Conflict of Interest in Clinical Practice Guideline Development

Investigator: Lisa Bero, PhD
Sponsor: Oregon Health Sciences University

Location(s): United States


The proposed research seeks to examine the relationship between financial conflicts of Interest and recommendations in ClinicalPractice guidelines. This application outlines an approach to describe the current level of industry relationships in an important segment of Practice guidelines, specifically those on glycemic control in diabetes. We will examine the impact of industry relationships on the quality and specific recommendations in these Practice guidelines. The specific aims are to:

1) assess the quality of the comparative effectiveness systematic reviews upon which Practice guidelines for the pharmacotherapy of glycemic control indiabetes were based;

2) determine the quality and robustness of Practice guidelines;

3) describe the financial relationships with industry among Practice Guideline sponsors and authors; and

4) examine relationships between industry, Guideline authors and sponsors, and Guideline recommendations.

We will identify all relevant Practiceguidelines in the National Guidelines Clearinghouse,(tm) obtain the comparative effectiveness reviews upon which each Practice Guideline was based, and assess the quality of these reviews. The quality of each Practice Guideline will be assessed and we will independently generate recommendations using the underlying comparative effectiveness reviews for each Guideline and an explicit framework. We will then compare the recommendations in the original Practice Guideline with our recommendations to assess the robustness of each recommendation. The frequency and type of financial relationships with industry for the authors and sponsor of each Guideline will be identified, and we will examine the associations between those relationships and the quality and robustness of the Practice guidelines. We will then examine the impact of financial relationships with industry on the percentage of pro-industry recommendations. Healthcare providers and patients must trust the information that they are provided with. Conflicts of Interest can bias that information, which breaks that trust, decreases the credibility of the research or guidelines, and may ultimately lead to suboptimal patient care or even harm. Understanding the impact of industry relationships will help Guideline sponsors to develop appropriate policies for managing Conflict of Interest.