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

Abstract Background Acute 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/design A 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. Discussion The 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.

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PID https://www.doi.org/10.6084/m9.figshare.c.4816188
PID https://www.doi.org/10.6084/m9.figshare.c.4816188.v2
PID https://www.doi.org/10.6084/m9.figshare.c.4816188.v1
URL http://dx.doi.org/10.6084/m9.figshare.c.4816188.v2
URL http://dx.doi.org/10.6084/m9.figshare.c.4816188.v1
URL http://dx.doi.org/10.6084/m9.figshare.c.4816188
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Author Craig, Simon
Author Babl, Franz
Author Dalziel, Stuart
Author Gray, Charmaine
Author Powell, Colin
Author Ansari, Khalid
Author Lyttle, Mark
Author Roland, Damian
Author Benito, Javier
Author Velasco, Roberto
Author Hoeffe, Julia
Author Moldovan, Diana
Author Thompson, Graham
Author Schuh, Suzanne
Author Zorc, Joseph
Author Kwok, Maria
Author Mahajan, Prashant
Author Johnson, Michael
Author Sapien, Robert
Author Khanna, Kajal
Author Rino, Pedro
Author Prego, Javier
Author Yock, Adriana
Author Fernandes, Ricardo
Author Indumathy Santhanam
Author Cheema, Baljit
Author Ong, Gene
Author Chong, Shu-Ling
Author Graudins, Andis
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Collected From Datacite
Hosted By figshare
Publication Date 2020-01-01
Publisher figshare
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Language UNKNOWN
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keyword FOS: Biological sciences
keyword FOS: Health sciences
system:type other
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Source https://science-innovation-policy.openaire.eu/search/other?orpId=dedup_wf_001::1d860bf76d7e7e0fe33c2da03fe26059
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Last Updated 20 December 2020, 03:41 (CET)
Created 20 December 2020, 03:41 (CET)