Depression Clinical Trial
Official title:
Modelling of Quality Life, Clinical and Physiological Measures in Idiopathic Pulmonary Fibrosis
As there are no validated tools for assessing patient reported outcomes or health related quality of life in idiopathic pulmonary fibrosis (IPF), different studies have utilised different methods. This means that comparison of the outcomes of studies is difficult or inaccurate. By collecting different quality of life tools and patient reported outcome at the same time, it will be possible to map or model the results of one tool or groups of tools onto another. 250 patients with IPF will be asked to complete the EuroQoL 5D, Kings Brief Interstitial Lung Disease questionnaire, St George's Respiratory Questionnaire, MRC dyspnoea scale, University of California, San Diego shortness of breath questionnaire and the Hospital Anxiety and Depression Scale, along with spirometry every 3 months, and undergo a 6 minute walk test every 6 months, over a 12 month period. Prognostic models will be constructed from all the clinical (questionnaire and function) measures a linear regression model.
There are no validated or accepted tools for assessing health related quality of life
(HRQOL) or dyspnoea in patients with idiopathic pulmonary fibrosis (IPF) and there are no
accepted or recommended tools for assessing patient reported outcomes in clinical trials of
patients with IPF. Assessment of these outcomes is important to patients and may be
considered the most crucial outcome measures of an intervention in IPF. With this in mind,
the majority of the recently reported randomised clinical studies in IPF have evaluated
HRQOL and dyspnoea, most commonly as secondary outcomes, but this has been achieved by
different tools. For example the Capacity studies(1) utilised the St George's Respiratory
Questionnaire whereas the ASCEND (Efficacy and Safety of Pirfenidone in Patients With
Idiopathic Pulmonary Fibrosis) (http://clinicaltrial.gov/ct2/show/NCT01366209) study is
currently assessing dyspnoea using the University of California, San Diego shortness of
breath questionnaire. As there is no method of directly comparing HRQOL between different
clinical evaluations in IPF, there is a desperate need to produce algorithms for relating
the different outcome measures in IPF.
The St George's Respiratory Questionnaire(2) is the most commonly utilised tool in trials of
IPF(3-5). Although it relates to physiological impairment in IPF(6), it was developed in
patients with Chronic Obstructive Pulmonary Disease (COPD) and therefore lacks content
validity. An abbreviated version (SGRQ-I) containing the questions most relevant to IPF has
therefore been developed and validated(7). The Kings Brief Interstitial Lung disease
(K-BILD) questionnaire is a recently validated tool for patients with interstitial lung
disease not specifically idiopathic pulmonary fibrosis(8) but has not been utilised in
multicentre studies to measure treatment interventions in IPF. The EuroQol 5D (EQ5D) is a
well-validated global health status instrument designed for use in clinical and
health-economic trials(9). This has been validated in chronic respiratory disease and has
been used in several studies(4, 5, 10). In terms of assessing dyspnoea, studies have
utilised the University of California, San Diego (UCSD) shortness of breath questionnaire
(SOBQ)(4, 11), the medicine research council (MRC) dyspnoea score(5), and the transition
dyspnoea index(12).
The investigators have conducted a brief mapping exercise based on the data from patients
randomised to the placebo arm of the Treating idiopathic pulmonary fibrosis with the
addition of co-trimoxazole (TIPAC) study(5). The SGRQ data were mapped onto the EQ5D data
using pairs of data from individuals at the same time point with the addition demographic
and lung function data(unpublished). This mapping exercise produced an equation with greater
predictive strength than using data from COPD patients showing that modelling algorithms are
disease specific information cannot be shared between different respiratory conditions. The
investigators now wish to undertake a larger study to generate more accurate models to
approximate the EQ5D and also to explore the relationship between other patient reported
outcome measures. It is only by undertaking this work, that the results of individual
studies can be compared.
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