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Pilot trials in physical activity journals: a review of reporting and editorial policy.

ABSTRACT: Background:Since the early 2000s, a number of publications in the medical literature have highlighted inadequacies in the design, conduct and reporting of pilot trials. This work led to two notable publications in 2016: a conceptual framework for defining feasibility studies and an extension to the CONSORT 2010 statement to include pilot trials. It was hoped that these publications would educate researchers, leading to better use of pilot trials and thus more rigorously planned and informed randomised controlled trials. The aim of the present work is to evaluate the impact of these publications in the field of physical activity by reviewing the literature pre- and post-2016. This first article presents the pre-2016 review of the reporting and the current editorial policy applied to pilot trials published in physical activity journals. Methods:Fourteen physical activity journals were screened for pilot and feasibility studies published between 2012 and 2015. The CONSORT 2010 extension to pilot and feasibility studies was used as a framework to assess the reporting quality of the studies. Editors of the eligible physical activity journals were canvassed regarding their editorial policy for pilot and feasibility studies. Results:Thirty-one articles across five journals met the eligibility criteria. These articles fell into three distinct categories: trials that were carried out in preparation for a future definitive trial (23%), trials that evaluated the feasibility of a novel intervention but did not explicitly address a future definitive trial (23%) and trials that did not have any clear objectives to address feasibility (55%). Editors from all five journals stated that they generally do not accept pilot trials, and none gave reference to the CONSORT 2010 extension as a guideline for submissions. Conclusion:The result that over half of the studies did not have feasibility objectives is in line with previous research findings, demonstrating that these findings are not being disseminated effectively to researchers in the field of physical activity. The low standard of reporting across most reviewed articles and the neglect of the extended CONSORT 2010 statement by the journal editors highlight the need to actively disseminate these guidelines to ensure their impact.

SUBMITTER: Horne E

PROVIDER: S-EPMC6048748 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Pilot trials in physical activity journals: a review of reporting and editorial policy.

Horne Elsie E Lancaster Gillian A GA Matson Rhys R Cooper Ashley A Ness Andy A Leary Sam S

Pilot and feasibility studies 20180717

<h4>Background</h4>Since the early 2000s, a number of publications in the medical literature have highlighted inadequacies in the design, conduct and reporting of pilot trials. This work led to two notable publications in 2016: a conceptual framework for defining feasibility studies and an extension to the CONSORT 2010 statement to include pilot trials. It was hoped that these publications would educate researchers, leading to better use of pilot trials and thus more rigorously planned and infor ...[more]

PMID: 30026962

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Project description:ObjectivesTo assess how often stratified randomisation is used, whether analysis adjusted for all balancing variables, and whether the method of randomisation was adequately reported, and to reanalyse a previously reported trial to assess the impact of ignoring balancing factors in the analysis.DesignReview of published trials and reanalysis of a previously reported trial.SettingFour leading general medical journals (BMJ, Journal of the American Medical Association, Lancet, and New England Journal of Medicine) and the second Multicenter Intrapleural Sepsis Trial (MIST2).Participants258 trials published in 2010 in the four journals. Cluster randomised, crossover, non-randomised, single arm, and phase I or II trials were excluded, as were trials reporting secondary analyses, interim analyses, or results that had been previously published in 2010.Main outcome measuresWhether the method of randomisation was adequately reported, how often balanced randomisation was used, and whether balancing factors were adjusted for in the analysis.ResultsReanalysis of MIST2 showed that an unadjusted analysis led to larger P values and a loss of power. The review of published trials showed that balanced randomisation was common, with 163 trials (63%) using at least one balancing variable. The most common methods of balancing were stratified permuted blocks (n=85) and minimisation (n=27). The method of randomisation was unclear in 37% of trials. Most trials that balanced on centre or prognostic factors were not adequately analysed; only 26% of trials adjusted for all balancing factors in their primary analysis. Trials that did not adjust for balancing factors in their analysis were less likely to show a statistically significant result (unadjusted 57% v adjusted 78%, P=0.02).ConclusionBalancing on centre or prognostic factors is common in trials but often poorly described, and the implications of balancing are poorly understood. Trialists should adjust their primary analysis for balancing factors to obtain correct P values and confidence intervals and to avoid an unnecessary loss in power.

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Pilot trials in physical activity journals: a review of reporting and editorial policy.

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Pilot trials in physical activity journals: a review of reporting and editorial policy.

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