Belgian sickle cell anemia registry

. A database was set up in Belgium to collect clinical and laboratory data including parental phenotype, diagnostic technique (neonatal screening or not), major clinical events (episodes of dactylitis, acute chest syndrome, severe anemia, infection, etc), number and duration of required hospitalizations, and treatment used.
The objectives:
To learn about characteristics of this population
To create the connection between practionners
(general, emergency and specialist practionners)
Unambigous information
Personalized contact
Research projects
State-of-the art, Guidelines
Information diffusion ( associations, authority)
Tool for educational projects
To serve of structure (framework) for other chronical pathologies

Data and Resources

Field	Value
Modified	2020-08-01
Release Date	2018-08-14
Identifier	1cb3cc86-7655-471f-ac55-c47ba778ff97
License	Creative Commons Attribution
Public Access Level	Public

Protocol

Protocol
Full title of the project	Belgian sickle cell anemia registry
Name or abbreviated title of the project where available	No abbreviation available
Source type	Patient registries

Sponsor(s)

Primary organization that oversees implementation of study and is responsible for data analysis.
Name of organisation	Erasmus Holspital Université Libre de Bruxelles [Erasmusziekenhuis ULB (Université Libre de Bruxelles)]

Commissioner(s)

Organisation that commissioned this project
Name of organisation	Béatrice Gulbis

Source(s) of Monetary or Material Support

Additional information	The European Commission was a partial sponsor via our european group ENERCA www.enerca.orgNovartis Belgium was also a partial sponsor by giving a grant to a paediatricain who entered the data.

Governance

Governance
Is there a Steering / Accompanying committee?	Yes
Name of Steering/Accompanying Committee (1)	Belgian Hematological Society - Red Blood Cells Committee
Composition of Steering/Accompanying Committee (1)	Chair : Gulbis Béatrice - Members see www.bhs.be

General information

General information
Project description	. A database was set up in Belgium to collect clinical and laboratory data including parental phenotype, diagnostic technique (neonatal screening or not), major clinical events (episodes of dactylitis, acute chest syndrome, severe anemia, infection, etc), number and duration of required hospitalizations, and treatment used. The objectives: To learn about characteristics of this population To create the connection between practionners (general, emergency and specialist practionners) Unambigous information Personalized contact Research projects State-of-the art, Guidelines Information diffusion ( associations, authority) Tool for educational projects To serve of structure (framework) for other chronical pathologies

Therapeutic area
Disease	Blood and lymphatic diseases

Objective of the project
Additional information	No additional information available

Scope
Scope	Epidemiology Quality of care research

Design of the project

Data transfer frequency
Data transfer frequency	Yearly

Method of data transfer
Data transfer method(s)	Other method
Other method of data transfer: specification	if not entered directly on the website; encrypted SSL

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 Nurses
Specialty of physicians involved (encoding) in the project	Dermato-venereology Other medical specialisation

Informed consent

Informed consent
Are subjects informed?	Yes
Do subjects have to give their consent?	Yes
How do subjects give their consent?	Yes
Is there a procedure to provide subjects the ability to consult their registered information?	Yes
Is there a procedure to provide subjects the ability to correct their registered information?	Yes
Describe the procedures to provide the subjects the ability to consult and correct the information	The subjects are physicians. They possess an access code for the data base. They can give new information on their patients to the manager of the data base.
Describe the procedures to provide the subjects the ability to consult and correct the information	The subjects are physicians. They possess an access code for the data base. They can give new information on their patients to the manager of the data base.
Additional information	No additional information available

Review

Ethics Committee
Authorization by an Ethics Committee?	Yes
Full name committee (1)	C.H.U. Saint-Pierre O.M. 007
Date of decision (1)	2007-07-05
Title decision (1)	EudraCT:CCB B07620073095
Full name committee (2)	HOPITAL ERASME O.M. 021
Date of decision (2)	2009-02-10
Title decision (2)	EudraCT:CCB B07620073095

Sectoral Committee National Registry (Privacy Commission)
Authorization by the sectorial committee Health / Social affairs of the Privacy Commission	Yes
Full name committee	Sectoral Committee National Project (Privacy Commission)
Date of decision	2008-07-14
Title decision	Avis favorable
Nr. Decision	HM 000349396 - VT005005231 (origineel ingevuld, na vragen naar het RR nummer kwam dit, even handig om terug te vinden dus... AK/07-11-64/3473)

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 quality

Data quality
First year for which data is available	2008
Procedures for checking and validating the source data	Not an open data base - items = allowed characters check, limit check
Data compilation process	Internet server: Apache/PHP Database: MySQL, Oracle Development: PL/SQL, PHP, JS, CMS- XOOPS, FLASH, XML
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	Medium (40-59%)
Extent of unit non-response	No information available
Extent of the item non-response	There is little item non-response (<5%)
Necessity of editing the raw data	There is a lot of item non-response (15% to under 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	Comparability over time is restricted to some extent
Additional information	No additional information available
Extent of problems with the misclassification of statistical units for their key variables	Not applicable
Can records belonging to same entity be matched?	Yes, no restriction in time
Additional information	No additional information available

Data storage

Data storage
Total number of unique records	503
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?	No

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