Development and Pilot Test of the Registry Evaluation and Quality Standards Tool: An Information Technology–Based Tool to Support and Review Registries |
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| Institution: | 1. National Institute for Health and Care Excellence, Manchester, England, UK;2. R-connect, Basel, Germany;3. Robert Koch Institute, Berlin, Germany;4. Institute for Healthcare Management and Research, University of Duisburg-Essen, Duisburg, Germany;5. Area of Preventive Medicine and Public Health, University of Santiago de Compostela, A Coruña, Spain;6. Galician Agency for Health Knowledge Management (avalia-t; ACIS), Santiago de Compostela, Spain;7. Department of Neuropediatrics and Muscle Disorders, University Medical Center Freiburg, Faculty of Medicine, Freiburg, Germany;8. NeuroTransData, Neuberg, Germany;9. Vall d’Hebron Hospital Universitari, Barcelona, Spain;10. Agència de Qualitat i Avaluació Sanitàries de Catalunya Health Services Research Group, Barcelona, Spain;11. Health Services Research Group, Vall d’Hebron Institut de Recerca, Barcelona, Spain;12. DS3, Servei Català de la Salut, Barcelona, Spain;13. Haute Autorité de Santé, Saint-Denis, France;1. Section of Allergy and Immunology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA;2. Geisel School of Medicine at Dartmouth, Hanover, NH, USA;3. Section of Allergy and Immunology, Department of Pediatrics, Children’s Hospital Colorado, University of Colorado Denver School of Medicine, Aurora, CO, USA;1. Health Economics Unit, Centre for Health Policy, Melbourne School of Global and Population Health, University of Melbourne, Melbourne, Victoria, Australia;2. Murdoch Children’s Research Institute, Melbourne, Victoria, Australia;3. Centre for Health Economics, Monash Business School, Monash University, Melbourne, Victoria, Australia;4. Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia;5. Department of Allergy and Immunology, The Royal Children’s Hospital, Melbourne, Victoria, Australia;1. School of Health and Related Research, University of Sheffield, Sheffield, England, UK;2. Department of Economics, University of Sheffield, Sheffield, England, UK;1. Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA;2. Department of Medicine, Tufts University School of Medicine, Boston, MA, USA |
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| Abstract: | ObjectivesHealth 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).MethodsREQueST 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.ResultsHaute 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.ConclusionsThe 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. |
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| Keywords: | European Network for Health Technology Assessment evaluation health technology assessment registry |
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