Cohort study of trials submitted to ethics committee identified discrepant reporting of outcomes in publications.

Details

Serval ID
serval:BIB_7C389C95F1F8
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Cohort study of trials submitted to ethics committee identified discrepant reporting of outcomes in publications.
Journal
Journal of Clinical Epidemiology
Author(s)
Redmond S., von Elm E., Blümle A., Gengler M., Gsponer T., Egger M.
ISSN
1878-5921 (Electronic)
ISSN-L
0895-4356
Publication state
Published
Issued date
2013
Volume
66
Number
12
Pages
1367-1375
Language
english
Notes
Publication types: Journal ArticlePublication Status: ppublish
Abstract
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.
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Web of science
Create date
15/12/2013 15:47
Last modification date
20/08/2019 14:37
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