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Introduction: Interstitial lung disease in rheumatoid arthritis (RA-ILD) is an extra-articular involvement that impairs the prognosis and for which there is still no well-coded treatment. The aim of this study was to evaluate abatacept (ABA) effectiveness and safety in patients with RA-ILD., Methods: RA-ILD patients who started ABA treatment were consecutively enrolled. Chest high-resolution computed tomography (HRCT), clinical, laboratory and respiratory function variables were collected at baseline and after 18 months of ABA treatment. HRCT abnormalities were evaluated using a computer-aided method (CaM). ABA response was established based on the change in the percentage of fibrosis evaluated at HRCT-CaM, dividing patients into "worsened" (progression ≥ 15%), "improved" (reduction ≥ 15%), and "stable" (changes within the 15% range). The multivariate regression model was used to assess the associations between RA characteristics and ABA response., Results: Forty-four patients (81% women, mean age 59.1 ± 8.0, mean disease duration of 7.5 ± 3.1 years) were studied. Five patients (11.4%) showed RA-ILD progression, 32 patients (72.6%) were considered stable, and 7 patients (16.0%) showed an RA-ILD improvement. The proportion of current smokers was significantly different between "worsened" patients, respect to those defined as "improved/stable" (p = 0.01). Current smoking habit (p = 0.005) and concomitant methotrexate treatment (p = 0.0078) were the two variables related to RA-ILD progression in multivariate regression analysis., Conclusion: Treatment with ABA is associated with a RA-ILD stability or improvement in the 88.6% of patients. Current smoking habit and concomitant treatment with methotrexate are the modifiable factors associated with RA-ILD worsening. Key Points • Abatacept plays a favourable role in the control of RA-ILD, with a significant worsening in only 11.4% of patients during a 18-month follow-up period. • The predictive variables related to RA-ILD progression during abatacept therapy are the concomitant treatment with methotrexate and current smoking habit., (© 2021. The Author(s).)

Background: Frailty is a construct recently introduced in the context of inflammatory joint diseases. To date, it is not clear if frailty can act as a negative factor in the achievement of comprehensive disease control (CDC) in patients suffering from rheumatoid arthritis (RA)., Aim: To verify whether frailty is a factor hindering the achievement of CDC in patients with RA starting a biologic drug., Methods: RA patients requiring a treatment with a biologic drug were included. Patients were classified as achieving or not achieving CDC after 12 months of treatment. Patients were classified as non-frail, mildly frail, moderately frail and severely frail according to the Comprehensive Rheumatologic Assessment of Frailty (CRAF). Frailty was tested using the Mann-Whitney or Kruskal-Wallis test for continuous variables and chi-square test or Fisher's exact test for comparison with categorical variables. A multivariable logistic regression was performed to identify factors associated with prediction of CDC achievers., Results: A total of 214 RA patients were followed for 12 months, 14.5% achieved CDC. Eighty-four (39.3%) patients were non-frail, 57 (26.6%) were mildly frail, 14 (6.5%) were moderately frail and 59 (27.6%) were severely frail. The multivariable logistic regression analysis identified the CRAF score at baseline as an independent variable for CDC achievement at 12 months (p = 0.0040)., Discussion: Frailty is a frequent condition in RA patients and reduces the chances of achieving CDC., Conclusions: Frailty, measured by CRAF, reduced the likelihood of CDC achievement in RA patients treated with a biologic agent. Key Points • Frailty is an under-researched condition in rheumatoid arthritis affecting more than 60% of patients. • Frailty is a condition that hinders the achievement of comprehensive disease control after 1 year of treatment with biological drugs in patients with rheumatoid arthritis., (© 2021. The Author(s).)

Background: Frailty is a frequent condition in patients with knee osteoarthritis (KOA). However, there are different constructs on how to define it. Survey of Health, Ageing and Retirement in Europe-Frailty Instrument (SHARE-FI) is one of them., Aim: To assess the prevalence of frailty, according to the SHARE-FI definition in patients with symptomatic KOA, and to establish its associated factors., Methods: Symptomatic KOA patients were evaluated for pain symptoms, quality of life, comorbidities, ongoing drug therapy, and radiological damage. Patients were categorised according to the SHARE-FI definition into frail, pre-frail, and non-frail, and compared to a group of healthy controls associated by age and gender., Results: 170 symptomatic KOA patients (76.5% female, mean age 70.1 years) and 186 healthy controls were included. According to SHARE-FI criteria, 35 patients (20.6%) were categorised frail, 50 (29.4%) pre-frail, and 85 (50%) non-frail. The prevalence of frail or pre-frail subjects was statistically significantly higher in patients with symptomatic KOA. Stratifying the patients according to the frailty categories, frail subjects showed significantly higher mean values of pain. The results from logistic regression analysis revealed that polypharmacy (p = 0.003), pain (p = 0.016) and comorbidities (p = 0.035) were the variables independently associated with frailty in symptomatic KOA., Discussion: Frailty or pre-frailty, defined by SHARE-FI, is common in symptomatic KOA. The main factors associated with frailty were polypharmacy, pain and comorbidity burden., Conclusions: SHARE-FI can represent an useful tool to define frailty in symptomatic KOA.

Ultrasound (US) is a promising tool for assessing sarcopenia. We aimed to test in the rheumatology setting two US scanning protocols to measure muscle thickness (MT) at the anterior thigh level and to assess their feasibility and reliability. In the first phase of the study, three rheumatologists performed a US examination on 19 consecutive patients adopting two scanning protocols, namely the anterior superior iliac spine (ASIS) and the greater trochanter techniques. After consensus was obtained on the easiest scanning protocol to perform, two rheumatologists adopted only the ASIS technique in 40 consecutive patients. MT measurements were recorded as well as the time needed to complete each scanning protocol bilaterally. The median time needed to complete the US examination was under 5 minutes for each of the two techniques, with no significant difference between them (p = 0.64). In the first phase, we found an excellent inter-observer reliability of the proposed scanning protocols, with a higher but nonstatistically significant intraclass correlation coefficient (ICC) for the ASIS technique compared with the greater trochanter technique (ICC 0.97 vs. ICC 0.92, p = 0.05). The ASIS technique had a significantly higher intra-observer reliability (ICC 0.97 vs. ICC 0.92, p < 0.01). In the second phase, the ASIS technique confirmed on a larger sample its excellent inter-observer reliability, with an ICC of 0.96. The present study presents a novel tool for assessing sarcopenia and provides evidence in favor of feasibility and reliability of US measurement of MT at the anterior thigh level in rheumatology setting. Key Points • This study demonstrates that ultrasound (US) measurement of muscle thickness at the anterior thigh level is highly reliable, especially for the "anterior superior iliac spine (ASIS)" technique. • The short time needed to complete the US assessment highlights the feasibility of the proposed scanning protocols. • The simplicity and conciseness of the proposed techniques will allow other researchers and clinicians to use it for a fast assessment of sarcopenia.

Objectives: The aims of the present research were to assess the prevalence of frailty and its potential associated factors in a cohort of adult patients with rheumatoid arthritis (RA)., Methods: Consecutive RA patients and healthy controls were assessed according to the Survey of Health, Ageing and Retirement in Europe Frailty Instrument (SHARE-FI), and classified as frail, pre-frail, or non-frail. Chi-square, analysis of variance (ANOVA), and multinomial logistic regression analyses were used to test the prognostic value of frailty for the outcomes of interest., Results: Two hundred and ten consecutive RA patients (65.7% female, mean age 60.4 years) and 100 healthy controls (63% female, mean age 59.1 years) were included. According to SHARE-FI criteria, 35 RA patients (16.6%) were categorized as frail, 68 (32.4%) as pre-frail, and 107 (51%) as non-frail, while 8 control subjects were categorized as frail, (8%), 17 as pre-frail (17%), and 75 as non-frail (75%) (chi-squared 12.8; P = 0.0016). The results from logistic regression analysis revealed that age (odds ratio [OR] = 1.12, 95% confidence interval [CI] = 1.07-1.17; P < 0.0001), comorbidities (OR = 1.51, 95% CI = 1.01-2.27; P = 0.0446), and high disease activity (OR = 1.10, 95% CI = 1.04-1.16; P = 0.0006) were independently associated with frailty in RA., Conclusions: Frailty or pre-frailty are common in RA. The SHARE-FI may be a useful tool for the screening of frailty in RA and may summarize the results of a comprehensive RA assessment providing a marker of deficits accumulation.

Psoriatic arthritis (PsA) is a chronic inflammatory autoimmune arthritis, occurring in patients with psoriasis (Pso), that may affect the whole musculoskeletal system but also nails, eye, and gastrointestinal tract. Dermatologists and rheumatologists usually manage Pso and PsA separately, but early diagnosis and integrated management could achieve better outcomes of both skin and musculoskeletal manifestations, thus improving the health-related quality of life (HRQoL) of patients. In this work, we have described a model of integrated dermo-rheumatologic approach for the early diagnosis of PsA and to present the outcomes of the multidisciplinary management of PsA patients after 48 weeks of follow-up. Pso patients complaining musculoskeletal symptoms were enrolled in a DErmo-Rheumatologic Clinic (DERC) in order to screen, classify, and treat patients with PsA, employing an operative working procedure and a specific flowchart. The integrated dermatologic and rheumatologic management of PsA patients allowed a prompt establishment of the diagnosis and the best therapeutic approach in these patients, with a significant improvement of skin and articular diseases and, eventually, a consistent amelioration of HRQoL. Dermatologists and rheumatologists usually manage the "psoriatic disease" in separated outpatient clinics. In our study, we have demonstrated that a combined DERC, by means of a tight cooperation between the dermatologist and the rheumatologist, which use a specific working procedure and treatment flowchart, may achieve the optimal clinical management of these patients, with a consistent clinical remission of the disease and a significant amelioration of the HRQoL.

To develop and to test in a preliminary way a new self-administered screening tool, called DETection of Arthritis in Inflammatory boweL diseases (DETAIL) questionnaire, in patients suffering from inflammatory bowel disease (IBD) not previously diagnosed as having a spondyloarthritis (SpA). DETAIL questionnaire was realized through the interrogation of 95 experts. They were asked to rate the importance of a list of items, derived from a review of the referral models of SpA, to detect the SpA manifestations in IBD patients. The six top-rated items composed the questionnaire, tested in IBD patients not already diagnosed having a SpA. One-hundred and twenty-eight patients were tested with the DETAIL questionnaire in the gastroenterology setting. After the rheumatologic assessment, in 21 (16.4%) subjects was diagnosed a SpA according to the Assessment of SpondyloArthritis international Society (ASAS) classification criteria. Of the six items of the DETAIL questionnaire, the best positive likelihood ratio (LR+) was found in item 2 (LR+ 3.82), exploring dactylitis, and in item 6 (LR+ 3.82) and item 5 (LR+ 3.40), two questions exploring inflammatory low back pain. Enthesitis (item 3-LR+ 2.87) and peripheral synovitis (item 1 - LR+ 2.81) gave similar results, while item 4, exploring the duration of low back pain, resulted in the worst performance (LR+ 1.99). Three of the six items answered in affirmative way gave a post-test probability ≥ 75%. The presence of a fibromyalgia represents a major confounder. The DETAIL questionnaire showed good screening properties that need to be confirmed in broader cohorts.

The purpose of the study was to estimate the clinical profile of naïve biological patients with rheumatoid arthritis (RA) starting adalimumab through 3-year calendar periods and their clinical outcomes such as drug survival and global clinical disease control (GCDC). RA patients starting adalimumab as first biological drug between 2003 and 2012 were subdivided in 3-year calendar periods. Survival on therapy was estimated using the Kaplan-Meier analysis. One and 2-year clinical response was assessed by calculating percentage of patients attaining GCDC (28-joint Disease Activity Score (DAS28) ≤ 2.6 + Health Assessment Questionnaire (HAQ) ≤ 0.5), low disease activity (DAS28 ≤ 3.2), remission (DAS28 ≤ 2.6) and good European League Against Rheumatism (EULAR) response. Multivariate regression models were used to assess baseline predictors of drug discontinuation or achievement of clinical remission. We recruited 1695 RA patients. Overall drug persistence at 3 years was 40.6 %, while the global rate of nonswitching patients was 54.7 %. Compared to 2003-2005, initiators in more recent years had a significantly lower 3-year crude drug retention rate (log rank, p < 0.0001) and a significantly higher rate of switching to alternative biologics (log rank, p < 0.0001). No difference in adverse events or effectiveness rate among the calendar periods was found. A substantial proportion of patients (up to 27 %) achieved GCDC at 2 years, regardless of the calendar period. In real-life setting, RA patients starting adalimumab in more recent years had a higher rate of drug discontinuation not related to ineffectiveness or side effects but to switching, probably due to a wider availability of biologics. A meaningful proportion of patients attained GCDC without any difference across calendar periods.

The aim of this study is to investigate the prevalence of subclinical ankle involvement by ultrasound in patients with rheumatoid arthritis (RA). The study was conducted on 216 patients with RA and 200 healthy sex- and age-matched controls. Patients with no history or clinical evidence of ankle involvement underwent US examination. For each ankle, tibio-talar (TT) joint, tibialis anterior (TA) tendon, extensor halux (EH) and extensor common (EC) tendons, tibialis posterior (TP) tendon, flexor common (FC) tendon and flexor hallux (FH) tendon, peroneous brevis (PB) and longus (PL) tendons, Achilles tendon (AT) and plantar fascia (PF) were assessed. The following abnormalities were recorded: synovitis, tenosynovitis, bursitis, enthesopathy and rupture. BMI, DAS28, RF ESR and CRP were also obtained. A total of 432 ankles of patients with RA and 400 ankles of healthy controls were assessed. In 188 (87%) patients with RA, US showed ankle abnormalities whereas, in control group, US found abnormalities in 57 (28.5 %) subjects (p = 0.01). The most frequent US abnormality in RA patients was TP tenosynovits (69/216) (31.9 %), followed by PL tenosynovitis (58/216) (26.9 %), TT synovitis (54/216) (25 %), PB tenosynovitis (51/216) (23.6 %), AT enthesopathy (41/216) (19 %) and AT bursitis (22/216) (10.2 %). In 118 RA patients out of 216 (54.6%), a positive PD was found. No statistically significant correlation was found between the US findings and age, disease duration, BMI, DAS28, RF, ESR and CRP. The present study provides evidence of the higher prevalence of subclinical ankle involvement in RA patients than in age- and gender-matched healthy controls identified by US.

Ultrasound (US) is increasing its potential in the assessment of several rheumatic disorders. Recently, different applications of this imaging technique have emerged. Interesting data supporting its utility and validity in the assessment of the lung to detect and quantify interstitial pulmonary fibrosis in rheumatic diseases, even in subclinical phases, have been reported. The main purpose of this review is to provide an overview of the role of US in the assessment of interstitial pulmonary fibrosis in rheumatic disorders and to discuss the current evidence supporting its clinical relevance in daily clinical practice.

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).

Over the last decade, a growing number of studies have been published supporting the high prevalence of atherosclerosis in rheumatic patients with chronic inflammatory diseases. Ultrasound (US) represents the imaging technique of choice for revealing early atherosclerotic changes at carotids level. New US software, mainly developed to rectify its operator dependence, requires a comparison with conventional technique. The main aim of the present study was to compare conventional and software-guided US in the assessment of intima-media thickness (IMT) of common carotids. Thirty-two consecutive patients with chronic inflammatory rheumatic conditions, presenting at the outpatient clinics of the Rheumatology Department--Università Politecnica delle Marche, Italy--were enrolled in the present study. The patients underwent a US assessment of the IMT of the posterior wall of common carotids using a My Lab 70 XVG system (Esaote SpA, Genoa, Italy) equipped with a 4-13 MHz linear probe. The US examinations were performed by two sonographers. One of them used the conventional manual approach and the second sonographer adopted a software-guided technique (named RF-QIMT technology). Inter-observer reliability was determined using intra-class correlation coefficient (ICC) and the Bland-Altman plot. Agreement between the two methods was high with ICC value of 0.74 (0.69 and 0.77 for the right and left common carotid, respectively). The Bland-Altman plot showed minimal proportional error and high limits of agreement. Substantial inter-observer agreement rates for the assessment of the IMT were achieved. Further studies are encouraged to confirm these results in a larger cohort of patients.

This study was conducted to determine the prevalence of subclinical entheseal involvement at the greater trochanter level by ultrasound in patients with spondyloarthritis. Forty-six patients with spondyloarthritis and 46 healthy age- and sex-matched controls were studied. All patients with no clinical evidence of enthesopathy at the greater trochanter underwent an ultrasound examination. The following three entheses were scanned bilaterally: anterior insertion of gluteus minimus, anterior insertion of gluteus medius, and posterior insertion of gluteus medius. Ultrasound findings of enthesopathy were thickening, calcifications, bone erosions, enthesophytes, bursitis, and power Doppler signal. A total of 276 entheses were evaluated in spondyloarthritis patients. In 112 out of 276 (40.5%), grayscale ultrasound found enthesopathy. The enthesis with the highest number of signs of enthesopathy was the anterior insertion of gluteus medius (46/276) (16%), followed by posterior insertion of gluteus medius (37/276) (13.4%) and anterior insertion of gluteus minimus (29/276) (10.5%). In the healthy population, ultrasound found entesopathy in 80 out of 276 (29%) entheseal sites (p < 0.0001). Posterior insertion of gluteus medius enthesis was the more frequently involved (34/276) (12.3%), followed by anterior insertion of gluteus medius (24/276) (8.6%) and anterior insertion of gluteus minimus (22/276) (7.9%). Power Doppler was found more frequently in patients with spondyloarthritis compared with healthy controls (1% vs 0%). Our results show a higher prevalence of subclinical enthesopathy at the greater trochanter level in patients with spondyloarthritis than in age- and sex-matched healthy controls.

The aim of this study is to perform a psychometric analysis of the Lequesne Algofunctional Indexes (LAI) for the severity of osteoarthritis (OA) of the hip (LAI-hip) and knee (LAI-knee), using classical test theory (CTT) and Rasch analysis. Questionnaires were completed by 1,214 patients with symptomatic OA of the knee (n = 697) and hip (n = 517). Internal consistency was evaluated using Cronbach's alpha and an item-to-total correlation. Dimensionality was investigated with a factor analysis. Raw scores underwent Rasch analysis. Cronbach's alpha was 0.84 for LAI-hip and 0.82 for LAI-knee. LAI-hip resulted in unidimensionality according to the factor analysis, while LAI-knee supported both a single and a two-factor solution (items 1-6b and 7-10, respectively). At Rasch analysis, the rating categories of item 'maximum distance walked' did not comply with the criteria for category functioning in either LAI-hip or LAI-knee. A test of the residual correlation showed item dependency in both LAI-hip and LAI-knee. Misfitting items were present in both the scales. According to both CTT and Rasch analysis, in our two samples representing a wide spectrum of both hip and knee OA severity the LAI-hip and LAI-knee showed a series of drawbacks, which rendered both questionnaires inadequate in relation to their metric properties and severely limit their ability to perform, as a composite measure, in line with the main aims of their developers.

Long-term dialysis treatment can be associated with several musculoskeletal complications. Entheseal involvement in dialysis patients remains rarely studied as its prevalence is underestimated due to its often asymptomatic presentation. The aims of the study were to determine the prevalence of subclinical enthesopathy in haemodialysis and peritoneal dialysis patients at the lower limb level, to investigate the inter-observer reliability of ultrasound assessment and to analyse the influence of biometric and biochemical parameters. Ultrasound examination was conducted at the entheses of the lower limbs level in 33 asymptomatic dialysis patients and 33 healthy adopting the Glasgow Ultrasound Enthesitis Scoring System (GUESS). The inter-observer reliability was calculated in 15 dialysis patients. Ultrasound found at least one sign of enthesopathy in 165 out of 330 (50%) entheses of dialysis patients. In healthy subjects, signs of enthesopathy were present in 54 out of 330 (16.3%) entheses (p < 0.0001). No power Doppler signal was detected in healthy controls, in contrast to four of 330 entheses of dialysis patients. No US signs of soft tissue amyloid deposits were found. The GUESS score was significantly higher in dialysis patients than in controls (p < 0.0001). There was no difference in terms of enthesopathy between haemodialysis and peritoneal dialysis. Dialysis duration resulted to be the most important predictor for enthesopathy (p = 0.0004), followed by patient age (p = 0.02) and body mass index (p = 0.035). Parathormone, calcium, phosphorus, C-reactive protein, cholesterol and triglycerides apparently did not play a relevant role in favour of enthesopathy. The inter-observer reliability showed an excellent agreement between sonographers with different degree of experience. Our results demonstrated a higher prevalence of subclinical enthesopathy in both haemodialysis and peritoneal dialysis patients than in healthy subjects. Follow-up will provide further information with respect to the predictive value of US findings for the development of symptomatic dialysis-related arthropathy.

Involvement of the sacroiliac joints is the first predominant finding of all seronegative spondylarthropathies (SpA) subsets, such as ankylosing spondylitis, psoriatic arthritis, and undifferentiated SpA. Although conventional radiography is indicated in the initial evaluation of sacroiliac joints diseases, it is often insensitive for demonstrating the early changes of sacroiliitis, so other imaging techniques typically are often necessary to clarify the pathology and for establishing the early diagnosis of seronegative SpA. Other imaging modalities, including computed tomography (CT), magnetic resonance imaging (MRI), ultrasonography (US), and bone scintigraphy have improved visualization of inflammatory changes at the sacroiliac joints (SIJ). CT scans are indicated for disease processes in which bony destruction or ossification may occur. MRI has been proposed as an imaging method to detect sacroiliitis earlier. MRI can identify both inflammation and structural changes caused by inflammation, while radiographs show only structural changes. MRI may be particularly useful in making a diagnosis of SpA. Musculoskeletal US has an increasing and relevant role in the evaluation of SpA mainly for its ability to assess joint and periarticular soft tissue involvement and in particular for its capacity to detect enthesitis. US assessment in general is safe, noninvasive, and comparably cheap, showing itself as a complimentary tool to clinical evaluation in SpA; nevertheless, it is very user dependent. Bone scintigraphy is at most of limited diagnostic value for the diagnosis of established AS, including the early diagnosis of probable/suspected sacroiliitis. The main aim of this study is to introduce the clinical and radiological aspects of the SIJ involvement in SpA, particularly the contribution of the different imaging techniques.

The sternocostoclavicular (SCC) region is subject to the same diseases that occur in joints, with congenital and developmental anomalies, inflammatory and infectious diseases, soft tissue and bone tumors as well as the seronegative spondyloarthropathies, including ankylosing spondylitis, reactive arthritis, enteropathic arthritis, psoriatic arthritis, pustulosis palmoplantaris and other syndromes. Most of these conditions present with swelling of the joint, which may be associated with pain and/or tenderness. These disorders are characterised by onset usually before the age of 40 years, absence of serum autoantibodies and sometimes the association with antigen human leukocyte antigen B27. Traditional X-ray study is indicated in the initial evaluation of SCC joint disorders, but other imaging modalities typically are often necessary to clarify the pathology. Computed axial tomography scans are indicated for disease processes in which bony destruction or ossification may occur. Magnetic resonance imaging provides more detailed and useful information when evaluating suspected pathology involving inflammation or soft tissue mass. Bone scintigraphy can help to correlate active inflammation of the SCC joint with symptoms of pain. The purpose of this study is to introduce the clinical and radiological aspects of the seronegative anterior chest wall diseases, particularly the contribution of the different imaging techniques.

The aim of this study is to analyse the psychometric properties of the Italian version of the Chronic Pain Grade (CPG) questionnaire within a population of chronic musculoskeletal pain patients. The CPG questionnaire was adapted following the translation and back-translation methodologies. There were 576 patients with chronic musculoskeletal pain. Internal consistency was checked by the Cronbach's alpha coefficient. Construct validity was analysed by performing principal component factor analysis and by comparing CPG dimensions and subscales with the SF-36 questionnaire. Discriminant validity was assessed by comparing the CPG and SF-36 dimensions in patients with and without other health conditions. Factor analysis yielded two factors which accounted for 76.4% of the variance of the questionnaire. Both subscales of the CPG showed satisfying to good internal consistency. Cronbach's alpha was 0.89 for the first factor 'Disability Score' (58.72% of the explained variance) and 0.81 for the second factor 'Characteristic Pain Intensity' (17.70% of the explained variance). Item-total correlations for the subscales were moderate up to high (from 0.500 to 0.771). In comparison with the SF-36, the expected correlations were found when comparing items measuring similar constructs, supporting the concepts of convergent construct validity. Discriminant validity, assessed by comparing the CPG dimensions in patients with and without other health conditions, showed that the CPG shows moderate association with the presence of co-morbidities. Furthermore, the CPG Disability Score was inversely correlated (p=0.01) to years of formal education. In conclusion, the Italian version of the CPG questionnaire has shown to be valid and reliable for evaluating the severity of chronic musculoskeletal pain, with metric properties in agreement with the original, widely used version.

To estimate the prevalence of Raynaud's phenomenon (RP) in an Italian population aged 18 years and above, a validated questionnaire was mailed to a random sample of 3,664 subjects. Sociodemographic data and data regarding the prevalence of RP symptoms were collected. Trained rheumatologists carried out a subsequent standardized clinical examination to confirm diagnosis of RP and to detect associated diseases. The subjects (2,155) completed the questionnaire, with 45 reporting RP [prevalence rate 2.1%, 95% confidence intervals (CI) 1.8-2.4]. The mean age [standard deviation (SD)] was 57.5 (12.7), and 40 (88.8%) were women. Prevalence was found higher in women (3.4%, 95% CI 2.8-4.1) than in men (0.5%, 95% CI 0.2-0.9) (p<0.0001). A connective tissue disease was diagnosed in six (0.28%) subjects, three of the participants (0.14%) were identified as having RP associated to an idiopathic carpal tunnel syndrome, and 36 (1.67%) were diagnosed as having primary RP. Our study has found a lower prevalence of RP than others have reported. There is thought to be an association with climate and ethnic factors. No relationship was found regarding factors that are thought to be among the most relevant triggering factors for RP, e.g., occupational exposure. Differences with previous studies may be related to the current characteristics of the population surveyed.

Background and Aims: Health-related quality of life (HRQOL) assessment is receiving increasing attention as an outcome measure in osteoarthritis (OA). The aims of this study were to compare HRQOL among older adults aged 55 to 78 years with hip and/or knee OA with those without OA, and to assess the influence of selected variables (sex, body mass index, radiographic OA severity, educational level, comorbidities) on HRQOL., Methods: The generic Medical Outcome Study Short Form-36 item health status questionnaire (SF-36) was administered to a cohort of 264 OA patients (105 with hip OA alone, 108 with knee OA alone, and 51 with both hip and knee OA) and 112 healthy controls., Results: Compared with the healthy controls, OA of the lower extremities has a detrimental effect on the eight-scale profile score, as well as on physical and mental summary measures of the SF-36. The most striking impact was seen in the physical measures "physical functioning", "physical role" and "pain" (p<0.0001). No statistically significant differences in SF-36 scores were found among the three groups of OA patients. The physical and mental summary scales of the SF-36 were closely correlated (p<0.0001). One hundred and forty-five patients (54.9%) reported at least one chronic coexisting disease. There was a significant inverse association with measures of comorbidity (number of comorbidities and comorbidity index score) and both physical and mental summary scores of the SF-36 questionnaire. In patients with OA of the knee alone (but not in hip OA alone or hip and knee OA), the SF-36 pain score was inversely correlated with years of formal education (p=0.016). In addition, the impact of hip and knee SF-36 dimensions was not influenced by the degree of radiographic severity., Conclusions: Older adults with OA of the lower extremities undergo a significant impact on multiple dimensions of HRQOL, compared with healthy controls. The use of a generic measure of HRQOL such as the SF-36, in studies of OA where comorbidity is common, should be useful in characterizing the global burden of this disease.

Osteoporosis and its consequent increase in fracture risk is a major health concern for postmenopausal women and older men and has the potential to reach epidemic proportions. The "gold standard" for osteoporosis diagnosis is bone densitometry. However, economic issues or availability of the technology may prevent the possibility of mass screening. The goal of this study was to develop and validate a clinical scoring index designed as a prescreening tool to help clinicians identify which women are at increased risk of osteoporosis [bone mineral density (BMD) T-score -2.5 or less] and should therefore undergo further testing with bone densitometry. Records were analyzed for 1522 postmenopausal females over 50 years of age who had undergone testing with dual-energy X-ray absorptiometry (DXA). Osteoporosis risk index scores were compared to bone density T-scores. Hologic QDR 4500 technology was used to measure BMD at the femoral neck and lumbar spine (L1-L4). Participants who had a previous diagnosis of osteoporosis or were taking bone-active medication were excluded. Receiver-operating characteristic (ROC) analysis was used to identify the specific cutpoint value that would identify women at increased risk of low BMD. A simple algorithm based on age, weight, history of previous low impact fracture, early menopause, and corticosteroid therapy was developed. Validation of this five-item osteoporosis prescreening risk assessment (OPERA) index showed that the tool, at the recommended threshold (or cutoff value) of two, had a sensitivity that ranged from 88.1 [95% confidence interval (CI) for the mean: 86.2-91.9%] at the femoral neck to 90% (95% CI for the mean: 86.1-93.1%) at the lumbar spine area. Corresponding specificity values were 60.6 (95% CI for the mean: 57.9-63.3%) and 64.2% (95% CI for the mean: 61.4-66.9%), respectively. The positive predictive value (PPV) ranged from 29 at the femoral neck to 39.2% at the lumbar spine, while the corresponding negative predictive values (NPVs) reached 96.5 and 96.2%, respectively. Based on this cutoff value, the area under the ROC curve was 0.866 (95% CI for the mean: 0.847-0.882) for the lumbar spine and 0.814 (95% CI for the mean: 0.793-0.833) for the femoral neck. We conclude that the OPERA is a free and effective method for identifying Italian postmenopausal women at increased risk of osteoporosis. Its use could facilitate the appropriate and more cost-effective use of bone densitometry in developing countries.

Health-related quality of life (HRQL) assessment is receiving increased attention as an outcome measure in osteoarthritis (OA). The aims of the study were to assess the health status impact of hip and knee OA in the general older population and to compare the metric properties of the WOMAC disease-specific questionnaire (Western Ontario and McMaster Universities) with generic measures [i.e., the Short Form 36 (SF-36) in patients with OA of the lower extremities]. This cross-sectional survey included a total of 244 patients (99 male, 145 female), aged 50 years and over, with symptomatic OA of the hips (107 patients) and knees (137 patients). All patients completed the WOMAC and the SF-36 questionnaires and were assessed for radiographic damage and for the presence of specific comorbid conditions. The overall impact on health was substantial for both groups of patients with OA of the lower extremities. The most striking impact was seen in OA of the hip for SF-36 "physical function" (p=0.03) and "physical role" (p=0.04), as well as WOMAC "physical function" (p=0.001). Furthermore, impairment of HRQL was only weakly associated with increasing radiographic changes. The SF-36 overall scores showed a better gradient with comorbidities than the WOMAC. This investigation has confirmed that WOMAC is the instrument of choice for evaluating patients with lower limb OA. For a more general insight into patient's health and in particular cross-sectional studies of the elderly, where comorbidity is common, the SF-36 should also be used. This study also provides an estimate of the impact of OA of the hip and knee on HRQL.

The aim of this study was to evaluate the ability of power Doppler sonography (PDS) with ultrasound contrast agent to assess the synovial perfusion changes induced by intra-articular steroid injection therapy in the knee joints of patients with rheumatoid arthritis (RA). Eighteen RA patients (16 women, 2 men) with a history and signs of active knee synovitis were studied. Tenderness was evaluated using Thompson's modified index of synovitis activity. All patients underwent joint aspiration followed by intra-articular injection of 40 mg of triamcinolone hexacetonide. Gray-scale ultrasonography and PDS with an intravenous ultrasound contrast agent (Levovist) examinations were carried out before and 3 weeks after the intra-articular steroid injection. The calculation of the time--intensity curves provided a quantitative estimation of the synovial perfusion. The median values of the index of synovitis activity decreased significantly from 7.0 (95% confidence interval (CI) 6.0-8.0) to 3.0 (95% CI 2.0-4.0) ( p<0.01) 3 weeks after the intra-articular steroid injection. All patients showed a reduction of PDS signal after intra-articular steroid therapy and the baseline and follow up median values of the area underlying time-intensity curves were 7.48 (95% CI 5.79-8.73) and 2.45 (95% CI 1.92-3.61), respectively. The comparison between baseline and follow-up median values of the area under the curves showed a statistically significant reduction of PDS findings ( p<0.01). At follow-up examinations the changes in the index score of the synovitis activity were significantly correlated to the changes in the values of the area underlying time-intensity curves ( r=0.785; p<0.01). A significant correlation was also observed between baseline values of the area underlying time-intensity curves and C-reactive protein (CRP) ( r=0.548; p=0.023). In conclusion, PDS with an intravenous ultrasound contrast agent has been shown to be able to detect changes in synovial perfusion after intra-articular steroid injection and may be an additional useful method in the evaluation of synovial inflammation and in the assessment of the therapeutic response.

Osteoarthritis (OA) is one of the most prevalent and disabling chronic conditions affecting older adults, and is a significant public health problem among adults of working age. The knee is the most frequently involved joint site associated with disability in OA. Diagnosis of OA is primarily based on history and physical examination, but radiographic findings, including asymmetric joint space narrowing (JSN), subchondral sclerosis, osteophyte formation, subluxation, and distribution patterns of osteoarthritic changes are all helpful when diagnosis is uncertain. Structural morphological changes on X-rays are also considered the primary outcome variables for assessing the progression of OA. The development of new methods for prevention and treatment of OA requires improved understanding of the factors that influence its progression. The ability to assess progression quantitatively is a necessary first step in understanding factors that influence the disease process. Depending on the joint studied, several indices are currently used for assessing radiological progression of OA, including individual radiographic features (e.g., marginal osteophytes), composite indices (e.g., Kellgren and Lawrence scoring systems), and quantitative measures (e.g., joint space width measurement). Unfortunately, the review of studies evaluating the longitudinal rate of JSN indicates that the yearly change may be very small and of doubtful clinical significance. This emphasizes the need for further refinement in the definition of radiographic outcomes in prospective clinical trials. This review focuses on the available scoring methods used for the sites most frequently involved in OA (hand, knee, hip) and their various advantages and disadvantages.

The aim of the study was to compare the responsiveness of disease-specific (Arthritis Impact Measurement Scale 2, AIMS2), generic (Medical Outcome Study Short Form Health Survey, SF-36) and preference-based instruments (rating scale, RS and time tradeoff, TTO) to changes in articular status and perceived health in patients with rheumatoid arthritis (RA). Seventy-eight consecutive patients with RA, attending the care facilities of the Department of Rheumatology of Ancona, were recruited in this longitudinal study. In order to assess the responsiveness three strategies were used: effect size (ES), standardised response mean (SRM) and receiver operating characteristic (ROC). There were 55 women and 23 men with a mean age of 56 years (range 19-78) and arthritis duration of 7.1 years (range 6 months to 24 years). Using three-category EULAR criteria as external indicators of improvement/response, 21 patients (27%) reported a significant improvement, 23 (29.5%) moderate improvement, and 34 (43.5%) no change over the 12-month period. The mean change scores in generic and specific health status instruments and utility measures were significantly related to response category. The AIMS2 subscales (physical function, pain, psychological function and social interaction) were slightly more responsive than those of SF-36. The physical and pain dimensions were most sensitive for measuring change over a 12-month period, followed by psychological and social dimensions. For the utility measurement, RS scores were found to be significantly more responsive in detecting changes in preferences than TTO scores. These results may have implications for the application of the health status and utility measures in clinical trials in patients with RA.

To examine either the ultrasonographic (US) features of the parotids and submandibular glands or the blood flow alterations that may occur in the salivary glands of patients with primary Sjögren's syndrome (pSS) we studied 30 female patients with pSS and 30 controls suffering from dry mouth not due to pSS. All measurements were taken by the same examiner, who used the same equipment to avoid interobserver variability. The US parameters recorded (parenchymal homogeneity, echogenicity, size of the glands and posterior glandular border) were scored according to a previously described scoring system. For each waveform, peak systolic velocity (PSV) and resistive index (RI) were measured at the external carotid artery in the examination of the parotids and at the facial artery within the submandibular glands before and during lemon juice stimulation. On the basis of the degree of chronic inflammatory changes at minor salivary gland (MSG) biopsy, chronic sialadenitis (CS) was defined as mild in 10 and severe in 20 pSS patients. Abnormal US scores were obtained in 26/30 (86.6%) pSS patients and in 9/30 (30%) controls. Moreover, in pSS patients the US scores were sigificantly higher than in the control group (p=-0.0001). The mean (+/- SD) difference between the PSV values taken from parotids and submandibular glands before and during lemon juice stimulation was statistically significant (p=0.003 and p=0.01, respectively) in the controls. On the other hand, no significant changes in the PSV values were found in the whole group of pSS patients. However, the changes in PSV values before and during lemon juice stimulation were statistically significant in both parotids (p=0.019) and submandibular glands (p=0.012), and not significantly different from those in the controls in pSS patients with mild CS. The variability of RI taken from the salivary glands before and during lemon juice stimulation was not statistically significant in either pSS patients or controls. US abnormalities were detected in the majority of pSS patients and their severity was significantly greater than those recorded in the controls. Of the colour Doppler sonographic (CDS) parameters only PSV was influenced by the degree of chronic inflammation, as shown at the MSG biopsy, suggesting that PSV may reflect the vascular changes occurring in the salivary glands during the course of an autoimmune disease such as pSS.

To explore common patterns of interstitial lung disease (ILD) in symptomless patients with connective tissue disease (CTD), we applied factorial analysis to determine the relationship among the factors. A selected cohort of 71 non-smoking patients with a confirmed diagnosis of CTD [24 with primary Sjögren's syndrome (pSS), 21 with systemic sclerosis (SS), 20 with rheumatoid arthritis (RA) and six with polymyositis/ dermatomyositis (PM/DM)] were identified. The diagnostic techniques included pulmonary function tests, bronchoalveolar lavage (BAL), chest radiographs and high-resolution computed tomography (HRCT). Disease extent and severity were assessed by a radiological and HRCT grading system. Three factors, accounting for 67% of the total variance, were extracted. The first factor (disease duration, diffusing lung capacity, neutrophils and CD8+ T cells on BAL, radiographic score and HRCT reticular score), with the highest percentage of variance (36.5%), defines a fibrotic lung pattern. The second factor (17.9% of variance) identifies an inflammatory lung pattern (macrophages, lymphocytes and eosinophils on BAL and HRCT ground-glass score). The third factor (12.6% of variance) represents a ventilatory function pattern (forced vital capacity, total lung capacity and forced respiratory volume in 1 s). The negative correlation between the fibrotic lung pattern and ventilatory function pattern, but not with the inflammatory lung pattern, suggests the presence of a significant derangement of the alveolar structures. In conclusion, application of factor analysis reveals various lung disease patterns in patients with CTD that might have different prognostic implications.

Adult-onset Still's disease (AOSD) is a rare disorder of unknown aetiology, characterised by high spiking fever, an evanescent, erythematous, maculopapular rash, arthralgia or arthritis, lymphadenopathy, hepatosplenomegaly, sore throat and serositis. It is associated with marked leukocytosis, high erythrocyte sedimentation rate, increased level of serum ferritin and negative rheumatoid factor and antinuclear antibody tests. Here we report a patient in whom an urticaria-like rash was an uncommon presenting clinical feature of AOSD. To our knowledge, this association has only been reported once before.

Pneumonitis is emerging as one of the most unpredictable and potentially serious, adverse effects of treatment with MTX. Its prevalence in rheumatoid arthritis (RA) has been estimated from several retrospective and prospective studies to range from 0.3% to 18%. On the other hand, MTX-induced pneumonitis seems to be very rare in psoriatic arthritis (PsA). Our review of 194 RA patients and 38 PsA patients receiving MTX has identified four RA patients and one PsA patient with MTX-induced pneumonitis, giving a prevalence of 2.1% and 0.03%, respectively. Diagnosis was suggested by clinical history and radiographic findings, but the bronchoalveolar lavage plays an important role both in excluding infectious agents and in providing information for understanding the pathogenesis of lung injury. The presence of a lymphocyte alveolitis with a predominance of CD4+ T cells in 3 RA patients and CD8+ T cells with a concomitant increase in neutrophils in another case suggests that immunologically mediated reactions may be one damage mechanism in MTX-induced pneumonitis. Although risk factors for MTX-induced pulmonary toxicity are poorly understood, the presence in 3 out of 5 of our patients of pre-existing lung disease, represented by diffuse interstitial changes on chest X-ray, and mild bronchial asthma in two RA patients and by pulmonary silicosis in the patient with PsA may account for a predisposition to the development of MTX pneumonitis.

The aim of this study was to assess the correlations of the serum soluble interleukin 2 receptor (sIL-2R) concentrations with disease activity parameters and response to treatment with second line drugs in patients with rheumatoid arthritis (RA). Sixty-seven patients with active disease completed a 24-week, open, randomized study of methotrexate (MTX) versus sulphasalazine (SSZ) or hydroxychloroquine (HCQ). Serum sIL-2R levels were evaluated before entry and after 24 weeks by ELISA. Serum sIL-2R were significantly higher in RA patients than in controls (P = 0.0001) and correlated significantly only with erythrocyte sedimentation rate (P = 0.03) and with Chronic Arthritis Systemic Index (P = 0.01) at study entry. No correlation was found between serum sIL-2R and other laboratory and clinical indices of disease activity. After 24 weeks of treatment no differences in serum sIL-2R in comparison with basal levels were found in either responding or in non-responding patients, although the mean reduction of sIL-2R was more marked in the MTX-treated cohort than in the HCQ and SSZ-treated groups. These data suggest that in RA the measurement of sIL-2R should be used with caution as an isolated index of disease activity and that it is not a useful marker of response to treatment with second line drugs.

Carpal tunnel syndrome (CTS) may be associated with endocrinopathies, such as hypothyroidism and acromegaly. A direct relationship between CTS and hyperthyroidism has recently been suggested. We now report a case in which bilateral CTS developed after treatment of Graves' disease, thus, questioning the possibility of a relationship between these two disease processes.