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Clinically important differences in the intensity of chronic refractory breathlessness
Miriam J Johnson1, J Martin Bland, Stephen G Oxberry
1Palliative Medicine, Hull York Medical School, University of Hull, Hull, United Kingdom.
Journal of Pain and Symptom Management
|April 24, 2013
Summary
A clinically important difference in breathlessness is estimated at 10mm. This finding helps in designing clinical trials for chronic refractory breathlessness and guides interpretation of treatment effects.
Area of Science:
- Pulmonary Medicine
- Clinical Trials Methodology
Background:
- Defining clinically important differences in chronic refractory breathlessness is crucial for patient care and clinical trial design.
- Current understanding of meaningful change in breathlessness intensity is limited.
Purpose of the Study:
- To quantify the clinical relevance of breathlessness intensity changes using distribution and patient-reported outcomes.
- To establish a benchmark for minimal important difference in breathlessness scores.
Main Methods:
- Retrospective analysis of 213 datasets from four refractory breathlessness trials.
- Linear regression to correlate effect size with breathlessness score changes (0-100mm visual analogue scale).
- Analysis of pooled patient preference data from three randomized controlled trials.
Main Results:
- A strong correlation was found between breathlessness score change and study effect size (R² = 0.98).
- Estimated changes for small, moderate, and large effects were -5.5mm, -11.3mm, and -18.2mm, respectively.
- Patient preference data indicated a mean score change of -9mm.
Conclusions:
- A clinically important difference of 10mm in breathlessness is supported by this extensive dataset.
- Future clinical trials for refractory breathlessness should be powered to detect a 10mm difference.
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