Core Outcome Measures in Effectiveness Trials

Development of a core outcome set (COS) for the management of acute exacerbations of chronic obstructive pulmonary disease in clinical research and practice. The COS-AECOPD study.

General Information

Summary:
Background: Clinical research studies, including randomised controlled trials (RCTs) evaluating the management of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) evaluate and report heterogeneous outcome measures. This complicates comparing, synthesising and interpreting their results.

Objectives: This project aims to develop a globally representative core outcome set (COS) for AECOPD management that will extend beyond RCTs, to any clinical study evaluating the management of AECOPD, as well as clinical practice.

Study design and methods: For the development of this COS, we will follow standard methodology suggested by the COMET initiative, the COS-STAD and COS-STAR documents. The study protocol will be prospectively registered in the COMET database. First, we will conduct qualitative research aiming to elicit outcome measures that are considered relevant to AECOPD, by patients with COPD and their caregivers. Starting from the outcomes identified by extensive systematic reviews of the literature and our qualitative studies, we will undertake an extensive Delphi survey to prioritise the most important outcomes that will be included in the COS. Our Delphi will capture independently the views of COPD patients and their carers, clinicians and clinical researchers, and other relevant stakeholders. Our aim is for this survey to have an international reach, including high- and low-income countries. Finally, we will conduct a consensus meeting, involving representatives of all relevant stakeholders, to finalise the COS.

Contributors:
Chief Investigator:
Prof. Jørgen Vestbo DMSc, FRCP, FERS, FMedSci,
Professor of Respiratory Medicine, Manchester University NHS Foundation Trust and The University of Manchester.

Co-Investigators:
Dr. Alexander G. Mathioudakis MD, MRCP(UK)
Clinical Research Fellow and Honorary Lecturer in Respiratory Medicine, Manchester University NHS Foundation Trust and The University of Manchester.

Prof. Paula Williamson BSc, PhD
Professor of Medical Statistic, University of Liverpool.

Prof. Janelle Yorke PhD, Mres, Post Grad Dip, PGCE, RN
Professor of Nursing, The University of Manchester.

Miss Olivia Joseph
Public Programmes Project Manager, NIHR Manchester BRC.

Further Study Information

Current Stage:
Planning
Date:
May 2019 - November 2020
Funding source(s):
This study will be supported by the NIHR Manchester Biomerdical Research Centre (BRC)

Health Area

Disease Category
Lungs & airways

Disease Name
Chronic obstructive pulmonary disease (COPD)

Target Population

Age Range
40 - 99

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Systematic review

For the development of this COS, we will follow standard methodology suggested by the COMET initiative, the COS-STAD and COS-STAR documents. The study protocol will be prospectively registered in the COMET database. We have already conducted a methodological systematic review exploring the outcomes measured and reported by clinical trials and systematic reviews on COPD exacerbations management during the last decade. Next, we will conduct qualitative research (focus groups) aiming to elicit outcome measures that are considered relevant to AECOPD, by patients with COPD and their caregivers. Starting from the outcomes identified by extensive systematic reviews of the literature and our qualitative studies, we will undertake an extensive Delphi survey to prioritise the most important outcomes that will be included in the COS. Our Delphi will capture independently the views of COPD patients and their carers, clinicians and clinical researchers, and other relevant stakeholders. Our aim is for this survey to have an international reach, including high- and low-income countries. Finally, we will conduct a consensus meeting, involving representatives of all relevant stakeholders, to finalise the COS.


Stakeholders Involved

Charities
Clinical experts
Consumers (caregivers)
Consumers (patients)
Epidemiologists
Families
Governmental agencies
Methodologists
Patient/ support group representatives
Pharmaceutical industry representatives
Policy makers
Regulatory agency representatives
Researchers
Service providers
Service users
Statisticians

Study Type

COS for clinical trials or clinical research
COS for practice

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