BACKGROUND: Financial interactions between industry and healthcare providers are reportable. Substantial discrepancies have been detected between industry and selfreport of these conflicts of interest (COIs). OBJECTIVE: Our aim was to determine if authors who fail to disclose reportable COI are more likely to publish findings that are favorable to industry than authors with no COI. DESIGN: In this blinded, observational study of medical and surgical primary research articles in PubMed, 590 articles were reviewed. MAIN MEASURES: Reportable financial relationships between authors and industry were evaluated. COIs were considered to have relevance if they were associated with the product(s) mentioned by an article. Primary outcome was favorability, defined as an impression favorable to the product(s) discussed by an article and determined by 3 independent, blinded clinicians for each article. Primary analysis compared Incomplete Self-Disclosure to No COI. Two-level multivariable mixed-effects ordered logistic regression was used to assess factors associated with favorability. KEY RESULTS: A 69% discordance rate existed between industry and self-report in COI disclosure. When authors failed to disclose COI, their conclusions were more likely to favor industry partners than authors without COI (favorable ratings 73% versus 62%, RR 1.18, p = < 0.001). On univariate (any COI 74% versus no COI 62%, RR 1.11, p = < 0.001) and multivariable analyses, any COI was associated with favorability. CONCLUSIONS: All financial COIs (disclosed or undisclosed, relevant or not relevant, research or nonresearch) influence whether studies report findings favorable to industry sponsors.
BACKGROUND
The Open Payments Database (OPD) discloses financial transactions between manufacturers and physicians. The concordance of OPD- versus self-reported COI is unknown.
MATERIALS AND METHODS
Our objectives were to compare 1) industry and self-disclosed COI in clinical literature, 2) payments within each disclosure level, and 3) industry- and self-disclosed COI and payments by specialty. This was an observational study. PubMed was searched for clinical studies accepted for publication from 1/2014 to 6/2016. Author and OPD-disclosed COI were compared. Articles and authors were divided into Full Disclosure; Incomplete Industry Disclosure; Incomplete Self-Disclosure; and No COI. Primary outcome (differences in reported COI per manuscript) was assessed using McNemar’s test. Payment differences were compared using Kruskal-Wallis Test.
RESULTS
OPD- and self-disclosed COI differed (65.0% discordance rate by manuscript, p<0.001). Percentages of authors within each disclosure category differed between specialties (p<0.001). Hematology manuscripts exhibited the highest discordance rate (79.0%) and received the highest median payment for Incomplete Self-Disclosure ($30,812).
CONCLUSIONS
Significant discordance exists between self- and OPD-reported COI. Additional research is needed to determine reasons for these differences.
VHR can improve 1-year postsurgical AW-QOL to levels similar to that of the general population. The MCID of the modified AAS is 7.6 points. Patients with high baseline scores should be counseled about the lack of potential benefit in QOL from elective VHR.
Any financial COI (disclosed or undisclosed, relevant or not relevant) significantly influence whether studies report findings favorable to industry. More attention must be paid to improving research design, maximizing transparency in medical research, and insisting that surgeons disclose all COI, regardless of perceived relevance.
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