Industry Bias in Randomized Controlled Trials in General and Abdominal Surgery: An Empirical Study
Item Type
Author
Language
English
Abstract
BACKGROUND: Industry sponsorship has been identified as a source of bias in several fields of medical science. To date, the influence of industry sponsorship in the field of general and abdominal surgery has not been evaluated. METHODS: A systematic literature search (1985-2014) was performed in the Cochrane Library, MEDLINE, and EMBASE to identify randomized controlled trials in general and abdominal surgery. Information on funding source, outcome, and methodological quality was extracted. Association of industry sponsorship and positive outcome was expressed as odds ratio (OR) with 95% confidence interval (CI). A χ test and a multivariate logistic regression analysis with study characteristics and known sources of bias were performed. RESULTS: A total of 7934 articles were screened and 165 randomized controlled trials were included. No difference in methodological quality was found. Industry-funded trials more often presented statistically significant results for the primary endpoint (OR, 2.44; CI, 1.04-5.71; P = 0.04). Eighty-eight of 115 (76.5%) industry-funded trials and 19 of 50 (38.0%) non-industry-funded trials reported a positive outcome (OR, 5.32; CI, 2.60-10.88; P < 0.001). Industry-funded trials more often reported a positive outcome without statistical justification (OR, 5.79; CI, 2.13-15.68; P < 0.001). In a multivariate analysis, funding source remained significantly associated with reporting of positive outcome (P < 0.001). CONCLUSIONS: Industry funding of surgical trials leads to exaggerated positive reporting of outcomes. This study emphasizes the necessity for declaration of funding source. Industry involvement in surgical research has to ensure scientific integrity and independence and has to be based on full transparency.
Subject
Humans
Bias
Conflict of Interest
Randomized Controlled Trials as Topic
United States
Industry
Abdomen
Digestive System Surgical Procedures
General Surgery
Publication Title
Publication Year
2016
Publication Date
2016
Journal abreviation
Ann. Surg.
Source
PMID: 26465782PubMed
License
ISSN
1528-1140
Link Attachment
Physical Description
vol. 264, n. 1, pp. 87-92
Short Title
Industry Bias in Randomized Controlled Trials in General and Abdominal Surgery