The 6-minute walk test and other clinical endpoints in duchenne muscular dystrophy: Reliability, concurrent validity, and minimal clinically important differences from a multicenter study
ABSTRACT Introduction: An international clinical trial enrolled 174 ambulatory males ≥5 years old with nonsense mutation Duchenne muscular dystrophy (nmDMD). Pretreatment data provide insight into reliability, concurrent validity, and minimal clinically important differences (MCIDs) of the 6‐minute...
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| Veröffentlicht in: | Muscle & nerve 2013-09, Vol.48 (3), p.357-368 |
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| creator | McDonald, Craig M. Henricson, Erik K. Abresch, R. Ted Florence, Julaine Eagle, Michelle Gappmaier, Eduard Glanzman, Allan M. Spiegel, Robert Barth, Jay Elfring, Gary Reha, Allen Peltz, Stuart W. |
| description | ABSTRACT
Introduction: An international clinical trial enrolled 174 ambulatory males ≥5 years old with nonsense mutation Duchenne muscular dystrophy (nmDMD). Pretreatment data provide insight into reliability, concurrent validity, and minimal clinically important differences (MCIDs) of the 6‐minute walk test (6MWT) and other endpoints. Methods: Screening and baseline evaluations included the 6‐minute walk distance (6MWD), timed function tests (TFTs), quantitative strength by myometry, the PedsQL, heart rate–determined energy expenditure index, and other exploratory endpoints. Results: The 6MWT proved feasible and reliable in a multicenter context. Concurrent validity with other endpoints was excellent. The MCID for 6MWD was 28.5 and 31.7 meters based on 2 statistical distribution methods. Conclusions: The ratio of MCID to baseline mean is lower for 6MWD than for other endpoints. The 6MWD is an optimal primary endpoint for Duchenne muscular dystrophy (DMD) clinical trials that are focused therapeutically on preservation of ambulation and slowing of disease progression. Muscle Nerve 48: 357–368, 2013 |
| doi_str_mv | 10.1002/mus.23905 |
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Introduction: An international clinical trial enrolled 174 ambulatory males ≥5 years old with nonsense mutation Duchenne muscular dystrophy (nmDMD). Pretreatment data provide insight into reliability, concurrent validity, and minimal clinically important differences (MCIDs) of the 6‐minute walk test (6MWT) and other endpoints. Methods: Screening and baseline evaluations included the 6‐minute walk distance (6MWD), timed function tests (TFTs), quantitative strength by myometry, the PedsQL, heart rate–determined energy expenditure index, and other exploratory endpoints. Results: The 6MWT proved feasible and reliable in a multicenter context. Concurrent validity with other endpoints was excellent. The MCID for 6MWD was 28.5 and 31.7 meters based on 2 statistical distribution methods. Conclusions: The ratio of MCID to baseline mean is lower for 6MWD than for other endpoints. The 6MWD is an optimal primary endpoint for Duchenne muscular dystrophy (DMD) clinical trials that are focused therapeutically on preservation of ambulation and slowing of disease progression. Muscle Nerve 48: 357–368, 2013</description><identifier>ISSN: 0148-639X</identifier><identifier>ISSN: 1097-4598</identifier><identifier>EISSN: 1097-4598</identifier><identifier>DOI: 10.1002/mus.23905</identifier><identifier>PMID: 23674289</identifier><identifier>CODEN: MUNEDE</identifier><language>eng</language><publisher>United States: Blackwell Publishing Ltd</publisher><subject>6-minute walk test ; ambulation ; Annan medicin och hälsovetenskap ; diagnosis ; Disease Progression ; drug effects ; drug therapy ; Duchenne ; Duchenne muscular dystrophy ; energy expenditure index ; Exercise Test ; Heart Rate ; Heart Rate - drug effects ; Heart Rate - physiology ; Humans ; Main ; Male ; Muscular Dystrophy ; Muscular Dystrophy, Duchenne - diagnosis ; Muscular Dystrophy, Duchenne - drug therapy ; Muscular Dystrophy, Duchenne - physiopathology ; myometry ; natural history ; Other Medical and Health Sciences ; Outcome Assessment, Health Care ; Oxadiazoles ; Oxadiazoles - therapeutic use ; PedsQL ; physiology ; physiopathology ; Reproducibility of Results ; therapeutic use ; Time Factors ; timed function test ; Validity ; Walking ; Walking - physiology</subject><ispartof>Muscle & nerve, 2013-09, Vol.48 (3), p.357-368</ispartof><rights>Copyright © 2013 Wiley Periodicals, Inc.</rights><rights>Copyright © 2013 Wiley Periodicals, Inc. 2013</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c6635-10a5f7e8acaba7d9f836e611313974ff67acedae3c4ed70f17481f24ba8326af3</citedby><cites>FETCH-LOGICAL-c6635-10a5f7e8acaba7d9f836e611313974ff67acedae3c4ed70f17481f24ba8326af3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fmus.23905$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fmus.23905$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,550,776,780,881,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23674289$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://gup.ub.gu.se/publication/188393$$DView record from Swedish Publication Index$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:127892546$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>McDonald, Craig M.</creatorcontrib><creatorcontrib>Henricson, Erik K.</creatorcontrib><creatorcontrib>Abresch, R. Ted</creatorcontrib><creatorcontrib>Florence, Julaine</creatorcontrib><creatorcontrib>Eagle, Michelle</creatorcontrib><creatorcontrib>Gappmaier, Eduard</creatorcontrib><creatorcontrib>Glanzman, Allan M.</creatorcontrib><creatorcontrib>Spiegel, Robert</creatorcontrib><creatorcontrib>Barth, Jay</creatorcontrib><creatorcontrib>Elfring, Gary</creatorcontrib><creatorcontrib>Reha, Allen</creatorcontrib><creatorcontrib>Peltz, Stuart W.</creatorcontrib><creatorcontrib>PTC124-GD-007-DMD Study Group</creatorcontrib><creatorcontrib>PTC124‐GD‐007‐DMD Study Group</creatorcontrib><title>The 6-minute walk test and other clinical endpoints in duchenne muscular dystrophy: Reliability, concurrent validity, and minimal clinically important differences from a multicenter study</title><title>Muscle & nerve</title><addtitle>Muscle Nerve</addtitle><description>ABSTRACT
Introduction: An international clinical trial enrolled 174 ambulatory males ≥5 years old with nonsense mutation Duchenne muscular dystrophy (nmDMD). Pretreatment data provide insight into reliability, concurrent validity, and minimal clinically important differences (MCIDs) of the 6‐minute walk test (6MWT) and other endpoints. Methods: Screening and baseline evaluations included the 6‐minute walk distance (6MWD), timed function tests (TFTs), quantitative strength by myometry, the PedsQL, heart rate–determined energy expenditure index, and other exploratory endpoints. Results: The 6MWT proved feasible and reliable in a multicenter context. Concurrent validity with other endpoints was excellent. The MCID for 6MWD was 28.5 and 31.7 meters based on 2 statistical distribution methods. Conclusions: The ratio of MCID to baseline mean is lower for 6MWD than for other endpoints. The 6MWD is an optimal primary endpoint for Duchenne muscular dystrophy (DMD) clinical trials that are focused therapeutically on preservation of ambulation and slowing of disease progression. Muscle Nerve 48: 357–368, 2013</description><subject>6-minute walk test</subject><subject>ambulation</subject><subject>Annan medicin och hälsovetenskap</subject><subject>diagnosis</subject><subject>Disease Progression</subject><subject>drug effects</subject><subject>drug therapy</subject><subject>Duchenne</subject><subject>Duchenne muscular dystrophy</subject><subject>energy expenditure index</subject><subject>Exercise Test</subject><subject>Heart Rate</subject><subject>Heart Rate - drug effects</subject><subject>Heart Rate - physiology</subject><subject>Humans</subject><subject>Main</subject><subject>Male</subject><subject>Muscular Dystrophy</subject><subject>Muscular Dystrophy, Duchenne - diagnosis</subject><subject>Muscular Dystrophy, Duchenne - drug therapy</subject><subject>Muscular Dystrophy, Duchenne - physiopathology</subject><subject>myometry</subject><subject>natural history</subject><subject>Other Medical and Health Sciences</subject><subject>Outcome Assessment, Health Care</subject><subject>Oxadiazoles</subject><subject>Oxadiazoles - therapeutic use</subject><subject>PedsQL</subject><subject>physiology</subject><subject>physiopathology</subject><subject>Reproducibility of Results</subject><subject>therapeutic use</subject><subject>Time Factors</subject><subject>timed function test</subject><subject>Validity</subject><subject>Walking</subject><subject>Walking - physiology</subject><issn>0148-639X</issn><issn>1097-4598</issn><issn>1097-4598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><sourceid>D8T</sourceid><recordid>eNp9kt9uFCEUxidGY7fVC1_AkHhl0mlhYBjGiyZmo1uTqlHb6B1hGdilyzAjMF3n2Xw52e6f2Au9AXL4ne87HE6WvUDwDEFYnLdDOCtwDctH2QTBuspJWbPH2QQiwnKK6x9H2XEItxBCxGj1NDsqMK1IwepJ9vt6qQDNW-OGqMBa2BWIKkQgXAO6uFQeSGuckcIC5Zq-My4GYBxoBrlUzimQvOVghQfNGKLv-uX4BnxV1oi5sSaOp0B2Tg7eKxfBnbCmuQ9u5JOnaZPu3sCOwLR956NIaGO0VilJqgC071ogkpONRiadVFSIQzM-y55oYYN6vttPspv3766nl_nV59mH6durXFKKyxxBUepKMSHFXFRNrRmmiiKEEa4rojWthFSNUFgS1VRQo4owpAsyFwwXVGh8kuVb3bBW_TDnvU91-5F3wvBdaJVOipdFTQj6L78Yep5Ci2HDI8ZwjRN_seUT3Kpm80Qv7IO0hzfOLPmiu-OYFRSWG4FXOwHf_RzS9_HbbvAu9YQjQnCJyrQm6vWWkr4LwSt9cECQb-aIp7_k93OU2Jd_l3Qg94OTgPMtsDZWjf9W4h9vvu0ld10xIapfhwzhV5xWuCr5908zPiOXlNEp5F_wH1C_6Vw</recordid><startdate>201309</startdate><enddate>201309</enddate><creator>McDonald, Craig M.</creator><creator>Henricson, Erik K.</creator><creator>Abresch, R. Ted</creator><creator>Florence, Julaine</creator><creator>Eagle, Michelle</creator><creator>Gappmaier, Eduard</creator><creator>Glanzman, Allan M.</creator><creator>Spiegel, Robert</creator><creator>Barth, Jay</creator><creator>Elfring, Gary</creator><creator>Reha, Allen</creator><creator>Peltz, Stuart W.</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><scope>24P</scope><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>7T5</scope><scope>7TK</scope><scope>7TM</scope><scope>7TS</scope><scope>7U7</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>5PM</scope><scope>ADTPV</scope><scope>AOWAS</scope><scope>F1U</scope><scope>D8T</scope><scope>ZZAVC</scope></search><sort><creationdate>201309</creationdate><title>The 6-minute walk test and other clinical endpoints in duchenne muscular dystrophy: Reliability, concurrent validity, and minimal clinically important differences from a multicenter study</title><author>McDonald, Craig M. ; Henricson, Erik K. ; Abresch, R. Ted ; Florence, Julaine ; Eagle, Michelle ; Gappmaier, Eduard ; Glanzman, Allan M. ; Spiegel, Robert ; Barth, Jay ; Elfring, Gary ; Reha, Allen ; Peltz, Stuart W.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c6635-10a5f7e8acaba7d9f836e611313974ff67acedae3c4ed70f17481f24ba8326af3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>6-minute walk test</topic><topic>ambulation</topic><topic>Annan medicin och hälsovetenskap</topic><topic>diagnosis</topic><topic>Disease Progression</topic><topic>drug effects</topic><topic>drug therapy</topic><topic>Duchenne</topic><topic>Duchenne muscular dystrophy</topic><topic>energy expenditure index</topic><topic>Exercise Test</topic><topic>Heart Rate</topic><topic>Heart Rate - drug effects</topic><topic>Heart Rate - physiology</topic><topic>Humans</topic><topic>Main</topic><topic>Male</topic><topic>Muscular Dystrophy</topic><topic>Muscular Dystrophy, Duchenne - diagnosis</topic><topic>Muscular Dystrophy, Duchenne - drug therapy</topic><topic>Muscular Dystrophy, Duchenne - physiopathology</topic><topic>myometry</topic><topic>natural history</topic><topic>Other Medical and Health Sciences</topic><topic>Outcome Assessment, Health Care</topic><topic>Oxadiazoles</topic><topic>Oxadiazoles - therapeutic use</topic><topic>PedsQL</topic><topic>physiology</topic><topic>physiopathology</topic><topic>Reproducibility of Results</topic><topic>therapeutic use</topic><topic>Time Factors</topic><topic>timed function test</topic><topic>Validity</topic><topic>Walking</topic><topic>Walking - physiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>McDonald, Craig M.</creatorcontrib><creatorcontrib>Henricson, Erik K.</creatorcontrib><creatorcontrib>Abresch, R. Ted</creatorcontrib><creatorcontrib>Florence, Julaine</creatorcontrib><creatorcontrib>Eagle, Michelle</creatorcontrib><creatorcontrib>Gappmaier, Eduard</creatorcontrib><creatorcontrib>Glanzman, Allan M.</creatorcontrib><creatorcontrib>Spiegel, Robert</creatorcontrib><creatorcontrib>Barth, Jay</creatorcontrib><creatorcontrib>Elfring, Gary</creatorcontrib><creatorcontrib>Reha, Allen</creatorcontrib><creatorcontrib>Peltz, Stuart W.</creatorcontrib><creatorcontrib>PTC124-GD-007-DMD Study Group</creatorcontrib><creatorcontrib>PTC124‐GD‐007‐DMD Study Group</creatorcontrib><collection>Istex</collection><collection>Wiley Online Library Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Physical Education Index</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>PubMed Central (Full Participant titles)</collection><collection>SwePub</collection><collection>SwePub Articles</collection><collection>SWEPUB Göteborgs universitet</collection><collection>SWEPUB Freely available online</collection><collection>SwePub Articles full text</collection><jtitle>Muscle & nerve</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>McDonald, Craig M.</au><au>Henricson, Erik K.</au><au>Abresch, R. Ted</au><au>Florence, Julaine</au><au>Eagle, Michelle</au><au>Gappmaier, Eduard</au><au>Glanzman, Allan M.</au><au>Spiegel, Robert</au><au>Barth, Jay</au><au>Elfring, Gary</au><au>Reha, Allen</au><au>Peltz, Stuart W.</au><aucorp>PTC124-GD-007-DMD Study Group</aucorp><aucorp>PTC124‐GD‐007‐DMD Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The 6-minute walk test and other clinical endpoints in duchenne muscular dystrophy: Reliability, concurrent validity, and minimal clinically important differences from a multicenter study</atitle><jtitle>Muscle & nerve</jtitle><addtitle>Muscle Nerve</addtitle><date>2013-09</date><risdate>2013</risdate><volume>48</volume><issue>3</issue><spage>357</spage><epage>368</epage><pages>357-368</pages><issn>0148-639X</issn><issn>1097-4598</issn><eissn>1097-4598</eissn><coden>MUNEDE</coden><abstract>ABSTRACT
Introduction: An international clinical trial enrolled 174 ambulatory males ≥5 years old with nonsense mutation Duchenne muscular dystrophy (nmDMD). Pretreatment data provide insight into reliability, concurrent validity, and minimal clinically important differences (MCIDs) of the 6‐minute walk test (6MWT) and other endpoints. Methods: Screening and baseline evaluations included the 6‐minute walk distance (6MWD), timed function tests (TFTs), quantitative strength by myometry, the PedsQL, heart rate–determined energy expenditure index, and other exploratory endpoints. Results: The 6MWT proved feasible and reliable in a multicenter context. Concurrent validity with other endpoints was excellent. The MCID for 6MWD was 28.5 and 31.7 meters based on 2 statistical distribution methods. Conclusions: The ratio of MCID to baseline mean is lower for 6MWD than for other endpoints. The 6MWD is an optimal primary endpoint for Duchenne muscular dystrophy (DMD) clinical trials that are focused therapeutically on preservation of ambulation and slowing of disease progression. Muscle Nerve 48: 357–368, 2013</abstract><cop>United States</cop><pub>Blackwell Publishing Ltd</pub><pmid>23674289</pmid><doi>10.1002/mus.23905</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | 6-minute walk test ambulation Annan medicin och hälsovetenskap diagnosis Disease Progression drug effects drug therapy Duchenne Duchenne muscular dystrophy energy expenditure index Exercise Test Heart Rate Heart Rate - drug effects Heart Rate - physiology Humans Main Male Muscular Dystrophy Muscular Dystrophy, Duchenne - diagnosis Muscular Dystrophy, Duchenne - drug therapy Muscular Dystrophy, Duchenne - physiopathology myometry natural history Other Medical and Health Sciences Outcome Assessment, Health Care Oxadiazoles Oxadiazoles - therapeutic use PedsQL physiology physiopathology Reproducibility of Results therapeutic use Time Factors timed function test Validity Walking Walking - physiology |
| title | The 6-minute walk test and other clinical endpoints in duchenne muscular dystrophy: Reliability, concurrent validity, and minimal clinically important differences from a multicenter study |
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