Enrollment Criteria Research Articles

The Prognostic Value of Single and Repeated ≥10% FEV1 Declines for Chronic Lung Allograft Dysfunction

There is a paucity of data reporting the positive and negative predictive values (PPV, NPV) of acute declines in lung function on chronic lung allograft dysfunction (CLAD). We sought to define the predictive ability of single or repeated FEV1 declines for at least 3 weeks on the development of CLAD or death by 1-year. We analyzed 340 subjects with at least 3 years of follow-up data from two lung transplant centers. A single ≥10% FEV1 decline had a PPV of 35% and NPV of 63%, and a repeated ≥10% FEV1 decline for at least 3 weeks had a PPV of 44% and NPV of 65%. Notably, the proportion of individuals with incipient CLAD at the time of a single or repeated ≥20% FEV1 decline was 50% and 71%, respectively. These estimates could inform the development of acute lung allograft dysfunction FEV1 thresholds as enrollment criteria or surrogate outcome measures.

Discrepancies between home blood pressure and ambulatory blood pressure monitoring in apparent treatment-resistant hypertension: analysis from the Korean resistant hypertension cohort.

This study aimed to investigate the characteristics of out-of-office blood pressure (BP) measurements in patients with apparent treatment-resistant hypertension (aRH) enrolled from 15 tertiary care centers in South Korea. aRH was defined as having uncontrolled office BP ≥ 130/80 mmHg despite receiving three classes of antihypertensive medication or any level of BP despite receiving ≥4 classes of antihypertensive medication. Patients with complete data for office BP, 24-h ambulatory BP monitoring (ABPM), and home BP measurements at baseline were included. BP control status between ABPM and home BP measurements was compared. Out of 1457 patients, 823 meeting the enrollment criteria were included (mean age: 59.9 ± 13.6 years; 57.5% male patients). Among them, 7.2% had controlled BP, 8.7% had whitecoat uncontrolled hypertension, 15.1% had masked uncontrolled hypertension, and 69% had sustained hypertension, as measured through baseline ABPM. Additionally, 43% of patients with controlled BP based on home BP measurement had nocturnal hypertension. Relying solely on home BP measurement may result in misclassifying 70% of patients as having either controlled BP or whitecoat uncontrolled BP. This study reaffirms the circadian pattern of resistant hypertension, characterized by a higher prevalence of non-dipping and rising patterns, even in patients with BP controlled based on ABPM. Considering the persistent difference between home BP measurement and ABPM, even at a lower home BP threshold, integrating both measurements into the management of aRH is advisable.

Abstract 4125667: National Estimates of Patient Eligibility for Renal Denervation Therapy Post-FDA Approval

Background: Renal denervation (RDN) has been shown in randomized trials to improve blood pressure compared with a sham procedure. Currently, there are two FDA-approved RDN devices in the United States (US). While nearly half of the US population has hypertension (HTN), the number of patients who may benefit from RDN therapy remains uncertain. In this study, we used a nationally representative dataset to approximate the proportion of patients with HTN who may be eligible for consideration of RDN based on selective criteria. Methods: All adult patients with HTN who participated in the National Health and Nutrition Examination Survey (NHANES) between the years 2009-2020 were identified. We characterized the proportion of these participants that met eligibility criteria based on 1) the FDA indication, 2) the SCAI 2023 RDN position statement, and 3) enrollment criteria from the RDN on-medication randomized trials. National estimates were obtained utilizing survey weighting from the NHANES multistage probability survey design. Results: In total, we identified 16,677 patients with HTN in the US, representing a weighted total of 113,786,149 patients ( Table ). Using the FDA indication, 31.6% (95% CI, 30.7%-32.6%) of patients meet eligibility criteria for RDN, corresponding to 35,988,870 US adults. By the SCAI 2023 position statement selection criteria, 21.5% (95% CI, 20.7%-22.3%) of patients are eligible for consideration of RDN. Based on enrollment criteria from the RDN on-medication randomized trials, 2.05% (95% CI, 1.81%-2.33%) of US adults meet eligibility for consideration of RDN ( Figure ). Conclusions: Our findings indicate that nearly one third of US adults with HTN are eligible for consideration of RDN based on the FDA indication; however, a smaller proportion of patients would be eligible based upon society recommendations and randomized trial inclusion criteria. Future studies are needed to further inform which patients will best benefit from this intervention.

Asian birth cohort studies on allergic diseases: The A2BC network initiative.

The Asia Allergy Birth Cohort (A2BC) network consolidates data from multiple independently established birth cohorts across Asia to enhance research on host-environment interactions in allergic diseases. These cohorts, established at different times with various methodologies, are reliable data sources. Our aim is to introduce the content, variables, and outcomes of these cohorts while highlighting their differences, laying the groundwork for future collaborative research. The A2BC network includes 10 cohort studies on allergic diseases from six Asian countries. Enrollment criteria, study aims, and an initial inventory were discussed and confirmed through five business meetings. A common database was developed to assess the study characteristics of these observational cohorts on allergic diseases, though harmonization efforts are retrospective. Five studies collected data on specific immunoglobulin E responses to various inhalant and food allergens, while six cohorts conducted skin prick tests. Lung function measurements were included in some studies, but without standardized procedures across cohorts. Asthma and allergic rhinitis were primarily assessed using questionnaires or doctor diagnoses, while assessments of eczema and food allergies varied across studies. The A2BC network also examines early-life environmental factors such as delivery mode, antibiotic usage, diet, and air pollutants, although these exposures were measured differently across the cohorts. Despite differences in the origins, methods, and objectives of each cohort, pooling data and conducting joint analyses offer valuable insights into the relationship between environmental exposures and allergic disease outcomes in Asian children. This approach can serve as a foundation for future collaborative research.

Regression to the mean for physical function and quality of life in clinical trials for symptomatic knee osteoarthritis

ObjectiveTo estimate size of regression to the mean (RTM) for common patient-reported outcomes in trials for knee osteoarthritis (OA). DesignLongitudinal cohort study; we included participants of the Osteoarthritis Initiative who fulfilled typical inclusion criteria for enrolment in a trial. These included: age 40-79 years, symptomatic knee OA, Kellgren-Lawrence grade 2-3, use of pain medication more than half the days of a month in past 12 months, numerical rating scale pain of 4 to 9. We studied observed changes in WOMAC physical function and KOOS quality of life (QOL). ResultsWe identified 547 subjects who fulfilled inclusion criteria on at least one annual follow-up between year 1 and year 8. The mean level of physical function and QOL at each follow-up time point was similar, about 18, and about 51, respectively. However, at the time of theoretical inclusion in a trial, the mean levels in the same subjects were 23 and 43, respectively (both worse scores). The mean improvement in physical function between inclusion and 1 and 2 years later, respectively, was 2.5 (95% confidence interval 1.7 to 3.2) and 3.1 (2.3 to 3.8). The corresponding improvement in QOL was 2.7 (1.7 to 3.7) and 4.2 (3.1 to 5.3). ConclusionRTM in trials for knee OA is likely to explain improvement in physical function and QOL, not only in knee pain. RTM often misleads investigators to overinterpret effectiveness as RTM neither represents improvement from the intervention nor placebo effect from the intervention and its context.

Predicting sinonasal inverted papilloma attachment using machine learning: Current lessons and future directions

BackgroundHyperostosis is a common radiographic feature of inverted papilloma (IP) tumor origin on computed tomography (CT). Herein, we developed a machine learning (ML) model capable of analyzing CT images and identifying IP attachment sites. MethodsA retrospective review of patients treated for IP at our institution was performed. The tumor attachment site was manually segmented on CT scans by the operating surgeon. We used a nnU-Net model, a state-of-the-art deep learning-based segmentation algorithm that automatically configures image preprocessing, network architecture, training, and post-processing to identify the IP attachment site. The model was trained and evaluated using a 5-fold cross validation, where each iteration split the data into train/validation/test to avoid chances of overfitting. The attachment site was classified as either ‘identified or ‘not identified’ using the nnU-Net model output and the Sørensen–Dice coefficient (Dice) was used to further evaluate the segmentation performance of each subject. ResultsA total of 58 subjects met enrollment criteria. The algorithm identified the attachment site in 55.2 % (n = 32) of patients with an average dice score (+/-SD) of 0.34 (+/− 0.24). In the univariate analysis, the algorithm performed better for attachment sites within the maxillary sinus (OR 4.0; p < 0.05) and performed worse during revision surgery (OR 0.13; p < 0.05). Multivariate logistic regression analysis confirmed these associations for maxillary attachment site (OR 4.6; p < 0.05) and revision surgery (OR 0.11; p < 0.05). ConclusionA state-of-the-art ML model successfully identified the attachment site of IP with a high degree of fidelity in select cases, but requires larger sample sizes and more diverse datasets to become reliably integrated into clinical practice.

Applicability of VICTORION-1 PREVENT Criteria to the US Population

Abstract Background VICTORION-1 PREVENT (V-1P) is an ongoing randomized clinical trial comparing inclisiran sodium 300mg every six months with placebo for primary prevention in patients with high cardiovascular (CV) risk. Purpose We evaluated the generalizability of V-1P trial enrollment criteria to the US population to understand the demographic and CV health characteristics of the trial target population. Methods We included data from the National Health and Nutrition Examination Survey (N=25,531, 2015-March 2020), a nationally representative sample of the US population. Enrollment criteria similar to V-1P were applied. Nonpregnant adults 40-79 years with low-density lipoprotein cholesterol (LDL-C) of 70-189 mg/dL were included. 10-year risk for CV disease was determined using the American Heart Association race-free 10-year PREVENT risk equations. Individuals with 10-year risk &amp;gt;20% or 7.5%-19.9% with two risk enhancing factors at baseline were included. Risk enhancing factors included elevated high sensitivity C-reactive protein (≥2 mg/L), inflammatory arthritis, estimated glomerular filtration rate &amp;lt;60 ml/min/1.73 m2, metabolic syndrome, or early family history of CV disease. Patients with history of atherosclerotic CV disease or liver disease were excluded. Estimates of demographics and health characteristics were nationally representative using survey weights. Results Among US adults, 21,576,506 (standard error [SE]: ±1,258,255) meet eligibility criteria for V-1P (weighted estimate). This represents 8.8% of all US adults or 15.1% of US adults 30-79 years. The V-1P eligible population had a mean age of 65.3 years (SE: ±0.5 years), and 55.0% (SE: ±2.5%) were female. Compared with the US adult population (≥18 years), V-1P eligible population had a higher mean body mass index (32.6 ± 0.3 kg/m2 vs 29.5 ± 0.2 kg/m2) and higher rates of obesity (61.0% ± 2.1% vs 40.0% ± 1.1%) (Table). V-1P eligible population also had higher mean systolic blood pressure (133.9 ± 1.0 mmHg vs 121.7 ± 0.3 mmHg), similar mean diastolic blood pressure (72.6 ± 0.8 mmHg vs 71.8 ± 0.2 mmHg), and higher rates of hypertension (85.8% ± 2.0% vs 45.9% ± 1.1%). Mean hemoglobin A1c percent (6.3 ± 0.1 vs 5.7 ± 0.02), fasting blood sugar (127.7 ± 1.9 mg/dL vs 109.2 ± 0.6 mg/dL), and diabetes rates (39.7% ± 2.6% vs 13.1% ± 0.7%) were higher in the V-1P eligible population. Mean low-density lipoprotein cholesterol (115.8 ± 1.5 mg/dL vs 110.2 ± 0.8 mg/dL) and fasting triglycerides (137.6 ± 5.0 mg/dL vs 110.4 ± 1.7 mg/dL) were higher, while mean high-density lipoprotein cholesterol was lower (49.9 ± 0.8 mg/dL vs 54.8 ± 0.4 mg/dL). The distribution of key CV risk factors is shown in the Figure. Conclusion V-1P enrollment criteria apply to many patients. These patients have significant cardiometabolic risk factor burden, and effective preventive therapies could have substantial health impact.

Empagliflozin's role in reducing ventricular repolarization heterogeneity: insights into cardiovascular mortality decline from the EMPATHY-HEART trial

Abstract Introduction The incidence of myocardial infarction (MI) and sudden cardiac death (SCD) is significantly higher in individuals with Type 2 Diabetes Mellitus (T2DM). Predictive measures for fatal arrhythmias are often inadequate, highlighting the need for novel non-invasive diagnostic tools. The T-wave heterogeneity (TWH) index, which measures variations in ventricular repolarization, has emerged as a promising predictor for severe ventricular arrhythmias. Although the EMPA-REG trial reported reduced cardiovascular mortality with empagliflozin, the underlying mechanisms remain unclear. This study investigates the potential of empagliflozin in mitigating electrical instability in patients with T2DM and coronary heart disease (CHD) by examining changes in TWH. Methods Participants were adult outpatients with T2DM and CHD, exhibiting a baseline TWH of at least 80 µV. They received a 25mg daily dose of empagliflozin and were evaluated clinically, including ECG measurements at baseline and after 4 weeks. TWH was computed from leads V4, V5, and V6 using a validated technique. The primary study outcome was the alteration in TWH following empagliflozin administration, assessed via the Wilcoxon test, with a significance threshold of p&amp;lt;0.05. Results An initial review of 6,000 medical records pinpointed 800 patients for TWH evaluation. Of these, 412 exhibited TWH above 80 µV, with 144 completing clinical assessments and 90 meeting the criteria for high cardiovascular risk enrollment. Empagliflozin adherence exceeded 80%, resulting in notable reductions in blood pressure without affecting heart rate. Side effects were generally mild, with 13.3% experiencing mostly Level 1 hypoglycemia, alongside infrequent urinary and genital infections. The treatment consistently reduced median TWH from 116 to 103 µV (p=0.01), as detailed in Figure 1. Conclusion The EMPATHY-HEART trial preliminarily suggests that empagliflozin decreases heterogeneity in ventricular repolarization among patients with T2DM and CHD. This reduction in TWH may provide insight into the mechanism behind the decreased cardiovascular mortality observed in previous trials, potentially offering a therapeutic pathway to mitigate the risk of severe arrhythmias in this population.Table 1 Figure 1

Lack of incremental prognostic value of triglyceride glucose index beyond coronary computed tomography angiography features for major events

This study was aim to determine the prognostic value of triglyceride-glucose (TyG) index and coronary computed tomography angiography (CTA) features for major adverse cardiovascular events (MACE). In addition, we investigate the incremental prognostic value of TyG index beyond coronary CTA features in patients with suspected or known coronary artery disease (CAD). The present study ultimately includes 3528 patients who met the enrollment criteria. The TyG index was calculated based on measured levels of triglycerides and fasting blood glucose. Primary combined endpoint consisted of MACE, which defined as myocardial infraction (MI), all-cause mortality and stroke. Three multivariate Cox proportional hazard regression models were performed to assess the association between TyG index and MACE. C-statistic was performed to assess the discriminatory value of models. 212 (6.0%) patients developed MACE during a median follow-up of 50.4 months (IQR, 39.4–55.1). TyG index remained to be a significantly and independent risk factors for predicting MACE after adjusting by different models (clinical variables alone or plus coronary CTA features) in multivariable analysis. Both the addition of TyG index to clinical model plus Coronary Artery Disease Reporting and Data System (CAD-RADS) and to clinical model plus CAD-RADS 2.0 slightly but not significantly increased the C-statistic index (0.725 vs. 0.721, p = 0.223; 0.733 vs. 0.731, p = 0.505). TyG index was associated with an increased risk of MACE. However, no incremental prognostic benefit of TyG index over CAD-RADS or CAD-RADS 2.0 was detected for MACE in patients with suspected or known CAD.

Clonidine as Monotherapy for Neonatal Opioid Withdrawal Syndrome: A Randomized Trial.

We sought to determine whether clonidine, a non-opioid α-2-adrenergic agonist, would effectively treat neonatal opioid withdrawal syndrome (NOWS). This was an intention-to-treat randomized clinical trial. Enrollment criteria included prenatal opioid exposure, age ≤7 days, gestational age ≥35 weeks, no other medical condition, and need for pharmacotherapy. Primary outcomes were length of treatment and neurobehavioral performance. A total of 1107 patients were screened for enrollment (645 ineligible, 91 parents or staff unavailable, 216 declined, 155 consented). Of 155 infants, 120 required treatment and were randomized to receive oral clonidine (n = 60) at 1 µg/kg/dose or morphine (n = 60), 0.06 mg/kg/dose, every 3 hours. Infants with no improvement had their doses increased by 25% of the initial dose every 12 to 24 hours. Those without improvement by the fourth dose increase, received adjunct therapy. Length of treatment did not differ between morphine and clonidine, with median (95% confidence interval [CI]) days, respectively, of 15 (13-17) and 17 (15-19), P = .48. More clonidine-treated infants (45%) needed adjunct therapy versus 10% in the morphine group, adjusted odds ratio (95% CI) = 8.85 (2.87-27.31). After treatment completion, the NICU Network Neurobehavioral Scales summary scores did not differ between clonidine-treated and morphine-treated infants. Length of pharmacologic treatment and final neurobehavioral performance were not significantly different between the clonidine- and morphine-treated groups. Clonidine appears to be an effective non-opioid medication to treat NOWS. Future studies are needed to determine the optimal clonidine dosage for a quicker response and obviation of adjunct therapy.

Survival After Extracorporeal Cardiopulmonary Resuscitation Based on In-Hospital Cardiac Arrest and Cannulation Location: An Analysis of the Extracorporeal Life Support Organization Registry.

Explore whether extracorporeal cardiopulmonary resuscitation (ECPR) mortality differs by in-hospital cardiac arrest location and whether moving patients for cannulation impacts outcome. Retrospective cohort study. ECPR hospitals that report data to the Extracorporeal Life Support Organization (ELSO). Patients having ECPR for in-hospital cardiac arrest between 2020 and 2023 with data in the ELSO registry. None. Patient demographics, comorbidities, pre-cardiac arrest conditions, pre-ECPR vasopressor use, cardiac arrest details, ECPR cannulation information, major complications, and in-hospital mortality were recorded. Multivariable logistic regression model was used to examine the associations between in-hospital mortality and 1) cardiac arrest location and 2) moving a patient for ECPR cannulation. A total of 2515 patients met enrollment criteria. The adjusted odds ratio (aOR) for mortality was increased in patients who had a cardiac arrest in the ICU (aOR, 1.85; 95% CI, 1.45-2.38; p < 0.001) and in patients who had a cardiac arrest in an acute care bed (aOR, 1.68; 95% CI, 1.09-2.58; p = 0.02) compared with the cardiac catheterization laboratory. Moving a patient for cannulation had no association with mortality (aOR, 0.70; 95% CI, 0.18-2.81; p = 0.62). Advanced patient age was associated with increased mortality. Specifically, patients 60-69 and patients 70 years old or older were more likely to die compared with patients younger than 30 years old (aOR, 1.71; 95% CI, 1.17-2.50; p = 0.006 and aOR, 2.27; 95% CI, 1.49-3.48; p < 0.001, respectively). ECPR patients who experienced cardiac arrest in the ICU and in acute care hospital beds had increased odds of mortality compared with other locations. Moving patients for ECPR cannulation was not associated with improved outcomes.

Impact of the COVID-19 Pandemic on Lifestyle Behavior and Clinical Care Pathway Management in Type 2 Diabetes: A Retrospective Cross-Sectional Study.

Background and Objectives: In Italy, as in the rest of the world, government restrictions aimed at containing the spread of COVID-19 primarily imposed limitations on social relationships and personal behavior. This situation significantly affected the management of chronic illnesses, including type 2 diabetes (T2D). The objective was to evaluate the perceptions of patients with T2D regarding the quality of care received during the COVID-19 pandemic and the impact on dietary and physical activity behaviors. Materials and Methods: We conducted a retrospective cross-sectional survey. Data were collected from June to July 2023 using the convenience sampling of patients with T2D, and the Patient Assessment of Chronic Illness Care (PACIC) and Medi-Lite questionnaires were administered. Results: During the research period, out of the 130 subjects who met all enrollment criteria, 103 patients were included in this study (79.23%). The results of the administered questionnaires were heterogeneous. The average scores from the PACIC Questionnaire for each question displayed significant variability, indicating a range of experiences in the quality of care. In the Medi-Lite survey, fruit, cereals, and olive oil showed the highest adherence levels, with mean scores ranging from 2.58 (SD ± 1.18) for fruit to 1.89 (SD ± 0.34) for olive oil and 1.97 (SD ± 0.17) for cereals. Patients who reported increased food intake during the lockdown attributed it to having more time to prepare meals. Physical activity levels remained unchanged for 48 patients, decreased for 45 patients, and only 9 patients managed to exercise more during the COVID-19 restrictions. Conclusions: Healthcare systems must prioritize comprehensive care plans for T2D that address not only physical health, but also emotional and social well-being. Post-pandemic, promoting healthier lifestyles and empowering patients to manage their condition is crucial. A multidisciplinary and multidimensional approach could support the care of vulnerable individuals, such as patients with T2D, especially during crises like pandemics or other dramatic events.

Veteran comfort and satisfaction with comprehensive geriatric assessment via video telehealth to home.

The purpose of this project was to measure satisfaction with virtual comprehensive geriatric assessments (CGA) among older Veterans (OVs). The CGA involved five different healthcare providers and four one-hour VA Video Connect (VVC) calls. Using specific enrollment criteria, OVs were recruited in four cohorts separated by time. After completing the CGA, participants were asked to complete a 10-statement telephone questionnaire. Before analyses, responses to each statement were dichotomized as Agree (Agree/Strongly agree) or Do not Agree (Neutral/Disagree/Strongly Disagree). Descriptive statistics and Binomial generalized linear models (GLMs) were used to analyze the data. All 269 enrolled OVs completed all components of the CGA. This included 79, 57, 61, and 72 Veterans in cohorts 1 to 4, respectively. Their average age was 76.0 ± 5.9 years, and they were predominately white (82%), male (94%), and residents of rural settings (64%). Of the 236 (88%) OVs who completed the telephone survey, 57% indicated they were comfortable using VVC and 57% expressed willingness to use VVC again; 44% felt that VVC was easier than going to in-person visits. The OVs in Cohort 1 were more likely to agree with these statements than those in the remaining cohorts, especially Cohorts 2 and 4. Differences in demographics partially explained some of these findings. The majority (89% or higher) of survey participants agreed with the remaining seven survey statements indicating they were satisfied with the CGA program. OVs were very satisfied with their participation in a program of CGA, although not necessarily the mode of delivery. The percentage of participants who indicated discomfort using VVC for the CGA visits appeared to increase with time. Further work is needed to determine which OVs would be the best candidates to use VVC to complete all or part of a CGA.

Association of Androgenetic Alopecia with Metabolic Syndrome.

To determine the association of androgenetic alopecia (AGA) with metabolic syndrome (MetS) in either gender. Descriptive study. Place and Duration of the Study: OPD complex, Pak Emirates Military Hospital, Rawalpindi, Pakistan, from February to August 2021. The study included a total of 90 patients who met the specified criteria for enrolment. Each group (case and control) contains 45 patients. Diagnosis of androgenetic 2 alopecia was done clinically and grading was based on the Norwood-Hamilton classification in males and Ludwig classification in females. Body mass index (BMI) was calculated and blood pressure was measured for all enrolled patients. Following an overnight fasting period, blood samples were collected from each patient to measure clinical parameters including triglycerides (TGs), fasting blood sugar (FBS), and high-density lipoprotein (HDL) levels. There were 85.6% males and 4.4% females with a mean age of 43.38 years. Out of which, 34.4% and 15.6% of patients fell in severity 1 and severity 2 Class. Patients were stratified on the basis of AGA with respect to TGs, FBS, HDL, and BMI. The p-value was significant when stratified on the basis of BMI, FBS, and HDL except TGs. Odd ratio of both groups on the basis of (MetS) 8.1. Odd ratio between androgenic alopecia and metabolic syndrome was of 2.4. An association existed between androgenetic alopecia and metabolic syndrome indicating the potential benefit of early MetS screening for individuals with androgenic alopecia. This proactive approach could help prevent unforeseen complications through timely lifestyle adjustments. Metabolic syndrome, Androgenic alopecia, Cholesterol, Triglycerides.

Targeting Community-Based Palliative and Serious Illness Care Resources: Challenges of More Stringent Diagnostic Criteria for Prospective Enrollment.

Background: For patients with serious illnesses, one aim of palliative care services is to reduce the frequency and severity of hospital-based episodes of care. Since hospital-alternative palliative care may consume costly resources, providers need to efficiently target high-intensity services toward those most at risk for such adverse episodes of care. Objective: Our objective was to investigate progressively more restrictive diagnosis-based indications of serious illness as used to prospectively identify patients with higher average rates of hospitalization. Design/Setting: We designed an observational cohort quality improvement study using historical Medicare claims records to evaluate diagnostic inclusion criteria for targeting palliative and serious illness care resources. We first isolated a Seriously Ill Population (SIP) and then defined More SIP and Most SIP subgroups. Measurements: Our primary outcome measure was the 2019 acute-care count of hospitalizations for patients in the SIP, More SIP, and Most SIP subgroups, respectively. Results: The More SIP and Most SIP subgroups exhibited higher hospitalization rates. However, they also excluded progressively more seriously ill patients who did experience hospitalizations. In addition, almost half of the Most SIP subgroup were not hospitalized at all, despite having an average hospitalization rate greater than one. Conclusion:Allocating resources (personnel and services) toward reducing hospitalizations when almost half of the targeted population never goes to the hospital could result in unnecessary expenditures and exclude patients that could potentially benefit. Engaging community-based services to detect changes in status could provide supplemental indications of when and for whom to target palliative care resources.

Insurance coverage for AYAs at cancer diagnosis: A claims-based analysis.

105 Background: Adolescents and Young Adults (AYAs), aged 15-39, experience unique challenges in cancer care. Frequent health insurance gaps for this population due to age, employment, and living changes hinder effective care and outcome assessments. Uninsured AYAs have lower survival rates, and insurance disparities are notable among Black, Hispanic, and rural patients; however, patterns of enrollment among AYAs have not been well described. Our study examined these patterns using insurance claims data to better inform AYA cancer care and outcomes. Methods: We conducted a retrospective cohort study with the Cancer Information and Population Health Resource (CIPHR), a linkage of cancer registry data and private and public payer data in North Carolina, including Medicaid and over 70% of the private insurance market. We included patients aged 15-39 diagnosed with common AYA cancers (leukemia, lymphoma, breast cancer, melanoma, sarcoma, germ cell tumors) from 2003-2019, linked to claims from 2003-2020. We analyzed insurance coverage patterns, comparing continuous enrollment 1) from two months pre-diagnosis to 12 months post-diagnosis and 2) from the month of diagnosis through 12 months. We compared demographics, clinical characteristics, and insurance types across scenarios. Results: The full cancer registry cohort included 21,060 AYAs; 11,024 (52.3%) had no link to Medicaid or private insurance in the year of cancer diagnosis. Continuous enrollment was 4,707 (22.4%) from two months prior through 12 months after, increasing to 5,912 (28.1%) for month of diagnosis through 12 months, particularly among Medicaid beneficiaries (from 10.8% to 15.6% of total cohort). Less restrictive criteria increased representation among Black (from 29.1% to 38.5%) and rural patients (from 25.2% to 33.1%) and those with leukemia (25.2% to 33.8%) and lymphoma (24.0% to 31.0%). Conclusions: AYAs face substantial hurdles with discontinuous insurance coverage around their cancer diagnosis. Claims-based research can characterize cancer care delivery, and use of less restrictive eligibility criteria expands the generalizability of findings to a more diverse cohort of AYAs. Increasing health insurance coverage over time may be due to the Affordable Care Act. Medicaid expansion within our state is likely to further improve access for AYAs. Continued efforts are essential to help AYAs with cancer secure necessary insurance coverage. Characteristics of AYAs by insurance enrollment criteria. Registry Cohort (n = 21,060) Continuous Enrollment –2 mos to 12 mos (n= 4,707) Continuous Enrollment 0 to 12 mos (n = 5,912) Cancer Type Breast 5817 1345 (23.1%) 1754 (30.2%) Sarcoma 1833 429 (23.4%) 532 (29.0%) Lymphoma 4436 1064 (24.0%) 1374 (31.0%) Leukemia 2393 604 (25.2%) 809 (33.8%) Race/Ethnicity Black 3951 1150 (29.1%) 1521 (38.5%) White 14620 3153 (21.6%) 3886 (26.6%) Hispanic 1296 164 (12.7%) 210 (16.2%) Location Urban 16277 Rural 4728 1190 (25.2%) 1565 (33.1%)

High efficacy of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in Black adults in the United States, including those with pre-existing HIV resistance and suboptimal adherence.

BRAAVE (NCT03631732), a Phase 3b, multicenter, open-label US study, demonstrated the efficacy of switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) among Black individuals with suppressed HIV through 48 weeks. Here, 72-week resistance, adherence, and virologic outcomes are presented. Enrollment criteria permitted nonnucleoside reverse transcriptase inhibitor (NNRTI)-resistance (R), protease inhibitor (PI)-R, and certain nucleos(t)ide reverse transcriptase inhibitor (NRTI)-R (M184V/I allowed; ≥3 thymidine analog mutations [TAMs] excluded); but excluded primary integrase strand transfer inhibitor (INSTI)-R. Pre-existing resistance was determined using historical genotypes and retrospective baseline proviral DNA genotyping. Adherence, virologic outcomes, and viral blips were assessed. Of 489 participants receiving B/F/TAF with ≥1 post-switch HIV-1 RNA measurement: pre-existing NRTI-R (15% of participants), M184V/I (11%), ≥1 TAMs (8%), NNRTI-R (22%), and PI-R (13%) were observed; pre-existing INSTI-R substitutions (2%) were detected post-randomization; mean viral blip frequency was 0.9% across all timepoints (unassociated with virologic failure); 24% of participants had <95% adherence (98% of whom had HIV-1 RNA<50 copies/mL at last visit); none had treatment-emergent study-drug resistance. Overall, 99% of participants, including all with baseline NRTI-R/INSTI-R, had HIV-1 RNA<50 copies/mL at the last visit, demonstrating that B/F/TAF maintained virologic suppression through 72 weeks regardless of pre-existing resistance, viral blips, and suboptimal adherence.

Effect of laterality on the postoperative survival of non-small cell lung cancer patients undergoing pneumonectomy.

Pneumonectomy is one of the important surgical methods for non-small cell lung cancer (NSCLC). This study evaluated the effects of laterality on the short- and long-term survival of NSCLC patients undergoing pneumonectomy. We reviewed the Surveillance, Epidemiology, and End Results database to retrieve the data of patients who underwent pneumonectomy for stage I-III NSCLC from 2004 to 2015. Propensity score matching (PSM) was used to reduce the selection bias. Logistic regression was used to analyze the correlation between laterality and mortality at 3, 6, and 9 months. The Kaplan-Meier curve was used to further assess the effect of laterality on overall survival (OS). A total of 4,763 patients met the enrollment criteria [right-sided, 1,988 (41.7%); left-sided, 2,775 (58.3%)]. After PSM, 1,911 patients for each side were included in the further analysis. The first 6 months following pneumonectomy was the main period of death, with 32.0% (428/1,336) and 19.9% (250/1,258) of right- and left-sided deaths occurring during this period. The logistic regression analysis showed that right-sided pneumonectomy was an independent risk factor for 3- (P<0.001) and 6-month (P<0.001) mortality. However, laterality had no significant effect on postoperative death at 7-9 months (P=0.82). In the total cohort, right-sided patients had worse OS (P<0.001), but the subgroup survival analysis of patients with a follow-up period >6 months revealed that laterality had no statistically significant effect on OS (P=0.75). Right-sided pneumonectomy was associated with a higher perioperative mortality risk that lasted about 6 months. After that period, laterality was not observed to have a significant prognostic effect on the OS of patients undergoing pneumonectomy.

Dietary counseling plus omega-3 supplementation in the treatment of generalized anxiety disorder: results of a randomized wait-list controlled pilot trial (the ‘EASe-GAD Trial’)

ABSTRACT Objectives Clinical evidence suggests that nutrition interventions can significantly improve symptoms of major depressive disorder; however, the effect on clinical anxiety symptoms in individuals with anxiety disorders has not been studied. The primary objective of the present study was to assess the feasibility and acceptability of a nutrition intervention. The secondary objectives included assessing changes in anxiety symptom severity, diet quality, self-efficacy, mindful eating, quality of life, and biomarkers. Methods This study was a randomized, wait-list controlled pilot trial delivering a 12-week, biweekly dietary counseling intervention and omega-3 supplementation to 50 adult women with generalized anxiety disorder. Questionnaires and blood work were completed at baseline, after the waiting period, and after the intervention. Results 443 individuals expressed interest within eight months; 50 met the criteria for enrollment. The mean number of sessions attended was 6.4. Final questionnaires were completed by 46 participants. Eighty-four percent of participants strongly agreed with the statement ‘My experience during this study was positive’. The mean anxiety symptom severity score in the intervention group was 26.2 (95% CI 22.94–29.48) at baseline and 11.0 (95% CI 8.05–13.87) at week 12. The mean diet quality score was 7.2 (95% CI 6.32–8.10) and 10.5 (95% CI 9.55–11.49) at baseline and week 12, respectively. Among the waitlist participants, the mean baseline anxiety score was 29.3 (95% CI 24.73–33.91) and 26.8 (95% CI 22.09–31.56) at week 12. Discussion This study was feasible and acceptable. Participation in the intervention was associated with a decrease in anxiety symptoms. These findings lay the foundation for large-scale studies. Trial registration: ClinicalTrials.gov NCT05573672.

Cost-Effectiveness of Empagliflozin in Chronic Kidney Disease with or without Albuminuria

Key Points Empagliflozin is cost-effective for the treatment of CKD in patients with an urine albumin-to-creatinine ratio of 30 mg/g or more.Empagliflozin is not cost-effective for the treatment of CKD in patients with an urine albumin-to-creatinine ratio &lt;30 mg/g. Background The Study of Heart and Kidney Protection with Empagliflozin (EMPA-KIDNEY) expanded the CKD population that may benefit from sodium-glucose cotransporter 2 inhibitors in terms of eGFR and urine albumin-to-creatinine ratio. This enables a cost-effectiveness analysis of empagliflozin in subgroups stratified by these two parameters. Methods A cost–utility analysis using the Markov model was performed to evaluate the cost-effectiveness of adding empagliflozin to the standard treatment for CKD in Japan over 20 years of observation. Each cohort with the initial eGFR (≥45 but &lt;60 ml/min per 1.73 m2, ≥30 but &lt;45 ml/min per 1.73 m2, or ≥20 but &lt;30 ml/min per 1.73 m2) and urine albumin-to-creatinine ratio (&lt;30 mg/g, ≥30 but &lt;300 mg/g, or ≥300 mg/g) within the defined ranges was analyzed. The changes in eGFR were determined on the basis of the EMPA-KIDNEY study. An incremental cost-effectiveness ratio of &lt;¥5,000,000 (approximately $35,500) per quality-adjusted life-year (QALY) was considered cost-effective. One-way deterministic analyses, probabilistic sensitivity analyses, and scenario analyses were conducted to ensure the robustness of the results. Results The addition of empagliflozin to the standard treatment was associated with lower costs and higher QALYs in the macroalbuminuria or microalbuminuria cohorts while the incremental cost-effectiveness ratios in the negative albuminuria cohorts were &gt;¥5,000,000 per QALY, regardless of the initial eGFR. The probabilities of empagliflozin being cost-effective were &gt;84% in the macroalbuminuria or microalbuminuria cohorts but &lt;30% in the negative albuminuria cohorts. Scenario analyses where empagliflozin suppressed the eGFR decline in the negative albuminuria cohorts showed that the drug was cost-effective in CKD stage G3b and G4 cohorts. Empagliflozin was not cost-effective in patients with CKD stage G3a and microalbuminuria with the observation period of 10 years. Conclusions In patients meeting the enrollment criteria for the EMPA-KIDNEY trial, the addition of empagliflozin to the standard treatment of CKD was judged as cost-effective for patients with albuminuria but not for those without albuminuria in the Japanese health care system.