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Minimal clinically important differences in average, best, worst and current intensity and unpleasantness of chronic breathlessness

Ekström, Magnus LU orcid ; Johnson, Miriam J. ; Huang, Chao and Currow, David C. (2020) In European Respiratory Journal 56(2).
Abstract

Background: Chronic breathlessness has devastating consequences. The minimal clinically important difference (MCID) for current intensity has been estimated as 9 mm on a 100-mm visual analogue scale (VAS). We aimed to determine MCIDs for commonly used dimensions and recall periods: the current unpleasantness and current, average, best and worst intensity of the past 24 h for chronic breathlessness. Methods: This was a secondary analysis of a randomised controlled trial of morphine versus placebo over 7 days in people with chronic breathlessness from severe disease. The breathlessness scores were self-reported using a diary each evening on 100-mm VAS. The MCID for improvement in each score was estimated using anchor-based and... (More)

Background: Chronic breathlessness has devastating consequences. The minimal clinically important difference (MCID) for current intensity has been estimated as 9 mm on a 100-mm visual analogue scale (VAS). We aimed to determine MCIDs for commonly used dimensions and recall periods: the current unpleasantness and current, average, best and worst intensity of the past 24 h for chronic breathlessness. Methods: This was a secondary analysis of a randomised controlled trial of morphine versus placebo over 7 days in people with chronic breathlessness from severe disease. The breathlessness scores were self-reported using a diary each evening on 100-mm VAS. The MCID for improvement in each score was estimated using anchor-based and distribution-based methods. Results: 283 participants (mean age 74.2 years; 63% male; 58% COPD; 87.0% modified Medical Research Council (mMRC) score 3-4) were included. Anchor-based MCIDs for breathlessness scores ranged from −13.9 mm to −9.5 mm. The MCIDs were similar when using different anchors and across all participants, and participants with more severe breathlessness (mMRC 3-4). Distribution-based effect sizes were classed as small (−4.7−6.3 mm), moderate (−9.4−12.5 mm) and large (−15.0−20.0 mm) effect. Sample sizes for trials using the different scores were proposed. MCIDs of absolute change were more stable than using relative change from baseline. Conclusion: An improvement of ∼10 mm on a 100-mm VAS is likely to be clinically meaningful across commonly used measures of chronic breathlessness (current intensity, unpleasantness, and average, best and worst intensity over the past 24 h) to evaluate clinical benefit and effects in therapeutic trials.

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author
; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
European Respiratory Journal
volume
56
issue
2
article number
02202
publisher
European Respiratory Society
external identifiers
  • pmid:32341113
  • scopus:85087750330
ISSN
0903-1936
DOI
10.1183/13993003.02202-2019
language
English
LU publication?
yes
id
c7364489-14ed-4be6-bb05-f0f44eeb19f0
date added to LUP
2021-01-08 13:56:48
date last changed
2025-05-31 23:36:43
@article{c7364489-14ed-4be6-bb05-f0f44eeb19f0,
  abstract     = {{<p>Background: Chronic breathlessness has devastating consequences. The minimal clinically important difference (MCID) for current intensity has been estimated as 9 mm on a 100-mm visual analogue scale (VAS). We aimed to determine MCIDs for commonly used dimensions and recall periods: the current unpleasantness and current, average, best and worst intensity of the past 24 h for chronic breathlessness. Methods: This was a secondary analysis of a randomised controlled trial of morphine versus placebo over 7 days in people with chronic breathlessness from severe disease. The breathlessness scores were self-reported using a diary each evening on 100-mm VAS. The MCID for improvement in each score was estimated using anchor-based and distribution-based methods. Results: 283 participants (mean age 74.2 years; 63% male; 58% COPD; 87.0% modified Medical Research Council (mMRC) score 3-4) were included. Anchor-based MCIDs for breathlessness scores ranged from −13.9 mm to −9.5 mm. The MCIDs were similar when using different anchors and across all participants, and participants with more severe breathlessness (mMRC 3-4). Distribution-based effect sizes were classed as small (−4.7−6.3 mm), moderate (−9.4−12.5 mm) and large (−15.0−20.0 mm) effect. Sample sizes for trials using the different scores were proposed. MCIDs of absolute change were more stable than using relative change from baseline. Conclusion: An improvement of ∼10 mm on a 100-mm VAS is likely to be clinically meaningful across commonly used measures of chronic breathlessness (current intensity, unpleasantness, and average, best and worst intensity over the past 24 h) to evaluate clinical benefit and effects in therapeutic trials.</p>}},
  author       = {{Ekström, Magnus and Johnson, Miriam J. and Huang, Chao and Currow, David C.}},
  issn         = {{0903-1936}},
  language     = {{eng}},
  number       = {{2}},
  publisher    = {{European Respiratory Society}},
  series       = {{European Respiratory Journal}},
  title        = {{Minimal clinically important differences in average, best, worst and current intensity and unpleasantness of chronic breathlessness}},
  url          = {{http://dx.doi.org/10.1183/13993003.02202-2019}},
  doi          = {{10.1183/13993003.02202-2019}},
  volume       = {{56}},
  year         = {{2020}},
}