COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune rheumatic Diseases (COVIAAD): safety, immunogenicity and antibody persistence at 12 months following Moderna Spikevax primary series.

OBJECTIVE: To assess the safety, immunogenicity and cellular responses following the Moderna Spikevax primary series in rheumatic disease. METHODS: We conducted a 12-month, prospective, non-randomised, open-label, comparative trial of adults with either rheumatoid arthritis (RA, n=131) on stable treatment; systemic lupus erythematosus (SLE, n=23) on mycophenolate mofetil (MMF); other rheumatic diseases on prednisone ≥10 mg/day (n=8) or age-matched/sex-matched controls (healthy control, HC, n=58). Adverse events (AEs), humoral immune responses (immunogenicity: IgG positivity for anti-SARS-CoV-2 spike protein and its receptor binding domain, neutralising antibodies (NAbs)), cellular responses (ELISpot) and COVID-19 infection rates were assessed. RESULTS: Frequency of solicited self-reported AEs following vaccination was similar across groups (HC 90%, RA 86%, SLE 90%); among them, musculoskeletal AEs were more frequent in RA (HC 48% vs RA 66% (Δ95% CI CI 3 to 32.6)). Disease activity scores did not increase postvaccination. No vaccine-related serious AEs were reported. Postvaccination immunogenicity was reduced in RA and SLE (RA 90.2%, SLE 86.4%; for both, ΔCIs compared with HC excluded the null). Similarly, NAbs were reduced among patients (RA 82.6%, SLE 81.8%). In RA, age >65 (OR 0.3, 95% CI 0.1 to 0.8) and rituximab treatment (OR 0.003, 95% CI 0.001 to 0.02) were negative predictors of immunogenicity. ELISpot was positive in 16/52 tested RA and 17/26 HC (ΔCI 11.2-53.3). During the study, 11 HC, 19 RA and 3 SLE patients self-reported COVID-infection. CONCLUSION: In COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune Diseases, the Moderna Spikevax primary series was safe. MMF, RA age >65 and rituximab were associated with reduced vaccine-induced protection.

Suboptimal Immunization Coverage among Canadian Rheumatology Patients in Routine Clinical Care.

OBJECTIVE: To assess vaccination coverage and predictors of vaccination among a Canadian population of rheumatology patients in routine clinical care. METHODS: In this cross-sectional study, consecutive adult patients presenting to a tertiary rheumatology clinic at the McGill University Health Center between May and September 2015 were asked to fill a survey on vaccination. Patients self-identified as having rheumatoid arthritis (RA), systemic autoimmune rheumatic diseases (SARD), spondyloarthropathies (SpA), or other diseases (OD). Multivariate logistical regression analyses were performed to evaluate patient and physician factors associated with various vaccinations [for influenza, pneumococcus, and hepatitis B virus (HBV)]. Published Quebec general population influenza and pneumococcal vaccination rates in those aged ≥ 65 years were used as comparative baseline rates. RESULTS: Three hundred fifty-two patients were included in the analysis (RA: 136, SARD: 113, SpA: 47, OD: 56). Vaccination rates were reported as follows: (1) influenza: RA 48.5%, SARD 42.0%, SpA 31.9%, OD 88.9%, Quebec general population 58.5%; (2) pneumococcal: RA 42.0%, SARD 37.8%, SpA 29.7%, OD 33.3%, Quebec general population 53.2%; (3) HBV: RA 33.6%, SARD 55.6%, SpA 73.5%, OD 36.8%; and (4) herpes zoster: RA 5.6%, SARD 28.6%, SpA 25.0%, OD 16.7%. Physician recommendation was the strongest independent predictor of vaccination across all vaccine types (influenza: OR 8.56, 95% CI 2.80-26.2, p < 0.001; pneumococcal: OR 314, 95% CI 73.0-1353, p < 0.001; HBV: OR 12.8, 95% CI 5.27-31.1, p < 0.001). Disease group, disease duration, comorbidities, treatment type, and being followed by a primary care physician were not significantly associated with vaccination. CONCLUSION: There is suboptimal immunization coverage among ambulatory rheumatology patients. An important role for patient and physician education is highlighted in our study, especially because physician recommendation of vaccination was strongly predictive of vaccine uptake.

Canadian Pain Society and Canadian Rheumatology Association recommendations for rational care of persons with fibromyalgia: a summary report.

OBJECTIVE: To summarize the development of evidence-based guidelines for the clinical care of persons with fibromyalgia (FM), taking into account advances in understanding of the pathogenesis of FM, new diagnostic criteria, and new treatment options. METHODS: Recommendations for diagnosis, treatment, and patient followup were drafted according to the classification system of the Oxford Centre for Evidence-Based Medicine, and following review were endorsed by the Canadian Rheumatology Association and the Canadian Pain Society. RESULTS: FM is a polysymptomatic syndrome presenting a spectrum of severity, with a pivotal symptom of body pain. FM is a positive clinical diagnosis, not a diagnosis of exclusion, and not requiring specialist confirmation. There are no confirmatory laboratory tests, although some investigation may be indicated to exclude other conditions. Ideal care is in the primary care setting, incorporating nonpharmacologic and pharmacologic strategies in a multimodal approach with active patient participation. The treatment objective should be reduction of symptoms, but also improved function using a patient-tailored treatment approach that is symptom-based. Self-management strategies combining good lifestyle habits and fostering a strong locus of control are imperative. Medications afford only modest relief, with doses often lower than suggested, and drug combinations used according to clinical judgment. There is a need for continued reassessment of the risk-benefit ratio for any drug treatment. Outcome should be aimed toward functioning within a normal life pattern and any culture of disablement should be discouraged. CONCLUSION: These guidelines should provide the health community with reassurance for the global care of patients with FM with the aim of improving patient outcome by reducing symptoms and maintaining function.

2012 Canadian Guidelines for the diagnosis and management of fibromyalgia syndrome: executive summary.

BACKGROUND: Recent neurophysiological evidence attests to the validity of fibromyalgia (FM), a chronic pain condition that affects >2% of the population. OBJECTIVES: To present the evidence-based guidelines for the diagnosis, management and patient trajectory of individuals with FM. METHODS: A needs assessment following consultation with diverse health care professionals identified questions pertinent to various aspects of FM. A literature search identified the evidence available to address these questions; evidence was graded according to the standards of the Oxford Centre for Evidence-Based Medicine. Drafted recommendations were appraised by an advisory panel to reflect meaningful clinical practice. RESULTS: The present recommendations incorporate the new clinical concepts of FM as a clinical construct without any defining physical abnormality or biological marker, characterized by fluctuating, diffuse body pain and the frequent symptoms of sleep disturbance, fatigue, mood and cognitive changes. In the absence of a defining cause or cure, treatment objectives should be patient-tailored and symptom-based, aimed at reducing global complaints and enhancing function. Healthy lifestyle practices with active patient participation in health care forms the cornerstone of care. Multimodal management may include nonpharmacological and pharmacological strategies, although it must be acknowledged that pharmacological treatments provide only modest benefit. Maintenance of function and retention in the workforce is encouraged. CONCLUSIONS: The new Canadian guidelines for the treatment of FM should provide health professionals with confidence in the complete care of these patients and improve clinical outcomes.

Assessing process of care in rheumatoid arthritis at McGill University hospitals.

OBJECTIVE: In rheumatoid arthritis (RA), quality indicators (QIs) are tools used to measure process of care. This study aimed to assess performance of selected QIs from the 2004 Arthritis Foundation's QI Set at 2 major sites of a university network of teaching hospitals. METHODS: The charts and electronic hospital records of 76 RA patients were audited to determine adherence to QIs. Logistic multivariate regression analyses were performed to investigate potential determinants of nonadherence and propose measures to facilitate better QI compliance, as a potential strategy towards RA care improvement. RESULTS: We identified consistent observance of QIs mandating prescription of disease-modifying antirheumatic drug therapy for all patients, drug adjustment with disease activity, prednisone tapering, and bisphosphonate therapy if indicated for patients on glucocorticoids. However, there was either lack of documentation or true inconsistent adherence to QIs dealing with radiograph performance, functional capacity assessment, and screening for hepatitis and tuberculosis before commencement of methotrexate and biologic agents, respectively. For the specific QIs analyzed, we did not find any definite independent associations with the studied variables. CONCLUSIONS: Our findings indicate that while there is frequent evidence for adherence to certain RA quality care standards at our centers, there is less compliance to others. Strategies to optimize the performance or documentation of those found most lacking, namely, functional capacity and screening for specific drug contraindications, could improve patient care. Radiographic disease monitoring, while lacking, may represent a move toward other more sensitive methods of RA progression detection, such as joint ultrasound. The inclusion of patient- and physician-derived information could help elucidate the reasons underlying nonadherence.

The economic burden of systemic lupus erythematosus.

Systemic lupus erythematosus (SLE) is a systemic autoimmune disease characterised by variable and unpredictable manifestations that can severely affect a person's physical and mental well-being, social life and ability to acquire and maintain gainful employment. Damage to vital organs may ensue as a result of the disease itself or as a consequence of treatment, and patients often consume substantial health-care resources and incur considerable health-care costs. Furthermore, SLE tends to affect women in young and middle adulthood, at a time in their lives when they are usually most actively engaged in the workforce, and can have important consequences with respect to acquiring and maintaining employment and advancing in one's career. A number of studies have attempted to assess the health-care costs (direct costs) associated with SLE, the effects of SLE on employment and the associated costs due to decreases in work productivity (indirect costs). In this article, we review a number of recent studies that have added to our current understanding of the economic burden of SLE.

The 2010 American college of rheumatology fibromyalgia survey diagnostic criteria and symptom severity scale is a valid and reliable tool in a French speaking fibromyalgia cohort.

BACKGROUND: Fibromyalgia (FM) is a pain condition with associated symptoms contributing to distress. The Fibromyalgia Survey Diagnostic Criteria and Severity Scale (FSDC) is a patient-administered questionnaire assessing diagnosis and symptom severity. Locations of body pain measured by the Widespread Pain Index (WPI), and the Symptom Severity scale (SS) measuring fatigue, unrefreshing sleep, cognitive and somatic complaints provide a score (0-31), measuring a composite of polysymptomatic distress. The reliability and validity of the translated French version of the FSDC was evaluated. METHODS: The French FSDC was administered twice to 73 FM patients, and was correlated with measures of symptom status including: Fibromyalgia Impact Questionnaire (FIQ), Health Assessment Questionnaire (HAQ), McGill Pain Questionnaire (MPQ), and a visual analogue scale (VAS) for global severity and pain. Test-retest reliability, internal consistency, and construct validity were evaluated. RESULTS: Test-retest reliability was between .600 and .888 for the 25 single items of the FSDC, and .912 for the total FSDC, with all correlations significant (p < 0.0001). There was good internal consistency measured by Cronbach's alpha (.846 for FSDC assessment 1, and .867 for FSDC assessment 2). Construct validity showed significant correlations between the FSDC and FIQ 0.670, HAQ 0.413, MPQ 0.562, global VAS 0.591, and pain VAS 0.663 (all p<0.001). CONCLUSIONS: The French FSDC is a valid instrument in French FM patients with reliability and construct validity. It is easily completed, simple to score, and has the potential to become the standard for measurement of polysymptomatic distress in FM.

Quality of care in systemic lupus erythematosus: application of quality measures to understand gaps in care.

BACKGROUND: Systemic lupus erythematosus (SLE) affects 1 in 2500 Americans and is associated with significant morbidity and mortality. The recent development of SLE quality measures provides an opportunity to understand gaps in clinical care and to identify modifiable factors associated with variations in quality. OBJECTIVE: To evaluate performance on SLE quality measures as well as differences in quality of care by demographic, socioeconomic, disease, and health system characteristics. DESIGN AND PATIENTS: Cross-sectional analysis of data derived from the Lupus Outcomes Study, a prospective, longitudinal study of 814 individuals. Principal data collection was through annual structured telephone surveys between 2009-2010. Data on 13 SLE quality measures was collected. We used regression models to estimate demographic, socioeconomic, disease, and health system characteristics associated with performance on individual and overall quality measures. OUTCOME MEASURES: Performance on each quality measure and overall performance on all measures for which participants were eligible (pass rate). RESULTS: Participants were eligible for a mean of five measures (range 2-12). Performance varied from 29 % (assessment of cardiovascular risk factors) to 90 % (sun avoidance counseling). The overall pass rate was 65 % (95 % CI 64 %, 65 %). In unadjusted analyses, younger age, minority race/ethnicity, poverty, shorter disease duration, fewer physician visits, and lack of health insurance, were associated with lower pass rates. Receiving care in public sector managed care organizations was associated with higher pass rates. After adjustment, younger age, having fewer physician visits and lacking health insurance remained significantly associated with lower performance; receiving care in public sector managed care organizations remained associated with higher performance. CONCLUSIONS: We identified a number of gaps in clinical care for SLE. Factors associated with the health care system, including presence and type of health insurance, were the primary determinants of performance on quality measures in SLE.

Healthcare costs of inflammatory myopathies.

OBJECTIVE: Little information exists regarding the economic burden related to inflammatory myopathies. Our objective was to estimate health services costs in a large, unselected, population-based sample of patients with inflammatory myopathies. METHODS: We identified subjects with polymyositis and dermatomyositis from administrative healthcare databases (covering all beneficiaries, about 7.5 million) in Quebec province, Canada. Average estimates of health services costs (physician visits, diagnostic tests and procedures, outpatient surgeries and procedures, acute care hospitalizations) for 2003 were calculated by multiplying health service use levels by the appropriate unit prices, determined from government fee schedules and other sources. Multiple linear regression analyses were performed to establish whether specific factors (age, sex, disease duration, region of residence, socioeconomic status, type of myositis, disease severity) were associated with cost. RESULTS: We identified 1102 subjects with inflammatory myopathy from January 1, 1989, to January 1, 2003. About two-thirds were women (68.9%); average age at case ascertainment was 57.4 years (SD 18.4). The average cost of all reimbursed health services, in 2008 Canadian dollars, was $4099 per patient (SD $9639). Costs increased with age, and were highest early in the disease course. Greater disease severity (defined as the need for prior hospitalization for myositis) was also a strong predictor of both physician costs and total costs. CONCLUSION: These results indicate significant economic burden related to inflammatory myopathies, with important demographic predictors. Our estimates suggest that the health services costs in inflammatory myopathies may equal, or exceed, those of other serious diseases, such as rheumatoid arthritis and systemic sclerosis.

Long-term patterns of depression and associations with health and function in a panel study of rheumatoid arthritis.

Long-term patterns of depression, and associations with health and function were examined among 1115 individuals with rheumatoid arthritis, using 18 years of panel data, summarized in 9653 interviews. Depression was defined by scores on the Geriatric Depression Scale (6 or above). Participants were classified, using cluster analysis, into three distinct patterns of depression over repeated assessments: nondepressed (65.8%), intermittent (25.2%), and chronic (9.0%). GEE analyses assessed outcomes over time as a function of patterns of depression; controlling for demographic and clinical factors. Results indicated that patterns of depression had significant adverse effects on health and function over time.

Systematic review of the literature informing the systemic lupus erythematosus indicators project: reproductive health care quality indicators.

OBJECTIVE: Systemic lupus erythematosus (SLE) primarily affects women of reproductive age. Here we summarize the scientific evidence supporting recently developed quality indicators (QIs) pertaining to reproductive health. METHODS: We used a modification of the RAND/UCLA Appropriateness Method to develop QIs for SLE. We performed systematic reviews of the literature pertaining to each proposed indicator. Three indicators focusing on reproductive health were included in the final set. Relevant literature was presented to an expert panel, who rated the validity and feasibility of the indicators. RESULTS: Three QIs were rated as valid and feasible. These indicators specifically address laboratory testing during pregnancy in SLE, the treatment of antiphospholipid antibody syndrome, and counseling for drugs with teratogenic potential. CONCLUSION: We used a rigorous method to develop reproductive health QIs for SLE. In the future, these indicators can be used in the assessment and delivery of care to patients with SLE.

Provision of preventive health care in systemic lupus erythematosus: data from a large observational cohort study.

INTRODUCTION: Cancer and infections are leading causes of mortality in systemic lupus erythematosus (SLE) after diseases of the circulatory system, and therefore preventing these complications is important. In this study, we examined two categories of preventive services in SLE: cancer surveillance (cervical, breast, and colon) and immunizations (influenza and pneumococcal). We compared the receipt of these services in SLE to the general population, and identified subgroups of patients who were less likely to receive these services. METHODS: We compared preventive services reported by insured women with SLE enrolled in the University of California, San Francisco Lupus Outcomes Study (n=685) to two representative samples derived from a statewide health interview survey, a general population sample (n=18,013) and a sample with non-rheumatic chronic conditions (n=4,515). In addition, using data from the cohort in both men and women (n=742), we applied multivariate regression analyses to determine whether characteristics of individuals (for example, sociodemographic and disease factors), health systems (for example, number of visits, involvement of generalists or rheumatologists in care, type of health insurance) or neighborhoods (neighborhood poverty) influenced the receipt of services. RESULTS: The receipt of preventive care in SLE was similar to both comparison samples. For cancer surveillance, 70% of eligible respondents reported receipt of cervical cancer screening and mammography, and 62% reported colon cancer screening. For immunizations, 59% of eligible respondents reported influenza immunization, and 60% reported pneumococcal immunization. In multivariate regression analyses, several factors were associated with a lower likelihood of receiving preventive services, including younger age and lower educational attainment. We did not observe any effects by neighborhood poverty. A higher number of physician visits and involvement of generalist providers in care was associated with a higher likelihood of receiving most services. CONCLUSIONS: Although receipt of cancer screening procedures and immunizations in our cohort was comparable to the general population, we observed significant variability by sociodemographic factors such as age and educational attainment. Further research is needed to identify the physician, patient or health system factors contributing to this observed variation in order to develop effective quality improvement interventions.

Frequent use of the emergency department among persons with systemic lupus erythematosus.

OBJECTIVE: To describe characteristics of systemic lupus erythematosus (SLE) patients who are frequent users of the emergency department and to identify predictors of frequent emergency department use. METHODS: Data for this study were derived from the University of California, San Francisco Lupus Outcomes Study, a large cohort of persons with SLE who undergo annual structured interviews. Participants were categorized into 1 of 3 levels of emergency department utilization: nonusers (no visits in the preceding year), occasional users, (1-2 visits), and frequent users (> or =3 visits). We compared characteristics of the 3 groups and determined predictors of frequent emergency department use (> or =3 visits) using multivariate logistic regression, adjusting for a variety of potential confounding covariates. RESULTS: Of 807 study participants, 499 (62%) had no emergency department visits; 230 (28%) had occasional emergency department visits (1-2 visits); and 78 (10%) had frequent (> or =3 visits) emergency department visits. Frequent users were younger, less likely to be employed, and less likely to have completed college. They also had greater disease activity, worse general health status, and more depressive symptoms. Frequent emergency department users were more likely to have Medicaid as their principal insurance. In multivariate logistic regression, older age predicted a lower likelihood of frequent emergency department visits, whereas greater disease activity and having Medicaid insurance predicted a higher likelihood of frequent emergency department visits. CONCLUSION: In persons with SLE, greater disease activity and Medicaid insurance are associated with more frequent emergency department use.

A retrospective review of rheumatology referral wait times within a health centre in Quebec, Canada.

It is important that inflammatory arthropathies such as rheumatoid arthritis be diagnosed promptly so that treatment can be administered in a timely fashion. However, there is considerable evidence that this process of care is delayed in many people. The aim of the study is to assess wait times between primary care referral and rheumatology assessment for new-onset inflammatory arthropathies. We performed a retrospective review related to new rheumatology consultations (N = 202) between September and November 2008 within the McGill University Health Centre, Montreal, Canada. At this centre, no formal triaging of rheumatology referrals exists. Of the 202 charts reviewed, wait times could be calculated in 164 cases. Only consultations for new-onset conditions were analyzed (N = 161). The results showed that patients with inflammatory arthritis were seen approximately 34.6 days (median 26) post-referral. Wait times for individuals who were ultimately diagnosed with non-urgent conditions (osteoarthritis, fibromyalgia and soft-tissue rheumatism) averaged 41.0 days (median 29). In conclusions, compared to non-urgent cases, individuals with inflammatory arthritis were seen about 1 week sooner. Nevertheless, provisional diagnosis provided on referrals did not appear to expedite wait times for persons with suspected inflammatory arthritis. This suggested that other factors, such as the concern of the patient, may have an influence on referral wait times. Implementation of a rapid access program or triage system may be helpful to further decrease wait times for inflammatory arthropathies.

Health-related quality of life in systemic sclerosis: a systematic review.

OBJECTIVE: A number of studies (all n <200) have assessed health-related quality of life (HRQOL) in patients with systemic sclerosis (SSc), but no systematic review of the effect of SSc on HRQOL has been done. The objective of this study was to systematically review the literature on HRQOL in SSc measured using the Medical Outcomes Trust Short Form 36 (SF-36). METHODS: A comprehensive search was conducted in August 2007 using Medline, CINAHL, and EMBase to identify original research studies reporting SF-36 scores of SSc patients. Selected studies were reviewed and characteristics of the study samples and SF-36 data were extracted. Bayesian meta-analysis and meta-regression were performed to obtain pooled estimates of SF-36 physical component summary (PCS) and mental component summary (MCS) scores for all patients as well as by limited and diffuse disease status. RESULTS: Twelve data sets with a total of 1,127 SSc patients were included in the systematic review. HRQOL was impaired in patients with SSc, with pooled SF-36 PCS scores being more than 1 SD below the general population (38.3; 95% credible interval [95% CI] 35.2, 41.5) and pooled SF-36 MCS scores being approximately 0.5 SDs below the general population (46.6; 95% CI 44.2, 49.1). SF-36 PCS scores were 3.5 points (95% CI -1.0, 8.0) lower in patients with diffuse compared with limited disease. CONCLUSION: This study provides robust evidence of the presence and magnitude of impairment in HRQOL in patients with SSc. Although the impairment appears greater in physical health, mental health impairment is also reported.

Bone health in systemic lupus erythematosus.

Patients with systemic lupus erythematosus (SLE) confront an increased risk of developing osteoporosis and fragility fractures. Traditional risk factors, such as smoking, advanced age, physical inactivity, and low weight, are partly responsible, but a number of lupus-specific risk factors may also play an important role. Chronic, systemic inflammation in patients with SLE has been proposed as a possible mechanism for osteoporosis development. Other potential risk factors include vitamin D deficiency due to sun avoidance, premature gonadal failure, and the chronic use of medications known to increase osteoporosis risk. Increased awareness of this potentially preventable condition is warranted, as early detection and treatment help optimize bone health and improve long-term outcomes in patients with SLE. This article presents recent epidemiologic data related to bone health in SLE and discusses preventative and therapeutic strategies.

Long-term medical costs and resource utilization in systemic lupus erythematosus and lupus nephritis: a five-year analysis of a large medicaid population.

OBJECTIVE: To estimate the long-term direct medical costs and health care utilization for patients with systemic lupus erythematosus (SLE) and a subset of SLE patients with nephritis. METHODS: Patients with newly active SLE were found in the MarketScan Medicaid Database (1999-2005), which includes all inpatient, outpatient, emergency department, and pharmaceutical claims for more than 10 million Medicaid beneficiaries. The date a patient became newly active was defined as the earliest observed SLE diagnosis code, with a 6-month clean period prior to the diagnosis. This method identified 2,298 patients with a consecutive followup of 5 years. A reference group of patients without SLE was constructed using propensity score matching. Nephritis was assessed based on diagnosis and procedure codes involving the kidney. RESULTS: Mean annual medical costs for SLE patients totaled $16,089 at year 1, which is significantly greater (by $6,831) than that for reference patients. Costs decreased slightly at year 2 but then increased yearly at an average rate of 16% through year 5, to $23,860. SLE patients without nephritis (n = 1,809) had costs $967-3,756 higher than the reference patients. SLE patients with nephritis (n = 489) had costs $13,228-34,907 greater than the reference group. Inpatient visits for the nephritis subgroup were 0.6-1.0 per capita, which are approximately twice the rate for all SLE patients and 3 to 4 times higher than the reference group. CONCLUSION: SLE is a costly condition to treat. Medical expenses incurred by SLE patients increase steadily over time, particularly for patients with nephritis.

Clinical correlates of self-reported physical health status in systemic sclerosis.

OBJECTIVE: Systemic sclerosis (SSc) is a multisystem disease associated with impaired health-related quality of life (HRQOL). Our objective was to identify the clinical characteristics that correlate with the physical health status of patients with SSc, as assessed by the Medical Outcomes Trust Short Form-36 (SF-36). METHODS: Cross-sectional, multicenter study of 416 patients from the Canadian Scleroderma Research Group Registry. Patients were assessed with detailed clinical histories, medical examinations, and self-administered SF-36. Multiple linear regression was used to assess the relationship between selected demographic and clinical variables and the SF-36 Physical Component Summary (PCS) score. RESULTS: The greatest impairments in the SF-36 were in the domains measuring physical health, and the mean SF-36 PCS score was 37.5 (+/-11.2). In multivariate analysis, significant clinical predictors of the SF-36 PCS were shortness of breath, number of gastrointestinal problems, skin score, swollen joint count, and age. The final model explained 47% of the variance in the SF-36 PCS. CONCLUSION: Clinical characteristics identified as significant correlates of the self-reported physical health status in SSc should each be targets of intervention in order to improve the HRQOL of patients with this disease.

The relationship between renal activity and quality of life in systemic lupus erythematosus.

OBJECTIVE: To evaluate the relationship between renal activity and quality of life (QOL) in patients with systemic lupus erythematosus (SLE). METHODS: Three hundred eighty-six patients completed annual Medical Outcomes Study Short Form-36 questionnaires and physicians completed the SLE Disease Activity Index and Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index. Concurrent association between renal activity and QOL was evaluated through regression models that adjusted for demographics and nonrenal disease activity and nonrenal damage. To characterize the longitudinal relationship between change in renal activity and change in QOL, all renal activity and QOL data over the entire study were used to estimate a linear trend within each individual patient through hierarchical modeling. RESULTS: In the regression model that assessed the association between renal activity and QOL, on average, each additional renal activity item fulfilled was associated with a 2.04-unit (95% CI 0.88, 3.24) decrease in the physical function subscale, a 5.28-unit (95% CI 2.76, 7.76) decrease in the role-physical subscale, a 2.24-unit (95% CI 0.72, 3.80) decrease in the social function subscale, and a 1.16-unit (95% CI 0.60, 1.72) decrease in the physical component summary score. In the hierarchical model, no association was observed between changes in renal activity and QOL. CONCLUSION: Patients with SLE and active renal disease concurrently experience a slightly poorer QOL than those without renal disease, especially in the physical domains. Because the confidence intervals were wide, we could not accurately estimate whether a longitudinal change in renal activity was associated with a change in QOL.

A quality indicator set for systemic lupus erythematosus.

OBJECTIVE: To systematically develop a quality indicator (QI) set for systemic lupus erythematosus (SLE). METHODS: We used a validated process that combined available scientific evidence and expert consensus to develop a QI set for SLE. We extracted 20 candidate indicators from a systematic literature review of clinical practice guidelines pertaining to SLE. An advisory panel revised and augmented these candidate indicators and, through 2 rounds of voting, arrived at 25 QIs. These QIs advanced to the next phase of the project, in which we employed a modification of the RAND/UCLA Appropriateness Method. A systematic review of the literature was performed for each QI, linking the proposed process of care to potential improved health outcomes. After reviewing this scientific evidence, a second interdisciplinary expert panel convened to discuss the evidence and provide final ratings on the validity and feasibility of each QI. RESULTS: The final expert panel rated 20 QIs as both valid and feasible. Areas covered included diagnosis, general preventive strategies (e.g., vaccinations, sun avoidance counseling, and screening for cardiovascular disease), osteoporosis prevention and treatment, drug toxicity monitoring, renal disease, and reproductive health. CONCLUSION: We employed a rigorous multistep approach with systematic literature reviews and 2 expert panels to develop QIs for SLE. This new set of indicators provides an opportunity to assess health care quality in patients with SLE and represents an initial step toward the important goal of improving care in this patient population.