학술논문
Time trends in health-related quality of life assessment and reporting within publications of oncology randomised phase III trials: a meta-research study
Document Type
article
Author
Raimondo Di Liello; Massimo Di Maio; Francesco Perrone; Fabio Turco; Alessandro Rossi; Piera Gargiulo; Andrea Caglio; Valentina Tuninetti; Eleonora Ghisoni; Laura Marandino; Federica Trastu; Pasquale Lombardi; Annapaola Mariniello; Maria Lucia Reale; Giacomo Aimar; Marco Audisio; Maristella Bungaro; Teresa Gamba; Chiara Paratore
Source
BMJ Oncology, Vol 2, Iss 1 (2023)
Subject
Language
English
ISSN
2752-7948
Abstract
Objective To assess time trends in the inclusion of health-related quality of life (QoL) among study endpoints and in the reporting of QoL results in study publications, randomised phase III oncology trials published between 2017 and 2021 were compared with the trials published in the previous 5 years.Methods and analysis All issues published between 2012 and 2021 by 11 major journals were handsearched for primary publications of phase III trials in adult patients with solid tumours. Trials published in 2017–2021 were compared with trials published in 2012–2016 for three endpoints: (1) proportion of publications including QoL among endpoints out of all the eligible publications; (2) proportion of publications presenting QoL results out of those including QoL among endpoints and (3) proportion of publications presenting QoL data out of all the eligible publications.Results 388 publications between 2017 and 2021 were eligible and compared with 446 publications between 2012 and 2016. QoL was included among endpoints in 67.8% of trials in 2017–2021 vs 52.9% in 2012–2016 (univariate OR 1.87, 95% CI 1.41 to 2.48, p