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Abstract Precision medicine is expected to impact the care of people with asthma, given its high disease prevalence, heterogeneity of pathophysiologic mechanisms, and consequent clinical phenotypes. A novel phenotype-stratified clinical trial conducted by the NHLBI AsthmaNet Consortium, titled Steroids in Eosinophil Negative Asthma (SIENA), was a randomized, multicenter, clinical trial that prospectively stratified individuals according to their baseline level of sputum inflammation during a screening period. Two phenotypic strata were assigned based on an a priori defined extent of sputum eosinophilia (Eos Low versus Eos High). This article describes: the scientific premise for the trial design, including assumptions used for power calculations; modifications to the analysis plan implemented after the trial started due to a higher than expected prevalence of one phenotypic stratum which impacted the ability to accrue sufficient subjects within the planned budget and study period; investigator alternatives to address the strata imbalance weighing scientific impact and study feasibility; and the final modified SIENA study design and analysis plan. SIENA was successfully completed in a manner that maintained meaningful outcomes. We conclude with recommendations for incorporation of pre-specified contingency plans into phenotype-directed protocols, to address the potential for differences in observed compared to estimated prevalence of different phenotypes in a study population. These approaches can be applied to precision medicine trials for the future. [ABSTRACT FROM AUTHOR]

Objective/Background: Positive airway pressure (PAP) is highly efficacious treatment but nonadherence is prevalent with little improvement over the last 15 years. Tailored interventions show promise for promoting adherence to other treatments. The study objective was to examine feasibility and acceptability of a tailored intervention to promote PAP adherence. Participants: The convenience sample met inclusion criteria: newly diagnosed OSA; treatment-naïve; ≥ 18 years. Exclusion criteria: previous obstructive sleep apnea (OSA) diagnosis and treatment; new psychiatric diagnosis; use of oxygen/bilevel PAP; secondary sleep disorder. Adults (n = 118) were randomized to tailored intervention (TI; n = 61) or usual care (UC; n = 57); application of a priori exclusion criteria resulted in 30 participants per assignment who were middle-aged (51.3 ± 11.1 years) adults (70% male) with severe OSA (apnea hypopnea index [AHI], 35.9 ± 25.2). Methods: Randomized, double-blind, single-site pilot controlled trial. A multiphased tailored intervention targeting social cognitive perceptions of OSA-PAP treatment was delivered at four intervals. Descriptive analysis, group differences, and self-efficacy change scores by t-test, and thematic analysis of acceptability data are reported. Results: One-week PAP use among TI was 35 min greater than UC condition (p = 0.20; Cohen's d = 0.336). Treatment use decreased at 1 month and 3 months (NS). Per-protocol delivery of face-to-face intervention delivery was 100% but lower for telephone intervention delivery. Personalized approach was valued by participants. Conclusions: A tailored intervention approach is acceptable to participants and feasibly implemented in a clinical sleep center setting. The intervention effect size at 1 week is consistent with other educational PAP adherence interventions but was not sustained; further pilot testing is warranted to address pilot RCT limitations. [ABSTRACT FROM AUTHOR]

The 2013 US Preventive Services Task Force report found insufficient evidence for pediatric blood pressure screening. This retrospective study evaluated the reliability of successive annual blood pressure screening of children for hypertension at the 3-, 4-, and 5-year-old health maintenance visits (January 1, 2010 to June 18, 2014). Of 328 patients, 290 (88%) were normotensive at all 3 visits. All elevated blood pressures (≥95th percentile) were stage 1. No patient was hypertensive (3 elevated measures). The extended concordance correlation coefficient indicated poor agreement for systolic (0.19, 95% CI −0.49 to 0.72) and diastolic (0.11, 95% CI −0.39 to 0.56) measurements. Blood pressure at the 3-year (κ −0.008, 95% CI −0.11 to 0.09), 4-year (κ 0.09, 95% CI −0.06 to 0.24), or 5-year (κ 0.08, 95% CI −0.05 to 0.20) visit was not associated with elevated blood pressures at the other 2 time points. In the preschool years, stage 1 elevated blood pressures do not correlate with hypertension and may be better managed by watchful waiting and parental reassurance. [ABSTRACT FROM AUTHOR]

Importance: In asthma and other diseases, vitamin D insufficiency is associated with adverse outcomes. It is not known if supplementing inhaled corticosteroids with oral vitamin D3 improves outcomes in patients with asthma and vitamin D insufficiency.Objective: To evaluate if vitamin D supplementation would improve the clinical efficacy of inhaled corticosteroids in patients with symptomatic asthma and lower vitamin D levels.Design, Setting, and Participants: The VIDA (Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma) randomized, double-blind, parallel, placebo-controlled trial studying adult patients with symptomatic asthma and a serum 25-hydroxyvitamin D level of less than 30 ng/mL was conducted across 9 academic US medical centers in the National Heart, Lung, and Blood Institute's AsthmaNet network, with enrollment starting in April 2011 and follow-up complete by January 2014. After a run-in period that included treatment with an inhaled corticosteroid, 408 patients were randomized.Interventions: Oral vitamin D3 (100,000 IU once, then 4000 IU/d for 28 weeks; n = 201) or placebo (n = 207) was added to inhaled ciclesonide (320 µg/d). If asthma control was achieved after 12 weeks, ciclesonide was tapered to 160 µg/d for 8 weeks, then to 80 µg/d for 8 weeks if asthma control was maintained.Main Outcomes and Measures: The primary outcome was time to first asthma treatment failure (a composite outcome of decline in lung function and increases in use of β-agonists, systemic corticosteroids, and health care).Results: Treatment with vitamin D3 did not alter the rate of first treatment failure during 28 weeks (28% [95% CI, 21%-34%] with vitamin D3 vs 29% [95% CI, 23%-35%] with placebo; adjusted hazard ratio, 0.9 [95% CI, 0.6-1.3]). Of 14 prespecified secondary outcomes, 9 were analyzed, including asthma exacerbation; of those 9, the only statistically significant outcome was a small difference in the overall dose of ciclesonide required to maintain asthma control (111.3 µg/d [95% CI, 102.2-120.4 µg/d] in the vitamin D3 group vs 126.2 µg/d [95% CI, 117.2-135.3 µg/d] in the placebo group; difference of 14.9 µg/d [95% CI, 2.1-27.7 µg/d]).Conclusions and Relevance: Vitamin D3 did not reduce the rate of first treatment failure or exacerbation in adults with persistent asthma and vitamin D insufficiency. These findings do not support a strategy of therapeutic vitamin D3 supplementation in patients with symptomatic asthma.Trial Registration: clinicaltrials.gov Identifier: NCT01248065. [ABSTRACT FROM AUTHOR]

IMPORTANCE In asthma and other diseases, vitamin D insufficiency is associated with adverse outcomes. It is not known if supplementing inhaled corticosteroids with oral vitamin D3 improves outcomes in patients with asthma and vitamin D insufficiency. OBJECTIVE To evaluate if vitamin D supplementation would improve the clinical efficacy of inhaled corticosteroids in patients with symptomatic asthma and lower vitamin D levels. DESIGN, SETTING, AND PARTICIPANTS The VIDA (Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma) randomized, double-blind, parallel, placebo-controlled trial studying adult patients with symptomatic asthma and a serum 25-hydroxyvitamin D level of less than 30 ng/mL was conducted across 9 academic US medical centers in the National Heart, Lung, and Blood Institute's AsthmaNet network, with enrollment starting in April 2011 and follow-up complete by January 2014. After a run-in period that included treatment with an inhaled corticosteroid, 408 patients were randomized. INTERVENTIONS Oral vitamin D3 (100 000 IU once, then 4000 IU/d for 28 weeks; n = 201) or placebo (n = 207) was added to inhaled ciclesonide (320 µg/d). If asthma control was achieved after 12 weeks, ciclesonide was tapered to 160 µg/d for 8 weeks, then to 80 µg/d for 8 weeks if asthma control was maintained. MAIN OUTCOMES AND MEASURES The primary outcome was time to first asthma treatment failure (a composite outcome of decline in lung function and increases in use of β-agonists, systemic corticosteroids, and health care). RESULTS Treatment with vitamin D3 did not alter the rate of first treatment failure during 28 weeks (28%[95% CI, 21%-34%] with vitamin D3 vs 29%[95% CI, 23%-35%] with placebo; adjusted hazard ratio, 0.9 [95% CI, 0.6-1.3]). Of 14 prespecified secondary outcomes, 9 were analyzed, including asthma exacerbation; of those 9, the only statistically significant outcome was a small difference in the overall dose of ciclesonide required to maintain asthma control (111.3 µg/d [95% CI, 102.2-120.4 µg/d] in the vitamin D3 group vs 126.2 µg/d [95% CI, 117.2-135.3 µg/d] in the placebo group; difference of 14.9 µg/d [95% CI, 2.1-27.7 µg/d]). CONCLUSIONS AND RELEVANCE Vitamin D3 did not reduce the rate of first treatment failure or exacerbation in adults with persistent asthma and vitamin D insufficiency. These findings do not support a strategy of therapeutic vitamin D3 supplementation in patients with symptomatic asthma. [ABSTRACT FROM AUTHOR]

The concordance correlation coefficient is commonly used to assess agreement between two raters or two methods of measuring a response when the data are measured on a continuous scale. However, the situation may arise in which repeated measurements are taken for each rater or method, e.g. longitudinal studies in clinical trials or bioassay data with subsamples. This paper proposes a coefficient for measuring agreement between two raters or two methods of measuring a response in the presence of repeated measurements. We illustrate the methodology with examples comparing (1) 1-hr versus 2-hr blood draws for measuring cortisol in an asthma clinical trial and (2) two measurements of percentage body fat, from skinfold calipers and dual energy X-ray absorptiometry. Copyright © 2007 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

OBJECTIVE:: Prospectively validate an antenatal bacterial vaginosis (BV) risk score at two public health department obstetrics clinics. STUDY DESIGN:: Women (n=409) entering prenatal care received a BV risk score (range 0 to 16) at their first visit and at 24 to 28 weeks'gestation. BV was measured with Gram-stained vaginal smears. Normal discharge was used as a surrogate for being asymptomatic. RESULTS:: Approximately half of the women scored=3 at each assessment. In total 29%had true BV at the first assessment (13%at the second assessment). The BV risk score (=3) had 91%sensitivity and 63%specificity, and the BV risk score (=5) had 88%sensitivity and 76%specificity. Among true cases, 42%were asymptomatic, of which 77%had risk scores=3. All symptomatic BV cases had risk scores=3. CONCLUSION:: In practice, the risk score identified both asymptomatic and symptomatic cases. Asymptomatic women are of particular interest because they are not screened for BV under current practice guidelines.Journal of Perinatology (2004) 24, 735-742. doi:10.1038/sj.jp.7211179 Published online 12 August 2004 [ABSTRACT FROM AUTHOR]

The goal of this study was to examine the impact of inpatient- or emergency department- prescribed antibiotic treatment in combination with opioids on the risk of developing opioid use disorder 12 months following discharge from the hospital. The authors conducted a propensity score-matched cohort study with data from the TriNetX Research Network database to identify adult subjects (18–65 years old) with no previous history of an opioid use disorder. Three cohorts were defined for the analyses: subjects who were prescribed an opioid, opioid in combination with an antibiotic, or an antibiotic while in the emergency department or inpatient unit, from the years 2012 to 2018. The diagnosis of an Opioid Related Disorder (F11.10–F11.20) 12 months following discharge from the emergency department or inpatient unit was then observed within the cohorts following the index event as identified by the ICD-10 procedural coding system. Primary analysis (propensity-score matched on age and sex) showed that opioids prescribed in combination with antibiotics had a protective effect against the development of opioid use disorder. This effect was consistent throughout all of the years included in this study with the smallest protective effect observed in 2018 (2012 risk ratio = 1.27 (95% CI: 1.23, 1.32); 2018 risk ratio: 1.03 (95% CI: 1.01, 1.05). These findings suggest that opioids prescribed in combination with antibiotics in the hospital setting are protective against the development of OUD at later time points following hospital discharge. [ABSTRACT FROM AUTHOR]

This article, published in the Journal of Neurological Surgery, examines the use of fibrin sealants in reducing postoperative complications in skull base surgery. The study conducted a systematic review and meta-analysis of published studies that assessed patients who had undergone skull base surgery with the use of fibrin sealants. The results showed that patients who received fibrin sealants had a lower incidence of postoperative cerebrospinal fluid (CSF) leak and drain placement compared to those who did not receive fibrin sealants. However, there was no significant difference in the incidence of revision surgery or infection between the two groups. Overall, the findings suggest that fibrin sealants may be effective in reducing CSF leaks and related complications in skull base surgery. [Extracted from the article]

Positive airway pressure (PAP) associated claustrophobia is common among obstructive sleep apnea patients and plays a prominent role in low adherence and treatment failure. As there are no evidence-based interventions for PAP-associated claustrophobia, the objective of the present research is to pilot test Mindfulness-based Exposure for PAP-associated Claustrophobia, in sleep apnea adults that present with treatment non-adherence and claustrophobia. This approach combines Mindfulness-based Stress Reduction with exposure-based treatment components to target this treatment-associated claustrophobia. The present article outlines the mindfulness exposure intervention design and methods and reports the pilot trial study protocol. Trial findings are intended to: (a) develop a preliminary effect size of the intervention on PAP-associated claustrophobia; (b) explore differences in treatment adherence by group (intervention vs control); and (c) establish feasibility for expanded protocol implementation, delivery, and participant acceptability of the intervention to support subsequent design of a fully powered randomized controlled trial. [ABSTRACT FROM AUTHOR]

Introduction: Two major techniques are used to repair complete quadriceps tendon ruptures, transosseous tunnel (TT) and the suture anchor (SA). There are multiple studies comparing the biomechanical outcomes of repairs performed with TT or SA. Our purpose was to compare the clinical outcomes following quadriceps tendon repair using SA and TT fixation techniques.Methods: Three major search engines were used with predetermined keyword searches to perform a systematic review of literature. These studies were independently scanned by two reviewers using PRISMA criterion. All included studies had to include at least one of the following outcome measures: range of motion (ROM), Lysholm score, complications, and/or re-ruptures.Results: Using three major search engines, 1039 articles were identified. After removing duplicates and screening for inclusion, 49 articles were reviewed. Two independent reviewers searched the studies to meet the inclusion criteria, and eight studies were selected. These eight studies included 156 knees in the TT group and 54 knees in the SA group. The TT group had a significantly better ROM after QT repair (132.5° versus 127.0°, p = 0.02). There was no significant difference in Lysholm scores between the TT group (92.6) and SA group (91.0, p = 0.11). There were significantly more complications in SA groups (9.3% versus 1.3%, p = 0.013), but not a significant difference in re-rupture rate between those undergoing SA vs. TT repair (3.7% versus 0%, p = 0.065). The SA group had a significantly higher age at time of surgery (63.62 vs. 54.32) CONCLUSION: The current study suggests that, following quadriceps tendon rupture, there are no significant differences in functional outcome between TT and SA techniques. Those undergoing TT repair attained a statistically significantly greater final ROM but this difference may not be clinically relevant. There was a statistically significantly higher rate of post-operative complications using SA technique. [ABSTRACT FROM AUTHOR]

Objective: Identify risk factors and perioperative morbidity for pediatric patients undergoing septoplasty. Methods: The American College of Surgeons National Surgical Quality Improvement Program Pediatric (NSQIP-P) database was retrospectively queried to identify patients who underwent septoplasty (CPT 30520) for a diagnosis of deviated nasal septum (ICD J34.2) from 2018 to 2019. Outcomes analyzed include patient demographics, medical comorbidities, surgical setting, operative characteristics, length of stay, and postoperative outcomes. Results: A total of 729 children were identified. Median age at time of surgery was 15.8 years, with most patients (82.8%) >12 years of age; no significant association was identified between age at time of surgery and adverse surgical outcomes. Overall, postoperative complications were uncommon (0.6%), including readmission (0.4%), septic shock (0.1%), and surgical site infection (0.1%). A history of asthma was found to be a significant risk factor for postoperative complications (P =.035) as well as BMI (P =.028). Conclusion: The 30-day postoperative complications following pediatric septoplasty in children reported in the NSQIP-P database are infrequent. Special considerations regarding young age, complex sinonasal anatomy, and surgical technique remain important features in considering corrective surgery for the pediatric nose and certainly warrant further investigation in subsequent studies. [ABSTRACT FROM AUTHOR]

Objectives Endoscopic endonasal anterior skull base surgery has expanding use in the pediatric population, but the anatomy of pediatric patients can lead to limitations. This study aims to characterize the important anatomical implications of the pediatric skull base using computed tomography (CT) scans. Design This study is designed as retrospective analysis. Setting The study setting comprises of tertiary academic medical center. Participants In total, 506 patients aged 0 to 18 who had undergone maxillofacial and or head CTs between 2009 to 2016 were involved. Methods Measurements included piriform aperture width, nare to sella distance (NSD), sphenoid pneumatization, olfactory fossa depth, lateral lamella cribriform plate angles, and intercarotid distances (ICD) at the superior clivus and cavernous sinus. These patients were then subdivided into three age groups adjusting for sex. Analysis of covariance (ANCOVA) models were fit comparing between all age groups and by sex. Results Piriform aperture width, NSD, sphenoid sinus pneumatization as measured using lateral aeration and anterior sellar wall thickness, olfactory fossa depth, and ICD at the cavernous sinus were significantly different among all age groups (p <0.0001). Our results show that mean piriform aperture width increased with each age group. The mean olfactory fossa depth also had consistent age dependent growth. In addition, ICD at the cavernous sinus showed age dependent changes. When comparing by sexes, females consistently showed smaller measurements. Conclusion The process of skull base development is age and sex dependent. During preoperative evaluation of pediatric patients for skull base surgery piriform aperture width, sphenoid pneumatization in both the anterior posterior and lateral directions, and ICD at the cavernous sinus should be carefully reviewed. [ABSTRACT FROM AUTHOR]

To compare the accuracy of preoperative biometry-based formulas to intraoperative aberrometry (IA) with respect to predicting refractive outcomes after cataract surgery in short eyes. Private practice and community-based ambulatory surgery center. Retrospective consecutive case series. Eyes with an axial length (AL) shorter than 22.1 mm underwent cataract extraction and intraocular lens (IOL) implantation. The predicted residual refractive error was calculated preoperatively using Hoffer Q, Holladay 2, Haigis, Barrett Universal II, and Hill-RBF formulas and intraoperatively using IA. The postoperative spherical equivalent (SE) was compared with the predicted SE to evaluate the accuracy of each aforementioned method. Fifty-one eyes from 38 patients met criteria to be included in the analysis. Without optimizing the formulas specifically for short eyes, the mean numerical errors (MNEs) associated with Hoffer Q, Holladay 2, Haigis, Barrett Universal II, Hill-RBF, and IA were −0.08 (95% confidence interval [CI], −0.30 to 0.13), −0.14 (95% CI, −0.35 to 0.07), +0.26 (95% CI, 0.05 to 0.47), +0.11 (95% CI, −0.10 to 0.32), +0.07 (95% CI, −0.14 to 0.28), and +0.00 (95% CI, −0.21 to 0.21), respectively (P <.001). The proportion of eyes within ±0.5 diopter (D) of the predicted SE were 49.0%, 43.1%, 52.9%, 52.9%, 60.8%, and 58.8%, respectively (P =.06). The prediction outcomes from IA were statistically better than Haigis, but not other formulas. When formula and IA predictions differed by 0.5 D or more, IA's ability to recommend a more emmetropic outcome was no better than chance (50%). Intraoperative aberrometry is not significantly different from the best preoperative biometry-based methods available for IOL power selection in short eyes. [ABSTRACT FROM AUTHOR]

Context.-- Recent data support that low-risk submucosally invasive (pT1) colonic adenocarcinomas (ie, completely resected tumors that lack high-grade morphology, tumor budding, and lymphovascular invasion) are considered cured via endoscopic resection, provided that the submucosal invasion is less than 1000 μm. Hence, the pathologists' assessment of depth of submucosal invasion may guide further management (ie, surveillance versus colectomy). Objective.-- To assess interobserver concordance among gastrointestinal pathologists in measuring submucosal depth of invasion in colonic endoscopic resections. Design.-- Six gastrointestinal pathologists from 5 academic centers independently measured the greatest depth of submucosal invasion in micrometers on 52 hematoxylin-eosin-stained slides from colonic endoscopic specimens with pT1 adenocarcinomas, per published guidelines (round 1 scoring). Two separate measurements (round 2 scoring) were subsequently performed by each pathologist following a consensus meeting, (1) from the surface of the lesion and (2) from the muscularis mucosae, and pathologists were asked to choose their (3) "real-life (best)" assessment between the first 2 measurements. Interobserver agreement was assessed by the intraclass correlation coefficient (ICC) and Cohen κ statistics. Results.-- Round 1 had poor ICC (0.43; 95% CI, 0.31-0.56). Round 2 agreement was good when measuring from the surface (ICC = 0.83; 95% CI, 0.76-0.88) but moderate (ICC = 0.59; 95% CI, 0.47-0.70) when measuring from the muscularis mucosae and became poor (ICC = 0.49; 95% CI, 0.36-0.61) for the best-assessment measurement. Conclusions.-- Our findings indicate that clearer and reproducible guidelines are needed if clinical colleagues are to base important management decisions on pathologists' estimate of the depth of submucosal invasion in colonic endoscopic resections. [ABSTRACT FROM AUTHOR]

The American Academy of Pediatrics has previously expressed concerns about the thematic content of television (TV) and the amount of time children spend viewing TV. The objective of this study was to determine the positive and negative themes depicted in a select number of TV shows targeted toward adolescents. We analyzed the thematic content depicted in the first season of 26 Netflix TV shows. The mean occurrences/h for positive and negative themes were 39.53 and 47.20, respectively. The most common positive themes were "encouragement from a friend/peer," "demonstrating honesty," and "staying true to oneself" (5.98, 5.38, and 3.72 mean occurrences/h, respectively). The most common negative themes were "dishonesty," "cursing," and "selfishness," (5.30, 4.96, and 4.85 mean occurrences/h, respectively). We suggest that health care providers become aware of TV thematic content and promote media education, and we encourage co-viewing and active mediation by parents/guardians with their children. [ABSTRACT FROM AUTHOR]

Sport participation is an important part of the development of children and adolescents in the United States. The objective of this study was to determine positive and negative themes found in a selected number of sport-related films. A total of 44 sport-related films were independently viewed and analyzed by four reviewers. The most common sports depicted were baseball (27%) and football (25%). The most common positive themes were positive interactions with the coach, positive interactions with family and friends, and positive interactions with teammates (2.04, 1.42, 1.2 mean events per hour). The most common negative themes were taunting/fighting/poor sportsmanship, negative interactions with the coach, and drinking/smoking/drug use (2.13, 1.10, 0.94 mean events per hour). In conclusion, the coviewing of sport films among pediatric athletes and their coaches, athletic trainers, and/or parents in order to focus on “teachable moments” may encourage the acquisition and development of positive themes and the avoidance and de-emphasis of negative themes. [ABSTRACT FROM AUTHOR]

Introduction: Osgood–Schlatter disease (OSD) is a common cause of anterior knee pain in adolescent athletes due to repetitive stress on the tibial tubercle. The posterior tibial slope angle (PTSA) and the Insall–Salvati Index (ISI) play a role in knee biomechanics. However, to our knowledge, the posterior tibial slope and patellar height have not been compared in operated versus nonoperative OSD patients. The purpose of the current study is to compare the differences in the PTSA and the ISI between operative and nonoperative patients with OSD. Materials and methods: The study was approved by the College of Medicine's Institutional Review Board. A retrospective review was performed on 75 adolescent athletes with OSD between 2008 and 2019. The data extracted included: age, sex, body mass index (BMI), sporting activity and type, mechanism of injury (MOI), chronicity of symptoms, PTSA, and the ISI. Descriptive and quantitative statistics were used. Results: Seventy-five patients (88 knees) with OSD were studied (28 boys, 47 girls). The average age was 12.2 years and the average BMI was 22.3. The mechanism of injury (MOI) included repetitive stress (77%) and trauma (23%). The duration of knee pain averaged 10.3 months. Sixty-six patients were included in the nonoperative cohort. Nine patients were included in the operative cohort and underwent surgery due to persistent symptoms after skeletal maturity with tubercleplasty and/or ossicle excision. The average PTSA was 12.1° ± 1.7° and average ISI was 1.05 ± 0.15. Comparing the operative and nonoperative patients, we found no significant difference in PTSA (11.2° ± 0.73° versus 12.8° ± 1.8°, p < 0.064). However, we did find that patients treated operatively had a lower ISI (0.95 ± 0.18 versus 1.14 ± 0.13, p < 0.001). Conclusion: In patients with OSD, operative and nonoperative patients demonstrated a similar PTSA. On the other hand, the ISI was higher in nonoperative patients. In the current paper, a decreased ISI was helpful in predicting the need for operative intervention in symptomatic patients after skeletal maturity. [ABSTRACT FROM AUTHOR]

The article presents a study related to the analysis of the failure of office-based hearing screening questions for identifying adolescents at risk for hearing loss. It reveals that under the study, utility of questions by clinicians to identify high risk patient for hearing loss decided by Bright Futures, disease prevention initiative, and the American Academy of Pediatrics, was analysed. The result concluded that questions of Bright Futures were not associated with adolescent hearing loss.

The article presents a randomized clinical trial, Best Adjustment Strategy for Asthma in the Long Term (BASALT) to determine the adjustments of inhaled corticosteroid therapy in preventing treatment failure in adults with mild to moderate asthma. The study concluded that the adults with mild to moderate persistent asthma controlled with low-dose inhaled corticosteroid therapy. It is suggested to use symptom-based adjustment strategies because it is simple to use and empower patients.

Background: Asthma is a heterogeneous disease with variability among patients in characteristics such as lung function, symptoms and control, body weight, markers of inflammation, and responsiveness to glucocorticoids (GC). Cluster analysis of well-characterized cohorts can advance understanding of disease subgroups in asthma and point to unsuspected disease mechanisms. We utilized an hypothesis-free cluster analytical approach to define the contribution of obesity and related variables to asthma phenotype. Methodology and Principal Findings: In a cohort of clinical trial participants (n = 250), minimum-variance hierarchical clustering was used to identify clinical and inflammatory biomarkers important in determining disease cluster membership in mild and moderate persistent asthmatics. In a subset of participants, GC sensitivity was assessed via expression of GC receptor alpha (GCRα) and induction of MAP kinase phosphatase-1 (MKP-1) expression by dexamethasone. Four asthma clusters were identified, with body mass index (BMI, kg/m²) and severity of asthma symptoms (AEQ score) the most significant determinants of cluster membership (F = 57.1, p<0.0001 and F = 44.8, p<0.0001, respectively). Two clusters were composed of predominantly obese individuals; these two obese asthma clusters differed from one another with regard to age of asthma onset, measures of asthma symptoms (AEQ) and control (ACQ), exhaled nitric oxide concentration (FENO) and airway hyperresponsiveness (methacholine PC20) but were similar with regard to measures of lung function (FEV1 (%) and FEV1/FVC), airway eosinophilia, IgE, leptin, adiponectin and C-reactive protein (hsCRP). Members of obese clusters demonstrated evidence of reduced expression of GCRα, a finding which was correlated with a reduced induction of MKP-1 expression by dexamethasone Conclusions and Significance: Obesity is an important determinant of asthma phenotype in adults. There is heterogeneity in expression of clinical and inflammatory biomarkers of asthma across obese individuals. Reduced expression of the dominant functional isoform of the GCR may mediate GC insensitivity in obese asthmatics. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To determine if a single application of a vapor rub (VR) or petrolatum is superior to no treatment for nocturnal cough, congestion, and sleep difficulty caused by upper respiratory tract infection. METHODS: Surveys were administered to parents on 2 consecutive days-on the day of presentation when no medication had been given the previous evening, and the next day when VR ointment, petrolatum ointment, or no treatment had been applied to their child's chest and neck before bedtime according to a partially double-blinded randomization scheme. RESULTS: There were 138 children aged 2 to 11 years who completed the trial. Within each study group, symptoms were improved on the second night. Between treatment groups, significant differences in improvement were detected for outcomes related to cough, congestion, and sleep difficulty; VR consistently scored the best, and no treatment scored the worst. Pairwise comparisons demonstrated the superiority of VR over no treatment for all outcomes except rhinorrhea and over petrolatum for cough severity, child and parent sleep difficulty, and combined symptom score. Petrolatum was not significantly better than no treatment for any outcome. Irritant adverse effects were more common among VR-treated participants. CONCLUSIONS: In a comparison of VR, petrolatum, and no treatment, parents rated VR most favorably for symptomatic relief oftheir child's nocturnal cough, congestion, and sleep difficulty caused by upper respiratory tract infection. Despite mild irritant adverse effects, VR provided symptomatic relief for children and allowed them and their parents to have a more restful night than those in the other study groups. [ABSTRACT FROM AUTHOR]

Sport participation is an important part of the development of children and adolescents. The objective of this study was to identify and quantify themes depicted in a select number of running-related films. Thirty-one running-related films were independently viewed and analyzed by 4 reviewers. The number of positive and negative themes was 29.5 (95% confidence interval = 26.1-33.4) and 9.0 (95% confidence interval = 7.9-10.2) mean events per hour for all included films, respectively. The most common positive themes were "overcoming physical limitations," "overcoming mental obstacles," and "encouragement from family/friends/fans" (2.6, 2.4, and 2.3 mean events per hour, respectively). The most common negative themes were "giving up/losing confidence," "ignoring injuries," and "discouragement/ridicule from coach/athletic trainer" (1.2, 1.1, and 0.66 mean events per hour, respectively). In conclusion, the co-viewing of running-related films with pediatric athletes in order to focus on "teachable moments" may encourage the acquisition and development of positive themes and the avoidance and de-emphasis of negative themes. [ABSTRACT FROM AUTHOR]

Background/Purpose: Improving PAP treatment adherence is imperative to reducing OSA health risks. We pilot tested a complex, tailored intervention to determine (1) intervention effect size for PAP adherence at 1-week (primary), 1-month (mos), and 3-mos; and (2) intervention feasibility/acceptability. Theoretical Framework: Social cognitive theory guided tailored intervention design and selection of tailoring critical indicator. Methods: Randomized, double-blind, pilot controlled trial with a convenience sample of adults referred to polysomnography (PSG) with inclusion criteria: (1) OSA with apnea hypopnea index (AHI) > 10 events/hour; (2) PAP-naive; (3) adults ≥ 18 years. Exclusion criteria: (1) prior OSA diagnosis/treatment; (2) EMR-documented new psychiatric diagnosis within 6-mos of enrollment; (3) oxygen or bi-level positive airway pressure; (4) PSG diagnosis of secondary sleep disorder. Adults (n=118) were randomized to tailored intervention (TI; n=61) or usual care (UC; n=57). After randomization, participants were excluded per criteria (TI, n=31; UC, n=27) resulting in complete exposure/data (n=30 per group). Middle-aged (mean 51.3 yrs) adults (70% male) with severe OSA (mean AHI 35.9 events/hour) participated. A complex tailored intervention, targeting social cognitive perceptions of OSA and PAP treatment, was delivered at OSA diagnosis, first exposure to PAP, and during first week home PAP use. A critical indicator guided intervention tailoring. Outcomes: objective PAP use; per-protocol intervention fidelity; participant acceptability of exposure condition. Descriptive analysis, effect size, group differences and change scores by t-test, and thematic analysis of acceptability data are reported. Results: 1-week PAP use for TI group was 35 minutes greater than for UC group (p=0.20; Cohen's d effect size 0.336). PAP use attenuation was observed for both groups at 1-mos and 3-mos (NS). Per-protocol delivery of face-to-face intervention activities was 100%; per-protocol delivery of telephone intervention activities was lower (PAP treatment Day 2 fidelity= 43.3%; Day 7 fidelity= 23.3%). Personalized approach to OSA diag-nosis/PAP treatment was highly valued. Conclusions/Implications: A tailored intervention to promote PAP adherence resonates with patient expectations for personalized healthcare. Effect size is consistent with prior published PAP adherence intervention studies; alternative intervention delivery approaches for home treatment period are recommended. Further testing requires use of pilot study results for a high fidelity clinical trial to test overall efficacy of the intervention. [ABSTRACT FROM AUTHOR]

Films continue to be a popular form of entertainment among children. The objective of this study was to determine the most common themes found in the top-grossing films released from 2005 to 2015. Forty-five films were independently viewed and analyzed by 5 reviewers. The most common positive themes were “importance of helping others,” “working as a team,” and “standing up for what you believe in” (5.71, 4.08, and 3.78 mean events per hour, respectively). The most common negative themes were “use of guns/knives/lethal weapons,” “acts of violence/fighting,” and “demonstrating excessive anger” (5.78, 5.64, and 3.09 mean events per hour, respectively). In conclusion, the most common positive themes in our sample were associated with service, collaboration, and courage, and the most common negative themes were associated with violence. We encourage co-viewing and active mediation, focusing on the positive and negative themes found in film, as a method to guide children through their development process. [ABSTRACT FROM AUTHOR]

Superhero films have become incredibly popular. The objective of this study was to determine the positive and negative themes found in a select number of superhero films. A total of 30 superhero films were analyzed. The average numbers of positive and negative themes were 19.4 and 29.5 mean events per hour for all included films, respectively. The most common positive themes were “assisting others/protecting the public,” “positive relationships with family/friends,” and “teamwork/collaboration.” The most common negative themes were “acts of violence/fighting,” “use of guns/knives/lethal weapons,” and “bullying/intimidation/torture.” Based on the superhero films included in our study, the number of negative themes, especially acts of violence, outweighs positive themes. Although an exposure to positive themes found in superhero films may be beneficial to the development of children, pediatric health care providers should counsel children and their families in an attempt to limit their exposure to violence. [ABSTRACT FROM AUTHOR]

Purpose To compare the accuracy of intraoperative wavefront aberrometry (ORA) and the Hill-radial basis function (RBF) formula with other formulas based on preoperative biometry in predicting residual refractive error after cataract surgery in eyes with axial myopia. Setting Private practice, Harrisburg, Pennsylvania, USA. Design Retrospective consecutive case series. Methods Eyes with an axial length (AL) greater than 25.0 mm had cataract extraction with intraocular lens implantation. For each eye, the 1-center Wang-Koch AL-optimized Holladay 1 formula was used to select an IOL targeting emmetropia. Residual refractive error was predicted preoperatively using the SRK/T, Holladay 1 and 2, Barrett Universal II, and Hill-RBF formulas and intraoperatively using wavefront aberrometry. The postoperative refraction was compared with the preoperative and intraoperative predictions. Results The study comprised 37 patients (51 eyes). The mean numerical errors ± standard error associated with using the SRK/T, Holladay 1, AL-optimized Holladay 1, Holladay 2, Barrett Universal II, and Hill-RBF formulas and intraoperative wavefront aberrometry were 0.20 ± 0.06 diopters (D), 0.33 ± 0.06 D, −0.02 ± 0.06 D, 0.24 ± 0.06 D, 0.19 ± 0.06 D, 0.22 ± 0.06 D, and 0.056 ± 0.06 D, respectively ( P < .001). The proportion of patients within ±0.5 D of the predicted error was 74.5%, 62.8%, 82.4%, 79.1%, 73.9%, 76.7%, and 80.4%, respectively ( P = .090). Hyperopic outcomes occurred in 70.6%, 76.5%, 49.0%, 74.4%, 76.1%, 74.4%, and 45.1% of the eyes, respectively ( P = .007). Conclusions Intraoperative wavefront aberrometry was better than all formulas based on preoperative biometry and as effective as the AL-optimized Holladay 1 formula in predicting residual refractive error and reducing hyperopic outcomes. The Hill-RBF formula's performance was similar to that of the fourth-generation formulas. [ABSTRACT FROM AUTHOR]

Study Objective: Back injuries are a highly reported category of occupational injury in the health care setting. The daily clinical activities of an anesthesia provider, including lifting, pushing stretchers, transferring patients, and bending for procedures, are risk factors for developing low back pain. The purpose of this study is to investigate the prevalence of work related low back pain in anesthesia providers.Design/setting: We conducted a cross-sectional survey study of anesthesia providers at an academic institution.Patients: The target population included all 141 clinical anesthesia providers employed by the Penn State Milton S. Hershey Medical Center Department of Anesthesia.Interventions: A survey study was conducted using the Oswestry Disability Index (ODI), a validated scoring system for low back pain. Additional questions related to the daily activities of clinical anesthesia practice were also asked. The survey instrument underwent pretesting and clinical sensibility testing to ensure validity and consistent interpretation.Measurements: The primary self-reported measures were the prevalence of low back pain in anesthesia providers and an assessment of disability based on the ODI. Secondary functional measures included the impact of low back pain on work flow.Main Results: Nearly half (46.6%) of respondents suffer from low back pain attributed to clinical practice. In this subset of respondents, 70.1% reported not having back pain prior to their anesthesia training. Of those with low back pain, 44% alter their work flow, and 9.8% reported missing at least one day of work. Six providers (5.3%) required surgical intervention. Using the ODI score interpretation guidelines, 46% of respondents had a "mild disability" and 2% had a "moderate disability." Respondents reporting feeling "burned out" from their job had a significantly higher average ODI score compared to those who did not (6.8 vs 3.3, respectively; P=.01).Conclusions: Nearly half of all anesthesia providers sampled suffer from low back pain subjectively attributed to their clinical practice. This leads to changes in work flow and missed days of work. The results of this study suggest a deficiency in the effectiveness of anesthesia training programs in teaching proper techniques to prevent musculoskeletal injuries. [ABSTRACT FROM AUTHOR]

The article presents a study which was carried out to compare the sensitivity and specificity of school hearing screening in Pennsylvania with hearing screening designed to detect adolescent hearing loss. The study was carried out in a single public high school in 2011. It concludes that current school hearing screens have low sensitivity for detecting adolescent hearing loss.

Abstract: The concordance correlation coefficient is one of the most common approaches used to assess agreement among different observers or instruments when the outcome of interest is a continuous variable. A SAS macro and R package are provided here to estimate the concordance correlation coefficient (CCC) where the design of the data involves repeated measurements by subject and observer. The CCC is estimated using U-statistics (UST) and variance components (VC) approaches. Confidence intervals and standard errors are reported along with the point estimate of the CCC. In the case of the VC approach, the linear mixed model output and variance components estimates are also provided. The performance of each function is shown by means of some examples with real data sets. [Copyright &y& Elsevier]

Current practices for umbilical cord care vary across centers, but the evidence regarding these practices and their impact on cord separation, complications, and health care use are limited. The objective of this study was to compare the effect of triple dye alone (brilliant green, crystal violet, and proflavine hemisulfate) versus triple dye plus rubbing alcohol (isopropyl alcohol) twice daily on time to umbilical cord separation, complications, and health care use. For the 90 newborns who completed the study, there were no significant differences between treatment groups for time to cord separation, cord-related morbidities, or cord-related urgent care. Based on these study results, there does not appear to be significant benefit to the addition of twice daily applications of rubbing alcohol to neonatal umbilical cords following triple dye treatment after birth. [ABSTRACT FROM AUTHOR]

Background: Although guidelines recommend daily therapy for patients with mild persistent asthma, prescription patterns suggest that most such patients use these so-called controller therapies intermittently. In patients with mild persistent asthma, we evaluated the efficacy of intermittent short-course corticosteroid treatment guided by a symptom-based action plan alone or in addition to daily treatment with either inhaled budesonide or oral zafirlukast over a one-year period. Methods: In a double-blind trial, 225 adults underwent randomization. The primary outcome was morning peak expiratory flow (PEF). Other outcomes included the forced expiratory volume in one second (FEV1) before and after bronchodilator treatment, the frequency of exacerbations, the degree of asthma control, the number of symptom-free days, and the quality of life. Results: The three treatments produced similar increases in morning PEF (7.1 to 8.3 percent; approximately 32 liters per minute; P=0.90) and similar rates of asthma exacerbations (P=0.24), even though the intermittent-treatment group took budesonide, on average, for only 0.5 week of the year. As compared with intermittent therapy or daily zafirlukast therapy, daily budesonide therapy produced greater improvements in pre-bronchodilator FEV1 (P=0.005), bronchial reactivity (P<0.001), the percentage of eosinophils in sputum (P=0.007), exhaled nitric oxide levels (P=0.006), scores for asthma control (P<0.001), and the number of symptom-free days (P=0.03), but not in post-bronchodilator FEV1 (P=0.29) or in the quality of life (P=0.18). Daily zafirlukast therapy did not differ significantly from intermittent treatment in any outcome measured. Conclusions: It may be possible to treat mild persistent asthma with short, intermittent courses of inhaled or oral corticosteroids taken when symptoms worsen. Further studies are required to determine whether this novel approach to treatment should be recommended. N Engl J Med 2005;352:1519-28. [ABSTRACT FROM AUTHOR]

Sphingosine kinase 1 (SphK1) is an oncoprotein capable of directly transforming cells and is associated with resistance to chemotherapy and radiotherapy. SphK1 is increased in various human cancers; whereas, blockade restores sensitivity to therapeutic killing in chemotherapy resistant cancer cell lines. We investigated SphK1 expression in clinical tissue samples from patients with non-Hodgkin lymphomas (NHL). Tissues from 69 patients with either NHL (n = 44) or reactive lymphoid hyperplasias (RH) (n = 25) were examined for expression of SphK1 protein by Western blot and immunohistochemistry (IHC), and SphK1 and SphK2 mRNA by quantitative real-time reverse transcriptase polymerase chain reaction. SphK1 protein (p = 0.008) and mRNA (p = 0.035) levels were higher in NHL than RH, with a clear trend toward increasing levels with increasing clinical grade (p = 0.005 for SphK1 protein, p = 0.035 for IHC score and p = 0.002 for SphK1 mRNA). IHC generally confirmed protein signal in neoplastic cells, but some lymphomas exhibited staining in non-neoplastic cells. SphK1 is overexpressed in NHL and increases with increasing clinical grade. These results, combined with prior mechanistic studies suggest that SphK1 is an attractive novel target for pharmacological interventions for NHL. [ABSTRACT FROM AUTHOR]

Conclusions. The family-directed program was associated with reduced smoking onset for non-Hispanic Whites, suggesting that it is worthy of further application, development, and evaluation. (Am J Public Health. 2001;91: 604-610) [ABSTRACT FROM AUTHOR]

Context: In the mid-1980s, states expanded their initiatives of scholarships, loan repayment programs, and similar incentives to recruit primary care practitioners into underserved areas. With no national coordination or mandate to publicize these efforts, little is known about these state programs and their recent growth.Objectives: To identify and describe state programs that provide financial support to physicians and midlevel practitioners in exchange for a period of service in underserved areas, and to begin to assess the magnitude of the contributions of these programs to the US health care safety net.Design: Cross-sectional, descriptive study of data collected by telephone, mail questionnaires, and through other available documents, (eg, program brochures, Web sites).Setting and Participants: All state programs operating in 1996 that provided financial support in exchange for service in defined underserved areas to student, resident, and practicing physicians; nurse practitioners; physician assistants; and nurse midwives. We excluded local community initiatives and programs that received federal support, including that from the National Health Service Corps.Main Outcome Measures: Number and types of state support-for-service programs in 1996; trends in program types and numbers since 1990; distribution of programs across states; numbers of participating physicians and other practitioners in 1996; numbers in state programs relative to federal programs; and basic features of state programs.Results: In 1996, there were 82 eligible programs operating in 41 states, including 29 loan repayment programs, 29 scholarship programs, 11 loan programs, 8 direct financial incentive programs, and 5 resident support programs. Programs more than doubled in number between 1990 (n = 39) and 1996 (n = 82). In 1996, an estimated 1306 physicians and 370 midlevel practitioners were serving obligations to these state programs, a number comparable with those in federal programs. Common features of state programs were a mission to influence the distribution of the health care workforce within their states' borders, an emphasis on primary care, and reliance on annual state appropriations and other public funding mechanisms.Conclusions: In 1996, states fielded an obligated primary care workforce comparable in size to the better-known federal programs. These state programs constitute a major portion of the US health care safety net, and their activities should be monitored, coordinated, and evaluated. State programs should not be omitted from listings of safety-net initiatives or overlooked in future plans to further improve health care access. JAMA. 2000;284:2084-2092. [ABSTRACT FROM AUTHOR]

Eight expert orthopedic pathologists voluntarily reviewed the clinicoradiologic and histologic data from 12 selected cases coded as osteosarcoma over the past seven years (procured from a total of 40 cases) from the files of the University of North Carolina and Wake Forest University. The study sample was chosen to include a full spectrum of histologic grades and subtypes including conventional, low-grade central, chondroblastoma-like, osteoblastoma-like, small cell, telangiectatic, parosteal, and periosteal variants. Participants were asked to render a diagnosis, provide a histologic grade (if applicable), and offer an opinion as to whether the patient could benefit from chemotherapy. Uniform agreement regarding the diagnosis of osteosarcoma was observed in 7 cases (58 hr %), including the most common, conventional subtypes, and the telangiectatic, parosteal, and periosteal variants. Among the remaining 5 cases, the consensus majority (≥ 4) also was osteosarcoma. However, additional diagnoses ranged from osteoblastoma to high-grade osteosarcoma in two tumors, mesenchymal chondrosarcoma versus small cell osteosarcoma in one, fibrosarcoma and malignant fibrous histiocytoma versus fibroblastic osteosarcoma in another, and clear cell chondrosarcoma versus chondroblastoma versus chondroblastic osteosarcoma in a fifth. Among osteosarcoma diagnoses, histologic grading ranged from low- to high-grade osteosarcoma in 6 tumors (50 %). Regarding the necessity for chemotherapy, there was disagreement from at least one consultant in 7 cases (58 hr %). Evaluation of the intraclass correlation coefficient revealed modest agreement with respect to histologic grade and therapy but poor agreement for diagnosis, the latter reflecting the wide range of diagnoses in a minority of cases. Interobserver variability exists among expert orthopedic pathologists for determining the diagnosis, histologic grade, and necessity of chemotherapy in less common forms of osteosarcoma. A more objective histologic grading and scoring system for osteosarcoma should be established, followed by multi-institutional studies assessing the usefulness of the system as it relates to the necessity of chemotherapy and survival. [ABSTRACT FROM AUTHOR]

The risk of expansile hematoma and airway compromise following neck surgery have been used to validate overnight observation. We investigated the outcomes of pediatric patients undergoing a Sistrunk procedure via either same day surgery or overnight observation. A retrospective review of patients undergoing Sistrunk procedures between January 1, 2008 to January 1, 2019 was performed. 76 cases were identified for review. Bivariate and multivariable analyses were performed to determine predictive factors for overnight admission as well as associations between overnight observation and adverse outcomes (hematoma, seroma, airway compromise, infection). Factors evaluated for analysis included ASA class, surgeon type, history of pre-operative infection, recurrent case, operation >90 min, pharyngeal violation, intraoperative cyst rupture, cyst size, and drain placement. No patients had life-threatening adverse events. There was no difference in complication rates between same day discharge (17%) and overnight observation (23%, p = 0.47). Otolaryngologists were more likely to admit patients overnight (88% vs. 14%, p = 0.042) as well as place a drain (97% vs. 24%, p < 0.001) when compared to pediatric surgeons. Drain placement was associated with overnight observation (73% vs. 3%, p < 0.001). Multivariable logistic regression demonstrated drain placement (OR 21.9, 95%CI (2.5–189.7), p = 0.005) and otolaryngologist as operative surgeon (OR 11.7, 95%CI (2.8–48.2), p < 0.001) as strong predictive variables for overnight observation. There was no association between other investigated variables and adverse events or overnight stay. Same day Sistrunk operations are safe in select healthy patients. Overnight observation appears to be driven by drain placement and surgeon practice patterns. [ABSTRACT FROM AUTHOR]

Sleep disturbance is common postoperatively. We examined whether melatonin concentrations were related to this disturbance in seven postoperative patients. Nocturnal concentrations of melatonin were significantly (p=0.005) lower on the first than on the second or third nights after surgery. This finding raises the possibility that melatonin suppression and associated sleep disturbance might be prevented by melatonin replacement. [ABSTRACT FROM AUTHOR]