将美国国家癌症研究所资助的肿瘤协作组数据与行政数据源合并，以开发更有效的临床试验分析和比较效果研究平台：来自儿童肿瘤学组的报告。
Merging of the National Cancer Institute-funded cooperative oncology group data with an administrative data source to develop a more effective platform for clinical trial analysis and comparative effectiveness research: a report from the Children's Oncology Group.
机构信息
Children's Hospital of Philadelphia, Philadelphia, PA, USA.
出版信息
Pharmacoepidemiol Drug Saf. 2012 May;21 Suppl 2(Suppl 2):37-43. doi: 10.1002/pds.3241.
PURPOSE
The National Cancer Institute-funded cooperative oncology group trials have improved overall survival for children with cancer from 10% to 85% and have set standards of care for adults with malignancies. Despite these successes, cooperative oncology groups currently face substantial challenges. We are working to develop methods to improve the efficiency and effectiveness of these trials. Specifically, we merged data from the Children's Oncology Group (COG) and the Pediatric Health Information Systems (PHIS) to improve toxicity monitoring, to estimate treatment-associated resource utilization and costs, and to address important clinical epidemiology questions.
METHODS
COG and PHIS data on patients enrolled on a phase III COG trial for de novo acute myeloid leukemia at 43 PHIS hospitals were merged using a probabilistic algorithm. Resource utilization summary statistics were then tabulated for the first chemotherapy course based on PHIS data.
RESULTS
Of 416 patients enrolled on the phase III COG trial at PHIS centers, 392 (94%) were successfully matched. Of these, 378 (96%) had inpatient PHIS data available beginning at the date of study enrollment. For these, daily blood product usage and anti-infective exposures were tabulated and standardized costs were described.
CONCLUSIONS
These data demonstrate that patients enrolled in a cooperative group oncology trial can be successfully identified in an administrative data set and that supportive care resource utilization can be described. Further work is required to optimize the merging algorithm, map resource utilization metrics to the National Cancer Institute Common Toxicity Criteria for monitoring toxicity, to perform comparative effectiveness studies, and to estimate the costs associated with protocol therapy.
目的
美国国家癌症研究所资助的肿瘤协作组试验使癌症患儿的总生存率从 10%提高到 85%，并为恶性肿瘤成人确立了治疗标准。尽管取得了这些成功，但肿瘤协作组目前仍面临着巨大的挑战。我们正在努力开发方法，以提高这些试验的效率和效果。具体而言，我们合并了儿童肿瘤学组（COG）和儿科健康信息系统（PHIS）的数据，以改善毒性监测，估计与治疗相关的资源利用和成本，并解决重要的临床流行病学问题。
方法
我们使用概率算法合并了在 43 家 PHIS 医院进行的 III 期 COG 急性髓细胞白血病新发病例试验中 COG 和 PHIS 的患者数据。然后根据 PHIS 数据列出第一疗程化疗的资源利用汇总统计数据。
结果
在 PHIS 中心参加 III 期 COG 试验的 416 名患者中，有 392 名（94%）成功匹配。其中，378 名（96%）患者在研究入组日期开始时就有住院 PHIS 数据。对于这些患者，我们列出了每日血液制品使用情况和抗感染药物暴露情况，并描述了标准化成本。
结论
这些数据表明，可以在行政数据集成功识别出参加协作组肿瘤学试验的患者，并且可以描述支持性护理资源的利用情况。需要进一步工作来优化合并算法，将资源利用指标映射到国家癌症研究所通用毒性标准以监测毒性，进行比较有效性研究，并估计与方案治疗相关的成本。
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