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Health equity is the state in which everyone has fair and just opportunities to attain their highest level of health. The field of human genomics has fallen short in increasing health equity, largely because the diversity of the human population has been inadequately reflected among participants of genomics research. This lack of diversity leads to disparities that can have scientific and clinical consequences. Achieving health equity related to genomics will require greater effort in addressing inequities within the field. As part of the commitment of the National Human Genome Research Institute (NHGRI) to advancing health equity, it convened experts in genomics and health equity research to make recommendations and performed a review of current literature to identify the landscape of gaps and opportunities at the interface between human genomics and health equity research. This Perspective describes these findings and examines health equity within the context of human genomics and genomic medicine.
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Genômica , Equidade em Saúde , Humanos , Genômica/métodos , Estados Unidos , Genoma Humano , National Human Genome Research Institute (U.S.)RESUMO
Health disparities are driven by unequal conditions in the environments in which people are born, live, learn, work, play, worship, and age, commonly termed the Social Determinants of Health (SDoH). The availability of recommended measurement protocols for SDoH will enable investigators to consistently collect data for SDoH constructs. The PhenX (consensus measures for Phenotypes and eXposures) Toolkit is a web-based catalog of recommended measurement protocols for use in research studies with human participants. Using standard protocols from the PhenX Toolkit makes it easier to compare and combine studies, potentially increasing the impact of individual studies, and aids in comparability across literature. In 2018, the National Institute on Minority Health and Health Disparities provided support for an initial expert Working Group to identify and recommend established SDoH protocols for inclusion in the PhenX Toolkit. In 2022, a second expert Working Group was convened to build on the work of the first SDoH Working Group and address gaps in the SDoH Toolkit Collections. The SDoH Collections consist of a Core Collection and Individual and Structural Specialty Collections. This article describes a Basic Protocol for using the PhenX Toolkit to select and implement SDoH measurement protocols for use in research studies. © 2024 The Authors. Current Protocols published by Wiley Periodicals LLC. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA. Basic Protocol: Using the PhenX Toolkit to select and implement SDoH protocols.
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Academias e Institutos , Determinantes Sociais da Saúde , Humanos , Consenso , Estudos Epidemiológicos , Empregados do GovernoRESUMO
BACKGROUND: Food insecurity is an important social determinant of health that was exacerbated by the COVID-19 pandemic. Both food insecurity and COVID-19 infection disproportionately affect racial and ethnic minority groups, particularly American Indian and Alaska Native communities; however, there is little evidence as to whether food insecurity is associated with COVID-19 infection or COVID-19 preventive behaviors such as vaccination uptake. The purpose of this study was to evaluate associations between food insecurity, COVID-19 infection, and vaccination status among urban American Indian and Alaska Native adults seen at 5 clinics serving urban Native people. METHODS: In partnership with health organizations in Alaska, Colorado, Kansas, Minnesota, and New Mexico, the study team conducted a cross-sectional survey in 2021 to assess food security status and attitudes, barriers, and facilitators for COVID-19 testing and vaccination. Logistic regression was used to examine the association of food security status with sociodemographic factors and COVID-19 infection and vaccination status. Marginal standardization was applied to present results as prevalence differences. RESULTS: Among 730 American Indian and Alaska Native adults, the prevalence of food insecurity measured during the pandemic was 38%. For participants who reported persistent food security status before and during the pandemic (n = 588), the prevalence of food insecurity was 25%. Prevalence of COVID-19 infection and vaccination did not vary by food security status after adjustment for confounders. CONCLUSIONS: High rates of food insecurity among American Indian and Alaska Native communities likely increased during the COVID-19 pandemic. However, despite the high prevalence of food insecurity, community-led efforts to reduce COVID-19 infection and increase vaccination uptake across Indian Health Service and Tribal healthcare facilities may have mitigated the negative impacts of the pandemic for families experiencing food insecurity. These successful approaches serve as an important reference for future public health efforts that require innovative strategies to improve overall health in American Indian and Alaska Native communities.
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Indígena Americano ou Nativo do Alasca , COVID-19 , Insegurança Alimentar , Adulto , Humanos , COVID-19/epidemiologia , Teste para COVID-19 , Estudos Transversais , PandemiasRESUMO
Objective: Create a longitudinal, multi-modal and multi-level surveillance cohort that targets early detection of symptomatic and asymptomatic COVID-19 cases among Native Hawaiian and Pacific Islander adults in the Continental US and identify effective modalities for participatory disease surveillance and sustainably integrate them into ongoing COVID-19 and other public health surveillance efforts. Materials and methods: We recruited cohorts from three sites: Federal Way, WA; Springdale, AR; and remotely. Participants received a survey that included demographic characteristics and questions regarding COVID-19. Participants completed symptom checks via text message every month and recorded their temperature daily using a Kinsa smart thermometer. Results: Recruitment and data collection is ongoing. Presently, 441 adults have consented to participate. One-third of participants were classified as essential workers during the pandemic. Discussion: Over the past 18 months, we have improved our strategies to elicit better data from participants and have learned from some of the weaknesses in our initial deployment of this type of surveillance system. Other limitations stem from historic inequities and barriers which limited Native Hawaiian and Pacific Island representation in academic and clinical environments. One manifestation of this was the limited ability to provide study materials and support in multiple languages. We hope that continued partnership with the community will allow further opportunities to help restore trust in academic and medical institutions, thus generating knowledge to advance health equity. Conclusion: This participatory disease surveillance mechanism complements traditional surveillance systems by engaging underserved communities. We may also gain insights generalizable to other pathogens of concern.
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INTRODUCTION: Alaska Native and American Indian (ANAI) people have a smoking prevalence of 23%. Nicotine metabolite ratio (NMR) and genetic testing may enable tailored selection of tobacco cessation medication. AIMS AND METHODS: The purpose of this study was to evaluate the relative contributions of NMR, cessation medication, demographics, and tobacco use history to cessation. Participants were recruited into an observational cohort study consisting of a baseline visit prior to their quit date and 6-week follow-up. Demographic and tobacco use surveys and blood, urine, and breath samples were collected at each visit. Electronic health records were queried for cessation medications. NMR was categorized into slow or normal nicotine metabolism phenotypes (<0.31 andâ ≥â 0.31, respectively). The main outcome was cessation at 6 weeks. Analyses consisted of descriptive statistics, medication and phenotype concordance, and estimates of relative risk (RR) of quitting. RESULTS: We enrolled 151 ANAI adults who smoked cigarettes daily. Two-thirds had normal nicotine metabolism phenotype. Retrospective medication and phenotype concordance was 39%. The overall quit rate was 25%. No demographic factors or tobacco use history were associated with quit success. Varenicline and bupropion increased the likelihood of quitting (RRâ =â 2.93 [1.42, 6.03] and RRâ =â 2.52 [1.12, 5.64], respectively) compared to nicotine replacement therapy. Non-optimal medication and phenotype concordance decreased likelihood of quit success (RRâ =â 0.44 [0.22, 0.91]) compared to optimal concordance. CONCLUSIONS: This exploratory study found associations between quit success and tobacco cessation medication as well as medication and phenotype concordance. Additional research is needed to assess use of NMR for treatment selection among ANAI people. IMPLICATIONS: These results broadly support additional community-engaged research to improve medication and phenotype concordance in tribal health settings. Such future research on implementing meditcation and phenotype concordance holds promise to improve expectations, quit success, and health outcomes amongst individuals attempting to quit smoking.
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Abandono do Hábito de Fumar , Fatores Sociodemográficos , Adulto , Humanos , Indígena Americano ou Nativo do Alasca/genética , Nicotina/uso terapêutico , Agonistas Nicotínicos/uso terapêutico , Estudos Retrospectivos , Fumar/tratamento farmacológico , Abandono do Hábito de Fumar/métodos , Dispositivos para o Abandono do Uso de TabacoRESUMO
Background: Little is known about vaccination rates for American Indian and Alaska Native (AI/AN) parents and their children, or parental decisions in this regard. Improving vaccination rates is a serious concern due to the disproportionate incidence and morbidity of COVID-19 in AI/AN people. Purpose: Our goal was to describe urban AI/AN parental attributes associated with COVID-19 vaccination of their children. Methods: Survey participants (n = 572) were ≥18 years of age, had children ≥5 years of age, AI/AN, and seen at one of six urban health organizations serving primarily AI/AN people within the prior year. They were asked about gender, age, education, marital status, perceived stress, trauma history, whether they had received the COVID-19 vaccine, tested positive for COVID-19 in the past, and if their child was vaccinated. They were also asked about 16 vaccine hesitancy reasons. Results: Parental vaccination rate was 82%, with 59% of their children vaccinated. Parents who vaccinated their children were older, had higher education, lower stress and trauma, and were more likely to be vaccinated compared to parents who did not vaccinate their children. Forty-two percent of parents indicated they would likely vaccinate their unvaccinated child in the future. Sixteen vaccine hesitancy reasons revealed four factors: distrust, inconvenience, lack of concern about the pandemic, and AI/AN concerns. Parents who had no plans to vaccinate their children had the highest vaccine distrust and lack of concern about the pandemic. Parents with greater vaccine distrust and AI/AN specific concern reported significantly greater trauma history and higher levels of education. Conclusion: Even though vaccination rates for AI/AN parents and children are high, the consequences of COVID-19 for AI/AN people are more severe than for other US populations. Providers should use trauma-informed, trust-building and culturally competent communication when discussing choices about vaccination with AI/AN parents.
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Newborn screening in Alaska includes screening for carnitine palmitoyltransferase 1A (CPT1A) deficiency. The CPT1A Arctic variant is a variant highly prevalent among Indigenous peoples in the Arctic. In this study, we sought to elicit Alaska Native (AN) community member and AN-serving healthcare providers' knowledge and perspectives on the CPT1A Arctic variant. Focus groups with community members and healthcare providers were held in two regions of Alaska between October 2018 and January 2019. Thematic analysis was used to identify recurring constructs. Knowledge and understanding about the CPT1A Arctic variant and its health impact varied, and participants were interested in learning more about it. Additional education for healthcare professionals was recommended to improve providers' ability to communicate with family caregivers about the Arctic variant. Engagement with AN community members identified opportunities to improve educational outreach via multiple modalities for providers and caregivers on the Arctic variant, which could help to increase culturally relevant guidance and avoid stigmatization, undue worry, and unnecessary intervention. Education and guidance on the care of infants and children homozygous for the CPT1A Arctic variant could improve care and reduce negative psychosocial effects.
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INTRODUCTION: Health care organizations of all types have adapted in response to COVID-19. Responding to the pandemic has varied across organizations and there are few standardized frameworks from which to evaluate an organizational response. This article reports COVID-19 responses by a tribal health care organization using a synthesized evaluation framework that integrated the organizational values and allowed for timely implementation of responses during this COVID-19 public health emergency. METHODS: The authors categorized each COVID-19 response into six domains, including leadership practices, patient engagement, operations management, teamwork and communication, public health, and external partnerships. Responses were analyzed by domain and across time. RESULTS: COVID-19 responses included medical alerts, modifying delivery of care, establishing testing and vaccination sites, additional benefits for employees, as well as new processes for communication between employees and senior leadership. COVID-19 responses were most frequently categorized into the operation management domain (80%). Many responses, especially those that considered patients, employees, and the community, also fit other domains. DISCUSSION: Operation management was the most frequent domain because the pandemic emerged rapidly and required swift, agile, action-oriented responses from the tribal health care organization. The majority of COVID-19 responses involved multiple, not single, domains. CONCLUSION: Our evaluation approach captured areas of importance to the tribal health organization and may be pertinent for other indigenous organizations and rural communities. It is especially important to consider tribal perspectives in response to COVID-19 because of the prior history with Western medicine and infectious diseases, and health care limitations experienced due to rurality.
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COVID-19 , Humanos , Comunicação , Liderança , Pandemias/prevenção & controle , Saúde PúblicaRESUMO
OBJECTIVES: Attitudes about alcohol misuse and dependence influence alcohol use and help-seeking behavior. Alaska Native and American Indian (AN/AI) people have higher rates of alcohol-related morbidity and mortality but engage in treatment at lower rates than the general population. No validated instruments exist to assess attitudes of AN/AI people about alcohol misuse and dependence to inform treatment and prevention efforts. This study aimed to develop an instrument to assess public attitudes among AN/AI people of alcohol misuse and dependence. METHODS: This multiphase, mixed-methods study was conducted at Southcentral Foundation, a tribally owned health system serving 65,000 AN/AI people in Alaska. We conducted focus groups and interviews with health system users, providers, and leaders to adapt the Public Attitudes About Addiction Survey. The adapted instrument was piloted with 200 people. Cognitive interviews and exploratory and confirmatory factor analyses were used to refine the instrument, which were then administered to 777 AN/AI people. RESULTS: Initial exploratory factor analysis identified 5 factors, including 3 from the original Public Attitudes About Addiction Survey (moral, disease, nature), a combined psychology and sociology factor (psychosocial), and a new factor (environment). A final 4-factor model (psychosocial, moral, disease, nature) with 14 items had good fit with root mean square error of approximation (0.035; comparative fit index = 0.977; Tucker-Lewis index = 0.970; standardized root mean residual = 0.040) and loadings ranging from 0.41 to 0.80. CONCLUSIONS: This study developed the first instrument to assess AN/AI attitudes about alcohol misuse and dependence. This instrument has potential to inform alcohol-related treatment in AN/AI communities. Future research is warranted to adequately measure place-based contributors salient to AN/AI people.
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Nativos do Alasca , Alcoolismo , Humanos , Alaska , Atenção à SaúdeRESUMO
Background: Food insecurity is an important social determinant of health that was exacerbated by the COVID-19 pandemic. Both food insecurity and COVID-19 infection disproportionately affect racial and ethnic minority groups, particularly American Indian and Alaska Native communities; however, there is little evidence as to whether food insecurity is associated with COVID-19 infection or COVID-19 preventive behaviors such as vaccination uptake. The purpose of this study was to evaluate associations between food insecurity, COVID-19 infection, and vaccination status among urban American Indian and Alaska Native adults seen at 5 clinics serving urban Native people. Methods: In partnership with health organizations in Alaska, Colorado, Kansas, Minnesota, and New Mexico, the study team conducted a cross-sectional survey in 2021 to assess food security status and attitudes, barriers, and facilitators for COVID-19 testing and vaccination. Logistic regression was used to examine the association of food security status with sociodemographic factors and COVID-19 infection and vaccination status. Marginal standardization was applied to present results as prevalence differences. Results: Among 730 American Indian and Alaska Native adults, the prevalence of food insecurity measured during the pandemic was 38%. For participants who reported persistent food security status before and during the pandemic (n=588), the prevalence of food insecurity was 25%. Prevalence of COVID-19 infection and vaccination did not vary by food security status after adjustment for confounders. Conclusions: High rates of food insecurity among American Indian and Alaska Native communities likely increased during the COVID-19 pandemic. However, despite the high prevalence of food insecurity, community-led efforts to reduce COVID-19 infection and increase vaccination uptake across Indian Health Service and Tribal healthcare facilities may have mitigated the negative impacts of the pandemic for families experiencing food insecurity. These successful approaches serve as an important reference for future public health efforts that require innovative strategies to improve overall health in AIAN communities.
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OBJECTIVES: To examine the relationships between pre-pregnancy diabetes mellitus (DM), gestational diabetes mellitus (GDM), pre-pregnancy body mass index (BMI) and county-level social determinants of health, with infant macrosomia within a sample of American Indian/Alaska Native (AI/AN) women receiving Indian Health Service (IHS) care. METHODS: The sample included women-infant dyads representing 1,136 singleton births from fiscal year 2011 (10/1/2019-9/30/2011). Data stemmed from the IHS Improving Health Care Delivery Data Project. Multivariate generalized linear mixed models were fitted to assess the association of macrosomia with pre-pregnancy health status and social determinants of health. RESULTS: Nearly half of the women in the sample were under age 25 years (48.6%), and most had Medicaid health insurance coverage (76.7%). Of those with a pre-pregnancy BMI measure, 66.2% were overweight or obese. Although few women had pre-pregnancy DM (4.0%), GDM was present in 12.8% of women. Most women had a normal term delivery (85.4%). Overweight, obesity, pre-pregnancy DM, and county-level rurality were all significantly associated with higher odds of infant macrosomia.
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Diabetes Gestacional , Gravidez , Lactente , Feminino , Humanos , Adulto , Macrossomia Fetal/epidemiologia , Sobrepeso , Indígena Americano ou Nativo do Alasca , Aumento de Peso , Diabetes Gestacional/epidemiologia , Peso ao Nascer , Índice de Massa Corporal , Obesidade , Nível de SaúdeRESUMO
Participant retention in longitudinal health research is necessary for generalizable results. Understanding factors that correlate with increased retention could improve retention in future studies. Here, we describe how participant and study process measures are associated with retention in a longitudinal tobacco cessation research study performed in Anchorage, Alaska. Specifically, we conducted a secondary analysis exploring retention among 151 Alaska Native and American Indian (ANAI) people and described our study processes using study retention categories from a recent meta-analysis. We found that our study processes influence retention among ANAI urban residents more than measures collected about the participant. For study process measures, calls where a participant answered and calls participants placed to the study team were associated with higher retention. Calls where the participant did not answer were associated with lower retention. For participant measures, only lower annual income was associated with lower retention at 6 weeks. Promoting communication from participants to the study team could improve retention, and alternative communication methods could be used after unsuccessful calls. Finally, categorizing our study retention strategies demonstrated that additional barrier-reduction strategies might be warranted.
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Indígenas Norte-Americanos , Abandono do Hábito de Fumar , Alaska , Humanos , Estudos Longitudinais , Abandono do Hábito de Fumar/métodosRESUMO
The prevalence of self-reported hypertension is higher among Alaska Native and American Indian (ANAI) individuals than in the majority USA population. Although hypertension is the primary modifiable risk factor for cardiovascular disease and stroke, it can be difficult to manage successfully. The objective of this study was to explore patients' and providers' perspectives about hypertension, hypertension management strategies, and patient-provider communication strategies within a tribally-owned and operated health system in Alaska. We conducted four focus groups that included 16 ANAI patients and five primary care providers. Patient participants tended to consider hypertension a transient state, in contrast with providers' understanding of hypertension as a chronic condition. Differences were noted in participants' perceptions regarding providers' counselling and education efforts, with providers feeling that current strategies are effective and patients desiring a more personalised discussion about hypertension. Patients expressed preferences for behaviour change approaches compared with pharmacotherapy; providers often resorted to medication as a first step towards controlling blood pressure. Our findings suggest areas of potentially promising future research with respect to patient-provider communication and treatment of hypertension.
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Hipertensão , Pressão Sanguínea , Humanos , Hipertensão/terapia , Atenção Primária à Saúde , Pesquisa QualitativaRESUMO
BACKGROUND: Home blood pressure monitoring (HBPM) is an effective tool in treatment and long-term management of hypertension. HBPM incorporates more data points to help patients and providers with diagnosis and management. The characteristics of HBPM devices matter to patients, but the relative importance of the characteristics in choosing a device remains unclear. METHODS: We used data from a randomized cross-over pilot study with 100 Alaska Native and American Indian (ANAI) people with hypertension to assess the choice of a wrist or arm HBPM device. We use a random utility framework to evaluate the relationship between stated likely use, perceived accuracy, ease of use, comfort, and participant characteristics with choice of device. Additional analyses examined willingness to change to a more accurate device. RESULTS: Participants ranked the wrist device higher compared to the arm on a 5-point Likert scale for likely use, ease of use, and comfort (0.3, 0.5, 0.8 percentage points, respectively). Most participants (66%) choose the wrist device. Likely use (wrist and arm devices) was related to the probability of choosing the wrist (0.7 and - 1.4 percentage points, respectively). Independent of characteristics, 75% of participants would be willing to use the more accurate device. Ease of use (wrist device) and comfort (arm device) were associated with the probability of changing to a more accurate device (- 1.1 and 0.5 percentage points, respectively). CONCLUSION: Usability, including comfort, ease, and likely use, appeared to discount the relative importance of perceived accuracy in the device choice. Our results contribute evidence that ANAI populations value accurate HBPM, but that the devices should also be easy to use and comfortable to facilitate long-term management.
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Algoritmos , Indígena Americano ou Nativo do Alasca , Monitorização Ambulatorial da Pressão Arterial/instrumentação , Pressão Sanguínea/fisiologia , Hipertensão/diagnóstico , Estudos Cross-Over , Feminino , Humanos , Hipertensão/etnologia , Hipertensão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Cooperação do Paciente , Projetos Piloto , Reprodutibilidade dos Testes , Estados Unidos/epidemiologiaRESUMO
Prevalence of smoking is higher in Alaska Native and American Indian (ANAI) populations living in Alaska than the general US population. Genetic factors contribute to smoking and cessation rates. The objective of this study was to compare CYP2A6 genetic variation and CYP2A6 enzyme activity toward nicotine in an ANAI population. ANAI (N = 151) people trying to quit smoking were recruited. DNA samples were genotyped for CYP2A6 variants *1X2A, *1B, *2, *4, *9, *10, *12, and *35. Multiple nicotine metabolites were measured in plasma and urine samples, including cotinine and 3'-hydroxycotinine used to determine CYP2A6 activity (e.g., nicotine metabolite ratio [NMR]). We calculated summary statistics for all of the genotypes and metabolites and assigned CYP2A6 activity scores based on known information. We studied the association of CYP2A6 variants with the NMR and smoking histories. The overall frequency of the CYP2A6*1B gain of function allele was high in the ANAI versus non-ANAI populations in other studies. Both *4 null and *9 decrease of function alleles had frequencies similar to previous studies of ANAI populations. In a multivariate analysis, the genotype-inferred CYP2A6 activity score was associated with both plasma and urine NMR (p value = 8.56E-08 and 4.08E-13, respectively). Plasma NMR was also associated with duration of smoking (p value < 0.01) but not urinary total nicotine equivalents uncorrected for creatinine (TNE9uc ) or biological sex. Urine NMR was significantly associated (p value < 0.01) with TNE9uc . Variation in NMR in this ANAI population is explained in part by CYP2A6 genetic variation.
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Citocromo P-450 CYP2A6 , Genótipo , Povos Indígenas , Nicotina/metabolismo , Adulto , Alaska , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Nicotina/sangue , Nicotina/urinaRESUMO
We provide guidance for conducting clinical trials with Indigenous children in the United States. We drew on extant literature and our experience to describe 3 best practices for the ethical and effective conduct of clinical trials with Indigenous children. Case examples of pediatric research conducted with American Indian, Alaska Native, and Native Hawaiian communities are provided to illustrate these practices. Ethical and effective clinical trials with Indigenous children require early and sustained community engagement, building capacity for Indigenous research, and supporting community oversight and ownership of research. Effective engagement requires equity, trust, shared interests, and mutual benefit among partners over time. Capacity building should prioritize developing Indigenous researchers. Supporting community oversight and ownership of research means that investigators should plan for data-sharing agreements, return or destruction of data, and multiple regulatory approvals. Indigenous children must be included in clinical trials to reduce health disparities and improve health outcomes in these pediatric populations. Establishment of the Environmental Influences on Child Health Outcomes Institutional Development Award States Pediatric Clinical Trials Network (ECHO ISPCTN) in 2016 creates a unique and timely opportunity to increase Indigenous children's participation in state-of-the-art clinical trials.
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/estatística & dados numéricos , Fortalecimento Institucional/organização & administração , Proteção da Criança/estatística & dados numéricos , Ensaios Clínicos como Assunto/normas , Indígenas Norte-Americanos/estatística & dados numéricos , Criança , Humanos , Projetos de Pesquisa , Segurança , Estados UnidosRESUMO
Objectives: Home blood pressure monitoring (HBPM) is an important component of blood pressure (BP) management. We assessed performance of two HBPM devices among Alaska Native and American Indian people (ANAIs). Methods: We measured BP using Omron BP786 arm cuff, Omron BP654 wrist cuff, and Baum aneroid sphygmomanometer in 100 ANAIs. Performance was assessed with intraclass correlation, paired t-tests, and calibration models. Results: Compared to sphygmomanometer, average BP was higher for wrist cuff (systolic = 4.8 mmHg and diastolic = 3.6 mmHg) and varied for arm cuff (systolic = -1.5 mmHg and diastolic = 2.5 mmHg). Calibration increased performance from grade B to A for arm cuff and from D to B for wrist cuff. Calibration increased false negatives and decreased false positives. Discussion: The arm HBPM device is more accurate than the wrist cuff among ANAIs with hypertension. Most patients are willing to use the arm cuff when accuracy is discussed.
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/estatística & dados numéricos , Indígena Americano ou Nativo do Alasca/estatística & dados numéricos , Determinação da Pressão Arterial/métodos , Monitorização Ambulatorial da Pressão Arterial/instrumentação , Pressão Sanguínea/fisiologia , Estudos Cross-Over , Feminino , Humanos , Hipertensão/diagnóstico , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos TestesRESUMO
Importance: Many American Indian and Alaska Native communities are disproportionately affected by problems with alcohol use and seek culturally appropriate and effective interventions for individuals with alcohol use disorders. Objective: To determine whether a culturally tailored contingency management intervention, in which incentives were offered for biologically verified alcohol abstinence, resulted in increased abstinence among American Indian and Alaska Native adults. This study hypothesized that adults assigned to receive a contingency management intervention would have higher levels of alcohol abstinence than those assigned to the control condition. Design, Setting, and Participants: This multisite randomized clinical trial, the Helping Our Native Ongoing Recovery (HONOR) study, included a 1-month observation period before randomization and a 3-month intervention period. The study was conducted at 3 American Indian and Alaska Native health care organizations located in Alaska, the Pacific Northwest, and the Northern Plains from October 10, 2014, to September 2, 2019. Recruitment occurred between October 10, 2014, and February 20, 2019. Eligible participants were American Indian or Alaska Native adults who had 1 or more days of high alcohol-use episodes within the last 30 days and a current diagnosis of alcohol dependence. Data were analyzed from February 1 to April 29, 2020. Interventions: Participants received treatment as usual and were randomized to either the contingency management group, in which individuals received 12 weeks of incentives for submitting a urine sample indicating alcohol abstinence, or the control group, in which individuals received 12 weeks of incentives for submitting a urine sample without the requirement of alcohol abstinence. Regression models fit with generalized estimating equations were used to assess differences in abstinence during the intervention period. Main Outcomes and Measures: Alcohol-negative ethyl glucuronide (EtG) urine test result (defined as EtG<150 ng/mL). Results: Among 1003 adults screened for eligibility, 400 individuals met the initial criteria. Of those, 158 individuals (39.5%; mean [SD] age, 42.1 [11.4] years; 83 men [52.5%]) met the criteria for randomization, which required submission of 4 or more urine samples and 1 alcohol-positive urine test result during the observation period before randomization. A total of 75 participants (47.5%) were randomized to the contingency management group, and 83 participants (52.5%) were randomized to the control group. At 16 weeks, the number who submitted an alcohol-negative urine sample was 19 (59.4%) in the intervention group vs 18 (38.3%) in the control group. Participants randomized to the contingency management group had a higher likelihood of submitting an alcohol-negative urine sample (averaged over time) compared with those randomized to the control group (odds ratio, 1.70; 95% CI, 1.05-2.76; P = .03). Conclusions and Relevance: The study's findings indicate that contingency management may be an effective strategy for increasing alcohol abstinence and a tool that can be used by American Indian and Alaska Native communities for the treatment of individuals with alcohol use disorders. Trial Registration: ClinicalTrials.gov Identifier: NCT02174315.
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Abstinência de Álcool , Alcoolismo/etnologia , Alcoolismo/terapia , Assistência à Saúde Culturalmente Competente/etnologia , Motivação , Adulto , Feminino , Glucuronatos/urina , Humanos , Colaboração Intersetorial , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Detecção do Abuso de Substâncias , Urinálise , Indígena Americano ou Nativo do Alasca/etnologiaRESUMO
The frequencies of genetic variants in the CYP3A4 and CYP3A5 genes differ greatly across global populations, leading to profound differences in the metabolic activity of these enzymes and resulting drug metabolism rates, with important consequences for therapeutic safety and efficacy. Yet, the impact of genetic variants on enzyme activity are incompletely described, particularly in American Indian and Alaska Native (AIAN) populations. To characterize genetic variation in CYP3A4 and CYP3A5 and its effect on enzyme activity, we partnered with AIAN people living in two regions of Alaska: Yup'ik Alaska Native people living in the Yukon-Kuskokwim Delta region of rural southwest Alaska and AIAN people receiving care at the Southcentral Foundation in Anchorage, Alaska. We identified low frequencies of novel and known variation in CYP3A4 and CYP3A5, including low frequencies of the CYP3A4*1G and CYP3A5*1 variants, and linkage disequilibrium patterns that differed from those we previously identified in an American Indian population in western Montana. We also identified increased activity of the CYP3A4*1G allele in vitro and in vivo. We demonstrated that the CYP3A4*1G allele confers increased protein content in human lymphoblastoid cells and both increased protein content and increased activity in human liver microsomes. We confirmed enhanced CYP3A4-mediated 4ß-vitamin D hydroxylation activity in Yup'ik people with the CYP3A4*1G allele. AIAN people in Alaska and Montana who carry the CYP3A4*1G allele-coupled with low frequency of the functional CYP3A5*1 variant-may metabolize CYP3A substrates more rapidly than people with the reference CYP3A4 allele.