Declaration and Handling of Conflicts of Interest in Guidelines

Schott, Gisela; Lieb, Klaus; König, J.; Mühlbauer, Bernd; Niebling, Wilhelm; Pachl, Henry; Schmutz, Stephan; Ludwig, Wolf‐Dieter

doi:10.3238/arztebl.2015.0445

Cited by 8 publications

(7 citation statements)

References 25 publications

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“…Twelve articles provided evidence on the effects of a conflict of interest management strategy in the context of clinical practice guideline development 17–28 (see Suppl. Table S2).…”

Section: Resultsmentioning

confidence: 99%

“…Eight articles described studies that used document analysis and/or analysis of linked data sets to assess compliance with the strategy of conflict of interest disclosure to advisees. 17,18,[21][22][23][24][25][26] When researchers made no attempt to verify the accuracy of disclosures, 93% to 100% of guidelines and 84% to 98% of guideline authors were determined to be in compliance with disclosure requirements. 17,18,[21][22][23][24] However, when researchers used public industry payment data to verify the accuracy of disclosures, up to 23% of guideline authors were found to have omitted 1 or more financial relationships from their disclosures.…”

Section: What Are the Effects Of Different Strategies For Managing Co...mentioning

confidence: 99%

“…17,18,[21][22][23][24][25][26] When researchers made no attempt to verify the accuracy of disclosures, 93% to 100% of guidelines and 84% to 98% of guideline authors were determined to be in compliance with disclosure requirements. 17,18,[21][22][23][24] However, when researchers used public industry payment data to verify the accuracy of disclosures, up to 23% of guideline authors were found to have omitted 1 or more financial relationships from their disclosures. 18,25,26 Two articles described document analysis studies that assessed compliance with the strategy of preselection disclosure of potential conflicts of interest to guideline development group conveners, 21,27 2 articles described document analysis studies that assessed compliance with the strategy of advance discussion of member conflicts of interest by the prospective guideline development group, 21,27 and 1 article described a document analysis study that assessed compliance with the strategy of explaining to guideline development group members how identified conflicts of interest could influence group decisions.…”

Section: What Are the Effects Of Different Strategies For Managing Co...mentioning

confidence: 99%

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Addressing Conflicts of Interest in Health and Medicine: Current Evidence and Implications for Patient Decision Aid Development

et al. 2021

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Background More stringent policies for addressing conflicts of interest have been implemented around the world in recent years. Considering the value of revisiting conflict of interest quality standards set by the International Patient Decision Aid Standards (IPDAS) Collaboration, we sought to review evidence relevant to 2 questions: 1) What are the effects of different strategies for managing conflicts of interest? and 2) What are patients’ perspectives on conflicts of interest? Methods We conducted a narrative review of English-language articles and abstracts from 2010 to 2019 that reported relevant quantitative or qualitative research. Results Of 1743 articles and 118 abstracts identified, 41 articles and 2 abstracts were included. Most evidence on the effects of conflict of interest management strategies pertained only to subsequent compliance with the management strategy. This evidence highlighted substantial noncompliance with prevailing requirements. Evidence on patient perspectives on conflicts of interest offered several insights, including the existence of diverse views on the acceptability of conflicts of interest, the salience of conflict of interest type and monetary value to patients, and the possibility that conflict of interest disclosure could have unintended effects. We identified no published research on the effects of IPDAS Collaboration conflict of interest quality standards on patient decision making or outcomes. Limitations Because we did not conduct a systematic review, we may have missed some evidence relevant to our review questions. In addition, our team did not include patient partners. Conclusions The findings of this review have implications for the management of conflicts of interest not only in patient decision aid development but also in clinical practice guideline development, health and medical research reporting, and health care delivery.

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“…Twelve articles provided evidence on the effects of a conflict of interest management strategy in the context of clinical practice guideline development 17–28 (see Suppl. Table S2).…”

Section: Resultsmentioning

confidence: 99%

Section: What Are the Effects Of Different Strategies For Managing Co...mentioning

confidence: 99%

Section: What Are the Effects Of Different Strategies For Managing Co...mentioning

confidence: 99%

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Addressing Conflicts of Interest in Health and Medicine: Current Evidence and Implications for Patient Decision Aid Development

et al. 2021

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“…Previous studies mostly focused on prevalence and declaration of COI. High rates of guideline authors with COI seem to be a universal finding [ 11 – 14 ] while open declaration of COI varies between countries from 2% of guidelines in Denmark [ 22 ] to 93% in Germany [ 16 ].…”

Section: Discussionmentioning

confidence: 99%

“…However, analysis of published guidelines reveals that COI are pervasive and rarely actively managed [ 11 – 14 ]. Two studies from Germany showed adequate declaration of COI in most guidelines but a lack of appropriate measures to minimize their influence on guideline content [ 15 , 16 ].…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2018

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BackgroundThe 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).MethodsWe 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.ResultsMost 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.ConclusionsCOI 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.Electronic supplementary materialThe online version of this article (10.1186/s12910-018-0309-y) contains supplementary material, which is available to authorized users.

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Financial Conflicts of Interest in Clinical Practice Guidelines: A Systematic Review

Tabatabavakili

Khan

Scaffidi

et al. 2021

Mayo Clinic Proceedings: Innovations, Quality & Outcomes

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Objective: To systematically evaluate the prevalence of disclosed and undisclosed financial conflicts of interest (FCOI) among clinical practice guidelines (CPGs). Methods: In this systematic review, we ascertained the prevalence and types of FCOI for CPGs from January 1, 1980, to March 3, 2019. The primary outcome was the prevalence of FCOI among authors of CPGs. FCOI disclosures were compared between medical subspecialties and societies producing CPGs. Results: Among the 37 studies including 14,764 total guideline authors, 45% had at least one FCOI. The prevalence of FCOI per study ranged from 6% to 100%. More authors had FCOI involving general payments (39%) compared with research payments (29%). Oncology, neurology, and gastroenterology had the highest prevalence of FCOI compared with other medical specialties. Among the 8 studies that included the monetary values in US dollars of FCOI, average payments per author ranged from $578 to $242,300. Among the 10 studies that included data on undisclosed FCOI, 32% of authors had undisclosed industry payments. Conclusion: There are numerous FCOI among authors of CPGs, many of which are undisclosed. Our study found a significant difference in FCOI prevalence based on types of FCOI and CPG sponsor society. Additional research is required to quantify the implications of FCOI on clinical judgment and patient care.

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Declaration and Handling of Conflicts of Interest in Guidelines

Abstract: Conflicts of interest are often declared in the S1 guidelines of the AWMF, but they are only rarely assessed by external evaluators. Clear rules should be issued for how experts' declared conflicts of interest should be acted upon, whether they are of a financial nature or not.

Cited by 8 publications

References 25 publications

Addressing Conflicts of Interest in Health and Medicine: Current Evidence and Implications for Patient Decision Aid Development

Addressing Conflicts of Interest in Health and Medicine: Current Evidence and Implications for Patient Decision Aid Development

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

Financial Conflicts of Interest in Clinical Practice Guidelines: A Systematic Review

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