Authors:	Stoll, Marlene Lindner, Saskia Marquard, Bernd Salholz‑Hillel, Maia DeVito, Nicholas J. Klemperer, David Lieb, Klaus
Title:	Completeness and consistency of primary outcome reporting in COVID-19 publications in the early pandemic phase : a descriptive study
Online publication date:	12-Dec-2023
Year of first publication:	2023
Language:	english
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.
DDC:	150 Psychologie 150 Psychology 610 Medizin 610 Medical sciences
Institution:	Johannes Gutenberg-Universität Mainz
Department:	FB 02 Sozialwiss., Medien u. Sport
Place:	Mainz
ROR:	https://ror.org/023b0x485
DOI:	http://doi.org/10.25358/openscience-9718
Version:	Published version
Publication type:	Zeitschriftenaufsatz
Document type specification:	Scientific article
License:	CC BY
Information on rights of use:	https://creativecommons.org/licenses/by/4.0/
Journal:	BMC medical research methodology 23
Pages or article number:	173
Publisher:	Springer Nature
Publisher place:	London
Issue date:	2023
ISSN:	1471-2288
Publisher DOI:	10.1186/s12874-023-01991-9
Appears in collections:	DFG-491381577-G