Clinical trial NCT03254472: Big Data Analysis of the Use of bIomarkers Concentration
Official title: Defining Use and Misuse of BIoMarkers Dosage and Trends in Observed Concentration Over Time: a BIg Data Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biological Markers
Inappropriate Prescribing
Keywords: Biological markers
Professional practice
Big data analysis
Measured concentrations
Cardiac markers
Troponin
NTproBNP
Creatinin
INR
Hemogram
Lipid profile
Lead sponsor: Hospital Avicenne
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
name: ProBayes
name: Biorance Laboratoires Réunis
First posted: 2017-08-18
Enrollment: 585745
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort that included all analyses performed in a large subset of laboratories located in the French Brittany from February 2010 the 17th to August 2015 the 30th.

The extract data corresponded to 74,502,510 analyses performed in 585,745 distinct adult patients \>20y

Brief summary: The investigators conducted a retrospective analysis of all measured concentrations performed in a large subset of laboratories located in the French Brittany from February 2010 the 17th to August 2015 the 30th, in adults over 20 years old.

The investigators are aimed at studying physicians' use and eventually misuse of biomarkers dosage and the characteristics of a broad population based on some biomarkers concentrations.

Detailed description: The rUBIDIuM study is a retrospective analysis that included all tests (but not including DNA analysis or HIV tests) performed in a large subset of laboratories located in the French Brittany from February 2010 the 17th to August 2015 the 30th. The area of study covers most of the Ille-et-Vilaine and a part of the Côtes d'Armor department in Brittany. The respective surface of these departments is 6775 and 6878 km2. All labs belong to the Biorance Laboratory group (consortium of 33 labs, Biorance Laboratoires Réunis) and are equipped with Roche Diagnostics instruments (Elecsys2010® analyzer, Roche diagnostics, Meylan, France).

The main objectives are to study physicians' use and eventually misuse of biomarkers dosage and the characteristics of this broad population based on some biomarkers concentrations.

For all adult patients \>20y that came to a participating lab during the study period, the investigators collected the following information: demographics data, data about the prescription (date of order, list of analysis recommended, the date of blood collection and analysis), about the prescribers and the results of the analyses. After a de-identifying process, data were aggregated.

the initial analyses will 1) examine the biological tests (number, types...) ordered in a large cohort of patients, in the total population and the subgroups based on gender, age, time period, kind of lab and physicians' specialty, 2) examine the results/concentration of the analyses: blood chemistry, creatinin concentration, cardiac enzymes, natriuretic peptides, INR, lipid profile, hemogram...

Eligibility criteria: Inclusion Criteria:

* All adult patients \>20 that came to a participating lab (Biorance Laboratoires Réunis) during the study period for biological measurement

Exclusion Criteria:

* DNA analysis, HIV test

Primary outcomes:
measure: biomarker dosage prescription
timeFrame: August 2017
Secondary outcomes:
measure: Biomarkers dosage numbers
timeFrame: August 2017
measure: Biomarkers in geriatric patients
timeFrame: August 2017
measure: Population's characteristics
timeFrame: August 2017
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Avicenne Hospital
Study officials:
affiliation: Avicenne Hospital
name: Christophe Meune, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: