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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02409251
Recruitment Status : Completed
First Posted : April 6, 2015
Last Update Posted : April 6, 2015
Information provided by (Responsible Party):
Nienke Lesuis, 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.

Condition or disease Intervention/treatment Phase
Rheumatic Diseases Behavioral: Education and feedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Requesting Behaviour of Rheumatologists Regarding Antinuclear Antibodies (ANA) in Patients With Rheumatologic Complaints
Study Start Date : February 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Experimental: Education and feedback
The intervention consisted of a one-hour, small group educational session. During this session information on rational ANA testing was provided and feedback on current ANA testing was provided to the rheumatologists. A booster session with the same components was held 6 months after the first session.
Behavioral: Education and feedback

Primary Outcome Measures :
  1. Change from baseline (pre-intervention) ANA/new patient ratio (APR) at 12 months (post-intervention) [ Time Frame: Pre- and post-intervention (both 12 months) ]
    Number of ANA tests divided by the number of new patients

  2. Change from baseline (pre-intervention) % of positive ANA tests at 12 months (post-intervention) [ Time Frame: 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.

  3. Change from baseline (pre-intervention) % of repeated ANA testing at 12 months (post-intervention) [ Time Frame: Pre- and post-intervention (both 12 months) ]
    Percentage of patients with ≥1 ANA test in 12 months (pre- or post-intervention period)

  4. Change from baseline (pre-intervention) % of ANA associated diagnoses at 12 months (post-intervention) [ Time Frame: 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

  5. Change from baseline (pre-intervention) APR variation between rheumatologists at 12 months (post-intervention) [ Time Frame: Pre- and post-intervention (both 12 months) ]
    Standard deviation around the mean APR, calculated from the APRs of the individual rheumatologists

  6. Change from baseline (pre-intervention) reaching the of target APR at 12 months (post-intervention) [ Time Frame: Pre- and post-intervention (both 12 months) ]
    Difference (percentage) between the actual APR and the target-APR defined during the intervention

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts 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

Exclusion Criteria patients

- patients with an ANA test requested during a clinical admission

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02409251

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Sint Maartenskliniek
Nijmegen, Gelderland, Netherlands, 6500 GM
Radboud University Medical Center
Nijmegen, Netherlands
Maartenskliniek Woerden
Woerden, Netherlands
Sponsors and Collaborators
Sint Maartenskliniek
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Principal Investigator: Ronald van Vollenhoven, MD, PhD Karolinska Institutet
Principal Investigator: Marlies Hulscher, PhD Scientific Institute for Quality of Healthcare, Radboud University Medical Center, Nijmegen, the Netherlands
Principal Investigator: Alfons den Broeder, MD, PhD Sint Maartenskliniek, Nijmegen, the Netherlands
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nienke Lesuis, MD, Sint Maartenskliniek Identifier: NCT02409251    
Other Study ID Numbers: RR-103-ANA
First Posted: April 6, 2015    Key Record Dates
Last Update Posted: April 6, 2015
Last Verified: March 2015
Keywords provided by Nienke Lesuis, Sint Maartenskliniek:
Antinuclear antibody (ANA)
Quality of care
Additional relevant MeSH terms:
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Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases