Time trends in health-related quality of life assessment and reporting within publications of oncology randomised phase III trials: a meta-research study
L. Marandino, F. Trastu, E. Ghisoni, P. Lombardi, A. Mariniello, M. L. Reale, G. Aimar, M. Audisio, M. Bungaro, A. Caglio, R. Di Liello, T. Gamba, P. Gargiulo, C. Paratore, A. Rossi, V. Tuninetti, F. Turco, F. Perrone, M. Di Maio
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引用次数: 3
Abstract
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.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.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).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.
为了评估在研究终点中纳入与健康相关的生活质量(QoL)的时间趋势,以及在研究出版物中报告的生活质量结果,将2017年至2021年发表的随机III期肿瘤学试验与前5年发表的试验进行比较。我们手工检索了2012年至2021年间11个主要期刊发表的关于成年实体瘤患者III期试验的主要出版物。将2017-2021年发表的试验与2012-2016年发表的试验进行三个终点的比较:(1)在所有符合条件的出版物中,终点中包括生活质量的出版物的比例;(2)在包括终点生活质量的出版物中,提供生活质量结果的出版物的比例;(3)在所有符合条件的出版物中,提供生活质量数据的出版物的比例。2017年至2021年期间有388篇论文符合条件,而2012年至2016年期间有446篇论文符合条件。2017-2021年67.8%的试验将生活质量纳入终点,而2012-2016年为52.9%(单因素OR 1.87, 95% CI 1.41至2.48,p<0.001)。2017-2021年,52.1%的主要发表试验可获得生活质量结果,2012-2016年为62.3% (OR 0.66, 95% CI 0.46至0.94,p=0.02)。总体而言,2017-2021年,35.3%的主要出版物对生活质量进行了分析和报道,而2012-2016年为33.0% (OR 1.11, 95% CI 0.83至1.48,p=0.48)。与2012-2016年相比,2017-2021年包括终点生活质量的肿瘤试验比例有所增加。然而,报告生活质量结果的主要出版物的比例仍然不理想。