Format

Send to

Choose Destination
Trials. 2020 Jan 13;21(1):72. doi: 10.1186/s13063-019-3785-6.

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

Craig S1,2, Babl FE3,4,5,6, Dalziel SR6,7,8, Gray C6,9,10, Powell C11,12,13, Al Ansari K11,13, Lyttle MD14,15,16, Roland D16,17,18, Benito J19,20,21, Velasco R21,22, Hoeffe J23,24,25, Moldovan D25,26, Thompson G27,28,29, Schuh S29,30,31,32, Zorc JJ33,34, Kwok M35,36, Mahajan P37,38, Johnson MD36,39, Sapien R36,40, Khanna K41,42,43, Rino P44,45,46, Prego J46,47, Yock A46,48, Fernandes RM49,50, Santhanam I51, Cheema B52,53, Ong G54,55, Chong SL54,55, Graudins A56,6,57; Pediatric Emergency Research Networks (PERN).

Author information

1
Paediatric Emergency Department, Monash Medical Centre, 246 Clayton Rd, Clayton, Victoria, 3168, Australia. Simon.craig@monash.edu.
2
Department of Paediatrics, School of Clinical Sciences at Monash Health, Monash University, Clayton, Australia. Simon.craig@monash.edu.
3
Emergency Department, Royal Children's Hospital, Melbourne, Australia.
4
Department of Paediatrics, University of Melbourne, Melbourne, Australia.
5
Murdoch Children's Research Institute, Melbourne, Australia.
6
Paediatric Research in Emergency Departments International Collaborative (PREDICT) Network, Melbourne, Australia.
7
Starship Children's Hospital, Auckland, New Zealand.
8
Liggins Institute, University of Auckland, Auckland, New Zealand.
9
Women's & Children's Hospital, Adelaide, Australia.
10
University of Adelaide, Adelaide, Australia.
11
Emergency Department, Sidra Medicine, Doha, Qatar.
12
School of Medicine, Cardiff University, Cardiff, UK.
13
Pediatric Emergency Research Qatar (PERQ) Network, ., Qatar.
14
Bristol Royal Hospital for Children, Bristol, UK.
15
Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.
16
Paediatric Emergency Research in the United Kingdom and Ireland (PERUKI), ., UK.
17
SAPPHIRE Group, Health Sciences, Leicester University, Leicester, UK.
18
Paediatric Emergency Medicine Leicester Academic (PEMLA) Group, Children's Emergency Department, Leicester Royal Infirmary, Leicester, UK.
19
Pediatric Emergency Department, Cruces University Hospital, Bilbao, Spain.
20
Department of Pediatrics, Basque Country University, San Sebastian, Spain.
21
Red de Investigación SEUP (Sociedad Española de Urgencias Pediátricas) Network, Madrid, Spain.
22
Pediatric Emergency Unit, Hospital Universitario Río Hortega, Valladolid, Spain.
23
University of Switzerland, ., Switzerland.
24
Inselspital, University Hospital of Berne, Berne, Switzerland.
25
Research in European Pediatric Emergency Medicine (REPEM) Network, Leicester, UK.
26
Emergency Department, Tirgu Mures Emergency Clinical County Hospital, Targu Mures, Romania.
27
Alberta Children's Hospital Research Institute, Calgary, AB, Canada.
28
Departments of Pediatrics and Emergency Medicine, University of Calgary, Calgary, AB, Canada.
29
Pediatric Emergency Research Canada (PERC) Network, Calgary, Alberta, Canada.
30
Division of Pediatric Emergency Medicine, Hospital for Sick Children, Toronto, Canada.
31
SickKids Research Institute, Toronto, Canada.
32
University of Toronto, Toronto, Canada.
33
Division of Emergency Medicine, Children's Hospital of Philadelphia, Philadelphia, PA, USA.
34
Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
35
Columbia University Medical Center, New York, USA.
36
Pediatric Emergency Care Applied Research Network (PECARN), New York, USA.
37
Department of Emergency Medicine and Pediatrics, University of Michigan, Ann Arbor, MI, USA.
38
Pediatric Care Applied Research Network (PECARN), Utah, USA.
39
University of Utah, Utah, USA.
40
University of New Mexico, Albuquerque, NM, USA.
41
Department of Emergency Medicine, Stanford University, Stanford, CA, USA.
42
Global Pediatric Emergency Equity Lab at Stanford University, Stanford CA, USA.
43
Pediatric Emergency Medicine Collaborative Research Committee (PEMCRC), Itasca, Illinois, USA.
44
Hospital de Pediatría "Prof. Dr. Juan P. Garrahan", Buenos Aries, Argentina.
45
Universidad de Buenos Aires, Buenos Aries, Argentina.
46
Red de Investigación y Desarrollo de la Emergencia Pediátrica Latinoamericana (RIDEPLA), Leicester, UK.
47
Centro Hospitalario Pereira Rossell de Montevideo, Montevideo, Uruguay.
48
Hospital Nacional de Niños "Dr. Carlos Saenz Herrera", San José, Costa Rica.
49
Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Lisbon, Portugal.
50
Laboratório de Farmacologia Clinica e Terapêutica, Faculdade de Medicina, Instituto de Medicina Molecular, Universidade de Lisboa, Lisbon, Portugal.
51
Madras Medical College, Chennai, India.
52
Emergency Medical Services, Western Cape Health, Belville, South Africa.
53
Division of Emergency Medicine, University of Cape Town, Cape Town, South Africa.
54
KK Women's and Children's Hospital, Singapore, Singapore.
55
Duke-NUS Medical School, Singapore, Singapore.
56
Department of Paediatrics, School of Clinical Sciences at Monash Health, Monash University, Clayton, Australia.
57
Emergency Medicine Service, Monash Health, Melbourne, Australia.

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.

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center