Pamela Di Giovanni

MF59®-Adjuvanted H5N1 Vaccine Induces Immunologic Memory and Heterotypic Antibody Responses in Non-Elderly and Elderly Adults

Background Pathogenic avian influenza virus (H5N1) has the potential to cause a major global pandemic in humans. Safe and effective vaccines that induce immunologic memory and broad heterotypic response are needed. Methods and Findings Healthy adults aged 18–60 and >60 years (n = 313 and n = 173, respectively) were randomized (1∶1) to receive two primary and one booster injection of 7.5 μg or 15 μg doses of a subunit MF59-adjuvanted H5N1 (A/Vietnam/1194/2004) (clade 1) vaccine. Safety was monitored until 6 months after booster. Immunogenicity was assessed by hemagglutination inhibition (HI), single radial hemolysis (SRH) and microneutralization assays (MN). Mild injection-site pain was the most common adverse reaction. No serious adverse events relating to the vaccine were reported. The humoral immune responses to 7.5 μg and 15 μg doses were comparable. The rates for seroprotection (HI>40; SRH>25mm2; MN ≥40) after the primary vaccination ranged 72–87%. Six months after primary vaccination with the 7.5 μg dose, 18% and 21% of non-elderly and elderly adults were seroprotected; rates increased to 90% and 84%, respectively, after the booster vaccination. In the 15 μg group, seroprotection rates among non-elderly and elderly adults increased from 25% and 62% after primary vaccination to 92% and 88% after booster vaccination, respectively. A heterologous immune response to the H5N1/turkey/Turkey/05 strain was elicited after second and booster vaccinations. Conclusions Both formulations of MF59-adjuvanted influenza H5N1 vaccine were well tolerated. The European Union requirement for licensure for pre-pandemic vaccines was met by the lower dose tested. The presence of cross-reactive antibodies to a clade 2 heterologous strain demonstrates that this vaccine may be appropriate for pre-pandemic programs. Trial Registration ClinicalTrials.gov NCT00311480

Are Postural Restrictions Necessary for Management of Posterior Canal Benign Paroxysmal Positional Vertigo

Objectives: An important component of management of benign paroxysmal positional vertigo (BPPV) has been the application of postural restrictions after use of a canalith repositioning maneuver (CRM) to prevent the return of otolithic debris into the posterior semicircular canal (PSC). This study was designed to explore the effectiveness of postural restrictions in patients with BPPV caused by otolithic debris in the PSC. Methods: Seventy-four adult patients with unilateral PSC BPPV were enrolled into this study. All patients were managed with a CRM — Either the modified Epley maneuver or the Semont maneuver. The patients were divided randomly into 2 groups: Group A, with postural restrictions, and group B, without postural restrictions. The statistical analysis was performed with χ2 tests and t-tests. Results: No patients in either group showed positional nystagmus in the posttreatment evaluation under infrared videonys-tagmoscopy. No patients had symptoms of vertigo after the therapy. The results of follow-up vestibular tests were normal in both groups. Conclusions: In our experience, postural restrictions do not enhance the beneficial effect of the CRMs. They do not seem to have any protective role and therefore should not be recommended as an adjunct to the treatment of PSC BPPV.

Cigarette smoking in young-adult workers: a cross-sectional analysis from Abruzzo, Italy

Background : The “Valentino” cross-sectional study is aimed at evaluating the prevalence and pattern of cigarette smoking according to occupational group in a representative sample of workers aged 18-35 years from Abruzzo, Italy. Methods : Randomly selected workers anonymously self-compiled a structured questionnaire containing validated items. Job type was coded according to the International Standard Classification of Occupations. Results : The sample consisted of 3989 workers. Current smoking prevalence was 45.9%, varying across occupational groups and ranged from 37.2% among clerical support workers, up to 57.1% among craft, agricultural and fishery sector workers. After controlling for several potential confounders using logistic regression, craft, agricultural, forestry and fishery workers (adjusted odds ratio 1.65; 95%confidence intervals 1.21-2.27), and call-center operators (1.91; 1.44-2.53) were significantly more likely to be current smokers than professionals and clerical or support workers. Interestingly, when alcohol and cannabis use were included in multivariate analysis, the association between smoking and gender was no longer significant. Conclusions : An independent association was found between specific occupational classes and tobacco smoking, suggesting occupation type should be considered in prioritizing subsets of populations towards which smoking cessation campaigns should be targeted first.

Comorbidities and Risk-Adjusted Maternal Outcomes: A Retrospective Study on Administrative Data

Abstract Objective: The aim of this study was the evaluation of maternal outcomes and of the associated risk factors occurred in Abruzzo region, Italy, from 2009 to 2013. Methods: The study considered all the deliveries performed from 2009 to 2013 in Abruzzo region, Italy. Data were collected from all hospital discharge records. Univariate logistic regression analyses were performed to calculate crude odds ratios for each comorbidity. Stepwise multiple logistic regression models with backward selection were performed to identify predictors of the most frequent outcomes. Results: 57, 260 deliveries were analyzed. Severe complication occurred in 0.9% of all deliveries. The most frequent complications were “Severe Hemorrhage”, “Hysterectomy”, “Uterine rupture” and “Severe pre-eclampsia/eclampsia”. Malignant cancer (OR=55.76), coagulation disorders (OR=37.21), acute pulmonary disease (OR=29.75), placenta previa (OR=26.51), caesarean section (OR=3.24) and age (OR=1.08) were associated with a higher risk of hysterectomy. Anemia (OR=14.64), coagulation disorders (OR=10.31), cardiac disease (OR=12.74), pregnancy hypertension (OR=2.66), major pre-eclampsia/eclampsia (OR=2.78), placenta previa (OR=9.42) and multiple pregnancy (OR=3.69) were associated to severe hemorrhage. Thrombocytopenia (OR=26.04) and diabetes (OR=5.05) were associated to uterine rupture. Overweight or obesity (OR=25.88) and pregnancy cardiovascular disease (OR=25.85) were associated to pre-eclampsia. Conclusions: Maternal comorbidities are associated with increased risk of complications and may result in substantial costs to the health care system.

Trend in primary caesarean delivery: a five-year experience in ABRUZZO, ITALY

BackgroundPrimary caesarean section (PCS) rate is one of the main indicators of quality of care suggested by the Italian Government. Hospital rankings are usually based on it, therefore lower rates reflect more appropriate clinical practice. The aim of this study is to describe a five-year trend of PCS rate in Abruzzo region from 2009 to 2013 and to examine the medical indications for this mode of delivery.MethodsForty-five thousand one hundred forty-nine deliveries occurring from 2009 to 2013 were collected from all hospital discharge records (HDR) and analyzed. Among them we found 12,542 PCS. Odds ratios (ORs) with 95% confidence interval (95% CI) were estimated using logistic regression methods to evaluate the relationship between maternal risk factors and PCS in hospital over 1000 delivery/yrs.ResultsThe five-year PCS rate was 28.9%, with a decreasing trend from 31.4% in 2009 to 26.1% in 2013. Vasto Civil Hospital shows the lowest PCS rate (17.9% in 2013) among hospitals with a maximum of 1000 deliveries per year, while Pescara Civil Hospital shows the lowest PCS rate (25.4% in 2013) among hospitals with over 1000 deliveries per year. Women with major risk factors for cesarean section delivered more frequently in maternity units over 1000 delivery/yrs. Logistic regression analyses showed as diabetes, hypertension, twin pregnancy, fetal distress and preterm delivery were significant risk factors to deliver in unit over 1000 delivery/yrs. The most frequent (overall 66.6%) discharge diagnosis recorded in Hospital discharge records (HDR) is “Caesarean Delivery Without Indication”. 7.3% of PCS made in Abruzzo concerns women living in other Italian regions. 11.4% of PCS contains one of the indications to caesarean section (CS) that the Italian Guidelines consider appropriate.ConclusionsDuring the analyzed period, Abruzzo showed a decreasing, but still too high, PCS rate, compared to the limits fixed by the Italian Ministry of Health. Considering the limitation of this study, based on administrative data that are poor in clinical information, it is not possible to define the appropriateness of all caesarean sections.