Data Governance for Real-World Data Management: A Proposal for a Checklist to Support Decision Making.
Value Health
; 26(4S): 32-42, 2023 04.
Article
en En
| MEDLINE
| ID: mdl-36870678
ABSTRACT
OBJECTIVES:
Real-world data (RWD) and real-world evidence (RWE) can provide extensive information on healthcare for use in health technology assessment and decision making. Nevertheless, there is a lack of consensus surrounding the appropriate data governance (DG) practices for RWD/RWE. Data sharing is also a large concern, especially considering evolving data protection regulations. Our objective is to propose recommendations for international standards of evaluating the acceptability of RWD governance practices.METHODS:
After reviewing the literature, we created a checklist targeting DG practices for RWD/RWE. We then carried out a 3-round Delphi panel, including European policy makers, health technology assessment experts, and hospital managers. The consensus for each statement was measured and the checklist adjusted accordingly.RESULTS:
The literature review identified the main topics regarding RWD/RWE DG practices data privacy and security, data management and linkage, data access management, and the generation and use of RWE. Members of the Delphi panel (21 experts/25 invited) were presented a total of 24 statements related to each of the topics. Experts demonstrated a progressive level of consensus and importance ratings in all topics and to most statements. We suggest a refined checklist in which the statements rated less important or with less consensus have been removed.CONCLUSIONS:
This study suggests how the DG of RWD/RWE could be qualitatively evaluated. We propose checklists that could be used by all RWD/RWE users to help ensure the quality and integrity of RWD/RWE governance and complement data protection law.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Evaluación de la Tecnología Biomédica
/
Lista de Verificación
Tipo de estudio:
Guideline
/
Health_technology_assessment
/
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
Value Health
Asunto de la revista:
FARMACOLOGIA
Año:
2023
Tipo del documento:
Article