Analysis of eligibility criteria in Alzheimer's and related dementias clinical trials.

Overly restrictive clinical trial eligibility criteria can reduce generalizability, slow enrollment, and disproportionately exclude historically underrepresented populations. The eligibility criteria for 196 Alzheimer's Disease and Related Dementias (AD/ADRD) trials funded by the National Institute on Aging were analyzed to identify common criteria and their potential to disproportionately exclude participants by race/ethnicity. The trials were categorized by type (48 Phase I/II pharmacological, 7 Phase III/IV pharmacological, 128 non-pharmacological, 7 diagnostic, and 6 neuropsychiatric) and target population (51 AD/ADRD, 58 Mild Cognitive Impairment, 25 at-risk, and 62 cognitively normal). Eligibility criteria were coded into the following categories: Medical, Neurologic, Psychiatric, and Procedural. A literature search was conducted to describe the prevalence of disparities for eligibility criteria for African Americans/Black (AA/B), Hispanic/Latino (H/L), American Indian/Alaska Native (AI/AN) and Native Hawaiian/Pacific Islander (NH/PI) populations. The trials had a median of 15 criteria. The most frequent criterion were age cutoffs (87% of trials), specified neurologic (65%), and psychiatric disorders (61%). Underrepresented groups could be disproportionately excluded by 16 eligibility categories; 42% of trials specified English-speakers only in their criteria. Most trials (82%) contain poorly operationalized criteria (i.e., criteria not well defined that can have multiple interpretations/means of implementation) and criteria that may reduce racial/ethnic enrollment diversity.

Medicare Eligibility and Changes in Coverage, Access to Care, and Health by Sexual Orientation and Gender Identity.

Importance: Medicare provides nearly universal insurance coverage at age 65 years. However, how Medicare eligibility affects disparities in health insurance coverage, access to care, and health status among individuals by sexual orientation and gender identity is poorly understood. Objective: To assess the association of Medicare eligibility with disparities in health insurance coverage, access to care, and self-reported health status among individuals by sexual orientation and by gender identity. Design, Setting, and Participants: This cross-sectional study used the age discontinuity for Medicare eligibility at age 65 years to isolate the association of Medicare with health insurance coverage, access to care, and self-reported health status, by their sexual orientation and by their gender identity. Data were collected from the Behavioral Risk Factor Surveillance System for respondents from 51 to 79 years old from 2014 to 2021. Data analysis was performed from September 2022 to April 2023. Exposures: Medicare eligibility at age 65 years. Main Outcomes and Measures: Proportions of respondents with health insurance coverage, usual source of care, cost barriers to care, influenza vaccination, and self-reported health status. Results: The study population included 927 952 individuals (mean [SD] age, 64.4 [7.7] years; 524 972 [56.6%] females and 402 670 [43.4%] males), of whom 28 077 (3.03%) identified as a sexual minority-lesbian, gay, bisexual, or another sexual minority identity (LGB+) and 3286 (0.35%) as transgender or gender diverse. Respondents who identified as heterosexual had greater improvements at age 65 years in insurance coverage (4.2 percentage points [pp]; 95% CI, 4.0-4.4 pp) than those who identified as LGB+ (3.6 pp; 95% CI, 2.3-4.8 pp), except when the analysis was limited to a subsample of married respondents. For access to care, improvements in usual source of care, cost barriers to care, and influenza vaccination were larger at age 65 years for heterosexual respondents compared with LGB+ respondents, although confidence intervals were overlapping and less precise for LGB+ individuals. For self-reported health status, the analyses found larger improvements at age 65 years for LGB+ respondents compared with heterosexual respondents. There was considerable heterogeneity by state in disparities by sexual orientation among individuals who were nearly eligible for Medicare (close to 65 years old), with the US South and Central states demonstrating the highest disparities. Among the top-10 highest-disparities states, Medicare eligibility was associated with greater increases in coverage (6.7 pp vs 5.0 pp) and access to a usual source of care (1.4 pp vs 0.6 pp) for LGB+ respondents compared with heterosexual respondents. Conclusions and Relevance: The findings of this cross-sectional study indicate that Medicare eligibility was not associated with consistently greater improvements in health insurance coverage and access to care among LGBTQI+ individuals compared with heterosexual and/or cisgender individuals. However, among sexual minority individuals, Medicare may be associated with closing gaps in self-reported health status, and among states with the highest disparities, it may improve health insurance coverage, access to care, and self-reported health status.

National and State Estimates of SELECT Trial Eligibility and Its Public Health Impact in the US.

This cross-sectional study of US adults examines the geographical distribution of individuals eligible to participate in the Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (SELECT) trial to estimate potential cardiovascular health impacts of implementing the trial findings at state and national levels.

The impacts of supplemental benefits on Medicare Advantage plan composition.

OBJECTIVES: In 2019 and 2020, Medicare Advantage (MA) plans received historic flexibility to begin to address members' nonmedical and social needs through a set of primarily health-related benefits (PHRBs) and Special Supplemental Benefits for the Chronically Ill (SSBCIs). We aimed to evaluate the impact of adoption on the number and composition of new MA plan enrollees. STUDY DESIGN: A difference-in-differences design of retrospective Medicare enrollment data linked to publicly available plan and county-level data. METHODS: We linked individual-level Medicare enrollment data to publicly available, plan-level MA benefit, crosswalk, and penetration files from 2016 to 2020. We compared the number of new enrollees and the proportion of new enrollees who were Black, Hispanic, younger than 65 years, partially and fully Medicare and Medicaid dual eligible, and disabled in plans that adopted a PHRB or SSBCI vs a set of matched control plans that did not. RESULTS: In fully adjusted models, PHRB adoption was associated with a 2.2% decrease in the proportion of fully dual-eligible new members (95% CI, -4.0% to -0.5%). SSBCI adoption was associated with a 2.3% decrease in the proportion of new members younger than 65 years (95% CI, -3.6% to -0.9%). After accounting for multiple comparisons, these results were no longer statistically significant. CONCLUSION: We determined that supplemental benefit adoption was not associated with demographic shifts in MA plan enrollment.

Aged care service use by Aboriginal and Torres Strait Islander people after aged care eligibility assessments, 2017-2019: a population-based retrospective cohort study.

OBJECTIVE: To characterise the socio-demographic characteristics, aged and health care needs, and aged care services used by older Aboriginal and Torres Strait Islander people assessed for aged care service eligibility. STUDY DESIGN: Population-based retrospective cohort study; analysis of Registry of Senior Australians (ROSA) National Historical Cohort data. SETTING, PARTICIPANTS: Aboriginal and Torres Strait Islander people aged 50 years or older who were first assessed for aged care service eligibility (permanent residential aged care, home care package, respite care, or transition care) during 1 January 2017 - 31 December 2019. MAJOR OUTCOME MEASURES: Socio-demographic and aged care assessment characteristics; health conditions and functional limitations recorded at the time of the assessment; subsequent aged care service use. RESULTS: The median age of the 6209 people assessed for aged care service eligibility was 67 years (interquartile range [IQR], 60-75 years), 3626 were women (58.4%), and 4043 lived in regional to very remote areas of Australia (65.1%). Aboriginal health workers were involved in 655 eligibility assessments (10.5%). The median number of health conditions was six (IQR, 4-8); 6013 (96.9%) had two or more health conditions, and 2592 (41.8%) had seven or more. Comorbidity was most frequent among people with mental health conditions: 597 of 1136 people with anxiety (52.5%) and 1170 of 2416 people with depression (48.5%) had seven or more other medical conditions. Geriatric syndromes were recorded for 2265 people (36.5%); assistance with at least one functional activity was required by 6190 people (99.7%). A total of 6114 people (98.5%) were approved for at least one aged care service, 3218 of whom (52.6%) subsequently used these services; the first services used were most frequently home care packages (1660 people, 51.6%). CONCLUSION: Despite the high care needs of older Aboriginal and Torres Strait Islander people, only 52% used aged care services for which they were eligible. It is likely that the health and aged care needs of older Aboriginal and Torres Strait Islander people are not being adequately met.

Beneficiary Experience of Care by Level of Integration in Dual Eligible Special Needs Plans.

Importance: Dual Eligible Special Needs Plans (D-SNPs) are private managed care plans designed to promote Medicare and Medicaid integration for full-benefit, dually eligible beneficiaries. Currently, the highest level of D-SNP integration occurs in plans with exclusively aligned enrollment (EAE). Objective: To compare patient experience of care, out-of-pocket spending, and satisfaction among dually enrolled Medicaid beneficiaries in D-SNPs with EAE, those in D-SNPs without EAE, and those with traditional Medicare. Design, Setting, and Participants: This cross-sectional study included respondents to a mail survey fielded to a stratified random sample of full-benefit, community-dwelling, dual-eligible Medicaid beneficiaries who qualified for receipt of home and community-based services in the Virginia Medicaid Commonwealth Coordinated Care Plus program between March and October 2022. Exposure: Enrollment in a D-SNP with EAE or a D-SNP without EAE vs traditional Medicare. Main Outcomes and Measures: The main outcomes were self-reported measures of access and delays in receiving plan approvals, out-of-pocket spending, and satisfaction with health plans' customer service and choice of primary care and specialist physicians. Results: Of 7200 surveys sent, 2226 were completed (response rate, 30.9%). The analytic sample consisted of 1913 Medicaid beneficiaries with nonmissing data on covariates (mean [SD] age, 70.8 [15.6] years; 1367 [71.5%] female). Of these, 583 (30.5%) were enrolled in D-SNPs with EAE, 757 (39.6%) in D-SNPs without EAE, and 573 (30.0%) in traditional Medicare. Compared with respondents enrolled in D-SNPs without EAE, those in D-SNPs with the highest level of integration (EAE) were 6.77 percentage points (95% CI, 8.81-12.66 percentage points) more likely to report being treated with courtesy and respect and 5.83 percentage points (95% CI, 0.21-11.46 percentage points) more likely to know who to call when they had a health problem. No statistically significant differences were found between members in either type of D-SNP and between those in D-SNPs and traditional Medicare in terms of their difficulty accessing care, delays in care, and satisfaction with care coordination and physician choice. Conclusions and Relevance: This cross-sectional study found some benefits of integrating administrative processes under Medicare and Medicaid but suggests that care coordination and access improvements under full integration require additional time and/or efforts to achieve.

Projections of Endovascular Therapy-Eligible Patients With Stroke for the US Population.

BACKGROUND: As stroke endovascular thrombectomy (EVT) treatment indications expand, understanding population-based EVT eligibility becomes critical for resource planning. We aimed to project current and future population-based EVT eligibility in the United States. METHODS: We conducted a post hoc analysis of the physician-adjudicated GCNKSS (Greater Cincinnati Northern Kentucky Stroke Study; 2015 epoch), a population-based, cross sectional, observational study of stroke incidence, treatment, and outcomes across a 5-county region. All hospitalized patients ≥18 years of age with acute ischemic stroke were ascertained using the International Classification of Diseases, Ninth Revision codes 430-436 and Tenth Revision codes I60-I67 and G45-G46 and extrapolated to the US adult census 2020. We determined the rate of EVT eligibility within the GCNKSS population using time from last known well to presentation (0-5 versus 5-23 hours), presenting National Institutes of Health Stroke Scale, and prestroke modified Rankin Scale. Both conservative and liberal estimates of prevalence of large vessel occlusion and large core were then applied based on literature review (unavailable within the 2015 GCNKSS). This eligibility was then extrapolated to the 2020 US population. RESULTS: Of the 1 057 183 adults within GCNKSS in 2015, 2741 had an ischemic stroke and 2176 had data available for analysis. We calculated that 8659 to 17 219 patients (conservative to liberal) meet the current guideline-recommended EVT criteria (nonlarge core, no prestroke disability, and National Institutes of Health Stroke Scale score ≥6) in the United States. Estimates (conservative to liberal) for expanded EVT eligibility subpopulations include (1) 5316 to 10 635 by large core; (2) 10 635 to 21 270 by mild presenting deficits with low National Institutes of Health Stroke Scale score; (3) 13 572 to 27 089 by higher prestroke disability; and (4) 7039 to 14 180 by >1 criteria. These expanded eligibility subpopulations amount to 36 562 to 73 174 patients. CONCLUSIONS: An estimated 8659 to 17 219 adult patients in the United States met strict EVT eligibility criteria in 2020. A 4-fold increase in population-based EVT eligibility can be anticipated with incremental adoption of recent or future positive trials. US stroke systems need to be rapidly optimized to handle all EVT-eligible patients with stroke.

Medicaid Enrollment and Intergenerational Transfers of Wealth Among Older Adults.

BACKGROUND AND OBJECTIVES: Medicaid look-back periods are meant to prevent Medicaid applicants from gifting assets to meet eligibility requirements. These policies have the potential to affect families across generations given their ability to restrict the transfer of assets between parent and child. RESEARCH DESIGN AND METHODS: Using 2008-2018 data from the Health and Retirement Study, this study analyzed the estate planning and familial wealth transfer behaviors of a cohort of older adults aged 65 and older who became Medicaid recipients during a 10-year period. RESULTS: There were 8,347 respondents aged 65 and older in 2008 and 11.96% of respondents who were not Medicaid recipients at baseline became recipients over the study period. A little more than one third (36.47%) of Medicaid recipients participated in estate planning and asset transfer prior to becoming a recipient, with significant differences among select demographic characteristics. Married recipients were more likely to transfer money compared to their widowed counterparts (51.69% compared to 36.44%; p < .001) and transferred larger amounts compared to those unmarried ($16,286.94 compared to 5,379.13). White, well-educated, married, men participated in higher rates of estate planning, likely a reflection of who has access to resources to make necessary arrangements early. DISCUSSION AND IMPLICATIONS: This analysis concludes that more structurally advantaged groups are more likely to engage in estate planning prior to Medicaid enrollment. This analysis demonstrates that some individuals may circumvent Medicaid policies like look-back periods and estate recovery, while others cannot. Policymakers should consider policies that promote the financial health of low-income families.

Evaluating the robustness of an AI pathfinder application on eligibility criteria in multiple myeloma trials using real-world data and historical trials.

Background: Eligibility criteria are pivotal in achieving clinical trial success, enabling targeted patient enrollment while ensuring the trial safety. However, overly restrictive criteria hinder enrollment and study result generalizability. Broadening eligibility criteria enhances the trial inclusivity, diversity and enrollment pace. Liu et al. proposed an AI pathfinder method leveraging real-world data to broaden criteria without compromising efficacy and safety outcomes, demonstrating promise in non-small cell lung cancer trials. Aim: To assess the robustness of the methodology, considering diverse qualities of real-world data and to promote its application. Materials/Methods: We revised the AI pathfinder method, applied it to relapsed and refractory multiple myeloma trials and compared it using two real-world data sources. We modified the assessment and considered a bootstrap confidence interval of the AI pathfinder to enhance the decision robustness. Results & conclusion: Our findings confirmed the AI pathfinder's potential in identifying certain eligibility criteria, in other words, prior complications and laboratory tests for relaxation or removal. However, a robust quantitative assessment, accounting for trial variability and real-world data quality, is crucial for confident decision-making and prioritizing safety alongside efficacy.

The Medical Costs of Determining Eligibility and Waiting for a Kidney Transplantation.

BACKGROUND: Recent efforts to increase access to kidney transplant (KTx) in the United States include increasing referrals to transplant programs, leading to more pretransplant services. Transplant programs reconcile the costs of these services through the Organ Acquisition Cost Center (OACC). OBJECTIVE: The aim of this study was to determine the costs associated with pretransplant services by applying microeconomic methods to OACC costs reported by transplant hospitals. RESEARCH DESIGN, SUBJECTS, AND MEASURES: For all US adult kidney transplant hospitals from 2013 through 2018 (n=193), we crosslinked the total OACC costs (at the hospital-fiscal year level) to proxy measures of volumes of pretransplant services. We used a multiple-output cost function, regressing total OACC costs against proxy measures for volumes of pretransplant services and adjusting for patient characteristics, to calculate the marginal cost of each pretransplant service. RESULTS: Over 1015 adult hospital-years, median OACC costs attributable to the pretransplant services were $5 million. Marginal costs for the pretransplant services were: initial transplant evaluation, $9k per waitlist addition; waitlist management, $2k per patient-year on the waitlist; deceased donor offer management, $1k per offer; living donor evaluation, procurement and follow-up: $26k per living donor. Longer time on dialysis among patients added to the waitlist was associated with higher OACC costs at the transplant hospital. CONCLUSIONS: To achieve the policy goals of more access to KTx, sufficient funding is needed to support the increase in volume of pretransplant services. Future studies should assess the relative value of each service and explore ways to enhance efficiency.

"How Will Medicaid Work Requirements Affect American Healthcare? A Look at What Past and Present Policy Tells Us".

Many social services have work requirements. Notably, Medicaid has no requirement that healthy, able-bodied beneficiaries work to receive benefits. There have been attempts at incorporating work requirement policies into several US states, but only a few have been implemented. The effect of work requirements has been studied in several other federally funded programs such as TANF, SNAP, and historically in the Civilian Corps created by Franklin Roosevelt. In general, these programs seem to have modest improvements in employment but are better when implemented with work supports which show improvement in employment and income. In this study, we examine the history of work requirements in Medicaid and other social programs to see which policies have the most effect on enrollment and employment.

Racial Disparities in Endometrial Cancer Clinical Trial Representation: Exploring the Role of Eligibility Criteria.

OBJECTIVE: This study aimed to determine whether Black patients with recurrent endometrial cancer were more likely than White patients to be ineligible for a recently published clinical trial due to specific eligibility criteria. METHODS: Patients with recurrent or progressive endometrial cancer diagnosed from January 2010 to December 2021 who received care at a single institution were identified. Demographic and clinicopathologic information was abstracted and determination of clinical trial eligibility was made based on 14 criteria from the KEYNOTE-775 trial. Characteristics of the eligible and ineligible cohorts were compared, and each ineligibility criterion was evaluated by race. RESULTS: One hundred seventy-five patients were identified, 89 who would have met all inclusion and no exclusion criteria for KEYNOTE-775, and 86 who would have been ineligible by one or more exclusion criteria. Patients in the ineligible cohort were more likely to have lower BMI (median 26.5 vs. 29.2, P <0.001), but were otherwise similar with regard to insurance status, histology, and stage at diagnosis. Black patients had 33% lower odds of being eligible (95% CI: 0.33-1.34) and were more likely to meet the exclusion criterion of having a previous intestinal anastomosis, but the result was not statistically significant. If this criterion were removed, the racial distribution of those ineligible for the trial would be more similar (46.4% Black vs. 42.2% White). CONCLUSIONS: Clinical trial eligibility criteria may contribute to the underrepresentation of racial groups in clinical trials, but other factors should be explored. Studies to quantify and lessen the impact of implicit bias are also needed.

Representativeness of Participants in the ACCORD Trial Compared to Middle-aged and Older Adults Living with Diabetes in the United States.

BACKGROUND: We evaluated whether participants in the landmark Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial represent US adults aged ≥40 with diabetes. METHODS: Using the nationally representative 2017-2020 prepandemic National Health and Nutrition Examination Survey data, we made operational definitions of ACCORD eligibility criteria. We calculated the percentage of individuals aged ≥40 with diabetes and HbA1c ≥ 6.0% or ≥ 7.5% who met operational ACCORD eligibility criteria. RESULTS: Applying survey sampling weights to 715 National Health and Nutrition Examination Survey participants aged ≥40 with diabetes and HbA1c ≥ 6.0% (representing 29,717,406 individuals), 12% (95% confidence interval [CI] = 8%, 18%) met the operational ACCORD eligibility criteria. Restricting to HbA1c ≥ 7.5%, 39% (95% CI = 28%, 51%) of respondents met the operational ACCORD eligibility criteria. CONCLUSIONS: ACCORD represented a minority of US middle-aged and older adults with diabetes. Given the differential risk profile between ACCORD participants and the general population with diabetes, extrapolating the trial findings may not be appropriate.

The effect of retirement eligibility on mental health in the United Kingdom: Heterogeneous effects by occupation.

I investigate heterogeneity across occupational characteristics in the effect of retirement eligibility on mental health in the United Kingdom. I use K-means clustering to define three occupational clusters, differing across multiple dimensions. I estimate the effect of retirement eligibility using a Regression Discontinuity Design, allowing the effect to differ by cluster. The effects of retirement eligibility are beneficial, and greater in two clusters: one comprised of white-collar jobs in an office setting and another of blue-collar jobs with high physical demands and hazards. The cluster with smaller benefits mixes blue- and white-collar uncompetitive jobs with high levels of customer interaction. The results have implications for the distributional effect of raising the retirement age.