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.

The role of progestogen supplementation (dydrogesterone) in the prevention of preeclampsia.

Our goal was determine the effects of dydrogesterone supplementation to reduce the incidence of preeclampsia (PE) in early pregnancy (from 6 to 20 weeks of gestation). A total of 406 pregnant women were involved into the study. The Study group enrolled 169 women, supplemented with dydrogesterone at a dose of 30 mg/d 6-20 weeks of gestation compared with the control group (237 subjects) - without dydrogesterone supplementation. The women were randomized by age, race, obstetrics complications, and their somatic history. The use of dydrogesterone in early pregnancy - before 20 weeks of gestation (at a dose of 30 mg/d) with high-risk factors of PE contributed to a statistically significant reduction in the frequency of this complication (13.1% and 71.4%, p < .001). It was seen, that women who took dydrogesterone developed significantly less such disorders like hypertension (3.2% and 71.2%, p < .001), proteinuria (0.0% and 66.18%, p < .001), fetal growth retardation syndrome (2.2% and 21.58%, p < .001), destroy of uteri-placenta velocity (3.2% and 21.58%, p < .001), preterm labor (8.6% and 53.95%, p < .001). Dydrogesterone supplementation in the first and second period of pregnancy (from 6 to 20 weeks of gestation) significantly reduced the incidence of PE in women with higher risk pregnancy.

The efficacy of myofunctional therapy in patients with atypical swallowing.

PURPOSE: The myofunctional treatment (MFT) is a conventional therapy in the treatment of oral disease like atypical swallowing (AS). Functional (standardized surface electromyographic analysis-ssEMG) and clinical ("orofacial muscular evaluation with score" protocol-OMES) analyses were conducted to detect the effects of MFT (10 weeks session) in a group of patients with AS. METHODS: ssEMG was performed to analyze the activity of masseter (MM), temporalis (TA), and submental (SM) muscles before (T1) and after (T2) the MFT in a group of 15 patients. OMES was completed at the same timepoints. A Student-t test was carried out to detect differences between T1 and T2 for ssEMG data, and a signed RANK test was used for OMES ones. One-way ANOVA variance test was performed to detect any differences between the different couples of muscles at each timepoint. RESULTS: After MFT, patients showed a shorter duration of the whole act of swallowing (p < .0001), higher intensity of the SM activity (p < .01) than at T1. At T2 masticatory muscles showed lower values for the activation index (ANOVA, p < .0001) and for the spike position (ANOVA, p < .01) than SM. The OMES protocol showed a significant increase for the total evaluation score (p < .01), appearance-posture (p < .01) and functions (p < .001). CONCLUSIONS: MFT permits a shortening of the muscular activation pattern and an increase in SM activity. The improvement of oral functionalities is possible and identifiable thanks to the use of standardized protocols.

Operation, hormone therapy and recovery of the patients with severe forms of adenomyosis.

Endometriosis is among the prevalent gynecological diseases and diagnosed in 10% of women of reproductive age. Endometriosis/adenomyosis is becoming increasingly a health-social problem, which is associated with severe clinical manifestations and recurrent disease which has a negative effect on quality of life, women ability to work and her reproductive function. This article presents modern approaches of drug therapy to treat severe forms of adenomyosis. We have reviewed recent major studies in the field of surgical treatment of this disease, analyzed the main stages of disease progress and the results of our surgeries. Here, we are presenting our own results of long-term post-operative hormonal therapy and complex medical treatment.

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.

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.

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.

Blast-related disinhibition and risk seeking in mice and combat Veterans: Potential role for dysfunctional phasic dopamine release.

Mild traumatic brain injury (mTBI) caused by exposure to high explosives has been called the "signature injury" of the wars in Iraq and Afghanistan. There is a wide array of chronic neurological and behavioral symptoms associated with blast-induced mTBI. However, the underlying mechanisms are not well understood. Here we used a battlefield-relevant mouse model of blast-induced mTBI and in vivo fast-scan cyclic voltammetry (FSCV) to investigate whether the mesolimbic dopamine system contributes to the mechanisms underlying blast-induced behavioral dysfunction. In mice, blast exposure increased novelty seeking, a behavior closely associated with disinhibition and risk for subsequent maladaptive behaviors. In keeping with this, we found that veterans with blast-related mTBI reported greater disinhibition and risk taking on the Frontal Systems Behavior Scale (FrSBe). In addition, in mice we report that blast exposure causes potentiation of evoked phasic dopamine release in the nucleus accumbens. Taken together these findings suggest that blast-induced changes in the dopaminergic system may mediate aspects of the complex array of behavioral dysfunctions reported in blast-exposed veterans.

Evaluating the Psychometric Properties of the Eating Assessment Tool (EAT-10) Using Rasch Analysis.

Early and reliable screening for oropharyngeal dysphagia (OD) symptoms in at-risk populations is important and a crucial first stage in effective OD management. The Eating Assessment Tool (EAT-10) is a commonly utilized screening and outcome measure. To date, studies using classic test theory methodologies report good psychometric properties, but the EAT-10 has not been evaluated using item response theory (e.g., Rasch analysis). The aim of this multisite study was to evaluate the internal consistency and structural validity and conduct a preliminary investigation of the cross-cultural validity of the EAT-10; floor and ceiling effects were also checked. Participants involved 636 patients deemed at risk of OD, from outpatient clinics in Spain, Turkey, Sweden, and Italy. The EAT-10 and videofluoroscopic and/or fiberoptic endoscopic evaluation of swallowing were used to confirm OD diagnosis. Patients with esophageal dysphagia were excluded to ensure a homogenous sample. Rasch analysis was used to investigate person and item fit statistics, response scale, dimensionality of the scale, differential item functioning (DIF), and floor and ceiling effect. The results indicate that the EAT-10 has significant weaknesses in structural validity and internal consistency. There are both item redundancy and lack of easy and difficult items. The thresholds of the rating scale categories were disordered and gender, confirmed OD, and language, and comorbid diagnosis showed DIF on a number of items. DIF analysis of language showed preliminary evidence of problems with cross-cultural validation, and the measure showed a clear floor effect. The authors recommend redevelopment of the EAT-10 using Rasch analysis.

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.

A pilot study to determine whether progestogen supplementation using dydrogesterone during the first trimester will reduce the incidence of gestational hypertension in primigravidae.

BACKGROUND: Gestational hypertension (GH) remains one of the main causes of high maternal and perinatal morbidity and mortality worldwide with the highest incidence among primigravidae of about 10%-15%. However, it was noted that the incidence of GH in primigravidae who conceived following assisted reproductive technique (ART) or intrauterine insemination (IUI) supplemented with dydrogesterone during the first trimester was low. AIM: To determine whether dydrogesterone supplementation during the first trimester can reduce the incidence of GH among primigravidae. METHOD: A prospective cross-sectional comparative study was undertaken in 2010 on 116 primigravidae (study group) who conceived following ART or IUI and supplemented with dydrogesterone up to 16 weeks gestation. They were matched for age and race at 16 weeks gestation with a control patient from the early pregnancy clinic who were primigravidae (n = 116) who conceived spontaneously without dydrogesterone supplementation. FINDINGS: The incidence of GH in the study group was significantly lower than the control group (1.7% versus 12.9%, p = 0.001). The incidence of fetal distress was also significantly lower in the study group compared to the control group (4.3% versus 18.1%, p = 0.001). INTERPRETATION: Dydrogesterone supplementation during the first trimester significantly reduced the incidence of GH and fetal distress in primigravidae.

Factors in rehospitalisation for severe pressure ulcer care in spinal cord injury/disorders.

OBJECTIVE: Repeated hospital admissions (RHA) for ongoing pressure ulcer (PU) care remains a significant challenge in the clinical management of the spinal cord injury/disorders (SCI/D) population. The current study investigated the significance of risk factors for PU treatment and RHA. METHOD: A retrospective chart review of veterans admitted to the Louis Stokes Cleveland Department of Veterans Affairs Medical Center (LSCDVAMC) Spinal Cord Injury (SCI) unit for Category III or IV PUs was carried out. A random sample of 105 individuals with SCI/D, evaluated by the Wound Care Team (WCT) from 2006 to 2009 was assessed. Multiple PU development risk factors were extracted from the electronic health record system using standardised data collection forms and entered into the Spinal Cord Injury Pressure Ulcer Database (SCIPUD). Potential associations with RHA were analysed. RESULTS: Twenty variables were initially identified as potentially related to PU development. Descriptive statistics and statistically significant associations between risk factors and RHA were determined. Demographic factors showed no significant association with RHA. Duration of injury, power wheelchair use and sub-optimally managed spasticity (SMS) were significantly associated with higher RHA. Sub-optimally managed neurogenic bowel (SMNB) at admission was significantly associated with reduced RHA. CONCLUSION: Factors previously found to be predictive of initial PU development may not, in fact, be predictive of RHA. Some protective trends were observed, such as polypharmacy and marital status, but these did not reach statistical significance in this preliminary study of admission characteristics, warranting further research. DECLARATION OF INTEREST: There were no external sources of funding for this study. The authors have no conflicts of interests to declare.

ICU personnel have inaccurate perceptions of their patients' experiences.

BACKGROUND: Intensive care unit (ICU) patient care bases - among others - upon the staff's assumptions about each patient's subjective preferences and experiences. However, these assumptions may be skewed and thus result in client-professional gaps (cp-gaps), which occur in two subtypes, hyperattention and blind spots to certain burdens. cp-gaps typically reduce quality of care. We investigated whether cp-gaps of either subtype exist in a 36-bed ICU of a university hospital. METHODS: Observational study on 82 consecutive patients of a 36-bed university ICU, who voluntarily answered a psychometric questionnaire focusing on patients' experiences during an ICU stay. The questionnaire was reliable and valid (Cronbach's alpha, factor analysis). It consisted of 31 Likert-scaled items, which represented three scales of perception (communicative, intrapersonal, somatic) supplemented by 55 binary items for more specific information. Details of the questionnaire are given in the text. Demographic, educational, and medical data were registered too. Patients reported their subjective ICU experience 2-7 days after ICU discharge. Analogously, 60 staff members (physicians and nurses) reported their assumptions about patients' experiences. After correction for a general bias, group differences indicated cp-gaps. RESULTS: Twelve cp-gaps were found. Hyperattention was found in four communicative and three intrapersonal items. Blind spots appeared in two communicative, two intrapersonal, and one somatic item. The pattern of cp-gap subtypes (hyperattention/blind spots) goes well with self-attributional bias - a model of social interaction. CONCLUSIONS: cp-gaps in ICUs can be identified using analogue questionnaires for patients and staff. Both subtypes of cp-gap occur. cp-gaps are substantially influenced by self-attributional bias.

Implementation of certified endometriosis centers: 5-year experience in German-speaking Europe.

The idea of quality improvement in the management of endometriosis has been brought to attention throughout Europe. This - first and foremost - includes the implementation of centers specialized in treating endometriosis. This leads to qualification of both physicians and other medical staff, enforcement of research efforts, and informing the patients, the public, politicians, healthcare providers, and industry. Given limited budgets, focusing on the existing national commitment may be the first step.

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.

History and Science behind the Eating Assessment Tool-10 (Eat-10): Lessons Learned.

INTRODUCTION: Oropharyngeal dysphagia (OD) is an underdiagnosed medical condition with a high prevalence in populations such as patients with frailty, neurological disease, or head and neck pathology. Potential barriers to its diagnosis include lack of (or low) awareness of the existence and severity of the condition, the hidden nature of the condition within the 'normal ageing' process, clinical limitations, and socioeconomic reasons. Consequently, an effective treatment is not systematically offered in a timely manner, and complications, such as dehydration and respiratory infections or aspiration pneumonia, can arise. To overcome this issue, the early use of screening questionnaires to identify people at risk of swallowing disorders represents the cornerstone of preventive medicine. Several screening tools have been created but few are widely used in clinical practice. The Eating Assessment Tool-10 (EAT-10) was developed as a quick, easy-to-understand, and self-administered screening tool for OD. METHODS: A literature review was conducted in five databases with no restrictions on the language, date of publication, or design of the study to identify aspects of the validation, applicability, and usefulness of EAT-10. RESULTS AND CONCLUSIONS: Transcultural adaptation and translation studies, as well as studies involving various types of patients with dysphagia in different settings have shown the validity and reliability of EAT-10 in relation to the gold standard and other validation tools. The use of this standardised screening tool could be used as a primary screening instrument of dysphagia in routine clinical practice across a wide range of diseases and settings and thereby increase the likelihood of early diagnosis and management of a condition that lead to serious complications and impaired quality of life.

Liquid-chromatographic profiling of Saponinum album (Merck).

Saponinum album (Merck) is a complex composite of triterpene saponins. It was shown that Saponinum album (Merck) dramatically enhances the toxicity of the N-glycosylase saporin from the seeds of Saponaria officinalis L. as well as the toxicity of a saporin based anti-tumor toxin. This study was intended to chromatographically profile the saponins present in Saponinum album (Merck) in order to identify saponins that determine the cytotoxicity enhancing properties of Saponinum album (Merck) on saporin. For this purpose a liquid-chromatographic profiling (HPLC) followed by ESI-TOF-MS analysis and evaluation of cytotoxicity enhancer effects of saponins from Saponinum album (Merck) was performed. This is the first study describing a liquid-chromatographic profiling of saponins from Saponinum album (Merck). Ten different saponins were isolated. There was a lot of variation observed in the cytotoxicity enhancing properties of different isolated saponins, 8 out of 10 isolated saponins showed an enhancer effect on the toxicity of saporin. Based on these results it was concluded that the cytotoxicity enhancer effect of Saponinum album (Merck) is not attributable to a single, activity determining saponin.

Repeated exposure of the oral mucosa over 12 months with cold plasma is not carcinogenic in mice.

Peri-implantitis may result in the loss of dental implants. Cold atmospheric pressure plasma (CAP) was suggested to promote re-osseointegration, decrease antimicrobial burden, and support wound healing. However, the long-term risk assessment of CAP treatment in the oral cavity has not been addressed. Treatment with two different CAP devices was compared against UV radiation, carcinogen administration, and untreated conditions over 12 months. Histological analysis of 406 animals revealed that repeated CAP exposure did not foster non-invasive lesions or squamous cell carcinoma (SCCs). Carcinogen administration promoted non-invasive lesions and SCCs. Molecular analysis by a qPCR screening of 144 transcripts revealed distinct inflammatory profiles associated with each treatment regimen. Interestingly, CAP treatment of carcinogen-challenged mucosa did not promote but instead left unchanged or reduced the proportion of non-invasive lesions and SCC formation. In conclusion, repeated CAP exposure of murine oral mucosa was well tolerated, and carcinogenic effects did not occur, motivating CAP applications in patients for dental and implant treatments in the future.

Non-contraceptive benefits of hormonal contraceptives.

Besides the contraceptive effect of the various hormonal contraceptives, it is intended to demonstrate the non-contraceptive health benefits for treatment and prevention of bleeding problems, menstruation-related pain and other disorders, such as premenstrual syndrome and signs of androgenization. The effectiveness can be improved by choosing the proper progestogen with antiandrogenic action. Treatment but also prevention can be achieved with hormonal contraceptives in benign proliferative diseases of women, such as ovarian cysts, endometriosis, adenomyosis, endometrial hyperplasia, myoma and benign breast disease. Furthermore, hormonal contraceptives such as estrogen/progestogen combinations reduce pelvic inflammatory disease, rheumatoid arthritis, asthma symptoms and preserve bone density. In addition, a major impact in oncological prevention seems to be possible for ovarian, endometrial and colon cancer and these positive preventive effects seem to persist also after discontinuation of hormonal contraceptives. In addition, practical concepts for hormonal contraceptive selection will be outlined.