Grabner Michael, Molife Cliff, Wang Liya, Winfree Katherine B, Cui Zhanglin Lin, Cuyun Carter Gebra, Hess Lisa M
HealthCore Inc, Wilmington, DE, United States.
Eli Lilly and Company, Indianapolis, IN, United States.
JMIR Cancer. 2021 Apr 12;7(2):e23161. doi: 10.2196/23161.
The integration of data from disparate sources could help alleviate data insufficiency in real-world studies and compensate for the inadequacies of single data sources and short-duration, small sample size studies while improving the utility of data for research.
This study aims to describe and evaluate a process of integrating data from several complementary sources to conduct health outcomes research in patients with non-small cell lung cancer (NSCLC). The integrated data set is also used to describe patient demographics, clinical characteristics, treatment patterns, and mortality rates.
This retrospective cohort study integrated data from 4 sources: administrative claims from the HealthCore Integrated Research Database, clinical data from a Cancer Care Quality Program (CCQP), clinical data from abstracted medical records (MRs), and mortality data from the US Social Security Administration. Patients with lung cancer who initiated second-line (2L) therapy between November 01, 2015, and April 13, 2018, were identified in the claims and CCQP data. Eligible patients were 18 years or older and received atezolizumab, docetaxel, erlotinib, nivolumab, pembrolizumab, pemetrexed, or ramucirumab in the 2L setting. The main analysis cohort included patients with claims data and data from at least one additional data source (CCQP or MR). Patients without integrated data (claims only) were reported separately. Descriptive and univariate statistics were reported.
Data integration resulted in a main analysis cohort of 2195 patients with NSCLC; 2106 patients had CCQP and 407 patients had MR data. The claims-only cohort included 931 eligible patients. For the main analysis cohort, the mean age was 62.1 (SD 9.27) years, 48.56% (1066/2195) were female, the median length of follow-up was 6.8 months, and for 37.77% (829/2195), death was observed. For the claims-only cohort, the mean age was 66.6 (SD 12.69) years, 52.1% (485/931) were female, the median length of follow-up was 8.6 months, and for 29.3% (273/931), death was observed. The most frequent 2L treatment was immunotherapy (1094/2195, 49.84%), followed by platinum-based regimens (472/2195, 21.50%) and single-agent chemotherapy (441/2195, 20.09%); mean duration of 2L therapy was 5.6 (SD 4.9, median 4) months. We describe challenges and learnings from the data integration process, and the benefits of the integrated data set, which includes a richer set of clinical and outcome data to supplement the utilization metrics available in administrative claims.
The management of patients with NSCLC requires care from a multidisciplinary team, leading to a lack of a single aggregated data source in real-world settings. The availability of integrated clinical data from MRs, health plan claims, and other sources of clinical care may improve the ability to assess emerging treatments.
整合来自不同来源的数据有助于缓解真实世界研究中的数据不足问题,弥补单一数据源以及短期、小样本量研究的不足,同时提高数据在研究中的效用。
本研究旨在描述和评估一个整合来自多个互补来源的数据以开展非小细胞肺癌(NSCLC)患者健康结局研究的过程。整合后的数据集还用于描述患者人口统计学特征、临床特征、治疗模式和死亡率。
这项回顾性队列研究整合了4个来源的数据:HealthCore综合研究数据库的行政索赔数据、癌症护理质量项目(CCQP)的临床数据、提取的病历(MR)临床数据以及美国社会保障管理局的死亡率数据。在索赔数据和CCQP数据中识别出2015年11月1日至2018年4月13日期间开始二线(2L)治疗的肺癌患者。符合条件的患者年龄在18岁及以上,且在2L治疗中接受了阿特珠单抗、多西他赛、厄洛替尼、纳武单抗、帕博利珠单抗、培美曲塞或雷莫西尤单抗治疗。主要分析队列包括有索赔数据且至少有一个其他数据源(CCQP或MR)数据的患者。没有整合数据(仅有索赔数据)的患者单独报告。报告了描述性和单变量统计结果。
数据整合产生了一个由2195例NSCLC患者组成的主要分析队列;2106例患者有CCQP数据,407例患者有MR数据。仅有索赔数据的队列包括931例符合条件的患者。对于主要分析队列,平均年龄为62.1(标准差9.27)岁,48.56%(1066/2195)为女性,中位随访时间为6.8个月,37.77%(829/2195)的患者观察到死亡。对于仅有索赔数据的队列,平均年龄为66.6(标准差12.69)岁,52.1%(485/931)为女性,中位随访时间为8.6个月,29.3%(273/931)的患者观察到死亡。最常见的2L治疗是免疫疗法(1094/2195,49.84%),其次是铂类方案(472/2195,21.50%)和单药化疗(441/2195,20.09%);2L治疗的平均持续时间为5.6(标准差4.9,中位数4)个月。我们描述了数据整合过程中的挑战和经验教训,以及整合数据集的益处,该数据集包括更丰富的临床和结局数据,以补充行政索赔中可用的利用指标。
NSCLC患者的管理需要多学科团队的护理,导致在真实世界环境中缺乏单一的汇总数据源。来自MR、健康计划索赔和其他临床护理来源的整合临床数据的可用性可能会提高评估新出现治疗方法的能力。