Data Entry System

System Changes

• All forms in the data entry system can be translated. A user will need translation permissions to be able to edit and submit any translation. Any user is able to view the translated forms in approved languages
• Monthly Surgery Count Verification Table: When you sign in to the database, select the reports tab and a count of surgeries and deaths entered at your center is displayed. Please confirm that this information is correct on a monthly basis
• Date and range validations are added
• Tier 2 Discharge due date is added to the dashboard
• Height and weight question options are reordered on the data entry forms
• New navigation bar

Follow Up form (Changed name from One Year Follow Up)

• Modified question 1 to say, ‘Do you have any follow up information since the most recent form (discharge/90 days or follow up) was completed?’ Answer option: ‘Yes or No’
• Added Question 1a ‘How was the follow up information obtained?’ Answer option: ‘Phone, clinic, hospital, relative, or other, specify’
• Added Question 1b ‘Is the patient alive?’ Answer option: ‘Yes, No, or Unknown’
• Added Question 1c if patient is alive or unknown ‘Has the ongoing care of the patient been transferred to another facility?’ Answer option: ‘Yes or No’ If ‘Yes’ selected add date: Month/year
• Question 5 ‘NYHA Functional Class’ has been removed

Demographics form

• Moved questions 5 and 5a from the Tier 1 Surgery form to the Demographics form
• Question 5a now asks for the number of operations per surgery type

Institutional Practice Details form

• Added Question 3a ‘How is a congenital heart surgeon certified in your country?’
• Geographic Region served are reported on the IPD form in question 5:
• Modified answer option for Question 5, ‘Local: one city or metro area, Regional: geographically larger than a metro area, National: one country/multiple countries, International: multiple countries’
• Estimation population served are reported on the IPD form in question 6:
• Added answer option of ‘Less than 10 million’
• Added answer option of ’10-30 million’
• Added answer option ’31-50 million
• Added answer option of ‘Greater than 51 million’
• Added answer option of ‘Unknown’
• Added Question 12a ‘Does your hospital provide extracorporeal cardiopulmonary resuscitation (ECPR)?’ Answer option, ‘Yes or No’
• Added Question 15 ‘Does your hospital have an Electronic Medical Records system (EMR)?’ Answer option, ‘Yes or No’ If ‘Yes’ is selected enter software vendor
• Added Question 16 ‘Does your hospital participate in a National Congenital Heart Surgery Database?’ Answer option, ‘Yes or No’ If ‘Yes’ is selected enter name of database
• Added Question 17 ‘Does your hospital have a routine preoperative planning conference?’ Answer option, ‘Yes or No’
• Added Question 18 ‘Does your hospital have intraoperative Trans esophageal ECHO?’ Answer option, ‘Yes or No’
• Added Question 19 ‘Does your hospital have intraoperative Epicardial ECHO?’ Answer option, ‘Yes or No’
• Added Question 20 ‘Who performs the Pre-operative Trans Thoracic ECHO?’ Answer options ‘Cardiologist, Cardiac Surgeon, or Trained ECHO Technologist’
• Added Question 21 ‘Usual Patient follow up post discharge’ Answer option, ‘Cardiologist, Surgeon, Referring Physician, Other, Specify’

Non-Cardiac Reoperations (Manual)

• Non-cardiac reoperations are reported on the Follow Up and Post-Operative Events form in question 2b
• Added answer option of ‘Gastrostomy tube placement’
• Added answer option of ‘Pericardial drainage tube/catheter’
• Added answer option of ‘Pleural drainage tube/catheter’
• Added answer option of ‘Mediastinal Drainage/Exploration for blood or fluid’
• Added answer option of ‘Mediastinal Drainage/Exploration for infection’
• Removed answer option of ‘Pulmonary Embolectomy’
• Removed answer option of ‘Requirement for Shunt Revision’
• Modified answer option of ‘Wound Debridement/exploration’

Post-Operative Mechanical Circulatory Support (Manual)

• Post-Operative Mechanical Circulatory Support are reported on the Follow Up and Post-Operative Events form in question 2bi
• Added answer option of ‘Durable VAD (Durable Ventricular Assist Device)’
• Added answer option of ‘ECMO (Extracorporeal Membrane Oxygenation)’
• Added answer option of ‘IABP (Intra-Aortic Balloon Pump)’
• Added answer option of ‘Temporary VAD (Cardiopulmonary Support)’

Catheter-based Interventions (Manual)

• Catheter-based interventions are reported on the Follow Up and Post-Operative Events form in question 3b
• Modified list:
  • Aortic Arch: Balloon /Stent Placement
  • Aortic Valve: Balloon Valvuloplasty
  • Arrhythmia ablation
  • Arterial-Pulmonary (AP) collaterals: Occluding Device, placement
  • Atrial Septal Defect: Occluding Device, placement
  • Descending Aorta / Isthmus: Balloon /Stent Placement
  • Drainage of Seroma
  • Mitral Valve: Balloon Valvuloplasty
  • Patent Ductus Arteriosus: Balloon/Stent placement
  • Patent Ductus Arteriosus: Occluding Device, placement
  • Pulmonary Veins: Balloon/Stent placement
  • Pulmonary Valve: Balloon Valvuloplasty
  • RVOT: Balloon/Stent placement
  • Shunt Closure
  • Shunt Thrombolysis
  • Systemic Veins: Balloon/Stent placement
  • Systemic to Pulmonary Stunt: Balloon/Stent placement
  • Veno-venous collaterals: Occluding Device, placement

Demographics Form

• Added answer option to Race list, ‘Caribbean’
• Added answer option to Race list, ‘Mixed race’
• Modified answer option on Race list, ‘Pacific Islander (Native Hawaiian)’ to remove (Native Hawaiian)

Diagnosis (Appendix B)

Diagnoses are reported on the Tier 1 and Tier 2 Surgery Forms in question 3

• Added answer option of ‘Cardiac trauma’

Pre-operative Risk Factors (Appendix F)

Pre-operative risk factors are reported on the Tier 1 Surgery Form in question 6

• Added answer option of ‘Greater than 2 hospital admission for non-cardiac infections in the last 3 months’.
• Added answer option of ‘Malnutrition: as noted by the clinician in the History & Physical’

Site Dashboard

• The ‘Pending and In Progress’ Grid will now indicate forms that are past due by highlighting them in red. Forms are due within 30 days of the event that is being reported.

Reporting

• Added ability to download, view, and sign off on reports. Centers will begin to receive monthly Data Quality Reports. Centers will review these reports, make any corrections as necessary in the database, and then sign off on the reports in the data entry system. Additional details and the first Data Quality Reports will be coming soon.

Tier 1 Surgery Form

• Added answer option of ‘Pericardial Disease (Non Specific)’ under question 3, ‘Primary Cardiac Diagnosis’ (added April 24, 2018)
• Added answer option of ‘Pericardial Disease (Non Specific)’ under question 4a, ‘Additional Cardiac Diagnosis’ (added April 24, 2018)

Tier 2 Surgery Form

• Added answer option of ‘Pericardial Disease (Non Specific)’ under question 3, ‘Primary Cardiac Diagnosis’ (added April 24, 2018)
• Added answer option of ‘Pericardial Disease (Non Specific)’ under question 4a, ‘Additional Cardiac Diagnosis’ (added April 24, 2018)

Post Op Events Form

• Added answer option of ‘Pneumonia’ to question 1a, complications. (added April 24, 2018)

Add Surgery Form

• Previously this form collected the date of birth in the form of month/year. This field will now be collected as day/month/year.

Tier 2 Surgery Form (New Form)

• A new form has been added to collect patient status at discharge for Tier 2 surgeries. This form will automatically generate for Tier 2 surgery patients and cannot manually be entered.

Death Form

• Validations have been added to the death date to so that if intra-op mortality is reported as ‘yes’, the date of death on the death form will be required to be within one day of the Tier 1 Surgery date.
• Additional validations within forms have been added so that if a death is reported on Tier 1 patients within another form a death form will automatically generate.

Tier 1 Surgery form

• A new question has been added (question 16) that asks, “Was sternum left open at the end of operation”.

Post Operative Events Form:

• Question 2 (Non-Cardiac Operations within this admission) was previously a radio button where only one option could be selected. This question is now a ‘repeating section’ so the user can enter more than one operation and date.
• Question 3 (Catheter-based Interventions within this admission) was previously a radio button where only one option could be selected. This question is now a ‘repeating section’ so the user can enter more than one intervention and date.

One Year Follow-up Form

• Question 2 (Readmission for a Non-Cardiac Operations since completion of the post operative events form)was previously a radio button where only one option could be selected. This question is now a ‘repeating section’ so the user can enter more than one operation and date.
• Question 3 (Catheter based Interventions since completion of the post operative events form) was previously a radio button where only one option could be selected. This question is now a ‘repeating section’ so the user can enter the more than one intervention and date.

Complications (Appendix H)

Complications are reported on the post operative events form in question 1.

• Added answer option of Spinal cord injury, Neurological deficit persisting at discharge
• Added answer option of Wound dehiscence-Median Sternotomy

Tier 1 Surgery Form

Question 3 (Primary Cardiac Diagnosis)

• If Hypoplastic Left Heart Syndrome (HLHS) is selected, two additional questions will drop down. New questions are:
  • Aortic Arch Coarctation (yes/no/unknown)?
  • Aortic Arch Hypoplasia (yes/no/unknown)?

Question 4a (Additional Cardiac Diagnoses)

• If Hypoplastic Left Heart Syndrome (HLHS) is selected, two additional questions will drop down. New questions are:
  • i. Aortic Arch Coarctation (yes/no/unknown)?
  • ii. Aortic Arch Hypoplasia (yes/no/unknown)?

Tier 2 Surgery Form

Question 1 (Primary Cardiac Procedure)

• “Other, specify” option added under the Miscellaneous Procedures category.

Question 2a (Additional Cardiac Procedures During the same OR Visit)

• “Other, specify” option added under the Miscellaneous Procedures category.

Question 3 (Primary Cardiac Diagnosis)

• If Hypoplastic Left Heart Syndrome (HLHS) is selected, two additional questions will drop down. New questions are:
  • i. Aortic Arch Coarctation (yes/no/unknown)?
  • i. Aortic Arch Hypoplasia (yes/no/unknown)?

Question 4a (Additional Cardiac Diagnoses)

• If Hypoplastic Left Heart Syndrome (HLHS) is selected, two additional questions will drop down. New questions are:
  • i. Aortic Arch Coarctation (yes/no/unknown)?
  • ii. Aortic Arch Hypoplasia (yes/no/unknown)?