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Readmission to acute care from the inpatient rehabilitation facility (IRF) setting is potentially preventable and an important target of quality improvement and cost savings. The objective of this study was to develop a risk calculator to predict 30-day all-cause readmissions from the IRF setting.Retrospective database analysis using the Uniform Data System for Medical Rehabilitation (UDSIn total, 956 US inpatient rehabilitation facilities and 1,849,768 IRF discharges comprising patients from 14 impairment groups.Logistic regression models were developed to calculate risk-standardized 30-day all-cause hospital readmission rates for patients admitted to an IRF. Models for each impairment group were assessed using 12 common clinical and demographic variables and all but 4 models included various special variables. Models were assessed for discrimination (c-statistics), calibration (calibration plots), and internal validation (bootstrapping). A readmission risk scoring system was created for each impairment group population and was graphically validated.The mean age of the cohort was 68.7 (15.2) years, 50.7% were women, and 78.3% were Caucasian. Medicare was the primary payer for 73.1% of the study population. The final models for each impairment group included between 4 and 13 total predictor variables. Model c-statistics ranged from 0.65 to 0.70. There was good calibration represented for most models up to a readmission risk of 30%. Internal validation of the models using bootstrap samples revealed little bias. Point systems for determining risk of 30-day readmission were developed for each impairment group.Multivariable risk factor algorithms based upon administrative data were developed to assess 30-day readmission risk for patients admitted from IRF. This report represents the development of a readmission risk calculator for the IRF setting, which could be instrumental in identifying high risk populations for readmission and targeting resources towards a diverse group of IRF impairment groups.

BackgroundDepression is a common neuropsychiatric consequence of stroke, but there is little empiric evidence regarding clinical diagnosis and management of poststroke depression.MethodsRetrospective cohort study among 831 471 privately insured patients with first stroke in the USA from 2003 to 2020. We identified diagnoses of poststroke depression using codes from the International Classification of Diseases. We identified treatment based on prescriptions for antidepressants. We used Cox proportional hazards regression analysis to examine rates of poststroke depression diagnosis by gender, age and race/ethnicity. Among individuals who received a diagnosis of poststroke depression, we estimated treatment rates by gender, race/ethnicity and age using negative binomial regression analysis.ResultsAnnual diagnosis and treatment rates for poststroke depression increased from 2003 to 2020 (both p for trendConclusionsIn this insured population, we identify potential inequities in clinical management of poststroke depression by gender, race/ethnicity and age that may reflect barriers other than access to healthcare.

Misophonia is a complex disorder characterized by a heightened reaction to certain sounds and associated stimuli. While there is no uniformly accepted treatment to date, different intervention approaches are being investigated. Individual's perceptions of different misophonia treatment methods may affect compliance and satisfaction with treatment options. We sought to gather data on patient perceptions of currently available misophonia treatments.Using an online survey, we collected data about treatment preferences, treatment usage, and diagnosis history from parents of children with misophonia (N = 141) and adults with misophonia (N = 252).Most respondents were not satisfied with misophonia treatments that they or their children had previously received. Audiologic interventions including active and passive noise cancelling and lifestyle modifications were rated as most appropriate for treatment of misophonia by both parent and adult respondents.Because of the descriptive nature of this study, we chose to use a completer-only approach to ensure the data reflect the true responses of participants, though this did result in a meaningful proportion of missing data. Participants were selected through convenience sampling and responses were self-reported. Individuals with more severe misophonia symptoms may be more likely to participate and complete a research survey.Most interventions are considered inappropriate by parents of youth with misophonia and by adults with misophonia. This should be interpreted in the light of a general lack of misophonia-specific interventions. Findings suggest dissatisfaction with currently available treatments and an opportunity for development of effective treatment strategies corresponding to participants' preferences. Deeper understanding of treatment preferences has the potential to guide future treatment development.

Current systemic treatments for children younger than 6 years with moderate-to-severe atopic dermatitis that is uncontrolled with topical therapies might have suboptimal efficacy and safety. Dupilumab is approved for older children and adults with atopic dermatitis and for other type 2 inflammatory conditions. We aimed to evaluate efficacy and safety of dupilumab with concomitant low-potency topical corticosteroids in children aged 6 months to younger than 6 years with moderate-to-severe atopic dermatitis.This randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial was conducted in 31 hospitals, clinics, and academic institutions in Europe and North America. Eligible patients were aged 6 months to younger than 6 years, with moderate-to-severe atopic dermatitis (Investigator's Global Assessment [IGA] score 3-4) diagnosed according to consensus criteria of the American Academy of Dermatology, and an inadequate response to topical corticosteroids. Patients were randomly assigned (1:1) to subcutaneous placebo or dupilumab (bodyweight ≥5 kg to15 kg: 200 mg; bodyweight ≥15 kg to30 kg: 300 mg) every 4 weeks plus low-potency topical corticosteroids (hydrocortisone acetate 1% cream) for 16 weeks. Randomisation was stratified by age, baseline bodyweight, and region. Patient allocation was done via a central interactive web response system, and treatment allocation was masked. The primary endpoint at week 16 was the proportion of patients with IGA score 0-1 (clear or almost clear skin). The key secondary endpoint (coprimary endpoint for the EU and EU reference market) at week 16 was the proportion of patients with at least a 75% improvement from baseline in Eczema Area and Severity Index (EASI-75). Primary analyses were done in the full analysis set (ie, all randomly assigned patients, as randomly assigned) and safety analyses were done in all patients who received any study drug. This study was registered with ClinicalTrials.gov, NCT03346434.Between June 30, 2020, and Feb 12, 2021, 197 patients were screened for eligibility, 162 of whom were randomly assigned to receive dupilumab (n=83) or placebo (n=79) plus topical corticosteroids. At week 16, significantly more patients in the dupilumab group than in the placebo group had IGA 0-1 (23 [28%] vs three [4%], difference 24% [95% CI 13-34]; p0·0001) and EASI-75 (44 [53%] vs eight [11%], difference 42% [95% CI 29-55]; p0·0001). Overall prevalence of adverse events was similar in the dupilumab group (53 [64%] of 83 patients) and placebo group (58 [74%] of 78 patients). Conjunctivitis incidence was higher in the dupilumab group (four [5%]) than the placebo group (none). No dupilumab-related adverse events were serious or led to treatment discontinuation.Dupilumab significantly improved atopic dermatitis signs and symptoms versus placebo in children younger than 6 years. Dupilumab was well tolerated and showed an acceptable safety profile, similar to results in older children and adults.Sanofi and Regeneron Pharmaceuticals.

To evaluate improvement during the (a) cognitive and (b) exposure therapy phases of cognitive-behavioral therapy (CBT) for autistic youth with anxiety disorders.Participants were 148 autistic youth (aged 7-13; 77% male; 64% White) with clinically significant anxiety who were randomized to standard or adapted CBT. Clinician-rated anxiety severity was recorded at each appointment. Trajectories of change during (a) the cognitive phase and (b) the exposure phase of treatment were analyzed using piecewise multilevel modeling.Compared to the psychoeducation and cognitive therapy phases, the exposure phase corresponded with significantly more rapid symptom reduction, b = -.11, 95% CI [-.13, -.071]. This finding was true for standard CBT, which included nine sessions prior to exposure initiation (on average), as well as for CBT personalized for autistic youth, which introduced exposure following the fifth session (on average). In contrast, compared with improvements during initial psychoeducation sessions, the introduction of cognitive skills corresponded with significantly slower symptom reduction, b = .066, 95% CI [.020, .11]. This finding was also true for both adapted and standard CBT.Results underscore the central role of exposure in the treatment of anxiety among autistic youth and question the utility of cognitive strategies without subsequent practice of these skills during exposure. Assuming a working relationship, therapists should consider moving through the preexposure coping phase of CBT quickly. Future research should evaluate the extent to which exposure can maintain its potency while minimizing coping skill preparation. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

As novel liquid chromatography-mass spectrometry (LC-MS) technologies for proteomics offer a substantial increase in LC-MS runs per day, robust and reproducible sample preparation emerges as a new bottleneck for throughput. We introduce a novel strategy for positive-pressure 96-well filter-aided sample preparation (PF96) on a commercial positive-pressure solid-phase extraction device. PF96 allows for a five-fold increase in throughput in conjunction with extraordinary reproducibility with Pearson product-moment correlations on the protein level of r = 0.9993, as demonstrated for mouse heart tissue lysate in 40 technical replicates. The targeted quantification of 16 peptides in the presence of stable-isotope-labeled reference peptides confirms that PF96 variance is barely assessable against technical variation from nanoLC-MS instrumentation. We further demonstrate that protein loads of 36-60 μg result in optimal peptide recovery, but lower amounts ≥3 μg can also be processed reproducibly. In summary, the reproducibility, simplicity, and economy of time provide PF96 a promising future in biomedical and clinical research.

Background Despite a better understanding of the epidemiology, pathogenesis, and management of patients with anaphylaxis, there remain knowledge gaps. Enumerating and prioritizing these gaps would allow limited scientific resources to be directed more effectively. Objective We sought to systematically describe and appraise anaphylaxis knowledge gaps and future research priorities based on their potential impact and feasibility. Methods We convened a 25-member multidisciplinary panel of anaphylaxis experts. Panelists formulated knowledge gaps/research priority statements in an anonymous electronic survey. Four anaphylaxis themed writing groups were formed to refine statements: (1) Population Science, (2) Basic and Translational Sciences, (3) Emergency Department Care/Acute Management, and (4) Long-Term Management Strategies and Prevention. Revised statements were incorporated into an anonymous electronic survey, and panelists were asked to rate the impact and feasibility of addressing statements on a continuous 0 to 100 scale. Results The panel generated 98 statements across the 4 anaphylaxis themes: Population Science (29), Basic and Translational Sciences (27), Emergency Department Care/Acute Management (24), and Long-Term Management Strategies and Prevention (18). Median scores for impact and feasibility ranged from 50.0 to 95.0 and from 40.0 to 90.0, respectively. Key statements based on median rating for impact/feasibility included the need to refine anaphylaxis diagnostic criteria, identify reliable diagnostic, predictive, and prognostic anaphylaxis bioassays, develop clinical prediction models to standardize postanaphylaxis observation periods and hospitalization criteria, and determine immunotherapy best practices. Conclusions We identified and systematically appraised anaphylaxis knowledge gaps and future research priorities. This study reinforces the need to harmonize scientific pursuits to optimize the outcomes of patients with and at risk of anaphylaxis.

People living with burn injury often face long-term physical and psychological sequelae associated with their injuries. Few studies have examined the impacts of burn injuries on long-term health and function, life satisfaction, and community integration beyond 5 years postinjury. The purpose of this study was to examine these outcomes up to 20 years after burn injury.Data from the Burn Model System National Longitudinal Database (1993-2020) were analyzed. Patient-reported outcome measures were collected at discharge (preinjury status recall) and 5 years, 10 years, 15 years, and 20 years after injury. Outcomes examined were the SF-12/VR-12 Physical Component Summary and Mental Component Summary, Satisfaction with Life Scale, and Community Integration Questionnaire. Trajectories were developed using linear mixed models with repeated measures of outcome scores over time, controlling for demographic and clinical variables.The study population included 421 adult burn survivors with a mean age of 42.4 years. Lower Physical Component Summary scores (worse health) were associated with longer length of hospital stay, older age at injury and greater time since injury. Similarly, lower Mental Component Summary scores were associated with longer length of hospital stay, female sex, and greater time since injury. Satisfaction with Life Scale scores decrease negatively over time. Lower Community Integration Questionnaire scores were associated with burn size and Hispanic/Latino ethnicity.Burn survivors' physical and mental health and satisfaction with life worsened over time up to 20 years after injury. Results strongly suggest that future studies should focus on long-term follow-up where clinical interventions may be necessary.Prognostic and Epidemiologic; Level III.

For individuals with obsessive-compulsive disorder (OCD), family accommodation of symptoms, such as over-reassurance, participation in rituals, or facilitation of avoidance, is one of the key factors associated with symptom severity, maintenance, and related impairment. Most studies have assessed accommodation behaviors based on reports from family members or other loved ones. Recently, a patient-rated questionnaire, the Family Accommodation Scale for OCD-Patient Version (FAS-PV) was developed to assess family accommodation from the patient's perspective. This study investigated the factor structure of the FAS-PV and clinical variables associated with patient-reported family accommodation in a sample of 151 treatment-seeking adults with OCD. A confirmatory factor analysis suggested that a 4-factor model best characterized the scale, with the following factors: (1) participation in symptoms, (2) avoidance of OCD triggers, (3) taking on responsibilities, and (4) modifying responsibilities. Internal consistency was high for the total score and for scores on the 4 subscales of the FAS-PV. Approximately 87% of the sample reported accommodation behaviors at some level. Family accommodation was positively correlated with OCD symptom severity and functional disability, and partially mediated the associations between these 2 factors, so that greater OCD severity was associated with greater accommodation, which, in turn, was associated with greater disability. Our findings parallel those of studies that have employed other versions of the FAS and suggest that the FAS-PV is a useful tool for assessing family accommodation of OCD symptoms from the patient's perspective.

The transition from early childhood to teen years (5–12) is a critical time of development, which can be made particularly challenging by a burn injury. Assessing postburn recovery during these years is important for improving pediatric survivors’ development and health outcomes. Few validated burn-specific measures exist for this age group. The purpose of this study was to generate item pools that will be used to create a future computerized adaptive test (CAT) assessing postburn recovery in school-aged children. Item pool development was guided by the previously developed School-Aged Life Impact Burn Recovery Evaluation (SA-LIBRE5–12) conceptual framework. The item pool development process involved a systematic literature review, extraction of candidate items from existing legacy measures, iterative item review during expert consensus meetings, and parent cognitive interviews. The iterative item review with experts consisted of six rounds. A total of 10 parent cognitive interviews were conducted. The three broad themes of concern were items that needed 1) clarification, needed context, or were vague, 2) age dependence and relevance, and 3) word choice. The cognitive interviews indicated that survey instructions, recall period, item stem, and response choices were interpretable by respondents. Final item pool based on parental feedback consists of 57, 81, and 60 items in physical, psychological, and family and social functioning, respectively. Developed item pools (n = 198) in three domains are consistent with the existing conceptual framework. The next step involves field testing the item pool and calibration using item response theory to develop and validate the SA-LIBRE5–12 CAT Profile.

BACKGROUND: Total serum IgE (tIgE) is an important intermediate phenotype of allergic disease. Whole genome genetic association studies across ancestries may identify important determinants of IgE. OBJECTIVE: By leveraging data from the NHLBI Trans-Omics for Precision Medicine (TOPMed) program, the Consortium on Asthma among African-ancestry Populations in the Americas (CAAPA) and the Atopic Dermatitis Research Network (ADRN), we aim to increase understanding of genetic variants affecting tIgE production across the ancestry and allergic disease spectrum (N=21,901). METHODS: We performed genome-wide association within strata of study, disease, and ancestry groups, and combined results via a meta-regression approach that models heterogeneity attributable to ancestry. We also tested for association between HLA alleles called from whole genome sequence data and tIgE, assessing replication of associations in HLA alleles called from genotype array data. For details, please see the Methods section in this article’s Online Repository at www.jacionline.org. RESULTS: We identified six loci at genome-wide significance (P

Acute pediatric burn injuries often result in chronic sequelae that affect physical, psychological, and social outcomes. To date, no review has comprehensively reported on the impact of burn injuries across all three domains in school-aged children. The aim of this systematic review was to identify published literature that focuses on the impact of burn injuries on physical, psychological, or social functioning, and report upon the nature of study characteristics and their outcomes. We included literature published after 1980, focusing on burn outcomes in children aged 5 to 18 years. Each eligible study was systematically reviewed and primary outcomes were classified into outcome domains based on existing frameworks. Fifty-eight studies met inclusion criteria, and reported on physical (n = 24), psychological (n = 47), and social (n = 29) domains. The majority of the studies had sample sizes of

Depression and post-traumatic stress are common psychiatric comorbidities following burn injury. The purpose of this study was to develop an admission scoring system that assesses the risk of development of depression or post-traumatic symptoms in the burn population. This study is a retrospective review of the prospectively collected Burn Model System National Database. Adult burn survivors enrolled from 2014-2018 (n=486) were included. The primary outcome was the presence of depression or post-traumatic stress symptoms at 6, 12, or 24 months post-injury. Logistic regression analysis was used to identify demographic and clinical predictors of depression and post-traumatic stress symptoms. A risk scoring system was then created based on assigning point values to relevant predictor factors. The study population had a mean age of 46.5±15.8 years, mean burn size of 18.3±19.7%, and was 68.3% male. Prior to injury, 71.3% of the population was working, 47.9% were married, and 50.8% had completed more than a high school education. An 8-point risk scoring system was developed using the following predictors of depression or post-traumatic stress symptom development: gender, psychiatric treatment in the past year, graft size, head/neck graft, etiology of injury, and education level. This study is the first to develop a depression and post-traumatic stress symptom risk scoring system for burn injury. This scoring system will aid in identifying burn survivors at high risk of long-term psychiatric symptoms that may be used to improve screening, monitoring, timely diagnosis and interventions.

Px563L is a next-generation anthrax vaccine candidate consisting of a protein subunit, mutant recombinant protective antigen SNKE167-ΔFF-315-E308D (mrPA), and liposome-embedded monophosphoryl lipid A (MPLA) adjuvant. Px563L has the potential to deliver an improved safety and immunogenicity profile relative to the currently licensed vaccine, which is produced from filtered B. anthracis culture supernatants. We conducted a Phase 1, double–blind, placebo–controlled, dose–escalation study in 54 healthy subjects to evaluate Px563L at 3 dose levels of mrPA (10, 50, and 80 mcg). For each dose level, 18 subjects were randomized in an 8:8:2 ratio to Px563L (mrPA with adjuvant), RPA563 (mrPA only) or placebo (saline). Each subject received an intramuscular (IM) injection on Day 0 and Day 28. Primary safety and immunogenicity analysis was conducted after all subjects completed the Day 70 visit, a duration deemed clinically relevant for post-exposure prophylaxis. Long-term safety was assessed through Day 393. Vaccinations with Px563L at all dose levels were well-tolerated. There were no serious adverse events or adverse events (AE) leading to early withdrawal. In all treatment groups, most AEs were due to injection site reactions, and all AEs at the 10 and 50 mcg dose levels were mild. For the primary immunogenicity endpoint (protective toxin neutralizing antibody 50% neutralization factor [TNA NF50]), titers started to increase significantly after the second administration of Px563L, from Day 35 through Day 70, with the geometric mean and lower bound of the 95% confidence interval exceeding 0.56, a threshold correlating with significant survival in animal models of anthrax exposure. In conclusion, Px563L, administered as two IM doses 28 days apart, was well-tolerated and elicited a protective antibody response starting at seven days after the second vaccination. These findings support the continued development of Px563L in a two-dose regimen for anthrax post-exposure prophylaxis. ClinicalTrials.gov identifier NCT02655549.

The COVID-19 pandemic offers an opportunity to examine public opinion regarding the allocation of scarce medical resources. In this conjoint experiment on a nationally representative sample of US adults, we examined how a range of patient characteristics affect respondents' willingness to allocate a ventilator between two patients with equal likelihood of short-term survival and how this differs by respondents' attributes. Respondents were 5.5 percentage points less likely to allocate a ventilator to a patient with a disability than to a nondisabled patient. Disability bias was correlated with older age cohorts and higher education levels of respondents. Liberal and moderate respondents were more likely to give a ventilator to Black and Asian patients than to White patients. Conservatives were much less likely to allocate a ventilator to transgender patients than to cisgender patients. These findings demonstrate the importance of bias mitigation and civil rights enforcement in health policy making, especially under conditions of scarcity.

The costs required to provide acute care for patients with serious burn injuries are significant. In the United States, these costs are often shared by patients. However, the impacts of preinjury finances on health-related quality of life (HRQL) have been poorly characterized. We hypothesized that lower income and public payers would be associated with poorer HRQL. Burn survivors with complete data for preinjury personal income and payer status were extracted from the longitudinal Burn Model System National Database. HRQL outcomes were measured with VR-12 scores at 6, 12, and 24 months postinjury. VR-12 scores were evaluated using generalized linear models, adjusting for potential confounders (eg, age, sex, self-identified race, burn injury severity). About 453 participants had complete data for income and payer status. More than one third of BMS participants earned less than $25,000/year (36%), 24% earned $25,000 to 49,000/year, 23% earned $50,000 to 99,000/year, 11% earned $100,000 to 149,000/year, 3% earned $150,000 to 199,000/year, and 4% earned more than $200,000/year. VR-12 mental component summary (MCS) and physical component summary (PCS) scores were highest for those who earned $150,000 to 199,000/year (55.8 and 55.8) and lowest for those who earned less than $25,000/year (49.0 and 46.4). After adjusting for demographics, payer, and burn severity, 12-month MCS and PCS and 24-month PCS scores were negatively associated with Medicare payer (P < .05). Low income was not significantly associated with lower VR-12 scores. There was a peaking relationship between HRQL and middle-class income, but this trend was not significant after adjusting for covariates. Public payers, particularly Medicare, were independently associated with poorer HRQL. The findings might be used to identify those at risk of financial toxicity for targeting assistance during rehabilitation.

Burn scar contracture (BSC) is a common pathological outcome following burn injuries, leading to limitations in range of motion (ROM) of affected joints and impairment in function. Despite a paucity of research addressing its efficacy, static splinting of affected joints is a common preventative practice. A survey of therapists performed 25 years ago showed a widely divergent practice of splinting during the acute burn injury. We undertook this study to determine the current practice of splinting during the index admission for burn injuries. This is a review of a subset of patients enrolled in the Burn Patient Acuity Demographics, Scar Contractures and Rehabilitation Treatment Related to Patient Outcome Study (ACT) database. ACT was an observational multicenter study conducted from 2010 to 2013. The most commonly splinted joints (elbow, wrist, knee, and ankle) and their seven motions were included. Variables included patients’ demographics, burn variables, rehabilitation treatment, and hospital course details. Univariate and multivariate analysis of factors related to splinting was performed. P < .05 was significant. Thirty percent of the study population (75 patients) underwent splinting during their hospitalization. Splinting was associated with larger burns and increased injury severity on the patient level and increased involvement with burns requiring grafting in the associated cutaneous functional unit (CFU) on the joint level. The requirement for skin grafting in both analyses remained independently related to splinting, with requirement for grafting in the associated CFU increasing the odds of splinting six times (OR = 6.0, 95% CI = 3.8–9.3, P < .001). On average, splinting was initiated about a third into the hospital length of stay (LOS, 35 ± 21% of LOS) and splints were worn for 50% (50 ± 26%) of the LOS. Joints were splinted for an average 15.1 ± 4.8 hours a day. The wrist was most frequently splinted joint being splinted with one third of wrists splinted (30.7%) while the knee was the least frequently splinted joint with 8.2% splinted. However, when splinted, the knee was splinted the most hours per day (17.6 ± 4.8 hours) and the ankle the least (14.4 ± 4.6 hours). Almost one third had splinting continued to discharge (20, 27%). The current practice of splinting, especially the initiation, hours of wear and duration of splinting following acute burn injury remains variable. Splinting is independently related to grafting, grafting in the joint CFU, larger CFU involvement and is more likely to occur around the time of surgery. A future study looking at splinting application and its outcomes is warranted.

Burn survivors experience barriers to returning to work. For those who do return to work, little is known regarding whether they achieve preinjury productivity (i.e., equivalent or gain in income compared to preinjury income). Identifying patients at risk of not achieving preinjury productivity is important for targeting services that support this population. They extracted occupational and income data through 24 months postinjury from the multicenter, longitudinal Burn Model System National Database. Annual income was reported in six groups: 199k. Participants were classified by change in income at each follow-up (i.e., gain, loss, and equivalent). Explanatory variables included demographics, injury characteristics, insurance payer, employment status, and job type. Multilevel, multivariable logistic regression was used to model return to productivity. Four hundred fifty-three participants provided complete income data at discharge and follow-up. Of the 302 participants employed preinjury, 180 (60%) returned to work within 24 months postinjury. Less than half (138) returned to productivity (46% of participants employed preinjury; 77% of those who returned to work). Characteristics associated with return to productivity included older age (median 46.9 vs 45.9 years, OR 1.03, P = .006), Hispanic ethnicity (24% vs 11%, OR 1.80, P = 0.041), burn size >20% TBSA (33.7% vs 33.0%, OR 2.09, P = 0.045), and postinjury employment (54% vs 26%, OR 3.41, P < 0.001). More than half of employed people living with burn injury experienced loss in productivity within 24 months postinjury. Even if they return to work, people living with burn injuries face challenges returning to productivity and may benefit from vocational rehabilitation and/or financial assistance.

Patient-reported outcomes are important for understanding recovery after burn injury, benchmarking service delivery and measuring the impact of interventions. Patient-Reported Outcomes Measurement Information System (PROMIS)-29 domains have been validated for use among diverse populations though not among burn survivors. The purpose of this study was to examine validity and reliability of PROMIS-29 scores in this population.The PROMIS-29 scores of physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles, and pain interference were evaluated for validity and reliability in adult burn survivors. Unidimensionality, floor and ceiling effects, internal consistency, and reliability were examined. Differential item functioning was used to examine bias with respect to demographic and injury characteristics. Correlations with measures of related constructs (Community Integration Questionnaire, Satisfaction with Life Scale, Post-Traumatic Stress Checklist-Civilian, and Veteran's Rand-12) and known-group differences were examined.Eight hundred and seventy-six burn survivors with moderate to severe injury from 6 months to 20 years postburn provided responses on PROMIS-29 domains. Participants' ages ranged from 18 years to 93 years at time of assessment; mean years since injury was 3.4. All PROMIS domain scores showed high internal consistency (Cronbach's α = 0.87-0.97). There was a large ceiling effect on ability to participate in social roles (39.7%) and physical function (43.3%). One-factor confirmatory factor analyses supported unidimensionality (all comparative fit indices0.95). We found no statistically significant bias (differential item functioning). Reliability was high (0.9) across trait levels for all domains except sleep, which reached moderate reliability (0.85). All known-group differences by demographic and clinical characteristics were in the hypothesized direction and magnitude except burn size categories.The results provide strong evidence for reliability and validity of PROMIS-29 domain scores among adult burn survivors. Reliability of the extreme scores could be increased and the ceiling effects reduced by administering PROMIS-43, which includes six items per domain, or by administering by computerized adaptive testing.Diagnostic Test or Criteria, level III.

People living with HIV and who receive antiretroviral therapy have a significantly improved lifespan, compared to the early days without therapy. Unfortunately, persisting viral replication in the lungs sustains chronic inflammation, which may cause pulmonary vascular dysfunction and ultimate life-threatening Pulmonary Hypertension (PH). The mechanisms involved in the progression of HIV and PH remain unclear. The study of HIV-PH is limited due to the lack of tractable animal models that recapitulate infection and pathobiological aspects of PH. On one hand, mice with humanized immune systems (hu-mice) are highly relevant to HIV research but their suitability for HIV-PH research deserves investigation. On another hand, the Hypoxia-Sugen is a well-established model for experimental PH that combines hypoxia with the VEGF antagonist SU5416. To test the suitability of hu-mice, we combined HIV with either SU5416 or hypoxia. Using right heart catheterization, we found that combining HIV+SU5416 exacerbated PH. HIV infection increases human pro-inflammatory cytokines in the lungs, compared to uninfected mice. Histopathological examinations showed pulmonary vascular inflammation with arterial muscularization in HIV-PH. We also found an increase in endothelial-monocyte activating polypeptide II (EMAP II) when combining HIV+SU5416. Therefore, combinations of HIV with SU5416 or hypoxia recapitulate PH in hu-mice, creating well-suited models for infectious mechanistic pulmonary vascular research in small animals.

Stroke severity is the most important predictor of post-stroke outcome. Most longitudinal cohort studies do not include direct and validated measures of stroke severity, yet these indicators may provide valuable information about post-stroke outcomes, as well as risk factor associations. In the Atherosclerosis Risk in Communities (ARIC) study, stroke severity data were retrospectively collected, and this paper outlines the procedures used and shares them as a model for assessment of stroke severity in other large epidemiologic studies. Trained physician abstractors, who were blinded to other clinical events, reviewed hospital charts of all definite/probable stroke events occurring in ARIC. In this analysis we included 1,198 ischemic stroke events occurring from ARIC baseline (1987–1989) through December 31, 2009. Stroke severity was categorized according to the National Institutes of Health Stroke Scale (NIHSS) score and classified into 5 levels: NIHSS ≤ 5 (minor), NIHSS 6–10 (mild), NIHSS 11–15 (moderate), NIHSS 16–20 (severe), and NIHSS > 20 (very severe). We assessed interrater reliability in a subgroup of 180 stroke events, reviewed independently by the lead abstraction physician and one of the four secondary physician abstractors. Interrater correlation coefficients for continuous NIHSS score as well as percentage of absolute agreement and Cohen Kappa Statistic for NIHSS categories were presented. Determination of stroke severity by the NIHSS, based on data abstracted from hospital charts, was possible for 97% of all ischemic stroke events. Median (25%-75%) NIHSS score was 5 (2–8). The distribution of NIHSS category was NIHSS ≤ 5 = 58.3%, NIHSS 6–10 = 24.5%, NIHSS 11–15 = 8.9%, NIHSS 16–20 = 4.7%, NIHSS > 20 = 3.6%. Overall agreement in the classification of severity by NIHSS category was present in 145/180 events (80.56%). Cohen’s simple Kappa statistic (95% CI) was 0.64 (0.55–0.74) and weighted Kappa was 0.79 (0.72–0.86). Mean (SD) NIHSS score was 5.84 (5.88), with a median score of 4 and range 0–31 for the lead reviewer (rater 1) and mean (SD) 6.16 (6.10), median 4.5 and range 0–36 in the second independent assessment (rater 2). There was a very high correlation between the scores reported in both assessments (Pearson r = 0.90). Based on our findings, we conclude that hospital chart-based retrospective assessment of stroke severity using the NIHSS is feasible and reliable.

The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) is a widely used measure for assessing the presence and severity of obsessive-compulsive disorder symptoms. The Yale-Brown Obsessive-Compulsive Scale-Second Edition (Y-BOCS-II) was developed, in part, to more comprehensively evaluate symptom severity, especially in extremely ill patients, and improve consistency in detecting and incorporating avoidance behaviors. We present 3 case studies that demonstrate the enhanced ability of the Y-BOCS-II to: (1) detect fluctuations in symptom severity among extremely ill patients, (2) systematically incorporate avoidance variables for more accurate ratings, and (3) maintain strong convergence with the Y-BOCS in assessing patients presenting with mild to moderate symptoms. In addition, we outline how to obtain both Y-BOCS and Y-BOCS-II scores within 1 administration by adding Y-BOCS item 4 to the Y-BOCS-II assessment, then "back-coding" the Y-BOCS-II ratings to Y-BOCS ratings and using Y-BOCS item 4 in place of Y-BOCS-II item 2. The use of this method allows for more robust data collection while providing comparability across the literature.

INTRODUCTION: Representativeness of research populations impacts the ability to extrapolate findings. The Burn Model System (BMS) National Database is one of the largest prospective, longitudinal, multi-center research repositories collecting patient-reported outcomes after burn injury.. OBJECTIVE: This study aimed to assess if the BMS Database is representative of the population that is eligible to participate. DESIGN: Data on adult burn survivors who were eligible for the BMS Database from 2015 to 2019 were analyzed. SETTING: N/A PARTICIPANTS: Burn survivors treated at BMS centers meeting eligibility criteria for the BMS Database. Eligibility for the database is based on burn size and receipt of autografting surgery. INTERVENTIONS: N/A MAIN OUTCOME MEASURE(S): Race, ethnicity, gender, and age were compared between individuals who did and did not enroll. Regression analysis examined the correlation between demographic characteristics and study enrollment.. Additional regression analysis examined the association between enrollment and the intersection of race, ethnicity, and gender. RESULTS: A total of 982 adult burn survivors were eligible for the BMS database during the study period. Of those who were eligible, 72.1% Enrolled and 27.9% were Not Enrolled. The Enrolled group was more female and younger compared to the Not Enrolled group. In regression analyses, Black/African American burn survivors were less likely and individuals identifying as female were more likely to enroll in the BMS Database. Further, when looking at groups by race and gender and ethnicity and gender, White men and women were more likely to enroll compared to Black/African American men and women and non-Hispanic/Latino men were more likely to enroll compared to Hispanic/Latino men. CONCLUSIONS: This study found differences in BMS Database enrollment by race, ethnicity, and gender. Further research is warranted to investigate causes for the disparities found in this study. Additionally, strategies are needed to improve enrollment to ensure future representativeness.

Pediatric burn injuries can alter the trajectory of the survivor’s entire life. Patient-centered outcome measures are helpful to assess unique physical and psychosocial needs and long-term recovery. This study aimed to develop a conceptual framework to measure pediatric burn outcomes in survivors aged 5 to 12 years as a part of the School-Aged Life Impact Burn Recovery Evaluation Computer Adaptive Test (SA-LIBRE5–12 CAT) development. This study conducted a systematic literature review guided by the WHO International Classification of Functioning—Child and Youth and domains in the American Burn Association/Shriners Hospitals for Children Burn Outcomes Questionnaire5–18. Interviews with eight parents and seven clinicians were conducted to identify important domains in child recovery. One clinician focus group with four clinicians was completed to identify gaps in the preliminary framework, and semiweekly expert consensus meetings were conducted with three experts to solidify the framework. Qualitative data were analyzed by grounded theory methodology. Three major thematic outcome domains emerged: 1) Physical Functioning: fine motor and upper extremity, gross motor and lower extremity, pain, skin symptoms, sleep and fatigue, and physical resilience; 2) Psychological Functioning: cognitive, behavioral, emotional, resilience, and body image; and 3) Family and Social Functioning: family relationships, and parental satisfaction, school, peer relations, and community participation. The framework will be used to develop item banks for a CAT-based assessment of school-aged children’s health and developmental outcomes, which will be designed for clinical and research use to optimize interventions, personalize care, and improve long-term health outcomes for burned children.

Background Comorbidity indices have been used to represent the overall medical complexity of patient populations in clinical research; however, it is not known how well they capture the comorbidities of patients with a stroke or brain injury admitted to inpatient rehabilitation facilities (IRFs). Objective To determine how well commonly used comorbidity indices capture the comorbidities of patients admitted to IRFs after a stroke or brain injury. Design Cross-sectional, retrospective study. Setting IRFs nationwide. Participants Adults from four impairment groups: (1) hemorrhagic stroke, (2) ischemic stroke, (3) nontraumatic brain injury (NTBI), and (4) traumatic brain injury (TBI). Main outcome measures International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes were extracted from the Uniform Data System for Medical Rehabilitation (UDSMR) for IRF discharges from October 1, 2015 to December 31, 2017. The percentage of discharges captured by Deyo-Charlson, Elixhauser, and Centers for Medicare and Medicaid Services (CMS) tiers was determined, as was the percentage of comorbidities captured. These measures were also compared with respect to their ability to capture chronic medical complexity by examining the percentage of codes captured after removal of codes deemed to represent hospital complications or sequela of the admission diagnosis. Results The percentage of discharges without at least one ICD-10-CM code captured by any index ranged from 0.3%-3.8%. The percentage of comorbidities with a prevalence exceeding 1% captured by at least one index ranged from 37.1%-43.6%. Chronic comorbidities were most likely to be captured by Elixhauser (40.7%-44.4%), followed by Deyo-Charlson (7.8%-9.6%), then CMS tiers (4.5%-6.9%). Existing comorbidity measures capture most IRF discharges related to a brain injury or stroke, whereas most medical comorbidities escape representation. Several common, functionally relevant diagnoses were not captured. Conclusion The use of comorbidity indices in the IRF neurologic injury population should account for the fact that these measures miss several common, important comorbidities.

To introduce a novel analytical approach for randomized controlled trials that are underpowered because of low participant enrollment or engagement.Reanalysis of data for 805 patients randomized as part of a pilot complex care intervention in 2015-2016 in a large delivery system. In the pilot randomized trial, only 64.6% of patients assigned to the intervention group participated.A case study and simulation. The "Distillation Method" capitalizes on the frequently observed correlation between the probability of subjects' participation or engagement in the intervention and the magnitude of benefit they experience. The novel method involves three stages: first, it uses baseline covariates to generate predicted probabilities of participation. Next, these are used to produce nested subsamples of the randomized intervention and control groups that are more concentrated with subjects who were likely to participate/engage. Finally, for the outcomes of interest, standard statistical methods are used to re-evaluate intervention effectiveness in these concentrated subsets.We assembled secondary data on patients who were randomized to the pilot intervention for one year prior to randomization and two follow-up years. Data included program enrollment status, membership data, demographics, utilization, costs, and clinical data.Using baseline covariates only, Generalized Boosted Regression Models predicting program enrollment performed well (AUC 0.884). We then distilled the full randomized sample to increasing levels of concentration and reanalyzed program outcomes. We found statistically significant differences in outpatient utilization and emergency department utilization (both follow-up years), and in total costs (follow-up year two only) at select levels of population concentration.By offering an internally valid analytic framework, the Distillation Method can increase the power to detect effects by redefining the estimand to subpopulations with higher enrollment probabilities and stronger average treatment effects while maintaining the original randomization.

The Burn Specific Health Scale-Brief (BSHS-B) is a commonly used burn-specific health outcome measure that includes 40 items across nine subscales. The objective of this study was to use both classical and modern psychometric methods to evaluate psychometric properties of the BSHS-B. Data were collected postburn injury by a multisite federally funded project tracking long-term outcomes. We examined dimensionality, local dependence, item fit, and functioning of response categories, homogeneity, and floor and ceiling effects. Items were fit to Item Response Theory models for evaluation. A total of 653 adults with burn injury completed the BSHS-B. Factor analyses supported unidimensionality for all subscales, but not for a total score based on all 40 items. All nine of the subscales had significant ceiling effects. Six item pairs displayed local dependence suggesting redundance and 11 items did not fit the Item Response Theory models. At least 15 items have too many response options. Results identified numerous psychometric issues with the BSHS-B. A single summary score should never be used for any purpose. Psychometric properties of the scale need to be improved by removing redundant items, reducing response categories, and modifying or deleting problematic items. Additional conceptual work is needed to, at a minimum, revise the work subscale and optimally to revisit and clearly define the constructs measured by all the subscales. Additional items are needed to address ceiling effects.

Objective/Background A small number of complex intracranial aneurysms are not amenable to direct clipping strategies or endovascular treatment. In these patients, parent artery sacrifice and bypass revascularization for aneurysm occlusion is an option. There are 3 strategies for parent artery sacrifice: trapping, complete occlusion of the inflow, and outflow segment; proximal occlusion of the inflow vessel; and distal occlusion of the outflow vessel(s). This study aimed to compare these techniques with regard to aneurysm occlusion rates. Methods We reviewed our database for cerebral revascularization before parent artery sacrifice to treat cerebral aneurysms. We assessed aneurysm occlusion rates 3 and 12 months after surgery, outcome, and postoperative aneurysm rupture. Results In total, 121 patients underwent parent artery sacrifice for complex aneurysms; 30% of the parent arteries were trapped, 58% proximally, and 12% distally occluded. Postoperative digital subtraction angiography revealed an aneurysm occlusion rate of 100% after trapping. Proximal occlusion led to early complete aneurysm occlusion in 71% of the cases, 21% occluded during follow-up. The complete occlusion rate was 96%, distal occlusion had an early aneurysm occlusion rate of 40%, 40% occluded during follow-up. Complete aneurysm occlusion rate was only 80%. All 3 techniques resulted in a volume reduction of more than 60% without a significant difference between the groups. The annual aneurysm rupture rate after distal parent artery sacrifice was 15%; there was no rupture after trapping or proximal parent artery sacrifice. Conclusions Trapping and proximal parent artery sacrifice seem to be superior to distal parent artery sacrifice regarding occlusion and rupture rates.

Family accommodation is a common, treatment-relevant construct related to obsessive-compulsive disorder (OCD) severity and treatment outcome. This initial study examined the nature, incidence, and clinical correlates of family accommodation in Chinese adults with OCD and their relative or person in a close relationship. One hundred four outpatients diagnosed with OCD completed self-report measures of obsessive-compulsive, anxiety, and depression symptoms. Additionally, the individuals with OCD and a relative completed a measure of family accommodation and impairment. Patient-reports of family accommodation were significantly correlated with OCD symptomology and severity. A multiple linear regression indicated that OCD symptomology was a significant predictor of family accommodation, but anxiety, stress, and depression were not. In addition, the current Chinese sample demonstrated greater levels of family accommodation than previous English-speaking samples. Potential explanations and implications of the high levels of reported family accommodation are discussed. Family accommodation could play a significant role in OCD development and/or maintenance in China. Future research considerations are discussed.

Background/objectives Patient education is important to families' ability to manage and cope with pediatric atopic dermatitis (AD). We evaluated whether an educational handbook could improve AD symptoms, caregiver confidence in AD management skills, and AD-related quality of life. Methods Caregivers of children with AD ages 1 month to 16 years were randomly assigned to the intervention arm (handbook in addition to standard AD management) or the control arm (standard management alone). Caregivers completed self-report outcome questionnaires prior to a clinical visit for AD and at 3-month follow-up. Results 175 caregivers completed questionnaires at baseline and follow-up. AD symptoms measured by the Patient-Oriented Eczema Measure (POEM) improved in both the handbook and control arms. However, the decrease in the mean POEM score in the handbook arm (-4.4, 95% CI [-5.8, -3.0]) did not differ from that in the control arm (-3.4, 95% CI [-4.8, -2.03]; P = .343). Change in quality of life did not differ between study arms. Among caregivers attending a new patient visit for AD, mean confidence scores (measured from 0 to 100) increased more in the handbook arm (67 [95% CI {60, 74}] to 83 [95% CI {77, 88}]) relative to the control arm (74 [95% CI {65, 82}] to 75 [95% CI {67, 83}]; P = .012). The majority of caregivers rated the handbook as helpful in managing the child's AD. Conclusions Despite an adequate sample size, the handbook did not improve AD symptoms more than standard management alone. The handbook improved confidence in management skills for families attending new patient visits for AD.

OBJECTIVE: To assess the association of burn size and community participation as measured by the LIBRE Profile. SUMMARY BACKGROUND DATA: Burn size is an established clinical predictor of survival following burn injury. It is often a factor in guiding decisions surrounding early medical interventions, however, literature is inconclusive on its relationship to quality of life outcomes. METHODS: This is a secondary data analysis of a cross-sectional survey of adult burn survivors. Self-reported data were collected between October 2014 and December 2015 from 601 burn survivors aged ≥18 years with ≥5% total body surface area (TBSA) or burns to critical areas. Sociodemographic characteristics were compared between participants with small burns (≤40% TBSA burned) and large burns (>40% TBSA burned). Ordinary least squares regression models examined associations between burn size and LIBRE Profile scale scores with adjustments for gender, current work status, burns to critical areas, and time since burn injury. RESULTS: The analytic sample comprised 562 participants with data available for burn size. 42% of respondents had large burns (>40% TBSA burned) and 58% reported smaller burns (TBSA ≤40%). In adjusted regression models, patients with large burns tended to score lower on the Social Activities and Work & Employment scales (p40% TBSA scored lower for several individual items in the Social Activities scale and one item in the Work & Employment scale (p

Characterizing the interactions that SARS-CoV-2 viral RNAs make with host cell proteins during infection can improve our understanding of viral RNA functions and the host innate immune response. Using RNA antisense purification and mass spectrometry, we identified up to 104 human proteins that directly and specifically bind to SARS-CoV-2 RNAs in infected human cells. We integrated the SARS-CoV-2 RNA interactome with changes in proteome abundance induced by viral infection and linked interactome proteins to cellular pathways relevant to SARS-CoV-2 infections. We demonstrated by genetic perturbation that cellular nucleic acid-binding protein (CNBP) and La-related protein 1 (LARP1), two of the most strongly enriched viral RNA binders, restrict SARS-CoV-2 replication in infected cells and provide a global map of their direct RNA contact sites. Pharmacological inhibition of three other RNA interactome members, PPIA, ATP1A1, and the ARP2/3 complex, reduced viral replication in two human cell lines. The identification of host dependency factors and defence strategies as presented in this work will improve the design of targeted therapeutics against SARS-CoV-2., Interactions between SARS-CoV-2 viral RNAs and host cell proteins during infection are evaluated to improve our understanding of viral RNA functions and the host innate immune response.

Background Pancreaticoduodenectomy is the only curative treatment option for patients with resectable ampullary adenocarcinoma (AA). Excellent disease free survival (DFS) can be achieved in patients with clear resection margins but it is poorly understood which patients are at increased risk of recurrence and hence would benefit from adjuvant chemotherapy. There is evolving evidence that the anatomical location of incomplete resection margins influences DFS in pancreatic adenocarcinoma. It is unknown if this also pertains to AA and therefore this study aimed to assess individual resection margin status and other predictors of DFS in AA. Material & methods Consecutive patients undergoing pancreaticoduodenectomy for AA at our institution from 1996 to 2017 were analysed. Pancreas neck, posterior and superior mesenteric vein margins were assessed individually. Cox proportional hazards modelling was used to identify predictors of 5-year DFS. Factors with p Results Analysis of 104 patients revealed median OS and DFS of 56 and 34 months, respectively. Predictors associated with worse DFS on multivariate analysis were T3-stage (HR 3.6, p = 0.048), N1 (HR 2.9, p = 0.01) and N2 -stage (HR 3.6, p = 0.006), R1 status at the posterior margin (HR 3.0, p = 0.009) and a visible mass on CT (HR 2.0, p = 0.039). Conclusion Routine histopathological assessment of individual resection margins may aid in predicting recurrence of AA. Future studies to assess if routine mesopancreas excision during pancreaticoduodenectomy can reduce the incidence of R1 status at the posterior margin are warranted.

Anxiety disorders affect up to 50% of individuals with autism spectrum disorder (ASD) and are significantly impairing to the person affected, as well as to their loved ones. Cognitive-behavioral therapy (CBT) has been established as the gold-standard treatment for anxiety disorders among typically developing youth and adults, and demonstrates similar efficacy among youth with high-functioning autism (HFA). Many CBT interventions utilize a “full-package” treatment approach to treat co-occurring anxiety in youth with ASD. However, these service delivery systems are often therapist-intensive, costly, and impractical, thereby compromising full engagement and treatment adherence. This paper describes the design, rationale, and methodology of a study examining stepped-care CBT for youth with HFA and co-occurring anxiety – a clinical trial examining the efficacy of low-intensity, parent-led CBT as the first line of treatment and utilizing a more intensive, therapist-led intervention for nonresponders. The study will evaluate the potential benefits of stepped-care and parent-led therapist-assisted interventions, predictors of treatment response, and the economic value of using a stepped-care model. Implications for practice will be discussed.

To date, no large population studies compare left and right middle cerebral artery (MCA) strokes and corresponding patient performance in acute rehabilitation as measured by the Functional Independence Measure (FIM).To compare granular performance data using the six FIM subcategories between left and right MCA territory strokes. This may foster development of individualized rehabilitation programs and affect rehabilitation policy based on phenotypic variations.Retrospective cohort study.Inpatient rehabilitation facilities, using Uniform Data System for Medical Rehabilitation data from 2015 to 2017.Individuals with MCA strokes admitted to inpatient rehabilitation facilities (n = 38 812).Mean FIM efficiency and FIM gain within the six FIM subcategories (self-care, sphincter control, transfers, locomotion, communication, and social cognition) were compared between left and right MCA strokes. All were stratified by admission FIM severity categories (40, 40-80,80). The study also examined length of stay and percentage discharged to home.Mean FIM efficiency was significantly higher for left MCA strokes compared to right MCA strokes. Left MCA strokes with admission FIM40 and 40-80 had significantly higher FIM efficiencies within the majority of FIM subcategories. However, left and right MCA strokes with admission FIM 80 did not display any significant differences. Overall, patients with left MCA strokes were discharged to home at a significantly higher percentage. Patients with left MCA strokes with admission FIM 40-80 had on average a 2-day shorter length of stay than those with right MCA strokes.Overall, patients with left MCA ischemic strokes had shorter length of stays, higher FIM efficiencies, and larger FIM gains than those with right MCA strokes. These results allow clinicians to counsel patients regarding functional gains based on diagnosis and to tailor rehabilitation programs to impairments encountered in left and right MCA territories. Including laterality of stroke and admission functional status would also improve algorithms for determining reimbursement.

Background The PEPITES (Peanut EPIT Efficacy and Safety) trial, a 12-month randomized controlled study of children with peanut allergy and 4 to 11 years old, previously reported the safety and efficacy of epicutaneous immunotherapy (EPIT) for peanut allergy (250 μg, daily epicutaneous peanut protein; DBV712 250 μg). Objective We sought to assess interim safety and efficacy of an additional 2 years of EPIT from the ongoing (5-year treatment) PEOPLE (PEPITES Open-Label Extension) study. Methods Subjects who completed PEPITES were offered enrollment in PEOPLE. Following an additional 2 years of daily DBV712 250 μg, subjects who had received DBV712 250 μg in PEPITES underwent month-36 double-blind, placebo-controlled food challenge with an optional month-38 sustained unresponsiveness assessment. Results Of 213 eligible subjects who had received DBV712 250 μg in PEPITES, 198 (93%) entered PEOPLE, of whom 141 (71%) had assessable double-blind, placebo-controlled food challenge at month 36. At month 36, 51.8% of subjects (73 of 141) reached an eliciting dose of ≥1000 mg, compared with 40.4% (57 of 141) at month 12; 75.9% (107 of 141) demonstrated increased eliciting dose compared with baseline; and 13.5% (19 of 141) tolerated the full double-blind, placebo-controlled food challenge of 5444 mg. Median cumulative reactive dose increased from 144 to 944 mg. Eighteen subjects underwent an optional sustained unresponsiveness assessment; 14 of those (77.8%) maintained an eliciting dose of ≥1000 mg at month 38. Local patch-site skin reactions were common but decreased over time. There was no treatment-related epinephrine use in years 2 or 3. Compliance was high (96.9%), and withdrawals due to treatment-related adverse events were low (1%). Conclusions These results demonstrate that daily EPIT treatment for peanut allergy beyond 1 year leads to continued response from a well-tolerated, simple-to-use regimen.

Objective Postpartum depression (PPD) remains an understudied research area despite its high prevalence. The goal of this study is to develop an ontology to aid in the identification of patients with PPD and to enable future analyses with electronic health record (EHR) data. Methods We used Protégé-OWL to construct a postpartum depression ontology (PDO) of relevant comorbidities, symptoms, treatments, and other items pertinent to the study and treatment of PPD. Results The PDO identifies and visualizes the risk factor status of variables for PPD, including comorbidities, confounders, symptoms, and treatments. The PDO includes 734 classes, 13 object properties, and 4,844 individuals. We also linked known and potential risk factors to their respective codes in the International Classification of Diseases versions 9 and 10 that would be useful in structured EHR data analyses. The representation and usefulness of the PDO was assessed using a task-based patient case study approach, involving 10 PPD case studies. Final evaluation of the ontology yielded 86.4% coverage of PPD symptoms, treatments, and risk factors. This demonstrates strong coverage of the PDO for the PPD domain. Conclusion The PDO will enable future researchers to study PPD using EHR data as it contains important information with regard to structured (e.g., billing codes) and unstructured data (e.g., synonyms of symptoms not coded in EHRs). The PDO is publicly available through the National Center for Biomedical Ontology (NCBO) BioPortal ( https://bioportal.bioontology.org/ontologies/PARTUMDO ) which will enable other informaticists to utilize the PDO to study PPD in other populations.

Sleep may play a role in overweight and obesity in adolescents. The objective of this study is to investigate the relationships between sleep duration and timing and overweight and obesity status in adolescents, with a special emphasis on weekday–weekend difference in sleep characteristics as well as sex-specific relationships. We examined 1,254 U.S. adolescents (12–17 years) self-reported sleep duration, timing, weekday–weekend differences in duration and timing in relation to overweight and obesity. We found an inverse association between sleep duration and overweight and obesity. Compared to 8–9 h of sleep, short sleep (

Health Care as an Ongoing Policy Project The United States lags behind peer countries on key health outcomes, and the pandemic has highlighted weaknesses of U.S. health care. Though Americans have ...

Failing the Test Tragically, the United States, unable to match other countries’ pandemic response, has tallied the most Covid-19 cases and deaths in the world. Why has the U.S. response been so in...

As the opioid epidemic continues across the United States, law enforcement K9s (LEK9s) are at increased risk of accidental exposure and overdose. This study evaluated a novel training program teaching handlers to administer naloxone to their LEK9 in the event of an overdose. Seventy-five LEK9 handlers from a governmental agency attended a naloxone training session. A presurvey given to the handlers evaluated their knowledge of opioid overdose in LEK9s and their confidence administering naloxone. Officers were educated via a PowerPoint presentation about naloxone and how to administer it to their LEK9. A postsurvey evaluated changes in their knowledge and confidence as a result of the presentation. Sixty-two presurveys and 47 postsurveys were completed. Nearly all handlers had never given their LEK9 an intramuscular or intranasal injection. Most handlers were not comfortable monitoring their LEK9’s vital signs for an opioid overdose. After the training, handlers demonstrated a mild increase in comfort level administering intramuscular and intranasal naloxone (15 and 14% increase, respectively). Comfort level monitoring vital signs and symptoms of an opioid overdose increased 38 and 32%, respectively. Handlers may not be fully prepared to assess and treat their LEK9 and may benefit from a targeted training program teaching them to administer naloxone.

OBJECTIVES: The aim of this study was to examine potential racial/ethnic disparities in community integration for the 2 yrs after burn injury. DESIGN: A sample of 1773 adults with burn injury from the Burn Model Systems database was used with data on community integration collected at discharge (preinjury recall), 6, 12, and 24 mos after discharge. METHODS: Four sets of hierarchal linear models determined the most appropriate model for understanding racial/ethnic differences in Community Integration Questionnaire trajectories over time. RESULTS: Data indicated a decrease in community integration between discharge and 6 mos, a slight increase between 6 mos and 1 yr, and then a plateau between 1 and 2 yrs. White individuals had higher community integration score trajectories over time than black (b = 0.53, P < 0.001) and Hispanic (b = 0.58, P < 0.001) individuals, and community integration scores were similar between black and Hispanic individuals (b = −0.05, P = 0.788). These racial/ethnic disparities remained after accounting for age, sex, total burned surface area, number of days in rehabilitation, and active range of motion deficits. CONCLUSIONS: Additional rehabilitation resources should be targeted to helping black and Hispanic individuals integrate back into their communities after burn injury.

Background Unanticipated hospital admission is regarded as a measure of adverse perioperative patient care. However, previously published studies for risk prediction after ambulatory procedures are sparse compared to those examining readmission after inpatient surgery. We aimed to evaluate the incidence and reasons for unplanned admission after ambulatory surgery and develop a prediction tool for preoperative risk assessment. Methods This retrospective cohort study included adult patients undergoing ambulatory, noncardiac procedures under anesthesia care at 2 tertiary care centers in Massachusetts, United States, between 2007 and 2017 as well as all hospitals and ambulatory surgery centers in New York State, United States, in 2014. The primary outcome was unplanned hospital admission within 30 days after discharge. We created a prediction tool (the PREdicting admission after Outpatient Procedures [PREOP] score) using stepwise backward regression analysis to predict unplanned hospital admission, based on criteria used by the Centers for Medicare & Medicaid Services, within 30 days after surgery in the Massachusetts hospital network registry. Model predictors included patient demographics, comorbidities, and procedural factors. We validated the score externally in the New York state registry. Reasons for unplanned admission were assessed. Results A total of 170,983 patients were included in the Massachusetts hospital network registry and 1,232,788 in the New York state registry. Among those, the observed rate of unplanned admission was 2.0% (3504) and 1.7% (20,622), respectively. The prediction model showed good discrimination in the training set with C-statistic of 0.77 (95% confidence interval [CI], 0.77-0.78) and satisfactory discrimination in the validation set with C-statistic of 0.71 (95% CI, 0.70-0.71). The risk of unplanned admission varied widely from 0.4% (95% CI, 0.3-0.4) among patients whose calculated PREOP scores were in the first percentile to 21.3% (95% CI, 20.0-22.5) among patients whose scores were in the 99th percentile. Predictions were well calibrated with an overall ratio of observed-to-expected events of 99.97% (95% CI, 96.3-103.6) in the training and 92.6% (95% CI, 88.8-96.4) in the external validation set. Unplanned admissions were most often related to malignancy, nonsurgical site infections, and surgical complications. Conclusions We present an instrument for prediction of unplanned 30-day admission after ambulatory procedures under anesthesia care validated in a statewide cohort comprising academic and nonacademic hospitals as well as ambulatory surgery centers. The instrument may be useful in identifying patients at high risk for 30-day unplanned hospital admission and may be used for benchmarking hospitals, ambulatory surgery centers, and practitioners.