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Background: To explore the association between ethnicity, as a proxy for language, and participation in clinical trials (CT) conducted by Principal Investigators (PI) who speak one or more language in addition to English. Methods: This retrospective, descriptive study utilized CT participant demographic data extracted from the largest Midwestern non-profit healthcare system between January 1, 2019 and 12/31/2021. The CT participant sample (N = 4308) was divided for comparison: CT Participants of Hispanic or Latino Origin (N = 254; 5.90 %) and CT Participants of Non-Hispanic or Latino Origin (N = 4054; 94.10 %). Logistic regressions were performed to generate the crude and adjusted odds of patients of Hispanic or Latino origin participating in CTs conducted by PIs who speak another language in addition to English. Results: Crude analysis revealed that patients of Hispanic or Latino ethnicity had 2.04 (1.58, 2.64) times greater odds of participating in CTs conducted by PIs who speak another language than English (

Objective To assess the association between pancreatic enzyme replacement therapy (PERT) and resource utilization among patients with chronic pancreatitis (CP) in a large Midwestern US healthcare system. Methods This retrospective cohort study used electronic medical record data. Eligible patients (N = 2445) were aged ≥18 years and diagnosed with non-cystic fibrosis CP between January 2005 and December 2018, with ≥6 months’ follow-up; study initiation was first encounter with the healthcare system. Patients in the PERT group were prescribed PERT at ≥1 encounter; patients in the non-PERT group were not prescribed PERT at any encounter. Results In total, 62,899 encounters were reviewed (PERT, n = 22,935; non-PERT, n = 39,964). More patients in the PERT group were younger, male, White, married/partnered and with private insurance than those in the non-PERT group. They also received longer care and had more overall encounters, fewer outpatient and day surgery/24-hour observation encounters, and more inpatient encounters. Emergency room encounters were similar between groups. Average cost by encounter was similar between groups ($225 and $213, respectively). Conclusions Despite similar average costs per encounter, the groups had very different encounter types. More inferential research on PERT use among patients with CP is needed, particularly regarding resource utilization and long-term outcomes.

Abstract Schizophrenia is often characterized by recurring relapses, which are associated with a substantial clinical and economic burden. Early identification of individuals at the highest risk for relapse in real-world treatment settings could help improve outcomes and reduce healthcare costs. Prior work has identified a few consistent predictors of relapse in schizophrenia, however, studies to date have been limited to insurance claims data or small patient populations. Thus, this study used a large sample of health systems electronic health record (EHR) data to analyze relationships between patient-level factors and relapse and model a set of factors that can be used to identify the increased prevalence of relapse, a severe and preventable reality of schizophrenia. This retrospective, observational cohort study utilized EHR data extracted from the largest Midwestern U.S. non-profit healthcare system to identify predictors of relapse. The study included patients with a diagnosis of schizophrenia (ICD-10 F20) or schizoaffective disorder (ICD-10 F25) who were treated within the system between October 15, 2016, and December 31, 2021, and received care for at least 12 months. A relapse episode was defined as an emergency room or inpatient encounter with a pre-determined behavioral health-related ICD code. Patients’ baseline characteristics, comorbidities and healthcare utilization were described. Modified log-Poisson regression (i.e. log Poisson regression with a robust variance estimation) analyses were utilized to estimate the prevalence of relapse across patient characteristics, comorbidities and healthcare utilization and to ultimately identify an adjusted model predicting relapse. Among the 8119 unique patients included in the study, 2478 (30.52%) experienced relapse and 5641 (69.48%) experienced no relapse. Patients were primarily male (54.72%), White Non-Hispanic or Latino (54.23%), with Medicare insurance (51.40%), and had baseline diagnoses of substance use (19.24%), overweight/obesity/weight gain (13.06%), extrapyramidal symptoms (48.00%), lipid metabolism disorder (30.66%), hypertension (26.85%), and diabetes (19.08%). Many differences in patient characteristics, baseline comorbidities, and utilization were revealed between patients who relapsed and patients who did not relapse. Through model building, the final adjusted model with all significant predictors of relapse included the following variables: insurance, age, race/ethnicity, substance use diagnosis, extrapyramidal symptoms, number of emergency room encounters, behavioral health inpatient encounters, prior relapses episodes, and long-acting injectable prescriptions written. Prevention of relapse is a priority in schizophrenia care. Challenges related to historical health record data have limited the knowledge of real-world predictors of relapse. This study offers a set of variables that could conceivably be used to construct algorithms or models to proactively monitor demographic, comorbidity, medication, and healthcare utilization parameters which place patients at risk for relapse and to modify approaches to care to avoid future relapse.

Background: Representativeness in clinical trials (CT) serves as a metric of access to healthcare and reflects differences that may determine differential efficacy of medical interventions; thus, quantifying representativeness in CT participation is critical. Methods: This retrospective, descriptive study utilized patient demographic data extracted from the largest Midwestern non-profit healthcare system. Using data between January 1, 2019 and December 31, 2021, a CT Participant Sample of 4,537 system patients who were active CT participants was compared to a CT Patient Population of 195,726 system patients receiving care by the PI of active CTs, which represented the target population. Chi-square goodness-of-fit tests were used to test differences in distributions of demographic variables between groups, indicating disparity in CT participation. Two metrics adapted from literature - participation incidence disparity (PID) and participation incidence ratio (PIR) - were calculated to quantify absolute and relative disparity in representativeness proportions, respectively. Descriptive approaches to assessing representativeness are also provided. Results: Results showed significant differences by race/ethnicity (χ2 = 50.64; p

Background: The lack of racial and ethnic diversity in clinical trials leads to skewed findings, limited generalizability, inequitable health outcomes for people of color, and insufficient access to innovative therapies. Our objective was to compare perceptions of barriers to participation in trials for people of color and trial staff to provide tangible solutions for improving diversity among study participants. Methods: This mixed method study utilized semi-structured interviews and surveys to evaluate barriers to participation and solutions to improve racial and ethnic diversity in clinical trials among healthcare system trial staff and community members from the same region. Through thematic analysis via coded transcripts and quantitative analysis via survey data, social support theory constructs were identified to evaluate where perceptions of barriers and solutions overlap and where they diverge. Results: A total of 55 trial staff and 75 community members participated in the study. Trial staff identified logistics and patients’ unwillingness to receive additional treatments as perceived barriers to participation, while community members stated lack of information and lack of trust in their care team. Both groups identified hesitance toward research as a prominent barrier. Solutions related to informational support demonstrated the most overlap between groups, while instrumental support showed the most discordance. Conclusion: Solutions for improving racial and ethnic diversity in clinical trial participation are multi-faceted and have various levels of impact. Overlap and discordance of opinions regarding solutions should be further evaluated, and implementation of solutions should be carefully considered.