Evidence map›Paper›PMID 36209914›Full record

SynthesisJournal of clinical epidemiology2022

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

Aileen Liang, Katrina Domenica Cirone, Xiaoxiao Daisy Deng, Merrick Zwarenstein

Abstract readSystematic Review
In one paragraph

Synthesis in Journal of clinical epidemiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Aileen LiangMedical students, Schulich School of Medicine and Dentistry, The University of Western Ontario, London, Ontario, Canada.
Katrina Domenica CironeMedical students, Schulich School of Medicine and Dentistry, The University of Western Ontario, London, Ontario, Canada.
Xiaoxiao Daisy DengMedical students, Schulich School of Medicine and Dentistry, The University of Western Ontario, London, Ontario, Canada.
Merrick ZwarensteinDepartment of Family Medicine, Centre for Studies in Family Medicine, Schulich School of Medicine & Dentistry, The University of Western Ontario, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, The University of Western Ontario, London, Ontario, Canada. Electronic address: merrick.zwarenstein@ices.on.ca.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo explore qualitatively the relationship between selected trial design choices and proxies for a 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 AND

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 centers, single-country or multi-country conduct, dates of initiation and of publication, risk of bias and pragmatism scores, and also on an impact measured by citation in scientific literature and in clinical guidelines. We qualitatively compared design features of the highest impact vs. other trials.

resultsRandomised Evaluation of COVID-19 Therapy (RECOVERY) 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, multicentre 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 centers, and more rapid recruitment resulting in a larger sample size and early publication.

conclusionHigher pragmatism scores may contribute to recruiting more centers and more rapid recruitment of patients at each center, 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.

Indexed as

Adrenal Cortex HormonesCOVID-19Randomized Controlled Trials as TopicAdaptive Clinical Trials as TopicHumansAdrenal Cortex HormonesCorticosteroidsCOVID-19Pragmatic TrialPRECIS-2Randomized controlled trial

Identifiers

PMID36209914
PMCPMC9536028

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.