Food allergy-related bullying: Risk factors and psychosocial functioning

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

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

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

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

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)

Efficacy and Safety of Higher Doses of Levofloxacin for MDR-TB: A Randomized Placebo-controlled Phase 2 Trial

BACKGROUND: Evaluation of optimal dosing has generally been inadequate during TB drug development. Fluoroquinolones are central to TB treatment. We aimed to determine the dose of levofloxacin needed to achieve maximal efficacy and acceptable safety and tolerability as part of a multidrug TB regimen. METHODS: Opti-Q was an international, multi-center, randomized, placebo-controlled, phase II trial. Eligible participants with TB resistant to isoniazid and rifampicin but susceptible to fluoroquinolones (MDR-TB) were randomized to receive one of four weight-adjusted once-daily doses of levofloxacin given for 24 weeks(168 doses): 11mg/kg(750mg), 14mg/kg(750mg/1000mg), 17 mg/kg(1000mg/1250mg) or 20mg/kg(1250mg/1500mg) alongside a multidrug regimen. The primary efficacy outcome was time to sputum culture conversion and the primary safety outcome was grade 3 or higher adverse events. FINDINGS: 111 participants were randomized from three sites in South Africa and Peru. 83(75%) had cavities on chest x-ray, 55(50%) had a smear grading of 3+, median BMI was 20.4 kg/m. Median levofloxacin AUC/MIC was 573, 633, 918 and 1343 across the four treatment arms. There was no difference in time to culture conversion on solid or liquid media by treatment arm (stratified log-rank p=0.282), by tertile of AUC/MIC (p=0.350), or by dose received (p=0.723); 69.3%, 74.8%, 70.6% and 78.3% achieved culture conversion after 8 weeks on solid media respectively across the treatment arms; 64.6%, 69.5%, 52.6% and 69.6% in liquid culture. More participants experienced a grade 3-5 adverse event by dose (37.0% and 16.0% in the highest and lowest dose groups respectively, p=0.042, Cochran-Armitage test for trend) and by tertile of AUC (p=0.011). INTERPRETATION: As part of a multidrug regimen, doses of levofloxacin above 1000mg resulted in greater exposures and increased frequency of adverse events but did not result in faster time to sputum culture conversion. A dose of 1000mg daily can achieve the target exposure in nearly all adults and was well tolerated. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/). Clinical trial registration available at www. CLINICALTRIALS: gov, ID: NCT0191839

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