Defining Appropriate Outcome Measures in Pulmonary Arterial Hypertension Related to Systemic Sclerosis : A Delphi Consensus Study With Cluster Analysis
Identifieur interne : 008E03 ( Main/Exploration ); précédent : 008E02; suivant : 008E04Defining Appropriate Outcome Measures in Pulmonary Arterial Hypertension Related to Systemic Sclerosis : A Delphi Consensus Study With Cluster Analysis
Auteurs : Oliver Distler [Suisse] ; Frank Behrens [Allemagne] ; David Pittrow [Allemagne] ; Doerte Huscher [Allemagne] ; Christopher P. Denton [Royaume-Uni] ; Ivan Foeldvari [Allemagne] ; Marc Humbert [France] ; Marco Matucci-Cerinic [Italie] ; Peter Nash [Australie] ; Christian F. Opitz [Allemagne] ; Lewis J. Rubin [États-Unis] ; James R. Seibold [États-Unis] ; Daniel E. Furst [États-Unis]Source :
- Arthritis care and research [ 0893-7524 ] ; 2008.
Descripteurs français
- Pascal (Inist)
English descriptors
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Abstract
Objective. Outcome measures for pulmonary arterial hypertension associated with systemic sclerosis (PAH-SSc) are only partially validated. The aim of the present study was to establish an expert consensus regarding which outcome measures are most appropriate for clinical trials in PAH-SSc. Methods. Sixty-nine PAH-SSc experts (rheumatologists, cardiologists, pulmonologists) rated a list of disease domains and measurement tools in an Internet-based 3-stage Delphi consensus study. In stages 2 and 3, the medians of domains and measurement tools and frequency distributions of ratings, along with requests for re-ratings, were distributed to respondents to provide feedback. A final score of items was identified by means of cluster analysis. Results. The experts judged the following domains and tools as most appropriate for randomized controlled trials in PAH-SSc: lung vascular/pulmonary arterial pressure and cardiac function both measured by right heart catheterization and echocardiography, exercise testing measured by 6-minute walking test and oxygen saturation at exercise, severity of dyspnea measured on a visual analog scale, discontinuation of treatment measured by (serious) adverse events, quality of life/activities of daily living measured by the Short Form 36 and Health Assessment Questionnaire disability index, and global state assessed by physician measured by survival. Conclusion. Among experts in PAH-SSc, a core set of outcome measures has been defined for clinical trials by Delphi consensus methods. Although these outcome measures are recommended by this expert group to be used as an interim tool, it will be necessary to formally validate the present measures, as well as potential research measures, in further studies.
Affiliations:
- Allemagne, Australie, France, Italie, Royaume-Uni, Suisse, États-Unis
- Angleterre, Berlin, Californie, District de Darmstadt, District de Dresde, Grand Londres, Hesse (Land), Saxe (Land)
- Berlin, Dresde, Francfort-sur-le-Main, Londres, Los Angeles, San Diego
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Denton</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Royal Free and University College Medical School</s1><s2>London</s2><s3>GBR</s3><sZ>5 aut.</sZ></inist:fA14><country>Royaume-Uni</country><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="Foeldvari, Ivan" sort="Foeldvari, Ivan" uniqKey="Foeldvari I" first="Ivan" last="Foeldvari">Ivan Foeldvari</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>General Hospital Eilbek</s1><s2>Eilbek</s2><s3>DEU</s3><sZ>6 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Eilbek</wicri:noRegion><wicri:noRegion>General Hospital Eilbek</wicri:noRegion><wicri:noRegion>General Hospital Eilbek</wicri:noRegion></affiliation></author><author><name sortKey="Humbert, Marc" sort="Humbert, Marc" uniqKey="Humbert M" first="Marc" last="Humbert">Marc Humbert</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Hôpital Antoine Beclere, Assistance Publique Hôpitaux de Paris, and Université Paris Sud 11 Clamard</s1><s3>FRA</s3><sZ>7 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>and Université Paris Sud 11 Clamard</wicri:noRegion><wicri:noRegion>Hôpital Antoine Beclere, Assistance Publique Hôpitaux de Paris, and Université Paris Sud 11 Clamard</wicri:noRegion></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"><inist:fA14 i1="08"><s1>University of Florence</s1><s2>Florence</s2><s3>ITA</s3><sZ>8 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>University of Florence</wicri:noRegion></affiliation></author><author><name sortKey="Nash, Peter" sort="Nash, Peter" uniqKey="Nash P" first="Peter" last="Nash">Peter Nash</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>University of Queensland</s1><s2>Queensland</s2><s3>AUS</s3><sZ>9 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>University of Queensland</wicri:noRegion></affiliation></author><author><name sortKey="Opitz, Christian F" sort="Opitz, Christian F" uniqKey="Opitz C" first="Christian F." last="Opitz">Christian F. Opitz</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>DRK-Kliniken Berlin, Westend</s1><s2>Berlin</s2><s3>DEU</s3><sZ>10 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Rubin, Lewis J" sort="Rubin, Lewis J" uniqKey="Rubin L" first="Lewis J." last="Rubin">Lewis J. Rubin</name><affiliation wicri:level="3"><inist:fA14 i1="11"><s1>University of California</s1><s2>San Diego</s2><s3>USA</s3><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">San Diego</settlement><region type="state">Californie</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="1"><inist:fA14 i1="12"><s1>University of Michigan scleroderma Program</s1><s2>Ann Arbor</s2><s3>USA</s3><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>University of Michigan scleroderma Program</wicri:noRegion></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"><inist:fA14 i1="13"><s1>David Geffen School at University of California</s1><s2>Los Angeles</s2><s3>USA</s3><sZ>13 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Los Angeles</settlement><region type="state">Californie</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">08-0330192</idno><date when="2008">2008</date><idno type="stanalyst">PASCAL 08-0330192 INIST</idno><idno type="RBID">Pascal:08-0330192</idno><idno type="wicri:Area/PascalFrancis/Corpus">003438</idno><idno type="wicri:Area/PascalFrancis/Curation">002C11</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">003322</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">003322</idno><idno type="wicri:doubleKey">0893-7524:2008:Distler O:defining:appropriate:outcome</idno><idno type="wicri:Area/Main/Merge">009736</idno><idno type="wicri:Area/Main/Curation">008E03</idno><idno type="wicri:Area/Main/Exploration">008E03</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Defining Appropriate Outcome Measures in Pulmonary Arterial Hypertension Related to Systemic Sclerosis : A Delphi Consensus Study With Cluster Analysis</title><author><name sortKey="Distler, Oliver" sort="Distler, Oliver" uniqKey="Distler O" first="Oliver" last="Distler">Oliver Distler</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>University Hospital Zurich</s1><s2>Zurich</s2><s3>CHE</s3><sZ>1 aut.</sZ></inist:fA14><country>Suisse</country><wicri:noRegion>University Hospital Zurich</wicri:noRegion></affiliation></author><author><name sortKey="Behrens, Frank" sort="Behrens, Frank" uniqKey="Behrens F" first="Frank" last="Behrens">Frank Behrens</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>J. W. Goethe Univeristy</s1><s2>Frankfurt</s2><s3>DEU</s3><sZ>2 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region><settlement type="city">Francfort-sur-le-Main</settlement></placeName></affiliation></author><author><name sortKey="Pittrow, David" sort="Pittrow, David" uniqKey="Pittrow D" first="David" last="Pittrow">David Pittrow</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>University</s1><s2>Dresden</s2><s3>DEU</s3><sZ>3 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Saxe (Land)</region><region type="district" nuts="2">District de Dresde</region><settlement type="city">Dresde</settlement></placeName></affiliation></author><author><name sortKey="Huscher, Doerte" sort="Huscher, Doerte" uniqKey="Huscher D" first="Doerte" last="Huscher">Doerte Huscher</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>German Rhenmatism Research Centre</s1><s2>Berlin</s2><s3>DEU</s3><sZ>4 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</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"><inist:fA14 i1="05"><s1>Royal Free and University College Medical School</s1><s2>London</s2><s3>GBR</s3><sZ>5 aut.</sZ></inist:fA14><country>Royaume-Uni</country><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="Foeldvari, Ivan" sort="Foeldvari, Ivan" uniqKey="Foeldvari I" first="Ivan" last="Foeldvari">Ivan Foeldvari</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>General Hospital Eilbek</s1><s2>Eilbek</s2><s3>DEU</s3><sZ>6 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Eilbek</wicri:noRegion><wicri:noRegion>General Hospital Eilbek</wicri:noRegion><wicri:noRegion>General Hospital Eilbek</wicri:noRegion></affiliation></author><author><name sortKey="Humbert, Marc" sort="Humbert, Marc" uniqKey="Humbert M" first="Marc" last="Humbert">Marc Humbert</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Hôpital Antoine Beclere, Assistance Publique Hôpitaux de Paris, and Université Paris Sud 11 Clamard</s1><s3>FRA</s3><sZ>7 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>and Université Paris Sud 11 Clamard</wicri:noRegion><wicri:noRegion>Hôpital Antoine Beclere, Assistance Publique Hôpitaux de Paris, and Université Paris Sud 11 Clamard</wicri:noRegion></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"><inist:fA14 i1="08"><s1>University of Florence</s1><s2>Florence</s2><s3>ITA</s3><sZ>8 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>University of Florence</wicri:noRegion></affiliation></author><author><name sortKey="Nash, Peter" sort="Nash, Peter" uniqKey="Nash P" first="Peter" last="Nash">Peter Nash</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>University of Queensland</s1><s2>Queensland</s2><s3>AUS</s3><sZ>9 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>University of Queensland</wicri:noRegion></affiliation></author><author><name sortKey="Opitz, Christian F" sort="Opitz, Christian F" uniqKey="Opitz C" first="Christian F." last="Opitz">Christian F. Opitz</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>DRK-Kliniken Berlin, Westend</s1><s2>Berlin</s2><s3>DEU</s3><sZ>10 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Rubin, Lewis J" sort="Rubin, Lewis J" uniqKey="Rubin L" first="Lewis J." last="Rubin">Lewis J. Rubin</name><affiliation wicri:level="3"><inist:fA14 i1="11"><s1>University of California</s1><s2>San Diego</s2><s3>USA</s3><sZ>11 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">San Diego</settlement><region type="state">Californie</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="1"><inist:fA14 i1="12"><s1>University of Michigan scleroderma Program</s1><s2>Ann Arbor</s2><s3>USA</s3><sZ>12 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>University of Michigan scleroderma Program</wicri:noRegion></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"><inist:fA14 i1="13"><s1>David Geffen School at University of California</s1><s2>Los Angeles</s2><s3>USA</s3><sZ>13 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Los Angeles</settlement><region type="state">Californie</region></placeName></affiliation></author></analytic><series><title level="j" type="main">Arthritis care and research</title><title level="j" type="abbreviated">Arthritis care res.</title><idno type="ISSN">0893-7524</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Arthritis care and research</title><title level="j" type="abbreviated">Arthritis care res.</title><idno type="ISSN">0893-7524</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Artery</term><term>Prognosis</term><term>Pulmonary hypertension</term><term>Rheumatology</term><term>Scleroderma</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Pronostic</term><term>Hypertension artérielle pulmonaire</term><term>Artère</term><term>Sclérodermie</term><term>Rhumatologie</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Objective. Outcome measures for pulmonary arterial hypertension associated with systemic sclerosis (PAH-SSc) are only partially validated. The aim of the present study was to establish an expert consensus regarding which outcome measures are most appropriate for clinical trials in PAH-SSc. Methods. Sixty-nine PAH-SSc experts (rheumatologists, cardiologists, pulmonologists) rated a list of disease domains and measurement tools in an Internet-based 3-stage Delphi consensus study. In stages 2 and 3, the medians of domains and measurement tools and frequency distributions of ratings, along with requests for re-ratings, were distributed to respondents to provide feedback. A final score of items was identified by means of cluster analysis. Results. The experts judged the following domains and tools as most appropriate for randomized controlled trials in PAH-SSc: lung vascular/pulmonary arterial pressure and cardiac function both measured by right heart catheterization and echocardiography, exercise testing measured by 6-minute walking test and oxygen saturation at exercise, severity of dyspnea measured on a visual analog scale, discontinuation of treatment measured by (serious) adverse events, quality of life/activities of daily living measured by the Short Form 36 and Health Assessment Questionnaire disability index, and global state assessed by physician measured by survival. Conclusion. Among experts in PAH-SSc, a core set of outcome measures has been defined for clinical trials by Delphi consensus methods. Although these outcome measures are recommended by this expert group to be used as an interim tool, it will be necessary to formally validate the present measures, as well as potential research measures, in further studies.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>France</li><li>Italie</li><li>Royaume-Uni</li><li>Suisse</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Berlin</li><li>Californie</li><li>District de Darmstadt</li><li>District de Dresde</li><li>Grand Londres</li><li>Hesse (Land)</li><li>Saxe (Land)</li></region><settlement><li>Berlin</li><li>Dresde</li><li>Francfort-sur-le-Main</li><li>Londres</li><li>Los Angeles</li><li>San Diego</li></settlement></list><tree><country name="Suisse"><noRegion><name sortKey="Distler, Oliver" sort="Distler, Oliver" uniqKey="Distler O" first="Oliver" last="Distler">Oliver Distler</name></noRegion></country><country name="Allemagne"><region name="Hesse (Land)"><name sortKey="Behrens, Frank" sort="Behrens, Frank" uniqKey="Behrens F" first="Frank" last="Behrens">Frank Behrens</name></region><name sortKey="Foeldvari, Ivan" sort="Foeldvari, Ivan" uniqKey="Foeldvari I" first="Ivan" last="Foeldvari">Ivan Foeldvari</name><name sortKey="Huscher, Doerte" sort="Huscher, Doerte" uniqKey="Huscher D" first="Doerte" last="Huscher">Doerte Huscher</name><name sortKey="Opitz, Christian F" sort="Opitz, Christian F" uniqKey="Opitz C" first="Christian F." last="Opitz">Christian F. Opitz</name><name sortKey="Pittrow, David" sort="Pittrow, David" uniqKey="Pittrow D" first="David" last="Pittrow">David Pittrow</name></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Denton, Christopher P" sort="Denton, Christopher P" uniqKey="Denton C" first="Christopher P." last="Denton">Christopher P. Denton</name></region></country><country name="France"><noRegion><name sortKey="Humbert, Marc" sort="Humbert, Marc" uniqKey="Humbert M" first="Marc" last="Humbert">Marc Humbert</name></noRegion></country><country name="Italie"><noRegion><name sortKey="Matucci Cerinic, Marco" sort="Matucci Cerinic, Marco" uniqKey="Matucci Cerinic M" first="Marco" last="Matucci-Cerinic">Marco Matucci-Cerinic</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Nash, Peter" sort="Nash, Peter" uniqKey="Nash P" first="Peter" last="Nash">Peter Nash</name></noRegion></country><country name="États-Unis"><region name="Californie"><name sortKey="Rubin, Lewis J" sort="Rubin, Lewis J" uniqKey="Rubin L" first="Lewis J." last="Rubin">Lewis J. Rubin</name></region><name sortKey="Furst, Daniel E" sort="Furst, Daniel E" uniqKey="Furst D" first="Daniel E." last="Furst">Daniel E. Furst</name><name sortKey="Seibold, James R" sort="Seibold, James R" uniqKey="Seibold J" first="James R." last="Seibold">James R. Seibold</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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