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Objective.Systematic reviews often struggle with how to combine information when more than 1 instrument is used across studies being synthesized. Different techniques have been suggested based on frequency of use in the literature, or on consensus. We explore an approach blending 2 initiatives: OMERACT (Outcome Measurement in Rheumatology) and COSMIN (Consensus On Selection of Measurement Instruments), and investigate the effects of an evidence-based measurement approach on selection of outcomes.Methods.Readings were circulated to attendees registered for a preconference workshop on pain measurement. Three instruments were considered and exercises conducted to engage people in the content and measurement performance of these tools. Consensus was sought that an evidence-based approach could be created for selection of instruments for summary of findings (SoF) tables.Results.The blending of COSMIN and OMERACT approaches led to an evidence-based approach that depended both on a clear definition of target concept and a review of measurement performance of the instrument. Participants emphasized that conceptual clarity and practical considerations should come before measurement property results.Conclusion.Evidence-based approaches can be adopted for selection of instruments for SoF tables. A research agenda was formulated.

Objective.Administrative data are increasingly being used for research and surveillance about rheumatic diseases. However, literature reviews have revealed a lack of consistency in methods for conducting observational rheumatic disease studies, a situation that can lead to findings that cannot be compared. Our purpose was to develop best-practice consensus statements about the use of administrative data for rheumatic disease research and surveillance in Canada.Methods.We convened 52 decision makers, epidemiologists, clinicians, and researchers to a 2-day workshop. Prior to this, participants formed working groups to examine 3 best-practice categories: case definitions, epidemiology methods, and comorbidity and outcomes measurement. The groups conducted systematic or scoping reviews on key topics. At the workshop, evidence from the reviews was presented and consensus-building techniques were used to develop the best-practice statements. The statements were presented, discussed, revised (as needed), and then subjected to voting.Results.Thirteen best-practice consensus statements were developed and endorsed by consensus. For the first category, these consensus statements addressed validation techniques for rheumatic disease case definitions and case ascertainment bias. The consensus statements for epidemiology methods focused on confounding and drug exposure measurement. For comorbidity and outcomes measurement, consensus statements were developed for multiple conditions, including osteoporosis and fragility fractures, cancer, infections, cardiovascular disease, and renal disease. Strengths and limitations of administrative data were identified in relation to each topic.Conclusion.Our best-practice consensus statements are consistent with other recent guidelines, including those for rheumatic disease biologics registries, but address additional issues specific to administrative data. Continuing work focuses on disseminating these consensus statements to multiple audiences.

OBJECTIVE: To compare live birth rates in women with recurrent pregnancy loss (RPL) and either autoantibodies or a coagulation abnormality, treated with low molecular weight heparin plus aspirin (LMWH/ASA) or ASA alone, and to place our results in context with other randomized clinical trials (RCT) with similar cohorts. METHODS: The HepASA Trial was an RCT including patients with a history of RPL and at least 1 of the following: antiphospholipid antibody (aPL), an inherited thrombophilia, or antinuclear antibody. Treatment groups were stratified by aPL status and history of early versus late pregnancy losses. Patients received either LMWH/ASA or ASA alone. The primary outcome was live birth; secondary outcomes included adverse events and bone loss at the spine and femoral neck. Literature over the past 20 years was reviewed to identify comparable RCT. RESULTS: Over 4 years, 859 women with RPL were screened: 88 (10.2%) fulfilled inclusion criteria, became pregnant and were randomized to receive either LMWH/ASA or ASA alone. aPL were present in 42 (47.7%) patients in each group. The trial was stopped after 4 years when an interim analysis showed no difference in live birth rates in the 2 groups, and a lower rate of pregnancy loss in the ASA only group than expected. In the LMWH/ASA group, 35/45 (77.8%) had a live birth versus 34/43 (79.1%) in the ASA only group (p = 0.71). Neither number of prior losses nor aPL status was correlated with pregnancy outcome. There were no cases of pregnancy related thrombosis in either group. Mean change in BMD did not differ by treatment group at either the lumbar spine (p = 0.57) or femoral neck (p = 0.15). RCT since 2000 for aPL positive women with RPL and similar inclusion criteria report a mean live birth rate of 75% with either LMWH or ASA. CONCLUSION: LMWH/ASA did not confer incremental benefit compared to ASA alone for this population. Regardless of treatment regimen, number of prior losses, or aPL positivity, almost 80% of women in our RPL cohort had a successful pregnancy outcome. These findings contribute to a growing body of literature that contests the emerging standard of care comprising LMWH/ASA for this population.

OBJECTIVE: The intent of this cross-sectional study was to broaden the range of variables examined in relationship to depression in osteoarthritis (OA) to include comorbidity, stressful life events, and the ways people respond to their disease. We examined the relationship of coping behaviors and perceptions, and medical treatments received for OA and depressive symptoms. METHODS: In the fifth year of a prospective cohort study, 1227 individuals ≥ 62 years of age with hip/knee OA provided information about sociodemographics (age, sex, living circumstances, education), arthritis severity (WOMAC pain and function; ClinHAQ fatigue), comorbidity, life events, coping behavior, coping efficacy, treatment (pain management, treatment for depression), and depressed mood (Centre for Epidemiological Studies Depression scale, CES-D). Using hierarchical linear regression, variables were entered in blocks to predict CES-D scores. In the final block, the interaction of coping behavior and coping efficacy was tested. RESULTS: The response rate was 82.4% (n = 1227/1489). The mean CES-D score was 9.4, with 21.3% of individuals scoring ≥ 16 (supporting depressed mood). Higher level of depressed mood was independently and significantly associated with being female, experiencing greater pain and fatigue, experiencing stressful life events, more coping behaviors, receiving treatment for depression/mental illness, and a coping behavior by coping efficacy interaction, with 63.4% of the variance accounted for in the model. CONCLUSION: Among older adults with OA, the prevalence of depressive symptoms is high. Longitudinal studies must consider OA management strategies, including both the amount of behavioral coping and its perceived efficacy, to elucidate potential interventions designed to reduce depression in patients with OA.

OBJECTIVE: To evaluate the measurement properties of criteria for systemic sclerosis (SSc) subsets for classification of patients in SSc trials, and to determine if any one criteria set confers measurement advantage over others. METHODS: A systematic review of articles describing classification criteria for SSc subsets was performed. Evidence supporting the sensibility (statement of purpose for which the criteria will be used, population, setting, face and content validity, and feasibility), validity, and reliability of the criteria was evaluated. RESULTS: Fourteen sets of criteria for SSc subsets were identified. There is variability in the intended purpose and setting for which criteria sets are to be applied. Although face validity improves with the addition of less commonly encountered subsets or disease manifestations as criteria, the feasibility of implementing such criteria is conversely limited. Content validity for most criteria sets has not been evaluated due to lack of an explicitly stated conceptual framework for SSc. The criteria with 3 or more subsets do not provide incremental predictive validity over the 2-subset criteria. Our ability to compare subset criteria on divergent validity and reliability is limited by a lack of data. CONCLUSION: The 2-subset criteria of LeRoy, et al have good feasibility, acceptable face validity, and good predictive validity. Further research is needed to compare the content validity, divergent validity, and reliability of these with other subset criteria for use in SSc trials.

OBJECTIVE: Time to theoretical indication of joint replacement surgery has been proposed as a primary outcome for potential structure-modifying interventions for osteoarthritis (OA). The objectives of this OMERACT/OARSI Working Group were to identify pain, physical function, and structure states that represent the progression from early to late disease for individuals with OA of the hip and knee, and to create a composite measure of these 3 domains to define states of OA severity and a surrogate measure of "need for joint replacement surgery." METHODS: For pain, focus groups and one-on-one interviews were used. For function, Rasch analysis was performed on existing indices — the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) and the Knee injury and Osteoarthritis Outcome Score (KOOS), each of which subsumes the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questions. For structure, a comparison of existing indices (Kellgren-Lawrence, OARSI stages, and joint space width) was performed for the hip and the knee. RESULTS: For pain, key features of pain that are most distressing to people with OA from early to late disease were identified. For function, the reduction of the number of items based on the existing indices continues. For structure, the analysis is also ongoing. CONCLUSION: Preliminary results were presented at OMERACT 8; the final objective will be to combine the 3 domains (pain, function, and structure) and to create a composite index that could define states of severity and "need for total joint replacement," which could be used to evaluate treatment response to disease-modifying drugs in OA clinical trials.

OBJECTIVE: Rofecoxib was recalled in September 2004 when studies identified increased cardiovascular risk compared with placebo among patients taking rofecoxib. We examined the reactions of people with arthritis to this recall. METHODS: Telephone interviews were conducted between December 2004 and February 2005 in a previously assembled community based cohort (n = 1085) with disabling hip/knee osteoarthritis (OA) residing in 2 regions of Ontario, Canada (one urban, one rural). Respondents' self-reported experience with cyclooxygenase (COX-2) selective nonsteroidal antiinflammatory drugs (NSAID; coxibs), issues around communication of the recall, attitudes about pain medications, and understanding of the rofecoxib-associated cardiovascular risks were assessed. Participants were also asked about contraindications for traditional NSAID use (specific clinical conditions, use of blood thinners and glucocorticoids, and history of gastrointestinal (GI) ulcer and/or bleeding). RESULTS: The response rate was 93.5%; 968 completed the survey. Half (53.0%) had used a coxib for arthritis; 277 (28.6%) had used rofecoxib. Only 3.8% of "ever" coxib users reported previous GI ulcer or hemorrhage. 94.8% of respondents had heard about the recall; most (94.7%) had heard via television. Among the 83 individuals taking rofecoxib at recall, 90.4% had been offered another pain medication, mainly another coxib. Most of the 968 participants (> 60%) were unfamiliar with rofecoxib-associated cardiovascular risks. Of those with an opinion, most overestimated the absolute risk associated with rofecoxib (55.7% cited a risk > 5 events/100 people/year). CONCLUSION: In an elderly community cohort with OA, the prevalence of coxib use was high despite few major contraindications to NSAID. Many were unaware of or overestimated the absolute risks associated with rofecoxib use, highlighting the need for strategies by which physicians/pharmacists can provide their patients with timely and accurate drug safety information.

OBJECTIVE: To estimate the prevalence of self-reported osteoporotic fractures and use of bone-sparing agents, and to examine if region of residence is associated with fracture or treatment prevalence. METHODS: A census of persons aged ≥ 55 years residing in 2 regions of Ontario, Canada (East York, a region within Toronto, and Oxford County), was completed between 1995 and 1998. Region was coded by record linkage of residential postal codes to 1996 Canadian Census data into 4 groups: East York (urban core), and Oxford County subdivided into: urban core, small urban, and rural. Respondents were excluded if they resided outside the regions of interest or were missing fracture data (5%). RESULTS: A total of 26,839 persons (15,541 women) were studied. Nearly 3 times as many women as men reported having had an osteoporotic fracture (14% vs 5%), with 31% and 8%, respectively, taking bone-sparing agents. Controlling for age, a diagnosis of osteoporosis, number of osteoporotic fractures, and height loss, women residing in East York were more likely (OR 1.2, 95% CI 1.0–1.4) to be taking a bone-sparing agent other than estrogen, but less likely to be taking estrogen (OR 0.8, 95% CI 0.7–0.9) compared to those living in rural areas. No regional differences were observed in fracture prevalence, treatment among those with an osteoporotic fracture, or use of a bone-sparing agent among men. CONCLUSION: Further research into regional differences in osteoporosis screening, treatment, and fractures is warranted. This should examine the appropriateness of possible differences, and separate physician practice patterns from patient characteristics, such as willingness to begin treatment with bone-sparing agents.

OBJECTIVE: Physical therapy (PT) is a recommended treatment for the management of arthritis. We investigated factors related to referral to PT services in people with hip or knee arthritis and describe characteristics of treatment received. METHODS: As part of a longitudinal study of the population aged ≥ 55 years with at least moderately severe hip or knee arthritis in 2 Ontario counties (n = 1350), participants were surveyed in the third year of followup about use of PT. Participants were categorized as to whether they had total joint replacement surgery in the past year (TJR group, n = 52) or did not (non-TJR group, n = 1298). Multivariate logistic regression was used to identify determinants of referral to PT considering sociodemographic characteristics, comorbidity, use of prescribed arthritis medication, and arthritis severity (WOMAC summary score). RESULTS: Overall, 18.7% of the cohort was referred to PT in the past year: 65.4% of the TJR group and 16.8% of the non-TJR group. The only significant predictor of PT in the TJR group was current use of prescribed arthritis medication. Greater arthritis severity, current use of prescribed arthritis medication, and greater comorbidity were significant independent predictors of referral to PT for the non-TJR group in multivariate logistic regression. The Ontario Health Insurance Plan paid for the majority of PT received. CONCLUSION: Low rates of referral to PT in the previous year suggest possible underutilization. Further research is needed to examine patterns of use of PT throughout the course of the arthritis disease process and to examine barriers to PT access.

OBJECTIVE: To determine factors that correlate with recommendations for nonpharmacologic and pharmacologic interventions (comprehensive therapy) in community dwelling adults. METHODS: Eligible participants were ≥ 55 years of age with hip and knee arthritis symptoms and disability. Comprehensive therapy was classified as a recommendation for exercise and weight loss (if required) and any pharmacotherapy. RESULTS: Only one-half of participants received a recommendation for comprehensive therapy. Participants who had seen a specialist and a therapist were almost twice as likely to receive a recommendation for comprehensive therapy. CONCLUSION: In our setting, many people with hip or knee arthritis were not receiving even minimum recommended treatment. Changes in educational and organizational policies are needed to address this situation.

OBJECTIVE: To determine what, if any, barriers exist that prevent rheumatologists from providing adequate rheumatology care. METHODS: All 158 identified rheumatologists in Ontario were sent a self-administered questionnaire and followed up by telephone. RESULTS: The response rate was 83%. All but 6 rheumatologists reported at least one barrier to the provision of service. The 3 most commonly reported barriers were the cost of drugs for patients (83%), billing policies and regulations for consultation and followup visits (72%), and long waiting times for patients (61%). Rheumatologists reporting the latter had significantly longer waiting times (12 vs 4 wks) for new non-urgent patients, although there was no difference for new patients with inflammatory arthritis. Nearly three-quarters of respondents had changed the patterns of their practice over the last 3 years, with significant increases in the amount of independent medical services (e.g., third party billing) and pharmaceutical company work. The majority (89%) of responding rheumatologists reported having at least some difficulty in making ends meet from rheumatology practice alone and 28% found it was not possible. CONCLUSION: These results indicate that the majority of rheumatologists face significant barriers to providing adequate care. Given the recruitment and service provision concerns in Canada, these barriers to service need to be addressed to ensure adequate provision of care.

OBJECTIVE: A disease-modifying osteoarthritic drug (DMOAD) should interfere with the cartilage breakdown observed and improve symptoms or prevent deterioration of the patient’s clinical condition. We propose a composite index including structural and symptomatic variables of osteoarthritis (OA) as criteria for being considered a candidate for total joint replacement as an endpoint in clinical trials evaluating potential DMOAD. METHODS: An OARSI/OMERACT task force conducted this study in 3 steps: (1) The 3 main domains — pain, function, structure — were revisited; (2) For each of the domains a "non-acceptable state" and a "relevant" progression for their structure were defined; and (3) a set of criteria was proposed combining the information from these 3 domains. RESULTS: A questionnaire was elaborated for the domains "pain" and "function." Systematic research of the literature and evaluation of different databases concluded that the domain "structure" should be evaluated by radiological joint space width in millimeters. An unacceptable radiographic progression was defined as a change in the joint space width over the measurement error. An international, cross-sectional study is proposing a definition of a "nonacceptable symptom state." CONCLUSION: The objective of the ongoing OARSI/OMERACT initiative is to propose criteria for being considered a candidate for total joint replacement to be used as an endpoint in clinical trials evaluating potential DMOAD. The preliminary steps of this initiative have been completed.

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."