A Randomized,Placebo-Controlled Study to Investigate the Safety,Tolerability, and Pharmacokinetics of 3 Weeks of Orally Administered Gefapixant in Healthy Younger and Older Adults

Purpose

Patients with chronic cough are typically female and have a mean age of?~?60 years. However, initial pharmacokinetic (PK) characterization of the P2X3-receptor antagonist gefapixant, developed to treat refractory or unexplained chronic cough, was performed in healthy participants who were predominantly younger adult males. The objective of this Phase 1 study was to assess the safety, tolerability, and PK of gefapixant in younger (18–55 years) and older (65–80 years) males and females.

Methods

A randomized, double-blind, placebo-controlled study was conducted. Healthy adult participants were stratified into 4 cohorts by age and sex (younger males/females and older males/females) and randomized 4:1 (younger adults) or 3:1 (older adults) to receive gefapixant 300 mg twice daily (BID) for 1 week, followed by gefapixant 600 mg BID for 2 weeks or placebo. Safety, tolerability, and PK were assessed.

Results

Of 36 randomized and treated participants, 28 (100%) receiving gefapixant and 6 (75%) receiving placebo reported?≥?1 adverse event (AE). The most common treatment-related AEs in the gefapixant group were taste related. Predefined renal/urologic AEs were reported by 7 (25%) participants receiving gefapixant (all mild to moderate in severity). Gefapixant exposure was generally lower in younger males compared with younger females and older adults; however, differences may have been due to estimated glomerular filtration rate.

Conclusion

The safety profile of gefapixant 300–600 mg BID was generally consistent with previous studies. Additional characterization of gefapixant PK as a function of age and sex using population PK modeling is warranted.

     

Weight status,diet quality,perceived stress,and functional health of caregivers of children with autism spectrum disorder

1 Purpose

Caring for children with autism spectrum disorder (ASD) can be highly demanding and can put significant strain on caregivers. To date, little is known about the extent to which caregivers of children with ASD experience increased levels of stress which may adversely affect health outcomes. The purpose of this secondary analysis was to compare caregivers of children with ASD and caregivers of typically developing children (TDC) in weight status, diet quality, perceived stress related to the parenting role, and functional health and well‐being.

2 Design and methods

Caregivers of 25 children with ASD and 30 TDC completed the 2005 Block Food Frequency Questionnaire, the 36‐item Short Form of the Parenting Stress Index (PSI/SF), and the Short Form Health Survey (SF‐36) and had their heights and weights measured during an onsite visit. Diet quality was assessed using the Healthy Eating Index (HEI)‐2010 and its dietary components and conformance to the 2010 Dietary Guidelines for Americans.

3 Results

ASD caregivers did not differ significantly from TDC caregivers in body mass index or overweight/obesity prevalence (p ≥ .28), even when controlling for covariates. In univariate analyses, ASD caregivers consumed significantly fewer empty calories from solid fats, alcohol, and added sugars than TDC caregivers (p = .03), but they did not differ significantly in any other dietary outcomes including nutrient adequacy (p ≥ .10) and mean total HEI scores (p = .20). ASD caregivers, when compared to TDC caregivers, reported significantly greater parenting stress for the subscales difficult child and parent–child dysfunctional interaction as well as total stress (p < .001). In addition, 56% of ASD caregivers compared with 6.7% of TDC caregivers showed clinically significant levels of stress (p < .0001); a finding which remained statistically significant when controlling for covariates. ASD and TDC caregivers did not differ significantly in any SF‐36 health domains related to functional health and well‐being (p ≥ .10).

4 Practice implications

Despite higher reported levels of stress, ASD caregivers did not differ significantly from TDC caregivers in diet‐ and health‐related outcomes. Nurses and other health professionals should use comprehensive screening tools to assess overall caregiver stress and levels of resilience.     

Segway® Personal Transporter-Related Injuries: A Systematic Literature Review and Implications for Acute and Emergency Care

Background

The Segway® Personal Transporter? (SPT) is used widely as a means of transport for city sightseeing tours, law enforcement, and professionals working in large facilities and factories.

Suicide screening scales may not adequately predict disposition of suicidal patients from the emergency department

Background

Suicide screening scales have been advocated for use in the ED setting. However, it is currently unknown whether patients classified as low-risk on these scales can be safely discharged from the emergency department. This study evaluated the utility of three commonly-used suicide screening tools in the emergency department to predict ED disposition, with special interest in discharge among low-risk patients.

Enhancing health policymakers' information literacy knowledge and skill for policymaking on control of infectious diseases of poverty in Nigeria

Background

In Nigeria, one of the major challenges associated with evidence-to-policy link in the control of infectious diseases of poverty (IDP), is deficient information literacy knowledge and skill among policymakers. There is need for policymakers to acquire the skill to discover relevant information, accurately evaluate retrieved information and to apply it correctly.

Objectives

To use information literacy tool of International Network for Availability of Scientific Publications (INASP) to enhance policymakers'' knowledge and skill for policymaking on control of IDP in Nigeria.

Methods

Modified "before and after" intervention study design was used in which outcomes were measured on target participants both before the intervention is implemented and after. This study was conducted in Ebonyi State, south-eastern Nigeria and participants were career health policy makers. A two-day health-policy information literacy training workshop was organized to enhance participants" information literacy capacity. Topics covered included: introduction to information literacy; defining information problem; searching for information online; evaluating information; science information; knowledge sharing interviews; and training skills.

Results

A total of 52 policymakers attended the workshop. The pre-workshop mean rating (MNR) of knowledge and capacity for information literacy ranged from 2.15-2.97, while the post-workshop MNR ranged from 3.34-3.64 on 4-point scale. The percentage increase in MNR of knowledge and capacity at the end of the workshop ranged from 22.6%-55.3%.

Conclusion

The results of this study suggest that through information literacy training workshop policy makers can acquire the knowledge and skill to identify, capture and share the right kind of information in the right contexts to influence relevant action or a policy decision.     

Noble-gas-infused neoprene closed-cell foams achieving ultra-low thermal conductivity fabrics

Closed-cell foams are widely applied as insulation and essential for the thermal management of protective garments for extreme environments. In this work, we develop and demonstrate a strategy for drastically reducing the thermal conductivity of a flexible, closed-cell polychloroprene foam to 0.031 ± 0.002 W m⁻¹ K⁻¹, approaching values of an air gap (0.027 W m⁻¹ K⁻¹) for an extended period of time (>10 hours), within a material capable of textile processing. Ultra-insulating neoprene materials are synthesized using high-pressure processing at 243 kPa in a high-molecular-weight gas environment, such as Ar, Kr, or Xe. A Fickian diffusion model describes both the mass infusion and thermal conductivity reduction of the foam as a function of processing time, predicting a 24–72 hour required exposure time for full charging of a 6 mm thick 5 cm diameter neoprene sample. These results enable waterproof textile insulation that approximates a wearable air gap. We demonstrate a wetsuit made of ultra-low thermally conductive neoprene capable of potentially extending dive times to 2–3 hours in water below 10 °C, compared with <1 hour for the state-of-the-art. This work introduces the prospect of effectively wearing a flexible air gap for thermal protection in harsh environments.

Herein, we develop, demonstrate, and model a repeatable process for synthesizing ultra-low-thermal-conductivity closed-cell neoprene garments by infusing high-molecular-weight noble gases.