Enrollment Of Participants Research Articles

Evidence-based recruitment strategies for clinical research: Study personnel's and research participants' perceptions about successful methods of outreach for a U.S. Autism-Research Cohort.

Under enrollment of participants in clinical research is costly and delays study completion to impact public health. Given that research personnel make decisions about which strategies to pursue and participants are the recipients of these efforts, we surveyed research staff (n = 52) and participants (n = 4,144) affiliated with SPARK (Simons Foundation Powering Autism for Knowledge) - the largest study of autism in the U.S. - to understand their perceptions of effective recruitment strategies. In Study 1, research personnel were asked to report recruitment strategies that they tried for SPARK and to indicate which ones they would and would not repeat/recommend. In Study 2, SPARK participants were asked to indicate all the ways they heard about the study prior to enrollment and which one was most influential in their decisions to enroll. Staff rated speaking with a SPARK-study-team member (36.5%), speaking with a medical provider (19.2%), word of mouth (11.5%), and a live TV news story (11.5%) as the most successful strategies. Participants most often heard about SPARK via social media (47.0%), speaking with a medical provider (23.1%), and an online search (20.1%). Research personnel's and participants' views on effective recruitment strategies often differed, with the exception of speaking with a medical provider. Results suggest that a combination of strategies is likely to be most effective in reaching diverse audiences. Findings have implications for the selection of strategies that meet a study's specific needs, as well as recruitment-strategy "combinations" that may enhance the influence of outreach efforts.

A pilot recruitment strategy to enhance ethical and equitable access to Covid-19 pediatric vaccine trials.

The SARS-CoV-2 pandemic disproportionately impacted communities with lower access to health care in the United States, particularly before vaccines were widely available. These same communities are often underrepresented in clinical trials. Efforts to ensure equitable enrollment of participants in trials related to treatment and prevention of Covid-19 can raise concerns about exploitation if communities with lower access to health care are targeted for recruitment. To enhance equity while avoiding exploitation, our site developed and implemented a three-part recruitment strategy for pediatric Covid-19 vaccine studies. First, we publicized a registry for potentially interested participants. Next, we applied public health community and social vulnerability indices to categorize the residence of families who had signed up for the registry into three levels to reflect the relative impact of the pandemic on their community: high, medium, and low. Finally, we preferentially offered study participation to interested families living in areas categorized by these indices as having high impact of the Covid-19 pandemic on their community. This approach allowed us to meet goals for study recruitment based on public health metrics related to disease burden, which contributed to a racially diverse study population that mirrored the surrounding community demographics. While this three-part recruitment strategy improved representation of minoritized groups from areas heavily impacted by the Covid-19 pandemic, important limitations were identified that would benefit from further study. Future use of this approach to enhance equitable access to research while avoiding exploitation should test different methods to build trust and communicate with underserved communities more effectively.

Dazhu Hongjingtian Injection for Ischemic Stroke: Protocol for a Prospective, Multicenter Observational Study.

Although results from in vitro studies and small randomized controlled trials have shown positive effects of Dazhu hongjingtian injection (DZHJTI) on acute ischemic stroke (AIS), their generalizability to routine clinical practice remains to be established. The primary aim of this study is to evaluate the effectiveness of DZHJTI treatment for AIS with regard to changes in the stroke-related neurological deficit from baseline to outpatient follow-up, mortality, subsequent vascular events, disability, and traditional Chinese medicine syndrome in real-world clinical settings. By monitoring for adverse events or significant changes in vital signs and laboratory parameters, we also aim to assess the safety of DZHJTI. This prospective, multicenter cohort study plans to enroll 2000 patients with AIS within 14 days of symptom onset from 30 hospitals across China. Eligible patients will be followed up for 6 months after initiating medication treatments. The primary outcome will be the change in the National Institute of Health Stroke Scale score from baseline to outpatient follow-up. The secondary outcomes include overall mortality, stroke recurrence, new-onset major vascular events, global disability, and improvement of traditional Chinese medicine syndrome in 6 months. Adverse events or clinically significant changes in vital signs and laboratory parameters, regardless of the severity, will be recorded during the trial to assess the safety of DZHJTI. An augmented inverse propensity weighted estimator will be used to reduce variability and improve accuracy in average treatment effects estimation. The clinical trial registration was approved in October 2022, and the recruitment and enrollment of participants started in November 2022. The study's outcomes are expected to be published in 2025 in reputable, peer-reviewed health-related research journals. This real-world cohort study is the first to assess the effectiveness and safety of DZHJTI in treating AIS. It may provide additional clinical evidence, including the duration of response, long-term drug effectiveness, and subgroup efficacy data. The study results will be valuable for clinicians and patients seeking optimal treatment for AIS and could lead to better use of DZHJTI and improved patient outcomes. ITMCTR ITMCTR2022000005; http://tinyurl.com/554ns8m5. DERR1-10.2196/52447.

Longitudinal Natural History Study of Children and Adults with Rare Solid Tumors: Initial Results for First 200 Participants.

This study demonstrates that comprehensive, tumor-agnostic data and biospecimen collection is feasible to characterize different rare tumors, and speed progress in research. The findings will be foundational to developing external controls groups for single-arm interventional trials, where randomized control trials cannot be conducted because of small patient populations.

An absence of translated consent forms limits oncologic clinical trial enrollment for limited English proficiency participants

ObjectivesA lack of diversity amongst participants in cancer clinical trials has raised scrutiny over the past decade. Patients with limited English proficiency (LEP) are further excluded. One modifiable reason for low LEP participation is a lack of non-English consent forms. MethodsWe queried the clinical trials registry database at an academic hospital serving a predominantly Spanish-speaking patient population. Clinical trials related to gynecology oncology were evaluated for the availability of fully translated Spanish consent forms, the racial and ethnic identification of enrolled patients, and the number of signed Spanish consents. Enrolment data was compared before and after 2019, when institutional financial support for document translation was withdrawn. ResultsSixteen gynecologic oncology clinical trials were opened between 2014 and 2022, with 10 trials enrolling 128 patients. Eight trials opened prior to 2019, all with fully translated consent forms. Seven of these trials enrolled 99 participants, 70% of whom identified as Hispanic and 60% who signed a Spanish consent. Eight trials opened after 2019 and one had a fully translated consent form. Three of the trials enrolled 29 participants, with 10% of subjects identifying as Hispanic and none signing a Spanish consent form. ConclusionsThere was a decrease in fully translated clinical trial consent forms for gynecologic oncology studies following the loss of subsidized translation services in our single institution with a predominantly LEP population. This correlated with a decrease in enrollment of Hispanic subjects. To increase enrollment of diverse participants, including those with LEP, simple actions such as fully translating consent forms would help maintain equity in research conduct and improve clinical outcomes through trial involvement.

Predicting cognitive decline in short‐term as a viable method to improve recruitment in clinical trials of Alzheimer’s Disease

AbstractBackgroundSuccess of Alzheimer’s disease (AD) trials is partially dependent on enrollment of participants who show cognitive decline (CD) during treatment with placebo. We investigated whether trials could be enriched for CD using machine‐learning based predictive models.MethodWe used data from the placebo arm of trial of Solanezumab for mild dementia due to AD (EXPEDITION‐3 trial; N = 894) as well as individuals at the same stage of disease from Alzheimer’s Disease Neuroimaging Initiative (ADNI; N = 86). Participants were classified as showing CD vs stable cognition (SC) based on their scores on the cognitive sub‐scale of the Alzheimer’s Disease Assessment Scale (ADAS‐Cog11; Range 0‐70). The CD group included individuals who showed a minimal clinically important difference (MCID of 3 or more points increase in their ADAS‐Cog11 scores from baseline to week 80) while the SC group had a change of less than 3 points. Participants were classified into CD and SC groups using different baseline feature‐sets including volumetric MRI and neuropsychological tests (Table 2). Models were trained using 70% of the EXPEDITION‐3 data and were validated using the remaining 30%. Models trained in EXPEDITION‐3 were then externally validated using the ADNI sample.ResultOnly 56% of EXPEDITION‐3 participants treated with placebo showed MCID at 80 weeks (Table 1). Performance of the different models is summarized in Table 2. Model 4 using the random forest algorithm, which included all features and data from 6‐month follow‐up, had the best overall performance in the internal validation sample (AUC: 0.75±0.03). Models 3 and 4 performed similarly when validated in the independent ADNI sample (AUCs: 0.70±0.05, 0.66±0.06, respectively). Both Models had positive predictive values approximately 15% higher than the base prevalence of cognitive decline in the ADNI subset (∼62%). The negative predictive value of Model 3 was 23% higher than the base prevalence of stable cognition in the participants, slightly higher than that of Model 4.ConclusionEnrichment of trials through predictive models may increase the chance of success. Using 6‐month follow‐up data improves accuracy of decliner identification and may provide a basis for early exclusion of a subset unlikely to discriminate active treatment from placebo.

Abstract A085: A comparison of the recruitment and enrollment of racially and ethnically minoritized patients in two non-interventional genetic testing studies in Florida

Abstract Objectives: To compare participation rates of minority individuals in two non-interventional genetic studies. Background: Enrollment of participants into non-interventional studies is important in understanding cancer development in minority patients. Black, Hispanic, and Latin men and women are diagnosed with aggressive forms of cancer at more advanced stages however, the underlying mechanisms leading to poor outcomes of disease is still not well understood. To understand disease development, two studies were launched. Study 1 focused on the recruitment of mutation carriers not yet diagnosed with cancer. Participants of this study were of any race and consented to the collection of fresh tissue. Participants were physician-referred and approached by the study team on the day of surgery. The patients received an explanation of the objectives and conditions of participation. Study 2 was focused on recruiting minority participants in clinic with a confirmed diagnosis of breast or prostate cancer. Participants consented to the collection of archival tissue and participants were called prior to their clinic visit and explained the objectives and conditions of participation. We compared the rates of enrollment of minority patients into these non-interventional genetic studies. Methods: Participants were Black, Hispanic/Latino(a), or White, Non-Hispanic who were mutation carriers without cancer or had an active diagnosis of ovarian, breast, or prostate cancer. The study team was composed of Latin, South, and Central American Spanish-speakers and African American Caribbeans Haitian-Creole speakers. All study materials were available in English, Haitian Creole, and Spanish. Matched recruitment was completed between the patient population and study team members who spoke English, Haitian Creole, and Spanish. The studies were assessed and compared for their methods of recruitment, participation rates, and demographics of their enrolled patient populations between December 2022 and May 2023. Results: A total of 121 men and women are included in this data analysis. 81.8% of patients approached for both studies consented to participate. 92.9% of those who consented were minorities. In Study 1, 68.6% eligible patients agreed to participate (24/35). Of the 24 patients enrolled, 41.7% (10/24) were White Hispanic/Latina, 20.8% (5/24) were Black Hispanic and non-Hispanic, 29.2% (7/24) were White non-Hispanic, and 2.7% (2/36) declined race. Of those who rejected participation, 63.6% were Black non-Hispanic. In Study 2, 87.2% (75/86) of the 86 eligible patients consented to the study. 72% (54/75) were female and 28% (21/75) were male. Of the female participants, 31.5% (17/54) were Black non-Hispanic and 68.5% (37/54) were White Hispanic/Latino. Of the male participants, 47.6% (10/21) were Black and 52.3% (11/21) were Hispanic/Latino. 63.6% of those who rejected participation were White Hispanic. Conclusions: Our results indicate that study acceptance by racially and ethnically minoritized individuals is dependent on recruitment approach and current health status. Citation Format: Destiny B. Burnett, Sandy St-Hilaire, Melissa N. Castillo, Daniela M. Zuniga Carlier, Osmaray Morales Casanova, Ashlee J. Sealy, Alex P. Sanchez, Matthew P. Schulmbrecht, Camille Ragin, Sophia George, Judith Hurley, Janaki Sharma, Alejandra Perez. A comparison of the recruitment and enrollment of racially and ethnically minoritized patients in two non-interventional genetic testing studies in Florida [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A085.

Feasibility and Efficacy of the LEAD Dementia Advance Care Planning Intervention

AbstractBackgroundUsing our dementia‐focused advance care planning tool (ACP), known as the LEAD Guide (Life‐Planning in Early Alzheimer’s and Other Dementias),1‐3 we implemented a 9‐month NIH Stage‐14 behavioral intervention to promote ACP concordance in community‐based ADRD dyads. Dyads consisted of care recipients (persons concerned about dementia or those with a diagnosis of preclinical or early‐stage dementia) and their care partner. The goal of this study was to assess the feasibility and initial efficacy of the intervention.MethodFeasibility was assessed by examining the percent of enrollment of eligible participants, retention rate, and completion of data collection across study timepoints through the post intervention assessment. To explore the initial efficacy of the LEAD Intervention on study outcomes (ACP completion and dissemination, relationship quality, decision‐making self‐efficacy), we utilized longitudinal survey‐based measures to assess dyadic constructs that illustrate how the dyad functioned over time. Baseline to post changes were examined utilizing mixed effects models.ResultsWe screened 73 dyads, 58 dyads were eligible and 51 dyads participated in the study (see Figure 1 and Table 1). There were 34 dyads (67.7% retention) that completed baseline through the post‐intervention assessments. Table 2 shows results of changes in self‐report measures between baseline and post. Scores on the Decision‐Making Self‐Efficacy Scale5 revealed improved efficacy in both the care recipient and care partner at post intervention compared to baseline. Analysis showed no significant improvement in the positive domain of the Dyadic Relationship Scale6 in either care recipient or care partner, however, relationship strain domain significantly declined following the intervention in both the care recipient and care partner. Of the 51 starting dyads, 27 care recipients had already completed an advanced directive. By post, an addition 7 had completed an advanced directive, 9 were planning on completing, and 33 had shared ACP documents with others.ConclusionThe web‐based, self‐administered LEAD Intervention is a feasible and effective platform to promote ACP planning in community‐based ADRD dyads. Participation in ACP conversations and documentation can help reduce relationship strain and improve decision‐making self‐efficacy, thus promoting future care decisions that align with the care recipient’s values and preferences.

Abstract A084: Enrollment rates among multiple recruitment strategies for ULACNet-101, a clinical-trial aimed at preventing HPV-related cancers for people living with HIV in Puerto Rico

Abstract OBJECTIVES: Persons living with HIV (PLWH) have a higher risk of HPV-associated cancers than people without HIV; countries in Latin America and the Caribbean have an excess risk of these malignancies. The California-Mexico-Puerto Rico (CAMPO) Consortium conducts clinical trials (CTs) to prevent HPV-related cancers among PLWH in Mexico and Puerto Rico (PR). We are currently recruiting participants for ULACNet-101, a CTs under CAMPO. CTs depend primarily on the successful recruitment and retention of study participants to provide valid and reliable outcomes. We aimed to evaluate the enrollment rates of the different recruitment strategies implemented for the enrollment of PLWH (n=1,400) in ULACNet-101 in PR. METHODS: We analyzed data from the pre-screening database containing demographic and clinical characteristics, and the mode of study recruitment of interested participants in ULACNet-101 in PR. Given the ambitious sample size proposed in PR and delays in patient recruitment that have resulted from the COVID-19 pandemic, several approaches are being used for recruitment in PR, including passive (n=4) and active (n=4) strategies. Passive strategies involve (1) advertisements through printed flyers/banners, (2) TV/newspaper advertising, (3) social media promotion, and (4) word of mouth by friends/family/previous study participants. Active strategies include (1) on-site clinic promotion by research assistants, (2) outreach calls to participants of previous studies, (3) outreach activities, and (4) provider referrals. Descriptive statistics were used. RESULTS: From November 16, 2021 to June 1, 2023, 888 potential participants have been pre-screened (65% male and 35% female; mean age 51 ± 13 years), and 721 were determined to be eligible for enrollment (81.2%; 27% female and 73% male). 294 (40.8%) of eligible participants have been enrolled. Preliminary analysis shows that more potential participants pre-screened were referred due to active strategies (76.8%) versus passive strategies (23.2%). On-site promotion by research assistants has led to referrals for almost half (44.9%) of all pre-screenings. However, the highest enrollment rate among eligible participants has been for outreach calls to participants from previous studies (65.2%), word of mouth (59.0%) and social media (53.6%). CONCLUSIONS: As of today, the best recruitment strategy for ULACNet-101 in the PR site has been on-site clinic promotion by research assistants, followed by provider referrals. However, these strategies have not been the most effective at the subsequent enrollment of participants into the study. Continued monitoring of recruitment strategies will be essential to determine the best allocation of available resources and achieve recruitment goals. Moreover, this information will be used to guide the implementation of other cancer-related CTs for PLWH in PR. FUNDING: This project was funded by NCI (Grants # U54CA242646 and 3U54CA242646-04S2), and supported by NIGMS (# U54GM133807), NIMHD (# 2U54MD007587), PR-CEAL (# 10T2HL161827), and PR Outreach Program (# U54CA096297). Citation Format: Marievelisse Soto-Salgado, Mariela Bournigal-Feliciano, Sandra García-Camacho, Michael A. Santiago-Marrero, Frances Aponte-Caraballo, Joel Palefsky, Jorge Salmeron, Ana Patricia Ortiz. Enrollment rates among multiple recruitment strategies for ULACNet-101, a clinical-trial aimed at preventing HPV-related cancers for people living with HIV in Puerto Rico [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A084.

Hispanic/Latino perspectives about participation in online recruitment registries for research

AbstractBackgroundOnline recruitment registries have emerged as a novel approach for accelerating enrollment of participants in Alzheimer’s disease (AD) research. While investigators may benefit from having access to a large research‐ready and often prescreened population, older Hispanic/Latino adults enroll less frequently in online recruitment registries, particularly for AD. Using qualitative data from focus groups, we elicited perspectives from community dwelling older Hispanics/Latinos about barriers and facilitators to participation in online registries that recruit to AD research studies.MethodWe conducted 4 focus groups via Zoom in May 2022 and enrolled a total of 15 older Hispanic/Latino adults aged 50+ years who participated in the University of California, Irvine Consent‐to‐Contact (C2C) registry. The C2C is a local online recruitment registry that enrolls individuals from Orange County (OC), California and collects minimal data for the purpose of better matching participants to recruiting studies. We used a semi‐structured interview guide to assess Hispanic participants’ perceptions and experiences about AD research, motivators and barriers to enrolling into an online recruitment registry and suggestions for framing messages to improve enrollment.ResultHispanic/Latino participants were predominately female (60%), US born (80%), college educated (80%) and had a mean age of 60. Reflexive thematic analysis identified 3 emergent themes: (1) being personally affected by AD as a driving factor in participants’ desire to participate; (2) a lack of digital literacy and access to digital devices as a barrier to enrollment; and (3) framing messages that are culturally tailored and aimed at reducing fear towards research.ConclusionUnderstanding the factors that drive decisions to enroll in online registries among Hispanics/Latinos will be crucial for the development of interventions to improve participation. Our preliminary results highlight key concerns among older Hispanics/ Latinos already in registries. Additional focus groups will include other key stakeolders from Hispanic/Latino communities in OC to compare findings.

Gender Disparities in Nephrology Trials: A Meta-Analysis of Enrollment Trends between 2000 and 2021.

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. We performed a systematic review and meta-analysis of high impact nephrology RCTs published between 2000-2021. We. included RCTs enrolling participants age ≥18 in the following categories: 1) chronic kidney disease (CKD); 2) acute kidney injury (AKI); 3) glomerulonephritis (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. Additionally, we compared enrollment trends in the United States and globally to estimates of kidney disease prevalence. The majority of 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 the majority of trial cohorts in AKI (65%), CKD (62%), Dialysis (55%) and transplant trials (65%), whereas women were majority enrollees in glomerulonephritis trials (61%). CKD trials under-represented women in both US trials and worldwide. 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.

Evaluation of factors associated with recruitment rates in early phase clinical trials based on the European Clinical Trials Register data.

Effective participant recruitment is a critical challenge in clinical trials. Inadequate enrollment of participants can precipitate delays, escalated costs, and compromise scientific integrity. Despite its relevance, particularly during the early phases, it persists as an obstacle in the field of clinical research. The primary aim of this study was to analyze the recruitment rates of early-phase clinical trials and evaluate their potential associations with key trial characteristics. Using a descriptive and statistical analysis, a research study was conducted based on the early-phase trials registered at the European Clinical Trials Register (EU-CTR), spanning the timeframe from January 2017 to December 2021. Among the 194 trials examined, we found median recruitment rates of 68%. A more detailed exploration revealed a greater level of success in terms of recruitment achievement in pediatric trials when compared to trials involving adults, non-oncologic trials, or those also developed in non-European countries. It is important to underscore that only 69 trials out of the total managed to conclude recruitment, with the most prevalent reason for premature cessation being the presence of efficacy and safety issues or sponsor's strategy. This number can be greatly improved. Despite certain disparities observed in the information within EU-CTR, we have successfully determined the recruitment rates of the studies and established associations with some of the clinical trial characteristics analyzed. Owing to the inherent constraints of this study, further research is warranted to gain a comprehensive understanding of the intricate interplay between trial characteristics and their impact on recruitment rates in early-phase studies.

Pilot Testing of an mHealth App for Tobacco Cessation in People Living With HIV: Protocol for a Pilot Randomized Controlled Trial.

An estimated 40% of people living with HIV smoke cigarettes. Although smoking rates in the United States have been declining in recent years, people living with HIV continue to smoke cigarettes at twice the rate of the general population. Mobile health (mHealth) technology is an effective tool for people living with a chronic illness, such as HIV, as currently 84% of households in the United States report that they have a smartphone. Although many studies have used mHealth interventions for smoking cessation, few studies have recruited people living with HIV who smoke. The objective of the pilot randomized controlled trial (RCT) is to examine the feasibility, acceptability, and preliminary efficacy of the Sense2Quit App as a tool for people living with HIV who are motivated to quit smoking. The Sense2Quit study is a 2-arm RCT for people living with HIV who smoke cigarettes (n=60). Participants are randomized to either the active intervention condition, which consists of an 8-week supply of nicotine replacement therapy, standard smoking cessation counseling, and access to the Sense2Quit mobile app and smartwatch, or the control condition, which consists of standard smoking cessation counseling and a referral to the New York State Smokers' Quitline. The Sense2Quit app is a mobile app connected through Bluetooth to a smartwatch that tracks smoking gestures and distinguishes them from other everyday hand movements. In the Sense2Quit app, participants can view their smoking trends, which are recorded through their use of the smartwatch, including how often or how much they smoke and the amount of money that they are spending on cigarettes, watch videos with quitting tips, information, and distractions, play games, set reminders, and communicate with a study team member. Enrollment of study participants began in March 2023 and is expected to end in October 2023. All data collection is expected to be completed by the end of January 2024. This RCT will test the difference in outcomes between the control and intervention arms. The primary outcome will be the percentage of participants with biochemically verified 7-day point prevalence smoking or tobacco abstinence at their 12-week follow-up. Results from this pilot study will be disseminated to the research community following the completion of all data collection. The Sense2Quit study leverages mHealth so that it can help smokers improve their efforts at smoking cessation. Our research has the potential to not only increase quitting rates among people living with HIV who may need a prolonged, tailored intervention but also inform further development of mHealth for people living with HIV. This mHealth study will contribute significant findings to the greater mHealth research community, providing evidence as to how mHealth should be developed and tested among the target population. ClinicalTrials.gov NCT05609032; https://clinicaltrials.gov/study/NCT05609032. DERR1-10.2196/49558.

Good death for people living with dementia: a qualitative study

BackgroundEnsuring a good death is one of the primary objectives of palliative care and end-of-life care. There is insufficient evidence regarding what defines a good death for people living with dementia. Obtaining an understanding of what constitutes a good death could help improve dementia care. This study aimed to explore how multiple stakeholders perceive a good death for people living with dementia.MethodsThis qualitative study was carried out across six prefectures in Japan. Enrollment of participants took place within dementia outpatient clinics, hospitals, daycare centers, and community centers. A total of thirty-three in-depth interviews with people living with dementia, physicians, and nurses were conducted. Six focus group discussions were performed with family caregivers and care workers. Verbatim transcripts of the interviews were prepared, and inductive content analysis was used to examine the data.FindingsRegarding the perception of a good death, the following themes were derived: (1) painless death; (2) dying in a preferred environment; (3) family’s coping with loss; (4) maintaining regular life; (5) living with respect; and (6) preparation for death. All these themes are interrelated. Participants viewed a good death as a process rather than a single event.ConclusionThis study identifies crucial components of a good death for people living with dementia. The findings could be used to improve dementia care.

Perception and Risk Factors Associated with Tuberculosis in the Manyara Region, Tanzania

Tuberculosis (TB) results from infection with members of the Mycobacterium tuberculosis complex (MTBC) and represents a major global public health concern. We here sought to assess the perceptions of human and animal TB and the prevalence of circulating MTBCs lineages and associated risk factors through a cross-sectional survey of 335 individuals presenting with symptoms of pulmonary or extrapulmonary TB in the Manyara region of Tanzania. After the enrollment of participants, a questionnaire survey was conducted, samples were collected for bacterial culture, and real-time multiplex PCR was performed to differentiate amongst primary animal and human MTBC lineages. The results show poor TB awareness: 31.6% of the participants were not aware of human TB; 82.4% were unaware of animal TB and 95.2% lacked awareness of zoonotic TB (zTB) transmission. A total of 18 recovered specimens (5%; 95% CI: 3–8%) were positive by culture, all of which were typed as M. tuberculosis sensu stricto using a lineage-specific PCR assay. While no single risk factor was significantly associated with MTBC culture positivity, the survey revealed considerable self-reported high-risk practices for contracting zTB. Together, the results show that Manyara residents have poor knowledge of diseases caused by MTBCs and high evidence of risky practices for contracting zTB.

Optimizing a Technology-Based Body and Mind Intervention to Prevent Falls and Reduce Health Disparities in Low-Income Populations: Protocol for a Clustered Randomized Controlled Trial.

The lack of health care coverage, low education, low motivation, and inconvenience remain barriers to participating in fall prevention programs, especially among low-income older adults. Low-income status also contributes to negative aging self-perceptions and is associated with a high perceived barrier to care. Existing fall prevention intervention technologies do not enable participants and practitioners to interact and collaborate, even with technologies that bring viable strategies to maintain independence, prevent disability, and increase access to quality care. Research is also limited on the use of technology to enhance motivation and help individuals align their perception with physiological fall risk. We developed a novel, 8-week Physio-Feedback Exercise Program (PEER), which includes (1) technology-based physio-feedback using a real-time portable innovative technology-the BTrackS Balance Tracking System, which is reliable and affordable, allows for home testing, and provides feedback and tracks balance progression; (2) cognitive reframing using the fall risk appraisal matrix; and (3) peer-led exercises focusing on balance, strength training, and incorporating exercises into daily activities. This study consists of 3 aims. Aim 1 is to examine the effects of the technology-based PEER intervention on fall risk, dynamic balance, and accelerometer-based physical activity (PA). Aim 2 is to examine the effects of the PEER intervention on fall risk appraisal shifting and negative self-perceptions of aging. Aim 3 is to explore participants' experiences with the PEER intervention and potential barriers to accessing and adopting the technology-based PEER intervention to inform future research. This is an intention-to-treat, single-blinded, parallel, 2-arm clustered randomized controlled trial study. We will collect data from 340 low-income older adults at baseline (T1) and measure outcomes after program completion (T2) and follow-up at 3 months (T3) and 6 months (T4). Participants will be enrolled if they meet all the following inclusion criteria: aged ≥60 years, cognitively intact, and able to stand without assistance. Exclusion criteria were as follows: a medical condition precluding exercise or PA, currently receiving treatment from a rehabilitation facility, plan to move within 1 year, hospitalized >3 times in the past 12 months, and does not speak English or Spanish. As of August 2023, the enrollment of participants is ongoing. This study addresses the public health problem by optimizing a customized, technology-driven approach that can operate in low-resource environments with unlimited users to prevent falls and reduce health disparities in low-income older adults. The PEER is a novel intervention that combines concepts of physio-feedback, cognitive reframing, and peer-led exercise by motivating a shift in self-estimation of fall risk to align with physiological fall risk to improve balance, PA, and negative aging self-perception. ClinicalTrials.gov NCT05778604; https://www.clinicaltrials.gov/ct2/show/study/NCT05778604. DERR1-10.2196/51899.

Increasing Accrual of Racial and Ethnic Minorities in Breast Cancer Clinical Trials by Partnering with Community Hospitals

Clinical trials provide the highest level of evidence in evaluating the safety and efficacy of new radiation approaches for breast cancer. However, there is a significant lack of racial and ethnic diversity among participants who are enrolled. This discrepancy in research inclusion leads to limitations in applying clinical data, therapeutic indices, technique safety, and toxicity to a diverse patient population. A community-based approach, such as the inclusion of community hospitals in trial enrollment, has been shown to boost participation within these underserved populations. The aim of this study was to evaluate the rate of enrollment of racial and ethnic minorities in breast cancer clinical trials with the inclusion of community hospitals within an NYC hospital system. Trial enrollment of breast cancer patients at 3 hospitals was retrospectively assessed. Patient demographics, including age, race, and ethnicity, were compared by enrollment setting. Eligible trials included prospective, randomized clinical trials assessing breast cancer irradiation. Participating hospitals included an academic hospital in Manhattan (MH), and 2 community hospitals in Brooklyn (BH) and Queens (QH). Collectively, these hospitals have a catchment area of 6.2 million, of which 35.2% are White, 19.7% are Asian, 18.3% are Black/African American (B/AA), and 21.2% are Hispanic/Latino (H/L). There is a wide demographic variety within this catchment area. BH serves neighborhoods with a B/AA population as high as 85% and QH serves neighborhoods with an Asian population as high as 54%. From January to December 2022, 146 patients were enrolled in 4 breast cancer trials opened at MH (59.6%, n = 87), BH (28.8%, n = 42), and QH (11.6%, n = 17). The average age was 63.3 (SD = 12.1). Of all patients enrolled, 52.7% identified as White, 23.2% as B/AA, 13% as Asian, and 8.9% as H/L. Of the patients enrolled at MH, 64.4% identified as White, 12.6% as B/AA, 8% as Asian, and 8% as H/L. At BH, 50% identified as B/AA, 38% as White, 4.7% as Asian, and 11.9% as H/L. At QH, 58.8% identified as Asian, 29.4% as White, and 11.8% as B/AA. B/AA (OR = 4.41, 95% CI, 1.94-10.03; p<.01) and Asian (OR = 2.92, 95% CI, 1.07-7.93; p<.05) patients were more likely to be enrolled at a community hospital when compared to an academic hospital. There was no difference in enrollment rates between campuses for H/L patients (OR = 1.29, 95% CI, 0.41-4.06; p = .66). Enrollment of participants from underrepresented racial and ethnic populations in clinical trials is critical to ensuring health equity. These findings suggest partnerships with community hospitals located in underserved populations can be a strategy to improve diversity among clinical trial participants. As it is well-documented that community hospitals can deliver high quality research with similar trial metrics to larger, academic hospitals, partnerships with community hospitals are a feasible way to reduce disparities in breast cancer research.

Door-To-Door Video-Enhanced Prevalence Study of Tourette Disorder Among African Americans

ABSTRACT Tourette syndrome (TS) affects about 0.5% of the population worldwide, but only sparse and conflicting data exist on TS prevalence among minority samples. Here we used VISITTS (a survey preceded by a short video showing tic phenomenology) and community outreach to provide estimates of tic disorder prevalence in African Americans. Community health workers (CHWs) left flyers at households in a predominantly minority neighborhood and approached people at a community health fair. Of 606 such contacts, 222 individuals agreed to discuss the study. Of these, 70% enrolled, of whom 82% identified as Black and 64% female. The VISITTS was well received. Lifetime prevalence of TS or another chronic tic disorder (TS/CTD) was 3.2%, and 31% endorsed any lifetime simple tic. The number of enrolled Black participants is remarkable compared to earlier TS studies, allowing one of the first prevalence estimates in this population (TS 2.3%, TS/CTD 3.9%). Tic disorders were endorsed only by Black respondents, though the small White sample precluded statistical comparison. Women had higher rates than men of TS (M:F = 0:1) and of any lifetime simple tic (M:F = 0.85), differing significantly from the expected 4:1 ratio (p = .009 and p < .001, respectively). For TS/CTD the ratio was 1.2:1 (p > .15). We conclude that VISITTS is a feasible tic screening tool in a minority population, that CHW community outreach increases enrollment of Black participants, that TS/CTD is no less common in this population, and that tics were as common in female as in male respondents.

Enhancing Enrollment in Acute Stroke Trials: Current State and Consensus Recommendations.

The Stroke Treatment Academic Industry Roundtable (STAIR) convened a session and workshop regarding enrollment in acute stroke trials during the STAIR XII meeting on March 22, 2023. This forum brought together stroke physicians and researchers, members of the National Institute of Neurological Disorders and Stroke, industry representatives, and members of the US Food and Drug Administration to discuss the current status and opportunities for improving enrollment in acute stroke trials. The workshop identified the most relevant issues impacting enrollment in acute stroke trials and addressed potential action items for each. Focus areas included emergency consent in the United States and other countries; careful consideration of eligibility criteria to maximize enrollment and representativeness; investigator, study coordinator, and pharmacist availability outside of business hours; trial enthusiasm/equipoise; site start-up including contractual issues; site champions; incorporation of study procedures into standard workflow as much as possible; centralized enrollment at remote sites by study teams using telemedicine; global trials; and coenrollment in trials when feasible. In conclusion, enrollment of participants is the lifeblood of acute stroke trials and is the rate-limiting step for testing an exciting array of new approaches to improve patient outcomes. In particular, efforts should be undertaken to broaden the medical community's understanding and implementation of emergency consent procedures and to adopt designs and processes that are easily incorporated into standard workflow and that improve trials' efficiencies and execution. Research and actions to improve enrollment in ongoing and future trials will improve stroke outcomes more broadly than any single therapy under consideration.

Abstract 113: Aldosterone Synthase Inhibition With Lorundrostat For The Treatment Of Uncontrolled Hypertension: The Target-HTN Randomized Clinical Trial

Importance: Excess aldosterone production contributes to hypertension in both classical hyperaldosteronism and obesity-associated hypertension. Objective: To compare the safety and efficacy of lorundrostat, an aldosterone synthase inhibitor, with placebo, and characterize dose-dependent safety and efficacy. Design, Setting, and Participants: Randomized, placebo-controlled, dose-ranging, double-blind clinical trial among adults with uncontrolled hypertension taking 2 or more antihypertensive medications. A first cohort of participants with suppressed plasma renin (plasma renin activity (PRA) of less than 1.0 ng/mL/h) and elevated plasma aldosterone (greater than 1.0 ng/dL) were enrolled (n=163), with subsequent enrollment of participants with PRA greater than 1.0 ng/mL/h (n=37). Interventions: Participants were randomized to placebo or one of five doses of lorundrostat (12.5, 50, or 100 mg once daily, or 12.5 or 25 mg twice daily.) Results: Following 8 weeks of treatment in participants with suppressed PRA, dose-dependent changes in office systolic BP were observed (figure). The primary endpoint, placebo-subtracted change in modeled systolic BP was -9.6 mmHg (90% confidence interval [CI], -15.8 to -3.4, p=0.01) for the 50 mg once daily dose and -7.8 mmHg (90% CI, -14.1 to -1.5, p=0.04) for 100 mg daily. Six participants had increases in serum potassium above 6.0 mmol/L that were reversed with dose reduction or drug discontinuation. Conclusions and Relevance: Among individuals with uncontrolled hypertension, use of lorundrostat was effective at lowering blood pressure compared with placebo.