Marandino Laura, Trastu Federica, Ghisoni Eleonora, Lombardi Pasquale, Mariniello Annapaola, Reale Maria Lucia, Aimar Giacomo, Audisio Marco, Bungaro Maristella, Caglio Andrea, Di Liello Raimondo, Gamba Teresa, Gargiulo Piera, Paratore Chiara, Rossi Alessandro, Tuninetti Valentina, Turco Fabio, Perrone Francesco, Di Maio Massimo
Department of Medical Oncology, IRCCS Ospedale San Raffaele, Milano, Italy.
Department of Oncology, University of Turin, at Ordine Mauriziano Hospital, Torino, Italy.
BMJ Oncol. 2023 Mar 2;2(1):e000021. doi: 10.1136/bmjonc-2022-000021. eCollection 2023.
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.
为评估研究终点中纳入健康相关生活质量（QoL）的时间趋势以及研究出版物中QoL结果的报告情况，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。
手工检索了11种主要期刊在2012年至2021年期间发表的所有期次，以查找成年实体瘤患者III期试验的主要出版物。将2017 - 2021年发表的试验与2012 - 2016年发表的试验在三个终点方面进行比较：（1）在所有符合条件的出版物中，终点中纳入QoL的出版物比例；（2）在终点中纳入QoL的出版物中呈现QoL结果的出版物比例；（3）在所有符合条件的出版物中呈现QoL数据的出版物比例。
2017年至2021年期间有388篇出版物符合条件，并与2012年至2016年的446篇出版物进行比较。2017 - 2021年67.8%的试验将QoL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）。在终点中纳入QoL的试验的主要出版物中，2017 - 2021年有52.1%可获得QoL结果，而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%的主要出版物分析并呈现了QoL，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年终点中纳入QoL的肿瘤学试验比例有所增加。然而，报告QoL结果的主要出版物比例仍不理想。
