QUALITY CRITERIA FOR THE DEVELOPMENT OF IMPLANT REGISTRIES
Author(s)
Niederländer CS*;Wahlster P;Kriza C;Schaller SU, Kolominsky-Rabas PL Centre for Health Technology Assessment (HTA) and Public Health (IZPH), University of Erlangen-Nuremberg, Erlangen, Germany
OBJECTIVES: During the last few years, there has been a steady increase in the number of implant registries, mainly in the field of arthroplasty. The benefit of a registry depends on its content and quality. However, there are no further data requirements, legal and financial issues or requirements for the organizational procedure specified for implant registries in general. Therefore, the aim of this work is to identify quality criteria for the design and development of implant registries and to develop a minimal data set. METHODS: The systematic literature search was performed in different databases (Pubmed, Medline, the Cochrane Library, Scopus, Embase as well as the CRD York database) and different journals. RESULTS: Ten articles were identified that describe a general implant registry design and structure as well as 45 articles about the creation of specific registries. Most recommendations for the organization of implant registries could be found in the field of arthroplasty. To generalize the results, it can be said, that all registries have to deliver a minimal data set including prostheses, patient and surgical procedure details. The geographical area, length and periodicity of data collection, number of patients enrolled, the composition of the team as well as information about security and confidentiality of data should be reported. CONCLUSIONS: Well-structured registries are a cornerstone of the regulatory process of medical devices and a major tool for decision-makers and managers. However, only a small number of papers that describe specific requirements for the construction of an implant registry could be identified. With the establishment of clear guidelines, the outcomes of the implant registries can be fundamentally improved. This project is supported by the German Federal Ministry of Education and Research (BMBF) as part of the National Cluster of Excellence ‚Medical Technologies - Medical Valley EMN’ (Project grant No. 13EX1013B).
Conference/Value in Health Info
2013-11, ISPOR Europe 2013, The Convention Centre Dublin
Value in Health, Vol. 16, No. 7 (November 2013)
Code
MD4
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes
Disease
Multiple Diseases