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 CMS 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-PET forms. The primary research goal is to assess the effect of PET on referring physicians' plans of intended patientmanagement across the spectrumof 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.
- Prospective studies