Impact of Daily Growth Hormone Adherence on Height Velocity among Children with Growth Hormone Deficiency (GHD).

OBJECTIVE: To describe adherence to daily somatropin treatment and impact on height velocity within one year of treatment start among patients with pediatric growth hormone deficiency (pGHD) in a real-world US population. METHODS: This retrospective cohort study included pediatric patients ages ≥3 years to <16 years old with pGHD prescribed somatropin by a pediatric endocrinologist at a US-based center of excellence between 01/01/2015 and 12/31/2020. Patient data was collected using hospital electronic health records linked to a specialty pharmacy patient prescription records. Adherence, evaluated over 12 months, was measured using the proportion of days covered (PDC) metric and patients were categorized as adherent if their PDC≥80%. Height velocity was annualized to compare across adherent and non-adherent patients. RESULTS: 181 patients were identified and included in this study, of which 70.2% were male,73.5% were white and mean age (standard deviation [SD]) at index was 12.1 (2.8). In the height velocity analysis, 174 patients were included and the mean (SD) annualized change in height was 10.2 (5.7) cm/year in the adherent group (n=108) and 9.8 (7.6) in the non-adherent group (n=66). The difference in HV between the groups was not statistically significant. CONCLUSIONS: Minor improvements in average HV were observed in the patient group who were adherent to somatropin therapy, although not statistically significant. Lack of observed significance may be due to small sample sizes, short observation period, a likely heterogenous population in terms of growth hormone prescribing, data bias due to single-center origin or potential patient misclassification.

Economic burden of comorbid insomnia in 5 common medical disease subgroups.

STUDY OBJECTIVES: Approximately 85% of insomnia co-occurs with other disorders. Whereas insomnia was once considered "secondary" to these disorders, it is now widely recognized as an independent condition warranting treatment. While it is clear that insomnia can affect the course of other medical conditions, there is scant literature on the economic impact of comorbid insomnia among patients with common medical conditions. The aim of this study was to determine the economic burden of comorbid insomnia in 5 medical diseases commonly associated with insomnia: type 2 diabetes mellitus (T2DM), cancer undergoing treatment, menopause undergoing hormone replacement therapy, osteoporosis, and Alzheimer's disease and related dementias (ADRDs). METHODS: This retrospective cohort study used claims data from the IBM MarketScan Commercial and Medicare Supplemental Databases from January 1, 2014, through December 31, 2019. Insomnia and comorbid disease groups were defined using physician-assigned International Classification of Diseases diagnostic codes. Insomnia medication treatment was defined based on ≥1 prescription fills for the most commonly prescribed insomnia medications (zolpidem, low-dose trazodone, and benzodiazepines [as a class]). For each comorbid disease subgroup, 4 cohorts were created: (1) patients with either treated or untreated insomnia, (2) non-sleep-disordered controls, (3) patients with untreated insomnia, and (4) patients with treated insomnia. RESULTS: Sample sizes for individuals with comorbid insomnia ranged from 23,168 (T2DM) to 3,015 (ADRDs). Within each disease subgroup and relative to non-sleep-disordered controls, patients with comorbid insomnia demonstrated greater adjusted health care resource utilization and costs across most points of service. Likewise, relative to individuals with untreated insomnia, those with treated insomnia generally demonstrated greater adjusted health care resource utilization and costs. CONCLUSIONS: In this national analysis, both untreated comorbid insomnia and comorbid insomnia treated with commonly prescribed insomnia medications were associated with increased health care resource utilization and costs across most points of service. CITATION: Wickwire EM, Juday TR, Kelkar M, Heo J, Margiotta C, Frech FH. Economic burden of comorbid insomnia in 5 common medical disease subgroups. J Clin Sleep Med. 2023;19(7):1293-1302.

Analytical methods for evaluating reliability and validity of mobile audiometry tools.

Statistical approaches that could be used as standardized methodology for evaluating reliability and validity of data obtained using remote audiometry are proposed. Using data from the Nurses' Health Study II (n = 31), the approaches to evaluate the reliability and validity of hearing threshold measurements obtained by a self-administered iPhone-based hearing assessment application (Decibel Therapeutics, Inc., Boston, MA) compared with measurements obtained by clinical (soundbooth) audiometry are described. These approaches use mixed-effects models to account for multilevel correlations, intraclass correlation coefficients (ICCs) of single and averaged measurements, and regression techniques with the generalized estimating equations (GEEs) to account for between-ear correlations. Threshold measurements obtained using the iPhone application were moderately reliable. The reliability was improved substantially by averaging repeated measurements; good reliability was achieved by averaging three repeated measurements. In the linear regression analyses that assessed validity, the range of intercepts (2.3-8.4) and range of slopes (0.4-0.7) indicated that the measurements from the application were likely biased from those obtained by clinical audiometry. When evaluating alternative hearing assessment tools, it is recommended to assess reliability through mixed-effects models and use ICCs to determine the number of repeated assessments needed to achieve satisfactory reliability. When evaluating validity, GEE methods are recommended to estimate regression coefficients.

Cytomegalovirus-Associated Venous and Arterial Thrombotic Disease.

BACKGROUND: Cytomegalovirus (CMV) infection has been associated with venous thromboembolism (VTE) and acute coronary syndromes (ACS). METHODS: A retrospective study was conducted within the OSF HealthCare System in Peoria, IL. The objectives were to determine the incidence of acute VTE and ACS within one year of CMV testing. The "study group" included patients with positive CMV immunoglobulin M (IgM) or positive CMV polymerase chain reaction (PCR). The "seropositive control" group included patients with positive CMV immunoglobulin G (IgG) and negative IgM. The "seronegative control" group included patients with negative CMV IgG and IgM, or negative PCR. RESULTS: Within one year of CMV infection, 38 of 379 patients (10.0%) developed VTE in the study group compared to 41 of 1334 patients (3.1%) in the seropositive control and 37 of 1249 (3.0%) in the seronegative control. Adjusting for age and gender, both control groups were less likely to have VTE than the study group within one year (seropositive control: odds ratio (OR) = 0.3, 95% confidence interval (CI) 0.2-0.5, p < 0.0001; seronegative control: OR = 0.4, 95% CI 0.2-0.6, p < 0.0001). ACS was more likely to occur in the study group, with the incidence of 7.7% compared to 4.7% (p < 0.0001) in the seropositive control and 1.9% (p <0.0001) in the seronegative control. Adjusting for age and gender, the seronegative control was less likely to develop ACS than the study group within one year (OR = 0.4, 95% CI 0.2-0.7, p = 0.003). CONCLUSIONS: This retrospective study demonstrates that CMV infection may be a significant risk factor for VTE and ACS.

The Prevalence and Payer Costs of Potentially Avoidable Emergent Care Visits for Suspected Amniotic Membrane Rupture in Pregnant Women.

BACKGROUND: Concern over amniotic fluid leakage is common among pregnant women. Uncertainty about prelabor rupture of amniotic membranes (PROM) can lead women to present to emergency departments or to labor and delivery units for medical evaluation. Many of such visits do not result in delivery, yet they carry significant, and potentially unnecessary, healthcare expenditures. OBJECTIVE: To estimate the prevalence and payer cost of potentially avoidable visits by pregnant women to an emergent care facility (including emergency departments, labor and delivery units, or observation units) for suspected PROM. METHODS: This study included 2 processes-an electronic medical records chart review and a commercial health insurance claims data analysis. The medical chart review included 843 scheduled and 1250 unscheduled pregnancy-related visits at Robert Wood Johnson University Hospital between January 4 and June 30, 2017, which was conducted to determine the rates of visits by pregnant women with suspected PROM and their results (ie, hospital admission or discharge). In addition, we performed a retrospective analysis of medical claims data from the Truven Health MarketScan Commercial Database to measure population-level incidence rates and the costs of pregnancy-related emergent care visits for suspected PROM. RESULTS: Of the 1250 unscheduled visits reviewed, 663 did not result in delivery; of these, 68 had a primary complaint of suspected PROM, and 55 (81%) of them were discharged with PROM ruled out. Of all scheduled and unscheduled nondelivery visits (N = 1069), 5.1% (N = 55) were associated with suspected PROM but were discharged home with PROM ruled out. In the commercial claims analysis, the average rate of emergent care visits by pregnant women was 436.69 per 1000 deliveries, with an estimated average cost of $1428 per visit (in 2018 dollars), or $0.58 per member per month. Applying the rates from our chart review to the claims data, we estimated that commercial insurers pay, on average, for approximately 22.47 facility visits per 1000 deliveries for suspected and ruled-out PROM. CONCLUSIONS: Our findings suggest that for most PROM cases that do not result in delivery, PROM is ruled out and patients are sent home. Reducing the number of PROM-related visits to emergent care facilities that result in ruled-out PROM could reduce healthcare costs and help patients and providers avoid these inconvenient visits.