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Effects of trial design on participation and costs in clinical trials, with an examination of cost analysis methods and data sources.

机译:试验设计对临床试验参与和费用的影响,并检查费用分析方法和数据源。

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摘要

This dissertation comprises a series of studies conducted as part of the Cost of Cancer Treatment Study (COTS). The specific aims include exploring theoretical issues concerning the problem of representativeness in trial design with an explicit investigation of the causes of the under-representation of older adults in clinical cancer trials; comparing sources of data and modeling approaches for estimating treatment costs in health services research; and estimating the impact of clinical trial participation on prescription drug costs.; An exploration of the sample size requirements for power and significance levels in clinical trials suggests that proportional representation of subpopulations in trials will often not allow valid inferences to be drawn about differential treatment effects. Where differential treatment effects in subpopulations are suspected, targeted trials should be undertaken. Under-representation of older cancer could be accounted for by exclusion criteria based on comorbid conditions that disproportionately afflict the elderly.; records, and Medicare claims were compared as data sources for estimating health care utilization rates and costs; the data were compared in terms of completeness and accessibility. Medicare claims contain data on all covered services, including charges, and reimbursements. The costs of Medicare data compare favorably with other sources of comparable quality, but claims data are missing for individuals in managed care and do not include information on prescription drugs. Provider billing records, however, constituted a poor data source, primarily because providers were unwilling or unable to provide these records. Medical records provide accessible, detailed data on service utilization, but not costs. Self-reported health services utilization generally agreed with other sources on inpatient care but not with respect to outpatient services. Cost estimates for utilization measures were derived from administrative data using hedonic regression models.; Prescription drug costs and out-of-pocket drug expenditures were compared for patients enrolled in cancer trials and for similar cancer patients with who did not participate in trials. Trial participation was associated with higher prescription drug costs, but that did not result in any significant difference in out-of-pocket expenditures for participants. These results were robust to a variety of modeling approaches.
机译:本论文包括一系列研究,作为癌症治疗成本研究(COTS)的一部分。具体目标包括探索有关试验设计中代表性问题的理论问题,并明确调查老年人在临床癌症试验中代表性不足的原因。比较数据来源和建模方法以估算卫生服务研究中的治疗费用;以及估计临床试验参与对处方药费用的影响。对临床试验中功效和显着性水平的样本量要求的探索表明,试验中亚群的比例表示通常将无法得出关于不同治疗效果的有效推论。如果怀疑亚群有不同的治疗效果,则应进行有针对性的试验。老年癌症的代表性不足可以由基于折磨老年人的合并症的排除标准来解释。将记录和Medicare索赔作为数据来源进行比较,以估计医疗保健利用率和成本;比较数据的完整性和可访问性。 Medicare索赔包含所有承保服务的数据,包括费用和报销。 Medicare数据的成本与质量可比的其他来源相比还是很有利的,但是管理式医疗服务的个人缺少理赔数据,并且不包括处方药信息。但是,提供商的计费记录构成的数据来源很差,这主要是因为提供商不愿或无法提供这些记录。医疗记录提供有关服务利用率的可访问的详细数据,但不提供费用。自我报告的医疗服务利用情况通常与其他方面的住院医疗服务达成一致,但就门诊服务而言却并非如此。利用享乐成本回归模型从行政数据中得出利用措施的成本估算。比较了参加癌症试验的患者和未参加试验的类似癌症患者的处方药费用和自付费用。参加试验与较高的处方药费用有关,但这并没有导致参加者的自付费用有任何显着差异。这些结果对于各种建模方法都是可靠的。

著录项

  • 作者

    Kilgore, Meredith L.;

  • 作者单位

    The RAND Graduate School.;

  • 授予单位 The RAND Graduate School.;
  • 学科 Health Sciences Public Health.; Health Sciences Pharmacy.
  • 学位 Ph.D.
  • 年度 2004
  • 页码 153 p.
  • 总页数 153
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 R1;R94;
  • 关键词

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