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Published on: February 16, 2011
Experiences with a novel policy for managing conflicts of interest of guideline developers: a descriptive qualitative
Ignacio Neumann1, Renee Karl2, Aman Rajpal3
1Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada; Department of Internal Medicine, School of Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile.
Insights
Methodologists generally favored the new conflict of interest (COI) policy, while content experts had mixed reactions. The policy
Area of Science:
- Medical Guidelines Development
- Conflict of Interest Management
- Evidence-Based Practice
Background:
- The Antithrombotic Therapy and Prevention of Thrombosis (AT9) guidelines introduced a novel conflict of interest (COI) policy.
- This policy emphasized methodologist responsibility, equal consideration of intellectual and financial COIs, and restricted conflicted experts' roles in recommendations.
Purpose of the Study:
- To explore the experiences of methodologists and content experts with the AT9 COI policy after its implementation.
Main Methods:
- Semistructured interviews were conducted with methodologists and leading content experts until data saturation.
- Interview transcripts were analyzed in duplicate using an immersion-crystallization approach.
- Member checking was performed for result verification.
Main Results:
- Methodologists generally held a more positive view of the policy compared to their pre-AT9 perspectives.
- Content experts showed mixed reactions: 60% became more positive, while 40% remained skeptical, particularly about intellectual COI emphasis.
- The policy's restrictions on conflicted individuals were not consistently implemented.
Conclusions:
- Some content experts developed a more favorable view of the COI policy, but significant reservations persisted.
- The policy's impact on recommendations may stem more from the methodologists' leadership than the exclusion of conflicted experts.
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.
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