Recovery from alcohol among urban Alaska Native and American Indian people.

Alaska Native and American Indian (ANAI) people experience dramatic alcohol-related health disparities compared to the general US population. Although the majority of ANAI people reside in urban settings (>70%), data are sparse on alcohol abstinence among urban ANAI people with alcohol use disorder (AUD). We conducted a qualitative study using a phenomenological approach to examine the experiences of 20 urban ANAI adults recovering from AUD. Participants' narratives had their own unique dimensions but shared a clear, interrelated trajectory of pre-alcohol recovery, a turning point, and ongoing alcohol recovery. All participants reported a combination of external and internal motivation to stop using alcohol.

Precision medicine research with American Indian and Alaska Native communities: Results of a deliberative engagement with tribal leaders.

PURPOSE: Amid calls for greater diversity in precision medicine research, the perspectives of Indigenous people have been underexplored. Our goals were to understand tribal leaders' views regarding the potential benefits and risks of such research, explore its priority for their communities, and identify the policies and safeguards they consider essential. This article reports on the participants' perspectives regarding governance and policy, stewardship and sharing of information and biospecimens, and informed consent. METHODS: After informal local dialogs with 21 tribal leaders, we convened a 2.5-day deliberation with tribal leaders (N = 10) in Anchorage, Alaska, in June 2019 using a combination of small group and plenary discussion, ranking, and voting exercises to explore the perspectives on precision medicine research. RESULTS: Tribal sovereignty was central to participants' ideas about precision medicine research. Although views were generally positive, provided that the appropriate controls were in place, some kinds of research were deemed unacceptable, and the collection of certain biospecimens was rejected by some participants. Differences were observed regarding the acceptability of broad consent. CONCLUSION: Tribal leaders in this study were generally supportive of precision medicine research, with the caveat that tribal oversight is essential for the establishment of research repositories and the conduct of research involving Indigenous participants.

Perceptions of alcohol misuse among Alaska native health care system stakeholders: A qualitative exploration.

Although alcohol misuse is a priority for health care systems serving Alaska Native and American Indian (ANAI) people, stakeholders' perceptions of misuse are understudied. Patients (n = 34), providers (n = 20), and leaders (n = 16) at a Tribally owned and operated health care system reported that alcohol misuse results from the interaction of factors, including colonization, structural factors, social alienation, social norms about overdrinking introduced at the time of colonizing contact, coping with emotions, and beliefs about ANAI people and alcohol. Childhood exposure to alcohol misuse leads some ANAI people to avoid alcohol altogether, shedding light on the high levels of abstinence observed in ANAI communities.

Lessons from PrEP: A Qualitative Study Investigating How Clinical and Policy Experts Weigh Ethics and Evidence When Evaluating Preventive Medications for Use in Pregnant and Breastfeeding Women.

This study explored how multinational HIV experts weigh clinical, evidential, and ethical considerations regarding pre-exposure prophylaxis in pregnant/breastfeeding women. Semi-structured interviews were conducted with experts in HIV policy, research, treatment, and implementation from three global regions. A constant comparative approach identified major themes. Experts noted that exclusion of pregnant women from research limits evidence regarding risks/benefits, emphasizing that underinclusion of pregnant women in RCTs shifts the onus of evidence-building to clinical care. Experts discussed approaches for weighing evidence to make decisions, including triangulating evidence from sources other than RCTs. Likelihood and severity of disease strongly influenced decisions. Less effective interventions with limited fetal risk were preferred over interventions of uncertain safety, unless the disease was serious. Experts resisted the dichotomous choice between protecting maternal and fetal interests, arguing that these interests are intertwined and that more holistic approaches to maternal-fetal balance support greater inclusion of pregnant women in research.

The role of male partners in women's participation in research during pregnancy: a case study from the partners demonstration project.

The exclusion of pregnant women from health research remains a significant challenge globally. In settings where cultural traditions and gender norms support a more restricted decision-making role for women in general, little is known about the attitudes of male partners toward the inclusion of women in research during pregnancy. Understanding the expectations of both men and women in such cultural settings offers an opportunity to engage and address local ethical concerns to improve women's access to research during pregnancy and enhance intervention development. In this paper, we present a qualitative research ethics case study, drawn from the Partners Demonstration Project of pre-exposure prophylaxis (PrEP) in Kenya, regarding the role of male partners in decision-making to continue PrEP during pregnancy. PrEP is an effective HIV prevention tool; however, since pregnant women were excluded from early PrEP clinical trials, safety and efficacy data during pregnancy are limited. Given continued high rates of HIV infection for women, some pregnant women are now being provided with PrEP or are involved in PrEP research. Men and women in our study were equally concerned about the health risks of PrEP to the fetus and depended on healthcare provider guidance to understand these risks. Because the demonstration project enrolled couples, an implicit social expectation for many women's continuation of PrEP during pregnancy was consultation with male partners. Some women reported that consenting to participate was exclusively a woman's decision; however, many reported that they deferred to their male partner's opinion and support during the decision-making process. Most male partners believed women should not participate in research studies without their partner's permission, while a few men believed participation was ultimately a woman's decision. We suggest that relational autonomy can support a middle ground for informed consent that promotes women's autonomy while accommodating partner engagement.

Community dissemination and genetic research: moving beyond results reporting.

The community-based participatory research (CBPR) literature notes that researchers should share study results with communities. In the case of human genetic research, results may be scientifically interesting but lack clinical relevance. The goals of this study were to learn what kinds of information community members want to receive about genetic research and how such information should be conveyed. We conducted eight focus group discussions with Yup'ik Alaska Native people in southwest Alaska (N = 60) and 6 (N = 61) with members of a large health maintenance organization in Seattle, Washington. Participants wanted to receive genetic information they "could do something about" and wanted clinically actionable information to be shared with their healthcare providers; they also wanted researchers to share knowledge about other topics of importance to the community. Although Alaska Native participants were generally less familiar with western scientific terms and less interested in web-based information sources, the main findings were the same in Alaska and Seattle: participants wished for ongoing dialogue, including opportunities for informal, small-group conversations, and receiving information that had local relevance. Effective community dissemination is more than a matter of presenting study results in lay language. Community members should be involved in both defining culturally appropriate communication strategies and in determining which information should be shared. Reframing dissemination as a two-way dialogue, rather than a one-way broadcast, supports the twin aims of advancing scientific knowledge and achieving community benefit.

Evaluating equity-promoting interventions to prevent race-based inequities in influenza outcomes.

Importance: Seasonal influenza hospitalizations pose a considerable burden in the United States, with BIPOC (Black, Indigenous, and other People of Color) communities being disproportionately affected. Objective: To determine and quantify the effects of different types of mitigation strategies on inequities in influenza outcomes (symptomatic infections and hospitalizations). Design: In this simulation study, we fit a race-stratified agent-based model of influenza transmission to demographic and hospitalization data of the United States. Participants: We consider five racial-ethnic groups: non-Hispanic White persons, non- Hispanic Black persons, non-Hispanic Asian persons, non-Hispanic American Indian or Alaska Native persons, and Hispanic or Latino persons. Setting: We tested five idealized equity-promoting interventions to determine their effectiveness in reducing inequity in influenza outcomes. The interventions assumed (i) equalized vaccination rates, (ii) equalized comorbidities, (iii) work-risk distribution proportional to the distribution of the population, (iv) reduced work contacts for all, or (v) a combination of equalizing vaccination rates and comorbidities and reducing work contacts. Main Outcomes and Measures: Reduction in symptomatic or hospitalization risk ratios, defined as the ratio of the number of symptomatic infections (hospitalizations respectively) in each age- and racial-ethnic group and their corresponding white counterpart. We also evaluated the reduction in the absolute mean number of symptomatic infections or hospitalizations in each age- and racial-ethnic group compared to the fitted scenario (baseline). Results: Our analysis suggests that symptomatic infections were equalized and reduced (by up to 17% in BIPOC adults aged 18-49) by strategies reducing work contacts or equalizing vaccination rates. Reducing comorbidities resulted in significant decreases in hospitalizations, with a reduction of over 40% in BIPOC groups. All tested interventions reduced the inequity in influenza hospitalizations in all racial-ethnic groups, but interventions reducing comorbidities in marginalized populations were the most effective. Notably, these interventions resulted in better outcomes across all racial-ethnic groups, not only those prioritized by the interventions. Conclusions and Relevance: In this simulation modeling study, equalizing vaccination rates and reducing number of work contacts (which are relatively simple strategies to implement) reduced the both the inequity in hospitalizations and the absolute number of symptomatic infections and hospitalizations in all age and racial-ethnic groups.

Ethics of Predicting and Preventing Preterm Birth.

Preterm birth (PTB) occurs disproportionately among women who are minoritized and who live and work in poverty. This disadvantage occurs as a result of societal norms and policies that affect how people are treated and determine their access to a broad range of resources. Research that takes social context into account offers the best opportunity for identifying approaches to prevent PTB. The experience and knowledge of women from groups experiencing high rates of PTB can provide important insights for research design and for determining the feasibility and acceptability of potential interventions.

Return of incidental findings in genomic medicine: measuring what patients value--development of an instrument to measure preferences for information from next-generation testing (IMPRINT).

PURPOSE: Little is known about the factors that influence patients' preferences for the return of incidental findings from genome sequencing. This study identified attributes of incidental findings that were important to patients and developed a discrete-choice experiment instrument to quantify patient preferences. METHODS: An initial set of key attributes and attribute levels was developed from a literature review and in consultation with experts. The attributes' salience and communication were refined using focus group methodology (n = 12) and cognitive interviews (n = 6) with patients who had received conventional genetic testing for familial colorectal cancer or polyposis syndromes. The attributes and levels used in the hypothetical choices presented to participants were identified using validated experimental design techniques. RESULTS: The final discrete-choice experiment instrument incorporates the following attributes and levels: lifetime risk of disease (5, 40, 70%); disease treatability (medical, lifestyle, none); disease severity (mild, moderate, severe); carrier status (yes, no); drug response likelihood (high, moderate, none); and test cost ($250, $425, $1,000, $1,900). CONCLUSION: Patient preferences for incidental genomic findings are likely influenced by a complex set of diverse attributes. Quantification of patient preferences can inform patient-provider communication by highlighting the attributes of incidental findings that matter most to patients and warrant further discussion.

Stakeholder engagement: a key component of integrating genomic information into electronic health records.

Integrating genomic information into clinical care and the electronic health record can facilitate personalized medicine through genetically guided clinical decision support. Stakeholder involvement is critical to the success of these implementation efforts. Prior work on implementation of clinical information systems provides broad guidance to inform effective engagement strategies. We add to this evidence-based recommendations that are specific to issues at the intersection of genomics and the electronic health record. We describe stakeholder engagement strategies employed by the Electronic Medical Records and Genomics Network, a national consortium of US research institutions funded by the National Human Genome Research Institute to develop, disseminate, and apply approaches that combine genomic and electronic health record data. Through select examples drawn from sites of the Electronic Medical Records and Genomics Network, we illustrate a continuum of engagement strategies to inform genomic integration into commercial and homegrown electronic health records across a range of health-care settings. We frame engagement as activities to consult, involve, and partner with key stakeholder groups throughout specific phases of health information technology implementation. Our aim is to provide insights into engagement strategies to guide genomic integration based on our unique network experiences and lessons learned within the broader context of implementation research in biomedical informatics. On the basis of our collective experience, we describe key stakeholder practices, challenges, and considerations for successful genomic integration to support personalized medicine.

Seeking Genomic Knowledge: The Case for Clinical Restraint.

Genome sequencing technology provides new and promising tests for clinical practice, including whole genome sequencing, which measures an individual's complete DNA sequence, and whole exome sequencing, which measures the DNA for all genes coding for proteins. These technologies make it possible to test for multiple genes in a single test, which increases the efficiency of genetic testing. However, they can also produce large amounts of information that cannot be interpreted or is of limited clinical utility. This additional information could be distracting for patients and clinicians, and contribute to unnecessary healthcare costs. The potential for genomic sequencing to improve care will be context-dependent, varying for different patients and clinical settings. This Article argues that a disciplined approach is needed, incorporating research to assess when and how genomic information can improve clinical outcomes, practice guidelines that direct optimal uses of genomic sequencing, and efforts to limit the production of genomic information unrelated to the clinical needs of the patient. Without this approach, genomic testing could add to current unsustainable healthcare costs and prove unaffordable in the long run.

Human-to-Computer Interactivity Features Incorporated Into Behavioral Health mHealth Apps: Systematic Search.

BACKGROUND: While there are thousands of behavioral health apps available to consumers, users often quickly discontinue their use, which limits their therapeutic value. By varying the types and number of ways that users can interact with behavioral health mobile health apps, developers may be able to support greater therapeutic engagement and increase app stickiness. OBJECTIVE: The main objective of this analysis was to systematically characterize the types of user interactions that are available in behavioral health apps and then examine if greater interactivity was associated with greater user satisfaction, as measured by app metrics. METHODS: Using a modified PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) methodology, we searched several different app clearinghouse websites and identified 76 behavioral health apps that included some type of interactivity. We then filtered the results to ensure we were examining behavioral health apps and further refined our search to include apps that identified one or more of the following terms: peer or therapist forum, discussion, feedback, professional, licensed, buddy, friend, artificial intelligence, chatbot, counselor, therapist, provider, mentor, bot, coach, message, comment, chat room, community, games, care team, connect, share, and support in the app descriptions. In the final group of 34 apps, we examined the presence of 6 types of human-machine interactivities: human-to-human with peers, human-to-human with providers, human-to-artificial intelligence, human-to-algorithms, human-to-data, and novel interactive smartphone modalities. We also downloaded information on app user ratings and visibility, as well as reviewed other key app features. RESULTS: We found that on average, the 34 apps reviewed included 2.53 (SD 1.05; range 1-5) features of interactivity. The most common types of interactivities were human-to-data (n=34, 100%), followed by human-to-algorithm (n=15, 44.2%). The least common type of interactivity was human-artificial intelligence (n=7, 20.5%). There were no significant associations between the total number of app interactivity features and user ratings or app visibility. We found that a full range of therapeutic interactivity features were not used in behavioral health apps. CONCLUSIONS: Ideally, app developers would do well to include more interactivity features in behavioral health apps in order to fully use the capabilities of smartphone technologies and increase app stickiness. Theoretically, increased user engagement would occur by using multiple types of user interactivity, thereby maximizing the benefits that a person would receive when using a mobile health app.

The Cultural Adaption of a Sobriety Support App for Alaska Native and American Indian People: Qualitative Feasibility and Acceptability Study.

BACKGROUND: Despite high rates of alcohol abstinence, Alaska Native and American Indian (ANAI) people experience a disproportionate burden of alcohol-related morbidity and mortality. Multiple barriers to treatment exist for this population, including a lack of culturally relevant resources; limited access to or delays in receiving treatment; and privacy concerns. Many ANAI people in the state of Alaska, United States, live in sparsely populated rural areas, where treatment access and privacy concerns regarding peer-support programs may be particularly challenging. In addition, prior research demonstrates that many ANAI people prefer a self-management approach to sobriety, rather than formal treatment. Taken together, these factors suggest a potential role for a culturally adapted smartphone app to support ANAI people interested in changing their behavior regarding alcohol use. OBJECTIVE: This study was the first phase of a feasibility and acceptability study of a culturally tailored version of an off-the-shelf smartphone app to aid ANAI people in managing or reducing their use of alcohol. The aim of this qualitative needs assessment was to gather insights and preferences from ANAI people and health care providers serving ANAI people to guide feature development, content selection, and cultural adaptation before a pilot test of the smartphone app with ANAI people. METHODS: From October 2018 to September 2019, we conducted semistructured interviews with 24 ANAI patients aged ≥21 years and 8 providers in a tribal health care organization in south-central Alaska. RESULTS: Participants generally endorsed the usefulness of a smartphone app for alcohol self-management. They cited anonymity, 24/7 access, peer support, and patient choice as key attributes of an app. The desired cultural adaptations included ANAI- and land-themed design elements, cultural content (eg, stories from elders), and spiritual resources. Participants considered an app especially useful for rural-dwelling ANAI people, as well as those who lack timely access to treatment services or prefer to work toward managing their alcohol use outside the clinical setting. CONCLUSIONS: This needs assessment identified key features, content, and cultural adaptations that are being implemented in the next phase of the study. In future work, we will determine the extent to which these changes can be accommodated in a commercially available app, the feasibility of implementation, and the acceptability of the culturally adapted version of the app among ANAI users.

The CPT1A Arctic variant: perspectives of community members and providers in two Alaska tribal health settings.

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.

Patient and primary care perspectives on hypertension management: short report of a qualitative study in a tribal health system.

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.

Tribal Deliberations about Precision Medicine Research: Addressing Diversity and Inequity in Democratic Deliberation Design and Evaluation.

Deliberative democratic engagement is used around the globe to gather informed public input on contentious collective questions. Yet, rarely has it been used to convene individuals exclusively from Indigenous communities. The relative novelty of using this approach to engage tribal communities and concerns about diversity and inequities raise important methodological questions. We describe the design and quality outcomes for a 2.5-day deliberation that elicited views of American Indian and Alaska Native (AIAN) leaders about the potential value and ethical conduct of precision medicine research (PMR), an emerging approach to research that investigates the health effects of individual genetic variation in tandem with variation in health-relevant practices, social determinants, and environmental exposures. The event met key goals, such as relationship and rapport formation, cross-site learning, equality of opportunity to participate, and respect among participants in the context of disagreement.

Patient-centered discussions about prostate cancer screening: a real-world approach.

National guidelines recommend that primary care providers discuss the risks and benefits of prostate cancer screening with their patients but give little guidance on how to fit such a complex discussion into a busy clinic encounter. The authors propose a process-oriented approach (Ask-Tell-Ask) that promotes tailored conversations and value-based recommendations. The Ask-Tell-Ask approach includes diagnosing a patient's informational needs, providing targeted education based on those needs, and making a shared decision about testing. This time-efficient model emphasizes the provider's role as an interactive guide rather than a one-way supplier of information. Although there is no way to make these discussions simple, this streamlined strategy can help patients and providers efficiently negotiate the complex and important decision of screening for prostate cancer.

Genomic research and wide data sharing: views of prospective participants.

PURPOSE: Sharing study data within the research community generates tension between two important goods: promoting scientific goals and protecting the privacy interests of study participants. This study was designed to explore the perceptions, beliefs, and attitudes of research participants and possible future participants regarding genome-wide association studies and repository-based research. METHODS: Focus group sessions with (1) current research participants, (2) surrogate decision-makers, and (3) three age-defined cohorts (18-34 years, 35-50, >50). RESULTS: Participants expressed a variety of opinions about the acceptability of wide sharing of genetic and phenotypic information for research purposes through large, publicly accessible data repositories. Most believed that making de-identified study data available to the research community is a social good that should be pursued. Privacy and confidentiality concerns were common, although they would not necessarily preclude participation. Many participants voiced reservations about sharing data with for-profit organizations. CONCLUSIONS: Trust is central in participants' views regarding data sharing. Further research is needed to develop governance models that enact the values of stewardship.

"You Actually View Us as the Experts in Our Own System": Indigenous-Academic Community Partnership.

BACKGROUND: The literature on community-engaged research provides important principles to guide research partnerships, but concrete descriptions of the complexities involved in developing, navigating, and maintaining such partnerships are lacking. OBJECTIVES: To describe and assess a longstanding, complex research partnership between Indigenous and academic pharmacogenetic research partners, with attention to co-learning and capacity building lessons learned. METHODS: Descriptive thematic analysis of 11 semistructured interviews with interdisciplinary research partners situated at Indigenous and academic settings. RESULTS: Lessons learned included the need for explicit negotiation around mentoring expectations, and discussion on advisory and staff roles. Partners need to be aware not only of the structures, policies, and hierarchies within each partner institution, but also the tacit value commitments and understandings entailed in their different missions. CONCLUSIONS: This study highlights that the concept of "bidirectional" learning as it is usually presented in the literature fails to capture the complexity of how partnerships work.