A Pilot Feasibility Evaluation of a Heart Rate Variability Biofeedback App to Improve Self-Care in COVID-19 Healthcare Workers.

COVID-19 exacerbated burnout and mental health concerns among the healthcare workforce. Due to high work stress, demanding schedules made attuned eating behaviors a particularly challenging aspect of self-care for healthcare workers. This study aimed to examine the feasibility and acceptability of a heart rate variability biofeedback (HRVB) mobile app for improving well-being among healthcare workers reporting elevated disordered eating during COVID-19. We conducted a mixed methods pre-mid-post single-arm pilot feasibility trial (ClinicalTrials.gov NCT04921228). Deductive content analysis of participants' commentary generated qualitative themes. Linear mixed models were used to examine changes in pre- mid- to post-assessment scores on well-being outcomes. We consented 28 healthcare workers (25/89% female; 23/82% Non-Hispanic White; 22/79% nurses) to use and evaluate an HRVB mobile app. Of these, 25/89% fully enrolled by attending the app and device training; 23/82% were engaged in all elements of the protocol. Thirteen (52%) completed at least 10 min of HRVB on two-thirds or more study days. Most participants (18/75%) reported being likely or extremely likely to continue HRVB. Common barriers to engagement were busy schedules, fatigue, and technology difficulties. However, participants felt that HRVB helped them relax and connect better to their body's signals and experiences. Results suggested preliminary evidence of efficacy for improving interoceptive sensibility, mindful self-care, body appreciation, intuitive eating, stress, resilience, and disordered eating. HRVB has potential as a low-cost adjunct tool for enhancing well-being in healthcare workers through positively connecting to the body, especially during times of increased stress when attuned eating behavior becomes difficult to uphold.

Eating Disorder Examination-Questionnaire and Clinical Impairment Assessment norms for intersectional identities using an MTurk sample.

OBJECTIVE: There are limited data to guide the interpretation of scores on measures of eating-disorder psychopathology among underrepresented individuals. We aimed to provide norms for the Eating Disorder Examination-Questionnaire (EDE-Q) and Clinical Impairment Assessment (CIA) across racial/ethnic, gender, and sexual identities, and sexual orientations and their intersections by recruiting a diverse sample of Amazon MTurk workers (MTurkers; N = 1782). METHOD: We created a comprehensive, quantitative assessment of racial/ethnic identification, gender identification, sex assigned at birth, current sexual identification, and sexual orientation called the Demographic Assessment of Racial, Sexual, and Gender Identities (DARSGI). We calculated normative data for each demographic category response option. RESULTS: Our sample was comprised of 68% underrepresented racial/ethnic identities, 42% underrepresented gender identities, 13% underrepresented sexes, and 49% underrepresented sexual orientations. We reported means and standard deviations for each demographic category response option and, where possible, mean estimates by percentile across intersectional groups. EDE-Q Global Score for a subset of identities and intersections in the current study were higher than previously reported norms for those identities/intersections. DISCUSSION: This is the most thorough reporting of norms for the EDE-Q and CIA among racial/ethnic, sexual, and gender identities, and sexual orientations and the first reporting on multiple intersections, filling some of the gaps for commonly used measures of eating-disorder psychopathology. These norms may be used to contextualize eating-disorder psychopathology reported by underrepresented individuals. The data from the current study may help inform research on the prevention and treatment of eating-disorder psychopathology in underrepresented groups. PUBLIC SIGNIFICANCE: We provide the most thorough reporting on racial/ethnic, sexual, and gender identities, and sexual orientations for the Eating Disorder Examination - Questionnaire and Clinical Impairment Assessment, and the first reporting on intersections, which fills some of the gaps for commonly used measures of eating-disorder psychopathology. These norms help inform research on the prevention and treatment of eating-disorder psychopathology in underrepresented groups.

Self-reported symptom causes of mobility difficulty contributing to fear of falling in older adults.

BACKGROUND: Self-reported symptom causes of mobility difficulty that contribute to  fear of falling (FOF) in older adults has not been fully explored as an area for intervention. AIMS: Identify the prevalence of self-reported symptoms causing mobility difficulties and to examine the difference in FOF by symptom category. METHODS: Conduct a secondary data analysis of a population-based cohort of community-dwelling older adults, ≥ 70 years, enrolled in the MOBILIZE Boston study. The analysis included 242 older adults reported difficulty walking » mile (0.4 km) and/or climbing one flight of stairs. Participants identified the main symptom cause of the mobility difficulty from a list of 32 symptoms, grouped into five categories. FOF was measured using the Tinetti Falls Efficacy Scale. RESULTS: Pain was the primary symptom causing mobility difficulty (38%), followed by endurance (21%), weakness (13%), balance (9%), and other (3%). Although a greater proportion of participants who identified balance as the primary symptom category had significantly higher FOF compared to others, there was a greater number overall who reported pain as their main symptom who also had FOF. Therefore, pain contributed to a higher relative burden of FOF in the population than did balance symptoms. DISCUSSION: Various symptoms affect mobility and are associated with FOF, a known fall risk factor. Many older adults identify pain as the main cause of their mobility difficulty and report FOF. CONCLUSIONS: Improving pain symptoms for older adults may improve mobility and reduce fear of falling, potentially averting further decline in mobility and independence.

Psychological responses of hospital-based nurses working during the COVID-19 pandemic in the United States: A cross-sectional study.

Studies show decreased well-being during the COVID-19 pandemic, especially for healthcare providers from Asia. Less is known about the psychological responses of working during the pandemic on hospital-based registered nurses (RNs) in the United States (US). Therefore, the purpose of this paper is to report the well-being of U.S.-based hospital RNs working during the initial acute phase of COVID-19 and compare it with well-being among healthcare workers described in two global meta-analyses. We conducted a cross-sectional survey in May-June 2020 (N = 467). Well-being was measured using the following tools: Generalized Anxiety Disorder-7, Patient Health Questionnaire-2 for depressive symptoms, Impact of Events Scale-Revised for traumatic stress, and the Insomnia Severity Index. Compared with global rates from two meta-analyses, US-based RNs reported significantly more traumatic stress (54.6% vs. 11.4% and 21.5%; p < .001) and depressive symptoms (54.6% vs. 31.8% and 21.7%; p < .001). Rates of insomnia were also higher in U.S.-based RNs than in the meta-analysis that reported insomnia (32.4% vs 27.8%; p < .033). Rates of anxiety symptoms among US-based RNs did not differ from that reported in one meta-analysis (37.3% vs. 34.4%), while it was significantly higher in the other (37.3% vs. 22.1%; p < .001). Hospital-based RNs from the US exhibited over twice the rates of trauma and nearly double the rates of depressive symptoms than shown in reports from hospital workers globally during the acute phase of the COVID-19 pandemic. The lasting effects of this distress are unknown and warrant ongoing evaluation and solutions to better support emotional well-being and prevent burnout in the workplace.

The Relationship of Fear of Falling and Quality of Life: The Mediating Effects of Frailty and Depression.

PURPOSE: To examine the sequential explanatory roles of frailty and depression in the relationship between fear of falling (FOF) and health-related quality of life (HRQoL) in older adults. DESIGN: Secondary data analysis. METHODS: Path models were constructed hypothesizing frailty and depression as serial mediators of the relationship between FoF and HRQoL. FINDINGS: Depression independently and along with frailty serially mediated the relationship between FoF and mental HRQoL. CONCLUSIONS: Frailty and depression are not typically considered when assessing the effect of FOF on HRQoL. CLINICAL EVIDENCE: Understanding the mediating effects and common risk factors on FOF and HRQoL may be an area for interventional development for older adults.

Traumatic stress, body shame, and internalized weight stigma as mediators of change in disordered eating: a single-arm pilot study of the Body Trust® framework.

To enhance access to evidence-based treatment it is increasingly important to evaluate scalable virtual programs that support the needs of those struggling with disordered eating. This study described a scientifically grounded, trauma-informed framework known as Body Trust,® and aimed to pilot test the preliminary effectiveness and mechanisms of change in a Body Trust® program to improve disordered eating. Using quality outcomes data, we examined 70 mostly white (87%) female-identifying (97%) individuals enrolled in a 6-module online program based in the Body Trust® framework (Mage = 45.5 ±10.9; MBMI = 33.7 ±8.0). Putative mediators included traumatic stress, internalized weight stigma, and body shame. Outcomes were objective and subjective binge episodes, overvaluation of weight and shape, and eating concerns. Generalized estimating equations were applied to determine pre-to-post changes. We applied Montoya's MEMORE macro, the joint-significance test, and calculated 95% Monte Carlo confidence intervals to assess mediation. Significant pre-to-post improvements with medium to large effect sizes were detected for all outcomes and mediators (ps<.008). All hypothesized mechanisms supported mediation. Using the Body Trust® framework shows early promise for alleviating disordered eating symptoms through targeting traumatic stress, body shame, and internalized weight stigma. Given the program's use of mindfulness techniques, future research should test target mechanisms like interoception.

Treatment Outcomes and Trajectories of Change in Patients Attributing Their Eating Disorder Onset to Anti-obesity Messaging.

OBJECTIVE: Given the increased prevalence of eating disorders (EDs) among individuals higher on the weight spectrum, we aimed to 1) report the prevalence of ED patients in higher levels of care (residential, partial hospitalization, and intensive outpatient) attributing the onset of their ED to anti-obesity messaging, 2) report the most commonly recollected sources of those messages, and 3) determine if those attributing the onset of their ED to anti-obesity messaging a) enter, b) exit, and c) respond to treatment differently from peers who did not. METHODS: This retrospective cohort study used data from 2901 patients receiving ED treatment in higher levels of care at a US-based center between 2015 and 2018. Multilevel models examined differences in ED symptoms and trajectories of change over time. NVivo was used to analyze the patients' comments about sources of messages. RESULTS: Eighteen percent attributed their ED onset to anti-obesity messaging, 45% did not, and 37% were unsure. Of those providing comments, the most common sources included the following: educational curriculum/school context (45.9%), media/Internet (24.7%), health care (10.4%), family (9%), and peer bullying (3.7%). At admission, patients attributing their ED onset to anti-obesity messaging had more severe ED symptoms than those who did not (γ = 0.463, standard error [SE] = 0.086, p < .001) and those who were unsure (γ = 0.288, SE = 0.089, p < .001); no differences were evident at discharge (p > .483). During phase 2 of treatment, patients attributing their ED onset to anti-obesity messaging improved faster than those who did not (γ = 0.003, SE = 0.001, p = .008) and those who were unsure (γ = 0.003, SE = 0.001, p = .014). CONCLUSIONS: Anti-obesity messaging may put vulnerable individuals at risk for EDs. We recommend increasing weight bias training for school personnel and health care professionals. To reduce health disparities, we also suggest the promotion of weight-neutral health-enhancing self-care practices in media and public health campaigns, legislative policies, and health care overall.

Restrictive eating disorders in higher weight persons: A systematic review of atypical anorexia nervosa prevalence and consecutive admission literature.

OBJECTIVE: Currently, there is debate in the eating disorders field regarding how to define atypical anorexia (AAN), how prevalent it is in community and clinical settings, and how AAN rates compare with low-weight AN. This systematic review assesses AAN literature from 2007 to 2020, to investigate: (a) the demographic characteristics of AAN studies, (b) the prevalence of AAN compared with AN, (c) the range of operational definitions of AAN and the implications of these definitions, and (d) the proportion of patients with AAN and AN represented in consecutive admission and referral samples. METHOD: PsychINFO, CINAHL, PubMed, Greylit.org, and ProQuest databases were searched according to methods for Preferred Reporting Items for Systematic Reviews and Meta-Analyses systematic reviews, yielding 3,184 potential articles. Seventy-five eligible studies were coded for sixty-one variables. RESULTS: Clinical samples predominantly included younger, female, white samples with limited diversity. In epidemiological designs, AAN was typically as common or more common than AN, and AAN rates varied significantly based on the population studied and operational definitions. In consecutive clinical samples, AAN was frequently less represented. DISCUSSION: Although AAN appears to occur more frequently than AN in communities, fewer patients with AAN are being referred and admitted to eating disorder specific care, particularly in the United States. Given the significant medical and psychosocial consequences of AAN, and the importance of early intervention, this represents a crucial treatment gap. Additionally, results suggest the need for fine-tuning diagnostic definitions, greater diversity in AAN studies, and increased screening and referral for this vulnerable population.

OBJETIVO: Actualmente, hay debate en el campo de los trastornos alimenticios sobre cómo definir la anorexia atípica (ANA), cuán prevalente es en entornos comunitarios y clínicos, y cómo las tasas de ANA se comparan con AN de bajo peso. Esta revisión sistemática evalúa la literatura de ANA de 2007 a 2020, para investigar: 1) las características demográficas de los estudios de ANA, 2) la prevalencia de ANA en comparación con AN, 3) el rango de definiciones operativas de ANA y las implicaciones de estas definiciones, y 4) la proporción de pacientes con ANA y AN representados en muestras consecutivas de admisión y derivación. MÉTODO: Las bases de datos de PsychINFO, CINAHL, PubMed, Greylit.orgy y ProQuest fueron buscados de acuerdo con los métodos preferidos para el reporte de ítems para Revisiones Sistemáticas y Metanálisis de Revisiones Sistemáticas, dando lugar a 3184 artículos potenciales. Setenta y cinco estudios elegibles fueron codificados para 61 variables. RESULTADOS: Las muestras clínicas incluían predominantemente muestras de femeninas, más jóvenes, y blancas con diversidad limitada. En los diseños epidemiológicos, la ANA era típicamente tan común o más común que AN, y las tasas de ANA variaban significativamente en función de la población estudiada y las definiciones operacionales. En muestras clínicas consecutivas, la ANA fue frecuentemente menos representada. DISCUSIÓN: Aunque ANA parece ocurrir con más frecuencia que AN en las comunidades, menos pacientes con ANA están siendo referidos y admitidos a la atención específica del trastorno alimentario, particularmente en los Estados Unidos. Dadas las importantes consecuencias médicas y psicosociales de ANA, y la importancia de la intervención temprana, esto representa una brecha de tratamiento crucial. Además, los resultados sugieren la necesidad de ajustar las definiciones diagnósticas, una mayor diversidad en los estudios de ANA y un mayor cribado y referencia a tratamiento para esta población vulnerable.

Serial Neurologic Assessment in Pediatrics (SNAP): A New Tool for Bedside Neurologic Assessment of Critically Ill Children.

OBJECTIVES: We developed a tool, Serial Neurologic Assessment in Pediatrics, to screen for neurologic changes in patients, including those who are intubated, are sedated, and/or have developmental disabilities. Our aims were to: 1) determine protocol adherence when performing Serial Neurologic Assessment in Pediatrics, 2) determine the interrater reliability between nurses, and 3) assess the feasibility and acceptability of using Serial Neurologic Assessment in Pediatrics compared with the Glasgow Coma Scale. DESIGN: Mixed-methods, observational cohort. SETTING: Pediatric and neonatal ICUs. SUBJECTS: Critical care nurses and patients. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Serial Neurologic Assessment in Pediatrics assesses Mental Status, Cranial Nerves, Communication, and Motor Function, with scales for children less than 6 months, greater than or equal to 6 months to less than 2 years, and greater than or equal to 2 years old. We assessed protocol adherence with standardized observations. We assessed the interrater reliability of independent Serial Neurologic Assessment in Pediatrics assessments between pairs of trained nurses by percent- and bias- adjusted kappa and percent agreement. Semistructured interviews with nurses evaluated acceptability and feasibility after nurses used Serial Neurologic Assessment in Pediatrics concurrently with Glasgow Coma Scale during routine care. Ninety-eight percent of nurses (43/44) had 100% protocol adherence on the standardized checklist. Forty-three nurses performed 387 paired Serial Neurologic Assessment in Pediatrics assessments (149 < 6 mo; 91 ≥ 6 mo to < 2 yr, and 147 ≥ 2 yr) on 299 patients. Interrater reliability was substantial to near-perfect across all components for each age-based Serial Neurologic Assessment in Pediatrics scale. Percent agreement was independent of developmental disabilities for all Serial Neurologic Assessment in Pediatrics components except Mental Status and lower extremity Motor Function for patients deemed "Able to Participate" with the assessment. Nurses reported that they felt Serial Neurologic Assessment in Pediatrics, compared with Glasgow Coma Scale, was easier to use and clearer in describing the neurologic status of patients who were intubated, were sedated, and/or had developmental disabilities. About 92% of nurses preferred to use Serial Neurologic Assessment in Pediatrics over Glasgow Coma Scale. CONCLUSIONS: When used by critical care nurses, Serial Neurologic Assessment in Pediatrics has excellent protocol adherence, substantial to near-perfect interrater reliability, and is feasible to implement. Further work will determine the sensitivity and specificity for detecting clinically meaningful neurologic decline.

Systemic Endothelial Activation Is Associated With Early Acute Respiratory Distress Syndrome in Children With Extrapulmonary Sepsis.

OBJECTIVES: Systemic endothelial activation may contribute to sepsis-associated organ injury, including acute respiratory distress syndrome. We hypothesized that children with extrapulmonary sepsis with versus without acute respiratory distress syndrome would have plasma biomarkers indicative of increased endothelial activation and that persistent biomarker changes would be associated with poor outcome. DESIGN: Observational cohort. SETTING: Academic PICU. PATIENTS: Patients less than 18 years old with sepsis from extrapulmonary infection with (n = 46) or without (n = 54) acute respiratory distress syndrome and noninfected controls (n = 19). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Endothelial (angiopoietin-1, angiopoietin-2, tyrosine kinase with immunoglobulin-like loop epidermal growth factor homology domain 2, vascular endothelial growth factor, soluble fms-like tyrosine kinase, von Willebrand factor, E-selectin, intercellular adhesion molecule, vascular cell adhesion molecule, thrombomodulin) and inflammatory biomarkers (C-reactive protein, interleukin-6, and interleukin-8) were measured from peripheral plasma collected within 3 days (time 1) of sepsis recognition and at 3-6 days (time 2) and 7-14 days (time 3). Time 1 biomarkers and longitudinal measurements were compared for sepsis patients with versus without acute respiratory distress syndrome and in relation to complicated course, defined as greater than or equal to two organ dysfunctions at day 7 or death by day 28. Angiopoietin-2, angiopoietin-2/angiopoietin-1 ratio, tyrosine kinase with immunoglobulin-like loop epidermal growth factor homology domain 2, vascular endothelial growth factor, von Willebrand factor, E-selectin, intercellular adhesion molecule, vascular cell adhesion molecule, thrombomodulin, endocan, C-reactive protein, interleukin-6, and interleukin-8 were different between sepsis and noninfected control patients at time 1. Among patients with sepsis, those with acute respiratory distress syndrome had higher angiopoietin-2/angiopoietin-1 ratio, vascular endothelial growth factor, vascular cell adhesion molecule, thrombomodulin, endocan, interleukin-6, and interleukin-8 than those without acute respiratory distress syndrome (all p < 0.003). Angiopoietin-2 and angiopoietin-2/angiopoietin-1 ratio remained higher in sepsis with versus without acute respiratory distress syndrome after multivariable analyses. Time 1 measures of angiopoietin-2, angiopoietin-2/-1 ratio, von Willebrand factor, and endocan were indicative of complicated course in all sepsis patients (all area under the receiver operating curve ≥ 0.80). In sepsis without acute respiratory distress syndrome, soluble fms-like tyrosine kinase decreased more quickly and von Willebrand factor and thrombomodulin decreased more slowly in those with complicated course. CONCLUSIONS: Children with extrapulmonary sepsis with acute respiratory distress syndrome had plasma biomarkers indicative of greater systemic endothelial activation than those without acute respiratory distress syndrome. Several endothelial biomarkers measured near sepsis recognition were associated with complicated course, whereas longitudinal biomarker changes yielded prognostic information only in those without sepsis-associated acute respiratory distress syndrome.

Sexual and gender minority individuals report higher rates of abuse and more severe eating disorder symptoms than cisgender heterosexual individuals at admission to eating disorder treatment.

Eating disorders (EDs) occur at higher rates among sexual/gender minorities (SGMs). We currently know little about the risk factor profile of SGMs entering ED specialty care. OBJECTIVE: To (a) compare history of abuse-related risk in SGMs to cisgender heterosexuals (CHs) when entering treatment, (b) determine if SGMs enter and exit treatment with more severe ED symptoms than CHs, and (c) determine if SGMs have different rates of improvement in ED symptoms during treatment compared to CHs. METHOD: We analyzed data from 2,818 individuals treated at a large, US-based, ED center, 471 (17%) of whom identified as SGM. Objective 1 was tested using logistic regression and Objectives 2 and 3 used mixed-effects models. RESULTS: SGMs had higher prevalence of sexual abuse (OR = 2.10, 95% CI = 1.71, 2.58), other trauma (e.g., verbal/physical/emotional abuse; OR = 2.07, 95% CI = 1.68, 2.54), and bullying (OR = 2.13, 95% CI = 1.73, 2.62) histories. SGMs had higher global EDE-Q scores than CHs at admission (γ = 0.42, SE = 0.08, p < .001) but improved faster early in treatment (γ = 0.316, SE = 0.12, p = .008). By discharge, EDE-Q scores did not differ between SGMs and CHs. DISCUSSION: Our main hypothesis of greater abuse histories among SGMs was supported and could be one explanation of their more severe ED symptoms at treatment admission compared to CHs. In addition, elevated symptom severity in SGMs at admission coincides with greater delay between ED onset and treatment initiation among SGMs-possibly a consequence of difficulties with ED recognition in SGMs by healthcare providers. We recommend increased training for providers on identifying EDs in SGMs to reduce barriers to early intervention.

Principal Factors Associated With Ketorolac-Refractory Pain Behavior After Pediatric Myringotomy and Pressure Equalization Tube Placement: A Retrospective Cohort Study.

BACKGROUND: Prophylactic analgesic administration reduces pain behavior after pediatric bilateral myringotomy and pressure equalization tube placement (BMT). We hypothesized that postoperative pain in children treated with intraoperative ketorolac would, among several exposures of interest, be strongly associated with ear condition. METHODS: We conducted a retrospective cohort study of healthy children (9 months to 7 years) who underwent BMT at the Children's Hospital of Philadelphia or its ambulatory surgery centers from 2013 to 2016. Anesthetic care included preoperative oral midazolam, sevoflurane/nitrous oxide (N2O)/air/oxygen (O2) by mask, and intramuscular ketorolac. Demographic and procedural information included left and right tympanic membrane (normal, retracted, or bulging) and middle ear (normal/no, serous, mucoid, or purulent effusion) conditions. Because tympanic membrane and middle ear conditions were highly concordant and mean maximum Face, Legs, Activity, Cry and Consolability (FLACC) scores (0-10) were not different across the array of abnormal findings, we categorized each ear as normal or abnormal based on middle ear effusion alone. We then defined the ear condition of each child (primary exposure) using bilateral findings: normal/normal, normal/abnormal, and abnormal/abnormal. Secondary exposures included age, BMT history, procedure duration, facility location, and attending surgeon/anesthesiologist pair. The primary outcome was maximum postanesthesia care unit FLACC score: 4-10 (moderate-to-severe pain) versus 0-3 (no-to-low pain). Rescue oxycodone, acetaminophen administration, and emergence agitation were secondary outcomes. Statistical analysis incorporated generalized linear mixed models with random intercepts accounting for the clustering effect of provider pairs. Adjusting for multiple comparisons, significance level was set at P = .004. RESULTS: Excluding recurrent cases, 1922 unique evaluable subjects remained. The probability of moderate-to-severe pain behavior (FLACC, 4-10) was 52.4% (95% confidence interval [CI], 50.2-54.6) overall. In a confounder-adjusted model, ear condition was significantly associated with moderate-to-severe pain: compared to bilateral abnormal (effusions), odds ratio (OR) (95% CI) for bilateral normal was 2.2 (1.6-2.9), P < .0001. Younger age (OR, 1.1 [1.1-1.2] per year; P = .001) and longer procedure duration (OR, 1.1 [1.0-1.2] per minute; P = .0008) were likewise related to higher pain. With surgeon added to the model, variance explained by provider pairs decreased from 9.60% to 1.05%. Two secondary outcome associations also emerged: comparing bilateral normal to abnormal ears, ORs were 1.7 (1.3-2.2), P = .0001, for rescue oxycodone and 2.0 (1.2-3.3), P = .008, for emergence agitation. CONCLUSIONS: Pain behavior after BMT varies by surgeon and is strongly associated with ear condition. Ketorolac as a single prophylactic analgesic appears less effective in younger children with normal middle ear findings.

Prevalence of Isoelectric Electroencephalography Events in Infants and Young Children Undergoing General Anesthesia.

BACKGROUND: In infants and young children, anesthetic dosing is based on population pharmacokinetics and patient hemodynamics not on patient-specific brain activity. Electroencephalography (EEG) provides insight into brain activity during anesthesia. The primary goal of this prospective observational pilot study was to assess the prevalence of isoelectric EEG events-a sign of deep anesthesia-in infants and young children undergoing general anesthesia using sevoflurane or propofol infusion for maintenance. METHODS: Children 0-37 months of age requiring general anesthesia for surgery excluding cardiac, intracranial, and emergency cases were enrolled by age: 0-3, 4-6, 7-12, 13-18, and 19-37 months. Anesthesia was maintained with sevoflurane or propofol infusion. EEG was recorded from induction to extubation. Isoelectric EEG events (amplitude <20 µV, lasting ≥2 seconds) were characterized by occurrence, number, duration, and percent of isoelectric EEG time over anesthetic time. Associations with patient demographics, anesthetic, and surgical factors were determined. RESULTS: Isoelectric events were observed in 63% (32/51) (95% confidence interval [CI], 49-76) of patients. The median (interquartile range [IQR]) number of isoelectric events per patient was 3 (0-31), cumulative isoelectric time per patient was 12 seconds (0-142 seconds), isoelectric time per event was 3 seconds (0-4 seconds), and percent of total isoelectric over anesthetic time was 0.1% (0%-2.2%). The greatest proportion of isoelectric events occurred between induction and incision. Isoelectric events were associated with higher American Society of Anesthesiologists (ASA) physical status, propofol bolus, endotracheal tube use, and lower arterial pressure during surgical phase. CONCLUSIONS: Isoelectric EEG events were common in infants and young children undergoing sevoflurane or propofol anesthesia. Although the clinical significance of these events remains uncertain, they suggest that dosing based on population pharmacokinetics and patient hemodynamics is often associated with unnecessary deep anesthesia during surgical procedures.

A Retrospective Analysis of Neuromuscular Blocking Drug Use and Ventilation Technique on Complications in the Pediatric Difficult Intubation Registry Using Propensity Score Matching.

BACKGROUND: Ventilation is critical in airway management, and failure can be fatal. The optimal ventilation approach for endotracheal intubation in children with difficult airways remains controversial. The Pediatric Difficult Intubation (PeDI) Registry is an international multicenter registry that collects intubation data in difficult to intubate children. The registry captures the initial (at induction) and final ventilation technique (at intubation), the use of neuromuscular blocking drugs (NMBDs), airway reactivity during intubation, and complications. We analyzed data in the PeDI Registry to determine the frequency of use of various ventilation techniques and associated complications. Because spontaneously breathing patients ventilate throughout intubation, we hypothesized that spontaneous ventilation would be associated with fewer complications than other approaches. METHODS: We queried the PeDI Registry for cases entered between September 2012 and February 2016, from 16 children's hospitals. We categorized the attending anesthesiologist's ventilation plan into 3 groups: spontaneous ventilation, controlled ventilation after administering an NMBD, and controlled ventilation without administering an NMBD. Generalized Estimating Equation (GEE) model, with a binomial family distribution and logit link, was used to determine the association between ventilation technique and the risk of complications, as well as to account for within-site clustering. Propensity score matching was further applied to balance pretreatment characteristics of ventilation groups. RESULTS: Of 1289 anticipated difficult intubations, 507 (39%) were managed with spontaneous ventilation, 453 (35%) controlled ventilation with an NMBD, and 329 (26%) controlled ventilation without an NMBD. Complications occurred in 242 (18.8%; 95% confidence interval [CI], 16.6%-20.9%) patients. Of these, 218 (16.9%) were nonsevere, and 24 (1.9%) were severe. The spontaneous ventilation group had 114 (22.5%, standardized residual [Std.Res] = 4.29) nonsevere complications, which was higher than the controlled ventilation with an NMBD 60 (13.3%, Std.Res = -2.58), and controlled ventilation without an NMBD 44 (13.4%, Std.Res = -1.98), P < .001. Nearest neighbor matching with caliper width equal to 0.2 of the standard deviation (SD) of the logit of the propensity score also demonstrated that patients with spontaneous ventilation had greater odds of complications compared to controlled ventilation techniques: odds ratio (OR) = 2.07 (95% CI, 1.36-3.15; P = .001). CONCLUSIONS: Spontaneous ventilation is associated with more nonsevere complications, such as hypoxemia and laryngospasm, than controlled ventilation techniques during intubation of children with difficult airways. Inadequate anesthetic depth may contribute to increased complications.

Clinical Signs to Categorize Shock and Target Vasoactive Medications in Warm Versus Cold Pediatric Septic Shock.

OBJECTIVES: Determine level of agreement among clinical signs of shock type, identify which signs clinicians prioritize to determine shock type and select vasoactive medications, and test the association of shock type-vasoactive mismatch with prolonged organ dysfunction or death (complicated course). DESIGN: Retrospective observational study. SETTING: Single large academic PICU. PATIENTS: Patients less than 18 years treated on a critical care sepsis pathway between 2012 and 2016. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Agreement among clinical signs (extremity temperature, capillary refill, pulse strength, pulse pressure, and diastolic blood pressure) was measured using Fleiss and Cohen's κ. Association of clinical signs with shock type and shock type-vasoactive mismatch (e.g., cold shock treated with vasopressor rather than inotrope) with complicated course was determined using multivariable logistic regression. Of 469 patients, clinicians determined 307 (65%) had warm and 162 (35%) had cold shock. Agreement across all clinical signs was low (κ, 0.25; 95% CI, 0.20-0.30), although agreement between extremity temperature, capillary refill, and pulse strength was better than with pulse pressure and diastolic blood pressure. Only extremity temperature (adjusted odds ratio, 26.6; 95% CI, 15.5-45.8), capillary refill (adjusted odds ratio, 15.7; 95% CI, 7.9-31.3), and pulse strength (adjusted odds ratio, 21.3; 95% CI, 8.6-52.7) were associated with clinician-documented shock type. Of the 86 patients initiated on vasoactive medications during the pathway, shock type was discordant from vasoactive medication (κ, 0.14; 95% CI, -0.03 to 0.31) and shock type-vasoactive mismatch was not associated with complicated course (adjusted odds ratio, 0.3; 95% CI, 0.1-1.02). CONCLUSIONS: Agreement was low among common clinical signs used to characterize shock type, with clinicians prioritizing extremity temperature, capillary refill, and pulse strength. Although clinician-assigned shock type was often discordant with vasoactive choice, shock type-vasoactive mismatch was not associated with complicated course. Categorizing shock based on clinical signs should be done cautiously.

Providing Early Attending Physician Expertise via Telemedicine to Improve Rapid Response Team Evaluations.

OBJECTIVES: To evaluate the effect of providing early attending physician involvement via telemedicine to improve the decision process of rapid response teams. DESIGN: Quasi-experimental; three pairs of control/intervention months: June/July; August/October; November/December. SETTING: Single-center, urban, quaternary academic children's hospital with three-member rapid response team: critical care fellow or nurse practitioner, nurse, respiratory therapist. Baseline practice: rapid response team leader reviewed each evaluation with an ICU attending physician within 2 hours after return to ICU. SUBJECTS: 1) Patients evaluated by rapid response team, 2) rapid response team members. INTERVENTIONS: Implementation of a smartphone-based telemedicine platform to facilitate early co-assessment and disposition planning between the rapid response team at the patient's bedside and the attending in the ICU. MEASUREMENTS AND MAIN RESULTS: As a marker of efficiency, the primary provider outcome was time the rapid response team spent per patient encounter outside the ICU prior to disposition determination. The primary patient outcome was percentage of patients requiring intubation or vasopressors within 60 minutes of ICU transfer. There were three pairs of intervention/removal months. In the first 2 pairs, the intervention was associated with the rapid response team spending less time on rapid response team calls (June/July: point estimate -5.24 min per call; p < 0.01; August/October: point estimate -3.34 min per call; p < 0.01). During the first of the three pairs, patients were significantly less likely to require intubation or vasopressors within 60 minutes of ICU transfer (adjusted odds ratio, 0.66; 95 CI, 0.51-0.84; p < 0.01). CONCLUSIONS: Early in the study, more rapid ICU attending involvement via telemedicine was associated with rapid response team providers spending less time outside the ICU, and among patients transferred to the ICU, a significant decrease in likelihood of patients requiring vasopressors or intubation within the first 60 minutes of transfer. These findings provide evidence that early ICU attending involvement via telemedicine can improve efficiency of rapid response team evaluations.

Trends in Postoperative Opioid Prescribing in Outpatient Pediatric Surgery.

OBJECTIVE: To determine trends in opioid prescribing for home use after pediatric outpatient surgery. DESIGN: Retrospective analysis of a de-identified database. SETTING: Multispecialty children's hospital and freestanding surgery centers. PATIENTS, PARTICIPANTS: A total of 65,190 encounters of pediatric outpatient surgeries from 2013 through 2017 for nine different surgical specialties. Patients in the cardiothoracic service and nonpainful procedures were excluded. MAIN: Outcome Measures. Incidence rate of prescribing, dose, number of doses available (i.e., duration of therapy), and maximum weight-based home opioid availability from 2013 to 2017. Additional independent variables included sex, age, weight, race/ethnicity, insurance type (private vs public), and surgical service. RESULTS: The incidence rate of receiving a take-home opioid prescription at discharge ranged from 18% to 21% between 2013 and 2017, with no clear directional trend. Among patients prescribed opioids, however, the maximum available take-home dose steadily declined from 2013 through 2017 (P < 0.001). This was due to both a decrease in the number of doses prescribed (i.e., duration of treatment) and, beginning in 2015, the amount per dose. Females were more likely to receive an opioid than males, and patients with public insurance were more likely to receive an opioid than those with private insurance. Opioid prescribing was more likely in patients who did not disclose their ethnicity and those of ethnic minority compared with white patients (all P < 0.0001). CONCLUSIONS: The rate of receiving a take-home opioid prescription and the dose prescribed remained stable from 2013 to 2017, but the duration of treatment steadily declined, and beginning in 2015, the amount per dose also decreased. Certain subgroups of patients were more likely to be prescribed opioids and will require further investigation and confirmation.

Inter-Rater Reliability Between Critical Care Nurses Performing a Pediatric Modification to the Glasgow Coma Scale.

OBJECTIVES: Estimate the inter-rater reliability of critical care nurses performing a pediatric modification of the Glasgow Coma Scale in a contemporary PICU. DESIGN: Prospective observation study. SETTING: Large academic PICU. PATIENTS/SUBJECTS: All 274 nurses with permanent assignments in the PICU were eligible to participate. A subset of 18 nurses were selected as study registered nurses. All PICU patients were eligible to participate. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: PICU nurses were educated and demonstrated proficiency on a pediatric modification of the Glasgow Coma Scale we created to make it more applicable to a diverse PICU population that included patients who are sedated, mechanically ventilated, and/or have developmental disabilities. Each study registered nurse observed a sample of nurses perform the Glasgow Coma Scale, and they independently scored the Glasgow Coma Scale. Patients were categorized as having developmental disabilities if their preillness Pediatric Cerebral Performance Category score was greater than or equal to 3. Fleiss' Kappa (κ), intraclass correlation coefficient, and percent agreement assessed inter-rater reliability for each Glasgow Coma Scale component (eye, verbal, motor) and age-specific scale (≥ 2 and < 2-yr-old). The overall percent agreement between study registered nurses and nurses was 89% for the eye, 91% for the verbal, and 79% for the motor responses. Inter-rater reliability ranged from good (intraclass correlation coefficient = 0.75) to excellent (intraclass correlation coefficient = 0.96) for testable patients. Agreement on the motor response was significantly lower for children with developmental disabilities (< 2 yr: 59% vs 95%; p = 0.0012 and ≥ 2 yr: 55% vs 91%; p = 0.0012). Agreement was significantly worse for intermediate range Glasgow Coma Scale motor responses compared with responses at the extremes (e.g., motor responses 2, 3, 4 vs 1, 5, 6; p < 0.05). CONCLUSIONS: A pediatric modification of the Glasgow Coma Scale performed by trained PICU nurses has excellent inter-rater reliability, although reliability was reduced in patients with developmental disabilities and for intermediate range Glasgow Coma Scale responses. Further research is needed to determine the effectiveness of this Glasgow Coma Scale modification to detect clinical deterioration.

Guide to the statistical analysis plan.

Biomedical research has been struck with the problem of study findings that are not reproducible. With the advent of large databases and powerful statistical software, it has become easier to find associations and form conclusions from data without forming an a-priori hypothesis. This approach may yield associations without clinical relevance, false positive findings, or biased results due to "fishing" for the desired results. To improve reproducibility, transparency, and validity among clinical trials, the National Institute of Health recently updated its grant application requirements, which mandates registration of clinical trials and submission of the original statistical analysis plan (SAP) along with the research protocol. Many leading journals also require the SAP as part of the submission package. The goal of this article and the companion article detailing the SAP of an actual research study is to provide a practical guide on writing an effective SAP. We describe the what, why, when, where, and who of a SAP, and highlight the key contents of the SAP.

Statistical Analysis Plan for "An international multicenter study of isoelectric electroencephalography events in infants and young children during anesthesia for surgery".

This Statistical Analysis Plan details the statistical procedures to be applied for the analysis of data for the multicenter electroencephalography study. It consists of a basic description of the study in broad terms and separate sections that detail the methods of different aspects of the statistical analysis, summarized under the following headings (a) Background; (b) Definitions of protocol violations; (c) Definitions of objectives and other terms; (d) Variables for analyses; (e) Handling of missing data and study bias; (f) Statistical analysis of the primary and secondary study outcomes; (g) Reporting of study results; and (h) References. It serves as a template for researchers interested in writing a Statistical Analysis Plan.