[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

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

Distal brachii biceps tendon repair with bone tunnel

Objective: subcutaneous rupture of the distal biceps tendon is the most common tendon injury of the elbow. Recently with the best understanding of the anatomy and the advent of new fixations many surgeons took up the use of single incision surgery, as an alternative to replace the tendon. Materials and methods: 40 male patients (average age 45,2) operated from 2006 to 2016. Results: only 3 cases had post-surgery complications: 1. a transient neurapraxia of the posterior interosseous nerve, 2. a radio-ulnar synostosis with stiffness in pronation and supination, and 3. a stiffness of the elbow in extension of approximately 5° degrees. Conclusions: the reinsertion of the distal biceps tendon with bone tunnel in anatomical site is a safe, reproducible technique that offers excellent clinical results. Patients achieve a complete recovery of the elbow range of motion, strength and endurance, with minimal risk of complication

Validation of the Italian versions of the Bath Ankylosing Spondylitis Functional Index (BASFI) and the Dougados Functional Index (DFI) in patients with ankylosing spondylitis

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

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

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 laking. Objectives: The purposes of this study were to assess the effect of vertebral fractures on health HRQOL in postmenopausal 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-targered 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 overal 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

Loss of VGLUT3 Produces Circadian-Dependent Hyperdopaminergia and Ameliorates Motor Dysfunction and l-Dopa-Mediated Dyskinesias in a Model of Parkinson\u27s Disease.

UNLABELLED: The striatum is essential for many aspects of mammalian behavior, including motivation and movement, and is dysfunctional in motor disorders such as Parkinson\u27s disease. The vesicular glutamate transporter 3 (VGLUT3) is expressed by striatal cholinergic interneurons (CINs) and is thus well positioned to regulate dopamine (DA) signaling and locomotor activity, a canonical measure of basal ganglia output. We now report that VGLUT3 knock-out (KO) mice show circadian-dependent hyperlocomotor activity that is restricted to the waking cycle and is due to an increase in striatal DA synthesis, packaging, and release. Using a conditional VGLUT3 KO mouse, we show that deletion of the transporter from CINs, surprisingly, does not alter evoked DA release in the dorsal striatum or baseline locomotor activity. The mice do, however, display changes in rearing behavior and sensorimotor gating. Elevation of DA release in the global KO raised the possibility that motor deficits in a Parkinson\u27s disease model would be reduced. Remarkably, after a partial 6-hydroxydopamine (6-OHDA)-mediated DA depletion (∼70% in dorsal striatum), KO mice, in contrast to WT mice, showed normal motor behavior across the entire circadian cycle. l-3,4-dihydroxyphenylalanine-mediated dyskinesias were also significantly attenuated. These findings thus point to new mechanisms to regulate basal ganglia function and potentially treat Parkinson\u27s disease and related disorders. SIGNIFICANCE STATEMENT: Dopaminergic signaling is critical for both motor and cognitive functions in the mammalian nervous system. Impairments, such as those found in Parkinson\u27s disease patients, can lead to severe motor deficits. Vesicular glutamate transporter 3 (VGLUT3) loads glutamate into secretory vesicles for neurotransmission and is expressed by discrete neuron populations throughout the nervous system. Here, we report that the absence of VGLUT3 in mice leads to an upregulation of the midbrain dopamine system. Remarkably, in a Parkinson\u27s disease model, the mice show normal motor behavior. They also show fewer abnormal motor behaviors (dyskinesias) in response to l-3,4-dihydroxyphenylalanine, the principal treatment for Parkinson\u27s disease. The work thus suggests new avenues for the development of novel treatment strategies for Parkinson\u27s disease and potentially other basal-ganglia-related disorders

Rheumatoid arthritis - treatment: 180. Utility of Body Weight Classified Low-Dose Leflunomide in Japanese Rheumatoid Arthritis

Background: In Japan, more than 20 rheumatoid arthritis (RA) patients died of interstitial pneumonia (IP) caused by leflunomide (LEF) were reported, but many of them were considered as the victims of opportunistic infection currently. In this paper, efficacy and safety of low-dose LEF classified by body weight (BW) were studied. Methods: Fifty-nine RA patients were started to administrate LEF from July 2007 to July 2009. Among them, 25 patients were excluded because of the combination with tacrolimus, and medication modification within 3 months before LEF. Remaining 34 RA patients administered 20 to 50 mg/week of LEF were followed up for 1 year and enrolled in this study. Dose of LEF was classified by BW (50 mg/week for over 50 kg, 40 mg/week for 40 to 50 kg and 20 to 30 mg/week for under 40 kg). The average age and RA duration of enrolled patients were 55.5 years old and 10.2 years. Prednisolone (PSL), methotrexate (MTX) and etanercept were used in 23, 28 and 2 patients, respectively. In case of insufficient response or adverse effect, dosage change or discontinuance of LEF were considered. Failure was defined as dosages up of PSL and MTX, or dosages down or discontinuance of LEF. Last observation carried forward method was used for the evaluation of failed patients at 1 year. Results: At 1 year after LEF start, good/ moderate/ no response assessed by the European League Against Rheumatism (EULAR) response criteria using Disease Activity Score, including a 28-joint count (DAS28)-C reactive protein (CRP) were showed in 14/ 10/ 10 patients, respectively. The dosage changes of LEF at 1 year were dosage up: 10, same dosage: 5, dosage down: 8 and discontinuance: 11 patients. The survival rate of patients in this study was 23.5% (24 patients failed) but actual LEF continuous rate was 67.6% (11 patients discontinued) at 1 year. The major reason of failure was liver dysfunction, and pneumocystis pneumonia was occurred in 1 patient resulted in full recovery. One patient died of sepsis caused by decubitus ulcer infection. DAS28-CRP score was decreased from 3.9 to 2.7 significantly. Although CRP was decreased from 1.50 to 0.93 mg/dl, it wasn't significant. Matrix metalloproteinase (MMP)-3 was decreased from 220.0 to 174.2 ng/ml significantly. Glutamate pyruvate transaminase (GPT) was increased from 19 to 35 U/l and number of leukocyte was decreased from 7832 to 6271 significantly. DAS28-CRP, CRP, and MMP-3 were improved significantly with MTX, although they weren't without MTX. Increase of GPT and leukopenia were seen significantly with MTX, although they weren't without MTX. Conclusions: It was reported that the risks of IP caused by LEF in Japanese RA patients were past IP history, loading dose administration and low BW. Addition of low-dose LEF is a potent safe alternative for the patients showing unsatisfactory response to current medicines, but need to pay attention for liver function and infection caused by leukopenia, especially with MTX. Disclosure statement: The authors have declared no conflicts of interes