Actigraphy measures show sleep improvement after parathyroidectomy for primary hyperparathyroidism.

IMPORTANCE: The symptoms of primary hyperparathyroidism are often subtle, such as fatigue, mood changes, and sleep disturbances. After parathyroidectomy, patients often report improvement in sleep and mood; however, objective data supporting these improvements is lacking. OBJECTIVE: This prospective study uses standard measures to objectively and subjectively assess sleep in patients with primary hyperparathyroidism before and after parathyroidectomy. DESIGN: A longitudinal prospective study was conducted over three one-week-long periods: pre-parathyroidectomy, 1-week post-parathyroidectomy, and three months post-parathyroidectomy. During each time point, patients wore an actigraphy device, recorded a sleep diary, and completed the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), and Depression Anxiety Stress Scale (DASS). Statistical analysis was performed using repeated measures models to compare the average measures among the three time points and test for trends over time. SETTING: Single institution, tertiary care center. PARTICIPANTS: Patients with primary hyperparathyroidism from ages 18 to 89 years old. EXPOSURE: Parathyroidectomy between September 2020 and January 2024. MAIN OUTCOMES AND MEASURES: Actigraphy data, consensus sleep diary, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Depression Anxiety Stress Scales - 21 Items (DASS). RESULTS: Thirty-six patients were enrolled, and 34 patients completed the study. Actigraphy data showed a significant negative trend in average sleep latency (p = 0.045) and average time in bed (p = 0.046). Sleep diary data showed additional differences in the number of awakenings (p = 0.002), wake after sleep onset (p < 0.001), sleep quality (p < 0.001), and sleep efficiency (p = 0.02) among the three time points and/or as a significant negative trend. PSQI and ISI scores were significantly different among the three time points (p = 0.002 and p < 0.001, respectively) and also declined significantly over time (p = 0.008 and p = 0.007, respectively). DASS depression, anxiety, and stress scores were significantly different among the three time points (p < 0.001, p = 0.01, and p < 0.001, respectively), and stress also declined significantly over time (p = 0.005). CONCLUSION AND RELEVANCE: This study represents the most extensive prospective study demonstrating objective and subjective sleep and mood improvement in patients with primary hyperparathyroidism after parathyroidectomy.

Limited Efficacy of Empiric Antibiotics for Pediatric Facial Fractures.

BACKGROUND: Controversies exist regarding the role of perioperative antibiotic use in pediatric craniomaxillofacial fracture repair. PURPOSE: This study aims to identify factors associated with antibiotic prescribing patterns and measures the association between antibiotic exposure and postoperative infections. STUDY DESIGN, SETTING, SAMPLE: In this retrospective cohort study, TriNetX, a research database, was used to gather data on patients under 18 years of age who underwent repair of facial fractures. The records were obtained from 2003 to 2021. Current Procedural Terminology codes for facial fracture procedures were used to identify patients. PREDICTOR/EXPOSURE/INDEPENDENT VARIABLE: Antibiotic use, defined as a binary categorical variable of whether or not patients received perioperative antibiotics. The secondary predictor variable was timing of antibiotic administration, categorized by pre, intra, and postoperative administration. MAIN OUTCOME VARIABLES: Postoperative infection, determined by International Classification of Diseases, 9th and 10th Revision codes within patient charts. COVARIATES: Covariates included demographic variables such as age, sex, race, ethnicity, geographic location, and fracture characteristics, such as number of fractures and location of fracture. ANALYSES: χ2 analyses were used for categorical variables and two sample t tests for quantitative variables. Multivariable logistic regression was used to evaluate patient infection and antibiotic use with adjustment for covariates. P-values were 2-tailed and statistical significance was defined as P < .05. RESULTS: This cohort included 5,413 patients of which 70.4% were male, 74.4% identified as white, and 83.3% identified as non-Hispanic or Latino. There were no differences in postoperative infections in patients who received antibiotics compared to those who did not (0.9 vs 0.5%, respectively, P = .12). Nevertheless, antibiotic prescriptions have increased over the years. After controlling for relevant covariates, antibiotic use did not decrease the odds of infection (adjusted odds ratio 1.1, 95% CI 0.53 to 2.34, P = .79). There was a significant association between the timing of antibiotic use and infection (P = .044), with increased odds of infection when antibiotics were given postoperatively (adjusted odds ratio 3.8, 95% CI 1.2 to 12.07, P = .023). CONCLUSION AND RELEVANCE: While antibiotic prescriptions have increased over the years, this study demonstrates there is no difference in postoperative infection rates for pediatric patients prescribed antibiotics and those where were not.

Mometasone or Tiotropium in Mild Asthma with a Low Sputum Eosinophil Level.

BACKGROUND: In many patients with mild, persistent asthma, the percentage of eosinophils in sputum is less than 2% (low eosinophil level). The appropriate treatment for these patients is unknown. METHODS: In this 42-week, double-blind, crossover trial, we assigned 295 patients who were at least 12 years of age and who had mild, persistent asthma to receive mometasone (an inhaled glucocorticoid), tiotropium (a long-acting muscarinic antagonist), or placebo. The patients were categorized according to the sputum eosinophil level (<2% or ≥2%). The primary outcome was the response to mometasone as compared with placebo and to tiotropium as compared with placebo among patients with a low sputum eosinophil level who had a prespecified differential response to one of the trial agents. The response was determined according to a hierarchical composite outcome that incorporated treatment failure, asthma control days, and the forced expiratory volume in 1 second; a two-sided P value of less than 0.025 denoted statistical significance. A secondary outcome was a comparison of results in patients with a high sputum eosinophil level and those with a low level. RESULTS: A total of 73% of the patients had a low eosinophil level; of these patients, 59% had a differential response to a trial agent. However, there was no significant difference in the response to mometasone or tiotropium, as compared with placebo. Among the patients with a low eosinophil level who had a differential treatment response, 57% (95% confidence interval [CI], 48 to 66) had a better response to mometasone, and 43% (95% CI, 34 to 52) had a better response to placebo (P = 0.14). In contrast 60% (95% CI, 51 to 68) had a better response to tiotropium, whereas 40% (95% CI, 32 to 49) had a better response to placebo (P = 0.029). Among patients with a high eosinophil level, the response to mometasone was significantly better than the response to placebo (74% vs. 26%) but the response to tiotropium was not (57% vs. 43%). CONCLUSIONS: The majority of patients with mild, persistent asthma had a low sputum eosinophil level and had no significant difference in their response to either mometasone or tiotropium as compared with placebo. These data provide equipoise for a clinically directive trial to compare an inhaled glucocorticoid with other treatments in patients with a low eosinophil level. (Funded by the National Heart, Lung, and Blood Institute; SIENA ClinicalTrials.gov number, NCT02066298.).

The posterior tibial slope and Insall-Salvati index in operative and nonoperative adolescent athletes with Osgood-Schlatter disease.

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.

T3 versus T4a staging challenges in deeply invasive colonic adenocarcinomas and correlation with clinical outcomes.

Despite the latest 8th edition American Joint Committee on Cancer Staging Manual guidelines, disagreement still exists among pathologists regarding staging deeply invasive colonic adenocarcinomas ≤1 mm to the serosal surface. In this retrospective study, 151 untreated colonic adenocarcinomas staged initially as either pT3 or pT4a and with available 5-year follow-up data were retrieved and re-categorized: Group 1 (38 cases): pT4a with tumor at the serosa; Group 2 (49 cases): tumor ≤1 mm from the serosa, with intervening reactive fibrosis (40/49) or inflammation (9/49); Group 3 (64 cases): pT3 tumor >1 mm from the serosa. Clinical outcomes were analyzed. Groups 1 and 2 tumors showed significantly lower 5-year recurrence-free survival and lower overall survival rates (log-rank p < 0.001 for both), when compared with Group 3 tumors. Even after adjusting for adjuvant therapy and nodal metastases, the proportional hazards ratios for the risk of death (p < 0.001) and risk of recurrence (p = 0.005) showed significantly higher risk in Groups 1 and 2 compared with Group 3. The synchronous nodal (p = 0.012) and metachronous distant metastases (p = 0.004) were also significantly more in Groups 1 and 2 versus Group 3. Colonic adenocarcinomas ≤1 mm from the serosal surface behaved more akin to "bona fide" pT4a tumors at the serosal surface in our study with regards to clinical outcomes. We recommend these tumors be staged as pT4a rather than pT3, as supported by outcome data in our study. We hope this will also ensure reproducibility and consistency in staging these tumors across institutions.

Challenges with colorectal cancer staging: results of an international study.

Challenges exist with standardized colorectal cancer reporting despite adoption of the American Joint Committee on Cancer-Staging Manual 8th edition. We performed this study to gauge current practice patterns among a diverse group of surgical pathologists. A web-based questionnaire depicting problematic issues and images related to colorectal carcinoma staging was circulated among 118 surgical pathologists and their responses were correlated with their geographic location (North America vs. Europe vs. others), nature of practice (academic vs. community), the sign-out model (gastrointestinal subspecialty vs. general surgical pathology), and years of professional experience. We found that a substantial number of practicing pathologists ignore recommended-staging criteria in specific settings, particularly with respect to assessment of advanced T stage. Tumors that communicated with the serosa through inflammatory foci were staged as pT3 (49%) or pT4a (51%) by nearly equal numbers of pathologists regardless of level of experience, the sign-out model, or geographic location. Only 65% assigned T stage and margin status based on extent of viable tumor in the neoadjuvant setting. One-third of pathologists, particularly those in Europe (p = 0.015), classified acellular mucin deposits as N1 disease when detected in treatment-naive cases. Nearly 50% of pathologists classified isolated tumor cells (i.e., deposits <0.2 mm) in lymph nodes as metastatic disease (i.e., pN1, p = 0.02). Our results suggest that pathologists ignore recommendations that are based on insufficient data and apply individualized criteria when faced with situations that are not addressed in the American Joint Committee on Cancer Staging Manual 8th edition. These variations in practice limit the ability to compare outcome data across different institutions and draw attention to areas that require further study.

CHA2DS2-VASc Score and In-Hospital Mortality in Critically Ill Patients With New-Onset Atrial Fibrillation.

OBJECTIVE: To examine the role of the CHA2DS2-VASc (Congestive heart failure; Hypertension; Age ≥75 years [doubled]; Diabetes; previous Stroke, transient ischemic attack, or thromboembolism [doubled]; Vascular disease; Age 65-75 years; and Sex category) score as a prognostic marker of in-hospital mortality in critically ill patients who develop new-onset atrial fibrillation (NOAF). DESIGN: Retrospective analyses. SETTING: A single-center study in a tertiary care academic medical center. PARTICIPANTS: The study comprised all adult patients with NOAF admitted to noncardiac intensive care units (ICUs) at a tertiary care academic institution between January 2009 and March 2016. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The authors retrospectively reviewed electronic medical records of all adult patients admitted to noncardiac ICUs at a tertiary care academic institution between January 2009 and March 2016. Patients with NOAF were identified and their CHA2DS2-VASc score was calculated. The authors evaluated the association of CHA2DS2-VASc score and its individual components with in-hospital mortality in these patients. A total of 640 (1.7% [38,708 patients]; 95% CI 1.5%-1.8%) patients developed NOAF during the study period. The in-hospital mortality rate in patients included in the analysis was 14.3%. There was no association between in-hospital mortality and CHA2DS2VASc score. However, the likelihood of in-hospital death was 1.56  times greater for patients having atrial fibrillation and concomitant vascular disease (95% CI 1.003-2.429; p = 0.049). CONCLUSIONS: New-onset atrial fibrillation is common in critically ill patients and is associated with high in-hospital mortality. The authors found that the CHA2DS2-VASc score itself is not a reliable prognostic marker of in-hospital mortality in these patients. However, the presence of vascular disease in patients with NOAF may increase the mortality associated with this disease.

A Comparison of Transesophageal to Transthoracic Echocardiographic Measures of Right Ventricular Function.

OBJECTIVES: To assess the concordance between transesophageal echocardiographic (TEE) and transthoracic echocardiograpic (TTE) measures of right ventricular (RV) function using standard 2-dimensional and Doppler methods. The authors hypothesized that there would be significant disagreement in tricuspid annular plane systolic excursion (TAPSE), fractional area change, right-sided index of myocardial performance, and tricuspid annular systolic velocity (S'). DESIGN: Prospective observational. SETTING: Cardiac operating room at a single academic medical center. PARTICIPANTS: All adult patients undergoing elective cardiac surgery at a single tertiary care academic medical center over 6 months. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The fractional area change, S', TAPSE, right-sided index of myocardial performance, and tricuspid annular diameter were measured with TEE and TTE to assess for concordance using the concordance correlation coefficient and paired t tests, including 95% confidence limits. The study demonstrated that quantitative measures of RV function by TEE correlate poorly with TTE measurements in close temporal proximity under similar hemodynamic conditions. CONCLUSIONS: When performing an assessment of RV function, transesophageal echocardiographers should exercise caution when extrapolating data validated by TTE to TEE studies. Measures of RV function by TEE tend to have fair agreement to TTE measurements obtained in close temporal proximity under similar hemodynamic conditions. Most importantly, the present study showed that TAPSE and S' values obtained from the modified transgastric RV inflow view tend to have lower values than those measured with TTE. Given the propensity for underestimating measurements from the modified transgastric RV inflow view, the authors conclude that values equal to or greater than established norms for tricuspid annular motion may be used to establish normal-but not abnormal-RV function.

Exacerbation-prone asthma in the context of race and ancestry in Asthma Clinical Research Network trials.

BACKGROUND: Minority groups of African descent experience disproportionately greater asthma morbidity compared with other racial groups, suggesting that genetic variation from a common ancestry could influence exacerbation risk. OBJECTIVE: We evaluated clinical trial measures in the context of self-reported race and genetic ancestry to identify risk factors for asthma exacerbations. METHODS: One thousand eight hundred forty multiethnic subjects from 12 Asthma Clinical Research Network and AsthmaNet trials were analyzed for incident asthma exacerbations with Poisson regression models that included clinical measures, self-reported race (black, non-Hispanic white, and other), and estimates of global genetic African ancestry in a subgroup (n = 760). RESULTS: Twenty-four percent of 1840 subjects self-identified as black. Black and white subjects had common risk factors for exacerbations, including a history of 2 or more exacerbations in the previous year and FEV1 percent predicted values, whereas chronic sinusitis, allergic rhinitis, and gastroesophageal reflux disease were only associated with increased exacerbation risk in black subjects. In the combined multiethnic cohort, neither race (P = .30) nor percentage of genetic African ancestry as a continuous variable associated with exacerbation risk (adjusted rate ratio [RR], 1.26 [95% CI, 0.94-1.70; P = .13]; RR per 1-SD change [32% ancestry], 0.97 [95% CI, 0.78-1.19; P = .74]). However, in 161 black subjects with genetic data, those with African ancestry greater than the median (≥82%) had a significantly greater risk of exacerbation (RR, 3.06 [95% CI, 1.09-8.6; P = .03]). CONCLUSION: Black subjects have unique risk factors for asthma exacerbations, of which global African genetic ancestry had the strongest effect.

A Tailored Intervention for PAP Adherence: The SCIP-PA Trial.

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.

Income is an independent risk factor for worse asthma outcomes.

BACKGROUND: Socioeconomic status (SES) is associated with asthma morbidity in observational studies, but the factors underlying this association are uncertain. OBJECTIVE: We investigated whether 3 SES correlates-low income, low education, and high perceived stress-were independent risk factors for treatment failure and asthma exacerbations in the context of a randomized controlled trial. METHODS: The effect of low SES (household income of <$50,000/y and household educational level of less than a Bachelor's degree) and high perceived stress (defined as a score of >20 on a perceived stress scale) on asthma morbidity was analyzed in 381 participants by using Poisson regression models. The primary outcome was treatment failure (defined in the trial protocol as a significant clinical or airflow deterioration), and the secondary outcome was asthma exacerbations requiring systemic corticosteroids. RESULTS: Fifty-four percent of participants had a low income, 40% had a low educational level, and 17% had high perceived stress levels. Even after adjusting for race and other important confounders, participants with lower income had higher rates of both treatment failures (rate ratio, 1.6; 95% CI, 1.1-2.3; P = .03) and exacerbations (rate ratio, 1.9; 95% CI, 1.1-3.3; P = .02). Adherence with inhaled corticosteroids was similarly high for both income categories. Education and perceived stress were not significantly associated with either outcome. CONCLUSIONS: In the context of a randomized controlled trial, participants with lower income were more likely to experience adverse asthma outcomes independent of education, perceived stress, race, and medication adherence.

Obesity's effect on asthma extends to diagnostic criteria.

BACKGROUND: The use of inflammatory biomarkers to delineate the type of lung inflammation present in asthmatic subjects is increasingly common. However, the effect of obesity on these markers is unknown. OBJECTIVES: We aimed to determine the effect of obesity on conventional markers of inflammation in asthmatic subjects. METHODS: We performed secondary analysis of data from 652 subjects previously enrolled in 2 Asthma Clinical Research Network trials. We performed linear correlations between biomarkers and logistic regression analysis to determine the predictive value of IgE levels, blood eosinophil counts, and fraction of exhaled nitric oxide values in relationship to sputum eosinophil counts (>2%), as well as to determine whether cut points existed that would maximize the sensitivity and specificity for predicting sputum eosinophilia in the 3 weight groups. RESULTS: Overall, statistically significant but relatively weak correlations were observed among all 4 markers of inflammation. Within obese subjects, the only significant correlation found was between IgE levels and blood eosinophil counts (r = 0.33, P < .001); furthermore, all other correlations between inflammatory markers were approximately 0, including correlations with sputum eosinophil counts. In addition, the predictive value of each biomarker alone or in combination was poor in obese subjects. In fact, in obese subjects none of the biomarkers of inflammation significantly predicted the presence of high sputum eosinophil counts. Obese asthmatic subjects have lower cut points for IgE levels (268 IU), fraction of exhaled nitric oxide values (14.5 ppb), and blood eosinophil counts (96 cells/µL) than all other groups. CONCLUSIONS: In obese asthmatic subjects conventional biomarkers of inflammation are poorly predictive of eosinophilic airway inflammation. As such, biomarkers currently used to delineate eosinophilic inflammation in asthmatic subjects should be approached with caution in these subjects.

Association of free vitamin D3 concentrations and asthma treatment failures in the VIDA Trial.

BACKGROUND: Use of vitamin D3 serum concentrations as a biomarker of vitamin D status is questionable because of variation in vitamin D binding protein. OBJECTIVE: To determine associations between free vitamin D3 concentrations and rates of treatment failure and exacerbations in patients with asthma participating in the Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma (VIDA) trial. METHODS: Free concentrations were directly measured by enzyme-linked immunosorbent assay and stratified into low, medium, and high groups: less than 5pg/mL (n = 65), 5 to 9pg/mL (n = 84), and greater than 9pg/mL (n = 48) after 12 weeks of supplementation with oral vitamin D3 and associated with outcomes. RESULTS: Outcomes did not associate with free concentrations: overall treatment failure rates were 0.60 (95% confidence interval [CI] 0.46-0.78), 0.53 (95%CI 0.40- 0.70), and 0.69 (95%CI 0.54-0.90)/person-year (P = .51), respectively; overall exacerbation rates were 0.28 (95%CI 0.17-0.48), 0.15 (95%CI 0.08-0.30) and 0.42 (95%CI 0.27-0.66)/person-year (P = .22). Mean (standard deviation) baseline free concentrations were lower in non-Hispanic blacks and Hispanics compared with non-Hispanic whites: 4.10 (1.33) and 4.38 (1.11) pg/mL vs 5.16 (1.65) pg/ml, (P < .001 and P = 0.038), respectively. Mean (standard deviation) baseline free concentrations differed between females and males: 4.57 (1.58) and 5.08 (1.41) (P = .026); and between non-overweight (body mass index [BMI] < 25) and overweight (BMI > 25): 5.45 (1.86) vs 4.54 (1.39) (P < .001). The free fraction differed by race and sex but not by BMI. CONCLUSION: The use of free concentrations was inferior to total concentrations as a biomarker of efficacy of vitamin D3 supplementation in VIDA trial participants. Future studies of vitamin D status in patients with asthma should measure both free and total concentrations to better understand which marker of vitamin D function is most informative.

Vitamin D Supplementation and the Risk of Colds in Patients with Asthma.

RATIONALE: Restoration of vitamin D sufficiency may reduce asthma exacerbations, events that are often associated with respiratory tract infections and cold symptoms. OBJECTIVES: To determine whether vitamin D supplementation reduces cold symptom occurrence and severity in adults with mild to moderate asthma and vitamin D insufficiency. METHODS: Colds were assessed in the AsthmaNet VIDA (Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness) trial, in which 408 adult patients were randomized to receive placebo or cholecalciferol (100,000 IU load plus 4,000 IU/d) for 28 weeks as add-on therapy. The primary outcome was cold symptom severity, which was assessed using daily scores on the 21-item Wisconsin Upper Respiratory Symptom Survey. MEASUREMENTS AND MAIN RESULTS: A total of 203 participants experienced at least one cold. Despite achieving 25-hydroxyvitamin D levels of 41.9 ng/ml (95% confidence interval [CI], 40.1-43.7 ng/ml) by 12 weeks, vitamin D supplementation had no effect on the primary outcome: the average peak WURSS-21 scores (62.0 [95% CI, 55.1-68.9; placebo] and 58.7 [95% CI, 52.4-65.0; vitamin D]; P = 0.39). The rate of colds did not differ between groups (rate ratio [RR], 1.2; 95% CI, 0.9-1.5); however, among African Americans, those receiving vitamin D versus placebo had an increased rate of colds (RR, 1.7; 95% CI, 1.1-2.7; P = 0.02). This was also observed in a responder analysis of all subjects achieving vitamin D sufficiency, regardless of treatment assignment (RR, 1.4; 95% CI, 1.1-1.7; P = 0.009). CONCLUSIONS: Our findings in patients with mild to moderate asthma undergoing an inhaled corticosteroid dose reduction do not support the use of vitamin D supplementation for the purpose of reducing cold severity or frequency.

The Sensitivity of Adolescent School-Based Hearing Screens Is Significantly Improved by Adding High Frequencies.

High frequency hearing loss (HFHL), often related to hazardous noise, affects one in six U.S. adolescents. Yet, only 20 states include school-based hearing screens for adolescents. Only six states test multiple high frequencies. Study objectives were to (1) compare the sensitivity of state school-based hearing screens for adolescents to gold standard sound-treated booth testing and (2) consider the effect of adding multiple high frequencies and two-step screening on sensitivity/specificity. Of 134 eleventh-grade participants (2013-2014), 43 of the 134 (32%) did not pass sound-treated booth testing, and 27 of the 43 (63%) had HFHL. Sensitivity/specificity of the most common protocol (1,000, 2,000, 4,000 Hz at 20 dB HL) for these hearing losses was 25.6% (95% confidence interval [CI] = [13.5, 41.2]) and 85.7% (95% CI [76.8, 92.2]), respectively. A protocol including 500, 1,000, 2,000, 4,000, 6,000 Hz at 20 dB HL significantly improved sensitivity to 76.7% (95% CI [61.4, 88.2]), p < .001. Two-step screening maintained specificity (84.6%, 95% CI [75.5, 91.3]). Adolescent school-based hearing screen sensitivity improves with high frequencies.

Risk assessment for CPAP nonadherence in adults with newly diagnosed obstructive sleep apnea: preliminary testing of the Index for Nonadherence to PAP (I-NAP).

PURPOSE: Identification of risk for continuous positive airway pressure therapy (CPAP) nonadherence prior to home treatment is an opportunity to deliver targeted adherence interventions. Study objectives included the following: (1) test a risk screening questionnaire to prospectively identify CPAP nonadherence risk among adults with newly diagnosed obstructive sleep apnea (OSA), (2) reduce the questionnaire to a minimum item set that effectively identifies 1-month CPAP nonadherence, and (3) examine the diagnostic utility of the screening index. METHODS: A prospective, longitudinal study at two clinical sleep centers in the USA included adults with newly diagnosed OSA (n=97; AHI≥5 events/h) by polysomnogram (PSG) consecutively recruited to participate. After baseline participant and OSA characteristics were collected, a risk screening questionnaire was administered immediately following CPAP titration polysomnogram. One-month objective CPAP use was collected. RESULTS: Predominantly, white (87%), males (55%), and females (45%) with obesity (BMI 38.3 kg/m2; SD 9.3) and severe OSA (AHI 36.8; SD 19.7) were included. One-month CPAP use was 4.25 h/night (SD 2.35). Nineteen questionnaire items (I-NAP) reliably identified nonadherers defined at <4 h/night CPAP use (Wald X2[8]=34.67, p<0.0001) with ROC AUC 0.83 (95% CI 0.74-0.91). Optimal score cut point for the I-NAP screening questionnaire were determined to maximize sensitivity (87%) while maintaining specificity>60% (63%). CONCLUSION: A risk screening questionnaire employed immediately after titration PSG may reliably identify CPAP nonadherers and permit the delivery of targeted interventions to prevent or reduce nonadherence. This novel approach may enhance cost-effectiveness of care and permit appropriate allocation of resources for CPAP adherence.

Is inconsistent pre-treatment bedtime related to CPAP non-adherence?

Lack of adherence to continuous positive airway pressure therapy (CPAP) limits the effectiveness of treatment of obstructive sleep apnea (OSA). We hypothesized that an irregular bedtime would be negatively related to regular use of CPAP treatment. If so, modifying bedtime schedule may address the persistent problem of inconsistent CPAP use in adults with OSA. In a prospective longitudinal study, we examined whether inconsistent self-reported bedtime before initiation of CPAP treatment, operationalized as bedtime variability, was (1) different among those adherent (≥4 hours per night) and non-adherent to CPAP treatment at 1 week and 1 month; and/or (2) was related to 1-week and 1-month CPAP use when other variables were accounted for. Consecutively recruited newly diagnosed OSA adults (n = 79) completed sleep diaries prior to CPAP treatment. One-week and 1-month objective CPAP use data were collected. Pre-treatment bedtime variability was different among CPAP non-adherers and adherers at 1 month and was a significant predictor of non-adherence at 1 month in multi-variable analyses. The odds of 1-month CPAP non-adherence were 3.5 times greater in those whose pre-treatment bedtimes varied by >75 minutes. Addressing sleep schedule prior to CPAP initiation may be an opportunity to improve CPAP adherence.

Do oral corticosteroids reduce the severity of acute lower respiratory tract illnesses in preschool children with recurrent wheezing?

BACKGROUND: Oral corticosteroids (OCSs) are recommended for severe wheezing episodes in children. However, limited evidence supports this intervention in preschool children with outpatient wheezing illnesses. OBJECTIVE: We sought to investigate whether OCSs reduce symptom scores during acute lower respiratory tract illnesses (LRTIs) in preschool children with recurrent wheeze. METHODS: We performed post hoc and replication analyses in 2 outpatient cohorts of children aged 1 to 5 years with episodic wheezing participating in clinical trials. We compared symptom scores during LRTIs that were or were not treated with OCSs, adjusting for differences in disease and episode severity covariates. We stratified episodes by severity by using a propensity model. The primary outcome was the area under the curve (AUC) of total symptom scores among the more severe episodes. RESULTS: Two hundred fifteen participants from the Acute Intervention Management Strategies trial experienced 798 acute LRTIs, 112 of which were defined as severe based on propensity scores. The AUCs of total symptom scores did not differ between the episodes that were (n = 70) and were not (n = 42) treated with OCSs (P = .46) nor was there an OCS treatment effect on individual symptom scores. Similar analyses of the Maintenance Versus Intermittent Inhaled Corticosteroids in Wheezing Toddlers trial, involving 278 participants with 133 severe LRTIs, confirmed the above findings (P = .46 for AUC of total symptoms score comparison). CONCLUSION: In 2 separate cohorts of preschool children with episodic wheezing, OCS treatment during clinically significant LRTIs did not reduce symptom severity during acute LRTIs, despite asthma controller medication use during most episodes. These findings need to be confirmed in a prospective randomized controlled trial.

Effect of vitamin D3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin D levels: the VIDA randomized clinical trial.

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 ß-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.

Factors Associated With Inadequate Health Literacy: An Academic Otolaryngology Clinic Population Study.

Objective: To characterize the prevalence of inadequate health literacy among otolaryngology patients and assess the association of individual patient factors with inadequate health literacy. Study Design: Cross-sectional study. Setting: Tertiary academic medical center otolaryngology clinic. Methods: Adult patients presenting to the clinic were recruited from March to June 2022. Participants completed a validated health literacy questionnaire in the waiting room. Data on age, sex, race, insurance, county of residence, and language were extracted from the electronic medical record, linked to the survey responses, and deidentified for analysis. Logistic regression analyses assessed the association between inadequate health literacy and patient factors. Results: Of 374 participants, the mean age was 54.8 years (SD = 17.8) and most were white (79%) and native English speakers (95%). The median health literacy score was 14.5 (Q1-Q3: 12.0-15.0) and 43 participants (12%) had inadequate health literacy. Bivariate analysis showed the odds of inadequate health literacy were 2.5 times greater for those with public insurance (95% confidence interval [CI]: 1.24-5.20, P = .011), 3.5 times greater for males (95% CI: 1.75-6.92, P < .001), and significantly different among race groups (P = .003). When all factors were evaluated simultaneously with multivariable regression, only sex (P < .001) and race (P = .005) remained significant predictors of inadequate health literacy. There were no significant associations between health literacy and age or rurality. Conclusion: Inadequate health literacy was associated with sex and race, but not with age or rurality. 12% of patients had inadequate health literacy, which may perpetuate disparities in care and necessitate interventions to improve care delivery in otolaryngology.