Rheumatologists and the Requesting of Antinuclear Antibodies (ANA) Tests in Patients With Rheumatologic Complaints

Not Applicable

Completed

• Conditions: Rheumatic Diseases

• Registration Number: NCT02409251
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

The aim of this study is to assess the effect of a simple intervention (a combination of education and feedback) on Antinuclear Antibody (ANA) testing.

This aim was chosen because of the known overuse of many laboratory tests, of which ANA testing is one. As overuse of ANA tests can have negative consequences (both for patients and society), the investigators designed an intervention to see how this would influence Antinuclear Antibody testing by rheumatologists.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2014-01
• Study Completion: 2014-07
• Status Verified: 2015-03
• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-31
• Last Update Submitted: 2015-03-31
• Study First Posted: 2015-04-06
• Last Update Posted: 2015-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline (pre-intervention) % of repeated ANA testing at 12 months (post-intervention)	Pre- and post-intervention (both 12 months)	Percentage of patients with ≥1 ANA test in 12 months (pre- or post-intervention period)
Change from baseline (pre-intervention) % of ANA associated diagnoses at 12 months (post-intervention)	Pre- and post-intervention (both 12 months)	Percentage of patients, in which an ANA is done during the study period, with final diagnosis of SLE, SSc, PM/DM, MCTD or SS
Change from baseline (pre-intervention) APR variation between rheumatologists at 12 months (post-intervention)	Pre- and post-intervention (both 12 months)	Standard deviation around the mean APR, calculated from the APRs of the individual rheumatologists
Change from baseline (pre-intervention) % of positive ANA tests at 12 months (post-intervention)	Pre- and post-intervention (both 12 months)	Percentage of ANA tests reported as positive by the local laboratory. ANA tests reported as 'weakly positive' are regarded as negative.
Change from baseline (pre-intervention) ANA/new patient ratio (APR) at 12 months (post-intervention)	Pre- and post-intervention (both 12 months)	Number of ANA tests divided by the number of new patients
Change from baseline (pre-intervention) reaching the of target APR at 12 months (post-intervention)	Pre- and post-intervention (both 12 months)	Difference (percentage) between the actual APR and the target-APR defined during the intervention

Trial Locations

Locations (3)

Sint Maartenskliniek; 🇳🇱 Nijmegen, Gelderland, Netherlands

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands

Maartenskliniek Woerden; 🇳🇱 Woerden, Netherlands