Prognostic role and interaction of TERT promoter status, telomere length and MGMT promoter methylation in newly diagnosed IDH wild-type glioblastoma patients.

BACKGROUND: The clinical relevance of promoter mutations and single nucleotide polymorphism rs2853669 of telomerase reverse transcriptase (TERT) and telomere length in patients with isocitrate dehydrogenase (IDH) wild-type glioblastoma (GBM) patients remains unclear. Moreover, some studies speculated that TERT promoter status might influence the prognostic role of O6-methylguanine DNA methyltransferase (MGMT) promoter methylation in newly diagnosed GBM. We carried out a large study to investigate their clinical impact and their interaction in newly diagnosed GBM patients. PATIENTS AND METHODS: We included 273 newly diagnosed IDH wild-type GBM patients who started treatment at Veneto Institute of Oncology IOV - IRCCS (Padua, Italy) from December 2016 to January 2020. TERT promoter mutations (-124 C>T and -146 C>T) and SNP rs2853669 (-245 T>C), relative telomere length (RTL) and MGMT methylation status were retrospectively assessed in this prospective cohort of patients. RESULTS: Median overall survival (OS) of 273 newly diagnosed IDH wild-type GBM patients was 15 months. TERT promoter was mutated in 80.2% of patients, and most had the rs2853669 single nucleotide polymorphism as T/T genotype (46.2%). Median RTL was 1.57 (interquartile range 1.13-2.32). MGMT promoter was methylated in 53.4% of cases. At multivariable analysis, RTL and TERT promoter mutations were not associated with OS or progression-free survival (PFS). Notably, patients C carrier of rs2853669 (C/C+C/T genotypes) showed a better PFS compared with those with the T/T genotype (hazard ratio 0.69, P = 0.007). In terms of OS and PFS, all interactions between MGMT, TERT and RTL and between TERT and rs2853669 genotype were not statistically significant. CONCLUSIONS: Our findings suggest the presence of the C variant allele at the rs2853669 of the TERT promoter as an attractive independent prognostic biomarker of disease progression in IDH wild-type GBM patients. RTL and TERT promoter mutational status were not correlated to survival regardless of MGMT methylation status.

Three-dimensional transvaginal ultrasound vs magnetic resonance imaging for preoperative staging of deep myometrial and cervical invasion in patients with endometrial cancer: systematic review and meta-analysis.

OBJECTIVES: To evaluate and compare the diagnostic test accuracy (DTA) of three-dimensional transvaginal ultrasound (3D-TVS) and magnetic resonance imaging (MRI) for deep myometrial infiltration (DMI) and cervical invasion for preoperative staging and surgery planning in patients with endometrial cancer (EC). METHODS: This systematic review and meta-analysis investigated the DTA of MRI and 3D-TVS for DMI and cervical invasion in patients with EC. A literature search was performed using MEDLINE, Scopus, EMBASE, ScienceDirect, The Cochrane library, ClinicalTrials.gov, Cochrane Central Register of Controlled Trials, EU Clinical Trials Register and World Health Organization International Clinical Trials Registry Platform to identify relevant studies published between January 2000 and December 2021. Study quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. RESULTS: Five studies, including a total of 450 patients, were included in the systematic review. All five studies compared the DTA of 3D-TVS vs MRI for DMI, and three studies compared the DTA of 3D-TVS vs MRI for cervical invasion. Pooled sensitivity, positive likelihood ratio and negative likelihood ratio for detecting DMI using 3D-TVS were 77% (95% CI, 66-85%), 4.57 and 0.31, respectively. The respective values for detecting DMI on MRI were 80% (95% CI, 73-86%), 4.22 and 0.24. Bivariate metaregression indicated a similar DTA of 3D-TVS and MRI (P = 0.80) for the correct identification of DMI. Pooled ln diagnostic odds ratio for detecting cervical invasion was 3.11 (95% CI, 2.09-4.14) for 3D-TVS and 2.36 (95% CI, 0.90-3.83) for MRI. The risk of bias was low for most of the four domains assessed in QUADAS-2. CONCLUSION: 3D-TVS demonstrated good diagnostic accuracy in terms of sensitivity and specificity for the evaluation of DMI and cervical invasion, with results comparable with those of MRI. Thus, we confirmed the potential role of 3D-TVS in the preoperative staging and surgery planning in patients with EC. © 2022 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

The impact of the COVID-19 pandemic on health service use in sub-Saharan Africa.

SETTING: Six hospitals in four sub-Saharan African countries. OBJECTIVE: To examine the indirect effects of COVID-19 on health service utilisation and to explore the risk of bias in studies on prediction models. DESIGN: Monthly data were analysed using interrupted time-series modelling. We used linear mixed-effect models for the analysis of antenatal care visits, institutional deliveries, vaccinations, outpatient visits and hospital admissions, and generalised linear mixed-effect models for hospital mortality. RESULTS: During 2018-2020, the six hospitals recorded a total of 57,075 antenatal care visits, 38,706 institutional deliveries, 312,961 vaccinations, 605,925 out-patient visits and 143,915 hospital admissions. The COVID-19 period was associated with decreases in vacci-nations (- 575 vaccinations, P < 0.0001), outpatient visits (- 700 visits, P < 0.0001) and hospital admission (- 102 admission, P = 0.001); however, no statistically significant effects were found for antenatal care visits (P = 0.71) or institutional deliveries (P = 0.14). Mortality rate increased by 2% per month in the pre-COVID-19 period; however, a decreasing trend (by 2% per month) was observed during the COVID-19 period (P = 0.004). Subgroup and sensitivity analyses broadly confirmed the main findings with only minor inconsistencies. A reduction in outpatient visits was also observed in hospitals from countries with a higher Stringency Index and in urban hospitals. CONCLUSIONS: The pandemic resulted in a reduction in health service utilisation. The decreases were less than anticipated from modelling studies.

CONTEXTE: Six hôpitaux de quatre pays d'Afrique subsaharienne. OBJECTIF: Examiner les effets indirects de la COVID-19 sur l'utilisation des services de santé et analyser le risque de biais dans les études utilisant des modèles de prédiction. MÉTHODES: Des données mensuelles ont été analysées en utilisant une modélisation de séries chronologiques interrompues. L'analyse principale a mis en place des modèles linéaires à effets mixtes (pour les consultations anténatales, les accouchements en institutions, les vaccinations, les consultations ambulatoires et les admissions à l'hôpital) et des modèles linéaires généralisés à effets mixtes (pour la mortalité hospitalière). RÉSULTATS: En 2018­2020, les six hôpitaux ont enregistré un total de 57 075 consultations anténatales, 38 706 accouchements en institutions, 312 961 vaccinations, 605 925 consultations ambulatoires et 143 915 admissions hospitalières. La période de la COVID-19 a été associée à une baisse des vaccinations (− 575 vaccinations, P<0,0001), des consultations ambulatoires (− 700 consultations, P < 0,0001) et des admissions hospitalières (− 102 admissions, P = 0,001). Cependant, aucun effet statistiquement significatif n'a été observé pour les consultations anténatales (P = 0,71) ou les accouchements en institutions (P = 0,14). Le taux de mortalité augmentait de 2% par mois avant la période de la COVID-19, mais nous avons observé une tendance à la baisse (de 2% par mois) pendant la période de la COVID-19 (P = 0,004). Les analyses des sous-groupes et de sensibilité ont globalement confirmé les résultats principaux ; seules des incohérences mineures ont été observées. Une diminution des consultations ambulatoires a également été observée dans les hôpitaux des pays dont l'Indice de sévérité des mesures publiques était plus élevé, ainsi que dans les hôpitaux urbains. CONCLUSIONS: La pandémie a été associée à une utilisation réduite des services de santé. Ces diminutions étaient moindres que celles anticipées par les études de modélisation.

Implantable and transcutaneous continuous glucose monitoring system: a randomized cross over trial comparing accuracy, efficacy and acceptance.

AIM: To compare accuracy, efficacy and acceptance of implantable and transcutaneous continuous glucose monitoring (CGM) systems. METHODS: In a randomized crossover trial we compared 12 weeks with Eversense implantable sensor (EVS) and 12 weeks with Dexcom G5 transcutaneous sensor (DG5) in terms of accuracy, evaluated as Mean Absolute Relative Difference (MARD) vs capillary glucose (SMBG), time of CGM use, adverse events, efficacy (as HbA1c, time in range, time above and below range) and psychological outcomes evaluated with Diabetes Treatment Satisfaction Questionnaire (DTSQ), Glucose Monitoring Satisfaction Survey (GMSS), Hypoglycemia Fear Survey (HFS2), Diabetes Distress Scale (DDS). RESULTS: 16 subjects (13 males, 48.8 ± 10.1 years, HbA1c 55.8 ± 7.9 mmol/mol, mean ± SD) completed the study. DG5 was used more than EVS [percentage of use 95.7 ± 3.6% vs 93.5 ± 4.3% (p = 0.02)]. MARD was better with EVS (12.2 ± 11.5% vs. 13.1 ± 14.7%, p< 0.001). No differences were found in HbA1c. While using EVS time spent in range increased and time spent in hyperglycemia decreased, but these data were not confirmed by analysis of retrofitted data based on SMBG values. EVS reduced perceived distress, without significant changes in other psychological outcomes. CONCLUSIONS: CGM features may affect glycemic control and device acceptance.

Vitamin D status and non-alcoholic fatty liver disease in patients with type 1 diabetes.

PURPOSE: In patients with type 1 diabetes (T1D), the prevalence of non-alcoholic fatty liver disease (NAFLD) ranges from 10 to 53% and contrasting evidence suggests that vitamin D deficiency may favor liver fat accumulation. Here, we investigated the association between vitamin D status and NAFLD in adults with T1D. METHODS: 220 consecutive adult T1D patients on multiple daily injections or continuous subcutaneous insulin infusion and not taking calcium or vitamin D supplements were included. Patient characteristics, 25(OH)D serum levels, and metabolic parameters were analyzed. Vitamin D status was defined as sufficiency ( ≥ 75 nmol/L; 30 ng/ml), insufficiency (50-75 nmol/L; 20-30 ng/ml), or deficiency ( < 50 nmol/L; 20 ng/ml). NAFLD was diagnosed at ultrasound examination and graded 0-3. RESULTS: NAFLD was present in 57 patients (29.5%): 51 grade 1, 5 grade 2, and 1 grade 3. Median 25(OH)D levels were 53 nmol/L (IQR 38-70) in patients with NAFLD and 50 nmol/L (34-69) in patients without (p = 0.46). At multivariable analysis, NAFLD was not associated with 25(OH)D levels (p = 0.42) or vitamin D deficiency (p = 0.55), while BMI (OR 1.16, 95% CI 1.07-1.27) and serum triglycerides (OR 1.02, 95% CI 1.01-1.03) were independently associated with NAFLD. CONCLUSIONS: Vitamin D status appears to have no link with low-grade NAFLD in patients with type 1 diabetes.

Randomized clinical trial of psychological support and sleep adjuvant measures for postoperative sleep disturbance in patients undergoing oesophagectomy.

BACKGROUND: Major surgery such as oesophagectomy requires a postoperative stay in intensive care. Painful stimuli lead to sleep disturbance and impairment in quality of life. The aim of this study was to evaluate the effect of psychological counselling and sleep adjuvant measures on postoperative quality of sleep and quality of life. METHODS: This RCT was performed between January 2013 and October 2015. Patients undergoing oesophagectomy for cancer were randomized into one of four groups receiving: psychological counselling plus sleep adjuvant measures during the ICU stay; psychological counselling alone; sleep adjuvant measures alone during the ICU stay; or standard care. The primary endpoint was impairment in quality of life measured using the European Organisation for Research and Treatment of Cancer C30-QL2 questionnaire between admission for surgery and discharge from hospital. The secondary endpoint was impairment in quality of sleep assessed by means of the Pittsburgh Sleep Quality Index between admission for surgery and hospital discharge. RESULTS: The local ethics committee approved the early termination of the study because of relevant changes in the ICU setting. Some 87 patients were randomized and 74 patients were evaluated in the analysis. Psychological counselling reduced the impairment in quality of life (odds ratio 0·23, 95 per cent c.i. 0·09 to 0·61) and in quality of sleep (odds ratio 0·27, 0·10 to 0·73). CONCLUSION: Perioperative psychological support reduces impairment in quality of life and quality of sleep after oesophagectomy. Registration number: NCT01738620 (http://www.clinicaltrials.gov).

A systematic review of segmental vs subtotal colectomy and subtotal colectomy vs total proctocolectomy for colonic Crohn's disease.

AIM: Surgical management of colonic Crohn's disease (CD) is still unclear because different procedures can be adopted. The choice of operation is dependent on the involvement of colonic disease but the advantages and disadvantages of the extent of resection are still debated. METHOD: The aim of the present study was to evaluate the differences in short-term and long-term outcomes of adult patients with colonic CD who underwent either subtotal colectomy and ileorectal anastomosis (STC) or segmental colectomy (SC) or total proctocolectomy and end ileostomy (TPC). Studies published between 1984 and 2012 including comparisons of STC vs SC and of STC vs TPC were selected. The study end-points were overall and surgical recurrence, postoperative morbidity and incidence of permanent stoma. Fixed effect models were used to evaluate the study outcomes. RESULTS: Eleven studies, consisting of a total of 1436 patients (510 STC, 500 SC and 426 TPC), were included. Analysis of the data showed no significant difference between STC and SC in terms of overall and surgical recurrence of CD. In contrast, STC showed a higher risk of overall and surgical recurrence of CD than TPC (OR 3.53, 95% CI 2.45-5.10, P < 0.0001; OR 3.52, 95% CI 2.27-5.44, P < 0.0001, respectively). SC had a higher risk of postoperative complications compared to STC, and STC had a lower risk of complications than TPC (OR 2.84, 95% CI 1.16-6.96, P < 0.02; OR 0.19, 95% CI 0.09-0.38, P < 0.0001, respectively). SC resulted in a lower risk of permanent stoma than STC (OR 0.52, 95% CI 0.35-0.77). CONCLUSION: All three procedures were equally effective as treatment options for colonic CD and the choice of operation remains intrinsically dependent on the extent of colonic disease. However, patients in the TPC group showed a lower recurrence risk than those in the STC group. Moreover, SC had a higher risk of postoperative complications but a lower risk of permanent stoma. These data should be taken into account when deciding surgical strategies and when informing patients about postoperative risks.

Impact of esophagectomy for cancer on patients' occupational status.

BACKGROUND: The aim of our study was to investigate the impact of esophagectomy for cancer on patients' occupational status. METHODS: All 109 consecutive patients presenting with esophageal cancer to the Surgical Oncology Unit of the Veneto Institute of Oncology Padua (Italy) between November 1, 2009 and March 15, 2012, were included in the study. Information on occupational status at diagnosis and at 1 year after esophagectomy was retrieved. Health-related quality of life was evaluated at discharge after surgery using selected aspects of the EORTC QLQ-C30 questionnaire. Non parametric statistics were used. RESULTS: Sixty-one patients (49.6%) were active workers at diagnosis and 50 of them (82.0%) underwent esophagectomy. Eighteen active workers (18/50, 36.0%) quit their job within one year from esophagectomy. They received jejunostomy more often than patients still working after surgery (50.0% vs. 18.8%, respectively; p = 0.03) and reported lower social functioning at discharge (mean ± SD 63.6 ± 16.4 vs. 80.2 ± 25.6 in others, p = 0.02). Multivariable analysis identified jejunostomy as independent predictor of job-quitting at 1 year after esophagectomy (p = 0.03; OR 4.75, 95% C.I. 1.11-20.39) but not social functioning at discharge (p = 0.21). CONCLUSIONS: Patients should be informed that they may experience social and work disability due to cancer treatment and adequate interventions of return-to-work support should be provided. Adequate welfare strategy should be implemented for esophageal cancer survivors, enhancing their role competences and contributing to precision care medicine.

Hybrid minimally invasive esophagectomy for cancer: impact on postoperative inflammatory and nutritional status.

The purpose of this case-control study was to evaluate the impact of hybrid minimally invasive esophagectomy for cancer on surgical stress response and nutritional status. All 34 consecutive patients undergoing hybrid minimally invasive esophagectomy for cancer at our surgical unit between 2008 and 2013 were retrospectively compared with 34 patients undergoing esophagectomy with open gastric tubulization (open), matched for neoadjuvant therapy, pathological stage, gender and age. Demographic data, tumor features and postoperative course (including quality of life and systemic inflammatory and nutritional status) were compared. Postoperative course was similar in terms of complication rate. Length of stay in intensive care unit was shorter in patients undergoing hybrid minimally invasive esophagectomy (P = 0.002). In the first postoperative day, patients undergoing hybrid minimally invasive esophagectomy had lower C-reactive protein levels (P = 0.001) and white cell blood count (P = 0.05), and higher albumin serum level (P = 0.001). In this group, albumin remained higher also at third (P = 0.06) and seventh (P = 0.008) postoperative day, and C-reactive protein resulted lower at third post day (P = 0.04). Hybrid minimally invasive esophagectomy significantly improved the systemic inflammatory and catabolic response to surgical trauma, contributing to a shorter length of stay in intensive care unit.

Esophagectomy in elderly patients: which is the best prognostic score?

Our study aimed to identify the best prognostic score for fitness for surgery and postoperative morbidity in elderly patients. A prospectively collected database of a consecutive series of patients with esophageal cancer evaluated for possible esophagectomy at our unit was analyzed. Fitness for surgery and postoperative morbidity were used as measures of outcome. The performances of the Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity (POSSUM) score, the Charlson Comorbidity Index, the age-related Charlson Comorbidity Index (ACCI), the American Society of Anesthesiologists scale and the prognostic nutritional index (PNI) were evaluated in elderly patients. Discrimination was measured with receiver operating characteristics curve analysis; calibration was assessed by the Hosmer-Lemeshow goodness-of-fit test. Age did not result a significant predictor for postoperative complications. In elderly patients, ACCI predicted the judgment of the multidisciplinary team about fitness for surgery with the best discrimination (C-index = 0.94). PNI had the best discrimination for postoperative complications (C-index = 0.71) in the elderly group. ACCI best predicted the fitness for surgery in elderly patients. In elderly patients, the most discriminative prognostic score for postoperative complication was PNI, which could be used at admission for surgery to correctly inform patients about their risk and, possibly, to take extra precaution in case of high risk.

Modified Dental Anxiety Scale: validation of the Italian version.

AIM: Anxiety is a relevant problem in dental practice. The Modified Dental Anxiety Scale (MDAS) is a brief, simple questionnaire consisting of five questions with a total score ranging from 5 to 25, the Italian version of which is not available yet. The aim of the study was to provide an Italian version of the MDAS and check its reliability in oral surgery, which is a major cause of dental anxiety due to the expected perception of pain and suffering. METHODS: The Italian version of the test was administered to 230 patients (98 male and 132 female patients, ages 14-88 years) undergoing oral surgery. Further recorded data were: American Society of Anaesthesiologists physical status classification (ASA-PS), frequency of visiting the dentist and any previous distressing experiences in dental or medical setting. RESULTS: The internal consistency of the test was high, with a Cronbach's alpha=0.92. The MDAS score was significantly higher in females (P<0.0001) and in patients with previous distressing experiences in medical and/or dental settings (P<0.0001); the correlation with age (P=0.01) and frequency on visiting the dentist (P=0.02) were also significant. CONCLUSIONS: The patients' selection (oral surgery only) may be a limit of the study, which might not provide an estimation of anxiety prevalence in the general dental population; however our result agree with those of studies performed in other Countries in the generic population, suggesting the absence of major differences with respect to the surgical setting and show the reliability and manageability of the Italian version of MDAS.

Modified dental anxiety scale: validation of the italian version.

AIM: Anxiety is a relevant problem in dental practice. The Modified Dental Anxiety Scale (MDAS) is a brief, simple questionnaire consisting of five questions with a total score ranging from 5 to 25, the Italian version of which is not available yet. The aim of the study was to provide an Italian version of the MDAS and check its reliability in oral surgery, which is a major cause of dental anxiety due to the expected perception of pain and suffering. METHODS: The Italian version of the test was administered to 230 patients (98 male and 132 female patients, ages 14-88 years) undergoing oral surgery. Further recorded data were: American Society of Anaesthesiologists physical status classification (ASA-PS), frequency of visiting the dentist and any previous distressing experiences in dental or medical setting. RESULTS: The internal consistency of the test was high, with a Cronbach's alpha=0.92. The MDAS score was significantly higher in females (p<0.0001) and in patients with previous distressing experiences in medical and/or dental settings (p<0.0001); the correlation with age (p=0.01) and frequency on visiting the dentist (p=0.02) were also significant. CONCLUSIONS: The patients' selection (oral surgery only) may be a limit of the study, which might not provide an estimation of anxiety prevalence in the general dental population; however our result agree with those of studies performed in other Countries in the generic population, suggesting the absence of major differences with respect to the surgical setting and show the reliability and manageability of the Italian version of MDAS.

Postoperative outcome after oesophagectomy for cancer: Nutritional status is the missing ring in the current prognostic scores.

BACKGROUND: Several prognostic scores were designed in order to estimate the risk of postoperative adverse events. None of them includes a component directly associated to the nutritional status. The aims of the study were the evaluation of performance of risk-adjusted models for early outcomes after oesophagectomy and to develop a score for severe complication prediction with special consideration regarding nutritional status. METHODS: A comparison of POSSUM and Charlson score and their derivates, ASA, Lagarde score and nutritional index (PNI) was performed on 167 patients undergoing oesophagectomy for cancer. A logistic regression model was also estimated to obtain a new prognostic score for severe morbidity prediction. RESULTS: Overall morbidity was 35.3% (59 cases), severe complications (grade III-V of Clavien-Dindo classification) occurred in 20 cases. Discrimination was poor for all the scores. Multivariable analysis identified pulse, connective tissue disease, PNI and potassium as independent predictors of severe morbidity. This model showed good discrimination and calibration. Internal validation using standard bootstrapping techniques confirmed the good performance. CONCLUSIONS: Nutrition could be an independent risk factor for major complications and a nutritional status coefficient could be included in current prognostic scores to improve risk estimation of major postoperative complications after oesophagectomy for cancer.

Shorter myotomy on the gastric site (≤2.5 cm) provides adequate relief of dysphagia in achalasia patients.

The right length of the myotomy on the gastric side for esophageal achalasia is still a debated issue. We aimed to investigate the final outcome after classic myotomy (CM) as compared with a longer myotomy on the gastric side (LM) in two cohorts of achalasia patients. Forty-four achalasia patients who underwent laparoscopic Heller-Dor were considered; patients with a sigmoid-shaped esophagus were excluded. Symptoms were scored using a detailed questionnaire for dysphagia, regurgitation, and chest pain. Barium swallow, endoscopy, and esophageal manometry were performed before and 6 months after the surgical treatment; 24-hour pH-monitoring was also performed 6 months after the procedure. CM was defined as a gastric myotomy length in the range of 1.5-2.0 cm, while LM was 2.5-3 cm in length. The surgical treatment (CM or LM) was adopted in two consecutive cohorts. Treatment failure was defined as a postoperative symptom score >10th percentile of the preoperative score (i.e. >8). Of the 44 patients representing the study population, 20 had CM and 24 had LM. The patients' demographic and clinical parameters (age, sex, symptom score, duration of symptoms, esophageal diameter, and manometric pattern) were similar in the two groups. The median follow up was 24 months (interquartile range 12-39). One patient in each group was classified as a treatment failure. After the treatment, there was a significant decrease in both groups' symptom score, and resting and residual pressure (P < 0.01), with no statistically significant differences between the two groups in terms of postoperative symptom score, resting and residual pressure, or total and abdominal lower esophageal sphincter length and esophageal diameter. Extending the length of the myotomy on the gastric side does not seem to change the final outcome of the laparoscopic Heller-Dor procedure.

Everolimus associated with low-dose calcineurin inhibitors, an option in kidney transplant recipients of very old donors.

BACKGROUND: Despite potential renal and cardiovascular advantages of proliferation signal inhibitors, their de novo use in kidney transplantation (KT) from elderly donors (ED) is poorly documented. We retrospectively analyzed two consecutive cohorts of KT from ED: low-dose extended-release tacrolimus (Tac) was used from 2010 to 2012 and cyclosporine (Csa) was used from 2008 to 2010. METHODS: Associated maintenance drugs were everolimus (Eve) and steroids. Outcomes were compared between groups over a 12-month follow-up. Fifty-six patients were analyzed in the Tac-Eve group and 54 in the Csa-Eve group. RESULTS: There were no significant differences at baseline with the exception of older donors age in the Tac-Eve cohort (74 vs 71 years, P = .002). There were no deaths, primary non functions, or graft losses. Eight (14%) Tac-Eve and 15 (28%) Csa-Eve patients had delayed graft function (P = .10). Renal function was fairly stable over time (median cGFR 36-49 mL/min and 51-55 mL/min in single kidney transplantation and dual kidney transplantation patients, respectively) with no significant differences between groups at month 12. Surgical complications were infrequent and observed mostly in dual kidney transplantation recipients. Thirty-nine (70%) and 30 (56%) patients remained under their initial Tac-Eve or Csa-Eve regimen, respectively. CONCLUSIONS: Induction with Thymoglobuline and maintenance with Eve and low-dose extended-release Tac and steroids is safe and effective in renal transplant from ED.

Validation of visual analogue scale for anxiety (VAS-A) in preanesthesia evaluation.

BACKGROUND: Anxiety is a relevant but still underscored perioperative problem. The Visual Analogue Scale for Anxiety (VAS-A) seems to be effective, fast and manageable, but has not been fully validated yet. The aim of this study is to validate VAS-A comparing it to, Corah's Dental Anxiety Scale (CDAS) Spielberger's State Trait Anxiety Inventory (STAI) and Beck Depression Inventory (BDI). METHODS: One hundred consecutive patients (38 males and 62 females, median age 49 years) submitted to oral surgery filled out the VAS-A, CDAS, STAI forms Y1 and Y2, and BDI at preoperative examination; the order of administration of tests was randomized. RESULTS: VAS-A score was significantly correlated to CDAS (P<0.0001), STAI-Y1 (P<0.0001), STAI-Y2 (P<0.002) but not to BDI (P=0.18). ROC curve analysis suggested VAS-A equal to 46 mm as threshold for anxiety when using STAI Y1 equal to 40 as reference cutoff. CONCLUSION: Our study confirms that VAS-A is a reliable indicator of preoperative anxiety and may detect patients with depressive symptoms also. Values of VAS-A around 50 mm are a reliable threshold for a clinically meaningful level of preoperative anxiety.

Efficacy of INSURE during nasal CPAP in preterm infants with respiratory distress syndrome.

AIM: INSURE (INtubation, SURfactant, Extubation) is a proven complement of nasal CPAP (nCPAP) for respiratory distress syndrome (RDS) treatment of preterm infants. Early administration is characterized by greater success. We aimed to determine the efficacy and failure or other respiratory outcomes of INSURE administration during nasal continous positive airway pressure (nCPAP) treatment of RDS. METHODS: Among 824 premature infants neonatal intensive care unit (NICU) admitted at Padua University Hospital during 2007-2009, 209 (25.4%) were managed by surfactant replacement (200 mg/kg, Curosurf®) if required >45% oxygen ("rescue" treatment), including 42 (20.1%) during nCPAP. Each premature infant treated with INSURE during nasal CPAP was compared to 2 consecutive control infants treated with surfactant during mechanical ventilation, matched for antenatal steroids, delivery route, gestational age, and sex. RESULTS: Infants with RDS, treated with nCPAP and INSURE-complement (N.=25), were comparable in Apgar score, need of PPV at birth, birth weight, pre-surfactant FiO2 and timing of surfactant replacement to controls. However, nCPAP and INSURE-complement was superior in terms both of oxygenation, evaluated as post-treatment FiO2 (Median, [IQR], 26 [21-40] vs. 21 [21-29]; P=0.03) and (a-A) pO2 (0.48 [0.45-0.60] vs. 0.58 [0.53-0.72]; P=0.03). The improved oxygenation was sustained over the following days. In addition, premature infants treated with nCPAP and INSURE-complement developed less respiratory co-morbidities, including pneumothorax, borncopulmonary disease (BPD), and BPD and death (P=0.04). CONCLUSION: INSURE-complement of nasal CPAP has a superior efficacy in terms of oxygenation improvement, maintenance of optimal oxygenation, and reduction of respiratory comorbidities respect to "rescue" surfactant administration during mechanical ventilation.

Acupuncture versus valproic acid in the prophylaxis of migraine without aura: a prospective controlled study.

BACKGROUND: The pharmacologic treatment of migraine still remains below the expectations. The aim of this study is to compare the effectiveness of traditional acupuncture and valproic acid in migraine prophylaxis. METHODS: A prospective, controlled study was performed in 100 patients affected by migraine without aura lasting for over one year. The patients were stratified for sex and randomly divided into two groups of 50 patients each. Patients belonging to Group A (acupuncture) were submitted to 20 sessions of acupuncture, while patients belonging to Group V valproate) were administered Valproic acid (Depakin Chrono®) at a dose of 600 mg/day; 10 mg Rizatriptan wafers were allowed as needed to treat the attacks. The Midas Index (MI) and pain intensity (PI, by VAS) were recorded before treatment (T0), at three (T1) and six (T2) months; a six-point scale Pain Relief score (PRS), the Rizatriptan intake and adverse events were recorded at T1 and T2. RESULTS: Eighty-two out of 100 patients completed the study (9 dropouts in each group). In both groups the MI improved at T1 and T2 (P<0.0001). Pain intensity was better at T1 in group V (P<0.0001), but PI and PRS (P=0.02) as well as rizatriptan intake (P=0.001) were better in group A at T2. The rate of adverse events was 47.8% in group V and 0% in group A. CONCLUSION: Our data show a lower pain intensity and lower Rizatriptan intake at six-months follow-up with no adverse events in acupuncture patients compared to those treated with valproic acid.

Toward the validation of visual analogue scale for anxiety.

Anxiety is a relevant problem in dental practice. The Visual Analogue Scale for Anxiety (VAS-A), introduced in dentistry in 1988, has not yet been validated in large series. The aim of this study is to check VAS-A effectiveness in more than 1000 patients submitted to implantology. The VAS-A and the Dental Anxiety Scale (DAS) were administered preoperatively to 1114 patients (459 males and 655 females, age 54.7 ± 13.1 years). Statistical analysis was conducted with Pearson correlation coefficient, the receiver operating characteristic (ROC) curve, and McNemar tests. A close correlation between DAS and VAS-A was found (r  =  0.57, P < .0001); the VAS-A thresholds of dental anxiety and phobia were 5.1 and 7.0 cm, respectively. Despite a significant concordance of tests in 800 cases (72%), disagreement was found in the remaining 314 cases (28%), and low DAS was associated with high VAS-A (230 cases) or vice versa (84 cases). Our study confirms that VAS-A is a simple, sensitive, fast, and reliable tool in dental anxiety assessment. The rate of disagreement between VAS-A and DAS is probably due to different test sensitivities to different components of dental anxiety. VAS-A can be used effectively in the assessment of dental patients, using the values of 5.1 cm and 7.0 cm as cutoff values for anxiety and phobia, respectively.