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The majority of observational studies in leading peer-reviewed medicine journals are not registered and do not have a publicly accessible protocol: a scoping review

Leducq, Sophie; Zaki, Faaris; Hollestein, Loes M.; Apfelbacher, Christian; Ponna, Nikhil Prasanna; Mazmudar, Rishabh; Gran, Sonia

The majority of observational studies in leading peer-reviewed medicine journals are not registered and do not have a publicly accessible protocol: a scoping review Thumbnail


Authors

Sophie Leducq

Faaris Zaki

Loes M. Hollestein

Christian Apfelbacher

Nikhil Prasanna Ponna

Rishabh Mazmudar

SONIA GRAN SONIA.GRAN@NOTTINGHAM.AC.UK
Associate Professor



Abstract

Objectives
Observational studies are not subject to the same requirements as randomized controlled trials, such as registration or publishing a protocol. The aim of this scoping review was to estimate the registration rate of observational studies in leading peer-reviewed medicine journals and to evaluate whether protocols were available in the public domain.
Study Design and Setting
In March 2023, we searched OVID Medline for observational studies published in 2022 in the top five general medicine journals according to impact factor (The Lancet, The British Medical Journal (BMJ), The Journal of the American Medical Association, The New England Journal of Medicine, and Annals of Internal Medicine). We defined an observational study as a cohort study, a case-control study, a cross-sectional study, or a case series. Information on i) the proportion of observational studies that have been registered and ii) the proportion of observational studies that have a protocol available in the public domain was extracted from a random sample of studies.
Results
Our search identified 699 studies; 290 studies were selected as full text, and a random sample of 200 studies was included. For half of the studies, the first author worked at a US institution. Most studies were cohort studies (n = 126, 63.0%) and used administrative healthcare records, electronic healthcare records, and registries. Of the 200 observational studies, 20 (10.0%) were registered. Among those, 14 were prospectively registered. Twenty-four studies (12.0%) had a protocol available in the public domain. Studies that were registered or had a protocol, were more frequently published in the BMJ (n = 12/28, 42.9%), had a first author working in the UK (n = 10/28, 35.7%) and used electronic health care records (n = 13/28, 46.4%) compared to studies with no registration and no protocol.
Conclusion
The rate of prospectively registered observational studies is worryingly low. Prospective registration of observational studies should be encouraged and standardized to ensure transparency in clinical research and reduce research waste.

Citation

Leducq, S., Zaki, F., Hollestein, L. M., Apfelbacher, C., Ponna, N. P., Mazmudar, R., & Gran, S. (2024). The majority of observational studies in leading peer-reviewed medicine journals are not registered and do not have a publicly accessible protocol: a scoping review. Journal of Clinical Epidemiology, 170, Article 111341. https://doi.org/10.1016/j.jclinepi.2024.111341

Journal Article Type Article
Acceptance Date Mar 25, 2024
Online Publication Date Mar 29, 2024
Publication Date 2024-06
Deposit Date Jun 18, 2024
Publicly Available Date Jun 19, 2024
Journal Journal of Clinical Epidemiology
Print ISSN 0895-4356
Electronic ISSN 1878-5921
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 170
Article Number 111341
DOI https://doi.org/10.1016/j.jclinepi.2024.111341
Public URL https://nottingham-repository.worktribe.com/output/33549021
Publisher URL https://www.jclinepi.com/article/S0895-4356(24)00096-9/fulltext
Related Public URLs https://www.sciencedirect.com/science/article/pii/S0895435624000969

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