A strategy for patient involvement in clinical practice guidelines: methodological approaches

Background: An increasing number of initiatives involve patients in the development of Clinical Practice Guidelines (CPGs). However, the method used for patient involvement is fundamental to achieving a quality patient-oriented CPG. The objective is to present a strategy for patient involvement that includes both robust patient consultation and participation. This strategy is based on the authors' experience in the development of four CPGs included in the Spanish National CPG Development Program, which deemed it a valuable nation-wide patient involvement initiative. Methods: Patient consultation in the CPG preparation phase combines quantitative and qualitative primary research techniques as well as a systematic review of patient-perspective studies. Participation relies on patients and patient representatives as members of the guideline development groups in all development phases at the same level as professionals. NVivo 8 software was used to analyse discourses of qualitative data. Results: Patients and patient representatives provided relevant information on their perspectives, experiences with the illness, social circumstances, habits, values and preferences. They collaborated in different CPG development phases, including setting the scope and objectives, defining key research questions, writing and reviewing recommendations, developing patients' versions and the dissemination of CPGs. Conclusions: The authors' strategy allows for patient-oriented CPG development, but it requires appropriate training and knowledge of qualitative research techniques (primary research and systematic review of qualitative evidence) for developers. It is also crucial to have specific support for patients, previously selected with eligibility criteria, to facilitate an effective engagement, providing clear guidance on their roles and ensuring opportunities to attend training events.