For the Multidisciplinary EMERG-HF: Mihai Gheorghiade, MD,‡‡ Sean Collins, MD, MSc,*

Co-Chairs Members: William T. Abraham, MD,(5) 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**

The emergent evaluation and management of patients with possible acute heart failure syndromes (AHFS) remains a significant challenge. Unlike major advances in the assessment and treatment of patients with acute coronary syndromes, the diagnostic tools and therapeutic options for patients presenting with AHFS have changed little for decades (1), and the complexity of AHFS has led to a practice of risk aversion and extremely high hospitalization rates (2). These difficulties, as well as the increasing prevalence of heart failure, have placed an enormous burden on health care resources worldwide (2).

The cohort of AHFS patients is diverse. Although they might be commonly defined as patients with a gradual or rapid change in chronic heart failure signs and symptoms resulting in a need for urgent or unscheduled therapy (4), the development, presentation, and response to treatment is dependent on each individual's pathophysiology and comorbidities. Researchers have studied a wide range of patient populations with different eligibility criteria and medical histories and using divergent outcome measures. To better interpret available research in the light of this study-related heterogeneity and to improve the level of evidence supporting the acute evaluation and management of the AHFS patient, it is critical to present a thorough description of the patient population evaluated. Methods of patient selection, demographics and medical history of eligible patients, intervention or evaluation protocols, outcome measures, and time intervals for measurements must be consistently reported. Based on existing recommendations and expert consensus, these guidelines aim to provide investigators a framework for reporting studies of patients with possible AHFS. By providing these standardized reporting criteria, we hope to improve the interpretability of research in this challenging patient cohort and thus to improve patient care through better application of evidence-based medicine.

A working group of the Emergency Management and Research Group in Acute Heart Failure met in May 2007 to begin developing the reporting guidelines. Eight areas of importance were identified and assigned to working group members to develop initial recommendations based on existing guidelines:

1. Screening and recruitment

2. Demographics

3. Previous cardiac diagnosis, risk factors, medical history

4. Acute presentation (clinical characteristics)

5. Test reporting and observation care

6. Patient course including response to treatment

7. Outcomes

8. Follow-up period

The initial recommendations were modified and circulated to working group members before in-person meetings in October 2007, May 2008, October 2008, and May 2009. At these meetings, each proposed reporting element was discussed for incorporation as a core measure, supplemental measure, or dropped from further consideration.

The working draft was then distributed among the various stakeholders, including other members of Emergency Management and Research Group in Acute Heart Failure, for expansion and revision throughout 2010 and early 2011. Representatives of the Society of Academic Emergency Medicine, the American College of Emergency Physicians, the American Heart Association, the American College of Cardiology, the Heart Failure Society of America, the Society of Chest Pain Centers, and the Working Group of Acute Cardiac Care of the European Society of Cardiology were given the opportunity to review and revise the reporting guidelines. Once consensus was achieved, the Standardized Reporting Guidelines for Studies Evaluating Suspected Acute Heart Failure Syndromes in the Emergency Department were finalized for publication. The guidelines have been endorsed by Society of Academic Emergency Medicine, American College of Emergency Physicians, American Heart Association, Society of Chest Pain Centers, and the Working Group on Acute Cardiac Care of the European Society of Cardiology.

These guidelines emphasize the minimum information that should be reported and additional information that would be of benefit to report when presenting studies of the evaluation and management of AHFS. The structure is similar to recently introduced reporting guidelines for possible acute coronary syndromes (8). Where available, we have used the definition of data elements as provided by the American College of Cardiology, American Heart Association, European Society of Cardiology, Heart Failure Society of America, Society of Chest Pain Centers, or World Heart Federation (9). Where definitions do not exist or are insufficient to clarify ambiguity in reporting, new definitions have been provided.

Throughout the document, bolded items are identified as core components (Table 1), and these should be reported in all studies of the evaluation and management of AHFS. Supplemental items are not bolded but should be reported whenever possible. Core components represent the minimal amount of information necessary to compare and contrast studies and can be used by investigators to guide data collection and presentation of results. As well as facilitating the design of studies, peer reviewers evaluating manuscripts for publication may use these criteria to determine whether sufficient information is reported to allow readers to place the study in appropriate context and compare results with those of other publications. Clinicians may find it helpful to use the core criteria to determine whether reported populations are similar to the patients they treat and thus facilitate an evidence-based medicine approach to the acute evaluation and management of AHFS. Reporting AHFS studies in accordance with the guidelines will facilitate systematic review and meta-analysis, maximizing the impact of research on clinical practice.

• 1Screening and Recruitment

  Patients with AHFS are a heterogeneous population. The performance of diagnostic and prognostic interventions is dependent on the severity, prevalence, and pathophysiology of the disease in the study population, as well as comorbid conditions or alternative diagnoses. The methods of screening and recruiting subjects and study inclusion and exclusion criteria are key factors affecting these parameters and thus should be reported.

  • 1.1Specific ages for inclusion and exclusion
  • 1.2Procedure for identifying population to be screened
    • 1.2.1Signs, symptoms, or other criteria to prompt screening
    • 1.2.2Days and times of screening
    • 1.2.3Location of screening
  • 1.3Method of screening
    • 1.3.1By symptoms at presentation
      • 1.3.1.1The specific symptoms used for inclusion and exclusion
      • 1.3.1.2The time of onset and duration of symptoms used for inclusion and exclusion
    • 1.3.2By emergency department (ED) discharge/hospital admission diagnosis
    • 1.3.3By hospital discharge diagnosis
    • 1.3.4By diagnostic testing
      • 1.3.4.1Use of diagnostic testing (e.g., ordering echocardiography)
      • 1.3.4.2Results of diagnostic testing (e.g., elevated B-type natriuretic peptide [BNP])
    • 1.3.5By administration of medications (e.g., nitroglycerin, furosemide)
    • 1.3.6By pre-specified criteria (e.g., Framingham Criteria)
  • 1.4Account for patients screened and included and excluded from the study
    • 1.4.1Flow diagram to account for all patients
    • 1.4.2Report total ED census for participating institution(s)
    • 1.4.3Report ED volume of potential patients (e.g., total number of patients evaluated for AHFS)
    • 1.4.4Report volume of potential patients screened

• 2Demographics

  A description of the patients studied is important to understand the relevance of the study to specific populations to allow comparisons of different patient populations and for risk adjustments.

  • 2.1Sex
  • 2.2Age
  • 2.3Race, including method of determination (19):
    • 2.3.1American Indian or Alaska Native
    • 2.3.2Asian
    • 2.3.3Black or African American
    • 2.3.4African descendent
    • 2.3.5Native Hawaiian or other Pacific Islander
    • 2.3.6White
    • 2.3.7Other
    • 2.3.8Mixed race
  • 2.4Ethnicity
    • 2.4.1Hispanic
    • 2.4.2Non-Hispanic
  • 2.5Insurance status (refers to the primary payor)
    • 2.5.1Private refers to all private medical insurance.
    • 2.5.2Self-pay refers to no identifiable source of payment for medical bills.
    • 2.5.3Other refers to local, regional, or national government insurance program, charity, tax levy, or other source of payment
    • 2.5.4In the United States, differentiate Medicare from Medicaid
  • 2.6Mode of transport (means by which the patient arrived at the ED)
    • 2.6.1Self/family
    • 2.6.2Ground ambulance (basic, intermediate, or advanced)
    • 2.6.3Air ambulance
    • 2.6.4Other
  • 2.7Source of patients (place where patient resides at time of acute presentation)
    • 2.7.1Home
    • 2.7.2Other hospital facility
    • 2.7.3Extended care facility
    • 2.7.4Jail or prison
    • 2.7.5Other

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

  In the acute care setting, physicians frequently do not have access to detailed medical records and, therefore, must typically rely on patient self-report. In studies of AHFS conducted in the acute care setting, it is acceptable to rely on patient self-report of cardiac risk factors. However, the investigators must report the method of evaluation.

  • 3.1Hypertension
  • 3.2Family 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 younger than 65 years of age)
  • 3.3Diabetes mellitus (regardless of duration of disease or use of specific medications)
    • 3.3.1Type of diabetes mellitus treatment (diet, oral agents, insulin alone, or insulin with oral agents)
    • 3.3.2Year of onset or first diagnosis
  • 3.4Smoking
    • 3.4.1Current (within 1 month)
    • 3.4.2Recent (stopped between 1 month and 1 year before enrollment)
    • 3.4.3Former (stopped >1 year before enrollment)
    • 3.4.4Never smoker
  • 3.5Hypercholesterolemia or hyperlipidemia
  • 3.6Drug and alcohol use
    • 3.6.1Amount and duration
    • 3.6.2Results of toxicology testing
    • 3.6.3Current (within 1 month)
    • 3.6.4Recent (stopped between 1 month and 1 year before enrollment)
    • 3.6.5Former (stopped >1 year before enrollment)
  • 3.7Renal Insufficiency
    • 3.7.1Elevated creatinine
    • 3.7.2Reduced creatinine clearance or glomerular filtration rate (GFR); investigators must identify the method used to calculate these variables
    • 3.7.3Albuminuria
  • 3.8Presence of obesity
    • 3.8.1Body mass index
  • 3.9AMI. If the previous AMI is confirmed through medical record review and meets the European Society of Cardiology/American College of Cardiology/American Heart Association/World Heart Federation criteria (16), this should be noted. If the history of AMI cannot be confirmed to meet these criteria, then it should be recorded as “reported history of AMI.” If an alternative definition is used, this should be given.
  • 3.10Known cardiovascular disease
    • 3.10.1Heart failure (any previous episodes). If the presence of heart failure is documented in the medical record, this should be noted. Otherwise, it should be reported as “self-reported history of heart failure.”
      • 3.10.1.1Etiology of heart failure (if known)
      • 3.10.1.2Preserved or reduced systolic function and definition used
    • 3.10.2CAD. If the presence of CAD is documented in the medical record through objective criteria such as cardiac catheterization with significant stenosis, demonstrated electrocardiographic changes, perfusion defects, or wall motion abnormalities on exercise or pharmacological imaging studies, this should be noted (11). Otherwise, it should be recorded as “self-reported history of CAD.”
      • 3.10.2.1Revascularization (percutaneous coronary intervention, coronary artery bypass graft)
        • 3.10.2.1.1Type, number of grafts or stented vessels, year
    • 3.10.3Ventricular arrhythmias
      • 3.10.3.1Ventricular tachycardia resulting in symptoms or acute intervention
      • 3.10.3.2Ventricular fibrillation
    • 3.10.4Cardiac arrest
    • 3.10.5Atrial arrhythmias
      • 3.10.5.1Atrial fibrillation or flutter (20)
        • 3.10.5.1.1First detected
        • 3.10.5.1.2Paroxsymal
        • 3.10.5.1.3Persistent
    • 3.10.6Peripheral vascular disease
      • 3.10.6.1Peripheral arterial disease
      • 3.10.6.2Venous thromboembolic disease
    • 3.10.7Cerebrovascular events
    • 3.10.8Automatic internal cardiac defibrillator (ICD)
      • 3.10.8.1ICD only
      • 3.10.8.2Cardiac resynchronization therapy defibrillator (cardiac resynchronization therapy + ICD)
    • 3.10.9Pacemaker
      • 3.10.9.1Single chamber, dual chamber
      • 3.10.9.2Biventricular
    • 3.10.10Valvular disease
      • 3.10.10.1Native valve
      • 3.10.10.2Prosthetic valve
  • 3.11Previous objective assessments of cardiac function
    • 3.11.1Previous ejection fraction
      • 3.11.1.1Time interval from testing to ED visit
      • 3.11.1.2Method used to assess ejection fraction (e.g., echocardiography, catheterization, nuclear study)
    • 3.11.2Most recent known ejection fraction
    • 3.11.3Presence or absence of diastolic dysfunction, ventricular hypertrophy, regional wall motion abnormalities, valvular disease
    • 3.11.4Baseline (well or dry weight) BNP or N-terminal pro–BNP (NT-proBNP) values
  • 3.12Pulmonary disease
    • 3.12.1Asthma
    • 3.12.2Chronic obstructive pulmonary disease
    • 3.12.3Other
  • 3.13Home treatment
    • 3.13.1Current medications and definition used for current
      • 3.13.1.1Diuretics
      • 3.13.1.2Vasodilators (e.g., nitroglycerin, hydralazine)
      • 3.13.1.3Angiotensin-converting enzyme inhibitors
      • 3.13.1.4Angiotensin-receptor blockers
      • 3.13.1.5Inotropes
      • 3.13.1.6Aspirin
      • 3.13.1.7Adenosine diphosphate receptor inhibitors
      • 3.13.1.8Beta-blockers
      • 3.13.1.9Calcium channel blockers
        • 3.13.1.9.1Amlodipine
        • 3.13.1.9.2Other calcium channel blockers
      • 3.13.1.10Oral anticoagulants
        • 3.13.1.10.1Coumadin
        • 3.13.1.10.2Others
      • 3.13.1.11Aldosterone antagonists
      • 3.13.1.12Digoxin
      • 3.13.1.13Alpha antagonists
    • 3.13.2Contraindications to recommended treatments
    • 3.13.3Other home treatments

• 4Acute presentation

  The vast majority of patients with AHFS will have dyspnea as their chief symptom. A clear yet concise description of the degree and magnitude of breathlessness is therefore requisite for any investigation of AHFS, particularly those that involve stratification by severity of presentation or cross-population comparison. Quantification of symptom severity using tools such as the New York Heart Association classification system or relative Likert scales (21) is considered useful, but their validity may be limited by the subjectivity inherent to patient self-assessment. The recently proposed axis model should be taken into consideration, however its utility remains to be determined (23).

  • 4.1Dyspnea
    • 4.1.1Onset
      • 4.1.1.1Abrupt
      • 4.1.1.2Gradual
    • 4.1.2Character
      • 4.1.2.1Exertional only (mild)
      • 4.1.2.2At rest (moderate)
        • 4.1.2.2.1Without orthopnea
        • 4.1.2.2.2With orthopnea
        • 4.1.2.2.3Paroxysmal nocturnal
      • 4.1.2.3Respiratory distress (severe)
        • 4.1.2.3.1Needs immediate noninvasive ventilatory support
      • 4.1.2.4Respiratory failure
        • 4.1.2.4.1Needs immediate intubation
    • 4.1.3Comparison with baseline
    • 4.1.4Respiratory rate
    • 4.1.5Oxygen saturation
      • 4.1.5.1Indicate amount of supplemental oxygen currently administered
    • 4.1.6Signs of pulmonary congestion
      • 4.1.6.1Rales
        • 4.1.6.1.1Basilar only
        • 4.1.6.1.2Less than one-half lung field
        • 4.1.6.1.3More than one-half lung field
      • 4.1.6.2Wheeze
      • 4.1.6.3Accessory muscle use
  • 4.2Other signs and symptoms
    • 4.2.1Murmur (location, timing, and intensity)
    • 4.2.2Gallop (S₃, S₄)
      • 4.2.2.1Auscultation
      • 4.2.2.2Phonocardiography
    • 4.2.3Elevated jugular venous pressure
    • 4.2.4Peripheral edema
    • 4.2.5Hepatic congestion
    • 4.2.6Ascites
    • 4.2.7Anasarca
    • 4.2.8Weight at baseline
    • 4.2.9Weight gain
    • 4.2.10Height (for determination of GFR)
    • 4.2.11Fatigue
    • 4.2.12Syncope
    • 4.2.13Chest pain
    • 4.2.14Palpitations
  • 4.3Hemodynamic status. Hemodynamic status on presentation is a critical determinant of AHFS management (24) and has significant implications for clinical trial design. Uniform reporting of relevant parameters, therefore, is essential. Blood pressure is a particularly important variable to include and should be presented as needed to best characterize patient cohorts (7).
    • 4.3.1Blood pressure
      • 4.3.1.1Continuous integers
        • 4.3.1.1.1Systolic
        • 4.3.1.1.2Diastolic
      • 4.3.1.2Categorical (report cutoffs used)
        • 4.3.1.2.1Hypertensive
        • 4.3.1.2.2Normotensive
        • 4.3.1.2.3Hypotensive
        • 4.3.1.2.4Cardiogenic shock (hypotension with signs of hypoperfusion)
    • 4.3.2Heart rate
    • 4.3.3Other parameters (report if available along with method [invasive or noninvasive] by which they were obtained)
      • 4.3.3.1Cardiac index/output
      • 4.3.3.2Systemic vascular resistance
      • 4.3.3.3Stroke volume
      • 4.3.3.4Pulmonary capillary wedge pressure
  • 4.4Precipitating factors. These are the factors that are considered causative for the acute event rather than contributory to the underlying etiology of heart failure.
    • 4.4.1Uncontrolled hypertension
    • 4.4.2Acute cardiac ischemia/infarct
    • 4.4.3Arrhythmia
    • 4.4.4Noncompliance (e.g., medication, diet)
    • 4.4.5Toxicity (e.g., cocaine, amphetamines)
    • 4.4.6Acute valve problems (e.g., acute mitral regurgitation)
    • 4.4.7Myocarditis
    • 4.4.8High-output states (e.g., thiamine deficiency, thyrotoxicosis, sepsis, Paget's disease, severe anemia)
    • 4.4.9Systemic infections (e.g., pneumonia, urinary tract)
    • 4.4.10Pulmonary embolism
    • 4.4.11Development of comorbid states (e.g., renal failure, anemia, hypothyroidism)

• 5Test Reporting

  The tests used to evaluate patients with AHFS in the acute setting typically include the electrocardiogram (ECG), chest radiographs, and laboratory assays. Each of these should be reported with sufficient detail to enable accurate interpretation of the results. The lab result section (5.3) is meant to be an overview for both diagnostic and therapeutic studies. More detailed recommendations about biomarker reporting are available elsewhere (27).

  • 5.1ECG
    • 5.1.1Person(s) interpreting the ECGs
    • 5.1.2Timing of ECG relative to presentation
      • 5.1.2.1Presenting ECG
      • 5.1.2.2Out-of-hospital ECG
      • 5.1.2.3Serial in-hospital ECGs
    • 5.1.3Findings suggestive of acute coronary syndrome
      • 5.1.3.1Rate
      • 5.1.3.2Rhythm
      • 5.1.3.3Overall categorization of the ECG (31)
        • 5.1.3.3.1Normal
        • 5.1.3.3.2Nonspecific ST-T wave changes
        • 5.1.3.3.3Abnormal but not diagnostic of ischemia
        • 5.1.3.3.4Infarction or ischemia known to be old
        • 5.1.3.3.5Ischemia or infarction not known to be old
        • 5.1.3.3.6Consistent with AMI (ST-segment elevation or new left bundle branch block)
    • 5.1.4Dynamic ECG analysis
    • 5.1.5Presence of left bundle branch block
  • 5.2Chest radiograph
    • 5.2.1Procedure used for imaging
      • 5.2.1.1Anteroposterior (portable) technique
      • 5.2.1.2Posteroanterior and lateral technique
    • 5.2.2Person(s) interpreting the chest radiograph
    • 5.2.3Findings on the chest radiograph
      • 5.2.3.1Cardiomegaly
      • 5.2.3.2Pulmonary vascular redistribution
        • 5.2.3.2.1Mild
        • 5.2.3.2.2Moderate (e.g., Kerley B lines, fluid in fissure)
        • 5.2.3.2.3Severe (pulmonary edema)
      • 5.2.3.3Pleural effusion
      • 5.2.3.4Other major abnormality (e.g., pneumonia, mass)
  • 5.3Lab results
    • 5.3.1Timing of the lab specimen
      • 5.3.1.1Relative to symptom onset
      • 5.3.1.2Relative to clinical characteristics
    • 5.3.2Serum chemistry and blood analysis results, including the units of measurement
      • 5.3.2.1Blood urea nitrogen or urea
      • 5.3.2.2Creatinine
      • 5.3.2.3GFR
      • 5.3.2.4Sodium
      • 5.3.2.5Hemoglobin
      • 5.3.2.6Natriuretic peptides
        • 5.3.2.6.1Manufacturer name
        • 5.3.2.6.2BNP
        • 5.3.2.6.3NT-proBNP
      • 5.3.2.7Cardiac biomarkers
        • 5.3.2.7.1Assay type (high sensitivity or normal) and manufacturer
        • 5.3.2.7.2Established cutoffs for normal values and method by which they were derived
      • 5.3.2.8Other AHFS biomarkers may be considered
        • 5.3.2.8.1Midregional pro-atrial natriuretic peptide, adrenomedullin
    • 5.3.3Specimen collection and handling procedures
      • 5.3.3.1Detailed methods of sample handling and compliance with manufacturer recommendations
      • 5.3.3.2Phlebotomy tubes used (reagent), centrifugation, etc.
      • 5.3.3.3Assay performed individually or batched, run at time of blood draw or delayed
      • 5.3.3.4Location (e.g., at bedside, ED stat laboratory, offsite research laboratory)
      • 5.3.3.5Storage (e.g., sample frozen within how many hours of draw, flash frozen on liquid nitrogen, freezing temperature, length of time frozen)
    • 5.3.4Marker performance relative to defined outcomes. This is a core requirement if the primary objective of the investigation is assessment of marker performance; otherwise, it is a supplemental criterion.
      • 5.3.4.1Sensitivity, specificity, positive predictive value, negative predictive value, and likelihood ratios with 95% confidence intervals
      • 5.3.4.2Receiver-operating characteristic curve data
        • 5.3.4.2.1Optimal operating point and how defined
        • 5.3.4.2.2Interval likelihood ratios
    • 5.3.5Relevant confounders for the assays being used. This is a core requirement if the primary objective of the investigation is assessment of marker performance; otherwise, it is a supplemental criterion.
      • 5.3.5.1Proportion of patients with renal insufficiency
      • 5.3.5.2Body mass index for natriuretic peptide testing

• 6Patient Course

  Patient course can be quite variable for patients presenting with AHFS. Medications administered as well as the timing of interventions may have a significant impact on patient course and disposition. Medications and interventions should be reported according to whether they were given early in the patient course or as secondary treatment after initial therapy had not produced an adequate response. Further categorization is also needed to delineate whether the medication was given as a primary treatment or a secondary (preventive) measure.

  • 6.1ED and hospital course
    • 6.1.1ED disposition
      • 6.1.1.1Discharge
      • 6.1.1.2Observation unit admission
      • 6.1.1.3Inpatient admission
      • 6.1.1.4Left ED against medical advice
      • 6.1.1.5Died in ED
      • 6.1.1.6Transferred
    • 6.1.2Observation unit management
      • 6.1.2.1System
        • 6.1.2.1.1Virtual unit or defined space
        • 6.1.2.1.2Level of monitoring (i.e., telemetry)
        • 6.1.2.1.3Number of beds
        • 6.1.2.1.4Eligibility criteria for unit admission
        • 6.1.2.1.5Heart failure specific or general
      • 6.1.2.2Personnel
        • 6.1.2.2.1The training characteristics of personnel primarily responsible for the patient undergoing observation care
      • 6.1.2.3Treatment protocols
        • 6.1.2.3.1Therapeutic protocols or algorithms in use for patients undergoing observation care
        • 6.1.2.3.2Rate of protocol compliance
      • 6.1.2.4The length of time under observation status
      • 6.1.2.5Disposition
        • 6.1.2.5.1Home
          • 6.1.2.5.1.1Discharge criteria, including any consultation requirements
        • 6.1.2.5.2Inpatient admission
        • 6.1.2.5.3Left observation unit against medical advice
        • 6.1.2.5.4Died in observation unit
    • 6.1.3Inpatient admission
      • 6.1.3.1Intensive care unit/cardiac care unit
      • 6.1.3.2Telemetry
      • 6.1.3.3Unmonitored floor bed
      • 6.1.3.4Transferred
      • 6.1.3.2Inpatient disposition
        • 6.1.3.2.1Home
        • 6.1.3.2.2Died in hospital
        • 6.1.3.2.3Hospice
        • 6.1.3.2.4Transferred to another hospital
        • 6.1.3.2.5Extended care facility
  • 6.2Therapeutics and interventions
    • 6.2.1Pharmacological therapeutics
      • 6.2.1.1Aspirin
      • 6.2.1.2Vasoactives
        • 6.2.1.2.1Nitroglycerin and route (intravenous, topical, sublingual)
        • 6.2.1.2.2Nitroprusside
        • 6.2.1.2.3Nesiritide
        • 6.2.1.2.4Phenylephrine
        • 6.2.1.2.5Norepinephrine
        • 6.2.1.2.6Epinephrine
        • 6.2.1.2.7Dopamine
      • 6.2.1.3Inotropic agents
        • 6.2.1.3.1Dobutamine
        • 6.2.1.3.2Milrinone
        • 6.2.1.3.3Levosimendan
      • 6.2.1.4Diuretics
        • 6.2.1.4.1Name of diuretic
        • 6.2.1.4.2Dose
        • 6.2.1.4.3Mode of administration (oral, intravenous bolus, or continuous infusion)
      • 6.2.1.5Beta-blockers
      • 6.2.1.6Angiotensin-converting enzyme inhibitors
      • 6.2.1.7Angiotensin receptor blockers
      • 6.2.1.8Aldosterone antagonists
      • 6.2.1.9Morphine
      • 6.2.1.10Atropine
      • 6.2.1.11Antiarrhythmic (e.g., adenosine, amiodarone)
      • 6.2.1.12Antithrombins (e.g., unfractionated heparin, low molecular weight heparin, direct thrombin inhibitors)
      • 6.2.1.13Others
    • 6.2.2Nonpharmacological therapeutics
    • 6.2.3Interventions
      • 6.2.3.1Primary
      • 6.2.3.2Secondary/preventive
      • 6.2.3.3Noninvasive ventilation (continuous positive airway pressure/bilevel positive airway pressure)
      • 6.2.3.4Intubation
      • 6.2.3.5Electrical cardioversion
      • 6.2.3.6Defibrillation
      • 6.2.3.7Right heart catheter, both as a 1-time procedure to obtain diagnostic data and a pulmonary artery catheter to follow response to therapy
      • 6.2.3.8Left heart catheterization
      • 6.2.3.9Single-chamber pacemaker
      • 6.2.3.10Biventricular pacemaker
      • 6.2.3.11Implantable cardioverter-defibrillator
      • 6.2.3.12Percutaneous coronary intervention
      • 6.2.3.13Balloon pump
      • 6.2.3.14Ultrafiltration
      • 6.2.3.15Percutaneous cardiopulmonary support
      • 6.2.3.16Ventricular assist device
      • 6.2.3.17Transplantation
      • 6.2.3.18Others
    • 6.2.4Timing of therapy or intervention relative to presentation
      • 6.2.4.1Pre-hospital
      • 6.2.4.2Early (within first 12 to 24 h)
      • 6.2.4.3Late (after first 24 h)
    • 6.2.5Route of administration of therapy
      • 6.2.5.1Oral
      • 6.2.5.2Sublingual
      • 6.2.5.3Intravenous
      • 6.2.5.4Intramuscular/subcutaneous
    • 6.2.6Endotracheal tube
    • 6.2.7Dose of therapy
  • 6.3Response to treatment
    • 6.3.1Total urinary output
    • 6.3.2Weight change during hospitalization
    • 6.3.3Total input/output during hospitalization
    • 6.3.4Laboratory values before discharge
      • 6.3.4.1Blood urea nitrogen
      • 6.3.4.2Creatinine
      • 6.3.4.3GFR
      • 6.3.4.4Sodium
      • 6.3.4.5Potassium
      • 6.3.4.6BNP/NT-proBNP
      • 6.3.4.7Hemoglobin
    • 6.3.5Hemodynamic values before discharge
      • 6.3.5.1Blood pressure (systolic and diastolic)
      • 6.3.5.2Heart rate
    • 6.3.6Respiratory status before discharge
      • 6.3.6.1Respiratory rate
      • 6.3.6.2Oxygen saturation including amount of supplemental oxygen
    • 6.3.7Jugular venous pressure before discharge

• 7Outcomes

  Hospitalization for AHFS is a significant marker for post-discharge events (i.e., rehospitalization or mortality). However, very few studies have been conducted that looked at short-term outcomes based on acute management. Development and establishment of short-term outcome goals or targets is a current area of investigational research, balancing the needs of clinicians, investigators, and regulatory agencies. For studies of the management and evaluation of AHFS, therefore, the definition of outcomes appropriate to the study's purpose should be reported.

  • 7.1Safety and efficacy endpoints
    • 7.1.1Mortality
      • 7.1.1.1Days from presentation (e.g., 5 days, 7 days, 30 days, 180 days)
    • 7.1.2Morbidity
      • 7.1.2.1Worsening heart failure (as defined for the study)
      • 7.1.2.2Days alive and out of hospital
    • 7.1.3Resource utilization
      • 7.1.3.1Lengths of stay
      • 7.1.3.2Costs
      • 7.1.3.3Recidivism
  • 7.2Organ protection/preservation/improvement
    • 7.2.1Cardiac
      • 7.2.1.1Biomarkers
      • 7.2.1.2ECG
      • 7.2.1.3Echocardiographic indices
      • 7.2.1.4Hemodynamic (specify invasive or noninvasive)
      • 7.2.1.5Serious arrhythmia (atrial fibrillation/flutter, ventricular tachycardia, ventricular fibrillation)
    • 7.2.2Renal
      • 7.2.2.1Blood urea nitrogen
      • 7.2.2.2Creatinine
      • 7.2.2.3Creatinine clearance or GFR (specify method of calculation if estimated)
      • 7.2.2.4Novel biomarkers
      • 7.2.2.5Other
    • 7.2.3Stroke
      • 7.2.3.1Hemorrhagic
      • 7.2.3.2Nonhemorrhagic
  • 7.3Interventions
    • 7.3.1Pharmacological
      • 7.3.1.1Need for rescue therapy (define)
    • 7.3.2Surgical
    • 7.3.3Procedural
    • 7.3.4Airway management (endotracheal tube, non-invasive ventilation)
  • 7.4Symptoms and signs (distinguish between physician assessed and patient assessed)
    • 7.4.1Dyspnea
    • 7.4.2Jugular venous pressure
    • 7.4.3Rales
    • 7.4.4Edema
    • 7.4.5Other
  • 7.5Quality of life
    • 7.5.1Quality of life questionnaires (e.g., Kansas City Cardiomyopathy Questionnaire)
  • 7.6Response to therapy
    • 7.6.1Body weight
    • 7.6.2Urine output
    • 7.6.3Functional capacity (e.g., 6-min walk test)
    • 7.6.4Other
  • 7.7Composite endpoints: each component needs to be specifically defined
    • 7.7.1Global rank: events prioritized by importance (e.g., death > rehospitalization > biomarker elevation); this method provides an opportunity for more subjects to experience an “endpoint”
    • 7.7.2Breakdown of individual endpoints of composite measure

• 8Follow-up

  There are limited data available regarding a recommended time to follow-up after an ED visit or hospitalization for AHFS (13). Access to follow-up care may vary depending on several factors including availability of heart failure specialty or primary care clinics and the patient's insurance status. Poor outpatient follow-up may exert considerable confounding on research outcomes. Patients with an inability to obtain appropriate medications or clinical follow-up may experience adverse events independent of the research intervention being applied. Both clinical and research follow-up should therefore be reported.

  • 8.1Duration of follow-up
    • 8.1.1Start point of follow-up period
      • 8.1.1.1Presentation
      • 8.1.1.2In-hospital/treatment events
      • 8.1.1.3Discharge
  • 8.2Clinical follow-up and timing
    • 8.2.1Access to and attendance at care providers during the follow-up period
      • 8.2.1.1Primary care
      • 8.2.1.2Cardiologist
      • 8.2.1.3Heart failure specialty clinic
  • 8.3Research follow-up
    • 8.3.1Methodology
      • 8.3.1.1Telephone or in person
      • 8.3.1.2Patient or proxy
      • 8.3.1.3Use of medical record review
        • 8.3.1.3.1Primary follow-up method
        • 8.3.1.3.2Supplementary to contact
        • 8.3.1.3.3Confirmatory of reported events
      • 8.3.1.4Insurance/claims data
      • 8.3.1.5National registry/Social Security Death Index
    • 8.3.2Proportion lost to follow-up