Duration Of Enrollment Research Articles

The Healthcare Integrated Research Database (HIRD) as a Real-World Data Source for Pharmacoepidemiologic Research.

The Healthcare Integrated Research Database (HIRD) is a large, comprehensive real-world data (RWD) source for health-related research. Demographic and healthcare-related characteristics of individuals are sourced from routinely updated RWD. The HIRD includes health insurance claims and other health-related information for individuals enrolled in health insurance plans offered or managed by Elevance Health and has been utilized for research for almost two decades. Individuals in the HIRD reside throughout the United States. Data in the HIRD have been available since January 2006, and are updated monthly. As of July 2024, the researchable population of the HIRD included over 91 million individuals with medical benefits, and over 24 million individuals were actively enrolled. The median age of individuals in the HIRD is 36 years (interquartile range [IQR]: 22, 54), and 50% of individuals in the HIRD are female. The median duration of continuous enrollment in the HIRD is 2.0 years (IQR: 0.8, 4.7). For those actively enrolled, the median duration of continuous enrollment is 3.8 years (IQR: 1.7, 8.3). Other important characteristics of the HIRD include the ability to trace data back to their source, support both deterministic and probabilistic linkage with external data sources, and link family members within health plans. The HIRD has been a trusted resource to generate real-world evidence for a variety of health-related research, including regulatory-required safety studies, comparative effectiveness studies, and health economics and outcomes research.

Heterogeneity across outcomes in clinical trials on sodium-glucose cotransporter 2 (SGLT2) inhibitors in chronic heart failure: cross-sectional study.

This study aimed to analyze the outcomes, outcome domains, and prevalence of the use of clinical outcome endpoints (COE) in clinical trials on sodium-glucose cotransporter 2 (SGLT2) inhibitors for chronic heart failure (CHF) registered on ClinicalTrials.gov and compare them to COE for cardiovascular trials. We conducted a cross-sectional methodological study. Trials and trial outcomes were extracted from ClinicalTrials.gov, classified, and analyzed. For pivotal trials, registrations were compared with matching publications and supplementary documentation. The adherence of outcomes in pivotal clinical trials to COE developed by the European Society of Cardiology (ESC) was checked. In 71 included trials we found 170 individual clinical outcomes and divided them into 11 groups (10 clinical outcome groups, and ESC COE). Heart failure with reduced ejection fraction (HFrEF) was analyzed in 33 (46%) trials, and heart failure with preserved ejection fraction (HFpEF) in 25% of trials. ESC COE outcomes were used in less than 30% of trials, and only in 9 as primary outcomes (13%). Trials included 59 different biomarker endpoints. Patient-reported outcomes were highly heterogeneous, utilizing various non-validated questionnaires. All five pivotal trials used primary outcomes from ESC COE. The adherence of pivotal trials to the ESC COE was moderately high, with insufficient data on dyspnea and heart failure events such as intensification of diuretic therapy. All pivotal trials had at least one change in study protocol at one point during the trial, in outcome measures, statistical model, enrollment, or trial duration. Outcomes used in CHF trials of SGLT2 inhibitors were highly heterogeneous. Core outcome sets developed especially for CHF were underutilized. Standardization of outcomes is needed in the CHF field to enable between-trial comparisons and evidence syntheses.

Impact of TCF7L2 rs7903146 on clinical presentation and risk of complications in patients with type 2 diabetes.

TCF7L2 rs7903146 is the most impactful single genetic risk variant for type 2 diabetes. However, its role on disease progression, complications and mortality among people with type 2 diabetes at diagnosis remains unclear. We assessed the per allele impact of the rs7903146 T-allele on clinical characteristics and complication risk in 9231 individuals with type 2 diabetes at diagnosis and over a 10-year follow-up period. Log-binomial and robust Poisson regression analyses were used to estimate prevalence ratios for clinical characteristics and macro- and microvascular complications at diabetes onset, while Cox regression was applied to estimate the risk of complications post-diagnosis. Analyses were adjusted for sex, calendar year at birth, age at enrollment and diabetes duration. The per T-allele impact was associated with 0.6 kg/m2 (95% CI: 0.4, 0.8) lower BMI, 1.4 cm (95% CI: 1.0, 1.8) smaller waist circumference, 5.6% (95% CI: 4.2, 7.0) lower insulin secretion and 5.0% (95% CI: 3.3, 6.7) higher insulin sensitivity. Over 10 years, the per T-allele impact was associated with lower risks for major adverse cardiovascular events (0.87 [95% CI 0.79, 0.95]), myocardial infarction (0.82 [95% CI: 0.72, 0.93]) and heart failure (0.85 [95% CI 0.73, 1.00]), with no significant impact on microvascular complications. The TCF7L2 variant is associated with less obesity, lower insulin secretion and higher insulin action at diabetes onset, and decreased risk of cardiovascular events following type 2 diabetes onset.

Examining duration of family enrollment in subsidized child care after policy change: Disaggregated outcomes for diverse populations in New Mexico

Examining duration of family enrollment in subsidized child care after policy change: Disaggregated outcomes for diverse populations in New Mexico

Out of Pocket Expenditure Among Patients Covered Under Voluntary Health Insurance for Kidney Replacement Therapy in a Tertiary Care Teaching Hospital in Coastal Karnataka

Background Chronic kidney disease (CKD) is a global health concern and is associated with high cost of care. This study aims to evaluate the out-of-pocket expenditure (OPE) among CKD patients covered by voluntary health insurance (VHI) for kidney replacement therapy (KRT) services and assess their knowledge and satisfaction with existing coverage. Materials and Methods Data were collected from 68 patients covered by 14 VHI schemes. Sociodemographic characteristics, morbidity details, and health insurance specifics were analyzed using SPSS software. Statistical tests, including Chi-square and Mann-Whitney U, were used to assess associations and median satisfaction scores. Results Significant differences were found between government and private health insurance companies regarding morbidity (X2=8.094, p=0.004) and annual family income (X2=5.057, p=0.03). Statistically significant variations (p < 0.001) were also observed in policy type, beneficiary type, annual premiums, coverage amounts, enrollment duration, and frequency of hospital admissions. OPE showed no significant difference. Satisfaction scores for reimbursement and affordability were high but not statistically significant. Many participants lacked awareness about aspects of their health insurance policy, regardless of the provider. Conclusion Despite VHI coverage, CKD patients undergoing KRT experience substantial financial burden. Improved patient education and policy transparency are essential to address gaps in coverage and alleviate financial strain. These findings underscore the need for policy reforms and patient-centered interventions to enhance healthcare access and affordability for CKD patients in India.

Incidence and Prevalence of Atherosclerotic Cardiovascular Disease in Cutaneous Lupus Erythematosus

Autoimmune diseases such as systemic lupus erythematosus (SLE) and psoriasis have been previously associated with an increased risk of atherosclerotic cardiovascular disease (ASCVD). Whether similar increased ASCVD risk is seen with cutaneous lupus erythematosus (CLE) remains unclear. To evaluate the incidence and prevalence of ASCVD among those with CLE, SLE, and psoriasis compared with a disease-free control group. This retrospective, matched longitudinal cohort study used data from January 2018 to December 2020 in the IBM MarketScan Commercial Claims and Encounters Database. The control population included individuals free of CLE, SLE, and psoriasis, matched 10:1 with the CLE population on age, sex, insurance type, and enrollment duration. Data were analyzed from September 2022 to April 2024. Prevalent ASCVD was defined as coronary artery disease, prior myocardial infarction, or cerebrovascular accident. Incident ASCVD was assessed through the number of hospitalization events through the end of follow-up (up to 3 years) in each group. Multivariable logistic regression and Cox proportional hazards models were performed to compare the prevalence and incidence of ASCVD between exposure groups, adjusting for age, sex, and cardiovascular risk factors. A total of 8138 persons with CLE (median [IQR] age, 49 [40-47] years; 6618 [81%] female), 24 675 with SLE (median [IQR] age, 46 [36-54] years; 22 432 [91%] female), 192 577 persons with psoriasis (median [IQR] age, 48 [36-56] years; 106 631 [55%] female), and 81 380 control individuals (49 [40-57] years; 66 180 [81%] female) were identified. In multivariable analysis, the odds of ASCVD were higher than control for CLE (odds ratio [OR], 1.72 [95% CI, 1.45-2.02]; P < .001) and SLE (OR, 2.41 [95% CI, 2.14-2.70]; P < .001), but not psoriasis (OR, 1.03 [95% CI, 0.95-1.11]; P = .48). At median 3 years follow-up, incidence rates of ASCVD were highest for SLE (24.8 [95% CI, 23.3-26.4] per 1000 person-years), followed by CLE (15.2 [95% CI, 13.1-17.7] per 1000 person-years), psoriasis (14.0 [95% CI, 13.5-14.4] per 1000 person-years), and then controls (10.3 [95% CI, 9.77-10.94] per 1000 person-years). In multivariable Cox proportional regression modeling with the control group as a reference group, the highest risk of incident ASCVD was in those with SLE (hazard ratio [HR], 2.23 [95% CI, 2.05-2.43]; P < .001), followed by CLE (HR, 1.32 [95% CI, 1.13-1.55]; P < .001), and psoriasis (HR, 1.06 [95% CI, 0.99-1.13]; P = .09). In this retrospective matched longitudinal cohort study, CLE was associated with an increased risk for ASCVD, similar to the risk in SLE but higher than the risk in psoriasis. The role of comorbidities that augment ASCVD risk like smoking status should be further investigated. Clinicians treating patients with CLE can consider them at increased ASCVD risk and institute appropriate screening tests.

Evaluating the burden of illness of metabolic dysfunction-associated steatohepatitis in a large managed care population: The ETHEREAL Study.

Metabolic dysfunction-associated steatohepatitis (MASH; formerly nonalcoholic steatohepatitis) is the inflammatory form of metabolic dysfunction-associated steatotic liver disease (formerly nonalcoholic fatty liver disease). MASH is a progressive disease associated with increased risk for many hepatic and extra-hepatic complications such as cirrhosis, hepatocellular carcinoma, the requirement for liver transplantation, and cardiovascular (CV)-related and kidney-related complications. It is important to understand the clinical and economic burden of MASH. To assess and compare the clinical and economic burdens of MASH in adults with the non-MASH population in a real-world setting. This observational, retrospective study used the Healthcare Integrated Research Database (HIRD), which contains health care claims data for commercially insured and Medicare Advantage health plan members across the United States. All-cause, CV-related, and liver-related medical costs and health care resource utilization were evaluated in patients with at least 2 diagnoses of MASH during the patient identification period (October 1, 2016, to April 30, 2022) and compared with a non-MASH cohort 1:1 matched on age, Quan Charlson Comorbidity Index, region of residence, and health plan type and length of enrollment. Generalized linear regression with negative binomial and γ distribution models were used to compare health care resource utilization and medical costs, respectively, while controlling for confounders. Covariate-adjusted all-cause, CV-related, and liver-related hospitalization rate ratios and medical cost ratios were assessed and compared for the MASH and matched non-MASH cohorts. A total of 18,549 patients with MASH were compared with 18,549 matched patients in the non-MASH cohort. After adjusting for covariates, MASH was associated with significantly higher rates of hospitalization and higher medical costs compared with the non-MASH cohort. When compared with the non-MASH cohort, patients with MASH had 1.22 (95% CI = 1.15-1.30; P < 0.0001) times higher rates of all-cause hospitalization, 1.13 (95% CI = 1.03-1.24; P = 0.008) times higher rates of CV-related hospitalization, and 7.22 (95% CI = 4.91-10.61; P < 0.0001) times higher rates of liver-related hospitalization. Similarly, all-cause medical costs were 1.26 (95% CI = 1.22-1.30; P < 0.0001) times higher, CV-related medical costs were 1.66 (95% CI = 1.59-1.73; P < 0.0001) times higher, and liver-related medical costs were 7.79 (95% CI = 7.42-8.17; P < 0.0001) times higher among patients with MASH. Compared with those of the non-MASH cohort with similar age, Quan Charlson Comorbidity Index, health plan, region of residence, and duration of enrollment, patients with MASH had significantly higher all-cause, CV-related, and liver-related hospitalizations and medical costs.

Automated digital counselling promotes therapeutic change in mental health in patients with chronic heart failure or chronic kidney disease: ODYSSEE-vCHAT study

Abstract Background The efficacy of digital programs to improve the management of chronic heart failure (CHF) and chronic kidney disease (CKD) is not established. Building on related studies in digital health, behavioural counselling, and social support, we evaluated whether an automated digital counselling program with social network support (ODYSSEE-vCHAT) could improve mental health and health-related quality of life in patients with CHF or CKD. Purpose The primary objective was to examine whether engagement with ODYSSEE-vCHAT was associated with a minimal clinically important difference for improvement in the Mental Component Summary (MCS) of the SF-36 at end-of-study. Secondary outcomes included: ENRICHD Social Support Index (ESSI), Patient Health Questionnaire for Depression (PHQ-9) Godin-Shephard Leisure Time Physical Activity Scale (GSLTPAQ), and an index of the frequency to which patients engaged in goal-directed activities for living well (EUROIA). Methods ODYSSEE-vCHAT was a multi-centre, single group, open label study with assessments at baseline and end-of-study (approximately 11 months). Inclusion criteria were: ≥18 years of age, diagnosis of CHF (reduced ejection fraction (EF) ≤ 40%, mid-range EF, 41-49%, or preserved EF ≥ 50%); or CKD diagnosis (&amp;gt;10% risk for dialysis using the 4-variable, 2-year Kidney Failure Risk Equation, or on dialysis). Exclusion was based on inability to participate due to co-morbidities. The digital counselling protocol taught self-care skills to improve mental health, quality of life, and adherence to medications, exercise, diet, and smoke-free living (Figure 1). Patient engagement with ODYSSEE-vCHAT was defined as Not Engaged (0 logon minutes) vs. Engaged (&amp;gt; 0 logon minutes). The primary outcome was a minimal clinically important difference for MCS change: ΔMCS ≥ 3.8 or MCS ≥ 65 at baseline and study endpoint. It was assessed using multivariable binary logistic regression, controlling for exposure to COVID-19 and health literacy. Secondary outcomes were assessed using multivariable linear regression analyses with the same covariates. Results 215 patients were enrolled. There were 7 deaths and 34 withdrew. In our sample of 174 patients, mean age = 54.4 years (95% Confidence Interval, CI, 25, 81), gender identity as women, n = 68 (39%), ethno-racial group other than White, n = 83, (48%), primary diagnosis, CHF, n = 68 (39%), and CKD, n = 106 (61%). Duration of enrolment to end-of-study: median = 352 days, (95% CI, 159, 496). Engagement with ODYSSEE was associated with therapeutic change on the MCS (for both CHF and CKD patients, and CHF patients alone), GSLTPAQ, and EUROIA, but not the PHQ9 or ESSI (Figure 2). Conclusions Automated digital counselling with social network support promotes improvement in indices of mental health for patients with CHF and CKD. These findings support a follow-up randomized controlled trial.Figure 1.ODYSSEE-vCHAT Study ProtocolFiFigure 2.ODYSSEE-vCHAT Study Outcomes

Automated digital counselling with social network support for chronic heart failure fails to improve health status but promotes health-related quality of life: ODYSSEE-vCHAT pilot trial

Abstract Background Automated digital counselling programs have the potential to provide a scalable, complementary behavioural intervention to improve clinical outcomes for chronic heart failure (CHF). Purpose The primary hypothesis for this pilot trial was that automated digital counseling with social network support (ODYSSEE-vCHAT) vs. Usual Care would decrease the incidence of all-cause re-hospitalization or ED visits. Secondary outcomes included: minimal clinically important difference for improvement on the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS), and improvement on ENRICHD Social Support Index (ESSI), Patient Health Questionnaire for Depression (PHQ-9) Godin-Shephard Leisure Time Physical Activity Scale (GSLTPAQ), and Self-Efficacy in Managing Chronic Disease (SEMCD6). Methods This 2-arm, parallel group, single-blind pilot trial randomized patients to ODYSSEE-vCHAT vs. Usual Care. Patients were ≥18 years of age with CHF (reduced ejection fraction [HFrEF] &amp;lt; 40%, mid-range [HFmrEF] 40-49%, or preserved [HFpEF] ≥ 50%). Exclusion was based on inability to participate due to co-morbidities. All-cause hospitalization or ED visit were assessed digitally by hospital administrative data. Questionnaires were administered at baseline and end-of-study (approximately 8 months). The digital counselling protocol aimed to improve CHF self-care, HRQL, and adherence to medications, exercise, diet, and smoke-free living (Figure 1). The primary outcome was assessed using multivariable binary logistic regression. Secondary outcomes were assessed using multivariable linear regression analyses with ethno-racial group as a covariate. Results 61 patients were randomized: ODYSSEE-vCHAT, n = 30 (49%), vs. Usual Care, n = 31 (51%). There were 2 deaths, 3 withdrawals, and 12 patients failed to complete secondary outcome assessments. Sample characteristics included mean age = 59 years (95% Confidence Interval, CI, 30, 76), gender identity as women, n = 23 (38%), ethno-racial group other than White, n = 17, (28%) and CHF with HFrEF, n = 47 (77%), HFmrEF, n = 8 (13%), and HFpEF, n = 4 (7%). Duration of enrollment to trial endpoint: mean = 247 days, (95% CI, 75, 382). Figure 2 indicates that ODYSSEE-vCHAT was not associated with lower incidence of all-cause hospitalization/ED visit: composite index events for Usual Care, n = 8 (28%), ODYSSEE-vCHAT, n = 7 (23%). However, ODYSSEE-vCHAT was associated with greater prevalence of KCCQ-OS change (≥ 5 points), and greater improvement in self-efficacy (SEMCD6) for managing CHF. There was a statistical trend to decreased prevalence of depression. Social support was inversely associated with ODYSSEE-vCHAT. No benefit was observed for physical activity (Figure 2). Conclusions Automated digital counselling with social network support promotes improvement in HRQL indices, but not health status. Findings for this pilot trial support a follow-up phase 2 randomized controlled trial.Digital Counselling ProtocolODYSSEE-vCHAT Outcomes

Using non-inferiority test of proportions in design of randomized non-inferiority trials with time-to-event endpoint with a focus on low-event-rate setting.

For cancers with low incidence, low event rates, and a time-to-event endpoint, a randomized non-inferiority trial designed based on the logrank test can require a large sample size with significantly prolonged enrollment duration, making such a non-inferiority trial not feasible. This article evaluates a design based on a non-inferiority test of proportions, compares its required sample size to the non-inferiority logrank test, assesses whether there are scenarios for which a non-inferiority test of proportions can be more efficient, and provides guidelines in usage of a non-inferiority test of proportions. This article describes the sample size calculation for a randomized non-inferiority trial based on a non-inferiority logrank test or a non-inferiority test of proportions. The sample size required by the two design methods are compared for a wide range of scenarios, varying the underlying Weibull survival functions, the non-inferiority margin, and loss to follow-up rate. Our results showed that there are scenarios for which the non-inferiority test of proportions can have significantly reduced sample size. Specifically, the non-inferiority test of proportions can be considered for cancers with more than 80% long-term survival rate. We provide guidance in choice of this design approach based on parameters of the Weibull survival functions, the non-inferiority margin, and loss to follow-up rate. For cancers with low incidence and low event rates, a non-inferiority trial based on the logrank test is not feasible due to its large required sample size and prolonged enrollment duration. The use of a non-inferiority test of proportions can make a randomized non-inferiority Phase III trial feasible.

The Association between Medroxyprogesterone Acetate Exposure and Meningioma

Background/Objectives: Medroxyprogesterone acetate (MPA) is a synthetic progesterone that is most commonly used as a contraceptive. MPA acts by binding to the progesterone receptor of the hypothalamus, and this receptor has been found to be important in the pathophysiology of meningiomas. Recent research has reported an increased association between the use of MPA and intracranial meningioma, though the literature is mostly limited by low numbers of meningioma cases and low exposure to MPA. The objective of the current study is to build upon the previously published literature utilizing a large database from the United States. Methods: Utilizing a large commercial insurance database, the current matched case–control study identified meningioma cases using ICD-10 codes from hospital data and MPA exposure, as established from pharmaceutical claims data. Controls were matched 10:1 to cases based on age, year of enrollment, and duration of enrollment. A conditional logistic regression estimated odds ratios (ORs) for the association between MPA exposure and the odds of developing a meningioma. Results: Among 117,503 meningioma cases and 1,072,907 matched controls, oral MPA exposure was not associated with odds of meningioma; however, injection MPA exposure was associated with a 53% increased odds of being a case (OR 1.53, 95% CI 1.40–1.67). This association was specific to cerebral meningiomas (OR 1.68, 95% CI 1.50–1.87), an association that became stronger with a longer duration of use of injection MPA. Conclusions: The current results are consistent with the prior literature, which reports an association between injection exposures to MPA and a stronger association with increasing use of MPA. Women should be cautioned about the prolonged use of MPA, and future research should examine whether the extended use of MPA is associated with the meningioma grade.

Clinical manifestations, healthcare resource utilization, and costs among patients with long-chain fatty acid oxidation disorders: a retrospective claims database analysis

Objective Long-chain fatty acid oxidation disorders (LC-FAOD) are a group of rare genetic inborn errors of metabolism. Clinical manifestations may result in frequent healthcare visits, hospitalizations, and early death. This retrospective cohort study assessed manifestations, healthcare resource use (HRU), direct medical costs, and the impact of COVID-19 on HRU among patients with LC-FAOD. Methods The IQVIA PharMetrics Plus database was searched for pediatric (0–17 years) and adult (≥18 years) patients with confirmed LC-FAOD (ICD-10-CM Diagnosis Code E71.310) and ≥12 months continuous enrollment (CE) between January 2016-February 2020. A non–LC-FAOD general population cohort was randomly selected and matched using 1:20 exact matching on age, gender, payer type, and CE start year. Manifestations were identified via ICD-10 diagnosis codes (any billing position). Overall HRU and attributable costs were stratified by care setting. Pre-COVID-19 (March 2019–February 2020) and during COVID-19 (March 2020-February 2021) HRU was assessed among a subgroup of patients and the general population. Outcomes were evaluated among children and adults, respectively. Results 423 patients with LC-FAOD (47% female; 79.7% children) were included. The mean enrollment duration was 2.6 ± 1.2 years. 22.6% of children with LC-FAOD had at least one major clinical event (MCE), consisting of rhabdomyolysis (10.1%), hypoglycemia (9.8%), or cardiomyopathy (8.6%) versus 1.5% overall occurrence in the general population. Adults with LC-FAOD had a higher incidence of MCEs (37.2%) than children with LC-FAOD. Annualized all-cause HRU in all care settings and mean total annualized medical costs (children: $17,082 vs $4144; adults: $43,602 vs $3949) were higher in patients with LC-FAOD versus the general population. Patients with LC-FAOD had substantially fewer healthcare visits during COVID-19 across care settings than during the pre-COVID-19 period. Conclusions LC-FAOD impart a high burden on patients. Extended hospital stays and increased outpatient management were especially pronounced for adults and for patients with ≥1 MCE, resulting in substantially higher medical costs than the general population.

Advance Care Planning in Nursing Homes: Comparing Characteristics and Outcomes of Participants and Non-Participants

Background There is an increasing need to integrate Advance Care Planning (ACP) in nursing homes (NH) due to rapid aging and burden of multimorbidity. This study examines differences in the characteristics and outcomes of NH residents enrolled in a palliative care programme who have completed ACP and those who did not. Method We conducted a retrospective cohort analysis of 294 deceased residents enrolled into a palliative programme from 8 nursing homes in Singapore. Comparison was made between residents who completed an ACP and those who did not. Treatment preferences and place of death preferences were examined and concordance to these preferences were analyzed. Results ACP completion rate was 81% in the cohort. Residents opting for comfort measures only had high concordance (92%) for their preferred place of death (PPOD). However, residents opting for limited intervention showed lower PPOD concordance (77%), with many dying in hospitals despite a preference for dying in the NH. Residents with ACP were significantly more likely to die in NH (68.2% vs. 36.4%) and had a longer median programme enrolment duration (131 vs. 53 days) compared to those who did not complete ACP. Conclusion Despite high ACP completion rate in our cohort, challenges remain in aligning treatment preferences with actual care provided, particularly for residents opting for limited intervention. Future efforts should focus on increasing ACP participation and addressing systemic barriers to improve end-of-life care outcomes for NH residents.

The effect of histopathologic analysis and tissue cultures on inpatient management of cellulitis: a randomized control trial

Background: In the absence of a gold-standard diagnostic modality for cellulitis, sterile inflammatory disorders may be misdiagnosed as cellulitis. Objective: To determine the utility of skin biopsy and tissue culture for the diagnosis and management of patients admitted with a diagnosis of presumed cellulitis. Design: Pilot single-blind parallel group randomized controlled clinical trial in 56 patients with a primary diagnosis of presumed cellulitis. In the intervention group only, skin biopsy and tissue culture results were made available to the primary care team to guide diagnosis and management. Length of hospital stay and antibiotic use were evaluated as outcome measures. Results: Length of stay showed the greatest opportunity for further study as a primary outcome (intervention: 4, IQR (2–6) vs. control: 5 IQR (3–8) days; p = 0.124). Limitations: The COVID-19 pandemic placed limitations on participant enrollment and study duration; in addition, data was collected from a single medical center. Conclusion: This study demonstrates that length of stay and anti-pseudomonal antibiotic de-escalation are endpoints that may be influenced by biopsy and tissue culture results in presumed cellulitis patients; these outcomes warrant further study.

Loss of Medicaid Coverage During the Renewal Process

Medicaid beneficiaries must periodically redemonstrate their eligibility in a process that is called renewal, redetermination, or recertification. The number and characteristics of people who lose Medicaid coverage due to renewal requirements are not known. To measure the proportion of people who lose Medicaid coverage at the renewal deadline, overall and by enrollee characteristics, and time until regaining Medicaid coverage among those losing coverage at the deadline. This cohort study tracked the duration of Medicaid enrollment among Wisconsin Medicaid enrollees with a 12-month renewal deadline. Data were collected for all nonelderly (aged <65 years) new enrollees from January 2016 through January 2018, except those enrolled due to disability or pregnancy. Individuals were followed through January 2020 to provide at least 24 months of data on each enrollment spell. Data were analyzed from August 2023 to February 2024. The primary outcome was coverage loss during the renewal process, defined as a loss in Medicaid coverage from month 12 to month 13 for people who were still enrolled at the start of month 12. Secondary outcomes included coverage loss prior to the renewal deadline and the duration of the gap in Medicaid coverage among those who lost coverage during the renewal process. The study sample included 684 245 Medicaid enrollment spells across 586 044 people (51% female and 47% children 18 years or younger). Among enrollees, 20% lost Medicaid coverage at the renewal deadline. Of those who lost coverage, 37% regained Medicaid coverage within 6 months, and an additional 10% regained coverage within 12 months. Children younger than 12 years and people with more Medicaid-covered health care (top quartile of Medicaid-covered health care costs during the first 6 months of enrollment) were less likely than other groups to lose coverage during the renewal process (15% and 6% lost coverage at renewal, respectively) and more likely to regain Medicaid quickly. Personal characteristics such as gender and race and ethnicity remained associated with the risk of losing Medicaid at the renewal deadline after adjustment for baseline household income, enrollment group, and past use of Medicaid services. In this cohort study, the risk of coverage loss during the Medicaid renewal process was associated with age, past use of care, and other personal characteristics. These findings shed light on how renewal requirements shape access to Medicaid.

Racial and Ethnic Disparities in Initiation of Direct Oral Anticoagulants Among Medicare Beneficiaries

The influence of race and ethnicity on initiation of direct oral anticoagulants (DOACs) is relatively understudied in Medicare data. To investigate disparities in the initiation of DOACs compared with warfarin by race, ethnicity, and social vulnerability. This retrospective cohort study used a 50% sample of Medicare fee-for-service data from January 1, 2010, to December 31, 2019 (mean patient enrollment duration, 7.7 years). Analysis took place between January 2023 and February 2024. A cohort of older adults (aged ≥65 years) with atrial fibrillation who newly initiated warfarin or DOACs (dabigatran, rivaroxaban, apixaban, and edoxaban) was identified. Patients were classified as non-Hispanic White, non-Hispanic Black, and Hispanic. The likelihood of starting use of DOACs compared with warfarin was modeled, adjusting for race, ethnicity, age, sex, county-level social vulnerability, and other clinical factors. Among 950 698 anticoagulation initiations, consisting of 680 974 DOAC users and 269 724 warfarin users (mean [SD] age, 78.5 [7.6] years; 52.6% female), 5.2% were Black, 4.3% were Hispanic, and 86.7% were White. During the 10-year study period, DOAC use increased for all demographic groups. After adjustment, compared with White patients, Black patients were 23% less likely (adjusted odds ratio [AOR, 0.77; 95% CI, 0.75-0.79) and Hispanic patients were 13% less likely (AOR, 0.87; 95% CI, 0.85-0.89) to initiate DOAC use. Disparities in DOAC initiation were greatest among Black patients in the earlier years but attenuated during the study period. For instance, in 2010, the OR of Black patients initiating DOACs was 0.54 (95% CI, 0.50-0.57), attenuating linearly over time to 0.69 by 2013 (95% CI, 0.65-0.74) and 0.83 (95% CI, 0.78-0.89) by 2017. By 2019, these differences became nonsignificant (OR, 1.08; 95% CI, 0.99-1.18). In this cohort study of Medicare patients with atrial fibrillation, Black and Hispanic patients were less likely to initiate DOACs for atrial fibrillation, although these differences diminished over time. Identifying the factors behind these early disparities is crucial for ensuring equitable access to novel therapies as they emerge for Black and Hispanic populations.

The effect of differences in trial design on estimates of efficacy of olanzapine in randomized studies

BackgroundDifferences in trial design may affect estimates of efficacy of psychotropic drugs. The purpose of this meta-analysis is to evaluate whether the use of Olanzapine (OLZ) as either investigational or control drug affects the observed efficacy of OLZ. MethodsWe performed a search for Randomized-Controlled Trials (RCTs) in which the efficacy of OLZ is assessed in patients with schizophrenia or schizoaffective disorder. We assessed overall efficacy of OLZ and performed subgroup analyses of studies with OLZ as intervention or comparator. Mixed-effect meta-regression analyses were performed. ResultsOf the 25 RCTs included, OLZ was considered as investigational drug or active control in 13 and 12 studies, respectively. The reduction of PANSS score was greater in trials in which OLZ was used as investigational drug. Multivariate meta-regression models showed that a higher PANSS score at baseline and trial duration were the main predictors of greater PANSS score reduction. ConclusionsTrials with OLZ used as investigational drug differ from those of trials with OLZ as comparator for baseline PANSS scores and study duration; these differences may produce differences in estimates of efficacy. As a consequence, the severity of illness at enrollment and trial duration should be carefully considered to ensure the reliability of indirect comparisons among antipsychotics.

Abstract SY15-02: Health insurance and outcome disparities in adolescents and young adults with cancer

Abstract SY15-02: Health insurance and outcome disparities in adolescents and young adults with cancer

A Phase II Study of Rucaparib Monotherapy in Nonmetastatic, Hormone-Sensitive Prostate Cancer Demonstrating "BRCAness" Genotype (ROAR).

Both germline and somatic BReast CAncer gene (BRCA) mutations are poor prognostic markers in men with localized or metastatic prostate cancer. For instance, men with these mutations often are diagnosed with prostate cancer earlier and develop metastatic disease earlier compared with those who do not harbor similar mutations. Patients with germline alterations typically have more advanced disease and shorter overall survival (Castro E, Goh C, Olmos D, et al. Germline BRCA mutations are associated with higher risk of nodal involvement, distant metastasis, and poor survival outcomes in prostate cancer. J Clin Oncol. 2013;31(14):1748-1757. doi:10.1200/JCO.2012.43.1882). The risk of disease progression to metastatic disease is significant in patients with this genotype of prostate cancer. The percentage of patients free from metastatic disease was 90%, 72%, and 50%, respectively, compared with 97%, 94%, and 84% at 3, 5, and 10 years for patients with intact DNA repair (P < .001) (Castro E, Goh C, Leongamornlert D, et al. Effect of BRCA mutations on metastatic relapse and cause-specific survival after radical treatment for localised prostate cancer. Eur Urol. 2015;68(2):186-193. doi: 10.1016/j.eururo.2014.10.022). DNA damage repair non-BRCA mutations include alterations in genes such as ATM, CHEK2, PALB2, and RAD51. While less common than BRCA mutations, they have emerged as significant prognostic markers in prostate cancer. These BRCAness mutations are associated with a higher risk of aggressive disease and poorer survival outcomes. Given the debilitating physical and psychological side effects of androgen deprivation therapy (ADT) in relatively younger men with prostate cancer, delaying ADT in these men may be an attractive strategy. Given the proven efficacy of polyadenosine diphosphate-ribose polymerase (PARP) inhibitors in the castration-resistant prostate cancersetting, PARP inhibitor monotherapy in a nonmetastatic castration-sensitive (nmCSPC) setting has the potential to delay metastasis and delay the onset of ADT related symptoms. This is a single-arm, single-center, open-label, phase II trial to assess the efficacy of rucaparib in patients with high-risk biochemically recurrent (BCR) nmHSPC, which was defined as PSA doubling time of <9 months, demonstrating a "BRCAness" genotype (BRCA1/2 and other homologous recombination repair mutations). A total of 15 patients were intended to be enrolled, with an expected enrollment duration of 12 months. Patients were given rucaparib 600 mg orally twice daily and were allowed to remain on study treatment until PSA progression defined by Prostate Cancer Working Group 3, with 2 years of follow-up after study treatment. We anticipated a total of 2-3 years until completion of the clinical trial. The primary endpoint was to assess the PSA progression-free survival (PSA-PFS). The secondary endpoints of the study were safety, the proportion of patients with a PSA 50% response (PSA 50), and an undetectable PSA. A 4-week treatment duration comprised one cycle. The study started enrolling in June 2019 and was prematurely terminated in June 2022 after the accrual of 7 patients because of changing standard of care treatments with the introduction of next-generation scans, eg, prostate-specific membrane antigen positron emission tomography (PSMA-PET). Seven patients were enrolled in the study with the following pathogenic alterations: ATM (n = 3), BRCA2 (n = 2), BRCA1 (n = 1), BRIP1 (n = 1), and RAD51 (n = 1). The median duration of follow-up was 18 months. A median of 20 cycles (range 4-42) was completed, median PSA-PFS was 35.37 months (95% CI, 0-85.11 months). In total, 2 patients achieved PSA50; both also achieved nadir PSA as undetectable. Grade ≥ 3 adverse events (AEs) were anemia and rash (in 1 patient each). No dose-limiting toxicities or severe AEs were seen. Rucaparib demonstrated acceptable toxicity and efficacy signal as an ADT-sparing approach in patients with biochemically recurrent nonmetastatic prostate cancer. It is currently challenging to understand the optimal value of systemic therapy in this disease setting due to the rapidly changing standard of care. Additionally, there are relatively few patients with BRCAness who present with nonmetastatic hormone-sensitive prostate cancer (ClinicalTrials.gov Identifier: NCT03533946).

Medicare, Medicaid, and dual enrollment for adults with intellectual and developmental disabilities.

Given high rates of un- and underemployment among disabled people, adults with intellectual and developmental disabilities rely on Medicaid, Medicare, or both to pay for healthcare. Many disabled adults are Medicare eligible before the age of 65 but little is known as to why some receive Medicare services while others do not. We described the duration of Medicare enrollment for adults with intellectual and developmental disabilities in 2019 and then compared demographics by enrollment type (Medicare-only, Medicaid-only, dual-enrolled). Additionally, we examined the percent in each enrollment type by state, and differences in enrollment type for those with Down syndrome. 2019 Medicare and Medicaid claims data for all adults (≥18 years) in the US with claim codes for intellectual disability, Down syndrome, or autism at any time between 2011 and 2019. Administrative claims cohort. Data were from the Transformed Medicaid Statistical Information System Analytic Files and Medicare Beneficiary Summary files. In 2019, Medicare insured 582,868 adults with identified intellectual disability, autism, or Down syndrome. Of 582,868 Medicare beneficiaries, 149,172 were Medicare only and 433,396 were dual-enrolled. Most Medicare enrollees were enrolled as child dependents (61.5%) Medicaid-only enrollees (N = 819,256) were less likely to be white non-Hispanic (58.5% white non-Hispanic vs. 72.9% white non-Hispanic in dual-enrolled), more likely to be Hispanic (19.6% Hispanic vs. 9.2% Hispanic in dual-enrolled) and were younger (mean 34.2 years vs. 50.5 years dual-enrolled). There is heterogeneity in public insurance enrollment which is associated with state and disability type. Action is needed to ensure all are insured in the program that works for their healthcare needs.