National Congenital Heart Disease Audit

Study Overview
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Brief Summary
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The National Institute of Cardiovascular Outcomes Research (NICOR) collects data and produces analysis to enable hospitals and healthcare improvement bodies to monitor and improve the quality of care and outcomes of cardiovascular patients. The Congenital Heart Disease audit collects data on all cardiac surgery and therapeutic cardiac catheterisations procedures used to treat patients with congenital and acquired heart disease. For acquired heart disease, the audit covers all arrhythmias & cardiomyopathies in patients less than 16 years old only. For congenital heart disease, the audit collects data on both children and adult patients. The audit covers all specialist centers in the UK and Republic of Ireland. The project aims to improve the quality of care for children and adults with congenital heart disease by providing national comparative analysis of procedure specific activity and outcomes of cardiac surgery and therapeutic cardiac catheterisation procedures. The audit also provides quality indicators for the antenatal detection of major congenital heart disease. The current dataset is available from here: http://www.ucl.ac.uk/nicor/audits/congenital/datasets

Detailed Description
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The Congenital Heart Disease audit collects data on all cardiac surgery and therapeutic cardiac catheterisations procedures used to treat patients with congenital and acquired heart disease Data collection: Hospitals use Patient Administration Systems and manual data entry by cardiac database managers to submit data to NICOR. Data are either assimilated locally using third party commercial software and imported as a .csv file, or entered directly onto the NICOR database. Data quality: NICOR provide tools that communicate possible errors to centres submitting data. A data submitting schedule has been agreed with the centres, data is submitted and a validation report is returned each quarter. Centres are responsible for updating errors in the records. An import log highlights missing and invalid data as well as records that failed to import due to data quality or compatibility issues. In addition, data is validated by on site visits with a NICOR representative. Data linkage: Data is annually linked with Office fot National Statistics (ONS) life status and Hospital Episodes Statistics (HES) admission data to verify case ascertainment and to track long term outcome measures. Information governance: NICOR has Section 251 approval and data protection registration. An organisation-wide standard operating procedure is in place for Information Security Incident Management. University College London has a robust information governance framework, to which NICOR adheres.

Official Title
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National Congenital Heart Disease Audit

Conditions
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Congenital Heart Disease (CHD)

Intervention / Treatment
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* Procedure: Cardiac Surgery
* Procedure: Therapeutic cardiac catheterisations procedures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient, judged by multidisciplinary team meeting as unsuitable for the procedure Exclusion Criteria: Patient, judged by multidisciplinary team meeting, as unsuitable for the procedure
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Congenital<br>All patients with congential and acquired heart disease treated by cardiac surgery and therapeutic cardiac catheterisations procedures . For acquired heart disease, the audit covers all arrhythmias & cardiomyopathies in patients less than 16 years old only. For congenital heart disease, the audit collects data on both children and adult patients. | Procedure: Cardiac Surgery<br>* All patients with congential and acquired heart disease treated by cardiac surgery procedures.<br>* Other names: PDA ligation (surgical);Procedure: Therapeutic cardiac catheterisations procedures<br>* All patients with congential and acquired heart disease treated by therapeutic cardiac catheterisations procedures .<br>* Other names: Implantable Cardioverter Defibrillator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day survival rates | The analysis shows the national survival rates at 30 days for each procedure and the national survival rates for individual procedures by age. | 30 day survival from operation date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 year survival rates | Analysis include 1-year outcome but a death would not appear in the table until a full year has passed for the whole cohort of patients within that year. For example, the audit collection period is based on financial year of April 1st to March 31st. A patient that died in April would be reported within the same period as one that died 11 months later in March. | 1 year survival rates after the date of the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital heart disease, European Paediatric Cardiac Code Short List, Specific Procedure Definitions, OPCS, paediatric, pediatric