Do Medicare Claims Measure Cancer Relapse Patients: An External Validation Study

医疗保险索赔是否可以衡量癌症复发患者：一项外部验证研究

基本信息

批准号：
8298162
负责人：
ELIZABETH B LAMONT
金额：
$ 22.12万
依托单位：
HARVARD MEDICAL SCHOOL
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-07-06 至 2014-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8298162
关键词：
Address Adjuvant Chemotherapy Adjuvant Therapy Administrator Agreement Algorithms Area Benefits and Risks Breast Cancer Patient Cancer Relapse Caring Cessation of life Chemotherapy-Oncologic Procedure Clinical Clinical Trials Clinical effectiveness Code Colorectal Colorectal Cancer Communities Computerized Medical Record Conduct Clinical Trials Costs and Benefits Data Data Set Data Sources Decision Making Disease-Free Survival Effectiveness Elderly Elements Enrollment Ensure Event Fruit Future General Hospitals General Population Gold Healthcare Individual Insurance Left Link Logistic Regressions Malignant Neoplasms Malignant neoplasm of lung Massachusetts Measurement Measures Medicare Medicare claim Methods Newly Diagnosed Observational Study Oncologist Operative Surgical Procedures Outcome Patient Representative Patients Pattern Physicians Policies Policy Maker Property Quality of Care Recurrence Reporting Research Research Personnel Resources Sampling Site Source Staging Sum Techniques Testing Time Touch sensation Treatment outcome United States Work base burden of illness cancer care chemotherapy cohort comparative effectiveness drug market efficacy trial follow-up malignant breast neoplasm older patient oncology tool treatment as usual tumor validation studies

项目摘要

DESCRIPTION (provided by applicant): Medicare spent nearly a billion dollars in 2002 on chemotherapy for newly diagnosed elderly breast, colorectal, and lung cancer patients, but surprisingly little is known about the extent to which cancer chemotherapies help or harm such patients. This unsettling paradox is the result of the well-described under- enrollment of the elderly on the clinical trials of chemotherapy. In the absence of trials with representative patients, treating oncologists, patients, and policy-makers are left to extrapolate results of clinical trials conducted in younger and comparatively healthier individuals to the general population with cancer, who tend to be older and have greater comorbid disease burdens. Many basic results of this common extrapolation are unknown. For example oncologists lack even basic observational studies reporting the disease-free survival (DFS) of elderly colorectal (CRC) and breast cancer patients following receipt standard adjuvant chemotherapy. DFS is one of the MOST important end-points in adjuvant chemotherapy in trials, representing the time to cancer relapse or death. Thus, it is relevant to clinicians treating patients in the usual care setting. In this application, our broad aim is to determine whether observational Medicare administrative data may be used to accurately measure DFS in elderly patients with CRC and cancer breast. If it is found to be accurate, the DFS algorithm may meaningful advance research in "cancer in the elderly" which increasing relies on Medicare data sources. In our work, we study two types of Medicare patients, a highly select cohort of 1,539 elderly breast and CRC patients who were treated with adjuvant chemotherapy in the clinical trial setting and a less select patient cohort of 1,250 elderly patients with the same site and stage-specific cancers and treated with nominally identical adjuvant chemotherapy, but in the usual care setting. By studying these two disparate cohorts, we specifically acknowledge that a valid DFS algorithm that performs well in the clinical trial cohort may not perform well in usual care patients, who form the majority of cancer patients in the United States and who are the focus of a wealth of observational Medicare-based studies of cancer in the elderly. If we find that DFS can be accurately measured in Medicare data, we will provide a critical tool to accelerate research in several fields relevance to cancer in the elderly. Among the fruits of these types of the research will be a clearer understanding of (1) trial efficacy vs. effectiveness which is relevant to both clinical trialists and treating physicians; (2) the clinical effectiveness (CE) of different therapies applied to usual care elderly patients; (3) the patterns of cancer care; (4) the quality of care delivered; and (6) the cost and benefit of specific chemotherapy regimens in the elderly. Regarding the latter, if a therapy does not extend DFS or indeed if it accelerates death, Medicare administrators would need to revisit its reimbursement. Developing an accurate DFS algorithm is a predicate to extending our existing work that examines the risks and benefits of cancer chemotherapy in usual care elderly patients, which touches, to some extent, on all area noted above.

描述（由申请人提供）： 2002 年，医疗保险花费了近 10 亿美元用于新诊断的老年乳腺癌、结直肠癌和肺癌患者的化疗，但令人惊讶的是，人们对癌症化疗在多大程度上帮助或伤害这些患者知之甚少。这种令人不安的悖论是化疗临床试验中老年人入组不足的结果。在缺乏代表性患者的试验的情况下，治疗肿瘤学家、患者和政策制定者只能将在较年轻和相对健康的个体中进行的临床试验结果外推到一般癌症患者身上，这些癌症患者往往年龄较大且合并症较多负担。这种常见外推法的许多基本结果都是未知的。例如，肿瘤学家甚至缺乏基本的观察性研究来报告老年结直肠癌 (CRC) 和乳腺癌患者接受标准辅助化疗后的无病生存 (DFS)。 DFS 是试验中辅助化疗最重要的终点之一，代表癌症复发或死亡的时间。因此，它与临床医生在常规护理环境中治疗患者相关。在此应用中，我们的广泛目标是确定观察性医疗保险管理数据是否可用于准确测量患有 CRC 和乳腺癌的老年患者的 DFS。如果发现它是准确的，DFS 算法可能会有意义地推进“老年人癌症”的研究，因为“老年人癌症”越来越依赖医疗保险数据源。在我们的工作中，我们研究了两种类型的医疗保险患者，一个是由 1,539 名在临床试验环境中接受辅助化疗的老年乳腺癌和结直肠癌患者组成的精心挑选的队列，另一个是由 1,250 名具有相同部位和分期的老年患者组成的较少选择的患者队列- 特定癌症并使用名义上相同的辅助化疗进行治疗，但在常规护理环境中进行。通过研究这两个不同的队列，我们特别承认，在临床试验队列中表现良好的有效 DFS 算法可能在常规护理患者中表现不佳，这些患者占美国癌症患者的大多数，也是研究的重点。大量基于医疗保险的老年人癌症观察性研究。如果我们发现可以在医疗保险数据中准确测量 DFS，我们将提供一个关键工具来加速与老年人癌症相关的多个领域的研究。这些类型的研究成果将包括更清楚地了解（1）试验功效与有效性，这与临床试验人员和治疗医生都相关； (2)不同疗法应用于常规护理老年患者的临床有效性(CE)； (3) 癌症护理模式； (4) 提供的护理质量； (6)老年人特定化疗方案的成本和获益。对于后者，如果某种疗法不能延长 DFS 或者加速死亡，医疗保险管理者将需要重新审视其报销。开发准确的 DFS 算法是扩展我们现有工作的前提，该工作检查常规护理老年患者癌症化疗的风险和益处，在某种程度上涉及上述所有领域。