Online citations, reference lists, and bibliographies.

The American College Of Rheumatology Preliminary Core Set Of Disease Activity Measures For Rheumatoid Arthritis Clinical Trials. The Committee On Outcome Measures In Rheumatoid Arthritis Clinical Trials.

D. Felson, J. Anderson, M. Boers, C. Bombardier, M. Chernoff, B. Fried, D. Furst, C. Goldsmith, S. Kieszak, R. Lightfoot
Published 1993 · Medicine
Cite This
Download PDF
Analyze on Scholarcy
Share
OBJECTIVE To develop a set of disease activity measures for use in rheumatoid arthritis (RA) clinical trials, as well as to recommend specific methods for assessing each outcome measure. This is not intended to be a restrictive list, but rather, a core set of measures that should be included in all trials. METHODS We evaluated disease activity measures commonly used in RA trials, to determine which measures best met each of 5 types of validity: construct, face, content, criterion, and discriminant. The evaluation consisted of an initial structured review of the literature on the validity of measures, with an analysis of data obtained from clinical trials to fill in gaps in this literature. A committee of experts in clinical trials, health services research, and biostatistics reviewed the validity data. A nominal group process method was used to reach consensus on a core set of disease activity measures. This set was then reviewed and finalized at an international conference on outcome measures for RA clinical trials. The committee also selected specific ways to assess each outcome. RESULTS The core set of disease activity measures consists of a tender joint count, swollen joint count, patient's assessment of pain, patient's and physician's global assessments of disease activity, patient's assessment of physical function, and laboratory evaluation of 1 acute-phase reactant. Together, these measures sample the broad range of improvement in RA (have content validity), and all are at least moderately sensitive to change (have discriminant validity). Many of them predict other important long-term outcomes in RA, including physical disability, radiographic damage, and death. Other disease activity measures frequently used in clinical trials were not chosen for any one of several reasons, including insensitivity to change or duplication of information provided by one of the core measures (e.g., tender joint score and tender joint count). The committee also proposes specific ways of measuring each outcome. CONCLUSION We propose a core set of outcome measures for RA clinical trials. We hope this will decrease the number of outcomes assessed and standardize outcomes assessments. Further, we hope that these measures will be found useful in long-term studies.



This paper is referenced by
10.1016/B978-1-4377-1893-5.00054-6
Chapter 54 – Critical Issues in Drug Development for SLE
Ronald F. van Vollenhoven (2013)
Réhabilitation conservatrice d'adultes atteints du syndrome d'hypermobilité
Rebecca Nyffeler (2014)
10.1161/HYPERTENSIONAHA.109.143982
Tumor Necrosis Factor-&agr; Antagonists Improve Aortic Stiffness in Patients With Inflammatory Arthropathies: A Controlled Study
Kristin Angel (2010)
10.1002/acr.22387
How much is fatigue explained by standard clinical characteristics of disease activity in patients with inflammatory arthritis? A longitudinal study.
Patricia Minnock (2014)
Scores for all seasons: SDAI and CDAI.
Josef S. Smolen (2014)
10.1016/B978-0-323-24145-8.00007-7
Chapter 7 – Assessment of Health Status, Function, and Quality of Life Outcomes
Ciarán M. Duffy (2016)
10.1016/j.semarthrit.2015.09.004
Indirect comparisons of the efficacy of biological agents in patients with psoriatic arthritis with an inadequate response to traditional disease-modifying anti-rheumatic drugs or to non-steroidal anti-inflammatory drugs: A meta-analysis.
Patompong Ungprasert (2016)
10.1136/bmjopen-2016-011174
Hand-related physical function in rheumatic hand conditions: a protocol for developing a patient-reported outcome measurement instrument
L. Klokker (2016)
10.1016/j.jtos.2016.08.005
Defining Ocular Surface Disease Activity and Damage Indices by an International Delphi Consultation.
Priscilla A Mathewson (2017)
10.1093/rheumatology/keh140
Patient-reported outcomes better discriminate active treatment from placebo in randomized controlled trials in rheumatoid arthritis.
V. Strand (2004)
10.1093/rheumatology/35.2.184
An overview of disability.
F T Fitzpatrick (1996)
10.1007/s11136-013-0415-8
A comparison of directly elicited and pre-scored preference-based measures of quality of life: the case of adhesive capsulitis
Anthony Harris (2013)
10.1016/J.INJR.2013.05.002
Comparative validation of clinical disease activity index (CDAI) and simplified disease activity index (SDAI) in rheumatoid arthritis in India
Siddhanagouda Malibiradar (2013)
A multidimensional health assessment questionnaire (MDHAQ) for all patients with rheumatic diseases to complete at all visits in standard clinical care.
Theodore Pincus (2007)
The Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI): a review of their usefulness and validity in rheumatoid arthritis.
D. Aletaha (2005)
10.2217/17460816.2.5.439
Fatigue in rheumatoid arthritis: from apathy to action
Sarah E Hewlett (2007)
10.1016/s0254-6272(15)30097-2
Effect of sanhuangwuji powder, anti-rheumatic drugs, and ginger-partitioned acupoint stimulation on the treatment of rheumatoid arthritis with peptic ulcer: a randomized controlled study.
Defang Liu (2015)
10.7326/0003-4819-122-2-199501150-00001
Minocycline in Rheumatoid Arthritis: A 48-Week, Double-Blind, Placebo-Controlled Trial
B. Tilley (1995)
10.1056/NEJMoa1615977
Tofacitinib for Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors
Dafna Gladman (2017)
10.4172/1758-4272.1000170
Methotrexate and leflunomide survival in patients with psoriatic arthritis
Zaffarana Ca (2018)
IL1β+3953 exon 5 and IL-2 -330 promoter polymorphisms in patients with rheumatoid arthritis
Andrzej Pawlik (2005)
The consequences of rheumatoid arthritis: quality of life measures in the individual patient.
L. Pollard (2005)
10.1111/1756-185X.12789
Patient‐reported outcomes as assessment tools and predictors of long‐term prognosis: a 7‐year follow‐up study of patients with rheumatoid arthritis
Masayo Kojima (2017)
10.1097/MD.0000000000014424
The efficacy of the traditional Chinese medicine Jia Wei Niu Bang Zi granule combined with methotrexate in treating active rheumatoid arthritis
Yi-ru Wang (2019)
10.1136/rmdopen-2016-000416
Sarilumab improves patient-reported outcomes in rheumatoid arthritis patients with inadequate response/intolerance to tumour necrosis factor inhibitors
Vibeke Strand (2017)
10.3109/14397595.2014.948587
Validation of RAPID3 using a Japanese version of Multidimensional Health Assessment Questionnaire with Japanese rheumatoid arthritis patients: Characteristics of RAPID3 compared to DAS28 and CDAI
Naoto Yokogawa (2015)
EXPLORING A NATIONAL PRACTICE- BASED REGISTER FOR THE MANAGEMENT OF RHEUMATOID ARTHRITIS
Cheryl Carli (2008)
10.1002/j.2048-7940.2010.tb00035.x
Rheumatoid Arthritis: Coping with Disability
Tara L. Barker (2010)
10.1136/ard.2009.123919
Treating rheumatoid arthritis to target: recommendations of an international task force
Josef S Smolen (2010)
10.1016/j.rdc.2010.02.007
How should rheumatoid arthritis disease activity be measured today and in the future in clinical care?
Tuulikki Sokka (2010)
10.3109/03009742.2011.566433
Morning symptoms in rheumatoid arthritis: a defining characteristic and marker of active disease
Stanisław Sierakowski (2011)
10.1136/ard.2011.151522
Ofatumumab, a fully human anti-CD20 monoclonal antibody, in biological-naive, rheumatoid arthritis patients with an inadequate response to methotrexate: a randomised, double-blind, placebo-controlled clinical trial
Peter C. Taylor (2011)
See more
Semantic Scholar Logo Some data provided by SemanticScholar