The American College of Rheumatology Provisional Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis.
Identifieur interne : 002276 ( PubMed/Curation ); précédent : 002275; suivant : 002277The American College of Rheumatology Provisional Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis.
Auteurs : Dinesh Khanna ; Veronica J. Berrocal ; Edward H. Giannini [États-Unis] ; James R. Seibold [États-Unis] ; Peter A. Merkel [États-Unis] ; Maureen D. Mayes ; Murray Baron [Canada] ; Philip J. Clements [États-Unis] ; Virginia Steen [France] ; Shervin Assassi ; Elena Schiopu ; Kristine Phillips ; 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 E. Pope [Canada] ; 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.) [ 2326-5205 ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Antirhumatismaux (usage thérapeutique), Essais contrôlés randomisés comme sujet, Femelle, Humains, Modèles logistiques, Mâle, Méthotrexate (usage thérapeutique), Reproductibilité des résultats, Rhumatologie, Sclérodermie diffuse (traitement médicamenteux), Sociétés médicales, Études de cohortes, Études longitudinales, Évaluation de résultat (soins).
- MESH :
- traitement médicamenteux : Sclérodermie diffuse.
- usage thérapeutique : Antirhumatismaux, Méthotrexate.
- Adulte, Adulte d'âge moyen, Essais contrôlés randomisés comme sujet, Femelle, Humains, Modèles logistiques, Mâle, Reproductibilité des résultats, Rhumatologie, Sociétés médicales, Études de cohortes, Études longitudinales, Évaluation de résultat (soins).
English descriptors
- KwdEn :
- Adult, Antirheumatic Agents (therapeutic use), Cohort Studies, Female, Humans, Logistic Models, Longitudinal Studies, Male, Methotrexate (therapeutic use), Middle Aged, Outcome Assessment (Health Care), Randomized Controlled Trials as Topic, Reproducibility of Results, Rheumatology, Scleroderma, Diffuse (drug therapy), Societies, Medical.
- MESH :
- chemical , therapeutic use : Antirheumatic Agents, Methotrexate.
- drug therapy : Scleroderma, Diffuse.
- Adult, Cohort Studies, Female, Humans, Logistic Models, Longitudinal Studies, Male, Middle Aged, Outcome Assessment (Health Care), Randomized Controlled Trials as Topic, Reproducibility of Results, Rheumatology, Societies, Medical.
Abstract
Early diffuse cutaneous systemic sclerosis (dcSSc) is characterized by rapid changes in the skin and internal organs. The objective of this study was to develop a composite response index in dcSSc (CRISS) for use in randomized controlled trials (RCTs).
DOI: 10.1002/art.39501
PubMed: 26808827
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Dinesh Khanna<affiliation><nlm:affiliation>University of Michigan, Ann Arbor.</nlm:affiliation><wicri:noCountry code="subField">Ann Arbor</wicri:noCountry></affiliation><affiliation><nlm:affiliation>University of Michigan, Ann Arbor.</nlm:affiliation><wicri:noCountry code="subField">Ann Arbor</wicri:noCountry></affiliation><affiliation><nlm:affiliation>University of Texas Health Science Center at Houston.</nlm:affiliation><wicri:noCountry code="no comma">University of Texas Health Science Center at Houston.</wicri:noCountry></affiliation><affiliation><nlm:affiliation>University of Texas Health Science Center at Houston.</nlm:affiliation><wicri:noCountry code="no comma">University of Texas Health Science Center at Houston.</wicri:noCountry></affiliation><affiliation><nlm:affiliation>University of Michigan, Ann Arbor.</nlm:affiliation><wicri:noCountry code="subField">Ann Arbor</wicri:noCountry></affiliation><affiliation><nlm:affiliation>University of Michigan, Ann Arbor.</nlm:affiliation><wicri:noCountry code="subField">Ann Arbor</wicri:noCountry></affiliation>Le document en format XML
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Merkel</name><affiliation wicri:level="3"><nlm:affiliation>University of Pennsylvania, Philadelphia.</nlm:affiliation><country>États-Unis</country><placeName><settlement type="city">Philadelphie</settlement><region type="state">Pennsylvanie</region></placeName><wicri:orgArea>University of Pennsylvania</wicri:orgArea></affiliation></author><author><name sortKey="Mayes, Maureen D" sort="Mayes, Maureen D" uniqKey="Mayes M" first="Maureen D" last="Mayes">Maureen D. 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Clements</name><affiliation wicri:level="3"><nlm:affiliation>University of California, Los Angeles.</nlm:affiliation><country>États-Unis</country><placeName><settlement type="city">Los Angeles</settlement><region type="state">Californie</region></placeName><wicri:orgArea>University of California</wicri:orgArea></affiliation></author><author><name sortKey="Steen, Virginia" sort="Steen, Virginia" uniqKey="Steen V" first="Virginia" last="Steen">Virginia Steen</name><affiliation wicri:level="1"><nlm:affiliation>Paris Descartes University and Cochin Hospital, AP-HP, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Paris Descartes University and Cochin Hospital, AP-HP, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Assassi, Shervin" sort="Assassi, Shervin" uniqKey="Assassi S" first="Shervin" last="Assassi">Shervin Assassi</name><affiliation><nlm:affiliation>University of Texas Health Science Center at Houston.</nlm:affiliation><wicri:noCountry code="no comma">University of Texas Health Science Center at Houston.</wicri:noCountry></affiliation></author><author><name sortKey="Schiopu, Elena" sort="Schiopu, Elena" uniqKey="Schiopu E" first="Elena" last="Schiopu">Elena Schiopu</name><affiliation><nlm:affiliation>University of Michigan, Ann Arbor.</nlm:affiliation><wicri:noCountry code="subField">Ann Arbor</wicri:noCountry></affiliation></author><author><name sortKey="Phillips, Kristine" sort="Phillips, Kristine" uniqKey="Phillips K" first="Kristine" last="Phillips">Kristine Phillips</name><affiliation><nlm:affiliation>University of Michigan, Ann Arbor.</nlm:affiliation><wicri:noCountry code="subField">Ann Arbor</wicri:noCountry></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 wicri:level="2"><nlm:affiliation>Boston University, Boston, Massachusetts.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Boston University, Boston</wicri:cityArea></affiliation></author><author><name sortKey="Allanore, Yannick" sort="Allanore, Yannick" uniqKey="Allanore Y" first="Yannick" last="Allanore">Yannick Allanore</name><affiliation wicri:level="1"><nlm:affiliation>Paris Descartes University and Cochin Hospital, AP-HP, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Paris Descartes University and Cochin Hospital, AP-HP, Paris</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:affiliation>Royal Free and University College London Medical School, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Royal Free and University College London Medical School, London</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:affiliation>University Hospital Zurich, Zurich, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>University Hospital Zurich, Zurich</wicri:regionArea></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="1"><nlm:affiliation>Toronto Western Hospital and University of Toronto, Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Toronto Western Hospital and University of Toronto, Toronto, Ontario</wicri:regionArea></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:affiliation>Azienda Ospedaliero-Universitaria Careggi (AOUC) and University of Florence, Florence, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Azienda Ospedaliero-Universitaria Careggi (AOUC) and University of Florence, Florence</wicri:regionArea></affiliation></author><author><name sortKey="Pope, Janet E" sort="Pope, Janet E" uniqKey="Pope J" first="Janet E" last="Pope">Janet E. Pope</name><affiliation wicri:level="1"><nlm:affiliation>Schulich School of Medicine, Western University, London Campus, and St. Joseph's Health Care, London, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Schulich School of Medicine, Western University, London Campus, and St. Joseph's Health Care, London, Ontario</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:affiliation>Royal Adelaide Hospital and University of Adelaide, Adelaide, South Australia, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Royal Adelaide Hospital and University of Adelaide, Adelaide, South Australia</wicri:regionArea></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:affiliation>Genentech/Roche, San Francisco, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Genentech/Roche, San Francisco</wicri:cityArea></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="3"><nlm:affiliation>University of California, Los Angeles.</nlm:affiliation><country>États-Unis</country><placeName><settlement type="city">Los Angeles</settlement><region type="state">Californie</region></placeName><wicri:orgArea>University of California</wicri:orgArea></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:affiliation>Royal Brompton Hospital, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Royal Brompton Hospital, London</wicri:regionArea></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="3"><nlm:affiliation>University of California, Los Angeles.</nlm:affiliation><country>États-Unis</country><placeName><settlement type="city">Los Angeles</settlement><region type="state">Californie</region></placeName><wicri:orgArea>University of California</wicri:orgArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:26808827</idno><idno type="pmid">26808827</idno><idno type="doi">10.1002/art.39501</idno><idno type="wicri:Area/PubMed/Corpus">002302</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">002302</idno><idno type="wicri:Area/PubMed/Curation">002276</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">002276</idno></publicationStmt><sourceDesc><biblStruct><analytic><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:affiliation>University of Michigan, Ann Arbor.</nlm:affiliation><wicri:noCountry code="subField">Ann Arbor</wicri:noCountry></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:affiliation>University of Michigan, Ann Arbor.</nlm:affiliation><wicri:noCountry code="subField">Ann Arbor</wicri:noCountry></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 wicri:level="2"><nlm:affiliation>Cincinnati Children's Hospital, Cincinnati, Ohio.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Ohio</region></placeName><wicri:cityArea>Cincinnati Children's Hospital, Cincinnati</wicri:cityArea></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="2"><nlm:affiliation>Scleroderma Research Consultants, Litchfield, Connecticut.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Connecticut</region></placeName><wicri:cityArea>Scleroderma Research Consultants, Litchfield</wicri:cityArea></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="3"><nlm:affiliation>University of Pennsylvania, Philadelphia.</nlm:affiliation><country>États-Unis</country><placeName><settlement type="city">Philadelphie</settlement><region type="state">Pennsylvanie</region></placeName><wicri:orgArea>University of Pennsylvania</wicri:orgArea></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:affiliation>University of Texas Health Science Center at Houston.</nlm:affiliation><wicri:noCountry code="no comma">University of Texas Health Science Center at Houston.</wicri:noCountry></affiliation></author><author><name sortKey="Baron, Murray" sort="Baron, Murray" uniqKey="Baron M" first="Murray" last="Baron">Murray Baron</name><affiliation wicri:level="1"><nlm:affiliation>Jewish General Hospital and McGill University, Montreal, Quebec, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Jewish General Hospital and McGill University, Montreal, Quebec</wicri:regionArea></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 wicri:level="3"><nlm:affiliation>University of California, Los Angeles.</nlm:affiliation><country>États-Unis</country><placeName><settlement type="city">Los Angeles</settlement><region type="state">Californie</region></placeName><wicri:orgArea>University of California</wicri:orgArea></affiliation></author><author><name sortKey="Steen, Virginia" sort="Steen, Virginia" uniqKey="Steen V" first="Virginia" last="Steen">Virginia Steen</name><affiliation wicri:level="1"><nlm:affiliation>Paris Descartes University and Cochin Hospital, AP-HP, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Paris Descartes University and Cochin Hospital, AP-HP, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Assassi, Shervin" sort="Assassi, Shervin" uniqKey="Assassi S" first="Shervin" last="Assassi">Shervin Assassi</name><affiliation><nlm:affiliation>University of Texas Health Science Center at Houston.</nlm:affiliation><wicri:noCountry code="no comma">University of Texas Health Science Center at Houston.</wicri:noCountry></affiliation></author><author><name sortKey="Schiopu, Elena" sort="Schiopu, Elena" uniqKey="Schiopu E" first="Elena" last="Schiopu">Elena Schiopu</name><affiliation><nlm:affiliation>University of Michigan, Ann Arbor.</nlm:affiliation><wicri:noCountry code="subField">Ann Arbor</wicri:noCountry></affiliation></author><author><name sortKey="Phillips, Kristine" sort="Phillips, Kristine" uniqKey="Phillips K" first="Kristine" last="Phillips">Kristine Phillips</name><affiliation><nlm:affiliation>University of Michigan, Ann Arbor.</nlm:affiliation><wicri:noCountry code="subField">Ann Arbor</wicri:noCountry></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 wicri:level="2"><nlm:affiliation>Boston University, Boston, Massachusetts.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Boston University, Boston</wicri:cityArea></affiliation></author><author><name sortKey="Allanore, Yannick" sort="Allanore, Yannick" uniqKey="Allanore Y" first="Yannick" last="Allanore">Yannick Allanore</name><affiliation wicri:level="1"><nlm:affiliation>Paris Descartes University and Cochin Hospital, AP-HP, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Paris Descartes University and Cochin Hospital, AP-HP, Paris</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:affiliation>Royal Free and University College London Medical School, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Royal Free and University College London Medical School, London</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:affiliation>University Hospital Zurich, Zurich, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>University Hospital Zurich, Zurich</wicri:regionArea></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="1"><nlm:affiliation>Toronto Western Hospital and University of Toronto, Toronto, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Toronto Western Hospital and University of Toronto, Toronto, Ontario</wicri:regionArea></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:affiliation>Azienda Ospedaliero-Universitaria Careggi (AOUC) and University of Florence, Florence, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Azienda Ospedaliero-Universitaria Careggi (AOUC) and University of Florence, Florence</wicri:regionArea></affiliation></author><author><name sortKey="Pope, Janet E" sort="Pope, Janet E" uniqKey="Pope J" first="Janet E" last="Pope">Janet E. Pope</name><affiliation wicri:level="1"><nlm:affiliation>Schulich School of Medicine, Western University, London Campus, and St. Joseph's Health Care, London, Ontario, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Schulich School of Medicine, Western University, London Campus, and St. Joseph's Health Care, London, Ontario</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:affiliation>Royal Adelaide Hospital and University of Adelaide, Adelaide, South Australia, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Royal Adelaide Hospital and University of Adelaide, Adelaide, South Australia</wicri:regionArea></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:affiliation>Genentech/Roche, San Francisco, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Genentech/Roche, San Francisco</wicri:cityArea></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="3"><nlm:affiliation>University of California, Los Angeles.</nlm:affiliation><country>États-Unis</country><placeName><settlement type="city">Los Angeles</settlement><region type="state">Californie</region></placeName><wicri:orgArea>University of California</wicri:orgArea></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:affiliation>Royal Brompton Hospital, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Royal Brompton Hospital, London</wicri:regionArea></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="3"><nlm:affiliation>University of California, Los Angeles.</nlm:affiliation><country>États-Unis</country><placeName><settlement type="city">Los Angeles</settlement><region type="state">Californie</region></placeName><wicri:orgArea>University of California</wicri:orgArea></affiliation></author></analytic><series><title level="j">Arthritis & rheumatology (Hoboken, N.J.)</title><idno type="eISSN">2326-5205</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Antirheumatic Agents (therapeutic use)</term><term>Cohort Studies</term><term>Female</term><term>Humans</term><term>Logistic Models</term><term>Longitudinal Studies</term><term>Male</term><term>Methotrexate (therapeutic use)</term><term>Middle Aged</term><term>Outcome Assessment (Health Care)</term><term>Randomized Controlled Trials as Topic</term><term>Reproducibility of Results</term><term>Rheumatology</term><term>Scleroderma, Diffuse (drug therapy)</term><term>Societies, Medical</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Antirhumatismaux (usage thérapeutique)</term><term>Essais contrôlés randomisés comme sujet</term><term>Femelle</term><term>Humains</term><term>Modèles logistiques</term><term>Mâle</term><term>Méthotrexate (usage thérapeutique)</term><term>Reproductibilité des résultats</term><term>Rhumatologie</term><term>Sclérodermie diffuse (traitement médicamenteux)</term><term>Sociétés médicales</term><term>Études de cohortes</term><term>Études longitudinales</term><term>Évaluation de résultat (soins)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antirheumatic Agents</term><term>Methotrexate</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Scleroderma, Diffuse</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Sclérodermie diffuse</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antirhumatismaux</term><term>Méthotrexate</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Cohort Studies</term><term>Female</term><term>Humans</term><term>Logistic Models</term><term>Longitudinal Studies</term><term>Male</term><term>Middle Aged</term><term>Outcome Assessment (Health Care)</term><term>Randomized Controlled Trials as Topic</term><term>Reproducibility of Results</term><term>Rheumatology</term><term>Societies, Medical</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Essais contrôlés randomisés comme sujet</term><term>Femelle</term><term>Humains</term><term>Modèles logistiques</term><term>Mâle</term><term>Reproductibilité des résultats</term><term>Rhumatologie</term><term>Sociétés médicales</term><term>Études de cohortes</term><term>Études longitudinales</term><term>Évaluation de résultat (soins)</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Early diffuse cutaneous systemic sclerosis (dcSSc) is characterized by rapid changes in the skin and internal organs. The objective of this study was to develop a composite response index in dcSSc (CRISS) for use in randomized controlled trials (RCTs).</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26808827</PMID><DateCreated><Year>2016</Year><Month>01</Month><Day>26</Day></DateCreated><DateCompleted><Year>2016</Year><Month>06</Month><Day>14</Day></DateCompleted><DateRevised><Year>2017</Year><Month>09</Month><Day>22</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">2326-5205</ISSN><JournalIssue CitedMedium="Internet"><Volume>68</Volume><Issue>2</Issue><PubDate><Year>2016</Year><Month>Feb</Month></PubDate></JournalIssue><Title>Arthritis & rheumatology (Hoboken, N.J.)</Title></Journal><ArticleTitle>The American College of Rheumatology Provisional Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis.</ArticleTitle><Pagination><MedlinePgn>299-311</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/art.39501</ELocationID><Abstract><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">Early diffuse cutaneous systemic sclerosis (dcSSc) is characterized by rapid changes in the skin and internal organs. The objective of this study was to develop a composite response index in dcSSc (CRISS) for use in randomized controlled trials (RCTs).</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">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 improved over a period of 1 year. Using the profiles for which raters had reached a consensus on whether the patients were improved versus not improved (79% of the profiles examined), we fit logistic regression models in which the binary outcome referred to whether the patient was improved or not, and the changes in the core set items from baseline to followup were entered as covariates. We tested the final index in a previously completed RCT.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Sixteen of 31 core items were included in the patient profiles after a consensus meeting and review of test characteristics of patient-level data. In the logistic regression model in which the included core set items were change over 1 year in the modified Rodnan skin thickness score, the forced vital capacity, the patient and physician global assessments, and the Health Assessment Questionnaire disability index, sensitivity was 0.982 (95% confidence interval 0.982-0.983) and specificity was 0.931 (95% confidence interval 0.930-0.932), and the model with these 5 items had the highest face validity. Subjects with a significant worsening of renal or cardiopulmonary involvement were classified as not improved, regardless of improvements in other core items. With use of the index, the effect of methotrexate could be differentiated from the effect of placebo in a 1-year RCT (P = 0.02).</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">We have developed a CRISS that is appropriate for use as an outcome assessment in RCTs of early dcSSc.</AbstractText><CopyrightInformation>© 2016, American College of Rheumatology.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Khanna</LastName><ForeName>Dinesh</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>University of Michigan, Ann Arbor.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Berrocal</LastName><ForeName>Veronica J</ForeName><Initials>VJ</Initials><AffiliationInfo><Affiliation>University of Michigan, Ann Arbor.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Giannini</LastName><ForeName>Edward H</ForeName><Initials>EH</Initials><AffiliationInfo><Affiliation>Cincinnati Children's Hospital, Cincinnati, Ohio.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Seibold</LastName><ForeName>James R</ForeName><Initials>JR</Initials><AffiliationInfo><Affiliation>Scleroderma Research Consultants, Litchfield, Connecticut.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Merkel</LastName><ForeName>Peter A</ForeName><Initials>PA</Initials><AffiliationInfo><Affiliation>University of Pennsylvania, Philadelphia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mayes</LastName><ForeName>Maureen D</ForeName><Initials>MD</Initials><AffiliationInfo><Affiliation>University of Texas Health Science Center at Houston.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Baron</LastName><ForeName>Murray</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Jewish General Hospital and McGill University, Montreal, Quebec, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Clements</LastName><ForeName>Philip J</ForeName><Initials>PJ</Initials><AffiliationInfo><Affiliation>University of California, Los Angeles.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Steen</LastName><ForeName>Virginia</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Paris Descartes University and Cochin Hospital, AP-HP, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Assassi</LastName><ForeName>Shervin</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>University of Texas Health Science Center at Houston.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schiopu</LastName><ForeName>Elena</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>University of Michigan, Ann Arbor.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Phillips</LastName><ForeName>Kristine</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>University of Michigan, Ann Arbor.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Simms</LastName><ForeName>Robert W</ForeName><Initials>RW</Initials><AffiliationInfo><Affiliation>Boston University, Boston, Massachusetts.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Allanore</LastName><ForeName>Yannick</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Paris Descartes University and Cochin Hospital, AP-HP, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Denton</LastName><ForeName>Christopher P</ForeName><Initials>CP</Initials><AffiliationInfo><Affiliation>Royal Free and University College London Medical School, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Distler</LastName><ForeName>Oliver</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>University Hospital Zurich, Zurich, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Johnson</LastName><ForeName>Sindhu R</ForeName><Initials>SR</Initials><AffiliationInfo><Affiliation>Toronto Western Hospital and University of Toronto, Toronto, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Matucci-Cerinic</LastName><ForeName>Marco</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Azienda Ospedaliero-Universitaria Careggi (AOUC) and University of Florence, Florence, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pope</LastName><ForeName>Janet E</ForeName><Initials>JE</Initials><AffiliationInfo><Affiliation>Schulich School of Medicine, Western University, London Campus, and St. Joseph's Health Care, London, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Proudman</LastName><ForeName>Susanna M</ForeName><Initials>SM</Initials><AffiliationInfo><Affiliation>Royal Adelaide Hospital and University of Adelaide, Adelaide, South Australia, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Siegel</LastName><ForeName>Jeffrey</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Genentech/Roche, San Francisco, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wong</LastName><ForeName>Weng Kee</ForeName><Initials>WK</Initials><AffiliationInfo><Affiliation>University of California, Los Angeles.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wells</LastName><ForeName>Athol U</ForeName><Initials>AU</Initials><AffiliationInfo><Affiliation>Royal Brompton Hospital, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Furst</LastName><ForeName>Daniel E</ForeName><Initials>DE</Initials><AffiliationInfo><Affiliation>University of California, Los Angeles.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>K24-AR-063120</GrantID><Acronym>AR</Acronym><Agency>NIAMS NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>20719</GrantID><Agency>Arthritis Research UK</Agency><Country>United Kingdom</Country></Grant><Grant><GrantID>K23 AR060241</GrantID><Acronym>AR</Acronym><Agency>NIAMS NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>U01 AR055057</GrantID><Acronym>AR</Acronym><Agency>NIAMS NIH HHS</Agency><Country>United States</Country></Grant><Grant><Agency>Canadian Institutes of Health Research</Agency><Country>Canada</Country></Grant><Grant><GrantID>K24 AR063120</GrantID><Acronym>AR</Acronym><Agency>NIAMS NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>U01-AR-055057</GrantID><Acronym>AR</Acronym><Agency>NIAMS NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016446">Consensus Development Conference</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D064888">Observational Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D052061">Research Support, N.I.H., Extramural</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Arthritis Rheumatol</MedlineTA><NlmUniqueID>101623795</NlmUniqueID><ISSNLinking>2326-5191</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D018501">Antirheumatic Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>YL5FZ2Y5U1</RegistryNumber><NameOfSubstance UI="D008727">Methotrexate</NameOfSubstance></Chemical></ChemicalList><CitationSubset>AIM</CitationSubset><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Ann Rheum Dis. 2011 Jun;70(6):1074-9</RefSource><PMID Version="1">21540204</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Arthritis Rheum. 2008 May 15;59(5):699-705</RefSource><PMID Version="1">18438905</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Semin Arthritis Rheum. 2011 Oct;41(2):95-105</RefSource><PMID Version="1">21420149</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Autoimmun Rev. 2012 Mar;11(5):326-9</RefSource><PMID Version="1">21958603</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Rheumatology (Oxford). 2012 Jun;51(6):1017-26</RefSource><PMID 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UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016015" MajorTopicYN="N">Logistic Models</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008137" MajorTopicYN="N">Longitudinal Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008727" MajorTopicYN="N">Methotrexate</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D017063" MajorTopicYN="Y">Outcome Assessment (Health Care)</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016032" MajorTopicYN="N">Randomized Controlled Trials as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015203" MajorTopicYN="N">Reproducibility of Results</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012219" MajorTopicYN="N">Rheumatology</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D045743" MajorTopicYN="N">Scleroderma, Diffuse</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012955" MajorTopicYN="N">Societies, Medical</DescriptorName></MeshHeading></MeshHeadingList><OtherID Source="NLM">NIHMS771266 [Available on 02/01/17]</OtherID><OtherID Source="NLM">PMC4826472 [Available on 02/01/17]</OtherID></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2014</Year><Month>11</Month><Day>11</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>10</Month><Day>30</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>1</Month><Day>26</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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