Surveillance of Clostridium difficile Infections

Clostridium difficile infections (CDI), in particular due to hypervirulent strains, are a major cause of healthcare-associated infections. Surveillance of CDI according to the surveillance protocol is compulsory for acute care hospitals since 2007. For at least 6 months per year (first or last 6 months of the year), hospitals have to register all cases of CDI in the institution. This is a patient-based surveillance (as opposed to aggregated data): the unit of the database is the infection. These data are used to compute incidence rates at hospital and national level.

Data and Resources

Field	Value
Modified	2020-08-03
Release Date	2018-06-27
Identifier	1af906ca-b277-4348-bc94-81a8ceaee754
License	Creative Commons Attribution
Public Access Level	Public

Protocol

Protocol
Full title of the project	Surveillance of Clostridium difficile Infections
Title of the project for lay people, in easily understood, i.e. non-technical, language	Surveillance of Clostridium difficile infections
Name or abbreviated title of the project where available	NSIH CDIF
Source type	Patient registries

Sponsor(s)

Primary organization that oversees implementation of study and is responsible for data analysis.
Name of organisation	Sciensano [Dienst Zorginfecties & Antimicrobiële Resistentie]

Commissioner(s)

Organisation (1) that commissioned this project
Name of organisation (1)	Federal Public Service Health, Food Chain Safety and Environment - cell quality and patient safety
Website(s) of organisation (1)	Website

Organisation (2) that commissioned this project
Name of organisation (2)	Michiel Costers

Source(s) of Monetary or Material Support

Organisation (1) providing support
Name of organisation (1)	Federal Public Service Health, Food Chain Safety and Environment - cell quality and patient safety
Website(s) of organisation (1)	Website

Organisation (2) providing support
Name of organisation (2)	National Institute for Health and Disability Insurance
Website(s) of organisation (2)	Website

Additional information	There is no specific budget for this database, it is part of the larger funding for the unit National Surveillance of Infections in Hospitals.In practice, hospitals receive a certain amount of money from the SPF/FOD, and they transfer this money to our unit when participating to surveillance. National Institute for Health and Disability Insurance: funding for the data collection by healthdata.be.

Governance

Governance
Is there a Steering / Accompanying committee?	No

General information

General information
Project description	Clostridium difficile infections (CDI), in particular due to hypervirulent strains, are a major cause of healthcare-associated infections. Surveillance of CDI according to the surveillance protocol is compulsory for acute care hospitals since 2007. For at least 6 months per year (first or last 6 months of the year), hospitals have to register all cases of CDI in the institution. This is a patient-based surveillance (as opposed to aggregated data): the unit of the database is the infection. These data are used to compute incidence rates at hospital and national level.

Therapeutic area
Disease	Bacterial Infections and Mycoses Infectious Diseases

Objective of the project
Main objective of the project	Op het niveau van het ziekenhuis: De incidentie meten en volgen in de tijd (bijv. voor het opvolgen van het effect van geïmplementeerde richtllijnen) Microbiologisch luik: identificeren van de genotypische karakteristieken van de geïsoleerde C. difficile stammen door de samenwerking met het nationaal referentielaboratorium (binair toxine, deletie van tcdC, ribotyping) Op nationaal niveau: Opvolgen van de nationale incidentie van CDIs Opvolgen van de klinische ernst van CDIs Microbiologisch luik: identificeren van C.difficile stammen in Belgische ziekenhuizen en beschrijven van de epidemiologie op landelijk niveau
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	19 juni 2007. - Koninklijk besluit tot wijziging van het koninklijk besluit van 25 april 2002 betreffende de vaststelling en de vereffening van het budget van financiële middelen van de ziekenhuizen (Publicatie: 28 juni 2007)
URL to legal document	http://www.ejustice.just.fgov.be/mopdf/2007/06/28_2.pdf#Page27

Design of the project

Principal inclusion and exclusion criteria
Principal inclusion criteria	Alle CDI-patiënten opgenomen in het ziekenhuis gedurende elke periode van surveillance (6 maanden). Patiënten in dagopname of ambulante patiënten (bv. voor dialyse) waarbij CDI wordt vastgesteld, mogen ook in de surveillance worden opgenomen voor wat de infectiegegevens betreft. Deze patiënten mogen echter niet in de noemergegevens opgenomen worden (zie paragraaf 5). Evenmin zullen ze meegenomen worden in de analyses voor de bepaling van de CDI-incidenties.

Data transfer frequency
Data transfer frequency	Ad hoc (event based)
Other frequency: specification	Minimale participatieperiode voor deze surveillance bedraagt 6 maanden, maar aan de ziekenhuizen wordt het sterk aangeraden om gedurende het ganse jaar deel te nemen: De extra werklast voor deelname gedurende het ganse jaar is beperkt : 75% van de ziekenhuizen hebben minder dan 15 gevallen per semester. In het kader van een lokale verbetering, is het noodzakelijk om gedurende het ganse jaar gegevens te verzamelen. De incidentie van C. difficile is seizoensgebonden. Deelname gedurende een gans jaar laat toe om een jaarlijkse incidentie te berekenen. De surveillance gebeurt per semester (van 1 januari tot 30 juni en/of van 1 juli tot 31 december) en data dient te worden doorgegeven ten laatste 3 maanden na het einde van het semester.

Method of data transfer
Data transfer method(s)	eHealthbox of eHealth Platform 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 Physicians
Specialty of physicians involved (encoding) in the project	Microbiologists Other medical specialisation

Informed consent

Informed consent
Are subjects informed?	No
How are subjects informed?	Not applicable
Do subjects have to give their consent?	No
How do subjects give their consent?	Not applicable
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?	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	Yes
Full name committee	Sectoraal Comité van de Sociale Zekerheid en van de Gezondheid
Date of decision	2016-12-20
Title decision	BERAADSLAGING NR. 16/111 VAN 20 DECEMBER 2016 BETREFFENDE DE MEDEDELING VAN GECODEERDE PERSOONSGEGEVENS DIE DE GEZONDHEID BETREFFEN VIA HET HEALTHDATA-PLATFORM IN HET KADER VAN DE OPVOLGING VAN ZORGINFECTIES EN ANTIMICROBIELE RESISTENTIE
Nr. Decision	SCSZG/16/245

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	2007
Procedures for checking and validating the source data	Validation levels are incorporated in the data collection process: 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. 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	Data cleaning, descriptive analyses
Punctuality for the most recent completed data collection: the data collection was completed	On time
Participation rate of the health institutions	Very high (80-100%)
Participation rate of the health professionals	No information available
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	10000
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
Additional information	No additional information available

Data access

Data access
Written Data sharing policy?	No

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