Belgian Neuromuscular Diseases Registry (BNMDR)

The BNMDR was established in 2008. It is financed by the RIZIV-INAMI, but its content is managed by Sciensano, together with the neuromuscular reference centers. The objectives of the registry are to conduct scientific research (epidemiological, clinical, etiologic, ...) in the field of the neuromuscular diseases (NMDs), to support and improve health services given to NMD patients, and to guide the RIZIV-INAMI in providing appropriate care for those patients. It also facilitates patient recruitment for clinical trials.

Data and Resources

Field	Value
Modified	2020-08-06
Release Date	2018-05-30
Identifier	4a34b8d6-5ee7-41ef-9278-5a5c0c39012c
License	Creative Commons Attribution
Public Access Level	Public

Protocol

Protocol
Full title of the project	Belgian Neuromuscular Diseases Registry (BNMDR)
Title of the project for lay people, in easily understood, i.e. non-technical, language	Belgian Neuromuscular Diseases Registry
Name or abbreviated title of the project where available	BNMDR
Source type	Patient registries

Sponsor(s)

Primary organization that oversees implementation of study and is responsible for data analysis.
Name of organisation	Scientific Institute of Public Health [Dienst Gezondheidszorgonderzoek]

Commissioner(s)

Organisation (1) that commissioned this project
Name of organisation (1)	National Institute for Health and Disability Insurance
Website(s) of organisation (1)	Website

Organisation (2) that commissioned this project
Name of organisation (2)	Patrick Dufrane

Source(s) of Monetary or Material Support

Organisation providing support
Name of organisation	National Institute for Health and Disability Insurance
Website(s) of organisation	Website

Governance

Governance
Is there a Steering / Accompanying committee?	Yes
Name of Steering/Accompanying Committee (1)	BNMDR steering committee
Composition of Steering/Accompanying Committee (1)	2 representatives from the RIZIV-INAMI, 2 representatives from Sciensano, 1 representative from each neuromuscular reference center, 1 representative from each patient association

General information

General information
Project description	The BNMDR was established in 2008. It is financed by the RIZIV-INAMI, but its content is managed by Sciensano, together with the neuromuscular reference centers. The objectives of the registry are to conduct scientific research (epidemiological, clinical, etiologic, ...) in the field of the neuromuscular diseases (NMDs), to support and improve health services given to NMD patients, and to guide the RIZIV-INAMI in providing appropriate care for those patients. It also facilitates patient recruitment for clinical trials.
Links	Data Collection Definition BNMDR website

Medical condition or disease under investigation
Medical condition(s) being investigated	Neuromuscular diseases

Therapeutic area
Disease	Musculoskeletal Diseases Nervous System Diseases

Objective of the project
Main objective of the project	to facilitate clinical, epidemiological and etiological research in the field of neuromuscular diseases; to support and promote the quality of health care in the NMRCs; to provide information to the public health authorities for management of the agreement and planning of health care; and to facilitate the recruitment of patients for research on new treatments. The information contained in the registry covers, for the majority of the diseases, basic data such as age, gender, geographical origin (district), diagnosis, functional status of the person, reference centre where they are being monitored. Two diseases — Duchenne muscular dystrophy and spinal muscular atrophy — are also registered at international level by a network calledTREAT-NMD. In this case, more detailed clinical data are also collected within the registry for subsequent sharing with the various international partners. The registry and its contents are overseen each year by a scientific committee composed of specialised doctors from the reference centres, a doctor from the College of Medical Directors of the INAMI, and representatives from
Additional information	No additional information available

Scope
Scope	Epidemiology Quality of care research

Legal basis

Type of legal basis
Type of legal basis	Other

Legal documents
Full reference of legal document	Revalidatieovereenkomst inzake tenlasteneming door referentiecentra voor patiënten lijdend aan neuromusculaire ziekten.
URL to legal document	https://www.riziv.fgov.be/care/nl/revalidatie/convention/desorder-locomotor/pdf/agreement02.pdf

Design of the project

Principal inclusion and exclusion criteria
Principal inclusion criteria	All patients suffering from a neuromuscular disease living in Belgium

Data transfer frequency
Data transfer frequency	Yearly

Method of data transfer
Data transfer method(s)	Web application (eg. online registration form, upload)

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	Nurses Paramedical professionals Physicians Physiotherapists
Specialty of physicians involved (encoding) in the project	Neurology Neuropsychiatry Neurosurgery
Type of paramedical professionals involved (encoding) in the project	Ergotherapists

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?	No
Is there a procedure to provide subjects the ability to correct their registered information?	No
Additional information	No additional information available

Review

Ethics Committee
Authorization by an Ethics Committee?	Yes
Full name committee	Commissie BioMedische Ethiek van University of Leuven
Date of decision	2009-08-22
Title decision	Avis unique définitif : avis favorable

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	2010-11-17
Title decision	Beraadslaging RR nr 42/2010 van 17 november 2010
Nr. Decision	RR 42/2010

Sectoral Committee Health / Social affairs (Privacy Commission)
Authorization by the sectorial committee Health / Social affairs of the Privacy Commission	Yes
Full name committee	Sectoral Committee Health / Social affairs (Privacy Commission)
Date of decision	2010-11-16
Title decision	Beraadslaging nr. 10/062 van 20 juli 2010 met betrekking tot de verwerking van gecodeerde persoonsgegevens door het Scientific Institute of Public Health van de federale overheidsdienst volksgezondheid, veiligheid van de voedselketen en leefmilieu in het kader van het Belgische register van neuromusculaire aandoeningen (BNMDR)
Nr. Decision	SCSZ 10/062

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
Name	ICD
Version	10
Name	RIZIV
Other classification system(s)	Adapted CRAMP classification Orphanet OMIM

Data quality

Data quality
First year for which data is available	2008
Procedures for checking and validating the source data	Validation levels are incorporated in the data collection process: 1. Validation rules: validation rules are the set of predefined and functional definitions that are defined by the responsible researcher of organization. Every new registration entered in the application needs to comply to these validation rules before they can be transferred. 2. Revision: a revision of the data is done by the responsible researcher after receiving the data to exclude any anomaly that was not detected by the validation rules.
Data compilation process	Not relevant
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	Very high (80-100%)
Participation rate of the health professionals	Very high (80-100%)
Extent of unit non-response	Low (5-9%)
Extent of the item non-response	There is some item non-response (5% to under 15%)
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	Comparability across the Belgian regions is restricted to some extend
Comparable or reconcilable over time	There are no restrictions concerning comparability over time
Additional information	No additional information available
Extent of problems with the misclassification of statistical units for their key variables	Medium (10-19%)
Can records belonging to same entity be matched?	Yes, no restriction in time
Additional information	Patients without a NISS are not registered.

Data storage

Data storage
Total number of unique records	35749
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)?	Yes
Additional information	No additional information available

Data access

Data access
Written Data sharing policy?	Yes

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