[Disability and quality of life of patients with rheumatoid arthritis: assessment and perspectives].

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

The current role of ultrasound in the assessment of crystal-related arthropathies

0Over last few years, the ultrasonography (US) generated an increasing popularity among rheumatologists due to excellent potentiality and numerous applications in rheumatology. Most of the published papers focus mainly to demonstrate the utility of US in early and chronic arthritis, short-term therapy monitoring and guidance for invasive procedures. Less attention has been paid to the potential of this technique in the field of crystal-related arthropathies. By virtue of the high resolution of "new generation" equipments, minimal crystal deposits can be detected even sometime when the radiography was negative. The aim of this paper was to present the principal findings in patients with crystal-related arthropathies

Assessment of circadian rhythm in pain and stiffness in rheumatic diseases according the EMA (Ecologic Momentary Assessment) method: patient compliance with an electronic diary

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 Universita 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 (DataLoggerO - 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 rhytms 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

AB0951 THE ITALIAN FIBROMYALGIA REGISTRY: A NEW WAY OF USING ROUTINE REAL-WORLD DATA CONCERNING PATIENT-REPORTED DISEASE STATUS IN HEALTHCARE RESEARCH AND CLINICAL PRACTICE

Background:Fibromyalgia (FM), the most frequently encountered cause of widespread musculoskeletal pain, affects an estimated 2% of the general Italian population. However, it is not a homogeneous clinical entity, and a number of interacting factors can influence patient prognosis and the outcomes of standardised treatment programmes. Registries are a source of high-quality data for clinical research, but relating this information to individual patients is technically challenging.Objectives:The aim of this article is to describe the structure and objectives of the first Italian Fibromyalgia Registry (IFR), a new web-based registry of patients with FM.Methods:The IFR was developed to collect, store, and share information electronically entered by physicians throughout Italy who are members of the Italian Society of Rheumatology and have a particular interest in FM. It has a web-based architecture that uses two separate servers and an encryption algorithm to ensure the confidentiality and integrity of the exchanged data. The questionnaires included on the platform are the Revised Fibromyalgia Impact Questionnaire (FIQR), the modified Fibromyalgia Assessment Status (ModFAS), and the Polysymptomatic Distress Scale (PDS).Results:The registry includes data relating to 2,339 patients (93.2% female) who satisfied the 1990 or 2010/2011 American College of Rheumatology Classification Criteria for Fibromyalgia at the time of diagnosis. At the time of this analysis, the patients had a mean age of 51.9 years (SD 11.5) and a mean disease duration of 7.3 years (SD 6.9). The majority were married (71.3%), and generally well educated. The overall median FIQR, ModFAS and PDS scores and 25th-75thpercentiles were respectively 61.16 (41.16-77.00), 8.91 (41.16-77.00), and 19.0 (13.00-24.00). The six highest scoring items indicating the greatest impact of the disease on the patients related to fatigue/energy (7.18), sleep quality (6.87), tenderness (6.69), pain (6.68), stiffness (6.66), and environmental sensitivity (6.35). A high proportion of the responding patients reported experiencing pain in the neck (80.46%), upper back (68.36%), and lower back (75.05%).Conclusion:The IFR is the most comprehensive FM registry in Italy, and provides healthcare professionals with a secure, reliable, and easy-to-use means of monitoring the patients' clinical progression, treatment history and treatment responses. This can help clinicians to plan patient management, facilitates research study patient recruitment, and provides the participating pain clinics with statistics based on real-world data. It also helps address the Italian Ministry of Health long-term goal of using precision medicine for chronic pain prevention and treatment. It is hoped that the IFR will enhance both scientific research and clinical practice.References:[1]Drolet BC, Johnson KB: Categorizing the world of registries 2008; 41: 1009–20.[2]Martinez JE, Paiva ES, Rezende MC, Heymann RE, Helfenstein M, Ranzolin A, et al.: EpiFibro (Brazilian Fibromyalgia Registry): data on the ACR classification and diagnostic preliminary criteria fulfillment and the follow-up evaluation. 2017; 57: 129–33[3]Whipple MO, McAllister SJ, Oh TH, Luedtke CA, Toussaint LL, Vincent A: Construction of a US fibromyalgia registry using the Fibromyalgia Research Survey criteria. 2013; 6: 398–99[4]Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg D, et al.: The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. 1990; 33: 160–72Disclosure of Interests:None declare

MonitorNet: studio italiano osservazionale multicentrico per la valutazione del profilo rischio-beneficio dei farmaci biologici nella pratica clinica reumatologica

Over the last decade, several new biologic agents have become available for the treatment of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and psoriasis (Ps). In contrast to conventional disease modifying anti-rheumatic drugs (DMARDs), these biological agents have rapid onset of action and pronounced disease reducing activity when administered as monotherapy or in combination with MTX. Pre-registration randomised clinical trials have compared biological agents against placebo over a limited time span (1-3). Wider use of biologics has resulted in reports of a wide range of adverse events (4), including evidence of reactivation of latent tuberculosis, increased incidence..

Power Doppler sonography and ultrasound contrast agent in assessing rheumatoid synovitis

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Inter-observer agreement of standard joint counts in early rheumatoid arthritis: a comparison with grey scale ultrasonography—a preliminary study

Objectives. The aims of the present study were to assess the inter-observer agreement of standard joint count and to compare clinical examination with grey scale ultrasonography (US) findings in patients with early rheumatoid arthritis (RA). Methods. The study was conducted on 44 RA patients with a disease duration of <2yrs. Clinical evaluation was performed independently by two rheumatologists for detection of tenderness in 44 joints and swelling in 42 joints. All patients underwent US assessment by a rheumatologist experienced in this method and blinded to the clinical findings. Joint inflammation was detected by US when synovial fluid and/or synovial hypertrophy was identified using OMERACT preliminary definitions. The inter-observer reliability was calculated by overall agreement (percentage of observed exact agreement) and kappa (� )-statistics. The reliability of US was calculated in 12 RA patients. Results. There was fair to moderate inter-observer agreement on individual joint counts for either tenderness or joint swelling apart from the glenohumeral joint. US detected a higher number of inflamed joints than did clinical examination. The mean (� S.D.) US joint count for joint inflammation was 19.1 (� 4.1), while the mean (� S.D.) number of swollen joints was 12.6 (� 3.6), with a significant difference of P ¼0.01. Conclusions. Our results provide evidence in favour of the hypothesis that clinical examination is far from optimal for asessing joint inflammation in patients with early RA. Furthermore, this study suggests that US can considerably improve the detection of signs of joint inflammation both in terms of sensitivity and reliability

The Italian registry of aggressive rheumatoid arthritis -- the GIARA project.

Objective. In 1999, the Italian Society of Rheumatology started a project to determine the prevalence and clinical characteristics of aggressive rheumatoid arthritis (ARA). Methods. For I year, all patients with RA for 2 to 2 to 1.5, female sex, and RF positivity. Conditions other than RA were recorded in about 50% of the patients, and only 30%-40% were taking disease modifying antirheumatic drugs. Conclusion. In an Italian RA population, the GIARA (Gruppo Italiano Artrite Reumatoide Aggressiva) criteria for ARA were met by 15% of the patients with disease duration of 2 years, but erosions were seen in 35%. Upon referral, most of the RA patients were inadequately treated and had other conditions

Personal non-commercial use only. The Journal of Rheumatology 1552

ABSTRACT. Objective. Vertebral fractures are a common complication of osteoporosis and may have a negative effect on health-related quality of life (HRQOL). We investigated the effect of prevalent vertebral fractures on HRQOL in patients with osteoporosis. Methods. A cross-sectional multicenter study was carried out among postmenopausal women with primary osteoporosis attending primary care centers and hospital outpatient clinics: 234 women with vertebral fractures and 244 asymptomatic women. Women with secondary osteoporosis or taking medications that affect bone metabolism were excluded. All patients were questioned using the miniOsteoporosis Quality of Life Questionnaire (mini-OQLQ), Medical Outcomes Study Short , and the EuroQuol-5D, after assessment of all clinical variables and anthropometric data. To assess comorbidity we used the Self-Administered Comorbidity Questionnaire (SCQ). Diagnosis of osteoporosis was confirmed in all patients by bone mineral density using dual energy x-ray absorptiometry. Radiographic evaluation was performed by a musculoskeletal radiologist. A total of 483 postmenopausal women, randomly matched for age out of 1579 healthy controls, were chosen to compare the SF-36 scores with respect to patients with and without vertebral fractures due to osteoporosis. A multivariable regression analysis was conducted to identify the strongest determinant for low HRQOL, adjusted for potential confounding variables such as comorbid conditions, education level, and psychosocial status. Results. The vertebral fracture group had significantly lower scores than patients without fractures and controls in all domains of the generic and specific questionnaires. Women with only 1 prevalent fracture had statistically significantly lower HRQOL scores than those without fractures on SF-36 measures of bodily pain, physical functioning, and role function physical (all p &lt; 0.01). HRQOL scores were lower in women with lumbar fractures compared with women with thoracic fractures only when the physical functioning and bodily pain dimensions approached statistical significance. Based on the multivariate analysis, the strongest determinant for low HRQOL was physical functioning (explained by number of vertebral fractures) followed by comorbidity score and age. Adjusted R 2 in the final model was 35.9%. Using the SF-36 summary scales, comorbid conditions predominantly affected either mental or physical health (p &lt; 0.0001). A significant correlation (p &lt; 0.0001) was found between total score on the mini-OQLQ and the mean SCQ comorbidity score. Conclusion MATERIALS AND METHODS Recruitment of patients. In this cross-sectional multicenter study we investigated 478 postmenopausal women (mean age 68.5 yrs, range 48-89 yrs) with primary clinically stable osteoporosis (no change in treatment and no new clinical deformities in the last 12 mo) attending primary care centers and hospital outpatient clinics. The patient group included 234 women (mean age 69 yrs, range 48-89) who had vertebral fractures due to osteoporosis, and a group of 244 asymptomatic osteoporotic women matched for age with the patients with vertebral fractures. The women were screened in 5 rheumatology centers in Northern and Central Italy. A simple algorithm, the OPERA 23 , based on age, weight, history of previous low impact fracture, early menopause, and corticosteroid therapy, was used as a prescreening tool to help clinicians identify which women are at increased risk for osteoporosis. Diagnosis of osteoporosis was confirmed by bone mineral density (BMD) using dual-energy x-ray absorptiometry (DEXA). Osteoporosis was defined as a T score lower than -2.5 (the difference between the measured BMD and the mean value of young adults, expressed in standard deviations), according to the World Health Organization Study Group definition 24 . All measurements at the left femoral neck and lumbar spine (L1-L4), in the anteroposterior position, were obtained using the Hologic scanner (Hologic QDR 4500; Hologic, Bedford, MA, USA). One of the inevitable limitations of the study was the use of different densitometry machines, yielding noncomparable BMD data. Thus, machines at each participating center were cross-calibrated at the beginning of the study using the same spine phantom (supplied by the manufacturer). Each phantom was scanned 10 times at each study center. Quality control procedures were followed according to the manufacturer&apos;s recommendations. T scores were based on a large European and US reference database for BMD 25 . Radiographic evaluation was performed centrally (at the Department of Radiology of the Università Politecnica delle Marche) by an experienced musculoskeletal radiologist. Total spine radiographs in lateral standing views in neutral/flexion/extension and in the lateral decubitus position in flexion/extension were taken with a film-tube distance of 1.8 m. The anterior, central, and posterior heights of each of the vertebral bodies from T4 to L5 in a neutral standing radiograph were measured using calipers. Vertebral fracture was considered present if at least one of 3 height measurements (anterior, middle, posterior) of one vertebra had decreased by more than 20% compared with the height of the nearest uncompressed vertebral body Further, 483 postmenopausal women (mean age 69.1 yrs, range 50-87) randomly matched for age out of 1579 healthy controls were chosen for comparison of SF-36 scores of patients with and without vertebral fractures due to osteoporosis. Subjects with fibromyalgia, chronic back pain, and vertebral or other fractures were excluded. As acquisition of radiographs in the control group study was considered unethical in the context of the study, inclusion in this group depended on oral confirmation that the individual had never 1552 The received a clinical diagnosis of vertebral or other fracture. This sample was selected from a previous cross-sectional population-based study, the MAP-PING (MArche Pain Prevalence INvestigation Group) study Background and illness-related variables. Demographic and socioeconomic information was assessed from patient interviews. Education level was separated into 3 categories based on the Italian school system: 1 = primary school, 2 = secondary school, and 3 = high school or university. The body mass index (BMI, body weight/height 2 ) was used to assess overweight. In all patients the presence of comorbidities was also assessed through patient self-reports using the Self-Administered Comorbidity Questionnaire (SCQ) 28 , a modification of the widely used Charlson Index 29 . The SCQ uses patient interview or questionnaire responses rather than chart abstraction for assessment of comorbidity and is in excellent agreement with the chart-based Charlson Index 28 . We evaluated the rate of endorsement of each of 12 specific conditions as well as the number of conditions endorsed. We also calculated a score with 1 point if the condition was endorsed and additional points if the subject reported currently receiving treatment for it, or if it limited activities. Each condition could, therefore, contribute 0 to 3 points for a maximum of 36 points