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Emerging issues in pediatric asthma: gaps in EPR-3 guidelines for infants and children.

ABSTRACT: There are many complexities to the treatment of infants and children with recurrent wheezing and asthma. The National Heart, Lung and Blood Institute's (NHLBI's) Expert Panel Report-3 (EPR-3), published in 2007, provides guidance to clinicians who care for infants and children with asthma. Since that time, many important clinical trials have further informed the evidence base available to clinicians. In this manuscript, new approaches to long-term therapy, intermittent fixed-dose and dynamic dose therapies, and emerging therapies for asthma are reviewed. Further, additional gaps in guideline-based care and areas for future research are discussed.

SUBMITTER: Jackson DJ

PROVIDER: S-EPMC4330969 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature

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Emerging issues in pediatric asthma: gaps in EPR-3 guidelines for infants and children.

Jackson Daniel J DJ

Current allergy and asthma reports 20141201 12

There are many complexities to the treatment of infants and children with recurrent wheezing and asthma. The National Heart, Lung and Blood Institute's (NHLBI's) Expert Panel Report-3 (EPR-3), published in 2007, provides guidance to clinicians who care for infants and children with asthma. Since that time, many important clinical trials have further informed the evidence base available to clinicians. In this manuscript, new approaches to long-term therapy, intermittent fixed-dose and dynamic dos ...[more]

PMID: 25269401

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Project description:Introduction: Respiratory distress accounts for approximately 14% of all pediatric emergency medical services (EMS) encounters, with asthma being the most common diagnosis. In the emergency department (ED), early administration of systemic corticosteroids decreases hospital admission and speeds resolution of symptoms. For children treated by EMS, there is an opportunity for earlier corticosteroid administration. Most EMS agencies carry intravenous (IV) corticosteroids; yet given the challenges and low rates of EMS pediatric IV placement, oral corticosteroids (OCS) are a logical alternative. However, previous single-agency studies showed low adoption of OCS. Therefore, qualitative study of OCS implementation by EMS is warranted.Methods: This study's objective was to explore uptake and implementation of OCS for pediatric asthma treatment through semi-structured interviews and focus groups with EMS clinicians. We thematically coded and analyzed transcripts using the domains and constructs of the Consolidated Framework for Implementation Research (CFIR) to identify barriers and facilitators that most strongly influenced OCS implementation and adoption by EMS clinicians.Results: We conducted five focus groups with a total of ten EMS clinicians from four EMS systems: one urban region with multiple agencies that hosted two focus groups, one suburban agency, one rural agency, and a mixed rural/suburban agency. Of the 36 CFIR constructs, 31 were addressed in the interviews. Most constructs coded were in the CFIR domains of the inner setting and characteristics of individuals, indicating that EMS agency factors as well as EMS clinician characteristics were impactful for implementation. Barriers to OCS adoption included unfamiliarity and inexperience with pediatric patients and pediatric dosing, and lack of knowledge of the benefits of corticosteroids. Facilitators included friendly competition with colleagues, having a pediatric medical director, and feedback from receiving EDs on patient outcomes.Conclusion: This qualitative focus group study of OCS implementation by EMS clinicians for the treatment of pediatric asthma found many barriers and facilitators that mapped to the structure of EMS agencies and characteristics of individual EMS clinicians. To fully implement this evidence-based intervention for pediatric asthma, more education on the intervention is required, and EMS clinicians will benefit from further pediatric training.

Project description:BackgroundPediatric asthma has been identified by regulators, clinicians, clinical trial sponsors, and caregivers as an area in need of novel fit-for-purpose clinical outcome assessments (COAs) developed in accordance with the U.S. Food and Drug Administration's (FDA's) regulatory guidance for evaluating clinical benefit in treatment trials. To address this gap, the Patient-Reported Outcome (PRO) Consortium's Pediatric Asthma Working Group has continued development of 2 COAs to assess asthma signs and symptoms in pediatric asthma clinical trials to support efficacy endpoints: a PRO measure, the Pediatric Asthma Diary-Child (PAD-C) for children 8-11 years old (y.o.) and an observer-reported outcome measure, the Pediatric Asthma Diary-Observer (PAD-O) for caregivers of children 4-11 y.o. This qualitative research aimed to generate evidence regarding the content validity of the PAD-C and PAD-O.MethodsSemi-structured combined concept elicitation and cognitive interviews were conducted with a diverse sample of U.S. participants (15 children 8-11 y.o. and 30 caregivers of children 4-11 y.o.). All children had clinician-diagnosed mild to severe asthma. Interviews explored the experience of pediatric asthma and assessed the understanding and relevance of both measures. Interviews were conducted across 3 iterative rounds to allow for modifications.ResultsConcept elicitation findings demonstrated that the core sign/symptom and impact concepts assessed in the PAD-C (cough, hard to breathe, out of breath, wheezing, chest tightness, and nighttime awakenings/symptoms) and PAD-O (cough, difficulty breathing, short of breath, wheezing, and nighttime awakenings/signs) correspond to those most frequently reported by participants; concept saturation was achieved. All PAD-C and PAD-O instructions and core items were well understood and considered relevant by most participants. Feedback from participants, the Pediatric Asthma Working Group, advisory panel, and FDA supported modifications to the measures, including addition of 1 new item to both measures and removal of 1 caregiver item.ConclusionsFindings provide strong support for the content validity of both measures. The cross-sectional measurement properties of both measures and their user experience and feasibility in electronic format will be assessed in a future quantitative pilot study with qualitative exit interviews, intended to support the reliability, construct validity, final content, and, ultimately, FDA qualification of the measures.

Dataset Information

Emerging issues in pediatric asthma: gaps in EPR-3 guidelines for infants and children.

Publications

Emerging issues in pediatric asthma: gaps in EPR-3 guidelines for infants and children.

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