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

Evaluation by Leitlinienwatch

26.12.16

PTs.	Criterion
2	Transparency A detailed list of each author’s potential conflicts of interest is published on the ESC homepage (http://www.escardio.org/static_file/Escardio/Guidelines/DOIs_Cardiac_Pacing_2013.pdf).
0	Composition of the Guideline Working Group 17 out of 18 authors in the guideline working group declare financial conflicts of interest; 15 of them have conflicts of interest directly connected to the subject of the guidelines. This means that these 15 authors receive direct financial benefits from manufacturers of pacemakers and CRT devices. 23 out of the 26 internal reviewers for the guidelines declare conflicts of interest; 13 of them have conflicts of interest specifically relevant to the subject of the guidelines.
0	Independence of the Coordinators/Chairs/Lead AuthorsUnabhängigkeit der Vorsitzenden/federführenden Autoren The lead author declares financial conflicts of interest directly connected to the subject of the guidelines.
0	Abstention from Voting The documentation does not provide any information regarding abstention from voting or rules regarding abstention.
0	External Review of the Guideline The documentation does not indicate that an external review of the guideline was undertaken.
1	Bonus Points According to the recommendations for drawing up guidelines on the ESC homepage (http://www.escardio.org/static_file/Escardio/Guidelines/ESC%20Guidelines%20for%20Guidelines%20Update%202010.pdf, Section 4.4) a comprehensive internal review process is conducted that can also involve experts from outside the ESC as needed.

Explanations to the evaluation criteria

Comment

European Society of Cardiology (ESC) guidelines outside the German AWMF guideline register. (http://eurheartj.oxfordjournals.org/content/ehj/34/29/2281.full.pdf). The ESC guidelines also apply in Germany as the Deutsche Gesellschaft für Kardiologie (German Society of Cardiology) publishes a pocket guideline entitled “Schrittmacher- und kardiale Resynchronisationstherapie” (“Cardiac Pacing and Cardiac Resynchronization Therapy”) that is based on the ESC guidelines.
It appears problematic that nearly all of the guideline authors, including the lead author, have relevant financial conflicts of interest. A specific guideline report is not available. The ESC only published general recommendations for drawing up guidelines (http://www.escardio.org/static_file/Escardio/Guidelines/ESC%20Guidelines%20for%20Guidelines%20Update%202010.pdf). Study evaluation methods are not apparent in these recommendations; conflicts of interest are transparently disclosed, but any consequences derived from these disclosures – such as rules regarding abstention from voting – are not indicated.
The regulation of ESC guideline authors’ conflicts of interest requires comprehensive reform; the current recommendations from the Guideline International Network and from the AWMF could serve as a model here. Important aspects of a reform would include the recruitment of independent authors, transparent evaluation of conflicts of interest in terms of their relevance to the guideline in question and a consistent rule regarding abstention from voting in cases where conflicts of interest remain.