健康相关生活质量评估和报告的不足:2012 年至 2016 年发表的肿瘤随机 III 期试验的系统评价。
Deficiencies in health-related quality-of-life assessment and reporting: a systematic review of oncology randomized phase III trials published between 2012 and 2016.
机构信息
Department of Oncology, University of Turin, Turin, Italy; Division of Medical Oncology, Candiolo Cancer Institute, FPO, IRCCS, Candiolo, Italy.
Department of Oncology, University of Turin, Turin, Italy; Division of Medical Oncology, San Luigi Gonzaga Hospital, Orbassano, Italy.
出版信息
Ann Oncol. 2018 Dec 1;29(12):2288-2295. doi: 10.1093/annonc/mdy449.
Quality of life (QoL) is a relevant end point and a topic of growing interest by both scientific community and regulatory authorities. Our aim was to review QoL prevalence as an end point in cancer phase III trials published in major journals and to evaluate QoL reporting deficiencies in terms of under-reporting and delay of publication. All issues published between 2012 and 2016 by 11 major journals were hand-searched for primary publications of phase III trials in adult patients with solid tumors. Information about end points was derived from paper and study protocol, when available. Secondary QoL publications were searched in PubMed. In total, 446 publications were eligible. In 210 (47.1%), QoL was not included among end points. QoL was not an end point in 40.1% of trials in the advanced/metastatic setting, 39.7% of profit trials and 53.6% of non-profit trials. Out of 231 primary publications of trials with QoL as secondary or exploratory end point, QoL results were available in 143 (61.9%). QoL results were absent in 37.6% of publications in the advanced/metastatic setting, in 37.1% of profit trials and 39.3% of non-profit trials. Proportion of trials not including QoL as end point or with missing QoL results was relevant in all tumor types and for all treatment types. Overall, 70 secondary QoL publications were found: for trials without QoL results in the primary publication, probability of secondary publication was 12.5%, 30.9% and 40.3% at 1, 2 and 3 years, respectively. Proportion of trials not reporting QoL results was similar in trials with positive results (36.5%) and with negative results (39.4%), but the probability of secondary publication was higher in positive trials. QoL is not included among end points in a relevant proportion of recently published phase III trials in solid tumors. In addition, QoL results are subject to significant under-reporting and delay in publication.
生活质量(QoL)是一个相关的终点,也是科学界和监管机构日益关注的话题。我们的目的是综述在主要期刊上发表的癌症 III 期试验中 QoL 作为终点的流行情况,并评估 QoL 报告在漏报和延迟发表方面的缺陷。检索了 2012 年至 2016 年期间 11 种主要期刊上发表的所有问题,寻找成人实体瘤 III 期试验的主要出版物。在可能的情况下,从论文和研究方案中获取终点信息。在 PubMed 中搜索次要的 QoL 出版物。共有 446 篇论文符合条件。在 210 篇(47.1%)中,QoL 未被列入终点。在晚期/转移性环境中,40.1%的试验、40.1%的盈利性试验和 53.6%的非营利性试验没有将 QoL 作为终点。在 231 篇将 QoL 作为次要或探索性终点的试验的主要出版物中,有 143 篇(61.9%)提供了 QoL 结果。在晚期/转移性环境中,37.6%的出版物、37.1%的盈利性试验和 39.3%的非营利性试验中没有 QoL 结果。在所有肿瘤类型和所有治疗类型中,不将 QoL 作为终点或缺乏 QoL 结果的试验比例都是相关的。总体而言,共发现 70 篇次要的 QoL 出版物:对于主要出版物中没有 QoL 结果的试验,在 1、2 和 3 年时分别有 12.5%、30.9%和 40.3%的可能性进行二次发表。阳性结果(36.5%)和阴性结果(39.4%)试验中未报告 QoL 结果的试验比例相似,但阳性试验的二次发表概率更高。在最近发表的实体瘤 III 期试验中,有相当比例的试验未将 QoL 作为终点。此外,QoL 结果存在严重的漏报和发表延迟。