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1.

Objective

It has been found that women with rheumatoid arthritis (RA) have a poorer prognosis than men. However, the impact of age at symptom onset is unclear. We investigated the relationship between these factors and functional disability in patients with recent‐onset inflammatory polyarthritis (IP).

Methods

A total of 3,666 patients (66% women) were registered with the Norfolk Arthritis Register between 1990 and 2008. Functional disability was assessed using the Health Assessment Questionnaire (HAQ), adjusted for age at HAQ completion. Linear random‐effects models were used to examine HAQ score over time, by sex and age at symptom onset (early = age <55 years, late = age 55–74 years, very late = age ≥75 years).

Results

Women had higher HAQ scores over time than men (mean difference 0.29; 95% confidence interval [95% CI] 0.25, 0.34). Men with late‐onset IP had lower baseline HAQ scores than men with early onset (mean difference ?0.14; 95% CI ?0.29, ?0.001). Women had comparable baseline HAQ scores at all ages of onset. Both sexes showed the greatest rate of disability progression in patients with very late onset. Those with early onset had a steady level of disability over time. Adjustment for treatment received, comorbidities, and RA subgroup analysis produced results that were largely similar to the initial analysis.

Conclusion

Female patients have higher HAQ scores than male patients; patients with early symptom onset show the smallest sex difference. Older age at symptom onset is associated with an increasingly steep trajectory of disability progression. The impact of sex on outcome is evident at baseline, whereas the impact of age at symptom onset becomes apparent during long‐term followup.
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2.

Objective

Based on comparisons of short‐term cohort studies or cross‐sectional samples of patients from different calendar times, it has been suggested that present patients with rheumatoid arthritis (RA) have a milder disease course compared with that of patients in past decades. This study was undertaken to investigate whether the course of disease activity and functional disability in patients with RA has become milder over the past several years.

Methods

We used the Nijmegen inception cohort of early RA, which included all patients with newly diagnosed RA who had attended the department of rheumatology at Radboud University Nijmegen Medical Centre since 1985. Patients were assessed for disease activity by the Disease Activity Score in 28 joints (DAS28) every 3 months and for functional disability by the Health Assessment Questionnaire (HAQ) disability index (DI) every 6 months. Within the total cohort, 4 subcohorts were defined, based on the date of inclusion of the patients (1985–1990, 1990–1995, 1995–2000, 2000–2005). To investigate whether the course of disease activity and functional disability (over time) was different between the subcohorts, longitudinal regression analysis (linear mixed models) was used, with the DAS28 and HAQ DI over time as outcome variables, respectively, and subcohort as the independent variable, correcting for baseline demographic and clinical characteristics. The treatment strategy was compared between the subcohorts.

Results

The DAS28 at baseline and over the first 5 years of disease was lower in the more recent subcohorts. The HAQ DI did not show improvement but instead a trend toward worsening functional disability. Using longitudinal regression it was shown that disease activity improved early in the disease course and stabilized thereafter, and that this improvement was greater in patients in the more recent subcohorts and in patients with a higher baseline DAS28. Initially, the HAQ DI also improved but stabilized thereafter, and this initial improvement was less pronounced in patients in the more recent subcohorts and was greater for patients with a higher baseline HAQ DI. The treatment strategy was more aggressive in the more recent subcohorts, as shown by a shorter duration from diagnosis to the start of treatment with prednisone or disease‐modifying antirheumatic drugs (DMARDs), and a greater prevalence of DMARD therapy.

Conclusion

The course of disease activity in RA patients has become milder in more recent years. The reason for this improving trend remains to be elucidated, although the trend coincides with a more aggressive treatment strategy.
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3.

Objective

To examine predictors of progression of disability in rheumatoid arthritis (RA), as measured by the Health Assessment Questionnaire disability index (HAQ), and to determine rates of progression during biologic treatment.

Methods

We followed 18,485 RA patients for up to 11 years (mean 3.7 years) in a longitudinal study of RA outcomes. Patients were characterized as having moderate or severe RA versus less severe RA at study entry. Annualized progression rates were determined in multivariable analyses using generalized estimating equations.

Results

Although all of the demographic and severity characteristics were associated with baseline differences in HAQ score, progression was only associated with age, comorbidity, initial severity, and treatment. HAQ score increased fastest in patients ages >65 years (0.031; 95% confidence interval [95% CI] 0.028, 0.034). HAQ progression was independently associated with the presence of baseline cardiovascular disease, hypertension, diabetes mellitus, and the number of comorbid conditions. Annualized progression rates were greater in patients with mild to inactive RA (0.021; 95% CI 0.019, 0.023) than in moderate to severe RA (0.003; 95% CI 0.001, 0.006). The overall progression rate during biologic treatment was 0.008 (95% CI 0.005, 0.011); for patients with moderate to severe RA, the rate was 0.001 (95% CI ?0.005, 0.003).

Conclusion

Age and comorbidity are important predictors of the rate of loss of functional status, and have a stronger effect on HAQ progression than does biologic treatment. There is little difference in progression rates among biologics. Patients with more severe RA progress less than those with less severe RA, a possible function of regression to the mean.
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4.

Objective

To compare the utility values and quality‐adjusted life years (QALYs) obtained by the Time Trade‐Off instrument (TTO) and the EuroQol‐5D (EQ‐5D) in patients with rheumatoid arthritis (RA); to analyze the association between utility values and Disease Activity Score 28 (DAS28) and Health Assessment Questionnaire (HAQ).

Methods

We conducted a longitudinal, prospective, 1‐year study of RA patients selected randomly from 10 rheumatology clinics. TTO and EQ‐5D were administered at 4 scheduled visits.

Results

The study sample comprised 300 RA patients (82% women, mean age 59 years, mean disease duration 10.3 years). A total of 260 patients completed both the TTO and the EQ‐5D at baseline, and the mean ± SD TTO scores were significantly higher than the EQ‐5D scores (0.81 ± 0.22 versus 0.53 ± 0.35, P < 0.0001). The intraclass correlation coefficient (ICC) for the utility methods was 0.19. Data about changes in both TTO and EQ‐5D scores during the study year were available in 163 patients. These changes tended to be larger in the TTO scores than the EQ‐5D scores (mean ± SD 0.05 ± 0.25 versus ?0.005 ± 0.35, P = 0.054). The ICC for the mean changes in the utility scores was 0.24. Patients obtained a mean ± SD of 0.04 ± 0.20 QALYs based on TTO scores and 0.004 ± 0.27 based on EQ‐5D scores (P = 0.12). At baseline, the EQ‐5D scores were highly correlated with the HAQ (r = ?0.74) and moderately correlated with the DAS28 (r = ?0.47), whereas the TTO correlated poorly with both the HAQ and DAS28. Correlation between the mean change in the EQ‐5D and in the HAQ was moderate (r = ?0.55).

Conclusion

TTO and EQ‐5D do not yield the same utility values. The results suggest that the EQ‐5D is more representative of RA status than the TTO, a valuable conclusion when addressing economic evaluations in RA.
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5.

Objective

To compare health‐related quality of life (QOL) between patients with psoriatic arthritis (PsA) and patients with rheumatoid arthritis (RA), using the Medical Outcomes Study Short Form health survey (SF‐36) and the Health Assessment Questionnaire (HAQ).

Methods

Both the SF‐36 and the HAQ were administered to 107 PsA patients attending the University of Toronto Psoriatic Arthritis Clinic between January 1 and December 31, 1994, and to 43 RA patients attending a University of Toronto–affiliated RA clinic during the same period. Standardized assessments of disease activity and severity were also performed at each clinic visit. Logistic regression analysis was used to compare health‐related QOL between PsA and RA.

Results

Both patient populations experienced lower physical health compared with that of a general population sample. The RA patients demonstrated more active inflammatory disease at the time of assessment than the PsA patients. The PsA patients were younger, and more were men. Logistic regression analyses showed that patients with PsA reported higher levels of vitality than patients with RA, even after adjusting for the observed differences in clinical and demographic characteristics. PsA patients, however, reported more role limitations due to emotional problems and more bodily pain after adjusting for the difference in vitality and other covariates.

Conclusions

Although both patient populations experienced reduced QOL, there were some meaningful differences in how the 2 conditions affect health‐related QOL. Further, it appeared that there may be unique disabilities associated with the psoriasis dimension of PsA.
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6.

Objective

To evaluate the self‐administered Quality of Well‐Being (QWB‐SA) Scale for patients with rheumatic diseases.

Methods

Family medicine patients (n = 562) and rheumatology patients (n = 334) were assessed using the following tools: QWB‐SA, Health Assessment Questionnaire (HAQ), Arthritis Impact Measurement Scales (AIMS), and Rapid Assessment of Disease Activity in Rheumatology (RADAR).

Results

Patients with arthritis had significantly lower QWB‐SA scores and significantly higher HAQ scores than family medicine patients with and without adjustment for covariates. The QWB‐SA was significantly associated with quartiles from the RADAR, AIMS, and HAQ, providing evidence for the validity of the generic measure in patients with arthritis. Discriminant function analysis was used to create an arthritis‐specific scoring system for the QWB‐SA. Analyses demonstrated systematic relationships between the Quality of Well‐Being arthritis composite and the disease‐specific RADAR, AIMS, and HAQ.

Conclusions

Evidence supports the validity of the QWB‐SA for patients with rheumatic diseases. QWB‐SA items can be used to calculate an arthritis‐specific score. The QWB‐SA can be used to gain generic information for cost‐utility analysis and disease‐specific outcomes information for patients with arthritis.
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7.

Objective

To evaluate the evolution of functional and clinical outcomes over 11 years in patients with early rheumatoid arthritis (RA) initially treated with a combination of 3 disease‐modifying antirheumatic drugs (DMARDs) or with a single DMARD.

Methods

A cohort of 199 patients with early active RA were initially randomized to receive treatment with a combination of methotrexate, sulfasalazine, and hydroxychloroquine with prednisolone or treatment with a single DMARD (initially, sulfasalazine) with or without prednisolone. After 2 years, the drug treatment strategy became unrestricted, but still targeted remission. At 11 years, function was assessed with the Health Assessment Questionnaire (HAQ), and clinical outcomes were assessed with the modified Minimal Disease Activity (MDA) measure and the American College of Rheumatology (ACR) criteria for remission.

Results

At 11 years, 138 patients were assessed (68 in the combination‐DMARD group and 70 in the single‐DMARD group). The mean ± SD HAQ scores were 0.34 ± 0.54 in the combination‐DMARD group and 0.38 ± 0.58 in the single‐DMARD group (P = 0.88). Modified MDA was achieved by 63% (95% confidence interval [95% CI] 51, 77) and by 43% (95% CI 32, 55) (P = 0.016) of the combination‐DMARD group and the single‐DMARD group, respectively, and ACR remission by 37% (95% CI 26, 49) and by 19% (95% CI 11, 29) (P = 0.017), respectively.

Conclusion

Initial therapy with a combination of DMARDs in early RA results in higher rates of patients achieving modified MDA and strict ACR remission even over the long term than initial single‐DMARD therapy. Targeting remission with tight clinical controls results in good functional and clinical outcomes in most RA patients.
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8.

Objective

To evaluate the impact of a 2‐year home‐based strength‐training program on physical function in patients with early rheumatoid arthritis (RA) after a subsequent 3‐year followup.

Methods

Seventy patients with early RA were randomized to perform either strength training (experimental group [EG]) or range‐of‐motion exercises (control group [CG]). Maximal strength values were recorded by dynamometers. The Modified Disease Activity Score (DAS28), pain, Health Assessment Questionnaire (HAQ), walking speed, and stair‐climbing speed were also measured.

Results

The maximum strength of assessed muscle groups increased by 19–59% in the EG during the training period and remained at the reached level throughout the subsequent 3 years. Muscle strength improved in the CG by 1–31%, but less compared with the EG. During the 2‐year training period, DAS28 decreased by 50% and 45% and pain by 67% and 39% in the EG and CG, respectively. The differences in muscle strength, DAS28, and HAQ were significantly in favor of the EG both at the 2‐year and 5‐year followup assessments.

Conclusions

The improvements achieved during the 2‐year strength‐training period were sustained for 3 years in patients with early RA.
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9.

Objective

The extensively used Health Assessment Questionnaire Disability Index (HAQ‐DI) has been well received by the research and clinical community, notably because of its measurement strengths including reliability and stability of scores over time, utility in observational studies and clinical trials, predictive relationship with morbidity and mortality in rheumatoid arthritis (RA), and its translation for use in different countries. However, HAQ‐DI scoring has not been validated. The purpose of this study was to examine the structural validity of the HAQ‐DI and evaluate the latent factors underlying HAQ‐DI scoring.

Methods

This study used a cross‐validation approach on a total of 278 patients with RA. Exploratory and confirmatory factor analyses were performed.

Results

Results yielded a single‐factor HAQ‐DI score, which favored the current scoring system of the HAQ‐DI. Additionally, modification indices suggested improved model fit with the secondary inclusion of correlated residual scores from a motor skills subdomain.

Conclusion

The current study provides the first validation of the HAQ‐DI scoring system as determined by its latent factor structure. In addition, the findings suggest some benefit from a secondary interpretation of the scores based on domains that measure motor skills.
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10.

Objective

Two simulation models were developed to analyze the cost‐effectiveness of new treatments that affect the progression of rheumatoid arthritis (RA).

Methods

We used data from 2 cohorts of patients with early RA who had been followed up since disease onset (up to 15 years). In the Swedish study, 183 patients were followed up for a mean of 11.3 years. In the UK study, 916 patients were followed up for a mean of 7.8 years. Disease progression over 10 years was modeled as annual transitions between disease states, defined by Health Assessment Questionnaire (HAQ) scores. A regression model was used to estimate transition probabilities conditional on age, sex, and time since onset of disease, in order to allow simulation of different patient cohorts. Costs and utilities associated with different HAQ levels were based on data from the cohort studies and cross‐sectional surveys.

Results

Costs increase and quality of life decreases as RA progresses. In Sweden, total annual costs range from $4,900 to $33,000 per patient, compared with $4,900 to $14,600 in the UK. Cumulative costs over 10 years for patients starting in disease state 1 (HAQ < 0.6) are $54,600 in Sweden and $26,600 in the UK. The cumulative numbers of quality‐adjusted life‐years (QALYs) are 5.5 and 5.6, respectively. Both costs and QALYs were discounted at 3%.

Conclusion

The 2 models, which were based on different patient cohorts, reach a similar conclusion in terms of the effect of RA over 10 years. They appear to accurately capture disease progression and its effects and can therefore be useful in estimating the cost‐effectiveness of new treatments in RA.
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11.

Objective

Although early initiation of disease‐modifying antirheumatic drugs (DMARDs) is effective in controlling short‐term joint damage in individuals with rheumatoid arthritis (RA), the long‐term benefit in disease progression is still controversial. We examined the long‐term benefit of early DMARD initiation on radiographic progression in early RA.

Methods

We identified published and unpublished clinical trials and observational studies from 1966 to September 2004 examining the association between delay to treatment initiation and progressive radiographic joint damage. We included studies of persons with RA disease duration <2 years and DMARD therapy of similar efficacy during followup. The differences in annual rates of radiographic progression between early and delayed therapy were pooled as standardized mean differences (SMDs).

Results

A total of 12 studies met the inclusion criteria. The pooled estimate of effects from these studies demonstrated a significant reduction of radiographic progression in patients treated early (?0.19 SMD, 95% confidence interval [95% CI] ?0.34, ?0.04), which corresponded to a ?33% reduction (95% CI ?50, ?16) in long‐term progression rates compared with patients treated later. Patients with more aggressive disease seemed to benefit most from early DMARD initiation (P = 0.04).

Conclusion

These results support the existence of a critical period to initiate antirheumatic therapy, a therapeutic window of opportunity early in the course of RA associated with sustained benefit in radiographic progression for up to 5 years. Prompt initiation of antirheumatic therapy in persons with RA may alter the long‐term course of the disease.
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12.

Objective

To investigate whether greater social support and support network are cross‐sectionally associated with less functional limitations and psychological distress in patients with early rheumatoid arthritis (RA); whether this association is constant over time; and whether increases in social support or support network are associated with less functional limitations and psychological distress.

Methods

Subjects were from the European Research on Incapacitating Diseases and Social Support cohort and had early RA. Social support, support network, functional limitations (Health Assessment Questionnaire), and psychological distress (General Health Questionnaire) were assessed annually. Variance and covariance analyses with repeated measures were performed.

Results

A total of 542 subjects were assessed for 3 years. On average, patients with a greater amount of specific social support or a stronger specific support network experienced less functional limitation and less psychological distress. Changes in a given subject's functional limitations and psychological distress did not depend on his or her baseline social support or support network. Neither social support nor support network change over time.

Conclusion

There may be a cross‐sectional link between specific social support or support network and functional limitations and psychological distress, but no longitudinal association could be evidenced.
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13.

Objective

To describe the relationship between baseline area‐ and person‐level social inequalities and functional disability at 3 years in patients with early inflammatory polyarthritis (IP).

Methods

A total of 1,393 patients with new‐onset IP were recruited and allocated an Index of Multiple Deprivation (IMD) 2004 score based on their area of residence, and a social class based on baseline self‐reported occupation. Differences in the Health Assessment Questionnaire (HAQ) score at baseline and 3 years by IMD or social class were tested. The mean 3‐year change in HAQ score was compared by IMD and social class, and interactions between these measures examined.

Results

Patients from more deprived areas had poorer 3‐year HAQ outcome than those from less deprived areas (P = 0.019, adjusted for baseline HAQ score, age, sex, and symptom duration). The mean difference in HAQ change was most notable between the most deprived (IMD4) and least deprived areas (IMD1) (0.22; 95% confidence interval [95% CI] 0.11, 0.34). There was also a significant difference in HAQ score change between patients of the highest (SCI and II) and lowest social class (SCIV and V) (0.11; 95% CI 0.02, 0.20). For the mean (95% CI) 3‐year change in HAQ score, a significant interaction exists between IMD score and social class and their association with HAQ scores (P = 0.001) to modify outcome: IMD1/SC I and II ?0.23 (95% CI ?0.40, ?0.06) versus IMD 4/SC IV and V 0.15 (95% CI ?0.05, 0.34).

Conclusion

Person‐ and area‐level inequalities combine to modify outcome for rheumatoid arthritis. A person's social circumstance and residential environment have independent effects on outcome and are not just alternative measures of the same exposure.
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14.

Objective

To identify activity limitation in early rheumatoid arthritis (RA) to detect patients needing assistive devices. To evaluate the effects of assistive devices.

Methods

A multicenter cohort of 284 early RA patients was examined using the Evaluation of Daily Activity Questionnaire 12 and 24 months after diagnosis.

Results

The extent of activity limitation was stable over time for both women and men. Most limitations concerned eating and drinking. Women reported more difficulties than did men. The use of assistive devices was related to subgroups with severe disease and more disability. Use of assistive devices reduced difficulties significantly. For both women and men, assistive devices were mostly used in activities related to eating and drinking.

Conclusion

Already 1 year after diagnosis, RA patients reported activity limitation that remained stable over time. Use of assistive devices was related to more severe disease and more pronounced disability. Use of devices reduced difficulties significantly.
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15.

Objective

To analyze the annual cost of rheumatoid arthritis (RA) and its predictive factors.

Methods

Data were obtained from a 12‐month retrospective cohort of 201 RA patients, randomly selected from a rheumatology registry, through a structured interview and records of the Central Information System of the hospital. Results were divided into direct, indirect, and total costs in 2001 US dollars. A sensitivity analysis was performed. Multiple linear regression models for the different types of costs were carried out.

Results

The total cost was $2.2 million per year, with a cost attributable to RA of $2.07 million per year. The average cost per patient was $10,419 per year (ranging from $7,914 per patient per year in the best scenario to $12,922 per patient per year in the worst case). Direct costs represent nearly 70% of total costs. We found an average increment in total costs of $11,184 per year per unit of Health Assessment Questionnaire (HAQ) score (P < 0.0001) and an average annual increment of $621 per year of disease (P < 0.0001). After adjustment, the HAQ score, inability to perform housework tasks, and being permanently disabled for work were the only predictors of high costs.

Conclusion

Our data show a remarkable economic impact of RA over society and link the costs of the disease to its consequences in terms of functional disability, work disability, and housework disability.
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16.

Objective

To determine how well the American College of Rheumatology (ACR; formerly, the American Rheumatism Association) 1987 classification criteria for rheumatoid arthritis (RA), when used at study inclusion in a cohort of 270 patients with early (<1 year) arthritis, predicted a diagnosis of RA 2 years later and how well they classified these patients at the end of the 2 years.

Methods

Patients were evaluated during 1995–1997 at 7 hospitals in the Brittany region of France. Patients were evaluated at 6‐month intervals until November 1999. The diagnosis made by a panel of 5 rheumatologists (P5R) after the last visit was used as the “gold standard.” The ACR 1987 criteria for RA were applied prospectively, without taking into account the initial diagnosis.

Results

At the last visit (mean ± SD followup 29.1 ± 11.8 months; median 30 months), the P5R diagnosed RA in 98 patients. At the last visit, classification by the ACR criteria was satisfactory, and the combination of an office‐based rheumatologist's (OBR's) diagnosis of RA and fulfillment of the ACR criteria was sensitive (87%; 85 of 98 RA patients had both) and highly specific (99%; 170 of 172 non‐RA patients did not have both). Application of the criteria at the first visit was of limited value for predicting a diagnosis of RA 2 years later.

Conclusion

After a 2‐year followup, the ACR 1987 classification criteria used in combination with an OBR's diagnosis were effective in distinguishing patients with and without RA. The criteria were not useful for predicting RA in patients with arthritis onset within the previous year. Some patients who met the criteria at baseline and after 2 years did not have RA, suggesting that incorporating exclusion criteria may improve the performance of the ACR criteria when used without taking into account the diagnosis by a rheumatologist, particularly in early arthritis.
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17.

Objective

To describe the use of orthopedic surgery, including joint replacement surgery, in a well‐defined, population‐based cohort of patients with rheumatoid arthritis (RA) and to identify characteristics that predict such use.

Methods

A retrospective medical record review was performed of cases of RA incident in Rochester, Minnesota, during the years 1955–1995. All joint surgeries were recorded.

Results

Of the total 609 RA incident cases, 242 patients underwent 1 or more (maximum of 20/patient) surgical procedures involving joints during their followup. Overall, this RA cohort had 7.4 surgeries per 100 person‐years of followup; the cumulative incidence for joint surgery for RA‐related joint disease at 30 years was 33.7% ± SEM 3.8%. The risk of having a disease‐related joint surgery for RA is increased in patients who are women, younger, positive for rheumatoid factor, and have rheumatoid nodules. When adjusted for duration of followup, patients with RA diagnosed after 1985 were significantly less likely to have undergone joint surgery for RA (P < 0.001). Survival of patients who underwent total joint arthroplasty was similar to those who did not.

Conclusion

Reconstructive surgeries are common in RA, although patients diagnosed after 1985 are less likely to require joint surgery. These findings may reflect trends in medical disease management and have importance for health care resource utilization planning.
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18.

Objective

To determine whether arterial wall thickening is advanced in rheumatoid arthritis (RA) patients compared with healthy controls by measuring the intima‐media thickness (IMT) of the common carotid and femoral arteries, and to evaluate the factors associated with arterial IMT in patients with RA.

Methods

We studied 138 RA patients and 94 healthy controls (matched for age, sex, and other major risk factors for atherosclerosis). IMT was measured on digitized still images of the common carotid and femoral arteries obtained by high‐resolution ultrasonography (10‐MHz in‐line Sectascanner). Laboratory variables relevant to RA activity were measured by routine methods. The degree of RA progression was assessed by scoring (Larsen method) metacarpophalangeal (MCP) joints on hand radiographs. Activities of daily living were determined by a modified Health Assessment Questionnaire (M‐HAQ) score, and physical activity levels were assessed by ultrasound measurement of the calcaneus (expressed as the osteo‐sono assessment index [OSI] Z score).

Results

Common carotid and femoral artery IMTs were significantly higher (P < 0.05) in RA patients (mean ± SD 0.641 ± 0.127 and 0.632 ± 0.125 mm, respectively) compared with controls (0.576 ± 0.115 and 0.593 ± 0.141 mm, respectively). Multiple regression analysis revealed a significant association between RA and the common carotid artery IMT. Moreover, the common carotid artery IMT in RA patients was positively associated with disease duration, the MCP joint Larsen score, and the M‐HAQ score, and was negatively associated with the calcaneus OSI Z score. No significant association was found between corticosteroid treatment and common carotid artery IMT.

Conclusion

RA patients exhibited greater thickness of the common carotid and femoral arteries than healthy controls. The duration and severity of RA and decreased activities of daily living, but not corticosteroid treatment, were independently associated with the increased arterial wall thickness.
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19.

Objective

To test the validity and reliability of a newly developed disease‐specific multidimensional quality of life instrument: the Cedars‐Sinai Health‐Related Quality of Life Instrument (CSHQ‐RA).

Methods

A total of 350 rheumatoid arthritis (RA) patients were asked to complete the CSHQ‐RA at 2 time points (4 weeks apart). Patients also completed the Medical Outcomes Study Short Form 36 (SF‐36) and the Stanford Health Assessment Questionnaire (HAQ) Disability Index (DI) at the second time point. Construct validity was tested, using Pearson's correlations, by comparing subscale scores on the CSHQ‐RA to those obtained from the mental component summary (MCS) and physical component summary (PCS) of the SF‐36. HAQ DI scores were used to assess the discriminant validity of the CSHQ‐RA. Intraclass correlation coefficients (ICCs) were used to assess test–retest reliability.

Results

Response rates for the first and second survey were 83% (291) and 93% (276), respectively; 84% of respondents were women, and mean age was 57 years. Mean scores ± SDs on instruments were: HAQ 0.73 ± 0.69; MCS 49 ± 12; and PCS 33 ± 11. Pearson's correlations between the CSHQ‐RA subscale scores and the SF‐36 scores ranged from 0.55 to 0.76 (P < 0.001). Analysis of variance indicate that scores on the CSHQ‐RA discriminated between levels of physical disability as measured by the HAQ (P < 0.001). Test–retest reliability was demonstrated in the instrument's subscale scores (ICC 0.70–0.90).

Conclusion

These results support the construct validity, discriminant validity, and reliability of the CSHQ‐RA as a measure that captures the impact of RA on patients' health‐related quality of life.
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20.

Objective

To estimate the cost utility and cost effectiveness of long‐term, high‐intensity exercise classes compared with usual care in rheumatoid arthritis (RA) patients.

Methods

RA patients (n = 300) were randomly assigned to either exercise classes or UC; followup lasted for 2 years. Outcome measures were quality‐adjusted life years (QALYs) according to the EuroQol (EQ‐5D), Short Form 6D (SF‐6D), and a transformed visual analog scale (VAS) rating personal health; functional ability according to the Health Assessment Questionnaire (HAQ) and McMaster Toronto Arthritis Patient Preference Interview (MACTAR); and societal costs.

Results

QALYs in both randomization groups were similar according to the EQ‐5D and SF‐6D, but were in favor of usual care according to the VAS (annual difference 0.037 QALY; 95% confidence interval [95% CI] 0.002, 0.069). Functional ability was similar according to the HAQ, but in favor of the exercise classes according to the MACTAR (annual difference 2.9 QALY; 95% CI 0.9, 4.9). Annual medical costs of the exercise program were estimated at €780 per participating patient (€1 ≈ $1.05). The increase per patient in total medical costs of physical therapy was estimated at €430 (95% CI €318, 577), and the increase in total societal costs at €602 (95% CI €?490, 1,664). For societal willingness‐to‐pay equal to €50,000 per QALY, usual care had better cost utility than exercise classes, and significantly so according to the VAS.

Conclusion

From a societal perspective and without taking possible preventive health effects into account, long‐term, high‐intensity exercise classes provide insufficient improvement in the valuation of health to justify the additional costs.
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