scholarly journals Data-sharing recommendations in biomedical journals and randomised controlled trials: an audit of journals following the ICMJE recommendations

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e038887
Author(s):  
Maximilian Siebert ◽  
Jeanne Fabiola Gaba ◽  
Laura Caquelin ◽  
Henri Gouraud ◽  
Alain Dupuy ◽  
...  
Keyword(s):  
Medical Journal ◽  
Data Sharing ◽  
Randomised Controlled Trials ◽  
Primary Outcome ◽  
Controlled Trials ◽  
Cross Sectional Survey ◽  
Eligibility Criteria ◽  
Cross Sectional ◽  
Data Set ◽  
Randomised Controlled

ObjectiveTo explore the implementation of the International Committee of Medical Journal Editors (ICMJE) data-sharing policy which came into force on 1 July 2018 by ICMJE-member journals and by ICMJE-affiliated journals declaring they follow the ICMJE recommendations.DesignA cross-sectional survey of data-sharing policies in 2018 on journal websites and in data-sharing statements in randomised controlled trials (RCTs).SettingICMJE website; PubMed/Medline.Eligibility criteriaICMJE-member journals and 489 ICMJE-affiliated journals that published an RCT in 2018, had an accessible online website and were not considered as predatory journals according to Beall’s list. One hundred RCTs for member journals and 100 RCTs for affiliated journals with a data-sharing policy, submitted after 1 July 2018.Main outcome measuresThe primary outcome for the policies was the existence of a data-sharing policy (explicit data-sharing policy, no data-sharing policy, policy merely referring to ICMJE recommendations) as reported on the journal website, especially in the instructions for authors. For RCTs, our primary outcome was the intention to share individual participant data set out in the data-sharing statement.ResultsEight (out of 14; 57%) member journals had an explicit data-sharing policy on their website (three were more stringent than the ICMJE requirements, one was less demanding and four were compliant), five (35%) additional journals stated that they followed the ICMJE requirements, and one (8%) had no policy online. In RCTs published in these journals, there were data-sharing statements in 98 out of 100, with expressed intention to share individual patient data reaching 77 out of 100 (77%; 95% CI 67% to 85%). One hundred and forty-five (out of 489) ICMJE-affiliated journals (30%; 26% to 34%) had an explicit data-sharing policy on their website (11 were more stringent than the ICMJE requirements, 85 were less demanding and 49 were compliant) and 276 (56%; 52% to 61%) merely referred to the ICMJE requirements. In RCTs published in affiliated journals with an explicit data-sharing policy, data-sharing statements were rare (25%), and expressed intentions to share data were found in 22% (15% to 32%).ConclusionThe implementation of ICMJE data-sharing requirements in online journal policies was suboptimal for ICMJE-member journals and poor for ICMJE-affiliated journals. The implementation of the policy was good in member journals and of concern for affiliated journals. We suggest the conduct of continuous audits of medical journal data-sharing policies in the future.RegistrationThe protocol was registered before the start of the research on the Open Science Framework (https://osf.io/n6whd/).

scholarly journals Definitions of blinding in randomised controlled trials of interventions published in high-impact anaesthesiology journals: a methodological study and survey of authors

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e035168 ◽  
Author(s):  
Antonija Penić ◽  
Dinka Begić ◽  
Karolina Balajić ◽  
Martin Kowalski ◽  
Ana Marušić ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Methodological Study ◽  
Cross Sectional Survey ◽  
Open Label ◽  
Double Blind ◽  
Cross Sectional ◽  
The Status ◽  
Peer Reviewers ◽  
Randomised Controlled

ObjectivesTo analyse the completeness of reporting of blinding in randomised controlled trials (RCTs) of interventions in anaesthesiology, the actual blinding status of various persons associated with an RCT and trial authors’ interpretation of blinding terminology related to RCTs.MethodsThis was a methodological study and a cross-sectional survey. We analysed reporting related to blinding in published RCTs of interventions published in seven highly cited anaesthesiology journals from 2014 to 2016 and registered protocols in ClinicalTrials.gov. We surveyed corresponding authors of included RCTs about their definitions of blinding. The primary outcome was the number of RCTs that explicitly described who was blinded in a trial. Secondary outcomes were definitions of blinding terminology in the trials; trial authors’ interpretation of blinding terminology; discrepancies in the blinding description within registered protocols and between registered protocols and publications.ResultsOut of 622 analysed RCTs, 38% were not explicitly described as either open label or blinded studies and 10% did not report any information about blinding or lack of blinding. Only one manuscript fully reported the status of blinding for various individuals that may be involved with a trial. The most common descriptor was that a trial was double-blind. We found discrepant information regarding blinding in the majority of registered protocols. Even when there were no discrepancies in the registration, we found discrepancies in the reporting of blinding between the majority of registered protocols and published manuscripts. The survey of authors (40 responses from 231 eligible authors; 17% response rate) of analysed RCTs showed that they differed in how they defined different levels of blinding in trials.ConclusionsReporting of the blinding status of key individuals involved in analysed anaesthesiology RCTs was insufficient. For reporting guidelines, peer reviewers and editors should insist on clear information on who was blinded in a trial instead of using the term ‘double-blind’ for different blinding practices.

scholarly journals O32: TRANSPARENCY IN SURGICAL RANDOMISED CONTROLLED TRIALS: CROSS-SECTIONAL, OBSERVATIONAL STUDY

2021 ◽  
Vol 108 (Supplement_1) ◽  
Author(s):  
JA Helliwell ◽  
B Shelton ◽  
H Mahmood ◽  
R Blanco-Colino ◽  
JE Fitzgerald ◽  
...  
Keyword(s):  
Data Sharing ◽  
Randomised Controlled Trials ◽  
Conflicts Of Interest ◽  
Trial Registration ◽  
Controlled Trials ◽  
Cross Sectional ◽  
Research Waste ◽  
Funding Sources ◽  
Randomised Controlled ◽  
Personal Conflicts Of Interest

Abstract Introduction Randomised controlled trials (RCT) often provide the scientific basis on which commissioning and treatment decisions are made. It is essential that their results and methods are reported transparently. The aim of this study was to explore transparency with respect to trial registration, disclosure of funding sources, conflicts of interest (COI), and data sharing. Method This was a cross-sectional review of surgical RCTs. Data were extracted from RCTs in ten high-impact journals published in the years 2009, 2012, 2015, and 2018. Outcomes of interest were the incidence of reported trial registration, disclosure of funding sources, disclosure of investigator COI, and presence of a statement of data sharing plans. Result A total of 475 were eligible for analysis. Trial registration was present in 73 (67%) studies in 2009, 137 (84%) in 2012, 111 (89%) in 2015 and 110 (93%) in 2018. Funding statements were provided in 55%, 65%, 69.4%, and 75.4% of manuscripts, respectively. Conflicts of interest statements were provided in 49.5%, 89.1%, 94.6%, and 98.3% of manuscripts, respectively. Data sharing statements were present in only 15 (3.2%) RCTs. Eleven of these were in studies published most recently in 2018. Conclusion Trial registration, presence of funding statements, and disclosure of personal conflicts of interest in surgical RCTs have improved rapidly over the last 10 years. In contrast, disclosure of data sharing plans is exceptionally low. This may contribute to research waste and represents an essential target for improvement. Take-home message Trial registration, presence of funding statements, and disclosure of personal conflicts of interest in surgical RCTs have improved rapidly over the last 10 years. In contrast, disclosure of data sharing plans is exceptionally low. This may contribute to research waste and represents an essential target for improvement.

scholarly journals Evaluation of spin in abstracts of papers in psychiatry and psychology journals

2019 ◽  
Vol 25 (5) ◽  
pp. 178-181 ◽  
Author(s):  
Samuel Jellison ◽  
Will Roberts ◽  
Aaron Bowers ◽  
Tyler Combs ◽  
Jason Beaman ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Primary Outcome ◽  
Experimental Treatment ◽  
Controlled Trials ◽  
Industry Funding ◽  
Cross Sectional ◽  
Primary Endpoints ◽  
Nonsignificant Difference ◽  
Randomised Controlled ◽  
The Relationship

We have identified ‘spin’ in abstracts of randomised controlled trials (RCTs) with nonsignificant primary endpoints in psychiatry and psychology journals. This is a cross-sectional review of clinical trials with nonsignificant primary endpoints published in psychiatry and psychology journals from January 2012 to December 2017. The main outcome was the frequency and manifestation of spin in the abstracts. We define spin as the ‘use of specific reporting strategies, from whatever motive, to highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary outcome, or to distract the reader from statistically nonsignificant results’. We have also assessed the relationship between industry funding and spin. Of the 486 RCTs examined, 116 were included in our analysis of spin. Spin was identified in 56% (n=65) of those included. Spin was found in 2 (2%) titles, 24 (21%) abstract results sections and 57 (49.1%) abstract conclusion sections. Evidence of spin was simultaneously identified in both results and conclusions sections in 15% of RCTs (n=17). Twelve articles reported industry funding (10%). Industry funding was not associated with increased odds of spin in the abstract (unadjusted OR: 1.0; 95% CI: 0.3 to 3.2). We found no relationship between industry funding and spin in abstracts. These findings raise concerns about the effects spin may have on clinicians. Further steps could be taken to address spin, including inviting reviewers to comment on the presence of spin and updating Consolidated Standards of Reporting Trials guidelines to contain language discouraging spin.

scholarly journals Understanding current practice, identifying barriers and exploring priorities for adverse event analysis in randomised controlled trials: an online, cross-sectional survey of statisticians from academia and industry

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e036875 ◽  
Author(s):  
Rachel Phillips ◽  
Victoria Cornelius
Keyword(s):  
Adverse Event ◽  
Clinical Research ◽  
Statistical Methods ◽  
Randomised Controlled Trials ◽  
Online Survey ◽  
Research Collaboration ◽  
Controlled Trials ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Randomised Controlled

ObjectivesTo gain a better understanding of current adverse event (AE) analysis practices and the reasons for the lack of use of sophisticated statistical methods for AE data analysis in randomised controlled trials (RCTs), with the aim of identifying priorities and solutions to improve practice.DesignA cross-sectional, online survey of statisticians working in clinical trials, followed up with a workshop of senior statisticians working across the UK.ParticipantsWe aimed to recruit into the survey a minimum of one statistician from each of the 51 UK Clinical Research Collaboration registered clinical trial units (CTUs) and industry statisticians from both pharmaceuticals and clinical research organisations.OutcomesTo gain a better understanding of current AE analysis practices, measure awareness of specialist methods for AE analysis and explore priorities, concerns and barriers when analysing AEs.ResultsThirty-eight (38/51; 75%) CTUs, 5 (5/7; 71%) industry and 21 attendees at the 2019 Promoting Statistical Insights Conference participated in the survey. Of the 64 participants that took part, 46 participants were classified as public sector participants and 18 as industry participants. Participants indicated that they predominantly (80%) rely on subjective comparisons when comparing AEs between treatment groups. Thirty-eight per cent were aware of specialist methods for AE analysis, but only 13% had undertaken such analyses. All participants believed guidance on appropriate AE analysis and 97% thought training specifically for AE analysis is needed. These were both endorsed as solutions by workshop participants.ConclusionsThis research supports our earlier work that identified suboptimal AE analysis practices in RCTs and confirms the underuse of more sophisticated AE analysis approaches. Improvements are needed, and further research in this area is required to identify appropriate statistical methods. This research provides a unanimous call for the development of guidance, as well as training on suitable methods for AE analysis to support change.

scholarly journals Risk of bias and methodological issues in randomised controlled trials of acupuncture for knee osteoarthritis: a cross-sectional study

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e019847 ◽  
Author(s):  
Pengli Jia ◽  
Li Tang ◽  
Jiajie Yu ◽  
Andy H Lee ◽  
Xu Zhou ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Randomised Controlled Trials ◽  
Primary Outcome ◽  
Sample Size Calculation ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Methodological Issues ◽  
Cross Sectional ◽  
Randomised Controlled

ObjectiveTo assess risk of bias and to investigate methodological issues concerning the design, conduct and analysis of randomised controlled trials (RCTs) testing acupuncture for knee osteoarthritis (KOA).MethodsPubMed, EMBASE, Cochrane Central Register of Controlled Trials and four major Chinese databases were searched for RCTs that investigated the effect of acupuncture for KOA. The Cochrane tool was used to examine the risk of bias of eligible RCTs. Their methodological details were examined using a standardised and pilot-tested questionnaire of 48 items, together with the association between four predefined factors and important methodological quality indicators.ResultsA total of 248 RCTs were eligible, of which 39 (15.7%) used computer-generated randomisation sequence. Of the 31 (12.5%) trials that stated the allocation concealment, only one used central randomisation. Twenty-five (10.1%) trials mentioned that their acupuncture procedures were standardised, but only 18 (7.3%) specified how the standardisation was achieved. The great majority of trials (n=233, 94%) stated that blinding was in place, but 204 (87.6%) did not clarify who was blinded. Only 27 (10.9%) trials specified the primary outcome, for which 7 used intention-to-treat analysis. Only 17 (6.9%) trials included details on sample size calculation; none preplanned an interim analysis and associated stopping rule. In total, 46 (18.5%) trials explicitly stated that loss to follow-up occurred, but only 6 (2.4%) provided some information to deal with the issue. No trials prespecified, conducted or reported any subgroup or adjusted analysis for the primary outcome.ConclusionThe overall risk of bias was high among published RCTs testing acupuncture for KOA. Methodological limitations were present in many important aspects of design, conduct and analyses. These findings inform the development of evidence-based methodological guidance for future trials assessing the effect of acupuncture for KOA.

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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