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

Ekström, M; Johnson, MJ; Huang, C; Currow, DC

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

Ekström, M Johnson, MJ Huang, C Currow, DC

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Publisher:: EUROPEAN RESPIRATORY SOC JOURNALS LTD
Publication Type:: Journal Article
Citation:: The European respiratory journal, 2020, 56, (2)
Issue Date:: 2020-08-13

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Field	Value	Language
dc.contributor.author	Ekström, M
dc.contributor.author	Johnson, MJ
dc.contributor.author	Huang, C
dc.contributor.author	Currow, DC
dc.date.accessioned	2021-06-01T19:42:04Z
dc.date.available	2020-04-14
dc.date.available	2021-06-01T19:42:04Z
dc.date.issued	2020-08-13
dc.identifier.citation	The European respiratory journal, 2020, 56, (2)
dc.identifier.issn	0903-1936
dc.identifier.issn	1399-3003
dc.identifier.uri	http://hdl.handle.net/10453/149324
dc.description.abstract	<h4>Background</h4>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.<h4>Methods</h4>This was a secondary analysis of a randomised controlled trial of morphine <i>versus</i> 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.<h4>Results</h4>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.<h4>Conclusion</h4>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.
dc.format	Electronic-Print
dc.language	eng
dc.publisher	EUROPEAN RESPIRATORY SOC JOURNALS LTD
dc.relation.ispartof	The European respiratory journal
dc.relation.isbasedon	10.1183/13993003.02202-2019
dc.rights	info:eu-repo/semantics/closedAccess
dc.subject	1116 Medical Physiology, 11 Medical and Health Sciences
dc.subject.classification	Respiratory System
dc.title	Minimal clinically important differences in average, best, worst and current intensity and unpleasantness of chronic breathlessness.
dc.type	Journal Article
utslib.citation.volume	56
utslib.location.activity	England
utslib.for	1116 Medical Physiology
utslib.for	11 Medical and Health Sciences
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/IMPACCT
utslib.copyright.status	closed_access	*
dc.date.updated	2021-06-01T19:42:02Z
pubs.issue	2
pubs.publication-status	Published
pubs.volume	56
utslib.citation.issue	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 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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http://hdl.handle.net/10453/149324