Download Measuring results that matter Heart Failure

HEART FAILURE
DATA COLLECTION
REFERENCE GUIDE
Version 1.1
Revised: October 13th, 2016
Measuring
results
that matter
Physical
Exertion
Heart Failure
We are thrilled that you are interested in measuring outcomes for your heart failure patients according to ICHOM
standards. It is our hope that this Reference Guide will facilitate the process of implementing our Standard Set
and ensure the collection of comparable data for global benchmarking and learning.
© 2016 ICHOM. All rights reserved. When using this set of outcomes, or quoting therefrom, in any way, we solely require that you always
make a reference to ICHOM as the source so that this organization can continue its work to define more standard outcome sets.
DATA COLLECTION REFERENCE GUIDE
HEART FAILURE | 1
Introducing ICHOM and the Reference Guide
ICHOM brings together patient representatives, clinician leaders, and registry leaders from all over the world to
develop Standard Sets, comprehensive yet parsimonious sets of outcomes and case-mix variables for specific
medical conditions that we recommend that all providers track.
Each Standard Set focuses on patient-centered results, and provides an internationally-agreed upon method for
measuring each of these outcomes. We do this because we believe that standardized outcomes measurement
will open new possibilities to compare performance globally, allow clinicians to learn from each other, and rapidly
improve the care we provide our patients.
Our Standard Sets include baseline conditions and risk factors to enable meaningful case-mix adjustment
globally, ensuring that comparisons of outcomes will take into account the differences in patient populations
across not just providers, but also countries and regions. We also include high-level treatment variables to allow
stratification of outcomes by major treatment types. A comprehensive data dictionary, as well as scoring guides
for patient-reported outcomes, is included in the appendix.
Working Group Members for Heart Failure
The following individuals dedicated both time and expertise to develop the ICHOM Standard Set for Heart
Failure in partnership with ICHOM, under the leadership of Dr. Theresa McDonagh, Professor of Heart Failure at
Kings College Hospital in London and Clinical Lead for the National Heart Failure Audit in the United Kingdom.
Australia
John Beltrame
Tom Marwick
Christopher Reid
Brazil
Sabrina Bernardez
Salvador Paiva
England
Suzanna Hardman
Tina Kinsella
Mike Knapton
Theresa McDonagh
Hugh McIntyre
Richard Mindham
Vicky Parker
Canada
Daniel Burns
Greece
Gerasimos Filippatos
DATA COLLECTION REFERENCE GUIDE
Netherlands
Arno Hoes
Luuk Otterspoor
Singapore
Carolyn Lam Su Ping
South Africa
Karen Sliwa
Spain
Marisa Crespo-Leiro
Sweden
Hans Persson
United States
Mariell Jessup
Frederick Masoudi
Lynne Stevenson
Wales
Stephen Hutchison
HEART FAILURE | 2
Supporting Organizations
The Heart Failure Standard Set is made possible only through the support of the following organizations:
Thank you.
Treatment Approaches Covered for Heart Failure
For Heart Failure, the following treatment approaches (or interventions) are covered by our Standard Set:
Treatment
Approaches
DATA COLLECTION REFERENCE GUIDE
Pharmacotherapy | Invasive Therapy | Rehabilitation
HEART FAILURE | 3
ICHOM
Standard Set for Heart Failure
Case-Mix
Variables
Patient Population Measure Supporting Information Timing Suggested Data Sources Demographic Factors Age Sex All patients Ethnicity Baseline health status Hypertension Diabetes Renal dysfunction Smoking status (current or in past year) Alcohol use (>1 drink a day) All patients Prior MI Atrial fibrillation Chronic lung disease Body mass index Ejection Fraction Diagnostic categories Treatment
Variables
Patient Population Measure All patients Patients receiving device Patients receiving cardiac surgery Patients receiving rehabilitation Medications initiated Date of birth Sex at birth Note that regulations on reporting ethnicity may differ per country At index event for HF Administrative data At index event for HF Clinician-­‐reported Yes/No Need for dialysis Yes/No Oxygen dependency Height and weight Determined by echocardiogram N/A Supporting Information Timing Suggested Data Sources Medication list Device procedure type Device type (ICD or CRT) Cardiac surgery procedure type CABG, CABG+valve, CABG/valve+Other Measure initiated Rehabilitation DATA COLLECTION REFERENCE GUIDE
Tracked ongoing Clinician-­‐reported HEART FAILURE | 4
Outcomes
Patient Population Measure Supporting Information Timing Suggested Data Sources Functional All patients Maximum level of physical exertion Symptom control: SOB Symptom control: Fatigue and tiredness Living independently/self-­‐
care Employment Peripheral oedema Symptom control: Disturbed sleep Tracked with KCCQ-­‐12 and NYHA Tracked with PROMIS and KCCQ-­‐12 Patient and clinician-­‐reported Tracked ongoing except at acute admissions Patient-­‐reported Tracked with KCCQ-­‐12 Clinician-­‐reported Psychosocial All patients Health-­‐related Quality Tracked with KCCQ-­‐12 of Life Depression and Tracked with PHQ-­‐2 anxiety Confidence/self-­‐
Tracked with KCCQ-­‐12 esteem Tracked ongoing except at acute admissions Patient-­‐reported Burden of care All patients Medication side-­‐
effects Financial burden Complications of treatment Number of hospital appointments Number of hospital readmissions Yes/No Yes/No Due to device, medication and/or hospitalization N/A N/A Length of stay Date of admission and discharge Mortality N/A Clinician-­‐reported Tracked ongoing except at acute admissions Administrative data Survival All patients Tracked ongoing Administrative data DATA COLLECTION REFERENCE GUIDE
HEART FAILURE | 5
Measurement Timeline and Sample Questionnaires
The following timeline illustrates when Standard Set variables should be collected from patients, clinicians, and
administrative sources. Links to the sample questionnaires may be found in the legend below.
TO
30 days
post-index
event
6 months
post-index
event
Acute
30 days
admission
post(including
discharge
complications)
6 months
following last
hospital
admission
(reset clock)
6-monthly
for life
TO Index event for Heart (first clinical encounter since entry to the the Set or new Diagnosis)
Baseline characteristics (link)
Age 18-22 PROMs (patient reported outcome measures) (link)
(End of
Clinician reported outcomes (link)
Treatment)
DATA COLLECTION REFERENCE GUIDE
HEART FAILURE | 6
Collecting Patient-Reported Outcome Measures
Heart Failure Survey Used
Licensing Information
Scoring Guide
KCCQ-12 – Kansas City
Cardiomyopathy QuestionnaireShort Version
You can obtain a license to use this
instrument at your institution by
visiting http://cvoutcomes.org/
licenses
See link on the left
The NYHA is free for all health care
NYHA – New York Heart Association
organizations, and a license is not
Functional Classification
needed.
PROMIS – Patient-Reported
Outcome Measurement
Information System
Patient Health Questionnaire
(PHQ-2)
The PROMIS is free for all health
care organizations, and a license is
not needed. For more information, See link on the left
please visit http://www.nihpromis.
org/faqs
The PHQ-2 is free for all health care The scoring guide may be found at
organizations, and a license is not
http://www.phqscreeners.com/
needed.
instructions/instructions.pdf
The Growing ICHOM Community
By implementing the ICHOM Standard Sets, you become part of an expanding, international community of
innovative health care providers dedicated to improving value for patients. To learn more about how ICHOM can
assist your organization in implementing outcome measurement, contact us at [email protected], or visit
http://www.ichom.org/measure.
DATA COLLECTION REFERENCE GUIDE
HEART FAILURE | 7
Appendix
DATA COLLECTION REFERENCE GUIDE
HEART FAILURE | 8
Introduction to the Data Dictionary
This data dictionary is designed to help you measure the ICHOM Heart Failure Standard Set as consistently as
possible with the Working Group recommendation. ICHOM is actively preparing for benchmarking efforts based
on this data, and all data submitted for comparisons will need to be transformed into the following data structure
if not already structured as such. We are happy to provide an Excel version of this data dictionary for technical
use.
Please timestamp all variables. Some Standard Set variables are collected at multiple timepoints, and we will
ask you to submit these variables in a concatenated VARIABLEID_TIMESTAMP form for future analyses. For
example, VARIABLEID_BASE (baseline); VARIABLEID_6MO (6 month follow-up); VARIABLEID_1YR (1 year
follow-up), etc.
Case-Mix Variables
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
CASE-MIX VARIABLES
N/A
Patient ID
Indicate the patient's medical record number
This number will not be shared with ICHOM. In the case patient-level data is
submitted to ICHOM for benchmarking or research purposes, a separate ICHOM
Patient Identifier will be created and cross-linking between the ICHOM Patient
Identifier and the medical record number will only be known at the treating
institution
All patients
At index event for HF
Administrative data
Numerical
According to institution
Demographic Factors
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
DATA COLLECTION REFERENCE GUIDE
AGE
Age
What is your date of birth?
N/A
All patients
At index event for HF
Administrative data
Date by DD/MM/YYYY
DD/MM/YYYY
SEX
Sex
Please indicate your sex at birth
N/A
All patients
At index event for HF
Administrative data
Single answer
1 = Male
HEART FAILURE | 9
CASE-MIX VARIABLES
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
2 = Female
ETNIC
Ethnicity
Varies by country and should be determined by country (not for cross country
comparison)
This response option is based upon the U.S. Standards for the Classification of
Federal Data on Race and Ethnicity, and reflects standards in the U.S. Please adapt
questions according to your country’s guidelines.
This is based upon the U.S. Standards for the Classification of Federal Data on
Race and Ethnicity, and reflects standards in the U.S. Please adapt questions
according to your country’s guidelines
All patients
At index event for HF
Clinician-reported
Single answer
0 = American Indian or Alaska Native
1 = Asian
2 = Black or African American
3 = Hispanic or Latino
4 = Native Hawaiian or Other Pacific Islander
5 = White
Baseline Health Status
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
DATA COLLECTION REFERENCE GUIDE
AFIB
Atrial fibrillation
Have you ever been told by your doctor that you have atrial fibrillation?
Item is phrased as a patient reported measure. However, if the patient is unable to
answer, this information can be abstracted from the medical records.
All patients
At index event for HF
Clinician-reported
Single answer
0 = No
1 = Yes
999 = Unknown
PRIORMI
Prior MI
Have you ever been told by your doctor that you've had a heart attack (this is
sometimes called a myocardial infarction, or MI)?
Item is phrased as a patient reported measure. However, if the patient is unable to
answer, this information can be abstracted from the medical records.
All patients
At index event for HF
Clinician-reported
Single answer
0 = No
1 = Yes
999 = Unknown
SMOKE
Smoking status
Do you currently smoke, or have you smoked cigarettes or tobacco over the past
year?
Smoking status (of cigarettes or tobacco). Item is phrased as a patient reported
measure. However, if the patient is unable to answer, this information can be
abstracted from the medical records.
All patients
At index event for HF
HEART FAILURE | 10
CASE-MIX VARIABLES
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
DATA COLLECTION REFERENCE GUIDE
Clinician-reported
Single answer
0 = No
1 = Yes
999 = Unknown
ALCOHOL
Alcohol use
Do you drink more than one alcoholic drink a day?
One standard alcoholic drink is:
12 ounces of regular beer (about 5% alcohol)
5 ounces of wine (about 12% alcohol)
1.5 ounces of distilled spirits (about 40% alcohol)
Item is phrased as a patient reported measure. However, if the patient is unable to
answer, this information can be abstracted from the medical records.
All patients
At index event for HF
Clinician-reported
Single answer
0 = No
1 = Yes
999 = Unknown
HYPERTEN
Past medical history: Hypertension
Indicate whether the patient has a documented history of hypertension diagnosed
and treated with medication and/or diet and/or exercise
N/A
All patients
At index event for HF
Clinician-reported
Single answer
0 = No
1 = Yes
999 = Unknown
HEIGHT
Height
How tall are you?
Height and weight are used to calculate BMI
All patients
At index event for HF
Patient-reported or clinical
Numeric value
Numeric value of height in metric or imperial system
HEIGHTUNIT
Height units
Units
N/A
All patients
At index event for HF
Patient-reported or clinical
Single answer
1 = cm
2 = in
WEIGHT
Weight
How much do you weigh?
Height and weight are used to calculate BMI
All patients
HEART FAILURE | 11
CASE-MIX VARIABLES
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
At index event for HF
Patient-reported or clinical
Numeric value
Numeric value of weight in metric or imperial system
WEIGHTUNIT
Weight units
Units
N/A
All patients
At index event for HF
Patient-reported or clinical
Single answer
1 = kg
2 = lbs
Variable ID: DIAB
Variable: Diabetes mellitus
Definition: Have you ever been told by your doctor that you have diabetes?
Supporting Definition: Item is phrased as a patient reported measure. However, if the patient is unable to
answer, this information can be abstracted from the medical records.
Inclusion Criteria: All patients
Timing: At index event for HF
Reporting Source: Clinician-reported
Type: Single answer
Response Options: 0 = No
1 = Yes
Variable ID: CHRONLD
Variable: Past medical history: Chronic lung disease
Definition: Indicate whether the patient has a chronic lung disease
Supporting Definition: Including but not limited to COPD and asthma
Inclusion Criteria: All patients
Timing: At index event for HF
Reporting Source: Clinician-reported
Type: Single answer
Response Options: 0 = No
1 = Yes, during index hospitalization
2 = Yes, after discharge but within 30 days of procedure
Variable ID: RENDYS
Variable: Renal dysfunction
Definition: Indicate whether the patient has a diagnosis of renal dysfunction
Supporting Definition: Renal dysfunction is the documented history of AKI and/or Increase in serum
creatinine by ≥ 0.3 mg/dl (≥ 26.5 l mol/l) within 48 hours; and/or increase in serum
creatinine to ≥ 1.5 times baseline, which is known or presumed to have occurred
within the prior 7 days; and/or urine volume < 0.5 ml/kg/h for 6 hours; and/or new
requirement for dialysis
Inclusion Criteria: All patients
Timing: At index event for HF
Reporting Source: Clinician-reported
Type: Single answer
Response Options: 0 = No
1 = Yes, during index hospitalization
2 = Yes, after discharge but within 30 days of procedure
Variable ID: EJECFRAC
Variable: Ejection Fraction
Definition: If echocardiogram performed, please state range of patient’s ejection fraction:
Supporting Definition: N/A
Inclusion Criteria: All patients
DATA COLLECTION REFERENCE
HEART FAILURE | 12
Timing:GUIDEAt index event for HF
CASE-MIX VARIABLES
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
DATA COLLECTION REFERENCE GUIDE
Clinician-reported
Single answer
1 = <30%
2 = 30-40%
3 = 40-50%
4 = >50%
DIAGCAT
Diagnostic categories
Please indicate diagnostic categories:
N/A
All patients
At index event for HF
Clinician-reported
Multiple answers
1 = Ischaemic
2 = Hypertensive
3 = Valvular
4 = Familial
5 = Peripartum
6 = Myocarditis/Inflammatory
7 = Infiltrative
8 = Stress/Takotsubo
9 = Idiopathic/Other
10 = Chagas' Disease
HEART FAILURE | 13
Treatment Variables
TREATMENT VARIABLES
Treatment Variables
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
PHARMACOTHERAPY
Medications initiated
Indicate medications initiated
N/A
All patients
Tracked ongoing
Clinician-reported
Free text
N/A
DEVPROCEDURETYPE
Device procedure type
Indicate the device type
N/A
Patients receiving device
Tracked ongoing
Clinician-reported
Single answer
1 = ICD
2 = CRT
3 = Both
CABGPROCEDURETYPE
Cardiac surgery procedure type
Indicate the cardiac surgery procedure type
CABG + other includes but is not limited to: placement of ventricular assist devices,
non-cardiac procedures
Patients receiving cardiac surgery
Tracked ongoing
Clinician-reported
Single answer
1 = CABG only
2 = Valve
3 = CABG + valve
4 = CABG/valve + other
PALLIATIVE
Palliative measure
Is the patient for end-of life care?
Referred to palliative care services, down-titration of drugs, switching off ICDs. If
patient is already on end-of-life care pathway, exclude.
Patients receiving palliative care
Date palliation initiated
Clinician-reported
Single answer
0 = No
1 = Yes
2 = Unknown
REHAB
Cardiac rehabilitation
Cardiac rehabilitation initiated
Includes medically-supervised exercise training, education on healthy living, and
counselling to reduce stress.
All patients
Tracked ongoing
Clinician-reported
DATA COLLECTION REFERENCE GUIDE
HEART FAILURE | 14
TREATMENT VARIABLES
Type:
Response Options:
DATA COLLECTION REFERENCE GUIDE
Single answer
0 = No 1 = Yes
HEART FAILURE | 15
Outcomes
OUTCOMES
Degree of Health
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
DATA COLLECTION REFERENCE GUIDE
KCCQ12_Qo1a
Question 1a of KCCQ-12
Heart failure affects different people in different ways. Some feel shortness of
breath while others feel fatigue. Please indicate how much you are limited by heart
failure (shortness of breath or fatigue) in your ability to do the following activities
over the past 2 weeks.
a. Showering/bathing
N/A
All patients
Tracked ongoing except at acute admissions
Patient-reported
Single answer
0 = Extremely limited
1 = Quite a bit limited
2 = Moderately limited
3 = Slightly limited
4 = Not at all limited
5 = Limited for other reasons or did not do the activity
KCCQ12_Qo1b
Question 1b of KCCQ-12
b. Walking 1 block on level ground
N/A
All patients
Tracked ongoing except at acute admissions
Patient-reported
Single answer
0 = Extremely limited
1 = Quite a bit limited
2 = Moderately limited
3 = Slightly limited
4 = Not at all limited
5 = Limited for other reasons or did not do the activity
KCCQ12_Qo1c
Question 1c of KCCQ-12
c. Hurrying or jogging (as if to catch a bus)
N/A
All patients
Tracked ongoing except at acute admissions
Patient-reported
Single answer
0 = Extremely limited
1 = Quite a bit limited
2 = Moderately limited
3 = Slightly limited
4 = Not at all limited
5 = Limited for other reasons or did not do the activity
KCCQ12_Qo2
Question 2 of KCCQ-12
Over the past 2 weeks, how many times did you have swelling in your feet, ankles
or legs when you woke up in the morning?
N/A
All patients
Tracked ongoing except at acute admissions
HEART FAILURE | 16
OUTCOMES
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
DATA COLLECTION REFERENCE GUIDE
Patient-reported
Single answer
0 = Every morning
1 = 3 or more times per week but not every day
2 = 1-2 times per week
3 = Less than once a week
4 = Never over the past 2 weeks
KCCQ12_Qo3
Question 3 of KCCQ-12
Over the past 2 weeks, on average, how many times has fatigue limited your ability
to do what you wanted?
N/A
All patients
Tracked ongoing except at acute admissions
Patient-reported
Single answer
0 = All of the time
1 = Several times per day
2 = At least once a day
3 = 3 or more times per week but not every day
4 = 1-2 times per week
5 = Less than once a week
6 = Never over the past 2 weeks
KCCQ12_Qo4
Question 4 of KCCQ-12
Over the past 2 weeks, on average, how many times has shortness of breath
limited your ability to do what you wanted?
N/A
All patients
Tracked ongoing except at acute admissions
Patient-reported
Single answer
0 = All of the time
1 = Several times per day
2 = At least once a day
3 = 3 or more times per week but not every day
4 = 1-2 times per week
5 = Less than once a week
6 = Never over the past 2 weeks
KCCQ12_Qo5
Question 5 of KCCQ-12
Over the past 2 weeks, on average, how many times have you been forced to sleep
sitting up in a chair or with at least 3 pillows to prop you up because of shortness of
breath?
N/A
All patients
Tracked ongoing except at acute admissions
Patient-reported
Single answer
0 = Every night
1 = 3 or more times per week but not every day
2 = 1-2 times per week
3 = Less than once a week
4 = Never over the past 2 weeks
KCCQ12_Qo6
Question 6 of KCCQ-12
Over the past 2 weeks, how much has your heart failure limited your enjoyment of
HEART FAILURE | 17
OUTCOMES
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
DATA COLLECTION REFERENCE GUIDE
life?
N/A
All patients
Tracked ongoing except at acute admissions
Patient-reported
Single answer
0 = It has extremely limited my enjoyment of life
1 = It has limited my enjoyment of life quite a bit
2 = It has moderately limited my enjoyment of life
3 = It has slightly limited my enjoyment of life
4 = It has not limited my enjoyment of life at all
KCCQ12_Qo7
Question 7 of KCCQ-12
If you had to spend the rest of your life with your heart failure the way it is right
now, how would you feel about this?
N/A
All patients
Tracked ongoing except at acute admissions
Patient-reported
Single answer
0 = Not at all satisfied
1 = Mostly dissatisfied
2 = Somewhat satisfied
3 = Mostly satisfied
4 = Completely satisfied
KCCQ12_Qo8a
Question 8a of KCCQ-12
How much does your heart failure affect your lifestyle? Please indicate how your
heart failure may have limited your participation in the following activities over the
past 2 weeks.
a. Hobbies, recreational, activities
N/A
All patients
Tracked ongoing except at acute admissions
Patient-reported
Single answer
0 = Severely limited
1 = Limited quite a bit
2 = Moderately limited
3 = Slightly limited
4 = Did not limit at all
5 = Does not apply or did not do for other reasons
KCCQ12_Qo8b
Question 8b of KCCQ-12
b. Working or doing household chores
N/A
All patients
Tracked ongoing except at acute admissions
Patient-reported
Single answer
0 = Severely limited
1 = Limited quite a bit
2 = Moderately limited
3 = Slightly limited
4 = Did not limit at all
5 = Does not apply or did not do for other reasons
HEART FAILURE | 18
OUTCOMES
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
KCCQ12_Qo8c
Question 8c of KCCQ-12
c. Visiting family or friends out of your home
N/A
All patients
Tracked ongoing except at acute admissions
Patient-reported
Single answer
0 = Severely limited
1 = Limited quite a bit
2 = Moderately limited
3 = Slightly limited
4 = Did not limit at all
5 = Does not apply or did not do for other reasons
NYHA_Q01
Question 1 of NYHA
How severe are the patient's symptoms?
N/A
All patients
Tracked ongoing except at acute admissions
Clinician-reported
Single answer
0 = Class I: No limitation of physical activity. Ordinary physical activity does not
cause undue fatigue, palpitation, dyspnea (shortness of breath).
1 = Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary
physical activity results in fatigue, palpitation, dyspnea (shortness of breath).
2 = Class III: Marked limitation of physical activity. Comfortable at rest. Less than
ordinary activity causes fatigue, palpitation, or dyspnea.
3 = Class IV: Unable to carry on any physical activity without discomfort.
Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort
increases.
NYHA_Q02
Question 2 of NYHA
What level of problems does the healthcare provider see?
N/A
All patients
Tracked ongoing except at acute admissions
Clinician-reported
Single answer
0 = Class A: No objective evidence of cardiovascular disease. No symptoms and no
limitation in ordinary physical activity.
1 = Class B: Objective evidence of minimal cardiovascular disease. Mild symptoms
and slight limitation during ordinary activity. Comfortable at rest.
2 = Class C: Objective evidence of moderately severe cardiovascular disease.
Marked limitation in activity due to symptoms, even during less-than-ordinary
activity. Comfortable only at rest.
3 = Class D: Objective evidence of severe cardiovascular disease. Severe limitation.
Experiences symptoms even while at rest.
PROMIS_Q01
Question 1 of PROMIS
How much difficulty do you have doing your daily physical activities, because of
your health?
N/A
All patients
Tracked ongoing except at acute admissions
Patient-reported
Single answer
DATA COLLECTION REFERENCE GUIDE
HEART FAILURE | 19
OUTCOMES
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
0 = No difficulty at all
1 = A little bit of difficulty
2 = Some difficulty
3 = A lot of difficulty
4 = Can't do because of health
PROMIS_Q02
Question 2 of PROMIS
Does your health now limit you in taking care of your personal needs (dress, comb
hair, toilet, eat, bathe)? How much difficult do you have doing your daily physical
activities, because of your health?
N/A
All patients
Tracked ongoing except at acute admissions
Patient-reported
Single answer
0 = No difficulty at all
1 = A little bit of difficulty
2 = Some difficulty
3 = A lot of difficulty
4 = Can't do because of health
PHQ2_Q01
Question 1 of PHQ-2
Over the past 2 weeks, how often have you been bothered by any of the following
problems?
1. Little interest or pleasure in doing things
N/A
All patients
Tracked ongoing except at acute admissions
Patient-reported
Single answer
0 = Not at all satisfied
1 = Several days
2 = More than half the days
3 = Nearly every day
PHQ2_Q02
Question 2 of PHQ-2
Feeling down, depressed or hopeless
N/A
All patients
Tracked ongoing except at acute admissions
Patient-reported
Single answer
0 = Not at all satisfied
1 = Several days
2 = More than half the days
3 = Nearly every day
Burden of care
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
ARIDATE
Date of arrival
Indicate the date the patient first arrived
Date used to calculate total length of stay and post-procedure length of stay
All patients
Tracked ongoing except at acute admissions
Administrative data
DATA COLLECTION REFERENCE GUIDE
HEART FAILURE | 20
OUTCOMES
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Date by DD/MM/YYYY
DD/MM/YYYY at arrival
DISDATE
Date of discharge
Indicate the date the patient was discharged
Date used to calculate total length of stay
All patients
Tracked ongoing except at acute admissions
Administrative data
Date by DD/MM/YYYY
DD/MM/YYYY at discharge
COMPLDEVICE
Complication due to device
Did the patient’s appointment or admission have any of the following
complications which were related to a device for Heart Failure: active bleeding
requiring exploration and/or transfusion, abscess related to the device, minor
infection (localized, treated with antibiotics and surgical drainage) related to the
device, major infection (systemic, requiring device explant) related to the device,
minor malfunction (requiring follow-up appointment/reprogramming), and/or
major malfunction (requiring explant or revision)?
N/A
All patients
Tracked ongoing except at acute admissions
Clinician-reported
Single answer
0 = No
1 = Yes
2 = Unknown
COMPLHOSP
Complication of treatment due to hospitalization
Did the patient have a major nosocomial infection (requiring IV antibiotics and/or
prolonged hospital stay – 14 days or more) during this admission?
N/A
All patients
Tracked ongoing except at acute admissions
Clinician-reported
Single answer
0 = No
1 = Yes
2 = Unknown
COMPLMED
Complication due to medication
Did the patient have: a major adverse event, or major allergic reaction requiring
medical treatment, related to Heart Failure medication during this admission,
and/or as a cause of this admission?
A major allergic reaction (immunologic) requiring medical treatment and
discontinuation of the medication
All patients
Tracked ongoing except at acute admissions
Clinician-reported
Single answer
0 = No
1 = Yes
2 = Unknown
FINBURDEN
Financial resources
How hard is it for you to pay for the very basics like food, housing, medical care,
DATA COLLECTION REFERENCE GUIDE
HEART FAILURE | 21
OUTCOMES
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
and heating? Choose the statement which is most relevant
N/A
All patients
Tracked ongoing except at acute admissions
Clinician-reported
Single answer
0 = Very hard
1 = Somewhat hard
2 = Not hard at all
999 = Unknown
Mortality
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
Variable ID:
Variable:
Definition:
Supporting Definition:
Inclusion Criteria:
Timing:
Reporting Source:
Type:
Response Options:
DATA COLLECTION REFERENCE GUIDE
DEATH
Patient died, regardless of cause
Indicate if the patient has died
N/A
All patients
Tracked ongoing
Administrative data
Single answer
0 = No
1 = Yes
2 = Unknown
DEATHDATE
Date of death
Indicate the date the patient was declared dead
N/A
All patients
Tracked ongoing
Administrative data
Date by DD/MM/YYYY
DD/MM/YYYY
DEATHPLACE
Location of death
Indicate where patient died
N/A
All patients
If answered "yes” on the question "indicate if the patient has died" (DEATH)
Tracked ongoing
Administrative data
Single answer
1 = Hospital: acute or community hospitals/units but not psychiatric hospitals
2 = Own residence: the death occurred in the place of usual residence where this is
not a communal establishment
3 = Care home: private home or residential home or specialist nursing homes
4 = Hospices: many hospices are 'freestanding' but some are found within
hospitals. Also, hospices increasingly work in the community
888 = Other
HEART FAILURE | 22
ICHOM Contact Information
Website
http://www.ichom.org
Email Address
[email protected]
Business Address
14 Arrow Street, Suite #11
Cambridge, MA 02138
DATA COLLECTION REFERENCE GUIDE
HEART FAILURE | 23
Reference Guide Revisions
Reference Guide Version
1.1
DATA COLLECTION REFERENCE GUIDE
Location within Reference Guide
Content Change
Treatment Variables Table
Added REHAB variable
HEART FAILURE | 24
www.ichom.org
[email protected]
REFERENCE
GUIDE
DATA COLLECTION USER
MANUAL
HEART DISEASE
FAILURE | 25
CORONARY ARTERY