University of North Carolina Hospitals

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    95038 research outputs found

    Development of the binaural intelligibility level difference for speech-in-speech recognition

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    This study aimed to characterize maturation of the binaural intelligibility level difference (BILD) for school-age children in the context of speech-in-speech recognition. Children (5-17 years) and adults completed an adaptive, open-set sentence recognition task in a two-talker masker in two binaural conditions: (1) target and masker speech in-phase across the two ears, and (2) target speech presented 180° out-of-phase across the two ears and masker speech presented in-phase. Estimates of the BILD, computed as the difference score between the two binaural conditions, were mature by ten years of age, consistent with previous data on the BILD for speech-in-noise recognition

    POLICY AND PERCEPTION: INVESTIGATING NORTH CAROLINA’S READING POLICY, THE SCIENCE OF READING, AND TEACHERS’ INSTRUCTIONAL PRACTICES

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    Stephen Rayfield: Policy and Perception: Investigating North Carolina's Reading Policy, the Science of Reading, and Teachers’ Instructional Practices Literacy education policy in North Carolina has had many iterations over the last 30 years, and the rise of the most recent round of policies have taken their place in North Carolina 's education policy history. Following the pandemic, specifically 2021, N.C. has begun (through Senate Bill 387 / SL 2021-8) to take note of other States’ initiatives around the Science of Reading and programs that have engendered profound shifts in pedagogical approaches. In North Carolina, that is the convergence of the Science of Reading framework and the Language Essentials for Teachers of Reading and Spelling (LETRS). The ongoing discourse around how students learn to read has not suddenly been resolved or agreed upon; however, different conversations are happening now surrounding the efficacy of instructional methodologies. This study exists because of what we know from the history of an ever-changing education policy landscape in North Carolina and the critical need to investigate the practical implications of the commitment to policy that is grounded in the Science of Reading and the engagement with LETRS on teacher instruction and perceived student achievement. As such, this study endeavors to undertake an exploration of the interplay between the spread and diffusion of the Science of Reading, LETRS, and their impact within educational contexts through the lens of qualitative inquiry. This study will look into the Science of Reading and the Statewide implementation of the Language Essentials for Teachers of Reading and Spelling (LETRS) framework. Within the context of LETRS, the core of the Science of Reading will be further isolated to examine its impact on teacher instruction, school instructional practices, and broad student achievement within a sampling of North Carolina schools.Doctor of Educatio

    Associations between pain reactivity to worse sleep and health outcomes.

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    Sleep and pain are co-occurring issues in adulthood. "Pain reactivity to worse sleep" refers to person-specific changes in daily pain following nights of shorter-than-usual sleep duration or poorer-than-usual sleep quality. We examined the cross-sectional and longitudinal relationships between sleep-related pain reactivity with psychological distress and the number of chronic conditions.Data were obtained from the Work, Family, and Health Study, which collected data from workers (n = 311; Mage = 41.38 years), who completed eight days of daily diary. We controlled for sociodemographic and health covariates in a series of multilevel structural equation models and growth curve models in Mplus. Sensitivity analyses adjusted for sleep and pain medications and stratified analyses by age.Those with higher pain severity reactivity to shorter sleep duration (B = 0.54, p < .001) and higher pain severity reactivity to poorer sleep quality (B = 0.58, p < .001) had more concurrent distress. In the growth curve models, pain reactivity to worse sleep was not associated with a change in distress or the number of chronic conditions. After controlling for sleep and pain medication use, higher pain reactivity to poorer sleep quality was associated with more concurrent distress, and contrary to hypotheses, higher pain location reactivity to poorer sleep quality was associated with a decrease in distress and fewer chronic conditions over time.Higher pain reactivity to worse sleep was associated with more concurrent distress but not distress over time or risk of chronic conditions. Future directions are to examine the influence of pain reactivity to worse sleep in larger and more diverse samples across longer follow-up

    Pooled analysis of trastuzumab deruxtecan retreatment after recovery from grade 1 interstitial lung disease/pneumonitis

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    PURPOSE: Trastuzumab deruxtecan (T-DXd), an antibody-drug conjugate treatment for multiple solid tumors, carries risk of interstitial lung disease/pneumonitis (ILD). Management guidelines generally mandate interrupting T-DXd treatment for grade 1 ILD, with possible retreatment following resolution of imaging findings. This pooled analysis examined T-DXd retreatment duration and ILD recurrence following recovery from grade 1 ILD. PATIENTS AND METHODS: Data were pooled from 9 clinical trials of patients with various HER2-positive, HER2-low, or HER2 (ERBB2)-mutant solid tumors treated with T-DXd (5.4-8.0 mg/kg). ILD events were reported and graded by investigators and confirmed as drug-related by an independent ILD adjudication committee. Patients who recovered from a first investigator-assessed grade 1 and adjudication committee-confirmed drug-related ILD event (ILD1) could receive T-DXd retreatment. Patients were evaluated until disease progression or data cutoff. RESULTS: Among 2145 pooled patients, 9% (193/2145) had grade 1 ILD1, of which 23.3% (45/193) were retreated with T-DXd. Median retreatment duration was 85 days (range, 1-848); 17.8% (8/45) of patients received T-DXd retreatment for ≥1 year. ILD recurrence (ILD2) occurred in 33.3% (15/45) of retreated patients; median time to ILD2 from T-DXd retreatment was 64 days (range, 22-391) and were low-grade events (grade 1, n=6; grade 2, n=9; no grade ≥3 or fatal events). Reasons for T-DXd retreatment discontinuation were disease progression (33.3% [15/45]); ILD recurrence (20% [9/45]); non-ILD adverse events (17.8% [8/45]); physician's decision (4.4% [2/45]). At the analysis cutoff, 24.4% (11/45) of retreated patients were still receiving treatment, and most patients with ILD2 (60% [9/15]) had recovered with/without sequelae. CONCLUSIONS: This first large-scale pooled analysis demonstrates the safety of T-DXd retreatment after recovery from grade 1 ILD. ILD recurred in one-third of patients; all recurrence events were grade 1/2 and manageable using existing treatment guidelines. T-DXd retreatment following resolution of grade 1 drug-related ILD has potential to maximize therapeutic benefit

    Infectious Complications Following CD30 Chimeric Antigen Receptor T-cell Therapy in Adults

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    Infections are increasingly recognized as a complication of chimeric antigen receptor T-cell (CAR-T) therapy however the incidence of infections after non-CD19 targeted CAR-T is not yet known. We report, for the first time, infectious complications after CD30 CAR T-cell treatment for patients with Hodgkin lymphoma and peripheral T-cell lymphoma. We retrospectively evaluated all 64 adult patients with relapsed/refractory CD30+ lymphomas who received anti-CD30 CAR T-cells at a single institution between 2016–2021. We assessed microbiologically confirmed infections within 1 year after cell infusion, censoring for relapse. We calculated infection density (total infections per 100 patient-days-at-risk), and cumulative incidence of infection divided into time periods postinfusion (days 0–28, 29–90, and 91–365). We compared infectious outcomes to a concurrent cohort of CD19 CAR-T recipients (n = 50) at the same institution. Infection density in the first year after CD30 CAR T-cell infusion was 0.131 per 100 patient-days-at-risk, with 17 patients developing 19 total infections including 15 mild, 3 moderate, and 1 severe infection (1-year cumulative incidence of 32%; 95% confidence interval [CI], 19–47]). Infections were primarily viral (30%; 95% CI, 17–44) and most common early after infusion. Far fewer infections were bacterial in CD30 CAR-T recipients (4.9%; 95% CI, 1.3–13), in contrast to the CD19 cohort in which bacterial infections predominated and were more severe. Microbiologically confirmed infections, primarily with respiratory viruses, were most common in the first 28 days after CD30 CAR-T infusion and most were mild. Our findings may have implications for antimicrobial prophylaxis guidelines after CD30 CAR-T therapy. Most infections after CD30 CAR-T infusion were mild compared to infections in a concurrent cohort of CD19 CAR-T recipients at the same institution. Viral infections were more common in the first 28 days after CD30 CAR-T, but bacterial infections predominated early after CD19 CAR-T

    SPIRIT 2025 statement: updated guideline for protocols of randomised trials

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    IMPORTANCE: The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. OBJECTIVE: To systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial. DESIGN: We completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting. FINDINGS: Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrolment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. CONCLUSIONS AND RELEVANCE: Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators, and other reviewers

    Acute Febrile Illness Associated with an Emerging Dengue 4 GIIb Variant Causing Epidemic in León, Nicaragua 2022

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    Historically, DENV-4 has been rarely associated with epidemics and has been less well-studied than DENV-1 to -3. Epidemic dengue struck several South and Central American countries in 2022, with Nicaragua reporting the highest incidence. In an acute febrile illness (AFI) cohort enrolled from June to September 2022, 58 (34%) of 172 patients had PCR-confirmed dengue, of which 46 (79%) were serotyped as DENV-4. In this cohort, acute dengue, as a proportion of AFI, increased from 8% in June to a peak of 58% in August. Genome sequencing and phylogenetic analysis identified a lineage of DENV-4 Genotype IIb (GIIb) with six amino acid substitutions on the surface-exposed regions of the envelope (E) protein as compared to a reference sequence from 2005. Indeed, two of these mutations appear to be novel and located at G172E or near N174K, an antigenic epitope on domain I. Most (90%, 43/48) DENV-4 patients had pre-existing DENV IgG (secondary dengue), at the acute phase. Secondary dengue was associated with the male sex (prevalence ratio (PR)), 6.88) and being younger than 11 years of age (PR, 8.38). Further analysis showed no association between past Zika exposure and DENV-4 acute illness in older subjects (≥12 years of age). In conclusion, our study describes an epidemic of DENV-4 in León, Nicaragua, associated with a novel lineage of genotype GIIb, which contains two amino acid changes not observed in DENV-4 before 2022

    HIV Status and COVID-19 Treatment Disparities in the US National Clinical Cohort Collaborative

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    In this retrospective N3C cohort study, persons with HIV and COVID-19 infection had significantly higher odds of receiving COVID-19 therapeutics than those without HIV. However, significant racial/ethnic inequities appeared, with a lower prevalence of COVID-19 therapeutics receipt among racial/ethnic minorities

    Psychology of Planning

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    Planning has been studied in different fields of psychology, including cognitive, developmental, personality, social, and work and organizational research. This article looks at the planning process through the lens of motivation science, and asks the question, What kind of planning can help people reach their goals? We focus on the strategy of making if-then plans (also known as forming implementation intentions). We discuss what kinds of cognitive performance can be enhanced by if-then planning (e.g., attention control, prospective memory, executive functions, and decision making), and whether if-then planning may also benefit people's emotion control, their desired behavior change, and their pending social interactions. We point to the positive impacts of making if-then plans on thinking, feeling, and acting, and we list moderators pertaining to sample characteristics and features of the underlying goals and of the if-then plans themselves. Finally, the underlying processes of if-then planning effects are delineated in the hope of better understanding what kind of if-then planning might work best in promoting flexible but tenacious goal pursuit

    Sex Differences, Menses‐Related Symptoms and Menopause in Disorders of Gut–Brain Interaction

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    BACKGROUND: Disorders of gut-brain interaction (DGBI) predominate in women, but little is known about sex differences in menses-related or menopause symptoms. METHODS: Using data from the Rome Foundation Global Epidemiology Survey, we assessed Rome IV DGBI symptoms in individuals in 26 countries who met criteria for ≥ 1 of 5 DGBI: irritable bowel syndrome (IBS), functional dyspepsia (FD), functional constipation (FC), functional diarrhea (FDr), or functional bloating (FB). Participants included pre- and post-menopausal women with DGBI and age-matched men. Odds ratios estimated sex and age differences for symptom by sex or pre- vs. post-menopause in logistic regression; standardized mean difference (SMD) provided effect sizes. KEY RESULTS: 14,570 participants met criteria for ≥ 1 of the 5 DGBI. Women exceeded men in most symptoms. In FD, women stopped eating due to early satiety more than men (11.1 vs. 8.9 days/month, SMD 0.21). Symptoms were generally increased in premenopausal women and younger men compared to older counterparts; however, only premenopausal IBS, FD, and FC women reported increased constipation-associated symptoms. Compared to premenopausal women, postmenopausal women had increased accidental stool leakage in IBS and FDr, and increased digital manual maneuvers in FC (18% vs. 25% frequency, SMD -0.25). IBS and FD had the most menses-associated symptoms. CONCLUSIONS AND INFERENCES: Women had higher symptom frequency across the 5 DGBI compared to men. Our findings suggest that premenopausal women have greater visceral perception than postmenopausal women, although increased outlet symptoms in postmenopausal women indicate greater anorectal/pelvic dysfunction. While age alone has some influence on symptoms, female sex hormones may also increase visceral perception

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