Cesena, Italy
Cesena, Italy

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Leissinger C.,Tulane University | Gringeri A.,University of Milan | Antmen B.,Cukurova University | Berntorp E.,Skåne University Hospital | And 15 more authors.
New England Journal of Medicine | Year: 2011

BACKGROUND: Patients with severe hemophilia A and factor VIII inhibitors are at increased risk for serious bleeding complications and progression to end-stage joint disease. Effective strategies to prevent bleeding in such patients have not yet been established. METHODS: We enrolled patients with hemophilia A who were older than 2 years of age, had high-titer inhibitors, and used concentrates known as bypassing agents for bleeding in a prospective, randomized, crossover study comparing 6 months of anti-inhibitor coagulant complex (AICC), infused prophylactically at a target dose of 85 U per kilogram of body weight (±15%) on 3 nonconsecutive days per week, with 6 months of on-demand therapy (AICC at a target dose of 85 U per kilogram [±15%] used for bleeding episodes). The two treatment periods were separated by a 3-month washout period, during which patients received on-demand therapy for bleeding. The primary outcome was the number of bleeding episodes during each 6-month treatment period. RESULTS: Thirty-four patients underwent randomization; 26 patients completed both treatment periods and could be evaluated per protocol for the efficacy analysis. As compared with on-demand therapy, prophylaxis was associated with a 62% reduction in all bleeding episodes (P<0.001), a 61% reduction in hemarthroses (P<0.001), and a 72% reduction in target-joint bleeding (≥3 hemarthroses in a single joint during a 6-month treatment period) (P<0.001). Thirty-three randomly assigned patients received at least one infusion of the study drug and were evaluated for safety. One patient had an allergic reaction to the study drug. CONCLUSIONS: AICC prophylaxis at the dosage evaluated significantly and safely decreased the frequency of joint and other bleeding events in patients with severe hemophilia A and factor VIII inhibitors. (Funded by Baxter BioScience; Pro-FEIBA ClinicalTrials.gov number, NCT00221195.) Copyright © 2011 Massachusetts Medical Society.


PubMed | Santo Bono Hospital, Bufalini Hospital, Loma Linda University and University of Milan
Type: Journal Article | Journal: Journal of voice : official journal of the Voice Foundation | Year: 2016

The Childrens Voice Handicap Index-10 (CVHI-10) was introduced as a tool for self-assessment of childrens dysphonia. However, in the management of children with voice disorders, both parents and childrens perspectives play an important role. Because a self-tool including both a childrens and a parents version does not exist yet, the aim of the study was to develop and validate an assessment tool which parallels the CVHI-10 for parents to assess the level of voice handicap in their childs voice.Observational, prospective, cross-sectional study.To develop a CVHI-10 for parents, called CVHI-10-P, the CVHI-10 items were adapted to reflect parents responses about their child. Fifty-five children aged 7-12 years completed the CVHI-10, whereas their parents completed the CVHI-10-P. Each childs voice was also perceptually assessed by an otolaryngologist using the Grade Breathness Roughness (GRB) scale. Fifty-one of the 55 children underwent voice therapy (VT) and were assessed afterward using the GRB, CVHI-10, and CVHI-10-P.CVHI-10-P internal consistency was satisfactory (Cronbach alpha = .78). Correlation between CVHI-10-P and CVHI-10 was moderate (r = 0.37). CVHI-10-P total scores were lower than CVHI-10 scores in most of the cases. Single-item mean scores were always lower in CVHI-10-P compared with CVHI-10, with the exception of the only one item of the CVHI-10-P that directly involves the parents experience (item 10). Data gained from one tool are not directly related to the other, suggesting that these two tools appraise the childs voice handicap from different perspectives. The overall perceptual assessment scores of the 51 children after VT significantly improved. There was a statistically significant reduction of the total scores and for each item in CVHI-10 and CVHI-10-P after VT. These data support the adoption of the CVHI-10-P as an assessment tool and an outcome measure for management of childrens voice disorders.CVHI-10-P is a valid tool to appraise parents perspective of their childs voice disorder. The use of the CVHI-10 and the CVHI-10-P is recommended for objectively determining the level of voice handicap in children by parents and child.


Ricci-Maccarini A.,Bufalini Hospital | De Maio V.,Santobono Hospital | Murry T.,New York Medical College | Schindler A.,University of Milan
Journal of Voice | Year: 2013

Objectives/Hypothesis: To develop and validate the self-administered Voice Handicap Index-10 for children (CVHI-10) in Italian and evaluate its internal consistency and reliability in normal and disordered children's voices. Study Design: Cross-sectional survey study. Methods: CVHI-10 was developed after a series of individual interviews with 20 children, aged 8-14 years to discuss the phrasing and wording of the original VHI-10. Subsequently, 66 dysphonic children (group 1) provided input to test internal consistency, external validity, and clinical validity. The voices of group 1 children were rated using the Grade, Roughness, and Breathiness parameters of the Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS) scale. The test-retest results of 30 children (group 2) who successfully underwent voice treatment were also analyzed for test-retest reliability and responsiveness to treatment. Children of group 2 completed CVHI-10 twice, with an interval of 2 weeks. Additionally, 40 children without voice disorders (group 3) were included as a control group to obtain clinical validity. Each child included in the study completed CVHI-10 autonomously. Results: Internal consistency measured with the Cronbach α coefficient was.85; test-retest reliability was 0.84. CVHI-10 positively correlated with G (r = 0.62) and B (r = 0.34) parameters of the GRBAS scale on Spearman rho test. The mean CVHI-10 score for group 2 was 12.4 ± 2.8 before treatment and 3.6 ± 1.6 after treatment; the difference was significant using the Wilcoxon sign test (P = 0.0001). The difference between CVHI-10 scores in groups 1 and 3 was significant using the Mann-Whitney U test (P = 0.0001). Conclusions: CVHI-10 is easily administered, highly reproducible, exhibits good clinical validity, and responsiveness to treatment. © 2013 The Voice Foundation.


Sabbatani P.,Bufalini Hospital | Mantovan R.,Bufalini Hospital
International Journal of Cardiology | Year: 2013

Background For several years, the electrical external cardioversion (ECV) has entered into clinical practice without assistance of anesthesiology team. The aim of this study was to evaluate the efficacy and safety of sedation with midazolam in patients undergoing electrical cardioversion of atrial fibrillation (AF) by means of the evaluation of capnometry and pulmonary integrated index (IPI) using the Oridion Capnostream 20. Methods We studied 45 consecutive patients (pts) who underwent ECV of AF sedated with midazolam at mean dose of 5 mg bolus followed by another 5 mg in 2 minutes (min). Maximum dosage was 11 mg (average 8 ± 2 mg). After cardioversion we infused Anexate 0.5 mg bolus followed by 0.5 mg in 30 min. All pts were monitored with blood pressure, O 2 saturation, cardiac frequency and capnometers. Results EtCO 2 value at baseline was 37.14 ± 2.7, 35.02 ± 1.7 after induction of sedation and 36.59 ± 1.2 after awaking (p < 0.05 baseline to induction). IPI index was 9.58 ± 0.5 at basal 8.09 ± 0.63 at induction time and 9.02 ± 0.5 after awaking (p < 0.05 basal to induction, induction to awaking and basal to awaking but all data were in normal range). No pts had apnea or hypoxia but there was only one case of hypotension after shock, which lasted 2 min. Conclusions Conscious sedation with midazolam for electrical cardioversion of AF appears to be safe and effective because it does not affect adversely the respiratory parameters of pts as demonstrated by the analysis of EtCO2 and IPI index. © 2013 Elsevier Ireland Ltd.


Neri E.,University of Bologna | Agostini F.,University of Bologna | Gremigni P.,University of Bologna | Gobbi F.,Bufalini Hospital | And 3 more authors.
Journal of Investigative Dermatology | Year: 2012

To contribute to the application of the Childhood Atopic Dermatitis Impact Scale (CADIS), 135 Italian parents of children with atopic dermatitis (AD) aged birth to 6 years completed: CADIS, Infants Dermatitis Quality of Life Index (IDQOL) or Children's Dermatology Life Quality Index (CDLQI), and Dermatitis Family Impact 10-item questionnaire (DFI). A subsample of 66 caregivers completed the CADIS again, 48 hours later. Disease severity was measured with the Severity Scoring of Atopic Dermatitis (SCORAD) index. Exploratory factor analyses almost replicated the general factor structure of the original CADIS, established on a US sample. However, some differences emerged, probably due to cultural differences. A reduced version of the original CADIS was also obtained, based on the exploratory factor analyses, to facilitate use in clinical settings. The original and the shorter versions were tested for reliability: overall Cronbach's α and test-retest reliability for the child- and parent-related scales were acceptable. Regarding concurrent validity, estimates showed the CADIS to correlate adequately with SCORAD, IDQOL-CDLQI, and DFI. Multiple comparison tests for discriminant validity revealed significant differences between extreme groups based on AD severity for all five domains of CADIS. The original CADIS showed adequate validity and reliability in Italy as well, and the shorter version showed promising psychometric properties. © 2012 The Society for Investigative Dermatology.


Biasini A.,Bufalini Hospital
The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians | Year: 2012

Extremely-low-birth-weight infants (ELBW) should be given nutrients to enable them to grow at the same rate as foetuses of the same gestational age, and lean body components, particularly the brain, are dependent on protein intake. Fortified human milk remains the best food for these preterms. Two groups of preterm infants weighing 580-1250 g and with a gestational age of 23-32 weeks were fed with different protein intakes in fortified human/maternal milk (3.5 g kg(-1) per day and 4.8 g kg(-1) per day in the control and extra-protein groups, respectively). The tolerance, intrahospital growth, neurological outcome and anthropometric data until 9 months corrected age were evaluated. The extra-protein regime showed an intrahospital growth advantage (mostly in growth of head circumference, p 0.02, and length, p 0.04) only in the preterms weighing 580-980 g and aged 23-30 weeks. In the same preterms, the Griffith Development Mental Score at 3 months corrected age showed higher scores than in the control group (p 0.04). Growth during the post-discharge period for the experimental group at 9 months corrected age showed mean z-score values for length higher than those in the control group (p 0.04).


Piazza O.,University of Naples Federico II | Venditto A.,Bufalini Hospital | Tufano R.,University of Naples Federico II
Panminerva Medica | Year: 2011

Aneurysmal subarachnoid hemorrhage (SAH), in addition to the direct effects of the initial hemorrhage and secondary neurological complications, predisposes to medical complications. The proportion of deaths caused by non-neurological medical complications (cardiac, pulmonary, gastrointestinal, renal, hematological) equals that from neurological complications. In particular, pulmonary complications are responsible for 50% of all deaths from medical complications. Neurogenic pulmonary edema (NPE) is an increase of interstitial and alveolar fluid occurring as direct consequence of any acute central nervous system injury. Two different pathogenetic mechanisms of NPE have been hypothesized: i) hemodynamic (an increase of pulmonary vascular pressure due to an oc-adrenergic response produces hydrostatic edema) and ii) inflammatory mechanism (brain cytokines and chemokines determinates an increase in the permeability of pulmonary capillaries causing exudative edema). Recent studies postulate that both mechanisms may be implicated in the pathogenesis of NPE. Brain injury is known to determine increased levels of S100B, a Ca- binding protein, in cerebrospinal fluid and in blood. Moreover, amine precursor uptake and decarboxylation (APUD) cells located in the respiratory tract produce and release S100B. This protein may contribute to the pathogenesis of NPE binding RAGE receptors in alveolar epithelial type I pneumocytes and amplifying the immune and inflammatory response causing lung injury. S100B can be the link between the brain and the lung and may be among the multiple pathological pathways that determine the development of pulmonary edema after bleeding.


Michelucci R.,Bellaria Hospital | Pasini E.,Bellaria Hospital | Meletti S.,University of Modena and Reggio Emilia | Fallica E.,University of Ferrara | And 8 more authors.
Epilepsia | Year: 2013

Purpose: To present new information on the semiology and short-term evolution of seizures associated with primary brain tumors (PBTs) in a prospective study. Methods: This study is a section of the PERNO study - Project of Emilia Romagna Region on Neuro-Oncology, the main aim of which is to collect prospectively all cases of PBTs occurring in the Emilia-Romagna region, northeast Italy (3,983, 346 population) from January 2009 to December 2011, to allow epidemiologic, clinical, and biomolecular studies.The epilepsy section of the PERNO study included all the patients who experienced seizures, either as first symptom of the tumor or appearing during the course of the disease. Each patient was interviewed by the referring neurologist with a specific interest in epilepsy. The patients who entered the study were followed up with visits on a quarterly basis. Key Findings: We collected 100 cases with full clinical, neuroradiologic, and pathologic data. The majority (79%) had high grade PBTs (glioblastoma in 50 cases), whereas the remaining patients had low-grade gliomas, mostly localized in the frontal (60%), temporal (38%), and parietal (28%) lobes. Seizures were the first symptom of the tumor in 72 cases. Overall, the initial seizures were tonic-clonic (48%) (without clear initial focal signs in more than half of the patients), focal motor (26%), complex partial (10%), and somatosensitive (8%). The majority of cases (60%) had isolated seizures or a low seizure frequency at the onset of the disease, whereas a high seizure frequency or status epilepticus was observed in 18% and 12% of cases, respectively. Ninety-two patients underwent surgical removal of the tumor, which was either radical (38%) or partial (53%). Seven patients underwent only cerebral biopsy. In the 72 patients in whom seizures were the first symptom, the mean time to the surgical treatment was 174 days, with a significant difference between high grade (95 days) and low grade (481 days) gliomas. At the time of our first observation, the majority of patients (69%) had already undergone surgical removal, with a mean follow-up of 3 months after the procedure. Overall, 39 patients (56%) were seizure free after tumor removal. The good outcome did not depend on presurgical seizure frequency or tumor type, although there was a trend for better results with low-grade PBTs. Significance: These data provide evidence that seizures are strictly linked to the tumoral lesion: They are the initial symptom of the tumor, reflect the tumor location and type, are usually resistant to antiepileptic treatment, and may disappear after the treatment of the lesion.Wiley Periodicals, Inc. © 2013 International League Against Epilepsy.


Nardi G.,S Camillo Forlanini Hospital | Agostini V.,Bufalini Hospital | Rondinelli B.,S Camillo Forlanini Hospital | Russo E.,Bufalini Hospital | And 7 more authors.
Critical Care | Year: 2015

Introduction: Hemorrhage is the principal cause of death in the first few hours following severe injury. Coagulopathy is a frequent complication of critical bleeding. A network of Italian trauma centers recently developed a protocol to prevent and treat trauma-induced coagulopathy. A pre-post cohort multicenter study was conducted to assess the impact of the early coagulation support (ECS) protocol on blood products consumption, mortality and treatment costs. Methods: We prospectively collected data from all severely injured patients (Injury Severity Score (ISS) >15) admitted to two trauma centers in 2013 and compared these findings with the data for 2011. Patients transfused with at least 3 units of packed red blood cells (PRBCs) within 24hours of an accident were included in the study. In 2011, patients with significant hemorrhaging were treated with early administration of plasma with the aim of achieving a high (≥1:2) plasma-to-PRBC ratio. In 2013, the ECS protocol was the treatment strategy. Outcome data, blood product consumption and treatment costs were compared between the two periods. Results: The two groups were well matched for demographics, injury severity (ISS: 32.9 in 2011 versus 33.6 in 2013) and clinical and laboratory data on admission. In 2013, a 40% overall reduction in PRBCs was observed, together with a 65% reduction in plasma and a 52% reduction in platelets. Patients in the ECS group received fewer blood products: 6.51 units of PRBCs versus 8.14 units. Plasma transfusions decreased from 8.98 units to 4.21 units (P <0.05), and platelets fell from 4.14 units to 2.53 units (P <0.05). Mortality in 2013 was 13.5% versus 20% in 2011 (13 versus 26 hospital deaths, respectively) (nonsignificant). When costs for blood components, factors and point-of-care tests were compared, a €76,340 saving in 2013 versus 2011 (23%) was recorded. Conclusions: The introduction of the ECS protocol in two Italian trauma centers was associated with a marked reduction in blood product consumption, reaching statistical significance for plasma and platelets, and with a non-significant trend toward a reduction in early and 28-day mortality. The overall costs for transfusion and coagulation support (including point-of-care tests) decreased by 23% between 2011 and 2013. © 2015 Nardi et al.


PubMed | CNR Institute of Neuroscience, Bufalini Hospital and San Luca Hospital
Type: | Journal: Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography | Year: 2016

In patients with diabetes, the utility of diagnostic screening cardiac tests in subjects without clinical coronary artery disease remains controversial. The aim of this study was to assess the prognostic meaning of dual-imaging stress echocardiography (conventional wall motion analysis and Doppler-derived coronary flow velocity reserve [CFVR] of the left anterior descending coronary artery) in high-risk asymptomatic individuals with diabetes.This was a prospective analysis of 230 asymptomatic patients with diabetes (128 men; mean age, 669years) with no clinical evidence of coronary artery disease, no Q waves or deep negative waves on the electrocardiogram, and no wall motion abnormalities on resting echocardiography. Of these subjects, 147 (64%) had target organ damage and 83 (36%) had two or more associated cardiovascular risk factors. All patients underwent dipyridamole stress echocardiography with CFVR assessment of the left anterior descending coronary artery by transthoracic Doppler, and test results were entered into a database at the time of testing for a clinical and outcome follow-up (mean, 4.62.7years).Inducible ischemia and reduced CFVR (2) were detected in six and 52 patients, respectively. A total of 54 subjects (23%) had abnormal test results (ischemia or reduced CFVR). During follow-up, 39 major adverse cardiac events (MACEs) occurred: 22 hard events (18 deaths and four nonfatal myocardial infarctions) and 17 coronary revascularizations. The yearly incidence rates of hard events and MACEs in the entire study population were 2.1% and 3.6%, respectively. Abnormal test results were the only multivariate indicator of both hard events (hazard ratio, 3.69; 95% CI, 1.54-8.80) and MACEs (hazard ratio, 6.12; 95% CI, 3.22-11.62).Abnormal test results were obtained in one of four cases and were a strong and independent predictor of future hard events and MACEs.

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