We hypothesize that an evidence based diagnostic algorithm, using fewer and preferably the least invasive diagnostic modalities can approach the accuracy of the complete panel of diagnostic tests.
ID
Source
Brief title
Health condition
Patients suspected of myositis
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare the diagnostic accuracy and patient burden of testing strategies in patients suspected for idiopathic inflammatory myopathy who qualify for treatment with corticosteroids. Diagnostic accuracy will be based reference diagnosis of an expert panel.
Secondary outcome
Cost-effectiveness analysis
Background summary
Idiopathic inflammatory myopathies (IIM) are a heterogeneous group of immune related diseases, that need to be treated with prednisone (with the exception of IBM). Because of heterogeneity, patients present with a range of clinical features, and a timely diagnosis is ofthen challenging. Several diagnostic guidelines exist, and many diagnostic modalities are recommended for diagnosis, although a gold standard is lacking. The full panel of diagnostic modalities includes, beside clinical history, anamnesis and laboratory tests, EMG, muscle ultrasound, MRI, muscle biopsy and determination of antibodies. We hypothesize that an evidence based diagnostic algorithm, using fewer and preferably the least invasive diagnostic modalities can approach the accuracy of the complete panel of diagnostic tests.
Study objective
We hypothesize that an evidence based diagnostic algorithm, using fewer and preferably the least invasive diagnostic modalities can approach the accuracy of the complete panel of diagnostic tests.
Study design
At baseline, 5 diagnostic tests will be performed, and a probability diagnosis (IIM yes/no) will be given. After six months, an expert panel will provide a reference diagnosis, based on the full diagnostic package + six months follow up.
Intervention
Full diagnostic panel: EMG, muscle ultrasound, muscle MRI, muscle biopsy, determination of antibodies
Inclusion criteria
•Suspected idiopathic inflammatory myopathy •Symmetrical proximal muscle weakness causing functional limitation •Start of symptoms ≤24 months •Indication for treatment with corticosteroids •Minimum age of 18 years •Patient is mentally competent •Follow up of 6 months is possible
Exclusion criteria
• Other clear cause for proximal muscle weakness, i.e. the use of myotoxic medication, high suspicion for an inflammatory neuropathy (CIDP) or a positive family history for a hereditary neuromuscular disease • A high suspicion for sporadic inclusion body myositis (sIBM) • High suspicion on a neurogenic cause • Immunosuppressive treatment, with the exception of prednison up to 60mg since 2 weeks. • Previous history of myositis • Contraindications for MRI, claustrophobia • No consent for muscle biopsy
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8764 |
| CCMO | NL72219.018.19 |
| OMON | NL-OMON55232 |