Outcome Measures In Rheumatology Clinical Trials Research Articles

Developing a Construct to Evaluate Flares in Rheumatoid Arthritis: A Conceptual Report of the OMERACT RA Flare Definition Working Group: Table 1.

Rheumatoid arthritis (RA) patients and healthcare professionals (HCP) recognize that episodic worsening disease activity, often described as a "flare," is a common feature of RA that can contribute to impaired function and disability. However, there is no standard definition to enable measurement of its intensity and impact. The conceptual framework of the Outcome Measures in Rheumatology Clinical Trials (OMERACT) RA Flare Definition Working Group includes an anchoring statement, developed at OMERACT 9 in 2008: "flare in RA" is defined as worsening of signs and symptoms of sufficient intensity and duration to lead to change in therapy. Subsequently, domains characterizing flare have been identified by comprehensive literature review, patient focus groups, and patient/HCP Delphi exercises. This led to a consensus regarding preliminary domains and a research agenda at OMERACT 10 in May 2010. The conceptual framework of flare takes into account validated approaches to measurement in RA: (1) various disease activity indices (e.g., Disease Activity Score, Clinical Disease Activity Index, Simplified Disease Activity Index); (2) use of patient-reported outcomes (PRO); and (3) characterization of minimally clinically detectable and important differences (MCDD, MCID). The measurement of RA flare is composed of data collection assessing a range of unique domains describing key features of RA worsening at the time of patient self-report of flare, and then periodically for the duration of the flare. The components envisioned are: (1) Patient self-report using a "patient global question" with well characterized and validated anchors; (2) Patient assessment using a flare questionnaire and PRO available at the time of each self-report; (3) Physician/HCP assessment of disease activity status; and (4) Physician's determination whether to change treatment. In randomized controlled trials and observational studies, such a conceptual approach is intended to lead to a valid measure of this outcome/response, thus expanding an understanding of the true impact of a therapy to limit disease activity. Clinically, this approach is intended to enhance patient-HCP communication. This article describes the conceptual framework being used by the OMERACT RA Flare Definition Working Group in developing a standardized method for description and measurement of "flare in RA" to guide individual patient treatment.

Identifying Preliminary Domains to Detect and Measure Rheumatoid Arthritis Flares: Report of the OMERACT 10 RA Flare Workshop

While disease flares in rheumatoid arthritis (RA) are a recognized aspect of the disease process, there is limited formative research to describe them. The Outcome Measures in Rheumatology Clinical Trials (OMERACT) RA Flare Definition Working Group is conducting an international research project to understand the specific characteristics and impact of episodic disease worsening, or "flare," so that outcome measures can be developed or modified to reflect this uncommonly measured, but very real and sometimes disabling RA disease feature. Patient research partners provided critical insights into the multidimensional nature of flare. The perspectives of patients and healthcare and research professionals are being integrated to ensure that any outcome measurement to detect flares fulfills the first OMERACT criteria of Truth. Through an iterative data-driven Delphi process, a preliminary list of key domains has been identified to evaluate flare. At OMERACT 10, consensus was achieved identifying features of flare in addition to the existing core set for RA, including fatigue, stiffness, symptom persistence, systemic features, and participation. Patient self-report of flare was identified as a component of the research agenda needed to establish criterion validity for a flare definition; this can be used in prospective studies to further evaluate the Discrimination and Feasibility components of the OMERACT filter for a flare outcome measure. Our work to date has provided better understanding of key aspects of the RA disease process as episodic, potentially disabling disease worsening even when a patient is in low disease activity. It also highlights the importance of developing ways to enhance communication between patients and clinicians and improve the ability to achieve "tight control" of disease.

Influencing Health Equity: Role of the Effective Consumer Scale in Measuring Skills and Abilities in a Middle Income Country

The 2008 World Health Report emphasizes the need for patient-centered primary care service delivery models in which patients are equal partners in the planning and management of their health. It is argued that this involvement will lead to improved management of disease, improved health outcomes and patient satisfaction, better informed decision-making, increased compliance with healthcare decisions, and better resource utilization. This article investigates the domains captured by the Effective Consumer Scale (EC-17) in relation to vulnerable population groups that experience health inequity. Particular focus is paid to the domain of health literacy as an area fundamental to patients' involvement in managing their condition and negotiating the healthcare system. In examining the possible influence of Outcome Measures in Rheumatology Clinical Trials (OMERACT) on health equity, we used the recent translation and validation of the EC-17 scale into Spanish and tested Argentina as an example. Future plans to use the EC-17 with vulnerable groups include formal collaboration and needs assessment with the community to tailor an intervention to meet its needs in a culturally relevant manner. Some systematic reviews have questioned whether interventions to improve effective consumer skills are appropriate in vulnerable populations. We propose that these populations may have the most to gain from such interventions since they might be expected to have relatively lower skills and health literacy than other groups.

Health Literacy: What Is It and Why Is It Important to Measure?

This report summarizes the proceedings of the first Outcome Measures in Rheumatology Clinical Trials (OMERACT) Health Literacy Special Interest Group workshop at the OMERACT 10 conference. Health literacy refers to an individual's capacity to seek, understand, and use health information. Discussion centered on the relevance of health literacy to the rheumatology field; whether measures of health literacy were important in the context of clinical trials and routine care; and, if so, whether disease-specific measures were required. A nominal group process involving 27 workshop participants, comprising a patient group (n = 12) and a healthcare professional and researcher group (n = 15), confirmed that health literacy encompasses a broad range of concepts and skills that existing scales do not measure. It identified the importance and relevance of patient abilities and characteristics, but also health professional factors and broader contextual factors. Sixteen themes were identified: access to information; cognitive capacity; disease; expression/communication; finances; health professionals; health system; information; literacy/numeracy; management skills; medication; patient approach; dealing with problems; psychological characteristics; social supports; and time. Each of these was divided further into subthemes of one or more of the following: knowledge, attitude, attribute, relationship, skill, action, or context. There were virtually no musculoskeletal-specific statements, suggesting that a generic health literacy tool in rheumatology is justified. The detailed concepts across themes provided new and systematic insight into what needs to be done to improve health literacy and consequently reduce health inequalities. These data will be used to derive a more comprehensive measure of health literacy.

Nonpharmacologic Interventions Need Outcomes for Evaluating Complex Interventions in Rheumatic Diseases

Nonpharmacologic interventions are themselves complex and are often combined with drugs and other interventions in the treatment of rheumatic diseases. Therefore, overall strategies for treatment are complex interventions. These should be evaluated regarding their processes and outcomes. The CARE network, an international organization of health professionals (physicians and nonphysicians) and patients conducted a survey in 2008 to identify core outcomes in the ICF perspective, completed with a second survey (2009-2010) with patients in routine practice. These surveys have provided new information about domains to investigate as a basis for evaluating complex interventions. Outcome Measures in Rheumatology Clinical Trials (OMERACT) participants in this Special Interest Group agreed that current outcomes used in pharmacological research are not sufficient if the nonpharmacologic independent or combined contributions are to be assessed; other domains need to be addressed. This is an area of interest for further development. Recommendations are proposed to develop research in the area of outcome for evaluation of complex interventions in rheumatic diseases.

Development of a Disease Severity and Responder Index for Psoriatic Arthritis (PsA) — Report of the OMERACT 10 PsA Special Interest Group

Work within the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) to develop and validate composite disease activity measures in PsA has progressed. At the Outcome Measures in Rheumatology Clinical Trials (OMERACT) 8 meeting, a core set of domains to be assessed in randomized controlled trials (RCT) and longitudinal observational studies (LOS) of PsA was agreed upon. At OMERACT 10, work to date regarding proposed composite responder indices was presented. Five proposed composite responder definitions for PsA were reviewed and discussed including new data from the GRACE (GRAppa Composite Exercise) study. There was agreement that the work to date was promising, and that developing composite outcome measures for use in RCT and LOS was important. Further work was required, including data on followup timepoints and less common phenotypes of PsA, to ensure that all subgroups were represented within GRACE. During discussion on the concept of composite measures for PsA, based on predominant/little/no involvement in several domains (such as skin versus joints, enthesitis, dactylitis, spondyloarthritis) it was acknowledged that a simple summative score encompassing all domains of PsA would be difficult to construct psychometrically and may not be appropriate. Ideally, any composite measure should retain the ability to differentiate between activity in individual domains, such as enthesitis or skin psoriasis, so that the influence of each can be assessed independently. Further work is required within the GRACE dataset to develop an optimal composite measure for PsA. Several proposals to date have shown preliminary validity according to the OMERACT filter.

Toward Development of a Fibromyalgia Responder Index and Disease Activity Score: OMERACT Module Update

Following development of the core domain set for fibromyalgia (FM) in Outcome Measures in Rheumatology Clinical Trials (OMERACT) meetings 7 to 9, the FM working group has progressed toward the development of an FM responder index and a disease activity score based on these domains, utilizing outcome indices of these domains from archived randomized clinical trials in FM. Possible clinical domains that could be included in a responder index and disease activity score include pain, fatigue, sleep disturbance, cognitive dysfunction, mood disturbance, tenderness, stiffness, and functional impairment. Outcome measures for these domains demonstrate good to adequate psychometric properties, although measures of cognitive dysfunction need to be further developed. The approach used in the development of responder indices and disease activity scores for rheumatoid arthritis and ankylosing spondylitis represents heuristic models for our work, but FM is challenging in that there is no clear algorithm of treatment that defines disease activity based on treatment decisions, nor are there objective markers that define thresholds of severity or response to treatment. The process of developing candidate dichotomous responder definitions and continuous quantitative disease activity measures is described, along with participant discussions from OMERACT 10. Final results of this work will be published in a separate report pending completion of analyses.

Extremity magnetic resonance imaging in rheumatoid arthritis: Updated literature review.

Introduction In April 2006, a white paper on extremity magnetic resonance imaging (MRI) in rheumatoid arthritis (RA) was published, based on a review of the literature by a task force commissioned by the American College of Rheumatology (ACR) (1). The document was well received for its scientific rigor and overview of the literature at that time. However, the report had unexpected consequences as certain insurers began to restrict coverage for extremity MRI, which was not the intent of the original scientific review. Over the last 4 years, research into the value of extremity MRI and its role compared with conventional radiography and high-field MRI has been ongoing. In May 2009, the International Society of Extremity MRI in Rheumatology (ISEMIR) forwarded to the ACR publications they believed to be important in the field, requesting that the ACR review these new data and update the white paper with inclusion of the new information. The ACR Executive Committee and ACR Board of Directors thought that it was important to respond to this group, but due to the many efforts the ACR had ongoing, it was decided not to reconvene the original formal task force. Three members of the initial task force were asked to participate in this literature review: Atul Deodhar (an academic clinical rheumatologist with research interest in imaging modalities), to provide clinical perspective; Hollis Potter (a musculoskeletal radiologist with extensive experience in MRI), to provide technical expertise; and Stanley Cohen (a clinical rheumatologist in private practice with research interests in RA treatment). Paul Emery, who was not a member of the original task force, was asked to participate due to his expertise in MRI in RA as well as his involvement in the ISEMIR. Subsequent to the initial development of the manuscript, Philip Conaghan and Mikkel Ostergaard were invited to contribute to the review based on their expertise in the field and the desire of the working group as well as the ACR Board of Directors to broaden the perspective on this subject. This group reviewed the publications forwarded, as well as conducted a literature review of additional articles in Medline and PubMed involving MRI in RA published since 2006. This was not a formal evidence-based review such as the nowpopular RAND-based methodology, but simply a literature review addressing the same questions raised in 2006 to determine if the conclusions reached at that time should be modified. These publications can be broadly divided into 3 groups. The first group of publications deals with technical aspects, such as comparing low-field extremity units to high-field units, comparing the reproducibility of results obtained with low-field units in different centers, or addressing the Outcome Measures in Rheumatology Clinical Trials (OMERACT) MRI scoring systems. The second group consists of publications that confirm previously recorded observations, e.g., MRI scanning is more sensitive in detecting erosions compared with conventional radiography and predicts future radiographic erosions. The third group consists of publications that advance our knowledge of peripheral MRI further by breaking new ground. Although there are now extremity MRI units that are higher field at 1.0–1.5T, there was no available literature to determine the role of high-field extremity MRI in the diagnosis and management of RA. Stanley B. Cohen, MD: Presbyterian Hospital and University of Texas Southwestern Medical School, Dallas; Hollis Potter, MD: Hospital for Special Surgery and Weill Medical College of Cornell University, New York, New York; Atul Deodhar, MD: Rheumatology Clinics, Oregon Health and Science University, Portland; Paul Emery, MA, MD, FRCP, Philip Conaghan, MBBS, PhD, FRACP, FRCP: University of Leeds and National Institute of Health Research Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK; Mikkel Ostergaard, MD: Copenhagen University Hospital at Glostrup and Hvidovre, Copenhagen, Denmark. Dr. Potter has received institutional research support from General Electric Healthcare. Dr. Deodhar has received consultant fees, speaking fees, and/or honoraria (less than $10,000) from Centocor. Dr. Emery has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from MSD, Pfizer, Roche, BMS, and Abbott. Dr. Conaghan has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from BMS, Centocor, MSD, Novartis, Roche, and Pfizer. Address correspondence to Stanley B. Cohen, MD, 8144 Walnut Hill, Suite 800, Dallas, TX 75231. E-mail: Arthdoc@aol.com. Submitted for publication August 25, 2010; accepted November 22, 2010. Arthritis Care & Research Vol. 63, No. 5, May 2011, pp 660–665 DOI 10.1002/acr.20413 © 2011, American College of Rheumatology

Juvenile idiopathic arthritis—recent advances

Juvenile idiopathic arthritis—recent advances

Standardizing the monitoring of outcome measures: imaging in psoriatic arthritis

The wide spectrum of manifestations of musculoskeletal inflammation in psoriatic arthritis makes standardized assessment of joint damage in psoriatic arthritis a challenge. Assessment of erosions and joint space narrowing on plain radiographs of the hands and feet has remained the benchmark for assessing damage in psoriatic arthritis. The methods used to assess damage have been mostly borrowed from those used in rheumatoid arthritis. Axial joint involvement has not been systematically addressed. Methods to assess spinal disease have been borrowed from those used in ankylosing spondylitis. Both ultrasound and MRI have demonstrated promise in the assessment of psoriatic arthritis. The Outcome Measures in Rheumatology Clinical Trials (OMERACT) group is involved in the development of valid, reliable and feasible methods for assessment of joint involvement in psoriatic arthritis.

Change in CD3 positive T-cell expression in psoriatic arthritis synovium correlates with change in DAS28 and magnetic resonance imaging synovitis scores following initiation of biologic therapy - a single centre, open-label study

IntroductionWith the development of increasing numbers of potential therapeutic agents in inflammatory disease comes the need for effective biomarkers to help screen for drug efficacy and optimal dosing regimens early in the clinical trial process. This need has been recognized by the Outcome Measures in Rheumatology Clinical Trials (OMERACT) group, which has established guidelines for biomarker validation. To seek a candidate synovial biomarker of treatment response in psoriatic arthritis (PsA), we determined whether changes in immunohistochemical markers of synovial inflammation correlate with changes in disease activity scores assessing 28 joints (ΔDAS28) or magnetic resonance imaging synovitis scores (ΔMRI) in patients with PsA treated with a biologic agent.MethodsTwenty-five consecutive patients with PsA underwent arthroscopic synovial biopsies and MRI scans of an inflamed knee joint at baseline and 12 weeks after starting treatment with either anakinra (first 10 patients) or etanercept (subsequent 15 patients) in two sequential studies of identical design. DAS28 scores were measured at both time points. Immunohistochemical staining for CD3, CD68 and Factor VIII (FVIII) was performed on synovial samples and scored by digital image analysis (DIA). MRI scans performed at baseline and at 12 weeks were scored for synovitis semi-quantitatively. The ΔDAS28 of the European League Against Rheumatism good response definition (>1.2) was chosen to divide patients into responder and non-responder groups. Differences between groups (Mann Whitney U test) and correlations between ΔDAS28 with change in immunohistochemical and MRI synovitis scores (Spearman's rho test) were calculated.ResultsPaired synovial samples and MRI scans were available for 21 patients (8 anakinra, 13 etanercept) and 23 patients (8 anakinra, 15 etanercept) respectively. Change in CD3 (ΔCD3) and CD68 expression in the synovial sublining layer (ΔCD68sl) was significantly greater in the disease responders compared to non-responders following treatment (P = 0.005 and 0.013 respectively). ΔCD3, but not ΔCD68 or ΔFVIII, correlated with both ΔDAS28 (r = 0.49, P = 0.025) and ΔMRI (r = 0.58, P = 0.009).ConclusionsThe correlation of ΔCD3 with ΔDAS28 and ΔMRI following biologic treatment in this cohort contributes to the validation of ΔCD3 as a synovial biomarker of disease response in PsA, and supports the further evaluation of ΔCD3 for predictive properties of future clinical outcomes.

Biomarkers in the Management of Scleroderma: An Update

Scleroderma, or systemic sclerosis, is a clinically heterogeneous disease characterized by fibroproliferative vasculopathy, tissue fibrosis affecting the skin and internal organs, and autoimmune activation. Many biomarker candidates have been identified in the past two decades; however, fully validated measures are still lacking with regard to aiding in the early diagnosis and reflecting the disease activity, severity, prognosis, and response to therapy. An ideal biomarker should be highly sensitive and specific, reflecting the current status of disease; should be related to the disease activity and/or severity in accordance with the clinical evolution; should anticipate clinical changes before they occur; and should add independent information about the risk or prognosis that is reproducible and feasible. This review focuses on the most recent and innovative approaches to identify biomarkers, such as extensive gene expression analysis and proteomics, and on markers and surrogate outcome measures closer to clinical practice, and attempts to evaluate them through the OMERACT (Outcome Measures in Rheumatology Clinical Trials) filter.

Patient‐reported outcomes one year after primary hip replacement in a European Collaborative Cohort

To identify whether patients have symptomatic improvement 12 months following total hip replacement (THR) surgery. The European Collaborative Database of Cost and Practice Patterns of Total Hip Replacement study consists of 1,327 patients receiving primary THR for osteoarthritis (OA) across 20 European orthopedic centers. The primary outcome was the difference in Western Ontario and McMaster Universities OA Index (WOMAC) score between preoperative and 12-month postoperative measurements. To classify whether patients responded to THR at 12 months, we used return to normal, Outcome Measures in Rheumatology Clinical Trials (OMERACT)-OA Research Society International (OARSI) criteria, minimum important difference (MID), and minimum clinically important difference. Exposures were age, sex, obesity, employment, educational attainment, American Society of Anesthesiologists status, and radiographs. On average, there was a large improvement in WOMAC scores 12 months after surgery, but whereas some patients improved, others got worse. The OMERACT-OARSI method classified 85.7% of patients as responders, MID 70.1%, and return to normal 64.1%. In general, each approach classified the same groups of patients as responding to THR. Based on total WOMAC score, patients who were younger, morbidly obese, employed, and better educated were more likely to respond to THR, but the effects were attenuated after adjustment for confounding, with only the effect of education remaining important. The overall average response to THR was good, but approximately 14-36% of patients did not improve, or were worse, 12 months postsurgery. Although the OMERACT-OARSI criteria were originally designed for use in clinical drug trials, they performed well in classifying patient response 12 months post-THR. Further research is required to understand the determinants of patient outcomes following THR.

Magnetic resonance imaging in the assessment of metacarpophalangeal joint disease in early psoriatic and rheumatoid arthritis

Objectives: The aim of this study was to determine whether magnetic resonance imaging (MRI)‐related entheseal changes including osteitis and extracapsular oedema could be used to differentiate between metacarpophalangeal (MCP) joint involvement in rheumatoid arthritis (RA) and psoriatic arthritis (PsA).Methods: Twenty patients (10 each with early RA and PsA) had dynamic contrast‐enhanced MRI (DCE‐MRI) of swollen MCP joints. Synovitis and tenosynovitis was calculated using quantitative analysis including the degree and kinetics of enhancement of gadolinium diethylenetriaminepentaacetic acid (Gd‐DTPA). Periarticular bone erosion and bone oedema were scored using the Outcome Measures in Rheumatology Clinical Trials (OMERACT) proposals. Entheseal‐related features including extracapsular soft tissue enhancement or regions of diffuse bone oedema were also evaluated.Results: MRI was not able to differentiate at the group level between both cohorts on the basis of entheseal‐related disease but a subgroup of PsA patients had diffuse extracapsular enhancement (30%) or diffuse bone oedema (20%). The RA patient group had a greater degree of MCP synovitis (p<0.0001) and tenosynovitis than PsA patients (p<0.0001). There were no significant differences in either the total number of erosions (p = 0.315) or the presence of periarticular bone oedema (p = 0.105) between the groups.Conclusion: Although conventional MRI shows evidence of an enthesitis‐associated pathology in the MCP joints in PsA, this is not sufficiently common to be of diagnostic utility.

Evidence for a different anatomic basis for joint disease localization in polymyalgia rheumatica in comparison with rheumatoid arthritis

The anatomic basis for joint disease localization in polymyalgia rheumatica (PMR) is poorly understood. This study used contrast-enhanced and fat suppression magnetic resonance imaging (MRI) to evaluate the relationship between synovial and extracapsular inflammation in PMR and early rheumatoid arthritis (RA). Ten patients with new-onset PMR and 10 patients with early RA underwent dynamic contrast-enhanced MRI and conventional MRI of affected metacarpophalangeal (MCP) joints. Synovitis and tenosynovitis were calculated based on the number of enhancing voxels, initial rate of enhancement, and maximal enhancement of gadolinium diethylenetriaminepentaacetic acid (Gd-DTPA). Periarticular bone erosion and bone edema were scored according to the OMERACT (Outcome Measures in Rheumatology Clinical Trials) scoring system in both groups. The degree of extracapsular Gd-DTPA enhancement was assessed in both conditions using semiquantitative scoring. No significant differences were seen in the volume of synovitis (P = 0.294), degree of flexor tenosynovitis (P = 0.532), periarticular erosions (P = 0.579), or degree of bone edema (P = 0.143) between RA and PMR joints. However, despite comparable degrees of synovitis, the proportion of MCP joints showing extracapsular enhancement was higher in the PMR group (100%) than in the RA group (50%) (P = 0.030). One PMR patient, but none of the RA patients, had bone edema at the capsular insertion. Despite degrees of synovitis and tenosynovitis comparable with those in RA, PMR-related hand disease is associated with prominent extracapsular changes, suggesting that inflammation in these tissues is more prominent than joint synovitis, which is common in both conditions. This suggests that the anatomic basis for joint disease localization differs between RA and PMR.

Minimal disease activity, remission, and the long‐term outcomes of rheumatoid arthritis

To determine the prevalence of minimal disease activity (MDA) and remission in patients with rheumatoid arthritis (RA), to assess the effect of anti-tumor necrosis factor (anti-TNF) therapy on MDA, and to determine the extent to which MDA status improves long-term outcomes. Using the Patient Activity Scale (PAS) as a surrogate, we assessed the prevalence of MDA and remission in 18,062 patients with RA using the newly developed Outcome Measures in Rheumatology Clinical Trials (OMERACT) criteria for MDA. MDA was noted in 20.2% of 18,062 patients and persistent MDA, operationally defined as having MDA during >or=2 consecutive 6-month observation periods, occurred in 13.5% of 7,433 patients followed longitudinally. Disease activity at remission levels was noted in 7%. Among patients with MDA, 82% received disease-modifying antirheumatic drugs or biologic agents. Following anti-TNF initiation, the cumulative probability of achieving MDA at 2 and 6 years was 4.1% and 7.6%, respectively, and persistent MDA probabilities were 2.7% and 4.5%, respectively. Regardless of RA duration, patients with MDA had substantially better outcomes, including a 10-fold reduction in work disability and an approximately 2-fold reduction in total joint replacement and mortality. Remission remains uncommon in RA, and the prevalence of new remission in community practice is substantially lower than noted in published trials of biologic therapy. On average, persons with MDA appear to have persistently mild RA. This might be the effect of milder RA and/or more effective treatment in early RA. The PAS had satisfactory levels of agreement with the full MDA criteria and appears suitable for use in clinical and epidemiologic research.

Imaging study scores for ankylosing spondylitis

Scoring systems have been developed for radiographs and magnetic resonance imaging (MRI) in patients with ankylosing spondylitis (AS). Radiographic scores focus on chronic structural alterations, which occur slowly and show little sensitivity to change in the short-term. Recent clinical studies used the modified Stoke ankylosing spondylitis spine score (mSASSS), which evaluates the cervical and lumbar spine. TNF antagonists were found to modify the mSASSS, indirectly supporting a structural effect of these agents. MRI using specific sequences is a potent tool for evaluating inflammation, most notably at the spine. MRI has proved sensitive to change in patients taking TNF antagonists. An outcome measures in rheumatology clinical trials (OMERACT) task force is working on standardizing MRI scores for the spine and sacroiliac joints.

Systemische Sklerose – Diagnose und Klassifikation

Systemic sclerosis (SSc) is a polymorphic and heterogenic systemic disorder with inflammation, fibrosis and vascular damage. Early diagnosis and classification may be difficult if disease expression is oligosymptomatic (undifferentiated), presenting with only Raynaud's phenomenon or limited scleroderma. Scleroderma specific antinuclear autoantibodies, which are present early and persistently in about 90% of the patients with SSc, play an important taxonomic role. Scleroderma specific findings in nailfold capillary microscopy are sensitive and predictive for evolving SSc. An algorithm will be presented for the diagnosis and classification of SSc using clinical, capillaroscopic and serologic criteria, which are also useful for mixed or special forms of SSc. The 6th Outcome Measures in Rheumatology Clinical Trials (OMERACT) conference proposed different outcome measurements for clinical studies, however, for daily clinical practice there is as yet no consensus on status indices for disease activity, disease related damage or suitable prognostic criteria.

WITHDRAWN: Non-aspirin, non-steroidal anti-inflammatory drugs for treating osteoarthritis of the knee.

Reason for withdrawal from publication Review has been withdrawn until an update can be undertaken to reflect the current evidence. To view the published versions of this article, please click the 'Other versions' tab.

Patient-Reported Pain is Central to OMERACT Rheumatology Core Measurement Sets

This article provides evidence from the OMERACT (Outcome Measures in RheumAtology Clinical Trials) consensus conferences on patient-reported pain as a key outcome measure for most rheumatologic diseases, including rheumatoid arthritis, osteoarthritis, osteoporosis, back disorders, ankylosing spondylitis, and lupus. These core sets have been endorsed internationally by the World Health Organization, the International League Against Rheumatism, the US National Osteoporosis Foundation, and the OsteoArthritis Research Society International (OARSI). Future research will assess methods for improving interpretability of pain outcomes for patients and clinicians. These methods include determining minimal clinically important differences and number needed to treat (NNT) for continuous outcomes such as pain.