PMID- 32341113 OWN - NLM STAT- MEDLINE DCOM- 20210621 LR - 20210621 IS - 1399-3003 (Electronic) IS - 0903-1936 (Linking) VI - 56 IP - 2 DP - 2020 Aug TI - Minimal clinically important differences in average, best, worst and current intensity and unpleasantness of chronic breathlessness. LID - 1902202 [pii] LID - 10.1183/13993003.02202-2019 [doi] AB - 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 approximately 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. CI - Copyright (c)ERS 2020. FAU - Ekstrom, Magnus AU - Ekstrom M AD - Dept of Clinical Sciences, Division of Respiratory Medicine and Allergology, Lund University, Lund, Sweden pmekstrom@gmail.com. AD - IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, Australia. FAU - Johnson, Miriam J AU - Johnson MJ AD - Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, UK. FAU - Huang, Chao AU - Huang C AD - Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, UK. FAU - Currow, David C AU - Currow DC AD - IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, Australia. AD - Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, UK. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20200813 PL - England TA - Eur Respir J JT - The European respiratory journal JID - 8803460 RN - 76I7G6D29C (Morphine) SB - IM MH - Aged MH - *Dyspnea MH - Female MH - Humans MH - Male MH - *Minimal Clinically Important Difference MH - Morphine MH - Pain Measurement MH - Self Report COIS- Conflict of interest: M. Ekstrom has nothing to disclose. Conflict of interest: M.J. Johnson has nothing to disclose. Conflict of interest: C. Huang has nothing to disclose. Conflict of interest: D.C. Currow is an unpaid member of an advisory board for Helsinn Pharmaceuticals, is a consultant to Specialised Therapeutics and Mayne Pharma and received intellectual property payments from Mayne Pharma. EDAT- 2020/04/29 06:00 MHDA- 2021/06/22 06:00 CRDT- 2020/04/29 06:00 PHST- 2019/11/14 00:00 [received] PHST- 2020/04/14 00:00 [accepted] PHST- 2020/04/29 06:00 [pubmed] PHST- 2021/06/22 06:00 [medline] PHST- 2020/04/29 06:00 [entrez] AID - 13993003.02202-2019 [pii] AID - 10.1183/13993003.02202-2019 [doi] PST - epublish SO - Eur Respir J. 2020 Aug 13;56(2):1902202. doi: 10.1183/13993003.02202-2019. Print 2020 Aug.