Piloting a PREMs and PROMs longitudinal survey on the integration of healthcare services for patients living with hepatitis C in Tuscany region: study protocol

Introduction: Patient-reported measures are an invaluable resource for health systems to improve the quality of healthcare services. Patients with hepatitis C virus (HCV) are an under-represented group within the stream of literature on collecting and using the experiences and outcomes reported by patients to improve healthcare performance. This protocol outlines the methodology to implement a longitudinal survey in Tuscany, Italy, to systematically gather patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) for patients with HCV, with a focus on the integration of primary and hospital care. Methods and analysis: We designed and developed a longitudinal survey to collect HCV PREMs and PROMs. The survey, which lasts 1 year, consists of three questionnaires, starting with the first visit with a specialist/treatment initiation, with follow-ups at 6 and 12 months. It was implemented in six hospitals in Tuscany, Italy, of which three are University Hospitals. The survey was offered to all patients treated for HCV at these healthcare centres, deliberately not applying a specific criterion for patient selection, through both paper based and electronic modes of completion. The data from the three structured questionnaires will be analysed quantitatively. Ethics and dissemination: The Ethics Committee for Clinical Experimentation of Area Vasta Nord Ovest approved the protocol (CEAVNO-CODE 18829). Participation in this study is voluntary. Study results will be disseminated through peer-reviewed publications and academic conferences.