Development of patient-centred standards of care for osteoarthritis in Europe: the eumusc.net-project.

OBJECTIVE: The eumusc.net project is an initiative founded by the European Community and the European League Against Rheumatism. One aim of the project was to facilitate equal standards for musculoskeletal health across Europe. The aim of this work-package was to develop patient-centred and consensus based standards of care (SOC) for osteoarthritis (OA), which should be available in a professional and a patient version. METHODS: A systematic review concerning guidelines dealing with OA was conducted. Furthermore, experts in musculoskeletal diseases were contacted to ensure that 'grey' literature was not excluded. Documents that fulfilled predefined inclusion/exclusion criteria were included and all interventions for OA were extracted and categorised. Based on this list of interventions, a three round Delphi exercise with an international and multidisciplinary expert panel, including patient research partners, was performed to achieve expert consensus. RESULTS: Six documents were included and used for further analysis. Out of them, 46 interventions have been extracted and 10 consensus based SOC were formulated. In addition, a patient version, written in a lay-understandable wording and in the format of checklist questions was developed. An example is SOC 5: "People with OA should achieve optimal pain control using pharmacological and non-pharmacological means." The matching patient-centred checklist question reads: "Do I know how to control pain associated with OA?" CONCLUSIONS: The SOC for OA will be available in the 23 languages of the European Union to enhance unified information to patients and professionals and to further harmonise the treatment/care of OA within Europe.

Which patients improve the most after arthritis rehabilitation? A study of predictors in patients with inflammatory arthritis in Northern Europe, the STAR-ETIC collaboration.

OBJECTIVE: To study health-related quality of life (HRQoL) in arthritis rehabilitation performed by multidisciplinary teams in patients with chronic inflammatory arthritis. Predictors of change in health-related quality of life and the proportion of patients with clinical improvement were investigated. DESIGN: Multicentre prospective observational study in 4 European countries. METHODS: HRQoL was measured with the European Quality 5 Dimensions (EQ-5D) and the Short Form 36 Health Survey (SF-36) in 731 patients who underwent multidisciplinary rehabilitation. Potential predictors were physical functioning (Health Assessment Questionnaire (HAQ)), self-efficacy (Arthritis Self Efficacy Scale (ASES)), psychological health (Hopkins Symptom Check List (HSCL-25)), pain/fatigue (numeric rating scales (NRS)), age, sex, diagnosis, comorbidity, education, clinical setting and change of medication during rehabilitation. Analysis of covariance (ANCOVA) was used to assess for potential predictors and interactions. The minimal important differences for HRQoL were analysed. RESULTS: Reporting worse function (b 0.05, p = 0.01), less psychological well-being (b 0.09, p = 0.000), and experiencing more pain (b 0.03, p = 0.000) or fatigue (b 0.02, p = 0.000) at admission predicted improved HRQoL. Change in medication during rehabilitation (b 0.08, p = 0.013) was associated with greater improvement in HRQoL. These EQ-5D findings were supported by SF-36 findings. Positive minimal important differences were noted in 46% (EQ-5D) and 23-47% (SF-36 subscales) of the patients. CONCLUSION: Patients with more severe symptoms experienced the largest gain in HRQoL post-intervention. The results of this study are of value for selecting the right patients for rheumatological team rehabilitation.

Development of healthcare quality indicators for rheumatoid arthritis in Europe: the eumusc.net project.

BACKGROUND: Eumusc.net (http://www.eumusc.net) is a European project supported by the EU and European League Against Rheumatism to improve musculoskeletal care in Europe. OBJECTIVE: To develop patient-centred healthcare quality indicators (HCQIs) for healthcare provision for rheumatoid arthritis (RA) patients. METHODS: Based on a systematic literature search, existing HCQIs for RA were identified and their contents analysed and categorised referring to a list of 16 standards of care developed within the eumusc.net. An international expert panel comprising 14 healthcare providers and two patient representatives added topics and during repeated Delphi processes by email ranked the topics and rephrased suggested HCQIs with the preliminary set being established during a second expert group meeting. After an audit process by rheumatology units (including academic centres) in six countries (The Netherlands, Norway, Romania, Italy, Austria and Sweden), a final version of the HCQIs was established. RESULTS: 56 possible topics for HCQIs were processed resulting in a final set of HCQIs for RA (n=14) including two for structure (patient information and calculation of composite scores), 11 for process (eg, access to care, assessments, and pharmacological and non-pharmacological treatments) and one for outcome (effect of treatment on disease activity). They included definitions to be used in clinical practice and also by patients. Further, the numerators and the denominators for each HCQI were defined. CONCLUSIONS: A set of 14 patient-centred HCQIs for RA was developed to be used in quality improvement and bench marking in countries across Europe.

What's in the black box of arthritis rehabilitation? A comparison of rehabilitation practice for patients with inflammatory arthritis in northern Europe.

BACKGROUND: In evaluating complex interventions, it is a challenge for researchers to provide transparent reporting of the intervention content with sufficient detail and clarity such that effects can be compared across studies or countries. OBJECTIVE: To describe and compare the content of current rehabilitation for patients with inflammatory arthritis across 4 northern European countries. PATIENTS AND METHODS: A total of 731 patients with inflammatory rheumatic diseases participated in a multicentre, longitudinal observational study carried out in Sweden, The Netherlands, Denmark and Norway. Data on context, structure and process were reported by patients and teams at the different participating study sites according to the Scandinavian Team Arthritis Register-European Team Intiative for Care Research (STAR-ETIC) framework. RESULTS: Although large similarities were found in the context, there were important differences between the Netherlands and the Scandinavian countries. Regarding structure, there were considerable differences in the length of the rehabilitation period across settings and countries. The most evident differences concerned process variables, especially the type and dosage of individual treatment modalities. CONCLUSION: The variation in important aspects of arthritis rehabilitation found in the present study underline the need for transparent and standardized description of these variables when comparing effects across settings and countries. A standardized description of current practice can be achieved by the STAR-ETIC framework.

Health care quality indicators on the management of rheumatoid arthritis and osteoarthritis: a literature review.

OBJECTIVE: To make an inventory of quality and content of currently available and published sets of health care quality indicators (HCQIs) for RA and OA. METHODS: A systematic review was performed for documents on the development and/or a description of HCQIs for the management of patients with RA and/or OA, using the PubMed, EMBASE, Web of Science, Cochrane and CINAHL databases up to 1 December 2010 and official websites of arthritis organizations. The following data were extracted: general characteristics, contents and quality of developmental process (six aspects related to the definition of target, target group and stakeholders, patient involvement, description of development and test of validity). RESULTS: The search yielded 498 potentially eligible references and two websites, with ultimately six original HCQI sets for RA and/or OA being identified (one for RA and OA, two for OA and three for RA). The number of HCQI ranged from 7 to 27, with the majority being process indicators. No conflicting indicators between the HCQI sets for one condition were seen. Concerning the quality of the developmental process, all six sets lacked patient involvement. CONCLUSION: Only a limited number of HCQI sets for the management of OA and RA are available, mainly including process indicators. The developmental process was methodologically suboptimal in all cases. As improvement of health care quality is an ongoing process, there is a need for development of HCQIs covering different aspects of health care quality (structure, process and outcome) and using appropriate methodology.

Differences in physical activity patterns in patients with spondylarthritis.

OBJECTIVE: To study patient-reported physical activity in patients with spondylarthritis (SpA) and possible differences in physical activity patterns between the SpA subtypes and sexes. METHODS: In 2009, a questionnaire including inquiries concerning physical activity was sent to patients with a SpA diagnosis (n = 3,711). The World Health Organization (WHO) global recommendations of physical activity for health requiring 150 minutes of moderate-intensity physical activity (MI-PA) or 75 minutes of vigorous-intensity physical activity (VI-PA) per week were used as recommended levels. Standardized risk ratios (RRs) were calculated by using physical activity data from the Swedish population. The association within the SpA group between sex, age, disease-related variables, anxiety, and depression and meeting recommended levels of MI-PA and VI-PA (dependent variables) was studied with multivariate analysis. RESULTS: A total of 2,167 patients with SpA (48% men, mean ± SD age 55 ± 14 years) responded to the questionnaire. Sixty-eight percent of the patients met the WHO recommendations, more frequently in women than in men (70% versus 66%). The recommendations were more often met in the SpA group (RR 1.09, 95% confidence interval [95% CI] 1.04-1.15) compared with the Swedish population. There was a tendency for young women to meet the WHO recommendations less often than the Swedish population (RR 0.94, 95% CI 0.63-1.25). Different factors were found to influence whether the patients were exercising with a moderate or vigorous intensity. CONCLUSION: Seven of 10 patients with SpA met the WHO recommendations of physical activity for health, but we found sex and disease subtype differences. This information can be useful in clinical practice when coaching patients to have a healthier lifestyle.

Cultural adaptation, validity, reliability and responsiveness of the Swedish version of the effective musculoskeletal consumer scale (EC-17).

BACKGROUND: Endorsed by the Outcome MEasures in Rheumatoid Arthritis in Clinical Trials (OMERACT) group, The Effective Consumer Scale (EC-17) was developed in English for patients with musculoskeletal diseases to assess the skills and perceptions important for participating in and managing health care. The objective of this study was culturally to adapt the questionnaire into Swedish and to study its psychometric properties. METHODS: After translation of the questionnaire into Swedish, two different groups of outpatients from two specialist rheumatology departments participated in the study. Face validity was assessed, together with internal consistency, test-retest and responsiveness of the questionnaire. Construct validity was assessed using the Arthritis Self-Efficacy Scale (ASES), and responsiveness to a five day educational intervention was analysed using the standardized response mean (SRM). RESULTS: Analyses were based on 124 patients with inflammatory rheumatic diseases, of whom 50 attended the intervention. Data quality met the requirements, with missing values <5%, and floor and ceiling effects <15%. Item total correlations were all >0.4, ranging from 0.49 to 0.88. Cronbach's alpha was 0.93 and 0.95 for the two groups. The test-retest correlation (ICC2.1) was 0.94, and there was a significant improvement as a result of the intervention, with an SRM of 0.43. However, the questionnaire had a higher construct validity with the ASES subscale 'other symptoms' than hypothesized a priori (r(s) 0.75). CONCLUSION: The Swedish version of the EC-17 met the required recommendations for face validity, internal consistency, test-retest reliability and responsiveness. Its construct validity needs to be further established, and the questionnaire needs further testing in different groups of patients and in different interventions.

Cost of illness from the public payers' perspective in patients with ankylosing spondylitis in rheumatological care.

OBJECTIVE: To estimate the incremental costs to public payers for patients with ankylosing spondylitis (AS) of working age compared with reference subjects from the general population. METHODS: We investigated total costs for 3 years (2005-2007) in 116 outpatients under 66 years of age with AS attending rheumatological care in Malmö, Sweden. Mean (SD) age was 46 (11) years and mean (SD) disease duration was 24 (11) years. Two subjects per AS patient matched for age, sex, and residential area were selected from the Population Register to serve as a reference group. We retrieved data concerning sick leave, prescription drugs, and healthcare consumption from Swedish health-cost registers by the unique personal identification numbers. RESULTS: The mean total cost for the 3-year period 2005-2007 was US $37,095 (SD $30,091) for patients with AS, and $11,071 (SD $22,340) for the reference group. The mean indirect cost was $19,618 and $5905, respectively. Mean cost for healthcare was $8998 for the AS patients and $4187 for the reference subjects, and mean cost for drugs was $8479 and $979, respectively. The patients with AS treated with biological therapy constituted 80% of the total drug cost, but just 40% of the cost for disability pension. CONCLUSION: Patients with AS had 3-fold increase in costs compared to reference subjects from the general population, and the drug costs were almost 10 times as high. Production losses (indirect cost) represented more than half of total cost (53%).

Sleepiness or fatigue? Can we detect treatable causes of tiredness in primary Sjögren's syndrome?

OBJECTIVE: To study the prevalence of fatigue and daytime sleepiness in primary SS (pSS) and analyse predicting sleep disturbing factors and other potential determinants of fatigue and sleepiness. METHOD: Seventy-two consecutive pSS patients and 59 age-matched healthy controls were compared. Assessment instruments were profile of fatigue (ProF), visual analogue scale fatigue, Epworth Sleepiness Scale (ESS), Hospital Anxiety and Depression Scale, restless legs syndrome (RLS) Diagnostic Criteria and Lund University Sleep Questionnaire. In addition, markers of immune disturbance, inflammation and disease activity using the European League Against Rheumatism SS Disease Activity Index were analysed in patients. RESULTS: Fatigue, especially somatic fatigue, is the main problem for pSS patients. Sleepiness is a minor problem. Patients had significantly more often anxiety, nocturia and woke up more frequently during the night than controls. The factors that predicted daytime fatigue in pSS patients were anxiety and nightly awakenings due to pain. Nocturia was frequent but was not associated with fatigue or sleepiness. RLS, depression and sicca symptoms contributed to fatigue in the univariate regression analysis only. CONCLUSIONS: This is the first study demonstrating not only the presence of disturbed sleep, but also that nightly musculoskeletal pain and other sleep disturbing factors and anxiety significantly influence fatigue. Management strategies aimed at these aspects should therefore be included in future trials for treatment of fatigue in pSS.

Patients with ankylosing spondylitis have increased sick leave--a registry-based case-control study over 7 yrs.

OBJECTIVES: Using prospectively collected registry data to investigate sick leave (sickness benefit and sickness compensation) over a 7-yr period in patients with AS in comparison with population-based controls matched for age, sex and residential area. METHODS: We investigated 122 (21 women and 101 men) outpatients with AS in South Sweden, born 1942 or later, from rheumatology specialist care for their sick leave during a 7-yr period. Mean (S.D.) age was 43 (11) yrs and mean (S.D.) disease duration was 20 (11) yrs. Two controls per case, matched for age, sex and residential area were selected from the Swedish National Population Register. Data concerning sick leave for cases and controls, based on the subjects' unique 10-digit personal identification number, were retrieved from the national register of the Swedish Social Insurance Agency. RESULTS: More AS patients than controls were registered for sickness benefit (52 vs 36%, P < 0.01) and sickness compensation (42 vs 11%, P < 0.001). Cases had an increased risk for sick leave compared with controls with a relative risk of 1.8; 95% CI 1.5, 2.1; and cases had more days with sick leave than controls (median number of more days per year 30; 95% CI 2, 72). CONCLUSIONS: Using the Swedish Social Insurance Agency's registers for sick leave, we found that patients with AS in rheumatology specialist care in South Sweden have an increased level of sick leave compared with controls. These population-based registers have a great potential for studies of the effects of different interventions on sick leave.

The role of exercise in the rehabilitation of patients with systemic lupus erythematosus and patients with primary Sjögren's syndrome.

PURPOSE OF REVIEW: The purpose of this review is to present an update on the evidence-based effects of exercise in systemic lupus erythematosus and in primary Sjögren's syndrome. RECENT FINDINGS: Physical capacity is reduced in both systemic lupus erythematosus and primary Sjögren's syndrome and fatigue is a dominating and disabling symptom in both conditions. The documentation on the effect of exercise on the rehabilitation of patients with systemic lupus erythematosus and primary Sjögren's syndrome is sparse; the studies are few and the sample sizes often small. The available studies indicate that patients with systemic lupus erythematosus of mild to moderate disease activity as well as patients with primary Sjögren's syndrome benefit from exercise of moderate to high intensity. Positive effects can be expected with regard to aerobic capacity, fatigue, physical function and depression. SUMMARY: There is reason to believe that exercise should be included in the rehabilitation of patients with mild to moderate systemic lupus erythematosus and patients with primary Sjögren's syndrome. Further research is needed and should aim to evaluate the effect of exercise on groups with varying degree of disease severity and to document the long-term impact on the disease.

Physical capacity in women with primary Sjögren's syndrome: a controlled study.

OBJECTIVE: To examine physical capacity (aerobic capacity, joint mobility, muscle function, and standing balance) in women with primary Sjögren's syndrome (primary SS) and to examine the correlation of aerobic capacity with fatigue, functional disability, and mental aspects (anxiety and depression). METHODS: Fifty-one women who fulfilled the European Community criteria for primary SS and who had anti-SSA/SSB antibodies or a positive lip biopsy were compared with 51 age-matched controls. Physical capacity, fatigue, functional disability, anxiety, and depression were investigated by means of questionnaires and clinical examinations. RESULTS: The women with primary SS had significantly decreased aerobic capacity (VO(2max) = 28.7 versus 32.4 ml/kg/minute; P = 0.013), shoulder mobility (58 versus 59 scale points; P = 0.003), grip strength (214 versus 259 N; P = 0.000), isokinetic strength of the knee flexors (51 versus 56 Nm; P = 0.049), endurance of the knee flexors (620 versus 712 J; P = 0.008), and standing balance (25 versus 28 seconds; P = 0.006) when compared with the reference group. For the primary SS patients, greater effort was needed to carry out the test of aerobic capacity, and they experienced more pain during the shoulder mobility test. Aerobic capacity correlated with the fatigue experienced (r = -0.33, P = 0.022) but not with functional disability or mental aspects. CONCLUSION: The results indicate that women with primary SS have decreased physical capacity, which may be related to the experience of fatigue.