Background: The importance of stakeholder involvement, including patients, in the development of clinical practice guidelines is internationally recognised. Patients’ unique experience of living with the condition and its consequences gives them a lived perspective, which could contribute to improvements in the quality and relevance of guidelines. However, there is a lack of methodology and evaluation around patient involvement in guideline development. The European Association of Urology (EAU) Guidelines Office have international reach, robust guideline development processes, an established patient information section and existing links to global cancer patient organisations, making the EAU and genitourinary cancers an ideal proving ground to test an integrated framework of patient involvement in guideline development.

Objectives: This study aims to develop a framework of meaningful patient involvement to address: which stakeholders to involve, how to involve them, at what stage of the process, and to propose a stakeholder involvement evaluation tool.

Methods: First, we systematically reviewed existing models of patient involvement in guideline development. Next, semi-structured interviews were conducted with patient and clinician members of European genitourinary cancer Guideline Panels, to assess barriers and facilitators for patient involvement. Then, a list of topic areas for considering patient involvement were scored for importance by patients and clinicians via an international Delphi survey preceding a face-to-face consensus meeting. Finally, a framework of patient involvement in guideline development and implementation was designed based on evidence from the systematic review, interviews with key stakeholders and the Delphi and consensus process.

Results: Sixteen priority areas and technical processes for patient involvement were identified via our Delphi survey and consensus meeting and these were embedded within the EVOLVE framework. The final EVOLVE framework includes recommendations for both social and technical guideline processes. These recommendations include increasing patient understanding of the processes for guideline development through focused recruitment and provision of adequate training and support; establishing a patient advisory board; and providing access to patient networks and mechanisms for feeding in the preferences and values of wider patient groups. This framework will be tested for genitourinary cancers in Europe within the 2020-2021 guideline development cycle. Normalisation Process Theory will be used to evaluate the implementation and integration of the framework and inform an evaluation tool.

Conclusions: The final EVOLVE framework provides guideline developers with clear methodology, including both social and technical processes, for patient involvement in guideline development and implementation. The next step is to test the EVOLVE framework within genitourinary cancers in Europe for the 2020-2021 guideline development cycle.

Patient or healthcare consumer involvement: Patient-led study