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

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 diag...

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Main Authors: Frank F Smithuis, Anneke J van der Kooi, Joost Raaphorst, Ivo N van Schaik, Marianne de Visser, Paul A Baars, Patrick M M Bossuyt, Eleonora Aronica, Johannes H T M Koelman, Camiel Verhamme, Hannah A W Walter, Renske G Kamperman, Wouter V Potters, Ester M M van Leeuwen
Format: Article
Language:English
Published: BMJ Publishing Group 2021-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/11/12/e053594.full
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author Frank F Smithuis
Anneke J van der Kooi
Joost Raaphorst
Ivo N van Schaik
Marianne de Visser
Paul A Baars
Patrick M M Bossuyt
Eleonora Aronica
Johannes H T M Koelman
Camiel Verhamme
Hannah A W Walter
Renske G Kamperman
Wouter V Potters
Ester M M van Leeuwen
author_facet Frank F Smithuis
Anneke J van der Kooi
Joost Raaphorst
Ivo N van Schaik
Marianne de Visser
Paul A Baars
Patrick M M Bossuyt
Eleonora Aronica
Johannes H T M Koelman
Camiel Verhamme
Hannah A W Walter
Renske G Kamperman
Wouter V Potters
Ester M M van Leeuwen
author_sort Frank F Smithuis
collection DOAJ
description 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.
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spelling doaj-art-0a7a6b918b3e4c00b566b9a5e8f68ebe2025-08-20T01:54:50ZengBMJ Publishing GroupBMJ Open2044-60552021-12-01111210.1136/bmjopen-2021-053594OptimisAtion 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 myopathyFrank F Smithuis0Anneke J van der Kooi1Joost Raaphorst2Ivo N van Schaik3Marianne de Visser4Paul A Baars5Patrick M M Bossuyt6Eleonora Aronica7Johannes H T M Koelman8Camiel Verhamme9Hannah A W Walter10Renske G Kamperman11Wouter V Potters12Ester M M van Leeuwen133 Amsterdam Collaboration for Health and Safety in Sports (ACHSS), AMC/VUmc IOC Research Center, Amsterdam, The NetherlandsDepartment of Neurology and Clinical Neurophysiology, Amsterdam UMC Locatie AMC, University of Amsterdam, Amsterdam, The Netherlands4 Department of Neurology, Amsterdam Neuroscience, Amsterdam UMC, Amsterdam, Noord-Holland, The NetherlandsDepartment of Neurology and Clinical Neurophysiology, Amsterdam UMC Locatie AMC, University of Amsterdam, Amsterdam, The NetherlandsDepartment of Neurology and Clinical Neurophysiology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, The NetherlandsDepartment of Experimental Immunology, Amsterdam Institute for Infection & Immunity, Amsterdam UMC, Amsterdam UMC Locatie AMC, Amsterdam, North Holland, The Netherlandsprofessor of clinical epidemiologyDepartment of (Neuro)Pathology, Amsterdam University Medical Centre, Amsterdam Neuroscience, Amsterdam UMC Locatie AMC, Amsterdam, North Holland, The NetherlandsDepartment of Neurology and Clinical Neurophysiology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam Neuroscience, Amsterdam UMC Locatie AMC, Amsterdam, The NetherlandsDepartment of Neurology and Clinical Neurophysiology, Amsterdam UMC Locatie AMC, University of Amsterdam, Amsterdam, The NetherlandsDepartment of Neurology and Clinical Neurophysiology, Amsterdam UMC Locatie AMC, University of Amsterdam, Amsterdam, The NetherlandsDepartment of Neurology and Clinical Neurophysiology, Amsterdam UMC Locatie AMC, University of Amsterdam, Amsterdam, The NetherlandsDepartment of Neurology and Clinical Neurophysiology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam Neuroscience, Amsterdam UMC Locatie AMC, Amsterdam, The NetherlandsDepartment of Experimental Immunology, Amsterdam Institute for Infection & Immunity, Amsterdam UMC, Amsterdam UMC Locatie AMC, Amsterdam, North Holland, The NetherlandsIntroduction 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.https://bmjopen.bmj.com/content/11/12/e053594.full
spellingShingle Frank F Smithuis
Anneke J van der Kooi
Joost Raaphorst
Ivo N van Schaik
Marianne de Visser
Paul A Baars
Patrick M M Bossuyt
Eleonora Aronica
Johannes H T M Koelman
Camiel Verhamme
Hannah A W Walter
Renske G Kamperman
Wouter V Potters
Ester M M van Leeuwen
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
BMJ Open
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url https://bmjopen.bmj.com/content/11/12/e053594.full
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