AustralieFrV1, Ncbi, Merge, bibRecord, 003052

The American College of Rheumatology provisional composite response index for clinical trials in early diffuse cutaneous systemic sclerosis

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The 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.

RBID : PMC:4826472

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

Introduction

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.

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 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.

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. 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).

Conclusion

We have developed CRISS that is appropriate for use as an outcome assessment in RCT of early dcSSc.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4826472

DOI: 10.1002/art.39501
PubMed: 26808827
PubMed Central: 4826472

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Le document en format XML

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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="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>
<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>
<placeName><region type="state">Michigan</region>
</placeName>
</affiliation>
</author>
<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>
<wicri:regionArea>University of Michigan Scleroderma Program, Ann Arbor, MI</wicri:regionArea>
<placeName><region type="state">Michigan</region>
</placeName>
</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: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>
</affiliation>
</author>
<author><name sortKey="Allanore, Yannick" sort="Allanore, Yannick" uniqKey="Allanore Y" first="Yannick" last="Allanore">Yannick Allanore</name>
<affiliation wicri:level="3"><nlm:aff id="A11">Paris Descartes University, Cochin Hospital, Paris, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Paris Descartes University, Cochin Hospital, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</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="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><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"><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>
<double pmid="26808827"><pmc><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 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>
<placeName><region type="state">Michigan</region>
</placeName>
</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 wicri:level="2"><nlm:aff id="A2">University of Michigan, School of Public Health, Ann Arbor, MI, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Michigan, School of Public Health, Ann Arbor, MI</wicri:regionArea>
<placeName><region type="state">Michigan</region>
</placeName>
</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:aff id="A3">Cincinnati Children’s Hospital, Cincinnati, OH, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cincinnati Children’s Hospital, Cincinnati, OH</wicri:regionArea>
<placeName><region type="state">Ohio</region>
</placeName>
</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:aff id="A4">Scleroderma Research Consultants, Litchfield, CT, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Scleroderma Research Consultants, Litchfield, CT</wicri:regionArea>
<placeName><region type="state">Connecticut</region>
</placeName>
</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="2"><nlm:aff id="A5">University of Pennsylvania, Philadelphia, PA, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Pennsylvania, Philadelphia, PA</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</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 wicri:level="2"><nlm:aff id="A6">University of Texas Health Science Center Houston, TX, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Texas Health Science Center Houston, TX</wicri:regionArea>
<placeName><region type="state">Texas</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Baron, Murray" sort="Baron, Murray" uniqKey="Baron M" first="Murray" last="Baron">Murray Baron</name>
<affiliation wicri:level="4"><nlm:aff id="A7">Jewish General Hospital, McGill University, Montreal, Quebec, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Jewish General Hospital, McGill University, Montreal, Quebec</wicri:regionArea>
<orgName type="university">Université McGill</orgName>
<placeName><settlement type="city">Montréal</settlement>
<region type="state">Québec</region>
</placeName>
</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="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="Steen, Virginia" sort="Steen, Virginia" uniqKey="Steen V" first="Virginia" last="Steen">Virginia Steen</name>
<affiliation wicri:level="2"><nlm:aff id="A9">Georgetown University, Washington, DC, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Georgetown University, Washington, DC</wicri:regionArea>
<placeName><region type="state">District de Columbia</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Assassi, Shervin" sort="Assassi, Shervin" uniqKey="Assassi S" first="Shervin" last="Assassi">Shervin Assassi</name>
<affiliation wicri:level="2"><nlm:aff id="A6">University of Texas Health Science Center Houston, TX, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Texas Health Science Center Houston, TX</wicri:regionArea>
<placeName><region type="state">Texas</region>
</placeName>
</affiliation>
</author>
<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>
<placeName><region type="state">Michigan</region>
</placeName>
</affiliation>
</author>
<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>
<wicri:regionArea>University of Michigan Scleroderma Program, Ann Arbor, MI</wicri:regionArea>
<placeName><region type="state">Michigan</region>
</placeName>
</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: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>
</affiliation>
</author>
<author><name sortKey="Allanore, Yannick" sort="Allanore, Yannick" uniqKey="Allanore Y" first="Yannick" last="Allanore">Yannick Allanore</name>
<affiliation wicri:level="3"><nlm:aff id="A11">Paris Descartes University, Cochin Hospital, Paris, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Paris Descartes University, Cochin Hospital, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</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="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>
</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>
<idno type="wicri:Area/Pmc/Curation">001D46</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">001D46</idno>
<idno type="wicri:Area/Pmc/Checkpoint">000576</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000576</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 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>
<placeName><region type="state">Michigan</region>
</placeName>
</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 wicri:level="2"><nlm:aff id="A2">University of Michigan, School of Public Health, Ann Arbor, MI, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Michigan, School of Public Health, Ann Arbor, MI</wicri:regionArea>
<placeName><region type="state">Michigan</region>
</placeName>
</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:aff id="A3">Cincinnati Children’s Hospital, Cincinnati, OH, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cincinnati Children’s Hospital, Cincinnati, OH</wicri:regionArea>
<placeName><region type="state">Ohio</region>
</placeName>
</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:aff id="A4">Scleroderma Research Consultants, Litchfield, CT, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Scleroderma Research Consultants, Litchfield, CT</wicri:regionArea>
<placeName><region type="state">Connecticut</region>
</placeName>
</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="2"><nlm:aff id="A5">University of Pennsylvania, Philadelphia, PA, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Pennsylvania, Philadelphia, PA</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</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 wicri:level="2"><nlm:aff id="A6">University of Texas Health Science Center Houston, TX, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Texas Health Science Center Houston, TX</wicri:regionArea>
<placeName><region type="state">Texas</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Baron, Murray" sort="Baron, Murray" uniqKey="Baron M" first="Murray" last="Baron">Murray Baron</name>
<affiliation wicri:level="4"><nlm:aff id="A7">Jewish General Hospital, McGill University, Montreal, Quebec, Canada</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Jewish General Hospital, McGill University, Montreal, Quebec</wicri:regionArea>
<orgName type="university">Université McGill</orgName>
<placeName><settlement type="city">Montréal</settlement>
<region type="state">Québec</region>
</placeName>
</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="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="Steen, Virginia" sort="Steen, Virginia" uniqKey="Steen V" first="Virginia" last="Steen">Virginia Steen</name>
<affiliation wicri:level="2"><nlm:aff id="A9">Georgetown University, Washington, DC, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Georgetown University, Washington, DC</wicri:regionArea>
<placeName><region type="state">District de Columbia</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Assassi, Shervin" sort="Assassi, Shervin" uniqKey="Assassi S" first="Shervin" last="Assassi">Shervin Assassi</name>
<affiliation wicri:level="2"><nlm:aff id="A6">University of Texas Health Science Center Houston, TX, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Texas Health Science Center Houston, TX</wicri:regionArea>
<placeName><region type="state">Texas</region>
</placeName>
</affiliation>
</author>
<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>
<placeName><region type="state">Michigan</region>
</placeName>
</affiliation>
</author>
<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>
<wicri:regionArea>University of Michigan Scleroderma Program, Ann Arbor, MI</wicri:regionArea>
<placeName><region type="state">Michigan</region>
</placeName>
</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: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>
</affiliation>
</author>
<author><name sortKey="Allanore, Yannick" sort="Allanore, Yannick" uniqKey="Allanore Y" first="Yannick" last="Allanore">Yannick Allanore</name>
<affiliation wicri:level="3"><nlm:aff id="A11">Paris Descartes University, Cochin Hospital, Paris, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Paris Descartes University, Cochin Hospital, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</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="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>
<pubmed><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: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>
<wicri:noRegion>Quebec</wicri:noRegion>
</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="3"><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>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</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="3"><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>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</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="3"><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>
<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:affiliation>University Hospital Zurich, Zurich, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>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: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>
<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: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>
<wicri:noRegion>Florence</wicri:noRegion>
</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>
<wicri:noRegion>Ontario</wicri:noRegion>
</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>
<wicri:noRegion>South Australia</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: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="3"><nlm:affiliation>Royal Brompton Hospital, London, UK.</nlm:affiliation>
<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="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>
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<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>
<wicri:noRegion>Quebec</wicri:noRegion>
</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="3"><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>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</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="3"><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>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</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="3"><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>
<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:affiliation>University Hospital Zurich, Zurich, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>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: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>
<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: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>
<wicri:noRegion>Florence</wicri:noRegion>
</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>
<wicri:noRegion>Ontario</wicri:noRegion>
</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>
<wicri:noRegion>South Australia</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: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="3"><nlm:affiliation>Royal Brompton Hospital, London, UK.</nlm:affiliation>
<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="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>
</double>
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The American College of Rheumatology provisional composite response index for clinical trials in early diffuse cutaneous systemic sclerosis

The American College of Rheumatology provisional composite response index for clinical trials in early diffuse cutaneous systemic sclerosis

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