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.

A Framework for Using eHealth Interventions to Overcome Medical Mistrust Among Sexual Minority Men of Color Living with Chronic Conditions.

The purpose of this paper is to present a stepwise, multi-construct, innovative framework that supports the use of eHealth technology to reach sexual minority populations of color to establish trustworthiness and build trust. The salience of eHealth interventions can be leveraged to minimize the existing paradigm of medical mistrust among sexual minority populations of color living with chronic illnesses. These interventions include virtual environments and avatar-led eHealth videos, which address psychosocial and structural-level challenges related to mistrust. Our proposed framework addresses how eHealth interventions enable technology adoption and usage, anonymity, co-presence, self-disclosure, and social support and establish trustworthiness and build trust.

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.

Limited Evidence of Shared Decision Making for Prostate Cancer Screening in Audio-Recorded Primary Care Visits Among Black Men and their Healthcare Providers.

Prostate-specific antigen (PSA)-based prostate cancer screening is a preference-sensitive decision for which experts recommend a shared decision making (SDM) approach. This study aimed to examine PSA screening SDM in primary care. Methods included qualitative analysis of audio-recorded patient-provider interactions supplemented by quantitative description. Participants included 5 clinic providers and 13 patients who were: (1) 40-69 years old, (2) Black, (3) male, and (4) attending clinic for routine primary care. Main measures were SDM element themes and "observing patient involvement in decision making" (OPTION) scoring. Some discussions addressed advantages, disadvantages, and/or scientific uncertainty of screening, however, few patients received all SDM elements. Nearly all providers recommended screening, however, only 3 patients were directly asked about screening preferences. Few patients were asked about prostate cancer knowledge (2), urological symptoms (3), or family history (6). Most providers discussed disadvantages (80%) and advantages (80%) of PSA screening. Average OPTION score was 25/100 (range 0-67) per provider. Our study found limited SDM during PSA screening consultations. The counseling that did take place utilized components of SDM but inconsistently and incompletely. We must improve SDM for PSA screening for diverse patient populations to promote health equity. This study highlights the need to improve SDM for PSA screening.

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.

Clinical Trial Protocol for a Randomized Trial of Community Health Worker-led Decision Coaching to Promote Shared Decision-making on Prostate Cancer Screening Among Black Male Patients and Their Providers.

We propose a randomized controlled trial to evaluate the effectiveness of a community health worker-led decision-coaching program to facilitate shared decision-making for prostate cancer screening decisions by Black men at a primary care federally qualified health center.

Randomized trial of community health worker-led decision coaching to promote shared decision-making for prostate cancer screening among Black male patients and their providers.

BACKGROUND: Black men are disproportionately affected by prostate cancer, the most common non-cutaneous malignancy among men in the USA. The United States Preventive Services Task Force (USPSTF) encourages prostate-specific antigen (PSA) testing decisions to be based on shared decision-making (SDM) clinician professional judgment, and patient preferences. However, evidence suggests that SDM is underutilized in clinical practice, especially among the most vulnerable patients. The purpose of this study is to evaluate the efficacy of a community health worker (CHW)-led decision-coaching program to facilitate SDM for prostate cancer screening among Black men in the primary care setting, with the ultimate aim of improving/optimizing decision quality. METHODS: We proposed a CHW-led decision-coaching program to facilitate SDM for prostate cancer screening discussions in Black men at a primary care FQHC. This study enrolled Black men who were patients at the participating clinical site and up to 15 providers who cared for them. We estimated to recruit 228 participants, ages 40-69 to be randomized to either (1) a decision aid along with decision coaching on PSA screening from a CHW or (2) receiving a decision aid along with CHW-led interaction on modifying dietary and lifestyle to serve as an attention control. The independent randomization process was implemented within each provider and we controlled for age by dividing patients into two strata: 40-54 years and 55-69 years. This sample size sufficiently powered the detection differences in the primary study outcomes: knowledge, indicative of decision quality, and differences in PSA screening rates. Primary outcome measures for patients will be decision quality and decision regarding whether to undergo PSA screening. Primary outcome measures for providers will be acceptability and feasibility of the intervention. We will examine how decision coaching about prostate cancer screening impact patient-provider communication. These outcomes will be analyzed quantitatively through objective, validated scales and qualitatively through semi-structured, in-depth interviews, and thematic analysis of clinical encounters. Through a conceptual model combining elements of the Preventative Health Care Model (PHM) and Informed Decision-Making Model, we hypothesize that the prostate cancer screening decision coaching intervention will result in a preference-congruent decision and decisional satisfaction. We also hypothesize that this intervention will improve physician satisfaction with counseling patients about prostate cancer screening. DISCUSSION: Decision coaching is an evidence-based approach to improve decision quality in many clinical contexts, but its efficacy is incompletely explored for PSA screening among Black men in primary care. Our proposal to evaluate a CHW-led decision-coaching program for PSA screening has high potential for scalability and public health impact. Our results will determine the efficacy, cost-effectiveness, and sustainability of a CHW intervention in a community clinic setting in order to inform subsequent widespread dissemination, a critical research area highlighted by USPSTF. TRIAL REGISTRATION: The trial was registered prospectively with the National Institute of Health registry ( www.clinicaltrials.gov ), registration number NCT03726320 , on October 31, 2018.

Complementary and alternative medical practice: self-care preferred vs. practitioner-based care among patients with asthma.

BACKGROUND: Interest in disease self-management has increased as the US population ages, as health care costs skyrocket, and as more evidence is gathered on the etiologic basis of most chronic diseases. This study uses National Health Interview Survey (NHIS) data to analyze the association between asthma episode during the past 12 months and patterns of complementary and alternative medicine (CAM) use within the same period among adults, controlling for comorbid conditions. METHODS: Using questions taken from the adult sample questionnaire and the Alternative Supplement of the 2002 NHIS, responses of those ever having asthma (N=3327) were analyzed in this cross-sectional, correlational study. The chi2 test of independence was used to examine the relationships between experiencing an asthma episode in the past year, coexisting comorbidity, and the use of self-care based CAM compared to practitioner-based CAM. RESULTS: Overall CAM use differed significantly by asthma status, with 49% of those with asthma episodes using CAM compared with 42% of those who did not have an episode in the past year. Self-care based therapies were more likely to be used than practitioner-based therapies by individuals with single comorbid condition compared to those with 2 or more comorbidities. CONCLUSION: Although this study supports previous work indicating that disease severity--in this instance, asthma within the past year--is significantly associated with CAM use, it did not support studies showing greater CAM use in the presence of a greater number of comorbidities, suggesting that disease burden is a limiting factor when it comes to self-care based CAM use.

The African American Petri Dish.

This commentary amplifies the insidious nature of the novel coronavirus (resulting in COVID19) and its ubiquitous spread, which disproportionately and adversely affect the health and well-being of people of color. The consequence is poor health outcomes and premature death. Ample previous literature documents health inequities in the morbidity and mortality statistics for Black and Brown people in the United States. Their excess deaths are due to disproportionately high rates of serious health conditions (diabetes; hypertension; asthma; and lung, kidney, and heart disease), as well as structural factors having to do with income, employment, and the built environment in which they live. The health conditions are exacerbated with ongoing societal problems and stress emerging from the country's history of dehumanizing racial inequities. Current discrimination comes most virulently in the form of systematic and institutionalized racist policies that keep racial and ethnic minorities marginalized and disempowered. Furthermore, people of color encounter the immediate external pressures of working away from home and using public transportation during the country's extraordinary ongoing lockdown, heightening the risk of exposure to the virus. Moreover, the same population is overrepresented in jails and prisons where social distancing is impossible. Any virulent virus without a vaccine is bound to become a human petri dish in which people of color in the U.S. today are caught. The war against the coronavirus for people of color is part and parcel of the war to eliminate historic inequities and to level the socioeconomic playing field. This article covers the racial/ethnic inequities in morbidity and mortality from COVID19 and the slow and untimely response by the federal government to address mediation of the spread of the virus. For people of color to transcend the coronavirus pandemic crisis there must be comprehensive access to COVID-19 testing and early, sustained, and affordable access to health care, including hospitalization. Such access will require national leadership, which seems to be in short supply.

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.

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.

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.