Standardized Reporting Criteria for Studies Evaluating Suspected Acute Heart Failure Syndromes in the Emergency Department

Journal of the American College of Cardiology Vol. 60, No. 9, 2012© 2012 by the American College of Cardiology Foundation ISSN 0735-1097/$36.00

Heart Failure: Viewpoint

Standardized Reporting Criteria forStudies Evaluating Suspected Acute HeartFailure Syndromes in the Emergency Department

Standardized Reporting Criteria Working Group: Alan B. Storrow, MD, Co-Chair,*Christopher J. Lindsell, PHD, Co-Chair,† Sean P. Collins, MD, MSC,* Deborah B. Diercks, MD,‡Gerasimos S. Filippatos, MD,§ Brian C. Hiestand, MD, MPH,** Judd E. Hollander, MD,¶J. Douglas Kirk, MD,‡ Phillip D. Levy, MD, MPH,# Chadwick D. Miller, MD,**Allen J. Naftilan, MD,* Richard M. Nowak, MD,†† Peter S. Pang, MD,‡‡ W. Frank Peacock, MD,§§Mihai Gheorghiade, MD,‡‡ John G. F. Cleland, MD��

For the Multidisciplinary EMERG-HF: Mihai Gheorghiade, MD,‡‡ Sean Collins, MD, MSc,*Co-Chairs Members: William T. Abraham, MD,� Ezra A. Amsterdam, MD,‡ John G. F. Cleland, MD,‡Deborah B. Diercks, MD,‡ Stephanie Dunlap, DO,† Gerasimos S. Filippatos, MD,� Jalal Ghali, MD,**Robert Hobbs, MD,§§ Brian C. Hiestand, MD, MPH,** Judd E. Hollander, MD,¶ J. Douglas Kirk, MD,‡Dimitrios Kremastinos, MD,§ Phillip D. Levy, MD, MPH,# Christopher J. Lindsell, PHD,†Jim McCord, MD,†† Chadwick D. Miller, MD,** Allen J. Naftilan, MD,* Richard M. Nowak, MD,††Peter S. Pang, MD,‡‡ W. Frank Peacock, MD,§§ Alan B. Storrow, MD,* Vinay Thohan, MD**

Endorsed by the American Heart Association, Working Group on Acute Cardiac Care of the European Society ofCardiology, the Society of Academic Emergency Medicine, the American College of Emergency Physicians, andthe Society of Chest Pain Centers

Cincinnati and Columbus, Ohio; Sacramento, California; Athens, Greece; Philadelphia, Pennsylvania;Detroit, Michigan; Winston-Salem, North Carolina; Chicago, Illinois; Houston, Texas;and Kingston-upon Hull, United Kingdom

Heart failure requiring urgent therapy represents a burgeoning health care burden. Although acute heart failuresyndromes are commonly defined as a change in chronic heart failure signs and symptoms requiring urgenttherapy, the presentation, development, and response to treatment is highly dependent on individual patientcharacteristics. This heterogeneity has led to challenges in interpreting widely differing study methods, includingeligibility requirements and outcome measures. To improve interpretation of results and translate such informa-tion to better patient care, it is essential to present an accurate description of the patient population and studydesign. Based on existing recommendations and expert consensus, the authors present standardized reportingcriteria to improve interpretability of research in this challenging cohort. (J Am Coll Cardiol 2012;60:822–32)© 2012 by the American College of Cardiology Foundation

Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jacc.2012.03.072

Nowak has research support relationships with Brahms and Nanosphere. Over thepast 3 years, Dr. Miller was a speaker at a CME event supported by an educationalgrant from Sanofi Aventis; has had consulting relationships with The MedicinesCompany and Breathquant Medical LLC; and has cardiovascular research supportrelationships with Biosite Inc., Johnson & Johnson/Scios Inc., POL Biopharma,GlaxoSmithKline, Siemens, BreathQuant Medical LLC, Heartscape Technologies

From the *Vanderbilt University, Nashville, Tennessee; †University of Cincinnati,Cincinnati, Ohio; ‡University of California-Davis, Sacramento, California; §Evan-gelismos Hospital, Athens, Greece; �Ohio State University, Columbus, Ohio;¶University of Pennsylvania, Philadelphia, Pennsylvania; #Wayne State University,Detroit, Michigan; **Wake Forest University, Winston-Salem, North Carolina;††Henry Ford Hospital, Detroit, Michigan; ‡‡Northwestern University Feinberg
School of Medicine, Chicago, Illinois; §§Baylor College of Medicine, Houston,Texas; and the � �University of Hull, Kingston-upon-Hull, United Kingdom. Dr.
Inc., and Schering-Plough. Dr. Hiestand has received research funding fromMedtronic Inc., Biosite Inc., Inovise Medical Inc., Heartscape International, Nano-

r

823JACC Vol. 60, No. 9, 2012 Storrow et al.August 28, 2012:822–32 The AHFS Reporting Criteria

The emergent evaluation and management of patients withpossible acute heart failure syndromes (AHFS) remains asignificant challenge. Unlike major advances in the assess-ment and treatment of patients with acute coronary syn-dromes, the diagnostic tools and therapeutic options forpatients presenting with AHFS have changed little fordecades (1), and the complexity of AHFS has led to a practice ofisk aversion and extremely high hospitalization rates (2–5). These

difficulties, as well as the increasing prevalence of heart failure,have placed an enormous burden on health care resources world-wide (2).

The cohort of AHFS patients is diverse. Although theymight be commonly defined as patients with a gradual orrapid change in chronic heart failure signs and symptomsresulting in a need for urgent or unscheduled therapy(4,6,7), the development, presentation, and response totreatment is dependent on each individual’s pathophysiol-ogy and comorbidities. Researchers have studied a widerange of patient populations with different eligibility criteriaand medical histories and using divergent outcome mea-sures. To better interpret available research in the light ofthis study-related heterogeneity and to improve the level ofevidence supporting the acute evaluation and managementof the AHFS patient, it is critical to present a thorough

sphere Inc., Mitsubishi Chemical Medience, and The Medicines Company; and hasa medical writing consulting relationship with newMentor Inc. Dr. Collins hasprevious or current grant/research support relationships with Biosignetics, InoviseMedical Inc., Abbott Point-of-Care, NIH/NHLBI, Corthera, and Brahms; previousor current consulting relationships with Abbott Point-of-Care, POL BioPharma,Astellas, Otsuka Pharmaceuticals, and Bayer; and previous or current scientificadvisory board relationships with Astellas, The Medicines Company, and Corthera.Dr. Levy has consulting relationships with The Medicines Company (Data SafetyMonitoring Board), Corthera Inc., Bayer Schering Pharma AG, and EKR Thera-peutics; has or had grant/research support relationships with the Robert WoodJohnson Foundation Physician Faculty Scholars Program, the National Institutes ofHealth Loan Repayment Program, The Cleveland Clinic Foundation, Nile Thera-peutics, Astellas Pharma Inc., Corthera Inc., Solvay Pharmaceuticals Inc., BayerSchering Pharma AG, and Inovise Medical; and has a Speakers’ Bureau relationshipwith the Society of Chest Pain Centers. Dr. Peacock has ownership interest in VitalSensors; has research/grant relationships with Abbott, BAS, Biosite, Brahms,Inverness, Nanosphere, EKR, and The Medicines Company; has Scientific AdvisoryBoard relationships with Abbott, Beckman-Coulter, Biosite, Inverness, and TheMedicines Company; and has Speakers’ Bureau relationships with Abbott andBiosite. Within the past 5 years, Dr. Pang is or has been a consultant for Astellas,Bayer, EKR Therapeutics, Johnson & Johnson, The Medicines Company, Otsuka,Palatin Technologies, PDL BioPharma, Pericor Therapeutics, SigmaTau, and SolvayPharmaceuticals; has or had honoraria relationships with Biogenldec, Corthera,Ikaria, and Nile Therapeutics; and has or had research support relationships withAbbott, Merck, and PDL BioPharma. Dr. Cleland has investigator and advisorygroup relationships with Merck Sharpe and Dohme, Corthera/Novartis, and Actelionfor which he has received research funding support and personal payment. Dr.Gheorghiade has consulting relationships with Abbott Labs, Astellas, AstraZeneca,Bayer Schering Pharma AG, Corthera Inc., Cytokinetics Inc., DebioPharm S.A.,Errekappa Terapeutici, GlaxoSmithKline, Johnson & Johnson, Medtronic, Merck,Novartis Pharma AG, Otsuka Pharmaceuticals, Pericor Therapeutics, Protein DesignLaboratories, Sanofi Aventis, Sigma Tau, and Solvay Pharmaceuticals; and receivesfinancial support from Bayer Schering Pharma AG, DebioPharm S.A., Medtronic,Novartis Pharma AG, Otsuka Pharmaceuticals, Sigma Tau, Solvay Pharmaceuticals,DebioPharm S.A., and Pericor Therapeutics. All other authors have reported thatthey have no relationships relevant to the contents of this paper to disclose.

Manuscript received December 2, 2011; revised manuscript received February 8,2012, accepted March 7, 2012.

description of the patient popu-lation evaluated. Methods of pa-tient selection, demographicsand medical history of eligiblepatients, intervention or evalua-tion protocols, outcome mea-sures, and time intervals for mea-surements must be consistentlyreported. Based on existing rec-ommendations and expert con-sensus, these guidelines aim toprovide investigators a frame-work for reporting studies of pa-tients with possible AHFS. Byproviding these standardizedreporting criteria, we hope toimprove the interpretability ofresearch in this challenging pa-tient cohort and thus to im-prove patient care through bet-ter application of evidence-based medicine.

Development of Criteria

A working group of the Emergency Management andResearch Group in Acute Heart Failure met in May 2007 tobegin developing the reporting guidelines. Eight areas ofimportance were identified and assigned to working group mem-bers to develop initial recommendations based on existing guide-lines:

1. Screening and recruitment2. Demographics3. Previous cardiac diagnosis, risk factors, medical history4. Acute presentation (clinical characteristics)5. Test reporting and observation care6. Patient course including response to treatment7. Outcomes8. Follow-up periodThe initial recommendations were modified and circu-

lated to working group members before in-person meetingsin October 2007, May 2008, October 2008, and May 2009.At these meetings, each proposed reporting element wasdiscussed for incorporation as a core measure, supplementalmeasure, or dropped from further consideration.

The working draft was then distributed among thevarious stakeholders, including other members of Emer-gency Management and Research Group in Acute HeartFailure, for expansion and revision throughout 2010 andearly 2011. Representatives of the Society of AcademicEmergency Medicine, the American College of EmergencyPhysicians, the American Heart Association, the AmericanCollege of Cardiology, the Heart Failure Society of Amer-ica, the Society of Chest Pain Centers, and the WorkingGroup of Acute Cardiac Care of the European Society ofCardiology were given the opportunity to review and revise

Abbreviationsand Acronyms

AHFS � acute heart failuresyndrome

BNP � B-type natriureticpeptide

CAD � coronary arterydisease

ECG � electrocardiogram

ED � emergencydepartment

GFR � glomerular filtrationrate

ICD � implantablecardioverter-defibrillator

MI � myocardial infarction

NT-proBNP � N-terminalpro–BNP

the reporting guidelines. Once cons
ensus was achieved, the

824 Storrow et al. JACC Vol. 60, No. 9, 2012The AHFS Reporting Criteria August 28, 2012:822–32

Standardized Reporting Guidelines for Studies Evaluat-ing Suspected Acute Heart Failure Syndromes in theEmergency Department were finalized for publication.The guidelines have been endorsed by Society of Aca-demic Emergency Medicine, American College of Emer-gency Physicians, American Heart Association, Societyof Chest Pain Centers, and the Working Group on AcuteCardiac Care of the European Society of Cardiology.

Structure and Suggestions forUse of This Document

These guidelines emphasize the minimum information thatshould be reported and additional information that wouldbe of benefit to report when presenting studies of theevaluation and management of AHFS. The structure issimilar to recently introduced reporting guidelines for pos-sible acute coronary syndromes (8). Where available, wehave used the definition of data elements as provided by theAmerican College of Cardiology, American Heart Associ-ation, European Society of Cardiology, Heart Failure Soci-ety of America, Society of Chest Pain Centers, or WorldHeart Federation (9–18). Where definitions do not exist orare insufficient to clarify ambiguity in reporting, new defi-nitions have been provided.

Throughout the document, bolded items are identified ascore components (Table 1), and these should be reported inall studies of the evaluation and management of AHFS.Supplemental items are not bolded but should be reportedwhenever possible. Core components represent the minimalamount of information necessary to compare and contraststudies and can be used by investigators to guide datacollection and presentation of results. As well as facilitatingthe design of studies, peer reviewers evaluating manuscriptsfor publication may use these criteria to determine whethersufficient information is reported to allow readers to placethe study in appropriate context and compare results withthose of other publications. Clinicians may find it helpful touse the core criteria to determine whether reported popu-lations are similar to the patients they treat and thusfacilitate an evidence-based medicine approach to the acuteevaluation and management of AHFS. Reporting AHFSstudies in accordance with the guidelines will facilitatesystematic review and meta-analysis, maximizing the impactof research on clinical practice.

1. Screening and RecruitmentPatients with AHFS are a heterogeneous population.The performance of diagnostic and prognostic interven-tions is dependent on the severity, prevalence, andpathophysiology of the disease in the study population,as well as comorbid conditions or alternative diagnoses.The methods of screening and recruiting subjects andstudy inclusion and exclusion criteria are key factorsaffecting these parameters and thus should be reported.

1.1. Specific ages for inclusion and exclusion

1.2. Procedure for identifying population to bescreened

1.2.1. Signs, symptoms, or other criteria to promptscreening

1.2.2. Days and times of screening1.2.3. Location of screening

1.3. Method of screening1.3.1. By symptoms at presentation

1.3.1.1. The specific symptoms used for inclu-sion and exclusion

1.3.1.2. The time of onset and duration ofsymptoms used for inclusion andexclusion

1.3.2. By emergency department (ED) discharge/hospital admission diagnosis

1.3.3. By hospital discharge diagnosis1.3.4. By diagnostic testing

1.3.4.1. Use of diagnostic testing (e.g., orderingechocardiography)

1.3.4.2. Results of diagnostic testing (e.g., ele-vated B-type natriuretic peptide [BNP])

1.3.5. By administration of medications (e.g., nitro-glycerin, furosemide)

1.3.6. By pre-specified criteria (e.g., FraminghamCriteria)

1.4. Account for patients screened and included andexcluded from the study

1.4.1. Flow diagram to account for all patients1.4.2. Report total ED census for participating in-

stitution(s)1.4.3. Report ED volume of potential patients (e.g.,

total number of patients evaluated for AHFS)1.4.4. Report volume of potential patients screened

2. DemographicsA description of the patients studied is important tounderstand the relevance of the study to specific popu-lations to allow comparisons of different patient popula-tions and for risk adjustments.

2.1. Sex2.2. Age2.3. Race, including method of determination (19):

2.3.1. American Indian or Alaska Native2.3.2. Asian2.3.3. Black or African American2.3.4. African descendent2.3.5. Native Hawaiian or other Pacific Islander2.3.6. White2.3.7. Other2.3.8. Mixed race

2.4. Ethnicity2.4.1 Hispanic

2.4.2. Non-Hispanic2.5. Insurance status (refers to the primary payor)

2.5.1. Private refers to all private medical insurance.

3


2.5.2. Self-pay refers to no identifiable source ofpayment for medical bills.

2.5.3. Other refers to local, regional, or nationalgovernment insurance program, charity, taxlevy, or other source of payment

2.5.4. In the United States, differentiate Medicarefrom Medicaid

2.6. Mode of transport (means by which the patientarrived at the ED)

2.6.1. Self/family2.6.2. Ground ambulance (basic, intermediate, or

advanced)2.6.3. Air ambulance2.6.4. Other

2.7. Source of patients (place where patient resides attime of acute presentation)

2.7.1. Home2.7.2. Other hospital facility2.7.3. Extended care facility2.7.4. Jail or prison2.7.5. Other

. Previous cardiac diagnosis, risk factors, and medicalhistoryIn the acute care setting, physicians frequently do nothave access to detailed medical records and, therefore,must typically rely on patient self-report. In studies ofAHFS conducted in the acute care setting, it is accept-able to rely on patient self-report of cardiac risk factors.However, the investigators must report the method ofevaluation.

3.1. Hypertension3.2. Family history of early coronary artery disease

(CAD) (acute myocardial infarction [MI], angina,or sudden cardiac death in a first-degree relative,male younger than 55 years of age, female youngerthan 65 years of age)

3.3. Diabetes mellitus (regardless of duration of diseaseor use of specific medications)

3.3.1. Type of diabetes mellitus treatment (diet, oralagents, insulin alone, or insulin with oralagents)

3.3.2. Year of onset or first diagnosis3.4. Smoking

3.4.1. Current (within 1 month)3.4.2. Recent (stopped between 1 month and 1 year

before enrollment)3.4.3. Former (stopped �1 year before enrollment)3.4.4. Never smoker

3.5. Hypercholesterolemia or hyperlipidemia3.6. Drug and alcohol use

3.6.1. Amount and duration3.6.2. Results of toxicology testing3.6.3. Current (within 1 month)3.6.4. Recent (stopped between 1 month and 1 year

before enrollment)

3.6.5. Former (stopped �1 year before enrollment)3.7. Renal Insufficiency

3.7.1. Elevated creatinine3.7.2. Reduced creatinine clearance or glomerular

filtration rate (GFR); investigators must identifythe method used to calculate these variables

3.7.3. Albuminuria3.8. Presence of obesity

3.8.1. Body mass index3.9. AMI. If the previous AMI is confirmed through

medical record review and meets the EuropeanSociety of Cardiology/American College of Cardiology/American Heart Association/World Heart Federationcriteria (16), this should be noted. If the history ofAMI cannot be confirmed to meet these criteria, thenit should be recorded as “reported history of AMI.” Ifan alternative definition is used, this should be given.

3.10. Known cardiovascular disease3.10.1. Heart failure (any previous episodes). If the

presence of heart failure is documented in themedical record, this should be noted. Other-wise, it should be reported as “self-reportedhistory of heart failure.”

3.10.1.1. Etiology of heart failure (if known)3.10.1.2. Preserved or reduced systolic function

and definition used3.10.2. CAD. If the presence of CAD is docu-

mented in the medical record through ob-jective criteria such as cardiac catheteriza-tion with significant stenosis, demonstratedelectrocardiographic changes, perfusion de-fects, or wall motion abnormalities on exerciseor pharmacological imaging studies, this shouldbe noted (11). Otherwise, it should be recordedas “self-reported history of CAD.”

3.10.2.1. Revascularization (percutaneous coro-nary intervention, coronary artery by-pass graft)

3.10.2.1.1 Type, number of grafts orstented vessels, year

3.10.3. Ventricular arrhythmias3.10.3.1. Ventricular tachycardia resulting in

symptoms or acute intervention3.10.3.2. Ventricular fibrillation

3.10.4. Cardiac arrest3.10.5. Atrial arrhythmias

3.10.5.1. Atrial fibrillation or flutter (20)3.10.5.1.1. First detected3.10.5.1.2. Paroxsymal3.10.5.1.3. Persistent

3.10.6. Peripheral vascular disease3.10.6.1. Peripheral arterial disease3.10.6.2. Venous thromboembolic disease

3.10.7. Cerebrovascular events3.10.8. Automatic internal cardiac defibrillator (ICD)

3.10.8.1. ICD only

4


3.10.8.2. Cardiac resynchronization therapy defi-brillator (cardiac resynchronizationtherapy � ICD)

3.10.9. Pacemaker3.10.9.1. Single chamber, dual chamber3.10.9.2. Biventricular

3.10.10. Valvular disease3.10.10.1. Native valve3.10.10.2. Prosthetic valve

3.11. Previous objective assessments of cardiac function3.11.1. Previous ejection fraction

3.11.1.1. Time interval from testing to ED visit3.11.1.2. Method used to assess ejection frac-

tion (e.g., echocardiography, catheteriza-tion, nuclear study)

3.11.2. Most recent known ejection fraction3.11.3. Presence or absence of diastolic dysfunction,

ventricular hypertrophy, regional wall motionabnormalities, valvular disease

3.11.4. Baseline (well or dry weight) BNP orN-terminal pro–BNP (NT-proBNP) values

3.12. Pulmonary disease3.12.1. Asthma3.12.2. Chronic obstructive pulmonary disease3.12.3. Other

3.13. Home treatment3.13.1. Current medications and definition used for

current3.13.1.1. Diuretics3.13.1.2. Vasodilators (e.g., nitroglycerin,

hydralazine)3.13.1.3. Angiotensin-converting enzyme

inhibitors3.13.1.4. Angiotensin-receptor blockers3.13.1.5. Inotropes3.13.1.6. Aspirin3.13.1.7. Adenosine diphosphate receptor

inhibitors3.13.1.8. Beta-blockers3.13.1.9. Calcium channel blockers

3.13.1.9.1. Amlodipine3.13.1.9.2. Other calcium channel

blockers3.13.1.10. Oral anticoagulants

3.13.1.10.1. Coumadin3.13.1.10.2. Others

3.13.1.11 Aldosterone antagonists3.13.1.12. Digoxin3.13.1.13. Alpha antagonists

3.13.2 Contraindications to recommended treatments3.13.3. Other home treatments

. Acute presentationThe vast majority of patients with AHFS will havedyspnea as their chief symptom. A clear yet concise
description of the degree and magnitude of breathless-
ness is therefore requisite for any investigation of AHFS,particularly those that involve stratification by severity ofpresentation or cross-population comparison. Quantifi-cation of symptom severity using tools such as the NewYork Heart Association classification system or relativeLikert scales (21,22) is considered useful, but theirvalidity may be limited by the subjectivity inherent topatient self-assessment. The recently proposed axismodel should be taken into consideration, however itsutility remains to be determined (23).

4.1. Dyspnea4.1.1. Onset

4.1.1.1. Abrupt4.1.1.2. Gradual

4.1.2. Character4.1.2.1. Exertional only (mild)4.1.2.2. At rest (moderate)

4.1.2.2.1. Without orthopnea4.1.2.2.2. With orthopnea4.1.2.2.3. Paroxysmal nocturnal

4.1.2.3. Respiratory distress (severe)4.1.2.3.1. Needs immediate noninva-

sive ventilatory support4.1.2.4. Respiratory failure

4.1.2.4.1. Needs immediate intubation4.1.3. Comparison with baseline4.1.4. Respiratory rate4.1.5. Oxygen saturation

4.1.5.1. Indicate amount of supplemental ox-ygen currently administered

4.1.6. Signs of pulmonary congestion4.1.6.1. Rales

4.1.6.1.1. Basilar only4.1.6.1.2. Less than one-half lung field4.1.6.1.3. More than one-half lung field

4.1.6.2. Wheeze4.1.6.3. Accessory muscle use

4.2. Other signs and symptoms4.2.1. Murmur (location, timing, and intensity)4.2.2. Gallop (S3, S4)

4.2.2.1. Auscultation4.2.2.2. Phonocardiography

4.2.3. Elevated jugular venous pressure4.2.4. Peripheral edema4.2.5. Hepatic congestion4.2.6. Ascites4.2.7. Anasarca4.2.8. Weight at baseline4.2.9. Weight gain

4.2.10. Height (for determination of GFR)4.2.11. Fatigue4.2.12. Syncope4.2.13. Chest pain4.2.14. Palpitations

4.3. Hemodynamic status. Hemodynamic status on
presentation is a critical determinant of AHFS


management (24,25) and has significant implica-tions for clinical trial design. Uniform reporting ofrelevant parameters, therefore, is essential. Bloodpressure is a particularly important variable to in-clude and should be presented as needed to bestcharacterize patient cohorts (7,26).

4.3.1. Blood pressure4.3.1.1. Continuous integers

4.3.1.1.1. Systolic4.3.1.1.2. Diastolic

4.3.1.2. Categorical (report cutoffs used)4.3.1.2.1. Hypertensive4.3.1.2.2. Normotensive4.3.1.2.3. Hypotensive4.3.1.2.4. Cardiogenic shock (hypo-

tension with signs ofhypoperfusion)

4.3.2. Heart rate4.3.3. Other parameters (report if available along

with method [invasive or noninvasive] bywhich they were obtained)

4.3.3.1. Cardiac index/output4.3.3.2. Systemic vascular resistance4.3.3.3. Stroke volume4.3.3.4. Pulmonary capillary wedge pressure

4.4. Precipitating factors. These are the factors that areconsidered causative for the acute event rather thancontributory to the underlying etiology of heartfailure.

4.4.1. Uncontrolled hypertension4.4.2. Acute cardiac ischemia/infarct4.4.3. Arrhythmia4.4.4. Noncompliance (e.g., medication, diet)4.4.5. Toxicity (e.g., cocaine, amphetamines)4.4.6. Acute valve problems (e.g., acute mitral

regurgitation)4.4.7. Myocarditis4.4.8. High-output states (e.g., thiamine deficiency,

thyrotoxicosis, sepsis, Paget’s disease, severeanemia)

4.4.9. Systemic infections (e.g., pneumonia, urinarytract)

4.4.10. Pulmonary embolism4.4.11 Development of comorbid states (e.g., renal

failure, anemia, hypothyroidism)

5. Test ReportingThe tests used to evaluate patients with AHFS in theacute setting typically include the electrocardiogram(ECG), chest radiographs, and laboratory assays. Each ofthese should be reported with sufficient detail to enableaccurate interpretation of the results. The lab resultsection (5.3) is meant to be an overview for bothdiagnostic and therapeutic studies. More detailed recom-mendations about biomarker reporting are available else-
where (27–30).
5.1. ECG5.1.1. Person(s) interpreting the ECGs5.1.2. Timing of ECG relative to presentation

5.1.2.1. Presenting ECG5.1.2.2. Out-of-hospital ECG5.1.2.3. Serial in-hospital ECGs

5.1.3. Findings suggestive of acute coronary syndrome5.1.3.1. Rate5.1.3.2. Rhythm5.1.3.3. Overall categorization of the ECG (31)

5.1.3.3.1. Normal5.1.3.3.2. Nonspecific ST-T wave

changes5.1.3.3.3. Abnormal but not diagnos-

tic of ischemia5.1.3.3.4. Infarction or ischemia known

to be old5.1.3.3.5. Ischemia or infarction not

known to be old5.1.3.3.6. Consistent with AMI (ST-

segment elevation or newleft bundle branch block)

5.1.4. Dynamic ECG analysis5.1.5. Presence of left bundle branch block

5.2. Chest radiograph5.2.1. Procedure used for imaging

5.2.1.1. Anteroposterior (portable) technique5.2.1.2. Posteroanterior and lateral technique

5.2.2. Person(s) interpreting the chest radiograph5.2.3. Findings on the chest radiograph

5.2.3.1. Cardiomegaly5.2.3.2. Pulmonary vascular redistribution

5.2.3.2.1. Mild5.2.3.2.2. Moderate (e.g., Kerley B

lines, fluid in fissure)5.2.3.2.3. Severe (pulmonary edema)

5.2.3.3. Pleural effusion5.2.3.4. Other major abnormality (e.g., pneu-

monia, mass)5.3. Lab results

5.3.1. Timing of the lab specimen5.3.1.1. Relative to symptom onset5.3.1.2. Relative to clinical characteristics

5.3.2. Serum chemistry and blood analysis results,including the units of measurement

5.3.2.1. Blood urea nitrogen or urea5.3.2.2. Creatinine5.3.2.3. GFR5.3.2.4. Sodium5.3.2.5. Hemoglobin5.3.2.6. Natriuretic peptides

5.3.2.6.1. Manufacturer name5.3.2.6.2. BNP5.3.2.6.3. NT-proBNP

5.3.2.7. Cardiac biomarkers


5.3.2.7.1. Assay type (high sensitivity ornormal) and manufacturer

5.3.2.7.2. Established cutoffs for nor-mal values and method bywhich they were derived

5.3.2.8. Other AHFS biomarkers may beconsidered5.3.2.8.1. Midregional pro-atrial natri-

uretic peptide, adrenomedullin5.3.3. Specimen collection and handling procedures

5.3.3.1. Detailed methods of sample handlingand compliance with manufacturerrecommendations

5.3.3.2. Phlebotomy tubes used (reagent),centrifugation, etc.

5.3.3.3. Assay performed individually or batched,run at time of blood draw or delayed

5.3.3.4. Location (e.g., at bedside, ED statlaboratory, offsite research laboratory)

5.3.3.5. Storage (e.g., sample frozen withinhow many hours of draw, flash frozenon liquid nitrogen, freezing tempera-ture, length of time frozen)

5.3.4. Marker performance relative to defined out-comes. This is a core requirement if theprimary objective of the investigation isassessment of marker performance; other-wise, it is a supplemental criterion.

5.3.4.1. Sensitivity, specificity, positive predic-tive value, negative predictive value, andlikelihood ratios with 95% confidenceintervals

5.3.4.2. Receiver-operating characteristic curvedata5.3.4.2.1. Optimal operating point and

how defined5.3.4.2.2. Interval likelihood ratios

5.3.5. Relevant confounders for the assays beingused. This is a core requirement if theprimary objective of the investigation isassessment of marker performance; other-wise, it is a supplemental criterion.

5.3.5.1. Proportion of patients with renal in-sufficiency

5.3.5.2. Body mass index for natriuretic pep-tide testing

6. Patient CoursePatient course can be quite variable for patients present-ing with AHFS. Medications administered as well as thetiming of interventions may have a significant impact onpatient course and disposition. Medications and inter-ventions should be reported according to whether theywere given early in the patient course or as secondarytreatment after initial therapy had not produced an
adequate response. Further categorization is also needed
to delineate whether the medication was given as aprimary treatment or a secondary (preventive) measure.

6.1. ED and hospital course6.1.1. ED disposition

6.1.1.1. Discharge6.1.1.2. Observation unit admission6.1.1.3. Inpatient admission6.1.1.4. Left ED against medical advice6.1.1.5. Died in ED6.1.1.6. Transferred

6.1.2. Observation unit management6.1.2.1. System

6.1.2.1.1. Virtual unit or defined space6.1.2.1.2. Level of monitoring (i.e.,

telemetry)6.1.2.1.3. Number of beds6.1.2.1.4. Eligibility criteria for unit

admission6.1.2.1.5. Heart failure specific or

general6.1.2.2. Personnel

6.1.2.2.1. The training characteristicsof personnel primarily re-sponsible for the patient un-dergoing observation care

6.1.2.3. Treatment protocols6.1.2.3.1. Therapeutic protocols or al-

gorithms in use for patientsundergoing observation care

6.1.2.3.2. Rate of protocol compliance6.1.2.4. The length of time under observation

status6.1.2.5. Disposition

6.1.2.5.1. Home6.1.2.5.1.1. Discharge cri-

teria, includingany consultationrequirements

6.1.2.5.2. Inpatient admission6.1.2.5.3. Left observation unit against

medical advice6.1.2.5.4. Died in observation unit

6.1.3. Inpatient admission6.1.3.1. Intensive care unit/cardiac care unit6.1.3.2. Telemetry6.1.3.3. Unmonitored floor bed6.1.3.4. Transferred6.1.3.2. Inpatient disposition

6.1.3.2.1. Home6.1.3.2.2. Died in hospital6.1.3.2.3. Hospice6.1.3.2.4. Transferred to another hospital6.1.3.2.5. Extended care facility

6.2. Therapeutics and interventions6.2.1. Pharmacological therapeutics

6.2.1.1. Aspirin


6.2.1.2. Vasoactives6.2.1.2.1. Nitroglycerin and route (intra-

venous, topical, sublingual)6.2.1.2.2. Nitroprusside6.2.1.2.3. Nesiritide6.2.1.2.4. Phenylephrine6.2.1.2.5. Norepinephrine6.2.1.2.6. Epinephrine6.2.1.2.7. Dopamine

6.2.1.3. Inotropic agents6.2.1.3.1. Dobutamine6.2.1.3.2. Milrinone6.2.1.3.3. Levosimendan

6.2.1.4. Diuretics6.2.1.4.1. Name of diuretic6.2.1.4.2. Dose6.2.1.4.3. Mode of administration (oral,

intravenous bolus, or con-tinuous infusion)

6.2.1.5. Beta-blockers6.2.1.6. Angiotensin-converting enzyme

inhibitors6.2.1.7. Angiotensin receptor blockers6.2.1.8. Aldosterone antagonists6.2.1.9. Morphine

6.2.1.10. Atropine6.2.1.11. Antiarrhythmic (e.g., adenosine, ami-

odarone)6.2.1.12. Antithrombins (e.g., unfractionated

heparin, low molecular weight hepa-rin, direct thrombin inhibitors)

6.2.1.13. Others6.2.2. Nonpharmacological therapeutics6.2.3. Interventions

6.2.3.1. Primary6.2.3.2. Secondary/preventive6.2.3.3. Noninvasive ventilation (continuous

positive airway pressure/bilevel posi-tive airway pressure)

6.2.3.4. Intubation6.2.3.5. Electrical cardioversion6.2.3.6. Defibrillation6.2.3.7. Right heart catheter, both as a 1-time

procedure to obtain diagnostic dataand a pulmonary artery catheter tofollow response to therapy

6.2.3.8. Left heart catheterization6.2.3.9. Single-chamber pacemaker

6.2.3.10. Biventricular pacemaker6.2.3.11. Implantable cardioverter-defibrillator6.2.3.12. Percutaneous coronary intervention6.2.3.13. Balloon pump6.2.3.14. Ultrafiltration6.2.3.15. Percutaneous cardiopulmonary support6.2.3.16. Ventricular assist device
6.2.3.17. Transplantation
6.2.3.18. Others6.2.4. Timing of therapy or intervention relative to

presentation6.2.4.1. Pre-hospital6.2.4.2. Early (within first 12 to 24 h)6.2.4.3. Late (after first 24 h)

6.2.5. Route of administration of therapy6.2.5.1. Oral6.2.5.2. Sublingual6.2.5.3. Intravenous6.2.5.4. Intramuscular/subcutaneous

6.2.6. Endotracheal tube6.2.7. Dose of therapy

6.3. Response to treatment6.3.1. Total urinary output6.3.2. Weight change during hospitalization6.3.3. Total input/output during hospitalization6.3.4. Laboratory values before discharge

6.3.4.1. Blood urea nitrogen6.3.4.2. Creatinine6.3.4.3. GFR6.3.4.4. Sodium6.3.4.5. Potassium6.3.4.6. BNP/NT-proBNP6.3.4.7. Hemoglobin

6.3.5. Hemodynamic values before discharge6.3.5.1. Blood pressure (systolic and diastolic)6.3.5.2. Heart rate

6.3.6. Respiratory status before discharge6.3.6.1. Respiratory rate6.3.6.2. Oxygen saturation including amount

of supplemental oxygen6.3.7. Jugular venous pressure before discharge

7. OutcomesHospitalization for AHFS is a significant marker forpost-discharge events (i.e., rehospitalization or mortal-ity). However, very few studies have been conducted thatlooked at short-term outcomes based on acute manage-ment. Development and establishment of short-termoutcome goals or targets is a current area of investiga-tional research, balancing the needs of clinicians, inves-tigators, and regulatory agencies. For studies of themanagement and evaluation of AHFS, therefore, thedefinition of outcomes appropriate to the study’s purposeshould be reported.

7.1. Safety and efficacy endpoints7.1.1. Mortality

7.1.1.1. Days from presentation (e.g., 5 days,7 days, 30 days, 180 days)

7.1.2. Morbidity7.1.2.1. Worsening heart failure (as defined

for the study)7.1.2.2. Days alive and out of hospital

7.1.3. Resource utilization
7.1.3.1. Lengths of stay

Continued in next column


7.1.3.2. Costs7.1.3.3. Recidivism

7.2. Organ protection/preservation/improvement7.2.1. Cardiac

7.2.1.1. Biomarkers7.2.1.2. ECG7.2.1.3. Echocardiographic indices7.2.1.4. Hemodynamic (specify invasive or

noninvasive)7.2.1.5. Serious arrhythmia (atrial fibrillation/

flutter, ventricular tachycardia, ven-tricular fibrillation)

7.2.2. Renal7.2.2.1. Blood urea nitrogen7.2.2.2. Creatinine7.2.2.3. Creatinine clearance or GFR (specify

method of calculation if estimated)7.2.2.4. Novel biomarkers7.2.2.5. Other

7.2.3. Stroke7.2.3.1. Hemorrhagic7.2.3.2. Nonhemorrhagic

7.3. Interventions7.3.1. Pharmacological

7.3.1.1. Need for rescue therapy (define)7.3.2. Surgical

ContinuedTable 1 Continued

6. Patient course

6.1. ED and hospital course

6.1.1. ED disposition

6.1.2. Observation unit management

6.1.2.5. Disposition

6.1.3. Inpatient admission

6.1.3.2. Inpatient disposition

6.2. Therapeutics and interventions

6.2.1. Pharmacological therapeutics

6.2.2. Nonpharmacological therapeutics

6.2.3. Interventions

6.2.3.1. Primary

6.2.3.2. Secondary/preventive

6.3. Response to treatment

6.3.8. Therapeutics given

6.3.9. Interventions

6.3.9.1. Primary

6.3.9.2. Secondary/preventive

6.4. Response to treatment

7. Outcomes

7.1. Safety and efficacy endpoints

7.1.1. Mortality

7.1.2. Morbidity

8. Follow-up

8.1. Duration of follow-up

8.2. Clinical follow-up and timing

8.3. Research follow-up

ECG � electrocardiogram; ED � emergency department.

Core ComponentsTable 1 Core Components

1. Screening and recruitment

1.1. Specific ages for inclusion and exclusion

1.2. Procedure for identifying population to be screened

1.3. Method of screening

1.4. Account for patients screened and included in and excludedfrom the study

2. Demographics

2.1. Sex

2.2. Age

2.3. Race

3. Previous cardiac diagnosis, risk factors, and medical history

3.1. Hypertension

3.3. Diabetes mellitus

3.4. Smoking

3.5. Hypercholesterolemia or hyperlipidemia

3.9. Acute myocardial infarction

3.10. Known cardiovascular disease

3.10.1. Heart failure

3.10.1.1. Etiology of heart failure (if known)

3.10.1.2. Preserved or reduced systolic function and definition used

3.10.2. Coronary artery disease.

3.11. Previous objective evaluations for heart failure

3.11.1. Previous ejection fraction or current ejection fraction

3.11.1.2. Method used to assess ejection fraction (e.g., echocardiography,catheterization, nuclear study)

3.13. Home treatment

4. Acute presentation

4.1. Dyspnea

4.1.4. Respiratory rate

4.1.5. Oxygen saturation

4.3. Hemodynamic status

4.3.1. Blood pressure

4.3.2. Heart rate

4.4. Precipitating factors

5. Test reporting

5.1. ECG

5.1.1. Person(s) interpreting the ECGs

5.1.2. Timing of the ECG relative to presentation

5.1.3. Findings suggestive of acute coronary syndrome

5.2. Chest radiograph

5.2.1. Procedure used for imaging

5.2.2. Person(s) interpreting the chest radiograph

5.2.3. Findings on the chest radiograph

5.3. Lab results

5.3.1. Timing of the lab specimen

5.3.2. Serum chemistry and blood analysis results, including the units ofmeasurement

5.3.3. Specimen collection and handling procedures

5.3.4. Marker performance relative to defined outcomes. This is a corerequirement if the primary objective of the investigation isassessment of marker performance; otherwise, it is a supplementalcriterion.

5.3.5. Relevant confounders for the assays being used. This is a corerequirement if the primary objective of the investigation isassessment of marker performance; otherwise, it is a supplementalcriterion.

7.3.3. Procedural

8


7.3.4. Airway management (endotracheal tube, non-invasive ventilation)

7.4. Symptoms and signs (distinguish between physicianassessed and patient assessed)

7.4.1. Dyspnea7.4.2. Jugular venous pressure7.4.3. Rales7.4.4. Edema7.4.5. Other

7.5. Quality of life7.5.1. Quality of life questionnaires (e.g., Kansas

City Cardiomyopathy Questionnaire)7.6. Response to therapy

7.6.1. Body weight7.6.2. Urine output7.6.3. Functional capacity (e.g., 6-min walk test)7.6.4. Other

7.7. Composite endpoints: each component needs to bespecifically defined

7.7.1. Global rank: events prioritized by importance(e.g., death � rehospitalization � biomarkerelevation); this method provides an opportu-nity for more subjects to experience an “endpoint”

7.7.2. Breakdown of individual endpoints of com-posite measure

. Follow-upThere are limited data available regarding a recom-mended time to follow-up after an ED visit or hospitalizationfor AHFS (13,32–34). Access to follow-up care may varydepending on several factors including availability of heartfailure specialty or primary care clinics and the patient’sinsurance status. Poor outpatient follow-up may exert consid-erable confounding on research outcomes. Patients with aninability to obtain appropriate medications or clinical follow-upmay experience adverse events independent of the researchintervention being applied. Both clinical and researchfollow-up should therefore be reported.

8.1. Duration of follow-up8.1.1. Start point of follow-up period

8.1.1.1. Presentation8.1.1.2. In-hospital/treatment events8.1.1.3. Discharge

8.2. Clinical follow-up and timing8.2.1. Access to and attendance at care providers

during the follow-up period8.2.1.1. Primary care8.2.1.2. Cardiologist8.2.1.3. Heart failure specialty clinic

8.3. Research follow-up8.3.1. Methodology

8.3.1.1. Telephone or in person8.3.1.2. Patient or proxy8.3.1.3. Use of medical record review

8.3.1.3.1. Primary follow-up method
8.3.1.3.2. Supplementary to contact
8.3.1.3.3. Confirmatory of reportedevents

8.3.1.4. Insurance/claims data8.3.1.5. National registry/Social Security Death

Index8.3.2. Proportion lost to follow-up

Reprint requests and correspondence: Dr. Alan Storrow, De-partment of Emergency Medicine, Vanderbilt University MedicalCenter, 703 Oxford House, Nashville, Tennessee 37232. E-mail:[email protected].

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Key Words: acute heart failure y emergency department y reportingcriteria y study design.

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Documents

Standardized Reporting Criteria for Studies Evaluating Suspected Acute Heart Failure Syndromes in the Emergency Department