Published data indicate that the risk of incident CVD is increased by 48% in patients with RA compared to the general population. Sample and cohort type influenced the estimates of RR.
Objective-To estimate the minimal clinically important difference (MCID) of seven measures of fatigue in rheumatoid arthritis.Study Design and Setting-A cross-sectional study design based on inter-individual comparisons was used. Six to eight subjects participated in a single meeting and completed seven fatigue questionnaires (nine sessions were organized and 61 subjects participated). After completion of the questionnaires, the subjects had five one-on-one 10-minute conversations with different people in the group to discuss their fatigue. After each conversation, each patient compared their fatigue to their conversational partner's on a global rating. Ratings were compared to the scores of the fatigue measures to estimate the MCID. Both non-parametric and linear regression analyses were used.Results-Non-parametric estimates for the MCID relative to "little more fatigue" tended to be smaller than those for "little less fatigue". The global MCIDs estimated by linear regression were: FSS 20.2, VT 14.8, MAF 18.7, MFI 16.6, CFS 9.9, RS 19.7, for normalized scores (0 to 100). The standardized MCIDs for the seven measures were roughly similar (0.67 to 0.76). Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Fatigue is a non-specific subjective symptom. In the absence of an objective measurement, fatigue can only be assessed by asking the subject. The measurement properties of available instruments need to be evaluated if they are to be used clinically or in clinical trials. Among the psychometric properties, longitudinal validity (responsiveness, sensitivity to change) is one of the most important. Closely related is the minimal clinically important difference (MCID), which is defined as "the smallest difference in score in the domain of interest (fatigue) which patients perceive as beneficial and which would mandate, in the absence of troublesome side effects and excessive cost, a change in the patient's management" [9]. The MCID is essential to interpret the magnitude of longitudinal changes or differences when comparing two treatments or different group of patients. Knowledge of MCID is also essential for meaningful sample size calculations in clinical trials. NIH Public AccessThe aim of our study was to estimate the MCID of seven validated self-administered measures of fatigue in persons with RA. The fatigue instruments identified from a literature review as suitable for use in RA and studied were: the Fatigue Severity Scale (FSS) [10,11] Patients and Methods PatientsThe study was conducted at the Mary Pack Arthritis Centre, Vancouver, Canada. All participants signe...
Objective. To evaluate the efficacy and safety of adding intramuscular (IM) gold to the treatment regimen of patients with rheumatoid arthritis (RA) who have a suboptimal response to methotrexate (MTX).Methods. A randomized, double-blind, doubleobserver, placebo-controlled multicenter trial of 48 weeks was conducted. Sixty-five RA patients who had a suboptimal response to >12 weeks of MTX therapy were randomly assigned to receive weekly IM gold or placebo in addition to MTX. Gold was administered according to a standard protocol developed for the study. The primary outcome measure was the percentage of patients who met the American College of Rheumatology (ACR) 20% improvement criteria (achieved an ACR20 response) at week 48. Secondary outcomes included the percentages of patients achieving ACR50 and ACR70 responses, the individual criteria that make up the primary outcome, quality of life, direct and indirect health care costs, intraarticular steroid use, and adverse events, among other measures. Statistical analyses were based on an intent-to-treat strategy.Results. Sixty-one percent of patients receiving gold achieved an ACR20 response compared with 30% of patients receiving placebo ( 2 ؍ 6.04, P ؍ 0.014; logistic regression odds ratio 3.64 [95% confidence interval 1.3, 10.4], P ؍ 0.016). Twenty-six percent of patients receiving gold achieved an ACR50 response compared with 4% of patients receiving placebo (P ؍ 0.017), and 21% of patients receiving gold achieved an ACR70 response compared with 0% of patients receiving placebo (P ؍ 0.011). From both clinical and cost-effectiveness perspectives, gold was the preferred and dominant strategy. Study treatment was discontinued in 23 patients (14 in the placebo group compared with 9 in the gold group; P ؍ 0.022) due to loss to followup, adverse events, or lack of efficacy.Conclusion. In RA patients with a suboptimal response to MTX, adding weekly IM gold causes significant clinical improvement. Adverse events were minor, and IM gold-related adverse events led to discontinuation in only 11% of the gold group over 48 weeks.Rheumatoid arthritis (RA) affects ϳ1% of North Americans, with profound impact on their quality of life (1) as well as economic consequences for them, their
Objective. To determine whether perceptions of clinical manifestations (fatigue, pain, and physical limitation) of rheumatoid arthritis (RA) differ between spouses and their partners with RA, and to determine whether the differences are associated with the perception of beneficial and problematic spousal social support. Methods. English-speaking adults with RA of >6 months' duration and their spouses (n ؍ 222 couples) completed standardized questionnaires for fatigue, pain, physical limitation, beneficial spousal support, and problematic spousal support. Spouses completed questionnaires based on their perception of their partner with RA. Agreement scores for fatigue, pain, and physical limitation were calculated by subtracting spouse scores from the scores of the partner with RA. Agreement levels were defined a priori: agreement (within ؎ one-half of a minimum clinically important difference [MCID] unit), overestimator (< one-half an MCID), and underestimator (> one-half an MCID). Separate hierarchical linear regression models were used to measure the association between beneficial support and problematic support after adjusting for RA duration, physical health, sex, educational level, relationship duration, and satisfaction. Results. Response rate for couples was 82%. Relative to participants with RA, spouses overestimated fatigue (26%), pain (29%), and physical limitation (39%), and underestimated fatigue (11%), pain (17%), and physical limitation (34%). After statistically controlling for demographic, disease, and psychosocial variables, participants with RA whose spouses underestimated fatigue received more problematic support (R 2 ؍ 3.7%, P ؍ 0.002), as did those whose spouses underestimated or overestimated physical limitation (R 2 ؍ 3.4%, P ؍ 0.017). Conclusion. Persons with RA perceived more problematic spousal support when their spouse underestimated fatigue, or underestimated or overestimated physical limitation levels.
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