Clinimetric Properties of Outcome Measures in Bronchiectasis in the UK

Summary

There is an increasing demand for researchers and regulatory bodies to use robust outcome measures in clinical trials which have evidence of validity, reliability, and responsiveness. There is currently little agreement on the core clinical endpoints that should be used in bronchiectasis. The importance of improving endpoint outcome measurement is well recognised and groups in other conditions have focused on activities to achieve consensus on a core set of outcomes for clinical trials. The Bronch-UK collaboration has explored the current evidence for clinimetric properties of commonly used outcome measures in bronchiectasis (e.g. forced expiratory volume in one second \[FEV1\], health related quality of life \[HRQoL\], and pulmonary exacerbations). The results of this extensive rigorous literature review of 68 papers clearly demonstrate that whilst there was good evidence for validity for key outcome measures in bronchiectasis there is little information available on their reliability (during periods of clinical stability) or response to treatment (effect sizes).

The aim of this study is to explore the clinimetric properties of a range of outcome measures, in order to make recommendations for their use in clinical trials in bronchiectasis.

Conditions

• Bronchiectasis

Sponsors & Collaborators

• Belfast Health and Social Care Trust

  collaborator OTHER

• South Eastern Health and Social Care Trust

  collaborator OTHER

• Royal Brompton & Harefield NHS Foundation Trust

  collaborator OTHER

• NHS Lothian

  collaborator OTHER_GOV

• Papworth Hospital NHS Foundation Trust

  collaborator OTHER_GOV

• NHS Tayside

  collaborator OTHER_GOV

• University Hospital Southampton NHS Foundation Trust

  collaborator OTHER

• Cardiff and Vale University Health Board

  collaborator OTHER_GOV

• Medical Research Council

  collaborator OTHER_GOV

• Queen's University, Belfast

  lead OTHER

Principal Investigators

• Judy M Bradley, PhD · Belfast Health and Social Care Trust

• Michael Loebinger, MD · Royal Brompton and Harefield Trust

• Stephen Rowan, MD · South Eastern Health and Social Care Trust

• Adam Hill, MD · NHS Lothian

• Charles Haworth, MD · Papworth Hospital NHS Foundation Trust

• James Chalmers, MD · NHS Tayside

• Mary Carroll, MD · University Hospital Southampton NHS Foundation Trust

• James Duckers, MD · Cardiff and Vale University Health Board

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-31

Primary Completion

2018-05-31

Completion

2019-07-31

Countries

• United Kingdom

Study Locations