Underrepresented Patients Research Articles

Abstract P4-07-52: Caloric Restriction for Oncology Research (CaReFOR): Assessing dietary adherence and outcomes in African American patients during breast cancer treatment

Abstract Purpose: Epidemiologic and clinical evidence have shown an association between obesity and increased risk for breast cancer (BC) incidence and mortality. Data from human and animal studies support a potential role for weight loss in counteracting tumor-promoting properties of obesity in BC. However, dietary intervention clinical trials often show low patient adherence, especially among African American (AA) women compared to Caucasian (CC) women. They also show that AA women are disproportionately obese and lose less weight during behavior lifestyle interventions compared to CC with similar risk factors. We evaluated the efficacy and feasibility of a 10-week caloric restricted diet in patients undergoing radiation and have performed analysis to determine if adherence to dietary alterations is feasible in underrepresented patients. Methods: In an IRB approved clinical trial, we determined the feasibility and toxicity of dietary intervention during radiation in breast cancer patients 18 years and older who were undergoing breast conservation therapy with T1-2N0 cancers. The dietary intervention consisted of caloric intake reduction of 25% from baseline for a total of 10 weeks during their six-week radiation treatment which was administered to the whole breast to a dose of 50Gy with a 10Gy boost to the tumor bed. To optimize adherence to caloric restriction (CR), patients received personalized counseling, maintained food diaries, and were educated on behavioral modifications at weekly visits. To characterize the effects of CR, baseline physiologic and blood parameters were collected and compared with post intervention measurements and samples. Biometric and biological data collected during the study comparing compliant participants before and after the CaReFOR intervention was stratified by race and analyzed via two-sample paired t-test. The difference between AA and CC study participants was determined to be significant if the calculated p-value was less than < 0.05 (CI 95%). Results: A total of 32 female patients were enrolled in the CaReFOR trial, 16 were AA and 16 were CC. Participant demographics were similar across age, primary tumor size (pT), nuclear grade, and hormone receptor status. Evaluation of patients’ baseline diet demonstrated similar macronutrients across races, with AA showing less fruit/vegetable and grains. AA patients were more overweight compared to their CC counterparts. They also showed a more inflamed state compared to CC patients. The baseline inflammatory biomarker levels for ESR and cholesterol were significantly higher while adiponectin was significantly lower in AA than that of CC patients. The trends for insulin, HbA1c, and leptin were also higher for AA compared to CC. Following the 10-week diet, AA patients (87.3%) were more compliant than CC’s (81.3%). Both AA and CC patients lost weight during the trial, with AA having a significant loss in body fat and gain in muscle mass compared to CC. Similarly, after completing the CR diet, biological inflammatory markers improved in AA and CC patients. Particularly, in AA, there was a significant decrease in cholesterol levels, while insulin, leptin, and ESR serum levels trended downwards, suggesting a decreased inflammatory state. Conclusions: Contrary to published studies, we found AA patients are successful in adhering to dietary alterations and have a benefit with respect to physiologic and biologic parameters. Our dietary intervention was able to positively affect our AA patients adverse baseline factors such as obesity and inflammation. Future studies should consider dietary alterations as a possible means to decrease AA patient disparate outcomes in breast cancer. Citation Format: Siani Harding, Adeseye Adekeye, Edith P. Mitchell, Nicole Simone. Caloric Restriction for Oncology Research (CaReFOR): Assessing dietary adherence and outcomes in African American patients during breast cancer treatment. [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-07-52.

Abstract OT2-05-01: FLEX: 30K Full Transcriptome, Real-World Evidence Database for Early-Stage Breast Cancer, and Investigator-Initiated Protocols

Abstract FLEX: 30K Full Transcriptome, Real-World Evidence Database for Early-Stage Breast Cancer, and Investigator-Initiated Protocols BACKGROUND: Genomic signatures, such as the 70-gene MammaPrint, provide additional prognostic information for early-stage breast cancer (EBC), such as tumor metastatic potential, and expand the available information clinicians and patients require for shared treatment decision making beyond the standard clinicopathologic factors. EBC tumors are further stratified into clinically actionable subtypes by molecular assays such as the 80-gene molecular profiling assay BluePrint, improving pathological complete response rates (pCR) and outcomes as evidenced by a number of recent trials. The ongoing FLEX Study (NCT03053193) is designed to expand the genomic information available for EBC cases, and to increase the speed of data generation for rare and underserved research areas. To date, FLEX is the largest international multicenter real-world evidence (RWE) EBC registry, with more than 10,000 patients enrolled in fewer than five years since opening. FLEX pairs full genome data with more than 800 clinical data points collected over 10 years of follow up to provide the most comprehensive big data database available for early-stage breast cancer. The FLEX enrollment has a goal of a minimum of 30,000 patients within 10 years. METHODS: The FLEX study is a multicenter, prospective, observational trial for patients ≥18 years old with histologically proven stage I-III invasive breast cancer that is node negative or positive (up to three nodes) who receive MammaPrint, with or without BluePrint as standard of care management. Patients consent to the collection of clinically annotated full transcriptome data. Additionally, this study protocol allows physicians to investigate targeted populations or clinical trial investigator-initiated studies (IIS) upon approval by a peer-driven Scientific Review Committee. As patients enrolled in the FLEX study meet all eligibility criteria for inclusion no additional consent is required. The FLEX enrollment has already surpassed 1/3 of set target goal. As of April 2022, the trial has surpassed 10,000 patients enrolled at nearly 100 trial sites across the US and Europe, Middle East and Africa (EMEA). To date, there have been 36 publications in international scientific congresses with 39 FLEX IIS and in progress. With over 250 active and collaborating physicians leveraging the shared infrastructure, the IIS have enabled the ability to address disparities in treatment to underrepresented populations, rare subtypes, age, and patient centered specific topics. Current and future questions investigated via this platform will continue to strive to improve outcomes for early-stage breast cancer patients. Citation Format: Alejandra Perez, Hannah Linden, Nathalie Johnson, Sami Diab, Chirag Jani, Chelsea D. Gawryletz, Richard Fine, Laura Lawson, Megan Baker, Victoria Poillucci, Lisa E. Blumencranz, William Audeh. FLEX: 30K Full Transcriptome, Real-World Evidence Database for Early-Stage Breast Cancer, and Investigator-Initiated Protocols [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT2-05-01.

Critical interactions between race and the highly granular area deprivation index in liver transplant evaluation.

Neighborhood socioeconomic deprivation may have important implications on disparities in liver transplant (LT) evaluation. In this retrospective cohort study, we constructed a novel dataset by linking individual patient-level data with the highly granular Area Deprivation Index (ADI), which is advantageous over other neighborhood measures due to: specificity of Census Block-Group (versus Census Tract, Zip code), scoring, and robust variables. Our cohort included 1377 adults referred to our center for LT evaluation 8/1/2016-12/31/2019. Using modified Poisson regression, we tested for effect measure modification of the association between neighborhood socioeconomic status (nSES) and LT evaluation outcomes (listing, initiating evaluation, and death) by race and ethnicity. Compared to patients with high nSES, those with low nSES were at higher risk of not being listed (aRR=1.14; 95%CI 1.05-1.22; p<.001), of not initiating evaluation post-referral (aRR=1.20; 95%CI 1.01-1.42; p=.03) and of dying without initiating evaluation (aRR=1.55; 95%CI 1.09-2.2; p=.01). While White patients with low nSES had similar rates of listing compared to White patients with high nSES (aRR=1.06; 95%CI .96-1.17; p=.25), Underrepresented patients from neighborhoods with low nSES incurred 31% higher risk of not being listed compared to Underrepresented patients from neighborhoods with high nSES (aRR=1.31; 95%CI 1.12-1.5; p<.001). Interventions addressing neighborhood deprivation may not only benefit patients with low nSES but may address racial and ethnic inequities.

Increased utilization of prostate-specific membrane antigen (PSMA)-targeted radionuclide therapy (PSMA-TRT) in African American (AA) patients at an academic medical center.

36 Background: At Weill Cornell Medicine (WCM), we have had a research program utilizing anti-PSMA mAb J591 since the year 2000. With the addition of PSMA ligand-based therapies in 2017, we have enrolled around 300 patients on investigational PSMA-TRT clinical trials. Since the approval of 177Lu-PSMA-617 (Pluvicto; Lu-177 vipivotide tetraxetan), we began standard-of-care (SOC) treatment, co-enrolling willing patients into a research registry. Recognizing the low numbers of AA patients enrolled on therapeutic clinical trials in the U.S., we made a concerted effort to increase the number of AA patients with prostate cancer (PC) enrolled on clinical trials at WCM. We retrospectively assessed the demographic data of patients enrolled on PSMA-TRT clinical trials to determine changing patterns of enrollment, and to determine if our efforts have improved access to these novel treatments for this under-represented, but high-risk population of patients. Methods: We collected demographic data (namely race and ethnicity) on patients with PC from WCM who were included on our PSMA-TRT investigational clinical trial databases or enrolled on our SOC 177Lu-PSMA-617 research registry. We used self-reported race and, when not available (due to patient death or loss of follow-up), demographic information documented in the medical record. Patients were grouped into 5-year cohorts based on either the date of consent for trial enrollment, or the start date of PSMA-TRT treatment (based on available information). Institutional tumor registry data was used as a comparator to assess the total percentage of AA patients with PC seen at WCM. Results: The percentages of patients included on PSMA-TRT clinical trials at WCM who were identified as AA were as follows: 2000-2004: 3.1% (2/65), 2005-2009: 5.1% (3/59), 2010-2014: 6.1% (2/33), and 2015-2019: 5.9% (5/85). The percentage of AA patients on PSMA-TRT studies from 2020 through July 2022 was 18.2% (16/88, inclusive of 8/72 investigational TRT subjects and 8/16 SOC registry participants). The total percentages of AA patients seen at Cornell based upon analysis of our tumor registry data were as follows: 2000-2004: 10.5% (182/1728), 2005-2009: 6.9% (250/3607), 2010-2014: 10% (326/3255), 2015-2019: 11.5% (278/2413), and 2020: 14.1%. Tumor registry data for 2021-present were not yet available. Conclusions: The percentage of AA patients on investigational PSMA-TRT trials at our institution notably increased from 2000-2019 (3.1%-6.1%) to 2020-2022 (11.1%). Moreover, 50% of those treated with 177Lu-PSMA-617 since its FDA approval and co-enrolled on our research registry identified as AA. These data suggest that outreach and increasing access to AA patients for novel PC treatment such as PSMA-TRT can result in increased numbers of underrepresented patients enrolling on clinical trials and receiving the most modern standards of care (i.e., PSMA-TRT).

Priorities to Promote Participant Engagement in the Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network.

Engaging diverse populations in cancer genomics research is of critical importance and is a fundamental goal of the NCI Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network. Established as part of the Cancer Moonshot, PE-CGS is a consortium of stakeholders including clinicians, scientists, genetic counselors, and representatives of potential study participants and their communities. Participant engagement is an ongoing, bidirectional, and mutually beneficial interaction between study participants and researchers. PE-CGS sought to set priorities in participant engagement for conducting the network's research. PE-CGS deliberatively engaged its stakeholders in the following four-phase process to set the network's research priorities in participant engagement: (i) a brainstorming exercise to elicit potential priorities; (ii) a 2-day virtual meeting to discuss priorities; (iii) recommendations from the PE-CGS External Advisory Panel to refine priorities; and (iv) a virtual meeting to set priorities. Nearly 150 PE-CGS stakeholders engaged in the process. Five priorities were set: (i) tailor education and communication materials for participants throughout the research process; (ii) identify measures of participant engagement; (iii) identify optimal participant engagement strategies; (iv) understand cancer disparities in the context of cancer genomics research; and (v) personalize the return of genomics findings to participants. PE-CGS is pursuing these priorities to meaningfully engage diverse and underrepresented patients with cancer and posttreatment cancer survivors as participants in cancer genomics research and, subsequently, generate new discoveries. Data from PE-CGS will be shared with the broader scientific community in a manner consistent with participant informed consent and community agreement.

Abstract TP80: Regional Trends And Variation In Mortality By Subgroups Following Mechanical Thrombectomy In Geriatric Acute Ischemic Stroke-related Hospitalizations In Urban Facilities, 2016-2019

Background: Mechanical thrombectomy (MT) has been proven to be a successful treatment option for patients with acute ischemic stroke (AIS) in numerous randomized controlled trials. The majority of trials underrepresent patients aged 70 and above, and there is little contemporary data on regional trends and variation in mortality. Methods: This retrospective study using the National Inpatient Sample (2016-2019) seeks to identify any regional relationships between geriatric patients' in-hospital mortality after MT for AIS at urban facilities and trends in inpatient mortality. Regional Inpatient mortality based on sex and race and trends between 2016 and 2019 were assessed. Results: Our study group consisted of 52455 AIS-MT admissions (median 78 yrs, 57.1% male, 77.2% white, 89.6% Medicare enrollees) with a 14.1% inpatient mortality rate. Despite having a lower comparative burden of traditional CVD risk factors, the hospitals from the Northeast had a higher inpatient mortality rate (17.2%, n=1650) and risk (adjusted OR:1.25, 95% CI:1.03-1.51) than the other regions. Similar trends were observed in male (18.1%), females (16.6%), white (17.3%) and black (13.8%) participants (P&lt;0.001) undergoing AIS-MT. Highest inpatient mortality among Hispanics was linked to Midwest-based participants (16.2%) without regional variation in rates for Asians. There were declining trends in mortality between 2016 to 2019 in West region without any change in other regions (from 14.0% to 11.5%, ptrend=0.002) (Fig. 1) . Conclusion: Among demographically comparable geriatric patients with AIS undergoing MT in the US, the Northeast region admissions showed the highest inpatient mortality even after controlling for confounding factors with a relatively lower burden of CVD risk factors. This disparity warrants further research to validate these findings.

Ethical Considerations Regarding Financial Incentives in Plastic Surgery-Related Health Research.

Introduction: To recruit enough patients to achieve adequate statistical power in clinical research, investigators often rely on financial incentives. The use of these incentives, however, remains controversial as they may cause patients to overlook risks associated with research participation. This concern is amplified in the context of plastic surgery where aesthetic procedures are often more desirable and are not typically covered by public or private insurance plans. Despite this, the ethical debate regarding the use of incentives has largely been absent from plastic surgery journals; therefore, efforts to summarize the existing literature in the context of plastic surgery are necessary. Methods: A narrative review of the peer-reviewed published literature was performed to identify existing articles pertaining to financial incentives in plastic surgery-related health research. Results: While incentives have the potential to improve sample sizes and promote the recruitment of under-represented patient populations, undue inducement and biased recruitment are possible. At present, there exists a paucity of empirical evidence to substantiate this. Efforts should be taken by investigators and research ethics boards (REBs) to limit the potential negative impacts of monetary compensation. Investigators should place reasonable limits on the value of incentives as well as select models associated with lower risks of undue influence and enrollment bias. When financial remuneration is offered, additional care should be taken by investigators to ensure participants are adequately informed of the risks associated with research participation. Conclusion: Current best practice recommendations suggest that proposals submitted to REBs justify the incentives used. Information regarding incentives should also be included within study consent forms and communicated as part of the informed consent process.

Racial and Ethnic Composition of Neonatal Nurse Practitioner Faculty and Students in the United States.

Neonatal nurse practitioners have a strong presence in the neonatal intensive care unit and are primed to lead efforts to induce change related to health disparities. Underrepresented minority nurse practitioners offer valuable perspectives in the care of underrepresented minority patients. However, there remains a current racial and ethnic discordance between neonatal providers and patients. Efforts to eliminate health disparities must begin before nursing school. The current racial and ethnic composition of neonatal nurse practitioner faculty in comparison to students in the United States is unknown. The purpose of this study was to determine the racial and ethnic composition of neonatal nurse practitioner faculty and students in the United States and contrast this data with available data for the racial and ethnic composition of the neonatal intensive care unit patient population. This cross-sectional study used a nonexperimental survey to describe the racial and ethnic composition of neonatal nurse practitioner faculty and students in the United States. There was no significant difference in the racial and ethnic composition between neonatal nurse practitioner faculty and students. There were significant differences for all race distributions between neonatal nurse practitioner students and neonatal intensive care unit admissions. The discordance between neonatal nurse practitioner students and neonates in the neonatal intensive care unit is important in addressing disparities and begins before nursing school. Identification of barriers and strategies for recruitment and retention of underrepresented minority nursing students and faculty is needed. https://journals.lww.com/advancesinneonatalcare/pages/video.aspx?v=62.

Qualitative study of Oncology Clinicians' Perceptions of Barriers to Offering Clinical Trials to Underserved Populations.

Cancer clinical trials represent the "gold standard" for advancing novel cancer therapies. Optimizing trial participation is critical to ensuring the generalizability of findings across patients, yet trial enrollment rates, particularly among minority and socioeconomically disadvantaged populations, remain suboptimal. We conducted in-depth interviews with oncologists at a large academic medical center to explore their (1) attitudes and perceived barriers to offering clinical trials to minority and socioeconomically disadvantaged patients, and (2) recommendations for improving the enrollment of minority and socioeconomically disadvantaged patients in cancer clinical trials. Of 23 medical oncologists approached, 17 enrolled (74% response rate; mean age = 47; female = 42%; White = 67%). Content analysis revealed several barriers to enrollment: (1) ethical dilemmas; (2) ambivalence about trial risks and benefits; and (3) concern about patient well-being. Concerns about the legitimacy of informed consent, perceived lack of equipoise, and fear of personal bias influenced clinicians' decisions to recommend trials during treatment discussions. Concerns about creating an imbalance between trial risks and benefits among patients with high-level needs, including patients with literacy, psychiatric, and other socioeconomic vulnerabilities, impacted clinicians' enthusiasm to engage in trial discussions. Clinicians identified patient, provider, and system-level solutions to address challenges, including increasing patient and clinician support as well as involving external personnel to support trial enrollment. Findings reveal multi-level barriers to offering cancer clinical trials to underrepresented patients. Targeted solutions, including system level changes to support clinicians, patient financial support, and implementation of clinical trial navigation programs were recommended to help reduce access barriers and increase enrollment of underrepresented patients into cancer clinical trials.

Abstract A028: Exploring age and race/ethnic associations with the multiple dimensions of pain among cancer patients receiving home hospice care

Abstract Aim: Racial disparities in pain are well known, but most hospice studies included few underrepresented minority patients, which limits understanding of pain disparities among cancer patients receiving hospice care. Our study purpose was to explore age and racial/ethnic associations with the sensory, affective, evaluative, and temporal dimensions of cancer pain in the hospice setting. Methods: We analyzed control group data from a stepped-wedge randomized control trial of the PAINRelieveIt app. 150 home hospice patients with a variety of cancers (mean age 68.0±14.6 years, 52% female, 44% White, 37% Black, 19% Hispanic) completed PAINReportIt, an electronic McGill Pain Questionnaire, on an internet-enabled tablet at baseline and 1 week later. We compared racial/ethnic groups for age (ANOVA) and gender (Chi square) differences. We also conducted regression analyses of baseline and posttest sensory pain (current pain intensity [0-10], worst pain intensity [0-10], Pain Rating Index[PRI]-Sensory), affective pain (PRI-Affective [0-14), evaluative pain (PRI-Evaluative), and pain pattern scores, adjusting for age, and comparing Black and Hispanic with White groups. Results: Gender was relatively balanced across the racial/ethnic groups (p=.54). There was significant difference among groups in mean age (p=.01; Black: 64.1±12.1, Hispanic: 66.5±16.6, White: 71.9±14.8). Baseline current and worst pain intensity were moderate and severe respectively across Black (4.7±2.9; 7.1±1.9), Hispanic (5.4±2.6; 7.7±2.1), and White (4.4±2.7; 6.7±2.6) groups (p&amp;gt;.05). Posttest current and worst pain intensity remained moderate and severe across Black (4.6±2.8; 6.5±2.3), Hispanic (4.7±2.4; 6.5±2.2) and White (4.0±2.4 and 5.9±2.4) groups (p&amp;gt;.05). Baseline values were not significantly different across racial/ethnic groups for PRI-Sensory, PRI-Evaluative, and pain pattern. Baseline PRI-Affective scores differed significantly among Black (1.8±2.0), Hispanic (3.8±3.9) and White (3.1±2.6) groups (p=.003). Higher baseline pain values for all variables except current pain were associated with younger age (p≤.02) and the Black group had significantly lower PRI-Affective (p=.001). Posttest, higher current pain and worst pain were associated with younger age (p=.04). Other pain variables were not associated with age or race/ethnicity (p&amp;gt;.05). Conclusions: Patients with advanced cancer, regardless of race or ethnicity, reported clinically important current and worst pain intensity suggesting the need for better pain control in the hospice setting. Younger patients reported more intense pain than older patients. Younger patients reported more intense pain than older patients. The significantly lower affective contribution to pain among Black patients at baseline represents a novel finding that warrants additional research. Insufficient pain control remained consistent across racial/ethnic groups in usual hospice care. The racial/ethnic disparities commonly observed in pain management was not evident in this sample. Citation Format: Jeronda C. Jenkins, Dottington Fullwood, Yingwei Yao, Diana Wilkie, Miriam O. Ezenwa. Exploring age and race/ethnic associations with the multiple dimensions of pain among cancer patients receiving home hospice care [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 A028.

Racial disparities in pancreatic cancer clinical trials: Defining the problem and identifying solutions.

Underrepresented minority patients with pancreatic cancer have differential access to cancer treatments, including clinical trials. The successful conduct and completion of clinical trials is critical to improve outcomes for patients with pancreatic cancer. Therefore, it is essential to consider how to maximize eligibility of patients for both therapeutic and non-therapeutic clinical trials. It is important for clinicians and for the health system to understand individual-, clinician-, and system-level barriers to recruitment, enrollment, and completion of clinical trials to alleviate bias. Understanding strategies that lead to improved enrollment of underrepresented minorities, socioeconomically disadvantaged individuals, and underserved communities will improve generalizability of cancer clinical trials and advance health equity.

Evaluation of an experiential training program in patient-centered outcomes and comparative effectiveness research for diverse researcher communities and health care organizations

The goal of the Patient-Centered Outcomes Research Partnership was to prepare health care professionals and researchers to conduct patient-centered outcomes and comparative effectiveness research (CER). Substantial evidence gaps, heterogeneous health care systems, and decision-making challenges in the USA underscore the need for evidence-based strategies. We engaged five community-based health care organizations that serve diverse and underrepresented patient populations from Hawai'i to Minnesota. Each partner nominated two in-house scholars to participate in the 2-year program. The program focused on seven competencies pertinent to patient-centered outcomes and CER. It combined in-person and experiential learning with asynchronous, online education, and created adaptive, pragmatic learning opportunities and a Summer Institute. Metrics included the Clinical Research Appraisal Inventory (CRAI), a tool designed to assess research self-efficacy and clinical research skills across 10 domains. We trained 31 scholars in 3 cohorts. Mean scores in nine domains of the CRAI improved; greater improvement was observed from the beginning to the midpoint than from the midpoint to conclusion of the program. Across all three cohorts, mean scores on 52 items (100%) increased (p ≤ 0.01), and 91% of scholars reported the program improved their skills moderately/significantly. Satisfaction with the program was high (91%). Investigators that conduct patient-centered outcomes and CER must know how to collaborate with regional health care systems to identify priorities; pose questions; design, conduct, and disseminate observational and experimental research; and transform knowledge into practical clinical applications. Training programs such as ours can facilitate such collaborations.

Abstract A090: Overcoming racial and ethnic disparities in cancer clinical trial accrual during the COVID-19 pandemic: A partnership between a cancer center’s clinical trials office and community outreach and engagement

Abstract Background: Despite passage of the NIH Revitalization Act in 1993, enrollment in clinical trials remains low for Black and Hispanic adults. The novel coronavirus 2019 (COVID-19) pandemic resulted in substantial disruptions to patient care, including challenges for clinical trial accrual. The extent to which the pandemic has disrupted clinical trial enrollment continues to be investigated; data on enrollment disruptions for different racial and ethnic groups are scarce. Objective: We compared racial and ethnic patient accrual to intervention cancer clinical trials before, and during the COVID-19 pandemic. Methods: We assessed monthly and annual enrollment to all intervention and treatment-intervention-only clinical trials coordinated by the Moores Cancer Center Clinical Trials Office (MCC CTO) from January 1, 2019 to December 31, 2021. We considered monthly enrollment from January 1, 2019 to March 31, 2020 to include the period before the onset of the COVID-19 pandemic and from April 1, 2020 to December 31, 2021 for the pandemic phase. We assessed the annual percentage of individuals enrolled in trials (i.e., 2019, 2020, and 2021) according to race (White, African American/Black, and Asian) and ethnicity (Hispanic, non-Hispanic). Results: Enrollment to all intervention clinical trials dropped from 512 patients in 2019 (pre-pandemic period) to 455 in 2020 and 447 in 2021, during the pandemic. Monthly accrual data show a drop in treatment intervention trials with the onset of the pandemic, from 36 in March 2020 to 25 in April 2020. This drop was followed by a quick rebound in May (n=42) and June (n=40), similar to the 2019 pre-pandemic figures (n=44 for May and 39 for June). Accrual dropped sharply with the second wave of the pandemic, from 34 in November 2020 to 17 in January 2021 but rebounded to 43 in May 2021. Annual enrollment by race shows that the percent of non-White cancer patients increased each year after the onset of the pandemic, from 23.5% in 2019 to 26.2% in 2020, and 31.3% in 2021 (p=0.06 comparing White to non-White patients for 2019 versus 2020 and 2021 combined). Similarly, the proportion of Hispanic patients on treatment trials increased from 21% in 2019, to 24% in 2020, and 27% in 2021 (p=0.34 comparing 2019 to 2020 and 2021 combined). Conclusion: Our results, from a single NCI designated comprehensive cancer center, show that although a drop-in accrual to interventional trials occurred from 2019 to 2020 and extended into 2021, accrual for non-White and Hispanic patients increased over this time period. We hypothesize that this was due to existing strategies that were in place as part of a MCC CTO-Community Outreach and Engagement partnership that provided institutional-, provider-, and patient-level support for accrual of under-represented patients. Furthermore, COVID-adaptive contingency measures to overcome challenges due to the pandemic were also implemented including pre-infusion COVID19 testing, remote interpreter services, and per protocol flexibility in minimizing in-person study visits. Citation Format: Jesse Nodora. Overcoming racial and ethnic disparities in cancer clinical trial accrual during the COVID-19 pandemic: A partnership between a cancer center’s clinical trials office and community outreach and engagement [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 A090.

Unintended Consequences? Medicare Commercial Partnerships Complicate Arthroplasty Care and Registry-Based Research: Commentary on an article by Jennifer C. Wang, BS, et al.: "The Rise of Medicare Advantage. Effects on Total Joint Arthroplasty Patient Care and Research".

Commentary The health-care environment has undergone major changes over the past 20 years, including the expansion of partnerships between commercial insurance carriers and the U.S. Department of Health and Human Services (HHS) through its subagency, the Centers for Medicare & Medicaid Services (CMS). Most orthopaedic surgeons performing arthroplasty procedures have probably observed the growing proportion of their patients with Medicare Advantage (commercially managed Medicare) plans. Few among us were likely aware of the full implication of this transition on clinical practice, patient outcomes, and the effectiveness of registry-based arthroplasty research. Wang and colleagues provide a thoughtful analysis of patient demographic characteristics, medical comorbidities, and 90-day postoperative adverse outcomes that were identified for 697,317 patients who underwent elective total hip or total knee arthroplasty in hospitals participating in the Premier Healthcare Database. The authors identified a 335% relative increase in patient participation in Medicare Advantage plans from 2004 to 2020, with increased enrollment of non-White patients, a propensity for increased Medicare Advantage enrollment in urban environments, and increased arthroplasty care engagement in teaching hospitals. While differences in medical comorbidities were not substantially different between patients enrolled in the 2 plan types, Medicare Advantage patients experienced an increased risk for stroke and acute kidney injury following surgery. The authors extrapolate their findings beyond the core data obtained to present their perspectives on the impact of CMS insurance privatization on the future of high-quality joint arthroplasty care. Increased administrative burdens, including pre-authorization coordination for appropriate and clinically indicated surgical treatment, have been encountered by most practicing surgeons and their support teams. The transition of quality reporting through qualified registries—including the American Joint Replacement Registry—has been built around traditional Medicare enrollment reporting mechanisms. At least 1 potentially unintended consequence of the transition toward Medicare Advantage plans is the shielding of patient-based procedural outcomes from these mechanisms—which may serve to undermine innovation and validation. There are some notable limitations of the study, which the authors have outlined. It is very challenging to use administrative databases to fully identify and investigate all factors that may influence adverse postoperative outcomes. While the database used by the authors identifies postoperative surgical and medical complications, it does not address the long-term performance of the implants and techniques. Moreover, the composite medical complexity of patients may not be fully represented in the analyzed data. The factors and conditions underlying patient decisions to select traditional Medicare or Medicare Advantage plans cannot be assessed, and the potential impact of selection bias on the study findings cannot be determined. The study highlights the unanticipated consequences that may arise when fiscally driven policy intersects with specialized medical care. Future studies will be valuable to determine whether the observations in this study are sustained as the growth of Medicare Advantage plans continues—especially with the trends suggesting that under-represented minority patients will potentially be the most adversely affected. With potential implications for arthroplasty care delivery and the future ability to utilize qualified registries to assess arthroplasty outcomes, it is crucial for advocacy efforts to guide policymakers toward ensuring the successful provision of arthroplasty care—including transparency of outcomes among patients who have elected to participate in Medicare Advantage programs.

Technical Dissonance in Home Blood Pressure Monitoring After Stroke: Having the Machine, but Not Using Correctly.

In individuals with hypertension (HTN), lowering blood pressure (BP) after a stroke can lower the risk of stroke recurrence, but many patients do not reach the goal. Home blood pressure monitoring (HBPM) can help patients get to the goal, but rates of use and quality of technique have not been evaluated. We conducted a cross-sectional study of patients with stroke. Patients were eligible if they had a stroke within 2 years, had HTN, and lived at home. We classified patients as correctly performing HBPM if they used an arm cuff, sat ≥ 1 min before measurement, took ≥ 2 measurements, and use within 6 months. The primary outcome was the proportion of patients who had an HBPM and used it correctly, which we calculated according to race and ethnicity. We also asked patients what they would do if they found results outside the goal. Among 150 participants, 120 (81%) possessed an HBPM and 29 (21%) used it correctly. We observed no significant disparity in rates of possession or correct use between non-Hispanic White participants and participants from underrepresented groups. Seventy percent of non-Hispanic White patients said they would contact their provider if their BP was above goal vs. 52% of underrepresented patients (P = 0.21). Most patients after stroke have an HBPM, but only about 1 in 5 use it correctly. Approximately half of the patients from underrepresented racial or ethnic groups do not have a plan for responding to the values above goal. Our results indicate opportunities to improve the dissemination and correct use of HBPM.

An audit of discharge medicines counselling on an acute elderly admissions unit

Abstract Introduction Poor discharge communication is a major contributor to medication-related errors during care transfers. The World Health Organisation 2019 Medication Safety report1 acknowledged this and recommended prioritising collaboration with patients/families/carers, communicating medication changes, and interdisciplinary working. The Care Quality Commission 2020 National Patient Inpatient Survey found that only 28% of participants received information regarding side-effects, 55% given explanations on medicines-use, 48% provided written information and 12% no information.2. Health information systems including Medicines a Patient Profile Summary (MaPPs) provide easy-read leaflets which may improve patient awareness and understanding of their medicines.3 This study explored patients’ experience of DMC at one hospital Trust. Aim To measure patient satisfaction and understanding of DMC offered at Mid Yorkshire Hospitals Trust and establish whether the Trust standards were met of all patients with medication changes (new/stopped/changed) receiving verbal DMC and being offered a MaPPs leaflets/charts documenting the changes. Method Ethics approval was not required for this service evaluation. Baseline data was collected from the Trust Medicines Information department to establish which ward had the most discharge enquiries in October 2021. Inpatients from this ward were included if they were elderly, had a previous admission within the last 2 months, usually lived at home and managed their own medications or had help from relatives/friends. Inpatients were excluded if they were care-homes residents, had carers who visited to administer medicines, used a compliance aid or had no medication changes. A 13-item questionnaire was designed for qualitative/quantitative data collection over a 4-week period in December 2021. Questions concerned discharge medicines information provided (written/verbal), patient/relative satisfaction and patient/relative understanding of medicines indicated and changes. Quantitative data underwent descriptive statistical analysis, whilst qualitative data were grouped by similarity and frequency counted. Results A total of 20 elderly patients/relatives were included: 11 were female and 9 were male. Eight respondents (40%) reported not receiving written information. Twelve respondents (60%) reported received a SystmOne discharge letter, of whom 7 received additional written information that included a discharge medication list. This was provided by nurses on all occasions. No respondents reported being offered a MaPPs leaflet/chart, but 17 respondents indicated that they thought that a MaPPs leaflets/chart would have been beneficial. Eleven respondents reported receiving verbal DMC, of whom 4 rated themselves as being “not very satisfied” with it. Key themes were: ‘rushed discharges’, ‘limited patient/relative involvement’. No respondents reported being informed about side-effects. Eleven and 14 respondents respectively reported partially/not fully understanding why medications were indicated or changes made. Discussion/Conclusion Overall, DMC was below the Trust standards. Poor explanation of changes and no information on side-effects was common practice. The findings are limited by the small sample size and limited generalisability to ethnic minorities. Future study plans include involving underrepresented patient groups in a larger sample. Nevertheless, the following recommendations were made: Offer all patients MaPPs leaflets/reminder charts and verbal DMC; Offer all elderly ward nurses pharmacy-led MaPPs training; add monthly reminders during morning handovers to use MaPPs; Document on the electronic prescribing system when MaPPs leaflets are provided.

Artist's Statement: Reach Back to Pull Forward.

I digitally painted Reach Back to Pull Forward, on the cover of this issue, to show the need for representation in medicine. The saying, “you are what you see,” stands especially true in this political climate. Being a Black physician can be isolating, so it is imperative that Black physicians build a ladder for those who come after us. In this work, I signified the traditional physician regalia through the black and forest green gown while maintaining the innocence of childhood, as represented by the school uniform. I put a beam of light in front of the two figures to represent progress, as they walk hand in hand to show togetherness.Reach Back to Pull ForwardI was inspired by the sense of community I felt when caring for a little Black girl who came into the emergency department—she had minor injuries from a motor vehicle crash. The girl was restless, and her mother said to her, “Listen to your aunty.” As a Black physician, I often have this kind of relationship with Black patients I have just met. This makes it possible for me to work with families who are resistant to care and have unguarded discussions about treatment, because they might trust me. I feel a personal responsibility to advocate for and amplify the voices of underrepresented patients I serve because of this feeling of community. I hope little Black boys and girls can see representation through the Black physician in my artwork, and know that there is a community of Black doctors who will nurture, mentor, and care for them—that it is possible for them to become doctors, too.

Patient Portal Perceptions in an Urban Community Health Center Setting: Insights for Telehealth

Introduction&#x0D; Patient portals are the “front door” to telehealth - online scheduling, video visit links, and digital after visit summaries are often conveyed via the patient portal. Patient portal tools often require similar patient skills and attitudes as telehealth adoption. Analyzing patients’ perceptions and beliefs around this digital patient engagement tool may lead to insights regarding telehealth, particularly in historically underrepresented patient populations.&#x0D; &#x0D; Methods&#x0D; Participants from a Federally Qualified Health Center (FQHC) in Chicago, IL were surveyed on general technology use, healthcare-specific technology use, and barriers and facilitators to patient portal use.&#x0D; &#x0D; Results&#x0D; The 149 respondents (81% response rate) represented a unique population base with 96% African American, 74% with educational attainment of some college or less, and 48% with at least one chronic medical condition. Technology access and use were high with 78% computer ownership, 98% mobile phone ownership (with 75% smartphone ownership). In terms of patient portal perception, 75% rated Perceived Usefulness (U) as high. Perceived Ease of Use (E) domains similarly had 70% or higher agreement from patients, and potential barriers and facilitators in the Attitudes Toward Use (A) section included a preference to calling their doctor, and minority of patients viewing the portal as unsafe way to communication, too complicated to use, or taking too much time. Additional stratification analysis by demographic variables (age, gender, educational attainment, and number of chronic conditions) revealed differences in portal perception across the Usefulness, Ease of Use, and Attitudes domains.&#x0D; &#x0D; Discussion&#x0D; Insights from barriers, attitudes, and capacity to use patient portal tools deliver important insight into overall adoption of other digital health modalities, including telehealth. In an urban historically underserved patient population, technology access and use is quite high, and mobile phones access was nearly ubiquitous with a large majority using the internet function on their mobile device. Different age groups, genders, levels of educational attainment, or degree of multi-morbidity have different values and needs. Therefore, each subpopulation needs targeted messaging of different portal benefits.&#x0D; &#x0D; Conclusion&#x0D; Our research provides initial insights into patient-level factors influencing patient portal attitudes, with implications toward telehealth adoption. Demographic differences have a significant impact on attitudes toward technology adoption. Equitable uptake of portal and telehealth services will require tailored messaging, training, and multiple modes of communication, including web-based and mobile.

Evaluating Anemia Related Morbidity in Premenopausal Female Minority and Disadvantaged Populations

Title: Evaluating anemia related morbidity in premenopausal female minority and disadvantaged populations Authors: Alexander Krule, M.D. M.S., Kristy Abraham, M.D., David Dulce, Sandra Cuellar Puri Pharm. D., Ameen Salahudeen, M.D. Ph.D., Amina Chaudhry, M.D. Introduction: In the United States, there are pronounced racial disparities in anemia prevalence among adult women under 50 years of age with 3.3% of white, 8.7% of Latina, and 24.4 % of Black women affected. The most common etiology of this anemia is iron deficiency anemia (IDA) affecting up to 12% of reproductive-aged American women across all racial groups with a disparate increased burden of IDA among Black women where 19% have iron deficiency. This presents an opportunity for multimodal interventions for patients and the medical community to improve health outcomes in women with iron deficiency anemia. The purpose of this study is to assess the severity and burden of iron deficiency anemia in the Black versus non-Black communities at University of Illinois (UI Health). Methods: We underwent a retrospective chart review of patients at UI Health with anemia from 1 June 2011 - 21 May 2021. Included patients were 18-40 years old, listed female sex in their charts, and had a diagnosis of iron deficiency anemia defined as serum hemoglobin less than 12 mg/dL and serum ferritin less than 30 ng/mL or transferrin saturation less than 19%. Exclusion criteria were male sex, amenorrhea, induced menopause, primary ovarian insufficiency, history of bariatric procedures circumventing the duodenum, autoimmune disease, and heart failure. In total, 951 patients with iron deficiency anemia were identified, of which 756 met criteria for analysis. We then grouped patients by listed race and ethnicity and stratified patients by severity of anemia as defined by the World Health Organization (WHO). WHO anemia severity grades anemia based on hemoglobin ranging from Grade 0 for hemoglobin values within reference range to Grade III and Grade IV for severe and life-threatening hemoglobin values below 7.9 and 6.5 g/dL, respectively. Statistical differences between groups were analyzed by ANOVA and logistic regression models. Results: Of the 756 patients included in the analysis, 68% identified as Black, 21% as Latinx, 12% as White, 5% as Asian, and 0.7% as American Indian/Alaskan Native. A one-way ANOVA revealed that there was a statistically significant difference in mean hemoglobin values between groups. Testing of the a priori hypotheses were conducted using Bonferroni adjusted alpha levels of .0125 (0.5/4) per test and showed a significantly lower mean serum hemoglobin for Black patients (M=9.7, SD=0.6) than non-Black patients (M=10.4, SD=0.4, F(4,1242)=14.8, p<10-11). In an unadjusted logistic regression model, Black race was significantly associated with more severe degree of anemia compared to non-Black race (OR=1.79, 95% CI [1.38,2.32]). Conclusion: More than two-thirds of female patients of reproductive age in the UI Health patient population with iron deficiency anemia self-report as Black. Black patients in this population have clinically significant lower hemoglobin levels than non-Black patients, and have a significantly increased hazard ratio for severe anemia. In our health system, symptomatic patients with severe and life-threatening anemia require emergent blood transfusion as standard of care, incurring further risk of morbidity and potentially mortality. Given the disparity we observe, and increased hazard for severe and potentially life-threatening anemia warrants further assessment into the delivery of healthcare to this underrepresented patient population. Evaluating what barriers may exist in delivering care to IDA patients in screening, diagnosis, and management of oral versus parenteral iron therapy should also be further studied. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Inadequate Use of Newer Treatments and Glycemic Control by Cardiovascular Risk and Sociodemographic Groups in US Adults with Diabetes in the NIH Precision Medicine Initiative All of Us Research Program

PurposeData are limited on sodium glucose co-transport 2 inhibitors (SGLT2-is) and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) among real-world cohorts of underrepresented patients. We examined these therapies and glycemic control in US adults with diabetes mellitus (DM) by atherosclerotic cardiovascular disease (ASCVD) risk and sociodemographic factors.MethodsIn the NIH Precision Medicine Initiative All of Us Research Program, we categorized DM as (1) moderate risk, (2) high risk, and (3) with ASCVD. We examined proportions on DM therapies, including SGLT2-i or GLP-1 RA, and at glycemic control by sociodemographic factors and CVD risk groups.ResultsOur 81,332 adults aged ≥ 18 years with DM across 340 US sites included 22.3% non-Hispanic Black, 17.2% Hispanic, and 1.8% Asian participants; 31.1%, 30.3%, and 38.6% were at moderate risk, high risk, or with ASCVD, respectively. Those with DM and ASCVD were most likely on SGLT2-i (8.6%) or GLP-1 RA (11.9%). SGLT2-i use was < 10% in those with heart failure or chronic kidney disease. The odds (95% CI) of SGLT2-i use were greater among men (1.35 [1.20, 1.53]) and Asian persons (2.31 [1.78, 2.96]), with GLP-1 RA being less common (0.78 [0.70, 0.86]) in men. GLP-1 RA use was greater among those with health insurance, and both GLP-1 RA and SGLT2-i greater within lower income groups. 72.0% of participants had HbA1c < 7%; Hispanic persons were least likely at glycemic control.ConclusionsTreatment with SGLT2-is and GLP-1 RAs remains low, even among higher ASCVD risk persons with DM and use is even lower among underserved groups.