Background
Innovations in surgery, such as open-heart surgery, organ transplantation and minimally invasive procedures, continue to benefit patients worldwide. A surgical innovation can be defined as a new "
intervention that is not viewed by the institution, community or profession as meeting the accepted standards of safety, reliability and familiarity with effects, side effects and complications" [
1]. In an attempt to improve an existing technique, implement a new technology or enhance institutional productivity, surgical innovations are often introduced by individual surgeons under independent circumstances. As a result of this ad-hoc approach, no mechanism exists to capture and share what has been learned from these experiences [
2]. Decision-making processes for the adoption of surgical innovations have not been well studied, and a standard process for the introduction of surgical innovations in hospitals does not exist.
The demand for less invasive approaches to surgical procedures by patients, health care institutions, and industry, places increased pressure on surgeons to acquire the appropriate skills to adopt innovative procedures. Pressure to adopt new technologies within departments can make decision-making for these innovations challenging. Individual surgeons are usually not in a position to make judgments about collective resource allocation, and may exert pressure for the implementation of innovations outside the usual institutional decision-making process. Surgeons often adopt new technologies into practice despite poor evidence regarding the efficacy of an innovation [
3]. Even when evidence supports an innovation, practitioners may not always choose to adopt it. For example, percutaneous transluminal coronary angioplasty (PTCA), an alternative to coronary artery bypass grafting that relieves narrowing and obstruction of the coronary arteries, experienced slow adoption rates in some hospitals despite strong supporting evidence [
4].
With the emergence and rapid diffusion of new surgical technologies, there is an increasing need to prioritize and contain costs to ensure the sustainability of the health care system [
2,
5,
6]. In addition to requiring that treatments have some scientifically sound basis, [
7], public accountability is an important consideration when resources might be diverted from other causes [
8]. Decision-makers in Canadian healthcare institutions must balance the benefits of using a new technology against cost and risk to patient safety, in a context where reliable data are scarce. In other words, a method of priority setting is required for the adoption of new surgical technologies [
9].
Priority setting is a challenge for every health care system because demand for health services outweighs available resources. As a result, hospital decision-makers are forced to set priorities for providing access to health care services. In every health system, decision-makers must ensure that they achieve two key goals in priority setting: legitimacy, defined as the moral authority to make allocation decisions about available resources [
10]; and fairness, which is achieved when an individual has sufficient reason to accept a priority setting decision because of the acceptability of the decision-making process [
11]. Legitimacy and fairness are related in that decision-makers' legitimacy may be enhanced by their commitment to the use of a fair decision-making process. Before evaluating the legitimacy and fairness of priority setting, it is beneficial to first understand how these decisions are currently made [
12]. Understanding these experiences will provide insight on the varying adoption patterns and provide guidance for addressing the challenge of priority setting in surgery. Surgical innovations face different challenges than other healthcare innovations such as pharmaceutical agents. For example, there is less government regulation of surgical procedures and devices than drugs, and there may be greater budgetary constraints and lack of research to support surgical procedures and devices. Until now, decision-making processes for adopting surgical innovations have not been well studied.
The purpose of this paper is to describe and evaluate the adoption of a new health technology used by surgeons for the treatment of aortic aneurysms called endovascular aneurysm repair (EVAR). This surgical innovation posed unique economic and ethical challenges for the institution. Results from this study will contribute to the development of guidelines to help decision-makers in relation to future surgical innovations in Canadian hospitals.
Discussion
Surgical innovations are driven in large measure by a surgeon's desire to innovate and improve health care. Consequently, patients with major medical conditions who would have been deemed inoperable in the past are now candidates for interventions due to the decreased risk associated with some surgical innovations. On the other hand, patients face risks when new surgical technologies are introduced. There is a fine line between 'innovation' and 'experimentation'. Moreover, surgical innovations may have significant resource implications for individual institutions and the entire health care system. Therefore, there is a role for oversight of even well-intentioned decision-making by surgeons [
28].
How a surgical technology is valued by a hospital depends on many factors. EVAR posed a large economic impact on the institution. The institution's views on the innovation and its effectiveness differed from that of the providers. The conflicting values evident in the decisions made affected the vascular surgery division, resulting in the recruitment and subsequent loss of a vascular surgeon. Furthermore, patients were exposed to a procedure with unestablished outcomes. Conflicting values existed between the surgeons and hospitals. Surgeons were interested in bringing the 'newest' and 'best' technologies to their patients, and did not describe being heavily influenced by their cost. Hospitals want to provide health services within their constrained resources. These conditions highlight the importance of developing a fair process for the evaluation of future innovations in surgery.
Accountability for Reasonableness is a framework that has been used to evaluate priority setting at both the hospital level and at the level of clinical programs such as cardiac surgery [
29,
30], but has not been used to focus specifically on decisions to adopt surgical innovations at the level of a surgeon or surgical department.
Accountability for Reasonableness provides an explicit framework to evaluate this process and describe good practices and recommendations for improvement that can be used to help inform the development of guidelines to aid decision-makers in the adoption of future surgical innovations at the hospital level.
The decision to adopt EVAR was driven by a few individuals interested in adopting the new technology focusing on a very narrow range of factors. Communication was made with a hospital decision-maker and the Research Ethics Board to inform them of the procedure prior to adoption, however other departments that were affected should have been engaged in this process (such as the radiology department). Communication occurred primarily among the members of the vascular surgery department. Greater involvement from administration to identify financial constraints would have been beneficial to help avoid stopping EVAR once it began. A key hospital decision-maker at the time was a vascular surgeon, which may have posed a conflict of interest in the decision. On the other hand, it is possible that this decision-maker had better knowledge about the value of EVAR at a time when other stakeholders were less enthusiastic about its value.
A mechanism to ensure competence was used by recruiting a surgeon from another hospital with prior experience with EVAR. This reduced the learning curve associated with acquiring a new skill for an innovation [
31], presumably increasing the success and safety of the performance of the procedure. However, according to the
Accountability for Reasonableness framework, the decision to adopt and the decision to stop EVAR were not made fairly.
The decision to adopt EVAR was based on perceived improved patient outcomes and safety and the surgeons' desire to innovate. The decision-making process responsible for this adoption followed mainly the "medical-individualistic" perspective [
32] which focuses on hospitals adopting new technologies based on the clinical needs of their patient population and the benefit of the intervention for the patient. This decision is driven by the clinician or hospital medical administrator regardless of whether economic considerations or other factors suggest alternative decisions [
33]. Greenberg et al (2005) found that most adoption decisions for new technologies come from senior physicians, but the responsibility for the final adoption decisions varies depending on the technology. For innovations that involve large capital investments, the final decision was usually made by the hospital's senior executives, or by ad hoc committees consisting of similar administrative and medical leaders [
33].
There was very little medical evidence available in the literature at the time, and there were no long-term data available due to the novelty of the procedure. Based on the surgeon's desire to help their patients who they felt, in many cases, had few other options, this was seen as a logical choice and therefore offered to their patients. However, this decision involved few stakeholders – other departments that were affected were not engaged at the time. Furthermore, hospital decision-makers were not adequately informed, which later had an impact on the decision to stop funding the procedure.
The decision to stop funding involved all key players and was based on criteria apparent to all those involved, including cost, evidence and hospital priorities. In light of the conceptual framework used in this study, the initial decision to introduce the technology did not satisfy two of the conditions of Accountability for Reasonableness, however, the decision to terminate it did. It is interesting that a poor process can produce what, in retrospect, appeared to be a 'good' decision and that a 'good' process does not guarantee that a 'good' decision will be the result.
Several lessons can be learned from this analysis. In order to improve the decision-making process, hospitals should develop a structure for deliberating the reasons for adopting a surgical innovation. This recommendation is consistent with other studies of technology adoption at the hospital level where a centralized process should be established with a medical director involvement [
33,
34]. The process should involve a wide range of stakeholders including managers, a financial officer from the institution with oversight of hospital budget, some representation from the public, community member, department head and other departments affected to allow the full range of relevant considerations to be included. Furthermore, broader input should be sought, not solely from individuals personally invested in the innovation. A 'disinterested' person, one at 'arms length' to the advocates of the innovation, would have the appearance of being less biased in favour of its adoption.
Hospitals should also establish a formal appeals mechanism for addressing challenges to the decisions being made [
35]. This may have facilitated discussions between radiologists and the surgeons, improving the quality of communication between key stakeholders. This should not be regarded as a dispute resolution mechanism as much as a mechanism for improving the quality of decisions being made (see Table
2). Structures that currently exist in hospitals that may act as an appeals mechanism might include department heads, advisory committees or ethics boards. While these individuals or groups may assist in such decisions, their role is not mandated or structured. To ensure consistency and fairness in such decision-making processes, it is important to establish a structure that can address such issues for surgeons and their teams.
Table 2
Recommendations for improving the decision-making process
1. Hospitals should develop a structure for deliberating the reasons for adopting a surgical innovation that involve a wide range of stakeholders. |
2. Broader input should be sought from individuals involved with the procedure and those at "arms length" who may not be directly invested in the innovation. |
3. Hospitals should establish a formal appeals mechanism for addressing challenges to the decisions being made. |
Our study has several limitations. The results from this case study represent findings from an academic health sciences centre, which may not be generalizable to smaller community hospitals. The goal of qualitative research however, is to provide a rich description of a context-specific phenomenon derived from empirical research. It would be useful to study different types of surgical innovations using the same framework and in different settings. The small sample size may be considered a limitation, however, we interviewed all the individuals who were involved in the process at the time and those who had experience with the innovation. This small number represents all the key players as identified through our sampling strategy.
A challenge presented throughout the interview process was the respondents' recall of past events, and their perceptions at the time of implementation. Since we were asking opinions of events that occurred several years ago, some of the recalled details may be inaccurate. We did, however, obtain consistent information from the different respondents, in addition to document analyses that corroborated information from key informant interviews, suggesting that respondents' representations were valid.
Competing interests
The author(s) declare that they have no competing interests.
Authors' contributions
ND conducted the interviews, performed data analysis and drafted the manuscript. DM participated in the design of the study. PL participated in the design of the study and data analysis. JH participated in the interview process and data analysis. RS participated in the design of the study. MB participated in the design of the study. DU conceived of the study, participated in its design and coordination and helped draft the manuscript. All authors read, reviewed and approved the final manuscript.