Genomic Research and American Indian Tribal Communities in Oklahoma: Learning From Past Research Misconduct and Building Future Trusting Partnerships.

Research misconduct and consequential harms have been inflicted upon American Indian/Alaska Native communities for decades. To protect their people and culture and to retain oversight over research, many Native communities have established tribal health research and institutional review boards. The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study showcases a successful, trusting research collaboration with tribal nations and academic investigators in Oklahoma. In 2006, the TODAY Study investigators proposed a modification of the study protocol to collect biological specimens from participants for genomic analyses and indefinite storage. Partnering American Indian tribal nations elected not to participate in the genomics collection and repository proposal. Reasons included 1) protection of cultural values, 2) concerns regarding community anonymity, 3) a potential threat to tribal services eligibility, 4) broad informed consent language, and 5) vague definitions of data access and usage. The nations believed the proposed genomics analyses presented a risk of harm to their people and nations without clear benefit. Since the 2006 proposal and the advancement of genomics research, many tribal communities in Oklahoma, appreciating the potential benefits of genomic research, are developing policies regarding oversight of/access to data and biological specimens to mitigate risks and provide members and communities with opportunities to participate in safe and meaningful genomic research.

Collaborative implementation of a community-based exercise intervention with a partnering rural American Indian community.

BACKGROUND: The prevalence and socioeconomic burden of childhood obesity and diabetes has increased rapidly in the United States in the last 30 years. American Indians have the highest prevalence of type 2 diabetes among newly diagnosed youth in the country. Contributing factors include environmental, behavioral, and genetic components. Some American Indian tribal communities have explored innovative ways to combat this epidemic including collaborations with academic centers on community-based research. METHOD: From 2012 to 2017, the University of Oklahoma Health Science Center and the Choctaw Nation of Oklahoma partnered on a National Institutes of Health-funded project to determine if financial incentives would elicit an increase in physical activity in Native youth. This was a community-based behavioral intervention for overweight or obese American Indian youth ages 11-20 living in a rural community at risk for developing diabetes. RESULTS: Tribal leaders and staff identified culturally appropriate strategies to aid implementation of the trial in their community. Their identified implementation strategies helped standardize the study in order to maintain study integrity. The mutually agreed strategies included co-review of the study by tribal and University research review boards (but designation of the Choctaw Nation review board as the "Board of Record"), training of community-based staff on research ethics and literacy, standardization of the informed consent process by videotaping all study information, creation of a viable and culturally appropriate timeline for study implementation, adapting tribal wellness center operations to accommodate youth, and development of effective two-way communication through training sessions, on-site coordination, and bi-monthly conference calls. CONCLUSION: In an effort to partner collectively on a randomized clinical research trial to combat childhood diabetes, tribal leaders and staff implemented strategies that resulted in a culturally appropriate and organized community-based behavioral intervention research project.

Racial Misclassification in Mortality Records Among American Indians/Alaska Natives in Oklahoma From 1991 to 2015.

OBJECTIVE: The primary purpose of this study was to compare age-adjusted mortality rates before and after linkage with Indian Health Service records, adjusting for racial misclassification. We focused on differences in racial misclassification by gender, age, geographic differences, substate planning districts, and cause of death. Our secondary purpose was to evaluate time trends in misclassification from 1991 to 2015. DESIGN: Retrospective, descriptive study. SETTING: Oklahoma. PARTICIPANTS: Persons contained in the Oklahoma State Health Department Vital Records. MAIN OUTCOME MEASURES: To evaluate the age-adjusted mortality ratio pre- and post-Indian Health Service record linkage (misclassification rate ratio) and to evaluate the overall trend of racial misclassification on mortality records measured through annual percent change (APC) and average annual percent change (AAPC). RESULTS: We identified 2 stable trends of racial misclassification upon death for American Indians/Alaska Natives (AI/ANs) from 1991 to 2001 (APC: -0.2%; 95% confidence interval: -1.4% to 1.0%) and from 2001 to 2005 (APC: -6.9%; 95% confidence interval: -13.7% to 0.4%). However, the trend identified from 2005 to 2015 decreased significantly (APC: -1.4%; 95% confidence interval: -2.5% to -0.2%). For the last 5 years available (2011-2015), the racial misclassification adjustment resulted in higher mortality rates for AI/ANs reflecting an increase from 1008 per 100 000 to 1305 per 100 000 with the linkage process. There were an estimated 3939 AI/ANs in Oklahoma who were misclassified as another race upon death in those 5 years, resulting in an underestimation of actual AI/AN deaths by nearly 29%. CONCLUSIONS: An important result of this study is that misclassification is improving; however, this effort needs to be maintained and further improved. Continued linkage efforts and public access to linked data are essential throughout the United States to better understand the burden of disease in the AI/AN population.

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.

Cancer incidence and staging among American Indians in Oklahoma.

BACKGROUND: This study describes overall and site specific cancer incidence among AI/ANs compared to whites in Oklahoma and differences in cancer staging. METHODS: Age-adjusted incidence rates obtained from the Oklahoma Central Cancer Registry are presented for all cancer sites combined and for the most common cancer sites among AI/ANs with comparisons to whites. Percentages of late stage cancers for breast, colorectal, and melanoma cancers are also presented. RESULTS: AI/ANs had a significantly higher overall cancer incidence rate compared to whites (629.8/100,000 vs. 503.3/100,000), with a rate ratio of 1.25 (95% CI: 1.22, 1.28). There was a significant disparity in the percentage of late stage melanoma cancers between 2005 and 2009, with 14.0% late stage melanoma for whites and 20.0% for AI/ANs (p-value:0.03). CONCLUSIONS: Overall, there were cancer disparities between AI/ANs and whites in Oklahoma. Incidence rates were higher among AI/ANs for all cancers and many site specific cancers.

Correction: Using financial incentives to promote physical activity in American Indian adolescents: A randomized controlled trial.

[This corrects the article DOI: 10.1371/journal.pone.0198390.].

Using financial incentives to promote physical activity in American Indian adolescents: A randomized controlled trial.

American Indians (AI) have high prevalence of diabetes in youth and may benefit from increasing physical activity as a strategy to improve metabolic health. We tested whether financial incentives would elicit greater frequency and/or duration of exercise in AI youth at high risk for developing diabetes. Overweight/obese AI boys and girls, 11-20 years old, were instructed to exercise on 3 days/week for 48 weeks at a tribal wellness center. The program was divided into three, 16-week-long phases to test different financial incentive strategies. Within each phase participants were randomly assigned to one of two groups that received different payments for exercise. Phase 1 was designed to test whether the size of the incentive would affect exercise frequency. In Phase 1, the number of exercise sessions did not differ between the group receiving a modest fixed-value payment per exercise session and the group receiving enhanced incentives to exercise more frequently (26 ± 3 versus 28 ± 2 sessions, respectively, p = 0.568). In Phase 2, the provision of an enhanced financial incentive to increase exercise duration resulted longer sessions, as the incentivized and standard payment groups exercised 38 ± 2 versus 29 ± 1 minutes per session (p = 0.002), respectively. In Phase 3, the effect of reducing the incentives on maintenance of exercise behaviors was inconclusive due to high participant withdrawal. Aerobic fitness increased 10% during Phase 1 but was unchanged thereafter. Insulin sensitivity and body composition were unchanged during the study. In conclusion, enhanced financial incentives increased the duration of exercise sessions, but had minimal effects on exercise participation. These results indicate that financial incentives hold promise in motivating previously sedentary, overweight/obese adolescents to exercise longer, but motivating them to sustain an exercise program remains the major challenge. TRIAL REGISTRATION: ClinicalTrials.gov NCT01848353.