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Conflict of Interest in Seminal Hepatitis C Virus and Cholesterol Management Guidelines

Akilah A Jefferson1, Steven D Pearson2

  • 1Clinical Center, Department of Bioethics, National Institutes of Health, Bethesda, Maryland.

JAMA Internal Medicine
|January 24, 2017
PubMed

Insights

Neither cholesterol nor hepatitis C guidelines fully met Institute of Medicine (IOM) conflict of interest (COI) standards. Discrepancies in disclosed COI were common, impacting guideline trustworthiness.

Area of Science:

  • Medical Guidelines
  • Conflict of Interest Management
  • Clinical Practice Standards

Background:

  • Institute of Medicine (IOM) standards provide a framework for managing conflicts of interest (COI) in clinical guideline development.
  • Adherence to these standards is crucial for ensuring the objectivity and trustworthiness of clinical recommendations.
  • Little is known about the extent to which recent, influential clinical guidelines meet these IOM COI standards.

Purpose of the Study:

  • To evaluate adherence to the IOM standards for managing commercial conflicts of interest (COI) in guideline development.
  • To assess compliance with IOM standards for evidence evaluation in clinical guidelines.
  • To examine the 2013 ACC/AHA cholesterol guideline and the 2014 AASLD/IDSA hepatitis C guideline for IOM standard adherence.

Main Methods:

  • Retrospective document review of the 2014 cholesterol and 2015 hepatitis C guidelines.
  • Assessment of adherence to IOM standards for commercial COI, including limits on committee members and chairs.
  • Review of guideline disclosures and contemporaneous article disclosures to identify all commercial COIs.

Main Results:

  • The cholesterol guideline had 44% of members with commercial COI, including industry-sponsored research and consultancy. One of three chairs/cochairs disclosed COI.
  • The hepatitis C guideline had 72% of members with commercial COI, with significant industry research, advisory, and consultancy roles. Four of six cochairs disclosed COI, with additional undisclosed COI found in other publications.
  • The cholesterol guideline met 56% of IOM development and evidence standards, while the hepatitis C guideline met all.

Conclusions:

  • Neither guideline fully adhered to IOM standards for commercial COI management.
  • Discordance between disclosed COI in guidelines and contemporaneous articles was frequent.
  • Mixed adherence to other IOM standards suggests a need for consistent COI frameworks in specialty societies for transparent guideline development.
Abstract

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