Cited by 9Academic Publishing and Open AccessMeta-analysis and systematic reviewsCOVID-19 Clinical Research Studies

Comparison of effect estimates between preprints and peer-reviewed journal articles of COVID-19 trials

Open access
Davidson, Mauricia, Evrenoglou, Theodoros, Graña, Carolina, Chaimani, Anna, Boutron, Isabelle·2024·BMC Medical Research Methodology

Abstract

Background: Preprints are increasingly used to disseminate research results, providing multiple sources of information for the same study. We assessed the consistency in effect estimates between preprint and subsequent journal article of COVID-19 randomized controlled trials. Methods: The study utilized data from the COVID-NMA living systematic review of pharmacological treatments for COVID-19 (covid-nma.com) up to July 20, 2022. We identified randomized controlled trials (RCTs) evaluating pharmacological treatments vs. standard of care/placebo for patients with COVID-19 that were originally posted as preprints and subsequently published as journal articles. Trials that did not report the same analysis in both documents were excluded. Data were extracted independently by pairs of researchers with consensus to resolve disagreements. Effect estimates extracted from the first preprint were compared to effect estimates from the journal article. Results: The search identified 135 RCTs originally posted as a preprint and subsequently published as a journal article. We excluded 26 RCTs that did not meet the eligibility criteria, of which 13 RCTs reported an interim analysis in the preprint and a final analysis in the journal article. Overall, 109 preprint–article RCTs were included in the analysis. The median (interquartile range) delay between preprint and journal article was 121 (73–187) days, the median sample size was 150 (71–464) participants, 76% of RCTs had been prospectively registered, 60% received industry or mixed funding, 72% were multicentric trials. The overall risk of bias was rated as ‘some concern’ for 80% of RCTs. We found that 81 preprint–article pairs of RCTs were consistent for all outcomes reported. There were nine RCTs with at least one outcome with a discrepancy in the number of participants with outcome events or the number of participants analyzed, which yielded a minor change in the estimate of the effect. Furthermore, six RCTs had at least one outcome missing in the journal article and 14 RCTs had at least one outcome added in the journal article compared to the preprint. There was a change in the direction of effect in one RCT. No changes in statistical significance or conclusions were found. Conclusions: Effect estimates were generally consistent between COVID-19 preprints and subsequent journal articles. The main results and interpretation did not change in any trial. Nevertheless, some outcomes were added and deleted in some journal articles.

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Authors
Davidson, M., Evrenoglou, T., Graña, C., Chaimani, A., & Boutron, I.
Affiliations
Inserm (FR)
Corresponding author
Davidson, Mauricia
Venue
BMC Medical Research Methodology
Published
2024-01-11
Volume
24
Issue
1
Pages
9-9
ISSN
1471-2288 (ISSN-L)
OpenAlex
W4390751452
Cited by
9
References
31
Citations by year
2026: 1 · 2025: 4 · 2024: 4
FWCI
3.36
Type
journal article
Language
en
Open access
Locations
  • BMC Medical Research Methodology (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • HAL (submittedVersion, cc-by)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
Institut National de la Santé et de la Recherche Médicale
Topics
  • Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
Keywords
preprints, COVID-19 pandemic, randomized controlled trials, effect estimates, pharmacotherapy, reporting discrepancies, outcome reporting, research dissemination, risk of bias, clinical trial registration, funding disclosure, interim analysis, time to publication, research integrity, reproducibility
MeSH terms
Preprints as Topic, Systematic Reviews as Topic, COVID-19, Humans, Bias, Randomized Controlled Trials as Topic, Publication Bias, Peer Review, Research

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