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BACKGROUND Children with cerebral palsy (CP) often present a loss of effectiveness of the plantarflexors/knee-extensors couple that leads to crouch gait. When treating a child with crouch gait by means of ankle foot orthoses, preserving or restoring push off power is a key issue. AIM To compare carbon-fiber spring (Carbon Ankle Seven® [CAFO], Ottobock® HealthCare, Duderstadt, Germany) and hinged ankle-foot orthoses (HAFO) effectiveness in improving functionality and walking ability in children with diplegic CP and crouch gait. DESIGN Randomized crossover trial. SETTING Hospital center. POPULATION Ten children with diplegic CP and crouch gait, 5 males and 5 females, aged 11 (4) years. METHODS The gait of each child was evaluated by means of instrumental gait analysis with both CAFO and HAFO, in a randomized order and after a 4-week adaptation period. The primary outcome measure was the change in ankle power generation. As secondary outcome measures, knee joint kinematics, stride length, walking speed, Observational Gait Scale, and preferred orthosis were considered. RESULTS The median of the energy produced in stance was superior with CAFO (+2.2 J/kg, IQR 4.7, P=0.006), and the energy absorbed inferior (-3.3 J/kg, IQR 4.3, P=0.011). No statistically significant difference was found for any other parameter. Preference of the children was equally distributed between the two orthoses. CONCLUSIONS No evident superiority of CAFO with respect to HAFO was found in improving gait performance of children with CP and crouch gait. Nevertheless, the results suggest the possibility that CAFO permits an energy saving and reduction of the more compromising deficits. CLINICAL REHABILITATION IMPACT The final choice of the participants indicates that CAFOs are preferred by older and heavier children, but the preference does not correlate with the performance of the orthoses during gait.

ObjectivesTo describe the age- and sex-specific prevalence of SARS-CoV-2 disease (COVID-19) and its prognostic factors.DesignPopulation-based prospective cohort study on archive data.SettingPreventive services and hospital care in the province of Reggio Emilia, Northern Italy.ParticipantsAll 2653 symptomatic patients who tested positive for SARS-CoV-2 from February 27 to April 2, 2020 in the province of Reggio Emilia.Main outcome measuresHospitalization and death up to April 2, 2020.ResultsFemales had higher prevalence of infection than males below age 50 (2.61 vs. 1.84 ‰), but lower in older ages (16.49 vs. 20.86 ‰ over age 80). Case fatality rate reached 20.7% (22/106) in cases with more than 4 weeks follow up. After adjusting for age and comorbidities, men had a higher risk of hospitalization (hazard ratio (HR) 1.4 95% confidence interval (95% CI) 1.2 to 1.6) and of death (HR 1.6, 95% CI 1.2 to 2.1). Patients over age 80 compared to < age 50 had HR 7.1 (95% CI 5.4 to 9.3) and HR 27.8 (95% CI 12.5 to 61.7) for hospitalization and death, respectively. Immigrants had a higher risk of hospitalization (HR 1.3, 95% CI 0.99 to 1.81) than Italians and a similar risk of death. Risk of hospitalization and of death were higher in patients with heart failure (HR 1.6, 95% CI 1.2 to 2.1and HR 2.3, 95% CI 1.6 to 3.2, respectively), arrhythmia (HR 1.5, 95% CI 1.2 to 1.9 and HR 1.8, 95% CI 1.3 to 2.5, respectively), dementia (HR 1.2, 95% CI 0.9 to 1.8 and HR 1.8, 95% CI 1.1 to 2.8, respectively), ischemic heart disease (HR 1.3, 95% CI 1.0 to 1.7 and HR 1.7, 95% CI 1.2 to 2.5, respectively), diabetes (HR 1.5, 95% CI 1.3 to 1.9 and HR 1.6, 95% CI 1.1 to 2.2, respectively), and hypertensions(HR 1.4, 95% CI 1.2 to 2.6 and HR 1.6, 95% CI 1.2 to 2.1, respectively), while COPD increased the risk of hospitalization (HR 1.9, 95% CI 1.4 to 2.5) but not of death (HR 1.1, 95% CI 0.7 to 1.7). Previous use of ACE inhibitors has no effect on risk of death (HR 0.97, 95% CI 0.69 to 1.34)ConclusionsThe mechanisms underlying these associations are mostly unknown. A deeper understanding of the causal chain from infection, disease onset, and immune response to outcomes may explain how these prognostic factors act.

Omalizumab is frequently used as add-on treatment to inhaled corticosteroids (ICS) and long-acting β2-agonists in patients with suboptimal control of severe asthma. Patients with severe asthma will typically require chronic treatment, although due to the limited amount of data available there are still some concerns about the safety and efficacy of long-term therapy with omalizumab. Herein, in an extension of a previous 4-year study, we report disease-related outcomes of 8 patients with severe persistent allergic asthma who have been followed for a total of 9 years in a real-life setting. Both quality of life (QoL) (evaluated using the Juniper Asthma-Related QoL Questionnaire [AQLQ]) and forced expiratory volume in 1 second (FEV1) showed sustained improvement at 9 years. The median values of AQLQ and FEV1 at 4 years were 5.5 and 82.0% compared to 5.9 and 85.5%, respectively, at 9 years, which were all significantly increased from baseline. After 9 years, the mean annual number of severe exacerbations was 0.63 compared to 5 at baseline. There also appeared to be a trend toward use of a lower dose of ICS at longer follow-up times. After 9 years, there were no safety concerns for continued use of omalizumab, and no asthma-related hospitalizations or emergency department visits were documented over the last 5 years. The present analysis is the longest reported clinical follow-up of omalizumab. Long-term maintenance treatment with omalizumab for up to 9 years is associated with continued benefits in reducing symptoms, exacerbations, and medication burden without any safety concerns.

Purpose: Inpatients admitted to rehabilitation express needs not linked to disease causing hospitalization. This observational cross-sectional study identifies features and occupational needs of complex inpatients during rehabilitation, focusing on function and ability, regardless of diagnosis. Method: This study included sixteen adult inpatients with stroke, deemed complex according to Rehabilitation Complexity Scale-Extended, at admission to Rehabilitation ward (from July 2014 to February 2015). Patients with primary psychiatric disorders, language barriers, cognitive or severe communication deficits were excluded. Upon admission, a multidisciplinary team collected data on general health, independence in daily activities (Modified Barthel Index), fatigue (Fatigue Severity Scale), resistance to sitting and ability to perform instrumental activities (Instrumental Activities of Daily Living). The occupational therapist identified occupational needs according to Canadian Occupational Performance Measure. Results: Inpatients enrolled in this study were dependent in basic ADL, limited in instrumental ADL and easily fatigable. Their occupational needs related to self-care (75%) and, to a lesser extent, productivity (15%) and leisure (10%). According to inpatients, rehabilitation process should firstly address self-care needs, followed by productivity and leisure problems. Conclusions: Despite small sample size, this study described patterns of occupational needs in complex inpatients with stroke. These results will be implemented in client-centered rehabilitation programs to be tested in a phase-two trial. [NCT02173197]Implications for RehabilitationPriority occupational needs of complex inpatients with stroke during rehabilitation are focused on self-care area.Productivity and leisure problems also arise in early post-acute phase.Client-centered rehabilitation programs should firstly address self-care needs and, later on, they should also focus on the recovery of family and social roles. Priority occupational needs of complex inpatients with stroke during rehabilitation are focused on self-care area. Productivity and leisure problems also arise in early post-acute phase. Client-centered rehabilitation programs should firstly address self-care needs and, later on, they should also focus on the recovery of family and social roles.

PurposeMowat-Wilson syndrome (MWS) is a rare intellectual disability/multiple congenital anomalies syndrome caused by heterozygous mutation of the ZEB2 gene. It is generally underestimated because its rarity and phenotypic variability sometimes make it difficult to recognize. Here, we aimed to better delineate the phenotype, natural history, and genotype-phenotype correlations of MWS.MethodsIn a collaborative study, we analyzed clinical data for 87 patients with molecularly confirmed diagnosis. We described the prevalence of all clinical aspects, including attainment of neurodevelopmental milestones, and compared the data with the various types of underlying ZEB2 pathogenic variations.ResultsAll anthropometric, somatic, and behavioral features reported here outline a variable but highly consistent phenotype. By presenting the most comprehensive evaluation of MWS to date, we define its clinical evolution occurring with age and derive suggestions for patient management. Furthermore, we observe that its severity correlates with the kind of ZEB2 variation involved, ranging from ZEB2 locus deletions, associated with severe phenotypes, to rare nonmissense intragenic mutations predicted to preserve some ZEB2 protein functionality, accompanying milder clinical presentations.ConclusionKnowledge of the phenotypic spectrum of MWS and its correlation with the genotype will improve its detection rate and the prediction of its features, thus improving patient care.GENETICS in MEDICINE advance online publication, 4 January 2018; doi:10.1038/gim.2017.221. ispartof: Genetics in Medicine vol:20 issue:9 pages:965-975 ispartof: location:United States status: published

In spite of the hazard due to the radiation exposure, preparation of 90Y- and 177Lu-labelled radiopharmaceuticals is still mainly performed using manual procedures. In the present study the performance of a commercial automatic synthesizer based on disposable cassettes for the labelling of 177Lu- and 90Y-DOTA-conjugated biomolecules (namely, DOTATOC and PSMA-617) was evaluated and compared to a manual and a semiautomated approach. The dose exposure of the operators was evaluated as well. More than 300 clinical preparations of both 90Y- and 177Lu-labelled radiopharmaceuticals have been performed using the three different methods. The mean radiochemical yields for 90Y-DOTATOC were 96.2±4.9%, 90.3±5.6%, and 82.0±8.4%, while for 177Lu-DOTATOC they were 98.3% ± 0.6, 90.8% ± 8.3, and 83.1±5.7% when manual, semiautomated, and automated approaches were used, respectively. The mean doses on the whole hands for yttrium-90 preparations were 0.15±0.4 mSv/GBq, 0.04±0.1 mSv/GBq, and 0.11±0.3 mSv/GBq for manual, semiautomated, and automated synthesis, respectively, and for lutetium-177 preparations, they were 0.02±0.008 mSv/GBq, 0.01±0.03 mSv/GBq, and 0.01±0.02 mSv/GBq, respectively. In conclusion, the automated approach guaranteed reliable and reproducible preparations of pharmaceutical grade therapeutic radiopharmaceuticals in a decent RCY. The radiation exposure of the operators remained comparable to the manual approach mainly due to the fact that a dedicated shielding was still not available for the system.

Purpose To study with laser flare photometry the antiinflammatory effect of bromfenac added to a topical steroid versus a topical steroid alone in patients with pseudoexfoliation (PXF) syndrome after cataract surgery. Setting Ophthalmology Unit, Santa Maria Nuova Hospital, Reggio Emilia, Italy. Design Randomized clinical trial. Methods Patients with cataract and clinical signs of PXF were randomized to dexamethasone 0.1% and tobramycin 0.3% ophthalmic solution (Group 1) or with the adjunct of bromfenac ophthalmic solution 0.09% (Group 2). All patients were examined on the day of surgery (baseline) and postoperatively at 1, 3, 7, and 30 days. Laser flare photometry was used to quantify anterior chamber inflammation and optical coherence tomography to measure macular thickness. Results Sixty-two patients were included. Postoperatively, the mean flare was 31% lower in Group 2 than in Group 1 at 3 days (11.92 ph/msec ± 8.14 [SD] versus 17.13 ± 9.03 ph/msec; P = .025) and 43% lower at 7 days (10.77 ± 6.17 ph/msec versus 18.72 ± 12.37 ph/msec; P = .003). There were no significant differences in postoperative visual acuity, symptoms, or ocular pain between groups. The mean macular thickness 1 month after surgery was increased in Group 1 but not Group 2; the difference between groups was significant at 4 weeks ( P = .03). The incidence of intraretinal cysts was higher in Group 1 (n = 4) than in Group 2 (n = 0). Conclusion The addition of bromfenac to topical steroids after cataract surgery in eyes with PXF was associated with greater reductions in inflammation than steroids alone. Financial Disclosure None of the authors has a financial or proprietary interest in any material or method mentioned.

We explored whether influenza vaccination (IV) affects susceptibility to SARS-CoV-2 infection and clinical outcomes in COVID-19 patients in 17,608 residents of the Italian province of Reggio Emilia undergoing a SARS-CoV-2 test. Exposure to IV was ascertained and the strength of the association with SARS-CoV-2 positivity expressed with odds ratios (OR). Rates of hospitalisations and death in those found positive were assessed and hazard ratios (HR) were estimated. The prevalence of IV was 34.3% in the 4885 SARS-CoV-2 positive and 29.5% in the 12,723 negative subjects, but the adjusted OR indicated that vaccinated individuals had a lower probability of testing positive (OR = 0.89, 95% CI 0.80&ndash, 0.99). Among the 4885 positive individuals, 1676 had received IV. After adjusting for confounding factors, there was no association between IV and hospitalisation (1.00, 95% CI 0.84&ndash, 1.29) or death (HR = 1.14, 95% CI 0.95&ndash, 1.37). However, for patients age &ge, 65 vaccinated close to the SARS-CoV-2 outbreak, HRs were 0.66 (95% CI: 0.44&ndash, 0.98) and 0.70 (95% CI 0.50&ndash, 1.00), for hospitalisation and death, respectively. In this study, IV was associated with a lower probability of COVID-19 diagnosis. In COVID-19 patients, overall, IV did not affect outcomes, although a protective effect was observed for the elderly receiving IV almost in parallel with the SARS-CoV-2 outbreak. These findings provide reassurance in planning IV campaigns and underscore the need for exploring further their impact on COVID-19.

Background Bronchial thermoplasty (BT) is a non-pharmacological intervention for severe asthma whose mechanism of action is not completely explained by a reduction of airway smooth muscle (ASM). In this study we analyzed the effect of BT on nerve fibers and inflammatory components in the bronchial mucosa at 1 year. Methods Endobronchial biopsies were obtained from 12 subjects (mean age 47 ± 11.3 years, 50% male) with severe asthma. Biopsies were performed at baseline (T0) and after 1 (T1), 2 (T2) and 12 (T12) months post-BT, and studied with immunocytochemistry and microscopy methods. Clinical data including Asthma Quality of Life Questionnaire (AQLQ) and Asthma Control Questionnaire (ACQ) scores, exacerbations, hospitalizations, oral corticosteroids use were also collected at the same time points. Results A statistically significant reduction at T1, T2 and T12 of nerve fibers was observed in the submucosa and in ASM compared to T0. Among inflammatory cells, only CD68 showed significant changes at all time points. Improvement of all clinical outcomes was documented and persisted at the end of follow up. Conclusions A reduction of nerve fibers in epithelium and in ASM occurs earlier and persists at one year after BT. We propose that nerve ablation may contribute to mediate the beneficial effects of BT in severe asthma. Trial registration Registered on April 2, 2013 at ClinicalTrials.gov Identifier: NCT01839591.

Introduction. To determine effect size and feasibility of experimental occupational therapy (OT) intervention in addition to standard care in a population of complex patients undergoing rehabilitation in a hospital-home-based setting. Method. 40 complex patients admitted to the rehabilitation ward of the Local Health Authority-Research Institute of Reggio Emilia (Italy) were randomized in a parallel-group, open-label controlled trial. Experimental OT targeting occupational needs in the areas of self-care, productivity, and leisure was delivered by occupational therapists. Standard care consisted of task-oriented rehabilitation delivered by a multiprofessional team. Results. The experimental OT intervention was completed by 75% of patients assigned to this group. The average changes in the Canadian Occupational Performance Measure (COPM) performance score significantly and clinically favored experimental OT [−3,06 (−4.50; −1.61); delta>2 points, resp.]. Similar trends were detected for COPM satisfaction and independence in instrumental activities of daily living (ADL). At follow-up, level of social participation was higher for patients treated with experimental OT (p=0.043) than for controls. Conclusions. Experimental OT was feasible in complex patients in a hospital-home-based setting. It ameliorated both patients’ performance and satisfaction in carrying out relevant activities and improved independence in instrumental ADL. The trial is registered with ClinicalTrials.gov NCT02677766.

PURPOSE: Mowat-Wilson syndrome (MWS) is a genetic disease characterized by distinctive facial features, moderate to severe intellectual disability, and congenital malformations, including Hirschsprung disease, genital and eye anomalies, and congenital heart defects, caused by haploinsufficiency of the ZEB2 gene. To date, no characteristic pattern of brain dysmorphology in MWS has been defined.METHODS: Through brain magnetic resonance imaging (MRI) analysis, we delineated a neuroimaging phenotype in 54 MWS patients with a proven ZEB2 defect, compared it with the features identified in a thorough review of published cases, and evaluated genotype-phenotype correlations.RESULTS: Ninety-six percent of patients had abnormal MRI results. The most common features were anomalies of corpus callosum (79.6% of cases), hippocampal abnormalities (77.8%), enlargement of cerebral ventricles (68.5%), and white matter abnormalities (reduction of thickness 40.7%, localized signal alterations 22.2%). Other consistent findings were large basal ganglia, cortical, and cerebellar malformations. Most features were underrepresented in the literature. We also found ZEB2 variations leading to synthesis of a defective protein to be favorable for psychomotor development and some epilepsy features but also associated with corpus callosum agenesis.CONCLUSION: This study delineated the spectrum of brain anomalies in MWS and provided new insights into the role of ZEB2 in neurodevelopment.Genet Med advance online publication 10 November 2016Genetics in Medicine (2016); doi:10.1038/gim.2016.176.

Summary Background A series of studies has investigated epidemiological, clinical and genetic characteristics of patients with multiple primary melanoma (MPM). However, comparison of the clinical and dermoscopic features of MPM within a given individual has been described only in case reports. Objectives To describe the dermoscopic features of MPM for each given patient, and to evaluate the characteristics eventually associated with similar or dissimilar appearance. Methods From the databases of three skin-lesion clinics in the U.S.A., Italy and Spain we collected the dermoscopic images of melanomas in patients diagnosed with MPM. Results Among 58 patients with MPM, we found that 53% of patients had dermoscopically similar melanomas and 47% of patients had dermoscopically different melanomas. In older patients 59% of melanomas were dermoscopically similar vs. 47% in younger patients (P = 0·377). Similar thickness was associated with the occurrence of dermoscopically similar melanomas (19/30 cases, 63%; P = 0·039). Most (65%) of the synchronous lesions were similar, compared with 36% of nonsynchronous lesions (P = 0·029), and most (69%) of the melanomas on sun-damaged skin were similar, vs. 37% of melanomas on nonsun-damaged skin (P = 0·015; odds ratio 3·88, 95% confidence interval 1·11–13·98). The percentage of dermoscopically different melanomas was higher in patients with a family history of melanoma (67% vs. 48%). Conclusions MPMs in a given patient have almost the same chance of looking dermoscopically similar or different. However, a subset of elderly patients with sun-damaged skin may present multiple, similar, thin melanomas characterized by pigment-network and regression structures.

BACKGROUND: The aim of the study was to evaluate the adequacy of diagnosis and management of respiratory failure (RF) in COPD. METHODS: Retrospective analysis of the hospital discharge forms of COPD patients hospitalized for RF from January 2007 to June 2008. Using the clinical audit tool, the primary end point was the accuracy of RF diagnosis. The secondary end points were mortality, re-hospitalization rate, length of hospital stay, accuracy of long-term oxygen therapy (LTOT) prescription, and agreement of the treatments with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2008 guidelines. Statistical analysis used Pearson and Spearman correlation test and the Cohen kappa for degree of agreement. Differences in demographics and clinical parameters were analyzed with the chi-square test, t test, or the Fisher test, as appropriate. RESULTS: We studied 130 patients, 81 males (62%), mean ± SD age 76.6 ± 9.1 years. Arterial blood gas analysis (ABG) was performed in 118 patients (90.8%), and in 77 (81%) a PaO2 < 60 mm Hg was found at admission. Of these, 42 cases (54.5%) had no diagnosis of RF, despite a PaO2 < 60 mm Hg. In 18 (19%) PaO2 was ≥ 60 mm Hg; of these, 6 cases (33.3%) received an incorrect RF diagnosis. At discharge 8.1% of patients did not receive a diagnosis of RF, despite a compatible ABG. The highest mortality was found in the medicine departments (14.7%). The re-hospitalization rate at 90 days was 19.5%. Adherence of the treatment to the GOLD guidelines during hospitalization was confirmed in 75.8% of patients. In 41.1% of cases LTOT was prescribed at discharge; in 24 out of 27 cases PaO2 values were < 55 mm Hg. CONCLUSIONS: Agreement between diagnosis of RF and ABG values was found to be insufficient in about half the cases. Among secondary end points, adherence of the treatment to guidelines and LTOT prescription were, however, found to be good. Data showed significant inaccuracies in the management of RF at our institution.

Objectives: The aim of this study was to assess the stability of the effectiveness of omalizumab as add-on treatment in 11 patients with severe persistent allergic asthma followed for 4 years. Secondary outcomes were safety and economic impact, in terms of use of healthcare resources. Methods: This retrospective study was designed to analyse a series of patients with severe allergic asthma treated with omalizumab. Patients were initially enrolled as part of the CIGE025A2425 international multicentre clinical trial. At the end (week 32), 11 responsive patients went on to complete the study and continued omalizumab treatment until June 2010. The monitoring visits coincided with the timescales planned for administering the drug and for the follow up. To estimate the economic impact, the PRE–POST treatment comparison was obtained by comparing the annual pretreatment costs with an annual average of the 4-year posttreatment period costs Results: After 4 years, 81.8% of patients showed a good/excellent Global Evaluation of Treatment Effectiveness scale score and 81.2% showed an excellent increase (>1.5) in the Asthma Quality of Life Questionnaire score. The average forced expiratory volume in one second (FEV1) at 4 years was 75.3% compared with the predicted normal value for each patient, with a net increase ( p = 0.009) compared with baseline FEV1 values (58.6%). The frequency of serious exacerbations dropped by 94.7% compared with the pretreatment period, while mild–moderate exacerbations fell by 41.8%. A reduction in costs was observed for hospital admissions (97.3%), visits to emergency department (ED) (97.5%) and mild–moderate exacerbations (84%). The average cost reduction of concomitant drugs remained at 36%. Conclusions: This study confirms the effectiveness and reliability of omalizumab over the long term, while providing an excellent safety profile. The additional cost due the use of omalizumab was offset by the medium- and long-term savings associated with the reduction in hospital admissions and access to ED.

Disease activity assessment in large vessel vasculitis (LVV) is often challenging for physicians. In this study, we compared the assessment of disease activity based on inflammatory markers, clinical indices (Indian Takayasu Activity Score [ITAS] and the Kerr/National Institute of Health indices [Kerr/NIH]), and 18F-Fluorodesossiglucose (FGD) vascular uptake at positron emission tomography (Pet). We found that Pet results did not statistically correlate with the clinical indices ITAS and Kerr/NIH, because FDG uptake was increased (grade>2 on a 0-3 scale in at least one evaluated vascular segment) in many patients with inactive disease according to clinical and laboratory parameters (i.e., negative ITAS and Kerr/NIH indices as well as normal erythrocyte sedimentation rate (ESR) and C-reactive protein (PCR)). Similarly, interleukin- 6 and its soluble receptor did not statistically correlate with disease activity. In contrast, clinical indices showed a significant correlation between each other and with inflammatory markers (VES and PCR). These data suggest that while clinical indices and inflammatory markers may be useful to assess disease activity, Pet may be more sensitive.

Objective False-negative (FN) uptake of 18F-fluorodeoxyglucose (FDG) can be divided into those cases related to technological limitations of positron emission tomography (PET) and those related to inherent properties of neoplasms. Our goal was to clarify possible factors causing FN PET results in patients with solid-type pulmonary adenocarcinomas (PAs). Methods From January 2007 to December 2014, of the 255 patients with p-stage-1 non-small-cell lung cancer observed and treated (surgically) in our institution, we retrospectively reviewed the PET/computed tomography (CT) records, the clinical information, the preoperative thin-section CT images, and the pathological features [classified by the International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society (IASLC/ATS/ERS) subtyping criteria] of 94 consecutive solid-type p-stage-1 PAs. Univariable and multivariable logistic analyses were used to identify and weigh the independent predictors of the PET findings using the following variables: body weight, blood glucose level, tumour size, tumour location, and histological classification. Results There were 58 men and 36 women (mean age = 68.7 ± 8.9 years, range 42-85). Considering the maximum standardized uptake value (SUVmax) ≥ 2.5 as a 'PET-positive' result, 77 lesions (81.9%) proved PET positive and 17 lesions (18.1%), PET negative (with SUVmax

AIM: To determine the efficacy of our therapeutic strategy for Helicobacter pylori (H. pylori) eradication and to identify predictive factors for successful eradication. METHODS: From April 2006 to June 2010, we retrospectively assessed 2428 consecutive patients (1025 men, 1403 women; mean age 55 years, age range 18-92 years) with gastric histology positive for H. pylori infection referred to our unit for 13-C urea breath test (UBT), after first-line therapy with proton pump inhibitor (PPI) b.i.d. + amoxicillin 1 g b.i.d. + clarithromycin 500 mg b.i.d. for 7 d. Patients who were still positive to UBT were recommended a second-line therapy (PPI b.i.d. + amoxicillin 1 g b.i.d. + tinidazole 500 mg b.i.d. for 14 d). Third choice treatment was empirical with PPI b.i.d. + amoxicillin 1 g b.i.d. + levofloxacin 250 mg b.i.d. for 14 d. RESULTS: Out of 614 patients, still H. pylori-positive after first-line therapy, only 326 and 19 patients respectively rechecked their H. pylori status by UBT after the suggested second and third-line regimens. “Per protocol” eradication rates for first, second and third-line therapy were 74.7% (95% CI: 72.7%-76.4%), 85.3% (95% CI: 81.1%-89.1%) and 89.5% (95% CI: 74.9%-103%) respectively. The overall percentage of patients with H. pylori eradicated after two treatments was 97.8% (95% CI: 97.1%-98.4%), vs 99.9% (95% CI: 99.8%-100%) after three treatments. The study found that eradication therapy was most effective in patients with ulcer disease (P < 0.05, P = 0.028), especially in those with duodenal ulcer. Smoking habits did not significantly affect the eradication rate. CONCLUSION: First-line therapy with amoxicillin and clarithromycin produces an H. pylori eradication rate comparable or superior to other studies and second-line treatment can still be triple therapy with amoxicillin and tinidazole.

Background Systematic reviews have shown that, although well prepared, the Consensus Guidelines have failed to change clinical practice. In the healthcare district of Castelnovo né Monti (Reggio Emilia, Italy), it became necessary for the GPs and Clinical Pathologists to work together to jointly define laboratory profiles. Methods Observational study with two cycles of retrospective audit on test request forms, in a primary care setting. Objectives of the study were to develop pathology-specific laboratory profiles and to increase the number of provisional diagnoses on laboratory test request forms. A Multiprofessional Multidisciplinary Inter-hospital Work Team developed pathology-specific laboratory profiles for more effective test requesting. After 8 training sessions that used a combined strategy with multifaceted interventions, the 23 General Practitioners (GPs) in the trial district (Castelnovo nè Monti) tested the profiles; the 21 GPs in the Puianello district were the control group; all GPs in both districts participated in the trial. All laboratory tests for both healthcare districts are performed at the Laboratory located in the trial district. A baseline and a 1-year audit were performed in both districts on the GPs’ request forms. Results Seven pathology-specific laboratory profiles for outpatients were developed. In the year after the first audit cycle: 1) the number of tests requested in the trial district was distinctly lower than that in the previous year, with a decrease of about 5% (p Conclusions The first audit cycle showed a significant decrease in the number of tests ordered only in the trial district. The combined strategy used in this study improved the prescriptive compliance of most of the GPs involved. The presence of the clinical pathologist is seen as an added value.

BackgroundAccording to the hub-and-spoke model introduced in the Provincial Healthcare System of Reggio Emilia, early endometrial cancer is treated in peripheral low-volume hospitals (spokes) by general gynecologist, whereas more complex cancers are treated by gynecological oncologists at the main hospital (hub).ObjectiveTo guarantee a uniformly high standard of care to all patients with endometrial cancer treated in hub and spoke hospitals of Reggio Emilia Province.MethodsThe specialists of the 5 hospitals of Reggio Emilia Province instituted an inter hospital and multidisciplinary oncology group to write common and shared guidelines based on evidence-based medicine through the use of clinical audit. They valued the process indicators before and after guidelines introduction identifying the site of improvement and verifying the standard achievement.ResultsDiagnostic hysteroscopy use increased significantly from preguideline period, 53%, to postguideline period, 74%. Magnetic resonance use and accuracy increased significantly from preguideline to postguideline periods: 8.1% to 35.3% and 37.3% to 74.7%, respectively. Laparoscopy use increased from 1.6% (preguideline) to 18.6 (postguideline). Early surgical complications decreased from 16% (preguideline) to 9% (postguideline). Radiotherapy use increased from 14.% (preguideline) to 32.3% (postguideline).ConclusionIt is possible for a provincial oncology group to build an oncology network providing an improvement in the assistance of patients with endometrial cancer through the use of clinical audit. Clinical audit made it possible to obtain the full attendance of specialists of various disciplines involved in the treatment of endometrial cancer to optimize response time schematizing process.

Percutaneous laser ablation (PLA) is a proposed therapeutic procedure for the management of benign thyroid nodules. However, long-term results are unknown. The aim of this study was to evaluate retrospectively the safety and effects of PLA treatment in patients with benign nonfunctioning thyroid nodules in a 3-year follow-up.One hundred twenty-two patients (95 women and 27 men; age 52.2 ± 12.3 years) with benign cold thyroid solitary nodules or a dominant nodule within a normo-functioning multinodular goiter (volume range: 2.6-86.4 mL) underwent thermal Nd:YAG laser ablation of thyroid nodular tissue by 1-4 optical fibers positioned into the tissue by 21-gauge needles under ultrasound real-time assistance. The setting was an interventional suite and outpatient endocrine clinics in a community hospital in Italy. Nodule volume, ablation volume, side effects, serum thyroid-stimulating hormone (TSH), free triiodothyronine, free thyroxine (fT4), thyroglobulin (Tg), anti-Tg, anti-thyroperoxidase antibodies, symptoms, and cosmetic signs were recorded.Data are mean ± standard deviation. Energy delivered was 8522 ± 5365 J with an output power of 3.1 ± 0.5 W. Three years after PLA, nodule volume decreased from 23.1 ± 21.3 to 12.5 ± 18.8 mL (-47.8% ± 33.1% of initial volume, p ≤ 0.001). At day 1, TSH and fT4 values significantly changed (time 0 vs. day 1: TSH = 1.16 ± 1.06 vs. 0.62 ± 0.81 μU/mL, p ≤ 0.001; fT4 = 11.68 ± 1.88 vs. 13.20 ± 3.32 pg/mL, p ≤ 0.01) and normalized within 1 month. No change in free triiodothyronine, thyroperoxidase antibodies, and Tg antibodies values was observed. Symptoms improved in 89 patients (73.0%), were unchanged in 28 (22.9%), and worsened in 5 (4.1%). Cosmetic signs improved in 87 patients (71.3%), were unchanged in 29 (23.8%), and worsened in 6 (4.9%). In 11 patients (9%), nodules regrew above baseline. Two patients (1.6%) experienced delayed (12-24 hours) laryngeal dysfunction with vocal cord motility recovery after 6-10 weeks. Two patients (1.6%) became hypothyroid and two patients (1.6%) hyperthyroid after PLA.After 3 years, the PLA technique achieved shrinkage of about 50% of the initial volume in a wide size range of benign cold thyroid nodules, with an improvement in local symptoms and signs. Side effects and failures were few although not negligible. PLA may be a new option for the management of benign cold thyroid nodules. Long-term controlled studies are required to establish the eligibility of patients for routine PLA.

Background The purpose of this study was to identify risk factors for surgical extracervical approach in patients with substernal goiter. We used a novel classification system based on CT scan cross-sectional imaging (CSI) reconstruction. Methods Medical records of 4297 patients with thyroid disease operated on at our department were reviewed. A CSI classification system defined substernal goiter in the cranio-caudal dimension as: grade 1 (above aortic arch), grade 2 (level of aortic arch), and grade 3 (below aortic arch); in the anteroposterior dimension as type A (prevascular), type B (retrovascular-paratracheal), and type C (retrotracheal); in the latero-lateral dimension as: monolateral or bilateral. Results The prevalence of substernal goiter was 222 of 4297 cases (5.1%). Fifteen of 222 cases (6.7%) required an extracervical approach due to grade ≥2 and/or type C substernal goiter (14 of 15 cases). Ten of 15 patients had malignancy. Conclusion The CT-CSI classification system allows us to identify risk factors for extracervical surgical approach in substernal goiter. They are grade ≥2, type C substernal goiter, and malignancy. © 2010 Wiley Periodicals, Inc. Head Neck, 2011

Most fetal hematologic parameters show a significant relationship with gestational age: a linear increase is evident throughout gestation for several hematologic parameters. A few reports have described reference values for umbilical cord blood reticulocyte counts performed with automated hematology analyzers. Our aim was to use automated hematology analyzers (ADVIA 120; Siemens Healthcare Diagnostics) to establish reference intervals for reticulocyte parameters in cord blood from healthy newborns of 34 to 42 weeks of gestation. We also investigated whether differences in reticulocyte parameters exist between the sexes and between different weeks of gestation. We enrolled 98 healthy, appropriate for gestational age newborns. In term infants, the reticulocyte percentage, the absolute reticulocyte count, and the reticulocyte hemoglobin content decreased significantly as the gestational age increased, but the maturation subpopulations did not change significantly. We found no significant differences between the sexes. In conclusion, our results contribute to the establishment of reference intervals for cord blood from full-term newborns that are measured with an automated hematology analyzer.

The lengthening of life expectancy has led to more surgical procedures in elderly patients. The aim of this work was to determine whether age >70 years is a risk factor for pneumonectomy. All cases of pneumonectomy from January 1999 to December 2006 were retrospectively reviewed. The 40 patients aged > 70 years were compared with a group of 70 patients aged 40-68 years matched for sex, physical status, respiratory function, side of pneumonectomy, and pathologic stage. Postoperatively, significantly more older patients had atrial fibrillation (24% vs. 5.6%). There was a low incidence of respiratory complications in both groups, and reduced respiratory function did not increase respiratory morbidity. Thirty-day mortality was not significantly different (2.5% in older vs. 1.4% in younger patients), but long-term mortality rates evaluated at December 31, 2007 were 50% for those aged

The management of thyroid papillary microcarcinoma (PMC) is controversial. Total thyroidectomy, thyroid lobectomy/isthmectomy, and even no treatment have been proposed. We investigated the clinical course and prognostic factors for disease recurrence and distant metastasis in 445 patients with PMC.Data from 445 patients diagnosed with PMC in the period from 1978 to 2003 were reviewed and analyzed. Total thyroidectomy was performed in 404 patients and loboisthmusectomy in 41. Neck dissection took place in 226 patients (49.7%), with 166 of only the central compartment and 60 of both the central and lateral compartments. Radioiodine ((131)I) ablation treatment was given to 389 patients.Median tumor size was 7 mm (range 1-10 mm). PMC was multifocal in 156 cases (35%) and bilateral in 60 cases (13.5%). Extrathyroidal tumor extension (pT3) and neck lymph node metastasis (pN1) were present in 133 (30%) and 182 (40.9%) patients, respectively. Capsular invasion without extrathyroidal tumor extension was observed in 39 (8.7%) patients. Mean follow-up was 5.3 (range 1-26) years. Seventeen (3.8%) patients had recurrence or persistence of disease: neck recurrence (NR) in 12 (2.7%), distant metastasis (DM) in four (0.9%), NR + DM in one (0.2%). One patient (0.2%) died of the disease. Capsular invasion, extrathyroidal tumor extension (pT3), and neck lymph node metastasis at presentation (pN1) were the only independent risk factors for NR and/or DM occurrence (p0.05). Patients not showing these features, who were treated with loboisthmusectomy only, never experienced disease recurrence.Total thyroidectomy seems advisable in PMC with extrathyroidal extension and neck lymph node metastasis at presentation. Capsular invasion without extrathyroidal extension may suggest aggressive tumor behavior and require radical treatment.

Objective. To evaluate the impact of traditional cardiovascular risk factors, carotid atherosclerosis and the effect of anti-platelet/ anti-coagulant therapy on the occurrence of severe cranial ischaemic events (CIEs) in GCA. Methods. We identified 180 Reggio Emilia (Italy) residents with biopsy-proven GCA diagnosed between 1986 and 2005. We evaluated data on demographics, clinical features, laboratory investigations, cardiovascular risk factors, anti-platelet/anti-coagulant use and carotid atherosclerosis. Results. Systemic signs/symptoms were significantly less frequent (P ¼ 0.004) and ESR and C-reactive protein (CRP) values at diagnosis were significantly lower (P ¼ 0.03 and P ¼ 0.04, respectively) in patients with CIEs. The prevalence of hypertension and ischaemic heart disease was significantly higher in patients with CIEs than in those without (P ¼ 0.01 and P ¼ 0.006, respectively). Patients treated with antiplatelet/anti-coagulant therapy were significantly more likely to suffer CIEs than those without (P ¼ 0.03), while CIEs were significantly associated with ischaemic heart disease in this subset of patients (P ¼ 0.02). By multivariate logistic regression, we found that the best predictors for the development of severe CIEs included the absence of high (>5.38 mg/dl) CRP levels at diagnosis (OR ¼ 0.31, 95% CI 0.08, 1.20), the absence of systemic manifestations (OR ¼ 0.30, 95% CI 0.08, 1.08), the presence of hypertension (OR ¼ 7.77, 95% CI 0.83, 72.76), and a past history of ischaemic heart disease (OR ¼ 8.65, 95% CI 0.92, 80.95). Conclusions. In GCA, hypertension, a past history of ischaemic heart disease and a low inflammatory response are associated with a higher risk of developing severe CIEs.

Objectives The presence of circulating DNA in plasma of patients with malignant neoplasm has been a known fact for over 30 years. Since then, the concentration of free circulating plasma DNA has been studied as well as the genetic alterations and epigenetic alterations of tumour DNA of patients that suffer from various types of tumours. The analysis of circulating plasma DNA may be a useful marker to get an early diagnosis on malignant neoplasms. This study has been specifically designed to validate the quantification of circulating DNA in order to design a test useful for the early identification of non-small cell lung cancer patients and the monitoring of lung cancer progression. A second aim of this work is the sensibility and specificity evaluation of such method for future applications. Methods The quantity of plasma DNA was determined using quantitative Real-Time PCR with amplification of the human telomerase reverse transcriptase (hTERT) gene in 151 patients that suffer from lung cancer and 79 healthy controls. The performance of the test was evaluated with a ROC curve. The relationship between the DNA concentration and main demographic, clinical and pathological variables was examined with logistic regression models as well as multiple linear regression models. Results The concentration of circulating plasma DNA was about four times higher in patients with lung cancer with respect to the controls (12.8 vs 2.9 ng/mL). The area under the ROC curve was 0.79 (95% CI, 0.710–0.83). The concentration of circulating DNA proved to be an important risk factor for the presence of the illness and a prognostic index in the follow-up. Conclusions The use of quantitative Real-Time PCR revealed that higher values of circulating DNA can be found in patients with lung neoplasm compared to the healthy controls. This could have practical implications such as the use in screening programs and a possible prognostic significance in the follow-up.

The term interventional thyroidology refers to minimally invasive ultrasound-guided techniques to treat diseases of the endocrine neck, i.e., diseases of thyroid and parathyroid glands. Laser ablation (LA) and radiofrequency ablation (RFA) are two of these procedures used to destroy thyroid nodules and tumors using hyperthermia without surgical removal. Indications of LA and RFA technique for the treatment of endocrine neck diseases include symptomatic benign cold thyroid nodules, symptomatic thyroid cysts, autonomously functioning thyroid nodules, and recurrent thyroid cancer. Both thermal techniques have also been used for the treatment of parathyroid adenomas, but with several drawbacks and are no longer recommended. The advantages of in situ tumor ablation are reduced costs, the possibility of performing procedures on outpatients, the possibility of treating patients who are poor candidates for surgery due to age or comorbidity, and the possibility of treating patients who refuse surgery. LA and RFA are performed by endocrinologists, interventional radiologists, and surgeons.

Objective. To investigate potential associations of the PlA1/A2 polymorphism of the platelet glycoprotein IIIa (GPIIIa) gene with susceptibility to, and clinical expression of, giant cell arteritis (GCA). Methods. One hundred forty patients with biopsyproven GCA who were residents of Reggio Emilia, Italy, and 241 population-based healthy controls from the same geographic area were genotyped for the PlA1/A2 polymorphism of the platelet GPIIIa gene by molecular methods. The patients were divided into subgroups according to the presence or absence of polymyalgia rheumatica and cranial ischemic complications. The distribution of the PlA1/A2 genotype was investigated, and odds ratios (ORs) and 95% confidence intervals (95% CIs) were calculated. Results. The distribution of the PlA1/A2 genotype differed significantly between GCA patients with and those without visual loss caused by anterior ischemic optic neuritis (P 0.016, corrected P [Pcorr] 0.048). The PlA2 allele was found significantly more frequently in GCA patients with anterior ischemic optic neuritis than in those without anterior ischemic optic neuritis (P 0.023, Pcorr 0.046, OR 2.4 [95% CI 1.2–4.8]). Homozygosity for the PlA2 allele was significantly more frequent among GCA patients with anterior ischemic optic neuritis than among those without (P 0.019, Pcorr 0.038, OR 7.1 [95% CI 1.64–30.6]). Cranial ischemic complications occurred in 8 of 19 patients (42.1%) receiving antiplatelet therapy, compared with 22 of 118 patients (18.6%) not receiving such therapy (P 0.03, OR 3.2 [95% CI 1.1–8.8]). Conclusion. Our findings show that A2/A2 homozygosity is associated with an increased risk of visual loss due to anterior ischemic optic neuritis in GCA patients. Antiplatelet therapy, however, was not effective in reducing the risk of ischemic events in this population of GCA patients.

Background and goals Extracorporeal shockwave lithotripsy (ESWL) is an established treatment of irretrievable biliary and pancreatic stones, but the cost of the shockwave generators limits its widespread use. We revised data about the effectiveness of our treatment for refractory stones using a transportable shockwave generator. Study We retrospectively evaluated the short and medium-term outcomes of patients who underwent ESWL using a transportable electromagnetic shockwave generator between 1998 and 2003 at our unit, for the treatment of irretrievable bile duct or pancreatic duct stones. All patients received intravenous conscious sedation and antibiotic prophylaxis. Results Complete stone clearance was achieved in 70/82 patients (85.4%), in 66 of the patients (94.2%) with 1 session of ESWL. Despite the insertion of a stent in the bile duct, 2 patients had moderate cholangitis, while they waited for the next ESWL session. We did not record any moderate-severe complication of ESWL, but 2 patients underwent surgery owing to perforation/bleeding during endoscopic removal of residual fragments. A symptomatic recurrence of stones was recorded in 10/69 (14.5%) patients, who had been previously cleared and whose follow-up data (median follow-up 29 mo; range 7 to 66) were available. Conclusions We obtained satisfactory stone clearance by using a transportable shockwave generator. Most patients required 1 session. Our experience confirmed the safety of the treatment, even though patients may experience cholangitis while awaiting definitive treatment. The use of a transportable ESWL generator may be a valuable option in centers, while ensuring a sufficient proficiency in biliary endoscopy.

Background 18F-Fluorodeoxyglucose (FDG) positron emission tomography (PET)/computerized tomography (CT) [PET/CT] has been proposed as a useful tool to diagnose and monitor activity of large vessel vasculitis (LVV), but its precise role remains debated. Objectives To determine the value of PET-CT in the assessment of disease activity in LVV. To this end, PET/CT findings were correlated with clinical indices including ITAS (Indian Takayasu activity score) and Kerr/National Institute of Health (Kerr/NIH), serum acute-phase reactants (ESR, C-reactive protein [CRP]) levels as well as interleukin-6 (IL-6) and the soluble IL-6 receptor (sIL-6R). Methods 78 patients with LVV (giant cell arteritis, Takayasu arteritis or idiopatic aortitis) underwent a total of 215 PET/CT scans. PET/CT scans were reviewed by a nuclear medicine physician without knowledge of clinical information. Vascular uptake was graded using a 4-point semiquantitative scale. PET/CT scans were considered negative if vascular FDG uptake was grade 0-1, moderately positive if vascular uptake was grade 2, and markedly positive if vascular uptake was grade 3 in at least one vessel. ITAS, Kerr/NIH scores, ESR, CRP, IL-6 and sIL-6R values were obtained within 20 days of PET/CT scans. Results 43% of 215 PET-CT were negative, 31% were moderately positive, and 26% were markedly positive. We found a significant association between the intensity of the uptake and both ESR and CRP levels. Significantly higher ESR values were observed in the patients with markedly positive PET/CT (49.4 ± 36.5 mm/1st h) compared with those with moderately positive (27± 21 mm/1st h, p = 0.0001) and inactive scans ( 22.7 ± 15.9 mm/1st h, p=0.0001), respectively. CRP levels were 0.8±1.0 mg/dL in patients with inactive scans, 1.3± 2.2 mg/dL in patients with moderately positive (p=0.001) and 3.0 ± 3.6 in patients with markedly positive scans (p = 0.0001). Significantly higher levels of IL-6 were measures in patients with markedly positive scans (10.0 ± 8.9 pg/ml) compared to those with inactive scans (8.1±18.5 pg/ml, p=0.013). No association was found between sIL-6R levels and intensity of vascular FDG uptake. There was a significant association between the intensity of vascular FDG uptake and both ITAS and Kerr/NIH scores. Patients with markedly positive scans had more frequently (50%) active vasculitis according to the ITAS compared with those with moderately active (31.7%) and inactive scans (28.1%) (p=0.003). Likewise, vasculitis was judged to be active according to the Kerr/NIH index in 50% of patients with markedly positive scans, 22% of those with moderately positive scans, and 14.6% with inactive scans (p=0.0001). Conclusions Our findings show a strong association between vascular FDG uptake and clinical activity and traditional inflammatory markers. A weaker association was found between vascular FDG uptake and IL-6 levels. These data suggest that PET/CT may be a useful tool for evaluating disease activity in patients with LVV. Disclosure of Interest None Declared

Background: Epithelial ovarian cancer (EOC) is the most lethal gynecological cancer. Several hospitals throughout the region provide primary treatment for these patients and it is well know that treatment quality is correlated to the hospital that delivers. The aim of this study was to investigate the management and treatment of EOC in a Region of the North Italy (Emilia-Romagna, Italy). Methods. A multidisciplinary group made up of 11 physicians and 3 biostatisticians was formed in 2009 to perform clinical audits in order to identify quality indicators and to develop Region-wide workup in accordance with the principles of evidence-based medicine (EBM). The rationale was that, by setting up an oncogynecology network so as to achieve the best clinical practice, critical points would decrease or even be eliminated. Analysis of cases was based on the review of the medical records. Results: 614 EOC patients treated between 2007 and 2008 were identified. We found only 2 high-volume hospitals (≥ 21 patients/year), 3 medium-volume hospitals (11-20 operated patients/year), and 7 low-volume hospitals (≤ 10 operated patients /year). Only 222 patients (76.3%) had a histological diagnosis, FIGO surgical staging was reported only in 206 patients (70.9%) but not all standard surgical procedures were always performed, residual disease were not reported in all patients. No standard number of neoadjuvant chemotherapy cycles was observed. Conclusions: The differences in terms of treatments provided led the multidisciplinary group to identify reference centers, to promote centralization, to ensure uniform and adequate treatment to patients treated in regional centers and to promote a new audit involving all regional hospitals to a complete review of the all the EOC patients. © 2013 Mandato et al.; licensee BioMed Central Ltd.