Registry Belgian Association for Cardio-Thoracic Surgery + Transcatheter Aortic Valve Implantation

Registry of cardiac surgery in Belgium, to study the activity, risk factors and outcome.Mission is to improve the quality of care

Data and Resources

Epidemiology

General Hospitals

Physicians

Quality of care research

Field	Value
Modified	2020-07-25
Release Date	2018-05-08
Identifier	74db0f80-321b-4c64-91ee-8c2a40db5aaa
License	Creative Commons Attribution
Public Access Level	Public

Protocol

Protocol
Full title of the project	Registry Belgian Association for Cardio-Thoracic Surgery + Transcatheter Aortic Valve Implantation
Name or abbreviated title of the project where available	BACTS TAVI
Source type	Patient registries

Sponsor(s)

Primary organization that oversees implementation of study and is responsible for data analysis.
Name of organisation	Belgian Association for Cardio-Thoracic Surgery [Belgian Association for Cardio-Thoracic Surgery DBC]

Commissioner(s)

Organisation (1) that commissioned this project
Name of organisation (1)	Belgian Association for Cardio-Thoracic Surgery

Organisation (2) that commissioned this project
Name of organisation (2)	College of cardiac pathology

Governance

Governance
Is there a Steering / Accompanying committee?	No

General information

General information
Project description	Registry of cardiac surgery in Belgium, to study the activity, risk factors and outcome.Mission is to improve the quality of care

Therapeutic area
Disease	Cardiovascular Diseases

Objective of the project
Additional information	No additional information available

Scope
Scope	Epidemiology Quality of care research

Legal basis

Type of legal basis
Type of legal basis	Royal Decree

Legal documents
Full reference of legal document	15 juli 2004. - Koninklijk besluit houdende vaststelling van de normen waaraan de zorgprogramma’s ″cardiale pathologie″ moeten voldoen om erkend te worden. (Publicatie: 13 september 2004)
URL to legal document	http://www.ejustice.just.fgov.be/mopdf/2004/09/13_1.pdf#Page33

Design of the project

Data transfer frequency
Data transfer frequency	Yearly

Method of data transfer
Data transfer method(s)	Secured file transfer protocol (SFTP)

Sites involved in the project

Type of site(s)
Care Provider	General hospitals

Health professionals involved (encoding) in the project

Health professionals involved (encoding) in the project
Care Giver	Physicians
Specialty of physicians involved (encoding) in the project	Surgery

Informed consent

Informed consent
Are subjects informed?	No information available
How are subjects informed?	No information available
Do subjects have to give their consent?	No information available
How do subjects give their consent?	No information available
Is there a procedure to provide subjects the ability to consult their registered information?	No information available
Is there a procedure to provide subjects the ability to correct their registered information?	No information available
Additional information	Each cardiac surgery center has a registry. The data or exported to the BACTS registry. BACTS-DBC merges and analyses the data. And a report is made. The centers have to ask informed consent to the patients. How this is organized in the centers is not known by BACTS-DBC. All data are treated anonymous: patient, surgeon, centers are blinded.

Review

Ethics Committee
Authorization by an Ethics Committee?	No

Sectoral Committee National Registry (Privacy Commission)
Authorization by the sectorial committee Health / Social affairs of the Privacy Commission	No

Sectoral Committee Health / Social affairs (Privacy Commission)
Authorization by the sectorial committee Health / Social affairs of the Privacy Commission	No

Sectoral Committee Crossroads Bank of Enterprises (Privacy Commission)
Authorization by the sectorial committee Crossroads Bank of Enterprises of the Privacy Commission (Y/N)	No

Data dictionary

Classifications and Terminology
Additional information	The BACTS registry is based on the EACTS dataset on cardiac surgery

Data quality

Data quality
First year for which data is available	2003
Procedures for checking and validating the source data	the BACTS register was expanded in 2012, following the EACTS standards, data check is under construction, some fields cannot be blanc
Data compilation process	No information available
Punctuality for the most recent completed data collection: the data collection was completed	Less then 6 months (but more than 1 month) after the communicated deadline
Participation rate of the health institutions	No information available
Participation rate of the health professionals	No information available
Extent of unit non-response	Very high (30% - )
Extent of the item non-response	The rate of item non-response is not known or unacceptably high (>50%)
Extend to which the collected data are comparable across the Belgian regions	There are no restrictions concerning the comparability across the Belgian regions
Comparable or reconcilable over time	There are no restrictions concerning comparability over time
Additional information	We have expanded our registry in 2012. Not all centers have adapted their registration, in order to be able to register the full dataset. This will take some time. From 2003 till 2011 we have a complete registration of the cardiac surgery activity
Extent of problems with the misclassification of statistical units for their key variables	No information available
Can records belonging to same entity be matched?	Yes, no restriction in time
Additional information	Matching only possible when the same patient number is used (reoperated in the same hospital)

Data storage

Data storage
Total number of unique records	12000
The organisation in charge of storage of the collected data, is certified as being compliant with the international standards on information security management system (eg. ISO27001)?	No information available
Additional information	No additional information available

Data access

Data access
Written Data sharing policy?	Yes

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Registry Belgian Association for Cardio-Thoracic Surgery + Transcatheter Aortic Valve Implantation

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Registry Belgian Association for Cardio-Thoracic Surgery + Transcatheter Aortic Valve Implantation

Data and Resources