Pisavadia Kalpa, Hartfiel Ned, Varghese Limssy, Krayer Anne, Hobson Gemma, Masters Rebecca, Poole Rob, Robinson Catherine, Edwards Rhiannon Tudor, Bebbington Emily
Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK
Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.
BMJ Open. 2025 Jun 24;15(6):e100644. doi: 10.1136/bmjopen-2025-100644.
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.
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.
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.Clinical registries, economic evaluation, costs, cost-effectiveness, health economics, registry based studies.
临床注册库是一个系统收集的关于患者群体特定健康信息的数据库。临床注册库可用于多种目的，包括监测、结果监测和患者护理。临床注册库的建立和维护成本高昂。本范围综述旨在确定用于对临床注册库进行经济评估的方法，包括其成本和效益。
本系统范围综述方案是根据系统评价与Meta分析方案的首选报告项目（PRISMA-P）指南制定的。最终综述将按照系统评价与Meta分析扩展版范围综述的首选报告项目（PRISMA-ScR）清单进行报告。将检索电子数据库Medline、Embase、Cochrane图书馆和联合健康文献累积索引（CINAHL）数据库。将搜索相关国家组织网站，以识别灰色文献中的实证研究。纳入标准包括从开始到2025年2月以英文发表的对临床注册库进行经济评估的研究。两名评审员将独立筛选100%的研究标题、摘要和全文以确定是否纳入。在使用多工具方法评估质量之前，将从符合条件的研究中提取数据。
本综述的结果将发表在国际同行评审期刊上。现有临床注册库的管理者以及希望建立或评估临床注册库的人可能会对其感兴趣。临床注册库、经济评估、成本、成本效益、卫生经济学、基于注册库的研究。
