Partnering in research: a national research trial exemplifying effective collaboration with American Indian Nations and the Indian Health Service.

Despite the fact that numerous major public health problems have plagued American Indian communities for generations, American Indian participation in health research traditionally has been sporadic in many parts of the United States. In 2002, the University of Oklahoma Health Sciences Center (Oklahoma City, Oklahoma) and 5 Oklahoma American Indian research review boards (Oklahoma City Area Indian Health Service, Absentee Shawnee Tribe, Cherokee Nation, Chickasaw Nation, and Choctaw Nation) agreed to participate collectively in a national research trial, the Treatment Options for Type 2 Diabetes in Adolescence and Youth (TODAY) Study. During that process, numerous lessons were learned and processes developed that strengthened the partnerships and facilitated the research. Formal Memoranda of Agreement addressed issues related to community collaboration, venue, tribal authority, preferential hiring of American Indians, and indemnification. The agreements aided in uniting sovereign nations, the Indian Health Service, academics, and public health officials to conduct responsible and ethical research. For more than 10 years, this unique partnership has functioned effectively in recruiting and retaining American Indian participants, respecting cultural differences, and maintaining tribal autonomy through prereview of all study publications and local institutional review board review of all processes. The lessons learned may be of value to investigators conducting future research with American Indian communities.

Feasibility of integrating research data collection into routine clinical practice using the electronic health record.

PURPOSE: The electronic health record is becoming central to routine medical practice and has the potential to facilitate large scale clinical research. We evaluated the completeness and accuracy of data collection using designated research fields integrated into a semistructured clinical note. We hypothesized that prospective research data collection as part of routine clinical charting is feasible, with a high rate of utilization (greater than 80%) and accuracy (kappa greater than 0.80). MATERIALS AND METHODS: Infants with congenital hydronephrosis were followed prospectively at a single institution. Existing functionality in the electronic health record was used for data collection by creation of 28 different data elements captured from a hydronephrosis note or phrase template. Completeness (percent utilization) was calculated and accuracy was assessed by comparing the structured data to manual chart review. Comparisons were conducted using the chi-square test, with 2-tailed p values <0.05 considered statistically significant. RESULTS: A total of 80 patients were eligible for manual chart review. Data were recorded through template use in 64 patients for an overall completeness of 80.0%. Of 28 elements 17 (60%) demonstrated "almost perfect" agreement (kappa greater than 0.80), and all variables reached at least "moderate" agreement (greater than 0.40). CONCLUSIONS: Integrating research fields into routine clinical practice is feasible by using semistructured clinical templates within an electronic health record. High completion and accuracy rates were captured from a variety of fields within a hydronephrosis template.