Abstract
Background:
The U.S. Department of Justice’s investigations into financial relationships between surgical device manufacturers and orthopaedic surgeons have raised the question as to whether surgeons can continue to collaborate with industry and maintain public trust. We explored postoperative patients’ views on financial relationships between surgeons and surgical device manufacturers, their views on disclosure as a method to manage these relationships, and their opinions on oversight.
Methods:
From November 2010 to March 2011, we surveyed 251 postoperative patients in the U.S. (an 88% response rate) and 252 postoperative patients in Canada (a 92% response rate) in follow-up hip and knee arthroplasty clinics with use of self-administered questionnaires. Patients were eligible to complete the questionnaire if their surgery (primary or revision hip or knee arthroplasty) had occurred at least three months earlier.
Results:
Few patients are worried about possible financial relationships between their surgeon and industry (6% of surveyed patients in the U.S. and 6% of surveyed patients in Canada). Most patients thought that it is appropriate for surgeons to receive payments from manufacturers for activities that can benefit patients, such as royalties for inventions (U.S., 69%; Canada, 66%) and consultancy (U.S., 48%; Canada, 53%). Most patients felt that it is not appropriate for their surgeon to receive gifts from industry (U.S., 63%; Canada, 59%). A majority felt that their surgeon would hold patients’ interests paramount, regardless of any financial relationship with a manufacturer (U.S., 76%; Canada, 74%). A majority of patients wanted their surgeon’s professional organization to ensure that financial relationships are appropriate (U.S., 83%; Canada, 83%); a minority endorsed government oversight of these relationships (U.S., 26%; Canada, 35%).
Conclusions:
Most patients are not worried about possible financial relationships between their surgeon and industry. They clearly distinguish financial relationships that benefit current or future patients from those that benefit the surgeon or device manufacturer. They favor disclosure with professional oversight as a method of managing financial relationships between surgeons and manufacturers.
Financial relationships between device manufacturers and orthopaedic surgeons that have been reported to the U.S. Senate include lucrative consulting agreements for which minimal work was actually performed, contracts paying royalties without any transfer of intellectual property, inappropriate gifts, and direct payments to surgeons for using a specific manufacturer’s device1. These practices can increase device costs, decrease public trust, undermine the patient-surgeon relationship, and may lead to inappropriate patient care2.
Legislators in the U.S. have proposed a management strategy in the Physician Payment Sunshine Provision within the Patient Protection and Affordable Care Act of 20103. This law mandates that payment of more than $100 from a device manufacturer to a surgeon must be disclosed to federal authorities and made available on a publicly searchable web site (beginning September 30, 2013)3. Proactively, the American Academy of Orthopaedic Surgeons (AAOS) has recommended that any financial relationship with a manufacturer relating to a patient’s treatment be disclosed directly to the patient4.
Proponents of disclosure as a method of managing physician-industry relationships contend that disclosure promotes informed decision making, maintains trust, respects the patient’s right to know, minimizes legal liability, and discourages inappropriate financial relationships5-7. Critics hold that disclosure merely places the burden and responsibility of managing conflicts of interest on the recipient of the information without providing guidance for understanding and managing the conflict8,9.
Prohibition of financial relationships between surgeons and manufacturers is not a practicable management strategy because surgeon collaboration with industry is now widespread and highly productive for designing and refining surgical devices and techniques10. Surgeon feedback, based on tacit knowledge derived from clinical experience, is needed to anticipate and prevent potential problems with novel devices10. Surgeons who participate in the training of other surgeons and operating room personnel ensure the safe use of new devices10. Teaching new technology brings professional recognition for expertise and offers opportunities to learn from other leaders, industrial partners, and practitioners. These incentives are helpful but insufficient to justify time away from practice without compensation. Manufacturers recognize and reward the inventors, design modifiers, and teachers of their technological contributions to patient care.
Surveys exploring financial relationships between health-care professionals and industry have included views of potential research participants, research participants, potential patients, and medical patients; a recent review of this heterogeneous collection of studies concluded that participants want financial relationships to be disclosed11. However, no surgical patients were included in this review. To the best of our knowledge, there is only one published survey of surgical patient views on financial relationships between surgeons and manufacturers. Khan et al. administered an eight-question survey to a mixed group of orthopaedic patients in the waiting room of a clinic in Pittsburgh, Pennsylvania12. The majority of those patients believed that physicians should be compensated for advising medical device manufacturers. That study was conducted before the release of media reports of financial relationships between surgeons and manufacturers, had an unreported response rate, and included both surgically managed and medically managed patients12.
We explored postoperative arthroplasty patients’ views on financial relationships between orthopaedic surgeons and surgical device manufacturers, their views on disclosure as a method to manage these relationships, and their opinions on oversight. We present our findings to provide needed surgical patient perspectives to the discussion of how physicians and surgeons can work productively with industry and still maintain public trust.
Study Patients
From November 2010 to March 2011, 503 postoperative arthroplasty patients completed self-administered questionnaires at two academic hospitals in Toronto, Ontario, Canada (Mount Sinai Hospital and Holland Orthopaedic & Arthritic Centre), and at an academic hospital in Boston, Massachusetts (the New England Baptist Hospital). In total, fifteen surgeons contributed patients to this study. Seven surgeons had financial relationships with manufacturers that included royalties, consultancy payments, speakers’ bureau presentations, or research support. English-speaking patients who were at least eighteen years old and who had undergone primary or revision hip or knee arthroplasty at least three months earlier were eligible to participate in the study. Of the 285 patients in the U.S. who were approached, 251 agreed to complete the questionnaire (an 88% response rate). Of the 273 patients in Canada who were approached, 252 agreed to complete the questionnaire (a 92% response rate). In all, 500 of 503 surveys had complete data.
Questionnaire Design
We developed our survey questionnaire by conducting qualitative interviews with postoperative arthroplasty patients at Mount Sinai Hospital in Toronto. Their views on conflicts of interest were audiotaped, transcribed, rendered anonymous, and analyzed. After interviewing thirty-three patients, we reached a point beyond which no new concepts arose13. We used many of the patient-derived concepts to draft our survey questions. We added relevant themes and questions that had been found useful in previous surveys12,14-19. We tested a questionnaire derived from these sources on nonsurgical volunteers and postoperative arthroplasty patients and also used cognitive interviews to ensure that questions would be understood20.
The final questionnaire, reproduced in the Appendix, contained forty-nine items in six domains: trust, awareness and concern about financial relationships between surgeons and device manufacturers, opinions regarding oversight, attitudes toward disclosure of financial relationships, sociodemographic data, and surgical characteristics. Items regarding concern about financial relationships were repeated at the end of the questionnaire to determine whether the questionnaire itself increased patients’ concerns. The questionnaire provided information to patients regarding possible financial relationships that can exist between surgeons and manufacturers. We used neutral language so as to not bias patient responses (see Appendix). For example, we used the term “financial relationship” instead of “conflict of interest” or “financial ties” because we felt that the latter phrases had negative connotations.
Survey Administration
Patients attending follow-up arthroplasty clinics at the participating hospitals were asked by clinic personnel or the first author (M.W.C.) to complete the self-administered questionnaire. Every patient who met the inclusion criteria was invited to participate. Patients were informed that participation was voluntary, that their surgeon would not know who participated, and that the survey was completely anonymous. Participating surgeons were not directly involved in the recruitment of patients. Consent was demonstrated by the patient’s completion of the survey. To reduce potential bias, patients received no assistance in completing the questionnaire. The questionnaire was previously tested to ensure that the questionnaire was comprehensible. Demographic and surgical characteristics were obtained from all patients who refused participation. The only incentive for participation was $10, which was given to offset the cost of extended parking. The research ethics board at each participating center approved the protocol and the questionnaire.
Statistical Analysis
We analyzed the U.S. and Canadian samples separately since they were presumed to be heterogeneous. We summarized the survey results according to the proportion of patients who responded to each question. We performed univariate analysis to describe frequencies of responses to each item. For bivariate analysis, we collapsed Likert scales into three response categories (“agree,” “no opinion,” and “disagree”) and treated responses as ordinal categorical data with use of chi-square and Somers’ d measures of association.
Source of Funding
No external funding sources were utilized for this study.
Patient Characteristics
There were no significant differences between the U.S. and Canadian samples regarding sex, age, annual income, number of joint replacement surgical procedures, time since most recent surgery, or postoperative complications. The age and sex profiles are consistent with published demographic data on hip and knee arthroplasty in the U.S. and Canada21-23. The U.S. patient sample contained a slightly higher proportion of patients with college or university degrees than the Canadian sample (χ2 = 7.852, p = 0.049). Demographic characteristics of U.S. and Canadian participants are provided in Table I. Patients who refused participation had similar characteristics.
Awareness and Concern About Financial Relationships
More U.S. patients (54%) than Canadian patients (35%) were aware that surgeons could have financial relationships with device manufacturers (χ2 = 17.842, p < 0.001; Table II). Similarly, 70% of U.S. patients and 55% of Canadian patients were aware that physicians could have financial relationships with pharmaceutical companies (χ2 = 13.359, p = 0.001; Table II). Despite this level of awareness, only 6% of U.S. patients and 6% of Canadian patients surveyed were worried about possible financial relationships between their surgeon and industry (Table III). At the end of the survey, 17% of U.S patients and 22% of Canadian patients were worried about possible financial relationships between their surgeon and manufacturers (Table III). Information provided on financial relationships between surgeons and manufacturers may have heightened awareness and resulted in the increased patient worry at the end of the survey. Only three U.S. patients and three Canadian patients surveyed in this study recalled being told about their surgeon’s financial relationships prior to the survey (data not shown).
Opinions Regarding the Appropriateness of Financial Relationships
Both U.S. and Canadian patients made a distinction between financial relationships that have the potential to be beneficial to patients (e.g., royalties for inventions that may lead to improved patient outcomes) compared with those that are profitable to surgeons and industry alone (Table IV). For example, 69% of U.S. patients and 66% of Canadian patients thought it was appropriate for their surgeon to receive royalties for a patent on a product that the surgeon had designed; only 11% of U.S. patients and 13% of Canadian patients thought it appropriate for their surgeon to receive gifts from industry worth more than $100. Examples of gifts provided in the survey were “hotel costs covered by a company at a conference,” “free textbooks from a company,” and “free meals from a company.” Only 21% of U.S. patients and 22% of Canadian patients thought that it was appropriate for their surgeon to own shares in the company that supplied their prosthesis. There were no significant differences between U.S. and Canadian patients’ opinions regarding the appropriateness of financial relationships.
Trust in the Surgeon
The first domain of the questionnaire, preceding any items concerning financial relationships, explored patient trust; 96% of U.S. patients and 97% of Canadian patients stated that they had complete trust in their surgeon (data not shown). Similarly, 76% of U.S. patients and 74% of Canadian patients felt their surgeon would make the best choices for their health, regardless of financial relationships with device manufacturers (data not shown).
Views on Disclosure of Financial Relationships
Table V provides information on patients’ views regarding the disclosure of their surgeon’s financial relationships with manufacturers. Twenty-eight percent of U.S. patients and 25% of Canadian patients thought that knowing their surgeon’s relationships with industry would have helped their preoperative decision making. Forty-seven percent of U.S. patients and 42% of Canadian patients wanted their surgeon to verbally disclose financial relationships with manufacturers. Forty-two percent of U.S. patients and 38% of Canadian patients surveyed wanted their surgeon to provide disclosure of financial relationships with manufacturers in the form of a pamphlet. Patients surveyed showed limited support for U.S. disclosure legislation, with 38% of U.S. patients and 30% of Canadian patients agreeing that surgeons should place their financial relationships on a publicly accessible web site; 33% of U.S. patients and 32% of Canadian patients would visit such a web site preoperatively.
Opinions Regarding Oversight of Financial Relationships
A majority of U.S. patients (83%) and Canadian patients (83%) surveyed wanted their surgeon’s professional organization to ensure that financial relationships are appropriate, while 26% of U.S. patients and 35% of Canadian patients favored monitoring by a government agency (Table VI).
Predictors of Views and Opinions
U.S. Sample
U.S. patients who were aware that financial relationships between a surgeon and a surgical device manufacturer could exist prior to participation in the study (“aware patients”) were more likely to agree that financial relationships that had the potential to benefit patients were appropriate (54% of aware patients thought that being a consultant was appropriate compared with 31% of unaware patients, Somers’ d = 0.176, p = 0.014; 52% of aware patients thought that giving lectures on behalf of a company was appropriate compared with 31% of unaware patients, Somers’ d = 0.180, p = 0.013; 75% of aware patients felt that being paid royalties for a patent was appropriate compared with 54% of unaware patients, Somers’ d = 0.185, p = 0.007).
U.S. patients who had graduated from college or university were more likely to disapprove of their surgeon receiving gifts worth more than $100 from the company that supplied their joint replacement (72% of those who graduated from college or university thought that receiving gifts worth more than $100 was inappropriate compared with 54% of those who had not graduated from college or university, Somers’ d = –0.146, p = 0.020). The same association was not found in the Canadian sample.
At the end of the survey, U.S. patients with complications were more likely to be worried about their surgeon’s possible financial relationships with manufacturers (22% of patients with complications were worried about their surgeon’s possible financial relationships with manufacturers compared with 15% of patients without complications, Somers’ d = 0.195, p = 0.008). Patients with complications were no more likely to be worried than patients without complications at the beginning of the survey.
There was no consistent association of age, sex, income, number of surgical procedures, or time since surgery with U.S. patients’ views on financial relationships between surgeons and device manufacturers.
Canadian Sample
As in the U.S. sample, Canadian patients who were aware that financial relationships between a surgeon and a surgical device manufacturer could exist prior to participation in the study were more likely to agree that financial relationships that had the potential to benefit patients were appropriate (64% of aware Canadian patients thought that being a consultant was appropriate compared with 37% of unaware patients, Somers’ d = 0.237, p < 0.001; 58% of aware patients thought that lecturing on behalf of a company was appropriate compared with 45% of unaware patients, Somers’ d = 0.140, p = 0.037; 77% of aware patients felt that being paid royalties for a patent was appropriate compared with 51% of unaware patients, Somers’ d = 0.245, p < 0.001). Like their U.S. counterparts, aware and unaware Canadian patients were equally likely to agree that gifts to surgeons were inappropriate.
Level of education was associated with awareness of financial relationships in the Canadian sample. Canadian patients who had graduated from college or university were significantly more likely to be aware that financial relationships could exist between health-care providers (surgeons or physicians) and manufacturers (69% of those with a college or university degree compared with 48% of those without a college or university degree, Somers’ d = 0.213, p = 0.001).
There was no consistent association of age, sex, income, number of surgical procedures, time since surgery, or complications with Canadian patients’ views on financial relationships between surgeons and device manufacturers.
The participants in this study trusted their surgeon’s professional organizations to manage the complexities of financial relationships with industry. As in previous surveys, our study participants endorsed financial contributions from industry for activities that have the potential to benefit patients12,14. Despite the heterogeneity of the populations, health-care insurance, and delivery systems, the views of patients in both the U.S. and Canada were remarkably similar on trust, disclosure, and oversight of financial relationships between surgeons and manufacturers. The difference in level of awareness of financial relationships between U.S. patients and Canadian patients is probably related to media coverage. Greater media coverage may also explain the higher patient awareness of physicians’ financial relationships with the pharmaceutical industry than surgeons’ relationships with device manufacturers in both the U.S. and Canadian samples.
Education to increase awareness of the general public about the important interactions of surgeons and manufacturers seems more appropriate and less threatening than disclosure of conflicts at the point of care. Although more than 40% of U.S. patients and Canadian patients who were surveyed wanted their surgeon to verbally inform them of financial relationships with manufacturers, a substantial proportion of patients did not want these relationships discussed (Table V). Many patients facing the immediate prospect of a surgical procedure may view financial disclosure as an unnecessary and unwanted burden, shifting focus away from aspects of treatment that are more important to them at that time, such as duration of disability, pain, and the prospect of adverse events14,24.
The legislated proposal of a web site listing all industry contributions to surgeons offers the advantage of moving financial disclosure away from the point of care. It seems reasonable to include explanations of the rationale for payments to reduce the implication that disclosure is intended to cause public embarrassment. Representatives of industry and the profession could contribute to this mode of constructive public education. A public web site has been suggested as the most effective means of disclosing this information to patients and peers25. Disclosure through a written pamphlet may also effectively provide this information without shifting focus from the necessary aspects of the consent process, and would also be effective for patients who do not have access to the Internet.
The majority of participants in this study preferred professional rather than government oversight to ensure that their surgeon’s financial relationships with manufacturers are appropriate. Professional organizations make important policy contributions guided by informed members who have a nuanced understanding of the potential problems and reasonable boundaries of their colleagues’ work with industry. Implementation of these guidance documents will depend on local oversight, as exemplified by institutional committees adjudicating ethical decisions about research, animal care, and conflict of interest. Public knowledge and respect for these activities can be strengthened by discussion in the popular media.
Publicity about the management of potential conflicts of interest at the local level can help convince the public that the profession is fulfilling its obligation to society. For example, public knowledge of the practice of surgeons who forego royalties on devices of their own invention when operating on their personal patients will strengthen public confidence in the integrity of the profession. Reference to approval by appropriate institutional committees has replaced the previous detailed description of the precautions and conditions required for ethical research involving animals or human subjects. It is possible that a similar statement by an oversight committee demonstrating that there is no conflict of interest between surgeons and manufacturing companies would simplify the process of informing patients about these relationships and eliminate the necessity of providing detailed explanations. The legislated proposal of a publicly accessible web site listing all industry contributions to surgeons3 offers an opportunity for the profession to identify those surgeons and relationships that meet or exceed the Standards of Professionalism of the AAOS4.
Our study had several limitations. We included only postoperative patients because we thought this research did not justify the risk of undermining patients’ trust in their surgeon’s commitment to their best interests preoperatively. We reasoned that postoperative patients have the experience and knowledge to advise on what information would have been helpful to them preoperatively. Because the patients in our study tended to be well educated and financially secure, our findings may not apply to all orthopaedic surgical patients.
We did not expose the study participants to the full range of reported distortions of the fiduciary obligations of both surgeons and manufacturers that affect the marketing and practice of prosthetic treatment. For example, we did not specifically explore payments from manufacturers to surgeons strictly tied to the use of a particular implant. Based on other items in the questionnaire, we feel that patient opinion regarding this practice could be confidently inferred. In order to maximize survey participation and minimize item nonresponse rates, we had to limit the length of the questionnaire. We therefore did not explore patients’ level of understanding of financial relationships between surgeons and manufacturers, nor did we explore the dollar value at which particular financial relationships become inappropriate.
This is an empirical study of the views of patients about a limited part of the spectrum of surgeons’ financial relationships with industry. We hope that the views expressed by these patients will help to reinforce and strengthen the trustworthiness that has characterized the orthopaedic profession and its relationship with our industry partners.
The survey instrument used in this study is available with the online version of this article as a data supplement at jbjs.org.
Note: The authors thank Trudo Lemmens, Jane MacIver, Paula McCree, Rahim Moineddin, Emil Schemitsch, Ross Upshur, and Fiona Webster for their input into study design and analysis. The authors thank the contributing surgeons: James Bono, Hugh Cameron, John Cameron, Jeffrey Gollish, Richard Jenkinson, John Murnaghan, Oleg Safir, Carl Talmo, Geoffrey Van Flandern, Veronica Wadey, Daniel Ward, and Stewart C. Wright. The authors are grateful for the essential contribution of the patients who participated in this study.
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Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. One or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.