PP-11 Comparing completion rates of paediatric versus adult randomised controlled trials: a cross-sectional study

2017 ◽  
Vol 102 (10) ◽  
pp. A34.2-A35
Author(s):  
Kaguelidou ◽  
Dufetelle
Keyword(s):  
Randomised Controlled Trials ◽  
Cross Sectional Study ◽  
Controlled Trials ◽  
Completion Rates ◽  
Sectional Study ◽  
Cross Sectional ◽  
Randomised Controlled

scholarly journals Risk of bias versus quality assessment of randomised controlled trials: cross sectional study

BMJ ◽  
2009 ◽  
Vol 339 (oct19 1) ◽  
pp. b4012-b4012 ◽  
Author(s):  
L. Hartling ◽  
M. Ospina ◽  
Y. Liang ◽  
D. M Dryden ◽  
N. Hooton ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Randomised Controlled Trials ◽  
Cross Sectional Study ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Sectional Study ◽  
Cross Sectional ◽  
Randomised Controlled ◽  
Bias Versus

scholarly journals Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e022233 ◽  
Author(s):  
Amanda Jane Blatch-Jones ◽  
Wei Pek ◽  
Emma Kirkpatrick ◽  
Martin Ashton-Key
Keyword(s):  
Feasibility Study ◽  
Randomised Controlled Trials ◽  
Feasibility Studies ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Cross Sectional ◽  
Group 2 ◽  
Randomised Controlled ◽  
Pilot Feasibility Study ◽  
Group 1

ObjectivesTo assess the value of pilot and feasibility studies to randomised controlled trials (RCTs) funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. To explore the methodological components of pilot/feasibility studies and how they inform full RCTs.Study designCross-sectional study.SettingBoth groups included NIHR HTA programme funded studies in the period 1 January 2010–31 December 2014 (decision date). Group 1: stand-alone pilot/feasibility studies published in the HTA Journal or accepted for publication. Group 2: all funded RCT applications funded by the HTA programme, including reference to an internal and/or external pilot/feasibility study. The methodological components were assessed using an adapted framework from a previous study.Main outcome measuresThe proportion of stand-alone pilot and feasibility studies which recommended proceeding to full trial and what study elements were assessed. The proportion of ‘HTA funded’ trials which used internal and external pilot and feasibility studies to inform the design of the trial.ResultsGroup 1 identified 15 stand-alone pilot/feasibility studies. Study elements most commonly assessed weretesting recruitment(100% in both groups),feasibility(83%, 100%) andsuggestions for further study/investigation(83%, 100%). Group 2 identified 161 ‘HTA funded’ applications: 59 cited an external pilot/feasibility study wheretesting recruitment(50%, 73%) andfeasibility(42%, 73%) were the most commonly reported study elements: 92 reported an internal pilot/feasibility study wheretesting recruitment(93%, 100%) andfeasibility(44%, 92%) were the most common study elements reported.Conclusions‘HTA funded’ research which includes pilot and feasibility studies assesses a variety of study elements. Pilot and feasibility studies serve an important role when determining the most appropriate trial design. However, how they are reported and in what context requires caution when interpreting the findings and delivering a definitive trial.

scholarly journals Analysis of conference abstracts of prosthodontic randomised-controlled trials presented at IADR general sessions (2002–2015): a cross-sectional study of the relationship between demographic characteristics, reporting quality and final publication

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034635
Author(s):  
Junsheng Chen ◽  
Yubin Cao ◽  
Meijie Wang ◽  
Xueqi Gan ◽  
Chunjie Li ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Reporting Quality ◽  
Cross Sectional Study ◽  
Publication Rate ◽  
Demographic Characteristics ◽  
Sectional Study ◽  
Cross Sectional ◽  
Randomised Controlled ◽  
The Relationship

ObjectivesTo analyse the relationship between demographic characteristics, reporting quality and final publication rate of conference abstracts of prosthodontic randomised-controlled trials (RCTs) presented at International Association for Dental Research (IADR) general sessions (2002–2015).DesignA cross-sectional study on conference abstracts.MethodsConference abstracts of prosthodontic RCTs presented at IADR general sessions (2002–2015) were obtained. Literature search was performed in multiple databases to confirm the final publication status of conference abstracts. Two investigators independently extracted the data including conference date, origin, presentation type, exact p value, number of centres, institution type, overall conclusion, subspecialty, publication time and journal. The reporting quality of abstracts was assessed by two investigators according to the Consolidated Standards of Reporting Trials statement. The relationship between demographic characteristics, reporting quality and final publication was analysed by χ2test.Setting, participants and interventionsNot applicable.Primary and secondary outcome measuresFinal publication rate, demographic characteristics and reporting quality of conference abstracts of prosthodontic RCTs presented at IADR general sessions (2002–2015).ResultsOf the 340 prosthodontic RCT abstracts, 43.24% were published. The mean time to final publication was 22.86 months. Europe contributed the most number of abstracts but Asia and Australia had the highest publication rate. Oral presentation, multicentre trial and complete denture and overdenture subspecialty were associated with a higher publication rate. Reporting quality of eligibility criteria of participants, random assignment and primary outcome results for each group correlated with a higher final publication rate.ConclusionsOver half of conference abstracts of prosthodontic RCTs presented at IADR general sessions (2002–2015) were unpublished. Oral presentation and multiple centres were associated with higher publication rates. Abstracts’ reporting quality addressing participant recruitment, assignment and primary results correlated with trials’ validity and applicability. Conference attendees may refer to this research to identify valid and applicable prosthodontic trials but should treat and apply results cautiously.

scholarly journals A protocol of a cross-sectional study evaluating an online tool for early career peer reviewers assessing reports of randomised controlled trials

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e017462 ◽  
Author(s):  
Anthony Chauvin ◽  
David Moher ◽  
Doug Altman ◽  
David L Schriger ◽  
Sabina Alam ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Cross Sectional Study ◽  
Early Career ◽  
Sectional Study ◽  
Cross Sectional ◽  
Online Tool ◽  
Peer Reviewers ◽  
The Mean ◽  
Randomised Controlled ◽  
Completeness Of Reporting

IntroductionSystematic reviews evaluating the impact of interventions to improve the quality of peer review for biomedical publications highlighted that interventions were limited and have little impact. This study aims to compare the accuracy of early career peer reviewers who use an innovative online tool to the usual peer reviewer process in evaluating the completeness of reporting and switched primary outcomes in completed reports.Methods and analysisThis is a cross-sectional study of individual two-arm parallel-group randomised controlled trials (RCTs) published in the BioMed Central series medical journals,BMJ,BMJ OpenandAnnals of Emergency Medicineand indexed with the publication type ‘Randomised Controlled Trial’. First, we will develop an online tool and training module based (a) on the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist and the Explanation and Elaboration document that would be dedicated to junior peer reviewers for assessing the completeness of reporting of key items and (b) the Centre for Evidence-Based Medicine Outcome Monitoring Project process used to identify switched outcomes in completed reports of the primary results of RCTs when initially submitted. Then, we will compare the performance of early career peer reviewers who use the online tool to the usual peer review process in identifying inadequate reporting and switched outcomes in completed reports of RCTs at initial journal submission. The primary outcome will be the mean number of items accurately classified per manuscript. The secondary outcomes will be the mean number of items accurately classified per manuscript for the CONSORT items and the sensitivity, specificity and likelihood ratio to detect the item as adequately reported and to identify a switch in outcomes. We aim to include 120 RCTs and 120 early career peer reviewers.Ethics and disseminationThe research protocol was approved by the ethics committee of the INSERM Institutional Review Board (21 January 2016). The study is based on voluntary participation and informed written consent.Trial registration numberNCT03119376.

scholarly journals Vitamin D deficiency and depression in adults: systematic review and meta-analysis

2013 ◽  
Vol 202 (2) ◽  
pp. 100-107 ◽  
Author(s):  
Rebecca E. S. Anglin ◽  
Zainab Samaan ◽  
Stephen D. Walter ◽  
Sarah D. McDonald
Keyword(s):  
Systematic Review ◽  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cross Sectional ◽  
Cross Sectional Studies ◽  
Randomised Controlled ◽  
The Relationship

BackgroundThere is conflicting evidence about the relationship between vitamin D deficiency and depression, and a systematic assessment of the literature has not been available.AimsTo determine the relationship, if any, between vitamin D deficiency and depression.MethodA systematic review and meta-analysis of observational studies and randomised controlled trials was conducted.ResultsOne case-control study, ten cross-sectional studies and three cohort studies with a total of 31 424 participants were analysed. Lower vitamin D levels were found in people with depression compared with controls (SMD = 0.60,95% Cl 0.23–0.97) and there was an increased odds ratio of depression for the lowest v. highest vitamin D categories in the cross-sectional studies (OR = 1.31, 95% CI 1.0–1.71). The cohort studies showed a significantly increased hazard ratio of depression for the lowest v. highest vitamin D categories (HR=2.21, 95% CI 1.40–3.49).ConclusionsOur analyses are consistent with the hypothesis that low vitamin D concentration is associated with depression, and highlight the need for randomised controlled trials of vitamin D for the prevention and treatment of depression to determine whether this association is causal.

scholarly journals ‘Not clinically effective but cost-effective’ - paradoxical conclusions in randomised controlled trials with ‘doubly null’ results: a cross-sectional study

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e029596 ◽  
Author(s):  
James Raftery ◽  
HC Williams ◽  
Aileen Clarke ◽  
Jim Thornton ◽  
John Norrie ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Technology Assessment ◽  
Randomised Controlled Trials ◽  
Cost Effective ◽  
Health Technology ◽  
Controlled Trials ◽  
Cross Sectional ◽  
Null Results ◽  
Health Technology Assessment Programme ◽  
Randomised Controlled

ObjectivesRandomised controlled trials in healthcare increasingly include economic evaluations. Some show small differences which are not statistically significant. Yet these sometimes come to paradoxical conclusions such as: ‘the intervention is not clinically effective’ but ‘is probably cost-effective’. This study aims to quantify the extent of non-significant results and the types of conclusions drawn from them.DesignCross-sectional retrospective analysis of randomised trials published by the UK’s National Institute for Health Research (NIHR) Health Technology Assessment programme. We defined as ‘doubly null’ those trials that found non-statistically significant differences in both primary outcome and cost per patient. Paradoxical was defined as concluding in favour of an intervention, usually compared with placebo or usual care. No human participants were involved. Our sample was 226 randomised trial projects published by the Health Technology Assessment programme 2004 to 2017. All are available free online.ResultsThe 226 projects contained 193 trials with a full economic evaluation. Of these 76 (39%) had at least one ‘doubly null’ comparison. These 76 trials contained 94 comparisons. In these 30 (32%) drew economic conclusions in favour of an intervention. Overall report conclusions split roughly equally between those favouring the intervention (14), and those favouring either the control (7) or uncertainty (9).DiscussionTrials with ‘doubly null’ results and paradoxical conclusions are not uncommon. The differences observed in cost and quality-adjustedlife year were small and non-statistically significant. Almost all these trials were also published in leading peer-reviewed journals. Although some guidelines for reporting economic results require cost-effectiveness estimates regardless of statistical significance, the interpretability of paradoxical results has nowhere been addressed.ConclusionsReconsideration is required of the interpretation of cost-effectiveness analyses in randomised controlled trials with ‘doubly null’ results, particularly when economics favours a novel intervention.

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