Clinimetric Properties of Outcome Measures in Bronchiectasis in the UK

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 BronchUK 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 (Smith and Hill, 2012) 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).

AIM

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. Our specific questions are which outcome measures are most stable in bronchiectasis over time; and, which outcome measures demonstrate the biggest effect size over a pulmonary exacerbation signal interval?

METHODS

Participants will have four visits scheduled four months apart over the period of one year. During each visit assessments will be taken to assess: lung function (spirometry, lung clearance index); health related quality of life (HRQoL) [Quality of Life-Bronchiectasis (QOL-B) Questionnaire; the Respiratory and Systemic Systems Questionnaire (RSSQ); Leicester Cough Questionnaire (LCQ); St Georges Respiratory Questionnaire (SGRQ)]; and, blood (white cell count, c-reactive protein) and sputum (microbiology, inflammatory markers) processing. At all visits height, weight and vital signs will be recorded (to include: temperature, pulse, respiratory rate, SpO₂ and blood pressure). In addition, a pregnancy test will be done with any female participants in whom pregnancy cannot be excluded.

Additionally, if the participant develops a pulmonary exacerbation during the one year period two further visits will be performed one at the commencement of the episode and one at the end.

SITES INVOLVED

This is a UK study and the research is being conducted within the hospital setting. In Northern Ireland the majority of visits will be conducted at the Belfast City Hospital or if more convenient (e.g. at the start or end of an exacerbation) at the relevant hospital site. In Wales participants will attend University Hospital Llandough; in Scotland the Royal Infirmary of Edinburgh, or Ninewells Hospital; and, in England, Papworth Hospital, University Hospital Southampton, or Royal Brompton Hospital.

OUTPUT

To provide data on the clinimetric properties of a range of outcome measures and make recommendations for their use in clinical trials in bronchiectasis. It is planned to publish data from this study in peer review articles and to present data at national and international meetings.

CONTACT DETAILS

If interested please contact your local site using the details in the table below.

Alternatively please contact:

Kathryn McDowell, Study Co-ordinator, Lead Site

NI Clinical Research Network (Respiratory Health Group), NICRN Respiratory Research Office, Belfast City Hospital, 51 Lisburn Road, Belfast, BT9 7AB

Phone: 028 95 043876

Email: kathryn.mcdowell@belfasttrust.hscni.net

Updates:

January 2016

• The Clinimetrics study is open and recruiting. 
• Royal Brompton Hospital, Belfast City Hospital and Southampton General Hospital are qualified in MBW and have EcoMedics machines on site. Other sites in set up.

Clinimetrics newsletters:

Download BronchUKClinimetrics Newsletter 2 (003) (390KB)

Download BronchUKClinimetrics Newsletter 1 (003) (406KB)