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
IntroductionIdiopathic 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 diagn...
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| creator | Walter, Hannah A W Kamperman, Renske G Raaphorst, Joost Verhamme, Camiel Koelman, Johannes H T M Potters, Wouter V Hemke, Robert Smithuis, Frank F Aronica, Eleonora van Leeuwen, Ester M M Baars, Paul A de Visser, Marianne van Schaik, Ivo N Bossuyt, Patrick M M van der Kooi, Anneke J |
| description | IntroductionIdiopathic 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.HypothesisWe 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 analysisThe 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 disseminationEthical 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 numberNetherlands trial register; NL8764. |
| doi_str_mv | 10.1136/bmjopen-2021-053594 |
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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.HypothesisWe 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 analysisThe 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 disseminationEthical 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 numberNetherlands trial register; NL8764.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2021-053594</identifier><identifier>PMID: 34903547</identifier><language>eng</language><publisher>LONDON: British Medical Journal Publishing Group</publisher><subject>Accuracy ; Autoantibodies ; Autoimmune Diseases - diagnosis ; Biopsy ; Cardiomyopathy ; Connective tissue ; Consent ; Diagnostic tests ; Dysphagia ; Electromyography ; Evidence-Based Medicine ; General & Internal Medicine ; Humans ; Inflammatory diseases ; Laboratories ; Life Sciences & Biomedicine ; Magnetic resonance imaging ; Medical diagnosis ; Medical referrals ; Medicine, General & Internal ; Musculoskeletal diseases ; Myositis - diagnosis ; neuromuscular disease ; neuropathology ; Patients ; Prospective Studies ; radiology & imaging ; Rheumatology ; Science & Technology ; Ultrasonic imaging ; ultrasound</subject><ispartof>BMJ open, 2021-12, Vol.11 (12), p.e053594-e053594, Article 053594</ispartof><rights>Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>2021 Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>true</woscitedreferencessubscribed><woscitedreferencescount>1</woscitedreferencescount><woscitedreferencesoriginalsourcerecordid>wos000730332700015</woscitedreferencesoriginalsourcerecordid><citedby>FETCH-LOGICAL-b473t-d7bad93e7ca315625dade4b202df81efbdd12ff133541229c5a579c1e3caf43b3</citedby><cites>FETCH-LOGICAL-b473t-d7bad93e7ca315625dade4b202df81efbdd12ff133541229c5a579c1e3caf43b3</cites><orcidid>0000-0001-9106-0508</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://bmjopen.bmj.com/content/11/12/e053594.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://bmjopen.bmj.com/content/11/12/e053594.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,315,729,782,786,866,887,2116,27931,27932,39265,53798,53800,55357,77668,77694</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34903547$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Walter, Hannah A W</creatorcontrib><creatorcontrib>Kamperman, Renske G</creatorcontrib><creatorcontrib>Raaphorst, Joost</creatorcontrib><creatorcontrib>Verhamme, Camiel</creatorcontrib><creatorcontrib>Koelman, Johannes H T M</creatorcontrib><creatorcontrib>Potters, Wouter V</creatorcontrib><creatorcontrib>Hemke, Robert</creatorcontrib><creatorcontrib>Smithuis, Frank F</creatorcontrib><creatorcontrib>Aronica, Eleonora</creatorcontrib><creatorcontrib>van Leeuwen, Ester M M</creatorcontrib><creatorcontrib>Baars, Paul A</creatorcontrib><creatorcontrib>de Visser, Marianne</creatorcontrib><creatorcontrib>van Schaik, Ivo N</creatorcontrib><creatorcontrib>Bossuyt, Patrick M M</creatorcontrib><creatorcontrib>van der Kooi, Anneke J</creatorcontrib><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><title>BMJ open</title><addtitle>BMJ Open</addtitle><addtitle>BMJ OPEN</addtitle><addtitle>BMJ Open</addtitle><description>IntroductionIdiopathic 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.HypothesisWe 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 analysisThe 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 disseminationEthical 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 numberNetherlands trial register; NL8764.</description><subject>Accuracy</subject><subject>Autoantibodies</subject><subject>Autoimmune Diseases - diagnosis</subject><subject>Biopsy</subject><subject>Cardiomyopathy</subject><subject>Connective tissue</subject><subject>Consent</subject><subject>Diagnostic tests</subject><subject>Dysphagia</subject><subject>Electromyography</subject><subject>Evidence-Based Medicine</subject><subject>General & Internal Medicine</subject><subject>Humans</subject><subject>Inflammatory diseases</subject><subject>Laboratories</subject><subject>Life Sciences & Biomedicine</subject><subject>Magnetic resonance imaging</subject><subject>Medical diagnosis</subject><subject>Medical referrals</subject><subject>Medicine, General & Internal</subject><subject>Musculoskeletal diseases</subject><subject>Myositis - diagnosis</subject><subject>neuromuscular disease</subject><subject>neuropathology</subject><subject>Patients</subject><subject>Prospective Studies</subject><subject>radiology & imaging</subject><subject>Rheumatology</subject><subject>Science & Technology</subject><subject>Ultrasonic 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Hannah A W</creator><creator>Kamperman, Renske G</creator><creator>Raaphorst, Joost</creator><creator>Verhamme, Camiel</creator><creator>Koelman, Johannes H T M</creator><creator>Potters, Wouter V</creator><creator>Hemke, Robert</creator><creator>Smithuis, Frank F</creator><creator>Aronica, Eleonora</creator><creator>van Leeuwen, Ester M M</creator><creator>Baars, Paul A</creator><creator>de Visser, Marianne</creator><creator>van Schaik, Ivo N</creator><creator>Bossuyt, Patrick M M</creator><creator>van der Kooi, Anneke J</creator><general>British Medical Journal Publishing Group</general><general>Bmj Publishing Group</general><general>BMJ Publishing Group LTD</general><general>BMJ Publishing 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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><author>Walter, Hannah A W ; Kamperman, Renske G ; Raaphorst, Joost ; Verhamme, Camiel ; Koelman, Johannes H T M ; Potters, Wouter V ; Hemke, Robert ; Smithuis, Frank F ; Aronica, Eleonora ; van Leeuwen, Ester M M ; Baars, Paul A ; de Visser, Marianne ; van Schaik, Ivo N ; Bossuyt, Patrick M M ; van der Kooi, Anneke J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b473t-d7bad93e7ca315625dade4b202df81efbdd12ff133541229c5a579c1e3caf43b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Accuracy</topic><topic>Autoantibodies</topic><topic>Autoimmune Diseases - diagnosis</topic><topic>Biopsy</topic><topic>Cardiomyopathy</topic><topic>Connective tissue</topic><topic>Consent</topic><topic>Diagnostic tests</topic><topic>Dysphagia</topic><topic>Electromyography</topic><topic>Evidence-Based Medicine</topic><topic>General & Internal Medicine</topic><topic>Humans</topic><topic>Inflammatory diseases</topic><topic>Laboratories</topic><topic>Life Sciences & Biomedicine</topic><topic>Magnetic resonance imaging</topic><topic>Medical diagnosis</topic><topic>Medical referrals</topic><topic>Medicine, General & Internal</topic><topic>Musculoskeletal diseases</topic><topic>Myositis - diagnosis</topic><topic>neuromuscular disease</topic><topic>neuropathology</topic><topic>Patients</topic><topic>Prospective Studies</topic><topic>radiology & imaging</topic><topic>Rheumatology</topic><topic>Science & Technology</topic><topic>Ultrasonic imaging</topic><topic>ultrasound</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Walter, Hannah A W</creatorcontrib><creatorcontrib>Kamperman, Renske 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Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Walter, Hannah A W</au><au>Kamperman, Renske G</au><au>Raaphorst, Joost</au><au>Verhamme, Camiel</au><au>Koelman, Johannes H T M</au><au>Potters, Wouter V</au><au>Hemke, Robert</au><au>Smithuis, Frank F</au><au>Aronica, Eleonora</au><au>van Leeuwen, Ester M M</au><au>Baars, Paul A</au><au>de Visser, Marianne</au><au>van Schaik, Ivo N</au><au>Bossuyt, Patrick M M</au><au>van der Kooi, Anneke J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>BMJ open</jtitle><stitle>BMJ Open</stitle><stitle>BMJ OPEN</stitle><addtitle>BMJ Open</addtitle><date>2021-12-13</date><risdate>2021</risdate><volume>11</volume><issue>12</issue><spage>e053594</spage><epage>e053594</epage><pages>e053594-e053594</pages><artnum>053594</artnum><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>IntroductionIdiopathic 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.HypothesisWe 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 analysisThe 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 disseminationEthical 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 numberNetherlands trial register; NL8764.</abstract><cop>LONDON</cop><pub>British Medical Journal Publishing Group</pub><pmid>34903547</pmid><doi>10.1136/bmjopen-2021-053594</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0001-9106-0508</orcidid><oa>free_for_read</oa></addata></record> |
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| source | BMJ Open Access Journals; MEDLINE; DOAJ Directory of Open Access Journals; PubMed Central Open Access; Web of Science - Science Citation Index Expanded - 2021<img src="https://exlibris-pub.s3.amazonaws.com/fromwos-v2.jpg" />; EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Accuracy Autoantibodies Autoimmune Diseases - diagnosis Biopsy Cardiomyopathy Connective tissue Consent Diagnostic tests Dysphagia Electromyography Evidence-Based Medicine General & Internal Medicine Humans Inflammatory diseases Laboratories Life Sciences & Biomedicine Magnetic resonance imaging Medical diagnosis Medical referrals Medicine, General & Internal Musculoskeletal diseases Myositis - diagnosis neuromuscular disease neuropathology Patients Prospective Studies radiology & imaging Rheumatology Science & Technology Ultrasonic imaging ultrasound |
| 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 |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-04T12%3A39%3A24IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=OptimisAtion%20of%20Diagnostic%20Accuracy%20in%20idioPathic%20inflammaTory%20myopathies%20(ADAPT%20study):%20a%20protocol%20for%20a%20prospective%20diagnostic%20accuracy%20study%20of%20multimodality%20testing%20in%20patients%20suspected%20of%20a%20treatable%20idiopathic%20inflammatory%20myopathy&rft.jtitle=BMJ%20open&rft.au=Walter,%20Hannah%20A%20W&rft.date=2021-12-13&rft.volume=11&rft.issue=12&rft.spage=e053594&rft.epage=e053594&rft.pages=e053594-e053594&rft.artnum=053594&rft.issn=2044-6055&rft.eissn=2044-6055&rft_id=info:doi/10.1136/bmjopen-2021-053594&rft_dat=%3Cproquest_cross%3E2610079401%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2609566347&rft_id=info:pmid/34903547&rfr_iscdi=true |