RT Journal Article
T1 The use of nonrandomized evidence to estimate treatment effects in health technology assessment.
A1 Kent, Seamus
A1 Salcher-Konrad, Maximilian
A1 Boccia, Stefania
A1 Bouvy, Jacoline C
A1 Waure, Chiara de
A1 Espin, Jaime
A1 Facey, Karen
A1 Nguyen, Mary
A1 Rejon-Parrilla, Juan Carlos
A1 Jonsson, Pall
K1 comparative effectiveness research
K1 health technology assessment
K1 nonrandomized trials
K1 observational research
K1 real-world evidence
AB Health technology assessment (HTA) is increasingly informed by nonrandomized studies, but there is limited guidance from HTA bodies on expectations around evidence quality and study conduct. We developed recommendations to support the appropriate use of such evidence based on a pragmatic literature review and a workshop involving 16 experts from eight countries as part of the EU's Horizon-2020 IMPACT-HTA program (work package six). To ensure HTA processes remain rigorous and robust, HTA bodies should demand clear, extensive and structured reporting of nonrandomized studies, including an in-depth assessment of the risk of bias. In recognition of the additional uncertainty imparted by nonrandomized designs in estimates of treatment effects, HTA bodies should strengthen early scientific advice and engage in collaborative efforts to improve use of real-world data.
YR 2021
FD 2021-07-19
LK http://hdl.handle.net/10668/18220
UL http://hdl.handle.net/10668/18220
LA en
DS RISalud
RD Apr 5, 2025