Putting participants and study partners FIRST when clinical trials end early.

Between 2018 and 2019, multiple clinical trials ended earlier than planned, resulting in calls to improve communication with and support for participants and their study partners ("dyads"). The multidisciplinary Participant Follow-Up Improvement in Research Studies and Trials (Participant FIRST) Work Group met throughout 2021. Its goals were to identify best practices for communicating with and supporting dyads affected by early trial stoppage. The Participant FIRST Work Group identified 17 key recommendations spanning the pre-trial, mid-trial, and post-trial periods. These focus on prospectively allocating sufficient resources for orderly closeout; developing dyad-centered communication plans; helping dyads build and maintain support networks; and, if a trial stops, informing dyads rapidly. Participants and study partners invest time, effort, and hope in their research participation. The research community should take intentional steps toward better communicating with and supporting participants when clinical trials end early. The Participant FIRST recommendations are a practical guide for embarking on that journey.

Institutional Distrust among African Americans and Building Trustworthiness in the COVID-19 Response: Implications for Ethical Public Health Practice.

African Americans are disproportionately affected by COVID-19-related disease and mortality due to long-standing social, political, economic, and environmental injustice; and COVID-19 inequities are exacerbated by institutional distrust. In the absence of trust, public health authorities have not adequately fulfilled their professional and ethical obligations to protect African American communities from the negative effects of COVID-19. As institutional distrust is shaped by individual and collective experiences of untrustworthiness, we propose a paradigm shift from increasing trust among African Americans to increasing trustworthiness among medical and public health institutions/systems throughout the United States. This narrative review extends the literature describing how social determinants contribute to COVID-19 inequities by demonstrating how institutional distrust develops over time and is reinforced through systems of injustice. Additionally, we illustrate consequences of institutional distrust for COVID-19 inequities and provide recommendations for building trustworthiness through ethical public health practice.

Substance Use, General Health and Health Literacy as Predictors of Oral Health in Emerging Adult Sexual Minority Men of Color: A Secondary Data Analysis.

There is limited evidence surrounding oral health in emerging adult, sexual minority men of color. This study examined the association between sociodemographic factors, health literacy, cigarette, e-cigarette, and alcohol use on oral health outcomes. Secondary data analysis was conducted with 322 sexual minority men ages 18-34 in the United States. Between-group, mean-level, and multivariable logistic regression analyses examined differences on oral health outcomes. Increased cigarette (aOR = 1.84, p = 0.03), e-cigarette (aOR = 1.40, p = 0.03), and alcohol use (aOR = 2.07, p = 0.05) were associated with extended time away from the dentist. Health literacy (aOR = 0.93, p = 0.05) was negatively associated. Increased cigarette (aOR = 1.17, p = 0.04) and cigarette use (aOR = 1.26, p = 0.04) were associated with tooth loss. Health literacy was negatively associated (aOR = 0.65, p = 0.03). Increased e-cigarette (aOR = 1.74, p = 0.04) and cigarette use (aOR = 4.37, p < 0.001) were associated with dental affordability issues. Lower health literacy and racial identification as Black were associated with dental affordability issues; demonstrating an urgent need to address these factors to improve oral health in emerging adult sexual minority men of color.

Enhancing African American Participation in Biospecimens: A Case in Point for Pancreatic Cancer.

Diseases of the pancreas (i.e. chronic pancreatitis, diabetes, and pancreatic cancer) disproportionally affect the African American community. Challenges associated with engaging the African American community in biospecimen research are longstanding. We surveyed a number of pancreas-related biobanks, and data repositories for African American representation. While some of the biobanks and databases surveyed contain biospecimens and data from African American donors at levels that reflect minority representation among the general population, others do not. A number of factors have historically contributed to reduced participation of the African Americans community in biospecimen donation including medical mistrust, lack of transparency, fear, and a poor knowledge and understanding about the use of biospecimens for research. Suggestions for increasing African American participation in organ and biospecimen donation include educational interventions, particularly in community groups, and providing printed and online recruitment materials to patients, patient advocates, and care partners. Increasing awareness of the many benefits of biospecimen donation among African Americans will positively affect health disparities research into pancreatic cancer and other diseases.

Clinical Trials Participation Among African Americans and the Ethics of Trust: Leadership Perspectives.

Background: Assuring health equity throughout the U.S. continues to challenge the public and private research enterprise. Even with some progress, racial and ethnic health disparities continue, particularly among African Americans. Health equity for African Americans is improbable unless participation in clinical trials is measurably increased. Method: To inform efforts to enhance participation, interviews were conducted with three African American leadership groups from across the country to document their perceptions of why the research community is unable to engage African Americans effectively in clinical trials. The results of thirty-five interviews, conducted from three leadership groups, were analyzed and are reported in this article. The leadership groups include health/education, faith, and civic society. Ethical Considerations: This research was conducted based upon the ethical protocols of the National Center for Bioethics in Research and Health Care, research ethics, and confidentiality. Results: Findings indicate that trustworthiness must precede trust; both are essential in enhancing African American participation in research, especially in less understood clinical trials. Conclusion: Respondents agreed that the research community must demonstrate trustworthiness before trust can be established. They also indicated the importance of increasing the number of African American researchers in leadership roles. Also, suggestions were made regarding the need to develop short and long-term positive relationships between the research community and the African American population, at various levels, if increases in participation in clinical trials are expected. With the likely development of new clinical research and the attention to increasing excess deaths among African Americans, there must be representative numbers of African Americans and other underserved populations in leadership roles if health disparities are to be eliminated and health equity is to be achieved.

Individual Perspectives of Majority/Minority Partnerships: Who Really Benefits and How?

This study ascertained historically Black colleges and universities (HBCU) academic leaders' perceptions of equity between HBCU and predominantly White institutions (PWI) health professions school partnerships related to resource capacity, sustainability and scholarship. A focus group was conducted with seven HBCU health professions schools. A survey was sent to their PWI (n=14) partners. Four themes including positive and negative experiences, challenges, and recommendations to continue relationships with the PWIs were identified. Dissemination of the survey to PWIs resulted in no responses. Benefits of the partnerships include increased HBCU publications and PWI efforts to embrace HBCU students. Inequities in the distribution of social resources and of social justice include the fickle nature of partnership, little interest among PWIs in promoting HBCU expansion and independence, a lack of transparency and clarity in communications, and PWI claims of ownership for ideas proposed by the HBCU. Dual institutional appointments were also identified as problematic.

Ethics and Well-Being: Ages 45-64: 70 is the New 50.

The age range 45-64 covers a life-stage when ideally, health status is reasonably manageable. However, this life-stage also poses health risks, which may lead to diseases, illnesses, dysfunctions, disabilities and early death. In fact, over the last three years, life expectancy among non-Hispanic white men has decreased. The opportunity to synergize ethics, health and well-being at the individual and group/community level is also highlighted. Various sphere of ethics and how they impact on individual, group/community well-being strategically, infuses ethics into health and health care conversations. Difficult term to operationalize like well-being, health, ethics and healing are deliberated. The phrase "70 is the new 50" reflects an importance opportunity to discuss what it means to be middle age and be healthy. There are health threats created by social and environment injustices and food deserts which are important considerations influencing health. The concept of Optimal Health, as a group strategy to advance health, particularly for people of African descent, details five group domains: optimal physical, emotional, social-economic, intellectual, and spiritual health. Optimal Health translated into individual behavior also has five health promotion principles that are detailed in the article. Synergizing Optimal Health, at the group/community level, with the five Health Promotion Principles, at the individual level, is the ideal journey toward individual and group/community well-being. Persons ages 45-64 are poised to combine the wisdom gained from their lived experiences, with the knowledge acquired from their positive or negative interfaces with the health delivery system, are generously available to achieve Optimal Health. The article concludes by discussing the Ancient African Imhotep, True Father of Medicine, 2980 B.C.E.

Addressing Oral Health Disparities Via Educational Foci on Cultural Competence.

An ever-present challenge for the oral health profession is to reduce the extent of oral disease among racial and ethnic minority populations. Adding to this complex dilemma is the linkage between oral health and systemic health. We describe enhanced cultural competency, in the context of individual cultural beliefs, values, language, practice, and health behaviors, among dental professionals, as one approach to meeting the dental care needs of the underserved. An overview and examples of teaching methods used by University of Florida dental educators to enhance student cultural competency is provided. Evidence-based evaluation results provide evidence of methodology efficacy. We conclude by describing actions that can be implemented by academic dental institutions to facilitate development of culturally competent practitioners.

Examining the mediating role of cancer-related problems on spirituality and self-rated health among African American cancer survivors: a report from the American Cancer Society's Studies of Cancer Survivors-II.

OBJECTIVE: African American (AA) cancer survivors report poorer self-rated health (SRH) compared to other racial/ethnic groups. Spirituality is often linked to positive health outcomes, with AAs reporting greater levels of spirituality. This study examined the potential mediating role of cancer-related problems in the relationship between spirituality and SRH among AA cancer survivors compared to non-African American (non-AA) survivors. METHODS: We analyzed data on 9006 adult cancer survivors from the American Cancer Society's Study of Cancer Survivors-II. Preliminary analyses compared characteristics of AAs and non-AAs and identified significant covariates of SRH. We tested a path model using multi-group structural equation modeling (SEM), and then examined race as a moderator. RESULTS: Of the three domains of spirituality assessed, AAs had higher levels of peace (p < .001) and faith (p < .001), but not meaning, compared to non-AAs; and of four domains of cancer-related problems assessed, AAs had greater physical distress (p < .001), emotional distress (p < .001), and employment/finance problems (p < .001), but not fear of recurrence. In SEM analyses adjusting for number of comorbidities and income, race moderated the impact of spirituality and cancer-related problems on SRH. Specifically, spirituality had significantly stronger associations with cancer-related problems among AAs than non-AAs. Spirituality was positively associated with all four domains of cancer-related problems, but only physical distress was associated with SRH among AAs. CONCLUSIONS: The negative effects of physical distress may attenuate the positive effects of spirituality on AA's SRH. Future studies should consider racial/ethnic differences in the determinants and conceptualization of SRH, which is a known predictor of survival.