Big Data Analysis of the Use of bIomarkers Concentration

Inappropriate Prescribing Clinical Trial

— rUBIDIuM  

Official title:

Defining Use and Misuse of BIoMarkers Dosage and Trends in Observed Concentration Over Time: a BIg Data Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254472
• Other study ID #: 2017-003438-10
• Status: Completed
• Phase: N/A
• First received: August 16, 2017
• Last updated: August 18, 2017
• Start date: February 17, 2010
• Est. completion date: September 10, 2015

Study information

• Verified date: August 2017
• Source: Hospital Avicenne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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…

Recruitment information / eligibility

• Status: Completed
• Enrollment: 585745
• Est. completion date: September 10, 2015
• Est. primary completion date: August 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biological Markers
• Inappropriate Prescribing

Intervention

Diagnostic Test:
• Measured concentrations of biomarkers

Locations

Country	Name	City	State
France	Avicenne Hospital	Bobigny

Sponsors (4)

Lead Sponsor	Collaborator
Hospital Avicenne	Biorance Laboratoires Réunis, ProBayes, Roche Diagnostics

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biomarker dosage prescription	physicians' use and eventually misuse of biomarkers dosage	August 2017
Secondary	Biomarkers dosage numbers	Biomarkers dosage numbers before and after new treatments, released of guidelines, new tests...	August 2017
Secondary	Biomarkers in geriatric patients	biomarkers dosages and concentration in elderly/very elderly patients	August 2017
Secondary	Population's characteristics	physicians' use and eventually misuse of biomarkers dosage	August 2017