Management of financial conflicts of interests in clinical practice guidelines in Germany: results from the public database GuidelineWatch

Hendrik Napierala, Luise Schäfer, Gisela Schott, Niklas Schurig, Thomas Lempert

The reliability of clinical practice guidelines has been disputed because guideline panel members are often burdened with financial conflicts of interest (COI). Current recommendations for COI regulation advise not only detailed declaration but also active management of conflicts. To continuously assess COI declaration and management in German guidelines we established the public database LeitlinienWatch (GuidelineWatch). We analyzed all German guidelines at the highest methodological level (S3) that included recommendations for pharmacological therapy (n = 67) according to five criteria: declaration and assessment of COI, composition of the guideline development group, independence of the coordinators and lead authors, imposed abstentions because of COI and public external review. Each criterion was assessed using predefined outcome categories. Most guidelines (76%) contained a detailed declaration of COI. However, none of the guidelines provided full transparency of COI assessment results. The guideline group was composed of a majority of participants with COI in 55% of the guidelines, no guideline was free of participants with COI. Only 9% of guidelines had coordinators and lead authors without any financial COI. Most guidelines (70%) did not provide a rule for abstentions for participants with COI. In 21% of guidelines there was a rule, but abstentions were either not practiced or not documented, whereas in 7% partial abstentions and in 2% complete abstentions were documented. Two thirds of the guideline drafts (67%) were not externally reviewed via a public website. COI are usually documented in detail in German guidelines of the highest methodological level. However, considerable improvement is needed regarding active management of COI, including recruitment of independent experts for guideline projects, abstention from voting for participants with COI and external review of the guideline draft. We assume that the publicly available ratings on GuidelineWatch will improve the handling of conflicts of interest in guideline development.