1. Screening Outcomes and Long-term Data
VICTORIA l Vetter, M.D.,MPH

2. Using Data to Determine Outcomes
Screening using ECGs is occurring. Over 430,566 children screened by PHW members in past 10 years.
Can we do it better and if so, how do we standardize and improve what is being done currently?
What can we learn from these data?
Can current screening help determine normal ECG findings?
Does screening find cardiac conditions?
If Yes, what happens to those children? If No, what happens?
Can screening identify safety signals?
Can screening prevent sudden cardiac death?
If Yes, what type of screening is best?

3. Screening Results DATA, DATA, DATA
Personal History
Family History
ECG
ECHO
Physical Exam
Other Testing 

4. Post-Screening Data Outcomes
DATA SHARING
Post-Screening Data Outcomes
ECHO
ECG
H&P
FAMILY
PCP
Foundations
Pharma
Industry
FDA
Academia

5. Testing Data: Initial Encounter
Physical Exam
Demographic Data
History
Murmur
Blood Pressure
Marfan Stigmata
Brachial vs. Femoral pulses
Height and Weight
Personal History
Chest Pain/Shortness of Breath
Syncope
Exercise Intolerance
Activity
Family History
Sudden death, syncope, seizure
Specific SCD associated condition
ECG
ECHO

6. Testing Data Outcomes ECG ECHO Normal values Modifying factors
Age
Sex
Race
Ethnicity
Modifying factors
Activity
Body habitus/BSA/BMI
Blood Pressure
Normal values
Age
Sex
Race
Ethnicity
Modifying factors
Activity
Body habitus/BSA/BMI
Blood Pressure

7. Testing Data Abnormalities
ECG
ECHO
Diagnosis: WPW
Possible Diagnosis: LQTS
Abnormal Finding: LVH
Normal
True negative
False negative (CPVT, Coronary artery anomaly)
Diagnosis: HCM, Anomalous Coronary Artery Origin
Possible Diagnosis: HCM vs. Athletic Heart
Normal
True negative
False negative (HCM, ARVD, LVNC)
Long-term Data and Outcomes

8. Testing Data Abnormalities
Long-term Data and Outcomes
Follow Up Testing: Type and Results
Follow Up Diagnoses
Validate “Definitive” Diagnosis and determine Outcomes
WPW or LQTS
Clarify Diagnosis
LVH: HCM or Athletic Heart or False positive?
Follow Those with No Diagnosis
Do well long term
Have Cardiac Event
Core Annual Data

9. Testing Data Abnormalities
Long-term Data and Outcomes
Core Longitudinal Data: Annual Questions
Is the child alive?
Is the child well or not?
Has the child died?
Did the child have any heart test in the past year?
Does the child have a new heart condition?
Was the child started on any heart medication?
Did the child have a heart procedure?
Did the child have a hospital stay in the past year?
Has the child had seizures or passed out with exercise?

10. Core Longitudinal Data
How To Obtain
How to Store and Access
Family Assisted
Automation
Social Media
Clearinghouse
Data Warehouse/Repository
Data Transmission

11. NEXT STEPS: Long-term Results and Outcomes
Determine where can data be stored and how can it be accessed.
Need Manual of Operations (MOO) on how to code the variables. Need Policies and Procedures on cleaning, storage, and access to data.
Need Process to obtain follow up/outcome data after initial screens.
Discuss different needs of academia, the FDA, Industry/PhRMA and Foundation/Grass Roots Groups.
Determine other outcomes that should be added.
What other questions does the group have?

12. Thank You!

13. Screening Process Variation Who, What, Where?
Screening Organization
Screening Location
Data Acquisition
Individuals Screened
Equipment and Personnel
Test Interpretation: Criteria and Personnel

14. Screening Process Variation What is Done?
History
Personal History
Family History
ECG
ECHO
Physical Exam
Genetics

15. STANDARDIZATION: FITTING THE PIECES TOGETHER