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

<p>Abstract</p> <p>Background</p> <p>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 appropri...

Full description

Bibliographic Details
Main Authors: Tait Lynda, Roalfe Andrea K, Mant Jonathan, Cowie Martin R, Deeks Jonathan J, Iles Rachel, Barton Pelham M, Taylor Clare J, Derit Marites, Hobbs FD
Format: Article
Language:English
Published: BMC 2012-10-01
Series:BMC Cardiovascular Disorders
Subjects:
Online Access:http://www.biomedcentral.com/1471-2261/12/97
_version_ 1818498186569842688
author Tait Lynda
Roalfe Andrea K
Mant Jonathan
Cowie Martin R
Deeks Jonathan J
Iles Rachel
Barton Pelham M
Taylor Clare J
Derit Marites
Hobbs FD
author_facet Tait Lynda
Roalfe Andrea K
Mant Jonathan
Cowie Martin R
Deeks Jonathan J
Iles Rachel
Barton Pelham M
Taylor Clare J
Derit Marites
Hobbs FD
author_sort Tait Lynda
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p>ISRCTN17635379</p>
first_indexed 2024-12-10T18:54:55Z
format Article
id doaj.art-170c807ca8c24410915da9940e2cad19
institution Directory Open Access Journal
issn 1471-2261
language English
last_indexed 2024-12-10T18:54:55Z
publishDate 2012-10-01
publisher BMC
record_format Article
series BMC Cardiovascular Disorders
spelling doaj.art-170c807ca8c24410915da9940e2cad192022-12-22T01:37:12ZengBMCBMC Cardiovascular Disorders1471-22612012-10-011219710.1186/1471-2261-12-97The 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 designTait LyndaRoalfe Andrea KMant JonathanCowie Martin RDeeks Jonathan JIles RachelBarton Pelham MTaylor Clare JDerit MaritesHobbs FD<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p>ISRCTN17635379</p>http://www.biomedcentral.com/1471-2261/12/97Heart failureClinical decision ruleDiagnosisEchocardiogramNT-proBNP
spellingShingle Tait Lynda
Roalfe Andrea K
Mant Jonathan
Cowie Martin R
Deeks Jonathan J
Iles Rachel
Barton Pelham M
Taylor Clare J
Derit Marites
Hobbs FD
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
BMC Cardiovascular Disorders
Heart failure
Clinical decision rule
Diagnosis
Echocardiogram
NT-proBNP
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Heart failure
Clinical decision rule
Diagnosis
Echocardiogram
NT-proBNP
url http://www.biomedcentral.com/1471-2261/12/97
work_keys_str_mv AT taitlynda thereferreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT roalfeandreak thereferreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT mantjonathan thereferreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT cowiemartinr thereferreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT deeksjonathanj thereferreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT ilesrachel thereferreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT bartonpelhamm thereferreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT taylorclarej thereferreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT deritmarites thereferreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT hobbsfd thereferreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT taitlynda referreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT roalfeandreak referreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT mantjonathan referreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT cowiemartinr referreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT deeksjonathanj referreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT ilesrachel referreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT bartonpelhamm referreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT taylorclarej referreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT deritmarites referreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign
AT hobbsfd referreferforechocardiogramprotocolaprospectivevalidationofaclinicaldecisionrulentprobnportheircombinationinthediagnosisofheartfailureinprimarycarerationaleanddesign