Development and maintenance of a community-based hepatitis C registry

Objective: To develop a model for community-population- or health system-based registries of all patients with diagnosed hepatitis C, to facilitate clinical care and epidemiologic studies. Study design: Geographically defined, population-based cohort study. Methods: Registry subjects were identified using January 1, 1990, to December 31, 1999, data from the Rochester Epidemiology Project (REP), which lists all diagnoses for Olmsted County residents recorded by clinicians during visits to Olmsted County medical providers. We supplemented diagnostic data with information from laboratory databases that record all hepatitis C testing in Olmsted County. All diagnoses based on the REP and laboratory databases were confirmed by medical record review. Proposed data elements to be included in a hepatitis C registry were identified and defined, and data collection methodology was tested. Results: A total of 355 subjects (62% male) were identified in the total community population of 130,000. Both the diagnostic summary database (n = 309, 87%) and the laboratory database (n = 46, 13%) were important in the identification of subjects for the registry. Nine additional subjects with diagnostic or laboratory evidence of hepatitis C refused the legislatively mandated (Minnesota statute) medical records research authorization and could not be included in the registry. Most desired data elements were available in the medical records. Conclusions: Both medical visit diagnostic summaries (administrative or billing data) and laboratory databases are required to identify subjects with physician-based diagnoses of hepatitis C. Few patients refused the authorization required for inclusion in a research registry.