Jacobs Institute of Women's Health
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Editorial: Use of artificial intelligence to improve maternal and neonatal health in low-resource settings
No full textRademikibart monotherapy for moderate-to-severe atopic dermatitis in a 1-year, randomized, phase II trial (SEASIDE CHINA): initial two-week dosing, followed by two-week or four-week dosing
No full textBACKGROUND: Rademikibart (CBP-201) is a potent, next-generation, optimized IL-4Rα-targeting antibody. OBJECTIVES: To evaluate rademikibart efficacy and safety, initially dosed every other week (Q2W), and Q2W or every fourth week (Q4W) from Week 16, in Chinese adults/adolescents with moderate-to-severe atopic dermatitis (AD). METHODS: SEASIDE CHINA (NCT05017480) was a phase II trial: Stage 1 (16-week treatment period), Stage 2 (36-week treatment and 8-week follow-up periods). The primary endpoint was the proportion of patients with a vIGA score 0/1 and ≥2-point reduction from baseline at Week 16. Overall, 330 patients were randomized (2:1) double-blind to receive subcutaneous rademikibart, 600 mg on Day 1 and 300 mg Q2W from Week 2-14, or placebo. Pre-dose at Week 16, patients were assessed for minimally important change (≥50% Eczema Area and Severity Index score reduction, EASI-50) and re-randomized (1:1) double-blind to rademikibart 300 mg Q2W or Q4W. RESULTS: In Stage 1, 29.0% of patients attained vIGA0/1 and ≥2-point reduction with rademikibart Q2W (p\u3c0.001; 5.9% with placebo) at Week 16, without plateauing. Rapid, significant improvements were also observed with all other rating scales in Stage 1, including EASI-75 (58.6% vs 22.6%) and PP-NRS ≥4-point reduction (36.3% vs 10.5%) with rademikibart Q2W vs placebo, respectively, at Week 16. In Stage 2, Week 16 EASI-50 responders from Stage 1 continued to improve through Week 52 when treated with rademikibart Q2W or Q4W, including vIGA0/1 (59.1%, 62.6%), EASI-75 (84.6%, 84.8%), and PP-NRS ≥4-point reduction (60.4%, 70.3%). Most patients with improvements during rademikibart Q2W therapy at Week 16 maintained these responses through Week 52 in both rademikibart Q2W and Q4W groups: vIGA0/1 (78.0%, 87.1%), EASI-75 (90.1%, 92.3%), PP-NRS ≥4-point reduction (85.3%, 94.8%). Injection site reactions were Grade 1 (mild). No serious TEAEs were treatment related. Three patients discontinued rademikibart due to TEAEs (AD flare, vitiligo, pregnancy). CONCLUSIONS: Rademikibart Q2W induced rapid improvements in AD lesions and pruritus during the initial 16 weeks, which were maintained/improved further with rademikibart Q2W or Q4W across an additional 36 weeks. Rademikibart Q2W and Q4W were similarly efficacious and well tolerated. These findings are compatible with those from the published WW001 international phase II rademikibart trial
Healthcare Disparities in Spine Oncology: A Systematic Review
No full textBACKGROUND: Metastatic spine tumors are the most common site of skeletal metastasis, leading to substantial morbidity from pain, fractures, and spinal cord compression. Despite advancements in surgical techniques and multidisciplinary care, disparities in treatment access and outcomes remain. This systematic review synthesizes the literature on disparities in surgical management of metastatic spine tumors. METHODS: Following PRISMA guidelines, we searched PubMed, Science Direct, and Web of Science for English-language studies published between May 2000 and May 2024. Studies included adult patients with metastatic spine tumors and evaluated disparities by race/ethnicity, insurance status, socioeconomic status (SES), or hospital-related factors. Study quality was assessed using the MINORS tool. RESULTS: Ten studies (n = 227,592) were included. Six studies identified racial disparities: Black patients were less likely to undergo surgery (OR 0.71, 95% CI 0.62-0.82, p \u3c 0.001, vs. White) and had higher odds of complications and non-home discharge. Five studies showed insurance-related disparities, with Medicaid or uninsured patients experiencing increased in-hospital mortality (up to OR 2.66, 95% CI 1.20-5.89, vs. Medicare/private). Lower SES and treatment at low-volume hospitals were associated with poorer outcomes. Notably, patients from neighborhoods with higher educational attainment had shorter hospital stays (median 9.3 vs. 12.2 days, p = 0.0058). Safety-net institutions reported minimal disparities, suggesting that equitable care models can mitigate these gaps. CONCLUSION: Persistent disparities in metastatic spine tumor care are driven by systemic and structural factors. Policy reform and equity-focused care pathways are necessary to reduce inequities and improve outcomes in spine oncology
Rehabilitation Researchers Learning Health Systems Needs Assessment Survey: An Updated Assessment of Research Competencies
No full textOBJECTIVE: To use the updated Rehabilitation Researchers Learning Health Systems (LHS) Needs Assessment Survey for conducting a needs assessment and identify current knowledge and interest in LHS competencies among rehabilitation professionals. DESIGN: The anonymous, cross-sectional online survey included 70 competency items related to LHS research core competencies across 8 domains. SETTING: The respondents were recruited through the LHS Rehabilitation Research Network partners. PARTICIPANTS: There were 637 respondents (N=637) who indicated interest and knowledge in LHS research competency items and completed at least 1 competency item or 1 demographic question. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Rehabilitation Researchers Learning Health Systems Needs Assessment Survey. RESULTS: The most common professions reported among respondents were physical therapy (24.5%), research (21.6%), and behavioral health (17.6%). The research questions and standards domain had the highest average proportion of respondents indicating a lot of interest (67.6%). The systems science domain had the highest average proportion of respondents indicating none or some knowledge (89%). Competency items that were of high interest and low knowledge were from the systems science, research methods and engagement, leadership, and research management, improvement and implementation, health and health care equity and justice, research questions and standards, and informatics domains. CONCLUSIONS: In this updated needs assessment survey of LHS competencies among the rehabilitation community, we found that there was continued high interest across LHS domains, high current interest in health and health care equity and justice domain topics, and limited knowledge related to systems science domain competency items. The results of the survey identified new directions for learning opportunities as well as areas for continued engagement to work toward achieving proficiency in LHS competencies among rehabilitation researchers
2D Speckle Tracking Strain Echocardiography in Multisystem Inflammatory Syndrome in Children: A Multicenter Analysis From the MUSIC Study
No full textBACKGROUND: 2D-speckle tracking echocardiography may help detect subclinical ventricular dysfunction, but data in multisystem inflammatory syndrome in children (MIS-C) are scarce. We investigated left ventricular (LV) strain parameters in MIS-C and their association with outcomes. METHODS: We performed an ambi-directional, 32-center cohort study on hospitalized patients with MIS-C (March 2020-November 2021) with at least 1 echocardiogram read by the Core Lab. Generalized estimating equation modeling was used to test associations between LV strain and a composite in-hospital adverse cardiovascular outcome (vasoactive support, arrhythmias, cardiac arrest, extracorporeal support, death, or heart transplant). RESULTS: Of 349 patients (median age, 8.7 years [interquartile range, 5.3-12.9]), 35% had decreased LV ejection fraction during hospitalization, and 45% had depressed LV strain (either 4-chamber LV longitudinal strain [4CH-LVLS] or mid-ventricular LV circumferential strain [mid-LVCS]). The worst 4CH-LVLS and mid-LVCS occurred at ≈5 days of illness; 50% of abnormal LV strain normalized within 1 week, and 95% within 50 days. In-hospital adverse outcomes occurred in 35% of patients; these patients were older (P=0.003) and, at admission, had more likely abnormal troponin (P\u3c0.001) higher C-reactive protein (P\u3c0.001), higher indexed LV end-diastolic volume (P\u3c0.001) and mass (P=0.015), worse LV ejection fraction (P\u3c0.001), and worse LV strain (4CH-LVLS, P=0.002; mid-LVCS, P=0.001). Covariate-adjusted individual models for each strain parameter showed that 4CH-LVLS (adjusted odds ratio, 1.09 [95% CI, 1.07-1.12]), mid-LVCS (adjusted odds ratio, 1.06 [95% CI, 1.04-1.09]), worst LV strain Z score between 4CH-LVLS and mid-LVCS (adjusted odds ratio, 1.30 [95% CI, 1.21-1.41]), and early diastolic longitudinal strain rate (adjusted odds ratio, 1.68 [95% CI, 1.26-2.23]) at admission were found to be associated with adverse outcomes. CONCLUSIONS: About half of patients with MIS-C had abnormal LV strain during hospitalization. 4CH-LVLS, mid-LVCS, the most abnormal strain Z score, and early diastolic longitudinal strain rate at admission were independently associated with in-hospital adverse cardiovascular outcome. These data may help early characterization and prognostication in MIS-C
The State of Pediatric Concurrent Hospice Care in the United States
No full textThe Patient Protection and Affordable Care Act (ACA) required all state Medicaid programs to pay for both curative and hospice services for children and adolescents. The purpose of this Special Article report is to quantify and describe the use of concurrent care for children, including a depiction of the barriers and benefits according to community-based hospice organizations in the United States. A total of 295 hospice organizations from 50 states and Washington, DC responded to the National Alliance for Care at Home call for engagement. Almost three-quarters of responding organizations admit children under concurrent care. An average of 38% (median 10%) of admitted pediatric patients are cared for under concurrent care. There was a notable lack of uptake of diverse reimbursement models relevant to concurrent care. Definitions of concurrent care focused on location of care and access to ongoing treatments without defining services. Responses tended toward an emphasis on regulatory/compliance language rather than goals of care or partnership focus. Challenges and barriers to concurrent care were quantitatively and qualitatively described as confusion, complexities, lack of consistency, cumbersomeness, and poor cross-partner communication. Policy and reimbursement model clarification is warranted to improve the potential benefits of this coverage for children and their families. As the ACA is currently at risk of discontinuation and Medicaid is at risk of decreased funding, the pediatric community should leverage advocacy for improved concurrent care coverage approaches that are clear, consistent, and compassionately attuned to the needs of children and their families
Adaptation, Innovation, and Resilience: Serendipitous Outcomes of a Rapid Transition to Virtual Learning
No full textBACKGROUND: The COVID-19 pandemic presented challenges but also opportunities for growth and innovation in education, especially in advanced practice registered nursing programs. This article explores the rapid shift from in-person to virtual learning and highlights the positive outcomes. METHOD: The study examines the impact of this transition on grades, evaluations, preceptor feedback, and board certification pass rates. RESULTS: Clinical training was initially affected, but overall educational outcomes remained robust and even improved in some cases. CONCLUSION: The rapid shift to remote learning led to the development of digital tools and platforms for virtual instruction. This change prompted a re-evaluation of educational strategies, emphasizing self-paced learning, digital literacy, and real-world application integration. The move highlighted the importance of accessibility and inclusivity, leading to initiatives to bridge the digital divide. Thus, while disruptive, the pandemic has fostered resilience and innovation that has positively advanced the future of nursing education
Understanding Strategies to Translate Knowledge on Hookah Smoking: A Mixed Methods Study
No full textBackground: One tobacco trend of the 21 st century is smoking hookah or waterpipes. Hookah smoking is thriving on a false widespread belief that it is a safe alternate to smoking cigarettes when in fact it has adverse effects on health and is not safer. Hookah use has especially become popular for young adults and college students.
Study Objectives: The purpose of this study is to generate knowledge to inform university administration (health education personnel and campus policy makers) on what the psychosocial profile of a hookah smoker is, including risk factors, and how they can use messaging to reduce hookah smoking during college years and beyond.
Methods: The study followed a mixed methods convergent design. For the quantitative arm, data from the Population Assessment of Tobacco and Health (PATH) Study was subset to 18-24 year olds (N=1,459) and used to examine the potential predictors of hookah smoking for non-users and frequency. The primary outcome for the study, hookah smoking frequency, was examined across three different levels – specifically, daily/weekly, monthly, and every couple of months. For the qualitative arm, literature was used to explore hookah smoking in focus groups with undergraduate students (N=13). Data from the quantitative and qualitative arms were triangulated through the creation of a Venn diagram that shows the connections between results. Recommendations were generated for university administration on communication strategies to supplement tobacco control policies.
Results: Degree enrollment was a significant predictor of hookah smoking among ever users. For reasons for smoking hookah, two significant factors were predictive of smoking hookah daily/weekly when compared to monthly smokers: enrollment and smoking because of the different flavors. When daily/weekly smokers were compared to those smoking every couple of months, income and education were significant factors. Comparing enrolled to not enrolled, significant factors predictive of hookah smoking included gender, income, education, other tobacco product use, alcohol use, usually smoke at home, usually smoke at a hookah bar, addiction to tobacco products, strong cravings to smoke, belief on harmfulness to one’s own health and others, satisfaction with social activities, and self-perception of physical health/overall health/quality of life.
According to qualitative findings, the main factors influencing decisions to smoke are culture, family, level of knowledge, social interactions, ease of access, and lack of alternatives for other activities. Mixed methods results show that messaging needs to increase level of knowledge; give alternatives; come from people of influence; and be conveyed through social media, TV, and radio.
Conclusions: Based on the findings of this study, recommendations can be made to university personal on health communication strategies. Universities should raise awareness on factors outside the university influencing hookah smoking, share lists of alternative activities that give a similar experience, start a knowledge campaign to increase understanding of health effects, and utilize social media in their messaging. By implementing the recommendations, universities can help decrease the popularity of hookah smoking and ultimately provide a safer environment for the student body
Building a Quantitative Telemedicine Platform for Myasthenia Gravis: Augmenting the Physical Examination
No full textMyasthenia gravis (MG), a fluctuating autoimmune neuromuscular disease, presents unique challenges for remote assessment due to its reliance on detailed physical examination. To address this, we developed a quantitative telemedicine platform that augments traditional neurological assessments using computer vision, signal processing, and augmented intelligence. In response to the COVID-19 pandemic that motivated a shift to telemedicine evaluations, the Myasthenia Gravis Core Exam (MGCE) was developed by the rare disease consortium MGNet, to provide guidance in the performance of telemedicine clinical encounters. The MGCE includes eight sentinel tasks such as ptosis assessment, sit-to-stand, and speech-based respiratory measures, all amenable to digital capture. To assess the reproducibility and reliability of the MGCE, videos of 52 MG patients across six centers were performed with each having examinations performed twice. We utilized this unique resource to apply machine learning algorithms to extract clinically relevant features from video and audio data, enabling quantitation of continuous variation, in contrast to the categorical measures (mild, moderate, and severe) used in standard clinical assessments. Inter-rater variability prompted the development of a reproducibility of score metric and revealed that variations in examiner instructions and video quality significantly affect reliability. Our findings suggest that a digital examination framework can enhance MG assessment precision, reduce variability in physical examination evaluation, and support the telemedicine examination. This scalable approach has the potential to integrate digital biomarkers into neuromuscular disease care and clinical trials
