Links to Exploration step
Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">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><nlm:aff id="A1">University of Michigan Scleroderma Program, Ann Arbor, MI, USA</nlm:aff></affiliation></author><author><name sortKey="Berrocal, Veronica J" sort="Berrocal, Veronica J" uniqKey="Berrocal V" first="Veronica J." last="Berrocal">Veronica J. Berrocal</name><affiliation><nlm:aff id="A2">University of Michigan, School of Public Health, Ann Arbor, MI, USA</nlm:aff></affiliation></author><author><name sortKey="Giannini, Edward H" sort="Giannini, Edward H" uniqKey="Giannini E" first="Edward H." last="Giannini">Edward H. Giannini</name><affiliation><nlm:aff id="A3">Cincinnati Children’s Hospital, Cincinnati, OH, USA</nlm:aff></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><nlm:aff id="A4">Scleroderma Research Consultants, Litchfield, CT, USA</nlm:aff></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><nlm:aff id="A5">University of Pennsylvania, Philadelphia, PA, USA</nlm:aff></affiliation></author><author><name sortKey="Mayes, Maureen D" sort="Mayes, Maureen D" uniqKey="Mayes M" first="Maureen D." last="Mayes">Maureen D. Mayes</name><affiliation><nlm:aff id="A6">University of Texas Health Science Center Houston, TX, USA</nlm:aff></affiliation></author><author><name sortKey="Baron, Murray" sort="Baron, Murray" uniqKey="Baron M" first="Murray" last="Baron">Murray Baron</name><affiliation><nlm:aff id="A7">Jewish General Hospital, McGill University, Montreal, Quebec, Canada</nlm:aff></affiliation></author><author><name sortKey="Clements, Philip J" sort="Clements, Philip J" uniqKey="Clements P" first="Philip J." last="Clements">Philip J. Clements</name><affiliation><nlm:aff id="A8">UCLA, Los Angeles, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Steen, Virginia" sort="Steen, Virginia" uniqKey="Steen V" first="Virginia" last="Steen">Virginia Steen</name><affiliation><nlm:aff id="A9">Georgetown University, Washington, DC, USA</nlm:aff></affiliation></author><author><name sortKey="Assassi, Shervin" sort="Assassi, Shervin" uniqKey="Assassi S" first="Shervin" last="Assassi">Shervin Assassi</name><affiliation><nlm:aff id="A6">University of Texas Health Science Center Houston, TX, USA</nlm:aff></affiliation></author><author><name sortKey="Schiopu, Elena" sort="Schiopu, Elena" uniqKey="Schiopu E" first="Elena" last="Schiopu">Elena Schiopu</name><affiliation><nlm:aff id="A1">University of Michigan Scleroderma Program, Ann Arbor, MI, USA</nlm:aff></affiliation></author><author><name sortKey="Phillips, Kristine" sort="Phillips, Kristine" uniqKey="Phillips K" first="Kristine" last="Phillips">Kristine Phillips</name><affiliation><nlm:aff id="A1">University of Michigan Scleroderma Program, Ann Arbor, MI, USA</nlm:aff></affiliation></author><author><name sortKey="Simms, Robert W" sort="Simms, Robert W" uniqKey="Simms R" first="Robert W." last="Simms">Robert W. Simms</name><affiliation><nlm:aff id="A10">Boston University, Boston, MA, USA</nlm:aff></affiliation></author><author><name sortKey="Allanore, Yannick" sort="Allanore, Yannick" uniqKey="Allanore Y" first="Yannick" last="Allanore">Yannick Allanore</name><affiliation><nlm:aff id="A11">Paris Descartes University, Cochin Hospital, Paris, France</nlm:aff></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><nlm:aff id="A12">Centre for Rheumatology, Royal Free and University College London Medical School, London, UK</nlm:aff></affiliation></author><author><name sortKey="Distler, Oliver" sort="Distler, Oliver" uniqKey="Distler O" first="Oliver" last="Distler">Oliver Distler</name><affiliation><nlm:aff id="A13">Division of Rheumatology, University Hospital Zurich, Zurich, Switzerland</nlm:aff></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><nlm:aff id="A14">Toronto Scleroderma Program, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada</nlm:aff></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><nlm:aff id="A15"> Department of Experimental & Clinical Medicine, Division of Rheumatology AOUC, University of Florence, Firenze, Italy</nlm:aff></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></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><nlm:aff id="A17">Royal Adelaide Hospital, North Terrace and Discipline of Medicine, University of Adelaide, Adelaide, SA, Australia</nlm:aff></affiliation></author><author><name sortKey="Siegel, Jeffrey" sort="Siegel, Jeffrey" uniqKey="Siegel J" first="Jeffrey" last="Siegel">Jeffrey Siegel</name><affiliation><nlm:aff id="A18">Genentech/Roche, San Francisco, CA, USA</nlm:aff></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><nlm:aff id="A8">UCLA, Los Angeles, CA, USA</nlm:aff></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><nlm:aff id="A19">Royal Brompton Hospital, London, UK</nlm:aff></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><nlm:aff id="A8">UCLA, Los Angeles, CA, USA</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26808827</idno><idno type="pmc">4826472</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4826472</idno><idno type="RBID">PMC:4826472</idno><idno type="doi">10.1002/art.39501</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">001E90</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001E90</idno></publicationStmt><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><nlm:aff id="A1">University of Michigan Scleroderma Program, Ann Arbor, MI, USA</nlm:aff></affiliation></author><author><name sortKey="Berrocal, Veronica J" sort="Berrocal, Veronica J" uniqKey="Berrocal V" first="Veronica J." last="Berrocal">Veronica J. Berrocal</name><affiliation><nlm:aff id="A2">University of Michigan, School of Public Health, Ann Arbor, MI, USA</nlm:aff></affiliation></author><author><name sortKey="Giannini, Edward H" sort="Giannini, Edward H" uniqKey="Giannini E" first="Edward H." last="Giannini">Edward H. Giannini</name><affiliation><nlm:aff id="A3">Cincinnati Children’s Hospital, Cincinnati, OH, USA</nlm:aff></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><nlm:aff id="A4">Scleroderma Research Consultants, Litchfield, CT, USA</nlm:aff></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><nlm:aff id="A5">University of Pennsylvania, Philadelphia, PA, USA</nlm:aff></affiliation></author><author><name sortKey="Mayes, Maureen D" sort="Mayes, Maureen D" uniqKey="Mayes M" first="Maureen D." last="Mayes">Maureen D. Mayes</name><affiliation><nlm:aff id="A6">University of Texas Health Science Center Houston, TX, USA</nlm:aff></affiliation></author><author><name sortKey="Baron, Murray" sort="Baron, Murray" uniqKey="Baron M" first="Murray" last="Baron">Murray Baron</name><affiliation><nlm:aff id="A7">Jewish General Hospital, McGill University, Montreal, Quebec, Canada</nlm:aff></affiliation></author><author><name sortKey="Clements, Philip J" sort="Clements, Philip J" uniqKey="Clements P" first="Philip J." last="Clements">Philip J. Clements</name><affiliation><nlm:aff id="A8">UCLA, Los Angeles, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Steen, Virginia" sort="Steen, Virginia" uniqKey="Steen V" first="Virginia" last="Steen">Virginia Steen</name><affiliation><nlm:aff id="A9">Georgetown University, Washington, DC, USA</nlm:aff></affiliation></author><author><name sortKey="Assassi, Shervin" sort="Assassi, Shervin" uniqKey="Assassi S" first="Shervin" last="Assassi">Shervin Assassi</name><affiliation><nlm:aff id="A6">University of Texas Health Science Center Houston, TX, USA</nlm:aff></affiliation></author><author><name sortKey="Schiopu, Elena" sort="Schiopu, Elena" uniqKey="Schiopu E" first="Elena" last="Schiopu">Elena Schiopu</name><affiliation><nlm:aff id="A1">University of Michigan Scleroderma Program, Ann Arbor, MI, USA</nlm:aff></affiliation></author><author><name sortKey="Phillips, Kristine" sort="Phillips, Kristine" uniqKey="Phillips K" first="Kristine" last="Phillips">Kristine Phillips</name><affiliation><nlm:aff id="A1">University of Michigan Scleroderma Program, Ann Arbor, MI, USA</nlm:aff></affiliation></author><author><name sortKey="Simms, Robert W" sort="Simms, Robert W" uniqKey="Simms R" first="Robert W." last="Simms">Robert W. Simms</name><affiliation><nlm:aff id="A10">Boston University, Boston, MA, USA</nlm:aff></affiliation></author><author><name sortKey="Allanore, Yannick" sort="Allanore, Yannick" uniqKey="Allanore Y" first="Yannick" last="Allanore">Yannick Allanore</name><affiliation><nlm:aff id="A11">Paris Descartes University, Cochin Hospital, Paris, France</nlm:aff></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><nlm:aff id="A12">Centre for Rheumatology, Royal Free and University College London Medical School, London, UK</nlm:aff></affiliation></author><author><name sortKey="Distler, Oliver" sort="Distler, Oliver" uniqKey="Distler O" first="Oliver" last="Distler">Oliver Distler</name><affiliation><nlm:aff id="A13">Division of Rheumatology, University Hospital Zurich, Zurich, Switzerland</nlm:aff></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><nlm:aff id="A14">Toronto Scleroderma Program, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada</nlm:aff></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><nlm:aff id="A15"> Department of Experimental & Clinical Medicine, Division of Rheumatology AOUC, University of Florence, Firenze, Italy</nlm:aff></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></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><nlm:aff id="A17">Royal Adelaide Hospital, North Terrace and Discipline of Medicine, University of Adelaide, Adelaide, SA, Australia</nlm:aff></affiliation></author><author><name sortKey="Siegel, Jeffrey" sort="Siegel, Jeffrey" uniqKey="Siegel J" first="Jeffrey" last="Siegel">Jeffrey Siegel</name><affiliation><nlm:aff id="A18">Genentech/Roche, San Francisco, CA, USA</nlm:aff></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><nlm:aff id="A8">UCLA, Los Angeles, CA, USA</nlm:aff></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><nlm:aff id="A19">Royal Brompton Hospital, London, UK</nlm:aff></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><nlm:aff id="A8">UCLA, Los Angeles, CA, USA</nlm:aff></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></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Asie/explor/AustralieFrV1/Data/Pmc/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001E90 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Pmc/Corpus/biblio.hfd -nk 001E90 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Asie
|area= AustralieFrV1
|flux= Pmc
|étape= Corpus
|type= RBID
|clé=
|texte=
}}
| This area was generated with Dilib version V0.6.33. |  |