Effect of a Comprehensive School-Based Health Center on Academic Growth in K-8th Grade Students.

OBJECTIVE: School-based health centers (SBHCs) improve health care access, but associations with educational outcomes are mixed and limited for elementary and middle school students. We investigated whether students enrolled in a comprehensive SBHC demonstrated more growth in standardized math and reading assessments over 4 school years versus nonenrolled students. We also explored changes in absenteeism. METHODS: Participants were students enrolled in 2 co-located Title I schools from 2015-19 (1 elementary, 1 middle, n = 2480). Analysis of math and reading was limited to students with baseline and postbaseline scores (math n = 1622; reading n = 1607). Longitudinal regression models accounting for within-subject clustering were used to estimate the association of SBHC enrollment with academic scores and daily absenteeism, adjusting for grade, sex, body mass index category, health conditions, baseline outcomes (scores or absenteeism), and outcome pretrends. RESULTS: More than 70% of SBHC-enrolled students had math (1194 [73.6%]) and reading 1186 [73.8%]) scores. Enrollees were more likely than nonenrollees to have asthma (39.7% vs 19.6%) and overweight/obesity (42.4% vs 33.6%). Adjusted baseline scores were significantly lower in math and reading for enrollees. Mean change from baseline for enrollees exceeded nonenrollees by 3.5 points (95% confidence interval [CI]: 2.2, 4.8) in math and 2.1 points (95% CI: 0.9, 3.3) in reading. The adjusted rate of decrease in daily absenteeism was 10.8% greater for enrollees (incident rate ratio 0.772 [95% CI: 0.623, 0.956]) than nonenrollees (incident rate ratio 0.865 [95% CI: 0.696, 1.076]). CONCLUSIONS: SBHC enrollees had greater health and educational risk but demonstrated more growth in math and reading and less absenteeism than nonenrollees.

QDOT MICRO™ versus THERMOCOOL® SMARTTOUCH™ and THERMOCOOL SMARTTOUCH® Surround Flow in radiofrequency ablation of paroxysmal atrial fibrillation.

Aim: The objective of this study was to indirectly compare QDOT MICRO™ (QDOT), Thermocool® SmartTouch™ (ST) and Thermocool® SmartTouch® Surround Flow (STSF) to treat paroxysmal atrial fibrillation. Methods: Differences in baseline characteristics between study cohorts were reduced by reweighting patients using inverse probability of treatment weighting. The primary outcome was procedure time. Secondary outcomes were fluoroscopy time, clinical success at 12 months, and rhythm monitoring-adjusted recurrence. Results: QDOT was associated with significantly faster mean procedure and fluoroscopy time, and significant improvement in the rate of recurrence compared with pooled ST/STSF. No difference was observed for clinical success at 12 months. Conclusion: QDOT was associated with greater efficiency, greater effectiveness in rhythm monitoring-adjusted recurrence and similar effectiveness in clinical success at 12 months compared with pooled ST/STSF.

The burden of red blood cell transfusions in patients with lower-risk myelodysplastic syndromes and ring sideroblasts: an analysis of the prospective MDS-CAN registry.

Many patients with lower-risk myelodysplastic syndromes (LR MDS) require long-term red blood cell (RBC) transfusions to manage anemia. The consequences of RBC transfusions in LR MDS with ring sideroblasts (LR MDS-RS) are not well known. We estimated the association between cumulative RBC dose density and clinical and patient-reported outcomes using data from the MDS-CAN registry for patients enrolled between January 2008 and December 2018. Outcomes included overall survival, hospitalization, and health-related quality of life (HRQoL). A total of 145 enrolled patients with LR MDS and RS ≥5% had a median follow-up time of 27.1 months; 45 had no transfusions during follow-up, 51 had <1 transfusion per month, and 49 had ≥1 transfusion per month. The cumulative density of RBC transfusions was associated with significantly greater mortality, hospitalization, and inferior HRQoL, suggesting that exposure to RBC transfusion may constitute a significant treatment burden in patients with LR MDS-RS.

A natural history of lower-risk myelodysplastic syndromes with ring sideroblasts: an analysis of the MDS-CAN registry.

Patients with lower-risk (LR) myelodysplastic syndromes (MDS) with ring sideroblasts (RS) have better prognosis than those without RS, but how they fare over time is not fully understood. This study's objective was to assess the natural history of LR MDS with RS ≥5% using MDS-CAN registry individual data. Kaplan-Meier estimates and generalized linear mixed models were used to describe time-to-event outcomes and continuous outcomes, respectively. One hundred and thirty-eight patients were enrolled; median times from diagnosis to enrollment and follow-up were 6.6 and 39.6 months, respectively. Within 5 years of enrollment, 65% of patients had ≥1 red blood cell transfusion dependence episode. Within 5 years of diagnosis, 59% developed iron overload, 38% received iron chelation therapy, 14% progressed to acute myeloid leukemia, and 42% died. Patients exhibited inferior health-related quality of life trends. These first real-world data in LR MDS-RS in Canada indicate a high level of morbidity and mortality over a 5-year period. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT02537990.

An Intervention to Promote Adherence to Glasses Wearing Among Urban Public Elementary School Students: Associations With Classroom Behavior.

Glasses wearing at school remains low even when glasses are provided. This study investigated whether a classroom intervention to promote glasses wearing was associated with increased glasses wearing and improved classroom behavior. A pretest, posttest design was implemented with 44 students in Grades 1-4 at an urban public elementary school. Over 5 weeks, teachers encouraged eyeglass wearing through a classroom tracker, verbal reminders, and incentives. Glasses wearing and student behavior were monitored using the Direct Behavior Rating Scale of academic engagement and behavior for 13 weeks, including 4 weeks before and after the intervention. Glasses wearing increased from 56% to 73% (95% confidence interval [CI] = [0.08, 0.26]) in the first 2 weeks of the intervention, but not after a spring recess. The intervention was associated with significantly improved academic engagement (4.31%, 95% CI [2.17, 6.45]), respect (3.55%, 95% CI [1.77, 5.34]), and disruption (-4.28%, 95% CI [-6.51, -2.06]) compared to baseline. Higher academic engagement and disruption persisted 4 weeks after the intervention ended. A classroom-based glasses tracking and incentive system is associated with improved eyeglass wearing and classroom behavior among elementary students. A longer term randomized trial is needed to confirm these promising results.

Classroom Temperatures and Asthma-Related School-Based Health Care Utilization: An Exploratory Study.

OBJECTIVE: Schools with aging infrastructure may expose students to extreme temperatures. Extreme outdoor temperatures have previously been linked to more asthma-related health care utilization. Explore the relationship between classroom temperatures and school-based health care visits for asthma in an urban school building with an outdated heating and cooling system. METHODS: Participants were students in grades K-8 who received health care from a school-based health center (SBHC) (n = 647) or school nurse (n = 1244) in 2 co-located urban public schools between 2016 and 2018. The probability of an asthma visit to the SBHC or school nurse was modeled as a function of indoor temperature exposure using generalized estimating equations with covariates accounting for grade, sex, outdoor temperature, days at risk of asthma visit, nonasthma visits, month, and year fixed effects. RESULTS: Classroom temperatures ranged from 48.0˚F to 100.6°F. Higher mean grade-level indoor temperatures from a baseline of approximately 70˚F to 76˚F were associated with increased rates of asthma-related visits to the SBHC or school nurse on same day of exposure. Model-generated estimates suggest that an increase of 10˚F in indoor temperature relative to a baseline of 75˚F was associated with a 53% increase in the rate of asthma-related SBHC visits. CONCLUSIONS: Elevated classroom temperatures may be associated with more school-based health care utilization for asthma. Low-income and students from racial and ethnic minority groups have disproportionately higher rates of asthma and are also more likely to attend schools with poor infrastructure. The potential benefits of school infrastructure investments for student health, health care costs, and health equity merit further investigation.

Indirect comparisons of siponimod with fingolimod and ofatumumab in multiple sclerosis: assessing the feasibility of propensity score matching analyses.

OBJECTIVE: Head-to-head trials comparing siponimod with fingolimod or ofatumumab in patients with multiple sclerosis (MS) are lacking. Instead, the comparative efficacy of siponimod can be derived from indirect treatment comparisons (ITCs). We assessed the suitability of ITCs leveraging individual patient data from relevant phase III trials across different MS phenotypes. METHODS: One siponimod trial in patients with secondary progressive MS (SPMS), four fingolimod trials (three in relapsing-remitting MS [RRMS], and one in primary progressive MS [PPMS]), and two ofatumumab trials in relapsing MS (RMS) were considered. The suitability of ITCs was evaluated based on trial design, patient eligibility criteria, baseline patient characteristics, placebo response, and outcome definitions for each trial. Analyses deemed feasible were conducted using one-to-one propensity score matching (PSM). RESULTS: An ITC between siponimod in SPMS and either fingolimod in RRMS or ofatumumab in RMS was not feasible because of insufficient overlap in key patient characteristics (e.g. disability level and relapse history) and differences in placebo response. However, a comparison between siponimod in SPMS and fingolimod in PPMS was feasible because of sufficient overlap in eligibility criteria and baseline characteristics. One-to-one PSM demonstrated siponimod was favored relative to fingolimod for time to 6- and 3-month confirmed disability progression though not significantly different (hazard ratio 0.76 [95% confidence interval 0.48-1.20; p-value = .240] and hazard ratio 0.80 [95% confidence interval 0.52-1.22; p-value = .300], respectively). CONCLUSIONS: For trials in MS, clinical phenotype is an important determinant of ITC feasibility. An ITC between siponimod in SPMS and either fingolimod in RRMS or ofatumumab in RMS was not feasible. The only feasible comparison was between siponimod in SPMS and fingolimod in PPMS.

Effectiveness of Radiofrequency Catheter Ablation Using Ablation Index Versus Second Generation Cryoballoon in the Treatment of Persistent Atrial Fibrillation: A Matching-Adjusted Indirect Comparison.

INTRODUCTION: Both radiofrequency (RF) and cryoballoon (CB) ablation are treatment options for persistent atrial fibrillation (PsAF). An important recent innovation in RF ablation is Ablation Index (AI), known also as the VISITAG SURPOINT™ Module, a composite lesion quality marker whose use has been shown to significantly reduce the incidence of acute and late pulmonary vein (PV) reconnection and the recurrence of atrial arrhythmias in PsAF. Due to a lack of direct comparative evidence between the latest generations of technologies, there is uncertainty regarding the best treatment option in PsAF. The objective of the present study was to conduct a matching-adjusted indirect treatment comparison (MAIC) using individual patient-level data (IPD) to assess the comparative effectiveness of the THERMOCOOL SMARTTOUCH™ Catheter or the THERMOCOOL SMARTTOUCH™ SF Catheter with AI/VISITAG SURPOINT™ Module (STAI) versus the second-generation CB catheter (Arctic Front Advance™; herein referred to as CB) with respect to 12-month atrial arrhythmia recurrence, fluoroscopy time, and procedural efficiency. METHODS: IPD for STAI were obtained from four investigator-initiated studies and were pooled. Comparable CB studies identified from a systematic literature review were also pooled. In the absence of a common treatment arm between STAI and CB studies, an unanchored MAIC was conducted. The primary analysis compared the pooled STAI IPD to the pooled CB cohort, with corrections for differences across trials, including eligibility criteria and patient baseline characteristics. Scenario and sensitivity analyses were conducted to assess the robustness of the primary analysis. RESULTS: In the primary analysis, which was adjusted for left atrial diameter (LAD), age, diabetes, and sex, STAI was associated with a statistically significant 65% relative reduction in the rate of arrhythmia recurrence compared to CB at 12-month follow-up (HR 0.35; 95% CI 0.23, 0.52). STAI was associated with shorter total fluoroscopy time than CB but longer procedure time. Results were consistent across scenario and sensitivity analyses. CONCLUSION: Radiofrequency ablation with AI significantly reduced atrial arrhythmia recurrence at 12-month follow-up and fluoroscopy time compared to CB, with longer procedure times.

Indirect Treatment Comparison of Liso-Cel vs. Salvage Chemotherapy in Diffuse Large B-Cell Lymphoma: TRANSCEND vs. SCHOLAR-1.

Most patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) have exhausted their treatment options and are deemed palliative. CD19-directed chimeric antigen receptor (CAR) T-cell therapy has recently been introduced as a new option for these patients. Lisocabtagene maraleucel (liso-cel) is an investigational CAR T-cell therapy that has shown promising activity in this setting. We used an unanchored matching-adjusted indirect comparison (MAIC) methodology to compare liso-cel, using individual patient-level data from the TRANSCEND NHL 001 (TRANSCEND; NCT02631044) trial, to salvage chemotherapy, using summary-level data from the SCHOLAR-1 study, for the treatment of patients with R/R LBCL. Standardized mean differences were used to evaluate imbalances between the TRANSCEND and SCHOLAR-1 studies. MAIC was conducted to determine the relative efficacy of liso-cel vs. salvage chemotherapy with regard to overall survival, complete response rate, and objective response rate. For all efficacy outcomes assessed, comparisons of clinical factors before MAIC showed that five of seven baseline characteristics were similar between the TRANSCEND and SCHOLAR-1 studies; however, age and R/R to last therapy status differed between studies, thus requiring matching and adjusting to ensure the validity of this analysis. The base case analyses demonstrated a significantly lower risk of mortality (hazard ratio, 0.5; 95% confidence interval [CI] 0.4-0.6; p < 0.001) with significantly higher rates of complete response (odds ratio, 12.9; 95% CI 8.0-20.7) and objective response (odds ratio, 7.0; 95% CI 4.6-10.5) for patients treated with liso-cel than patients treated with salvage chemotherapy. MAIC comparisons demonstrated favorable efficacy for liso-cel compared with salvage chemotherapy in the treatment of patients with R/R LBCL.Trial Registration ClinicalTrials.gov identifier: NCT02631044.

Higher Child Body Mass Index Is Associated with Greater School-Based Health Center Utilization.

Background: Children with overweight status and obesity seek care for acute illnesses more often than normal weight peers. School-based health centers (SBHCs) have a role in acute and chronic disease management; however, little is known about SBHC use by children with overweight status and obesity. This study compared SBHC utilization by student body mass index (BMI) category and investigated whether SBHC visit diagnoses varied by BMI category. Methods: We performed a retrospective analysis of students (n = 1161) in grades K-8 enrolled in a large SBHC for 2 years. Negative binomial regression models were used to test the independent association between BMI category as defined by BMI percentile [normal/underweight (BMI percentile <85%) and overweight/obesity (BMI percentile ≥85%), either overweight (85% ≤BMI percentile <95%) or obesity (BMI percentile ≥95%)], and the number of SBHC visits (nurse, clinician, and total visits) for the 2-year interval. Top five diagnoses based on ICD-10 visit codes were compared. Results: Students in the overweight/obesity category (BMI percentile ≥85%) had higher visit rates than normal/underweight peers after adjusting for age and gender, but only total visits were statistically significant [nurse: incident rate ratio (IRR) 1.42 (95% CI 0.94-2.15); clinician: 1.27 (95% CI 0.93-1.75); total: 1.45 (95% CI 1.02-2.07)]. Visit diagnoses were similar by BMI category. Conclusions: Students with higher BMI percentiles, categorized as overweight/obesity, had higher SBHC utilization than normal/underweight peers, but visit diagnoses were similar. This higher utilization may provide an as-yet untapped opportunity to expand school-based obesity prevention and management.

Treatment of Atrial Fibrillation Using Ablation Index-Guided Contact Force Ablation: A Matching-Adjusted Indirect Comparison to Cryoballoon Ablation.

INTRODUCTION: Ablation Index, also known as VISITAG SURPOINT™, is a novel lesion-quality marker that improves outcomes in radiofrequency (RF) catheter ablation of atrial fibrillation (AF). There is no direct evidence on the comparative effectiveness of RF ablation with Ablation Index and cryoballoon (CB). The objective of the present study was to conduct a matching-adjusted indirect comparison (MAIC) using individual patient-level data (IPD) to compare the effectiveness of RF ablation with Ablation Index to that of CB on recurrence of atrial arrhythmias 12 months after catheter ablation in patients with paroxysmal AF (PAF). METHODS: Individual patient-level data for RF ablation with Ablation Index were obtained from two studies: Solimene et al. [J Interv Card Electrophysiol 54(1):9-15, 2019] and Hussein et al. [J Cardiovasc Electrophysiol 28(9):1037-1047, 2017]. Comparable CB studies identified from a systematic literature review were pooled. Prognostic variables for adjustment were ranked a priori by several practicing electrophysiologists. In the absence of a common treatment arm between the Ablation Index and CB studies, an unanchored MAIC was conducted. Primary analysis compared the Solimene et al. study to pooled CB studies. A secondary analysis compared pooled RF ablation with Ablation Index studies to pooled CB studies. Several scenario and sensitivity analyses were conducted. RESULTS: Primary analyses showed statistically significant reductions in the rate of arrhythmia recurrence with RF ablation with Ablation Index compared to CB in unmatched, unadjusted (HR 0.50, 95% CI 0.27-0.95) and matched (0.42, 0.21-0.86) analyses. Greater reductions in the rate of arrhythmia recurrence that favored RF ablation with Ablation Index were observed after matching and adjusting for age (0.41, 0.20-0.85), age and left ventricular ejection fraction (0.37, 0.16-0.88), and age, sex, and left ventricular ejection fraction (0.30, 0.13-0.71). Secondary and sensitivity analyses showed similar reductions. CONCLUSIONS: Radiofrequency ablation with Ablation Index was associated with reductions in recurrence of atrial arrhythmias at 12 months compared to CB in unmatched and unadjusted, matched, and matched and adjusted comparisons.

Asthma and Attendance in Urban Schools.

INTRODUCTION: Asthma is linked to student absenteeism, a risk factor for poor achievement and school dropout. Studies of asthma and absenteeism have common limitations, including relying on parent-reported asthma, which may be unreliable and prone to selection, and inadequately accounting for confounding health and social risks. Therefore, the rate of absenteeism attributable to asthma and the extent to which better asthma control would translate into better attendance remain unclear. METHODS: Participants were 1,194 students in 2 large urban US schools (1 elementary, 1 middle) in 2016-2018. Student asthma was assessed based on parent report on health forms, student-reported asthma-related emergency department/hospitalization or medication use, and school health center record of asthma. Multiple imputation was used to reduce selection from missing asthma reports. The relationship between asthma and school district-reported days absent was estimated using Poisson random intercept regression, accounting for health and demographic covariates. RESULTS: Parent-reported ever asthma (27%) was not associated with absenteeism in adjusted models. Student-reported asthma health care or medication use (16%) and school health center record of asthma (17%) were associated with higher absenteeism (incidence rate ratio [IRR], 1.16; 95% confidence interval [CI], 1.01-1.35 and IRR, 1.21; 95% CI, 1.09-1.34, respectively). Student-reported asthma and school health center record of asthma were associated with 1.9 and 1.5 absences per year, respectively. CONCLUSION: Student-reported and school health center record of asthma explained 14% to 18% of student absenteeism, even after accounting for other health and social risks. When possible, student reports should supplement parent reports to ensure that students with asthma are identified and obtain access to care.

A Cost Analysis of Salbutamol Administration by Metered-Dose Inhalers with Spacers versus Nebulization for Patients with Wheeze in the Pediatric Emergency Department: Evidence from Observational Data in Nova Scotia.

BACKGROUND: Despite evidence demonstrating the advantages of metered-dose inhalers with spacers (MDI-s), nebulization (NEB) remains the primary method of asthma treatment in some pediatric emergency departments (PEDs). There is a perception that delivering salbutamol by MDI-s is more costly than by NEB. This research evaluates the relative costs of MDI-s and NEB using local, hospital-specific, patient-level data. METHODS: Regression models estimated associations between the salbutamol inhalation method and costs, length of stay (LOS) in the PED and hospital, and the probability of admission. Our population was a random sample of 822 patients presenting with wheeze to the PED in 2008/2009. Control variables included age, sex, triage acuity, time of PED visit, other medications, and vitals. Costs were calculated using the prices and quantities of medical resources used per treatment. Probabilistic sensitivity analysis was used. RESULTS: Treatment with MDI-s versus NEB was associated with an absolute decrease in hospitalization of 4.4% (p<0.05) and a 25-hour (p<0.001) reduction in average inpatient stay, after controlling for triage acuity and patient characteristics. This resulted in savings of $24/patient in the PED and $180/patient overall (p<0.001). Inpatient care accounted for more than 90% of total patient costs. CONCLUSIONS: Our results suggest economic gains associated with MDI-s for salbutamol inhalation in PEDs. Sensitivity analyses show that this conclusion is not affected by changes in model parameters that may differ by jurisdiction. Since most facilities already collect the data used for this study, our methods could be adopted for a cross-jurisdictional account of the cost effectiveness of MDI-s.