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

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dc.contributor.authorCraig, Simon
dc.contributor.authorBabl, Franz E.
dc.contributor.authorDalziel, Stuart R.
dc.contributor.authorGray, Charmaine
dc.contributor.authorPowell, Colin
dc.contributor.authorAl Ansari, Khalid
dc.contributor.authorLyttle, Mark D.
dc.contributor.authorRoland, Damian
dc.contributor.authorBenito, Javier
dc.contributor.authorVelasco, Roberto
dc.contributor.authorHoeffe, Julia
dc.contributor.authorMoldovan, Diana
dc.contributor.authorThompson, Graham
dc.contributor.authorSchuh, Suzanne
dc.contributor.authorZorc, Joseph J.
dc.contributor.authorKwok, Maria
dc.contributor.authorMahajan, Prashant
dc.contributor.authorJohnson, Michael D.
dc.contributor.authorSapien, Robert
dc.contributor.authorKhanna, Kajal
dc.contributor.authorRino, Pedro
dc.contributor.authorPrego, Javier
dc.contributor.authorYock, Adriana
dc.contributor.authorFernandes, Ricardo M.
dc.contributor.authorSanthanam, Indumathy
dc.contributor.authorCheema, Baljit
dc.contributor.authorOng, Gene
dc.contributor.authorChong, Shu-Ling
dc.contributor.authorGraudins, Andis
dc.date.accessioned2022-09-07T13:44:15Z
dc.date.available2022-09-07T13:44:15Z
dc.date.issued2020
dc.description© The Author(s). 2020 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.pt_PT
dc.description.abstractBackground: 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.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationTrials. 2020 Jan 13;21(1):72pt_PT
dc.identifier.doi10.1186/s13063-019-3785-6pt_PT
dc.identifier.eissn1745-6215
dc.identifier.urihttp://hdl.handle.net/10451/54353
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherSpringer Naturept_PT
dc.relation.publisherversionhttps://trialsjournal.biomedcentral.com/pt_PT
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/pt_PT
dc.titleAcute severe paediatric asthma: study protocol for the development of a core outcome set, a Pediatric Emergency Research Networks (PERN) studypt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue1pt_PT
oaire.citation.titleTrialspt_PT
oaire.citation.volume21pt_PT
person.familyNameFernandes
person.givenNameRicardo
person.identifier309018
person.identifier.orcid0000-0002-7253-6475
person.identifier.ridC-7501-2015
person.identifier.scopus-author-id24436565500
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublication862be38f-2247-424c-b26c-d3bdda4474be
relation.isAuthorOfPublication.latestForDiscovery862be38f-2247-424c-b26c-d3bdda4474be

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