Validity and reliability of the Italian version of the ECOS-16 questionnaire in postmenopausal women with prevalent vertebral fractures due to osteoporosis.

OBJECTIVE: 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. METHODS: 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). RESULTS: 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 (p<0.001) and the effect of the first fracture was already statistically significant (p<0.01). 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. CONCLUSION: 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.

Diagnostic performance of tear function tests in Sjogren's syndrome patients.

OBJECTIVE: To evaluate the diagnostic performance of the tests included in primary Sjogren's syndrome (SS-I) diagnostic criteria (Schirmer I, break-up time, vital dye staining) and to compare them with other examinations related to the ocular surface status. METHODS: Clinical and cytological data were collected from 177 patients (62 SS-1, 56 non-SS autoimmune diseases, 59 Sicca syndrome). Tear tests included: a validated questionnaire on symptoms, Schirmer I, Jones test, Ferning test, BUT, corneal aesthesiometry, tear clearance test, lissamine green staining, impression conjunctival cytology. Data were statistically evaluated and sensitivity, specificity, likelihood ratio (LR+), receiver-operating characteristics (ROC) curves were calculated for each test. RESULTS: Data showed a poor diagnostic performance of Schirmer test I (sensitivity 0.42; specificity 0.76; LR+1.75) and BUT (sensitivity 0.92; specificity 0.17; LR+1.11) (area under the curve in ROC analysis <0.58). Validated subjective symptoms questionnaire (sensitivity 0.89; specificity 0.72; LR+3.18), Jones test (sensitivity 0.60; specificity 0.88; LR+5), corneal aesthesiometry (sensitivity 0.80; specificity 0.67; LR+2.42), and tear clearance test (sensitivity 0.63; specificity 0.84; LR+3.93), all exhibited a high diagnostic performance (area under the curve in the ROC analysis always >0.70). Lissamine green staining exhibited the best performance (sensitivity 0.63; specificity 0.89; LR+5.72) but the result could be distorted by an incorporation bias. CONCLUSIONS: Our data suggest to implement the items for ocular signs and symptoms contained in many SS-I diagnostic criteria with the use of a validated questionnaire, performance of Jones test, corneal aesthesiometry measurement, and tear clearance rate evaluation.

A proposal of new ocular items in Sjögren's syndrome classification criteria.

OBJECTIVE: To verify whether ocular surface tests other than those included in primary Sjögren's syndrome (SS-I) classification criteria (Schirmer I, Break up Time, vital dye staining) may contribute to SS I diagnosis. METHODS: Two hundred and sixty-two patients (78 SS-1, 91 non-SS autoimmune diseases, 93 Sicca syndrome) filled a validated questionnaire on symptoms and were evaluated by Schirmer test without (Schirmer I) and with (Jones test) topical anaesthesia, Break Up Time (BUT), corneal aesthesiometry, tear clearance rate, vital dye (lissamine green) staining, impression conjunctival cytology, concentration of tear lysozyme and lactoferrin. Thresholds were selected from Receiver Operating Curves; sensitivity, specificity, likelihood ratio (LR+), predictive values were calculated for each test. A logistic regression model was constructed representing the best diagnostic index for SS. RESULTS: Data showed a poor diagnostic performance of Schirmer test I (LR+ 1.38) and BUT (LR+ 1.05); results from lissamine green staining may be unreliable due to incorporation bias. Tear lactoferrin (LR+ 4.52), Jones test (LR+ 6.24), tear lysozyme (LR+ 8.0), symptom questionnaire (LR+ 8.62), tear clearance rate (LR+ 18.73) and corneal aesthesiometry (LR+ 20.96) exhibited high diagnostic performance also taken together in the regression model. CONCLUSION: Because many of the tests we have screened in this study can be carried out by a trained ophthalmologist in any clinical setting, we recommend that ocular surface impairment is studied with the combination of tests proved to be helpful for the SS I diagnosis.

[Ocular surface analysis in patients affected with rheumatic diseases]. / Analisi della superficie oculare in pazienti affetti da malattie reumatiche.

OBJECTIVE: The international criteria for primary Sjögren's Syndrome (SS I) diagnosis (Vitali et al. 2002) include the Schirmer test I and vital dye staining as tests for ocular surface involvement, but diagnosis can be reached also when the item for ocular signs is not satisfied. The purpose of our study was to evaluate the ocular surface in patients with Sjögren's Syndrome, non-Sjögren's autoimmune diseases and Sicca Syndrome, to understand whether the SS I diagnosis can be targeted also on other tests related to the ocular surface status. METHODS: Clinical and cytological data were collected from 122 patients: 40 patients had diagnosis of Primary Sjögren's Syndrome, 51 a non Sjögren's autoimmune disease and 31 had symptoms of dry eye. A validated questionnaire on symptoms was filled by each patient; clinical tests included: Schirmer test I, Jones test, Ferning test, Break Up Time, corneal aesthesiometry, tear clearance test, vital dye staining of the ocular surface, scraping and impression conjunctival cytology. Data were statistically evaluated by using SPSS software and Mann-Whitney analysis on unpaired data. RESULTS: Data show that the subjective symptoms score, tear production, tear turnover, corneal sensitivity and ocular surface integrity are affected in SS I patients, with a statistically significant difference when matched to the other two groups. CONCLUSIONS: Our results suggest to enlarge the spectrum of ocular surface analysis, to support and orient a differential diagnosis among the autoimmune diseases.

Ultrasonography detection of early bone erosions in the metacarpophalangeal joints of patients with rheumatoid arthritis.

OBJECTIVE: To compare ultrasonography (US) and magnetic resonance imaging (MRI) in their capability to detect bone erosions in early-advanced rheumatoid arthritis, where no erosion was evident on conventional radiography (X-ray). METHODS: Metacarpophalangeal (MCP), radiocarpal and ulnocarpal joints of 13 patients with rheumatoid arthritis, with bone erosion that was not detected by conventional X-ray, were examined by US and MRI. Ten controls underwent examination of the same joints by US. RESULTS: None of the controls showed bone erosions at US examination. No significant difference between US and MRI in detecting bone erosion was observed in wrist joints, whereas a significantly higher number of erosions was detected by US in MCP joints. CONCLUSION: US is at least as sensitive as MRI in detecting bone erosions in MCP and wrist joints. Since US examination is a more easily available and less expensive procedure than MRI, our findings justify its use as a diagnostic tool for early arthritis. In addition US may also be utilized in the follow up of patients with an established diagnosis of inflammatory arthritis.

[Femoral neck morphology differentiates femoral neck from vertebral or hip osteoporotic fracture]. / Differenze morfologiche del femore prossimale in donne con osteoporosi postmenopausale con fratture vertebrali o dell'anca.

UNLABELLED: Mineral density and bone geometry are the two main biomechanical factors related to bone resistance to stress. OBJECTIVE: In this study we assess whether differences in the proximal femur geometry (PFG) characterize different types of osteoporotic fractures. METHODS: We studied 533 postmenopausal women aged 50 - 85. They were divided into four groups matched for bone mineral density at the femoral neck; without fractures (165), vertebral fractures (139), trochanteric fractures (102), and hip fractures (127). Dual X-Ray absorptiometry (DXA) scans at the spine and at the hip were carried out to measure bone mineral density and the DXA images were used to define the proximal femur geometry parameters of the hip. RESULTS: Age, height, vertebral BMD and PFG parameters (i.e. femoral neck-shaft angle (NSA) and hip axis length (HAL) were different when all four groups were compared by the Anova test. Patients with vertebral fractures were then compared by multivariate analysis to those with trochanteric fractures. The variables that discriminated the two groups were: age, age at menopause, weight, height, and vertebral BMD, but not PFG. Comparing vertebral to hip fractures the distinguishing variables were: vertebral BMD, height, NSA and HAL. We found that hip fractures had longer HAL and wider NSA than vertebral fractures, whereas no statistically significant differences were found between trochanteric fractures and vertebral fractures concerning PFG. CONCLUSIONS: These data indicate that differences in PFG parameters might have a role in predisposing to femoral neck fracture.

Brucella spondylitis with paravertebral abscess due to Brucella melitensis infection: a case report.

This report describes the case of a 45-year-old woman with a 5-month history of fever, generalized malaise, myalgia, lower back pain and difficulty in walking. Serodiagnosis for brucella, carried out at the onset of symptoms 5 months previously, was negative. When the patient was admitted to our hospital there was contracture of the paraspinal muscles but no peripheral nerve damage. Laboratory tests showed positive agglutination for Brucella and an increase in the rate of dilution from 1/160 to 1/640 over 2 weeks. Radiographs and a computed tomography scan of the spine revealed bone erosion in the posterior borders of the L4-L5 vertebral end plates and a soft tissue mass surrounding the interposed disc and protruding into the spinal canal. Magnetic resonance imaging confirmed the presence of a paraspinal abscess around the affected disc and tissue edema. Culture tests of the blood and abscess tissue, taken by biopsy, were negative. Rifampicin treatment (600 mg daily), combined with a bust cast to immobilize the spine, led to clinical healing without the need for surgery. Because onset symptoms are nonspecific and insidious, in nonrisk subjects a diagnosis of brucellosis may sometimes be suspected only if there are local symptoms. The phenomenon of the absence of positivity in patients with a high antibody titer should also be considered Cases such as that described herein demonstrate the need for culture tests and serodiagnosis, even in nonrisk patients with persistent fever and arthralgia, to prevent the later complications of brucellosis.