The Effect of Financial Conflict of Interest, Disclosure Status, and Relevance on Medical Research from the United States.

BACKGROUND: Financial interactions between industry and healthcare providers are reportable. Substantial discrepancies have been detected between industry and self-report 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 non-research) influence whether studies report findings favorable to industry sponsors.

Clinical assessment, radiographic imaging, and patient self-report for abdominal wall hernias.

BACKGROUND: Increasingly, abdominal wall hernias are being diagnosed incidentally through radiographic imaging. Such hernias are referred to as occult. However, the clinical significance of occult hernias is unknown. The objective of this study is to determine the prevalence of occult hernias and to assess the abdominal wall quality of life (AW-QOL) among patients with occult hernias. MATERIALS AND METHODS: A blinded, observational, cross-sectional study, October-December 2016, of patients presenting to single academic institution's general surgery clinics was performed. Inclusion criteria included all patients with a computed tomography scan of the abdomen or pelvis within the last year with no intervening abdominal or pelvic surgery. Patients were administered a validated AW-QOL survey and underwent a standardized clinical examination. Computed tomography scans were reviewed. Primary outcomes were prevalence and AW-QOL measured by the modified Activities Assessment Scale. AW-QOL of patients with no hernias was compared to that of those with occult hernias and clinically apparent hernias using Mann-Whitney U test. RESULTS: A total of 250 patients were enrolled of whom 97 (38.8%) had a hernia noted on clinical examination and 132 (52.8%) had a hernia noted on radiographic imaging. The prevalence of occult hernias was 38 (15.2%). Patients with no hernia had a median (interquartile range) AW-QOL of 82.5 (55.0-95.3), patients with clinically apparent hernias had AW-QOL of 47.7 (31.2-81.6; P < 0.001), and patients with occult hernias had AW-QOL of 72.4 (38.5-97.2; P = 0.36). CONCLUSIONS: Both clinically apparent and occult hernias are prevalent. However, only patients with clinically apparent hernias had differences in AW-QOL when compared to patients with no hernias. Prospective trials are needed to assess the outcomes of patients with occult hernias managed with and without surgical repair.

Impact of Abdominal Wall Hernias and Repair on Patient Quality of Life.

BACKGROUND: The modified Activities Assessment Scale (AAS) is a 13-question abdominal wall quality of life (AW-QOL) survey validated in patients undergoing ventral hernia repair (VHR). No studies have assessed AW-QOL among individuals without abdominal wall pathology. The minimal clinically important difference (MCID) of the modified AAS and its implications for the threshold at which VHR should be offered also remain unknown. Our objectives were to (1) establish the AW-QOL of patients with a clinical abdominal wall hernia versus those with no hernia, (2) determine the MCID of the modified AAS, and (3) identify the baseline quality of life (QOL) score at which patients derive little clinical benefit from VHR. METHODS: Patient-centered outcomes data for all patients presenting to General Surgery and Hernia Clinics October-December 2016 at a single safety-net institution were collected via a prospective, cross-sectional observational study design. Primary outcome was QOL measured using the modified AAS. Secondary outcome was the MCID. RESULTS: Patients with no hernia had modified AAS scores of 81.6 (50.4-94.4), while patients with a clinically apparent hernia had lower modified AAS scores of 31.4 (12.6-58.7) (p < 0.001). The MCID threshold was 7.6 for a "slight" change and 14.9 for "definite" change. Above a modified AAS score of 81, the risk of worsening a patient's QOL by surgery is higher than the chances of improvement. CONCLUSIONS: 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.

The Impact of Financial Conflict of Interest on Surgical Research: An Observational Study of Published Manuscripts.

BACKGROUND: Substantial discrepancies exist between industry-reported and self-reported conflicts of interest (COI). Although authors with relevant, self-reported financial COI are more likely to write studies favorable to industry sponsors, it is unknown whether undisclosed COI have the same effect. We hypothesized that surgeons who fail to disclose COI are more likely to publish findings that are favorable to industry than surgeons with no COI. METHODS: PubMed was searched for articles in multiple surgical specialties. Financial COI reported by surgeons and industry were compared. COI were considered to be relevant if they were associated with the product(s) mentioned by an article. Primary outcome was favorability, which was defined as an impression favorable to the product(s) discussed by an article and was determined by 3 independent, blinded clinicians for each article. Primary analysis compared incomplete self-disclosure to no COI. Ordered logistic multivariable regression modeling was used to assess factors associated with favorability. RESULTS: Overall, 337 articles were reviewed. There was a high rate of discordance in the reporting of COI (70.3%). When surgeons failed to disclose COI, their conclusions were significantly more likely to favor industry than surgeons without COI (RR 1.2, 95% CI 1.1-1.4, p < 0.001). On multivariable analysis, any COI (regardless of relevance, disclosure, or monetary amount) were significantly associated with favorability. CONCLUSIONS: 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.

Investigation of Financial Conflict of Interest among Published Ventral Hernia Research.

BACKGROUND: Discordance exists between author self-disclosure and the Open Payments Database in various surgical fields, but the effects of this discordance on study design and presentation are unknown. We hypothesized that, among ventral hernia publications, discordance exists between industry and physician self-reported conflicts of interest (COIs); authors disclose relevant COIs; and disclosure and relevant COIs affect study favorability. STUDY DESIGN: We conducted a double-blinded, prospective, observational study of published articles. PubMed was searched in reverse chronological order for clinical articles pertaining to ventral hernias. Authors' self-disclosed conflicts were compared with those on the Open Payments Database. Two reviewers blinded to article disclosure status determined jointly whether the COIs were relevant to the article. Three blinded referees independently voted whether each article was favorable to discussed subject matter. The primary end point was study favorability. Secondary outcomes included disclosure status and relevance. RESULTS: One hundred articles were included. Compared with authors with no COIs, authors with a COI, self-disclosed or not, were twice as likely to write results favorable to industry. Of those with a COI, most of the articles had a relevant COI (37 of 45 [82.2%]), and 25% of relevant COIs were not disclosed by authors. Among authors with a relevant COI, study favorability remained unchanged at 68.5% (control: no COI 33.3%; p < 0.001). CONCLUSIONS: Within the ventral hernia literature, 70% of articles have a COI. Self-reporting of COI is discordant in 63% of articles. Twenty-five percent of relevant COI are not disclosed. Having a COI increases the chances that an article will cast a favorable impression on the company paying the authors by 200%.