The emerging economic evidence and methods used to evaluate clinical registries: a systematic scoping review protocol.

Introduction: A clinical registry is a systematically collected database of health-specific information about a patient population. Clinical registries can be used for a variety of purposes including surveillance, monitoring of outcomes and patient care. The establishment and maintenance of clinical registries come with a significant cost. This scoping review aims to identify the methods used to economically evaluate clinical registries including their costs and benefits.

Methods: This systematic scoping review protocol has been developed in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. The final review will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist. The electronic databases Medline, Embase, Cochrane Library and The Cumulative Index to Allied Health Literature(CINAHL) database will be searched. Relevant national organisation websites will be searched to identify empirical studies within grey literature. The inclusion criteria include studies that economically evaluate clinical registries and are published in the English language from inception to February 2025. Two reviewers will independently screen 100% of titles and abstracts and full texts of studies for inclusion. Data will be extracted from eligible studies prior to being assessed for quality using a multi-tool approach.

Ethics and dissemination: The findings of this review will be published in an international peer-reviewed journal. They are likely to be of interest to custodians of existing clinical registries and to those wishing to establish or evaluate clinical registries.KeywordsClinical registries, economic evaluation, costs, cost-effectiveness, health economics, registry based studies.