RTI DEcIDE Center Completed Projects
Infrastructure to Monitor Utilization and Outcomes of Gene-Based Applications: An Assessment
In this project, RTI DecIDE staff assessed existing systems and databases for monitoring the use and outcomes of gene-based clinical applications in the health care system, including tests and related interventions. Based on information gained through a targeted literature and Web site search, stakeholder interviews, and expert discussions at a specially convened working group meeting, the team made numerous recommendations about establishing appropriate and practical systems that might be used to assess gene-based applications. Needed steps include developing standard codes for genetic tests and database architecture standards (e.g., for database interoperability), addressing concerns about privacy and confidentiality, and reducing the proprietary and regulatory barriers that inhibit sharing of data. Other recommendations centered on additional research and development, including: improving coding of gene-based tests (test type, reason for the test, and test results); developing or adopting standards for the proper collection and storage of data from genetic testing laboratories; exploring the possibility of adding questions to ongoing surveys or developing new surveys to monitor the availability of genetic testing centers, adequate counseling, and barriers to accessing counseling services; considering a periodic national survey of genetic testing laboratories; and developing pilot studies for a small set of diseases and tests.
For additional information on this project, please contact Nedra Whitehead. For free access to the report, go to http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=nr&ProcessID=63
Emerging Methods in Comparative Effectiveness and Safety: Symposium and Journal Supplement
To assist AHRQ efforts in information transfer and dissemination from the DEcIDE efforts and those of other ARHQ programs, the RTI DEcIDE Center carried out a multifaceted task ultimately focused on new and emerging methods for conducting studies on comparative effectiveness and drug safety (particularly adverse drug events). We planned and convened a 1.5-day symposium in mid-2006 on drug safety, patient safety, and therapeutic effectiveness, with specific attention to pharmaceuticals, especially in light of the Medicare Modernization Act and the onset of the Medicare Part D benefit for outpatient drugs. We then organized a set of about 25 papers to be published in a supplement to Medical Care in October 2007; entitled "Comparative Effectiveness and Safety: Emerging Methods," it draws specifically on papers presented at the symposium. Key papers focus on (1) using new types of experimental designs, including cluster randomization, delayed designs, pragmatic trials, and practice-based investigations; (2) efficiently employing different types of databases -- e.g., Department of Veterans Affairs files, Centers for Disease Control and Prevention surveillance files, Medicaid claims data, and state hospital data -- to study initiation, persistence, and adherence with respect to medication regimens, and the benefits and adverse events of pharmaceutical use; and (3) inventing or refining ways to lower threats to validity of analyses that use administrative or other observational data, particularly through propensity scoring, inverse probability weighting, risk adjustment, and direct or indirect methods for synthesizing comparative effectiveness information.
For additional information on this project, please contact Kathleen Lohr, PhD. For free access to the supplement papers, go to http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=nr&ProcessID=32.
Medicare Prescription Drug Data Development: Methods for Improving Patient Safety and Pharmacovigilance Using Observational Data
In this first project, we developed a methodological toolbox and data analytical framework for pharmacoepidemiologic research using population-based claims and administrative data sources. The target pharmaceuticals were Alzheimer's (antidementia) drugs.
We first critically assessed current measures and techniques used to explore drug and patient safety issues, especially from claims and other electronic health care databases. From this literature scan and with feedback from AHRQ and other experts (at the University of North Carolina, for example, which has a companion project), we developed an evidence-based approach to standardizing drug prescription statistics and drug safety measures for this particular class of drugs. In conjunction with our DEcIDE partners in Utah, particularly those in the Utah Department of Health, Office of Health Statistics, we developed a database that links pharmacy, outpatient, inpatient, physician office, and emergency department claims. This "simulated" database is similar to the one that will be available from the Centers for Medicare and Medicaid Services once the Medicare Prescription Drug Benefit is operable. Using these data, we conducted pilot studies to examine the feasibility and other characteristics of prototypical measures of drug and patient safety.
For additional information on this project, please contact Kathleen Lohr, PhD. For free access to the report, Improving patient safety and pharmacovigilance: methods using observational data and cohort studies, Effective Health Care Research Report No. 6., go to http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=nr&ProcessID=31
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