Minimally important difference in diffuse systemic sclerosis: results from the d-penicillamine study
Objective: To estimate minimally important differences (MIDs) in scores for the modified Rodnan Skin Score (mRSS) and Health Assessment Questionnaire—Disability Index (HAQ-DI) in a clinical trial on diffuse systemic sclerosis (SSc). Participants and methods: 134 people participated in a 2-year, doub...
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| Published in | Annals of the rheumatic diseases Vol. 65; no. 10; pp. 1325 - 1329 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
London
BMJ Publishing Group Ltd and European League Against Rheumatism
01.10.2006
BMJ Elsevier Limited BMJ Group |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0003-4967 1468-2060 |
| DOI | 10.1136/ard.2005.050187 |
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| Abstract | Objective: To estimate minimally important differences (MIDs) in scores for the modified Rodnan Skin Score (mRSS) and Health Assessment Questionnaire—Disability Index (HAQ-DI) in a clinical trial on diffuse systemic sclerosis (SSc). Participants and methods: 134 people participated in a 2-year, double-blind, randomised clinical trial comparing efficacy of low-dose and high-dose d-penicillamine in diffuse SSc. At 6, 12, 18 and 24 months, the investigator was asked to rate the change in the patient’s health since entering the study: markedly worsened, moderately worsened, slightly worsened, unchanged, slightly improved, moderately improved or markedly improved. Patients who were rated as slightly improved were defined as the minimally changed subgroup and compared with patients rated as moderately or markedly improved. Results: The MID estimates for the mRSS improvement ranged from 3.2 to 5.3 (0.40–0.66 effect size) and for the HAQ-DI from 0.10 to 0.14 (0.15–0.21 effect size). Patients who were rated to improve more than slightly were found to improve by 6.9–14.2 (0.86–1.77 effect size) on the mRSS and 0.21–0.55 (0.32–0.83 effect size) on the HAQ-DI score. Conclusion: MID estimates are provided for improvement in the mRSS and HAQ-DI scores, which can help in interpreting clinical trials on patients with SSc and be used for sample size calculation for future clinical trials on diffuse SSc. |
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| AbstractList | Objective: To estimate minimally important differences (MIDs) in scores for the modified Rodnan Skin Score (mRSS) and Health Assessment Questionnaire—Disability Index (HAQ-DI) in a clinical trial on diffuse systemic sclerosis (SSc). Participants and methods: 134 people participated in a 2-year, double-blind, randomised clinical trial comparing efficacy of low-dose and high-dose d-penicillamine in diffuse SSc. At 6, 12, 18 and 24 months, the investigator was asked to rate the change in the patient’s health since entering the study: markedly worsened, moderately worsened, slightly worsened, unchanged, slightly improved, moderately improved or markedly improved. Patients who were rated as slightly improved were defined as the minimally changed subgroup and compared with patients rated as moderately or markedly improved. Results: The MID estimates for the mRSS improvement ranged from 3.2 to 5.3 (0.40–0.66 effect size) and for the HAQ-DI from 0.10 to 0.14 (0.15–0.21 effect size). Patients who were rated to improve more than slightly were found to improve by 6.9–14.2 (0.86–1.77 effect size) on the mRSS and 0.21–0.55 (0.32–0.83 effect size) on the HAQ-DI score. Conclusion: MID estimates are provided for improvement in the mRSS and HAQ-DI scores, which can help in interpreting clinical trials on patients with SSc and be used for sample size calculation for future clinical trials on diffuse SSc. To estimate minimally important differences (MIDs) in scores for the modified Rodnan Skin Score (mRSS) and Health Assessment Questionnaire-Disability Index (HAQ-DI) in a clinical trial on diffuse systemic sclerosis (SSc). 134 people participated in a 2-year, double-blind, randomised clinical trial comparing efficacy of low-dose and high-dose D-penicillamine in diffuse SSc. At 6, 12, 18 and 24 months, the investigator was asked to rate the change in the patient's health since entering the study: markedly worsened, moderately worsened, slightly worsened, unchanged, slightly improved, moderately improved or markedly improved. Patients who were rated as slightly improved were defined as the minimally changed subgroup and compared with patients rated as moderately or markedly improved. The MID estimates for the mRSS improvement ranged from 3.2 to 5.3 (0.40-0.66 effect size) and for the HAQ-DI from 0.10 to 0.14 (0.15-0.21 effect size). Patients who were rated to improve more than slightly were found to improve by 6.9-14.2 (0.86-1.77 effect size) on the mRSS and 0.21-0.55 (0.32-0.83 effect size) on the HAQ-DI score. MID estimates are provided for improvement in the mRSS and HAQ-DI scores, which can help in interpreting clinical trials on patients with SSc and be used for sample size calculation for future clinical trials on diffuse SSc. To estimate minimally important differences (MIDs) in scores for the modified Rodnan Skin Score (mRSS) and Health Assessment Questionnaire-Disability Index (HAQ-DI) in a clinical trial on diffuse systemic sclerosis (SSc).OBJECTIVETo estimate minimally important differences (MIDs) in scores for the modified Rodnan Skin Score (mRSS) and Health Assessment Questionnaire-Disability Index (HAQ-DI) in a clinical trial on diffuse systemic sclerosis (SSc).134 people participated in a 2-year, double-blind, randomised clinical trial comparing efficacy of low-dose and high-dose D-penicillamine in diffuse SSc. At 6, 12, 18 and 24 months, the investigator was asked to rate the change in the patient's health since entering the study: markedly worsened, moderately worsened, slightly worsened, unchanged, slightly improved, moderately improved or markedly improved. Patients who were rated as slightly improved were defined as the minimally changed subgroup and compared with patients rated as moderately or markedly improved.PARTICIPANTS AND METHODS134 people participated in a 2-year, double-blind, randomised clinical trial comparing efficacy of low-dose and high-dose D-penicillamine in diffuse SSc. At 6, 12, 18 and 24 months, the investigator was asked to rate the change in the patient's health since entering the study: markedly worsened, moderately worsened, slightly worsened, unchanged, slightly improved, moderately improved or markedly improved. Patients who were rated as slightly improved were defined as the minimally changed subgroup and compared with patients rated as moderately or markedly improved.The MID estimates for the mRSS improvement ranged from 3.2 to 5.3 (0.40-0.66 effect size) and for the HAQ-DI from 0.10 to 0.14 (0.15-0.21 effect size). Patients who were rated to improve more than slightly were found to improve by 6.9-14.2 (0.86-1.77 effect size) on the mRSS and 0.21-0.55 (0.32-0.83 effect size) on the HAQ-DI score.RESULTSThe MID estimates for the mRSS improvement ranged from 3.2 to 5.3 (0.40-0.66 effect size) and for the HAQ-DI from 0.10 to 0.14 (0.15-0.21 effect size). Patients who were rated to improve more than slightly were found to improve by 6.9-14.2 (0.86-1.77 effect size) on the mRSS and 0.21-0.55 (0.32-0.83 effect size) on the HAQ-DI score.MID estimates are provided for improvement in the mRSS and HAQ-DI scores, which can help in interpreting clinical trials on patients with SSc and be used for sample size calculation for future clinical trials on diffuse SSc.CONCLUSIONMID estimates are provided for improvement in the mRSS and HAQ-DI scores, which can help in interpreting clinical trials on patients with SSc and be used for sample size calculation for future clinical trials on diffuse SSc. |
| Author | Khanna, D Seibold, J R Martin, R W Clements, P J Wigley, F F White, B Mayes, M D Andrews, B Furst, D E Wong, W K Moreland, L Weiner, S R Weisman, M Park, G S Lally, E V Hays, R D Collier, D Steen, V D Varga, J Barr, W Weinstein, A Abeles, M Medsger, T A |
| AuthorAffiliation | B Andrews , Division of Rheumatology, University of California, Irvine, California, USA F F Wigley , Rheumatology Division, The Johns Hopkins University, Baltimore, Maryland, USA V D Steen , A Weinstein , Division of Rheumatology, Georgetown University Medical Center, Washington, DC, USA D E Furst , G S Park , S R Weiner , P J Clements , Department of Medicine, Division of Rheumatology, David Geffen School of Medicine, Los Angeles, California, USA E V Lally , Division of Rheumatology, Brown Medical School, Providence, Rhode Island, USA J R Seibold , University of Michigan Scleroderma Program, Ann Arbor, Michigan, USA M Abeles , Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA R W Martin , Division of Rheumatology, College of Human Medicine, Michigan State University, Grand Rapids, Michigan, USA D Collier , Division of Rheumatology, University of Colorado Health Sciences Center, Denver, Colorado, USA W Barr , J Varga , Division of Rheumatology |
| AuthorAffiliation_xml | – name: G S Park , W K Wong , Department of Biostatistics, David Geffen School of Medicine – name: D Collier , Division of Rheumatology, University of Colorado Health Sciences Center, Denver, Colorado, USA – name: B White , Department of Rheumatology and Clinical Immunology, University of Maryland School of Medicine, Baltimore, Maryland, USA – name: B Andrews , Division of Rheumatology, University of California, Irvine, California, USA – name: D Khanna , Division of Immunology, Department of Medicine; Institute for the Study of Health, University of Cincinnati, Cincinnati, Ohio, USA; Veterans Affairs Medical Center, Cincinnati – name: R D Hays , Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine – name: V D Steen , A Weinstein , Division of Rheumatology, Georgetown University Medical Center, Washington, DC, USA – name: R W Martin , Division of Rheumatology, College of Human Medicine, Michigan State University, Grand Rapids, Michigan, USA – name: M Weisman , Division of Rheumatology, Cedars‐Sinai Medical Center, Los Angeles – name: E V Lally , Division of Rheumatology, Brown Medical School, Providence, Rhode Island, USA – name: W Barr , J Varga , Division of Rheumatology, Northwestern University Medical School, Chicago, Illinois, USA – name: T A Medsger Jr, , Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA – name: M D Mayes , Division of Rheumatology and Clinical Immunogenetics, The University of Texas—Houston Medical School, Houston, Texas, USA – name: L Moreland , Divison of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA – name: D E Furst , G S Park , S R Weiner , P J Clements , Department of Medicine, Division of Rheumatology, David Geffen School of Medicine, Los Angeles, California, USA – name: R D Hays , RAND, Los Angeles – name: J R Seibold , University of Michigan Scleroderma Program, Ann Arbor, Michigan, USA – name: M Abeles , Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – name: F F Wigley , Rheumatology Division, The Johns Hopkins University, Baltimore, Maryland, USA |
| Author_xml | – sequence: 1 givenname: D surname: Khanna fullname: Khanna, D organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 2 givenname: D E surname: Furst fullname: Furst, D E organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 3 givenname: R D surname: Hays fullname: Hays, R D organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 4 givenname: G S surname: Park fullname: Park, G S organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 5 givenname: W K surname: Wong fullname: Wong, W K organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 6 givenname: J R surname: Seibold fullname: Seibold, J R organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 7 givenname: M D surname: Mayes fullname: Mayes, M D organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 8 givenname: B surname: White fullname: White, B organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 9 givenname: F F surname: Wigley fullname: Wigley, F F organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 10 givenname: M surname: Weisman fullname: Weisman, M organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 11 givenname: W surname: Barr fullname: Barr, W organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 12 givenname: L surname: Moreland fullname: Moreland, L organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 13 givenname: T A surname: Medsger fullname: Medsger, T A organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 14 givenname: V D surname: Steen fullname: Steen, V D organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 15 givenname: R W surname: Martin fullname: Martin, R W organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 16 givenname: D surname: Collier fullname: Collier, D organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 17 givenname: A surname: Weinstein fullname: Weinstein, A organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 18 givenname: E V surname: Lally fullname: Lally, E V organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 19 givenname: J surname: Varga fullname: Varga, J organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 20 givenname: S R surname: Weiner fullname: Weiner, S R organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 21 givenname: B surname: Andrews fullname: Andrews, B organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 22 givenname: M surname: Abeles fullname: Abeles, M organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA – sequence: 23 givenname: P J surname: Clements fullname: Clements, P J organization: Division of Rheumatic Diseases, University of Connecticut Health Center, Farmington, Connecticut, USA |
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| Copyright | Copyright 2006 by Annals of the Rheumatic Diseases 2006 INIST-CNRS Copyright: 2006 Copyright 2006 by Annals of the Rheumatic Diseases Copyright © 2006 BMJ Publishing Group Ltd & European League Against Rheumatism |
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| Keywords | Sulfur containing aminoacid Diffuse Immunopathology Connective tissue disease Skin disease Systemic disease Rheumatology Chelating agent Autoimmune disease Antirheumatic agent Penicillamine Scleroderma |
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| Notes | href:annrheumdis-65-1325.pdf istex:EA993A9DCBA4589098C115D65BF87C88A7C8E6FC Correspondence to: D Khanna Division of Immunology, Department of Medicine, University of Cincinnati, ML 0563, Cincinnati, OH 45267-0563, USA;dinesh.khanna@uc.edu PMID:16540546 ark:/67375/NVC-R1XK399K-3 local:0651325 ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 ObjectType-Undefined-3 Copyright © 2006 BMJ Publishing Group Ltd & European League Against Rheumatism Current address: Amgen, Thousand Oaks, California, USA |
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| References_xml | – volume: 14 start-page: 1 year: 2000 ident: 10.1136/ard.2005.050187_bib11 article-title: Systemic sclerosis (scleroderma) and related disorders: clinical aspects publication-title: Baillieres Best Pract Res Clin Rheumatol doi: 10.1053/berh.1999.0074 – volume: 52 start-page: 717 year: 1999 ident: 10.1136/ard.2005.050187_bib4 article-title: Surveying physicians to determine the minimal important difference: implications for sample-size calculation publication-title: J Clin Epidemiol doi: 10.1016/S0895-4356(99)00050-5 – volume: 18 start-page: 419 year: 2000 ident: 10.1136/ard.2005.050187_bib5 article-title: The concept of clinically meaningful difference in health-related quality-of-life research. 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| Snippet | Objective: To estimate minimally important differences (MIDs) in scores for the modified Rodnan Skin Score (mRSS) and Health Assessment... To estimate minimally important differences (MIDs) in scores for the modified Rodnan Skin Score (mRSS) and Health Assessment Questionnaire-Disability Index... |
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| SubjectTerms | Adult Antirheumatic Agents - administration & dosage Antirheumatic Agents - therapeutic use Biological and medical sciences Bones, joints and connective tissue. Antiinflammatory agents Clinical trials d-Pen d-penicillamine Disability Evaluation Disease Diseases of the osteoarticular system Dose-Response Relationship, Drug Estimates Extended Report Female Follow-Up Studies HAQ-DI Health Assessment Questionnaire—Disability Index Health Status Indicators health-related quality of life HRQOL Humans Male Medical sciences MID Middle Aged minimally important difference modified Rodnan Skin Score mRSS Penicillamine - administration & dosage Penicillamine - therapeutic use Pharmacology. Drug treatments Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis Scleroderma, Diffuse - drug therapy Scleroderma, Diffuse - rehabilitation Severity of Illness Index Skin SSc systemic sclerosis Treatment Outcome |
| Title | Minimally important difference in diffuse systemic sclerosis: results from the d-penicillamine study |
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