Patient Involvement in the Development of Clinical Practice Guidelines - An Interview Study on the Experiences of Patients and Their Representatives in Germany.

BACKGROUND

Patient involvement (PI) in the development of clinical practice guidelines (CPGs) is recognized as a key aspect of trustworthy and high-quality CPGs. However, difficulties exist and PI is not yet consistently implemented in the development of CPGs. Our study aimed at exploring the experiences and perspectives of patients and their representatives regarding their involvement in CPG development processes and to unravel existing challenges.

METHODS

Qualitative semi-structured interviews were conducted with patient representatives who already participated in the development of a German evidence- and consensus-based CPG. The interviews were conducted using a semi-structured interview guide developed a priori. They took place via the online meeting tool WebEx and were digitally recorded. The interview data was analyzed using qualitative content analysis as described by Mayring using MAXQDA.

RESULTS

In total, we conducted 23 interviews from November 2024 to February 2025. Participation in CPG development processes as active and contributing member of the guideline development group was emphasized as the dominating involvement strategy. For a positive PI experience, participants emphasized several influencing factors such as preparatory training, participation of other patient representatives, and appreciation from other guideline group members. Moreover, several challenges were anticipated for the future, for instance the recruitment of patients as well as the need for a more inclusive and diverse involvement.

DISCUSSION: Our study found that overall participants were satisfied with the predominant involvement method of acting as participatory members in the guideline development group. Nevertheless, the findings also revealed certain unmet needs. Preparatory activities, such as targeted training sessions or meetings, were identified as essential and should become standard practice. To ensure equitable implementation, CPG developers should consider taking responsibility for preparing patient representatives to participate effectively, rather than relying on patient organizations for this.