Olfactory dysfunction in patients with type 2 diabetes mellitus.

BACKGROUND: diabetic complications and olfactory dysfunction (OD) in patients with type 2 diabetes mellitus (T2DM) seem related. This study aims to evaluate the prevalence of OD in T2DM patients and to analyze its relationship with diabetic complications. METHODS: 130 T2DM patients and 100 comparable controls were enrolled. Olfaction was evaluated using the Extended Smell Test (TDI) and the Italian brief Questionnaire of Olfactory Disorders - Brief-IT-QOD. T2DM patients were divided into: "Group 1", patients with no complications, and "Group 2", patients with at least one diabetic complication. Non-parametric tests were used. Machine learning algorithms were applied to explore which variables were most important in predicting the presence of OD in T2DM. RESULTS: The prevalence of OD was significantly higher in Group 2 than in controls (71.4% vs 30%) and in Group 1 (71.4% vs 43.3%). However, when comparing the TDI scores between Group 1 and 2 the only significant difference was found for the discrimination scale and not for the identification and threshold scales. Brief-IT-QOD scores were significantly higher in Group 2 than in controls. The Random Forest and variable importance algorithms highlighted the relevance of LDL, glycated hemoglobin, type of complication (macrovascular) and age in determining OD in T2DM. The last three variables were included in a nomogram for the prediction of OD risk in T2DM. CONCLUSIONS: T2DM patients with diabetic complications are more frequently affected by OD. Poor glycemic control, LDL values, age and presence of macrovascular complications are the more important factors in determining OD in T2DM patients.

Effect of surgery, delivery device and head position on sinus irrigant penetration in a cadaver model.

OBJECTIVE: The extent of surgery, the type of device used and head position may influence nasal irrigation. The aim of this study was to determine the effectiveness of topical irrigant delivery to the paranasal sinuses according to these factors. METHOD: Four cadaveric heads underwent four stepwise endoscopic dissections. Irrigations were evaluated after every stage using different delivery devices (squeeze-bottle, gravity-dependent device and syringe) in two head positions (nose-to-sink and vertex down). Irrigant penetration into each sinus was estimated using a four-point scale. RESULTS: A significant positive effect of surgery was demonstrated for each sinus as well as for the delivery device. High-volume irrigant devices are more effective, and the head position plays a significant role in irrigant distribution to the frontal sinus. CONCLUSION: This study further confirms the efficacy of high-volume irrigant devices. A vertex down position during the irrigation could improve delivery to the frontal sinus, and the widening of the ostia increases irrigant access to the sinuses.

Vocal Tract Discomfort and Dysphonia in Patients Undergoing Empiric Therapeutic Trial with Proton Pump Inhibitor for Suspected Laryngopharyngeal Reflux.

INTRODUCTION: the aim of this study was to evaluate the correlation among dysphonic and vocal tract discomfort symptoms in patients who underwent empiric therapeutic trial with proton pump inhibitor (PPI) for a suspected laryngopharyngeal reflux (LPR). MATERIALS AND METHODS: A total of 34 patients with suspected LPR were enrolled in this study. All of them were evaluated using the reflux finding score, the reflux symptom Index (RSI), the vocal tract discomfort scale (VTDS), and the voice symptom scale (VoiSS) before and after the PPI treatment. RESULTS: A significant difference was found between pretreatment and posttreatment reflux finding score, RSI, VTDS, and VoiSS scores. Significant correlations among RSI, VTDS, and VoiSS before the PPI treatment were found. CONCLUSION: PPI treatment determined a significant improvement of symptoms related to dysphonia and vocal tract discomfort in patients with suspected LPR, in addition, significant correlations among the RSI, VTDS, and VoiSS scores were demonstrated thus suggesting that LPR might influence the response of questionnaires not specifically developed in order to assess the complains in LPR patient.

Double-blind, randomised controlled trial on the efficacy of saline nasal irrigation with sodium hyaluronate after endoscopic sinus surgery.

OBJECTIVE: There is a growing interest in sodium hyaluronate for the clinical management of patients who undergo functional endoscopic sinus surgery for chronic rhinosinusitis, because of the mucosal regenerative properties of this macromolecule. However, its role in post-operative care is still debated. This study aimed to evaluate the effect of sodium hyaluronate administered via nasal irrigation with saline, in the post-operative period, after functional endoscopic sinus surgery. METHODS: A multicentric, prospective, randomised, double-blind, parallel group study was conducted on 56 consecutive patients who underwent functional endoscopic sinus surgery for chronic rhinosinusitis without polyps. Group 1 received the standard therapy of normal saline; group 2 received saline plus sodium hyaluronate. RESULTS: Both objective and subjective measurements, in terms of endoscopic appearance and patient-reported satisfaction, were significantly better in group 2 compared to group 1. CONCLUSION: Sodium hyaluronate may be a useful adjunct to nasal saline irrigation in the early post-operative period following functional endoscopic sinus surgery.

Efficacy of trans-nasal fiberendoscopic injection laryngoplasty with centrifuged autologous fat in the treatment of glottic insufficiency due to unilateral vocal fold paralysis.

SUMMARY: The objective of this work is to evaluate the safety, feasibility and efficacy of trans-nasal fiberendoscopic injection laryngoplasty (IL) with centrifuged autologous fat, performed under local anaesthesia, in the treatment of glottic insufficiency due to unilateral vocal fold paralysis (UVFP). It is a within-subject study with follow-up 1 week after phonosurgery and after 6 months. A total of 22 patients with chronic dysphonia caused by glottic insufficiency due to UVFP were enrolled. Each patient underwent trans-nasal IL with centrifuged autologous fat through flexible operative endoscope under local anaesthesia and was evaluated before and twice (1 week and 6 months) after phonosurgery, using a multidimensional set of investigations. The assessment protocol included videolaryngostroboscopy, perceptual evaluation of dysphonia, maximum phonation time and patient's self-assessment on voice-related quality of life (QOL) with the Voice Handicap Index-10 and the comparative self-assessment on vocal fatigue and voice quality pre-post treatment. Trans-nasal IL with centrifuged autologous fat was performed in all 22 patients and there were no complications in any case. Significant improvements in videolaryngostroboscopic findings, perceptual evaluation of dysphonia, maximum phonation time and QoL self-assessment were reported after 1 week and were maintained at 6 months. In one patient, the result after 6 months was not satisfactory and this patient then underwent a medialization laryngoplasty (thyroplasty type I) with satisfactory long-term results. In conclusion, trans-nasal fiberendoscopic IL with centrifuged autologous fat seems to be a safe, feasible and efficacious phonosurgical procedure for treatment of glottic insufficiency due to unilateral vocal fold paralysis.

Horizontal lateral lamella as a risk factor for iatrogenic cerebrospinal fluid leak. Clinical retrospective evaluation of 24 cases.

BACKGROUND: Several authors highlighted the limitations of the Keros classification system in predicting intracranial entry risk. Recently, our group proposed a new classification system based on the angle formed between the lateral lamella of the cribriform plate (LLCP) and the continuation of an horizontal plane passing through the cribriform plate (Gera classification). The aim of this study was to analyze whether the risk of iatrogenic cerebrospinal fluid leak (CSF-L) was better predicted by Keros or Gera classification. METHODOLOGY: The pre-operative CT scans of 24 patients (CSF-L group) who suffered from iatrogenic CSF-L during endoscopic sinus surgery (ESS) were compared to those obtained from a group of 100 patients who underwent uneventful ESS (control group). The skull base measurements as well as the distribution of Keros and Gera classes in the 2 groups were analyzed. RESULTS: No difference in the distribution of Keros classes or in the depth of the cribriform plate between CSF-L and control group were demonstrated. On the contrary, significant differences in the distribution of Gera classes and in the degree of the angle formed by the LLCP and the continuation of the horizontal plane passing through the cribriform plate were found. In particular, according to Gera classification system, 19 out of 24 patients in the CSF-L group were considered at risk for iatrogenic CSF-L. CONCLUSIONS: Gera classification system might be more sensitive to anatomical variations associated with CSF-L than the Keros one, further suggesting the application of the former during the preoperative CT scan evaluation.

Lateral lamella of the cribriform plate, a keystone landmark: proposal for a novel classification system.

BACKGROUND: The aim of this study is to propose a classification of the angle formed by the lateral lamella of the cribriform plate (LLCP) and the horizontal plane passing through the cribriform plate. In particular, the angle was classified into class I (over 80 degrees), class II (45 to 80 degrees, and class III (under 45 degrees) METHODOLOGY: A total of 190 computed tomography scans were retrospectively reviewed in order to obtain four sets of measurements. 1) depth of the cribriform, 2) angle, 3) length of the LLCP, 4) width of the fovea ethmoidalis. The relationship among these measurements were analyzed. RESULTS: The angle was significantly correlated with the depth of the cribriform and the length of the fovea, while it was negatively correlated with the length of the LLCP. Significant negative correlation was also found between the length of the LLCP and the width of the fovea. CONCLUSIONS: This angle classification is based on the theoretical risk of iatrogenic injuries, but it could be helpful also in clinical practice by providing indirect information on the thickness of the anterior skull base. As the angle decreases, in fact, the portion of the anterior skull base composed by the LLCP, increases.

Early prelingual auditory development in Italian infants and toddlers analysed through the Italian version of the Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS).

PURPOSE: To evaluate the reliability and validity of the Italian version of the Infant-Toddler Meaningful Auditory Integration Scale (I-IT-MAIS), and to assess the normal trajectory of early prelingual auditory (EPLAD) development from birth to 24 months in a group of normal-hearing Italian children using the I-IT-MAIS. METHODS: The study consisted of four phases: item generation, reliability analysis, assessment of the normal trajectory for EPLAD, and validity analysis. A group of 120 normal-hearing children and a group of 31 deaf children wearing hearing aids and on a waiting list for cochlear implantation were enrolled. All the parents completed the I-IT-MAIS. Sixty of them completed the I-IT-MAIS twice, 2 weeks apart, for test-retest reliability analysis. The I-IT-MAIS scores were used to assess the normal trajectory of EPLAD development from birth to 24 months in normal-hearing children. For criterion validity analysis, the I-IT-MAIS scores were correlated with production of infant scale evaluation (PRISE) scores in 60 normal-hearing children. For discriminant validity analysis, the I-IT-MAIS scores obtained in normal and deaf children were compared. RESULTS: Internal consistency of I-IT-MAIS was satisfactory as well as individual item reliability, test-retest reliability, and discriminant validity. EPLAD development in normal-hearing Italian-speaking children was evaluated. As far as the criterion validity of the I-IT-MAIS is concerned, a strong correlation between I-IT-MAIS and PRISE scores was found. CONCLUSION: I-IT-MAIS is reliable and valid. Its application is recommended for clinical practice and outcome research.

Dysphagia screening in subacute care settings using the Italian version of the Royal Brisbane and Women's Hospital (I-RBWH) dysphagia screening tool.

The large majority of the available dysphagia screening tools has been developed for the stroke population. Only few screening tools are suitable for heterogeneous groups of patients admitted to a subacute care unit. The Royal Brisbane and Women's Hospital (RBWH) dysphagia screening tool is a nurse-administered, evidence-based swallow screening tool for generic acute hospital use that demonstrates excellent sensitivity and specificity. No Italian version of this tool is available to date. The aim of this study was to determine the reliability and screening accuracy of the Italian version of the RBWH (I-RBWH) dysphagia screening tool. A total of 105 patients consecutively admitted to a subacute care unit were enrolled. Using the I-RBWH tool, each patient was evaluated twice by trained nurses and once by a speech and language pathologist (SLP) blind to nurses' scores. The SLP also performed standardised clinical assessment of swallowing using the Mann assessment of swallowing ability (MASA). During the first and the second administration of the I-RBWH by nurses, 28 and 27 patients, respectively, were considered at risk of dysphagia, and 27 were considered at risk after SLP assessment. Intra- and inter-rater reliability was satisfactory. Comparison between nurse I-RBWH scores and MASA examination demonstrated a sensitivity and specificity of the I-RBWH dysphagia screening tool up to 93% and 96%, respectively; the positive and negative predictive values were 90% and 97%, respectively. Thus, the current findings support the reliability and accuracy of the I-RBWH tool for dysphagia screening of patients in subacute settings. Its application in clinical practice is recommended.

Statin use and risk of new-onset diabetes: A meta-analysis of observational studies.

BACKGROUND AND AIMS: Meta-analyses of randomized control trials investigating the association between incident diabetes and statin use showed an increased risk of new-onset diabetes (NOD) from 9% to 13% associated with statins. However, short follow-up period, unpowered sample size, and lack of pre-specified diagnostic criteria for diabetes detection could be responsible of an underestimation of this risk. We conducted a meta-analysis of published observational studies to evaluate the association between statins use and risk of NOD. METHODS AND RESULTS: PubMed, EMBASE and MEDLINE databases were searched from inception to June 30, 2016 for cohort and case-control studies with risk of NOD in users vs nonusers, on ≥1000 subjects followed-up for ≥1 year. Two review authors assessed study eligibility and risk of bias and undertook data extraction independently. Pooled estimates were calculated by a random-effects model and between-study heterogeneity was tested and measured by I2 index. Furthermore, stratified analyses and the evaluation of publication bias were performed. Finally, the meta-analysis included 20 studies, 18 cohort and 2 case-control studies. Overall, NOD risk was higher in statin users than nonusers (RR 1.44; 95% CI 1.31-1.58). High between-study heterogeneity (I2 = 97%) was found. Estimates for all single statins showed a class effect, from rosuvastatin (RR 1.61; 1.30-1.98) to simvastatin (RR 1.38; 1.19-1.61). CONCLUSIONS: The present meta-analysis confirms and reinforces the evidence of a diabetogenic effect by statins utilization. These observations confirm the need of a rigorous monitoring of patients taking statins, in particular pre-diabetic patients or patients presenting with established risk factors for diabetes.

Cross-Cultural Adaptation and Validation of the Italian Version of the Voice Symptom Scale (I-VoiSS).

OBJECTIVES: To evaluate the reliability and validity of the Italian Voice Symptom Scale (I-VoiSS). STUDY DESIGN: Cross-sectional, nonrandomized, prospective study with controls. METHODS: The study consisted of five phases: item generation, reliability analysis, normative data generation, validity and responsiveness analysis. A group of 113 dysphonic patients was enrolled for the internal consistency analysis. Seventy-three of them completed the I-VoiSS twice, 2 weeks apart, for test-retest reliability analysis. A group of 150 vocally healthy participants completed the I-VoiSS for normative data generation. I-VoiSS scores obtained by dysphonic and vocally healthy participants were compared for validity analysis. I-VoiSS scores were correlated with those of the Italian version of the Voice Handicap Index (I-VHI) in 49 dysphonic patients for criterion validity analysis. I-VoiSS scores obtained in a group of 37 nonsmoker dysphonic patients before and after surgical treatment for vocal fold polyps were compared for responsiveness analysis. Finally, the cutoff value of the I-VoiSS was calculated. RESULTS: All the enrolled participants managed to complete the I-VoiSS autonomously. Internal consistency and test-retest were satisfactory (α = 0.92 and r = 0.91). A significant difference in the I-VoiSS scores between the dysphonic and vocally healthy participants was found (p = 0.001). Positive significant correlations were found between I-VoiSS and I-VHI scores (r = 0.85). I-VoiSS scores obtained in the pretreatment condition were significantly higher than those obtained after surgery (p = 0.001). The cutoff value of I-VoiSS was 15.5. CONCLUSION: I-VoiSS is reliable, valid, responsive to changes, and recommended for clinical practice and outcome research.

Reliability, validity and normative data of the Italian version of the Bus Story test.

OBJECTIVES: Evaluation of the reliability and the validity of the Italian version of the Bus Story Test (I-BST), providing normative data in Italian children. METHODS: A total of 552 normally developing children (278 males and 274 females) aged 3; 6 to 9; 0 years, were enrolled. Test-retest, intra- and inter-rater reliability were analysed on a sample of respectively 145, 178 and 178 children. Normative data were gathered from all the enrolled children and estimate centiles according to the CG-LMS method provided. The children were divided into 11 age classes of six months each; percentile scores and standard error measurement were analysed in children from age class 4; 0-4; 5 years to age class 8; 6-811 years. Age effects on I-BST were analysed. RESULTS: Results showed high test-retest, intra- and inter-rater reliability scores. A significant age effect on I-BST scores emerged from the ANOVA test analysis; in particular, as age increases, so do I-BST scores. CONCLUSION: The I-BST is a reliable and valid tool. The availability of normative data for Italian speaking children may help clinicians during clinical assessment.

Cross-cultural adaptation and validation of the Nijmegen Cochlear Implant Questionnaire into Italian.

The NCIQ is a quantifiable self-assessment health-related quality of life instrument specific for cochlear implant users. The aim of this study was to culturally adapt the NCIQ into Italian (I-NCIQ). A prospective instrument validation study was conducted. Cross-cultural adaptation and validation were accomplished. Cronbach α was used to test internal consistency in 51 CI users and in a control group composed by 38 post-lingual deaf adult on a waiting list for a CI. ICC test was used for test-retest reliability analysis. Kruskal-Wallis test with Mann-Whitney post hoc were used to compare the I-NCIQ scores in CI users before and after the cochlear implantation and in control patients. I-NCIQ scores obtained in CI users were compared with the results of Italian version of disyllabic testing without lip-reading and without masking. Good internal consistency and good test-retest reliability were found. I-NCIQ scores obtained in the 51 CI users after implantation were consistently higher than those obtained before implantation and in the control group. Moreover, no differences were found in the results of I-NCIQ obtained in the group of 51 CI users before implantation and in the group of control patients on post hoc Mann-Whitney analysis. Positive correlations between I-NCIQ scores and the results of disyllabic testing without lip-reading and without masking were found. The I-NCIQ is a reliable, valid, self-administered questionnaire for the measurement of QOL in CI users; its application is recommended.

Vomer aplasia in a patient carrying a de novo mutation of the TP63 gene (3q27).

The congenital vomer defect (CVD) is a rare and still partially unknown condition. Only few cases have been reported in the international literature and the large majority of them appeared to be isolated. We report a case of CVD detected in a 7-year-old girl affected by ectodermal dysplasia clefting syndrome caused by a mutation of the TP63 gene.

Reliability of the Italian INFVo scale and correlations with objective measures and VHI scores.

The objective of this study was to evaluate the reliability of the INFVo scale and its relationship with objective measures and VHI scores in 40 native Italian-speaking patients with substitution voice. The maximum phonation time (MPT), diadochokinesis (DDK) of the three syllabic sequence [pa/ta/ka], reading of a passage and a single word repetition test were recorded. Each patient completed the Italian version of the VHI. Three speech-language pathologists blindly rated the recordings using the auditory perceptual INFVo scale; one listened and assessed the voice recording twice. The INFVo intra- and inter-rater reliability reached good values. Strong to moderate correlations between the INFVo scale scores and MPT, DDK, distortions in the repetition test, speech rate during reading and the functional subscale of the VHI were found. In conclusion, the INFVo scale is a reliable tool and can be recommended for the perceptual assessment of substitution voices in Italian speaking patients.

Reliability and validity of the Italian version of the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V).

OBJECTIVES: To evaluate the reliability and validity of the Italian version of the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V). PATIENTS AND METHODS: Eighty dysphonic patients and 120 asymptomatic subjects were enrolled. The voice signal of each participant was recorded, listened to and rated by 3 licensed speech-language pathologists using the GRBAS scale and the Italian version of the CAPE-V. The intra- and interrater reliability of the CAPE-V was assessed as well as the degree of association between the CAPE-V and GRBAS judgments. The CAPE-V values were also compared between the patients with dysphonia and the asymptomatic subjects. RESULTS: The intra- and interrater reliability appeared to be good for all the parameters except for the strain parameter. The attributes 'consistent' and 'intermittent' demonstrated optimal intra- and interrater reliability. The difference between pathological and control groups was significant for six perceptual parameters. The highest average correlation between GRBAS and CAPE-V judgments was found between overall severity and grade while the lowest was found between the two strain scales. CAPE-V profiles differed significantly between different pathological groups. CONCLUSION: The Italian version of CAPE-V appears to be a reliable and valid tool for the perceptual analysis of the voice signal.

Vocal improvement after voice therapy in the treatment of benign vocal fold lesions.

Benign vocal fold lesions are common in the general population, and have important public health implications and impact on patient quality of life. Nowadays, phonomicrosurgery is the most common treatment of these lesions. Voice therapy is generally associated in order to minimize detrimental vocal behaviours that increase the stress at the mid-membranous vocal folds. Nonetheless, the most appropriate standard of care for treating benign vocal fold lesion has not been established. The aim of this study was to analyze voice changes in a group of dysphonic patients affected by benign vocal fold lesions, evaluated with a multidimensional protocol before and after voice therapy. Sixteen consecutive patients, 12 females and 4 males, with a mean age of 49.7 years were enrolled. Each subject had 10 voice therapy sessions with an experienced speech/language pathologist for a period of 1-2 months, and was evaluated before and at the end of voice therapy with a multidimensional protocol that included self-assessment measures and videostroboscopic, perceptual, aerodynamic and acoustic ratings. Videostroboscopic examination did not reveal resolution of the initial pathology in any case. No improvement was observed in aerodynamic and perceptual ratings. A clear and significant improvement was visible on Wilcoxon signed-rank test for the mean values of Jitt%, Noise to Harmonic Ratio (NHR) and Voice Handicap Index (VHI) scores. Even if it is possible that, for benign vocal fold lesions, only a minor improvement of voice quality can be achieved after voice therapy, rehabilitation treatment still seems useful as demonstrated by improvement in self-assessment measures. If voice therapy is provided as an initial treatment to the patients with benign vocal fold lesions, this may lead to an improvement in the perceived voice quality, making surgical intervention unnecessary. This is one of the first reports on the efficacy of voice therapy in the management of benign vocal fold lesions; further studies are needed to confirm these preliminary data.

Surgical management of a life-threatening retro-pharyngeal haematoma following trans-oesophageal echocardiography.

Trans-oesophageal echocardiography is generally considered a safe procedure, but occasional life-threatening complications have been reported. The aim of this clinical investigation is to outline the need of surgical management in cases of large retro-pharyngeal haematoma following trans-oesophageal echocardiography. In the case reported here, a patient with cervical spondylosis on anti-coagulant therapy was referred to the Head and Neck Department because of a retro-pharyngeal haematoma with severe upper airway obstruction following transoesophageal echocardiography. Tracheotomy was required to guarantee respiratory function, while trans-cervical surgery was performed to evacuate the haematoma. Total recovery was achieved within 10 days. In conclusion, the head and neck surgeon should consider the need of surgical management in cases of retro-pharyngeal haematoma following trans-oesophageal echocardiography.