Jacobs Institute of Women's Health

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    Food allergy-related bullying: Risk factors and psychosocial functioning

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    BACKGROUND: Food allergy (FA)-related bullying is common, yet little is known about risk factors for FA-related bullying or the relationship between FA-related bullying and psychosocial wellbeing. This study aimed to (1) identify sociodemographic and clinical factors associated with risk of FA-related bullying in children with FA, and (2) evaluate the psychosocial functioning of children and parents reporting FA-related bullying. METHODS: This was a cross-sectional survey study of children ages 5-17 years with immunoglobulin E (IgE)-mediated FA and their parents, recruited from Boston Children\u27s Hospital (BCH) and through social media outlets. Children and parents with versus without a history of FA-related bullying were compared on sociodemographic and clinical characteristics and FA-related psychosocial outcomes using validated instruments. RESULTS: In this cohort of 295 child-parent dyads, the median child age was 8.0 years, 53.2% of children were male, and parent respondents were primarily mothers (96.6%). Reported lifetime prevalence of FA-related bullying was 36.6%. FA-related bullying was associated with certain child characteristics, including coming from a household at risk of food insecurity (FI) (12.0% of bullied children v. 2.2% of not bullied children were from food insecure households, p \u3c .001), having coexisting atopic and mental health conditions-particularly anxiety (30.6% of bullied children v. 8.6% of not bullied children carried an anxiety disorder diagnosis, p \u3c .001)-and having a history of more severe FA reactions. FA-related bullying was associated with elevated concerns in child and parental FA-related psychosocial functioning domains. CONCLUSION: Pediatricians and allergists should screen for FA-related bullying and offer families appropriate guidance around management of FA-related bullying

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    Medium: Photograph (Black & White).https://hsrc.himmelfarb.gwu.edu/artshow_gallery_2025/1014/thumbnail.jp

    Psychometric Evaluation of the Scleroderma Skin Questionnaire: A Novel Patient-Reported Outcome for Skin Disease in Patients With Systemic Sclerosis

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    OBJECTIVE: We aimed to evaluate the psychometric properties of the Scleroderma Skin Questionnaire (SSQ), a novel patient-reported outcome (PRO) to assess systemic sclerosis (SSc)-related skin symptoms. METHODS: Participants were recruited from the SSc Collaborative National Quality and Efficacy Registry (CONQUER). Internal consistency was determined using Cronbach α and McDonald ω total (ωt). The correlation of the SSQ was assessed with the modified Rodnan skin score (mRSS), physician global assessment (PGA), Scleroderma Health Assessment Questionnaire, 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29), and patient global assessment to assess criterion, convergent, and divergent validity. Correlations were also assessed between patients\u27 self-reported recall of skin changes over the past 6 months ( SSQ 6-Month ) and 6-month change in mRSS. RESULTS: The SSQ was administered to 799 adults (mean age 52.7; 83% female) enrolled in CONQUER. Cronbach α was 0.90 and ωt was 0.92, indicating high internal consistency. The SSQ was moderately correlated with mRSS (r 0.56), with stronger correlations in diffuse (r 0.54) vs limited cutaneous subtypes (r 0.24; all P \u3c 0.05). The SSQ was also moderately-to-strongly correlated with PROMIS-29 physical function (r -0.50) and pain interference subscales (r 0.61), strongly with Health Assessment Questionnaire score (r 0.63) and severity subscale (r 0.62), and moderately with PGA SSc activity score (r 0.48; all P \u3c 0.05). SSQ 6-Month correlated weakly with the 6-month change in mRSS (r 0.26; P \u3c 0.05). CONCLUSION: SSQ demonstrated high reliability and moderate correlation with mRSS and legacy PROs. This study provides initial support for SSQ, but not SSQ 6-Month, to assess skin symptoms in patients with SSc

    Incidence and Outcome of Cataract in Eyes with Scleritis and Episcleritis

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    PURPOSE: To estimate the incidence and predictive factors for cataract in eyes with episcleritis and scleritis, and to evaluate the outcome of cataract surgery in those eyes. DESIGN: Retrospective cohort study at uveitis subspecialty centers. METHODS: One thousand three hundred eighty-four eyes with non-infectious scleritis and episcleritis at risk of cataract were included. Predictive factors for cataract development were assessed by multivariable Cox regression. The main outcomes were development of cataract, defined as the first reduction of presenting visual acuity \u3c20/40 attributed to cataract or else occurrence of cataract surgery itself. A second cohort of eyes with episcleritis and scleritis that underwent cataract surgery was evaluated for postoperative outcomes. Logistic regression was utilized to assess variables associated with visual acuity 20/40 or better one year after cataract surgery. RESULTS: Seventy-six eyes developed cataract (incidence = 0.025/eye-year, 95% confidence interval: 0.019-0.031). Age ≥65 years, elevated intraocular pressure ≥30 mmHg, use of oral corticosteroids at the preceding visit, and anterior chamber inflammatory activity were associated with increased cataract incidence. Race/ethnicity, type of scleritis, and bilaterality were unassociated with cataract risk after adjustment. Among 79 cataractous eyes that underwent cataract surgery, median presenting visual acuity improved by 6 ETDRS lines. Pre-operative factors including duration of inflammation, immunotherapy use, and corticosteroid use were not significantly associated with odds of post-operative visual acuity 20/40 or better. CONCLUSIONS: Under subspecialty management, the incidence of cataract was low in eyes with episcleritis and scleritis. Cataract surgery was associated with large and sustained improvements in visual acuity

    Boosting Skin Microcirculation for Androgenetic Alopecia: Does It Work?

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    Safety and efficacy of chronic weekly rozanolixizumab in generalized myasthenia gravis: the randomized open-label extension MG0004 study

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    BACKGROUND: In the Phase 3 MycarinG study (NCT03971422), six once-weekly subcutaneous infusions of rozanolixizumab significantly improved myasthenia gravis (MG)-specific outcomes versus placebo in patients with acetylcholine receptor or muscle-specific tyrosine kinase autoantibody-positive generalized MG (gMG). Following completion of MycarinG, patients could enroll in the open-label extension MG0004 study (NCT04124965) to receive chronic weekly rozanolixizumab. METHODS: Patients were re-randomized 1:1 to once-weekly rozanolixizumab 7 or 10 mg/kg for up to 52 infusions. The primary endpoints were the occurrence of treatment-emergent adverse events (TEAEs) and TEAEs leading to rozanolixizumab discontinuation. After ≥6 visits/infusions patients could switch to the MG0007 study (NCT04650854) to receive cyclic rozanolixizumab treatment. RESULTS: In MG0004, 70 patients received rozanolixizumab 7 mg/kg (n = 35) or 10 mg/kg (n = 35). Mean treatment duration was 22.9 and 23.7 weeks, respectively, due to rollover into MG0007. TEAEs were reported in 60/70 (85.7%) patients; most were mild/moderate. The most frequently reported TEAEs were headache (25/70 [35.7%]), diarrhea (13/70 [18.6%]) and decreased blood immunoglobulin G (11/70 [15.7%]). There were no opportunistic, serious or severe infections, serious or severe hypersensitivity or injection-site reactions, any anaphylactic reactions or albumin or lipid abnormalities. Maximum mean reduction from baseline in MG Activities of Daily Living score was 3.1 in the 7 mg/kg group and 4.1 in the 10 mg/kg group. CONCLUSION: Chronic weekly rozanolixizumab for up to 52 infusions was generally well tolerated, and clinically relevant improvements across MG-specific outcomes were maintained, supporting the long-term use of rozanolixizumab in patients with gMG. TRIAL REGISTRATION: NCT04124965 (registered October 11, 2019)

    Impact of COVID-19 on Medicare Reimbursement and Glaucoma Procedure Utilization: A Payment-Volume Elasticity and Trends Analysis

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    PURPOSE: To examine how the COVID-19 pandemic impacted the relationship between Medicare reimbursement and glaucoma procedure service volume in the United States. DESIGN: Retrospective, longitudinal database study. PARTICIPANTS: A complete dataset of all glaucoma procedures performed on Medicare Part B beneficiaries from 2019 to 2022. METHODS: Linear mixed-effects model using Medicare Part B data, controlling for year, charges, denials, reimbursement-to-charge ratio (RCR), service setting, CPT code, state, Medicare population, number of ophthalmologists, and median income. RCR was calculated as the ratio of weighted mean reimbursement to weighted mean charge, representing the proportion of reimbursed charges. Weighted averages for denials, charges, and reimbursements (adjusted for inflation) were also calculated. MAIN OUTCOME MEASURES: Payment-volume elasticities, defined as the percent change in procedure volume per 1% change in Medicare payment, for traditional glaucoma surgeries (tubes and shunts), minimally invasive glaucoma surgeries (MIGS), and laser procedures. Additional measures included weighted averages of charges, reimbursements, denials, and RCR across procedure categories and service settings. RESULTS: Traditional surgeries showed a 2.3% decrease in volume per 1% payment increase (95% CI: -2.9% to -1.7%; p \u3c 0.001; Rc = 0.89) and a 10.2% decline in volume. Mean reimbursement for traditional surgeries decreased by 5%, with a 7.7% drop in RCR. Laser procedures exhibited a 6.7% volume decrease per 1% payment increase (95% CI: -7.1% to -6.2%; p \u3c 0.001; Rc = 0.97) and a 16% total decline, with no change in RCR. MIGS declined by 16% overall but demonstrated an 8.3% volume increase per 1% payment rise (95% CI: 7.9% to 8.7%; p \u3c 0.001; Rc = 0.90), with a 64% improvement in RCR. Overall, glaucoma procedure volumes fell by 15.6%, mean reimbursement decreased by 7.3%, and denied claims increased by 46.7%. ASCs experienced a 15.2% volume decline but an 11.5% increase in reimbursement, supported by a 39.7% rise in RCR. CONCLUSION: Glaucoma procedure volumes declined between 2019-2022, particularly for traditional surgeries and MIGS. Traditional and laser procedures had negative payment-volume elasticities, while MIGS showed positive elasticity. These findings suggest factors beyond reimbursement rates, like shifts to less invasive treatments and COVID-19 disruptions, significantly influenced clinical decision-making

    Health System Expansion and Changes in Medicare Beneficiary Utilization of Safety Net Providers

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    BACKGROUND: Evidence is limited on insured patients\u27 use of safety net providers as vertically integrated health systems spread throughout the United States. OBJECTIVES: To examine whether market-level health system penetration is associated with: (1) switches in Medicare beneficiaries\u27 usual source of primary care from federally qualified health centers (FQHCs) to health systems; and (2) FQHCs\u27 overall Medicare patient and visit volume. RESEARCH DESIGN: Beneficiary-level discrete-time survival analysis and market-level linear regression analysis using Medicare fee-for-service claims data from 2013 to 2018. SUBJECTS: A total of 659,652 Medicare fee-for-service beneficiaries aged 65 and older lived in one of 27,386 empirically derived primary care markets whose usual source of care in 2013 was an FQHC or a non-FQHC-independent physician organization that predominantly served low-income patients. MEASURES: Beneficiary-year measure of the probability of switching to health system-affiliated physician organizations and market-year measures of the number of FQHC visits by Medicare beneficiaries, number of beneficiaries attributed to FQHCs, and FQHC Medicare market shares. RESULTS: During 2013-2018, 16.5% of beneficiaries who sought care from FQHCs switched to health systems. When health system penetration increases from the 25th to 75th percentile, the probability of Medicare FQHC patient switching increases by 4.6 percentage points, with 22 fewer Medicare FQHC visits and 4 fewer beneficiaries attributed to FQHCs per market year. Complex patients and patients who sought care from non-FQHC, independent physician organizations exhibited higher rates of switching to health systems. CONCLUSIONS: Health system expansion was associated with the loss of Medicare patients by FQHCs, suggesting potential negative spillovers of vertical integration on independent safety net providers

    Calibrating a functional assay for variant classification in RYR1-related malignant hyperthermia susceptibility

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    PURPOSE: Identifying individuals with pathogenic variants for RYR1-related Malignant Hyperthermia Susceptibility (MHS) could reduce morbidity and mortality due to MH reactions. Realization of this goal requires knowledge of variant pathogenicity, and proper weighting of functional assays is important for accurate variant classification. Caffeine-induced Ca2+ release assays can be used to support pathogenicity per the ClinGen Variant Curation Expert Panel (VCEP). However, the caffeine-induced Ca2+ release assay lacks formal validation with known pathogenic and benign variants. METHODS: Fifteen benign/likely benign and six pathogenic/likely pathogenic RYR1 variants were used to calibrate the caffeine-induced Ca2+ release assay using a multi-mode microplate reader. Five variants of unknown significance (VUS) were assayed for possible reclassification. RESULTS: Our data support use of the caffeine-induced Ca2+ release assay at a moderate weight per the American College of Medical Genetics and Genomics pathogenicity criteria schema with a positive likelihood ratio of 12.14:1 (pathogenicity) and a negative likelihood ratio of 0.22:1 (4.5:1 benignity). Using this validated assay, two of five VUS were reclassified as likely benign. CONCLUSION: Formal validation of the caffeine-induced Ca2+ release assay supports the VCEP functional criteria weighting at moderate strength based on these data. Additional variants should be assayed to shift more from VUS to benign or pathogenic classifications

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