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- New
- Research Article
- 10.1161/jaha.125.041674
- Jan 6, 2026
- Journal of the American Heart Association
- Shumei Man + 10 more
Delayed hospital arrival after 4.5 hours of stroke onset excludes patients from intravenous thrombolytic therapy. In the United States, prehospital triage is regulated by each state. Understanding race- and ethnicity-specific prehospital delays in each state could guide targeted interventions. This cross-sectional study examined adult patients treated at the GWTG (Get With The Guidelines)-Stroke participating hospitals from January 2021 to August 2023 for acute ischemic stroke. The outcomes, including onset-to-arrival >4.5 hours, onset-to-911 call >2.5 hours, and 911 call-to-arrival >1 hour by race and ethnicity and state, were examined using multivariable logistic regression analysis adjusting for patient and hospital-level characteristics. The study included 691 689 patients with a median age of 71 years and 48.6% women. Compared with White patients, risk-adjusted odds of onset-to-arrival >4.5 hours were higher in Asian patients (1.24 [95% CI, 1.20-1.28]), Black patients (1.18 [95% CI, 1.16-1.19]), and Hispanic patients (1.10 [95% CI, 1.07-1.12]); onset-to-911 call >2.5 hours was higher among Black patients (1.21 [95% CI, 1.16-1.26]); and 911 call-to-arrival >1 hour was lower among Asian (0.55 [95% CI, 0.49-0.63]), Black patients (0.67 [95% CI, 0.62-0.72]), and Hispanic patients (0.69 [95% CI, 0.63-0.75]). Relative to Texas, which has the highest racial and ethnic diversity index, the odds of onset-to-arrival >4.5 hours were higher in 20 states for non-White patients and 9 states for White patients. Delayed hospital arrivals are more prevalent among Asian, Black, and Hispanic patients, but emergency medicine service transportation times are shorter, suggesting the need for culturally tailored community stroke education. A few states have exceedingly high delayed arrival, highlighting an opportunity to improve state-wide stroke readiness and emergency medicine service triage.
- New
- Research Article
- 10.1016/j.cct.2025.108141
- Jan 1, 2026
- Contemporary clinical trials
- Tenzin Yeshi Wangdak Yuthok + 12 more
Trial of SiTes to IncreAse diversity in clinical TriaLs (TOTAL): A study protocol paper.
- New
- Research Article
- 10.1007/s12055-025-02025-3
- Jan 1, 2026
- Indian journal of thoracic and cardiovascular surgery
- Marc R Moon
Diversity in cardiothoracic surgery will not occur passively. It requires a concerted effort. Historically, cardiothoracic surgery has been one of the least diverse specialties in medicine. The first woman was certified by the American Board of Thoracic Surgery in the early 1960s, nearly one-half century after the specialty was established, but progress from there continued slow. It took another 20years before the number of women cardiothoracic surgeons exceeded one dozen. More recent efforts by leaders in the specialty have focused on making the specialty more attractive to women with a view towards making cardiothoracic training seem normal, regardless of the trainee's gender. Diversifying any specialty begins with recruitment, mentorship, support, and finally sponsorship to cultivate future leaders with merit-based promotion. These principles are not only applicable for gender diversity but also for racial and ethnic diversity. The American Association for Thoracic Surgery Medical Student Diversity Scholarship exemplifies a concerted effort to encourage diversity in cardiothoracic surgery. Early reports from this program are encouraging and demonstrate the potential outcome of a group committed to taking action and making a long-term positive change.
- New
- Research Article
- 10.5423/rpd.2025.31.4.421
- Dec 31, 2025
- Research in Plant Disease
- Dan-Dan Zhao + 9 more
Since the nationwide outbreak of rice blast disease caused by Magnaporthe oryzae in Korea in the late 1970s, the Korean unique race differential system was developed, and numerous studies on rice blast disease and rice blast resistance have been conducted to prevent the breakdown of blast resistance in rice varieties in the field. Race distribution and diversity of rice blast isolates have been identified over the past four decades through the Korean unique race differential system. The Korean unique race differential system, composed of eight different rice cultivars, can distinguish rice blast isolates into 15 KJ-races infecting Japonica-type varieties and 240 KI-races infecting Indica-, Indica/Japonica hybrid-, and Japonica-type varieties. This study revealed annual distribution and dynamics of the race structures of rice blast fungus in Korea from 1995 to 2020. A total of 128 races, comprising 15 KJ-races and 113 KI-races were shown, and the ratio of KJ isolates to KI isolates changed in cycles of 3-5 years over the past 26 years. This study also examined the transition of race diversity and the emergence of new races from 1995 to 2020, as well as the limits of the race differential system.
- New
- Research Article
- 10.1002/mdc3.70482
- Dec 30, 2025
- Movement disorders clinical practice
- Farley Reis Rodrigues + 10 more
There is a historic underrepresentation of non-White participants in Parkinson's Disease (PD) research, although this has not been explored in trials for potential disease-modifying therapies. To evaluate the representation of racial/ethnic minority patients enrolled in double-blind, randomized, placebo-controlled clinical trials (DBRCTs) for PD. A systematic search of four electronic databases was performed. DBRCTs evaluating pharmacological therapies for disease modification in PD were included. Data extraction followed PRISMA guidelines. We computed demographic data with pooled prevalence and 95% confidence intervals (CIs). Among 37 DBRCTs and 11,022 patients, 19 studies (51.4%) reported race/ethnicity, being 1.4% Asian, 0.19% Black, and 0.17% Hispanic. Pooled prevalence of participants identified as White in clinical trials was 98% (CI 0.97-0.99, P < 0.001). Racial and ethnic minorities were disproportionately underrepresented in DBRCTs for potential disease-modifying therapies for PD. Additional efforts are required to increase the racial and ethnic representation in such studies.
- New
- Abstract
- 10.1002/alz70858_103347
- Dec 26, 2025
- Alzheimer's & Dementia
- Shardae Showell + 2 more
BackgroundAfter decades of waiting, two amyloid directed immunotherapies for AD provide hope for patients. However, social vulnerability and a lack of easily accessible infusion centers may unduly limit those living with AD from receiving treatment. Despite the abundance of healthcare services in U.S. metropolitan areas, systemic, economic, and social challenges leave many marginalized communities underserved. Here we explored how social factors relate to access to infusion centers in metropolitan areas.MethodMetropolitan areas with racial (>45% non‐white) and/or ethnic (>20% Hispanic/Latino) diversity across the US were selected (Atlanta, GA; Chicago, IL; and Houston, TX) for examination of infusion deserts (IDs) using National Infusion Center Association Locator Data to identify areas with >5 miles radius to the nearest infusion center. Social, economic, and environmental characteristics between IDs and non‐IDs were compared using CDC PLACES data and the Agency for Healthcare Research and Quality Social Determinants of Health Database.ResultIDs showed greater social, economic, and environmental vulnerability compared to non‐IDs. Median household income ranged from 24%‐42% lower in IDs with a higher proportion of households living below the 150% Federal Poverty Level than in non‐IDs. In Atlanta and Chicago, IDs had a 3‐4% higher proportion of vacant housing than non‐IDs, but in Houston proportions were similar between IDs and non‐IDs. Older adults in IDs were more likely to live alone than older adults in non‐IDs (Table 1).IDs had a higher proportion of those who were unemployed, food stamp/SNAP recipients, and lacked a high school diploma; and were less likely to have broadband access compared to non‐IDs. Insurance coverage differed, with non‐IDs having a larger proportion of residents on commercial insurance compared to IDs; IDs showed larger proportions of residents uninsured or on Medicaid compared to non‐IDs.ConclusionIDs showed greater economic and social vulnerability among residents compared to non‐IDs. Older adults were more likely to live alone in IDs, potentially compounding difficulty in accessing disease modifying therapies for early AD. These challenges prevent many individuals from accessing breakthrough AD therapies, which are crucial for improving health outcomes in disproportionately affected communities.
- New
- Research Article
- 10.1080/03906701.2025.2607117
- Dec 24, 2025
- International Review of Sociology
- Cubeddu Francesca
ABSTRACT For immigrants, the Mediterranean Sea is both a meeting place where they can find salvation as well as an immense obstacle that very often leads to their death. Immigration and its effects are currently a hot topic of public and media debate throughout the Mediterranean area. In 2023, there was an increase in migration flows, making it once again a central topic in public debate, accompanied by both criticism and expressions of hatred. These expressions are often the cause of political conditioning that influences the media. Hate speech is the expression of a process determined by social construction with respect to the false myth attributed to immigrants, creating fake news, along with a distorted perception of immigrants. The aim of this article is to analyse these dynamics within the Italian communication context, observing how immigrants are perceived, starting from the false myths that are both spread in and by social media as well as accepted as real by public opinion. It will highlight the measures to combat hate speech promoted by associations, which allow social hatred online to be regulated through various strategies, including the promotion of kindness and good speech, using terms that tend to unite rather than divide.
- New
- Research Article
- 10.3390/agronomy16010041
- Dec 23, 2025
- Agronomy
- Shengjie Zhang + 6 more
Rice blast, caused by Magnaporthe oryzae, is a devastating global disease. Its control through the deployment of host resistance genes relies on a detailed knowledge of the pathogen’s race structure and the corresponding avirulence (Avr) genes. To guide effective rice breeding for blast resistance, this study investigated the population dynamics of M. oryzae in Jilin Province from 2022 to 2024. The distribution frequencies of seven Avr genes were detected using PCR and avirulence gene-specific primers, and the physiological race structure of 193 isolates was characterized using a set of Chinese differential cultivars, which contains seven cultivars. The results revealed a high prevalence and stability of specific Avr genes, with Avr-Pi9, Avr-Pias, Avr-Piz-t, and Avr-Pib all exhibiting detection frequencies exceeding 80%. In particular, Avr-Pib showed a high frequency (80.83%) and a very low disease incidence (0.64%) on the differential variety Sifeng 43 (which carries Pib), confirming its low mutation rate and the ongoing effectiveness of the corresponding resistance gene. Conversely, the significant decline in Avr-co39 suggests that its corresponding resistance gene should be avoided. Race diversity increased over the three-year period, characterized by a shift toward a more complex structure dominated by ZG1, ZA17, ZA43, and ZB31. Based on the gene-for-gene interactions and pathogen population structure, we recommend a breeding strategy that prioritizes the incorporation of the highly effective Pib, Pi54, and Pik genes, utilizing resistant donors like Sifeng 43. These results can help inform the design of sustainable management strategies adapted to the changing pathogen population.
- New
- Research Article
- 10.3389/fpubh.2025.1658436
- Dec 19, 2025
- Frontiers in Public Health
- Devon C Payne-Sturges
BackgroundThe global reckoning on race and racism in 2020 ushered in new or enhancement of existing governmental anti-discrimination and anti-racism initiatives at EU and German Federal levels. However, the role of racism, particularly structural racism, in health appears to be missing from community health and medical training and research, and from larger policy debates on environmental justice and health equity in Germany.Design/MethodsParticipants were purposively recruited across 10 German cities selected to represent regional variability in racial diversity and engaged in semi-structured in-depth interviews that were audio-recorded and transcribed verbatim. Using thematic analysis, these qualitative interviews with 14 anti-racism researchers, community-based advocates and educators knowledgeable about environmental justice, racism, public health who identified as Black or Afro-German and/or work on behalf of racialized communities in Germany were analyzed to explore the challenges faced by minoritized communities in Germany in relation to environmental justice and health inequities, as well as strategies for addressing these issues.ResultsParticipants enumerated a number environmental conditions likely disproportionately impacting racialized minority groups in Germany. The extent of these issues is not known due to lack of data and empirical studies. Participants pointed to the myriad ways racism is structured in Germany, tracing how racialized and racially hierarchical values and beliefs become actualized through racially discriminatory policies and practices embedded in social institutions such as the government, the economy, the education system and the healthcare system which lead to racialized outcomes in health and environmental conditions.ConclusionsInterview participants identified pathways toward more effective research and policy initiatives on racism, environmental justice, community health and environmental heath equity in Germany including: collecting better data that is informed by structural theories of race/racialization and power; addressing history and national narratives; supporting more community-based participatory action research; engaging with existing civil society and non-governmental organizations that serve and advocate on behalf of minoritized communities; and building upon past and present progressive social movements.
- New
- Research Article
- 10.3390/youth6010001
- Dec 19, 2025
- Youth
- Elaine Les + 5 more
Peer role models are an important factor in supporting academic achievement, social development, and mental health, particularly in out-of-school-time (OST) programs that emphasize character and leadership. This mixed-methods study explored whether Scouts’ racial/ethnic identity was associated with identifying a peer role model and examined the character assets youth valued in those role models. We purposively sampled 104 Scouts (aged 11–18), 89% male and 70% White, with additional racial diversity across all U.S. regions. Interviews were analyzed using both quantitative and qualitative approaches. Most Scouts identified a peer role model, and there were no significant differences in identification or valued characteristics across racial/ethnic groups. Scouts most frequently valued character assets related to caring, contribution, and connection. These findings point to the value of structured, youth-led, multi-age OST environments, indicating that program policies which embed opportunities for peer role modeling may help promote character development across diverse backgrounds.
- Research Article
- 10.1017/s0080440125100510
- Dec 16, 2025
- Transactions of the Royal Historical Society
- Eleanor Newbigin + 1 more
Abstract The Royal Historical Society’s June 2024 Update to the ‘Race Ethnicity & Equality in UK History: A Report and Resource for Change’ notes some important progress in terms of increased ethnic and racial diversity amongst history students and staff but acknowledges that more work is needed to both sustain and further advance these changes. In this Comment we argue that colleagues and the RHS should prioritise the development of critical pedagogies in history university education and evidence their impact on student outcomes. We share reflections on and data from our collaborative work between September 2021 and August 2024 developing an innovative module with the highly diverse history student cohort at SOAS, University of London, to help colleagues consider how they might undertake related projects in their own institutions.
- Research Article
- 10.1080/15435075.2025.2598538
- Dec 14, 2025
- International Journal of Green Energy
- Ted Peterson
ABSTRACT This quantitative study investigates generational differences in environmental attitudes and energy preferences by surveying 1209 Utah utility customers in 2022. The primary objective is to determine whether Baby Boomers, Generation X, Millennials, and Generation Z differ in (1) the perceived importance of reducing energy use, (2) household efficiency practices, (3) recent conservation actions, (4) year-over-year utility consumption changes, and (5) interest in voluntary renewable energy programs. Generational cohorts were operationalized by self-reported age, and analyses employed t-tests, chi-square tests, Kruskal-Wallis, and Dunn’s post hoc comparisons to assess differences across groups. Results reveal no significant variance across generations in energy reduction importance, efficiency comparisons, or consumption trends; however, Millennials and Generation Z show significantly greater interest (p < .05) in enrolling in renewable energy programs. Demographically, older cohorts report higher household incomes, while Generation Z exhibits lower marriage rates and greater racial diversity. Political satisfaction also varies, with Boomers reporting higher satisfaction levels with their electric and natural gas utilities, contrasted by younger cohorts’ preference for electric water and space heating systems over natural gas. This study is novel in applying a comprehensive suite of statistical techniques to a large, utility-based survey. By focusing on nuanced self-reported behaviors across four distinct age cohorts, it advances academic understanding of how generational profiles may shape sustainable energy adoption and provides actionable insights for policymakers seeking to tailor renewable program offerings and engagement strategies. Future research should extend these insights across diverse geographical contexts and incorporate consumption data.
- Research Article
- 10.1111/jmwh.70068
- Dec 13, 2025
- Journal of midwifery & women's health
- Kimberly Navarro
Black Women's Perceptions of Race-Concordant Midwifery Care and Home Birth: Liberation in Labor.
- Research Article
- 10.1093/jsxmed/qdaf320.285
- Dec 9, 2025
- The Journal of Sexual Medicine
- N Corsi + 5 more
Abstract Introduction Peyronie’s Disease (PD) is a stigmatized topic. Many men way turn to the internet for information given its accessibility and privacy. YouTube and TikTok are both popular internet video platforms for information gathering. As there is an increasing role of online content influencing health care decisions made by patients, physicians should be aware of the quality of content the patients are exposed to prior to their first consultation with a urologist. Objective We sought to identify the top YouTube and TikTok videos focused on PD and assess the quality of consumer health information. Methods Using the key word “Peyronie’s disease,” the first 100 videos based on relevance and user engagement were identified. The top 50 videos on each platform were then reviewed. Three videos were excluded on TikTok and 4 were excluded on YouTube as they did not meet criteria. Video information was coded and analyzed. The quality of consumer health information was rated using the DISCERN instrument. DISCERN instrument consists of 15 questions plus an overall content quality rating, each scored on a 5-point scale, that in turn discriminates between high- and low-quality information. Shapiro-Wilk tests assessed normality and Mann-Whitney U test was conducted. Results On YouTube, most speakers were urologists (86%), followed by business professionals (10%), news channels reporters (2%), and finally non-urologist physicians (2%). TikTok showed a similar distribution: urologists (85.7%), content creators (12.2%), and finally non-urologist physicians (2%). Across both platforms, 84% of speakers were male. Racial distribution showed 79.6% of TikTok speakers were Caucasian, compared to 70% on YouTube. View count was not significantly different for both platforms with median TikTok views of 12391.6 (IQR 5052-39713) and median YouTube views of 13757 (IQR 2401-69116), p=0.74. YouTube videos had a significantly higher median DISCERN score (62, IQR: 50.5-73) than TikTok videos (46, IQR: 35–55; p &lt; .00001). This remained true when comparing urologist content creation on YouTube (61.5, IQR 51.75-73.0) versus TikTok (51, IQR 45.25-59.0, p=0.0035). Urologists had higher median DISCERN scores (51.0, IQR 45.25-59.0) when compared to all other creators (40.5, IQR 26.0-50.5, p=0.025). YouTube had insufficient power for non-urologists and creators to compare groups. Conclusions While both YouTube and TikTok serve as platforms for disseminating health information, YouTube content- particularly urologist created- demonstrated higher quality information based on DISCERN scores. This underscores the importance of expert-led content creation. However, despite the strong presence of urologists, the landscape remains homogenous with most speakers being male and Caucasian. This lack of gender and racial diversity highlights an important need to create a more inclusive and culturally responsive urologic health communication. Disclosure No
- Research Article
- 10.1111/tct.70293
- Dec 8, 2025
- The clinical teacher
- Samuel Cooper + 2 more
The underrepresentation of skin of colour in medical educational textbooks has been demonstrated in a variety of specialties. The representation of skin colour in UK ophthalmology textbooks remains unquantified. Without adequate racially diverse educational resources for medical trainees, there is a risk to patient outcomes and diagnostic delays. In this paper, we aim to analyse the representation of skin colour to inform the development of future textbooks on the importance of racial inclusivity and diversity. Four bestselling UK ophthalmology textbooks were reviewed using the Fitzpatrick's skin phototype scale to categorise images into Caucasian (Fitz I-III), medium (Fitz IV) and richly pigmented (Fitz V and VI). To assess reliability, a second observer reclassified a 10% sample. Images where skin colour was not representable were excluded. A total of 1644 images were reviewed, of which 460 were included for analysis. Across the 460 images, 86.5% demonstrated Fitz I-III skin, and only 7.60% and 5.87% demonstrated Fitz IV and Fitz V and VI skin, respectively. The proportion of richly pigmented images was statistically significantly lower than the national demographic data suggesting an inadequacy in the representation of those from non-Caucasian backgrounds. Addressing this gap is essential to ensure equitable care for patients of all backgrounds.
- Research Article
- 10.51743/cpe.479
- Dec 5, 2025
- Cuadernos de Pensamiento
- William Tullius
Edith Stein published An Investigation Concerning the State in 1925, the same in in which Hitler’s Mein Kampf first appeared. Stein’s analysis of political theory there demonstrates her awareness of what she would later describe to Pope Pius XI as a growing ‘idolization of race’ that was beginning to infect German culture. Her analysis of ethnic community in that work very obviously represents an effort to combat the intellectual bases for any form of racism in political and cultural life in her contemporary Germany. Over time, Stein’s demonstrated commitment to ethnic and racial diversity in society develops into a general theological and metaphysical vision of diversity as being integral for human development, i.e., for the unfolding ofuniversal humanity across time. In tandem with this further development, Stein’s approach to undermining the spiritual bases for racism in society shifts from discussion in light of politics to discussion in light of pedagogy, indicating the important role that education is to play in fulfilling the goal of human development. This paper seeks to bring Stein’s philosophy of race and her philosophy of education into focus in order to understand how each works together with the other in Stein’s response to racial prejudice.
- Research Article
- 10.3390/su172310873
- Dec 4, 2025
- Sustainability
- Maged Zagow + 2 more
Over recent decades, planners in the U.S. have increasingly adopted mixed-use projects to reduce automobile dependency and strengthen local community identity, although results remain inconsistent across cities. Urban health and fitness outcomes are shaped by complex interactions between the built environment, socioeconomic factors, and demographic characteristics. This study introduces a Health and Fitness Index (HFI) for 28,758 U.S. ZIP codes, derived from normalized measures of walkability, healthcare facility density, and carbon emissions, to assess spatial disparities in health-supportive environments. Using four modeling approaches—lasso regression, multiple linear regression, decision trees, and k-nearest neighbor classifiers—we evaluated the predictive importance of 15 urban and socioeconomic variables. Multiple linear regression produced the strongest generalization performance (R2 = 0.60, RMSE = 0.04). Key positive predictors included occupied housing units, business density, land-use mix, household income, and racial diversity, while income inequality and population density were negatively associated with health outcomes. This study evaluates five statistical formulations (Metropolis Hybrid Models) that incorporate different combinations of walkability, land-use mix, environmental variables, and socioeconomic indicators to test whether relationships between urban form and socioeconomic conditions remain consistent under different variable combinations. In cross-sectional multivariate regression, although mixed-use development in high-density areas is strongly associated with healthcare facilities, these areas tend to serve younger and more racially diverse populations. Decision tree feature importance rankings and clustering profiles highlight structural inequalities across regions, suggesting that enhancing business diversity, land-use integration, and income equity could significantly improve health-supportive urban design. This research provides a data-driven framework for urban planners to identify underserved neighborhoods and develop targeted interventions that promote walkability, accessibility to health infrastructure, and sustainability. It contributes to the growing literature on urban health analytics, integrating machine learning, spatial clustering, and multidimensional urban indicators to advance equitable and resilient city planning.
- Abstract
- 10.1002/alz70858_101136
- Dec 1, 2025
- Alzheimer's & Dementia
- Shardae Showell + 2 more
BackgroundRecent advances in Alzheimer's disease (AD) treatment include approval of two amyloid directed immunotherapies administered via intravenous infusion. These therapies require access to infusion centers, making availability of such facilities critical for effective treatment delivery. We examined accessibility of infusion centers across three cities in the United States. Our analyses aimed to identify patients with limited access to treatment and assess whether these gaps align with known disparities in Alzheimer's disease.MethodThree large metropolitan areas (Atlanta, GA; Chicago, IL; Houston, TX) with ethnic (>20% Hispanic/Latino) and/or racial diversity (>45% non‐white) were selected to examine characteristics of residents living in infusion deserts (IDs). The National Infusion Center Association Locator Data was used to examine gaps in availability at the neighborhood/census tract level with an ID defined as an area where the closest infusion center >5 miles radius. Demographic characteristics were compared between IDs and non‐IDs using CDC PLACES data.To estimate the number of 65+ years amyloid‐positive (Aβ+) MCI due to AD and mild AD individuals in an infusion desert, we applied estimates of MCI/AD prevalence, AD severity, and amyloid abnormality to the estimates of those 65+ living in an ID.ResultAcross three US metropolitan areas, approximately 12% of the population live in an ID. Among people 65+ years, approximately 18k living with Aβ+ MCI due to AD and 8k living with Aβ+ mild AD resides in an ID in one of these three cities (Table 1).IDs showed a higher proportion of Hispanic/Latino residents compared to non‐IDs, ranging from 1% higher in Atlanta to 12% higher in Houston. A higher proportion of Black/African American individuals and a lower proportion of White and Asian individuals reside in an ID compared to non‐ID areas. Differences in the proportion of Black/African American race between ID and non‐IDs ranged from 7.7% higher in ID for Houston to 42.8% higher in Atlanta (Table 2).ConclusionApproximately 26k individuals 65+ years with Aβ+ early AD are living in an ID across Atlanta, Chicago, and Houston. Locations of IDs are disproportionately Black/African American and Hispanic/Latino compared to non‐IDs, suggesting potential inequalities in access to new treatments for AD.
- Abstract
- 10.1002/alz70858_098408
- Dec 1, 2025
- Alzheimer's & Dementia
- Sarah Horn + 8 more
BackgroundBoth quetiapine and pimavanserin are commonly used in clinical practice for psychosis (hallucinations and/or delusions) in Parkinson's disease (PD) and dementia with Lewy bodies (DLB) ‐ collectively referred to as Lewy body disease (LBD). Clinical trials to establish efficacy have been small, with mixed results, indicating the classic clinical trial model may be ill‐equipped to capture the real‐world benefits seen in routine clinical practice. Historically, the rigorous nature of traditional, randomized, double‐blind, placebo‐controlled clinical trials evaluating treatments for dementia and neuropsychiatric symptoms of PD has been fraught with recruitment and retention issues. Furthermore, there has been a lack of racial and ethnic diversity among participants in published clinical trials in these populations, thereby limiting their power and generalizability to the general population. Notably, less than 1% of participants in published trials pertaining to neuropsychiatric symptoms in PD are Hispanic.MethodAn investigator‐initiated, local, pragmatic, randomized, unblinded clinical trial comparing quetiapine and pimavanserin for the treatment of LBD psychosis is ongoing in San Antonio, Texas, which is a majority‐Hispanic city. The medication chosen via randomization is prescribed and managed per routine care. Baseline and follow‐up trial visits are performed during routine appointments, intertwined with clinical care. The primary outcome measure of the trial is change in the sum of the Neuropsychiatric Inventory Questionnaire (NPI‐Q) hallucination and delusion items, from baseline to 6 months. Secondary outcome measures include change in NPI‐Q total score, Global Impression of Change, adverse events, medication cost, discontinuation of per‐protocol medication, and changes in anxiety, depression, apathy, or sleep (NPI‐Q sub scores).ResultAmong 49 participants (mean age 75.2, SD 8.3) enrolled into the study to date (24 pimavanserin, 25 quetiapine), 41 (83.7%) have PD and 8 (16.3%) have DLB; 19 (38.8%) are women; 20 (40.8%) identify as Hispanic, reflective of the clinic population; and 2 have been lost to follow‐up (1 death, 1 withdrew after moving).ConclusionPragmatic clinical trials are feasible for patients with psychosis due to LBD. The pragmatic clinical trial model can ease recruitment and retention issues and increase representation of underrepresented minorities to reflect the clinic population.
- Research Article
- 10.1016/j.pec.2025.109339
- Dec 1, 2025
- Patient education and counseling
- Jolyn Hersch + 8 more
Interventions to support patient decision making about taking part in health research: A systematic review.