The EULAR Sjögren's syndrome (SS) disease activity index (ESSDAI) is a systemic disease activity index that was designed to measure disease activity in patients with primary SS. With the growing use of the ESSDAI, some domains appear to be more challenging to rate than others. The ESSDAI is now in use as a gold standard to measure disease activity in clinical studies, and as an outcome measure, even a primary outcome measure, in current randomised clinical trials. Therefore, ensuring an accurate and reproducible rating of each domain, by providing a more detailed definition of each domain, has emerged as an urgent need. The purpose of the present article is to provide a user guide for the ESSDAI. This guide provides definitions and precisions on the rating of each domain. It also includes some minor improvement of the score to integrate advance in knowledge of disease manifestations. This user guide may help clinicians to use the ESSDAI, and increase the reliability of rating and consequently of the ability to detect true changes over time. This better appraisal of ESSDAI items, along with the recent definition of disease activity levels and minimal clinically important change, will improve the assessment of patients with primary SS and facilitate the demonstration of effectiveness of treatment for patients with primary SS.
Objectives Dietary berries, such as strawberries are rich in bioactive compounds and have been shown to lower cardiometabolic risks. We examined the dose-response effects of two dietary achievable doses of strawberries on glycemic control and lipid profiles in adults. Methods In this 14-week randomized controlled crossover study, adults with obesity and elevated serum LDL-cholesterol were assigned to one of the three arms for four weeks separated by a one-week washout period: control powder, one serving strawberries (low dose: 13 g powder/day), and 2.5 servings strawberries (high dose: 32 g powder/day). Participants were instructed to follow their usual diet and lifestyle while refraining from consuming other berries and related products throughout the study. Blood samples and anthropometric measures were collected at baseline and at the end of each four-week phase of intervention. Results Thirty-three participants completed all three phases of the trial [(mean ± SD): Age: 53 ± 13 y; BMI: 33 ± 3.0 kg/m2). Outcome measures were analyzed using a mixed model analysis of variance with statistical significance set at P < 0.05. Findings revealed significant reduction in fasting insulin as well as homeostatic model of assessment of insulin resistance (HOMA-IR) following the high dose strawberries when compared to the low dose strawberry and control phases. Glucose and conventional lipid profiles did not differ among groups. Total and small LDL particle concentrations (nuclear magnetic resonance-determined) were significantly decreased in the high dose strawberry group compared to control and low dose group (P < 0.05). Conclusions These data suggest that consuming strawberries at two and half servings for four weeks significantly improves insulin resistance and LDL particle profiles in adults with features of the metabolic syndrome. Funding Sources Supported by the NIH grant U54GM104938 (Oklahoma Shared Clinical and Translational Resource), OUHSC and the California Strawberry Commission.
Objectives To validate the EULAR scores for assessment of primary Sjögren’s Syndrome (SS): the EULAR SS Disease Activity Index (ESSDAI), the EULAR SS Patient Reported Index (ESSPRI). Methods Prospective international validation study with 2 visits: baseline and 6 months. At each physicians completed ESSDAI, SS disease activity index (SSDAI), Sjögren’s Systemic Clinical Activity Index (SCAI) and physician global assessment (PhGA); and patients completed ESSPRI, Sicca Symptoms Inventory (SSI), Profile of Fatigue and Discomfort (PROFAD) and patient global assessment (PGA). Construct validity (using correlations with gold standard), responsiveness (using standardized response mean [SRM]) and reliability (intraclass correlation coefficient [ICC]) were evaluated and compared between each scores. Results 395 patients (96% women, mean age 55.4 ± 13.7 years, 79% with anti-SSA and/or anti-SSB antibodies) from 15 countries have been included. At enrollment, 145 (37%) and 251 (64%) had, respectively, current or either current or past systemic manifestations. EULAR scores had higher correlation with gold standard than other scores (ESSDAI with PhGA: rho=0.59; ESSRPI with PGA: rho=0.70). Correlations between patient and systemic scores were very low (rho ranging from 0.07 to 0.29). All systemic scores had similar large responsiveness in improved patients (SRM= 0.69 to 0.82). Responsiveness of patients scores was low in patient experiencing improvement of their symptoms but was significantly higher for ESSPRI compared to SSI and PROFAD ((SRM=0.37 vs. 0.04 and 0.16; p=0.006 and 0.049 for SRM comparisons). Reliability was assessed in a subgroup of 47 and 62 patients, for systemic and patients scores, respectively. Reliability was very good for all scores (ICC=0.83 to 0.96). Conclusions ESSDAI and ESSPRI had good construct validity. All scores were reliable. Systemic scores were sensitive to change in patients whose disease activity improves. Patient scores had a small sensitivity to change. However, ESSPRI was significantly better than SSI and PROFAD. The poor correlation between systemic and patients scores confirms that these 2 components are different and should be evaluated separately. Disclosure of Interest: None Declared
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