***TASK*** the task is to summarize an input biomedical literature 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 Reporting of r and omized controlled trials  ( RCTs ) should be of high quality to support the conclusions reached by the authors . Poor- quality reporting has been associated with an overestimation in intervention efficacy . Within the field of paediatric dentistry , no study has assessed the quality of reporting . OBJECTIVE The aim of this study was to assess published RCTs in paediatric dental journals between 1985 and 2006 for : ( i ) whether quality of reporting allows readers to assess the validity of trials ; and ( ii ) whether quality of reporting has improved since the introduction of the Consoli date d St and ards of Reporting Trials ( CONSORT ) guidelines . METHODS H and search of the main paediatric dentistry journals ; inclusion criteria were : the trial was performed on children , and RCT . CONSORT guidelines were made into an operational checklist . Trials published between 1985 and 1997 , and between 1998 and 2006 were compared to determine any improvement since the publication of the CONSORT guidelines . RESULTS One hundred and seventy-three of 5635 articles met the inclusion criteria .  Reporting quality was poor overall and showed heterogeneity . It had improved slightly since the publication of CONSORT . Few trials were reported adequately . CONCLUSION The quality of reporting of clinical trials is poor , and often not adequate to allow readers to assess trial validity . Overall quality of reporting has not substantially improved since the publication of CONSORT There is consensus that children have question able decisional capacity and , therefore , in general a parent or a guardian must give permission to enroll a child in a research study . Moreover , freedom from duress and coercion , the cardinal rule in research involving adults , is even more important for children . This principle is embodied prominently in the Nuremberg Code ( 1947 ) and is embodied in various federal human research protection regulations . In a program named " SATURN " ( Student Athletic Testing Using R and om Notification ) , each school in the Oregon public-school system may implement a m and atory drug-testing program for high school student athletes . A prospect i ve study to identify drug use among student-athletes , SATURN is design ed both to evaluate the influence of r and om drug testing and to vali date the survey data through identification of individuals who do not report drug use . The enrollment of students in the drug-testing study is a requirement for playing a school sport . In addition to the coercive nature of this study design , there were ethically question able practice s in recruitment , informed consent , and confidentiality . This article concerns the question of whether research can be conducted with high school students in conjunction with a m and atory drug-testing program , while adhering to prevailing ethical st and ards regarding human-subjects research and specifically the participation of children in research Background All r and omized clinical trials ( RCTs ) require a protocol ; however , numerous studies have highlighted protocol deficiencies . Reporting guidelines may improve the content of research reports and , if developed using robust methods , may increase the utility of reports to stakeholders . The objective of this study was to systematic ally identify and review RCT protocol guidelines , to assess their characteristics and methods of development , and to compare recommendations . Methods We conducted a systematic review of indexed literature ( MEDLINE , EMBASE and the Cochrane Methodology Register from inception to September 2010 ; reference lists ; related article features ; forward citation search ing ) and a targeted search of supplementary sources , including a survey of major trial funding agencies in six countries . Records were eligible if they described a content guideline in English or French relevant to RCT protocol s. Guidelines were excluded if they specified content for protocol s for trials of specific procedures or conditions or were intended to assess trial quality . We extracted guideline characteristics and methods . Content was mapped for a subset of guidelines that described development methods or had institutional endorsement . Results Forty guidelines published in journals , books and institutional reports were included in the review ; seven were specific to RCT protocol s. Only eight ( 20 % ) described development methods which included informal consensus methods , pilot testing and formal validation ; no guideline described all of these methods . No guideline described formal consensus methods or a systematic retrieval of empirical evidence to inform its development . The guidelines included a median of 23 concepts per guideline ( interquartile range ( IQR ) = 14 to 34 ; range = 7 to 109 ) . Among the subset of guidelines ( n = 23 ) for which content was mapped , approximately 380 concepts were explicitly addressed ( median concepts per guideline IQR = 31 ( 24,80 ) ; range = 16 to 150 ) ; most concepts were addressed in a minority of guidelines . Conclusions Existing guidelines for RCT protocol content varied substantially in their recommendations . Few reports described the methods of guideline development , limiting comparisons of guideline validity . Given the importance of protocol s to diverse stakeholders , we believe a systematic ally developed , evidence -informed guideline for clinical trial protocol s is needed BACKGROUND Despite the high prevalence and negative physical and psychosocial consequences of overweight and obesity in adolescents , very little research has evaluated treatment in this population . Consequently , clinicians working with overweight and obese adolescents have little empirical research on which to base their practise . Cognitive behavioural therapy has demonstrated efficacy in promoting behaviour change in many treatment resistant disorders . Motivational interviewing has been used to increase motivation for change and improve treatment outcomes . In this paper we describe the rationale and design of a r and omised controlled trial testing the efficacy of motivational interviewing and cognitive behaviour therapy in the treatment of overweight and obese adolescents . METHODS Participants took part in a  motivational interview or a st and ard semi-structured assessment interview and were then r and omly allocated to a cognitive behavioural intervention or a wait-list control condition . The cognitive behavioural intervention , the CHOOSE HEALTH Program , consisted of 13 individual treatment sessions ( 12 face-to-face , 1 phone call ) followed by 9 maintenance sessions ( 7 phone calls , 2 face-to-face ) . Assessment s were conducted prior to participation , after the treatment phase and after the maintenance phase of intervention . Improvement in body composition was the primary outcome ; secondary outcomes included improved cardiovascular fitness , eating and physical activity habits , family and psychosocial functioning . CONCLUSION Despite the demonstrated effectiveness of motivational interviewing and cognitive behavioural therapy in the long-term management of many treatment resistant disorders , these approaches have been under-utilised in adolescent overweight and obesity treatment . This study provides baseline data and a thorough review of the study design and treatment approach to allow for the assessment of the efficacy of motivational interviewing and cognitive behavioural therapy in the treatment of adolescent overweight and obesity . Data obtained in this study will also provide much needed information about the behavioural and psychosocial factors associated with adolescent overweight and obesity Purpose This article is aim ed at describing the methodology of “ ethical reasoning ” that finally led TEDDYNoE ( Task-force in Europe for Drug Development for the Young ) to propose the integration of international human rights law to develop coherent and exhaustive ethical recommendations on paediatric research at a European level . Methods A large number of ethical guidelines and texts of varying legal force existing in the field of clinical research and in particular related to paediatrics are analysed . Differences and non-coordinated implementation are pointed out . Results Differences , tensions or outright contradictions among the provisions of these texts can generate confusion leading to the adoption of different ethical st and ards across Europe . In this context , the real challenge is to ensure that each child involved in a clinical trial in the EU territory may rely directly on the same principles and rights . Taking international human rights law as the main starting point to develop a coherent framework for paediatric research that incorporates all the relevant ethical considerations and existing guidelines is a way of achieving this objective . Conclusions The implementation , at national and local level , of the “ European Ethical Recommendations ” ( Eudralex 2008 vol . 10 ) , based on international human rights law , seems to be the next step in facilitating a coordinated approach to the application of the Directive 2001/20/EC , as well as developing quality and ethically sound paediatric research Cortisol does not exhibit a straightforward relationship with mood states ; administration of glucocorticoids to human subjects has produced mixed effects on mood and emotional processing . In this study , participants ( N=46 ) received intravenous hydrocortisone ( synthetic cortisol ; 0.1mg/kg body weight ) and placebo in r and omized order over two sessions 48h apart . Following the infusion , participants rated neutral and unpleasant pictures . In Session 1 , participants reported elevated negative affect ( NA ) following the picture-rating task , regardless of treatment . In Session 2 , however , only participants who received cortisol ( and thus who had received placebo in Session 1 ) reported elevated NA . Arousal ratings for unpleasant pictures followed a similar pattern . These findings suggest that the effects of cortisol on emotion vary based on situational factors , such as drug administration order or familiarity with the tasks and setting . Such factors can influence cortisol 's effects on emotion in two ways : ( A ) cortisol may only potentiate NA and arousal ratings in the absence of other , overwhelming influences on affect , such as the novelty of the setting and tasks in Session 1 ; and ( B ) cortisol in Session 1 may facilitate learning processes ( e.g. , habituation to the stimuli and setting ; extinction of aversive responses ) such that emotional responses to the pictures are lessened in Session 2 . This interpretation is compatible with a body of literature on the effects of glucocorticoids on learning and memory processes CONTEXT Selective reporting of outcomes within published studies based on the nature or direction of their results has been widely suspected , but direct evidence of such bias is currently limited to case reports . OBJECTIVE To study empirically the extent and nature of outcome reporting bias in a cohort of r and omized trials . DESIGN Cohort study using protocol s and published reports of r and omized trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg , Denmark , in 1994 - 1995 . The number and characteristics of reported and unreported trial outcomes were recorded from protocol s , journal articles , and a survey of trialists . An outcome was considered incompletely reported if insufficient data were presented in the published articles for meta- analysis . Odds ratios relating the completeness of outcome reporting to statistical significance were calculated for each trial and then pooled to provide an overall estimate of bias . Protocol s and published articles were also compared to identify discrepancies in primary outcomes . MAIN OUTCOME MEASURES Completeness of reporting of efficacy and harm outcomes and of statistically significant vs nonsignificant outcomes ; consistency between primary outcomes defined in the most recent protocol s and those defined in published articles . RESULTS One hundred two trials with 122 published journal articles and 3736 outcomes were identified . Overall , 50 % of efficacy and 65 % of harm outcomes per trial were incompletely reported . Statistically significant outcomes had a higher odds of being fully reported compared with nonsignificant outcomes for both efficacy ( pooled odds ratio , 2.4 ; 95 % confidence interval [ CI ] , 1.4 - 4.0 ) and harm ( pooled odds ratio , 4.7 ; 95 % CI , 1.8 - 12.0 ) data . In comparing published articles with protocol s , 62 % of trials had at least 1 primary outcome that was changed , introduced , or omitted . Eighty-six percent of survey responders ( 42/49 ) denied the existence of unreported outcomes despite clear evidence to the contrary . CONCLUSIONS The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocol s. Published articles , as well as review s that incorporate them , may therefore be unreliable and overestimate the benefits of an intervention . To ensure transparency , planned trials should be registered and protocol s should be made publicly available prior to trial completion Objective To evaluate how often sample size calculations and methods of statistical analysis are pre-specified or changed in r and omised trials . Design Retrospective cohort study . Data source Protocol s and journal publications of published r and omised parallel group trials initially approved in 1994 - 5 by the scientific-ethics committees for Copenhagen and Frederiksberg , Denmark ( n=70 ) . Main outcome measure Proportion of protocol s and publications that did not provide key information about sample size calculations and statistical methods ; proportion of trials with discrepancies between information presented in the protocol and the publication . Results Only 11/62 trials described existing sample size calculations fully and consistently in both the protocol and the publication . The method of h and ling protocol deviations was described in 37 protocol s and 43 publications . The method of h and ling missing data was described in 16 protocol s and 49 publications . 39/49 protocol s and 42/43 publications reported the statistical test used to analyse primary outcome measures . Unacknowledged discrepancies between protocol s and publications were found for sample size calculations ( 18/34 trials ) , methods of h and ling protocol deviations ( 19/43 ) and missing data ( 39/49 ) , primary outcome analyses ( 25/42 ) , subgroup analyses ( 25/25 ) , and adjusted analyses ( 23/28 ) . Interim analyses were described in 13 protocol s but mentioned in only five corresponding publications . Conclusion When reported in publications , sample size calculations and statistical methods were often explicitly discrepant with the protocol or not pre-specified . Such amendments were rarely acknowledged in the trial publication . The reliability of trial reports can not be assessed without having access to the full protocol The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . Treating malaria before immunizing 
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Conclusion These systematic review s are the first to systematic ally gather evidence and recommendations for the reporting of specific items in pediatric protocol s and trials .
They provide useful and translatable evidence on which to build pediatric extensions to the SPIRIT and CONSORT reporting guidelines .
The result ing SPIRIT-C and CONSORT-C will provide guidance to the authors of pediatric protocol s and reports , respectively , helping to alleviate concerns of inappropriate and inconsistent reporting , and reduce research waste