Redmond, Shelagh; von Elm, Erik; Blümle, Anette; Gengler, Malou; Gsponer, Thomas; Egger, Matthias (2013). Cohort study of trials submitted to ethics committee identified discrepant reporting of outcomes in publications. Journal of clinical epidemiology, 66(12), pp. 1367-1375. New York, N.Y.: Elsevier 10.1016/j.jclinepi.2013.06.020
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OBJECTIVES
To identify factors associated with discrepant outcome reporting in randomized drug trials.
STUDY DESIGN AND SETTING
Cohort study of protocols submitted to a Swiss ethics committee 1988-1998: 227 protocols and amendments were compared with 333 matching articles published during 1990-2008. Discrepant reporting was defined as addition, omission, or reclassification of outcomes.
RESULTS
Overall, 870 of 2,966 unique outcomes were reported discrepantly (29.3%). Among protocol-defined primary outcomes, 6.9% were not reported (19 of 274), whereas 10.4% of reported outcomes (30 of 288) were not defined in the protocol. Corresponding percentages for secondary outcomes were 19.0% (284 of 1,495) and 14.1% (334 of 2,375). Discrepant reporting was more likely if P values were <0.05 compared with P ≥ 0.05 [adjusted odds ratio (aOR): 1.38; 95% confidence interval (CI): 1.07, 1.78], more likely for efficacy compared with harm outcomes (aOR: 2.99; 95% CI: 2.08, 4.30) and more likely for composite than for single outcomes (aOR: 1.48; 95% CI: 1.00, 2.20). Cardiology (aOR: 2.34; 95% CI: 1.44, 3.79) and infectious diseases (aOR: 1.77; 95% CI: 1.01, 3.13) had more discrepancies compared with all specialties combined.
CONCLUSION
Discrepant reporting was associated with statistical significance of results, type of outcome, and specialty area. Trial protocols should be made freely available, and the publications should describe and justify any changes made to protocol-defined outcomes.
Item Type: |
Journal Article (Original Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine (ISPM) |
UniBE Contributor: |
Redmond, Shelagh, Gsponer, Thomas, Egger, Matthias |
Subjects: |
600 Technology > 610 Medicine & health 300 Social sciences, sociology & anthropology > 360 Social problems & social services |
ISSN: |
0895-4356 |
Publisher: |
Elsevier |
Language: |
English |
Submitter: |
Doris Kopp Heim |
Date Deposited: |
12 Dec 2013 16:00 |
Last Modified: |
05 Dec 2022 14:26 |
Publisher DOI: |
10.1016/j.jclinepi.2013.06.020 |
PubMed ID: |
24075598 |
Uncontrolled Keywords: |
Drug industry Ethics committee Publication bias Randomized controlled trial Statistics and numerical data Treatment outcome |
BORIS DOI: |
10.7892/boris.39005 |
URI: |
https://boris.unibe.ch/id/eprint/39005 |
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