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The Impact of Corporate Payments on Robotic Surgery Research

A Systematic Review

Criss, Cory N., MD; MacEachern, Mark P., BA, MLIS; Matusko, Niki, BS§; Dimick, Justin B., MD, MPH*; Maggard-Gibbons, Melinda, MD, MSHS; Gadepalli, Samir K., MD, MBA

doi: 10.1097/SLA.0000000000003000
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Objective: To quantify the influence of financial conflict of interest (COI) payments on the reporting of clinical results for robotic surgery.

Data Sources and Study Selection: 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.

Main Outcomes and Measures: 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.

Data Extraction and Synthesis: 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).

Results: 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%)].

Conclusion and Relevance: 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: samirg@med.umich.edu.

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.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.annalsofsurgery.com).

Industrial collaboration is vital to surgical innovation; however, this relationship may have potential negative impacts on practice, such as device selection, operative approach, and the conduct of research.1–7 Industry influence on surgical research studies can take on 2 forms: industry-sponsorship of the study or a relationship with the surgical authors. There is some evidence to suggest that sponsored studies may be more likely to report conclusions supporting industry and surgeons reporting a conflict of interest (COI) are more biased toward the industry product.8–16 Efforts to improve disclosure statements and adopt new COI guidelines to increase transparency of financial partnerships between industry and benefactors led to passing of the Physician Payments Sunshine Act in 2010.17–23 This has catalyzed recent work to uncover discordance between reporting of disclosure statements and actual COI.24–29 However, it remains unclear whether a tipping point exists where industrial influence effects research outcomes, a point where COI are not created equal.

In other words, is there an incremental impact of the amount of financial COI upon the researchers’ work, analysis, and reported findings?30 An individual receiving a large amount of financial support ($100,000) may be more influenced than those receiving a minimal amount ($50). The level of conflict is likely not equal. Societies and journals implement arbitrary financial “cutoffs” designating a significant conflict, despite minimal evidence supporting this value. These attempts fail to characterize the effect on research from financial payments.31

Although collaboration is important to innovation, the varying effect of a financial relationship on academic research needs to be stratified. The goal of our study is to quantify the impact of varying levels of financial COI on reported research findings. We identified comparative clinical studies on robotic surgery to assess the influence of financial support on the results and overall congruency of the conclusions. We investigated whether a financial relationship exists, where an increasing dollar amount of funds received affects reported research findings.

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METHODS

Search Strategy

We registered our study with PROSPERO (CRD4201705610) on February 1, 2017. A literature search of 3 Ovid MEDLINE databases (MEDLINE; In-Process & Other Non-Indexed Citations; and Epub Ahead of Print) was conducted in May 2017 to identify a large sample of clinical studies that reference the da Vinci robot in a surgical context. To be retrieved by the search, citations had to reference “da Vinci” in the article title or abstract fields in conjunction with surgery-related Medical Subject Headings or title or abstract terminology. No date restrictions were applied to the search, but non-English and nonclinical studies were excluded. The intent was to only include studies occurring within the United States. This was to ensure adequate cross-referencing with “Open Payments” (OP) website (https://www.cms.gov/openpayments) for financial data, which is only available for U.S. providers. Studies involving head and neck, endocrine, and orthopedic procedures were also excluded.

Our database search algorithms were determined and developed with the aid of the authors and biomedical research librarian. Complete search algorithms for database searches are available in the Database Search Algorithm section of the Supplementary Material, http://links.lww.com/SLA/B493.

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Study Selection

Two authors (C.N.C., S.K.G,) independently reviewed all citations. After duplicates were removed, the remaining citations were moved to DistillerSR (Evidence Partners Inc, Ottawa, Ontario) for study selection.

Titles and abstracts were screened first, followed by 2 rounds of full-text review. Conflicts were resolved through discussion before advancement.

The main objective was to assess the impact of financial COI payments on studies comparing the effectiveness of the da Vinci robot. The screening questions can be seen in Fig. 1. Studies were included if they were (1) either randomized controlled trials (RCT) or observational studies focused on (2) clinical outcomes related to the da Vinci robot. Furthermore, studies with (3) subspecialties consisting of general surgery/gastrointestinal (GI), colorectal surgery, cardiothoracic surgery, urology, and obstetrics/gynecology were included. Any additional subspecialty was excluded (ie, orthopedic surgery, ENT, endocrine surgery). These subspecialties were chosen on the basis of data obtained from a previous study, demonstrating these as the top earning subspecialties from Intuitive Surgical Incorporated (ISI).32 Studies that were deemed nonclinical were excluded, such as articles focused on education and simulation. Furthermore, articles were excluded if they were not published by U.S. authors. This did not necessarily exclude international journals, as studies were included if there were US authors, even if it was a collaboration with international authors. A separate search was performed on highly cited international journals in an attempt to capture any large-scale US studies that were published internationally.

FIGURE 1

FIGURE 1

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Data Extraction and Quality Assessment

Data extraction was performed by 2 authors (C.N.C. and S.K.G.). Data points chosen for extraction were done so based on previous research on this topic and input from all authors. These included authors, journal name, date of submission, date of publication, journal impact factor, center involvement (single, multi-institutional national, multi-institutional international), funding, study design, number of patients, control type, subspecialty, primary outcome, secondary outcomes, and disclosure statements.

Additional data were dually extracted and utilized for quality assessment. Variables focused on methodological quality, including how results were concluded (P value, P value and CI, CI only, descriptive statistics) were obtained by 2 authors (C.N.C., S.K.G). The risk of bias was calculated on the basis of the Newcastle-Ottawa scale for observational studies, and the Cochrane risk of bias assessment tool for RCTs.33,34

Additional data were extracted from studies, including individual authors, conclusion statements, and disclosure statements. These data points were reviewed by 2 separate authors (C.N.C, S.K.G.) independently, with conflicts resolved by consensus or inclusion of a third author (M.P.M.).

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Assessment of Payment Data Utilizing CMS.gov

Individual U.S. authors with an NPI number were identified using the OP database. This is a publicly available database, wherein financial payments are reported every June 30, since 2013 (last 5 months). Providers are given a grace period of 45 days to appeal or confirm the payments until official publication. Each author was searched and recorded for any payment amounts received for each year by ISI. All financial payments were included, including consulting, travel and lodging, education, honoraria, speaking, educational feeds, gifts, licensing, and royalties. These were all taken as one entity, defined as “financial payments.” The total payments were combined for each study and all years, equating a total amount per study. This pertained to any point from the initial submission of their manuscript until May 2017. Financial payments were only available during the time OP was available. Importantly, some studies were published before the initiation of OP; however, the total payments used were only available during the OP available years.

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Evaluation of Study Support and Concluding Statements

Conclusion statements were assessed for the included studies based on established criteria.32,35,36 Studies were categorized into 3 separate groups based on their concluding statements. A study was considered “positive” if the concluding statement made a favorable inference supporting the use or advantages related to the robot. An “equivocal” study was designated if the concluding statement made either no strong conclusions regarding the clinical effectiveness of the robot, or if there was an equal distribution of positive and negative statements. A “negative” study was designated if the concluding statement was overall reporting that the robot had negative clinical outcomes or was overall less efficacious than the control or current literature.

The primary outcome of each study was evaluated for statistical significance. This method has been previously described.36 Furthermore, the primary outcome was assessed to determine whether the results of the study support the concluding statement. This was to determine if studies had justification for their conclusions statements. The primary outcome was considered supportive if it substantiated the conclusion, and nonsupportive if it did not. Of note, just because a primary outcome was not statistically significant, did not necessarily mean that it did not support the concluding statement. For example, some studies concluded that results were “comparable” or “safe and feasible.”

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Assessment of Disclosure Statement Accuracy

Each study was evaluated for the presence of a disclosure statement (“Disclosure Statement Present”). These statements were further assessed for a disclosure for ISI for each individual author (“Disclosure Statement for ISI”). To assess the accuracy of the disclosure statements, these findings were cross-referenced with the financial payments. If one author had a discrepancy between the disclose statement and the actual COI, the study was labeled as such (“Discrepancy between Disclosure and Actual COI”). Of note, a discrepancy could only be assessed during the time that OP was active, rendering any studies before early 2013 excluded or indeterminate. Furthermore, a financial discrepancy was determined utilizing the year submitted and year published. This was to avoid inaccurate discrepancy reporting due to delayed publication from the time of the original declaration statement.

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Financial Relationship/Indirect Sponsorship

Utilizing financial payment amounts for each study as an indicator of COI, we evaluated the studies considered “Supports Robotic Surgery” using a Receiver Operating Curve analysis (ROC) to assess each value as a potential optimal cutoff point affecting clinical outcomes (Fig. 2; Table 1). We then assessed the association of the identified optimal cutpoint and whether or not a study supported robotic surgery via simple logistic regression analysis where dollar amounts greater than the optimal cutpoint were compared with those less than the cutpoint (as the reference). A study was considered “Indirectly Sponsored” if the clinical conclusions were associated with the financial COI payments.

FIGURE 2

FIGURE 2

TABLE 1

TABLE 1

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Data Synthesis and Analysis

Sample characteristics and outcomes are reported as mean ± standard deviation or median/interquartile range for continuous variables and number of observations/percent for categorical variables. The accuracy of financial support as a predictor of support for robotic surgery was further assessed at various cut-offs of dollar amount received by ROC analysis. The empirical optimal cut-off of dollar amount received and area under the curve (AUC) at optimal cut-off were derived using the Lui method.37 A graphical comparison of the optimal cutpoint compared with a select number of alternative cutpoints was also examined. The association between support for robotic surgery and dollars above/below the optimal cutpoint was evaluated by simple logistic regression analysis. All analyses were conducted in STATA15 and significance was set at P < 0.05.

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RESULTS

The search retrieved 714 articles; after review at title/abstract level, 195 articles were evaluated for full-text review. Two rounds of full-text review yielded a total of 33 total studies, which were included in our analysis (Fig. 1).38–70

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Study Demographics and Characteristics

Study demographics and characteristics are listed in Table 2. For the 33 studies, 23 unique journals were represented with a median impact factor of 3.3 (range 1.05 to 13.9) and they reported on a median of 111 patients (total; 16,562, range; 10 to 6420). There were 9 RCTs and 24 observational studies. A majority of studies were single center (19/33, 58%), with 11 (33%) multi-institutional national, and 3 (9%) multi-institutional international. Funding sources were mainly self-funded/nonfunded/not reported (25/33, 76%), followed by government (5/33, 15%), with industrial funding in 2 (6%) studies. The most common subspecialty was obstetrics/gynecology (15/33, 45%), followed by general surgery (10/33, 30%), and urology (8/33, 24%). No cardiac or thoracic studies were represented.

TABLE 2

TABLE 2

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Study Design

Study design and quality characteristics are provided in Table 3. The control arm was mainly standard laparoscopy (18/33, 55%), followed by open procedures (13/33, 39%). The most common primary outcome was operative time (14/33, 42%), followed by postoperative complications (7/33, 21%). Furthermore, the method used to report significance was mainly by P value only (20/33, 61%), followed by P value and confidence interval (CI) (10/33, 30%), CI only (2/33, 6%), and descriptive statistics (1/33, 3%).

TABLE 3

TABLE 3

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Assessment of Payment Data Utilizing Open Payments

A total of 30 (91%) studies had authors who received financial payments for a median of $3364.46 per study, and a total of $4,107,500.27 (range; $9 to $1,775,378.03) for all studies. Regarding funding, 1 study was directly sponsored by ISI, with another study by Covidien.

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Evaluation of Study Support and Concluding Statements

Of the 33 studies, 17 (52%) had a conclusion statement “positive” for robotic surgery, while 12 (36%) were “equivocal,” and 4 (12%) were “negative” for robotic surgery. This equates to 17 (52%) “Supporting Robotic Surgery,” and 16 (48%) “Not Supporting Robotic Surgery.” An evaluation of primary outcomes demonstrated that 16 (48%) had a primary outcome that was statistically significant and 17 (52%) had a primary outcome without statistical significance. The primary outcome findings supported the conclusions in 30 (91%) of the studies overall (Table 3). There were 3 (9%) studies that did not have a primary outcome supporting the conclusions. One study only commented on the secondary outcome of the study (which demonstrated a contrasting view from the primary outcome), the second did not comment on the findings of the primary outcome, and the third reported a conclusion stating “cost-effectiveness,” without supporting results within the manuscript.

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Assessment of Disclosure Statement Accuracy

A disclosure statement was present in 29 (88%) studies, with funding for ISI declared in 15 (45%) studies. Of the 14 undeclared, funding was determined using OP in 9 (27%) studies. These studies were placed into the category “Discrepancy Between Disclosure and Actual COI.” Funding was confirmed to be absent or the study was before the availability of OP in 6 studies where a disclosure statement was present (Table 4).

TABLE 4

TABLE 4

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Financial Relationship/Indirect Sponsorship

A ROC curve was plotted at various thresholds and demonstrated that dollars received had fair predictive ability to discriminate between supports robotic surgery and does not support robotic surgery (AUC = 0.69, CI = 0.49–0.88) (Fig. 2, Table 1). The analysis yielded a cutpoint at $9557.31, with a sensitivity of 0.65 and specificity of 0.81, and AUC of 0.73 at cutpoint (Fig. 2). The optimal cutpoint was then plotted and compared with a select number of alternative cutpoints (Fig. 3). The curve of at the $9557 cutpoint appears furthest to the left when compared with the alternative cutpoints indicating optimal sensitivity, specificity, and AUC (Fig. 3; Table 1). Dollars received was dichotomized at the optimal cutpoint of $9557.31, and groups were compared. Studies that received more than $9557.31 supported robotic surgery significantly more often than studies that received $9557.31 or less (78.57% vs 31.58%, P = 0.013) with an odds ratio of 2.07 (CI: 0.47–3.67; P = 0.011). (See Fig. 4).

FIGURE 3

FIGURE 3

FIGURE 4

FIGURE 4

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Evaluation of Quality and Bias

Assessment of bias/quality was performed using the Newcastle-Ottawa Scale for observational studies and Cochrane Risk Assessment of Bias for RCTs. Overall, observational studies had a median score of 8 (range 5 to 9), and RCTs overall had a low risk of bias (9/9, 100%). (Table 5 In Supplementary Appendix, http://links.lww.com/SLA/B493)

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DISCUSSION

Studies reporting better clinical outcomes for robotic surgery had higher financial COI payments to authors. Specifically, a combined financial support over $10,000 has the strongest association with being more likely to conclude positive findings for robotic surgery. Interestingly, conclusions were overall supported by study results and support for robotic surgery was equally distributed among studies. Almost one-third of studies with a disclosure statement had discordance with whether they received financial payments from OP.

Here, we evaluated the relationship between industry support and reported research findings. A financial COI sponsorship was associated with a higher likelihood of reporting results in favor of robotic surgery over the alternative approach, introducing the concept of Indirect Sponsorship. The optimal point of predictability was just under $10,000, above which the likelihood for studies to show robotic support was the highest. These findings support the claim that all COI should not be treated equally, nor should they be grouped into the same category of bias. The relevance of this concept is paramount, as journals and societies chose financial limits arbitrarily, without evidence.71,72 Our findings suggest a monetary amount where clinical relevance exists.

The studies we included were of high-quality study design and evidence. This was evident in our quality assessment, wherein an overwhelming majority had a low risk of bias and high quality as confirmed by the NOS and Cochrane tool. Although this is likely a result of our screening process, this validates our search criteria. Furthermore, the degree of potential COI was evident in 91% of studies, which received financial payments from ISI. This aspect is concerning, as the potential influence of industry remains at the most influential ranks.

In an effort to evaluate the potential bias of studies, conclusion statements were evaluated, as these represent the summary of findings. Our data suggest an equal distribution of studies supporting and not supporting robotic surgery, which is not surprising, as the controversy over the clinical advantages of robotic surgery continues to be debated. Another potential area of bias exists in the interpretation of data. This was evident in a study by Als-Nielsen et al,5 who concluded that drug trials funded by for-profit organizations are more likely to support industry due to biased interpretation of results. Furthermore, it has also been proposed that “positive,” or in this case, “statistically significant” studies, are more likely to be published, regardless of quality.36 Interestingly, the studies in this review had conclusions supported by data and an equal distribution of statistically significance. This demonstrates 2 noteworthy points. First of all, this review consists of well-validated, high-quality studies, with a low risk of bias. Second, if an indirect sponsorship does exist, it is possible that the time of influence or bias begins at the study design level, and not at the interpretation of data or conclusions. This possibility was brought to light in a survey of 3247 scientists published in Nature, demonstrating that over 15% of scientists engaged in Changing the design, methodology, or results of a study in response to pressure from a funding source.”73

Currently, the most globally accepted method to evaluate COI remains within disclosure statements. With historical instances of unethical research studies, there has been an emphatic push toward standardization within journals and societies.4,12 As it stands, disclosures are not vetted by journals, nor is there a standardized guideline for all journals. This would not be an issue if it were not for the high rate of discordance of disclosure statements with actual COI.25,26,74 Previous rates as high as 63% along with our rate of 27% demonstrate a clear lack in communication or transparency.24 Although this is concerning, there are many simple nondeceptive explanations for this. At times, journals take years from submission to publication and likely COI statements are not readdressed. Another scenario is the corresponding author signs off on the COI of all the authors, which may lead to inaccuracy. Other times, an author may forget they had a meal or educational session paid for in the past year. These scenarios are real and possibly lead to discrediting disclosure statements. This further validates our effort to redefine the potential effect on clinical outcomes correlated to financial payments.

Our study has several limitations. First, ISI was chosen as a focus of this paper because robotic surgery is unique in the field of surgery, as it is the major manufacturer and distributor to the da Vinci robot. Because of this, payments from ISI are likely directly tied to robotic use, a less likely scenario in other industrial companies wherein multiple products are made and distributed. The objective was not to target robotic surgery but to evaluate a unique aspect of industry. It is also important to note that our conclusions can only be made about the robotic industry, as payments in other areas are likely variable. Next, the OP database has multiple drawbacks, including no financial data before 2013, potential inaccuracies not vetted by physicians, and available for U.S. authors only. Even so, the OP database is currently the only resource available. Financial data for each study could only be gathered while OP was operational, which may have been years after the study had finished or been published. In addition, our analysis of financial payments did not specify the various aspects identified on OP, including consulting, travel and lodging, education, honoraria, gifts, licensing, and royalties. Next, although we took a similar approach to previous studies on this topic, determining the viewpoint, “positive” or “negative,” can be relatively subjective. In our efforts to standardize this, we had 2 independent authors review of the articles in addition to using methods previously utilized. Finally, we presented article data as an aggregate, not as individual study assessment mainly due to the sensitive nature of this topic. Although this can be referenced in the Supplementary Materials section, the studies remain de-identified, which remained so due to the potential implications; however, these data points remain public information and are readily available.

As mentioned earlier, the concept of COI within medicine is a highly sensitive and complex topic. There is a consensus to standardize the accuracy of disclosures, with some leaders in the field advocating for strict guidelines for societies and PMA leaders.17,19 Previous studies in plastic surgery, orthopedic surgery, neurosurgery, and general surgery have all demonstrated bias within research and advocated for improved transparency.8,24,29,75,76 However, our results introduce a new approach to COI, where simply the implementation of a disclosure statement may not entirely reflect the actual relevance of the relationship.

Our findings are relevant to industry, providers, patients, and leaders of scientific journals. Industrial partnerships and collaboration are essential to advancing medical knowledge and technology and these should be fully supported. As a provider, awareness of potential unconscious bias with industry should be self-examined. However, holding providers to a $0 disclosure policy, as some have previous recommended, is unfeasible and likely not warranted.19 Patients in the general population will also find these data relevant, as they should remain informed to the implication of COI payments on research. For journals, the possibility of a tipping point suggests that COI payments are not created equal and scientific journals should acknowledge this concept.

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Keywords:

conflict of interest; corporate; da Vinci robot; disclosure statements; financial disclosures; indirect sponsorship; industry; open payments; sponsoring surgeons; Sunshine Act

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