The National Oncologic PET Registry (NOPR): design and analysis plan.

UNLABELLED: 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 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.

PET and PET/CT reports: observations from the National Oncologic PET Registry.

UNLABELLED: Our objective was to identify core elements for inclusion in oncologic PET reports and to evaluate a sample of reports in the National Oncologic PET Registry database. METHODS: A list of desirable elements in PET reports was compiled from American College of Radiology and Society of Nuclear Medicine guidelines. A training set of 20 randomly selected reports was evaluated by the 4-physician panel, and the results were used to formulate a consensus approach for assessing report content and quality. Each reviewer then scored 65 randomly selected reports-20 common to all reviewers. The scores were tabulated, and interrater variability was measured for the common cases. RESULTS: Each report was assessed for 34 elements-21 primary and 11 additional questions related to 6 of these primary elements. Among the common cases, there was strong (> or = 0.70) interrater agreement for 30 of 34 elements. Among the unique cases, only 9 elements were included in more than 90% of the reports. Several important elements were not included in more than 40% of the reports: the reason for the study, a description of treatment history, a statement about comparison to other imaging, and time from radiopharmaceutical injection to imaging. CONCLUSION: Essential elements that should be included in oncologic PET reports were missing from many reports. These deficiencies may render the reports less helpful to referring physicians, may lead to misdiagnoses, and may cause coding and billing errors. Interpreting physicians should audit their reports to ascertain that they include appropriate elements necessary for billing compliance and for effective communications with referring physicians.

RTOG physician and research associate attitudes, beliefs and practices regarding clinical trials: implications for improving patient recruitment.

PURPOSE: Timely recruitment and retention of human subjects remains a leading problem in oncology clinical trials even among the national oncology clinical trial cooperative groups. The Radiation Therapy Oncology Group (RTOG) developed an exploratory survey to assess member attitudes, beliefs, and practices (ABPs) towards clinical trials that might influence patient accrual to clinical trials. METHODS: The survey was developed using Survey Monkey(c) and emailed to principal investigators (PIs) and research associates (RAs) at 267 RTOG member institutions. Survey items were selected based on a review of the literature. PI and RA responses were matched by institution to determine whether responses varied due to job responsibilities and/or institutional practices. Principal component analysis was used to achieve variable reduction in further describing respondents' ABPs. RESULTS: PIs and RAs reported similar recruitment concerns [kappa=0.55, 95% CI (0.51, 0.60)]. Five components related to recruitment concerns were identified: presentation of trials to patients, barriers and recruitment risks, staff involvement, access for underrepresented populations, and familial involvement (patient). Nearly one of four (24%) respondents perceived that patients did not understand what randomization means. Staff issues included nearly a third of respondents not having a formal mechanism at their institution for eligibility screening, and similarly, about one of three respondents felt that unrepresented patient populations would benefit from translated consent forms. CONCLUSIONS: Findings of this survey inform RTOG strategies for addressing opportunities for improvement, including clinician/patient education and a best practices tool box that in the future would include successful mechanisms for eligibility screening and recruitment.

The impact of positron emission tomography (PET) on expected management during cancer treatment: findings of the National Oncologic PET Registry.

BACKGROUND: Positron emission tomography (PET) performed during cancer therapy (treatment monitoring) has shown promise for predicting treatment outcome. However, when used for this purpose, PET generally is not considered standard care. Under the Medicare 'coverage with evidence development' policy, PET (and integrated PET/computed tomography) became a covered service for treatment monitoring if prospective registry data were collected. METHODS: The National Oncologic PET Registry collected questionnaire data on intended patient management before and after PET. Data were available from 8240 patients who had 10,497 treatment-monitoring PET scans at 946 centers; these studies were used to monitor chemotherapy alone (82%), radiation therapy alone (6%), or combined-modality treatment (12%). Ovarian, pancreatic, and lung cancers accounted for 37% of the cohort. In 54% of scans, the pre-PET summary stage was metastatic disease. RESULTS: If PET had not been available, then the pre-PET plan would have been other imaging (53%), ongoing treatment (41%), or biopsy or watching (6%). Change in the post-PET intended management was similar in the imaging and treatment groups: 26% to 28% of scans to switching to another therapy, and 16% to 19% scans led to adjustment of the dose or duration of therapy. Changes in management were more frequent if the referring physician judged that the post-PET prognosis was worse rather than improved or unchanged (78% vs 40%). The physicians indicated that PET enabled 91% of their patients to avoid future tests. CONCLUSIONS: Physicians often report plans to modify their therapeutic plans in elderly cancer patients when PET is used for treatment monitoring.

Impact of positron emission tomography/computed tomography and positron emission tomography (PET) alone on expected management of patients with cancer: initial results from the National Oncologic PET Registry.

PURPOSE: Under Medicare's Coverage with Evidence Development policy, positron emission tomography (PET)/computed tomography (CT) and PET became covered services for previously noncovered cancer indications if prospective registry data were collected. The National Oncologic PET Registry (NOPR) was developed to meet these coverage requirements and to assess how PET affects care decisions. METHODS: The NOPR collected questionnaire data from referring physicians on intended patient management before and after PET. After 1 year, the cohort included data from 22,975 studies (83.7% PET/CT) from 1,178 centers. The numbers of scans performed for diagnosis of suspected cancer (or unknown primary cancer), initial cancer staging, restaging, and suspected cancer recurrence were approximately equal. Prostatic, pancreatic and ovarian cancers represented approximately 30% of cases. RESULTS: If PET data were not available, the most common pre-PET plan would have been other imaging. In these patients, the post-PET strategies changed to watching in 37% and treatment in 48%. In patients with planned biopsy before PET, biopsy was avoided in approximately 70%. If the pre-PET strategy was treatment, the post-PET strategy involved a major change in type in 8.7% and goal in 5.6%. When intended management was classified as either treatment or nontreatment, the post-PET plan was three-fold more likely to lead to treatment than nontreatment (28.3% v 8.2%; odds ratio = 3.4; 95% CI, 3.2 to 3.6). Overall, physicians changed their intended management in 36.5% (95% CI, 35.9 to 37.2) of cases after PET. CONCLUSION: This large, prospective, nationally representative registry of elderly cancer patients found that physicians often change their intended management on the basis of PET scan results across the full spectrum of its potential uses.