Core Outcome Measures in Effectiveness Trials

Non-invasive ventilation for the management of children with bronchiolitis (NOVEMBR): A feasibility and COS development study

General Information

Summary:
Background
Bronchiolitis is an acute lower respiratory infection which affects young children. There are currently no treatment interventions only supportive therapy. Nasal oxygen therapy is part of routine care and delivery now incorporates varying levels of positive airway pressure and/or high flows. Despite wide clinical use there remains a lack of evidence.

Aims
The long term aim of the NOVEMBR feasibility study is to find out how to best provide respiratory support to children with bronchiolitis.
The primary aims are to:

1. Develop a core outcome set (COS) for use in future clinical trials
2. Explore issues critical to RCT study design of non-invasive ventilation
3. Comprehensively assess current UK bronchiolitis management and potential trial capability and acceptability

Methods
This is a mixed methods study which includes: systematic review, focus group workshops with important stakeholders (health care professionals (n=80) and parents (n=20), parent telephone interviews (n=15) and a Delphi survey (n<340). These methods will be undertaken to identify and prioritise important outcomes for inclusion into a COS and to explore important issues which will inform the design of a future randomised control trial. UK hospitals will be contacted and asked to complete a survey to provide an overview of current practice to enable assessment of capability and capacity to run a future clinical trial.

Discussion
This study will facilitate future RCT design that is acceptable to important stakeholders. Furthermore, COS development will improve standardisation, measurement and reporting of outcomes.

Contributors:
Clare van Miert(1,2), Ricardo M Fernandes(3,4), Helen Eccleson(5),
Emma Bedson(5), Steven Lane(6), Matthew Peak(2), Kent Thorburn(2), Vanessa Compton(2), Kerry Woolfall(7), David Lacy(8), Paula Williamson(9), Paul.S.McNamara (2,10)

Chief investigator Paul.S.McNamara; Principle Investigator Clare van Miert

1.School of Nursing and Allied Health, Room 3.12 Henry Cotton Building, Liverpool John Moores University, 15-21 Webster Street, Liverpool, L3 2ET. UK

2.Alder Hey Children’s NHS Foundation Hospital Trust, Eaton Road, Liverpool, L12 2AP. UK

3.Clinical Pharmacology Lab/Unit, Faculty of Medicine and Instituto de Medicina Molecular, Universidade de Lisboa

4.Department of Pediatrics, Hospital Santa Maria, Lisboa

5.Medicines for Children Clinical Trials Unit, Clinical Trials Research Centre, University of Liverpool, Institute of Child Health, Alder Hey Children's NHS Foundation Trust. Liverpool, L12 2AP

6.Department of biostatistics, Block F, Waterhouse Building, 1-5 Brownlow Street, Liverpool L69 3GL. UK

7.MRC North West Hub for Trials Methodology Research Institute of Psychology, Health and Society, Block B, Room B112, 1st Floor Waterhouse Building, Liverpool L69 3GL. UK

8.Department of Paediatrics, Wirral University Teaching Hospital NHS Foundation Trust, Arrowe Park Road, Upton, Wirral, CH49 5PE. UK

9.MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, 1st floor Duncan Building, Daulby Street, Liverpool L69 3GA, UK.

10.Institute of Child Health, University of Liverpool, Alder Hey Children’s NHS Foundation Trust, Eaton Road, Liverpool, L12 2AP.UK

Further Study Information

Current Stage:
Planning
Date:
February 2016 - August 2018
Funding source(s):
NIHR Research for Patient Benefit

Health Area

Disease Category
Child health

Disease Name
Bronchiolitis

Target Population

Age Range
0 - 2

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Interview
Semi structured discussion
Survey
Systematic review

Stakeholders Involved

Clinical experts
Consumers (caregivers)
Families

Study Type

COS for clinical trials or clinical research
COS for practice

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