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Open Access Study protocol

The REFER (REFer for EchocaRdiogram) protocol: a prospective validation of a clinical decision rule, NT-proBNP, or their combination, in the diagnosis of heart failure in primary care. Rationale and design

Lynda Tait1, Andrea K Roalfe1, Jonathan Mant2, Martin R Cowie4, Jonathan J Deeks3, Rachel Iles1, Pelham M Barton5, Clare J Taylor1, Marites Derit1 and FD Richard Hobbs6*

Author Affiliations

1 Primary Care Clinical Sciences, Primary Care Clinical Sciences Building, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK

2 General Practice & Primary Care Research Unit, University of Cambridge, Forvie Site, Robinson Way, Cambridge, CB2 OSR, UK

3 Public Health, Epidemiology and Biostatistics, Public Health Building, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK

4 Imperial College London (Royal Brompton Hospital), London, SW3 6LY, UK

5 Health Economics Unit, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK

6 Department of General Practice, University of Oxford, 23-38 Hythe Bridge Street, Oxford, OX1 2ET, UK

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BMC Cardiovascular Disorders 2012, 12:97  doi:10.1186/1471-2261-12-97

Published: 30 October 2012

Abstract

Background

Heart failure is a major cause of mortality and morbidity. As mortality rates are high, it is important that patients seen by general practitioners with symptoms suggestive of heart failure are identified quickly and treated appropriately. Identifying patients with heart failure or deciding which patients need further tests is a challenge. All patients with suspected heart failure should be diagnosed using objective tests such as echocardiography, but it is expensive, often delayed, and limited by the significant skill shortage of trained echocardiographers. Alternative approaches for diagnosing heart failure are currently limited. Clinical decision tools that combine clinical signs, symptoms or patient characteristics are designed to be used to support clinical decision-making and validated according to strict methodological procedures. The REFER Study aims to determine the accuracy and cost-effectiveness of our previously derived novel, simple clinical decision rule, a natriuretic peptide assay, or their combination, in the triage for referral for echocardiography of symptomatic adult patients who present in general practice with symptoms suggestive of heart failure.

Methods/design

This is a prospective, Phase II observational, diagnostic validation study of a clinical decision rule, natriuretic peptides or their combination, for diagnosing heart failure in primary care. Consecutive adult primary care patients 55 years of age or over presenting to their general practitioner with a chief complaint of recent new onset shortness of breath, lethargy or peripheral ankle oedema of over 48 hours duration, with no obvious recurrent, acute or self-limiting cause will be enrolled. Our reference standard is based upon a three step expert specialist consensus using echocardiography and clinical variables and tests.

Discussion

Our clinical decision rule offers a potential solution to the diagnostic challenge of providing a timely and accurate diagnosis of heart failure in primary care. Study results will provide an evidence-base from which to develop heart failure care pathway recommendations and may be useful in standardising care. If demonstrated to be effective, the clinical decision rule will be of interest to researchers, policy makers and general practitioners worldwide.

Trial registration

ISRCTN17635379

Keywords:
Heart failure; Clinical decision rule; Diagnosis; Echocardiogram; NT-proBNP