leitlinienwatch.de - ESC/EACTS Guidelines for the management of valvular heart disease, engl.

Evaluation by Leitlinienwatch

18.11.18

PTs.	Criterion
2	Transparency The conflict of interest declarations can be found here: https://www.escardio.org/static_file/Escardio/Guidelines/DOI/DOI_Summary_2017_VHD.pdf The conflicts of interest are not evaluated.
0	Composition of the Guideline Working Group 14 out of 18 authors/task force members have relevant conflicts of interest: - 11 authors received direct payments from valve manufacturers. - 1 author received institutional payments from heart valve manufacturers. - 4 authors received both direct and institutional payments from valve manufacturers. Only 4 authors have no relevant conflicts of interest to declare: (https://www.escardio.org/static_file/Escardio/Guidelines/DOI/DOI_Summary_2017_VHD.pdf).
0	Independence of the Coordinators/Chairs/Lead AuthorsUnabhängigkeit der Vorsitzenden/federführenden Autoren Both lead authors declare conflicts of interest. One lead author receives direct payments from 5 heart valve manufacturers, as well as institutional funding from 6 heart valve manufacturers. The other lead author receives institutional payments from 4 valve manufacturers (p. 1 and 2: https://www.escardio.org/static_file/Escardio/Guidelines/DOI/DOI_Summary_2017_VHD.pdf).
0	Abstention from Voting As is the case with other ESC guidelines, there are no rules regarding abstention from voting. There is only a brief, very general paragraph in the introduction regarding declaring conflicts of interest (1st preamble, paragraph 4: https://academic.oup.com/eurheartj/article/38/36/2739/4095039).
0	External Review of the Guideline An external review via a publicly accessible website did not occur.
0	Bonus Points The guideline documentation does not include any further measures that could reduce the influence of conflicts of interest.

Explanations to the evaluation criteria

Overall score

Good! (11-18)

Warning! (6-10)

Needs reform! (0-5)

Comment

This is yet another set of ESC guidelines that does not appropriately tackle conflicts of interest: Nearly all of the authors have various conflicts of interest – some of which are severe – involving heart valve manufacturers. These conflicts of interest have been disclosed and published but there are no consequences (in terms of abstention from voting, for instance). Heart valve operations are costly, so naturally, heart valve manufacturers have their sights on these guidelines – especially because, for all intents and purposes, the ESC guidelines apply throughout Europe and have been adopted in Germany by the Deutsche Gesellschaft für Kardiologie (German Society of Cardiology).
In addition to transparency, the ESC needs to implement effective management of conflicts of interest here; otherwise, these guidelines will not be as independent as several national guidelines (e.g. those of the German AWMF register). The following measures should be taken under consideration: targeted recruitment of independent coordinators and authors, evaluation of conflicts of interest by an independent committee that also recommends consequences for participants with conflicts of interest, exclusion of participants with severe conflicts of interest (consulting contracts), actual and documented abstention from voting in cases of minor or moderate conflicts of interest, and public review of draft guidelines.