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Clinically important differences in the intensity of chronic refractory breathlessness

Johnson, Miriam J.; Bland, J. Martin; Oxberry, Stephen G.; Abernethy, Amy P.; Currow, David C.

Authors

J. Martin Bland

Stephen G. Oxberry

Amy P. Abernethy

David C. Currow



Abstract

Context: Clinically important differences in chronic refractory breathlessness are ill defined but important in clinical practice and trial design. Objectives: To estimate the clinical relevance of differences in breathlessness intensity using distribution and patient anchor methods. Methods: This 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 (0-100 mm 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. Results: There 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 -18.2 mm. The participant preference change in score was -9 mm (95% CI, -15.8, -2.1) (P = 0.008). Conclusion: This larger dataset supports a clinically important difference of 10 mm. Studies should be powered to detect this difference.

Citation

Johnson, M. J., Bland, J. M., Oxberry, S. G., Abernethy, A. P., & Currow, D. C. (2013). Clinically important differences in the intensity of chronic refractory breathlessness. Journal of pain and symptom management, 46(6), 957-963. https://doi.org/10.1016/j.jpainsymman.2013.01.011

Journal Article Type Article
Acceptance Date Jan 28, 2013
Publication Date 2013-12
Deposit Date Jun 20, 2016
Publicly Available Date Jun 20, 2016
Journal Journal of pain and symptom management
Print ISSN 0885-3924
Electronic ISSN 1873-6513
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 46
Issue 6
Pages 957-963
DOI https://doi.org/10.1016/j.jpainsymman.2013.01.011
Keywords Minimal clinically important difference, Breathlessness, Dyspnea, Opioid
Public URL https://hull-repository.worktribe.com/output/439861
Publisher URL http://www.sciencedirect.com/science/article/pii/S0885392413001863
Additional Information This is the authors' accepted manuscript of an article published in Journal of pain and symptom management, 2013, v.46 issue 6.

Files

2016-06-17 Johnson fig 1 word.pdf (83 Kb)
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Publisher Licence URL
http://creativecommons.org/licenses/by-nc-nd/4.0/


2016-06-17 Johnson.pdf (240 Kb)
PDF

Publisher Licence URL
http://creativecommons.org/licenses/by-nc-nd/4.0/



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