OptimisAtion of Diagnostic Accuracy in IdioPathic InflammaTory Myopathies (ADAPT Study): a Protocol for a Prospective Diagnostic Accuracy Study of Multimodality Testing in Patients Suspected of a Treatable Idiopathic Inflammatory Myopathy

Overview

Journal BMJ Open

Specialty General Medicine

Date 2021 Dec 14

PMID 34903547

Citations 1

Authors

Hannah A W Walter

Renske G Kamperman

Joost Raaphorst

Camiel Verhamme

Johannes H T M Koelman

Wouter V Potters

Robert Hemke

Frank F Smithuis

Eleonora Aronica

Ester M M van Leeuwen

Paul A Baars

Marianne de Visser

Ivo N van Schaik

Patrick M M Bossuyt

Anneke J van der Kooi

Affiliations

Soon will be listed here.

Abstract

Introduction: Idiopathic inflammatory myopathies (IIMs) excluding inclusion body myositis (IBM) are a group of heterogeneous autoimmune disorders characterised by subacute-onset and progressive proximal muscle weakness, which are frequently part of a multisystem autoimmune disorder. Reaching the diagnosis can be challenging, and no gold standard for the diagnosis of IIM exists. Diagnostic modalities include serum creatine kinase activity, muscle imaging (MRI or ultrasound (US)), electromyography (EMG), myositis autoantibody testing and muscle biopsy. Several diagnostic criteria have been developed for IIMs, varying in reported sensitivity and specificity.

Hypothesis: We hypothesise that an evidence-based diagnostic strategy, using fewer and preferably the least invasive diagnostic modalities, can achieve the accuracy of a complete panel of diagnostic tests, including MRI, US, EMG, myositis-specific autoantibody testing and muscle biopsy.

Methods And Analysis: The OptimizAtion of Diagnostic Accuracy in idioPathic inflammaTory myopathies study is a prospective diagnostic accuracy study with an over-complete study design. 100 patients suspected of an IIM excluding IBM will be included. A reference diagnosis will be assigned by an expert panel using all clinical information and all results of all ancillary tests available, including 6 months of follow-up. Several predefined diagnostic strategies will be compared against the reference diagnosis to find the optimal diagnostic strategy.

Ethics And Dissemination: Ethical approval was obtained from the medical ethics committee of the Academic Medical Centre, University of Amsterdam, The Netherlands (2019-814). The results will be distributed through conference presentations and peer-reviewed publications.

Trial Registration Number: Netherlands trial register; NL8764.

Citing Articles

Treatment with add-on IVIg in Myositis Early In the diSease course May be sUperior to Steroids alone for reaching CLinical improvEment (TIME IS MUSCLE): study protocol of a phase-2 double-blind placebo-controlled randomised trial.

Kamperman R, Bogaards J, Evers S, Walter H, de Visser M, de Borgie C BMJ Open. 2023; 13(7):e067435.

PMID: 37429682 PMC: 10335467. DOI: 10.1136/bmjopen-2022-067435.

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