Non-white Participants Research Articles

Alcoholism and Risk of Lung Cancer in Observational Studies: A Systematic Review

ObjectivesHeavy drinking increases the risk of many chronic diseases. Alcoholics are those with an alcohol use disorder (AUD), characterized by excessive consumption of alcohol, alcohol abuse behavior and/or dependence. In addition, they often have micronutrient deficiencies due to poor diet, which increases their risk for lung cancer and other chronic diseases. Heavy drinking was reported to be a possible risk factor for lung cancer, although smokers also tend to be drinkers. Given that previous reviews often included alcoholics, not clinically diagnosed, we conducted a systematic review to summarize the current evidence on associations of clinically diagnosed AUD with risk of lung cancer incidence or mortality reported in observational studies.MethodsFirst, in January of 2022, we conducted a systematic literature review via PubMed using the search terms: alcoholism, lung cancer, and risk or morbidity or mortality. The search was limited to human studies published in English from 2000 to present. The inclusion criteria were original observational studies with clinical diagnoses of AUD or treatment for alcoholism and lung cancer incidence or mortality in a non-lung cancer population. Second, we selected original studies included in a previous meta-analysis of alcoholics and lung cancer by Korte et al. published in 2002 that met the inclusion criteria.ResultsA total of 1250 articles were retrieved via PubMed, of which three met the inclusion criteria. From the Korte's meta-analysis, six out of eleven articles met inclusion criteria. These nine articles included a total of 3,050 lung cancer cases with over 234,715 participants (mostly white males) from nine studies conducted in 1925–2012. For all studies, alcoholics had an increased risk of lung cancer compared to non-alcoholics by 2% to 300%, which were statistically significant in five studies. The majority did not adjust for smoking or other lifestyle factors.ConclusionsOverall, an increased risk of lung cancer was observed among those with AUD compared with those without AUD. These associations are complicated by smoking and poor diet, which most studies did not account for. Future research needs to consider these factors and include more non-white and female participants.Funding SourcesThis study was funded by the Summer Undergraduate Research Experience Science Program at Oregon State University.

Financial distress, health literacy, numeracy, and treatment receipt by race/ethnicity amongst breast cancer survivors.

e18554 Background: Low-income and minority women are less likely to receive breast cancer treatments and have higher mortality rates compared with other women.We examined economic hardship, health literacy, and numeracy by race/ethnicity and whether these factors were associated with differences in receipt of recommended treatment. Methods: We conducted a telephone survey in 2018-2020 of adult women diagnosed with stage I-III breast cancer between 2013-2016 at three centers in Boston and New York. We asked women about treatment receipt and factors contributing to decision-making. We used X2 and Fischer exact tests to examine associations between economic distress, health literacy/numeracy, and treatment receipt by race/ethnicity. Results: Among 326 respondents (AAPOR cooperation rate 63-80% across sites), 55% were Non-Hispanic (NH) White, 23% were NH Black, and 14% Hispanic; 15% were Medicaid-insured. Due to item non-response, sample sizes ranged from 294-315 per question. A substantial proportion of women, and particularly Black and Hispanic women, reported economic distress, worse finances over time, and low literacy/numeracy (Table). Overall, 7% (n = 22) did not initiate at least one recommended treatment. Although we observed no differences in treatment by race/ethnicity (p = 0.70), those not initiating recommended treatment(s) reported more worry about paying large medical bills (52% vs. 27%) and covering visit costs (27 vs. 10%); p < .05 for both. Conclusions: In a diverse sample of breast cancer survivors, financial distress was common, particularly for non-White participants; non-White women also had lower literacy/numeracy. Although we observed some associations of these factors (but not race/ethnicity) with less receipt of recommended treatments, because few women declined treatments, understanding the scope of impact is limited. However, our results highlight the importance of up-front and longer-term assessments of resource needs and allocation of support for breast cancer survivors. Novelty of this work includes the granular measures on financial distress and the focus on health literacy/numeracy among a diverse population.[Table: see text]

Patterns of alcohol consumption in Brazilian adults

In this study, we aimed to describe the patterns of alcohol consumption in Brazilian adults by sociodemographic characteristics and states according to sex. Cross-sectional study including 87,555 adults from the 2019 Brazilian National Health Survey who responded to a questionnaire on alcohol consumption and were classified as non-drinkers (0 g/day), light (1–12.5 g/day), moderate (12.6–49.9 g/day), and heavy drinkers (≥ 50 g/day). Of the Brazilian adults, 73.5% were non-drinkers. Among the drinkers, 14.8% were light drinkers. 82.6% of heavy drinkers were men. White participants drank more than non-white participants, except black women who were 38% more likely to be moderate drinkers than white women (ROR 1.38, 95% CI 1.09 to 1.76). Unmarried were more likely to be drinkers. Women over 55 and men over 65 years old were less likely to be drinkers. Compared to participants with none or incomplete primary education, both men and women with higher educational attainment were more likely to be light and moderate drinkers. The largest consumption of alcohol was found in Sergipe and Mato Grosso for men, and Mato Grosso do Sul and Bahia for women. Our findings may be useful to inform policies for reducing alcohol consumption in Brazil.

Transferrin predicts trimethylamine-N-oxide levels and is a potential biomarker of cardiovascular disease

IntroductionTrimethylamine-N-oxide (TMAO) is a circulating biomarker associated with cardiovascular disease (CVD). Production of TMAO is facilitated by gut microbiota and dependent on micronutrients such as choline, betaine, and L-carnitine, present in foods such as red meat and eggs.HypothesisWe sought to predict serum TMAO quartile levels among healthy individuals at increased risk of CVD using clinical data via an ordinal logistic model.MethodsData from participants (n = 127) enrolled in a longitudinal observational study on CVD were used to build a predictive model for TMAO using ordinal logistic regression with demographic variables and 40 other variables considered related to CVD risk. First, univariate models for each covariate were tested (with serum TMAO quartiles as the dependent variable), and only variables with P < 0.30 were evaluated further. Second, demographic variables (age, gender, white vs. non-white race) were included in a multivariable model with each previously identified independent variable controlling for potential confounding. Last, the final model included fixed demographics and candidates from the confounder-adjusted model with P < 0.10.ResultsEight candidate variables were included in the final model, with only transferrin, high-density lipoprotein cholesterol (HDL-C) and race (white vs. non-white) showing significant associations with TMAO. Participants had 0.16 (Q2), 0.31 (Q3), and 0.20 (Q4) odds of being in a higher TMAO quartile compared with participants in the lowest transferrin quartile. Non-white participants had 2.92 times higher odds of being in the highest TMAO quartile compared to white individuals. Participants in the second quartile of HDL-C had 2.68 times higher odds of being in a higher TMAO quartile compared with participants in the lowest HDL-C quartile.ConclusionsTransferrin demonstrated a significant predictive association with TMAO and may represent a novel potential biomarker of increased CVD risk worthy of further study. These results warrant further examination of iron, metabolism, homeostasis, and gut microbiome to better understand and mitigate known increased CVD risk.

Enrollment of Non-White Participants and Reporting of Race and Ethnicity in Phase III Trials of MS DMTs: A Systematic Review (P4-4.011)

Enrollment of Non-White Participants and Reporting of Race and Ethnicity in Phase III Trials of MS DMTs: A Systematic Review (P4-4.011)

MP31-13 DISPARITIES IN RACE AND ETHNICITY REPORTING IN CONTEMPORARY CLINICAL TRIALS LEADING TO NEW DRUG APPROVALS IN UROLOGY

You have accessJournal of UrologyCME1 May 2022MP31-13 DISPARITIES IN RACE AND ETHNICITY REPORTING IN CONTEMPORARY CLINICAL TRIALS LEADING TO NEW DRUG APPROVALS IN UROLOGY Andres Guillen Lozoya, Vidit Sharma, Bradley Leibovich, Candace Granberg, Patricio Gargollo, and Kevin Koo Andres Guillen LozoyaAndres Guillen Lozoya More articles by this author , Vidit SharmaVidit Sharma More articles by this author , Bradley LeibovichBradley Leibovich More articles by this author , Candace GranbergCandace Granberg More articles by this author , Patricio GargolloPatricio Gargollo More articles by this author , and Kevin KooKevin Koo More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002580.13AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Population-based clinical trials are the foundation of new drug development and approval. However, trial participants frequently do not represent the racial and ethnic composition of the population they are intended to emulate. To assess the impact of recent efforts to improve trial diversity in urology, this study aimed to assess race and ethnicity reporting in clinical trials (CT) leading to recent urological drug approvals. METHODS: We retrospectively reviewed US Food and Drug Administration new drug approvals for urological indications from 2015 through 2021. Published trials that supported these approvals were analyzed to determine reporting of participant race and ethnicity. We calculated proportional race/ethnicity reporting after censoring trials that did not report race/ethnicity in part or overall. The sample was clustered and analyzed by demographic and clinical variables. RESULTS: Of 314 new drug trials, a total of 20 were specific for novel therapies in urology with at least 1 race reported as a baseline characteristic. Of the 18,637 trial participants, 17,629 (95%) included race/ethnicity data (Table 1): 72% White, 15% Asian, 6% Black, 1% Native American, and 6% other unspecified race. Of the total participant sample, only 7,653 (41%) had reported ethnicity; of these, 19% were reported as Hispanic. We found significant differences in reporting rates for participant race and ethnicity rates among trials (p <0.01). The proportional representation of race/ethnicity among trial participants was compared to US population data from the 2020 Census; White participants were significantly overrepresented in drug trials relative to the overall population (72% vs 58%), while Black participants were significantly underrepresented (6% vs 12%; p <0.001). CONCLUSIONS: Despite efforts to improve the racial and ethnic diversity of clinical trial participants, gaps in race/ethnicity reporting and disparities in representation persist in urological drug trials. Non-White trial participants remain underrepresented relative to the US population for drugs targeting cancer and non-cancer conditions. Renewed efforts are urgently needed to ensure inclusive drug trials in urology. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e527 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Andres Guillen Lozoya More articles by this author Vidit Sharma More articles by this author Bradley Leibovich More articles by this author Candace Granberg More articles by this author Patricio Gargollo More articles by this author Kevin Koo More articles by this author Expand All Advertisement PDF DownloadLoading ...

Psychometric Meta-Analysis of the Short Grit Scale Reliability Across Demographic Groups and Academic Settings

The current study is a reliability generalization meta-analysis of the Short Grit Scale (Grit-S). A total of 95,440 participants were found across 66 studies with 117 internal consistency coefficients. We present the average Cronbach coefficient alpha (α) for the total Grit-S and subscales, Consistency of Interest and Perseverance of Effort. The results include total sample percentages for participant characteristics and setting types in which researchers used the Grit-S. The alpha range (α = .68 − .73) indicates the Grit-S and individual subscales are suitable for basic research use but not clinical decision making. Additionally, studies were inconsistent with statistically significant results with participants outside the United States, and reliability coefficients reduced among nonwhite participants. Researchers should further study the reliability of Grit-S among diverse participants.

Examining the role of language competency in genetic testing awareness among adults in the United States.

English language competency, as a component of health literacy, is associated with increased awareness and uptake of health-related genetic testing. The relationship between language competency and genetic testing awareness has not yet been explored in the wider U.S. population yet has significant implications for the practice of genetic counselors and in the promotion of genomic medicine for public health. We analyzed data from the 2017 Health Information National Trends Survey 5 Cycle 1 using weighted logistic regression to model the relationship between self-reported English competency, genetic testing awareness, and race and explore adjusted odds ratios and average marginal effects for levels of English competency. Compared to respondents with high English competency, the probability of genetic testing awareness was 20 percentage points lower for White participants reporting moderate English competency (p=.029) and 37 percentage points lower for non-White participants reporting low English competency (p<.001). Future research is needed to understand the mechanisms through which English competency affects awareness and uptake of genetic testing in the United States and to develop strategies to overcome language barriers for the practice of genetic counselors and the implementation of genetics services.

The quiet purge: a qualitative exploration of sidelining, denigrating and dehumanizing racialized public servants in British Columbia

ABSTRACT This article presents a qualitative exploration of racialized public servants’ lived experiences with workplace racial discrimination in British Columbia, Canada. Specifically, introducing the concept of the quiet purge as the theoretical framework that is used to make sense of data, this study examines experiences of participants with racist pressures at work that had the effect of side-lining and pushing them out to the peripheries of publicly funded workplaces. After detailing a variety of strategies used to recruit 25 non-White participants who worked in the public service and took part in this study, findings would be presented as cultural denigration, accent-mediated dehumanization, emotional fatiguing and precarity-breeding work assignment. In analyzing these findings, this article will conceptualize these racist pressures as the quiet purge, or stratifying mechanisms that were designed to peripheralize and marginalize racialized participants in their respective workplaces. Subsequently, the article will briefly discuss my observations of intersectionality and conclude that, considering the fact that some of the experiences that were recounted by participants describe incidents that were glaringly, unambiguously and blatantly racist – struggles that are often seen as the hallmarks of earlier times – workplace racial discrimination in Canada is alive and requires urgent research and policy attention.

Body size and risk of non-Hodgkin lymphoma by subtype: A pooled analysis from six prospective cohorts in the United States.

In 2022, more than 100 000 non-Hodgkin lymphoma (NHL) diagnoses are expected, yet few risk factors are confirmed. In this study, data from six US-based cohorts (568 717 individuals) were used to examine body size and risk of NHL. Over more than 20years of follow-up, 11 263 NHLs were identified. Hazard ratios (HRs) and 95% confidence intervals (CI) estimated associations with NHLs for adult body mass index (BMI), height, weight change, waist circumference and predicted fat mass. Adult height was broadly associated with NHL, but most strongly with B-cell NHLs among non-White participants (e.g. HRBLACK =2.06, 95% CI: 1.62-2.62). However, the strongest association among the anthropometric traits examined was for young adult BMI and risk of diffuse large B-cell lymphoma (DLBCL), particularly those who maintained a higher BMI into later adulthood. Individuals with BMI over 30kg/m2 throughout adulthood had more than double the DLBCL risk (HR=2.67, 95% CI: 1.71-4.17) compared to BMI 18.5-22.9kg/m2 . Other anthropometric traits were not associated with NHL after controlling for BMI. These results suggest that sustained high BMI is a major driver of DLBCL risk. If confirmed, we estimate that up to 23.5% of all DLBCLs (and 11.1% of all NHLs) may be prevented with avoidance of young adult obesity.

Video education about genetic privacy and patient perspectives about sharing prenatal genetic data: a randomized trial

Laboratories offering cell-free DNA often reserve the right to share prenatal genetic data for research or even commercial purposes, and obtain this permission on the patient consent form. Although it is known that nonpregnant patients are often reluctant to share their genetic data for research, pregnant patients' knowledge of, and opinions about, genetic data privacy are unknown. We investigated whether pregnant patients who had already undergone cell-free DNA screening were aware that genetic data derived from cell-free DNA may be shared for research. Furthermore, we examined whether pregnant patients exposed to video education about the Genetic Information Nondiscrimination Act-a federal law that mandates workplace and health insurance protections against genetic discrimination-were more willing to share cell-free DNA-related genetic data for research than pregnant patients who were unexposed. In this randomized controlled trial (ClinicalTrials.gov Identifier: NCT04420858), English-speaking patients with singleton pregnancies who underwent cell-free DNA and subsequently presented at 17 0/7 to 23 6/7 weeks of gestation for a detailed anatomy scan were randomized 1:1 to a control or intervention group. Both groups viewed an infographic about cell-free DNA. In addition, the intervention group viewed an educational video about the Genetic Information Nondiscrimination Act. The primary outcomes were knowledge about, and willingness to share, prenatal genetic data from cell-free DNA by commercial laboratories for nonclinical purposes, such as research. The secondary outcomes included knowledge about existing genetic privacy laws, knowledge about the potential for reidentification of anonymized genetic data, and acceptability of various use and sharing scenarios for prenatal genetic data. Eighty-one participants per group were required for 80% power to detect an increase in willingness to share data from 60% to 80% (α=0.05). A total of 747 pregnant patients were screened, and 213 patients were deemed eligible and approached for potential study participation. Of these patients, 163 (76.5%) consented and were randomized; one participant discontinued the intervention, and two participants were excluded from analysis after the intervention when it was discovered that they did not fulfill all eligibility criteria. Overall, 160 (75.1%) of those approached were included in the final analysis. Most patients in the control group (72 [90.0%]) and intervention (76 [97.4%]) group were either unsure about or incorrectly thought that cell-free DNA companies could not share prenatal genetic data for research. Participants in the intervention group were more likely to incorrectly believe that their prenatal genetic data would not be shared for nonclinical purposes than participants in the control group (28.8% in the control group vs 46.2% in the intervention; P=.03). However, video education did not increase participant willingness to share genetic data in multiple scenarios. Non-White participants were less willing than White participants to allow sharing of genetic data specifically for academic research (P<.001). Most participants were unaware that their prenatal genetic data may be used for nonclinical purposes. Pregnant patients who were educated about the Genetic Information Nondiscrimination Act were not more willing to share genetic data than those who did not receive this education. Surprisingly, video education about the Genetic Information Nondiscrimination Act led patients to falsely believe that their data would not be shared for research, and participants who identified as racial minorities were less willing to share genetic data. New strategies are needed to improve pregnant patients' understanding of genetic privacy.

Examining the Post-High School Effects of a Primary Prevention Program on Exposure to Bullying and Sexual Violence among Emerging Adults.

Emerging adulthood (EA) is a time of self-exploration as new opportunities for independence and autonomy arise. Yet, for some youth, this may also contribute to instability, uncertainty, and anxiety. Consequently, evidence suggests that rates of exposure to various forms of violence increase in EA. This study examined changes in experiences of bullying and sexual violence (SV) victimization among a sample of post-high school emerging adults who were exposed to a primary prevention program, Sources of Strength (Sources). We also examined whether Sources skills (e.g., healthy coping and help-seeking) buffer against these experiences. Participants were 102 emerging adults (73.5% identifying as female, 36.3% as Latinx, and 22.6% as LGBQ), who completed surveys at three time points: 1month prior to graduation and at 6- and 12-months post-graduation. Results suggest that as youth transition into emerging adulthood, experiences of bullying victimization were relatively low and slightly decreased whereas experiences of SV were also relatively low, but stable over time. Notably, bullying victimization was lower when female-identifying participants, relative to males, had higher levels of healthy coping. In addition, SV victimization for participants identifying as non-white was higher at lower levels of coping than those identifying as white; however, at higher levels of coping, non-white participants reported lower rates of SV victimization, while rates were relatively stable for white participants at high and low levels of coping. These findings provide some support for the Sources program model where engaging in healthy coping may protect young women from bullying exposure and buffer against SV victimization for racial and ethnic minoritized young adults. Implications for violence prevention are discussed.

APOE Effects on Late Life Cognitive Trajectories in Diverse Racial/Ethnic Groups.

This study evaluated: (1) apolipoprotein E (APOE) ϵ4 prevalence among Black, Latino, and White older adults, (2) associations of APOE ϵ4 status with baseline level and change over time of cognitive outcomes across groups, and (3) combined impact of APOE ϵ4 prevalence and magnitude of effect on cognitive decline within each racial/ethnic group. Participants included 297 White, 138 Latino, and 149 Black individuals from the longitudinal UC Davis Diversity Cohort who had APOE genotyping and ≥2 cognitive assessments. Magnitude of associations of ϵ4 with cognitive baseline and change across racial/ethnic groups was tested with multilevel parallel process longitudinal analyses and multiple group models. ϵ4 prevalence in Black (46%) and White participants (46%) was almost double that of Latino participants (24%). ϵ4 was associated with poorer baseline episodic memory only in White participants (p=.001), but had a moderately strong association with episodic memory change across all racial/ethnic groups (Blacks=-.061 SD/year, Latinos =-.055,Whites=-.055). ϵ4 association with semantic memory change was strongest in White participants (-.071), intermediate in Latino participants (-.041), and weakest in Black participants (-.022). Calculated cognitive trajectories across racial/ethnic groups were influenced in an additive manner by ϵ4 prevalence and strength of association with cognitive decline within the group. Group differences in ϵ4 prevalences and associations of ϵ4 with cognition may suggest different pathways from APOE to cognitive decline, and, AD possibly having less salient impact on cognitive decline in non-White participants. Differential effects of APOE on episodic memory and non-memory cognition have important implications for understanding how APOE influences late life cognitive decline.

MS Trials Continue to Under-Report, Under-Represent Non-White Participants

MS Trials Continue to Under-Report, Under-Represent Non-White Participants

Racial, Ethnic, and Nativity Disparities in Physical Activity and Sedentary Time among Cancer Prevention Study-3 Participants.

Understanding racial/ethnic and nativity disparities in physical activity (PA) is important, as certain subgroups bear a disproportionate burden of physical inactivity-related diseases. This descriptive study compared mean leisure-time moderate-to-vigorous intensity physical activity (LTMVPA) by race/ethnicity and nativity. The Cancer Prevention Study-3 (78.1% women; age, 47.9 ± 9.7 yr) includes 4722 (1.9%) Asian/Pacific Islander; 1232 (0.5%) Black/Indigenous (non-White) Latino; 16,041 (6.5%) White Latino; 9295 (3.8%) non-Latino Black; 2623 (1.1%) Indigenous American; and 210,504 (85.7%) non-Latino White participants across the United States and Puerto Rico. Participants completed validated LTMVPA and 24-h time use surveys at enrollment (2006-2013). Differences in LTMVPA across race/ethnicity and nativity were examined by ANCOVA with paired Tukey tests adjusting for age and sex. The proportion of time spent sitting, sleeping, and on PA by race/ethnicity was also compared. There were significant differences in LTMVPA by race/ethnicity (race main effect, P < 0.001; nativity, P = 0.072; interaction, P < 0.001). Pairwise comparisons showed that White participants born abroad were the most active (23.8 MET-h·wk-1) and non-White Latino participants born abroad were the least active (17.9 MET-h·wk-1). Among Latinos, participants born in Puerto Rico were 6.6-7.3 MET-h·wk-1 less active than participants born in Mexico, the United States/Canada, or other countries. There were variations in time use by race/ethnicity, with the largest difference in time spent sitting while watching TV. Black participants spent 14.8% of the day (~3.5 h) sitting watching TV, which was 78 min longer than Asian/Pacific Islander participants. This study suggests that there are differences in LTMVPA accumulation by race, ethnicity, and nativity. Results can be used to identify demographic groups that may benefit from culturally tailored PA interventions.

P404 Underrepresentation of minorities and lack of race reporting in ulcerative colitis drug development clinical trials

Abstract Background Historically, inflammatory bowel disease (IBD) trials report high enrollment rates for white-caucasian patients. To promote initiatives towards diversifying patients enrolled in clinical trials, we assessed the reporting of race/ethnicity of patients enrolled in pharmaceutical clinical trials for ulcerative colitis (UC). Methods A previous systematic review of all placebo-controlled trials in adult patients with UC examining different therapeutic drug classes was performed from inception to December 2020. Trial and patient characteristics were summarized according to the type of variable. Categorical variables were summarized by displaying the number and percentage of trials or participants for each category. Continuous variables were summarized by displaying the weighted mean, weighted standard deviation, and range. Means and standard deviations (SD) were weighted by the number of participants in each trial. Results Descriptive statistics of trial and patient characteristics for, 95 induction trials and, 29 maintenance trials are summarized in Table, 1. Race was reported in, 37.9% (36/95) of induction studies, with most participants being White (86.3%;, 8610/9976). Furthermore, 21/36 (58.3%) studies reported race as White vs. non-White participants; and, 15/36 (41.7%) studies provided further breakdown, including Black (115/3414 patients [3.4%]), Asian (448/4136 patients [10.8%]), and “Other” (127/4136 patients [3.1%]). Moreover, 3/36 studies misreported race as ethnicity and, only, 3/36 studies reported ethnicities correctly, classifying patients as Hispanic/Latinx vs. Non-Hispanic/Latinx. For maintenance trials, 34.5% (10/29) studies reported race, with majority of participants being White (85.6%;, 2778/3246). Additionally, 6/10 studies reported only a White vs. non-White participants comparison, while, 4/10 reported other races, including Black (45/1145 patients [3.9%]), Asian (40/888 patients [4.5%]), and “Other” (26/1145 patients [2.3%]). No studies reported ethnicity. Conclusion Given the increasing burden of IBD in developing countries, differences amongst racial and ethnic groups are important to understand since they can influence disease phenotype, response to therapy, and safety outcomes.1 We found poor race reporting in UC clinical trials and observed that the vast majority of participants enrolled were White. These findings suggest that the population prevalence of UC amongst different racial groups is not reflected in clinical trial populations, being important to raise awareness of the existing barriers that prevent patients from accessing clinical trials. Reporting of race and ethnicity in UC clinical trials should be mandatory, and a requirement to enroll a certain percentage of non-White patients should be considered.2

Increasing Ancestral Diversity in Systemic Lupus Erythematosus Clinical Studies.

Non-White people are more likely to develop systemic lupus erythematosus (SLE) yet are underrepresented in SLE clinical trials. The efficacy and safety of drugs may be influenced by ancestry, and ancestrally diverse study populations are necessary to optimize treatments across the full spectrum of patients. However, barriers to entry into clinical trials are amplified in non-White populations. To address these issues, a conference was held in Bethesda, Maryland, from October 15-16, 2019, entitled "Increasing Ancestral Diversity in Systemic Lupus Erythematosus Clinical Studies: Overcoming the Barriers." Conference participants included people with lupus, lupus physicians, lupus clinical trialists, treatment developers from biotechnology, social scientists, patient advocacy groups, and US government representatives (The Office of Minority Health, Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Administration). For all these groups, the organizers of the conference purposefully included people of non-White ancestry. Decreased participation of non-White SLE patients in clinical research was evaluated through historical, societal, experiential, and pragmatic perspectives, and several interventional programs to increase non-White patient participation in SLE and non-SLE research were described and discussed. The presentations and discussions highlighted the need for changes at the societal, institutional, research team, referring physician, and patient education levels to achieve equitable ancestral representation in SLE clinical studies.

Enrollment of Non-White Participants and Reporting of Race and Ethnicity in Phase III Trials of Multiple Sclerosis DMTs: A Systematic Review.

Black and Hispanic people with multiple sclerosis (MS) (pMS) have been found to have different disease courses or worse outcomes associated with MS compared to White pMS. They are also more likely to be negatively affected by social determinants of health, further worsening disparities in outcomes. As these disparities may affect treatment response, non-White pMS must be included in trials for greater generalizability of research and therefore more inclusive treatment plans. In this study, we aimed to evaluate how representation of non-White groups in phase III trials of approved disease-modifying therapies (DMTs) has evolved over time and how race and ethnicity are reported in medical journals and on manufacturer websites. We conducted a systematic review of the PubMed database from 1995 to June 2020 to identify manufacturer-sponsored phase III trials for Food and Drug Administration-approved MS DMTs. We explored how race and ethnicity were reported in trial publications. Using studies where information was available, we analyzed the representation of non-White pMS over time and compared to multinational census data. We reviewed patient- and health care provider (HCP)-facing websites of available DMTs to assess the dissemination of information on racial and ethnic representation in trials. A total of 44 phase III trial publications were reviewed, representing 45 trials, among which 17 (37.8%) did not report race or ethnicity, 14 (31.1%) reported race and ethnicity as proportion of White participants only, and 14 (31.1%) reported 2 or more races/ethnicities. When compared to multinational census data, non-White pMS were significantly underrepresented in MS trials. Due to lack of data, trends in representation of other races and ethnicities could not be assessed. No patient- or HCP-facing DMT websites reported data on race and ethnicity in pivotal trials. Study results are available on our study dashboard. Race and ethnicity are underreported in MS DMT trial publications and race and ethnic representation are omitted from manufacturer websites. When available, data show that non-White pMS are significantly underrepresented in MS trials. The availability of this information is crucial for patients, together with their HCPs, to make informed decisions about their care.

A review of the inclusion of ethnoracial groups in empirically supported posttraumatic stress disorder treatment research.

Empirically supported treatments (ESTs) have been criticized for lack of ethnoracial representation, which may limit the generalizability of findings for non-White patients. This study assessed ethnoracial representation in United States-based randomized controlled trials (RCTs) for three evidence-based treatments for posttraumatic stress disorder (PTSD)-Prolonged Exposure (PE), Cognitive Processing Therapy (CPT), and Eye-Movement Desensitization and Reprocessing (EMDR). Representation was measured by explicit inclusion of people of color in published PTSD RCTs. Follow-up emails were sent to corresponding authors if full demographic information was not included in the reviewed manuscripts. Information concerning participant remuneration was collected for descriptive purposes. All three treatment modalities reported White participants as the majority in their sample. PE and CPT trials reported similar levels of ethnoracial diversity, while EMDR efficacy studies reported the least ethnoracial diversity. Across the reviewed studies, with few exceptions, we found low numbers of non-White participants in the majority of reviewed studies, which was compounded by poor or unclear methods of reporting ethnoracial information. This study demonstrates that the ESTs for PTSD are not adequately representative of the majority of non-White participants. Future RCTs should place a stronger emphasis on broad ethnoracial diversity in study participants to improve generalizability of findings. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Secular and Regional Trends among Pulmonary Arterial Hypertension Clinical Trial Participants.

Rationale: The population of patients with pulmonary arterial hypertension (PAH) has evolved over time from predominantly young White women to an older, more racially diverse and obese population. Whether these changes are reflected in clinical trials is not known. Objectives: To determine secular and regional trends among PAH trial participants. Methods: We performed a pooled cohort analysis using harmonized data from phase III clinical trials of PAH therapies submitted to the U.S. Food and Drug Administration. We used mixed-effects linear and logistic regression to assess regional differences in participant age, sex, body habitus, and hemodynamics over time. Results: A total of 6,599 participants were enrolled in 18 trials between 1998 and 2013; 78% were female. The mean age of participants in North America, Europe, and Latin America at the time of study start increased by 2.09 (95% confidence interval [CI], 0.67-3.51), 1.62 (95% CI, 0.24-3.00), and 4.75 (95% CI, 2.29-7.21) years per 5 years, respectively (P = 0.01). Body mass index at the time of study start increased by 0.72 kg/m2 per 5 years (95% CI, 0.44-0.99; P < 0.001) across all regions. Eighty-five percent of participants in early studies were non-Hispanic White, but this decreased over time to 70%. Ninety-seven percent of Asians and 74% of Hispanics in the sample were recruited from Asia and Latin America. Conclusions: Patients enrolled in more recent PAH therapy trials are older and more obese, mirroring the changing epidemiology of observational cohorts. However, these trends varied by geographic region. PAH cohorts remain predominantly female, presenting challenges for generalizability to male patients. Although the proportion of non-White participants increased over time, this was primarily through recruitment in Asia and Latin America.