Health Equity in Patients Receiving Durvalumab for Unresectable Stage III Non-Small Cell Lung Cancer in the US Veterans Health Administration.

BACKGROUND: Real-world evidence is limited regarding the relationship between race and use of durvalumab, an immunotherapy approved for use in adults with unresectable stage III non-small cell lung cancer (NSCLC) post-chemoradiotherapy (CRT). This study aimed to evaluate if durvalumab treatment patterns differed by race in patients with unresectable stage III NSCLC in a Veterans Health Administration (VHA) population. MATERIALS AND METHODS: This was a retrospective analysis of White and Black adults with unresectable stage III NSCLC treated with durvalumab presenting to any VHA facility in the US from January 1, 2017, to June 30, 2020. Data captured included baseline characteristics and durvalumab treatment patterns, including treatment initiation delay (TID), interruption (TI), and discontinuation (TD); defined as CRT completion to durvalumab initiation greater than 42 days, greater than 28 days between durvalumab infusions, and more than 28 days from the last durvalumab dose with no new durvalumab restarts, respectively. The number of doses, duration of therapy, and adverse events were also collected. RESULTS: A total of 924 patients were included in this study (White = 726; Black = 198). Race was not a significant factor in a multivariate logistic regression model for TID (OR, 1.39; 95% CI, 0.81-2.37), TI (OR, 1.58; 95% CI, 0.90-2.76), or TD (OR, 0.84; 95% CI, 0.50-1.38). There were also no significant differences in median (interquartile range [IQR]) number of doses (White: 15 [7-24], Black: 18 [7-25]; P = .25) or median (IQR) duration of therapy (White: 8.7 months [2.9-11.8], Black: 9.8 months [3.6-12.0]; P = .08), although Black patients were less likely to experience an immune-related adverse event (28% vs. 36%, P = .03) and less likely to experience pneumonitis (7% vs. 14%, P < .01). CONCLUSION: Race was not found to be linked with TID, TI, or TD in this real-world study of patients with unresectable stage III NSCLC treated with durvalumab at the VHA.

COVID-19 Vaccine Administration, by Race and Ethnicity - North Carolina, December 14, 2020-April 6, 2021.

COVID-19 has disproportionately affected non-Hispanic Black or African American (Black) and Hispanic persons in the United States (1,2). In North Carolina during January-September 2020, deaths from COVID-19 were 1.6 times higher among Black persons than among non-Hispanic White persons (3), and the rate of COVID-19 cases among Hispanic persons was 2.3 times higher than that among non-Hispanic persons (4). During December 14, 2020-April 6, 2021, the North Carolina Department of Health and Human Services (NCDHHS) monitored the proportion of Black and Hispanic persons* aged ≥16 years who received COVID-19 vaccinations, relative to the population proportions of these groups. On January 14, 2021, NCDHHS implemented a multipronged strategy to prioritize COVID-19 vaccinations among Black and Hispanic persons. This included mapping communities with larger population proportions of persons aged ≥65 years among these groups, increasing vaccine allocations to providers serving these communities, setting expectations that the share of vaccines administered to Black and Hispanic persons matched or exceeded population proportions, and facilitating community partnerships. From December 14, 2020-January 3, 2021 to March 29-April 6, 2021, the proportion of vaccines administered to Black persons increased from 9.2% to 18.7%, and the proportion administered to Hispanic persons increased from 3.9% to 9.9%, approaching the population proportion aged ≥16 years of these groups (22.3% and 8.0%, respectively). Vaccinating communities most affected by COVID-19 is a national priority (5). Public health officials could use U.S. Census tract-level mapping to guide vaccine allocation, promote shared accountability for equitable distribution of COVID-19 vaccines with vaccine providers through data sharing, and facilitate community partnerships to support vaccine access and promote equity in vaccine uptake.

Providing culturally sensitive diabetes self-management education and support for black African and Caribbean communities: a qualitative exploration of the challenges experienced by healthcare practitioners in inner London.

INTRODUCTION: Poor access to, and engagement with, diabetes healthcare is a significant issue for black British communities who are disproportionately burdened by type 2 diabetes (T2D). Tackling these inequalities is a healthcare priority. The purpose of this research was to explore the experiences of healthcare practitioners providing diabetes self-management education and support (DSMES) to African and Caribbean adults living with T2D to inform the development of a culturally tailored DSMES program. RESEARCH DESIGN AND METHODS: Semi-structured interviews were carried out with a range of healthcare practitioners including diabetes specialist nurses, dietitians and general practitioners based in primary care in inner London. Thematic content analysis was used to identify barriers and facilitators relating to the provision of effective DSMES. RESULTS: Ten interviews were conducted. There was a strong consensus among healthcare practitioners for the importance of DSMES in T2D healthcare. However, practitioners discussed this area of practice as overwhelmingly challenging and recognized a wide range of barriers that they face. Four themes were identified: (1) The tension between structural and responsive care needs, particularly with growing numbers of patients alongside incentivized targets driving a care agenda that does not meet the needs of diverse communities; (2) challenges posed by cultural beliefs and practices, particularly a distrust of conventional medicine, rejection of body mass index standards and a belief in 'God's will'; (3) building relationships through cultural understanding: insiders and outsiders, particularly the benefits of racial concordance and cultural knowledge/resources and (4) getting the messages across, particularly the need to address gaps in structured education. CONCLUSION: Provision of culturally sensitive DSMES is a challenging area of practice for practitioners, who recognize the need for more training and resources to support them in developing cultural competence. Nonetheless, practitioners recognize the importance of DSMES and are striving to provide culturally sensitive care to their patients.

Smartphone applications available to pregnant women in the United Kingdom: An assessment of nutritional information.

The importance of diet during pregnancy is critically important for the short- and long-term health of both mother and child. The number of apps targeting pregnant women is rapidly increasing, yet the nutritional content of these tools remains largely unexplored. This review aimed to evaluate the coverage and content of nutrition information in smartphone apps available to U.K. pregnant women. Keyword searches were conducted in iTunes and Google Play stores in November 2018. Candidate apps were included if they targeted pregnant women, provided pregnancy-specific nutritional information, had a user rating of at least 4+ based on at least 20 ratings, and were available in English. Nutritional content was assessed for accuracy against U.K. recommendations. Behaviour change techniques (BCTs) were also evaluated. Twenty-nine apps were included, seven of which originated in the United Kingdom. There was a large variability in the quality of smartphone app nutritional information. The accuracy of nutrition information varied, and several apps conveyed inappropriate information for pregnancy. On average, 10 BCTs were identified per app (range 2-15). Overall, smartphone apps do not consistently provide accurate and useful nutritional information to pregnant women. This study highlights the need for the integration of evidence-based nutritional information during app development and for increased regulatory oversight. App developers should also make it clear that nutritional content is intended for a specific geographical region or population or modify for the intended audience. These are important considerations for the design of future apps, which are increasingly used to complement existing maternity services.

Liver safety evaluation of endothelin receptor antagonists using HepatoPac® : A single model impact assessment on hepatocellular health, function and bile acid disposition.

Marketed (bosentan, ambrisentan) and discontinued (sitaxsentan, CI-1034) endothelin receptor antagonists were examined in the human micropatterned hepatocyte co-culture (MPCC) model HepatoPac® . Differences across hepatocellular health (cellular adenosine triphosphate/glutathione content), function (urea production/albumin secretion) and taurocholic acid transport (biliary clearance/excretion index) were compared using amiodarone and ciclosporin A as positive controls. Ambrisentan had the weakest potency in all six endpoints, while sitaxsentan, bosentan and CI-1034 had more potent effects on hepatobiliary transport than health/function endpoints. Normalization to clinical Cmax gave the following relative rank order of safety based on margins for each endpoint: ambrisentan ≥ CI-1034 ~ bosentan > sitaxsentan. These data suggested impaired hepatobiliary disposition might contribute to a more prominent role in liver injury associated within sensitive human populations exposed to these compounds than direct hepatocellular toxicity. Rat, dog and monkey MPCCs also showed greater sensitivity potential to disrupted hepatobiliary disposition compared with hepatocellular health/functional endpoints. Drug metabolism competency was exhibited across all species. In vivo, rats and dogs appear more resistant to transaminase elevations and/or histological evidence of liver injury caused by these mechanisms even at exceedingly high systemic exposures relative to sensitive humans. Rats and dogs are resistant to hepatobiliary toxicants due to physiological differences in bile composition/handling. Although traditional animal testing provides adequate safety coverage for advancement of novel pharmaceuticals into clinical trials, supplemental assays employing human MPCCs may strengthen weight-of-evidence predictions for sensitive human populations. Proving the predictive value of this single impact assessment model in advance of clinical trial information for human liver injury risk is needed across more pharmaceuticals.

Use of dietary assessment tools in randomized trials evaluating diet-based interventions in pregnancy: a systematic review of literature.

PURPOSE OF REVIEW: Accurate assessment of dietary intake in interventional trials is the key to evaluate changes in dietary behaviour and compliance. We evaluated the use of dietary assessment tools in randomized trials on diet-based interventions in pregnancy by a systematic review. RECENT FINDINGS: We updated our previous search (until January 2012) on trials of diet and lifestyle interventions in pregnancy using Medline and EMBASE up to December 2015. Two independent reviewers undertook study selection and data extraction. We assessed the characteristics of dietary assessment tools, the timing and frequency of use and any validation undertaken.Two-thirds (39/58, 67%) of the included studies used some form of tools to assess dietary intake. Multiple days' food diaries were the most commonly used (23/39, 59%). Three studies (3/39, 8%) validated the used tools in a pregnant population. Three studies (3/39, 8%) prespecified the criteria for adherence to the intervention. The use of dietary assessment tools was not associated with study quality, year of publication, journal impact factor, type of journal and the study sample size. SUMMARY: Although self-reporting dietary assessment tools are widely used in interventional dietary trials in pregnancy, the quality and applicability of existing tools are low.

A micropatterned hepatocyte coculture model for assessment of liver toxicity using high-content imaging analysis.

The current landscape of in vitro models used to identify drug- or chemical-induced hepatotoxicity relies heavily on cell culture models consisting of HepG2, induced pluripotent stem cell-derived, or primary hepatocytes. While these in vitro models offer powerful approaches for predicting toxicity, each system has challenges, including variable metabolic capacity, brief ex vivo life span in culture, and adoption with standard automated microscopy high-content screening (HCS) systems to measure reproducibility data at the single-cell level. In this report we introduce a novel primary hepatocyte coculture model, HepatoPac™, as an alternative to current model systems for evaluation of in vitro hepatotoxicity in 96-well microtiter plate format examined by HCS. The coculture model consists of primary hepatocytes that are micropatterned to form a discrete microarchitecture or "hepatocyte islands" that are surrounded by supporting fibroblasts resulting in long-term viability and metabolic function of primary hepatocytes. Using multiple HCS image capture and image analysis strategies, we established methods to interrogate various morphometric parameters, such as size, shape, and intensity, at the island or single-cell level. We applied these approaches to identify subpopulations of both fibroblasts and hepatocytes that exhibited alterations in nuclear parameters, cell permeability, mitochondria function, and apoptosis using known reference control compounds and an eight-point dose curve. Subpopulation analysis with additional bioprobe sets can provide a powerful means of addressing differential cell and tissue susceptibilities during compound profiling. Our data show that the HepatoPac is amendable for HCS imaging applications and provides a unique approach for studying hepatotoxicity over prolonged periods of time.

Influence of weaning timing advice and associated weaning behaviours in a survey of black and minority ethnic groups in the UK.

OBJECTIVE: To assess understanding of the Department of Health weaning guidelines and weaning influences in a self-selected sample of black and minority ethnic (BME) parents, residing in London. DESIGN: A face-to-face, questionnaire-facilitated survey among Black African, Black Caribbean and South Asian parents. SETTING: An opportunistic sample of parents was recruited from Sure Start centres, churches and play groups across key London boroughs. SUBJECTS: Three hundred and forty-nine interviews were included; 107 Black African, fifty-four Black Caribbean, 120 South Asian and sixty-four of Black mixed-race ethnicity. RESULTS: Fifty-two per cent of Black and 66 % of South Asian parents had accurate understanding of the guidelines. Inaccurate knowledge of the guidelines was associated with weaning before 17 weeks (P < 0·001); 36 % of Black Africans and 31 % of Black Caribbeans were weaned before 4 months compared with 16 % of South Asians. All BME groups were most influenced by weaning information from the previous generations of mothers in their families, which was associated with earlier weaning (21·5 (SD 6·5) v. 24·1 (SD 4·2) weeks; F(2,328) = 5·79, P = 0·003), and less so by professional infant feeding advice, which was associated with a later weaning age (23·7 (SD 5·1) v. 20·7 (SD 5·7) weeks; F(1,344) = 34·7, P < 0·001). CONCLUSIONS: Lack of awareness of the Department of Health weaning guidelines is common among these BME populations, whose weaning behaviour is strongly influenced by informal advice. Further research is necessary to elucidate the influences on weaning in these populations and to facilitate the development of infant feeding support which is salient for BME groups in the UK.

An online survey of knowledge of the weaning guidelines, advice from health visitors and other factors that influence weaning timing in UK mothers.

The UK weaning guidelines recommend the introduction of solid food at or around 6 months. The evidence suggests that knowledge of the guidelines is high, although only a small minority of parents wait until 6 months to wean. The aim of this study was to assess understanding of the UK weaning guidelines in a sample of UK parents and investigate the associations of this understanding with weaning timing, and in comparison to other influencing factors. This study conducted an online survey of UK parents. Eligible participants had weaned a child since the introduction of the current guidelines. Of 3607 participants, 86% accurately understood the guidelines. Eighty-seven per cent of health visitors were reported to have advised weaning at or around 6 months. Knowledge of the guidelines was associated with later weaning (independently of demographic factors) (P < 0.001) but did not ensure compliance: 80% of mothers who weaned before 24 weeks and 65% who weaned before 17 weeks were aware of the guidelines. Younger mothers (P < 0.001), those receiving benefits (P < 0.001), those educated only to 16 (P < 0.001) and minority ethnic groups (P < 0.001) had lower levels of awareness. Poor understanding of the guidelines was the most reliable predictor of early weaning (P = 0.021) together with young maternal age (P = 0.014). Following the baby-led weaning approach was the most reliable predictor of those weaning at 26 weeks, together with the Internet being the most influential source of advice. Understanding of the current weaning guidelines is high and is a key independent predictor of weaning age in this population.

Sources of weaning advice, comparisons between formal and informal advice, and associations with weaning timing in a survey of UK first-time mothers.

OBJECTIVE: The aim of the present study was to explore knowledge of the UK weaning guidelines and the sources of weaning advice used by UK first-time mothers. DESIGN: An online survey of UK parents; analysed using mixed methods. SETTING: Participants were recruited from a selection of parenting websites that hosted a link to the survey. SUBJECTS: In total, 1348 UK first-time mothers were included in the analysis. RESULTS: Knowledge of the guidelines was high (86 %) and associated with later weaning (P < 0·001), although 43 % of this sample weaned before 24 weeks. The majority of parents used multiple sources of information, the most influential being the health visitor (26 %), the Internet (25 %) and books (18 %). Fifty-six per cent said they received conflicting advice. Younger mothers and those of lower educational attainment were more likely to be influenced by advice from family, which was likely to be to wean earlier. Furthermore, those most influenced by their mother/grandmother were less likely to have accurate knowledge of the guidelines. In this population the Internet was used for weaning advice across all sociodemographic groups and was associated with a later weaning age, independently of sociodemographic factors (P < 0·001). Data from responses to a free-text question are used in illustration. CONCLUSIONS: The study suggests that first-time mothers have a good understanding of the weaning guidelines but seek weaning information from multiple sources, much of which is conflicting. Informal sources of weaning advice appear most influential in younger mothers and those of lower educational attainment, and result in earlier weaning.

Recruiting research participants at community education sites.

BACKGROUND: Minority groups are underrepresented in research, making it difficult to apply medical advances with confidence. In this study, we explored whether community-based cancer education sites and educators serving the African American community could be used to recruit minority participants to research. METHODS: We invited Individuals at community education sites to provide buccal scrapings, saliva samples, psychometric data, and personal information anonymously. RESULTS: Culturally aligned community sites (100%) collaborated in the research recruitment, as did 83% of the individuals at those sites. CONCLUSION: Community-based education sites offer exceptional promise for teaching about research benefits and recruiting members of minority groups to research studies.