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A long-term prospective study was performed to evaluate the safety and long-term outcome of surgical arthroscopy (AS) for persistent rheumatoid (RA) and psoriatic (PsA) knee joint synovitis (KJS). Local signs of joint inflammation (tenderness, swelling, ‘ballottement’) and range of motion (ROM) were scored and the sum, taken as a global outcome measure, was recorded in 17 RA and 18 PsA knees, both before and at follow-up periods of 2, 6, 12, 24 and 36 months after surgical AS (knee joint synovectomy; meniscal curettage, cartilage shaving or chondrectomy, according to the degree of cartilage damage). A survival analysis (Kaplan-Meier) of the long-term outcome of surgical AS treatment and of the predictive value of clinical parameters of knee joint involvement was also performed. No intra- or post-operative morbidity, pain worsening or loss of joint motion was observed and all patients were discharged within 48 h. Comparison of the parameters of knee joint evaluation showed a significant reduction of the signs of joint inflammation and a significant increase in the ROM in all follow-up periods. At 36 months, the survival curves showed a 61.2% cumulative probability of clinical remission and 72.8% of definite improvement. No significant differences in the prognostic importance of RA, compared to PsA diagnosis, were observed, although higher percentages of PsA compared to RA knees (86.3% and 45.7%, respectively) reached the end point of clinical remission at 36 months. KJS duration, radiographic severity and cartilage damage were not predictors of poor long-term outcome of AS synovectomy. Surgical AS treatment for PsA knees with more advanced cartilage damage gave a better long-term outcome. A total of 50.7% of operated knees reached the end point of a KJS relapse at 36 months, the majority (82%) within the initial 18 months of follow-up. Our study indicates that AS synovectomy is a safe procedure requiring short hospitalization which, in combination with second-line medical treatment, can reduce local inflammation in RA and PsA KJS, and preserve knee joint ROM for up to 3 yr. [ABSTRACT FROM PUBLISHER]

SUMMARY The potential role of sonography in evaluating the response to therapy of persistent knee joint synovitis (KJS) was assessed in a longitudinal study in pre- and post-arthroscopic (AS) synovectomy in rheumatoid and psoriatic patients. At entry to the study, ultrasound (US) detection of synovial proliferation was compared with arthroscopic visualization as the ‘gold standard’ reference. US joint effusion and synovial thickness measures and predominant patterns of synovial proliferation were recorded by comparing clinical and US indices before and at 2, 6 and 12 months after AS synovectomy, or after KJS relapse up to 24 months. A 12 month survival analysis of clinical and US outcomes of arthroscopic synovectomy was also performed. US detection of morphology and degree of synovial proliferation was correlated with AS macroscopic evaluation. After AS synovectomy, the clinical index and both US joint effusion and synovial thickness were significantly reduced, whereas US patterns of synovial proliferation did not show significant changes. US and clinical indices were significantly correlated in all follow-up measurements and US joint effusion was significantly increased in the relapsed compared with the non-relapsed KJS group. The probability at 12 months of reaching maximum improvement in US joint effusion and synovial thickness outcomes was 99 and 58%, respectively; that for clinical remission of KJS was 72%. Ultrasound evaluation has proven reliable and accurate by the arthroscopic gold standard in detecting changes of rheumatoid arthritis and psoriatic arthritis knee joint synovitis. The correlation of US with clinical findings in pre- and post-synovectomy patients suggests that sonography can be used as an objective method in monitoring the response to therapy of inflammatory knee joint disease. [ABSTRACT FROM PUBLISHER]

Background: The management of obesity should be multidimensional based on the choice of the treatment and the intensity of the therapeutic-rehabilitative intervention. This meta-analysis aims to compare the changes on body weight and body mass index (BMI) during an inpatient treatment (hospitalized weight loss programs with different durations in terms of weeks) compared with the outpatient phase., Methods: The data obtained from the studies on inpatients have been layered into two categories: short term (studies with follow-up of max 6 months) and long term (studies with follow-up up to 24 months). Furthermore, this study evaluates which of the two approaches show the best impact on weight loss and BMI during 2 follow-ups at 6 to 24 months., Results: The analysis, which included seven studies (977 patients), revealed that the subjects underwent a short hospitalization had greater benefit, compared to those who were followed for a long time. The meta-analyzed mean differences for random effect (MD) showed a statistically significant decrease on BMI of -1.42 kg/m 2 (95% CI: -2.48 to -0.35; P = 0.009) and on body weight -6.94 (95% CI: -10.71 to -3.17; P = 0.0003) for subjects who carry out a short hospitalization compared to outpatients. No reduction of body weight (p = 0.07) and BMI (p = 0.9) for subjects who undergo a long hospitalization compared to an outpatient., Conclusions: A short-term inpatients multidisciplinary weight loss program could be the best choice for the management of obesity and its related comorbidities; on the contrary, if the follow-up is of long duration, the significance is not confirmed. The hospitalization at the beginning of any obesity treatment is significantly better than only outpatients treatment., (© 2023. The Author(s).)

In previous studies, we developed a hydrogel formulation containing silibinin-loaded pomegranate oil nanocapsules (HG-NCSB) that had improved in vivo anti-inflammatory action in comparison to non-encapsulated silibinin. To determine skin safety and whether the nanoencapsulation influences silibinin skin permeation, NCSB skin cytotoxicity, HG-NCSB permeation in human skin, and a biometric study with healthy volunteers were conducted. The formulation of nanocapsules was prepared by the preformed polymer method while the HG-NCSB was obtained by thickening the suspension of nanocarriers with gellan gum. The cytotoxicity and phototoxicity of nanocapsules were assessed in Keratinocytes (HaCaT) and fibroblast (HFF-1) using the MTT assay. The hydrogels were characterized regarding the rheological, occlusive, and bioadhesive properties, and silibinin permeation profile in human skin. The clinical safety of HG-NCSB was determined by cutaneous biometry in healthy human volunteers. NCSB yielded better cytotoxicity results than the blank nanocapsules (NCPO). NCSB did not cause photocytotoxicity, while NCPO and the non-encapsulated substances (SB and pomegranate oil) were phototoxic. The semisolids presented non-Newtonian pseudoplastic flow, adequate bioadhesiveness, and low occlusive potential. The skin permeation demonstrated that HG-NCSB retained a higher SB amount in the outermost layers than HG-SB. In addition, HG-SB reached the receptor medium and had a superior concentration of SB in the dermis layer. In the biometry assay, there was no significant cutaneous alteration after the administration of any of the HGs. Nanoencapsulation promoted greater SB retention in the skin, averted percutaneous absorption, and made the topical use of SB and pomegranate oil safer., (© 2023. The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists.)

Pathogenic variants in TGFBR1 are a common cause of Loeys-Dietz syndrome (LDS) characterized by life-threatening aortic and arterial disease. Generally, these are missense changes in highly conserved amino acids in the serine-threonine kinase domain. Conversely, nonsense, frameshift, or specific missense changes in the ligand-binding extracellular domain cause multiple self-healing squamous epithelioma (MSSE) lacking the cardiovascular phenotype. Here, we report on two novel variants in the penultimate exon 8 of TGFBR1 were identified in 3 patients from two unrelated LDS families: both were predicted to cause frameshift and premature stop codons (Gln448Profs*15 and Cys446Asnfs*4) resulting in truncated TGFBR1 proteins lacking the last 43 and 56 amino acid residues, respectively. These were classified as variants of uncertain significance based on current criteria. Transcript expression analyses revealed both mutant alleles escaped nonsense-mediated mRNA decay. Functional characterization in patient's dermal fibroblasts showed paradoxically enhanced TGFβ signaling, as observed for pathogenic missense TGFBR1 changes causative of LDS. In summary, we expanded the allelic repertoire of LDS-associated TGFBR1 variants to include truncating variants escaping nonsense-mediated mRNA decay. Our data highlight the importance of functional studies in variants interpretation for correct clinical diagnosis., (© 2022. The Author(s), under exclusive licence to European Society of Human Genetics.)

The TNNI3 gene encodes for the cardiac isoform of troponin I, a pivotal component of the sarcomeric structure of the myocardium. While heterozygous TNNI3 missense mutations have long been associated with autosomal dominant hypertrophic and restrictive cardiomyopathies, the role of TNNI3 null mutations has been more debated due to the paucity and weak characterization of reported cases and the low penetrance of heterozygous genotypes. In recent years, however, an increasing amount of evidence has validated the hypothesis that biallelic TNNI3 null mutations cause a severe form of neonatal dilated cardiomyopathy. Here, we expand the case series reporting two unrelated patients afflicted with early onset dilated cardiomyopathy, due to homozygosity for the p.Arg98* TNNI3 variant, which had thus far been documented only in heterozygous patients and apparently healthy carriers, and the recurrent p.Arg69Alafs*8 variant, respectively. A review of previously reported biallelic TNNI3 loss-of-function variants and their associated cardiac phenotypes was also performed.

Background: Branchio-oto-renal syndrome (BOR) is an autosomal dominant disorder characterized by deafness, branchiogenic malformations and renal abnormalities. Pathogenic variants in EYA1, SIX1 and SIX5 genes cause almost half of cases; copy number variants (CNV) and complex genomic rearrangements have been revealed in about 20% of patients, but they are not routinely and commonly included in the diagnostic work-up., Case Presentation: We report two unrelated patients with BOR syndrome clinical features, negative sequencing for BOR genes and the identification of a 2.65 Mb 8q13.2-13.3 microdeletion., Conclusions: We highlight the value of CNV analyses in high level of suspicion for BOR syndrome but negative sequencing for BOR genes and we propose an innovative diagnostic flow-chart to increase current detection rate. Our report confirms a mechanism of non-allelic homologous recombination as causing this recurrent 8q13.2-13.3 microdeletion. Moreover, considering the role of PRDM14 and NCOA2 genes, both involved in regulation of fertility and deleted in our patients, we suggest the necessity of a longer follow-up to monitor fertility issues or additional clinical findings., (© 2022. The Author(s).)

Cadmium is a heavy metal with established adverse effects on human health, namely on bone, liver and kidney function and the cardiovascular system. We assessed cadmium exposure and its correlation with biomarkers of toxicity. We recruited 137 non-smoking blood donors without a history of chronic disease or cancer who resided in the Northern Italy province of Reggio Emilia (mean age 47 years, range 30-60 years) in the 2017-2019 period. We used a semi-quantitative food frequency questionnaire to estimate dietary cadmium intake and urine samples to assess concentrations of urinary cadmium and 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxodG). Median urinary cadmium and 8-oxodG concentrations were 0.21 μg/L (interquartile range (IQR): 0.11-0.34 μg/L) and 3.21 μg/g creatinine (IQR: 2.21-4.80 μg/g creatinine), respectively, while median dietary cadmium intake was 6.16 μg/day (IQR: 5.22-7.93 μg/day). We used multivariable linear and spline regression models to estimate mean differences exposure concentrations. Dietary and urinary cadmium were positively correlated, and both were positively and linearly correlated with 8-oxodG. We found a positive association of urinary cadmium with blood alanine aminotransferase (ALT), total cholesterol, low-density lipoprotein (LDL)-cholesterol and thyroid-stimulating hormone (TSH) concentrations. We also observed a positive association with triglycerides, in both linear (beta regression coefficient = 77.03, 95% confidence interval 32.27-121.78) and non-linear spline regression analyses. Despite the positive correlation between dietary and urinary cadmium estimates, dietary cadmium intake showed inconsistent results with the study endpoints and generally weaker associations, suggesting a decreased capacity to reflect actual cadmium exposure. Overall, these findings suggest that even low levels of cadmium exposure may adversely alter hematological and biochemical variables and induce oxidative stress., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Several studies have described a strong correlation between diet, weight loss, and gut microbiota composition. The aim of this review was to evaluate the potential effects of energy-restricted diets, namely very low calorie diets (VLCDs), very low calorie ketogenic diets (VLCKDs), and very low carbohydrate diets (VLCarbDs), on the composition of the gut microbiota in humans. We performed a literature search using the following terms (with their abbreviations or acronyms): "very low calorie diet", "very low calorie ketogenic diet", "very low carbohydrate diet", and "gut microbiota". Our search strategy retrieved nine eligible studies. Overall, VLCDs and VLCarbDs affected the Bacteroidetes to Firmicutes ratio in obese patients, leading to a reduction in short-chain fatty acid production by fecal microbiota associated with Clostridial cluster XIVa. This reduction particularly affected Roseburia and Eubacterium rectale , the two most abundant butyrate-producing bacteria in human feces. VLCKDs preserved the core fecal microbiome, but altered the composition of fecal microbial populations in relation to the plasma metabolome and fecal bile acid composition. In particular, VLCKD-induced weight loss resulted in a reduction in E. rectale and Roseburia , an increase in Christensenellaceae and Akkermansia while not all studies show a decrease in Faecalibacterium prausnitzii . Although very few studies have analyzed the effects of VLCarbDs and VLCDs on gut microbiota, significant diet-induced changes in fecal microbiota composition have been observed. Further studies are needed., Competing Interests: PB, IS and RM were employed by company PronoKal Group. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Rondanelli, Gasparri, Peroni, Faliva, Naso, Perna, Bazire, Sajuox, Maugeri and Rigon.)

Emerging literature suggests that diet plays an important modulatory role in rheumatoid arthritis (RA) because diet is an environmental factor that affects inflammation, antigen presentation, antioxidant defense mechanisms and gut microbiota. Patients with RA frequently ask their doctors about which diets to follow, and even in the absence of advice from their physicians, many patients are undertaking various dietary interventions. Given this background, the aim of this review is to evaluate the evidence to date regarding the ideal dietary approach for management of RA in order to reduce the counteracting inflammation, and to construct a food pyramid for patients with RA. The pyramid shows that carbohydrates should be consumed every day (3 portions of whole grains, preferably gluten free), together with fruits and vegetables (5 portions; among which fruit, berries and citrus fruit are to be preferred, and among the vegetables, green leafy ones.), light yogurt (125 ml), skim milk (200 ml), 1 glass (125 ml) of wine and extra virgin olive oil; weekly, fish (3 portions), white meat (3 portions), legumes (2 portions) eggs (2 portions), seasoned cheeses (2 portions), and red or processed meats (once a week). At the top of the pyramid, there are two pennants: one green means that subjects with RA need some personalized supplementation (vitamin D and omega 3) and one red means that there are some foods that are banned (salt and sugar). The food pyramid allows patients to easily figure out what to eat., Competing Interests: Conflict of Interest The authors declare non conflict of interests., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)

The aim of this systematic review and meta-analysis is to assess the effectiveness of probiotics in inducing body weight loss in patients with overweight or obesity with related metabolic diseases. The research was carried out on PubMed and Scopus, focusing on studies reporting the effect on anthropometric measures (weight, body mass Index (BMI), waist circumference (WC), and hip circumference (HC) after administration of various probiotic strains compared to placebo. Twenty randomized controlled trials, that included 1411 patients, were considered. The meta-analyzed mean differences (MD) for random effects showed no significant decrease in body weight after probiotic supplementation (-0.26 kg [-075, 0.23], p = 0.30), while a significant BMI decrease was found (-0.73 kg/m 2 [-1.31, -0.16], p = 0.01). For WC and HC, the meta-analyzed MD for random effects showed a significant decrease (WC: -0.71 cm [-1.24; -0.19], p = 0.008 and HC: -0.73 cm [-1.16; -0.30], p = 0.0008). The risk of bias was also evaluated considering a high risk and a low risk according to PRISMA criteria. In conclusion, the results of this meta-analysis highlight a positive trend of probiotics supplementation on the amelioration of anthropometric measures of overweight and obese patients with related metabolic diseases. However, further research is needed before recommending the use of probiotics as a therapeutic strategy for these patients. The focus of the future research should be to evaluate the efficacy of different probiotic strains, the quantities to be administered, and the duration of the intervention.

Introduction: Non-syndromic hereditary hearing loss is characterized by extreme genetic heterogeneity. So far, more than 100 pathogenic or likely pathogenic variants in TMC1 gene have been reported in patients with autosomal recessive hearing loss (HL) DFNB7/11. The prevailing auditory phenotype of individuals with DFNB7/11 is congenital, profound, bilateral HL, but the functional outcome after cochlear implantation (CI) described in the literature is variable. The objective of this work is to evaluate the auditory outcome after CI in pediatric patients with DFNB7/11, born to non-consanguineous parents., Methods: A retrospective analysis of genetic and audiological data of DFNB7/11 patients followed up in a single Italian otolaryngology clinic was performed. Cases with biallelic pathogenic variants in TMC1 were selected from the cohort of children with non-syndromic hearing loss who had undergone CI and had been molecularly characterized by multigene panel testing. All patients underwent extensive audiological assessment, and the auditory outcome after CI was evaluated., Results: DFNB7/11 was diagnosed in a total of 3 patients from 2 non-consanguineous families; a novel disease-causing variant in TMC1 was detected [c.962G>A p.(Trp321*)]. All the affected children showed the typical DFNB7/11 phenotype characterized by prelingual, severe-to-profound HL. The patients showed an excellent functional outcome after CI; speech perception, nonverbal cognition, and speech performance were comparable to those of patients with DFNB1 deafness., Discussion/conclusion: Our results do not support the variable auditory outcome reported in the literature, which may be affected by several social and environmental factors and by the genetic background., (© 2020 S. Karger AG, Basel.)

Sarcopenia is defined as a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength and it is diagnosed by measurements of muscle mass, muscle strength, and physical performance. Sarcopenia affects quality of life and is associated with several adverse health effects. Muscle decline is aggravated by a sedentary lifestyle and can be prevented through proper nutrition, together with adequate physical activity. Fish contains biologically active compounds, such as omega-3 polyunsaturated fatty acids, proteins, vitamin D, magnesium, and carnitine, which are able to intervene positively on muscle metabolism. This narrative literature review was performed to evaluate evidence regarding the actual benefit of fish consumption in the prevention of sarcopenia and the positive action on the muscle mass of the biological compounds present in fish. The results demonstrated that fish consumption has a protective and anti-inflammatory function on skeletal muscle and that its biologically active compounds help to maintain good muscle performance, preventing sarcopenia. Considering the nutritional and health benefits, elderly with sarcopenia should consume at least three servings per week of fish in order to have a minimum intake of 4-4.59 g daily of omega 3, and reaching the 50% RDA in Vitamin E and D. High biological value of proteins in 150 g of fish and its high available magnesium (20% of RDA in 150 g of fish) are an added value that could suggest fish as a "functional food" in order to prevent and treat sarcopenia., Competing Interests: The authors declare no conflicts of interest.

Background: Chromosomal microarray analysis (CMA) is nowadays widely used in the diagnostic path of patients with clinical phenotypes. However, there is no ascertained evidence to date on how to assemble single/combined clinical categories of developmental phenotypic findings to improve the array-based detection rate., Methods: The Italian Society of Human Genetics coordinated a retrospective study which included CMA results of 5,110 Italian patients referred to 17 genetics laboratories for variable combined clinical phenotypes., Results: Non-polymorphic copy number variants (CNVs) were identified in 1512 patients (30%) and 615 (32%) present in 552 patients (11%) were classified as pathogenic. CNVs were analysed according to type, size, inheritance pattern, distribution among chromosomes, and association to known syndromes. In addition, the evaluation of the detection rate of clinical subgroups of patients allowed to associate dysmorphisms and/or congenital malformations combined with any other single clinical sign to an increased detection rate, whereas non-syndromic neurodevelopmental signs and non-syndromic congenital malformations to a decreased detection rate., Conclusions: Our retrospective study resulted in confirming the high detection rate of CMA and indicated new clinical markers useful to optimize their inclusion in the diagnostic and rehabilitative path of patients with developmental phenotypes., (© 2019 The Authors. Molecular Genetics & Genomic Medicine published by Wiley Periodicals, Inc.)

The current study developed an innovative Pemulen® TR2 hydrogel containing silibinin-loaded pomegranate oil-based nanocapsules (HP-NC SB) intending cutaneous application. The formulation anti-inflammatory activity in an in vivo model and biometric studies on the skin of healthy volunteers were also performed. The nanocapsules were prepared using the interfacial deposition of preformed polymer technique and the hydrogels were obtained by thickening of nanocapsules suspension with Pemulen® TR2. Formulations with free compound, vehicle and blank nanocapsules were also produced. The hydrogels were evaluated concerning pH, silibinin content, particle size, spreadability profile, rheology, in vitro drug release, cutaneous permeation, bioadhesive potential and cutaneous biometry evaluation. Furthermore, a model of contact dermatitis croton oil-induced in mice was performed to evaluate the hydrogels anti-inflammatory potential. The formulations presented adequate characteristics for skin administration: particle within nanometric size, pH values in the acid range, silibinin content close theoretical values (1 mg/g) and non-Newtonian pseudoplastic behavior. Nano-based hydrogels showed high bioadhesive properties, increased silibinin in vitro release profile and its retention in the stratum corneum. The best anti-inflammatory effect was exhibited by HP-NC SB, which reduced both ear edema and inflammatory cells infiltration in comparison to the induced group. Furthermore, cutaneous biometric evaluation showed that formulations containing free or nanoencapsulated silibinin caused no modification in normal skin conditions (pH, tissue hydration, transepidermal water loss and erythema). In summary, the results demonstrated that the Pemulen® TR2 hydrogel containing NC SB was successfully developed, indicating its potential as an alternative treatment for irritant contact dermatitis., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Silibinin (SB) and pomegranate oil (PO) present therapeutic potential due to antioxidant activity, but the biological performance of both bioactives is limited by their low aqueous solubility. To overcome this issue, the aim of the present investigation was to develop nanocapsule suspensions with PO as oil core for SB encapsulation, as well as assess their toxicity in vitro and radical scavenging activity. The nanocapsule suspensions were prepared by interfacial deposition of preformed polymer method. SB-loaded PO-based nanocapsules (SBNC) showed an average diameter of 157 ± 3 nm, homogenous size distribution, zeta potential of -14.1 ± 1.7 mV, pH of 5.6 ± 0.4 and SB content close to 100%. Similar results were obtained for the unloaded formulation (PONC). The nanocapsules controlled SB release at least 10 times as compared with free SB in methanolic solution. The SBNC scavenging capacity in vitro was statistically higher than free SB (p < 0.05). Cell viability in monocytes and lymphocytes was kept around 100% in the treatments with SBNC and PONC, while the SB and the PO caused a decrease around 30% at 50 μM (SB) and 724 μg/mL (PO). Protein carbonyls and DNA damage were minimized by SB and PO nanoencapsulation. Lipid peroxidation occurred in nanocapsule treatments regardless of the SB presence, which may be attributed to PO acting as substrate in reaction. The free compounds also caused lipid peroxidation. The results show that SBNC and PONC presented adequate physicochemical characteristics and low toxicity against human blood cells. Thereby, this novel nanocarrier may be a promising formulation for therapeutic applications.

The present study shows the development of a topical formulation (hydrogel) containing silibinin-loaded pomegranate oil based nanocapsules suspension and its evaluation as an alternative for the treatment of cutaneous UVB radiation-induced damages. For this, an animal model of skin injury induced by UVB radiation was employed. Gellan gum was used as gel forming agent by its direct addition to nanocapsules suspension. The hydrogels showed adequate pH values (5.6-5.9) and a silibinin content close to the theoretical value (1mg/g). Through vertical Franz diffusion cells it was demonstrated that nanocapsules decreased the silibinin retention in the semisolid formulation. All formulations were effective in reducing mice ear edema and leukocyte infiltration induced by UVB radiation 24h after the treatments. After 48h, only the hydrogels containing nanocapsules or silibinin associated with pomegranate oil demonstrated anti-edematogenic effect, as well as the positive control (hydrogel containing silver sulfadiazine 1%). After 72h, the hydrogel containing unloaded pomegranate oil based nanocapsules still presented a small activity. In conclusion, the results of this investigation demonstrated the feasibility to prepare a semisolid formulation presenting performance comparable to the traditional therapeutic option for skin burns (silver sulfadiazine) and with prolonged in vivo anti-inflammatory activity compared to the non-nanoencapsulated compounds., (Copyright © 2017. Published by Elsevier B.V.)

In rheumatoid arthritis (RA), treatment response is generally assessed using standard clinical disease activity measures. However, ultrasound has become increasingly popular among rheumatologists to monitor disease activity and response. The purpose of this analysis of ECOgraphic evaluation for STaging ARthritis (ECOSTAR) study data was to determine how ultrasound affects clinicians' decisions about changing treatment in RA. ECOSTAR was an observational, cohort study conducted between March 2010 and December 2012 at nine clinical centers in Italy in RA patients being considered for treatment change. After clinical evaluation of each patient, patients underwent diagnostic ultrasound (US) investigations and each patient was given a total echography score using a combination of scores for joint effusion, synovial hypertrophy, and power Doppler. The US results were provided to the clinicians and the influence of US on the clinicians' treatment choices were recorded. Ninety-five patients screened for study inclusion had confirmed RA (mean age 53.9 years; mean disease duration 8.9 years). Therapy changes were made by clinicians according to the hand and wrist joint US scores: score 0 appeared to have no influence on clinicians' decision to modify treatment, scores >0-3 were associated with a numerically higher estimated probability of not changing therapy than changing therapy, and scores >3 had a greater influence on the clinician to modify therapy and an increased probability of the clinician changing therapy versus not changing therapy. Ultrasonography scores appear to influence treatment decisions in patients with RA, with clinicians appearing less likely to alter treatment regimens in patients with low ultrasound scores and more likely to change treatment regimens when higher scores are obtained. Further research is warranted.