***TASK*** the task is to summarize an input biomedical literature 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 conduct of r and omized , controlled trials of nonpharmacologic treatments presents specific challenges that are not adequately addressed in trial reports . OBJECTIVE To develop an extension of the CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement for trials of nonpharmacologic treatments . DESIGN A consensus meeting was organized to develop an extension of the CONSORT Statement that addresses r and omized trials of nonpharmacologic treatments . To prepare for the meeting , a survey was conducted to identify the specific issues for discussion . SETTING Consensus meeting in Paris , France . PARTICIPANTS A total of 33 experts attended the meeting . The experts were method ologists ( n = 17 ) ; surgeons ( n = 6 ) ; editors ( n = 5 ) ; and clinicians involved in rehabilitation ( n = 1 ) , psychotherapy ( n = 2 ) , education ( n = 1 ) , and implantable devices ( n = 1 ) . MEASUREMENTS Experts indicated which of the 22 items on the CONSORT checklist should be modified or which additional items should be added specifically for nonpharmacologic treatments . During a 3-day consensus meeting , all items were discussed and additional method ological issues related to nonpharmacologic research were identified . RESULTS The consensus was that 11 items on the CONSORT checklist needed some modifications for nonpharmacologic trials : item 1 ( title and abstract ) , item 3 ( participants ) , item 4 ( interventions ) , item 7 ( sample size ) , item 8 ( r and omization ) , item 11 ( blinding ) , item 12 ( statistical methods ) , item 13 ( participant flow ) , item 15 ( baseline data ) , item 20 ( discussion : interpretation ) , and item 21 ( generalizability ) . In addition , the meeting participants added 1 item related to implementation of the intervention . LIMITATION Evidence was not always available to support the inclusion of each checklist item . CONCLUSION The methods and processes used to develop this extension could be used for other reporting guidelines . The use of this extension to the CONSORT Statement should improve the quality of reporting r and omized , controlled trials assessing nonpharmacologic treatments Abstract Objective To examine the extent and nature of outcome reporting bias in a broad cohort of published r and omised trials . Design Retrospective review of publications and follow up survey of authors . Cohort All journal articles of r and omised trials indexed in PubMed whose primary publication appeared in December 2000 . Main outcome measures Prevalence of incompletely reported outcomes per trial ; reasons for not reporting outcomes ; association between completeness of reporting and statistical significance . Results 519 trials with 553 publications and 10 557 outcomes were identified . Survey responders ( response rate 69 % ) provided information on unreported outcomes but were often unreliable — for 32 % of those who denied the existence of such outcomes there was evidence to the contrary in their publications . On average , over 20 % of the outcomes measured in a parallel group trial were incompletely reported . Within a trial , such outcomes had a higher odds of being statistically non-significant compared with fully reported outcomes ( odds ratio 2.0 ( 95 % confidence interval 1.6 to 2.7 ) for efficacy outcomes ; 1.9 ( 1.1 to 3.5 ) for harm outcomes ) . The most commonly reported reasons for omitting efficacy outcomes included space constraints , lack of clinical importance , and lack of statistical significance . Conclusions Incomplete reporting of outcomes within published articles of r and omised trials is common and is associated with statistical non- significance . The medical literature therefore represents a selective and biased subset of study outcomes , and trial protocol s should be made publicly available OBJECTIVE : This study was design ed to develop and to test a home-based , guided imagery treatment protocol , using audio and video recordings , that is easy for health care professionals and patients to use , is inexpensive , and is applicable to a wide range of health care setting s. METHODS : Thirty-four children , 6 to 15 years of age , with a physician diagnosis of functional abdominal pain were assigned r and omly to receive 2 months of st and ard medical care with or without home-based , guided imagery treatment . Children who received only  st and ard medical care initially received guided imagery treatment after 2 months . Children were monitored for 6 months after completion of guided imagery treatment . RESULTS : All treatment material s were reported to be self-explanatory , enjoyable , and easy to underst and and to use . The compliance rate was 98.5 % . In an intention-to-treat analysis , 63.1 % of children in the guided imagery treatment group were treatment responders , compared with 26.7 % in the st and ard medical care – only group ( P = .03 ; number needed to treat : 3 ) . Per- protocol analysis showed similar results ( 73.3 % vs 28.6 % responders ) . When the children in the st and ard medical care group also received guided imagery treatment , 61.5 % became treatment responders . Treatment effects were maintained for 6 months ( 62.5 % responders ) . CONCLUSION : Guided imagery treatment plus medical care was superior to st and ard medical care only for the treatment of abdominal pain , and treatment effects were sustained over a long period Forty-eight adolescents suffering from recurrent tension headache participated in a controlled trial conducted in a high school setting . During the first treatment phase self-help relaxation training was compared with a waiting-list group . Following this phase a pharmacological regimen consisting of a muscle relaxant ( chlormezanone ) and placebo was superimposed on relaxation therapy in a double-blind crossover design . Each treatment phase encompassed a 5-week period . In addition to the evaluation of headache complaints , psychological distress among students  was measured with respect to their experience of somatic complaints , depressive , anxiety and stress symptoms . Although self-help relaxation training significantly decreased the severity and annoyance of adolescents ' headache besides their somatic complaints , the clinical improvement of headache was modest . The addition of chlormezanone did not help those who were nonresponders to self-help relaxation training . Finally , a set of pretreatment variables consisting of baseline headache severity and annoyance , experience of anxiety and daily life stress among adolescents could predict outcome of self-help relaxation therapy A comparison was carried out of the efficacy of psychological and drug treatments for children with migraine . Forty-three children aged between 8 and 16 years ( mean age : 11.3 years ) who suffered from migraine received either progressive relaxation or cephalic vasomotor feedback , both with stress management training , or metoprolol , a beta-blocker . Psychological treatment was administered in ten sessions lasting six weeks and the drug treatment lasted ten weeks . Relaxation and stress management training reduced the headache index ( frequency x intensity of headache episodes ) , more effectively than metoprolol with cephalic vasomotor feedback and stress management training in between . An overall improvement over time was found with regard to frequency and intensity of headache episodes and analgesics intake . When comparing pre- to post-treatment data , children treated with relaxation training improved significantly in headache frequency and intensity , whereas those treated with cephalic vasomotor feedback improved significantly in headache frequency and duration as well as mood . The clinical improvement was stable at an 8-months follow-up This study describes the results of a controlled clinical trial involving 44 7- to 14-year-old children with recurrent abdominal pain who were r and omly allocated to either cognitive-behavioral family intervention ( CBFI ) or st and ard pediatric care ( SPC ) .  Both treatment conditions result ed in significant improvements on measures of pain intensity and pain behavior . However , the children receiving CBFI had a higher rate of complete elimination of pain , lower levels of relapse at 6- and 12-month follow-up , and lower levels of interference with their activities as a result of pain and parents reported a higher level of satisfaction with the treatment than children receiving SPC . After controlling for pretreatment levels of pain , children 's active self-coping and mothers ' caregiving strategies were significant independent predictors of pain behavior at posttreatment 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 : We evaluated the efficacy of cognitive-behavioral family intervention in the treatment of crises of pain in children with nonorganic recurrent abdominal pain ( RAP ) and the thresholds of pain for 17 body surface areas in these children . Methods : A r and omized clinical trial was undertaken with 32 children between the ages of 5.1 and 13.9 years with nonorganic RAP . A group of 15 patients , aged 9.9 ± 2.2 years ( 11 girls ) , received st and ard pediatric care and cognitive-behavioral family intervention for treatment of pain crises . The control group of 17 children , aged 8.4 ± 2.0 years ( 11 girls ) , received only st and ard pediatric care . These procedures were undertaken by general pediatricians over 4 monthly sessions . An analog visual scale was used to measure the frequency and intensity of the pain crises per month and a mechanical pressure algometer for the measurement of pain threshold . Results : The median frequency of pain crises per month reported by patients at the 3 monthly cognitive-behavioral family intervention sessions was 15 , 5 , 2 and 2 , respectively . In contrast , the median frequency for pain crises per month reported by the control group was 12 , 8 , 10 and 8 , respectively . The difference between the intervention group and the controls was statistically significant for frequency of pain at the second , third and fourth visits . There was no statistical difference for intensity of pain or for measured pain thresholds between the control and the intervention group . Conclusions : The cognitive-behavioral family intervention reduced the frequency of pain crises of children with nonorganic RAP . This successful intervention was carried out by the intervention of general pediatricians OBJECTIVE Juvenile fibromyalgia syndrome ( FMS ) is a chronic musculoskeletal pain disorder in children and adolescents for which there are no evidence -based treatments . The objective of this multisite , single-blind , r and omized clinical trial was to test whether cognitive-behavioral therapy ( CBT ) was superior to fibromyalgia ( FM ) education in reducing functional disability , pain , and symptoms of depression in juvenile FMS . METHODS Participants were 114 adolescents ( ages 11 - 18 years ) with juvenile FMS . After receiving stable medications for 8 weeks , patients were r and omized to either CBT or FM education and received 8 weekly individual sessions with a therapist and 2 booster sessions . Assessment s were conducted at baseline , immediately following the 8-week treatment phase , and at 6-month followup . RESULTS The majority of patients ( 87.7 % ) completed the trial per protocol . Intent-to-treat analyses showed that patients in both groups had significant reductions in functional disability , pain , and symptoms of depression at the end of the study , and CBT was significantly superior to FM education in reducing the primary outcome of functional disability ( mean baseline to end-of-treatment difference between groups 5.39 [ 95 % confidence interval 1.57 , 9.22 ] ) . Reduction in symptoms of depression was clinical ly significant for both groups , with mean scores in the range of normal/nondepressed by the end of the study . Reduction in pain was not clinical ly significant for either group ( < 30 % decrease in pain ) . There were no study -related adverse events . CONCLUSION In this controlled trial , CBT was found to be a safe and effective treatment for reducing functional disability and symptoms of depression in adolescents with juvenile FMS & NA ; Little is known about the epidemiology of pain in children . We studied the prevalence of pain in Dutch children aged from 0 to 18 years in the open population , and the relationship with age , gender and pain parameters . A r and om sample of 1300 children aged 0–3 years was taken from the register of population in Rotterdam , The Netherl and s. In the Rotterdam area , 27 primary schools and 14 secondary schools were selected to obtain a representative sample of 5336 children aged 4–18 years . Depending on the age of the child , a question naire was either mailed to the parents ( 0–3 years ) or distributed at school ( 4–18 years ) . Of 6636 children surveyed , 5424 ( 82 % ) responded ; response rates ranged from 64 to 92 % , depending on the subject age and who completed the question naire . Of the respondents , 54 % had experienced pain within the previous 3 months . Overall , a quarter of the respondents reported chronic pain ( recurrent or continuous pain for more than 3 months ) . The prevalence of chronic pain increased with age , and was significantly higher for girls ( P<0.001 ) . In girls , a marked increase 
    Output:
    
RESULTS 35 included studies revealed that across all chronic pain conditions , psychological interventions  reduced pain symptoms and disability posttreatment .
For headache pain , higher treatment dose led to greater reductions in pain .
No effect of dosage was found for other chronic pain conditions .