Dataset Information

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

ABSTRACT:

Background

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).

Methods

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.

Results

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.

Conclusions

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.

SUBMITTER: Napierala H

PROVIDER: S-EPMC6022410 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Publications

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

Napierala Hendrik H Schäfer Luise L Schott Gisela G Schurig Niklas N Lempert Thomas T

BMC medical ethics 20180628 1

<h4>Background</h4>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).<h4>Methods</h4>We analyzed all German guidelines at the ...[more]

PMID: 29954379

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Project description:BackgroundAuthors of clinical practice guidelines (CPGs) disclose financial conflicts of interest (FCOIs) to promote transparency ethics. Typically, they do so on standard declaration forms containing generic open-ended questions on FCOIs. Yet, the literature is scant on the format and effect of alternative disclosure forms. Does supplementing a standard form with subsequent detailed disclosure forms tailored to the context of the CPG improve the yield or accuracy of FCOIs declarations?MethodsFor an international CPG in gastroenterology on the endoscopic surveillance for colorectal neoplasia in inflammatory bowel disease, we compared the use of a standard FCOIs disclosure form with a contextual FCOIs disclosure form that detailed commercial relations related to the CPG topic. This included manufacturers of endoscopes, endoscopy equipment and accessories. Participants completed the generic form early, and the supplementary contextual form six months later. We then compared the FCOI disclosures obtained.Findings26 participants provided FCOIs disclosures using both disclosure forms. We found discrepancies regarding (1) the disclosure of FCOIs (presence/absence), and (2) the listing of financial entities. While the number of participants who disclosed a FCOI remained the same (30.8%) using the two forms, disclosures were not from the same individuals: two additional participants disclosed a FCOI, whereas two participants withdrew previous disclosures. Among those who reported a FCOI in either form, we noted inconsistencies in disclosures for 70% of the participants. This included changes in FCOIs disclosure status or modifications of "their commercial relations".DiscussionAccurate reporting of FCOIs advances the transparency and ethical integrity of CPGs. Our experience suggests that a contextual FCOIs disclosure form tailored to content of the CPG with narrow, detailed questions provides supplementary, more complete FCOIs declarations than generic forms alone. The finding raises challenges on how forms are best written and formatted, optimally timed, and more effectively processed with sensitivity to professional behaviour, so as to heighten transparency.

Project description:OBJECTIVES:To evaluate workshops delivered to citizen health advocates about financial conflicts of interest in healthcare, transparency databases which disclose industry payments in the USA and Australia and the pros and cons of advocacy groups accepting industry sponsorship. DESIGN:Thematic analysis of workshop participant recorded discussions, and pre, post and 3-month follow-up questionnaires on confidence and knowledge about financial conflicts of interest, transparency databases and the merits of advocacy organisations accepting industry sponsorship. PARTICIPANTS AND SETTING:48 citizen health advocates participated in a half-day workshop, held in four Australian cities, which ended with a 1-hour recorded discussion. Participants were recruited with assistance from leading state-based health advocacy organisations. RESULTS:The thematic analysis of the recorded discussions revealed two major themes, (i) transparency and (ii) relationships with industry; and three minor themes: a lack of awareness about conflicts of interest and transparency, issues relating to trust and next steps in terms of potential reforms. In relation to transparency, participants felt strong support for transparency, strongly favouring the mandatory, extensive and accessible US Open Payments over the self-regulatory Australian model. Participants also noted that transparency had limitations, including the utility of disclosed information. In relation to industry sponsorship of advocacy groups, some participants expressed an openness to and support for accepting sponsorship, while many expressed a caution around potential downsides. Questionnaire results showed increases in both confidence and knowledge after the workshop, though only 23 of 48 participants returned the 3-month follow-up questionnaire. CONCLUSIONS:Following a half-day workshop, citizen health advocates recruited by leading health advocacy organisations expressed strong support for tough transparency rules, and mixed feelings about advocacy groups accepting sponsorship from industry. Study limitations include a non-representative sample and a large drop-out at the 3-month post-workshop follow-up.

Dataset Information

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

Background

Methods

Results

Conclusions

Publications

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

Similar Datasets

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