Clinical trial NCT02303535: National Congenital Heart Disease Audit
Official title: National Congenital Heart Disease Audit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Disease (CHD)
Keywords: Congenital heart disease
European Paediatric Cardiac Code Short List
Specific Procedure Definitions
OPCS
paediatric
pediatric
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Society for Cardiothoracic Surgery in Great Britain & Ireland
name: British Congenital Cardiac Association
First posted: 2014-12-01
Enrollment: 120000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All potential patients are assessed through a systematic process of clinical evaluation, diagnostic assessment. Patient selection is effected in each individual unit through a multidisciplinary team process. These teams consist not only of cardiac surgeons and interventional cardiologists but also of many other medical specialties and allied professionals. The decision as to the access route to be used is determined by the multidisciplinary team.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 30 day survival rates
timeFrame: 30 day survival from operation date
Secondary outcomes:
measure: 1 year survival rates
timeFrame: 1 year survival rates after the date of the procedure
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
city: Liverpool
country: United Kingdom
facility: Alder Hey Hospital
state: Merseyside
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital Belfast
state: Northern Ireland
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
state: Oxfordshire
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
state: Tyne and Wear
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
state: West Yorkshire
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital (Edgbaston)
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: London
country: United Kingdom
facility: The Harley Street Clinic
city: London
country: United Kingdom
facility: The Heart Hospital
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Rodney Franklin, MD
role: STUDY_CHAIR
References:
citation: Pagel C, Utley M, Crowe S, Witter T, Anderson D, Samson R, McLean A, Banks V, Tsang V, Brown K. Real time monitoring of risk-adjusted paediatric cardiac surgery outcomes using variable life-adjusted display: implementation in three UK centres. Heart. 2013 Oct;99(19):1445-50. doi: 10.1136/heartjnl-2013-303671. Epub 2013 Apr 5.