Real-world data and patient-reported outcomes in diabetes in Emilia-Romagna (REWINDER): protocol of a federated cohort study for the regional evaluation of quality of care during and after COVID-19.

Abstract

Introduction: Real-world data and patient-reported outcomes in diabetes in Emilia-Romagna is a multi-centric observational cohort study aimed at improving diabetes care in the Emilia-Romagna region, by exploring trends and predictors of clinical and psychological parameters in a large population of people with diabetes, during and after the COVID-19 pandemic.

Methods and analysis: The study has a mixed retrospective/prospective design. The retrospective component involves computerised data linkage of administrative and clinical data from the local health authorities of Romagna and Reggio Emilia, and the University Hospital of Parma, covering a population of approximately 100 000 prevalent cases with diabetes, followed throughout the years 2019-2024. The selection of data items collected in the reference time frame is based on the International Consortium for Health Outcomes Measurement (ICHOM) standard set for diabetes, including clinical, lifestyle, social and healthcare service measurements. The prospective component includes primary data collection of indicators of psychological well-being through the WHO-5 Well-Being Index, diabetes distress using the Problem Areas In Diabetes-Short Form and depression through the Patient Health Questionnaire-9, measured at 0-6 months in an overall sample of 455 people with type 2 diabetes. Statistical analysis will include descriptive analysis and multivariate logistic regression using a two-step federated approach.

Ethics and dissemination: The study has obtained ethics approval from the Ethics Committee of Romagna and the Ethics Committee of Area Vasta Emilia Nord. The results of the study will be published in scientific journals to evaluate quality and outcomes of diabetes care across the region.

Trial registration number: NCT06639100.