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.

Measuring functional disability in early rheumatoid arthritis: the validity, reliability and responsiveness of the Recent-Onset Arthritis Disability (ROAD) index.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Health-related quality of life in multiple musculoskeletal conditions: a cross-sectional population based epidemiological study. II. The MAPPING study.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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 level < 0.001), 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 level < 0.001), 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 level < 0.001), female sex (p = 0.006) and high BMI (p = 0.036) with STD were also found. Similar results were found for EQ-5D. CONCLUSIONS: 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.

Development of a functional disability measurement tool to assess early arthritis: the Recent-Onset Arthritis Disability (ROAD) questionnaire.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

[Validation of the Italian versions of the Bath Ankylosing Spondylitis Functional Index (BASFI) and the Dougados Functional Index (DFI) in patients with ankylosing spondylitis]. / Validazione delle versioni italiane del Bath Ankylosing Spondylitis Functional Index (BASFI) e del Dougados Functional Index (DFI) in pazienti con spondilite anchilosante.

OBJECTIVES: The Bath Ankylosing Spondylitis Functional Index (BASFI) and the Dougados Functional Index (DFI) are the most commonly used instruments to measure functioning in ankylosing spondylitis (AS). The aim of this study was to translate, adapt and validate these instruments into the Italian language. METHODS: The BASFI and DFI questionnaires were translated into Italian by two independent bilingual physicians who were familiar with the medical aspects of AS and by one professional translator. Two rheumatologists familiar with instrument validation, and who were aware of the purpose of the study, examined semantic, idiomatic and conceptual issues and produced by consensus unified versions of each instrument. English back-translations from the Italian were done by a professional translator unaware of the original version. Both English versions were compared, and where needed, modifications to the Italian versions were made. RESULTS: A total of 95 patients were included: 77 males, age (mean+/-SD) 47.9+/-9.3years, and disease duration 12.4+/-6.6 years, and 18 females, age 45.9+/-8.7 years, and disease duration 11.3+/-8.2 years. Reliability, measured in 23 patients participating a physiotherapy program, showed an acceptable one-week test-retest intraclass correlation coefficient (ICC)--BASFI ICC: 0.91, 95% CI: 0,87-0.94 and DFI ICC: 0.86, 95% CI: 0.83-0.90. The internal consistency was 0.90 (Cronbach's alpha) for the BASFI and 0.87 for the DFI. For validity the functional indices were correlated with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Bath Ankylosing Spondylitis Patient Global Score (BAS-G), modified Health Assesment Questionnaire (HAQ-S), SF-36 physical component summary (SF-36 PCS), stiffness, pain, physician's assessment of disease activity, Bath AS Radiology Index-total (BASRI-t), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP). The functional indices (BASFI and DFI) were correlated with each other (p<0.0001) and with activity variables. There was no significant relationship between functional indices and BASRI-t and acute phase reactants. The receiver operating characteristic (ROC) curve analysis indicated that the BASFI ranked superior compared to HAQ-S, (p = 0.019) and SF36 PCS (p = 0.002), but not respect to DFI (p = NS), in distinguishing between patients with high and low disease activity. CONCLUSIONS: The Italian versions of the BASFI and DFI showed adequate reliability and validity in patients with AS. Because of psychometric advantages, the BASFI may be preferred in clinical trial settings. However, sensitivity to changes due to drug therapy and/or rehabilitation remains to be determined.

[Assessment of circadian rhythm in pain and stiffness in rheumatic diseases according the EMA (Ecologic Momentary Assessment) method: patient compliance with an electronic diary]. / Valutazione del ritmo circadiano del dolore e della rigidità nelle malattie reumatiche secondo la metodica EMA (Ecologic Momentary Assessment): compliance del paziente con un diario elettronico.

BACKGROUND: Many researchers have used paper diaries in an attempt to capture patient experience. However, patient non-compliance with written diary protocols is a serious problem for researchers. Electronic patient experience diaries (eDiary) facilitate Ecologic Momentary Assessment (EMA) study designs by allowing the researcher to administer flexible, programmable assessments and mark each record with a time and date stamp. OBJECTIVES: The objectives of the current study were to evaluate methodological issues associated with real-time pain reports (EMA) using electronic patient experience diaries, to quantify compliance (percentage of the total number of diary reports scheduled that were actually completed), and to examine the circadian rhythm in pain and stiffness of patients with rheumatic diseases in an ecologically valid manner. METHODS: In this cross-sectional study we examined 49 patients with rheumatic diseases (14 patients with rheumatoid arthritis, 18 with fibromyalgia and 17 with osteoarthritis of the knee), attending the care facilities of the Department of Rheumatology of Università Politecnica delle Marche. All patients fulfilling the American College of Rheumatology (ACR) criteria. The assessment of pain and stiffness in all patients were repeated seven times a day (8 A.M., 10 A.M., 12 A.M., 2 P.M., 4 P.M., 6 P.M. and 8 P.M.) on seven consecutive days using an electronic diary (DataLogger® - Pain Level Recorder). A datalogger is newly developed electronic instrument that records measurements of pain and stiffness over time. Dataloggers are small, battery-powered devices that are equipped with a microprocessor. Specific software is then used to select logging parameters (sampling intervals, start time, etc.) and view/analyse the collected data. Compliance is based on the time and date record that was automatically recorded by the devices. RESULTS: Using the data from the electronic diary, we determined that the average verified compliance rate for pain and stiffness were 93.8 and 93.6%, respectively. The two highest compliance rates were observed in patients with rheumatoid arthritis (95.6 and 95.2%, respectively). There were no statistically significant difference in compliance between females and males or patients above or below 60 years old. Significant circadian rhythms in patients with RA and OA of the knee were detected in pain and stiffness. No rhythm in pain or stiffness was observed in subjects with fibromyalgia. CONCLUSIONS: We conclude that collection of subjective data using electronic diary in rheumatologic setting is a feasible method than can be adopted with high compliance rates across a range of patient demographic subgroups. The identification of diurnal cycles of self-reported pain and stiffness, using EMA method, has important implications for patients with respect to planning their daily activities and in developing individual therapeutic programs with respect to diurnal variability, which therefore may be more effective.

[The impact of vertebral fractures on quality of life in postmenopausal women with osteoporosis. Validity of the Italian version of mini-Osteoporosis Quality of Life Questionnaire.]. / Impatto sulla qualità della vita delle fratture vertebrali in donne in età postmenopausale affette da osteoporosi. Validità della versione italiana del mini-Osteoporosis Quality of Life Questionnaire.

BACKGROUND: Vertebral fracture is one of the most commonly occurring osteoporotic fractures. Vertebral fractures associated with osteoporosis are a major cause of pain in elderly people and may hardly affect patient's health-related quality of life (HRQOL), making this an important parameter for assessment in these patients. Studies comparing the performance of HRQOL instruments in osteoporosis are lacking. OBJECTIVES: The purposes of this study were to assess the effect of vertebral fractures on health HRQOL in post-menopausal women with osteoporosis and to investigate the validity of the Italian version of the mini-Osteoporosis Quality of Life Questionnaire (mini-OQOL) in a clinical setting. METHODS: Patients were divided into two study groups, according to fracture status: vertebral fractures (41 patients) and no vertebral fractures (27 patients). Baseline assessments of anthropometric data, medical history, and prevalent fracture status were obtained from all participants. All of the participants were evaluated using both disease-targeted mini-OQOL and QUALEFFO, generic instrument (EUROQoL), disability scale (Roland Morris Disability questionnaire- RMDQ) and chronic pain grade questionnaire. RESULTS: Vertebral fractures due to osteoporosis significantly decreases scores on physical function, socio-emotional status, clinical symptoms, and overall HRQOL. Both disease-targeted questionnaires showing an association between the number of prevalent vertebral fractures and decreased HRQOL. Significant correlations existed between scores of similar domains of mini-OQOL and the QUALEFFO, especially for symptoms, physical function, activities of daily living and social function. The receiver operating characteristic (ROC) curve analysis of mini-OQOL and the QUALEFFO indicated that both questionnaires were significantly predictive of vertebral fractures. Number of concomitant diseases presented a weak significant correlation with EUROQoL (p=0.041). CONCLUSIONS: Our study suggests that the patients with vertebral fractures due to osteoporosis have a relevant impairment in quality of life. Both disease-targeted questionnaires discriminated between patients with and without vertebral fractures though the mini-OQOL, originally developed to measure the effect of vertebral fractures on quality of life, showed slightly better discriminant power. The benefit of the mini-OQOL is that it is efficient, self administered, and requires 3-4 minutes to complete.

Responsiveness of health status measures and utility-based methods in patients with rheumatoid arthritis.

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.

[Disability and quality of life of patients with rheumatoid arthritis: assessment and perspectives]. / La disabilità e la qualità della vita dei pazienti con artrite reumatoide: valutazione e prospettive.

Functional disability and quality of life in rheumatoid arthritis (RA) are key outcomes that determine patient's demand for care, and influence their compliance and satisfaction with treatment. In the recent years the demand to collect outcome data is ever increasing as a means for the validation of quality care, and the development of effective outcome measures has become a major thrust of health research and has contributed to better understanding the relationship between outcomes and specific elements of health care. There are several disease-generic and specific instruments available that have proven valuable in outcome testing in RA. The first instruments provide a broad picture of health status across a range of conditions, whereas the latter are more sensitive to the disorder under consideration and are therefore more likely to reflect clinically important changes. When necessary, this kind of scales can be supplemented with specialised domain-specific scales (for the assessment of psychological well-being, social role functioning, or other). As in other fields, these measurement instruments mainly focus on: a) clinical signs and symptoms (physiologic and biologic); b) physical and/or cognitive functioning; c) well-being and emotional functioning; d) social functioning; e) satisfaction with care and other personal constructs (life satisfaction, spirituality, etc.); f) health-related quality of life (HRQOL). Over the past 20 years, there has been a better recognition of the patient's point of view as an important component in the assessment of health care outcomes, and an increasing interest in HRQOL as an important area of research, due to the rising burden of chronic diseases, longer expectation of life, the growing number of health intervention alternatives, and greater emphasis on humanising health care. In addition, decision-making on issues of cost-effectiveness across health inputs and resource allocation across health programs is likely to be more sound if informed by HRQOL evidence. This paper reviews the literature and discusses the major issues regarding mainly measures of physical function (e.g., mobility or daily activities) and health status, including some so called HRQOL instruments.