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The purposes of this study were to analyse and compare aspects of validity (concurrent and discriminant) of the two widely used indirect utility instruments, the EuroQol-5D (EQ-5D) and the Short Form-6D (SF-6D) in a representative cohort of patients with rheumatoid arthritis (RA).Five hundred and eighty-three consecutive adult patients (435 women, 148 men) with RA and referred to the outpatient Clinic were evaluated. Patients were asked to complete EQ-5D and SF-36. SF-6D utility scores were calculated using the eight mean SF-36 scores, according to published algorithms. Disease-related characteristics included disease duration, co-morbidities, a measure for disease activity [Disease Activity Score-28 joint (DAS28)] and for radiographical damage (Sharp van der Heijde scoring method, SHS). The agreement between the utility instruments was evaluated by Bland-Altman analysis. Construct validity was assessed using the Kruskal-Wallis test, Mann-Whitney U-test, Spearman's correlations, and receiver operating characteristic (ROC) curves. Multivariate analyses were used to assess the relationship among HRQoL and disease-related characteristics and socio-demographic data.A comparison of means showed that SF-6D values exceeded EQ-5D values (p0.0001). Agreement between both measures was only moderate. Utility scores and domains and summary scores of the SF-36 were highly correlated. The EQ-5D and SF-6D both detected change in different health status (0.0001). The discriminatory power of both indexes was good, without significant difference, with an AUC of 0.869 and 0.820, respectively for EQ-5D and SF-6D. The EQ-5D and SF-6D both detected change over different health status among RA patients (both al level of p0.0001) although EQ-5D was more efficient in detecting differences between groups in almost all cases. Comparison of EQ-5D and SF-6D scores within VAS groups showed that, for less healthy individuals (VAS scores 0-50), the median EQ-5D score was significantly lower than the median SF-6D score. The multivariate regression models for EQ-5D and SF-6D included both SHS and DAS28 (p=0.0001). The relative contribution of these domains differed substantially between patients with short and long standing disease duration. The presence of multiple chronic conditions also appeared to contribute to reduce the levels of utility of both instruments.Although EQ-5D and SF-6D appeared to measure similar constructs, these instruments are quite different from each other in the assessment of RA. For worse health status the median EQ-5D scores were significantly lower than the median SF-6D scores. Moreover, EQ-5D and SF-6D appeared both significantly influenced by disease activity, radiological damage and co-morbidity. For that reason, we advise caution in the employment of these preference-based instruments, especially in RA patients with severe disease.

All of the specialists who deal in some way with fibromyalgia (FM) broadly agree that physical reconditioning programmes are useful, but it is not yet clear what type of physical activity is the most appropriate for different subsets of patients. The aim of this review was to examine the randomised controlled trials (RCTs) published between 1985 and August 2010 whose outcome measures indicate the effectiveness of different types of physical exercise (PE) on the main health domains affected by FM: pain, and physical and mental function. Studies that simultaneously used different types of PE or multimodal treatment strategies were excluded from the analysis, as were those in which the primary and secondary endpoints prevented any assessment of treatment efficacy in all three health domains. Twenty-seven studies were selected: 15 considered land-based physical aerobic exercise (PAE); seven exercises in water; and five muscle strengthening exercise (MSE). There was substantial uniformity in assessing the effectiveness of land- or water-based PAE and MSE in improving aerobic physical fitness (PF) and functional state. Water-based PAE offers some advantages over similarly intense land-based PAE in reducing spontaneous pain and improving depressive symptoms, but the data are insufficient to establish its overall superiority. Regardless of method, the latest findings concerning the neurophysiology of nociception indicate the fundamental importance of assigning workloads that do not exacerbate post-exercise pain.

The objective of this study is to assess cost-effectiveness of different biologic strategies in patients with moderate-to-severe active RA after an insufficient response to anti-TNF agents within the context of the Italian healthcare system.Simulation models were developed allowing for potential biologic therapy switch at each 6-month time point in case of an insufficient response to the previous biologic agent. Biologic treatments included etanercept, abatacept, adalimumab, rituximab or infliximab. Effectiveness criteria for these models were defined as achieving a state of low disease activity (LDAS) [DAS28 ≤3.2] or remission (RS) [DAS282.6]. Monte-Carlo simulations were performed for each sequence to manage data variability.The biologic treatment sequence using abatacept after an insufficient response to a first anti-TNF agent appeared significantly more efficacious over 2 years (102 days in LDAS) compared to rituximab (82 days in LDAS). The sequence using abatacept after 2 anti-TNF agents appeared significantly more efficacious (63 days in LDAS) compared to using a third anti-TNF agent (32 days in LDAS). Mean cost-effectiveness ratios showed significantly lower costs per day in LDAS with abatacept used after one anti-TNF agent (€376) compared to rituximab (€456). The sequence using abatacept after 2 anti-TNF agents was also more cost-effective (€642 per day in LDAS) versus a sequential use of anti-TNF therapies (€1164 per day in LDAS). All comparisons were confirmed when using the remission effectiveness criteria.The results of this health economics modelling study suggest that the biologic treatment sequence using abatacept after an insufficient response to a first anti-TNF agent appears significantly more effective and cost-effective versus a similar sequence using rituximab for achieving remission or LDAS. The results also indicate that in the case of an insufficient reponse to 2 anti-TNF agents, abatacept appears more effective and cost-effective than using a 3rd anti-TNF agent.

The ability to predict the development of rheumatoid arthritis (RA) in patients with an early-onset undifferentiated arthritis (UA) is highly required if the remission or an adequate response to the treatment are the main goal. The aim of the study was to develop a predictive rule combining clinical variables, serological biomarkers and power Doppler ultrasonography (PDUS) for the progression from an early-onset UA to RA in daily rheumatological practice.A prediction rule was developed after a 12 months study of 149 adult patients with a recent-onset UA. The combination of routine assessment variables and PDUS findings was investigated. Logistic regression analysis was performed to identify the independent factors for the development of RA and global predictive score was calculated. The score of the predictive rule ranged from 0 to 10. The area under the receiver operating characteristic curve was used to evaluate the diagnostic performance of the rule. The post-test probability (post-TP) was evaluated using the Bayes theorem.Sixty-two patients (41.6%) developed a RA. The rule demonstrated excellent discriminative ability, with an AUC of 0.919 (p=0.0001). With the optimal cut-off point of 5, sensitivity was 89.9%, specificity was 88.6% and positive likelihood ratio was 7.89. If a threshold of 6.5 was applied a higher value of specificity (97.7%) was obtained, but sensitivity (47.6%) decreased. The post-TP value of the two different cut-off points mentioned above were 62% and 80%, respectively.Our predictive rule, which includes PDUS assessment, revealed an excellent discriminative ability for assessing the likelihood of development of RA in patients with an early-onset UA. Further studies are required to confirm the results and to tailor a therapeutic approach in patients with an early-onset UA.

To compare health-related quality of life (HRQL) in fibromyalgia (FM) patients with that of patients with rheumatoid arthritis (RA) and the general population, and investigate if the factors are associated with the greater impact of FM.This cross-sectional study involved 380 patients with FM, 693 patients with RA and 1579 healthy controls. HRQL was evaluated using the Medical Outcome Study Short-Form 36 (SF-36), and the measures included disease-related characteristics, demographic variables and comorbidities. S-scores were calculated for comparisons with the norm, and multivariate analyses were used to assess the relationships between HRQL and clinical and demographic variables.In comparison with the general population, the FM patients showed significant impairment in relation to all of the eight scales of the SF-36 (p0.0001), as well as the physical and mental component summary scores (PCS and MCS) (p0.0001). The mean PCS and MCS of the FM patients were 38.5 (SD=6.9) and 32.8 (SD=10.9), whereas those of the RA patients were 33.5 (SD=6.4) (p0.01) and 40.2 (SD=11.9) (p0.001). The dimensions typically affected by FM were vitality (s-score -1.61), mental health (s-score -1.46) and general health (s-score-1.47), whereas physical functioning (s-score-1.63) and role limitations due to physical function (s -score -0.94) were more impaired in the RA patients; the bodily pain scores were similar in the two groups. The PCS was lower than the MCS in the RA patients (s-scores -1.80 vs. -0.62), but the two scores were similar in the FM patients (s-scores -1.20 vs. -1.08). Multiple regression models showed that the physical component of the SF-36 was associated with widespread pain (the SAPS score) (p0.0001), educational level (p=0.0017), and the body mass index (p=0.007), and the mental component was associated with the widespread pain (p=0.0005), sleep abnormalities (p=0.0033), physical function (p=0.015), fatigue (p=0.029), gender (p=0.014) and a low educational level (p=0.0007).Patients with FM see the disease as having a worse health than RA patients and the general population, especially in terms of mental health.

The Disease Activity Score including 28 joints (DAS28) and the Clinical Disease Activity Index (CDAI) were developed in order to provide a quantifiable measure of rheumatoid arthritis (RA) activity. The aim of this study was to evaluate the validity and internal consistency reliability for DAS28 and CDAI in patients with RA seen by rheumatologists in usual clinical care. We also compared proposed categories of high, moderate, and low activity and remission according to both scores.A sample of 2864 RA patients (2267 female, 597 male; mean age 58.5 yr, range 18-88 yr) were enrolled in this cross-sectional community-based study. Disease activity was assessed in each patient based on DAS28 and CDAI. Patients completed the Health Assessment Questionnaire (HAQ). Statistical evaluation was carried out by applying the Cronbach's values and principal component analysis (internal consistency reliability), the Pearson's coefficients, ANOVA and kappa statistic (convergent validity) and receiver operating characteristic (ROC) curve analysis (discriminant validity).Internal consistency testing of both scores indicated a reasonable difference, with Cronbach's alpha slightly higher for the DAS28. Interestingly, factor analysis revealed that the DAS28 constitutes a monocomponent measure in RA. Linear regression analysis showed a significant correlation between DAS28 and CDAI (p0.0001). In addition, the DAS28 and CDAI were well correlated with HAQ (both at p level of0.0001). The discriminatory power of both indices was good, without significant difference, but our results showed wide differences in both moderate/high disease activity and remission percentages (k=0.418).DAS28 and CDAI are valid and simple acceptable ways to measure RA activity in the clinical practice, but disease activity categorized by these indices differ considerably. Further research is needed to resolve this issue.

To evaluate the psychometric properties of an index based on 3 patient reported outcomes measures, termed PRO-CLinical ARthritis Activity (PRO-CLARA), in order to facilitate rapid and easy rheumatoid arthritis (RA) activity assessment in daily routine.196 patients partially or not responding to disease modifying anti-rheumatic drugs (DMARDs), consented to participate in a multicentre cross-sectional study. For the evaluation of the psychometric properties of the PRO-CLARA, this population has been compared to another cohort of 247 outpatients with RA who were participating in a long-term observational study and who satisfying minimal disease activity and remission definitions. All patients completed the PRO-CLARA, combining patient's physical function, self-administered tender joint count and perception of global health status into a single measure of disease activity. Additional comparator composite indices were analysed. Internal consistency was assessed with Cronbach's alpha coefficient. A confirmatory factor analysis was carried out to test factor structure. Concurrent validity was analyzed using Spearman's correlations and cross-tabulations. Discriminant validity to distinguish patients with active and non-active disease was assessed with receiver operating characteristic (ROC) curve analysis. For agreement analysis, kappa statistics were calculated.In testing for internal consistency, we found that Cronbach's alpha for the PRO-CLARA was 0.893, indicating high reliability. PRO-CLARA proved to be significantly correlated to established RA activity assessment tools. The area under ROC curve of the PRO-CLARA gives identical results to those provided by other comparator indices.The study showed satisfactory psychometric properties of the PRO-CLARA.

To retrospectively evaluate the role of the various imaging techniques in the study of the sternocostoclavicular joint, in patients with spondyloarthropathies and other rheumatic conditions and to assess potential pitfalls in the radiological diagnosis.Thirty patients, 11 male and 19 female, mean age 45 years, with involvement of the sternocostoclavicular joint as part of rheumatologic disorders (psoriatic arthritis, ankylosing spondylitis, Tietze syndrome, SAPHO syndrome, and condensing osteitis of the clavicle) were studied. Conventional radiography, CT, MRI and bone scintigraphy were performed. The following imaging findings were evaluated: soft tissue swelling, bone sclerosis, cortical bone erosions, joint space narrowing, subchondral sclerosis, periosteal new bone formation, synovial reaction and intrarticular effusion. All the images were independently reviewed by two musculoskeletal radiologists.Conventional radiography demonstrated only sclerosis of the clavicula in 8 pts (26%) and the sternum in 3 pts (10%), cortical bone erosions in 7 pts (23%), joint space narrowing in 6 pts (23%) and periosteal bone formation in 2 pts (10%). At the CT examination sclerosis of the clavicula and the sternum was observed in 13 pts (44%), cortical bone erosions in 22 pts (76%), joint space narrowing in 10 pts (34%), ligament ossification in 12 pts (41%), subchondral sclerosis in 9 pts (34%) and periosteal bone formation in 10 pts (34%). The MRI was the most sensitive technique in the evaluation of the soft tissue swelling in 9 pts (56%), intrarticular effusion in 13 pts (81%) and synovial reaction in 13 pts (81%). Finally, bone scintigraphy showed an increased uptake at the sterno-costoclavicular joint in all patients who underwent the examination.The radiological evaluation of the anterior chest wall in patients with different rheumatic disorders represents a problem of difficult diagnostic evaluation both for the anatomic region complexity and for the variability of the radiographic findings. The integrated use of X-ray, CT, MRI and nuclear medicine is suggested to avoid misdiagnosis.

To investigate the acceptability, feasibility, reliability and score agreement of collecting rheumatoid arthritis (RA) patient-reported outcome (PRO) data using an interactive touch-screen computer system.Eighty-seven RA patients completed both the touch-screen and conventional paper-administered set of questionnaires. For this purpose, we have developed a computerized touch-screen system, namely RHEUMATISM (RHEUMA Touch-screen Italian SysteM), to capture PRO data. Variables recorded include the following information: demographic data, VAS scores for pain, patient's and physician's assessment of global activity, and physician's assessment of general health status, 28-joint counts measuring tender and swollen joint, patient self-reported tender joint count, Recent-Onset Arthritis Disability index, and laboratory findings. In a further test-retest study, 35 patients were evaluated.Although over half the patients had no prior computer experience, nearly all found the touch-screen easy to use. Moreover, 86% of the patients preferred the computer format to the paper format (2%) and 12% of subjects had no preference. The quality of the data collected with the touch-screen system was good, with no missed responses. Agreement between scores obtained with the two modes of administration was very good, with concordance correlation coefficients (CCCs) from 0.887 to 0.972. CCCs were similar in men and in women, in subjects with or without prior computer experience and in subjects below or above age 65. The electronic questionnaire had good test-retest reliability (CCCs from 0.836 to 0.907).Computer touch-screen questionnaires were well accepted by RA patients, with good data quality, reliability and score agreement.

To investigate the association between articular chondrocalcinosis and calcification of the atlantoaxial region on a cervical computed tomography (CT) scan and to explore the relation between such calcifications and neck pain.CT slices of the cervico-occipital junction were performed routinely in 49 consecutive patients (male/female ratio 28/21; mean age 70.4 yrs), diagnosed with calcium pyrophosphate dihydrate crystal deposition disease (CPPD). Of these, 35 met criteria for definite CPPD and 14 met the criteria for probable. The cervical CT scans were analyzed for the presence of periodontoid calcifications by 2 independent musculoskeletal radiologists. Both assessors were blinded to the disease status of the patients. Furthermore, conventional radiographs of the upper cervical spine were performed. An ad hoc designed protocol was used to register information at diagnosis, including age, sex, location of pain and stiffness, fever, presence of synovitis and its location.CT scan of the cervico-occipital junction showed periodontoid calcified deposits in 25 out of 49 patients (51%) with CPPD. In 10 of the 25 cases (40%) with periodontoid calcified deposits, CT scanning showed osseous abnormalities of the odontoid process, such as subchondral cysts or erosions. Conventional radiographs showed calcification behind the odontoid process in 17 patients (34.7%). Nine of CPPD cases (18.4%) presented with neck symptoms. In three patients, articular chondrocalcinosis was revealed only by an acute attack of neck pain with segmentary stiffness, fever, and an increased erythrocyte sedimentation rate; in one of them initial clinical examination found cervical stiffness with Kernig's and/or Brudzinski's sign. For the other two patients, impairment of general condition, occipito-temporal and mandible pain and weakness with inflammatory pain of the shoulder girdle was suggestive of giant cell arteritis (GCA) and/or polymyalgia rheumatica (PMR). In the six additional patients, questioning elicited a history of previous subacute or chronic neck pain, from one week to one year before their admission to our ambulatory or hospital.These results suggest that CPPD deposition disease frequently involves the cervical spine. Although such calcification often remains asymptomatic, it may be associated with attacks of acute neck pain with segmentary stiffness, fever, and an increased erythrocyte sedimentation rate, sometimes mimicking PMR and/or GCA or neurological symptoms.

To investigate the reliability and validity of the Italian version of ECOS-16 (Assessment of health related quality of life in osteoporosis) in comparison to other questionnaires in postmenopausal women with osteoporosis.A cross-sectional multicentre study was carried out among postmenopausal women with osteoporosis who were attending primary care centres and hospital outpatient clinics. The patient group included 234 females (mean age 69 years, range 48-89) who presented vertebral fractures due to osteoporosis. The control group consisted of 244 asymptomatic osteoporotic subjects matched for age with the patient group. The psychometric properties of the questionnaires were evaluated in terms of feasibility, validity (construct validity and discriminant validity) and internal consistency. Test-retest reliability was analysed for 196 outpatients who reported that their general health status due to osteoporosis had not changed after one week. In all patients the ECOS-16, the SF-36 (Medical Outcomes Study Short Form-36), EUROQoL (EQ-5D), mini-OQLQ (mini-Osteoporosis Quality of Life Questionnaire), and RMDQ (Roland-Morris Disability Questionnaire) were administered, and all clinical variables and sociodemographic variables were taken into account. Construct and discriminant validity were assessed by Spearman's correlations, the Wilcoxon rank sum test, the Kruskal Wallis test and by receiver operating characteristic (ROC) curves. Internal consistency was evaluated using Cronbach's alpha and the test-retest reliability was evaluated by intra-class correlation coefficients (ICCs).96.9% of the patients answered all items of the ECOS-16 questionnaires. The mean administration time was 10 minutes. Factor analysis yielded two factors that accounted for 88.4% of the explained variance in the ECOS-16 questionnaire. The first factor was the ECOS-16 Physical Component Score (PCS) (45.9% of the explained variance) and the second factor was the ECOS-16 Mental Component Score (MCS) (42.4% of the explained variance). The inter-item correlation between the two factors was 0.48. Significant correlations were found between the scores of similar domains or subscales of the ECOS-16 and SF-36, EQ-5D and mini-OQLQ, supporting the concept of convergent construct validity. The total ECOS-16 score progressively increased with the number of prevelant vertebral fractures (p0.001) and the effect of the first fracture was already statistically significant (p0.01). On ROC curve analysis the total ECOS-16 score showed the highest performance among the different questionnaires in discriminating between patients with vertebral fractures and controls with no fractures. In the reliability study, internal consistency within the domain of ECOS-16 was generally good, with Chronbach's alpha values ranging from 0.81 to 0.89. Test-retest reliability was 0.87 for the total ECOS-16 score.The Italian version of the ECOS-16 questionnaire was demonstrated to have good psychometric properties and could offer a useful tool in research and routine clinical practice to evaluate HRQoL in post-menopausal women with osteoporosis. A full validation of the psychometric properties will require data on its sensitivity to change.

The main objective of the present study was to test the interobserver reliability, truth, discrimination and feasibility of two scoring methods available in ankylosing spondylitis (AS) over a follow-up period of 3 years.Two blinded trained observers scored 95 AS radiographs from a cohort of AS patients. Each radiograph was scored by two scoring methods, the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS), and the Bath Ankylosing Spondylitis Radiology Index--spine (BASRI-spine). Interobserver agreement was analyzed by intraclass correlation coefficients (ICC). The construct validity was assessed by examining the correlation of the scoring methods with measures of spinal mobility (Bath Ankylosing Spondylitis Metronomy Index--BASMI), functional limitation (Bath Ankylosing Spondylitis Functional Index--BASFI) and disease duration. Bland and Altman's 95% limits of agreement method and effect size (ES) analysis were used to estimate the smallest detectable difference (SDD) of radiological progression and responsiveness.The BASRI-spine reached intra- and interobserver ICC of 0.755 and 0.831, respectively. The mSASSS scores were more reliable, with ICC of 0.874 and 0.941, respectively. Both scoring systems correlated significantly with BASMI (p = 0.01), while only the mSASSS showed a significant correlation (p = 0.02) with BASFI. With regards to sensitivity to change, it was found that mSASSS classified the highest percentage of patients with more changes than the BASRI-spine (mSASSS: 35.8% vs. BASRI-spine: 15.8%). The ES analysis also suggested that the mSASSS was more responsive than BASRI-spine. Concerning feasibility, the BASRI-spine takes less time for scoring.We have shown that the mSASSS offers advantages in measurement properties and is the most appropriate method by which to assess progression of structural damage in AS.

The respiratory system may be involved in all systemic vasculitides (SV), although with a variable frequency. Lung disease is a very common and important feature of the antineutrophil cytoplasmic antibodies (ANCA)-associated SV (AASV), such as Wegener's granulomatosis (WG), Churg-Strauss syndrome (CSS), and microscopic polyangiitis (MPA). In WG, almost all patients have either upper airway or lower respiratory tract disease. Solitary or multiple nodules and masses are the most common findings on chest radiograph. Asthma is a cardinal symptom of CSS, often preceded by allergic rhinitis, frequently complicated by nasal polyposis and sinusitis. Pulmonary transient and patchy alveolar infiltrates are the most common radiographic findings. In MPA, diffuse alveolar hemorrhage (DAH) due to alveolar capillaritis is the most frequent manifestation of the respiratory involvement, clinically expressing with hemoptysis, respiratory distress and anemia. However, DAH may be subclinical and has to be suspected when chest radiograph demonstrates new unexplained bilateral alveolar infiltrates, in the face of falling hemoglobin levels. In giant cell arteritis, the most frequent respiratory symptom is cough, usually non-productive, persistent, and responsive to corticosteroids. In Takayasu arteritis, pulmonary involvement is frequently subclinical and detectable by non-invasive techniques. Pulmonary involvement is rare in polyarteritis nodosa, Kawasaki disease, Henoch-Schönlein purpura and cryoglobulinemic vasculitis. In conclusion, the involvement of the respiratory system is a very common and important feature of AASV, whereas is less frequent in other SV. It comprises a wide spectrum of clinical features and radiological findings, and may have a prognostic significance. The assessment of the respiratory system should be included in the work-up of all patients with SV, especially of those with AASV.

Musculoskeletal conditions are a major burden on individuals, health systems, and social care systems. The objective of the MAPPING study was to assess the impact of musculoskeletal conditions on health-related quality of life (HRQL) in an Italian population sample.Trained rheumatologists carried out structured visits in which subjects were asked about musculoskeletal symptoms and socio-demographic characteristics, completed validated instruments for measuring HRQL, such as the Short Form 36 items status survey questionnaire (SF-36), the EUROQoL five item questionnaire (EQ-5D), and chronic pain severity (Chronic Pain Grade - CPG questionnaire), and underwent a standardized physical examination. We considered a sample size of 576 patients diagnosed as having had musculoskeletal conditions. For the purposes of this study, musculoskeletal diseases were classified into 4 diagnostic groups: inflammatory rheumatic diseases (IRD), symptomatic peripheral osteoarthritis (SPOA), low back pain (LBP), and soft tissue disorders (STD). Cases were defined by previously validated criteria.The 4 major musculoskeletal disease groups, compared to non-sufferers, significantly impaired all eight health concepts of the SF-36 in the following order of magnitude: IRD, SPOA, STD, and LBP. Similar results were found for EQ-5D. The most striking impact was seen for SF-36 physical measures. On multiple regression modelling the physical component (PCS) of the SF-36 was influenced by female sex, age, high BMI, and low educational level (all at a p level0.001), and by manual occupation (p = 0.028) and chronic co-morbidity (p = 0.035) in LBP In SPOA, factors influencing physical function were age (p = 0.0001), low educational level (p = 0.006), female sex (p = 0.028), and chronic co-morbidity (p = 0.037). Moreover, an association on chronic co-morbidity and low educational level (both at a p level0.001), age (p = 0.004), and manual occupation (p = 0.035) was found with IRD, as well as of chronic co-morbidity and low educational level (both at a p level0.001), female sex (p = 0.006) and high BMI (p = 0.036) with STD were also found. Similar results were found for EQ-5D.The MAPPING study indicates that musculoskeletal conditions have a clearly detrimental effect on the HRQL and one third of the adult population in Italy visited at least one physician for musculoskeletal problem in the past year. These results enable a comparison to be made of the burden of musculoskeletal conditions with that of other common chronic conditions.

Disability has been identified as a core outcome measure in rheumatoid arthritis (RA). The aim of this study was to test the Recent-Onset Arthritis Disability (ROAD) questionnaire for validity, reliability and responsiveness in Italian patients with early RA.The psychometric properties of ROAD were tested in 159 patients with early RA, mean age 54.7 (+/- 8.8), 74.3% women, mean disease duration 14.5 months (+/- 1.9 months). All completed the ROAD, the Medical Outcomes Study SF-36 Health Survey (SF-36), the Health Assessment Questionnaire (HAQ) and the patient global assessment (PGA) of functional disability twice, in order to test for validity and responsiveness. Of the 159 patients who completed the health status instruments on two occasions, 121 were included in the responsiveness analyses. The test-retest reliability of the ROAD questionnaire was calculated using intraclass correlation coefficients (ICCs) and the Bland and Altman method on 77 patients who completed the questionnaire twice over an interval of one week. Construct validity was assessed using Spearman's correlations, while responsiveness was evaluated by 3 different methods: (1) effect size (the mean difference between the baseline scores and thefollow-up scores divided by the standard deviation of the baseline scores); (2) standardized response mean (the mean change in scores divided by the standard deviation of the change in scores); (3) receiver operating characteristics (ROC) curve analysis.ROAD fulfilled the established criteria for validity, reliability and responsiveness. In comparison with the SF-36, the expected correlations were found when comparing items measuring similar constructs, thus supporting the convergent construct validity. Significant correlations were seen between ROAD scores and HAQ scores (rho = 0.372), SF-36 physical component summary (PCS) (rho = -0.413), PGA functional disability (rho = 0.417), pain (rho = 0.639), Ritchie index (rho = 0.357), number of swollen joints (rho = 0.387), patient and physician assessment of disease activity (rho = 0.467 and 0.323, respectively), and Disease Activity Score (rho = 0.476). Test-retest reliability was satisfactory, with ICCs of 0.927 (upper extremity function), 0.892 (lower extremity function), and 0.851 (activity of daily living/work). Bland-Altman plots confirmed this finding. The results of responsiveness analysis indicate that the ROAD subscales were slightly more sensitive to perceived change in functional disability than those of HAQ, SF-36 PCS, and PGA offunctional disability.Our data suggest that the ROAD index is a reliable, valid and responsive tool for measuring physical functioning in patients with early RA, and is suitable for use in clinical trials and daily clinical practice. Its generalizability and utility for assessing aggressive treatment and functional outcomes must now be evaluated in broader settings.

To develop a self-administered questionnaire, the ROAD (Recent-Onset Arthritis Disability), to probe physical disability in Italian patients with early arthritis (EA) of less than one year's duration.The development of the ROAD follows a series of major steps: (1) identification of a specific patient population, (2) item pool development, (3) item reduction, (4) internal consistency, (5) pre-testing of the prototype instrument, and (6) a validation study which results in determination, reliability, validity and responsiveness. In this study we have verified the first five steps. Pre-defined areas of disability were culled from eight existing Italian version arthritis-specific questionnaires, and three generic global health measurement tools. Semi-structured interviews helped to derive a 76-item pool from an initial group of 122 items. This questionnaire was administered to 78 EA patients.For scale generation, a combination of frequency importance product (FIP = frequency x mean relevance score) and factor analysis was applied. The top 20 items based on the FIP were then subjected to further analysis. Each question was correlated with every other question. This allowed us to eliminate 8 questions that were therefore highly correlated and were measuring the same concept. The final instrument has 12 items, representing a combination of symptoms that are common, frequently recurring and of general importance to EA patients. Factor analysis provides a 3-factor health status model explaining 70.1% of the variance. The upper extremity function (5 items) is loaded on the first factor, which explains 45.4% of the total measured variance. The lower extremity function (4 items) formed the second factor (14.2% of the total variance). The third factor was determined by activities of daily living/work (3 items) and explain 10.5% of the total variance. The score of the different subscales can be presented graphically as a ROAD profile.Using a traditional development strategy, we have constructed a self-administered instrument for measuring physical functioning in patients with EA. The next stage includes reliability, validity and responsiveness testing of the 12-item questionnaire.

Rheumatic diseases have an economic impact of 1-2.5% of GDP in industrialized countries and osteoarthritis is the most common joint disorder. Osteoarthritis of the knee is especially common and is a major cause of disability requiring extensive utilization of health care resources.To estimate the burden of osteoarthritis of the knee in Italy, we studied retrospectively a cohort of 254 patients over a period of 12 months in 2000-2001.Twenty-nine rheumatology institutes took part in the study. A bottom-up approach was used, analytically measuring pro capita consumption. We considered medical (hospitalization, diagnosis, and therapies) and non-medical costs (transport, temporary caregivers, and auxiliary devices) as direct costs. We calculated losses of productivity borne by patients and caregivers, and informal care provided by caregivers as indirect costs.Direct costs came to Euros 934 per patient per year: Euros 233 were spent on hospitalization, Euros 209 on diagnostic procedures (56% on visits and 44% on instrumental and laboratory tests), Euros 146 on therapy (58% on physiotherapy and 42% on drugs), and Euros 346 on non-medical costs (73% on salaries to temporary caregivers, 14% on transport, and 13% on auxiliary devices). It is interesting to point out that at least 37% of costs were charged directly to patients. Indirect costs were almost 30% higher and came to Euros 1236 per patient per year: 31% was due to loss of productivity of patients, 60% due to informal care provided by primary caregivers, and 9% by other caregivers.This study confirms that the direct and indirect costs attributable to osteoarthritis of the knee are substantial.

Rheumatoid arthritis (RA) is a chronic and disabling disease frequently leading to physical and psychological dependence, with considerable economic consequences. The aim of our study was to perform a cost-of-illness analysis for RA according to the four different levels of functional RA severity.Direct costs (hospitalisations, treatments, diagnostics and the non-medical costs), indirect costs (productivity losses and informal care), and intangible costs (deterioration in the quality of life of patients, their families and friends assessed by the Medical Outcome Survey Short Form and the Stanford Health Assessment Questionnaire) were measured in 200 RA patients.The social costs--direct plus indirect costs--increased as RA worsened. The direct costs increase very significantly (p0.0005) among the four functional classes (respectively Euro 1643.4 - 2910.2 - 4236.5 - 5696.8), likewise the indirect costs (respectively Euro 2704.9 - 9566.4 - 12183.1 - 17249.2). Moreover social costs, analysed independently from the functional classes, are significantly higher in patients with other concomitant diseases. As far as the intangible costs are concerned, for all the areas explored by the scales used, the high impact of RA on the quality of life of RA patients was markedly evident. Female gender and co-morbidity are associated with higher costs.In Italy, the indirect costs account for the highest cost for management of RA patients. Considering that costs increase with RA progression, the patients who show a rapid evolution of the functional damages should be identified early based on risk indicators.

The effect of recombinant interferon alpha-2 (IFN alpha 2) therapy in Sjögren's syndrome (SS) was studied.An open study was performed in which 20 SS patients were given IFN alpha 2 3.10(6) MU/3 times/week or OH-chloroquine (OH-C) 6 mg/kg/daily, for a mean period of 11 months.Gland assessment showed that lacrimal and salivary function improved by 67% and 61% versus 15% and 18% respectively (p0.01) in the patients treated with IFN alpha 2 compared to those treated with OH-C. Immunological parameters did not change over time in either group. In 3 patients a decrease in the tissue score was observed in the IFN alpha 2 group, while no changes were seen in the control group. Tolerability was acceptable.This study shows that IFN can improve tear function and dry mouth in SS, without causing significant side effects.

To determine the long-term efficacy and safety of weekly low-dose methotrexate (MTX) in rheumatoid arthritis (RA).Fifty-one patients receiving MTX for RA were prospectively studied over a mean treatment period of 36 months. Standard clinical and laboratory measures of disease activity were assessed by the same investigator at baseline, and at 3, 6, 12, 24 and 36 months.The overall probability of continuing to take MTX was 80.3% at 12 months, 74.5% at 24 months, and 70.5% at 36 months. Of the 36 patients who completed 36 months of therapy, a significant improvement was noted compared to baseline in all of the clinical disease variables and acute phase reactants, with a steroid-sparing effect. There were no significant differences in these parameters between the 36-month visit and the 24- or 12-month visit. Adverse events occurred frequently (80.3%), but only 15.6% of the patients discontinued MTX permanently. Four patients (7.9%) withdrew due to a lack of efficacy.Our findings indicate that MTX remains effective over 36 months of therapy, with an acceptable toxicity profile.

Ninety-four rheumatoid patients were studied through laboratory, clinical, algometric, functional and psychological parameters (29 variables in all). Using factorial analysis, four factors emerged which explained 74% of the common variance. The four factors were: the disability factor (explaining 39% of the variance); the biology factor (explaining 21%); the algology factor (explaining 8%); and the clinical factor represented by the Ritchie Articular Index (RAI) (explaining 6%). The four items were used to construct a Chronic Arthritis Systemic Index (CASI) which correlated significantly with other indices, such as the Mallya-Mace, the Thompson and the limited Lansbury indices. CASI provided to be very useful in monitoring the disease course in a short term study of 22 patients undergoing DMARD treatment. Taking into account the parameters proposed as outcome measures by several workshops, CASI can monitor both the activity and severity of chronic arthritides through simple measures.

Forty-two consecutive female rheumatoid patients were given the AIMS questionnaire in order to determine their disability. Twenty-one had a second assessment one year later. Factorial analysis showed that the Italian version fully respects the construct of the original test. In fact four main factors (the physical, psychological, social and pain dimensions) arose, explaining 44.8%, 13.6%, 11.4% and 9% of the total variance, respectively. A close relationship was demonstrated between psychological variables, namely depression, and physical impairment, as shown by the correlation coefficient matrix. In order to determine whether depression might influence the ultimate outcome twenty-one patients were separated into two subsets according to their initial depression (greater than 5, less than 5). After one year, dexterity and pain were significantly worse in those with the highest depression score. This study shows that the psychological variables, in addition to physical impairment and pain, are of utmost importance in the outcome of rheumatoid patients.

Fifty-five patients, (30 Rheumatoid Arthritis (RA) and 25 Osteoarthritis (OA], with knee synovial effusion and popliteal cysts, visualized through arthrograms, were studied. A relationship was sought between radiological findings and area of the cysts, measured through a millimeter grid. Ten radiological parameters were graded and summed up to obtain a "total knee score". A "total geode score" was also obtained by scoring, separately, the geodes. In addition two specific indexes were used--for comparison--the erosive index, modified after Berens and Lin, in RA and the Kelligren's index in OA. In RA a statistically significant, inverse correlation was found between the x-ray scores and the area of the cysts, while such a relationship was not observed in OA. However, only a third of the cysts accounted for the inverse relationship in RA. Furthermore, two control groups of RA and OA patients revealed a striking association between degree of radiological damage and frequency of popliteal cysts. Therefore, the hypothesis that popliteal cysts might have a protective effect against the articular-bone damage in RA, can be held only in few cases.

The relationship between structural changes of the minor salivary glands with age was evaluated by morphometric analysis in twenty patients with primary Sjögren's syndrome (prim. SS) (Group I) and in twenty sex and age-matched normal subjects (Group II). No statistically significant differences were found in the acinar tissue, intralobular ducts (ILD) and fibrous tissue between the two Groups. In contrast, there was a 5-fold increase in the volume fraction of inflammatory cells in Group 1. In both Groups the percentage of fibrous tissue and ILD increases and the percentage of acinar tissue decreases linearly with age. In Group I the increase in the volume percentage of fibrous tissue and the decrease in the volume fraction of the acinar tissue were not related to the volume percentage of inflammatory cells. These results demonstrate that in prim. SS the acinar atrophy is not related to the inflammatory process but is an age-dependent phenomenon.

Two patients who developed thrombocytopenia while on Tiopronin and gold salts respectively were HLA typed. Their common haplotype was A25(10), B8, DR3. A survey of the literature showed that the association between DR3 and the sudden onset form of thrombocytopenia is striking. A genetic predisposition, besides other unknown factors, seems to play a crucial role.

Two hundred rheumatoid patients were prospectively studied over a five-year period. One hundred and three received tiopronin (T) and 97 were treated with gold thiosulphate (GTS). At the end of the five-year period, similar percentages of patients dropped out because of lack of efficacy or because of major toxicities. Likewise, the percentages of patients still receiving the original drug in the two drug regimens at the 5th year of follow-up were 27.8% (GTS) vs. 25.2% (T), respectively.