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

Requesting Behaviour of Rheumatologists Regarding Antinuclear Antibodies (ANA) in Patients With Rheumatologic Complaints

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02409251
Enrollment
29
Registered
2015-04-06
Start date
2012-02-29
Completion date
2014-07-31
Last updated
2015-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatic Diseases

Keywords

Antinuclear antibody (ANA), Overuse, Rheumatologists, Quality of care

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.

Interventions

Sponsors

Sint Maartenskliniek
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

rheumatologists: * rheumatologists who are consulting patients at the rheumatology outpatient clinic of a participating centre

Exclusion criteria

rheumatologists: * rheumatologists not working the full study period (pre- and post-intervention) at a participating centre * rheumatologists not giving their consent to participate Inclusion Criteria patients - all patients with an ANA test requested by an included rheumatologist during the study period

Design outcomes

Primary

MeasureTime frameDescription
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) % 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) % 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) 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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026