"We can't get along without each other": Qualitative interviews with physicians about device industry representatives, conflict of interest and patient safety.

Anna R Gagliardi,Chaim Bell,David R Urbach,Pascale Lehoux,Sue Ross,Ariel Ducey,Anthony Easty,Patricia Trbovich,Angel M Foster

doi:10.1371/journal.pone.0174934

Abstract

ObjectivesPhysician relationships with device industry representatives have not been previously assessed. This study explored interactions with device industry representatives among physicians who use implantable cardiovascular and orthopedic devices to identify whether conflict of interest (COI) is a concern and how it is managed.DesignA descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites, and interviewed about their relationships with device industry representatives. Sampling was concurrent with data collection and analysis. Data were analyzed and discussed using constant comparative technique by all members of the research team.ResultsTwenty-two physicians (10 cardiovascular, 12 orthopedic) were interviewed. Ten distinct representative roles were identified: purchasing, training, trouble-shooting, supplying devices, assisting with device assembly and insertion, supporting operating room staff, mitigating liability, conveying information about recalls, and providing direct and indirect financial support. Participants recognized the potential for COI but representatives were present for the majority of implantations. Participants revealed a tension between physicians and representatives that was characterized as “symbiotic”, but required physicians to be vigilant about COI and patient safety, particularly because representatives varied regarding disclosure of device defects. They described a concurrent tension between hospitals, whose policies and business practices were focused on cost-control, and physicians who were required to comply with those policies and use particular devices despite concerns about their safety and effectiveness.ConclusionsGiven the potential for COI and threats to patient safety, further research is needed to establish the clinical implications of the role of, and relationship with device industry representatives; and whether and how hospitals do and should govern interaction with representatives, or support their staff in this regard.

Highlights

Conflict of interest (COI) has been defined as “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest” [1,2]
Participants revealed a tension between physicians and representatives that was characterized as “symbiotic”, but required physicians to be vigilant about COI and patient safety, because representatives varied regarding
Device industry representatives disclosure of device defects. They described a concurrent tension between hospitals, whose policies and business practices were focused on cost-control, and physicians who were required to comply with those policies and use particular devices despite concerns about their safety and effectiveness

Summary

Introduction

Conflict of interest (COI) has been defined as “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest” [1,2]. Disclosure policies are the most commonly applied strategy to address COI [6,7,8]. Analysis of COI policies at American [11] and Canadian [12] universities and research institutions found that, while the majority had COI policies, they varied in criteria for what to disclose and how to manage COI. Limitation is another strategy for managing COI whereby organizations such as hospitals apply policies that prohibit employees from accepting industry incentives, or restrict visits from industry representatives [13]. Despite the presence of such limitation policies, physicians who were interviewed said that they trusted and valued information from drug industry representatives, and felt that it benefited patients [14,15]

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