Brief Report: Real-World Eligibility for Clinical Trials in Patients With Extensive-Stage SCLC at a Tertiary Care Center.

Introduction: The CASPIAN and IMpower133 trials revealed a significant survival benefit of chemotherapy plus immunotherapy in patients with extensive-stage SCLC. The current study characterizes the proportion of real-world patients who would have met eligibility for these trials and highlights factors influencing eligibility in the real-world setting. Methods: A retrospective analysis of patient data was conducted for stage IV patients with SCLC treated at the Cancer Centre of Southeastern Ontario, Canada. Trial eligibility was based on criteria used in the IMpower133 and CASPIAN trials. Data were summarized using descriptive statistics. Overall survival was assessed using the Kaplan-Meier method. Results: Of the 116 patients included, only 12.1% met the overall eligibility criteria for the IMpower133 trial, and 14.7% for the CASPIAN trial. The most common reasons for ineligibility included: Eastern Cooperative Oncology Group (ECOG) 2 or greater (77.5%), inadequate organ function (48%), and the presence of brain metastases at diagnosis (37.3%). Sixty-one patients (59.8%) met two or more major ineligibility criteria. If trial eligibility was expanded to include ECOG 2 patients, an additional 10.3% would have met eligibility. The median overall survival for all-comers was 6.5 months. Conclusions: Only a small minority of real-world patients with extensive-stage SCLC would have met eligibility for the IMpower133 and CASPIAN trials, with ECOG greater than or equal to 2, inadequate organ function, and brain metastases comprising the most common reasons for trial ineligibility. Future clinical trials should expand the inclusion criteria to better represent real-world patient populations.

Eligibility for Substance Use Clinical Trials Among Emergency Psychiatry Patients: The Impact of Exclusion Criteria.

Objective: The first objective was to identify common exclusion criteria used in clinical trials. The second objective was to quantify the degree to which these criteria exclude emergency psychiatry patients. Methods: Qualitative Content Analysis was used for the first objective, identifying common exclusion criteria used in recent high-impact substance use clinical trials. A retrospective record review was used for the second objective, which examined the frequency of these exclusion criteria in a 1-month sample of adults receiving psychiatric evaluation in an emergency department. Results: Most trials had exclusions for co-occurring psychiatric problems (76.6%), medical problems (74.0%), prior or current treatment (72.7%), motivation for change (61.1%), pregnancy or lactation (57.1%), or using other specified substances of abuse (54.6%). In the clinical sample, exclusions for co-occurring psychiatric problems would make 94.7% of patients ineligible. Other exclusions had a combined effect of making 76% of patients ineligible. Conclusions: Clinical trials using typical exclusion criteria exclude nearly all emergency psychiatry patients with substance use problems.

Cisplatin eligibility in the neoadjuvant setting of patients with muscle-invasive bladder cancer undergoing radical cystectomy.

BACKGROUND: To examine the agreement of different calculated estimated glomerular filtration rate (eGFR) formulas and measured creatinine clearance (CrCI) at the primary diagnosis of muscle-invasive bladder cancer (MIBC). MATERIALS AND METHODS: We performed a multicenter analysis of patients with MIBC, treated with cisplatin-based neoadjuvant chemotherapy (NAC) and radical cystectomy (RC), or with RC alone, between 2011 and 2021. Baseline eGFR was computed using 4 calculated serum equations including Cockcroft-Gault (CG), MDRD, CKD-EPI 2009, and race-free CKD-EPI 2021. To examine the association between calculated eGFR and measured CrCI, subgroup analyses were performed among patients in whom measured 24-hour urine CrCl was determined. Cisplatin-ineligibility was defined as CrCI and/or eGFR < 60 mL/minute per 1.73 m2. RESULTS: Of 956 patients, 30.0%, 33.3%, 31.9%, and 27.7% were found to be cisplatin-ineligible by the CG, MDRD, CKD-EPI, and race-free CKD-EPI equations (P = .052). The concordance between calculated eGFR formulas was rated substantial (Cohen's kappa (k): 0.66-0.95). Among the subgroup (n = 245) with measured CrCl, 37 (15.1%) patients had a CrCI less than 60 mL/minute. Concordance between measured CrCl and calculated eGFR was poor (ĸ: 0.29-0.40). All calculated eGFR formulas markedly underestimated the measured CrCI. Specifically, 78%-87.5% of patients with a calculated eGFR between 40 and 59 mL/minute exhibited a measured CrCI ≥ 60 mL/minute. CONCLUSIONS: Comparing calculated eGFR formulas, similar percentages of patients with MIBC were deemed cisplatin-ineligible. However, a significant number of patients could be upgraded by being cisplatin-fit based on measured CrCI, particularly when the calculated eGFR was falling within the gray range of 40-59 mL/minute.

Frequency of and reasons behind non-listing in adult patients referred for liver transplantation: Results from a retrospective study.

BACKGROUND: Few studies have evaluated the frequency of and the reasons behind the refusal of listing liver transplantation candidates. AIM: To assess the ineligibility rate for liver transplantation and its motivations. METHODS: A single-center retrospective study was conducted on adult patients which entailed a formal multidisciplinary assessment for liver transplantation eligibility. The predictors for listing were evaluated using multivariable logistic regression. RESULTS: In our center, 314 patients underwent multidisciplinary work-up before liver transplantation enlisting over a three-year period. The most frequent reasons for transplant evaluation were decompensated cirrhosis (51.6%) and hepatocellular carcinoma (35.7%). The non-listing rate was 53.8% and the transplant rate was 34.4% for the whole cohort. Two hundred and five motivations for ineligibility were collected. The most common contraindications were psychological (9.3%), cardiovascular (6.8%), and surgical (5.9%). Inappropriate or premature referral accounted for 76 (37.1%) cases. On multivariable analysis, a referral from another hospital (OR: 2.113; 95%CI: 1.259-3.548) served as an independent predictor of non-listing. CONCLUSION: A non-listing decision occurred in half of our cohort and was based on an inappropriate or premature referral in one case out of three. The referral from another hospital was taken as a strong predictor of non-listing.

Denial of Desire for Death in Dementia: Why Is Dementia Excluded from Australian Voluntary Assisted Dying Legislation?

Euthanasia in the form of Voluntary Assisted Dying (VAD) is legal in all Australian States, but current eligibility criteria preclude access to people with dementia. This article discusses Australian VAD eligibility criteria that are problematic for people with dementia: (1) time until death within 12 months, (2) decision-making capacity for VAD, and (3) determination of intolerable suffering. Legislation in the Netherlands allows VAD for people with dementia. The challenges and philosophical issues raised by such cases are explored. It is proposed that the unique nature of dementia in its various forms warrants the formulation of dementia-specific VAD eligibility criteria. A case could be brought to challenge the denial of access to VAD of people with dementia on the basis that their exclusion is discriminatory and an abuse of human rights. If such a challenge was successful, it could form a common law precedent to allow people with dementia access to VAD.

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.

The relationship between community food environment around schools and student meal participation: the role of school CEP participation status.

BACKGROUND: Despite the many benefits of school meals, not all students participate. One reason students may not participate in school meals is because they instead purchase breakfast or lunch from food outlets located around schools that mostly carry unhealthy items. This study examined whether school participation in the Community Eligibility Provision (CEP), which allows qualifying schools to serve free meals to all students, moderated the association between the community food environment around schools and student meal participation. METHODS: This study employed a longitudinal repeated-measures design using school-level data collected between 2014 and 2020 within four low-income school districts (n = 126 schools) in the US. We obtained meal participation data from state records and created a measure characterizing the community food environment within 0.25 miles of schools (characterized as low-density of unhealthy food outlets vs. high-density of unhealthy food outlets) through a latent class analysis. Regression analysis estimated associations between community food environments, CEP participation, and participation rates in school breakfast and school lunch, assessed in separate models. RESULTS: While no moderating effect of school CEP status was observed for breakfast or lunch participation, school breakfast participation was predicted to be 4% lower in high-density food environments than in low-density environments (P-value = .049) among non-CEP schools, and there was no difference in participation by the community food environment among CEP-participating schools. Differences in breakfast participation by the community food environment among non-CEP schools were mostly attributable to middle/high schools, with participation predicted to be 10% lower in high-density environments than in low-density environments among non-CEP middle/high schools (P-value < .001), whereas such a difference in participation was not observed among non-CEP elementary schools. CONCLUSIONS: Negative associations between food environment around schools and school breakfast participation were observed only among middle and high schools not participating in CEP, suggesting that policy actions to increase access to free school meals may benefit students, particularly older children and adolescents.

What Is Ailing Oncology Clinical Trials? Can We Fix Them?

Evidence from phase three clinical trials helps shape clinical practice. However, a very small minority of patients with cancer participate in clinical trials and many trials are not completed on time due to slow accrual. Issues with restrictive eligibility criteria can severely limit the patients who can access trials, without any convincing evidence that these restrictions impact patient safety. Similarly, regulatory, organizational, and institutional hurdles can delay trial activation, ultimately making some studies irrelevant. Additional issues during trial conduct (e.g., mandatory in-person visits, central confirmation of standard biomarkers, and inflexible drug dosage modification) contribute to making trials non-patient-centric. These real-life observations from experienced clinical trialists can seem nonsensical to investigators and patients alike, who are trying to bring effective drugs to patients with cancer. In this review, we delve into these issues in detail, and discuss potential solutions to make clinical trials more accessible to patients.

A Podcast on Practical Considerations in Patients with Advanced Urothelial Cancer Receiving First-Line Cisplatin- or Carboplatin-Based Chemotherapy Followed by Avelumab Maintenance in a Changing Therapeutic Landscape.

Platinum-based chemotherapy has been the cornerstone of first-line treatment for advanced urothelial carcinoma for decades, based on its proven efficacy and well-characterized safety profile. Although enfortumab vedotin (EV) plus pembrolizumab showed superior efficacy versus platinum-based chemotherapy in the EV-302 phase 3 trial, common and potentially cumulative toxicities associated with EV plus pembrolizumab may make this combination less suitable for some patients, such as those with pre-existing neuropathy, hyperglycemia, or hepatic impairment, or patients likely to have favorable outcomes with platinum-based chemotherapy. The availability of EV plus pembrolizumab in various countries may also be limited by financial considerations. Thus, platinum-based chemotherapy is likely to remain a valuable option for advanced urothelial carcinoma. Eligibility for cisplatin- or carboplatin-based regimens can be determined by assessing renal function, performance status, and specific comorbidities. In cisplatin-eligible and -ineligible patients without disease progression following platinum-based chemotherapy, avelumab first-line maintenance is standard of care based on findings from the JAVELIN Bladder 100 phase 3 trial, which showed that avelumab first-line maintenance plus best supportive care prolonged overall survival and progression-free survival compared with best supportive care alone across clinically relevant subgroups. Adverse events associated with avelumab were generally consistent with those observed with other immune checkpoint inhibitors, and long-term follow-up showed no new safety concerns with prolonged treatment. Efficacy benefits and safety profiles were similar in patients who received avelumab first-line maintenance after cisplatin- or carboplatin-based chemotherapy. The effectiveness and safety of avelumab first-line maintenance have been confirmed in several real-world studies. Overall, these data support the use of avelumab first-line maintenance for all platinum-treated patients without disease progression. In this podcast, we discuss the evolving role of platinum-based chemotherapy in this disease setting in the context of EV-302 trial results and describe practical considerations in patients receiving first-line cisplatin- or carboplatin-based chemotherapy followed by avelumab maintenance therapy.

Optimizing Clinical Trial Eligibility Design Using Natural Language Processing Models and Real-World Data: Algorithm Development and Validation.

BACKGROUND: Clinical trials are vital for developing new therapies but can also delay drug development. Efficient trial data management, optimized trial protocol, and accurate patient identification are critical for reducing trial timelines. Natural language processing (NLP) has the potential to achieve these objectives. OBJECTIVE: This study aims to assess the feasibility of using data-driven approaches to optimize clinical trial protocol design and identify eligible patients. This involves creating a comprehensive eligibility criteria knowledge base integrated within electronic health records using deep learning-based NLP techniques. METHODS: We obtained data of 3281 industry-sponsored phase 2 or 3 interventional clinical trials recruiting patients with non-small cell lung cancer, prostate cancer, breast cancer, multiple myeloma, ulcerative colitis, and Crohn disease from ClinicalTrials.gov, spanning the period between 2013 and 2020. A customized bidirectional long short-term memory- and conditional random field-based NLP pipeline was used to extract all eligibility criteria attributes and convert hypernym concepts into computable hyponyms along with their corresponding values. To illustrate the simulation of clinical trial design for optimization purposes, we selected a subset of patients with non-small cell lung cancer (n=2775), curated from the Mount Sinai Health System, as a pilot study. RESULTS: We manually annotated the clinical trial eligibility corpus (485/3281, 14.78% trials) and constructed an eligibility criteria-specific ontology. Our customized NLP pipeline, developed based on the eligibility criteria-specific ontology that we created through manual annotation, achieved high precision (0.91, range 0.67-1.00) and recall (0.79, range 0.50-1) scores, as well as a high F1-score (0.83, range 0.67-1), enabling the efficient extraction of granular criteria entities and relevant attributes from 3281 clinical trials. A standardized eligibility criteria knowledge base, compatible with electronic health records, was developed by transforming hypernym concepts into machine-interpretable hyponyms along with their corresponding values. In addition, an interface prototype demonstrated the practicality of leveraging real-world data for optimizing clinical trial protocols and identifying eligible patients. CONCLUSIONS: Our customized NLP pipeline successfully generated a standardized eligibility criteria knowledge base by transforming hypernym criteria into machine-readable hyponyms along with their corresponding values. A prototype interface integrating real-world patient information allows us to assess the impact of each eligibility criterion on the number of patients eligible for the trial. Leveraging NLP and real-world data in a data-driven approach holds promise for streamlining the overall clinical trial process, optimizing processes, and improving efficiency in patient identification.

Eligibility of Asian and European registry patients for phase III trials in heart failure with reduced ejection fraction.

AIMS: Traditional approaches to designing clinical trials for heart failure (HF) have historically relied on expertise and past practices. However, the evolving landscape of healthcare, marked by the advent of novel data science applications and increased data availability, offers a compelling opportunity to transition towards a data-driven paradigm in trial design. This research aims to evaluate the scope and determinants of disparities between clinical trials and registries by leveraging natural language processing for the analysis of trial eligibility criteria. The findings contribute to the establishment of a robust design framework for guiding future HF trials. METHODS AND RESULTS: Interventional phase III trials registered for HF on ClinicalTrials.gov as of the end of 2021 were identified. Natural language processing was used to extract and structure the eligibility criteria for quantitative analysis. The most common criteria for HF with reduced ejection fraction (HFrEF) were applied to estimate patient eligibility as a proportion of registry patients in the ASIAN-HF (N = 4868) and BIOSTAT-CHF registries (N = 2545). Of the 375 phase III trials for HF, 163 HFrEF trials were identified. In these trials, the most frequently encountered inclusion criteria were New York Heart Association (NYHA) functional class (69%), worsening HF (23%), and natriuretic peptides (18%), whereas the most frequent comorbidity-based exclusion criteria were acute coronary syndrome (64%), renal disease (55%), and valvular heart disease (47%). On average, 20% of registry patients were eligible for HFrEF trials. Eligibility distributions did not differ (P = 0.18) between Asian [median eligibility 0.20, interquartile range (IQR) 0.08-0.43] and European registry populations (median 0.17, IQR 0.06-0.39). With time, HFrEF trials became more restrictive, where patient eligibility declined from 0.40 in 1985-2005 to 0.19 in 2016-2022 (P = 0.03). When frequency among trials is taken into consideration, the eligibility criteria that were most restrictive were prior myocardial infarction, NYHA class, age, and prior HF hospitalization. CONCLUSIONS: Based on 14 trial criteria, only one-fifth of registry patients were eligible for phase III HFrEF trials. Overall eligibility rates did not differ between the Asian and European patient cohorts.

Assessing the efficiency of eligibility criteria for low-dose computed tomography lung screening in China according to current guidelines.

BACKGROUND: Evidence from observational studies indicates that lung cancer screening (LCS) guidelines with high rates of lung cancer (LC) underdiagnosis, and although current screening guidelines have been updated and eligibility criteria for screening have been expanded, there are no studies comparing the efficiency of LCS guidelines in Chinese population. METHODS: Between 2005 and 2022, 31,394 asymptomatic individuals were screened using low-dose computed tomography (LDCT) at our institution. Demographic data and relevant LC risk factors were collected. The efficiency of the LCS for each guideline criteria was expressed as the efficiency ratio (ER). The inclusion rates, eligibility rates, LC detection rates, and ER based on the different eligibility criteria of the four guidelines were comparatively analyzed. The four guidelines were as follows: China guideline for the screening and early detection of lung cancer (CGSL), the National Comprehensive Cancer Network (NCCN), the United States Preventive Services Task Force (USPSTF), and International Early Lung Cancer Action Program (I-ELCAP). RESULTS: Of 31,394 participants, 298 (155 women, 143 men) were diagnosed with LC. For CGSL, NCCN, USPSTF, and I-ELCAP guidelines, the eligibility rates for guidelines were 13.92%, 6.97%, 6.81%, and 53.46%; ERe for eligibility criteria were 1.46%, 1.64%, 1.51%, and 1.13%, respectively; and for the inclusion rates, they were 19.0%, 9.5%, 9.3%, and 73.0%, respectively. LCs which met the screening criteria of CGSL, NCCN, USPSTF, and I-ELCAP guidelines were 29.2%, 16.4%, 14.8%, and 86.6%, respectively. The age and smoking criteria for CGSL were stricter, hence resulting in lower rates of LC meeting the screening criteria. The CGSL, NCCN, and USPSTF guidelines showed the highest underdiagnosis in the 45-49 age group (17.4%), while the I-ELCAP guideline displayed the highest missed diagnosis rate (3.0%) in the 35-39 age group. Males and females significantly differed in eligibility based on the criteria of the four guidelines (P < 0.001). CONCLUSIONS: The I-ELCAP guideline has the highest eligibility rate for both males and females. But its actual efficiency ratio for those deemed eligible by the guideline was the lowest. Whereas the NCCN guideline has the highest ERe value for those deemed eligible by the guideline.

Web-Based Tool Designed to Encourage Supplemental Nutrition Assistance Program Use in Urban College Students: Usability Testing Study.

BACKGROUND: Food insecurity continues to be a risk for college students in the United States. It is associated with numerous problems, such as chronic health conditions, increased stress and anxiety, and a lower grade point average. After COVID-19, the Supplemental Nutrition Assistance Program (SNAP) benefits were extended to college-aged students; however, there were some barriers to participation, which persisted such as lack of perceived food insecurity risk, lack of knowledge regarding the SNAP application process, the complexity of determining eligibility, and stigma associated with needing social assistance. A technology-enhanced tool was developed to address these barriers to SNAP enrollment and encourage at-risk college students to apply for SNAP. OBJECTIVE: The purpose of this study was to test the usability and acceptability of a web-based SNAP screening tool designed for college-aged students. METHODS: College students aged 18-25 years were recruited to participate in 2 rounds of usability testing during fall 2022. Participants tested the prototype of a web-based SNAP screener tool using a standardized think-aloud method. The usability and acceptability of the tool were assessed using a semistructured interview and a 10-item validated System Usability Scale questionnaire. Audio recordings and field notes were systematically reviewed by extracting and sorting feedback as positive or negative comments. System Usability Scale questionnaire data were analyzed using the Wilcoxon signed rank test and sign test. RESULTS: A total of 12 students (mean age 21.8, SD 2.8 years; n=6, 50% undergraduate; n=11, 92% female; n=7, 58% Hispanic or Black or African American; n=9, 78% low or very low food security) participated in both rounds of user testing. Round 1 testing highlighted overall positive experiences with the tool, with most participants (10/12) stating that the website fulfills its primary objective as a support tool to encourage college students to apply for SNAP. However, issues related to user interface design, navigation, and wording of some questions in the screening tool were noted. Key changes after round 1 reflected these concerns, including improved design of response buttons and tool logo and improved clarity of screening questions. The overall system usability showed slight, but not statistically significant, improvement between round 1 and round 2 (91.25 vs 92.50; P=.10, respectively). CONCLUSIONS: Overall usability findings suggest that this web-based tool was highly usable and acceptable to urban college students and could be an effective and appealing approach as a support tool to introduce college students to the SNAP application process. The findings from this study will inform further development of the tool, which could eventually be disseminated publicly among various college campuses.

Focus on Trabectedin in Ovarian Cancer: What Do We Still Need to Know?

In the era of single and combination maintenance therapies as well as platinum and Poly (ADP-ribose) polymerase inhibitors (PARPi) resistance, the choice of subsequent treatments following first-line platinum-based chemotherapy in recurrent ovarian cancer (ROC) patients has become increasingly complex. Within the ovarian cancer treatment algorithm, particularly in the emerging context of PARPi resistance, the role of trabectedin, in combination with pegylated liposomal doxorubicin (PLD) still preserves its significance. This paper offers valuable insights into the multifaceted role and mechanism of action of trabectedin in ROC. The main results of clinical trials and studies involving trabectedin/PLD, along with hints of Breast Cancer genes (BRCA)-mutated and BRCAness phenotype cases, are critically discussed. Moreover, this review provides and contextualizes potential scenarios of administering trabectedin in combination with PLD in ROC, according to established guidelines and beyond.

Hematopoietic stem cell transplantation: an Italian monocentric experience on the health assessment and eligibility of adult-related donors.

Introduction: Indications for HSCT are increasing worldwide, paralleled by a growing demand for donors of therapeutic cells. Methods: Herein, we report our real-world experience of adult HPC donor assessment during a 5-year study period (2018-2023): we have retrospectively revised data of 455 potential related stem cell donors, consecutively evaluated at our center. Donor medical history was assessed by a questionnaire and an interview with a trained physician experienced in donation procedures to evaluate donor fitness and medical history. Pre-existing health disorders were fully investigated. Behavioral risk factors for communicable infectious diseases were also routinely explored. Results and discussion: Overall, 351 donors were finally assessed as eligible for HPC donation, and 233 underwent stem cell collection, 158 through apheresis from mobilized peripheral blood, and 75 through bone marrow harvest. Among them, 27 donors were selected despite the presence of pre-existing health conditions, which would be potential exclusion criteria for unrelated donors: 16 suffered from well-controlled cardiovascular diseases (CVD) and 11 from allergic diathesis. Most of the selected donors with pre-existing disorders were candidates for apheresis HPC collection (21, 77.8%), while only six (22.2%) underwent BM harvest. We then analyzed the data relative to the corresponding 233 allogeneic HSCT to explore if the presence of pre-existing diseases in the donors could show any association with transplant characteristics. Transplants from CVD and allergy donors showed no significant disparities in comparison with those from healthy donors. A significant difference emerged regarding the disease severity, with a higher proportion of patients with high/very high disease risk index (DRI) among those receiving grafts from CVD donors (68.7% in transplants from CVD donors versus 36.0% in transplants from healthy donors, p=0.005). Multivariate analysis confirmed that high/very high DRI patients had an increased probability of receiving donations from CVD donors (OR, 4.89; 95%CI, 1.15-20.86; p=0.031). Among donors with well-controlled pre-existing conditions, no adverse events were recorded during stem cell collection or at follow-up. Our results suggest that in patients at high risk for relapse requiring a prompt allogeneic transplant, a familiar donor might be accepted for HPC apheresis donation on less strict criteria than unrelated donors, without risk for both donor and patient.

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.

Among Medicare beneficiaries, Affordable Care Act coverage expansions reduced utilization of ambulatory care, particularly among duals.

We leveraged local area variation in the size of the Affordable Care Act (ACA) expansions of Medicaid and nongroup coverage and measured changes in Medicare utilization and spending from 2010 through 2018 using the universe of Medicare fee-for-service claims. We found that the ACA coverage expansions led to decreases in the share of Medicare beneficiaries receiving ambulatory care and decreases in spending per beneficiary on ambulatory care. The reductions in ambulatory care were larger among beneficiaries enrolled in both Medicare and Medicaid ("duals"). Our results suggest that coverage expansions may lead to congestion and reduced access to physicians for those who are continuously insured.

The American Association of Tissue Banks tissue donor screening for Mycobacterium tuberculosis-Recommended criteria and literature review.

After two multistate outbreaks of allograft tissue-transmitted tuberculosis (TB) due to viable bone, evidence-based donor screening criteria were developed to decrease the risk of transmission to recipients. Exclusionary criteria, commentary, and references supporting the criteria are provided, based on literature search and expert opinion. Both exposure and reactivation risk factors were considered, either for absolute exclusion or for exclusion in combination with multiple risk factors. A criteria subset was devised for tissues containing viable cells. Risk factors for consideration included exposure (e.g., geographic birth and residence, travel, homelessness, incarceration, healthcare, and workplace) and reactivation (e.g., kidney disease, liver disease, history of transplantation, immunosuppressive medications, and age). Additional donor considerations include the possibility of sepsis and chronic illness. Donor screening criteria represent minimal criteria for exclusion and do not completely exclude all possible donor TB risks. Additional measures to reduce transmission risk, such as donor and product testing, are discussed but not included in the recommendations. Careful donor evaluation is critical to tissue safety.

Why Some Nonelderly Adult Medicaid Enrollees Appear Ineligible Based on Their Annual Income.

CONTEXT: Recent studies have highlighted Medicaid enrollment among middle- and higher-income populations and questioned whether the program is reaching those for whom it is intended. METHODS: Medicaid enrollment and income in 2017 are measured using administrative tax data, monthly income is measured using survey data, and Medicaid enrollment pathways are identified in administrative data. FINDINGS: Among 38.8 million nonelderly adults in Medicaid at any point in 2017, 24.4 million had annual income below their state's typical eligibility threshold, and 14.4 million (37%) had income above the threshold. Among those above the threshold, 3.5 million enrolled through a pathway allowing higher income (pregnant women, the "medically needy", and others); we also estimate that over 12 million had at least one month with income below the threshold and roughly 4 million had at least five months with income below the eligibility threshold. CONCLUSION: Pathways allowing higher income account for one-quarter of enrollees with annual incomes above typical thresholds. Among low-income adults, month-to-month variation in income is common and can account for most or all of the remaining enrollees with annual incomes above typical thresholds. A complete accounting of eligibility status would require merged data on income, Medicaid enrollment, and family structure.

Outpatient vs. inpatient total shoulder arthroplasty: complication rates, clinical outcomes, and eligibility parameters.

Background: Improvements in total shoulder arthroplasty (TSA), fast-track surgery, multimodal anesthesia, and rehabilitation protocols have opened up the possibility of outpatient care that is now routinely practiced at our European institution. The first objective of this study was to define the TSA outpatient population and to verify that outpatient management of TSA does not increase the risk of complications. The second objective was to determine patient eligibility parameters and the third was to compare functional outcomes and identify influencing factors. Methods: The study included 165 patients who had primary TSA (106 outpatient and 59 inpatient procedures). The operative technique was the same for both groups. Demographics, complications, readmissions, and revisions were collected. American Society of Anesthesiologists, Constant, American Shoulder and Elbow Surgeons, University of California Los Angeles shoulder, and Shoulder Pain and Disability Index scores were obtained preoperatively and at 1.5, 6, and 12 months postoperatively. Satisfaction and visual analog scale pain scores also were documented. Statistical analysis was completed using multivariate linear regression. Results: Outpatients were significantly younger and had lower American Society of Anesthesiologists scores than inpatients. The rates of complications, readmissions, and reoperations were not significantly different between groups. Outpatient surgery was not an independent risk factor for complications. At 1.5 months, better outcomes were noted in the outpatient group for all scores, and these reached statistical significance. Distance to home, dominant side, operative time, and blood loss were not associated with functional results. Multivariate analysis demonstrated that outpatient care was significantly associated with improved scores at 1.5 months and did not affect functional outcomes at 6 and 12 months. Conclusion: This study reports the results of routine outpatient TSA within a European healthcare system. TSA performed in an outpatient setting was not an independent risk factor for complications and seemed to be an independent factor in improving early functional results.