characteristics can facilitate patient recruitment into large, population-based studies, patient retention, and implementation of randomized intervention trials. Elements integral to the success of clinical research conducted in the managed care setting include selection of research projects of importance to the managed care organization, participation of relevant managed care providers who are interested in a particular research topic, collaboration between academic investigators and the managed care organization, external funding of the research, publication of results in peer-reviewed publications, and incorporation of research results into the clinical practice of the managed care organization. Given these and other factors, the managed care environment can provide unique research opportunities.
Group Health Cooperative of Puget Sound (which is now merged with Kaiser-Permanente) is a large staff model HMO that has more than 500,000 enrollees and the experience and infrastructure needed to conduct research. It has collaborated with the University of Washington on numerous major research projects over the past 15 years. However, less than 25 such managed care organizations exist in the United States.
The principal advantage of working with a research-savvy managed care organization is its ability to provide a large, well-defined, and relatively stable patient population that has uniform access to care, thereby minimizing selection bias and facilitating retention and follow-up in studies. Inpatient and outpatient services are integrated, and support services such as laboratory and pharmacy services are centralized, uniform, and computerized. Moreover, standardization at the physician and clinic levels makes randomization easier. In the case of Group Health Cooperative of Puget Sound, there is also an affiliated research center with experience in supporting the infrastructure for population-based research.
An example of a collaboration between the University of Washington and Group Health Cooperative is a randomized intervention trial to screen women for cervical Chlamydia trachomatis infection for the prevention of pelvic inflammatory disease. Chlamydial infection is the most common bacterial sexually transmitted disease in the United States. The main clinical sequelae are upper genital tract infection and pelvic inflammatory disease. The first step in this project was a cross-sectional study to define the prevalence and risk factors for chlamydial infection among 1,800 female enrollees, which provided a representative demographic profile of women in the Puget Sound region. This cross-sectional study identified a subpopulation in which the disease is prevalent. The second phase of the study involved an intervention trial in which a Chlamydia screening test was randomly administered to women from the high-risk group. All women were then monitored for 12-months. The results showed that screening reduced the incidence of pelvic inflammatory disease by 60 percent.
The collaboration between the University of Washington and a large HMO was the key to success in this clinical research project. The relevance of the study to Group Health Cooperative was vital for the success of the project, as was the inclusion of Group Health Cooperative clinicians during the planning and execution stages. However, external funding was also necessary, because