OBJECTIVE To examine physical activity and achievement of physical activity goals in relation to self-reported pain and quality of life among patients with rheumatoid arthritis (RA). METHODS At... Show moreOBJECTIVE To examine physical activity and achievement of physical activity goals in relation to self-reported pain and quality of life among patients with rheumatoid arthritis (RA). METHODS At baseline, 271 patients with RA were asked to specify a physical activity goal, and filled in questionnaires assessing physical activity, motivation, and self-efficacy for physical activity, arthritis pain, and quality of life. Six months later, patients indicated to what extent they had achieved their baseline physical activity goal and completed the same set of questionnaires. These data were used to construct multiple mediation models that placed physical activity and physical activity goal achievement as mediators between self-efficacy and motivation on one hand, and arthritis pain and quality of life on the other. RESULTS A total of 106 patients with RA completed both questionnaires. Self-efficacy at baseline predicted subsequent level of physical activity and achievement of physical activity goals. Goal achievement had a direct effect upon quality of life outcomes. Bootstrapping confidence intervals revealed indirect effects of self-efficacy upon arthritis pain and quality of life through goal achievement, but not through physical activity. CONCLUSION Higher levels of self-efficacy for physical activity increase the likelihood that patients will achieve their physical activity goals. Achievement of physical activity goals seems to be related to lower self-reported arthritis pain, and higher levels of quality of life. In practice, clinicians can foster self-efficacy and goal achievement by assisting patients in setting realistic and attainable exercise goals, developing action plans, and by providing feedback on goal progress. Show less
Schouffoer, A.A.; Ninaber, M.K.; Beaart-van de Voorde, L.J.J.; Giesen, F.J. van der; Jong, Z. de; Stolk, J.; ... ; Vlieland, T.P.M.V. 2011
Objective. To compare the effectiveness of a multidisciplinary team care program with usual outpatient care in patients with systemic sclerosis (SSc; scleroderma). Methods. We performed a... Show moreObjective. To compare the effectiveness of a multidisciplinary team care program with usual outpatient care in patients with systemic sclerosis (SSc; scleroderma). Methods. We performed a randomized controlled trial comparing a 12-week multidisciplinary team care program (1 day per week; individual treatments, group exercises, and group education) with outpatient clinic care. Outcome measures included the Hand Mobility in Scleroderma (HAMIS) test, grip strength, maximal mouth opening (MMO), 6-minute walk distance (6MWD), maximum aerobic capacity (Vo(2max)), Checklist Individual Strength 20 (CIS-20), SSc Health Assessment Questionnaire (HAQ), and Short Form 36 (SF-36), assessed at 0, 12, and 24 weeks. Statistical comparisons of change scores were done by analysis of covariance. Results. Twenty-eight patients were assigned to the intervention group (mean age 53.9 years, 15 of 28 with diffuse SSc) and 25 were assigned to the control group (mean age 51.7 years, 15 of 25 with diffuse SSc). Twenty-five patients (89%) in the intervention group completed the treatment program. At 12 weeks, there was a significantly greater improvement in grip strength (2.2 versus -1.8 kg; P = 0.001), MMO (1.4 versus -0.9 mm; P = 0.011), 6MWD (42.8 versus 3.9 meters; P = 0.021), and HAQ score (-0.18 versus 0.13; P = 0.025) in the intervention group, whereas differences for the other outcome measures did not reach significance. At 24 weeks, the effect on grip strength persisted. Conclusion. In patients with SSc, a 12-week multidisciplinary day patient treatment program was more effective than regular outpatient care with respect to 6MWD, grip strength, MMO, and HAQ score, but not for Vo(2max), HAMIS test, CIS-20, SF-36, and visual analog scale for pain. This study provides a first step in quantifying the effect of a multidisciplinary team care program and warrants the conduct of further intervention studies. Show less
Schouffoer, A.A.; Ninaber, M.K.; Beaart-van de Voorde, L.J.J.; Giesen, F.J. van der; Jong, Z. de; Stolk, J.; ... ; Vlieland, T.P.M.V. 2011
OBJECTIVE: To compare the effectiveness of a multidisciplinary team care program with usual outpatient care in patients with systemic sclerosis (SSc). METHODS: A randomized controlled trial... Show moreOBJECTIVE: To compare the effectiveness of a multidisciplinary team care program with usual outpatient care in patients with systemic sclerosis (SSc). METHODS: A randomized controlled trial comparing a 12-week multidisciplinary team care program (1 day per week; individual treatments, group-exercises and group-education) with outpatient clinic care. Outcome measures included the HAMIS (Hand Mobility in SSc), grip-strength, maximal mouth-opening (MMO), 6-minute-walk-distance (6MWD), maximum aerobic-capacity (VO2(max) ), CIS-20 (Checklist Individual Strength), SSc-HAQ (Health Assessment Questionnaire) and SF-36 (0, 12 and 24 weeks). Statistical comparisons of change scores were done by analysis of covariance. RESULTS: Twenty-eight patients were assigned to the intervention group (mean age 54.6 years, 15/28 diffuse SSc) and 25 to the control group (mean age 52.2 years, 15/25 diffuse SSc). Twenty-five (89%) patients in the intervention group completed the treatment program. At 12 weeks there was a significantly greater improvement in grip-strength (2.2 versus -1.8 kg; p=0.001), MMO (1.4 versus -0.9 mm; p=0.000), 6MWD (42.8 versus 3.9 meter; p=0.015) and HAQ (-0.18 versus 0.13; p=0.003) in the intervention group, whereas differences for the other outcome measures didn't reach significance. At 24 weeks the effect on MMO persisted. CONCLUSION: In patients with SSc a 12-week multidisciplinary day patient treatment program was more effective than regular outpatient care with respect to 6MWD, grip-strength, MMO and HAQ, but not for VO2(max) , HAMIS, CIS-20, SF-36 and VAS pain. This study provides a first step in quantifying the effect of a multidisciplinary team care program and warrants the conduct of further intervention studies. Show less
Fransen, J.; Visser, K.; Dongen, H. van; Huizinga, T.; Riel, P.L.C.M. van; Heijde, D.M. van der 2010
Objective. To study whether the Disease Activity Score (DAS) is a valid measure of disease activity in undifferentiated arthritis (UA). Methods. Data from a randomized, double-blind, placebo... Show moreObjective. To study whether the Disease Activity Score (DAS) is a valid measure of disease activity in undifferentiated arthritis (UA). Methods. Data from a randomized, double-blind, placebo-controlled trial of methotrexate (MTX) and placebo involving 110 patients with UA were used. Data included baseline and 3, 6, 9, and 12 months, as well as diagnosis at 18 months. Validity of the DAS was analyzed using factor analysis, correlations with disease activity variables, correlations with changes in disability and joint damage, differences in DAS between diagnoses, and detecting the difference between placebo and MTX. Results. Three disease activity factors were retrieved from the disease activity variables: patient reported outcomes, tender and swollen joints, and acute phase reactants. The DAS had its highest correlations (r > 0.77) with tender joint counts, followed by swollen joint counts (r > 0.63) and patient reported outcomes (r > 0.30), but the DAS correlated less with C-reactive protein levels (r = 0.32). Over time, the DAS was related to the Health Assessment Questionnaire response with an odds ratio of 4.1 (95% confidence interval 2.1-8.0), but not with change in joint damage. At 18 months, the mean DAS was 2.6 for rheumatoid arthritis patients, 2.2 for UA patients, and 1.9 for patients in remission (P = 0.001). The DAS discriminated better than all single variables between MTX and placebo, with a Guyatt's effect size of 0.89. Conclusion. The DAS appears to be a reasonably valid measure of disease activity for use in UA clinical trials. Show less
Deodhar, A.; Braun, J.; Inman, R.D.; Mack, M.; Parasuraman, S.; Buchanan, J.; ... ; Heijde, D. van der 2010
Objective. To evaluate the effect of golimumab on sleep disturbance in patients with active ankylosing spondylitis (AS). Methods. Golimumab was studied in a multicenter, randomized, placebo... Show moreObjective. To evaluate the effect of golimumab on sleep disturbance in patients with active ankylosing spondylitis (AS). Methods. Golimumab was studied in a multicenter, randomized, placebo-controlled study (GO-RAISE). At baseline, 356 patients were randomly assigned in a 1.8:1.8:1 ratio to subcutaneous golimumab 50 mg, 100 mg, or placebo every 4 weeks. Sleep disturbance was assessed using the Jenkins Sleep Evaluation Questionnaire (JSEQ), which was administered at baseline, week 14, and week 24. Treatment effect was evaluated using analysis of variance on the van der Waerden normal scores. Results. Median JSEQ scores at baseline were 9.0 in the placebo group, 10.0 in the 50-mg group, and 11.0 in the 100-mg group, indicating moderate to severe sleep disturbance. Patients who received golimumab showed significantly greater median improvement from baseline in JSEQ scores compared with placebo at week 14 (-3.0 versus 0.0; P < 0.001) and week 24 (-3.0 versus -1.0; P < 0.001). Changes from baseline in JSEQ scores significantly correlated with changes from baseline in Short Form 36 summary scores, Bath AS Functional Index scores, total back pain, night back pain, and Bath AS Disease Activity Index scores. Multiple regression analyses indicated that improvement in the night back pain score was the most consistent predictor of change in JSEQ score or reduction in sleep disturbance. Conclusion. Patients with active AS showed significant sleep disturbance at baseline due to underlying pain associated with AS. Treatment with subcutaneous golimumab every 4 weeks significantly reduced sleep disturbance and improved health-related quality of life. Show less
Objective. The patient acceptable symptom state (PASS) is a single-question outcome tool to assess the level of symptoms at which patients with rheumatic diseases consider themselves well. We... Show moreObjective. The patient acceptable symptom state (PASS) is a single-question outcome tool to assess the level of symptoms at which patients with rheumatic diseases consider themselves well. We evaluated whether ankylosing spondylitis (AS) patient characteristics were associated with attaining the PASS and whether these characteristics influenced PASS thresholds for patient-reported outcome (PRO) tools. Methods. The Adalimumab Trial Evaluating Long-term Efficacy and Safety for Ankylosing Spondylitis was a randomized, placebo-controlled study that evaluated the efficacy and safety of adalimumab in treating AS. The PASS and PROs were assessed over 24 weeks. PASS thresholds for PROs were set as either the 25th or 75th percentiles of the PRO response score. Logistic regression analyses were conducted to determine the associations of particular patient characteristics with the PASS and other response outcomes at 12 weeks (ASessment in Ankylosing Spondylitis International Working Group criteria for 20% improvement [ASAS20], ASAS40, ASAS5/6, ASAS partial remission, and Bath Ankylosing Spondylitis Disease Activity Index 50% improvement). Results. Age >40 years, disease duration >10 years, female sex, placebo treatment, and English-speaking site were consistently associated with greater PASS thresholds for PROs. Age, male sex, disease duration, and treatment were each independently associated with attainment of the PASS at 12 weeks. Only age and treatment were independently associated with other response outcomes. PASS thresholds also decreased over 24 weeks. Conclusion. PASS thresholds for PROs changed over time. These thresholds, as well as the attainment of the PASS, were affected by covariates unrelated to treatment. If confirmed in other studies, these results cast doubt on using the PASS to assess absolute health status in clinical research. Show less
Giesen, F.J. van der; Lankveld, W. van; Hopman-Rock, M.; Jong, Z. de; Munneke, M.; Hazes, J.M.W.; ... ; Vlieland, T.P.M.V. 2010
Objective. To evaluate the implementation of an intensive group exercise program in patients with rheumatoid arthritis (RA). Methods. In 4 regions in The Netherlands, the Rheumatoid Arthritis... Show moreObjective. To evaluate the implementation of an intensive group exercise program in patients with rheumatoid arthritis (RA). Methods. In 4 regions in The Netherlands, the Rheumatoid Arthritis Patients In Training exercise program was implemented on a limited scale. Evaluation using the RE-AIM model included: Reach, the proportion of the target population participating; Efficacy, effects on muscle strength, aerobic capacity, functional ability, and psychological functioning; Adoption, program adoption by stakeholders; Implementation, intervention quality (quality audits); and Maintenance, stakeholders' willingness to continue the program in the future. Results. Twenty-five physical therapists from 14 practices were trained to provide the program. In total, 150 RA patients were recruited (by estimation, 2% of the target population). Of the 81 patients who had finished the 12-month intervention and were available for followup directly after the intervention, 62 patients provided clinical data. Muscle strength improved significantly, whereas aerobic capacity, functional ability, psychological functioning, and disease activity did not change. All 9 informed local patient organizations facilitated patient recruitment, and 35 of 51 rheumatologists involved referred one or more patients. All 10 approached health insurance companies funded the program for 12 months. The quality audits showed sufficient quality in 9 of 12 practices. All of the providers of the program were willing to provide the program in the future, whereas future reimbursement by health insurance companies remained unclear. Conclusion. The implementation of an intensive exercise program for RA patients on a limited scale can be considered successful regarding its reach, adoption, and implementation. The limited effectiveness and the limited data regarding maintenance warrant additional research. Show less
Bridges, S.L.; Causey, Z.L.; Burgos, P.I.; Huynh, B.Q.N.; Hughes, L.B.; Danila, M.I.; ... ; Heijde, D.M. van der 2010
Objective. To describe radiographic changes in African Americans with rheumatoid arthritis (RA) from the Consortium for the Longitudinal Evaluations of African Americans with Early Rheumatoid... Show moreObjective. To describe radiographic changes in African Americans with rheumatoid arthritis (RA) from the Consortium for the Longitudinal Evaluations of African Americans with Early Rheumatoid Arthritis (CLEAR) Registry, a multicenter observational study. Methods. Self-declared African American patients were enrolled in CLEAR I, a longitudinal cohort of early RA (disease duration of <2 years) from 2000 to 2005, or in CLEAR II, a cross-sectional cohort (any disease duration) from 2006 to the present. Demographic and clinical data were obtained, and sets of hand/wrist and foot radiographs were scored using the modified Sharp/van der Heijde scoring system. Results. A total of 357 and 418 patients were enrolled in CLEAR I and CLEAR II, respectively. We report here an interim analysis of radiographic severity in these patients. For the CLEAR I cohort, 294 patients had a mean radiographic score of 2.89 at the baseline visit; 32.0% showed either erosions (25.9%) or joint space narrowing (JSN; 19.4%). At the 36-month visit, the mean score was 5.65; 44.2% had erosions, 41.5% had JSN, and 54.4% had either. Among those patients without radiographic damage at baseline, 18.9% had progressed at the 36-month visit, compared with 57.1% of those with baseline damage (P < 0.0001). For the CLEAR II cohort, of 167 patients with RA of any duration, 65.3% exhibited joint erosions, 65.3% exhibited JSN, and 74.8% exhibited either. The mean radiographic score was 33.42. Conclusion. To our knowledge, this is the largest radiographic study of African American RA patients. Damage occurs early in the disease and is associated with radiographic progression at 3 years of disease duration. The CLEAR Registry will provide a valuable resource for future analyses of genetic, clinical, and environmental factors associated with radiographic severity of RA in African Americans. Show less
