Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making.
Pharmacoepidemiol Drug Saf
; 26(9): 1033-1039, 2017 Sep.
Article
en En
| MEDLINE
| ID: mdl-28913966
ABSTRACT
PURPOSE:
Real-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making.METHODS:
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies. Peer review by ISPOR/ISPE members and task force participants provided a consensus-building iterative process for the topics and framing of recommendations.RESULTS:
The ISPOR/ISPE Task Force recommendations cover seven topics such as study registration, replicability, and stakeholder involvement in RWE studies. These recommendations, in concert with earlier recommendations about study methodology, provide a trustworthy foundation for the expanded use of RWE in health care decision making.CONCLUSION:
The focus of these recommendations is good procedural practices for studies that test a specific hypothesis in a specific population. We recognize that some of the recommendations in this report may not be widely adopted without appropriate incentives from decision makers, journal editors, and other key stakeholders.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Farmacoepidemiología
/
Economía Farmacéutica
/
Comités Consultivos
/
Toma de Decisiones
/
Atención a la Salud
/
Ensayos Clínicos Pragmáticos como Asunto
Tipo de estudio:
Evaluation_studies
/
Guideline
/
Health_economic_evaluation
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Humans
Idioma:
En
Revista:
Pharmacoepidemiol Drug Saf
Asunto de la revista:
EPIDEMIOLOGIA
/
TERAPIA POR MEDICAMENTOS
Año:
2017
Tipo del documento:
Article
País de afiliación:
Estados Unidos