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MRI-based screening for structural definition of eligibility in clinical DMOAD trials: Rapid OsteoArthritis MRI Eligibility Score (ROAMES)
Our aim was to introduce a simplified MRI instrument, Rapid OsteoArthritis MRI Eligibility Score (ROAMES), for defining structural eligibility of patients for inclusion in disease-modifying osteoarthritis drug trials using a tri-compartmental anatomic approach that enables stratification of knees in...
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Published in: | Osteoarthritis and cartilage 2020-01, Vol.28 (1), p.71-81 |
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container_title | Osteoarthritis and cartilage |
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description | Our aim was to introduce a simplified MRI instrument, Rapid OsteoArthritis MRI Eligibility Score (ROAMES), for defining structural eligibility of patients for inclusion in disease-modifying osteoarthritis drug trials using a tri-compartmental anatomic approach that enables stratification of knees into different structural phenotypes and includes diagnoses of exclusion. We also aimed to define overlap between phenotypes and determine reliability.
50 knees from the Foundation for National Institutes of Health Osteoarthritis Biomarkers study, a nested case-control study within the Osteoarthritis Initiative, were selected within pre-defined definitions of phenotypes as either inflammatory, subchondral bone, meniscus/cartilage, atrophic or hypertrophic. A focused scoring instrument was developed covering cartilage, meniscal damage, inflammation and osteophytes. Diagnoses of exclusion were meniscal root tears, osteonecrosis, subchondral insufficiency fracture, tumors, malignant marrow infiltration and acute traumatic changes. Reliability was determined using weighted kappa statistics. Descriptive statistics were used for determining concordance between the a priori phenotypic definition and ROAMES and overlap between phenotypes.
ROAMES identified 43 of 50 (86%) pre-defined phenotypes correctly. Of the 50 participants, 27 (54%) had no additional phenotypes other than the pre-defined phenotype. 18 (36%) had one and 5 (10%) had two additional phenotypes. None had three or four additional phenotypes. All features of ROAMES showed almost perfect agreement. One case with osteonecrosis and one with a tumor were detected.
ROAMES is able to screen and stratify potentially eligible knees into different structural phenotypes and record relevant diagnoses of exclusion. Reliability of the instrument showed almost perfect agreement. |
doi_str_mv | 10.1016/j.joca.2019.08.005 |
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50 knees from the Foundation for National Institutes of Health Osteoarthritis Biomarkers study, a nested case-control study within the Osteoarthritis Initiative, were selected within pre-defined definitions of phenotypes as either inflammatory, subchondral bone, meniscus/cartilage, atrophic or hypertrophic. A focused scoring instrument was developed covering cartilage, meniscal damage, inflammation and osteophytes. Diagnoses of exclusion were meniscal root tears, osteonecrosis, subchondral insufficiency fracture, tumors, malignant marrow infiltration and acute traumatic changes. Reliability was determined using weighted kappa statistics. Descriptive statistics were used for determining concordance between the a priori phenotypic definition and ROAMES and overlap between phenotypes.
ROAMES identified 43 of 50 (86%) pre-defined phenotypes correctly. Of the 50 participants, 27 (54%) had no additional phenotypes other than the pre-defined phenotype. 18 (36%) had one and 5 (10%) had two additional phenotypes. None had three or four additional phenotypes. All features of ROAMES showed almost perfect agreement. One case with osteonecrosis and one with a tumor were detected.
ROAMES is able to screen and stratify potentially eligible knees into different structural phenotypes and record relevant diagnoses of exclusion. Reliability of the instrument showed almost perfect agreement.</description><identifier>ISSN: 1063-4584</identifier><identifier>EISSN: 1522-9653</identifier><identifier>DOI: 10.1016/j.joca.2019.08.005</identifier><identifier>PMID: 31513920</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Aged ; Clinical trial ; Clinical Trials as Topic ; Eligibility ; Female ; Humans ; Knee Joint - diagnostic imaging ; Magnetic Resonance Imaging - methods ; Male ; Middle Aged ; MRI ; Osteoarthritis ; Osteoarthritis, Knee - classification ; Osteoarthritis, Knee - diagnosis ; Osteoarthritis, Knee - diagnostic imaging ; Patient Selection ; Severity of Illness Index</subject><ispartof>Osteoarthritis and cartilage, 2020-01, Vol.28 (1), p.71-81</ispartof><rights>2019 Osteoarthritis Research Society International</rights><rights>Copyright © 2019 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c455t-863be8fa7b440e6ec5738548c85aa52318682997e3861dbf55e5fe5d5276c4523</citedby><cites>FETCH-LOGICAL-c455t-863be8fa7b440e6ec5738548c85aa52318682997e3861dbf55e5fe5d5276c4523</cites><orcidid>0000-0001-9238-7350</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,315,786,790,891,27957,27958</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31513920$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Roemer, F.W.</creatorcontrib><creatorcontrib>Collins, J.</creatorcontrib><creatorcontrib>Kwoh, C.K.</creatorcontrib><creatorcontrib>Hannon, M.J.</creatorcontrib><creatorcontrib>Neogi, T.</creatorcontrib><creatorcontrib>Felson, D.T.</creatorcontrib><creatorcontrib>Hunter, D.J.</creatorcontrib><creatorcontrib>Lynch, J.A.</creatorcontrib><creatorcontrib>Guermazi, A.</creatorcontrib><title>MRI-based screening for structural definition of eligibility in clinical DMOAD trials: Rapid OsteoArthritis MRI Eligibility Score (ROAMES)</title><title>Osteoarthritis and cartilage</title><addtitle>Osteoarthritis Cartilage</addtitle><description>Our aim was to introduce a simplified MRI instrument, Rapid OsteoArthritis MRI Eligibility Score (ROAMES), for defining structural eligibility of patients for inclusion in disease-modifying osteoarthritis drug trials using a tri-compartmental anatomic approach that enables stratification of knees into different structural phenotypes and includes diagnoses of exclusion. We also aimed to define overlap between phenotypes and determine reliability.
50 knees from the Foundation for National Institutes of Health Osteoarthritis Biomarkers study, a nested case-control study within the Osteoarthritis Initiative, were selected within pre-defined definitions of phenotypes as either inflammatory, subchondral bone, meniscus/cartilage, atrophic or hypertrophic. A focused scoring instrument was developed covering cartilage, meniscal damage, inflammation and osteophytes. Diagnoses of exclusion were meniscal root tears, osteonecrosis, subchondral insufficiency fracture, tumors, malignant marrow infiltration and acute traumatic changes. Reliability was determined using weighted kappa statistics. Descriptive statistics were used for determining concordance between the a priori phenotypic definition and ROAMES and overlap between phenotypes.
ROAMES identified 43 of 50 (86%) pre-defined phenotypes correctly. Of the 50 participants, 27 (54%) had no additional phenotypes other than the pre-defined phenotype. 18 (36%) had one and 5 (10%) had two additional phenotypes. None had three or four additional phenotypes. All features of ROAMES showed almost perfect agreement. One case with osteonecrosis and one with a tumor were detected.
ROAMES is able to screen and stratify potentially eligible knees into different structural phenotypes and record relevant diagnoses of exclusion. Reliability of the instrument showed almost perfect agreement.</description><subject>Aged</subject><subject>Clinical trial</subject><subject>Clinical Trials as Topic</subject><subject>Eligibility</subject><subject>Female</subject><subject>Humans</subject><subject>Knee Joint - diagnostic imaging</subject><subject>Magnetic Resonance Imaging - methods</subject><subject>Male</subject><subject>Middle Aged</subject><subject>MRI</subject><subject>Osteoarthritis</subject><subject>Osteoarthritis, Knee - classification</subject><subject>Osteoarthritis, Knee - diagnosis</subject><subject>Osteoarthritis, Knee - diagnostic imaging</subject><subject>Patient Selection</subject><subject>Severity of Illness Index</subject><issn>1063-4584</issn><issn>1522-9653</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp9kc9uEzEQxlcIREvhBTggH8thF_9Z79oIIUVtgEqNIqVwtrze2XSizTq1nUp9BZ4aRylVuXCakeb7fTP2VxTvGa0YZc2nTbXxzlacMl1RVVEqXxSnTHJe6kaKl7mnjShrqeqT4k2MG0qpYIy-Lk4Ek0xoTk-L34vVVdnZCD2JLgBMOK3J4AOJKexd2gc7kh4GnDChn4gfCIy4xg5HTA8EJ-LGPHNZdblYzi5JCmjH-Jms7A57sowJ_Cyk25DxSPIuMn-G3zgfgJyvlrPF_Obj2-LVkFl491jPil_f5j8vfpTXy-9XF7Pr0tVSplI1ogM12LarawoNONkKJWvllLRWcsFUo7jWLQjVsL4bpAQ5gOwlb5vswMVZ8fXou9t3W-gdTCm_0uwCbm14MN6i-Xcy4a1Z-3vTciF13WaD80eD4O_2EJPZYnQwjnYCv4-Gc02VboTWWcqPUhd8jAGGpzWMmkOIZmMOIZpDiIYqk0PM0IfnBz4hf1PLgi9HAeRvukcIJjqEyUGPAVwyvcf_-f8BwhOu-A</recordid><startdate>20200101</startdate><enddate>20200101</enddate><creator>Roemer, F.W.</creator><creator>Collins, J.</creator><creator>Kwoh, C.K.</creator><creator>Hannon, M.J.</creator><creator>Neogi, T.</creator><creator>Felson, D.T.</creator><creator>Hunter, D.J.</creator><creator>Lynch, J.A.</creator><creator>Guermazi, A.</creator><general>Elsevier Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-9238-7350</orcidid></search><sort><creationdate>20200101</creationdate><title>MRI-based screening for structural definition of eligibility in clinical DMOAD trials: Rapid OsteoArthritis MRI Eligibility Score (ROAMES)</title><author>Roemer, F.W. ; Collins, J. ; Kwoh, C.K. ; Hannon, M.J. ; Neogi, T. ; Felson, D.T. ; Hunter, D.J. ; Lynch, J.A. ; Guermazi, A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c455t-863be8fa7b440e6ec5738548c85aa52318682997e3861dbf55e5fe5d5276c4523</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Aged</topic><topic>Clinical trial</topic><topic>Clinical Trials as Topic</topic><topic>Eligibility</topic><topic>Female</topic><topic>Humans</topic><topic>Knee Joint - diagnostic imaging</topic><topic>Magnetic Resonance Imaging - methods</topic><topic>Male</topic><topic>Middle Aged</topic><topic>MRI</topic><topic>Osteoarthritis</topic><topic>Osteoarthritis, Knee - classification</topic><topic>Osteoarthritis, Knee - diagnosis</topic><topic>Osteoarthritis, Knee - diagnostic imaging</topic><topic>Patient Selection</topic><topic>Severity of Illness Index</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Roemer, F.W.</creatorcontrib><creatorcontrib>Collins, J.</creatorcontrib><creatorcontrib>Kwoh, C.K.</creatorcontrib><creatorcontrib>Hannon, M.J.</creatorcontrib><creatorcontrib>Neogi, T.</creatorcontrib><creatorcontrib>Felson, D.T.</creatorcontrib><creatorcontrib>Hunter, D.J.</creatorcontrib><creatorcontrib>Lynch, J.A.</creatorcontrib><creatorcontrib>Guermazi, A.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Osteoarthritis and cartilage</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Roemer, F.W.</au><au>Collins, J.</au><au>Kwoh, C.K.</au><au>Hannon, M.J.</au><au>Neogi, T.</au><au>Felson, D.T.</au><au>Hunter, D.J.</au><au>Lynch, J.A.</au><au>Guermazi, A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>MRI-based screening for structural definition of eligibility in clinical DMOAD trials: Rapid OsteoArthritis MRI Eligibility Score (ROAMES)</atitle><jtitle>Osteoarthritis and cartilage</jtitle><addtitle>Osteoarthritis Cartilage</addtitle><date>2020-01-01</date><risdate>2020</risdate><volume>28</volume><issue>1</issue><spage>71</spage><epage>81</epage><pages>71-81</pages><issn>1063-4584</issn><eissn>1522-9653</eissn><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>content type line 23</notes><notes>Analysis and interpretation of the data: FWR, JEC, CKK, DJH, DTF, TN, MJH, JL, AG</notes><notes>Drafting of the article: FWR, JEC, CKK, DJH, DTF, TN, MJH, JL, AG</notes><notes>Collection and assembly of data: FWR; AG</notes><notes>Provision of study materials or patients: FWR; AG, JEC</notes><notes>Authors contributions</notes><notes>Obtaining of funding: n/a</notes><notes>(2) All authors contributed to drafting the article or revising it critically for important intellectual content.</notes><notes>(1) All authors were involved in the conception and design of the study, or acquisition of data, or analysis and interpretation of data.</notes><notes>Additional contributions</notes><notes>Statistical expertise: JEC, MJH</notes><notes>Responsibility for the integrity of the work as a whole, from inception to finished article, is taken by F. Roemer, MD.</notes><notes>(3) All authors gave their final approval of the manuscript to be submitted.</notes><abstract>Our aim was to introduce a simplified MRI instrument, Rapid OsteoArthritis MRI Eligibility Score (ROAMES), for defining structural eligibility of patients for inclusion in disease-modifying osteoarthritis drug trials using a tri-compartmental anatomic approach that enables stratification of knees into different structural phenotypes and includes diagnoses of exclusion. We also aimed to define overlap between phenotypes and determine reliability.
50 knees from the Foundation for National Institutes of Health Osteoarthritis Biomarkers study, a nested case-control study within the Osteoarthritis Initiative, were selected within pre-defined definitions of phenotypes as either inflammatory, subchondral bone, meniscus/cartilage, atrophic or hypertrophic. A focused scoring instrument was developed covering cartilage, meniscal damage, inflammation and osteophytes. Diagnoses of exclusion were meniscal root tears, osteonecrosis, subchondral insufficiency fracture, tumors, malignant marrow infiltration and acute traumatic changes. Reliability was determined using weighted kappa statistics. Descriptive statistics were used for determining concordance between the a priori phenotypic definition and ROAMES and overlap between phenotypes.
ROAMES identified 43 of 50 (86%) pre-defined phenotypes correctly. Of the 50 participants, 27 (54%) had no additional phenotypes other than the pre-defined phenotype. 18 (36%) had one and 5 (10%) had two additional phenotypes. None had three or four additional phenotypes. All features of ROAMES showed almost perfect agreement. One case with osteonecrosis and one with a tumor were detected.
ROAMES is able to screen and stratify potentially eligible knees into different structural phenotypes and record relevant diagnoses of exclusion. Reliability of the instrument showed almost perfect agreement.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>31513920</pmid><doi>10.1016/j.joca.2019.08.005</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0001-9238-7350</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Aged Clinical trial Clinical Trials as Topic Eligibility Female Humans Knee Joint - diagnostic imaging Magnetic Resonance Imaging - methods Male Middle Aged MRI Osteoarthritis Osteoarthritis, Knee - classification Osteoarthritis, Knee - diagnosis Osteoarthritis, Knee - diagnostic imaging Patient Selection Severity of Illness Index |
title | MRI-based screening for structural definition of eligibility in clinical DMOAD trials: Rapid OsteoArthritis MRI Eligibility Score (ROAMES) |
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