The National Oncologic PET Registry (NOPR): Design and analysis plan
The National Oncologic PET Registry (NOPR): Design and analysis plan
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DOI：
10.2967/jnumed.107.043687
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发表时间：
2007-11-01
影响因子：
9.3
通讯作者：
Siegel, Barry A.
中科院分区：
文献类型：
--
作者：
Hillner, Bruce E.;Liu, Dawei;Siegel, Barry A.
医疗保险和医疗补助服务中心 (CMS) 提供了一种机制，根据其“证据开发覆盖范围 (CED)”政策，扩大选定有前景技术的覆盖范围。国家肿瘤 PET 登记处 (NOPR) 旨在满足 CED 收集临床和人口数据的要求，从而允许 CIVIS 覆盖 PET 以前未涵盖的癌症类型和适应症。 NOPR 于 2006 年 5 月启用。本报告回顾了 NOPR 的数据收集和分析计划。方法：NOPR 是一个全国性的前瞻性互联网注册中心。所有参与 Medicare 计划的 PET 机构都可以加入 NOPR。 PET 设施负责通过 http://www.web 应用程序收集患者数据并将其输入 NOPR 数据库。 cancerPETregistry.org/。数据是从提出请求的医生处收集的 Pre-PET 和 Post-PET 表格上的。主要研究目标是评估 PET 对转诊医生在扩大的癌症适应症（诊断、分期、再分期、疑似复发和治疗监测）范围内的预期患者管理计划的影响。 NOPR 调查人员只能访问患者和转诊医生都同意将其数据用于研究的病例数据。当 200 名患者被纳入特定组合或 NOPR 运行 1 年后，将按类别（例如分期）对所有癌症的数据进行汇总分析和比较，然后针对特定的高影响类型和适应症（例如胰腺癌分期）进行分析和比较。结论：NOPR 将能够准确评估 PET 对多种癌症适应症的预期患者管理的影响。
The Centers for Medicare and Medicaid Services (CMS) has provided a mechanism for expanded coverage of selected promising technologies under its "coverage with evidence development (CED)" policy. The National Oncologic PET Registry (NOPR) was designed to address the CED requirements for collection of clinical and demographic data to allow for CIVIS coverage of PET for previously noncovered cancer types and indications. The NOPR opened in May 2006. This report reviews the NOPR's data collection and analysis plan. Methods: NOPR is a nationwide prospective internet-based registry. All PET facilities that are participating providers in the Medicare program may enroll in NOPR. The PET facility is responsible for collecting and entering patient data into the NOPR database through a Web application at http://www. cancerPETregistry.org/. Data are collected from the requesting physician on Pre-PET and Post-PETforms. The primary research goal is to assess the effect of PET on referring physicians' plans of intended patient management across the spectrum of expanded cancer indications (diagnosis, staging, restaging, suspected recurrence, and treatment monitoring). The NOPR investigators will have access to data only on cases in which both the patient and the referring physician have consented to allow their data to be used for research. Data will be analyzed and compared in aggregate for all cancers by category (e.g., staging) and then for specific high-impact types and indications (e.g., staging of pancreatic cancer) when 200 patients have been accrued to a specific combination or after the NOPR has been operational for 1 y. Conclusion: The NOPR will allow an accurate assessment of the impact of PET on intended patient management across a wide spectrum of cancer indications.