Alaska Native Participants Research Articles

Clinical Trial Racial and Ethnic Disparities in Minimally Invasive Gynecologic Surgery

Study ObjectiveTo study racial and ethnicity disparities in randomized clinical trials (RCT) in Minimally Invasive Gynecologic Surgery (MIGS). DesignCross sectional study. SettingOnline review of all published MIGS RCTs in high-impact journals from 2012 to 2023. PatientsJournals included all Q1 Obstetrics & Gynecology journals, as well as The New England Journal of Medicine, The Lancet, The British Medical Journal, and The Journal of the American Medical Association. The National Institutes of Health's PubMed and the ClinicalTrials.gov websites were queried using the following search terms from the American Board of Obstetrics and Gynecology's certifying examination bulletin 2022 to obtain relevant trials: adenomyosis, adnexal surgery, abnormal uterine bleeding, cystectomy, endometriosis, fibroids, gynecology, hysterectomy, hysteroscopy, laparoscopy, leiomyoma, minimally invasive gynecology, myomectomy, ovarian cyst, robotic surgery InterventionsThe United States (US) Census Bureau data was used to estimate the expected number of participants. We calculated the enrollment ratio (ER) of actual to expected participants for US trials with race and ethnicity data available. Measurements and Main ResultsA total of 352 RCTs were identified. Of these, race and/or ethnicity data were available in 65 studies (18.5%). We analyzed the 46 studies that originated in the US, with a total of 4,645 participants. Of these RCTs only 8 (17.4%) reported ethnicity in addition to race. When comparing published RCT data to expected proportions of participants, White participants were overrepresented [70.8% versus 59.6%, ER 1.66, 95% confidence interval (CI) 1.52-1.81], as well as Black or African American participants (15.4% versus 13.7%, ER 1.15, 95% CI 1.03-1.29). Hispanic (6.7% versus 19.0%, ER 0.31, 95% CI 0.27-0.35), Asian (1.7% versus 6.1%, ER 0.26, 95% CI 0.20-0.34), Native Hawaiian or Other Pacific Islander (0.1% versus 0.3%, ER 0.21, 95% CI 0.06-0.74), and Indian or Alaska Native participants (0.2% versus 1.3%, ER 0.16, 95% CI 0.08-0.32) were underrepresented. When comparing race/ethnicity proportions to the 20 states where the RCTs were conducted, Black or African American participants were underrepresented. ConclusionIn MIGS RCTs conducted in the US, White and Black or African American participants are overrepresented compared to other races, and ethnicity is characterized in fewer than one fifth of trials. Efforts should be made to improve racial and ethnic recruitment equity as well as reporting in future MIGS RCTs.

Retention of American Indian and Alaska Native participants in the National Alzheimer's Coordinating Center Uniform Data Set.

The number of American Indian and Alaska Native (AI/AN) elders is expected to double by 2060. Thus it is imperative to retain AI/AN participants in longitudinal research studies to identify novel risk factors and potential targets for intervention for Alzheimer's disease and related dementias in these communities. The National Alzheimer's Coordinating Center houses uniformly collected longitudinal data from the network of National Institute on Aging (NIA)-funded Alzheimer's Disease Research Centers (ADRCs). We used logistic regression to quantify participant retention at 43 ADRCs, comparing self-identified AI/AN participants to non-Hispanic White (NHW) participants, adjusting for potential confounding factors including baseline diagnosis, age, sex, education, and smoking. The odds of AI/AN participant retention at the first follow-up visit were significantly lower than those for NHW participants (adjusted odds ratio [aOR]: 0.599; 95%: 0.46-0.78; p<0.001). These results suggest the need for improved strategies to retain AI/AN participants, perhaps including improved researcher-community relationships and community engagement and education. American Indian and Alaska Native (AI/AN) research participants were retained to the first follow-up appointment at lower rates than non-Hispanic White (NHW) participants. AI/AN participants are retained at lower rates than NHW participants for long-term follow-up. The majority of AI/AN participants were not retained to the second follow-up visit.

Intra‐ and post‐procedural lumbar puncture symptoms in a sample of Black/African American, American Indian/Alaska Native, and White middle age older adults

AbstractBackgroundCerebral spinal fluid (CSF) as a biomarker of Alzheimer’s disease (AD) is a helpful tool in diagnosing preclinical disease. While blood‐based biomarkers are becoming increasingly used for early detection, CSF collection is still necessary for validation of AD blood‐based biomarkers and for identification of biomarkers for other types of dementias, including those that commonly co‐occur with AD. Attitudes and beliefs surrounding lumbar punctures (LPs) vary, and differing techniques as well as side effect rates might dissuade both clinicians and participants from considering LPs as a viable biomarker option. The aim of this analysis was to examine intra‐ and post‐procedural symptoms of a specific technique for collecting CSF from adult volunteers enrolled in the Wisconsin Alzheimer’s Disease Research Center.MethodLPs were performed on 587 volunteers using a standardized LP technique with atraumatic needle. Up to 22 milliliters of cerebral spinal fluid was obtained using gentle syringe aspiration of fluid. Clinician notes documenting the procedure were used to assess intra‐procedural symptoms. A follow‐up phone call the next day was used to evaluate any post‐procedural symptoms. The association between participant characteristics and LP intra‐procedural symptoms, post‐procedural symptoms, and LP success were tested using linear regression.ResultThe majority of participants did not report any intra‐procedural (59%) or post‐procedural (77%) symptoms. Being female was associated with experiencing increased intra‐procedural symptoms among Black / African American and White participants; younger age and lower waist‐to‐hip ratio were associated with higher rates of intra‐procedural symptoms among White participants. Participant characteristics were not associated with post‐procedural symptoms. LP success was high for all groups (67% to 90%). Among White participants, pain and vasovagal responses were associated with terminating the LP before sufficient fluid was collected. Among Black / African American participants, pain was associated with terminating the LP procedure before sufficient fluid was collected. Among American Indian / Alaska Native participants, no intra‐procedural symptoms were associated with early LP termination.ConclusionWe provide rates of LP intra‐procedural and post‐procedural symptoms in a diverse sample of middle‐aged and older adults. These data suggest that LPs are safe and well tolerated across a diverse group of participants.

Cancer Screening Prevalence among Participants in the Southcentral Alaska Education and Research towards Health (EARTH) Study at Baseline and Follow-Up.

Alaska Native communities are working to prevent cancer through increased cancer screening and early detection. We examined the prevalence of self-reported colorectal (CRC), cervical, and breast cancer screening among Alaska Native participants in the southcentral Alaska Education and Research toward Health (EARTH) study at baseline (2004-2006) and ten-year follow-up (2015-2017); participant characteristics associated with screening; and changes in screening prevalence over time. A total of 385 participants completed questionnaires at follow-up; 72% were women. Of those eligible for CRC screening, 53% of follow-up participants reported a CRC screening test within the past 5 years, significantly less than at baseline (70%) (p = 0.02). There was also a significant decline in cervical cancer screening between baseline and follow-up: 73% of women at follow-up vs. 90% at baseline reported screening within the past three years (p < 0.01). There was no significant difference in reported breast cancer screening between baseline (78%) and follow-up (77%). Colorectal and cervical cancer screening prevalence in an urban, southcentral Alaska Native cohort declined over 10 years of follow-up. Increased cancer screening and prevention are needed to decrease Alaska Native cancer-related morbidity and mortality.

Clinical and Demographic Factors Associated With COVID-19, Severe COVID-19, and SARS-CoV-2 Infection in Adults

Current data identifying COVID-19 risk factors lack standardized outcomes and insufficiently control for confounders. To identify risk factors associated with COVID-19, severe COVID-19, and SARS-CoV-2 infection. This secondary cross-protocol analysis included 4 multicenter, international, randomized, blinded, placebo-controlled, COVID-19 vaccine efficacy trials with harmonized protocols established by the COVID-19 Prevention Network. Individual-level data from participants randomized to receive placebo within each trial were combined and analyzed. Enrollment began July 2020 and the last data cutoff was in July 2021. Participants included adults in stable health, at risk for SARS-CoV-2, and assigned to the placebo group within each vaccine trial. Data were analyzed from April 2022 to February 2023. Comorbid conditions, demographic factors, and SARS-CoV-2 exposure risk at the time of enrollment. Coprimary outcomes were COVID-19 and severe COVID-19. Multivariate Cox proportional regression models estimated adjusted hazard ratios (aHRs) and 95% CIs for baseline covariates, accounting for trial, region, and calendar time. Secondary outcomes included severe COVID-19 among people with COVID-19, subclinical SARS-CoV-2 infection, and SARS-CoV-2 infection. A total of 57 692 participants (median [range] age, 51 [18-95] years; 11 720 participants [20.3%] aged ≥65 years; 31 058 participants [53.8%] assigned male at birth) were included. The analysis population included 3270 American Indian or Alaska Native participants (5.7%), 7849 Black or African American participants (13.6%), 17 678 Hispanic or Latino participants (30.6%), and 40 745 White participants (70.6%). Annualized incidence was 13.9% (95% CI, 13.3%-14.4%) for COVID-19 and 2.0% (95% CI, 1.8%-2.2%) for severe COVID-19. Factors associated with increased rates of COVID-19 included workplace exposure (high vs low: aHR, 1.35 [95% CI, 1.16-1.58]; medium vs low: aHR, 1.41 [95% CI, 1.21-1.65]; P < .001) and living condition risk (very high vs low risk: aHR, 1.41 [95% CI, 1.21-1.66]; medium vs low risk: aHR, 1.19 [95% CI, 1.08-1.32]; P < .001). Factors associated with decreased rates of COVID-19 included previous SARS-CoV-2 infection (aHR, 0.13 [95% CI, 0.09-0.19]; P < .001), age 65 years or older (aHR vs age <65 years, 0.57 [95% CI, 0.50-0.64]; P < .001) and Black or African American race (aHR vs White race, 0.78 [95% CI, 0.67-0.91]; P = .002). Factors associated with increased rates of severe COVID-19 included race (American Indian or Alaska Native vs White: aHR, 2.61 [95% CI, 1.85-3.69]; multiracial vs White: aHR, 2.19 [95% CI, 1.50-3.20]; P < .001), diabetes (aHR, 1.54 [95% CI, 1.14-2.08]; P = .005) and at least 2 comorbidities (aHR vs none, 1.39 [95% CI, 1.09-1.76]; P = .008). In analyses restricted to participants who contracted COVID-19, increased severe COVID-19 rates were associated with age 65 years or older (aHR vs <65 years, 1.75 [95% CI, 1.32-2.31]; P < .001), race (American Indian or Alaska Native vs White: aHR, 1.98 [95% CI, 1.38-2.83]; Black or African American vs White: aHR, 1.49 [95% CI, 1.03-2.14]; multiracial: aHR, 1.81 [95% CI, 1.21-2.69]; overall P = .001), body mass index (aHR per 1-unit increase, 1.03 [95% CI, 1.01-1.04]; P = .001), and diabetes (aHR, 1.85 [95% CI, 1.37-2.49]; P < .001). Previous SARS-CoV-2 infection was associated with decreased severe COVID-19 rates (aHR, 0.04 [95% CI, 0.01-0.14]; P < .001). In this secondary cross-protocol analysis of 4 randomized clinical trials, exposure and demographic factors had the strongest associations with outcomes; results could inform mitigation strategies for SARS-CoV-2 and viruses with comparable epidemiological characteristics.

Incarceration of Youths in an Adult Correctional Facility and Risk of Premature Death

ImportanceYouths incarcerated in adult correctional facilities are exposed to a variety of adverse circumstances that could diminish psychological and physical health, potentially leading to early mortality.ObjectiveTo evaluate whether being incarcerated in an adult correctional facility as a youth was associated with mortality between 18 and 39 years of age.Design, Setting, and ParticipantsThis cohort study relied on longitudinal data collected from 1997 to 2019 as part of the National Longitudinal Survey of Youth–1997, a nationally representative sample of 8984 individuals born in the United States between January 1, 1980, and December 1, 1984. The data analyzed for the current study were derived from annual interviews between 1997 and 2011 and interviews every other year from 2013 to 2019 (19 interviews in total). Participants were limited to respondents aged 17 years or younger during the 1997 interview and alive during their 18th birthday (8951 individuals; &amp;amp;gt;99% of the original sample). Statistical analysis was performed from November 2022 to May 2023.InterventionIncarceration in an adult correctional facility before the age of 18 years compared with being arrested before the age of 18 years or never arrested or incarcerated before the age of 18 years.Main Outcomes and MeasuresThe main outcome for the study was age at mortality between 18 and 39 years of age.ResultsThe sample of 8951 individuals included 4582 male participants (51%), 61 American Indian or Alaska Native participants (1%), 157 Asian participants (2%), 2438 Black participants (27%), 1895 Hispanic participants (21%), 1065 participants of other race (12%), and 5233 White participants (59%). A total of 225 participants (3%) died during the study period, with a mean (SD) age at death of 27.7 (5.9) years. Incarceration in an adult correctional facility before the age of 18 years was associated with an increased risk of earlier mortality between 18 and 39 years of age compared with individuals who were never arrested or incarcerated before the age of 18 years (time ratio, 0.67; 95% CI, 0.47-0.95). Being arrested before the age of 18 years was associated with an increased risk of earlier mortality between 18 and 39 years of age when compared with individuals who were never arrested or incarcerated before the age of 18 years (time ratio, 0.82; 95% CI, 0.73-0.93).Conclusions and RelevanceIn this cohort study of 8951 youths, the survival model suggested that being incarcerated in an adult correctional facility may be associated with an increased risk of early mortality between 18 and 39 years of age.

Lessons learned and future directions: A scoping review of American Indian and Alaska Native participants in the National Drug Abuse Treatment Clinical Trials Network

IntroductionAmerican Indian and Alaska Native (AI/AN) populations are disproportionately affected by substance use disorders (SUDs) and related health disparities in contrast to other ethnoracial groups in the United States. Over the past 20 years, substantial resources have been allocated to the National Institute on Drug Abuse Clinical Trials Network (CTN) to disseminate and implement effective SUD treatments in communities. However, we know little about how these resources have benefitted AI/AN peoples with SUD who arguably experience the greatest burden of SUDs. This review aims to determine lessons learned about AI/AN substance use and treatment outcomes in the CTN and the role of racism and Tribal identity. MethodWe conducted a scoping review informed by the Joanna Briggs framework and PRISMA Extension for Scoping Reviews checklist and explanation. The study team conducted the search strategy within the CTN Dissemination Library and nine additional databases for articles published between 2000 and 2021. The review included studies if they reported results for AI/AN participants. Two reviewers determined study eligibility. ResultsA systematic search yielded 13 empirical articles and six conceptual articles. Themes from the 13 empirical articles included: (1) Tribal Identity: Race, Culture, and Discrimination; (2) Treatment Engagement: Access and Retention; (3) Comorbid Conditions; (4) HIV/Risky Sexual Behaviors; and (5) Dissemination. The most salient theme was Tribal Identity: Race, Culture, and Discrimination, which was present in all articles that included a primary AI/AN sample (k = 8). Themes assessed but not identified for AI/AN peoples were Harm Reduction, Measurement Equivalence, Pharmacotherapy, and Substance Use Outcomes. The conceptual contributions used AI/AN CTN studies as exemplars of community-based and Tribal participatory research (CBPR/TPR). ConclusionCTN studies conducted with AI/AN communities demonstrate culturally congruent methods, including CBPR/TPR strategies; consideration/assessment of cultural identity, racism, and discrimination; and CBPR/TPR informed dissemination plans. Although important efforts are underway to increase AI/AN participation in the CTN, future research would benefit from strategies to increase participation of this population. Such strategies include reporting AI/AN subgroup data; addressing issues of cultural identity and experiences of racism; and adopting an overall effort for research aimed at understanding barriers to treatment access, engagement, utilization, retention, and outcomes for both treatment and research disparities for AI/AN populations.

Hesitant adopters: COVID-19 vaccine hesitancy among diverse vaccinated adults in the United States

BackgroundDespite the United States (US) having an abundant supply of COVID-19 vaccines, vaccination rates lag behind other high-income countries, suggesting that vaccine hesitancy and attitudes play a greater role in public health measures than pure supply and access. With the acknowledgment that vaccination attitudes and status may or may not be correlated, this study examined COVID-19 vaccine hesitancy among vaccinated US adults by asking: 1) What is the prevalence of COVID-19 vaccine hesitancy among the vaccinated? 2) Does COVID-19 vaccine hesitancy vary across sociodemographic characteristics? 3) Does COVID-19 vaccine hesitancy vary by healthcare access and influenza vaccination over the past 5 years? MethodsData were collected through an online survey of 2022 US adults with a final analytic sample of 1383 vaccinated respondents. ResultsOverall, 48.8% of vaccinated adults reported some level of hesitancy, while a slight majority reported they were “not at all hesitant”. Younger respondents, women, and Black and American Indian or Alaska Native participants had greater adjusted odds of being more hesitant towards receiving the COVID-19 vaccine. Respondents who had a primary care physician had greater adjusted odds than those who did not have a primary care physician of being more hesitant towards receiving the COVID-19 vaccine. ConclusionsThis is the first population-based national sample study examining COVID-19 vaccine hesitancy among vaccinated individuals from subgroups of distinctive backgrounds in order to inform targeted strategies for reducing vaccine hesitancy. Findings can assist in efforts to increase vaccination rates and also decrease vaccine hesitancy at the national level.

Sex, Racial, and Ethnic Representation in COVID-19 Clinical Trials

Since the onset of the COVID-19 pandemic, there have been calls for COVID-19 clinical trials to be fully representative of all demographic groups. However, limited evidence is available about the sex, racial, and ethnic representation among COVID-19 prevention and treatment trials. To investigate whether female participants and racial and ethnic minority individuals are adequately represented in COVID-19 prevention and treatment trials in the US. Identified studies were registered on ClinicalTrials.gov or published in the PubMed database from October 2019 to February 2022. Included studies must have provided the number of enrolled participants by sex, race, or ethnicity. Only interventional studies conducted in the US for the primary purpose of the diagnosis, prevention, or treatment of (or supportive care for) COVID-19 conditions were included. Data on counts of enrollments by demographic variables (sex, race, and ethnicity) and location (country and state) were abstracted. Studies were broadly categorized by primary purpose as prevention (including vaccine and diagnosis studies) vs treatment (including supportive care studies). A random effects model for single proportions was used. Trial estimates were compared with corresponding estimates of representation in the US population with COVID-19. Sex, racial, and ethnic representation in COVID-19 clinical trials compared with their representation in the US population with COVID-19. Overall, 122 US-based COVID-19 clinical trials comprising 176 654 participants were analyzed. Studies were predominantly randomized trials (n = 95) for treatment of COVID-19 (n = 103). Sex, race, and ethnicity were reported in 109 (89.3%), 95 (77.9%), and 87 (71.3%) trials, respectively. Estimated representation in prevention and treatment trials vs the US population with COVID-19 was 48.9% and 44.6% vs 52.4% for female participants; 23.0% and 36.6% vs 17.7% for Hispanic or Latino participants; 7.2% and 16.5% vs 14.1% for Black participants; 3.8% and 4.6% vs 3.7% for Asian participants; 0.2% and 0.9% vs 0.2% for Native Hawaiian or Other Pacific Islander participants; and 1.3% and 1.4% vs 1.1% for American Indian or Alaska Native participants. Compared with expected rates in the COVID-19 reference population, female participants were underrepresented in treatment trials (85.1% of expected; P < .001), Black participants (53.7% of expected; P = .003) and Asian participants (64.4% of expected; P = .003) were underrepresented in prevention trials, and Hispanic or Latino participants were overrepresented in treatment trials (206.8% of expected; P < .001). In this systematic review and meta-analysis, aggregate differences in representation for several demographic groups in COVID-19 prevention and treatment trials in the US were found. Strategies to better ensure diverse representation in COVID-19 studies are needed, especially for prevention trials.

Participation of Patients From Racial and Ethnic Minority Groups in Phase 1 Early Cancer Drug Development Trials in the US, 2000-2018

Despite federal initiatives encouraging the enrollment of individuals from racial and ethnic minority groups in US clinical trials, no studies to date have specifically examined demographic disparities among participants in phase 1 drug development trials for patients with metastatic cancer. To assess trends in the enrollment of patients from racial and ethnic minority groups in US phase 1 therapeutic drug trials for metastatic cancer from 2000 to 2018. In this cross-sectional study, ClinicalTrials.gov was queried in July 2021 to identify completed phase 1 drug trials for metastatic cancer in the US from January 1, 2000, to December 31, 2018, with published results, yielding 221 phase 1 trials with 8309 participants aged 18 years or older with metastatic solid tumors. Proportions of each racial and ethnic group of trial participants were compared with that from the North American Association of Central Cancer Registries' Cancer in North America (CiNA) database. Statistical analysis was performed from July 12, 2021, to March 15, 2022. For each racial and ethnic group, the difference between trial and CiNA proportions was examined using a 2-sample test for equality of proportions with continuity correction. The 8309 phase 1 trial participants (4198 men [50.5%]; median age, 59 years) included 23 American Indian or Alaska Native participants (0.3%), 371 Asian or Pacific Islander participants (4.5%), 514 Black participants (6.2%), 401 of 5076 Hispanic or Latinx participants (7.9%), and 7154 White participants (86.1%). Industry funded 165 of the 221 trials (74.7%). White patients were overrepresented overall compared with the corresponding CiNA cohort (7154 of 8309 [86.1%] vs 4 113 096 of 4 891 486 [84.1%]; difference, 2.0 percentage points; P < .001). There was an increase in overrepresentation of White patients from 2000 to 2011 (trials, 2780 of 3245 [85.7%]; CiNA, 2 378 019 of 2 800 711 [84.9%]; difference, 0.8 percentage points; P = .23) to 2012-2018 (trials, 4374 of 5063 [86.4%]; CiNA, 1 735 077 of 2 090 775 [82.9%]; difference, 3.5 percentage points; P < .001) and corresponding worsening representation of American Indian or Alaska Native patients (2000-2011: trials, 10 of 3245 [0.3%]; CiNA, 10 905 of 2 800 711 [0.4%]; difference, -0.08 percentage points; 2012-2018: trials, 13 of 5063 [0.3%]; CiNA, 9484 of 2 090 775 [0.5%]; difference, -0.20 percentage points), Asian or Pacific Islander patients (2000-2011: trials, 121 of 3245 [3.7%]; CiNA, 75 033 of 2 800 711 [2.7%]; difference, 1.1 percentage points; 2012-2018: trials, 151 of 5063 [3.0%]; CiNA 70 535 of 2 090 775 [3.4%]; difference, -0.75 percentage points), Black patients (2000-2011: trials, 244 of 3245 [7.5%]; CiNA, 322 701 of 2 800 711 [11.5%]; difference, -4.0 percentage points; 2012-2018: trials, 270 of 5063 [5.3%]; CiNA, 255 625 of 2 090 775 [12.2%]; difference, -6.9 percentage points), and Hispanic or Latinx patients (2000-2011: trials, 161 of 1792 [9.0%]; CiNA, 169 297 of 2 800 711 [6.0%]; difference, 3.0 percentage points; 2012-2018: trials, 240 of 3295 [7.3%]; CiNA, 156 118 of 2 090 775 [7.5%]; difference, -0.2 percentage points). Similar disparities were observed when comparing industry-funded and academic center-sponsored trials. In this cross-sectional study of participants in phase 1 clinical trials of drugs for metastatic cancer, worsening disparities were observed over time in the accrual of patients from racial and ethnic minority groups. These findings may represent widening inequalities in access to trial sites and worsening systemic biases. More efforts are needed to diversify phase 1 cancer drug trials to improve equity in access to new treatments and to ensure that safety and efficacy findings from early drug trials are generalizable across populations.

Association of Race and Ethnicity With Incidence of Dementia Among Older Adults

The racial and ethnic diversity of the US, including among patients receiving their care at the Veterans Health Administration (VHA), is increasing. Dementia is a significant public health challenge and may have greater incidence among older adults from underrepresented racial and ethnic minority groups. To determine dementia incidence across 5 racial and ethnic groups and by US geographical region within a large, diverse, national cohort of older veterans who received care in the largest integrated health care system in the US. Retrospective cohort study within the VHA of a random sample (5% sample selected for each fiscal year) of 1 869 090 participants aged 55 years or older evaluated from October 1, 1999, to September 30, 2019 (the date of final follow-up). Self-reported racial and ethnic data were obtained from the National Patient Care Database. US region was determined using Centers for Disease Control and Prevention (CDC) regions from residential zip codes. Incident diagnosis of dementia (9th and 10th editions of the International Classification of Diseases). Fine-Gray proportional hazards models were used to examine time to diagnosis, with age as the time scale and accounting for competing risk of death. Among the 1 869 090 study participants (mean age, 69.4 [SD, 7.9] years; 42 870 women [2%]; 6865 American Indian or Alaska Native [0.4%], 9391 Asian [0.5%], 176 795 Black [9.5%], 20 663 Hispanic [1.0%], and 1 655 376 White [88.6%]), 13% received a diagnosis of dementia over a mean follow-up of 10.1 years. Age-adjusted incidence of dementia per 1000 person-years was 14.2 (95% CI, 13.3-15.1) for American Indian or Alaska Native participants, 12.4 (95% CI, 11.7-13.1) for Asian participants, 19.4 (95% CI, 19.2-19.6) for Black participants, 20.7 (95% CI, 20.1-21.3) for Hispanic participants, and 11.5 (95% CI, 11.4-11.6) for White participants. Compared with White participants, the fully adjusted hazard ratios were 1.05 (95% CI, 0.98-1.13) for American Indian or Alaska Native participants, 1.20 (95% CI, 1.13-1.28) for Asian participants, 1.54 (95% CI, 1.51-1.57) for Black participants, and 1.92 (95% CI, 1.82-2.02) for Hispanic participants. Across most US regions, age-adjusted dementia incidence rates were highest for Black and Hispanic participants, with rates similar among American Indian or Alaska Native, Asian, and White participants. Among older adults who received care at VHA medical centers, there were significant differences in dementia incidence based on race and ethnicity. Further research is needed to understand the mechanisms responsible for these differences.

Adapting PC CARES to Continue Suicide Prevention in Rural Alaska During the COVID-19 Pandemic: Narrative Overview of an In-Person Community-Based Suicide Prevention Program Moving Online.

This paper presents how a community mobilization program to prevent suicide was adapted to an online format to accommodate the impossibility of in-person delivery in Alaska Native communities during the COVID-19 pandemic. The intervention, Promoting Community Conversations About Research to End Suicide (PC CARES), was created collaboratively by researchers and Alaska Native communities with the goal of bringing community members together to create research-informed and community-led suicide prevention activities in their communities. To continue our work during the COVID-19 pandemic and restrictions, we adapted the PC CARES model to a synchronous remote delivery format. This shift included moving from predominantly Alaska Native participants to one of a mainly non-Native school staff audience. This required a pivot from Alaska Native self-determination toward cultural humility and community collaboration for school-based staff, with multilevel youth suicide prevention remaining the primary aim. This reorientation can offer important insight into how to build more responsive programs for those who are not from the communities they serve. Here, we provide a narrative overview of our collaborative adaptation process, illustrated by data collected during synchronous remote facilitation of the program, and reflect on how the shift in format and audience impacted program delivery and content. The adaptation process strove to maintain the core animating features of self-determination for Alaska Native communities and people as well as the translation of scientific knowledge to practice for greater impact.

Chalazion: racial risk factors for formation, recurrence, and surgical intervention

ObjectiveAn association between race and formation of chalazion has yet to be objectively established. This study investigates race as a risk factor for chalazion and chalazion surgery. Understanding racial risk factors in formation of chalazion, recurrent chalazion, and chalazion requiring surgery (often with general anesthesia in children) informs decisions regarding eyelid hygiene, early topical medical therapy, and aggressiveness with oral antibiotic therapy for coexisting conditions such as blepharitis. MethodsDemographic data was collected for all pediatric visits to the University of Wisconsin-Madison ophthalmology department from 2012–2019. Retrospective chart review was performed for the subset with chalazion. ResultsOf 28 433 minors, 584 had 1088 chalazia, a 2% overall rate. Chalazion was seen in 1.8% of non-Hispanic/Latino participants and 3.8% of Hispanic/Latino participants (p value <0.0001). Chalazion was seen in 1.7% of white participants, compared to 4.3% of American Indian or Alaska Native participants (p value <0.0001) and 4.0% of Asian participants (p value <0.0001). More than one chalazion was recorded in 31% of subjects without coexisting meibomian gland disease, blepharitis, or marginal keratitis, and in 56% (p < 0.0001) with one of these conditions. Repeated diagnoses of chalazion on separate encounters were seen in 17% without these conditions and in 33% (p < 0.0001) with one of these conditions. ConclusionHispanic/Latino, American Indian, and Asian participants developed chalazion at a rate higher than other racial/ethnic groups, whereas patients with meibomian gland disease or blepharitis are especially at risk for developing multiple chalazia on separate encounters. No group was more likely to require surgical intervention than any other.

Demographic diversity of participants in Pfizer sponsored clinical trials in the United States

The approval of new medicinal agents requires robust efficacy and safety clinical trial data demonstrated to be applicable to population subgroups. Limited data have previously been reported by drug sponsors on the topic of clinical trial diversity. In order to establish a baseline of diversity in our clinical trials that can be used by us and other sponsors, an analysis of clinical trial diversity was conducted covering race, ethnicity, sex, and age. This analysis includes Pfizer interventional clinical trials that initiated enrollment between 2011 through 2020. The data set comprises 213 trials with 103,103 US participants. The analysis demonstrated that overall trial participation of Black or African American individuals was at the US census level (14.3% vs 13.4%), participation of Hispanic or Latino individuals was below US census (15.9% vs 18.5%), and female participation was at US census (51.1% vs 50.8%). The analysis also examined the percentage of trials that achieved racial and ethnic distribution levels at or above census levels. Participant levels above census were achieved in 56.1% of Pfizer trials for Black or African American participants, 51.4% of trials for White participants, 16.0% of trials for Asian participants, 14.2% of trials for Native Hawaiian and Pacific Islander participants, 8.5% of trials for American Indian and Alaska Native participants, and 52.3% of trials for Hispanic or Latino participants. The results presented here provide a baseline upon which we can quantify the impact of our ongoing efforts to improve racial and ethnic diversity in clinical trials.

Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials

Medical research has not equitably included members of racial/ethnic minority groups or female and older individuals. There are limited data on participant demographic characteristics in vaccine trials despite the importance of these data to current trials aimed at preventing coronavirus disease 2019. To investigate whether racial/ethnic minority groups and female and older adults are underrepresented among participants in vaccine clinical trials. This cross-sectional study examined data from completed US-based vaccine trials registered on ClinicalTrials.gov from July 1, 2011, through June 30, 2020. The terms vaccine, vaccination, immunization, and inoculation were used to identify trials. Only those addressing vaccine immunogenicity or efficacy of preventative vaccines were included. The numbers and percentages of racial/ethnic minority, female, and older individuals compared with US census data from 2011 and 2018. Secondary outcome measures were inclusion by trial phase and year of completion. A total of 230 US-based trials with 219 555 participants were included in the study. Most trials were randomized (180 [78.3%]), included viral vaccinations (159 [69.1%]), and represented all trial phases. Every trial reported age and sex; 134 (58.3%) reported race and 79 (34.3%) reported ethnicity. Overall, among adult study participants, White individuals were overrepresented (77.9%; 95% CI, 77.4%-78.4%), and Black or African American individuals (10.6%; 95% CI, 10.2%-11.0%) and American Indian or Alaska Native individuals (0.4%; 95% CI, 0.3%-0.5%) were underrepresented compared with US census data; enrollment of Asian individuals was similar (5.7%; 95% CI, 5.5%-6.0%). Enrollment of Hispanic or Latino individuals (11.6%; 95% CI, 11.1%-12.0%) was also low even among the limited number of adult trials reporting ethnicity. Adult trials were composed of more female participants (75 325 [56.0%]), but among those reporting age as a percentage, enrollment of participants who were aged 65 years or older was low (12.1%; 95% CI, 12.0%-12.3%). Black or African American participants (10.1%; 95% CI, 9.7%-10.6%) and Hispanic or Latino participants (22.5%; 95% CI, 21.6%-23.4%) were also underrepresented in pediatric trials. Among trials reporting race/ethnicity, 65 (48.5%) did not include American Indian or Alaska Native participants and 81 (60.4%) did not include Hawaiian or Pacific Islander participants. This cross-sectional study found that among US-based vaccine clinical trials, members of racial/ethnic minority groups and older adults were underrepresented, whereas female adults were overrepresented. These findings suggest that diversity enrollment targets should be included for all vaccine trials targeting epidemiologically important infections.

Wood Products for Cultural Uses: Sustaining Native Resilience and Vital Lifeways in Southeast Alaska, USA

Ongoing revitalization of the &gt;5000-year-old tradition of using trees for vital culture and heritage activities including carving and weaving affirms Alaska Native resilience. However, support for these sustained cultural practices is complicated by environmental and political factors. Carving projects typically require western redcedar (Thuja plicata) or yellow cedar (Callitropsis nootkatensis) trees more than 450 years of age—a tree life stage and growth rate inconsistent with current even-aged forest management strategies. Herein, we qualitatively assess the significance of wood products to rural communities and Indigenous cultures with implications for natural heritage sustainability. In partnership with Alaska Native Tribes, we engaged local youth programs to lead community discussions throughout southeast Alaska to provide specificity to the suite of cultural activities linked to regional forest lands. Results from 58 discussions across 11 southeast Alaska communities (primarily Alaska Native participants) highlighted the cultural importance of forest products including totem poles, dugout canoes, longhouses, woven hats, and woven baskets. Findings indicated spiritual well-being, health, education, tourism, and livelihood significance attributed to these products. Participant-suggested management strategies for increasing supply and expanding access to trees on public lands included: engaging local artisans in forest planning, selecting and delivering specific trees to roads as part of ongoing timber sales, allowing bark removal prior to forest-timber sales, simplifying the tree-acquisition permit process, and setting aside cultural forest groves to sustain trees seven generations into the future. By facilitating discussions, this study fostered relevant place-based youth and community engagement, benefiting youth and enhancing community knowledge transfer while simultaneously summarizing the significance of forest products for resilient culture and heritage activities. Forest management plans aiming to support Alaska Native lifeways may benefit from improved understanding of Indigenous perspectives and worldviews; designation of “culture market values” and “culture targets” can help deliver a broad array of ecosystem services.

Culturally tailored evidence-based substance use disorder treatments are efficacious with an American Indian Southwest tribe: an open-label pilot-feasibility randomized controlled trial.

Many evidence-based treatments (EBTs) for substance use disorder (SUD) exist, yet few are tailored to Indigenous patients. This trial tested the efficacy of a culturally tailored EBT that combined Motivational Interviewing and the Community Reinforcement Approach (MICRA) versus treatment as usual (TAU). A mixed efficacy/effectiveness randomized controlled trial of MICRA (n=38) and TAU (n=41) using a parallel design with follow-up assessments at 4-, 8-, and 12-months post baseline. United States, reservation-based outpatient, addiction specialty care treatment program. 79 (68% male) American Indian and Alaska Native (AI/AN) Tribal members meeting criteria for SUD and seeking SUD treatment. MICRA (individual therapy sessions beginning with MI for 2-3 sessions) compared with TAU (individual and group counseling sessions in a didactic style with Twelve-Step philosophy and elements of relapse prevention). Demographics, percent days abstinent (PDA; the primary outcome at 12months assessed by Form 90D), Inventory of Drug Use Consequences, Alcohol and Drug Use Self-Efficacy Scale, Native American Spirituality Scale, and SCID-DSM-IV-TR. There was no evidence for the benefit of MICRA over TAU (MICRA PDA=72.63%, TAU=73.62%, treatment effect: B = -4.04 (SE=5.47); 95% CI = -14.941, 6.866; BF=3.44) in the primary outcome. Both groups showed improvements in PDA, SUD severity, and negative consequences from baseline to the 12-month follow-up. Neither self-efficacy nor spirituality were significant mediators of MICRA. There were no treatment group differences between culturally tailored evidence-based treatments for substance use disorder and treatment as usual in this randomized controlled trial with American Indian and Alaska Native participants. Nonetheless, participants improved over time on several substance-related outcomes.

Drawing from justice theories to support targets of online harassment

Most content moderation approaches in the United States rely on criminal justice models that sanction offenders via content removal or user bans. However, these models write the online harassment targets out of the justice-seeking process. Via an online survey with US participants ( N = 573), this research draws from justice theories to investigate approaches for supporting targets of online harassment. We uncover preferences for banning offenders, removing content, and apologies, but aversion to mediation and adjusting targets’ audiences. Preferences vary by identities (e.g. transgender participants on average find more exposure to be undesirable; American Indian or Alaska Native participants on average find payment to be unfair) and by social media behaviors (e.g. Instagram users report payment as just and fair). Our results suggest that a one-size-fits-all approach will fail some users while privileging others. We propose a broader theoretical and empirical landscape for supporting online harassment targets.

A prospective cohort analysis of gut microbial co-metabolism in Alaska Native and rural African people at high and low risk of colorectal cancer

Alaska Native (AN) people have the world's highest recorded incidence of sporadic colorectal cancer (CRC) (∼91:100,000), whereas rural African (RA) people have the lowest risk (<5:100,000). Previous data supported the hypothesis that diet affected CRC risk through its effects on the colonic microbiota that produce tumor-suppressive or -promoting metabolites. We investigated whether differences in these metabolites may contribute to the high risk of CRC in AN people. A cross-sectional observational study assessed dietary intake from 32 AN and 21 RA healthy middle-aged volunteers before screening colonoscopy. Analysis of fecal microbiota composition by 16S ribosomal RNA gene sequencing and fecal/urinary metabolites by 1H-NMR spectroscopy was complemented with targeted quantification of fecal SCFAs, bile acids, and functional microbial genes. Adenomatous polyps were detected in 16 of 32 AN participants, but not found in RA participants. The AN diet contained higher proportions of fat and animal protein and less fiber. AN fecal microbiota showed a compositional predominance of Blautia and Lachnoclostridium, higher microbial capacity for bile acid conversion, and low abundance of some species involved in saccharolytic fermentation (e.g., Prevotellaceae, Ruminococcaceae), but no significant lack of butyrogenic bacteria. Significantly lower concentrations of tumor-suppressive butyrate (22.5±3.1 compared with 47.2±7.3 SEM µmol/g) coincided with significantly higher concentrations of tumor-promoting deoxycholic acid (26.7±4.2 compared with 11±1.9 µmol/g) in AN fecal samples. AN participants had lower quantities of fecal/urinary metabolites than RA participants and metabolite profiles correlated with the abundance of distinct microbial genera in feces. The main microbial and metabolic CRC-associated markers were not significantly altered in AN participants with adenomatous polyps. The low-fiber, high-fat diet of AN people and exposure to carcinogens derived from diet or environment are associated with a tumor-promoting colonic milieu as reflected by the high rates of adenomatous polyps in AN participants.

Sleep Duration and Diabetes Risk in American Indian and Alaska Native Participants of a Lifestyle Intervention Project.

We examine the association between self-reported sleep duration and diabetes incidence in a national sample of American Indians/ Alaska Natives (AI/ANs) with prediabetes. Data were derived from the Special Diabetes Program for Indians Diabetes Prevention demonstration project. This longitudinal analysis included 1,899 participants with prediabetes recruited between January 1, 2006 and July 31, 2009 who reported sleep duration and completed all 16 classes of the lifestyle intervention consisting of diet, exercise, and behavior modification sessions to promote weight loss. Three years of follow-up data were included to fit Cox regression models to compute hazard ratios (HRs) for diabetes incidence across sleep duration categories. The crude diabetes incidence rate was 4.6 per 100 person-years among short sleepers (≤ 6 h per night) compared to 3.2 among those sleeping 7 h and 3.3 among those sleeping 8 h or more. After adjustment for age and sex, short sleep (≤ 6 h vs. others) was associated with increased diabetes risk (HR 1.55 [95% confidence interval 1.11-2.17]); risk remained significantly elevated after controlling for socioeconomic characteristics, health behaviors, and health status. When adjusting for body mass index and percent weight loss, the short sleep-diabetes relationship was attenuated (HR 1.32 [95% confidence interval 0.92-1.89]). No significant long sleep-diabetes association was found. Further, short sleepers lost significantly less weight than others (3.7% vs. 4.3%, P = 0.003). Short sleep duration, but not long duration, was significantly associated with increased diabetes risk and less weight loss among AI/ANs in a lifestyle intervention. Further exploration of the complex factors underlying short sleep duration is warranted.