Development and Pilot Test of the Registry Evaluation and Quality Standards Tool: An Information Technology–Based Tool to Support and Review Registries

• Published in: Value in health Vol. 25; no. 8; pp. 1390 - 1398
• Main Authors: Allen, Alexander, Patrick, Hannah, Ruof, Jorg, Buchberger, Barbara, Varela-Lema, Leonor, Kirschner, Janbernd, Braune, Stefan, Roßnagel, Fabian, Giménez, Emmanuel, Cuscó, Xavier Garcia, Guilhaume, Chantal
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2022
• Subjects: European Network for Health Technology Assessment; evaluation; health technology assessment; registry; evaluation; health technology assessment; European Network for Health Technology Assessment; registry
• ISSN: 1098-3015; 1524-4733
• DOI: 10.1016/j.jval.2021.12.018

Health technology assessment (HTA) bodies are increasingly making use of real-world evidence and data. High-quality registries could be an asset for this; nevertheless, there is a lack of specified standards to assess the quality of data in the registry, or the registry itself. The European Network for Health Technology Assessment Joint Action 3 led the work to develop a tool for the evaluation of clinical registries: the “Registry Evaluation and Quality Standards Tool” (REQueST). REQueST was developed in 4 steps: (1) A partnership between HTA bodies across Europe drafted the assessment criteria. (2) Multiple rounds of consultation across HTA bodies and the public domain developed an Excel version of REQueST. (3) This version was transformed into a web-based application. (4) An external pilot tested this REQueST tool with SMArtCARE and NeuroTransData registries. Haute Autorité de Santé, the National Institute for Health and Care Excellence, and the Croatian Institute of Public Health led the development of REQueST. Another 4 HTA bodies contributed regularly to development meetings, and all European Network for Health Technology Assessment partners were invited to contribute. Eight methodological, 12 essential, and 3 supplementary criteria were identified. Both pilot registries scored well, fulfilling the requirements for >70% of criteria, with none failed. Feedback by registry holders led to streamlining of the process and clarification of the criteria. The REQueST tool uses an iterative and collaborative methodology with registry holders. It has the potential to maximize the utility of registry data for decision making by regulatory and HTA bodies and provides a foundation for future research. •Health technology assessment bodies are increasingly making use of real-world evidence and data, with recommendation often involving the development and use of registries to assist in this.•There is a lack of specified and consistent standards to assess the quality of data in the registry, or the registry itself, across organizations.•The Registry Evaluation and Quality Standards Tool uses an iterative and collaborative methodology with the registry holders and maximizes the ability for data collected from registries to be better used by agencies and for decision making and provides a strong foundation for future research and applications.