To quantify the influence of financial conflict of interest (COI) payments on the reporting of clinical results for robotic surgery.
A systematic search (Ovid MEDLINE databases) was conducted (May 2017) to identify randomized controlled trials (RCTs) and observational studies comparing the efficacy of the da Vinci robot on clinical outcomes. Financial COI data for authors (per study) were determined using open payments database.
Primary outcomes assessed were receipt of financial COI payments and overall conclusion reported between robotic versus comparative approach. Quality/risk of bias was assessed using Newcastle-Ottawa Scale (NOS)/Cochrane risk of bias tool. Disclosure discrepancies were also analyzed.
Study characteristics, surgical subspecialty, methodological assessment, reporting of disclosure statements, and study findings dual abstracted. The association of the amount of financial support received as a predictor of reporting positive findings associated robotic surgery was assessed at various cut-offs of dollar amount received by receiver operating curve (ROC).
Thirty-three studies were included, 9 RCTs and 24 observational studies. There was a median, 111 patients (range 10 to 6420) across studies. A little more than half (17/33) had a conclusion statement reporting positive results in support of robotic surgery, with 48% (16/33) reporting results not in favor [equivocal: 12/33 (36%), negative: 4/33 (12%)]. Nearly all (91%) studies had authors who received financial COI payments, with a median of $3364.46 per study (range $9 to $1,775,378.03). ROC curve demonstrated that studies receiving greater than $9557.31 (cutpoint) were more likely to report positive robotic surgery results (sensitivity: 0.65, specificity: 0.81, area under the curve: 0.73). Studies with financial COI payment greater than this amount were more likely to report beneficial outcomes with robotic surgery [(78.57% vs 31.58%, P = 0.013) with an odds ratio of 2.07 (confidence interval: 0.47–3.67; P = 0.011)]. Overall, studies were high quality/low risk of bias [median NOS: 8 (range 5 to 9)]; Cochrane risk: “low risk” (9/9, 100%)].
Financial COI sponsorship appears to be associated with a higher likelihood of studies reporting a benefit of robotic surgery. Our findings suggest a dollar amount where financial payments influence reported clinical results, a concept that challenges the current guidelines, which do not account for the amount of COI funding received.
*Center for Healthcare Outcomes & Policy, University of Michigan, Ann Arbor, MI
†Section of Pediatric Surgery, C.S. Mott Children's Hospital, Ann Arbor, MI
‡Taubman Health Sciences Library, University of Michigan, Ann Arbor, MI
§Department of Surgery, Michigan Medicine, Ann Arbor, MI
¶Department of Surgery, David Geffen School of Medicine at UCLA, Los Angeles, CA.
Reprints: Samir K. Gadepalli, MD, MBA, 1540 E. Hospital Drive. Ann Arbor, MI 48109. E-mail: email@example.com.
Study conception and design: Criss, Gadepalli, Maggard, MacEachern, Dimick.
Acquisition of data: Criss, Gadepalli, MacEachern.
Analysis and interpretation of data: Criss, Gadepalli, Maggard, Matusko, MacEachern.
Drafting of manuscript: Criss, Gadepalli, Maggard, Dimick, Matusko.
Critical revision: Criss, Gadepalli, Dimick, Maggard, MacEachern.
No patients were enrolled or evaluated in this study, so ethics approval was not obtained.
Authors received no support from any organization for the submitted work; Cory Criss has previously published research and video presentations on the FlexDex, a potential competitor of Intuitive Surgical, Inc. However, he does not receive any financial support, including grant support, salary support, or donated equipment for the work with FlexDex. He did perform an analysis of the instrument, during which time he used instruments from FlexDex. However, after the study conclusion, the instruments were returned. Additional authors have no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years, with no other relationships or activities that could appear to have influenced the submitted work.
No funding was used for this study.
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