Core Outcome Measures in Effectiveness Trials

Core Outcome Measures in Bloodstream infection Antimicrobial Trials (COMBAT) in children

General Information

Summary:
Bloodstream infections (BSI) are associated with significant mortality and morbidity in children. In an age of increasing antimicrobial resistance, understanding the most appropriate treatment of BSI is essential. Antimicrobial trials are rarely conducted in children and are limited by lack of standardised outcome measures. To facilitate harmonised outcome reporting in antimicrobial trials of BSI in children, we aim to develop a modified Delphi process to achieve a core outcome set.

Contributors:
Dr Adam Irwin, The University of Queensland Centre for Clinical Research and Queensland Children's Hospital. Principal Investigator.
Dr Sophie Wen, The University of Queensland and Queensland Children's Hospital.
Lars Eriksson, The University of Queensland.
Associate Professor Julia Clark, Queensland Children's Hospital.
Dr Anita Campbell, Perth Children's Hospital and University of Western Australia.
Dr Asha Bowen, Perth Children's Hospital and University of Western Australia.
Associate Professor Chris Blyth, Perth Children's Hospital and University of Western Australia.
Dr Patrick Harris, The University of Queensland Centre for Clinical Research.
Associate Professor Luregn Schlapbach, The University of Queensland and Queensland Children's Hospital.
Professor Henry Chambers, University of California San Francisco.
Professor David Paterson, The University of Queensland Centre for Clinical Research.

Further Study Information

Current Stage:
Ongoing
Date:
January 2019 - June 2020
Funding source(s):
None

Health Area

Disease Category
Infectious disease

Disease Name
Bloodstream infections

Target Population

Age Range
0 - 18

Sex
Either


Nature / type of Intervention
Other

Method(s)

Delphi process
Interview
Literature review
Systematic review

Mixed-methods design. Researchers will be invited to participate in a modified Delphi process using a web-based survey. Initial rounds of the survey will be informed by the results of patient and carer interviews, and a systematic review of existing evidence.

A scoping review of prospective studies of outcomes reported in studies of bloodstream infection in children. The review will follow an established methodology and be reported in line with the PRISMA statement.

Patient and carer interviews will be undertaken at Queensland Children’s Hospital. Interviews will be narrative based and analysed with the support of qualitative researchers at the University of Queensland. A total of 8-12 narrative interviews will be undertaken with particular representation from paediatric haemato-oncology, intensive care and neonatology. Ethics approval will be sought from the Children’s Health Queensland Research Ethics Committee.

Researchers and clinicians in infectious diseases, paediatrics, microbiology, critical care, health economics and trials methodology will be invited to participate in a modified Delphi process to achieve consensus on the contents of core outcome measures for clinical trials of paediatric BSI. Based on recent work undertaken at the University of Queensland, it is anticipated that different core outcome measures will be established for BSI caused by Gram-negative organisms and Staphylococcus aureus.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Families
Methodologists
Patient/ support group representatives
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice

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