Patient involvement in the development of clinical practice guidelines in Germany—A meta-research study

Introduction

Patient involvement (PI) is a key element of clinical practice guidelines (CPGs). However, PI in CPGs often falls short of quality standards. For evidence- and consensus-based CPGs in Germany, a study in 2018 showed that a mere 58% had included a patient (participation), 56% with voting right. We aimed to provide an update on whether and how patients were involved in CPGs (participation and consultation), on the availability of patient versions (PVGs) (communication) and to investigate whether CPGs in Germany adhere to the RIGHT checklist.

Methods

An electronic search on the Register of the Association of Scientific Medical Societies was performed. Eligibility criteria were defined a priori. We included evidence- and consensus-based CPGs valid on 31 March 2023. A data extraction form including 35 items was designed and piloted. Five researchers independently extracted data from CPGs, methodology reports and PVGs. Data were analysed descriptively.

Results

The search identified 135 CPGs meeting the eligibility criteria. Participation has increased to 79% (107/135 CPGs), in 73% of CPGs (98/135) with voting right. Participation was more common in CPGs for chronic than acute conditions (76/86 CPGs, 88% chronic vs. 23/38 CPGs, 61% acute). Consultation was scarcely employed (3/135 CPGs, 2%). Communication, operationalised as PVGs being available on the internet, increased from 33% (35/105) in 2018 to 43% (58/135) in 2023. 26% of CPGs (28/107) with participation reported on patients' selection as required by the RIGHT checklist.

Discussion

PI has improved, although around 20% of CPGs were still developed without participation. This applies in particular to CPGs on acute conditions where PI should be strengthened. At the same time, innovative and efficient methods for consultation and for evaluating patients' impact are required. Moreover, communication should be expanded. To further improve transparency in CPGs, guideline development groups should specifically report on patients' recruitment and selection.