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OMERACT 7 Special Interest Group

Publications and source records attributed to OMERACT 7 Special Interest Group.

12 recordsLinked to original sources
PubMed2005

Concomitant therapies as an outcome measure. Part 1: Drugs.

Concomitant therapy intake (i.e., drugs other than the study drug) could potentially be used as an outcome measure in therapeutic trials in musculoskeletal disorders. The objective of this Special Interest Group (Part 1) was to investigate this possibility. Concomitant therapy intake could be used as an outcome measure in 2 ways: either as an associated outcome measure if it was determined there was interaction between the study drug and the concomitant drug, or as an outcome measure in itself if concomitant drug intake was deemed important in its own right and fulfilled the OMERACT filter requirement. These 2 aspects were discussed in the session and then put to a vote.

Endpoint Determination↗
PubMed2005

Concomitant therapy: an outcome variable for musculoskeletal disorders? Part 2: total joint replacement in osteoarthritis trials.

Interest has grown in using the requirement of total joint replacement (TJR) as a "hard" outcome measure. Limitations exist, however, in the use of such an outcome, in particular the variability in the decision to perform surgery, length of surgical waiting lists, and sensitivity to change. This special interest group is exploring ways of retaining the clinical relevance of TJR but overcoming the problems--2 alternative outcomes are being considered: "time to physician's decision to recommend surgery" and "time to fulfilling criteria for total joint replacement."

Arthroplasty, Replacement↗
PubMed2005

Outcome measures for acute and chronic gout.

Gout provides some unique challenges in classification and measurement of outcomes. Our aim was to evaluate criteria for classification and to develop and validate optimal instruments to measure outcomes for acute and chronic gout. A planning committee and interested attendees met to propose classification criteria and domains for outcomes. Seven of the current American Rheumatism Association preliminary criteria for classification were proposed as the best current criteria for acute gouty arthritis, pending further studies. The presence of gout is best established by crystal identification, although this technique has limitations. Five domains for acute gout outcomes and 9 for chronic gout were identified along with proposed instruments for testing and validation. The unique problems of gout evaluation can and will be addressed.

Acute Disease↗
PubMed2005

Measurement of joint space width and erosion size.

Measurement of radiographic abnormalities in metric units has been reported by several investigators during the last 15 years. Measurement of joint space in large joints has been employed in a few trials to evaluate therapy in osteoarthritis. Measurement of joint space width in small joints has been reported by several investigators but has not yet found a place in clinical trials in rheumatoid arthritis or osteoarthritis. We review methods for measuring joint space width in finger, toe, and wrist joints; special attention is given to how the joint edges are found, the method used to measure distance between joint margins, size of an area of the sampled joint, and reproducibility of measurements. Methods for measurement of erosion size, which have had less attention, are briefly discussed.

Arthrography↗
PubMed2005

The evidence for magnetic resonance imaging as an outcome measure in proof-of-concept rheumatoid arthritis studies.

Magnetic resonance imaging (MRI) has now been used extensively in cross-sectional and observational studies as well as in controlled clinical trials to assess disease activity and joint damage in rheumatoid arthritis (RA). MRI measurements or scores for erosions, bone edema, and synovitis have been developed and validated by several groups. The OMERACT criteria require that outcome measures demonstrate adequate validity, discriminative power, and feasibility if they are to be useful in clinical trials. Specific performance targets for these criteria depend on the scientific, regulatory, logistical, and financial context of the study in question. We review the extent to which MRI assessments of joint erosion, bone edema, and synovitis fulfil these criteria, particularly as they relate to proof-of-concept RA clinical trials.

Arthritis, Rheumatoid↗
PubMed2005

The design and evaluation of psychoeducational/self-management interventions.

A large number of interventions have been developed with the aim of improving patient self-management of arthritis. These interventions are complex, usually including multiple components, and have certain key features including participants' awareness of the arms of the study and their often having clear preferences for one or other arm. Because of these and other differences the randomized controlled trial is not necessarily ideal for studies of self-management interventions. This special interest group (SIG) considered designs that may be more appropriate. Self-management interventions use a wide range of outcome measures, which are often assessed at a range of time periods after the intervention. Evaluation of the efficacy of self-management interventions was discussed. One important issue is to link the expected influence of the intervention to the key assessment of outcome. The SIG also examined the factors that may influence the effectiveness of self-management interventions.

Arthritis↗
PubMed2005

Reconciling subject differences in recruitment to clinical trials and clinical practice.

The special interest group on Reconciling Subject Differences was centered around the issue that the results from randomized clinical trials do not predict response to therapies in clinical practice, and around the hypothesis that this might be explained by differences in subjects selected for clinical trials compared to those treated in routine practice.

Arthritis, Rheumatoid↗
PubMed2005

Scleroderma--developing measures of response.

The scleroderma research community continued its focus on the development and proper validation of the outcome measures for clinical trials in scleroderma during the special interest group meeting at OMERACT 7. Deliberations focused on progress in the assessment of gastrointestinal disease, renal physiology, vascular damage, and the unique challenges inherent in studying pediatric patients with scleroderma.

Adolescent↗
PubMed2005

Synovial tissue analysis in clinical trials.

Synovial tissue analysis has considerable potential for future randomized controlled trials (RCT). The synovial membrane is the target tissue in treatment strategies of rheumatoid arthritis and other arthropathies. Effective modulation of synovitis is critical when attempting to control symptoms and signs, to prevent joint damage, and to maintain function. In RCT, the systematic evaluation of changes in synovial tissue after commencing treatment enables identification of an early therapeutic effect, using relatively small numbers of patients. This special interest group is working on establishing the evidence to have this endpoint meet the OMERACT filter criteria.

Antirheumatic Agents↗
PubMed2005

Musculoskeletal ultrasound including definitions for ultrasonographic pathology.

Ultrasound (US) has great potential as an outcome in rheumatoid arthritis trials for detecting bone erosions, synovitis, tendon disease, and enthesopathy. It has a number of distinct advantages over magnetic resonance imaging, including good patient tolerability and ability to scan multiple joints in a short period of time. However, there are scarce data regarding its validity, reproducibility, and responsiveness to change, making interpretation and comparison of studies difficult. In particular, there are limited data describing standardized scanning methodology and standardized definitions of US pathologies. This article presents the first report from the OMERACT ultrasound special interest group, which has compared US against the criteria of the OMERACT filter. Also proposed for the first time are consensus US definitions for common pathological lesions seen in patients with inflammatory arthritis.

Arthritis, Rheumatoid↗
PubMed2005

Current status of outcome measures in vasculitis: focus on Wegener's granulomatosis and microscopic polyangiitis. Report from OMERACT 7.

The complexity of assessing disease activity, disease status, and damage in the vasculitides reflects the multisystemic pathologic manifestations of these often chronic illnesses. Major progress has been made in the past decade in the development of validated and widely accepted outcome measures for use in clinical trials. Over time, these tools have been regularly revised, expanded, and supplemented with new measures of disease prognosis and damage. As a result clinical research in this area has become increasingly complex. This article critically reviews the current status of tools for assessing disease activity and damage in "ANCA-associated" vasculitides (Wegener's granulomatosis and microscopic polyangiitis), summarizes the current level of validation of each measure, addresses central problems and controversies to be considered during development of new vasculitis assessment tools, and proposes a series of research agendas for consideration by the vasculitis research community.

Clinical Trials as Topic↗