A MINDful Path To Better Dementia Care For Dual-Eligible Adults.

With care coordination, problem solving, and an array of services, a model program helps dually eligible Medicare and Medicaid patients and their caregivers cope with dementia challenges.

The Continuing Quest To Integrate Care For Dual-Eligible Enrollees.

For people dually eligible for Medicare and Medicaid, one integrated care plan option is coming to an end. States are planning what to offer next.

Newly and Previously Eligible Medicaid Enrollees Differ, but Not in Health Care Expenditures.

In 2014, the Affordable Care Act (ACA) expanded the role of Medicaid by encouraging states to increase eligibility for lower-income adults. As of 2024, 10 states had not adopted the expanded eligibility provisions of the ACA, possibly due to concerns about the state's share of spending. Using the Medical Expenditure Panel Survey (MEPS), we documented how health care utilization, expenditures, and the overall health status of newly eligible enrollees compare with enrollees who would have been eligible under their states' rules before the ACA. Our estimates suggest that, during 2014-16, newly eligible Medicaid enrollees had worse health and greater utilization and expenditures than previously eligible enrollees. However, during 2017-19, newly and previously eligible enrollees had comparable per capita health expenditures across six types of health spending. We find some evidence that changes in Medicaid enrollment composition muted observed differences between eligibility groups.

Role of age as eligibility criterion for ECMO in patients with ARDS: meta-regression analysis.

BACKGROUND: Age as an eligibility criterion for V-V ECMO is widely debated and varies among healthcare institutions. We examined how age relates to mortality in patients undergoing V-V ECMO for ARDS. METHODS: Systematic review and meta-regression of clinical studies published between 2015 and June 2024. Studies involving at least 6 ARDS patients treated with V-V ECMO, with specific data on ICU and/or hospital mortality and patient age were included. The search strategy was executed in PubMed, limited to English-language. COVID-19 and non-COVID-19 populations were analyzed separately. Meta-regressions of mortality outcomes on age were performed using gender, BMI, SAPS II, APACHE II, Charlson comorbidity index or SOFA as covariates. RESULTS: In non-COVID ARDS, the meta-regression of 173 studies with 56,257 participants showed a significant positive association between mean age and ICU/hospital mortality. In COVID-19 ARDS, a significant relationship between mean age and ICU mortality, but not hospital mortality, was found in 103 studies with 21,255 participants. Sensitivity analyses confirmed these findings, highlighting a linear relationship between age and mortality in both groups. For each additional year of mean age, ICU mortality increased by 1.2% in non-COVID ARDS and 1.9% in COVID ARDS. CONCLUSIONS: The relationship between age and ICU mortality is linear and shows no inflection point. Consequently, no age cut-off can be recommended for determining patient eligibility for V-V ECMO.

Vital Signs: Trends and Disparities in Childhood Vaccination Coverage by Vaccines for Children Program Eligibility - National Immunization Survey-Child, United States, 2012-2022.

Introduction: The Vaccines for Children (VFC) program was established in 1994 to provide recommended vaccines at no cost to eligible children and help ensure that all U.S. children are protected from life-threatening vaccine-preventable diseases. Methods: CDC analyzed data from the 2012-2022 National Immunization Survey-Child (NIS-Child) to assess trends in vaccination coverage with ≥1 dose of measles, mumps, and rubella vaccine (MMR), 2-3 doses of rotavirus vaccine, and a combined 7-vaccine series, by VFC program eligibility status, and to examine differences in coverage among VFC-eligible children by sociodemographic characteristics. VFC eligibility was defined as meeting at least one of the following criteria: 1) American Indian or Alaska Native; 2) insured by Medicaid, Indian Health Service (IHS), or uninsured; or 3) ever received at least one vaccination at an IHS-operated center, Tribal health center, or urban Indian health care facility. Results: Overall, approximately 52.2% of U.S. children were VFC eligible. Among VFC-eligible children born during 2011-2020, coverage by age 24 months was stable for ≥1 MMR dose (88.0%-89.9%) and the combined 7-vaccine series (61.4%-65.3%). Rotavirus vaccination coverage by age 8 months was 64.8%-71.1%, increasing by an average of 0.7 percentage points annually. Among all children born in 2020, coverage was 3.8 (≥1 MMR dose), 11.5 (2-3 doses of rotavirus vaccine), and 13.8 (combined 7-vaccine series) percentage points lower among VFC-eligible than among non-VFC-eligible children. Conclusions and implications for public health practice: Although the VFC program has played a vital role in increasing and maintaining high levels of childhood vaccination coverage for 30 years, gaps remain. Enhanced efforts must ensure that parents and guardians of VFC-eligible children are aware of, have confidence in, and are able to obtain all recommended vaccines for their children.

U.S. Medical Eligibility Criteria for Contraceptive Use, 2024.

The 2024 U.S. Medical Eligibility Criteria for Contraceptive Use (U.S. MEC) comprises recommendations for the use of specific contraceptive methods by persons who have certain characteristics or medical conditions. These recommendations for health care providers were updated by CDC after review of the scientific evidence and a meeting with national experts in Atlanta, Georgia, during January 25-27, 2023. The information in this report replaces the 2016 U.S. MEC (CDC. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR 2016:65[No. RR-3]:1-103). Notable updates include 1) the addition of recommendations for persons with chronic kidney disease; 2) revisions to the recommendations for persons with certain characteristics or medical conditions (i.e., breastfeeding, postpartum, postabortion, obesity, surgery, deep venous thrombosis or pulmonary embolism with or without anticoagulant therapy, thrombophilia, superficial venous thrombosis, valvular heart disease, peripartum cardiomyopathy, systemic lupus erythematosus, high risk for HIV infection, cirrhosis, liver tumor, sickle cell disease, solid organ transplantation, and drug interactions with antiretrovirals used for prevention or treatment of HIV infection); and 3) inclusion of new contraceptive methods, including new doses or formulations of combined oral contraceptives, contraceptive patches, vaginal rings, progestin-only pills, levonorgestrel intrauterine devices, and vaginal pH modulator. The recommendations in this report are intended to serve as a source of evidence-based clinical practice guidance for health care providers. The goals of these recommendations are to remove unnecessary medical barriers to accessing and using contraception and to support the provision of person-centered contraceptive counseling and services in a noncoercive manner. Health care providers should always consider the individual clinical circumstances of each person seeking contraceptive services. This report is not intended to be a substitute for professional medical advice for individual patients; when needed, patients should seek advice from their health care providers about contraceptive use.

Adolescent Mental Health and Suicidal Behaviors in the Context of Expanded Supplemental Nutrition Assistance Program Eligibility.

PURPOSE: Food insecurity is a risk factor for poor mental health and suicidal behaviors among adolescents. Prior research shows that states with policies that expand Supplemental Nutrition Assistance Program (SNAP) eligibility have a lower prevalence of food insecurity. The primary aim of this study was to compare the prevalence of feelings of sadness or hopelessness, suicidal ideation, and suicide attempts among adolescents in states that had the asset test eliminated and the income limit increased for SNAP eligibility to adolescents in states that did not have either policy. METHODS: Using 2013-2021 data from state Youth Risk Behavior Surveys (N = 855,119) and the SNAP Policy Database, we conducted log-binomial regression with generalized estimating equations and adjusted for confounders. RESULTS: The prevalence of persistent feelings of sadness or hopelessness was similar among adolescents in states that had the asset test eliminated only and among adolescents in states that had both the asset test eliminated and the income limit increased (i.e., both policies) compared to adolescents in states that did not have either policy. While the prevalence of suicidal thoughts was similar among adolescents in states that had the asset test eliminated only compared to adolescents in states that did not have either policy, the prevalence of suicidal thoughts (prevalence ratio = 0.91, 95% CI 0.88, 0.94) and suicide attempts (prevalence ratio = 0.82, 95% CI 0.78, 0.86) was lower among adolescents in states that had both policies compared to adolescents in states that did not have either policy. DISCUSSION: States with policies that expand SNAP eligibility have a lower prevalence of suicidal behaviors among adolescents.

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.

Hospital Presumptive Eligibility Emergency Medicaid Programs: An Opportunity for Continuous Insurance Coverage?

BACKGROUND: Lack of health insurance is a public health crisis, leading to foregone care and financial strain. Hospital Presumptive Eligibility (HPE) is a hospital-based emergency Medicaid program that provides temporary (up to 60 d) coverage, with the goal that hospitals will assist patients in applying for ongoing Medicaid coverage. It is unclear whether HPE is associated with successful longer-term Medicaid enrollment. OBJECTIVE: To characterize Medicaid enrollment 6 months after initiation of HPE and determine sociodemographic, clinical, and geographic factors associated with Medicaid enrollment. DESIGN: This was a cohort study of all HPE approved inpatients in California, using claims data from the California Department of Healthcare Services. SETTING: The study was conducted across all HPE-participating hospitals within California between January 1, 2016 and December 31, 2017. PARTICIPANTS: We studied California adult hospitalized inpatients, who were uninsured at the time of hospitalization and approved for HPE emergency Medicaid. Using multivariable logistic regression models, we compared HPE-approved patients who enrolled in Medicaid by 6 months versus those who did not. EXPOSURES: HPE emergency Medicaid approval at the time of hospitalization. MAIN OUTCOMES AND MEASURES: The primary outcome was full-scope Medicaid enrollment by 6 months after the hospital's presumptive eligibility approval. RESULTS: Among 71,335 inpatient HPE recipients, a total of 45,817 (64.2%) enrolled in Medicaid by 6 months. There was variability in Medicaid enrollment across counties in California (33%-100%). In adjusted analyses, Spanish-preferred-language patients were less likely to enroll in Medicaid (aOR 0.77, P <0.001). Surgical intervention (aOR 1.10, P <0.001) and discharge to another inpatient facility or a long-term care facility increased the odds of Medicaid enrollment (vs. routine discharge home: aOR 2.24 and aOR 1.96, P <0.001). CONCLUSION: California patients who enroll in HPE often enroll in Medicaid coverage by 6 months, particularly among patients requiring surgical intervention, repeated health care visits, and ongoing access to care. Future opportunities include prospective evaluation of HPE recipients to understand the impact that Medicaid enrollment has on health care utilization and financial solvency.

Evaluating the impact of laboratory-based eligibility criteria by race/ethnicity in first-line clinical trials of DLBCL.

ABSTRACT: Underrepresentation of racial and ethnic subgroups in cancer clinical trials remains a persistent challenge. Restrictive clinical trial eligibility criteria have been shown to exacerbate this problem. We previously identified that up to 24% of patients treated with standard immunochemotherapy would have been excluded from recent first-line trials in diffuse large B-cell lymphoma (DLBCL) based on 5 laboratory-based criteria. These ineligible patients had worse clinical outcomes and increased deaths related to lymphoma progression, suggesting the potential exclusion of patients who could have benefited most from the novel therapies being evaluated. Using data from the prospectively enrolled Lymphoma Epidemiology Outcomes cohort study, with demographics broadly similar to the US patients diagnosed with lymphoma, we evaluated the impact of laboratory eligibility criteria from recent first-line DLBCL trials across various racial and ethnic backgrounds. There were significant differences in the baseline laboratory values by race/ethnicity with Black/African American (AA) patients having the lowest mean hemoglobin and highest creatinine clearance. Based on recent clinical trial eligibility criteria, AA and Hispanic patients had higher rates of laboratory-based ineligibility than non-Hispanic White patients. The largest gap in the clinical outcomes between eligible and noneligible patients was noted within AA patients with an overall survival hazard ratio based on POLARIX clinical trial criteria of 4.09 (95% confidence interval, 1.83-9.14). A thoughtful approach to the utility of each criterion and cutoffs for eligibility needs to be evaluated in the context of its differential impact across various racial/ethnic groups.

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.

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.

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.

Eligibility to COAPT trial in the daily practice: A real-world experience.

BACKGROUND: The COAPT Trial was the first ever to demonstrate a survival benefit in treating functional mitral regurgitation (FMR). That was achieved through transcatheter mitral repair in selected patients. The exact proportion of patients fulfilling COAPT selection criteria in the real-world is unknown. AIMS: To assess the applicability of COAPT criteria in real world and its impact on patients' survival. METHODS: We assessed the clinical data and follow-up results of all consecutive patients admitted for FMR at our Department between January 2016 and May 2021 according to COAPT eligibility. COAPT eligibility was retrospectively assessed by a cardiac surgeon and a cardiologist. RESULTS: Among 394 patients, 56 (14%) were COAPT eligible. The most frequent reasons for exclusion were MR ≤ 2 (22%), LVEF < 20% or >50% (19%), and non-optimized GDMT (21.3%). Among Non-COAPT patients, weighted 4-year survival was higher in patients who received MitraClip compared to those who were left in optimized medical therapy (91.5% confidence interval [CI: 0.864, 0.96] vs. 71.8% [CI: 0.509, 0.926], respectively, p = 0.027). CONCLUSIONS: Only a minority (14%) of real-world patients with FMR referred to a tertiary hospital fulfilled the COAPT selection criteria. Among Non-COAPT patients, weighted 4-year survival was higher in patients who received MitraClip compared to those who were left in optimized medical therapy (91.5% [0.864, 0.96] vs. 71.8% [0.509, 0.926], respectively, p = 0.027).

Eligibility for antiamyloid treatment: preparing for disease-modifying therapies for Alzheimer's disease.

BACKGROUND: Disease-modifying therapies (DMTs) for Alzheimer's disease (AD) have early evidence of efficacy. Widespread delivery of DMTs will require major service reconfiguration. Treatment pathways will need to include triaging for eligibility, regular infusions and baseline and follow-up MRI scanning. A critical step in planning is provision of real-world estimates of patients likely to be eligible for triaging, but these are challenging to obtain. METHODS: We performed a retrospective service evaluation of patients attending five memory services across North and East London and a national specialist cognitive disorders service. We examined the likely proportion of patients who would (1) be referred for triaging for DMTs and (2) potentially be suitable for treatments. RESULTS: Data from a total of 1017 patients were included, 517 of whom were seen in community memory services and 500 in a specialist clinic. In the memory services, 367/517 (71%) were diagnosed with possible AD. After exclusions of those in whom cognitive and frailty scores, MRI contraindications or anticoagulant use indicated they would be unlikely to be suitable, an estimated 32% would be eligible for triaging. In the specialist cognitive clinic, where additional investigations are available, 14% of those seen (70/500) would be potentially eligible for treatment. CONCLUSIONS: While a sizeable proportion of patients attending memory clinics may be referred for triaging for DMTs for AD, only a minority are likely to be suitable for these, as demonstrated in patients seen in specialist cognitive services. This will need to be considered when designing pathways for DMT delivery.

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.