Acute severe paediatric asthma: Study protocol for the development of a core outcome set, a Pediatric Emergency Research Networks (PERN) study

BackgroundAcute severe childhood asthma is an infrequent, but potentially life-threatening emergency condition. There is a wide range of different approaches to this condition, with very little supporting evidence, leading to significant variation in practice. To improve knowledge in this area, there must first be consensus on how to conduct clinical trials, so that valid comparisons can be made between future studies. We have formed an international working group comprising paediatricians and emergency physicians from North America, Europe, Asia, the Middle East, Africa, South America, Central America, Australasia and the United Kingdom.Methods/designA 5-stage approach will be used: (1) a comprehensive list of outcomes relevant to stakeholders will be compiled through systematic reviews and qualitative interviews with patients, families, and clinicians; (2) Delphi methodology will be applied to reduce the comprehensive list to a core outcome set; (3) we will review current clinical practice guidelines, existing clinical trials, and literature on bedside assessment of asthma severity. We will then identify practice differences in tne clinical assessment of asthma severity, and determine whether further prospective work is needed to achieve agreement on inclusion criteria for clinical trials in acute paediatric asthma in the emergency department (ED) setting; (4) a retrospective chart review in Australia and New Zealand will identify the incidence of serious clinical complications such as intubation, ICU admission, and death in children hospitalized with acute severe asthma. Understanding the incidence of such outcomes will allow us to understand how common (and therefore how feasible) particular outcomes are in asthma in the ED setting; and finally (5) a meeting of the Pediatric Emergency Research Networks (PERN) asthma working group will be held, with invitation of other clinicians interested in acute asthma research, and patients/families. The group will be asked to achieve consensus on a core set of outcomes and to make recommendations for the conduct of clinical trials in acute severe asthma. If this is not possible, the group will agree on a series of prioritized steps to achieve this aim.DiscussionThe development of an international consensus on core outcomes is an important first step towards the development of consensus guidelines and standardised protocols for randomized controlled trials (RCTs) in this population. This will enable us to better interpret and compare future studies, reduce risks of study heterogeneity and outcome reporting bias, and improve the evidence base for the management of this important condition

Additional file 2: of Development of metabolic and inflammatory mediator biomarker phenotyping for early diagnosis and triage of pediatric sepsis

Results of the metabolomic and protein mediator biomarker phenotyping in the two age subgroups. This file contains six figures depicting the results for the age subgroups and a seventh figure showing the loading plots that demonstrate which metabolites and/or inflammatory protein mediators contribute most to each component in the PCA models for the age 2–17-year-old cohort. (PDF 4020 kb

Additional file 1: of Test characteristics of common appendicitis scores with and without laboratory investigations: a prospective observational study

Published test characteristics for the Alvarado score, the Pediatric appendicitis score and the Lintula score used to calculate the sample size for the current study. Published test characteristics for the Alvarado score, the Pediatric appendicitis score and the Lintula score used to calculate the sample size for the current study [1, 4, 14–19]. (DOCX 16 kb