Projects
Current Projects
Division of Health Services Regulation Support of Databases – This project supports the Division of Health Services Regulation in the development and use of the hospital discharge database and the ambulatory surgery database. The Sheps Center receives data from the State data processor on a quarterly basis, reviews and edits the data, and builds an annual database. These databases are used to support the Division in health planning and related activities.
Principal Investigator: Sandra B. Greene, Dr.P.H.
Funding Source: NC Department of Health and Human Services, Division of Health Services Regulation (formerly Division of Facility Services)
Total Project Period: 11/01/02 – 06/30/10
Implementing Systematic Interventions to Close the Discovery-Delivery Gap – This project examines the implementation, impact, sustainability, and business case of the NCI’s Community Clinical Oncology Program (CCOP), a federally funded national provider-based research network (PBRN) that NIH sees as a model for PBRNs in other disease areas. Specifically, the project is: 1) investigating the implementation of the CCOP in community-based practice settings through in-depth case studies of three newly funded CCOP organizations and a survey of all 50 CCOP organizations; 2) examining the impact of the CCOP on clinical practice through longitudinal analysis of adoption rates of evidence-based cancer therapies by CCOP-affiliated and non-CCOP-affiliated providers using SEER-Medicare data; 3) assessing the factors affecting sustainability of the CCOP in community-based practice settings through a longitudinal analysis of all CCOP organizations active from 1991 through 2003; and 4) investigating the business case for CCOP participation by providers through analysis of financial and statistical data and in-depth case studies.
Principal Investigator: Bryan J. Weiner, Ph.D.
Source: National Cancer Institute, NIH
Total Project Period: 08/15/07 – 06/30/12
CCOP Accrual Performance and Survival - Overview: Through a longitudinal analysis of all CCOP organizations active from 1991 through 2006 using several secondary data sources, the proposed project will investigate the following research questions: (a) how do organizational factors like CCOP size and geographic reach affect CCOP survival and performance; (b) how do network factors like the number and types of clinical trials available and the number and strength of CCOP ties to research bases affect CCOP survival and performance; and (c) how do local environmental factors like provider competition and market consolidation affect CCOP survival and performance? Design. The proposed project will use a single-group, longitudinal design (1991-2007) with the CCOP serving as the unit of analysis. The sample will include CCOPs that serve an adult population and serve at least one Metropolitan Statistical Area (MSA). Sample size averages 50 CCOPs per year, even with entries and exits from the program during the observation period; thus, statistical analysis will be based on approximately 800 CCOP observation-years. Data Sources. The NCI’s Cancer Therapy Evaluation Program (CTEP) clinical trials database will supply data on CCOP organizations’ clinical trials accrual. Several secondary data sources will provide data on independent and control variables. These include: (a) CCOP grant progress reports, (b) the American Hospital Association Annual Survey of Hospitals, (c) the Area Resource Files, and (d) the American Medical Association Physician Masterfile. Measures. CCOP accrual performance will be measured as treatment trial accrual and cancer prevention and control trial accrual. Survival will be measured as whether or not the CCOP exited the CCOP program. Primary independent variables will include measures of resource availability (e.g., inputs like clinical trials, study participants, and health professionals), resource predictability (e.g., changes in hospital/provider market structure), and CCOP organization productive capability (e.g., leadership stability, staffing turnover, and maintenance of implementation policies and practices). The Appendix describes the proposed measures. Data Analysis. Data analysis will include univariate, bivariate, and bivariate trend analysis. Longitudinal regression analysis will be used to understand how the multiple factors affecting CCOP clinical trial enrollment covary, while controlling for the separate affects of time and time-invariant omitted variables, as well as random-effects that vary over time. Given adequate sample size and statistical power, survival analysis will be used to examine factors associated with program dropout (CCOP dissolution).
Principal Investigator: William Carpenter, Ph.D.
Funding Source: National Cancer Institute
Total Project Period: 9/24/08 - 3/23/10
Cancer Multi-Center Research Consortium (Master Task Order) - A pressing need exists for timely, evidence-based information to guide cancer care delivery. Although new cancer diagnostic and treatment interventions are subject to rigorous evaluation in clinical trials, clinicians often use these interventions in a broader spectrum of cancer patients, clinical settings, and disease conditions than found in clinical trials 1, 2. Moreover, clinical trials are rarely designed to evaluate new interventions on multiple endpoints, detect uncommon adverse events, or assess health outcomes over longer periods of time 1, 3. Consequently, clinicians and other stakeholders attempting to make evidence-based decisions confront substantial gaps in knowledge about the safety, effectiveness, and appropriateness of cancer diagnostic and treatment interventions as they are actually used in clinical practice. The University of North Carolina at Chapel Hill (UNC) welcomes the opportunity to respond to the Agency for Healthcare Research and Quality’s (AHRQ) call to establish a consortium to conduct comparative effectiveness research in cancer. In addition to participating as an affiliate research center, UNC proposes to serve as the coordinating center for the consortium.
Principal Investigator: Michael D. Murray, PharmD, MPH; TASK PI: William Carpenter, Ph.D
Primary Funding Source: AHRQ
Total Project Period: 9/04/08-9/30/10
Work Assignment #1
Health Outcomes of Colorectal Cancer Chemotherapy - Chemotherapy is a cornerstone of treatment for patients with colorectal cancer (CRC). For patients with metastatic disease, it is the primary treatment modality and prolongs overall survival. For patients who have had surgical resection and are found to have stage III disease, adjuvant chemotherapy decreases the likelihood of disease recurrence. Since 2002, several new agents for CRC have been approved by the Food and Drug Administration (FDA) based on clinical trials demonstrating improvement in overall survival. In particular, the “FOLFOX” regimen, combining 5fluorouracil (5FU) and oxaliplatin, has demonstrated efficacy for stage III cancers, while FOLFOX as well as an analogous regimen containing irinotecan (FOLFIRI) and monoclonal antibodies including bevacizumab and cetuximab have demonstrated efficacy for metastatic disease. However, these randomized clinical trials have involved patient populations that were substantially younger and healthier than the broader population with advanced colorectal cancer. Elderly patients and patients with co-morbidities may respond differently to chemotherapy and be at higher risk for adverse events. Because evidence is limited on the effectiveness and safety of these chemotherapy regimens outside of the clinical trial setting, formulating treatment recommendations or clinical practice guidelines is challenging. Working collaboratively with researchers from the Brigham and Women's Hospital and the Agency for Healthcare Research and Quality, we will address this critical gap in knowledge by combining observational data from multiple sources to determine whether the current popular treatments for CRC are safe and effective when used in populations poorly represented in clinical trials. These data will allow us to observe the benefits and harms of colon cancer chemotherapy when it is widely adopted in clinical practice. We will examine specific treatment regimens including no treatment, 5FU-based treatments alone, the FOLFOX and FOLFIRI regimens as well as combination approaches that include the recently-approved monoclonal antibodies. We will examine overall survival, progression-free survival, and will also evaluate treatment toxicities by measuring 60-day mortality, hospitalizations, and emergency department use that occur during active treatment. We will re-examine individual patient data from available clinical trials, and directly compare the clinical trials-based (efficacy) and the community-based (effectiveness) experiences. We will leverage detail present in our observational data sets to minimize confounding and will apply advanced statistical techniques to minimize the impact of confounding on our systematic evaluation of comparative effectiveness.
Principal Investigator: Michael D. Murray, PharmD, MPH; TASK PI: William Carpenter, Ph.D
Primary Funding Source: AHRQ
Total Project Period: 2/25/09-9/15/09
Work Assignment #2
Analytic Briefs for Supporting Comparative Effectiveness Research and Systematic Reviews in Cancer: Phase 1 Identifying Options for Implementation- Specific to this Work Assignment (WA2), in recent years, the landscape of cancer care has changed greatly due to a multitude of these new interventions having entered the market, and more so than ever before, health and pharmaceutical providers need assistance in developing evidence to inform new policies and strategies for delivering appropriate care to a growing population of individuals with cancer. There is little information that examines the overall use, or short-term or long-term effectiveness of pharmacologic treatments, as well as devices and diagnostics used in cancer diagnosis and treatment. With the growing number of databases available for research to study the adoption of these interventions and their clinical and comparative effectiveness, there is also growing opportunity to systematically approach the need to develop the evidence base on utilization and effectiveness.The objective of WA2 is to identify cancer care interventions for systematic study, and develop multiple options for new, online reporting that AHRQ may publish to advance knowledge about the utilization and comparative effectiveness of medical interventions used in cancer treatment. In addressing this objective, investigators at the UNC CanDEcIDE will partner with investigators at the Brigham and Women's Hospital (BWH) CanDEcIDE coordinating center, AHRQ, and the University of Pennsylvania (Penn) and Acumen DEcIDE analytic centers to identify options for a new series of electronic reports on the different classes of drugs which have commonly been used in the treatment of cancer, as well as newer and other therapeutic agents.
Principal Investigator: Michael D. Murray, PharmD, MPH; TASK PI: William Carpenter, Ph.D
Primary Funding Source: AHRQ
Total Project Period: 2/16/09-3/31/09
Work Assignment #3
Evaluating Outcomes of PET Scanning Using the National Oncologic PET Registry
This is a task order contract assignment under the DEcIDE Cancer Multi-Center Research Consortium program to develop a research protocol to evaluate the outcomes of using positron emission tomography (PET) imaging for cancers and indication covered under the Coverage with Evidence Development ( CED) decision by the Centers for Medicare & Medicaid Services (CMS). This protocol will use prospective data collection from the National Oncologic PET Registry (NOPR) to identify cases undergoing PET imaging and to use this registry for relevant data.
Principal Investigator: Michael D. Murray, PharmD, MPH; TASK PI: William Carpenter, Ph.D
Primary Funding Source: AHRQ
Total Project Period: 3/31/09-5/31/09
