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The relationship between pragmatism, timing, and study size on impact of treatment trials: a qualitative, hypothesis generating study of systemic corticosteroids for COVID-19
The relationship between pragmatism, timing, and study size on impact of treatment trials: a qualitative, hypothesis generating study of systemic corticosteroids for COVID-19
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The relationship between pragmatism, timing, and study size on impact of treatment trials: a qualitative, hypothesis generating study of systemic corticosteroids for COVID-19
The relationship between pragmatism, timing, and study size on impact of treatment trials: a qualitative, hypothesis generating study of systemic corticosteroids for COVID-19

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The relationship between pragmatism, timing, and study size on impact of treatment trials: a qualitative, hypothesis generating study of systemic corticosteroids for COVID-19
The relationship between pragmatism, timing, and study size on impact of treatment trials: a qualitative, hypothesis generating study of systemic corticosteroids for COVID-19
Journal Article

The relationship between pragmatism, timing, and study size on impact of treatment trials: a qualitative, hypothesis generating study of systemic corticosteroids for COVID-19

2022
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Overview
AbstractObjectiveTo explore qualitatively the relationship between selected trial design choices and proxies for scientific and clinical uptake in a cohort of published randomized controlled trials (RCTs) of corticosteroids for COVID-19, to identify design characteristics that may result in trials with potential to eliminate equipoise, achieve uptake and help reduce research waste. Study Design & SettingA systematic literature search and qualitative, narrative review of published RCTs (up to April 13, 2021) evaluating the effectiveness of systemic corticosteroids in treatment of COVID-19. We extracted information on sample size, number of centres, single or multi-country conduct, dates of initiation and of publication, risk of bias and pragmatism scores, and also on impact measured by citation in scientific literature and in clinical guidelines. We qualitatively compared design features of the highest impact versus other trials. ResultsRECOVERY was by the most impactful of the seven eligible RCTs as it was 10 times more frequently cited in peer-reviewed literature and influenced all the selected COVID-19 treatment guidelines. All trials started recruiting from similar dates. RECOVERY was a single country, multi-centre platform trial at low risk of bias, features which also fail to distinguish it from the other trials. RECOVERY was distinguished by more strongly pragmatic design features, more centres, and more rapid recruitment resulting in a larger sample size, and early publication. ConclusionHigher pragmatism scores may contribute to recruiting more centres and more rapid recruitment of patients at each centre, leading to larger size, earlier publication, and greater scientific and guideline uptake. By eliminating equipoise RECOVERY rendered other simultaneous trials redundant. Further work is needed to confirm these findings in a larger quantitative study and to identify the individual contribution of each characteristic of pragmatism to conduct and impact of trials, and their interaction in different national contexts. Until then research waste might be reduced by designing trials with as many of the characteristics of RECOVERY as is feasible.
Publisher
Published by Elsevier Inc