Measurement methods of dyspnea in clinical trials of acute heart failure_Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Jingjing ^1,2 ,  LIU Yan ¹ , ZHANG Xiaoyu ² , CHEN Ying ^1,2 ,  SHANG Hongcai ¹

1. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, P.R.China;
2. Beijing University of Chinese Medicine, Beijing 100029, P.R.China;

Corresponding author：

LIU Yan, Email: liuyantcm@163.com; SHANG Hongcai, Email: shanghongcai@126.com

Keywords：

Acute heart failure; Dyspnea; Clinical trial; Measurement method

DOI：

10.7507/1672-2531.202004180

Video：

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Dyspnea is the most common symptom in patients with acute heart failure syndrome (AHFS), and relieving dyspnea is an important goal in clinical practice, clinical trials and new drug regulatory approval. However, in clinical and scientific research, there is still no consensus on how to evaluate dyspnea, and there is still a lack of unified measurement methods. This article introduces the pathophysiological mechanism of dyspnea in acute heart failure, the measuring time of dyspnea, the posture of patients during measurement, the measuring conditions, and the common measurement methods of dyspnea in clinical trials and their advantages and disadvantages, so as to provide references for the selection of measurement methods of dyspnea in clinical trials of acute heart failure.

Citation： ZHANG Jingjing, LIU Yan, ZHANG Xiaoyu, CHEN Ying, SHANG Hongcai. Measurement methods of dyspnea in clinical trials of acute heart failure. Chinese Journal of Evidence-Based Medicine, 2020, 20(11): 1334-1339. doi: 10.7507/1672-2531.202004180 Copy

1.	Filippatos G, Angermann CE, Cleland JGF, et al. Global differences in characteristics, precipitants, and initial management of patients presenting with acute heart failure. JAMA Cardiol, 2020, 5(4): 401-410.
2.	Zhang Y, Zhang J, Butler J, et al. Contemporary epidemiology, management, and outcomes of patients hospitalized for heart failure in china: results from the China Heart Failure (China-HF) Registry. J Card Fail, 2017, 23(12): 868-875.
3.	Sokolska JM, Sokolski M, Zymliński R, et al. Patterns of dyspnoea onset in patients with acute heart failure: clinical and prognostic implications. ESC Heart Fail, 2019, 6(1): 16-26.
4.	Teerlink JR. Dyspnea as an end point in clinical trials of therapies for acute decompensated heart failure. Am Heart J, 2003, 145(2 Suppl): S26-33.
5.	Gheorghiade M, Zannad F, Sopko G, et al. Acute heart failure syndromes: current state and framework for future research. Circulation, 2005, 112(25): 3958-3968.
6.	Parshall MB, Schwartzstein RM, Adams L, et al. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med, 2012, 185(4): 435-452.
7.	Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail, 2016, 18(8): 891-975.
8.	Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol, 2017, 70(6): 776-803.
9.	王华, 梁延春. 中国心力衰竭诊断和治疗指南2018. 中华心血管病杂志.
10.	王建枝, 钱睿哲. 病理生理学. 北京: 人民卫生出版社, 2018: 209-210.
11.	Mueller C, McDonald K, de Boer RA, et al. Heart Failure Association of the European Society of Cardiology practical guidance on the use of natriuretic peptide concentrations. Eur J Heart Fail, 2019, 21(6): 715-731.
12.	Pang PS, Collins SP, Sauser K, et al. Assessment of dyspnea early in acute heart failure: patient characteristics and response differences between likert and visual analog scales. Acad Emerg Med, 2014, 21(6): 659-666.
13.	Teerlink JR, Cotter G, Davison BA, et al. Serelaxin, recombinant human relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial. Lancet, 2013, 381(9860): 29-39.
14.	Metra M, Cleland JG, Weatherley BD, et al. Dyspnoea in patients with acute heart failure: an analysis of its clinical course, determinants, and relationship to 60-day outcomes in the PROTECT pilot study. Eur J Heart Fail, 2010, 12(5): 499-507.
15.	Metra M, O'Connor CM, Davison BA, et al. Early dyspnoea relief in acute heart failure: prevalence, association with mortality, and effect of rolofylline in the PROTECT Study. Eur Heart J, 2011, 32(12): 1519-1534.
16.	Mentz RJ, Hernandez AF, Stebbins A, et al. Predictors of early dyspnoea relief in acute heart failure and the association with 30-day outcomes: findings from ASCEND-HF. Eur J Heart Fail, 2013, 15(4): 456-464.
17.	Mebazaa A, Pang PS, Tavares M, et al. The impact of early standard therapy on dyspnoea in patients with acute heart failure: the URGENT-dyspnoea study. Eur Heart J, 2010, 31(7): 832-841.
18.	Pang PS, Konstam MA, Krasa HB, et al. Effects of tolvaptan on dyspnoea relief from the EVEREST trials. Eur Heart J, 2009, 30(18): 2233-2240.
19.	Pang PS, Cleland JG, Teerlink JR, et al. A proposal to standardize dyspnoea measurement in clinical trials of acute heart failure syndromes: the need for a uniform approach. Eur Heart J, 2008, 29(6): 816-824.
20.	Teerlink JR, McMurray JJ, Bourge RC, et al. Tezosentan in patients with acute heart failure: design of the Value of Endothelin Receptor Inhibition with Tezosentan in Acute heart failure Study (VERITAS). Am Heart J, 2005, 150(1): 46-53.
21.	Yeung AWK, Wong NSM. The historical roots of visual analog scale in psychology as revealed by reference publication year spectroscopy. Front Hum Neuro SCI, 2019, 13: 86.
22.	曹卉娟, 邢建民, 刘建平. 视觉模拟评分法在症状类结局评价测量中的应用. 中医杂志, 2009, 50(7): 600-602.
23.	杨丽虹, 刘少南, 吴大嵘, 等. 最小临床意义差值的概念及其估算方法. 中国循证医学杂志, 2020, 20(11): 1345-1352.
24.	Ander DS, Aisiku IP, Ratcliff JJ, et al. Measuring the dyspnea of decompensated heart failure with a visual analog scale: how much improvement is meaningful? Congest Heart Fail, 2004, 10(4): 188-191.
25.	Pang PS, Lane KA, Tavares M, et al. Is there a clinically meaningful difference in patient reported dyspnea in acute heart failure? An analysis from URGENT Dyspnea. Heart Lung, 2017, 46(4): 300-307.
26.	赵茜, 赵东方, 李冰洁, 等. 量表的选项顺序效应及其影响因素分析—以教育领域的李克特量表为例. 中国考试, 2020, (4): 22-27.
27.	Likert R. A technique for the measurement of attitudes. Arch Psychol, 1932, 22(140): 1-55.
28.	Likert R, Roslow S, Murphy G. A simple and reliable method of scoring the Thurston attitude scales. Person Psychol, 2006, 46(3): 689-690.
29.	West RL, Hernandez AF, O'Connor CM, et al. A review of dyspnea in acute heart failure syndromes. Am Heart J, 2010, 160(2): 209-214.

1. Filippatos G, Angermann CE, Cleland JGF, et al. Global differences in characteristics, precipitants, and initial management of patients presenting with acute heart failure. JAMA Cardiol, 2020, 5(4): 401-410.
2. Zhang Y, Zhang J, Butler J, et al. Contemporary epidemiology, management, and outcomes of patients hospitalized for heart failure in china: results from the China Heart Failure (China-HF) Registry. J Card Fail, 2017, 23(12): 868-875.
3. Sokolska JM, Sokolski M, Zymliński R, et al. Patterns of dyspnoea onset in patients with acute heart failure: clinical and prognostic implications. ESC Heart Fail, 2019, 6(1): 16-26.
4. Teerlink JR. Dyspnea as an end point in clinical trials of therapies for acute decompensated heart failure. Am Heart J, 2003, 145(2 Suppl): S26-33.
5. Gheorghiade M, Zannad F, Sopko G, et al. Acute heart failure syndromes: current state and framework for future research. Circulation, 2005, 112(25): 3958-3968.
6. Parshall MB, Schwartzstein RM, Adams L, et al. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med, 2012, 185(4): 435-452.
7. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail, 2016, 18(8): 891-975.
8. Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol, 2017, 70(6): 776-803.
9. 王华, 梁延春. 中国心力衰竭诊断和治疗指南2018. 中华心血管病杂志.
10. 王建枝, 钱睿哲. 病理生理学. 北京: 人民卫生出版社, 2018: 209-210.
11. Mueller C, McDonald K, de Boer RA, et al. Heart Failure Association of the European Society of Cardiology practical guidance on the use of natriuretic peptide concentrations. Eur J Heart Fail, 2019, 21(6): 715-731.
12. Pang PS, Collins SP, Sauser K, et al. Assessment of dyspnea early in acute heart failure: patient characteristics and response differences between likert and visual analog scales. Acad Emerg Med, 2014, 21(6): 659-666.
13. Teerlink JR, Cotter G, Davison BA, et al. Serelaxin, recombinant human relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial. Lancet, 2013, 381(9860): 29-39.
14. Metra M, Cleland JG, Weatherley BD, et al. Dyspnoea in patients with acute heart failure: an analysis of its clinical course, determinants, and relationship to 60-day outcomes in the PROTECT pilot study. Eur J Heart Fail, 2010, 12(5): 499-507.
15. Metra M, O'Connor CM, Davison BA, et al. Early dyspnoea relief in acute heart failure: prevalence, association with mortality, and effect of rolofylline in the PROTECT Study. Eur Heart J, 2011, 32(12): 1519-1534.
16. Mentz RJ, Hernandez AF, Stebbins A, et al. Predictors of early dyspnoea relief in acute heart failure and the association with 30-day outcomes: findings from ASCEND-HF. Eur J Heart Fail, 2013, 15(4): 456-464.
17. Mebazaa A, Pang PS, Tavares M, et al. The impact of early standard therapy on dyspnoea in patients with acute heart failure: the URGENT-dyspnoea study. Eur Heart J, 2010, 31(7): 832-841.
18. Pang PS, Konstam MA, Krasa HB, et al. Effects of tolvaptan on dyspnoea relief from the EVEREST trials. Eur Heart J, 2009, 30(18): 2233-2240.
19. Pang PS, Cleland JG, Teerlink JR, et al. A proposal to standardize dyspnoea measurement in clinical trials of acute heart failure syndromes: the need for a uniform approach. Eur Heart J, 2008, 29(6): 816-824.
20. Teerlink JR, McMurray JJ, Bourge RC, et al. Tezosentan in patients with acute heart failure: design of the Value of Endothelin Receptor Inhibition with Tezosentan in Acute heart failure Study (VERITAS). Am Heart J, 2005, 150(1): 46-53.
21. Yeung AWK, Wong NSM. The historical roots of visual analog scale in psychology as revealed by reference publication year spectroscopy. Front Hum Neuro SCI, 2019, 13: 86.
22. 曹卉娟, 邢建民, 刘建平. 视觉模拟评分法在症状类结局评价测量中的应用. 中医杂志, 2009, 50(7): 600-602.
23. 杨丽虹, 刘少南, 吴大嵘, 等. 最小临床意义差值的概念及其估算方法. 中国循证医学杂志, 2020, 20(11): 1345-1352.
24. Ander DS, Aisiku IP, Ratcliff JJ, et al. Measuring the dyspnea of decompensated heart failure with a visual analog scale: how much improvement is meaningful? Congest Heart Fail, 2004, 10(4): 188-191.
25. Pang PS, Lane KA, Tavares M, et al. Is there a clinically meaningful difference in patient reported dyspnea in acute heart failure? An analysis from URGENT Dyspnea. Heart Lung, 2017, 46(4): 300-307.
26. 赵茜, 赵东方, 李冰洁, 等. 量表的选项顺序效应及其影响因素分析—以教育领域的李克特量表为例. 中国考试, 2020, (4): 22-27.
27. Likert R. A technique for the measurement of attitudes. Arch Psychol, 1932, 22(140): 1-55.
28. Likert R, Roslow S, Murphy G. A simple and reliable method of scoring the Thurston attitude scales. Person Psychol, 2006, 46(3): 689-690.
29. West RL, Hernandez AF, O'Connor CM, et al. A review of dyspnea in acute heart failure syndromes. Am Heart J, 2010, 160(2): 209-214.

Chinese Journal of Evidence-Based Medicine

Measurement methods of dyspnea in clinical trials of acute heart failure

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