Leitlinienwatch

Sexual and Reproductive Health

Year of publication: 2023

Editing medical society(ies):
European Association of Urology (EAU)

Other medical societies involved: 0

Evaluation by Leitlinienwatch

25.03.24

PTs.	Criterion
0	Transparency This is a European guideline outside the German AWMF register (https://uroweb.org/guidelines/sexual-and-reproductive-health). In the 312-page guideline document, the section on conflicts of interest (p. 311) takes up seven lines and refers to a website which contains no information on the topic. The same is true for a sentence in the introduction. Only in the online version of the guideline some conflicts of interest are listed for four of the 20 guideline authors (located in the "Panel" section), two of which read "other - please indicate". For the remaining 16, including the two guideline committee chairs, there is no information on conflicts of interest.
0	Composition of the Guideline Working Group The proportion of guideline authors with conflicts of interest cannot be assessed as detailed conflict of interest declarations are not available. For most authors it remains unclear whether a declaration of conflicts of interest was made at all and what its content was.
0	Independence of the Coordinators/Chairs/Lead AuthorsUnabhängigkeit der Vorsitzenden/federführenden Autoren The guideline committee chairs also have not declared any conflicts of interest. One of the chairs recently published an opinion piece which describes the benefits of financial support from the pharmaceutical industry: "In fact, the financial support of pharma has been paramount to the execution of research studies and the public presentation of results in the contexts of dedicated experts. [...] All of this has been thanks to the sponsorship of pharma, who have been able to promote their belief and support in the development of a healthy and correct scientific culture while supporting their own business objectives." (Salonia A, Capogrosso P. Publishing industry-sponsored studies. The Journal of Sexual Medicine. 2023;20(4):422-425. doi:10.1093/jsxmed/qdad003).
0	Abstention from Voting The "EAU Guidelines Conflict of Interest Policy" available on the website of the European Association of Urology describes an abstention rule for high-risk COI. This policy, which is not part of the guideline, is not referred to anywhere in the guideline document. It remains unclear whether it was applied. The only two specifically declared conflicts of interest should be categorised as "high-risk COI" according to the above-mentioned policy (here: stock shareholding, consultancy work). It is not clear whether these had any consequences, although information on conflict of interest management should be published according to the policy: "This information is to be made available annually online upon publication of the final Guidelines documents (as part of the supporting documents)." (p. 5, section 6)
0	External Review of the Guideline According to the information in the methods section of the guideline (p. 13, section 2.2), the original guideline was "peer reviewed" before publication and revisions in subsequent years including the current one were "reviewed". The general "EAU Guidelines Office Development Handbook" describes a review by invited "international expert reviewers" and a patient representative "where applicable". It is not clear how the review was carried out in this specific guideline and to what extent the outcome of the review influenced the final version of the guideline. A public review does not appear to have been planned or carried out.
1	Bonus Points The guideline methodology is only briefly described (p. 12/13). We award one bonus point for the evidence assessment by standards similar to GRADE. The European Association of Urology provides recommendations for those involved in guideline development in several methodology handbooks. These include topics such as conflicts of interest and their management as well as the involvement of patient representatives. Unfortunately, it is not clear whether and to what extent these were applied in the actual guideline development process.

Explanations to the evaluation criteria

Overall score

Good! (11-18)

Warning! (6-10)

Needs reform! (0-5)

Comment

The EAU's comprehensive guideline on "Sexual and Reproductive Health" will find its readers in Germany as well. There is no comparable German/AWMF (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften - "Working Group of Scientific Medical Associations") guideline available. Unfortunately, the broad scope of the guideline and the apparent degree of professionalization of the European Association of Urology are not reflected in the handling of conflicts of interest. There is almost no documentation of COI for this specific guideline.

The EAU's general recommendations (Guidelines Conflict of Interest Policy, https://uroweb.org/eau-guidelines/methodology-policies) begin ambitiously: "[...] the EAU GO [Guidelines Office] aim to establish Guidelines Panels involving members that ideally have no or only very limited COI".
Unfortunately, this goal is immediately relativised:
- "it is recognised that as opinion leaders in their fields, Panel members will likely have conflicts"
- "once clinicians are involved in Guidelines development they may be more likely sought out for speaking engagements and positions on advisory boards"
- "the GO recognises that COIs are ubiquitous"

The EAU's Conflict of Interest Policy tries to substantiate these statements with a misleading quote from a 1994 editorial by former BMJ editor Richard Smith: "The only person who does not have some vested interest in a subject is somebody who knows nothing about it." (p. 1 "EAU Guidelines Conflict of Interest Policy", quoted from: Smith R. Conflict of interest and the BMJ. BMJ. 1994;308(6920):4-5. doi:10.1136/bmj.308.6920.4). In the publication, Smith actually argues in favour of stricter disclosure and avoidance of conflicts of interest.

Industry-funded lecturing and consultancy work is not an inevitable fate and best practice guidelines for dealing with conflicts of interest have long recommended that guideline authors sever existing financial ties with the pharmaceutical industry (Institute of Medicine: "Clinical practice guidelines we can trust" (2012)).

A first step towards improving the handling of conflicts of interest in this guideline could be the consistent and documented application of the EAU's own "Conflict of Interest Policy". In the medium to long term, it is advisable to motivate guideline authors to give up existing financial connections to the pharmaceutical industry and to promote authors without such connections.

The above-mentioned BMJ editorial on conflicts of interest concludes with an assessment by the editors of the New England Journal of Medicine: "most academic institutions and journals have not gone far enough in dealing with this problem" - an assessment that with regard to the EAU guideline "Sexual and Reproductive Health" ist still valid even 30 years after publication of the editorial.