Showing papers in "Arthritis Care and Research in 2011"

Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A)

Abstract: This review covers commonly used measures of anxiety. For this review, the author included measures that were 1) measures of general measures of anxiety and severity of anxiety symptoms, 2) administered by self-report, 3) used in rheumatologic populations, and 4) has evidence of adequate psychometric data. To maintain brevity, the majority of the measures reviewed here were selected to provide broad coverage of general symptoms of anxiety, and measures were excluded if they are intended to identify or characterize a specific Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) anxiety disorder (1). Specifically, this author excluded measures typically used to evaluate diagnostic criteria or features of specific anxiety disorders, such as panic disorder, obsessive-compulsive disorder, posttraumatic stress disorder, and others. In addition, broader measures of psychiatric distress, including the Symptom Checklist-90, the General Health Questionnaire, and the Medical Outcomes Study Short Form 36 are not included in this review since they are included elsewhere in this special issue. However, subscales that have been used frequently in rheumatology as “stand-alone” measures, such as the anxiety scale of the Hospital Anxiety and Depression Scale, are included in this review. Importantly, the measures included in this review should not be interpreted as diagnostically significant for an anxiety disorder, even generalized anxiety disorder, but should be used to measure the presence of symptoms and to calibrate the severity of general symptoms of anxiety commonly occurring in rheumatic disease. The measures reviewed below include the State Trait Anxiety Index, the Beck Anxiety Inventory, and the anxiety subscale of the Hospital Anxiety and Depression Scale. In this review, the content and structure of each measure is presented (number of items, recall period, response options, presence of translations, and adaptations), the use in rheumatic disease when possible is discussed, and the psychometric properties of each measure, particularly when validated in any of the rheumatic diseases, is detailed. In addition, information regarding responsiveness of each measure to longitudinal change is presented, including responsiveness to change in rheumatology when available. Finally, a summary of the strengths and weaknesses specific to rheumatology is presented.

Measures of knee function: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), Lysholm Knee Scoring Scale, Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Activity Rating Scale (ARS), and Tegner Activity Score (TAS)

Abstract: Patient-reported measures of knee function are important for the comprehensive assessment of rheumatology conditions in both clinical and research contexts. To merit inclusion in this review, measures of knee function were required to be patient reported and assess aspects considered important by adult patients with knee problems such as injury or osteoarthritis (OA). Therefore, measures used in rheumatology, orthopedics, and sports medicine were considered. Dimensions deemed to be important to patients included pain, function, quality of life, and activity level. To identify instruments fulfilling these criteria, we utilized published reviews of knee instruments (1), knee OA instruments (2), and measures for use in patellofemoral arthroplasty (3). Based on these reviews, as well as extensive searches of more recent literature, we included the following 9 patient-reported outcomes: Activity Rating Scale, International Knee Documentation Committee Subjective Knee Evaluation Form, Knee Injury and Osteoarthritis Outcome Score, Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form, Knee Outcome Survey Activities of Daily Living Scale, Lysholm Knee Scoring Scale, Tegner Activity Scale, Oxford Knee Score, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Although the WOMAC can be applied to the hip and knee, this study contains data only applicable to the knee. Measures assessing activity level are listed separately. Psychometric data pertaining to the reliability and responsiveness of each patient-reported outcome are shown in Tables 1 and ​and2.2. The number of psychometric reports concerning each instrument ranges from 2–27. A higher number of reports indicates a higher degree of certainty in interpretation of the psychometric properties. Table 1 Summary of reliability data* Table 2 Summary of responsiveness data* Psychometric properties were based on data provided in Tables 1 and 2, and interpreted using standardized guidelines. Internal consistency was considered adequate if Cronbach’s alpha was at least 0.7 (4), and test–retest (intra-rater) reliability was adequate if the intraclass correlation coefficient was at least 0.8 for groups and 0.9 for individuals (5). Floor and ceiling effects were considered to be absent if no participants scored the bottom or top score, respectively, and acceptable if 0.8 were considered large (9). In this context, the minimum clinically important difference is the amount of change of a patient-reported outcome that represents a meaningful change to the patient, while the patient-acceptable symptom state is the least abnormal function score at which patients would consider themselves having acceptable function (10).

Measures of depression and depressive symptoms: Beck Depression Inventory-II (BDI-II), Center for Epidemiologic Studies Depression Scale (CES-D), Geriatric Depression Scale (GDS), Hospital Anxiety and Depression Scale (HADS), and Patient Health Questionnaire-9 (PHQ-9).

Abstract: This article presents a summary of self-report adult measures that are considered to be most relevant for the assessment of depression in the context of rheumatology clinical and/or research practice. This piece represents an update of the special issue article that appeared in Arthritis Care & Research in 2003; the current review followed similar selection criteria for inclusion of assessment tools. Specifically, measures were selected based on several considerations, including ease of administration, interpretation, and adoption by arthritis health professionals from varying backgrounds and training perspectives; self-report measures providing data from the patient or research participant’s perspective; availability of adequate psychometric literature and data involving rheumatology populations; and frequent use in both clinical and research practice with adult rheumatology populations. This study was not intended to be exhaustive. Clinicianadministered, semistructured depression interviews requiring specialized training such as the Hamilton Rating Scale for Depression and Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition were not included. Additionally, measures without sufficient use within rheumatology populations, such as the World Health Organization Composite International Diagnostic Interview depression module and the National Institutes of Health Patient-Reported Outcomes Measurement Information System, were also not included in this review. Self-report measures that have been included in this review are as follows: Beck Depression Inventory-II, Center for Epidemiologic Studies Depression Scale, Geriatric Depression Scale, Hospital Anxiety and Depression Scale, and Patient Health Questionnaire-9. Some of these measures have become integrated into routine clinical practice (as screening tools) in large managed-care organizations, and these specifics have been included in this article. Included within each measure review are “additional references” that, while not cited within the review itself, may be of interest to the arthritis health professional who intends to use this instrument in their clinical practice or as part of a research study. As a general comment regarding any assessment of depression, while care was taken to include measures that require little training to administer and interpret, users without psychological background/experience in the management of clinical issues related to depression and crisis situations may need contingency plans for clinical supervision and/or referral sources. Any individual meeting or close to meeting the diagnostic criteria for depressive disorders needs appropriate management and/or referral, including being provided with referral options for different treatment approaches (pharmacologic and/or psychological). Additionally, suicide risk associated with depression must be taken seriously and promptly addressed. Clinicians should have existing plans to immediately deal with anyone who is an imminent danger to self or others (including mandated reporting). Researchers and clinicians ought to identify behavioral health experts (e.g., psychologists, psychiatrists, social workers) who can assist with appropriately handling these types of crisis situations should they be identified in the context of rheumatology clinical or research environments.

2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis: Initiation and Safety Monitoring of Therapeutic Agents for the Treatment of Arthritis and Systemic Features

Abstract: Guidelines and recommendations developed and/or endorsed by the American College of Rheumatology (ACR) are intended to provide guidance for particular patterns of practice and not to dictate the care of a particular patient The ACR considers adherence to these guidelines and recommendations to be voluntary, with the ultimate determination regarding their application to be made by the physician in light of each patient’s individual circumstances Guidelines and recommendations are intended to promote beneficial or desirable outcomes but cannot guarantee any specific outcome Guidelines and recommendations developed or endorsed by the ACR are subject to periodic revision as warranted by the evolution of medical knowledge, technology, and practice

Hyperuricemia and incident hypertension: a systematic review and meta-analysis.

Abstract: Objective A novel rodent model and a recent randomized trial of hyperuricemic adolescents with hypertension suggest a pathogenetic role of uric acid in hypertension, but it remains unknown whether these findings would be applicable to adult populations where the larger disease burden exists. We conducted a systematic review and meta-analysis to determine if hyperuricemia was associated with incident hypertension, particularly in various demographic subgroups. Methods We searched major electronic databases using medical subject headings and keywords without language restrictions (through April 2010). We included prospective cohort studies with data on incident hypertension related to serum uric acid levels. Data abstraction was conducted in duplicate. We analyzed age, sex, and race subgroups. Results A total of 18 prospective cohort studies representing data from 55,607 participants were included. Hyperuricemia was associated with an increased risk for incident hypertension (adjusted risk ratio [RR] 1.41, 95% confidence interval [95% CI] 1.23–1.58). For a 1 mg/dl increase in uric acid level, the pooled RR for incident hypertension after adjusting for potential confounding was 1.13 (95% CI 1.06–1.20). These effects were significantly larger in younger study populations (P = 0.02) and tended to be larger in women (P = 0.059). Two studies suggested that the effect may also be larger among African American individuals. Furthermore, later publication year and US-based studies were significantly associated with a lower effect estimate (P values <0.02). Conclusion Hyperuricemia is associated with an increased risk for incident hypertension, independent of traditional hypertension risk factors. This risk appears more pronounced in younger individuals and women.

American College of Rheumatology provisional criteria for defining clinical inactive disease in select categories of juvenile idiopathic arthritis

Abstract: Objective To prospectively validate the preliminary criteria for clinical inactive disease (CID) in patients with select categories of juvenile idiopathic arthritis (JIA). Methods We used the process for development of classification and response criteria recommended by the American College of Rheumatology Quality of Care Committee. Patient-visit profiles were extracted from the phase III randomized controlled trial of infliximab in polyarticular-course JIA (i.e., patients considered to resemble those with select categories of JIA) and sent to an international group of expert physician raters. Using the physician ratings as the gold standard, the sensitivity and specificity were calculated using the preliminary criteria. Modifications to the criteria were made, and these were sent to a larger group of pediatric rheumatologists to determine quantitative, face, and content validity. Results Variables weighted heaviest by physicians when making their judgment were the number of joints with active arthritis, erythrocyte sedimentation rate (ESR), physician's global assessment, and duration of morning stiffness. Three modifications were made: the definition of uveitis, the definition of abnormal ESR, and the addition of morning stiffness. These changes did not alter the accuracy of the preliminary set. Conclusion The modified criteria, termed the “criteria for CID in select categories of JIA,” have excellent feasibility and face, content, criterion, and discriminant validity to detect CID in select categories of JIA. The small changes made to the preliminary criteria set did not alter the area under the receiver operating characteristic curve (0.954) or accuracy (91%), but have increased face and content validity.

Measures of physical performance assessments: Self-Paced Walk Test (SPWT), Stair Climb Test (SCT), Six-Minute Walk Test (6MWT), Chair Stand Test (CST), Timed Up & Go (TUG), Sock Test, Lift and Carry Test (LCT), and Car Task.

Abstract: In this review, clinical physical performance measures (PPMs) that relate directly to people with lower extremity osteoarthritis (OA) (1), yet are also relevant for other rheumatic conditions that affect the lower extremity, are evaluated. This information is complementary and an update to some of the measures of adult general performance presented in the special issue of Arthritis Care & Research in 2003 (2). In the current review, PPMs are defined as clinician-observed measures of physical function that assess a task that can be classified as “activities” using the World Health Organization International Classification of Functioning, Disability and Health (ICF) model (3). They do not include measures that are specific tests of body structure, body function, or impairments, e.g., specific measures of strength or balance. Physical function is related to “the ability to move around” (4) and “the ability to perform daily activities” (5) and is assessed directly by an observer while the activity is being performed by an individual, usually by timing, counting, or distance measures. PPMs measure what an individual can do rather than what the individual perceives they can do as in self-reported functional measures (5). The selection of PPMs for this review was based on the following criteria: 1) clinical (field) tests: PPMs were selected if they were readily available, required portable or no equipment, and could be conducted within the clinical setting; 2) relevant to core activities commonly impaired in people with OA: a range of PPMs was selected to reflect the ICF activities most relevant to individuals with lower extremity OA, including walking and moving (ICF d450– 69), changing and maintaining body position (ICF d410– 29), climbing (ICF d4551), and carrying, moving, and handling objects (ICF d430–49); 3) current trends: PPMs that have been included in a performance battery for lower extremity OA were targeted to reflect current trends and recommendations in recent literature (a performance battery is a composite of a number of individual PPMs grouped together); and 4) most commonly cited: PPMs for individuals with OA that were most commonly cited in a literature search were given priority over those less frequently cited. A computerized literature search using Medline, CINAHL, ISI Web of Science, Scopus, and Cochrane was performed. Key terms were mapped to medical subject headings terms: osteoarthritis (hip and knee), task performance and analysis, observation, physical examination, walking or mobility limitations, physical fitness, physical functioning or disability evaluation, and performancebased measures.

Measures of hip function and symptoms: Harris Hip Score (HHS), Hip Disability and Osteoarthritis Outcome Score (HOOS), Oxford Hip Score (OHS), Lequesne Index of Severity for Osteoarthritis of the Hip (LISOH), and American Academy of Orthopedic Surgeons (AAOS) Hip and Knee Questionnaire

Abstract: Outcome measures included in this review are the Harris Hip Score, the Hip Disability and Osteoarthritis Outcome Score, the Oxford Hip Score, the Lequesne Index of Sever- ity for Osteoarthritis of the Hip, and the American Acad- emy of Orthopedic Surgeons Hip and Knee Questionnaire.The outcome measures chosen are the most common ones in the literature concerning hip function and symp- toms. Most of them are patient-reported. The selected mea- sures meet the basic requirements for an outcome mea- surement, although there are shortcomings in a few of them.

Systematic review and meta-analysis: anti-tumor necrosis factor α therapy and cardiovascular events in rheumatoid arthritis.

Abstract: Objective Control of rheumatoid arthritis (RA) may reduce the risk of cardiovascular events. We sought to systematically assess the association between anti–tumor necrosis factor α (anti-TNFα) therapy in RA and cardiovascular event rates. Methods Observational cohorts and randomized controlled trials (RCTs) reporting on cardiovascular events (all events, myocardial infarction [MI], congestive heart failure, and cerebrovascular accident [CVA]) in RA patients treated with anti-TNFα therapy compared to traditional disease-modifying antirheumatic drugs were identified from a search of PubMed (1950 to November 2009), EMBase (1980 to November 2009), and conference abstracts. Relative risks (RRs) or hazard ratios and 95% confidence intervals (95% CIs) were extracted. If the incidence was reported, additional data were extracted to calculate an incidence density ratio and its variance. Results The systematic review and meta-analysis include 16 and 11 publications, respectively. In cohort studies, anti-TNFα therapy was associated with a reduced risk for all cardiovascular events (pooled adjusted RR 0.46; 95% CI 0.28, 0.77), MI (pooled adjusted RR 0.81; 95% CI 0.68, 0.96), and CVA (pooled adjusted RR 0.69; 95% CI 0.53, 0.89). Meta-analysis of RCTs also produced a point estimate indicating lower risk of cardiovascular events, but this was not statistically significant (pooled RR 0.85; 95% CI 0.28, 2.59). Conclusion Anti-TNFα therapy is associated with a reduced risk of all cardiovascular events, MI, and CVA in observational cohorts. There was heterogeneity among cohort studies and possible publication bias. The point estimate of the effect from RCTs is underpowered with wide 95% CIs, and cardiovascular events were secondary outcomes, but RCTs also demonstrated a trend toward decreased risk.

Measures of Adult Pain

Abstract: Our purpose is to provide an overview of available generic and rheumatology population–specific questionnaires suitable for evaluating pain in adult rheumatology populations. The content, ease of use, and measurement properties of the questionnaires are presented and compared in order to assist both clinicians and researchers select the questionnaire that is most appropriate for their purpose. The questionnaires are presented in the following order: generic unidimensional pain questionnaires (Visual Analog Scale and Numeric Rating Scale), generic multidimensional pain questionnaires (Short-form McGill Pain Questionnaire, Chronic Pain Grade Scale, and Short Form36 Bodily Pain Scale), and finally an arthritis-specific pain questionnaire (Measure of Intermittent and Constant Osteoarthritis Pain). Composite measures of arthritis symptoms, including pain and associated disability, specifically the Western Ontario and McMaster Universities Osteoarthritis Index and the Arthritis Impact Measurement Scales, are described in Measures of Knee Function and Measures of Disability, respectively.

A longitudinal study to explain the pain-depression link in older adults with osteoarthritis.

Abstract: Objective To evaluate whether osteoarthritis (OA) pain determines depressed mood, taking into consideration fatigue and disability and controlling for other factors. Methods In a community cohort with hip/knee OA, telephone interviews assessed OA pain and disability (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), fatigue (Multidimensional Fatigue Symptom Inventory), depressed mood (Center for Epidemiologic Studies Depression Scale), and covariates (demographics, self-rated health, comorbidity, pain coping, pain catastrophizing, and social support) at 3 time points over 2 years. Drawing on previous research, a path model was developed to test the interrelationships among the key concepts (pain, depression, fatigue, disability) over time, controlling for covariates. Results The baseline mean age was 75.4 years; 78.5% of the subjects were women, 37.2% were living alone, and 15.5% had ≥3 comorbid conditions. WOMAC scores indicated moderate OA symptoms and disability. From the final model with 529 subjects, adjusting for covariates, we found that current OA pain strongly predicted future fatigue and disability (both short and long term), that fatigue and disability in turn predicted future depressed mood, that depressed mood and fatigue were interrelated such that depressed mood exacerbated fatigue and vice versa, and that fatigue and disability, but not depressed mood, led to worsening of OA pain. Conclusion Controlling for other factors, OA pain determined subsequent depressed mood through its effect on fatigue and disability. These effects led to worsening of pain and disability over time. These results support the need for improved pain management in OA to prevent or attenuate the downstream effects of pain on disability and mood.

Phase II study of tofacitinib (CP-690,550) combined with methotrexate in patients with rheumatoid arthritis and an inadequate response to methotrexate.

Abstract: Objective To compare the efficacy, safety, and tolerability of 4 doses of oral tofacitinib (CP-690,550) with placebo in Japanese patients with active rheumatoid arthritis (RA) receiving stable background methotrexate (MTX) who had an inadequate response to MTX alone. Methods A total of 140 patients were randomized to receive tofacitinib 1, 3, 5, and 10 mg twice a day or placebo in this 12-week, phase II, double-blind study. All patients remained on background MTX. Efficacy and safety were assessed at weeks 1, 2, 4, 8, and 12. The primary efficacy end point was the American College of Rheumatology 20% improvement criteria (ACR20) response rate at week 12. Results ACR20 response rates at week 12 were significant (P < 0.0001) for all tofacitinib treatment groups: 1 mg twice a day, 64.3%; 3 mg twice a day, 77.8%; 5 mg twice a day, 96.3%; and 10 mg twice a day, 80.8% versus placebo, 14.3%. A significant dose-response relationship for the ACR20 was observed (P < 0.0001). Low disease activity was achieved by 72.7% of patients with high baseline disease activity for tofacitinib 10 mg twice a day at week 12 (P < 0.0001). Significant improvements in the ACR50, ACR70, Health Assessment Questionnaire Disability Index, and Disease Activity Score 28-3 (C-reactive protein) were also reported. The most commonly reported adverse events (AEs) were nasopharyngitis (n = 13) and increased alanine aminotransferase (n = 12) and aspartate aminotransferase (n = 9) levels. These AEs were mild or moderate in severity. Serious AEs were reported by 5 patients. No deaths occurred. Conclusion In Japanese patients with active RA with an inadequate response to MTX, tofacitinib in combination with MTX over 12 weeks was efficacious and had a manageable safety profile.

Adult measures of general health and health-related quality of life: Medical Outcomes Study Short Form 36-Item (SF-36) and Short Form 12-Item (SF-12) Health Surveys, Nottingham Health Profile (NHP), Sickness Impact Profile (SIP), Medical Outcomes Study Short Form 6D (SF-6D), Health Utilities Index Mark 3 (HUI3), Quality of Well-Being Scale (QWB), and Assessment of Quality of Life (AQOL)

Abstract: tional well-being that is not specific to any disease. The health measures included in this review were further subdivided into generic health profiles (questionnaires that provide assessment of more than 1 dimension of health status) and health utility measures that provide an overall measure of health status rated between perfect health (1.0) and death (0.0). Relevant measures were identified (using medical subject headings [MeSH]) through a systematic search of medical publications indexed to PubMed database. The following search queries were used: [Quality of life (title) AND Outcomes assessment (MeSH terms) AND Rheumatic diseases (MeSH terms)] and [Quality of life (abstract) AND Outcomes assessment (MeSH terms) AND Rheumatic diseases (MeSH terms)]. In MeSH, “rheumatic diseases” are defined as “disorders of connective tissue, especially the joints and related structures, characterized by inflammation, degeneration, or metabolic derangement,” and in

Measures of adult and juvenile dermatomyositis, polymyositis, and inclusion body myositis.

Abstract: The idiopathic inflammatory myopathies, including adult and juvenile dermatomyositis (DM), polymyositis (PM), and inclusion body myositis (IBM), are rare systemic autoimmune diseases that are characterized by chronic proximal muscle inflammation and weakness. In previous decades, there were few commonly used outcome measures in myositis, and those outcome measures were not validated. Thus, in the past the assessment of outcomes in therapeutic trials was focused on non-standardized measurement of muscle strength and function only. Over the last decade, however, two international collaborative groups, the International Myositis Assessment and Clinical Studies Group (IMACS) and the Paediatric Rheumatology International Trials Organisation (PRINTO), have defined consensus core set measures to assess myositis disease activity and damage in adults and children and have begun to validate and standardize these measures (1;2). IMACS and PRINTO have also developed preliminary definitions of improvement, which can be used as outcomes for therapeutic trials. These response criteria combine the core set activity measures to determine clinically meaningful improvement (3;4). Our section on myositis assessment focuses first on these core set measures of disease activity, quality of life (which is part of the PRINTO core set of activity, but a separate assessment domain for IMACS), and disease damage. To date, most of the validation data available for these core set measures are in patients with juvenile DM, with more limited validation in adult patients with DM or PM. Despite these efforts, there are still important gaps in validation of these core set measures, and no validation studies have yet been performed in patients with IBM, although they are now being used frequently in myositis therapeutic trials. We end the chapter with tools that have been used primarily in research studies and a few therapeutic trials, which have some supporting validation in certain subgroups of patients with myositis. These tools are primarily organ-specific measures, including strength and functional assessments and cutaneous assessment tools. Quantitative muscle testing and the IBM Functional Rating Scale are the most commonly used instruments to assess patients with IBM, and although they have little supporting validation in myositis, quantitative muscle testing has been well validated in other myopathies and has been used frequently as an endpoint in therapeutic trials for IBM. Although the methods for the assessment of myositis patients have been limited in their scope, great strides have been made in the last decade in the development of new partially validated tools (see Table 1) and international multidisciplinary consensus in using these measures that should enhance our understanding of the diverse effects of myositis on many organ systems and the development of new therapies. Table 1 Summary of Measures of Disease Activity in Myositis Physician and Patient/Parent Global Activity General Description Purpose An overall rating of the disease activity related to myositis, defined as potentially reversible pathology or physiology resulting from the underlying disease process (1).

Predicting outcomes of lupus nephritis with tubulointerstitial inflammation and scarring

Abstract: Objective In lupus nephritis, glomerular injury correlates poorly with progression to renal failure. While the tubulointerstitium is also commonly involved, the importance of such involvement is not well defined. Therefore, we developed a simple method to assess the prognostic utility of measuring tubulointerstitial inflammation (TI). Methods Sixty-eight systemic lupus erythematosus patients with lupus nephritis were enrolled. Tubulointerstitial lymphocytic infiltrates were quantitated both by anti-CD45 antibody staining and standard histochemical staining. Followup data were obtained and survival analysis was carried out to determine which histologic features were predictive of subsequent renal failure. Results By CD45 staining, TI was a common pathologic finding, with 72% of biopsies having moderate or severe involvement. The extent of TI correlated with serum creatinine, but not with double-stranded DNA antibodies, serum C3, or glomerular inflammation. TI severity, but not glomerular injury, identified patients at greater risk for renal failure (P = 0.02). A high National Institutes of Health (NIH) chronicity index also identified patients at risk for renal failure. However, when the glomerular and tubulointerstitial subcomponents of the NIH chronicity index were separated in a bivariate model, only tubulointerstitial chronicity provided prognostic information (hazard ratio [HR] 2.2, 95% confidence interval [95% CI] 1.3–3.6; P = 0.002 versus HR 1.0, 95% CI 0.7–1.5; P = 0.97 for glomerular chronicity). Conclusion TI identifies lupus nephritis patients at greatest risk for progression to renal failure. The immunologic mechanisms underlying TI may provide novel targets for therapeutic intervention.

Validation of a new pediatric joint scoring system from the International Hemophilia Prophylaxis Study Group: validity of the hemophilia joint health score.

Abstract: Objective. Repeated hemarthrosis in hemophilia causes arthropathy with pain and dysfunction. The Hemophilia Joint Health Score (HJHS) was developed to be more sensitive for detecting arthropathy than the World Federation of Hemophilia (WFH) physical examination scale, especially for children and those using factor prophylaxis. The HJHS has been shown to be highly reliable. We compared its validity and sensitivity to the WFH scale. Methods. We studied 226 boys with mild, moderate, and severe hemophilia at 5 centers. The HJHS was scored by trained physiotherapists. Study physicians at each site blindly determined individual and total joint scores using a series of visual analog scales. Results. The mean age was 10.8 years. Sixty-eight percent were severe (93% of whom were treated with prophylaxis), 15% were moderate (24% treated with prophylaxis), and 17% were mild (3% treated with prophylaxis). The HJHS correlated moderately with the physician total joint score (rs 0.42, P < 0.0001) and with overall arthropathy impact (rs 0.42, P < 0.0001). The HJHS was 97% more efficient than the WFH at differentiating severe from mild and moderate hemophilia. The HJHS was 74% more efficient than the WFH at differentiating subjects treated with prophylaxis from those treated on demand. We identified items on the HJHS that may be redundant or rarely endorsed and could be removed from future versions. Conclusion. Both the HJHS and WFH showed evidence of strong construct validity. The HJHS is somewhat more sensitive for mild arthropathy; its use should be considered for studies of children receiving prophylaxis.

Measures of symptoms and disease status in ankylosing spondylitis: Ankylosing Spondylitis Disease Activity Score (ASDAS), Ankylosing Spondylitis Quality of Life Scale (ASQoL), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Global Score (BAS-G), Bath Ankylosing Spondylitis Metrology Index (BASMI), Dougados Functional Index (DFI), and Health Assessment Questionnaire for the Spondylarthropathies (HAQ-S)

Abstract: Outcome measurement in spondylarthritis, particularly ankylosing spondylitis (AS) has been a rapidly growing field over the last decade, with enormous progress being made in patient-reported outcomes, clinical assessments, physical measurements and composite scoring of disease state, and response to treatment. Many of these advances arose out of need, when anti–tumor necrosis factor therapies were found to have a role in the treatment of AS patients and therefore required appropriate clinical assessment. The Assessment of SpondyloArthritis international Society (ASAS) was first formed in 1995 as a group of clinicians and methodologists with a shared interest in outcome measurement in AS patients, and has grown to incorporate early diagnosis, classification, development and validation of outcome measures, and evaluation of therapeutic modalities. The instruments reviewed here include those recommended in the ASAS core sets for clinical record keeping (in daily clinical practice) and for clinical research, as over time these have been extensively validated and implemented across different clinical settings. The core sets describe those health-related domains that "should" be measured in AS patients in different settings, and recommend appropriate instruments that can be used for that domain. Additional measures included are the AS Quality of Life scale and the Health Assessment Questionnaire for the Spondylarthropathies, which cover health domains not included in the original core sets but have been shown to be important to AS patients through the World Health Organization International Classification of Functioning, Disability and Health projects (1). Finally, the AS Disease Activity Score has also been presented, as an alternative to the Bath Ankylosing Spondylitis Disease Activity Index, as one of the newest measures constructed to assess disease activity.

Cardiovascular and other comorbidities in patients with psoriatic arthritis: A comparison with patients with psoriasis

Abstract: Objective To determine whether the presence of psoriatic arthritis (PsA) is associated with greater comorbidity, in particular cardiovascular morbidity, compared to psoriasis without arthritis. Methods Six hundred eleven patients with PsA were recruited from the University of Toronto Psoriatic Arthritis Clinic and 449 psoriasis without arthritis patients were recruited from the University of Toronto Psoriasis Cohort. The clinical database was used to identify the prevalence of cardiovascular and other comorbidities in both PsA and psoriasis without arthritis patients. Univariate and multivariate logistic regression analyses were conducted to estimate odds ratios (ORs), comparing the odds of ever having a given comorbid disease in PsA patients with those in psoriasis without arthritis patients. Covariates included age, sex, education, smoking status, severity and duration of psoriasis, medication status, and other comorbidities. Results The prevalence of hypertension, obesity, hyperlipidemia, type 2 diabetes mellitus, and at least 1 cardiovascular event in PsA patients was 37.1%, 30.0%, 20.7%, 12.0%, and 8.2%, respectively. This was significantly higher than in psoriasis without arthritis patients, with unadjusted ORs ranging from 1.54 to 2.59. In the multivariate analyses, hypertension remained significantly elevated (adjusted OR 2.17). PsA was also significantly associated with infections not treated with antibiotics (presumably viral), neurologic conditions, gastrointestinal disorders, and liver disease (adjusted ORs 2.83, 4.76, 21.53, and 7.74, respectively). Infections treated with antibiotics and depression/anxiety were relatively common in PsA, with a prevalence of 30.5% and 20.7%, respectively. However, this was not significantly different from psoriasis without arthritis after multivariate adjustments. Conclusion The results suggest that inflammatory joint disease may play a role in both cardiovascular and noncardiovascular morbidity in PsA.

Measures of functional status and quality of life in rheumatoid arthritis: Health Assessment Questionnaire Disability Index (HAQ), Modified Health Assessment Questionnaire (MHAQ), Multidimensional Health Assessment Questionnaire (MDHAQ), Health Assessment Questionnaire II (HAQ‐II), Improved Health Assessment Questionnaire (Improved HAQ), and Rheumatoid Arthritis Quality of Life (RAQoL)

Abstract: Rheumatoid arthritis (RA) is one of the few diseases where subjective patient and physician measures are the best predictors of treatment response and future health outcomes. Arguably, the most important of these is the American College of Rheumatology core measure of function. Developed in 1978, the original Health Assessment Questionnaire Disability Index (HAQ) remains the gold standard for measuring functional status in RA (1). However, its length at 41 questions and relatively complex scoring can make clinical use difficult. We summarize the HAQ and the most common measures developed from it including the Modified HAQ, Multidimensional HAQ, HAQ-II, and Improved HAQ (2–5). Although it is not a primary measure of function, we also review the Rheumatoid Arthritis Quality of Life scale as it is the lone RA-specific quality of life measure and, whether correct or not, functional measures are often used as a substitute for quality of life in RA (6). We did not include several measures that have less recent published use and may be promising for future studies, including the visual analog scale for function (7) and the Patient-Reported Outcomes Measurement Information System computerized adaptive test for function (8). HEALTH ASSESSMENT QUESTIONNAIRE DISABILITY INDEX (HAQ)

Cardiovascular profile in ankylosing spondylitis: a systematic review and meta-analysis.

Abstract: Objective Rheumatoid arthritis is associated with increased cardiovascular risk. In ankylosing spondylitis (AS), there is a paucity of information concerning this risk. Our objective was to assess the incidence of myocardial infarction (MI) or strokes and the cardiovascular risk profile in AS patients. Methods We performed a systematic literature review using PubMed, EMBase, and the Cochrane Library up to August 2009. Incidence of MI or stroke was calculated by metaproportion. For cardiovascular risk factors, differences between AS patients and controls were expressed by standardized mean differences using inverse of variance method. Results For MI, 8 longitudinal studies were included. In controls (n = 82,745), 1,318 MI cases were observed (4.6%; 95% confidence interval [95% CI] 1.2%, 10.0%). In AS patients (n = 3,279), 224 MI cases were reported (incidence 7.4%; 95% CI 5.2%, 10.0%). The increase in MI cases in AS patients was not significant (risk ratio 1.88; 95% CI 0.83, 4.28). For stroke, 7 longitudinal studies reported 327 strokes in AS patients (n = 31,949), which is an incidence of 2.2% (95% CI 1.3%, 3.4%). In controls (n = 7,372), one study reported 170 strokes (2.3%; 95% CI 2.0%, 2.7%). For cardiovascular risk factors, 15 case–control studies and 9 abstracts were included (n = 1,214 for patients and n = 1,000 for controls). AS patients were characterized by a higher weighted mean intima-media thickness and higher risk of metabolic syndrome. In AS patients, there was a significant decrease in triglycerides, total cholesterol, and high-density lipoprotein (HDL) cholesterol. Conclusion AS patients appear to be at higher risk of MI, which could be due to low HDL cholesterol levels or to systemic inflammation. Management of cardiovascular risk factors and control of systemic inflammation should be taken into account in AS.

Emotional, physical, and sexual abuse in fibromyalgia syndrome: a systematic review with meta-analysis.

Abstract: Objective To systematically assess the potential association of fibromyalgia syndrome (FMS) with emotional, physical, and sexual abuse. Methods The databases EMBase, Google Scholar, Medline, and PsycINFO (through April 2010) and the reference sections of original studies were searched for eligible studies. Eligible studies were cohort or case–control studies that assessed at least one type of emotional, physical, or sexual abuse in childhood or adulthood in patients with FMS and in controls. Two authors independently extracted descriptive, quality, and outcome data from included studies. Methodologic quality was assessed by the Newcastle-Ottawa Quality Assessment Scale. Odds ratios (ORs) and 95% confidence intervals (95% CIs) were pooled across studies by using the random-effects model. Heterogeneity was assessed by I2 statistics. Results The search identified 18 eligible case–control studies with 13,095 subjects. There were significant associations between FMS and self-reported physical abuse in childhood (OR 2.49 [95% CI 1.81–3.42], I2 = 0%; 9 studies) and adulthood (OR 3.07 [95% CI 1.01–9.39], I2 = 79%; 3 studies), and sexual abuse in childhood (OR 1.94 [95% CI 1.36–2.75], I2 = 20%; 10 studies) and adulthood (OR 2.24 [95% CI 1.07–4.70], I2 = 64%; 4 studies). Study quality was mostly poor. Low study quality was associated with higher effect sizes for sexual abuse in childhood, but not with other effect sizes. Conclusion The association of FMS with physical and sexual abuse could be confirmed, but is confounded by study quality.

Population-based estimates of common comorbidities and cardiovascular disease in ankylosing spondylitis.

Abstract: OBJECTIVE:: To study the rate of common comorbidities and cardiovascular disease in ankylosing spondylitis (AS) patients compared with the general population seeking health care. METHODS:: This cohort study included 935 subjects (67% men) age ≥20 years, diagnosed with AS and the adult background population in southern Sweden. During 2004 to 2007 we recorded the occurrence of physicians' diagnostic codes for a select number of comorbidities commonly associated with AS and cardiovascular disease and risk factors. We obtained standardized morbidity-rate ratios (SMRs) by dividing the observed morbidity rate in AS patients by the expected rate based on the corresponding rate of the disease in the general population of the county seeking health care. RESULTS:: The highest SMRs were found for uveitis 34.35 (95% confidence interval [95% CI] 28.55, 40.98) and inflammatory bowel disease 9.28 (95% CI 7.07, 11.97). Also, we found increased SMRs for ischemic heart diseases 2.20 (95% CI 1.77, 2.70), hypertension 1.98 (95% CI 1.72, 2.28), and diabetes mellitus 1.41 (95% CI 1.10, 1.78). Further, the SMRs for psoriasis, osteoporosis, and atrioventricular blocks were also statistically significantly elevated. CONCLUSION:: Inflammatory diseases affecting the eye and the digestive system were the most notable comorbidities in AS patients, but the rate for cardiovascular disease was also high. Comprehensive longitudinal population-based register data is a promising tool to evaluate the excess consultation rate and total burden of rheumatic disease on patient and society. (Less)

Tai chi exercise for treatment of pain and disability in people with persistent low back pain: A randomized controlled trial

Abstract: Objective To determine the effect of tai chi exercise on persistent low back pain. Methods We performed a randomized controlled trial in a general community setting in Sydney, New South Wales, Australia. Participants consisted of 160 volunteers between ages 18 and 70 years with persistent nonspecific low back pain. The tai chi group (n = 80) consisted of 18 40-minute sessions over a 10-week period delivered in a group format by a qualified instructor. The waitlist control group continued with their usual health care. Bothersomeness of back symptoms was the primary outcome. Secondary outcomes included pain intensity and pain-related disability. Data were collected at pre- and postintervention and analyzed by intent-to-treat. Results Tai chi exercise reduced bothersomeness of back symptoms by 1.7 points on a 0–10 scale, reduced pain intensity by 1.3 points on a 0–10 scale, and improved self-report disability by 2.6 points on the 0–24 Roland-Morris Disability Questionnaire scale. The followup rate was >90% for all outcomes. These results were considered a worthwhile treatment effect by researchers and participants. Conclusion This is the first pragmatic randomized controlled trial of tai chi exercise for people with low back pain. It showed that a 10-week tai chi program improved pain and disability outcomes and can be considered a safe and effective intervention for those experiencing long-term low back pain symptoms.

Socioeconomic determinants of disability and depression in patients with rheumatoid arthritis

Abstract: Objective To examine the relationship between functional limitation, socioeconomic inequality, and depression in a diverse cohort of patients with rheumatoid arthritis (RA). Methods The study design was cross-sectional and subjects were from the University of California, San Francisco RA Cohort. Patients were enrolled from 2 rheumatology clinics, an urban county public hospital and a university tertiary care medical center. Age, sex, race/ethnicity, disease activity, functional limitation, and medications were variables collected at clinical visits. The patient's clinic site was used as a proxy for his or her socioeconomic status. The outcome variable was depressive symptom severity measured by the Patient Health Questionnaire 9. Differences in characteristics between depressed and nondepressed patients were calculated using 2-sided t-tests or the Pearson's chi-square test. For the multivariate analysis, repeated measures with generalized estimating equations were used. Results There were statistically significant differences between depressed and nondepressed patients related to race/ethnicity, public versus tertiary care hospital rheumatology clinic, disability, and medications. In the multivariate analysis, increased functional limitation and public clinic site remained significantly associated with increased depression scores. A significant interaction existed between clinic site and disability. Mean depression scores rose more precipitously as functional limitation increased at the public hospital rheumatology clinic. Conclusion There are disparities in both physical and mental health among individuals with low socioeconomic status. The psychological effects of disability vary in patients with RA such that a vulnerable population with functional limitations is at higher risk of developing depressive symptoms.

Prevention of flare recurrences in childhood‐refractory chronic uveitis: An open‐label comparative study of adalimumab versus infliximab

Abstract: Objective To compare the efficacy and safety of adalimumab versus infliximab in an open-label prospective, comparative, multicenter cohort study of childhood noninfectious chronic uveitis. Methods Thirty-three patients (22 females, 11 males, median age 9.17 years) with refractory, vision-threatening, noninfectious active uveitis were enrolled, and received for at least 1 year infliximab (5 mg/kg at weeks 0, 2, and 6, and then every 6–8 weeks) or adalimumab (24 mg/m2 every 2 weeks). The primary outcome was to assess, once remission was achieved, the time of a first relapse. Time to remission, time to steroid discontinuation, and the number of relapses were also considered. Results Sixteen children (12 with juvenile idiopathic arthritis [JIA], 3 with idiopathic uveitis, and 1 with Behcet's disease) were recruited in the adalimumab cohort and 17 children (10 with JIA, 5 with idiopathic uveitis, 1 with early-onset sarcoidosis, and 1 with Behcet's disease) were recruited in the infliximab group. Cox regression analysis did not show statistically significant differences between the two groups with regard to time to achieve remission and time to steroid discontinuation, whereas a higher probability of uveitis remission on adalimumab during the time of treatment was shown (Mantel-Cox χ2 = 6.83, P < 0.001). At 40 months of followup, 9 (60%) of 15 children receiving adalimumab compared to 3 (18.8%) of 16 children receiving infliximab were still in remission on therapy (P < 0.02). Conclusion Even if limited to a relatively small group, our study suggests that over 3 years of treatment, adalimumab is more efficacious than infliximab in maintaining remission of chronic childhood uveitis.

Measures of function in low back pain/disorders: Low Back Pain Rating Scale (LBPRS), Oswestry Disability Index (ODI), Progressive Isoinertial Lifting Evaluation (PILE), Quebec Back Pain Disability Scale (QBPDS), and Roland‐Morris Disability Questionnaire (RDQ)

Abstract: Treatment of patients with chronic low back pain and its evolving disability primarily tries to improve the patients’ levels of activities and participation. Mostly, self-reported questionnaires have been used for clinical as well as research purposes to assess daily functioning (1,2), of which the most commonly used will be discussed below. However, this information may not necessarily reflect the real capacity of a patient’s performance. A recent review showed that the correlation of self-reported disability and physical activity level was at best moderate for patients with chronic low back pain (3). In order to improve objectivity, measures of body function, e.g., spinal mobility and lumbar extensor muscle strength, have been used, although the correlation with the level of disability is very weak (4,5). Furthermore, there are major concerns about reliability and validity (6–8). Besides the self-reported disability measures, many have urged to use more objective and direct measures of low back pain–specific functional capacity (5,9,10). Capacity is defined as the highest probable level of functioning that a person may reach in an activity domain at any given moment in a standardized environment. Although there is still no consensus for the definition of functional capacity evaluation (FCE), in the past decades, several FCE measures have been developed, of which the Isernhagen Work Systems Functional Capacity Evaluation (IWS-FCE) is among the most frequently used (11,12). However, recently published psychometric data have shown that some of the tasks included in the IWS-FCE are not reliable (13,14). Unfortunately, the entire sequence of tasks in, for example, the IWS-FCE, is time consuming and expensive, as is the training of the test observer. Therefore, we have decided not to include these measures in this review. Nevertheless, in order to keep up with, for example, the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations to evaluate several core outcome domains, including physical functioning (9), we wanted to include easy to use performance tasks. Several tasks have been described (8,15–17), but most of them are not low back pain specific, and some, such as the Back Performance Scale, show insufficient factor structure, as in this measure the quality of the performance is also scored (1,18). Therefore, we decided only to include a performance task that assesses lifting, an activity that specifically might be hampered by low back pain. For the selection of the self-reported disability questionnaires and lifting performance tasks, we only selected questionnaires/tests that are low back pain specific and of which all psychometric, including responsiveness, properties have been studied in relevant low back pain populations and published in peer-reviewed journals. Other criteria for selection were: being available in at least English and for performance task measures, easy to administer, inexpensive, and not time consuming when used in clinical practice.