Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials
Identifieur interne : 004771 ( Main/Exploration ); précédent : 004770; suivant : 004772Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials
Auteurs : Lesley Ann Saketkoo [États-Unis] ; Shikha Mittoo [Canada] ; Dörte Huscher [Allemagne] ; Dinesh Khanna [États-Unis] ; Paul F. Dellaripa [États-Unis] ; Oliver Distler [Suisse] ; Kevin R. Flaherty [États-Unis] ; Sid Frankel [Canada] ; Chester V. Oddis [États-Unis] ; Christopher P. Denton [Royaume-Uni] ; Aryeh Fischer [États-Unis] ; Otylia M. Kowal-Bielecka [Pologne] ; Daphne Lesage [États-Unis] ; Peter A. Merkel [États-Unis] ; Kristine Phillips [États-Unis] ; David Pittrow [Allemagne] ; Jeffrey Swigris [États-Unis] ; Katerina Antoniou [Grèce] ; Robert P. Baughman [États-Unis] ; Flavia V. Castelino [États-Unis] ; Romy B. Christmann [États-Unis] ; Lisa Christopher-Stine [États-Unis] ; Harold R. Collard [États-Unis] ; Vincent Cottin [France] ; Sonye Danoff [États-Unis] ; Kristin B. Highland [États-Unis] ; Laura Hummers [États-Unis] ; Ami A. Shah [États-Unis] ; Dong Soon Kim [Corée du Sud] ; David A. Lynch [États-Unis] ; Frederick W. Miller [États-Unis] ; Susanna M. Proudman [Australie] ; Luca Richeldi ; Jay H. Ryu [États-Unis] ; Nora Sandorfi [États-Unis] ; Catherine Sarver [États-Unis] ; Athol U. Wells [Royaume-Uni] ; Vibeke Strand [États-Unis] ; Eric L. Matteson [États-Unis] ; Kevin K. Brown [États-Unis] ; James R. Seibold [États-Unis]Source :
- Thorax [ 0040-6376 ] ; 2013.
Abstract
Clinical trial design in interstitial lung diseases (ILDs) has been hampered by lack of consensus on appropriate outcome measures for reliably assessing treatment response. In the setting of connective tissue diseases (CTDs), some measures of ILD disease activity and severity may be confounded by non-pulmonary comorbidities.
The Connective Tissue Disease associated Interstitial Lung Disease (CTD-ILD) working group of Outcome Measures in Rheumatology—a non-profit international organisation dedicated to consensus methodology in identification of outcome measures—conducted a series of investigations which included a Delphi process including >248 ILD medical experts as well as patient focus groups culminating in a nominal group panel of ILD experts and patients. The goal was to define and develop a consensus on the status of outcome measure candidates for use in randomised controlled trials in CTD-ILD and idiopathic pulmonary fibrosis (IPF).
A core set comprising specific measures in the domains of lung physiology, lung imaging, survival, dyspnoea, cough and health-related quality of life is proposed as appropriate for consideration for use in a hypothetical 1-year multicentre clinical trial for either CTD-ILD or IPF. As many widely used instruments were found to lack full validation, an agenda for future research is proposed.
Identification of consensus preliminary domains and instruments to measure them was attained and is a major advance anticipated to facilitate multicentre RCTs in the field.
Url:
DOI: 10.1136/thoraxjnl-2013-204202
PubMed: 24368713
PubMed Central: 3995282
Affiliations:
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Highland</name><affiliation wicri:level="1"><nlm:aff id="af23"><institution>Cleveland Clinic</institution>,<addr-line>Cleveland, Ohio</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hummers, Laura" sort="Hummers, Laura" uniqKey="Hummers L" first="Laura" last="Hummers">Laura Hummers</name><affiliation wicri:level="1"><nlm:aff id="af20"><institution>Johns Hopkins University</institution>,<addr-line>Baltimore, Maryland</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Shah, Ami A" sort="Shah, Ami A" uniqKey="Shah A" first="Ami A" last="Shah">Ami A. Shah</name><affiliation wicri:level="1"><nlm:aff id="af20"><institution>Johns Hopkins University</institution>,<addr-line>Baltimore, Maryland</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kim, Dong Soon" sort="Kim, Dong Soon" uniqKey="Kim D" first="Dong Soon" last="Kim">Dong Soon Kim</name><affiliation wicri:level="1"><nlm:aff id="af24"><institution>Asan Medical Center University of Ulsan</institution>,<addr-line>Ulsan</addr-line>,<country>South Korea</country></nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Lynch, David A" sort="Lynch, David A" uniqKey="Lynch D" first="David A" last="Lynch">David A. 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Proudman</name><affiliation wicri:level="1"><nlm:aff id="af26"><institution>University of Adelaide</institution>,<addr-line>Adelaide</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Richeldi, Luca" sort="Richeldi, Luca" uniqKey="Richeldi L" first="Luca" last="Richeldi">Luca Richeldi</name><affiliation><nlm:aff id="af27"><institution>Respiratory Biomedical Research Unit, University of Southampton, UK</institution></nlm:aff></affiliation></author><author><name sortKey="Ryu, Jay H" sort="Ryu, Jay H" uniqKey="Ryu J" first="Jay H" last="Ryu">Jay H. Ryu</name><affiliation wicri:level="1"><nlm:aff id="af28"><institution>Mayo Clinic College of Medicine</institution>,<addr-line>Rochester, Minnesota</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Sandorfi, Nora" sort="Sandorfi, Nora" uniqKey="Sandorfi N" first="Nora" last="Sandorfi">Nora Sandorfi</name><affiliation wicri:level="1"><nlm:aff id="af14"><institution>University of Pennsylvania</institution>,<addr-line>Philadelphia, Pennsylvania</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Sarver, Catherine" sort="Sarver, Catherine" uniqKey="Sarver C" first="Catherine" last="Sarver">Catherine Sarver</name><affiliation wicri:level="1"><nlm:aff id="af29"><institution>Patient Research Partner</institution>,<addr-line>Maryland</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Wells, Athol U" sort="Wells, Athol U" uniqKey="Wells A" first="Athol U" last="Wells">Athol U. Wells</name><affiliation wicri:level="1"><nlm:aff id="af30"><institution>Royal Brompton Hospital and National Heart and Lung Institute</institution>,<addr-line>London</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Strand, Vibeke" sort="Strand, Vibeke" uniqKey="Strand V" first="Vibeke" last="Strand">Vibeke Strand</name><affiliation wicri:level="1"><nlm:aff id="af31"><institution>Stanford University</institution>,<addr-line>Palo Alto, California</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Matteson, Eric L" sort="Matteson, Eric L" uniqKey="Matteson E" first="Eric L" last="Matteson">Eric L. Matteson</name><affiliation wicri:level="1"><nlm:aff id="af28"><institution>Mayo Clinic College of Medicine</institution>,<addr-line>Rochester, Minnesota</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Brown, Kevin K" sort="Brown, Kevin K" uniqKey="Brown K" first="Kevin K" last="Brown">Kevin K. Brown</name><affiliation wicri:level="1"><nlm:aff id="af11"><institution>National Jewish Health</institution>,<addr-line>Denver, Colorado</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Seibold, James R" sort="Seibold, James R" uniqKey="Seibold J" first="James R" last="Seibold">James R. Seibold</name><affiliation wicri:level="1"><nlm:aff id="af32"><institution>Scleroderma Research Consultants, LLC</institution>,<addr-line>Avon, Connecticut</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24368713</idno><idno type="pmc">3995282</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3995282</idno><idno type="RBID">PMC:3995282</idno><idno type="doi">10.1136/thoraxjnl-2013-204202</idno><date when="2013">2013</date><idno type="wicri:Area/Pmc/Corpus">002D31</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002D31</idno><idno type="wicri:Area/Pmc/Curation">002B81</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">002B81</idno><idno type="wicri:Area/Pmc/Checkpoint">001B93</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">001B93</idno><idno type="wicri:Area/Ncbi/Merge">001680</idno><idno type="wicri:Area/Ncbi/Curation">001680</idno><idno type="wicri:Area/Ncbi/Checkpoint">001680</idno><idno type="wicri:doubleKey">0040-6376:2013:Saketkoo L:connective:tissue:disease</idno><idno type="wicri:Area/Main/Merge">004887</idno><idno type="wicri:Area/Main/Curation">004771</idno><idno type="wicri:Area/Main/Exploration">004771</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials</title><author><name sortKey="Saketkoo, Lesley Ann" sort="Saketkoo, Lesley Ann" uniqKey="Saketkoo L" first="Lesley Ann" last="Saketkoo">Lesley Ann Saketkoo</name><affiliation wicri:level="1"><nlm:aff id="af1"><institution>Louisiana State University Health Sciences Center</institution>,<addr-line>New Orleans, Louisiana</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Mittoo, Shikha" sort="Mittoo, Shikha" uniqKey="Mittoo S" first="Shikha" last="Mittoo">Shikha Mittoo</name><affiliation wicri:level="1"><nlm:aff id="af2"><institution>University of Toronto</institution>,<addr-line>Toronto</addr-line>,<country>Canada</country></nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Huscher, Dorte" sort="Huscher, Dorte" uniqKey="Huscher D" first="Dörte" last="Huscher">Dörte Huscher</name><affiliation wicri:level="1"><nlm:aff id="af3"><institution>German Rheumatism Research Centre</institution>,<addr-line>Berlin</addr-line>,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="af4"><institution>Charité Universitaetsmedizin</institution>,<addr-line>Berlin</addr-line>,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Khanna, Dinesh" sort="Khanna, Dinesh" uniqKey="Khanna D" first="Dinesh" last="Khanna">Dinesh Khanna</name><affiliation wicri:level="1"><nlm:aff id="af5"><institution>University of Michigan</institution>,<addr-line>Ann Arbor, Michigan</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Dellaripa, Paul F" sort="Dellaripa, Paul F" uniqKey="Dellaripa P" first="Paul F" last="Dellaripa">Paul F. Dellaripa</name><affiliation wicri:level="1"><nlm:aff id="af6"><institution>Brigham and Womens Hospital</institution>,<addr-line>Boston, Massachusetts</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Distler, Oliver" sort="Distler, Oliver" uniqKey="Distler O" first="Oliver" last="Distler">Oliver Distler</name><affiliation wicri:level="1"><nlm:aff id="af7"><institution>University Hospital Zurich</institution>,<addr-line>Zurich</addr-line>,<country>Switzerland</country></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Flaherty, Kevin R" sort="Flaherty, Kevin R" uniqKey="Flaherty K" first="Kevin R" last="Flaherty">Kevin R. Flaherty</name><affiliation wicri:level="1"><nlm:aff id="af5"><institution>University of Michigan</institution>,<addr-line>Ann Arbor, Michigan</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Frankel, Sid" sort="Frankel, Sid" uniqKey="Frankel S" first="Sid" last="Frankel">Sid Frankel</name><affiliation wicri:level="1"><nlm:aff id="af8"><institution>University of Manitoba</institution>,<addr-line>Manitoba</addr-line>,<country>Canada</country></nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Oddis, Chester V" sort="Oddis, Chester V" uniqKey="Oddis C" first="Chester V" last="Oddis">Chester V. Oddis</name><affiliation wicri:level="1"><nlm:aff id="af9"><institution>University of Pittsburgh</institution>,<addr-line>Pittsburgh, Pennsylvania</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Denton, Christopher P" sort="Denton, Christopher P" uniqKey="Denton C" first="Christopher P" last="Denton">Christopher P. Denton</name><affiliation wicri:level="1"><nlm:aff id="af10"><institution>Royal Free Hospital</institution>,<addr-line>London</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Fischer, Aryeh" sort="Fischer, Aryeh" uniqKey="Fischer A" first="Aryeh" last="Fischer">Aryeh Fischer</name><affiliation wicri:level="1"><nlm:aff id="af11"><institution>National Jewish Health</institution>,<addr-line>Denver, Colorado</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kowal Bielecka, Otylia M" sort="Kowal Bielecka, Otylia M" uniqKey="Kowal Bielecka O" first="Otylia M" last="Kowal-Bielecka">Otylia M. Kowal-Bielecka</name><affiliation wicri:level="1"><nlm:aff id="af12"><institution>Medical University of Bialystok</institution>,<addr-line>Bialystok</addr-line>,<country>Poland</country></nlm:aff><country xml:lang="fr">Pologne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Lesage, Daphne" sort="Lesage, Daphne" uniqKey="Lesage D" first="Daphne" last="Lesage">Daphne Lesage</name><affiliation wicri:level="1"><nlm:aff id="af13"><institution>Patient Research Partner, Office of Public Health</institution>,<addr-line>New Orleans, Louisiana</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Merkel, Peter A" sort="Merkel, Peter A" uniqKey="Merkel P" first="Peter A" last="Merkel">Peter A. Merkel</name><affiliation wicri:level="1"><nlm:aff id="af14"><institution>University of Pennsylvania</institution>,<addr-line>Philadelphia, Pennsylvania</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Phillips, Kristine" sort="Phillips, Kristine" uniqKey="Phillips K" first="Kristine" last="Phillips">Kristine Phillips</name><affiliation wicri:level="1"><nlm:aff id="af5"><institution>University of Michigan</institution>,<addr-line>Ann Arbor, Michigan</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Pittrow, David" sort="Pittrow, David" uniqKey="Pittrow D" first="David" last="Pittrow">David Pittrow</name><affiliation wicri:level="1"><nlm:aff id="af15"><institution>University of Dresden</institution>,<addr-line>Dresden</addr-line>,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Swigris, Jeffrey" sort="Swigris, Jeffrey" uniqKey="Swigris J" first="Jeffrey" last="Swigris">Jeffrey Swigris</name><affiliation wicri:level="1"><nlm:aff id="af11"><institution>National Jewish Health</institution>,<addr-line>Denver, Colorado</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Antoniou, Katerina" sort="Antoniou, Katerina" uniqKey="Antoniou K" first="Katerina" last="Antoniou">Katerina Antoniou</name><affiliation wicri:level="1"><nlm:aff id="af16"><institution>University of Crete</institution>,<addr-line>Heraklion</addr-line>,<country>Greece</country></nlm:aff><country xml:lang="fr">Grèce</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Baughman, Robert P" sort="Baughman, Robert P" uniqKey="Baughman R" first="Robert P" last="Baughman">Robert P. Baughman</name><affiliation wicri:level="1"><nlm:aff id="af17"><institution>University of Cincinnati</institution>,<addr-line>Cincinnati, Ohio</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Castelino, Flavia V" sort="Castelino, Flavia V" uniqKey="Castelino F" first="Flavia V" last="Castelino">Flavia V. Castelino</name><affiliation wicri:level="1"><nlm:aff id="af18"><institution>Massachusetts General Hospital</institution>,<addr-line>Boston, Massachusetts</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Christmann, Romy B" sort="Christmann, Romy B" uniqKey="Christmann R" first="Romy B" last="Christmann">Romy B. Christmann</name><affiliation wicri:level="1"><nlm:aff id="af19"><institution>Boston University School of Medicine</institution>,<addr-line>Boston, Massachusetts</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Christopher Stine, Lisa" sort="Christopher Stine, Lisa" uniqKey="Christopher Stine L" first="Lisa" last="Christopher-Stine">Lisa Christopher-Stine</name><affiliation wicri:level="1"><nlm:aff id="af20"><institution>Johns Hopkins University</institution>,<addr-line>Baltimore, Maryland</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Collard, Harold R" sort="Collard, Harold R" uniqKey="Collard H" first="Harold R" last="Collard">Harold R. Collard</name><affiliation wicri:level="1"><nlm:aff id="af21"><institution>University of California-San Francisco</institution>,<addr-line>San Francisco, California</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Cottin, Vincent" sort="Cottin, Vincent" uniqKey="Cottin V" first="Vincent" last="Cottin">Vincent Cottin</name><affiliation wicri:level="1"><nlm:aff id="af22"><institution>Claude Bernard University</institution>,<addr-line>Lyon</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Danoff, Sonye" sort="Danoff, Sonye" uniqKey="Danoff S" first="Sonye" last="Danoff">Sonye Danoff</name><affiliation wicri:level="1"><nlm:aff id="af20"><institution>Johns Hopkins University</institution>,<addr-line>Baltimore, Maryland</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Highland, Kristin B" sort="Highland, Kristin B" uniqKey="Highland K" first="Kristin B" last="Highland">Kristin B. Highland</name><affiliation wicri:level="1"><nlm:aff id="af23"><institution>Cleveland Clinic</institution>,<addr-line>Cleveland, Ohio</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hummers, Laura" sort="Hummers, Laura" uniqKey="Hummers L" first="Laura" last="Hummers">Laura Hummers</name><affiliation wicri:level="1"><nlm:aff id="af20"><institution>Johns Hopkins University</institution>,<addr-line>Baltimore, Maryland</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Shah, Ami A" sort="Shah, Ami A" uniqKey="Shah A" first="Ami A" last="Shah">Ami A. Shah</name><affiliation wicri:level="1"><nlm:aff id="af20"><institution>Johns Hopkins University</institution>,<addr-line>Baltimore, Maryland</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kim, Dong Soon" sort="Kim, Dong Soon" uniqKey="Kim D" first="Dong Soon" last="Kim">Dong Soon Kim</name><affiliation wicri:level="1"><nlm:aff id="af24"><institution>Asan Medical Center University of Ulsan</institution>,<addr-line>Ulsan</addr-line>,<country>South Korea</country></nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Lynch, David A" sort="Lynch, David A" uniqKey="Lynch D" first="David A" last="Lynch">David A. Lynch</name><affiliation wicri:level="1"><nlm:aff id="af11"><institution>National Jewish Health</institution>,<addr-line>Denver, Colorado</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Miller, Frederick W" sort="Miller, Frederick W" uniqKey="Miller F" first="Frederick W" last="Miller">Frederick W. Miller</name><affiliation wicri:level="1"><nlm:aff id="af25"><institution>National Institute of Environmental Health Sciences, National Institutes of Health</institution>,<addr-line>Bethesda, Maryland</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Proudman, Susanna M" sort="Proudman, Susanna M" uniqKey="Proudman S" first="Susanna M" last="Proudman">Susanna M. Proudman</name><affiliation wicri:level="1"><nlm:aff id="af26"><institution>University of Adelaide</institution>,<addr-line>Adelaide</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Richeldi, Luca" sort="Richeldi, Luca" uniqKey="Richeldi L" first="Luca" last="Richeldi">Luca Richeldi</name><affiliation><nlm:aff id="af27"><institution>Respiratory Biomedical Research Unit, University of Southampton, UK</institution></nlm:aff></affiliation></author><author><name sortKey="Ryu, Jay H" sort="Ryu, Jay H" uniqKey="Ryu J" first="Jay H" last="Ryu">Jay H. Ryu</name><affiliation wicri:level="1"><nlm:aff id="af28"><institution>Mayo Clinic College of Medicine</institution>,<addr-line>Rochester, Minnesota</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Sandorfi, Nora" sort="Sandorfi, Nora" uniqKey="Sandorfi N" first="Nora" last="Sandorfi">Nora Sandorfi</name><affiliation wicri:level="1"><nlm:aff id="af14"><institution>University of Pennsylvania</institution>,<addr-line>Philadelphia, Pennsylvania</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Sarver, Catherine" sort="Sarver, Catherine" uniqKey="Sarver C" first="Catherine" last="Sarver">Catherine Sarver</name><affiliation wicri:level="1"><nlm:aff id="af29"><institution>Patient Research Partner</institution>,<addr-line>Maryland</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Wells, Athol U" sort="Wells, Athol U" uniqKey="Wells A" first="Athol U" last="Wells">Athol U. Wells</name><affiliation wicri:level="1"><nlm:aff id="af30"><institution>Royal Brompton Hospital and National Heart and Lung Institute</institution>,<addr-line>London</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Strand, Vibeke" sort="Strand, Vibeke" uniqKey="Strand V" first="Vibeke" last="Strand">Vibeke Strand</name><affiliation wicri:level="1"><nlm:aff id="af31"><institution>Stanford University</institution>,<addr-line>Palo Alto, California</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Matteson, Eric L" sort="Matteson, Eric L" uniqKey="Matteson E" first="Eric L" last="Matteson">Eric L. Matteson</name><affiliation wicri:level="1"><nlm:aff id="af28"><institution>Mayo Clinic College of Medicine</institution>,<addr-line>Rochester, Minnesota</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Brown, Kevin K" sort="Brown, Kevin K" uniqKey="Brown K" first="Kevin K" last="Brown">Kevin K. Brown</name><affiliation wicri:level="1"><nlm:aff id="af11"><institution>National Jewish Health</institution>,<addr-line>Denver, Colorado</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Seibold, James R" sort="Seibold, James R" uniqKey="Seibold J" first="James R" last="Seibold">James R. Seibold</name><affiliation wicri:level="1"><nlm:aff id="af32"><institution>Scleroderma Research Consultants, LLC</institution>,<addr-line>Avon, Connecticut</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">Thorax</title><idno type="ISSN">0040-6376</idno><idno type="eISSN">1468-3296</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Rationale</title><p>Clinical trial design in interstitial lung diseases (ILDs) has been hampered by lack of consensus on appropriate outcome measures for reliably assessing treatment response. In the setting of connective tissue diseases (CTDs), some measures of ILD disease activity and severity may be confounded by non-pulmonary comorbidities.</p></sec><sec><title>Methods</title><p>The Connective Tissue Disease associated Interstitial Lung Disease (CTD-ILD) working group of Outcome Measures in Rheumatology—a non-profit international organisation dedicated to consensus methodology in identification of outcome measures—conducted a series of investigations which included a Delphi process including >248 ILD medical experts as well as patient focus groups culminating in a nominal group panel of ILD experts and patients. The goal was to define and develop a consensus on the status of outcome measure candidates for use in randomised controlled trials in CTD-ILD and idiopathic pulmonary fibrosis (IPF).</p></sec><sec><title>Results</title><p>A core set comprising specific measures in the domains of lung physiology, lung imaging, survival, dyspnoea, cough and health-related quality of life is proposed as appropriate for consideration for use in a hypothetical 1-year multicentre clinical trial for either CTD-ILD or IPF. As many widely used instruments were found to lack full validation, an agenda for future research is proposed.</p></sec><sec><title>Conclusion</title><p>Identification of consensus preliminary domains and instruments to measure them was attained and is a major advance anticipated to facilitate multicentre RCTs in the field.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Raghu, G" uniqKey="Raghu G">G Raghu</name></author><author><name sortKey="Collard, Hr" uniqKey="Collard H">HR Collard</name></author><author><name sortKey="Egan, Jj" uniqKey="Egan J">JJ Egan</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Tyndall, Aj" uniqKey="Tyndall A">AJ Tyndall</name></author><author><name sortKey="Bannert, B" uniqKey="Bannert B">B Bannert</name></author><author><name sortKey="Vonk, M" uniqKey="Vonk M">M 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Seibold</name></author><author><name sortKey="Denton, C" uniqKey="Denton C">C Denton</name></author><author><name sortKey="Furst, De" uniqKey="Furst D">DE Furst</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Corte, Tj" uniqKey="Corte T">TJ Corte</name></author><author><name sortKey="Goh, Ns" uniqKey="Goh N">NS Goh</name></author><author><name sortKey="Glaspole, In" uniqKey="Glaspole I">IN Glaspole</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ryerson, Cj" uniqKey="Ryerson C">CJ Ryerson</name></author><author><name sortKey="Abbritti, M" uniqKey="Abbritti M">M Abbritti</name></author><author><name sortKey="Ley, B" uniqKey="Ley B">B Ley</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Theodore, Ac" uniqKey="Theodore A">AC Theodore</name></author><author><name sortKey="Tseng, Ch" uniqKey="Tseng C">CH Tseng</name></author><author><name sortKey="Li, N" uniqKey="Li N">N Li</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Key, Al" uniqKey="Key A">AL Key</name></author><author><name sortKey="Holt, K" uniqKey="Holt K">K Holt</name></author><author><name sortKey="Hamilton, A" uniqKey="Hamilton A">A Hamilton</name></author></analytic></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Canada</li><li>Corée du Sud</li><li>France</li><li>Grèce</li><li>Pologne</li><li>Royaume-Uni</li><li>Suisse</li><li>États-Unis</li></country></list><tree><noCountry><name sortKey="Richeldi, Luca" sort="Richeldi, Luca" uniqKey="Richeldi L" first="Luca" last="Richeldi">Luca Richeldi</name></noCountry><country name="États-Unis"><noRegion><name sortKey="Saketkoo, Lesley Ann" sort="Saketkoo, Lesley Ann" uniqKey="Saketkoo L" first="Lesley Ann" last="Saketkoo">Lesley Ann Saketkoo</name></noRegion><name sortKey="Baughman, Robert P" sort="Baughman, Robert P" uniqKey="Baughman R" first="Robert P" last="Baughman">Robert P. Baughman</name><name sortKey="Brown, Kevin K" sort="Brown, Kevin K" uniqKey="Brown K" first="Kevin K" last="Brown">Kevin K. Brown</name><name sortKey="Castelino, Flavia V" sort="Castelino, Flavia V" uniqKey="Castelino F" first="Flavia V" last="Castelino">Flavia V. Castelino</name><name sortKey="Christmann, Romy B" sort="Christmann, Romy B" uniqKey="Christmann R" first="Romy B" last="Christmann">Romy B. Christmann</name><name sortKey="Christopher Stine, Lisa" sort="Christopher Stine, Lisa" uniqKey="Christopher Stine L" first="Lisa" last="Christopher-Stine">Lisa Christopher-Stine</name><name sortKey="Collard, Harold R" sort="Collard, Harold R" uniqKey="Collard H" first="Harold R" last="Collard">Harold R. Collard</name><name sortKey="Danoff, Sonye" sort="Danoff, Sonye" uniqKey="Danoff S" first="Sonye" last="Danoff">Sonye Danoff</name><name sortKey="Dellaripa, Paul F" sort="Dellaripa, Paul F" uniqKey="Dellaripa P" first="Paul F" last="Dellaripa">Paul F. Dellaripa</name><name sortKey="Fischer, Aryeh" sort="Fischer, Aryeh" uniqKey="Fischer A" first="Aryeh" last="Fischer">Aryeh Fischer</name><name sortKey="Flaherty, Kevin R" sort="Flaherty, Kevin R" uniqKey="Flaherty K" first="Kevin R" last="Flaherty">Kevin R. Flaherty</name><name sortKey="Highland, Kristin B" sort="Highland, Kristin B" uniqKey="Highland K" first="Kristin B" last="Highland">Kristin B. Highland</name><name sortKey="Hummers, Laura" sort="Hummers, Laura" uniqKey="Hummers L" first="Laura" last="Hummers">Laura Hummers</name><name sortKey="Khanna, Dinesh" sort="Khanna, Dinesh" uniqKey="Khanna D" first="Dinesh" last="Khanna">Dinesh Khanna</name><name sortKey="Lesage, Daphne" sort="Lesage, Daphne" uniqKey="Lesage D" first="Daphne" last="Lesage">Daphne Lesage</name><name sortKey="Lynch, David A" sort="Lynch, David A" uniqKey="Lynch D" first="David A" last="Lynch">David A. Lynch</name><name sortKey="Matteson, Eric L" sort="Matteson, Eric L" uniqKey="Matteson E" first="Eric L" last="Matteson">Eric L. Matteson</name><name sortKey="Merkel, Peter A" sort="Merkel, Peter A" uniqKey="Merkel P" first="Peter A" last="Merkel">Peter A. Merkel</name><name sortKey="Miller, Frederick W" sort="Miller, Frederick W" uniqKey="Miller F" first="Frederick W" last="Miller">Frederick W. Miller</name><name sortKey="Oddis, Chester V" sort="Oddis, Chester V" uniqKey="Oddis C" first="Chester V" last="Oddis">Chester V. Oddis</name><name sortKey="Phillips, Kristine" sort="Phillips, Kristine" uniqKey="Phillips K" first="Kristine" last="Phillips">Kristine Phillips</name><name sortKey="Ryu, Jay H" sort="Ryu, Jay H" uniqKey="Ryu J" first="Jay H" last="Ryu">Jay H. Ryu</name><name sortKey="Sandorfi, Nora" sort="Sandorfi, Nora" uniqKey="Sandorfi N" first="Nora" last="Sandorfi">Nora Sandorfi</name><name sortKey="Sarver, Catherine" sort="Sarver, Catherine" uniqKey="Sarver C" first="Catherine" last="Sarver">Catherine Sarver</name><name sortKey="Seibold, James R" sort="Seibold, James R" uniqKey="Seibold J" first="James R" last="Seibold">James R. Seibold</name><name sortKey="Shah, Ami A" sort="Shah, Ami A" uniqKey="Shah A" first="Ami A" last="Shah">Ami A. Shah</name><name sortKey="Strand, Vibeke" sort="Strand, Vibeke" uniqKey="Strand V" first="Vibeke" last="Strand">Vibeke Strand</name><name sortKey="Swigris, Jeffrey" sort="Swigris, Jeffrey" uniqKey="Swigris J" first="Jeffrey" last="Swigris">Jeffrey Swigris</name></country><country name="Canada"><noRegion><name sortKey="Mittoo, Shikha" sort="Mittoo, Shikha" uniqKey="Mittoo S" first="Shikha" last="Mittoo">Shikha Mittoo</name></noRegion><name sortKey="Frankel, Sid" sort="Frankel, Sid" uniqKey="Frankel S" first="Sid" last="Frankel">Sid Frankel</name></country><country name="Allemagne"><noRegion><name sortKey="Huscher, Dorte" sort="Huscher, Dorte" uniqKey="Huscher D" first="Dörte" last="Huscher">Dörte Huscher</name></noRegion><name sortKey="Huscher, Dorte" sort="Huscher, Dorte" uniqKey="Huscher D" first="Dörte" last="Huscher">Dörte Huscher</name><name sortKey="Pittrow, David" sort="Pittrow, David" uniqKey="Pittrow D" first="David" last="Pittrow">David Pittrow</name></country><country name="Suisse"><noRegion><name sortKey="Distler, Oliver" sort="Distler, Oliver" uniqKey="Distler O" first="Oliver" last="Distler">Oliver Distler</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Denton, Christopher P" sort="Denton, Christopher P" uniqKey="Denton C" first="Christopher P" last="Denton">Christopher P. Denton</name></noRegion><name sortKey="Wells, Athol U" sort="Wells, Athol U" uniqKey="Wells A" first="Athol U" last="Wells">Athol U. Wells</name></country><country name="Pologne"><noRegion><name sortKey="Kowal Bielecka, Otylia M" sort="Kowal Bielecka, Otylia M" uniqKey="Kowal Bielecka O" first="Otylia M" last="Kowal-Bielecka">Otylia M. Kowal-Bielecka</name></noRegion></country><country name="Grèce"><noRegion><name sortKey="Antoniou, Katerina" sort="Antoniou, Katerina" uniqKey="Antoniou K" first="Katerina" last="Antoniou">Katerina Antoniou</name></noRegion></country><country name="France"><noRegion><name sortKey="Cottin, Vincent" sort="Cottin, Vincent" uniqKey="Cottin V" first="Vincent" last="Cottin">Vincent Cottin</name></noRegion></country><country name="Corée du Sud"><noRegion><name sortKey="Kim, Dong Soon" sort="Kim, Dong Soon" uniqKey="Kim D" first="Dong Soon" last="Kim">Dong Soon Kim</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Proudman, Susanna M" sort="Proudman, Susanna M" uniqKey="Proudman S" first="Susanna M" last="Proudman">Susanna M. Proudman</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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