The professional collaboration between physicians and industry has brought attention to the issue of conflicts of interest. To increase transparency of the financial relationships between physicians, pharmaceutical companies, and medical device manufacturers, the Physician Payment Sunshine Act (PPSA) was introduced as part of the Patient Protection and Affordable Care Act in 2010.1 In 2014, the Centers for Medicare & Medicaid Services released the Open Payments Database (OPD). This database made public the payments to physicians and hospitals by the manufacturers of drugs, devices, medical supplies, and biologics that were approved by the Food and Drug Administration.2
Conflicts of interest created by industry consulting payments to physicians are of importance because these disclosures represent potential risk for bias in research, such as being associated with more statistically significant results.3,4 Articles reporting a positive conflict of interest disclosure are more often published in journals with a higher impact factor and are strongly associated with a higher rate of positive findings. Prior studies have confirmed that both surgical interventions and drug trials are more likely to have pro-industry outcomes when backed by industry funding.5 Furthermore, orthopedic surgeons declaring a conflict of interest described significantly more positive outcomes in their research.4
Notably, previous research has found that more than half of all orthopedic surgeons in the United States have reported a financial relationship with industry.6 Despite orthopedics being a relatively small specialty, orthopedic surgeons receive substantial industry payments.7 Orthopedic surgeons reportedly have the highest per-physician general payment values among the medical and surgical specialties.8,9 One potential reason for this is the expertise that orthopedic surgeons are able to offer medical device companies that are aiming to develop novel devices. Previous research has concluded that orthopedic surgeons hold the largest proportion of medical device patents compared with other specialists.10 Industry further relies on orthopedic surgeons because the therapeutic armamentarium is restricted to use by or on the order of physicians.
Past studies in various surgical specialties have found a strong correlation between funding, whether through grants or industry compensation, and a higher scholarly impact.11–16 To date, there is limited knowledge regarding the relationship between industry compensation and scholarly impact among orthopedic surgeons. Therefore, the objective of this study was to more clearly define the relationship between industry support and scholarly impact in orthopedic surgery. In addition, this relationship was also explored as a factor of fellowship training. The authors hypothesized that orthopedic surgeons with objectively higher scholarly impact are also among those orthopedic surgeons most highly compensated by industry consulting fees.
Materials and Methods
Industry payments to orthopedic surgeons were obtained from the OPD, which was released to the public by the Centers for Medicare & Medicaid Services on September 30, 2014. The OPD includes payments and other transfers of value, as well as ownership and investment interests, that were made by applicable manufacturers and organizations to physicians beginning August 2013. This database is divided into 3 individual databases: General Payments, Research Payments, and Ownership. Due to concerns regarding the ability to corroborate specific payments and identify individual physicians within the Research Payments and Ownership databases, these databases were excluded from analysis. Therefore, the current research only queried the General Payments database within the OPD from 2015. Because this is a publicly available database, approval for this study from an institutional review board or ethics committee was not applicable.
Physicians who received payments are recorded within the General Payments database with their name, identification number, specialty, payment type, and payment value. Although general payments encompass a variety of payment types, such as consulting fees, food and beverage costs, travel and lodging compensation, and payments for royalties and licensing, the current research limited payments to physician consulting fees only. The decision to exclude food and beverage and travel and lodging costs was made due to the inability to control for confounding factors such as geographic variations. Royalties and licensing payments were excluded because it was not possible to determine the physician's contemporaneous involvement in the source of the licensing or royalties.
All orthopedic surgeons who received at least one industry consulting payment were included for analysis. Physicians who received total consulting fees of at least $20,000 (US dollars) were stratified into the high payment group. Information about surgeon fellowship training listed in the OPD was verified using Internet searches. In many cases, information about surgeon fellowship training was missing initially from the OPD and was corrected.
Two metrics of research productivity, mean publication number and Hirsch index (h-index), were used to assess each surgeon's scholarly impact. The number of research publications and the h-index were obtained from the Scopus database. The h-index is a validated metric that is used to assess the productivity and citation impact of a researcher's work.17–21 It is a numerical value that is calculated by taking the number of publications (N) that have been cited N times. A researcher with 8 publications that had each been cited 5 times would have an h-index of 5. Beyond these metrics, the authors' methods did not seek to extract deterministic data relative to the ultimate clinical usefulness of any published work supported by consulting payments.
Mean publication number and h-index for the high payment group were compared with all other orthopedic surgeons in the sample using independent-samples t tests. A sub-analysis was performed for each orthopedic specialty. All calculations were performed using SPSS Statistics for Macintosh version 23.0 (IBM, Armonk, New York).
A total of 2555 orthopedic surgeons received consulting payments totaling $62,323,143 in 2015. The mean consulting payment for the sample was $24,393 (SD, $45,465). Orthopedic surgeons who completed spine, adult reconstruction, and sports medicine fellowships comprised most of the sample. The mean publication number was greater for the high payment group (61.6; SD, 135.6) compared with all other physicians in the sample (36.1; SD, 95.6; P<.001). For orthopedic surgeons in the high payment group, the mean h-index was 13.7 (SD, 14.3) compared with 10.0 (SD, 11.6; P<.001) for all others in the sample.
Significant variance was observed in the mean number of publications for each fellowship (Table 1). In the high payment group, the mean number of publications was highest for orthopedists who had completed fellowships in musculoskeletal oncology (117.3 publications), adult reconstruction (82.8 publications), and foot and ankle (72.2 publications). The mean number of publications was lowest in this group for orthopedic spine surgeons (42.9 publications) and for those who did not complete a fellowship (29.9 publications). The high payment group was associated with a greater number of publications for adult reconstruction, foot and ankle, and sports medicine orthopedic surgeons.
Mean Number of Publications by Orthopedic Specialty and Consulting Payment Amount
The mean h-index varied between subspecialty of orthopedic surgeon, with hand, musculoskeletal oncology, and pediatric orthopedic surgeons having the greatest h-indices in the high payment group (Table 2). Similar to mean number of publications, the h-index was lowest for orthopedic spine surgeons and for those without a fellowship in the high payment group. Orthopedic surgeons who received consulting fees of greater than $20,000 had significantly higher h-indices if they were fellowship trained in adult reconstruction, foot and ankle, hand, spine, trauma, or sports medicine.
Mean H-Index Values by Orthopedic Specialty and Consulting Payment Amount
Previous research in various surgical specialties has shown a strong correlation between industry funding and higher scholarly impact.11–16 The current study examined whether this trend is also observable within orthopedic surgery in general and in the orthopedic subspecialties. The Centers for Medicare & Medicaid Services OPD enabled the assessment of a large sample of 2555 orthopedic surgeons who reported an industry consulting fee in 2015. Using these data, the authors were able to show a statistically significant relationship between high industry compensation and scholarly impact. Furthermore, this relationship was particularly strong among surgeons with fellowship training in adult reconstruction or foot and ankle surgery. Given the general literature, this finding is not surprising, as multiple studies have shown a positive correlation between industry payments and a higher degree of scholarly impact across many surgical subspecialties, including otolaryngology, neurosurgery, urology, and ophthalmology.11–16
The current study's findings appear to be congruent with the contemporary orthopedic surgery literature. Buerba et al22 recently used the OPD General Payments and Research Payments databases to perform a correlation analysis on the relationship between academic influence and industry payments in orthopedic surgery, finding that h-index and mean publication number had a weak positive correlation with general and research payments in 2014. In another recent utilization of the OPD to assess the relationship between industry support and scholarly impact, Boddapati et al23 examined the average total payments (ie, any payment within the OPD) between years 2014 and 2015 among authors of articles published in the 2016 volumes of The Journal of Bone & Joint Surgery or The American Journal of Sports Medicine. They found that h-index and total publication count increased as a factor of increasing industry payments.
Further subgroup analysis of the current authors' cohort by fellowship training found that high industry payments had a significant relationship with greater scholarly impact for surgeons trained in adult reconstruction, foot and ankle surgery, or sports medicine. Moreover, fellowship-trained orthopedic hand, spine, and trauma surgeons who received high industry consulting fees had a significantly higher mean h-index compared with all other orthopedic surgeons; however, this relationship was not found when examining mean publication number. These findings may be attributable to discrepancies in sample size because the adult reconstruction, foot and ankle, and sports medicine cohorts were among the largest representations of fellowship training, comprising 39% of the collective sample size. Nevertheless, spine surgeons represented the largest cohort of the sub-analysis (23%), and statistically significant results were found for the mean h-index but not for the mean number of publications.
Despite having the highest mean h-index and mean publication number among fellowship-trained orthopedic surgeons in the high payment group, orthopedic oncologists in the high payment group were not significantly different from orthopedic oncologists who were not in the high payment group. This finding might represent a positive influence of industry payments on scholarly impact within the field of orthopedic oncology; however, higher scholarly impact alone appears to be independent of the magnitude of industry consulting fees within this orthopedic subspecialty. Further analysis of all orthopedic oncologists, including those who do not receive any industry compensation, is required to determine whether the current findings represent an inherently stronger relationship of orthopedic oncology with academic productivity.
Given the finding that orthopedic surgeons with great scholarly impact receive greater industry consulting fees, the question remains as to what this means for the field of orthopedic surgery. Industry ties have a long history of shaping the body of orthopedic literature, as both surgical intervention and drug trials backed by industry funding have been shown to have significantly more pro-industry findings.5,24 Furthermore, these studies are often subject to methodological bias, including inadequate sample sizes, use of insufficient doses of competing drugs, inappropriate length of patient follow-up, and even misrepresentation of data.25–27 However, the current research notably examined general consulting fees, which do not contribute to any research funding. It is reasonable to argue that the physicians with the greatest scholarly impact might be those most in demand for their expertise by industries interested in identifying new opportunities for innovation. Whether general industry consulting payments have effects on study results similar to those of payments directly supporting research remains to be determined by future investigation.
Although the media and the public often view industry funding through a negative lens, industry payments play a vital role in the research and development of new drugs and medical devices. Indeed, the American Orthopaedic Association and the Orthopaedic Institute of Medicine released a report in 2012 highlighting the value of industry–surgeon relationships, particularly noting the implications for maintaining innovation and improving patient outcomes.28 For example, while the National Institutes of Health provides the funds for most academic laboratories, industry payments provide most of the funds directed toward developing therapies and clinical trials. Currently, an estimated 75% of all funding for clinical trials in the United States comes from corporate sponsors.29
The American Orthopaedic Association–Orthopaedic Institute of Medicine report also stressed the importance of surgeon–industry relationship transparency.28 Before the implementation of the PPSA and the OPD, discrepancies between payments disclosed by orthopedic surgeons and those reported by the industry had been documented.30 A 2007 US Department of Justice settlement with 5 major joint implant manufacturers mandated that the manufacturers describe the extent of their financial relationships with orthopedic surgeons.31 The increased transparency established by the PPSA is critical for cultivating surgeon–industry relationships for the benefit of patients while maintaining surgeon–patient trust. Nevertheless, although the PPSA stipulates increased scrutiny of physician consulting agreements, the full impact of the PPSA may not be known for several years. Thus, it remains important for surgeons who receive consulting fees to be mindful of how their clinical decision making could be influenced when pursuing scholarly activities. Going further, orthopedic surgeons should be mindful of the probability that a given industry-supported research project will lead to clinically useful data that contribute to and potentially advance the standard of care.
Including all orthopedic surgeons who received an industry consulting fee in 2015 represents a major strength of the current study. To the authors' knowledge, this study represents the first comprehensive assessment of all orthopedic surgeons reporting an industry payment for a single year and their academic influence. This is also the first study to compare this relationship between the orthopedic subspecialties. Furthermore, the objective of this study was explored using two different representations of scholarly impact, mean h-index and mean publication number.
Limitations of this study included inherent flaws in the h-index. For example, there is a correlation between increasing author age and increasing h-index because a publication is more likely to accumulate citations over time. Additionally, the h-index does not distinguish between self-citations and non–self-citations; therefore, authors could inflate their own h-index by repeatedly citing themselves.32 Another limitation of this study involved errors in physician reporting within the OPD. Studies prior to the PPSA noted discrepancies in reporting between physicians and industry.30 There are systems within the OPD enabling physicians to review payment data for accuracy, but the degree to which they are used is unclear. Furthermore, although the authors were able to perform a sub-analysis by surgeon fellowship training, they were not able to incorporate information regarding the circumstances under which consulting agreements were made into their analysis. Despite these limitations, the authors believe that this study represents a comprehensive review of the association between industry consulting fees and scholarly impact in orthopedic surgery.
This assessment of 2555 orthopedic surgeons documented in the OPD as having received an industry consulting fee in 2015 showed a statistically significant relationship between high industry compensation and greater scholarly impact. A sub-analysis revealed that this relationship was particularly strong among fellowship-trained surgeons in adult reconstruction or foot and ankle surgery. These findings indicate that orthopedic surgeons who receive the largest proportion of consulting fees are more often contributors to the body of orthopedic literature. A characteristic of the quality of their contributions is the h-index score.
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- Cvetanovich GL, Chalmers PN, Bach BR Jr, . Industry financial relationships in orthopaedic surgery: analysis of the Sunshine Act Open Payments database and comparison with other surgical subspecialties. J Bone Joint Surg Am. 2015;97(15):1288–1295. doi:10.2106/JBJS.N.01093 [CrossRef]
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- Iyer S, Derman P, Sandhu HS. Orthopaedics and the Physician Payment Sunshine Act: an examination of payments to U.S. orthopaedic surgeons in the Open Payments database. J Bone Joint Surg Am. 2016;98(5):e18. doi:10.2106/JBJS.O.00343 [CrossRef]
- Samuel AM, Webb ML, Lukasiewicz AM, et al. Orthopaedic surgeons receive the most industry payments to physicians but large disparities are seen in Sunshine Act data. Clin Orthop Relat Res. 2015;473(10):3297–3306. doi:10.1007/s11999-015-4413-8 [CrossRef]
- Chatterji AK, Fabrizio KR, Mitchell W, Schulman KA. Physician-industry cooperation in the medical device industry. Health Aff (Millwood). 2008;27(6):1532–1543. doi:10.1377/hlthaff.27.6.1532 [CrossRef]
- Eloy JA, Svider PF, Setzen M, Baredes S, Folbe AJ. Does receiving an American Academy of Otolaryngology-Head and Neck Surgery Foundation Centralized Otolaryngology Research Efforts grant influence career path and scholarly impact among fellowship-trained rhinologists?Int Forum Allergy Rhinol. 2014;4(1):85–90. doi:10.1002/alr.21224 [CrossRef]
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- Lopez J, Susarla SM, Swanson EW, Calotta N, Lifchez SD. The association of the h-index and academic rank among full-time academic hand surgeons affiliated with fellowship programs. J Hand Surg Am. 2015;40(7):1434–1441. doi:10.1016/j.jhsa.2015.03.026 [CrossRef]
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Mean Number of Publications by Orthopedic Specialty and Consulting Payment Amount
|Orthopedic Specialty||Mean (SD) No. of Publications||P|
|All Other Surgeons||High Payment Groupa|
|All (N=2555)||36.1 (95.6)||61.6 (135.6)||<.001|
|Adult reconstruction (n=422)||35.2 (63.4)||82.8 (218.2)||.003|
|Foot and ankle (n=116)||29.0 (42.6)||72.2 (79.7)||.002|
|Oncology (n=30)||47.9 (41.8)||117.3 (134.4)||.192|
|Hand (n=107)||43.1 (68.7)||62.7 (59.4)||.177|
|Spine (n=586)||29.2 (113.0)||42.9 (91.8)||.147|
|Shoulder (n=75)||29.7 (44.6)||48.7 (54.9)||.107|
|Pediatrics (n=96)||43.4 (42.9)||71.9 (87.3)||.121|
|Trauma (n=139)||58.9 (221.4)||56.3 (80.4)||.923|
|Sports medicine (n=433)||36.6 (57.6)||60.2 (91.5)||.011|
|None (n=80)||44.1 (108.3)||29.9 (44.7)||.474|
Mean H-Index Values by Orthopedic Specialty and Consulting Payment Amount
|Orthopedic Specialty||Mean (SD) H-Index||P|
|All Other Surgeons||High Payment Groupa|
|All (N=2555)||10.0 (11.6)||13.7 (14.3)||<.001|
|Adult reconstruction (n=422)||10.6 (13.0)||15.3 (15.6)||.001|
|Foot and ankle (n=116)||9.2 (10.2)||16.3 (13.8)||.004|
|Oncology (n=30)||15.0 (9.8)||26.8 (20.6)||.158|
|Hand (n=107)||10.9 (10.9)||17.3 (13.0)||.012|
|Spine (n=586)||8.0 (10.9)||10.3 (13.6)||.035|
|Shoulder (n=75)||10.3 (9.8)||13.8 (11.8)||.164|
|Pediatrics (n=96)||12.3 (9.6)||16.6 (14.0)||.163|
|Trauma (n=139)||9.5 (10.5)||14.2 (14.6)||.043|
|Sports (n=433)||10.9 (11.7)||13.5 (12.7)||.049|
|None (n=80)||12.7 (21.5)||11.1 (11.8)||.686|