Objective: To assess changes in health status of women with fibromyalgia (FM) over 5 years and determine whether baseline employment status influences health outcomes adjusting for other baseline factors.
Methods: Two hundred eighty-seven women with FM were recruited from a national sample of rheumatologists and interviewed by phone at baseline and annually for 4 years. Data were collected on pain, fatigue, Center for Epidemiologic Studies Depression Scale and Modified Health Assessment Questionnaire (M-HAQ) scores, demographic characteristics, and employment status. At the end of the study, 211 participants remained. Data were analyzed using multilevel modeling techniques. Bootstrap methods adjusted for the cluster sampling.
Results: The participants' mean +/- SD age was 47 +/- 11 years, their mean +/- SD education level was 14 +/- 2 years, 90% were white, 50% employed, 64% married, and their median household income was >or=$50,000. Mean +/- SD scores at baseline were 57.2 +/- 24 for pain, 75.4 +/- 22 for fatigue, 22.9 +/- 13 for depression, and 0.73 +/- 0.5 for the M-HAQ. Multilevel modeling indicated that all health status measures declined significantly over time except for pain. Rates of change varied from -1.22 for fatigue to -0.03 for the M-HAQ. Except for pain, patients who were employed at baseline had better health status over time. The employment and time interaction was not significant, indicating that health status changed at the same rate regardless of employment status. Other significant factors were age and income.
Conclusion: Employed women with FM have better health status at baseline and maintain that advantage over time. Employment does not seem to provide a protective health benefit.
Objective: To describe changes in outcome measures in patients with knee and hip osteoarthritis (OA) over 2 years according to the International Classification of Functioning, Disability and Health, and to evaluate the sensitivity to change of available outcome instruments.
Methods: A total of 115 symptomatic knee or hip OA patients (mean age 60.0 years, 80% women) were followed for 2 years. Standardized knee and hip radiographs were scored for joint space narrowing (JSN) using the Osteoarthritis Research Society International Atlas. Pain intensity in knees and hips was graded during physical examination. Self-reported pain and functioning were assessed with the Western Ontario and McMaster Universities OA Index (WOMAC). Social functioning was assessed with social functioning scores of the RAND 36-item Health Survey. Standardized response means (SRMs) were calculated to evaluate sensitivity to change.
Results: Substantial increases in JSN and pain intensity total scores over 2 years were observed (SRMs 0.43 and 0.41, respectively). Twenty-three percent of patients had an increase of at least 1 point in JSN total scores. An increase in pain intensity total scores was present in 46% of patients, whereas a decrease was observed in 19.1.% of patients. WOMAC pain and function scores showed small increases (SRMs 0.15 and 0.18, respectively). No change was seen in social functioning scores (SRM 0.01).
Conclusion: Objective instruments measuring impairment in body structures and function are more sensitive to change over 2 years in patients with OA than self-reported measurements of impairment in body function, activity limitation, and participation restriction. These findings encourage development of new instruments to improve measurement of disease outcome in OA.
Objective: To assess the potential benefits of methotrexate in patients with systemic lupus erythematosus (SLE).
Methods: A 12-month, double-blind, placebo-controlled trial of methotrexate with folic acid was conducted. Intent-to-treat analyses were performed with mixed linear models and alpha = 0.04 (96% confidence interval [96% CI]) to account for interim analysis of longitudinal data to assess the treatment effects on lupus disease activity and daily steroid dose across monthly measurements, and to test if the treatment effects depended on selected participant characteristics.
Results: Of 215 participants screened, 94 were excluded, 35 declined, and 86 were randomized (methotrexate = 41, placebo = 45). The groups were balanced for demographic and disease characteristics. Antimalarial use was more frequent in the placebo group, which was adjusted for in multivariable analyses. Sixty participants (27 methotrexate, 33 placebo) completed the study and 26 terminated early. Among participants who had the same baseline prednisone dose, those taking methotrexate received, on average, 1.33 mg/day less prednisone during the trial period (96% CI 0.06, 2.72 mg/day; a 22% reduction of their average-during-trial daily dose) compared with those in the placebo group. For the primary measure of disease activity (revised Systemic Lupus Activity Measure), methotrexate use was also associated with a marginally significant reduction in the mean during-trial score of 0.86 units (96% CI 0.01, 1.71; P = 0.039). A significant interaction between treatment and baseline damage was found (P = 0.001).
Conclusion: Methotrexate conferred a significant advantage in participants with moderately active lupus by lowering daily prednisone dose and slightly decreasing lupus disease activity. As a therapeutic option in moderate SLE, methotrexate can be considered to be steroid sparing.
Objective: To study muscle strength and functional performance in patients with anterior cruciate ligament (ACL) injury with or without surgical reconstruction 2 to 5 years after injury. Good muscle function is important in preventing early-onset osteoarthritis (OA), but the role of reconstructive surgery in restoring muscle function is unclear.
Methods: Of 121 patients with ACL injury included in a randomized controlled trial on training and surgical reconstruction versus training only (the Knee, Anterior cruciate ligament, NON-surgical versus surgical treatment [KANON] study, ISRCTN: 84752559), 54 (mean age at followup 30 years, range 20-39, 28% women) were assessed a mean +/- SD of 3 +/- 0.9 years after injury with reliable, valid, and responsive test batteries for strength (knee extension, knee flexion, leg press) and hop performance (vertical jump, one-leg hop, side hop). The Limb Symmetry Index (LSI; injured leg divided by uninjured and multiplied by 100) value and absolute values were used for comparisons between groups (analysis of variance). An LSI >or=90% was considered normal.
Results: There were no differences between the surgical and nonsurgical treatment groups in muscle strength or functional performance. Between 44% and 89% of subjects had normal muscle function in the single tests, and between 44% and 56% had normal function in the test batteries.
Conclusion: The lack of differences between patients treated with training and surgical reconstruction or training only indicates that reconstructive surgery is not a prerequisite for restoring muscle function. Abnormal muscle function, found in approximately one-third or more of the patients, may be a predictor of future knee OA.
Objective: To investigate the relationship of fatigue severity to other clinical features in primary Sjögren's syndrome (SS) and to identify factors contributing to the physical and mental aspects of fatigue.
Methods: We identified 94 subjects who met the American-European Consensus Group criteria for the classification of primary SS. Fatigue was assessed with a visual analog scale, the Fatigue Severity Scale (FSS), and the Profile of Fatigue (ProF). Associations with fatigue were compared using multivariate regression.
Results: Abnormal fatigue, defined as an FSS score >or=4, was present in 67% of the subjects. Pain, helplessness, and depression were the strongest predictors of fatigue according to the FSS and the somatic fatigue domain of the ProF (ProF-S), both with and without adjustment for physiologic and serologic characteristics. Depression was associated with higher levels of fatigue; however, the majority of subjects with abnormal fatigue were not depressed. Anti-Ro/SSA-positive subjects were no more likely to report fatigue than seronegative subjects. The regression models explained 62% of the variance in FSS and 78% of the variance in ProF-S scores. Mental fatigue was correlated with depression and helplessness, but the model predicted only 54% of the variance in mental fatigue scores.
Conclusion: Psychosocial variables are determinants of fatigue, but only partially account for it. Although fatigue is associated with depression, depression is not the primary cause of fatigue in primary SS. Investigation of the pathophysiologic correlates of physical and mental aspects of fatigue is needed to guide the development of more effective interventions.
Objective: The Health Assessment Questionnaire (HAQ) disability index (DI) is the most common self-reported measure of physical disability in rheumatoid arthritis (RA). Recently, the HAQ-II was developed in the US as a short, valid, and reliable alternative using Rasch analysis. Our objective was to compare the scaling properties of the HAQ DI and HAQ-II in Dutch patients with RA.
Methods: We used data from 472 patients with confirmed RA. Internal construct validity of the HAQ versions was assessed using Rasch analysis. Additionally, external construct validity was assessed by examining correlates with other outcome measures.
Results: The HAQ DI had a large floor effect, with 9.5% of the patients indicating no disability compared with 4.3% for the HAQ-II. Both versions were unidimensional and adequately fit the Rasch model, containing only 1 nonfitting item. Additionally, 2 HAQ-II items demonstrated overfit and a high residual correlation, suggesting overlap or redundancy in item content. The HAQ-II demonstrated better item separation, indicating that it covered a wider range of physical function. Item difficulty estimates were reasonably well spread for the HAQ-II, whereas the HAQ DI items tended to cluster around similar difficulty levels. Both scales contained several items with differential item functioning by sex, age, or disease duration. Both scales demonstrated the expected pattern of correlations with other outcome measures.
Conclusion: The results indicate that both the HAQ DI and HAQ-II are psychometrically robust measures of physical function. The Rasch-developed HAQ-II, however, has several favorable scaling properties, including a better scale length and a reduced floor effect.
Objective: To prospectively examine arthritis-related productivity losses, work changes, and leaving employment, the relationships among these work transitions, and the factors associated with them.
Methods: Participants with inflammatory arthritis or osteoarthritis were interviewed at 4 time points, 18 months apart, using a structured questionnaire. At baseline (T1), all participants (n = 490; 381 women, 109 men) were employed. At T2, T3, and T4, the sample decreased to 413, 372, and 349 participants, respectively. Respondents were recruited using community advertising and from rheumatology and rehabilitation clinics. Work transitions considered were productivity losses (absenteeism, job disruptions), work changes (reduced hours, changing jobs), and leaving employment. Also measured were demographic, illness, work context, and psychological variables. Generalized estimation equations modeled predictors of work transitions over time.
Results: Although 63.1% of respondents remained employed throughout the study, work transitions were common (reported by 76.5% of participants). Productivity losses, especially job disruptions such as being unable to take on extra work, were the most frequently reported. Work transitions were related to subsequently making other work transitions, including leaving employment. Age, sex, education, activity limitations, control, depression, and arthritis-work spillover were also associated with work transitions.
Conclusion: This study sheds light on a process of diverse employment changes that may occur in the lives of many individuals with arthritis. It emphasizes the interrelationships among work transitions, as well as other factors in predicting work transitions, and it provides insight into work changes that may signal impending difficulties with remaining employed.