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OBJECTIVES--Self report scores of physical disability and the use of devices or assistance in performing activities are sometimes integrated in one index of physical function, although they are aimed at measuring different dimensions of physical disability. The properties of both parameters were evaluated in two groups of patients with rheumatoid arthritis (RA). METHODS--A group of patients with RA of recent onset was compared with a group with established disease on four parameters of disability: use of devices, use of personal assistance, and scores on a validated Dutch version of the Health Assessment Questionnaire Disability Index, with and without integrating the use of devices or assistance. Correlation coefficients among disability parameters were calculated. In multiple regression analysis the influence of disease duration on the disability parameters was determined after disease activity, psychological wellbeing, and demographical characteristics had been controlled. RESULTS--Functional disability scores were mainly related to inflammatory activity and psychological wellbeing, whereas the uses of devices had a strong relation with disease duration, independent of current disease activity. Integrating these parameters of disability yielded a parameter that was still mainly associated with disease activity. CONCLUSION--Self report scores of functional disability and the use of devices represent distinct dimensions of physical function in RA. Integrating both parameters into one measure of physical disability does not provide an index adequately reflecting both dimensions. The use of both parameters to measure outcome in long term clinical studies is recommended.

Background

Joint replacement is an effective intervention for people with advanced arthritis, although there is an important minority of patients who do not improve post-operatively. There is a need for robust evidence on outcomes after surgery, but there are a number of measures that assess function after joint replacement, many of which lack any clear theoretical basis. The World Health Organisation has introduced the International Classification of Functioning, Disability and Health (ICF), which divides function into three separate domains: Impairment, activity limitations and participation restrictions. The aim of this study is to compare the properties and responsiveness of a selection of commonly used outcome tools that assess function, examine how well they relate to the ICF concepts, and to explore the changes in the measures over time.

Methods/design

Two hundred and sixty three patients listed for lower limb joint replacement at an elective orthopaedic centre have been recruited into this study. Participants attend the hospital for a research appointment prior to surgery and then at 3-months and 1-year after surgery. At each assessment time, function is assessed using a range of measures. Self-report function is assessed using the WOMAC, Aberdeen Impairment, Activity Limitation and Participation Restriction Measure, SF-12 and Measure Yourself Medical Outcome Profile 2. Clinician-administered measures of function include the American Knee Society Score for knee patients and the Harris Hip Score for hip patients. Performance tests include the timed 20-metre walk, timed get up and go, sit-to-stand-to-sit, step tests and single stance balance test. During the performance tests, participants wear an inertial sensor and data from motion analysis are collected. Statistical analysis will include exploring the relationship between measures describing the same ICF concepts, assessing responsiveness, and studying changes in measures over time.

Discussion

There are a range of tools that can be used to assess function before and after joint replacement, with little information about how these various measures compare in their properties and responsiveness. This study aims to provide this data on a selection of commonly used assessments of function, and explore how they relate to the ICF domains.

Background

Functional capacity is an important outcome in rheumatoid arthritis and is generally measured using the Health Assessment Questionnaire disability index (HAQ). Functional limitation incorporates both activity and damage. Because irreversible damage increases over time, the HAQ may be less likely to show improvement in late than in early rheumatoid arthritis.

Objective

To determine the relation between sensitivity to change of the HAQ and duration of rheumatoid arthritis in reports of clinical trials.

Methods

Data were pooled from clinical trials that measured responses of HAQ scores at three or six months. The effect size of the HAQ was calculated and linear regression used to predict the effect size by duration of rheumatoid arthritis at group level. Treatment effect was adjusted for by including the effect sizes of pain scores and of tender joint counts as additional independent variables in separate models. Subgroup analysis employed contemporary regimens (methotrexate, leflunomide, combination therapies, and TNF inhibitors) only.

Results

36 studies with 64 active treatment arms and 7628 patients (disease duration 2.5 months to 12.2 years) were included. The effect sizes of the HAQ decreased by 0.02 for each additional year of mean disease duration using all trials, and by 0.04/year in the subgroup analysis (p⩽0.01 for both analyses, except for pain adjusted models at three months).

Conclusions

In individual trials, less improvement in the HAQ might be expected in late than in early rheumatoid arthritis. Comparison of changes in HAQ among rheumatoid arthritis trials should take into consideration the disease stage of the treated groups.

BACKGROUND—Although many disability questionnaires measure fact very efficiently, they do not allow for consideration of the relevance of that disability to the patient. Data suggest that professionals misinterpret the relevance of disability for the patient and thus, also, the outcome of treatment.
OBJECTIVES—Firstly, to examine agreement on levels of importance for the items on a validated disability scale (Health Assessment Questionnaire (HAQ) and Modified HAQ (MHAQ)), within groups of patients with rheumatoid arthritis, health professionals, and controls. Secondly, to see if functional items important to patients are included in the HAQ, and whether the HAQ items are important to patients.
METHODS—25 patients with RA, 25 rheumatology health professionals, and 25 healthy controls were asked to rate the importance of the HAQ (20 items) and MHAQ (eight domains). Before seeing the HAQ, patients were asked to generate items of function important to them.
RESULTS—Only a slight-fair agreement within each group was found for the level of importance of the HAQ and MHAQ, and also within any combination of the groups (κ values <0.38). Most of the functional items valued by patients were contained on the HAQ (70%), and no HAQ items were consistently rated as unimportant.
CONCLUSION—Patients, professionals, and healthy controls do not agree on the importance of disabilities. These data support the need to assess the personal impact of disability, as well as disability itself. Individual importance of disability weighted by level of disability is proposed as a model for calculating the personal impact of disability. A new tool to assess the personal impact of disability is being developed.



Background

We have previously proposed a theoretical model for studying physical disability and other outcomes in rheumatoid arthritis (RA). The purpose of this paper is to test a model of impairment and functional limitation in (RA), using empirical data from a sample of RA patients. We based the model on the disablement process framework.

Methods

We posited two distinct types of impairment in RA: 1) Joint inflammation, measured by the tender, painful and swollen joint counts; and 2) Joint deformity, measured by the deformed joint count. We hypothesized direct paths from the two impairments to functional limitation, measured by the shirt-button speed, grip strength and walking velocity. We used structural equation modeling to test the hypothetical relationships, using empirical data from a sample of RA patients recruited from six rheumatology clinics.

Results

The RA sample was comprised of 779 RA patients. In the structural equation model, the joint inflammation impairment displayed a strong significant path toward the measured variables of joint pain, tenderness and swelling (standardized regression coefficients 0.758, 0.872 and 0.512, P ≤ 0.001 for each). The joint deformity impairment likewise displayed significant paths toward the measured upper limb, lower limb, and other deformed joint counts (standardized regression coefficients 0.849, 0.785, 0.308, P ≤ 0.001 for each). Both the joint inflammation and joint deformity impairments displayed strong direct paths toward functional limitation (standardized regression coefficients of -0.576 and -0.564, respectively, P ≤ 0.001 for each), and explained 65% of its variance. Model fit to data was fair to good, as evidenced by a comparative fit index of 0.975, and the root mean square error of approximation = 0.058.

Conclusion

This evidence supports the occurrence of two distinct impairments in RA, joint inflammation and joint deformity, that together, contribute strongly to functional limitations in this disease. These findings may have implications for investigators aiming to measure outcome in RA.

Objectives.

Research shows declining disability rates, but little is known about whether cohort differences are due to delayed onset, increased recovery, or reduced severity of impairment. Furthermore, disease is considered the proximate cause of disability yet chronic conditions rates are increasing, making it unclear whether the conditions predicting specific disability trajectories are changing.

Methods.

We use a latent class analysis of disability trajectories and corresponding mortality with three birth cohorts of the National Long-Term Care Survey to determine how long-term experiences of disablement differ by cohort and chronic conditions.

Results.

More recent cohorts were more likely to experience a decade free of disablement compared with all other disability trajectories. Sensory problems and hypertension correspond to trajectories of non-disablement, whereas hip fracture, stroke, arthritis, and diabetes predict more disabled experiences.

Discussion.

Later life disability is measured nonparametrically to distinguish patterns among long-term trajectories. Findings suggest that more recent cohorts are more likely to forego or delay disability over a decade rather than experience prolonged periods of mild to severe disablement. Serious health events such as stroke, along with diabetes, characterize trajectories of high impairment, warranting future research.

Background

Conservative management of foot problems in patients with rheumatoid arthritis (RA) may consist of the prescription of customised foot orthoses. Indications for foot orthoses are not clear and the effectiveness of the intervention is highly variable among patients. Knowledge on which patients benefit the most from foot orthoses can help to select patients eligible for this type of intervention. The objective of the present study was to determine clinical and demographic factors that predict the outcome of customised foot orthoses on pain and disability in patients with RA.

Methods

A total of 135 RA patients who were supplied with customised foot orthoses were included in this prospective cohort study. Pain and disability were measured before and after the intervention period using a Numeric Rating Scale (NRS) for foot pain, the Foot Function Index (FFI), the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) and a 10-meter walking test. The intervention period consisted of one or more appointments with the podiatrist during which the foot orthoses were customised.

Swollen foot joint count, foot deformity scores, forefoot peak pressure, disease duration, age, gender, body mass index and baseline values of the outcome measures were selected as potential factors predicting outcome. Multivariate linear regression analyses were performed to determine factors associated with change in pain and disability (at P < 0.05).

Results

Disease duration was negatively associated with the change scores in NRS foot pain (P = 0.018), WOMAC pain (P = 0.001), FFI disability (P = 0.003) and WOMAC physical function (P = 0.002). Age was negatively associated with the change score in 10 meter walking time (P = 0.008). For all outcome measures baseline values were positively associated with the change scores (P < 0.001).

Conclusions

Shorter disease duration predicted greater improvements in self-reported foot pain and disability, and younger age predicted greater improvements in walking time after intervention with foot orthoses. Also, higher baseline values of pain and disability predicted greater improvements. Referral for conservative management with foot orthoses in the early stage of RA seems important when aiming to achieve reduction in pain and improvement in daily activities.

Background: Measurement of disability in rheumatoid arthritis is often used to support treatment decisions and outcome assessments, but is used without reference to the impact of disability on individual patients.

Objective: To develop and validate a scale to measure individual values for functions, which is used to weight the level of an individual patient's functional loss and thus calculate the personal impact of disability.

Methods: In four linked studies, first the phraseology for values was explored to develop a stem question for the value scale couched in terms patients understand (face validity). Then short and long versions of the value scale were compared (content validity) and tests of internal consistency and short term reliability undertaken (criterion validity). Finally, the value scale was examined for long term reliability and agreement with expected variables (criterion and construct validity), after which personal impact scores were calculated and their construct validity examined.

Results: Patients understand the concept of values, and a positively phrased stem question was developed for the value scale, for which a short version was reasonably equivalent to a long version. The value scale was reliable over one week (96% changed by <1 point) with positive interitem correlation. Reasonable six and 12 month reliability was shown (52% changed by <0.5 points), and the value scale was independent of disability and clinical, psychological, personality, and social support variables. Personal impact scores were then calculated by using the value scores to weight disability scores. Impact scores varied widely between patients of similar disability. Personal impact for disability showed convergent validity with dissatisfaction with disability, perceived increase in disability, increased disease activity, worse psychological status, low social support, and time trade off for disability. It discriminated between patients with low and high dissatisfaction with disability, life satisfaction, depression, pain, and helplessness.

Conclusion: This individualised personal impact scale should lend meaning to disability scores, improving the interpretation of clinical and research data.

OBJECTIVES:

To investigate the association of body cell mass loss with disease activity and disability in rheumatoid arthritis patients.

INTRODUCTION:

Rheumatoid cachexia, defined as the loss of body cell mass, is important but under-recognized and contributes to morbidity and mortality in patients with rheumatoid arthritis.

METHODS:

One hundred forty-nine rheumatoid arthritis patients and 53 healthy, non-rheumatoid arthritis control subjects underwent anthropometric measurements of body mass index and waist and hip circumferences. Bioelectrical impedance analysis was used to determine the subjects' body compositions, including fat mass, skeletal lean mass, and body cell mass. The disease activity of rheumatoid arthritis was assessed using C-reactive protein serum, the erythrocyte sedimentation rate and the 28-joint disease activity score, while disability was evaluated using a health assessment questionnaire.

RESULTS:

Rheumatoid arthritis patients had lower waist-to-hip ratio (0.86±0.07 vs. 0.95±0.06; p<0.001) and lower skeletal lean mass indexes (14.44±1.52 vs. 15.18±1.35; p = 0.002) than those in the healthy control group. Compared with rheumatoid arthritis patients with higher body cell masses, those with body cell masses lower than median had higher erythrocyte sedimentation rates (40.10±27.33 vs. 25.09±14.85; p<0.001), higher disease activity scores (5.36±3.79 vs. 4.23±1.21; p = 0.022) and greater disability as measured by health assessment questionnaire scores (1.26±0.79 vs. 0.87±0.79; p = 0.004).

CONCLUSIONS:

The loss of body cell mass is associated with higher disease activity and greater disability in rheumatoid arthritis patients. Body composition determined by bioelectrical impedance analysis can provide valuable information for a rheumatologist to more rapidly recognize rheumatoid cachexia in rheumatoid arthritis patients.

We studied rheumatoid arthritis (RA) patients with foot complaints to address the associations between clinical signs and symptoms, radiographic changes, and function in connection with disease duration. Secondly, we describe the contribution of several foot segments to the clinical presentation and function. In 30 RA patients with complaints of their feet, attributed to either signs of arthritis and/or radiographic damage, we compared radiographic, ultrasound, clinical, and functional parameters of the feet and ankle. Pain and swelling of the ankle were correlated weakly but statistically significantly with limitation and disability (0.273 to 0.293) as measured on the 5-Foot Function Index (FFI). The clinical signs of the forefoot joints did not influence any of the functional outcome measures. Radiographic scores for both forefeet (SvdH) and hindfeet (Larsen) were correlated with the total Health Assessment Questionnaire Disability Index (HAQ DI) and the 5-FFI limitation subscale. Pain and disease duration, more than radiographic damage, influence the total HAQ DI significantly. With the progression of time, structural damage and function of the rheumatic foot worsen in RA patients. Pain and swelling of the ankle contribute more to disability than radiographic damage of the foot and ankle.

Today, patients' functioning is a central issue in medicine. Concepts, classifications, and measurements of functioning and health, such as the International Classification of Functioning, Disability and Health (ICF) are of prime importance in clinical practice, teaching, and research. This report compares the contents of three of the most widely used health status measures in rheumatoid arthritis (RA), namely the Health Assessment Questionnaire disability index (HAQ), the Arthritis Impact Measurement Scales 2 (AIMS2), and the Short Form health survey (SF-36) based on the ICF. In addition, their content is compared to the Comprehensive ICF Core Set for RA.

The comparisons illustrate that the different health status measures cover different components, and that they cover the different components with different level of precision. Using the ICF as a reference framework allows a researcher or a recommending instance to see which domains are covered in a specific instrument and, therefore, whether it is necessary to complement the study with other measures. Nevertheless, which specific health status measures to recommend still remains a challenge. If enough care is taken to define "what should be measured", it could form the basis for a solid and stable recommendation, adhered to for many years.

Outcome measures play an extremely important role in clinical trials and observational research. Outcome measures for rheumatoid arthritis cover a whole array of domains, ranging from measures describing the inflammatory process to measures describing the ultimate consequences of long-term disease, such as joint damage, physical function and quality of life. There is a scientific need to be able to quantify what is called the 'severity of rheumatoid arthritis', so that patients with rheumatoid arthritis can be clustered according to their propensity to develop an unfavourable outcome. It is a challenge to find an appropriate measure for severity. One attempt has been the development of the Rheumatoid Arthritis Medical Record-Based Index of Severity. This commentary elaborates on how such a measure of severity should be validated to determine whether it is appropriate for practical use.

The purpose of this prospective, single site cohort quasi-experimental study was to determine the responsiveness of the numerical rating scale (NRS), Roland–Morris disability questionnaire (RMDQ), Oswestry disability index (ODI), pain self-efficacy questionnaire (PSEQ) and the patient-specific functional scale (PSFS) in order to determine which would best measure clinically meaningful change in a chronic low back pain (LBP) population. Several patient-based outcome instruments are currently used to measure treatment effect in the chronic LBP population. However, there is a lack of consensus on what constitutes a “successful” outcome, how an important improvement/deterioration has been defined and which outcome measure(s) best captures the effectiveness of therapeutic interventions for the chronic LBP population. Sixty-three consecutive patients with chronic LBP referred to a back exercise and education class participated in this study; 48 of the 63 patients had complete data. Five questionnaires were administered initially and after the 5-week back class intervention. Also at 5 weeks, patients completed a global impression of change as a reflection of meaningful change in patient status. Score changes in the five different questionnaires were subjected to both distribution- and anchor-based methods: standard error of measurement (SEM) and receiver operating characteristic (ROC) curves to define clinical improvement. From these methods, the minimal clinically important difference (MCID) defined as the smallest difference that patients and clinicians perceive to be worthwhile is presented for each instrument. Based on the SEM, a point score change of 2.4 in the NRS, 5 in the RMDQ, 17 in the ODI, 11 on the PSEQ, and 1.4 on the PSFS corresponded to the MCID. Based on ROC curve analysis, a point score change of 4 points for both the NRS and RMDQ, 8 points for the ODI, 9 points for the PSEQ and 2 points for the PSFS corresponded to the MCID. The ROC analysis demonstrated that both the PSEQ and PSFS are responsive to clinically important change over time. The NRS was found to be least responsive. The exact value of the MCID is not a fixed value and is dependent on the assessment method used to calculate the score change. Based on ROC curve analysis the PSFS and PSEQ were more responsive than the other scales in measuring change in patients with chronic LBP following participation in a back class programme. However, due to the small sample size, the lack of observed worsening of symptoms over time, the single centre and intervention studied these results which need to be interpreted with caution.

OBJECTIVE: To be able to measure disability objectively in rheumatoid arthritis complicated by cervical myelopathy. METHODS: The responses to the Stanford health assessment questionnaire disability index were recorded from 250 consecutive patients (group 1) referred to our unit for spinal surgery. Using principal components analysis the questionnaire was reduced from 20 questions to 10 questions. In the second part of the study, the results of the questionnaire for those patients undergoing surgery from the original group of 250 patients were analysed with respect to outcome. RESULTS: The reduction in the number of questions results in no significant loss of information, reliability (internal consistency Cronbach's alpha = 0.968) or sensitivity. The new scale, the myelopathy disability index, measures only one dimension (Eigen value 6.97) and may be more finely tuned to the measurement of disability in these myelopathic patients. When administered to the 194 patients undergoing cervical spine (group 2) surgery the myelopathy disability index was an accurate predictor of neurological and functional outcome, as well as survival following surgery (P < 0.0001). CONCLUSIONS: The myelopathy disability index provides a much needed objective and reliable means of assessing disability in patients with rheumatoid involvement of the cervical spine and also in predicting outcome following surgical intervention. It also provides information for both the patient and surgeon alike, on what to realistically expect from surgery. Its adoption should facilitate comparisons between different forms of surgical intervention.

Objective

To examine the degree to which 2 commonly used measures of pain and disability, the Arthritis Impact Measurement Scales (AIMS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), relate to objective gait measurements.

Design

Descriptive study of the influence of self reported pain and perceived functional impairment on gait mechanics in osteoarthritic adults.

Setting

University clinical research laboratory.

Participants

Overweight/obese adults with radiographic knee osteoarthritis (OA), as well as pain and disability associated with the disease (N=179).

Interventions

Not applicable.

Main Outcome Measures

The AIMS and WOMAC were administered to determine self-report measures of pain and disability. Speed, stride length, support time, knee angle, and peak vertical ground reactions force were determined from 3-dimensional kinematic and kinetic data collected on subjects walking at self-selected normal and fast speeds. Anthropometric data and radiographic levels of OA were also collected.

Results

Pearson’s correlation analysis showed that the AIMS physical disability score was inversely correlated with speed, stride length, KROM, at both speeds, and with PVF at the fast speed. The WOMAC function score was inversely correlated with speed and stride length at both speeds and with peak vertical force at fast speed. The WOMAC pain score was inversely correlated with speed and PVF at the fast speed. Regression analysis revealed that the AIMS physical disability score and body mass index accounted for the greatest variation in speed at normal speed. Overall, AIMS physical disability and WOMAC function explained a larger proportion of variance in gait mechanics than radiographic measures of OA disease severity.

Conclusions

Taken together, the results suggest that the AIMS physical disability and WOMAC function scores are associated with some important measures of gait impairment.

Self assessment health status questionnaires are increasingly used to measure health status or the effect of treatment in patients with rheumatoid arthritis (RA). Most of these questionnaires measure functional (physical) disabilities. The question arises, however, as to how well self assessment questionnaires reflect the true functional status of patients or whether they only reflect their imaginary functional capacities. How valid is the opinion of patients with RA about their own functional capacity? To answer this question an investigation was performed in 80 patients with RA. Forty Dutch and 40 Belgian patients with RA completed the functional items of the DUTCH-AIMS, the Dutch version of the Arthritis Impact Measurement Scales (AIMS), a self assessment questionnaire specific to arthritis. Their scores on the functional scales were compared with the scores on the same scales completed by two experienced physiotherapists after evaluation of the functional ability of these patients. This was achieved by observing the patients perform the tasks given in the questionnaire. Correlation coefficients between the scores of the patients and the physiotherapists were highly significant for all the scales. No significant differences were found between the patients' and physiotherapists' mean scale scores except for the mobility scale in the Dutch patients. The strength of agreement (Cohen's kappa) of most scale scores of the patients and physiotherapists was substantial. The estimates of the overall functional capacity (the mean of the five scale scores) of the Belgian and Dutch patients show high correlations between the patients and the physiotherapists. It is concluded that patients' opinion about their functional ability is valid in that it is in agreement with their real functional abilities. This study provides further evidence for the validity of the DUTCH-AIMS as a measure of functional disability and health status in Dutch and Belgian patients with RA.

Musculoskeletal disorders often have associated pain, functional impairment and work disability, and, not surprisingly, are the most common reasons for utilizing healthcare resources. Rheumatoid arthritis (RA) and fibromyalgia (FM) are causes of musculoskeletal pain and disability. Research indicates that there is a widespread impact of RA and FM on physical, psychological and social factors in affected individuals, and thus, outcome measures that encompass multiple aspects of quality of life are needed. Generic measures of quality of life identify associations between physical conditions and mental health and highlight the need to address psychological functioning to ultimately improve the individuals’ quality of life.

Objectives. Polymyositis (PM) and dermatomyositis (DM) are characterized by impaired muscle function with a majority of patients developing sustained disability. The aim of this study was to evaluate the patient's individual priorities (patient preference) of disabilities most important to improve in PM/DM using the MacMaster Toronto Arthritis Patient Preference Disability Questionnaire (MACTAR), to correlate the MACTAR to myositis outcomes and to evaluate its test-retest reliability. Methods. Twenty-eight patients with PM/DM performed recommended outcomes as well as the MACTAR, which was performed twice with one week apart. Results. Sexual activity, walking, biking, social activities, and sleep constituted the predominating disabilities. Seventy-two and 33% of the identified disabilities were not covered by items of the Health Assessment Questionnaire and the Myositis Activities Profile. Correlations between the MACTAR and health-related quality of life measures were rs = −0.67–0.73, correlations with measures of activities of daily living and participation in society were rs = 0.51–0.60 with lower correlations for other outcomes. Intraclass correlation (ICC) and weighted Kappa (Kw) coefficients were 0.83 and 0.68, respectively, for test-retest reliability of the MACTAR. Conclusions. The MACTAR interview had promising measurement properties and identified patient preference disabilities in PM/DM that were not covered by recommended outcomes.

When functional scales are to be used as treatment outcome measures, it is essential to know how responsive they are to clinical change. This information is essential not only for clinical decision-making, but also for the determination of sample size in clinical trials. The present study examined the responsiveness of a German version of the Oswestry Disability Index version 2.1 (ODI) after surgical treatment for low back pain. Before spine surgery 63 patients completed a questionnaire booklet containing the ODI, along with a 0–10 pain visual analogue scale (VAS), the Roland Morris disability questionnaire, and Likert scales for disability, medication intake and pain frequency. Six months after surgery, 57 (90%) patients completed the same questionnaire booklet and also answered Likert-scale questions on the global result of surgery, and on improvements in pain and disability. Both the effect size for the ODI change score 6 months after surgery (0.87) and the area under the receiver operating characteristics (ROC) curve for the relative improvement in ODI score in relation to global outcome 6 months after surgery (0.90) indicated that the ODI showed good responsiveness. The ROC method revealed that a minimum reduction of the baseline (pre-surgery) ODI score by 18% (equal to a mean 8-point reduction in this patient group) represented the cut-off for indicating a “good” individual outcome 6 months after surgery (sensitivity 91.4% and specificity 82.4%). The German version of the ODI is a sensitive instrument for detecting clinical change after spinal surgery. Individual improvements after surgery of at least an 18% reduction on baseline values are associated with a good outcome. This figure can be used as a reliable guide for the determination of sample size in future clinical trials of spinal surgery.

Objective

Rheumatoid arthritis (RA) is the most prevalent inflammatory rheumatic disorder. It is a chronic and incurable disease that leads to painful inflammation, often irreversible joint damage, and eventually to functional loss.

Conventional treatment is based on unspecific immunosuppressive agents, e.g. Methotrexate, Azathioprin or Gold. However, the longterm outcomes of these approaches have been poor with frequently ongoing inflammatory disease activity, functional decline, and temporary or permanent work disability. More recently, antagonists of the human cytokine Tumor Necrosis Factor α (TNF-α) have been introduced that are potent suppressors of inflammatory processes. Infliximab is a chimeric antibody against TNF-α. Etanercept is a soluble human TNF-α receptor.

The report assesses the efficacy of TNF-α-antagonists to down-regulate inflammation, improve functional status and prevent joint damage in RA with particular regard to the following indications: Treatment of severe, refractory and ongoing disease activity despite adequate use of conventional antirheumatic agents; and treatment of early RA before conventional treatment failure has been demonstrated.

Methods

A systematic review of the literature is been performed using established electronic databases. The literature search is supplemented by a hand search of journals and publications relevant to RA, reviews of websites of national and international rheumatologic expert societies, as well as contacts to manufacturers. A priori defined inclusion and exclusion criteria are used for literature selection. Analysis and evaluation of included publications are based on standardised criteria sets and checklists of the German Scientific Working Group for Technology Assessment in Health Care.

Results

Health Technology Assessment reports and metaanalyses cannot be identified. A total of 12 clinical trials are analysed, as well as national and international expert recommendations and practice guidelines. Numerous non-systematic reviews are found and analysed for additional sources of information that is not identified through the systematic search. Case reports and safety assessements are considered as well. A total of 137 publications is included.

The primary outcome measures in clinical trials are suppression of inflammatory disease activity and slowing of structural joint damage. Clinical response is usually measured by standardised response criteria that allow a semi-quantitative classification of improvement from baseline by 20%, 50%, or 70%.

In patients with RA refractory to conventional treatment, TNF-α-antagonists are unequivocally superior to Methotrexate with regard to disease activity, functional status and prevention of structural damage. In patients with early RA, TNF-α-antagonists show a more rapid onset of anti-inflammatory effects than Methotrexate. However, differences in clinical response rates and radiologic progression disappear after a few months of treatment and are no longer statistically significant. Serious adverse events are rare in clinical trials and do not occur significantly more often than in the control groups. However, case reports and surveillance registries show an increased risk for serious infectious complications, particularly tuberculosis. Expert panels recommend the use of TNF-α-antagonists in patients with active refractory RA after failure of conventional treatment. Studies that compare Infliximab and Etanercept are lacking.

There are no pharmacoeconomic studies although decision analytic models of TNF-α-antagonists for the treatment of RA exist. Based on the results of the models, a combination therapy with Hydroxychloroquin (HCQ), Sulfaslazin (SASP) and Methotrexate as well as Etanercept/Methotrexate can be considered a cost-effective treatment for Methotrexate-resistant RA.

Conclusions

TNF-α-antagonists are clearly effective in RA patients with no or incomplete response to Methotrexate and superior to continuous use of Methotrexate. It refers to both, reduction of inflammatory disease activity including pain relief and improved functional status, and prevention of structural joint damage. Therefore, TNF-α-antagonism is an important new approach in the treatment of RA. There is still insufficient evidence that early use of TNF-α-antagonists in RA prior to standard agents is beneficial and further studies have to be awaited.

An analytic model suggests that TNF-α-antagonists are, due to their clinical effectiveness in patients with no or incomplete response to Methotrexate, a cost-effective alternative to common therapies chosen in the subpopulations of patients. Nevertheless, it has to be borne in mind that the acquisition costs of TNF-α-antagonists lead to high incremental costs and C/E ratios, which exceed the common frame of assessing the cost-effectiveness of medical methods and technologies. Hence, society's willingness-to-pay is the critical determinant in the question whether TNF-α-antagonists shall be reimbursed or not, or to define criteria for reimbursement. Changes in the quality of life attributable to the use of TNF-α-antagonists in RA have not yet been assessed which might assist the decision making.

With respect of the questions mentioned above and the potential financial effect of a systematic use of TNF-α-antagonists in the treatment of RA, we come to the conclusion that TNF-α-antagonists should not introduced as a standard benefit reimbursed by the statutory health insurers in Germany.

Objective

Independent investigations have shown that socioeconomic status (SES) and learned helplessness (LH) are associated with poor disease outcome in patients with rheumatoid arthritis (RA). Our aim was to investigate the cross-sectional relationship between SES, LH, and disease outcome in patients with recent-onset inflammatory polyarthritis (IP), the broader group of conditions of which RA is the major constituent.

Methods

SES was measured using the Index of Multiple Deprivation 2007 for 553 patients consecutively recruited to the Norfolk Arthritis Register. Patients also completed the Rheumatology Attitudes Index, a measure of LH. SES and LH were investigated as predictors of disease outcome (functional disability [Health Assessment Questionnaire (HAQ)] and disease activity [Disease Activity Score in 28 joints]) in a regression analysis, adjusted for age, sex, and symptom duration. The role of LH in the relationship between SES and disease outcome was then investigated.

Results

Compared to patients of the highest SES, those of the lowest SES had a significantly worse outcome (median difference in HAQ score 0.42; 95% confidence interval [95% CI] 0.08, 0.75). Compared to patients with normal LH, patients with low LH had a significantly better outcome and patients with high LH had a significantly worse outcome (median difference in HAQ score 1.12; 95% CI 0.82, 1.41). There was a significant likelihood that LH mediated the association between SES and disease outcome (P = 0.04).

Conclusion

LH is robustly associated with cross-sectional disease outcome in patients with IP, and appears to mediate the relationship between SES and disease outcome. As LH is potentially modifiable, these findings have potential clinical implications.

The occurrence of anemia in older adults has been associated with adverse outcomes including functional decline, disability, morbidity and mortality. It is not clear to what extent these outcomes are the result of the anemia or concurrent illness. We performed a cross-sectional, observational study to determine whether lower hemoglobin concentrations in older adults are associated with reduced health-related quality of life, functional status, depression, disability, and physical strength, independent of chronic disease. Three sites participated in this research; an academic geriatric practice, a hospital based geriatric out patient unit, and a community-based multi-specialty internal medicine group. Health-related quality of life and functional status were measured using the Short Form-36 Health Survey (SF-36) and the Functional Assessment of Chronic Illness Therapy-Anemia (FACIT-An). Disability and depression were assessed using the Instrumental Activities of Daily Living (IADL) and the Geriatric Depression Scale (GDS) questionnaires, respectively. Handgrip strength was used as a physical performance measure. Anemia was defined as hemoglobin < 13 g/dL for men or < 12 g/dL for women. The mean SF-36 physical health component summary scores were 38.9 (with anemia) and 44.1 (without anemia), (P < 0.001). Anemia was associated with greater fatigue (P < 0.001), lower handgrip strength (P = 0.014), increased number of disabilities (P = 0.005) and more depressive symptoms (P = 0.002). Multivariate regression analysis, adjusted for demographic and clinical characteristics, demonstrated strong associations for reduced hemoglobin, even within the “normal” range, and poorer health-related quality of life across multiple domains. Thus, anemia was independently associated with clinically significant impairments in multiple domains of health-related quality of life, especially in measures of functional limitation. Mildly low hemoglobin levels, even when above the WHO anemia threshold, were associated with significant declines in quality of life among the elderly.

Objectives To determine whether direct access to hospital review initiated by patients with rheumatoid arthritis would result in improved clinical and psychological outcome, reduced overall use of healthcare resources, and greater satisfaction with care than seen in patients receiving regular review initiated by a rheumatologist.

Design Two year randomised controlled trial extended to six years.

Setting Rheumatology outpatient department in teaching hospital.

Participants 209 consecutive patients with rheumatoid arthritis for over two years; 68 (65%) in the direct access group and 52 (50%) in the control group completed the study (P = 0.04).

Main outcome measures Clinical outcome: pain, disease activity, early morning stiffness, inflammatory indices, disability, grip strength, range of movement in joints, and bone erosion. Psychological status: anxiety, depression, helplessness, self efficacy, satisfaction, and confidence in the system. Number of visits to hospital physician and general practitioner for arthritis.

Results Participants were well matched at baseline. After six years there was only one significant difference between the two groups for the 14 clinical outcomes measured (deterioration in range of movement in elbow was less in direct access patients). There were no significant differences between groups for median change in psychological status. Satisfaction and confidence in the system were significantly higher in the direct access group at two, four, and six years: confidence 9.8 v 8.4, 9.4 v 8.0, 8.7 v 6.9; satisfaction 9.3 v 8.3, 9.3 v 7.7, 8.9 v 7.1 (all P < 0.02). Patients in the direct access group had 38% fewer hospital appointments (median 8 v 13, P < 0.0001).

Conclusions Over six years, patients with rheumatoid arthritis who initiated their reviews through direct access were clinically and psychologically at least as well as patients having traditional reviews initiated by a physician. They requested fewer appointments, found direct access more acceptable, and had more than a third fewer medical appointments. This radical responsive management could be tested in other chronic diseases.

Purpose

To investigate whether the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) can serve as a generic instrument for measuring disability across different rheumatic diseases and to propose a scoring method based on item response theory (IRT) modeling to support this goal.

Methods

The HAQ-DI was administered to a cross-sectional sample of patients with confirmed rheumatoid arthritis (n = 619), osteoarthritis (n = 125), or gout (n = 102). The results were analyzed using the generalized partial credit model as an IRT model.

Results

It was found that 4 out of 8 item categories of the HAQ-DI displayed substantial differential item functioning (DIF) over the three diseases. Further, it was shown that this DIF could be modeled using an IRT model with disease-specific item parameters, which produces measures that are comparable for the three diseases.

Conclusion

Although the HAQ-DI partially functioned differently in the three disease groups, the measurement regarding the disability level of the patients can be made comparable using IRT methods.

The prognostic value of clinical and laboratory measures in 72 patients with rheumatoid arthritis (RA), seen initially within 18 months of disease onset, in predicting function outcome after a further two years was assessed. Limitation of wrist extension was associated with a slow disease onset, a high articular index and a high latex titre. A reduction in global functional capacity, as measured by the Stanford Health Assessment Questionnaire, was associated with a high initial articular index and a high latex titre. Neither outcome was associated with the initial level of acute phase reactants nor with patient or physician's initial assessment of disease activity. It is concluded, first, that factors predicting early disability outcome in RA are not identical to those associated with continuing disease activity; and secondly, that patients' and physicians' judgment of disease activity at diagnosis do not carry any prognostic value for functional outcome two years later.