European Heart Journal Advance Access originally published online on March 1, 2008
European Heart Journal 2008 29(6):816-824; doi:10.1093/eurheartj/ehn048
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A proposal to standardize dyspnoea measurement in clinical trials of acute heart failure syndromes: the need for a uniform approach
1 Department of Emergency Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
2 Department of Cardiology, Castle Hill Hospital, University of Hull, Kingston-upon-Hull, UK
3 Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco, San Francisco, CA, USA
4 Department of Emergency Medicine, University of Cincinnati, Cincinnati, OH, USA
5 National Institutes of Health, Bethesda, MD, USA
6 Department of Emergency Medicine, The Cleveland Clinic, Cleveland, OH, USA
7 Division of Cardiology, Department of Medicine, David Geffen School of Medicine at UCLA, University of California Los Angeles, CA, USA
8 Department of Emergency Medicine, University of California, Davis, Medical Center, Sacramento, CA, USA
9 Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, USA
10 Department of Anesthesiology and Critical Care, Hospital Geral de Santo António, Porto, Portugal
11 Department of Anesthesiology and Critical Care Medicine, Hopital Lariboisiere, Paris, France
12 Agence Francaise de Securite Sanitaire des Produits de Sante, Paris, France
13 Division of Cardiology, Department of Medicine, Veterans Affairs San Diego Health Care System, University of California San Diego, San Diego, CA, USA
14 Department of Cardiology, University Pierre Marie Curie, Paris, France
15 Pitie Salpetriere Hospital, Paris, France
16 Department of Cardiology, Heart Failure Unit, Athens University Hospital, Attikon, Greece
17 Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
Received 26 July 2007; revised 13 January 2008; accepted 17 January 2008; online publish-ahead-of-print 1 March 2008.
* Corresponding author. Tel: +44 1482 624 084, Fax: +44 1482 624 085, Email address: j.g.cleland{at}hull.ac.uk
Dyspnoea is the most common presenting symptom amongst patients with acute heart failure syndromes (AHFS). It is distressing to patients and therefore an important target for treatment in clinical practice, clinical trials, and for regulatory approval of novel agents. Despite its importance as a treatment target, no consensus exists on how to assess dyspnoea in this setting. There is a considerable uncertainty about the reproducibility of the various instruments used to measure dyspnoea, their ability to reflect changes in symptoms and whether they accurately reflect the patient’s experience. Little attempt has been made to ensure consistent implementation with respect to patients’ posture during assessment or timing in relationship to therapy. There is also limited understanding of how rapidly and completely dyspnoea responds to standard therapy. A standardized method with which to assess dyspnoea is required for clinical trials of AHFS in order to ensure uniform collection of data on a key endpoint. We propose the Provocative Dyspnoea Assessment, a method of measurement that combines sequential dyspnoea provocation by positioning and walking with a dyspnoea self assessment using a five-point Likert scale, to yield a final Dyspnoea Severity Score. This proposed tool requires detailed validation but has face validity for the uniform assessment of dyspnoea.
Key Words: Heart failure • Clinical trials • Dyspnoea