Completeness and consistency of primary outcome reporting in COVID-19 publications in the early pandemic phase: a descriptive study

Marlene Stoll; Saskia Lindner; Bernd Marquardt; Maia Salholz-Hillel; Nicholas J DeVito; David Klemperer; Klaus Lieb

doi:10.1186/s12874-023-01991-9

Completeness and consistency of primary outcome reporting in COVID-19 publications in the early pandemic phase: a descriptive study

BMC Med Res Methodol. 2023 Jul 29;23(1):173. doi: 10.1186/s12874-023-01991-9.

Authors

Marlene Stoll^{1

2}, Saskia Lindner³, Bernd Marquardt³, Maia Salholz-Hillel⁴, Nicholas J DeVito⁵, David Klemperer⁶, Klaus Lieb^{3

7}

Affiliations

¹ Department of Psychiatry and Psychotherapy, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany. ms@leibniz-psychology.org.
² Leibniz Institute for Resilience Research (LIR), Mainz, Germany. ms@leibniz-psychology.org.
³ Department of Psychiatry and Psychotherapy, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.
⁴ QUEST Center for Responsible Research, Berlin Institute of Health (BIH), Charité Universitätsmedizin Berlin, Berlin, Germany.
⁵ Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
⁶ Ostbayrische Technische Hochschule Regensburg, Regensburg, Germany.
⁷ Leibniz Institute for Resilience Research (LIR), Mainz, Germany.

Abstract

Background: The COVID-19 pandemic saw a steep increase in the number of rapidly published scientific studies, especially early in the pandemic. Some have suggested COVID-19 trial reporting is of lower quality than typical reports, but there is limited evidence for this in terms of primary outcome reporting. The objective of this study was to assess the prevalence of completely defined primary outcomes reported in registry entries, preprints, and journal articles, and to assess consistent primary outcome reporting between these sources.

Methods: This is a descriptive study of a cohort of registered interventional clinical trials for the treatment and prevention of COVID-19, drawn from the DIssemination of REgistered COVID-19 Clinical Trials (DIRECCT) study dataset. The main outcomes are: 1) Prevalence of complete primary outcome reporting; 2) Prevalence of consistent primary outcome reporting between registry entry and preprint as well as registry entry and journal article pairs.

Results: We analyzed 87 trials with 116 corresponding publications (87 registry entries, 53 preprints and 63 journal articles). All primary outcomes were completely defined in 47/87 (54%) registry entries, 31/53 (58%) preprints and 44/63 (70%) journal articles. All primary outcomes were consistently reported in 13/53 (25%) registry-preprint pairs and 27/63 (43%) registry-journal article pairs. No primary outcome was specified in 13/53 (25%) preprints and 8/63 (13%) journal articles. In this sample, complete primary outcome reporting occurred more frequently in trials with vs. without involvement of pharmaceutical companies (76% vs. 45%), and in RCTs vs. other study designs (68% vs. 49%). The same pattern was observed for consistent primary outcome reporting (with vs. without pharma: 56% vs. 12%, RCT vs. other: 43% vs. 22%).

Conclusions: In COVID-19 trials in the early phase of the pandemic, all primary outcomes were completely defined in 54%, 58%, and 70% of registry entries, preprints and journal articles, respectively. Only 25% of preprints and 43% of journal articles reported primary outcomes consistent with registry entries.

Keywords: COVID-19; Discrepancy; Methodological quality; Primary outcome; Reporting quality; Trial registry.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

COVID-19* / epidemiology
Humans
Pandemics
Registries
Research Design