Leitlinienwatch

Evaluation by Leitlinienwatch

11.02.25

PTs.	Criterion
2	Transparency The ESC's handling of conflicts of interest is defined in the "ESC Declaration and Management of Conflict of Interest Policy", last updated in April 2023 (https://www.escardio.org/static-file/Escardio/Web/Documents/ESC-Declaration-and-Management-of-COI-Policy.pdf). For this guideline published in 2021, the 2020 version was used. The authors report on their conflicts of interest for 2019 and 2020, while the reviewers and representatives of the national professional societies report in the appendix to the guideline (2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy) about their conflicts of interest only for the year 2020. The "ESC Declaration and Management of Conflict of Interest Policy" (https://www.escardio.org/The-ESC/About/Policies/esc-declaration-and-management-of-conflict-of-interest-policy#process) names various committees in the ESC, such as the "Office of Compliance" and the "Senior Compliance Council", which are supposed to regulate conflicts of interest in the development of ESC guidelines. How this happens, who is active in these committees, what they decide on what basis is not clear. There was therefore no comprehensible assessment of the reported conflicts of interest by coordinators or an external committee.
0	Composition of the Guideline Working Group 21 of 24 (88%) authors of the guideline committee reported an average of 5.8 (1-17) conflicts of interest (COI).
0	Independence of the Coordinators/Chairs/Lead AuthorsUnabhängigkeit der Vorsitzenden/federführenden Autoren Both lead authors indicate COIs with 1 or 5 pharmaceutical and medical device companies, respectively. One of the two coordinators has COIs with 1 pharmaceutical and 1 medical device company each.
0	Abstention from Voting All authors participated in the voting, regardless of any conflicts of interest. The recommendations required the approval of at least 75% of the authors.
0	External Review of the Guideline No external consultation took place.
1	Bonus Points Bonus point for internal review process by reviewers who submitted an COI declaration for 2020. However, 74% of reviewers report up to an average of 3.7 (1-14) conflicts of interest.

Explanations to the evaluation criteria

Overall score

Good! (11-18)

Warning! (6-10)

Needs reform! (0-5)

Comment

This guideline published by the ESC in 2021 (European Heart Journal; 2021 - doi/10.1093/eurheartj/ehab364) was adopted unchanged by the German Society of Cardiology (DGK) in 2022 and published as a pocket guideline as all guidelines before. In this ESC guideline, too, the majority of authors (88%) report relevant conflicts of interest. In this context, relevant means that the majority of all authors have financial relationships with one or more manufacturers of the very medical devices on which they are supposed to make independent judgments. A significant weakness here (as with all other ESC guidelines) is the fact that all authors were allowed to vote on the recommendations regardless of the existence of their conflicts of interest.
The ESC's now planned first steps to regulate conflicts of interest of future guideline authors are to be welcomed. However, the exclusion of authors with more than 10,000€ in industry payments per year leaves an inappropriate scope for cumulative payments from a company to individual authors over several years. In addition, there is no clear rule for abstentions when voting on recommendations, only a general expectation that participants with COI should abstain (Principle 3, p.2, https://www.escardio.org/static-file/Escardio/Web/Documents/ESC-Declaration-and-Management-of-COI-Policy.pdf).

2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy, engl.

Evaluation by Leitlinienwatch

Comment