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Background: Psychosocial distress is common after a diagnosis of breast cancer. Little is known about the informational needs and the psychosocial adjustment of patients diagnosed with metastatic breast cancer (MBC) within the first year of their diagnosis. Methods: Patients with MBC from a single academic institution completed a cross- sectional self-administered paper survey. The survey included demographics, the Medical Outcomes Study Short Form-36 (SF-36), the Hospital Anxiety and Depression Scale (HADS), and Toronto Informational Needs Questionnaire-Breast Cancer (TINQ). Medical history was obtained by chart review. The Spearman correlation coefficient assessed the relationship between TINQ and the following: age at MBC diagnosis, disease free interval (DFI), time between survey completion and MBC diagnosis, number of lines of therapy, and HADS. Results: Fifty-two (90%, 50F 2M) patients completed the survey. Median age at MBC diagnosis was 52 yrs (range 22-81). Thirty-nine (75%) patients had completed college, 92% were Caucasian. Median time between MBC diagnosis and survey completion was 6 months (range 1-12). Sixteen (31%) patients had de novo stage 4 disease. At time of survey completion, 36 (69%) patients were on 1st line therapy with some patients were receiving their 4th line of therapy. SF-36 scores were lower in all 8 subscales compared to the general population. In particular, role limitations due to physical health (Norm-based transformation mean score 39.3, SD=12.1), social functioning (Mean 41.8, SD=12.7), role limitations due to emotional problems (Mean 43.3, SD=13.3), vitality (Mean 44.1, SD=10.8) and general health (Mean 44.3, SD=12.1) were diminished. The Physical and Mental Component Summary norm-based transformation scores were 43.2 (SD = 11.7) and 45.4 (SD = 11.3) respectively.9/48 (19%) patients met criteria for anxiety, and 4/48 (8%) patients met criteria for depression by HADS criteria (scores > 11). TINQ scores range from 51 to 255, with 35/52 (69%) having a total score > 200, suggesting high informational need. Of the 5 subscales, treatment information was most important, followed by information about disease, physical care, psychosocial needs and investigative tests. The most important informational issues for patients were: if there was cancer anywhere else in their body (Mean score 4.78), how to deal with side effects (Score 4.78), and if there were ways to prevent treatment side effects (Score 4.77), with a score of 5=extremely important, and 1= not important. Only DFI correlated with TINQ (Spearman coefficient -0.413, p = 0.011), with patients who had a shorter DFI having greater informational needs. Age at MBC diagnosis, time of completion of survey, number of lines and HADS were not significant. Conclusion: Based on this study, patients with recently diagnosed MBC have high informational needs and poor psychosocial adjustment. The overall quality of life appears to be worse in this population of patients compared to the general population. There is also a subset of patients who are dealing with significant anxiety and depression. Additional research, education, and supportive care services aimed at meeting the informational and psychosocial needs of women living with MBC are warranted. [ABSTRACT FROM AUTHOR]

Background/objectives: Retinal vascular occlusions, such as retinal vein occlusion (RVO) and retinal artery occlusion (RAO), are associated with cognitive impairment, including dementia. Our objective was to examine the odds of dementia among patients with retinal vascular occlusion., Methods: This cross-sectional study included 474 patients with retinal vascular occlusion and 948 patients without retinal vascular occlusion (comparison group). Patients in the comparison group were age- and sex-matched to those with vascular occlusion. Logistic regression was used to analyze the odds of all-cause dementia, vascular dementia, and Alzheimer's disease after adjusting for demographic, clinical, and ophthalmic covariates. Main outcome measures included the presence of all-cause dementia, vascular dementia, and Alzheimer's disease., Results: Patients with RVO (n = 413) had increased odds for all-cause dementia (odds ratio (OR) = 2.32; 95% confidence interval (CI): 1.44-3.75; p < 0.001) and vascular dementia (OR = 3.29; 95% CI: 1.41-7.68; p = 0.006) relative to the comparison group. Patients with central RVO (n = 192) (OR = 2.32; 95% CI: 1.19-4.54; p = 0.014) or branch RVO (n = 221) (OR = 2.68; 95% CI: 1.30-5.50; p = 0.007) had increased odds for all-cause dementia relative to the comparison group. Patients with RAO (n = 61) did not have increased odds of all-cause dementia (OR = 1.01; 95% CI: 0.32-3.26; p = 0.983), vascular dementia (OR = 1.54; 95% CI: 0.22-10.81; p = 0.663), or Alzheimer's disease (OR = 0.32; 95% CI: 0.05-2.20; p = 0.244)., Conclusions: A history of any RVO is associated with increased rates of all-cause dementia and vascular dementia independent of shared cardiovascular risk factors. These associations are not seen with a history of RAO, or between any subtype of vascular occlusions and Alzheimer's disease.

Due to historical and ongoing structural racism and settler colonialism, Indigenous Peoples and communities in the United States are at a higher risk for a variety of diseases, elevated stress, and negative mental health outcomes. In addition, the United States federal government and the public encourage a view that Indigenous Peoples are primarily a racial group. Federally-, state-, and un-recognized Indigenous Peoples have a collective right to self-determination and sovereignty, and individuals of these Peoples understand this. The goals of this scoping review were to examine what research on identity and mental well-being is currently being conducted with Indigenous populations in the United States, synthesize the results, and determine if researchers are utilizing toolsets and theories that reinforce the sovereignty of Indigenous Peoples, communities, and the individual. The scoping review followed guidelines from the Joanna Briggs Institute guide for Scoping Reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews (PRISMA-ScR). Four databases and over six thousand articles were searched for this review, with twenty-four that had data extracted and analyzed. Current research on the relationship between Indigenous identity and mental well-being shows mixed results. The findings of this scoping review highlight a need for Indigenous-specific tools for measuring identity in place of tools used for other ethnic and racial groups. More research must be conducted to create tools that specifically examine the phenomena of United States-based Indigenous identity.

Indigenous Peoples are reimagining their relationship with research and researchers through greater self-determination and involvement in research governance. The emerging discourse around Indigenous Data Sovereignty has provoked discussions about decolonizing data practices and highlighted the importance of Indigenous Data Governance to support Indigenous decision-making and control of data. Given that much data are generated from research, Indigenous research governance and Indigenous Data Governance overlap. In this paper, we broaden the concept of Indigenous Data Sovereignty by using the CARE Principles for Indigenous Data Governance to discuss how research legislation and policy adopted by Indigenous Peoples in the US set expectations around recognizing sovereign relationships, acknowledging rights and interests in data, and enabling Indigenous Peoples' participation in research governance., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Garba, Sterling, Plevel, Carson, Cordova-Marks, Cummins, Curley, David-Chavez, Fernandez, Hiraldo, Hiratsuka, Hudson, Jäger, Jennings, Martinez, Yracheta, Garrison and Carroll.)

Introduction: The Navajo Nation is a large sovereign tribal nation. After several years of grassroots efforts and overcoming an initial presidential veto, the Navajo Nation passed the Healthy Diné Nation Act (HDNA) in 2014 to promote healthy behaviors in Navajo communities. This was the first such policy in the US and in any sovereign tribal nation worldwide., Purpose and Objectives: The objective of this study was to describe the process, implementation, and evaluation of the HDNA passage and its 2020 reauthorization and the potential for using existing and tribal-specific data to inform tribal policy making., Intervention Approach: The HDNA included a 2% tax on unhealthy foods sold on the Navajo Nation and waived a 6% sales tax on healthy foods. HDNA-generated funds were allocated to 110 local communities for wellness projects. No funds were allocated for enforcement or compliance., Evaluation Methods: We assessed HDNA tax revenue and tax-funded wellness projects in 110 chapters over time, by region and community size. The food store environment was assessed for fidelity of HDNA implementation, price changes since pretax levels, and shopper behaviors. HDNA revenue was cross-matched with baseline nutrition behaviors and health status through a Navajo-specific Behavioral Risk Factor Surveillance System survey., Results: HDNA revenue decreased modestly annually, and 99% of revenue was disbursed to local chapters, mostly for the built recreational environment, education, equipment, and social events. Stores implemented the 2% tax accurately, and the food store environment improved modestly. Regions with high tax revenue also had high rates of diabetes, but not other chronic conditions. The HDNA was reauthorized in 2020., Implications for Public Health: Sovereign tribal nations can drive their own health policy. Program evaluation can use existing data sources, tailored data collection efforts, and tribal-specific surveys to gain insight into feasibility, implementation, and impact.

The COVID-19 pandemic led to the creation of a new protest movement, positioned against government lockdowns, mandatory vaccines, and related measures. Efforts to control misinformation by digital platforms resulted in take downs of key accounts and posts. This led some of these protest groups to migrate to platforms with less stringent content moderation policies, such as Telegram. Telegram has also been one of the destinations of the far right, whose deplatforming from mainstream platforms began a few years ago. Given the co-existence of these two movements on Telegram, the article examines their connections. Empirically, the article focused on Irish Telegram groups and channels, identifying relevant protest movements and collecting their posts. Using computational social science methods, we examine whether far-right terms and discourses are present and how this varies across different clusters of Telegram Covid-19 protest groups. In addition, we examine which actors are posting far-right content and what kind of roles they play in the network of Telegram groups. The findings indicate the presence of far-right discourses among the COVID-19 groups. However, the existence of these groups was not solely driven by the extreme right, and the incidence of far-right discourses was not equal across all COVID-19 protest groups. We interpret these findings under the prism of the mediation opportunity structure: while the far right appears to have taken advantage of the network opportunity structure afforded by deplatforming and the migration to Telegram, it did not succeed in diffusing its ideas widely among the COVID-19 protest groups in the Irish Telegram., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2022.)

Objective: The authors sought to identify the most promising strategies for improving the mental health guardianship process in Los Angeles County for adults with mental illness who are gravely disabled., Methods: In May and June 2019, 56 experts, working in hospitals or outpatient facilities or representing legal, advocacy, policy, or forensic organizations, participated in an online modified-Delphi panel, rating the ethical appropriateness, impact on care quality, efficiency, and feasibility of nine strategies for improvement of mental health guardianship. Agreement was determined with the RAND/UCLA appropriateness method, and comments were thematically analyzed., Results: The strategy ranked highest by the participating experts was improving the administrative functioning and judicial processes of entities involved in mental health guardianship proceedings-it was the only strategy that achieved agreement among panelists and was rated highly on all four criteria. Other preferred strategies were enhancing the ability of assertive outpatient mental health teams to serve individuals before they experience a crisis and expanding the continuum of unlocked residential treatment settings., Conclusions: Opportunities exist to improve all stages of the mental health guardianship process. Experts favored strategies that streamline administrative processes, facilitate community integration into treatment, and ensure fidelity to best practices. Improving the mental health guardianship process has the potential to speed up delivery of services, better manage resources, and increase access to treatment for individuals with mental illness who are gravely disabled.

Background: In 2014, the Navajo Nation passed the Healthy Diné Nation Act (HDNA), which applies an additional 2% tax on unhealthy foods and beverages and a waiver of Navajo sales tax on healthy foods and beverages. However, the HDNA's impact on purchasing behavior has not been explored., Objectives: We assessed beverage and produce purchasing trends among shoppers at small Navajo stores between 2017 and 2019, shopper characteristics associated with buying water, and whether HDNA awareness was associated with purchasing behaviors., Methods: A total of 332 shoppers at 34 stores in 2017 and 274 shoppers at 44 stores in 2019 were surveyed to assess HDNA awareness and same-day purchasing of water, sugar-sweetened beverages (SSBs), fruits, and vegetables. Hypotheses were tested using chi-square analyses and multivariate analysis., Results: Water purchasing among respondents increased significantly from 2017 to 2019 (24.4% to 32.8%; P  = 0.03). Shoppers in 2019 were 1.5 times more likely to purchase water compared with 2017 (adjusted P = 0.01). There was a trend toward reduced SSB purchasing (85.8% in 2017, 80.3% in 2019, P  = 0.068), while produce purchasing remained unchanged over time, at approximately 17%. Shoppers were more likely to buy water if they relied on that store for the majority of their groceries ( P  = 0.006) and if they did not have their own transportation to get to the store ( P  = 0.004). Most shoppers (56.6%) were aware of the HDNA; of these, 35.6% attributed healthier habits to the HDNA, most commonly buying more healthy drinks (49.2%), fewer unhealthy drinks (37.7%), more healthy snacks (31.1%), and fewer unhealthy snacks (26.2%)., Conclusions: Shopper habits at small stores located on the Navajo Nation have shifted towards healthier purchasing from 2017 to 2019. Shoppers who were aware of the HDNA reported purchasing more healthy and fewer unhealthy food and drinks as a result of this legislation., (© The Author(s) 2022. Published by Oxford University Press on behalf of the American Society for Nutrition.)

In 2014, the Navajo Nation Council passed the Healthy Diné Nation Act (HDNA), a 2% tax on unhealthy foods and beverages and a waiver of the 5% sales tax on healthy foods and water, to support health promotion and disease prevention among the Navajo people. Very little research has assessed implementation accuracy of food or beverage taxes and none were implemented within a sovereign Tribal nation. This study assessed the accuracy of HDNA tax implementation among 47 stores located on the Navajo Nation. A pair of tax-exempt items [e.g. a bottle of water and fresh fruit] and a pair of HDNA-tax eligible items [e.g. sugary beverage and candy bar] were purchased between July-December 2019. Receipts were retained to assess taxation. A total of 87.2% of stores accurately implemented the 2% tax on unhealthy items while 55.3% of the stores accurately implemented the 6% tax waiver on healthy items. In all, 51.1% of the stores accurately applied both taxes. There were no significant differences across store type (convenience or grocery stores and trading posts) or geographic region. In conclusion, almost all stores on the Navajo Nation accurately applied a 2% tax on unhealthy foods and beverages, while the proportion of stores applying a waiver on healthy foods was lower. Successful HDNA tax implementation among stores remains an important priority in achieving the goal to support health promotion and disease prevention among Navajo communities., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Introduction: In 2014, the Navajo Nation Healthy Diné Nation Act (HDNA) was passed, combining a 2% tax on foods of 'minimal-to-no-nutritional value' and waiver of 5% sales tax on healthy foods, the first-ever such tax in the U.S. and globally among a sovereign tribal nation. The aim of this study was to measure changes in pricing and food availability in stores on the Navajo Nation following the implementation of the HDNA., Methods: Store observations were conducted in 2013 and 2019 using the Nutrition Environment Measurement Survey-Stores (NEMS-S) adapted for the Navajo Nation. Observations included store location, type, whether healthy foods or HDNA were promoted, and availability and pricing of fresh fruits and vegetables, canned items, beverages, water, snacks and traditional foods. Differences between 2013 and 2019 and by store type and location were tested., Results: The matched sample included 71 stores (51 in the Navajo Nation and 20 in border towns). In 2019, fresh produce was available in the majority of Navajo stores, with 71% selling at least 3 types of fruit and 65% selling at least 3 types of vegetables. Compared with border town convenience stores, Navajo convenience stores had greater availability of fresh vegetables and comparable availability of fresh fruit in 2019. The average cost per item of fresh fruit decreased by 13% in Navajo stores (from $0.88 to $0.76) and increased in border stores (from $0.63 to $0.73), resulting in comparable prices in Navajo and border stores in 2019. While more Navajo stores offered mutton, blue corn and wild plants in 2019 compared to 2013, these changes were not statistically significant., Discussion: The findings suggest modest improvements in the Navajo store environment and high availability of fruits and vegetables. Navajo stores play an important role in the local food system and provide access to local, healthy foods for individuals living in this rural, tribal community., Competing Interests: The authors have declared that no competing interests exist.

We determined the efficacy of tocilizumab (TCZ) in preventing grade 2-4 acute graft-versus-host disease (aGVHD) in patients with acute leukemia or myelodysplasia undergoing matched sibling donor (MSD) or volunteer unrelated donor (VUD) allogeneic stem cell transplantation after myeloablative or reduced-intensity conditioning across 5 Australian centers. A total of 145 patients (50 MSD, 95 VUD) were randomly assigned to placebo or TCZ on day -1. All patients received T-cell-replete peripheral blood stem cell grafts and graft-versus-host disease (GVHD) prophylaxis with cyclosporin/methotrexate. A planned substudy analyzed the VUD cohort. With a median follow-up of 746 days, the incidence of grade 2-4 aGVHD at day 100 for the entire cohort was 36% for placebo vs 27% for TCZ (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.38-1.26; P = .23) and 45% vs 32% (HR, 0.61; 95% CI, 0.31-1.22; P = .16) for the VUD subgroup. The incidence of grade 2-4 aGVHD at day 180 for the entire cohort was 40% for placebo vs 29% for TCZ (HR, 0.68; 95% CI, 0.38-1.22; P = .19) and 48% vs 32% (HR, 0.59; 95% CI, 0.30-1.16; P = .13) for the VUD subgroup. Reductions in aGVHD were predominantly in grade 2 disease. For the entire cohort, transplant-related mortality occurred in 8% vs 11% of placebo-treated vs TCZ-treated patients, respectively (P = .56), and overall survival was 79% vs 71% (P = .27). Median day to neutrophil and platelet engraftment was delayed by 2 to 3 days in TCZ-treated patients, whereas liver toxicity and infectious complications were similar between groups. In this phase 3 randomized double-blind trial, TCZ showed nonsignificant trends toward reduced incidence of grade 2-4 aGVHD in recipients from HLA-matched VUDs but no improvements in long term-survival., (© 2021 by The American Society of Hematology.)

Worksites with on-site operations have experienced coronavirus disease (COVID-19) outbreaks. We analyzed data for 698 nonresidential, nonhealthcare worksite COVID-19 outbreaks investigated in Los Angeles County, California, USA, during March 19, 2020‒September 30, 2020, by using North American Industry Classification System sectors and subsectors. Nearly 60% of these outbreaks occurred in 3 sectors: manufacturing (n = 184, 26.4%), retail trade (n = 137, 19.6%), and transportation and warehousing (n = 73, 10.5%). The largest number of outbreaks and largest number and highest incidence rate of outbreak-associated cases occurred in manufacturing. Furthermore, 7 of the 10 industry subsectors with the highest incidence rates were within manufacturing. Approximately 70% of outbreak-associated case-patients reported Hispanic ethnicity. Facilities employing more on-site staff had larger and longer outbreaks. Identification of highly affected industry sectors and subsectors is necessary for targeted public health planning, outreach, and response, including ensuring vaccine access, to reduce burden of COVID-19 in vulnerable workers.

Our study summarizes tax revenue and disbursements from the Navajo Nation Healthy Diné Nation Act of 2014, which included a 2% tax on foods of minimal-to-no nutritional value (junk food tax), the first in the United States and in any sovereign tribal nation. Since the tax was implemented in 2015, its gross revenue has been $7.58 million, including $1,887,323 in 2016, the first full year. Revenue decreased in absolute value by 3.2% in 2017, 1.2% in 2018, and 4.6% in 2019, a significant downward trend (P = .02). Revenue allocated for wellness projects averaged $13,171 annually for each local community, with over 99% successfully disbursed and more rural areas generating significantly less revenue. Our results provide context on expected revenue, decreases over time, and feasibility for tribal and rural communities considering similar policies.

Introduction: The Community Outreach and Patient Empowerment (COPE) intervention provides integrated outreach through community health representatives (CHRs) to people living with diabetes in Navajo Nation. The aim of this study was to identify groups for whom the intervention had the greatest effect on glycated hemoglobin A 1c (HbA 1c )., Methods: We analyzed de-identified data extracted from routine health records dated from December 1, 2010, through August 31, 2014, to compare net change in HbA 1c among COPE patients and non-COPE patients. We used linear mixed models to assess whether the intervention was modified by age, sex, preferred language, having a primary care provider, baseline HbA 1c , or having a mental health condition., Results: Age, having a primary care provider, and baseline HbA 1c significantly modified HbA 1c levels. Among patients aged 64 or younger, COPE participation was associated with a net decrease in HbA 1c of 0.77%; among patients aged 65 or older, the net decrease was 0.49% (P = .03). COPE participation was associated with a steeper decrease in HbA 1c among patients without a primary care physician (net decrease, 0.99%) than among patients with a primary care provider (net decrease, 0.57%) (P = .03). COPE patients with a baseline HbA 1c >9% had a net decrease of 0.70%, while those with a baseline HbA 1c ≤9% had a net decrease of 0.34% (P = .01). We found no significant differences based on sex, preferred language, or having a mental health condition., Conclusion: Findings suggest that the COPE intervention was robust and equitable, benefiting all groups living with diabetes in Navajo Nation, but conferring the greatest benefit on the most vulnerable.

Increased epithelial permeability is a key feature of IBD pathogenesis and it has been proposed that agents which promote barrier function may be of therapeutic benefit. We have previously reported the secondary bile acid, ursodeoxycholic acid (UDCA), to be protective in a mouse model of colonic inflammation and that its bacterial metabolism is required for its beneficial effects. The current study aimed to compare the effects of UDCA, LCA, and a non-metabolizable analog of UDCA, 6-methyl-UDCA (6-MUDCA), on colonic barrier function and mucosal inflammation in a mouse model of colonic inflammation. Bile acids were administered daily to C57Bl6 mice by intraperitoneal injection. Colonic inflammation, induced by addition of DSS (2.5%) to the drinking water, was measured as disease activity index (DAI) and histological score. Epithelial permeability and apoptosis were assessed by measuring FITC-dextran uptake and caspase-3 cleavage, respectively. Cecal bile acids were measured by HPLC-MS/MS. UDCA and LCA, but not 6-MUDCA, were protective against DSS-induced increases in epithelial permeability and colonic inflammation. Furthermore, UDCA and LCA inhibited colonic epithelial caspase-3 cleavage both in DSS-treated mice and in an in vitro model of cytokine-induced epithelial injury. HPLC-MS/MS analysis revealed UDCA administration to increase colonic LCA levels, whereas LCA administration did not alter UDCA levels. UDCA, and its primary metabolite, LCA, protect against intestinal inflammation in vivo, at least in part, by inhibition of epithelial apoptosis and promotion of barrier function. These data suggest that clinical trials of UDCA in IBD patients are warranted., (© 2020 The Authors. Physiological Reports published by Wiley Periodicals LLC on behalf of The Physiological Society and the American Physiological Society.)

Background: Navajo community members face high rates of diabetes mellitus and other chronic diseases. The Navajo Community Health Representative Outreach Program collaborated with healthcare providers and academic partners to implement structured and coordinated outreach to patients living with diabetes. The intervention, called Community Outreach and Patient Empowerment or COPE, provides home-based health coaching and community-clinic linkages to promote self-management and engagement in healthcare services among patients living with diabetes. The purpose of this study was to evaluate how outreach by Navajo Community Health Representatives ("COPE Program") affected utilization of health care services among patients living with diabetes., Methods: De-identified data from 2010 to 2014 were abstracted from electronic health records at participating health facilities. In this observational cohort study, 173 cases were matched to 2880 controls. Healthcare utilization was measured as the number of times per quarter services were accessed by the patient. Changes in utilization over 4 years were modeled using a difference-in-differences approach, comparing the trajectory of COPE patients' utilization before versus after enrollment with that of the control group. The model was estimated using generalized linear mixed models for count outcomes, controlling for clustering at the patient level and the service unit level., Results: COPE enrollees showed a 2.5% per patient per quarter (pppq) greater increase in total utilization (p = 0.001) of healthcare services than non-COPE enrollees; a 3.2% greater increase in primary care visits (p = 0.024); a 6.3% greater increase in utilization of counseling and behavioral health services (p = 0.013); and a 9.0% greater increase in pharmacy visits (p <  0.001). We found no statistically significant differences in utilization trends of inpatient, emergency room, specialty outpatient, dental, laboratory, radiology, or community encounter services among COPE participants versus control., Conclusions: A structured intervention consisting of Community Health Representative outreach and coordination with clinic-based providers was associated with a modest increase in health care utilization, including primary care and counseling services, among Navajo patients living with diabetes. Community health workers may provide an important linkage to enable patients to access and engage in clinic-based health care., Trial Registration: NCT03326206, registered 10/31/2017, retrospectively registered.

Objective: To understand providers' opinions about the Community Outreach and Patient Empowerment (COPE) Project designed to strengthen Navajo Community Health Representative (CHR) outreach to individuals living with diabetes., Design: This was a qualitative study nested within a larger evaluation of a programme intervention., Setting: The study took place in Navajo Nation and evaluated a programme initiative designed to strengthen collaboration between CHRs and clinic-based healthcare providers and provide structured outreach to individuals living with diabetes in Navajo Nation. The CHR Programme is a formal community health worker programme that exists in most tribal healthcare systems across the USA., Participants: Healthcare providers involved in the programme took part in one-on-one interviews., Analysis: We used thematic analysis for this study. A team of three study staff used open-coding to create a codebook. Coded material were summarised and patterns were identified and tied into a narrative using concept mapping. The study design and instrument construction were guided by a Community Health Advisory Panel., Results: A total of 13 interviews were completed. Providers acknowledged CHRs as an asset to the clinical team and were enthusiastic about the COPE coaching materials, mentioning they provided a consistent message to CHRs and the community. Providers that led COPE trainings with CHRs valued the face-to-face time and opportunity to build relationships. Providers (n=4) supported CHRs' access to electronic health record to record patient visits and streamline referrals. Among their requests were having designated personnel to manage referrals with CHRs and a formal system to record modules CHRs have completed., Conclusion: Providers participating in COPE activities valued the work of CHRs and endorsed further strengthening relationships and communication with CHRs. Healthcare programmes should consider systems changes to integrate community health workers into clinic-based teams., Trial Registration Number: NCT03326206; Results., Competing Interests: Competing interests: ShS discloses that she has served as the executive director for a 501(c)3 organisation, entitled Community Outreach and Patient Empowerment Program, which continues to support the described programme, since study completion., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Community Health Representatives (CHRs) overcome health disparities in Native communities by delivering home care, health education, and community health promotion. The Navajo CHR Program partners with the non-profit Community Outreach and Patient Empowerment (COPE), to provide home-based outreach to Navajo clients living with diabetes. COPE has created an intervention (COPE intervention) focusing on multiple levels of improved care including trainings for CHRs on Motivational Interviewing and providing CHRs with culturally-appropriate education materials. The objective of this research is to understand the participant perspective of the CHR-COPE collaborative outreach through exploring patient-reported outcomes (PROs) of clients who consent to receiving the COPE intervention (COPE clients) using a qualitative methods evaluation., Methods: Seven COPE clients were selected to participate in semi-structured interviews one year after finishing COPE to explore their perspective and experiences. Qualitative interviews were recorded, transcribed, and coded to identify themes., Results: Clients revealed that health education delivered by CHRs facilitated lifestyle changes by helping them understand key health indicators and setting achievable goals through the use of accessible material and encouragement. Clients felt comfortable with CHRs who respected traditional practices and made regular visits. Clients also appreciated when CHRs educated their family members, who in turn were better able to support the client in their health management. Finally, CHRs who implemented the COPE intervention helped patients who were unable to regularly see a primary care doctor for critical care and support in their disease management., Conclusion: The COPE-CHR collaboration facilitated trusting client-CHR relationships and allowed clients to better understand their diagnoses. Further investment in materials that respect traditional practices and aim to educate clients' families may foster these relationships and improve health outcomes., Trial Registration: clinicaltrials.gov: NCT03326206. Registered 9/26/2017 (retrospectively registered).

Background: We studied the impact of Community Outreach and Patient Empowerment (COPE) intervention to support Community Health Representatives (CHR) on the clinical outcomes of patients living with diabetes in the Navajo Nation extending into the States of Arizona, Utah, and New Mexico. The COPE intervention integrated CHRs into healthcare teams by providing a structured approach to referrals and home visits., Methods: We abstracted routine clinical data from the Indian Health Service's information system on individuals with diabetes mellitus seen at participating clinical sites from 2010 to 2014. We matched 173 COPE participants to 2880 patients with similar demographic and clinical characteristics who had not participated in COPE. We compared the changes in clinical outcomes between the two groups using linear mixed models., Results: Over the four years of the study, COPE patients had greater improvements in glycosylated hemoglobin (- 0.56%) than non-COPE participants (+ 0.07%) for a difference in differences of 0.63% (95% confidence interval (CI): 0.50, 0.76). Low-density lipoprotein fell more steeply in the COPE group (- 10.58 mg/dl) compared to the non-COPE group (- 3.18 mg/dl) for a difference in differences of 7.40 mg/dl (95%CI: 2.00, 12.80). Systolic blood pressure increased slightly more among COPE (2.06 mmHg) than non-COPE patients (0.61 mmHg). We noted no significant change for body mass index in either group., Conclusion: Structured outreach by Community Health Representatives as part of an integrated care team was associated with improved glycemic and lipid levels in the target Navajo population., Trial Registration: Trial registration: NCT03326206. Registered 31 October 2017 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/study/NCT03326206.

Allogeneic stem cell transplantation (SCT) is a curative therapy for patients with hematological malignancies related largely to an immunological graft-versus-leukemia (GVL) effect mediated by donor T cells and natural killer cells. Relapse of disease after SCT represents failure of GVL and is now the major cause of treatment failure. We sought to augment GVL effects in patients (n = 29) relapsing after SCT in a prospective phase I/II clinical trial of dose-escalated pegylated interferon-2α (peg-IFNα). The administration of peg-IFNα after reinduction chemotherapy, with or without subsequent donor lymphocyte infusion (DLI), resulted in a 2-year overall survival (OS) of 31% (95% confidence interval, 17.3%-49.2%), which rejects the null hypothesis of 7% generated by observations in an institutional historical cohort. As expected, peg-IFNα was associated with graft-versus-host disease (GVHD) and hematological toxicity, which was manageable with scheduled dose modifications. Progression-free survival (PFS) was greatest in patients who experienced GVHD, although the majority of those patients still eventually progressed. Higher PFS and OS were associated with pretreatment proportions of immune cell populations with regulatory function, including mucosal invariant T cells, regulatory T cells, and plasmacytoid dendritic cells, independent of any association with GVHD. Peg-IFNα administration after relapse thus constitutes a logical strategy to invoke GVL effects and should be studied in a larger, multicenter cohort. This trial was registered at www.anzctr.org.au as #ACTRN12612000728831., (© 2019 by The American Society of Hematology.)

Objective: Racial/ethnic minorities experience disparities in depression1 and there is a paucity of evidence-based interventions to improve depression care access and outcomes. Community Partners in Care (CPIC) is a community-partnered study of depression care quality improvement (QI) in under-resourced, urban communities: Community Engagement and Planning (CEP) for multi-sector coalitions, and Resources for Services (RS) for program technical assistance.2 CEP demonstrated benefits for the overall CPIC study population; effects for Black and Latino sub-populations are unknown., Methods: This sub-analysis examines outcomes for 409 Latino and 488 Black (non-Latino) adults recruited from 90 programs who completed baseline or 6-month follow-up. Regression analyses were used to estimate CEP vs RS intervention effects on primary (Mental Health Related Quality of Life [MHRQL], Patient Health Questionnaire-9 [PHQ-9]) and community-prioritized (mental wellness, physical activity, risk for homelessness) outcomes at 6-months., Results: Baseline characteristics did not differ significantly by intervention in either group. In the adjusted analysis for Black adults, CEP resulted in decreased odds of poor MHRQL (OR: .62, 95% CI=.41-.94, P=.028) with a trend for reducing homelessness risk (OR: .60, .35-1.05, P=.69). For Latino adults, CEP resulted in greater probability of mental wellness (OR: 1.81, 1.05-3.13, P=.034) and a trend for increased physical activity (OR: 1.52, .93-2.49, P=.091)., Conclusions: Exploratory analyses of CEP for depression quality improvement suggests significant 6-month benefits in mental health outcomes for Black and Latino participants and trends for improvement in community-prioritized outcomes for both groups. Findings may inform research in multi-sector coalitions to promote equity in depression care., Competing Interests: Competing Interests: None declared.

Background: Native American communities experience greater burden of diabetes than the general population, including high rates of Type 2 diabetes among women of childbearing age. Diabetes in pregnancy is associated with risks to both the mother and offspring, and glycemic control surrounding the pregnancy period is of vital importance., Methods: A retrospective chart review was conducted at a major Navajo Area Indian Health Service (IHS) hospital, tracking women with pre-existing diabetes who became pregnant between 2010 and 2012. Logistic regression was performed to find patient-level predictors of our desired primary outcome-having hemoglobin A1c (HbA1c) consistently < 8% within 2 years after pregnancy. Descriptive statistics were generated for other outcomes, including glycemic control and seeking timely IHS care., Results: One hundred twenty-two pregnancies and 114 individuals were identified in the dataset. Baseline HbA1c was the only covariate which predicted our primary outcome (OR = 1.821, 95% CI = 1.184-2.801). Examining glycemic control among pregnancies with complete HbA1c data (n = 59), 59% were controlled before, 85% during, and 34% after pregnancy. While nearly all women received care in the immediate postpartum period, only 49% of women visited a primary care provider and 71% had HbA1c testing in the 2 years after pregnancy., Conclusions: This is the first analysis of outcomes among women with diabetes in pregnancy in Navajo Nation, the largest reservation and tribal health system in the United States. Our findings demonstrate the positive impact of specialized prenatal care in achieving glycemic control during pregnancy, while highlighting the challenges in maintaining glycemic control and continuity of healthcare after pregnancy.

Objective: The objective of this study was to identify risk factors for 30-day readmission events for American Indian patients with diabetes in the southwest., Research Design and Methods: Data from patients with diabetes admitted to Gallup Indian Medical Center between 2009 and 2016 were analyzed using logistic regression analyses., Results: Of 2,660 patients, 394 (14.8%) patients had at least one readmission within 30 days of discharge. Older age (OR (95% CI) = 1.26, (1.17, 1.36)), longer length of stay (OR (95% CI) = 1.01, (1.0001, 1.0342)), and a history of substance use disorder (OR (95% CI) = 1.80, (1.25, 2.60)) were risk factors for 30-day readmission. An American Indian language preference was protective against readmission., Conclusions: Readmission events are complex and may reflect broad and interwoven disparities in community systems. Future research should work to support community-defined interventions to address both in hospital and external factors that impact risk factors for readmission., Competing Interests: Dr. Shin is employed at Brigham and Women’s Hospital and serves as PI for the PCORI contract. She is also the Executive Director of an affiliated 501(c)3 called Community Outreach and Patient Empowerment Program, Inc. which she serves in a volunteer capacity. The remaining authors state that they have no conflict of interest. This does not alter the authors’ adherence to PLOS ONE policies on sharing data and materials.

Background: Strengthening Community Health Worker systems has been recognized to improve access to chronic disease prevention and management efforts in low-resource communities. The Community Outreach and Patient Empowerment (COPE) Program is a Native non-profit organization with formal partnerships with both the Navajo Nation Community Health Representative (CHR) Program and the clinical facilities serving the Navajo Nation. COPE works to better integrate CHRs into the local health care system through training, strengthening care coordination, and a standardized culturally appropriate suite of health promotion materials for CHRs to deliver to high-risk individuals in their homes., Methods: The objective of this mixed methods, cross sectional evaluation of a longitudinal cohort study was to explore how the COPE Program has effected CHR teams over the past 6 years. COPE staff surveyed CHRs in concurrent years (2014 and 2015) about their perceptions of and experience working with COPE, including potential effects COPE may have had on communication among patients, CHRs, and hospital-based providers. COPE staff also conducted focus groups with all eight Navajo Nation CHR teams., Results: CHRs and other stakeholders who viewed our results agree that COPE has improved clinic-community linkages, primarily through strengthened collaborations between Public Health Nurses and CHRs, and access to the Electronic Health Records. CHRs perceived that COPE’s programmatic support has strengthened their validity and reputation with providers and clients, and has enhanced their ability to positively effect health outcomes among their clients. CHRs report an improved ability to deliver health coaching to their clients. Survey results show that 80. 2% of CHRs feel strongly positive that COPE trainings are useful, while 44.6% of CHRs felt that communication and teamwork had improved because of COPE., Conclusions: These findings suggest that CHRs have experienced positive benefits from COPE through training. COPE may provide a useful programmatic model on how best to support other Community Health Workers through strengthening clinic-community linkages, standardizing competencies and training support, and structuring home-based interventions for high-risk individuals.

Background: Navajo Nation Community Health Representatives (CHR) are trained community health workers (CHWs) who provide crucial services for patients and families. The success of the CHRs' interventions depends on the interactions between the CHRs and their clients. This research investigates the culturally specific factors that build and sustain the CHR-client interaction., Methods: In-depth interviews were conducted with 16 CHRs on Navajo Nation. Interviews were transcribed and coded according to relevant themes. Code summaries were organized into a narrative using grounded theory techniques., Results: The analysis revealed four findings critical to the development of a CHR-client relationship. Trust is essential to this relationship and provides a basis for providing quality services to the client. The ability to build and maintain trust is defined by tradition and culture. CHRs must be respectful of the diverse traditional and social practices. Lastly, the passing of clients brings together the CHR, the client's family, and the community., Conclusion: Understanding the cultural elements of the CHR-client relationship will inform the work of community partners, clinical providers, and other indigenous communities working to strengthen CHR programs and obtain positive health outcomes among marginalized communities.

Objective: To determine whether pharmacological treatment of depression in low-income minorities with diabetes improves A1C and quality of life (QOL)., Research Design and Methods: This was a 6-month, randomized, double-blind, placebo-controlled trial. Patients were screened for depression using Whooley's two-question tool at a county diabetes clinic. Depression was confirmed (or not) with the Computerized Diagnostic Interview Survey (CDIS) software program, and the severity of depression was assessed monthly by the Hamilton Depression Scale (HAM-D). Depressed subjects with A1C levels >or=8.0% were randomly assigned to receive either sertraline or placebo. Diabetes care was provided by nurses following detailed treatment algorithms who were unaware of therapy for depression., Results: A total of 150 subjects answered positively to at least one question on Whooley's questionnaire. The positive predictive value for depression diagnosed by CDIS was 69, 67, and 84% for positive answers to question 1 only, question 2 only, or both, respectively. Of the 89 subjects who entered the study, 75 completed. An intention-to-treat analysis revealed significant differences between baseline and 6 months in HAM-D and pain scores, QOL, and A1C and systolic blood pressure levels in both groups, with no differences between groups for the first three but a significantly greater decrease with sertraline in A1C and systolic blood pressure levels. Changes in HAM-D scores and A1C levels were significantly correlated in all subjects (P = 0.45 [P < 10(-6)])., Conclusions: In this low-income minority population, pharmacological treatment of depression significantly improved A1C and systolic blood pressure levels compared with placebo.

Evidence from four independent linkage studies and two meta-analyses of genome-wide data support the existence of a locus conferring susceptibility to inflammatory bowel diseases (IBD) in chromosomal region 19p. Identification of a susceptibility allele in this approximately 28.5 Mb region with over 600 genes is a formidable task. To tackle this problem, we undertook two approaches: (1) haplotype-based candidate-gene screen, and (2) evaluation of previously reported associations. For the former, we selected genes with potential implication in IBD pathogenesis based on published functional and expression data, typed SNPs, constructed haplotypes, screened for association in 180 IBD trios, and followed up preliminary associations in 343 IBD patients and 207 control individuals. Overall, we analyzed 465 SNPs, and 260 haplotypes distributed across 56 candidate genes. We found suggestive evidence of association (nominal P<0.01) with four genes (C3, FCER2, IL12RB1, and CRLF1) in a screening stage, but were unable to confirm these preliminary observations at follow-up. In the second approach, we typed four nonsynonymous polymorphisms in genes C3 (R102G and L314P) and ICAM1 (G241R and K469E) in four independent cohorts totaling 2178 IBD cases. We evaluated these data together with previously published reports for three of these variants (C3-Gly102, ICAM1-Arg241, and ICAM1-Glu469), in a meta-analysis. Our pooled meta-analysis provides compelling evidence against association of these variants with disease. Overall, we performed the most comprehensive candidate-gene association study for IBD to date. The information hereby generated constitutes a valuable resource to investigate other common genetic immune diseases, such as celiac disease.

The changes in serum total CPK and its isoenzymes have not been delineated in acute mesenteric infarction. As measurement of serum CPK levels could conceivably be a useful diagnostic test for bowel infarction, this experiment was performed to assess changes in serum CPK levels in bowel infarction in dogs, using sham operation and talc peritonitis as controls. Laparotomies were performed in 20 dogs, and each was as signed randomly to one of three groups: those having laparotomy (LAP), talc peritonitis (PER), and superior mesenteric artery infarction (MAI). Mixed venous blood samples were obtained from all subjects for 30 hours after surgery. All animals were killed, and complete autopsies were performed. Confirmation of infarction and determination of its extent were obtained through both gross and microscopic examination of the gut in canines subjected to arterial infarction. Total serum CPK levels were determined by spectrophotometric analysis. Agarose gel electrophoresis was used to determine the levels of each of the isoenzymes. Significant elevations of CPK and CPK-MM occurred nine hours after injury. CPK-BB reached maximum elevation by six hours, while CPK-MB did not reach its maximum until 24 hours after injury. From data in the study we conclude that total CPK and its isoenzymes become elevated in the serum of canines subjected to experimental superior mesenteric artery infarction. That CPK-BB elevations peak in the first 12 hours after injury and CPK-MB in the second 12 hours after injury may be of particular diagnostic significance.