What do patients undergoing hip, knee or spine surgery think about the relationship between their surgeon and medical device companies? Do they believe their physician will choose an implant based on the patient’s best interest or to the best interest of the physician’s pocketbook?
A survey of 1, 000 patients from the Mayo Clinic conducted by Scott McGovern, M.D., between 2003 and 2007, found that the vast majority of patients believe that surgeon/industry relations are beneficial for their care. Nearly all patients believe their surgeon will choose the implant that is best for them.
However, there was one noteworthy statistic.
Approximately one quarter of patients tended to agree with the statement that physician’s choice of implant was based upon the potential for personal financial gain of the physician.
Commenting on the percentage, McGovern told us, “We surveyed patients and asked difficult questions to determine their perception of our decision process in choosing implants for surgery. Ninety-five (95%) [percent] of patients believe that their doctor will choose the best implant for them.”
Scott McGovern, M.D.“Mayo Clinic instituted a written disclosure statement shortly after the time of the surveyed population in 2008 to disclose that doctors do not receive any additional reimbursement or royalties for implants for surgery performed at our institution. We believe this disclosure helps to alleviate patient anxiety about financial decisions for implant choice.”
McGovern said that the clinic’s written disclosure guidelines and other practices are designed to demonstrate to patients that their particular surgical needs are not only superior to the physician’s financial situation but are the only needs being considered.
The Social Contract
The physician/patient relationship rests upon one of society’s oldest social contracts first articulated by Hippocrates.
The patient’s perception and expectation is that the physician will act in the patient’s best interest. That perception is the foundation that gives each patient the confidence to literally put their life into the hands of the physician. It also conveys upon the physician enormous power in determining the course of care for that patient.
Now, shifting gears slightly but still keeping the patient in mind, physicians and industry engineers must collaborate in order to develop and produce improved instruments and devices—again, for the benefit of the patient. This activity also carries with it a financial benefit—for the inventor/physician, consulting physician and manufacturer. It is, as is well known, the financial component of this collaboration that has generated concerns regarding surgeon conflicts of interests and their role in patient care. Finally, those concerns are finding expression in the form of legislation generally and more specifically, the recently enacted Patient Sunshine Act.
First Data
Until now, there has been little, if any, data which purports to measure patient attitudes and opinions regarding surgeon relationships with industry. What, for example, is the patient’s perception of surgeon/industry relationships and have they changed patient’s attitudes and is the trust basis of the physician/patient relationship changing?
McGovern and his colleagues, Robert Trousdale, M.D. and Bradford Currier, M.D., surveyed 1, 000 patients who were at the Mayo Clinic to undergo hip, knee or spine surgery.
Two groups of patients representing primary total joint arthroplasty and instrumented spinal surgery were randomly selected from the overall population of patients undergoing primary total hip, total knee or instrumented spinal fusions. The two groups of patients were then matched with cohorts of non-surgical patients during the same time period with correlating diagnoses.
Four equal groups of 996 patients were then mailed the surveys. Survey responders had an average age of 66 years. Fifty-one percent (51%) of the responders were male. Forty-two (42%) percent were spine patients while the remaining were hip and knee patients. Two-thirds of responders had prior surgery with implants, and of these 80% characterized their outcomes as either very good or excellent.
McGovern told us that he decided to perform the survey because recent concern generated in the media, legal and scientific communities have been “alarming to physicians.” He said the authors recognized that the patients perceptions on the surgery performed was not defined and they sought to inquire about this as well as comparing responses from surgical and non-surgical patients.
Legitimate Collaboration, Trust and Choice
The vast majority (93%) of patients believe that it is beneficial for doctors to advise manufacturers of surgical implants. However, only one-third believe that surgeon-owned device companies are appropriate and beneficial to their care.
While 82% of patients said the physicians should be compensated for helping to design new implants, less than half that number (41%) of patients believed that physicians should receive compensation for only offering advice to the companies. That number dropped to 33% when the patients identified themselves as someone who works in the healthcare field. Ten percent (10%) of patients believed physicians should receive additional payment for each implant used.
Eighty-five (85%) percent of patients believe their doctor chooses implants based upon either familiarity/personal preference, or medical research.
Seven (7%) percent tended to agree that hospital or insurers should have the sole choice of implant. Fifty-six (56%) percent believe doctors should have the sole choice of implant, and 26% tended to agree that patients should have sole choice of implant.
More Trusting the Second Time Around
Patients who had undergone previous surgery were more trusting of physicians.
Twenty-six (26%) percent of patients who had undergone prior surgery tended to disagree that physicians should receive financial reimbursement for an advisory role alone, while slightly fewer than half of patients (44%) without prior surgery tended to disagree.
While the large majority of patients without prior surgical implants (80%) tended to agree that doctors should disclose this relationship, only 68% of surgical patients with prior surgical implants tended to agree that doctors should tell patients of this relationship.
The vast majority of surgical patients (91%) tended to trust their doctor to put the patient’s medical needs above all other considerations compared to 83% of nonsurgical patients. While slightly more than half of non-surgical patients (52%) believe that what their doctor tells them must be true, two-thirds of patients with prior surgery tended to agree that what their doctor tells them must be true. A large majority of patients with prior surgery (88%) believe their physician is an expert in musculoskeletal care, while slightly more than half of patients without prior surgery (52%) tended to agree.
Marketing and Promotion
With respect to marketing of surgical implants, only one-third of patients believe that doctors should help promote the implants they helped design. Seventy-seven (77%) percent were aware that private companies manufacture implants for surgery and over half of patients have seen advertisements for surgical implants. Slightly less than one quarter (24%) of patients tended to agree that private companies should advertise directly to consumers. Most patients (65%) believe private companies should advertise directly to physicians.
Gender and Educational Level
Males prefer more disclosure. More than three-quarters of male patients tended to agree that doctors should tell patients about a financial relationship versus only two-thirds of female patients. The vast majority of male patients (92%) believe their doctor is considerate of their needs versus 82% of female patients.
Ninety-five (95%) percent of patients with higher education (college or more) tended to agree more strongly than less educated patients (89%) that it is beneficial for doctors to advise manufacturers.
Less than one-third of patients with higher education level (31%) believe surgeon-owned medical device companies are appropriate and beneficial to their care while greater than one-third (38%) of less educated patients.
Strengthening the Social Contract
The authors of the study noted that there is a clear concern among patients for physician-owned device manufacturers as well as surgeons promoting the devices he or she has helped design. “These types of perceptions should be explored further and either potential conflict of interest managed differently or greater transparency and education for our patients may be needed, ” concluded the study.
McGovern told us that he hopes this study was successful in revealing patients’ perceptions of the surgeon/industry relations.
“With this information, physicians may alter disclosure practices to better inform patients of their role in design of implants. Surgeons and patients should recognize that potential conflict of interest occurs with surgeon involvement in the design and implantation of devices from private industry.
Patients demonstrate a strong trust in physicians, whether or not they have had prior surgery. Surgeons must ensure that potential conflict of interest is managed in a transparent and ethical manner to preserve this trust.
If Dr. McGovern is right, his work may well help strengthen that fraying social contract between patients and physician.
To read the entire results of the survey, please click here: https://ryortho.com/McGovernPatientPercepDocsInd.pdf.
