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<0.001). QoL results were available in 52.1% in 2017-2021 vs 62.3% in 2012-2016 of primary publications of trials including QoL among endpoints (OR 0.66, 95% CI 0.46 to 0.94, p=0.02). Overall, QoL was analysed and presented in 35.3% of primary publications in 2017-2021 vs 33.0% in 2012-2016 (OR 1.11, 95% CI 0.83 to 1.48, p=0.48). CONCLUSIONS: The proportion of oncology trials including QoL among endpoints increased in 2017-2021 compared with 2012-2016. However, the proportion of primary publications reporting QoL results remains suboptimal.