Does Assessor Masking Affect Kindergartners' Performance on Oral Language Measures? A COVID-19 Era Experiment With Children From Diverse Home Language Backgrounds.

PURPOSE: The ongoing COVID-19 pandemic has prompted changes to child assessment procedures in schools such as the use of face masks by assessors. Research with adults suggests that face masks diminish performance on speech processing and comprehension tasks, yet little is known about how assessor masking affects child performance. Therefore, we asked whether assessor masking impacts children's performance on a widely used, individually administered oral language assessment and if impacts vary by child home language background. METHOD: A total of 96 kindergartners (5-7 years old, n = 45 with a home language other than English) were administered items from the Clinical Evaluation of Language Fundamentals Preschool-Second Edition Recalling Sentences subtest under two conditions: with and without the assessor wearing a face mask. Regression analysis was used to determine if children scored significantly lower in the masked condition and if the effect of masking depended on home language background. RESULTS: Contrary to expectations, we found no evidence that students scored systematically differently in the masked condition. Children with a home language other than English scored lower overall, but masking did not increase the gap in scores by language background. CONCLUSIONS: Our results suggest that children's performance on oral language measures is not adversely affected by assessor masking and imply that valid measurements of students' language skills may be obtained in masked conditions. While masking might decrease some of the social determinants of communication (e.g., recognition of emotions), masking in this experiment did not appear to detract from children's ability to hear and immediately recall verbal information. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.23567463.

Epinephrine Administered in Anaphylaxis: The Evolution of 0.3 mg Dosage.

Background: Despite epinephrine's historical use for over a century and Food and Drug Administration (FDA) approval for EpiPen's use in 1987 to treat anaphylaxis, little information exists regarding selection of the 0.3 mg adult dose. A review of literature was conducted to provide a historical retrospective regarding the evolution of the dosage selected for today's EpiPen. The first adrenal gland extract, isolation of the epinephrine active ingredient, observation of physiological effect, selection of the intramuscular route for administration, the dosage range recommended by independent physicians based on their clinical observations and selection of the ultimate standardized dosage are profiled. Conclusion: This retrospective review illustrates the drug development process prior to the rigors required for today's clinical trials and provides clinical evidence supporting the dose in EpiPen and other similar life-saving epinephrine products.

Virtual Teaching Together: engaging parents and young children in STEM activities.

Introduction: Early informal learning experiences are essential for sparking long-term interest in science, technology, engineering, and math (STEM). In a prior study, we found more promising parent involvement outcomes when families of young children were provided with STEM family education events along with home STEM activity kits compared to providing workshops alone. This study was a conceptual replication using the same program-Teaching Together STEM-to deliver educational workshops plus home activity kits; however, we varied the delivery method by using virtual "funshops" to evaluate if parents perceived this modality as feasible and useful. Methods: Museum informal science educators introduced four units via virtual video chat sessions linked to 12 hands-on STEM activities that were mailed to families randomly assigned to the treatment group. Half of the families were assigned to a waitlist control group that received a portion of the virtual program after the posttest. Participants included 60 families with children aged 3 to 5 years from diverse linguistic and socioeconomic backgrounds. Results: Our results indicate no significant group differences in the primary outcome of parents' involvement in informal STEM but a small, positive effect size (ES = 0.18) that was similar in magnitude to the prior, in-person study. Although parents mostly perceived the remote delivery as convenient and the materials as engaging for their child, there were no significant program impacts on children's general science interests (ES = -0.19). Discussion: Despite the convenience, parents reported time was a barrier to doing STEM activities at home. Parents with lower education levels were less likely to attend, suggesting virtual approaches are not sufficient for ensuring broad access to family engagement programs for populations underrepresented in STEM.

Effects of Intranasal Epinephrine on Cerebrospinal Fluid Epinephrine Pharmacokinetics, Nasal Mucosa, Plasma Epinephrine Pharmacokinetics, and Cardiovascular Changes.

PURPOSE: We aimed to assess intranasal (IN) epinephrine effects on cerebrospinal fluid (CSF) absorption, nasal mucosa quality, plasma epinephrine pharmacokinetics (PK), and cardiovascular changes in dogs. METHODS: CSF epinephrine concentration was measured and nasal mucosa quality was evaluated after IN epinephrine 4 mg and one or two 4 mg doses (21 min apart), respectively. Maximum plasma concentration [Cmax], time to Cmax [Tmax], area under the curve from 0 to 120 min [AUC0-120], and cardiovascular effects were evaluated after epinephrine IN (4 and 5 mg) and intramuscular (IM; 0.3 mg). Clinical observations were assessed. RESULTS: After epinephrine IN, there were no changes in CSF epinephrine or nasal mucosa. Cmax, Tmax, and AUC1-120 were similar following epinephrine IN and IM. Epinephrine IN versus IM increased plasma epinephrine at 1 min (mean ± SEM, 1.15 ± 0.48 for 4 mg IN and 1.7 ± 0.72 for 5 mg IN versus 0.47 ± 0.11 ng/mL for 0.3 mg IM). Epinephrine IN and IM produced similar heart rate and ECG results. Clinical observations included salivation and vomiting. CONCLUSIONS: Epinephrine IN did not alter CSF epinephrine or nasal tissue and had similar cardiovascular effects as epinephrine IM. Epinephrine IN rapidly increased plasma epinephrine concentration versus epinephrine IM.

Intranasal epinephrine in dogs: Pharmacokinetic and heart rate effects.

Epinephrine is the standard of care for the treatment of severe allergy and anaphylaxis. Epinephrine is most often administered through the intramuscular (IM) route via autoinjector. The current study aimed to evaluate an alternative method of epinephrine treatment through intranasal (IN) delivery in dogs. The pharmacokinetic (PK) parameters of maximum plasma concentration (Cmax ), time to reach maximum plasma concentration (Tmax ), and area under the plasma concentration-time curve from 0 to 90 minutes (AUC0-90 ) were observed after IN epinephrine (2, 3, 4, 5, 10, and 20 mg) and IM epinephrine via autoinjector (0.15 and 0.3 mg) for 90 minutes. Heart rate effects were measured after IN (2 and 5 mg) and IM (0.15 and 0.3 mg) epinephrine administration. IN epinephrine (5 mg) demonstrated significantly greater plasma epinephrine concentration at 1 minute as compared with IM epinephrine (0.3 mg) (1.68 ± 0.65 ng/mL vs 0.21 ± 0.08 ng/mL, P = .03). There were no significant differences in Cmax , Tmax , and AUC0-90 between 2-mg IN and 0.15-mg IM epinephrine or between 5-mg IN and 0.3-mg IM epinephrine. IN epinephrine reduced heart rate increases, as compared to IM epinephrine. IN and IM epinephrine were both well-tolerated. Overall, IN epinephrine demonstrated advantages over IM epinephrine, including the rapid increase in plasma epinephrine and lack of increased heart rate over time.

Intranasal epinephrine effects on epinephrine pharmacokinetics and heart rate in a nasal congestion canine model.

BACKGROUND: Histamine release and vasodilation during an allergic reaction can alter the pharmacokinetics of drugs administered via the intranasal (IN) route. The current study evaluated the effects of histamine-induced nasal congestion on epinephrine pharmacokinetics and heart rate changes after IN epinephrine. METHODS: Dogs received 5% histamine or saline IN followed by 4 mg epinephrine IN. Nasal restriction pressure, epinephrine concentration, and heart rate were assessed. Maximum concentration (Cmax), area under plasma concentration-time curve from 1 to 90 min (AUC1-90), and time to reach Cmax (Tmax) were measured. Clinical observations were documented. RESULTS: In the 12 dogs in this study, nasal congestion occurred at 5-10 min after IN histamine administration versus no nasal congestion after IN saline. After administration of IN epinephrine, IN histamine-mediated nasal congestion was significantly reduced to baseline levels at 60, 80, and 100 min. There were no significant differences in Cmax and AUC1-90 between histamine and saline groups after IN epinephrine delivery (3.5 vs 1.7 ng/mL, p = 0.06, and 117 vs 59 ng/mL*minutes, p = 0.09, respectively). After receiving IN epinephrine, the histamine group had a significantly lower Tmax versus the saline group (6 vs 70 min, respectively; p = 0.02). Following IN epinephrine administration, the histamine group showed rapidly increased heart rate at 5 min, while there was a delayed increase in heart rate (occurring 30-60 min after administration) in the saline group. Clinical observations included salivation and emesis. CONCLUSION: IN histamine led to more rapid epinephrine absorption and immediately increased heart rate compared with IN saline. IN epinephrine decreased histamine-induced nasal congestion.

Pharmacokinetics of diazepam administered intramuscularly by autoinjector versus rectal gel in healthy subjects: a phase I, randomized, open-label, single-dose, crossover, single-centre study.

BACKGROUND AND OBJECTIVE: Acute repetitive seizures (ARS) are a debilitating part of episodic seizure activity that can sometimes progress to status epilepticus. Currently approved treatment that can be administered by non-medical personnel to patients with ARS is a diazepam rectal gel. While effective, rectal administration can be difficult, inconvenient and objectionable. A diazepam autoinjector has been developed to deliver diazepam via an intramuscular (IM) injection. This study evaluated the dose proportionality of the diazepam autoinjector and the consequent diazepam bioavailability relative to an equivalent dose of diazepam administered rectally as a commercial gel. METHODS: This was a phase I, randomized, open-label, two-part, single-dose, crossover, single-centre pharmacokinetic study in 48 healthy young adult (aged 18-40 years) male and female subjects. Part I of the study (n = 24) evaluated the dose proportionality of three strengths of the diazepam autoinjector (5, 10 and 15 mg) administered into the mid-outer thigh via a deep IM injection. Part II (n = 24) assessed the relative bioavailability of the diazepam 10 mg autoinjector versus the diazepam 10 mg rectal gel. Parts I and II were run concurrently. Each subject completed screening up to 30 days prior to three (Part I) or two (Part II) dosing periods. Serial blood sampling for plasma diazepam and desmethyldiazepam (metabolite) concentrations, vital signs and adverse event (AE) assessments were performed at prespecified times. Treatments were separated by a 14-day washout period. RESULTS: In Part I, dose proportionality was demonstrated for the diazepam autoinjector at 5, 10 and 15 mg doses by increases in mean maximum plasma concentration (C(max)), mean area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC(∞)), and mean AUC from time zero to time of last measurable concentration (AUC(last)). The median time to reach C(max) (t(max)) was consistent at 1 hour for each dose. In Part II of the study, IM administration via diazepam autoinjector (10 mg) resulted in plasma concentrations of both diazepam and desmethyldiazepam that were slightly higher and less variable than those observed following administration of diazepam rectal gel (10 mg). The geometric mean ratio (diazepam autoinjector/diazepam rectal gel) and 90% confidence intervals for diazepam C(max) and AUC(last) were 0.94 (0.84, 1.05) and 1.14 (1.08, 1.21), respectively, indicating that the overall bioavailability of the diazepam autoinjector was approximately 14% higher than that of diazepam rectal gel. Both treatments were generally well tolerated. Although the incidence of treatment-emergent AEs was higher with diazepam autoinjector compared with diazepam rectal gel (21.7% vs 13.6%), the difference can be attributed to injection site pain. Injection site pain also correlated with the diazepam autoinjector dose administered in Part I: 5 mg (4.3%), 10 mg (21.7%) and 15 mg (27.3%). However, no patients discontinued the trial due to injection site pain. No other AEs correlated with dose, and there was no evidence of respiratory depression with either administration. CONCLUSION: Results of the present study indicated that diazepam can be safely and reliably administered IM using a diazepam autoinjector.