Discrepancies in Financial Conflicts of Interest in Robotic Cardiothoracic Surgery Studies.

BACKGROUND: In academic surgery publications, self-reporting of conflicts of interest (COI) has often proved to be inaccurate. Here, we review the accuracy of COI disclosures for studies related to the use of robotic technology in cardiothoracic surgery and evaluate factors associated with increased discrepancies. METHODS: A literature search identified robotic surgery-related studies with at least 1 American author published between January 2015 and December 2020 from 3 major American cardiothoracic surgery journals (The Journal of Thoracic and Cardiovascular Surgery, The Annals of Thoracic Surgery, and Annals of Cardiothoracic Surgery). Industry payments from Intuitive Surgical (Intuitive) were collected with use of the Centers for Medicare and Medicaid Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and the year prior (24-month period). RESULTS: A total of 144 studies (764 authors) were identified. At least 1 author of 112 studies (78%) had received payments from Intuitive. At least 1 author of 98 studies (68%) had received an undeclared payment from Intuitive. Authors who accurately disclosed payments received significantly higher median payments compared with authors who did not ($16,511 [interquartile range, $6389-$159,035] vs $1762 [interquartile range, $338-$7500]; P < .0001). Last authors were significantly more likely to have a COI discrepancy compared with middle and first authors (P = .018; P = .0015). CONCLUSIONS: Most studies investigating the use of robotic technology in cardiothoracic surgery did not accurately declare COI with Intuitive. This study highlights the need for improved accuracy of reporting industry sponsorship by publishing authors.

A Cost-Utility Analysis of the Use of Closed-Incision Negative Pressure System in Vascular Surgery Groin Incisions.

OBJECTIVE: Closed-incision negative pressure therapy (CINPT) with the Prevena system has been used and clinically evaluated in high-risk groin incisions to reduce the risk of postoperative complications. We performed a cost-effectiveness analysis evaluating CINPT in femoral-popliteal bypass with prosthetic graft. METHODS: A literature review looking at prospective randomized trials determined the probabilities and outcomes for femoral-popliteal bypass with and without CINPT. Reported utility scores were used to estimate the quality adjusted life years (QALYs) associated with a successful procedure and postoperative complications. Medicare current procedure terminology and diagnosis-related group codes were used to assess the costs for a successful surgery and associated complications. A decision analysis tree was constructed with rollback analysis to highlight the more cost-effective strategy. An incremental cost-effectiveness ratio (ICER) analysis was performed with a willingness to pay at $50,000. Deterministic and probabilistic sensitivity analyses were performed to validate the robustness of the results, and to accommodate for the uncertainty in the literature. RESULTS: Femoral-popliteal bypass with CINPT is less costly ($40,138 vs $41,774) and more effective (6.14 vs 6.13) compared to without CINPT. This resulted in a negative ICER of -234,764.03, which favored CINPT, indicating a dominant strategy. In one-way sensitivity analysis, surgery without CINPT was more cost-effective if the probability of successful surgery falls below 84.9% or if the cost of CINPT exceeds $3139. Monte Carlo analysis showed a confidence of 99.07% that CINPT is more cost-effective. CONCLUSIONS: Despite the added device cost of CINPT, it is cost-effective in vascular surgical operations using groin incisions.

Assessment of Financial Conflicts of Interest Related to the Use of Dermal Substitutes in Burn Management.

This study aims to systematically review the accuracy of the self-reporting of conflicts of interest (COIs) among studies related to the use of dermal substitute products in burn management and evaluate factors associated with increased discrepancies. To do so, a literature search was done to identify studies investigating the use of dermal substitutes in burn management published between 2015 and 2019. Industry payments were collected using the Centers for Medicare and Medicaid Services Open Payments database. Declared COIs were then compared with the listed payments. Studies and authors were considered to have a COI if they received payments totaling more than $100 for each company. A total of 51 studies (322 authors) were included for analysis. Forty studies and 104 authors received at least one payment from the industry. Of these studies, 38 (95%) studies and 91 (88%) authors were found to have a COI discrepancy. From 2015 to 2019, 1391 general payments (totaling $1,696,848) and 108 research payments (totaling $1,849,537) were made by 82 companies. When increasing the threshold on what would be considered an undisclosed payment, the proportion of authors with discrepancies gradually decreased, from 88% of authors with undisclosed payments more than $100 to 27% of authors with undisclosed payments more than $10,000. Author order, journal impact factor, and study type were not significantly associated with increased risk of discrepancy. We found that the majority of studies investigating the use of dermal substitute products for burn management did not accurately declare COI, highlighting the need for a uniform declaration process and greater transparency of industry sponsorship by authors when publishing peer-reviewed burn surgery research papers.

Conflicts of Interest in Studies Related to Mesh Use in Ventral Hernia Repair and Abdominal Wall Reconstruction.

OBJECTIVE: To examine the accuracy of the reporting of conflicts of interest (COI) among studies related to mesh use in ventral hernia repair and abdominal wall reconstruction. SUMMARY BACKGROUND DATA: Accurate declaration of COI is integral to ensuring transparency of study results. Multiple studies have demonstrated undeclared COI are prevalent in surgical literature. METHODS: Studies with at least 1 American author accepted between 2014 and 2018 in 12 major, peer-reviewed general surgery and plastic surgery journals were included. Declared COI were compared with payments listed in the "Open Payments" database [maintained by the Centers for Medicare & Medicaid Services (CMS)] during the year of acceptance and 1 year prior. Studies and authors were considered to have a COI if they received payments from any of 8 major mesh companies totaling >$100.00 from each company. Risk factors for undeclared COI were determined at the study and author levels. RESULTS: One hundred twenty-six studies (553 authors) were included. One hundred two studies (81.0%) had one or more authors who received payments from industry and inaccurately declared their COI. Two hundred forty-eight authors (44.8%) did not declare their COI accurately. On multivariate analysis, last authors were found to be at highest risk for undeclared payments (OR 3.59, 95%CI 2.02-6.20), whereas middle authors were at significantly higher risk for undeclared payments than first authors (OR 1.64, 95%CI 1.04-2.56). CONCLUSIONS: The majority of studies investigating the use of mesh in ventral hernia repairs and abdominal wall reconstructions did not accurately declare COI. Last authors are at highest risk of undisclosed payments. Current policies on disclosing COI seem to be insufficient to ensure transparency of publications.

Reporting of Financial Conflicts of Interest in Studies of Placental Membrane Allografts.

Objective: To systematically review the accuracy of self-reported financial conflicts of interest (COI) by authors of placental membrane allograft product studies. Approach: A PubMed search identified placental membrane allograft studies published between 2015 and 2019. Industry payments were collected using the Centers for Medicare & Medicaid Services Open Payments database. Self-declared COI were compared with recorded payments. Risk factors for positive product recommendation were determined at study and author levels. Results: Eighty-nine studies (417 authors) were identified. Seventy-five studies (84%) had at least one author receive undisclosed payments. From 2015 to 2019, 5,841 general payments (totaling $15,558,026) and 1,234 research payments (totaling $18,290,062) were made by 46 companies. Travel/lodging was the most commonly reported transaction (34%). Authors were comprised mostly of podiatrists (27%), plastic surgeons (15%), and orthopedic surgeons (15%). Comparative studies were less likely to have a positive product recommendation compared to noncomparative studies (odds ratio [OR] 0.204, 95% confidence interval 0.06-0.066, p = 0.02). Multivariate analysis showed no association between COI discrepancy and product recommendation. Innovation: The accuracy of self-reported financial COI in placental membrane studies is evaluated for the first time. Conclusion: The majority of placental membrane product studies did not declare all industry payments. Whether these payments represent "relevant COI" remains unclear. In addition, not all placental product companies report to the Open Payments database, suggesting that the issue may be even more significant. This study highlights the need for improved definitions of "relevant COI," a standardized reporting system across journals, and the uniform participation of all medical product vendors.

Assessment of self-reported financial conflicts of interest in vascular surgery studies.

OBJECTIVE/BACKGROUND: With increased collaboration between surgeons and industry, there has been a push towards improving transparency of conflicts of interest (COIs). This study aims to determine the accuracy of reporting of COIs among studies in major vascular surgery journals. METHODS: A literature search identified all comparative studies published from January 2018 through December 2018 from three major United States vascular surgery journals (Journal of Vascular Surgery, Vascular and Endovascular Surgery, and Annals of Vascular Surgery). Industry payments were collected using the Centers for Medicare and Medicaid Services Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and year prior. RESULTS: A total of 239 studies (1642 authors) were identified. Two hundred twenty-one studies (92%) and 669 authors (63%) received undisclosed payments when utilizing a cut-off payment amount of $250. In 2018, 10,778 payments (totaling $22,174,578) were made by 145 companies. Food and beverage payments were the most commonly reported transaction (42%), but accounted for only 3% of total reported monetary values. Authors who accurately disclosed payments received significantly higher median general payments compared with authors who did not accurately disclose payments ($56,581 [interquartile range, $2441-$100,551] vs $2361 [interquartile range, $525-$9,699]; P < .001). When stratifying by dollar-amount discrepancy, the proportions of authors receiving undisclosed payments decreased with increasing payment thresholds. Multivariate analysis demonstrated that first and senior authors were both significantly more likely to have undisclosed payments (odds ratio, 2.0; 95% confidence interval, 1.1-3.6 and odds ratio, 2.9; 95% confidence interval, 1.6-5.2, respectively). CONCLUSIONS: There is a significant discordance between self-reported COI in vascular surgery studies compared with payments received in the Centers for Medicare and Medicaid Services Open Payments database. This study highlights the need for increased efforts to both improve definitions of what constitutes a relevant COI and encourage a standardized reporting process for vascular surgery studies.

Assessment of Conflicts of Interest in Studies of Breast Implants and Breast Implant Mesh.

BACKGROUND: With increased collaboration between surgeons and industry, there has been a push towards improving transparency of conflicts of interest (COI). METHODS: A literature search identified all articles published between 2016 - 2018 involving breast implants/implantable mesh from three major United States plastic surgery journals. Industry payment data from 8 breast implant/implantable mesh companies was collected using the CMS Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments >$100.00 found for the year of publication and year prior. Risk factors for discrepancy were determined at study and author levels. RESULTS: A total of 162 studies (548 authors) were identified. 126 (78%) studies had at least one author receive undisclosed payments. 295 (54%) authors received undisclosed payments. Comparative studies were significantly more likely to have COI discrepancy than non- comparative studies (83% vs 69%, p < 0.05). Multivariate analysis showed no association between COI discrepancy and final product recommendation. Authors who accurately disclosed payments received higher payments compared to authors who did not accurately disclose payments (median $40,349 IQR 7278-190,413 vs median $1300 IQR 429-11,1544, p <0.001). CONCLUSIONS: The majority of breast implant-based studies had undisclosed COIs. Comparative studies were more likely to have COI discrepancy. Authors who accurately disclosed COIs received higher payments than authors with discrepancies. This study highlights the need for increased efforts to improve the transparency of industry sponsorship for breast implant-based studies.

A Cost-Utility Analysis Comparing Immediate Oncoplastic Surgery with Delayed Oncoplastic Surgery in Smoking Breast Cancer Patients.

BACKGROUND: Oncoplastic reduction mammoplasty for smoking breast cancer patients committed to smoking cessation may be performed immediately (increasing smoking-related risk) or in a delayed fashion (increasing radiation-related risk). OBJECTIVE: Our aim was to examine the cost utility of immediate versus delayed oncoplastic reconstruction when operating on a smoking patient with breast cancer and macromastia with a long-term commitment to smoking cessation. METHODS: A literature review determined the probabilities and outcomes for the treatment of unilateral breast cancer with immediate or delayed oncoplastic surgery. Reported utility scores were used to estimate quality-adjusted life-years (QALYs) for varying health states. A decision analysis tree was constructed with rollback analysis to highlight the more cost-effective strategy, and an incremental cost-utility ratio (ICUR) was calculated. Sensitivity analyses were performed to validate the robustness of the results. RESULTS: Immediate oncoplastic surgery is associated with a higher clinical effectiveness (QALY) of 33.3 compared with delayed oncoplastic surgery (33.26), with a higher increment of clinical effectiveness of 0.07 and relative cost reduction of $3458.11. This resulted in a negative ICUR of -50,194, which favored immediate reconstruction, indicating a dominant strategy. In one-way sensitivity analyses, delayed reconstruction was the more cost-effective strategy if the probability of successful immediate reconstruction falls below 29% or its cost exceeds $29,611. Monte-Carlo analysis showed a confidence of 99% that immediate oncoplastic surgery is more cost effective. CONCLUSIONS: Despite the risk of postoperative complications associated with smoking, immediate oncoplastic surgery is more cost effective compared with delayed oncoplastic surgery in which reconstructive surgery would occur after radiation.