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Management of asthma in childhood: study protocol of a systematic evidence update by the Paediatric Asthma in Real Life (PeARL) Think Tank

Management of asthma in childhood: study protocol of a systematic evidence update by the Paediatric Asthma in Real Life (PeARL) Think Tank
Management of asthma in childhood: study protocol of a systematic evidence update by the Paediatric Asthma in Real Life (PeARL) Think Tank

Introduction: clinical recommendations for childhood asthma are often based on data extrapolated from studies conducted in adults, despite significant differences in mechanisms and response to treatments. The Paediatric Asthma in Real Life (PeARL) Think Tank aspires to develop recommendations based on the best available evidence from studies in children. An overview of systematic reviews (SRs) on paediatric asthma maintenance management and an SR of treatments for acute asthma attacks in children, requiring an emergency presentation with/without hospital admission will be conducted. 

Methods and analysis: standard methodology recommended by Cochrane will be followed. Maintenance pharmacotherapy of childhood asthma will be evaluated in an overview of SRs published after 2005 and including clinical trials or real-life studies. For evaluating pharmacotherapy of acute asthma attacks leading to an emergency presentation with/without hospital admission, we opted to conduct de novo synthesis in the absence of adequate up-to-date published SRs. For the SR of acute asthma pharmacotherapy, we will consider eligible SRs, clinical trials or real-life studies without time restrictions. Our evidence updates will be based on broad searches of Pubmed/Medline and the Cochrane Library. We will use A MeaSurement Tool to Assess systematic Reviews, V.2, Cochrane risk of bias 2 and REal Life EVidence AssessmeNt Tool to evaluate the methodological quality of SRs, controlled clinical trials and real-life studies, respectively. Next, we will further assess interventions for acute severe asthma attacks with positive clinical results in meta-analyses. We will include both controlled clinical trials and observational studies and will assess their quality using the previously mentioned tools. We will employ random effect models for conducting meta-analyses, and Grading of Recommendations Assessment, Development and Evaluation methodology to assess certainty in the body of evidence. 

Ethics and dissemination: ethics approval is not required for SRs. Our findings will be published in peer reviewed journals and will inform clinical recommendations being developed by the PeARL Think Tank. PROSPERO registration numbers CRD42020132990, CRD42020171624.

asthma, paediatric thoracic medicine, paediatrics, thoracic medicine
2044-6055
e048338
Mathioudakis, Alexander G.
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Roberts, Graham
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PeARL collaborators, on behalf of the PeARL Think Tank
Mathioudakis, Alexander G.
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Miligkos, Michael
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Grigg, Jonathan
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Mathioudakis, Georgios A.
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Nagaraju, Karthik
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Roberts, Graham
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Turner, Stephen
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Xepapadaki, Paraskevi
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et al.,
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Mathioudakis, Alexander G., Miligkos, Michael, Boccabella, Cristina, Alimani, Gioulinta S., Custovic, Adnan, Deschildre, A. and et al., , PeARL collaborators, on behalf of the PeARL Think Tank (2021) Management of asthma in childhood: study protocol of a systematic evidence update by the Paediatric Asthma in Real Life (PeARL) Think Tank. BMJ Open, 11 (7), e048338, [e048338]. (doi:10.1136/bmjopen-2020-048338).

Record type: Article

Abstract

Introduction: clinical recommendations for childhood asthma are often based on data extrapolated from studies conducted in adults, despite significant differences in mechanisms and response to treatments. The Paediatric Asthma in Real Life (PeARL) Think Tank aspires to develop recommendations based on the best available evidence from studies in children. An overview of systematic reviews (SRs) on paediatric asthma maintenance management and an SR of treatments for acute asthma attacks in children, requiring an emergency presentation with/without hospital admission will be conducted. 

Methods and analysis: standard methodology recommended by Cochrane will be followed. Maintenance pharmacotherapy of childhood asthma will be evaluated in an overview of SRs published after 2005 and including clinical trials or real-life studies. For evaluating pharmacotherapy of acute asthma attacks leading to an emergency presentation with/without hospital admission, we opted to conduct de novo synthesis in the absence of adequate up-to-date published SRs. For the SR of acute asthma pharmacotherapy, we will consider eligible SRs, clinical trials or real-life studies without time restrictions. Our evidence updates will be based on broad searches of Pubmed/Medline and the Cochrane Library. We will use A MeaSurement Tool to Assess systematic Reviews, V.2, Cochrane risk of bias 2 and REal Life EVidence AssessmeNt Tool to evaluate the methodological quality of SRs, controlled clinical trials and real-life studies, respectively. Next, we will further assess interventions for acute severe asthma attacks with positive clinical results in meta-analyses. We will include both controlled clinical trials and observational studies and will assess their quality using the previously mentioned tools. We will employ random effect models for conducting meta-analyses, and Grading of Recommendations Assessment, Development and Evaluation methodology to assess certainty in the body of evidence. 

Ethics and dissemination: ethics approval is not required for SRs. Our findings will be published in peer reviewed journals and will inform clinical recommendations being developed by the PeARL Think Tank. PROSPERO registration numbers CRD42020132990, CRD42020171624.

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Accepted/In Press date: 1 June 2021
Published date: 2 July 2021
Additional Information: Funding Information: Acknowledgements AGM was supported by the National Institute of Health Research Manchester Biomedical Research Centre (NIHR Manchester BRC). We thank Mrs Maria Kritikou for excellent administrative support of the study Contributors Study conception: AGM and NGP. Study design: AGM, MM and NGP. Preparation of the manuscript: AGM. Critical revision and final approval of the manuscript: AGM, MM, CB, GSA, AC, AD, FMD, OK, CM, ANG, WP, DP, AS, IOA, LB, AB, AB, MB, JAC-R, GDC, TC, ZD, WF, TF, JEG, JG, GH, EMH, DI, TJ, AK, RFL, PNLS, MJM, GAM, PM, MM, MM-A, KN, EP, HP, PMCP, PP, GR, IT, ST, VS, TAW, GWKW, PX, HJZ and NGP. Funding This work was supported by the Respiratory Effectiveness Group (REG). REG has received support from AstraZeneca, Novartis and Sanofi for continued work on PeARL. (Award/Grant name: PeARL, Award/Grant Number: N/A). This is an investigator initiated study and the funders were not involved in the selection of the topic, or design of these systematic reviews. AGM was supported by the National Institute for Health Research Manchester Biomedical Research Centre (NIHR Manchester BRC). Funding Information: Competing interests AGM reports grants from Boehringer Ingelheim outside the submitted work. AC reports personal fees from Novartis, Regeneron / Sanofi, Thermo Fisher Scientific, Boehringer Ingelheim and Philips, outside the submitted work. LB reports personal fees from Aerocrine, GlaxoSmithKline, Genentech/ Novartis, Merck, DBV Technologies, Teva, Boehringer Ingelheim, AstraZeneca, WebMD/Medscape, Sanofi/Regeneron, Vectura and Circassia outside the submitted work. TC reports grants and personal fees CSL Behring, Dyax, Takeda, BioCryst, Pharming, personal fees from Grifols, grants and non-financial support from GSK, Regeneron, Novartis/Genetech outside the submitted work. AD reports grants and personal fees from Stallergenes Greer, personal fees from Novartis, ALK, TEVA, GSK, MEDA-MYLAN, CHIESI, AImmune, DBV technologies and Astra Zeneca, outside the submitted work. ZD reports personal fees from academic affiliations, ZD acts as Executive and Scientific Medical Director at a phase I/II pharmacological unit (QPS-NL), which performs clinical studies for pharmaceutical companies. ZD reports personal fees from Astrazeneca, ALK, Aquilon, Boehringer Ingelheim, CSL, HAL Allergy, MSD, and Sanofi-Genzyme outside the submitted work. FMD reports grants from Thorasys; personal fees from Jean-Coutu Pharmaceuticals, unrestricted research funds from Novartis Canada, Teva and Trudell Medical, research grants from GlaxoSmithKline and MEDteq in partnership with Thorasys; honorarium for consultancy work from Covis Pharma and Teva; and honorarium as invited speaker from Covis Pharma, Pharmacy Brunet, outside the submitted work. JEG reports grants from NIH/NIAID, personal fees from Regeneron, Ena Theraputics and MedImmune outside the submitted work; personal fees and stock options from Meissa Vaccines Inc outside the submitted work. JG reports personal fees from GSK, Vifor Pharmaceuticals, Novartis, BV Pharma and AstraZeneca outside the submitted work. AK reports personal fees Astra Zeneca, Behring, Boehringer Ingelheim, Covis, GSK, NovoNordisk, Novartis, Griffols, Pfizer, Sanofi, Teva and Trudel, outside the submitted work. RFL reports grants from NIH, non-financial support from GlaxoSmithKline, Boehringer-Ingelheim, Merck, TEVA, American Academy of Allergy, Asthma and Immunology, grants from Clinical and Translational Science Award (NIH), Childhood Origins of ASThma (COAST) grant, AsthmaNet, personal fees from LSU, Elsevier, UpToDate, the University of Kentucky, ThermoFischer, and Food Allergy Research and Education (FARE) Network, outside the submitted work. CM reports personal fees from Novartis, GSK, Astra Zeneca, Thermo Fisher and Boehringer Ingelheim outside the submitted work. NGP reports personal fees from ALK, Novartis, Nutricia, HAL, Menarini/FAES Farma, Sanofi, Mylan/MEDA, Biomay, AstraZeneca, GSK, MSD, ASIT BIOTECH and Boehringer Ingelheim; grants from Gerolymatos International SA and Capricare outside the submitted work. WP reports grants from NIH; grants and personal fees from Genentech/Novartis, Sanofi/Rgeneron; personal fees GSK; non-financial support from Thermo Fisher, Lincoln Diagnostics, Alk Abello, and Monaghen, outside the submitted work. PP reports grants from Astra Zeneca, Chiesi and TEVA; personal fees from Astra Zeneca, TEVA, Novartis, Mundipharma, S&D Pharma, and GlaxoSmithKline outside the submitted work. DP reports grants from AKL Research and Development, British Lung Foundation, Respiratory Effectiveness Group and the UK National Health Service; grants and personal fees from Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Napp, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, TEVA, Theravance and Zentiva (Sanofi Generics); personal fees from Cipla, GlaxoSmithKline, Kyorin and Merck; non-financial support from Efficacy and Mechanism Evaluation programme, Health Technology Assessment, outside the submitted work; DP also reports stock/stock options from AKL Research and Development which produces phytopharmaceuticals; and owns 74% of the social enterprise Optimum Patient Care (Australia and UK) and 74% of Observational and Pragmatic Research Institute (Singapore), outside the submitted work. GR reports personal fees from ALK, Allergen Therapeutics, Meda Plus, Merck; and a patent for the use of sublingual immunotherapy to prevent the development of allergy in at-risk infants, outside the submitted work. IT reports personal fees from Novartis, GSK, Boehringer Ingelheim and Astra Zeneca; grants from GSK Hellas, outside the submitted work. PX reports personal fees from Nutricia, Nestle, Friesland, Uriach, Novartis Pharma AG, and GlaxoSmithkline outside the submitted work. Publisher Copyright: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
Keywords: asthma, paediatric thoracic medicine, paediatrics, thoracic medicine

Identifiers

Local EPrints ID: 452153
URI: http://eprints.soton.ac.uk/id/eprint/452153
ISSN: 2044-6055
PURE UUID: 90eb1a26-82ca-42e7-afb6-9c434880bdb8
ORCID for Graham Roberts: ORCID iD orcid.org/0000-0003-2252-1248

Catalogue record

Date deposited: 25 Nov 2021 21:50
Last modified: 18 Mar 2024 03:01

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Contributors

Author: Alexander G. Mathioudakis
Author: Michael Miligkos
Author: Cristina Boccabella
Author: Gioulinta S. Alimani
Author: Adnan Custovic
Author: A. Deschildre
Author: Francine Monique Ducharme
Author: Omer Kalayci
Author: Clare Murray
Author: Antonio Nieto Garcia
Author: Wanda Phipatanakul
Author: David Price
Author: Aziz Sheikh
Author: Ioana Octavia Agache
Author: Leonard Bacharier
Author: Apostolos Beloukas
Author: Andrew Bentley
Author: Matteo Bonini
Author: Jose A. Castro-Rodriguez
Author: Giuseppe De Carlo
Author: Timothy Craig
Author: Zuzana Diamant
Author: Wojciech Feleszko
Author: Tim Felton
Author: James E. Gern
Author: Jonathan Grigg
Author: Gunilla Hedlin
Author: Elham M. Hossny
Author: Despo Ierodiakonou
Author: Tuomas Jartti
Author: Alan Kaplan
Author: Robert F. Lemanske
Author: Peter N. Le Souëf
Author: Mika J. Mäkelä
Author: Georgios A. Mathioudakis
Author: Paolo Matricardi
Author: Marina Mitrogiorgou
Author: Mario Morais-Almeida
Author: Karthik Nagaraju
Author: Effie Papageorgiou
Author: Helena Pité
Author: Paulo M.C. Pitrez
Author: Petr Pohunek
Author: Graham Roberts ORCID iD
Author: Ioanna Tsiligianni
Author: Stephen Turner
Author: Susanne Vijverberg
Author: Tonya A. Winders
Author: Gary W.K. Wong
Author: Paraskevi Xepapadaki
Author: et al.
Corporate Author: PeARL collaborators, on behalf of the PeARL Think Tank

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