Enrollment Site Research Articles

Main Street, USA Enrollment: Community Hospital Recruitment Strategies for Diverse and Equitable Selection of Pregnant Participants in a Prospective Cohort Study [ID: 1377833

INTRODUCTION: The same factors contributing to disproportionately worse health outcomes are also barriers to inclusion in research for Black, Hispanic, and Indigenous patients. In this subanalysis of a large, multisite prospective cohort study of maternal plasma mRNA signatures and adverse pregnancy outcomes (APOs), we sought to determine whether equitable representation was aided by the inclusion of a large community hospital as an enrollment site. METHODS: Pregnant persons between 18 and 45 year old with a singleton pregnancy eligible to enroll in this IRB-approved prospective cohort study at Woman’s Hospital (Baton Rouge, Louisiana). A hybrid of indirect and direct recruitment strategies, bolstered by text message communication and gift card compensation, were deployed to facilitate enrollment that mirrored the community’s diversity. RESULTS: Two thousand five hundred twenty-two participants have been enrolled over 22 months (18% of the hospital’s eligible patient population): 41% of participants are Black, 9% are of Hispanic origin, 50% are White, and 9% Other race. This identically mirrors the demographics of the hospital obstetric patient population (38% Black, 7% Hispanic, 49% White, and 13% Other). CONCLUSION: Participants overall mirrored the diverse population served. Inclusion of study sites outside of the traditional academic setting is an effective strategy for promoting equitable access to clinical research, combating barriers to inclusion in research faced by the populations that are disproportionately affected by APOs.

PO-01-012 THE IMPACT OF CEREBRAL MICROBLEEDS ON COGNITIVE DECLINE IN PATIENTS WITH ATRIAL FIBRILLATIO

The prevalence of cerebral microbleeds is higher in patients with atrial fibrillation (AF) than in those without AF. Cognitive decline may be associated with cerebral microbleeds. We aimed to investigate the association of cerebral microbleeds with cognitive function in patients with AF. We prospectively collected 36 patients with AF and 38 non-AF controls with AF from multicenter in Taiwan. Six-monthly follow-ups were conducted with participants. Brain magnetic resonance imaging (MRI) was performed on all participants at baseline to check for cerebral microbleeds. The cognitive function of the patients was evaluated at both the baseline and follow-up visits. Generalized estimating equations were used to account for repeated measurements and different enrollment sites. The prevalence of microbleed in MRI was higher in patients with AF than the controls (Table 1). After multivariable adjustment, AF (β: -0.74, 95% CI: -1.26- -0.22) was associated with decreased cognitive function (MoCA) in short-term memory compared than non-AF controls. MRI revealed more cerebral microbleeds (β: 1.13, 95% CI: 0.04-2.22; Table 1) in AF patients than non-AF controls. In patients with AF, predictors of the declined MoCA were the presence of more microbleeds in brain MRIs, old ischemic strokes, depression, thyroid disease history, current smoking status, and alcohol consumption. The MoCA scores were higher when quality of life (QoL) in the psychological and environment domains was higher (Table 2). The prevalence of microbleed in MRI was higher in patients with AF. The MoCA score declined in AF patients with cerebral microbleeds, and was associated with old ischemic strokes, thyroid disease, smoking, and alcohol consumption. Patients at higher risk of cognitive decline should be considered for health interventions to prevent future dementia.

Well-Child Care Disparities in U.S. Military Health System.

To describe adherence rates for well-child visits among military children in the first 15 months of life and identify any disparities in adherence in a universally insured population. A retrospective cohort analysis was conducted using the Military Health System data repository which included children who were born between October 2013 and September 2016 and were eligible for TRICARE (the military health insurance program). Children were followed from zero to fifteen months of life to assess adherence with a national Health Effectiveness Data and Information Set (HEDIS) metric of 6 well visits during this period. Differences in adherence rates were evaluated across select demographic characteristics including sponsor rank, race, age, service branch, patient sex, geographic region, number of enrollment sites and provider type. Fitted logistic regression models were used to determine the probability of adherence with the HEDIS metric and identify disparities. The final cohort included 168,830 infants. Across all variables, the mean number of well visits was 6.7 with an overall adherence rate of 86%. Child beneficiaries of junior enlisted, Black, and Air Force military members had lower adherence with the HEDIS metric. Enrollment at a single site and having a pediatrician for a primary care manager was associated with higher rates of adherence. Sponsor rank, race, and service branch, along with provider type and number of enrollment sites were significantly associated with the probability of adherence. Further research should evaluate barriers to care that affect a universally insured population.

Risk factors for persistent pain after breast cancer surgery: a multicentre prospective cohort study.

Identifying factors associated with persistent pain after breast cancer surgery may facilitate risk stratification and individualised management. Single-population studies have limited generalisability as socio-economic and genetic factors contribute to persistent pain development. Therefore, this prospective multicentre cohort study aimed to develop a predictive model from a sample of Asian and American women. We enrolled women undergoing elective breast cancer surgery at KK Women's and Children's Hospital and Duke University Medical Center. Pre-operative patient and clinical characteristics and EQ-5D-3L health status were recorded. Pain catastrophising scale; central sensitisation inventory; coping strategies questionnaire-revised; brief symptom inventory-18; perceived stress scale; mechanical temporal summation; and pressure-pain threshold assessments were performed. Persistent pain was defined as pain score ≥ 3 or pain affecting activities of daily living 4months after surgery. Univariate associations were generated using generalised estimating equations. Enrolment site was forced into the multivariable model, and risk factors with p < 0.2 in univariate analyses were considered for backwards selection. Of 210 patients, 135 (64.3%) developed persistent pain. The multivariable model attained AUC=0.807, with five independent associations: age (OR 0.85 95%CI 0.74-0.98 per 5 years); diabetes (OR 4.68, 95%CI 1.03-21.22); pre-operative pain score at sites other than the breast (OR 1.48, 95%CI 1.11-1.96); previous mastitis (OR 4.90, 95%CI 1.31-18.34); and perceived stress scale (OR 1.35, 95%CI 1.01-1.80 per 5 points), after adjusting for: enrolment site; pre-operative pain score at the breast; pre-operative overall pain score at rest; postoperative non-steroidal anti-inflammatory drug use; and pain catastrophising scale. Future research should validate this model and evaluate pre-emptive interventions to reduce persistent pain risk.

Awareness and utilization of genetic testing among Hispanic and Latino adults living in the US: The Hispanic Community Health Study/Study of Latinos.

We investigated the awareness, perceived usefulness, and use of genetic testing among Hispanic and Latino individuals. Annual follow-up surveys for the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) from 2019 to April 2020 assessed participants' level of awareness and use of genetic tests to determine disease risks, likelihood of passing disease to children, disease treatment, or drug selection. They also were asked to rate the usefulness of the tests for managing a person's health on a 1 (not at all useful) to 10 (extremely useful) scale. There were 5,769 HCHS/SOL participants who completed at least one survey question. Of the target population, 55.2% was aware of at least one type of genetic test. Awareness varied between HCHS/SOL enrollment sites and was higher among individuals who had higher educational attainment and had higher incomes. Only 3.3% of the target population reported receiving one or more of the tests described. HCHS/SOL individuals rated the usefulness as 8.4, on average, with lower scores observed among U.S.-born individuals compared to individuals born outside the United States, with differences by HCHS/SOL enrollment sites. In conclusion, while awareness of genetic testing among Hispanic and Latino individuals varies by location, education, and income, perceptions about its usefulness are high while experiences with testing are rare. Results identify groups and locations that may benefit from greater outreach about the capabilities of genetic testing and precision medicine.

African American patient and caregiver attitudes and perceptions of community health workers as lay patient navigators in palliative care.

Concurrent palliative care for patients with advanced cancer has been shown to reduce physical and psychological symptoms, and improve the quality of life of patients with advanced cancer. Underutilization of palliative care services, especially among African American patients with advanced cancer, remains an important public health problem. To address this gap, we developed a community health worker (CHW) palliative care intervention for African American patients with advanced cancer, which is being formally assessed through an ongoing effectiveness-implementation trial (NCT05407844). As part of the preparatory phase of this study, we conducted qualitative interviews with African American patients with advanced cancer and their caregivers. The objective of this analysis was to explore patient and caregiver attitudes and perceptions of the CHW palliative care intervention to support African American patients with advanced cancer in accessing palliative care. We used purposive sampling to identify African American patients with advanced cancer and their informal caregivers from clinic lists and through referring oncologists. We conducted six individual and group semi-structured interviews with patients and caregivers between November 2022 and April 2023 at three enrollment sites: Johns Hopkins Hospital, TidalHealth Peninsula Regional, and University of Alabama at Birmingham Hospital. The interview guide was informed by the Consolidated Framework for Implementation Research, with a focus on the Innovation and Inner Setting domains. We used the framework method for thematic analysis. Overall, there was a lack of awareness and understanding of palliative care, due primarily to limited experiences with palliative care services among study participants. Despite this lack of familiarity, participants recognized the potential benefits of palliative care for patients with advanced cancer. All study participants were enthusiastic about the concept of patient navigation and the CHW palliative care intervention, with CHWs as lay patient navigators in palliative care. When reflecting on their own experiences, patients and their caregivers identified several areas where CHWs may have supported their cancer care, such as care coordination. Study participants viewed the CHW palliative care intervention as fulfilling a need within the African American community. Participants also made intervention delivery recommendations related to CHW characteristics, training and integration, and communication. This study provides evidence for the acceptability of a CHW palliative care intervention for African American patients with advanced cancer and their caregivers. The findings of this study have led to intervention refinement, which will enhance implementation, delivery, and sustainability of the intervention.

Abstract IA007: Achieving health equity through the All of Us research program

Abstract The All of Us Research Program is a historic, longitudinal effort to gather data from one million or more people living in the United States to accelerate research and improve health. The program seeks to engage a community of participants that reflects the diversity of the United States. Our approach to creating a diverse database has been intentional and is unique given the historical lack of underrepresentation of certain communities in biomedical research. All of Us is committed to doing things differently and is succeeding at having a transformational research program focused on diversity. All of Us has built the largest, most diverse biomedical data resource of its kind, which is being used in research that is investigating health disparities and will move us closer to achieving health equity. Currently more than 30 studies on health equity, disparities, and social determinants of health are in progress based on All of Us data. 80% of participants are from communities underrepresented in biomedical research (including racial and ethnic minorities, sexual and gender minorities, people with disabilities, and others). Additionally, nearly 50% of participants self-identify as racial and ethnic minorities. Our ability to have a diverse participant pool is in part because of our community engagement efforts and the ecosystem built to support community partners. A key component of the All of Us Research Program is the deep investments we have made in building a community engagement ecosystem to raise the public’s awareness of the program and to build lasting relationships with communities. The program has been intentional in its efforts to build an engagement ecosystem since its inception and understood that representation matters. For instance, research has not always been conducted in places where the populations reflect the diversity of the United States. With this in mind, the program was intentional in its selection and inclusion of community health centers like Federally Qualified Health Centers (FQHCs) as part of our enrollment sites and their location to ensure everyone has a seat at the table. Two important aspects of our engagement ecosystem are the Community and Provider Gateway Initiative Partners (CPGI partners) and National Community Engagement Partners. These organizations have deep reach into communities that have been historically underrepresented in biomedical research and help bridge trust and serve as program validators in communities across the country. We have more than 100 Funded Partner Organizations and 8 National Community Engagement Partners, including Stanford University School of Medicine (PrideNet), National Baptist Convention, National Alliance for Hispanic Health, FiftyForward, Delta Research and Educational Foundation, Asian Health Coalition, and American Association on Health and Disability.The purpose of this presentation is to share the community engagement ecosystem and efforts that have led to the All of Us Research Program’s success as a diverse research program, moving us closer to achieving health equity. Citation Format: Karriem S. Watson. Achieving health equity through the All of Us research program [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr IA007.

Association between COVID-19 and consistent mask wearing during contact with others outside the household-A nested case-control analysis, November 2020-October 2021.

Face masks have been recommended to reduce SARS-CoV-2 transmission. However, evidence of the individual benefit of face masks remains limited, including by vaccination status. As part of the COVID-19 Community Research Partnership cohort study, we performed a nested case-control analysis to assess the association between self-reported consistent mask use during contact with others outside the household and subsequent odds of symptomatic SARS-CoV-2 infection (COVID-19) during November 2020-October 2021. Using conditional logistic regression, we compared 359 case-participants to 3544 control-participants who were matched by date, adjusting for enrollment site, age group, sex, race/ethnicity, urban/rural county classification, and healthcare worker occupation. COVID-19 was associated with not consistently wearing a mask (adjusted odds ratio [aOR] 1.49; 95% confidence interval [CI] [1.14, 1.95]). Compared with persons ≥14 days after mRNA vaccination who also reported always wearing a mask, COVID-19 was associated with being unvaccinated (aOR 5.94; 95% CI [3.04, 11.62]), not wearing a mask (aOR 1.62; 95% CI [1.07, 2.47]), or both unvaccinated and not wearing a mask (aOR 9.07; 95% CI [4.81, 17.09]). Our findings indicate that consistent mask wearing can complement vaccination to reduce the risk of COVID-19.

Building More Bridges: Indigenous leadership in a study assessing the impact of distance to care on markers of quality HIV care in Saskatchewan

Individuals in rural and remote areas face barriers to chronic disease care, including HIV. Saskatchewan has the highest HIV incidence among Canadian provinces and 35.6% of the population lives outside of an urban centre. In this study, we explored the relationship between distance to HIV care and markers of quality HIV care in Saskatchewan as part of the Canadian Observational HIV Cohort (CANOC). We used a Two-Eyed Seeing approach and honoured the experience of Indigenous team members living with HIV. The Positive Partnership Score (PPS) was the primary outcome (including frequency of viral load and CD4 measurements, baseline CD4 count, antiretroviral medication regimen and virologic suppression). Multivariable linear regression analysis was performed with distance to care defined in two ways: (1) categorical based on distance from home to HIV specialist care and (2) road distance from CANOC enrolment site. Two hundred and seventy-six individuals were included in the analyses. Living ≤25 km from a visiting HIV specialist (where no HIV specialist lives in the community permanently) and living >100 km from the closest HIV specialist (either visiting or permanent) were both associated with lower PPS compared to living ≤25 km from where an HIV specialist practises permanently. Each 10 km further from the CANOC enrolment site was associated with a 0.01-point reduction (95% CI-0.02, 0, P = 0.024) in PPS. Through a strength-based approach that was grounded in culture, connection, land and Ceremony, we demonstrated how Indigenous people with HIV can play a key role in research. Distance from care was associated with a poorer quality of HIV care in Saskatchewan highlighting the need for better rural HIV care.

2195. Etiologies of medically attended acute respiratory infections among young Ecuadorian children prior to the start of the 2020 SARS-CoV-2 pandemic

Abstract Background Data regarding respiratory pathogen epidemiology in the tropical country of Ecuador are limited. Here, we describe the temporal patterns and etiologies of medically attended acute respiratory infections among Ecuadorean children during the 20-month period preceding the onset of the 2020 SARS-CoV-2 pandemic. Methods Children &amp;lt; 5 years old presenting to a designated outpatient clinic with at least 2 new symptoms consistent with an acute respiratory infection are eligible for enrollment. Informed consent is obtained. Demographic and clinical details are collected. A nasopharyngeal sample is collected for diagnostic testing of 22 target pathogen groups using Biofire’s Respiratory Panel v1.7 multiplex polymerase chain reaction assay. Results Of the 820 subjects enrolled between July 15, 2018 and March 15, 2020, 655 (80%) tested positive for at least one pathogen. The detection of pathogens was more likely from samples collected from children enrolled in Quito (85%) compared to Machala (76%) (p &amp;lt; 0.05). The most frequently detected pathogen groups were rhinovirus/enterovirus (46%), parainfluenza virus (14%), respiratory syncytial virus (RSV) (12%), and influenza virus (10%). Two or more pathogen groups were co-detected in 174 (27%) of the respiratory samples. Pathogen specific seasonal patterns were not observed for rhinovirus/enterovirus, adenovirus, or atypical bacteria at either site. Samples collected in Quito were positive for the detection of RSV spanning a 32-week period between November and June. In contrast, detection of RSV from samples collected in Machala spanned only a 17- week period between February and May. In Quito, influenza viruses were detected between August and February, with influenza A activity preceding that of influenza B. In Machala, the detection of influenza B virus coincided with the dry season, while detection of influenza A virus was clustered in the rainy period between January and March. Conclusion The specific etiologies and seasonality of acute respiratory tract infections among Ecuadorean children &amp;lt; 5 years of age differ by site of enrollment. Such differences in regional data can be used to optimize regional implementation of existing and soon-to-be available public health prevention measures. Disclosures Manika Suryadevara, MD, Janssen: Grant/Research Support|Merck: Grant/Research Support|Roche: Grant/Research Support.

PREHOSPITAL CRYSTALLOID RESUSCITATION: PRACTICE VARIATION AND ASSOCIATIONS WITH CLINICAL OUTCOMES.

Introduction: Although resuscitation guidelines for injured patients favor blood products, crystalloid resuscitation remains a mainstay in prehospital care. Our understanding of contemporary prehospital crystalloid (PHC) practices and their relationship with clinical outcomes is limited. Methods: The Pragmatic, Randomized Optimal Platelet and Plasma Ratios trial data set was used for this investigation. We sought to identify factors associated with PHC volume variation and hypothesized that higher PHC volume is associated with worse coagulopathy and a higher risk of acute respiratory distress syndrome (ARDS) but a lower risk of acute kidney injury (AKI). Subjects were divided into groups that received <1,000 mL PHC (PHC<1,000) and ≥1,000 mL PHC (PHC≥1,000); initial laboratory values and outcomes (ARDS and AKI risk) were summarized with medians and interquartile ranges or percentages and compared using Wilcoxon rank-sum tests and chi-square tests. The primary outcome was ARDS risk. Multivariable regression was used to characterize the association of each 500 mL aliquot of PHC with initial laboratory values and clinical outcomes. Results: PHC volume among study subjects (n = 680) varied (median, 0.3 L; interquartile range, 0-0.9 L) with weak associations demonstrated among prehospital hemodynamics, intubation, Glasgow Coma Score, and Injury Severity Score (0.008 ≤ R2 ≤ 0.09); prehospital time and enrollment site explained more variation in PHC volume with R2 values of 0.2 and 0.54, respectively. Compared with PHC<1,000, PHC≥1,000 had higher INR, PT, PTT, and base deficit and lower hematocrit and platelets. The proportion of ARDS in the PHC≥1,000 group was higher than PHC<1,000 (21% vs. 12%, P < 0.01), whereas the rate of AKI was similar between groups (23% vs. 23%, P = 0.9). In regression analyses, each 500 mL of PHC was associated with increased INR and PTT, and decreased hematocrit and platelet count (P < 0.05). Each 500 mL of PHC was associated with increased ARDS risk and decreased AKI risk (P < 0.05). Conclusion: PHC administration correlates poorly with prehospital hemodynamics and injury characteristics. Increased PHC volume is associated with greater anemia, coagulopathy, and increased risk of ARDS, although it may be protective against AKI.

52 Methodology for Measuring Health-Related Quality of Life Impact of Disasters

52 Methodology for Measuring Health-Related Quality of Life Impact of Disasters

A cross-sectional study of participant recruitment rates in published phase III influenza therapeutic randomized controlled trials conducted in the clinical setting

ObjectiveA recent academic-government partnership demonstrated the feasibility of utilizing Emergency Departments (ED) as a primary site for subject enrollment in clinical trials and achieved high rates of recruitment in two U.S. EDs. Given the ongoing need to test new therapeutics for influenza and other emerging infections, we sought to describe the historical rates of participant recruitment into influenza Phase III therapeutic RCTs in various clinical venues, including EDs. Study designA cross-sectional study was performed of influenza therapeutic Phase III RCTs published in PubMed, Embase, Scopus, and Clinicaltrials.gov from January 2000 to June 2019. Main outcomeTo estimate the weighted-average number of influenza-positive participants enrolled per site per season in influenza therapeutic RCT conducted in clinical settings, and to describe basic trial site characteristics. Results47 (0.7%) of 7008 articles were included for review of which 43 of 47 (91%) included information regarding enrollment sites; of these, 2 (5%) recruited exclusively from EDs with the remainder recruiting from mixed clinical settings (inpatient, outpatient, and ED). The median enrollment per study was 326 (IQR: 110, 502.5) with a median of 11 sites per study (IQR: 2, 59.5). Included studies reported a median of 201 (IQR: 74, 344.5) confirmed influenza-positive participants per study. The pooled number of participants enrolled per site per season was 11 (95% CI: 10, 12). The pooled enrollment numbers per clinical site after excluding the two ‘ED only recruitment’ studies were less [10.7 (95% CI: 9.9, 11.6)] than the pooled enrollment numbers per clinical site for the two ‘ED only recruitment’ studies [89.5 (95% CI 89.2–89.27)]. Conclusion and relevancePublished RCTs evaluating influenza therapeutics in clinical settings recruit participants from multiple sites but enroll relatively few participants, per site, per season. The few ED-based studies reported recruited more subjects per site per season. Untapped opportunities likely exist for EDs to participate and/or lead therapeutic RCTs for influenza or other emerging respiratory pathogens.

Degree of Polypharmacy and Cognitive Function in Older Women with HIV.

The number of people with HIV (PWH) experiencing age-associated comorbidities including those treated with medications and cognitive impairment is increasing. We examined associations between polypharmacy and cognition in older women with HIV (WWH) given their vulnerability to this comorbidity. Cross-sectional analysis capitalizing on Women's Interagency HIV Study data collected between 2014 and 2017. WWH meeting the following criteria were analyzed: age ≥50 years; availability of self-reported non-antiretroviral therapy (ART) medications data; and neuropsychological data. The number of non-ART medications used regularly in the prior 6 months was summed. Polypharmacy was categorized as none/low (0-4), moderate (5-9), or severe (≥10). Multivariable linear regression analyses examined polypharmacy-cognition (T-score) associations in the total sample and among virally suppressed (VS; < 20 copies/mL)-WWH after covariate adjustment for enrollment site, income, depressive symptoms, substance use (smoking, heavy alcohol, marijuana, crack, cocaine, and/or heroin), the Veterans Aging Cohort Study index (indicators of HIV disease and organ system function, hepatitis C virus serostatus), ART use, nadir CD4 count, and specific ART drugs (efavirenz, integrase inhibitors). We included 637 women (median age = 55 years; 72% Black). Ninety-four percent reported ART use in the past 6 months and 75% had HIV RNA <20 copies/mL. Comorbidity prevalence was high (61% hypertension; 26% diabetes). Moderate and severe polypharmacy in WWH were 34% and 24%. In WWH, severe polypharmacy was associated with poorer executive function (p = .007) and processing speed (p = .01). The same pattern of findings remained among VS-WWH. Moderate polypharmacy was not associated with cognition. Moderate and severe polypharmacy were common and associated with poorer executive function and processing speed in WWH. Severe polypharmacy may be a major contributor to the persistence of domain-specific cognitive complications in older WWH above and beyond the conditions that these medications are used to treat.

SURVEY OF EXPERIENCES AND BARRIERS TO DENTAL CARE POST HEAD AND NECK CANCER

<h3>Objectives</h3> As the population of patients with head and neck cancer (HNC) treated with radiation therapy (RT) increases, along with increased longevity, the oral health of patients posttreatment merits increased attention. Patients with HNC experience changes to the oral cavity and surrounding structures, putting them at increased risk of oral disease, transiently or permanently, after RT. Thus, consistent, comprehensive dental care is crucial to maintaining oral health and to preventing or treating oral complications after RT treatment. Past studies reported about 50% of patients see a dentist post HNC. Prior surveys have assessed topics such as patient need for help with dental health, patients' unmet needs, treatment effects on quality of life, perception of financial impact, access to dentists, and oncologists' dental care awareness. Many of these surveys were done outside of the United States and included limited numbers of patients with HNC. This survey aims to investigate the experiences and barriers to dental care faced by patients in an established, multi-institutional U.S. HNC cohort. <h3>Study Design</h3> A literature review was performed and a survey was created by a resident (E.J.T.) and was reviewed by OraRad investigators and other oral medicine specialists. The survey was administered to patients at least 5 years post HNC in the OraRad cohort, a multicenter, prospective cohort study established through a cooperative agreement with National Institute of Dental and Craniofacial Research (NIDCR). The survey addressed patient knowledge of/beliefs about dental care post HNC, information/recommendations given to patients by a dentist/oncologist, perception of the dentist's understanding/knowledge of HNC, financial limitations to dental care, and physical symptoms. The research coordinators at each enrollment site in the OraRad Consortium contacted patients who had previously agreed to be contacted about future research projects related to HNC. The surveys were completed either by phone interview or physically completed and mailed by the patients. <h3>Results</h3> One hundred forty surveys have thus far been completed of 572 from the original cohort, which includes 421 participants who completed the final 24-month follow-up visit. Almost all respondents (n = 129; 92%) either strongly agreed (67%) or agreed (25%) that they understand the effects of cancer and its treatment on the teeth, mouth, and jaws. The majority (n = 107; 76.4%) verified that their cancer doctors have asked if they were seeing a dentist regularly after cancer treatment and almost all respondents (n = 138; 97%) had seen a dentist after cancer treatment, with 131 (95%) seeing a dentist 2 or more times per year. The majority (n = 110; 80%) either strongly agreed (51%) or agreed (29%) that their dentist provided them with information on how to keep teeth, mouth, and jaws healthy after cancer treatment. Nine participants (6%) reported that they declined or not sought dental care because it is too expensive and only 5 noted that transportation prevented or made it hard to get dental care. The majority reported dry mouth (n = 108; 77%). Other sequelae were problems swallowing (n = 52; 37%), limited opening (n = 41; 29%), dental caries (n = 33;24%), and difficulty keeping their mouth open during dental procedures (n = 25; 18%). Only 39 (28%) reported no symptoms. Only 3 participants (2%) had missed or canceled a dental appointment owing to symptoms. <h3>Conclusion</h3> The majority of post HNC OraRad patients who responded to this survey have an understanding of the oral sequelae of cancer and cancer treatment. Most were educated by their dentist and were compliant with routine dental care, contrasting with previous surveys that found likely insufficient patient education and speculated that patient misunderstanding of the importance of dental evaluation had led to canceling of appointments and dissatisfaction with dental care. Suspected barriers of transportation, finances, and symptoms post HNC are largely overcome or nonexistent in this dentally compliant HNC group. Further assessment will compare respondents to nonrespondents from the original OraRad cohort to determine baseline differences in socioeconomic status, because this can have a major impact on survey response. Seventy-seven percent of patients reported dry mouth at approximately 5 years post-RT, underscoring the chronic nature of this symptom.

Use of angiotensin converting enzyme inhibitors is associated with reduced risk of late bladder toxicity following radiotherapy for prostate cancer

Background and purposeGenome-wide association studies (GWAS) of late hematuria following prostate cancer radiotherapy identified single nucleotide polymorphisms (SNPs) near AGT, encoding angiotensinogen. We tested the hypothesis that patients taking angiotensin converting enzyme inhibitors (ACEi) have a reduced risk of late hematuria. We additionally tested genetically-defined hypertension. Materials and methodsProstate cancer patients undergoing potentially-curative radiotherapy were enrolled onto two multi-center observational studies, URWCI (N = 256) and REQUITE (N = 1,437). Patients were assessed pre-radiotherapy and followed prospectively for development of toxicity for up to four years. The cumulative probability of hematuria was estimated by the Kaplan-Meier method. Multivariable grouped relative risk models assessed the effect of ACEi on time to hematuria adjusting for clinical factors and stratified by enrollment site. A polygenic risk score (PRS) for blood pressure was tested for association with hematuria in REQUITE and our Radiogenomics Consortium GWAS. ResultsPatients taking ACEi during radiotherapy had a reduced risk of hematuria (HR 0.51, 95%CI 0.28 to 0.94, p = 0.030) after adjusting for prior transurethral prostate and/or bladder resection, heart disease, pelvic node radiotherapy, and bladder volume receiving 70 Gy, which are associated with hematuria. A blood pressure PRS was associated with hypertension (odds ratio per standard deviation 1.38, 95%CI 1.31 to 1.46, n = 5,288, p < 0.001) but not hematuria (HR per standard deviation 0.96, 95%CI 0.87 to 1.06, n = 5,126, p = 0.41). ConclusionsOur study is the first to show a radioprotective effect of ACEi on bladder in an international, multi-site study of patients receiving pelvic radiotherapy. Mechanistic studies are needed to understand how targeting the angiotensin pathway protects the bladder.

Social determinants associated with loss of an eye in the United States using the All of Us nationwide database

ABSTRACT Purpose To identify common factors associated with the loss of an eye using the NIH All of Us database. Methods In this case-controlled study, we extracted electronic health record and socio-demographic data for 231 cases of eye loss from All of Us enrollment sites. Controls (N = 924) matched the demographic characteristics of the 2020 United States Census. Bivariate analyses and multivariable logistic regression identified variables significantly associated with increased odds of eye loss. Outcome measures Medical and social determinants associated with increased odds of losing an eye. Results Among cases, the average age (standard deviation) was 60.1 (14.4) years. The majority (125, 54.1%) were male. 87 (37.7%) identified as African American, and 49 (21.2%) identified as Hispanic or Latino. Loss of eye was more likely in those with ocular tumor (odds ratio [OR] 421.73, 25 95% confidence interval [CI] 129.81–1959.80, p < .001), trauma (OR 13.38, 95% CI 6.64–27.43, p < .001), infection (OR 11.46, 95% CI 4.11–32.26, p = .001) or glaucoma (OR 8.33, 95% CI 4.43– 15.81, p < .001). African American (OR 2.39, 95% CI 1.39–4.09, p = .002) and Hispanic or Latino (OR 1.80, 95% CI 1.01–3.15, p = .04) participants were disproportionately affected. Conclusions Racial and ethnic disparities exist among those with loss of an eye from underlying conditions. Addressing health inequities may mitigate the risk of this morbid outcome.

Racial Disparities in Access to Prostate Cancer Clinical Trials: A County-Level Analysis.

BackgroundAfrican American men have a higher burden of prostate cancer compared with other populations. We sought to determine if they experience disparities in access to prostate cancer clinical trials.MethodsWe created a database of all US counties by linking prostate cancer clinical trial data with county-level socioeconomic, demographic, and health-care facility data derived from several external data sources. Using this data linkage, we examined 2 potential access barriers. We investigated the relationship between the proportion of African Americans and access to cancer facilities, adjusting for county population size and other characteristics. Additionally, among counties with cancer facilities, we investigated the relationship between the proportion of African Americans and number of available prostate cancer trials per capita per year. We addressed these questions using logistic and negative binomial regression, respectively.ResultsBetween 2008 and 2015, 613 prostate cancer trial sites were found among 3145 US counties. Counties with a higher proportion of African Americans were less likely to have cancer facilities (adjusted odds ratio = 0.85, 95% confidence interval = 0.78 to 0.92). Among counties with cancer facilities, those with a higher proportion of African Americans had statistically significantly fewer prostate cancer trials per capita per year (rate ratio per 10% increase in African Americans = 0.90, 95% confidence interval = 0.83 to 0.96).ConclusionsCounties with higher proportions of African Americans seem less likely to have access to cancer facilities. Among counties with cancer facilities, those with higher proportions of African Americans appear to have fewer prostate cancer trials available per capita per year. Clinical trials in prostate cancer therapy should ensure adequate availability of enrollment sites in regions with high concentrations of African Americans.

1005. COVID-19 At-Home Capillary Blood Specimen Collection Pilot – Gaining Insight into Independent Self- Collection of Blood Specimens and COVID-19 Within the Veteran Population

BackgroundThe VA Million Veteran Program (MVP) studies what factors influence Veteran health. Current procedures involve collection of venous blood at MVP enrollment sites. To examine home specimen collection options, MVP performed a pilot study comparing two blood specimen collection devices and evaluated SARS-CoV-2 antibody assays to determine known COVID-19 infection or vaccination.MethodsA sub-sample of MVP Veteran participants were asked to self-collect a capillary blood specimen using the Neoteryx Mitra Clamshell (up to 120uL dried blood) or Tasso-SST (up to 200uL liquid blood) per the vendor instructions. Veterans were randomly assigned to a device prior to consent. Eligibility included 30% of Veterans with known COVID-19 diagnosis or vaccination and sampling time was variable from these events. Veterans rated their device experience and shipped collected specimens directly to an MVP laboratory. Mitra tip (4) blood was eluted in 1 mL of 0.9% normal saline for 1 hour at room temperature shaking at 300 rpm. Tasso tubes were centrifuged per vendor instructions. All samples were stored at -80°C until tested with SARS-Cov-2 antibody (Ab) assays (InBios Spike IgG, BioRad Nucleocapsid (NC) Total Ab, Abbott NC IgG, and Abbott Spike IgG II) per vendor instructions. Results312 MVP participants consented to the pilot (52%) of which 136 (43.6%) were sent Mitra and 176 (56.4%) were sent Tasso-SST (Table 1). Participants rated the Mitra Tasso-SST equally on average as 4.4 on a 0-5 usability scale. The Abbott IgG II assay had the highest sensitivity across both devices (87% Mitra and 98% Tasso-SST) for detecting known COVID infection and/or vaccination. The InBios IgG assay with the Tasso-SST had the best sensitivity (97%) and specificity (80%) for detecting known COVID-19 infection and/or vaccination (Table 2).Table 1. COVID-19 At-Home Capillary Blood Specimen Collection Pilot Outcomes ConclusionVeterans successfully collected their own specimens and had no strong preference for either device. The Tasso-SST combined with the InBios Spike IgG assay provided the highest combination of sensitivity and specificity. Limitations included one collection device per subject, varied timing of testing, unknown infection or vaccination status among some, and Tasso collection volume and Mitra whole blood dilution may have affected comparison across assays or performance.Disclosures All Authors: No reported disclosures

EHR-based cohort assessment for multicenter RCTs: a fast and flexible model for identifying potential study sites.

ObjectiveThe Recruitment Innovation Center (RIC), partnering with the Trial Innovation Network and institutions in the National Institutes of Health-sponsored Clinical and Translational Science Awards (CTSA) Program, aimed to develop a service line to retrieve study population estimates from electronic health record (EHR) systems for use in selecting enrollment sites for multicenter clinical trials. Our goal was to create and field-test a low burden, low tech, and high-yield method.Materials and MethodsIn building this service line, the RIC strove to complement, rather than replace, CTSA hubs’ existing cohort assessment tools. For each new EHR cohort request, we work with the investigator to develop a computable phenotype algorithm that targets the desired population. CTSA hubs run the phenotype query and return results using a standardized survey. We provide a comprehensive report to the investigator to assist in study site selection.ResultsFrom 2017 to 2020, the RIC developed and socialized 36 phenotype-dependent cohort requests on behalf of investigators. The average response rate to these requests was 73%.DiscussionAchieving enrollment goals in a multicenter clinical trial requires that researchers identify study sites that will provide sufficient enrollment. The fast and flexible method the RIC has developed, with CTSA feedback, allows hubs to query their EHR using a generalizable, vetted phenotype algorithm to produce reliable counts of potentially eligible study participants.ConclusionThe RIC’s EHR cohort assessment process for evaluating sites for multicenter trials has been shown to be efficient and helpful. The model may be replicated for use by other programs.