What's New
Announcement
Posted on 6.15.05
Reprinted from The International Society for Pharmacoepidemiology's Scribe, 2nd Quarter 2005, Volume 9, Number 2, www.pharmacoepi.org.
The HMO Research Network Center for Education and Research on Therapeutics (CERTs)
By Richard Platt, MD, MS
The HMO Research Network Center for Education and Research in Therapeutics (CERTs) advances population-based health and health care research in the public domain by using health plans' defined populations, their clinical systems, and their data resources to address important medical care and public health questions. This CERTs center is one of seven centers created in response to a congressional mandate in 1999. The mission of the CERTs includes research and education to advance the optimal use of drugs, medical devices, and biological products (http://www.certs.hhs.gov).
The HMO Research Network CERTs is comprised of 10 member HMOs: Group Health Cooperative in Washington State, Harvard Pilgrim Health Care in Massachusetts, HealthPartners Research Foundation in Minnesota, Kaiser Permanente Colorado, Kaiser Permanente Georgia, Kaiser Permanente Northern California, Kaiser Permanente Northwest in Oregon, Lovelace Health System in New Mexico, Meyers Primary Care Institute/Fallon Healthcare in Massachusetts, and UnitedHealthcare. The HMOs serve geographically and ethnically diverse populations with a broad age range and relatively low turnover rate; together, the health plans have nearly 11 million members, representing approximately 4 percent of the U.S. population, enough to address many topics that are beyond the power of their individual populations. Investigators from each institution have the opportunity, and are encouraged, to lead studies.
HMO RESEARCH NETWORK DATA DEVELOPMENT
The general strategy for accomplishing research goals within the HMO Research Network CERTs is for each health plan-based research group to work with its own data. We developed data and analysis strategies to ensure consistent implementation of study protocols across multiple sites, respect for proprietary nature of health plans' data, and compliance with Health Insurance Portability and Accountability Act (HIPAA).
Coordination and data development infrastructure enables both observational, nested case-control and intervention studies efficiently across HMOs. Since its establishment in 1999, this network has demonstrated its ability to assess therapeutics for adults and children, conduct cost-effectiveness analyses, drug policy reviews, assess prescribing practices, test interventions to improve care, and to disseminate proven care improvement methods to clinicians and to patients. Examples of such studies include:
- Assessing drug prescribing patterns: Andrade and colleagues noted that approximately 65 percent of women who delivered received a prescription drug other than vitamin or mineral supplement during the 270 days before delivery. Nearly half of pregnant women are prescribed drugs from categories C (no evidence supporting safety), D (having positive evidence of fetal risk, but benefits of use may be acceptable), or X (definite fetal risks based on human or animal studies, risk of using the drugs clearly outweighs any possible benefit) of the U.S. FDA risk classification system. This study highlights the importance of understanding the effects of these medications on the developing fetus and on the pregnant women.
- Postmarketing drug safety assessment: Chan et al evaluated the incidence of serious acute liver injury among patients using hypoglycemic agents.
- Intervention studies: we are evaluating real time alerts to prevent inappropriate prescribing in environments utilizing computerized physician order entry and to improve the adherence to laboratory monitoring guidelines.
- Drug policy studies: Roblin et al found a 19 percent decrease in adherence to oral hypoglycemic therapy following increase in co-payments by more than $10 per month.
- Cluster Randomized Trials: currently an intervention to improve adherence to beta-blocker use in HMO members post MI is underway. Intervention was randomized by provider practice.
We anticipate placing additional emphasis on understanding comparative effectiveness of different therapies with similar indications, and improving the safe and effective use of therapies through better decision support systems both for clinicians and patients. We invite collaboration with ISPE members and others in the scientific community.
Editor's Note: This is the third in a series of articles appearing in the Scribe newsletter each featuring a different CERTs center.