Socioeconomic Status and Cystic Fibrosis Clinical Outcomes study

Over the past decades, there has been a remarkable increase in the life expectancy of patients with cystic fibrosis (PWCF). It is believed that socio-economic status has, along with other factors, an impact on the disease prognosis.

The “Socioeconomic Status and Cystic Fibrosis Clinical Outcomes study” (SESCFO) is a study about the relation between the socio-economic determinants and the clinical processes and disease outcomes of patients with cystic fibrosis in Belgium in the period 2005-2015.

This study will combine existing data from different sources:

The Belgian Cystic Fibrosis Registry (BCFR), which is yearly collecting data from the Belgian reference centres for cystic fibrosis for epidemiological research.
The Belgian Cystic Fibrosis Association (BCFA), an organisation for people with cystic fibrosis, has information on non-reimbursed medication, medical services and other financial support.
The intermutualistic agency (IMA-AIM) who manages a database of the expenses of the national health insurance made by all Belgian mutualities, including the reimbursed medication, medical services and socio-economic status of a patient.
The crossroads bank of social security (KSZ-BCSS) with extensive data on the socio-economic status of all Belgian inhabitants.

Data and Resources

Socioeconomic Status and Cystic Fibrosis Clinical Outcomes studyjson Download

Field	Value
Publisher	Sciensano
Modified	2020-12-29
Release Date	2018-05-09
Identifier	aaf7e845-f257-46c6-b4a6-599cfab37057
License	Creative Commons Attribution
Public Access Level	Public

Protocol

Protocol
Full title of the project	Socioeconomic Status and Cystic Fibrosis Clinical Outcomes study
Name or abbreviated title of the project where available	SESCFO
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 that commissioned this project
Name of organisation	Belgian Cystic Fibrosis Association
Website(s) of organisation	http://www.muco.be/

Governance

Governance
Is there a Steering / Accompanying committee?	No information available

General information

General information
Project description	Over the past decades, there has been a remarkable increase in the life expectancy of patients with cystic fibrosis (PWCF). It is believed that socio-economic status has, along with other factors, an impact on the disease prognosis. The “Socioeconomic Status and Cystic Fibrosis Clinical Outcomes study” (SESCFO) is a study about the relation between the socio-economic determinants and the clinical processes and disease outcomes of patients with cystic fibrosis in Belgium in the period 2005-2015. This study will combine existing data from different sources: The Belgian Cystic Fibrosis Registry (BCFR), which is yearly collecting data from the Belgian reference centres for cystic fibrosis for epidemiological research. The Belgian Cystic Fibrosis Association (BCFA), an organisation for people with cystic fibrosis, has information on non-reimbursed medication, medical services and other financial support. The intermutualistic agency (IMA-AIM) who manages a database of the expenses of the national health insurance made by all Belgian mutualities, including the reimbursed medication, medical services and socio-economic status of a patient. The crossroads bank of social security (KSZ-BCSS) with extensive data on the socio-economic status of all Belgian inhabitants.

Therapeutic area
Disease	Nutritional and Metabolic Diseases

Objective of the project
Main objective of the project	The main goals of the SESCFO-study are to: determine the socio-economic status of patients with cystic fibrosis (PWCF) investigate the relation beween clinical outcomes and socio-economic status of PWCF determine the treatment burden and its evolution, as estimated by the cost of care identify factors linked to these costs, including the costs of non-reimbursed care.
Public health relevance of project	The results of this study can lead to an improved epidemiological knowledge of cystic fibrosis and a better insight on how to improve the quality of life of PWCF and their integration in the community.
Scientific relevance of the project	The study design and choice of the research questions about the care of cystic fibrosis and the socio-economic status (SES) of PWCF are based on scientific literature, which has indicated that SES has an effect on the clinical outcome and that there is a need for further identification of the groups at risk. This study is part of a PhD in medical sciences at the VUB in collaboration with WIV-ISP.
Additional information	No additional information available

Legal basis

Type of legal basis
Type of legal basis	Unknown

Design of the project

Principal inclusion and exclusion criteria
Principal inclusion criteria	Patients with cystic fibrosis: all patients diagnosed with CF in either the BCFR or the BCFA database. Patients with a cystic fibrosis care agreement: all patients present in the IMA database who have signed an agreement with a CF reference centre in Belgium and suffering from cystic fibrosis with nomenclature codes 75913,775924,775935, of 775946. Control group: for every CF patient, a selection of 2 non-CF patients from the crossroads bank for social security (KSZ-BCSS), with the same age, gender and province of residence as the CF patient.

Data transfer frequency
Data transfer frequency	Other frequency
Other frequency: specification	One time data collection

Method of data transfer
Data transfer method(s)	eHealthbox of eHealth Platform

Sites involved in the project

Type of site(s)
Care Provider	Unknown

Health professionals involved (encoding) in the project

Health professionals involved (encoding) in the project
Care Giver	Unknown
Specialty of physicians involved (encoding) in the project	Unknown
Type of paramedical professionals involved (encoding) in the project	Unknown

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	No additional information available

Review

Ethics Committee
Authorization by an Ethics Committee?	No information available

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

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

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

Data dictionary

Classifications and Terminology
Name	Unknown

Data quality

Data quality
First year for which data is available	No information available
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	No information available
Punctuality for the most recent completed data collection: the data collection was completed	No information available
Participation rate of the health institutions	No information available
Participation rate of the health professionals	No information available
Extent of unit non-response	No information available
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	Comparability across the Belgian areas is unknown
Comparable or reconcilable over time	Comparability over time is unknown
Additional information	No additional information available
Extent of problems with the misclassification of statistical units for their key variables	No information available
Can records belonging to same entity be matched?	No information available
Additional information	No additional information available

Data storage

Data storage
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?	No information available

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