Salvatore Fasola

Efficacy of Buffered Hypertonic Saline Nasal Irrigation for Nasal Symptoms in Children with Seasonal Allergic Rhinitis: A Randomized Controlled Trial.

Background: Saline nasal irrigation is labelled as an add-on treatment in patients with allergic rhinitis (AR). The primary aim of this study was to compare the efficacy of 21-day use of buffered hypertonic saline (BHS) versus normal saline solution (NSS) on reducing nasal symptoms in children with seasonal AR (SAR). Comparing their efficacy on nasal cytology counts (NCC), quality of life, and sleep quality was the secondary aim. Methods: In this 21-day, open-label, randomized controlled study, 36 SAR children (aged 6-13 years) with a Total 5 Symptom Score (T5SS) ≥5 received twice-daily BHS or NSS delivered through a nasal douche. Efficacy measures were least square mean changes (LSmc) in T5SS, NCC, Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), and Pittsburgh Sleep Quality Index (PSQI) scores. Results: BHS improved the T5SS total score to a greater extent than NSS (LSmc -6.45 vs. -5.45, p < 0.001). Concerning NCC, BHS significantly reduced the scores of neutrophils (LSmc -0.76, p = 0.004) and eosinophils (LSmc -0.46, p = 0.018), while NSS did not. Similarly, only BHS yielded a significant improvement in the PRQLQ score (LSmc -0.57, p = 0.009), whereas the improvement in PSQI score was comparable between the BHS (LSmc -0.77, p = 0.025) and NSS (LSmc -1.39, p < 0.001) groups. Overall, BHS was well tolerated. Conclusions: In children with SAR, BHS is effective in improving nasal symptoms and NCC, with an associated beneficial effect on quality of life.

Inferential tools in penalized logistic regression for small and sparse data: A comparative study.

This paper focuses on inferential tools in the logistic regression model fitted by the Firth penalized likelihood. In this context, the Likelihood Ratio statistic is often reported to be the preferred choice as compared to the ‘traditional’ Wald statistic. In this work, we consider and discuss a wider range of test statistics, including the robust Wald, the Score, and the recently proposed Gradient statistic. We compare all these asymptotically equivalent statistics in terms of interval estimation and hypothesis testing via simulation experiments and analyses of two real datasets. We find out that the Likelihood Ratio statistic does not appear the best inferential device in the Firth penalized logistic regression.

An open-safety study of dual antiviral therapy in real-world patients with chronic hepatitis C

Treatment of patients with chronic hepatitis C with alpha‐interferon and ribavirin usually produces adverse events within the first 3 months. We aimed to assess safety and predictors of discontinuation or dose modification of these drugs.

Direct and indirect effects of Growth Hormone Deficiency (GHD) on lung function in children: A mediation analysis

BACKGROUND Studies on pulmonary function tests (PFTs) in Growth Hormone Deficiency (GHD) children are lacking. The aims of this study were: (i) to investigate PFTs in GHD pre-pubertal children with respect to Controls, before starting Growth Hormone Therapy (GHT) (T0); (ii) to evaluate changes of PFTs in GHD vs Controls, after 1-year GHT (T1). For both aims the mediation analysis (MA) was applied to evaluate the extent to which the relationship between GHD and PFTs could be ascribed to a height-mediated (indirect) or a GH direct effect. METHODS 47 pre-pubertal GHD children (aged 5-14 years) underwent PFTs at T0 and T1. At T0, 47 healthy children matched for age and sex were enrolled as Controls. A MA was performed to assess the relationship between GHD and PFTs and height. Statistical analyses were performed using the statistical software R (https://cran.r-project.org/mirrors.html). A p-value <0.05 was considered significant. MEASUREMENTS AND MAIN RESULTS At T0, PFTs indices were significantly lower in GHD than in Controls. From T0 to T1 a significant improvement was found in PFTs. The percentages of the mediated effect on FVC, FEV1, FEF25-75% and TLC were <50% at T0, suggesting that the direct effect was prevalent. At T1, the percentages of the mediated effect for spirometry indices were ≥50%, indicating that the indirect (height-mediated) effect was the most relevant. CONCLUSIONS The study shows that pre-pubertal children with GHD have an impairment of lung function not exclusively attributable to the indirect (height-mediated) effect, but also to the direct GH action which is mitigated after 1-year of GHT.

Comparative effect of beclomethasone dipropionate and cetirizine on acoustic rhinometry parameters in children with perennial allergic rhinitis: a randomized controlled trial

BACKGROUND AND OBJECTIVES The effect of intranasal corticosteroids and oral antihistamines on acoustic rhinometry parameters has not been directly compared. The primary objective was to compare the effect of a 21-day course of treatment with nasal beclomethasone dipropionate (nBDP) with that of cetirizine (CTZ) on nasal patency measured using acoustic rhinometry in children with perennial allergic rhinitis (PAR). The secondary objective was to compare the effect of both drugs on nasal cytology, symptom severity, sleep quality, and quality of life. METHODS In this 21-day, open-label, randomized controlled study, 34 children with PAR (age 6-14 years) with a Total 5-Symptom Score (T5SS) ≥5 received nBDP 100 μg per nostril twice daily or CTZ 10 mg tablets once daily. The measures of effect were the least square mean change (LSmc) in nasal volume, minimal cross-sectional area (MCA), and nasal cytology, as well as the scores on the T5SS, Pittsburgh Sleep Quality Index (PSQI), and Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ). RESULTS After 21 days, nBDP improved nasal volume and MCA more than CTZ (LSmc, 2.21 cm3 vs 0.20 cm3 [P=.013]; and LSmc 0.63 cm2 vs 0.13 cm2 [P=.002], respectively). Compared with the CTZ group, a more marked improvement was found in the nBDP group with respect to eosinophil classes (LSmc, -1.10 vs -0.40; P=.031) and neutrophil classes (LSmc, -0.97 vs -0.17; P=.010), T5SS (LSmc, -5.63 vs -3.54; P=.008), PSQI (LSmc, -1.30 vs -0.19; P=.025), and PRQLQ total scores (LSmc, -1.15 vs -0.69; P=.031). CONCLUSIONS In children with PAR, nBDP is more effective than CTZ in improving nasal patency measured by acoustic rhinometry, with associated beneficial effects on nasal cytology, symptoms, sleep quality, and quality of life.

From research question to dissemination: how to design, analyse and present study results

Today, the term “study” is very frequently used in quite a broad sense: survey, clinical trial, analysis, research and other terms with deeply different meanings are often generally indicated as “studies”. A “study” can be generally defined as a process composed of several actions aimed to verify one or more hypotheses (objectives), with the ultimate goal of sharing the answers (results) with a target audience, in the form of a scientific paper, presentation or poster. The key for the success of a study lies in the careful design of all its different phases, from the statement of the objectives to the dissemination of the results http://ow.ly/5NbG30kHEnQ

Rapid systematic review shows that using a high-flow nasal cannula is inferior to nasal continuous positive airway pressure as first-line support in preterm neonates.

We reviewed using a high‐flow nasal cannula (HFNC) as first‐line support for preterm neonates with, or at risk of, respiratory distress.

Nasal budesonide efficacy for nasal nitric oxide and nasal obstruction in rhinitis

Nasal nitric oxide (nNO) is a noninvasive tool that may be helpful in evaluating the inflammatory status in the upper airways [1]. Previous studies report that nNO is elevated in children with Allergic Rhinitis (AR) [2], especially in perennial sensitized subjects [3], and that it may be affected by topical administration of intranasal steroids (INSs) [4]. This article is protected by copyright. All rights reserved.

New Flexible Probability Distributions for Ranking Data

Recently, several models have been proposed for analysing the ranks assigned by people to some object. These models summarize the liking feeling towards the object, possibly with respect to a set of explanatory variables. Some recent works have suggested the use of the Shifted Binomial and of the Inverse Hypergeometric distribution for modelling the approval rate, while mixture models have been considered for taking into account the uncertainty in the ranking process. We propose two new probability distributions, the Discrete Beta and the Shifted-Beta Binomial, which ensure much flexibility and allow the joint modelling of the scale (approval rate) and the shape (uncertainty) parameters of the rank distribution.