Research in the USA on COVID-19's long-term effects: measures needed to ensure black, indigenous and Latinx communities are not left behind.

The SARS-CoV-2 (COVID-19) pandemic continues to expose underlying inequities in healthcare for black, indigenous and Latinx communities in the USA. The gaps in equitable care for communities of colour transcend the diagnosis, treatment and vaccinations related to COVID-19. We are experiencing a continued gap across racial and socioeconomic lines for those who suffer prolonged effects of COVID-19, also known as 'Long COVID-19'. What we know about the treatment for Long COVID-19 so far is that it is complex, requires a multidisciplinary approach and there is still much research needed to fully understand the effects. In this paper, we discuss pragmatic considerations for including affected communities, relevant stakeholders, and leaders from communities of colour in the planning and implementation of Long COVID-19 research.

Pragmatic patient engagement in designing pragmatic oncology clinical trials.

Oncology trials are the cornerstone of effective and safe therapeutic discoveries. However, there is increasing demand for pragmatism and patient engagement in the design, implementation and dissemination of oncology trials. Many researchers are uncertain about making trials more practical and even less knowledgeable about how to meaningfully engage patients without compromising scientific rigor to meet regulatory requirements. The present work provides practical guidance for addressing both pragmaticism and meaningful patient engagement. Applying evidence-based approaches like PRECIS-2-tool and the 10-Step Engagement Framework offer practical guidance to make future trials in oncology truly pragmatic and patient-centered. Consequently, such patient-centered trials have improved participation, faster recruitment and greater retention, and uptake of innovative technologies in community-based care.

The Family Value of Information, Community Support, and Experience Study: Rationale, Design, and Methods of a "Family-Centered" Research Study.

The Patient Protection and Affordable Care Act focuses on improving consumer engagement and patient-centered care. This article describes the design and rationale of a study targeting family engagement in pediatric mental health services. The study is a 90-day randomized trial of a telephone-delivered Family Navigator services versus usual care for parents of Medicaid-insured youth younger than 13 years with serious mental illness. Youth are identified through a pediatric antipsychotic medication preauthorization program. Family Navigators offer peer support to empower and engage parents in their child's recovery. Outcomes include parent report of empowerment, social support, satisfaction with child mental health services, and child functioning as well as claims-based measures of psychotherapy service utilization and antipsychotic medication dosage. The focus on "family-centered" care in this study is strongly supported by the active role of consumers in study design and implementation.

Community-Academic Partnerships for Health Research: An Iterative and Transparent Process of Patient Engagement Before the Research Begins.

Background: The root causes of coronavirus disease 2019 (COVID-19) disparities include longstanding systemic racial bias in economic advancement and care delivery, discrimination, lack of access, and social determinants of health. To address these causes, research institutions and health care systems must shift their lens from one that focuses solely on changing behaviors among underserved and vulnerable populations to one that is inward facing. Methods: We worked with a community advisory board and an African American church that has partnered on research for more than a decade to identify community norms, needs, and key resources needed for establishing community-academic partnerships for COVID-19 testing. Participants were purposefully sampled with equal representation from 3 groups: (1) church members and leaders, (2) academic or organization researchers with experience in community-engaged research, and (3) community members with experience participating in community-engaged research. Participants engaged in a hands-on exercise in the church basement as part of a town hall-style meeting. Results: Active discussion led to the identification of business model components salient to COVID-19 testing in an underserved Baltimore community, predominantly made up of African Americans. Our discussion identified key partners, activities, resources, costs, value propositions, community relationships, community groups, communication channels, and outputs for community buy-in. Conclusion: Developing the business case for mutual trustworthiness to be better prepared for future pandemics and public health crises may foster more sustainable community-academic partnerships. Using a Business Model Canvas, we delineate the major components, activities, and value propositions that are needed to achieve authentic community-academic partnerships to advance health equity.

Study protocol for transforming health equity research in integrated primary care: Antiracism as a disruptive innovation.

Among the consequences of systemic racism in health care are significant health disparities among Black/African American individuals with comorbid physical and mental health conditions. Despite decades of studies acknowledging health disparities based on race, significant change has not occurred. There are shockingly few evidence-based antiracism interventions. New paradigms are needed to intervene on, and not just document, racism in health care systems. We are developing a transformative paradigm for new antiracism interventions for primary care settings that integrate mental and physical health care. The paradigm is the first of its kind to integrate community-based participatory research and systems science, within an established model of early phase translation to rigorously define new antiracism interventions. This protocol will use a novel application of systems sciences by combining the qualitative systems sciences methods (group model building; GMB) with quantitative methods (simulation modeling) to develop a comprehensive and community-engaged view of both the drivers of racism and the potential impact of antiracism interventions. Community participants from two integrated primary health care systems will engage in group GMB workshops with researchers to 1) Describe and map the complex dynamic systems driving racism in health care practices, 2) Identify leverage points for disruptive antiracism interventions, policies and practices, and 3) Review and prioritize a list of possible intervention strategies. Advisory committees will provide feedback on the design of GMB procedures, screen potential intervention components for impact, feasibility, and acceptability, and identify gaps for further exploration. Simulation models will be generated based on contextual factors and provider/patient characteristics. Using Item Response Theory, we will initiate the process of developing core measures for assessing the effectiveness of interventions at the organizational-systems and provider levels to be tested under a variety of conditions. While we focus on Black/African Americans, we hope that the resulting transformative paradigm can be applied to improve health equity among other marginalized groups.

University of Maryland School of Medicine increases medical student education in primary care.

In August 2012 the University of Maryland School of Medicine will start a new Primary Care Track for incoming first year medical students as a collaborative program of the departments of Family and Community Medicine, Internal Medicine, and Pediatrics. Its focus will be to introduce all students to primary care role models early in medical school, and to offer a longitudinal experience in primary care in rural and urban underserved communities to interested students, with the intention of increasing the number of UMD medical students who choose primary care careers in these communities.

Tobacco smoke exposure in either the donor or recipient before transplantation accelerates cardiac allograft rejection, vascular inflammation, and graft loss.

BACKGROUND: Tobacco exposure in cardiac transplant recipients, before and after transplantation, may increase the risk of cardiac allograft vasculopathy and allograft loss, but no direct evidence for this phenomenon is forthcoming. In this experimental study, we investigated early consequences of tobacco smoke exposure in cardiac transplant donors and recipients with an emphasis on alloinflammatory mediators of graft outcome. METHODS AND RESULTS: Using heterotopic rat cardiac transplantation, we tested the effects of donor or recipient tobacco smoke exposure in 6 groups of animals (rat heterotopic cardiac transplantation) as follows: tobacco-naïve allogeneic rejecting controls (n=6), tobacco-naïve nonrejecting controls (n=3; killed on day 5 to simulate survival times of tobacco-treated animals), isografts (n=3), both donor and recipient rats exposed to tobacco smoke (n=4), only donor rats exposed to tobacco smoke (n=7), and only recipient rats exposed to tobacco smoke (n=6). Polymerase chain reaction studies of tissue and peripheral (systemic) protein expression were performed to evaluate inflammatory (tumor necrosis factor-alpha, interferon-gamma, interleukin-6) and alloimmune (interleukin-1 receptor 2, programmed cell death-1, and stromal cell-derived factor-1) pathways, as was histological analysis of the cardiac allografts. Our experiments reveal that pretransplantation tobacco exposure in donors and/or recipients results in heightened systemic inflammation and increased oxidative stress, reduces posttransplantation cardiac allograft survival by 33% to 57%, and increases intragraft inflammation (tumor necrosis factor-alpha, interferon-gamma, interleukin-6) and alloimmune activation (CD3, interleukin-1 receptor 2, programmed cell death-1, and stromal cell-derived factor-1) with consequent myocardial and vascular destruction. CONCLUSIONS: These sentinel findings confirm that tobacco smoke exposure in either donors or recipients leads to accelerated allograft rejection, vascular inflammation, and graft loss. Molecular pathways that intersect as arbiters in this phenomenon include instigation of alloimmune activation associated with tobacco smoke-induced inflammation.

Lessons Learned from the Medical University of South Carolina Transdisciplinary Collaborative Center (TCC) in Precision Medicine and Minority Men's Health.

The Transdisciplinary Collaborative Center (TCC) in Precision Medicine for Minority Men's Health was established at the Medical University of South Carolina (MUSC) in 2015 to address disparities in the translation of precision medicine approaches among racial minority groups. This regional consortium focuses on three primary areas: (1) the development of a consortium of regional and national partners, (2) conducting transdisciplinary research examining synergistic effects of biological, social, physiological, and clinical determinants of chronic disease risks and outcomes, and (3) dissemination and implementation of precision medicine approaches, with an emphasis on reducing disparities in health care and outcomes among minority men. Given consistent calls to better translate precision medicine approaches and the focus of this consortium on addressing disparities among minority men, we provide an overview of our experience in developing the MUSC TCC, including barriers and facilitators to conducting translational research on minority men's health issues in the context of precision medicine. Lessons learned and areas for improvement include providing enough time to create consistent partnerships and community engagement to improve recruitment and retention, identifying unique ways to engage diverse partners from across the region and nation, and better approaches to dissemination and communication for large partnerships focusing on precision medicine.

A descriptive analysis of state legislation and policy addressing clinical trials participation.

OBJECTIVES: This report describes state policy and legislation related to clinical trials participation and Maryland's model to enhance clinical trial availability and participation. METHODS: Descriptive review of state policy and legislation related to coverage for clinical trials costs based on data from the National Cancer Institute (NCI) State Cancer Legislative Database, the American Cancer Society, and NCI; additionally, discussion of Maryland's comprehensive multilevel clinical trial model comprising policy initiatives, community engagement, research, education, and infrastructure support. RESULTS: Twenty-four states have mandated clinical trial coverage through specific legislation or agreements since 1994. Covered benefits varied among the states. CONCLUSIONS: Besides cost and insurance barriers, there is a need to address important patient, physician and researcher, and structural barriers to clinical trial participation. Maryland provides a comprehensive model to address the multi-faceted clinical trial participation determinants as it tracks state and federal policy, documents trial barriers, and conducts community education.

Increasing pap smear utilization among Samoan women: results from a community based participatory randomized trial.

BACKGROUND: We tested the effectiveness of a theory-guided, culturally tailored cervical cancer education program designed to increase Pap smear use among Samoan women residing in the U.S. Territory of American Samoa. METHODS: We used a two-group, pretest-posttest design. The sample comprised 398 Samoan women age 20 and older recruited from Samoan churches. Women in the intervention group received a culturally tailored cervical cancer education program in three weekly sessions. The primary outcome was self-reported receipt of a Pap smear. RESULTS: Overall, there was a significant intervention effect, with intervention compared with control group women twice (adjusted odds ratio = 2.0, 95% confidence interval = 1.3-3.2, p < .01) as likely to self-report Pap smear use at the posttest. CONCLUSIONS: The findings support the efficacy of the multifaceted, theory-guided, culturally tailored community-based participatory cervical cancer education program for Samoan women in effecting positive changes in Pap smear use and cervical cancer related knowledge and attitudes.

Analysis of Maryland cancer patient participation in National Cancer Institute-supported cancer treatment clinical trials.

PURPOSE: We examined the relationship of sociodemographic factors, urban/rural residence, and county-level socioeconomic factors on accrual of Maryland patients with cancer to National Cancer Institute (NCI)-sponsored cancer treatment clinical trials. PATIENTS AND METHODS: Data were analyzed for the period 1999 to 2002 for 2240 Maryland patients with cancer accrued onto NCI-sponsored treatment trials. The extent to which Maryland patients with cancer and patients residing in lower socioeconomic and/or rural areas were accrued to cancer trials and were representative of all patients with cancer in Maryland was determined. Data were obtained from several sources, including NCI's Cancer Therapy Evaluation Program for Maryland patients with cancer in Cooperative Group therapeutic trials, Maryland Cancer Registry data on cancer incidence, and United States Census and the Department of Agriculture. RESULTS: For Maryland patients with cancer accrued onto NCI-sponsored treatment trials between 1999 and 2002, subgroups accrued at a higher rate included pediatric and adolescent age groups, white patients, female patients (for sex-specific tumors), patients with private health insurance, and patients residing in the Maryland National Capitol region. Moreover, between 1999 and 2002, there was an estimated annual decline (8.9% per year; P < .05) in the percentage of black patients accrued onto cancer treatment trials. Logistic regression models uncovered different patterns of accrual for female patients and male patients on county-level socioeconomic factors. CONCLUSION: Results highlight disparities in the accrual of Maryland patients with cancer onto NCI-sponsored treatment trials based on patient age, race/ethnicity, geography of residence, and county-level socioeconomic factors. Findings provide the basis for development of innovative tailored and targeted educational efforts to improve trial accrual, particularly for the underserved.

Needs and preferences for receiving mental health information in an African American focus group sample.

The purpose of this study is to better understand the mental health/illness information and service delivery preferences among African American residents of Baltimore. We conducted four focus groups (n = 42) among African American adults currently unconnected with the mental health system. Participants expressed fear of stigma and perceptions of racism as major barriers to seeking information and/or services and discussed some normalizing strategies to address these barriers. African Americans harbor cultural and traditional beliefs regarding mental illness which could also act as barriers. Findings have implications for imparting acceptable and culturally sensitive mental health education and service delivery programs in community settings.

Breast cancer epidemiology in blacks and whites: disparities in incidence, mortality, survival rates and histology.

BACKGROUND: This study presents black-white breast cancer statistics, tumor histology and receptor status, and treatment patterns for all ages and by age groups (< 40, 40-49, and > or = 50). METHODS: The study used data from the National Cancer Institute (NCI) Surveillance, Epidemiology and End Results (SEER) program for the time period 1995-2004. Age-adjusted incidence, mortality, relative survival rates, tumor grade, histology and receptor status, and treatment patterns for invasive breast cancer were calculated for nine SEER cancer registries for 1995-2004. RESULTS: Invasive breast cancer age-adjusted incidence for black women age < 40 was significantly higher than those for white women (rate ratio = 1.16, 95% confidence interval: 1.10-1.23). Age-adjusted mortality rate for black women age < 40 was twice that for white women. Compared to white women, black women were significantly more likely to be diagnosed with regional or distant disease, have lower relative five-year survival rate and have higher likelihood of being diagnosed with tumors with poorer prognosis. Black women were less likely to receive breast cancer surgery as part of the treatment plan. CONCLUSIONS: Race/ethnic disparities in invasive breast cancer epidemiology, prognostic indicators and treatment patterns exist between black and white women. The study findings support the need for innovative research, especially on the multifaceted determinants of the differential epidemiology of breast cancer. Equally important, there is a need for evidence-guided equal delivery of quality care to eliminate breast cancer disparities among black women.

A randomized trial comparing web-based decision aids on prostate cancer knowledge for African-American men.

OBJECTIVES: Few decision aids are tailored for African-American men. We sought to determine if web-based decision aids increased knowledge of prostate cancer screening among African men. METHODS: This postintervention, quasiexperimental research measured knowledge of prostate cancer screening among African-American men following receipt of 1 of 2 web-based decision aids: enhanced or usual care. Men ages 40-65 were recruited at the annual convention of the Prince Hall Masons in the summer of 2007, which was attended by 1170 masons. The primary outcome was knowledge of prostate cancer screening. RESULTS: There were 87 participants in the sample with a mean age of 52 years (standard deviation = 6.9). Forty-six masons were randomized to the enhanced decision aid, and 41 masons were randomized to the usual care decision aid. Knowledge scores were statistically significantly higher among the men receiving the enhanced decision aid compared to the usual care decision aid after simultaneously adjusting for age, educational level, marital status, family history, previous prostate specific antigen test and digital rectal exam (p = 0.01). CONCLUSION: We found evidence that the enhanced web decision aid was significantly more effective than the usual care decision aid in promoting knowledge of the benefits, limitations and risks of prostate cancer screening. Web-based sites may be effective in facilitating discussions about screening between patients and health care providers.

Clinical trials: the art of enrollment.

OBJECTIVES: Enrollment barriers and multidisciplinary approaches to increase cancer trials participation are presented. Recruitment barriers, research in Maryland, and a Best Practice for cancer trials are discussed. DATA SOURCES: Journal and research articles, web sites. CONCLUSION: Clinical trials have produced prevention and care advances for cancer and other diseases. Trial enrollment is lower for minorities and underserved communities. A comprehensive program for addressing enrollment barriers should incorporate research on barriers, multidisciplinary teams, and education and trial infrastructure in community settings. IMPLICATIONS FOR NURSING PRACTICE: Health disparities training, including culturally appropriate enrollment approaches for education and retention of underserved communities, should incorporate community stakeholders and nurse/physician researchers.

Outcomes from a comprehensive stroke telemedicine program.

Our team has studied the use of telemedicine to overcome obstacles to providing acute stroke care and expanding stroke education. We report a summary of our outcomes to provide evidence supporting greater development of stroke telehealth systems. Stroke telemedicine is audio-video communication (teleconferencing) between a stroke specialist and a remote party requiring stroke services. Using several models, we tested the validity, reliability, and effectiveness of telemedicine versus telephone consultations and face-to-face (traditional) medical care and education. Because of the challenges inherent to technology studies, we found a prospective, case control design most practical for testing hypotheses related to a comparison of telemedicine and traditional service delivery. Telemedicine-assisted neurologic evaluation and stroke diagnosis were as valid and reliable as traditionally delivered services. Clinical effectiveness was demonstrated by shortening times to treatment (17 [telemedicine] vs. 33 [control] minutes; p = 0.003) and increasing tissue plasminogen activator use at a remote hospital (from 5% to 24%). Evaluation of telemedicine as a means to expand stroke education to distant communities revealed that telemedicine and direct education achieve equivalent academic results. Stroke services delivered by telemedicine are safe, efficacious, and comparable to those rendered face-to-face. Telemedicine is a means of providing disability-reducing therapies earlier to a large number of patients. The current, geographically defined scheme for telemedicine service reimbursement fails to recognize that the main barrier to stroke care is lack of available stroke specialists. Contractual and third-party reimbursement structures should be modified to surmount this impediment to extending stroke specialty care and community education.

Results of a randomized trial to increase mammogram usage among Samoan women.

BACKGROUND: There are no effective breast cancer education programs targeting Samoan women. We tested the effectiveness of a theory-guided, culturally appropriate breast cancer education program (the intervention) designed to increase mammography use among Samoan women. METHODS: This community-based participatory cluster-randomized controlled intervention trial used a parallel two-group design. The sample consisted of 776 women aged 42 and older who had not had a mammogram in the preceding 2 years. The primary outcome was self-reported mammogram use between pretest and posttest. RESULTS: Overall, there was no statistically significant intervention effect, although the odds of self-reported mammogram use were higher in the intervention than the control group (odds ratio (OR), 1.26; 95% confidence interval (95% CI), 0.74, 2.14; P = 0.39). Exploratory subgroup analyses found that the intervention was effective only among women who were aware of mammograms but had never previously obtained one (OR, 1.99; 95% CI, 1.03, 3.85; P = 0.04). Low need for social support and lack of endorsement of culture-specific beliefs about breast cancer were associated with mammogram use in this group. In women unaware of mammography at pretest, high perceived susceptibility to breast cancer and endorsement of culture-specific beliefs were associated with mammogram use. For women who had previously obtained a mammogram, lower self-efficacy was associated with mammogram use. Intervention compared with control group women had significantly higher levels of knowledge of risk factors and lower endorsement of culture-specific beliefs at posttest. CONCLUSIONS: Results suggest that a multifaceted education intervention may improve mammogram usage for certain subgroups of Samoan women.

An unsupervised approach to identify molecular phenotypic components influencing breast cancer features.

To discover a biological basis for clinical subgroupings within breast cancers, we applied principal components (PCs) analysis to cDNA microarray data from 36 breast cancers. We correlated the resulting PCs with clinical features. The 35 PCs discovered were ranked in order of their impact on gene expression patterns. Interestingly, PC 7 identified a unique subgroup consisting of estrogen receptor (ER); (+) African-American patients. This group exhibited global molecular phenotypes significantly different from both ER (-) African-American women and ER (+) or ER (-) Caucasian women (P < 0.001). Additional significant PCs included PC 4, correlating with lymph node metastasis (P = 0.04), and PC 10, with tumor stage (stage 2 versus stage 3; P = 0.007). These results provide a molecular phenotypic basis for the existence of a biologically unique subgroup comprising ER (+) breast cancers from African-American patients. Moreover, these findings illustrate the potential of PCs analysis to detect molecular phenotypic bases for relevant clinical or biological features of human tumors in general.

Health disparities: a barrier to high-quality care.

PURPOSE: Disparities in the treatment of cardiovascular disease, diabetes mellitus, and cancer among the sexes and racial groups and possible interventions are discussed. SUMMARY: The ongoing process to identify and reduce health disparities has engaged numerous federal agencies as they monitor the nation's progress toward policy-driven and health-related objectives. Cardiovascular disease disproportionately affects minority groups and is the leading cause of death among women in the United States, and both groups receive suboptimal care for the disease. Disparities in the treatment of diabetes mellitus in African Americans, women, patients with less than a high school education, and the elderly have been found. Many minority groups continue to suffer disproportionately from cancer. Racial disparities also exist in cancer screening and treatment. Minorities are underrepresented in clinical trials for multiple reasons, many of which may be related to cultural beliefs. At all levels of coinsurance, the poor are less likely to seek preventive care. Adherence to national screening and treatment guidelines, clinical trial recruitment and participation, addressing language and geographic barriers, and increasing access to insurance are part of the coordinated efforts required to reduce health disparities. Because pharmacists influence patients' health status directly through pharmaceutical care and indirectly by engaging patients in their treatment, it is essential for pharmacists to be able to provide culturally competent care. CONCLUSION: Despite significant efforts over the past several years, health disparities continue to exist, particularly among minority groups. Interventions aimed at eliminating these disparities should include ensuring cultural competence among health care providers and improving health literacy among patients.

Esophageal cancer epidemiology in blacks and whites: racial and gender disparities in incidence, mortality, survival rates and histology.

BACKGROUND: Esophageal cancer rate disparities are pronounced for blacks and whites. This study presents black-white esophageal cancer incidence, mortality, relative survival rates, histology and trends for two five-year time periods--1991-1995 and 1996-2000--and for the time period 1991-2000. METHODS: The study used data from the National Cancer Institute's population-based Surveillance Epidemiology End Results (SEER) program with submission dates 1991-2000. Age-adjusted incidence, mortality, relative survival rates and histology for esophageal carcinoma were calculated for nine SEER cancer registries for 1991-2000. Rates were analyzed by race and gender for changes over specified time periods. RESULTS: Esophageal cancer age-adjusted incidence of blacks was about twice that of whites (8.63 vs. 4.39/100,000, p < 0.05). Age-adjusted mortality for blacks, although showing a declining trend, was nearly twice that of whites (7.79 vs. 3.96, p < 0.05). Although survival was poor for all groups, it was significantly poorer in blacks than in whites. Squamous cell carcinoma was more commonly diagnosed in blacks and white females, whereas adenocarcinoma was more common among white males (p < 0.001). CONCLUSIONS: Racial disparities in esophageal cancer incidence, mortality, survival and histology exist. Survival rates from this disease have not significantly improved over the decade. These data support the need for advances in prevention, early detection biomarker research and research on new, more effective treatment modalities for this disease.