Abstract
BackgroundLittle research has examined how physicians choose medical devices for treating individual patients to reveal if interventions are needed to support decision-making and reduce device-associated morbidity and mortality. This study explored factors that influence choice of implantable device from among available options.MethodsA descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites. They were asked how they decided what device to use in a given patient, sources of information they consulted, and how patients were engaged in decision-making. Sampling was concurrent with data collection and analysis to achieve thematic saturation. Data were analyzed using constant comparative technique by all members of the research team.ResultsTwenty-two physicians from five Canadian provinces (10 cardiovascular, 12 orthopedic; 8, 10 and 4 early, mid and late career, respectively) were interviewed. Responses did not differ by specialty, geographic region or career stage. Five major categories of themes emerged that all influence decision-making about a range of devices, and often compromise choice of the most suitable device for a given patient, potentially leading to sub-optimal clinical outcomes: lack of evidence on device performance, patient factors, physician factors, organizational and health system factors, and device and device market factors. In the absence of evidence from research or device registries, tacit knowledge from trusted colleagues and less-trusted industry representatives informed device choice. Patients were rarely engaged in decision-making. Physician preference for particular devices was a barrier to acquiring competency in devices potentially more suitable for patients. Access to suitable devices was further limited to the number of comparable devices on the market, local inventory and purchasing contract specifications.ConclusionsThis study revealed that decision-making about devices is complex, cognitively challenging and constrained by several factors limiting access to and use of devices that could optimize patient outcomes. Further research is needed to assess the impact of these constraints on clinical outcomes, and develop interventions that optimize decision-making about device choice for treating given patients.
Highlights
Little research has examined how physicians choose medical devices for treating individual patients to reveal if interventions are needed to support decision-making and reduce device-associated morbidity and mortality
The purpose of this study was to explore factors that influence individual physician decision-making about choice of implantable medical device from among options available to treat a given patient, and identify factors that may constrain choice and potentially compromise clinical outcomes, which should be targeted in the future through policies or behavioral interventions
This study revealed the complexity of medical decision-making to choose devices, which is constrained by the cognitive challenge of acquiring, verifying and integrating knowledge from various sources and tailoring it for individual patients, and further constrained by several factors limiting access to and use of devices that could optimize patient outcomes
Summary
Little research has examined how physicians choose medical devices for treating individual patients to reveal if interventions are needed to support decision-making and reduce device-associated morbidity and mortality. Studies analyzing the quality of research for frequently emerging new versions of medical devices found they are marketed without the rigorous scientific evidence expected for drug approval and, adverse medical device events may only emerge when they are used in patients [5, 6]. Given the potential risks associated with medical devices, and variable evidence of their safety and effectiveness, there is a need for greater insight on how physicians choose devices that optimize patient treatment and outcomes from among the available options
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