Do existing real-world data sources generate suitable evidence for the HTA of medical devices in Europe? Mapping and critical appraisal.
Int J Technol Assess Health Care
; 37(1): e62, 2021 Apr 26.
Article
en En
| MEDLINE
| ID: mdl-33896433
ABSTRACT
AIM:
Technological and computational advancements offer new tools for the collection and analysis of real-world data (RWD). Considering the substantial effort and resources devoted to collecting RWD, a greater return would be achieved if real-world evidence (RWE) was effectively used to support Health Technology Assessment (HTA) and decision making on medical technologies. A useful question is To what extent are RWD suitable for generating RWE?METHODS:
We mapped existing RWD sources in Europe for three case studies hip and knee arthroplasty, transcatheter aortic valve implantation (TAVI) and mitral valve repair (TMVR), and robotic surgery procedures. We provided a comprehensive assessment of their content and appropriateness for conducting the HTA of medical devices. The identification of RWD sources was performed combining a systematic search on PubMed with gray literature scoping, covering fifteen European countries.RESULTS:
We identified seventy-one RWD sources on arthroplasties; ninety-five on TAVI and TMVR; and seventy-seven on robotic procedures. The number, content, and integrity of the sources varied dramatically across countries. Most sources included at least one health outcome (97.5%), with mortality and rehospitalization/reoperation the most common; 80% of sources included resource outcomes, with length of stay the most common, and comparators were available in almost 70% of sources.CONCLUSIONS:
RWD sources bear the potential for the HTA of medical devices. The main challenges are data accessibility, a lack of standardization of health and economic outcomes, and inadequate comparators. These findings are crucial to enabling the incorporation of RWD into decision making and represent a readily available tool for getting acquainted with existing information sources.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Evaluación de la Tecnología Biomédica
/
Almacenamiento y Recuperación de la Información
Tipo de estudio:
Health_technology_assessment
/
Prognostic_studies
País/Región como asunto:
Europa
Idioma:
En
Revista:
Int J Technol Assess Health Care
Asunto de la revista:
PESQUISA EM SERVICOS DE SAUDE
Año:
2021
Tipo del documento:
Article
País de afiliación:
Italia