Patient-reported Limitations to Surgical Buy-in: A Qualitative Study of Patients Facing High-risk Surgery.

OBJECTIVE: To characterize how patients buy-in to treatments beyond the operating room and what limits they would place on additional life-supporting treatments. BACKGROUND: During a high-risk operation, surgeons generally assume that patients buy-in to life-supporting interventions that might be necessary postoperatively. How patients understand this agreement and their willingness to participate in additional treatment is unknown. METHODS: We purposively sampled surgeons in Toronto, Ontario, Boston, Massachusetts, and Madison, Wisconsin, who are good communicators and routinely perform high-risk operations. We audio-recorded their conversations with patients considering high-risk surgery. For patients who were then scheduled for surgery, we performed open-ended preoperative and postoperative interviews. We used directed qualitative content analysis to analyze the interviews and surgeon visits, specifically evaluating the content about the use of postoperative life support. RESULTS: We recorded 43 patients' conversations with surgeons, 34 preoperative, and 27 postoperative interviews. Patients expressed trust in their surgeon to make decisions about additional treatments if a serious complication occurred, yet expressed a preference for significant treatment limitations that were not discussed with their surgeon preoperatively. Patients valued the existence or creation of an advance directive preoperatively, but they did not discuss this directive with their surgeon. Instead they assumed it would be effective if needed and that family members knew their wishes. CONCLUSIONS: Patients implicitly trust their surgeons to treat postoperative complications as they arise. Although patients may buy-in to some additional postoperative interventions, they hold a broad range of preferences for treatment limitations that were not discussed with the surgeon preoperatively.

Patient views on financial relationships between surgeons and surgical device manufacturers.

BACKGROUND: Over the past decade, revelations of inappropriate financial relationships between surgeons and surgical device manufacturers have challenged the presumption that surgeons can collaborate with surgical device manufacturers without damaging public trust in the surgical profession. We explored postoperative Canadian patients' knowledge and opinions about financial relationships between surgeons and surgical device manufacturers. METHODS: This complex issue was explored using qualitative methods. We conducted semistructured face-to-face interviews with postoperative patients in follow-up arthroplasty clinics at an academic hospital in Toronto, Canada. Interviews were audiotaped, transcribed and analyzed. Patient-derived concepts and themes were uncovered. RESULTS: We interviewed 33 patients. Five major themes emerged: 1) many patients are unaware of the existence of financial relationships between surgeons and surgical device manufacturers; 2) patients approve of financial relationships that support innovation and research but are opposed to relationships that involve financial incentives that benefit only the surgeon and the manufacturer; 3) patients do not support disclosure of financial relationships during the consent process as it may shift focus away from the more important risks; 4) patients support oversight at the professional level but reject the idea of government involvement in oversight; and 5) patients entrust their surgeons to make appropriate patient-centred choices. CONCLUSION: This qualitative study deepens our understanding of financial relationships between surgeons and industry. Patients support relationships with industry that provide potential benefit to current or future patients. They trust our ability to self-regulate. Disclosure combined with appropriate oversight will strengthen public trust in professional collaboration with industry.

CONTEXTE: Ces 10 dernières années, la mise en lumière de relations financières inappropriées entre des chirurgiens et des fabricants de matériel chirurgical a remis en doute la capacité des chirurgiens à collaborer avec les fabricants et ébranlé la confiance du public en la profession. Nous avons étudié ce que les patients canadiens ayant récemment été opérés pensent et connaissent des relations financières entre les chirurgiens et les fabricants de matériel chirurgical. MÉTHODES: Nous avons mené une étude qualitative portant sur cette question complexe au moyen d'entrevues semi-dirigées effectuées en personne avec des patients qui assistaient, dans un hôpital universitaire de Toronto (Canada), à des rencontres postopératoires à la suite d'une arthroplastie. Les entrevues ont été enregistrées, transcrites, puis analysées, ce qui a mis au jour des notions et des thèmes issus des patients. RÉSULTATS: Nous avons interrogé 33 patients et dégagé 5 grandes conclusions : 1) de nombreux patients ignorent l'existence de relations financières entre les chirurgiens et les fabricants de matériel chirurgical; 2) les patients acceptent les relations financières qui soutiennent l'innovation et la recherche, mais rejettent celles qui ne profitent qu'aux chirurgiens et aux fabricants; 3) les patients ne veulent pas que les relations financières soient divulguées pendant le processus de consentement, car une telle divulgation pourrait détourner l'attention des risques plus importants; 4) les patients sont d'accord pour qu'une surveillance soit exercée par l'ordre professionnel, mais pas par le gouvernement; 5) les patients font confiance aux chirurgiens et croient qu'ils font des choix axés sur leurs patients. CONCLUSION: Cette étude qualitative approfondit notre compréhension des relations financières entre les chirurgiens et les autres acteurs du domaine. Les patients soutiennent ce type de relations pourvu qu'elles puissent profiter aux patients actuels et futurs, et croient en notre capacité d'autoréglementation. Ensemble, la divulgation de ces relations et une surveillance appropriée renforceront la confiance du public en la collaboration entre les professionnels et les entreprises.

"And I think that we can fix it": mental models used in high-risk surgical decision making.

OBJECTIVE: To examine how surgeons use the "fix-it" model to communicate with patients before high-risk operations. BACKGROUND: The "fix-it" model characterizes disease as an isolated abnormality that can be restored to normal form and function through medical intervention. This mental model is familiar to patients and physicians, but it is ineffective for chronic conditions and treatments that cannot achieve normalcy. Overuse may lead to permissive decision making favoring intervention. Efforts to improve surgical decision making will need to consider how mental models function in clinical practice, including "fix-it." METHODS: We observed surgeons who routinely perform high-risk surgery during preoperative discussions with patients. We used qualitative content analysis to explore the use of "fix-it" in 48 audio-recorded conversations. RESULTS: Surgeons used the "fix-it" model for 2 separate purposes during preoperative conversations: (1) as an explanatory tool to facilitate patient understanding of disease and surgery, and (2) as a deliberation framework to assist in decision making. Although surgeons commonly used "fix-it" as an explanatory model, surgeons explicitly discussed limitations of the "fix-it" model as an independent rationale for operating as they deliberated about the value of surgery. CONCLUSIONS: Although the use of "fix-it" is familiar for explaining medical information to patients, surgeons recognize that the model can be problematic for determining the value of an operation. Whether patients can transition between understanding how their disease is fixed with surgery to a subsequent deliberation about whether they should have surgery is unclear and may have broader implications for surgical decision making.

It's big surgery: preoperative expressions of risk, responsibility, and commitment to treatment after high-risk operations.

OBJECTIVE: To identify the processes, surgeons use to establish patient buy-in to postoperative treatments. BACKGROUND: Surgeons generally believe they confirm the patient's commitment to an operation and all ensuing postoperative care, before surgery. How surgeons get buy-in and whether patients participate in this agreement is unknown. METHODS: We used purposive sampling to identify 3 surgeons from different subspecialties who routinely perform high-risk operations at each of 3 distinct medical centers (Toronto, Ontario; Boston, Massachusetts; Madison, Wisconsin). We recorded preoperative conversations with 3 to 7 patients facing high-risk surgery with each surgeon (n = 48) and used content analysis to analyze each preoperative conversation inductively. RESULTS: Surgeons conveyed the gravity of high-risk operations to patients by emphasizing the operation is "big surgery" and that a decision to proceed invoked a serious commitment for both the surgeon and the patient. Surgeons were frank about the potential for serious complications and the need for intensive care. They rarely discussed the use of prolonged life-supporting treatment, and patients' questions were primarily confined to logistic or technical concerns. Surgeons regularly proceeded through the conversation in a manner that suggested they believed buy-in was achieved, but this agreement was rarely forged explicitly. CONCLUSIONS: Surgeons who perform high-risk operations communicate the risks of surgery and express their commitment to the patient's survival. However, they rarely discuss prolonged life-supporting treatments explicitly and patients do not discuss their preferences. It is not possible to determine patients' desires for prolonged postoperative life support on the basis of these preoperative conversations alone.

Patients' views on surgeons' financial conflicts of interest.

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.

Ethical considerations in aesthetic rhinoplasty: a survey, critical analysis, and review.

Although the practice of medicine is built on a foundation of ethics, science, and common sense, the increasing complexity of medical interventions, social interactions, and societal norms of behavior challenges the ethical practice of aesthetic surgeons. We report a survey of the opinions, practices, and attitudes of experienced and novice facial plastic surgeons. The survey consisted of 15 clinical vignettes addressing ethical quandaries in aesthetic rhinoplasty. The vignettes are based on the experience and observations of the senior author (P.A.A.) over nearly 30 years of practice and teaching. Fellowship directors and facial plastic surgery fellows of the American Academy of Facial Plastic and Reconstructive Surgery were surveyed anonymously. Five of the 15 vignettes demonstrated significant differences between the responses of the fellowship directors and the fellows. No single vignette had a unanimous consensus in either group. Aesthetic rhinoplasty surgeons encounter ethical issues that should be reflected on by both experienced and inexperienced facial plastic surgeons, preferably before being faced with them in practice. We present a practical approach to ethical issues in clinical practice. Our survey can also be used as a stimulus for further discussion and teaching.

The formal and informal surgical ethics curriculum: views of resident and staff surgeons in Toronto.

BACKGROUND: Understanding what staff surgeons think surgical trainees should learn and the ethical issues that trainees need to manage can strengthen surgical ethics education. METHODS: Participants were recruited from the 15 surgical specialty and subspecialty programs at the University of Toronto. Semistructured interviews and focus groups were conducted with 13 ethics coordinators from the surgical staff and 64 resident trainees. Data were analyzed qualitatively using modified thematic analysis. RESULTS: All coordinators and trainees felt that ethics education was an important component of surgical training. Real cases, varying teaching methods, and teachers with applicable clinical experience were valued. Trainees identified intraprofessional and interprofessional conflict, staff behavior perceived to be unethical, and their own lack of experience as challenging issues rarely addressed in the formal ethics curriculum. CONCLUSIONS: Ethics education is highly valued by trainees and teachers. Some ethical issues important to trainees are underrepresented in the formal curriculum. Staff surgeons and senior residents are practicing ethicists and role models whose impact on the moral development of residents is profound. Their participation in the formal curriculum helps less experienced junior residents realize its value.

Ethics in cardiothoracic surgery: a survey of surgeons' views.

BACKGROUND: Cardiothoracic surgeons are frequently confronted with complex ethical issues. Educational efforts to help surgeons navigate such issues have been undertaken in recent years, but their effectiveness is uncertain. METHODS: A survey instrument exploring the effects of ethics educational sessions at annual meetings and publications in cardiothoracic surgery journals was sent electronically to cardiothoracic surgeons who belong to The Society of Thoracic Surgeons and the American Association for Thoracic Surgery. RESULTS: Of 3,705 surgeons, 578 responded (15.6%). The majority of respondents practice in an academic setting (55%), attended at least two of the last five Society annual meetings (66%), and at least one of the last five Association annual meetings (68%). A majority of respondents agreed that their own practices would be improved (69%) and that cardiothoracic surgeons in general would benefit (83%) from better understanding of ethical issues. Respondents also believed that demonstration of an adequate understanding of ethical issues should be part of both American Board of Thoracic Surgery certification and maintenance of certification processes (61% and 60%, respectively). Among respondents who attended ethics presentations at annual meetings, only 4% believed that the sessions did not improve their understanding of complex ethical issues, and only 10% believed that the sessions did not affect their surgical practices. CONCLUSIONS: The survey suggested that efforts toward ethics education for cardiothoracic surgeons might be both relevant and important; the results encourage continuation and further improvement of such efforts.

Responding to trust: surgeons' perspective on informed consent.

BACKGROUND: Every day thousands of surgeons and patients negotiate their way through the complex process of decision-making about operative treatments. We conducted a series of qualitative studies, asking patients and surgeons to describe their experience and beliefs about informed decision-making and consent. This study focuses on surgeons' views. METHODS: Open-ended interviews and focus group discussions were conducted with thoracic surgeons who treated esophageal cancer patients by esophagectomy, and general surgeons who routinely performed laparoscopic cholecystectomy. Their views were analyzed using a qualitative approach, grounded in the perspectives of the participants. RESULTS: Five dominant themes emerged from the analysis: (1) making informed decisions; (2) communicating information and confidence; (3) managing expectations and fears; (4) consent as a decision to trust; (5) commitment inspired by trust. These themes are illustrated by verbatim quotes from the surgeon interviews. CONCLUSIONS: Surgeons carefully assess the risks and benefits of treatment before consenting to perform operative interventions. They are influenced by objective findings and by affective factors such as courage and the determination to survive expressed by their patients. They manage risks, doubts, and fears-both their patients' and their own-relying on trust and commitment on both sides to ensure the success of the surgical mission. The trust of their patients has a strong influence on the surgeons' decisions and actions.

The leap to trust: perspective of cholecystectomy patients on informed decision making and consent.

BACKGROUND: Although experts in ethics and law prescribe autonomous decision making as an essential component of informed consent to operative treatment, patients with esophageal cancer told us in a previous study that they preferred to entrust decision making to their caregivers in the context of life-threatening illness. The purpose of this study was to describe the patients' perspective on the process of informed decision making and consent to operative treatment in the context of a less frightening illness and intervention. STUDY DESIGN: Face-to-face interviews with 33 patients recovering from elective cholecystectomy for cholelithiasis were conducted at Toronto General Hospital in Ontario, Canada. The views of patients were analyzed using a qualitative approach. RESULTS: Patients described a spectrum of initial attitudes toward operative treatment ranging from profound distrust to unquestioning faith. Important factors influencing the decision to accept cholecystectomy included increasingly intolerable symptoms and fear of complications of the disease. Patients managed their doubts and fear by various means, without fully resolving them. CONCLUSIONS: In the context of symptomatic chronic cholelithiasis, pathways to consent for operative treatment originated at diverse, culturally determined starting points. Patients work their way through the decision process along many paths. Some rely on gathering information, but eventually all set aside unresolved residual doubts and fears, enabling a leap to trust and a decision to act.

Introducing new technologies: protecting subjects of surgical innovation and research.

The system for protecting human research subjects is under increasing pressure. Under the currently dominant Regulatory Ethics Paradigm, clinical research protocols must be reviewed and approved by an institutional review board (IRB) or equivalent. Although the IRB was introduced into health care in part to protect patients and investigators from the inherent conflict between the best clinical interest of the individual patient and the interest of science and society in answering a clinical question, its rigorous standards and rigid framework discourage surgeons from seeking potentially valuable early IRB consultation. Most of the important advances in the history of medicine, such as anesthesia, appendectomy, antibiotics, intensive care, and immunization, were introduced through an informal, unregulated innovation process that has been enormously productive but can lead to ratification of ineffective or harmful treatment by credulous physicians and patients. We propose a surgical innovation ethics paradigm that is a more nimble, flexible source of institutional and public oversight and approval of innovations that are in the gray zone prior to their conversion to formal protocols that then require IRB approval. We also discuss the management of personal and institutional conflicts of interest.