Reliability assessment of the definition of ultrasound enthesitis in SpA: results of a large, multicentre, international, web-based study.

OBJECTIVES: To investigate the reliability of the OMERACT US Task Force definition of US enthesitis in SpA. METHODS: In this web exercise, based on the evaluation of 101 images and 39 clips of the main entheses of the lower limbs, the elementary components included in the OMERACT definition of US enthesitis in SpA (hypoechoic areas, entheseal thickening, power Doppler signal at the enthesis, enthesophytes/calcifications, bone erosions) were assessed by 47 rheumatologists from 37 rheumatology centres in 15 countries. Inter- and intra-observer reliability of the US components of enthesitis was calculated using Light's kappa, Cohen's kappa, Prevalence And Bias Adjusted Kappa (PABAK) and their 95% CIs. RESULTS: Bone erosions and power Doppler signal at the enthesis showed the highest overall inter-reliability [Light's kappa: 0.77 (0.76-0.78), 0.72 (0.71-0.73), respectively; PABAK: 0.86 (0.86-0.87), 0.73 (0.73-0.74), respectively], followed by enthesophytes/calcifications [Light's kappa: 0.65 (0.64-0.65), PABAK: 0.67 (0.67-0.68)]. This was moderate for entheseal thickening [Light's kappa: 0.41 (0.41-0.42), PABAK: 0.41 (0.40-0.42)], and fair for hypoechoic areas [Light's kappa: 0.37 (0.36-0.38); PABAK: 0.37 (0.37-0.38)]. A similar trend was observed in the intra-reliability exercise, although this was characterized by an overall higher degree of reliability for all US elementary components compared with the inter-observer evaluation. CONCLUSIONS: The results of this multicentre, international, web-based study show a good reliability of the OMERACT US definition of bone erosions, power Doppler signal at the enthesis and enthesophytes/calcifications. The low reliability of entheseal thickening and hypoechoic areas raises questions about the opportunity to revise the definition of these two major components for the US diagnosis of enthesitis.

The impact of different rheumatic diseases on health-related quality of life: a comparison with a selected sample of healthy individuals using SF-36 questionnaire, EQ-5D and SF-6D utility values.

BACKGROUND: Given the high prevalence of rheumatic diseases, there is a need to determine which conditions have the greatest impact on health-related quality of life (HRQoL). The main aim of this study was to explore the HRQoL scores among 14 different rheumatic diseases and to compare them with the results of a selecting sample of healthy controls. METHODS: 2633 patients of an ongoing cohort have been enrolled. Rheumatic diseases were classified into five diagnostic groups: inflammatory rheumatic diseases, connective tissue disorders, symptomatic peripheral osteoarthritis, soft tissue disorders, and osteoporosis. For comparison were used 649 healthy controls. The HRQoL was evaluated with the Medical Outcomes Study Short-Form 36 Health Survey (SF-36), the EuroQol five Dimensions (EQ-5D) questionnaire, and the Short-Form six Dimensions (SF-6D) questionnaire. RESULTS: The five major rheumatic disease groups, compared to healthy people, significantly impaired all eight health concepts of the SF-36 (p <0.0001). Similar results were found for EQ-5D and SF-6D. The patients with inflammatory rheumatic diseases have poorer self-reported health status than those without arthritis in all domains of living, but particularly with respect to scales measuring aspects of physical functioning or mobility, role limitation due to physical health problems and usual activities, and bodily pain. Rheumatoid arthritis had the largest negative impact on HRQoL, followed by fibromyalgia, vertebral fractures due to osteoporosis, hip osteoarthritis, and systemic sclerosis. CONCLUSIONS: Our results indicate that rheumatic diseases have a clearly detrimental effect on the HRQoL, and physical domain is more impaired than mental and social ones.

Identifying the symptom and functional domains in patients with fibromyalgia: results of a cross-sectional Internet-based survey in Italy.

OBJECTIVE: The aims of this cross-sectional study were to investigate the usefulness of using an Internet survey of patients with fibromyalgia in order to obtain information concerning symptoms and functionality and identify clusters of clinical features that can distinguish patient subsets. METHODS: An Internet website has been used to collect data. Fibromyalgia Impact Questionnaire Revised version, self-administered Fibromyalgia Activity Score, and Self-Administered Pain Scale were used as questionnaires. Hierarchical agglomerative clustering was applied to the data obtained in order to identify symptoms and functional-based subgroups. RESULTS: Three hundred and fifty-three patients completed the study (85.3% women). The highest scored items were those related to sleep quality, fatigue/energy, pain, stiffness, degree of tenderness, balance problems, and environmental sensitivity. A high proportion of patients reported pain in the neck (81.4%), upper back (70.1%), and lower back (83.2%). A three-cluster solution best fitted the data. The variables were significantly different (P<0.0001) among the three clusters: cluster 1 (117 patients) reflected the lowest average scores across all symptoms, cluster 3 (116 patients) the highest scores, and cluster 2 (120 patients) captured moderate symptom levels, with low depression and anxiety. CONCLUSION: Three subgroups of fibromyalgia samples in a large cohort of patients have been identified by using an Internet survey. This approach could provide rationale to support the study of individualized clinical evaluation and may be used to identify optimal treatment strategies.

Subclinical ultrasound synovitis in a particular joint is associated with ultrasound evidence of bone erosions in that same joint in rheumatoid patients in clinical remission.

OBJECTIVES: The main aim of this study was to investigate the relationship between ultrasound (US) findings indicative of joint inflammation and US features characterising bone erosions at joint level in patients with rheumatoid arthritis (RA) in clinical remission. METHODS: Twenty-four consecutive patients with RA in clinical remission according to EULAR criteria (DAS28<2.6) underwent a complete clinical assessment. An experienced sonographer blind to the clinical data performed the US examinations to detect and score signs of joint inflammation and bone erosions from second to fifth metacarpophalangeal (MCP) joints of both hands. All joints were scanned both on dorsal and volar aspects. The second and fifth MCP joints were scanned also in lateral aspects. RESULTS: The patients were mainly female (79.2%), with a mean age of 63.2 years ±12.3 standard deviation (SD) and a mean disease duration of 114.5 months ±53.9 SD. Half of the patients were rheumatoid factor positive and 45.8% were anti-citrullinated protein antibody positive. A total of 192 MCP joints and 480 aspects were assessed. Of these joints, 105 (54.7%) were found inflamed by grey-scale US, 57 (29.7%) were power Doppler (PD) positive, and bone erosions were detected in 42 (21.7%) joints. PD signal was found in 30 (53.6%) of the 56 eroded aspects and in only 41 (9.7%) out of the 424 aspects without bone erosions. Both the GS and PD mean scores were statistically higher in the joints with US bone erosions compared to those without erosions. CONCLUSIONS: A higher prevalence of PD signal was found in the joints where bone erosions were detected. This is the first study providing evidence supporting the association between US bone erosions and the persistence of subclinical inflammation in RA patients in clinical remission.

Effectiveness of a telemonitoring intensive strategy in early rheumatoid arthritis: comparison with the conventional management approach.

BACKGROUND: The advent of Internet and World Wide Web has created new perspectives toward interaction between patients and healthcare professionals. Telemonitoring patients with rheumatoid arthritis (RA) is an emerging concept to guide the collaborative management treatment and improve outcomes in patients. The objective of this study was to investigate whether an intensive treatment strategy, according to a telemonitoring protocol, is more effective than conventional management strategy in reaching remission and comprehensive disease control (CDC) after 1 year in early rheumatoid arthritis (ERA) patients. METHODS: Forty-four ERA patients were randomly allocated into two groups: the telemonitoring intensive strategy (TIS) group (group 1) or the conventional strategy (CS) group (group 2). Three patients refused to participate. In group 1 (n = 21), a remote monitoring system of disease activity, in combination with protocolised treatment adjustments aiming for remission was applied. In group 2 (n = 20), patients were treated according to daily clinical practice, with regular evaluation of disease activity, but without protocolised treatment adjustments. A telemedical care called "REmote TElemonitoring for MAnaging Rheumatologic Condition and HEaltcare programmes" (RETE-MARCHE), was developed to perform the remote monitoring. RESULTS: A higher percentage of patients in the TIS group achieved CDAI remission vs patients in the CS group (38.1 % vs 25 % at year 1, p <0.01). Time to achieve remission was significantly shorter in the group 1 than in the group 2, with a median of 20 weeks vs a median over 36-weeks (p <0.001). Concordantly, the patients in group 1 showed a greater improvement (p <0.001), compared with group 2 in terms of functional impairment (71.4 % vs 35 %) and radiological damage progression (23.8 % vs 10 %), resulting in a greater rate of CDC (19.4 % vs 5 %). CONCLUSIONS: According to our results, an intensive treatment strategy by telemonitoring leads to more effective disease remission and more rapid CDC than treatment according to conventional management strategy in ERA. TRIAL REGISTRATION NUMBER: ISRCTN13142685 Date of registration: March, 17(th) 2016.

Combined Thenar and Hypothenar Hammer Syndromes and Raynaud's Phenomenon Successfully Treated with Iloprost.

Thenar and hypothenar hammer syndromes are uncommon conditions characterised by digital ischemia of the hand as a result of repetitive trauma at level of the thenar and/or hypothenar eminence and damage to the radial and/or ulnar arteries, respectively. The symptoms are related to the mechanism of the trauma and a Raynaud's phenomenon can be predominant for a long time. The angiography is the "gold standard" imaging technique which allows to confirm the diagnosis. Therapeutic strategy depends on the type of the lesion and severity of symptoms and includes pharmacological (antithrombotic and thrombolytic drugs) and surgical treatments. The authors present a case of a 53-year-old man, carpenter by profession, with combined thenar and hypothenar hammer syndromes and Raynaud's phenomenon, successfully treated with a short course of intravenous infusion of iloprost.

Web/Internet-based telemonitoring of a randomized controlled trial evaluating the time-integrated effects of a 24-week multicomponent intervention on key health outcomes in patients with fibromyalgia.

OBJECTIVES: The aims of the study were to assess the efficacy of a multicomponent intervention and evaluate the feasibility and user acceptance of an internet-based home telemedical surveillance system for the evaluation of pain and other key health outcomes in patients with fibromyalgia (FM). METHODS: The study involved 76 FM patients who were randomised to usual care or the multicomponent exercise programme, which consisted of 24 twice-weekly sessions of combined aerobic, muscle strength training exercises and education. All the patients completed the revised version of the Fibromyalgia Impact Questionnaire (FIQR) and the self-administered Fibromyalgia Activity Score (FAS). A predefined website allowed authorised users to enter data via a personal computer (PC) and Internet browser. The differences between the groups were assessed using the Mann-Whitney U-test and Fisher's exact test, and the correlations were analysed using Spearman's rank correlation test. RESULTS: The multicomponent intervention led to a clinically relevant difference in improvement in comparison with the standard approach. It markedly improved the FIQR symptom subscale score, significantly increased the time-integrated area under the curve (AUC) of the FAS scores, and led to a greater benefit in terms of fatigue and the quality of sleep. The mean change in the AUC of the total FIQR score closely correlated with the changes in the AUC of the total FAS score. CONCLUSIONS: The multicomponent approach to FM was effective in treating the key symptoms and maintaining the improvements in the short term, and telemonitoring proved to be an easyto-use solution for patient-centred data acquisition.

Computer-aided quantification of interstitial lung disease from high resolution computed tomography images in systemic sclerosis: correlation with visual reader-based score and physiologic tests.

OBJECTIVE: To evaluate the performance of a computerized-aided method (CaM) for quantification of interstitial lung disease (ILD) in patients with systemic sclerosis and to determine its correlation with the conventional visual reader-based score (CoVR) and the pulmonary function tests (PFTs). METHODS: Seventy-nine patients were enrolled. All patients underwent chest high resolution computed tomography (HRCT) scored by two radiologists adopting the CoVR. All HRCT images were then analysed by a CaM using a DICOM software. The relationships among the lung segmentation analysis, the readers, and the PFTs results were calculated using linear regression analysis and Pearson's correlation. Receiver operating curve analysis was performed for determination of CaM extent threshold. RESULTS: A strong correlation between CaM and CoVR was observed (P < 0.0001). The CaM showed a significant negative correlation with forced vital capacity (FVC) (P < 0.0001) and the single breath carbon monoxide diffusing capacity of the lung (DLco) (P < 0.0001). A CaM optimal extent threshold of 20% represented the best compromise between sensitivity (75.6%) and specificity (97.4%). CONCLUSIONS: CaM quantification of SSc-ILD can be useful in the assessment of extent of lung disease and may provide reliable tool in daily clinical practice and clinical trials.

Construct validity and responsiveness of the simplified version of Ankylosing Spondylitis Disease Activity Score (SASDAS) for the evaluation of disease activity in axial spondyloarthritis.

BACKGROUND: Over the last decade, significant progresses have been achieved in the development and validation of new tools for the evaluation of disease activity in axial spondyloarthritis (SpA). Despite they play a key role in the assessment of these patients, the calculation scores are relatively complex and difficult to be quickly assessed in the busy daily clinical practice. OBJECTIVES: To test the construct validity of the Simplified Ankylosing Spondylitis Disease Activity Score (SADSAS) to define disease activity and compare its internal and external responsiveness with the Ankylosing Spondylitis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in patients with axial SpA. METHODS: The patient cohort comprised 397 consecutive axial SpA patients who had never been treated with tumor necrosis factor (TNF) blockers. Clinical and laboratory outcome assessments were performed at baseline, and at week 24. The following parameters were evaluated: BASDAI, ASDAS-CRP, ASDAS-ESR, and SASDAS. Construct convergent validity was evaluated by correlating SASDAS with ASDAS CRP/ESR, BASDAI, Bath Ankylosing Spondylitis Functional Index (BASFI) and EuroQol five-dimensional (EQ-5D) questionnaire. One hundred and fifty-six patients were observed longitudinally for 6 months. Responsiveness was assessed after six months of treatment with sulfasalazine (SSZ) or biologics. Internal responsiveness was evaluated by using the effect size (ES) and standardized response mean (SRM). External responsiveness was investigated by receiver operating characteristic (ROC) analysis. Change scores were compared by calculating paired t-test statistic for the difference. RESULTS: In testing for convergent validity a strong correlations (p < 0.0001) were observed between both SASDAS and ASDAS-ESR (r = 0.835), and ASDAS-CRP (r = 0.805). Strong correlations (p < 0.0001) were also found between SASDAS and BASDAI score (r = -0.886), SASDAS and BASFI scores (rho = 0.588) and SASDAS and EQ-5D scores (rho = -0.579). The cross-classification showed a significant overall agreement (defined as the percentage of observed exact agreements) for SASDAS vs ASDAS-ESR (weighted k = 0.704) and for SASDAS vs ASDAS-CRP (k = 0.661). The most efficient composite measure in detecting change was the ASDAS-CRP (ES 1.95 and SRM 0.97). The responsiveness of SASDAS was slightly higher to ASDAS-ESR with an ES of 1.62 and 1.33, and an SRM of 0.88 and 0.71, respectively. The BASDAI appear to be the less responsive (ES = 0.93 and SRM = 0.52). The area under ROC curve of the SASDAS gives similar results to those provided by ASDAS CRP/ESR. The score changes of all combinations were highly correlated (p < 0.0001). CONCLUSIONS: The new SASDAS is a highly effective measure in assessing disease activity and it showed comparable internal and external responsiveness with respect to the ASDAS ESR/CRP response criteria in patients with axial SpA. SASDAS is easy to calculate and, therefore, appear suitable for clinical decision making, epidemiologic research, and clinical trials.

Disease activity in psoriatic arthritis: comparison of the discriminative capacity and construct validity of six composite indices in a real world.

OBJECTIVE: To compare, "in a real world," the performance of the most common composite activity indices in a cohort of PsA patients. METHODS: A total of 171 PsA patients were involved. The following variables were evaluated: peripheral joint assessment, patient reported of pain, physician and patient assessments of disease activity, patient general health status, dactylitis digit count, Leeds Enthesitis Index, Health Assessment Questionnaire (HAQ), physical and mental component summary score of the Medical Outcome Survey (SF-36), Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). To measure the disease activity, the Disease Activity Score (DAS28-ESR and DAS28-CRP), Simple Disease Activity Index (SDAI), Composite Psoriatic Disease Activity Index (CPDAI), disease activity in psoriatic arthritis (DAPSA), and Psoriatic Arthritis Disease Activity Score (PASDAS) have been calculated. The criteria for minimal disease activity (MDA) and remission were applied as external criterion. RESULTS: The ROC were similar in all the composite measures. Only the CPDAI showed less discriminative ability. There was a high degree of correlation between all the indices (P < 0.0001). The highest correlations were between DAPSA and SDAI (rho = 0.996) and between DAPSA and DAS28-CRP (rho = 0.957). CPDAI, DAPSA, and PASDAS had the most stringent definitions of remission and MDA category. DAS28-ESR and DAS28-CRP had the highest proportions in remission and MDA. CONCLUSIONS: Although a good concurrent validity and discriminant capacity of six disease activity indices were observed, the proportions of patients classified in the disease activity levels differed. In particular, the rate of patients in remission was clearly different among the respective indices.

Ultrasonography of the salivary glands: the role of grey-scale and colour/power Doppler.

Over the last few years the use of ultrasonography (US) in the study of salivary glands is greatly increased due to its several advantages and undoubted diagnostic potential in detecting even minimal soft tissue changes in a wide range of pathological processes. Nowadays, there is general agreement in considering US as a useful complement to other imaging techniques, such as magnetic resonance, in providing an accurate assessment of the salivary glands especially in the study of tumour pathologies. US is also useful for the evaluation of inflammatory process affecting salivary glands (e.g. Sjögren's syndrome) where its accuracy and feasibility make it a reliable method. The useful combination of the US grey-scale and the colour/power Doppler technique provides more valuable details regarding the presence and degree of soft tissues blood perfusion and may be valuable in narrowing the differential diagnosis. This review provides an overview of the main US findings observed in a wide range of pathological processes that can affect salivary glands.

Searching for optimal rating scales in the Bath Ankylosing Spondylitis Functional Index (BASFI) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).

The comparison of the performance of the numerical rating scale (NRS) versus visual analog scale (VAS) in the Bath Ankylosing Spondylitis Functional Index (BASFI) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) showed that the 11-point NRS is psychometrically superior to the 10-cm VAS. This finding is in agreement with previous studies and the recommendation by the Assessment of SpondyloArthritis international Society. To illustrate the functioning of the response categories of both BASFI and BASDAI, we analyzed the rating scales (using the Rasch rating scale model) in patients with ankylosing spondylitis. Our results have shown that the 11 categories available in the 0-10 NRS version of both BASFI and BASDAI exceed the number of levels of a construct that participants can discriminate. This indicates the need for improving the metric quality of both rating scales by appropriately reducing the number of categories.

Validity of a computer-assisted manual segmentation software to quantify wrist erosion volume using computed tomography scans in rheumatoid arthritis.

BACKGROUND: To investigate the performance of conventional radiography (CR) for the detection of bone erosions of wrist in rheumatoid arthritis (RA) using multidetector computed tomography (CT) as the reference method and to evaluate the validity of a computer-assisted manual segmentation (outlining) technique to quantify erosion volume on CT scans. METHODS: Twenty five RA patients and six controls underwent CT and radiographic evaluation of the dominant wrist on the same day. CT was performed by using a 64 GE light Speed VCT power. Wrists images were evaluated separately and scored for the presence of erosions according to the Outcome Measures in Rheumatology Rheumatoid Arthritis MRI Scoring System (RAMRIS) and the Sharp/van der Heijde scoring method. Measurements of bone erosion volumes were obtained using OsiriX medical imaging software. The mean value of the volumes of the CT bone erosions detected at two readings was used to calculate inter-rater agreement. RESULTS: The overall sensitivity, specificity and accuracy of radiography for detecting erosions were 25.5%, 98.3% and 70.1%, respectively. Using computer-assisted manual segmentation (outlining) technique, erosion volume on CT measurements per subject was ranged from 0.001 cm³ to 2.01 cm³. Spearman's RAMRIS score of each wrist bones in all subjects (n = 25) were correlated with the total erosion volume on CT (p < 0.0001), with the ratio between erosion volume and the corresponding bone volume on a percentage basis (p < 0.0001). The total Sharp/van der Heijde erosion score of the all wrist bones was correlate with the RAMRIS score (p = 0.008). The intraclass correlation coefficients (ICC) for manual segmentation showed high agreement (ICC = 0.901). CONCLUSIONS: Considering CT as the reference method, CR showed very low sensitivity. A close correlation with CT erosion volumes supports the OMERACT RAMRIS erosion score as a semiquantitative measure of joint damage in RA. Although the computer-assisted manual segmentation can be beneficial for diagnostic decision in cross-sectional CT examinations of the wrist in RA, this technique will require further evaluation in terms of responsiveness.

Usability of an innovative and interactive electronic system for collection of patient-reported data in axial spondyloarthritis: comparison with the traditional paper-administered format.

OBJECTIVE: To evaluate the validity, in terms of the patients' acceptance, preference, feasibility and reliability of an innovative, interactive computerized system for collection of patient-reported outcome (PRO) data on axial SpA against the paper-and-pencil version. METHODS: Fifty-five patients with axial SpA completed both the touch screen and the paper-and-pencil set of questionnaires. A computerized touch-screen system, SPEAMonitor, was developed to capture PRO data. Variables recorded included demographic data, patient's assessment of general health status, BASDAI, BASFI, BASMI and acute-phase reactant levels. In order to assess the patient's acceptance of, preference for and feasibility of computer-based questionnaires, the participants filled in an additional questionnaire. The time taken to complete both formats was measured. In a further test-retest study, 25 patients were re-evaluated. RESULTS: The agreement between the paper-administered and computer touch-screen format of the BASFI, BASDAI questionnaires and the Ankylosing Spondylitis Disease Activity Scores was excellent. Intraclass correlation coefficients (ICCs) between data ranged from 0.90 to 0.96. Additionally the test-retest study showed a very good agreement between the scores for the two administrations (ICC ≥ 0.90). Age, computer experience and education level had no significant impact on the results. The computerized questionnaires were reported to be easier to use. The mean time spent completing the questionnaires on a touch screen was 5.1 min and on paper 7.9 min. CONCLUSION: Our newly developed computer-assisted touch-screen questionnaires for PRO in axial SpA were well accepted by patients, with good data quality, reliability and score agreement.

Psychometric characteristics of the Italian version of the revised Fibromyalgia Impact Questionnaire using classical test theory and Rasch analysis.

OBJECTIVES: The aim of this study was to perform a psychometric analysis of the Italian Fibromyalgia Impact Questionnaire Revised version (FIQR), using both classical test theory (CTT) and Rasch analysis (RA) in order to better analyse its construct validity and provide a rational basis for a possible improvement of its metric quality. METHODS: The study involved 503 patients with fibromyalgia (FM) (423 women and 80 men) with mean age of 51.3±10.1 years (range 19-74) and mean duration of symptoms of 11.1±8.7 years (range 1-30). All patients completed the Italian FIQR during their clinical visit. The translation and cultural adaptation process of the Italian FIQR followed the published guidelines and no local adjustments were made except for a slight adaptation of item 13 related to 'energy'. RESULTS: Factor Analysis revealed two salient dimensions: function (items 1-9) and symptoms (items 12-21). RA was thus performed on these two subscales. Rating scale diagnostics suggested collapsing the eleven rating categories of the scale into five. After combining these rating categories, RA showed that most items of each of the two subscales fitted the respective constructs to measure (MnSq 0.7-1.3). The reliability levels of the two subscales were higher than 0.80. CONCLUSIONS: This study provides psychometric evidence of the reliability, internal validity and two-dimensional structure of the FIQR in a FM population. Our results support the use of two separate subscales for 'function' and 'symptoms', and provide a useful starting point for further refinement of the scale.

Classical test theory and Rasch analysis validation of the Recent-Onset Arthritis Disability questionnaire in rheumatoid arthritis patients.

Disability has been identified as a core outcome measure in rheumatoid arthritis (RA). The aim of this study was to perform a comprehensive psychometric analysis of the Recent-Onset Arthritis Disability (ROAD) questionnaire in patients with RA. The questionnaire was completed by 583 patients with RA: 196 subjects participating in the NEW INDICES study and 387 subjects who were taking part in a long-term observational study. At confirmatory factor analysis for categorical data, data fit for a three-factor model was adequate to good (non-normed fit index = 0.98, comparative fit index = 0.99, root mean square error of approximation = 0.079, standardized root mean square residual = 0.047), with standardized item-to-factor loadings ranging from 0.60 to 0.90 and a cumulative explained variance of 83 %. The bifactor model of ROAD presented a clean independent cluster structure. The loadings in the unidimensional model were very similar to those on the general factor in the bifactor model. Rasch analysis showed a correct functioning of rating categories, a good fit of the data to the model for all three subscales, and satisfactory separation indexes and respective reliability (for both persons and items). This study, using both classical test theory and Rasch analysis methods, provides psychometric evidence of the reliability and internal and structural validity of ROAD in RA patients. Our results support the use of separate subscores for upper limb function, lower limb function, and activities of daily living/work, and the appropriateness of reporting an overall score (i.e., the mean of the three subscales).

Rasch analysis of the 22 knee injury and osteoarthritis outcome score-physical function items in Italian patients with knee osteoarthritis.

OBJECTIVES: To replicate previous Rasch analysis (RA) that yielded the 7-item Physical Function Short Form of the Knee Injury and Osteoarthritis Outcome Score (KOOS-PS7) in order to verify the consistency of the item selection process, and to analyze its main psychometric properties in a sample of Italian patients with osteoarthritis (OA). DESIGN: Methodological research on cross-sectional data from a convenience sample. SETTING: University hospital. PARTICIPANTS: Outpatients with symptomatic OA of the knee (N=200; women, 73%; mean age, 69.4y). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: The KOOS-PF22 (22 items comprising the 2 KOOS domains of activities of daily living and sport/recreation). Its dimensionality was investigated using exploratory factor analysis. RA was performed on KOOS-PF22, KOOS-PS7, and an item set (called KOOS-PS12) obtained by removing from KOOS-PF22 all misfitting items. RESULTS: KOOS-PF22 showed a 2-factor structure, with the first one largely prevailing. Ten of its 22 items did not fit the Rasch model, while item dependency was present in 7 item pairs. Five of 7 KOOS-PS7 items and all KOOS-PS12 items showed acceptable fit to the Rasch model. The person separation reliability was .79 for KOOS-PS7 and .90 for KOOS-PS12; Cronbach alpha was .81 for KOOS-PS7 and .92 for KOOS-PS12. CONCLUSIONS: RA was not able to replicate the selection process of the items included in KOOS-PS7. KOOS-PS7 reliability levels indicate that the instrument seems more useful for group decisions than for everyday clinical application in single patients. To achieve a short form of KOOS-PF22 valid for a wide spectrum of individuals with knee OA, further psychometric studies are warranted.

Very early rheumatoid arthritis as a predictor of remission: a multicentre real life prospective study.

BACKGROUND: To assess whether, in the real world of three early arthritis clinics, early referral could allow the best outcome, ie, remission, to be reached, and whether reaching the outcome was more dependent on therapy than on disease duration or vice versa. METHODS: 1795 patients with early arthritis (symptom duration≤12 months) were entered into a prospective follow-up study. 711 patients (39.6%) were diagnosed with rheumatoid arthritis (RA). Each RA patient was treated according to the local algorithm, in three tertiary referral centres (representing a small province, a medium sized province and a metropolitan area, respectively). Remission, defined using the disease activity score in 28 joints (DAS28<2.6) and American College of Rheumatology (ACR) criteria, was the major outcome evaluated at the 12-month follow-up. RESULTS: DAS28 remission was achieved in 34.3% (range 19.5-49%) of RA patients and ACR remission in 15.2% (range 8.5-20.6%). At the multivariate logistic regression analysis only two variables emerged as predictors of the major outcome: being in very early rheumatoid arthritis (VERA; less than 12 weeks symptom duration at the time of first treatment) and being on disease-modifying antirheumatic drugs (DMARD) within 3 months from disease onset. Among RA patients in remission, only 10% of VERA subjects received an anti-TNF blocker compared with 32.2% of non-VERA patients (p=0.002, OR 0.23, 95% CI 0.09 to 0.64). CONCLUSIONS: In a real-world setting, the 12 weeks disease duration and an early intervention with DMARD represent the most significant opportunities to reach the major outcome, ie, remission of RA. Moreover, VERA represents a window of opportunity in terms of cost saving.

The comparative responsiveness of the patient self-report questionnaires and composite disease indices for assessing rheumatoid arthritis activity in routine care.

OBJECTIVES: This paper aims to evaluate the internal and external responsiveness of the patient self-report questionnaires, comparatively to the traditional composite indices to assess the activity of rheumatoid arthritis (RA) in everyday practice. METHODS: One hundred and ninety-one RA out-patients completed the clinical arthritis activity (PRO-CLARA) index, the rheumatoid arthritis disease activity index (RADAI), the routine assessment of patient index data (RAPID3), and the patient activity score (PAS). Simultaneously, the disease activity score-28 joints based on CRP (DAS28-CRP) and ESR (DAS28-ESR), the simplified disease activity index (SDAI), the clinical disease activity index (CDAI), and the mean overall index for RA (MOI-RA) were computed for each patient. Sensitivity to change was assessed after 6 months of treatment with disease-modifying anti-rheumatic drugs or biologics. Internal responsiveness was evaluated with the effect size (ES) and standardised response mean (SRM). External responsiveness was investigated by receiver operating characteristic (ROC), in categories of respondents, stratified according to the response on an item on change in overall health. In addition, change scores were compared by calculating correlation coefficients. RESULTS: No significant differences in internal and external responsiveness were found between self-report questionnaires and composite indices. The internal responsiveness of the self-report questionnaires and composite measures was wide, with SRM and ES ranging from 1.03 (RADAI) to 1.80 (DAS28-ESR) and higher than that of the each individual measures. The responsiveness of the PRO-CLARA was equal to the DAS28-ESR, DAS28-CRP, SDAI or MOI-RA, but better than the CDAI. The RADAI and PAS were less responsive than the PRO-CLARA and RAPID3. The area under ROC curve of the PRO-CLARA gives identical results to those provided by other comparator composite indices. The score changes of all combinations were highly correlated (p<0.0001). CONCLUSIONS: The self-report questionnaires showed comparable internal and external responsiveness to the composite activity scores and allow for the detection of rheumatoid disease activity. They appear suitable for clinical decision making, epidemiologic research and clinical trials. Further longitudinal studies are needed to validate these encouraging results.

CS injection of tenosynovitis in patients with chronic inflammatory arthritis: the role of US.

OBJECTIVE: The main aim of this study was to investigate the short-term efficacy of CS loco-regional treatment performed under US guidance in tenosynovitis of patients with chronic inflammatory arthritis. METHODS: Thirty consecutive patients affected by chronic arthritis and with clinical suspicion of tenosynovitis were recruited to undergo US assessment. In the sonographically proven cases, US-guided CS injection was performed. A visual analogue scale for pain (ranging from 0 to 10) and a tenderness score (ranging from 0 to 3) were used for the clinical evaluation. Sonographic pathological findings indicative of tenosynovitis were scored using a semi-quantitative 4-grade scoring system, for both grey-scale and power Doppler US, at baseline and during a follow-up visit at 2 weeks after the CS injection. RESULTS: In 21 (70%) of 30 patients, the clinical suspicion of tenosynovitis was confirmed (9 with RA, 11 with PsA and 1 with ReA). In the other nine patients, US revealed synovitis of the adjacent joints, bursitis, oedema of the s.c. tissue or a partial tear. In all cases the appropriate needle placement and subsequent CS injection into the tendon sheath were obtained with US confirmation. A significant reduction in all clinical and sonographic scorings was found during the follow-up visit. CONCLUSIONS: The present study shows the efficacy of US-guided peritendinous CS injections in the management of patients with chronic inflammatory arthritis presenting as US-proven tenosynovitis.