Patient involvement in clinical practice guidelines is poor after 12 years of German guideline standards: A review of guideline methodologies

Background: As early as 1997, the German Guideline for Guidelines laid down patient participation in guideline development as the cornerstone of good, trustworthy medical guidelines. The German Guideline Assessment Tool (DELBI) published in 2005 requires patients or relatives to be involved in the development of medical guidelines. Ideally, this should be effected through membership in the author group. The Association of the Scientific Medical Societies in Germany (AWMF) recommends this approach for the so-called S3 guidelines (systematically developed guidelines) and S2k guidelines (consensus based guidelines). The present study addresses the question of whether and to what extent German guideline publishers adhere to these principles of patient orientation. Methods: For this purpose, a descriptive analysis of the guidelines valid at the beginning of November 2017 was carried out. All guidelines (n=520) of the AWMF member societies were assessed. We evaluated S3- and S2k guidelines only, as these are of particular importance for patient involvement due to the requirement of an interdisciplinary guideline group. Data were reported on the involvement of patients (as co-authors of medical guidelines) and on the existence of guidance documents addressing patients and the public (so-called patient information and patient guidelines). Results: Regarding the 105 (165) S3 (S2k) guidelines, we found evidence on patient involvement in guideline development in 99 (134) cases (94 % of S3 / 81 % of S2k guidelines). In 61 (87) guidelines, authors had contributed to the authors group (58 % / 53 %) and 59 (80) guidelines with voting rights (56 % / 48 %). For 50 (15) S3 (S2k) guidelines (48 % /9 %), the guideline report provided information on the existence or planned development of guidance documents for patients and the public (patient guidelines or patient information). Guidance-related patient information was available on the internet for only 37 (2) S3 (S2k) guidelines (35 % / 2 %). Conclusion: A substantial gap remains between patient /public involvement standards for guideline development and practice in Germany, even 12 years after the publication of national guideline standards. This is a missed opportunity since guidelines without adequate participation of those affected by the recommendations have a problem of legitimacy and transparency. Only guidelines where patients were involved in all voting processes during development build and strengthen trust between patients and the medical profession. And only those who present the rationale for medical recommendations in a generally understandable and comprehensible manner let affected individuals make individual decisions