The American College of Rheumatology provisional composite response index for clinical trials in early diffuse cutaneous systemic sclerosis
Identifieur interne : 000576 ( Pmc/Checkpoint ); précédent : 000575; suivant : 000577The American College of Rheumatology provisional composite response index for clinical trials in early diffuse cutaneous systemic sclerosis
Auteurs : Dinesh Khanna [États-Unis] ; Veronica J. Berrocal [États-Unis] ; Edward H. Giannini [États-Unis] ; James R. Seibold [États-Unis] ; Peter A. Merkel [États-Unis] ; Maureen D. Mayes [États-Unis] ; Murray Baron [Canada] ; Philip J. Clements [États-Unis] ; Virginia Steen [États-Unis] ; Shervin Assassi [États-Unis] ; Elena Schiopu [États-Unis] ; Kristine Phillips [États-Unis] ; Robert W. Simms [États-Unis] ; Yannick Allanore [France] ; Christopher P. Denton [Royaume-Uni] ; Oliver Distler [Suisse] ; Sindhu R. Johnson [Canada] ; Marco Matucci-Cerinic [Italie] ; Janet Pope ; Susanna M. Proudman [Australie] ; Jeffrey Siegel [États-Unis] ; Weng Kee Wong [États-Unis] ; Athol U. Wells [Royaume-Uni] ; Daniel E. Furst [États-Unis]Source :
- Arthritis & rheumatology (Hoboken, N.J.) [ 2326-5191 ] ; 2016.
Abstract
Early diffuse cutaneous systemic sclerosis (dcSSc) is characterized by rapid changes of skin and internal organs. Our objective was to develop a composite response index in dcSSc (abbreviated CRISS) for use in randomized controlled trial (RCT.
We developed 150 paper patient profiles with standardized clinical outcome elements (core set items) using patients with dcSSc. Forty scleroderma experts rated 20 patient profiles each and assessed whether each patient had improved or not over a period of 1 year. Using profiles where raters reached a consensus on whether the patients were improved vs. not (79% of profiles examined), we fit logistic regression models where the binary outcome referred to whether the patient was improved or not, and the change in the core set items from baseline to follow-up were entered as covariates. We tested the final index in a previously completed RCT.
Sixteen of 31 core items were included in the patient profiles after a consensus meeting and review of test characteristics of patient-level data. The logistic regression model that included the following core set items: changes in the Rodnan skin score, forced vital capacity (FVC)% predicted, patient and physician global assessments, and HAQ-DI over 1 year had sensitivity of 0.982 (95%CI: 0.981-0.983), specificity of 0.931 (95% CI: 0.930-0.932), and had the highest face validity. Subjects with a significant decline in renal or cardiopulmonary involvement were classified as not improved, regardless of improvements in other core items. The index was able to differentiate the effect of methotrexate from placebo in a 1-year RCT (p< 0.05).
We have developed CRISS that is appropriate for use as an outcome assessment in RCT of early dcSSc.
Url:
DOI: 10.1002/art.39501
PubMed: 26808827
PubMed Central: 4826472
Affiliations:
- Australie, Canada, France, Italie, Royaume-Uni, Suisse, États-Unis
- Angleterre, Californie, Connecticut, District de Columbia, Grand Londres, Massachusetts, Michigan, Ohio, Ontario, Pennsylvanie, Québec, Texas, Île-de-France
- Londres, Montréal, Paris, Toronto
- Université McGill, Université de Toronto
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PMC:4826472Le document en format XML
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<author><name sortKey="Assassi, Shervin" sort="Assassi, Shervin" uniqKey="Assassi S" first="Shervin" last="Assassi">Shervin Assassi</name>
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<author><name sortKey="Schiopu, Elena" sort="Schiopu, Elena" uniqKey="Schiopu E" first="Elena" last="Schiopu">Elena Schiopu</name>
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<author><name sortKey="Simms, Robert W" sort="Simms, Robert W" uniqKey="Simms R" first="Robert W." last="Simms">Robert W. Simms</name>
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<author><name sortKey="Denton, Christopher P" sort="Denton, Christopher P" uniqKey="Denton C" first="Christopher P." last="Denton">Christopher P. Denton</name>
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<author><name sortKey="Johnson, Sindhu R" sort="Johnson, Sindhu R" uniqKey="Johnson S" first="Sindhu R." last="Johnson">Sindhu R. Johnson</name>
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<author><name sortKey="Furst, Daniel E" sort="Furst, Daniel E" uniqKey="Furst D" first="Daniel E." last="Furst">Daniel E. Furst</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">The American College of Rheumatology provisional composite response index for clinical trials in early diffuse cutaneous systemic sclerosis</title>
<author><name sortKey="Khanna, Dinesh" sort="Khanna, Dinesh" uniqKey="Khanna D" first="Dinesh" last="Khanna">Dinesh Khanna</name>
<affiliation wicri:level="2"><nlm:aff id="A1">University of Michigan Scleroderma Program, Ann Arbor, MI, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Michigan Scleroderma Program, Ann Arbor, MI</wicri:regionArea>
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<author><name sortKey="Berrocal, Veronica J" sort="Berrocal, Veronica J" uniqKey="Berrocal V" first="Veronica J." last="Berrocal">Veronica J. Berrocal</name>
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<author><name sortKey="Giannini, Edward H" sort="Giannini, Edward H" uniqKey="Giannini E" first="Edward H." last="Giannini">Edward H. Giannini</name>
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<author><name sortKey="Seibold, James R" sort="Seibold, James R" uniqKey="Seibold J" first="James R." last="Seibold">James R. Seibold</name>
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<author><name sortKey="Merkel, Peter A" sort="Merkel, Peter A" uniqKey="Merkel P" first="Peter A." last="Merkel">Peter A. Merkel</name>
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<author><name sortKey="Mayes, Maureen D" sort="Mayes, Maureen D" uniqKey="Mayes M" first="Maureen D." last="Mayes">Maureen D. Mayes</name>
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<author><name sortKey="Baron, Murray" sort="Baron, Murray" uniqKey="Baron M" first="Murray" last="Baron">Murray Baron</name>
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<author><name sortKey="Clements, Philip J" sort="Clements, Philip J" uniqKey="Clements P" first="Philip J." last="Clements">Philip J. Clements</name>
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<author><name sortKey="Steen, Virginia" sort="Steen, Virginia" uniqKey="Steen V" first="Virginia" last="Steen">Virginia Steen</name>
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<author><name sortKey="Assassi, Shervin" sort="Assassi, Shervin" uniqKey="Assassi S" first="Shervin" last="Assassi">Shervin Assassi</name>
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<author><name sortKey="Schiopu, Elena" sort="Schiopu, Elena" uniqKey="Schiopu E" first="Elena" last="Schiopu">Elena Schiopu</name>
<affiliation wicri:level="2"><nlm:aff id="A1">University of Michigan Scleroderma Program, Ann Arbor, MI, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Michigan Scleroderma Program, Ann Arbor, MI</wicri:regionArea>
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<author><name sortKey="Phillips, Kristine" sort="Phillips, Kristine" uniqKey="Phillips K" first="Kristine" last="Phillips">Kristine Phillips</name>
<affiliation wicri:level="2"><nlm:aff id="A1">University of Michigan Scleroderma Program, Ann Arbor, MI, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
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<author><name sortKey="Simms, Robert W" sort="Simms, Robert W" uniqKey="Simms R" first="Robert W." last="Simms">Robert W. Simms</name>
<affiliation wicri:level="2"><nlm:aff id="A10">Boston University, Boston, MA, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Boston University, Boston, MA</wicri:regionArea>
<placeName><region type="state">Massachusetts</region>
</placeName>
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<author><name sortKey="Allanore, Yannick" sort="Allanore, Yannick" uniqKey="Allanore Y" first="Yannick" last="Allanore">Yannick Allanore</name>
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<country xml:lang="fr">France</country>
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<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="3"><nlm:aff id="A12">Centre for Rheumatology, Royal Free and University College London Medical School, London, UK</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Centre for Rheumatology, Royal Free and University College London Medical School, London</wicri:regionArea>
<placeName><settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
</placeName>
</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="A13">Division of Rheumatology, University Hospital Zurich, Zurich, Switzerland</nlm:aff>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Division of Rheumatology, University Hospital Zurich, Zurich</wicri:regionArea>
<wicri:noRegion>Zurich</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Johnson, Sindhu R" sort="Johnson, Sindhu R" uniqKey="Johnson S" first="Sindhu R." last="Johnson">Sindhu R. Johnson</name>
<affiliation wicri:level="4"><nlm:aff id="A14">Toronto Scleroderma Program, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Toronto Scleroderma Program, Toronto Western Hospital, University of Toronto, Toronto, Ontario</wicri:regionArea>
<orgName type="university">Université de Toronto</orgName>
<placeName><settlement type="city">Toronto</settlement>
<region type="state">Ontario</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Matucci Cerinic, Marco" sort="Matucci Cerinic, Marco" uniqKey="Matucci Cerinic M" first="Marco" last="Matucci-Cerinic">Marco Matucci-Cerinic</name>
<affiliation wicri:level="1"><nlm:aff id="A15"> Department of Experimental & Clinical Medicine, Division of Rheumatology AOUC, University of Florence, Firenze, Italy</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea> Department of Experimental & Clinical Medicine, Division of Rheumatology AOUC, University of Florence, Firenze</wicri:regionArea>
<wicri:noRegion>Firenze</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Pope, Janet" sort="Pope, Janet" uniqKey="Pope J" first="Janet" last="Pope">Janet Pope</name>
<affiliation><nlm:aff id="A16">Schulich School of Medicine, Western University, London and St Joseph's Health Care, London, ON</nlm:aff>
<wicri:noCountry code="subfield">ON</wicri:noCountry>
</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="A17">Royal Adelaide Hospital, North Terrace and Discipline of Medicine, University of Adelaide, Adelaide, SA, Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Royal Adelaide Hospital, North Terrace and Discipline of Medicine, University of Adelaide, Adelaide, SA</wicri:regionArea>
<wicri:noRegion>SA</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Siegel, Jeffrey" sort="Siegel, Jeffrey" uniqKey="Siegel J" first="Jeffrey" last="Siegel">Jeffrey Siegel</name>
<affiliation wicri:level="2"><nlm:aff id="A18">Genentech/Roche, San Francisco, CA, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Genentech/Roche, San Francisco, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Wong, Weng Kee" sort="Wong, Weng Kee" uniqKey="Wong W" first="Weng Kee" last="Wong">Weng Kee Wong</name>
<affiliation wicri:level="2"><nlm:aff id="A8">UCLA, Los Angeles, CA, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>UCLA, Los Angeles, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</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="3"><nlm:aff id="A19">Royal Brompton Hospital, London, UK</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Royal Brompton Hospital, London</wicri:regionArea>
<placeName><settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Furst, Daniel E" sort="Furst, Daniel E" uniqKey="Furst D" first="Daniel E." last="Furst">Daniel E. Furst</name>
<affiliation wicri:level="2"><nlm:aff id="A8">UCLA, Los Angeles, CA, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>UCLA, Los Angeles, CA</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">Arthritis & rheumatology (Hoboken, N.J.)</title>
<idno type="ISSN">2326-5191</idno>
<idno type="eISSN">2326-5205</idno>
<imprint><date when="2016">2016</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec id="S1"><title>Introduction</title>
<p id="P1">Early diffuse cutaneous systemic sclerosis (dcSSc) is characterized by rapid changes of skin and internal organs. Our objective was to develop a composite response index in dcSSc (abbreviated CRISS) for use in randomized controlled trial (RCT.</p>
</sec>
<sec id="S2"><title>Methods</title>
<p id="P2">We developed 150 paper patient profiles with standardized clinical outcome elements (core set items) using patients with dcSSc. Forty scleroderma experts rated 20 patient profiles each and assessed whether each patient had improved or not over a period of 1 year. Using profiles where raters reached a consensus on whether the patients were improved vs. not (79% of profiles examined), we fit logistic regression models where the binary outcome referred to whether the patient was improved or not, and the change in the core set items from baseline to follow-up were entered as covariates. We tested the final index in a previously completed RCT.</p>
</sec>
<sec id="S3"><title>Results</title>
<p id="P3">Sixteen of 31 core items were included in the patient profiles after a consensus meeting and review of test characteristics of patient-level data. The logistic regression model that included the following core set items: changes in the Rodnan skin score, forced vital capacity (FVC)% predicted, patient and physician global assessments, and HAQ-DI over 1 year had sensitivity of 0.982 (95%CI: 0.981-0.983), specificity of 0.931 (95% CI: 0.930-0.932), and had the highest face validity. Subjects with a significant decline in renal or cardiopulmonary involvement were classified as not improved, regardless of improvements in other core items. The index was able to differentiate the effect of methotrexate from placebo in a 1-year RCT (p< 0.05).</p>
</sec>
<sec id="S4"><title>Conclusion</title>
<p id="P4">We have developed CRISS that is appropriate for use as an outcome assessment in RCT of early dcSSc.</p>
</sec>
</div>
</front>
</TEI>
<pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">101623795</journal-id>
<journal-id journal-id-type="pubmed-jr-id">42112</journal-id>
<journal-id journal-id-type="nlm-ta">Arthritis Rheumatol</journal-id>
<journal-title-group><journal-title>Arthritis & rheumatology (Hoboken, N.J.)</journal-title>
</journal-title-group>
<issn pub-type="ppub">2326-5191</issn>
<issn pub-type="epub">2326-5205</issn>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">26808827</article-id>
<article-id pub-id-type="pmc">4826472</article-id>
<article-id pub-id-type="doi">10.1002/art.39501</article-id>
<article-id pub-id-type="manuscript">NIHMS771266</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Article</subject>
</subj-group>
</article-categories>
<title-group><article-title>The American College of Rheumatology provisional composite response index for clinical trials in early diffuse cutaneous systemic sclerosis</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Khanna</surname>
<given-names>Dinesh</given-names>
</name>
<degrees>MD, MS</degrees>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Berrocal</surname>
<given-names>Veronica J.</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="A2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Giannini</surname>
<given-names>Edward H.</given-names>
</name>
<degrees>MSc, DrPH</degrees>
<xref ref-type="aff" rid="A3">3</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Seibold</surname>
<given-names>James R.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A4">4</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Merkel</surname>
<given-names>Peter A.</given-names>
</name>
<degrees>MD, MPH</degrees>
<xref ref-type="aff" rid="A5">5</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Mayes</surname>
<given-names>Maureen D.</given-names>
</name>
<degrees>MD, MPH</degrees>
<xref ref-type="aff" rid="A6">6</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Baron</surname>
<given-names>Murray</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A7"> 7</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Clements</surname>
<given-names>Philip J.</given-names>
</name>
<degrees>MD, MPH</degrees>
<xref ref-type="aff" rid="A8">8</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Steen</surname>
<given-names>Virginia</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A9">9</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Assassi</surname>
<given-names>Shervin</given-names>
</name>
<degrees>MD, MS</degrees>
<xref ref-type="aff" rid="A6">6</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Schiopu</surname>
<given-names>Elena</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Phillips</surname>
<given-names>Kristine</given-names>
</name>
<degrees>MD, PhD</degrees>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Simms</surname>
<given-names>Robert W.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A10">10</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Allanore</surname>
<given-names>Yannick</given-names>
</name>
<degrees>MD, PhD</degrees>
<xref ref-type="aff" rid="A11">11</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Denton</surname>
<given-names>Christopher P.</given-names>
</name>
<degrees>MD, PhD</degrees>
<xref ref-type="aff" rid="A12">12</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Distler</surname>
<given-names>Oliver</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A13">13</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Johnson</surname>
<given-names>Sindhu R.</given-names>
</name>
<degrees>MD, PhD</degrees>
<xref ref-type="aff" rid="A14">14</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Matucci-Cerinic</surname>
<given-names>Marco</given-names>
</name>
<degrees>MD, PhD</degrees>
<xref ref-type="aff" rid="A15">15</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Pope</surname>
<given-names>Janet</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A16">16</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Proudman</surname>
<given-names>Susanna M.</given-names>
</name>
<degrees>MBBS</degrees>
<xref ref-type="aff" rid="A17">17</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Siegel</surname>
<given-names>Jeffrey</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A18">18</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Wong</surname>
<given-names>Weng Kee</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="A8">8</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Wells</surname>
<given-names>Athol U.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A19">19</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Furst</surname>
<given-names>Daniel E.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A8">8</xref>
</contrib>
</contrib-group>
<aff id="A1"><label>1</label>
University of Michigan Scleroderma Program, Ann Arbor, MI, USA</aff>
<aff id="A2"><label>2</label>
University of Michigan, School of Public Health, Ann Arbor, MI, USA</aff>
<aff id="A3"><label>3</label>
Cincinnati Children’s Hospital, Cincinnati, OH, USA</aff>
<aff id="A4"><label>4</label>
Scleroderma Research Consultants, Litchfield, CT, USA</aff>
<aff id="A5"><label>5</label>
University of Pennsylvania, Philadelphia, PA, USA</aff>
<aff id="A6"><label>6</label>
University of Texas Health Science Center Houston, TX, USA</aff>
<aff id="A7"><label> 7</label>
Jewish General Hospital, McGill University, Montreal, Quebec, Canada</aff>
<aff id="A8"><label>8</label>
UCLA, Los Angeles, CA, USA</aff>
<aff id="A9"><label>9</label>
Georgetown University, Washington, DC, USA</aff>
<aff id="A10"><label>10</label>
Boston University, Boston, MA, USA</aff>
<aff id="A11"><label>11</label>
Paris Descartes University, Cochin Hospital, Paris, France</aff>
<aff id="A12"><label>12</label>
Centre for Rheumatology, Royal Free and University College London Medical School, London, UK</aff>
<aff id="A13"><label>13</label>
Division of Rheumatology, University Hospital Zurich, Zurich, Switzerland</aff>
<aff id="A14"><label>14</label>
Toronto Scleroderma Program, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada</aff>
<aff id="A15"><label>15</label>
Department of Experimental & Clinical Medicine, Division of Rheumatology AOUC, University of Florence, Firenze, Italy</aff>
<aff id="A16"><label>16</label>
Schulich School of Medicine, Western University, London and St Joseph's Health Care, London, ON</aff>
<aff id="A17"><label>17</label>
Royal Adelaide Hospital, North Terrace and Discipline of Medicine, University of Adelaide, Adelaide, SA, Australia</aff>
<aff id="A18"><label>18</label>
Genentech/Roche, San Francisco, CA, USA</aff>
<aff id="A19"><label>19</label>
Royal Brompton Hospital, London, UK</aff>
<author-notes><corresp id="CR1"><bold>Corresponding author</bold>
Dinesh Khanna, MD, MSc, Professor of Medicine, Director, University of Michigan Scleroderma Program, Division of Rheumatology/Dept. of Internal Medicine Suite 7C27, 300 North Ingalls Street, SPC 5422, Ann Arbor, MI 48109, <email>khannad@med.umich.edu</email>
, Phone: 734.647.8173, Fax: 734.763.5761</corresp>
</author-notes>
<pub-date pub-type="nihms-submitted"><day>22</day>
<month>3</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="ppub"><month>2</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>01</day>
<month>2</month>
<year>2017</year>
</pub-date>
<volume>68</volume>
<issue>2</issue>
<fpage>299</fpage>
<lpage>311</lpage>
<pmc-comment>elocation-id from pubmed: 10.1002/art.39501</pmc-comment>
<abstract><sec id="S1"><title>Introduction</title>
<p id="P1">Early diffuse cutaneous systemic sclerosis (dcSSc) is characterized by rapid changes of skin and internal organs. Our objective was to develop a composite response index in dcSSc (abbreviated CRISS) for use in randomized controlled trial (RCT.</p>
</sec>
<sec id="S2"><title>Methods</title>
<p id="P2">We developed 150 paper patient profiles with standardized clinical outcome elements (core set items) using patients with dcSSc. Forty scleroderma experts rated 20 patient profiles each and assessed whether each patient had improved or not over a period of 1 year. Using profiles where raters reached a consensus on whether the patients were improved vs. not (79% of profiles examined), we fit logistic regression models where the binary outcome referred to whether the patient was improved or not, and the change in the core set items from baseline to follow-up were entered as covariates. We tested the final index in a previously completed RCT.</p>
</sec>
<sec id="S3"><title>Results</title>
<p id="P3">Sixteen of 31 core items were included in the patient profiles after a consensus meeting and review of test characteristics of patient-level data. The logistic regression model that included the following core set items: changes in the Rodnan skin score, forced vital capacity (FVC)% predicted, patient and physician global assessments, and HAQ-DI over 1 year had sensitivity of 0.982 (95%CI: 0.981-0.983), specificity of 0.931 (95% CI: 0.930-0.932), and had the highest face validity. Subjects with a significant decline in renal or cardiopulmonary involvement were classified as not improved, regardless of improvements in other core items. The index was able to differentiate the effect of methotrexate from placebo in a 1-year RCT (p< 0.05).</p>
</sec>
<sec id="S4"><title>Conclusion</title>
<p id="P4">We have developed CRISS that is appropriate for use as an outcome assessment in RCT of early dcSSc.</p>
</sec>
</abstract>
</article-meta>
</front>
</pmc>
<affiliations><list><country><li>Australie</li>
<li>Canada</li>
<li>France</li>
<li>Italie</li>
<li>Royaume-Uni</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region><li>Angleterre</li>
<li>Californie</li>
<li>Connecticut</li>
<li>District de Columbia</li>
<li>Grand Londres</li>
<li>Massachusetts</li>
<li>Michigan</li>
<li>Ohio</li>
<li>Ontario</li>
<li>Pennsylvanie</li>
<li>Québec</li>
<li>Texas</li>
<li>Île-de-France</li>
</region>
<settlement><li>Londres</li>
<li>Montréal</li>
<li>Paris</li>
<li>Toronto</li>
</settlement>
<orgName><li>Université McGill</li>
<li>Université de Toronto</li>
</orgName>
</list>
<tree><noCountry><name sortKey="Pope, Janet" sort="Pope, Janet" uniqKey="Pope J" first="Janet" last="Pope">Janet Pope</name>
</noCountry>
<country name="États-Unis"><region name="Michigan"><name sortKey="Khanna, Dinesh" sort="Khanna, Dinesh" uniqKey="Khanna D" first="Dinesh" last="Khanna">Dinesh Khanna</name>
</region>
<name sortKey="Assassi, Shervin" sort="Assassi, Shervin" uniqKey="Assassi S" first="Shervin" last="Assassi">Shervin Assassi</name>
<name sortKey="Berrocal, Veronica J" sort="Berrocal, Veronica J" uniqKey="Berrocal V" first="Veronica J." last="Berrocal">Veronica J. Berrocal</name>
<name sortKey="Clements, Philip J" sort="Clements, Philip J" uniqKey="Clements P" first="Philip J." last="Clements">Philip J. Clements</name>
<name sortKey="Furst, Daniel E" sort="Furst, Daniel E" uniqKey="Furst D" first="Daniel E." last="Furst">Daniel E. Furst</name>
<name sortKey="Giannini, Edward H" sort="Giannini, Edward H" uniqKey="Giannini E" first="Edward H." last="Giannini">Edward H. Giannini</name>
<name sortKey="Mayes, Maureen D" sort="Mayes, Maureen D" uniqKey="Mayes M" first="Maureen D." last="Mayes">Maureen D. Mayes</name>
<name sortKey="Merkel, Peter A" sort="Merkel, Peter A" uniqKey="Merkel P" first="Peter A." last="Merkel">Peter A. Merkel</name>
<name sortKey="Phillips, Kristine" sort="Phillips, Kristine" uniqKey="Phillips K" first="Kristine" last="Phillips">Kristine Phillips</name>
<name sortKey="Schiopu, Elena" sort="Schiopu, Elena" uniqKey="Schiopu E" first="Elena" last="Schiopu">Elena Schiopu</name>
<name sortKey="Seibold, James R" sort="Seibold, James R" uniqKey="Seibold J" first="James R." last="Seibold">James R. Seibold</name>
<name sortKey="Siegel, Jeffrey" sort="Siegel, Jeffrey" uniqKey="Siegel J" first="Jeffrey" last="Siegel">Jeffrey Siegel</name>
<name sortKey="Simms, Robert W" sort="Simms, Robert W" uniqKey="Simms R" first="Robert W." last="Simms">Robert W. Simms</name>
<name sortKey="Steen, Virginia" sort="Steen, Virginia" uniqKey="Steen V" first="Virginia" last="Steen">Virginia Steen</name>
<name sortKey="Wong, Weng Kee" sort="Wong, Weng Kee" uniqKey="Wong W" first="Weng Kee" last="Wong">Weng Kee Wong</name>
</country>
<country name="Canada"><region name="Québec"><name sortKey="Baron, Murray" sort="Baron, Murray" uniqKey="Baron M" first="Murray" last="Baron">Murray Baron</name>
</region>
<name sortKey="Johnson, Sindhu R" sort="Johnson, Sindhu R" uniqKey="Johnson S" first="Sindhu R." last="Johnson">Sindhu R. Johnson</name>
</country>
<country name="France"><region name="Île-de-France"><name sortKey="Allanore, Yannick" sort="Allanore, Yannick" uniqKey="Allanore Y" first="Yannick" last="Allanore">Yannick Allanore</name>
</region>
</country>
<country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Denton, Christopher P" sort="Denton, Christopher P" uniqKey="Denton C" first="Christopher P." last="Denton">Christopher P. Denton</name>
</region>
<name sortKey="Wells, Athol U" sort="Wells, Athol U" uniqKey="Wells A" first="Athol U." last="Wells">Athol U. Wells</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="Italie"><noRegion><name sortKey="Matucci Cerinic, Marco" sort="Matucci Cerinic, Marco" uniqKey="Matucci Cerinic M" first="Marco" last="Matucci-Cerinic">Marco Matucci-Cerinic</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>
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