Experiences With a Novel Policy for Managing Conflicts of Interest of Guideline Developers

Abstract

Background The executive committee of the Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (AT9) developed a novel policy for managing conflicts of interest (COIs): Methodologists bore primary responsibility for each chapter, there was equal emphasis on intellectual and financial COI, and content experts with COIs participated, but with restrictions for recommendations on which they had conflicts. The objective of this study was to explore the experiences of the methodologists and content experts with the COI policy after its implementation. Methods One investigator conducted two rounds of semistructured interviews with the methodologist and the leading content expert of each chapter until data saturation was achieved. Two investigators analyzed the transcripts of the interviews in duplicate using an immersion-crystallization approach. We also conducted member checking. Results We interviewed 15 participants and presented the results to the remaining four for verification. In comparison with their views expressed prior to AT9 development, methodologists remained more positive about the policy than content experts. Six of 10 content experts expressed a more positive view than prior to participation in the AT9 process. The other four content experts remained skeptical, especially regarding the emphasis on intellectual COI. The restrictions of the policy on conflicted individuals were not fully implemented. Conclusions After its implementation, some content experts were more favorable to the policy, but some retained major reservations. The influence of the policy on recommendations may have been more through the leading role of the methodologists than exclusion of conflicted participants in making recommendations. The executive committee of the Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (AT9) developed a novel policy for managing conflicts of interest (COIs): Methodologists bore primary responsibility for each chapter, there was equal emphasis on intellectual and financial COI, and content experts with COIs participated, but with restrictions for recommendations on which they had conflicts. The objective of this study was to explore the experiences of the methodologists and content experts with the COI policy after its implementation. One investigator conducted two rounds of semistructured interviews with the methodologist and the leading content expert of each chapter until data saturation was achieved. Two investigators analyzed the transcripts of the interviews in duplicate using an immersion-crystallization approach. We also conducted member checking. We interviewed 15 participants and presented the results to the remaining four for verification. In comparison with their views expressed prior to AT9 development, methodologists remained more positive about the policy than content experts. Six of 10 content experts expressed a more positive view than prior to participation in the AT9 process. The other four content experts remained skeptical, especially regarding the emphasis on intellectual COI. The restrictions of the policy on conflicted individuals were not fully implemented. After its implementation, some content experts were more favorable to the policy, but some retained major reservations. The influence of the policy on recommendations may have been more through the leading role of the methodologists than exclusion of conflicted participants in making recommendations.