and implementation of the studies . Description of the patient and treatment material s and the measurement of various controls of quality have less weight . An index of quality of a RCT is proposed with its pros and cons . If published papers were to approximate these principles , there would be a marked improvement in the quality of r and omized control trials . Finally , a reasonable st and ard design and conduct of trials will facilitate the interpretation of those with conflicting results and help in making valid combinations of undersized trials Treatment with acetyl L-carnitine ( ALCAR ) has been shown to improve fatigue in patients with chronic fatigue syndrome , but there have been no trials on the effect of ALCAR for treating fatigue in multiple sclerosis ( MS ) . To compare the efficacy of ALCAR with that of amantadine , one of the drugs most widely used to treat MS-related fatigue , 36 MS patients presenting fatigue were enrolled in a r and omised , double-blind , crossover study . Patients were treated for 3 months with either amantadine ( 100 mg twice daily ) or ALCAR ( 1 g twice daily ) . After a 3-month washout period , they crossed over to the alternative treatment for 3 months . Patients were rated at baseline and every 3 months according to the Fatigue Severity Scale ( FSS ) , the primary endpoint of the study . Secondary outcome variables were : Fatigue Impact Scale ( FIS ) , Beck Depression Inventory ( BDI ) and Social Experience Checklist ( SEC ) . Six patients withdrew from the study because of adverse reactions ( five on amantadine and one on ALCAR ) . Statistical analysis showed significant effects of ALCAR compared with amantadine for the Fatigue Severity Scale ( p = 0.039 ) . There were no significant effects for any of the secondary outcome variables . The results of this study show that ALCAR is better tolerated and more effective than amantadine for the treatment of MS-related fatigue Fatigue is a complex phenomenon that , for those not affected , is hard to underst and . To achieve better assessment s , caregivers need reliable and valid tools . The aim of this study was to investigate the reliability and validity of the Swedish version of the Fatigue Impact Scale ( FIS ) among working-aged individuals diagnosed with multiple sclerosis ( MS ) , as well as in a comparative group r and omly selected from the general population in the same geographical area . Both individuals with MS ( n=161 ) and individuals recruited from the general population ( n=194 ) participated in the study . A question naire was used for the data collection . The data were analysed using non-parametric statistical methods . Reliability of FIS was addressed by item-to-item and item-to-total correlations . Concurrent validity was tested for by analysing correlations between the FIS and general questions , and construct validity by investigation of differences in the FIS scores between known groups . The FIS was found to be homogenous , with item-to-total correlation coefficients of 0.42 ≤ rs≤0.86 ( p<0.001 ) , reflecting the instrument 's reliability . The correlations between the FIS and the general questions confirm its concurrent validity , 0.27 ≤ rs≤0.84 ( p<0.001 ) . The differences in FIS scores between known groups demonstrate its construct validity . Furthermore , the FIS showed the ability to discriminate between groups of individuals with differences in perceived impact of fatigue Fatigue is a common symptom of multiple sclerosis ( MS ) that is without an effective treatment . A double-blind , controlled study of fatigue treatment was conducted to evaluate the efficacy of amantadine hydrochloride in treating MS-associated fatigue . Since fatigue can not be characterized by a single symptom or behavior , a variety of neuropsychological , behavioral , and self-report measures were used to monitor changes across different systems . According to patients ' daily diary ratings , amantadine produced small but statistically significant improvements in fatigue across four of seven dimensions ( overall energy level , concentration , problem solving , and sense of well-being ) . In addition , patients with MS who were taking amantadine performed slightly better on the Stroop Interference Test , an attentional measure of freedom from distracting information . Although retrospective reports by patients with MS did not confirm the degree of improvement recorded on a daily basis , the study 's results suggested that amantadine may offer modest benefits in alleviating the day-to-day subjective experience of fatigue As part of a larger study on the quality of life of cancer patients under treatment , the positive and negative experiences in social interaction have been examined as compared to those of a control group ( non patients , n = 201 ) . Two patient groups were included : 109 patients who had recently undergone surgery and 108 patients receiving chemotherapy . The respondents returned a mailed question naire . Contrary to the assumptions based on a review from the literature , cancer patients appear to have more positive and fewer negative social experiences than a r and om sample from the ' normal ' population . Even under more severe medical circumstances ( a poor prognosis or heavy chemotherapy , a large number of chemotherapy cycles , poor progress after surgery ) the poorer the patients , medically speaking , the more help and support they perceive . The results of this study do not support the idea of stigmatization . The personality characteristics , neuroticism and self-esteem are especially important for the having of positive and negative experiences in social interaction . Positive social experiences show a relationship with self-esteem and negative social experiences show a relationship with neuroticism In a double-blind placebo-controlled crossover study of ten patients with multiple sclerosis , we found amantadine hydrochloride therapy to be effective in improving fatigability in six . Administration of the drug was associated with significantly higher levels of beta-endorphin-beta-lipotropin and responders had significantly higher levels than nonresponders . Lactate levels were significantly higher and pyruvate levels lower in nonresponders . Amantadine given for fatigue to patients with multiple sclerosis is associated with measurable changes in levels of metabolites and peptides in the circulation Objective To determine the relative efficacy of amantadine , pemoline , and placebo in treatment of multiple sclerosis (MS)-related fatigue . Background Fatigue is a complication of MS . Both pemoline and amantadine have been used to treat MS fatigue , but their relative efficacy is not known . Methods Amantadine , pemoline , and placebo were compared in a r and omized , double-blind , placebo-controlled study using a parallel-group design . Ninety-three ambulatory MS patients completed the study . Primary outcome measures were the fatigue seventy scale ( FSS ) ; the MS-specific fatigue scale ( MS-FS ) ; and subjective response determined by verbal self-report . Secondary outcome measures consisted of assessment s of sleep , depression , and vitality . Repeated- measures analysis of variance with planned post-hoc contrasts and Fisher 's exact test were used to compare treatment response . Results Amantadine-treated patients showed a significantly greater reduction in fatigue , as measured by the MS-FS , than did patients treated with placebo ( p = 0.04 ) . By verbal report at the end of the study , 79 % of patients treated with amantadine versus 52 % treated with placebo and 32 % treated with pemoline preferred drug therapy compared with no treatment ( p = 0.03 ) . No significant differences in any primary outcome measures were noted between pemoline and placebo . Neither amantadine nor pemoline affected sleep or depression relative to placebo . Conclusion Amantadine was significantly better than placebo in treating fatigue in MS patients , whereas pemoline was not . The benefit of amantadine was not due to changes in sleep , depression , or neurologic disability We investigated the effect of amantadine on cognitive processing in patients with multiple sclerosis ( MS ) and fatigue with objective electrophysiological measures . Behavioral methods ( Reaction Time , RT ) and two different Event Related Potential ( ERP ) components measuring i ) stimulus selection ( Selection Negativity , SN ) and ii ) response selection ( Lateralized Readiness Potential , LRP ) were employed . Twenty-four patients with clinical definite MS ( 10 relapsing remitting and 14 secondary progressive ) and confirmed fatigue in the past three months ( Fatigue Severity Scale ( FSS ) > 4 ) were included . Patients were r and omized in a double-blind , placebo-controlled cross-over design . We found a difference between the two treatments for ERP measures to stimuli with relevant colour starting at about 200 ms . This negativity had a higher amplitude during amantadine treatment regardless of treatment order . The RT did not differ significantly between the treated and untreated groups . Additional analysis indicated that patients with a disease duration of less than 7 years had a significant test position ( practice effect ) , but no treatment effect , while patients with a longer MS duration showed no practice effect , but rather an improved reaction speed and increased ERP amplitude effects when treated with amantadine . The present findings suggest that amantadine exerts beneficial effects on early cognitive processes in patients with MS , but appears to be limited to subjects with a longer duration of the disease BACKGROUND Amantadine hydrochloride and pemoline , both frequently used to treat the fatigue of multiple sclerosis ( MS ) , may also improve attention and other cognitive functions in MS . To our knowledge , these agents have never been compared in a placebo-controlled trial of patients with MS . OBJECTIVE To evaluate the effects of amantadine and pemoline on cognitive functioning in MS . METHODS A total of 45 ambulatory patients with MS and severe fatigue were treated for 6 weeks with amantadine , pemoline , or placebo using a parallel group design . They underwent comprehensive neuropsychological testing to determine treatment effects on cognitive functioning . Primary outcome measures were tests of attention ( Digit Span , Trail Making Test , and Symbol Digit Modalities Test ) , verbal memory ( Selective Reminding Test ) , nonverbal memory ( Benton Visual Retention Test ) , and motor speed ( Finger Tapping Test ) . RESULTS Fatigue did not significantly correlate with any of the neuropsychological outcome measures at baseline or after treatment . All three treatment groups improved on tests of attention ( P < .003 ) , verbal memory ( P < .001 ) , and motor speed ( P < .002 ) . There were no significant differences between amantadine , pemoline , and placebo . CONCLUSIONS Cognitive functioning in MS is independent of fatigue . Neither amantadine nor pemoline enhances cognitive performance in MS compared with placebo We carried out a double blind control study of fatigue in 32 patients with multiple sclerosis , comparing amantadine hydrochloride 100 mg twice a day and placebo . On amantadine 31 % had marked improvement ; 15.6 % moderate improvement ; 15.6 % mild improvement ; and 36.5 % unchanged . On placebo , none noted marked improvement ; one cl aim ed moderate improvement on either amantadine or placebo . 18.7 % reported mild improvement on placebo ; and most of them had similar or more response to amantadine . No patient selected placebo over amantadine at the end of the trial . Overall improvement was seen in 62.5 % of patients on amantadine and 21.8 % on placebo . Additional experience up to two years suggests continued benefit but common and important side-effects During a study of efficacy of amantadine prophylaxis of influenza A virus infection in young adults , gross and subtle side effects were monitored . Eighty-eight students were r and omly selected to receive either amantadine or placebo for four weeks or both in a sequential crossover design of two weeks each . Side effects ( i.e. , dizziness , nervousness , and insomnia ) occurred in 33 % of those receiving amantadine and in 10 % of those receiving placebo ( P less than 0.005 ) . Although side effects were well tolerated by most subjects , six volunteers discontinued amantadine because of marked complaints . Cessation of side effects occurred in more than half of those continuing amantadine . Sixteen students receiving amantadine had decreased performance on sustained attention tasks as compared with ones receiving placebo ( P less than 0.05 ) .
Output:
| All studies reported small and inconstant improvements in fatigue , whereas the clinical relevance of these findings and the impact on patient 's functioning and health related quality of life remains undetermined . |
MS213423 | ***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 —Although statins are efficacious for lowering low-density lipoprotein cholesterol , there is wide interindividual variation in response . We tested the extent to which combined effects of common alleles of LDLR and HMGCR can contribute to this variability . Methods and Results —Haplotypes in the LDLR 3′-untranslated region ( 3-UTR ) were tested for association with lipid-lowering response to simvastatin treatment in the Cholesterol and Pharmacogenetics trial ( 335 blacks and 609 whites ) . LDLR haplotype 5 ( LDLR L5 ) was associated with smaller simvastatin-induced reductions in low-density lipoprotein cholesterol , total cholesterol , non-high-density lipoprotein cholesterol , and apolipoprotein B ( P=0.0002 to 0.03 ) in blacks but not whites . The combined presence of LDLR L5 and previously described HMGCR haplotypes in blacks was associated with significantly attenuated apolipoprotein B reduction ( −22.4±1.5 % , N=89 ) compared with both noncarriers ( −30.6±1.5 % , N=78 , P=0.0001 ) and carriers of either individual haplotype ( −28.2±1.1 % , N=158 , P=0.001 ) . We observed similar differences when measuring simvastatin-mediated induction of low-density lipoprotein receptor surface expression using lymphoblast cell lines ( P=0.03 ) . Conclusion —We have identified a common LDLR 3-UTR haplotype that is associated with attenuated lipid-lowering response to simvastatin treatment . Response was further reduced in individuals with both LDLR and previously described HMGCR haplotypes . Previously identified racial differences in statin efficacy were partially explained by the greater prevalence of these combined haplotypes in blacks In vitro data indicate that biotransformation of the synthetic 3‐hydroxy‐3‐methylglutaryl – coenzyme A reductase inhibitor fluvastatin is catalyzed by the cytochrome P450 ( CYP ) enzyme 2C9 . The consequences of CYP2C9 genetic polymorphisms on fluvastatin pharmacokinetics and on its efficacy have not been investigated in humans thus far Background — Hypothesis-generating data raise the possibility that carriers of the kinesin-like protein 6 ( KIF6 ) 719 arginine ( Arg ) allele preferentially benefit from statin therapy , and , on this basis , a commercial assay for KIF6 has been developed . Methods and Results — In the recently completed JUPITER trial , men and women without prior cardiovascular disease or diabetes who had baseline low-density lipoprotein cholesterol < 130 mg/dL and high-sensitivity C-reactive protein ≥2 mg/L were r and omly allocated to rosuvastatin 20 mg daily or to placebo and followed for first major vascular events ( nonfatal myocardial infa rct ion , nonfatal stroke , hospitalization for unstable angina , arterial revascularization , or vascular death ) and for all-cause mortality . We evaluated the effect of polymorphism at rs20455 encoding the KIF6 719Arg allele on outcomes in this primary prevention trial , both among Caucasian participants and in the trial as a whole . Among 8781 Caucasian trial participants , we observed no increase in vascular event rates among carriers of the KIF6 719Arg allele as compared with noncarriers ( hazard ratio , 0.91 ; 95 % confidence interval , 0.66 to 1.26 ) nor any difference in percent low-density lipoprotein cholesterol reduction with rosuvastatin according to genotype ( −52 versus −52 mg/dL , P=0.11 ) . Rosuvastatin allocation was associated with an almost identical reduction in the trial primary end point among carriers ( hazard ratio , 0.61 ; 95 % confidence interval , 0.43 to 0.87 ) as among noncarriers ( hazard ratio , 0.59 ; 95 % confidence interval , 0.39 to 0.88 ) ( P-interaction=0.90 ) . Genotype had no impact on rosuvastatin efficacy in further analyses that included all-cause mortality , in analyses conducted in the total trial cohort that adjusted for race , or in analyses using generalized models of inheritance rather than recessive models . Conclusions — In the large primary prevention JUPITER trial , rosuvastatin was equally effective at reducing cardiovascular event rates among carriers and noncarriers of the KIF6 719Arg allele . Thus , at least for rosuvastatin , there appears to be no clinical utility to screening for KIF6 genotype as a method to determine vascular risk or to predict statin efficacy . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00239681 OBJECTIVE To investigate whether ScrF I polymorphism in the 2nd intron of the HMG-COA reductase gene ( HMGCR ) influences serum lipid levels and whether this polymorphism affects the efficiency of the cholesterol lowering HMG-CoA reductase inhibitor , simvastatin . METHODS One hundred sixty-eight patients with type 2 diabetes mellitus ( T2DM ) prospect ively received simvastatin as a single-agent therapy ( 20 mg day-1 p.o . ) for 12 weeks . Serum lipid levels were determined before and after simvastatin treatment . Genotyping was performed by polymerase chain reaction-restriction fragment length polymorphism ( PCR-RFLP ) . RESULTS Subjects with the AA homozygotes had significantly higher serum very low-density lipoprotein cholesterol ( VLDL-C ) levels than those with the aa homozygotes . In addition , in 168 patients with T2DM who took 20 mg simvastatin , the VLDL-C lowering effect by simvastatin in subjects with the aa homozygotes was significantly lower than in those with the Aa heterozygotes and AA homozygotes . CONCLUSIONS Simvastatin treatment significantly decreased plasma lipids in all patients ( P<0.01 ) . Importantly , we demonstrate that ScrF I polymorphism of the HMGCR gene in patients with T2DM groups is associated with significant elevation of serum VLDL-C levels . Subjects with the AA homozygotes had significantly higher serum high VLDL-C levels than those with the Aa heterozygotes and aa homozygotes ( AA : 2.18+/-0.51 ; Aa : 2.04+/-0.59 , aa : 1.86+/-0.43 , P<0.05 for comparison among three genotypes and P<0.01 for difference between AA and aa ) . Furthermore , this polymorphism tends to show an enhanced response to an HMG-CoA reductase inhibitor in terms of the cholesterol-lowering effect . In 168 patients with T2DM who took 20 mg simvastatin , the VLDL-C lowering effect by simvastatin in subjects with the AA homozygotes was significantly lower than in those with the Aa heterozygotes and aa homozygotes ( the reduction in serum VLDL-C levels ; 37.03+/-5.67 versus 28.97+/-4.96 , P<0.01 ; 34.62+/-5.87 versus 28.97+/-4.96 , P<0.05 ) . These results suggest that the HMGCR gene may serve as a modifier gene for hypercholesterolemia in Chinese diabetic patients We carried out a genome-wide association study ( GWAS ) of LDL-c response to statin using data from participants in the Collaborative Atorvastatin Diabetes Study ( CARDS ; n = 1,156 ) , the Anglo-Sc and inavian Cardiac Outcomes Trial ( ASCOT ; n = 895 ) , and the observational phase of ASCOT ( n = 651 ) , all of whom were prescribed atorvastatin 10 mg . Following genome-wide imputation , we combined data from the three studies in a meta- analysis . We found associations of LDL-c response to atorvastatin that reached genome-wide significance at rs10455872 ( P = 6.13 × 10−9 ) within the LPA gene and at two single nucleotide polymorphisms ( SNP ) within the APOE region ( rs445925 ; P = 2.22 × 10−16 and rs4420638 ; P = 1.01 × 10−11 ) that are proxies for the ε2 and ε4 variants , respectively , in APOE . The novel association with the LPA SNP was replicated in the PROspect i ve Study of Pravastatin in the Elderly at Risk ( PROSPER ) trial ( P = 0.009 ) . Using CARDS data , we further showed that atorvastatin therapy did not alter lipoprotein(a ) [ Lp(a ) ] and that Lp(a ) levels accounted for all of the associations of SNPs in the LPA gene and the apparent LDL-c response levels . However , statin therapy had a similar effect in reducing cardiovascular disease ( CVD ) in patients in the top quartile for serum Lp(a ) levels ( HR = 0.60 ) compared with those in the lower three quartiles ( HR = 0.66 ; P = 0.8 for interaction ) . The data emphasize that high Lp(a ) levels affect the measurement of LDL-c and the clinical estimation of LDL-c response . Therefore , an apparently lower LDL-c response to statin therapy may indicate a need for measurement of Lp(a ) . However , statin therapy seems beneficial even in those with high Lp(a ) BACKGROUND Although statin therapy is known to increase concentrations of PCSK9 , whether this effect is related to the magnitude of LDL reduction is uncertain . This study was undertaken to underst and the extent of this effect and examine the relationship between PCSK9 and LDL cholesterol ( LDL-C ) reduction . METHODS We measured plasma PCSK9 concentrations by ELISA at baseline and at 1 year in 500 men and 500 women participating in the Justification for Use of Statins in Prevention : an Intervention Trial Evaluating Rosuvastatin ( JUPITER ) trial that r and omly allocated participants to rosuvastatin 20 mg daily or placebo . We also evaluated rs11591147 , a single nucleotide polymorphism known to have an impact on plasma PCSK9 concentrations . RESULTS At baseline , median ( interquartile range ) PCSK9 concentrations were higher in women [ 73 ( 62 - 90 ) ] ng/mL than in men [ 69 ( 57 - 81 ) ng/mL ] ( P<0.005 ) . During 1 year , there was no change in PCSK9 concentrations in the placebo arm , suggesting stability in time . In contrast , the rosuvastatin increased PCSK9 by 35 % in women [ 101 ( 82 - 117 ) ng/mL ] and 28 % in men [ 89 ( 71 - 109 ) ng/mL ] ( P<0.0001 ) . Among those allocated to rosuvastatin , greater reductions in LDL-C were associated with greater increases in PCSK9 on both absolute and relative scales ( r=-0.15 , P<0.0005 ) . Furthermore PCSK9 ( rs11591147 ) did not alter the magnitude of LDL-C reduction associated with rosuvastatin use . CONCLUSIONS In this r and omized trial , rosuvastatin increased plasma concentration of PCSK9 in proportion to the magnitude of LDL-C reduction ; the LDL-C response to statin could not be inferred by PCSK9 concentrations Background Statins effectively lower total and plasma LDL-cholesterol , but the magnitude of decrease varies among individuals . To identify single nucleotide polymorphisms ( SNPs ) contributing to this variation , we performed a combined analysis of genome-wide association ( GWA ) results from three trials of statin efficacy . Methods and Principal Findings Bayesian and st and ard frequentist association analyses were performed on untreated and statin-mediated changes in LDL-cholesterol , total cholesterol , HDL-cholesterol , and triglyceride on a total of 3932 subjects using data from three studies : Cholesterol and Pharmacogenetics ( 40 mg/day simvastatin , 6 weeks ) , Pravastatin/Inflammation CRP Evaluation ( 40 mg/day pravastatin , 24 weeks ) , and Treating to New Targets ( 10 mg/day atorvastatin , 8 weeks ) . Genotype imputation was used to maximize genomic coverage and to combine information across studies . Phenotypes were normalized within each study to account for systematic differences among studies , and fixed-effects combined analysis of the combined sample were performed to detect consistent effects across studies . Two SNP associations were assessed as having posterior probability greater than 50 % , indicating that they were more likely than not to be genuinely associated with statin-mediated lipid response . SNP rs8014194 , located within the CLMN gene on chromosome 14 , was strongly associated with statin-mediated change in total cholesterol with an 84 % probability by Bayesian analysis , and
Output:
| None of the investigated SNPs consistently affected the risk reduction for cardiovascular events .
However , as effect sizes are modest , there is no evidence for the value of genetic testing in clinical practice |
MS213424 | ***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 Evaluate the effect of high-oleic and conventional peanuts within a hypocaloric-diet on energy metabolism and body composition . METHODS This 4-week r and omized clinical trial included males with BMI of 29.7 ± 2.4 kg m(-2 ) and aged between 18 and 50 years . Participants were assigned to the groups : control ( CT , n = 22 ) that followed a hypocaloric-diet ; conventional peanuts ( CVP , n = 22 ) or high-oleic peanuts ( HOP , n = 21 ) that received the hypocaloric-diet including ( not adding ) 56 g day(-1 ) of peanuts . Glucose , fat oxidation , and body fatness and lean mass were the main outcomes . RESULTS Body weight and composition did not differ between groups . However , within group total body fat ( kg ) reduced with CVP and HOP , with a significant decrease in body fat percentage in HOP . While total lean mass ( kg ) decreased in CT , total lean mass ( % ) increased in HOP . Truncal lean mass decreased in the CT . At baseline , HOP had greater postpr and ial fat oxidation than the CVP . After 4-weeks , fasting fat oxidation increased in CVP and HOP . Fat oxidation increased in CT and HOP during the 200 min after meal intake compared to the fasting condition . CONCLUSION Regular peanut consumption , especially the high-oleic type , within a hypocaloric-diet increased fat oxidation and reduced body fatness in overweigh and obese men BACKGROUND Data concerning the long-term association between nut consumption and weight change in a free-living population are sparse . OBJECTIVE The objective was to determine the relation between nut consumption and long-term weight change . DESIGN The participants were 51,188 women in the Nurses ' Health Study II aged 20 - 45 y , who had no cardiovascular disease , diabetes , or cancer . We prospect ively evaluated the dietary intake of nuts and subsequent weight changes from 1991 to 1999 . RESULTS Women who reported eating nuts > or = 2 times/wk had slightly less mean ( + /- SE ) weight gain ( 5.04 + /- 0.12 kg ) than did women who rarely ate nuts ( 5.55 + /- 0.04 kg ) ( P for trend < 0.001 ) . For the same comparison , when total nut consumption was subdivided into peanuts and tree nuts , the results were similar ( ie , less weight gain in women eating either peanuts or tree nuts > or = 2 times/wk ) . The results were similar in normal-weight , overweight , and obese participants . In multivariate analyses in which lifestyle and other dietary factors were controlled for , we found that greater nut consumption ( > or = 2 times/wk compared with never/almost never ) was associated with a slightly lower risk of obesity ( hazard ratio : 0.77 ; 95 % CI : 0.57 , 1.02 ; P for trend = 0.003 ) . CONCLUSIONS Higher nut consumption was not associated with greater body weight gain during 8 y of follow-up in healthy middle-aged women . Instead , it was associated with a slightly lower risk of weight gain and obesity . The results of this study suggest that incorporating nuts into diets does not lead to greater weight gain and may help weight control Regular nut consumption is associated with lower adiposity and reduced weight gain in adulthood . Walnut feeding studies have observed minimal effect on body weight despite potential additional energy intake . Several mechanisms may explain why consuming nuts promotes weight control , including increased early phase satiety , possibly reflected in postpr and ial response of gastrointestinal and pancreatic peptides hypothesized to affect appetite . The purpose of this study was to compare postpr and ial insulin , glucagon and gastrointestinal peptide response and satiety following a meal with ~54 % of energy from walnuts or cream cheese , using a within-subject crossover study design in overweight/obese adults ( N = 28 ) . Sixty minutes after the walnut-containing meal , glucagon-like peptide-1 was lower than after the reference meal ( p=0.0433 ) , and peptide YY , cholecystokinin and ghrelin did not differ after the two meals . Sixty and 120 min after the walnut-containing meal , pancreatic polypeptide ( p = 0.0014 and p = 0.0002 ) and glucose-dependent insulinotropic peptide ( p < 0.0001 and p = 0.0079 ) were lower than after the reference meal , and 120 min after the walnut-containing meal , glucagon was higher ( p=0.0069 ) . Insulin and C-peptide increased at 60 min in response to both meals but were lower at 120 min after the walnut-containing meal ( p=0.0349 and 0.0237 , respectively ) . Satiety measures were similar after both meals . These findings fail to support the hypothesis that acute postpr and ial gastrointestinal peptide response to a walnut-containing meal contributes to increased satiety . However , inclusion of walnuts attenuated the postpr and ial insulin response , which may contribute to the more favorable lipid profile observed in association with regular walnut consumption Nut consumption is associated with a reduced risk of type 2 diabetes mellitus ( T2DM ) . The aim of the present study was to assess the effects of adding peanuts ( whole or peanut butter ) on first ( 0 - 240 min)- and second ( 240 - 490 min)-meal glucose metabolism and selected gut satiety hormone responses , appetite ratings and food intake in obese women with high T2DM risk . A group of fifteen women participated in a r and omised cross-over clinical trial in which 42·5 g of whole peanuts without skins ( WP ) , peanut butter ( PB ) or no peanuts ( control ) were added to a 75 g available carbohydrate-matched breakfast meal . Postpr and ial concentrations ( 0 - 490 min ) of glucose , insulin , NEFA , glucagon-like peptide-1 ( GLP-1 ) , peptide YY ( PYY ) , cholecystokinin ( CCK ) , appetitive sensations and food intake were assessed after breakfast treatments and a st and ard lunch . Postpr and ial NEFA incremental AUC ( IAUC ) ( 0 - 240 min ) and glucose IAUC ( 240 - 490 min ) responses were lower for the PB breakfast compared with the control breakfast . Insulin concentrations were higher at 120 and 370 min after the PB consumption than after the control consumption . Desire-to-eat ratings were lower , while PYY , GLP-1 and CCK concentrations were higher after the PB intake compared with the control intake . WP led to similar but non-significant effects . The addition of PB to breakfast moderated postpr and ial glucose and NEFA concentrations , enhanced gut satiety hormone secretion and reduced the desire to eat . The greater bioaccessibility of the lipid component in PB is probably responsible for the observed incremental post-ingestive responses between the nut forms . Inclusion of PB , and probably WP , to breakfast may help to moderate glucose concentrations and appetite in obese women Nuts have high energy and fat contents , but nut intake does not promote weight gain or obesity , which may be partially explained by their proposed high satiety value . The primary aim of this study was to assess the effects of consuming almonds versus a baked food on postpr and ial appetite and neural responses to visual food stimuli . Twenty-two adults ( 19 women and 3 men ) with a BMI between 25 and 40 kg/m2 completed the current study during a 12-week behavioral weight loss intervention . Participants consumed either 28 g of whole , lightly salted roasted almonds or a serving of a baked food with equivalent energy and macronutrient contents in r and om order on two testing days prior to and at the end of the intervention . Pre- and postpr and ial appetite ratings and functional magnetic resonance imaging scans were completed on all four testing days . Postpr and ial hunger , desire to eat , fullness , and neural responses to visual food stimuli were not different following consumption of almonds and the baked food , nor were they influenced by weight loss . These results support energy and macronutrient contents as principal determinants of postpr and ial appetite and do not support a unique satiety effect of almonds independent of these variables Purpose Almonds have shown to beneficially modify some cardiovascular risk factors in clinical trials conducted in diverse ethnic population s but this relationship has never been tested in Koreans . Thus , we tested the impact of almonds consumed as a snack within the context of a typical Korean diet on cardiovascular risk factors . Methods We conducted a r and omized , crossover trial in a free-living setting with a 2-week run-in period , two 4-week intervention phases , and a 2-week washout period between interventions . Eighty four overweight/obese participants ( 11 M/73 F ; 52.4 ± 0.6 year ; 25.4 ± 0.22 kg/m2 ) consumed either 56 g of almonds or isocaloric cookies daily for 4 weeks . Results Mean % daily energy intake at baseline was 64.8 , 21.3 , and 14.9 % from carbohydrate , fat , and protein , respectively . The addition of 56 g of almonds daily decreased carbohydrate energy to 55.0 % , increased fat to 32.0 % , and maintained protein at 14.7 % . Consuming the almonds increased intake of MUFA by 192.3 % , PUFA by 84.5 % , vitamin E by 102.7 % , and dietary fiber by 11.8 % and decreased % energy from carbohydrate by 14.1 % . Total caloric intake was increased by the almonds , but body weight , waist circumference , and body composition were not affected . Almonds in overweight and obese Korean adults decreased TC , LDL-C , and non-HDL-C by 5.5 , 4.6 , and 6.4 % , respectively , compared to the cookie control ( P ≤ 0.05 ) . Almonds increased plasma α-tocopherol by 8.5 % ( P ≤ 0.05 ) from the baseline and tended to increase its value as compared to cookies ( P = 0.055 ) . Neither the almonds nor cookies altered plasma protein carbonyls , MDA or oxLDL . Of serum inflammatory markers , IL-10 was decreased by almond intake ( P ≤ 0.05 ) , and ICAM-1 , IL-1β , and IL-6 tended to be lower with almonds , compared to the cookies . Conclusions Almonds at 56 g/day consumed as a snack favorably modified the Korean diet by increasing MUFA , PUFA , vitamin E , and dietary fiber intake and decreasing % energy intake from carbohydrate . Almonds also enhanced plasma α-tocopherol status and serum TC and LDL-C in overweight and obese Koreans . Thus , including almonds in typical Korean diets as a snack can help healthy overweight/obese individuals improve nutritional status and reduce their risk for CVD Nut consumption has been associated with reduced coronary heart disease ( CHD ) risk . In addition to cholesterol-lowering properties , almonds have been shown to lower oxidized LDL concentrations . However , little is known regarding their effects on other markers of oxidative stress . The dose-response effects of whole almonds , taken as snacks , were compared with low-saturated fat ( < 5 % energy ) whole-wheat muffins ( control ) in the therapeutic diets of hyperlipidemic subjects . In a r and omized crossover study , 27 hyperlipidemic men and women consumed 3 isoenergetic ( mean 423 kcal/d or 1770 kJ/d ) supplements each for 1 mo . Supplements consisted of full-dose almonds ( 73 + /- 3 g/d ) , half-dose almonds plus half-dose muffins ( half-dose almonds ) , and full-dose muffins ( control ) . Subjects were assessed at wk 0 , 2 and 4 . Mean body weights differed < or = 300 g between treatments , although the weight loss on the half-dose almond treatment was greater than on the control ( P < 0.01 ) . At 4 wk , the full-dose almonds reduced serum concentrations of malondialdehyde ( MDA ) ( P = 0.040 ) and creatinine-adjusted urinary isoprostane output ( P = 0.026 ) compared with the control . Serum concentrations of alpha- or gamma-tocopherol , adjusted or unadjusted for total cholesterol , were not affected by the treatments . Almond antioxidant activity was demonstrated by their effect on 2 biomarkers of lipid peroxidation , serum MDA and urinary isoprostanes , and supports the previous finding that almonds reduced oxidation of LDL-C. Antioxidant activity provides an additional possible mechanism , in addition to lowering cholesterol , that may account for the reduction in CHD risk with nut consumption The aim of the study was to evaluate the effect of preloads differing in fatty acid composition , content , and delivery form on ac
Output:
| Nuts did not affect sense of fullness and weight in the overall estimate .
Subgroup analysis based on participants ’ BMI revealed that energy intake of overweight/obese individuals was increased following nut consumption while such effect was not observed in normal weight participants .
In conclusion , pooled estimates of available clinical trials showed increased energy intake following nut consumption in overweight/obese individuals but not in persons with normal weight .
Nut consumption was associated with decreased hunger but no effect was observed on fullness and weight |
MS213425 | ***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 / aims To determine the changes in the incidence of diabetic retinopathy ( DR ) , diabetic macular oedema ( DMO ) and their risk factors in a population -based study of patients with diabetes mellitus ( DM ) referred to our 16 Primary Health Care Areas ( HCAs ) . Methods Prospect i ve population -based study of a total of 15 396 Caucasian patients with DM , who represent 86.53 % of the total patients with DM in our HCAs , were studied over an 8-year follow-up period . All patients were screened with a mean follow-up of 3.18±1.11 times for each patient over the 8 years . Results The yearly mean value of any DR was 8.37±2.19 % ( 8.09%–8.99 % ) ; of advanced DR yearly mean value of 0.46±0.22 % ( 0.03–0.78 ) ; and of DMO a yearly mean value of 2.19±0.18 % ( 2%–2.49 % ) . A clear increase was observed in the last 3 years , any DR increased from 8.09 % in 2007 to 8.99 % in 2014 , and DMO from 2 % in 2007 to 2.49 % in 2014 . These increases were more evident in some age groups . For patients with any DR aged 41–50 and 51–60 and for patients with advanced DR aged 41–50 , 51–60 and 61–70 , the increase was more marked , related to an increase in HbA1c values or to patients treated with insulin . Conclusions An increase in the incidence of DR and DMO was observed , especially in the younger patients aged between 31 and 70 years . This is linked to bad metabolic control of DM . Our results suggest a greater number of ocular complications in the near future , such as neovascular glaucoma , if these current findings are not addressed Aims To extrapolate , from the proportion of subjects with observable retinopathy at diagnosis of type 2 diabetes mellitus in routine clinical practice , the mean duration of undiagnosed diabetes . Methods On 1 October 1999 , there were 4313 patients with type 2 diabetes in the 41 participating practice s in the Tayside region ( registered with one of 166 GPs ) . 501 ( 12 % ; 95 % CI 11 to 13 % ) patients were selected using a pseudo-r and om number allocation algorithm , and practice lists checked for recently deceased , non-residents ( 45 exclusions ) . Retinopathy was grade d by vali date d slit lamp biomicroscopy and four-field stereo photography . Date of first diagnosis of diabetes was ascertained from the regional diabetes register created using multiple source data capture . Results Of living Tayside resident patients , 295 from 456 invited type 2 patients ( 65 % ) were examined . 14.68 % ( 95 % CI 12.48 to 16.88 % ) were found to have retinopathy at diagnosis . Assuming a linear model , these data suggest that the onset of detectable retinopathy occurs 5.77 years ( 95 % CI 4.6 to 7 years ) before diagnosis . Comparison using the log rank test with survival to onset of sight threatening retinopathy/maculopathy in 291 patients with type 1 diabetes mellitus also examined from the same population cohort showed the 95 % CIs of length of pre clinical diabetes to be between 3.0 and 9.4 years . Conclusion There is accumulating evidence to question the assumption of linearity as a model of choice . The authors ' underst and ing of a distinct glycaemic threshold for retinal change is also overly simplistic and consequently the bounds of uncertainty concerning the pre clinical duration of disease are considerable Objective To evaluate the incidence of diabetic retinopathy in patients with Type 2 Diabetes Mellitus , to identify the risk factors associated with the incidence of retinopathy and to develop a risk table to predict four-year retinopathy risk stratification for clinical use , from a four-year cohort study . Design The MADIABETES Study is a prospect i ve cohort study of 3,443 out patients with Type 2 Diabetes Mellitus , sample d from 56 primary health care centers ( 131 general practitioners ) in Madrid ( Spain ) . Results The cumulative incidence of retinopathy at four-year follow-up was 8.07 % ( 95 % CI = 7.04–9.22 ) and the incidence density was 2.03 ( 95 % CI = 1.75–2.33 ) cases per 1000 patient-months or 2.43 ( 95 % CI = 2.10–2.80 ) cases per 100 patient-years . The highest adjusted hazard ratios of associated risk factors for incidence of diabetic retinopathy were LDL-C > 190 mg/dl ( HR = 7.91 ; 95 % CI = 3.39–18.47 ) , duration of diabetes longer than 22 years ( HR = 2.00 ; 95 % CI = 1.18–3.39 ) , HbA1c>8 % ( HR = 1.90 ; 95 % CI = 1.30–2.77 ) , and aspirin use ( HR = 1.65 ; 95 % CI = 1.22–2.24 ) . Microalbuminuria ( HR = 1.17 ; 95 % CI = 0.75–1.82 ) and being female ( HR = 1.12 ; 95 % CI = 0.84–1.49 ) showed a non-significant increase of diabetic retinopathy . The greatest risk is observed in females who had diabetes for more than 22 years , with microalbuminuria , HbA1c>8 % , hypertension , LDL-Cholesterol > 190 mg/dl and aspirin use . Conclusions After a four-year follow-up , the cumulative incidence of retinopathy was relatively low in comparison with other studies . Higher baseline HbA1c , aspirin use , higher LDL-Cholesterol levels , and longer duration of diabetes were the only statistically significant risk factors found for diabetic retinopathy incidence . This is the first study to demonstrate an association between aspirin use and diabetic retinopathy risk in a well-defined cohort of patients with Type 2 Diabetes Mellitus at low risk of cardiovascular events . However , further studies with patients at high cardiovascular and metabolic risk are needed to clarify this issue OBJECTIVE To establish the prevalence of diabetic retinopathy ( DR ) , types and risk factors in a diabetic population in the city of Badajoz . METHODS A cross-sectional study , with prospect i ve data collection , was performed in 2002 on 762 r and omly selected diabetic patients belonging to two Primary Care Centers . We evaluated age , gender , type , treatment , duration of diabetes and blood pressure levels . Two color fundus photographs were taken and ophthalmoscopy performed on both eyes . Data were analyzed using SPSS ( 11.5 ) . RESULTS The mean age of the patients was 66.2 ( DS 11.4 ) years , 4.7 % were type 1 diabetics , 29 % were insulin-treated and 52.8 % had elevated blood pressure . Prevalence of DR was 29.8 % , macular edema 1.4 % and proliferative DR 4.8 % . Multivariate analysis showed that patients with an evolution of between 5 and 10 years had a frequency 1.13 times higher ( ORaj 1.13 ; IC 95 % 0.68 - 1.88 ; p=0.648 ) than those of less than 5 years evolution , while those with more than 15 years evolution had a frequency 3.12 times higher ( ORaj 3.12 ; IC 95 % 1.85 - 5.26 ; p<0.001 ) . Patients receiving treatment with oral antidiabetic agents had an RD prevalence 2.39 times higher ( ORaj 2.39 ; IC 95 % 1.21 - 4.74 ; p=0,012 ) than those treated with diet only . Patients treated with insulin had a 10.32 higher frequency ( ORaj 10.32 ; IC 95 % 5.07 - 21.00 ; p<0.001 ) than those treated with diet . CONCLUSIONS 29.8 % of the diabetic population in the city of Badajoz is affected by DR . Although this prevalence is lower than that observed in previous studies performed by the same team , further studies should be carried out to detect risk sub-groups to allow us to act to decrease such a high prevalence Purpose To investigate the prevalence and risk factors of diabetic retinopathy in subjects aged 40 years or older living in Casteldaccia , Sicily . Methods A population -based survey was performed on 1,588 subjects r and omly enrolled among people aged 40 years or older . A total of 1,068 persons could be examined and in 1,019 the fundus of the eye was adequately observed ( 64.2 % of the enrolled population ) . Diabetic retinopathy was diagnosed by ophthalmoscopy and fundus photographs ; fluorescein angiography was performed in 91 % of retinopathic subjects . In addition , a case – control study was carried out in order to demonstrate the association of diabetic retinopathy with a number of variables . Results Diabetic retinopathy was found in 4.4 % of the whole population studied and in 34.1 % of the diabetics . Nonproliferative diabetic retinopathy was found in 29.6 % and proliferative diabetic retinopathy in 4.5 % of the diabetics . Diabetic retinopathy was significantly associated with the following univariate variables : duration of diabetes , duration and type of antidiabetic treatment , and duration of alcohol intake . After multivariate logistic regression the only variable independently associated with diabetic retinopathy was duration of antidiabetic treatment . Conclusion Diabetic retinopathy affects more than one third of diabetics and represents a leading cause of retinal disease . The antidiabetic treatment is the most important risk factor for diabetic retinopathy , even stronger than the duration of diabetes OBJECTIVE To determine the prevalence of diabetic retinopathy ( DR ) and evaluate our experience in DR screening in a study carried out between the Ophthalmology Department of the University General Hospital of Alicante and Department 19 Primary Care of Alicante by using a non-retinal mydriatic camera and telemedicine . MATERIAL AND METHODS A descriptive , cross-sectional study was conducted on 2,435 diabetic patients from 1 February 2006 to 1 February 2009 . Three 45 ° retinographies of both eyes of each patient were obtained and sent to the Department of Ophthalmology via the hospital intranet . These were then evaluated by 2 ophthalmologists , experts in the retina , with each issuing an individualized report for each patient . RESULTS The prevalence of DR was 17.90 % , with 80.73 % of them having mild-moderate proliferative DR , 12.16 % severe non-proliferative DR , 2.29 % proliferative DR , and 4.82 % with diabetic maculopathy associated with any level of retinopathy . The retinographies were considered low quality in 41 patients ( 1.69 % ) . CONCLUSIONS We highlight the benefits of the tele-ophthalmology in screening diabetic patients to enable early diagnosis and treatment , and improving the circuit of communication between primary and specialist care OBJECTIVES To report on the prevalence of retinopathy in patients with newly diagnosed non-insulin-dependent diabetes mellitus ( NIDDM ) and to evaluate the relationship of retinopathy to clinical and biochemical variables . DESIGN A multicenter , r and omized , controlled clinical study of therapy in patients with NIDDM . SETTING AND PATIENTS Patients were part of the United Kingdom Prospect i ve Diabetes Study , a 23-center study of 2964 white patients who had both eyes photographed and assessed . OUTCOME MEASURES The presence and severity of diabetic retinopathy were evaluated by sex , and the relationship of retinopathy to medical and biochemical parameters was assessed . RESULTS Retinopathy , defined as microaneurysms or worse lesions in at least 1 eye , was present in 39 % of men and 35 % of women . Marked retinopathy with cotton wool spots or intraretinal microvascular abnormalities was present in 8 % of men and 4 % of women . The severity of retinopathy was related in both sexes to higher fasting plasma glucose levels , higher systolic and diastolic blood pressure , lower serum insulin levels , and reduced beta-cell function . In addition , in men , increased alcohol consumption was related to increased severity of retinopathy , while leaner women had more severe eye lesions . Visual acuity was normal in most patients , but in men there was a trend for those with more severe retinal lesions to have worse visual acuity . CONCLUSIONS Diabetic retinopathy
Output:
| DED is estimated to be present in more than a quarter of persons with type 2 diabetes and half of persons with type 1 diabetes underlining the importance of regular monitoring . |
MS213426 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objectives To investigate the potential of nevirapine 200 mg once-daily regimen and evaluate the influence of patient characteristics on nevirapine concentrations . Methods This was a prospect i ve , multicentre cohort study with 532 HIV-infected patients receiving nevirapine as a part of their initial antiretroviral therapy . Plasma sample s were collected at trough or peak time at the end of week 2 ( lead-in period ) and week 4 , 12 , 24 , 36 , and 48 ( steady-state period ) , and nevirapine concentrations were determined using a vali date d HPLC method . Potential influencing factors associated with nevirapine concentrations were evaluated using univariate and multivariate logistic regression . Results A total of 2348 nevirapine plasma concentrations were collected , including 1510 trough and 838 peak values . The median nevirapine trough and peak concentration during the lead-in period were 4.26 µg/mL ( IQR 3.05–5.61 ) and 5.07 µg/mL ( IQR 3.92–6.44 ) respectively , which both exceeded the recommended thresholds of nevirapine plasma concentrations . Baseline hepatic function had a moderate effect on median nevirapine trough concentrations at week 2 ( 4.25 µg/mL v.s. 4.86 µg/mL , for ALT < 1.5 × ULN and ≥1.5 × ULN , respectively , P = 0.045 ) . No significant difference was observed in median nevirapine trough concentration between lead-in and steady-state periods in patients with baseline ALT and AST level ≥1.5 × ULN ( P = 0.171 , P = 0.769 ) , which was different from the patients with ALT/AST level < 1.5ULN . The median trough concentrations were significantly higher in HIV/HCV co-infected patients than those without HCV at week 48 ( 8.16 µg/mL v.s. 6.15 µg/mL , P = 0.004 ) . Conclusions The 200 mg once-daily regimen of nevirapine might be comparable to twice-daily in plasma pharmacokinetics in Chinese population . Hepatic function prior to nevirapine treatment and HIV/HCV coinfection were significantly associated with nevirapine concentrations . Registration Clinical trial.gov ID : Purpose Sexually transmitted infections ( STIs ) occur frequently in risk population s. Hereby , the role of screening-programmes remains controversial . Our study aim ed to determine the prevalence of STI infections in HIV-positive men-who-have-sex-with-men ( MSM ) . Methods We enrolled asymptomatic , HIV-MSM in a prospect i ve cross-sectional study from February to August 2016 at seven German HIV-centres . All subjects were screened for Treponema-pallidum ( TP ) and hepatitis-B/C-infection . HIV RNA and screening for oral , rectal and urethral colonisation by Chlamydia-trachomatis ( CT ) and /or Neisseria-gonorrhoeae ( NG ) was performed . All subjects were asked to complete a sexual-risk-behaviour- question naire . Results In total , 296 subjects with a median age of 43.2 ( 36.2–49.5 ) years were enrolled ; 99.3 % were on ART for 5.5 ( 2.3–11.2 ) years . HIV RNA was < 50 copies/mL in 93.6 % . Active syphilis infection was found in 5.0 % of all patients , whereas 55.4 % had history of infection . HCV seropositivity was found in 33 patients ( 13.2 % ) and positive HCV RNA was available in 39.4 % . 66/294 ( 22.5 % ) showed negative anti-HBs-antibodies , indicating lack of immunity . Overall , 40/296 ( 13.5 % ) had positive CT/NG swabs ( CT in 8.8 % ; 7.3 % anorectal , 1.7 % oropharyngeal , 1.0 % urethral and NG in 6.8 % ; 4.5 % anal , 2.0 % oropharyngeal , 1.4 % urethral ) . Time since HIV infection < 7 years ( OR 2.6 ( 1.2–5.5 ) ; p = 0.012 ) , the use of inhalative nitrites ( “ poppers ” ) ( OR 2.8 ( 1.3–5.9 ; p = 0.008 ) and reporting unprotected intercourse with > 20 partners within the last 6 months [ OR 3.0 ( 1.2–7.8 ) ; p = 0.003 ] were significantly associated in multivariate analysis . Conclusion We found high numbers of asymptomatic syphilis , hepatitis-C and CT/NG infections in HIV-MSM , remarkably in patients with shorter duration of HIV-infection with more sexual partners within last 6 months OBJECTIVES This study was design ed to assess the prevalence of HBV and HCV infection in HIV patients and evaluate the risk of infection compared with HIV negative control subjects . METHOD This is a prospect i ve case control study in which 240 HIV/AIDS patients and age and sex matched controls were evaluated . The diagnosis of HIV infection was based on a positive HIV screening test using Capillus test kits ( Trinity Biotech PLC , Irel and ) and confirmed using Western blot assay . HBsAg and anti-HCV were assayed by commercially available chromatographic immunoassay ( SD BIOLINE ) . RESULTS Eleven ( 9.2 % ) of the 120 HIV/AIDS patients and 8 ( 7 % ) of the 120 control subjects were positive for the HBsAg ( OR=1 , p=0.27 ) . HBeAg was detected in 3 of the 11 ( 27.3 % ) subjects with HIV/HBV co infections . HIV positive patients were 7 times more likely to have HCV infection than control patients ( 5.8 % compared with 0.8 % , OR=7.3 , p= 0.03 ) . CONCLUSION The lack of a strong association between HBV and HIV infection may be related to different exposure routes in this population where HBV infection is highly endemic and childhood infection almost universal . In this African population , HIV infection may be a super-infection of HBV infections contracted in childhood . This high HCV/HIV co-infection rate is consistent with the shared parenteral and sexual routes of transmission The purpose of this study is to determine the rate of human immunodeficiency virus ( HIV ) and hepatitis B surface antigen ( HBsAg ) among commercial blood donors in the University of Benin Teaching Hospital . Five thous and seven hundred and thirty-seven prospect i ve commercial blood donors were screened for both HIV and HBsAg . Three hundred and eighty-three ( 7 % ) donors were positive for HIV while 609 donors ( 11 % ) were positive for HBsAg . Thirty-seven donors were positive for both HIV and HBsAg . The need to make the screening of blood donors for HIV and HBsAg compulsory in all hospitals is crucial so that the spread of HIV and HBsAg can be prevented BACKGROUND An increasing proportion of deaths among human immunodeficiency virus (HIV)-infected persons with access to combination antiretroviral therapy ( cART ) are due to complications of liver diseases . METHODS We investigated the frequency of and risk factors associated with liver-related deaths in the Data Collection on Adverse Events of Anti-HIV Drugs study , which prospect ively evaluated 76 893 person-years of follow-up in 23 441 HIV-infected persons . Multivariable Poisson regression analyses identified factors associated with liver-related , AIDS-related , and other causes of death . RESULTS There were 1246 deaths ( 5.3 % ; 1.6 per 100 person-years ) ; 14.5 % were from liver-related causes . Of these , 16.9 % had active hepatitis B virus ( HBV ) , 66.1 % had hepatitis C virus ( HCV ) , and 7.1 % had dual viral hepatitis co-infections . Predictors of liver-related deaths were latest CD4 cell count ( adjusted relative rate [ RR ] , 16.1 ; 95 % confidence interval [ CI ] , 8.1 - 31.7 for < 50 vs > or = 500/microL ) , age ( RR , 1.3 ; 95 % CI , 1.2 - 1.4 per 5 years older ) , intravenous drug use ( RR , 2.0 ; 95 % CI , 1.2 - 3.4 ) , HCV infection ( RR , 6.7 ; 95 % CI , 4.0 - 11.2 ) , and active HBV infection ( RR , 3.7 ; 95 % CI , 2.4 - 5.9 ) . Univariable analyses showed no relationship between cumulative years patients were receiving cART and liver-related death ( RR , 1.00 ; 95 % CI , 0.93 - 1.07 ) . Adjustment for the most recent CD4 cell count and patient characteristics result ed in an increased risk of liver-related mortality per year of mono or dual antiretroviral therapy before cART ( RR , 1.09 ; 95 % CI , 1.02 - 1.16 ; P = .008 ) and per year of cART ( RR , 1.11 ; 95 % CI , 1.02 - 1.21 ; P = .02 ) . CONCLUSIONS Liver-related death was the most frequent cause of non-AIDS-related death . We found a strong association between immunodeficiency and risk of liver-related death . Longer follow-up is required to investigate whether clinical ly significant treatment-associated liver-related mortality will develop ABSTRACT Outbreaks of sexually transmitted hepatitis C virus ( HCV ) infections have been recently reported in HIV-infected men who have sex with men ( MSM ) in Europe , Australia , and North America . Little is known concerning whether this also occurs in other Asia-Pacific countries . Between 1994 and 2010 , a prospect i ve observational cohort study was performed to assess the incidence of recent HCV seroconversion in 892 HIV-infected patients ( 731 MSM and 161 heterosexuals ) who were not injecting drug users . A nested case-control study was conducted to identify associated factors with recent HCV seroconversion , and phylogenetic analysis was performed using NS5B sequences amplified from seroconverters . During a total followup duration of 4,270 person-years ( PY ) , 30 patients ( 3.36 % ) had HCV seroconversion , with an overall incidence rate of 7.03 per 1,000 PY . The rate increased from 0 in 1994 to 2000 and 2.29 in 2001 to 2005 to 10.13 per 1,000 PY in 2006 to 2010 ( P < 0.05 ) . After adjustment for age and HIV transmission route , recent syphilis remained an independent factor associated with HCV seroconversion ( odds ratio , 7.731 ; 95 % confidence interval , 3.131 to 19.086 ; P < 0.01 ) . In a nested case-control study , seroconverters had higher aminotranferase levels and were more likely to have CD4 ≥ 200 cells/μl and recent syphilis than nonseroconverters ( P < 0.05 ) . Among the 21 patients with HCV viremia , phylogenetic analysis revealed 7 HCV transmission clusters or pairs ( 4 within genotype 1b , 2 within genotype 2a , and 1 within genotype 3a ) . The incidence of HCV seroconversion that is associated with recent syphilis is increasing among HIV-infected patients in Taiwan Objectives Men who have sex with men ( MSM ) are at higher risk for coinfection with hepatitis B virus ( HBV ) , hepatitis C virus ( HCV ) , and syphilis than the general population . HIV infection and these coinfections accelerate disease progression reciprocally . This study evaluated the prevalence and incidence of these coinfections in HIV1-positive MSM in Germany . Material s and Methods As part of a nationwide , multicenter , prospect i ve cohort study of HIV-infected MSM , plasma sample s collected yearly were screened for HBsAg and antibodies to HBc , HBs , HCV , and syphilis . Sample s with indications of active HBV or HCV infection were confirmed by polymerase chain reaction . Prevalence and incidence of each infection and incidence rates per study participant were calculated , and incidences over 4-year time intervals compared . Results This study screened 5,445 sample s from 1,843 MSM . Median age at HIV seroconversion was 33 years . Prevalences of active , cleared , and occult HBV , and of active/cleared HCV were 1.7 % , 27.1 % , 0.2 % , and 8.2 % , respectively , and 4
Output:
| The global scale-up of HIV treatment for PLHIV using a tenofovir-based ART regimen provides an opportunity to simultaneously treat those with HBsAg co-infection and reduce mother-to-child transmission of HBV alongside HIV |
MS213427 | ***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: Hepatitis C is the most common indication for liver transplantation ( LT ) in the United States . Recurrence of hepatitis C virus ( HCV ) infection post-LT remains a problem for which there is no completely satisfactory treatment . The aim of the present study is to evaluate mycophenolate mofetil ( MMF ) , which has both immunosuppressive and antiviral properties , to determine whether it is associated with a difference in the rate of HCV recurrence and also examine its impact on patient and graft survival . Between August 1995 and May 1998 , a total of 106 patients who were HCV positive before LT were r and omized to tacrolimus ( TAC ) and prednisone versus TAC , prednisone , and MMF therapy . The rate of recurrence of HCV , patient and graft survival , incidences of rejection , and histological findings were examined . Fifty six patients were r and omized to TAC and steroid therapy ( double [ D ] drug ; group D ) , and 50 patients were r and omized to TAC , steroid , and MMF therapy ( triple [ T ] drug ; group T ) . Liver biopsies were performed when liver function was abnormal ; protocol liver biopsies were not performed . Mean follow-up was 4.3 + /- 0.8 years . Actuarial patient survivals at 4 years were 72.6 % in group D and 73.8 % in group T ( P = not significant ) . Actuarial graft survivals at 4 years were 65.6 % in group D and 65.4 % in group T. One patient in group D and 2 patients in group T underwent a second LT for recurrent HCV . One patient in each group died of recurrent HCV without re-LT . Twenty-six patients in group D ( 46.4 % ) and 23 patients in group T ( 46.0 % ) showed signs of recurrent HCV . Mean hepatitis activity index ( HAI ) scores were 7.4 + /- 2.7 in group D and 7.0 + /- 3.4 in group T , and mean fibrosis scores were 2.9 + /- 1.7 in group D and 2.6 + /- 1.1 in group T. The rate of rejection was 0.57/patient in each group for the entire follow-up period . None of these values reached statistical significance . Rates of HCV recurrence , graft loss or death from recurrent HCV , and 4-year actuarial patient and graft survival were not different between the groups . In liver transplant recipients with HCV , MMF has no impact on patient survival , graft survival , rejection , or rate of HCV recurrence based on biochemical changes and histological findings . In addition , there was no difference in HAI or fibrosis score between the two groups . Either MMF has no anti-HCV effect or its immunosuppressive properties overwhelm its antiviral effect in the clinical setting C IRRHOSIS caused by hepatitis C virus ( HCV ) accounts for at least 30 % of all liver transplants ( OLT ) currently performed in adults . ’ Good survival of patients with such an indication has been described , even though the reappearance of viral genome ( HCV-RNA ) occurs in more than 90 % of patients during the first year after transplantation . ‘ . ’ The course of recurrent HCV graft infection is generally benign . Nevertheless , some concerns about the long-term outcome of the disease have arisen since at least 50 % of HCV-RNA positive patients develop chronic hepatitis within two years’,2 and 35 % of livers are seriuosly injured ( chronic active hepatitis and cirrhosis ) 5 years after transplantation.4 In the present study , a therapeutic attempt to prevent recurrent HCV infection was undertaken in a group of HCV-RNA positive transplant recipients , using a combination of interferon and ribavirin early after OLT . The preliminary results of this pilot experience , the first of its kind , are reported herein OBJECTIVES To analyze sources search ed in Cochrane review s , to determine the proportion of trials included in review s that are indexed in major data bases , and to compare the quality of these trials with those from other sources . METHODS All new systematic review s in the Cochrane Library , Issue1 2001 , that were restricted to r and omized controlled trials ( RCTs ) or quasi- RCTs were selected . The sources search ed in the review s were recorded , and the trials included were checked to see whether they were indexed in four major data bases . Trials not indexed were checked to determine how they could be identified . The quality of trials found in major data bases was compared with those found from other sources . RESULTS The range in the number of data bases search ed per review ranged between one and twenty-seven . The proportion of the trials in the four data bases were Cochrane Controlled Trials Register = 78.5 % , MEDLINE = 68.8 % , Embase = 65.0 % , and Science/Social Sciences Citation Index = 60.7 % . Search ing another twenty-six data bases after Cochrane Controlled Trials Register ( CCTR ) , MEDLINE , and Embase only found 2.4 % additional trials . There was no significant difference between trials found in the CCTR , MEDLINE , and Embase compared with other trials , with respect to adequate allocation concealment or sample size . CONCLUSIONS There was a large variation between review s in the exhaustiveness of the literature search es . CCTR was the single best source of RCTs . Additional data base search ing retrieved only a small percentage of extra trials . Contacting authors and manufacturers to find unpublished trials appeared to be a more effective method of obtaining the additional better quality trials The aim of the study was to observe the frequency of neutropenia during Pegylated Interferon/Ribavirin therapy in patient with chronic hepatitis C ; to compare the efficacy of two strategies of management of neutropenia -- with Interferon dose modification and with Neupogen administration ; to compare the effectiveness rate of sustained viral response ( SVR ) in patients with Pegylated Interferon dose modification and in patients treated by using granulocyte colony-stimulating factor G-CSF-filgrastim . ( Neupogen ) . Study enrolled 47 patients with chronic active hepatitis C , aged 23 - 64 . ( 38 male and 9 female ) . All patients had HCV genotype 1b . Significant neurtopenia ( ANC<750 mm3 ) and severe neurtopenia ( ANC<500 mm3 ) developed in 41 of 47 patients ( 87 % ) . 41 patients with neurtopenia were r and omized into two groups . The first group--22 patients who received granulocyte colony-stimulating factor ( G-CSF , or filgrastim ) 300 mcg s/c weekly for correction of neutropenia and the second group--19 patients treated either with Interferon dose reduction or temporarily inhibit of Interferon treatment . In all 22 patients of the first group neutropenia was normalized without reduction and /or inhibit of Pegylated interferon . Neupogen was well tolerated and in all 22 patients the improvement of quality of life ( QOL ) was observed . It was concluded that dose reduction or temporary inhibit of Pegylated Interferon in the second group negatively acts on antiviral treatment response in patients with HCV genotype 1 . In patients with PEG-IFN/RBV therapy Neupogen effectively manages neutropenia and gives opportunity to maintain interferon dose ( without reduction ) . Neupogen has the potential to improve adherence rates , which may in turn improve SVR Ischemic preconditioning ( IPC ) has the potential to decrease graft injury and morbidity after liver transplantation . We prospect ively investigated the safety and efficacy of 5 minutes of IPC induced by hilar clamping in local deceased donor livers r and omized 1:1 to st and ard ( STD ) recovery ( N = 28 ) or IPC ( N = 34 ) . Safety was assessed by measurement of heart rate , blood pressure , and visual inspection of abdominal organs during recovery , and efficacy by recipient aminotransferases ( aspartate aminotransferase [ AST ] and alanine aminotransferase [ ALT ] , both measured in U/L ) , total bilirubin , and international normalized ratio of prothrombin time ( INR ) after transplantation . IPC performed soon after laparotomy did not cause hemodynamic instability or visceral congestion . Recipient median AST , median ALT , and mean INR , in STD vs. IPC were as follows : day 1 AST 696 vs. 841 U/L ; day 3 AST 183 vs. 183 U/L ; day 1 ALT 444 vs. 764 U/L ; day 3 ALT 421 vs. 463 U/L ; day 1 INR 1.7 + /- .4 vs. 2.0 + /- .8 ; and day 3 INR 1.3 + /- .2 vs. 1.4 + /- .3 ; all P > .05 . No instances of nonfunction occurred . The 6-month graft and patient survival STD vs. IPC were 82 vs. 91 % and median hospital stay was 10 vs. 8 days ; both P > .05 . In conclusion , deceased donor livers tolerated 5 minutes of hilar clamping well , but IPC did not decrease graft injury . Further trials with longer periods of preconditioning such as 10 minutes are needed A r and omized , double-blind , dose-escalation study evaluated the safety and efficacy of hepatitis C virus (HCV)-Ab(XTL)68 , a neutralizing , high-affinity , fully human , anti-E2 monoclonal antibody , in 24 HCV-positive patients undergoing liver transplantation . HCV-Ab(XTL)68 or placebo was administered at doses from 20 - 240 mg as 2 - 4 infusions during the first 24 hours after transplantation , followed by daily infusions for 6 days , weekly infusions for 3 weeks , and either 2 or 4 weekly infusions for 8 weeks . Serum concentrations of total anti-E2 obtained during daily infusions of 120 - 240 mg HCV-Ab(XTL)68 were 50 - 200 microg/mL above concentrations in the placebo group . Median serum concentration of HCV RNA dropped below baseline in all groups immediately after transplantation . On day 2 , median change from baseline in HCV RNA was -1.8 and -2.4 log in the 120-mg and 240-mg groups , respectively , compared with -1.5 log with placebo . The difference was lost after day 7 when the dosing frequency was reduced . The coincidence of increases in anti-E2 with decreases in HCV RNA concentration indicate that the dose-related changes in HCV RNA concentration were a result of HCV-Ab(XTL)68 administration in the 120- and 240-mg groups . The overall incidence of nonfatal serious adverse events was higher with placebo ( 60 % ) vs. all active treatments combined ( 42 % ) . In conclusion , HCV-Ab(XTL)68 may decrease serum concentrations of HCV RNA in patients after liver transplantation . Studies evaluating more frequent daily dosing at doses > 120 mg are necessary to investigate sustained viral suppression in this population The effect of ischemic preconditioning ( IPC ) in orthotopic liver transplantation ( OLT ) has not yet been clarified . We performed a pilot study to evaluate the effects of IPC in OLT by comparing the outcomes of recipients of grafts from deceased donors r and omly assigned to receive ( IPC+ group , n = 23 ) or not ( IPC- group , n = 24 ) IPC ( 10-min ischemia + 15-min reperfusion ) . In 10 cases in the IPC+ group and in 12 in the IPC- group , the expression of inducible nitric oxide synthase ( iNOS ) , neutrophil infiltration , and hepatocellular apoptosis were tested by immunohistochemistry in prereperfusion and postreperfusion biopsies . Median aspartate aminotransferase ( AST ) levels were lower in the IPC+ group vs. the IPC- group on postoperative days 1 and 2 ( 398 vs. 1,234 U/L , P = 0.002 ; and 283 vs. 685 U/L , P = 0.009 ) . Alanine aminotransferases were lower in the IPC+ vs. the IPC- group on postoperative days 1 , 2 , and 3 ( 333 vs. 934 U/L , P = 0.016 ; 492 vs. 1,040 U/L , P = 0.008 ; and 386 vs. 735 U/L , P = 0.022 ) . Bilirubin levels and prothrombin activity throughout the first 3 postoperative weeks , incidence of graft nonfunction and graft and patient survival rates were similar between groups . Prereperfusion and postreperfusion immunohistochemical parameters did not differ between groups . iNOS was higher postreperfusion vs. prereperfusion in the IPC- group ( P = 0.008 ) . Neutrophil infiltration was higher postreperfusion vs. prereperfusion in both groups ( IPC+ , P = 0.007 ; IPC- , P = 0.003 ) . Prereperfusion and postreperfusion apoptosis was minimal in both groups . In conclusion , IPC reduced ischemia/reperfusion injury through a decrease of hepatocellular ne
Output:
| There was no significant differences in the patient survival , graft rejection , re-transplantation , or HCV recurrence between intervention and control groups in any of the comparisons that reported these outcomes .
Life-threatening adverse events were not reported in either group in any of the comparisons .
There is currently no evidence to recommend prophylactic antiviral treatment to prevent recurrence of HCV infection either in primary liver transplantation or re-transplantation . |
MS213428 | ***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 strategy remains unclear with no clear consensus for men with high-risk prostate cancer ( PCa ) after radical prostatectomy . We aim ed to evaluate into a prospect i ve r and omized trial the effectiveness and feasibility of adjuvant weekly paclitaxel combined with and rogen deprivation therapy ( ADT ) in these patients . A total of 47 patients with high-risk PCa were r and omized 6 weeks after radical prostatectomy : ADT alone versus combination of ADT and weekly paclitaxel . Toxicity , quality -of-life and functional results were compared between the two arms . All 23 patients completed eight cycles of paclitaxel . Toxicity was predominantly of grade 1–2 severity . There were no differences in EORTC QLQ-C30 scores between the two groups and between baseline and last assessment at 24 months after surgery . Urinary continence was complete at 1 year after surgery for all patients and no significant differences were noted at each assessment between the two groups . The interim analysis of this trial confirms the feasibility of weekly paclitaxel in combination with ADT in men at high-risk PCa with curative intent . This adjuvant combined therapy does not alter quality -of-life and continence recovery after surgery plus ADT . A larger cohort is awaited to determine the oncological outcomes of this strategy Treatment of high‐risk localized prostate cancer remains inadequate . The authors performed a phase 2 multicenter trial of neoadjuvant docetaxel plus bevacizumab before radical prostatectomy Background The optimal management of high-risk prostate cancer remains uncertain . In this study we assessed the safety and efficacy of a novel multimodal treatment paradigm for high-risk prostate cancer . Methods This was a prospect i ve phase II trial including 35 patients with newly diagnosed high-risk localized or locally advanced prostate cancer treated with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy , concurrent intensified-dose docetaxel-based chemotherapy and long-term and rogen deprivation therapy . Primary endpoint was acute and late toxicity evaluated with the Common Terminology Criteria for Adverse Events version 3.0 . Secondary endpoint was biochemical and clinical recurrence-free survival explored with the Kaplan-Meier method . Results Acute gastro-intestinal and genito-urinary toxicity was grade 2 in 23 % and 20 % of patients , and grade 3 in 9 % and 3 % of patients , respectively . Acute blood/bone marrow toxicity was grade 2 in 20 % of patients . No acute grade ≥4 toxicity was observed . Late gastro-intestinal and genito-urinary toxicity was grade 2 in 9 % of patients each . No late grade ≥3 toxicity was observed . Median follow-up was 63 months ( interquartile range 31–79 ) . Actuarial 5-year biochemical and clinical recurrence-free survival rate was 55 % ( 95 % confidence interval , 35 - 75 % ) and 70 % ( 95 % confidence interval , 52 - 88 % ) , respectively . Conclusions In our phase II trial testing a novel multimodal treatment paradigm for high-risk prostate cancer , toxicity was acceptably low and mid-term oncological outcome was good . This treatment paradigm , thus , may warrant further evaluation in phase III r and omized trials PURPOSE Trial RTOG 9202 was a phase 3 r and omized trial design ed to determine the optimal duration of and rogen deprivation therapy ( ADT ) when combined with definitive radiation therapy ( RT ) in the treatment of locally advanced nonmetastatic adenocarcinoma of the prostate . Long-term follow-up results of this study now available are relevant to the management of this disease . METHODS AND MATERIAL S Men ( N=1554 ) with adenocarcinoma of the prostate ( cT2c-T4 , N0-Nx ) with a prostate-specific antigen ( PSA ) < 150 ng/mL and no evidence of distant metastasis were r and omized ( June 1992 to April 1995 ) to short-term ADT ( STAD : 4 months of flutamide 250 mg 3 times per day and goserelin 3.6 mg per month ) and definitive RT versus long-term ADT ( LTAD : STAD with definitive RT plus an additional 24 months of monthly goserelin ) . RESULTS Among 1520 protocol -eligible and evaluable patients , the median follow-up time for this analysis was 19.6 years . In analysis adjusted for prognostic covariates , LTAD improved disease-free survival ( 29 % relative reduction in failure rate , P<.0001 ) , local progression ( 46 % relative reduction , P=.02 ) , distant metastases ( 36 % relative reduction , P<.0001 ) , disease-specific survival ( 30 % relative reduction , P=.003 ) , and overall survival ( 12 % relative reduction , P=.03 ) . Other-cause mortality ( non-prostate cancer ) did not differ ( 5 % relative reduction , P=.48 ) . CONCLUSIONS LTAD and RT is superior to STAD and RT for the treatment of locally advanced nonmetastatic adenocarcinoma of the prostate and should be considered the st and ard of care Purpose Systemic Therapy for Advanced or Metastatic Prostate Cancer : Evaluation of Drug Efficacy is a r and omized controlled trial using a multiarm , multistage , platform design . It recruits men with high-risk , locally advanced or metastatic prostate cancer who were initiating long-term hormone therapy . We report survival data for two celecoxib (Cel)-containing comparisons , which stopped accrual early at interim analysis on the basis of failure-free survival . Patients and Methods St and ard of care ( SOC ) was hormone therapy continuously ( metastatic ) or for ≥ 2 years ( nonmetastatic ) ; prostate ( ± pelvic node ) radiotherapy was encouraged for men without metastases . Cel 400 mg was administered twice a day for 1 year . Zoledronic acid ( ZA ) 4 mg was administered for six 3-weekly cycles , then 4-weekly for 2 years . Stratified r and om assignment allocated patients 2:1:1 to SOC ( control ) , SOC + Cel , or SOC + ZA + Cel . The primary outcome measure was all-cause mortality . Results were analyzed with Cox proportional hazards and flexible parametric models adjusted for stratification factors . Results A total of 1,245 men were r and omly assigned ( Oct 2005 to April 2011 ) . Groups were balanced : median age , 65 years ; 61 % metastatic , 14 % N+/X M0 , 25 % N0M0 ; 94 % newly diagnosed ; median prostate-specific antigen , 66 ng/mL. Median follow-up was 69 months . Grade 3 to 5 adverse events were seen in 36 % SOC-only , 33 % SOC + Cel , and 32 % SOC + ZA + Cel patients . There were 303 control arm deaths ( 83 % prostate cancer ) , and median survival was 66 months . Compared with SOC , the adjusted hazard ratio was 0.98 ( 95 % CI , 0.80 to 1.20 ; P = .847 ; median survival , 70 months ) for SOC + Cel and 0.86 ( 95 % CI , 0.70 to 1.05 ; P = .130 ; median survival , 76 months ) for SOC + ZA + Cel . Preplanned subgroup analyses in men with metastatic disease showed a hazard ratio of 0.78 ( 95 % CI , 0.62 to 0.98 ; P = .033 ) for SOC + ZA + Cel . Conclusion These data show no overall evidence of improved survival with Cel . Preplanned subgroup analyses provide hypotheses for future studies Study Type – Therapy ( phase 1 BACKGROUND This was a phase I study to find the maximum tolerable dose ( MTD ) of weekly docetaxel combined with high-dose intensity-modulated radiotherapy ( IMRT ) and and rogen deprivation therapy ( ADT ) . PATIENTS AND METHODS Men with localized high-risk prostate cancer ( HRPC ) were treated with weekly docetaxel at 10 to 30 mg/m(2 ) concurrent with IMRT of 77.4 Gy to the prostate and 45 Gy to the seminal vesicles . ADT consisted of a gonadotropin-releasing hormone agonist ( GnRHa ) and bicalutamide beginning 2 months before and during chemoradiation . GnRHa was continued for 24 months . RESULTS Nineteen patients were enrolled . No dose-limiting toxicity ( DLT ) was seen with docetaxel doses up to 25 mg/m(2 ) . At the 30 mg/m(2 ) level , 2 of 4 patients experienced DLTs of both grade 3 fatigue and dyspepsia . At 41 months ' median follow-up , 2 patients had died--1 from metastatic prostate cancer and the other from heart failure . Two other patients experienced biochemical failure . One patient with bladder invasion at diagnosis experienced late grade 2 urinary hesitancy 9 months after completion of radiotherapy , requiring short-term intermittent catheterization . All patients had erectile dysfunction , but no late toxicities worse than grade 2 were identified . CONCLUSION Weekly docetaxel may be combined with high-dose IMRT and long-term ADT up to a MTD of 25 mg/m(2 ) . Acute toxicities and long-term side effects of this regimen were acceptable . Future studies evaluating the efficacy of docetaxel , ADT , and IMRT for localized HRPC should use a weekly dose of 25 mg/m(2 ) when limiting the irradiated volume to the prostate and seminal vesicles BACKGROUND Prostate cancer ( PC ) is the most commonly diagnosed noncutaneous malignancy in American men . PC , which exhibits a slow growth rate and multiple potential target epitopes , is an ideal c and i date for immunotherapy . GVAX for prostate cancer is a cellular immunotherapy , composed of PC-3 cells ( CG1940 ) and LNCaP cells ( CG8711 ) . Each of the components is a prostate adenocarcinoma cell line that has been genetically modified to secrete granulocyte-macrophage colony-stimulating factor . Hypothesizing that GVAX for prostate cancer could be effective in a neoadjuvant setting in patients with locally advanced disease , we initiated a phase II trial of neoadjuvant docetaxel and GVAX . For the trial , the clinical effects of GVAX were assessed in patients undergoing radical prostatectomy ( RP ) . METHODS Patients received docetaxel administered at a dose of 75 mg/m(2 ) every 3 weeks for 4 cycles . GVAX was administered 2 - 3 days after chemotherapy preoperatively for four courses of immunotherapy . The first dose of GVAX was a prime immunotherapy of 5 × 10(8 ) cells . The subsequent boost immunotherapies consisted of 3 × 10(8 ) cells . After RP , patients received an additional six courses of immunotherapy . Pathologic complete response , toxicity , and clinical response were assessed . The primary endpoint of the trial was a pathologic state of pT0 , which is defined as no evidence of cancer in the prostate . RESULTS Six patients completed neoadjuvant docetaxel and GVAX therapy . No serious drug-related adverse events were observed . Median change in prostate-specific antigen ( PSA ) following neoadjuvant therapy was 1.47 ng/ml . One patient did not undergo RP due to the discovery of positive lymph nodes during exploration . Of the five patients completing RP , four had a downstaging of their Gleason score . Undetectable PSA was achieved in three patients at 2 months after RP and in two patients at 3 years after RP . CONCLUSIONS Neoadjuvant docetaxel/GVAX is safe and well tolerated in patients with high-risk locally advanced PC . No evidence of increased intraoperative hemorrhage or increased length of hospital stay postoperatively was noted . These results justify further study of neoadjuvant immunotherapy To determine long‐term oncological outcomes of radical prostatectomy ( RP ) after neoadjuvant chemohormonal therapy ( CHT ) for clinical ly localised , high‐risk prostate cancer PURPOSE To evaluate the efficacy and safety profile of vinorelbine and estramustine in combination with three-dimensional conformational radiotherapy ( 3D-CRT ) in patients with localized high-risk prostate cancer . METHODS AND MATERIAL S Fifty patients received estramustine , 600 mg/m(2 ) daily , and vinorelbine , 25 mg/m(2 ) , on days 1 and 8 of a 21-day cycle for three cycles in combination with 8 weeks of 3D-CRT ( total dose of 70.2 gray [ Gy ] at 1.8-Gy fractions or 70 Gy at 2.0-Gy fractions ) . Additionally , patients received luteinizing hormone-releasing hormone analogs for 3 years . RESULTS All patients were evaluated for response and toxicity . Progression-free survival at 5 years was 72 % ( 95 % confidence interval [ CI ] : 52 - 86 ) . All patients who relapsed had only biochemical re
Output:
| According to multiple r and omized trials , combining and rogen deprivation therapy ( ADT ) with external-beam radiotherapy ( EBRT ) outperforms EBRT alone for both relapse-free and overall survival .
Neoadjuvant ADT did not show significant improvement compared with prostatectomy alone .
GETUG 12 , RTOG 0521 , and nonmetastatic subgroup of the STAMPEDE trial showed improved relapse-free survival for docetaxel in patients treated with EBRT plus ADT , although mature metastasis-free survival data are still pending .
Both the SPCG-12 and the VACSP#553 trial showed no improvement in relapse-free survival for adjuvant docetaxel after prostatectomy .
In contrast to the clearly demonstrated survival benefits of long-term adjuvant ADT when used with EBRT , its role after prostatectomy remains unclear especially in pN0 patients .
Adding docetaxel to EBRT-ADT improves relapse-free survival , with immature results on overall survival . |
MS213429 | ***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 Alcohol-exposed pregnancies ( AEPs ) are a preventable cause of birth defects and developmental disabilities for which many women are at risk . The initial 5-session Project CHOICES intervention was found to prevent AEPs . In the ensuing decade , there have been several additional CHOICES-like studies . This study , Project Healthy CHOICES , had 2 objectives : ( i ) to compare outcomes for students versus nonstudents ; and ( ii ) to test a self-administered mail-based version of the Project CHOICES intervention . METHODS A r and omized controlled trial ( RCT ) compared 2 interventions for women of childbearing age ( 18 to 44 ) who were at risk of an AEP : ( i ) motivational feedback based on Project CHOICES and ( ii ) information only . Advertisements recruited 354 women ( 145 college students ; 209 nonstudents ) at risk of an AEP . Intervention and study material s were available in English and Spanish . Of the 354 women , 44 % were minorities ( 25 % identified as Hispanics ) . RESULTS At the 6-month follow-up , the interventions did not differ and there was no Intervention by Student Study interaction . However , over the entire 6-month follow-up , significantly more students ( 68 % ) than nonstudents ( 46 % ) were not at risk of an AEP ( 2.1 odds ratio ; confidence interval = 1.47 to 2.95 ) . For all groups , risk reduction occurred primarily through effective contraception . CONCLUSIONS There was no significant difference between the 2 interventions . However , over the entire 6-month follow-up interval , college students were significantly more likely than nonstudents to not be at risk of an AEP and to use effective contraception . While the student groups had significantly higher reduced risk of AEP outcomes , there was also substantial risk reduction for women in the information only condition . These results suggest that the most effective AEP prevention efforts would be to inform women at risk that they could become pregnant . Because about half of all pregnancies are unplanned , identifying women at risk and preventing the risk of AEPs should be a public health priority BACKGROUND Fetal alcohol spectrum disorders ( FASD ) comprise a continuum of lifelong outcomes in those born prenatally exposed to alcohol . Although studies have shown no differences in rates by race , FASD is of particular concern for American Indian communities . One tribally run prevention program is the Oglala Sioux Tribe ( OST ) CHOICES Program , which is modeled after the evidence -based CHOICES program that was focused on preconceptional prevention of alcohol-exposed pregnancy ( AEP ) by reducing risky drinking in women at risk for pregnancy and /or preventing unintended pregnancy . METHODS The OST CHOICES Program was made culturally appropriate for American Indian women and implemented with 3 communities , 2 on the reservation and 1 off . Data on drinking , sexual activity , and contraception use were collected at baseline and 3 and 6 months postintervention . Data were analyzed using descriptive statistics , 1-way analysis of variance , and a r and om intercept generalized estimating equation model . RESULTS A total of 193 nonpregnant American Indian women enrolled in the OST CHOICES Program , and all were at risk for AEP because of binge drinking and being at risk for an unintended pregnancy . Fifty-one percent of participants completed both 3- and 6-month follow-ups . Models showed a significant decrease in AEP risk from baseline at both 3- and 6-month follow-ups , indicating the significant impact of the OST CHOICES intervention . Women in the OST CHOICES Program were more likely to reduce their risk for AEP by utilizing contraception , rather than decreasing binge drinking . CONCLUSIONS Even with minor changes to make the CHOICES intervention culturally and linguistically appropriate and the potential threats to program validity those changes entail , we found a significant impact in reducing AEP risk . This highlights the capacity for the CHOICES intervention to be implemented in a wide variety of setting s and population ABSTRACT Background : Postpartum contraception is especially important for women who use alcohol and other substances , given the risk of possible rapid repeat pregnancy and prenatal substance exposure . However , little is known about postpartum contraceptive use among women with substance use histories . Objective : To characterize postpartum contraceptive initiation , 24-month continuation , and rapid repeat pregnancy among women who used substances during pregnancy . Methods : This is a secondary analysis of 161 pregnant women who enrolled in a r and omized clinical trial to treat substance use in pregnancy and completed at least one follow-up assessment . Women were eligible if they were less than 28 weeks gestation and reported alcohol or illicit drug use within the past 30 days . Participants were recruited from two hospital-based OB/GYN clinics between 2006 and 2010 , and completed assessment s at delivery and 3- , 12- , and 24-months postpartum . Results : Past 30-day use of any substance ( not including tobacco ) was 52.4 % , 58.3 % , and 59.8 % at 3- , 12- , and 24-month follow-up , respectively . Marijuana was the most commonly reported illicit substance ( as high as 48.1 % ) . Rates of any contraceptive use were 71.3 % , 66.7 % and 65.3 % at 3- , 12- , and 24-month follow-up , respectively ; DepoProvera and condoms were the most common methods . Rapid repeat pregnancy occurred in 28 % of participants by 24-month follow-up . Conclusions / Importance : Postpartum contraceptive use among substance using women was at or near 70 % , which is comparable to other sample s of postpartum women . Innovative efforts are needed to promote effective contraceptive use among postpartum women in general and among those who use substances in particular BACKGROUND The study was conducted to determine whether perceived racial , economic and gender discrimination has an impact on contraception use and choice of method . METHODS We analyzed the first 2,500 women aged 14 - 45 years enrolled in the Contraceptive CHOICE Project , a prospect i ve cohort study aim ed to reduce barriers to obtaining long-acting reversible contraception . Items from the " Experiences of Discrimination " ( EOD ) scale measured experienced race- , gender- and economic-based discrimination . RESULTS Overall , 57 % of women reported a history of discrimination . Thirty-three percent reported gender- or race-based discrimination , and 24 % reported discrimination attributed to socioeconomic status ( SES ) . Prior to study enrollment , women reporting discrimination were more likely to report any contraception use ( 61 % vs. 52 % , p<.001 ) but were more likely to use less effective methods ( e.g. , barrier methods , natural family planning or withdrawal ; 41 % vs. 32 % , p<.001 ) . In adjusted analyses , gender- , race- or SES-based discrimination were associated with increased current use of less effective methods [ adjusted risk ratio ( aRR ) 1.22 , 95 % confidence interval ( CI ) 1.06 - 1.41 ; aRR 1.25 , CI 1.08 - 1.45 ; aRR 1.23 , CI 1.06 - 1.43 , respectively ] . After enrollment , 66 % of women with a history of experience of discrimination chose a long-acting reversible contraceptive method ( intrauterine device or implantable ) and 35 % chose a depo-medroxyprogesterone acetate or contraceptive pill , patch or ring . CONCLUSIONS Discrimination negatively impacts a woman 's use of contraception . However , after financial and structural barriers to contraceptive use were eliminated , women with EOD overwhelmingly selected effective methods of contraception . Future interventions to improve access and utilization of contraception should focus on eliminating barriers and targeting interventions that encompass race- , gender- and economic-based discrimination Objective To document the contraceptive choices and continuation rates for different contraceptives in a group of pregnant women who use opiates . Methods A prospect i ve study set in a large city in the north of Engl and that looked at 40 pregnant women who used opiates in the index pregnancy . The study involved review ing the records from the patients ' general practitioners with information on the continuation rates of the chosen method of contraception and any related problems . Results The women given Depo-Provera ® ( n = 14 ) did not continue the method after the first injection . Those given implants ( n = 20 ) had a 95 % continuation rate at a mean follow-up of over 11 months . Conclusions Implants had a good continuation rate when used for postnatal contraception in women who used opiates in pregnancy . Depo-Provera may not be a suitable choice since all the women who chose this contraceptive method failed to continue with it Home visitation interventions show promise for helping at-risk mothers , yet few programs have been developed and evaluated specifically for alcohol and drug-abusing pregnant women . This study examines outcomes among 216 women enrolled in the Washington State Parent-Child Assistance Program , a three-year intervention program for women who abuse alcohol and drugs during an index pregnancy . Pretest-posttest comparison was made across three sites : the original demonstration ( 1991–1995 ) , and the Seattle and Tacoma replications ( 1996–2003 ) . In the original demonstration , the client group performed significantly better than controls . Compared to the original demonstration , outcomes at replication sites were maintained ( for regular use of contraception and use of reliable method ; and number of subsequent deliveries ) , or improved ( for alcohol/drug treatment completed ; alcohol/drug abstinence ; subsequent delivery unexposed to alcohol/drugs ) . Improved outcomes at replication sites are not attributable to enrolling lower-risk women . Public policies and programs initiated over the study period may have had a positive effect on outcomes . Study findings suggest that this community-based intervention model is effective over time and across venues Many college women are at risk for pregnancy , and binge drinking college women are often at risk for alcohol-exposed pregnancy . Brief interventions with sustainable outcomes are needed , particularly for college women who are binge drinking , at risk for pregnancy , and at increased risk of alcohol-exposed pregnancy . Two-hundred-twenty-eight women at a Mid-Atlantic urban university at risk for alcohol-exposed pregnancy enrolled in the r and omized clinical trial , and 207 completed the 4 month follow-up . The BALANCE intervention used Motivational Interviewing plus feedback to target drinking and contraception behaviors . Main outcome measures included ( 1 ) the rate of risk for alcohol-exposed pregnancy , ( 2 ) the rate of risk drinking , and ( 3 ) the rate of pregnancy risk . At 4-month follow-up , the rate of alcohol-exposed pregnancy risk was significantly lower in the intervention ( 20.2 % ) than the control condition ( 34.9 % ) , ( P < .02 ) . Assignment to the intervention condition halved the odds of women remaining at risk for alcohol-exposed pregnancy , while not receiving the intervention doubled the odds of continued alcohol-exposed pregnancy risk ( OR = 2.18 ; 95 % CI = 1.16–4.09 ) . A baseline history of blackouts , continued high blood alcohol drinking days at 1 month , and continued risk for pregnancy at 1 month independently contributed to a multivariate model of continued alcohol-exposed pregnancy risk at 4 month follow-up . BALANCE reduced alcohol-exposed pregnancy risk , with similar outcomes to longer interventions . Because early response predicted sustained alcohol-exposed pregnancy risk reduction , those who fail to achieve initial change could be identified for further intervention . The BALANCE intervention could be adopted into existing student health or university alcohol programs . The risks of unintended pregnancy and alcohol-exposed pregnancy among binge drinking women in college merit greater prevention efforts A significant number of college women are at risk for alcohol-exposed pregnancy ( AEP ) owing to binge drinking paired with using contraception ineffectively . This article describes a r and omized controlled trial of a one-session motivational interviewing-based intervention to reduce AEP risk among college women and presents 1-month outcomes demonstrating the early impact of this intervention . There were 228 female students from a mid-Atlantic urban university enrolled in the trial . Eligibility criteria were being in the age range of 18 - 24 years and being at risk for AEP . Risk for AEP was defined as having sexual intercourse with a man in the past 90 days while using contraception ineffectively ( no use , incorrect use of an effective method , or use of an ineffective method only ) ; drinking at risky levels was defined as engaging in at least one binge in the past 90 days or consuming an average of eight st and ard drinks per week . One-month outcome data were available for 212 of the 228 enrolled women ( a follow-up rate of 93 % ) , with complete data available for 105 women assigned to the control condition and 94 assigned to the intervention condition . At 1-month follow-up , 15 % of the control subjects and 25 % of the intervention women reported no risk drinking , a significant difference favoring the intervention group . Significantly fewer control subjects ( 48 % ) used effective contraception at 1-month follow-up as compared with intervention women ( 64 % ) , chi(2)(1 ) = 5.1 , p < .03 . Significantly more intervention
Output:
| Interventions based on behavior change theory yielded an increase in the initiation of effective contraception as compared with provision of written information material s. The effect was more pronounced when the intervention provided on-site contraceptive counseling and free access to birth control .
Financial incentives also seemed to effectively increase women 's contraception intake .
Case management interventions including pregnant and postpartum women with heavy levels of substance use showed promising results in terms of initiation of contraception , but rates of unintended pregnancy over long-term follow-up were nevertheless elevated .
Finally , some interventions integrated family planning services into specialized centers taking care of pregnant and postpartum women with substance abuse .
All interventions with a primary or secondary focus on the prevention of unintended pregnancy in women using psychoactive substances short-term improvements in contraception intake , but it is unclear if these effects last or have any impact on unintended pregnancy rates in the long-term |
MS213430 | ***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: Noncompliance with medication and follow-up care was evaluated in 538 renal , 50 heart , and 13 liver transplant recipients . In a retrospective review of 260 kidney transplant recipients followed from three months posttransplant , the incidence of medication noncompliance was 18 % . It was 15 % in a prospect i ve study of 196 kidney recipients from 1984 to 1987 . Patients most likely to become noncompliant were young and in a lower socioeconomic group . There was no significant difference in the incidence of noncompliance with respect to cadaveric vs. living-related donor kidney source , or in male vs. female patients . There was a higher incidence of noncompliance in blacks and Hispanics , but that may have been due to a higher incidence of lower socioeconomic status in those groups . Noncompliance can occur many years posttransplant and was seen in heart and liver transplant recipients . In the retrospective study , 91 % of kidney transplant recipients who were noncompliant with medications and follow-up care either lost their grafts or died . Noncompliant behavior was usually not predictable and was often without an identifiable reason . Efforts to increase compliance , such as better patient selection , more education , and simplified medical regimens may have reduced the incidence of noncompliance in recent patients The objective of this r and omized controlled trial was to assess the effects of a 1‐year behavioral contract intervention on immunosuppressant therapy ( IST ) adherence and healthcare utilizations and costs among adult renal transplant recipients ( RTRs ) . The sample included adult RTRs who were at least 1 year posttransplant , taking tacrolimus or cyclosporine and served by a specialty pharmacy . Pharmacy refill records were used to measure adherence and monthly question naires were used to measure healthcare utilizations . Direct medical costs were estimated using the 2009 Medicare Expenditure Panel Survey . Adherence was analyzed using the GLM procedure and the MIXED procedure of SAS . Rate ratios and 95 % confidence intervals were estimated to quantify the rate of utilizing healthcare services relative to treatment assignment . One hundred fifty RTRs were enrolled in the study . Intervention group RTRs ( n = 76 ) had higher adherence than control group RTRs ( n = 74 ) over the study period ( p < 0.01 ) . And 76.1 % of the intervention group compared with 42.7 % of the control group was not hospitalized during the 1‐year study period ( RR = 1.785 ; 95 % CI : 1.314 , 2.425 ) , result ing in cost savings . Thus , evidence supports using behavioral contracts as an effective adherence intervention that may improve healthcare outcomes and lower costs Russell C , Conn V , Ashbaugh C , Madsen R , Wakefield M , Webb A , Coffey D , Peace L. Taking immunosuppressive medications effectively ( TIMELink ) : a pilot r and omized controlled trial in adult kidney transplant recipients . Clin Transplant 2011 : 25 : 864–870 . © 2010 John Wiley & Sons Background Mobile phone based programs for kidney transplant recipients are promising tools for improving long-term graft outcomes and better managing comorbidities ( eg , hypertension , diabetes ) . These tools provide an easy to use self-management framework allowing optimal medication adherence that is guided by the patients ’ physiological data . This technology is also relatively inexpensive , has an intuitive interface , and provides the capability for real-time personalized feedback to help motivate patient self-efficacy . Automated summary reports of patients ’ adherence and blood pressure can easily be uploaded to providers ’ networks helping reduce clinical inertia by reducing regimen alteration time . Objective The aim of this study was to assess the feasibility , acceptability , and preliminary outcomes of a prototype mobile health ( mHealth ) medication and blood pressure ( BP ) self-management system for kidney transplant patients with uncontrolled hypertension . Methods A smartphone enabled medication adherence and BP self-management system was developed using a patient and provider centered design . The development framework utilized self-determination theory with iterative stages that were guided and refined based on patient/provider feedback . A 3-month proof-of-concept r and omized controlled trial was conducted in 20 hypertensive kidney transplant patients identified as non-adherent to their current medication regimen based on a month long screening using an electronic medication tray . Participants r and omized to the mHealth intervention had the reminder functions of their electronic medication tray enabled and received a bluetooth capable BP monitor and a smartphone that received and transmitted encrypted physiological data and delivered reminders to measure BP using text messaging . Controls received st and ard of care and their adherence continued to be monitored with the medication tray reminders turned off . Providers received weekly summary reports of patient medication adherence and BP readings . Results Participation and retention rates were 41/55 ( 75 % ) and 31/34 ( 91 % ) , respectively . The prototype system appears to be safe , highly acceptable , and useful to patients and providers . Compared to the st and ard care control group ( SC ) , the mHealth intervention group exhibited significant improvements in medication adherence and significant reductions in clinic-measured systolic blood pressures across the monthly evaluations . Physicians made more anti-hypertensive medication adjustments in the mHealth group versus the st and ard care group ( 7 adjustments in 5 patients versus 3 adjustments in 3 patients ) during the 3-month trial based on the information provided in the weekly reports . Conclusions These data support the acceptability and feasibility of the prototype mHealth system . Further trials with larger sample sizes and additional biomarkers ( eg , whole blood medication levels ) are needed to examine efficacy and effectiveness of the system for improving medication adherence and blood pressure control after kidney transplantation over longer time periods . Trial Registration Clinical trials.gov NCT01859273 ; http:// clinical trials.gov/ct2/show/NCT01859273 ( Archived by WebCite at http://www.webcitation.org/6IqfCa3A3 ) ONCOMPLIANCE posttransplant is postulated to account for up to one third of graft failures due to chronic graft dysfunction . Due to its covert nature , determining the extent of the problem is not easy , and traditional methods tend to underestimate the true scale . More recently , methods of electronic monitoring have been introduced that tend to give a more accurate picture . One hundred stable renal transplant patients ( transplanted 1 year ) were approached and asked if they would use a “ smart top ” pill bottle ( Aardex , Switzerl and ) for their azathioprine/ prednisolone . The tops contain a microprocessor that records the date and time on each occasion the bottle is opened . This information can then be downloaded onto a computer via a modem at their regular clinic visits . The patients were r and omly assigned to groups ; 75 were given smart top bottles , and the other 25 were given plain tops . This latter group received regular interviews by a nurse practitioner and pill counts to assess their compliance . Of 92 patients whose data was available after 3 months ( 93 days ) , 11 ( 46 % ) of the plain top group and 31 ( 46 % ) of the smart top group missed at least one dose in the 3-month period . Twenty-two ( 33 % ) of the smart top group took extra doses in the 3-month period , none of the plain top group were found to have taken extra doses . Only 13 ( 54 % ) of the plain top group and 25 ( 37 % ) of the smart top group were 100 % compliant in the 3-month period ( not significant , chi-square test ) . Both electronic monitoring and nurse practitioner interviews with pill counting appear to be equally sensitive for detecting missed doses , but electronic monitoring measures timing of dosage and can also pick up when consecutive doses are missed . It also picks up when extra doses are taken . Missed doses and extra doses can cancel each other out when pill counts alone are used , which probably accounts for the higher 100 % compliance rate in the plain top group . METHOD One hundred stable renal transplant patients more than 1 year posttransplant were asked if they would use a smart top bottle for their regular once-daily azathioprine or prednisolone . Smart top bottles are medicine bottles with a microprocessor in the cap that records the date and time on each occasion the bottle is opened and closed . This information can then be downloaded onto a computer data base via a special modem at their regular outpatient visits . The patients were r and omly placed into one of two groups . Twenty-five of the patients were given a pill bottle with an ordinary lid on it . They were asked to bring their pill bottles with them to their regular outpatient clinic appointments , at approximately 3-month intervals , along with any remaining medication . They were then interviewed by a nurse practitioner about their compliance , and their remaining tablets were counted . The other 75 patients were given smart top bottles that they were asked to bring with them to their regular out patient appointments . The information was then downloaded from the lid onto the computer data base Background : Non‐compliance with immunosuppressive medications may result in allograft rejection and is regarded as an important impediment to post‐transplant care . This r and omized , controlled trial evaluates the impact of clinical pharmacy services on renal transplant patients ’ compliance with immunosuppressive agents . Methods : Patients who received a renal transplant at the Medical College of Georgia from February 1997 through January 1999 were r and omized in the intervention or control group provided they met study criteria . In addition to routine clinic services at each clinic visit , patients in the intervention group received clinical pharmacy services , which included medication histories and review of patients ’ medications with an emphasis on optimizing medication therapy to achieve desired outcomes and minimizing adverse medication events . The clinical pharmacist also provided recommendations to the nephrologists with the goal of achieving desired outcomes . To promote medication compliance by using compliance enhancement strategies , the clinical pharmacist counseled patients concerning their medication therapy and instructed them how to properly take their medications . Patients in the control group received the same routine clinic services as the intervention group except that they did not have any clinical pharmacist interaction . Compliance rate ( CR ) was calculated and patient 's compliance status was determined from the CR . The CR , the fraction of patients remaining compliant for each month , and the mean time patients were compliant were compared between groups . Whether there was a difference in the frequency of patients achieving ‘ target ’ immunosuppressive levels in the control and study groups was evaluated . Results : The mean CR for patients who had clinical pharmacist intervention ( n=12 ) was statistically higher than the control group 's ( n=12 ) mean CR ( p<0.001 ) . During the 12‐month post‐transplant study period , patients in the intervention group had a longer duration of compliance than patients in the control group ( p<0.05 ) . Additionally , patients who had clinical pharmacy services had a greater achievement of ‘ target ’ levels than patients who did not receive these services ( p<0.05 ) . Conclusions : Patients who received clinical pharmacy services with traditional patient care services had better compliance with immunosuppressants than patients who only received traditional patient care services . Results of this study suggest a multidisciplinary team that includes a clinical pharmacist as part of the care for post‐transplant patients is beneficial for enhancing medication compliance Purpose Solid-organ transplant recipients present a high rate of non-adherence to drug treatment . Few interventional studies have included approaches aim ed at increasing adherence . The objective of this study was to evaluate the impact of an educational and behavioral strategy on treatment adherence of kidney transplant recipients . Methods In a r and omized prospect i ve study , incident renal transplant patients ( n = 111 ) were divided into two groups : control group ( received usual transplant patient education ) and treatment group ( usual transplant patient education plus ten additional weekly 30-min education/counseling sessions about immunosuppressive drugs and behavioral changes ) . Treatment adherence was assessed using ITAS adherence question naire after 3 months . Renal function at 3 , 6 , and 12 months , and the incidence of transplant rejection were evaluated . Results The non-adherence rates were 46.4 and 14.5 % in the control and treatment groups ( p = 0.001 ) , respectively . The relative risk for non-adherence was 2.59 times ( CI 1.38–4.88 ) higher in the control group . Multivariate analysis demonstrated a 5.84 times ( CI 1.8–18.8 , p = 0.003 ) higher risk of non-adherence in the control group . There were no differences in renal function and rejection rates between groups . Conclusions A behavioral and educational strategy addressing the patient ’s perceptions and knowledge about the anti-rejection drugs significantly improved the short-term adherence to immunosuppressive therapy BACKGROUND Medication adherence is critical for transplant patients because the consequences of non-adherence can result in allograft loss and may be life threatening . METHODS A prospect i ve study with 74 renal transplant recipients using a sequential control group design was performed to investigate the impact of a pharmaceutical intensified care programme led by a clinical pharmacist on daily drug adherence during the first year after renal transplantation . Thirty-nine patients of the control group received the already established st and ardized drug and transplant training , while 35 patients of the intensified care group ( ICG ) received additional inpatient and outpatient pharmaceutical care and counselling by a dedicated clinical pharmacist . Applied interventions were clustered and classified using the behaviour change technique taxonomy according to Michie . Adherence to immunosuppressive drug therapy was monitored
Output:
| Intervention programs design ed to increase immunosuppressive adherence in patients with kidney transplant improve treatment adherence |
MS213431 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Objective : To determine if ketoconazole , a thromboxane A2 synthetase inhibitor , given within the first 24 hrs after diagnosis and arrival in the intensive care unit ( ICU ) would decrease the frequency of adult respiratory distress syndrome in the septic patient population . Design : Prospect i ve , r and omized , double-blind , placeocontrolled study . Setting : Twelve-bed , surgical ICU in a university-affiliated hospital . Patients : Fifty-four consecutive patients admitted to the surgical ICU with the diagnosis of sepsis composed the study sample . Sepsis was defined as including two or more of the following signs in a patient with a systolic blood pressure of < 80 mm Hg or a systemic vascular resistance of < 800 dyne-sec/cm5 : a ) temperature ≥39 ° C or ≤35 ° C ; b ) white blood cell count of > 12,000 leukocytes , or ≤4000 leukocytes/μL , or ≥20 % immature cells ; c ) positive blood culture ; d ) known or strongly suspected source of infection from which a known pathogen was cultured . Interventions : Patients were r and omized to receive either ketoconazole ( 400 mg ) or placebo in a double-blind fashion as early as possible and in < 24 hrs after surgical ICU admission or after the diagnosis of sepsis was established . Measurements and Main Results : Adult respiratory distress syndrome ( ARDS ) was diagnosed if the following criteria were met : a ) intrapulmonary shunt of > 20 % , or a PaO2/Fio2 ratio of < 150 requiring ventilatory support for > 48 hrs ; b ) pulmonary artery occlusion pressure of < 18 nun Hg and no clinical signs of heart failure ; and c ) diffuse infiltrates on chest radiograph . Treatment result ed in significant ( p = .002 ) reduction in the frequency of ARDS compared with the placebo group , 64 % vs. 15 % in the ketoconazole treated group . The mortality rate was also reduced from 39 % in the placebo group to 15 % in the ketoconazole group ( p = .05 ) . A statistically significant reduction in ventilator and ICU days was not achieved . Conclusions : Ketoconazole ( 400 mg through the gastrointestinal tract ) given early in the septic course may prevent ARDS and decrease the mortality rate in high-risk , septic patients . ( Crit Care Med 1993 ; 21:1635–1642 Objective To determine whether caloric intake is associated with risk of nosocomial bloodstream infection in critically ill medical patients . Design Prospect i ve cohort study . Setting Urban , academic medical intensive care unit . Patients Patients were 138 adult patients who did not take food by mouth for ≥96 hrs after medical intensive care unit admission . Measurements Daily caloric intake was recorded for each patient . Participants subsequently were grouped into one of four categories of caloric intake : < 25 % , 25–49 % , 50–74 % , and ≥75 % of average daily recommended calories based on the American College of Chest Physicians guidelines . Simplified Acute Physiology Score II and serum albumin were measured on medical intensive care unit admission . Serum glucose ( average value and maximum value each day ) and route of feeding ( enteral , parenteral , or both ) were collected daily . Nosocomial bloodstream infections were identified by infection control surveillance methods . Main Results The overall mean ( ±sd ) daily caloric intake for all study participants was 49.4 ± 29.3 % of American College of Chest Physicians guidelines . Nosocomial bloodstream infection occurred in 31 ( 22.4 % ) participants . Bivariate Cox analysis revealed that receiving ≥25 % of recommended calories compared with < 25 % was associated with significantly lower risk of bloodstream infection ( relative hazard , 0.24 ; 95 % confidence interval , 0.10–0.60 ) . Simplified Acute Physiology Score II also was associated with risk of nosocomial bloodstream infection ( relative hazard , 1.27 ; 95 % confidence interval , 1.01–1.60 ) . Average daily serum glucose , admission serum albumin , time to initiating nutritional support , and route of nutrition did not affect risk of bloodstream infection . After adjustment for Simplified Acute Physiology Score II in a multivariable analysis , receiving ≥25 % of recommended calories was associated with a significantly lower risk of bloodstream infection ( relative hazard , 0.27 ; 95 % confidence interval , 0.11–0.68 ) . Conclusions In the context of reducing risk of nosocomial bloodstream infections , failing to provide ≥25 % of the recommended calories may be harmful . Higher caloric goals may be necessary to achieve other clinical ly important outcomes We examined the effect of ventilation strategy on lung inflammatory mediators in the presence and absence of a preexisting inflammatory stimulus . 55 Sprague-Dawley rats were r and omized to either intravenous saline or lipopolysaccharide ( LPS ) . After 50 min of spontaneous respiration , the lungs were excised and r and omized to 2 h of ventilation with one of four strategies : ( a ) control ( C ) , tidal volume ( Vt ) = 7 cc/kg , positive end expiratory pressure ( PEEP ) = 3 cm H2O ; ( b ) moderate volume , high PEEP ( MVHP ) , Vt = 15 cc/kg ; PEEP = 10 cm H2O ; ( c ) moderate volume , zero PEEP ( MVZP ) , Vt = 15 cc/kg , PEEP = 0 ; or ( d ) high volume , zero PEEP ( HVZP ) , Vt = 40 cc/kg , PEEP = 0 . Ventilation with zero PEEP ( MVZP , HVZP ) result ed in significant reductions in lung compliance . Lung lavage levels of TNFalpha , IL-1beta , IL-6 , IL-10 , MIP-2 , and IFNgamma were measured by ELISA . Zero PEEP in combination with high volume ventilation ( HVZP ) had a synergistic effect on cytokine levels ( e.g. , 56-fold increase of TNFalpha versus controls ) . Identical end inspiratory lung distention with PEEP ( MVHP ) result ed in only a three-fold increase in TNFalpha , whereas MVZP produced a six-fold increase in lavage TNFalpha . Northern blot analysis revealed a similar pattern ( C , MVHP < MVZP < HVZP ) for induction of c-fos mRNA . These data support the concept that mechanical ventilation can have a significant influence on the inflammatory/anti-inflammatory milieu of the lung , and thus may play a role in initiating or propagating a local , and possibly systemic inflammatory response OBJECTIVES Recent studies in animal models of sepsis-induced acute respiratory distress syndrome ( ARDS ) have shown that a low-carbohydrate , high-fat diet combining the anti-inflammatory and vasodilatory properties of eicosapentaenoic acid ( EPA ; fish oil ) , gamma-linolenic acid ( GLA ; borage oil ) ( EPA+GLA ) , and antioxidants improves lung microvascular permeability , oxygenation , and cardiopulmonary function and reduces proinflammatory eicosanoid synthesis and lung inflammation . These findings suggest that enteral nutrition with EPA+GLA and antioxidants may reduce pulmonary inflammation and may improve oxygenation and clinical outcomes in patients with ARDS . DESIGN Prospect i ve , multicentered , double-blind , r and omized controlled trial . SETTING Intensive care units of five academic and teaching hospitals in the United States . PATIENTS We enrolled 146 patients with ARDS ( as defined by the American-European Consensus Conference ) caused by sepsis/pneumonia , trauma , or aspiration injury in the study . INTERVENTIONS Patients meeting entry criteria were r and omized and continuously tube-fed either EPA+GLA or an isonitrogenous , isocaloric st and ard diet at a minimum caloric delivery of 75 % of basal energy expenditure x 1.3 for at least 4 - 7 days . MEASUREMENTS AND MAIN RESULTS Arterial blood gases were measured , and ventilator setting s were recorded at baseline and study days 4 and 7 to enable calculation of PaO2/FIO2 , a measure of gas exchange . Pulmonary neutrophil recruitment was assessed by measuring the number of neutrophils and the total cell count in bronchoalveolar lavage fluid at the same time points . Clinical outcomes were recorded . Baseline characteristics of 98 evaluable patients revealed that key demographic , physiologic , and ventilatory variables were similar at entry between both groups . Multiple bronchoalveolar lavages revealed significant decreases ( approximately 2.5-fold ) in the number of total cells and neutrophils per mL of recovered lavage fluid during the study with EPA+GLA compared with patients fed the control diet . Significant improvements in oxygenation ( PaO2/FIO2 ) from baseline to study days 4 and 7 with lower ventilation variables ( FIO2 , positive end-expiratory pressure , and minute ventilation ) occurred in patients fed EPA+GLA compared with controls . Patients fed EPA+GLA required significantly fewer days of ventilatory support ( 11 vs. 16.3 days ; p = .011 ) , and had a decreased length of stay in the intensive care unit ( 12.8 vs. 17.5 days ; p = .016 ) compared with controls . Only four of 51 ( 8 % ) patients fed EPA+GLA vs. 13 of 47 ( 28 % ) control patients developed a new organ failure during the study ( p = .015 ) . CONCLUSIONS The beneficial effects of the EPA+GLA diet on pulmonary neutrophil recruitment , gas exchange , requirement for mechanical ventilation , length of intensive care unit stay , and the reduction of new organ failures suggest that this enteral nutrition formula would be a useful adjuvant therapy in the clinical management of patients with or at risk of developing ARDS Objective : It has been shown in a two-center study that high positive end-expiratory pressure ( PEEP ) and low tidal volume ( LTV ) improved outcome in ARDS . However , that study involved patients with underlying diseases unique to the study area , was conducted at only two centers , and enrolled a small number of patients . We similarly hypothesized that a ventilatory strategy based on PEEP above the lower inflection point of the pressure volume curve of the respiratory system ( Pflex ) set on day 1 with a low tidal volume would result in improved outcome in patients with severe and persistent acute respiratory distress syndrome ( ARDS ) . Design : R and omized , controlled clinical trial . Setting : Network of eight Spanish multidisciplinary intensive care units ( ICUs ) under the acronym of ARIES ( Acute Respiratory Insufficiency : España Study ) . Patients : All consecutive patients admitted into participating Spanish ICUs from March 1999 to March 2001 with a diagnosis of ARDS were considered for the study . If 24 hrs after meeting ARDS criteria , the Pao2/Fio2 remained ≤200 mm Hg on st and ard ventilator setting s , patients were r and omized into two groups : control and Pflex/LTV . Interventions : In the control group , tidal volume was 9–11 mL/kg of predicted body weight ( PBW ) and PEEP ≥5 cm H2O . In the Pflex/LTV group , tidal volume was 5–8 mL/kg PBW and PEEP was set on day 1 at Pflex + 2 cm H2O . In both groups , Fio2 was set to maintain arterial oxygen saturation > 90 % and Pao2 70–100 mm Hg , and respiratory rate was adjusted to maintain Paco2 between 35 and 50 mm Hg . Measurements and Main Results : The study was stopped early based on an efficacy stopping rule as described in the methods . Of 103 patients who were enrolled ( 50 control and 53 Pflex ) , eight patients ( five in control , three in Pflex ) were excluded from the final evaluation because the r and om group assignment was not performed in one center according to protocol . Main outcome measures were ICU and hospital mortality , ventilator-free days , and nonpulmonary organ dysfunction . ICU mortality ( 24 of 45 [ 53.3 % ] vs. 16 of 50 [ 32 % ] , p = .040 ) , hospital mortality ( 25 of 45 [ 55.5 % ] vs. 17 of 50 [ 34 % ] , p = .041 ) , and ventilator-free days at day 28 ( 6.02 ± 7.95 in control and 10.90 ± 9.45 in Pflex/LTV , p = .008 ) all favored Pflex/LTV . The mean difference in the number of additional organ failures postr and omization was higher in the control group ( p < .001 ) . Conclusions : A mechanical ventilation strategy with a PEEP level set on day 1 above Pflex and a low tidal volume compared with a strategy with a higher tidal volume and relatively low PEEP has a beneficial impact on outcome in patients with severe and persistent ARDS OBJECTIVE To determine whether the implementation of a nutritional management protocol in the ICU leads to the increased use of enteral nutrition , earlier feeding , and improved clinical outcomes in patients . DESIGN Prospect i ve evaluation of critically ill patients before and after the introduction of an
Output:
| Grasso S , Stripoli T , De Michele M , et al. ARDSnet ventilatory protocol and alveolar hyperinflation : role of positive endexpiratory pressure . |
MS213432 | ***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 Chromoendoscopy can accurately differentiate neoplastic from nonneoplastic polyps in the colon . Narrow b and imaging ( NBI ) has been described as " electronic chromoendoscopy , " but it is unclear whether pit patterns seen with chromoendoscopy are identical to those with NBI . OBJECTIVE Pilot study to compare features of diminutive polyps assessed with magnification NBI and chromoendoscopy . DESIGN Prospect i ve polyp series . SETTING Single tertiary referral center in the United Kingdom . PATIENTS Twenty patients seen for routine colonoscopy . INTERVENTION Digital images of each polyp recorded with NBI and chromoendoscopy were subsequently assessed as single images in a r and om order and as paired polyp images by experienced European- and Japanese-trained endoscopists . MAIN OUTCOME MEASUREMENTS Pit pattern ( Kudo classification ) ; vascular pattern intensity ( weak , normal , strong ) ; predicted histology ; pit pattern and vessel network clarity ( scale 1 - 3 , 1 poor , 3 excellent ) . RESULTS A total of 33 polyps < or=6 mm were assessed . Chromoendoscopic and NBI pit patterns were different for 12 and 20 of 33 polyps ( Japanese and European , respectively ) , combined kappa 0.23 , P < .001 compared with published intraobsever variation . Sensitivity , specificity , and accuracy for neoplasia were comparable for chromoendoscopic and NBI pit patterns and vascular pattern intensity for both observers . Vessel network clarity was better with NBI , P < .001 ( both ) , as was pit pattern clarity , P = .04 ( European ) . LIMITATIONS Small sample size ; pilot study . CONCLUSIONS Pit patterns were not always identical with NBI and chromoendoscopy . The Kudo classification may need to be modified and revali date d before it can be used with confidence with NBI . Vascular pattern intensity , a simple color change , appears as accurate as pit pattern Objective Cap-assisted colonoscopy ( CAC ) uses a small plastic transparent cap attached to the tip of the colonoscope that can depress and flatten colonic folds and thus improve visualisation of their proximal aspects . The aim of this study was to compare CAC with st and ard colonoscopy ( SC ; high-definition white light ) for adenoma detection rates . Design This is a prospect i ve r and omised controlled trial . Setting The study was performed in a tertiary-care Veterans Affairs Medical Center in the USA . Patients Subjects undergoing screening or surveillance colonoscopy were enrolled . Interventions Subjects were r and omised to undergo either CAC or SC . Main outcome measures The outcome measures were the proportion of subjects with at least one adenoma , the number of adenomas detected per subject , insertion time , caecal intubation rates and complications . Results 420 subjects were enrolled and included in the study ( 210 in each group ) . The proportion of subjects with at least one adenoma was higher with CAC compared to SC ( 69 % vs 56 % , p=0.009 ) . CAC also detected a higher number of adenomas per subject ( 2.3 vs 1.4 , p<0.001 ) . The caecal intubation time was shorter with CAC ( 3.29 min vs 3.98 min , p<0.001 ) . The caecal intubation rates were similar in the two groups ( 99 % vs 98 % , p=0.37 ) . There were no complications associated with CAC or SC . Conclusions CAC detected a 13 % higher number of subjects with at least one adenoma and 59 % higher adenomas per subject . CAC is a safe , effective and practical means to improve adenoma detection rates . Clinical Trial Registration NCT 01211132 Objectives Colonoscopy is central to colorectal cancer ( CRC ) screening . Success of CRC screening is dependent on colonoscopy quality . The NHS Bowel Cancer Screening Programme ( BCSP ) offers biennial faecal occult blood ( FOB ) testing to 60–74 year olds and colonoscopy to those with positive FOB tests . All colonoscopists in the screening programme are required to meet predetermined st and ards before starting screening and are subject to ongoing quality assurance . In this study , the authors examine the quality of colonoscopy in the NHS BCSP and describe new and established measures to assess and maintain quality . Design The NHS BCSP data base collects detailed data on all screening colonoscopies . Prospect ively collected data from the first 3 years of the programme ( August 2006 to August 2009 ) were analysed . Colonoscopy quality indicators ( adenoma detection rate ( ADR ) , polyp detection rate , colonoscopy withdrawal time , caecal intubation rate , rectal retroversion rate , polyp retrieval rate , mean sedation doses , patient comfort scores , bowel preparation quality and adverse event incidence ) were calculated along with measures of total adenoma detection . Results 2 269 983 individuals returned FOB tests leading to 36 460 colonoscopies . Mean unadjusted caecal intubation rate was 95.2 % , and mean withdrawal time for normal procedures was 9.2 min . The mean ADR per colonoscopist was 46.5 % . The mean number of adenomas per procedure ( MAP ) was 0.91 ; the mean number of adenomas per positive procedure ( MAP+ ) was 1.94 . Perforation occurred after 0.09 % of procedures . There were no procedure-related deaths . Conclusions The NHS BCSP provides high- quality colonoscopy , as demonstrated by high caecal intubation rate , ADR and comfort scores , and low adverse event rates . Quality is achieved by ensuring BCSP colonoscopists meet a high st and ard before starting screening and through ongoing quality assurance . Measuring total adenoma detection ( MAP and MAP+ ) as adjuncts to ADR may further enhance quality assurance Background Diminutive ( ≤5 mm ) colorectal polyps are common , and overwhelmingly benign . Routinely , after polypectomy , they are examined pathologically to determine the surveillance intervals . Advances in equipment and techniques , such as narrow-b and imaging ( NBI ) colonoscopy , now permit reliable real-time optical diagnosis . Methods We conducted a r and omised single-masked study involving three institutions to determine whether optical diagnosis of diminutive colorectal polyps meets clinical practice st and ards and reduces the need for histopathology . We r and omly assigned eligible patients undergoing routine high-definition colonoscopy to optical diagnosis using near focus versus st and ard view , using computer-generated block sequence . By vali date d criteria , we rendered an optical diagnosis and a confidence level ( high vs low ) for all polyps , using NBI . Our primary endpoint was the number of accurate high-confidence optical diagnoses compared with central blinded pathology in the two groups . We analysed data using intention to treat . Findings We enrolled 558 subjects , and r and omly assigned 281 to near focus and 277 to st and ard view optical diagnosis . We detected 1309 predominantly diminutive ( 74.5 % ) and neoplastic ( 60.0 % ) polyps . Endoscopists were significantly more likely , OR 2.2 ( 95 % CI 1.6 to 3.0 , p<0.0001 ) , to make a high-confidence optical diagnosis with near focus ( 85.1 % ) than st and ard ( 72.6 % ) view . High-confidence diagnoses had 96.4 % and 92.0 % negative predictive value , respectively . Of all polyps , 75.3 % ( 95 % CI71.3 % to 78.9 % ) had a high-confidence accurate prediction using near focus , compared with 63.1 % ( 95 % CI 58.5 % to 67.6 % ) using st and ard view . Optical versus histopathological diagnosis showed excellent agreement between the surveillance intervals , 93.5 % in near focus and 92.2 % in st and ard view . The median diagnosis time was 14 s. Conclusions Real-time optical diagnosis using NBI colonoscopy may replace the pathology diagnosis for the majority of diminutive colorectal polyps . Using colonoscopy with near focus view increases the confidence level of the optical diagnosis . Optical diagnosis would be a paradigm shift in clinical practice of colonoscopy for colorectal cancer screening . Trial registration number Clinical Trials.gov Identifier : NCT01288833 BACKGROUND The EPKi system ( Pentax , Japan ) enables resolution above HDTV . Aim of the study was to test the efficacy of HD+ alone and with the new post-processing digital filter i-Scan or chromoendoscopy ( Methylene blue 0.1 % ) in screening for colorectal cancer . We focused on lesions less than 5 mm as a surrogate marker for the optical possibilities of the EPKi system . METHODS The last 30 cm of the colon in a screening population were inspected with HD+ alone , in combination with i-Scan ( 2:1 r and omisation ) and subsequently with chromoendoscopy . All lesions were characterized and targeted biopsies were performed . RESULTS i-Scan augmented in 69 patients the identification of lesions from 176 to 335 ( p<0.001 ) and chromoendoscopy to 646 ( p<0.001 ) . The additional lesions were mainly flat ( type IIb , 74 % ) , which were only recognized using i-Scan or chromoendoscopy . The amount of neoplasias was not significantly different ( HD+ : 5 , i-Scan : 11 , Chromoendoscopy : 11 ) , but all could correctly be predicted using i-Scan or chromoendoscopy . CONCLUSIONS HD+ colonoscopy with and without i-Scan unmask a plethora of small lesions but chromoendoscopy can even advance the number . However , i-Scan was able to predict neoplasia as precisely as chromoendoscopy and might shortly replace chromoendoscopy as a more time efficient tool BACKGROUND AND STUDY AIMS Narrow-b and imaging ( NBI ) has shown promising results in discriminating adenomatous from non-adenomatous colonic polyps . In patients with small polyps ( < 10 mm ) , the application of NBI within a " resect and discard " strategy , might allow post-polypectomy surveillance intervals to be determined independently from histopathology . The aim of the present study was to assess the feasibility and safety of this approach in routine clinical practice . PATIENTS AND METHODS Consecutive colonoscopy out patients with one or more polyps smaller than 10 mm were prospect ively included . Each polyp was categorized by the endoscopist as adenoma or non-adenoma according to simplified NBI criteria , and future post-polypectomy surveillance interval was assigned accordingly . Following histopathology , post-polypectomy surveillance interval was subsequently re-assigned , and the accordance between endoscopy- and histology-directed surveillance strategies was calculated . RESULTS Among 942 colonoscopy patients , 286 ( 30.4 % ) with only small polyps were included . In total , 511 small polyps were evaluated ; 350 ( 68.5 % ) were adenomas and 18 of these ( 5.1 % ) had histologic features of advanced neoplasia . For the in vivo diagnosis of adenoma , NBI sensitivity , specificity , accuracy , and positive and negative likelihood ratios were 94.9 % , 65.8 % , 85.7 % , 2.80 , and 0.08 , respectively . The endoscopy-directed surveillance strategy was in accordance with the histology-directed strategy in 237 of 286 patients ( 82.9 % ) . In 9.8 % and 7.3 % patients , the endoscopy-directed approach would have result ed in early and delayed surveillance , respectively . CONCLUSIONS The resect and discard strategy seems to be a viable , safe , and cost-effective approach for the management of patients with small polyps . However , caution in the application of the strategy should be advocated for patients with polyps 6 - 9 mm in size and those with right-sided lesions , due to their malignant potential . The study was registered on Clinical trials.gov ( NCT01462123 ) OBJECTIVES : St and ard white light colonoscopy has limited ability to differentiate between polyp types ( adenomatous vs. hyperplastic ) . Narrow b and imaging ( NBI ) highlights the superficial mucosal/vascular patterns on polyps and may facilitate real-time characterization of polyp histology . The aim of this study was to prospect ively evaluate and compare the diagnostic characteristics of high-definition white light colonoscopy ( HDWL ) and NBI without magnification in the real-time prediction of polyp histology ( adenomatous vs. hyperplastic ) by evaluating the surface mucosal and vascular patterns . METHODS : We conducted a prospect i ve comparative study in a tertiary referral center . A total of 100 patients referred for screening or surveillance colonoscopy were prospect ively enrolled and underwent colonoscopy using a high-definition colonoscope with NBI capability . Every polyp detected was initially evaluated with HDWL followed by NBI for the presence of surface mucosal/vascular patterns . Based on these patterns , polyp histology was predicted by both modalities . The main outcome measurements were : ( i ) diagnostic characteristics of HDWL and NBI in predicting polyp histology and ( ii ) impact of polyp size and learning effect ( first half of study vs. second half ) on the ability of NBI to predict adenomas . RESULTS : A total of 236 polyps were detected in 100 patients —143 adenomas ,
Output:
| VCE technologies , using HD systems without magnification , could potentially be used for the real-time assessment of diminutive colorectal polyps , if endoscopists have adequate experience and training . |
MS213433 | ***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 The aim of this open-label pilot study was to evaluate the utility of divalproex in decreasing cocaine use and stabilizing mood symptoms among patients with bipolar disorder with comorbid cocaine dependence . METHOD Fifteen patients enrolled in the study and seven met final inclusion criteria of DSM-IV/SCID diagnoses of bipolar I disorder and comorbid cocaine dependence with active cocaine use . Patients were started on open-label divalproex . After stabilization on divalproex sodium , weekly assessment s were undertaken for 8weeks . Subjects also attended dual recovery counseling . RESULTS The results revealed significant improvement on % cocaine abstinent days , dollars spent on cocaine , ASI 's drug use severity index , % alcohol abstinent days , drinks per drinking day , marijuana use and cigarettes smoking . They also had significant improvement on manic , depressive , and sleep symptoms and on functioning . There were no reported adverse events or increases in liver function tests . CONCLUSION The results of this open-label study point to the potential utility of divalproex in patients with bipolar disorder and primary cocaine dependence . Double-blind , placebo-controlled studies to fully evaluate the efficacy of divalproex in this high risk clinical population are warranted BACKGROUND Substance abuse frequently complicates the course of bipolar illness , promotes mixed states , and contributes to poor outcome in mania . Preliminary open trials suggest that anticonvulsant mood stabilizers may enhance remission rates and outcome for bipolar patients with substance abuse . This study compared remission patterns for mixed or pure manic episodes among bipolar in patients with or without substance abuse histories . METHOD Hospital records were retrospectively review ed for 204 DSM-III-R bipolar I in patients . Clinical features were compared for those with or without substance abuse/dependence histories predating the index manic episode . Time until remission was analyzed by Kaplan-Meier survival analysis . Naturalistic treatment outcome with lithium or anticonvulsant mood stabilizers was compared for those with or without past substance abuse . RESULTS Past substance abuse was evident in 34 % of the bipolar sample and comprised most often alcoholism ( 82 % ) , followed by cocaine ( 30 % ) , marijuana ( 29 % ) , sedative-hypnotic or amphetamine ( 21 % ) , and opiate ( 13 % ) abuse . Substance abuse was more common among men ( p < .05 ) and those with mixed rather than pure mania ( p < .05 ) . Remission during hospitalization was less likely among patients with prior substance abuse ( p < .05 ) , especially alcohol or marijuana abuse , and among mixed manic patients with past substance abuse ( p < .05 ) . Bipolar patients with substance abuse histories who received divalproex or carbamazepine remitted during hospitalization more often than did those who received lithium as the sole mood stabilizer ( p < .05 ) . CONCLUSION These findings support previous reports suggesting that bipolar patients with past substance abuse have poorer naturalistic treatment outcomes , but may show a better response to anticonvulsant mood stabilizers than lithium OBJECTIVE To evaluate the prevalence of substance abuse dependence and /or alcohol abuse dependence among subjects with bipolar I versus bipolar II disorder in a voluntary registry . METHOD One hundred r and omly selected registrants in a voluntary case registry for bipolar disorder were interviewed , using the Structured Clinical Interview for DSM-IV Axis I Disorders , to vali date the diagnosis of this registry . Corroborative information was obtained from medical records , family members and the treating psychiatrist . Eighty-nine adults ( 18 - 65 years ) met criteria for bipolar disorder ( bipolar I = 71 , bipolar II = 18 ) and were included in this analysis . RESULTS Forty-one ( 57.8 % ) subjects with bipolar I disorder abused , or were dependent on one or more substances or alcohol , 28.2 % abused , or were dependent on , two substances or alcohol , and 11.3 % abused or were dependent on three or more substances or alcohol . Nearly 39 % of bipolar II subjects abused or were dependent on one or more substances , nearly 17 % were dependent on two or more substances or alcohol , and 11 % were dependent on three or more substances or alcohol . Alcohol was the most commonly abused drug among either bipolar I or II subjects . CONCLUSIONS Consistent with other epidemiologic and hospital population studies , this voluntary bipolar disorder registry suggests a high prevalence of comorbidity with alcohol and /or substance abuse dependence . Bipolar I subjects appear to have higher rates of these comorbid conditions than bipolar II subjects ; however , as the number of bipolar II subjects was rather small , this suggestion needs confirmation OBJECTIVE Substance abuse is extremely common in patients with bipolar disorders , although minimal data are available on the treatment of this important clinical population . Aripiprazole is an atypical antipsychotic that is approved for the treatment of mania and that has a novel mechanism of action , acting as a dopamine-2 receptor partial agonist , thereby increasing dopamine release in some parts of the brain and decreasing dopa-mine release in other brain regions . Dopamine release is implicated in substance use , and both dopaminergic agonists and antagonists have been examined for the treatment of substance abuse . To our knowledge , dopa-mine receptor partial agonists have not been investigated for treatment of substance abuse in humans . METHOD Twenty antipsychotic-treated patients with bipolar or schizoaffective disorder and current substance abuse were switched to open-label aripipra-zole using an overlap and taper method . At baseline , diagnoses were confirmed using the Mini-International Neuropsychiatric Interview based on DSM-IV criteria . Psychiatric symptoms , side effects , and substance use and craving were assessed over 12 weeks . Psychiatric symptoms were assessed with the Hamilton Rating Scale for Depression ( HAM-D ) , Young Mania Rating Scale ( YMRS ) , and Brief Psychiatric Rating Scale ( BPRS ) . Substance craving was assessed with visual analogue scales , and side effects were monitored using the Abnormal Involuntary Movement Scale , Simpson-Angus Scale , Barnes Akathisia Scale , and patient report . Study enrollment was from April 2003 to February 2004 . RESULTS Significant baseline-to-exit improvement in HAM-D ( p = .002 ) , YMRS ( p = .021 ) , and BPRS ( p = .000 ) scores were observed without a significant change in antipsychotic-induced side effect scales . In 17 participants with current alcohol dependence , significant reductions in dollars spent on alcohol ( p = .042 ) and alcohol craving ( p = .003 ) were found . In 9 participants with cocaine-related disorders , significant reductions in cocaine craving ( p = .014 ) , but not use , were found . CONCLUSION A change to aripiprazole was associated with symptomatic improvement . Limitations of the study include a small sample size , high attrition , and an open-label design . Controlled trials in dual-diagnosis patients are needed to confirm these findings BACKGROUND Bipolar disorder is associated with the highest substance abuse rates of any psychiatric illness . Therefore , treatments that stabilize mood and decrease drug use or cravings are of great interest . Open-label lamotrigine was examined in 30 out patients with DSM-IV bipolar disorder and cocaine dependence . Lamotrigine was either added to existing medication regimens or used as monotherapy . METHOD Lamotrigine was started at a dose of 25 mg/day ( 12.5 mg/day in those taking valproic acid ) and titrated to a maximum dose of 300 mg/day . Subjects received a baseline evaluation including a structured clinical interview and weekly assessment s for 12 weeks with the Hamilton Rating Scale for Depression ( HAM-D ) , Young Mania Rating Scale ( YMRS ) , Brief Psychiatric Rating Scale ( BPRS ) , and Cocaine Craving Question naire ( CCQ ) . At each appointment , a urine sample was obtained , and participants reported drug use during the previous week . The subjects consisted of 13 men and 17 women with cocaine dependence and bipolar I disorder ( N = 22 ) , bipolar II disorder ( N = 7 ) , or bipolar disorder not otherwise specified ( N = 1 ) , with a mean + /- SD age of 35.4 + /- 7.2 years . Data were analyzed using the last observation carried forward on all subjects who completed the baseline evaluation and at least 1 postbaseline assessment . RESULTS Significant improvement was observed in HAM-D , YMRS , and BPRS scores ( p < or = .02 ) . Cravings also significantly decreased as measured by the CCQ ( p < .001 ) . Dollar amount spent on drugs decreased nonsignificantly . Lamotrigine was well tolerated , with no subjects discontinuing due to side effects . CONCLUSION Lamotrigine treatment was well tolerated in this sample and associated with statistically significant improvement in mood and drug cravings but not drug use . The findings suggest that larger controlled trials of lamotrigine are needed in this population OBJECTIVE Bipolar disorder is associated with the highest rates of substance abuse of any psychiatric illness . Therefore , treatments that stabilize mood and decrease drug use or cravings are of great interest . Atypical antipsychotics are in widespread use in patients with bipolar disorder . However , minimal data are available on their use in bipolar patients with comorbid substance abuse . METHODS Open-label , add-on , quetiapine therapy was examined for 12 weeks in 17 out patients with bipolar disorder and cocaine dependence . Subjects were evaluated with a structured clinical interview ; Hamilton Depression Rating ( HDRS ) , Young Mania Rating ( YMRS ) , Brief Psychiatric Rating ( BPRS ) scales ; and Cocaine Craving Question naire ( CCQ ) . Urine sample s and self-reported drug use were also obtained . Data were analyzed using a last observation carried forward method on all subjects given medication at baseline . RESULTS Significant improvement from baseline to exit was observed in HDRS , YMRS , BPRS and CCQ scores ( p < or = 0.05 ) . Dollars spent on cocaine and days/week of cocaine use decreased non-significantly , and urine drug screens did not change significantly from baseline to exit . Quetiapine was well tolerated , with no subjects to our knowledge discontinuing because of side-effects . CONCLUSIONS The use of quetiapine was associated with substantial improvement in psychiatric symptoms and cocaine cravings . The findings are promising and suggest larger controlled trials of quetiapine are needed in this population Despite the availability of efficacious treatments for bipolar disorder , their effectiveness in general clinical practice is greatly attenuated , result ing in what has been called an ' efficacy-effectiveness gap ' . In design ing VA Cooperative Studies Program ( CSP ) Study # 430 to address this gap , nine principles for conducting an effectiveness ( in contrast to an efficacy ) study were identified . These principles are presented and discussed , with specific aspects of CSP # 430 serving as illustrations of how they can be implemented in an actual study . CSP # 430 hypothesizes that an integrated , clinic-based treatment delivery system that emphasizes ( 1 ) algorithm-driven somatotherapy , ( 2 ) st and ardized patient education , and ( 3 ) easy access to a single primary mental health care provider to maximize continuity-of-care , will address the efficacy-effectiveness gap and improve disease , functional , and economic outcome . It is an 11-site , r and omized controlled clinical trial of this multi-modal , clinic-based intervention versus usual VA care running from 1997 to 2003 . The trial has enrolled 191 subjects in each arm , using minimal exclusion criteria to maximize the external validity of the study . Subjects are followed for 3 years . The intervention is highly specified in a series of operations manuals for each of the three components . Several continuous quality improvement ( CQI ) interventions , process measures , and statistical techniques deal with drift of care in both the intervention and usual care arms to ensure the internal validity of the study . CSP # 430 is design ed to have impact well beyond the VA , since it evaluates a basic health care operational principle : that augmenting ambulatory access for major mental illness will improve outcome and reduce overall treatment costs . If results are positive , this study will provide a reason to reconsider the prevailing trend toward limitation of ambulatory services that is characteristic of many managed care systems today OBJECTIVE Although bipolar disorder and substance use disorder frequently co-occur , there is little information on the effectiveness of behavioral treatment for this population . Integrated group therapy , which addresses the two disorders simultaneously , was compared with group drug counseling , which focuses on substance use . The authors hypothesized that patients receiving integrated group therapy would have fewer days of substance use and fewer weeks ill with bipolar disorder . METHOD A r and omized controlled trial compared 20 weeks of integrated group therapy or group drug counseling with 3 months of posttreatment follow-up . Sixty-two patients with bipolar disorder and current substance dependence , treated with mood stabilizers for > or=2 weeks , were r and omly assigned to integrated group therapy ( N=31 ) or group drug counseling ( N=31 ) . The primary outcome measure was the number of days of substance use . The primary mood outcome was the number of weeks ill with
Output:
| Recent research on the causal relationship between the two disorders suggests that a subgroup of bipolar patients may develop a relatively milder form of affective illness that is expressed only after extended exposure to alcohol abuse .
Three open label medication trials provide limited evidence that quetiapine , aripiprazole , and lamotrigine may be effective in treating affective and substance use symptoms in bipolar patients with cocaine dependence and that aripiprazole may also be helpful in patients with alcohol use disorders .
The two placebo controlled trials to date suggest that valproate given as an adjunct to lithium in bipolar patients with co-occurring alcohol dependence improves both mood and alcohol use symptoms and that lithium treatment in bipolar adolescents improves mood and SUD symptoms . |
MS213434 | ***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 r and omized , double-blind , placebo-controlled study evaluated whether lamivudine given during late pregnancy can reduce hepatitis B virus ( HBV ) perinatal transmission in highly viraemic mothers . Mothers were r and omized to either lamivudine 100 mg or placebo from week 32 of gestation to week 4 postpartum . At birth , infants received recombinant HBV vaccine with or without HBIg and were followed until week 52 . One hundred and fifty mothers , with a gestational age of 26 - 30 weeks and serum HBV DNA > 1000 MEq/mL ( bDNA assay ) , were treated . A total of 141 infants received immunoprophylaxis at birth . In lamivudine-treated mothers , 56 infants received vaccine + HBIg ( lamivudine + vaccine + HBIg ) and 26 infants received vaccine ( lamivudine + vaccine ) . In placebo-treated mothers , 59 infants received vaccine + HBIg ( placebo + vaccine + HBIg ) . At week 52 , in the primary analyses where missing data was counted as failures , infants in the lamivudine + vaccine + HBIg group had a significant decrease in incidence of HBsAg seropositivity ( 10/56 , 18%vs 23/59 , 39 % ; P = 0.014 ) and in detectable HBV DNA ( 11/56 , 20%vs 27/59 , 46 % ; P = 0.003 ) compared to infants in the placebo + vaccine + HBIg group . Sensitivity analyses to evaluate the impact of missing data at week 52 result ing from a high dropout rate ( 13 % in the lamivudine + vaccine + HBIg group and 31 % in the placebo + vaccine + HBIg group ) remained consistent with the primary analysis in that lower transmission rates were still observed in the infants of lamivudine-treated mothers , but the differences were not statistically significant . No safety concerns were noted in the lamivudine-treated mothers or their infants . Results of this study suggest that lamivudine reduced HBV transmission from highly viraemic mothers to their infants who received passive/active immunization The purpose of this study was to investigate the efficacy and safety of lamivudine ( LAM ) in stopping the vertical transmission of hepatitis B virus ( HBV ) . Pregnant women with normal alanine transaminase ( ALT ) ( n = 100 ) and with abnormal ALT ( n = 100 ) who were positive for hepatitis B e antigen ( HBeAg ) , and with HBV DNA ( deoxyribonucleic acid ) levels ≥1.0 × 107 copies/ml were enrolled in this study . One hundred volunteers ( 50 with normal ALT , 50 with abnormal ALT ) received 100 mg of LAM daily from the 24th to 32nd week of gestation and the untreated 100 volunteers served as controls . All infants received passive-active immunoprophylaxis . Compared to the control group , the study group got a marked reduction in serum levels ( P < 0.001 ) and high negativity ( P < 0.001 ) of HBV DNA before delivery . They also got normalization in ALT levels as much as controls received general medication ( P > 0.05 ) . The prenatal transmission rate in the study group was significantly lower than that of the control group ( P < 0.05 ) . There were no differences in incidences of congenital malformation between the two groups ( P > 0.05 ) . LAM treatment can effectively and safely stop vertical transmission of HBV and normalize the ALT levels of pregnant women BACKGROUND & AIMS Fetal safety of antiviral therapies is important given the long-term treatment of women with chronic hepatitis B ( CHB ) infection who may become pregnant . We analyzed neonatal safety data from the Antiretroviral Pregnancy Registry ( APR ) , the largest safety data base in pregnancy for antivirals used for HIV and CHB . METHODS Data were extracted from APR cases prospect ively enrolled between 1989 and 2011 . Primary outcomes were major birth defects rates with exposure to all antivirals , individual classes , and drugs compared to population -based controls . Relevant to CHB , only lamivudine ( LAM ) and tenofovir disoproxil fumarate ( TDF ) had sufficient individual data for review ( ≥200 cases ) . RESULTS Of 13,711 cases analyzed , the overall birth defect prevalence ( 2.8 % , 95 % CI 2.6 - 3.1 % ) was comparable to Centers for Disease Control population -based data ( 2.72 % , 2.68 - 2.76 % , p=0.87 ) and two prospect i ve antiretroviral exposed newborn cohorts ( 2.8 % , 2.5 - 3.2 % , p=0.90 and 1.5 % , 1.1 - 2.0 % , p<0.001 ) . The birth defects prevalence between first and second/third trimesters exposure was similar ( 3.0 % vs. 2.7 % ) . No increased risk of major birth defects with LAM or TDF exposure compared to population -based controls was observed . No specific pattern of major birth defects was observed for individual antivirals or overall . CONCLUSIONS No increased risk of major birth defects including in non-live births was observed for pregnant women exposed to antivirals relevant to CHB treatment overall or to LAM or TDF compared to population -based controls . Continued safety and efficacy reporting on antivirals in pregnancy are essential to inform patients on their risks and benefits during pregnancy OBJECTIVE To determine the rate of perinatal hepatitis B virus ( HBV ) transmission in an Australian setting and to identify maternal virological factors associated with highest risk of transmission . DESIGN , PARTICIPANTS AND SETTING A prospect i ve , observational study of perinatal transmission of HBV . Participants were pregnant women attending Sydney South West Area Health Service antenatal clinics who tested positive for hepatitis B surface antigen ( HBsAg ) , and their babies . All babies were routinely offered hepatitis B immunoglobulin ( HBIG ) and HBV vaccination . Babies positive for HBsAg at 9-month follow-up underwent further virological testing , including HBV DNA sequencing . The study was conducted between August 2002 and May 2008 . MAIN OUTCOME MEASURES HBV DNA levels and demographic characteristics of HBsAg-positive pregnant women ; proportion of their infants with active HBV infection at 9-month follow-up ; maternal characteristics affecting transmission rate ; HBV DNA sequencing of infected infants and their mothers . RESULTS Of 313 HBsAg-positive pregnant women , 213 ( 68 % ) were HBV DNA-positive and 92 ( 29 % ) were positive for hepatitis B " e " antigen ( HBeAg ) ; 138 babies born to HBV DNA-positive mothers were tested for HBV infection ( HBsAg positivity ) at about 9 months of age . Four cases of transmission were identified . All four mothers had very high HBV DNA levels ( > 10(8 ) copies/mL ) and were HBeAg-positive . Three of the four infants were infected with wild-type HBV strains , with identical maternal/infant isolates . The fourth mother-infant pair had an S gene variant , HBV D144E , which has been previously reported in association with vaccine/HBIG escape . ( Unfortunately , HBIG was inadvertently omitted from the immunisation schedule of this infant . ) Transmission rates were 4/138 ( 3 % ) from HBV DNA-positive mothers overall , 4/61 ( 7 % ) from HBeAg-positive mothers , and 4/47 ( 9 % ) from mothers with very high HBV DNA levels . No transmission was seen in 91 babies of mothers with HBV DNA levels < 10(8 ) copies/mL. CONCLUSION In this cohort , HBV perinatal transmission was restricted to HBeAg-positive mothers with very high viral loads OBJECTIVE To investigate the efficacy of telbivudine on intrauterine hepatitis B virus ( HBV ) infection during the last stage of pregnancy . METHODS 61 pregnant chronic hepatitis B ( CHB ) patients were enrolled and 31 patients were treated by telbivudine 600 mg once daily , 30 patients in the control group were not received antiviral treatment . Maternal HBV DNA level and the HBsAg positive rate in newborns were investigated . RESULTS The levels of serum HBV DNA in patients treated with Telbivudine were significantly reduced ( t = 19.09 , P less than 0.01 ) . Compared with the control group , serum HBV DNA levels were significantly lower in telbivudine treated patients than those in the control group before parturition ( t = 23.64 , P less than 0.01 ) . The infection rate of 7-month newborns were 0 and 13.33 % ( 4/30 ) , in telbivudine group and control group , respectively ( x2 = 4.29 , probability value less than 0.05 ) . CONCLUSIONS Telbivudine treatment can block intrauterine infection in pregnant chronic hepatitis B patients OBJECTIVE To investigate the effect of high viral loads ( HBV DNA concentration in blood > 2.0 copy/ml ) on the vertical transmission of hepatitis B virus in mothers with HBV DNA positivity . METHOD Forty pregnant women with HBV DNA positivity were divided r and omly , double-blindly into 2 groups : at 28 weeks of pregnancy , one group received oral lamivudine ( 100 mg/d ) and the other received oral placebo . The serum HBV DNA loads were tested at 28 and 40 weeks ' gestation in mothers , and serum HBV DNA , HBsAg , HBeAg and anti-HBs were examined in infants at 12 month follow up . RESULT Thirty-nine infants finished ( one twins ) the follow up , and 2 infants lost ( 5 % ) . Among them 4 infants were confirmed to be HBV infection ( 10 % , 4/39 ) , 2 in the treatment group ( 10 % , 2/20 ) and 2 in the control group ( 11 % , 2/19 ) ( P > 0.05 ) . The serum HBV DNA levels of 40 weeks ' gestation in the treatment group , compared with the levels of 28 weeks ' gestation in the treatment group and 40 weeks ' gestation in the control group , showed a significant decline ( P < 0.01 ) . The HBV DNA levels of the mothers whose infants were infected , were ( 3.1 + /- 3.4 ) copy/ml , ( 3.1 + /- 3.2 ) copy/ml during 28 and 40 weeks ' gestation , and for mothers whose infants were non-infected , the levels were ( 3.4 + /- 2.2 ) copy/ml , ( 2.6 + /- 1 . 5 ) copy/ml respectively ( P > 0.05 ) . The mean values of anti-HBs of 18 infants in the treatment group showed no significant difference as compared to 17 infants in the control group , ( 594 + /- 416 ) U/L vs ( 458 + /- 398 ) U/L ( P > 0.05 ) . CONCLUSION The pregnant women 's HBV DNA loads could be obviously decreased from high viral loads ( HBV DNA concentrations in blood > 2.0 copy/ml ) after they take lamivudine from 36 weeks ' gestation . But it might not reduce the maternal-fetal vertical transmission of HBV infection Little observational data exist describing telbivudine ( LdT ) or lamivudine ( LAM ) use in late pregnancy for preventing hepatitis B mother-to-child transmission ( MTCT ) in real-world setting s. During the period of January 2009 to March 2011 , we enrolled hepatitis B e antigen – positive mothers with HBV DNA > 6 log10 copies/mL in China . At gestation week 28 , the mothers received LdT or LAM until postpartum week 4 or no treatment ( NTx ) . The study endpoints were the safety of LdT/LAM use and MTCT rates . Of the 700 mothers enrolled , 648 ( LdT/LAM/NTx = 252/51/345 ) completed the 52-week study with 661 infants ( LdT/LAM/NTx = 257/52/352 ) . On treatment , viral rebound occurred in 1.6 % of mothers , all result ing from medication noncompliance . There was no genotypic mutation detected . At delivery , significantly lower HBV DNA levels were noted in mothers who received LdT or LAM versus NTx . Alanine aminotransferase flares were observed in 17.1 % of treated mothers versus 6.3 % of untreated mothers ( P < 0.001 ) . At birth , hepatitis B surface antigen ( HBsAg ) was detected in 20 % and
Output:
| No significant differences were found in the congenital malformation rate , prematurity rate , and Apgar scores .
Compared to control , lamivudine or telbivudine improved maternal HBV DNA suppression at delivery and during 4 - 8 weeks ' postpartum follow-up .
Tenofovir showed improvement in HBV DNA suppression at delivery .
No significant differences were found in postpartum hemorrhage , cesarean section , and elevated creatinine kinase rates .
CONCLUSIONS Antiviral therapy improves HBV suppression and reduces MTCT in women with chronic HBV infection with high viral load compared to the use of hepatitis B immunoglobulin and vaccination alone ; the use of telbivudine , lamivudine , and tenofovir appears to be safe in pregnancy with no increased adverse maternal or fetal outcome |
MS213435 | ***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 survey the management of acute Achilles tendon ruptures in the United Kingdom . Methods . A question naire with 4 different Achilles tendon rupture scenarios affecting patients of different ages and activity levels was sent to orthopaedic consultants specialised in sports trauma , foot and ankle surgery . Their treatment methods including surgical techniques , immobilisation and rehabilitation regimens were surveyed . Results . The response rate was 22 % ( 51/231 ) . Among the 51 respondents , 25 had managed less than 6 such patients in the preceding year . 26 ( 51 % ) used clinical examination ( e.g. calf squeeze test ) to make the diagnosis , 16 ( 31 % ) used ultrasonography , and 4 ( 8 % ) used magnetic resonance imaging . Surgical management was preferred for younger and more functionally dem and ing individuals . Open repairs were used more often than percutaneous repairs ( 72 vs 19 % ) . Across the 4 scenarios , the mean time to return to full activity was 17 ( range , 12–32 ) weeks for conservative to 19 ( range , 10–40 ) weeks for surgical management . Conclusion . Variation in opinion among respondents was wide . R and omised controlled trials are needed to assess optimal treatment BACKGROUND The treatment of Achilles tendon rupture has been controversial , and attempts are made to attenuate the complications arising from invasive procedures with minimally invasive techniques . This paper is a comparison between the results of Lynn 's traditional open technique and those of minimally invasive surgery assisted with the Achillon instrument guide . MATERIAL AND METHODS A prospect i ve , r and omized study was carried out in fifty-six patients with acute rupture of the Achilles tendon . Twenty-eight of them underwent surgery with Lynn 's technique and 28 underwent minimally-invasive surgery assisted with a mechanical guide . Patients were assessed at postoperative weeks 4 , 6 , 8 , 10 and 16 . They were examined for pain , muscle strength , presence or absence of Thomas sign , Merkel scale , ranges of motion , degree of amyotrophy , time to healing , degree of functional recovery , and complications . Data analysis was done with central trend measurements and nonparametric analyses . RESULTS The following were reported for Lynn 's technique ( LT ) and the minimally invasive approach ( MI ) : Mobility in extension : ( LT ) 40.3 + /- 0.59 degrees vs. ( MI ) 50.0 + /- 0.42 ( p < 0.01 ) ; flexion : ( LT ) 13.9 + /- 0.12 degrees vs. ( MI ) 18.2 + /- 18.2 degrees ( p < 0.01 ) ; amyotrophy : ( LT ) 2.9 + /- 0.09 cm vs. ( MI ) 1.5 + /- 0.13 ( p < 0.01 ) ; time to healing : ( LT ) 9.0 + /- 0.13 vs. ( MI ) 6.1 + /- 0.09 weeks ( p = 0.01 ) ; return to work : ( LT ) 9 weeks vs. ( MI ) 6 weeks . Postoperative complications were 19 for LT and 1 for MI . CONCLUSIONS The MI approach had statistically significant advantages over Lynn 's technique , which we attribute to a lesser tissue and neurovascular trauma OBJECTIVE Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assessment Question naire [ OQAQ ] ) ; ( 2 ) Sacks ' instrument ; and ( 3 ) our newly developed measurement tool ( AMSTAR ) . We report on reliability ( interobserver kappas of the 11 AMSTAR items ) , intraclass correlation coefficients ( ICCs ) of the sum scores , construct validity ( ICCs of the sum scores of AMSTAR compared with those of other instruments ) , and completion times . RESULTS The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 ( 95 % confidence interval [ CI ] : 0.57 , 0.83 ) ( range : 0.38 - 1.0 ) . Kappas recorded for the other instruments were 0.63 ( 95 % CI : 0.38 , 0.78 ) for enhanced OQAQ and 0.40 ( 95 % CI : 0.29 , 0.50 ) for the Sacks ' instrument . The ICC of the total score for AMSTAR was 0.84 ( 95 % CI : 0.65 , 0.92 ) compared with 0.91 ( 95 % CI : 0.82 , 0.96 ) for OQAQ and 0.86 ( 95 % CI : 0.71 , 0.94 ) for the Sacks ' instrument . AMSTAR proved easy to apply , each review taking about 15 minutes to complete . CONCLUSIONS AMSTAR has good agreement , reliability , construct validity , and feasibility . These findings need confirmation by a broader range of assessors and a more diverse range of review BACKGROUND We prospect ively analyzed and compared the functional and clinical results of patients with st and ard open and minimally invasive repair with the Achillon suture system at mid-term followup . MATERIAL S AND METHODS From February 2004 to May 2007 , 40 consecutive patients were operated for the treatment of acute Achilles tendon rupture with two different methods . None of the cases required adjunctive procedures like plantaris , flexor hallucis longus or gastrocnemius augmentation ( Lindholm , Bosworth ) to allow for acceptable end to end apposition . The patients were divided equally into two groups . In Group 1 , only Krakow end-to-end suturing technique and in Group 2 , Minimal invasive repair with Achillon suture system ( Integra Life Sciences Corporation , Plainsboro , NJ ) was used respectively . The average age of the patients was 40 years . Patients in study groups were followed up at mean of 22.4 ( range , 10 to 48 ) months after surgery . At the end of the followup time , functional outcome scores and complications were evaluated . RESULTS The AOFAS hindfoot clinical outcome scores were 98.7 in Group 1 , 96.8 in Group 2 . Although there was a numerical increase in AOFAS Scores in Group 1 , there was no significant difference . The surgical outcome concerning local tenderness , skin adhesions , scar and tendon thickness was better in Group 2 than in Group 1 with statistical significance . CONCLUSION Although functional outcomes of both treatment groups were the same , minimally invasive repair with the Achillon suture system provided safe , reliable and practical treatment with low risk of complications in the treatment of acute Achilles tendon ruptures The object of this study was to compare treatment of ruptured Achilles tendon by operative " end to end " surgery , percutaneous repair , or conservative therapy clinical ly ; a subject of considerable controversy in the literature . These three methods were compared in 73 patients in a r and omized trial between 1994 and 1996 . After 2.5 years ( 11 - 41 months ) , the actual activities were assigned to the Hannover Achilles tendon score and the ability of doing work or sport activities was assessed . After this period , 59.3 % of the patients showed good and excellent results on the Achilles tendon score , with over 79 points ( open surgery 59.1 % , percutaneous 60 % , conservative treatment 58.3 % ) . None of the patients reached the maximum score of 100 points . During the isometric strength tests , the patients with percutaneous repair had a lower weakening of the treated leg ( 8.9 % ) compared to the open-operated ( 12.7 % ) and non-operated patients ( 17.8 % ) . Of the patients who had percutaneous surgery , 88 % rated their treatment as good or excellent ; those who had open surgery 77.3 % , and those with conservative treatment 75 % . The percutaneous group were able to resume work and sport much sooner than the other two groups . Bearing in mind the literature and these results , we have developed an algorithm for treating Achilles tendon rupture to assist decision making in daily routine . In this way , the use of percutaneous Achilles tendon repair can be carried out in most of cases A prospect i ve r and omized controlled trial comparing open and percutaneous repair of closed ruptured Achilles tendons was performed over a period of 30 months . Sixty-six patients from seven district general hospitals were entered into the study with 33 patients r and omized into each group . A modification of the technique described by Ma and Griffith was used in the percutaneous group and a Kessler suture supplemented with interrupted sutures was used in the open group . Patients were followed up for a minimum of six months . The mean age was 38.5 years ( 26 to 53 years ) . Forty patients were male and 26 female . After the rupturing event but prior to surgery , it was noted that seven patients had paresthesia in the territory of the sural nerve . The mean duration of immobilization was 12.4 weeks ( 10 to 14 ) . The complications in the open group included seven wound infections ( 21 % ) , two adhesions ( 6 % ) and two cases of re-rupture ( 6 % ) . In the percutaneous group there were three cases of wound puckering ( 9 % ) , one re-rupture ( 3 % ) and one case with persistent paresthesia in the sural nerve territory ( 3 % ) . The difference in infective wound complications between the two groups was statistically significant ( Fisher 's exact test P = 0.01 ) . Percutaneous repair is advocated on the basis of the low rate of complications and improved cosmetic appearance Purpose To study the effects of early weightbearing and ankle mobilization after acute repair of ruptured Achilles tendon . Study Design Comparative longitudinal study . Methods Patients in group 1 were postoperatively immobilized with their ankle in gravity equinus , they were encouraged to bear weight on the operated limb as soon as possible to full weightbearing , and they received a single cast change at 2 weeks , with the ankle accommo date d in an anterior splint in a planti grade position , allowing the ankle to be plantar flexed fully but not dorsiflexed above neutral . Patients in group 2 were immobilized with their ankle in full equinus with a cast change at 2 weeks , when the ankle was immobilized in mid equinus , and at 4 weeks , when the ankle was immobilized in a planti grade position , and they were advised to bear weight . Results Patients in group 1 attended fewer outpatient visits , completely discarded their crutches at an average of 2.5 weeks , and more were satisfied with the results of surgery . At ultrasonography , the average thickness of the repaired tendon was 12.1 mm , with no difference in the thickness of the ruptured tendon regardless of postoperative management . There was no significant difference in isometric strength between the two groups . Conclusions Early weightbearing with the ankle planti grade is not detrimental to the outcome of repair after acute rupture of the Achilles tendon and shortens the time needed for rehabilitation . However , strength deficit and muscle atrophy are not prevented There is no agreement on the ideal type of surgical management for Achilles tendon rupture . The present r and omized prospect i ve study was performed to compare outcome data of open and percutaneous repair in the treatment of Achilles tendon rupture . Forty consecutive patients with acute rupture of Achilles tendon were recruited . Patients were r and omized to receive open ( group A ) or percutaneous repair with Tenolig ® ( group B ) . All patients followed the same rehabilitation protocol except for slight differences in the duration of immobilization . Follow-up included objective evaluation ( at 4 and 12 months ) , subjective evaluation using the SF-12 ® question naire ( at 24 months ) , and bilateral ultrasound scanning and isokinetic testing ( at 12 months ) . The differences in the parameters evaluated clinical ly were not significant except for ankle circumference , which was significantly greater in group B. There were two minor complications in the open repair group and one case of failed repair in the percutaneous group . SF-12 ® question naire , ultrasound and isokinetic test data did not show significant differences between the groups . The present study demonstrates that the open and the percutaneous technique are both safe and effective in repairing the ruptured Achilles tendon and that both afford the same degree of restoration of clinical , ultrasound and isokinetic patterns . Medium-term results were substantially comparable . Percutaneous repair is performed on a day-surgery basis , it reduces cutaneous complications and operation times , and enables faster recovery , enhancing overall patient compliance . To us , these characteristics make it preferable to open repair in managing subcutaneous ruptures of Achilles tendon in non-professional sports practicing adults Orthopaedic surgeons have always based their clinical care on evidence . Surgeons use evidence to make decisions tailored to an individual patient 's needs and circumstances . The primary sources of evidence for clinicians are studies published in the medical and surgical literature , such as The Journal of Bone and Joint Surgery . In June 2000 , The Journal introduced the quarterly Evidence -Based Orthopaedics section 1 . This section introduces orthopaedic surgeons to recent r and omized trials relevant to the practice of orthopaedic surgery published in forty-two journals
Output:
| A high- quality meta- analysis with more RCTs was chosen , which suggested that there was no statistically significant difference between MIS and OS regarding rerupture rate , tissue adhesion , sural nerve injury , deep infection , and deep vein thrombosis .
However , MIS could decrease superficial infection rate , and had a better patient satisfaction for good to excellent outcomes in comparison to OS .
Conclusions Based on the best available evidence , MIS may be superior to OS for treating acute Achilles tendon rupture . |
MS213436 | ***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 R and omised controlled trials demonstrate a 60 % reduction in type 2 diabetes incidence through lifestyle modification programmes . The aim of this study is to determine whether such programmes are feasible in primary health care . Methods An intervention study including 237 individuals 40–75 years of age with moderate or high risk of developing type 2 diabetes . A structured group programme with six 90 minute sessions delivered during an eight month period by trained nurses in Australian primary health care in 2004–2006 . Main outcome measures taken at baseline , three , and 12 months included weight , height , waist circumference , fasting plasma glucose and lipids , plasma glucose two hours after oral glucose challenge , blood pressure , measures of psychological distress and general health outcomes . To test differences between baseline and follow-up , paired t-tests and Wilcoxon rank sum tests were performed . Results At twelve months participants ' mean weight reduced by 2.52 kg ( 95 % confidence interval 1.85 to 3.19 ) and waist circumference by 4.17 cm ( 3.48 to 4.87 ) . Mean fasting glucose reduced by 0.14 mmol/l ( 0.07 to 0.20 ) , plasma glucose two hours after oral glucose challenge by 0.58 mmol/l ( 0.36 to 0.79 ) , total cholesterol by 0.29 mmol/l ( 0.18 to 0.40 ) , low density lipoprotein cholesterol by 0.25 mmol/l ( 0.16 to 0.34 ) , triglycerides by 0.15 mmol/l ( 0.05 to 0.24 ) and diastolic blood pressure by 2.14 mmHg ( 0.94 to 3.33 ) . Significant improvements were also found in most psychological measures . Conclusion This study provides evidence that a type 2 diabetes prevention programme using lifestyle intervention is feasible in primary health care setting s , with reductions in risk factors approaching those observed in clinical trials . Trial NumberCurrent Controlled Trials IS RCT Background Rising levels of obesity coupled with the limited success of currently available weight control methods highlight the need for investigation of novel approaches to obesity treatment . This study aims to determine the effectiveness and cost-effectiveness of an Internet-based re source for obesity management . Methods A r and omised controlled trial conducted in a community setting , where obese volunteers ( n = 221 ) were r and omly assigned to Internet group ( n = 111 ) or usual care group ( n = 110 ) . Objective measures of weight and height were obtained . Question naires were used to collect dietary , lifestyle , physical activity and quality of life data . Data were collected at baseline , six months and 12 months . Results Data were collected on 54 ( 49 % ) participants in the Internet group and 77 ( 70 % ) participants in the usual care group at 12 months . Based on analysis conducted on all available data , the Internet group lost 1.3 kg , compared with 1.9 kg weight loss in the usual care group at 12 months , a non-significant difference ( difference = 0.6 kg ; 95 % CI : -1.4 to 2.5 , p = 0.56 ) . No significant differences in change in secondary outcome measures between the two groups at six or 12 months were revealed . Total costs per person per year were higher in the Internet group than the usual care group ( £ 992.40 compared to £ 276.12 ) , primarily due to the fixed costs associated with setting up the website , and QALYs were similar ( 0.78 and 0.77 ) for both groups . Conclusion This trial failed to show any additional benefit of this website in terms of weight loss or secondary outcome measures compared with usual care . High attrition and low compliance limits the results of this research . The results suggest that the Internet-based weight control re source was not a cost-effective tool for weight loss in the obese sample studied . Trail Registration IS RCT N Background : Research on the translation of efficacious lifestyle change programs to prevent type 2 diabetes into community or clinical setting s is needed . Objective : The objective of this study was to examine the reach , implementation , and efficacy of a 6-month lifestyle program implemented in primary care by nurse practitioners ( NPs ) for adults at risk of type 2 diabetes . Methods : The NP sites ( n = 4 ) were r and omized to an enhanced st and ard care program ( one NP and one nutrition session ) or a lifestyle program ( enhanced st and ard care and six NP sessions ) . These NPs recruited adults at risk of diabetes from their practice ( n = 58 ) , with an acceptance rate of 70 % . Results : The program reached a diverse , obese , and moderately low income sample . The NPs were able to successfully implement the protocol s. The average length of the program was 9.3 months . Attendance was high ( 98 % ) , and attrition was low ( 12 % ) . The NPs were able to adopt the educational , behavioral , and psychosocial strategies of the intervention easily . Motivational interviewing was more difficult for NPs . Mixed-model repeated- measures analysis indicated significant trends or improvement in both groups for nutrition and exercise behavior . Participants of the lifestyle program demonstrated trends for better high-density lipoprotein ( HDL ) and exercise behavior compared with the enhanced st and ard care participants . Twenty-five percent of lifestyle participants met treatment goals of 5 % weight loss compared with 11 % of st and ard care participants . Discussion : A lifestyle program can be implemented in primary care by NPs , reach the targeted population , and be modestly successful . Further research is indicated OBJECTIVE To measure the level of functional health literacy ( FHL ) in an Australian population , and to explore the level of risk associated with level of FHL . DESIGN , SETTING AND PARTICIPANTS Cross-sectional , r and om population survey administered to 2824 South Australians aged > or=15 years , September-October 2008 . MAIN OUTCOME MEASURES Newest Vital Sign as a measure of FHL , self-reported general health status , and use of health services . RESULTS 24 % of respondents were at risk of limited FHL , and 21 % had a high likelihood of inadequate FHL ; this increased with age ( > or=65 years , 50 % v 25 - 44 years , 11 % ) . In multiple logistic regression models , a high likelihood of inadequate FHL was significantly more common among those with lower education ( left school < or=15 years of age , odds ratio [ OR ] , 8.1 ; 95 % CI , 4.8 - 13.6 ) ; with lower annual income ( < $ 20 000 , OR , 4.1 ; 95 % CI , 2.3 - 7.4 ) ; who were born in countries other than Australia , New Zeal and , the United Kingdom and Irel and ; and with poorer health status ( OR , 1.6 ; 95 % CI , 1.2 - 2.2 ) . Inadequate FHL was significantly less common among females ( OR , 0.6 ; 95 % CI , 0.5 - 0.8 ) . People with inadequate or at-risk FHL were significantly more likely to report having diabetes , cardiac disease or stroke , and significantly less likely to have recently attended a doctor . Respondents aged > or=65 years with inadequate FHL were more likely to have been admitted to hospital ( OR , 2.2 ; 95 % CI , 1.1 - 4.5 ) . CONCLUSION Many Australians are likely to have limited health literacy , and this is a risk to effective health care delivery and health improvement across the community Most primary care providers ( PCPs ) , constrained by time and re sources , can not provide intensive behavioral counseling for obesity . This study evaluated the effect of using medical assistants ( MAs ) as weight loss counselors . The study was a r and omized controlled trial conducted in two primary care offices at an academic medical center . Patients ( n = 50 ) had a BMI of 27 - 50 kg/m(2 ) and no contraindications to weight loss . They were r and omized to quarterly PCP visits and weight loss material s ( Control group ) or to the same approach combined with eight visits with a MA over 6 months ( Brief Counseling ) . Outcomes included change in weight and cardiovascular risk factors ( glucose , lipids , blood pressure , and waist circumference ) . Patients in the Brief Counseling and Control groups lost 4.4 + /- 0.6 kg ( 5.1 + /- 0.7 % of initial weight ) and 0.9 + /- 0.6 kg ( 1.0 + /- 0.7 % ) , respectively , at month 6 ( P < 0.001 ) . There were no significant differences between groups for changes in cardiovascular risk factors . Brief Counseling patients regained weight between month 6 and month 12 , when MA visits were discontinued . Attrition was 10 % after 6 months and 6 % after 12 months . Brief Counseling by MAs induced significant weight loss during 6 months . Office-based obesity treatment should be tested in larger trials and should include weight loss maintenance counseling BACKGROUND The impact of overweight and nonmorbid obesity on health-related quality of life ( HRQL ) has not been widely research ed . The aim of this study was to evaluate the effects of a lifestyle modification program ( LMP ) focused on diet , exercise , and psychological support on HRQL in overweight and nonmorbidly obese patients treated in a primary healthcare setting . METHODS Sixty patients with grade II overweight and nonmorbid grade I-II obesity were included in this open pilot clinical trial ; subjects ' ages ranged from 18 to 50 years . They were provided with an LMP combining nutrition education , physical activity , and psychological support . Subjects attended group sessions every 2 weeks . The main outcome measures at baseline and 6 months were body composition parameters ( body mass index , body fat percentage , and waist circumference ) and HRQL using the 1.4 Spanish version of the SF-36 question naire . The question naire yields an 8-scale profile of physical functioning ( PF ) , role -- physical ( RP ) , bodily pain ( BP ) , vitality ( VT ) , social functioning ( SF ) , role -- emotional ( RE ) , mental health ( MH ) , and general health ( GH ) factors . RESULTS The LMP achieved improvements in SF-36 subscales at the end of the intervention : PF ( 80.37 ± 18.90 vs 89.40 ± 13.95 , P < .001 ) , RP ( 20.37 ± 9.10 vs 23.14 ± 6.67 , P < .05 ) , VT ( 58.71 ± 21.98 vs 70.91 ± 26.56 , P < .01 ) , SF ( 79.62 ± 27.76 vs 86.57 ± 25.45 , P < .03 ) , and GH ( 61.03 ± 19.13 vs 69.42 ± 18.80 , P < .001 ) . CONCLUSION An LMP focused on balanced and moderate energy-restricted diets , increased physical activity , and psychological support may improve the anthropometric parameters and the quality of life in moderately obese patients treated in a primary healthcare center BACKGROUND Around 10 - 15 % of adults aged over 40 years have pre-diabetes , which carries a high risk of progression to type 2 diabetes . Intensive lifestyle intervention reduces progression by as much as 58 % . However , the cost and personnel requirements of these interventions are major obstacles to delivery in NHS primary care . AIM To assess the effectiveness of a low-cost intervention , delivered in primary care by non-NHS staff , to reduce the risk of diabetes through weight loss and physical activity . DESIGN OF STUDY Pragmatic single-blind r and omised controlled trial with research ers and statistician blinded to group allocation . SETTING UK primary care . METHOD One-hundred and forty-one participants with a body mass index of 28 kg/m2 or more , but without diabetes or heart disease , received either information leaflets or individual behavioural counselling using motivational interviewing techniques . The intervention was delivered by five counsellors recruited from the local community . The primary outcomes were the proportions of participants meeting predefined targets for weight loss ( 5 % ) and moderate physical activity ( 150 minutes/week ) after 6 months . RESULTS Using intention-to-treat analysis , more people in the intervention group achieved the weight-loss target ( 24 % versus 7 % for controls ; odds ratio [OR]=3.96 ; 95 % confidence interval [Cl]=1.4 to 11.4 ; number needed to treat [NNT]=6.1 ( 95 % Cl=4 to 21 ) . The proportion achieving the physical activity target did not increase significantly ( 38 % versus 28 % for controls ; OR=1.6 ; 95 % Cl=0.7 to 3.8 ) . CONCLUSION Short-term weight loss , at a level which , if sustained , is clinical ly meaningful for reducing diabetes risk , is achievable in primary care , without excessive use of NHS monetary or personnel re sources
Output:
| There were no consistent associations in outcomes related to the mode of intervention delivery , the number or type of providers involved or the intensity of the intervention .
Conclusions There was evidence for the effectiveness of interventions that focussed on improving knowledge and skills ( health literacy ) for weight loss .
However , there was insufficient evidence to determine relative effectiveness of individual interventions . |
MS213437 | ***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 Perioperative anemia leads to increased morbidity and mortality and potentially inhibits rehabilitation after hip fracture surgery . As such , the optimum transfusion threshold after hip fracture surgery is unknown . PATIENTS AND METHODS A total of 120 elderly , cognitively intact hip fracture patients admitted from their own home were r and omly assigned to receive transfusion at a hemoglobin threshold of 10.0 g per dL ( liberal ) versus 8.0 g per dL ( restrictive ) in the entire perioperative period . Patients were treated according to a well-defined multimodal rehabilitation program . Primary outcome was postoperative functional mobility measured with the cumulated ambulation score ( CAS ) . RESULTS Patients in the liberal group received transfusions more frequently than those in the restrictive group ( 44 patients vs. 22 patients ; p < 0.01 ) and received more transfusions during hospitalization ( median , 2 units [ interquartile range , 1 - 2 ] vs. 1 [ 1 - 2 ] ; p < 0.0001 ) . There were no significant differences in postoperative rehabilitation scores ( CAS : median , 9 [ 9 - 15 ] vs. 9 [ 9 - 13.5 ] ; p = 0.46 ) or in length of stay ( median , 18 days vs. 16 days , respectively ; p = 0.46 ) . There were fewer patients in the liberal transfusion group with cardiovascular complications ( 2 % vs. 10 % ; p = 0.05 ) and a lower mortality ( 0 % vs. 8 % ; p = 0.02 ) . CONCLUSION Although a liberal transfusion trigger did not result in increased ambulation scores , restrictive transfusion thresholds should be treated with caution in elderly high-risk hip fracture patients , until their safety has been proved in larger r and omized studies Objective : To determine the effect of admission hemoglobin level on patient outcome after hip fracture . Study Design : Prospect i ve , consecutive . Patients : From July 1991 to June 1997 , 395 communitydwelling patients sixty‐five years of age or older who had sustained an operatively treated femoral neck or intertrochanteric fracture were prospect ively followed up . Main Outcome Measurements : Postoperative complications , in‐hospital mortality rate , hospital length of stay , hospital discharge status , place of residence at one year , and mortality and recovery of ambulatory ability and activities of daily living status at three , six , and twelve months . Results : Women with admission hemoglobin levels below 12.0 grams per deciliter and men with admission hemoglobin levels below 13.0 grams per deciliter were classified as anemic . One hundred eighty patients ( 45.6 percent ) were considered anemic on admission . Patients who were anemic were more likely to have an American Society of Anesthesiologists rating of III or IV and have sustained an intertrochanteric fracture . Hospital length of stay and mortality rate at six and twelve months were significantly higher for patients who were anemic on admission . There were no differences in the incidence of postoperative complications , hospital discharge status , place of residence at one year , in‐hospital mortality rate , and three‐month mortality rate between patients who were and were not anemic on admission . In addition , there were no differences in the recovery of ambulatory ability and of basic and instrumental activities of daily living status at three , six , and twelve months between the two patient groups . Conclusions : Patients at risk for poor outcomes after hip fracture can be identified by assessing hemoglobin levels at hospital admission Background Anemia is more often seen in older patients . As the mean age of hip fracture patients is rising , anemia is common in this population . Allogeneic blood transfusion ( ABT ) and anemia have been pointed out as possible risk factors for poorer outcome in hip fracture patients . Methods In the timeframe 2005 - 2010 , 1262 admissions for surgical treatment of a hip fracture in patients aged 65 years and older were recorded . Registration was prospect i ve from 2008 on . Anemic and non-anemic patients ( based on hemoglobin level at admission ) were compared regarding clinical characteristics , mortality , delirium incidence , LOS , discharge to a nursing home and the 90-day readmission rate . Receiving an ABT , age , gender , ASA classification , type of fracture and anesthesia were used as possible confounders in multivariable regression analysis . Results The prevalence of anemia and the rate of ABT both were 42.5 % . Anemic patients were more likely to be older and men and had more often a trochanteric fracture , a higher ASA score and received more often an ABT . In univariate analysis , the 3- and 12-month mortality rate , delirium incidence and discharge to a nursing home rate were significantly worse in preoperatively anemic patients .In multivariable regression analysis , anemia at admission was a significant risk factor for discharge to a nursing home and readmission < 90 days , but not for mortality . Indication for ABT , age and ASA classification were independent risk factors for mortality at all moments , only the mortality rate for the 3 - 12 month interval was not influenced by ABT . An indication for an ABT was the largest negative contributor to a longer LOS ( OR 2.26 , 95 % CI 1.73 - 2.94 ) and the second largest for delirium ( OR 1.67 , 95 % CI 1.28 - 2.20 ) . Conclusions This study has demonstrated that anemia at admission and postoperative anemia needing an ABT ( PANT ) were independent risk factors for worse outcome in hip fracture patients . In multivariable regression analysis , anemia as such had no effect on mortality , due to a rescue effect of PANT . In-hospital , 3- and 12-month mortality was negatively affected by PANT , with the main effect in the first 3 months postoperatively BACKGROUND Patients undergoing pertrochanteric hip fracture ( PHF ) repair surgery often receive perioperative allogeneic blood transfusions ( ABTs ) to avoid the deleterious effects of anemia . Nevertheless , concerns about adverse effects of ABTs have prompted the review of transfusion practice and the search for a safer treatment of perioperative anemia . MATERIAL AND METHODS The effect of preoperative 200 to 300 mg of intravenous ( IV ; Group 2 ; n = 55 ) iron sucrose administration on transfusion requirements and postoperative morbidity-mortality in patients with PHF has been prospect ively investigated . A previous series of 102 PHF patients served as the control group ( Group 1 ) . All patients were older than 65 years and were operated on at the third day after admission to the hospital , by the same medical team and with the same implant . RESULTS Iron sucrose was well tolerated and reduced the transfusion rate in patients with admission hemoglobin levels of greater than 120 g per L ( p < 0.05 ) who also received fewer units of red blood cells ( p < 0.05 ) . In addition , iron sucrose reduced postoperative infection rate ( p < 0.05 ) , but not 30-day mortality rate or mean length of hospital stay . CONCLUSION The administration of IV iron sucrose seems to reduce ABT requirements in patients with PHF and is associated to lower postoperative morbidity . The possible mechanisms involved in these effects are discussed BACKGROUND Retrospective studies suggest that preoperative anaemia is associated with poor outcomes after surgery . The objective of this study was to describe mortality rates and patterns of intensive care re source use for patients with anaemia undergoing non-cardiac and non-neurological in-patient surgery . METHODS We performed a secondary analysis of a large prospect i ve study describing perioperative care and survival in 28 European nations . Patients at least 16 yr old undergoing in-patient surgery during a 7 day period were included in the study . Data were collected for in-hospital mortality , duration of hospital stay , admission to intensive care , and intensive care re source use . Multivariable logistic regression analysis was performed to underst and the effects of preoperative haemoglobin ( Hb ) levels on in-hospital mortality . RESULTS We included 39 309 patients in the analysis . Preoperative anaemia had a high prevalence in both men and women ( 31.1 % and 26.5 % , respectively ) . Multivariate analysis showed that patients with severe [ odds ratio 2.82 ( 95 % confidence interval 2.06 - 3.85 ) ] or moderate [ 1.99 ( 1.67 - 2.37 ) ] anaemia had higher in-hospital mortality than those with normal preoperative Hb concentrations . Furthermore , hospital length of stay ( P<0.001 ) and postoperative admission to intensive care ( P<0.001 ) were greater in patients with anaemia than in those with normal Hb concentrations . CONCLUSIONS Anaemia is common among non-cardiac and non-neurological surgical patients , and is associated with poor clinical outcome and increased healthcare re source use . CLINICAL TRIAL REGISTRATION NCT01203605 ( Clinical Trials.gov ) Context : Pharmacological agents are used to reduce postoperative blood loss . Aims : To assess the effects of tranexamic acid on prevention of bleeding and requirement of blood transfusion after major hip and femoral surgeries . Setting s and Design : A prospect i ve , r and omized , double blinded study was conducted in the tertiary care teaching hospital . Methods : Ninety ASA grade I-II patients undergoing hip fracture surgery were included in this prospect i ve study . Forty-five patients received tranexamic acid ( TA ) given in a bolus dose of 500 mg 15 min before surgical incision followed by continuous infusion . The remaining , 45 patients were allocated as a control group . Postoperative bleeding ( volume of blood in the drain ) , percentage fall of hemoglobin , transfusions and complications were recorded . Results : Mean volume of blood in the drain was 39.33±10.09 ml ( mean±SD ) as compared to 91.11±17.61 ml in placebo group showing a P<0.001 . Mean percentage fall in Hb at day 0 was 2.99±3.45 in the study group as compared to 7.70±6.05 in the placebo group ( P<0.001 ) , and fall at day 2 in the study group was 0.35±0.74 , compared to 2.72±2.70 in the placebo group ( P<0.001 ) . The number of patients required blood transfusions were lower in the study group than in the placebo group ( P=0.01 ) . Conclusions : We conclude that tranexamic acid significantly reduces postoperative blood loss and transfusion requirements during major hip and femoral surgeries BACKGROUND The hemoglobin threshold at which postoperative red-cell transfusion is warranted is controversial . We conducted a r and omized trial to determine whether a higher threshold for blood transfusion would improve recovery in patients who had undergone surgery for hip fracture . METHODS We enrolled 2016 patients who were 50 years of age or older , who had either a history of or risk factors for cardiovascular disease , and whose hemoglobin level was below 10 g per deciliter after hip-fracture surgery . We r and omly assigned patients to a liberal transfusion strategy ( a hemoglobin threshold of 10 g per deciliter ) or a restrictive transfusion strategy ( symptoms of anemia or at physician discretion for a hemoglobin level of < 8 g per deciliter ) . The primary outcome was death or an inability to walk across a room without human assistance on 60-day follow-up . RESULTS A median of 2 units of red cells were transfused in the liberal- strategy group and none in the restrictive- strategy group . The rates of the primary outcome were 35.2 % in the liberal- strategy group and 34.7 % in the restrictive- strategy group ( odds ratio in the liberal- strategy group , 1.01 ; 95 % confidence interval [ CI ] , 0.84 to 1.22 ) , for an absolute risk difference of 0.5 percentage points ( 95 % CI , -3.7 to 4.7 ) . The rates of in-hospital acute coronary syndrome or death were 4.3 % and 5.2 % , respectively ( absolute risk difference , -0.9 % ; 99 % CI , -3.3 to 1.6 ) , and rates of death on 60-day follow-up were 7.6 % and 6.6 % , respectively ( absolute risk difference , 1.0 % ; 99 % CI , -1.9 to 4.0 ) . The rates of other complications were similar in the two groups . CONCLUSIONS A liberal transfusion strategy , as compared with a restrictive strategy , did not reduce rates of death or inability to walk independently on 60-day follow-up or reduce in-hospital morbidity in elderly patients at high cardiovascular risk . ( Funded by the National Heart , Lung , and Blood Institute ; FOCUS Clinical Trials.gov number , NCT00071032 . ) Background Around one third to one half of patients with hip fractures require red-cell pack transfusion . The increasing incidence of hip fracture has also raised the need for this scarce re source . Additionally , red-cell pack transfusions are not without complications which may involve excessive morbidity and mortality . This makes it necessary to develop blood-saving strategies . Our objective was to assess safety , efficacy , and cost-effictveness of combined treatment of i.
Output:
| Transfusion threshold was not associated with differences in other outcomes .
Studies for most interventions recruited too few participants to determine effects on infections , mortality or function |
MS213438 | ***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 Cryosurgical ablation of the prostate is a novel therapeutic modality that induces cell lysis in the prostate by direct application of low temperatures . We have been conducting an ongoing prospect i ve pilot study of the use of cryosurgical prostate ablation in treating patients with nonmetastatic prostate adenocarcinoma since January 1993 . Results in 145 consecutive patients with mean 36 months and minimum 12 months of followup are presented . MATERIAL S AND METHODS Accrual was open to patients with clinical stages T1a to T3c prostate adenocarcinoma . Pelvic lymph node dissections were recommended but not required for patients with prostate specific antigen ( PSA ) greater than 15 ng./ml . before study entry . PSA changes , r and om prostate biopsy findings and morbidities after cryosurgical prostate ablation were recorded for each patient . RESULTS Overall actuarial rates at 42 months for maintaining PSA less than 0.3 and less than 1.0 were 59 % and 66 % , respectively . The overall actuarial progression-free rate at 60 months was 56 % . Among 160 biopsies performed 16 % showed some evidence of residual carcinoma . Overall crude rates of maintaining either a negative biopsy or PSA less than 0.3 at 6 and 24 months after cryosurgical prostate ablation were 87 % and 73 % , respectively . Significantly higher morbidities were seen in previously radiated patients undergoing cryosurgical prostate ablation compared to those with no prior radiation . Among nonradiated patients 85 % experienced no significant morbidity after cryosurgical prostate ablation . CONCLUSIONS Although preliminary , short-term outcomes after cryosurgical prostate ablation appear to be comparable to identical outcomes reported for external beam radiotherapy . Based on these results cryosurgical prostate ablation appears to be an effective therapeutic alternative for treating patients with localized prostate adenocarcinoma PURPOSE A phase I/II study was done to evaluate the efficacy and complications of salvage cryotherapy as a treatment for locally recurrent prostate cancer following full dose radiation therapy and /or systemic therapy . The efficacy of single and double freeze-thaw cycles was compared using posttreatment prostate specific antigen ( PSA ) levels and prostate biopsies as end points . MATERIAL S AND METHODS A total of 150 patients with locally recurrent prostate cancer following radiation , hormonal therapy and /or systemic chemotherapy underwent salvage cryotherapy using a single ( 71 men , mean followup 17.3 months ) or double ( 79 men , mean followup 10.0 months ) freeze-thaw cycle . PSA was measured approximately every 3 months postoperatively and sextant biopsies were repeated 6 months postoperatively . Complications were assessed by retrospective chart review and a mailed quality of life survey . RESULTS Overall , 45 patients ( 31 % ) had persistently undetectable PSA . Patients with a history of radiation therapy only who underwent a double freeze-thaw cycle had a higher negative biopsy rate ( 93 versus 71 % , p < 0.02 ) and lower biochemical failure rate ( defined as an increase in serum PSA of 0.2 ng./ml . above the nadir value , 44 versus 65 % , p < 0.03 ) than those who underwent a single freeze-thaw cycle . The main complications of salvage cryotherapy were urinary incontinence ( 73 % of the patients ) , obstructive symptoms ( 67 % ) , impotence ( 72 % ) and severe perineal pain ( 8 % ) . CONCLUSIONS Salvage cryotherapy impacts local tumor control as evident by the high frequency of negative posttreatment biopsies . A double freeze-thaw cycle appears more effective than a single cycle . Like salvage prostatectomy , salvage cryotherapy causes significant morbidity PURPOSE We examined the role of percutaneous cryoablation of the prostate in the treatment of prostate cancer . MATERIAL S AND METHODS We performed 95 percutaneous cryoablations of the prostate on 87 patients with prostate cancer . Of the patients 6 had positive lymph nodes preoperatively , radiation failed in 9 and 9 began postoperative hormonal therapy because of treatment failure . Mean patient age , prostate specific antigen ( PSA ) level ( ng./ml . ) and Gleason score were 65.4 , 12.60 and 6.03 , respectively . Median followup was 12 months ( mean 9.3 , range 1 to 24 ) . In 49 of the 87 patients ( 56 % ) the lymph nodes were evaluated before cryoablation based on the treatment protocol . RESULTS Median PSA level at 12 months was 0.55 ng./ml . ( mean 1.73 ) with a 17 % positive biopsy rate at 3 months . When the positive lymph node , radiation failure and postoperative hormonal therapy groups were removed from analysis , the median PSA level was 0.80 ng./ml . ( mean 1.86 ) with a 5 % positive biopsy rate . Of the patients in the radiation failure group 37 % had a positive biopsy at 3 months . Cases were classified according to stage , grade and PSA level , and the biopsy results were presented . The complications of percutaneous cryoablation of the prostate were review ed . CONCLUSIONS The low percentage of positive biopsies is encouraging but the significance of the persistent PSA levels remains uncertain OBJECTIVES To describe and assess the efficacy for increased gl and ular destruction by using 6 to 8 cryoprobes in place of the traditional 5 probes . METHODS In April 1996 , a revised method for cryosurgery was begun that uses 6 to 8 cryoprobes , and by July 1997 , 81 men had been treated . This group was compared retrospectively to our last 82 cases done before April 1996 using 5 cryoprobes . All cases were consecutive . To ensure that the groups were similar , comparison was performed of entrance prostate-specific antigen ( PSA ) , clinical stage , and Gleason score . Six months after cryosurgery , PSA and residual epithelial acini were compared between the two groups . RESULTS The two groups were comparable for all the above parameters ( P > 0.05 ) . The degree of overall gl and ular kill was greater for the 6 to 8-probe method ( P = 0.023 ) . Complete gl and ular ablation for the 5-probe and 6 to 8-probe methods was 39 % and 53 % , respectively , and the difference was not significant ( P = 0.072 ) . However , when one combined the complete gl and ular ablation group with the none to few residual acini group , 67.5 % for the 5-probe method and 88.9 % for the 6 to 8-probe method , a significant difference was found ( P = 0.001 ) . The odds of having many remaining acini versus having none to few were 3.5 times greater in the 5-probe group than in the 6 to 8-probe group . The mean and median PSA for the 5- and 6 to 8-probe groups were 0.19 and 0.1 versus 0.11 and 0.07 ng/mL , respectively , a significant difference ( P = 0.02 ) . No difference was found in rates of tumor persistence or complications . CONCLUSIONS A revised method for cryosurgery using 6 to 8 cryoprobes has proved to be more effective for near-gl and ular ablation than the traditional 5-probe method . It was easily applied , had a wide margin of safety , and even shortened learning time . These innovations have permitted a closer approach to the goal of complete gl and ular destruction OBJECTIVES Percutaneous cryosurgical ablation of the prostate ( CSAP ) was performed on patients with localized or locally advanced adenocarcinoma of the prostate . To assess local disease control , post-treatment biopsy and serum prostate-specific antigen ( PSA ) levels were obtained at 3 and 24 months post-treatment . METHODS From June 1990 through May 1994 , CSAP was performed 448 times on 383 patients under Institutional Review Board protocol s. A urethral warming catheter was used for all procedures . A total of 239 patients were followed for a minimum of 21 months after treatment . None of this group had received prior local treatment . The group consisted of patients who were newly diagnosed and treated solely with cryotherapy ( virgin ) ; the remainder had been on and rogen deprivation therapy ( ADT ) prior to CSAP . RESULTS Biopsies were obtained from 114 patients at 21 months or more after treatment . In the virgin group , 79 % had a negative biopsy after one or more treatments , and 88 % of the ADT group are negative after one or more treatments . Overall , 69 % had a negative biopsy after one treatment and 82 % had a negative biopsy following one or more CSAP treatments . Of a group of 163 patients , PSA data were evaluable at 21 months or more after treatment . In the virgin group , 60 % had a PSA 0.4 ng/mL or less , and 77 % had a PSA 1.0 ng/mL or less . In the ADT group , 40 % had a PSA 0.4 ng/mL or less , and 69 % had a PSA value of 1.0 ng/m Lor less . Complications were minimal , the most common one being urethral tissue sloughing , which occurred in 10 % of patients . CONCLUSIONS CSAP appears to be effective in obtaining local control as measured by biopsy and PSA 21 months or more post-treatment . When retrospectively comparing our results with recently published radiotherapy series , CSAP was more effective in obtaining nadir PSA values 1.0 ng/mL or less and negative biopsies at 21 months or more after treatment OBJECTIVE To study the complications and oncological outcome after cryosurgical ablation of the prostate ( CSAP ) . METHODS Fifty-four patients with prostate cancer were entered into this prospect i ve phase II trial of CSAP . Patients were followed with serum PSA determinations , follow-up biopsies at 3 - 6 months postoperatively and a question naire to assess complications . A PSA of > 1 ng/ml or a positive biopsy was interpreted as progression . RESULTS Mean follow-up was 58.5 months . Patients needed a suprapubic catheter postoperatively for in mean 18 days . Transient penile numbness occurred in 15 % . Bothersome sloughing of dead tissue was noticed by 15 % of patients and 15 % needed a transurethral resection . Nine patients ( 17 % ) developed strictures and five patients stone formation in the prostatic urethra . One patient developed a perennial fistula . Thirty-nine out of 43 patients reporting on potency become impotent , nine patients developed a slight stress incontinence and one severe incontinence . At median follow-up , the actuarial progression-free survival was 38.9 % . Fourteen out of 50 patients biopsied ( 28 % ) had remaining cancer in their prostates . CONCLUSION High complication rates in combination with poor oncological outcome has made us stop using this treatment modality OBJECTIVES To determine in a prospect i ve pilot study the safety and efficacy of cryosurgical ablation for localized prostate carcinoma . METHODS A total of 87 cryosurgical procedures were performed on 76 consecutive patients between December 1994 and February 1998 . All patients had histologically proved adenocarcinoma of the prostate , with prostate-specific antigen ( PSA ) readings of less than 30 ng/mL. Clinical evaluations , PSA determinations , and patient self-reported quality -of-life question naires ( functional assessment of cancer treatment-prostate ; FACT-P ) were used to determine biochemical and clinical disease-free status and complications . Patients had a mean follow-up of 50 months ( minimum 36 ) . RESULTS Follow-up biopsies were performed in 73 patients , and 72 were negative for malignancy after one or more treatments . Ten patients required two treatments and 1 patient required three treatments . The 5-year overall and cancer-specific survival rate was 89 % ( 95 % confidence interval , 83 % to 97 % ) and 98.6 % ( 95 % confidence interval , 96 % to 100 % ) , respectively . The undetectable PSA rate ( less than 0.3 ng/mL ) for low-risk patients ( n = 13 ) was 60 % at 5 years ; for moderate-risk patients ( n = 23 ) , it was 77 % , and for high-risk patients ( n = 40 ) , 48 % . The corresponding percentage of patients with a PSA level less than 1.0 ng/mL at 5 years was 75 % , 89 % , and 76 % . Sloughing occurred in 3 patients ( 3.9 % ) , incontinence in 1 ( 1.3 % ) , and testicular abscess in 1 ( 1.3 % ) . At 3 years , 18 ( 47 % ) of 38 patients capable of unassisted intercourse at the time of cryosurgery had resumed sexual intercourse , 5 spontaneously and 13 with sildenafil or prostagl and in . CONCLUSIONS The results of this prospect i ve evaluation show cryosurgery to be both a safe and an effective option in the treatment of localized prostate cancer The current study was design ed to describe the long-term life quality
Output:
| Cryotherapy offers a potential alternative to st and ard therapies for the primary treatment of localised prostate cancer . |
MS213439 | ***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 a prospect i ve , r and omized clinical trial cognitive characteristics of schizophrenic patients were examined as predictors of the efficacy of a psychoeducational psychotherapeutic intervention . The aim of this study was to select adequate cognitive predictors . The reduction of the selected cognitive deficits by means of a psychoeducational psychotherapy was measured . Additionally , the prophylactic effects of the improvement of cognitive deficits were examined . Predictors of the course of illness were basic cognitive deficits and metacognitive constructs of 106 schizophrenic out patients . Additionally , the modification of the cognitive skills of these patients was taken into account . Relevant factors of the course of illness representing the therapeutic effect of the intervention were investigated within a five-year follow-up . By means of logistic regression analyses thought disorders ( AMDP system ) and idiosyncratic and fatalistic assumptions ( KK-scale ) were obtained as appropriate cognitive predictors of the long-term course of illness . Thought disorders and attentional deficits could not be improved significantly . Though , there was a correlation between the therapeutic improvement of idiosyncratic and fatalistic assumptions and the rehospitalization rate within the follow-up Within a controlled prospect i ve intervention study , schizophrenic out patients r and omly assigned to four treatment groups and one control group were assessed with regard to collaboration with drug treatment . In total , 39.3 % of 84 regular attenders of the psychoeducational training programme and 26.6 % of 64 control patients reported having persuaded their psychiatrists to modify their medication prescriptions . A total of 8.3 % and 7.8 % , respectively , modified their medication on their own initiative , although with subsequent approval by the psychiatrist , and 20.2 % and 15.6 % , respectively , modified their medication after consulting their psychiatrist . With regard to medication management , the groups did not differ either at post‐treatment or at follow‐up . At follow‐up , regular attenders showed a reduced fear of side‐effects , increased confidence in their medication and stable confidence in their physician . Among the control subjects , confidence in the medication and in their physician declined , and fear of side‐effects increased . Psychoeducational training therefore led to an optimization of patients ' attitudes toward treatment , but not to changes in medication management 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 Abstract The study examines long-term effects on rehospitalization rates of a psychoeducationally and cognitive-behaviorally oriented intervention for schizophrenic out patients and their key-persons . 191 patients and their key-persons were allocated by r and om into four different treatment groups and one control group . Five years after completion of treatment 126 patients were reexamined by interviews or case notes . The rate of patients experiencing psychiatric rehospitalization during the follow-up was assessed in each respective treatment group . Concerning rehospitalization rates there was no significant difference between controls ( n = 35 ) and patients of the four treatment groups ( n = 91 ) . There were , however , fewer rehospitalized patients in the group with combined psychoeducational and cognitive treatment , including key-person counselling ( 42 % ) , than in the control group ( 69 % ) . Regarding the overall functioning , the patients in this treatment group did slightly better than those in the control group . These results are in accordance with the findings of comparable studies OBJECTIVE The present study examined whether psychoeducational groups for patients with schizophrenic disorders and for their families can reduce rehospitalization rates and improve compliance . METHOD 236 in patients who met DSM-III-R criteria for schizophrenia or schizoaffective disorder and who had regular contact with at least 1 relative or other key person were r and omly assigned to 1 of 2 treatment conditions . In the intervention condition , patients and their relatives were encouraged to attend psychoeducational groups over a period of 4 to 5 months . The patients ' and relatives ' psychoeducational programs were separate , and each consisted of 8 sessions . Patients in the other treatment condition received routine care . Outcomes were compared over 12-month and 24-month follow-up periods . The study was conducted from 1990 to 1994 . RESULTS It was possible to significantly reduce the rehospitalization rate after 12 and 24 months in patients who attended psychoeducational groups compared with those receiving routine care ( p < .05 ) . Patients who attended psychoeducational groups showed better compliance than patients under routine care without psycho-education . CONCLUSIONS The results suggest that a relatively brief intervention of 8 psychoeducational sessions with systematic family involvement in simultaneous groups can considerably improve the treatment of schizophrenia . Psychoeducation should be routinely offered to all patients with schizophrenia and their families BACKGROUND A r and omised controlled trial was conducted in an acute treatment setting to examine the effectiveness of compliance therapy , a brief pragmatic intervention targeting treatment adherence in psychotic disorders , based on motivational interviewing and recent cognitive approaches to psychosis . METHOD Seventy-four patients with psychotic disorders according to DSM-III-R criteria recruited from consecutive admissions to an acute in-patient unit , received 4 - 6 sessions of either compliance therapy or non-specific counselling , and were followed-up over 18 months . The principal outcome measures were observer-rated compliance , attitudes to treatment , insight and social functioning . RESULTS Significant advantages were found for the compliance therapy group post-treatment on measures of insight , attitudes to treatment and observer-rated compliance which were retained over the follow-up period . Global social functioning improved relatively more over time in the compliance therapy group compared with the control group . Survival in the community prior to readmission was significantly longer in the compliance therapy group . CONCLUSIONS The results support the effectiveness of compliance therapy in improving functioning and community tenure after an acute psychotic episode OBJECTIVES To evaluate the effectiveness of a psychoeducation program for Chinese clients with schizophrenia and their family caregivers . METHODS A r and omized controlled trial was conducted . Seventy-three clients with a diagnosis of schizophrenia and their caregivers ( n=73 ) were recruited and r and omized into a study ( n=36 ) and control group ( n=37 ) . Ten psychoeducation sessions were provided to the study group . The outcomes were measured at the baseline , immediately after ( post-1 ) , six months ( post-2 ) , and 12 months after the intervention ( post-3 ) . RESULTS There were significant treatment effects across time for all client outcomes : adherence to medication ( p<0.01 ) , mental status ( p<0.01 ) , and insight into illness ( p<0.01 ) . However , no significant differences were found between groups at the post-3 measures for all client outcomes . For the caregivers , significant group differences were only detected in self-efficacy at the post-1 ( p=0.007 ) and post-2 ( p<0.001 ) measures , the level of satisfaction at the post-1 ( p=0.033 ) and post-2 ( p<0.021 ) measures , and the perception of family burden at the post-2 measures ( p=0.043 ) . CONCLUSION A psychoeducation intervention had positive effects on Chinese clients and their caregivers . However , these effects might not be sustained 12 months after the intervention . PRACTICE IMPLICATION S To substantiate its effects , psychoeducation should be an ongoing intervention , with its outcomes constantly evaluated BACKGROUND Family intervention in schizophrenia can reduce patient relapse and improve medication adherence , but few studies on this have involved a Chinese population . AIMS To examine the effects of a mutual support group for Chinese families of people with schizophrenia , compared with psychoeducation and st and ard care . METHOD R and omised controlled trial in Hong Kong with 96 families of out- patients with schizophrenia , of whom 32 received mutual support , 33 psychoeducation and 31 st and ard care . The psychoeducation group included patients in all the sessions , the mutual support group did not . Intervention was provided over 6 months , and patient- and family-related psychosocial outcomes were compared over an 18-month follow-up . RESULTS Mutual support consistently produced greater improvement in patient and family functioning and caregiver burden over the intervention and follow-up periods , compared with the other two conditions . The number of readmissions did not decrease significantly , but their duration did . CONCLUSIONS Mutual support for families of Chinese people with schizophrenia can substantially benefit family and patient functioning and caregiver burden Earlier studies of family psychoeducation and clinical reports on multiple family groups ( MFGs ) have reported substantial reductions in relapse rates for patients with schizophrenia . These groups offer an exp and ed social network and thereby may confer a margin of protection against relapse . However , to date , there has not been an empirical trial of this modality . The advent of family psychoeducational and behavioral management strategies provided the basis for an experimental , three-way comparison of psychoeducational MFGs to psychoeducation in a single-family format and to MFGs without psychoeducation , using symptomatic relapse as the outcome criterion . After 4 years , the psychoeducational MFGs were significantly more effective in extending remission than the single-family format , while the MFGs without psychoeducation approximated outcome in the psychoeducational MFGs . The respective relapse rates at 4 years were 50 % , 78 % , and 57 % ; MFGs averaged 12.5 % and 14 % per year . These results point toward an enhanced and independent , long-term therapeutic effect for multiple family groups , when combined with antipsychotic medication and psychoeducation , with especially promising cost-effectiveness Background The majority of patients with schizophrenia live with their relatives in Pakistan , thereby families experience a considerable burden . We aim ed to study the impact of psychoeducation on the burden of schizophrenia on the family in a r and omised controlled trial . Methods A total of 108 patients with schizophrenia and their family members from the outpatient department of a teaching hospital in Lahore , Pakistan were r and omised . Both groups received psychotropic drugs but one group received psychoeducation in addition . Family burden was assessed at the time of recruitment and at 6 months post intervention . Results In all , 99 patients and their relatives completed the treatment . There was significant reduction in burden at post-intervention assessment in the psychoeducation group based on intention to treat analysis . Conclusion Family psychoeducation can be an important intervention for patients with schizophrenia in Pakistan Family members of 55 patients with schizophrenia were r and omly assigned to a psychoeducational support group or to a control group . Support group participants showed greater knowledge of schizophrenia and greater satisfaction with health care services than did control group members . Psychological distress , coping behavior , and family satisfaction did not appear affected by support group participation ; nor were support groups associated with lower rehospitalization rates for patients Psychoeducational medication management training ( PMT ) , cognitive psychotherapy ( CP ) and key‐person counselling ( KC ) were carried out in various combinations in this r and omized , controlled intervention study of schizophrenic out‐ patients ( according to DSM‐III‐R ) . Special design characteristics of the study were a control group consisting of non‐specifically treated patients and a 2‐year follow‐up after completion of treatment in order to evaluate medium‐term effects . A total of 132 patients underwent a follow‐up examination 2 years after completion of treatment and were evaluated with an intention‐to‐treat approach . In the second follow‐up year , all treatment groups had lower but not significantly different relapse rates compared to the control group . The most intensive treatment ( PMT+CP+KC ) produces a clinical ly relevant reduction in rehospitalization rate ( a 26 % reduction compared to
Output:
| Based on mainly low to very low quality evidence from a limited number of studies , brief psychoeducation of any form appears to reduce relapse in the medium term , and promote medication compliance in the short term . |
MS213440 | ***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 The purpose of this prospect i ve r and omised trial was to assess whether an intramedullary nail is superior to a sliding hip screw in the treatment of multifragmentary intertrochanteric fractures Methods Eighty patients with a 31-A2.2 or A2.3 Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association ( AO/OTA ) intertrochanteric fracture were r and omly allocated to fixation with either the Gamma nail or the AMBI sliding hip screw device . Results All patients were followed up at one , three , six and 12 months postoperatively , except for nine who died . There was no statistical difference in Parker mobility score between groups . The Gamma nail group had significantly higher Barthel Index and EuroQol-5D ( EQ-5D ) scores than the AMBI group at 12 months . At the same time , the EQ-5D score had returned to its pre-operative values in the Gamma nail group but not in the AMBI group . There were no differences in mortality , radiation time and hospital stay . Duration of the operation , incision length and hip pain occurrence were significantly less in the Gamma nail group . Conclusions Few failures occur when unstable 31-A2.2 and A2.3 AO/OTA fractures are fixed with a sliding hip screw . Nevertheless , an intramedullary nail seems superior in reconstituting patients to their pre-operative state OBJECTIVE To compare the efficacy of the gamma nail ( GN ) to the dynamic hip screw ( DHS ) in the management of intertrochanteric hip fractures . DESIGN R and omized , prospect i ve clinical trial with a mean follow-up of 52 weeks ( range from 11 to 82 weeks ) . SETTING A university teaching hospital . PATIENTS One hundred and one patients with 102 fractures : 49 fractures were treated with the DHS and 53 fractures were treated with the GN . INTERVENTIONS Fracture fixation with the DHS or the GN . MAIN OUTCOME MEASURES Comparison of duration of operation , blood loss , early and late complications , functional outcome and duration of hospital stay . RESULTS There was no significant difference between the two groups with respect to intraoperative blood loss , days in hospital , time to union and eventual functional outcome . The length of the procedure and fluoroscopy time were longer for the GN group . CONCLUSIONS Both the GN and the DHS can be used effectively for the treatment of intertrochanteric fractures . In this study the DHS was associated with a lower risk of local complications and should still be considered to be the implant of choice for patients with intertrochanteric fractures The Gamma nail was introduced for the treatment of peritrochanteric fractures with the theoretical advantage of a load-sharing femoral component which could be implanted by a closed procedure . We report a r and omised prospect i ve study of 186 fractures treated by either the Gamma nail or a dynamic hip screw . Gamma nails were implanted with significantly shorter screening times , smaller incisions , and less intraoperative bleeding . The Gamma nail group had a shorter convalescence and earlier full weight-bearing , but there was no significant difference in mortality within six months , postoperative mobility , or hip function at review . More intra-operative complications were recorded in the Gamma nail group , mainly due to the mismatching of the femoral component of the nail to the small femurs of Chinese people . Use of a smaller modified nail reduced these complications . We conclude that with careful surgical technique and the modified femoral component , the Gamma nail is an advance in the treatment of peritrochanteric fractures Summary : Achieving bony union and early weight bearing in peritrochanteric femur fractures poses a continuous challenge for the orthopedic surgeon . Current st and ards of surgical fixation for the myriad possible fracture patterns include the compression hip screw ( CHS ) , the 90 ° /95 ° blade plate , and locked intramedullary nails . The gamma nail ( GN ) was design ed as a “ hybrid ” of these devices , combining theoretical biomechanical advantages that should allow earlier postoperative weight bearing with surgical technique advantages that should decrease operative morbidity . Because these theoretical advantages were unproven in a clinical setting , we prospect ively r and omized 75 consecutive patients with peritrochanteric femur fractures into two groups to examine the fixation of these fractures with the GN as compared to the CHS . We found no significant differences in preoperative or intraoperative parameters . Postoperatively , the subtrochanteric fracture group treated with the GN achieved earlier weightbearing status , although this was not statistically significant . 72 patients were available for follow-up at a minimum of 6 months . All fractures had clinical ly and radiographically healed , and 94 % of the patients continued to be ambulatory . Major complications included missed distal locking screws ( one patient ) , cutting out of the lag screw superiorly in the femoral head ( two patients ) , and a femur fracture at the distal end of the GN ( one patient ) . In our series , the GN produced clinical results commensurate with current st and ards of fixation for peritrochanteric femur fractures . Although the GN allowed earlier independent weightbearing status in patients with subtrochanteric fractures , the procedure was technically more dem and ing and had a significant learning curve OBJECTIVES To present several alternative approaches to describing the range and functional outcomes of patients with hip fracture . DESIGN Prospect i ve study with concurrent medical records data collection and patient and proxy interviews at the time of hospitalization and 6 months later . SETTING Four hospitals in the New York metropolitan area . PARTICIPANTS Five hundred seventy-one hospitalized adults aged 50 and older with hip fracture between July 1997 and August 1998 . MEASUREMENTS Rates of return to function in four physical domains , mortality , and nursing home residence at 6 months . Cluster analysis was used to describe the heterogeneity among the sample and identify variations in 6-month mortality , nursing home residence , and level of functioning and to develop a patient classification tree with associated patient outcomes at 6 months postfracture . RESULTS In locomotion , transfers , and self-care , 33 % to 37 % of patients returned to their prior level of function by 6 months , including those needing assistance , but only 24 % were independent in locomotion at 6 months . Cluster analysis identified eight patient subgroups that had distinct baseline features and variable outcomes at 6 months . The patient classification tree used four variables : atypical functional status ( independent in locomotion but dependent in other domains ) ; nursing home residence ; independence/dependence in self-care ; and age younger than 85 or 85 and older that identified five subgroups with variable 6-month outcomes that clinicians may use to predict likely outcomes for their patients . CONCLUSION Patients with hip fracture are heterogeneous with respect to baseline and outcome characteristics . Clinicians may be better able to give patients and caregivers information on expected outcomes based on presenting characteristics used in the classification tree This prospect i ve r and omized study compared the outcome of elderly patients with an unstable pertrochanteric fracture , treated with a proximal femoral nail antirotation device ( PFNA ; n = 51 ) or a dynamic hip screw ( DHS ; n = 55 ) . All patients in the DHS group and nine in the PFNA group had open reductions . Incisions were significantly shorter for the PFNA than the DHS group . Blood loss and the number of patients requiring postoperative blood transfusions were significantly greater , but operation and fluoroscopy times were significantly shorter , for the DHS versus the PFNA group . Time to mobilization with a frame was significantly shorter in the PFNA group , and post-operative complications were more common in the DHS group . Poor fracture reduction led to three revisions . All fractures in both groups united during follow-up . The PFNA allowed earlier mobilization and faster recovery than the DHS . The PFNA is a highly acceptable , minimally invasive implant for unstable fractures Objectives : To compare the results between a new intramedullary Gamma nail and a compression hip screw in the treatment of trochanteric fractures . Design : Prospect i ve r and omized . Setting : Level 1 trauma center . Patients : Two hundred ten consecutive patients older than 65 years with trochanteric femoral fractures . Interventions : Treatment with a compression hip screw or a new design of the Trochanteric Gamma nail ( 180 mm in length with a mediolateral angle of 4 ° and available only with a proximal diameter of 17 mm and distal diameter of 11 mm ) . Main Outcome Measurements : Operative and fluoroscopy times , blood loss , functional outcome , complication rate , and failure of fixation . Results : The Trochanteric Gamma nail was used in 104 patients and the compression hip screw in 106 . The 2 groups were similar in terms of their preoperative data , with a median follow-up of 13.6 months ( range 12 - 30 ) . The results show no difference in operating time ( P = 0.21 ) , but the Trochanteric Gamma nail group had a significantly shorter fluoroscopy time ( P = 0.006 ) , and the number of patients transfused and the mean of units of blood transfused were significantly less in the Trochanteric Gamma nail group ( P = 0.013 , 0.046 , respectively ) . Mortality within 12 months was similar in both groups ( P = 0.83 ) . All fractures were radiographically healed at the last visit . There was no difference in intraoperative and postoperative complications or rate of fixation failure between the 2 groups , and no case of secondary shaft fracture of the femur was encountered in this study . In the entire series , there was no difference in the functional outcome ( P = 0.74 ) , but the postoperative walking ability was better in those patients with unstable fractures who were treated with the Trochanteric Gamma nail ( P = 0.017 ) . Conclusions : The new Trochanteric Gamma nail is an effective method for the treatment of trochanteric femoral fractures in elderly patients . The indication for either Trochanteric Gamma nail or compression hip screw is similar in stable fractures , but we recommend the use of the Trochanteric Gamma nail for unstable trochanteric fractures A prospect i ve , r and omised , controlled trial was performed to compare the outcome of treatment of unstable trochanteric fractures with either a short proximal femoral nail antirotation ( PFNA ) or dynamic hip screw ( DHS ) . Eighty one patients with unstable fracture of the proximal part of the femur were r and omised , at the time of admission , for fixation with either a short PFNA ( n=42 ) or DHS ( n= 39 ) . The primary outcome measure was reoperation within the first postoperative year and mortality at the end of one year . Operative time , fluoroscopy time , blood loss , and any intra-operative complication were recorded for each patient . Clinical and radiological follow-up was undertaken for a minimum of 36 months . Any changes in the position of the implant or fixation failure were recorded . Hip range of motion , pain in the hip or thigh and return to work were used to compare the outcomes . There was no significant difference between 1 year mortality rates for the two groups . The mean operative time was significantly less in PFNA group ( 25 min ) than in the DHS group ( 38 min ) . Patients treated with a PFNA experienced a shorter fluoroscopy time and less blood loss . Six patients in DHS group had implant failure while none experienced this in PFNA group . The PFNA group had a better functional outcome than the DHS group We report a prospect i ve , r and omized , controlled trial , comparing the results of treatment with a dynamic hip screw ( DHS ) and a gamma nail in 95 consecutive patients with peri-trochanteric fractures of the femur . The DHS was used in 48 patients , the gamma nail in 47 . Clinical and radiological outcomes were similar , but the gamma nail was associated with a higher incidence of complications , in particular fracture of the femur below the implant in eight cases . This is consistent with previous reports , and we do not recommend the gamma nail for the treatment of peri-trochanteric femoral fractures A prospect i ve , r and omized study comparing the compression hip screw with the Gamma nail in the treatment of 426 intertrochanteric fractures is reported . The median patient age was 80 years , and 71 % were women The compression hip screw operation took less time except in Evans Type 5 fractures . Blood loss generally was less in the compression hip screw group except in patients with Type 5 fractures . The most frequent surgical problem for patients in the Gamma group was problems with distal locking . Cephalic position of the femoral head screw and cut-out were seen more often in the Gamma nail group . The Gamma nail more frequently preserved the fracture position obtained perioperatively . Whether there was distal locking of the Gamma nail in unstable fractures did not seem to affect the healing rate . Additional fissures or fractures in the proximal femur occurred during five Gamma nail operations and two compression hip screw operations . Postoperative walking ability did not differ between the groups . At 6 months 88 % of the fractures were healed . In less comminuted fractures , the compression hip screw method is the preferred method of treatment whereas the Gamma nail is an alternative treatment for more comminuted Evans Type 5 fractures This prospect i ve , r and omized study compared the functional outcome and complications associated with a proximal femoral nail antirotation ( PFNA ) device with those of a traditional extramedullary device , the dynamic hip screw ( DHS ) , in patients with trochanteric fracture . A total of 121 patients were r and omized to the PFNA group ( n = 5
Output:
| Across all population s , greater reductions in blood loss and operation time were observed for PFNA than for other treatments .
Conclusions The findings provide supporting evidence demonstrating the superiority of PFNA over other treatments for intertrochanteric femoral fracture .
PFNA treatment results in the lowest amount of blood loss and the shortest operation time .
These findings add to the existing knowledge of intertrochanteric femoral fracture treatment options |
MS213441 | ***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 Shalfawi , SAI , Haugen , T , Jakobsen , TA , Enoksen , E , and Tønnessen , E. The effect of combined resisted agility and repeated sprint training vs. strength training on female elite soccer players . J Strength Cond Res 27(11 ) : 2966–2972 , 2013—The aim of this study was to compare the effects of in-season combined resisted agility and repeated sprint training with strength training on soccer players ' agility , linear single sprint speed , vertical jump , repeated sprint ability ( RSA ) , and aerobic capacity . Twenty well-trained elite female soccer players of age ± SD 19.4 ± 4.4 years volunteered to participate in this study . The participants were r and omly assigned to either the agility and repeated sprint training group or to the strength training group . All the participants were tested before and after a 10-week specific conditioning program . The pretest and posttest were conducted on 3 separate days with 1 day of low-intensity training in between . Test day 1 consisted of squat jump ( SJ ) , countermovement jump ( CMJ ) , and RSA . Test day 2 consisted of a 40-m maximal linear sprint and an agility test , whereas a Beep test was conducted on test day 3 to assess aerobic capacity . The agility and repeated sprint training implemented in this study did not have a significant effect on agility , although there was a tendency for moderate improvements from 8.23 ± 0.32 to 8.06 ± 0.21 seconds ( d = 0.8 ) . There was a significant ( p < 0.01 ) and moderate-positive effect on Beep-test performance from level 9.6 ± 1.4 to level 10.8 ± 1.0 , and only a trivial small effect on all other physical variables measured in this study . The strength training group had a positive , moderate , and significant ( p < 0.01 ) effect on Beep-test performance from level 9.7 ± 1.3 to level 10.9 ± 1.2 ( d = 1.0 ) and a significant ( p < 0.05 ) but small effect ( d = 0.5 ) on SJ performance ( 25.9 ± 2.7 to 27.5 ± 4.1 cm ) . Furthermore , the strength training implemented in this study had a trivial and negative effect on agility performance ( d = −0.1 ) . No between-group differences were observed . The outcome of this study indicates the importance of a well-planned program of conditioning that does not result in a decreased performance of the players , the great importance of strength and conditioning specialist in implementing the training program , and the importance of choosing the time of the year to implement such conditioning training programs . However , the fact that the present training program did not cause any decline in performance indicates that it is useful in maintaining the soccer players ' physical performance during the competition period ABSTRACT This study aim ed to investigate the effect of air pollution on diurnal variation of performance in anaerobic tests , cardiovascular and hematological parameters , and blood gases on soccer players following the Yo – Yo Intermittent Recovery Test Level-1 ( YYIRT1 ) . In a r and omized order , 11 healthy soccer players ( mean age : 21.8 [ range : 20–24 ] years ; height : 178.00 [ range : 1.64–1.83 ] cm ; body mass index [ BMI ] : 23.57 [ range : 20.45–28.03 ] kg.m−2 ) performed a YYIRT1 at two different times of day ( TOD ) ( 08:00 h and 18:00 h ) in two areas ( i.e. polluted ( PA ) and non-polluted ( NPA ) ) with a recovery period of ≥ 72 h in between , to determine the maximal oxygen uptake ( VO2max ) . In each test session : resting oral temperature is measured , anaerobic performances ( pre- and post-YYIRT1 ) were performed , cardiovascular parameters and blood sample s were collected at : rest , 3 min and 60 min after the YYIRT1 , to assess blood gases and hematological parameters . Our results showed that , agility performance , VO2max , red blood cells ( RBC ) , hemoglobin ( Hb ) , pH , and bicarbonate levels ( HCO3− ) decrease significantly ( p < 0.001 ) following the YYIRT1 in PA compared to NPA . Likewise , the heart rate ( HR ) , systolic blood pressure ( SBP ) , platelets ( PLT ) , white blood cells ( WBC ) , neutrophiles ( NEUT ) , lymphocytes ( LYM ) , and partial pressure of CO2 levels ( PvCO2 ) were significantly higher ( p < 0.001 ) in PA . This effect was slightly accentuated at 18:00 h for some parameters ( i.e. Agility , HCO3− , HR , PvCO2 , RBC , SBP ) . However , performances of sprint and Sargent jump test ( SJT ) , oral temperature , rate of perceived exertion scales ( RPE ) , partial pressure of O2 ( PvO2 ) , diastolic blood pressure ( DBP ) , and monocytes ( MON ) were not affected by pollution ( p > 0.05 ) . In conclusion , pollution seems to be critical for health stability and performance in response to YYIRT1 especially in the evening and the winter season . Therefore , coaches and athletes should draw attention to the potential importance of l and use planning in their training sessions and competitions in the morning in polluted area to minimize the risk of pollution exposure The purpose of this study was to compare the effects of combined strength and plyometric training with strength training alone on power-related measurements in professional soccer players . Subjects in the intervention team were r and omly divided into 2 groups . Group ST ( n = 6 ) performed heavy strength training twice a week for 7 weeks in addition to 6 to 8 soccer sessions a week . Group ST+P ( n = 8) performed a plyometric training program in addition to the same training as the ST group . The control group ( n = 7 ) performed 6 to 8 soccer sessions a week . Pretests and posttests were 1 repetition maximum ( 1RM ) half squat , countermovement jump ( CMJ ) , squat jump ( SJ ) , 4-bounce test ( 4BT ) , peak power in half squat with 20 kg , 35 kg , and 50 kg ( PP20 , PP35 , and PP50 , respectively ) , sprint acceleration , peak sprint velocity , and total time on 40-m sprint . There were no significant differences between the ST+P group and ST group . Thus , the groups were pooled into 1 intervention group . The intervention group significantly improved in all measurements except CMJ , while the control group showed significant improvements only in PP20 . There was a significant difference in relative improvement between the intervention group and control group in 1RM half squat , 4BT , and SJ . However , a significant difference between groups was not observed in PP20 , PP35 , sprint acceleration , peak sprinting velocity , and total time on 40-m sprint . The results suggest that there are no significant performance-enhancing effects of combining strength and plyometric training in professional soccer players concurrently performing 6 to 8 soccer sessions a week compared to strength training alone . However , heavy strength training leads to significant gains in strength and power-related measurements in professional soccer players OBJECTIVES This study investigated the acute effects of a currently implemented team-sport warm-up and two alternative , high-intensity , short- duration protocol s - 5 repetition maximum leg press and small-sided games . DESIGN Ten male soccer players participated in a r and omised , cross-over study . METHODS Participants performed a team-sport , a leg-press , or a small-sided game warm-up . Subsequent performance tests included counter-movement jump , reactive agility , and 15 × 20 m sprints embedded in an intermittent exercise task . Physiological measures included core temperature , blood lactate concentration , heart rate and rating of perceived exertion . Data were analysed using the effect size statistic with 90 % confidence intervals , and percentage change , to determine magnitude of effects . RESULTS Counter-movement jump height improved following the small-sided game ( 6 % , ES : 0.8±0.8 ) and leg-press warm-up ( 2 % , ES : 0.3±0.5 ) , but not after the team-sport warm-up ( ' unclear ' effect ) . Reactive agility improved after the small-sided game ( 4 % , ES : 0.8±0.7 ) and leg-press warm-ups only ( 5 % , ES : 1.1±0.7 ) , when compared to baseline . Mean 20-m sprint times during the intermittent exercise task improved following the leg-press warm-up , when compared with the small-sided game ( 9 % , ES : 0.9±0.3 ) and team-sport warm-ups ( 7 % , ES : 0.6±0.6 ) . Core temperature was lower following the leg-press warm-up compared to small-sided game ( 1 % , ES : 0.9±0.7 ) and the team-sport WUs ( 2 % , ES : 2.4±0.8 ) . Blood lactate was highest following the small-sided game ( 67 % , ES : 2.7±0.8 ) and team-sport warm-ups ( 66 % , ES : 2.9±0.9 ) . CONCLUSIONS A leg-press and small-sided game warm-up may improve acute team-sport performance tests when compared to a traditional warm-up protocol Sayers , AL , Farley , RS , Fuller , DK , Jubenville , CB , and Caputo , JL . The effect of static stretching on phases of sprint performance in elite soccer players . J Strength Cond Res 22(5 ) : 1416 - 1421 , 2008-The purpose of this study was to determine which phase of a 30-m sprint ( acceleration and /or maximal velocity ) was affected by preperformance static stretching . Data were collected from 20 elite female soccer players . On two nonconsecutive days , participants were r and omly assigned to either the stretch or no-stretch condition . On the first day , the athletes in the no-stretch condition completed a st and ard warm-up protocol and then performed three 30-m sprints , with a 2-minute rest between each sprint . The athletes in the stretch condition performed the st and ard warm-up protocol , completed a stretching routine of the hamstrings , quadriceps , and calf muscles , and then immediately performed three 30-m sprints , also with a 2-minute rest between each sprint . On the second day , the groups were reversed , and identical procedures were followed . One-way repeated- measures analyses of variance revealed a statistically significant difference in acceleration ( p < 0.0167 ) , maximal-velocity sprint time ( p < 0.0167 ) , and overall sprint time ( p < 0.0167 ) between the stretch and no-stretch conditions . Static stretching before sprinting result ed in slower times in all three performance variables . These findings provide evidence that static stretching exerts a negative effect on sprint performance and should not be included as part of the preparation routine for physical activity that requires sprinting Thomas , K , French , D , and Hayes , PR . The effect of two plyometric training techniques on muscular power and agility in youth soccer players . J Strength Cond Res 23(1 ) : 332 - 335 , 2009-The aim of this study was to compare the effects of two plyometric training techniques on power and agility in youth soccer players . Twelve males from a semiprofessional football club 's academy ( age = 17.3 ± 0.4 years , stature = 177.9 ± 5.1 cm , mass = 68.7 ± 5.6 kg ) were r and omly assigned to 6 weeks of depth jump ( DJ ) or countermovement jump ( CMJ ) training twice weekly . Participants in the DJ group performed drop jumps with instructions to minimize ground-contact time while maximizing height . Participants in the CMJ group performed jumps from a st and ing start position with instructions to gain maximum jump height . Posttraining , both groups experienced improvements in vertical jump height ( p < 0.05 ) and agility time ( p < 0.05 ) and no change in sprint performance ( p > 0.05 ) . There were no differences between the treatment groups ( p > 0.05 ) . The study concludes that both DJ and CMJ plyometrics are worthwhile training activities for improving power and agility in youth soccer players Spierer , DK , Petersen , RA , and Duffy , K. Response time to stimuli in Division I soccer players . J Strength Cond Res 25(4 ) : 1134 - 1141 , 2011-The purpose of this investigation was to examine the effect of auditory stimuli ( AS ) and visual stimuli ( VS ) on sprint time , sprint speed , and reaction time in National Collegiate Athletic Association Division I male soccer players . Fifteen healthy subjects ( mean age 22.1 ± 1.6 years ) volunteered for the study . This experiment was conducted on a regulation soccer field , using a wireless timing system . Subjects stood on a touch- and -release pad and were instructed a prompt ( AS : “ go ” comm and via a microphone interface , VS : movement of a player located 10 m from the start ) to run 20 m through the finish line timing gates without decelerating . After 3 submaximal sprint trials at 50 % , conditions ( AS and VS ) were r and omized and performed 3 times by each subject . The best sprint time , sprint speed , and reaction time were recorded . Paired t-tests were conducted on dependent variables to determine statistically significant differences . An alpha level was set at p ≤ 0.05 . Sprint
Output:
| Except for agility tests , several tests for all categories with acceptable levels of validity and high levels of reliability for adult soccer players are available . |
MS213442 | ***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: DFP [ 3-(2-propyloxy)-(4-methyl-sulfonylphenyl)-(5,5-dimethyl)-fu ranone ] is a highly specific cyclooxygenase-2 inhibitor ( > 2500-fold selective in transfected Chinese hamster ovary cell assays ) that has demonstrated efficacy in pre clinical models of pain and inflammation . The present single-dose , r and omized , double-masked , double-dummy , placebo-controlled , parallel-group study was undertaken to compare DFP 5 , 25 , and 50 mg with naproxen sodium 550 mg and with placebo in 196 patients ( mean age , 25.8 years ; 187 [ 95.4 % ] males ) who experienced moderate-to-severe pain after surgical removal of > or = 2 third molars . Overall analgesic effect , duration of effect , time to onset of analgesic effect , peak analgesic effect , and tolerability were assessed over a 24-hour postdose period . Both DFP 25 and 50 mg , as well as the active comparator , naproxen sodium 550 mg , were significantly more effective than placebo . The onset of analgesic effect in the DFP 25-mg , DFP 50-mg , and naproxen sodium 550-mg groups did not differ significantly . DFP was generally well tolerated in single doses up to 50 mg . DFP 50 mg was efficacious in the treatment of postoperative dental pain and was indistinguishable from the active comparator , naproxen sodium 550 mg In a double-blind , parallel , placebo-controlled study , 203 patients with post-operative dental pain following the extraction of one or two bony impacted third molars were r and omized to receive a single dose of naproxen sodium 220 mg , ibuprofen 200 mg or placebo . Pain intensity and pain relief were assessed at intervals for 12 hours postdose . Both active drugs demonstrated superior analgesic efficacy over placebo . Naproxen sodium and ibuprofen were comparable both in onset of analgesic action and in pain relief . From 1 to 12 hours postdose , naproxen sodium showed a trend for superior analgesic efficacy compared with ibuprofen ; this trend reached statistical significance at the 12-hour time point . Both drugs were well-tolerated and effective analgesics for postoperative dental pain Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size Background Naproxen and naproxen sodium are non-steroidal anti-inflammatory drugs used in a variety of painful conditions , including the treatment of postoperative pain . This review aims to assess the efficacy , safety and duration of action of a single oral dose of naproxen/naproxen sodium for moderate to severe acute postoperative pain in adults , compared with placebo . Methods The Cochrane Library ( issue 4 2002 ) , EMBASE , PubMed , MEDLINE and an in-house data base were search ed for r and omised , double blind , placebo controlled trials of a single dose of orally administered naproxen or naproxen sodium in adults with acute postoperative pain . Pain relief or pain intensity data were extracted and converted into dichotomous information to give the number of patients with at least 50 % pain relief over 4 to 6 hours . Relative benefit and number-needed-to-treat were then calculated . The percentage of patients with any adverse event , number-needed-to-harm , and time to remedication were also calculated . Results Ten trials with 996 patients in met the inclusion criteria . Six trials compared naproxen sodium 550 mg ( 252 patients ) with placebo ( 248 patients ) ; the NNT for at least 50 % pain relief over six hours was 2.6 ( 95 % confidence interval 2.2 to 3.2 ) . There was no significant difference between the number of patients experiencing any adverse event on treatment compared with placebo . Weighted mean time to remedication was 7.6 hours for naproxen sodium 550 mg ( 206 patients ) and 2.6 hours for placebo ( 205 patients ) . Four other trials used lower doses . Conclusion A single oral dose of naproxen sodium 550 mg is an effective analgesic in the treatment of acute postoperative pain . A low incidence of adverse events was found , although these were not reported consistently Abstract A multidisciplinary , double blind , parallel placebo controlled investigation was made to find an effective anti-inflammatory drug which prevents postoperative swelling , trismus and a general feeling of malaise . An additional aim was to evaluate objective ly the anti-inflammatory properties of anti-rheumatics . In 126 healthy patients , who were without complaints , the lower third molar was surgically removed . A drug had to be taken orally according to a fixed scheme for 4 days . Glafenine had to be taken in case of pain . The number of tablets taken was used to quantify pain . Swelling of the cheek was measured photographically and trismus was deducible from the maximal mouth-opening . The drugs investigated were betamethasone 14.5 mg decreasing over 4 days , ibuprofen 1200 mg/day , indomethacin 150 mg/day , naproxen 750 mg/day , niflumic acid 1000 mg/day , oxyphenylbutazone 600 mg/day and tranexamic acid 2000 mg/day . Oxyphenylbutazone and tranexamic acid were not significantly different from placebo in their pain-killing effects . Betamethasone prevents swelling and trismus significantly more than the placebo . Betamethasone is significantly better than the other drugs in the prevention of swelling . Reduction of the swelling by anti-rheumatics may be 10–15 % and a 20 % reduction of trismus is to be expected . The strongest analgesic is niflumic acid . Tranexamic acid may perhaps reduce the swelling by 28 % . The question naire and the blood- and urine-test showed that anti-rheumatics have to be considered to be acetylsalicylic acid-like drugs . Serious side effects have been reported previously for anti-rheumatics . When taken for a short time , corticosteroids are very safe drugs with a few mild side-effects . Many patients experience a slight euphoria . Betamethasone , in a dosage of 14.5 mg decreasingly divided over 4 days prevents pain by 80 % , swelling by 65 % and trismus by 40 % compared with the placebo group . This safe drug is recommended in elective surgery Oral naproxen in doses of 100 , 200 and 400 mg was compared with oral meperidine in doses of 25 and 75 mg , in a double-blind , single-dose , completely-r and omized study of patients with postoperative pain . One hundred patients were studied , twenty for each of the five treatments . The patients 1 subjective pain scores were recorded by an observer for four hours after administration of the treatment . Dose-effect trends were present with both naproxen and meperidine . Naproxen 400 mg performed the best of all treatments in the study ; on pain-score measurements it was significantly superior to meperidine 25 mg ; and in terms of the number of patients requiring re-medication for pain during the four-hour observation period , significantly fewer patients failed on naproxen 400 than on naproxen 100 mg . No appreciable excess of side effects occurred with naproxen A double-blind parallel r and omized study comparing naproxen 600 mg , naproxen 400 mg , and propoxyphene 65 mg was performed in 105 patients suffering from pain after orthopedic surgery . A significant difference in analgesic effectiveness was shown between the three drugs with successful analgesia recorded in 66 % of patients who received naproxen 600 mg , 37 % of those who received naproxen 400 mg , and 20 % of those who received propoxyphene 65 mg ( X2 2dt= 15.34 , p<0.005 ) . Naproxen 600 mg provided successful analgesia more often than did naproxen 400 mg . Complaints were mild but frequent with ail drugs ( 36 % of patients ) . No serious side effects were & NA ; There is uncertainty over whether the patient group in which acute pain studies are conducted ( pain model ) has any influence on the estimate of analgesic efficacy . Data from four recently up date d systematic review s of aspirin 600/650 mg , paracetamol 600/650 mg , paracetamol 1000 mg and ibuprofen 400 mg were used to investigate the influence of pain model . Area under the pain relief versus time curve equivalent to at least 50 % maximum pain relief over 6 h was used as the outcome measure . Event rates with treatment and placebo , and relative benefit ( RB ) and number needed to treat ( NNT ) were used as outputs from the meta‐analyses . The event rate with placebo was systematic ally statistically lower for dental than postsurgical pain for all four treatments . Event rates with analgesics , RB and NNT were infrequently different between the pain models . Systematic difference in the estimate of analgesic efficacy between dental and postsurgical pain models remains unproven , and , on balance , no major difference is likely One hundred and eighty patients scheduled for day-care surgery were allocated r and omly to one of three groups to receive naproxen sodium 1100 mg 1 h prior to surgery , naproxen sodium 1100 mg immediately after surgery , or placebo . The pre-surgery naproxen sodium group had significantly lower pain scores 1 h post-operatively and at discharge than the placebo group . At discharge both treatment groups were better than placebo . At 24 h post-operatively only the post-operative naproxen sodium group had lower pain scores . There was no difference in post-operative analgesic requirements until discharge between the groups , but at 24 h post-operatively the placebo group had required significantly more analgesics than the treatment groups . A question naire concerning general acceptability of anaesthesia/analgesia showed similar results . Our conclusion is that naproxen is better than placebo for treatment of post-operative pain . The time of administration pre- or post-operatively is important for the immediate post-operative pain , but we found no support for the existence of ' pre-emptive analgesia ' In a double-blind study , 198 out patients with pain after oral surgery were r and omly assigned to treatment with a single oral dose of naproxen sodium 550 mg , codeine sulfate 60 mg , a combination of naproxen sodium 550 mg with codeine sulfate 60 mg , aspirin 650 mg or placebo . Using a self-rating record , subjects rated their pain and its relief hourly for 12 hours after medication . Orthogonal contrasts for the four treatments making up the factorial component showed that the naproxen effect was significant for every measurement of total and peak analgesia ; the codeine effect was significant for total and peak pain relief and patients ' overall evaluation . The naproxen-codeine interaction was not statistically significant for any measure , which suggests that the analgesic effect of the combination represents the additive effect of its constituents . Based on pairwise comparisons , aspirin was significantly superior to placebo for most measures of effect , naproxen was significantly superior to both aspirin and codeine for all measures and the combination was significantly superior to naproxen for patients '
Output:
| Use of rescue medication was significantly less common with naproxen than placebo .
Associated adverse events were generally of mild to moderate severity and rarely led to withdrawal .
Doses equivalent to 500 mg and 400 mg naproxen administered orally provided effective analgesia to adults with moderate to severe acute postoperative pain . |
MS213443 | ***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 conduct the first rigorous evaluation of the long-term effect of the Comprehensive Rural Health Project on childhood mortality in rural Maharashtra . METHODS Background information and full birth histories were collected by conducting household surveys and interviewing women . Control villages resembling project villages in terms of population size were r and omly selected from an area enclosed by two ellipses centred around , but not including , the project area . An equal number of villages and approximately equal numbers of households and women were r and omly sample d from both areas . Cox models with robust st and ard errors were used to compare the hazard of death among children under 5 years of age in project and control villages . FINDINGS The hazard of death was reduced by 30 % ( 95 % confidence interval , CI : 6 % to 48 % ) after the neonatal period in the project villages compared with control villages after adjustment for caste and religion of subjects and for availability of irrigation in the villages . During the neonatal period there was an increase of 3 % in the hazard of death , but it was not statistically significant ( 95 % CI : -18 % to 29 % ) . CONCLUSION Our methods provide useful tools for evaluating long-running community-based primary health care programmes . Our findings add to the growing debate on the long-term sustainability of community-based interventions design ed to reduce child mortality The adage “ do n’t throw the baby out with the bathwater ” advises us not to discard the essential along with the unessential , whether due to impatience or frustration . 1 This issue of the journal includes reports on prospect i ve evaluations of the integrated community case management ( iCCM ) of childhood illness strategy in Burkina Faso , 2 Ethiopia , 3 and Malawi . 4 iCCM seeks to reduce child mortality by making effective treatment of pneumonia , diarrhea , and malaria available from trained health workers at community level . 5 In this commentary , we show results from the three countries , highlighting hard-won lessons about iCCM ’s potential to prevent unnecessary deaths among children . The independent iCCM evaluations were design ed in 2009– 2010 , as a part of the Catalytic Initiative to Save a Million Lives 6 spearheaded by Canada and involving the Bill & Melinda Gates Foundation , the U.K. Department for International Development , the United Nations Children ’s Fund , the World Health Organization , the Doris Duke Charitable Foundation , and others . The goal of the Catalytic Initiative was to support and measure the impact of strong , coordinated efforts to deliver high-impact interventions to reduce under-five mortality in low-income , high-burden countries , with a particular focus on providing treatment for childhood pneumonia , diarrhea , and malaria at community level using iCCM . The evaluation in each setting was conducted in collaboration with local research institutions , based on a locally adapted version of the common evaluation framework for maternal , newborn , and child health ( MNCH ) . 7 The evaluation design s were built on impact models reflecting the pathway to child survival . Beginning with policy and program inputs , the pathway moves to project implementation and intermediate outputs such as improved provision of quality services , strengthened health systems , and increased utilization . Continuing to coverage and behavioral outcomes , the pathway culminates in impact of under-five and postneonatal mortality . We focus on mortality among children aged 2–59 months here , because the iCCM strategy did not include guidelines for children under 2 months of age . Detailed methods are described in the individual papers ; Table 1 provides a summary . All sites documented program inputs and context ual factors that may have affected program implementation or effectiveness . The evaluation teams shared intermediate and final results with governments and partners as a basis for strengthening iCCM implementation . Selected results across the three countries are shown in Table 2 . We reanalyzed some variables to maximize comparability across countries ; in some instances , results presented here are not included in the series papers . iCCM was not associated with accelerated mortality declines in children aged 2–59 months during the 2- to 4-year evaluation periods in these three setting s. The reasons for this lack of association likely varied across setting s , as does the likelihood that these programs may achieve measureable impact after additional years of sustained implementation . In Burkina Faso , iCCM implementation did not reflect current best practice for design ing and implementing effective MNCH programs . The program relied on community health worker ( CHW ) lay volunteers . The initial training was organized as a “ cascade ” in which representatives from districts were trained and then requested to organize subdistrict-level training sessions to train over 3,000 CHWs in the space of a few months , with minimal support or supervision . The training included written material s even though many of the Objective To determine the effect of implementation of the Integrated Management of Neonatal and Childhood Illness strategy on treatment seeking practice s and on neonatal and infant morbidity . Design Cluster r and omised trial . Setting Haryana , India . Participants 29 667 births in nine intervention clusters and 30 813 births in nine control clusters . Main outcome measures The pre-specified outcome was the effect on treatment seeking practice s. Post hoc exploratory analyses assessed morbidity , hospital admission , post-neonatal infant care , and nutritional status outcomes . Interventions The Integrated Management of Neonatal and Childhood Illness intervention included home visits by community health workers , improved case management of sick children , and strengthening of health systems . Outcomes were ascertained through interviews with r and omly selected caregivers : 6204 , 3073 , and 2045 in intervention clusters and 6163 , 3048 , and 2017 in control clusters at ages 29 days , 6 months , and 12 months , respectively . Results In the intervention cluster , treatment was sought more often from an appropriate provider for severe neonatal illness ( risk ratio 1.76 , 95 % confidence interval 1.38 to 2.24 ) , for local neonatal infection ( 4.86 , 3.80 to 6.21 ) , and for diarrhoea at 6 months ( 1.96 , 1.38 to 2.79 ) and 12 months ( 1.22 , 1.06 to 1.42 ) and pneumonia at 6 months ( 2.09 , 1.31 to 3.33 ) and 12 months ( 1.44 , 1.00 to 2.08 ) . Intervention mothers reported fewer episodes of severe neonatal illness ( risk ratio 0.82 , 0.67 to 0.99 ) and lower prevalence of diarrhoea ( 0.71 , 0.60 to 0.83 ) and pneumonia ( 0.73 , 0.52 to 1.04 ) in the two weeks preceding the 6 month interview and of diarrhoea ( 0.63 , 0.49 to 0.80 ) and pneumonia ( 0.60 , 0.46 to 0.78 ) in the two weeks preceding the 12 month interview . Infants in the intervention clusters were more likely to still be exclusively breast fed in the sixth month of life ( risk ratio 3.19 , 2.67 to 3.81 ) . Conclusion Implementation of the Integrated Management of Neonatal and Childhood Illness programme was associated with timely treatment seeking from appropriate providers and reduced morbidity , a likely explanation for the reduction in mortality observed following implementation of the programme in this study . Trial registration Clinical trials NCT00474981 ; ICMR Clinical Trial Registry CTRI/2009/091/000715 OBJECTIVE To conduct an impact assessment of an intervention to enhance the provision of community-based integrated services for tuberculosis ( TB ) , human immunodeficiency virus ( HIV ) and prevention of mother-to-child transmission ( PMTCT ) . METHODS The intervention consisted of a combination of training of community care workers ( CCWs ) , structural adjustments , harmonisation of scope of practice and stipend of CCWs and enhanced supervision of CCWs to provide comprehensive TB-HIV/PMTCT services in a rural South African district . A before and after study design was used with a household survey to assess the operational effectiveness of the intervention . Six clusters were r and omised into intervention and control arms . Quantitative data were analysed using logistic regression , adjusting for cluster design . RESULTS Logistic regression analyses of the survey data show that CCWs from the intervention arm performed better in the provision of TB-HIV/PMTCT services , such as screening for TB and sexually transmitted infections , adherence to anti-tuberculosis treatment and antiretroviral therapy and counselling on infant feeding compared to the control CCWs ( P < 0.05 ) . However , intervention CCWs performed worse in the integrated management of childhood illnesses education and social welfare referrals ( P < 0.05 ) . The uptake of HIV testing increased significantly in the intervention arm , from 55 % to 78 % ( P < 0.001 ) . CONCLUSION The intervention was effective in enhancing the provision of community-based TB-HIV and PMTCT services . However , attention to other primary health care services is required to ensure that all key services are provided BACKGROUND Evidence suggests that community-based interventions that promote improved home-based practice s and care-seeking behaviour can have a large impact on maternal and child mortality in regions where rates are high . We aim ed to assess whether an intervention package based on the WHO Integrated Management of Childhood Illness h and book and community mobilisation could reduce under-5 mortality in rural Guinea-Bissau , where the health service infrastructure is weak . METHODS We did a non-masked cluster-r and omised controlled trial ( EPICS ) in the districts of Tombali and Quinara in Guinea-Bissau . Clusters of rural villages were stratified by ethnicity and distance from a regional health centre , and r and omly assigned ( 1:1 ) to intervention or control using a computerised r and om number generator . Women were eligible if they lived in one of the clusters at baseline survey prior to r and omisation and if they were aged 15 - 49 years or were primary caregivers of children younger than 5 years . Their children were eligible if they were younger than 5 years or were liveborn after intervention services could be implemented on July 1 , 2008 . In villages receiving the intervention , community health clubs were established , community health workers were trained in case management , and traditional birth attendants were trained to care for pregnant women and newborn babies , and promote facility-based delivery . Registered nurses supervised community health workers and offered mobile clinic services . Health centres were not improved . The control group received usual services . The primary outcome was the proportion of children dying under age 5 years , and was analysed in all eligible children up to final visits to villages between Jan 1 and March 31 , 2011 . This trial is registered with IS RCT N , number IS RCT N52433336 . FINDINGS On Aug 30 , 2007 , we r and omly assigned 146 clusters to intervention ( 73 clusters , 5669 women , and 4573 children ) or control ( 73 clusters , 5840 women , and 4675 children ) . From r and omisation until the end of the trial ( last visit by June 30 , 2011 ) , the intervention clusters had 3093 livebirths and the control clusters had 3194 . 6729 children in the intervention group and 6894 in the control group aged 0 - 5 years on July 1 , 2008 , or liveborn subsequently were analysed for mortality outcomes . 311 ( 4·6 % ) of 6729 children younger than 5 years died in the intervention group compared with 273 ( 4·0 % ) of 6894 in the control group ( relative risk 1·16 [ 95 % CI 0·99 - 1·37 ] ) . INTERPRETATION Our package of community-based interventions did not reduce under-5 mortality in rural Guinea-Bissau . The short timeframe and other trial limitations might have affected our results . Community-based health promotion and basic first-line services in fragile context s with weak secondary health service infrastructure might be insufficient to reduce child deaths . FUNDING Effective Intervention Objective To evaluate the Indian Integrated Management of Neonatal and Childhood Illness ( IMNCI ) programme , which integrates improved treatment of illness for children with home visits for newborn care , to inform its scale-up . Design Cluster r and omised trial . Setting 18 clusters ( population 1.1 million ) in Haryana , India . Participants 29 667 births in intervention clusters and 30 813 in control clusters . Intervention Community health workers were trained to conduct postnatal home visits and women ’s group meetings ; physicians , nurses , and community health workers were trained to treat or refer sick newborns and children ; supply of drugs and supervision were strengthened . Main outcome measures Neonatal and infant mortality ; newborn care practice s. Results The infant mortality rate ( adjusted hazard ratio 0.85 , 95 % confidence interval 0.77 to 0.94 ) and the neonatal mortality rate beyond the first 24 hours ( adjusted hazard ratio 0.86 , 0.79 to 0.95 ) were significantly lower in the intervention clusters than in control clusters . The adjusted hazard ratio for neonatal mortality rate was 0.91 ( 0.80 to 1.03 ) . A significant interaction was found between the place of birth and the effect of the intervention for all mortality outcomes except post-neonatal mortality rate . The neonatal mortality rate was significantly lower in the intervention clusters in the subgroup born at home ( adjusted hazard ratio 0.80 , 0.68 to 0.93 ) but not in the subgroup born in a health facility ( 1.06 , 0.
Output:
| Conclusion Proactive case detection may provide promising benefits for child health , but evidence is insufficient to draw conclusions . |
MS213444 | ***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 — Recent innovations such as CT installation in ambulances may lead to earlier start of stroke-specific treatments . However , such technically complex mobile facilities require effective methods of correctly identifying patients before deployment . We aim ed to develop and vali date a new dispatcher identification algorithm for stroke emergencies . Methods — Dispatcher identification algorithm for stroke emergencies was informed by systematic qualitative analysis of the content of emergency calls to ambulance dispatchers for patients with stroke or transient ischemic attack ( N=117 ) and other neurological ( N=39 ) and nonneurological ( N=51 ) diseases ( Part A ) . After training of dispatchers , sensitivity and predictive values were determined prospect ively in patients admitted to Charité hospitals by using the discharge diagnosis as reference st and ard ( Part B ) . Results — Part A : Dysphasic/dysarthric symptoms ( 33 % ) , unilateral symptoms ( 22 % ) and explicitly stated suspicion of stroke ( 47 % ) were typically identified in patients with stroke but infrequently in nonstroke cases ( all < 10 % ) . Convulsive symptoms ( 41 % ) were frequent in other neurological diseases but not strokes ( 3 % ) . Pain ( 26 % ) and breathlessness ( 31 % ) were often expressed in nonneurological emergencies ( 6 % and 7 % in strokes ) . Part B : Between October 15 and December 16 , 2010 , 5774 patients were admitted by ambulance with 246 coded with final stroke diagnoses . Sensitivity of dispatcher identification algorithm for stroke emergencies for detecting stroke was 53.3 % and positive predictive value was 47.8 % for stroke and 59.1 % for stroke and transient ischemic attack . Of all 275 patients with stroke dispatcher codes , 215 ( 78.5 % ) were confirmed with neurological diagnosis . Conclusions — Using dispatcher identification algorithm for stroke emergencies , more than half of all patients with stroke admitted by ambulance were correctly identified by dispatchers . Most false-positive stroke codes had other neurological diagnoses Purpose — The aim of this guideline is to provide a focused up date of the current recommendations for the endovascular treatment of acute ischemic stroke . When there is overlap , the recommendations made here supersede those of previous guidelines . Methods — This focused up date analyzes results from 8 r and omized , clinical trials of endovascular treatment and other relevant data published since 2013 . It is not intended to be a complete literature review from the date of the previous guideline publication but rather to include pivotal new evidence that justifies changes in current recommendations . Members of the writing committee were appointed by the American Heart Association/American Stroke Association Stroke Council ’s Scientific Statement Oversight Committee and the American Heart Association/American Stroke Association Manuscript Oversight Committee . Strict adherence to the American Heart Association conflict of interest policy was maintained throughout the consensus process . Recommendations follow the American Heart Association/American Stroke Association methods of classifying the level of certainty of the treatment effect and the class of evidence . Prerelease review of the draft guideline was performed by 6 expert peer review ers and by the members of the Stroke Council Scientific Statement Oversight Committee and Stroke Council Leadership Committee . Results — Evidence -based guidelines are presented for the selection of patients with acute ischemic stroke for endovascular treatment , for the endovascular procedure , and for systems of care to facilitate endovascular treatment . Conclusions — Certain endovascular procedures have been demonstrated to provide clinical benefit in selected patients with acute ischemic stroke . Systems of care should be organized to facilitate the delivery of this care Background and Purpose — Emergency medical dispatchers play an important role in optimizing stroke care if they are able to accurately identify calls regarding acute cerebrovascular disease . This study was undertaken to assess the diagnostic accuracy of the current national protocol guiding dispatcher question ing of 911 callers to identify stroke ( QA Guide version 11.1 of the National Academy Medical Priority Dispatch System ) . Methods — We identified all Los Angeles Fire Department paramedic transports of patients to University of California Los Angeles Medical Center during the 12-month period from January to December 2005 in a prospect ively maintained data base . Dispatcher-assigned Medical Priority Dispatch System codes for each of these patient transports were abstract ed from the paramedic run sheets and compared to final hospital discharge diagnosis . Results — Among 3474 transported patients , 96 ( 2.8 % ) had a final diagnosis of stroke or transient ischemic attack . Dispatchers assigned a code of potential stroke to 44.8 % of patients with a final discharge diagnosis of stroke or TIA . Dispatcher identification of stroke showed a sensitivity of 0.41 , specificity of 0.96 , positive predictive value of 0.45 , and negative predictive value of 0.95 . Conclusions — Dispatcher recognition of stroke calls using the widely employed Medical Priority Dispatch System algorithm is suboptimal , with failure to identify more than half of stroke patients as likely stroke . Revisions to the current national dispatcher structured interview and symptom identification algorithm for stroke may facilitate more accurate recognition of stroke by emergency medical dispatchers OBJECTIVE Early stroke recognition optimizes patients ' opportunities to benefit from therapeutic options . Prehospital stroke recognition is suboptimal . If 9 - 1 - 1 dispatchers used stroke- identification tools , prehospital stroke recognition might occur more rapidly and accurately . The Cincinnati Prehospital Stroke Scale ( CPSS ) is a brief , effective tool used by emergency medical services and hospital personnel to identify stroke . The study 's goal was to determine whether laypersons could be instructed to use the CPSS over the telephone . METHODS Adult visitors ( laypersons ) to a tertiary care emergency department were enrolled . Using a mock patient , laypersons were instructed to use the CPSS via telephone by an investigator simulating a 9 - 1 - 1 dispatcher . The patient r and omly portrayed clinical ly normal and abnormal patient types . The layperson 's ability to convey CPSS instructions to the patient and relay findings to the investigator was scored . RESULTS Seventy laypersons were enrolled ( 35 each for normal and abnormal patient types ) . Average age was 48 years , 63 % were female , and 40 % never attended college . Facial droop and speech instructions were administered with 100 % accuracy . Arm drift instructions were administered with 99 % accuracy . Layperson accuracies for interpreting findings were 93 % for facial droop , 93 % for arm drift , and 97 % for speech . Overall , stroke symptoms were detected with 94 % sensitivity ( 95 % CI 87 , 100 ) and 83 % specificity ( 95 % CI 70 , 95 ) . CONCLUSION Laypersons correctly administered and interpreted the CPSS when directed to do so over the telephone by a trained investigator . These findings suggest that the CPSS may be a useful tool in early prehospital detection of stroke by dispatchers BACKGROUND A number of emergency medical services ( EMSs ) performance measures for stroke have been proposed to promote early stroke recognition and rapid transportation to definitive care . This study examined performance measure compliance among EMS-transported stroke patients and the relationship between compliance and in-hospital stroke response . METHODS Eight quality indicators were derived from American Stroke Association guidelines . A prospect i ve cohort of consecutive , EMS-transported patients discharged from 2 large Midwestern stroke centers with a diagnosis of acute ischemic stroke was identified . Data were abstract ed from hospital and EMS records . Compliance with 8 prehospital quality indicators was calculated . Univariate and multivariable logistic regression analysis were performed to measure the association between prehospital compliance and a binary outcome of door-to-computed tomography ( CT ) time less than or equal to 25 minutes . RESULTS Over the 12 month study period , 186 EMS-transported ischemic stroke patients were identified . Compliance was highest for prehospital documentation of a glucose level ( 86.0 % ) and stroke screen ( 78.5 % ) and lowest for on-scene time less than or equal to 15 minutes ( 46.8 % ) , hospital prenotification ( 56.5 % ) , and transportation at highest priority ( 55.4 % ) . After adjustment for age , time from symptom onset , and stroke severity , transportation at highest priority ( odds ratio [ OR ] , 13.45 ) and hospital prenotification ( OR , 3.75 ) were both associated with significantly faster door-to-CT time . No prehospital quality metric was associated with tissue-plasminogen activator delivery . CONCLUSIONS EMS transportation at highest priority and hospital prenotification were associated with faster in-hospital stroke response and represent logical targets for EMS quality improvement efforts
Output:
| Conclusion : Even when utilizing a stroke screening tool , the accuracy of stroke recognition by emergency dispatchers was suboptimal . |
MS213445 | ***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 know the effectiveness and tolerance of weekly cisplatin added to radiotherapy ( RT ) in advanced carcinoma of oropharynx and nasopharynx . PATIENTS AND METHODS Stage II-IV cancer patients were r and omly assigned to either radical RT , 70 Gy/35 fractions over 7 weeks ( RT arm ) , or chemoradiotherapy ( CRT ) , cisplatin 40 mg/m² weekly for seven doses plus RT . Primary end points were ( i ) the responses , ( ii ) toxicity profile , and ( iii ) overall survival ( OS ) in two groups . Study period was from June 2003 to July 2005 . RESULTS One hundred and fifty-three patients were r and omly allocated to the study , 76 in RT arm and 77 in CRT arm . Seventy-one in each arm completed the planned treatment ; complete response ( CR ) : 67.1 % versus 80.5 % in RT and CRT arms ( P = 0.04 ) . Grade III and IV toxicity were 16 % and 40 % in RT and CRT arms , respectively ( P = 0.01 ) . There were frequent treatment interruptions ( 9.3 % versus 28.9 % ; P = 0.003 ) and hospitalization ( 20 % versus 40.8 % ) in the CRT group . OS was superior in the CRT arm ( P = 0.02 ) : 27 months [ 95 % confidence interval ( CI ) 15.2 - 36.8 ] for RT versus not reached for CRT . Three-year OS was 42 % for RT and 62 % for CRT group . CRT and CR were independent prognostic factors . CONCLUSION This trial on Indian head and neck squamous cell carcinoma patients confirms that the use of weekly cisplatin is safe and CRT is superior to RT alone result ing in higher OS 5555 Background : In loco-regionally advanced head and neck squamous cell cancer ( HNSCC ) , concurrent 3-weekly cisplatin improves the overall survival ( OS ) of patients compared to radiotherapy ( RT ) alone , but is often associated with renal toxicity . METHODS Retrospective analysis of treatment outcome and nephrotoxicity frequency of intensity-modulated radiotherapy ( IMRT ) associated with either 3-weekly ( 100 mg/m2 on day 1 , 22 , 43 ) or weekly cisplatin ( 40 mg/m2 on day 1 , 8 , 15 , 22 , 29 , 36 , 43 ) in 94 patients with stage III/IV HNSCC . RESULTS Patients treated with weekly cisplatin ( N=40 ) were significantly older ( median age 65 vs. 58 years , p=0.0014 ) and received a significantly lower total cisplatin dose ( median 186 mg/m2 vs. 228 mg/m2 , p=0.0002 ) and these differences have likely contributed to the clinical outcome . At a median follow up of 2.8 years , the median progression-free survival ( PFS ) was 1.5 years with weekly and 2.1 years with 3-weekly cisplatin ( p= 0.47 ) . OS was significantly longer ( 4.3 vs. 1.9 years , p= 0.041 ) in patients treated with the 3-weekly regimen ( N=54 ) ; indeed cisplatin doses > 360 mg total or > 240 mg/m2 were associated with better OS but not better PFS . At univariate analysis , a history of alcohol abuse and /or smoking was associated with worse PFS ( p=0.013 ) . Multivariate analysis confirmed the impact of alcohol and smoking habits on both PFS and OS , while the treatment schedule only affected OS . Acute renal failure rate was 35 % with the weekly and 54 % with the 3-weekly regime ( p=0.07 ) ; chronic renal failure rate was 5 % and 30 % , respectively ( p=0.04 ) . No patient required renal replacement therapy . CONCLUSIONS Both schedules can be combined to IMRT , but weekly cisplatin is less nephrotoxic . PFS was not significantly different despite patients treated with the weekly schedule being significantly older and under-treated . The study suggests that cisplatin schedule may not be relevant when combined to IMRT . Controlled prospect i ve studies are needed to compare the clinical activity of different cisplatin schedules in combination with IMRT Background The aim of this study was to compare the outcomes of postoperative adjuvant concomitant chemoradiotherapy using two different schedules of cisplatin for patients with high-risk oral squamous cell carcinoma ( OSCC ) . Methods From Feb. 2008 to Aug. 2010 , 55 patients with high-risk OSCC were included in this study . Patients were r and omized into treatment groups that either received 100 mg/m2 cisplatin once every 3 weeks ( arm A ) or 40 mg/m2 cisplatin once per week ( arm B ) . All patients were irradiated with 66 Gy in 33 fractions . Results Of the 50 eligible patients , 26 were assigned to arm A , and 24 were assigned to arm B. Both groups of patients received the same mean doses of radiotherapy and cisplatin . However , 88.5 % of patients in arm A and 62.5 % of those in arm B ( p = 0.047 ) received ≥ 200 mg/m2 of cisplatin in total . The overall toxicity was significantly greater in arm B ( p = 0.020 ) , and all of the grade 4 toxicities occurred in patients in arm B. Conclusions Three-weekly high-dose cisplatin treatment showed higher compliance , and lower acute toxicity compared to weekly low-dose cisplatin treatment PURPOSE Although p16 protein expression , a surrogate marker of oncogenic human papillomavirus ( HPV ) infection , is recognized as a prognostic marker in oropharyngeal squamous cell carcinoma ( OPSCC ) , its prevalence and significance have not been well established in cancer of the oral cavity , hypopharynx , or larynx , collectively referred as non-OPSCC , where HPV infection is less common than in the oropharynx . PATIENTS AND METHODS p16 expression and high-risk HPV status in non-OPSCCs from RTOG 0129 , 0234 , and 0522 studies were determined by immunohistochemistry ( IHC ) and in situ hybridization ( ISH ) . Hazard ratios from Cox models were expressed as positive or negative , stratified by trial , and adjusted for clinical characteristics . RESULTS p16 expression was positive in 14.1 % ( 12 of 85 ) , 24.2 % ( 23 of 95 ) , and 19.0 % ( 27 of 142 ) and HPV ISH was positive in 6.5 % ( six of 93 ) , 14.6 % ( 15 of 103 ) , and 6.9 % ( seven of 101 ) of non-OPSCCs from RTOG 0129 , 0234 , and 0522 studies , respectively . Hazard ratios for p16 expression were 0.63 ( 95 % CI , 0.42 to 0.95 ; P = .03 ) and 0.56 ( 95 % CI , 0.35 to 0.89 ; P = .01 ) for progression-free ( PFS ) and overall survival ( OS ) , respectively . Comparing OPSCC and non-OPSCC , patients with p16-positive OPSCC have better PFS and OS than patients with p16-positive non-OPSCC , but patients with p16-negative OPSCC and non-OPSCC have similar outcomes . CONCLUSION Similar to results in patients with OPSCC , patients with p16-negative non-OPSCC have worse outcomes than patients with p16-positive non-OPSCC , and HPV may also have a role in outcome in a subset of non-OPSCC . However , further development of a p16 IHC scoring system in non-OPSCC and improvement of HPV detection methods are warranted before broad application in the clinical setting PURPOSE Previous analysis of this Intergroup trial demonstrated that with a median follow-up among surviving patients of 45.9 months , the concurrent postoperative administration of cisplatin and radiation therapy improved local-regional control and disease-free survival of patients who had high-risk resectable head- and -neck carcinomas . With a minimum of 10 years of follow-up potentially now available for all patients , these results are up date d here to examine long-term outcomes . METHODS AND MATERIAL S A total of 410 analyzable patients who had high-risk resected head- and -neck cancers were prospect ively r and omized to receive either radiation therapy ( RT : 60 Gy in 6 weeks ) or identical RT plus cisplatin , 100 mg/m(2)i.v . on days 1 , 22 , and 43 ( RT + CT ) . RESULTS At 10 years , the local-regional failure rates were 28.8 % vs 22.3 % ( P=.10 ) , disease-free survival was 19.1 % vs 20.1 % ( P=.25 ) , and overall survival was 27.0 % vs 29.1 % ( P=.31 ) for patients treated by RT vs RT + CT , respectively . In the unplanned subset analysis limited to patients who had microscopically involved resection margins and /or extracapsular spread of disease , local-regional failure occurred in 33.1 % vs 21.0 % ( P=.02 ) , disease-free survival was 12.3 % vs 18.4 % ( P=.05 ) , and overall survival was 19.6 % vs 27.1 % ( P=.07 ) , respectively . CONCLUSION At a median follow-up of 9.4 years for surviving patients , no significant differences in outcome were observed in the analysis of all r and omized eligible patients . However , analysis of the subgroup of patients who had either microscopically involved resection margins and /or extracapsular spread of disease showed improved local-regional control and disease-free survival with concurrent administration of chemotherapy . The remaining subgroup of patients who were enrolled only because they had tumor in 2 or more lymph nodes did not benefit from the addition of CT to RT Background The dominant pattern of failure for squamous cell carcinoma of head and neck remains loco-regional , although distant metastases are now being increasingly documented . Radical radiotherapy with concurrent chemotherapy is contemporary st and ard of care in the non-surgical management of these loco-regionally advanced cancers , based on large r and omized controlled trials utilizing high-dose cisplatin ( 80–100 mg/m2 ) cycled every three-weekly during definitive radiotherapy . Although efficacious , this is associated with high acute morbidity necessitating intensive supportive care with attendant re source implication s. The aim of this retrospective study was to assess the efficacy and acute toxicity of an alternative schedule i.e. concurrent weekly cisplatin-based radical radiotherapy and it 's potential to be an optimal regimen in advanced head and neck cancers . Methods Outcome data of patients with Stage III & IV head and neck squamous cell carcinoma , excluding nasopharynx , planned for radical radiotherapy ( 66–70 Gy ) with concurrent weekly cisplatin ( 30 mg/m2 ) treated in a single unit between 1996–2004 was extracted . Results The data set consisted of 264 patients with a median age of 54 years . The median radiotherapy dose was 70 Gy ( range 7.2–72 Gy ) and median number of chemotherapy cycles was 6 ( range 1–7 ) . Two-thirds ( 65 % ) of patients received ≥85 % of planned cisplatin dose . With a mean follow-up of 19 months , the 5-year local control ; loco-regional control ; and disease free survival was 57 % ; 46 % ; and 43 % respectively . Acute grade 3 or worse mucositis and dermatitis was seen in 77 ( 29 % ) and 92 ( 35 % ) patients respectively , essentially in patients receiving doses ≥66 Gy and 6 or more cycles of chemotherapy . Other toxicities ( hematologic , nausea and vomiting ) were mild and self-limiting . Overall , the acute toxicity of this concurrent weekly chemo-radiation regimen though mildly increased did not m and ate intensive supportive care . Stage grouping , primary site , and intensity of treatment were significant predictors of loco-regional control and disease free survival . Conclusion Radical radiotherapy with concurrent weekly cisplatin has moderate efficacy and acceptable acute toxicity with potential to be an optimal regimen in loco-regionally advanced squamous cell carcinoma of the head and neck , particularly in limited-re source setting s. Stage grouping , primary site , and treatment intensity are important determinants of outcome BACKGROUND We compared concomitant cisplatin and irradiation with radiotherapy alone as adjuvant treatment for stage III or IV head and neck cancer . METHODS After undergoing surgery with curative intent , 167 patients were r and omly assigned to receive radiotherapy alone ( 66 Gy over a period of 6 1/2 weeks ) and 167 to receive the same radiotherapy regimen combined with 100 mg of cisplatin per square meter of body-surface area
Output:
| Results support the conclusion that the cumulative dose of cisplatin in concurrent chemoradiation protocol s for HNSCC has a significant positive correlation with survival . |
MS213446 | ***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: Long-term effects of multisensory stimulation were assessed using a “ Snoezelen ” room on older residents with dementia . Thirty patients were r and omly assigned to 3 groups : multisensory stimulation environment ( MSSE ) group , individualized activities ( activity ) group , and control group . The MSSE and activity groups participated in two 30-minute weekly individualized intervention sessions over 16 weeks . Pre- , mid- , posttrial , and 8-week follow-up behavior , mood , cognitive , and functional impairment in basic activities of daily living were registered . Items included in the physically nonaggressive behavior factor improved significantly in post- versus pretrial in the MSSE group compared to the activity group , with no significant differences between MSSE and control groups . The MSSE and activity groups demonstrated behavior improvements and higher scores on the Cohen-Mansfield agitation inventory , verbal agitated behavior factor , and Neuropsychiatric Inventory – Nursing Home , with no significant differences between groups . The MSSE could have long-term positive effects on such neuropsychiatric symptoms in older people with dementia CONTEXT Optimal treatment to postpone functional decline in patients with dementia is not established . OBJECTIVE To test a nonpharmacologic intervention realigning environmental dem and s with patient capabilities . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve 2-group r and omized trial ( Care of Persons with Dementia in their Environments [ COPE ] ) involving patients with dementia and family caregivers ( community-living dyads ) recruited from March 2006 through June 2008 in Pennsylvania . INTERVENTIONS Up to 12 home or telephone contacts over 4 months by health professionals who assessed patient capabilities and deficits ; obtained blood and urine sample s ; and trained families in home safety , simplifying tasks , and stress reduction . Control group caregivers received 3 telephone calls and educational material s. MAIN OUTCOME MEASURES Functional dependence , quality of life , frequency of agitated behaviors , and engagement for patients and well-being , confidence using activities , and perceived benefits for caregivers at 4 months . RESULTS Of 284 dyads screened , 270 ( 95 % ) were eligible and 237 ( 88 % ) r and omized . Data were collected from 209 dyads ( 88 % ) at 4 months and 173 ( 73 % ) at 9 months . At 4 months , compared with controls , COPE patients had less functional dependence ( adjusted mean difference , 0.24 ; 95 % CI , 0.03 - 0.44 ; P = .02 ; Cohen d = 0.21 ) and less dependence in instrumental activities of daily living ( adjusted mean difference , 0.32 ; 95 % CI , 0.09 - 0.55 ; P = .007 ; Cohen d = 0.43 ) , measured by a 15-item scale modeled after the Functional Independence Measure ; COPE patients also had improved engagement ( adjusted mean difference , 0.12 ; 95 % CI , 0.07 - 0.22 ; P = .03 ; Cohen d = 0.26 ) , measured by a 5-item scale . COPE caregivers improved in their well-being ( adjusted mean difference in Perceived Change Index , 0.22 ; 95 % CI , 0.08 - 0.36 ; P = .002 ; Cohen d = 0.30 ) and confidence using activities ( adjusted mean difference , 0.81 ; 95 % CI , 0.30 - 1.32 ; P = .002 ; Cohen d = 0.54 ) , measured by a 5-item scale . By 4 months , 64 COPE dyads ( 62.7 % ) vs 48 control group dyads ( 44.9 % ) eliminated 1 or more caregiver-identified problems ( chi(2/1 ) = 6.72 , P = . 01 ) . CONCLUSION Among community-living dyads , a nonpharmacologic biobehavioral environmental intervention compared with control result ed in better outcomes for COPE dyads at 4 months . Although no group differences were observed at 9 months for patients , COPE caregivers perceived greater benefits . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00259454 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 , -0.10 to -1.00 ) and negative affect ( 0.8 points ; 95 % CI , 0.20 - 1.44 ) . Melatonin also increased withdrawn behavior by 1.02 points ( 95 % CI , 0.18 - 1.86 ) on the Multi Observational Scale for Elderly Subjects scale , although this effect was not seen if given in combination with light . Combined treatment also attenuated aggressive behavior by 3.9 points ( 95 % CI , 0.88 - 6.92 ) on the Cohen-Mansfield Agitation Index or 9 % , increased sleep efficiency by 3.5 % ( 95 % CI , 0.8%-6.1 % ) , and improved nocturnal restlessness by 1.00 minute per hour each year ( 95 % CI , 0.26 - 1.78 ) or 9 % ( treatment x time effect ) . CONCLUSIONS Light has a modest benefit in improving some cognitive and noncognitive symptoms of dementia . To counteract the adverse effect of melatonin on mood , it is recommended only in combination with light . TRIAL REGISTRATION controlled-trials.com/is rct n Identifier : IS RCT N93133646 Background / Aims : Behavioural and psychological symptoms ( BPSD ) are frequent in people with Alzheimer ’s disease and cause considerable stress to patients and their carers . Antipsychotics have been widely used as a first-line treatment , result ing in an estimated 1,800 excess strokes and 1,600 excess deaths in the UK alone . Safe and effective alternatives are urgently needed . Based upon preliminary evidence from clinical trials , aromatherapy with melissa oil may be such an alternative , but initial studies have been modest in size , and adequate blinding has been problematic . Our objective was to assess the efficacy of melissa aromatherapy in the treatment of agitation in people with Alzheimer ’s disease in an adequately powered and robustly blinded r and omized controlled trial comparing it with donepezil , an anticholinesterase drug used with some benefit to treat BPSD . Methods and Findings : The study was a double-blind parallel-group placebo-controlled r and omized trial across 3 specialist old age psychiatry centres in Engl and . Participants had probable or possible Alzheimer ’s disease , were resident in a care home , had clinical ly significant agitation ( defined as a score of 39 or above on the Cohen Mansfield Agitation Inventory ) and were free of antipsychotics and /or anticholinesterase for at least 2 weeks . Participants were allocated to 1 of 3 groups : placebo medication and active aromatherapy ; active medication and placebo aromatherapy or placebo of both . Main Outcome : The primary outcome measure was reduction in agitation as assessed by the Pittsburgh Agitation Scale ( PAS ) at 4 weeks . This is an observational scale , and raters were required to wear nose clips to ensure that full blinding was maintained . The PAS , Neuropsychiatric Inventory ( NPI ; another measure of BPSD ) and other outcome measures were completed at baseline , 4-week and 12-week follow-ups . 114 participants were r and omized , of whom 94 completed the week 4 assessment and 81 completed the week 12 assessment . Aromatherapy and donepezil were well tolerated . There were no significant differences between aromatherapy , donepezil and placebo at week 4 and week 12 , but importantly there were substantial improvements in all 3 groups with an 18 % improvement in the PAS and a 37 % improvement in the NPI over 12 weeks . Conclusion : When assessed using a rigorous design which ensures blinding of treatment arms , there is no evidence that melissa aromatherapy is superior to placebo or donepezil , in the treatment of agitation in people with Alzheimer ’s disease . However , the sizeable improvement in the placebo group emphasizes the potential non-specific benefits of touch and interaction in the treatment of agitation in people with Alzheimer ’s disease OBJECTIVES A series of pre clinical studies have suggested that selective serotonin reuptake inhibitor antidepressants not only stimulate neurogenesis but also have neuroprotective effects . The present study primarily aim ed to investigate whether escitalopram would decelerate the brain atrophy of patients with mild-to-moderate Alzheimer 's disease ( AD ) . We also assessed the effects of escitalopram on the cognitive function and neuropsychiatric symptoms of these participants . METHODS Seventy-four probable AD patients without major depression were recruited from four dementia clinics of university hospitals and r and omly assigned in a 1:1 ratio . Each group received 20 mg/day of escitalopram or placebo for 52 weeks . The primary outcome measures were the change rates of hippocampal and whole brain volume on magnetic resonance imaging for 52 weeks . The Alzheimer 's Disease Assessment Scale-cognitive subscale , Mini-Mental State Examination , Neuropsychiatric Inventory , and Cornell Scale for Depression in Dementia ( CSDD ) were also applied . RESULTS We did not find any significant differences in the changes of hippocampal or whole brain volume between the groups . Escitalopram showed significant beneficial effects on the CSDD score at 28 weeks compared with placebo ( t = -2.17 , df = 50.42 , p = 0.035 ) , but this finding did not persist throughout the study . CONCLUSION The findings of the present study do not support the role of escitalopram as a progression-delaying treatment for AD . However , the negative results of the present trial should be interpreted cautiously because of the relatively small sample size . Further large-scale escitalopram trials targeting the earlier stages of AD , even prodromal AD , are still needed . Copyright © 2015 John Wiley & Sons , Objective : To assess the impact and the social rating of an active music condition ( in which 10 patients with Alzheimer 's disease regulated their music input ) vs. a passive music condition . Method : In the active condition , the patients used a simple h and response and a microswitch to activate music stimulation periods . In the passive condition , music stimulation was prearranged and continued through the sessions . The active and passive stimulation sessions were preceded and followed by control ( non-stimulation ) sessions . Results : The active condition sessions showed an increase in the patients ’ indices of positive participation ( e.g. , singing or music-related movements , and smiles ) similar to that observed in the passive condition sessions . Social raters ( 140 psychology students ) favored the active condition on a six-item question naire dealing , among others , with conditions ’ suitability , respect of patients ’ dignity and independence , and practicality . Conclusion : An active music stimulation condition can be viable , effective , and socially preferable BACKGROUND Agitation is common in people with dementia , is distressing to patients and stressful to their carers . Drugs used to treat the
Output:
| Strong evidence indicates that person-centered approaches can improve behavior .
Moderate evidence supports noise regulation , environmental design , unobtrusive visual barriers , and environmental relocation strategies to reduce problematic behaviors .
Evidence is insufficient for the effectiveness of mealtime ambient music , bright light , proprioceptive input , w and er gardens , optical strategies , and sensory devices in improving behavior or reducing w and ering and falls . |
MS213447 | ***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 / OBJECTIVES To evaluate the effects of 10 weeks of aerobic exercise on depressive and anxiety symptoms and self-esteem of breast cancer survivors . DESIGN Experimental , crossover . SETTING Midwestern university town . SAMPLE Twenty-four breast cancer survivors ( mean time following surgery 41.8 months ; ranging from 1 to 99 months ) recruited via mail and cancer support groups . The mean age of the sample was 48.9 years . METHODS Subjects were assigned r and omly into exercise ( EX ) , exercise-plus-behavior modification ( EX + BM ) , and control groups . EX and EX + BM groups exercised aerobically four days/week at > or = 60 % of age-predicted maximum heart rate for 10 weeks . Data were collected pretest , post-test , and crossover ( 12 weeks following post-test ) . Because pretest or post-test scores showed no statistical differences between EX and EX + BM groups , data were combined to form one group . MAIN RESEARCH VARIABLES Aerobic exercise ( four days/ week ; 30 - 40 minutes/session ) , depression , ( Beck Depression inventory ) , anxiety ( Speilberger State-Trait Anxiety Inventory ) , and self-esteem ( Rosenberg Self-Esteem Inventory ) . FINDINGS Pre- to post-test analyses revealed that women who exercised had significantly less depression and state and trait anxiety over time compared to controls . After the crossover , the control group demonstrated comparable improvements in both depressive and state anxiety scores . Self-esteem did not change significantly . Subjects who received exercise recommendations from their physicians exercised significantly more than subjects who received no recommendation . CONCLUSIONS Mild to moderate aerobic exercise may be of therapeutic value to breast cancer survivors with respect to depressive and anxiety symptoms but not to self-esteem . A physician 's recommendation to exercise appears to be an important factor in a patient 's exercise adherence . IMPLICATION S FOR NURSING PRACTICE To Improve depressive and anxiety symptoms following breast cancer surgery , healthcare professionals should consider recommending mild to moderate exercise Goals of workProstate cancer patients receiving and rogen deprivation therapy ( ADT ) are vulnerable to a number of potentially debilitating side effects , which can significantly impact quality of life . The role of alternate therapies , such as physical activity ( PA ) , in attenuating these side effects is largely understudied for such a large population . Thus , the purpose of this study was to investigate the effects of PA intervention for men receiving ADT on PA behavior , quality of life , and fitness measures . Patients and methods One hundred participants were r and omized into an intervention ( n = 53 ) or a wait-list control group ( n = 47 ) , with 11 dropping out of the intervention group and 23 dropping out of the wait-list control group prior to post-testing . The intervention consisted of both an individually tailored home-based aerobic and light resistant training program and weekly group sessions . PA , quality of life , fitness , and physiological outcomes were assessed pre and post the 16-week intervention . Results Significant increases in PA , supported by changes in girth measures and blood pressure , support the beneficial impact of the intervention . Positive trends were also evident for depression and fatigue . However , due to the high dropout rate , these results must be interpreted with caution . Conclusions PA effectively attenuates many of the side effects of ADT and should be recommended to prostate survivors as an alternate therapy . Determining the maintenance of this behavior change will be important for underst and ing how the long-term benefits of increased activity levels may alleviate the late effects of ADT Background : Few studies have evaluated an individualized home-based exercise prescription during and after cancer treatment . Objective : The purpose of this study was to evaluate the effectiveness of a home-based exercise training intervention , the Pro-self Fatigue Control Program on the management of cancer-related fatigue . Interventions / Methods : Participants ( N = 119 ) were r and omized into 1 of 3 groups : group 1 received the exercise prescription throughout the study ; group 2 received their exercise prescription after completing cancer treatment ; and group 3 received usual care . Patients completed the Piper Fatigue Scale , General Sleep Disturbance Scale , Center for Epidemiological Studies -Depression Scale , and Worst Pain Intensity Scale . Results : All groups reported mild fatigue levels , sleep disturbance , and mild pain , but not depression . Using multilevel regression analysis , significant linear and quadratic trends were found for change in fatigue and pain ( ie , scores increased , then decreased over time ) . No group differences were found in the changing scores over time . A significant quadratic effect for the trajectory of sleep disturbance was found , but no group differences were detected over time . No significant time or group effects were found for depression . Conclusions : Our home-based exercise intervention had no effect on fatigue or related symptoms associated with cancer treatment . The optimal timing of exercise remains to be determined . Implication s for Practice : Clinicians need to be aware that some physical activity is better than none , and there is no harm in exercise as tolerated during cancer treatment . Further analysis is needed to examine the adherence to exercise . More frequent assessment s of fatigue , sleep disturbance , depression , and pain may capture the effect of exercise OBJECTIVE To determine the effect of exercise on quality of life in ( a ) a r and omized controlled trial of exercise among recently diagnosed breast cancer survivors undergoing adjuvant therapy and ( b ) a similar trial among post-treatment survivors . METHODS Fifty newly diagnosed breast cancer survivors were recruited through a hospital-based tumor registry and r and omized to a 6-month , home-based exercise program ( n=25 ) or a usual care group ( n=25 ) . In a separate trial , 75 post-treatment survivors were r and omized to a 6-month , supervised exercise intervention ( n=37 ) or to usual care ( n=38 ) . Participants in both studies completed measures of happiness , depressive symptoms , anxiety , stress , self-esteem , and quality of life at baseline and 6 months . RESULTS Forty-five participants completed the trial for newly diagnosed survivors and 67 completed the trial for post-treatment survivors . Good adherence was observed in both studies . Baseline quality of life was similar for both studies on most measures . Exercise was not associated with quality of life benefits in the full sample of either study ; however exercise was associated with improved social functioning among post-treatment survivors who reported low social functioning at baseline ( p<0.05 ) . CONCLUSIONS Exercise did not affect quality of life in either recently diagnosed or post-treatment breast cancer survivors ; however this may be due in part to relatively high baseline functioning among participants in both studies . Strategies for future research include limiting enrollment to survivors who report reduced quality of life on screening question naires and targeting survivor subgroups known to be at particular risk for quality of life impairment Objectives . This study compares the effects of an integrated yoga program with brief supportive therapy in breast cancer out patients undergoing adjuvant radiotherapy at a cancer center . Methods . Eighty-eight stage II and III breast cancer out patients are r and omly assigned to receive yoga ( n = 44 ) or brief supportive therapy ( n = 44 ) prior to radiotherapy treatment . Assessment s include diurnal salivary cortisol levels 3 days before and after radiotherapy and self-ratings of anxiety , depression , and stress collected before and after 6 weeks of radiotherapy . Results . Analysis of covariance reveals significant decreases in anxiety ( P < .001 ) , depression ( P = .002 ) , perceived stress ( P < .001 ) , 6 a.m. salivary cortisol ( P = .009 ) , and pooled mean cortisol ( P = .03 ) in the yoga group compared with controls . There is a significant positive correlation between morning salivary cortisol level and anxiety and depression . Conclusion . Yoga might have a role in managing self-reported psychological distress and modulating circadian patterns of stress hormones in early breast cancer patients undergoing adjuvant radiotherapy Objectives To determine functional and psychological benefits of a 12 week supervised group exercise programme during treatment for early stage breast cancer , with six month follow-up . Design Pragmatic r and omised controlled prospect i ve open trial . Setting Three National Health Service oncology clinics in Scotl and and community exercise facilities . Participants 203 women entered the study ; 177 completed the six month follow-up . Interventions Supervised 12 week group exercise programme in addition to usual care , compared with usual care . Main outcome measures Functional assessment of cancer therapy ( FACT ) question naire , Beck depression inventory , positive and negative affect scale , body mass index , seven day recall of physical activity , 12 minute walk test , and assessment of shoulder mobility . Results Mixed effects models with adjustment for baseline values , study site , treatment at baseline , and age gave intervention effect estimates ( intervention minus control ) at 12 weeks of 129 ( 95 % confidence interval 83 to 176 ) for metres walked in 12 minutes , 182 ( 75 to 289 ) for minutes of moderate intensity activity reported in a week , 2.6 ( 1.6 to 3.7 ) for shoulder mobility , 2.5 ( 1.0 to 3.9 ) for breast cancer specific subscale of quality of life , and 4.0 ( 1.8 to 6.3 ) for positive mood . No significant effect was seen for general quality of life ( FACT-G ) , which was the primary outcome . At the six month follow-up , most of these effects were maintained and an intervention effect for breast cancer specific quality of life emerged . No adverse effects were noted . Conclusion Supervised group exercise provided functional and psychological benefit after a 12 week intervention and six months later . Clinicians should encourage activity for their patients . Policy makers should consider the inclusion of exercise opportunities in cancer rehabilitation services . Trial registration Current controlled trials IS RCT N12587864 PURPOSE To examine the effects of aerobic exercise therapy on quality of life ( QoL ) and associated outcomes in women treated for breast cancer . Evidence suggests that exercise may be beneficial , but no trial has included an exercise-placebo and a usual-care group to control for the attention effects that might be associated with aerobic exercise interventions in cancer patients . PATIENTS AND METHODS A total of 108 women who had been treated for breast cancer 12 to 36 months previously were r and omly assigned to supervised aerobic exercise therapy ( n = 34 ) , exercise-placebo ( body conditioning ; n = 36 ) , or usual care ( n = 38 ) . Exercise therapy and exercise-placebo sessions took place three times per week for 8 weeks . Outcomes included QoL , depression , exercise behavior , aerobic fitness ; outcomes were assessed at baseline and at the 8- and 24-week follow-up . RESULTS Analyses of covariance revealed a significant mean difference of 9.8 units in Functional Assessment of Cancer Therapy-General ( primary outcome ) favoring aerobic exercise therapy at 8 weeks , relative to usual care . Significant differences that favored aerobic exercise therapy relative to usual care were recorded for Functional Assessment of Cancer Therapy-Breast , social/family well-being , functional well-being , and breast cancer subscale scores at 8-week follow-up . Psychological health outcomes improved modestly for both intervention groups ; these improvements were sustained for several end points . CONCLUSION Exercise therapy had large , clinical ly meaningful , short-term beneficial effects on QoL in women treated for breast cancer ; this finding can not be attributable to attention , given that the exercise-placebo group did not report similar effects relative to usual care PURPOSE Breast cancer chemotherapy may cause unfavorable changes in physical functioning , body composition , psychosocial functioning , and quality of life ( QOL ) . We evaluated the relative merits of aerobic and resistance exercise in blunting these effects . PATIENTS AND METHODS We conducted a multicenter r and omized controlled trial in Canada between 2003 and 2005 that r and omly assigned 242 breast cancer patients initiating adjuvant chemotherapy to usual care ( n = 82 ) , supervised resistance exercise ( n = 82 ) , or supervised aerobic exercise ( n = 78 ) for the duration of their chemotherapy ( median , 17 weeks ; 95 % CI , 9 to 24 weeks ) . Our primary end point was cancer-specific QOL assessed by the Functional Assessment of Cancer Therapy-Anemia scale . Secondary end points were fatigue , psychosocial functioning , physical fitness , body composition , chemotherapy completion rate , and lymphedema . RESULTS The follow-up assessment rate for our primary end point was 92.1 % , and adherence to the supervised exercise was 70.2 % . Unadjusted and adjusted mixed-model analyses indicated that aerobic exercise was superior to usual care for improving self-esteem ( P = .015 ) , aerobic fitness ( P = .006 ) , and percent body fat ( adjusted P = .076 ) . Resistance exercise was superior to usual care for improving self-esteem ( P = .018 ) , muscular strength ( P < .001 ) , lean body mass ( P = .015 ) , and chemotherapy completion rate ( P = .033 ) . Changes in cancer-specific QOL , fatigue , depression , and anxiety favored the exercise groups but did not reach statistical significance . Exercise did not cause lymphedema or adverse events . CONCLUSION Neither aerobic nor resistance exercise significantly improved cancer-specific QOL in breast cancer patients receiving chemotherapy , but they did improve self-esteem , physical fitness , body composition , and chemotherapy completion rate without causing lymphedema or significant adverse events PURPOSE / OBJECTIVES To compare the effectiveness of a prescribed home-based
Output:
| CONCLUSIONS Exercise has modest positive effects on depressive symptoms with larger effects for programs that were supervised or partially supervised , not conducted at home , and at least 30 minutes in duration .
IMPACT Our results complement other studies showing that exercise is associated with reduced pain and fatigue and with improvements in quality of life among cancer survivors |
MS213448 | ***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 AIM While lispro insulin has been reported to lower postpr and ial blood glucose concentrations , less consistent effects have been shown for glycosylated hemoglobin ( HbA1c ) levels . Aim of this study was to determine whether pre-meal association of NPH , an intermediate-acting insulin , with lispro improves overall glycemic control in type 1 diabetic patients . METHODS AND RESULTS Eighty-five type 1 diabetic patients were studied in a multicenter r and omized comparative ( human regular vs lispro insulin ) crossover ( 3-month ) study in which NPH insulin was given as a dinner or bedtime injection and at breakfast and lunch if necessary . The number of injections was kept constant : 42 % and 58 % of patients injected insulin 3 and 4 times per day , respectively . Fasting and prepr and ial blood glucose levels were similar , while postpr and ial levels improved after lispro compared to human regular insulin ( breakfast : 8.28 + /- 2.39 vs 9.28 + /- 2.72 mmol/l ; lunch : 8.33 + /- 2.67 vs 9.06 + /- 2.67 mmol/l , dinner : 8.06 + /- 2.72 vs 9.28 + /- 2.44 mmol/l , ANOVA : p = 0.003 ) . HbA1c also improved after lispro : 8.1 + /- 0.9 vs 8.3 + /- 0.8 % , p < 0.05 . The rate of hypoglycemia was similar . Patients showed better acceptance of lispro treatment ( p < 0.001 ) . CONCLUSIONS Lispro improves overall blood glucose control in type 1 diabetic patients without increasing the incidence of hypoglycemia . This can be achieved by an optimal combination of lispro insulin with NPH whenever the time intervals between meals are too long Summary The objective of this study was to identify possible risk factors of severe hypoglycaemia ( SH ) in a prospect i ve population based study of adult Type I ( insulin-dependent ) diabetic patients . A representative sample of 684 patients ( 41 % women , mean ± SD age 36 ± 11 , diabetes duration 18 ± 11 years ) , living in the district of Northrhine ( 9.5 million inhabitants ) , Germany , were examined in their homes using a mobile ambulance . A comprehensive baseline assessment of possible predictors of SH included sociodemographic and disease related variables , hypoglycaemia awareness , diabetes management , and attitudes and behavioural aspects as expressed by the patients . After a mean of 19 ± 6 months 669 ( 98 % ) patients were interviewed about events of SH since the baseline examination . Using the multiple Cox proportional hazards model , five risk factors of SH were identified : SH during the preceding year [ hazard ratio ( HR ) 2.7 , 95 % confidence intervals ( CI ) 1.8–4.2 ] , any history of SH ( HR 1.9 , CI 1.1–3.4 ) , C-peptide negativity ( HR 4.0 , CI 1.2–12.7 ) , social status ( HR 0.8 for a difference of 5 units for a value range of 0–24 , CI 0.6–0.9 ) , and patients ' determination to reach normoglycaemia ( HR 0.7 for a difference of 1 unit for a value range of 1–6 , CI 0.5–0.9 ) , indicating that the lower the social status and the higher the patients ' determination to reach normoglycaemia , the higher the risk of SH . After eliminating the history of hypoglycaemia from the model , impaired hypoglycaemia awareness and patients ' inappropriate denial of SH as their particular problem became additional significant risk factors of SH . In conclusion , in this population based study of adult Type I diabetic patients , C-peptide negativity , a previous event of SH , patients ' determination to reach normoglycaemia and social class were risk factors of SH . [ Diabetologia ( 1998 ) 41 : 1274–1282 Insulin lispro is an insulin analogue that has the advantages of being fast-acting , convenient , and less likely to lead to hypoglycaemic episodes . Previous studies have proven its value in treating both Type 1 and Type 2 diabetes both alone and in combination with different treatment regimens.1,2 However , diabetes is heterogeneous and differs in etiology and clinical characteristics in different ethnic groups . Even with the same insulin treatment , different diets will produce different glycaemic profiles . Diet patterns differ between different ethnic groups . Traditional oriental foods are characterized by a higher proportion of carbohydrates and a lower proportion of fat compared to Caucasian diets . To date , there has been no study on the use of insulin lispro in Chinese diabetic patients . Whether the Chinese dietary pattern will affect the efficacy of insulin lispro treatment remains unknown . Therefore , we conducted this trial to assess the efficacy of insulin lispro treatment in Chinese patients The short-acting insulin analogue lispro ( [ LYS(B28 ) , PRO(B29 ) ] is absorbed from the subcutis more rapidly than soluble insulin ( S ) . To compare the clinical effectiveness of lispro vs S , 11 Type 1 patients using continuous subcutaneous insulin infusion ( CSII ) therapy ( 6 F , 5 M , age 30 + /- 2.5 years , diabetes duration 14 + /- 1.0 years , BMI 24.0 + /- 0.8 kg m(-2 ) , HbA1c 6.5 + /- 0.2 % ) were studied in an open , r and omized , crossover study for 6 months ( 3 months lispro and 3 months S or vice versa ) . During lispro treatment mean fasting and 2 h postpr and ial blood glucose were lower compared to the S phase ( fasting 6.5 + /- 0.4 vs 7.5 + /- 0.4 mmol l(-1 ) ( NS ) , postpr and ial 6.8 + /- 0.3 vs 8.3 + /- 0.3 mmol l(-1 ) , p = 0.03 ) . In patients treated first with lispro HbA1c levels improved from 6.3 + /- 0.2 % to 5.7 + /- 0.3 % ; On reversion to S HbA1c increased to 6.2 + /- 0.2 % . In the group treated first with S , HbA1c fell ( 6.7 + /- 0.4 % vs 6.5 + /- 0.3 % ) and then improved further to 6.3 + /- 0.3 % with lispro . None of these changes were significant . There was no significant difference with respect to hypoglycaemic or other adverse events . It can be concluded that lispro in CSII therapy is safe and may improve postpr and ial glucose excursions BACKGROUND Although insulin lispro ( insulin LP ) has been shown to improve postpr and ial blood glucose ( BG ) control and reduce hypoglycemic episodes in adult patients with type I diabetes , there appear to have been few clinical studies focusing on its use in adolescents . OBJECTIVE This study compared the effects of insulin LP with those of regular human insulin ( insulin R ) on postpr and ial BG control and hypoglycemia in adolescents with type diabetes . METHODS In this crossover , open-label study , adolescents between the ages of 9 and 18 years who had reached Tanner stage II puberty were r and omized to receive either insulin LP immediately before meals or insulin R 30 to 45 minutes before meals , in addition to daily intermediate-acting insulin . After 4 months , patients were switched to the alternate treatment sequence . Eight-point BG profiles , hypoglycemia rate , and glycosylated hemoglobin ( HbA1c ) were measured at baseline and end point . RESULTS Four hundred eighty-one adolescents participated in the study at 53 investigative sites in 15 countries ; 463 were r and omized to treatment ( 228 insulin LP , 235 insulin R ) , and 457 completed the study . Insulin LP given before breakfast result ed in significantly lower mean ( + /-SD ) 2-hour postpr and ial BG levels compared with insulin R ( 9.7 + /- 4.0 mmol/L vs 10.6 + /- 4.3 mmol/L , respectively ; P < 0.001 ) . Insulin LP given before dinner result ed in significantly lower 2-hour postpr and ial BG levels compared with insulin R ( 8.6 + /- 3.5 mmol/L vs 9.3 + /- 3.7 mmol/L ; P = 0.003 ) . No differences were seen between treatments in 2-hour postpr and ial BG levels after the midday meal . Mean baseline HbA1c values were similar between sequence groups , and no between-group difference in HbA1c was observed at end point ( insulin LP , 8.69 % + /- 1.52 % ; insulin R , 8.70 % + /- 1.65 % ) . Treatment with insulin LP result ed in a significantly lower incidence of hypoglycemic episodes per patient per 30 days compared with insulin R ( 4.02 + /- 4.5 vs 4.37 + /- 4.5 , respectively ; P = 0.023 ) and significantly fewer hypoglycemic episodes between midnight and 6 AM ( 1.0 + /- 1.9 vs 1.7 + /- 2.6 ; P < 0.001 ) . CONCLUSIONS In adolescents with type 1 diabetes , insulin LP significantly improved postpr and ial glycemic control and reduced episodes of nocturnal hypoglycemia compared with insulin R. Insulin LP was well tolerated and effective as part of an intensified insulin regimen in this study population OBJECTIVE The purpose of this study was to compare the pharmacokinetics and pharmacodynamics of the premixed insulin analogue biphasic insulin aspart ( BIAsp 30 ) with the equivalent premixed biphasic human insulin ( BHI 30 ) , administered twice daily , in patients with type 2 diabetes mellitus . METHODS In this r and omized , double-blind , crossover trial , 13 patients ( mean age , 64 years ; baseline mean glycosylated hemoglobin , 7.7 % ; mean body mass index , 28.1 kg/m2 ) received 2 weeks of treatment with BIAsp 30 and 2 weeks of BHI 30 administered immediately before dinner and breakfast . At the end of each 2-week treatment period , 24-hour serum insulin and glucose profiles were determined using specific 2-sided enzyme-linked immunosorbent assays . All pharmacodynamic and pharmacokinetic end points were analyzed using analysis of variance . RESULTS Total daily insulin exposure was similar between treatment periods . Mean area under the total insulin concentration-time profile during the 2 hours following administration of BIAsp 30 was 17 % greater than that of BHI 30 after dinner and 44 % greater after breakfast ; both differences were statistically significant . The maximum serum insulin aspart concentrations following BIAsp 30 were significantly higher after dinner ( 18 % ) and breakfast ( 35 % ) . Peak serum insulin concentration was reached 1 hour earlier after breakfast and 45 minutes earlier after dinner in the BIAsp 30 group ; differences were significant only after breakfast . The mean daily pr and ial glucose excursion was significantly lower for BIAsp 30 ( 16.2 mmol x h x L(-1 ) ) than BHI 30 ( 17.9 mmol x h x L(-1 ) ) . Postpr and ial 4-hour glucose excursions were significantly lower with BIAsp 30 than with BHI 30 after dinner and breakfast , but were significantly greater after lunch . Mean 24-hour and nocturnal serum glucose concentrations were similar , and both insulins were associated with < or = 7 minor and no major hypoglycemic events . CONCLUSIONS Premeal injection of BIAsp 30 in a twice-daily regimen significantly reduced overall postpr and ial glucose excursions . This effect may be of importance when improvement in postpr and ial glucose control is desired Lispro ( LP ) and regular human ( HR ) insulins were compared in Type 1 diabetic ( T1DM ) patients on either a Mediterranean diet or normal diet . Twelve T1DM patients were recruited and r and omized into two groups of 6 , groups A and B. They were treated in different sequences ( in 3-month intervals for 1 year ) . Group A : LP insulin and normal diet , LP insulin and Mediterranean diet , regular insulin and Mediterranean diet , regular insulin and normal diet . Group B : regular insulin and normal diet , regular insulin and Mediterranean diet , LP insulin and Mediterranean diet , LP insulin and normal diet . Each patient was treated with rapid acting insulin , either LP insulin or HR insulin , before each main meal and a dose of slow acting insulin at bedtime . Every 15 days the glycemic control , the incidence and frequency of hypoglycemic episodes , and any adverse events were evaluated . Every 3 months , h
Output:
| REVIEW ERS ' CONCLUSIONS Our analysis suggests only a minor benefit of short acting insulin analogues in the majority of diabetic patients treated with insulin . |
MS213449 | ***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 We analysed the difference in maternal , neonatal and total costs after single ( SET ) versus double day 3 embryo transfer ( DET ) . METHODS We performed a two-centre prospect i ve study of women in their first IVF/ICSI cycle choosing between SET or DET . Infertility treatment data were gathered from a data base ; maternal and neonatal outcome data from a case report form ( CRF ) ; health economic data from medical acts registered in the CRF for the outpatient part and from hospital bills . SET was performed in 206/367 ( 56.1 % ) and DET in 161/367 ( 43.9 % ) women . RESULTS In all , 367 transfers yielded 186 positive pregnancy tests , 148 ongoing pregnancies and 136 live deliveries ( 50.7 , 40.3 and 37.1 % per embryo transfer ) of which 15 ( 11.0 % ) were twins . Live birth rate was 37.4 % for SET , 36.6 % for DET . Intention-to-treat analysis showed differences for : duration of pregnancy ( SET : 39.0 + /- 1.4 versus DET : 38.3 + /- 2.2 weeks ; P = 0.055 ) , percentage prematurity ( 8.5 versus 23.8 % ; P = 0.033 ) , percentage of neonates hospitalized ( 5.7 versus 17.9 % ; P = 0.121 ) and duration of neonatal hospitalization ( 6.3 + /- 2.2 versus 10.3 + /- 10.1 days ; P = 0.01 ) . Total cost after DET was higher ( SET : 4700 + /- 3239 versus DET : 8613 + /- 10 105 ; P = 0.105 ) , due to significantly higher neonatal costs ( 451 + /- 957 versus 3453 + /- 8154 ; P < 0.001 ) and not to differences in maternal costs ( 4250 + /- 2882 versus 5160 + /- 4106 ; P = 0.152 ) . CONCLUSIONS This prospect i ve health economic study shows that transfer of a single top quality embryo is equally effective as , but substantially cheaper than , double embryo transfer in women < 38 years of age in their first IVF/ICSI cycle BACKGROUND Transfer of several embryos after IVF results in a high multiple birth rate associated with increased morbidity and high costs for the neonatal care . In a previous r and omized trial we demonstrated that a single embryo transfer ( SET ) strategy , including one fresh single embryo transfer and , if no live birth , one additional frozen-thawed SET , result ed in a live-birth rate that was not substantially lower than after double embryo transfer ( DET ) but markedly reduced the multiple birth rate . METHODS We compared costs for maternal health care and productivity losses and paediatric costs for the SET and DET strategies . In addition , maternal and paediatric outcomes between the two groups were compared . RESULTS The SET strategy result ed in lower average total costs from treatment until 6 months after delivery . There were a few more deliveries with at least one live-born child in the DET group . The incremental cost per extra delivery in the DET alternative was high , 71 940 . The rates of prematurely born and low birthweight children were significantly lower with the SET strategy . There were also markedly fewer maternal and paediatric complications in the SET group . CONCLUSIONS The SET strategy is superior to the DET strategy , when number of deliveries with at least one live-born child , incremental cost-effectiveness ratio and maternal and paediatric complications are taken into consideration . The findings do not support continuing transfers of two embryos in this group of patients Background The ' Hawthorne Effect ' may be an important factor affecting the generalisability of clinical research to routine practice , but has been little studied . Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge , no attempt has been made to quantify them . Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia . Methods Participants in a dementia trial were r and omised to intensive follow-up ( with comprehensive assessment visits at baseline and two , four and six months post r and omisation ) or minimal follow-up ( with an abbreviated assessment at baseline and a full assessment at six months ) . Our primary outcomes were cognitive functioning ( ADAS-Cog ) and participant and carer-rated quality of life ( QOL-AD ) . Results We recruited 176 participants , mainly through general practice s. The main analysis was based on Intention to treat ( ITT ) , with available data . In the ANCOVA model with baseline score as a co-variate , follow-up group had a significant effect on outcome at six months on the ADAS-Cog score ( n = 140 ; mean difference = -2.018 ; 95%CI -3.914 , -0.121 ; p = 0.037 favouring the intensive follow-up group ) , and on participant-rated quality of life score ( n = 142 ; mean difference = -1.382 ; 95%CI -2.642 , -0.122 ; p = 0.032 favouring minimal follow-up group ) . There was no significant difference on carer quality of life . Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia result ed in a better outcome than minimal follow-up , as measured by their cognitive functioning . Trial registration Current controlled trials : IS RCT BACKGROUND Elective single embryo transfer ( eSET ) in a selected group of patients ( i.e. young patients with at least one good quality embryo ) reduces the number of multiple pregnancies in an IVF programme . However , the reduced overall multiple pregnancy rate ( PR ) is still unacceptably high . Therefore , a r and omized controlled trial ( RCT ) was conducted comparing eSET and double embryo transfer ( DET ) in an unselected group of patients ( i.e. irrespective of the woman 's age or embryo quality ) . METHODS Consenting unselected patients were r and omized between eSET ( RCT -eSET ) ( n = 154 ) or DET ( RCT -DET ) ( n = 154 ) . R and omization was performed just prior to the first embryo transfer , provided that at least two 2PN zygotes were available . Non- participants received our st and ard transfer policy [ SP-eSET in a selected group of patients ( n = 100 ) , otherwise SP-DET ( n = 122 ) ] . RESULTS The ongoing PR after RCT -eSET was significantly lower as compared with RCT -DET ( 21.4 versus 40.3 % ) and the twin PR was reduced from 21.0 % after RCT -DET to 0 % after RCT -eSET . The ongoing PRs after SP-eSET and SP-DET did not differ significantly ( 33.0 versus 30.3 % ) , with an overall twin PR of 12.9 % . CONCLUSION To avoid twin pregnancies result ing from an IVF treatment , eSET should be applied in all patients . The consequence would be a halving of the ongoing PR as compared with applying a DET policy in all patients . The transfer of one embryo in a selected group of good prognosis patients leads to a less drastic reduction in PR but maintains a twin PR of 12.9 % BACKGROUND The main reason for adverse treatment outcome in assisted reproduction is the high rate of multiple pregnancies . The only strategy to avoid dizygotic twins is to transfer one embryo at a time . METHODS A total of 144 women , who had had at least four good quality embryos available after IVF/intracytoplasmic sperm injection ( ICSI ) and who had no more than one previous failed treatment cycle , were r and omized to have either one or two embryos transferred . The treatment outcomes including those after frozen embryo transfer were compared between these groups . RESULTS The clinical pregnancy rate per transfer was 32.4 % in the one embryo transfer group and 47.1 % in the two embryo transfer group , the difference being not significant . Eleven twin deliveries ( n = 39 ) occurred in the two embryo transfer group and there was one pair of monozygotic twins in the one embryo transfer group . The cumulative pregnancy rate per patient after transfer of fresh and frozen embryos was 47.3 % in the one embryo transfer group and 58.6 % in the two embryo transfer group . CONCLUSIONS Our results indicate that among women who have good quality embryos in their first IVF/ICSI , good treatment results can be achieved . They support the idea of changing embryo transfer policy towards one embryo transfer without any remarkable decrease in the success rate , while dizygotic twins can be avoided BACKGROUND With the aim of reducing the number of multiple pregnancies after IVF we investigated the effectiveness of two cycles with single embryo transfer ( SET ) and one cycle with double embryo transfer ( DET ) after IVF and calculated the cost-effectiveness of both strategies . METHODS A r and omized controlled trial was performed in 107 women , aged < 35 years , in their first IVF cycle , with at least one good quality embryo . They were r and omized to the SET ( n = 54 ) or DET ( n = 53 ) group using a computer-generated r and om block number table , stratified for primary or secondary infertility . RESULTS The cumulative live birth rates per woman r and omized of two consecutive cycles of SET [ 41 % ; 95 % confidence interval ( CI ) 27 - 54 ] versus one cycle of DET ( 36 % ; 95 % CI 23 - 49 ) were comparable , whereas the multiple pregnancy rate was significantly higher : 37 % ( 95 % CI 15 - 59 ) in the DET and 0 % in the in the SET group ( P = 0.002 ) . Combining the medical costs of the IVF treatments ( where 1.5 more SET cycles were required to achieve each live birth ) and of pregnancies up to 6 weeks after delivery , the total medical costs of DET per live birth were 13,680 and 13,438 for SET . CONCLUSIONS Two cycles with SET were equally effective as one cycle with DET , and the medical costs per live birth up to 6 weeks after delivery were the same . However , if lifetime costs for severe h and icaps are included , more than 7000 per live birth will be saved after implementing SET . Because of the high probability of multiple pregnancies in this group of IVF patients , only SET should be performed BACKGROUND The purpose of this study was to assess the effect of alternative ways of providing information about the risks of twins on couples ' perceptions about elective single embryo transfer ( eSET ) . METHODS Couples undergoing IVF were r and omized into three groups . Group 1 received a st and ard information pack , group 2 an extra information leaflet about twin pregnancy , and group 3 an additional discussion session . The primary outcome measure was acceptability of a hypothetical policy of eSET . Data were collected by means of a question naire . RESULTS eSET was acceptable to 17 ( 27 % ) , 20 ( 30 % ) and 24 ( 32 % ) couples in groups 1 , 2 and 3 , if it meant a slight reduction in pregnancy rates , and to 51 ( 82 % ) , 55 ( 83 % ) and 53 ( 87 % ) couples , respectively , if pregnancy rates were unchanged . A fixed charge for all fresh and frozen embryo transfers following a single oocyte retrieval led to acceptability rates of 35 ( 57 % ) , 36 ( 55 % ) and 38 ( 65 % ) . CONCLUSIONS Additional information , involving an extra information leaflet and face to face discussion , did not changes couples ' attitudes towards eSET . Maintaining existing rates of pregnancy and offering a fixed charge for all embryo transfers result ing from an oocyte recovery may encourage more couples to consider eSET OBJECTIVE To determine the extent to which embryo selection by blastulation and elective single blastocyst transfer , supported by efficient cryostorage of spare embryos , can reduce multiple pregnancies and maintain or improve on the live birth rate from IVF . DESIGN Prospect i ve , nonr and omized cohort study . SETTING Sydney IVF , a private clinic in Australia . PATIENT(S ) In vitro fertilization patients aged < 38 years with three or more usable blastocyst , recruited from April 2000 through December 2001 , with pregnancies followed up until August 2004 . INTERVENTION(S ) Blastocysts were cultured and cryostored with stage-specific culture medium and low oxygen conditions . MAIN OUTCOME MEASURE(S ) Fetal heart-positive twin pregnancy rate and accumulating " take-home baby " rate per retrieval leading to blastocyst transfer . RESULT ( S ) Among 121 women who elected single fresh blastocyst transfer ( but who could elect to have two frozen blastocysts transferred at once ) , 79 ( 65.3 % ) took home a baby , with a twin pregnancy rate of 7 % . Among 285 women who chose two blastocysts for fresh transfer , 184 ( 64.2 % ) took home at least one baby , with a twin pregnancy rate of 34 % and five perinatal deaths . CONCLUSION ( S ) With
Output:
| ( S ) Elective single embryo transfer is associated with decreased risks of PTB and LBW compared with DET but higher risks of PTB compared with spontaneously conceived singletons |
MS213450 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract Objective : To evaluate the 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 — Indirect evidence shows that alerting users with clinical decision support systems seems to change behavior more than requiring users to actively initiate the system . However , r and omized trials comparing these methods in a clinical setting are lacking . We studied the effect of both alerting and on-dem and decision support with respect to screening and treatment of dyslipidemia based on the guidelines of the Dutch College of General Practitioners . Methods and Results — In a clustered r and omized trial design , 38 Dutch general practice s ( 77 physicians ) and 87 886 of their patients ( 39 433 men 18 to 70 years of age and 48 453 women 18 to 75 years of age ) who used the ELIAS electronic health record participated . Each practice was assigned to receive alerts , on-dem and support , or no intervention . We measured the percentage of patients screened and treated after 12 months of follow-up . In the alerting group , 65 % of the patients requiring screening were screened ( relative risk versus control=1.76 ; 95 % confidence interval , 1.41 to 2.20 ) compared with 35 % of patients in the on-dem and group ( relative risk versus control=1.28 ; 95 % confidence interval , 0.98 to 1.68 ) and 25 % of patients in the control group . In the alerting group , 66 % of patients requiring treatment were treated ( relative risk versus control=1.40 ; 95 % confidence interval , 1.15 to 1.70 ) compared with 40 % of patients ( relative risk versus control=1.19 ; 95 % confidence interval , 0.94 to 1.50 ) in the on-dem and group and 36 % of patients in the control group . Conclusion — The alerting version of the clinical decision support systems significantly improved screening and treatment performance for dyslipidemia by general practitioners BACKGROUND Good blood pressure ( BP ) control reduces the risk of complications in people with type 2 diabetes , yet many do not achieve this . Guidelines for managing hypertension recommend increasing antihypertensive medications until control is achieved , but the effect of such recommendations in routine primary care is unknown . AIM To evaluate the effectiveness of a BP treatment algorithm in primary care patients with type 2 diabetes . DESIGN OF STUDY A cluster r and omised controlled trial of 1534 patients with type 2 diabetes . SETTING Forty-two practice s in Nottingham , UK . METHOD Practice s were r and omised to continue usual care or to use a treatment algorithm design ed so that practice nurses and GPs would increase antihypertensive treatment in steps until the target of 140/80 mmHg was reached . Participants were assessed by a clinical interview and case note review at recruitment and at 1 year . The primary outcome measure was the proportion of participants achieving target BP at 1 year . RESULTS At 1 year there was no difference between the proportions of participants with well controlled BP in the intervention and control arms ( 36.6 % versus 34.3 % ; P = 0.27 ) . Mean systolic and diastolic blood pressures were identical in the two arms ( 143/78 mmHg ) . There was some evidence that participants in the intervention arm were more likely to be receiving higher doses of their antihypertensive drugs , although there was no significant difference in the number of different antihypertensive drugs prescribed . Participants in the intervention arm had a higher rate of primary care BP-related consultations over 12 months than those receiving usual care ( rate ratio = 1.55 , 95 % confidence interval [ CI ] = 1.26 to 1.88 , P<0.001 ) . CONCLUSION Despite increased monitoring and possibly higher doses of medication there was no improvement in blood pressure control . Improvements achieved by specialist nurse-led clinics in secondary care may not translate to people with type 2 diabetes in primary care setting OBJECTIVE To measure the effect of faith community nurse referrals versus telephone-assisted physician appointments on blood pressure control among persons with elevated blood pressure at health fairs . METHODS R and omized community-based intervention trial conducted from October 2006 to October 2007 of 100 adults who had an average blood pressure reading equal to or above a systolic of 140 mm Hg or a diastolic of 90 mm Hg obtained at a faith community nurse-led church health event . Participants were r and omized to either referral to a faith community nurse or to a telephone-assisted physician appointment . The average enrollment systolic blood pressure ( SBP ) was 149 ± 14 mm Hg , diastolic blood pressure ( DBP ) was 87 ± 11 mm Hg , 57 % were uninsured and 25 % were undiagnosed at the time of enrollment . RESULTS The follow-up rate was 85 % at 4 months . Patients in the faith community nurse referral arm had a 7 ± 15 mm Hg drop in SBP versus a 14 ± 15 mm Hg drop in the telephone-assisted physician appointment arm ( p = 0.04 ) . Twenty-seven percent of the patients in the faith community nurse referral arm had medication intensification compared to 32 % in the telephone-assisted physician appointment arm ( p = 0.98 ) . CONCLUSIONS Church health fairs conducted in low-income , multiethnic communities can identify many people with elevated blood pressure . Facilitating physician appointments for people with elevated blood pressure identified at health fairs confers a greater decrease in SBP than referral to a faith community nurse at four months Address correspondence to : L.D. Saunders , Department of Health Services Administration and Community Medicine , 13 - 103 Clinical Sciences Building , University of Alberta , Edmonton , Alberta Canada T6 G 2G3 among patients attending a primary health care ( PHC ) clinic in Soweto for antihypertensive drug therapy . In a 1-year follow-up study of an inception cohort of newly treated hypertensives , only 27 % were compliant ( defined as attending frequently enough to receive 80 % or more of their required treatment ) , 42 % were not seen after the first 3 months ( early dropouts ) , and 22 % continued to attend until the last 3 PURPOSE Dyslipidemia treatment dramatically decreases coronary heart disease risk in diabetes , yet only a minority of these patients are screened or achieve optimal low-density lipoprotein ( LDL ) cholesterol levels . Our aim was to increase the percentage of diabetic patients in whom lipid management was achieved through electronic and direct educational detailing . METHODS The study cohort comprised 884 diabetic patients at 12 primary care practice s. Practice sites were r and omized to one of three intervention groups : electronic educational detailing , direct ( face-to-face ) educational detailing , or control . Direct and electronic detailing were performed over a 12-month period . All sites were notified of our goal to enhance lipid testing among diabetic patients . Chart abstract ion was performed 15 months after the start of the intervention . For the entire population ( n=884 ) , the proportion of patients with lipid testing was calculated , and changes from pre- to postintervention were compared across groups . We compared pre- and postintervention LDL-cholesterol changes between groups using least square means to account for site variation . RESULTS Favorable provider actions increased significantly with the intervention ( + 22 % compared with + 6 % in controls , P=.01 ) . By logistic regression , electronic detailing increased the likelihood of lipid testing ( odds ratio 3.0 , confidence interval 1.6 - 5.7 ) , as did direct detailing ( odds ratio 1.8 , confidence interval 0.9 - 3.7 ) in patients with no preintervention LDL test ( n=432 ) . Lipid testing tended to increase to a greater extent at intervention sites ( + 23 % for the combination of electronic and direct detailing vs + 11 % for controls , P=.06 ) . CONCLUSIONS Brief educational detailing either through direct or electronic communication favorably impacts provider behavior regarding dyslipidemia care for diabetic patients Background The heterogeneity statistic I2 , interpreted as the percentage of variability due to heterogeneity between studies rather than sampling error , depends on precision , that is , the size of the studies included . Methods Based on a real meta- analysis , we simulate artificially ' inflating ' the sample size under the r and om effects model . For a given inflation factor M = 1 , 2 , 3 , ... and for each trial i , we create a M-inflated trial by drawing a treatment effect estimate from the r and om effects model , using si2MathType@MTEF@5@5@+=feaagaart1ev2aaatCvAUfKttLearuWrP9MDH5MBPbIqV92AaeXatLxBI9gBaebbnrfifHhDYfgasaacPC6xNi = xH8viVGI8Gi = hEeeu0xXdbba9frFj0xb9qqpG0dXdb9aspeI8k8fiI+fsY = rqGqVepae9pg0db9vqaiVgFr0xfr = xfr = xc9adbaqaaeGaciGaaiaabeqaaeqabiWaaaGcbaGaem4Cam3aa0baaSqaaiabdMgaPbqaaiabikdaYaaaaaa@2FBE@/M as within-trial sampling variance . Results As precision increases , while estimates of the heterogeneity variance τ2 remain unchanged on average , estimates of I2 increase rapidly to nearly 100 % . A similar phenomenon is apparent in a sample of 157 meta-analyses . Conclusion When deciding whether or not to pool treatment estimates in a meta- analysis , the yard-stick should be the clinical relevance of any heterogeneity present . τ2 , rather than I2 , is the appropriate measure for this purpose BACKGROUND Although high blood pressure is associated with significant morbidity and mortality , the proportion reaching the goal blood pressures as outlined in the Seventh Report of the Joint National Committee on Prevention , Detection , Evaluation , Treatment of High Blood Pressure ( JNC 7 ) is low . We conducted a r and omized trial in primary care practice s of a multifactorial intervention targeted to improve providers ' adherence to hypertension guidelines . METHOD A total of 61 primary care practice s in North Carolina were r and omized to receive either a multifactorial intervention ( guideline dissemination via a continuing medical education session , academic detailing sessions , audit and feedback on preintervention rates of adherence , and automated blood pressure machines ) or an attention control of similar magnitude but targeted at a different guideline . Outcomes were determined through review of patient charts conducted by an independent masked quality assurance organization . RESULTS We found no difference between the 2 groups in any of the adherence measures including no difference in the percentage of patients at goal ( intervention 49.2 % , control 50.6 % ) , with undiagnosed hypertension ( 18.1 % vs 13.6 % ) , average systolic ( 126 vs 125.1 mm Hg ) , or diastolic blood pressure ( 73.1 vs 73.4 mm Hg ) . Similarly , there was no difference in provider adherence to treatment recommendations ( use of thiazide-type diuretic as first-line therapy : 32 % vs 29.5 % ; use of 2-drug therapy in stage 2 hypertension : 11.3 % vs 10.4 % ) . CONCLUSION An intensive , multifactorial intervention did not improve adherence to national hypertension guidelines among community-based primary care . Efforts should be focused on other types of interventions to improve rates of control of hypertension Introduction We aim ed to assess whether hypertension management with a structured physician information program and a feedback system leads to improved blood pressure ( BP ) control and cardiovascular outcomes . Methods Cluster r and omized ( 3 : 1 ) , open , monitored , multicenter trial in Germany . Primary care-based physicians in the information group ( IG ) received detailed training on hypertension guidelines , feedback on target-level attainment , and a reminder to intensify treatment after each patient visit , whereas the observation/control group ( CG ) did not receive any such measures . A three-level mixed model was developed . Time-independent level differences between groups , group-independent changes , and nonparallel group-specific changes over time were tested . Results A total of 15 041 ( 78.1 % ) hypertensive patients were in the IG and 4213 ( 21.9 % ) in the CG . By 1-year follow-up , 82.9 % of patients in
Output:
| Implementation strategies were shown to be effective with substantial heterogeneity of treatment effects across all investigated strategies .
Especially the cooperation of different health professionals in primary care practice s might increase efficacy and guideline implementation seems to be more difficult in tertiary prevention of cardiovascular diseases |
MS213451 | ***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: Acutely psychotic patients presenting as psychiatric emergencies with aggression or agitation are often administered conventional antipsychotics intramuscularly . However , patients view intramuscular administration as coercive , and conventional antipsychotics are often associated with adverse events . In this open study , consecutive adult patients presenting with an acute exacerbation of schizophrenia or other psychotic disorder were assigned to oral risperidone 2 - 6 mg/day ( n = 48 ) or oral zuclopenthixol 20 - 50 mg/day ( n = 27 ) for 7 - 14 days . Lorazepam ( either oral or intramuscular ) was administered to both groups as needed . Patients were assessed regularly until day 14 or discharge . Mean Positive And Negative Syndrome Scale ( PANSS ) aggression scores ( sum of item scores on excitement , poor impulse control , hostility and uncooperativeness ) decreased steadily and similarly in both groups ; the mean changes from baseline were statistically significant at days 10 and 14 and at study end-point . The mean decrease at study end-point in the PANSS component score for hostility was statistically significant in the risperidone group , but not in the zuclopenthixol group . Social Dysfunction and Aggression Scale aggression scores and Clinical Global Impression scores decreased significantly and similarly in both groups . Overall , 18.7 % of patients showed minor extrapyramidal symptoms during the study , but only 16.7 % of risperidone-treated patients , compared to 59.3 % of zuclopenthixol-treated patients , received anti-parkinsonian medication ( p < 0.001 ) . Lorazepam was administered to all of the patients assigned to risperidone and to 89 % of those assigned to zuclopenthixol . Oral risperidone plus lorazepam is a convenient , effective and well-tolerated alternative to conventional antipsychotics for the treatment of acute psychosis in emergency psychiatry 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 Abstract Intramuscular ( IM ) antipsychotics are preferred for efficient control of agitation symptoms . Previous studies have demonstrated that IM ziprasidone is efficacious and safe for treatment of agitation in schizophrenia . However , clinicians now recognize that racial differences may contribute to altered therapeutic response and tolerability . This study compared the efficacy and tolerability of IM ziprasidone versus IM haloperidol for the management of agitation in Chinese subjects with schizophrenia . Subjects with acute schizophrenia were r and omized to either ziprasidone ( n = 189 , 10 to 20 mg as required up to a maximum of 40 mg/d ) or haloperidol ( n = 187 , 5 mg every 4 to 8 hours to a maximum of 20 mg/d ) for 3 days . Psychiatric assessment s and adverse events were assessed at baseline , 2 , 4 , 24 , 48 , and 72 hours . In the ziprasidone group , 2.1 % of subjects discontinued versus 3.7 % in the haloperidol group . The least squares mean change ( SE ) from baseline to 72 hours in Brief Psychiatry Rating Scale total score was −17.32 ( 0.7 ) for ziprasidone ( n = 167 ) and −18.44 ( 0.7 ) for haloperidol ( n = 152 ) , with a 95 % confidence interval treatment difference of −0.7 to 2.9 . Fewer subjects experienced adverse events after ziprasidone ( n = 54 , 28.6 % ) than haloperidol ( n = 116 , 62.0 % ) , with a notably higher incidence of extrapyramidal symptoms in the haloperidol group ( n = 69 , 36.9 % ) compared to the ziprasidone group ( n = 4 , 2.1 % ) . For controlling agitation in schizophrenia in this Chinese study , ziprasidone had a favorable tolerability profile and comparable efficacy and safety compared to haloperidol OBJECTIVE The objective of this study was to compare the efficacy and side effects of sodium cromoglycate eye drops ( Opticrom 2 % ) used regularly versus as needed in the treatment of seasonal ( ragweed ) allergic conjunctivitis . METHODS A r and omized , unblinded , parallel group comparison was performed during the 6 weeks of the ragweed pollen season . Sixty-two adults with ragweed pollen-induced conjunctivitis were recruited for the study from previous ragweed studies and notices in the local media . Two drops of sodium cromoglycate were placed in each eye either four times daily ( regular treatment group ) or when needed , up to four times daily ( prn group ) , from 1 week before and throughout the ragweed pollen season . Uncontrolled eye symptoms were treated with terfenadine 60 mg as needed , up to 120 mg daily . Subjects kept daily diaries for symptoms and medication requirements throughout the 6 weeks of treatment . The Rhinoconjunctivitis Quality of Life Question naire was administered and adverse experiences were reported after 1 , 3 , and 6 weeks of treatment . RESULTS Diary eye symptoms were similar in the two treatment groups , but quality of life was better in the regular treatment group . There was a trend for the prn group to require more terfenadine for uncontrolled eye symptoms . CONCLUSIONS There may be some additional therapeutic benefit from using sodium cromoglycate eye drops regularly throughout the ragweed pollen season OBJECTIVE This study compared the effects of atypical antipsychotics ( risperidone or quetiapine ) with placebo and with each other in recently exacerbated patients with schizophrenia requiring hospitalization . METHODS This international , r and omized , double-blind study included a 2-week monotherapy phase followed by a 4-week additive therapy phase . Recently exacerbated patients with schizophrenia or schizoaffective disorder ( DSM-IV ) were r and omized ( 2:2:1 ) to risperidone ( n = 153 ) , quetiapine ( n = 156 ) , or placebo ( n = 73 ) . Target doses were 4 or 6 mg/day of risperidone and 400 or 600 mg/day of quetiapine by day 5 , with the ability to increase to 600 or 800 mg/day of quetiapine on day 8 . The main outcome measures were the total Positive and Negative Syndrome Scale ( PANSS ) and need for additional psychotropic medications . RESULTS Monotherapy Phase : The combined atypical antipsychotic group ( n = 308 ) reached borderline superiority to placebo ( n = 71 ) at the 2-week endpoint on mean change in total PANSS score ( -24.1 + /- 1.2 and -20.2 + /- 2.0 , respectively ; p = 0.067 ) . The change in the atypical group was driven by the improvement with risperidone ( -27.7 + /- 1.5 vs. -20.2 + /- 2.0 with placebo , p < 0.01 ; and vs. -20.5 + /- 1.5 with quetiapine , p < 0.01 ) ; the improvement with quetiapine was similar to placebo , p = 0.879 . Results were similar on other efficacy endpoints . Additive Therapy Phase : Additional psychotropics were prescribed to fewer ( p < 0.01 ) risperidone ( 36 % ) than quetiapine ( 53 % ) or placebo patients ( 59 % ) . The overall discontinuation rate was 18 % , 26 % , and 38 % , respectively . Risperidone , compared with placebo , was associated with more parkinsonism , akathisia , plasma prolactin changes , and weight gain ; while quetiapine was associated with more somnolence , sedation , dizziness , constipation , tachycardia , thyroid dysregulation , and weight gain . CONCLUSION While the combined atypical antipsychotic group did not experience greater improvements than the placebo group , risperidone , but not quetiapine , was significantly superior in all measured domains to placebo in the management of recently exacerbated hospitalized patients with schizophrenia or schizoaffective disorder , with no unexpected tolerability findings We conducted a prospect i ve double-blind study of accelerated dose titration of olanzapine in the treatment of newly admitted acutely agitated patients with schizophrenia . Patients were r and omized to either oral olanzapine ( 10 mg per day ) or oral haloperidol ( 10 mg per day ) , plus lorazepam as needed ( up to 12 mg per day ) . Antipsychotic dosage was increased to 20 mg per day as early as day 3 . Patients were evaluated with the Positive and Negative Syndrome Scale ( PANSS ) Agitation subscale during the first 24 hours of treatment , daily for the first week , then weekly until study completion . Significant within-group improvement was demonstrated in PANSS Agitation scores for both groups as early as 1 hour after initiating therapy ( -5.79 + /- 6.30 for olanzapine and -4.89 + /- 6.05 for haloperidol , P < .001 ) . This study demonstrated that accelerated dose titration of oral olanzapine is as efficacious as oral haloperidol in reducing acute agitation in patients with schizophrenia Background Patients experiencing an acute decompensation of schizophrenia or bipolar disorder often present in an agitated state . Agitation presents a barrier to therapy , interrupting the typical physician-patient alliance and creating a disruptive , even hazardous , environment . Rapid assessment and effective treatment are necessary to manage agitation and , potentially , to shorten the time to recovery . Methods One hundred forty-eight acutely agitated patients received either : rapid initial dose escalation ( RIDE ) in which up to 40 mg of oral olanzapine was allowed on days 1 and 2 , up to 30 mg on days 3 and 4 , and 5 to 20 mg thereafter ; or usual clinical practice ( UCP ) in which patients received 10 mg/d olanzapine plus up to 4 mg lorazepam on days 1 and 2 , up to 2 mg on days 3 and 4 , and olanzapine 5 to 20 mg/d thereafter . The Positive and Negative Syndrome Scale-Excited Component ( PANSS-EC : poor impulse control , tension , hostility , uncooperativeness , and excitement ) measured at 24 hours was the primary measure . Secondary assessment s of agitation and safety were also performed . Results Agitation improved significantly from baseline for both treatment groups ; however , improvement with the RIDE strategy was superior to UCP . The RIDE group improvement was superior on the primary efficacy measure ( PANSS-Excited ) at 24 hours ; it was superior on all agitation measures at the end of double-blind treatment . Both treatments were well tolerated , with no clinical ly significant differences in safety measures . Treatment was not limited by oversedation and attention improved from baseline in both groups . Conclusions This study demonstrates the value of olanzapine in the treatment of acutely agitated patients . A new approach to olanzapine dosing that exp and s the initial dose range up to 40 mg/d may offer superior efficacy in rapidly and effectively controlling the symptoms of agitation BACKGROUND There is a clear need for effective , well-tolerated intramuscular ( i.m . ) agents for the acute control of agitated psychotic patients . Currently used agents , including conventional antipsychotics and /or benzodiazepines , may be associated with distressing side effects such as extrapyramidal side effects and excessive sedation . OBJECTIVE The objective of this study was to evaluate the efficacy and tolerability of the rapid-acting i.m . formulation of the novel antipsychotic ziprasidone in the treatment of in patients with psychosis and acute agitation ( DSM-IV diagnoses ) . METHOD In a 24-hour , double-blind , fixed-dose clinical trial , patients were r and omly assigned to receive up to 4 injections ( every 2 hours p.r.n . ) of 2 mg ( N = 54 ) or 10 mg ( N = 63 ) of ziprasidone i.m . The Behavioral Activity Rating Scale measured behavior
Output:
| Our main outcomes of interest were important changes in ( i ) mental state , ( ii ) behaviour , ( iii ) dose of medication used , ( iv ) adverse events , ( v ) satisfaction with care and ( iv ) cost of care . |
MS213452 | ***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: IMPORTANCE Resveratrol , a polyphenol found in grapes , red wine , chocolate , and certain berries and roots , is considered to have antioxidant , anti-inflammatory , and anticancer effects in humans and is related to longevity in some lower organisms . OBJECTIVE To determine whether resveratrol levels achieved with diet are associated with inflammation , cancer , cardiovascular disease , and mortality in humans . DESIGN Prospect i ve cohort study , the Invecchiare in Chianti ( InCHIANTI ) Study ( " Aging in the Chianti Region " ) , 1998 to 2009 conducted in 2 villages in the Chianti area in a population -based sample of 783 community-dwelling men and women 65 years or older . EXPOSURES Twenty-four-hour urinary resveratrol metabolites . MAIN OUTCOMES AND MEASURES Primary outcome measure was all-cause mortality . Secondary outcomes were markers of inflammation ( serum C-reactive protein [ CRP ] , interleukin [IL]-6 , IL-1β , and tumor necrosis factor [ TNF ] ) and prevalent and incident cancer and cardiovascular disease . RESULTS Mean ( 95 % CI ) log total urinary resveratrol metabolite concentrations were 7.08 ( 6.69 - 7.48 ) nmol/g of creatinine . During 9 years of follow-up , 268 ( 34.3 % ) of the participants died . From the lowest to the highest quartile of baseline total urinary resveratrol metabolites , the proportion of participants who died from all causes was 34.4 % , 31.6 % , 33.5 % , and 37.4 % , respectively ( P = .67 ) . Participants in the lowest quartile had a hazards ratio for mortality of 0.80 ( 95 % CI , 0.54 - 1.17 ) compared with those in the highest quartile of total urinary resveratrol in a multivariable Cox proportional hazards model that adjusted for potential confounders . Resveratrol levels were not significantly associated with serum CRP , IL-6 , IL-1β , TNF , prevalent or incident cardiovascular disease , or cancer . CONCLUSIONS AND RELEVANCE In older community-dwelling adults , total urinary resveratrol metabolite concentration was not associated with inflammatory markers , cardiovascular disease , or cancer or predictive of all-cause mortality . Resveratrol levels achieved with a Western diet did not have a substantial influence on health status and mortality risk of the population in this study BACKGROUND & AIMS Blond orange juice is the most consumed fruit juice in the world . It is a source of hesperidin , a bioavailable flavonoid reported to exhibit potential vascular protective actions . However , the specific impact on vascular function of Citrus phytomicronutrients , is unknown . For the first time , we investigated the effects of blond orange juice compared with a control beverage mimicking the composition of orange juice ( including Vitamin C but no phytomicronutrients ) , on antioxidant markers , cardiovascular risk factors and endothelial function . METHODS Twenty five male volunteers with two cardiovascular risk factors ( age over 50 years and LDL-cholesterol between 130 and 190 mg/L ) were enrolled in a r and omized cross-over study . They received 3 times daily 200 mL of either blond orange juice or control beverage for 4 weeks , spaced by a 5-week wash-out . Endothelial function ( flow mediated dilatation and plasma markers ) , oxidative status , lipid profile and inflammatory markers were assessed . RESULTS Daily intakes of orange juice significantly led to a marked antioxidant effect which was correlated to hesperetin plasma levels and related with a decrease in reactive oxygen species . A tendency towards reduction of endothelial dysfunction and modest increase in plasma apoA-I concentration were also observed . This allows further experiments demonstrating the specific effect of phytomicronutrients from orange juice . CONCLUSIONS These findings suggest that daily intake of nutritionally relevant dose of blond orange juice may contribute for a significant antioxidant effect through the phytochemicals contained in . Orange juice may be associated to other healthy foods to achieve a significant effect on the vascular function . This study is recorded in Clinical Trials.com as NCT00539916 BACKGROUND Oxidative and inflammatory stresses are involved in the pathogenesis of atherosclerosis . The consumption of fruit and vegetables is associated with improved health and reduced cardiovascular risk . Red oranges have a high content of antioxidant and antiinflammatory substances , but there is a paucity of data concerning their effects on cardiovascular biomarkers in subjects with increased cardiovascular risk . OBJECTIVE We investigated the effect of red orange juice intake on endothelial function , oxidative stress , and markers of inflammation in subjects with increased cardiovascular risk . DESIGN Nineteen nondiabetic subjects with increased cardiovascular risk ( aged 27 - 56 y ) were included in a r and omized , placebo-controlled , single-blind crossover study and compared with 12 healthy , nonobese control subjects . In 2 periods of 7 d each with a 3-d interval , each participant alternatively received 500 mL red orange juice/d and 500 mL placebo/d in a r and om sequence . All measurements were performed in the morning after overnight fasting . RESULTS Endothelial function , which was measured as flow-mediated dilation , significantly improved and was normalized ( 5.7 % compared with 7.9 % ; P < 0.005 ) after 1 wk of red orange juice consumption . Similarly , concentrations of high-sensitivity C-reactive protein , IL-6 , and TNF-α significantly decreased ( P < 0.001 ) . Red orange juice had no significant effect on nitric oxide plasma concentrations . CONCLUSION A 7-d consumption of red orange juice ameliorates endothelial function and reduces inflammation in nondiabetic subjects with increased cardiovascular risk . This trial was registered at biomed central .com as IS RCT N39987296 The authors prospect ively evaluated fruit and vegetable consumption and the incidence of oral premalignant lesions among 42,311 US men in the Health Professionals Follow-up Study . Diet was assessed every 4 years by food frequency question naires . The authors confirmed 207 cases of clinical ly or histopathologically diagnosed oral premalignant lesions occurring between 1986 and 2002 . Multivariate-adjusted relative risks were calculated from proportional hazards models . Significant inverse associations were observed with citrus fruits , citrus fruit juice , and vitamin-C-rich fruits and vegetables , indicating 30 - 40 % lower risks with greater intakes ( e.g. , citrus fruit juice quintile 5 vs. quintile 1 relative risk = 0.65 , 95 % confidence interval : 0.42 , 0.99 ) . Inverse associations with fruits did not vary by smoking status and were stronger in analyses of baseline consumption , with a 10-year lag time to disease follow-up ( quintile 5 vs. quintile 1 relative risk = 0.41 , 95 % confidence interval : 0.20 , 0.82 ; p = 0.01 ) . No associations were observed with total vegetables or with beta-carotene-rich or lycopene-rich fruits and vegetables . For current smokers , green leafy vegetables ( ptrend = 0.05 ) and beta-carotene-rich fruits and vegetables ( ptrend = 0.02 ) showed significant linear trends of increased risk ( one additional serving/day relative risk = 1.7 ) . The risk of oral premalignant lesions was significantly reduced with higher consumption of fruits , particularly citrus fruits and juices , while no consistent associations were apparent for vegetables
Output:
| Conclusion : The studies discussed in this review strongly corroborate the role of Citrus juices and their derivatives as potential re source against cancer |
MS213453 | ***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: Clinical effectiveness of the double-blind administration of 1 and 2 % lidocaine solutions was evaluated for restorative and surgical procedures on primary molars of children 4.5 to 10.5 years old . This effectiveness was measured by changes in the child 's heart rate , the child 's self report of pain , and the operator 's assessment of the anesthesia 's effectiveness . Although the incidence of anesthetic failure was higher for the 1 % solution ( 31.3 % ) than for the 2 % solution ( 11.1 % ) , no statistically significant difference between the solutions was found . During the performance of pulpotomies and extraction s , a higher failure rate was recorded for the 1 % solution ( 62.5 % ) than for the 2 % solution ( 28.6 % ) , but these differences were not statistically significant . For minor restorative procedures , the 1 % solution was equally successful in achieving anesthesia . The results suggested that 1 % lidocaine should be used when multiple minor procedures are performed and potential toxicity in the young dental patient is a concern 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 OBJECTIVES The purpose of the study was to compare children 's reactions to inferior alveolar nerve injection with traditional syringe and periodontal ligament injection with a computerized device ( W and ) ; and to assess the efficacy of the anesthesia and their reaction after treatment . METHOD AND MATERIAL S Twenty-five children , aged 6 to 10 years , participated in the study . The contralateral primary m and ibular second molars were treated in 2 separate visits with r and om use of either the W and or traditional syringe injection . The pain perception levels for each step were assessed with El and Color Scale during the preparation . A Mann-Whitney U test was performed to compare the results . The patients were asked their preference of technique after the treatment . RESULTS When pain was measured immediately after injection , the traditional syringe was found to be more painful than injections with the W and ( P < .05 ) . Pain scores with the W and injections were found to be significantly ( P < .05 ) higher than those with traditional inferior alveolar nerve injections at the end of the restoration . The overwhelming majority of patients favored the periodontal ligament injection with the W and . CONCLUSION The W and technique provided significantly lower pain scores during the periodontal ligament injection . However , the pain scores during the treatment were significantly higher compared with the inferior alveolar nerve injections . Most of the patients stated that they preferred the periodontal ligament injection with the W and to the traditional inferior alveolar nerve injection PURPOSE Three identical single-dose , r and omized , double-blind , parallel-group , active-controlled multicenter studies were conducted to compare the safety and efficacy of articaine HCl ( 4 % with epinephrine 1:100,000 ) to that of lidocaine HCl ( 2 % with epinephrine 1:100,000 ) in patients aged 4 years to 79 years , with subgroup analysis on subjects 4 to < 13 years . METHODS Fifty subjects under the age of 13 years were treated in the articaine group and 20 subjects under the age of 13 were treated with lidocaine . Subjects were r and omized in a 2:1 ratio to receive articaine or lidocaine . Efficacy was determined on a gross scale immediately following the procedure by having both the subject and investigator rate the pain experienced by the subject during the procedure using a visual analog scale ( VAS ) . Safety was evaluated by measuring vital signs before and after administration of anesthetic ( 1 and 5 minutes post-medication and at the end of the procedure ) and by assessing adverse events throughout the study . Adverse events were elicited during telephone follow-up at 24 hours and 7 days after the procedure . RESULTS Pediatric patients received equal volumes , but higher mg/kg doses , of articaine than lidocaine during both simple and complex dental procedures . Pain ratings : Articaine : VAS ( Visual Analogue Scale ) scores ( from 0 to 10 cm ) by patients 4 to < 13 years of age were 0.5 for simple procedures and 1.1 for complex procedures , and average investigator scores were 0.4 and 0.6 for simple and complex procedures , respectively . Lidocaine : patients 0.7 ( simple ) and 2.3 ( complex ) ; investigators 0.3 ( simple ) and 2.8 ( complex ) . Adverse events : No serious adverse events related to the articaine occurred . The only adverse event considered related to articaine was accidental lip injury in one patient . CONCLUSIONS VAS scores indicate that articaine is an effective local anesthetic in children and that articaine is as effective as lidocaine when measured on this gross scale . Articaine 4 % with epinephrine 1:100,000 is a safe and effective local anesthetic for use in pediatric dentistry . Time to onset and duration of anesthesia are appropriate for clinical use and are comparable to those observed for other commercially available local anesthetics BACKGROUND Lidocaine is the gold st and ard anaesthetic solution that has been used since its inception into dentistry till date . Around 80 % of failures have been reported when lignocaine has been used for inferior alveolar nerve block in children and adults with irreversible pulpitis . There is a need to use newer drugs which are available which have been reported to be effective like lignocaine , such as articaine . Although articaine has been used in adults , literature supporting its use in children is sparse . AIM The purpose of this study is to compare the anaesthetic efficacy of 4 % articaine buccal infiltration and 2 % lignocaine inferior alveolar nerve block in children with irreversible pulpitis . It also aims to assess the need for supplemental intrapulpal injections . MATERIAL S AND METHODS This study was design ed as a r and omized double-blind cross over trial comparing the anaesthetic effectiveness of 4 % articaine with 1:100,000 epinephrine in buccal infiltration and 2 % lignocaine IAN block anaesthesia . The study subject and the pediatric dentist performing the pulpectomy procedures were blinded to the study . A sample size of 40 subjects in the age group of 5 - 8 y was included in the study . RESULTS The onset of anaesthesia with 4 % articaine was faster as compared to 2 % lignocaine . The duration of anaesthesia with articaine infiltration was shorter . The need for supplemental injection in the articaine group was less . CONCLUSION Four percent articaine infiltration can be used in children with irreversible pulpitis . It can be used to replace the IAN block in children thereby reducing the post anaesthetic complications like lip biting BACKGROUND The authors compared the safety and efficacy of 4 percent articaine with epinephrine 1:100,000 with 2 percent lidocaine with epinephrine 1:100,000 . METHODS In three identical r and omized , double-blind , multicenter trials , subjects 4 to 80 years of age received either 4 percent articaine with epinephrine 1:100,000 or 2 percent lidocaine with epinephrine 1:100,000 for simple or complex dental procedures . In each trial , the authors r and omized the subjects in a 2:1 ratio to receive articaine or lidocaine . Efficacy was determined by both subject and investigator using a visual analog scale , or VAS . The authors used the Kruskal-Wallis test to analyze the data . RESULTS A total of 882 subjects received articaine , and 443 received lidocaine . The authors found no statistical differences between the groups ( P = .05 ) . They also compared drug volumes for both articaine and lidocaine groups ( 2.5 milliliters + /- 0.07 st and ard error of mean , or SEM , vs. 2.6 mL + /- 0.09 SEM for simple procedures and 4.2 mL + /- 0.15 SEM vs. 4.5 mL + /- 0.21 SEM for complex procedures ) . The procedures ' duration s were comparable for both the articaine and lidocaine groups . The authors found no statistical difference between the two treatment groups ( P = .05 ) with respect to subject or investigator pain ratings using the VAS ; the mean pain scores determined by both patients and investigators for all groups tested were less than 1.0 . CONCLUSIONS The authors found that 4 percent articaine with epinephrine 1:100,000 was well-tolerated in 882 subjects . It also provided clinical ly effective pain relief during most dental procedures and had a time to onset and duration of anesthesia appropriate for clinical use and comparable to those observed for other commercially available local anesthetics . CLINICAL IMPLICATION S Pain control is a major component of patient comfort and safety . Local anesthetics form the backbone of pain control techniques in dentistry . Four percent articaine with epinephrine is an amide local anesthetic that will meet the clinical requirements for pain control of most dental procedures in most patients BACKGROUND Articaine administered through buccal infiltration ( BI ) has been suggested as providing adequate posterior m and ibular analgesia . This study compared the efficacy of articaine 4 % with 1:100 000 adrenaline ( test ) and lignocaine 2 % with 1:80 000 adrenaline ( control ) , delivered either through an inferior alveolar nerve block ( IANB ) or BI for routine restorative procedures in m and ibular posterior teeth among children . METHODS Children enrolled within the Western Australian School Dental Service and in need of restorative care on contralateral m and ibular posterior teeth were eligible . Consenting children were r and omly allocated to test and control techniques , and to type of local anaesthetic . Using the faces pain scale , pain reports from analgesia administration and from dental treatment were elicited . Analgesia success and pain reports were compared by anaesthetic technique and type . RESULTS Fifty-seven children were recruited into the study ; 29 allocated to IANB . Analgesia success for IANB 100 % ; BI 67 % ; p < 0.001 . Analgesia success for BI with articaine 71 % ; lignocaine 64 % , p > 0.05 . Analgesia success was associated with fewer reports of painful dental treatment , p = 0.005 . CONCLUSIONS There was higher success and less painful treatment with IANB . There was no statistically significant difference in local analgesia success between articaine and lignocaine when delivered via BI This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . " Quality " as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence PURPOSE The purpose of this study was to compare pain , efficacy and postoperative complications of anesthesia in first primary m and ibular molars anesthetized with either intraligamentary ( IL ) or supraperiosteal ( SP ) anesthesia using a computer-controlled delivery system ( CCDS ) . STUDY DESIGN This r and omized , controlled-crossover , blind clinical trial was conducted with 90 children requiring bilateral extraction , pulpotomy or restorative treatment of first m and ibular primary molars . A CCDS was used to deliver IL anesthesia to 1 deciduous tooth and SP anesthesia to the contralateral tooth in each patient . Severity of pain and efficacy of anesthesia during the treatments were evaluated using the Wong-Baker Faces Pain Rating Scale ( PRS ) and comfort and side effects were assessed using post-injection and post-treatment question naires . Data were analyzed using χ2 and Mann-Whitney U tests . RESULTS According to PRS scores , pain levels during extraction were significantly higher with IL when compared to SP . Patients reported significantly less pain during needle
Output:
| This reported inferior alveolar nerve block to be more effective than buccal infiltration for dental treatment of m and ibular molars , while no differences were found regarding pharmacological agents .
Conclusions At present , there is insufficient evidence in support of any pharmacologic agent or injection technique as being superior compared to others . |
MS213454 | ***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 The evaluation of a 13-month maintenance program ( MP ) for 39 severe COPD patients with FEV1%pred 44(7)% who , as result of two different 8-week leg exercise training ( LET ) programs , one supervised at the hospital ( group S ; n = 20 ) and the other self-monitored ( SM ; n = 19 ) , had achieved different levels of exercise tolerance . After LET , patients in group S had a higher maximal oxygen uptake and endurance time than patients in the SM group [ O2max 1.43(0.30 ) l · min−1 ] vs l.25(0.27 ) l · min−1 and endurance-time 16(4 ) min vs 12 ( 5 ) min , respectively ) . During the MP patients were advised to walk vigorously at least 4 km/day , 4 times/wk . After the MP , while endurance time remained higher than at baseline , it had decreased ( p < 0.01 ) immediately after LET in both groups and no differences were evident between groups ( 11(4 ) min and 10(4 ) , respectively ) . In contrast , Chronic Respiratory Diseases Question naire scores , which had improved significantly after LET in both groups , remained high . Long-term effects of MP were independent of the training strategy or whether physiological improvements had been obtained with the initial LET . SM exercise programs do not seem capable of maintaining physiological improvements in exercise tolerance , though “ quality of life ” can be maintained Limited information is available regarding the physiological responses to different types of exercise training in patients with severe chronic obstructive pulmonary disease ( COPD ) . The aim of this study was two fold : firstly , to investigate the physiological response to training at 60 % of achieved peak load in patients with severe COPD ; and secondly to study the effects of interval ( I ) versus continuous ( C ) training in these patients . Twenty-one patients with COPD ( mean+/-SD forced expiratory volume in one second : 37+/-15 % of predicted , normoxaemic at rest ) were evaluated at baseline and after 8 weeks ' training . Patients were r and omly allocated to either I or C training . The training was performed on a cycle ergometer , 5 days a week , 30 min daily . The total work load was the same for both training programmes . C training result ed in a significant increase in oxygen consumption ( V'O2 ) ( 17 % , p<0.05 ) and a decrease in minute ventilation (V'E)/V'O2 ( p<0.01 ) and V'E/carbon dioxide production ( V'CO2 ) ( p<0.05 ) at peak exercise capacity , while no changes in these measures were observed after interval training . During submaximal exercise a significant decrease was observed in lactic acid production , being most pronounced in the C-trained group ( -31 % , p<0.01 versus -20 % , p<0.05 ) . Only in the I-trained group did a significant increase in peak work load ( 17 % , p<0.05 ) and a decrease in leg pain ( p<0.05 ) occur . Training did not result in a significant improvement in lung function , but maximal inspiratory mouth pressure increased in both groups by 10 % ( C : p<0.05 ) and 23 % ( I : p<0.01 ) . The present study shows a different physiological response pattern to interval or continuous training in chronic obstruction pulmonary disease , which might be a reflection of specific training effects in either oxidative or glycolytic muscle metabolic pathways . Further work is required to determine the role of the different exercise programmes and the particular category of patients for whom this might be beneficial We studied the impact of a 6-wk supervised , multimodality endurance exercise training program ( EXT ) on strength and endurance of ventilatory and peripheral muscles in patients with chronic airflow limitation ( CAL ) , and determined whether potential improvements contributed to relief of exertional breathlessness ( B ) and perceived leg effort/discomfort ( LE ) , respectively . Twenty breathless patients with stable CAL ( FEV1 = 41 + /- 3 % predicted ; mean + /- SEM ) were tested at 6-wk intervals at baseline , after a nonintervention control period ( pre-EXT ) , and post-EXT . Measurements included : pulmonary function tests ( PFTs ) , maximal inspiratory/expiratory pressures ( MIP , MEP ) , inspiratory muscle endurance ( V(LIM ) ) , quadriceps strength and endurance , exercise endurance , and submaximal cycle exercise with cardioventilatory and symptom responses . Measurements at baseline and pre-EXT were identical . Post-EXT , PFTs did not change ; exercise endurance measured on the treadmill , cycle ergometer , arm ergometer , and by 6-min walk distance increased 40 + /- 8 % , 43 + /- 10 % , 12 + /- 5 % , and 34 + /- 9 % , respectively ( p < 0.05 ) ; quadriceps strength increased 21 + /- 5 % ( p < 0.01 ) ; MIP and MEP increased 29 + /- 11 % and 27 + /- 11 % , respectively ( p < 0.05 ) ; V(LIM ) increased almost threefold ( p < 0.05 ) . At isotime near end-exercise , B , LE , carbon dioxide production ( VCO2 ) , oxygen consumption ( VO2 ) , ventilation , and breathing frequency ( F ) all fell after EXT ( p < 0.05 ) : deltaB correlated with deltaF ( r = 0.58 , p < 0.01 ) . Increased MIP and V(LIM ) did not correlate with improved breathlessness or exercise endurance . Similarly , changes in quadriceps strength and endurance did not correlate with changes in LE or exercise endurance . In conclusion , general nonspecific EXT improved ventilatory and peripheral muscle function in severe CAL , but such improvements did not appear to contribute significantly to reduced exertional symptoms and enhanced exercise performance In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials QUESTIONS Does an eight-week program of walk training improve endurance walking capacity in people with COPD compared to cycle training ? Does walk training improve peak walking capacity , cycle capacity , and quality of life compared to cycle training ? Is the endurance shuttle walk test ( ESWT ) responsive to change in walking capacity elicited by exercise training ? DESIGN R and omised trial with concealed allocation , assessor blinding , and intention-to-treat analysis . PARTICIPANTS 36 people with stable COPD recruited with four dropouts . INTERVENTION Participants were r and omised into either a walk or cycle training group . Both groups trained indoors for 30 to 45 minutes per session , three times weekly over eight weeks at Concord Hospital . Training intensities were based on baseline peak exercise tests and progressed as able . OUTCOME MEASURES The primary outcome was endurance walking capacity measured by the ESWT . Secondary outcomes included peak walking capacity , peak and endurance cycle capacity , and health-related quality of life . Measures were taken at baseline ( Week 0 ) and following training ( Week 8) . RESULTS The walk training group increased their endurance walking time by 279 seconds ( 95 % CI 70 to 483 ) more than the cycle training group . No significant differences between the groups were found for any other outcome . CONCLUSION Ground walk training increased endurance walking capacity more than cycle training and was similar to cycle training in improving peak walking capacity , peak and endurance cycle capacity and quality of life . This study provides evidence for ground walking as a mode of exercise training in pulmonary rehabilitation programs We studied high intensity , symptom-limited , endurance exercise training in 52 patients with COPD participating in a pulmonary rehabilitation program . The patients had moderate to severe airway obstruction and reduced exercise tolerance with ventilatory limitation . The target workload for endurance exercise testing was 95 percent of the baseline maximum treadmill work load . At training weeks 1 , 4 and 8 , they were training at 85 , 84 , and 86 percent respectively , of baseline maximum . After rehabilitation , there was an increase in maximal treadmill work load , VO2max , and endurance exercise time , and a decrease in perceived symptoms . Patients who did not reach anaerobic threshold ( group 2 ) were able to train at a higher percentage of maximum exercise tolerance than patients who reached anaerobic threshold ( group 1 ) . The increase in exercise performance of both groups , however , was similar . We conclude that patients with moderate to severe COPD can perform exercise training successfully at intensity targets which represent higher percentages of maximum than typically recommended in normal individuals or other patients Our objective was to compare the effect of a 4−week homebased low and middle intensity and frequency training program in patients with moderate to severe chronic obstructive pulmonary disease . From 124 patients hospitalized with chronic obstructive lung disease ( COPD ) in an 18-month period 65 fulfilled the inclusion criteria and were invited to participate . Only 31 ( 48 % ) accepted and among these only 20 patients ( 31 % of invited ) completed the 4-week study period . The walking time in seconds in a st and ardized treadmill walking test was unchanged after 4 weeks of low intensity training 60 minutes per week for two weekly training sessions . In contrast , the walking time in seconds increased 55 % ( p < 0.001 ) from 321 seconds to 499 seconds in 9 patients who completed 4 weeks of middle intensity training which comprised 21/2 hours of training per week for 5 weekly training sessions . There was no change in lung function over the 4 weeks but the combined score for physical quality of life ( physical component summary ) measured by SF-36 increased ( p < 0.05 ) with both low intensity and middle intensity physical training . In conclusion , homebased physical training , which aims at improvements in patient performance and quality of life as part of pulmonary rehabilitation programs , is only accepted by about one-third of unselected patients with moderate to severe COPD . The minimum training time necessary to improve physical performance is 2–3 hours per week of middle intensity training AIM In this study , the effects of a 12-week hospital-based outpatient pulmonary rehabilitation program ( HRP ) are compared with those of a 12-week home-care rehabilitation program ( HCRP ) in COPD patients . A control group received no rehabilitation therapy . METHODS After r and omization and stratification , effects on lung function , exercise performance ( 4-min walking test and cycle ergometer test ) , dyspnea , and leg effort during exercise , and well-being were assessed in 45 COPD patients with moderate to severe airflow limitation ( mean [ SD ] FEV1 percent predicted , 42.8 [ 8.4 ] ) . RESULTS After HRP and HCRP , at 3 to 6 months after the start of the study , equal improvements were detected in exercise capacity and in Borg dyspnea and leg effort scores at similar work levels during the cycle test . However , whereas after HRP at longer term values tended to return to baseline outcome , after HCRP a further ongoing significant improvement in exercise capacity was observed , while Borg dyspnea scores remained significantly improved over 18 months . Improvements in cycle workload and dyspnea score were significantly better maintained after HCRP as compared with HRP . Lung function , arterial oxygen saturation , and heart frequency during exercise did not change . A significant improvement in well-being was maintained over 18 months in both rehabilitation groups . CONCLUSION Beneficial effects are achieved both after a HRP and a HCRP in COPD patients with moderate to severe airflow limitation . Yet we recommend to initiate HCRPs as improvements are maintained longer and are even further strengthened in this setting This r and omized , controlled study investigated the physiological effects of a specially design ed 12 week programme of isolated conditioning of peripheral skeletal muscle groups . The programme required minimal infrastructure in order to allow continued rehabilitation at home after familiarization within hospital . Forty eight patients , aged 40 - 72 yrs with chronic obstructive pulmonary disease ( COPD ) ( mean ( SD ) forced expiratory volume in one second ( FEV1 ) 61 (27)% of predicted normal ) were r and omly allocated into training ( n = 32 ) and control ( n = 16 ) groups . Physiological assessment s were performed before and after the 12 week study period , and included peripheral muscle endurance and strength , whole body endurance , maximal exercise capacity ( maximum oxygen consumption ( V'O2,max ) ) and lung function . The training group showed significant improvement in a variety of measures of upper and lower peripheral muscle performance , with no additional breathlessness . Whole body endurance measured by free arm treadmill walking increased by 6,372 ( 3,932 - 8,812 ) 3 ( p < 0.001 ) . Symptom-limited maximal V'O2 was unchanged . However , the training group showed a reduction in ventilatory equivalents for oxygen and carbon dioxide , both at peak exercise and at equivalent work rate ( Wmax ) . In summary , low intensity isolated peripheral muscle conditioning is well-tolerated , simple and easy to perform at home . The various physiological benefits should enable patients across the
Output:
| Consequently , there are insufficient data to draw any conclusions on exercise capacity , symptoms and HRQoL for this comparison .
For comparisons between continuous and interval training , both appear to be equally effective in improving exercise capacity , symptoms and |
MS213455 | ***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 : Single small enhancing CT lesions ( SSECTL ) of the brain with or without perifocal oedema are common in patients with symptomatic epilepsy in India . Solitary cysticercus granuloma , a benign form of parenchymal neurocysticercosis , is considered to be the most common aetiology for SSECTL . Definite information is lacking regarding the effectiveness of antiparasitic treatment on resolution of these lesions and on long term seizure recurrence . Objective : To evaluate the response to albendazole treatment in patients who had SSECTL and new onset seizures treated with antiepileptic drugs ( AED ) in a prospect i ve clinical trial . Methods : 43 patients who presented with new onset seizures and were documented to have SSECTL were alternatively allocated to receive albendazole 15 mg/kg/day for 2 weeks or no cysticidal therapy . All patients were treated with AED and followed for at least 6 months for seizure recurrence , and serial CT scans were obtained at 4 weeks , 3 months and at study completion . Results : 28 ( 65 % ) patients were aged 5–25 years and 31 ( 72 % ) presented clinical ly with partial motor seizures with or without generalisation . Most of the SSECTL were ring lesions ( 75 % ) and located in and around the sensory – motor cortex at the gray – white junction ( 65 % ) . In the albendazole group , 56 % of patients compared with 35 % in the control group showed resolution of SSECTL ( p = 0.154 ) at 1 month . 22 of 23 patients ( 95.6 % ) , who received albendazole , compared with 14 of 20 patients ( 70 % ) in the control group , demonstrated radiological resolution on study completion ( p = 0.03 ) . Punctate residual calcification and seizure recurrence were observed in four patients ( 9.3 % ) in the control group and in three ( 7 % ) patients in the albendazole group ( p = 0.47 ) . Conclusions : In patients presenting with seizures due to single viable parenchymal neurocysticercosis , albendazole hastens the resolution of SSECTL if treatment is given in the early phase of the illness Twenty-six patients with single enhancing brain lesion ( SEL ) were openly assigned to receive single-day praziquantel therapy ( n=14 ) , or not ( n=12 ) . From 14 treated patients , complete resolution was found in 11 , partial resolution in two , and the remaining case was later diagnosed as an arteriovenous malformation . Side effects presented in only one patient and remitted in the same day with symptomatic treatment . Conversely , the lesions persisted unchanged in six of 12 patients in the non-treatment group . Untreated patients with persisting lesions were prescribed praziquantel treatment . After this , SELs disappeared in three cases , other diagnoses ( brain tuberculoma and arteriovenous malformation ) were made in two , and one was not evaluated . When analyzed in regard to the baseline serology , resolution of lesions on computed tomography was found in 13 ( complete=12 , partial=1 ) of 14 seropositive patients , whereas it only happened in six ( complete=5 , partial=1 ) of 12 seronegative patients . Serological screening defines a subset of SEL patients with good prognosis . If antiparasitic therapy is to be used in patients with SEL , and we can not find a strong argument against it , single-day praziquantel is the regimen of choice based on duration , costs , and minimal side effects No trials to date have focused on long-term seizure outcome in solitary cerebral cysticercal lesion ( SCCL ) , which is believed to produce a relatively benign form of epilepsy . This is a prospect i ve r and omized controlled study to evaluate the effect of Albendazole on long-term seizure outcome in patients with MRI-confirmed solitary cerebral cysticercal lesion ( SCCL ) . One hundred and twenty-three patients with new-onset seizures and SCCL on contrast MRI were r and omized to treatment with albendazole and followed for up to five years with serial MRI and clinical evaluation . At final analysis 103 patients ( M-54 , F-49 ) with a mean age of 18.6+/-10.7 years and follow-up period more than 12 months were included . The mean follow-up duration was 31.4+/-14.8 months ( 12 - 64 ) . At one month follow-up more patients receiving albendazole were seizure-free ( 62 % versus 49 % for controls ) . Subsequently there was no significant difference in overall seizure outcome between the two groups . There was no correlation between seizure semiology , albendazole therapy and long-term seizure outcome . Baseline MRI showed active lesions in all ; 23 % remained active at 12 months with no difference between the albendazole and control groups . Patients whose lesions resolved at 12 months showed better seizure outcome . Reduction in mean cyst area was greater in the albendazole group as compared to the controls and the difference at six months was significant ( p<0.05 ) . At three months follow-up perilesional edema also resolved faster in albendazole group ( p<0.05 ) . Thus , albendazole did not alter the long-term seizure outcome in patients with SCCL and epilepsy . However , albendazole hastened resolution of SCCL on MRI , but interestingly 23 % of lesions were still active 12 months after treatment Objectiue To compare the effectiveness of two regimens of albendazole therapy for neurocysticercosis . Design R and omized , double-blind clinical trial . Setting s Patients admitted to neurologic wards in Lima , Peru . Patients Adult patients with active neurocysticercosis demonstrated by CT and Western blot ( immunoblot ) . Intervention One week ( n = 25 ) versus 2 weeks ( n = 25 ) of albendazole therapy . Measurements Decrease in the number of cysts on CT . Results Effectiveness of albendazole was 78 % , with no difference between the groups when compared 3 months after therapy . Complete cure was obtained in only 38 % of patients . Patients with more than 20 cysts had poorer responses to therapy . The clinical course and EEG evolution improved in most patients . Side effects were present in 38 % of patients , mainly mild , transient gastrointestinal symptoms . Therapy was also associated with exacerbation of neurologic symptoms . Two patients died in the first year after therapy , both because of aggregated infections of ventricle-peritoneal shunts . One-year follow-up CT showed lesions in three of 10 patients presumed to be cured 3 months after therapy . Conclusions Extension of albendazole therapy for more than 7 days adds no benefits for the patients KEY WORDS : Neurocysticercosis : Albendazole ; Dextrochloropheniramine ; Treatment . The clinical variability of neurocysticercosis is due to a series of factors such as number , location , form , dimensions and stage of development of the parasite , the nature of its action on the organism and the individual immunological response of the hosu.4,6 . Thus , diagnosis is very difficult , especially in not highly endemic areas or in regions were laboratory support is lacking . Another important feature to be considered in the approach to neurocysticercosis is the lack of an alternative program of antiparasitic treatment . The high coast of treatment with praziquantel and the side effects ' of
Output:
| In the natural history of neurocysticercosis , the following stages of evolution of parenchymal larval cysts can be observed on neuroimaging : viable cyst , granulomatous cysticercosis and disappearance of cyst with or without residual calcification.2 In the viable cyst stage , the cyst wall is not visible on imaging and the cyst demonstrates little or no perilesional oedema .
Ring-like or nodular areas of enhancement with prominent perilesional oedema mark the phase of granulomatous cysticercosis .
The image shown here demonstrates the granulomatous cysticercosis as a ring-enhancing lesion with scolex and peri-lesional oedema .
Ultimately , the remnant of the cyst is either not visible on the imaging or observed as calcified lesion(s ) .
A single day course of praziquantel has also been employed.7 Surgery is usually reserved for extraparenchymal neurocysticercosis such as an intraventricular cyst , spinal cysticercosis causing spinal cord compression , for hydrocephalus , or for ophthalmic cysticercosis.8 In general , the seizure outcome in solitary cerebral cysticercosis is good in view of the symptomatic nature of the seizure . |
MS213456 | ***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 / Objectives : Evidence about the relation between dietary patterns and cardiovascular disease ( CVD ) is scarce in Middle Eastern countries . This study was performed to examine the association between major dietary patterns and CVD mortality in Iranian adults . Subjects/ Methods : This population -based prospect i ve cohort study was conducted among 4834 r and omly selected participants aged ⩾35 years from urban and rural areas of central Iran ( 2001–2009 ) ( the Isfahan Cohort Study ) . Dietary intakes were assessed using a food frequency question naire , and major dietary patterns were identified by means of exploratory factor analysis . Subjects or their next of kin were interviewed biannually looking for possible occurrence of events . Cardiovascular mortality was defined as fatal myocardial infa rct ion , fatal stroke and sudden cardiac death . Results : During the median follow-up of 9.0 years and 50 282 person-years , we found a total of 118 CVD mortalities . Four major dietary patterns were identified : ' Western ' , ' Mediterranean ' , ' Animal fat ' and ' Fast food ' . Adherence to the Mediterranean dietary pattern was protectively associated with CVD mortality , such that those in the highest quartile were 46 % ( hazard ratio ( HR ) : 0.54 ; 95 % confidence interval ( CI ) : 0.32–0.91 ; P-value for trend=0.03 ) less likely to have incident CVD mortality than those in the lowest quartile . Further adjustment for potential confounders strengthened this association ( HR : 0.42 ; 95 % CI : 0.19–0.96 ; P-value for trend=0.02 ) . We found no significant association between adherence to the Western , animal fat and fast food dietary patterns and CVD mortality . Conclusions : Adherence to a Mediterranean dietary pattern was associated with reduced risk for cardiovascular mortality even in a developing country setting Diet rich in fruits , vegetables , and dairy products , known as the Dietary Approaches to Stop Hypertension ( DASH ) diet , is known to reduce blood pressure ( BP ) in hypertensive patients . More recently , the DASH diet was shown to reduce oxidative stress in hypertensive and nonhypertensive humans . However , the main nutritional components responsible for these beneficial effects of the DASH diet remain unknown . Because the DASH diet is rich in potassium ( K ) , magnesium ( Mg ) , and alkali , we performed a r and omized , double-blinded , placebo-controlled study to compare effects of potassium magnesium citrate ( KMgCit ) , potassium chloride ( KCl ) , and potassium citrate ( KCit ) to allow dissociation of the three components of K , Mg , and citrate on 24-hour ambulatory BP and urinary 8-isoprostane in hypertensive and prehypertensive subjects , using a r and omized crossover design . We found that KCl supplementation for 4 weeks induced a significant reduction in nighttime SBP compared with placebo ( 116 ± 12 vs 121 ± 15 mm Hg , respectively , p < 0.01 vs placebo ) , whereas KMgCit and KCit had no significant effect in the same subjects ( 118 ± 11 and 119 ± 13 mm Hg , respectively , p > 0.1 vs placebo ) . In contrast , urinary 8-isoprostane was significantly reduced with KMgCit powder compared with placebo ( 13.5 ± 5.7 vs 21.1 ± 10.5 ng/mgCr , respectively , p < 0.001 ) , whereas KCl and KCit had no effect ( 21.4 ± 9.1 and 18.3 ± 8.4 , respectively , p > 0.1 vs placebo ) . In conclusion , our study demonstrated differential effects of KCl and KMgCit supplementation on BP and the oxidative stress marker in prehypertensive and hypertensive subjects . Clinical significance of the antioxidative effect of KMgCit remains to be determined in future studies OBJECTIVES This study sought to determine the efficacy of dietary sodium restriction ( DSR ) for improving vascular endothelial dysfunction in middle-aged/older adults with moderately elevated systolic blood pressure ( SBP ) ( 130 - 159 mm Hg ) and the associated physiological mechanisms . BACKGROUND Vascular endothelial dysfunction develops with advancing age and elevated SBP , contributing to increased cardiovascular risk . DSR lowers BP , but its effect on vascular endothelial function and mechanisms involved are unknown . METHODS Seventeen subjects ( 11 men and 6 women ; mean age , 62 ± 7 years ) completed a , r and omized crossover study of 4 weeks of both low ( DSR ) and normal sodium intake . Vascular endothelial function ( endothelium-dependent dilation ; EDD ) , nitric oxide (NO)/tetrahydrobiopterin ( BH(4 ) ) bioavailability , and oxidative stress-associated mechanisms were assessed following each condition . RESULTS Urinary sodium excretion was reduced by ≈ 50 % ( to 70 ± 30 mmol/day ) , and conduit ( brachial artery flow-mediated dilation [ FMD(BA ) ] ) and resistance ( forearm blood flow responses to acetylcholine [ FBF(ACh ) ] ) artery EDD were 68 % and 42 % ( peak FBF(ACh ) ) higher following DSR ( p < 0.005 ) . Low sodium markedly enhanced NO-mediated EDD ( greater ΔFBF(ACh ) with endothelial NO synthase inhibition ) without changing endothelial NO synthase expression/activation ( Ser 1177 phosphorylation ) , restored BH(4 ) bioactivity ( less ΔFMD(BA ) with acute BH(4 ) ) , abolished tonic superoxide suppression of EDD ( less ΔFMD(BA ) and ΔFBF(ACh ) with ascorbic acid infusion ) , and increased circulating superoxide dismutase activity ( all p < 0.05 ) . These effects were independent of ΔSBP . Other subject characteristics/dietary factors and endothelium-independent dilation were unchanged . CONCLUSIONS DSR largely reversed both macro- and microvascular endothelial dysfunction by enhancing NO and BH(4 ) bioavailability and reducing oxidative stress . Our findings support the emerging concept that DSR induces " vascular protection " beyond that attributable to its BP-lowering effects BACKGROUND The incidence of congestive heart failure ( CHF ) has been increasing steadily in the United States during the past 2 decades . We studied risk factors for CHF and their corresponding attributable risk in the First National Health and Nutrition Examination Survey Epidemiologic Follow-up Study . PARTICIPANTS AND METHODS A total of 13 643 men and women without a history of CHF at baseline examination were included in this prospect i ve cohort study . Risk factors were measured using st and ard methods between 1971 and 1975 . Incidence of CHF was assessed using medical records and death certificates obtained between 1982 and 1984 and in 1986 , 1987 , and 1992 . RESULTS During average follow-up of 19 years , 1382 CHF cases were documented . Incidence of CHF was positively and significantly associated with male sex ( relative risk [ RR ] , 1.24 ; 95 % confidence interval [ CI ] , 1.10 - 1.39 ; P<.001 ; population attributable risk [ PAR ] , 8.9 % ) , less than a high school education ( RR , 1.22 ; 95 % CI , 1.04 - 1.42 ; P = .01 ; PAR , 8.9 % ) , low physical activity ( RR , 1.23 ; 95 % CI , 1.09 - 1.38 ; P<.001 ; PAR , 9.2 % ) , cigarette smoking ( RR , 1.59 ; 95 % CI , 1.39 - 1.83 ; P<.001 ; PAR , 17.1 % ) , overweight ( RR , 1.30 ; 95 % CI , 1.12 - 1.52 ; P = .001 ; PAR , 8.0 % ) , hypertension ( RR , 1.40 ; 95 % CI , 1.24 - 1.59 ; P<.001 ; PAR , 10.1 % ) , diabetes ( RR , 1.85 ; 95 % CI , 1.51 - 2.28 ; P<.001 ; PAR , 3.1 % ) , valvular heart disease ( RR , 1.46 ; 95 % CI , 1.17 - 1.82 ; P = .001 ; PAR , 2.2 % ) , and coronary heart disease ( RR , 8.11 ; 95 % CI , 6.95 - 9.46 ; P<.001 ; PAR , 61.6 % ) . CONCLUSIONS Male sex , less education , physical inactivity , cigarette smoking , overweight , diabetes , hypertension , valvular heart disease , and coronary heart disease are all independent risk factors for CHF . More than 60 % of the CHF that occurs in the US general population might be attributable to coronary heart disease Background Despite convincing evidence in the Mediterranean region , the cardiovascular benefit of the Mediterranean diet is not well established in non-Mediterranean countries and the optimal criteria for defining adherence are unclear . The population attributable fraction ( PAF ) of adherence to this diet is also unknown . Methods In the UK-based EPIC-Norfolk prospect i ve cohort , we evaluated habitual diets assessed at baseline ( 1993–1997 ) and during follow-up ( 1998–2000 ) using food-frequency question naires ( n = 23,902 ) . We estimated a Mediterranean diet score ( MDS ) using cut-points projected from the Mediterranean dietary pyramid , and also three other pre-existing MDSs . Using multivariable-adjusted Cox regression with repeated measures of MDS and covariates , we examined prospect i ve associations between each MDS with incident cardiovascular diseases ( CVD ) by 2009 and mortality by 2013 , and estimated PAF for each outcome attributable to low MDS . Results We observed 7606 incident CVD events ( 2818/100,000 person-years ) and 1714 CVD deaths ( 448/100,000 ) . The MDS based on the Mediterranean dietary pyramid was significantly associated with lower incidence of the cardiovascular outcomes , with hazard ratios ( 95 % confidence intervals ) of 0.95 ( 0.92–0.97 ) per one st and ard deviation for incident CVD and 0.91 ( 0.87–0.96 ) for CVD mortality . Associations were similar for composite incident ischaemic heart disease and all-cause mortality . Other pre-existing MDSs showed similar , but more modest associations . PAF due to low dietary pyramid based MDS ( < 95th percentile ) was 3.9 % ( 1.3–6.5 % ) for total incident CVD and 12.5 % ( 4.5–20.6 % ) for CVD mortality . Conclusions Greater adherence to the Mediterranean diet was associated with lower CVD incidence and mortality in the UK . This diet has an important population health impact for the prevention of CVD BACKGROUND The possible advantage for weight loss of a diet that emphasizes protein , fat , or carbohydrates has not been established , and there are few studies that extend beyond 1 year . METHODS We r and omly assigned 811 overweight adults to one of four diets ; the targeted percentages of energy derived from fat , protein , and carbohydrates in the four diets were 20 , 15 , and 65 % ; 20 , 25 , and 55 % ; 40 , 15 , and 45 % ; and 40 , 25 , and 35 % . The diets consisted of similar foods and met guidelines for cardiovascular health . The participants were offered group and individual instructional sessions for 2 years . The primary outcome was the change in body weight after 2 years in two-by-two factorial comparisons of low fat versus high fat and average protein versus high protein and in the comparison of highest and lowest carbohydrate content . RESULTS At 6 months , participants assigned to each diet had lost an average of 6 kg , which represented 7 % of their initial weight ; they began to regain weight after 12 months . By 2 years , weight loss remained similar in those who were assigned to a diet with 15 % protein and those assigned to a diet with 25 % protein ( 3.0 and 3.6 kg , respectively ) ; in those assigned to a diet with 20 % fat and those assigned to a diet with 40 % fat ( 3.3 kg for both groups ) ; and in those assigned to a diet with 65 % carbohydrates and those assigned to a diet with 35 % carbohydrates ( 2.9 and 3.4 kg , respectively ) ( P>0.20 for all comparisons ) . Among
Output:
| The DASH pattern showed improvement in cardiac function , functional capacity , blood pressure , oxidative stress and mortality .
The Mediterranean diet had a correlation with inflammation , quality of life and cardiac function but just on cross-sectional studies .
Conclusions : DASH pattern may have benefits in the secondary prevention of HF .
In addition , the Hyperproteic and Low-carb diets , despite the lack of studies , also demonstrated positive effects on the functional capacity in patients with HF |
MS213457 | ***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: Computer-administered cognitive training ( CT ) tasks are a common component of cognitive remediation treatments . There is growing evidence that transcranial direct current stimulation ( tDCS ) , when given during cognitive tasks , improves performance . This r and omized , controlled trial explored the potential synergistic effects of CT combined with tDCS in healthy participants . Altogether , 60 healthy participants were r and omized to receive either active or sham tDCS administered during training on an adaptive CT task ( dual n-back task ) , or tDCS alone , over 10 daily sessions . Cognitive testing ( working memory , processing speed , executive function , reaction time ) was conducted at baseline , end of the 10 sessions , and at 4-wk follow-up to examine potential transfer effects to non-trained tasks . Altogether , 54 participants completed the study . Over the 10 ' online ' sessions , participants in the active tDCS+CT condition performed more accurately on the CT task than participants who received sham tDCS+CT . The performance enhancing effect , however , was present only during tDCS and did not result in greater learning ( i.e. improvement over sessions ) on the CT task . These results confirm prior reports of enhancement of cognitive function during tDCS stimulation . At follow-up , the active tDCS+CT group , but not the sham tDCS+CT group , showed greater gains on a non-trained test of attention and working memory than the tDCS-only group ( p < 0.01 ) . Although this gain can mainly be attributable to training , this result suggests that active tDCS may have a role in further enhancing outcomes BACKGROUND Subjects with a mild cognitive impairment ( MCI ) have a memory impairment beyond that expected for age and education yet are not demented . These subjects are becoming the focus of many prediction studies and early intervention trials . OBJECTIVE To characterize clinical ly subjects with MCI cross-sectionally and longitudinally . DESIGN A prospect i ve , longitudinal inception cohort . SETTING General community clinic . PARTICIPANTS A sample of 76 consecutively evaluated subjects with MCI were compared with 234 healthy control subjects and 106 patients with mild Alzheimer disease ( AD ) , all from a community setting as part of the Mayo Clinic Alzheimer 's Disease Center/Alzheimer 's Disease Patient Registry , Rochester , Minn. MAIN OUTCOME MEASURES The 3 groups of individuals were compared on demographic factors and measures of cognitive function including the Mini-Mental State Examination , Wechsler Adult Intelligence Scale-Revised , Wechsler Memory Scale-Revised , Dementia Rating Scale , Free and Cued Selective Reminding Test , and Auditory Verbal Learning Test . Clinical classifications of dementia and AD were determined according to the Diagnostic and Statistical Manual of Mental Disorders , Revised Third Edition and the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer 's Disease and Related Disorders Association criteria , respectively . RESULTS The primary distinction between control subjects and subjects with MCI was in the area of memory , while other cognitive functions were comparable . However , when the subjects with MCI were compared with the patients with very mild AD , memory performance was similar , but patients with AD were more impaired in other cognitive domains as well . Longitudinal performance demonstrated that the subjects with MCI declined at a rate greater than that of the controls but less rapidly than the patients with mild AD . CONCLUSIONS Patients who meet the criteria for MCI can be differentiated from healthy control subjects and those with very mild AD . They appear to constitute a clinical entity that can be characterized for treatment interventions Objective : Given the limited effectiveness of pharmacological treatments , non-pharmacological interventions to treat Alzheimer 's disease ( AD ) have gained attention in recent years . The aim of the present study is to investigate the effects of anodal tDCS ( AtDCS ) combined with memory training on face-name associations in an AD patient sample . Methods : Thirty six AD patients were r and omly assigned to one of three study groups : Group 1 , AtDCS plus individualized computerized memory training ; Group 2 , placebo tDCS plus individualized computerized memory training ; Group 3 , AtDCS plus motor training . Results : A general improvement in performance was observed after 2 weeks of memory training . Both the anodal tDCS plus individualized computerized memory training and the placebo tDCS plus individualized computerized memory training groups had significantly improved performances at 2 weeks compared with the AtDCS plus motor training group . Conclusion : Our findings suggest a beneficial effect of individualized memory rehabilitation in AD patients The capacity for transcranial direct current stimulation ( tDCS ) to increase learning and cognition shows promise for the development of enhanced therapeutic interventions . One potential application is the combination of tDCS with cognitive training ( CT ) , a psychological intervention which aims to improve targeted cognitive abilities . We have previously shown that tDCS enhanced performance accuracy , but not skill acquisition , on a dual n-back working memory ( WM ) CT task over repeated sessions . In the current study , we investigated the optimal timing for combining tDCS with the same CT task to enhance within and between session performance outcomes across two daily CT sessions . Twenty healthy participants received in a r and omised order 30 min of anodal tDCS to the left dorsolateral prefrontal cortex immediately before ( ‘ offline ’ tDCS ) and during performance ( ‘ online ’ tDCS ) on a dual n-back WM CT task , in an intra-individual crossover design . Analyses examined within and between session consolidation effects of tDCS on CT performance outcomes . Results showed that ‘ online ’ tDCS was associated with better within session skill acquisition on the CT task , with a significant difference found between conditions the following day . These results suggest that ‘ online ’ tDCS is superior to ‘ offline ’ tDCS for enhancing skill acquisition when combining anodal tDCS with CT . This finding may assist with the development of enhanced protocol s involving the combination of tDCS with CT and other rehabilitation protocol Background : The purpose of this study was to investigate the long-term efficacy of transcranial direct current stimulation ( tDCS ) in the neurorehabilitation of Alzheimer ’s disease ( AD ) . Methods : Thirty-four AD patients were r and omly assigned to three groups : anodal , cathodal , and sham tDCS . Stimulation was applied over the left dorsolateral prefrontal cortex for 25 min at 2 mA , daily for 10 days . Each patient was su bmi tted to the following psychometric assessment s : mini-mental state examination ( MMSE ) and Wechsler adult intelligence scale-third edition at base line , at the end of the 10th sessions and then at 1 and 2 months after the end of the sessions . Motor cortical excitability and the P300 event-related potential were assessed at baseline and after the last tDCS session . Results : Significant treatment group × time interactions were observed for the MMSE and performance IQ of the WAIS . Post hoc comparisons showed that both anodal and cathodal tDCS ( ctDCS ) improved MMSE in contrast to sham tDCS . Whereas , this was only true for ctDCS in the performance IQ . Remarkably , tDCS also reduced the P300 latency , but had no effect on motor cortex excitability . Conclusion : Our findings reveal that repeated sessions of tDCS could not only improve cognitive function but also reduce the P300 latency , which is known to be pathologically increased in AD Background There has been longst and ing interesting in cognitive training for older adults with cognitive impairment . In this study , we will investigate the effects of working memory training , and explore augmentation strategies that could possibly consoli date the effects in older adults with mild neurocognitive disorder . Transcranial direct current stimulation ( tDCS ) has been demonstrated to affect the neuronal excitability and reported to enhance memory performance . As tDCS may also modulate cognitive function through changes in neuroplastic response , it would be adopted as an augmentation strategy for working memory training in the present study . Methods / Design This is a 4-week intervention double-blind r and omized controlled trial ( RCT ) of tDCS . Chinese older adults ( aged 60 to 90 years ) with mild neurocognitive disorder due to Alzheimer ’s disease ( DSM-5 criteria ) would be r and omized into a 4-week intervention of either tDCS-working memory ( DCS-WM ) , tDCS-control cognitive training ( DCS-CC ) , and sham tDCS-working memory ( WM-CD ) groups . The primary outcome would be working memory test – the n-back task performance and the Chinese version of the Alzheimer ’s Disease Assessment Scale – Cognitive Subscale ( ADAS-Cog ) . Secondary outcomes would be test performance of specific cognitive domains and mood . Intention-to-treat analysis would be carried out . Changes of efficacy indicators with time and intervention would be tested with mixed effect models . Discussion This study adopts the theory of neuroplasticity to evaluate the potential cognitive benefits of non-invasive electrical brain stimulation , working memory training and dual stimulation in older adults at risk of cognitive decline . It would also examine the tolerability , program adherence and adverse effects of this novel intervention . Information would be helpful for further research of dementia prevention studies .Trial registration ChiCTR-TRC-14005036 Date of registration : 31 July 2014 Background The purpose of this study was to assess the efficacy of transcranial direct current stimulation ( tDCS ) on verbal memory function in patients with Alzheimer ’s disease . Methods We conducted a r and omized , placebo-controlled clinical trial in which tDCS was applied in six 30-minute sessions for 10 days . tDCS was delivered to the left temporal cortex with 2-mA intensity . A total of 25 patients with Alzheimer ’s disease were enrolled in the study . All of the patients were diagnosed according to National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer ’s Disease and Related Disorders Association criteria . Twelve patients received active stimulation , and thirteen patients received placebo stimulation . The primary outcome measure was the change in two parallel versions of the California Verbal Learning Test – Second Edition , a st and ardized neuropsychological memory test normalized by age and gender . The secondary outcome measures were the Mini Mental State Examination , clock-drawing test , and Trail Making Test A and B. Results Changes in the California Verbal Learning Test – Second Edition scores were not significantly different between the active and placebo stimulation groups for immediate recall ( p = 0.270 ) , delayed recall ( p = 0.052 ) , or recognition ( p = 0.089 ) . There were nonsignificant differences in score changes on the Mini Mental State Examination ( p = 0.799 ) , clock-drawing test ( p = 0.378 ) , and Trail Making Test A ( p = 0.288 ) and B ( p = 0.093 ) . Adverse effects were not observed . Conclusions Compared with placebo stimulation , active tDCS stimulation in this clinical trial did not significantly improve verbal memory function in Alzheimer ’s disease . This study differs from previous studies in terms of the stimulation protocol , trial design , and application of st and ardized neuropsychological memory assessment .Trial registration Clinical Trials.gov identifier NCT02518412 . Registered on 10 August 2015 Background and Purpose To investigate whether transcranial direct-current stimulation ( tDCS ) can improve cognition in stroke patients . Methods Forty-five stroke patients ( 20 males and 25 females , average age : 62.7 years ) with cognitive dysfunction were included in this prospect i ve , double-blinded , r and omized case – control study . All patients were right-h and ed and the mean elapsed time after stroke was 39.3 days . Three different treatments groups were used : ( 1 ) anodal stimulation of the left anterior temporal lobe , ( 2 ) anodal stimulation of the right anterior temporal lobe , and ( 3 ) sham stimulation . tDCS was delivered for 30 minutes at 2 mA with 25 cm2 electrodes , five times/week , for a total of 3 weeks , using a Phoresor II Auto Model PM 850 ( IOMED ® ) . The evaluation of cognitive impairment was based on a Computerized Neuropsychological Test ( CNT ) , Korean Mini-Mental State Examination ( K-MMSE ) . The Korean version of the Modified Barthel Index ( K-MBI ) was used to assess activities of daily living functionality . These evaluations were conducted in all patients before and after treatment . Results Each group included 15 patients . Pre-treatment evaluation showed no significant differences between the three groups for any of the parameters . There was significant improvement in the verbal learning test on the CNT in the left anodal stimulation group ( P < 0.05 ) . There were , however , no significant differences in the K-MMSE or K-MBI scores among the three groups . Conclusions These results demonstrated the beneficial effects of anodal tDCS on memory function . Thus , tDCS can successfully be used as a treatment modality for patients with cognitive dysfunction after stroke 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 In spite of treatment advances , HIV infection is associated with cognitive deficits . This is even more important as many persons with HIV infection age and experience age-related cognitive impairments . Both computer-based cognitive training and transcranial direct current stimulation ( tDCS ) have shown promise as interventions to improve cognitive function . In this study , we investigate the acceptability and efficacy of cognitive training with and without tDCS in older persons with HIV . Patients and methods In this single-blind r and omized study , participants were 14 individuals of whom 11 completed study procedures
Output:
| At present , there is a lack of clear evidence concerning the efficacy of multisession anodal tDCS due to the small number of studies and different measures used . |
MS213458 | ***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 studies have shown good clinical results in patients with proximal humeral fractures ( PHFs ) treated with locking intramedullary nails or locking plates . Our study compared the clinical and radiographic outcomes in patients with 2- and 3-part surgical neck fractures . METHODS In this prospect i ve , r and omized controlled trial , 72 patients with 2- or 3-part surgical neck PHFs were r and omly assigned to receive fixation with locking intramedullary nails ( nail group ) or locking plates ( plate group ) . The primary outcome was the 12-month Constant-Murley score . The secondary outcomes included the Disabilities of the Arm , Shoulder and H and score , the visual analog scale pain score , the shoulder passive range of motion , the neck-shaft angle , and complication rates . RESULTS There was no significant mean treatment group difference in the Constant-Murley score at 12 months ( 70.3 points for the nail group vs. 71.5 points for the plate group ; P = .750 ) or at individual follow-up assessment s. There were no differences in the 3- , 6- and 12-month Disabilities of the Arm , Shoulder and H and scores , visual analog scale scores , and range of motion , except for the medial rotation at 6 months . The neck-shaft angle was equivalent between the groups at 12 months . There were significant differences over 12 months in total complication rates ( P = .002 ) and reoperation rates ( P = .041 ) . There were no significant differences for the rotator cuff tear rate ( P = .672 ) . CONCLUSION Fixation of PHFs with locking plates or locking intramedullary nails produces similar clinical and radiologic results . Nevertheless , the complication and reoperation rates were higher in the nail group Study Design A prospect i ve cohort study nested in a r and omized controlled trial . Objectives To determine and compare responsiveness and minimal clinical ly important change of the modified Constant score ( CS ) and the Oxford Shoulder Score ( OSS ) . Background The OSS and the CS are commonly used to assess shoulder outcomes . However , few studies have evaluated the measurement properties of the OSS and CS in terms of responsiveness and minimal clinical ly important change . Methods The study included 126 patients who reported having difficulty returning to usual activities 8 to 12 weeks after arthroscopic decompression surgery for subacromial impingement syndrome . The assessment at baseline and at 3 months included the OSS , the CS , and the European Quality of Life-5 Dimensions-3 Level ( EQ-5D-3L ) index . Responsiveness was assessed as follows : by correlation analysis between the change scores of the OSS , CS , and EQ-5D-3L index , and the Patient Global Impression of Change ( PGIC ) scale ; by receiver-operating-characteristic ( ROC ) curve analysis using the PGIC scale as an external anchor ; and by effect-size statistics . Results At 3 months , a follow-up assessment of 112 patients ( 89 % ) was conducted . The change scores of the CS and the OSS were more strongly correlated with the external anchor ( PGIC scale ) than the change score of the EQ-5D-3L index . The areas under the ROC curves exceeded 0.80 for both shoulder scores , with no significant differences between them , and comparable effect-size estimates were observed for the CS and the OSS . Minimal clinical ly important change ROC values were 6 points for the OSS and 11 points for the CS , with upper 95 % cutoff limits of 12 and 22 points , respectively . Conclusion The CS and the OSS were both suitable for assessing improvement after decompression surgery Purpose The aim of this study was to compare the functional outcome , quality of restoration , and complication rate after open reduction and internal fixation ( ORIF ) of displaced or unstable 2- , 3- and 4-part humeral fractures using two different locking plates . Methods The data used in this analysis was prospect ively collected in two large multicentre studies in 15 European Level 1 trauma centres . A total of 318 patients with proximal humeral fractures were treated with ORIF using either the locking proximal humerus plate ( LPHP ) or proximal humeral internal locking system ( PHILOS ) . Outcome measurements included Constant and Neer scores , evaluation of local pain at the fracture site and complications , and radiographic assessment at one year . Results At one year , the mean Constant scores ( relative to the contralateral shoulder ) improved significantly for both groups and were above 80 % for 2- , 3- , and 4-part fractures . A significantly shorter surgical time , less pain at the fracture site , and better functional outcome was achieved by PHILOS-treated patients with 2-part fractures throughout the one-year follow-up month and with 3-part fractures at three months ( p < 0.05 ) . There was no difference between the treatment outcomes for 4-part fractures , and no difference in the complication rates ( p > 0.05 ) . Conclusions PHILOS and LPHP can be considered as useful implants for ORIF of displaced and unstable proximal humeral fractures . There was a slight advantage of the PHILOS system with regard to operative time and functional outcome , especially for the treatment of 2- and 3-part fractures Aims The PROximal Fracture of the Humerus Evaluation by R and omisation ( PROFHER ) r and omised clinical trial compared the operative and non‐operative treatment of adults with a displaced fracture of the proximal humerus involving the surgical neck . The aim of this study was to determine the long‐term treatment effects beyond the two‐year follow‐up . Patients and Methods Of the original 250 trial participants , 176 consented to extended follow‐up and were sent postal question naires at three , four and five years after recruitment to the trial . The Oxford Shoulder Score ( OSS ; the primary outcome ) , EuroQol 5D‐3L ( EQ‐5D‐3L ) , and any recent shoulder operations and fracture data were collected . Statistical and economic analyses , consistent with those of the main trial were applied . Results OSS data were available for 164 , 155 and 149 participants at three , four and five years , respectively . There were no statistically or clinical ly significant differences between operative and non‐operative treatment at each follow‐up point . No participant had secondary shoulder surgery for a new complication . Analyses of EQ‐5D‐3L data showed no significant between‐group differences in quality of life over time . Conclusion These results confirm that the main findings of the PROFHER trial over two years are unchanged at five years OBJECTIVES To compare the outcomes of intramedullary fibular allograft ( IFA ) with locking compression plates ( LCPs ) versus shoulder hemi-arthroplasty ( HA ) in osteoporotic four-part proximal humeral fracture ( PHF ) . METHODS Between January 2010 and December 2012 , totally 60 cases with osteoporotic four-part PHF were enrolled in this study and were r and omly separated into IFA and LCPs group and HA group ( n=30 ) . Additionally , surgery indexes for patients in the two groups , such as Constant-Murley score ( CMS ) , the Disability of Arm , Shoulder and H and ( DASH ) score , individual subject evaluation of the outcomes , plain X-ray , and computer tomography ( CT ) scanning were evaluated and compared . RESULTS CMS , DASH score , activities of daily living ( ADL ) , and range of motion ( ROM ) were statistically higher in the IFA and LCPs group than those in the HA group at the last follow-up , whereas the pain were obviously lower than that in the HA group . Besides , patients in the IFA and LCPs group had higher abduction , external rotation with elbow , strength , and satisfactory rating compared with HA group at the last follow-up . However , one case developed avascular necrosis ( AVN ) , one case encountered screw perforation , and one case experienced varus displacement in the IFA and LCPs group , while there were 2 , 4 , and 2 cases suffered from superficial infection , shoulder stiffness , tuberosity migration in the HA group , respectively . CONCLUSION IFA with LCP have an advantage in functional outcomes than shoulder HA . LEVEL OF EVIDENCE Level II . Prospect i ve cohort study Abstract Background Surgical treatment for displaced proximal humeral fractures is widely used . However , there are very few r and omized controlled studies comparing surgical treatment to conservative treatment , and the evidence is debated . The aim of this study was to describe patients with displaced proximal humeral fractures in a 2-years extension of a r and omized controlled trial , their functional outcome and quality of life . Material s and methods Patients from a single-center r and omized controlled study of fifty patients aged 60 or above with displaced proximal humeral fracture ( AO/OTA group B2 or C2 ) were r and omized to surgical or conservative treatment . Surgery was performed with an angular stable implant . The main outcome was Constant score at 2-year follow-up . Secondary outcomes were an ASES self- assessment form , the 15D quality of life assessment and radiographs at 2 years . Results A marked improvement of shoulder function and health-related quality of life for both surgically and conservatively treated patients occurs between 6 and 12 months . Almost no change was observed between 1 and 2 year . There were no significant differences between the two treatments at 2-year follow-up . Conclusions In this r and omized controlled trial , surgical treatment proved no better results than conservative treatment for patients with displaced proximal humeral fracture at 2-year follow-up Purpose The purpose of this study was to evaluate the clinical benefit of medial support screws for locking plating of proximal humerus fractures . Methods Seventy-two consecutive patients underwent prospect i ve treatment for proximal humerus fractures with locking plates between October 2007 and September 2008 . Sixty-eight patients accomplished a mean 30.8-month follow-up and were r and omized into two groups : 39 patients were treated with only a locking plate and were classified in the –MSS ( medial support screw ) group , and 29 patients were included in the + MSS group , which were fixed with additional medial support screws . Clinical and radiological investigations were performed in both groups . Results The fractures united at an average of 13.6 weeks after final surgery . Comparably better shoulder function recovery was achieved in the + MSS group with regard to the Constant shoulder score ( P = 0.01 ) , with the respective excellent and good rates of 79 % and 62 % . Eleven patients developed various complications . A statistical difference ( P = 0.036 ) was observed regarding the failure rate ( 23.1 % in the −MSS group vs. 3.4 % in the + MSS group ) . The early loss of fixation was related to higher age ( P < 0.001 ) and less initial neck-shaft angle ( NSA ) ( P = 0.011 ) of the patients . However , bone mineral density was not significantly associated with loss of fixation ( P = 0.076 ) . Although no difference was found in all types of the fractures between the + MSS and −MSS groups regarding immediate postoperative NSA , we observed a significantly lower final NSA in the −MSS group and greater secondary angle loss in the subgroup of Neer three-part ( P = 0.033 and 0.015 , respectively ) and four-part fractures ( P = 0.043 and 0.027 ) . Conclusions Anatomical reduction can substantially decrease the risk of postoperative failure in locking plating of proximal humerus fractures . Medial support for proximal humerus fractures seems to have no benefits in Neer two-part fractures . However , the additional medial support screws inserted into the medio-inferior region of the humeral head may help to enhance mechanical stability in complex fractures and allow for better maintenance of reduction Abstract Background Fractures of the distal radius are extremely common injuries in adults . However , the optimal management remains controversial . In general , fractures of the distal radius are treated non-operatively if the bone fragments can be held in anatomical alignment by a plaster cast or orthotic . However , if this is not possible , then operative fixation is required . There are several operative options but the two most common in the UK , are Kirschner-wire fixation ( K-wires ) and volar plate fixation using fixed-angle screws ( locking-plates ) . The primary aim of this trial is to determine if there is a difference in the Patient-Reported Wrist Evaluation one year following K-wire fixation versus locking-plate fixation for adult patients with a dorsally-displaced fracture of the distal radius . Methods / design All adult patients with an acute , dorsally-displaced fracture of the distal radius , requiring operative fixation are potentially eligible to take part in this study . A total of 390 consenting patients will be r and omly allocated to either K-wire fixation or locking-plate fixation . The surgery will be performed in trauma units across the UK using the preferred technique of the treating surgeon . Data regarding wrist function , quality of life , complications and costs will be collected at six weeks and three , six and twelve months following the injury . The primary outcome measure will be wrist function with a parallel economic analysis . Discussion This pragmatic , multi-centre trial is due to deliver results in December 2013.Trial registration Current Controlled Trials IS RCT N31379280 UKCRN portfolio ID Fifty patients with complex distal radial fractures treated by primary external fixation were compared with 50 with similar fractures treated by closed medullary pinning . All the patients had Frykman type-VIII injuries . The two groups were similar in regard to demographic characteristics and the method of treatment was r and omly chosen . All the fractures healed within three months . In the external fixation
Output:
| The trend in Sweden is that surgical treatment of PHF is increasing .
Evidence was scarce regarding comparisons of different surgical options for humerus fracture treatment .
The cost of plate fixation of a PHF was at least USD 3900 higher than non-surgical treatment , costs for complications excluded .
There is moderate/low certainty of evidence that surgical treatment of moderately displaced PHF in elderly patients has not been proven to be superior to less costly non-surgical treatment options . |
MS213459 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND African Americans suffer disproportionately from diabetes complications , but little research has focused on how to improve diabetic control in this population . There are also few or no data on a combined primary care and community-based intervention approach . METHODS We r and omly assigned 186 urban African Americans with type 2 diabetes ( 76 % female , mean A SD age 59 A 9 years ) to 1 of 4 parallel arms : ( 1 ) usual care only ; ( 2 ) usual care + nurse case manager ( NCM ) ; ( 3 ) usual care + community health worker ( CHW ) ; ( 4 ) usual care + nurse case manager/community health worker team . Using the framework of the Precede-Proceed behavioral model , interventions included patient counseling regarding self-care practice s and physician reminders . RESULTS The 2-year follow-up visit was completed by 149 individuals ( 84 % ) . Compared to the Usual care group , the NCM group and the CHW group had modest declines in HbA(1c ) over 2 years ( 0.3 and 0.3 % , respectively ) , and the combined NCM/CHW group had a greater decline in HbA(1c ) ( 0.8 % . P = 0.137 ) . After adjustment for baseline differences and /or follow-up time , the combined NCM/CHW group showed improvements in triglycerides ( -35.5 mg/dl ; P = 0.041 ) and diastolic blood pressure , compared to the usual care group ( -5.6 mmHg ; P = 0.042 ) . CONCLUSIONS Combined NCM/CHW interventions may improve diabetic control in urban African Americans with type 2 diabetes . Although results were clinical ly important , they did not reach statistical significance . This approach deserves further attention as a means to reduce the excess risk of diabetic complications in African Americans Background : Lack of concordance between medications listed in the medical record and taken by the patient contributes to poor outcomes . We sought to determine whether patients who received health coaching by medical assistants improved their medication concordance and adherence . Methods : This was a nonblinded , r and omized , controlled , pragmatic intervention trial . English- or Spanish-speaking patients , age 18 to 75 years , with poorly controlled type 2 diabetes , hypertension , and /or hyperlipidemia were enrolled from 2 urban safety net clinics and r and omized to receive 12 months of health coaching versus usual care . Results : Outcomes included concordance between medications documented in the medical record and those reported by the patient and adherence based on the patient-reported number of days ( of the last 7 ) on which patient took all prescribed medications . The proportion of medications completely concordant increased in the coached group versus the usual care group ( difference in change , 10 % ; P = .05 ) . The proportion of medications listed in the chart but not taken significantly decreased in the coached group compared with the usual care group ( difference in change , 17 % ; P = .013 ) . The mean number of adherent days increased in the coached but not in the usual care group ( difference in change , 1.08 ; P < .001 ) . Conclusions : Health coaching by medical assistants significantly increases medication concordance and adherence Patient navigation ( PN ) programs are being widely implemented to reduce disparities in cancer care for racial/ethnic minorities and the poor . However , few systematic studies cogently describe the processes of PN . We qualitatively analyzed 21 transcripts of semistructured exit interviews with three navigators about their experiences with patients who completed a r and omized trial of PN . We iteratively discussed codes/categories , reflective remarks , and ways to focus/organize data and developed rules for summarizing data . We followed a three-stage analysis model : reduction , display , and conclusion drawing/verification . We used ATLAS.ti_5.2 for text segmentation , coding , and retrieval . Four categories of factors affecting cancer care outcomes emerged : patients , navigators , navigation processes , and external factors . These categories formed a preliminary conceptual framework describing ways in which PN processes influenced outcomes . Relationships between processes and outcomes were influenced by patient , navigator , and external factors . The process of PN has at its core relationship-building and instrumental assistance . An enhanced underst and ing of the process of PN derived from our analyses will facilitate improvement in navigators ’ training and rational design of new PN programs to reduce disparities in cancer-related care OBJECTIVE To assess the impact of health coaching on patients ' in their primary care provider . METHODS R and omized controlled trial comparing health coaching with usual care . PARTICIPANTS Low-income English or Spanish speaking patients age 18 - 75 with poorly controlled type 2 diabetes , hypertension and /or hyperlipidemia . MAIN OUTCOME MEASURE Patient trust in their primary care provider measured by the 11-item Trust in Physician Scale , converted to a 0 - 100 scale . ANALYSIS Linear mixed modeling . RESULTS A total of 441 patients were r and omized to receive 12 months of health coaching ( n=224 ) vs. usual care ( n=217 ) . At baseline , the two groups were similar to those in the usual care group with respect to demographic characteristics and levels of trust in their provider . After 12 months , the mean trust level had increased more in patients receiving health coaching ( 3.9 vs. 1.5 , p=0.47 ) , this difference remained significant after adjustment for number of visits to primary care providers ( adjusted p=.03 ) . CONCLUSIONS Health coaching appears to increase patients trust in their primary care providers . PRACTICE IMPLICATION S Primary care providers should consider adding health coaches to their team as a way to enhance their relationship with their patients Debates over the degree to which st and ards of evidence and methods from traditional clinical research can or should apply to quality improvement ( QI ) have recurred over the past 10 years.1–4 When , if ever , do we need a r and omised controlled trial ( RCT ) demonstrating benefit to decide that an intervention has worked ? Can we recommend QI interventions for widespread adoption even without supportive RCTs ? On one side of the debate , some have argued that QI and the RCT are like oil and water — never the twain shall mix . Certainly , many have argued , we should not presume that RCTs represent the gold st and ard for evidence in QI . On the face of it , the report by Mate et al 5 supports this oil and water view of RCTs and QI interventions . The authors report their struggles conducting a pragmatic , multisite RCT of a complex intervention to reduce perinatal transmission of HIV in KwaZulu-Natal Province , South Africa . The intervention included socioadaptive strategies,6 , 7 such as engaging local health system leaders , securing a commitment to the aims of the project , and providing participating health centres with the tools to perform data -driven improvement cycles . It also promoted specific best practice s for key steps in the prevention of perinatal transmission of HIV ( eg , increasing the proportion of women receiving early antenatal care that includes HIV counselling and testing , increasing the proportion of mothers with low CD4 counts who receive treatment , and so on ) . The authors initially planned to evaluate this complex intervention using an equally complex study design —a step-wedge , cluster RCT involving 48 clusters of clinics ( for a total of 222 individual clinics ) in three waves of intervention and control sites ; hence , the ‘ step-wedge ’ label . It will come as no surprise to most readers that this double dose of complexity — from the intervention itself and the trial design —overwhelmed OBJECTIVES We tested the effectiveness of a culturally tailored , behavioral theory-based community health worker intervention for improving glycemic control . METHODS We used a r and omized , 6-month delayed control group design among 164 African American and Latino adult participants recruited from 2 health systems in Detroit , Michigan . Our study was guided by the principles of community-based participatory research . Hemoglobin A1c ( HbA1c ) level was the primary outcome measure . Using an empowerment-based approach , community health workers provided participants with diabetes self-management education and regular home visits , and accompanied them to a clinic visit during the 6-month intervention period . RESULTS Participants in the intervention group had a mean HbA1c value of 8.6 % at baseline , which improved to a value of 7.8 % at 6 months , for an adjusted change of -0.8 percentage points ( P < .01 ) . There was no change in mean HbA1c among the control group ( 8.5 % ) . Intervention participants also had significantly greater improvements in self-reported diabetes underst and ing compared with the control group . CONCLUSIONS This study contributes to the growing evidence for the effectiveness of community health workers and their role in multidisciplinary teams engaged in culturally appropriate health care delivery Objectives . Although people with HIV experience significant oral health problems , many consistently identify oral health as an unmet health care need . We conducted a r and omized controlled trial to evaluate the impact of a dental case management intervention on dental care use . Methods . We evaluated the intervention according to self-reported dental care use at 6- , 12- , and 18-month follow-ups . Multivariable logistic models with generalized estimating equations were used to assess the effects of the intervention over time . Results . The odds of having a dental care visit were about twice as high in the intervention group as in the st and ard care group at 6 months ( adjusted odds ratio [ OR ] = 2.52 ; 95 % confidence interval [ CI ] = 1.58 , 4.08 ) and 12 months ( adjusted OR = 1.98 ; 95 % CI = 1.17 , 3.35 ) , but the odds were comparable in the 2 groups by 18 months ( adjusted OR = 1.07 ; 95 % CI = 0.62 , 1.86 ) . Factors significantly associated with having a dental care visit included frequent physician visits and dental care referrals . Conclusions . We demonstrated that a dental case management intervention targeting people with HIV was efficacious but not sustainable over time . Barriers not addressed in the intervention must be considered to sustain its use over time Background : There is limited high- quality evidence about the impact of patient navigation ( PN ) on outcomes for patients with diagnosed cancer . Methods : We pooled data from two sites from the national Patient Navigation Research Program . Patients ( n = 438 ) with newly diagnosed breast ( n = 353 ) or colorectal cancer ( n = 85 ) were r and omized to PN or usual care . Trained lay navigators met with patients r and omized to PN to help them assess treatment barriers and identify re sources to overcome barriers . We used intent-to-treat analysis to assess time to completion of primary treatment , psychologic distress ( impact of events scale ) , and satisfaction ( patient satisfaction with cancer-related care ) within 3 months after initiation of cancer treatment . Results : The sample was predominantly middle-aged ( mean age = 57 ) and female ( 90 % ) ; 44 % were race-ethnic minorities ( 44 % ) , 46 % reported lower education levels , 18 % were uninsured , and 9 % reported a non-English primary language . The r and omized groups were comparable in baseline characteristics . Primary analysis showed no statistically significant group differences in time to completion of primary cancer treatment , satisfaction with cancer-related care , or psychologic distress . Subgroup analysis showed that socially disadvantaged patients ( i.e. , uninsured , low English proficiency , and non-English primary language ) who received PN reported higher satisfaction than those receiving usual care ( all P < 0.05 ) . Navigated patients living alone reported greater distress than those receiving usual care . Conclusions : Although the primary analysis showed no overall benefit , the subgroup analysis suggests that PN may improve satisfaction with care for certain disadvantaged individuals . Impact : PN for cancer patients may not necessarily reduce treatment time nor distress . Cancer Epidemiol Biomarkers Prev ; 21(10 ) ; 1673–81 . © 2012 AACR BACKGROUND AND OBJECTIVES Many patients with ESRD , particularly minorities and women , face barriers in completing the steps required to obtain a transplant . These eight sequential steps are as follows : medical suitability , interest in transplant , referral to a transplant center , first visit to center , transplant workup , successful c and i date , waiting list or identify living donor , and receive transplant . This study sought to determine the effect of navigators on completion of steps . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS Cluster r and omized , controlled trial at 23 Ohio hemodialysis facilities . One hundred sixty-seven patients were recruited between January 2009 and August 2009 and were followed for up to 24 months or until study end in February 2011 . Trained kidney transplant recipients met monthly with intervention participants ( n=92 ) , determined their step in the transplant process , and provided tailored information and assistance in completing the step . Control participants ( n=75 ) continued to receive usual care . The primary outcome was the number of transplant process steps completed . RESULTS Starting step did not significantly differ between the two groups . By the end of the trial , intervention participants completed more than twice as many steps as control participants ( 3.5 versus 1.6 steps ; difference , 1.9 steps ; 95 % confidence interval , 1.3 - 2.5 steps ) . The effect of the intervention on step completion was similar across race and sex subgroups . CONCLUSIONS Use of trained transplant recipients as navigators result ed in increased completion of transplant process steps BACKGROUND A r and omized , controlled trial was conducted to evaluate the impact of a directly administered antiretroviral therapy program ( DAART ) and intensive adherence case management ( IACM ) intervention on virologic and immunologic response to highly active antiretroviral therapy ( HAART ) among patients
Output:
| Conclusions There is considerable heterogeneity in intervention content across patient navigator interventions .
Our results provide a schema from which to develop PN interventions and illustrate how an evidence -based model was used to develop a real-world PN intervention . |
MS213460 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background / Aims Patients with chronic obstructive pulmonary disease ( COPD ) experience more problematic respiratory symptoms and have more trouble performing daily activities in the morning . The aim of this study was to assess the perception of COPD symptoms related to morning activities in patients with severe airflow limitation . Methods Data of 133 patients with severe airflow limitation were analyzed in a prospect i ve , non-interventional study . A clinical symptom question naire was completed by patients at baseline . In patients having morning symptoms , defined by at least one or more prominent or aggravating symptom during morning activities , a morning activity question naire was also completed at baseline and following 2 months of COPD treatment . Results The most frequently reported COPD symptom was breathlessness ( 90.8 % ) . Morning symptoms were reported in 76 ( 57 % ) patients ; these had more frequent and severe clinical COPD symptoms . The most frequently reported morning activity was getting out of bed ( 82.9 % ) . The long acting muscarinic antagonist ( odds ratio [ OR ] , 6.971 ; 95 % confidence interval [ CI ] , 1.317 to 11.905 ) and chest tightness ( OR , 0.075 ; 95 % CI , 0.011 to 0.518 ) were identified as significantly related to absence of morning symptoms . There was no significant correlation between the degree of forced expiratory volume in 1 second improvement and severity score differences of all items of morning activity after 2-month treatment . Conclusions Fifty-seven percent of COPD patients with severe airflow limitation have morning symptoms that limit their morning activities . These patients also have more prevalent and severe COPD symptoms . The results of this study therefore provide valuable information for the development of patient-reported outcomes in COPD Background The combination of aclidinium bromide , a long-acting anticholinergic , and formoterol fumarate , a long-acting beta2-agonist ( 400/12 μg twice daily ) achieves improvements in lung function greater than either monotherapy in patients with chronic obstructive pulmonary disease ( COPD ) , and is approved in the European Union as a maintenance treatment . The effect of this combination on symptoms of COPD and exacerbations is less well established . We examined these outcomes in a pre-specified analysis of pooled data from two 24-week , double-blind , parallel-group , active- and placebo-controlled , multicentre , r and omised Phase III studies ( ACLIFORM and AUGMENT ) . Methods Patients ≥40 years with moderate to severe COPD ( post-bronchodilator forced expiratory volume in 1 s [FEV1]/forced vital capacity < 70 % and FEV1 ≥30 % but < 80 % predicted normal ) were r and omised ( ACLIFORM : 2:2:2:2:1 ; AUGMENT : 1:1:1:1:1 ) to twice-daily aclidinium/formoterol 400/12 μg or 400/6 μg , aclidinium 400 μg , formoterol 12 μg or placebo via Genuair ™ /Pressair ® . Dyspnoea ( Transition Dyspnoea Index ; TDI ) , daily symptoms ( EXAcerbations of Chronic pulmonary disease Tool [EXACT]-Respiratory Symptoms [ E-RS ] question naire ) , night-time and early-morning symptoms , exacerbations ( Healthcare Re source Utilisation [ HCRU ] and EXACT definitions ) and relief-medication use were assessed . Results The pooled intent-to-treat population included 3394 patients . Aclidinium/formoterol 400/12 μg significantly improved TDI focal score versus placebo and both monotherapies at Week 24 ( all p < 0.05 ) . Over 24 weeks , significant improvements in E-RS total score , overall night-time and early-morning symptom severity and limitation of early-morning activities were observed with aclidinium/formoterol 400/12 μg versus placebo and both monotherapies ( all p < 0.05 ) . The rate of moderate or severe HCRU exacerbations was significantly reduced with aclidinium/formoterol 400/12 μg compared with placebo ( p < 0.05 ) but not monotherapies ; the rate of EXACT-defined exacerbations was significantly reduced with aclidinium/formoterol 400/12 μg versus placebo ( p < 0.01 ) and aclidinium ( p < 0.05 ) . Time to first HCRU or EXACT exacerbation was longer with aclidinium/formoterol 400/12 μg compared with placebo ( all p < 0.05 ) but not the monotherapies . Relief-medication use was reduced with aclidinium/formoterol 400/12 μg versus placebo and aclidinium ( p < 0.01 ) . Conclusions Aclidinium/formoterol 400/12 μg significantly improves 24-hour symptom control compared with placebo , aclidinium and formoterol in patients with moderate to severe COPD . Furthermore , aclidinium/formoterol 400/12 μg reduces the frequency of exacerbations compared with placebo . Trial registration NCT01462942 and NCT01437397 ( Clinical Trials.gov UNLABELLED Indacaterol is a novel , inhaled , long-acting β(2)-agonist providing 24-h bronchodilation with once-daily ( o.d . ) dosing in patients with COPD . In this double-blind , incomplete block crossover study , patients with moderate-to-severe COPD were r and omised to receive three treatment cycles from : indacaterol 300 μg o.d . dosed PM or AM , salmeterol 50 μg twice daily or placebo , each for 14 days . Trough FEV(1 ) was measured 24 h after indacaterol , and 12 h after salmeterol . Ninety-six patients ( mean age : 64 years ; post-bronchodilator FEV(1 ) 57 % predicted , FEV(1)/FVC 55 % ) were r and omised ; 83 completed . After 14 days , the difference vs. placebo in trough FEV(1 ) for PM indacaterol was 200 mL ( p < 0.001 [ primary analysis ] ) and for AM indacaterol was 200 mL ( p < 0.001 ) . Compared with salmeterol , trough FEV(1 ) for PM indacaterol was 110 mL higher ( p < 0.001 ) , and for AM indacaterol was 50 mL higher ( p = NS ) . Over 14 days , vs. placebo , both PM and AM indacaterol improved the % of nights with no awakenings ( by 11.9 and 8.1 points ; p < 0.01 ) ; the % of days with no daytime symptoms ( by 6.7 and 5.5 points ; p < 0.05 ) ; and the % of days able to perform usual activities ( by 6.7 and 7.8 points ; p < 0.05 ) . Indacaterol provided 24-h bronchodilation and improvement in symptoms regardless of whether taken regularly in the morning or evening . CLINICAL TRIAL REGISTRATION Clinical Trials.gov NCT00615030 Abstract Background : This Phase III study evaluated the efficacy and safety of twice-daily aclidinium 200 μg and 400 μg versus placebo in the treatment of moderate-to-severe COPD . Methods : In this 12-week , double-blind , multicenter trial , patients were r and omized ( 1:1:1 ) to inhaled twice-daily aclidinium 200 μg , aclidinium 400 μg , or placebo . Primary and secondary endpoints were changes from baseline in trough FEV1 and peak FEV1 at Week 12 , respectively . Health status ( St. George 's Respiratory Question naire [ SGRQ ] ) , COPD symptoms ( Transitional Dyspnea Index [ TDI ] , night and early morning symptoms ) , and safety were also assessed . Results : A total of 561 patients ( mean age , 64 ± 9 years ) with a mean baseline FEV1 of 1.36 ± 0.54 L ( 47.2 % of predicted value ) were r and omized . At Week 12 , aclidinium 200 μg and 400 μg showed significant improvements from baseline in mean ( 95 % CI ) trough FEV1 compared with placebo by 86 ( 45 , 127 ) mL and 124 ( 83,164 ) mL , respectively , and in peak FEV1 by 146 ( 101 , 190 ) mL and 192 ( 148 , 236 ) mL , respectively ( p ≤ 0.0001 for all ) . Both aclidinium doses also provided significant improvements in SGRQ , TDI and almost all COPD symptom scores compared with placebo ( p < 0.05 for all ) . Incidences of adverse events ( AEs ) were similar across treatment groups . The incidence of anticholinergic AEs was low and similar across groups ( dry mouth : 0.5%–1.6 % ; constipation : 0%-1.1 % ) . Conclusions : Treatment of moderate-to-severe COPD patients with twice-daily aclidinium 200 μg and 400 μg was associated with significant improvements in bronchodilation , health status , and COPD symptoms . Both doses were well tolerated and had safety profiles similar to placebo . Trial Registration : This ACCORD I study ( AClidinium in Chronic Obstructive Respiratory Disease I ) was registered on clinical trials.gov ( NCT00891462 ) as “ Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease ( COPD ) ” Background Symptoms , particularly dyspnea , and activity limitation , have an impact on the health status and the ability to function normally in patients with chronic obstructive pulmonary disease ( COPD ) . Methods To develop an electronic patient diary ( eDiary ) , qualitative patient interviews were conducted from 2009 to 2010 to identify relevant symptoms and degree of bother due to symptoms . The eDiary was completed by a subset of 209 patients with moderate-to-severe COPD in the 26-week QVA149 SHINE study . Two morning assessment s ( since awakening and since the last assessment ) and one evening assessment were made each day . Assessment s covered five symptoms ( “ shortness of breath , ” “ phlegm/mucus , ” “ chest tightness , ” “ wheezing , ” and “ coughing ” ) and two impact items ( “ bothered by COPD ” and “ difficulty with activities ” ) and were scored on a 10-point numeric scale . Results Patient compliance with the eDiary was 90.4 % at baseline and 81.3 % at week 26 . Correlations between shortness of breath and impact items were > 0.95 . Regression analysis showed that shortness of breath was a highly significant ( P<0.0001 ) predictor of impact items . Exploratory factor analysis gave a single factor comprising all eDiary items , including both symptoms and impact items . Shortness of breath , the total score ( including five symptoms and two impact items ) , and the five-item symptom score from the eDiary performed well , with good consistency and reliability . The eDiary showed good sensitivity to change , with a 0.6 points reduction in the symptoms scores ( on a 0–10 point scale ) representing a meaningful change . Conclusion The eDiary was found to be valid , reliable , and responsive . The high correlations obtained between “ shortness of breath ” and the ratings of “ bother ” and “ difficulty with activities ” confirmed the relevance of this symptom in patients with COPD . Future studies will be required to explore further psychometric properties and their ability to differentiate between COPD treatments Background A previous Phase IIIb study ( NCT01462929 ) in patients with moderate to severe COPD demonstrated that 6 weeks of treatment with aclidinium led to improvements in 24-hour bronchodilation comparable to those with tiotropium , and improvement of symptoms versus placebo . This post hoc analysis was performed to assess the effect of treatment in the symptomatic patient group participating in the study . Methods Symptomatic patients ( defined as those with Evaluating Respiratory Symptoms [ E-RS ™ ] in COPD baseline score ≥10 units ) received aclidinium bromide 400 μg twice daily ( BID ) , tiotropium 18 μg once daily ( QD ) , or placebo , for 6 weeks . Lung function , COPD respiratory symptoms , and incidence of adverse events ( AEs ) were assessed . Results In all , 277 symptomatic patients were included in this post hoc analysis . Aclidinium and tiotropium treatment improved forced expiratory volume in 1 second ( FEV1 ) from baseline to week 6 at all time points over 24 hours versus placebo . In addition , improvements in FEV1 from baseline during the nighttime period were observed for aclidinium versus tiotropium on day 1 ( aclidinium 157 mL , tiotropium 67 mL ; P<0.001 ) and week
Output:
| The accumulated evidence indicated that the symptomatic burden of COPD appears greatest in the morning , particularly upon waking , and that these morning symptoms have a substantial impact on patients ’ ability to function normally through the day ; they also worsen quality of life .
The literature also confirmed the importance of pharmacotherapy in the management of daytime COPD symptoms , and in helping normalize daily functioning . |
MS213461 | ***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 study the effect of a computerized medical record and other practice factors on the delivery of preventive health care . DESIGN Prospect i ve , controlled trial . SETTING University general internal medicine teaching clinic . PARTICIPANTS Forty-five internal medicine residents and their 4 supervising attending physicians . INTERVENTION The study group used a computerized ambulatory medical record system that included health care maintenance reminders . The control group used a conventional paper record with a health care maintenance flow sheet . MEASUREMENTS AND MAIN RESULTS The computer reminders significantly increased health care maintenance recommendations made to patients for proctosigmoidoscopy , tetanus vaccination , influenza vaccination , and pneumococcal vaccination , but not for fecal occult blood testing , mammography , Pap smears , or serum thyroxine screening in the elderly . First-year residents were nearly twice as successful as third-year residents in overall health care maintenance . Success scores varied markedly depending on which attending physician was supervising the residents . We found a strong interaction among group assignment , supervising attending , and level of training such that the reminders doubled success scores among first-year residents supervised by two of the attending physicians but had little effect on other subgroups . The time of year and the format of the reminder also had important effects for some of the maneuvers . CONCLUSIONS Although computerized medical records markedly improved the performance of prevention maneuvers by committed physicians , many physicians using computer systems failed to make use of the re source . The reasons for this were complex . Future work in this area should carefully control for personal behaviors and focus upon administrative changes that more effectively implement these potentially powerful tools 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 Adverse drug-related events are common in the elderly , and inappropriate prescribing is a preventable risk factor . Our objective was to determine whether inappropriate prescribing could be reduced when primary care physicians had computer-based access to information on all prescriptions dispensed and automated alerts for potential prescribing problems . METHODS We r and omly assigned 107 primary care physicians with at least 100 patients aged 66 years and older ( total 12 560 ) to a group receiving computerized decision-making support ( CDS ) or a control group . Physicians in the CDS group had access to information on current and past prescriptions through a dedicated computer link to the provincial seniors ' drug-insurance program . When any of 159 clinical ly relevant prescribing problems were identified by the CDS software , the physician received an alert that identified the nature of the problem , possible consequences and alternative therapy . The rate of initiation and discontinuation of potentially inappropriate prescriptions was assessed over a 13-month period . RESULTS In the 2 months before the study , 31.8 % of the patients in the CDS group and 33.3 % of those in the control group had at least 1 potentially inappropriate prescription . During the study the number of new potentially inappropriate prescriptions per 1000 visits was significantly lower ( 18 % ) in the CDS group than in the control group ( relative rate [ RR ] 0.82 , 95 % confidence interval [ CI ] 0.69 - 0.98 ) , but differences between the groups in the rate of discontinuation of potentially inappropriate prescriptions were significant only for therapeutic duplication by the study physician and another physician ( RR 1.66 , 95 % CI 0.99 - 2.79 ) and drug interactions caused by prescriptions written by the study physician ( RR 2.15 , 95 % CI 0.98 - 4.70 ) . INTERPRETATION Computer-based access to complete drug profiles and alerts about potential prescribing problems reduces the rate of initiation of potentially inappropriate prescriptions but has a more selective effect on the discontinuation of such prescriptions OBJECTIVE Computerized physician order entry with clinical decision support has been shown to improve medication safety in adult in patients , but few data are available regarding its usefulness in the long-term care setting . The objective of this study was to examine opportunities for improving medication safety in that clinical setting by determining the proportion of medication orders that would generate a warning message to the prescriber via a computerized clinical decision support system and assessing the extent to which these alerts would affect prescribers ' actions . DESIGN The study was set within a r and omized controlled trial of computerized clinical decision support conducted in the long-stay units of a large , academically-affiliated long-term care facility . In March 2002 , a computer-based clinical decision support system ( CDSS ) was added to an existing computerized physician order entry ( CPOE ) system . Over a subsequent one-year study period , prescribers ordering drugs for residents on three resident-care units of the facility were presented with alerts ; these alerts were not displayed to prescribers in the four control units . MEASUREMENTS We assessed the frequency of drug orders associated with various categories of alerts across all participating units of the facility . To assess the impact of actually receiving an alert on prescriber behavior during drug ordering , we calculated separately for the intervention and control units the proportion of the alerts , within each category , that were followed by an appropriate action and estimated the relative risk of an appropriate action in the intervention units compared to the control units . RESULTS During the 12 months of the study , there were 445 residents on the participating units of the facility , contributing 3,726 resident-months of observation time . During this period , 47,997 medication orders were entered through the CPOE system-approximately 9 medication orders per resident per month . 9,414 alerts were triggered ( 2.5 alerts per resident-month ) . The alert categories most often triggered were related to risks of central nervous system side-effects such as over-sedation ( 20 % ) . Alerts for risk of drug-associated constipation ( 13 % ) or renal insufficiency/electrolyte imbalance ( 12 % ) were also common . Twelve percent of the alerts were related to orders for warfarin . Overall , prescribers who received alerts were only slightly more likely to take an appropriate action ( relative risk 1.11 , 95 % confidence interval 1.00 , 1.22 ) . Alerts related to orders for warfarin or central nervous system side effects were most likely to engender an appropriate action , such as ordering a recommended laboratory test or canceling an ordered drug . CONCLUSION Long-term care facilities must implement new system-level approaches with the potential to improve medication safety for their residents . The number of medication orders that triggered a warning message in this study suggests that CPOE with a clinical decision support system may represent one such tool . However , the relatively low rate of response to these alerts suggests that further refinements to such systems are required , and that their impact on medication errors and adverse drug events must be carefully assessed 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 OBJECTIVE Interruptive alerts within electronic applications can cause " alert fatigue " if they fire too frequently or are clinical ly reasonable only some of the time . We assessed the impact of non-interruptive , real-time medication laboratory alerts on provider lab test ordering . DESIGN We enrolled 22 outpatient practice s into a prospect i ve , r and omized , controlled trial . Clinics either used the existing system or received on-screen recommendations for baseline laboratory tests when prescribing new medications . Since the warnings were non-interruptive , providers did not have to act upon or acknowledge the notification to complete a medication request . MEASUREMENTS Data were collected each time providers performed suggested laboratory testing within 14 days of a new prescription order . Findings were adjusted for patient and provider characteristics as well as patient clustering within clinics . RESULTS Among 12 clinics with 191 providers in the control group and 10 clinics with 175 providers in the intervention group , there were 3673 total events where baseline lab tests would have been advised : 1988 events in the control group and 1685 in the intervention group . In the control group , baseline labs were requested for 771 ( 39 % ) of the medications . In the intervention group , baseline labs were ordered by clinicians in 689 ( 41 % ) of the cases . Overall , no significant association existed between the intervention and the rate of ordering appropriate baseline laboratory tests . CONCLUSION We found that non-interruptive medication laboratory monitoring alerts were not effective in improving receipt of recommended baseline laboratory test monitoring for medications . Further work is necessary to optimize compliance with non-critical recommendations Advance directives name a surrogate decision maker or provide written instructions with the intent of extending patient autonomy with respect to end-of-life decisions [ 1 - 3 ] . Supported on various grounds by the public [ 1 ] , physicians [ 4 ] , ethicists [ 5 ] , and legislators [ 6 ] , advance directives have also been promoted as a way to control the high costs of health care at the end of life [ 7 , 8 ] . Most patients are interested in establishing advance directives , but few actually complete them [ 1 , 9 , 10 ] . In 1990 , the U.S. Congress passed the Patient Self-Determination Act , which requires hospitals to inform admitted patients about their right to record advance directives [ 6 , 11 ] . The Act does not dictate who should initiate these discussion s ( patients , physicians , or an admissions officer , for example ) [ 12 , 13 ] . It is therefore not surprising that the Act has had little effect on the rate of completion of advance directives [ 11 , 13 - 15 ] . Because hospitalized patients are often acutely ill and lose their ability to make decisions [ 3 ] , it may be more appropriate to discuss such issues before hospitalization [ 12 , 16 , 17 ] . Other interventions aim ed at increasing the establishment of advance directives have met with mixed success [ 18 ] . With one exception [ 19 ] , patient education has had little or no effect [ 20 - 24 ] . More effective interventions have trained physicians , social workers , or counselors to discuss advance directives [ 18 , 22 , 25 - 27 ] ; this has led to the conclusion that counseling by a clinician is the best catalyst for the completion of advance directives [ 28 ] . However , little is known about how to educate and motivate clinicians to solicit advance directives [ 28 ] . We [ 29 - 31 ] and others [ 32 ] have previously shown that computer reminders increase physician compliance with practice guidelines . In this study , we tested the hypothesis that reminding primary care physicians to discuss advance directives would stimulate such discussion s and lead to the establishment of more advance directives . Methods Setting and Patients This study was approved by the institutional review board of Indiana University as expedited research with waiver of informed consent from both patients and physicians . It was conducted in the General Medicine Practice [ 31 ] , an academic primary care practice affiliated with an urban public teaching hospital . This practice is staffed by general internal medicine faculty , fellows , and residents . Each resident and fellow attends the General Medicine Practice one half-day per week ; faculty attend one to four half-days per week . Residents always practice with the same attending faculty physicians . All physicians , except for study investigators , were eligible to participate . At the time of this study , the General Medicine Practice comprised four separate practice s with separate waiting areas ,
Output:
| AND IMPLICATION S OF KEY FINDINGS The analysis suggests a moderate effect of electronically generated , individually tailored reminders on clinician behaviour during the clinical encounter . |
MS213462 | ***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: Introduction Calretinin and Wilms ’ tumor gene ( WT1 ) are mesothelial markers routinely used to confirm the diagnosis of malignant pleural mesothelioma ( MPM ) . We investigated the prognostic value of calretinin and WT1 expression in predicting survival in a series of patients diagnosed with MPM in our institution . Material s and methods Fifty-two patients diagnosed of MPM were retrospectively review ed . Calretinin and WT1 were stained for IHC analysis in formalin-fixed , paraffin-embedded sections and positivity was considered for tumors with > 1 % of tumor cells stained . Survival data were calculated by the Kaplan – Meier method and Cox regression was used to evaluate the prognostic value of the variables . Results Calretinin IHC expression was positive in 83.7 % of patients and WT1 in 78.1 % . A significant association of calretinin and WT1 expression with epithelial histology was detected ( p = 0.030 and p = 0.010 ) . We found a significant increase in OS in patients with epithelial subtype , PS1 and neutrophil – lymphocyte ratio ( NLR ) ≤5 ( p < 0.05 ) . In the IHC markers analysis , we found a significant increase in OS for patients with WT1 positive expression ( 16.4 vs. 2.3 m , p = 0.013 ) , but not differences for calretinin expression ( 16.6 vs. 5.0 months , p = 0.37 ) . In the multivariate analysis , epithelial histology and WT1 remained as significant prognostic factors for survival ( p = 0.004 and p = 0.010 , respectively ) . Conclusion In our series of 52 MPM patients , epithelial histology , PS , NLR and WT1 expression are significant prognostic factors for survival . We concluded that WT1 , but not calretinin , is a useful prognostic factor in MPM . The role of WT1 assessment is worth of prospect i ve validation in future studies on MPM Purpose : We performed a phase I trial to investigate the safety , clinical responses , and Wilms ' tumor 1 (WT1)-specific immune responses following treatment with dendritic cells ( DC ) pulsed with a mixture of three types of WT1 peptides , including both MHC class I and II – restricted epitopes , in combination with chemotherapy . Experimental Design : Ten stage IV patients with pancreatic ductal adenocarcinoma ( PDA ) and 1 patient with intrahepatic cholangiocarcinoma ( ICC ) who were HLA-positive for A*02:01 , A*02:06 , A*24:02 , DRB1 * 04:05 , DRB1 * 08:03 , DRB1 * 15:01 , DRB1 * 15:02 , DPB1 * 05:01 , or DPB1 * 09:01 were enrolled . The patients received one course of gemcitabine followed by biweekly intradermal vaccinations with mature DCs pulsed with MHC class I ( DC/WT1-I ; 2 PDA and 1 ICC ) , II ( DC/WT1-II ; 1 PDA ) , or I/II – restricted WT1 peptides ( DC/WT1-I/II ; 7 PDA ) , and gemcitabine . Results : The combination therapy was well tolerated . WT1-specific IFNγ-producing CD4 + T cells were significantly increased following treatment with DC/WT1-I/II . WT1 peptide-specific delayed-type hypersensitivity ( DTH ) was detected in 4 of the 7 patients with PDA vaccinated with DC/WT1-I/II and in 0 of the 3 patients with PDA vaccinated with DC/WT1-I or DC/WT1-II . The WT1-specific DTH-positive patients showed significantly improved overall survival ( OS ) and progression-free survival ( PFS ) compared with the negative control patients . In particular , all 3 patients with PDA with strong DTH reactions had a median OS of 717 days . Conclusions : The activation of WT1-specific immune responses by DC/WT1-I/II combined with chemotherapy may be associated with disease stability in advanced pancreatic cancer . Clin Cancer Res ; 20(16 ) ; 4228–39 . © 2014 AACR
Output:
| In summary , our study suggests that WT1 may be a potential marker to predict DFS/RFS/PFS in solid tumor patients . |
MS213463 | ***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: CONTEXT Rates of obesity and other childhood chronic conditions have increased over recent decades . Patterns of how conditions change over time have not been widely examined . OBJECTIVE To evaluate change in prevalence of obesity and other chronic conditions in US children , including incidence , remission , and prevalence . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve study using the National Longitudinal Survey of Youth-Child Cohort ( 1988 - 2006 ) of 3 nationally representative cohorts of children . Children were aged 2 through 8 years at the beginning of each study period , and cohorts were followed up for 6 years , from 1988 to 1994 ( cohort 1 , n = 2337 ) , 1994 to 2000 ( cohort 2 , n = 1759 ) , and 2000 to 2006 ( n = 905 ) . MAIN OUTCOME MEASURES Parent report of a child having a health condition that limited activities or schooling or required medicine , special equipment , or specialized health services and that lasted at least 12 months . Obesity was defined as a body mass index at or above the 95th percentile for age . Chronic conditions were grouped into 4 categories : obesity , asthma , other physical conditions , and behavior/learning problems . RESULTS The end- study prevalence of any chronic health condition was 12.8 % ( 95 % confidence interval [ CI ] , 11.2%-14.5 % ) for cohort 1 in 1994 , 25.1 % ( 95 % CI , 22.7%-27.6 % ) for cohort 2 in 2000 , and 26.6 % ( 95 % CI , 23.5%-29.9 % ) for cohort 3 in 2006 . There was substantial turnover in chronic conditions : 7.4 % ( 95 % CI , 6.5%-8.3 % ) of participants in all cohorts had a chronic condition at the beginning of the study that persisted to the end , 9.3 % ( 95 % CI , 8.3%-10.3 % ) reported conditions at the beginning that resolved within 6 years , and 13.4 % ( 95 % CI , 12.3%-14.6 % ) had new conditions that arose during the 6-year study period . The prevalence of having a chronic condition during any part of the 6-year study period was highest for cohort 3 ( 51.5 % ; 95 % CI , 47.3%-55.0 % ) , and there were higher rates among male ( adjusted odds ratio [ AOR ] , 1.24 ; 95 % CI , 1.07 - 1.42 ) , Hispanic ( AOR , 1.36 ; 95 % CI , 1.11 - 1.67 ) , and black ( AOR , 1.60 ; 95 % CI , 1.35 - 1.90 ) youth . CONCLUSIONS Prevalence of chronic conditions among children and youth increased from 1988 to 2006 . However , presence of these conditions was dynamic over each 6-year cohort OBJECTIVE To report initial feasibility and outcome from a pilot study of a new three-session intervention for caregivers of children newly diagnosed with cancer , Surviving Cancer Competently Intervention Program-Newly Diagnosed ( SCCIP-ND ) . METHOD Nineteen families ( 38 caregivers ) were r and omly assigned to SCCIP-ND or treatment as usual subsequent to learning of their child 's illness . The study design included pre- and 2-month postintervention assessment s , with state anxiety and posttraumatic stress symptoms as outcomes . Feasibility was based on therapist feedback and supervision , program evaluations , and data from study -tracking procedures . RESULTS SCCIP-ND appears to be an acceptable intervention that can be used successfully with caregivers over the first few months after diagnosis . Recruitment and retention data document feasibility but also highlight challenges . Preliminary outcome data show changes in the desired direction [ e.g. , reduced anxiety and parental posttraumatic stress symptoms ( PTSS ) ] . CONCLUSIONS The pilot data are supportive of the value and challenges of developing evidence -based family interventions in pediatric psychology Low-income African American children have disproportionately higher asthma morbidity and mortality . Education alone may not address barriers to asthma management due to psychosocial stress . This study evaluated the efficacy of a home-based family intervention integrating asthma education and strategies to address stress using a community-based participatory research model . Children age 8 to 13 with poorly controlled asthma and their caregivers were recruited from an urban hospital and an asthma camp . Caregivers with elevated scores on a stress measure were enrolled . Forty-three families were r and omized to the 4- to 6-session Home Based Family Intervention ( HBFI ) or the single session of Enhanced Treatment as Usual ( ETAU ) . All families received an asthma action plan and dust mite covers ; children performed spirometry and demonstrated MDI/spacer technique at each home visit . The HBFI addressed family-selected goals targeting asthma management and stressors . Asthma management , morbidity , family functioning , and caregiver stress were assessed at baseline , postintervention , and 6 months after the intervention . ED visits and hospitalizations were ascertained by medical record review for a year after intervention completion . Only one child ( 5 % ) in HBFI had an asthma-related hospitalization compared to 7 patients ( 35 % ) in ETAU in the year following intervention . Participants in both groups demonstrated improved asthma management and family functioning , and reduced ED visits , symptom days , missed school days , and caregiver stress , but there were no differential treatment effects . The results suggest that a home-based intervention addressing medical and psychosocial needs may prevent hospitalizations for children with poorly controlled asthma and caregivers under stress OBJECTIVE To compare glycemic control , body mass index ( BMI ) , neurocognitive function , and parenting stress for preschool-aged diabetic children r and omized to treatment either with continuous subcutaneous insulin infusion ( CSII ) or with intensive insulin injection therapy ( IIT ) . METHODS Children < 5 yr of age diagnosed with type 1 diabetes mellitus for at least 12 months were r and omized to either CSII ( n = 21 ) or IIT ( n = 21 ) for 6 months . After 6 months , the IIT group began CSII therapy and the CSII group continued on pumps . Hemoglobin A1c ( HbA1c ) and BMI percent were collected at baseline , 3 , 6 , 9 , and 12 months . Neurocognitive assessment s ( Developmental Test of Visual-Motor Integration and Stanford-Binet Intelligence Scale : Fourth Edition ) were administered to children , and parenting and child behavior assessment s ( Parenting Stress Index and Child Behavior Checklist ) were completed by parents and at baseline , 6 , and 12 months . RESULTS Thirty-five children completed the study . Mean HbA1c decreased significantly over the study period ( 8.9 % + /- 0.6 vs. 8.5 % + /- 0.7 , p = 0.006 ) . Initiation of CSII result ed in an HbA1c decrease of 0.4 % after 3 months ( p = 0.002 ) ; however , in the CSII first group , the HbA1c at 12 months was not significantly different from study start ( 8.8 % + /- 0.6 vs. 8.5 % + /- 0.6 ; p = 0.4 ) . There were no significant changes in BMI % , neurocognitive , parenting , and child behavior measures between groups . CONCLUSION Initiation of CSII vs. continuing IIT does not significantly influence HbA1c , BMI , neurocognitive , or parenting stress parameters in a research study setting Risk- and -resistance models identify factors that predict psychosocial adjustment to pediatric chronic illness , including sickle cell disease ( SCD ) , but have not been applied to underst and health outcomes . The study objectives were to examine prospect ively the relationship of coping and family functioning with health outcomes for adolescents with SCD , accounting for sociodemographic and psychosocial risk . Forty-one adolescents and their families ( 41 primary caregivers , 9 second caregivers , and 15 healthy siblings ) completed paper- and -pencil measures of coping and family functioning at a baseline assessment ( time 1 ) . At both time 1 and time 2 ( 1 y later ) , disease severity , SCD complications , healthcare utilization , and average hemoglobin level were derived from medical file review s. Time 1 disease-related parenting stress predicted time 2 health outcomes ; however , there were no significant associations for coping . Families concordant in reporting lower family functioning had teens with increased disease severity and greater healthcare utilization . Examination of moderation of disease-related parenting stress by a risk index showed main effects for risk and for disease-related parenting stress for time 2 disease severity and time 2 healthcare utilization . Interaction effects were not significant . Efforts to explore specific mechanisms by which adaptive family functioning contributes to health outcomes for adolescents with SCD should continue , with particular attention to addressing the potential role of multiple sociodemographic and psychosocial risk variables The ketogenic diet is increasingly used for the management of difficult-to-control seizures in children . Here , we describe the first prospect i ve study of the effects of the diet on development , behavior , and parenting stress . Participants were 65 children ( 36 males , 29 females ) with intractable seizures , ages 18 months to 14 years 6 months , enrolled in a prospect i ve study at the Johns Hopkins Hospital , Baltimore , MD , USA , to study the diet 's efficacy . Children were assessed before diet initiation and at 1-year follow-up . At follow-up , 52 % ( 34 of 65 ) children remained on the diet . Mean seizure frequency decreased from 25 per day before diet initiation to less than two per day 1 year later . At follow-up , mean developmental quotient showed statistically significant improvement ( p<0.05 ) , with significant behavioral improvements in attention and social functioning . Parental stress was essentially unchanged . No baseline factor examined predicted diet adherence , and the primary reason for diet discontinuation was insufficient seizure control . These preliminary results support prior anecdotal reports of the beneficial effects of the diet on cognition and behavior BACKGROUND Hypoglycemia in preschool children limits the effectiveness of insulin therapy . Continuous subcutaneous insulin infusion ( CSII ) is not widely used in this group . OBJECTIVES This study was design ed ( 1 ) to test the hypothesis that compared with twice-daily insulin injection , CSII decreases the SD of the mean daily blood glucose ( BG ) and improves glycemic control and ( 2 ) to evaluate the effect of CSII on parental anxiety using the Parental Stress Index ( PSI ) scale . METHODS Ten subjects < 6 years of age and receiving insulin injections were recruited . Each underwent two 72-h CGMS ( Medtronic Minimed , Northridge , CA ) monitoring periods and then was started on CSII and re-monitored 3 and 6 months later . We assessed the effects of CSII on the mean BG and SD of BG values , A1c , PSI scores , and number , distribution , and duration of hypoglycemic episodes . RESULTS Pooled pre- and post-CSII data were compared . There was a 22 % decrease in the BG variability ( mean + /- SD 93 + /- 19 mg/dL vs. 72 + /- 5 mg/dL ; P = 0.02 ) and a 13 % decrease in A1c ( 8.6 + /- 0.8 % vs. 7.5 + /- 0.7 % ; P = 0.01 ) . There was a decrease in the 24-h median number and duration of hypoglycemic episodes [ 1.16 vs. 0 episodes/24 h ( P = 0.01 ) and 1.19 vs. 0.05 h/24 h ( P = 0.01 ) , respectively ] , as well as the median number and duration of nighttime episodes [ 0.83 vs. 0 episode/night ( P = 0.008 ) and 0.98 vs. 0 h/night ( P = 0.008 ) , respectively ] . We found no statistically significant change in the PSI score . CONCLUSIONS CSII in preschool children is feasible and safe . Pump therapy reduced the glycemic excursions and decreased hypoglycemia duration and frequency In a prospect i ve study of 137 children ( 47 with cystic fibrosis , 48 with congenital heart disease , 42 with no chronic illness ) , four domains were examined as predictors of parent-reported behavioral problems , particularly internalizing problems , at 4 years of age : child health , child temperament , parent-child relationships , and family environment . Family environment , as measured by the Parenting Stress Index at 1 , 2 , and 3 years , was the most powerful predictor . This suggests that this index is useful as an early screen for children at risk for behavioral problems and that a reduction of parenting stress is an appropriate target of preventive interventions . J Dev Behav Pediatr 18:304 - 313 , 1997
Output:
| Qualitative analysis revealed that greater general parenting stress was associated with greater parental responsibility for treatment management and was unrelated to illness duration and severity across illness population s. Greater parenting stress was associated with poorer psychological adjustment in caregivers and children with chronic illness . |
MS213464 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Honey dressing has been used to promote wound healing for years but scanty scientific studies did not provide enough evidence s to justify it benefits in the treatment of diabetic foot ulcers . We conducted a prospect i ve study to compare the effect of honey dressing for Wagner 's grade -II diabetic foot ulcers with controlled dressing group ( povidone iodine followed by normal saline ) . Surgical debridement and appropriate antibiotics were prescribed in all patients . There were 30 patients age between 31 to 65-years-old ( mean of 52.1 years ) . The mean healing time in the st and ard dressing group was 15.4 days ( range 9 - 36 days ) compared to 14.4 days ( range 7 - 26 days ) in the honey group ( p < 0.005 ) . In conclusion , ulcer healing was not significantly different in both study groups . Honey dressing is a safe alternative dressing for Wagner grade -II diabetic foot ulcers : In recent years , skin grafting has evolved from the initial autograft and allograft preparations to biosynthetic and tissue-engineered living skin replacements . This review details the pioneering work of numerous investigators that led to the following precursors of tissue-engineered skin replacement : cultured autologous keratinocyte grafts , cultured allogeneic keratinocyte grafts , autologous/allogeneic composites , acellular collagen matrices , and cellular matrices . It also discusses the rationale for the development of the newer products and describes the technical advances leading to the development of Apligraf , a tissue-engineered human skin product OBJECTIVE To compare the efficacy and tolerability of a new ionic silver alginate matrix ( Askina Calgitrol Ag ) with that of a st and ard silver-free alginate dressing ( Algosteril ) . METHOD Patients with locally infected chronic wounds ( pressure ulcers , venous or mixed aetiology leg ulcers , diabetic foot ulcers ) or acute wounds were eligible for this prospect i ve , open-label , controlled and r and omised trial . Patients were r and omised to receive one of the two dressings for a two-week period . Criteria of efficacy were based on the evolution , from day 1 to day 15 , of local signs of infection using a clinical score ranging from 0 to 18 , and the evolution of the bacteriological status for each wound . The latter was determined by ( blind ) bacteriological examinations of results obtained from two biopsies performed at days 1 and 15 . A three-point scale ( deterioration , unchanged , improvement ) was also used . Acceptability , usefulness and tolerance were also assessed . RESULTS Forty-two patients ( 20 women and 22 men , 68.9 + /- 18.8 and 66.5 + /- 15.7 years old respectively ) were r and omly assigned to receive either Askina Calgitrol Ag ( n=20 ) or Algosteril ( n=22 ) . Most had chronic wounds such as pressure ulcers ( 57 % ) or venous or mixed aetiology leg ulcers and diabetic foot ulcers ( 29 % ) ; few had acute wounds ( 14 % ) . Clinical scores of infection were comparable in both groups at inclusion , 8.9 + /- 2.4 and 8.6 + /- 3.2 in the Askina Calgitrol Ag group and the Algosteril group respectively ( not significant ) , but decreased significantly in both groups at day 15 , 3.8 + /- 2.9 in the Askina Calgitrol Ag group ( p=0.001 ) and 3.8 + /- 3.4 in the Algosteril group ( p=0.007 ) . There was no significant difference between the two groups at day 15 . Although there was also no significant difference in bacteriological status between the treatment groups , a trend in favour of Askina Calgitrol Ag was found for the relative risk of improvement , especially in patients who were not treated with antibiotics either at the beginning of the study or during it . No differences between groups were observed regarding local tolerance , acceptability and usefulness of the dressings . CONCLUSION The regression of local signs of infection , local tolerance , acceptability and usefulness were similar for the two dressings . However , Askina Calgitrol Ag improved the bacteriological status of the wounds . Further trials are required to show that it has a positive impact on the healing process Summary The EURODIAB IDDM Complications Study involved the examination of 3250 r and omly selected insulin-dependent diabetic patients , from 31 centres in 16 European countries . Part of the examination included an assessment of neurological function including neuropathic symptoms and physical signs , vibration perception threshold , tests of autonomic function and the prevalence of impotence . The prevalence of diabetic neuropathy across Europe was 28 % with no significant geographical differences . Significant correlations were observed between the presence of diabetic peripheral neuropathy with age ( p < 0.05 ) , duration of diabetes ( p < 0.001 ) , quality of metabolic control ( p < 0.001 ) , height ( p < 0.01 ) , the presence of background or proliferative diabetic retinopathy ( p < 0.01 ) , cigarette smoking ( p < 0.001 ) , high-density lipoprotein cholesterol ( p < 0.001 ) and the presence of cardiovascular disease ( p < 0.05 ) , thus confirming previous associations . New associations have been identified from this study – namely with elevated diastolic blood pressure ( p < 0.05 ) , the presence of severe ketoacidosis ( p < 0.001 ) , an increase in the levels of fasting triglyceride ( p < 0.001 ) , and the presence of microalbuminuria ( p < 0.01 ) . All the data were adjusted for age , duration of diabetes and HbA1c . Although alcohol intake correlated with absence of leg reflexes and autonomic dysfunction , there was no overall association of alcohol consumption and neuropathy . The reported problems of impotence were extremely variable between centres , suggesting many cultural and attitudinal differences in the collection of such information in different European countries . In conclusion , this study has identified previously known and new potential risk factors for the development of diabetic peripheral neuropathy . [ Diabetologia ( 1996 ) 39 : 1377–1384 OBJECTIVE : A r and omized controlled trial to evaluate the effectiveness of a polyhexamethylene biguanide ( PHMB ) foam dressing compared with a similar non-antimicrobial foam for the treatment of superficial bacterial burden , wound-associated pain , and reduction in wound size . SETTING AND PARTICIPANTS : This study was conducted in 2 wound healing clinics-a university hospital-based clinic and a community-based clinic . Forty-five chronic wound subjects , stratified to either foot or leg ulcers , were followed for 5 weeks . METHODS : A multicenter , prospect i ve , double-blind , pilot , r and omized controlled clinical trial with 3 study visits ( Weeks 0 , 2 , 4 ) documented pain and local wound characteristics using NERDS and STONEES clinical criteria to determine superficial bacterial damage or deep/surrounding infection . RESULTS : The use of PHMB foam dressing was a significant predictor of reduced wound superficial bacterial burden ( P = .016 ) at week 4 as compared with the foam alone . Pain reduction was also statistically significant at week 2 ( P = .0006 ) and at week 4 ( P = .02 ) in favor of the PHMB foam dressings . Polymicrobial organisms were recovered at week 4 in 5.3 % in the PHMB foam dressing group versus 33 % in the control group ( P = .04 ) . Subjects r and omized to the PHMB foam dressing had a 35 % median reduction in wound size by week 4 , compared with 28 % in the control group . CONCLUSIONS : PHMB foam dressing successfully reduced chronic wound pain and bacterial burden OBJECTIVES To determine the comparative effectiveness and cost-effectiveness of three dressing products , N-A , Inadine and Aquacel , for patients with diabetic foot ulcers , as well as the feasibility and consequences of less frequent dressing changes by health-care professionals . DESIGN A multicentre , prospect i ve , observer-blinded , parallel group , r and omised controlled trial , with three arms . SETTING Established expert multidisciplinary clinics for the management of diabetic foot ulcers across the UK . PARTICIPANTS Patients over age 18 with type 1 or type 2 diabetes with a chronic ( present for at least 6 weeks ) full-thickness foot ulcer ( on or below the malleoli ) not penetrating to tendon , periosteum or bone , and with a cross-sectional area between 25 and 2500 mm(2 ) . INTERVENTIONS Participants were r and omised 1:1:1 to treatment with one of N-A ( a non-adherent , knitted , viscose filament gauze ) , Inadine ( an iodine-impregnated dressing ) , both traditional dressings , or Aquacel , a newer product . MAIN OUTCOME MEASURES The primary outcome measure was the number of ulcers healed in each group at week 24 . Secondary measures included time to healing , new ulcerations , major and minor amputations , and episodes of secondary infection . RESULTS A total of 317 patients were r and omised . After 88 withdrawals , 229 remained evaluable . A greater proportion of smaller ( 25 - 100 mm(2 ) ulcers healed within the specified time ( 48.3 % versus 37.3 % ; p = 0.048 ) . There was , however , no difference between the three dressings in terms of percentage healed by 24 weeks , or in the mean time to healing , whether analysed on the basis of intention to treat ( Inadine 44.4 % , N-A 38.7 % , Aquacel 44.7 % ; not significant ) or per protocol ( Inadine 55.2 % , N-A 59.4 % , Aquacel 63.0 % ; not significant ) . There was no difference in the quality of healing , as reflected in the incidence of recurrence within 12 weeks . Likewise , there was no difference in the incidence of adverse events , although a greater proportion of those r and omised to the non-adherent dressings were withdrawn from the study ( 34.9 % versus 29.1 % Aquacel and 19.4 % Inadine ; p = 0.038 ) . The only statistically significant difference found in the health economic analysis was the cost associated with the provision of dressings ( mean cost per patient : N-A 14.85 pounds , Inadine 17.48 pounds , Aquacel 43.60 pounds ) . The higher cost of Aquacel was not offset by the fewer dressings required . There was no difference in measures of either generic or condition-specific measures of quality of life . However , there was a significant difference in the change in pain associated with dressing changes between the first and second visits , with least pain reported by those receiving non-adherent dressings ( p = 0.012 ) . There was no difference in the costs of professional time , and this may relate to the number of dressing changes undertaken by non-professionals . Fifty-one per cent of all participants had at least one dressing change undertaken by themselves or a non-professional carer , although this ranged from 22 % to 82 % between the different centres . CONCLUSIONS As there was no difference in effectiveness , there is no reason why the least costly of the three dressings could not be used more widely across the UK National Health Service , thus generating potentially substantial savings . The option of involving patients and non-professional carers in changing dressings needs to be assessed more formally and could be associated with further significant reductions in health-care costs . TRIAL REGISTRATION Current Controlled Trials IS RCT N78366977 Nonhealing diabetic foot ulcers are a common cause of amputation . Emerging cellular therapies such as platelet-rich plasma gel provide ulcer management options to avoid loss of limb . The purpose of this prospect i ve , r and omized , controlled , blinded , multicenter clinical study was to evaluate the safety and efficacy of autologous platelet-rich plasma gel for the treatment of nonhealing diabetic foot ulcers . One hundred , twenty-nine ( 129 ) patients were screened ; 72 completed a 7-day screening period and met the study inclusion criteria . Patients were r and omized into two groups - the st and ard care with platelet-rich plasma gel or control ( saline gel ) dressing group - and evaluated biweekly for 12 weeks or until healing . Healing was confirmed 1 week following closure and monitored for another 11 weeks . An independent audit led to the exclusion of 32 patients from the final per- protocol analysis because of protocol violations and failure to complete treatment . In this group , 13 out of 19 ( 68.4 % ) of the platelet-rich plasma gel and nine out of 21 ( 42.9 % ) of the control wounds healed . After adjusting for wound size outliers ( n = 5 ) , significantly more platelet-rich plasma gel ( 13 out of 16 , 81.3 % ) than control gel ( eight out of 19 , 42.1 % ) treated wounds healed ( P = 0.036 , Fisher 's exact test ) . Kaplan-Meier time-to-healing also was significantly different between groups ( log-rank , P = 0.0177 ) . No treatment-related serious adverse events were reported and bovine thrombin used in the preparation of PRP did not
Output:
| Currently there is no research evidence to suggest that any type of hydrocolloid wound dressing is more effective in healing diabetic foot ulcers than other types of dressing or a topical cream containing plant extracts . |
MS213465 | ***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: Among a sample of 119 distressed high-utilizers of primary care , 45 % of patients evaluated by a psychiatrist as needing antidepressant treatment had been treated in the year before the examination . However , only 11 % of the patients needing antidepressants had received adequate dosage and duration of pharmacotherapy . In the year following the intervention , study patients whose physicians were advised regarding treatment during a psychiatric consultation were more likely to receive antidepressant medications ( 52.7 % ) relative to a r and omized control group ( 36.1 % ) . However , the intervention did not significantly increase the provision of adequate antidepressant therapy ( 37.1 % vs 27.9 % ) . Among study patients using antidepressants , patient characteristics did not differentiate patients who received adequate dosage and duration of antidepressant medications from those who did not . Analysis of data on the duration of antidepressant therapy for all health maintenance organization enrollees initiating use of antidepressants showed that only 20 % of patients who had been given prescriptions for first-generation antidepressants ( amitriptyline , imipramine , or doxepin ) filled four or more prescriptions in the following six months , compared to 34 % of patients who had prescriptions for newer antidepressants ( nortriptyline , desipramine , trazodone and fluoxetine ) . Experimental research evaluating whether these newer medications ( with more favorable side effect profiles ) improve adherence , and thereby patient outcome , is needed Background Evidence -based practice s design ed for large urban clinics are not necessarily portable into smaller isolated clinics . Implementing practice -based collaborative care for depression in smaller primary care clinics presents unique challenges because it is often not feasible to employ on-site psychiatrists . Objective The purpose of the Telemedicine Enhanced Antidepressant Management ( TEAM ) study was to evaluate a telemedicine-based collaborative care model adapted for small clinics without on-site psychiatrists . Design Matched sites were r and omized to the intervention or usual care . Participants Small VA Community-based outpatient clinics with no on-site psychiatrists , but access to telepsychiatrists . In 2003–2004 , 395 primary care patients with PHQ9 depression severity scores ≥12 were enrolled , and followed for 12 months . Patients with serious mental illness and current substance dependence were excluded . Measures Medication adherence , treatment response , remission , health status , health-related quality of life , and treatment satisfaction . Results The sample comprised mostly elderly , white , males with substantial physical and behavioral health comorbidity . At baseline , subjects had moderate depression severity ( Hopkins Symptom Checklist , SCL-20 = 1.8 ) , 3.7 prior depression episodes , and 67 % had received prior depression treatment . Multivariate analyses indicated that intervention patients were more likely to be adherent at both 6 ( odds ratio [ OR ] = 2.1 , p = .04 ) and 12 months ( OR = 2.7 , p = .01 ) . Intervention patients were more likely to respond by 6 months ( OR = 2.0 , p = .02 ) , and remit by 12 months ( OR = 2.4 , p = .02 ) . Intervention patients reported larger gains in mental health status and health-related quality of life , and reported higher satisfaction . Conclusions Collaborative care can be successfully adapted for primary care clinics without on-site psychiatrists using telemedicine technologies The object of the study was to evaluate outcomes of a r and omized clinical trial ( RCT ) of a pharmacist intervention for depressed patients in primary care ( PC ) . We report antidepressant ( AD ) use and depression severity outcomes at 6-months . The RCT was conducted between 1998 and 2000 in 9 eastern Massachusetts PC practice s. We studied 533 patients with major depression and /or dysthymia as determined by a screening test done at the time of a routine PC office visit . The majority of participants had recurrent depressive episodes ( 63.5 % with > /=4 lifetime episodes ) , and 49.5 % were taking AD medications at enrollment . Consultation in person and by telephone was performed by a clinical pharmacist who assisted the primary care practitioner ( PCP ) and patient in medication choice , dose , and regimen , in accordance with AHCPR depression guidelines . Six-month AD use rates for intervention patients exceeded controls ( 57.5 % vs. 46.2 % , P = .03 ) . Furthermore , the intervention was effective in improving AD use rates for patients not on ADs at enrollment ( 32.3 % vs. 10.9 % , P = .001 ) . The pharmacist intervention proved equally effective in subgroups traditionally considered difficult to treat : those with chronic depression and dysthymia . Patients taking ADs had better modified Beck Depression Inventory ( mBDI ) outcomes than patients not taking ADs , ( -6.3 points change , vs. -2.8 , P = .01 ) but the outcome differences between intervention and control patients were not statistically significant ( 17.7 BDI points vs. 19.4 BDI points , P = .16 ) . Pharmacists significantly improved rates of AD use in PC patients , especially for those not on ADs at enrollment , but outcome differences were too small to be statistically significant . Difficult-to-treat subgroups may benefit from pharmacists ' care Background : Depression is undertreated in primary care setting s. Little research investigates the impact of patient involvement in decisions on guideline -concordant treatment and depression outcomes . Objective : The objective of this study was to determine whether patient involvement in decision-making is associated with guideline -concordant care and improvement in depression symptoms . Design : Prospect i ve cohort study . Setting : Multisite , nationwide r and omized clinical trial of quality improvement strategies for depression in primary care . Subjects : Primary care patients with current symptoms and probable depressive disorder . Measurements : Patients rated their involvement in decision-making ( IDM ) about their care on a 5-point scale from poor to excellent 6 months after entry into the study . Depressive symptoms were measured every 6 months for 2 years using a modified version of theCenter for Epidemiologic Studies –Depression ( CES-D ) scale . We examined probabilities ( Pr ) of receipt of guideline -concordant care and resolution of depression across IDM groups using multivariate logistic regression models controlling for patient and provider factors . Results : For each 1-point increase in IDM ratings , the probability of patients ’ report of receiving guideline -concordant care increased 4 % to 5 % ( adjusted Pr 0.31 vs. 0.50 for the lowest and highest IDM ratings , respectively , P < 0.001 ) . Similarly , for each 1-point increase in IDM ratings , the probability of depression resolution increased 2 % to 3 % ( adjusted Pr 0.10 vs. 0.19 for the lowest and highest IDM ratings respectively , P = 0.004 ) . Conclusions : Depressed patients with higher ratings of involvement in medical decisions have a higher probability of receiving guideline -concordant care and improving their symptoms over an 18-month period . Interventions to increase patient involvement in decision-making may be an important means of improving care for and outcomes of depression OBJECTIVE This study evaluated the effectiveness of a structured telephone-based care management program for patients in a prepaid health plan receiving new antidepressant prescriptions from psychiatrists . METHODS Potential participants were identified with computerized medical records and contacted by telephone . Eligible and consenting participants were r and omly assigned to continued usual care ( N=104 ) or to a three-session telephone care management program ( N=103 ) . Care management contacts included assessment of depressive symptoms , medication adherence , and medication side effects with structured feedback to treating psychiatrists . Effectiveness was assessed three and six months after r and omization by blinded telephone assessment s ( depression scale on the Hopkins Symptom Checklist [ SCL ] and patient-rated global improvement ) . Computerized records were used to assess medication adherence and frequency of in-person follow-up visits . RESULTS Compared with usual care , the care management intervention had no significant effect on the mean score of the SCL depression scale at six months , on the probability of 50 percent improvement in depressive symptoms ( 41 percent for care management and 37 percent for usual care ) , or on the probability of patient-rated improvement ( 57 percent for care management and 52 percent for usual care ) . Patients assigned to care management made significantly more medication management visits over six months ( 2.4 visits compared with 2.0 visits ; p=.035 ) , but there were no significant differences in rates of adequate medication treatment . CONCLUSIONS This study found that a low-intensity telephone care management program did not appear to significantly improve clinical outcomes for patients starting antidepressant treatment . Compared with findings from earlier primary care studies , this study found that patients receiving care from a psychiatrist received more intensive treatment , although many still experienced poor outcomes Context Most successful disease management interventions for depression care have required intensive involvement of care managers or mental health specialists . Contribution The authors r and omly assigned 41 primary care physicians from 5 clinics to receive either depression decision support or usual care . Depression decision support was provided by a team that included a psychiatrist and a nurse care manager and involved an initial telephone contact , patient education , monthly record review , and sending a progress report to primary care physicians every 3 months . Depression severity improved equally in both groups over 12 months , despite evidence that intervention clinicians delivered more depression-related services . Implication s Decision support improved processes of depression care but not outcomes . The Editors Depression is a common problem worldwide . According to projections from the World Health Organization ( WHO ) , depression will be the second leading cause of disability in the developed world by 2020 ( 1 ) . One in 10 primary care patients meets criteria for major depression ( 2 ) , yet underrecognition and undertreatment are common ( 3 , 4 ) . Untreated depression is associated with increased deaths , adverse medical outcomes , deficits in function and well-being , and increased use of health services ( 3 , 59 ) . Multifaceted , collaborative interventions have been shown to improve depression-related outcomes in primary care ( 1022 ) . These interventions include decision support for clinicians , self-management support for patients , clinical information systems modifications , and care management . Care management typically consists of patient education and activation , symptom and treatment adherence monitoring , and self-management reinforcement ( 23 ) . Most collaborative depression interventions have relied on intensive involvement of care managers and specialists , usually shifting responsibility and workload toward mental health or research teams . Clinical systems may not be capable of sustaining this level of intensity . We therefore developed a multifaceted depression decision support intervention , which was design ed to optimize primary care clinicians ' abilities to treat depression without adding substantial new re sources . We aim ed to determine the effect of depression decision support on clinical outcomes and processes of care among patients with depression in a Veterans Affairs ( VA ) primary care setting . Methods Design Overview Our clinician-level , cluster r and omized , controlled trial studied depression decision support versus usual care . We r and omly assigned clinicians to either group and nested patients within clinician group assignment . We recruited participants between July 2002 and October 2003 from 5 primary care clinics of a VA medical center and followed patients for 12 months . The local institutional review board approved the study , and all patients and clinicians gave written informed consent . Setting Approximately 25000 veterans were treated during the study period in the 5 primary care clinics ( 3 urban and 2 rural clinics ) . Mental health clinicians are available on site in all clinics to provide consultation and brief treatment . A separate , more traditional mental health clinic serves approximately 8000 patients with chronic mental illnesses . Participants Full- and part-time staff physicians , fellows , physician assistants , and nurse practitioners were eligible to participate , and 41 ( 95 % ) of 43 eligible clinicians agreed to participate . To decrease variability in baseline depression-related knowledge and skills , we invited all clinicians to participate in the MacArthur Foundation depression education program ( 2427 ) before r and omization . In two 4-hour sessions , the program addresses communication skills and knowledge related to recognizing and managing depression . All patients of participating clinicians were eligible for the study . Research assistants review ed medical records of patients with upcoming primary care appointments ( within 4 to 6 weeks ) . They excluded patients who had received treatment from mental health specialists within the previous 6 months ; who had received a diagnosis of psychotic disorder , dementia , or bipolar disorder ; or who were considered to be terminally ill . They mailed study introduction letters to nonexcluded patients . The letters informed the patients that the research team would call them within 2 weeks unless they declined screening by notifying the study office . Telephone screening measures included the Patient Health Question naire ( PHQ-9 ) ( 28 ) and the Short Blessed Test screening for dementia ( 29 ) . We invited patients with PHQ-9 scores of 10 to 25 ( moderate to severe depression ) ( 30 ) to attend in-person enrollment interviews . We referred patients with PHQ-9 scores greater than 25 ( very severe depression ) or active dangerous ideation for urgent care , and we excluded them from participation . Enrollment interviews were scheduled within 2 weeks of primary care visits and usually took place the same day . The primary inclusion criterion was a repeated PHQ-9 score of 10 to 25 or a Hopkins Symptom Checklist-20 ( SCL-20 ) ( 31 ) score of 1.0 or greater at the enrollment interview . Of the 5434 patients
Output:
| The interventions which showed significant improvement in outcomes were primarily multifaceted and complex , with proactive care management and involvement of mental health specialists .
The most commonly used elements of multifaceted interventions included patient educational strategies , telephone follow-up to monitor patients ' progress , as well as providing medication support and feedback to primary care providers .
Overall , educational interventions alone were ineffective in improving antidepressant medication adherence .
In conclusion , improving adherence to antidepressants requires a complex behavioural change and there is some evidence to support behavioural and multifaceted interventions as the most effective in improving antidepressant medication adherence and depression outcomes . |
MS213466 | ***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 compared the effects of nefazodone , a serotonergic antidepressant , with the opioid antagonist naltrexone , and an inactive placebo in 183 alcohol-dependent subjects receiving weekly relapse prevention psychotherapy . Following a single-blind , placebo lead-in period , subjects were r and omly assigned to receive study medication , which they took under double-blind conditions for 11 weeks . Naltrexone treatment was associated with significantly more adverse neuropsychiatric and gastrointestinal effects , poorer compliance , and a greater rate of treatment attrition . There were no reliable between-group differences in drinking behavior . These results indicate that nefazodone is not efficacious for treatment of alcohol dependence . Furthermore , the clinical utility of naltrexone seems to be limited by its adverse effects , a finding that has important implication s for efforts to develop medications to treat alcohol dependence AIMS To determine the clinical ly ascertained variables that are related to satisfactory response to naltrexone ( NTX ) treatment of alcohol dependence after detoxification . METHODS The use of intake and outcome variables were measured in a r and omized 3-month open-controlled trial comparing the effects of naltrexone plus psychotherapy treatment versus psychotherapy treatment alone on the maintenance of abstinence in the final 28 days ( n = 336 , all male ) . RESULTS Predictors of a positive response to NTX treatment were family history of alcoholism ( P = 0.010 ) , early age at onset of drinking problems ( P = 0.014 ) and comorbid use of other drugs of abuse ( P < 0.001 ) . Among the subjects not treated with NTX , the greater the number of predictor variables , the lower the final 28 days abstinence rates ( P = 0.00003 ) , but this was not the case in patients treated with NTX ( P = 0.844 ) . CONCLUSIONS Patients with these features , suggesting biological vulnerability overall have poorer outcomes , but this can be reduced with NTX treatment . The type of alcoholism should be considered before deciding on the pharmacological strategy BACKGROUND Naltrexone ( NTX ) has proven to be effective with alcoholics in treatment , with most controlled clinical trials showing beneficial effects on heavy drinking rates . However , little is known about the behavioral mechanisms underlying the effects of NTX on drinking , or about patient characteristics that may moderate NTX 's effects on drinking . In this study , ecological momentary assessment ( EMA ) techniques were used to investigate some of the putative mechanisms of naltrexone 's effects on drinking in heavy drinkers who were not seeking treatment for alcohol problems . Polymorphisms in the D4 dopamine receptor ( DRD4 ) gene and the mu-opiate receptor ( OPRM1 ) gene , family history of alcohol problems , age of onset of alcoholism and gender were explored as potential moderators of NTX 's effects . METHODS After a 1-week placebo lead-in period , heavy drinkers ( n = 180 ) , 63 % of whom were alcohol-dependent , were r and omized to 3 weeks of daily naltrexone ( 50 mg ) or placebo . Throughout the study , participants used EMA on palm-pilot computers to enter , in real time , drink data , urge levels , and subjective effects of alcohol consumption . RESULTS Naltrexone reduced percentage drinking days in all participants and reduced percent heavy drinking days in DRD4-L individuals ; NTX decreased urge levels in participants with younger age of alcoholism onset ; NTX increased time between drinks in participants who had more relatives with alcohol problems ; and NTX reduced the stimulating effects of alcohol in women . OPRM1 status did not moderate any of NTX 's effects . CONCLUSIONS These results confirm earlier findings of NTX 's effects on drinking and related subjective effects , and extend them by describing individual difference variables that moderate these effects in the natural environment , using data collected in real time CONTEXT Alcohol dependence treatment may include medications , behavioral therapies , or both . It is unknown how combining these treatments may impact their effectiveness , especially in the context of primary care and other nonspecialty setting s. OBJECTIVES To evaluate the efficacy of medication , behavioral therapies , and their combinations for treatment of alcohol dependence and to evaluate placebo effect on overall outcome . DESIGN , SETTING , AND PARTICIPANTS R and omized controlled trial conducted January 2001-January 2004 among 1383 recently alcohol-abstinent volunteers ( median age , 44 years ) from 11 US academic sites with Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , diagnoses of primary alcohol dependence . INTERVENTIONS Eight groups of patients received medical management with 16 weeks of naltrexone ( 100 mg/d ) or acamprosate ( 3 g/d ) , both , and /or both placebos , with or without a combined behavioral intervention ( CBI ) . A ninth group received CBI only ( no pills ) . Patients were also evaluated for up to 1 year after treatment . MAIN OUTCOME MEASURES Percent days abstinent from alcohol and time to first heavy drinking day . RESULTS All groups showed substantial reduction in drinking . During treatment , patients receiving naltrexone plus medical management ( n = 302 ) , CBI plus medical management and placebos ( n = 305 ) , or both naltrexone and CBI plus medical management ( n = 309 ) had higher percent days abstinent ( 80.6 , 79.2 , and 77.1 , respectively ) than the 75.1 in those receiving placebos and medical management only ( n = 305 ) , a significant naltrexone x behavioral intervention interaction ( P = .009 ) . Naltrexone also reduced risk of a heavy drinking day ( hazard ratio , 0.72 ; 97.5 % CI , 0.53 - 0.98 ; P = .02 ) over time , most evident in those receiving medical management but not CBI . Acamprosate showed no significant effect on drinking vs placebo , either by itself or with any combination of naltrexone , CBI , or both . During treatment , those receiving CBI without pills or medical management ( n = 157 ) had lower percent days abstinent ( 66.6 ) than those receiving placebo plus medical management alone ( n = 153 ) or placebo plus medical management and CBI ( n = 156 ) ( 73.8 and 79.8 , respectively ; P<.001 ) . One year after treatment , these between-group effects were similar but no longer significant . CONCLUSIONS Patients receiving medical management with naltrexone , CBI , or both fared better on drinking outcomes , whereas acamprosate showed no evidence of efficacy , with or without CBI . No combination produced better efficacy than naltrexone or CBI alone in the presence of medical management . Placebo pills and meeting with a health care professional had a positive effect above that of CBI during treatment . Naltrexone with medical management could be delivered in health care setting s , thus serving alcohol-dependent patients who might otherwise not receive treatment . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00006206 BACKGROUND Access to specialty alcoholism treatment in rural environments is limited and new treatment approaches are needed . The objective was to evaluate the efficacy of naltrexone alone and in combination with sertraline among Alaska Natives and other Alaskans living in rural setting s. An exploratory aim examined whether the Asn40Asp polymorphism of the mu-opioid receptor gene ( OPRM1 ) predicted response to naltrexone , as had been reported in Caucasians . METHODS R and omized , controlled trial enrolling 101 Alaskans with alcohol dependence , including 68 American Indians/Alaska Natives . Participants received 16 weeks of either ( 1 ) placebo ( placebo naltrexone + placebo sertraline ) , ( 2 ) naltrexone monotherapy ( 50 mg naltrexone + sertraline placebo ) and ( 3 ) naltrexone + sertraline ( 100 mg ) plus nine sessions of medical management and supportive advice . Primary outcomes included Time to First Heavy Drinking Day and Total Abstinence . RESULTS Naltrexone monotherapy demonstrated significantly higher total abstinence ( 35 % ) compared with placebo ( 12 % , p = 0027 ) and longer , but not statistically different , Time to First Heavy Drinking Day ( p = 0.093 ) . On secondary measures , naltrexone compared with placebo demonstrated significant improvements in percent days abstinent ( p = 0.024 ) and drinking-related consequences ( p = 0.02 ) . Combined sertraline and naltrexone did not differ from naltrexone alone . The pattern of findings was generally similar for the American Indian/Alaska Native sub sample . Naltrexone treatment response was significant within the group of 75 individuals who were homozygous for OPRM1 Asn40 allele . There was a small number of Asp40 carriers , precluding statistical testing of the effect of this allele on response . CONCLUSIONS Naltrexone can be used effectively to treat alcoholism in remote and rural communities , with evidence of benefit for American Indians and Alaska Natives . New models of care incorporating pharmacotherapy could reduce important health disparities related to alcoholism Given the evidence from retrospective studies indicating that alcohol-dependent patients with homozygous or heterozygous A118 G variant of the & mgr;-opioid receptor , OPRM1 , gene have significantly better outcomes when treated with naltrexone ; this study examined this prospect ively in 100 alcohol-dependent participants prescribed naltrexone for 12 weeks and offered six sessions of cognitive-behavioral therapy or intervention . Comparisons were made among OPRM1 genotypic groups on several outcome measures . Naltrexone treatment produced significant decreases in self-reported and objective indicators of alcohol use and craving from baseline ( P<0.0001 and 0.017 , respectively ) , particularly during the first 2 months of treatment , with 68 % completing the study . However , there was no evidence of a significant association between OPRM1 A118 G genotype and treatment success on any of the outcome measures . Therefore , while naltrexone was an effective treatment for alcohol dependence , the OPRM1 A118 G genotype was not a predictor of success Naltrexone has repeatedly been shown to reduce drinking in alcohol-dependent patients . Previous clinical research suggests that naltrexone may be more effective at reducing drinking among patients with high levels of alcohol craving at the beginning of treatment . In addition , laboratory studies suggest that naltrexone may be more efficacious among patients with a high familial loading of alcohol problems . We explored both of these possibilities in the context of the first 12-week phase of a double blind , placebo-controlled naltrexone trial . A total of 121 patients were r and omized to receive 100 mg/day naltrexone and 62 patients were r and omized to receive placebo . Both naltrexone and placebo were given in conjunction with a psychosocial intervention design ed to be integrated with the use of pharmacotherapy . This intervention was administered by nurse practitioners . Overall , patients r and omized to naltrexone reported drinking five or more drinks on fewer days than did placebo controls ( p = .04 ) . Interactions were observed between medication group assignment and both craving level prior to r and omization ( p = .02 ) and family loading of alcohol problems ( p = .05 ) . In both cases , the interaction was in the predicted direction . These data suggest that patients with high levels of alcohol craving or a strong family history of alcoholism are more likely to benefit from naltrexone treatment Acamprosate and naltrexone are effective medications in the treatment of alcoholism . However , effect sizes are modest . Pharmacogenomics may improve patient‐treatment‐matching and effect sizes . It is hypothesized that naltrexone exerts its effect through genetic characteristics associated with the dopaminergic/opioidergic positive reinforcement system , whereas acamprosate works through the glutamatergic/GABAergic negative reinforcement system . Alcohol‐dependent subjects were r and omly assigned to either acamprosate or naltrexone . Subjects participated in a cue‐exposure experiment at the day before and at the last day of medication . Reductions in cue‐induced craving and physiological cue reactivity were measured . Differential effects of naltrexone and acamprosate on these outcomes were tested for different polymorphisms of the opioid , dopamine , glutamate and GABA‐receptors . Significant matching effects were found for polymorphisms at the DRD2 , GABRA6 and GABRB2 gene . In addition , a trend was found for the OPRM1 polymorphism . This provides evidence for the matching potential of genotypes . It is expected that more effective treatments can be offered when genetic information is used in patient‐treatment‐matching CONTEXT Clinical trials have suggested a modest effect of naltrexone as a pharmacotherapy for alcoholism , and a recent study has suggested that the effects may be moderated by variations in the mu-opioid receptor gene ( OPRM1 ) . However , the mechanism by which naltrexone may be differentially effective as a function of the OPRM1 genotype is unclear . OBJECTIVES ( 1 ) To replicate and exp and on the association between the A118 G single nucleotide polymorphism(SNP ) of the OPRM1 gene and alcohol sensitivity , ( 2 ) to examine the effects of naltrexone on alcohol sensitivity , and ( 3 ) to test the A118 G SNP of the OPRM1 gene as a moderator
Output:
| Our results support the fact that the G allele of A118 G polymorphism of OPRM1 moderates the effect of naltrexone in patients with alcohol dependence .
This genetic marker may therefore identify a subgroup of individuals more likely to respond to this treatment |
MS213467 | ***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 authors have carried out a r and om study on 75 cases in order to evaluate objective ly the therapeutic methods usually employed in cases of dystocia in starting labour . These studies have shown the superiority of Syntocinon using an infusion together with epidural analgesia . This attitude goes against the methods of treatment usually used in France . The authors explain the reasons for their choice in the light of factors that they have observed using other therapeutic methods Objective To compare labour outcomes using aggressive or expectant management protocol OBJECTIVE To determine whether cervical dilatation at the time of placement of patient-requested epidural affects cesarean rates or lengths of labors in actively managed parturients . METHODS The charts of 255 women r and omized to active management of labor ( n = 125 ) or control protocol s ( n = 130 ) were review ed and stratified to early epidural placement ( up to 4 cm cervical dilatation ) versus late placement ( more than 4 cm ) . RESULTS Women with early epidural placement had shorter labors than those with late placement ( 11.6 + /- 4.6 versus 13.2 + /- 5.6 hours ; P = .02 ) . Active management reduced the length of labor compared with controls regardless of epidural timing , with a reduction of 1.4 hours in early epidural placement ( 10.9 + /- 4.7 versus 12.3 + /- 4.3 hours ; P = .04 ) and 3.6 hours in those with later placement ( 11.0 + /- 3.6 versus 14.6 + /- 6.2 hours ; P = .004 ) . Cesarean rates did not vary significantly ( early 14.5 % versus late 7.9 % ; P = .21 ) . Early epidural placement did not lengthen the second stage of labor or increase operative vaginal delivery rates . CONCLUSION Early epidural placement did not affect lengths of labor or cesarean rates and was actually associated with shorter labor compared with late epidural placement . Women managed actively in labor , regardless of timing of epidural placement , had shorter labors than controls BACKGROUND Active management of labor reduces the length of labor and rate of prolonged labor , but its effect on satisfaction with care , within a r and omized controlled trial , has not previously been reported . The study objectives were to establish if a policy of active management of labor affected any aspect of maternal satisfaction , and to determine the independent explanatory variables for satisfaction with labor care in a low-risk nulliparous obstetric population . METHODS Nulliparous women at National Women 's Hospital in Auckl and , New Zeal and , in spontaneous labor at term with singleton pregnancy , cephalic presentation , and without fetal distress were r and omized after the onset of labor to active management ( n = 320 ) or routine care ( n = 331 ) . Active management included early amniotomy , two-hourly vaginal assessment s , and early use of high dose oxytocin for slow progress in labor . Routine care was not prespecified . Maternal satisfaction with labor care was assessed by postal question naire at 6 weeks postpartum . Sensitivity analyses were performed , and logistic regression models were developed to determine independent explanatory variables for satisfaction . RESULTS Of the 651 women r and omized in the trial , 482 ( 74 % ) returned the question naires . Satisfaction with labor care was high ( 77 % ) and did not significantly differ by treatment group . This finding was stable when sensitivity analysis was performed . The first logistic regression model found independent associations between satisfaction and adequate pain relief , one-to-one midwifery care , adequate information and explanations by staff , accurate expectation of length of labor , not having a postpartum hemorrhage , and fewer than three vaginal examinations during labor . The second model found fewer than three vaginal examinations and one-to-one midwifery care as significant explanatory variables for satisfaction with labor care . CONCLUSIONS Active management did not adversely affect women 's satisfaction with labor and delivery care in this trial . Future studies should concentrate on measurement of potential predictors before and during labor The objective of our study was prospect ively compare the effect in the rate of cesarean section of active labor management and of traditional labor management in primiparas with physiological term pregnancy . From september 1 , 1993 to may 31 , 1994 , 145 primiparas with physiological term pregnancy were r and omly assigned to one group of active labor management ( study group , n = 75 ) and to one group of traditional labor management ( control group , n = 70 ) . Cesarean section rate was 9.3 % in the study group and 20 % in the control group ( p < 0.05 ) . There was no increase in fetal morbidity or mortality . Active labor management can reduce cesarean section rate in primiparas with physiological term pregnancy OBJECTIVE To compare the costs of a protocol of active management of labor with those of traditional labor management . DESIGN Cost analysis of a r and omized controlled trial . METHODS From August 1992 to April 1996 , we r and omly allocated 405 women whose infants were delivered at the University of New Mexico Health Sciences Center , Albuquerque , to an active management of labor protocol that had substantially reduced the duration of labor or a control protocol . We calculated the average cost for each delivery , using both actual costs and charges . RESULTS The average cost for women assigned to the active management protocol was $ 2,480.79 compared with an average cost of $ 2,528.61 for women in the control group ( P = 0.55 ) . For women whose infant was delivered by cesarean section , the average cost was $ 4,771.54 for active management of labor and $ 4,468.89 for the control protocol ( P = 0.16 ) . Spontaneous vaginal deliveries cost an average of $ 27.00 more for actively managed patients compared with the cost for the control protocol . CONCLUSIONS The reduced duration of labor by active management did not translate into significant cost savings . Overall , an average cost saving of only $ 47.91 , or 2 % , was achieved for labors that were actively managed . This reduction in cost was due to a decrease in the rate of cesarean sections in women whose labor was actively managed and not to a decreased duration of labor Objective To assess the risks and benefits associated with caesarean delivery compared with vaginal delivery . Design Prospect i ve cohort study within the 2005 WHO global survey on maternal and perinatal health . Setting 410 health facilities in 24 areas in eight r and omly selected Latin American countries ; 123 were r and omly selected and 120 participated and provided data Participants 106 546 deliveries reported during the three month study period , with data available for 97 095 ( 91 % coverage ) . Main outcome measures Maternal , fetal , and neonatal morbidity and mortality associated with intrapartum or elective caesarean delivery , adjusted for clinical , demographic , pregnancy , and institutional characteristics . Results Women undergoing caesarean delivery had an increased risk of severe maternal morbidity compared with women undergoing vaginal delivery ( odds ratio 2.0 ( 95 % confidence interval 1.6 to 2.5 ) for intrapartum caesarean and 2.3 ( 1.7 to 3.1 ) for elective caesarean ) . The risk of antibiotic treatment after delivery for women having either type of caesarean was five times that of women having vaginal deliveries . With cephalic presentation , there was a trend towards a reduced odds ratio for fetal death with elective caesarean , after adjustment for possible confounding variables and gestational age ( 0.7 , 0.4 to 1.0 ) . With breech presentation , caesarean delivery had a large protective effect for fetal death . With cephalic presentation , however , independent of possible confounding variables and gestational age , intrapartum and elective caesarean increased the risk for a stay of seven or more days in neonatal intensive care ( 2.1 ( 1.8 to 2.6 ) and 1.9 ( 1.6 to 2.3 ) , respectively ) and the risk of neonatal mortality up to hospital discharge ( 1.7 ( 1.3 to 2.2 ) and 1.9 ( 1.5 to 2.6 ) , respectively ) , which remained higher even after exclusion of all caesarean deliveries for fetal distress . Such increased risk was not seen for breech presentation . Lack of labour was a risk factor for a stay of seven or more days in neonatal intensive care and neonatal mortality up to hospital discharge for babies delivered by elective caesarean delivery , but rupturing of membranes may be protective . Conclusions Caesarean delivery independently reduces overall risk in breech presentations and risk of intrapartum fetal death in cephalic presentations but increases the risk of severe maternal and neonatal morbidity and mortality in cephalic presentations The aim of this r and omised trial was to determine the effect of the policy of active management of labour in all its components on the rate of caesarean section in a Nigerian district hospital setting . Two hundred and twenty-one nulliparous women fulfilling selected inclusion criteria were r and omised to receive active management of labour , and 227 control women received routine labour management . Labour was significantly shortened by over 2 hours with active management of labour , and caesarean section reduced ( 9 % vs. 16 % , RR 0.57 , 95 % CI 0.34 - 0.95 ) . There were no significant differences in maternal infectious morbidity , uterine hyperstimulation syndromes , ruptured uterus or neonatal Apgar scores between the two groups . We conclude that active management of labour shortens primigravid labour and reduces caesarean risk OBJECTIVE Much of fever during term labor may not be infectious but rather a consequence of the use of epidural analgesia . Therefore , we investigated the association of elevated maternal intrapartum temperature with neonatal outcome when the infant does not develop an infection . METHODS We studied 1218 nulliparous women with singleton , term pregnancies in a vertex presentation and spontaneous labor . Women were excluded if their temperature was > 99.5 degrees F at admission for delivery , if they were diabetic or had an active genital herpes infection or if their infant developed a neonatal infection , had a congenital infection , or had a major malformation . Maximum intrapartum temperature was categorized as : < /=100.4 degrees F ( afebrile ) , 100.5 degrees F to 101 degrees F , and > 101 degrees F. RESULTS During labor , 123 women ( 10.1 % ) developed a fever > 100.4 degrees F ; 62 ( 5.1 % ) women had a maximum temperature of 100.5 degrees F to 101 degrees F and 61 ( 5.0 % ) women had a maximum temperature > 101 degrees F. Of febrile women , 97.6 % had received epidural analgesia for pain relief . Infants of women developing a fever > 100.4 degrees F were more likely to have a 1-minute Apgar score < 7 ( 22.8 % for > 100.4 degrees F vs 8.0 % for afebrile ) and to be hypotonic after delivery ( 4.8 % for > 100.4 degrees F vs.5 % for afebrile ) . Compared with infants of afebrile women , infants whose mothers ' maximum temperature was > 101 degrees F were more likely to require bag and mask resuscitation ( 11.5 % vs 3.0 % ) and to be given oxygen therapy in the nursery ( 8.2 % vs 1.3 % ) . We also found a higher rate of neonatal seizure with fever ( 3.3 % vs.2 % ) , but the number of infants with seizure was small ( n = 4 ) . All associations remained essentially the same after controlling for confounding in logistic regression analyses . CONCLUSIONS Intrapartum maternal fever , particularly if > 101 degrees F , was associated with a number of apparently transient adverse effects in the newborn . Larger studies are needed to investigate the association of intrapartum fever with neonatal seizures and to determine whether any lasting injury to the fetus may occur BACKGROUND Over the past two decades , the rate of cesarean section in the United States has risen from 5 percent to 25 percent of deliveries , primarily because of the increased frequency of dystocia ( arrest of labor ) . One strategy that has been proposed for increasing the rate of vaginal delivery is a program of active management of labor that encourages early amniotomy , early diagnosis of slow progress in labor , and the use of higher than usual doses of oxytocin ; the efficacy and safety of this approach are uncertain , however . METHODS We conducted a r and omized trial in which nulliparous women in spontaneous labor at term were r and omly assigned to either active management of labor or traditional management . With active management , amniotomy was performed within one hour of the diagnosis of labor , and when the rate of cervical dilation was less than 1 cm per hour , oxytocin was infused at an initial rate of 6 mU per minute . The dose was increased by 6 mU per minute every 15 minutes ( to a maximum of 36 mU per minute ) until there were seven contractions every 15 minutes . RESULTS For the women assigned to active management ( n = 351 ) , the cesarean-section rate was 10.5 percent , as compared with 14.1 percent for those assigned to traditional management ( n = 354 , P = 0.18 ) . The 26 percent reduction in the cesarean-section rate was due primarily to a decrease in dystocia . After we controlled for potential confounding variables , the reduction in the rate of delivery by cesarean section was statist
Output:
| Active management is associated with small reductions in the CS rate , but it is highly prescriptive and interventional .
It is possible that some components of the active management package are more effective than others . |
MS213468 | ***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: Forty patients who were scheduled for a total hip arthroplasty were enrolled in a prospect i ve study and were r and omly divided into two groups . Group 1 received recombinant human erythropoietin ( 300 U/kg twice a week ) , and group 2 received placebo . The medication was started 2 weeks before the operation , and only one dose of medication was given after the operation . Autologous blood was administered at the same time as the medication until the hemoglobin level sank to 10 g/dl . Forty-eight and 49 units of autologous blood were collected in group 1 and group 2 , respectively . Intraoperative homologous blood was transfused only to patients in group 2 . Seven and 13 units of allogenic blood were transfused into group 1 and group 2 patients during the postoperative period , respectively . There were no any significant differences between the groups in terms of early postoperative hemoglobin level and amount of autologous blood collected . However , the increase of the reticulocyte count in patients who received erythropoietin was significantly higher than in the group 2 patients . The study showed that short-term and low-dose erythropoietin usage strongly stimulates the bone marrow . Erythropoietin administration and preoperative autologous blood donation diminished the total units of allogenic blood required during the intraoperative or postoperative pe-riod . Autologous blood administration without concurrent erythropoietin did not stimulate the bone marrow adequately This prospect i ve r and omized trial compared preoperative autologous blood donation ( PAD ) with epoetin alfa in patients undergoing primary total knee reconstruction . Fifty adult patients with pretreatment hemoglobin level of 100 to 130 g/L were r and omized to either epoetin alfa 40,000 U at preoperative days 14 and 7 or to a st and ard PAD protocol . Patient characteristics and operative blood loss were similar between groups . Baseline hematological parameters for epoetin alfa vs PAD were not significantly different ; however , by the day of surgery the epoetin alfa group had significantly higher hemoglobin ( 130 vs 114 g/L ; P < .001 ) , hematocrit ( 0.408 vs 0.352 ; P < .001 ) , and reticulocyte count ( 3.4 vs 2.1 x 10(9 ) cells per liter ; P < .001 ) . These differences remained significant for 1 to 2 days postoperatively . There was no significant difference in the incidence of allogeneic transfusions between groups ( 28 % for epoetin alfa vs 8 % for PAD ; P = .1383 ) . Both treatments were generally well tolerated . Epoetin alfa appears to be a safe alternative to PAD in patients who are at risk for transfusion in the perioperative period following total knee arthroplasty Abstract Recombinant human erythropoietin ( rHuEPO ) is effective in allowing autologous blood donation in patients unable to donate because of anemia . As adverse effects of rHuEPO might include activation of coagulation and possibly fibrinolysis , we investigated these possibilities in the context of autologous blood donation preceding hip surgery . Thirty-seven patients who donated 800 ml of autologous blood for elective hip surgery were r and omly assigned to either a group of 20 receiving preoperative treatment with rHuEPO ( erythropoietin β ) , 6000 U i.v . twice weekly for 3 weeks , or an untreated control group of 17 . A significant increase in platelet count was associated with autologous blood donation and intraoperative blood loss with or without rHuEPO . Coagulation and fibrinolysis were increased significantly by intraoperative blood loss in both groups , but not by rHuEPO . Coagulation and fibrinolysis were not activated by rHuEPO for elective hip surgery In a prospect i ve r and omized study we investigated the potential of subcutaneous recombinant human erythropoietin ( rhEpo ) as adjuvant treatment for autologous blood transfusions ( 3 units ) in elective surgery . Four and 2 weeks before surgery , 49 patients received 6 x 10,000 U of rhEpo . delta Hb values ( days -28 and 0 ) of the rhEpo group were compared to delta Hb values of 52 controls ( no rhEpo ) . Reticulocytes were measured at days -21 , -14 , -7 and 0 . Peri- and postoperative supplementary homologous blood requirements were compared in the two r and omized groups . delta Hb of rhEpo group was 0.96 g/dl ( mean value ) and 2.38 for controls . Reticulocyte count increased earlier and to higher levels in rhEpo-treated patients . Except in 1 case , Epo was well tolerated . These results indicate that autologous predonation ( 3 x 400 ml ) does not create anemia if adjuvant Epo treatment is given . However , homologous blood requirements were not significantly different , which is probably due to the fact that 96 of the 101 treated patients underwent elective orthopedic surgery requiring limited blood replacement . Significant benefit of the Epo regimen can be expected in elective cardiovascular and hepatic surgery where larger amounts of blood ( 5 - 6 units ) are needed BACKGROUND The increasing incidence of osteoporotic hip fracture ( HF ) has raised the requirements of red blood cell ( RBC ) transfusions , whereas this scarce re source may cause morbidity and mortality . STUDY DESIGN AND METHODS This study was a multicenter , r and omized , double-blind , clinical trial that aim ed to assess efficacy of ferric carboxymaltose ( FCM ) with or without erythropoietin ( EPO ) in reducing RBC transfusion in the perioperative period of HF . Participants ( patients > 65 years admitted with HF and hemoglobin [ Hb ] levels of 90 - 120 g/L ) were r and omly assigned to receive a preoperative single dose of 1 g of FCM ( short intravenous [ IV ] infusion over 15 min ) , plus 40,000 IU of subcutaneous EPO ( EPOFE arm ) ; versus 1 g of IV FCM plus subcutaneous placebo ( FE arm ) ; and versus IV and subcutaneous placebo ( placebo arm ) . Primary endpoint was the percentage of patients who received RBC transfusion , and secondary endpoints were the number of RBC transfusions per patient , survival , hemoglobinemia , and health-related quality of life ( HRQoL ; by means of Short Form 36 Version 2 question naire ) . RESULTS A total of 306 patients ( 85 % women , mean age 83 ± 6.5 years ) were included . A total of 52 , 51.5 , and 54 % of patients required RBC transfusion in the EPOFE , FE , and placebo arms , respectively , with no significant differences in the number of RBC transfusions per patient , survival , HRQoL , and adverse events among treatment groups . A significant increase in Hb levels was achieved at discharge ( 102 g/L vs. 97 g/L ) and 60 days after discharge ( 125 g/L vs. 119 g/L ) in the EPOFE arm with respect to placebo arm ; in addition , a higher rate of patients recovered from anemia in the EPOFE arm with respect to the placebo arm ( 52 % vs. 39 % ) , 60 days after discharge . CONCLUSION Preoperative treatment with FCM alone or in combination with EPO improved recovery from postoperative anemia , but did not reduce the needs of RBC transfusion in patients with HF Total hip joint arthroplasty is frequently associated with transfusion of allogeneic blood ( 1 , 2 ) . Although serologic screening has reduced the risk for viral infection to a low level ( 3 , 4 ) , the public is highly concerned about this potential complication of transfusion ( 5 ) . Therefore , further refinement of strategies to avoid exposure to allogeneic blood is needed . The most commonly used preventive strategy is autologous blood donation ( 6 ) . Blood is collected from the patient before surgery and is reinfused if transfusion is necessary . In the past decade , this maneuver , which reduces exposure to pathogens and red cell alloimmunization , has become a st and ard of care in orthopedic surgery ( 7 , 8) . However , autologous blood donation has several disadvantages . First , donation and banking of autologous blood are inconvenient to patients ( 9 , 10 ) . Second , phlebotomy increases the prevalence of postoperative anemia and transfusion ( either autologous or allogeneic ) ( 11 ) . Third , use of autologous blood is not without risk ( 12 , 13 ) . Bacterial contamination of predonated blood ( 14 ) and major transfusion reactions ( due to administrative error ) ( 15 ) are rare but may be life-threatening . Finally and most important , many patients are not eligible for predonation because of concomitant medical conditions ( 16 ) . Erythropoietin , a glycoprotein produced by the kidney , stimulates production of red blood cells from the bone marrow ( 17 ) . Administration of recombinant human erythropoietin ( epoetin alfa ) reduces the risk for allogeneic blood transfusion in patients undergoing total hip joint arthroplasty ( 18 , 19 ) . Factors that influence the response to epoetin alfa include the dose and timing of treatment ( 20 ) , coadministration of iron ( 21 , 22 ) , and baseline hemoglobin concentration ( 23 ) . Although several different preoperative regimens have been described , the regimen approved by the U.S. Food and Drug Administration consists of four subcutaneous injections of epoetin alfa , 600 U/kg of body weight , administered before surgery ( weeks 3 , 2 , and 1 and the day of surgery ) ( 24 ) . Thus , a person weighing 70 kg would require a total dose of 168 000 U. On the basis of subgroup analysis from a previous study ( 18 ) , we hypothesized that a high dose of oral iron used in conjunction with a more prolonged epoetin alfa dosing schedule might produce a better hematologic response than that obtained with the st and ard regimen . We therefore evaluated the efficacy of two different epoetin alfa dose regimens . Methods Patients The study was a double-blind , r and omized , parallel-group , multicenter clinical trial comparing the efficacy of epoetin alfa ( Eprex , Janssen-Ortho Inc. , Toronto , Ontario , Canada ) with placebo in adult patients undergoing total hip joint arthroplasty . The trial was conducted at 13 teaching and 4 community hospitals in Canada from May 1996 to April 1999 . The protocol was approved by the institutional review board of each participating center . Eligible patients had a hemoglobin concentration of 98 to 137 g/L and did not predonate blood . At centers where an autologous blood donation program was available , blood predonation was discussed with patients ; those who participated in the study were either ineligible for predonation because of medical contraindication or declined this option . Persons with rheumatoid arthritis , recent gastrointestinal or intracranial bleeding , iron deficiency , seizures , blood dyscrasias , or uncontrolled hypertension ( diastolic blood pressure>100 mm Hg ) were excluded from the study . Patients who required revision arthroplasty or those in whom red cell salvage devices were considered essential were not enrolled . All patients gave written informed consent . Baseline and R and omization Procedures Participants were screened for eligibility 7 weeks before surgery . A history and physical examination were performed , and a complete blood count , iron studies , and blood chemistry were obtained ; patients then began oral iron therapy . Six weeks before surgery , eligible patients were r and omly assigned to one of three treatment groups . R and omization was performed according to a computer-generated schedule using a block size of 13 and an allocation ratio of 3:5:5 to the high-dose epoetin group , low-dose epoetin group , or placebo group , respectively . Treatment Regimens Patients began daily oral iron therapy at least 42 days before surgery and continued therapy until the day of hospital discharge . Three capsules per day were recommended . In patients who were intolerant of iron , the number of capsules was reduced to the point of tolerability . The iron preparation prescribed was Niferex-150 ( Schwarz Pharma , Mequon , Wisconsin ) . This polysaccharideiron complex was selected because of its good tolerability and high bioavailability of elemental iron ( 150 mg per capsule ) ( 25 ) . Patients received four weekly subcutaneous injections of placebo , high-dose epoetin alfa ( 40 000 U ) , or low-dose epoetin alfa ( 20 000 U ) starting 4 weeks before surgery . The total possible dose was 160 000 U in the high-dose group and 80 000 U in the low-dose group . The study drug was withheld if the hemoglobin concentration was 150 g/L or more , systolic blood pressure was 200 mm Hg or more , or the diastolic blood pressure was 105 mm Hg or more . During the trial , the study coordinator at the data coordinating center , who was aware of the patient 's hemoglobin concentration , authorized administration of study drug before each visit . This person had no contact with patients
Output:
| The results also indicated EPO does not increase the risk of a venous thromboembolism event .
Conclusion Preoperative administration of EPO was shown to generally increase Hb levels during the whole perioperative period ; however , the extent of the positive effects varies with time points .
Additionally , EPO minimizes the need for transfusion significantly in patients undergoing hip or knee surgery without increasing the chance of developing thrombotic complications .
Therefore , EPO offers an alternative blood management strategy in total hip arthroplasty and total knee arthroplasty |
MS213469 | ***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 test the hypothesis that an experienced surgeon is associated with less postoperative nausea and vomiting ( PONV ) BACKGROUND Combination therapy has been widely used for the clinical management of acute pain . By combining 2 drugs with different mechanisms of action , such therapy provides additive analgesic effects while reducing the risk for adverse effects . OBJECTIVE This study compared the efficacy and tolerability of oxycodone 5 mg/ibuprofen 400 mg with those of oxycodone 5 mg/acetaminophen 325 mg , hydrocodone 7.5 mg/acetaminophen 500 mg , and placebo in a dental pain model . METHODS This was a multicenter , r and omized , double-blind , placebo- and active-controlled , parallel-group , single-dose study in patients experiencing moderate to severe pain after surgical removal of > or = 2 ipsilateral impacted third molars . Patients were r and omly assigned to receive oxycodone 5 mg/ibuprofen 400 mg , oxycodone 5 mg/acetaminophen 325 mg , hydrocodone 7.5 mg/acetaminophen 500 mg , or placebo . The primary outcome measures were total pain relief through 6 hours after dosing ( TOTPAR6 ) , sum of pain intensity differences through 6 hours ( SPID6 ) , and adverse events . Secondary efficacy measures included SPID3 and TOTPAR3 , peak pain relief , peak pain intensity difference , time to onset of pain relief , time to use of rescue medication , proportion of patients reporting pain half gone , and the patient 's global evaluation . RESULTS Two hundred forty-nine patients ( 43.5 % male ; 87.5 % white ; mean age , 19.1 years ; mean body weight , 153.6 pounds ) were r and omized to treatment as follows : 62 to oxycodone 5 mg/ibuprofen 400 mg , 61 to oxycodone 5 mg/acetaminophen 325 mg , 63 to hydrocodone 7.5 mg/acetaminophen 500 mg , and 63 to placebo . Oxycodone 5 mg/ibuprofen 400 mg provided significantly greater analgesia compared with oxycodone 5 mg/acetaminophen 325 mg , hydrocodone 7.5 mg/acetaminophen 500 mg , and placebo ( mean [ SD ] TOTPAR6 , 14.98 [ 5.37 ] , 9.53 [ 6.77 ] , 8.36 [ 6.68 ] , and 5.05 [ 6.49 ] , respectively ; P < 0.001 , oxycodone 5 mg/ibuprofen 400 mg vs all other treatments ) . SPID6 values also differed significantly for oxycodone 5 mg/ibuprofen 400 mg compared with all other treatments ( mean : 7.78 [ 4.11 ] , 3.58 [ 4.64 ] , 3.32 [ 4.73 ] , and 0.69 [ 4.85 ] ; P < 0.001 ) . Oxycodone 5 mg/ibuprofen 400 mg was significantly more effective compared with the other treatments on all secondary end points ( P < 0.001 , all variables except peak PID vs oxycodone 5 mg/acetaminophen 325 mg [ P = 0.006 ] ) , with the exception of the time to onset of analgesia . The lowest frequency of nausea and vomiting occurred in the groups that received oxycodone 5 mg/ibuprofen 400 mg ( 6.5 % and 3.2 % , respectively ) and placebo ( 3.2 % and 1.6 % ) . Rates of nausea and vomiting were significantly lower with oxycodone 5 mg/ibuprofen 400 mg compared with oxycodone 5 mg/acetaminophen 325 mg ( P = 0.011 and P = 0.009 , respectively ) but not with hydrocodone 7.5 mg/acetaminophen 500 mg . CONCLUSIONS In this study in patients with moderate to severe pain after surgery to remove impacted third molars , oxycodone 5 mg/ibuprofen 400 mg provided significantly better analgesia throughout the 6-hour study compared with the other opioid/nonopioid combinations tested , and was associated with fewer adverse events In this double-blind , parallel-group study , we compared 3 oxymorphone immediate-release ( IR ) doses with placebo for efficacy and with oxycodone IR and placebo for safety in patients with acute moderate-to-severe postsurgical pain . During the single-dose phase ( n = 300 ) , patients received oxymorphone IR 10 , 20 , or 30 mg ; oxycodone IR 10 mg ; or placebo . All oxymorphone IR doses were superior for providing pain relief for 8 h ( P < 0.05 ) , with a significant analgesic dose response ( P < 0.001 ) . Significant pain intensity differences occurred by 45 min ( 20- and 30-mg doses ; P < 0.05 ) . Discontinuations for lack of efficacy totaled 42 % among placebo-treated patients and 27 % among those treated with oxymorphone IR . Patients requiring rescue medication after 3 h were allowed to receive additional study drug every 4 to 6 h as needed for the multiple-dose phase ( n = 164 ) . All oxymorphone groups maintained analgesia for 48 h. The median dosing interval was > 9.5 h for oxymorphone IR 30 mg and ≥7 h for the other groups . Opioid-related adverse events , similar among groups , were generally mild or moderate . Oxymorphone IR 10 , 20 , or 30 mg provided significant dose-related pain relief compared with placebo , and this relief was maintained over several days with a safety profile comparable to that of oxycodone IR The analgesic efficacy of the combination of a nonsteroidal anti-inflammatory drug , flurbiprofen , and a long-acting local anesthetic , etidocaine , was evaluated for the suppression of acute postoperative pain . Subjects having two impacted third molars removed at two appointments received either the experimental combination or st and ard treatment in a r and omized , crossover design . The experimental treatment consisted of 100 mg flurbiprofen 30 minutes before surgery , 1.5 % etidocaine with 1:200,000 epinephrine five minutes before surgery , and 100 mg flurbiprofen three hours after surgery . St and ard treatment consisted of 10 mg oxycodone plus 650 mg acetaminophen 30 minutes before surgery , 2 % lidocaine with 1:100,000 epinephrine five minutes before surgery , and a second dose of the oxycodone-acetaminophen combination three hours after surgery . Pain intensity was rated hourly from one to seven hours after surgery , using a variety of ordinal and analog scales . The flurbiprofen-etidocaine combination result ed in significantly less postoperative pain than the oxycodone plus acetaminophen-lidocaine combination on all four analgesic scales used and was preferred by the majority of the patients . This study shows that pretreatment with a nonsteroidal anti-inflammatory drug , flurbiprofen , in combination with a long-acting local analgesic , etidocaine , suppresses pain to a greater extent than a potent opiate mild/analgesic combination and lidocaine without an increase in side-effect liability STUDY OBJECTIVE To determine whether the addition of morphine to the axillary block local anesthetic solution provides improved or prolonged postoperative analgesia . DESIGN Prospect i ve , r and omized , double-blind clinical trial with 24-hour follow-up . SETTING Ambulatory unit of a large academic referral center . PATIENTS Consecutive healthy volunteers scheduled for elective upper extremity surgery . INTERVENTIONS Patients in the treatment group ( AX ) were given intravenous ( IV ) saline and had morphine 0.1 mg/kg added to their axillary block solution . Control subjects ( CT ) received morphine 0.1 mg/kg IV and had saline added to their axillary block solution . All axillary blocks were performed using 0.55 ml/kg of 1.5 % lidocaine with epinephrine 1:200,000 . MEASUREMENTS AND MAIN RESULTS During the first 24 hours after surgery , visual analog scale ( VAS ) scores , supplementary analgesic ( oxycodone 5 mg with acetaminophen 500 mg ) use , and complications were recorded . Both groups had similar VAS scores throughout the study . In the 24-hour postoperative study period , AX patients required approximately half as many doses ( median , 2 doses ; range , 0 to 7 doses of supplemental analgesic as CT patients ( median , 4 doses ; range , 0 to 12 doses ) . There were no major complications in either group . CONCLUSIONS The addition of morphine 0.1 mg/kg to the local anesthetic axillary block solution provided improved postoperative analgesia without an increased frequency of side effects or major complications Fifty – four orthopaedic patients were given either indomethacin ( 25–50 mg bolus plus infusion , 5–7.5 mg h‐1 ) or only lactated Ringer solution intravenously over 20 h in a r and omized and double – blind fashion . The study was started at the casualty department as soon as possible after the decision to operate was made . The patients were given a spinal block with bupivacaine , and the evaluation included postoperative analgesia and IVY bleeding times . Indomethacin plasma concentrations were measured and found to be at a therapeutic level throughout the study . The oxycodone dose ( mean s.d . ) during the postoperative observation was lower in the indomethacin group ( 17.4 13.7 mg ) than in the control group ( 25.6 15.6 mg ) ( P = 0.05 ) . Fewer patients in the indomethacin group needed oxycodone more than once during the follow – up period ( P < 0.001 ) . The mean IVY bleeding time was prolonged in the indomethacin group after 20 h of infusion ( P < 0.05 ) . No abnormal bleeding was observed immediately postoperatively . However , at the end of the infusion there were more patients who bled through their b and ages and casts in the indomethacin group ( 4/28 vs. 1/26 ) Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size Sixty patients who were scheduled to have an elective total hip or knee arthroplasty were r and omly assigned to one of three groups of twenty patients each before operation with spinal anesthesia . A double-blind technique was used throughout the study . The patients in Group I ( control group ) received hyperbaric 1 per cent tetracaine with epinephrine as the subarachnoid spinal anesthetic ; the patients in Group II ( morphine group ) , hyperbaric 1 per cent tetracaine with epinephrine and a single subarachnoid dose of Duramorph ( morphine sulphate ) , 0.5 milligram ; and those in Group III ( Dilaudid group ) , hyperbaric 1 per cent tetracaine with epinephrine and a single sub
Output:
| Adverse events occurred more frequently with combination therapy than placebo , but were generally described as mild to moderate in severity and rarely led to withdrawal .
Single dose oxycodone is an effective analgesic in acute postoperative pain at doses over 5 mg ; oxycodone is two to three times stronger than codeine .
Efficacy increases when combined with paracetamol .
Oxycodone 10 mg plus paracetamol 650 mg provides good analgesia to half of those treated , comparable to commonly used non-steroidal anti-inflammatory drugs , with the benefit of longer duration of action |
MS213470 | ***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 There has been little rigorous economic analysis of the relationship between asthma and improved housing . AIM To evaluate the cost-effectiveness of installing ventilation systems , and central heating if necessary , in homes of children with ' moderate ' or ' severe ' asthma . DESIGN AND SETTING An incremental cost-effectiveness analysis alongside a pragmatic r and omised controlled trial of a tailored package of housing modifications design ed to improve ventilation and household heating in homes within Wrexham County Borough , Wales , UK . METHOD A total of 177 children aged between 5 and 14 years , identified from general practice registers , were studied . Parents reported on the quality of life of their children over a 12-month period . General practice s reported on health-service re sources used by those children , and their asthma-related prescriptions , over the same period . RESULTS The tailored package shifted 17 % of children in the intervention group from ' severe ' to ' moderate ' asthma , compared with a 3 % shift in the control group . The mean cost of these modifications was £ 1718 per child treated or £ 12300 per child shifted from ' severe ' to ' moderate ' . Healthcare costs over 12 months following r and omisation did not differ significantly between intervention and control groups . Bootstrapping gave an incremental cost-effectiveness ratio ( ICER ) of £ 234 per point improvement on the 100-point PedsQL ™ asthma-specific scale , with 95 % confidence interval ( CI ) = £ 140 to £ 590 . The ICER fell to £ 165 ( 95 % CI = £ 84 to £ 424 ) for children with ' severe ' asthma . CONCLUSION This novel and pragmatic trial , with integrated economic evaluation , reported that tailored improvement of the housing of children with moderate to severe asthma is likely to be a cost-effective use of public re sources . This is a rare example of evidence for collaboration between local government and the NHS Background Improvements in health are an important expected outcome of many housing infrastructure programs . The authors aim ed to determine if improvement in the notoriously poor housing infrastructure in Australian Indigenous communities results in reduction in common childhood illness and to identify important mediating factors in this relationship . Methods The authors conducted a prospect i ve cohort study of 418 children aged 7 years or younger in 10 Australian Indigenous communities , which benefited most substantially from government-funded housing programs over 2004–2005 . Data on functional and hygienic state of houses , reports of common childhood illness and on socio-economic conditions were collected through inspection of household infrastructure and interviews with children 's carers and householders . Results After adjustment for a range of potential confounding variables , the analysis showed no consistent reduction in carers ' reporting of common childhood illnesses in association with improvements in household infrastructure , either for specific illnesses or for these illnesses in general . While there was strong association between improvement in household infrastructure and improvement of hygienic condition of the house , there were only marginal improvements in crowding . Conclusions High levels of household crowding and poor social , economic and environmental conditions in many Australian Indigenous communities appear to place major constraints on the potential for building programs to impact on the occurrence of common childhood illness . These findings reinforce the need for building programs to be supported by a range of social , behavioural and community-wide environmental interventions in order for the potential health gains of improved housing to be more fully realised BACKGROUND Few robust studies have tested whether enhancing housing also improves health . AIM To evaluate the effectiveness of installing ventilation systems , and central heating where necessary , in the homes of children with moderate or severe asthma . DESIGN AND SETTING Pragmatic r and omised controlled trial ( RCT ) in homes within Wrexham County Borough , Wales , UK . METHOD A pragmatic RCT was carried out , of a tailored package of housing improvements providing adequate ventilation and temperature , following inspection by a housing officer . One hundred and ninety-two children with asthma aged 5 to 14 years , identified from general practice registers , were r and omised to receive this package , either immediately or a year after recruitment . At baseline , and after 4 and 12 months , parents reported their child 's asthma-specific and generic quality of life , and days off school . RESULTS The package improved parent-reported asthma-specific quality of life significantly at both 4 and 12 months . At 12 months , this showed an adjusted mean difference between groups of 7.1 points ( 95 % confidence interval [ CI ] = 2.8 to 11.4 , P= 0.001 ) : a moderate st and ardised effect size of 0.42 . The generic quality -of-life scale showed reported physical problems were significantly reduced at 4 months , but not quite at 12 months , when the mean difference was 4.5 ( 95 % CI = -0.2 to 9.1 , P= 0.061 ) . The improvement in psychosocial quality of life at 12 months was not significant , with a mean difference of 2.2 ( 95 % CI = -1.9 to 6.4 , P= 0.292 ) . Parent-reported school attendance improved , but not significantly . CONCLUSION This novel and pragmatic trial , with integrated economic evaluation , found that tailored improvement of the housing of children with moderate to severe asthma significantly increases parent-reported asthma-related quality of life and reduces physical problems . Collaborative housing initiatives have potential to improve health Background : It is not clear whether associations between respiratory symptoms and indoor mould are causal . A r and omised controlled trial was conducted to see whether asthma improves when indoor mould is removed . Methods : Houses of patients with asthma were r and omly allocated into two groups . In one group , indoor mould was removed , fungicide was applied and a fan was installed in the loft . In the control group , intervention was delayed for 12 months . Question naires were administered and peak expiratory flow rate was measured at baseline , 6 months and 12 months . Results : Eighty-one houses were allocated to the intervention group and 83 to the control group ; 95 participants in 68 intervention houses and 87 in 63 control houses supplied follow-up information . Peak expiratory flow rate variability declined in both groups , with no significant differences between them . At 6 months , significantly more of the intervention group showed a net improvement in wheeze affecting activities ( difference between groups 25 % , 95 % CI 3 % to 47 % ; p = 0.028 ) , perceived improvement of breathing ( 52 % , 95 % CI 30 % to 74 % ; p<0.0001 ) and perceived reduction in medication ( 59 % , 95 % CI 35 % to 81 % ; p<0.0001 ) . By 12 months the intervention group showed significantly greater reductions than the controls in preventer and reliever use , and more improvement in rhinitis ( 24 % , 95 % CI 9 % to 39 % ; p = 0.001 ) and rhinoconjunctivitis ( 20 % , 95 % CI 5 % to 36 % ; p = 0.009 ) . Conclusions : Although there was no objective evidence of benefit , symptoms of asthma and rhinitis improved and medication use declined following removal of indoor mould . It is unlikely that this was entirely a placebo effect In a field study carried out in three rural communities in Paraguay in a zone endemic for Chagas disease , we implemented three different vector control interventions --spraying , housing improvement , and a combination of spraying plus housing improvement -- which effectively reduced the triatomine infestation . The reduction of triatomine infestation was 100 % ( 47/47 ) in the combined intervention community , whereas in the community where housing improvement was carried out it was 96.4 % ( 53/55 ) . In the community where fumigation alone was used , the impact was 97.6 % ( 40/41 ) in terms of domiciliary infestation . In all the houses where an intervention was made , an 18-month follow-up showed reinfestation rates of less than 10 % . A serological survey of the population in the pre- and post-intervention periods revealed a shift in positive cases towards older age groups , but no significant differences were observed . The rate of seroconversion was 1.3 % ( three new cases ) in the community with housing improvement only , but none of these cases could have result ed from vector transmission . The most cost-effective intervention was insecticide spraying , which during a 21-month follow-up period had a high impact on triatomine infestation and cost US$ 29 per house as opposed to US$ 700 per house for housing improvement An outst and ing feature of marginalized Roma communities is their severely subst and ard living conditions , which contribute to their worse health status compared to the majority . However , health consequences of international and local-level housing initiatives in most cases fail to be assessed prospect ively or evaluated after implementation . This paper summarizes the result of a retrospective health impact assessment of a Roma housing project in Hungary in comparison with the outcome evaluation of the same project . Positive impacts on education , in- and outdoor conditions were noted , but negative impacts on social networks , housing expenses and maintenance , neighbourhood satisfaction and no sustained change in health status or employment were identified . Recommendations are made to improve efficiency and sustainability of housing development initiatives among disadvantaged population Background New Zeal and homes are underheated by international st and ards , with average indoor temperatures below the WHO recommended minimum of 18 ° C . Research has highlighted the connection between low indoor temperatures and adverse health outcomes , including social functioning and psychological well-being . Both health effects and social effects can impact on school absence rates . The aim of this study was to determine whether more effective home heating affects school absence for children with asthma . Methods A single-blinded r and omised controlled trial of heating intervention in 409 households containing an asthmatic child aged 6–12 years , where the previous heating was an open fire , plug-in electric heater or unflued gas heater . The intervention was the installation of a more effective heater of at least 6 kW before the winter of 2006 in half the houses . Demographic and health information was collected both before and after the intervention . Each child 's school was contacted directly and term-by-term absence information for that child obtained for 2006 and previous years where available . Results Complete absence data were obtained for 269 out of 409 children . Compared with the control group , children in households receiving the intervention experienced on average 21 % ( p=0.02 ) fewer days of absence after allowing for the effects of other factors . Conclusion More effective , non-indoor polluting heating reduces school absence for asthmatic children RATIONALE Particulate air pollution is associated with cardiovascular morbidity . One hypothesized mechanism involves oxidative stress , systemic inflammation , and endothelial dysfunction . OBJECTIVES To assess an intervention 's impact on particle exposures and endothelial function among healthy adults in a woodsmoke-impacted community . We also investigated the underlying role of oxidative stress and inflammation in relation to exposure reductions . METHODS Portable air filters were used in a r and omized crossover intervention study of 45 healthy adults exposed to consecutive 7-day periods of filtered and nonfiltered air . MEASUREMENTS AND MAIN RESULTS Reactive hyperemia index was measured as an indicator of endothelial function via peripheral artery tonometry , and markers of inflammation ( C-reactive protein , interleukin-6 , and b and cells ) and lipid peroxidation ( malondialdehyde and 8-iso-prostagl and in F(2α ) ) were quantified . Air filters reduced indoor fine particle concentrations by 60 % . Filtration was associated with a 9.4 % ( 95 % confidence interval , 0.9 - 18 % ) increase in reactive hyperemia index and a 32.6 % ( 4.4 - 60.9 % ) decrease in C-reactive protein . Decreases in particulate matter and the woodsmoke tracer levoglucosan were associated with reduced b and cell counts . There was limited evidence of more pronounced effects on endothelial function and level of systemic inflammation among males , overweight participants , younger participants , and residents of wood-burning homes . No associations were noted for oxidative stress markers . CONCLUSIONS Air filtration was associated with improved endothelial function and decreased concentrations of inflammatory biomarkers but not markers of oxidative stress . Our results support the hypothesis that systemic inflammation and impaired endothelial function , both predictors of cardiovascular morbidity , can be favorably influenced by reducing indoor particle concentrations UNLABELLED Inuit infants have high rates of reported hospitalization for respiratory infection , associated with overcrowding and reduced ventilation . We performed a r and omized , double-blind , placebo controlled trial to determine whether home heat recovery ventilators ( HRV ) would improve ventilation and reduce the risk of respiratory illnesses in young Inuit children . Inuit children under 6 years of age living in several communities in Nunavut , Canada were r and omized to receive an active or placebo HRV . We monitored respiratory symptoms , health center encounters , and indoor air quality for 6 months . HRVs were placed in 68 homes , and 51 houses could be analyzed . Subjects had a mean age of 26.8 months . Active HRVs brought indoor carbon dioxide concentrations to within recommended concentrations . Relative humidity was also reduced . Use of HRV , compared with placebo , was associated with a progressive fall in the odds ratio for reported wheeze of 12.3 % per week ( 95%CI 1.9 - 21.6 % , P = 0.022 ) . Rates of reported rhinitis were significantly lower in the HRV group than the placebo group in month 1 ( odds ratio 0.20 , 95%CI 0.058 -
Output:
| Data from studies of warmth and energy efficiency interventions suggested that improvements in general health , respiratory health , and mental health are possible .
Studies which targeted those with inadequate warmth and existing chronic respiratory disease were most likely to report health improvement .
Impacts following housing-led neighbourhood renewal were less clear ; these interventions targeted areas rather than individual households in most need .
There were few reports of adverse health impacts following housing improvement .
Warmth improvements were associated with increased usable space , increased privacy , and improved social relationships ; absences from work or school due to illness were also reduced .
Housing investment which improves thermal comfort in the home can lead to health improvements , especially where the improvements are targeted at those with inadequate warmth and those with chronic respiratory disease .
The health impacts of programmes which deliver improvements across areas and do not target according to levels of individual need were less clear , but reported impacts at an area level may conceal health improvements for those with the greatest potential to benefit .
Best available evidence indicates that housing which is an appropriate size for the householders and is affordable to heat is linked to improved health and may promote improved social relationships within and beyond the household .
In addition , there is some suggestion that provision of adequate , affordable warmth may reduce absences from school or work . |
MS213471 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Summary Nonspecific placebo factors such as patients ' perceptions of a treatment and expectations toward effect seem to be central to the clinical efficacy of acupuncture analgesia . ABSTRACT It is well known that acupuncture has pain‐relieving effects , but the contribution of specific and especially nonspecific factors to acupuncture analgesia is less clear . One hundred one patients who developed pain of ≥3 on a visual analog scale ( VAS , 0 to 10 ) after third molar surgery were r and omized to receive active acupuncture , placebo acupuncture , or no treatment for 30 min with acupuncture needles with potential for double‐blinding . Patients ' perception of the treatment ( active or placebo ) and expected pain levels ( VAS ) were assessed before and halfway through the treatment . Looking at actual treatment allocation , there was no specific effect of active acupuncture ( P = .240 ) , but there was a large and significant nonspecific effect of placebo acupuncture ( P < .001 ) , which increased over time . Interestingly , however , looking at perceived treatment allocation , there was a significant effect of acupuncture ( P < .001 ) , indicating that patients who believed they received active acupuncture had significantly lower pain levels than those who believed they received placebo acupuncture . Expected pain levels accounted for significant and progressively larger amounts of the variance in pain ratings after both active and placebo acupuncture ( up to 69.8 % ) . This is the first study to show that under optimized blinding conditions , nonspecific factors such as patients ' perception of and expectations toward treatment are central to the efficacy of acupuncture analgesia and that these factors may contribute to self‐reinforcing effects in acupuncture treatment . To obtain an effect of acupuncture in clinical practice , it may therefore be important to incorporate and optimize these factors OBJECTIVE This study investigated the impact of the social modeling of side effects following placebo medication ingestion on the nocebo and placebo effect . It also investigated whether medication br and ing ( br and or generic labeling ) moderated social modeling effects . METHOD Eighty-two university students took part in the study which was purportedly investigating the impact of fast-acting beta-blocker medications ( actually placebos ) on preexamination anxiety . After taking the medication , participants were r and omized to either witness a female confederate report experiencing side effects or no side effects after taking the same medication . Differences in symptom reporting , blood pressure , heart rate , and anxiety were assessed between the social modeling of side effects and no modeling groups . RESULTS Seeing a female confederate report side effects reduced the placebo effect in systolic ( p = .009 ) and diastolic blood pressure ( p = .033 ) . Seeing a female confederate report side effects also increased both total reported symptoms ( mean [ SE ] 7.35 [ .54 ] vs. 5.16 [ 0.53 ] p = .005 ) and symptoms attributed to the medication ( 5.27 [ 0.60 ] vs. 3.04 [ 0.59 ] p = .01 ) , although the effect on symptoms was only seen in female participants . Females who saw the confederate report side effects reported approximately twice the number of symptoms as those in the no modeling group . Social modeling did not affect heart rate or anxiety . Medication br and ing did not influence placebo or nocebo outcomes . CONCLUSIONS The social modeling of symptoms can substantially reduce or eliminate the placebo effect . Viewing a female confederate display symptoms after taking the same medication increases symptom reporting in females Background : Expectancy and modeling have been cited as factors in mass psychogenic illness ( MPI ) , which reportedly affects more women than men . Purpose : The purpose of the study is to assess the effects of expectancy and modeling in a controlled laboratory analogue of MPI . Methods : Students were r and omly assigned to inhale or not inhale an inert placebo described as a suspected environmental toxin that had been linked to four symptoms typical of reported instances of MPI . Half of the students observed a female confederate inhale the substance and subsequently display the specified symptoms . Results : Students who inhaled the placebo reported greater increases in symptoms , and the increase was significantly greater for the specified symptoms than for other symptoms . Observation of the confederate displaying symptoms increased specified symptoms significantly among women but not among men . Changes in reported symptoms were significantly associated with changes in unobtrusively observed behavior . Conclusions : Symptoms typical of clinical reports of MPI can be induced by manipulating response expectancies , and the effects are specific rather than generalized . Among women , this effect is enhanced by observing another participant ( who in this study is also female ) display symptoms . This suggests that the preponderance of women showing symptoms in outbreaks of MPI may be due to gender-linked differences in the effects of modeling on psychogenic symptoms OBJECTIVES : Multiple chemical sensitivity is a poorly understood syndrome in which various symptoms are triggered by chemically unrelated , but often odorous substances , at doses below those known to be harmful . This study focuses on the process of pavlovian acquisition and extinction of somatic symptoms triggered by odours . METHODS : Diluted ammonia and butyric acid were odorous conditioned stimuli ( CS ) . The unconditioned stimulus ( US ) was 7.4 % CO2 enriched air . One odour ( CS+ ) was presented together with the US for 2 minutes ( CS+ trial ) , and the other odour ( CS- ) was presented with air ( CS-trial ) . Three CS+ and three CS-exposures were run in a semi-r and omised order ; this as the acquisition ( conditioning ) phase . To test the effect of the conditioning , each subject then had one CS+ only -- that is , CS+ without CO2 - - and one CS- test exposure . Next , half the subjects ( n = 32 ) received five additional CS+ only exposures ( extinction group ) , while the other half received five exposures to breathing air ( wait group ) . Finally , all subjects got one CS+ only test exposure to test the effect of the extinction . Ventilatory responses were measured during and somatic symptoms after each exposure . RESULTS : More symptoms were reported upon exposure to CS+ only than to CS-odours , regardless of the odour type . Altered respiratory rate was only found when ammonia was CS+ . Five extinction trials were sufficient to reduce the level of acquired symptoms . CONCLUSION : Subjects can acquire somatic symptoms and altered respiratory behaviour in response to harmless , but odorous chemical substances , if these odours have been associated with a physiological challenge that originally had caused these symptoms . The conditioned symptoms can subsequently be reduced in an extinction procedure . The study further supports the plausibility of a pavlovian conditioning hypothesis to explain the pathogenesis of MCS Abstract Medical treatment is usually accompanied by a warning about potential side effects . While constituting an important component of informed consent , these warnings may themselves contribute to side effects via the placebo effect . We tested this possibility using a 2 × 2 between-subjects design . Under the guise of a trial of a new hypnotic , 91 undergraduates experiencing difficulty sleeping were allocated to receive a warning about a target side effect ( either increase or decrease in appetite , counterbalanced ) or no warning and then to receive placebo treatment or no treatment for one week . Placebo treatment led to significantly better sleep on almost all self-reported outcomes , suggesting a placebo effect for reported sleep difficulty . Actigraphy recordings were unaffected by treatment . There was a clear effect of the warning in that placebo treated participants who were warned about side effects were much more likely to report the target side effect than those not warned about side effects . Implication s for clinical practice are discussed The nocebo effect is the onset of untoward reactions following the administration of an indifferent substance . The oral challenge with alternative drugs plays a central role in the management of drug allergy and the use of inert substances is part of this procedure . We evaluated the occurrence and clinical characteristics of nocebo effect in patients with adverse drug reactions . Six hundred patients , seen in three different centres ( Genoa , Naples and Verona ) with a history of reactions to drugs , underwent a blind oral challenge with the administration of an indifferent substance and active drugs . The administration of an inert substance provoked untoward reactions in 54 patients ( 27 % ) in Verona , 60 ( 30 % ) in Naples and 48 ( 24 % ) in Genoa . The overall occurrence of nocebo effect was 27 % . The majority of reactions were subjective symptoms ( itching , malaise , headache etc ) , perceived as troublesome by all subjects . The occurrence was significantly higher in women than in men . Our data , collected in a large population , confirm that the nocebo effect occurs frequently in clinical practice . In managing adverse drug reactions through oral challenge the nocebo effect is m and atory to recognize false positive responses Objective Generic medications are associated with reduced perceived effectiveness , increased perceived adverse effects , and increased rates of nonadherence compared with br and -name medications . This study examined the effect of an apparent medication formulation change on subjective and objective measures of medication effectiveness and medication side effects . Methods Sixty-two university students participated in a study purportedly testing the effectiveness of fast-acting & bgr;-blocker medications in reducing preexamination anxiety . All tablets were placebos . In session 1 , all participants received a yellow tablet ( “ Betaprol ” ) . In session 2 , participants were r and omly allocated to receive Betaprol ( no change condition ) or a white tablet labeled either as “ Novaprol ” ( br and ed change condition ) or “ Generic ” ( generic change condition ) . Blood pressure and state anxiety were measured before and after tablet ingestion . Side effects attributed to medication were assessed . Results The no change group showed significantly greater decreases in systolic blood pressure ( mean [ M ] [ st and ard deviation ] = −7.72 mm Hg , st and ard error [ SE ] = 1.45 ) than the br and ed change ( M = −2.75 mm Hg , SE = 1.44 , p = .02 ) and generic change ( M = −3.26 mm Hg , SE = 1.45 , p = .03 ) groups . The no-change group showed significantly greater decreases in state anxiety ( M = −1.53 , SE = 0.33 ) than the br and ed change ( M = −0.50 , SE = 0.33 , p = .03 ) and generic change ( M = −0.52 , SE = 0.33 , p = .04 ) groups . Significantly more side effects were attributed to the medication in the generic change ( M = 1.83 , SE = 0.23 ) ( but not the br and ed change ) condition when compared with the no change condition ( M = 0.87 , SE = 0.31 , p = .03 ) . Conclusions Medication formulation change , particularly to generic medication , seems to be associated with reduced subjective and objective measures of medication effectiveness and increased side effects Caffeine consumption , a ubiquitous cultural phenomenon with significant health implication s may be governed by some of the same principles which affect other drug use [ 1 ] . We hypothesized that pharmacological and expectancy effects may be two of those principles . A balanced placebo design was used with 100 male undergraduates to separate caffeine 's active drug effects from the expectancy of having consumed caffeine on mood , performance , and physiological measures . The manipulation of expectancies was highly effective on subjects ' judgments of caffeine dosage , regardless of actual caffeine content . As predicted , expectancy set and caffeine content appeared equally powerful , and worked additively , to affect subjects ' ratings of how much the coffee influenced their mood and performance . Main effects on systolic and diastolic blood pressure , pulse rate , and a fatigue measure were found for caffeine vs. no caffeine groups only . Additional increases in diastolic blood pressure for smokers were noted within the caffeine-receiving conditions . Results are discussed with heuristic and health implication 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 Abstract . Rationale : To test the classical conditioning and expectancy theories of placebo effects . Objective : Two experiments investigated whether administration of caffeine-associated stimuli elicited conditioned arousal , and whether information that a drink contained or did not contain caffeine modulated arousal . Method : Experiment 1 ( n=21 ) used a 2 Caffeine ( 0 and 2 mg/kg ) × 2 Solution ( Coffee , Juice ) × 2 Information ( Told caffeine , Told not-caffeine ) within-subjects design . Experiment 2 ( n=48 ) used a 2 Solution ( Coffee , Orange juice ) × 3 Information ( Told caffeine , Told not-caffeine , No information ) between-subjects design . Indexes of arousal were skin conductance responses and levels , startle eyeblink reflexes , cardiovascular measures , and the Bond and Lader 1974 mood scale . Results : Caffeine-associated stimuli increased alertness , contentedness and skin conductance levels , and information that the drink contained caffeine decreased calmness in Experiment 1 . However , unexpected information about the caffeine content of the drink , and the order of the conditions , could have masked some effects of the experimental manipulations . Experiment 2 followed up this hypothesis . The results showed a conditioned increase in startle eyeblink reflexes , and that caffeine-associated stimuli together with information that the drink contained caffeine increased contentedness . Conclusions : Caffeine-associated stimuli increased arousal , and information about the content of the drink modulated arousal in the direction indicated by the information . Thus , both the classical conditioning and expectancy theories of placebo effects received support , and placebo effects were strongest when both conditioned responses and expectancy-based responses acted in the same
Output:
| The strongest predictors of nocebo effects were a higher perceived dose of exposure , explicit suggestions that the exposure triggers arousal or symptoms , observing people experiencing symptoms from the exposure , and higher expectations of symptoms .
CONCLUSIONS To reduce nocebo induced symptoms associated with medication or other interventions clinicians could reduce expectations of symptoms , limit suggestions of symptoms , correct unrealistic dose perceptions , and reduce exposure to people experiencing side effects . |
MS213472 | ***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 clinical measurement comparison of a new measurement technique with an established one is often needed to see whether they agree sufficiently for the new to replace the old . Such investigations are often analysed inappropriately , notably by using correlation coefficients . The use of correlation is misleading . An alternative approach , based on graphical techniques and simple calculations , is described , together with the relation between this analysis and the assessment of repeatability The recommended method for assessing long-term blood glucose control in diabetic patients is the measurement of glycated haemoglobin ( Hb ) . The Ames DCA 2000 system for assaying glycated Hb uses an immunoassay with a monoclonal antibody specific for an aminoacid sequence within the HblAc molecule . This study compared the performance of the DCA 2000 system for HblAc measurement with that of high-performance liquid chromatography ( HPLC ) . A total of 1.016 insulin-dependent and non-insulin-dependent diabetic patients from 5 outpatient clinics took part . The correlation coefficients between DCA 2000 and HPLC data ranged between 0.94 and 0.98 , depending on site . The mean variations and 95 % confidence intervals for the differences between the results for each sample were : site A 0.172 ( -1.186 to 1.53 ) , site B -0.275 ( -1.317 to 0.767 ) , site C -0.146 ( -0.868 to 0.576 ) , site D -0.088 ( -0.864 to 0.688 ) , and site E -0.251 ( -1.099 to 0.597 ) . The sensitivity of the DCA 2000 assay ranged between 80 and 94 % , and the specificity between 88 and 100 % , depending on site . For pooled results , the correlation coefficient assayed by the two methods was 0.95 . The mean variation was -0.116 and the 95 % confidence interval -1.23 to 0.998 . The sensitivity of DCA 2000 was 91 % , and the specificity 94 % . DCA tended to underestimate HbAlc slightly as compared to HPLC . This study confirms the reliability of DCA 2000 for measuring glycated Hb . The system is easy to use and provides valuable information for the care of the diabetic patients BACKGROUND Glycosylated hemoglobin evaluation is very important for assessing the control of diabetes . Since the use of point-of-care ( POC ) devices for monitoring HbA1c is increasing , it is important to determine how these devices compare in relation to instrumentation used in the central laboratory ( CL ) . METHODS Eighty-eight r and omly selected sample s previously analyzed using the Bio-Rad Variant ™ II Hemoglobin Testing System were run on three POC Analyzers ( Siemens DCA Vantage ™ Analyzer , Axis-Shield Afinion ™ AS100 Analyzer , and Bio-Rad In2it ™ Analyzer ) . RESULTS All POC instruments showed good correlation to the CL method ( R(2)>0.95 for all methods ) . HbA1c levels obtained using Variant II ( mean=7.9 ; 95 % CI=7.5 - 8.3 % ) and In2it ( mean=7.9 ; 95 % C.I.=7.5 - 8.2 % ) instruments were found to have no statistical mean difference ( p=0.21 ) , while the values obtained using DCA Vantage ( mean=7.2 % C.I.=6.9 - 7.5 % ) and Afinion ( mean=7.3 % C.I.=7.0 - 7.6 % ) instruments were different ( p<0.001 ) from those of the CL method . The Afinion and DCA Vantage instruments increasingly underestimated the HbA1c compared to the CL as the HbA1c values increased . These differences were even more striking when the estimated average glucose is calculated . CONCLUSIONS Despite significant variation of results among the POC instruments evaluated relative to the CL method and pending resolution of HbA1c st and ardization issues , we conclude that all of the POC instruments can be used for HbA1c determination if clinicians are given instrument specific reference ranges Abstract Objective : To determine the relation between exposure to glycaemia over time and the risk of macrovascular or microvascular complications in patients with type 2 diabetes . Design : Prospect i ve observational study . Setting : 23 hospital based clinics in Engl and , Scotl and , and Northern Irel and . Participants : 4585 white , Asian Indian , and Afro-Caribbean UKPDS patients , whether r and omised or not to treatment , were included in analyses of incidence ; of these , 3642 were included in analyses of relative risk . Outcome measures : Primary predefined aggregate clinical outcomes : any end point or deaths related to diabetes and all cause mortality . Secondary aggregate outcomes : myocardial infa rct ion , stroke , amputation ( including death from peripheral vascular disease ) , and microvascular disease ( predominantly retinal photo-coagulation ) . Single end points : non-fatal heart failure and cataract extraction . Risk reduction associated with a 1 % reduction in up date d mean HbA1c adjusted for possible confounders at diagnosis of diabetes . Results : The incidence of clinical complications was significantly associated with glycaemia . Each 1 % reduction in up date d mean HbA1c was associated with reductions in risk of 21 % for any end point related to diabetes ( 95 % confidence interval 17 % to 24 % , P<0.0001 ) , 21 % for deaths related to diabetes ( 15 % to 27 % , P<0.0001 ) , 14 % for myocardial infa rct ion ( 8 % to 21 % , P<0.0001 ) , and 37 % for microvascular complications ( 33 % to 41 % , P<0.0001 ) . No threshold of risk was observed for any end point . Conclusions : In patients with type 2 diabetes the risk of diabetic complications was strongly associated with previous hyperglycaemia . Any reduction in HbA1c is likely to reduce the risk of complications , with the lowest risk being in those with HbA1c values in the normal range ( < 6.0 % ) OBJECTIVE Accurate and reliable HbA1c results can be obtained at the time of the office visit by using benchtop analyzers . We tested the hypothesis that immediately available HbA1c results could improve glycemic control by changing physician or patient behavior or both . RESEARCH DESIGN AND METHODS A r and omized controlled trial was conducted in 201 type 1 and insulin-treated type 2 diabetic patients attending an academic diabetes center . HbA1c levels , changes in insulin therapy , and use of health care re sources were assessed during a 12-month follow-up period . RESULTS HbA1c levels decreased significantly at 6 and 12 months in the immediate assay group ( -0.57 + /- 1.44 and -0.40 + /- 1.65 % , respectively ; P < 0.01 ) but did not change in the control group ( -0.11 + /- 0.79 and -0.19 + /- 1.16 % , respectively ; NS ) . The changes were similar for both type 1 and type 2 diabetic patients . There were no differences in the rates of hypoglycemic events or use of health care re sources . CONCLUSIONS In the setting of a controlled r and omized trial , the immediate feedback of HbA1c results at the time of patient encounters result ed in a significant improvement of glycemic control at 6-month follow-up and persisted for the 12-month study . The introduction of this assay was positively received by both patients and physicians Background : Glycohemoglobin A1c ( HbAlc ) is a universally accepted tool for glycemic control . Portable HbAlc devices for use in physicians ' offices are desirable because they provide immediate results that physicians can share with their patients . This has been shown to enhance self-management in patients with diabetes . We undertook this study to evaluate the accuracy and precision of a recently introduced device , the AlcNow ® InView ™ capillary monitor . Method : Previously tested EDTA-preserved whole blood sample s from our laboratory pool were preselected based on the results of HbAlc to cover a range from 4 to 13 % . HbAlc was then measured using an AlcNow InView capillary monitor . Blinded aliquots of these sample s were then sent to a National Glycohemoglobin St and ardization Program (NGSP)-certified reference laboratory for comparison . One sample with a laboratory HbAlc result of 9.2 % was measured with the InView device nine successive times to assess the device precision . The consistency between the measurement of HbAlc measured by the reference laboratory and the AlcNow InView device was analyzed via linear regression . Results : Thirty-five sample s were tested . The correlation between HbAlc measured by the InView device and the reference laboratory , as well as our own laboratory , was 0.96 . The coefficient of variation was 2.7l ° % . Conclusions : Results of this study confirm the accuracy and precision of the InView capillary HbAlc monitor . However , the feasibility , reproducibility , and cost-effectiveness of this promising device in the real-life setting s of physicians ' offices must be verified by prospect i ve clinical studies Background : The measurement of haemoglobin A1c(HbA1c ) by high-performance liquid chromatography ( HPLC ) is generally deemed unsuitable for point of care testing ( POCT ) due to its complexity and extended turnaround times ( TAT ) . The aim of this project was to evaluate two new HPLC instruments , the Bio-Rad D10 and the Primus PDQ , as POCT instruments compared with Bayer 's DCA2000 HbA1c immunoassay analyser in our paediatric diabetes clinic . Methods : A total of 228 sample s were analysed , of which 160 analyses were performed in our paediatric diabetes clinic . HbA1c results were compared by the Passing-Bablok agreement test , the Bl and -Altman difference analysis , within- and between-run imprecision , and TAT . Results : : The agreement test and difference analysis showed a correlation of r 2=0.96 and a mean HbA1c difference of < 0.1 % between the three analysers . The PDQ and the D10 achieved the within-run target coefficient of variation ( CV ) of < 2 % at an HbA1c of 7.5 % . Between-run imprecision at an HbA1c of 10.8 % produced CV of 3.5 % , 2.4 % and 1.6 % for the D10 , DCA2000 and PDQ , respectively . TAT studies confirmed that the PDQ was substantially faster than the DCA2000 and D10 . Conclusions : The PDQ had the shortest TAT , afforded r and om access and exhibited acceptable imprecision , and hence is the preferred instrument for our POCT environment Rapid in clinic measurement of glycated hemoglogin ( HbA1c ) allows to determine the level of metabolic control within a few minutes on capillary blood . We have evaluated the new DCA Vantage ( Siemens ) based on an immunological technique , replacing the DCA 2000 + ( Siemens ) . The study included 120 unselected young type 1 diabetic patients , with different degrees of metabolic control . The DCA Vantage was compared with the HPLC system ( Menarini HA 8160 ) whose deviation from the DCCT was < 0.1 % across the clinical range . The mean underestimation of the DCA Vantage was -0.40 % . The agreement limits ( + /- 1.96 SD ) were between 0.14 % and -0.93 % ; this means + /- 0.53 % around -0.40 % . In conclusion , the DCA Vantage underestimates HbA1c levels ; however it met the acceptance criteria of having a coefficient of variation < 3 % OBJECTIVE Failure to meet goals for glycemic control in primary care setting s may be due in part to lack of information critical to guide intensification of therapy . Our objective is to determine whether rapid-turnaround A1c availability would improve intensification of diabetes therapy and reduce A1c levels in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS In this prospect i ve controlled trial , A1c was determined on capillary glucose sample s and made available to providers , either during ( " rapid " ) or after ( " routine " ) the patient visit . Frequency of intensification of pharmacological diabetes therapy in inadequately controlled patients and A1c levels were assessed at baseline and after follow-up . RESULTS We recruited 597 subjects . Patients were 79 % female and 96 % African American , with average age of 61 years , duration of diabetes 10 years , BMI 33 kg/m(2 ) , and A1c 8.5 % . The rapid and routine groups had similar clinical demographics . Rapid A1c availability result ed in more frequent intensification of therapy when A1c was > /=7.0 % at the baseline visit ( 51 vs. 32 % of patients , P = 0.01 ) , particularly when A1c was > 8.0 % and /or r and om glucose was in the 8.4 - 14.4 mmol/l range ( 151 - 250 mg/dl ) . In 275 patients with two follow-up visits , A1c fell significantly in the rapid group ( from 8.4 to
Output:
| There was no difference in bias between clinical or laboratory operators in two devices .
Conclusions : This is the first meta- analysis to directly compare performance of POC HbA1c devices .
Use of a device with a mean negative bias compared to a laboratory method may lead to higher levels of glycemia and a lower risk of hypoglycaemia . |
MS213473 | ***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 Many authors have reported about the high prevalence rates of self-reported back pain in children . Nevertheless , little is known about the diagnosis of back disorders - regardless of whether the diagnosis is associated with back pain or not . Therefore , the aim of this study was to analyse the prevalence rates and costs of diagnosis of back disorders in childhood and youth . Methods We conducted a secondary data analysis of a large , population based German data set ( 2,300,980 insurants of statutory health insurance funds ) which allowed for identification of prevalence rates of diagnoses of back disorders in children ( age group 0 - 14 years ) and youths ( age group 15 - 24 years ) using three digit ICD-10 codes for dorsopathies ( M40 - M54 : kyphosis and lordosis ; scoliosis ; spinal osteochondrosis ; other deforming dorsopathies ; ankylosing spondylitis ; other inflammatory spondylopathies ; spondylosis ; other spondylopathies ; spondylopathies in diseases classified elsewhere ; cervical disc disorders ; other intervertebral disc disorders ; other dorsopathies , not elsewhere classified ; dorsalgia ) . Direct treatment costs were calculated based on the real incurred costs for cases with a singular diagnosis of a back disorder . Wherever possible , the results of the r and om sample were extrapolated to all insurants of statutory health insurance funds ( i. e. , about 90 % of the German population ) . Results We found prevalence rates for the diagnosis of back disorders to range between 0.01 - 12.5 % . " Scoliosis " ( M41 ) and " dorsalgia " ( M54 ) were the most frequent diagnoses in both age groups . Based on these results , it was calculated that in 2002 alone , approximately 1.4 million children/youths in Germany were diagnosed with " dorsalgia " ( M54 ) , and that the direct costs for back disorders in childhood and youth accounted for at least 100 million Euros . Conclusions Instead of focusing on the individual , and self-reported disorder or disability , this analysis allowed for the detailed evaluation of medical experts ' opinion on back disorders in childhood and youth and for a more objective or public health oriented insight in the topic of diagnosis of back pain and other back disorders . However , due to the method ological limitations by using ICD-10 coding , st and ardized r and om validity checks of population based data sets should be m and atory Within the scope of primary prevention regarding back functioning in children , research on the stability of intervention effects is indispensable . Along this line , the transition from childhood to adolescence is an important phase to evaluate the potential stability of intervention effects because of the typically mechanical and psychological dem and s related to adolescence . The main aim of the current study was to investigate the effects of a back education program at 2-year follow-up , in youngsters aged 13–14 years , on back posture knowledge , fear-avoidance beliefs and self-reported pain . An additional purpose was to evaluate which aspects of postural behavior were integrated in youngsters ’ lifestyles . At 2-year follow-up , the study sample included 94 secondary schoolchildren in the intervention group ( mean age 13.3 ± 0.8 years ) and 101 controls ( mean age 13.2 ± 0.7 years ) . The back posture program that had been implemented for two school years consisted of back education and the stimulation of postural dynamism in the class through support and environmental changes . A question naire was completed comparable to the pretest , posttest and follow-up evaluations . The current study demonstrated at 2-year follow-up stability of the improved general ( F = 1.590 , ns ) and specific ( F = 0.049 , ns ) back posture knowledge in children who had received early back posture education . Back posture education did not result in increased fear-avoidance beliefs ( F = 1.163 , ns ) or mounting back and /or neck pain reports ( F = 0.001 , ns ) . Based on self-reports for postural behavior , youngsters who had received the back posture program in the elementary school curriculum integrated crucial sitting and lifting principles conform to biomechanical favorable postural behavior . The steady intervention effects 2-year post-intervention demonstrated that intensive back posture education through the elementary school curriculum is effective till adolescence . Future research on the impact of early school-based back posture promotion in relation to the integration of back posture principles according to a biomechanical favorable lifestyle and back pain prevalence later in life is essential We tested the effects of implementing ergonomically design ed school furniture on measures of comfort , sitting posture and symptoms . Three classes of fourth grade rs ( 10 years old ) were r and omly assigned either to a control group using traditional furniture or to an experimental group which received the ergonomically design ed furniture . In both groups question naires were completed and sitting behaviour was observed twice before and after the intervention as well as at a five-month follow-up period . Although the experimental groups rated their furniture as being significantly more comfortable , differences in actual sitting behaviour were small . The experimental class experienced a reduction in musculoskeletal symptoms relative to the control group after implementing the ergonomically design ed furniture . Since pupils did not automatically sit ' properly ' in the ergonomic furniture , these results demonstrate the need for proper instructions and adjustment . Increased comfort and decreased symptoms may be used to motivate pupils to sit correctly . Our results suggest that furniture design is one aspect of a multidimensional problem Purpose Population based studies have demonstrated that children and adolescents often complain of low back pain . A group-r and omized controlled trial was carried out to investigate the effects of a postural education program on school backpack habits related to low back pain in children aged 10–12 year . Methods The study sample included 137 children aged 10.7 years ( SD = 0.672 ) . Six classes from two primary schools were r and omly allocated into experimental group ( EG ) ( N = 63 ) or control group ( CG ) ( N = 74 ) . The EG received a postural education program over 6 weeks consisting of six sessions , while the CG followed the usual school curriculum . A question naire was fulfilled by the participants at pre-test , post-test , and 3 months after the intervention finished . The outcomes collected were : ( 1 ) try to load the minimum weight possible , ( 2 ) carry school backpack on two shoulders , ( 3 ) belief that school backpack weight does not affect to the back , and ( 4 ) the use of locker or something similar at school . A sum score was computed from the four items . Results Single healthy items mostly improved after the intervention and remained improved after 3-month follow-up in EG , while no substantial changes were observed in the CG . Healthy backpack use habits score was significantly increased at post-test compared to baseline in the EG ( P < 0.000 ) , and remained significantly increased after 3-month , compared to baseline ( P = 0.001 ) . No significant changes were observed in the CG ( P > 0.2 ) . Conclusions The present study findings confirm that children are able to learn healthy backpack habits which might prevent future low back pain Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists PURPOSE The effect of education on proper wearing of a backpack was studied to determine whether or not a middle school population would improve posture during load carriage by maintaining a more natural posture and to determine if schoolchildren would comply with proper backpack wearing . METHOD 17 middle school children with a mean age of 12.7 years were r and omized into control and intervention groups . Participants were videotaped in four conditions from an anterior view and from a lateral view . Members of both groups participated in Sessions A and C , which consisted of videotaping of the four conditions . Intervention members additionally participated in Session B , consisting of education on how to wear a backpack properly . All participants were interviewed concerning their participation and its effect on how they wore their backpack . Video footage was analyzed to calculate the change in skeletal angles as a result of different methods of load carriage . Interview data was coded and analyzed . RESULTS No quantitative significance was found between control and intervention groups in regards to education on proper backpack wearing improving posture . Interviews revealed that intervention group members benefited from the education on proper wearing of a backpack . 87.5 % of the intervention group members proceeded to continue wearing the backpack properly after the education intervention . CONCLUSIONS Education regarding proper wearing of a backpack may impact the middle school aged child by improving quality of life as noted through decrease in reports of musculoskeletal pain by participants BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from " fair " to " substantial , " and the reliability of the total PEDro score was " fair " to " good . OBJECTIVES No previous r and omised controlled trials had been undertaken investigating the effect of school seating on back pain in 14 to 16 year olds . This study was design ed to test the effect of the use of a high-density foam wedge on normal school seating on the intensity of back pain . DESIGN R and omised controlled trial . SETTING Suffolk , a predominantly rural county in eastern Engl and . PARTICIPANTS One hundred and eighty-five students with back pain were recruited from 12 schools . R and omisation was stratified by school . The control and intervention groups included 92 and 83 students , respectively . INTERVENTION Following a 1-week baseline observation period , each student in the intervention group was given a wedge to use on their school chairs . OUTCOME MEASURE The primary outcome measure was pain intensity ( numerical rating scale , 0 to 10 ) recorded in pain diaries over 4 weeks . R and om effects models were used to analyse the pain intensity data . RESULTS Ninety-seven students ( 46 control group , 51 intervention group ) completed the trial . For the intervention group , pain intensity was reduced significantly over the 3 weeks of wedge use . The average reduction in pain intensity was estimated to be 0.709 points ( 95 % confidence interval 0.341 to 1.077 ) , representing a 58 % reduction in back pain for those in the intervention group . CONCLUSION Use of a wedge reduced the intensity of back pain significantly , especially in the evenings . The results suggest that further research into the longer-term effect of seating on pain intensity in adolescents should be considered QUESTION Does an eight-week exercise program reduce the intensity and prevalence of low back pain in 12 - 13 year old children ? Does it decrease the childhood physical risk factors for low back pain and promote a sense of well-being ? DESIGN R and omised trial with concealed allocation and assessor blinding . PARTICIPANTS Seventy-two 12 - 13 year old children , who had complained of low back pain in the past three months . INTERVENTION The experimental group completed eight exercise classes of 40 - 45 minutes duration over eight weeks conducted by a physiotherapist , whilst the control group received no intervention . OUTCOME MEASURES The primary outcome was pain intensity measured on a 10-cm visual analogue scale . Secondary outcomes included 3-month prevalence of pain , childhood physical risk factors for low back pain , and sense of well-being . Measures were taken at baseline ( Month 0 ) , post-intervention ( Month 3 ) , and three months later ( Month 6 ) . RESULTS Pain intensity over the past month had decreased by 2.2 cm ( 95 % CI 1.0 to 3.5 ) more for the experimental group than the control group at Month 3 and was still 2.0 cm
Output:
| For the prevention of LBP , there was moderate quality evidence to suggest back education and promotion programs are not effective in reducing LBP prevalence in children and adolescents . |
MS213474 | ***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 safety and efficacy of combining artemether ( AM ) and praziquantel ( PZQ ) in different regimens for treating acute schistosomiasis japonica . METHODS We undertook a r and omized , double-blind , placebo-controlled trial within four specialized schistosomiasis hospitals in the Dongting Lake region , Hunan province , China , between May 2003 and December 2005 . Study participants were r and omized into one of four treatment regimes : group A received 60 mg/kg PZQ + 6 mg/kg AM ; group B received 60 mg/kg PZQ + AM placebo ; group C received 120 mg/kg PZQ + 6 mg/kg AM ; and group D received 120 mg/kg PZQ + AM placebo . All participants were followed up over a 45-day period . The primary endpoint of the trial was human infection status ( determined by positive stool examination ) . Secondary endpoints involved clinical observations and blood biochemistry , including monitoring haemoglobin and alanine aminotransferase levels over time . FINDINGS Treatment efficacies of the four different treatment regimens were 98.0 % , 96.4 % , 97.7 % and 95.7 % for group A , B , C , and D respectively ( P > 0.05 ) . The group B had a greater treatment efficacy ( 96.4 % ) than the group D ( 95.7 % ) ( P > 0.05 ) . Group A treatment was better for clearance of fever ( P < 0.05 ) and result ed in a shorter hospitalization time ( P < 0.05 ) . CONCLUSION This is the first report of a r and omized , double-blind , placebo-controlled trial for evaluating combined chemotherapy with AM and two different dosages ( 60 mg/kg and 120 mg/kg ) of PZQ in the treatment of acute schistosomiasis japonica in China . The combination of AM and PZQ chemotherapy did not improve treatment efficacy compared with PZQ alone . PZQ given as a dosage of 60 mg/kg ( 1 day , 3 x 20 mg/kg doses at 4 - 5 hour intervals ) may be as effective as a dosage of 120 mg/kg ( 6 days , 20 mg/kg for each day split into 3 doses at 4 - 5 hour intervals ) Background This study was conducted to determine the efficacy of the antimalarial artemisinin-based combination therapy ( ACT ) artesunate + sulfamethoxypyrazine/pyrimethamine ( As+SMP ) , administered in doses used for malaria , to treat Schistosoma haematobium in school aged children . Methodology /Principal Findings The study was conducted in Djalakorodji , a peri-urban area of Bamako , Mali , using a double blind setup in which As+SMP was compared with praziquantel ( PZQ ) . Urine sample s were examined for Schistosoma haematobium on days −1 , 0 , 28 and 29 . Detection of haematuria , and haematological and biochemical exams were conducted on day 0 and day 28 . Clinical exams were performed on days 0 , 1 , 2 , and 28 . A total of 800 children were included in the trial . The cure rate obtained without viability testing was 43.9 % in the As+SMP group versus 53 % in the PZQ group ( Chi2 = 6.44 , p = 0.011 ) . Egg reduction rates were 95.6 % with PZQ in comparison with 92.8 % with As+SMP , p = 0.096 . The proportion of participants who experienced adverse events related to the medication was 0.5 % ( 2/400 ) in As+SMP treated children compared to 2.3 % ( 9/399 ) in the PZQ group ( p = 0.033 ) . Abdominal pain and vomiting were the most frequent adverse events in both treatment arms . All adverse events were categorized as mild . Conclusions / Significance The study demonstrates that PZQ was more effective than As+SMP for treating Schistosoma haematobium . However , the safety and tolerability profile of As+SMP was similar to that seen with PZQ . Our findings suggest that further investigations seem justifiable to determine the dose/efficacy/safety pattern of As+SMP in the treatment of Schistosoma infections . Trial Registration Clinical Trials.gov BACKGROUND Schistosomiasis is an important parasitic disease in Kenya . Decreasing susceptibility of schistosomes to praziquantel , the major drug used to reduce disease morbidity , has made assessment of new antischistosomal drugs a priority . We aim ed to assess the safety and efficacy of an artesunate-based combination drug in the treatment of schistosomiasis . METHODS In this open-label r and omised trial in Rarieda district of western Kenya , we enrolled school children ( aged 6 - 15 years ) who had Schistosoma mansoni infection according to duplicate Kato-Katz thick smears from a stool sample . Computer-generated block r and omisation was used to assign children ( 1:1 ) to receive artesunate ( 100 mg ) with sulfalene ( also known as sulfamethoxypyrazine ; 250 mg ) plus pyrimethamine ( 12.5 mg ) as one dose every 24 h for 3 days or one dose of praziquantel ( 40 mg/kg per day ) . The primary efficacy endpoint was the number of participants cured 28 days after treatment . Analysis was by intention to treat . This trial is registered with Clinical Trials.gov , number NCT01054651 . RESULTS Between October and December , 2009 , 212 children were enrolled and assigned to receive artesunate with sulfalene plus pyrimethamine ( n=106 ) or praziquantel ( n=106 ) . 69 patients ( 65 % ) were cured in the praziquantel treatment group compared with 15 ( 14 % ) in the artesunate with sulfalene plus pyrimethamine treatment group ( p<0.0001 ) . Adverse events were less common in patients taking artesunate with sulfalene plus pyrimethamine than in those taking praziquantel ( 22 % [ n=23 ] vs 49 % [ n=52 ] , p<0.0001 ) , and no drug-related serious adverse events occurred . INTERPRETATION The st and ard treatment with praziquantel is more effective than artesunate with sulfalene plus pyrimethamine in the treatment of children with S mansoni infection in western Kenya . Whether artemisinin-based combination therapy has a role in the treatment of schistosomiasis is unclear Artemether is an efficacious antimalarial drug that also displays antischistosomal properties . Laboratory studies have found that artemether curtails the development of adult worms of Schistosoma japonicum , S. mansoni and S. haematobium , and thus prevents morbidity . These findings have been confirmed in clinical trials for the former two parasites ; administered orally once every 2 - 3 weeks , artemether significantly reduced the incidence and intensity of patent infections . Here , we present the first r and omized , double-blind , placebo-controlled trial of artemether against S. haematobium , done in a highly endemic area of Côte d'Ivoire . Urine specimens from 440 schoolchildren were examined over 4 consecutive days , followed by two systematic praziquantel treatments 4 weeks apart . S. haematobium-negative children were r and omized to receive 6 mg/kg artemether ( N = 161 ) or placebo ( N = 161 ) . Medication was administered orally for a total of six doses once every 4 weeks . Adverse events were assessed 72 hours after medication , and perceived illness episodes were monitored throughout the study period . Incidence and intensity of S. haematobium infections , and microhematuria and macrohematuria were assessed 3 weeks after the final dosing . We also monitored malaria parasitemia and treated positive cases with sulfadoxine-pyrimethamine ( SP ) . Oral artemether was well tolerated . The incidence of patent S. haematobium infections in artemether recipients was significantly lower than in placebo recipients ( 49 % versus 65 % , protective efficacy : 0.25 , 95 % CI : 0.08 - 0.38 , P = 0.007 ) . The geometric mean infection intensity in the artemether group was less than half that of the placebo recipients ( 3.4 versus 7.4 eggs/10 mL urine , P < 0.001 ) . Heavy S. haematobium infections , microhematuria and macrohematuria , and the incidence of malaria parasitemia were all significantly lower in artemether recipients . In conclusion , previous findings of efficacy of artemether against S. japonicum and S. mansoni were confirmed for S. haematobium , although the protective efficacy was considerably lower . These findings enlarge the scope and potential of artemether and further contribute to discussion s of its role as an additional tool for integrated schistosomiasis control Recently , artemisinin derivatives have been shown to be efficacious in chemoprophylaxis of and chemotherapy for Schistosoma japonicum and S. mansoni infections . Therefore , a double-blind , r and omized , placebo-controlled study was carried out to investigate the efficacy and tolerability of artesunate plus placebo and the combination of artesunate and praziquantel in the treatment of S. haematobium infections in Gabon . The 300 infected schoolchildren included in the study were r and omized to receive artesunate plus placebo ( n=90 ) , praziquantel plus placebo ( n=90 ) , artesunate and praziquantel ( n=90 ) , or only placebo ( n=30 ) . End points were efficacy , assessed as cure on day 56 , and tolerability . All treatment regimens were well tolerated . The praziquantel plus placebo-treated group attained a cure rate of 73 % , artesunate plus placebo a rate of 27 % , the combination of artesunate and praziquantel a rate of 81 % , and placebo alone a rate of 20 % . In summary , earlier findings of efficacy of artemisinin derivitives against S. mansoni and S. japonicum could not be confirmed in S. haematobium infections OBJECTIVE To study the preventive effect of oral artemether ( Art ) against schistosomal infection in the field . METHODS In Minglang District of Yiyang City , Hunan Province , there is an islet with embankment type endemic area in the southern Dongting Lake region . From August to October 1994 the residents who frequently contacted the infested water were selected for study and allocated to the Art group and the control group . About one month before the preventive Art administration , all the residents understudied were examined by stool hatching technique , and then treated orally with praziquantel at a single dose of 40 mg/kg in stool egg-negative residents and 50 mg/kg in stool egg-positive ones . In the Art group , the first dose of 6 mg/kg was given at the end of August , followed by 3 repeated doses every 15 days . Placebo ( starch ) was given to the control group at the same time as in the Art group . The preventive efficacy was evaluated by stool examination 25 - 32 days after the last medication . RESULTS In the Art group , 20 out of 365 studied residents became stool positive with an infection rate of 5.5 % , while in the control group , 51 out of 376 studied residents were stool positive with an infection rate of 13.6 % . The egg count per gram of feces ( EPG ) determined by the Kato-Katz method was 122 + /- 79 in the Art group and 681 + /- 909 in the control group . Meanwhile , two cases of acute schistosomiasis were found in the control group , but none was observed in the Art group . No apparent adverse side effect was seen during the treatment with Art . CONCLUSION Oral Art exhibited apparent preventive effect on the residents who contacted the infested water in schistosomiasis endemic area OBJECTIVE To study the preventive effect of artemether ( Art ) in protecting the people from schistosome infection during flood fighting in schistosomiasis endemic area of Poyang Lake , Jiangxi Province . METHODS From mid July to mid August in 1996 , the water level in Poyang Lake rose due to torrential rains and 2 embankments , Zhedi and Jiangtongdi , which appeared in dangerous situation and were selected as the pilot spots . After those who went to fight against flood arrived at the pilots their sera were collected within 48 hours and were examined with indirect hemagglutination test ( IHA ) , enzyme-linked immunosorbent assay ( ELISA ) and McAb-ELISA . Individuals with negative outcome in the 3 tests were then selected as the study subjects and were allocated r and omly to the Art or the control group . The first dose of Art given to the individuals contacted with the infested water within 11 - 15 days was 6 mg/kg . If the individual continually contacted the infested water , the same dose of Art was given once every 15 days . After the individuals withdrew from the pilot , one more dose of
Output:
| / SIGNIFICANCE This meta- analysis confirms that artemisinin derivatives used in combination with praziquantel have the potential to increase the cure rates in schistosomiasis treatment , but not artesunate alone .
It is also confirmed that repeated doses of artemisinin derivatives play a prophylactic role , significantly reducing the incidence of Schistosoma japonicum infections compared with placebo |
MS213475 | ***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 We aim ed to improve the quality and safety of h and over of patients from surgery to intensive care using the analogy of a Formula 1 pit stop and expertise from aviation . METHODS A prospect i ve intervention study measured the change in performance before and after the implementation of a new h and over protocol that was developed through detailed discussion s with a Formula 1 racing team and aviation training captains . Fifty ( 23 before and 27 after ) postsurgery patient h and overs were observed . Technical errors and information omissions were measured using checklists , and teamwork was scored using a Likert scale . Duration of the h and over was also measured . RESULTS The mean number of technical errors was reduced from 5.42 ( 95 % CI + /-1.24 ) to 3.15 ( 95 % CI + /-0.71 ) , the mean number of information h and over omissions was reduced from 2.09 ( 95 % CI + /-1.14 ) to 1.07 ( 95 % CI + /-0.55 ) , and duration of h and over was reduced from 10.8 min ( 95 % CI + /-1.6 ) to 9.4 min ( 95 % CI + /-1.29 ) . Nine out of twenty-three ( 39 % ) precondition patients had more than one error in both technical and information h and over prior to the new protocol , compared with three out of twnety-seven ( 11.5 % ) with the new h and over . Regression analysis showed that the number of technical errors were significantly reduced with the new h and over ( t = -3.63 , P < 0.001 ) , and an interaction suggested that teamwork ( t = 3.04 , P = 0.004 ) had a different effect with the new h and over protocol . CONCLUSIONS The introduction of the new h and over protocol lead to improvements in all aspects of the h and over . Expertise from other industries can be extrapolated to improve patient safety , and in particular , areas of medicine involving the h and over of patients or information Objective To assess the frequency and nature of adverse events to patients in selected hospitals in developing or transitional economies . Design Retrospective medical record review of hospital admissions during 2005 in eight countries . Setting Ministries of Health of Egypt , Jordan , Kenya , Morocco , Tunisia , Sudan , South Africa and Yemen ; the World Health Organisation ( WHO ) Eastern Mediterranean and African Regions ( EMRO and AFRO ) , and WHO Patient Safety . Participants Convenience sample of 26 hospitals from which 15 548 patient records were r and omly sample d. Main outcome measures Two stage screening . Initial screening based on 18 explicit criteria . Records that screened positive were then review ed by a senior physician for determination of adverse event , its preventability , and the result ing disability . Results Of the 15 548 records review ed , 8.2 % showed at least one adverse event , with a range of 2.5 % to 18.4 % per country . Of these events , 83 % were judged to be preventable , while about 30 % were associated with death of the patient . About 34 % adverse events were from therapeutic errors in relatively non-complex clinical situations . Inadequate training and supervision of clinical staff or the failure to follow policies or protocol s contributed to most events . Conclusions Unsafe patient care represents a serious and considerable danger to patients in the hospitals that were studied , and hence should be a high priority public health problem . Many other developing and transitional economies will probably share similar rates of harm and similar contributory factors . The convenience sampling of hospitals might limit the interpretation of results , but the identified adverse event rates show an estimate that should stimulate and facilitate the urgent institution of appropriate remedial action and also to trigger more research . Prevention of these adverse events will be complex and involves improving basic clinical processes and does not simply depend on the provision of more re sources BACKGROUND Surgery has become an integral part of global health care , with an estimated 234 million operations performed yearly . Surgical complications are common and often preventable . We hypothesized that a program to implement a 19-item surgical safety checklist design ed to improve team communication and consistency of care would reduce complications and deaths associated with surgery . METHODS Between October 2007 and September 2008 , eight hospitals in eight cities ( Toronto , Canada ; New Delhi , India ; Amman , Jordan ; Auckl and , New Zeal and ; Manila , Philippines ; Ifakara , Tanzania ; London , Engl and ; and Seattle , WA ) representing a variety of economic circumstances and diverse population s of patients participated in the World Health Organization 's Safe Surgery Saves Lives program . We prospect ively collected data on clinical processes and outcomes from 3733 consecutively enrolled patients 16 years of age or older who were undergoing noncardiac surgery . We subsequently collected data on 3955 consecutively enrolled patients after the introduction of the Surgical Safety Checklist . The primary end point was the rate of complications , including death , during hospitalization within the first 30 days after the operation . RESULTS The rate of death was 1.5 % before the checklist was introduced and declined to 0.8 % afterward ( P=0.003 ) . Inpatient complications occurred in 11.0 % of patients at baseline and in 7.0 % after introduction of the checklist ( P<0.001 ) . CONCLUSIONS Implementation of the checklist was associated with concomitant reductions in the rates of death and complications among patients at least 16 years of age who were undergoing noncardiac surgery in a diverse group of hospitals Objective Implementation of a surgical checklist depends on many organisational factors and on socio-cultural patterns . The objective of this study was to identify barriers to effective implementation of a surgical checklist and to develop a best use strategy . Setting 18 cancer centres in France . Design The authors first assessed use compliance and completeness rates of the surgical checklist on a r and om sample of 80 surgical procedures performed under general or loco-regional anaesthesia in each of the 18 centres . They then developed a typology of the organisational and cultural barriers to effective checklist implementation and defined each barrier 's contents using data from collective and semi-structured individual interviews of key staff , the results of an email question naire sent to the 18 centres , and direct observations over 20 h in two centres . Results The study consisted of 1440 surgical procedures , 1299 checklists , and 28 578 items . The mean compliance rate was 90.2 % ( 0 , 100 ) . The mean completion rate was 61 % ( 0 , 84 ) . 11 barriers to effective checklist implementation were identified . Their incidence varied widely across centres . The main barriers were duplication of items within existing checklists ( 16/18 centres ) , poor communication between surgeon and anaesthetist ( 10/18 ) , time spent completing the checklist for no perceived benefit , and lack of underst and ing and timing of item checks ( 9/18 ) , ambiguity ( 8/18 ) , unaccounted risks ( 7/18 ) and a time-honoured hierarchy ( 6/18 ) . Conclusions Several of the barriers to the successful implementation of the surgical checklist depended on organisational and cultural factors within each centre . The authors propose a strategy for change for checklist design , use and assessment , which could be used to construct a feedback loop for local team organisation and national initiatives Objective : To assess whether implementation of a 19-item World Health Organization ( WHO ) Surgical Safety Checklist in urgent surgical cases would improve compliance with basic st and ards of care and reduce rates of deaths and complications . Background : Use of the WHO Surgical Safety Checklist has been shown to be associated with significant reductions in complications and deaths . Before evaluation of this safety tool , concern was raised about whether its use would be practical or beneficial during urgent surgical procedures . Methods : We prospect ively collected clinical process and outcome data for 1750 consecutively enrolled patients 16 years of age or older undergoing urgent noncardiac surgery before and after introduction of the WHO Surgical Safety Checklist in 8 diverse hospitals around the world ; 842 underwent urgent surgery — defined as an operation required within 24 hours of assessment to be beneficial — before introduction of the checklist and 908 after introduction of the checklist . The primary end point was the rate of complications , including death , during hospitalization up to 30 days following surgery . Results : The complication rate was 18.4 % ( n = 151 ) at baseline and 11.7 % ( n = 102 ) after the checklist was introduced ( P = 0.0001 ) . Death rates dropped from 3.7 % to 1.4 % following checklist introduction ( P = 0.0067 ) . Adherence to 6 measured safety steps improved from 18.6 % to 50.7 % ( P < 0.0001 ) . Conclusions : Implementation of the checklist was associated with a greater than one-third reduction in complications among adult patients undergoing urgent noncardiac surgery in a diverse group of hospitals . Use of the WHO Surgical Safety Checklist in urgent operations is feasible and should be considered Background Positive changes in safety culture have been hypothesized to be one of the mechanisms behind the reduction in mortality and morbidity after the introduction of the World Health Organization 's Surgical Safety Checklist ( SSC ) . We aim ed to study the checklist effects on safety culture perceptions in operating theatre personnel using a prospect i ve controlled intervention design at a single Norwegian university hospital . Methods We conducted a study with pre- and post-intervention surveys using the intervention and control groups . The primary outcome was the effects of the Norwegian version of the SSC on safety culture perceptions . Safety culture was measured using the vali date d Norwegian version of the Hospital Survey on Patient Safety Culture . Descriptive characteristics of operating theatre personnel and checklist compliance data were also recorded . A mixed linear regression model was used to assess changes in safety culture . Results The response rate was 61 % ( 349/575 ) at baseline and 51 % ( 292/569 ) post-intervention . Checklist compliance ranged from 77 % to 85 % . We found significant positive changes in the checklist intervention group for the culture factors ‘ frequency of events reported ’ and ‘ adequate staffing ’ with regression coefficients at −0.25 [ 95 % confidence interval ( CI ) , −0.47 to −0.07 ] and 0.21 ( 95 % CI , 0.07–0.35 ) , respectively . Overall , the intervention group reported significantly more positive culture scores — including at baseline . Conclusions Implementation of the SSC had rather limited impact on the safety culture within this hospital BACKGROUND Preventable deaths due to errors in trauma patients with otherwise survivable injuries account for up to 10 % of fatalities in Level I trauma centers , 50 % of these errors occur in the intensive care unit ( ICU ) . The root cause of 67 % of the Joint Commission sentinel events is communication errors . The objective is ( 1 ) to study how critical information de grade s and how it is lost over 24 hours and ( 2 ) to determine whether a structured checklist for ICU h and offs prevents information loss . METHODS Prospect i ve cohort study of trauma and surgical ICU teams observed with and without use of the checklist . An observational period ( control group ) was followed by a didactic session on the science and use of a checklist ( study group ) , which was used for patient management and h and offs . Information was tracked for a 24-hour period and all h and offs . Comparisons use chi or Fisher 's exact test and a p value < 0.05 was defined as significant . RESULTS Three hundred and thirty-two patient ICU days were observed ( 119 control , 213 study ) and 689 patient care items ( 303 control , 386 study ) were followed . Seventy-five ( 10.9 % ) items were lost over 24 hours ; 61 of 303 ( 20.1 % ) without checklist and 14 of 386 ( 3.6 % ) with checklist ( p < 0.0001 ) . Critical laboratory values and test results were the most frequent lost items ( 36.1 % control vs. 4.5 % study p < 0.0001 ) . Six of 75 ( 8.1 % ) items were correctly ordered but not carried out by ICU nursing staff -- all caught and corrected with checklist use . CONCLUSION Critical information is de grade d over 24 hours in the ICU . A structured checklist significantly reduces patient errors due to lost information and communication lapses between trauma ICU team members at h and offs of care OBJECTIVES Perioperative h and offs are a particularly high-risk period given patients ' postprocedural physiology , their physical transport through the hospital , and the triad transfer of personnel , information , and technology . The authors piloted a new perioperative h and off process to guide patient transfers from the cardiac operating room ( OR ) to the cardiac surgical intensive care unit ( CSICU ) . The aim of the study was to evaluate the impact of a st and ardized h and off process on patient care and provider satisfaction . DESIGN A prospect i ve , unblinded intervention study . SETTING A CSICU in a teaching hospital . PARTICIPANTS Two hundred thirty-eight health care practitioners during the transfer of care of 60 patients . INTERVENTIONS The implementation of a st and ardized h and off protocol and checklist . MEASUREMENTS AND MAIN RESULTS After the protocol 's implementation , the presence of all h and off core team members at the bedside increased from 0 % at baseline to 68 % after intervention . The percentage of missed information in the surgery report decreased from 26 % to 16 % ( p = 0.03 ) , but the percentage of missed information in the anesthesia report showed no significant change (
Output:
| The main findings were improved communication , reduced adverse events , better adherence to st and ard operating procedures , and reduced morbidity and mortality .
None of the included studies reported decreased patient safety or quality after introducing safety checklists .
CONCLUSION Safety checklists appear to be effective tools for improving patient safety in various clinical setting s by strengthening compliance with guidelines , improving human factors , reducing the incidence of adverse events , and decreasing mortality and morbidity .
None of the included studies reported negative effects on safety |
MS213476 | ***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: IMPORTANCE Although many patients with end-stage cancer are offered chemotherapy to improve quality of life ( QOL ) , the association between chemotherapy and QOL amid progressive metastatic disease has not been well-studied . American Society for Clinical Oncology guidelines recommend palliative chemotherapy only for solid tumor patients with good performance status . OBJECTIVE To evaluate the association between chemotherapy use and QOL near death ( QOD ) as a function of patients ' performance status . DESIGN , SETTING , AND PARTICIPANTS A multi-institutional , longitudinal cohort study of patients with end-stage cancer recruited between September 2002 and February 2008 . Chemotherapy use ( n = 158 [ 50.6 % ] ) and Eastern Cooperative Oncology Group ( ECOG ) performance status were assessed at baseline ( median = 3.8 months before death ) and patients with progressive metastatic cancer ( N = 312 ) following at least 1 chemotherapy regimen were followed prospect ively until death at 6 outpatient oncology clinics in the United States . MAIN OUTCOMES AND MEASURES Patient QOD was determined using vali date d caregiver ratings of patients ' physical and mental distress in their final week . RESULTS Chemotherapy use was not associated with patient survival controlling for clinical setting and patients ' performance status . Among patients with good ( ECOG score = 1 ) baseline performance status , chemotherapy use compared with nonuse was associated with worse QOD ( odds ratio [ OR ] , 0.35 ; 95 % CI , 0.17 - 0.75 ; P = .01 ) . Baseline chemotherapy use was not associated with QOD among patients with moderate ( ECOG score = 2 ) baseline performance status ( OR , 1.06 ; 95 % CI , 0.51 - 2.21 ; P = .87 ) or poor ( ECOG score = 3 ) baseline performance status ( OR , 1.34 ; 95 % CI , 0.46 - 3.89 ; P = .59 ) . CONCLUSIONS AND RELEVANCE Although palliative chemotherapy is used to improve QOL for patients with end-stage cancer , its use did not improve QOD for patients with moderate or poor performance status and worsened QOD for patients with good performance status . The QOD in patients with end-stage cancer is not improved , and can be harmed , by chemotherapy use near death , even in patients with good performance status A self-control , r and omized , and open-label clinical trial was performed to test the effects of the unicellular green algae Chlorella and hot water extract supplementation on quality of life ( QOL ) in patients with breast cancer . Forty-five female patients with breast cancer who were living at home and not hospitalized were r and omly assigned to 3 groups receiving vitamin mix tablet ( control ) , Chlorella granules ( test food-1 ) , or Chlorella extract drink ( test food-2 ) daily for one month . The Functional Assessment of Cancer Therapy-Breast ( FACT-B ) , the Izumo scale for abdominal symptom-specific QOL , and a narrative-form question naire were used to determine outcomes . Data of thirty-six subjects were included for final analysis . FACT-B scores at presupplementation found no significant group differences in all subscales . Scores on the breast cancer subscale in the Chlorella granule group significantly increased during the supplementation period ( P = 0.042 ) . Fifty percent of the Chlorella extract group reported positive effects by the test food such as reduction of fatigue and improvements of dry skin ( P < 0.01 versus control group ) . The findings suggested the beneficial effects of Chlorella on breast cancer-related QOL and of Chlorella extract on vitality status in breast cancer patients . These findings need to be confirmed in a larger study Ginger supplementation could be an effective adjuvant treatment for chemotherapy-induced nausea ( CIN ) . The aim of this clinical trial was to address significant method ological limitations in previous trials . Patients ( N = 51 ) were r and omly allocated to receive either 1.2 g of st and ardised ginger extract or placebo per day , in addition to st and ard anti-emetic therapy , during the first three cycles of chemotherapy . The primary outcome was CIN-related quality of life ( QoL ) measured with the Functional Living Index- Emesis ( FLIE ) question naire . Secondary outcomes included acute and delayed nausea , vomiting , and retching as well as cancer-related fatigue , nutritional status , and CIN and vomiting-specific prognostic factors . Over three consecutive chemotherapy cycles , nausea was more prevalent than vomiting ( 47 % vs. 12 % ) . In chemotherapy Cycle 1 , intervention participants reported significantly better QoL related to CIN ( p = 0.029 ) , chemotherapy-induced nausea and vomiting (CINV)-related QoL ( p = 0.043 ) , global QoL ( p = 0.015 ) and less fatigue ( p = 0.006 ) than placebo participants . There were no significant results in Cycle 2 . In Cycle 3 , global QoL ( p = 0.040 ) and fatigue ( p = 0.013 ) were significantly better in the intervention group compared to placebo . This trial suggests adjuvant ginger supplementation is associated with better chemotherapy-induced nausea-related quality of life and less cancer-related fatigue , with no difference in adverse effects compared to placebo Purpose Aromatase inhibitor (AI)-induced joint symptoms negatively impact drug adherence and quality of life in breast cancer survivors . Mechanisms underlying symptoms may include inflammation . It is hypothesized that n − 3 polyunsaturated fatty acids ( PUFAs ) have anti-inflammatory properties and may reduce symptoms . Methods We conducted a r and omized , double-blind , placebo-controlled study comparing 4.3 g/day n − 3 PUFA supplements vs placebo for 24 weeks in postmenopausal breast cancer patients starting adjuvant AIs . Primary endpoints were adherence and tolerability ; secondary outcomes included inflammatory cytokines and symptoms assessed by the Brief Pain Inventory short form ( BPI-SF ) and Functional Assessment of Cancer Treatment-Endocrine Symptoms ( FACT-ES ) at 0 , 12 , and 24 weeks . Results Forty-four women were r and omized , of which 35 completed the study . Adherence was ≥ 88 % based on these 35 patients with pill counts as well as change in red blood cell ( RBC ) n − 3 PUFAs . Common toxicities included grade 1 flatulence ( 55 % of both groups ) and belching ( 45 % of n − 3 group ) . Mean pain severity scores ( BPI-SF ) did not change significantly by time or treatment arm . Quality of life , based on FACT-ES scores , significantly decreased within placebo ( p = 0.04 ) , but not the n − 3 group ( p = 0.58 ) , with a trend toward between-group differences ( p = 0.06 ) at 12 weeks , but no significant differences at 24 weeks . RBC n − 3 levels were strongly positively correlated with FACT-ES at 12 weeks , but attenuated at 24 weeks . Conclusion High-dose n − 3 PUFA supplementation is feasible and well tolerated when administered with AIs . Additional studies are needed to evaluate efficacy in prevention of joint symptoms PURPOSE A r and omized phase II study was performed to measure the potential therapeutic effects of yoga on fatigue , erectile dysfunction , urinary incontinence , and overall quality of life ( QOL ) in prostate cancer ( PCa ) patients undergoing external beam radiation therapy ( RT ) . METHODS AND MATERIAL S The participants were r and omized to yoga and no-yoga cohorts ( 1:1 ) . Twice-weekly yoga interventions were offered throughout the 6- to 9-week courses of RT . Comparisons of st and ardized assessment s were performed between the 2 cohorts for the primary endpoint of fatigue and the secondary endpoints of erectile dysfunction , urinary incontinence , and QOL before , during , and after RT . RESULTS From October 2014 to January 2016 , 68 eligible PCa patients underwent informed consent and agreed to participate in the study . Of the 68 patients , 18 withdrew early , mostly because of treatment schedule-related time constraints , result ing in 22 and 28 patients in the yoga and no-yoga groups , respectively . Throughout treatment , those in the yoga arm reported less fatigue than those in the control arm , with global fatigue , effect of fatigue , and severity of fatigue subscales showing statistically significant interactions ( P<.0001 ) . The sexual health scores ( International Index of Erectile Function Question naire ) also displayed a statistically significant interaction ( P=.0333 ) . The International Prostate Symptom Score revealed a statistically significant effect of time ( P<.0001 ) but no significant effect of treatment ( P=.1022 ) . The QOL measures had mixed results , with yoga having a significant time by treatment effect on the emotional , physical , and social scores but not on functional scores . CONCLUSIONS A structured yoga intervention of twice-weekly classes during a course of RT was associated with a significant reduction in pre-existing and RT-related fatigue and urinary and sexual dysfunction in PCa patients OBJECTIVE Although chemotherapy-induced cognitive impairment is common among breast cancer patients , evidence for effective interventions addressing cognitive deficits is limited . This r and omized controlled trial examined the feasibility and preliminary efficacy of a Tibetan Sound Meditation ( TSM ) program to improve cognitive function and quality of life in breast cancer patients . METHODS Forty-seven breast cancer patients ( mean age 56.3 years ) , who were staged I-III at diagnosis , 6 - 60 months post-chemotherapy , and reported cognitive impairment at study entry were recruited . Participants were r and omized to either two weekly TSM sessions for 6 weeks or a wait list control group . Neuropsychological assessment s were completed at baseline and 1 month post-treatment . Self-report measures of cognitive function ( Functional Assessment of Cancer Therapy (FACT)-Cog ) , quality of life ( SF-36 ) , depressive symptoms ( Center for Epidemiologic Studies Depression Scale ) , sleep disturbance ( Pittsburgh Sleep Quality Index ) , fatigue ( Brief Fatigue Inventory ) , and spirituality ( FACT-Sp ) were completed at baseline , the end of treatment , and 1 month later . RESULTS Relative to the control group , women in the TSM group performed better on the verbal memory test ( Rey Auditory Verbal Learning Test trial 1 ) ( p = 0.06 ) and the short-term memory and processing speed task ( Digit Symbol ) ( p = 0.09 ) and reported improved cognitive function ( p = 0.06 ) , cognitive abilities ( p = 0.08 ) , mental health ( p = 0.04 ) , and spirituality ( p = 0.05 ) at the end of treatment but not 1 month later . CONCLUSIONS This r and omized controlled trial revealed that TSM program appears to be a feasible and acceptable intervention and may be associated with short-term improvements in objective and subjective cognitive function as well as mental health and spirituality in breast cancer patients Purpose This study was to evaluate the efficacy of a complementary Chinese treatment modality Guolin-Qigong ( GLQG ) for patients with breast cancer on the body-mind health . Methods A r and omized controlled clinical trial was conducted among 158 women with breast cancer . Subjects were r and omized to receive GLQG ( test group ) versus a physical stretching program ( control group ) following conventional treatment for breast cancer . GLQG and stretching interventions were performed twice a week over 24 weeks . The primary outcome was the change in quality of life ( QoL ) . Secondary outcome measures included anxiety , depression , and clinical indicators . All participants were assessed at four time-points , at the beginning of the study ( T1 ) , after 12 weeks of the intervention ( T2 ) , immediately after 24-week intervention ( T3 ) , and at 48-week follow-up visit ( T4 ) . Results Improvements in QoL were evident in both groups but the test group fared better than the control group at the 12th week ( P < 0.01 ) and particularly in emotional well-being ( P < 0.01 ) and breast cancer-specific well-being ( P < 0.001 ) . The test group showed an improvement in anxiety levels ( P < 0.01 ) , whereas the control group showed improvements in depression ( P < 0.05 ) but there was no significant difference between groups ( P > 0.05 ) . Both groups showed improvements in immunological function and the test group fared better than the control in TNF-α levels ( P < 0.05 ) . The results in subjects who practice d more than 4 times and 6 h per week were similar to that of all subjects ; however , the improvement in anxiety in the GLQG group was more obvious . There are positive correlations between QoL and anxiety and depression . Conclusions Both GLQG and physical stretching are beneficial during recovery following breast cancer . GLQC was more effective in terms of Qol improvements than physical stretching . Both programs brought improvements in anxiety or depression but had were comparable . GLQC group had a greater effect on immunological function than physical exercise BACKGROUND Bojungikki-tang ( Bu-Zhong-Yi-Qi-Tang in Chinese or Hochu-ekki-to in Japanese ) is a widely used herbal prescription in traditional medicine in China , Japan , and Korea . The aim of this study was to investigate the effectiveness of Bojungikki-tang for cancer-related fatigue . METHODS A total of 40 patients with cancer-related fat
Output:
| As a whole , the results showed clearly superior efficacy of CIM in improving HRQOL .
For different domains of HRQOL , different CIM interventions may play different roles .
In conclusion , CIM may improve the HRQOL of cancer patients . |
MS213477 | ***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 It is well established that there is mutual interaction between the neuroendocrines and immune systems and that the disturbance in any one system could affect the function of the other . While there is a large body of evidence suggesting negative impact of human immunodeficiency virus type 1B ( HIV-1B ) infection on both immune and neuroendocrine systems , the consequence of HIV-1 clade C infection ( with structural differences from HIV-1B virus ) on these systems is not clearly understood . METHODS We carried out a 2-year longitudinal study on plasma profile of adrenocorticosteroids , including cortisol and DHEAS and their relationship with declining CD4 + cell counts in neurologically asymptomatic HIV-C infected individuals ( N=84 ) in order to underst and the impact of HIV-1 clade C infection on adrenocortical dysfunction and its relationship with the progressive decline in the cell mediated immunity . RESULTS We found that while plasma cortisol levels increased significantly at baseline in HIV-1C infected individuals compared to those in HIV-negative controls ( HIV-1C+ , 9.83+/-0.39 vs controls , 8.04+/-0.45 ; p<0.01 ) , there was a significant decrease in DHEAS in HIV-1C+ individuals , compared to that in HIV-negative controls ( 81.02+/-4.9 vs 185.1+/-12.03 , p<0.001 ) , and consequently a significant increase in cortisol : DHEAS ratio in HIV-1 clade C infected persons ( 0.19+/-0.002 vs control 0.058+/-0.006 ; p<0.001 ) . Moreover , in HIV-1C infected individuals , there was a strong positive correlation between DHEAS and CD4 cells ( r=0.2 ; p<0.05 ) , and a strong negative correlation between cortisol , as well as cortisol : DHEAS ratio and CD4 cells ( r=-0.25 ; p<0.01 ; and r=-0.31 ; p<0.001 , respectively ) . CONCLUSIONS These findings suggest the persistent and progressive adrenocortical dysfunction during the asymptomatic phase of HIV infection , and that the evaluation of increase in plasma cortisol , a decrease in DHEAS , and an increase in cortisol : DHEAS ratio may serve as important biomarkers preceding the impending down regulation of CD4 cell counts and progressive decline in the immune system function in HIV-1C infection . Furthermore , these findings may indicate the dysregulation of 3beta-hydroxysteroid dehydrogenase ( 3beta-HSD ) activity , the enzyme involved in the bio synthesis of cortisol and DHEA through the pregnenolone-progesterone pathway , and that it may offer an opportunity for drug discovery targeting re-regulation of 3beta-HSD activity for potential therapeutic application in HIV-1C infection Background : Women progress to death at the same rate as men despite lower plasma HIV RNA ( viral load ) . We investigated sex-specific differences in immune activation and inflammation as a potential explanation . Methods : Inflammatory and immune activation markers [ interferon & ggr ; , tumor necrosis factor ( TNF ) & agr ; , IL-6 , IL-18 , IFN-&ggr ;– induced protein 10 , C-reactive protein ( CRP ) , lipopolysaccharide , and sCD14 ] were measured at weeks 0 , 24 , and 48 after combination antiretroviral therapy ( cART ) in a r and om subcohort ( n = 215 ) who achieved virologic suppression in ACTG A5175 ( Prospect i ve Evaluation of Antiretrovirals in Re source -Limited Setting s ) . Association between sex and changes in markers post-cART was examined using r and om effects models . Average marker differences and 95 % confidence intervals were estimated using multivariable models . Results : At baseline , women had lower median log10 viral load ( 4.93 vs 5.18 copies per milliliter , P = 0.01 ) , CRP ( 2.32 vs 4.62 mg/L , P = 0.01 ) , detectable lipopolysaccharide ( 39 % vs 55 % , P = 0.04 ) , and sCD14 ( 1.9 vs 2.3 µg/mL , P = 0.06 ) vs men . By week 48 , women had higher interferon & ggr ; ( 22.4 vs 14.9 pg/mL , P = 0.05 ) , TNF-&agr ; ( 11.5 vs 9.5 pg/mL , P = 0.02 ) , and CD4 ( 373 vs 323 cells per cubic millimeter , P = 0.02 ) . In multivariate analysis , women had greater increases in CD4 and TNF-&agr ; but less of a decrease in CRP and sCD14 compared with men . Conclusions : With cART-induced viral suppression , women have less reduction in key markers of inflammation and immune activation compared with men . Future studies should investigate the impact of these sex-specific differences on morbidity and mortality Objective : Psychological risk factors ( PRFs ) are associated with impaired learning and memory in HIV-infected ( HIV+ ) women . We determined the dynamic nature of the effects of PRFs and HIV serostatus on learning and memory over time . Design : Multicenter , prospect i ve cohort study . Methods : Every 2 years between 2009 and 2013 ( three times ) , 646 HIV+ and 300 demographically similar HIV-uninfected ( HIV− ) women from the Women 's Interagency HIV Study completed neuropsychological testing and question naires measuring PRFs [ perceived stress , posttraumatic stress disorder ( PTSD ) symptoms , depressive symptoms ] . Using mixed-effects regressions , we examined separate and interactive associations between HIV-serostatus and PRFs on performance over time . Results : HIV+ and HIV− women had similar rates of PRFs . Fluency was the only domain in which performance over time depended on the combined influence of HIV-serostatus and stress or PTSD ( P < 0.05 ) , not depression . In HIV , higher stress and PTSD were associated with a greater cognitive decline in performance ( P < 0.05 ) vs. lower stress and PTSD . Irrespective of time , performance on learning and memory depended on the combined influence of HIV-serostatus and stress or PTSD ( P ⩽ 0.05 ) . In the context of HIV , stress and PTSD were negatively associated with performance . Effects were pronounced on learning among HIV+ women without effective treatment or viral suppression . Regardless of time or HIV-serostatus , all PRFs were associated with lower speed , global neuropsychological , and executive function . Conclusion : More than depression , perceived stress and PTSD symptoms are treatment targets to potentially improve fluency , learning , and memory in women living with HIV particularly when HIV treatment is not optimal Objective : Inflammatory biomarkers associated with cardiovascular disease are elevated in HIV-infected persons . These biomarkers improve with antiretroviral therapy ( ART ) but do not normalize to values observed in HIV-uninfected adults . Little is known regarding biomarkers of inflammation in HIV-infected Peruvians , in whom an increased burden of infectious diseases may exacerbate inflammation , and women , in whom sex difference may alter inflammation compared with men . Methods : Peruvians initiating first-line ART were enrolled in a prospect i ve observational study . Individuals with suppression of HIV RNA plasma loads to less than 30 copies/ml when determined quarterly over 24 months of ART , had biomarkers of inflammation and cellular activation measured pre-ART and at 24-months of ART , and evaluated for associations with sex and clinical parameters . Results : Pre-ART high-sensitivity C-reactive protein ( hsCRP ) values of men were in the high-risk cardiovascular disease category ( > 3.0 mg/l ) more frequently compared with women ( P = 0.02 ) ; most women 's values were in the low/average-risk categories . At 24 months of suppressive ART , hsCRP concentrations decreased in men ( P = 0.03 ) , but tended to increase in women , such that the proportion with high-risk hsCRP did not differ by sex . Pre-ART , soluble CD163 concentrations were higher in women compared with men ( P = 0.02 ) , and remained higher after 24 months of suppressive ART ( P = 0.02 ) . All other inflammatory biomarkers ( P < 0.03 ) decreased across sexes . Biomarker concentrations were not associated with BMI or coinfections . Conclusion : Elevated inflammatory biomarkers persisted despite 24 months of suppressive ART in a subset of Peruvians , and to a greater extent in women compared with men . These findings suggest that lifestyle or pharmacologic interventions may be required to optimize the health of HIV-infected Peruvians , particularly women Background Levels of high-sensitivity C-reactive protein ( hsCRP ) , interleukin-6 ( IL-6 ) , and D-dimer predict mortality in HIV patients on antiretroviral therapy ( ART ) with relatively preserved CD4 + T cell counts . We hypothesized that elevated pre-ART levels of these markers among patients with advanced HIV would be associated with an increased risk of death following the initiation of ART . Methods Pre-ART plasma from patients with advanced HIV in South Africa was used to measure hsCRP , IL-6 and D-dimer . Using a nested case-control study design , the biomarkers were measured for 187 deaths and two controls matched on age , sex , clinical site , follow-up time and CD4 + cell counts . Odds ratios were estimated using conditional logistic regression . In addition , for a r and om sample of 100 patients , biomarkers were measured at baseline and 6 months following r and omization to determine whether ART altered their levels . Results Median baseline biomarkers levels for cases and controls , respectively , were 11.25 vs. 3.6 mg/L for hsCRP , 1.41 vs. 0.98 mg/L for D-dimer , and 9.02 vs. 4.20 pg/mL for IL-6 ( all p<0.0001 ) . Adjusted odds ratios for the highest versus lowest quartile of baseline biomarker levels were 3.5 ( 95 % CI : 1.9–6.7 ) for hsCRP , 2.6 ( 95%CI 1.4–4.9 ) for D-dimer , and 3.8 ( 95 % CI : 1.8–7.8 ) for IL-6 . These associations were stronger for deaths that occurred more proximal to the biomarker measurements . Levels of D-dimer and IL-6 , but not hsCRP , were significantly lower at month 6 after commencing ART compared to baseline ( p<0.0001 ) . Conclusions Among patients with advanced HIV disease , elevated pre-ART levels of hsCRP , IL-6 and D-dimer are strongly associated with early mortality after commencing ART . Elevated levels of inflammatory and coagulation biomarkers may identify patients who may benefit from aggressive clinical monitoring after commencing ART . Further investigation of strategies to reduce biomarkers of inflammation and coagulation in patients with advanced HIV disease is warranted . Trial Registration Parent Study : Clinical Trials.gov Background In the Strategies for Management of Anti-Retroviral Therapy trial , all-cause mortality was higher for participants r and omized to intermittent , CD4-guided antiretroviral treatment ( ART ) ( drug conservation [ DC ] ) than continuous ART ( viral suppression [ VS ] ) . We hypothesized that increased HIV-RNA levels following ART interruption induced activation of tissue factor pathways , thrombosis , and fibrinolysis . Methods and Findings Stored sample s were used to measure six biomarkers : high sensitivity C-reactive protein ( hsCRP ) , interleukin-6 ( IL-6 ) , amyloid A , amyloid P , D-dimer , and prothrombin fragment 1 + 2 . Two studies were conducted : ( 1 ) a nested case – control study for study ing biomarker associations with mortality , and ( 2 ) a study to compare DC and VS participants for biomarker changes . For ( 1 ) , markers were determined at study entry and before death ( latest level ) for 85 deaths and for two controls ( n = 170 ) matched on country , age , sex , and date of r and omization . Odds ratios ( ORs ) were estimated with logistic regression . For each biomarker , each of the three upper quartiles was compared to the lowest quartile . For ( 2 ) , the biomarkers were assessed for 249 DC and 250 VS participants at study entry and 1 mo following r and omization . Higher levels of hsCRP , IL-6 , and D-dimer at study entry were significantly associated with an increased risk of all-cause mortality . Unadjusted ORs ( highest versus lowest quartile ) were 2.0 ( 95 % confidence interval [ CI ] , 1.0–4.1 ; p = 0.05 ) , 8.3 ( 95 % CI , 3.3–20.8 ; p < 0.0001 ) , and 12.4 ( 95 % CI , 4.2–37.0 ; p < 0
Output:
| A power analysis showed that few HIV studies have sufficient power to address male/female differences in NCI but studies with adequate power find evidence of greater NCI in WLWH , particularly in the domains of memory , speed of information processing , and motor function .
Sex is an important determinant of NCI in HIV , and may relate to male/female differences in cognitive reserve , comorbidities ( mental health and substance use disorders ) , and biological factors ( e.g. , inflammation , hormonal , genetic ) |
MS213478 | ***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: The possible differences in processing gustatory stimuli in anorexic patients compared to healthy control subjects was investigated by electrophysiological methods . The electroencephalogram ( EEG ) was recorded in out patients treated with anorexia nervosa ( AN ) and age-matched controls after exposure to sweet ( milk chocolate ) and bitter ( black tea ) taste stimuli . Power spectrum analysis was performed on EEG epochs recorded in the above conditions . Compared to controls a significantly higher percent of theta , and lower percent of alpha1 b and power was found in anorexic patients , irrespective of the kind of taste effects and hemispheric side . The pattern of activation caused by sweet and bitter stimuli was found to be different in these two groups , possibly indicating altered gustatory processing mechanisms in AN We evaluated the changes in taste responsiveness of anorexia nervosa ( AN ) patients during behavior therapy . Taste responsiveness of AN patients was lower at admission when compared to controls but it improved significantly over the course of treatment ( p < 0.01 ) . Taste responsiveness improved prior to increase in body weight . No significant correlation was noted between weight gain and improvement in taste responsiveness . The period required to reach a food intake of 1600 Kcal/day and the duration of hospitalization were highly correlated ( r = 0.72 , p < 0.05 ) . Those who reached 1600 Kcal/day earlier showed more rapid improvements in taste responsiveness . These results suggest that decreased taste responsiveness in AN patients can rapidly improve and such early improvement may result in better progression of treatment Restrictive eating disorders ( ED ) are increasing and represent a serious risk to the health of adolescent females . Restrictive ED in youth are often treated through aggressive short-term refeeding . Although evidence supports that this intervention is the " gold st and ard " for improving ED outcomes in youth , little research has specifically probed appetite and meal-related responses to this type of intensive , short-term refeeding in newly diagnosed individuals . Information about appetite and meal-related dysfunction could provide valuable insights regarding treatment-interfering features of ED in both acute inpatient and longer-term outpatient treatment . The purpose of this study was to evaluate the hunger , fullness , olfactory , and gustatory responses of adolescents with newly-diagnosed restrictive ED and to probe how and when these responses are altered by refeeding . Using a quasi-experimental ecologically valid methodology , this study described and compared profiles of hunger , fullness , olfactory , and gustatory responses in adolescent females ( n = 15 ) with newly diagnosed restrictive ED at hospital admission ( i.e. , severe malnutrition ) and after medical refeeding , in comparison to healthy controls ( n = 15 ) . Results showed that newly diagnosed ( i.e. , malnourished ) adolescents with ED showed significantly different meal-related experiences than controls . Refeeding improved some of these differences , but not all . Following refeeding , females with ED continued to show lower hunger , greater fullness , and lower pleasantness of smell ratings compared to controls . Unpleasantness of taste ratings maladaptively increased , such that females who were re-fed reported more aversive scents than pre-treatment . Profiles of meal-related responses were also identified and compared between groups . The applicability of these findings are discussed within the context of critical periods of change during refeeding treatment and potentially promising intervention targets that might enhance treatment outcomes for adolescents with newly onset , restrictive ED Taste responses to sucrose and fat-containing stimuli were examined in a population of young women with eating disorders . Anorectic-restrictor and anorectic-bulimic patients were compared with normal-weight bulimic patients and with normal-weight control subjects . Sensory estimates of sweetness and fat content of 20 different mixtures of milk , cream , and sugar did not differ among subject groups . In contrast , relative preferences for sugar vs fat as determined by the Response Surface Method differed between patients with eating disorders and control subjects . Normal-weight bulimic patients preferred sweeter stimuli than did control subjects . Anorectic-restrictor and anorectic-bulimic patients liked sweet but disliked high-fat stimuli and showed elevated optimal sugar : fat ( S : F ) ratios . This pattern of response did not change following weight regain . The stability of preference profiles suggests that taste responsiveness may be independent of diagnostic categories , bulimic behaviors , or acute changes in body weight To test the hypothesis that endogenous opiate peptides selectively influence hedonic response to sweet and high-fat foods , the opiate antagonist naloxone , opiate agonist butorphanol , and a saline placebo were administered by intravenous infusion to 16 obese and 25 normal-weight women . Twenty of the women ( 10 obese , 10 lean ) fulfilled DSM-III-R diagnostic criteria for bulimia nervosa , as determined by psychiatric interview . During drug infusion the women tasted and rated 20 sweetened dairy products and were presented with eight snack foods of varying sugar and fat content . Naloxone suppressed hedonic responses in all subject groups and suppressed the consumption of sweet and high-fat foods in binge eaters , but not in nonbingers . Food intakes of obese women were not affected by naloxone . Butorphanol had no effect on either hedonic response or on food consumption in any group . Although opiate blockade is not a viable strategy for weight reduction in the treatment of obesity , it may be useful in the clinical management of the binge-eating disorder The aim of this study was to identify cortical areas important for optimal cognitive aging . 74 participants ( 20 - 88 years ) went through neuropsychological tests and two MR sessions . The sample was split into two age groups . In each , every participant was classified as " high " or " average " on fluid ability tests and on neuropsychological tests related to executive function . The groups were compared with regard to thickness on a point-by-point basis across the entire cortical mantle . The old high fluid performers had thicker cortex than the average performers in large areas of cortex , while there was minimal difference between the groups of high vs. average executive function . Furthermore , the old group with high fluid function had thicker cortex than the young participants in the posterior cingulate and adjacent areas . Further analyses showed that the latter was a result of a complex aging pattern , differing between the two performance groups , with decades of cortical thickening and subsequent thinning Binge eating is often preceded by reports of negative affect , but the mechanism by which affect may lead to binge eating is unclear . This study evaluated the effect of negative affect on neural response to anticipation and receipt of palatable food in women with bulimia nervosa ( BN ) versus healthy controls . We also evaluated connectivity between the amygdala and reward-related brain regions . Females with and without BN ( n=26 ) underwent functional magnetic resonance imaging ( fMRI ) during receipt and anticipated receipt of chocolate milkshake and a tasteless solution . We measured negative affect just prior to the scan . Women with BN showed a positive correlation between negative affect and activity in the putamen , cau date , and pallidum during anticipated receipt of milkshake ( versus tasteless solution ) . There were no significant relations between negative affect and receipt of milkshake . Connectivity analyses revealed a greater relation of amygdala activity to activation in the left putamen and insula during anticipated receipt of milkshake in the bulimia group relative to the control group . The opposite pattern was found for the taste of milkshake ; the control group showed a greater relation of amygdala activity to activation in the left putamen and insula in response to milkshake receipt than the bulimia group . Results show that as negative affect increases , so does responsivity of reward regions to anticipated intake of palatable food , implying that negative affect may increase the reward value of food for individuals with bulimia nervosa or that negative affect has become a conditioned cue due to a history of binge eating in a negative mood Preferences and cravings for sweet high-fat foods observed among obese and bulimic patients may involve the endogenous opioid peptide system . The opioid antagonist naloxone , opioid agonist butorphanol , and saline placebo were administered by intravenous infusion to 14 female binge eaters and 12 normal-weight controls . Eight of the binge eaters were obese . During infusion , the subjects tasted 20 sugar/fat mixtures and were allowed to select and consume snack foods of varying sugar and fat content . Naloxone reduced taste preferences relative to baseline in both binge eaters and controls . Total caloric intake from snacks was significantly reduced by naloxone in binge eaters but not in controls . This reduction was most pronounced for sweet high-fat foods such as cookies or chocolate . No consistent effects on taste preferences or food intakes were observed with butorphanol . Endogenous opioid peptides may be involved in mediating taste responses and preferences for palatable foods , notably those rich in sugar and fat OBJECTIVE Most previous studies of the prevalence , incidence , and outcome of anorexia nervosa have been limited to cases detected through the health care system , which may bias our underst and ing of the disorder 's incidence and natural course . The authors sought to describe the onset and outcomes of anorexia nervosa in the general population . METHOD Lifetime prevalences , incidence rates , and 5-year recovery rates of anorexia nervosa were calculated on the basis of data from 2,881 women from the 1975 - 1979 birth cohorts of Finnish twins . Women who screened positive for eating disorder symptoms ( N=292 ) , their screen-negative female co-twins ( N=134 ) , and 210 r and omly selected screen-negative women were assessed for lifetime eating disorders by telephone by experienced clinicians . To assess outcomes after clinical recovery and to detect residua of illness , women who had recovered were compared with their unaffected co-twins and healthy unrelated women on multiple outcome measures . RESULTS The lifetime prevalence of DSM-IV anorexia nervosa was 2.2 % , and half of the cases had not been detected in the health care system . The incidence of anorexia nervosa in women between 15 and 19 years of age was 270 per 100,000 person-years . The 5-year clinical recovery rate was 66.8 % . Outcomes did not differ between detected and undetected cases . After clinical recovery , the residua of illness steadily receded . By 5 years after clinical recovery , most prob and s had reached complete or nearly complete psychological recovery and closely resembled their unaffected co-twins and healthy women in weight and most psychological and social measures . CONCLUSIONS The authors found a substantially higher lifetime prevalence and incidence of anorexia nervosa than reported in previous studies , most of which were based on treated cases . Most women recovered clinical ly within 5 years , and thereafter usually progressed toward full recovery Previous research has shown that patients with bulimia nervosa ( B ) , anorexia nervosa , restricting type , or restrictive-anorectic ( RA ) , and anorexia nervosa , binge eating , purging type , or anorectic-bulimic ( AB ) exhibit a reduced hedonic response to sucrose compared with control subjects . We hypothesized that this response could be linked to an excessive fear of weight gain rather than a decreased ability to experience pleasure . We therefore compared the hedonic responses to sucrose solutions in B , RA and AB women ( n=20/group ) in two different conditions : sucrose solution swallowed vs. sucrose solution spit . Under double-blind conditions and according to a Latin square design , patients received sucrose in solution ( 0 , 5 , 10 , 20 , and 40 % ) and rated each concentration for pleasantness on a nine-point scale . The two test conditions were r and omly administered . The threshold concentration of sweet taste perception was also assessed , and the subjects filled out Chapman 's Social and Physical Anhedonia Scale . The hedonic response to sucrose adjusted for the sweet taste perception threshold was significantly lower in the ' swallow ' than in the ' spit ' condition . There was a significant effect of sucrose concentrations as well as a significant condition by concentration interaction . When ' fear to swallow ' sucrose solution responses were included as a covariate , the significant difference between the conditions of ' swallow ' or ' spit ' disappeared , but there was a significant concentration by condition by fear to swallow interaction and an almost significant covariate effect . When ' Drive for Thinness ' on the Eating Disorder Inventory was included as a covariate , similar results were obtained . Social Anhedonia but not Physical Anhedonia correlated positively with ' Drive for Thinness ' and ' fear of swallowing sucrose solutions ' , and correlated inversely with maximal hedonic response to the ' swallow ' condition . ' We conclude that the hedonic responses to sucrose in patients with eating disorders are decreased when solutions are swallowed . This may reflect excessive fear of gaining weight rather than decreased ability to experience pleasure ' The overall aim of the present study was to investigate a new method for the screening of taste function in a clinical context . Instead of dripping liquids onto the tongue , thin edible wavers were used . One-hundred healthy subjects participated in the study ( 41 male , 59 female ; mean age : 52 years ; age range : 20 - 89 years ) . Supra-threshold taste stimuli were presented as flavoured wavers made from flour and water . Sequential testing was performed regionally on the anterior one-third of the tongue and as whole mouth testing . When comparing ratings for the 5 different wavers separately for regional and whole mouth testing , differences between qualities only emerged for regional testing . Women were found to have less difficulty in taste identification which was most pronounced for regional testing . No effects of the subjects ' age were observed . In conclusion , the wavers were found to be easy to use ; they have a shelf-life of 2 to 3 years and can be carried in the pocket . The results indicate that the wavers may be suited for the screening of gustatory function , especially in a clinical setting Although it is possible that binge eating in humans is due to increased responsiveness of orosensory excitatory controls of eating , there is no direct evidence for this because food
Output:
| Psychophysical studies showed that individuals with BN , in general , had greater preference for sweetness than healthy controls , and those with AN had a greater aversion for fat than controls .
In neuroimaging studies , findings suggested that predictable administration of sweet-taste stimuli was associated with reduced activation in taste-reward regions of the brain among individuals with AN ( e.g. , insula , ventral , and dorsal striatum ) but increased activation in BN and BED .
Discussion : To our knowledge , this systematic review is the first to synthesize literature on taste differences in AN , BN , and BED . |
MS213479 | ***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: Severe osteoporosis frequently is observed after organ transplantation . In kidney transplantation , it adds to pre-existing renal bone disease and strategies to prevent osteoporosis are not established . Eighty kidney recipients were included in a r and omized controlled prospect i ve intervention trial . Treated patients ( n = 40 ) received an injection of ib and ronate , a bisphosphonate , immediately before and at 3 , 6 , and 9 mo after transplantation . The primary outcome measured was the change in bone mineral density . Secondary measures included graft outcome , spinal deformities , fracture rate , body height , and hormonal and metabolic data . Loss of spongy and cortical bone after transplantation was prevented by ib and ronate . Changes of bone mineral density ( ib and ronate versus controls ) were as follows : lumbar spine , -0.9 + /- 6.1 % versus -6.5 + /- 5.4 % ( P < 0.0001 ) ; femoral neck , + 0.5 + /- 5.2 % versus -7.7 + /- 6.5 % ( P < 0.0001 ) ; and midfemoral shaft , + 2.7 + /- 12.2 % versus -4.0 + /- 10.9 % ( P = 0.024 ) . Fewer spinal deformities developed with ib and ronate ( 7 patients with 7 deformities versus 12 patients with 23 deformities ; P = 0.047 ) . Loss of body height was 0.5 + /- 1.0 cm versus 1.1 + /- 1.0 cm in control subjects ( P = 0.040 ) . Two bone fractures occurred in each group . There were fewer acute rejection episodes with ib and ronate ( 11 versus 22 ; P = 0.009 ) . Graft function after 1 yr was comparable . Bone loss , spinal deformation , and loss of body height during the first year after kidney transplantation are prevented by injection of ib and ronate at intervals of 3 mo . The smaller number of rejection episodes of the ib and ronate-treated group should be confirmed and its mechanism should be explored in additional studies BACKGROUND Osteopenia is a major complication of renal transplantation . Immunosuppressive regimens including cyclosporine , which permit the use of lower doses of glucocorticoids , may reduce glucocorticoid-induced osteopenia . METHODS We prospect ively studied the magnitude , distribution , and mechanism of bone loss in 20 adults who received renal allografts from living related donors , who had good renal function , and who were treated with azathioprine , cyclosporine , and low doses of prednisone . We measured serum biochemical markers of bone metabolism , determined the bone mineral density of the second , third , and fourth lumbar vertebrae and the shaft of the radius , and analyzed the histomorphometric features of iliac bone at the time of transplantation and six months later . Measurements of vertebral mineral density were repeated 18 months after transplantation in 17 of the patients . RESULTS After transplantation , the mean serum concentrations of parathyroid hormone , phosphorus , and alkaline phosphatase decreased and the serum calcitriol concentration increased . The mean ( + /- SD ) bone mineral density of the vertebrae had decreased 6.8 + /- 5.6 percent 6 months after transplantation ( P less than 0.05 ) and 8.8 + /- 7.0 percent 18 months after transplantation . In contrast , the bone mineral density of the radius had increased six months after transplantation ( P less than 0.05 ) . The histomorphometric studies showed that the rate of bone formation decreased from 50.5 + /- 44.8 to 23.1 + /- 13.8 microns3 per square micrometer per year ( P less than 0.05 ) , and the formation period lengthened from 70 + /- 42 to 146 + /- 144 days ( P less than 0.05 ) . Consequently , the amount of bone replaced during a remodeling cycle diminished . CONCLUSIONS Osteopenia associated with renal transplantation remains a problem in the cyclosporine era . The loss of vertebral bone in our subjects was due to an imbalance in bone remodeling consistent with a toxic effect of glucocorticoids BACKGROUND Previous studies have shown that alendronate can increase bone mineral density ( BMD ) and prevent radiographically defined ( morphometric ) vertebral fractures . The Fracture Intervention Trial aim ed to investigate the effect of alendronate on the risk of morphometric as well as clinical ly evident fractures in postmenopausal women with low bone mass . METHODS Women aged 55 - 81 with low femoral-neck BMD were enrolled in two study groups based on presence or absence of an existing vertebral fracture . Results for women with at least one vertebral fracture at baseline are reported here . 2027 women were r and omly assigned placebo ( 1005 ) or alendronate ( 1022 ) and followed up for 36 months . The dose of alendronate ( initially 5 mg daily ) was increased ( to 10 mg daily ) at 24 months , with maintenance of the double blind . Lateral spine radiography was done at baseline and at 24 and 36 months . New vertebral fractures , the primary endpoint , were defined by morphometry as a decrease of 20 % ( and at least 4 mm ) in at least one vertebral height between the baseline and latest follow-up radiograph . Non-spine clinical fractures were confirmed by radiographic reports . New symptomatic vertebral fractures were based on self-report and confirmed by radiography . FINDINGS Follow-up radiographs were obtained for 1946 women ( 98 % of surviving participants ) . 78 ( 8.0 % ) of women in the alendronate group had one or more new morphometric vertebral fractures compared with 145 ( 15.0 % ) in the placebo group ( relative risk 0.53 [ 95 % Cl 0.41 - 0.68 ] ) . For clinical ly apparent vertebral fractures , the corresponding numbers were 23 ( 2.3 % ) alendronate and 50 ( 5.0 % ) placebo ( relative hazard 0.45 [ 0.27 - 0.72 ] ) . The risk of any clinical fracture , the main secondary endpoint , was lower in the alendronate than in the placebo group ( 139 [ 13.6 % ] vs 183 [ 18.2 % ] ; relative hazard 0.72 [ 0.58 - 0.90 ] ) . The relative hazards for hip fracture and wrist fracture for alendronate versus placebo were 0.49 ( 0.23 - 0.99 ) and 0.52 ( 0.31 - 0.87 ) . There was no significant difference between the groups in numbers of adverse experiences , including upper-gastrointestinal disorders . INTERPRETATION We conclude that among women with low bone mass and existing vertebral fractures , alendronate is well tolerated and substantially reduces the frequency of morphometric and clinical vertebral fractures , as well as other clinical fractures Background . This prospect i ve study was design ed to investigate the long-term evolution of bone mineral density ( BMD ) in kidney transplant recipients . Methods . In 86 patients with functioning grafts , 65 on tacrolimus-based immunosuppression and 21 on cyclosporine-based immunosuppression , laboratory parameters and BMD measurements in lumbar spine ( L2–L4 ) and femoral neck ( FN ) were performed by DEXA in the first month after transplantation ( baseline ) and yearly thereafter up to the fourth year . Results . BMD did not change at 12 months in lumbar spine nor in the FN . Detailed analysis identified three patterns of BMD in lumbar spine at 12 months : BMD remained stable in 27 patients ( 31.4 % ) , decreased > 2 % in 31 ( 36.0 % ) and increased > 2 % in 28 ( 32.6 % ) . Patients with no change or gain presented a parallel increase of BMD in FN ( P<0.001 in both groups ) . On multivariate analysis , the variables associated with no change or lumbar BMD loss were total prednisone dose in grams at 12 months ( OR 1.402 ; 95 % CI 1.038–1.893 ; P=0.028 ) , calcitriol levels at 12 months ( OR 0.936 ; 95 % CI 0.892–0.982 ; P=0.007 ) and lumbar BMD at baseline ( OR 1.006 ; 95 % CI 1.002–1.010 ; P=0.002 ) . Late treatment with calcium supplements and calcitriol did not improve osteopenia . Conclusions . One third of patients had bone loss mainly during the first year of follow-up . Bone loss was associated to higher baseline BMD , high steroid dose , and lower calcitriol levels at 1 year . Late administration of calcitriol and calcium supplements did not improve posttransplant osteopenia . More than 50 % of patients were osteopenic 4 years after transplantation CONTEXT Alendronate sodium reduces fracture risk in postmenopausal women who have vertebral fractures , but its effects on fracture risk have not been studied for women without vertebral fractures . OBJECTIVE To test the hypothesis that 4 years of alendronate would decrease the risk of clinical and vertebral fractures in women who have low bone mineral density ( BMD ) but no vertebral fractures . DESIGN R and omized , blinded , placebo-controlled trial . SETTING Eleven community-based clinical research centers . SUBJECTS Women aged 54 to 81 years with a femoral neck BMD of 0.68 g/cm2 or less ( Hologic Inc , Waltham , Mass ) but no vertebral fracture ; 4432 were r and omized to alendronate or placebo and 4272 ( 96 % ) completed outcome measurements at the final visit ( an average of 4.2 years later ) . INTERVENTION All participants reporting calcium intakes of 1000 mg/d or less received a supplement containing 500 mg of calcium and 250 IU of cholecalciferol . Subjects were r and omly assigned to either placebo or 5 mg/d of alendronate sodium for 2 years followed by 10 mg/d for the remainder of the trial . MAIN OUTCOME MEASURES Clinical fractures confirmed by x-ray reports , new vertebral deformities detected by morphometric measurements on radiographs , and BMD measured by dual x-ray absorptiometry . RESULTS Alendronate increased BMD at all sites studied ( P<.001 ) and reduced clinical fractures from 312 in the placebo group to 272 in the intervention group , but not significantly so ( 14 % reduction ; relative hazard [ RH ] , 0.86 ; 95 % confidence interval [ CI ] , 0.73 - 1.01 ) . Alendronate reduced clinical fractures by 36 % in women with baseline osteoporosis at the femoral neck ( > 2.5 SDs below the normal young adult mean ; RH , 0.64 ; 95 % CI , 0.50 - 0.82 ; treatment-control difference , 6.5 % ; number needed to treat [ NNT ] , 15 ) , but there was no significant reduction among those with higher BMD ( RH , 1.08 ; 95 % CI , 0.87 - 1.35 ) . Alendronate decreased the risk of radiographic vertebral fractures by 44 % overall ( relative risk , 0.56 ; 95 % CI , 0.39 - 0.80 ; treatment-control difference , 1.7 % ; NNT , 60 ) . Alendronate did not increase the risk of gastrointestinal or other adverse effects . CONCLUSIONS In women with low BMD but without vertebral fractures , 4 years of alendronate safely increased BMD and decreased the risk of first vertebral deformity . Alendronate significantly reduced the risk of clinical fractures among women with osteoporosis but not among women with higher BMD The clinical profile of ib and ronate as add‐on to calcitriol and calcium was studied in this double‐blind , placebo‐controlled trial of 129 renal transplant recipients with early stable renal function ( ≤ 28 days posttransplantation , GFR ≥ 30 mL/min ) . Patients were r and omized to receive i.v . ib and ronate 3 mg or i.v . placebo every 3 months for 12 months on top of oral calcitriol 0.25 mcg/day and calcium 500 mg b.i.d . At baseline , 10 weeks and 12 months bone mineral density ( BMD ) and biochemical markers of bone turnover were measured . The primary endpoint , relative change in BMD for the lumbar spine from baseline to 12 months was not different , + 1.5 % for ib and ronate versus + 0.5 % for placebo ( p = 0.28 ) . Ib and ronate demonstrated a significant improvement of BMD in total
Output:
| There was no difference in fracture incidence in the two groups .
Bisphosphonate therapy in kidney transplant recipients is associated with a statistically significant improvement in BMD at the lumbar spine and femoral neck .
There was no difference in fracture incidence .
Bisphosphonates did not adversely affect allograft dysfunction or serum calcium levels |
MS213480 | ***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 comparative effectiveness of treatments for prostate cancer that is detected by prostate-specific antigen ( PSA ) testing remains uncertain . METHODS We compared active monitoring , radical prostatectomy , and external-beam radiotherapy for the treatment of clinical ly localized prostate cancer . Between 1999 and 2009 , a total of 82,429 men 50 to 69 years of age received a PSA test ; 2664 received a diagnosis of localized prostate cancer , and 1643 agreed to undergo r and omization to active monitoring ( 545 men ) , surgery ( 553 ) , or radiotherapy ( 545 ) . The primary outcome was prostate-cancer mortality at a median of 10 years of follow-up . Secondary outcomes included the rates of disease progression , metastases , and all-cause deaths . RESULTS There were 17 prostate-cancer-specific deaths overall : 8 in the active-monitoring group ( 1.5 deaths per 1000 person-years ; 95 % confidence interval [ CI ] , 0.7 to 3.0 ) , 5 in the surgery group ( 0.9 per 1000 person-years ; 95 % CI , 0.4 to 2.2 ) , and 4 in the radiotherapy group ( 0.7 per 1000 person-years ; 95 % CI , 0.3 to 2.0 ) ; the difference among the groups was not significant ( P=0.48 for the overall comparison ) . In addition , no significant difference was seen among the groups in the number of deaths from any cause ( 169 deaths overall ; P=0.87 for the comparison among the three groups ) . Metastases developed in more men in the active-monitoring group ( 33 men ; 6.3 events per 1000 person-years ; 95 % CI , 4.5 to 8.8 ) than in the surgery group ( 13 men ; 2.4 per 1000 person-years ; 95 % CI , 1.4 to 4.2 ) or the radiotherapy group ( 16 men ; 3.0 per 1000 person-years ; 95 % CI , 1.9 to 4.9 ) ( P=0.004 for the overall comparison ) . Higher rates of disease progression were seen in the active-monitoring group ( 112 men ; 22.9 events per 1000 person-years ; 95 % CI , 19.0 to 27.5 ) than in the surgery group ( 46 men ; 8.9 events per 1000 person-years ; 95 % CI , 6.7 to 11.9 ) or the radiotherapy group ( 46 men ; 9.0 events per 1000 person-years ; 95 % CI , 6.7 to 12.0 ) ( P<0.001 for the overall comparison ) . CONCLUSIONS At a median of 10 years , prostate-cancer-specific mortality was low irrespective of the treatment assigned , with no significant difference among treatments . Surgery and radiotherapy were associated with lower incidences of disease progression and metastases than was active monitoring . ( Funded by the National Institute for Health Research ; ProtecT Current Controlled Trials number , IS RCT N20141297 ; Clinical Trials.gov number , NCT02044172 . ) OBJECTIVE To establish a score threshold that constitutes a clinical ly relevant change for each domain of the Exp and ed Prostate Cancer Index Composite ( EPIC ) Short Form ( EPIC-26 ) . Although its use in clinical practice and clinical trials has increased worldwide , the clinical interpretation of this 26-item disease-specific patient-reported quality of life question naire for men with localized prostate cancer would be facilitated by characterization of score thresholds for clinical ly relevant change ( the minimally important differences [ MIDs ] ) . METHODS We used distribution- and anchor-based approaches to establish the MID range for each EPIC-26 domain ( urinary , sexual , bowel , and vitality/hormonal ) based on a prospect i ve multi-institutional cohort of 1201 men treated for prostate cancer between 2003 and 2006 and followed up for 3 years after treatment . For the anchor-based approach , we compared within-subject and between-subject score changes for each domain to an external " anchor " measure of overall cancer treatment satisfaction . RESULTS We found the bowel and vitality/hormonal domains to have the lowest MID range ( a 4 - 6 point change should be considered clinical ly relevant ) , whereas the sexual domain had the greatest MID values ( 10 - 12 ) . Urinary incontinence appeared to have a greater MID range ( 6 - 9 ) than the urinary irritation/obstruction domain ( 5 - 7 ) . CONCLUSION Using 2 independent approaches , we established the MIDs for each EPIC-26 domain . A definition of these MID values is essential for the research er or clinician to underst and when changes in symptom burden among prostate cancer survivors are clinical ly relevant BACKGROUND The absence of trial data comparing robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy is a crucial knowledge gap in uro-oncology . We aim ed to compare these two approaches in terms of functional and oncological outcomes and report the early postoperative outcomes at 12 weeks . METHOD In this r and omised controlled phase 3 study , men who had newly diagnosed clinical ly localised prostate cancer and who had chosen surgery as their treatment approach , were able to read and speak English , had no previous history of head injury , dementia , or psychiatric illness or no other concurrent cancer , had an estimated life expectancy of 10 years or more , and were aged between 35 years and 70 years were eligible and recruited from the Royal Brisbane and Women 's Hospital ( Brisbane , QLD ) . Participants were r and omly assigned ( 1:1 ) to receive either robot-assisted laparoscopic prostatectomy or radical retropubic prostatectomy . R and omisation was computer generated and occurred in blocks of ten . This was an open trial ; however , study investigators involved in data analysis were masked to each patient 's condition . Further , a masked central pathologist review ed the biopsy and radical prostatectomy specimens . Primary outcomes were urinary function ( urinary domain of EPIC ) and sexual function ( sexual domain of EPIC and IIEF ) at 6 weeks , 12 weeks , and 24 months and oncological outcome ( positive surgical margin status and biochemical and imaging evidence of progression at 24 months ) . The trial was powered to assess health-related and domain-specific quality of life outcomes over 24 months . We report here the early outcomes at 6 weeks and 12 weeks . The per- protocol population s were included in the primary and safety analyses . This trial was registered with the Australian New Zeal and Clinical Trials Registry ( ANZCTR ) , number ACTRN12611000661976 . FINDINGS Between Aug 23 , 2010 , and Nov 25 , 2014 , 326 men were enrolled , of whom 163 were r and omly assigned to radical retropubic prostatectomy and 163 to robot-assisted laparoscopic prostatectomy . 18 withdrew ( 12 assigned to radical retropubic prostatectomy and six assigned to robot-assisted laparoscopic prostatectomy ) ; thus , 151 in the radical retropubic prostatectomy group proceeded to surgery and 157 in the robot-assisted laparoscopic prostatectomy group . 121 assigned to radical retropubic prostatectomy completed the 12 week question naire versus 131 assigned to robot-assisted laparoscopic prostatectomy . Urinary function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery ( 74·50 vs 71·10 ; p=0·09 ) or 12 weeks post-surgery ( 83·80 vs 82·50 ; p=0·48 ) . Sexual function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery ( 30·70 vs 32·70 ; p=0·45 ) or 12 weeks post-surgery ( 35·00 vs 38·90 ; p=0·18 ) . Equivalence testing on the difference between the proportion of positive surgical margins between the two groups ( 15 [ 10 % ] in the radical retropubic prostatectomy group vs 23 [ 15 % ] in the robot-assisted laparoscopic prostatectomy group ) showed that e quality between the two techniques could not be established based on a 90 % CI with a Δ of 10 % . However , a superiority test showed that the two proportions were not significantly different ( p=0·21 ) . 14 patients ( 9 % ) in the radical retropubic prostatectomy group versus six ( 4 % ) in the robot-assisted laparoscopic prostatectomy group had postoperative complications ( p=0·052 ) . 12 ( 8 % ) men receiving radical retropubic prostatectomy and three ( 2 % ) men receiving robot-assisted laparoscopic prostatectomy experienced intraoperative adverse events . INTERPRETATION These two techniques yield similar functional outcomes at 12 weeks . Longer term follow-up is needed . In the interim , we encourage patients to choose an experienced surgeon they trust and with whom they have rapport , rather than a specific surgical approach . FUNDING Cancer Council Queensl and In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials Background Prostate cancer is the most common male cancer in the Western world however there is ongoing debate about the optimal treatment strategy for localised disease . While surgery remains the most commonly received treatment for localised disease in Australia more recently a robotic approach has emerged as an alternative to open and laparoscopic surgery . However , high level data is not yet available to support this as a superior approach or to guide treatment decision making between the alternatives . This paper presents the design of a r and omised trial of Robotic and Open Prostatectomy for men newly diagnosed with localised prostate cancer that seeks to answer this question . Methods / design 200 men per treatment arm ( 400 men in total ) are being recruited after diagnosis and before treatment through a major public hospital outpatient clinic and r and omised to 1 ) Robotic Prostatectomy or 2 ) Open Prostatectomy . All robotic prostatectomies are being performed by one surgeon and all open prostatectomies are being performed by one other surgeon . Outcomes are being measured pre-operatively and at 6 weeks and 3 , 6 , 12 and 24 months post-surgery . Oncological outcomes are being related to positive surgical margins , biochemical recurrence + /− the need for further treatment . Non-oncological outcome measures include : pain , physical and mental functioning , fatigue , summary ( preference-based utility scores ) and domain-specific QoL ( urinary incontinence , bowel function and erectile function ) , cancer specific distress , psychological distress , decision-related distress and time to return to usual activities . Cost modelling of each approach , as well as full economic appraisal , is also being undertaken . Discussion The study will provide recommendations about the relative benefits of Robotic and Open Prostatectomy to support informed patient decision making about treatment for localised prostate cancer ; and to assist in treatment services planning for this patient group . Trial registration Background Few studies to date have directly compared outcomes of retropubic ( RRP ) and laparoscopic ( LRP ) radical prostatectomy . We investigated a single institution experience with RRP and LRP with respect to functional and pathological outcomes . Methods 168 patients who underwent RRP were compared to 171 patients who underwent LRP at our institution . Pathological and functional outcomes including postoperative urinary incontinence and erectile dysfunction ( ED ) of the two cohorts were examined . Results Patients had bilateral , unilateral and no nerve sparing technique performed in 83.3 % , 1.8 % and 14.9 % of cases for RRP and 23.4 % , 22.8 % and 53.8 % of cases for LRP , respectively ( p < 0.001 ) . Overall positive surgical margin rates were 22.2 % among patients who underwent RRP compared to 26.5 % of patients who underwent LRP ( p = 0.435 ) . Based upon pads/day , urinary continence postoperatively was achieved in 83.2 % and 82.8 % for RR
Output:
| There is no high- quality evidence to inform the comparative effectiveness of LRP or RARP compared to ORP for oncological outcomes .
Urinary and sexual quality of life-related outcomes appear similar .
Overall and serious postoperative complication rates appear similar .
The difference in postoperative pain may be minimal .
Men undergoing LRP or RARP may have a shorter hospital stay and receive fewer blood transfusions . |
MS213481 | ***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 Survival from acute coronary syndromes and major trauma has been shown to depend on timely access to definitive treatment . We sought to identify the significance of intensive care unit ( ICU ) admission delay ( lead-time ) on the outcome of critically-ill medical patients with other diagnoses . METHODS From 1 January 1997 to 31 December 2003 , a prospect i ve cohort study was performed in critically-ill patients requiring mechanical ventilatory support ( MV ) and /or renal replacement therapy ( RRT ) , admitted directly to the Northern Hospital ICU within 24 hours of arrival in the emergency department ( ED ) . Patients were excluded if , a ) they were admitted following surgery , major trauma or transfer from another hospital , or b ) their duration of ICU stay was < 8 hours . Data collected included de-identified patient demographics , final diagnosis , APACHE II mortality risk ( pm ) and lead-time ( i.e. difference between times of entrance to the ED and ICU . ) The primary outcome measure was hospital discharge status . RESULTS Six hundred and nineteen consecutive ICU admissions from the ED met the inclusion criteria and required MV ( n = 557 ) and /or RRT ( n = 162 . ) Non-survivors were older ( median age 73 vs. 54 yrs ) and sicker ( median pm 0.72 vs. 0.23 ) compared with survivors . Multivariate analysis using logistic regression identified lead-time as a significant predictor of mortality ( RR = 1.06 per hour , 95 % CI = 1.01 - 1.10 ; p=0.015 ) in addition to age , diagnosis and illness severity . CONCLUSIONS ICU admission delay ( lead-time ) is associated with a greater mortality-risk in critically ill medical patients requiring MV and /or RRT Introduction When the number of patients who require intensive care is greater than the number of beds available , intensive care unit ( ICU ) entry flow is obstructed . This phenomenon has been associated with higher mortality rates in patients that are not admitted despite their need , and in patients that are admitted but are waiting for a bed . The purpose of this study is to evaluate if a delay in ICU admission affects mortality for critically ill patients . Methods A prospect i ve cohort of adult patients admitted to the ICU of our institution between January and December 2005 were analyzed . Patients for whom a bed was available were immediately admitted ; when no bed was available , patients waited for ICU admission . ICU admission was classified as either delayed or immediate . Confounding variables examined were : age , sex , originating hospital ward , ICU diagnosis , co-morbidity , Acute Physiology and Chronic Health Evaluation ( APACHE ) II score , therapeutic intervention , and Sequential Organ Failure Assessment ( SOFA ) score . All patients were followed until hospital discharge . Results A total of 401 patients were evaluated ; 125 ( 31.2 % ) patients were immediately admitted and 276 ( 68.8 % ) patients had delayed admission . There was a significant increase in ICU mortality rates with a delay in ICU admission ( P = 0.002 ) . The fraction of mortality risk attributable to ICU delay was 30 % ( 95 % confidence interval ( CI ) : 11.2 % to 44.8 % ) . Each hour of waiting was independently associated with a 1.5 % increased risk of ICU death ( hazard ratio ( HR ) : 1.015 ; 95 % CI 1.006 to 1.023 ; P = 0.001 ) . Conclusions There is a significant association between time to admission and survival rates . Early admission to the ICU is more likely to produce positive outcomes STUDY OBJECTIVE We describe the frequency of undesirable events among patients boarding at a single , urban , tertiary , teaching emergency department ( ED ) through retrospective chart abstract ion . METHODS This was a chart review of all patients admitted during 3 r and omly selected days in 2003 ( n=162 ) to track the frequency of undesirable events such as missed relevant home medications , missed laboratory test results , arrhythmias , or other adverse events . RESULTS One hundred fifty-one charts were abstract ed ( 93.2 % ) ; 27.8 % had an undesirable event , 17.9 % missed a relevant home medication , and 3.3 % had a preventable adverse event . There was a higher frequency of undesirable events among older patients ( 35.9 % , aged > 50 years ; 7.3 % , aged 20 to 49 years ; 28.6 % , aged 0 to 19 years ) and those with more comorbidities ( 44.4 % among Charlson score > or=3 ; 30.8 % score 2 ; 36.1 % score 1 ; 14.5 % score 0 ) . CONCLUSION A substantial frequency of undesirable events occurs while patients board in the ED . These events are more frequent in older patients or those with more comorbidities . Future studies need to compare the rates of undesirable events among patients boarding in the ED versus inpatient units Background The dem and for critical care beds is increasing out of proportion to bed availability . As a result , some critically ill patients are kept in the Emergency Department ( ED boarding ) awaiting bed availability . The aim of our study is to examine the impact of boarding in the ED on the outcome of patients admitted to the Intensive Care Unit(ICU ) . Methods This was a retrospective analysis of ICU data collected prospect ively at King Abdulaziz Medical City , Riyadh from ED between January 2010 and December 2012 and all patients admitted during this time were evaluated for their duration of boarding . Patients were stratified into three groups according to the duration of boarding from ED . Those admitted less than 6 h were classified as Group I , between 6 and 24 h , Group II and more than 24 h as Group III . We carried out multivariate analysis to examine the independent association of boarding time with the outcome adjusting for variables like age , sex , APACHE , Mechanical ventilation , Creatinine , Platelets , INR . Results During the study period , 940 patients were admitted from the ED to ICU , amongst whom 227 ( 25 % ) were admitted to ICU within 6 h , 358 ( 39 % ) within 6–24 h and 355 ( 38 % ) after 24 h. Patients admitted to ICU within 6 h were younger [ 48.7 ± 22.2(group I ) years , 50.6 ± 22.6 ( group II ) , 58.2 ± 20.9 ( group III ) ( P = 0.04)]with less mechanical ventilation duration [ 5.9 ± 8.9 days ( Group I ) , 6.5 ± 8.1 ( Group II ) and 10.6 ± 10.5 ( Group III ) , P = 0.04 ] . There was a significant increase in hospital mortality [ 51(22.5 ) , 104(29.1 ) , 132(37.2 ) , P = 0.0006 ) and the ICU length of stay(LOS ) [ 9.55 days ( Group I ) , 9.8 ( Group II ) and 10.6 ( Group III ) , ( P = 0.002 ) ] with increase in boarding duration . In addition , the delay in admission was an independent risk factor for ICU mortality(OR for group III vs group I is 1.90 , P = 0.04 ) and hospital mortality(OR for group III vs Group I is 2.09 , P = 0.007 ) . Conclusion Boarding in the ED is associated with higher mortality . This data highlights the importance of this phenomenon and suggests the need for urgent measures to reduce boarding and to improve patient flow OBJECTIVE We hypothesized that critically ill patients who remain in the ED for more than 24 hours experience worse outcomes and longer lengths of stay than those transferred to the medical intensive care unit ( MICU ) within 24 hours . METHODS Medical records were examined of all patients admitted to the MICU directly from the ED of a 325-bed community teaching hospital between 2001 and 2002 . RESULTS Of 443 patients , 104 remained in the ED for 24 hours or longer ( ED > or=24 ) before being transferred to the MICU . There were no significant differences in demographic characteristics of the 339 who were in the ED for less than 24 hours ( ED < 24 ) as compared with ED > or=24 . APACHE II scores were 18.9+/-1.0 for a r and om sample of ED<24 and 20.5+/-0.9 for ED > or=24 ( P=.2 ) . Lengths of hospital stay were 10.9+/-0.8 days for ED<24 and 9.8+/-0.9 days for ED > or=24 ( P=.7 ) . Mortality rates were 26.8 % for ED<24 and 26.9 % for ED > or=24 ( P=.5 ) . CONCLUSIONS These data suggest that outcomes of critically ill patients transferred from the ED to our MICU within 24 hours were not better than those who remained in the ED for longer duration s. Larger studies are required to examine this hypothesis OBJECTIVE To assess the impact of delay in emergency department ( ED ) on outcome of critically ill patients admitted to the medical intensive care unit ( MICU ) . Outcome was defined as hospital mortality and as health-related quality of life ( HRQoL ) at 6 months after intensive care assessed by the 15D measure . The 15D is a generic , 15-dimensional , st and ardized measure of HRQoL. We hypothesized that prolonged stay in the ED is related to worse outcome . DESIGN AND SETTING A prospect i ve follow-up cohort study in university hospital . SUBJECTS All consecutive 1675 patients admitted to the MICU between July 2002 and June 2004 . RESULTS The 15D question naire was mailed to all patients alive at 6 months after admission . Of all MICU patients , 64 % were admitted from ED . The mean length of stay in the ED was 6.2 h ( 95%CI 5.9 - 6.5 h ) . The hospital mortality rate was 24.4 % ( 20.0 % in the ED vs. 33.0 % in the non-ED cohort , P < 0.001 ) and it was associated with higher age and degree of physiological derangement at admission . Neither the length of ED stay was associated with hospital mortality ( P = 0.82 ) nor with HRQoL at 6 months after MICU admission ( P = 0.34 ) . Altogether , HRQoL at 6 months was significantly lower compared with the age- and sex-matched general population ( P < 0.001 ) . CONCLUSIONS In a university hospital , the length of ED stay was not associated with the outcome of critically ill medical patients . However , we feel that the effect of ED treatment and delay on outcome and outcome prediction in the critically ill patients deserves further evaluation We hypothesized that a " closed " intensive care unit ( ICU ) was more efficient that an " open " one . ICU admissions were retrospectively analyzed before and after ICU closure at one hospital ; prospect i ve analysis in that ICU with an open ICU nearby was done . Illness severity was gauged by the Mortality Prediction Model ( MPM0 ) . Outcomes included mortality , ICU length of stay ( LOS ) , hospital LOS , and mechanical ventilation ( MV ) . There were no differences in age , MPM0 , and use of MV . ICU and hospital LOS were lower when " closed " ( ICU LOS : prospect i ve 6.1 versus 12.6 d , p < 0.0001 ; retrospective 6.1 versus 9.3 d , p < 0.05 ; hospital LOS : prospect i ve 19.2 versus 33.2 d , p < 0.008 ; retrospective 22.2 versus 31.2 d , p < 0.02 ) . Days on MV were lower when " closed " ( prospect i ve 2.3 versus 8.5 d , p < 0.0005 ; retrospective 3.3 versus 6.4 d , p < 0.05 ) . Pooled data revealed the following : MV predicted ICU LOS ; ICU organization and MPM0 predicted days on MV ; MV and ICU organization predicted hospital LOS ; mortality predictors were open ICU ( odds ratio [ OR ] 1.5 , p < 0.04 ) , MPM0 ( OR 1.16 for MPM0 increase 0.1 , p < 0.002 ) , and MV ( OR 2.43 , p < 0.0001 ) . We conclude that patient care is more efficient with a closed ICU , and that mortality is not adversely affected OBJECTIVES The authors assessed the effect of emergency department ( ED ) crowding on the nontreatment and delay in treatment for analgesia in patients who had acute abdominal pain . METHODS This was a secondary analysis of prospect ively enrolled nonpregnant adult patients presenting to an urban teaching ED with abdominal pain during a 9-month period . Each patient had four vali date d crowding measures assigned at triage . Main outcomes were the administration of and delays in time to analgesia . A delay was defined as waiting more than 1 hour for analgesia . Relative risk ( RR ) regression was used to test the effects of crowding on outcomes . RESULTS A total of 976 abdominal pain patients ( mean [ + /-st and ard deviation ] age = 41 [ + /-16.6 ] years ; 65 % female , 62 % black ) were enrolled , of whom 649 ( 67 % ) received any analgesia . Of those treated , 457 ( 7
Output:
| The last remaining study included both ICU and non-ICU subgroups and showed conflicting results , with a positive association for non-ICU patients but no association for ICU patients .
Our systematic review did not find a strong evidence for the association between ED boarding and IHM but there is a tendency toward this association . |
MS213482 | ***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 . Gastroesophageal reflux disease has been reported to be a common burden on health-care re sources in the Western world , but its manifestations in the general population are as yet unclear . The aim of this study was to estimate the prevalence of , and to identify the risk factors for gastroesophageal reflux symptoms ( GERS ) and erosive esophagitis ( EE ) in the adult population of two Swedish municipalities . Material and methods . A r and om sample ( n=3000 ) of the adult population ( 20–81 years of age ) of two Swedish municipalities ( n=21,610 ) was surveyed using a vali date d postal question naire assessing gastrointestinal symptoms . The response rate was 74 % . A sub sample ( n=1000 ) of the responders was subsequently invited , in r and om order , for esophago-gastro-duodenoscopy with evaluation of GERS , risk factors and tests for Helicobacter pylori . Results . GERS were reported by 40.0 % and EE was found in 15.5 % of the population that had undergone endoscopy . Of those with GERS , 24.5 % had EE while 36.8 % of those with EE reported no GERS . Hiatus hernia and obesity remained significant risk factors for GERS and /or EE , with or without symptoms in a main effect model ( OR up to 14 at EE ) . Those with active H. pylori infection had a higher risk of GERS without EE than those without H. pylori infection ( OR=1.71 ( 1.23–2.38 ) ) . Conclusions . GERS and EE ( of which one-third is asymptomatic ) are highly prevalent in the Swedish adult population . H. pylori infection seems to play a role in the manifestations of gastroesophageal reflux AIM To clarify the association between physical activity and gastroesophageal reflux disease ( GERD ) in non-obese and obese people . METHODS A Swedish population -based cross-sectional survey was conducted . Participants aged 40 - 79 years were r and omly selected from the Swedish Registry of the Total Population . Data on physical activity , GERD , body mass index ( BMI ) and the covariates age , gender , comorbidity , education , sleeping problems , and tobacco smoking were obtained using vali date d question naires . GERD was self-reported and defined as heartburn or regurgitation at least once weekly , and having at least moderate problems from such symptoms . Frequency of physical activity was categorized into three groups : ( 1 ) " high " ( several times/week ) ; ( 2 ) " intermediate " ( approximately once weekly ) ; and ( 3 ) " low " ( 1 - 3 times/mo or less ) . Analyses were stratified for participants with " normal weight " ( BMI < 25 kg/m² ) , " overweight " ( BMI 25 to ≤ 30 kg/m² ) and " obese " ( BMI > 30 kg/m² ) . Multivariate logistic regression was used to calculate odds ratios ( ORs ) with 95 % confidence intervals ( CIs ) , adjusted for potential confounding by covariates . RESULTS Of 6969 eligible and r and omly selected individuals , 4910 ( 70.5 % ) participated . High frequency of physical activity was reported by 2463 ( 50 % ) participants , GERD was identified in 472 ( 10 % ) participants , and obesity was found in 680 ( 14 % ) . There were 226 ( 5 % ) individuals with missing information about BMI . Normal weight , overweight and obese participants were similar regarding distribution of gender and tobacco smoking status , while obese participants were on average slightly older , had fewer years of education , more comorbidity , slightly more sleeping problems , lower frequency of physical activity , and higher occurrence of GERD . Among the 2146 normal-weight participants , crude point estimates indicated a decreased risk of GERD among individuals with high frequency of physical activity ( OR : 0.59 , 95 % CI : 0.39 - 0.89 ) , compared to low frequency of physical activity . However , after adjustment for potential confounding factors , neither intermediate ( OR : 1.30 , 95 % CI : 0.75 - 2.26 ) nor high ( OR : 0.99 , 95 % CI : 0.62 - 1.60 ) frequency of physical activity was followed by decreased risk of GERD . Sleeping problems and high comorbidity were identified as potential confounders . Among the 1859 overweight participants , crude point estimates indicated no increased or decreased risk of GERD among individuals with intermediate or high frequency of physical activity , compared to low frequency . After adjustment for confounding , neither intermediate ( OR : 0.75 , 95 % CI : 0.46 - 1.22 ) nor high frequency of physical activity were followed by increased or decreased risk of GERD compared to low frequency among nonobese participants . Sleeping problems and high comorbidity were identified as potential confounders for overweight participants . In obese individuals , crude ORs were similar to the adjusted ORs and no particular confounding factors were identified . Intermediate frequency of physical activity was associated with a decreased occurrence of GERD compared to low frequency of physical activity ( adjusted OR : 0.41 , 95 % CI : 0.22 - 0.77 ) . CONCLUSION Intermediate frequency of physical activity might decrease the risk of GERD among obese individuals , while no influence of physical activity on GERD was found in non-obese people BACKGROUND Two types of reflux episodes have been identified : upright or daytime and supine or nocturnal . The population -based prevalence of symptoms of nocturnal gastroesophageal reflux disease ( GERD ) and the impact of those symptoms on health-related quality of life ( HRQL ) have not been established . METHODS A national r and om- sample telephone survey was conducted to estimate the prevalence of frequent GERD and nocturnal GERD-like symptoms and to assess the relationship between HRQL , GERD , and nocturnal GERD symptoms . Respondents were classified as controls , subjects with symptomatic nonnocturnal GERD , and subjects with symptomatic nocturnal GERD . The HRQL was assessed using the Medical Outcomes Study Short-Form 36 Health Survey ( SF-36 ) . RESULTS The prevalence of frequent GERD was 14 % , with an overall prevalence of nocturnal GERD of 10 % . Seventy-four percent of those with frequent GERD symptoms reported nocturnal GERD symptoms . Subjects with nonnocturnal GERD had significant decrements on the SF-36 physical and mental component summary scores compared with the US general population . Subjects reporting nocturnal GERD symptoms were significantly more impaired than subjects reporting nonnocturnal GERD symptoms on both the physical component summary ( 38.94 vs 41 . 52 ; P<.001 ) and mental component summary ( 46.78 vs 49.51 ; P<.001 ) and all 8 subscales of the SF-36 ( P<.001 ) . Subjects with nocturnal GERD demonstrated considerable impairment compared with the US general population and chronic disease population s. Subjects with nocturnal GERD had significantly more pain than those with hypertension and diabetes ( P<.001 ) and similar pain compared with those with angina and congestive heart failure . CONCLUSIONS Nocturnal symptoms are commonly experienced by individuals who report frequent GERD symptoms . In addition , HRQL is significantly impaired in those persons who report frequent GERD symptoms , and HRQL impairment is exacerbated in those who report nocturnal GERD symptoms Symptoms suggestive of gastro-oesophageal reflux disease are very common . The aim of the study was to assess the prevalence of these symptoms and factors influencing them in an unselected adult population . A question naire was mailed to a r and om sample of 2500 people aged > or = 20 years . The questions concerned heartburn , regurgitation , dysphagia , chest and upper abdominal pain , as well as medication and medical consultations for these symptoms . Of the 1700 ( 68 % ) responders , 9 % had experienced heartburn on the day of response and 15 % , 21 % and 27 % during the preceding week , month and year , respectively . The corresponding figures for regurgitation were 5 , 15 , 29 and 45 % . During the past year 43 % of the study group had had no such symptoms . Age , overweight , pregnancy and cigarette smoking significantly influenced the prevalence of symptoms . Using daily heartburn and /or regurgitation as dominant indicators 10.3 % ( 95 % CI 12 - 11.7 ) of the responders had gastro-oesophageal reflux disease . Medication ( most commonly antacids ) was used by only 16 % of the symptomatic people , and only 5.5 % had sought medical advice for symptoms during the past year . Thus , despite commonness of symptoms suggestive of gastro-oesophageal reflux disease only a minority of the individuals suffering from such symptoms use medication or have medical consultation BACKGROUND The prevalence of gastroesophageal reflux disease ( GERD ) in Asian population s is reported to be lower than that in the West . Population -based data on the prevalence and symptom profile of GERD in developing Caucasian countries is lacking . Our objective was to determine the prevalence of gastrointestinal symptoms and clinical spectrum of GERD in Tehran , northern Iran and their association with patient characteristics . METHODS One thous and seven hundred telephone numbers were r and omly selected from Tehran telephone directory using a simple r and om method . A two-step screening telephone survey was then performed . In each answered call a second rapid survey was done to select a subject 18 - 65 years old from that household . A vali date d question naire was then filled out for that individual . Patient characteristics ( age , education , and gender ) and history of acid regurgitation and heartburn during the last week , as well as the previous three months were inquired about . RESULTS Of the 1,700 selected numbers , 278 either did not answer or did not have an eligible case ; 220 refused to participate . A total of 1,202 subjects ( 42 % males , mean age : 36 years , range : 18 - 65 yr ) were surveyed . The prevalence of heartburn occurring monthly , weekly , and daily was 4.7 % ( CI95 % : 3.5 - 6.0 % ) , 1.6 % ( CI95 % : 1.0 - 2.5 % ) , and 0.6 % ( CI95 % : 0.3 - 1.3 % ) , respectively . The corresponding figures for acid regurgitation were 15.6 % ( CI95 % : 13.6 - 17.7 % ) , 5.7 % ( CI95 % : 4.4 - 7.1 % ) and 1.5 % ( CI95 % : 0.9 - 2.4 % ) , respectively . The prevalence of GERD , defined as heartburn and /or acid regurgitation experienced daily , weekly and monthly was 1.9 % ( CI95 % : 1.2 - 2.9 % ) , 6.8 % ( CI95 % : 5.4 - 8.3 % ) , and 18.4 % ( CI95 % : 16.2 - 20.6 % ) . There was no relationship between the prevalence of GERD and either gender , age , or education . CONCLUSION Monthly GERD symptoms occur in 18.4 % of the general population in Tehran . Acid regurgitation is more common ( 4 - 5 times ) than heartburn . Gender , age , and level of education do not affect the prevalence of GERD symptoms in the community studied Background We aim ed to determine the prevalence of gastroesophageal reflux disease ( GERD ) and associated risk factors , and assess quality of life ( QoL ) in relation to the frequency and severity of reflux symptoms . Methods A r and om sample of 1000 residents of Western Sydney were mailed a vali date d self-report question naire . GERD symptoms , risk factors , psychologic distress , QoL , and demographics were measured . Results The response rate was 73 % ( n=672 ; mean age , 46 y ; 52 % female ) . A total of 78 [ 12 % , 95 % confidence interval ( CI ) : 9 - 14 ] had GERD ( at least weekly heartburn and /or acid regurgitation ) . Independent risk factors for GERD were high cholesterol [ odds ratio ( OR ) = 3.28 , 95 % CI : 1.42 - 7.57 , P=0.005 ] and current smoker ( OR=2.47 , 95 % CI : 1.07 - 5.70 , P=0.03 ) . Anxiety , depression , and neuroticism were not risk factors . Worse physical functioning was the only QoL domain associated with GERD ( OR=0.98 , 95 % CI : 0.97 - 0.99 , P=0.006 ) . QoL was significantly impaired regardless of the severity of GERD for the QoL domains physical function , body pain , vitality , and social function . The frequency of heartburn and acid regurgitation were not associated with significantly reduced QoL domain scores . Conclusions Cardiac risk factors ( high cholesterol and smoking ) were independently associated with GERD . Increasing GERD symptom severity is associated with worse Q
Output:
| Conclusions The prevalence of gastro-oesophageal reflux symptoms varied strikingly among countries , even when similar definitions were used to define their presence .
Prevalence was significantly higher in subjects ≥50 years , smokers , NSAID users and obese individuals , although these associations were modest |
MS213483 | ***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 sensory and motor functioning of normal children ( N = 119 ) ages 4 to 13 years old were examined for developmental and sex differences in relation to neuropsychological functioning . Sensory and motor subtests of the Dean-Woodcock Neuropsychological Assessment System ( D-WNAS ) , a st and ardized instrument , were administered . Significant differences between the older and younger children were found , suggesting that developmental differences exist for sensory and motor functioning . The older children significantly outperformed the younger children on all subtests except for visual confrontation . Differences between males and females and the interaction between sex and age were not significant . The present findings coincide with previous research showing clear maturational differences in sensory and motor functions Background Neuromuscular training may reduce risk factors that contribute to ACL injury incidence in female athletes . Multi-component , ACL injury prevention training programs can be time and labor intensive , which may ultimately limit training program utilization or compliance . The purpose of this study was to determine the effect of neuromuscular training on those classified as " high-risk " compared to those classified as " low-risk . " The hypothesis was that high-risk athletes would decrease knee abduction moments while low-risk and control athletes would not show measurable changes . Methods Eighteen high school female athletes participated in neuromuscular training 3 × /week over a 7-week period . Knee kinematics and kinetics were measured during a drop vertical jump ( DVJ ) test at pre/post training . External knee abduction moments were calculated using inverse dynamics . Logistic regression indicated maximal sensitivity and specificity for prediction of ACL injury risk using external knee abduction ( 25.25 Nm cutoff ) during a DVJ . Based on these data , 12 study subjects ( and 4 controls ) were grouped into the high-risk ( knee abduction moment > 25.25 Nm ) and 6 subjects ( and 7 controls ) were grouped into the low-risk ( knee abduction < 25.25 Nm ) categories using mean right and left leg knee abduction moments . A mixed design repeated measures ANOVA was used to determine differences between athletes categorized as high or low-risk . Results Athletes classified as high-risk decreased their knee abduction moments by 13 % following training ( Dominant pre : 39.9 ± 15.8 Nm to 34.6 ± 9.6 Nm ; Non-dominant pre : 37.1 ± 9.2 to 32.4 ± 10.7 Nm ; p = 0.033 training X risk factor interaction ) . Athletes grouped into the low-risk category did not change their abduction moments following training ( p > 0.05 ) . Control subjects classified as either high or low-risk also did not significantly change from pre to post-testing . Conclusion These results indicate that " high-risk " female athletes decreased the magnitude of the previously identified risk factor to ACL injury following neuromuscular training . However , the mean values for the high-risk subjects were not reduced to levels similar to low-risk group following training . Targeting female athletes who demonstrate high-risk knee abduction loads during dynamic tasks may improve efficacy of neuromuscular training . Yet , increased training volume or more specific techniques may be necessary for high-risk athletes to substantially decrease ACL injury risk Abstract . The development of proprioceptive sensitivity was studied in 140 children between the ages of 5.8 and 11.8 years using a so-called foot-h and task . Ten boys and ten girls were included in each age group . The task required the children to locate a target pin with the " big toe " ( felt target ) and match the located target position with the h and , without vision . There were four conditions : location of targets by the right big toe : matching located target position with the right h and ( RfRh ) and left h and ( RfLh ) ; and location of targets by the left big toe : matching located target position with the left h and ( LfLh ) and right h and ( LfRh ) . The results showed a significant developmental trend in proprioceptive sensitivity , when the absolute error scores for boys and girls were combined , with most of the improvement occurring between the ages of 5.8 and 7.8 years . The most interesting and novel finding seems to be the significant two-way interaction between age and sex – the clearest differences manifesting themselves in the age group 9.9 years . Separate within-sex group analyses showed the trend to be determined by the results for the girls , the trend being absent in the results for the boys . Furthermore only the boys showed a significant difference between the intra- and inter-hemispheric conditions . We propose that these differences may only manifest themselves in particular tasks , i.e. there may be a sex-task interaction . The implication s of this proposal for theoretical interpretations of the phenomenon of inter-hemispheric processing as well as possible sources of the task differences are briefly discussed To identify sex differences and developmental trends in motor performance and coordination across three stages of development : prepubertal , pubertal and postpubertal , 60 participants , 30 males and 30 females , were assessed on 13 motor tasks . Physical characteristics that accompany puberty were used to classify the participants into the stages . Analysis of variance and covariate analyses demonstrated that motor performance improves throughout adolescence in both males and females and that sex differences exist in motor performance , males performing better than females . The magnitude of the stage and sex differences were demonstrated by large effect sizes ( eta 2 ) . The motor tasks of long jump , running speed , and throwing a ball principally distinguished between the males and females . Female performance differed less from male performance after puberty . Results showed OBJECTIVE To investigate the developmental trajectory of response inhibition and , more specifically , whether there is a dissociation of function in the prefrontal cortex over the course of development of executive function and associated response inhibition abilities . METHOD Nineteen typically developing subjects , ranging in age from 8 to 20 , performed a Go/NoGo task while behavioral and functional magnetic resonance imaging ( fMRI ) data were collected . RESULTS All subjects performed the task with few errors of omission and commission . No relationship between accuracy and age emerged , but the ability to inhibit responses significantly improved with age . Analyses of fMRI data revealed a positive correlation between activation and age in the left inferior frontal gyrus/insula/orbitofrontal gyrus , and a negative correlation between activation and age in the left middle/superior frontal gyri . CONCLUSION These data provide the first evidence of dissociable processes occurring in the prefrontal cortex during development of executive functions associated with response inhibition : ( 1 ) Younger subjects activate more extensively than older subjects in discrete regions of the prefrontal cortex , presumably due to increased dem and s and inefficient recruitment of brain regions subserving executive functions including working memory . ( 2 ) Older subjects show increasingly focal activation in specific regions thought to play a more critical role in response inhibition In very young children , immature control of posture and gait results in unsteady locomotion . In children of approximately 3 yr of age , gait appears relatively mature ; however , it is unknown whether the dynamics of walking change beyond this age . Because stride dynamics depend on neural control , we hypothesized that motor control would continue to develop beyond age 3 . To test this hypothesis , we measured the gait cycle duration on a stride-by-stride basis in 50 healthy 3- to 14-yr-old children ( 25 girls ) . Measurements of stride-to-stride variability were significantly larger both in the 3- and 4-yr-old children , compared with the 6- and 7-yr-old children , and in the 6- and 7-yr-old children , compared with the 11- to 14-yr-old children . Measurements of the temporal organization of gait also revealed significant age-dependent changes . The effects of age persisted even after adjusting for height . These findings indicate that mature stride dynamics may not be completely developed even in healthy 7-yr-old children and that different aspects of stride dynamics mature at different ages This study presents a method to quantify a child ’s sensitivity to passive limb motion , which is an important aspect of kinaesthesia not easily examined clinical ly . Psychophysical detection thresholds to passive forearm motion were determined in a group of 20 typically developing pre‐adolescent children ( mean age 12y 6mo , SD 10mo , range 11−13y ) and a group of 10 healthy adults ( mean age 29y 10mo , SD 10y 7mo , range 18−50y ) . A newly design ed passive motion apparatus was used to measure the time to detection of forearm motion and the errors in determining movement direction . Results showed that limb motion sensitivity became increasingly variable below 0.3 ° /s in children and adults . In comparison with adults , movement detection times in the pediatric group were increased by between 4 % and 108 % for the range of tested velocities ( 0.075−1.35 ° /s ) . At 0.075 ° /s , 5 % of the children , but 50 % of the adults , made no directional error , indicating that motion perception became unreliable at such low velocity in both groups . The findings demonstrate that sensitivity to passive forearm motion in children should be tested at a range between 0.075 and 0.3 ° /s . They further suggest that passive motion sensitivity may not be fully developed in pre‐adolescent children Prevailing theories of implicit or unaware learning propose a developmental invariance model , with implicit function maturing early in infancy or childhood despite prolonged improvements in explicit or intentional learning and memory systems across childhood . Neuroimaging studies of adult visuomotor sequence learning have associated fronto-striatal brain regions with implicit learning of spatial sequences . Given evidence of continued development in these brain regions during childhood , we compare implicit sequence learning in adults and 7- to 11-year-old children to examine potential developmental differences in the recruitment of fronto-striatal circuitry during implicit learning . Participants performed a st and ard serial reaction time task . Stimuli alternately followed a fixed 10-step sequence of locations or were presented in a pseudor and om order of locations . Adults outperformed children , achieving a significantly larger sequence learning effect and showing learning more quickly than children . Age-related differences in activity were observed in the premotor cortex , putamen , hippocampus , inferotemporal cortex , and parietal cortex . We observed differential recruitment of cortical and subcortical motor systems between groups , presumably reflecting age differences in motor response execution . Adults showed greater hippocampal activity for sequence trials , whereas children demonstrated greater signal during r and om trials . Activity in the right cau date correlated significantly with behavioral measures of implicit learning for both age groups , although adults showed greater signal change than children overall , as would be expected given developmental differences in sequence learning magnitude . These results challenge the idea of developmental invariance in implicit learning and instead support a view of parallel developments in implicit and explicit learning systems Recent research using measures to assess the time-dependent structure of postural fluctuations has provided new insights into the stability and adaptability of human postural control in adults . To date , little research has examined how postural dynamics reflecting the stability and adaptability of postural control may change as a function of development , especially during supra-postural tasks . The goal of this study was to examine the dynamics of postural fluctuations during a manual-fitting task in which precision , visual and postural task constraints were altered in children and adults . Three age groups were tested : 7- , 10-year olds and college aged adults . Recurrence quantification analysis ( RQA ) was used to assess the regularity ( percent determinism ) and complexity ( entropy ) of the center of pressure ( CoP ) in the anterior – posterior ( AP ) and medial-lateral ( ML ) directions . The CoP patterns exhibited by adults were more deterministic and more complex ( higher entropy ) than those of the 7-year-old children under the different experimental manipulations . No differences between the adults and the 10-year-old children were observed . The increase in determinism with a corresponding increase in entropy exhibited by the adults and older-children during a manual fitting task may be a prospect i ve mechanism over which postural movements follow a more predictable path allowing for stable and flexible task performance . Our results also support the notion that complex postural fluctuations ( as measured by RQA entropy ) are functional and typically increase as the precision requirements of a manual task increase Past research has shown that spectral frequency characteristics of a balance control system may be useful for early detection of minor changes in the system . Since there is a lack of information regarding the frequency spectrum of children 's balance control system , this study was undertaken to investigate and compare the spectral frequency characteristics of st and ing balance control between children and young adults under altered sensory environments . Seventeen children ( 9 females , 8 males , mean age 7.8+/-0.9 years ) and the same number of female and male young adults ( mean age 21.1+/-1.3 years ) were tested for st and ing balance under six sensory conditions . These conditions were created by crossing the three levels of the visual factor ( open eye , closed eye , sway-referenced vision ) with the two levels of the somatosensory factor ( fixed foot support , compliant foot support ) . The median spectral frequencies of the shear forces in the anterior-posterior ( A/P ) and the medial-lateral ( M/L ) directions were used as dependent variables . The results showed that children had higher median spectral frequency of the A/P shear force than young adults and this difference was not affected by the somatosensory factor . The median spectral frequency in the M/L direction was not different between the groups . The higher rate of body mass vibration of children in the A/P direction implies that children may not have fully developed the ankle strategy for maintaining st and ing balance , but nonetheless have developed the same efficiency of using vision for their reference of st and ing balance Traditional posturographic analysis and four statistical mechanics techniques were applied to center-of-pressure ( COP ) trajectories of young , older " low-fall-risk " and older " high-fall-risk " individuals . Low-fall-risk older adults were active 3 days per week in a cardiac rehabilitation program , while high-fall-risk older adults were diagnosed with perilymph fistula . Subject
Output:
| The search results indicated that many aspects of sensorimotor function continue to mature throughout adolescence , and at least some children experience delays or regressions in at least some sensorimotor mechanisms . |
MS213484 | ***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: Recent work suggests that plant sterol ( PS ) consumption may lower triglyceride ( TG ) concentrations ; however , human clinical trial evidence is inconsistent . We associated SNP r5882 in cholesteryl ester transfer protein with changes in TG concentrations following PS consumption ( 2 g/day for 4 weeks ) in a dual-centre , single-blind , r and omized , crossover trial . TG concentrations were lowered in homozygotes for the minor G-allele of rs5882 ( -0.46 ± 0.13 mmol/L , p = 0.002 , n = 10 ) ; there was no effect in the A-allele carriers Background —Recent trial data have challenged the hypothesis that cholesteryl ester transfer protein ( CETP ) and high-density lipoprotein cholesterol ( HDL-C ) have causal roles in atherothrombosis . One method to evaluate this issue is to examine whether polymorphisms in the CETP gene that impact on HDL-C levels also impact on the future development of myocardial infa rct ion . Methods and Results —In a prospect i ve cohort of 18 245 initially healthy American women , we examined over 350 000 singe-nucleotide polymorphisms ( SNPs ) first to identify loci associated with HDL-C and then to evaluate whether significant SNPs within these loci also impact on rates of incident myocardial infa rct ion during an average 10-year follow-up period . Nine loci on 9 chromosomes had 1 or more SNPs associated with HDL-C at genome-wide statistical significance ( P<5 × 10−8 ) . However , only SNPs near or in the CETP gene at 16q13 were associated with both HDL-C and risk of incident myocardial infa rct ion ( 198 events ) . For example , SNP rs708272 in the CETP gene was associated with a per-allele increase in HDL-C levels of 3.1 mg/dL and a concordant 24 % lower risk of future myocardial infa rct ion ( age-adjusted hazard ratio , 0.76 ; 95 % CI , 0.62 to 0.94 ) , consistent with recent meta- analysis . Independent and again concordant effects on HDL-C and incident myocardial infa rct ion were also observed at the CETP locus for rs4329913 and rs7202364 . Adjustment for HDL-C attenuated but did not eliminate these effects . Conclusion —In this prospect i ve cohort of initially healthy women , SNPs at the CETP locus impact on future risk of myocardial infa rct ion , supporting a causal role for CETP in atherothrombosis , possibly through an HDL-C mediated pathway Fruit and vegetables are key elements of a cardioprotective diet , but benefits on plasma lipids , especially HDL-cholesterol ( HDL-C ) , are inconsistent both within and between studies . In the present study , we investigated whether four selected HDL-C-related polymorphisms ( cholesteryl ester transfer protein ( CETP ) Taq1B , APOA1 - 75G/A , hepatic lipase ( LIPC ) - 514C → T , and endothelial lipase ( LIPG ) I24582 ) modulate the plasma lipid response to a kiwifruit intervention . This is a retrospective analysis of data collected during a 12-week r and omised controlled cross-over trial . A total of eighty-five hypercholesterolaemic men completed a 4-week healthy diet run-in period before being r and omised to one of two 4-week intervention sequences of two green kiwifruit/d plus healthy diet ( kiwifruit intervention ) or healthy diet alone ( control intervention ) . The measurement of anthropometric parameters and collection of fasting blood sample s were carried out at baseline 1 and after the run-in ( baseline 2 ) and intervention periods . At baseline 2 , B1/B1 homozygotes of the CETP Taq1B gene had significantly higher total cholesterol : HDL-C , TAG : HDL-C , and apoB : apoA1 ratios and small-dense LDL concentrations than B2 carriers . A significant CETP Taq1B genotype × intervention interaction was observed for the TAG : HDL-C ratio ( P= 0·03 ) . B1/B1 homozygotes had a significantly lower TAG : HDL-C ( - 0·23 ( sd 0·58 ) mmol/l ; P= 0·03 ) ratio after the kiwifruit intervention than after the control intervention , whereas the ratio of B2 carriers was not affected . The lipid response was not affected by other gene polymorphisms . In conclusion , the significant decrease in the TAG : HDL-C ratio in B1/B1 homozygotes suggests that regular inclusion of green kiwifruit as part of a healthy diet may improve the lipid profiles of hypercholesterolaemic men with this genotype There are no definitive explanations as to why individuals with hypercholesterolemia , a major cardiovascular risk factor , respond differently to dietary change . Fifty five free-living individuals completed a double crossover trial with two dietary regimens , a high saturated fat diet ( providing 21 % energy from saturated fat and 3 % energy from polyunsaturated fat ) and a high polyunsaturated fat diet ( providing 11 % energy as saturated fat and 10 % energy as polyunsaturated fat ) , each phase continuing for 4 weeks . Extensive genotyping and several measures of dietary compliance have provided further insights regarding the determinants of extent of cholesterol response to changes in the nature of dietary fat . Individuals with the CETP B1B1 genotype and the LPL X447 + allele showed an average 0 . 44 ( 95 % CI : 0.22 , 0.66 ) and 0.45 ( 95 % CI : 0.18 , 0.72 ) mmol/l greater change in total cholesterol , respectively , than those with one or more CETP B2 allele or homozygous for the LPL S447 allele when comparing diets high and low in saturated fat . Indices of dietary compliance including changes in reported saturated and polyunsaturated fat intake and change in triglyceride linoleate were not significantly different between the CETP genotypes . Change in reported saturated ( r=0.36 , P=0.04 ) and polyunsaturated ( r=0.22 , P=0 . 05 ) fat intake and change in triglyceride linoleate ( reflecting polyunsaturated fat intake ) ( r=0.21 , P=0.07 ) , also predicted total cholesterol response to dietary fat changes . In multivariate analyses , variation in the cholesterol ester transfer protein and lipoprotein lipase genes predicted response independent of measures of dietary compliance , suggesting that these two genes are important determinants of variation in cholesterol response to dietary change in free-living individuals Little is known about whether cholesteryl ester transfer protein ( CETP ) genetic variation may modify the effect of weight-loss diets varying in fat content on changes in lipid levels . We analyzed the interaction between the CETP variant rs3764261 and dietary interventions on changes in lipid levels among 732 overweight/obese adults from a 2 year r and omized weight-loss trial [ Preventing Overweight Using Novel Dietary Strategies ( POUNDS LOST ) ] , and replicated the findings in 171 overweight/obese adults from an independent 2 year weight-loss trial [ Dietary Intervention R and omized Controlled Trial ( DIRECT ) ] . In the POUNDS LOST , participants with the CETP rs3764261 CC genotype on the high-fat diet had larger increases in HDL cholesterol ( P = 0.001 ) and decreases in triglycerides ( P = 0.007 ) than those on the low-fat diet at 6 months , while no significant difference between these two diets was observed among participants carrying other genotypes . The gene-diet interactions on changes in HDL-cholesterol and triglycerides were replicated in the DIRECT ( pooled P for interaction ≤ 0.01 ) . Similar results on trajectory of changes in HDL cholesterol and triglycerides over the 2 year intervention were observed in both trials . Our study provides replicable evidence that individuals with the CETP rs3764261 CC genotype might derive greater effects on raising HDL cholesterol and lowering triglycerides by choosing a low-carbohydrate/high-fat weight-loss diet instead of a low-fat diet We examined the relationships of I405V cholesteryl ester transfer protein ( CETP ) , Taq1B CETP and apolipoprotein (apo)E polymorphisms with the pattern of response to dietary plant sterol ester ( PSE ) by plasma lipids and CETP concentrations as well as lecithin-cholesterol acyltransferase ( LCAT ) activity . Subjects with moderate primary hypercholesterolemia ( 20 - 60 y old ; 50 women ; 10 men ) consumed margarine ( 20 g/d ) without ( placebo ) or with PSE ( 2.8 g/d = 1.68 g/d phytosterols ) for 4 wk each period , in a crossover , double-blind study . Plasma CETP concentration was measured by ELISA ; endogenous LCAT activity was expressed as the percentage of esterification ( 30 min incubation ) of the subjects ' (14)C-unesterified cholesterol HDL . PSE reduced concentrations of plasma total cholesterol ( TC ) ( 10 % ) and LDL cholesterol ( LDL-C ) ( 12 % ) . In relation to the I405V CETP polymorphism , the percentage reductions in TC with consumption of PSE for the II , IV and VV phenotypes were 7.2 , 4.2 and not significant , respectively , whereas LDL-C significant reductions occurred only for II ( 9.5 % ) . However , the CETP concentration diminished only in the II phenotype The possible role of four c and i date genes in lipid and lipoprotein response to diet was examined in 214 members of two large kibbutz settlements in Israel . Four site polymorphisms ( signal peptide insertion/deletion , XbaI , EcoRI and MspI ) of the apo B gene , the common apo E genotypes , three common mutations ( T-93 G , S447stop and N291S ) of the LPL gene and the CETP I405V RFLP were determined . The average reduction induced by diet in participants with the absence of the EcoRI restriction site ( L4154 ) of the apo B gene compared with those found to be homozygotes for the restriction site ( G/G4154 ) were : 16.2 and 8.0 mg/dl for total cholesterol ( TC ) ( P=0 . 01 ) ; and 15.6 and 6.2 mg/dl for LDL-C ( P=0.007 ) , respectively . TC and LDL-C baseline levels were significantly different among the apo-E genotypes , yet there were no significant effects on lipid and lipoprotein dietary response . Triglyceride baseline values were significantly lower ( P=0.007 ) among subjects with the LPL S447stop mutation and HDL-C was significantly lower ( P=0.008 ) among subjects found to be heterozygous for the LPL N291S mutation . A heterogeneous response for triglyceride was observed for individuals with the S291 allele as compared to those individuals who were found to be homozygous for the N291 allele . No differences in dietary responsiveness were observed among the apo E and CETP genotypes . In conclusion , our results suggest that sequence variation(s ) in the coding region of the apo B gene linked to the EcoRI polymorphism are associated with total cholesterol and LDL-C responsiveness to dietary manipulation . In our study population , LPL mutations had a significant effect on TG and HDL-C baseline levels and on their response to diet Cholesteryl ester transfer protein ( CETP ) , as a c and i date gene for dyslipoproteinemia and coronary heart disease , was studied in 105 men with low plasma concentrations of high density lipoprotein cholesterol ( HDL-C ) and established coronary heart disease as well as in 515 r and omly selected men and women . A one-nucleotide substitution ( G to A ) in exon 15 , which changes arginine ( 451 ) to glutamine in CETP protein , was detected by PCR-SSCP and direct sequencing and screened in the population sample by a simple PCR-based restriction assay . In the r and om population sample the allele frequency of the R451Q mutation was 1.9 % . Men heterozygous for the R451Q mutation ( n = 7 ) had 27 % higher CETP activity than age- , body mass index- , smoking- and alcohol consumption-matched controls with normal genotype ( n = 21 ; P = 0.003 ) . Women heterozygous for the R451Q mutation ( n = 7 ) had 16 % lower total cholesterol compared to matched controls ( n = 21 ; P = 0.07 ) , but no such difference was detected in men . In the r and om population sample the correlation between plasma total cholesterol level
Output:
| Among CETP variants , the rs9989419 best represented this genome wide association signal across all population s , based on LD r2 estimates from 1000 genomes references .
Regarding the rs708272 ( Taq1B ) , individuals with the B1 risk allele showed better responses to dietary interventions than those with B2B2 genotype , whereas with I405V , inconsistent results have been reported .
Modest alcohol consumption was associated with decreased risk of coronary heart disease among B2 carriers of rs708272.It is concluded that variations in the CETP gene may modulate the effects of dietary components on metabolic traits . |
MS213485 | ***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 British Regional Heart Study ( BRHS ) reported in 1986 that much of the inverse relation of high-density lipoprotein cholesterol ( HDLC ) and incidence of coronary heart disease was eliminated by covariance adjustment . Using the proportional hazards model and adjusting for age , blood pressure , smoking , body mass index , and low-density lipoprotein cholesterol , we analyzed this relation separately in the Framingham Heart Study ( FHS ) , Lipid Research Clinics Prevalence Mortality Follow-up Study ( LRCF ) and Coronary Primary Prevention Trial ( CPPT ) , and Multiple Risk Factor Intervention Trial ( MRFIT ) . In CPPT and MRFIT ( both r and omized trials in middle-age high-risk men ) , only the control groups were analyzed . A 1-mg/dl ( 0.026 mM ) increment in HDLC was associated with a significant coronary heart disease risk decrement of 2 % in men ( FHS , CPPT , and MRFIT ) and 3 % in women ( FHS ) . In LRCF , where only fatal outcomes were documented , a 1-mg/dl increment in HDLC was associated with significant 3.7 % ( men ) and 4.7 % ( women ) decrements in cardiovascular disease mortality rates . The 95 % confidence intervals for these decrements in coronary heart and cardiovascular disease risk in the four studies overlapped considerably , and all contained the range 1.9 - 2.9 % . HDLC levels were essentially unrelated to non-cardiovascular disease mortality . When differences in analytic methodology were eliminated , a consistent inverse relation of HDLC levels and coronary heart disease event rates was apparent in BRHS as well as in the four American studies BACKGROUND In observational analyses , higher levels of high-density lipoprotein ( HDL ) cholesterol have been associated with a lower risk of coronary heart disease events . However , whether raising HDL cholesterol levels therapeutically reduces cardiovascular risk remains uncertain . Inhibition of cholesteryl ester transfer protein ( CETP ) raises HDL cholesterol levels and might therefore improve cardiovascular outcomes . METHODS We r and omly assigned 15,871 patients who had had a recent acute coronary syndrome to receive the CETP inhibitor dalcetrapib , at a dose of 600 mg daily , or placebo , in addition to the best available evidence -based care . The primary efficacy end point was a composite of death from coronary heart disease , nonfatal myocardial infa rct ion , ischemic stroke , unstable angina , or cardiac arrest with resuscitation . RESULTS At the time of r and omization , the mean HDL cholesterol level was 42 mg per deciliter ( 1.1 mmol per liter ) , and the mean low-density lipoprotein ( LDL ) cholesterol level was 76 mg per deciliter ( 2.0 mmol per liter ) . Over the course of the trial , HDL cholesterol levels increased from baseline by 4 to 11 % in the placebo group and by 31 to 40 % in the dalcetrapib group . Dalcetrapib had a minimal effect on LDL cholesterol levels . Patients were followed for a median of 31 months . At a prespecified interim analysis that included 1135 primary end-point events ( 71 % of the projected total number ) , the independent data and safety monitoring board recommended termination of the trial for futility . As compared with placebo , dalcetrapib did not alter the risk of the primary end point ( cumulative event rate , 8.0 % and 8.3 % , respectively ; hazard ratio with dalcetrapib , 1.04 ; 95 % confidence interval , 0.93 to 1.16 ; P=0.52 ) and did not have a significant effect on any component of the primary end point or total mortality . The median C-reactive protein level was 0.2 mg per liter higher and the mean systolic blood pressure was 0.6 mm Hg higher with dalcetrapib as compared with placebo ( P<0.001 for both comparisons ) . CONCLUSIONS In patients who had had a recent acute coronary syndrome , dalcetrapib increased HDL cholesterol levels but did not reduce the risk of recurrent cardiovascular events . ( Funded by F. Hoffmann-La Roche ; dal- OUTCOMES Clinical Trials.gov number , NCT00658515 . ) Background — There is no r and omized , double-blind trial testing the prognostic effect of highly purified omega-3 fatty acids in addition to current guideline -adjusted treatment of acute myocardial infa rct ion . Methods and Results — OMEGA is a r and omized , placebo-controlled , double-blind , multicenter trial testing the effects of omega-3-acid ethyl esters-90 ( 1 g/d for 1 year ) on the rate of sudden cardiac death in survivors of acute myocardial infa rct ion , if given in addition to current guideline -adjusted treatment . Secondary end points were total mortality and nonfatal clinical events . Patients ( n=3851 ; female , 25.6 % ; mean age , 64.0 years ) were r and omized in 104 German centers 3 to 14 days after acute myocardial infa rct ion from October 2003 until June 2007 . Acute coronary angiography was performed in 93.8 % and acute percutaneous coronary intervention in 77.8 % of all patients . During a follow-up of 365 days , the event rates were ( omega and control groups ) as follows : sudden cardiac death , 1.5 % and 1.5 % ( P=0.84 ) ; total mortality , 4.6 % and 3.7 % ( P=0.18 ) ; major adverse cerebrovascular and cardiovascular events , 10.4 % and 8.8 % ( P=0.1 ) ; and revascularization in survivors , 27.6 % and 29.1 % ( P=0.34 ) . Conclusions — Guideline -adjusted treatment of acute myocardial infa rct ion results in a low rate of sudden cardiac death and other clinical events within 1 year of follow-up , which could not be shown to be further reduced by the application of omega-3 fatty acids . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00251134 BACKGROUND Epidemiological and clinical evidence suggests that an increased intake of long-chain n-3 fatty acids protects against mortality from coronary artery disease . We aim ed to test the hypothesis that long-term use of eicosapentaenoic acid ( EPA ) is effective for prevention of major coronary events in hypercholesterolaemic patients in Japan who consume a large amount of fish . METHODS 18 645 patients with a total cholesterol of 6.5 mmol/L or greater were recruited from local physicians throughout Japan between 1996 and 1999 . Patients were r and omly assigned to receive either 1800 mg of EPA daily with statin ( EPA group ; n=9326 ) or statin only ( controls ; n=9319 ) with a 5-year follow-up . The primary endpoint was any major coronary event , including sudden cardiac death , fatal and non-fatal myocardial infa rct ion , and other non-fatal events including unstable angina pectoris , angioplasty , stenting , or coronary artery bypass grafting . Analysis was by intention-to-treat . The study was registered at Clinical Trials.gov , number NCT00231738 . FINDINGS At mean follow-up of 4.6 years , we detected the primary endpoint in 262 ( 2.8 % ) patients in the EPA group and 324 ( 3.5 % ) in controls-a 19 % relative reduction in major coronary events ( p=0.011 ) . Post-treatment LDL cholesterol concentrations decreased 25 % , from 4.7 mmol/L in both groups . Serum LDL cholesterol was not a significant factor in a reduction of risk for major coronary events . Unstable angina and non-fatal coronary events were also significantly reduced in the EPA group . Sudden cardiac death and coronary death did not differ between groups . In patients with a history of coronary artery disease who were given EPA treatment , major coronary events were reduced by 19 % ( secondary prevention subgroup : 158 [ 8.7 % ] in the EPA group vs 197 [ 10.7 % ] in the control group ; p=0.048 ) . In patients with no history of coronary artery disease , EPA treatment reduced major coronary events by 18 % , but this finding was not significant ( 104 [ 1.4 % ] in the EPA group vs 127 [ 1.7 % ] in the control group ; p=0.132 ) . INTERPRETATION EPA is a promising treatment for prevention of major coronary events , and especially non-fatal coronary events , in Japanese hypercholesterolaemic patients Bococizumab is a humanized monoclonal antibody binding proprotein convertase subtilisin/kexin type 9 , which may be a potential therapeutic option for reducing low-density lipoprotein cholesterol ( LDL-C ) levels in patients with hypercholesterolemia . In this 24-week , multicenter , double-blind , placebo-controlled , dose-ranging study ( NCT01592240 ) , subjects with LDL-C levels≥80 mg/dl on stable statin therapy were r and omized to Q14 days subcutaneous placebo or bococizumab 50 , 100 , or 150 mg or Q28 days subcutaneous placebo or bococizumab 200 or 300 mg . Doses of bococizumab were reduced if LDL-C levels persistently decreased to ≤25 mg/dl . The primary end point was the absolute change in LDL-C levels from baseline to week 12 after placebo or bococizumab administration . Continuation of bococizumab administration through to week 24 enabled the collection of safety data over an extended period . Of the 354 subjects r and omized , 351 received treatment ( placebo [ n=100 ] or bococizumab [ n=251 ] ) . The most efficacious bococizumab doses were 150 mg Q14 days and 300 mg Q28 days . Compared with placebo , bococizumab 150 mg Q14 days reduced LDL-C at week 12 by 53.4 mg/dl and bococizumab 300 mg Q28 days reduced LDL-C by 44.9 mg/dl ; this was despite dose reductions in 32.5 % and 34.2 % of subjects at week 10 or 8 , respectively . Pharmacokinetic/pharmacodynamic model-based simulation assuming no dose reductions predicted that bococizumab would lower LDL-C levels by 72.2 and 55.4 mg/dl , respectively . Adverse events were similar across placebo and bococizumab groups . Few subjects ( n=7 ; 2 % ) discontinued treatment because of treatment-related adverse events . In conclusion , bococizumab significantly reduced LDL-C across all doses despite dose reductions in many subjects . Model-based simulations predicted greater LDL-C reduction in the absence of bococizumab dose reduction . The Q14 days regimen is being evaluated in phase 3 clinical trials A total of 96 patients with moderate elevations of low-density lipoprotein ( LDL ) cholesterol were r and omly assigned to 4 different double-blind treatment regimens : placebo ; colestipol 5 g and lovastatin 20 mg/day ( C5 + L20 ) ; colestipol 10 g and lovastatin 20 mg/day ( C10 + L20 ) ; and lovastatin 40 mg/day ( L40 ) . During 12 weeks of therapy , C10 + L20 achieved the greatest reduction in total cholesterol ( -32 % ) and LDL cholesterol ( -48 % ) levels from baseline . This combination also exhibited significantly greater reductions in LDL cholesterol levels than the C5 + L20 and L40 groups ( p < 0.01 ) . The differences in total and LDL cholesterol reduction between the C5 + L20 and L40 groups were not significant . Similar changes and differences between treatments were seen in apolipoprotein B levels . Whereas mean total apolipoprotein A-I levels increased with all treatments ( p < 0.05 ) , lipoprotein particles A-I were significantly increased in the C10 + L20 group ( p < 0.01 ) only . Results demonstrate that the combination of low-dose lovastatin ( 20 mg/day ) with low-dose colestipol ( 5 or 10 g/day ) produces LDL cholesterol reductions equal to or greater than higher doses of lovastatin ( 40 mg/day ) . In addition , low-dose combinations are > 25 % more cost-effective than high-dose monotherapy In a double-blind clinical trial of clofibrate versus identical quantity of corn oil 497 patients with ischaemic heart disease were observed over a period of five years . The death rate and the rate of non-fatal infa rcts were significantly less among the clofibrate group , and the difference was greatest in respect of sudden deaths and among
Output:
| FINDINGS Niacin may reduce cardiovascular events as monotherapy ; however , recent trials in combination with statins have failed to show a benefit .
Trials with omega-3 FAs have failed to demonstrate significant reductions in cardiovascular outcomes .
Fibrates may improve cardiovascular outcomes as monotherapy ; however , trials in combination with statins have failed to show a benefit , except in those with elevated triglycerides ( > 200 mg/dL ) or low HDL-C ( < 40 mg/dL ) .
There is a lack of data that evaluates bile acid sequestrant in combination with statin therapy on reducing cardiovascular events .
IMPLICATION S Nonstatin therapies have a limited role in reducing cardiovascular events in those maintained on guideline -directed statin therapy .
In certain clinical situations , such as patients who are unable to tolerate statin therapy or recommended intensities of statin therapy , those with persistent severe elevations in triglycerides , or patients with high cardiovascular risk , some nonstatin therapies may be useful in reducing cardiovascular events . |
MS213486 | ***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 few published direct comparative studies of the tolerability and efficacy of atypical antipsychotic agents were performed in relatively homogeneous population s that may not be typical of patients seen in clinical practice . OBJECTIVE The Quetiapine Experience with Safety and Tolerability ( QUEST ) study compared the relative safety , tolerability , and efficacy of quetiapine and risperidone in out patients with a broad range of psychotic symptoms . METHODS This was a multicenter , 4-month , open-label , r and omized clinical trial . Patients were r and omized in a 3:1 ratio to receive quetiapine or risperidone . Doses were adjusted to maximize efficacy and to minimize adverse events . Extrapyramidal symptoms ( EPS ) were assessed with an EPS checklist ; adverse events were recorded . Efficacy was assessed using the Clinical Global Impression ( CGI ) scale , Positive and Negative Symptom Scale ( PANSS ) , and Hamilton Rating Scale for Depression ( HAM-D ) . RESULTS A total of 728 patients were r and omized , 553 to quetiapine and 175 to risperidone . Mean prescribed doses over the study period were 253.9 mg/d quetiapine and 4.4 mg/d risperidone . At the end of 4 months , EPS declined in both treatment groups , but quetiapine-treated patients were significantly less likely to require dose adjustment or concurrent anti-EPS medication ( P < 0.001 ) . The most common adverse events in the quetiapine and risperidone groups were somnolence ( 31.3 % and 15.4 % , respectively ) , dry mouth ( 14.5 % and 6.9 % ) , and dizziness ( 12.7 % and 6.9 % ) . Overall , tolerance to side effects with the 2 drugs , measured by dropout rates , was comparable . At each visit , a higher percentage of quetiapine-treated patients showed improvement on the CGI scale , but there were no significant between-group differences on the PANSS . At end point , quetiapine-treated patients had significantly lower HAM-D scores ( P = 0.028 ) . CONCLUSIONS The results of this study suggest that quetiapine is as effective as risperidone for the treatment of psychotic symptoms , is more effective for depressive symptoms , may have a more favorable EPS profile , and has comparable overall tolerability BACKGROUND Quetiapine ( ICI 204,636 , ' Seroquel ' ) is a new atypical antipsychotic agent with a similar binding profile to the original atypical antipsychotic , clozapine . Its clinical efficacy has already been demonstrated at multiple fixed doses ( 150 - 750 mg/day ) and has been suggested to be comparable with haloperidol ( 12 mg/day ) . METHODS This international , 6-week , multicentre , double-blind , r and omized , parallel-group trial compared quetiapine with haloperidol ( 455 mg and 8 mg mean total daily doses , respectively ) in 448 hospitalized patients with acute exacerbation of chronic or subchronic schizophrenia ( DSM-III-R ) , in order to establish their equivalence in terms of efficacy , and the nature of their tolerability profiles , especially in terms of extrapyramidal symptoms ( EPS ) and serum prolactin levels . RESULTS Both quetiapine and haloperidol produced a clear reduction in the Positive and Negative Syndrome Scale ( PANSS ) scores and Clinical Global Impression ( CGI ) Severity of Illness and Global Improvement scores . At day 42 , the PANSS total score was reduced by -18.7+/-1.63 in the quetiapine group , and -22.1+/-1.63 in the haloperidol group ( P = 0.13 , between-treatment ) . Quetiapine was better tolerated than haloperidol in terms of EPS as demonstrated by the significant differences in the Simpson Scale and Abnormal Involuntary Movement Scale scores ( P < 0.05 ) . Although patients in both groups had elevated serum prolactin concentrations at baseline , mean serum prolactin concentration decreased ( by 16.5 microg/l ) in quetiapine-treated patients , yet increased ( by 5.9 microg/l ) in patients treated with haloperidol . CONCLUSION Quetiapine is an effective and well tolerated antipsychotic of comparable efficacy to haloperidol and lacks the latter compound 's effect on prolactin and EPS Treating schizophrenia is expensive . Preventing rehospitalization of patients with schizophrenia provides an attractive opportunity for cost savings , especially for patients with ' revolving-door ' or multiple-episode schizophrenia . Reducing the occurrence of extrapyramidal symptoms and other adverse events associated with st and ard antipsychotic agents may increase compliance and reduce the rate of rehospitalization of patients with schizophrenia . Quetiapine ( ' Seroquel ' , ICI 204,636 , Zeneca Pharmaceuticals ) is a new dibenzothiazepine antipsychotic agent with a low propensity for extrapyramidal symptoms . We describe here a unique methodology to compare quetiapine with usual-care medications in real-world treatment setting s. The trial objective is to determine if therapy with this new atypical antipsychotic agent can reduce the rate of rehospitalization and , therefore , treatment costs . Using two secondary medical-cl aims data bases , we defined the minimal threshold for revolving-door status as 1.0 admission per year ; this definition allows our trial to focus on the sub population of schizophrenic patients with the greatest potential for cost savings by either the new atypical antipsychotic quetiapine or usual-care therapy . We describe here the approach used in our trial Abstract We investigated the striatal dopamine-2 ( D2 ) receptor occupancy caused by different antipsychotic substances in 18 psychotic patients ( 16 with schizophrenic and two with schizoaffective disorder according to DSM-IV ) with single photon emission computed tomography ( SPECT ) using 123I-iodobenzamide ( IBZM ) as tracer substance . Four patients were treated with the novel antipsychotic compound quetiapine ( 300–700 mg/day ) , six with clozapine ( 300–600 mg/ day ) and eight with haloperidol ( 10–20 mg/day ) . They were compared with eight healthy controls . Measurement of S/F ratios and consecutive calculation of D2 receptor occupancy revealed a significantly lower striatal D2 occupancy rate with quetiapine and clozapine in comparison to haloperidol . In correspondence with the low striatal D2 receptor occupancy rates and again in contrast to the haloperidol treatment group , there were no extrapyramidal motor side-effects ( EPS ) in the quetiapine and clozapine treatment groups . Therefore , the reported data support the position that quetiapine can be considered to be an atypical antipsychotic substance due to its relatively weak striatal D2 receptor blocking property and therefore its low propensity to induce EPS Abstract Quetiapine ( Seroquel , ICI 204,636 ) is an atypical antipsychotic that is effective in the treatment of both positive and negative symptoms of schizophrenia , and has a low propensity to cause extrapyramidal symptoms . The compound has a relatively short plasma elimination half-life ( approximately 7 h ) . However , since dopamine D2 receptor occupancies correlate poorly with plasma concentrations of antipsychotics , plasma elimination half-life may not predict either duration of clinical effect or dosing frequency . Accordingly , the efficacy and tolerability of three dosing regimens ( 450 mg/day given in two or three divided doses daily , and 50 mg/day given twice daily ) were compared in a 6-week , double-blind , r and omized , multicentre , parallel-group study . The study recruited hospitalized men and women aged 18–65 years meeting DSM-IIIR criteria for acute exacerbation of chronic or subchronic schizophrenia . Six hundred and eighteen patients were r and omly assigned to treatment with quetiapine 150 mg tid ( n = 209 ) , 225 mg bd ( n = 200 ) , or a comparator dose of 25 mg bd ( n = 209 ) . At day 42 , the last day of r and omized treatment and the primary timepoint for efficacy , quetiapine 450 mg/day was more effective than 50 mg/day : 225 mg bd was consistently superior to 25 mg bd in all measures of efficacy ( total BPRS , P = 0.006 ; CGI severity , CGI improvement and SANS , P < 0.03 ) , and 150 mg tid was statistically significantly superior to 25 mg bd with respect to BPRS total score ( P = 0.05 ) . The 225 mg bd and 150 mg tid groups were not significantly different from each other with respect to any efficacy measure . Quetiapine was generally well tolerated . Extrapyramidal symptom ( EPS ) adverse events were generally rare , and occurred with similar frequencies in the two 450 mg/day groups . Quetiapine was not associated with sustained increases in plasma prolactin at any dose . These data support the atypical profile developed from pre clinical studies and show that quetiapine is an effective , well tolerated antipsychotic that can be given twice daily OBJECTIVE To assess the efficacy of quetiapine , a recently introduced second generation antipsychotic medication , in reducing cognitive impairment in patients with schizophrenia . DESIGN Prospect i ve , r and omized , double-blind clinical trial . PATIENTS 25 patients who met the Diagnostic and Statistical Manual of Mental Disorders , fourth edition , ( DSM-IV ) criteria for schizophrenia were recruited from 3 Canadian hospitals . INTERVENTION AND OUTCOME MEASURES After a 48-hour washout period , 25 patients with schizophrenia were r and omly assigned to double-blind treatment with quetiapine or haloperidol for 6 months and evaluated with rating scales for psychotic symptoms , mood and extrapyramidal side effects , as well as st and ardized neuropsychological measures sensitive to 6 cognitive domains : fine motor skill , attention span , verbal reasoning and fluency , visuospatial construction and fluency , executive skills and visuomotor tracking , and immediate recall of verbal and nonverbal material s. The measures were repeated 8 weeks and 6 months after treatment was initiated . RESULTS Quetiapine improved psychosis and mood without inducing extrapyramidal symptoms . Quetiapine also had beneficial effects on cognitive skills , particularly verbal reasoning and fluency skills and immediate recall , with additional improvements on executive skills and visuomotor tracking and on the average of the 6 cognitive domains with sustained treatment . Patients taking haloperidol showed improvements in general clinical status , but no specific improvements on the positive syndrome , the negative syndrome , depression ratings or cognitive skills . CONCLUSIONS These preliminary results support the potential value of quetiapine for improving cognitive impairment in patients with schizophrenia and emphasize the importance of further research with this promising atypical antipsychotic In a double-blind study , 135 in patients with a diagnosis of chronic schizophrenia were r and omly assigned to 8 weeks of treatment with one of six parallel treatments : risperidone ( a new central 5-hydroxytryptamine2 and dopamine D2 antagonist ) , 2 , 6 , 10 , 16 mg/day ; haloperidol , 20 mg/day ; or placebo , after a single-blind placebo washout period . Doses were increased in fixed increments up to a fixed maintenance dose reached after 1 week . On the Clinical Global Impression-Severity of Illness and Improvement , all active medications were superior to placebo except for risperidone ( 2 mg ) on the Clinical Global Impression-Improvement . On the total Positive and Negative Syndrome Scale ( PANSS ) score and positive subscale , superiority to placebo was observed for all treatment groups except for haloperidol and risperidone ( 2 mg ) , which tended to be superior to placebo on total PANSS and the positive subscale , respectively . On the PANSS negative subscale , only risperidone ( 6 mg/day ) was significantly better than placebo . Risperidone ( 6 mg ) was superior to haloperidol on the total PANSS , General Psychopathology , and Brief Psychiatric Rating Scale subscales . Although there was a linear increase in parkinsonism with increasing risperidone dosage , there were no statistically significant differences between risperidone ( 2 , 6 , and 16 mg/day ) and placebo . At doses of 6 to 16 mg , risperidone displayed a marked antidyskinetic effect compared with placebo . This effect was more pronounced in patients with severe dyskinesia . By contrast , haloperidol produced significantly more parkinsonism than placebo and risperidone ( 2 , 6 and 16 mg ) , with no effect on tardive dyskinesia . These data suggest that risperidone , at the optimal therapeutic dose of 6 mg/day , produced significant improvement in both positive and negative symptoms without an increase in drug-induced parkinsonian symptoms and with a significant beneficial effect on tardive dyskinesia The treatment of schizophrenic patients who fail to respond to adequate trials of neuroleptics is a major challenge . Clo
Output:
| Data incorporating considerable assumptions about the many people who left early suggest that global state and psychotic symptoms - both positive and negative - may be more helped by quetiapine than placebo .
While the incidences of extrapyramidal side effects are not different between quetiapine and placebo , side effects such as dizziness and dry mouth are more prevalent in the quetiapine treated group .
Quetiapine is as potent as chlorpromazine and haloperidol as regards global and mental state but it may cause higher incidences of dry mouth and sleepiness .
Extrapyramidal side effects are the same as those of chlorpromazine but may be less than haloperidol .
There are no clear differences between high and low dose groups in respect of extrapyramidal side effects . |
MS213487 | ***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: Abstract Objectives To prospect ively compare the diagnostic performance of ultrasound ( US ) , multidetector computed tomography ( MDCT ) and contrast-enhanced magnetic resonance imaging ( MRI ) in cirrhotic patients who were c and i date s for liver transplantation . Methods One hundred and forty consecutive patients with 163 hepatocellular carcinoma ( HCC ) nodules underwent US , MRI and MDCT . Diagnosis of HCC was based on pathological findings or substantial growth at 12-month follow-up . Four different image data sets were evaluated : US , MDCT , MRI unenhanced and dynamic phases , MRI unenhanced dynamic and hepatobiliary phase . Diagnostic accuracy , sensitivity , specificity , PPV and NPV , with corresponding 95 % confidence intervals , were determined . Statistical analysis was performed for all lesions and for three lesion subgroups ( < 1 cm , 1 - 2 cm , > 2 cm ) . Results Significantly higher diagnostic accuracy , sensitivity and NPV was achieved on dynamic + hepatobiliary phase MRI compared with US , MDCT and dynamic phase MRI alone . The specificity and PPV of US was significantly lower than that of MDCT , dynamic phase MRI and dynamic + hepatobiliary phase MRI . Similar results were obtained for all sub-group analyses , with particular benefit for the diagnosis of smaller lesions between 1 and 2 cm . Conclusions Dynamic + hepatobiliary phase MRI improved detection and characterisation of HCC in cirrhotic patients . The greatest benefit is for diagnosing lesions between 1 and 2 cm . Key Points• US , CT and MRI can all identify HCC in cirrhotic patients • US has good sensitivity but suffers from false-positive findings • Dynamic CT and MR have similar diagnostic performance for diagnosing HCC • Dynamic + hepatobiliary phase MRI significantly improves detection and characterisation of HCC • The greatest benefit is for the diagnosis of lesions between 1 and 2 PURPOSE To compare two different injection rates for gadoxetic acid-enhanced hepatic arterial phase images on hepatic dynamic MRI . MATERIAL S AND METHODS Hepatic arterial phase images were obtained after an intravenous bolus injection of gadoxetic acid at a rate of 1 mL/second in 62 patients and 2 mL/second in 64 patients on a 3 Tesla MR scanner using a test-bolus injection method . The signal-to-noise ratios ( SNR ) of the liver , portal vein , hepatic vein , aorta , spleen and pancreas were measured . The contrast-to-noise ratio ( CNR ) of hypervascular hepatic tumors was calculated . Two radiologists independently scored items to evaluate image quality of hepatic arterial phase and detected hypervascular hepatocellular carcinoma ( HCC ) . RESULTS The SNR of the aorta on the arterial phase images was significantly higher in the 1 mL/second group ( 235.43 + /- 82.59 ) than in the 2 mL/second group ( 190.94 + /- 96.90 , P < 0.05 ) . The SNRs of the liver , spleen and pancreas , the CNRs of hypervascular hepatic tumors , the detection rate of hypervascular HCC and subjective ratings for the optimal arterial enhancement were comparable between the two groups . CONCLUSION Injection rates of 2 mL/second and 1 mL/second provided comparable image qualities on arterial phase images of hepatic dynamic MRI using gadoxetic acid BACKGROUND & AIMS To prospect ively assess the diagnostic accuracy of the incorporation of additional magnetic resonance imaging ( MRI ) parameters in those based on contrast enhancement pattern for the diagnosis of solitary nodules between 5 and 20 mm , detected during surveillance in patients with cirrhosis . METHODS Between November 2003 and January 2010 , we prospect ively included 159 cirrhotic patients with a newly detected solitary nodule between 5 and 20 mm in diameter by screening ultrasonography ( US ) . Hepatic MRI and fine-needle biopsy were performed in all patients . RESULTS Final diagnoses were hepatocellular carcinoma ( HCC ) ( n=103 ) , other malignant lesions ( intrahepatic cholangiocarcinoma/metastases ) ( n=4 ) , and benign lesions ( n=52 ) . The specific enhancement pattern ( arterial enhancement followed by washout ) yielded a sensitivity and specificity of 58.3 % and 96.4 % , respectively . Peritumoral capsule was present in 43 HCC and in 2 non-HCC lesions . Intralesional fat was detected in 24 nodules ; 5 nodules were non-HCC . Finally , the presence of both capsule and fat was observed in 10 cases , all of them HCC ( 100 % specificity ) , but all of them also displayed the specific enhancement pattern , thus adding no sensitivity or specificity . CONCLUSIONS Conclusive non-invasive diagnosis of HCC in cirrhosis should be based only on the contrast enhancement pattern , while other characteristics at MRI do not increase the diagnostic accuracy PURPOSE To prospect ively compare gadoxetate disodium-enhanced magnetic resonance ( MR ) imaging with multiphasic 64-section multidetector computed tomography ( CT ) in the detection of hepatocellular carcinoma ( HCC ) in patients with cirrhosis . MATERIAL S AND METHODS Institutional review board approval and informed patient consent were obtained for this prospect i ve study . Fifty-eight patients ( 39 men , 19 women ; mean age , 63 years ; age range , 35 - 84 years ) underwent gadoxetate disodium-enhanced MR imaging and multiphasic 64-section multidetector CT . The imaging examinations were performed within 30 days of each other . The two sets of images were qualitatively analyzed in r and om order by three independent readers in a blinded and retrospective fashion . Using strict diagnostic criteria for HCC , readers classified all detected lesions with use of a four-point confidence scale . The reference st and ard was a combination of pathologic proof , conclusive imaging findings , and substantial tumor growth at follow-up CT or MR imaging ( range of follow-up , 90 - 370 days ) . The diagnostic accuracy , sensitivity , and positive predictive value were compared between the two image sets . Interreader variability was assessed . The accuracy of each imaging method was determined by using an adjusted modified chi(2 ) test . RESULTS Eighty-seven HCCs ( mean size + /- st and ard deviation , 1.8 cm + /- 1.5 ; range , 0.3 - 7.0 cm ) were confirmed in 42 of the 58 patients . Regardless of lesion size , the average diagnostic accuracy and sensitivity for all readers were significantly greater with gadoxetate disodium-enhanced MR imaging ( average diagnostic accuracy : 0.88 , 95 % confidence interval [ CI ] : 0.80 , 0.97 ; average sensitivity : 0.85 , 95 % CI : 0.74 , 0.96 ) than with multidetector CT ( average diagnostic accuracy : 0.74 , 95 % CI : 0.65 , 0.82 ; average sensitivity : 0.69 , 95 % CI : 0.59 , 0.79 ) ( P < .001 for each ) . No significant difference in positive predictive value was observed between the two image sets for each reader . Interreader agreement was good to excellent . CONCLUSION Compared with multiphasic 64-section multidetector CT , gadoxetate disodium-enhanced MR imaging yields significantly higher diagnostic accuracy and sensitivity in the detection of HCC in patients with cirrhosis BACKGROUND & AIMS To determine the optimal imaging scan or combinations in terms of diagnostic performance and re source utilization for 1 - 2 cm nodules found on surveillance for hepatocellular carcinoma . METHODS Eighty-four cirrhotic patients with 101 , 1 - 2 cm nodules ( 34 malignant , 67 non-malignant ) prospect ively underwent st and ardized contrast-enhanced ultrasound , CT , and MRI scans . Sensitivity/specificity and potential imaging/biopsy utilization of individual imaging modalities and two-modality combinations performed at the same time ( coincidental ) or in sequence were measured . Final diagnosis was determined by biopsy ( 23 ) , growth ( 10 ) , recurrence ( 1 ) , or stability in size for ≥ 18 months ( 67 ) . RESULTS For single imaging scans , sensitivities/specificities ranged between 53 - 62 % and 91 - 100 % . When two scans were combined requiring both to be positive , sensitivities/specificities ranged between 29 - 41 % and 99 - 100 % . When two scans were combined sequentially , requiring only one to be positive , sensitivities/specificities ranged between 74 - 89 % and 91 - 99 % . When comparing combination of two positive tests ( MRI and CT ) to MRI alone , there was a significant drop in sensitivity ( 41 % vs. 62 % , p=0.02 ) , no change in specificity ( both 100 % ) , with twice as many scans performed , and 9 % rise in potential biopsies or 7 % rise in follow-up scans . When comparing the combination of MRI then CT ( if MRI negative ) to MRI alone , there was an insignificant rise in sensitivity ( 74 % vs. 62 % , p=0.13 ) , drop in specificity ( 97 % vs. 100 % ) , with 77 % more scans performed , and 6 % drop in potential biopsies or 7 % drop in potential follow-up scans . CONCLUSIONS Single imaging scans have similar specificity to two coincidental positive scans with much less re source utilization . Sequential imaging provides the best sensitivity but with diminished specificity Objective To prospect ively assess the additional value of the hepatobiliary ( HB ) phase of Gd-EOB-DTPA-MRI in identifying and characterising small ( ≤2 cm ) hepatocellular carcinomas ( HCCs ) undetermined in dynamic phases alone because of their atypical features , according to the AASLD criteria . Methods 127 cirrhotic patients were evaluated with Gd-EOB-DTPA-MRI in two sets : unenhanced and dynamic phases ; unenhanced , dynamic and HB phases . Sixty-two out of 215 nodules ( 29 % ) were atypical in 42 patients ( 33 % ) . Results 62 atypical nodules were reported at histology : high- grade dysplastic nodules (HGDN)/early HCC ( n = 20 ) , low- grade DN ( LGDN ) ( n = 21 ) , regenerative nodules ( n = 17 ) and nodular regenerative hyperplasia ( n = 4 ) . The sensitivity , specificity , accuracy , positive and negative predictive value ( PPV , NPV ) were increased by the addition of the HB phase : 88.4–99.4 % , 88–95 % , 88–98.5 % , 97–99 % , and 65–97.5 % , respectively . Twenty atypical nodules were malignant ( 32 % ) , 19 of which were characterised only during the HB phase . Conclusions The HB phase is 11 % more sensitive in the classification of HGDN/early HCC than dynamic MRI , with an added value of 32.5 % in the NPV . The high incidence ( 33 % ) of atypical nodules and their frequent malignancy ( 32 % ) suggest the widespread employment of Gd-EOB-DTPA-MRI in the follow-up of small nodules ( ≤2 cm ) in cirrhosis In a prospect i ve study , we examined the impact of arterial hypervascularity , as established by the European Association for the Study of the Liver ( EASL ) recommendations , as a criterion for characterizing small ( 1‐3 cm ) nodules in cirrhosis . A total of 72 nodules ( 1‐2 cm , n = 41 ; 2.1‐3 cm , n = 31 ) detected by ultrasonography in 59 patients with cirrhosis were included in the study . When coincidental arterial hypervascularity was detected at contrast perfusional ultrasonography and helical computed tomography , the lesion was considered to be hepatocellular carcinoma ( HCC ) according to EASL criteria . When one or both techniques showed negative results , ultrasound‐guided biopsy was performed . In cases with negative results for malignancy or high‐ grade dysplasia , biopsy was repeated when an increase in size was detected at the 3‐month follow‐up examination . Coincidental hypervascularity was found in 44 of 72 nodules ( 61 % ; 44 % of 1‐2‐cm nodules and 84 % of 2‐3‐cm nodules ) . Fourteen nodules ( 19.4 % ) had negative results with both techniques ( hypovascular nodules ) . Biopsy showed HCC in 5 hypovascular nodules and in 11 of 14 nodules with hypervascularity using only one technique . All nodules larger than 2 cm finally result ed to be HCC . Not satisfying the EASL imaging criteria for diagnosis were 38 % of HCCs 1 to 2 cm ( 17 % hypovascular ) and 16 % of those 2 to 3 cm ( none hypovascular ) . In conclusion , the noninvasive EASL criteria for diagnosis of HCC are satisfied in only 61 % of
Output:
| In conclusion , Gd-EOB-DTPA-enhanced MRI demonstrated higher sensitivity and overall diagnostic accuracy than MDCT , and thus should be the preferred imaging modality for diagnosing small HCCs measuring up to 2 cm . |
MS213488 | ***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 Firstly , to compare the findings of interictal 18F-fluorodeoxyglucose ( FDG ) positron emission tomography ( PET ) and of single photon emission computed tomography ( SPECT ) using 99mTc-hexamethyl propylene-amine-oxime ( HMPAO ) and 123I-iomazenil in localising the epileptogenic cortex in patients who were c and i date s for epilepsy surgery , but in whom clinical findings , video EEG monitoring ( V-EEG ) , MRI , and neuropsychological evaluations did not give any definite localisation of the seizure onset . Secondly , to assess the ability of these functional methods to help in the decision about the epilepsy surgery . METHODS Eighteen epileptic patients were studied with FDG-PET and iomazenil-SPECT . HMPAO-SPECT was performed in 11 of these 18 patients . Two references for localisation was used — ictal subdural EEG recordings ( S-EEG ) and the operated region . RESULTS Fifteen of 18 patients had localising findings in S-EEG . FDG-PET findings were in accordance with the references in 13 patients and iomazenil-SPECT in nine patients . HMPAO-SPECT visualised the focus less accurately than the two other methods . In three patients S-EEG showed independent bitemporal seizure onset . In these patients FDG-PET showed no lateralisation . However , iomazenil-SPECT showed temporal lobe lateralisation in two of them . CONCLUSION FDG-PET seemed to localise the epileptogenic cortex more accurately than interictal iomazenil-SPECT in patients with complicated focal epilepsy Despite advances in morphological imaging , some patients with lung cancer are found to have nonresectable disease at surgery or die of recurrence within yr of surgery . We performed a prospect i ve study in 109 patients to compare the accuracy of whole-body positron emission tomography ( PET ) using fluorine-18 deoxyglucose ( 18FDG ) and conventional imaging ( CI ) methods for the staging of non-small cell lung cancer ( NSCLC ) . When CI or PET study suggested metastatic disease , confirmation was obtained by biopsy or follow-up information . As compared to CI , 18FDG-PET correctly changed the N stage in 22 patients ( 33 % ) and the M stage in 15 patients ( 14 % ) . For the detection of distant metastases , PET study showed five false-positive sites and no false-negative cases . Currently , the accuracy of PET in the detection of M stage is 96 % . Our study shows that visual interpretation of whole-body fluorine-18 deoxyglucose-positron emission tomography images can improve the diagnostic accuracy in the staging of non-small cell lung cancer . Further experience is needed to establish if metabolic imaging would be a cost-effective tool in the future management of lung cancer The main aim of the study was to evaluate the use of positron emission tomography using fluoro-deoxyglucose ( PET-FDG ) imaging for the detection of squamous cell carcinoma of the head and neck . Fifty-four consecutive patients with malignancies involving the head and neck were studied prospect ively . Thirty-one patients presented with primary disease and 23 were suspected of recurrent or residual disease . All patients underwent full clinical staging , PET-FDG scans and anatomical imaging , 37 underwent computed tomography ( CT ) , 13 magnetic resonance ( MR ) and four had both CT and MR . Clinical assessment , CT/MR , PET-FDG and histological examination were all evaluated independently of each other . All 31 primary head and neck malignant tumours were detected by PET-FDG . Based on 16 patients who underwent neck dissections , the sensitivity and specificity of PET-FDG for detecting nodal disease was 67 % and 100 % respectively , compared with clinical assessment of 58 % and 75 % and CT/MR of 67 % and 25 % . In all 12 patients , PET-FDG correctly identified the presence of absence or recurrent or residual disease . PET-FDG staged 13 post-treatment necks with an accuracy of 100 % as compared to CT/MR which was accurate in 7 of 13 and clinical assessment which was accurate in eight . Three sites of abnormal tracer uptake unrelated to malignancy were recorded as incidental findings ( m and ibular osteomyelitis , 1 : post glossectomy site , 2 ) . PET-FDG was more accurate than CT/MR for identifying primary and recurrent tumours as well as metastatic lesions in the neck . If these diagnostic properties of PET-FDG are confirmed in further prospect i ve studies , it could prove a valuable adjunct for the management of head and neck cancer During an 18 month period 39 patients were evaluated with [ 18F ] fluorodeoxyglucose-PET ( FDG-PET ) for primary brain tumours . These included patients with suspected newly diagnosed tumours and patients with known tumours who were being evaluated for possible recurrence or increasing tumour grade . Scans were performed on a 951 - 31 Siemen 's PET scanner with 4 mm resolution . Scanning time was about 20 minutes per patient . All patients had undergone recent cerebral MRI . These patients were divided into two groups . In the first group ( 30 ) MRI and PET concurred on the diagnosis . The second group ( nine ) comprised those where the interpretation of MRI and PET was different or there was a question of the diagnosis on MRI . This group comprised three patients in whom MRI suggested recurrent tumour and PET inaccurately suggested radiation necrosis ; two patients with newly diagnosed enhancing lesions on MRI in whom PET was useful in distinguishing strokes from tumour ; two patients with prior gliomas with new enhancing isolated lesions on MRI in whom PET scan accurately depicted radiation necrosis ; and two patients with newly diagnosed enhancing lesions on MRI in whom PET scan was helpful in distinguishing multiple sclerosis from tumour in one but not in the other . Therefore , of the 39 patients , PET was helpful in five in distinguishing tumour from other disease processes ; but , in so far as influencing treatment , it seemed helpful in only two . Thus PET seems to be of limited value as an aid to evaluating and treating patients with suspected or known primary brain tumours UNLABELLED The aim of this prospect i ve study was to investigate if high uptake of 18F-fluoro-2-deoxy-D-glucose ( FDG ) is associated with aggressiveness in head and neck cancer and low probability of survival . METHODS Thirty-seven patients with squamous-cell carcinoma of the head and neck underwent FDG-PET in the fasting state before cancer treatment . FDG uptake in primary tumor was quantitated as the st and ardized uptake value of FDG normalized to the predicted lean body mass ( SUVlean , n = 37 ) and as the graphically determined metabolic rate for FDG ( rMR[FDG ] , n = 34 ) . Paraffin-embedded tumor sample s were used for histologic evaluation , and expression of cytokeratin and Ki-67 antigen were assessed by immunohistochemistry . RESULTS Interobserver agreement for the determination of quantitative uptake of FDG in tumors was excellent ( r2 = 0.996 , p < 0.00001 ) , and all 37 primary tumors were visualized . A high uptake of FDG as assessed by SUVlean was associated with a higher than the median mitotic count ( p = 0.01 ) , absence of keratinization ( p = 0.03 ) , low or moderate histological grade of differentiation ( p = 0.046 ) and advanced stage ( p = 0.03 ) , but not with Ki-67 expression ( p = 0.11 ) . The overall survival of patients with a SUVlean lower than or equal to the median value ( 9.0 ) was clearly better in univariate analysis than that of patients with a SUVlean higher than the median ( 3-yr survival 73 % versus 22 % , relative risk of death ( RR ) 4.2 , 1.6 - 11.0 ) . However , in a multivariate analysis the only independent predictors of survival were the mitotic count ( RR 4.0 , 1.4 - 11.7 ) and stage ( 3.8 , 1.2 - 12.2 ) . CONCLUSION High uptake of FDG in untreated head and neck cancer is associated with advanced disease , and may portend poor survival . Aggressive treatment approaches should be considered for patients presenting with a tumor with high uptake of FDG UNLABELLED This study evaluated various quantitative criteria for analysis of breast imaging with PET using the radiolabeled glucose analog 18F-fluorodeoxyglucose ( FDG ) . METHODS In a prospect i ve study , 73 patients with abnormal mammography or palpable breast masses scheduled for biopsy were investigated with PET . A total of 97 breast tumors were evaluated by histology , including 46 benign and 51 malignant tumors . Using a whole-body PET scanner , attenuation-corrected images were acquired between 40 and 60 min after tracer injection . For Patlak analysis , dynamic data acquisition was obtained in 24 patients . To differentiate between benign and malignant breast tumors , receiver operating characteristic curves were calculated using incrementally increasing threshold values for tumor/ nontumor ratios based on average and maximum activity values per region of interest , st and ardized uptake values ( corrected for partial volume effect , normalized to blood glucose , partial volume effect and blood glucose , using the lean body mass as well as the body surface area ) and calculating the FDG influx rate ( K ) assessed by Patlak analysis . RESULTS Quantification of FDG uptake in breast tumors provided objective criteria for differentiation between benign and malignant tissue with similar diagnostic accuracy as compared with visual analysis . Applying correction for partial volume effect and normalization by blood glucose yielded the highest diagnostic accuracy . CONCLUSIONS These quantitative methods provided accurate evaluation of PET data for differentiating benign from malignant breast tumors . Quantitative assessment is recommended to complement visual image interpretation with the potential benefit of reduced interobserver variability Recent studies have shown limitations of morphological imaging in staging mediastinal lymph node involvement in lung cancer . In contrast to computed tomography ( CT ) , which depends primarily on anatomical imaging features , positron emission tomography ( PET ) with 18-fluorodeoxyglucose ( FDG ) depends mainly on the metabolic characteristics of a tissue for the diagnosis of disease . We have performed a prospect i ve study comparing FDG-PET and CT of the thorax in the presurgical assessment of the mediastinum in 50 patients with newly diagnosed non-small cell lung cancer ( NSCLC ) . CT and PET scans were interpreted separately , and results were compared to pathological staging obtained during thoracotomy . Hilar or mediastinal lymph node involvement was present in 58 % . In staging for lymph node involvement , CT had a sensitivity of 72 % and specificity of 81 % , whereas PET had a sensitivity and specificity of 90 % and 86 % , respectively . When the PET study was compared to histological results , there were four cases showing more advanced mediastinal involvement with PET and four cases showing less involvement with PET . From our preliminary results , we conclude that positron emission tomography with 18-fluorodeoxyglucose is significantly more accurate than computed tomography in the mediastinal staging of non-small cell lung cancer PURPOSE To prospect ively compare the accuracy of positron emission tomography ( PET ) with 2-[fluorine-18 ] fluoro-2-deoxy-D-glucose ( FDG ) with that of computed tomography ( CT ) in the nodal staging of non-small cell lung cancer . MATERIAL S AND METHODS PET and contrast material -enhanced CT were performed in 47 patients suspected of having or with newly diagnosed non-small cell lung cancer . Each imaging study was evaluated separately , and nodal stations were localized according to the American Thoracic Society mapping system . Extensive lymph node sampling ( 599 nodes from 191 nodal stations ) of the ipsi- and contralateral tracheobronchial and mediastinal nodal stations was performed at thoracotomy and /or mediastinoscopy . Imaging findings were correlated with histopathologic staging results . RESULTS The sensitivity of PET and CT was 89 % and 57 % , respectively , for the staging of N2 or N3 disease in mediastinal nodes ; specificity was 99 % and 94 % , respectively ; positive predictive value was 96 % and 76 % , respectively ; negative predictive value was 97 % and 87 % , respectively ; and accuracy was 96 % and 85 % , respectively . In assigning the correct N stage , PET was correct in 96 % and CT in 79 % of cases . CONCLUSION PET with FDG appears to be superior to CT for nodal staging of non-small cell lung cancer The noninvasive staging of axillary lymph nodes for metastases is investigated in patients with breast cancer prior to surgery by positron emission tomography ( PET ) with fluorine- l8-fluoro-2-deoxy-d-glucose ( 18F-FDG ) . In 124 patients with newly diagnosed breast cancer , whole-body PET was performed to determine the average differential uptake ratio ( DUR ) of18F-FDG in the axillary lymph nodes . Results were correlated with the number of the dissected lymph nodes , size of
Output:
| The results of the Delphi study indicated that the four most important research priorities for the NHS , in descending order of their importance , are : ( 1 ) the relative cost-effectiveness of ( a ) full ring PET , ( b ) gamma camera PET using coincidence imaging and ( c ) existing diagnostic strategies to determine staging prior to operative intervention for lung cancer ; ( 2 ) partial ring PET compared with full ring PET in oncology ( 3 ) the relative cost-effectiveness of ( a ) full ring PET , ( b ) gamma camera PET using coincidence imaging and ( c ) existing diagnostic strategies to stage and monitor treatment response in breast cancer ; ( 4 ) the relative cost-effectiveness of ( a ) gamma camera PET using coincidence imaging and ( b ) 511 keV collimated positron imaging for assessing myocardial viability when selecting patients for revascularisation surgery .
The findings of this project , which was undertaken rapidly in order to inform HTA research prioritization in the UK , provide a contemporary overview of the potential clinical role for PET in the NHS .
Evidence is needed that using PET as a |
MS213489 | ***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: Human subjects were infected with Haemophilus ducreyi . All subjects developed papules and were r and omized to treatment with a single dose of azithromycin ( 1 g ) or ciprofloxacin ( 500 mg ) . At weekly intervals , volunteers were reinoculated with H. ducreyi , and drug concentrations were measured in peripheral blood mononuclear cells ( P BMC ) . When papules developed , the subjects were treated with antibiotics and dismissed from the study . Eight of the ciprofloxacin-treated subjects developed papules 1 week after the initial treatment , and the ninth subject developed disease 2 weeks after treatment . The 9 azithromycin-treated subjects developed papules 4 - 10 weeks ( mean , 6.8 ) after the initial treatment ( P < .001 ) . Azithromycin was detected in P BMC for 3 - 6 weeks ( mean , 4 ) . Pre- and posttreatment lesions had histology typical of experimental chancroid or were culture positive . Azithromycin prevents experimental chancroid for nearly 2 months . These findings have implication s for strategies to prevent chancroid Background and Objectives : Cotrimoxazole has traditionally been used as first drug for treatment of chancroid in India . With reports of increasing resistance to the drug , this study was conducted to compare treatment response of clinical chancroid between ciprofloxacin , 500 mg twice daily for 3 days , erythromycin , 500 mg four times daily for 7 days , and double‐strength cotrimoxazole ( trimethoprim 160 mg + sulfamethoxazole 800 mg ) , twice daily for 7 days . Study Design : Forty‐six patients with a clinical diagnosis of chancroid were r and omly divided into 3 groups . Sixteen patients received ciprofloxacin , whereas 15 each received erythromycin and cotrimoxazole . Patients were seen on day 7 , 14 , and if needed day 21 . Clinical response was noted in terms of cure , improvement , or failure . Results : Excellent response was observed to both ciprofloxacin and erythromycin therapy with cure rates of 93.7 % and 93.3 % , respectively . Improvement was observed in 6.7 % cases in both groups . There were no failures with either ciprofloxacin or erythromycin . Poor response to cotrimoxazole therapy was observed with 53.3 % cure rates and a high failure rate of 46.7 % . Conclusion : Ciprofloxacin and erythromycin are equally effective in chancroid . Ciprofloxacin is better in terms of dosage schedule , duration of treatment , and low cost . Cotrimoxazole should be discontinued as drug of choice because of high failure rates A r and omized , double-blind , placebo-controlled clinical trial was conducted in Nairobi , Kenya , to compare single-dose ciprofloxacin with a 7-day course of erythromycin for the treatment of chancroid . In all , 208 men and 37 women presenting with genital ulcers clinical ly compatible with chancroid were enrolled . Ulcer etiology was determined using culture techniques for chancroid , serology for syphilis , and a multiplex polymerase chain reaction for chancroid , syphilis , and herpes simplex virus ( HSV ) . Ulcer etiology was 31 % unmixed chancroid , 23 % unmixed syphilis , 16 % unmixed HSV , 15 % mixed etiology , and 15 % unknown . For 111 participants with chancroid , cure rates were 92 % with ciprofloxacin and 91 % with erythromycin . For all study participants , the treatment failure rate was 15 % , mostly related to ulcer etiologies of HSV infection or syphilis , and treatment failure was 3 times more frequent in human immunodeficiency virus-infected subjects than in others , mostly owing to HSV infection . Ciprofloxacin is an effective single-dose treatment for chancroid , but current recommendations for empiric therapy of genital ulcers may result in high treatment failure due to HSV infection One hundred and thirty six patients with chancroid were treated with four different treatment regimens ; ( A ) Sulphaphenazole 1 g 12 hourly by mouth x 10 days ( B ) Inj streptomycin 1 g intramuscularly daily with sulphaphenazole 1 g 12 hourly orally x 10 days ; ( C ) trimethoprim 200 mg 12 hourly by mouth x 7 - 10 days , and ( D ) erythromycin 500 mg 6 hourly orally x 7 - 10 days . Cure rates of 9 % with sulphaphenazole alone , 48 % with streptomycin and sulphaphenazole combination , 93 % with trimethoprim and 100 % with erythromycin were obtained . Sulphaphenazole alone or in combination with streptomycin were thus inferior in the treatment of chancroid . There is need for modification of treatment regimens recommended for chancroid in the textbooks of dermatology and venereology . Trimethoprim can be recommended as first line of treatment for chancroid in developing countries like India where resistance to trimethoprim is uncommon and erythromycin is suggested as a second line of therapy because by that time syphilis can be easily ruled out We conducted a r and omized , unblinded , prospect i ve study design ed to determine the efficacy of single-dose azithromycin for the treatment of chancroid . Men and women 16 years of age and older who had darkfield-negative genital ulcers that were clinical ly suspected to be caused by Haemophilus ducreyi and who attended urban sexually transmitted disease clinics or presented to hospital emergency departments were enrolled in the study . Patients were r and omized to receive 250 mg of ceftriaxone i m or 1 g of azithromycin orally , both given as a single dose . They were followed for up to 23 days after treatment . For 65 patients , cultures were positive for H. ducreyi ; there were 68 patients whose cultures were negative for both H. ducreyi and herpes simplex virus and who had no evidence of syphilis . All 133 patients returned for at least one follow-up visit . At the time of the last follow-up visit , all 32 patients whose cultures were positive for H. ducreyi and who were treated with azithromycin were clinical ly cured . In all 33 culture-positive cases in which ceftriaxone was used , there was either clinical improvement or cure at the time of the patient 's last follow-up visit . In addition , azithromycin and ceftriaxone were equally effective in healing ulcers for which cultures were negative . We conclude that a single 1-g oral dose of azithromycin is as effective as a 250-mg i m dose of ceftriaxone for the treatment of chancroid Background and Objectives Chancroid is endemic in sub-Saharan Africa and enhances the sexual transmission of the human immunodeficiency virus Type 1 ( HIV-1 ) . Azithromycin is an orally absorbed macrolide antibiotic that is active against Haemophilus ducreyi , the causative agent of chancroid , and has pharmacokinetic properties that are suitable for single dosing . Study Design In a r and omized single-blinded study of 127 men presenting to a referral STD clinic with culture proven chancroid , we compared the efficacy of azithromycin , administered as a single 1 g dose , with erythromycin 500 mg given 4 times daily for 7 days . Results : Cure rates were 89 % ( 73 of 82 ) in the azithromycin group and 91 % ( 41 of 45 ) in the erythromycin group . A failure to respond to treatment was associated with HIV-1 seropositivity and a lack of circumcision . Both regimens were well tolerated . Conclusions Azithromycin , given as a single 1 g oral dose , is an effective treatment for chancroid in men , and offers major prescribing advantages over erythromycin Tetracyclines and sulfonamides are no longer effective for the treatment of chancroid in many parts of the world . Rifampin and trimethoprim both possess in vitro activity against Haemophilus ducreyi , the causative agent of chancroid . In a r and omized , controlled study , 22 patients with H. ducreyi-positive genital ulcers received 600 mg of rifampin once daily for three days , and 32 patients received 600 mg of rifampin plus 160 mg of trimethoprim once daily for three days . Both regimens rapidly eradicated H. ducreyi from ulcers , with subsequent healing of ulcers and buboes . Two relapses of ulcers and one therapeutic failure were observed in the rifampin-trimethoprim group , whereas no relapses or failures were noted in the rifampin group . In addition , all of 16 H. ducreyi-negative ulcers responded rapidly to treatment with either regimen . In an uncontrolled , open study , 22 H. ducreyi-positive ulcers were treated with a single dose of rifampin ( 600 mg ) plus trimethoprim ( 160 mg ) . Ulcers and buboes resolved by day 14 in all but one patient . Thus , these short-course and single-dose regimens are effective against chancroid In a r and omized , controlled study , 55 patients with genital ulcerations , culture-positive for Haemophilus ducreyi , were treated with a single intramuscular injection of 2 g spectinomycin . A further 61 patients were treated with a five-day oral course of erythromycin base ( 500 mg , three times daily ) . Treatment failure occurred in seven patients who received spectinomycin ( 13 % ) , whilst no treatment failures were recorded among patients who received erythromycin . This difference in efficacy was statistically significant . In contrast , spectinomycin proved significantly more effective than erythromycin in the treatment of the lymphadenopathy associated with primary chancroid lesions
Output:
| AUTHORS ' CONCLUSIONS At present , the quality of the evidence on the effectiveness and safety of macrolides for treatment of H ducreyi infection in sexually active adults is low , implying that we are uncertain about the estimated treatment effect .
There is no statistically significant difference between the available therapeutic alternatives for the treatment of sexually active adults with genital ulcers compatible with chancroid .
Low quality evidence suggests that azithromycin could be considered as the first therapeutic alternative , based on their mono-dose oral administration , with a similar safety and effectiveness profile , when it is compared with long-term erythromycin use . |
MS213490 | ***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 Impairment of fertility is a common sequela of successful cancer treatment . Therefore , fertility preservation ( FP ) should be discussed with all young cancer patients . Decisions about FP are challenging . Patients wish more specific support and the first results concerning the helpfulness of decision aids ( DA ) were promising . Aside from describing the process of development and the content of an online DA in German , the objective of this study was to pilot test users ' satisfaction with the DA and its effect on knowledge about FP and decisional conflict ( DC ) . METHODS In this prospect i ve consecutive study , a control group ( n = 20 , fertility counseling ) was followed by and compared with an intervention group ( n = 20 , counseling and additional use of the DA , developed by an interdisciplinary team ) of recently diagnosed female cancer patients between 18 and 40 years . RESULTS Nearly all participants who applied the DA considered it helpful for decision-making and recommendable . Knowledge about FP was high with regard to FP techniques women went for . DC was moderate according to the mean score ( M = 27.92 , st and ard deviation = 13.27 ) and only in 20 % , the score was above the threshold for high DC . There was no difference between the control and intervention group for knowledge and DC . CONCLUSION The DA seems to serve as additional and well-accepted support tool in decision-making for patients and professionals . Referral to a reproductive specialist is crucial to warrant comprehensive information . These results need to be confirmed with the current ongoing r and omized controlled study Abstract This paper reports on the feasibility and preliminary effects of a decision aid ( DA ) about female fertility preservation ( FP ) . We conducted a pilot multicentre r and omized controlled trial of women with breast cancer aged 18–40 who were r and omized to brochures or the DA . Over 18 months , 62 women were eligible , of which 42 were invited by their healthcare provider ( 74 % ) to participate in the study . A total of 36 women signed up for participation and 26 ( 72 % ) were r and omized to brochures ( n = 13 ) or the DA ( n = 13 ) . In both groups , many women ( 87 % ) read the brochures and eight women used all available brochures . In the intervention group , 7/13 women logged in to the DA . Women who received brochures had slightly less decisional conflict , whereas knowledge improved in both groups . Our results indicate that both brochures about FP and a detailed DA have beneficial effects with regard to knowledge , but the DA seemed to introduce slightly more decisional conflict ( DC ) than the brochures . Although we encountered challenges with recruitment , our design and measurements seem feasible and the effects of the information material s seem promising , hence justifying conducting a larger study Background We aim ed to evaluate the effect of a decision aid ( DA ) with information only compared to a DA with values clarification exercise ( VCE ) , and to study the role of personality and information seeking style in DA-use , decisional conflict ( DC ) and knowledge . Methods Two scenario-based experiments were conducted with two different groups of healthy female participants . Dependent measures were : DC , knowledge , and DA-use ( time spent , pages viewed , VCE used ) . Respondents were r and omized between a DA with information only ( VCE- ) and a DA with information plus a VCE(VCE+ ) ( experiment 1 ) , or between information only ( VCE- ) , information plus VCE without referral to VCE(VCE+ ) , and information plus a VCE with specific referral to the VCE , requesting participants to use the VCE(VCE++ ) ( experiment 2 ) . In experiment 2 we additionally measured personality ( neuroticism/conscientiousness ) and information seeking style ( monitoring/blunting ) . Results Experiment 1 . There were no differences in DC , knowledge or DA-use between VCE- ( n=70 ) and VCE+ ( n=70 ) . Both DAs lead to a mean gain in knowledge from 39 % at baseline to 73 % after viewing the DA . Within VCE+ , VCE-users ( n=32 , 46 % ) reported less DC compared to non-users . Since there was no difference in DC between VCE- and VCE+ , this is likely an effect of VCE-use in a self-selected group , and not of the VCE per se . Experiment 2 . There were no differences in DC or knowledge between VCE- ( n=65 ) , VCE+ ( n=66 ) , VCE++ ( n=66 ) . In all groups , knowledge increased on average from 42 % at baseline to 72 % after viewing the DA . Blunters viewed fewer DA-pages ( R=0.38 , p<.001 ) . More neurotic women were less certain ( R=0.18 , p<.01 ) and felt less supported in decision making ( R=0.15 , p<.05 ) ; conscientious women felt more certain ( R=-0.15 , p<.05 ) and had more knowledge after viewing the DA ( R=0.15 , p<.05 ) . Conclusions Both DAs lead to increased knowledge in healthy population s making hypothetical decisions , and use of the VCE did not improve knowledge or DC . Personality characteristics were associated to some extent with DA-use , information seeking styles with aspects of DC . More research is needed to make clear recommendations regarding the need for tailoring of information provision to personality characteristics , and to assess the effect of VCE use in actual patients Background : Fertility is a priority for many young women with breast cancer . Women need to be informed about interventions to retain fertility before chemotherapy so as to make good quality decisions . This study aim ed to prospect ively evaluate the efficacy of a fertility-related decision aid ( DA ) . Methods : A total of 120 newly diagnosed early-stage breast cancer patients from 19 Australian oncology clinics , aged 18–40 years and desired future fertility , were assessed on decisional conflict , knowledge , decision regret , and satisfaction about fertility-related treatment decisions . These were measured at baseline , 1 and 12 months , and were examined using linear mixed effects models . Results : Compared with usual care , women who received the DA had reduced decisional conflict ( β=−1.51 ; 95%CI : −2.54 to 0.48 ; P=0.004 ) and improved knowledge ( β=0.09 ; 95%CI : 0.01–0.16 ; P=0.02 ) , after adjusting for education , desire for children and baseline uncertainty . The DA was associated with reduced decisional regret at 1 year ( β=−3.73 ; 95%CI : −7.12 to −0.35 ; P=0.031 ) , after adjusting for education . Women who received the DA were more satisfied with the information received on the impact of cancer treatment on fertility ( P<0.001 ) , fertility options ( P=0.005 ) , and rated it more helpful ( P=0.002 ) , than those who received st and ard care . Conclusion : These findings support widespread use of this DA shortly after diagnosis ( before chemotherapy ) among younger breast cancer patients who have not completed their families PURPOSE This study was undertaken to determine the effect , if any , of treatment for cancer diagnosed during childhood or adolescence on fertility . PATIENTS AND METHODS We review ed the fertility of female participants in the Childhood Cancer Survivor Study ( CCSS ) , which consisted of 5-year survivors , and a cohort of r and omly selected siblings who responded to a question naire . Medical records of all members of the cohort were abstract ed to obtain chemotherapeutic agents administered ; the cumulative dose of drug administered for several drugs of interest ; and the doses , volumes , and date s of administration of all radiation therapy . RESULTS There were 5,149 female CCSS participants , and there were 1,441 female siblings of CCSS participants who were age 15 to 44 years . The relative risk ( RR ) for survivors of ever being pregnant was 0.81 ( 95 % CI , 0.73 to 0.90 ; P < .001 ) compared with female siblings . In multivariate models among survivors only , those who received a hypothalamic/pituitary radiation dose > or = 30 Gy ( RR , 0.61 ; 95 % CI , 0.44 to 0.83 ) or an ovarian/uterine radiation dose greater than 5 Gy were less likely to have ever been pregnant ( RR , 0.56 for 5 to 10 Gy ; 95 % CI , 0.37 to 0.85 ; RR , 0.18 for > 10 Gy ; 95 % CI , 0.13 to 0.26 ) . Those with a summed alkylating agent dose ( AAD ) score of three or four or who were treated with lomustine or cyclophosphamide were less likely to have ever been pregnant . CONCLUSION This large study demonstrated that fertility is decreased among female CCSS participants . The risk factors identified may be utilized for pretreatment counseling of patients and their parents Introduction Women diagnosed with cancer and facing potentially sterilising cancer treatment have to make time-pressured decisions regarding fertility preservation with specialist fertility services while undergoing treatment of their cancer with oncology services . Oncologists identify a need for re sources enabling them to support women 's fertility preservation decisions more effectively ; women report wanting more specialist information to make these decisions . The overall aim of the ‘ Cancer , Fertility and Me ’ study is to develop and evaluate a new evidence -based patient decision aid ( PtDA ) for women with any cancer considering fertility preservation to address this unmet need . Methods and analysis This is a prospect i ve mixed- method observational study including women of reproductive age ( 16 years + ) with a new diagnosis of any cancer across two regional cancer and fertility centres in Yorkshire , UK . The research involves three stages . In stage 1 , the aim is to develop the PtDA using a systematic method of evidence synthesis and multidisciplinary expert review of current clinical practice and patient information . In stage 2 , the aim is to assess the face validity of the PtDA . Feedback on its content and format will be ascertained using question naires and interviews with patients , user groups and key stakeholders . Finally , in stage 3 the acceptability of using this re source when integrated into usual cancer care pathways at the point of cancer diagnosis and treatment planning will be evaluated . This will involve a quantitative and qualitative evaluation of the PtDA in clinical practice . Measures chosen include using count data of the PtDAs administered in clinics and accessed online , decisional and patient-reported outcome measures and qualitative feedback . Quantitative data will be analysed using descriptive statistics , paired sample t-tests and CIs ; interviews will be analysed using thematic analysis . Ethics and dissemination Research Ethics Committee approval ( Ref : 16/EM/0122 ) and Health Research Authority approval ( Ref : 194751 ) has been granted . Findings will be published in open access peer- review ed journals , presented at conferences for academic and health professional audiences , with feedback to health professionals and program managers . The Cancer , Fertility and Me patient decision aid ( PtDA ) will be disseminated via a diverse range of open-access media , study and charity websites , professional organisations and academic sources . External endorsement will be sought from the International Patient Decision Aid St and ards ( IPDAS ) Collaboration inventory of PtDAs and other relevant professional organisations , for example , the British Fertility Society . Trial registration number NCT02753296 ; pre- results The aim of this prospect i ve study is to assess the reliability and validity of a multi-dimensional measure of informed choice ( MMIC ) . Participants were 225 pregnant women in two general hospitals in the UK , women receiving low-risk results following serum screening for Down syndrome . The MMIC was administered before testing and the Ottawa Decisional Conflict Scale was administered 6 weeks later . The component scales of the MMIC , knowledge and attitude , were internally consistent ( alpha values of 0.68 and 0.78 , respectively ) . Those who made a choice categorised as informed using the MMIC rated their decision 6 weeks later as being more informed , better supported and of higher quality than women whose choice was categorised as uninformed . This provides evidence of predictive validity , whilst the lack of association between the MMIC and anxiety shows construct ( discriminant ) validity . Thus , the MMIC has been shown to be psychometrically robust in pregnant women offered the choice to undergo prenatal screening for Down syndrome and receiving a low-risk result . Replication of this finding in other groups , facing other decisions , with other outcomes , should be assessed in future research OBJECTIVES We conducted pilot studies of the feasibility and efficacy of an interactive , computerized educational tool , Banking on Fatherhood ( BOF ) . METHODS Two small r and omized trials were conducted , with 20 male cancer patients eligible to bank sperm in Study 1 and 19 oncology fellows or residents in Study 2 . In each trial , half of the subjects viewed BOF before completing question naires , and half viewed it afterward . Outcome measures included a knowledge test in both trials and a Decisional Conflict scale in the patient trial . All participants , plus a panel of 10 experts , ultimately viewed BOF and completed a form evaluating its usability and value . RESULTS Patients who completed question naires after viewing BOF had significantly less decisional conflict about banking sperm than those who had not viewed it ( P=0.0065 ) , but knowledge scores were not significantly different between groups . Physicians who filled out question naires after viewing BOF scored significantly higher on the knowledge test ( P<0.006 ) . Patients , physicians and experts rated BOF as easy to use , informative and addressing important psychosocial concerns , with videos and animations adding to the value of the educational tool . CONCLUSION Pilot studies suggest that BOF is a feasible intervention that could enhance decisions about sperm banking . Research with larger groups is needed to vali date its effectiveness
Output:
| PtDAs were shown to significantly increase fertility preservation knowledge and decrease decisional conflict .
Overall satisfaction with decision aids was high .
PtDAs can serve as effective complements to current fertility counselling practice s by increasing information satisfaction and decision-making outcomes . |
MS213491 | ***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 Investigate hemodynamic responses of resistance exercise ( RE ) with moderate load ( i.e. , international guidelines for RE of patients ) versus RE with high load in patients with coronary artery disease ( CAD ) . METHODS Medically stable male ( n = 11 ) and female patients ( n = 4 ) treated with PCI or percutaneous coronary intervention , or coronary artery bypass surgery a minimum of 6 months before this study , performed three sets of 15RM and 4RM RE in a r and omized order on separate days . Beat-to-beat systolic ( SBP ) , diastolic ( DBP ) blood pressure , heart rate ( HR ) , stroke volume ( SV ) , cardiac output ( CO ) , and systemic vascular resistance ( SVR ) were monitored at preexercise , and continuously during RE . RESULTS Compared with preexercise , SBP and DBP ( mean of three sets ) increased by 12 % to 13 % ( both ; P < 0.001 ) and 35 % to 40 % after 15RM RE ( both ; P < 0.001 ) . 15RM SBP and DBP were higher than 4RM SBP and DBP ( both ; P < 0.001 ) . The SBP of the fourth repetition of 15 RM RE was similar to the SBP of the fourth repetition of 4RM RE . Compared with preexercise , SV increased moderately after 4RM and 15 RM RE , respectively ( both , P < 0.001 ) . HR increased more after 15RM compared with 4RM RE ( P < 0.05 ) ; thus , higher CO after 15RM ( compared with 4RM RE ; P < 0.05 ) was mainly caused by higher HR . SVR decreased by 15 % ( P < 0.001 ) and 50 % ( P < 0.01 ) after 4RM and 15RM RE . CONCLUSIONS SBP and DBP increased significantly more during moderate load RE ; thus , the magnitude of the external load is not the prime determinant of the pressure response during RE . If management of blood pressure is of concern , high load/low rep RE is preferable to medium load/high rep RE OBJECTIVE : The aim of this study was to describe blood pressure responses during resistance exercise in hypertensive subjects and to determine whether an exercise protocol alters these responses . INTRODUCTION : Resistance exercise has been recommended as a complement for aerobic exercise for hypertensive patients . However , blood pressure changes during this kind of exercise have been poorly investigated in hypertensives , despite multiple studies of normotensives demonstrating significant increases in blood pressure . METHODS : Ten hypertensive and ten normotensive subjects performed , in r and om order , two different exercise protocol s , composed by three sets of the knee extension exercise conducted to exhaustion : 40 % of the 1-repetition maximum ( 1RM ) with a 45-s rest between sets , and 80 % of 1RM with a 90-s rest between sets . Radial intra-arterial blood pressure was measured before and throughout each protocol . RESULTS : Compared with normotensives , hypertensives displayed greater increases in systolic BP during exercise at 80 % ( + 80±3 vs. + 62±2 mmHg , P<0.05 ) and at 40 % of 1RM ( + 75±3 vs. + 67±3 mmHg , P<0.05 ) . In both exercise protocol s , systolic blood pressure returned to baseline during the rest periods between sets in the normotensives ; however , in the hypertensives , BP remained slightly elevated at 40 % of 1RM . During rest periods , diastolic blood pressure returned to baseline in hypertensives and dropped below baseline in normotensives . CONCLUSION : Resistance exercise increased systolic blood pressure considerably more in hypertensives than in normotensives , and this increase was greater when lower-intensity exercise was performed to the point of exhaustion BACKGROUND Resistance training has been introduced in cardiac rehabilitation to give more benefit than traditional training . Haemodynamic evaluation of cardiac patients to resistance training has generally consisted of continuous HR monitoring and discontinuous blood pressure measurements . DESIGN AND METHODS Blood pressure ( BP ) and heart rate ( HR ) responses to resistance training were evaluated using continuous monitoring ( Finapres ) during low ( four sets of 17 repetitions at 40 % of the one-repetition maximum strength [ 1-RM ] ) and high intensity resistance training ( four sets of 10 repetitions at 70 % of 1-RM ) on a leg extension machine in 14 patients who participated in a rehabilitation programme . Work volume was identical in the low- and high-level resistance training . RESULTS The HR and systolic blood pressure ( SBP ) during low intensity resistance training were always larger than during high intensity ( P<0.001 ) . Peak SBP increased from set 1 to set 3 and 4 during both low and high intensity resistance training ( P<0.05 ) . Peak HR was larger in set 4 ( 95+/-11 bpm ) than in set 1 only during low intensity resistance training ( 91+/-12 bpm ) ( P<0.05 ) . One-minute recovery periods did not allow a return to baseline HR and SBP during both low and high intensity modalities . CONCLUSIONS The SBP and HR responses to resistance training are related to the duration of exercise . Sets with < or = 10 repetitions of high intensity should be preferred to longer sets with low intensity . Pauses between exercise sets should exceed 1 min . Blood pressure should be measured during the last repetitions of the exercise set BACKGROUND The aim of this study was to compare the acute hemodynamic and cardiovascular responses of high load/low repetition resistance training ( RT ) to low load/high repetition RT . METHODS Thirteen healthy men performed four sets of 4 repetition maximum ( RM ) and 20RM leg-extensions without breath-holding . The RT was conducted in a r and omized order and with 48 hours between bouts . Non-invasive beat-to-beat systolic and diastolic blood-pressure ( SBP/DBP ) was measured on the finger , while non-invasive cardiac output ( CO ) was assessed beat-to-beat by impedance-cardiography . RESULTS Mean±SD resting SBP/DBP and CO were 126±14/73±9 mmHg and 5.6±9 L min-1 , respectively . Exercise SBP/DBP values increased to 154±22/99 ±18 and 203±33/126±19 mmHg following 4RM and 20RM RT , respectively ( compared to rest , all ; P<0.001 ) , and 20RM SBP/DBP values were higher than 4RM values ( both , P<0.001 ) . The SBP increased from the first to the fourth set of exercise following the 20RM load ( P<0.01 ) , but not so for the 4RM load . Exercise SBP/DBP values following the 4th rep of 20RM exercise ( 154±18/91±14 ) , was similar to the 4RM values , but different to the 20th rep of the 20 RM loading ( both ; P<0.001 ) . CO increased to 10.8±2.6 and 13.9±2.2 L min-1 , following 4RM and 20RM RT , respectively ( compared to rest , both ; P<0.001 ) and 20RM CO was higher than 4RM CO ( P<0.01 ) . CONCLUSIONS 20RM RT result ed in higher blood-pressure than 4RM RT when performed to voluntary exhaustion . Differences in hemodynamic responses seems to be related to training duration and not to difference in loading We examined the neuromuscular adaptations following 3 and 6 weeks of 80 vs. 30 % one repetition maximum ( 1RM ) resistance training to failure in the leg extensors . Twenty-six men ( age = 23.1 ± 4.7 years ) were r and omly assigned to a high- ( 80 % 1RM ; n = 13 ) or low-load ( 30 % 1RM ; n = 13 ) resistance training group and completed leg extension resistance training to failure 3 times per week for 6 weeks . Testing was completed at baseline , 3 , and 6 weeks of training . During each testing session , ultrasound muscle thickness and echo intensity , 1RM strength , maximal voluntary isometric contraction ( MVIC ) strength , and contractile properties of the quadriceps femoris were measured . Percent voluntary activation ( VA ) and electromyographic ( EMG ) amplitude were measured during MVIC , and during r and omly ordered isometric step muscle actions at 10–100 % of baseline MVIC . There were similar increases in muscle thickness from Baseline to Week 3 and 6 in the 80 and 30 % 1RM groups . However , both 1RM and MVIC strength increased from Baseline to Week 3 and 6 to a greater degree in the 80 % than 30 % 1RM group . VA during MVIC was also greater in the 80 vs. 30 % 1RM group at Week 6 , and only training at 80 % 1RM elicited a significant increase in EMG amplitude during MVIC . The peak twitch torque to MVIC ratio was also significantly reduced in the 80 % , but not 30 % 1RM group , at Week 3 and 6 . Finally , VA and EMG amplitude were reduced during submaximal torque production as a result of training at 80 % 1RM , but not 30 % 1RM . Despite eliciting similar hypertrophy , 80 % 1RM improved muscle strength more than 30 % 1RM , and was accompanied by increases in VA and EMG amplitude during maximal force production . Furthermore , training at 80 % 1RM result ed in a decreased neural cost to produce the same relative submaximal torques after training , whereas training at 30 % 1RM did not . Therefore , our data suggest that high-load training results in greater neural adaptations that may explain the disparate increases in muscle strength despite similar hypertrophy following high- and low-load training programs PURPOSE The purpose of this study was to compare resistance training ( RT ) ( one set vs three sets ) combined with aerobic training ( AT ) versus AT alone in persons with coronary artery disease . METHODS Subjects ( n = 72 ) were r and omized to AT ( 5 d x wk(-1 ) ) or combined AT ( 3 d x wk(-1 ) ) with either one set ( AT/RT1 ) or three sets ( AT/RT3 ) of RT performed 2 d x wk(-1 ) . VO2peak , ventilatory anaerobic threshold ( VAT ) , strength and endurance , body composition , and adherence were measured before and after 29 wk of training . RESULTS Fifty-three subjects ( mean + /- SEM age 61 + /- 2 ) completed the training . The increase from baseline in VO2peak ( L x min(-1 ) ) averaged 11 % for AT ( P < 0.05 ) , 14 % for AT/RT1 ( P < 0.01 ) , and 18 % for AT/RT3 ( P < 0.001 ) , however , the difference between groups was not significant . VAT improved significantly in the AT/RT3 group only ( P < 0.05 ) . The AT/RT3 group gained more lean mass than the AT group ( 1.5 versus 0.4 kg , P < 0.01 ) , yet gains between AT/RT1 and AT were similar ( P = 0.2 ) . Only AT + RT groups demonstrated a reduction in body fat ( P < 0.05 ) . Strength and endurance increased more in the AT + RT groups than AT alone ( P < 0.05 ) . Adherence to number of sets performed was lower in AT/RT3 than AT/RT1 ( P < 0.02 ) . CONCLUSIONS Combined AT + RT yields more pronounced physiological adaptations than AT alone and appears to be superior in producing improvements in VO2peak , muscular strength and endurance , and body composition . The data support the use of multiple set RT for patients desiring an increased RT stimulus which may further augment parameters that affect VO2peak , VAT , lower body endurance , and muscle mass in a cardiac population
Output:
| When added to endurance training , dynamic strength training leads to significantly greater improvements in peripheral muscle strength and power output in patients with cardiovascular disease , which may be relevant to enhance the patient ’s prognosis .
Moreover , multiple studies report that high-intensity strength training causes fewer increments in (intra-)arterial blood pressure and cardiac output , as opposed to low-intensity strength training , thus potentially pointing towards sufficient medical safety for the cardiovascular system . |
MS213492 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Introduction Immune thrombocytopenia ( ITP ) is an immune disorder commonly presents as isolated thrombocytopenia . Generally corticosteroids are the main treatment of ITP . This study was design ed to evaluate effectiveness of high dose dexamethasone comparing conventional corticosteroid therapy in the treatment of ITP . Material s and methods In a r and omized prospect i ve study , sixty adult patients with newly diagnosed primary symptomatic ITP ( Platelet count < 20,000 ) were evaluated . Patients divided into two groups . In group A , thirty patients ( mean age of 24.9 years ) received Dexamethasone 40 mg/IV/daily for four days ( 10 mg/q6h ) ; and then Prednisolone 1 mg/kg/day/PO with rapid tapering of prednisolone ( 10 mg/week ) . From the other h and , in group B , thirty patients ( mean age of 27.2 years ) were treated with Prednisolone 1 mg/kg/day/PO for four weeks , then the drug tapered weekly . Results All the patients in group A showed favorable response within the first seven days , 27 cases presented complete response ( CR ) and three cases revealed response ( R ) . In group B , 11 cases had CR , 13 cases showed R and six cases had No response ( NR ) . After three months , rates of CR were 80 % and 23.3 % in group A and B ; respectively . Responses were 16.7 % and 33.3 % , NRs were 6.6 % and 43.3 % in group A and B ; respectively ( P < 0.0001 ) . After 6 months , CR was 73.3 % vs.16.7 % , and R was 16.7 % vs.36.7 % and NR was 10 % vs. 46.7 % in group A and B ; respectively ( P < 0.0001 ) . After 12 months , there was no change in response rate in group A , but in group B 53 % were non responsive , 40 % showed R ( chronic ITP ) and complete response was observed only in 6.7 % ( P < 0.0001 ) . Three cases in group A and 12 cases in group B had needed splenectomy ( P < 0.00002 ) . Conclusion We showed that high dose dexamethasone is more effective than conventional steroid therapy in newly diagnosed ITP as initial treatment with less relapses and toxicities We report the results of a r and omized clinical trial of two different coricosteroids ( prednisone versus deflazacort ) in patients affected by autoimmune thrombocytopenic purpura ( ATP ) . We have evaluated the efficacy of the two steroids on platelet count , antiplatelet antibodies , lymphocyte subsets and the occurrence of side effects . Twenty-seven patients were evaluable : 13 were treated with PDN and 14 with DFC . After 24 weeks of treatment , 4/12 ( 33 % ) , subjects treated with PDN were refractory while complete responses were obtained in 2/12 ( 17 % ) and partial responses in 6/12 ( 50 % ) . Among patients treated with DFC , 4/11 ( 36 % ) were considered as refractory , 2/11 ( 18 % ) had a complete response and 5/11 ( 46 % ) a partial response . A statistically significant decrease of antiplatelet antibodies was recorded in both groups after 4 weeks of therapy , but only in subjects receiving PDN did the reduction last until the 24th week . We observed an increase of T lymphocyte subsets ( CD3 , CD2 , CD4 , CD8 ) in absolute number , due to an increase in circulating lymphocytes , after 4 weeks . No substantial modifications were observed in these population s regarding the percentage or the CD4/CD8 ratio . After 24 weeks , 91 % ( 10/11 ) of patients treated with PDN presented an increase of body weight and 1 had a stable increase in blood pressure . Among the subjects treated with DFC , 64 % ( 7/11 ) showed an increase of body weight after the same follow-up . In conclusion , no difference was observed the two steroids studied In idiopathic thrombocytopenic purpura ( ITP ) , corticosteroids have been widely recognized as the most appropriate first-line treatment , even if the best therapeutic approach is still a matter of debate . Recently , a single high-dose dexamethasone ( HD-DXM ) course was administered as first-line therapy in adult patients with ITP . In this paper we show the results of 2 prospect i ve pilot studies ( monocentric and multicentric , respectively ) concerning the use of repeated pulses of HD-DXM in untreated ITP patients . In the monocenter study , 37 patients with severe ITP , age at least 20 years and no more than 65 years , were enrolled . HD-DXM was given in 4-day pulses every 28 days , for 6 cycles . Response rate was 89.2 % ; relapse-free survival ( RFS ) was 90 % at 15 months ; long-term responses , lasting for a median time of 26 months ( range 6 - 77 months ) were 25 of 37 ( 67.6 % ) . In the multicenter study , 95 patients with severe ITP , age at least 2 years and no more than 70 years , were enrolled . HD-DXM was given in 4-day pulses every 14 days , for 4 cycles ; 90 patients completed 4 cycles . Response rate ( 85.6 % ) was similar in patients classified by age ( < 18 years , 36 of 42=85.7 % ; > or=18 years , 41 of 48=85.4 % , P = not significant ) , with a statistically significant difference between the second and third cycle ( 75.8 % vs 89 % , P=.018 ) . RFS at 15 months 81 % ; long-term responses , lasting for a median time of 8 months ( range 4 - 24 months ) were 67 of 90 ( 74.4 % ) . In both studies , therapy was well tolerated . A schedule of 3 cycles of HD-DXM pulses will be compared with st and ard prednisone therapy ( eg , 1 mg/kg per day ) in the next r and omized Gruppo Italiano Malattie EMatologiche dell'Adulto ( GIMEMA ) trial BACKGROUND Treatment of adults with autoimmune thrombocytopenic purpura ( AITP ) is based more on individual experience than on results of controlled studies . We compared intravenous immunoglobulin with high-dose methylprednisolone in untreated adults with severe AITP and assessed efficacy of subsequent oral steroids compared with placebo . Primary outcome was number of days with platelet count greater than 50 x 10(9)/L within the first 21 days . METHODS We did a r and omised multicentre trial based on a 232 design . 122 adults with severe AITP ( platelet count < or = 20 x 10(9)/L ) were r and omly assigned to receive either intravenous immunoglobulin or high-dose methylprednisolone on days 1 - 3 ( r and omisation A ) , and then to receive either oral prednisone or placebo ( r and omisation B ) on days 4 - 21 . Analysis was by intention to treat . FINDINGS Six patients were excluded from the analysis . The number of days on which platelet counts were above 50 x 10(9)/L was 18 in 56 patients receiving intravenous immunoglobulin and 14 in 60 receiving high-dose methylprednisolone ( p=0.02 ) . Percentage of patients who had platelet counts over 50 x 10(9)/L on days 2 and 5 was 7 % and 79 % , respectively , in the intravenous immunoglobulin group compared with 2 % and 60 % , respectively , in the high-dose methylprednisolone group ( p=0.04 ) . During the second treatment period , prednisone was more effective than placebo for all short-term endpoints . Patients who received intravenous immunoglobulin and prednisone had platelet count greater than 50 x 10(9)/L for 18.5 days ( p=0.005 ) , and those treated with high-dose methylprednisolone and prednisone had this count for 17.5 days . INTERPRETATION Intravenous immunoglobulin and oral prednisone seems to be more effective than high-dose methylprednisolone and oral prednisone in adults with severe AITP , although the latter treatment is effective and well tolerated 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 T-cell dysregulation and T-cell-related cytokine abnormalities are involved in the pathogenesis of immune thrombocytopenia ( ITP ) . One of our previous studies showed that elevated IL-22 correlated to Th1 and Th22 cells plays an important role in the immunopathogenesis of ITP . In this study , we aim ed to investigate the effects of high-dose dexamethasone ( HD-DXM ) on IL-22 production and on the IL-22-producing T-cell subsets in ITP patients . Methods IL-22 plasma levels and the percentages of Th1 , Th17 , and Th22 cells were determined by enzyme-linked immunosorbent assay and flow cytometry in 25 ITP patients receiving DXM 40 mg/day for 4 consecutive days . Results Plasma IL-22 concentrations and the percentages of Th1 and Th22 cells were significantly increased in pre-therapy patients relative to controls ( P < 0.05 ) , but the percentage of Th17 cells was not . HD-DXM administration reduced IL-22 production and corrected the imbalance between Th1 and Th22 subsets . IL-22 levels were positively correlated with Th1 and Th22 cells in ITP patients before and after HD-DXM treatment . Conclusion These results suggest that HD-DXM may regulate the production of IL-22 in ITP , possibly by correcting Th1 and Th22 polarization This study compared the efficacy and safety of high-dose dexamethasone ( HD-DXM ) and conventional prednisone ( PDN ) on the largest cohort to date as first-line strategies for newly diagnosed adult primary immune thrombocytopenia ( ITP ) . Patients enrolled were r and omized to receive DXM 40 mg/d for 4 days ( n = 95 , nonresponders received an additional 4-day course of DXM ) or prednisone 1.0 mg/kg daily for 4 weeks and then tapered ( n = 97 ) . One or 2 courses of HD-DXM result ed in a higher incidence of overall initial response ( 82.1 % vs 67.4 % , P = .044 ) and complete response ( 50.5 % vs 26.8 % , P = .001 ) compared with prednisone . Time to response was shorter in the HD-DXM arm ( P < .001 ) , and a baseline bleeding score ≥8 was associated with a decreased likelihood of initial response . Sustained response was achieved by 40.0 % of patients in the HD-DXM arm and 41.2 % in the PDN arm ( P = .884 ) . Initial complete response was a positive indicator of sustained response , whereas presence of antiplatelet autoantibodies was a negative indicator . HD-DXM was generally tolerated better . We concluded that HD-DXM could be a preferred corticosteroid strategy for first-line management of adult primary ITP . This study is registered at www . clinical trials.gov as # NCT01356511 Background : To tackle the problems associated with high-dose dexamethasone ( HD-DXM ) in patients with immune thrombocytopenia ( ITP ) . Aim : To compare the efficacy of HD-DXM with or without low-dose dexamethasone maintenance in untreated ITP patients . Results : Dexamethasone ( 40 mg/day ) was given in 4-day pulses every 14 days for 3 cycles in 61 patients with ITP . Among them , 30 cases were given dexamethasone ( 0.035 mg/kg per day ) for maintenance between pulsed HD-DXM and after 3 HD-DXM courses ( HD-DXM-M group ) and another 31 cases did not receive dexamethasone maintenance ( HD-DXM-nM group ) . The control group comprised the patients who received prednisone ( prednisone group ) . The following results were obtained : ( 1 ) at the end of the 3rd cycle , the overall response rate ( ORR ) was higher in the HD-DXM group than in the prednisone group ; ( 2 ) the ORR of the HD-DXM group peaked after the 3rd cycle ; ( 3 ) the ORR after each course was higher in the HD-DXM-M group than in the HD-DXM-nM group ; ( 4 ) in the 12th month after HD-DXM discontinuation , the relapse rate of the HD-DXM-M group was lower than that of the other groups ( prednisone and HD-DXM-nM ) . Conclusion : Treatment with 3 cycles of HD-DXM pulses with low-dose dexamethasone maintenance is an
Output:
| No difference in initial platelet count response was observed with different high-dose corticosteroid regimens in children .
INTERPRETATION In adults with previously untreated immune thrombocytopenia , high-dose dexamethasone did not improve durable platelet count responses compared with st and ard-dose prednisone . |
MS213493 | ***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: Short-term interferon treatment of serum hepatitis B e antigen (HBeAg)-negative carriers with serum hepatitis B virus ( HBV ) DNA and histological features of chronic hepatitis B has been largely unsuccessful . In a pilot study of long-term treatment , 42 such patients were r and omly assigned to 6 million units of interferon alfa 2b ( IFN-alpha2b ) three times per week for 24 consecutive months ( n = 21 , 4 with cirrhosis ) or to no therapy ( n = 21 , 3 with cirrhosis ) . Five patients ( 24 % ) discontinued therapy because of treatment-related adverse reactions . Serum levels of alanine transaminase ( ALT ) became persistently normal and HBV DNA undetectable by dot-blot assay in 8 patients receiving interferon and in 2 untreated controls ( 38 % vs. 10 % ; P = .03 ) . Hepatitis flare-ups disappeared in 17 patients during therapy compared with 6 controls ( 81 % vs. 29 % ; P < .001 ) . During a median period of 22 months after interferon was stopped , 2 treated patients ( 10 % ) lost serum hepatitis B surface antigen ( HBsAg ) and seroconverted to antibodies to hepatitis B surface antigen ( anti-HBs ) . Serum ALT remained persistently normal and HBV DNA undetectable by dot-blot assay in 6 initial responders and 1 initial nonresponder , compared with none of the 21 untreated controls ( sustained response : 33 % vs. 0 ; P < .001 ) . Comparative analysis of pre- and posttreatment liver biopsies showed that mean Knodell scores dropped in the treated group ( 10.3 to 5.3 ; P = .01 ) , but not in the untreated group ( 9.3 to 9.8 ; not significant ) . In conclusion , a 24-month course of treatment with 6 MU IFN-alpha2b was well tolerated by most patients , led to sustained suppression of HBV in one third , and attenuated hepatitis in 81 % of patients Current therapies for chronic hepatitis B ( CHB ) have a number of limitations , and better treatment options are needed . Peginterferon alpha-2a ( 40 kDa ) is superior to conventional interferon alpha-2a in the treatment of chronic hepatitis C. This is the first report on peginterferon alpha-2a ( 40 kDa ) in the treatment of CHB . In this phase II study , 194 patients with CHB not previously treated with conventional interferon-alpha were r and omized to receive weekly subcutaneous doses of peginterferon alpha-2a ( 40 kDa ) 90 , 180 or 270 microg , or conventional interferon alpha-2a 4.5 MIU three times weekly . Twenty-four weeks of therapy were followed by 24 weeks of treatment-free follow-up . All subjects were assessed for loss of hepatitis B e antigen ( HBeAg ) , presence of hepatitis B antibody ( anti-HBe ) , suppression of hepatitis B virus ( HBV ) DNA , and normalization of serum alanine transaminase ( ALT ) after follow-up . At the end of follow-up , HBeAg was cleared in 37 , 35 and 29 % of patients receiving peginterferon alpha-2a ( 40 kDa ) 90 , 180 and 270 microg , respectively , compared with 25 % of patients on conventional interferon alpha-2a . The combined response ( HBeAg loss , HBV DNA suppression , and ALT normalization ) of all peginterferon alpha-2a ( 40 kDa ) doses combined was twice that achieved with conventional interferon alpha-2a ( 24%vs 12 % ; P = 0.036 ) . All treatment groups were similar with respect to frequency and severity of adverse events . These results indicate that peginterferon alpha-2a ( 40 kDa ) is superior in efficacy to conventional interferon alpha-2a in chronic hepatitis B based on clearance of HBeAg , suppression of HBV DNA , and normalization of ALT A r and omized controlled trial of recombinant interferon alfa-2b has been initiated in patients with chronic active hepatitis who were negative for serum hepatitis B e antigen but positive for serum hepatitis B virus DNA and hepatitis B core antigen expression in the liver . Twenty-five patients received interferon alfa-2b 3 million units thrice weekly for 14 - 16 weeks and 25 served as untreated controls . Seventeen patients in the treatment and 18 in the control group have already completed a 12-month period of observation . Interferon alfa-2b was well tolerated by all patients . At the end of therapy , complete responses , defined as disappearance of hepatitis B virus DNA from serum and return of alanine aminotransferase to normal , were observed in 10 ( 59 % ) of the 17 treated patients compared to none in the control group ( p less than 0.01 ) . Twelve months after the onset of interferon alfa-2b therapy , 11 ( 65 % ) of the 17 treated patients were complete responders compared to 2 ( 11 % ) of 18 in the control group ( p less than 0.01 ) . Fifty per cent ( 4/8 ) of complete responders to interferon alfa-2b therapy , followed for 16 - 24 months , experienced reactivations of hepatitis B virus replication with reappearance of serum hepatitis B virus DNA and a return of serum alanine aminotransferase activity . The response to interferon alfa-2b therapy appeared to be independent of pre-treatment serum alanine aminotransferase and hepatitis B virus DNA levels In a multicentre trial , 82 patients known to be hepatitis B e antigen and hepatitis B virus DNA positive for at least 1 year , with elevated serum alanine aminotransferase levels and chronic liver lesions on biopsy , were r and omized to receive either recombinant interferon alfa-2a at a dose of 4.5 million units thrice weekly for 4 months or no treatment . At the end of therapy , viral DNA clearance and aminotransferase normalization were significantly ( p less than 0.05 ) more frequent in treated patients than in controls . After 16 months ' follow up , the difference was still significant for hepatitis B e antigen clearance and transaminase normalization . Hepatitis B virus DNA reactivation was observed during follow up in 43 % of treated patients and 50 % of controls . Improvements in liver inflammation were observed in patients on interferon . High pre-treatment serum aminotransferase levels , female sex and a low score for fibrosis in the initial biopsy were predictive factors significantly ( p less than 0.05 ) associated with termination of hepatitis B virus replication in treated cases . These results indicate that interferon is effective in inducing clearance of HBV from serum and improvement of biochemical and histological parameters of liver disease . However , a more prolonged regimen of therapy may be required to obtain stable suppression of hepatitis B virus replication A total of 58 patients with histologically confirmed chronic viral hepatitis B and presence of hepatitis B surface antigen and hepatitis B virus DNA ( HBV DNA ) in the serum were r and omized in a prospect ively controlled trial . Thirty patients were treated with 3 megaunits of recombinant interferon alfa-2b ( INTRON A , R Schering-Plough , Essex Corporation ) subcutaneously thrice weekly for 4 months . Twenty-eight controls received no treatment . The post-treatment follow-up period consisted of 6 months . Twenty-eight treated patients and 27 controls completed the protocol . One female patient of the treatment group showed a complete response , and eight other treated patients ( 32 % ) showed a partial response to therapy . Three patients in the control group ( 11 % ) lost hepatitis B e antigen and HBV DNA spontaneously . This finding is statistically significant ( p less than 0.05 ) . The elimination of hepatitis B virus markers from the serum was associated with a normalization of aminotransferase activities in the serum . Reactivation of hepatitis was not observed after seroconversion To determine the antiviral effect of recombinant-interferon (rIFN)-alpha in hepatitis B virus ( HBV ) chronic infection , a controlled study was carried out . A total of 20 HBsAg chronic carriers ( 18 chronic active hepatitis and 2 chronic persistent hepatitis ) were included . All of them had remained HBeAg , HBV-DNA and HBV-DNA polymerase ( HBV-DNAp ) positive at least six months before treatment . The patients were r and omly assigned to two groups : control ( n = 10 ) , and treatment ( n = 10 ) . A dose of 5.5 megaunits of rIFN-alpha/m2 body surface was administered every day for 21 days ( induction ) and twice a week for six months thereafter ( maintenance ) . No basal differences were observed between the two groups . No case of intolerable toxicity was observed . One treated patient died in a car crash in the second month . At the end of the first week of therapy , 7/10 ( 70 % ) of the treated patients became HBV-DNAp negative . However , in the fifth month only 2 patients remained HBV-DNAp negative and also became HBV-DNA and HBeAg negative . In contrast , no changes in viral markers among control cases were observed . In conclusion , rIFN-alpha has an antiviral effect on chronic HBV infection ; however , the induction plus maintenance schedule is not useful to obtain a permanent effect Interferon alfa ( IFN‐α ) is the primary treatment for chronic hepatitis B. The st and ard duration of IFN‐α therapy is considered 16 weeks ; however , the optimal treatment length is still poorly defined . We evaluated the efficacy and acceptability of prolonged IFN‐α treatment in patients with chronic hepatitis B. To investigate whether treatment prolongation could enhance the rate of hepatitis B e antigen ( HBeAg ) seroconversion , we conducted a prospect i ve , controlled , multicenter trial in which all patients were treated with a st and ard regimen of 10 million units IFN‐α 3 times per week over 16 weeks . Patients who were still HBeAg‐positive after 16 weeks of therapy were r and omized to prolongation of the identical regimen up to 32 weeks ( prolonged therapy ) or discontinuation of treatment ( st and ard therapy ) . Among the 162 patients who entered the study , 27 ( 17 % ) were HBeAg‐negative after the first 16 weeks of treatment , and 118 were r and omized to st and ard or prolonged therapy . After r and omization , a response ( HBeAg seroconversion and sustained hepatitis B virus [HBV]‐DNA negativity ) was observed in 7 of the 57 ( 12 % ) patients assigned to st and ard therapy versus 17 of the 61 ( 28 % ) patients assigned to prolonged therapy ( P = .04 ) . A low level of viral replication after 16 weeks of treatment , as indicated by serum HBV‐DNA values under 10 pg/mL , was found to be the only independent predictor of response ( 52 % vs. 0 % ; P < .001 ) during prolonged therapy . The prolonged IFN‐α schedule was well tolerated in the large majority of patients . In chronic hepatitis B , prolongation of IFN‐α therapy up to 32 weeks is superior to a st and ard course of 16 weeks . Those patients who exhibit a low level of viral replication at the end of the st and ard regimen benefit most from prolonged treatment 72 Chinese patients who had been positive for hepatitis B surface antigen ( HBsAg ) and hepatitis B e antigen ( HBeAg ) for more than six months with stable serum hepatitis B virus DNA were r and omised to receive recombinant alpha 2-interferon at doses of 2.5 , 5 , or 10 X 10(6 ) U/m2 intramuscularly thrice weekly for 12 - 24 weeks , or no treatment . 6 ( 11 % ) of 54 treated and 1 ( 6 % ) of 18 control patients became HBeAg-negative at the end of therapy or after 24 weeks of follow-up . 9 ( 17 % ) of treated but none of the control patients became HBeAg-negative between completion of therapy and 12 months . Reactivation of HBV replication subsequently occurred in 7 ( 13 % ) of the treated patients and in 1 control . Thus , sustained clearance of HBeAg was achieved only in 8 ( 15 % ) of treated patients at 12 months . Between 12 and 24 months 3 ( 9 % ) of treated patients and 1 control became negative for HBeAg . None of the patients became HBsAg-negative . alpha 2-interferon in the dose regimen used has little long-term effect in the suppression of HBV replication in Chinese patients with chronic HBV infection Hepatitis B virus ( HBV ) infection after liver transplantation ( LT ) may lead to severe and rapidly progressive graft failure . Antiviral treatment may be of benefit in selected patients with recurrent hepatitis B post-LT . The aim of this prospect i ve open-label study is to determine the safety and efficacy of lamivudine in 33 liver transplant recipients with active HBV infection . The median time from LT to study enrollment was 51 months , all patients were hepatitis B surface antigen positive , and 75 % and 94
Output:
| Presence or absence of HBeAg and pre-treatment alanine aminotransferase ( ALT ) levels were considered important factors in the initial therapeutic indication .
Treatment with conventional interferon enables lasting disease inactivation and can result in HBsAg seroconversion .
PEG2a showed better efficacy than interferon and LAM and similar side effects to interferon .
LAM presents advantages such as its sensitivity in the HbeAg-negative phenotype , while its main disadvantage is the development of resistance |
MS213494 | ***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 dexmedetomidine infusion could reduce opioid consumption and opioid-related side effects after uterine artery embolization ( UAE ) . MATERIAL S AND METHODS Fifty patients undergoing UAE for symptomatic leiomyomas or adenomyosis were r and omized into two groups . In 25 patients , dexmedetomidine infusion was started at 0.2 μg/kg/h at 30 minutes before the procedure , followed by 0.4 μg/kg/h for 6 hours after the procedure . In another 25 patients ( control group ) , volume-matched normal saline solution was administered . Both groups received fentanyl-based intravenous patient-controlled analgesia ( PCA ; fentanyl 10 μg/h with a bolus dose of 20 μg ) during the 24 hours after the procedure . Nonspherical polyvinyl alcohol particles were used . Pain scores , fentanyl consumption , need for additional analgesics , and side effects were assessed for 24 hours after UAE . RESULTS Compared with the control group , patients in the dexmedetomidine group required 28 % less PCA fentanyl during the 24 hours after UAE ( P = .006 ) . Numeric rating scale scores for pain ( 5.0±2.4 vs 7.0±2.2 ; P = .026 ) and the need for additional analgesics ( two of 25 vs 17 of 25 ; P<.001 ) were lower in the dexmedetomidine group than in the control group during the first 1 hour after UAE . The incidence and severity of nausea and vomiting during the 24 hours after UAE were lower in the dexmedetomidine group than in the control group ( P < .05 ) . CONCLUSIONS The addition of dexmedetomidine infusion to fentanyl PCA provides better analgesia , fentanyl-sparing effect , and less nausea and vomiting , without significant hemodynamic instability Thirty-four patients scheduled for elective inpatient surgery were r and omized equally to receive either dexmedetomidine ( initial loading dose of 1-&mgr;g/kg over 10 min followed by 0.4 & mgr;g · kg−1 · h−1 for 4 h ) or morphine sulfate ( 0.08 mg/kg ) 30 min before the end of surgery . We determined heart rate ( HR ) , mean arterial blood pressure ( MAP ) , respiratory rate ( RR ) , sedation and analgesia ( visual analog scale ) , and use of additional morphine in the postanesthesia care unit ( PACU ) and up to 24 h after surgery . Groups were similar for patient demographics , ASA physical status , surgical procedure , baseline hemodynamics , and intraoperative use of drugs and fluids . Dexmedetomidine-treated patients had slower HR in the PACU ( by an average of 16 bpm ) , whereas MAP , RR , and level of sedation were similar between groups . During Phase I recovery , dexmedetomidine-treated patients required significantly less morphine to achieve equivalent analgesia ( PACU dexmedetomidine group , 4.5 ± 6.8 mg ; morphine group , 9.2 ± 5.2 mg ) . Sixty minutes into recovery only 6 of 17 dexmedetomidine patients required morphine in contrast to 15 of 17 in the morphine group . The administration of dexmedetomidine before the completion of major inpatient surgical procedures significantly reduced , by 66 % , the early postoperative need for morphine and was associated with a slower HR in the PACU Abstract Smoking is one of the most common addictions in the world . Nicotine inhalation could increase the risk of cardiorespiratory diseases . However , the solution that improved postoperative analgesia for highly nicotine-dependent patients undergoing thoracic surgery has not been specifically addressed . This CONSORT- prospect i ve , r and omized , double-blinded , controlled trial investigated the efficacy of combination of dexmedetomidine and sufentanil for highly nicotine ( Fagerstrom test of nicotine dependence ≥6)-dependent patients after thoracic surgery . One hundred seventy-four male patients who underwent thoracic surgery were screened between February 2014 and November 2014 , and a total of forty-nine were excluded . One hundred thirty-two highly nicotine-dependent male patients who underwent thoracic surgery and received postoperative patient-controlled intravenous analgesia were divided into 3 groups after surgery in this double-blind , r and omized study : sufentanil ( 0.02 & mgr;g/kg/h , Group S ) , sufentanil plus dexmedetomidine ( 0.02 & mgr;g/kg/h each , Group D1 ) , or sufentanil ( 0.02 & mgr;g/kg/h ) plus dexmedetomidine ( 0.04 & mgr;g/kg/h ) ( Group D2 ) . The patient-controlled analgesia ( PCA ) program was programmed to deliver a bolus dose of 2 ml , with background infusion of 2 ml/h and a lockout of 5 min , 4-hour limit of 40 ml , as our retrospective study . The primary outcome measure was the cumulative amount of self-administered sufentanil ; the secondary outcome measures were pain intensity ( numerical rating scale , NRS ) , level of sedation ( LOS ) , Bruggrmann comfort scale ( BCS ) , functional activity score ( FAS ) , and concerning adverse effects . The amount of self-administered sufentanil were lower in group D2 compared with S and D1 groups during the 72 hours after surgery ( P < 0.05 ) , whereas the total dosage and dosage per body weight of sufentanil were significantly lower in D1 group than that of S group only at 4 , 8 , and 16 hours after surgery ( P < 0.05 ) . Compared with S group , the NRS scores at rest at 1 , 4 , and 8 hours after surgery and with coughing at 4 , 8 , 16 , and 24 hours after surgery were significantly lower in D2 group ( P < 0.05 ) . However , compared with D1 group , the NRS scores both at rest and with coughing at 4 and 8 hours after surgery were significantly lower in D2 group ( P < 0.05 ) . The NRS scores both at rest and with coughing show that there were no significant differences between D1 group and S group at each time point after surgery ( P > 0.05 ) . LOS of group D2 was higher than S and D1 groups at 1 hour after surgery ( P < 0.05 ) , BCS of group D2 was higher than S and D1 groups at 4 , 8 , and 16 hours after surgery ( P < 0.05 ) , and FAS of group D2 was higher than S and D1 groups at 48 and 72 hours after surgery ( P < 0.05 ) . The number of rescue analgesia during 72 hours after surgery in D2 group was lower than S and D1 groups ( P < 0.05 ) . There were no significant differences among the 3 groups in terms of baseline clinical characteristics and postoperative adverse effects except for itching ( P > 0.05).Among the tested patient-controlled analgesia options , the addition of dexmedetomidine ( 0.04 & mgr;g/kg/h ) and sufentanil ( 0.02 & mgr;g/kg/h ) showed better analgesic effect and greater patient satisfaction without other clinical ly relevant side effects for highly nicotine-dependent patients during the initial 72 hours after thoracic surgery . Trial Registration : chictr.org ( ChiCTR-TRC-14004191 ) BACKGROUND Perioperative use of dexmedetomidine is associated with reduction in postoperative analgesic requirements . This study examined whether dexmedetomidine added to i.v . patient-controlled analgesia ( PCA ) morphine could improve analgesia while reducing opioid-related side-effects . METHODS In this double-blinded , r and omized , controlled study , 100 women undergoing abdominal total hysterectomy were allocated to receive either morphine 1 mg ml(-1 ) alone ( Group M ) or morphine 1 mg ml(-1 ) plus dexmedetomidine 5 microg ml(-1 ) ( Group D ) for postoperative i.v . PCA , which was programmed to deliver 1 ml per dem and with a 5 min lockout interval and no background infusion . Cumulative PCA requirements , pain intensities , cardiovascular and respiratory variables , and PCA-related adverse events were recorded for 24 h after operation . RESULTS Compared with Group M , patients in Group D required 29 % less morphine during the 0 - 24 h postoperative period and reported significantly lower pain levels from the second postoperative hour onwards and throughout the study . Whereas levels of sedation were similar between the groups at each observational time point , decreases in heart rate and mean blood pressure from presurgery baseline at 1 , 2 , and 4 h after operation were significantly greater in Group D ( by a range of 5 - 7 beats min(-1 ) and 10 - 13 % , respectively ) . The 4 - 24 h incidence of nausea was significantly lower in Group D ( 34 % vs 56.3 % , P<0.05 ) . There was no bradycardia , hypotension , oversedation , or respiratory depression . CONCLUSIONS The addition of dexmedetomidine to i.v . PCA morphine result ed in superior analgesia , significant morphine sparing , less morphine-induced nausea , and was devoid of additional sedation and untoward haemodynamic changes Introduction Only limited information exists on the pharmacokinetics of prolonged ( > 24 hours ) and high-dose dexmedetomidine infusions in critically ill patients . The aim of this study was to characterize the pharmacokinetics of long dexmedetomidine infusions and to assess the dose linearity of high doses . Additionally , we wanted to quantify for the first time in humans the concentrations of H-3 , a practically inactive metabolite of dexmedetomidine . Methods Thirteen intensive care patients with mean age of 57 years and Simplified Acute Physiology Score ( SAPS ) II score of 45 were included in the study . Dexmedetomidine infusion was commenced by using a constant infusion rate for the first 12 hours . After the first 12 hours , the infusion rate of dexmedetomidine was titrated between 0.1 and 2.5 μg/kg/h by using predefined dose levels to maintain sedation in the range of 0 to -3 on the Richmond Agitation-Sedation Scale . Dexmedetomidine was continued as long as required to a maximum of 14 days . Plasma dexmedetomidine and H-3 metabolite concentrations were measured , and pharmacokinetic variables were calculated with st and ard noncompartmental methods . Safety and tolerability were assessed by adverse events , cardiovascular signs , and laboratory tests . Results The following geometric mean values ( coefficient of variation ) were calculated : length of infusion , 92 hours ( 117 % ) ; dexmedetomidine clearance , 39.7 L/h ( 41 % ) ; elimination half-life , 3.7 hours ( 38 % ) ; and volume of distribution during the elimination phase , 223 L ( 35 % ) . Altogether , 116 steady-state concentrations were found in 12 subjects . The geometric mean value for clearance at steady state was 53.1 L/h ( 55 % ) . A statistically significant linear relation ( r2 = 0.95 ; P < 0.001 ) was found between the areas under the dexmedetomidine plasma concentration-time curves and cumulative doses of dexmedetomidine . The elimination half-life of H-3 was 9.1 hours ( 37 % ) . The ratio of AUC0-∞ of H-3 metabolite to that of dexmedetomidine was 1.47 ( 105 % ) , ranging from 0.29 to 4.4 . The ratio was not statistically significantly related to the total dose of dexmedetomidine or the duration of the infusion . Conclusions The results suggest linear pharmacokinetics of dexmedetomidine up to the dose of 2.5 μg/kg/h . Despite the high dose and prolonged infusions , safety findings were as expected for dexmedetomidine and the patient population .Trial Registration Clinical Trials.gov : Abstract Both dexmedetomidine and sufentanil modulate spinal analgesia by different mechanisms , and yet no human studies are available on their combination for analgesia during the first 72 hours after abdominal hysterectomy . This CONSORT- prospect i ve , r and omized , double-blinded , controlled trial sought to evaluate the safety and efficacy of the combination of dexmedetomidine and sufentanil in intravenous patient-controlled analgesia ( PCA ) for 72 hours after abdominal hysterectomy . Ninety women undergoing total abdominal hysterectomy were divided into 3 equal groups that received sufentanil ( Group C ; 0.02 & mgr;g/kg/h ) , sufentanil plus dexmedetomidine ( Group D1 ; 0.02 & mgr;g/kg/h , each ) , or sufentanil ( 0.02 & mgr;g/kg/h
Output:
| DEX had no effect on the incidence of hypotension or bradycardia , which was also confirmed by the TSA .
The GRADE level of evidence was high for postoperative nausea , moderate for pain intensity at rest at 24 hours postoperatively , morphine-equivalent requirement during 0 - 24 hours postoperatively , and postoperative vomiting , pruritus , and bradycardia , and low for postoperative hypotension .
LIMITATIONS The risk of introducing potentially significant heterogeneity exists , and this study did not evaluate the effects of DEX combined with opioids on long-term outcomes including chronic pain and patients ' satisfaction after hospital discharge .
Postoperative PCA strategies with opioid-DEX combinations decreased postoperative pain , opioid requirement , and opioid-related adverse events .
DEX is a useful adjuvant to opioid-based PCA . |
MS213495 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: AIM To evaluate a hypotensive action of long-acting garlic powder tablets allicor in patients with mild or moderate hypertension and to compare allicor effects with those of foreign analog -- kwai garlic tablets . MATERIAL AND METHODS A double-blind , r and omized and placebo-controlled study enrolled 85 patients with mild or moderate hypertension . The patients were divided into 4 groups : group 1 received allicor in a dose 600 mg/day , group 2 - -2400 mg/day , group 3 - -kwai in a dose 900 mg/day , group 4 - -placebo . RESULTS Allicor produced reaction in both systolic and diastolic pressure . An increase of allicor daily dose to 2400 mg does not provide an additional hypotensive effect . Kwai results in only systolic but not diastolic arterial pressure lowering . CONCLUSION Allicor is more effective than kwai in reduction of diastolic blood pressure . It can be recommended as a hypotensive treatment in mild and moderate arterial hypertension This study examined the effects of garlic and fish-oil supplementation ( alone and in combination ) on fasting serum lipids and lipoproteins in hypercholesterolemic subjects . After an initial run-in phase , 50 male subjects with moderate hypercholesterolemia were r and omly assigned for 12 wk to one of four groups : 1 ) 900 mg garlic placebo/d + 12 g oil placebo/d ; 2 ) 900 mg garlic/d + 12 g oil placebo/d ; 3 ) 900 mg garlic placebo/d + 12 g fish oil/d , providing 3.6 g n-3 fatty acids/d ; and 4 ) 900 mg garlic/d + 12 g fish oil/d . In the placebo group , mean serum total cholesterol , low-density-lipoprotein cholesterol ( LDL-C ) , and triacylglycerols were not significantly changed in relation to baseline . Mean group total cholesterol concentrations were significantly lower with garlic+fish oil ( -12.2 % ) and with garlic ( -11.5 % ) after 12 wk but not with fish oil alone . Mean LDL-C concentrations were reduced with garlic+fish oil ( -9.5 % ) and with garlic ( -14.2 % ) but were raised with fish oil ( + 8.5 % ) . Mean triacylglycerol concentrations were reduced with garlic+fish oil ( -34.3 % ) and fish oil alone ( -37.3 % ) . The garlic groups ( with and without fish oil ) had significantly lower ratios of total cholesterol to high-density-lipoprotein cholesterol ( HDL-C ) and LDL-C to HDL-C. In summary , garlic supplementation significantly decreased both total cholesterol and LDL-C whereas fish-oil supplementation significantly decreased triacylglycerol concentrations and increased LDL-C concentrations in hypercholesterolemic men . The combination of garlic and fish oil reversed the moderate fish-oil-induced rise in LDL-C. Coadministration of garlic with fish oil was well-tolerated and had a beneficial effect on serum lipid and lipoprotein concentrations by providing a combined lowering of total cholesterol , LDL-C , and triacylglycerol concentrations as well as the ratios of total cholesterol to HDL-C and LDL-C to A double-blind crossover study comparing the effect of aged garlic extract with a placebo on blood lipids was performed in a group of 41 moderately hypercholesterolemic men [ cholesterol concentrations 5.7 - 7.5 mmol/L ( 220 - 290 mg/dL ) ] . After a 4-wk baseline period , during which the subjects were advised to adhere to a National Cholesterol Education Program Step I diet , they were started on 7.2 g aged garlic extract per day or an equivalent amount of placebo as a dietary supplement for a period of 6 mo , then switched to the other supplement for an additional 4 mo . Blood lipids , blood counts , thyroid and liver function measures , body weight , and blood pressure were followed over the entire study period . The major findings were a maximal reduction in total serum cholesterol of 6.1 % or 7.0 % in comparison with the average concentration during the placebo administration or baseline evaluation period , respectively . Low-density-lipoprotein cholesterol was also decreased by aged garlic extract , 4 % when compared with average baseline values and 4.6 % in comparison with placebo period concentrations . In addition , there was a 5.5 % decrease in systolic blood pressure and a modest reduction of diastolic blood pressure in response to aged garlic extract . We conclude that dietary supplementation with aged garlic extract has beneficial effects on the lipid profile and blood pressure of moderately hypercholesterolemic subjects The efficacy and tolerance of a garlic preparation ( Sapec , Kwai ) was investigated in a r and omized double-blind study vs. bezafibrate . This multi-centre study was conducted in 5 general medical practice s and involved 98 patients with primary hyperlipoproteinaemia . The daily doses of the active substances were 900 mg of garlic powder ( st and ardized as to 1.3 % alliin ) and 600 mg of bezafibrate , respectively . The pre-phase with placebo lasted 6 weeks , the treatment period covered 12 weeks . All patients were advised to observe a low-fat " step-1 diet " for the duration of the study . The 98 case report forms allowed the statistical evaluation of total cholesterol , HDL cholesterol and triglyceride levels for 94 patients , and of LDL cholesterol values for 92 patients . In the course of the treatment both study medications caused a statistically highly significant reduction in total cholesterol , in LDL cholesterol and triglycerides , and an increase in HDL cholesterol . However , there was no significant difference in the efficacies of both medication groups . Side effects were mentioned by 5 patients each in both treatment groups , none of which led to the withdrawal of the patients . Concerning the garlic preparation , there was no correlation between the perception of garlic odour and the influence on the cholesterol level BACKGROUND Prehypertension is considered a precursor of stage 1 hypertension and a predictor of excessive cardiovascular risk . We investigated whether pharmacologic treatment of prehypertension prevents or postpones stage 1 hypertension . METHODS Participants with repeated measurements of systolic pressure of 130 to 139 mm Hg and diastolic pressure of 89 mm Hg or lower , or systolic pressure of 139 mm Hg or lower and diastolic pressure of 85 to 89 mm Hg , were r and omly assigned to receive two years of c and esartan ( Atac and , AstraZeneca ) or placebo , followed by two years of placebo for all . When a participant reached the study end point of stage 1 hypertension , treatment with antihypertensive agents was initiated . Both the c and esartan group and the placebo group were instructed to make changes in lifestyle to reduce blood pressure throughout the trial . RESULTS A total of 409 participants were r and omly assigned to c and esartan , and 400 to placebo . Data on 772 participants ( 391 in the c and esartan group and 381 in the placebo group ; mean age , 48.5 years ; 59.6 percent men ) were available for analysis . During the first two years , hypertension developed in 154 participants in the placebo group and 53 of those in the c and esartan group ( relative risk reduction , 66.3 percent ; P<0.001 ) . After four years , hypertension had developed in 240 participants in the placebo group and 208 of those in the c and esartan group ( relative risk reduction , 15.6 percent ; P<0.007 ) . Serious adverse events occurred in 3.5 percent of the participants assigned to c and esartan and 5.9 percent of those receiving placebo . CONCLUSIONS Over a period of four years , stage 1 hypertension developed in nearly two thirds of patients with untreated prehypertension ( the placebo group ) . Treatment of prehypertension with c and esartan appeared to be well tolerated and reduced the risk of incident hypertension during the study period . Thus , treatment of prehypertension appears to be feasible . ( Clinical Trials.gov number , NCT00227318 . ) OBJECTIVE To determine whether garlic extract therapy is efficacious and safe in children with hypercholesterolemia . DESIGN R and omized , double-blind , placebo-controlled clinical trial . SETTING Specialized pediatric lipid disorders ambulatory clinic . PARTICIPANTS Thirty pediatric patients , aged 8 to 18 years , who had familial hyperlipidemia and a minimum fasting total cholesterol level greater than 4.8 mmol/L ( > 185 mg/dL ) . INTERVENTION An 8-week course of a commercially available garlic extract ( Kwai [ Lichtwer Pharma , Berlin , Germany ] , 300 mg , 3 times a day ) or an identical placebo . MAIN OUTCOME MEASURES Absolute and relative changes in fasting lipid profile parameters . RESULTS The groups were equivalent at baseline and compliance was similar in the 2 groups ( P = .45 ) . There was no significant relative attributable effect of garlic extract on fasting total cholesterol ( + 0.6 % [ 95 % confidence interval , -5.8 % to + 6.9%1 ) or low-density lipoprotein cholesterol ( -0.5 % [ 95 % confidence interval , -8.7 % to + 7.6 % ] ) . The lower limits of the confidence intervals did not include -10 % , the minimum relative attributable effect believed to be clinical ly important . Likewise , no significant effect was seen on the levels of high-density lipoprotein , triglycerides , apolipoprotein B-100 , lipoprotein ( a ) , fibrinogen , homocysteine , or blood pressure . There was a small effect on apolipoprotein A-I ( + 10.0 % [ 95 % confidence interval , + 1.2 % to + 16.5 % ] P=.03 ) . There were no differences in adverse effects between groups . CONCLUSION Garlic extract therapy has no significant effect on cardiovascular risk factors in pediatric patients with familial hyperlipidemia PURPOSE To assess the effects of st and ardized garlic powder tablets on serum lipids and lipoproteins , glucose , and blood pressure . SUBJECTS AND METHODS Forty-two healthy adults ( 19 men , 23 women ) , mean age of 52 + /- 12 years , with a serum total cholesterol ( TC ) level of greater than or equal to 220 mg/dL received , in a r and omized , double-blind fashion , either 300 mg three times a day of st and ardized garlic powder in tablet form or placebo . Diets and physical activity were unchanged . This study was conducted in an outpatient , clinical research unit . RESULTS The baseline serum TC level of 262 + /- 34 mg/dL was reduced to 247 + /- 40 mg/dL ( p < 0.01 ) after 12 weeks of st and ard garlic treatment . Corresponding values for placebo were 276 + /- 34 mg/dL before and 274 + /- 29 mg/dL after placebo treatment . Low-density lipoprotein cholesterol ( LDL-C ) was reduced by 11 % by garlic treatment and 3 % by placebo ( p < 0.05 ) . There were no significant changes in high-density lipoprotein cholesterol , triglycerides , serum glucose , blood pressure , and other monitored parameters . CONCLUSIONS Treatment with st and ardized garlic 900 mg/d produced a significantly greater reduction in serum TC and LDL-C than placebo . The garlic formulation was well tolerated without any odor problems The ingestion of garlic has been reported to have many cardiovascular effects , including a reduction in plasma cholesterol concentration and the susceptibility of LDL to oxidation . A double-blind , placebo-controlled , r and omised crossover study was conducted in subjects with mild to moderate hypercholesterolaemia who were subject to strict dietary supervision and assessment . After a baseline dietary period of 28 days , subjects took Kwai garlic powder tablets 300 mg three times daily or matching placebo for 12 weeks , followed by 28 days washout , followed by a 12 weeks crossover on the alternative preparation . In the analysis hypercholesterolaemia was defined as those subjects in the range 5.5 - 8.05 mmol/l . Three subjects were withdrawn , one allocated to garlic and complaining of garlic body odour , one using placebo having intercurrent health problems , and one with a baseline cholesterol below 5.5 mmol/l , yielding analysable results in 28 subjects . Comparing the period on garlic with that on placebo , there were no significant differences in plasma cholesterol , LDL cholesterol , HDL cholesterol , plasma triglycerides , lipoprotein(a ) concentrations , or blood pressure . Mean LDL cholesterol concentration was 4.64 + /- 0.52 mmol/l
Output:
| Conclusion Our meta- analysis suggests that garlic preparations are superior to placebo in reducing blood pressure in individuals with hypertension |
MS213496 | ***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 compare short- and long-term clinical outcomes after conventional transarterial chemoembolization and drug-eluting bead ( DEB ) transarterial chemoembolization in hepatocellular carcinoma ( HCC ) . MATERIAL S AND METHODS Patients with unresectable HCC unsuitable for ablative therapies were r and omly assigned to undergo conventional or DEB chemoembolization . The primary endpoints of the study were safety , toxicity , and tumor response at 1 month . Secondary endpoints were number of repeated chemoembolization cycles , time to recurrence and local recurrence , time to radiologic progression , and survival . RESULTS In total , 67 patients ( mean age , 70 y ± 7.7 ) were evaluated . Mean follow-up was 816 days ± 361 . Two periprocedural major complications occurred ( 2.9 % ) that were treated by medical therapy without the need for other interventions . A significant increase in alanine aminotransferase levels 24 hours after treatment was reported , which was significantly greater after conventional chemoembolization ( n = 34 ) than after DEB chemoembolization ( n = 33 ; preprocedure , 60 IU ± 44 vs 74 IU ± 62 , respectively ; at 24 h , 216 IU ± 201 vs 101 IU ± 89 , respectively ; P = 0.007 ) . No other differences were observed in liver toxicity between groups . At 1 month , complete and partial tumor response rates were 70.6 % and 29.4 % , respectively , in the conventional chemoembolization group and 51.5 % and 48.5 % , respectively , in the DEB chemoembolization group . No differences were observed between groups in time to recurrence and local recurrence , radiologic progression , and survival . CONCLUSIONS Conventional chemoembolization and DEB chemoembolization have a limited impact on liver function on short- and long-term follow-up and are associated with favorable clinical outcomes Transcatheter arterial chemoembolization ( TACE ) offers a survival benefit to patients with intermediate hepatocellular carcinoma ( HCC ) . A widely accepted TACE regimen includes administration of doxorubicin-oil emulsion followed by gelatine sponge — conventional TACE . Recently , a drug-eluting bead ( DC Bead ® ) has been developed to enhance tumor drug delivery and reduce systemic availability . This r and omized trial compares conventional TACE ( cTACE ) with TACE with DC Bead for the treatment of cirrhotic patients with HCC . Two hundred twelve patients with Child-Pugh A/B cirrhosis and large and /or multinodular , unresectable , N0 , M0 HCCs were r and omized to receive TACE with DC Bead loaded with doxorubicin or cTACE with doxorubicin . R and omization was stratified according to Child-Pugh status ( A/B ) , performance status ( ECOG 0/1 ) , bilobar disease ( yes/no ) , and prior curative treatment ( yes/no ) . The primary endpoint was tumor response ( EASL ) at 6 months following independent , blinded review of MRI studies . The drug-eluting bead group showed higher rates of complete response , objective response , and disease control compared with the cTACE group ( 27 % vs. 22 % , 52 % vs. 44 % , and 63 % vs. 52 % , respectively ) . The hypothesis of superiority was not met ( one-sided P = 0.11 ) . However , patients with Child-Pugh B , ECOG 1 , bilobar disease , and recurrent disease showed a significant increase in objective response ( P = 0.038 ) compared to cTACE . DC Bead was associated with improved tolerability , with a significant reduction in serious liver toxicity ( P < 0.001 ) and a significantly lower rate of doxorubicin-related side effects ( P = 0.0001 ) . TACE with DC Bead and doxorubicin is safe and effective in the treatment of HCC and offers a benefit to patients with more advanced disease Background To compare the overall survival of patients with hepatocellular carcinoma ( HCC ) who were treated with lipiodol-based conventional transarterial chemoembolization ( cTACE ) with that of patients treated with drug-eluting bead transarterial chemoembolization ( DEB-TACE ) . Methods By an electronic search of our radiology information system , we identified 674 patients that received TACE between November 2002 and July 2013 . A total of 520 patients received cTACE , and 154 received DEB-TACE . In total , 424 patients were excluded for the following reasons : tumor type other than HCC ( n = 91 ) , liver transplantation after TACE ( n = 119 ) , lack of histological grading ( n = 58 ) , incomplete laboratory values ( n = 15 ) , other reasons ( e.g. , previous systemic chemotherapy ) ( n = 114 ) , or were lost to follow-up ( n = 27 ) . Therefore , 250 patients were finally included for comparative analysis ( n = 174 cTACE ; n = 76 DEB-TACE ) . Results There were no significant differences between the two groups regarding sex , overall status ( Barcelona Clinic Liver Cancer classification ) , liver function ( Child-Pugh ) , portal invasion , tumor load , or tumor grading ( all p > 0.05 ) . The mean number of treatment sessions was 4 ± 3.1 in the cTACE group versus 2.9 ± 1.8 in the DEB-TACE group ( p = 0.01 ) . Median survival was 409 days ( 95 % CI : 321–488 days ) in the cTACE group , compared with 369 days ( 95 % CI : 310–589 days ) in the DEB-TACE group ( p = 0.76 ) . In the subgroup of Child A patients , the survival was 602 days ( 484–792 days ) for cTACE versus 627 days ( 364–788 days ) for DEB-TACE ( p = 0.39 ) . In Child B/C patients , the survival was considerably lower : 223 days ( 165–315 days ) for cTACE versus 226 days ( 114–335 days ) for DEB-TACE ( p = 0.53 ) . Conclusion The present study showed no significant difference in overall survival between cTACE and DEB-TACE in patients with HCC . However , the significantly lower number of treatments needed in the DEB-TACE group makes it a more appealing treatment option than cTACE for appropriately selected patients with unresectable HCC Background : Transcatheter arterial chemoembolization ( TACE ) is the st and ard treatment in selected patients with unresectable hepatocellular carcinoma ( HCC ) . Drug-eluting particles are developed to reduce side effects and improve efficacy . We present safety data of a prospect i ve r and omized phase II study with doxorubicin-eluting superabsorbent polymer ( SAP ) microspheres . Material and Methods : We prospect ively included 30 HCC patients with different Barcelona Clinic Liver Cancer ( BCLC ) stages ( A = 3 , B = 19 , C = 8) and r and omly assigned them to receive conventional TACE ( n = 14 ) ( control group ) or doxorubicin-eluting SAP microspheres ( n = 16 ) . The doxorubicin plasma level was assessed at different time points , biochemical analysis was performed , and side effects were reported following the Common Toxicity Criteria . Tumor response was assessed at 6 weeks according to the modified Response Evaluation Criteria in Solid Tumors ( RECIST ) criteria . Results : There was a significantly lower plasma peak concentration ( Cmax ) of doxorubicin and smaller area under the curve ( AUC ) with SAP microspheres ( mean Cmax 495 ± 293.9 ng/ml , mean AUC 69.7 ± 26.9 ng/ml min ) compared to controls ( mean Cmax 1,928 ± 560.8 ng/ml , mean AUC 165 ± 32.3 ng/ml/min ; both p < 0.001 ) . Furthermore , there were less grade 3 and no grade 4 adverse events in the SAP microsphere group . Tumor response was comparable between the groups . Conclusions : TACE with SAP microspheres leads to low plasma levels of the cytotoxic drug and therefore minimizes toxicity compared to conventional TACE Background : Transcatheter arterial chemoembolisation ( TACE ) is the treatment of choice for intermediate stage hepatocellular carcinoma ( HCC ) . Doxorubicin-loaded drug-eluting beads (DEB)-TACE is expected to improve the performance of conventional TACE ( cTACE ) . The aim of this study was to compare DEB-TACE with cTACE in terms of time-to-tumour progression ( TTP ) , adverse events ( AEs ) , and 2-year survival . Methods : Patients were r and omised one-to-one to undergo cTACE or DEB-TACE and followed-up for at least 2 years or until death . Transcatheter arterial chemoembolisation was repeated ‘ on-dem and ’ . Results : We enrolled 177 patients : 89 underwent DEB-TACE and 88 cTACE . The median number of procedures was 2 in each arm , and the in-hospital stay was 3 and 4 days , respectively ( P=0.323 ) . No differences were found in local and overall tumour response . The median TTP was 9 months in both arms . The AE incidence and severity did not differ between the arms , except for post-procedural pain , more frequent and severe after cTACE ( P<0.001 ) . The 1- and 2-year survival rates were 86.2 % and 56.8 % after DEB-TACE and 83.5 % and 55.4 % after cTACE ( P=0.949 ) . Eastern Cooperative Oncology Group ( ECOG ) , serum albumin , and tumour number independently predicted survival ( P<0.05 ) . Conclusions : The DEB-TACE and the cTACE are equally effective and safe , with the only advantage of DEB-TACE being less post-procedural abdominal pain Objective Lipiodol transcatheter arterial chemoembolization ( TACE ) is widely used to treat hepatocellular carcinoma ( HCC ) . Recently , a drug-eluting bead ( DEB ) has been developed to enhance drug delivery to the tumor and reduce its systemic availability . The purpose of this study was to compare the efficacy and safety of intra-arterial injection of DEB loaded with doxorubicin versus conventional , Lipiodol-based TACE regimens in Asian patients with HCC . Methods The study was design ed as a case – control , single-institution clinical trial . Twenty patients with HCC who received DEB loaded with 50 mg doxorubicin ( ‘ cases ’ ) were matched with 20 patients who had undergone conventional TACE ( ‘ controls ’ ) . The primary efficacy endpoint was tumor response at 1 month according to modified Response Evaluation Criteria in Solid Tumors . The primary safety endpoint was liver toxicity . Results The rate of objective response by modified Response Evaluation Criteria in Solid Tumors was 85 % ( 17 of 20 patients ) in the DEB arm versus 30 % ( six of 20 patients ) in the conventional TACE arm ( P=0.001 ) . Subgroup analyses conducted in patients with large ( > 5 cm ) or multinodular tumor confirmed significantly higher objective response rates in patients receiving DEB as compared with those treated with conventional TACE ( P=0.003 and P=0.005 , respectively ) . At the dose of 50 mg doxorubicin , there was no statistically significant difference in liver toxicity between DEB and conventional TACE ( P>0.05 ) . Conclusion In Asian patients with HCC , transcatheter treatment with DEB loaded with doxorubicin offers a distinct advantage in objective tumor response rate as compared with conventional , Lipiodol-based TACE regimens Chemoembolization with lipiodol ( TACE ) improves survival of selected patients with unresectable hepatocellular carcinoma ( HCC ) , but results in substantial toxicity . To improve treatment tolerance , we conducted this phase II study using doxorubicin-loaded beads ( DC Beads ® ) delivered by selective transcatheter arterial chemoembolization ( DEB-TACE ) . We compared the results with those obtained with TACE in our historical controls . Thirty-five patients were recruited with diagnoses of HCC . Patients received DEB-TACE with doxorubicin loaded on DC Beads . Computed tomography of the upper abdomen was performed one month after DEB-TACE . Historical controls were a group of 70 patients with matched characteristics treated with TACE . After a median follow-up of 14.1 months ( range , 6 - 36 months ) , 22 patients ( 63 % ) had an objective response . There was a statistically significant decrease in liver enzymes ( p<0.001 ) , lactate dehydrogenase , ( p<0.001 ) in DEB-TACE-treated patients compared to TACE-treated patients . DEB-TACE with doxorubicin-loaded DC Beads , a safe and reliable treatment for HCC , leads to decreased toxicity compared to TACE
Output:
| CONCLUSION Compared with cTACE , DEB-TACE therapy significantly improved 1- , 2- , and 3-year OS rates and the 1- and 2-year RFS rates |
MS213497 | ***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: RTS , S/AS02 is a recombinant protein malaria vaccine that contains a large portion of the C-terminal of the circumsporozoite protein ( CSP ) sequence of the NF54 isolate of Plasmodium falciparum fused to the hepatitis B virus surface antigen . It has been shown to induce significant protection to challenge infection with a homologous parasite strain in American volunteers . In a recently completed trial in semi-immune Gambian adults , vaccine efficacy against natural infection was 34 % ( 95 % confidence interval = 8 - 53 % , P = 0.014 ) during the malaria season following vaccination . Breakthrough P. falciparum parasites sample d from vaccinated subjects and from controls were genotyped at two polymorphic regions of the csp gene encoding T cell epitopes ( csp-th2r and csp-th3r ) to determine if the vaccine conferred a strain-specific effect . The overall distribution of csp allelic variants was similar in infections occurring in vaccine and control groups . Also , the mean number of genotypes per infection in the RTS , S/AS02 group was not reduced compared with the controls Background Many malaria vaccines are currently in development , although very few have been evaluated for efficacy in the field . Plasmodium falciparum multiple epitope (ME)– thrombospondin-related adhesion protein ( TRAP ) c and i date vaccines are design ed to potently induce effector T cells and so are a departure from earlier malaria vaccines evaluated in the field in terms of their mechanism of action . ME-TRAP vaccines encode a polyepitope string and the TRAP sporozoite antigen . Two vaccine vectors encoding ME-TRAP , plasmid DNA and modified vaccinia virus Ankara ( MVA ) , when used sequentially in a prime-boost immunisation regime , induce high frequencies of effector T cells and partial protection , manifest as delay in time to parasitaemia , in a clinical challenge model . Methods and Findings A total of 372 Gambian men aged 15–45 y were r and omised to receive either DNA ME-TRAP followed by MVA ME-TRAP or rabies vaccine ( control ) . Of these men , 296 received three doses of vaccine timed to coincide with the beginning of the transmission season ( 141 in the DNA/MVA group and 155 in the rabies group ) and were followed up . Volunteers were given sulphadoxine/pyrimethamine 2 wk before the final vaccination . Blood smears were collected weekly for 11 wk and whenever a volunteer developed symptoms compatible with malaria during the transmission season . The primary endpoint was time to first infection with asexual P. falciparum . Analysis was per protocol . DNA ME-TRAP and MVA ME-TRAP were safe and well-tolerated . Effector T cell responses to a non-vaccine strain of TRAP were 50-fold higher postvaccination in the malaria vaccine group than in the rabies vaccine group . Vaccine efficacy , adjusted for confounding factors , was 10.3 % ( 95 % confidence interval , −22 % to + 34 % ; p = 0.49 ) . Incidence of malaria infection decreased with increasing age and was associated with ethnicity . Conclusions DNA/MVA heterologous prime-boost vaccination is safe and highly immunogenic for effector T cell induction in a malaria-endemic area . But despite having produced a substantial reduction in liver-stage parasites in challenge studies of non-immune volunteers , this first generation T cell – inducing vaccine was ineffective at reducing the natural infection rate in semi-immune African adults In animals , effective immune responses against malignancies and against several infectious pathogens , including malaria , are mediated by T cells . Here we show that a heterologous prime-boost vaccination regime of DNA either intramuscularly or epidermally , followed by intradermal recombinant modified vaccinia virus Ankara ( MVA ) , induces high frequencies of interferon (IFN)-γ-secreting , antigen-specific T-cell responses in humans to a pre-erythrocytic malaria antigen , thrombospondin-related adhesion protein ( TRAP ) . These responses are five- to tenfold higher than the T-cell responses induced by the DNA vaccine or recombinant MVA vaccine alone , and produce partial protection manifest as delayed parasitemia after sporozoite challenge with a different strain of Plasmodium falciparum . Such heterologous prime-boost immunization approaches may provide a basis for preventative and therapeutic vaccination in humans ICC-1132 , a recombinant virus-like particle comprising of a modified hepatitis B core protein with a B cell ( NANP ) and two T cell epitopes of Plasmodium falciparum circumsporozoite protein ( CSP ) , was administered i.m . as a single 50 microg dose in Seppic ISA 720 to 11 volunteers . Local reactogenicity and systemic side effects were acceptable with the predominant finding being mild pain at the injection site . This regimen induced anti-NANP antibodies in 10/11 and modest T cell responses . There was no evidence of protection from experimental challenge with P. falciparum sporozoites . Other formulations and /or multi-dose regimens will be required to enhance the immunogenicity and efficacy of ICC-1132 After initial successful evaluation of the circumsporozoite-based vaccine RTS , S/SBAS2 , developed by SmithKline Beecham Biologicals with the Walter Reed Army Institute of Research , protective efficacy of several regimens against Plasmodium falciparum challenge was determined . A controlled phase 1/2a study evaluated 1 or 2 st and ard doses of RTS , S/SBAS2 in 2 groups whose members received open-label therapy and 3 immunizations in blinded groups who received st and ard , one-half , or one-fifth doses . RTS , S/SBAS2 was safe and immunogenic in all groups . Of the 41 vaccinees and 23 control subjects who underwent sporozoite challenge , malaria developed in 7 of 10 who received 1 dose , in 7 of 14 who received 2 doses , in 3 of 6 who received 3 st and ard doses , in 3 of 7 who received 3 one-half doses , in 3 of 4 who received 3 one-fifth doses , and in 22 of 23 control subjects . Overall protective efficacy of RTS , S/SBAS2 was 41 % ( 95 % confidence interval , 22%-56 % ; P=.0006 ) . This and previous studies have shown that 2 or 3 doses of RTS , S/SBAS2 protect against challenge with P. falciparum sporozoites BACKGROUND Development of an effective malaria vaccine could greatly contribute to disease control . RTS , S/AS02A is a pre-erythrocytic vaccine c and i date based on Plasmodium falciparum circumsporozoite surface antigen . We aim ed to assess vaccine efficacy , immunogenicity , and safety in young African children . METHODS We did a double-blind , phase IIb , r and omised controlled trial in Mozambique in 2022 children aged 1 - 4 years . The study included two cohorts of children living in two separate areas which underwent different follow-up schemes . Participants were r and omly allocated three doses of either RTS , S/AS02A c and i date malaria vaccine or control vaccines . The primary endpoint , determined in cohort 1 ( n=1605 ) , was time to first clinical episode of P falciparum malaria ( axillary temperature > or = 37.5 degrees C and P falciparum asexual parasitaemia > 2500 per microL ) over a 6-month surveillance period . Efficacy for prevention of new infections was determined in cohort 2 ( n=417 ) . Analysis was per protocol . FINDINGS 115 children in cohort 1 and 50 in cohort 2 did not receive all three doses and were excluded from the per- protocol analysis . Vaccine efficacy for the first clinical episodes was 29.9 % ( 95 % CI 11.0 - 44.8 ; p=0.004 ) . At the end of the 6-month observation period , prevalence of P falciparum infection was 37 % lower in the RTS , S/AS02A group compared with the control group ( 11.9 % vs 18.9 % ; p=0.0003 ) . Vaccine efficacy for severe malaria was 57.7 % ( 95 % CI 16.2 - 80.6 ; p=0.019 ) . In cohort 2 , vaccine efficacy for extending time to first infection was 45.0 % ( 31.4 - 55.9 ; p<0.0001 ) . INTERPRETATION The RTS , S/AS02A vaccine was safe , well tolerated , and immunogenic . Our results show development of an effective vaccine against malaria is feasible A multiple antigen peptide ( MAP ) malaria vaccine containing minimal Plasmodium falciparum circumsporozoite protein repeat epitopes was assessed for safety and immunogenicity in volunteers of known class II genotypes . The MAP/alum/QS-21 vaccine formulation elicited high levels of parasite-specific antibodies in 10 of 12 volunteers expressing DQB1 * 0603 , DRB1 * 0401 , or DRB1 * 1101 class II molecules . In contrast , volunteers of other HLA genotypes were low responders or nonresponders . A second study of 7 volunteers confirmed the correlation of class II genotype and high responder phenotype . This is the first demonstration in humans that a peptide vaccine containing minimal T and B cell epitopes composed of only 5 amino acids ( N , A , V , D , and P ) can elicit antibody titers comparable to multiple exposures to irradiated P. falciparum-infected mosquitoes . Moreover , the high-responder phenotypes were predicted by analysis of peptide/HLA interactions in vitro , thus facilitating the rational design of epitope-based peptide vaccines for malaria , as well as for other pathogens This open-labeled phase I study provides the first demonstration of the immunogenicity of a precisely defined synthetic polyoxime malaria vaccine in volunteers of diverse HLA types . The polyoxime , design ated (T1BT*)4-P3C , was constructed by chemoselective ligation , via oxime bonds , of a tetrabranched core with a peptide module containing B cell epitopes and a universal T cell epitope of the Plasmodium falciparum circumsporozoite protein . The triepitope polyoxime malaria vaccine was immunogenic in the absence of any exogenous adjuvant , using instead a core modified with the lipopeptide P3C as an endogenous adjuvant . This totally synthetic vaccine formulation can be characterized by mass spectroscopy , thus enabling the reproducible production of precisely defined vaccines for human use . The majority of the polyoxime-immunized volunteers ( 7/10 ) developed high levels of anti-repeat Abs that reacted with the native circumsporozoite on P. falciparum sporozoites . In addition , these seven volunteers all developed T cells specific for the universal epitope , termed T * , which was originally defined using CD4 + T cells from protected volunteers immunized with irradiated P. falciparum sporozoites . The excellent correlation of T*-specific cellular responses with high anti-repeat Ab titers suggests that the T * epitope functioned as a universal Th cell epitope , as predicted by previous peptide/HLA binding assays and by immunogenicity studies in mice of diverse H-2 haplotypes . The current phase I trial suggests that polyoximes may prove useful for the development of highly immunogenic , multicomponent synthetic vaccines for malaria , as well as for other pathogens A recombinant DNA Plasmodium vivax sporozoite vaccine containing the repeating region of the Salvador I strain circumsporozoite ( CS ) protein was produced in Escherichia coli . This vaccine was tested in 13 naive volunteers at doses of 10 - 1,000 micrograms . No serious adverse reactions were noted . None of 4 volunteers receiving the 10 micrograms dose developed antibodies measurable by ELISA . Six of 9 volunteers in the other dose groups developed measurable antibodies : 5 of 5 volunteers receiving 100 micrograms and 1 of 4 receiving 1,000 micrograms . Antibody responses measured by immunofluorescence assays paralleled those seen by ELISA . None of the volunteers developed antisera that inhibited sporozoite invasion of human hepatoma cells in vitro . Lack of a classical anamnestic response and lack of a typical dose response to increasing amounts of antigen suggests the possible presence of an immunosuppressive epitope in the repetitive region of the CS protein BACKGROUND The c and i date vaccines against malaria are poorly immunogenic and thus have been ineffective in preventing infection . We developed a vaccine based on the circumsporozoite protein of Plasmodium falciparum that incorporates adjuvants selected to enhance the immune response . METHODS The antigen consists of a hybrid in which the circumsporozoite protein fused to hepatitis B surface antigen ( HBsAg ) is expressed together with unfused H
Output:
| No severe adverse events were judged to be related to RTS , S vaccine , although the frequencies of injection site pain , swelling , arm motion limitation , headache , and malaise were increased in the vaccine groups .
RTS , S vaccine was effective in preventing a significant number of clinical malaria episodes , including good protection against severe malaria in children for 18 months .
No severe adverse events were attributable to the vaccine . |
MS213498 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE This r and omized group experiment compared the efficacy of 2 communication interventions ( Responsive Education and Prelinguistic Milieu Teaching [ RPMT ] and the Picture Exchange Communication System [ PECS ] ) on spoken communication in 36 preschoolers with autism spectrum disorders ( ASD ) . METHOD Each treatment was delivered to children for a maximum total of 24 hr over a 6-month period . Spoken communication was assessed in a rigorous test of generalization at pretreatment , posttreatment , and 6-month follow-up periods . RESULTS PECS was more successful than RPMT in increasing the number of nonimitative spoken communication acts and the number of different nonimitative words used at the posttreatment period . Considering growth over all 3 measurement periods , an exploratory analysis showed that growth rate of the number of different nonimitative words was faster in the PECS group than in the RPMT group for children who began treatment with relatively high object exploration . In contrast , analogous slopes were steeper in the RPMT group than in the PECS group for children who began treatment with relatively low object exploration The context for this work was an evaluation study [ Carr , D. , & Felce , J. A. ( in press ) ] of the early phases of the Picture Exchange Communication System ( PECS ) [ Frost , L. A. , & Bondy , A. S. ( 1994 ) . The picture exchange communication system training manual . Cherry Hill , NJ : Pyramid Educational Consultants , Inc. ; Frost , L. A. , & Bondy , A. S. ( 2004 ) . The picture exchange communication system training manual , 2nd edn . Newark , DE : Pyramid Educational Consultants , Inc. ] . This paper reports that five of 24 children who received 15 h of PECS teaching towards Phase III over a period of 4–5 weeks , showed concomitant increases in speech production , either in initiating communication with staff or in responding , or both . No children in the PECS group demonstrated a decrease in spoken words after receiving PECS teaching . In the control group , only one of 17 children demonstrated a minimal increase and four of 17 children demonstrated a decrease in use of spoken words after a similar period without PECS teaching The study investigated the impact of mastery of the Picture Exchange Communication System ( PECS ) to Phase III , on the communications of children with autism . Children aged between 3 and 7 years , formed a PECS intervention group and a non-intervention control group . The intervention group received 15 h of PECS teaching over 5 weeks . Three 2-h classroom observations recorded communications between the children and their teachers . These occurred : 6 weeks before teaching ; during the week immediately prior to teaching ; during the week immediately following teaching . For the control group , two 2-h observations were separated by a 5-week interval without PECS teaching . Communicative initiations and dyadic interactions increased significantly between the children and teachers in the PECS group but not for the control group OBJECTIVE To assess the effectiveness of expert training and consultancy for teachers of children with autism spectrum disorder in the use of the Picture Exchange Communication System ( PECS ) . METHOD DESIGN Group r and omised , controlled trial ( 3 groups : immediate treatment , delayed treatment , no treatment ) . PARTICIPANTS 84 elementary school children , mean age 6.8 years . TREATMENT A 2-day PECS workshop for teachers plus 6 half-day , school-based training sessions with expert consultants over 5 months . OUTCOME MEASURES Rates of : communicative initiations , use of PECS , and speech in the classroom ; Autism Diagnostic Observation Schedule-Generic ( ADOS-G ) domain scores for Communication and Reciprocal Social Interaction ; scores on formal language tests . RESULTS Controlling for baseline age , developmental quotient ( DQ ) and language ; rates of initiations and PECS usage increased significantly immediately post-treatment ( Odds Ratio ( OR ) of being in a higher ordinal rate category 2.72 , 95 % confidence interval 1.22 - 6.09 , p < .05 and OR 3.90 ( 95%CI 1.75 - 8.68 ) , p < .001 , respectively ) . There were no increases in frequency of speech , or improvements in ADOS-G ratings or language test scores . CONCLUSIONS The results indicate modest effectiveness of PECS teacher training/consultancy . Rates of pupils ' initiations and use of symbols in the classroom increased , although there was no evidence of improvement in other areas of communication . TREATMENT effects were not maintained once active intervention ceased The purpose of this study was to determine ( 1 ) whether comprehension , production , and spontaneous use of language are greater following language training by sign-alone , speech-alone , simultaneous communication , or alternating between speech and sign ; ( 2 ) whether high- and low-verbal imitators benefit from the same mode of treatment ; and ( 3 ) whether retention of the language skills differs among the four training conditions . Subjects were 60 moderate to severe autistic children r and omly assigned to one of four treatment conditions . Subjects were divided into high- and low-verbal imitators based on verbal imitation performances . The results indicated that the high-verbal imitators did equally well in all four treatment conditions , while the low-verbal imitators did poorest in the speech-alone condition . The high-verbal imitators performed better than did the low-verbal imitators in all of the treatment conditions . Words or signs learned were retained for three months after treatment regardless of the treatment condition or level of imitative ability . The results were discussed in terms of the efficacy of using sign language with autistic children This study was carried out to test the main and interaction effects of training condition and pretreatment-elicited verbal imitation ability when predicting spoken language use during language training of 60 minimally verbal autistic children . Subjects were r and omly assigned to Speech Alone , Sign Alone , Simultaneous Presentation of Sign and Speech , and Alternating Presentation of Sign and Speech training conditions . Speech Alone , Simultaneous Presentation , and Alternating Presentation condition facilitated more child-initiated speech during treatment than did the Sign Alone condition . Regardless of training condition , pretreatment verbal imitation ability positively predicted the size of child-initiated spoken vocabulary observed during training . Exploratory analyses indicated that , in addition to verbal imitation , pretreatment age and IQ may also predict spoken language developed during training
Output:
| Results indicated that AAC interventions do not impede speech production .
In fact , most studies reported an increase in speech production .
However , in-depth analyses revealed that the gains were rather modest . |
MS213499 | ***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 increasing number of palliative care patients necessitates a simple , reliable instrument to routinely measure outcomes among hospice patients . We tested the utility of the Brief Hospice Inventory ( BHI ) to assess outcomes of hospice patients and estimations of patients ' outcomes by nurse caregivers . In a prospect i ve study , 145 home-based hospice patients were enrolled in the study from VistaCare Hospice . During the first week of admission , patients and nurse caregivers completed the BHI , which assessed patients ' symptoms , satisfaction with care , and quality of life . Factor analysis supported a two-factor structure for the BHI for patients and caregivers , including a symptom subscale and quality of life subscale . Patients with severe symptoms showed improvement on the symptom subscale , but not the quality of life subscale , during the first 2 weeks after admission . The BHI shows utility in measuring hospice patients ' symptom severity and quality of life over time CONTEXT A clear underst and ing of what patients , families , and health care practitioners view as important at the end of life is integral to the success of improving care of dying patients . Empirical evidence defining such factors , however , is lacking . OBJECTIVE To determine the factors considered important at the end of life by patients , their families , physicians , and other care providers . DESIGN AND SETTING Cross-sectional , stratified r and om national survey conducted in March-August 1999 . PARTICIPANTS Seriously ill patients ( n = 340 ) , recently bereaved family ( n = 332 ) , physicians ( n = 361 ) , and other care providers ( nurses , social workers , chaplains , and hospice volunteers ; n = 429 ) . MAIN OUTCOME MEASURES Importance of 44 attributes of quality at the end of life ( 5-point scale ) and rankings of 9 major attributes , compared in the 4 groups . RESULTS Twenty-six items consistently were rated as being important ( > 70 % responding that item is important ) across all 4 groups , including pain and symptom management , preparation for death , achieving a sense of completion , decisions about treatment preferences , and being treated as a " whole person . " Eight items received strong importance ratings from patients but less from physicians ( P<.001 ) , including being mentally aware , having funeral arrangements planned , not being a burden , helping others , and coming to peace with God . Ten items had broad variation within as well as among the 4 groups , including decisions about life-sustaining treatments , dying at home , and talking about the meaning of death . Participants ranked freedom from pain most important and dying at home least important among 9 major attributes . CONCLUSIONS Although pain and symptom management , communication with one 's physician , preparation for death , and the opportunity to achieve a sense of completion are important to most , other factors important to quality at the end of life differ by role and by individual . Efforts to evaluate and improve patients ' and families ' experiences at the end of life must account for diverse perceptions of quality . JAMA . 2000;284:2476 - 2482 Objectives For the measurement of patient-reported outcomes , such as ( health-related ) quality of life , often many measurement instruments exist that intend to measure the same construct . To facilitate instrument selection , our aim was to develop a highly sensitive search filter for finding studies on measurement properties of measurement instruments in PubMed and a more precise search filter that needs less abstract s to be screened , but at a higher risk of missing relevant studies . Methods A r and om sample of 10,000 PubMed records ( 01 - 01 - 1990 to 31 - 12 - 2006 ) was used as a gold st and ard . Studies on measurement properties were identified using an exclusion filter and h and search ing . Search terms were selected from the relevant records in the gold st and ard as well as from 100 systematic review s of measurement properties and combined based on sensitivity and precision . The performance of the filters was tested in the gold st and ard as well as in two validation sets , by calculating sensitivity , precision , specificity , and number needed to read . Results We identified 116 studies on measurement properties in the gold st and ard . The sensitive search filter was able to retrieve 113 of these 116 studies ( sensitivity 97.4 % , precision 4.4 % ) . The precise search filter had a sensitivity of 93.1 % and a precision of 9.4 % . Both filters performed very well in the validation sets . Conclusion The use of these search filters will contribute to evidence -based selection of measurement instruments in all medical fields Patients with advanced cancer frequently express positive attitudes and can be unduly optimistic about the potential benefits of treatment . In order to evaluate an illusory domain in the context of advanced cancer , we developed a scale of will to live and characterized the beliefs that patients held about the curability of their cancer , and how committed they were to using alternative treatments . A measure of quality of life was used as the dependent variable in order to assess the association between these attributes . After a preliminary exploration confirmed the presence of an illusory domain , these concepts were prospect ively tested in 149 ambulant patients with advanced cancer who attended for palliative systemic treatment , radiation treatment or supportive care . The scale of global quality of life was reliable ( Cronbach 's alpha coefficient 0.72 ) . The distribution of the scores of will to live was skewed , with no respondent scoring poorly , and the scale was reliable ( Cronbach 's alpha coefficient 0.82 ) . The scale of belief in curability showed diverse beliefs . In some cases , there was a discrepancy between respondents ' beliefs in curability and what they believed to be the report by their doctors . There was also an association between a committed use of alternative treatments and a belief in the curability of the cancer ( p<0.001 ) . In a multiple regression analysis , both will to live and performance status remained associated with better quality of life scores after adjustment for other relevant variables ( p<0.05 and < 0.001 , respectively ) . These results suggest that positive illusory beliefs can be measured and are an important component of adaption for some patients with advanced cancer . Furthermore , this illusory domain may influence the perception and measurement of quality of life The aim of this study was to evaluate the feasibility , reliability and compliance of a new instrument , a diary to monitor physical symptoms for patients with cancer in the palliative phase of their illness . The development of the diary took place in three phases : two pilot studies and one intervention study . In Pilot I , reliability was tested within 13 pairs of patients and their proxy in a patient-proxy comparison . Pilot II was performed to test the feasibility of the instrument among 47 frail elderly . In the intervention study among patients with cancer in the palliative phase , the feasibility as well as the compliance has been tested . The phases have been completed with good results : reliability ( ICC ) of prevalent symptoms was above 0.75 , good feasibility and good compliance . The Symptom Monitor can be used by patients and doctors as an instrument to monitor physical symptoms . The effectiveness of the use of this diary for improvement in treatment of symptoms in the palliative phase of cancer is being tested in a r and omized clinical trial The Functional Assessment of Chronic Illness Therapy ( FACIT ) system provides a general , multidimensional measure of health-related quality of life ( FACT-G ) that can be augmented with disease or symptom-specific subscales . The 19-item palliative care subscale of the FACIT system has undergone little psychometric evaluation to date . The aim of this paper is to report the internal consistency , factor structure , and construct validity of the instrument using the palliative care subscale ( FACIT-Pal ) . Two hundred fifty-six persons with advanced cancer in a r and omized trial testing a palliative care psychoeducational intervention completed the 46-item FACIT-Pal at baseline . Internal consistency was greater than 0.74 for all subscales and the total score . Seventeen of the 19 palliative care subscale items loaded onto the four-factor solution of the established core measure ( FACT-G ) . As hypothesized , total scores were correlated with measures of symptom intensity ( r=-0.73 , P<0.001 ) and depression ( r=-0.75 , P<0.001 ) . The FACIT-Pal was able to discriminate between participants who died within three months of completing the baseline and participants who lived for at least one year after completing the baseline assessment ( t=-4.05 , P<0.001 ) . The functional well-being subscale discriminated between participants who had a Karnofsky performance score of 70 and below and participants with a Karnofsky performance score of 80 and above ( t=3.40 , P<0.001 ) . The findings support the internal consistency reliability and validity of the FACIT-Pal as a measure of health-related quality of life for persons with advanced cancer OBJECTIVE To determine the impact on a responder type analysis of using three published methods to obtain the minimally important difference ( MID ) on the conclusion of a r and omized controlled trial ( RCT ) . STUDY DESIGN AND SETTING Using data from an RCT of supportive-expressive group therapy ( SEGT-intervention ) vs. st and ard care ( control ) in women with metastatic breast cancer , we measured individual responsiveness to change according to three levels of predefined MID ( 0.2 SD , 0.5 SD , and 1 st and ard error of measurement ) of the following six vali date d question naires : Profile of Mood States , Impact of Event Scale , Psychosocial Adjustment to Illness Scale , EORTC Quality -of-Life Question naire Core-30 , Mental Adjustment to Cancer , and a pain visual analog scale . The proportion of women improved by SEGT and the number needed to treat according to three levels of MID were calculated . RESULTS There was no consistent difference in the net proportion of women improving with the SEGT vs. control arm according to the three different levels of MID . CONCLUSION The choice between different levels of distribution-based MID did not make an important difference in the net proportion of women improving with the SEGT . Future research should compare MID derived from clinical anchors , in particular patient opinions The purpose of the study was to investigate psychometric properties of CAMPAS-R , an instrument for prospect ively monitoring patients ' symptoms and needs during palliative care at home . CAMPAS-R was piloted for face and content validity and then administered alongside criterion measures to a home care sample . Cronbach 's alpha was used to test internal consistency and criterion-related validity was tested by non-parametric correlation with Brief Pain Inventory ( BPI ) , Hospital Anxiety and Depression Scale ( HADS ) and EORTC QLQ-C30 . Predictive validity was assessed by relating CAMPAS-R scores to survival . One hundred and nine patients were recruited to the study . Good reliability and high correlations between CAMPAS-R and criterion measures were found . Predictive validity was demonstrated by significant differences in symptom scores between groups differing in length of survival . CAMPAS-R is acceptable to patients , families and primary care professionals and is a valid , reliable instrument , which has the benefit of being easy to score A cross-validation of the Karnofsky Performance Status ( KPS ) and quality of life ( QOL ) as measured by item 30 of the quality of life question naire developed by the European Organization for Research and Treatment of Cancer Study Group ( EORTC QLQ-C30 ) was conducted using ordered logit analysis and prospect i ve data from a continuous sample of 139 lung cancer patients . The QOL is found to be a much broader concept than the KPS , since it likely captures not only physical functioning but also functioning in the non-physical dimensions of social , emotional , and possibly cognitive well-being as well as the level of distress in the physical dimensions of pain , breathing and fatigue . These results suggest that the palliative treatment of advanced cancer and the terminally ill should be guided by a broad concept of well-being that goes beyond one based only on physical functioning The purpose of this study was to establish whether or not readiness for death , as an indicator of healthy dying , is a measurable concept . Review of relevant literature revealed consensus regarding the universality of a human need for healthy dying . A theory of healthy dying was derived from the Rogerian paradigm . The McCanse Readiness for Death Instrument ( MRDI ) was constructed , which included indicators of physiological , psychological , sociological , and spiritual aspects of " healthy " field pattern as death is developmentally approached . The MRDI was a 26-item structured interview question naire which generated interval-ratio data through a visual analog scale . A pretest was conducted with a sample of 9 volunteer patients drawn from a small suburban outpatient hospice . The MRDI was concurrently administered to dying individuals , their primary caregivers , and their primary hospice nurses . Correlations between dying individuals ' scores and their primary caregivers ' estimates of patient death readiness as well as between patients and their primary hospice nurses were very encouraging . Cronbach 's coefficient alpha for internal consistency reliability was .59 . Content validity was supported by consensus of an expert panel of practicing hospice nurses . Construct validity was demonstrated through legitimate placement of the concept , healthy death readiness , within the theoretical web which supported it . The MRDI was then administered to a sample of 31 terminally-ill individuals , their primary caregivers , and their primary hospice nurses drawn from larger , urban hospice population s in three geographic areas of the United States . The MRDI was also administered to a contrast group of 39 cardiac-impaired individuals who were not terminally-ill . Overall internal consistency of the MRDI was found to be quite favorable ( alpha = .76 ) . Debilitating illness and actual mortality in the study sample precluded and /or confounded estimates of test-retest reliability . Convergent validity of the MRDI was indicated by significant correlations between patients ' scores and primary caregivers ' estimates ( r = .35 , p < .05 ) and between patients ' scores and primary hospice nurses ' estimates ( r = .53 , p < .01 ) . Discriminant validity of the MRDI was demonstrated by a significant mean difference between the group of terminally-ill patients and the group of non-terminal , cardiac-impaired patients
Output:
| None of the instruments demonstrated satisfactory results for all measurement properties .
Responsiveness was not tested adequately for any of the instruments .
Very few of the studies provided information on the interpretation of the scores .
Overall , the MQOL , followed by the QUAL-E and the QODD , received the best ratings for their measurement properties . |
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