Abstract
BACKGROUND: Patient and family advisory councils (PFACs) are increasingly recognised as a promising approach for improving patient safety (PS) through patient engagement (PE) at the organisational level. However, PFAC stakeholders often lack the necessary knowledge and competence to engage effectively in PS-related issues with healthcare organisations. Moreover, evidence on specific needs for knowledge and competence improvement remains limited, hindering the development of future interventions. OBJECTIVE: This study aimed (a) to identify needs for PS-related competency and knowledge improvement among PFAC stakeholders and (b) to assess current and desired levels of PFAC engagement, roles and factors influencing PFACs' work. DESIGN: We established an exploratory mixed-methods design with a modified, two-round Delphi approach. We first used qualitative content analysis to analyse interview data (Round 1) and then consolidated statements for a quantitative questionnaire (Round 2). Responses were analysed descriptively and for consensus (criterion: 85% agreement). Mixed-methods analysis was conducted sequentially and convergently. SETTING AND PARTICIPANTS: PFAC stakeholders are affiliated with German healthcare organisations, including patient representatives and professionals from healthcare organisations. MAIN VARIABLE AND OUTCOME STUDIED: (a) Needs for competency improvement on PS and communication, self-assessed knowledge and preferred training formats and (b) PFAC engagement levels, roles and factors influencing PFACs' work. RESULTS: Across 6 different oncology-focused PFACs from German university hospitals, 19 stakeholders participated across both rounds. Seventeen needs for competency improvement in PS and communication were identified. After establishing consensus, 10 distinct domains of need were agreed upon (e.g., PS fundamentals, legal basis for PE and respectful communication). While PFAC engagement in PS was inconsistent, participants expressed a strong desire for further involvement. Key implementation factors included limited access to organisational processes, lack of resources and unequal conditions between research- and care-oriented councils. DISCUSSION AND CONCLUSION: This study highlights the need for targeted training and structural support to strengthen PFACs' role in PS. Competency improvement and role clarity were deemed essential for effective collaboration. Enhancing PFAC engagement in PS requires tailored educational programmes, transparent structures and institutional support. This study provides an empirical basis for interventions to improve PE in PS at the organisational level. PATIENT OR PUBLIC CONTRIBUTION: A patient representative was actively involved throughout the research process, contributing to the development of study materials and providing independent feedback on interview guides and questionnaires. Her input helped to shape the materials, improve their accessibility to lay audiences and ensure the inclusion of patient-relevant issues. The research team discussed her feedback in detail and revised study materials accordingly. Beyond the content presented in this manuscript, she contributed to shaping a subsequent intervention that emerged from the study's needs assessment, which was designed as a participatory approach to incorporate patient and stakeholder perspectives from the outset. In addition, she and participating stakeholders of the patient advisory councils are committed to disseminating project findings and developing recommendations to help translate research into practice from a patient perspective. CLINICAL TRIAL REGISTRATION: The study was pre-registered in the German Clinical Trials Register (ID: DRKS00034733).