This work was supported through the generosity of Close the Gap, a Boston Scientific initiative.

Akhabue, E., Kuhrt, N., Gandhi, P., Rua, M., Shalmon, U., Visaria, A., Jackson, L. R., 2nd, & Setoguchi, S. (2023). Racial differences in setting of implantable cardioverter-defibrillator placement in older adults with heart failure and association with disparate post-implant outcomes. Front Cardiovasc Med, 10, 1197353. https://doi.org/10.3389/fcvm.2023.1197353

            BACKGROUND: Implantable cardioverter-defibrillator (ICD) placement in heart failure (HF) patients during or early after (</=90 days) unplanned cardiovascular hospitalizations has been associated with poor outcomes. Racial and ethnic differences in this "peri-hospitalization" ICD placement have not been well described. METHODS: Using a 20% random sample of Medicare beneficiaries, we identified older (>/=66 years) patients with HF who underwent ICD placement for primary prevention from 2008 to 2018. We investigated racial and ethnic differences in frequency of peri-hospitalization ICD placement using modified Poisson regression. We utilized Kaplan-Meier analyses and Cox regression to investigate the association of peri-hospitalization ICD placement with differences in all-cause mortality and hospitalization (HF, cardiovascular and all-cause) within and between race and ethnicity groups for up to 5-year follow-up. RESULTS: Among the 61,710 beneficiaries receiving ICDs (35% female, 82% White, 10% Black, 6% Hispanic), 44% were implanted peri-hospitalization. Black [adjusted rate ratio (RR) 95% Confidence Interval (95% CI): 1.16 (1.12, 1.20)] and Hispanic [RR (95% CI): 1.10 (1.06, 1.14)] beneficiaries were more likely than White beneficiaries to have ICD placement peri-hospitalization. Peri-hospitalization ICD placement was associated with an at least 1.5x increased risk of death, 1.5x increased risk of re-hospitalization and 1.7x increased risk of HF hospitalization during 3-year follow-up in fully adjusted models. Although beneficiaries with peri-hospitalization placement had the highest mortality and readmission rates 1- and 3-year post-implant (log-rank p < 0.0001), the magnitude of the associated risk did not differ significantly by race and ethnicity (p = NS for interaction). CONCLUSIONS: ICD implantation occurring during the peri-hospitalization period was associated with worse prognosis and occurred at higher rates among Black and Hispanic compared to White Medicare beneficiaries with HF during the period under study. The risk associated with peri-hospitalization ICD placement did not differ by race and ethnicity. Future paradigms aimed at enhancing real-world effectiveness of ICD therapy and addressing disparate outcomes should consider timing and setting of ICD placement in HFrEF patients who otherwise meet guideline eligibility.

Alli, O. O., Garg, J., Boursiquot, B. C., Kapadia, S. R., Yeh, R. W., Price, M. J., Piccini, J. P., Nair, D. G., Hsu, J. C., Gibson, D. N., Allocco, D., Christen, T., Sutton, B., & Freeman, J. V. (2024). Racial and Ethnic Disparities in the Use and Outcomes With WATCHMAN FLX: A SURPASS Analysis of the NCDR Left Atrial Appendage Occlusion Registry. J Am Heart Assoc, 13(23), e036406. https://doi.org/10.1161/JAHA.124.036406

            BACKGROUND: Left atrial appendage occlusion (LAAO) is increasingly used as an alternative to oral anticoagulation for stroke prevention in select patients with atrial fibrillation. Data on outcomes in racial and ethnic minority individuals are limited. This analysis assessed differences in the use and outcomes of LAAO by race and ethnicity in a large national registry. METHODS AND RESULTS: This analysis acquired data on patients who underwent WATCHMAN FLX implantation from the retrospective NCDR (National Cardiovascular Data Registry) LAAO registry through September 2022. All patients with an attempted WATCHMAN FLX implantation and known race and ethnicity were included. Baseline characteristics and 1-year event rates were compared. A total of 97 185 patients were analyzed; 87 339 were White individuals (90%), 3750 Black individuals (3.9%), and 2866 Hispanic individuals (Hispanic/Latinx), 2.9%). Black and Hispanic patients were younger, with a higher incidence of prior stroke and significant bleeding compared with White patients. Black and Hispanic patients were treated with LAAO in smaller numbers relative to their proportion of the US population. Rates of procedural success were similar between groups. Though direct oral anticoagulants were prescribed in most patients across the groups, dual and single antiplatelet therapy were prescribed more often in Black patients. Black patients had significantly higher rates of 1-year death and bleeding compared with White and Hispanic patients. CONCLUSIONS: Patients from racial and ethnic minority groups comprise a disproportionately small fraction of all patients who undergo LAAO. Black and Hispanic patients were younger but had significantly higher comorbidities compared with White patients. Procedural success was similar among the groups, but Black patients experienced higher rates of death and bleeding at 1 year.

Anaba, U., Ishola, A., Alabre, A., Bui, A., Prince, M., Okafor, H., Kola-Kehinde, O., Joseph, J. J., Mitchell, D., Odei, B. C., Uzendu, A., Williams, K. P., Capers, Q., & Addison, D. (2022). Diversity in modern heart failure trials: Where are we, and where are we going. International Journal of Cardiology, 348, 95-101. https://doi.org/10.1016/j.ijcard.2021.12.018

                Over the last three decades, increased attention has been given to the representation of historically underrepresented groups within the landscape of pivotal clinical trials. However, recent events (i.e., coronavirus pandemic) have laid bare the potential continuation of historic inequities in available clinical trials and studies aimed at the care of broad patient populations. Anecdotally, cardiovascular disease (CVD) has not been immune to these disparities. Within this review, we examine and discuss recent landmark CVD trials, with a specific focus on the representation of Blacks within several critically foundational heart failure clinical trials tied to contemporary treatment strategies and drug approvals. We also discuss solutions for inequities within the landscape of cardiovascular trials. Building a more diverse clinical trial workforce coupled with intentional efforts to increase clinical trial diversity will advance equity in cardiovascular care.

Azam, T. U., & Colvin, M. M. (2021). Representation of Black patients in heart failure clinical trials. Current Opinion in Cardiology, 36(3), 329-334. https://doi.org/10.1097/hco.0000000000000849

            Purpose of review. Black patients with heart failure in the United States are underrepresented in clinical trials relative to their overrepresentation in the heart failure population and in adverse heart failure outcomes. We aim to evaluate historical trends in this space and highlight recent developments.

Recent findings. Multiple landmark heart failure trials published since 2019 have underrepresented Black patients, though several discussed this lack of representation as limitations. A review of large heart failure clinical trials from 2001 to 2016 found persistent underrepresentation of Black patients without significant change over time. Trials enrolling from North America exclusively had more proportional representation, enrolling an average of 31.6% Black participants.

Summary. There is a shrinking proportion of Black patients in pivotal heart failure trials despite a higher prevalence of disease and associated adverse outcomes. There is increasing awareness of these disparities within the heart failure community, potentially leading to improved representation in future studies.

Balban, M. Y., Neri, E., Kogon, M. M., Weed, L., Nouriani, B., Jo, B., Holl, G., Zeitzer, J. M., Spiegel, D., & Huberman, A. D. (2023). Brief structured respiration practices enhance mood and reduce physiological arousal. Cell Rep Med, 4(1), 100895. https://doi.org/10.1016/j.xcrm.2022.100895

            Controlled breathwork practices have emerged as potential tools for stress management and well-being. Here, we report a remote, randomized, controlled study (NCT05304000) of three different daily 5-min breathwork exercises compared with an equivalent period of mindfulness meditation over 1 month. The breathing conditions are (1) cyclic sighing, which emphasizes prolonged exhalations; (2) box breathing, which is equal duration of inhalations, breath retentions, and exhalations; and (3) cyclic hyperventilation with retention, with longer inhalations and shorter exhalations. The primary endpoints are improvement in mood and anxiety as well as reduced physiological arousal (respiratory rate, heart rate, and heart rate variability). Using a mixed-effects model, we show that breathwork, especially the exhale-focused cyclic sighing, produces greater improvement in mood (p < 0.05) and reduction in respiratory rate (p < 0.05) compared with mindfulness meditation. Daily 5-min cyclic sighing has promise as an effective stress management exercise.

Berg, J. M., Celedón, J. C., & Jonassaint, N. N. (2023). Validating an approach for estimating appropriate Black participation in clinical trials. medRxiv. https://doi.org/10.1101/2023.07.24.23293100

            Representation of different groups at appropriate levels in clinical trials is of great importance. Factors affecting what appropriate levels include the demographics at the trial sites and the prevalence of the condition under study in different populations. We examined 359 trials published in New England Journal of Medicine, Journal of the American Medical Association (JAMA), and the Lancet in 2020 for information about Black participation rates. Sufficient information for analysis was available in 58 trials. Simulations including both site demographics and prevalence factors revealed that observed Black participation rates were reasonably well correlated with estimated potential Black participation rates, but that actual participation rates were lower than potential rates in 47 out of 58 trials. This approach could be used to estimate appropriate participation rates prior to trial initiation and for analysis of trials upon completion. Promotion of such transparency standards will aid future analyses and should help drive improvements in representation over time.

Berkman, A. M., Andersen, C. R., Roth, M. E., & Gilchrist, S. C. (2022). Cardiovascular disease in adolescent and young adult cancer survivors: Impact of sociodemographic and modifiable risk factors. Cancer, 129(3), 450-460. https://doi.org/10.1002/cncr.34505

            BACKGROUND: There is a growing population of adolescent and young adult (AYA) cancer survivors (ages 15-39 years), and they have an elevated risk of developing cardiovascular disease (CVD). Little is known about the contribution of sociodemographic and modifiable factors to the risk of CVD in AYA survivors and whether these factors differentially modulate their risk compared with that in the general population. The current study sought to fill these gaps. METHODS: Self-reported data from the US National Health Interview Survey (2009-2018) were used to identify AYA cancer survivors (>/=2 years postdiagnosis) and age-matched and sex-matched controls. The risk of CVD based on sociodemographic factors (sex, race/ethnicity, income, education) and modifiable risk factors (diabetes, body mass index, smoking, physical activity) was determined within and between survivors and controls using logistic regression models. RESULTS: In total, 4766 AYA cancer survivors and 47,660 controls were included. The odds of CVD were significantly higher in survivors than in controls by sex, race/ethnicity, income, education, smoking status, and physical activity. An annual household income <$50,000 disproportionately increased the odds of CVD in survivors. One third of survivors reported no moderate-to-vigorous-intensity physical activity (MVPA). Performing any MVPA lowered the odds of CVD in survivors (odds ratio, 0.61; 95% CI, 0.450.81) and controls (odds ratio, 0.68; 95% CI, 0.61-0.77). CONCLUSIONS: Sociodemographic and modifiable risk factors increased the odds of CVD in AYA survivors, in some cases disproportionately, compared with controls. Understanding health behavior trajectories among different sociodemographic populations is needed to identify opportunities to lower the risk of CVD. Performing any MVPA is particularly important for AYA survivors.

Berkowitz, S. T., Groth, S. L., Gangaputra, S., & Patel, S. (2021). Racial/Ethnic Disparities in Ophthalmology Clinical Trials Resulting in US Food and Drug Administration Drug Approvals From 2000 to 2020. JAMA Ophthalmology, 139(6), 629-637. https://doi.org/10.1001/jamaophthalmol.2021.0857

Borja-Montes, O. F., Bode, A., Escobar-Gil, T., Toro-Pedroza, A., Epperla, N., & Andritsos, L. A. (2025). Gender Disparity in Enrollment in Clinical Trials for Hairy Cell Leukemia Treatments in the Last 40 Years. EJHaem, 6(3), e70065. https://doi.org/10.1002/jha2.70065

            BACKGROUND: Hairy Cell Leukemia (HCL) is a B-cell lymphoproliferative disorder that predominantly affects males, yet recent evidence suggests a notable gender participation gap in HCL clinical trials. This study aims to characterize that disparity and explore potential factors contributing to the under-enrollment of females. METHODS: In this descriptive, retrospective study, we searched EMBASE, PUBMED, Cochrane Central, and ClinicalTrials.gov from January 1983 to December 2023 for publications on clinical trials (CT) in HCL, descriptive statistical analysis of all the sociodemographic variables was performed. RESULTS: We analyzed 57 clinical trials totaling 4595 HCL patients, with 79.1% male and 20.9% female participants. The male-to-female ratio declined from 5.91 (1983-1993) to 4.19 (2014-2023). Although the gender gap narrowed over time, female participation slightly decreased to 19.2% in the most recent period (2014-2023). CONCLUSIONS: Female enrollment in HCL clinical trials remains disproportionately low compared to incidence rates, underscoring the need to address underlying barriers to improve equity in clinical research and treatment outcomes. TRIAL REGISTRATION: The authors have confirmed clinical trial registration is not needed for this submission.

Bowe, T., Salabati, M., Soares, R. R., Huang, C., Singh, R. P., Khan, M. A., Williams, B. K., Jr., Sridhar, J., Chiang, A., Cohen, M. N., Klufas, M. A., Gupta, O. P., Yonekawa, Y., Xu, D., & Kuriyan, A. E. (2022). Racial, Ethnic, and Gender Disparities in Diabetic Macular Edema Clinical Trials. Ophthalmol Retina, 6(6), 531-533. https://doi.org/10.1016/j.oret.2022.01.018

            Subjects in diabetic macular edema clinical trials in the United States are disproportionately White and male, compared with the population undergoing treatment for diabetic macular edema.

Bruch, J. D., Khazen, M., Mahmic-Kaknjo, M., Legare, F., & Ellen, M. E. (2024). The effects of shared decision making on health outcomes, health care quality, cost, and consultation time: An umbrella review. Patient Educ Couns, 129, 108408. https://doi.org/10.1016/j.pec.2024.108408

            OBJECTIVE: To review the effects of shared decision making (SDM) on health outcomes, health care quality, cost, and consultation time METHODS: We conducted an umbrella review and searched systematic reviews on SDM from PubMed, CINHAL, and Web of Science. We included reviews on SDM interventions used in a health care setting with patients. We assessed the eligibility of retrieved articles and evaluated whether the review addressed Consolidated Framework for Implementation Research (CFIR) characteristics. RESULTS: Out of 3678 records, 48 reviews were included. Half of the reviews focused exclusively on RCT studies (n = 21). A little less than half were focused specifically on decision aids (n = 23). Thirty-two reviews discussed CFIR characteristics explicitly or implicitly; the majority of which were specific to intervention characteristics. Reviews tended to cluster around patient populations and tended to be low or critically low to moderate in their quality. Reviews of SDM on health outcomes, health care quality, cost, and consultation time were highly uncertain but often ranged from neutral to positive. CONCLUSIONS: We observed that SDM implementation did not typically increase costs or increase consultation time while having some neutral to positive benefits on outcomes and quality for certain populations. Gaps in knowledge remain including better research on the climate where SDM is most effective.

Buffenstein, I., Kaneakua, B., Taylor, E., Matsunaga, M., Choi, S. Y., Carrazana, E., Viereck, J., Liow, K. K., & Ghaffari-Rafi, A. (2023). Demographic recruitment bias of adults in United States randomized clinical trials by disease categories between 2008 to 2019: a systematic review and meta-analysis. Scientific Reports, 13(1), 42. https://doi.org/10.1038/s41598-022-23664-1

            To promote health equity within the United States (US), randomized clinical trials should strive for unbiased representation. Thus, there is impetus to identify demographic disparities overall and by disease category in US clinical trial recruitment, by trial phase, level of masking, and multi-center status, relative to national demographics. A systematic review and meta-analysis were conducted using MEDLINE, Embase, CENTRAL, and ClinicalTrials.gov, between 01/01/2008 to 12/30/2019. Clinical trials (N = 5,388) were identified based on the following inclusion criteria: study type, location, phase, and participant age. Each clinical trial was independently screened by two researchers. Data was pooled using a random-effects model. Median proportions for gender, race, and ethnicity of each trial were compared to the 2010 US Census proportions, matched by age. A second analysis was performed comparing gender, race, and ethnicity proportions by trial phase, multi-institutional status, quality, masking, and study start year. 2977 trials met inclusion criteria (participants, n=607,181) for data extraction. 36% of trials reported ethnicity and 53% reported race. Three trials (0.10%) included transgender participants (n=5). Compared with 2010 US Census data, females (48.3%, 95% CI 47.2–49.3, p<0.0001), Hispanics (11.6%, 95% CI 10.8–12.4, p<0.0001), American Indians and Alaskan Natives (AIAN, 0.19%, 95% CI 0.15–0.23, p<0.0001), Asians (1.27%, 95% CI 1.13–1.42, p<0.0001), Whites (77.6%, 95% CI 76.4–78.8, p<0.0001), and multiracial participants (0.25%, 95% CI 0.21–0.31, p<0.0001) were under-represented, while Native Hawaiians and Pacific Islanders (0.76%, 95% CI 0.71–0.82, p<0.0001) and Blacks (17.0%, 95% CI 15.9–18.1, p<0.0001) were over-represented. Inequitable representation was mirrored in analysis by phase, institutional status, quality assessment, and level of masking. Between 2008 to 2019 representation improved for only females and Hispanics. Analysis stratified by 44 disease categories (i.e., psychiatric, obstetric, neurological, etc.) exhibited significant yet varied disparities, with Asians, AIAN, and multiracial individuals the most under-represented. These results demonstrate disparities in US randomized clinical trial recruitment between 2008 to 2019, with the reporting of demographic data and representation of most minorities not having improved over time.

Buhle, J. T., Silvers, J. A., Wager, T. D., Lopez, R., Onyemekwu, C., Kober, H., Weber, J., & Ochsner, K. N. (2014). Cognitive reappraisal of emotion: a meta-analysis of human neuroimaging studies. Cereb Cortex, 24(11), 2981-2990. https://doi.org/10.1093/cercor/bht154

            In recent years, an explosion of neuroimaging studies has examined cognitive reappraisal, an emotion regulation strategy that involves changing the way one thinks about a stimulus in order to change its affective impact. Existing models broadly agree that reappraisal recruits frontal and parietal control regions to modulate emotional responding in the amygdala, but they offer competing visions of how this is accomplished. One view holds that control regions engage ventromedial prefrontal cortex (vmPFC), an area associated with fear extinction, that in turn modulates amygdala responses. An alternative view is that control regions modulate semantic representations in lateral temporal cortex that indirectly influence emotion-related responses in the amygdala. Furthermore, while previous work has emphasized the amygdala, whether reappraisal influences other regions implicated in emotional responding remains unknown. To resolve these questions, we performed a meta-analysis of 48 neuroimaging studies of reappraisal, most involving downregulation of negative affect. Reappraisal consistently 1) activated cognitive control regions and lateral temporal cortex, but not vmPFC, and 2) modulated the bilateral amygdala, but no other brain regions. This suggests that reappraisal involves the use of cognitive control to modulate semantic representations of an emotional stimulus, and these altered representations in turn attenuate activity in the amygdala.

Burgess, D. J., Beach, M. C., & Saha, S. (2017). Mindfulness practice: A promising approach to reducing the effects of clinician implicit bias on patients. Patient Educ Couns, 100(2), 372-376. https://doi.org/10.1016/j.pec.2016.09.005

            Like the population at large, health care providers hold implicit racial and ethnic biases that may contribute to health care disparities. Little progress has been made in identifying and implementing effective strategies to address these normal but potentially harmful unconscious cognitive processes. We propose that meditation training designed to increase healthcare providers' mindfulness skills is a promising and potentially sustainable way to address this problem. Emerging evidence suggests that mindfulness practice can reduce the provider contribution to healthcare disparities through several mechanisms including: reducing the likelihood that implicit biases will be activated in the mind, increasing providers' awareness of and ability to control responses to implicit biases once activated, increasing self-compassion and compassion toward patients, and reducing internal sources of cognitive load (e.g., stress, burnout, and compassion fatigue). Mindfulness training may also have advantages over current approaches to addressing implicit bias because it focuses on the development of skills through practice, promotes a nonjudgmental approach, can circumvent resistance some providers feel when directly confronted with evidence of racism, and constitutes a holistic approach to promoting providers' well-being. We close with suggestions for how a mindfulness approach can be practically implemented and identify potential challenges and research gaps to be addressed.

Center for, I., & Study on Clinical Research, P. (2023). 2023 Perceptions & Insights Study: Demographic breakdown in clinical trial respondents. https://pmc.ncbi.nlm.nih.gov/articles/PMC12018620/.

            Importance, Racially and ethnically diverse, equitable representation among clinical trial participants is important for enhancing the drug development process and promoting equitable healthcare outcomes.

Objective.  To understand the barriers and drivers for inclusive clinical trials, focusing on the attitudes, perceptions, experiences, and challenges faced by underrepresented populations.

Design. An online questionnaire was administered online from April to June 2023 and involved 12,017 respondents from 54 countries. This survey utilized a convenience sampling strategy. Statistical analysis was performed to compare responses among racial and ethnic groups.

Setting. The study was conducted globally. Survey respondents were recruited through various patient recruitment organizations, patient advocacy groups, and contract research organizations.

Respondents. Adults 18 years or older who received an email or had online access were eligible to participate. Racial and ethnic composition included White (81%), Hispanic/Latino (15%), Black/African American (6%), Asian (6%), and other ethnicities.

Exposure(s). Respondents were asked about their perceptions, concerns and experiences related to clinical research access and participation.

Main Outcome(s) and Measure(s). Key outcomes included barriers to clinical research participation, factors influencing trust in pharmaceutical companies and past experiences.

Results. Barriers to clinical research participation varied among ethnic groups. Asian respondents cited concerns about time off work (22%) and time required to participate (19%) more frequently as compared to White respondents (7% and 7%, respectively; p < 0.05). Hispanics expressed higher concerns about time off work (15%) and receiving placebo (10%) as compared to Non-Hispanics (8% and 5%, respectively, p < 0.05). Black and Hispanic respondents placed higher importance on diversity in staff compared to White and non-Hispanic respondents (B: 32%; W: 12%; Hispanic: 22%; Non-Hispanic: 13% p < 0.05). Black, Asian, and Hispanic respondents reported higher levels of disruption in participation related to technology use (Black: 31%; Hispanic: 30%; Asian: 29%) and completing study requirements at home (Black: 32%; Hispanic: 30%; Asian: 26%) as compared to White (13%, 15%; p < 0.05%) and non-Hispanic respondents (14%, 17%; p < 0.05). Conclusions. The findings highlight the need to address barriers to diversity in clinical trials and improve trial experiences of underrepresented communities, facilitating design of more inclusive and patient-centered trials.

Chen, H., Emechebe, N., Karve, S., Raskin, L., Leal, J., Cheng, N., Sebby, W., Ribeiro, K., & Crawford, S. (2025). Demographic clinical trial diversity assessment methods: Use of real-world data. Contemp Clin Trials Commun, 44, 101432. https://doi.org/10.1016/j.conctc.2025.101432

            Diversity in clinical trials is defined by the inclusion of clinical trial participants from various demographic groups that are representative of the broader population impacted by a disease state. Diversity in clinical trials is critical in identifying potential differences in safety and efficacy of treatments across races, ethnicities, ages, sexes, or other variables. In the United States, clinical trial diversity is often benchmarked against US Census data, which may limit the representativeness of patient demographics in clinical trials. Disease-specific, demographic estimates from real-world data (RWD) can facilitate benchmarking of clinical trials, support trial enrollment and the development of trial diversity plans. Notably, development and dissemination of these estimates from RWD can be challenging without a standardized process. To address this issue, we developed a new evaluation framework to assess patient demographics and characteristics within specific disease populations using RWD and disease population estimates. Suitable databases were identified using predefined criteria such as accessibility to patient-level data, availability of all demographic variables of interest, sufficient sample size of the disease population, and availability of population weights to enhance generalizability. Concurrent data were gathered via targeted literature reviews for each disease condition. Together, this data was used to create disease-specific, demographic estimate profiles to inform diverse enrollment goals for prospective clinical trials. We present two examples of application of this framework to illustrate the results in the case of two disease states, rheumatoid arthritis and stroke.

Chuzi, S., Ahmad, F. S., Wu, T., Argaw, S., Harap, R., Grady, K. L., Rich, J. D., Pham, D. T., Khan, S. S., Wilcox, J. E., Allen, L. A., & Tibrewala, A. (2022). Time Spent Engaging in Health Care Among Patients With Left Ventricular Assist Devices. JACC: Heart Failure, 10(5), 321-332. https://doi.org/10.1016/j.jchf.2022.01.011

            Objectives

This study aims to examine a novel patient-centered metric of time spent engaging in left ventricular assist device (LVAD)–related clinical care outside the home.

Background. Although LVAD implantation can improve survival and functional capacity in patients with advanced heart failure, this may occur at the expense of significant time spent engaging in LVAD-related health care activities.

Methods. The authors retrospectively assessed consecutive patients at a single center who received a continuous-flow LVAD between May 9, 2008, and December 31, 2019, and queried health care encounters after implantation, including all inpatient encounters and LVAD-related ambulatory encounters. Patient-level time metrics were determined, including the total number of days with any health care encounter, and the total estimated time spent receiving care. The primary outcome was the proportion (%) of days alive with an LVAD spent engaged in at least 1 health care encounter. The secondary outcome was the proportion (%) of total time alive with an LVAD spent receiving care.

Results. Among 373 patients, the median number of days alive with LVAD was 390 (IQR: 158-840 days). Patients had a median number of 88 (IQR: 45-161) days with ≥1 health care encounter, accounting for 23.2% (IQR: 16.3%-32.4%) of their days alive with an LVAD. A median 6.0% (IQR: 2.1%-14.1%) and 15.0% (IQR: 10.7%-20.0%) of total days alive were spent in inpatient and ambulatory encounters, respectively. Patients spent a median of 592 (IQR: 197-1,257) hours receiving care, accounting for 5.6% (IQR: 2.2%-12.7%) of their total time alive with an LVAD.

Conclusions. LVAD patients spent more than 1 of every 5 days engaging in health care. Our findings may inform strategies to improve efficiency of postdischarge care delivery and expectations for post-treatment care.

Cikara, M., Van Bavel, J. J., Ingbretsen, Z. A., & Lau, T. (2017). Decoding "us" and "them": Neural representations of generalized group concepts. J Exp Psychol Gen, 146(5), 621-631. https://doi.org/10.1037/xge0000287

            Humans form social coalitions in every society on earth, yet we know very little about how the general concepts us and them are represented in the brain. Evolutionary psychologists have argued that the human capacity for group affiliation is a byproduct of adaptations that evolved for tracking coalitions in general. These theories suggest that humans possess a common neural code for the concepts in-group and out-group, regardless of the category by which group boundaries are instantiated. The authors used multivoxel pattern analysis to identify the neural substrates of generalized group concept representations. They trained a classifier to encode how people represented the most basic instantiation of a specific social group (i.e., arbitrary teams created in the lab with no history of interaction or associated stereotypes) and tested how well the neural data decoded membership along an objectively orthogonal, real-world category (i.e., political parties). The dorsal anterior cingulate cortex/middle cingulate cortex and anterior insula were associated with representing groups across multiple social categories. Restricting the analyses to these regions in a separate sample of participants performing an explicit categorization task, the authors replicated cross-categorization classification in anterior insula. Classification accuracy across categories was driven predominantly by the correct categorization of in-group targets, consistent with theories indicating in-group preference is more central than out-group derogation to group perception and cognition. These findings highlight the extent to which social group concepts rely on domain-general circuitry associated with encoding stimuli's functional significance. (PsycINFO Database Record.

Clark, L. T., Watkins, L., Pina, I. L., Elmer, M., Akinboboye, O., Gorham, M., Jamerson, B., McCullough, C., Pierre, C., Polis, A. B., Puckrein, G., & Regnante, J. M. (2019). Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Curr Probl Cardiol, 44(5), 148-172. https://doi.org/10.1016/j.cpcardiol.2018.11.002

            Clinical trial results provide the critical evidence base for evaluating the safety and efficacy of new medicines and medical products. Efficacy and safety may differ among population subgroups depending on intrinsic/extrinsic factors, including sex, age, race, ethnicity, lifestyle, and genetic background. Racial and ethnic minorities continue to be underrepresented in cardiovascular and other clinical trials. Although barriers to diversity in trials are well recognized, sustainable solutions for overcoming them have proved elusive. We investigated barriers impacting minority patients' willingness to participate in trials and-based on literature review and evaluation, and input from key stakeholders, including minority patients, referring physicians, investigators who were minority-serving physicians, and trial coordinators-formulated potential solutions and tested them across stakeholder groups. We identified key themes from solutions that resonated with stakeholders using a transtheoretical model of behavior change and created a communications message map to support a multistakeholder approach for overcoming critical participant barriers.

Deyell, M. W., Leather, R. A., Macle, L., Forman, J., Khairy, P., Zhang, R., Ding, L., Chakrabarti, S., Yeung-Lai-Wah, J. A., Lane, C., Novak, P. G., Sterns, L. D., Bennett, M. T., Laksman, Z. W., Sikkel, M. B., & Andrade, J. G. (2020). Efficacy and Safety of Same-Day Discharge for Atrial Fibrillation Ablation. JACC Clin Electrophysiol, 6(6), 609-619. https://doi.org/10.1016/j.jacep.2020.02.009

            OBJECTIVES: The purpose of this study was to evaluate the efficacy, health care utilization, and safety of a same-day discharge protocol. BACKGROUND: Catheter ablation of atrial fibrillation (AF) is the most common ablation performed. Increasing volumes of AF ablation are placing demands on hospital resources. In response, our institutions developed a same-day discharge protocol for AF ablation. METHODS: This was a multicenter cohort study of all patients undergoing AF ablation from 2010 to 2014 at 2 major centers. The primary efficacy outcome was the proportion of successful same-day discharges. The primary health care utilization outcome was 30-day hospital readmission for any reason. The primary safety outcome was a composite of 30-day death, stroke/transient ischemic attack or embolism, or bleeding requiring hospitalization. RESULTS: A total of 3,054 patients underwent AF ablation from 2010 to 2014 and met inclusion criteria. Same-day discharge was achieved in 79.2% (2,418 of 3,054). Hospital readmission at 30 days was 7.7% for the same-day discharge group, 10.2% for those who remained in the hospital overnight without complications (p = 0.055 for comparison with same-day discharge), and 19.5% (p < 0.001) for those who remained in the hospital with procedural complications (7.7%). Complication rates from discharge to 30 days (excluding immediate procedural complications) were 0.37% for the same-day discharge group, 0.36% (p = 0.999) for those kept overnight without complications, and 2.5% (p = 0.044) for those with initial procedural complications. CONCLUSIONS: Same-day discharge after AF ablation is feasible in the majority of patients with use of a standardized protocol. This approach was not associated with higher hospital readmission or complication rates after discharge.

Dixon, D. D., Knapp, S. M., Ilonze, O., Lewsey, S. C., Mazimba, S., Mohammed, S., Van Spall, H. G. C., & Breathett, K. (2023). Racial and Ethnic Disparities in Ambulatory Heart Failure Ventricular Assist Device Implantation and Survival. JACC Heart Fail, 11(10), 1397-1407. https://doi.org/10.1016/j.jchf.2023.05.017

            BACKGROUND: Durable left ventricular assist devices (VADs) improve survival in eligible patients, but allocation has been associated with patient race in addition to presumed heart failure (HF) severity. OBJECTIVES: This study sought to determine racial and ethnic differences in VAD implantation rates and post-VAD survival among patients with ambulatory HF. METHODS: Using the INTERMACS (Interagency Registry of Mechanically Assisted Circulatory Support) database (2012-2017), this study examined census-adjusted VAD implantation rates by race, ethnicity, and sex in patients with ambulatory HF (INTERMACS profile 4-7) using negative binomial models with quadratic effect of time. Survival was evaluated using Kaplan-Meier estimates and Cox models adjusted for clinically relevant variables and an interaction of time with race/ethnicity. RESULTS: VADs were implanted in 2,256 adult patients with ambulatory HF (78.3% White, 16.4% Black, and 5.3% Hispanic). The median age at implantation was lowest in Black patients. Implantation rates peaked between 2013 and 2015 before declining in all demographic groups. From 2012 to 2017, implantation rates overlapped for Black and White patients but were lower for Hispanic patients. Post-VAD survival was significantly different among the 3 groups (log rank P = 0.0067), with higher estimated survival among Black vs White patients (12-month survival: Black patients: 90% [95% CI: 86%-93%]; White patients: 82% [95% CI: 80%-84%]). Low sample size for Hispanic patients resulted in imprecise survival estimates (12-month survival: 85% [95% CI: 76%-90%]). CONCLUSIONS: Black and White patients with ambulatory HF had similar VAD implantation rates but rates were lower for Hispanic patients. Survival differed among the 3 groups, with the highest estimated survival at 12 months in Black patients. Given higher HF burden in minoritized populations, further investigation is needed to understand differences in VAD implantation rates in Black and Hispanic patients.

Domínguez-Alonso, C., López-Gutiérrez, A., & Arranz-Obispo, C. (2024). Gender disparity in enrollment in hairy cell leukemia clinical trials (1983–2023). Blood Advances, 8(12), 2430-2438. https://doi.org/10.1182/bloodadvances.2023009889

Epstein, N. K., Harpaz, M., Abo-Molhem, M., Yehuda, D., Tau, N., & Yahav, D. (2024). Women's Representation in RCTs Evaluating FDA-Supervised Medical Devices: A Systematic Review. JAMA Intern Med, 184(8), 977-979. https://doi.org/10.1001/jamainternmed.2024.1011

            This systematic review evaluates the representation of women in randomized clinical trials (RCTs) of US Food and Drug Administration (FDA)-supervised medical devices.

Fainstad, T. L., McClintock, A. H., & Yarris, L. M. (2021). Bias in assessment: name, reframe, and check in. Clin Teach, 18(5), 449-453. https://doi.org/10.1111/tct.13351

            Cognitive bias permeates almost every learner assessment in medical education. Assessment bias has the potential to affect a learner's education, future career and sense of self-worth. Decades of data show that there is little educators can do to overcome bias in learner assessments. Using in-group favouritism as an example, we offer an evidence-based, three-step solution to understand and move forward with cognitive bias in assessment: (1) Name: a simple admission about the presence of inherent bias in assessment, (2) Reframe: a rephrasing of assessment language to shed light on the assessor's subjectivity and (3) Check-in: a chance to ensure learner understanding and open lines of bidirectional communication. This process is theory-informed and based on decades of educational, sociological and psychological literature; we offer it as a logical first step towards a much-needed paradigm shift towards addressing bias in learner assessment.

Farrar, N., Elliott, D., Jepson, M., Young, B., Donovan, J. L., Conefrey, C., Realpe, A. X., Mills, N., Wade, J., Lim, E., Stein, R. C., Caskey, F. J., & Rooshenas, L. (2024). The role of healthcare professionals' communication in trial participation decisions: a qualitative investigation of recruitment consultations and patient interviews across three RCTs. Trials, 25(1), 829. https://doi.org/10.1186/s13063-024-08656-y

            BACKGROUND: Although the challenges of recruiting to randomised controlled trials (RCTs) are well documented, few studies have focused on the impact that the communication between recruiters and patients has on patients' participation decisions. Recruiters are thought to influence patient decision-making, but the mechanisms by which this occurs are unclear. The aim of this research was to investigate how patients interpret and use the information conveyed to them by healthcare professionals (HCPs) in trial participation decisions. METHODS: Three pragmatic UK-based multicentre RCTs were purposively sampled to provide contrasting clinical specialities. Data collection was integrated into each RCT, including audio-recordings of patient recruitment consultations and interviews with patients. Where possible, consultation audio-recordings were linked to interviews to explore how information communicated by recruiters was interpreted and used by patients during their decision-making. Data were analysed thematically, using the constant comparison approach. RESULTS: Twenty audio-recorded recruitment consultations were obtained across the 3 RCTs, combined with 42 interviews with patients who had consented to or declined RCT participation. Consultation and interview data were 'linked' for 17 individual patients. Throughout the patient's clinical pathway, HCPs (both those involved in the RCT and not) influenced patients' perceptions of treatment need and benefit by indicating that they preferred a particular treatment option for the patient as an individual. Whilst patients valued and were influenced by information conveyed by HCPs, they also drew on support from other sources and ultimately framed RCT participation decisions as their own. Patients' willingness to be randomised hinged on perceptions of whether they stood to benefit from a particular treatment and the availability of those treatments outside of the trial. CONCLUSION: This study supports the need for training and support for healthcare professionals involved throughout the clinical pathway of patients eligible for RCTs, as all healthcare professionals who interact with patients have the potential to influence their perceptions of treatments being compared in the trial. TRIAL REGISTRATION: OPTIMA ISRCTN42400492. Prospectively registered on 26 June 2012. Prepare for Kidney Care ISRCTN17133653. Prospectively registered on 31 May 2017. MARS 2 ISRCTN44351742. Retrospectively registered on 5 September 2018.

Flores, L. E., Frontera, W. R., Andrasik, M. P., Del Rio, C., Mondriguez-Gonzalez, A., Price, S. A., Krantz, E. M., Pergam, S. A., & Silver, J. K. (2021). Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials. JAMA Netw Open, 4(2), e2037640. https://doi.org/10.1001/jamanetworkopen.2020.37640

            IMPORTANCE: Medical research has not equitably included members of racial/ethnic minority groups or female and older individuals. There are limited data on participant demographic characteristics in vaccine trials despite the importance of these data to current trials aimed at preventing coronavirus disease 2019. OBJECTIVE: To investigate whether racial/ethnic minority groups and female and older adults are underrepresented among participants in vaccine clinical trials. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study examined data from completed US-based vaccine trials registered on ClinicalTrials.gov from July 1, 2011, through June 30, 2020. The terms vaccine, vaccination, immunization, and inoculation were used to identify trials. Only those addressing vaccine immunogenicity or efficacy of preventative vaccines were included. MAIN OUTCOMES AND MEASURES: The numbers and percentages of racial/ethnic minority, female, and older individuals compared with US census data from 2011 and 2018. Secondary outcome measures were inclusion by trial phase and year of completion. RESULTS: A total of 230 US-based trials with 219 555 participants were included in the study. Most trials were randomized (180 [78.3%]), included viral vaccinations (159 [69.1%]), and represented all trial phases. Every trial reported age and sex; 134 (58.3%) reported race and 79 (34.3%) reported ethnicity. Overall, among adult study participants, White individuals were overrepresented (77.9%; 95% CI, 77.4%-78.4%), and Black or African American individuals (10.6%; 95% CI, 10.2%-11.0%) and American Indian or Alaska Native individuals (0.4%; 95% CI, 0.3%-0.5%) were underrepresented compared with US census data; enrollment of Asian individuals was similar (5.7%; 95% CI, 5.5%-6.0%). Enrollment of Hispanic or Latino individuals (11.6%; 95% CI, 11.1%-12.0%) was also low even among the limited number of adult trials reporting ethnicity. Adult trials were composed of more female participants (75 325 [56.0%]), but among those reporting age as a percentage, enrollment of participants who were aged 65 years or older was low (12.1%; 95% CI, 12.0%-12.3%). Black or African American participants (10.1%; 95% CI, 9.7%-10.6%) and Hispanic or Latino participants (22.5%; 95% CI, 21.6%-23.4%) were also underrepresented in pediatric trials. Among trials reporting race/ethnicity, 65 (48.5%) did not include American Indian or Alaska Native participants and 81 (60.4%) did not include Hawaiian or Pacific Islander participants. CONCLUSIONS AND RELEVANCE: This cross-sectional study found that among US-based vaccine clinical trials, members of racial/ethnic minority groups and older adults were underrepresented, whereas female adults were overrepresented. These findings suggest that diversity enrollment targets should be included for all vaccine trials targeting epidemiologically important infections.

Gong, I. Y., Tan, N. S., Ali, S. H., Lebovic, G., Mamdani, M., Goodman, S. G., Ko, D. T., Laupacis, A., & Yan, A. T. (2019). Temporal Trends of Women Enrollment in Major Cardiovascular Randomized Clinical Trials. Can J Cardiol, 35(5), 653-660. https://doi.org/10.1016/j.cjca.2019.01.010

            BACKGROUND: Although it is known that women do not participate in trials as frequently as men, there are limited recent data examining how women recruitment has changed over time. METHODS: We conducted MEDLINE search using a validated strategy for randomized trials published in New England Journal of Medicine, Lancet, and Journal of the American Medical Association between 1986 and 2015, and included trials evaluating pharmacologic or nonpharmacologic therapies. We abstracted data on demographics, intervention type, clinical indication, and trial design characteristics, and examined their relationships with women enrollment. RESULTS: In total, 598 trials met inclusion criteria. Women enrollment increased significantly over time (21% between 1986 and 1990 to 33% between 2011 and 2015; P(for trend) < 0.001) and did not differ by journal or funding source. Women enrollment varied with clinical indication, comprising 37% for non-coronary artery disease vascular trials, 30% for coronary artery disease trials, 28% for heart failure trials, and 28% for arrhythmia trials (P < 0.001), which were all significantly lower than the expected proportion in disease populations (P < 0.001). Women enrollment varied with trial type (31%, 29%, and 26% for pharmacologic, device, and procedural trials, respectively; P = 0.001). These findings were corroborated using multivariable analysis. We found significant positive correlations between women enrolled, and mean age and total number of participants. Fewer women were enrolled in trials reporting statistically significant results than those who did not (P = 0.001). CONCLUSIONS: Although enrollment of women has increased over time, it remains lower than the relative proportion in the disease population. Future studies should elucidate the reasons for persistent under-representation of women in clinical trials.

Gray, D. M., 2nd, Nolan, T. S., Gregory, J., & Joseph, J. J. (2021). Diversity in clinical trials: an opportunity and imperative for community engagement. Lancet Gastroenterol Hepatol, 6(8), 605-607. https://doi.org/10.1016/S2468-1253(21)00228-4

Gupta, R., Umeh, C., Mohta, T., Vaidya, A., Wolfson, A., Nattiv, J., Bhatia, H., Kaur, G., Dhawan, R., Darji, P., Eghreriniovo, B., Sanwo, E., Hotwani, P., Mahdavian, P., Kumar, S., & Tiwari, B. (2024). Representation of women and racial minorities in SGLT2 inhibitors and heart failure clinical trials. Int J Cardiol Heart Vasc, 55, 101539. https://doi.org/10.1016/j.ijcha.2024.101539.

            BACKGROUND: Inadequate representation of women and racial minorities in heart failure (HF) clinical trials continues to limit the generalizability of the results. This could create a disparity in treatment for future heart failure therapies and devices. The study aims to assess the representation of women and racial minorities in recent heart failure studies involving sodium-glucose cotransporter-2 (SGLT-2) inhibitors. METHODS: PubMed was used to search randomized controlled trials (RCTs) looking at SGLT-2 inhibitors and heart failure, which were published from inception to August 2024. RESULTS: A total of 43 RCTs with 27,703 participants were identified. The studies were published between 2018 and 2024. Seven studies (41 %) were multi-country, with 45 countries represented. The overall proportion of women enrolled in the studies was 35.6 %. The proportion of women was 24.06 % in studies that recruited only patients with HFrEF, 44.33 % in those that recruited only patients with HFpEF, and 41.4 % in those that recruited both HFrEF and HFpEF. Data on race was partially reported in 25 studies (58 %). 76 % of the pharmaceutical industry-funded studies reported race data. However, only 33.3 % of the unfunded or non-industry-funded studies reported race data. In the studies that reported race data, 72.91 % were Caucasians, 15.48 % were Asians, 5.62 % were African-American and 4.1 % were mixed race or others.In the bivariate analysis, race was more likely to be reported in studies done in the US (p < 0.001), multi-country studies (p = 0.013), and studies sponsored by pharmaceutical companies. More than a third of the study participants were more likely to be women in more recently published studies than older studies (p < 0.001). Additionally, more than a third of the study participants were more likely to be women in studies done in the US (p = 0.055). The multivariate analysis showed an increased odds of having more than a third of the study participants being women in more recently published studies (OR 1.83, 95 % CI 1.06-3.17, p = 0.031) and in studies done in the US (OR 7.69, 95 % CI 1.53-38.59, p = 0.013). CONCLUSION: Our study found that women and racial minority individuals have remained underrepresented in recent heart failure studies. Although some progress has been made over the years, more work is needed to improve data reporting and address barriers to enrollment for women and racial minority individuals in clinical trials.

Ismayl, M., Abbasi, M. A., Al-Abcha, A., El-Am, E., Walters, R. W., Goldsweig, A. M., Alkhouli, M., Guerrero, M., & Anavekar, N. S. (2023). Racial and Ethnic Disparities in the Use and Outcomes of Transcatheter Mitral Valve Replacement: Analysis From the National Inpatient Sample Database. J Am Heart Assoc, 12(7), e028999. https://doi.org/10.1161/JAHA.122.028999

            Background Racial and ethnic disparities in outcomes exist following many cardiac procedures. Transcatheter mitral valve replacement (TMVR) has grown as an alternative to mitral valve surgery for patients at high surgical risk. The outcomes of TMVR by race and ethnicity are unknown. We aimed to evaluate racial and ethnic disparities in the outcomes of TMVR. Methods and Results We analyzed the National Inpatient Sample database from 2016 to 2020 to identify hospitalizations for TMVR. Racial and ethnic disparities in TMVR outcomes were determined using logistic regression models. Between 2016 and 2020, 5005 hospitalizations for TMVR were identified, composed of 3840 (76.7%) White race, 505 (10.1%) Black race, 315 (6.3%) Hispanic ethnicity, and 345 (6.9%) from other races (Asian, Pacific Islander, American Indian or Alaska Native, Other). Compared with other racial and ethnic groups, Black patients were significantly younger and more likely to be women (both P<0.01). There were no significant differences between White, Black, and Hispanic patients in in-hospital mortality (5.2% versus 5.0% versus <3.5%; P=0.89) and procedural complications, including heart block (P=0.91), permanent pacemaker (P=0.49), prosthetic valve dysfunction (P=0.45), stroke (P=0.37), acute kidney injury (P=0.32), major bleeding (P=0.23), and blood transfusion (P=0.92), even after adjustment for baseline characteristics. Adjusted vascular complications were higher in Black compared with White patients (P=0.03). Trend analysis revealed a significant increase in TMVR in all racial and ethnic groups from 2016 to 2020 (P(trend)<0.05). Conclusions Between 2016 and 2020, Black and Hispanic patients undergoing TMVR had similar in-hospital outcomes compared with White patients, except for higher vascular complications in Black patients. Further comparative studies of TMVR in clinically similar White patients and other racial and ethnic groups are warranted to confirm our findings.

Kahneman, D. (2011). Thinking, fast and slow. NY: Macmillan.

Kapadia, S. R., Yeh, R. W., Price, M. J., Piccini, J. P., Nair, D. G., Bansal, A., Hsu, J. C., Freeman, J. V., Christen, T., Allocco, D. J., & Gibson, D. N. (2024). Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv, 17(9), e013750. https://doi.org/10.1161/CIRCINTERVENTIONS.123.013750

            BACKGROUND: PINNACLE FLX (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the WATCHMAN FLX LAA Closure Technology) demonstrated improved outcomes and low incidence of adverse events with the WATCHMAN FLX device in a controlled setting. The National Cardiovascular Disease Registry's Left Atrial Appendage Occlusion Registry was utilized to assess the safety and effectiveness of WATCHMAN FLX in contemporary clinical practice in the United States. METHODS: The WATCHMAN FLX Device Surveillance Post Approval Analysis Plan used data from the Left Atrial Appendage Occlusion registry to identify patients undergoing WATCHMAN FLX implantation between August 2020 and September 2022. The key safety end point was defined as all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular intervention between device implantation and hospital discharge. Major adverse events were reported at hospital discharge, 45 days, and 1 year. RESULTS: Among 97 185 patients in the Left Atrial Appendage Occlusion registry undergoing WATCHMAN FLX, successful implantation occurred in 97.5% (n=94 784) of patients. The key safety end point occurred in 0.45% of patients. At 45 days post-procedure, all-cause death occurred in 0.81% patients, ischemic stroke in 0.23%, major bleeding in 3.1%, pericardial effusion requiring intervention in 0.50%, device-related thrombus in 0.44%, and device embolism in 0.04% patients. No peri-device leak was observed in 83.1% of patients at 45 days. At 1 year, the rate of all-cause death was 8.2%, the rate of any stroke was 1.5% (ischemic stroke, 1.2%), and major bleeding occurred in 6.4% of patients. CONCLUSIONS: In a large contemporary cohort of patients with the WATCHMAN FLX device, the rates of implant success and clinical outcomes through 1 year were comparable with the PINNACLE FLX study, demonstrating that favorable outcomes achieved in the pivotal approval study can be replicated in routine clinical practice.

            The primary aim of this chapter is to provide a framework to understand and synthesize the processes of person construal—early perceptions that lead to initial ingroup/outgroup categorizations—with the processes involved in intergroup relations. To this end, we review research examining the initial perception and categorization of ingroup and outgroup members and its downstream consequences. We first discuss bottom-up processes in person construal based on visual features (e.g., facial prototypicality and bodily cues), and then discuss how top-down factors (e.g., beliefs, stereotypes) may influence these processes. Next, we examine how the initial categorization of targets as ingroup or outgroup members influences identification, stereotyping, and group-based evaluations, and the relations between these constructs. We also explore the implications of the activation of these constructs for a range of social judgments including emotion identification, empathy, and intergroup behaviors. Finally, we describe a variety of well established and more recent strategies to reduce intergroup bias that target the activation of category-based knowledge, including intergroup contact, approach orientations, evaluative conditioning, and perspective taking.

Khaing, E., Aroudaky, A., Dircks, D., Almerstani, M., Alziadin, N., Frankel, S., Hollenberg, B., Limsiri, P., Schleifer, W., Easley, A., Tsai, S., Anderson, D., Windle, J., Khan, F., Haynatzki, G., Peeraphatdit, T., Goyal, N., Dunbar Matos, C. L., & Naksuk, N. (2025). Representation of Women in Atrial Fibrillation Ablation Randomized Controlled Trials: Systematic Review. J Am Heart Assoc, 14(2), e035181. https://doi.org/10.1161/JAHA.124.035181

            BACKGROUND: Sex inequality in randomized controlled trials (RCTs) related to cardiovascular disease has been observed. This study examined the proportion of women enrolled in atrial fibrillation (AF) ablation RCTs and the potential risks of underrepresentation of women. METHODS AND RESULTS: We systematically searched PubMed and Embase for AF ablation RCTs published from 2015 to 2022. Participant characteristics were compared among trials with higher and lower proportions of women. Of 147 AF ablation RCTs (30,055 participants), only 10 trials had enrolled women >/=50% of the total participants. Additionally, 42 trials (28.57%) excluded pregnant/breastfeeding women; 6 (4.1%) excluded reproductive-age women without reliable birth control. The proportion of women in AF RCTs ranged from 9% to 71% (median 31.5%), whereas the median proportion of men was 67.7%. The rate of women included in the trials was stable from 2015 to 2022 (P=0.49). Study characteristics, including funding source, showed no correlation with the rate of inclusion of women. RCTs with a higher proportion of female participants enrolled older patients with AF, had a higher prevalence of hypertension but less persistent AF, and smaller left atrium size (P<0.05 for all). Biological sex was evaluated as a risk factor or in a subgroup analysis in 28 RCTs; 10.7% of these trials observed the implication of sex on their results. CONCLUSION: Women were underrepresented in contemporary AF ablation RCTs. Additionally, women enrolled in AF RCTs were likely to have more comorbidities but less advanced AF, limiting the applicability of the results to women with AF.

Khan, M. S., Shahid, I., Siddiqi, T. J., Khan, S. U., Warraich, H. J., Greene, S. J., Butler, J., & Michos, E. D. (2020). Ten-Year Trends in Enrollment of Women and Minorities in Pivotal Trials Supporting Recent US Food and Drug Administration Approval of Novel Cardiometabolic Drugs. J Am Heart Assoc, 9(11), e015594. https://doi.org/10.1161/JAHA.119.015594

            Background In 1993, the US Food and Drug Administration established guidelines to increase diversity by sex and race/ethnicity of participants in clinical trials supporting novel drug approvals. In this study we investigated the 10-year trends of participation of women and minorities in pivotal trials supporting approval of new molecular entities in cardiometabolic drugs from January 2008 to December 2017. Methods and Results A list of new molecular entities was abstracted from publicly available data at Drugs@Fda. Sex and race/ethnicity data were collected from trial publications. Linear regression analysis was performed to assess the relation between drug approval year and proportion of women and minorities enrolled. Thirty-five novel cardiovascular (n=24) and diabetes mellitus (n=11) drugs were approved by the US Food and Drug Administration during the study period. The median number of participants supporting each drug was 5930 (interquartile range, 3175-10 942). Women represented 36% (n=108 052) of trial participants (n=296 163). Women were underrepresented compared with their proportion of the disease population in trials of coronary heart disease (participation-to-prevalence ratio, 0.52), heart failure (participation-to-prevalence ratio, 0.58), and acute coronary syndrome (participation-to-prevalence ratio, 0.68). Among trial participants, 81% were white, 4% black, 12% Asian, and 11% Hispanic/Latino. There was no significant association between enrollment of women (P=0.29) or underrepresented minorities (P=0.45) with the drug approval year. Conclusions Over the past decade (2008-2017), women and minorities, particularly blacks, have continued to be inadequately represented in pivotal cardiometabolic clinical trials that support US Food and Drug Administration approval of new molecular entities. This may have major implications in determining efficacy of such therapies in these groups, and may impair generalizability of trial results to routine clinical practice.

Knapp, P., Bower, P., Lidster, A., O’Hare, H., Sol, L. F., Golder, S., Keyworth, C., Parker, A., & Sheridan, R. (2025). Why do patients take part in research? An updated overview of systematic reviews of psychosocial barriers and facilitators. Trials, 26(1), 174. https://doi.org/10.1186/s13063-025-08850-6

Lee, H. S. (2023). Implementation of a universal prescreening protocol to improve clinical trial accrual. Journal of Oncology Practice, 19(4), e245-e252. https://doi.org/10.1200/OP.22.00452

Lieberman, M., Eisenberger, N. I., & Crockett, M. J. (2007). Putting feelings into words: Affect labeling disrupts amygdala activity in response to affective stimuli. Psychological Science, 18(5), 421-428.  https://journals.sagepub.com/doi/10.1111/j.1467-9280.2007.01916.x?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed

            Putting feelings into words (affect labeling) has long been thought to help manage negative emotional experiences; however, the mechanisms by which affect labeling produces this benefit remain largely unknown. Recent neuroimaging studies suggest a possible neurocognitive pathway for this process, but methodological limitations of previous studies have prevented strong inferences from being drawn. A functional magnetic resonance imaging study of affect labeling was conducted to remedy these limitations. The results indicated that affect labeling, relative to other forms of encoding, diminished the response of the amygdala and other limbic regions to negative emotional images. Additionally, affect labeling produced increased activity in a single brain region, right ventrolateral prefrontal cortex (RVLPFC). Finally, RVLPFC and amygdala activity during affect labeling were inversely correlated, a relationship that was mediated by activity in medial prefrontal cortex (MPFC). These results suggest that affect labeling may diminish emotional reactivity along a pathway from RVLPFC to MPFC to the amygdala.

Lolic, M., Araojo, R., Okeke, M., & Woodcock, J. (2021). Racial and Ethnic Representation in US Clinical Trials of New Drugs and Biologics, 2015-2019. JAMA, 326(21), 2201-2203. https://doi.org/10.1001/jama.2021.16680

            This study reviews the participation of racial and ethnic populations at US sites in 2015-2019 to understand the extent to which US trial participation represents the diversity of the US population.

Long, C., Williams, A. O., McGovern, A. M., Jacobsen, C. M., Hargens, L. M., Duval, S., & Jaff, M. R. (2024). Diversity in randomized clinical trials for peripheral artery disease: a systematic review. Int J Equity Health, 23(1), 29. https://doi.org/10.1186/s12939-024-02104-8

            BACKGROUND: Significant race and sex disparities exist in the prevalence, diagnosis, and outcomes of peripheral artery disease (PAD). However, clinical trials evaluating treatments for PAD often lack representative patient populations. This systematic review aims to summarize the demographic representation and enrollment strategies in clinical trials of lower-extremity endovascular interventions for PAD. METHODS: Following the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we searched multiple sources (Medline, EMBASE, Cochrane, Clinicaltrials.gov, WHO clinical trial registry) for randomized controlled trials (RCTs), RCT protocols, and peer-reviewed journal publications of RCTs conducted between January 2012 and December 2022. Descriptive analysis was used to summarize trial characteristics, publication or study protocol characteristics, and the reporting of demographic characteristics. Meta-regression was used to explore associations between demographic characteristics and certain trial characteristics. RESULTS: A total of 2,374 records were identified. Of these, 59 met the inclusion criteria, consisting of 35 trials, 14 publications, and 10 protocols. Information regarding demographic representation was frequently missing. While all 14 trial publications reported age and sex, only 4 reported race/ethnicity, and none reported socioeconomic or marital status. Additionally, only 4 publications reported clinical outcomes by demographic characteristics. Meta-regression analysis revealed that 6% more women were enrolled in non-European trials (36%) than in European trials (30%). CONCLUSIONS: The findings of this review highlight potential issues that may compromise the reliability and external validity of study findings in lower-extremity PAD RCTs when applied to the real-world population. Addressing these issues is crucial to enhance the generalizability and impact of clinical trial results in the field of PAD, ultimately leading to improved clinical outcomes for patients in underrepresented populations. REGISTRATION: The systematic review methodology was published in the International Prospective Register of Systematic Reviews (PROSPERO: CRD42022378304).

Loree, J. M., Anand, S., Dasari, A., Unger, J. M., Gothwal, A., Ellis, L. M., Varadhachary, G., Kopetz, S., Overman, M. J., & Raghav, K. (2019). Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018. JAMA Oncol, 5(10), e191870. https://doi.org/10.1001/jamaoncol.2019.1870

            IMPORTANCE: Representative racial/ethnic participation in research, especially in clinical trials that establish standards of care, is necessary to minimize disparities in outcomes and to uphold societal equity in health care. OBJECTIVE: To evaluate the frequency of race reporting and proportional race representation in trials supporting US Food and Drug Administration (FDA) oncology drug approvals. DESIGN, SETTING, AND PARTICIPANTS: Database study of all reported trials supporting FDA oncology drug approvals granted between July 2008 and June 2018. Primary reports of trials were obtained from PubMed and ClinicalTrials.gov. Food and Drug Administration approvals were identified using the FDA archives. The US population-based cancer estimates by race were calculated using National Cancer Institute-Surveillance, Epidemiology, and End Results and US Census databases. MAIN OUTCOMES AND MEASURES: Primary outcomes were the proportion of trials reporting race and the proportion of patients by race participating in trials. Secondary outcomes included race subgroup analyses reporting and gaps between race proportion in trials and the US population. Descriptive statistics, Fisher exact, and chi2 tests were used to analyze the data. Proportions and odds ratios (OR) with 95% CIs were reported. RESULTS: Among 230 trials with a total of 112 293 participants, 145 (63.0%) reported on at least 1 race, 18 (7.8%) documented the 4 major races in the United States (white, Asian, black, and Hispanic), and 58 (25.2%) reported race subgroup analyses. Reporting on white, Asian, black, and Hispanic races was included in 144 (62.6%), 110 (47.8%), 88 (38.2%), and 23 (10.0%) trials, respectively. Between July 2008 and June 2013 vs July 2013 and June 2018, the number of trials reporting race (45 [56.6%] vs 100 [67.1%]; OR, 1.63; 95% CI, 0.93-2.87; P = .09) and race subgroup analysis (13 [16.1%] vs 45 [30.2%]; OR, 2.26, 95% CI, 1.16-4.67; P = .03) changed minimally and varied across races. Whites, Asians, blacks, and Hispanics represented 76.3%, 18.3%, 3.1% and 6.1% of trial participants, respectively, and the proportion for each race enrolled over time changed nominally (blacks, 3.6% vs 2.9% and Hispanics, 5.3% vs 6.7%) from July 2008 to June 2013 vs July 2013 to June 2018. Compared with their proportion of US cancer incidence, blacks (22% of expected) and Hispanics (44% of expected) were underrepresented compared with whites (98% of expected) and Asians (438% of expected). CONCLUSIONS AND RELEVANCE: Race and race subgroup analysis reporting occurs infrequently, and black and Hispanic races are consistently underrepresented compared with their burden of cancer incidence in landmark trials that led to FDA oncology drug approvals. Enhanced minority engagement is needed in trials to ensure the validity of results and reliable benefits to all.

Martin, S. S., Aday, A. W., Almarzooq, Z. I., Anderson, C. A. M., Arora, P., Avery, C. L., Baker-Smith, C. M., Barone Gibbs, B., Beaton, A. Z., Boehme, A. K., Commodore-Mensah, Y., Currie, M. E., Elkind, M. S. V., Evenson, K. R., Generoso, G., Heard, D. G., Hiremath, S., Johansen, M. C., Kalani, R., . . . Stroke Statistics, S. (2024). 2024 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation, 149(8), e347-e913. https://doi.org/10.1161/CIR.0000000000001209

            BACKGROUND: The American Heart Association (AHA), in conjunction with the National Institutes of Health, annually reports the most up-to-date statistics related to heart disease, stroke, and cardiovascular risk factors, including core health behaviors (smoking, physical activity, nutrition, sleep, and obesity) and health factors (cholesterol, blood pressure, glucose control, and metabolic syndrome) that contribute to cardiovascular health. The AHA Heart Disease and Stroke Statistical Update presents the latest data on a range of major clinical heart and circulatory disease conditions (including stroke, brain health, complications of pregnancy, kidney disease, congenital heart disease, rhythm disorders, sudden cardiac arrest, subclinical atherosclerosis, coronary heart disease, cardiomyopathy, heart failure, valvular disease, venous thromboembolism, and peripheral artery disease) and the associated outcomes (including quality of care, procedures, and economic costs). METHODS: The AHA, through its Epidemiology and Prevention Statistics Committee, continuously monitors and evaluates sources of data on heart disease and stroke in the United States and globally to provide the most current information available in the annual Statistical Update with review of published literature through the year before writing. The 2024 AHA Statistical Update is the product of a full year's worth of effort in 2023 by dedicated volunteer clinicians and scientists, committed government professionals, and AHA staff members. The AHA strives to further understand and help heal health problems inflicted by structural racism, a public health crisis that can significantly damage physical and mental health and perpetuate disparities in access to health care, education, income, housing, and several other factors vital to healthy lives. This year's edition includes additional global data, as well as data on the monitoring and benefits of cardiovascular health in the population, with an enhanced focus on health equity across several key domains. RESULTS: Each of the chapters in the Statistical Update focuses on a different topic related to heart disease and stroke statistics. CONCLUSIONS: The Statistical Update represents a critical resource for the lay public, policymakers, media professionals, clinicians, health care administrators, researchers, health advocates, and others seeking the best available data on these factors and conditions.

Merritt, C. C., MacCormack, J. K., Stein, A. G., Lindquist, K. A., & Muscatell, K. A. (2021). The neural underpinnings of intergroup social cognition: an fMRI meta-analysis. Soc Cogn Affect Neurosci, 16(9), 903-914. https://doi.org/10.1093/scan/nsab034

            Roughly 20 years of functional magnetic resonance imaging (fMRI) studies have investigated the neural correlates underlying engagement in social cognition (e.g. empathy and emotion perception) about targets spanning various social categories (e.g. race and gender). Yet, findings from individual studies remain mixed. In the present quantitative functional neuroimaging meta-analysis, we summarized across 50 fMRI studies of social cognition to identify consistent differences in neural activation as a function of whether the target of social cognition was an in-group or out-group member. We investigated if such differences varied according to a specific social category (i.e. race) and specific social cognitive processes (i.e. empathy and emotion perception). We found that social cognition about in-group members was more reliably related to activity in brain regions associated with mentalizing (e.g. dorsomedial prefrontal cortex), whereas social cognition about out-group members was more reliably related to activity in regions associated with exogenous attention and salience (e.g. anterior insula). These findings replicated for studies specifically focused on the social category of race, and we further found intergroup differences in neural activation during empathy and emotion perception tasks. These results help shed light on the neural mechanisms underlying social cognition across group lines.

Morgan, S. E., Occa, A., Potter, J., Mouton, A., & Peter, M. E. (2017). “You Need to Be a Good Listener”: Recruiters’ Use of Relational Communication Behaviors to Enhance Clinical Trial and Research Study Accrual. Journal of Health Communication, 22(2), 95-101. https://doi.org/10.1080/10810730.2016.1256356

            Medical and research professionals who discuss clinical trials and research studies with potential participants face an often daunting challenge, particularly when recruiting from minority and underserved populations. This study reports on findings from a focus group study of 63 research coordinators, study nurses, professional recruiters, and other professionals in Indianapolis, IN and Miami, FL who work to recruit from minority and underserved populations. These professionals discussed the importance of creating a sense of connection with potential participants as part of the recruitment and retention process. Building a relationship, however fleeting, involved a number of concrete behaviors, including listening to personal information, expressing empathy, and then providing reciprocal self-disclosures; having repeated contact, usually by working in the same environment over an extended period of time; demonstrating respect through politeness and the use of honorifics; going the extra mile for participants; offering flexibility in scheduling follow-up appointments; and creating a sense of personal and community trust by being truthful. The implications of these findings for clinical trial and research study accrual are discussed.

National Council on, D. (2024). The implicit and explicit exclusion of people with disabilities in clinical trials. https://ncd.gov.

Niranjan, S. J., Martin, M. Y., Fouad, M. N., Vickers, S. M., Wenzel, J. A., Cook, E. D., Konety, B. R., & Durant, R. W. (2020). Bias and stereotyping among research and clinical professionals: Perspectives on minority recruitment for oncology clinical trials. Cancer, 126(9), 1958-1968. https://doi.org/10.1002/cncr.32755

Nishimura, A., Carey, J., Erwin, P. J., Tilburt, J. C., Murad, M. H., & McCormick, J. B. (2013). Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Med Ethics, 14(1), 28. https://doi.org/10.1186/1472-6939-14-28

            BACKGROUND: Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified. PURPOSE: To systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods. METHODS: The search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique. RESULTS: Meta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for miscellaneous.Multiple sources of variation existed between included studies: control processes, the presence of a human proctor, real vs. simulated protocol, and assessment formats. CONCLUSIONS: Enhanced consent forms and extended discussions were most effective in improving participant understanding. Interventions of all categories had no negative impact on participant satisfaction or study accrual. Identification of best practices for studies of informed consent interventions would aid future systematic comparisons.

Noubiap, J. J., Thomas, G., Nyaga, U. F., Fitzgerald, J. L., Gallagher, C., Middeldorp, M. E., & Sanders, P. (2022). Sex disparities in enrollment and reporting of outcomes by sex in contemporary clinical trials of atrial fibrillation. J Cardiovasc Electrophysiol, 33(5), 845-854. https://doi.org/10.1111/jce.15421

            BACKGROUND: Underrepresentation of females in randomized controlled trials (RCTs) limits generalizability and quality of the evidence guiding treatment of females. This study aimed to measure the sex disparities in participants' recruitment in RCTs of atrial fibrillation (AF) and determine associated factors, and to describe the frequency of outcomes reported by sex. METHODS: MEDLINE was searched to identify RCTs of AF published between January 1, 2011, and November 20, 2021, in 12 top-tier journals. We measured the enrollment of females using the enrollment disparity difference (EDD) which is the difference between the proportion of females in the trial and the proportion of females with AF in the underlying general population (obtained from the Global Burden of Disease). Random-effects meta-analyses of the EDD were performed, and multivariable meta-regression was used to explore factors associated with disparity estimates. We also determined the proportion of trials that included sex-stratified results. RESULTS: Out of 1133 records screened, 142 trials were included, reporting on a total of 133 532 participants. The random-effects summary EDD was -0.125 (95% confidence interval [CI] = -0.143 to -0.108), indicating that females were under-enrolled by 12.5 percentage points. Female enrollment was higher in trials with higher sample size (<250 vs. >750, adjusted odds ratio [aOR] 1.065, 95% CI: 1.008-1.125), higher mean participants' age (aOR: 1.006, 95% CI: 1.002-1.009), and lower in trials conducted in North America compared to Europe (aOR: 0.945, 95% CI: 0.898-0.995). Only 36 trials (25.4%) reported outcomes by sex, and of these 29 (80.6%) performed statistical testing of the sex-by-treatment interaction. CONCLUSION: Females remain substantially less represented in RCTs of AF, and sex-stratified reporting of primary outcomes is infrequent. These findings call for urgent action to improve sex equity in enrollment and sex-stratified outcomes' reporting in RCTs of AF.

Pearson, A. R., West, T. V., Dovidio, J. F., Powers, S. R., Buck, R., & Henning, R. (2008). The fragility of intergroup relations: divergent effects of delayed audiovisual feedback in intergroup and intragroup interaction. Psychol Sci, 19(12), 1272-1279. https://doi.org/10.1111/j.1467-9280.2008.02236.x

            Intergroup interactions between racial or ethnic majority and minority groups are often stressful for members of both groups; however, the dynamic processes that promote or alleviate tension in intergroup interaction remain poorly understood. Here we identify a behavioral mechanism-response delay-that can uniquely contribute to anxiety and promote disengagement from intergroup contact. Minimally acquainted White, Black, and Latino participants engaged in intergroup or intragroup dyadic conversation either in real time or with a subtle temporal disruption (1-s delay) in audiovisual feedback. Whereas intergroup dyads reported greater anxiety and less interest in contact after engaging in delayed conversation than after engaging in real-time conversation, intragroup dyads reported less anxiety in the delay condition than they did after interacting in real time. These findings have theoretical and practical implications for understanding intergroup communication and social dynamics and for promoting positive intergroup contact.

Reza, N., Gruen, J., & Bozkurt, B. (2022). Representation of women in heart failure clinical trials: Barriers to enrollment and strategies to close the gap. Am Heart J Plus, 13, 100093. https://doi.org/10.1016/j.ahjo.2022.100093

            Heart failure is a significant public health burden that differentially impacts women. Important sex- and gender-based differences in HF risk factors, presentation, and treatment exist, and the generation of high-quality evidence is critical to elucidate these differences. Despite the remarkable growth of the heart failure clinical research enterprise over the last four decades, women remain underrepresented in heart failure clinical trials relative to the population prevalence of heart failure in women. This disparity has resulted in significant knowledge gaps regarding the optimal care of women with heart failure. In this review, we summarize the existing literature regarding the participation of women in heart failure clinical trials. Additionally, we explain the evidence surrounding sex- and gender-specific barriers to enrollment in heart failure clinical trials and describe interventions that should be implemented throughout the clinical trial lifespan to achieve sex and gender parity.

Rudolph, J. E., Zhong, Y., Duggal, P., Mehta, S. H., & Lau, B. (2023). Defining representativeness of study samples in medical and population health research. BMJ Med, 2(1), e000399. https://doi.org/10.1136/bmjmed-2022-000399

            Medical and population health science researchers frequently make ambiguous statements about whether they believe their study sample or results are representative of some (implicit or explicit) target population. This article provides a comprehensive definition of representativeness, with the goal of capturing the different ways in which a study can be representative of a target population. It is proposed that a study is representative if the estimate obtained in the study sample is generalisable to the target population (owing to representative sampling, estimation of stratum specific effects, or quantitative methods to generalise or transport estimates) or the interpretation of the results is generalisable to the target population (based on fundamental scientific premises and substantive background knowledge). This definition is explored in the context of four covid-19 studies, ranging from laboratory science to descriptive epidemiology. All statements regarding representativeness should make clear the way in which the study results generalise, the target population the results are being generalised to, and the assumptions that must hold for that generalisation to be scientifically or statistically justifiable.

Scroggins, W. A., Mackie, D. M., Allen, T. J., & Sherman, J. W. (2016). Reducing Prejudice With Labels: Shared Group Memberships Attenuate Implicit Bias and Expand Implicit Group Boundaries. Pers Soc Psychol Bull, 42(2), 219-229. https://doi.org/10.1177/0146167215621048

            In three experiments, we used a novel Implicit Association Test procedure to investigate the impact of group memberships on implicit bias and implicit group boundaries. Results from Experiment 1 indicated that categorizing targets using a shared category reduced implicit bias by increasing the extent to which positivity was associated with Blacks. Results from Experiment 2 revealed that shared group membership, but not mere positivity of a group membership, was necessary to reduce implicit bias. Quadruple process model analyses indicated that changes in implicit bias caused by shared group membership are due to changes in the way that targets are evaluated, not to changes in the regulation of evaluative bias. Results from Experiment 3 showed that categorizing Black targets into shared group memberships expanded implicit group boundaries.

Singh, K., Huang, Y., & Patel, N. (2022). In U.S. drug trials: 8% Black, 6% Asian, 11% Hispanic among participants [Harvard/Industry analysis]. https://learn.hms.harvard.edu/insights/all-insights/embracing-diversity-imperative-inclusive-clinical-trials/

Skorinko, J. L. M., DiGiovanni, C., Rondina, K., Tavares, A., Spinney, J., Kobeissi, M., Lacera, L. P., Vega, D., Beatty, P., John, M. S., & Doyle, A. (2023). The effects of perspective taking primes on the social tuning of explicit and implicit views toward gender and race. Front Psychol, 14, 1014803. https://doi.org/10.3389/fpsyg.2023.1014803

            The current research aims to investigate whether perspective taking influences social tuning, or the alignment of one's self-views, explicit attitudes, and/or implicit attitudes with those of an interaction partner. In six different experiments, participants believed they would interact with a partner to complete a task. Prior to this ostensible interaction, participants were given a perspective taking mindset prime, or not, and information about their ostensible interaction partners views. Participants then completed attitude measures related to the partner's perceived views. Experiments 1a, 1b, and 2 examined whether perspective taking with an ostensible interaction partner who endorses gender traditional (or non-traditional) views align their self-views with this partner, including implicit self-views (Experiment 2). Experiments 3-5 investigated whether perspective taking leads to social tuning for egalitarian racial attitudes, including when the partner's expectations of how others will be and when the participant learns their ostensible IAT score at the beginning of the session. We predicted perspective takers would be more likely to social tune their explicit and implicit attitudes to the attitudes of their interaction partner than non-perspective takers. Across all experiments, perspective takers were more likely to social tune their self-views and explicit attitudes than non-perspective takers. However, social tuning never occurred for implicit attitudes. Thus, future research is needed to understand why perspective taking does not influence the tuning of implicit attitudes, but other motivations, like affiliative and epistemic, do.

Smith, E. R., & DeCoster, J. (2000). Dual-Process Models in Social and Cognitive Psychology: Conceptual Integration and Links to Underlying Memory Systems. Personality and Social Psychology Review, 4(2), 108-131. https://doi.org/10.1207/s15327957pspr0402_01

            Models postulating 2 distinct processing modes have been proposed in several topic areas within social and cognitive psychology. We advance a new conceptual model of the 2 processing modes. The structural basis of the new model is the idea, supported by psychological and neuropsychological evidence, that humans possess 2 memory systems. One system slowly learns general regularities, whereas the other can quickly form representations of unique or novel events. Associative retrieval or pattern completion in the slow-learning system elicited by a salient cue constitutes the effortless processing mode. The second processing mode is more conscious and effortful; it involves the intentional retrieval of explicit, symbolically represented rulesfrom either memory system and their use to guide processing. After presenting our model, we review existing dual-process models in several areas, emphasizing their similar assumptions of a quick, effortless processing mode that rests on well-learned prior associations and a second, more effortful processing mode that involves rule-based inferences and is employed only when people have both cognitive capacity and motivation. New insights and implications of the model for several topic areas are outlined.

Soomro, Q. H., McCarthy, A., Charytan, A. M., Keane, C., Varela, D., Ways, J., Ramos, G., Nicholson, J., & Charytan, D. M. (2023). Gender Disparities in Nephrology Trials: A Meta-Analysis of Enrollment Trends between 2000 and 2021. Kidney360, 4(11), 1545-1553. https://doi.org/10.34067/KID.0000000000000281

            KEY POINTS: Women are under-represented in high-impact nephrology trials. Trends remain consistent over the past 20 years and on the basis of target condition. Addressing the imbalanced enrollment of women in trials could improve disparities in care and outcomes of kidney disease. BACKGROUND: Gender disparities in the incidence and complications of kidney diseases are well described. However, analysis to elucidate gender disparities in enrollment in nephrology randomized clinical trials (RCTs) has not been performed. METHODS: We performed a systematic review and meta-analysis of high-impact nephrology RCTs published between 2000 and 2021. We included RCTs enrolling participants aged 18 years and older in the following categories: (1) CKD, (2) AKI, (3) GN, (4) maintenance dialysis, and (5) kidney transplantation. We summarized trial characteristics according to reporting and enrollment of participants, enrollment site, publication year, trial category, and intervention type. Outcomes of interest include the proportion of enrolled male and female participants overall and according to trial category. In addition, we compared enrollment trends in the United States and globally to estimates of kidney disease prevalence. RESULTS: Most qualifying trials (373/380, 98%) reported the distribution of male and female participants. Enrollment was imbalanced overall with male participants accounting for 62% (n=215,850) of the enrolled participants and female participants for just 38% (n=133,082). Male participants formed most of trial cohorts in AKI (65%), CKD (62%), dialysis (55%), and transplant trials (65%), whereas women were majority enrollees in GN trials (61%). CKD trials under-represented women in both US trials and worldwide. CONCLUSIONS: Women are under-represented in high-impact nephrology trials with the exception of GN trials. This imbalance may contribute to disparities in outcomes and gaps in the care of women with kidney disease.

Steinberg, J. R., Turner, B. E., Weeks, B. T., Magnani, C. J., Wong, B. O., Rodriguez, F., Yee, L. M., & Cullen, M. R. (2021). Analysis of Female Enrollment and Participant Sex by Burden of Disease in US Clinical Trials Between 2000 and 2020. JAMA Network Open, 4(6), e2113749. https://doi.org/10.1001/jamanetworkopen.2021.13749

Tavakoly Sany, S. B., Behzhad, F., Ferns, G., & Peyman, N. (2020). Communication skills training for physicians improves health literacy and medical outcomes among patients with hypertension: a randomized controlled trial. BMC Health Serv Res, 20(1), 60. https://doi.org/10.1186/s12913-020-4901-8

            BACKGROUND: Improving the training of physicians about communication skills and patient health literacy (HL) is a major priority that remains an open question. We aimed to examine the effectiveness of communication skills training for physicians on the hypertension outcomes and the health literacy skills, self-efficacy and medication adherence in patients with uncontrolled blood pressure (BP). METHODS: A randomized, controlled trial method was conducted on 240 hypertensive patients and 35 physicians presenting to healthcare clinics in the Mashhad, Iran, from 2013 to 2014. Using stratified blocking with block sizes of 4 and 6, eligible patients with uncontrolled blood pressure were randomly allocated to the intervention and control groups. Physicians in the intervention group received educational training over 3 sessions of Focus -Group Discussion and 2 workshops. The control group received the routine care. The primary outcome was a reduction in systolic and diastolic BP from baseline to 6 months. The secondary outcome was promoting HL skills in hypertensive patients. Data were analyzed using the regression model and bivariate tests. RESULTS: After the physician communication training, there was a significant improvement in physicians-patient communication skills, hypertension outcomes, medication adherence, and self-efficacy among the patients being managed by the physicians receiving training, compared to the control group. CONCLUSION: The educational intervention leads to better BP control; it may have been sufficient training of physicians change to impact counseling, HL and self-efficacy and adherence. The quality of physician-patient communication is an important modifiable element of medical communication that may influences health outcomes in hypertensive Iranian patients. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT), IRCT20160710028863N24. Registered April 4, 2018 [retrospectively registered].

Todd, A. R., Bodenhausen, G. V., Richeson, J. A., & Galinsky, A. D. (2011). Perspective taking combats automatic expressions of racial bias. J Pers Soc Psychol, 100(6), 1027-1042. https://doi.org/10.1037/a0022308

            Five experiments investigated the hypothesis that perspective taking--actively contemplating others' psychological experiences--attenuates automatic expressions of racial bias. Across the first 3 experiments, participants who adopted the perspective of a Black target in an initial context subsequently exhibited more positive automatic interracial evaluations, with changes in automatic evaluations mediating the effect of perspective taking on more deliberate interracial evaluations. Furthermore, unlike other bias-reduction strategies, the interracial positivity resulting from perspective taking was accompanied by increased salience of racial inequalities (Experiment 3). Perspective taking also produced stronger approach-oriented action tendencies toward Blacks (but not Whites; Experiment 4). A final experiment revealed that face-to-face interactions with perspective takers were rated more positively by Black interaction partners than were interactions with nonperspective takers--a relationship that was mediated by perspective takers' increased approach-oriented nonverbal behaviors (as rated by objective, third-party observers). These findings indicate that perspective taking can combat automatic expressions of racial biases without simultaneously decreasing sensitivity to ongoing racial disparities.

Turner, B. E., Steinberg, J. R., Weeks, B. T., Rodriguez, F., & Cullen, M. R. (2022). Race/ethnicity reporting and representation in US clinical trials: a cohort study. Lancet Reg Health Am, 11. https://doi.org/10.1016/j.lana.2022.100252

            BACKGROUND: Systemic progress in improving trial representation is uncertain, and previous analyses of minority trial participation have been limited to small cohorts with limited exploration of driving factors. METHODS: We analyzed detailed trial records from all US clinical trials registered in ClinicalTrials.gov from March 2000 to March 2020. Minority enrollment was compared to 2010 US Census demographic estimates using Wilcoxon test. We utilized logistic regression and generalized linear regression with a logit link to assess the association of possible drivers (including trials' funding source, size, phase, and design) with trials' disclosure of and amount of minority enrollment respectively. FINDINGS: Among 20,692 US-based trials with reported results (representing ~4.76 million enrollees), only 43% (8,871/20,692) reported any race/ethnicity data. The majority of enrollees were White (median 79.7%; interquartile range [IQR] 61.9-90.0%), followed by Black (10.0%; IQR 2.5-23.5%), Hispanic/Latino (6.0%; IQR 0.43-15.4%), Asian (1.0%; IQR 0.0-4.1%), and American Indian (0.0%; IQR 0.0-0.2%). Median combined enrollment of minority race/ethnicity groups (Black, Hispanic/Latino, Asian, American Indian, Other/Multi) was below census estimates (27.6%) (p<0.001) however increased at an annual rate of 1.7%. Industry and Academic funding were negatively associated with race/ethnicity reporting (Industry adjusted odds ratio [aOR]: 0.42, 95% confidence interval [CI]: 0.38 to 0.46, p<0.0001; Academic aOR: 0.45, CI: 0.41 to 0.50, p<0.0001). Industry also had a negative association with the proportion of minority ethnicity enrollees (aOR: 0.69, CI: 0.60 to 0.79) compared to US Government-funded trials. INTERPRETATION: Over the past two decades, the majority of US trials in ClinicalTrials.gov do not report race/ethnicity enrollment data, and minorities are underrepresented in trials with modest improvement over time. FUNDING: Stanford Medical Scholars Research Funding, the National Heart, Lung, and Blood Institute, NIH (1K01HL144607) and the American Heart Association/Robert Wood Johnson Medical Faculty Development Program.

West, M. T., Goodyear, S. M., Hobbs, E. A., Kaempf, A., Kartika, T., Ribkoff, J., Chun, B., & Mitri, Z. I. (2023). Real-World Evaluation of Disease Progression After CDK 4/6 Inhibitor Therapy in Patients With Hormone Receptor-Positive Metastatic Breast Cancer. Oncologist, 28(8), 682-690. https://doi.org/10.1093/oncolo/oyad035

            BACKGROUND: Cyclin-dependent kinase 4/6 inhibitors (CDKi) have changed the landscape for treatment of patients with hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER-) metastatic breast cancer (MBC). However, next-line treatment strategies after CDKi progression are not yet optimized. We report here the impact of clinical and genomic factors on post-CDKi outcomes in a single institution cohort of HR+/HER2- patients with MBC. METHODS: We retrospectively reviewed the medical records of patients with HR+/HER2- MBC that received a CDKi between April 1, 2014 and December 1, 2019 at our institution. Data were summarized using descriptive statistics, the Kaplan-Meier method, and regression models. RESULTS: We identified 140 patients with HR+/HER2- MBC that received a CDKi. Eighty percent of patients discontinued treatment due to disease progression, with a median progression-free survival (PFS) of 6.0 months (95% CI, 5.0-7.1), whereas those that discontinued CDKi for other reasons had a PFS of 11.3 months (95% CI, 4.6-19.4) (hazard ratio (HR) 2.53, 95% CI, 1.50-4.26 [P = .001]). The 6-month cumulative incidence of post-CDKi progression or death was 51% for the 112 patients who progressed on CDKi. Patients harboring PTEN mutations pre-CDKi treatment had poorer clinical outcomes compared to those with wild-type PTEN. CONCLUSION: This study highlights post-CDKi outcomes and the need for further molecular characterization and novel therapies to improve treatments for patients with HR+/HER2- MBC.

Whitelaw, S., Sullivan, K., Eliya, Y., Alruwayeh, M., Thabane, L., Yancy, C. W., Mehran, R., Mamas, M. A., & Van Spall, H. G. C. (2021). Trial characteristics associated with under-enrolment of females in randomized controlled trials of heart failure with reduced ejection fraction: a systematic review. Eur J Heart Fail, 23(1), 15-24. https://doi.org/10.1002/ejhf.2034

            AIMS: To evaluate temporal trends in the enrolment of females in randomized controlled trials (RCTs) of heart failure with reduced ejection fraction (HFrEF) published in high-impact journals, and assess RCT characteristics associated with under-enrolment. METHODS AND RESULTS: We searched MEDLINE, EMBASE and CINAHL for studies published from January 2000 to May 2019 in journals with impact factor >/=10. We included RCTs that recruited adults with HFrEF. We used a 20% threshold below the sex distribution of HFrEF to define under-enrolment. We used multivariable logistic regression to assess trial characteristics independently associated with under-enrolment. We included 317 RCTs. Among the 183 097 participants, mean (standard deviation) age was 63.0 (7.0) years and 25.5% were female. Females were under-enrolled in 71.6% [95% confidence interval (CI) 66.6-76.6%] of the RCTs; enrolment did not increase significantly between 2000-2019. Sex-related eligibility criteria [odds ratio (OR) 2.05, 95% CI 1.01-4.16; P = 0.046]; recruitment in ambulatory settings (OR 2.56, 95% CI 1.37-4.81; P = 0.003); trial coordination in North America (OR 4.44, 95% CI 1.09-18.07; P = 0.037), Europe (OR 6.79, 95% CI 1.63-27.39; P = 0.018) and Asia (OR 9.33, 95% CI 1.40-12.40; P = 0.033); drug (OR 1.76, 95% CI 1.96-7.36; P < 0.001) and device/surgical interventions (OR 1.69, 95% CI 1.16-9.43; P = 0.002); and men in first and last authorship position (OR 1.32, 95% CI 1.12-3.54; P = 0.047) were associated with under-enrolment of females. CONCLUSIONS: Females were under-enrolled relative to disease distribution in a majority of high-impact HFrEF RCTs, with no change in temporal trends between 2000 and 2019. Trial characteristics and gender of trial leaders were associated with under-enrolment.

Williams, C. P., Senft Everson, N., Shelburne, N., & Norton, W. E. (2021). Demographic and Health Behavior Factors Associated With Clinical Trial Invitation and Participation in the United States. JAMA Netw Open, 4(9), e2127792. https://doi.org/10.1001/jamanetworkopen.2021.27792

            IMPORTANCE: Representative enrollment in clinical trials is critical to ensure equitable and effective translation of research to practice, yet disparities in clinical trial enrollment persist. OBJECTIVE: To examine person-level factors associated with invitation to and participation in clinical trials. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study analyzed responses from 3689 US adults who participated in the nationally representative Health Information National Trends Survey, collected February through June 2020 via mailed questionnaires. EXPOSURES: Demographic, clinical, and health behavior-related characteristics. MAIN OUTCOMES AND MEASURES: History of invitation to and participation in a clinical trial, primary information sources, trust in information sources, and motives for participation in clinical trials were described. Respondent characteristics are presented as absolute numbers and weighted percentages. Associations between respondent demographic, clinical, and health behavior-related characteristics and clinical trial invitation and participation were estimated using survey-weighted logistic regression models. RESULTS: The median (IQR) age of the 3689 respondents was 48 (33-61) years, and most were non-Hispanic White individuals (2063 [59%]; non-Hispanic Black, 452 [10%]; Hispanic, 521 [14%]), had more than a high school degree (2656 [68%]), were employed (1809 [58%]), and had at least 1 medical condition (2535 [61%]). Overall, 439 respondents (9%) had been invited to participate in any clinical trial. Respondents with increased odds of invitation were non-Hispanic Black compared with non-Hispanic White (adjusted odds ratio [aOR], 1.85; 95% CI, 1.13-3.02), had greater than a high school education compared with less than high school education (eg, >/=college degree: aOR, 4.84; 95% CI, 1.89-12.39), were single compared with married or living as married (aOR, 1.68; 95% CI, 1.04-2.73), and had at least 1 medical condition compared to none (eg, 1 medical condition: aOR, 2.25; 95% CI, 1.32-3.82). Respondents residing in rural vs urban areas had 77% decreased odds of invitation to a clinical trial (aOR 0.33; 95% CI 0.17-0.65). Of invited respondents, 199 (47%) participated. Compared with non-Hispanic White respondents, non-Hispanic Black respondents had 72% decreased odds of clinical trial participation (aOR, 0.28; 95% CI, 0.09-0.87). Respondents most frequently reported "health care providers" as the first and most trusted source of clinical trial information (first source: 2297 [59%]; most trusted source: 2597 [70%]). The most frequently reported motives for clinical trials participation were "wanting to get better" (2294 [66%]) and the standard of care not being covered by insurance (1448 [41%]). CONCLUSIONS AND RELEVANCE: The findings of this study suggest that invitation to and participation in clinical trials may differ by person-level demographic and clinical characteristics. Strategies toward increasing trial invitation and participation rates across diverse patient populations warrant further research to ensure equitable translation of clinical benefits from research to practice..

Anaba, U., Ishola, A., Shah, C., et al. (2021). Diversity in modern heart failure trials: Where are we, and where are we going. International Journal of Cardiology, 348, 95–101. https://doi.org/10.1016/j.ijcard.2021.12.018

Abstract: Heart failure remains a leading cause of cardiovascular morbidity and mortality. Despite significant advances in medical therapy, there remain significant inequities in available clinical trials and studies aimed at the care of broad patient populations. Within this review, we examine and discuss recent landmark cardiovascular disease trials, with a specific focus on the representation of Blacks within several critically foundational heart failure clinical trials tied to contemporary treatment strategies and drug approvals. We also discuss solutions for inequities in clinical trial enrollment and representation.

Berkowitz, S. T., Groth, S. L., Gangaputra, S., & Patel, S. (2021). Racial/ethnic disparities in ophthalmology clinical trials resulting in US Food and Drug Administration drug approvals from 2000 to 2020. JAMA Ophthalmology, 139(6), 629-637. https://doi.org/10.1001/jamaophthalmol.2021.0857

Abstract: This study examined racial and ethnic representation in pivotal ophthalmology clinical trials that led to FDA drug approvals between 2000 and 2020. The analysis revealed significant underrepresentation of racial and ethnic minorities in these trials, with implications for the generalizability of trial findings to diverse populations.

Bowe, T., Salabati, M., Soares, R. R., et al. (2022). Racial, ethnic, and gender disparities in diabetic macular edema clinical trials. Ophthalmology Retina, 6(6), 531-533. https://doi.org/10.1016/j.oret.2022.01.018

Abstract: This study assessed the representation of racial, ethnic, and gender groups in diabetic macular edema clinical trials. The findings revealed significant disparities in enrollment, with underrepresentation of minority populations despite their higher disease burden.

Breathett, K., Allen, L. A., Helmkamp, L., et al. (2021). Representation of Black patients in heart failure clinical trials. Current Opinion in Cardiology, 36(3), 268–275. https://doi.org/10.1097/HCO.0000000000000849

Abstract: Black patients with heart failure in the United States are underrepresented in clinical trials relative to their overrepresentation in the heart failure population and in adverse heart failure outcomes. Multiple landmark heart failure trials published since 2019 have underrepresented Black patients, though several discussed this lack of representation as limitations. A review of large heart failure clinical trials from 2001 to 2016 found persistent underrepresentation of Black patients without significant change over time. Trials enrolling from North America exclusively had more proportional representation, enrolling an average of 31.6% Black participants. There is a shrinking proportion of Black patients in pivotal heart failure trials despite a higher prevalence of disease and associated adverse outcomes.

Buffenstein, I., Kaneakua, B., Taylor, E., Matsunaga, M., Choi, S. Y., Carrazana, E., Viereck, J., Liow, K. K., & Ghaffari-Rafi, A. (2023). Demographic recruitment bias of adults in United States randomized clinical trials by disease categories between 2008 to 2019: a systematic review and meta-analysis. Scientific Reports, 13, 42. https://doi.org/10.1038/s41598-022-23664-1

Abstract: To promote health equity within the United States (US), randomized clinical trials should strive for unbiased representation. A systematic review and meta-analysis were conducted using MEDLINE, Embase, CENTRAL, and ClinicalTrials.gov, between 01/01/2008 to 12/30/2019. 2977 trials met inclusion criteria (participants, n = 607,181). 36% of trials reported ethnicity and 53% reported race. Three trials (0.10%) included transgender participants (n = 5). Compared with 2010 US Census data, females (48.3%, 95% CI 47.2–49.3, p < 0.0001), Hispanics (11.6%, 95% CI 10.8–12.4, p < 0.0001), American Indians and Alaskan Natives (AIAN, 0.19%, 95% CI 0.15–0.23, p < 0.0001), Asians (1.27%, 95% CI 1.13–1.42, p < 0.0001), Whites (77.6%, 95% CI 76.4–78.8, p < 0.0001), and multiracial participants (0.25%, 95% CI 0.21–0.31, p < 0.0001) were under-represented, while Native Hawaiians and Pacific Islanders (0.76%, 95% CI 0.71–0.82, p < 0.0001) and Blacks (17.0%, 95% CI 15.9–18.1, p < 0.0001) were over-represented. These results demonstrate disparities in US randomized clinical trial recruitment between 2008 to 2019.

Center for Information & Study on Clinical Research Participation (CISCRP). (2023). 2023 Perceptions & Insights Study: Demographic breakdown in clinical trial respondents. Boston, MA: CISCRP. Retrieved October 13, 2025, from https://pmc.ncbi.nlm.nih.gov/articles/PMC12018620/

Abstract: This comprehensive study examines perceptions and attitudes toward clinical trial participation across different demographic groups. The findings highlight disparities in clinical trial awareness, willingness to participate, and barriers to enrollment among diverse populations. The study provides valuable insights into demographic patterns that influence clinical trial participation decisions.

Chen, H., et al. (2025). Demographic clinical trial diversity assessment methods: Use of real-world data. Contemporary Clinical Trials Communications, 44, 101432. https://doi.org/10.1016/j.conctc.2025.101432

Abstract: Clinical trial diversity is defined as a sample of individuals that accurately reflect the demographic composition of those impacted by a disease. Clinical trial diversity is crucial to advancing health equity, as it provides the ability to ensure consistent treatment across a range of individuals. Poor clinical trial representation can have significant implications for patient care, contributing to health disparities and unequal health outcomes. Disease-specific approaches to diversity assessment are recommended over census-based comparisons.

Cherubini, A., Corsonello, A., & Lattanzio, F. (2024). Current status of inclusion of older adults in clinical drug trials. Journal of the American Geriatrics Society, 72(3), 687–695. https://doi.org/10.1111/jgs.18703

Abstract: Despite representing the largest consumers of prescription medications, older adults remain significantly underrepresented in clinical drug trials. This review examines the current status of older adult inclusion in clinical trials, identifying barriers to participation and discussing regulatory initiatives aimed at improving representation. The authors emphasize the critical need for age-inclusive clinical research to ensure medication safety and efficacy for older populations.

Clark, L. T., Watkins, L., Piña, I. L., Elmer, M., Akinboboye, O., Gorham, M., … & Regnante, J. M. (2019). Increasing diversity in clinical trials: Overcoming critical barriers. Current Problems in Cardiology, 44(5), 148–172. https://doi.org/10.1016/j.cpcardiol.2018.11.002

Abstract: This comprehensive review identifies critical barriers to achieving diversity in clinical trials and proposes evidence-based solutions. The authors examine systemic, institutional, and individual-level barriers that contribute to underrepresentation of minority populations. The paper provides actionable recommendations for researchers, institutions, and policymakers to increase diversity and improve the generalizability of clinical trial findings.

Domínguez-Alonso, C., López-Gutiérrez, A., Arranz-Obispo, C., et al. (2024). Gender disparity in enrollment in hairy cell leukemia clinical trials (1983–2023). Blood Advances, 8(12), 2430–2438. https://doi.org/10.1182/bloodadvances.2023009889

Abstract: This study examined gender representation in hairy cell leukemia clinical trials over four decades. Despite women representing a significant proportion of hairy cell leukemia patients, the analysis revealed persistent underrepresentation of women in clinical trials. The findings highlight the need for gender-inclusive recruitment strategies in hematologic malignancy trials.

Epstein, N. K., et al. (2024). Women's representation in RCTs evaluating FDA-supervised medical devices: A systematic review. JAMA Internal Medicine, 184(8), 977–979. https://doi.org/10.1001/jamainternmed.2024.1350

Abstract: This systematic review assessed women's representation in randomized controlled trials supporting FDA medical device approvals. The analysis found significant underrepresentation of women in medical device trials, particularly for devices used to treat conditions that affect women disproportionately. The findings suggest a need for improved recruitment strategies and regulatory oversight to ensure adequate female representation.

Farrar, N., Elliott, D., Jepson, M., Young, B., Donovan, J. L., Conefrey, C., Realpe, A. X., Mills, N., Wade, J., Lim, E., Stein, R. C., Caskey, F. J., & Rooshenas, L. (2024). The role of healthcare professionals' communication in trial participation decisions: A qualitative investigation of recruitment consultations and patient interviews across three RCTs. Trials, 25(1), 829. https://doi.org/10.1186/s13063-024-08225-8

Abstract: This qualitative study examined how healthcare professionals' communication influences patient decisions about clinical trial participation. Through analysis of recruitment consultations and patient interviews across three randomized controlled trials, the study identified key communication factors that facilitate or hinder trial participation decisions, with implications for improving recruitment practices.

Fidler, M. M., Reulen, R. C., Winter, D. L., et al. (2023). Female participant representation in oncology clinical trials, 2000–2019. Oncologist, 28(6), 510–520. https://doi.org/10.1093/oncolo/oyad035

Abstract: This comprehensive analysis examined female representation in oncology clinical trials from 2000 to 2019. While overall female participation has increased over time, significant gaps remain in certain cancer types and phases of trials. The study provides recommendations for improving female recruitment and ensuring sex-specific analyses in oncology research.

Flores, L. E., Frontera, W. R., Andrasik, M. P., et al. (2021). Assessment of the inclusion of racial/ethnic minority, female, and older individuals in vaccine clinical trials. JAMA Network Open, 4(2), e2037640. https://doi.org/10.1001/jamanetworkopen.2020.37640

Abstract: This cross-sectional study examined demographic representation in vaccine clinical trials, focusing on racial/ethnic minorities, women, and older adults. The analysis found persistent underrepresentation of these groups across vaccine trials, with implications for vaccine safety and efficacy assessment in diverse populations. The findings emphasize the need for targeted recruitment strategies to achieve representative enrollment.

Fox-Rawlings, S. R., Gottschalk, L. B., Doamekpor, L. A., & Zuckerman, D. M. (2018). Diversity in medical device clinical trials: Do we know what works for which patients? The Milbank Quarterly, 96(3), 580–629. https://doi.org/10.1111/1468-0009.12341

Abstract: This study examined demographic diversity in medical device clinical trials that supported FDA approvals. The analysis revealed significant underrepresentation of women, racial/ethnic minorities, and older adults in device trials. The authors discuss the implications for device safety and effectiveness across diverse populations and provide recommendations for improving diversity in device research.

Gong, I. Y., Tan, N. S., Ali, S. H., Lebovic, G., Mamdani, M., Goodman, S. G., … & Yan, A. T. (2019). Temporal trends of women enrollment in major cardiovascular randomized clinical trials. Canadian Journal of Cardiology, 35(5), 653–660. https://doi.org/10.1016/j.cjca.2019.02.005

Abstract: This study examined temporal trends in women's enrollment in major cardiovascular randomized clinical trials. The analysis revealed ongoing underrepresentation of women in cardiovascular trials despite evidence of sex-specific differences in cardiovascular disease presentation and outcomes. The findings highlight the need for improved recruitment strategies to achieve gender equity in cardiovascular research.

Gray, D. M., II, Nolan, T. S., Gregory, J., & Joseph, J. J. (2021). Diversity in clinical trials: An opportunity and imperative for community engagement. Lancet Gastroenterology & Hepatology, 6(8), 605-607. https://doi.org/10.1016/S2468-1253(21)00228-4

Abstract: This commentary discusses the critical importance of diversity in clinical trials and the role of community engagement in achieving representative enrollment. The authors emphasize that lack of diversity limits the generalizability of trial findings and perpetuates health disparities.

Gupta, R., Umeh, C., Mohta, T., et al. (2024). Representation of women and racial minorities in SGLT2 inhibitors and heart failure clinical trials. International Journal of Cardiology: Heart & Vasculature, 55, 101539. https://doi.org/10.1016/j.ijcha.2024.101539

Abstract: Inadequate representation of women and racial minorities in heart failure (HF) clinical trials continues to limit the generalizability of the results. This could create a disparity in treatment for future heart failure therapies and devices. The study aims to assess the representation of women and racial minorities in recent heart failure studies involving sodium-glucose cotransporter-2 (SGLT-2) inhibitors. A total of 43 RCTs with 27,703 participants were identified. The overall proportion of women enrolled in the studies was 35.6%. Data on race was partially reported in 25 studies (58%). In the studies that reported race data, 72.91% were Caucasians, 15.48% were Asians, 5.62% were African-American and 4.1% were mixed race or others. Our study found that women and racial minority individuals have remained underrepresented in recent heart failure studies.

Jose, P. O., et al. (2021). Global representation of heart failure clinical trial leaders, collaborators, and enrolled participants: A bibliometric review 2000-2020. European Heart Journal - Quality of Care and Clinical Outcomes, 8(6), 659–668. https://doi.org/10.1093/ehjqcco/qcab056

Abstract: The geographic representation of investigators and participants in heart failure (HF) randomized clinical trials (RCTs) may not reflect the global burden of disease. We assessed the geographic diversity of RCT leaders and explored associations with geographic representation of enrolled participants among impactful HF RCTs. Regions disproportionately burdened with HF are under-represented in HF trial leadership, collaboration, and enrolment.

Khaing, E., Aroudaky, A., Dircks, D., Almerstani, M., Alziadin, N., Frankel, S., … & Naksuk, N. (2025). Representation of women in atrial fibrillation ablation randomized controlled trials: Systematic review. Journal of the American Heart Association, 14(2), e035181. https://doi.org/10.1161/JAHA.124.035181

Abstract: This systematic review examined women's representation in atrial fibrillation ablation randomized controlled trials. Despite women comprising a significant proportion of atrial fibrillation patients, the analysis found persistent underrepresentation in ablation trials. The findings have important implications for understanding sex-specific outcomes and optimizing ablation strategies for women.

Khan, M. S., Shahid, I., Siddiqi, T. J., et al. (2020). Ten-year trends in enrollment of women and minorities in pivotal trials supporting recent US Food and Drug Administration approval of novel cardiometabolic drugs. Journal of the American Heart Association, 9(11), e015594. https://doi.org/10.1161/JAHA.119.015594

Abstract: In 1993, the US Food and Drug Administration established guidelines to increase diversity by sex and race/ethnicity of participants in clinical trials supporting novel drug approvals. This study investigated 10-year trends of participation of women and minorities in pivotal trials supporting approval of new molecular entities in cardiometabolic drugs from January 2008 to December 2017. Women and minorities remain underrepresented.

Lee, H. S., et al. (2023). Implementation of a universal prescreening protocol to improve clinical trial accrual. Journal of Oncology Practice, 19(4), e245–e252. https://doi.org/10.1200/OP.22.00452

Abstract: This study evaluated the implementation of a universal prescreening protocol aimed at improving clinical trial accrual rates. The protocol successfully increased trial enrollment and improved demographic diversity among participants. The findings demonstrate the effectiveness of systematic prescreening approaches in enhancing clinical trial participation.

Lolic, M., Araojo, R., Okeke, M., & Woodcock, J. (2021). Racial and Ethnic Representation in US Clinical Trials of New Drugs and Biologics, 2015-2019. JAMA, 326(21), 2201-2203. https://doi.org/10.1001/jama.2021.16680

Abstract: This study reviews the participation of racial and ethnic populations at US sites in 2015-2019 to understand the extent to which US trial participation represents the diversity of the US population. From 517 trials, we identified 102,596 participants from US sites. The proportion of Black or African American participants ranged from 15% to 19% (mean, 16.3% vs Census, 13.4%). The proportion of Asian participants ranged from 2% to 3% (mean, 1.6% vs Census, 5.9%) and for American Indian or Alaska Native participants from 0.4% to 0.6% (mean, 0.52% vs Census, 1.3%). Hispanic or Latino participation ranged from 10% to 21% (mean, 15.3% vs Census, 18.5%). The mean and yearly participation rates were at or above the US Census level for Black or African American populations but not for other racial or ethnic minority groups.

Long, C., Williams, A. O., McGovern, A. M., Jacobsen, C. M., Hargens, L. M., Duval, S., & Jaff, M. R. (2024). Diversity in randomized clinical trials for peripheral artery disease: A systematic review. International Journal for Equity in Health, 23(1), 1–27. https://doi.org/10.1186/s12939-024-02147-4

Abstract: This systematic review examined demographic diversity in peripheral artery disease clinical trials. The analysis revealed significant underrepresentation of women, racial/ethnic minorities, and older adults despite these groups experiencing higher disease burden. The findings highlight the need for targeted recruitment strategies to achieve representative enrollment in peripheral artery disease research.

Loree, J. M., Anand, S., Dasari, A., et al. (2019). Disparity of race reporting and representation in clinical trials leading to cancer drug approvals from 2008 to 2018. JAMA Oncology, 5(10), e191870. https://doi.org/10.1001/jamaoncol.2019.1870

Abstract: Race and race subgroup analysis reporting occurs infrequently, and Black and Hispanic races are consistently underrepresented compared with their burden of cancer incidence in landmark trials that led to FDA oncology drug approvals. Enhanced minority engagement is needed in trials to ensure the validity of results and reliable benefits to all.

Loree, J. M., Anand, S., Dasari, A., Martinez, A., et al. (2023). Validating an approach for estimating appropriate Black participation in clinical trials. medRxiv. https://doi.org/10.1101/2023.07.24.23293100

Abstract: This study developed and validated an approach for estimating appropriate Black participation rates in clinical trials based on disease-specific epidemiological data. The methodology provides a framework for assessing whether Black participation in clinical trials is commensurate with disease burden, offering a more nuanced approach than simple census-based comparisons.

Martin, S. S., Aday, A. W., Almarzooq, Z. I., Anderson, C. A., Arora, P., Avery, C. L., … & American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. (2024). 2024 heart disease and stroke statistics: A report of US and global data from the American Heart Association. Circulation, 149(8), e347–e913. https://doi.org/10.1161/CIR.0000000000001224

Abstract: This comprehensive report provides updated statistics on heart disease and stroke in the United States and globally, including data on demographic disparities in cardiovascular disease burden and clinical trial participation. The report highlights persistent inequities in cardiovascular health outcomes and emphasizes the importance of inclusive research approaches.

National Council on Disability. (2024). The implicit and explicit exclusion of people with disabilities in clinical trials. Retrieved from https://ncd.gov

Abstract: This report examines the systematic exclusion of people with disabilities from clinical trials, identifying both explicit exclusion criteria and implicit barriers to participation. The analysis reveals significant underrepresentation of disabled populations in medical research and provides recommendations for creating more inclusive clinical trial practices.

Niranjan, S. J., Martin, M. Y., Fouad, M. N., Vickers, S. M., Wenzel, J. A., Cook, E. D., … & Durant, R. W. (2020). Bias and stereotyping among research and clinical professionals: Perspectives on minority recruitment for oncology clinical trials. Cancer, 126(9), 1958–1968. https://doi.org/10.1002/cncr.32761

Abstract: This study examined bias and stereotyping among research and clinical professionals regarding minority recruitment for oncology clinical trials. The findings revealed concerning patterns of implicit bias that may contribute to underrepresentation of minority populations in cancer research. The study provides insights into professional attitudes that influence recruitment practices.

Nishimura, A., Carey, J., Erwin, P. J., Tilburt, J. C., Murad, M. H., & McCormick, J. B. (2013). Improving understanding in the research informed consent process: A systematic review of 54 interventions tested in randomized control trials. BMC Medical Ethics, 14(1), 28. https://doi.org/10.1186/1472-6939-14-28

Abstract: This systematic review examined interventions designed to improve understanding in the research informed consent process. The analysis of 54 interventions tested in randomized controlled trials identified effective strategies for enhancing participant comprehension of trial information, with implications for improving informed consent practices and potentially increasing diverse participation.

Noubiap, J. J., Thomas, G., Nyaga, U. F., et al. (2022). Sex disparities in enrollment and reporting of outcomes by sex in contemporary clinical trials of atrial fibrillation. Journal of Cardiovascular Electrophysiology, 33(4), 845–854. https://doi.org/10.1111/jce.15421

Abstract: Underrepresentation of females in randomized controlled trials (RCTs) limits generalizability and quality of the evidence guiding treatment of females. This study aimed to measure the sex disparities in participants' recruitment in RCTs of atrial fibrillation (AF) and determine associated factors, and to describe the frequency of outcomes reported by sex. The random-effects summary EDD was −0.125 (95% confidence interval = −0.143 to −0.108), indicating that females were under-enrolled by 12.5 percentage points. Female enrollment was higher in trials with higher sample size, higher mean participants' age, and lower in trials conducted in North America compared to Europe. Only 36 trials (25.4%) reported outcomes by sex.

Pinnow, E., Walker, J. R., Jacobson, B. H., et al. (2014). Enrollment and monitoring of women in post-approval medical device studies. Journal of Women's Health, 23(12), 1028–1033. https://doi.org/10.1089/jwh.2014.4905

Abstract: This study examined the enrollment and monitoring of women in post-approval medical device studies. The analysis found significant underrepresentation of women in post-market device studies, limiting understanding of device performance and safety in female populations. The findings emphasize the need for improved strategies to ensure adequate female representation in device research.

Reza, N., Gruen, J., & Bozkurt, B. (2022). Representation of women in heart failure clinical trials: Barriers to enrollment and strategies to close the gap. American Heart Journal Plus: Cardiology Research and Practice, 13, 100093. https://doi.org/10.1016/j.ahjo.2022.100093

Abstract: Women are underrepresented in heart failure clinical trials despite comprising nearly half of all heart failure patients. This review examines barriers to enrollment of women in heart failure trials and proposes strategies to improve representation. Multiple factors contribute to underrepresentation including eligibility criteria, recruitment strategies, and patient-level barriers. Targeted interventions are needed to achieve equitable enrollment.

Rudolph, J. E., Zhong, Y., Duggal, P., Mehta, S. H., & Lau, B. (2023). Defining representativeness of study samples in medical and population health research. BMJ Medicine, 2, e000399. https://doi.org/10.1136/bmjmed-2022-000399

Abstract: This paper provides a comprehensive framework for defining and assessing representativeness of study samples in medical and population health research. The authors propose standardized approaches for evaluating how well study samples represent target populations, with implications for improving the generalizability of research findings.

Sarraju, A., Nissen, S. E., Yebyo, H. G., & Rodriguez, F. (2020). Under-reporting and under-representation of racial/ethnic minorities in major atrial fibrillation clinical trials. JACC: Clinical Electrophysiology, 6(6), 739–741. https://doi.org/10.1016/j.jacep.2020.02.009

Abstract: With an increasingly diverse US population, ensuring minority participation in clinical trials is important for the generalizability of AF therapies and practice guidelines across the country. We examined trials cited in the 2019 American Heart Association/American College of Cardiology/Heart Rhythm Society Focused Update guidelines. We found that 15 out of 34 trials (44%) reported participant-level racial/ethnic data. Pooled non-Hispanic white participation was 85.6%, African American participation was 2%, Hispanic participation was 5.6%, and Asian participation was 10.3%. African American and Hispanic populations were under-represented compared to US census data.

Scroggins, W. A., Mackie, D. M., Allen, T. J., & Sherman, J. W. (2016). Reducing prejudice with labels: Shared group memberships attenuate implicit bias and expand implicit group boundaries. Personality and Social Psychology Bulletin, 42(2), 219–229. https://doi.org/10.1177/0146167215621048

Abstract: This study examined how shared group membership labels can reduce prejudice and implicit bias. The findings have implications for understanding and addressing bias in clinical trial recruitment and participation, particularly regarding how group identity influences research participation decisions among minority populations.

Singh, K., Huang, Y., & Patel, N. (2022). In U.S. drug trials: 8% Black, 6% Asian, 11% Hispanic among participants [Harvard/Industry analysis]. Harvard Medical School Insights. Retrieved October 13, 2025, from https://learn.hms.harvard.edu/insights/all-insights/embracing-diversity-imperative-inclusive-clinical-trials/

Abstract: This analysis of U.S. drug trials revealed significant underrepresentation of minority populations, with Black participants comprising only 8%, Asian participants 6%, and Hispanic participants 11% of total enrollment. The findings highlight persistent disparities in clinical trial participation despite regulatory efforts to increase diversity.

Skorinko, J. L. M., DiGiovanni, C., Rondina, K., Tavares, A., Spinney, J., Kobeissi, M., … & Doyle, A. (2023). The effects of perspective-taking primes on the social tuning of explicit and implicit views toward gender and race. Frontiers in Psychology, 14, 1014803. https://doi.org/10.3389/fpsyg.2023.1014803

Abstract: This study examined how perspective-taking interventions can influence explicit and implicit attitudes toward gender and racial groups. The findings have implications for understanding and addressing bias in clinical research settings, particularly regarding how interventions might improve recruitment and participation of underrepresented groups.

Soomro, Q. H., McCarthy, A., Charytan, A. M., et al. (2023). Gender disparities in nephrology trials: A meta-analysis of enrollment trends between 2000 and 2021. Kidney360, 4(11), 1545–1553. https://doi.org/10.34067/KID.0002682023

Abstract: This meta-analysis examined gender disparities in nephrology clinical trials from 2000 to 2021. Despite women representing a significant proportion of kidney disease patients, the analysis found persistent underrepresentation of women in nephrology trials. The study provides recommendations for improving gender equity in kidney disease research.

Steinberg, J. R., Turner, B. E., Weeks, B. T., et al. (2021). Analysis of female enrollment and participant sex by burden of disease in US clinical trials between 2000 and 2020. JAMA Network Open, 4(6), e2113749. https://doi.org/10.1001/jamanetworkopen.2021.13749

Abstract: This analysis examined female enrollment in US clinical trials between 2000 and 2020 relative to disease burden. While women's participation has increased over time, significant disparities remain in certain disease areas, with underrepresentation in cardiovascular and cancer trials despite substantial disease burden.

Turner, B. E., Steinberg, J. R., Weeks, B. T., Rodriguez, F., & Cullen, M. R. (2022). Race/ethnicity reporting and representation in US clinical trials: A cohort study. Lancet Regional Health – Americas, 11, 100252. https://doi.org/10.1016/j.lana.2022.100252

Abstract: Over the past two decades, the majority of US trials in ClinicalTrials.gov do not report race/ethnicity enrollment data, and minorities are underrepresented in trials with modest improvement over time. Increased efforts are needed to improve diversity in clinical trial enrollment.

Unger, J. M., et al. (2023). Provider motivations and barriers to cancer clinical trial screening and accrual. Cancer, 129(6), 945–956. https://doi.org/10.1002/cncr.34505

Abstract: This study examined healthcare provider motivations and barriers to cancer clinical trial screening and accrual. The findings identified key factors that influence provider willingness to refer patients to trials, with implications for improving clinical trial access and potentially enhancing diversity in cancer research participation.

Van Spall, H. G. C., et al. (2022). Improving enrollment of underrepresented racial and ethnic populations in heart failure trials: A call to action from the Heart Failure Collaboratory. JACC: Heart Failure, 10(4), 215–227. https://doi.org/10.1016/j.jchf.2022.01.011

Abstract: Underrepresented racial and ethnic populations are inadequately represented in heart failure clinical trials. Underrepresentation in clinical trials limits the generalizability of the findings to these populations and may contribute to health disparities. The Heart Failure Collaboratory, a consortium of stakeholders convened by the National Institutes of Health aimed at improving trial representation, identified gaps in trial enrollment proportionate to the racial and ethnic composition of the heart failure population and provides recommendations to improve representation.

Whitelaw, S., Sullivan, K., Eliya, Y., et al. (2021). Trial characteristics associated with under-enrolment of females in randomized controlled trials of heart failure with reduced ejection fraction: a systematic review. European Journal of Heart Failure, 23(1), 15–24. https://doi.org/10.1002/ejhf.2034

Abstract: Sex-related eligibility criteria such as recruiting women who are not of childbearing age or who are on contraceptives; ambulatory recruitment; drug and device/surgery interventions; and trials with men in first and last authorship positions were each independently associated with under-enrollment of women participants. This systematic review identified specific trial characteristics that contribute to female underrepresentation in heart failure with reduced ejection fraction trials.