Rheumatoid Arthritis: Tugwell PS

Maxwell L, Santesso N, Tugwell PS, Wells GA, Judd M, Buchbinder R. · Cochrane Musculoskeletal Group, Institute of Population Health, University of Ottawa, 1 Stewart Street, Ottawa, Ontario, Canada. · J Rheumatol. · Pubmed #17086611 No free full text.

Abstract: The Cochrane Musculoskeletal Group (CMSG), one of 50 groups of the not-for-profit international Cochrane Collaboration, prepares, maintains, and disseminates systematic reviews of treatments for musculoskeletal diseases. To enhance the quality and usability of systematic reviews, the CMSG has developed tailored methodological guidelines for authors of CMSG systematic reviews. Recommendations specific to musculoskeletal disorders are provided for various aspects of undertaking a systematic review, including literature searching, inclusion criteria, quality assessment, grading of evidence, data collection, and data analysis. These guidelines will help researchers design, conduct, and report results of systematic reviews of trials in the following fields of musculoskeletal health: gout, osteoarthritis, osteoporosis, pediatric rheumatology, rheumatoid arthritis, soft tissue rheumatism, spondyloarthropathy, systemic lupus erythematosus, systemic sclerosis, and vasculitis. Systematic reviews need to be conducted according to high methodological standards. These recommendations on developing and performing a systematic review will help improve consistency among CMSG reviews.

Wells GA, Boers M, Li T, Tugwell PS. · Department of Epidemiology and Community Medicine, University of Ottawa, 451 Smyth Road, Ottawa, Ontario KIH 8M5, Canada. · J Rheumatol. · Pubmed #19208559 No free full text.

Abstract: OBJECTIVE: To validate the definitions of minimal disease activity (MDA) in patients with rheumatoid arthritis (RA) and to compare abatacept to control with respect to patients attaining a state of MDA. METHODS: Two randomized controlled trials comparing abatacept to control in patients with RA were considered: ATTAIN and AIM. Core set measures, Disease Activity Score 28-joint count (DAS28), and, for AIM, radiographic scores were available. The core set and DAS-based definitions for MDA were calculated and the number of patients in the treatment groups meeting the definitions was compared to determine sensitivity of the criteria to treatment differences and patient severity. The number of times achieving MDA was compared to the change in Health Assessment Questionnaire (HAQ), and for the AIM study compared to change in radiographic scores. RESULTS: For both definitions of MDA, the change in radiographic scores showed a continual decrease in progression the more often a patient was in MDA. The change in HAQ, for both studies, showed a similar consistent improvement - the longer a patient was in MDA, then the better the HAQ score. Significantly more patients in the abatacept group met the core set and DAS-based definition of MDA than in the control group. CONCLUSION: The presence and persistence of MDA was associated with slowing of radiographic progression and improvement in the HAQ, providing support for discriminative and predictive validity of the measure. The MDA results were consistent with other efficacy analyses indicating a treatment advantage for abatacept.

Tugwell PS, Wilson AJ, Brooks PM, Driedger SM, Gallois C, O'Connor AM, Qualman A, Santesso N, Wale J, Wells GA. · University of Ottawa, Ottawa, Canada. · J Rheumatol. · Pubmed #16265713 No free full text.

Abstract: The OMERACT 7 Effective Musculoskeletal Consumer Workshop brought together people with rheumatoid arthritis, healthcare professionals, and researchers to discuss what they thought made a musculoskeletal consumer effective at managing their disease. Preliminary work before OMERACT provided a draft list of potential characteristics of an effective consumer. Participants at the workshop provided feedback about the list including relevance, missing items, format, and language. The feedback provided was useful and will be incorporated into a revised list to aid in the development of an instrument to measure health consumer effectiveness.

Lassere MN, Johnson KR, Boers M, Carlton K, Day RO, de Wit M, Edwards IR, Fries JF, Furst DE, Kirwan JR, Tugwell PS, Woodworth TG, Brooks PM. · Department of Rheumatology, University of New South Wales, St. George Hospital, Belgrave Street, Kogarah, Sydney, 2127 NSW, Australia. · J Rheumatol. · Pubmed #16206366 No free full text.

Abstract: A presentation, demonstration, and discussion of recently developed adverse event instruments were the topics for the OMERACT 7 Drug Safety Module. The module began with a plenary introducing the needs and challenges of adverse event ascertainment. It was followed by a review of module work from previous OMERACT meetings on a prototype coding instrument (Rheumatology Common Toxicity Criteria), then a brief description of the process behind the recently developed patient self-report and investigator report adverse event instruments. These current instruments are designed for use in controlled trials although they could be used in other settings. The instruments rely primarily on patient self-reporting using a checklist, which the investigator then folds into a parallel structured but more medically sophisticated instrument. In pilot testing, this innovative dual-use system has shown reliability and acceptability, while preserving validity. A "stakeholder panel" of representatives from 8 sectors followed--patient, nurse investigator, regulator, clinician scientist, industry, OMERACT, global public health/WHO, and Cochrane Collaboration--for their perspectives on the needs, challenges, and potential ways forward for adverse event ascertainment and reporting in clinical trials. At the breakout session small focus groups participated in hands-on interactive testing of one of 3 versions of the instruments, which differ in degree of comprehensiveness. Each focus group had a participatory patient with rheumatoid arthritis. At a second plenary there was group feedback by rapporteurs and presentation of results from pilot studies of iterative testing of validity, reliability, and feasibility of the instruments. During plenary discussion a frequent suggestion for improvement was to refine the process so that event ascertainment could be done entirely using the patient instrument with minimal input from the investigator at the visit, if patient-investigator agreement was high. Most found the patient checklist attractive, particularly if the patient instrument was shown to be reliable and valid. Finally, a future research agenda was discussed.

Wells GA, Boers M, Shea B, Brooks PM, Simon LS, Strand CV, Aletaha D, Anderson JJ, Bombardier C, Dougados M, Emery P, Felson DT, Fransen J, Furst DE, Hazes JM, Johnson KR, Kirwan JR, Landewé RB, Lassere MN, Michaud K, Suarez-Almazor M, Silman AJ, Smolen JS, Van der Heijde DM, van Riel PL, Wolfe F, Tugwell PS. · Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada. · J Rheumatol. · Pubmed #16206362 No free full text.

Abstract: Agreement on response criteria in rheumatoid arthritis (RA) has allowed better standardization and interpretation of clinical trial reports. With recent advances in therapy, the proportion of patients achieving a satisfactory state of minimal disease activity (MDA) is becoming a more important measure with which to compare different treatment strategies. The threshold for MDA is between high disease activity and remission and, by definition, anyone in remission will also be in MDA. True remission is still rare in RA; in addition, the American College of Rheumatology definition is difficult to apply in the context of trials. Participants at OMERACT 6 in 2002 agreed on a conceptual definition of minimal disease activity (MDA): "that state of disease activity deemed a useful target of treatment by both the patient and the physician, given current treatment possibilities and limitations." To prepare for a preliminary operational definition of MDA for use in clinical trials, we asked rheumatologists to assess 60 patient profiles describing real RA patients seen in routine clinical practice. Based on their responses, several candidate definitions for MDA were designed and discussed at the OMERACT 7 in 2004. Feedback from participants and additional on-site analyses in a cross-sectional database allowed the formulation of 2 preliminary, equivalent definitions of MDA: one based on the Disease Activity Score 28 (DAS28) index, and one based on meeting cutpoints in 5 out the 7 WHO/ILAR core set measures. Researchers applying these definitions first need to choose whether to use the DAS28 or the core set definition, because although each selects a similar proportion in a population, these are not always the same patients. In both MDA definitions, an initial decision node places all patients in MDA who have a tender joint count of 0 and a swollen joint count of 0, and an erythrocyte sedimentation rate (ESR) no greater than 10 mm. If this condition is not met: * The DAS28 definition places patients in MDA when DAS28 < or = 2.85; * The core set definition places patients in MDA when they meet 5 of 7 criteria: (1) Pain (0-10) < or = 2; (2) Swollen joint count (0-28) < or = 1; (3) Tender joint count (0-28) < or = 1; (4) Health Assessment Questionnaire (HAQ, 0-3) < or = 0.5; (5) Physician global assessment of disease activity (0-10) < or = 1.5; (6) Patient global assessment of disease activity (0-10) < or = 2; (7) ESR < or = 20. This set of 2 definitions gained approval of 73% of the attendees. These (and other) definitions will now be subject to further validation in other databases.