Feasibility, acceptability, and efficacy of a positive emotion regulation intervention to promote resilience for healthcare workers during the COVID-19 pandemic: A randomized controlled trial.

INTRODUCTION: Burnout poses a substantial, ongoing threat to healthcare worker (HCW) wellbeing and to the delivery of safe, quality healthcare. While systemic and organization-level changes in healthcare are critically important, HCWs also need individual-level skills to promote resilience. The objective of this trial is to test feasibility, acceptability, and efficacy of PARK, an online self-guided positive affect regulation intervention, in a sample of healthcare workers during the COVID-19 pandemic. DESIGN AND METHODS: In the context of the unprecedented rise in burnout during the COVID-19 pandemic, we conducted a randomized waitlist-controlled trial of the Positive Affect Regulation sKills (PARK) program-a five-week, online, self-guided coping skills intervention nested within an ongoing cohort of HCWs. N = 554 healthcare workers were randomly assigned to receive the intervention immediately or to receive the intervention after approximately 12 weeks. Outcomes included change in burnout, emotional wellbeing (positive affect, meaning and purpose, depression, anxiety) and sleep over approximately 12 weeks. Analyses included mixed-effects linear regression models comparing change over time in outcomes between intervention and control conditions. RESULTS: One third (n = 554) of the participants in the cohort of HCWs consented to participate and enrolled in PARK in April 2022. Compared to those who did not enroll, participants in the trial reported higher burnout, poorer emotional wellbeing, and poorer sleep at baseline (April, 2022; all ps < .05). Intent-to-treat analyses showed that participants randomly assigned to the intervention immediately (PARK-Now) improved significantly on anxiety (within-group change on PROMIS T-score = -0.63; p = .003) whereas those in the waitlist (PARK-Later) did not (within group T-score change 0.04, p = 0.90). The between-group difference in change, however, was not statistically significant (B = -0.67 p = 0.10). None of the other wellbeing outcomes changed significantly in the intervention group compared to the waitlist. Additional as-treated analyses indicated that those participants who completed all 5 of the weekly online lessons (N = 52; 9.4%) improved significantly more on the primary outcome of positive affect compared to those who enrolled in PARK but completed zero lessons (n = 237; 42.8%; B = 2.85; p = .0001). CONCLUSIONS: Online self-guided coping skills interventions like PARK can be effective in targeted samples and future work will focus on adaptations to increase engagement and tailor PARK for HCWs who could most benefit.

Medical Complexity, Language Use, and Outcomes in the Pediatric ICU.

OBJECTIVES: To determine whether use of a language other than English (LOE) would be associated with medical complexity, and whether medical complexity and LOE together would be associated with worse clinical outcomes. METHODS: The primary outcome of this single-site retrospective cohort study of PICU encounters from September 1, 2017, through August 31, 2022 was an association between LOE and medical complexity. Univariable and multivariable analyses were performed between demographic factors and medical complexity, both for unique patients and for all encounters. We investigated outcomes of initial illness severity (using Pediatric Logistic Organ Dysfunction-2), length of stay (LOS), days without mechanical ventilation or organ dysfunction using a mixed effects regression model, controlling for age, sex, race and ethnicity, and insurance status. RESULTS: There were 6802 patients and 10 011 encounters. In multivariable analysis for all encounters, Spanish use (adjusted odds ratio [aOR], 1.29; 95% confidence interval [CI], 1.11-1.49) and language other than English or Spanish (LOES) (aOR, 1.36; 95% CI, 1.02-1.80) were associated with medical complexity. Among unique patients, there remained an association between use of Spanish and medical complexity in multivariable analysis (aOR, 1.26; 95% CI, 1.05-1.52) but not between LOES and medical complexity (aOR, 1.30; 95% CI, 0.92-1.83). Children with medical complexity (CMC) who used an LOES had fewer organ dysfunction-free days (P = .003), PICU LOS was 1.53 times longer (P = .01), and hospital LOS was 1.45 times longer (P = .01) compared with CMC who used English. CONCLUSIONS: Use of an LOE was independently associated with medical complexity. CMC who used an LOES had a longer LOS.

Do We Become More Lonely With Age? A Coordinated Data Analysis of Nine Longitudinal Studies.

Loneliness is a pervasive experience with adverse impacts on health and well-being. Despite its significance, notable gaps impede a full understanding of how loneliness changes across the adult life span and what factors influence these changes. To address this, we conducted a coordinated data analysis of nine longitudinal studies encompassing 128,118 participants ages 13 to 103 from over 20 countries. Using harmonized variables and models, we examined loneliness trajectories and predictors. Analyses revealed that loneliness follows a U-shaped curve, decreasing from young adulthood to midlife and increasing in older adulthood. These patterns were consistent across studies. Several baseline factors (i.e., sex, marital status, physical function, education) were linked to loneliness levels, but few moderated the loneliness trajectories. These findings highlight the dynamic nature of loneliness and underscore the need for targeted interventions to reduce social disparities throughout adulthood.

Randomized controlled trial of a positive emotion regulation intervention to reduce stress in family caregivers of individuals with Alzheimer's disease: protocol and design for the LEAF 2.0 study.

BACKGROUND: Caring for a loved one with Alzheimer's disease can be stressful, resulting in poorer emotional and physical health among family caregivers. Although supportive resources for caregivers are available, distance, caregiver health, and the daily demands of caregiving are barriers to access. Based on research demonstrating the importance of positive emotions in coping with stress, our previous trial showed that dementia caregivers who participated in facilitated, web-based delivery of a positive emotion regulation intervention called LEAF (Life Enhancing Activities for Family caregivers) experienced increased positive emotion and decreased depression and anxiety. Building on this evidence, the LEAF 2.0 study aims to test whether web-based, self-guided delivery can confer similar benefits for caregivers of individuals with Alzheimer's disease. METHODS: This paper presents the design and methods for LEAF 2.0, a 3-arm web-based randomized controlled trial (N = 500) in which family caregivers of patients with Alzheimer's disease (AD) are randomized to (1) the LEAF intervention facilitated remotely via the web (N = 200), (2) the LEAF intervention self-guided online (N = 200), or (3) an emotion reporting control (N = 100), which then crosses over to the intervention after approximately 6 months, half to the facilitated arm and half to the self-guided arm. We aim to (1) compare the effect of the facilitated and self-guided LEAF positive emotion interventions to an emotion reporting control condition on AD caregiver well-being (positive emotion, depression, anxiety, and perceived stress) and secondary outcomes (caregiving burden, caregiving self-efficacy, positive aspects of caregiving, quality of care, and AD patient quality of life); (2) assess whether effects are mediated by improvements in positive emotion or other aspects of caregiver well-being; and (3) test whether caregiver age or gender or the care recipient's dementia severity moderates the effects of the intervention. DISCUSSION: If demonstrated to be effective, LEAF can be widely disseminated and ultimately have a significant impact on the stress experienced by AD caregivers and the well-being of people living with Alzheimer's disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT03610698.

Surgeon views on firearm safety counseling in clinical practice: A cross-sectional survey.

BACKGROUND: Firearms are commonplace in the United States, and one proposed strategy to decrease risk of firearm injury is to have physicians counsel their patients about safe firearm ownership. Current rates of firearm safety counseling by surgeons who care for injured people are unknown. METHODS: This study used an anonymous cross-sectional survey derived from previously published survey instruments and was piloted (n = 13) at the annual meeting of the American Association for the Surgery of Trauma (2022). The finalized survey was distributed using a quick response code during two sessions at the 2022 American College of Surgeons Clinical Congress. Eligible participants included the surgeons and surgical trainees who attended these sessions. RESULTS: One hundred fourteen individuals completed the survey (20% response rate), and a majority were male (n = 71 [62.3%]), attending surgeons (n = 108 [94.7%]), and specialized in acute care surgery (n = 72 [63.2%]). Few participants (n = 43 [37.7%]) reported counseling patients on firearm safety as part of their routine clinical practice; however, the majority (n = 102 [89.5%]) believed that surgeons should provide firearm safety counseling. Counseling rates did not vary significantly by age, sex, surgical specialty, or region of practice, but attitudes toward counseling did differ by firearm safety counseling practices ( p = 0.03) and region of practice (0.04). Noted barriers to counseling included lack of time (n = 47 [41.2%]), perceived lack of training (n = 43 [37.7%]), and lack of firearm knowledge/experience (n = 36 [31.6%]). CONCLUSION: Most surgeon respondents did not provide firearm safety counseling to their patients despite the fact the majority believed they should. This suggests that counseling interventions that do not solely rely on surgeons for implementation could increase the number of patients who receive firearm safety guidance during clinical encounters. LEVEL OF EVIDENCE: Prognostic and Epidemiological; Level III.

Associations Between Generativity and Social Asymmetry Among Older Adults in Japan.

OBJECTIVES: Loneliness and social isolation are major public health concerns among older adults in Japan. Generativity, the concern for and commitment to future generations, may buffer older adults from loneliness. This study examined the cross-sectional and longitudinal associations between generativity and social asymmetry (the discrepancy between social isolation and loneliness) among older adults in Japan. METHODS: Data were from 2 waves (2008 and 2012) of the Midlife in Japan survey, a nationally representative longitudinal study of 645 adults aged 30-79 residing in the Tokyo metropolitan area. Generativity was measured using the 6-item Loyola Generativity Scale. Social asymmetry was computed as the residual score from regressing loneliness onto social isolation. RESULTS: Higher generativity levels were associated with lower social asymmetry scores (B=-0.21, SE=0.04), but generativity change across waves did not predict social asymmetry 4 years later (B=-0.04, SE=0.06). DISCUSSION: Generativity may play a protective role in buffering older adults from the adverse effects of social isolation on loneliness. Promoting generativity among older adults may be a potential intervention strategy to reduce loneliness and improve well-being in aging populations in Japan.

An observational, patient-reported outcome study of sleep quality and depression among individuals with overactive bladder syndrome.

INTRODUCTION: Overactive bladder (OAB) can adversely affect health-related quality-of-life (HRQoL) and adherence to treatments; however, the extent of their association is unknown. This study sought to characterize Sleep Disturbance, Depression, Fatigue, and patient-reported medication adherence among adults with OAB in the United States. MATERIALS AND METHODS: In this descriptive, observational study, patients completed patient-reported outcome (PRO) measures of urinary symptoms, anxiety, depression, fatigue, sleep quality, and medication adherence. PRO scores were compared across age, sex, body mass index, and sleep and antidepressant medication-taking subgroups. Exploratory analyses compared PRO scores between groups and estimated the effect size of differences. RESULTS: Of 1013 patients contacted, 159 completed the assessments (female: 67.3%; ≥65 years of age: 53.5%; most severe OAB symptom: nocturia). Scale scores for Sleep Disturbance, Fatigue, and Depression were consistent with US population norms. No correlations of moderate or greater magnitude were observed between the severity of lower urinary tract symptoms and Sleep Disturbance, Fatigue, or Depression. When comparing individuals receiving antidepressants with those who were not, almost all outcomes including urinary symptoms, anxiety, and depression were significantly worse. Patients taking antidepressants also had poorer adherence to their OAB medications. CONCLUSION: In this cohort of individuals with OAB, Sleep Disturbance, Fatigue, and Depression scores were in line with general population reference values; however, among the subgroups analyzed, patients on antidepressants had worse HRQoL and more substantial impacts on medication adherence, highlighting the importance of the assessment and management of depression in this population.

Coinhibition of topoisomerase 1 and BRD4-mediated pause release selectively kills pancreatic cancer via readthrough transcription.

Pancreatic carcinoma lacks effective therapeutic strategies resulting in poor prognosis. Transcriptional dysregulation due to alterations in KRAS and MYC affects initiation, development, and survival of this tumor type. Using patient-derived xenografts of KRAS- and MYC-driven pancreatic carcinoma, we show that coinhibition of topoisomerase 1 (TOP1) and bromodomain-containing protein 4 (BRD4) synergistically induces tumor regression by targeting promoter pause release. Comparing the nascent transcriptome with the recruitment of elongation and termination factors, we found that coinhibition of TOP1 and BRD4 disrupts recruitment of transcription termination factors. Thus, RNA polymerases transcribe downstream of genes for hundreds of kilobases leading to readthrough transcription. This occurs during replication, perturbing replisome progression and inducing DNA damage. The synergistic effect of TOP1 + BRD4 inhibition is specific to cancer cells leaving normal cells unaffected, highlighting the tumor's vulnerability to transcriptional defects. This preclinical study provides a mechanistic understanding of the benefit of combining TOP1 and BRD4 inhibitors to treat pancreatic carcinomas addicted to oncogenic drivers of transcription and replication.

Identification and assessment of classification criteria attributes for systemic lupus erythematosus in a regional medical record data network.

OBJECTIVE: To assess the application and utility of algorithms designed to detect features of SLE in electronic health record (EHR) data in a multisite, urban data network. METHODS: Using the Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN), a Clinical Data Research Network (CDRN) containing data from multiple healthcare sites, we identified patients with at least one positively identified criterion from three SLE classification criteria sets developed by the American College of Rheumatology (ACR) in 1997, the Systemic Lupus International Collaborating Clinics (SLICC) in 2012, and the European Alliance of Associations for Rheumatology and the ACR in 2019 using EHR-based algorithms. To measure the algorithms' performance in this data setting, we first evaluated whether the number of clinical encounters for SLE was associated with a greater quantity of positively identified criteria domains using Poisson regression. We next quantified the amount of SLE criteria identified at a single healthcare institution versus all sites to assess the amount of SLE-related information gained from implementing the algorithms in a CDRN. RESULTS: Patients with three or more SLE encounters were estimated to have documented 2.77 (2.73 to 2.80) times the number of positive SLE attributes from the 2012 SLICC criteria set than patients without an SLE encounter via Poisson regression. Patients with three or more SLE-related encounters and with documented care from multiple institutions were identified with more SLICC criteria domains when data were included from all CAPriCORN sites compared with a single site (p<0.05). CONCLUSIONS: The positive association observed between amount of SLE-related clinical encounters and the number of criteria domains detected suggests that the algorithms used in this study can be used to help describe SLE features in this data environment. This work also demonstrates the benefit of aggregating data across healthcare institutions for patients with fragmented care.

Development and psychometric validation of the Pandemic-Related Traumatic Stress Scale for children and adults.

To assess the public health impact of the COVID-19 pandemic on mental health, investigators from the National Institutes of Health Environmental influences on Child Health Outcomes (ECHO) research program developed the Pandemic-Related Traumatic Stress Scale (PTSS). Based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) acute stress disorder symptom criteria, the PTSS is designed for adolescent (13-21 years) and adult self-report and caregiver-report on 3-12-year-olds. To evaluate psychometric properties, we used PTSS data collected between April 2020 and August 2021 from non-pregnant adult caregivers (n = 11,483), pregnant/postpartum individuals (n = 1,656), adolescents (n = 1,795), and caregivers reporting on 3-12-year-olds (n = 2,896). We used Mokken scale analysis to examine unidimensionality and reliability, Pearson correlations to evaluate relationships with other relevant variables, and analyses of variance to identify regional, age, and sex differences. Mokken analysis resulted in a moderately strong, unidimensional scale that retained nine of the original 10 items. We detected small to moderate positive associations with depression, anxiety, and general stress, and negative associations with life satisfaction. Adult caregivers had the highest PTSS scores, followed by adolescents, pregnant/postpartum individuals, and children. Caregivers of younger children, females, and older youth had higher PTSS scores compared to caregivers of older children, males, and younger youth, respectively. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

The need for greater skin of color training: perspectives from communities of color.

More than half of the population will belong to a minority group by the year 2044. Further research needs to be done into the perceptions of those with skin of color regarding their dermatologic care. This study assessed the perceptions and preferences of communities of color regarding the care of their skin and hair. An anonymous, cross-sectional, multiple-choice, online survey was administered from August through October 2021. Participants were recruited using ResearchMatch, a national volunteer health registry supported by the US National Institutes of Health. Eligibility criteria included being 18 years or older, identifying with at least one racial/ethnic group within skin of color, and living in the United States. A total of 547 participants completed the survey, 463 women (84.6%) and 84 men (15.4%) with a mean (standard deviation) age of 44.1 (15.4) years. 301 self-identified as Black (55.0%), 84 Latinx (15.4%), 90 Asian (16.5%), and 72 Multiracial (13.2%). Participants did not feel like dermatologists are trained to treat skin of color (69.5%, n = 380) or ethnic hair (75.1%, n = 411). Participants believed that all dermatologists should have training in skin of color (92.3%, n = 505) and would be more likely to see a dermatologist if they had skin of color training (80.1%, n = 438) as they felt dermatologists who have skin of color training are better equipped to treat their conditions (67.1%, n = 367). Participants were more comfortable receiving treatment at clinics that specialize in skin of color (75.1%, n = 411), but overwhelmingly had never heard of skin of color clinics (94.1%, n = 515). Participants were willing to contribute non-identifiable photos (96.3%, n = 527) and stories about skin and hair diseases (94.1%, n = 515) to create skin of color resources to train dermatologists. Overall, perceptions of communities of color on dermatologic care need to be improved. Greater skin of color training including all races/ethnicities and skin tones is imperative, and greater visibility and resources should also be put into skin of color clinics and formal skin of color research.

The Impact of Non-English Language Preference on Pediatric Hospital Outcomes.

OBJECTIVES: To characterize the relationship between non-English language preference (NELP) and hospital outcomes including length of stay (LOS), time of discharge, emergency department return visits, readmissions, and cost for pediatric general medicine inpatients. METHODS: We conducted a retrospective analysis at an urban, quaternary care, free-standing children's hospital. Patients ages 0 to 18 admitted to any general medicine service between January 1, 2017, and December 31, 2019 were included. Patients were divided into 3 language preference categories: English, Spanish, and non-Spanish NELP. Single and multifactor regression analysis was used to model differences in outcome measures by language preference adjusted for technology dependence. RESULTS: A total of 4820 patients met criteria. In adjusted models, the average LOS for English-speaking patients was 126 hours; LOS for patients who preferred Spanish was not significantly different, whereas LOS for patients with non-Spanish NELP was 50% longer (P < .001). English-speaking patients were discharged earliest in the day (mean 3:08 pm), with patients who preferred Spanish discharged 0.5 hours later and patients with non-Spanish NELP discharged 1.1 hours later than English-speaking patients (P < .001). Patients with NELP were found to be technology-dependent more frequently (P < .001) than the English preference group. Emergency department return visits, readmissions, and cost were not significantly different between groups. CONCLUSIONS: NELP was associated with longer length of stay and discharges later in the day. The most pronounced differences occurred in patients with non-Spanish NELP who also had more frequent technology dependence and more limited access to interpreters.

Intergenerational transmission of the effects of maternal exposure to childhood maltreatment in the USA: a retrospective cohort study.

BACKGROUND: Childhood maltreatment is associated with adverse health outcomes and this risk can be transmitted to the next generation. We aimed to investigate the association between exposure to maternal childhood maltreatment and common childhood physical and mental health problems, neurodevelopmental disorders, and related comorbidity patterns in offspring. METHODS: We conducted a retrospective cohort study using data from the Environmental influences on Child Health Outcomes (ECHO) Program, which was launched to investigate the influence of early life exposures on child health and development in 69 cohorts across the USA. Eligible mother-child dyads were those with available data on maternal childhood maltreatment exposure and at least one child health outcome measure (autism spectrum disorder, attention-deficit hyperactivity disorder [ADHD], internalising problems, obesity, allergy, and asthma diagnoses). Maternal history of childhood maltreatment was obtained retrospectively from the Adverse Childhood Experiences or Life Stressor Checklist questionnaires. We derived the prevalence of the specified child health outcome measures in offspring across childhood and adolescence by harmonising caregiver reports and other relevant sources (such as medical records) across cohorts. Child internalising symptoms were assessed using the Child Behavior Checklist. Associations between maternal childhood maltreatment and childhood health outcomes were measured using a series of mixed-effects logistic regression models. Covariates included child sex (male or female), race, and ethnicity; maternal and paternal age; maternal education; combined annual household income; maternal diagnosis of depression, asthma, ADHD, allergy, or autism spectrum disorder; and maternal obesity. Two latent class analyses were conducted: to characterise patterns of comorbidity of child health outcomes; and to characterise patterns of co-occurrence of childhood maltreatment subtypes. We then investigated the association between latent class membership and maternal childhood maltreatment and child health outcomes, respectively. FINDINGS: Our sample included 4337 mother-child dyads from 21 longitudinal cohorts (with data collection initiated between 1999 and 2016). Of 3954 mothers in the study, 1742 (44%) had experienced exposure to abuse or neglect during their childhood. After adjustment for confounding, mothers who experienced childhood maltreatment were more likely to have children with internalising problems in the clinical range (odds ratio [OR] 2·70 [95% CI 1·95-3·72], p<0·0001), autism spectrum disorder (1·70 [1·13-2·55], p=0·01), ADHD (2·09 [1·63-2·67], p<0·0001), and asthma (1·54 [1·34-1·77], p<0·0001). In female offspring, maternal childhood maltreatment was associated with a higher prevalence of obesity (1·69 [1·17-2·44], p=0·005). Children of mothers exposed to childhood maltreatment were more likely to exhibit a diagnostic pattern characterised by higher risk for multimorbidity. Exposure to multiple forms of maltreatment across all subtypes of maternal childhood maltreatment was associated with the highest risk increases for most offspring health outcomes, suggesting a dose-response relationship. INTERPRETATION: Our findings suggest that maternal childhood maltreatment experiences can be a risk factor for disease susceptibility in offspring across a variety of outcomes and emphasise the need for policies focusing on breaking the intergenerational transmission of adversity. FUNDING: Environmental influences on Child Health Outcomes Program, Office of the Director, National Institutes of Health.

Associations Between Loneliness and Cognitive Resilience to Neuropathology in Older Adults.

OBJECTIVES: Loneliness in the aging population is associated with decreased cognitive function and increased neuropathology; less is understood about the association of loneliness and cognitive resilience (CR), defined as the discordance between a person's actual and expected cognition given their neuropathology. Here we assess the effect of loneliness and change in loneliness on CR at end of life and across older adulthood. METHODS: Data were combined from 2 longitudinal studies of older adults. CR proximate to death (CRlast_level) and across time (CRslope) was obtained by independently regressing global cognition and change in cognition onto multiple neuropathology indicators and extracting the resulting residuals. We used a series of simple linear regression models to assess the effect of loneliness level and change on CRlast_level and CRslope. RESULTS: Higher baseline loneliness was associated with lower CRlast_level (ß = -0.11, 95% confidence interval [95% CI; -0.18, -0.04], p < .01); higher baseline loneliness and increasing loneliness over time was associated with lower CRslope (ß = -0.13, 95% CI [-0.22, -0.05], p < .01 and ß = -0.12, 95% CI [-0.20, -0.04], p < .01, respectively). Results were robust to covariate inclusion and independent of objective social isolation. DISCUSSION: Higher and increasing loneliness was associated with lower CR in the face of neuropathology. These results suggest that some individuals are less resilient to the accumulation of neuropathology than others, and experiencing high/increasing loneliness is a key factor putting some at risk. Interventions aimed at optimizing cognitive function across older adults should include loneliness reduction as a potential area of focus.

Secukinumab responses vary across the spectrum of congenital ichthyosis in adults.

IMPORTANCE: Treatment of congenital ichthyoses primarily focuses on reversing skin scaling and is not pathogenesis based. Recent studies showed Th17 immune skewing, as in psoriasis, across the spectrum of ichthyosis, suggesting that targeting this pathway might broadly reduce disease severity. OBJECTIVE: To determine whether secukinumab, an IL-17A inhibitor, can improve ichthyosis across several congenital ichthyosis subtypes. DESIGN: Exploratory 16-week double-blind, randomized, placebo-controlled trial comparing secukinumab 300 mg every 4wks to placebo (1:1 randomization) in adults with the four major congenital ichthyosis subtypes (NCT03041038), followed by a 16-week open-label phase to evaluate response of the placebo-first group and a 20-week extension for safety. Significant differences in secukinumab- vs. placebo-treated subjects at Wk16 in the Ichthyosis Area Severity Index (IASI) score and lack of increased mucocutaneous bacterial and/or fungal infections were the co-primary efficacy and safety endpoints, respectively. SETTING: Two tertiary referral centers: Northwestern University Feinberg School of Medicine, Chicago, and Mount Sinai Icahn School of Medicine, New York. PARTICIPANTS: Twenty subjects ≥ 18 yo with genotype-confirmed epidermolytic ichthyosis, Netherton syndrome, lamellar ichthyosis, or congenital ichthyosiform erythroderma with at least moderate erythroderma. RESULTS: IL-17A inhibition did not significantly reduce severity or increase mucocutaneous infections among the 18 who completed the 16-week double-blind phase. Five patients with 29-50% clinical improvement at Wk32 requested drug continuation. Th17-related biomarkers were not significantly reduced vs. baseline or placebo-treated levels. LIMITATIONS: Small sample size; heterogeneous ichthyosis subsets. CONCLUSION: IL-17 inhibition with secukinumab is safe, but not efficacious across the spectrum of adult ichthyoses. GOV REGISTRATION NUMBER: NCT03041038; first posted on 02/02/2017.

Timing of scratch and limb movements during sleep in children with atopic dermatitis.

In this retrospective analysis of children with atopic dermatitis (n = 6) who coincidentally had a video polysomnography, we found that most nocturnal limb movements in children with atopic dermatitis are non-scratch versus scratch, 109.0 ± 67.9 vs. 15.3 ± 5.4 (p = 0.01). Average scratch duration was 8.4 ± 2.7 s, which was not different by sleep stage. Scratch movements are distinct in timing, occurring most often during N2 sleep, in the first third of sleep, and peaking at 90 minutes after sleep onset, corresponding with completion of the first sleep cycle.

Mindfulness-based stress reduction for men on active surveillance for prostate cancer and their spouses: Design and methodology of a randomized controlled trial.

BACKGROUND: Although active surveillance (AS) is an increasingly adopted treatment paradigm for management of very low risk prostate cancer, many men and their partners face a variety of AS-related psychosocial stressors. Stressors may include anxiety and fear of progression, which may negatively affect short- and long-term psychosocial adjustment and influence early withdrawal from AS in order to seek definitive therapies such as surgery or radiation. Here we describe the protocol for an NCI-funded trial, which seeks to examine the efficacy of mindfulness training compared with a time/attention-matched health promotion control condition in a geographically generalizable sample of men on AS and their spouses. METHODS: Using a randomized, controlled, partially double-blinded study design, this study involves the delivery of 8 weeks of standardized mindfulness training (MBSR; mindfulness-based stress reduction) and patient reported outcomes over a 12-month period (proposed enrollment of 80 men on AS and spouses), compared with a health promotion control (proposed enrollment of 80 men on AS and spouses) that has been matched for time and attention. Baseline (T1) measures (e.g., anxiety, fear of progression, quality of life) are administered just prior to randomization to the two study arms, followed by repeated assessments at 2 months (T2), 6 months (T3) and 12 months (T4). CONCLUSION: This study has the potential to offer men and their partners on AS with important educational and self-regulatory skills to better cope and adjust with known stressors related to being placed on this protocol.

Exploring Retention, Usage, and Efficacy of Web-Based Delivery of Positive Emotion Regulation Skills During the COVID-19 Pandemic.

COVID-19 prompted distress and increased reliance on digital mental health interventions, which previously demonstrated low rates of retention and adherence. This single-arm trial evaluated whether self-guided, web-based, positive affect regulation skills (PARK) were engaging and associated with changes in well-being during the pandemic. Over 6 weeks, PARK delivers brief lessons and practices in skills designed to increase positive emotions: noticing positive events, savoring, gratitude, mindfulness, positive reappraisal, personal strengths, and self-compassion. Patient-Reported Outcome Measurement Information System (PROMIS) computer adaptive tests of anxiety, depression, social isolation, positive affect, and meaning and purpose were administered at baseline, post-intervention, and 6 months after baseline. Retention and usage of PARK were measured by the web-based assessment and intervention platforms. The sample (n = 616) was predominantly female, non-Hispanic, white, and well-educated. Of those who completed baseline, only 42% completed a follow-up assessment; 30% never logged into PARK. Among those who did, 86% used at least one skill, but only 14% completed PARK. Across retention and usage metrics, older age predicted more engagement. In multivariable models, people of color and people with greater baseline anxiety were more likely to complete PARK. All well-being indicators improved over time, with greater improvements in anxiety and social isolation among participants who accessed at least one PARK skill compared to those who did not. Retention and usage rates mirrored pre-pandemic trends, but within this select sample, predictors of engagement differed from prior research. Findings underscore the need for additional efforts to ensure equitable access to digital mental health interventions and research. Trials registration: NCT04367922.