Development of a provisional core set of response measures for clinical trials of systemic sclerosis
Objective:To develop a provisional core set of response measures for clinical trials of systemic sclerosis (SSc).Methods:The Scleroderma Clinical Trials Consortium (SCTC) conducted a structured, 3-round Delphi exercise to reach consensus on a core set of measures for clinical trials of SSc. Round 1...
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| Published in | Annals of the rheumatic diseases Vol. 67; no. 5; pp. 703 - 709 |
|---|---|
| Main Authors | , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
London
BMJ Publishing Group Ltd and European League Against Rheumatism
01.05.2008
BMJ Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0003-4967 1468-2060 1468-2060 |
| DOI | 10.1136/ard.2007.078923 |
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| Abstract | Objective:To develop a provisional core set of response measures for clinical trials of systemic sclerosis (SSc).Methods:The Scleroderma Clinical Trials Consortium (SCTC) conducted a structured, 3-round Delphi exercise to reach consensus on a core set of measures for clinical trials of SSc. Round 1 asked the SCTC investigators to list items in 11 pre-defined domains (skin, musculoskeletal, cardiac, pulmonary, cardio-pulmonary, gastrointestinal, renal, Raynaud phenomenon and digital ulcers, health-related quality of life and function, global health, and biomarkers) for SSc clinical trials. Round 2 asked respondents to rate the importance of the chosen items and was followed by a meeting, during which the Steering Committee discussed the feasibility, reliability, redundancy and validity of the items. Round 3 sought to obtain broader consensus on the core set measures. Members also voted on items that had data on feasibility but lacked data on reliability and validity, but may still be useful research outcome measures for future trials.Results:A total of 50 SCTC investigators participated in round 1, providing 212 unique items for the 11 domains. In all, 46 (92%) participants responded in round 2 and rated 177 items. The ratings of 177 items were reviewed by the Steering Committee and 31 items from the 11 domains were judged to be appropriate for inclusion in a 1-year multi-centre clinical trial. In total, 40 SCTC investigators completed round 3 and ranked 30 of 31 items as acceptable for inclusion in the core set. The Steering Committee also proposed 14 items for a research agenda.Conclusion:Using a Delphi exercise, we have developed a provisional core set of measures for assessment of disease activity and severity in clinical trials of SSc. |
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| AbstractList | To develop a provisional core set of response measures for clinical trials of systemic sclerosis (SSc).OBJECTIVETo develop a provisional core set of response measures for clinical trials of systemic sclerosis (SSc).The Scleroderma Clinical Trials Consortium (SCTC) conducted a structured, 3-round Delphi exercise to reach consensus on a core set of measures for clinical trials of SSc. Round 1 asked the SCTC investigators to list items in 11 pre-defined domains (skin, musculoskeletal, cardiac, pulmonary, cardio-pulmonary, gastrointestinal, renal, Raynaud phenomenon and digital ulcers, health-related quality of life and function, global health, and biomarkers) for SSc clinical trials. Round 2 asked respondents to rate the importance of the chosen items and was followed by a meeting, during which the Steering Committee discussed the feasibility, reliability, redundancy and validity of the items. Round 3 sought to obtain broader consensus on the core set measures. Members also voted on items that had data on feasibility but lacked data on reliability and validity, but may still be useful research outcome measures for future trials.METHODSThe Scleroderma Clinical Trials Consortium (SCTC) conducted a structured, 3-round Delphi exercise to reach consensus on a core set of measures for clinical trials of SSc. Round 1 asked the SCTC investigators to list items in 11 pre-defined domains (skin, musculoskeletal, cardiac, pulmonary, cardio-pulmonary, gastrointestinal, renal, Raynaud phenomenon and digital ulcers, health-related quality of life and function, global health, and biomarkers) for SSc clinical trials. Round 2 asked respondents to rate the importance of the chosen items and was followed by a meeting, during which the Steering Committee discussed the feasibility, reliability, redundancy and validity of the items. Round 3 sought to obtain broader consensus on the core set measures. Members also voted on items that had data on feasibility but lacked data on reliability and validity, but may still be useful research outcome measures for future trials.A total of 50 SCTC investigators participated in round 1, providing 212 unique items for the 11 domains. In all, 46 (92%) participants responded in round 2 and rated 177 items. The ratings of 177 items were reviewed by the Steering Committee and 31 items from the 11 domains were judged to be appropriate for inclusion in a 1-year multi-centre clinical trial. In total, 40 SCTC investigators completed round 3 and ranked 30 of 31 items as acceptable for inclusion in the core set. The Steering Committee also proposed 14 items for a research agenda.RESULTSA total of 50 SCTC investigators participated in round 1, providing 212 unique items for the 11 domains. In all, 46 (92%) participants responded in round 2 and rated 177 items. The ratings of 177 items were reviewed by the Steering Committee and 31 items from the 11 domains were judged to be appropriate for inclusion in a 1-year multi-centre clinical trial. In total, 40 SCTC investigators completed round 3 and ranked 30 of 31 items as acceptable for inclusion in the core set. The Steering Committee also proposed 14 items for a research agenda.Using a Delphi exercise, we have developed a provisional core set of measures for assessment of disease activity and severity in clinical trials of SSc.CONCLUSIONUsing a Delphi exercise, we have developed a provisional core set of measures for assessment of disease activity and severity in clinical trials of SSc. Objective: To develop a provisional core set of response measures for clinical trials of systemic sclerosis (SSc). Methods: The Scleroderma Clinical Trials Consortium (SCTC) conducted a structured, 3-round Delphi exercise to reach consensus on a core set of measures for clinical trials of SSc. Round 1 asked the SCTC investigators to list items in 11 pre-defined domains (skin, musculoskeletal, cardiac, pulmonary, cardio-pulmonary, gastrointestinal, renal, Raynaud phenomenon and digital ulcers, health-related quality of life and function, global health, and biomarkers) for SSc clinical trials. Round 2 asked respondents to rate the importance of the chosen items and was followed by a meeting, during which the Steering Committee discussed the feasibility, reliability, redundancy and validity of the items. Round 3 sought to obtain broader consensus on the core set measures. Members also voted on items that had data on feasibility but lacked data on reliability and validity, but may still be useful research outcome measures for future trials. Results: A total of 50 SCTC investigators participated in round 1, providing 212 unique items for the 11 domains. In all, 46 (92%) participants responded in round 2 and rated 177 items. The ratings of 177 items were reviewed by the Steering Committee and 31 items from the 11 domains were judged to be appropriate for inclusion in a 1-year multi-centre clinical trial. In total, 40 SCTC investigators completed round 3 and ranked 30 of 31 items as acceptable for inclusion in the core set. The Steering Committee also proposed 14 items for a research agenda. Conclusion: Using a Delphi exercise, we have developed a provisional core set of measures for assessment of disease activity and severity in clinical trials of SSc. To develop a provisional core set of response measures for clinical trials of systemic sclerosis (SSc). The Scleroderma Clinical Trials Consortium (SCTC) conducted a structured, 3-round Delphi exercise to reach consensus on a core set of measures for clinical trials of SSc. Round 1 asked the SCTC investigators to list items in 11 pre-defined domains (skin, musculoskeletal, cardiac, pulmonary, cardio-pulmonary, gastrointestinal, renal, Raynaud phenomenon and digital ulcers, health-related quality of life and function, global health, and biomarkers) for SSc clinical trials. Round 2 asked respondents to rate the importance of the chosen items and was followed by a meeting, during which the Steering Committee discussed the feasibility, reliability, redundancy and validity of the items. Round 3 sought to obtain broader consensus on the core set measures. Members also voted on items that had data on feasibility but lacked data on reliability and validity, but may still be useful research outcome measures for future trials. A total of 50 SCTC investigators participated in round 1, providing 212 unique items for the 11 domains. In all, 46 (92%) participants responded in round 2 and rated 177 items. The ratings of 177 items were reviewed by the Steering Committee and 31 items from the 11 domains were judged to be appropriate for inclusion in a 1-year multi-centre clinical trial. In total, 40 SCTC investigators completed round 3 and ranked 30 of 31 items as acceptable for inclusion in the core set. The Steering Committee also proposed 14 items for a research agenda. Using a Delphi exercise, we have developed a provisional core set of measures for assessment of disease activity and severity in clinical trials of SSc. |
| Author | Khanna, D Merkel, P A Clements, P J Seibold, J R Denton, C P Matucci-Cerinic, M Steen, V D Varga, J Giannini, E Mayes, M D Furst, D E Lovell, D J |
| AuthorAffiliation | 7 Division of Rheumatology and Clinical Immunogenetics, The University of Texas Houston Medical School, Houston, Texas, USA 8 Division of Rheumatology, Georgetown University Medical Center, Washington DC, USA 5 University of Florence, Florence, Italy 1 Division of Rheumatology, Department of Medicine, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California, USA 2 Division of Rheumatology, Cincinnati Children’s Medical Center, Cincinnati, Ohio, USA 6 Royal Free Hospital, London, UK 9 Division of Rheumatology, Northwestern University Medical School, Chicago, Illinois, USA 4 University of Michigan Scleroderma Program, Ann Arbor, Michigan, USA 3 Section of Rheumatology and the Clinical Epidemiology Unit, Boston University School of Medicine, Boston, Massachusetts, USA |
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| ContentType | Journal Article |
| Contributor | Mayes, Maureen D Doyle, Mittie Kelleher Buch, Maya H Wollheim, Frank A Csuka, Mary Ellen Voskuyl, Alexander E Johnson, Sindhu Collier, David Veale, Douglas Gran, Jan Tore Furst, Daniel E Berezne, Alice Brühlmann, Pius Lovell, Daniel E Derk, Chris T Lafyatis, Robert A Farge-Bancel, Domonique Grau, Raffael Martin, Richard W Inanç, Murat Malcarne, Vanessa van den Hoogen, Frank H J Crofford, Leslie Wigley, Fred Matucci-Cerinic, Marco Sweiss, Nadera Rich, Eric Goldberg, Avram Rothfield, Naomi F McKown, Kevin Khanna, Dinesh Strand, Vibeke Scorza, Raffaella Simms, Robert W McHugh, Neil J Schiopu, Elena Briet, Samuel N Shanahan, Joseph Denton, Christopher P Silver, Richard M Merkel, Peter A Hayat, Samina Kahaleh, M Bashar Catoggio, Luis Hsu, Vivien Valentini, Gabriele Czirják, László Fessler, Barri Lee, Peter Clements, Philip J Distler, Oliver Giannini, Edward Mahmud, Tafazzul H Hummers, Laura K Medsger, Jr, Thomas A Steen, Virginia D Baron, Murray Griffing, W Leroy Senécal, Jean-Luc Pope, Janet E Foeldvari, Ivan Herrick, Ariane L Seibold, James R Morelan |
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| Copyright | 2008 BMJ Publishing Group and European League Against Rheumatism 2008 INIST-CNRS Copyright: 2008 2008 BMJ Publishing Group and European League Against Rheumatism |
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| DOI | 10.1136/ard.2007.078923 |
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| Keywords | Immunopathology Connective tissue disease Skin disease Systemic disease Rheumatology Autoimmune disease Clinical trial Scleroderma |
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| References | Merkel, Silliman, Clements, Denton, Furst, Mayes 2005; 52 Merkel, Herlyn, Martin, Anderson, Mayes, Bell 2002; 46 Denton, Merkel, Furst, Khanna, Emery, Hsu 2006; 56 Ruperto, Ravelli, Oliveira, Alessio, Mihaylova, Pasic 2006; 55 Khanna, Merkel 2007 White, Bauer, Goldsmith, Hochberg, Katz, Korn 1995; 38 Grant, Aitchison, Henderson, Christie, Zare, McMurray 1999; 116 Charles, Clements, Furst 2006; 367 Hoyles, Ellis, Wellsbury, Lees, Newlands, Goh 2006; 206 Khanna, Ahmed, Furst, Ginsburg, Park, Hornung 2007; 57 Khanna 2006; 3 Felson, Anderson, Boers, Bombardier, Chernoff, Fried 1993; 36 Hsu, Shinnar, Moreyra, Shindler, Wilson, Wilson 2004; 50 Furst, Khanna, Matucci-Cerinic, Silman, Merkel, Foeldvari 2005; 32 Boers, Brooks, Strand, Tugwell 1998; 25 Khanna, Furst, Wong, Tsevat, Clements, Park 2007; 16 Kissin, Schiller, Gelbard, Anderson, Falanga, Simms 2006; 55 Merkel, Clements, Reveille, Suarez-Almazor, Valentini, Furst 2003; 30 Tashkin, Elashoff, Clements, Goldin, Roth, Furst 2006; 354 Furst, Khanna, Matucci-Cerinic, Clements, Steen, Pope 2007; 34 Pfennings, Cohen, van der 1995; 77 Felson, Anderson, Boers, Bombardier, Furst, Goldsmith 1995; 38 Fries, Spitz, Kraines, Holman 1980; 23 Felson 1993; 20 Wigley, Korn, Csuka, Medsger, Rothfield, Ellman 1998; 41 Merkel, Silliman, Denton, Clements, Emery P et 2004; 50 Impens, Chung, Buch, Schiopu, Kotsis, Burns 2006; 54 Khanna, Furst, Clements, Park, Hays, Yoon 2005; 32 Guyatt, Townsend, Berman, Keller 1987; 40 Buch, Denton, Furst, Guillevin, Rubin, Wells Khanna, Furst, Hays, Park, Wong, Seibold 2006; 65 Medsger, Silman, Steen, Black, Akesson, Bacon 1999; 26 Khanna, Hays, Park, Braun-Moscovici, Mayes, McNearney 2007; 57 Sterz, McCloskey, Clements, Furst 2004 Varga 2002; 46 Williams, Handler, Akram, Smith, Das, Smee 2006; 26 Wigley, Hummers, Clements, Furst 2004 Fries, Shariat, von Wilmowsky, Bohm 2005; 112 Lederer, Arcasoy, Wilt, D’Ovidio, Sonett, Kawut 2006; 174 Steen, Medsger 1997; 40 Altman, Medsger, Bloch, Michel 1991; 34 Giannini, Ruperto, Ravelli, Lovell, Felson, Martini 1997; 40 White (10.1136/ard.2007.078923_bib4) 1995; 38 Wigley (10.1136/ard.2007.078923_bib33) 2004 Felson (10.1136/ard.2007.078923_bib12) 1995; 38 Steen (10.1136/ard.2007.078923_bib23) 1997; 40 Khanna (10.1136/ard.2007.078923_bib2) 2007; 57 Sterz (10.1136/ard.2007.078923_bib32) 2004 Pfennings (10.1136/ard.2007.078923_bib43) 1995; 77 Boers (10.1136/ard.2007.078923_bib15) 1998; 25 Guyatt (10.1136/ard.2007.078923_bib42) 1987; 40 Fries (10.1136/ard.2007.078923_bib24) 1980; 23 Furst (10.1136/ard.2007.078923_bib9) 2005; 32 Denton (10.1136/ard.2007.078923_bib7) 2006; 56 Lederer (10.1136/ard.2007.078923_bib36) 2006; 174 Tashkin (10.1136/ard.2007.078923_bib40) 2006; 354 Furst (10.1136/ard.2007.078923_bib8) 2007; 34 Khanna (10.1136/ard.2007.078923_bib21) 2007 Felson (10.1136/ard.2007.078923_bib30) 1993; 20 Altman (10.1136/ard.2007.078923_bib1) 1991; 34 Hoyles (10.1136/ard.2007.078923_bib41) 2006; 206 Ware (10.1136/ard.2007.078923_bib25) 2000 Giannini (10.1136/ard.2007.078923_bib13) 1997; 40 Ruperto (10.1136/ard.2007.078923_bib14) 2006; 55 Williams (10.1136/ard.2007.078923_bib27) 2006; 26 Buch (10.1136/ard.2007.078923_bib37) 2006 Hsu (10.1136/ard.2007.078923_bib46) 2004; 50 Merkel (10.1136/ard.2007.078923_bib10) 2003; 30 Delbecq (10.1136/ard.2007.078923_bib11) 1975 Impens (10.1136/ard.2007.078923_bib18) 2006; 54 Varga (10.1136/ard.2007.078923_bib6) 2002; 46 Khanna (10.1136/ard.2007.078923_bib28) 2007; 16 Felson (10.1136/ard.2007.078923_bib31) 1993; 36 Fries (10.1136/ard.2007.078923_bib35) 2005; 112 Charles (10.1136/ard.2007.078923_bib5) 2006; 367 Khanna (10.1136/ard.2007.078923_bib45) 2006; 65 Grant (10.1136/ard.2007.078923_bib44) 1999; 116 Merkel (10.1136/ard.2007.078923_bib26) 2002; 46 Khanna (10.1136/ard.2007.078923_bib17) 2005; 32 Merkel (10.1136/ard.2007.078923_bib39) 2004; 50 Merkel (10.1136/ard.2007.078923_bib22) 2005; 52 Medsger (10.1136/ard.2007.078923_bib29) 1999; 26 Khanna (10.1136/ard.2007.078923_bib34) 2006; 3 Kissin (10.1136/ard.2007.078923_bib16) 2006; 55 Furst (10.1136/ard.2007.078923_bib19) 2007; 34 Brook (10.1136/ard.2007.078923_bib20) 1994 Wigley (10.1136/ard.2007.078923_bib38) 1998; 41 Khanna (10.1136/ard.2007.078923_bib3) 2007; 57 |
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| Snippet | Objective:To develop a provisional core set of response measures for clinical trials of systemic sclerosis (SSc).Methods:The Scleroderma Clinical Trials... Objective: To develop a provisional core set of response measures for clinical trials of systemic sclerosis (SSc). Methods: The Scleroderma Clinical Trials... To develop a provisional core set of response measures for clinical trials of systemic sclerosis (SSc). The Scleroderma Clinical Trials Consortium (SCTC)... To develop a provisional core set of response measures for clinical trials of systemic sclerosis (SSc).OBJECTIVETo develop a provisional core set of response... |
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| SubjectTerms | Biological and medical sciences Clinical trials Clinical Trials as Topic Colleges & universities Consensus Delphi Technique Diseases of the osteoarticular system Endpoint Determination Hospitals Humans Medical sciences Medicine Mortality Multicenter Studies as Topic Quality of life Questionnaires Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis Scleroderma Scleroderma, Systemic - therapy Treatment Outcome Validity |
| Title | Development of a provisional core set of response measures for clinical trials of systemic sclerosis |
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