Evaluation of the clinimetric properties of the Early Inflammatory Arthritis--self-administered comorbidity questionnaire.

OBJECTIVES: To adapt the self-administered comorbidity questionnaire (SCQ) into the Early Inflammatory Arthritis-SCQ (EIA-SCQ) and assess its clinimetric properties in EIA. METHODS: The EIA-SCQ and indices of disease activity, function, pain, health-related quality of life (HRQoL) and health resource utilization were administered to 320 patients with EIA. Twenty patients completed the EIA-SCQ a second time 1 week later. Construct validity was evaluated by testing the hypotheses that a valid comorbidity index would correlate well with age, weakly with HRQoL and recent resource utilization and poorly with indices of disease activity, function and pain. RESULTS: The intra-class correlation coefficient between repeat scores was 0.93 (95% CI 0.83-0.97). Kappa values for individual items ranged from 0.64 to 1.0. EIA-SCQ scores correlated moderately with age (Tau B = 0.29, P < 0.001) and weakly with function (HAQ-DI Tau B = 0.09, P = 0.03), pain (McGill Pain Questionnaire Tau B = 0.09, P = 0.05), some measures of HRQoL [the SF-36 mental component score (MCS) Tau B = - 0.08, P < 0.05; World Health Organization Disease Assessment Schedule II score Tau B = 0.09, P = 0.03] and a measure of resource utilization (number of tests in the last 4 months Tau B = 0.10, P = 0.04). The EIA-SCQ did not correlate with other measures of disease activity, another HRQoL measure [SF-36 physical component score (PCS)] or other measures of resource utilization. CONCLUSIONS: The EIA-SCQ is reliable and valid for use in EIA. It has the potential to become a useful measure of comorbidity in outcome studies of EIA when the resources for a full medical chart review are unavailable.

Patients with scleroderma may have increased risk of osteoporosis. A comparison to rheumatoid arthritis and noninflammatory musculoskeletal conditions.

OBJECTIVE: To investigate if subjects with scleroderma (systemic sclerosis, SSc) have increased risk for developing osteoporosis (OP). METHODS: A survey assessing demographics, diagnosis/investigations for OP, and risk factors for OP was mailed to 129 patients with SSc, 158 controls with noninflammatory musculoskeletal (MSK) disease, and 230 positive controls with rheumatoid arthritis (RA). All available charts were reviewed and results were included in analyses of demographics, OP status, past bone mineral density (BMD), and past steroid use. In addition, we recorded BMD results (T score) of SSc patients with their matched RA controls. Analyses adjusted for age were done for SSc versus MSK and SSc versus RA. RESULTS: The response rate was 61% for patients with SSc (n = 28 diffuse, 51 limited disease), RA 67%, and MSK 59%; however, through chart review, 159 SSc, 140 MSK, and 235 RA patients were included in the analyses. Mean age and proportion of women did not differ between groups. Disease duration was longer in RA versus SSc group (16.5 vs 11.5 yrs; p < 0.0001). The prevalence of OP in SSc was similar to RA controls (19.4% vs 16.7%; p = 0.38) but likely higher than MSK controls (12.2%; p = 0.054). Subjects with SSc reported a higher rate of disability (41.0% vs 15.6%; p = 0.0001) and less family history of OP (22.8% vs 46.7%; p = 0.0006) compared with the MSK control group. There were no differences between groups in reports of fracture (35% SSc, 43% MSK, 37% RA; p = 0.5) or OP related fractures (4% SSc, 11% MSK, 11% RA; p = 0.5). Subjects with SSc were less likely to have had a BMD done in the past compared to RA (40.9% vs 62.6%; p = 0.0001). Subjects with RA who reported OP had longer disease duration than RA without OP (18 +/- 1.7 yrs vs 12 +/- 0.8; p = 0.0009). Results from the chart review showed that the T scores of SSc (n = 56, mean age 62.9 +/- SD 10.1 yrs) at lumbar spine (SSc -1.01 vs RA -0.97), femoral neck (SSc -2.07 vs RA -1.46; p = 0.01, adjusting for age p = 0.26), and total hip region (SSc -1.52 vs RA -1.25) were comparable to or even lower than the RA group (n = 56, mean age 62.2 +/- SD 10.7 yrs). CONCLUSION: The prevalence of OP in patients with SSc was comparable to those with RA, but higher than in the MSK group. Age was found to be an important factor, as expected. Also, our results indicated that BMD (T score) in SSc was similar to or even lower than in patients with RA. Increasing the awareness to order BMD measurements in patients with SSc may be warranted based on our results, especially for older patients.

Assessment of unmet needs and the lack of generalizability in the design of randomized controlled trials for scleroderma treatment.

OBJECTIVE: To determine the generalizability of randomized controlled trials (RCTs) in the treatment of systemic sclerosis (SSc) using the Canadian Scleroderma Research Group (CSRG) database. METHODS: We identified articles related to SSc published from 1958 to 2006. Key points on trial design were recorded. The inclusion/exclusion criteria were used in conjunction with the CSRG database to determine the proportion of patients with SSc who would theoretically be eligible for these trials. Articles were classified into subcategories according to the target system. The CSRG database contains 438 patients with SSc from 14 Canadian centers. Results were in median (%) and mean (%) with 95% confidence intervals (95% CIs). RESULTS: In total, 210 articles were evaluated and 73 were selected for inclusion in this study. The mean percentage of eligible patients with SSc associated with other conditions was 35% (95% CI 17-53) for Raynaud's phenomenon, 24% (95% CI 1-47) for digital ulcers, 48% (95% CI 27-68) for gastrointestinal (GI) involvement, 32% (95% CI 20-43) for overall disease modification, 6% (95% CI 4-8) for pulmonary arterial hypertension, 2% (95% CI 0-4) for interstitial lung disease, and 38% (95% CI 12-64) for other categories. CONCLUSION: Except for GI trials, <38% of the identified patients with SSc would have been suitable to enter the RCTs. Although some patients would be ineligible because they lack certain organ involvement, RCTs designed to include appropriate patients with SSc are needed; there are few proven treatments and trials typically do not include the majority of those who could potentially benefit from the intervention.