Association of Trial Registration With Reporting of Primary Outcomes in Protocols and Publications
Open accessAbstract
This study characterizes discrepancies between primary outcomes specified in trial protocols, registrations, and publications, and the association between prospective registration and consistency of published outcomes.
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Documentation of a trial's existence and prespecified outcomes in a publicly accessible registry helps increase transparency, decrease unnecessary duplication of research effort, facilitate identification of ongoing trials for prospective participants, and identify and deter selective reporting of study results.
“Documentation of a trial’s existence and prespecified outcomes in a publicly accessible registry helps to increase transparency, decrease unnecessary duplication of research effort, facilitate identification of ongoing trials for prospective participants, and identify and deter selective reporting of study results.63 64”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [63]
Prespecifying the analysis plans in the protocol reduces the risk of selective reporting of outcomes and results.
“Prespecifying the analysis plans in the protocol reduces the risk of selective reporting of outcomes and results.63 64 81 82”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [63]
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References 6 · Cited by 78
- Authors
- Chan, A.-W., Pello, A., Kitchen, J., Axentiev, A., Virtanen, J. I., Liu, A., & Hemminki, E.
- Affiliations
- University of Toronto (CA)
- University of Helsinki (FI)
- University of Oulu (FI)
- Finnish Institute for Health and Welfare (FI)
- Corresponding author
- Chan, An-Wen
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2017-11-07
- Volume
- 318
- Issue
- 17
- Pages
- 1709
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC5818784
- OpenAlex
- W2750929662
- Cited by
- 78
- References
- 6
- Citations by year
- 2026: 2 · 2025: 14 · 2024: 6 · 2023: 7 · 2022: 3 · 2021: 8 · 2020: 13 · 2019: 15 · 2018: 10
- FWCI
- 9.30
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- JAMA (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- WOS
- Funders
- Canadian Institutes of Health Research
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
- Keywords
- clinical trial registration, primary outcome reporting, reporting consistency, prospective registration, trial reporting quality
- MeSH terms
- Clinical Protocols, Clinical Trials as Topic, Finland, Humans, Registries, Research Design, Cohort Studies, Logistic Models
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