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J Pain Symptom Manage · Dec 2013
Multicenter Study Comparative StudyClinically important differences in the intensity of chronic refractory breathlessness.
- Miriam J Johnson, J Martin Bland, Stephen G Oxberry, Amy P Abernethy, and David C Currow.
- Palliative Medicine, Hull York Medical School, University of Hull, Hull, United Kingdom. Electronic address: miriam.johnson@hyms.ac.uk.
- J Pain Symptom Manage. 2013 Dec 1; 46 (6): 957-63.
ContextClinically important differences in chronic refractory breathlessness are ill defined but important in clinical practice and trial design.ObjectivesTo estimate the clinical relevance of differences in breathlessness intensity using distribution and patient anchor methods.MethodsThis was a retrospective data analysis from 213 datasets from four clinical trials for refractory breathlessness. Linear regression was used to explore the relationship between study effect size and change in breathlessness score (0-100mm visual analogue scale) and to estimate the change in score equivalent to small, moderate, and large effect sizes. Pooled individual blinded patient preference data from three randomized controlled trials were analyzed. The difference between the mean change in Day 4 minus baseline scores between preferred and non-preferred arms was calculated.ResultsThere was a strong relationship between change in score and effect size (P = 0.001; R(2) = 0.98). Values for small, moderate, and large effects were -5.5, -11.3, and -18.2mm. The participant preference change in score was -9mm (95% CI, -15.8, -2.1) (P = 0.008).ConclusionThis larger dataset supports a clinically important difference of 10mm. Studies should be powered to detect this difference.Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.
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