开发和评估一种多源方法,以延长对随机试验入组的晚期癌症老年患者的死亡率随访。

IF 3.3 Q2 ONCOLOGY
Jennifer L Lund, Jenna Cacciatore, R. Tylock, I. Su, Saloni Sharma, Sharon Peacock Hinton, Sabirah Smith, Molly A Nowels, Xiaomeng Chen, Paul R Duberstein, Laura C Hanson, Supriya G Mohile
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引用次数: 0

摘要

目的死亡率数据可以补充癌症临床试验的主要终点。然而,由于美国没有及时、全面的生命体征数据,因此识别试验完成后的死亡病例具有挑战性。我们开发并评估了一种多源方法来获取临床试验完成后的死亡数据。方法从 2014 年 10 月到 2019 年 3 月,我们招募了 70 岁及以上患有无法治愈的实体瘤或淋巴瘤且≥1 种衰老相关疾病的个体(ClinicalTrials.gov 标识符:NCT02107443 和 NCT02054741)。参与者同意将试验信息链接到外部来源。我们开发了一种扩展死亡捕获的阶梯方法,使用(1)长达 1 年的积极试验随访,(2)与国家死亡指数(NDI)链接,以及(3)讣告搜索,从而生成 5 年生存曲线。在随机抽取的 50 名在试验随访期间死亡的参与者中,我们利用 NDI 和讣告来源估算了死亡数据的敏感性,并按数据来源计算了生存时间。结果两项试验共招募了 1,169 名参与者;平均年龄为 76 岁;46% 为女性;胃肠癌(30%)和肺癌(26%)是最常见的癌症类型。在所有数据源中,随访时间最长超过 7 年;5 年生存率为 18%。总共有 841 例死亡:603 例是在试验随访期间发现的;199 例来自 NDI;39 例来自讣告搜索。与试验数据相比,NDI 和讣告搜索的死亡捕获灵敏度分别为 92% 和 94%,不同数据源计算出的生存时间相似。未来的癌症临床试验应收集必要的同意书和患者身份识别信息,以便进行生命状态关联,从而加深对长期结果的了解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and Evaluation of a Multisource Approach to Extend Mortality Follow-Up for Older Adults With Advanced Cancer Enrolled in Randomized Trials.
PURPOSE Mortality data can complement primary end points from cancer clinical trials. Yet, identifying deaths after trial completion is challenging, as timely and comprehensive vital status data are unavailable in the United States. We developed and evaluated a multisource approach to capture death data after clinical trial completion. METHODS Individuals age 70 years and older with incurable solid tumors or lymphoma and ≥1 aging-related condition were enrolled from October 2014 to March 2019 (ClinicalTrials.gov identifier: NCT02107443 and NCT02054741). Participants provided consent to link trial information to external sources. We developed a stepped approach for extended death capture using (1) active trial follow-up up to 1 year, (2) linkage to the National Death Index (NDI), and (3) obituary searches, thus generating a 5-year survival curve. In a random sample of 50 participants who died during trial follow-up, we estimated sensitivity of death data using NDI and obituary sources and computed survival times by data source. RESULTS The two trials enrolled 1,169 participants; mean age was 76 years; 46% were female; and gastrointestinal cancer (30%) and lung cancer (26%) were the most common cancer types. Across data sources, maximum follow-up was >7 years; 5-year survival was 18%. In total, there were 841 deaths: 603 identified during trial follow-up; 199 from the NDI; and 39 from obituary searches. The sensitivity for death capture was 92% for the NDI and 94% for the obituary searches compared with the trial data, and computed survival times were similar across data sources. CONCLUSION Extending clinical trial mortality follow-up through linkage with external data sources was feasible and accurate. Future cancer clinical trials should collect necessary consent and patient identifiers for vital status linkages that can enhance understanding of longer-term outcomes.
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来源期刊
CiteScore
6.20
自引率
4.80%
发文量
190
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