Irina Cleemput1, Mattias Neyt2. 1. Belgian Health Care Knowledge Centre,AC Kruidtuinirina.cleemput@kce.fgov.be. 2. Belgian Health Care Knowledge Centre,AC Kruidtuin.
Abstract
BACKGROUND: Health-related quality of life (HRQoL) is an important endpoint of many healthcare interventions. This study develops guidance on how to select appropriate HRQoL measures for inclusion in a clinical trial, given the purposes of the HRQoL measurement. METHODS: The guidance is based on a systematic literature review, discussions with members of the European Network for Health Technology Assessment (EUnetHTA) and two rounds of public consultation. RESULTS: A set of twelve recommendations was developed, addressing the requirements for HRQoL data for relative effectiveness assessment, for cost-utility analyses and for informing clinical decision making. Recommendations relate to the choice of the type of measure as well as to aspects such as measurement frequency, target population and presentation. CONCLUSIONS: The purpose and context of HRQoL measurement is crucial for the relevance of the data obtained with a specific HRQoL measure. It is recommended to always include a generic HRQoL instrument in clinical trials to cover a wide range of possible future uses of the HRQoL data.
BACKGROUND: Health-related quality of life (HRQoL) is an important endpoint of many healthcare interventions. This study develops guidance on how to select appropriate HRQoL measures for inclusion in a clinical trial, given the purposes of the HRQoL measurement. METHODS: The guidance is based on a systematic literature review, discussions with members of the European Network for Health Technology Assessment (EUnetHTA) and two rounds of public consultation. RESULTS: A set of twelve recommendations was developed, addressing the requirements for HRQoL data for relative effectiveness assessment, for cost-utility analyses and for informing clinical decision making. Recommendations relate to the choice of the type of measure as well as to aspects such as measurement frequency, target population and presentation. CONCLUSIONS: The purpose and context of HRQoL measurement is crucial for the relevance of the data obtained with a specific HRQoL measure. It is recommended to always include a generic HRQoL instrument in clinical trials to cover a wide range of possible future uses of the HRQoL data.
Keywords:
Guidance; Health-related quality of life; Methodology; Relative effectiveness assessment
Authors: Sarah Kleijnen; Teresa Leonardo Alves; Kim Meijboom; Iga Lipska; Anthonius De Boer; Hubertus G Leufkens; Wim G Goettsch Journal: Qual Life Res Date: 2017-04-11 Impact factor: 4.147
Authors: Lisa Van Wilder; Rana Charafeddine; Philippe Beutels; Robin Bruyndonckx; Irina Cleemput; Stefaan Demarest; Delphine De Smedt; Niel Hens; Aline Scohy; Niko Speybroeck; Johan Van der Heyden; Renata T C Yokota; Herman Van Oyen; Joke Bilcke; Brecht Devleesschauwer Journal: Qual Life Res Date: 2021-08-18 Impact factor: 4.147