The Impact of Teduglutide on Real-Life Health Care Costs in Children with Short Bowel Syndrome.

OBJECTIVES: To analyze the real-life health care costs of home parenteral nutrition (HPN) in children with short bowel syndrome with intestinal failure (SBS-IF) before and after treatment with teduglutide, and to compare those with costs of children with SBS-IF not treated with teduglutide. STUDY DESIGN: All consecutive children with SBS-IF on HPN treated with subcutaneous teduglutide starting from 2018 through 2020 in a tertiary French referral center were retrospectively included. These patients were matched to children with SBS-IF on HPN followed during the same 3-year period who were eligible for the teduglutide but were not treated. HPN direct medical costs included home-care charges, HPN bags, hospital admissions, and teduglutide. A comparison of costs before/after treatment and between patients treated/not treated was performed. RESULTS: Sixty children were included: 30 (50%) were treated with teduglutide and 30 (50%) were untreated. In the treated group, the median total costs of HPN significantly decreased after 1 (P < .001) and 2 years of treatment (P < .001) from 59 454 euros/year/patient to 43 885 euros/year/patient and 34 973 euros/year/patient, respectively. When we compared patients treated and not treated, the total HPN costs/year/patient were similar at baseline (P = .6) but were significantly lower in the teduglutide-treated group after 1 (P = .006) and 2 years of treatment (P < .001). When we added the cost of teduglutide into the analysis, the total cost increased significantly in the treated group and remained much greater even after modeling a reduction in the cost of the drug to one-third the present cost and PN weaning (P < .001). CONCLUSIONS: Treatment with teduglutide is associated with a significant reduction in the annual costs of HPN but still remains expensive because of the drug itself. Finding cost-saving strategies is essential.

Salivary Biomarkers Analysis and Neurobehavioral Assessment in Nurses Working Rotation Shifts: A Pilot Study.

Currently, about one in five workers is employed in night shift work in Europe. Shift work including nighttime hours is essential in several activities, especially the healthcare sector. Importantly, night working may be associated with the occurrence of sleep disorders or work-related stress, both potentially augmenting the risk of errors and accidents at work. This study aims to examine the presence of neurobehavioral alterations that can be a consequence of shift working and concurrent misalignment of the sleep times and circadian rhythms. Nurses (n = 102) employed at a University Hospital located in North-Eastern Sicily, Italy, voluntarily participated in this pilot study. During medical surveillance, morning and evening salivary samples were collected, and seven psychodiagnostics questionnaires were administered to all the subjects. On one hand, the salivary levels of stress-related biomarkers (cortisol and alpha-amylase) and a circadian biomarker (melatonin) were evaluated. On the other hand, several neurobehavioral features were assessed, including depression, anxiety, work-related, and sleep issues. Interestingly, a positive relationship between salivary morning cortisol and depression scale, as well as a negative relationship between salivary morning alpha-amylase and work ability scale, were observed. Based on these results, the integration of subjective questionnaire outcomes and objective salivary biomarker quantification can help to identify workers with increased susceptibility to developing neurobehavioral alterations. This approach may contribute to ameliorating preventive strategies towards sensitive categories, such as nurses working rotation shifts.

Willingness to Pay a Higher Price for Pork Obtained Using Animal-Friendly Raising Techniques: A Consumers' Opinion Survey.

In Italy, the consumption of pork meat is increasing, despite consumers' attitudes being addressed toward a greater sensitivity about animal welfare and its link with safe food. Considering the relatively high animal welfare standards and the divergence in public interest in farm animal welfare and ethical issues, the objective of this study-in continuation of our previous paper relating to consumer behavior and preferences in welfare-friendly pork breeding-was to investigate habits of pork consumers regarding pig welfare, principally evaluating their willingness to pay (WTP) a higher price for pork obtained using raising techniques with an approach based on animal welfare. An ad hoc questionnaire-based survey was submitted to consumers (n = 404) in Messina province, Italy. Results suggest that 47% of consumers were willing to pay an additional price for pork from farms that apply specific animal welfare standards. Positive correlations were between WTP and farming techniques (p = 0.001), organic farming methods (p = 0.001), and farms in which animal welfare is taken care of and guaranteed (p < 0.001). These findings suggest that consumers intend to pay a higher price for pork, like other animal products obtained using animal-friendly raising techniques. The sensitivity to the animal welfare of a single human being may influence consumers' attitudes toward pork consumption.

Long-term predictivity of early neurological assessment and developmental trajectories in low-risk preterm infants.

Prematurity represents 10.6% of all births, and although preterm infants usually show adequate neurodevelopmental outcomes, some may develop significant and long-lasting neurological sequelae. Many studies have analyzed predictive factors for developing severe neurodevelopmental impairments (cerebral palsy, other motor and socio-relational disorders such as autism). In this study, 148 preterm infants were enrolled to investigate the neurodevelopmental trajectories in a population of low-risk premature infants using standardized assessment methods. Significant correlations were found between the general movements, the Hammersmith Infant Neurological Examination, and the Griffiths Mental and Development Scales. Moreover, this study showed their validity and predictivity for adverse neurodevelopmental outcomes even in low-risk infants.

Prospective assessment of liver stiffness by shear wave elastography in childhood obesity: a pilot study.

PURPOSE: The increased incidence of childhood obesity and related non-alcoholic fatty liver disease (NAFLD) has determined the need to identify a non-invasive technique to diagnose and monitor NAFLD. Two-dimensional shear wave elastography (2D-SWE) has emerged as a reliable, non-invasive, tool to evaluate liver tissue elasticity in clinical practice. Aims of this study were to longitudinally evaluate 2D-SWE changes in relation to weight loss, metabolic profile, and body composition modifications and to investigate the correlation between 2D-SWE variation and clinical and biochemical indices of cardio-metabolic risk in obese children. METHODS: Thirty-three children underwent anthropometric, bioimpedenziometric, fasting biochemical assessments, ultrasound, and SWE evaluations, at baseline (V0) and after a 12-months of follow-up (V12). Diet and physical activity programs have been prescribed to all patients according to European Society of Endocrinology and Pediatric Endocrine Society recommendations. Adherence to the prescribed diet and physical activity program was checked every 3 months during the 12-month of follow-up. Variation of all parameters was evaluated in intragroup and intergroup comparison analysis in children, who had not lost weight (Group A) and those who had lost weight (Group B) at V12. Study population was also analyzed dividing it into two groups with respect to 2D-SWE liver elasticity value ≤10.6 kPa or >10.6 kPa. RESULTS: A significant reduction of mean 2D-SWE value was demonstrated both in the entire cohort (p = 0.002) and in Group B children (p = 0.004). Intragroup comparison analysis, between V0 and V12, documented a significant decrease of 2D-SWE and BMI SDS and a significant improvement of metabolic profile (decrease of HOMA-IR, HbA1c, oral glucose tolerance test 120-min glucose and insulin, triglycerides, triglycerides/HDL-ratio, transaminases, uric acid, and increase of Matsuda-index and HDL) in children of Group B but not in those of Group A. Intergroup comparison analysis showed significant differences for BMI, BMI SDS, transaminases and several parameters of glucose and lipid metabolism, between Group A and Group B children after 12-months of follow-up. No significant differences were documented with regard to clinical and biochemical variables by dividing the population in accordance with the 2D-SWE cut-off of 10.6 kPa. CONCLUSIONS: These results suggested a relation between weight loss, metabolic profile improvement and 2D-SWE value reduction. SWE could play a significant role in the non-invasive assessment of NAFLD in children and adolescents with obesity.

A Clinical Bridge between Family Caregivers and Older Adults: The Contribution of Patients' Frailty and Optimism on Caregiver Burden.

The association between caregiver burden and the physical frailty of older adults has been the object of previous studies. The contribution of patients' dispositional optimism on caregiver burden is a poorly investigated topic. The present study aimed at investigating whether older adults' multidimensional frailty and optimism might contribute to the burden of their family caregivers. The Caregiver Burden Inventory was used to measure the care-related burden of caregivers. The multidimensional frailty status of each patient was evaluated by calculating a frailty index, and the revised Life Orientation Test was used to evaluate patients' dispositional optimism. The study involved eighty family caregivers (mean age 64.28 ± 8.6) and eighty older patients (mean age 80.45 ± 7.13). Our results showed that higher frailty status and lower levels of optimism among patients were significantly associated with higher levels of overall burden and higher burden related to the restriction of personal time among caregivers. Patients' frailty was additionally associated with caregivers' greater feelings of failure, physical stress, role conflicts, and embarrassment. Understanding the close connection between patient-related factors and the burden of caregivers appears to be an actual challenge with significant clinical, social, and public health implications.

Welfare assessment in intensive and semi-intensive dairy cattle management system in Sicily.

The present study aimed to compare the welfare of dairy cows kept in two traditional husbandry systems (semi-intensive and intensive farming) in south-eastern Sicily. A total of 18 dairy farms (nine semi-intensive and nine intensive) were evaluated with a multicriteria system adapted for Sicilian conditions and obtained simplifying the model of the European Food Safety Authority (EFSA). Values of welfare measures, collected by inspections of the farms (general well-being indicators, ventilation system, resting areas [cubicles or bedding], flooring, milking parlours and waiting area, manger and watering equipment), and those of health categories (cases of abortions, hypocalcemia, displacement of abomasum, acidosis/ketosis, enteritis, hoof problems, and mastitis) obtained through the farm records, were compared using Mann-Whitney and Chi-squared tests, respectively. Data showed significant differences (p ≤ .05) about the variables related to welfare categories such as housing ventilation system, resting area, manger, and water equipment that were better in the semi-intensive system than the intensive system. No significant differences were observed about the variables related to health indicators. The results demonstrated that in Sicily the semi-intensive farm is better than the intensive to satisfy the conditions of animal welfare.

Experience of an Italian Hospital Claims Management Committee: A tool for extrajudicial litigations resolution.

Litigation related to medical liability has a great impact on Italian healthcare expenditure. Recently, many Italian Regions have adopted a "self-insurance system" and, in Sicilian Hospitals, were established the Claims Management Committees (CMC) to provide the direct management of claims. Here the experience of a Sicilian University Hospital CMC was described to analyze the claims features and their outcomes providing evidence on CMC usefulness. The analysis involved claims for compensation received during 4 years, using data obtained by a retrospective analysis of claims database created by Forensic Medicine Service. Claims data, obtained from the insurance broker, were used to perform the statistical comparison. During the examined period a total of 377 claims were received by CMC, respectively 63.6% for professional liability and 36.4% for other causes (damages not related to medical malpractice). The prevalence of complaints about malpractice regarded surgery. The CMC had expressed an opinion on 120 claims related to malpractice with the percentages of admission or rejection of liability respectively of 55% and 45%. The statistical analysis revealed a greater number of lawsuits in the Insurance system and, moreover, the CMC higher probability to reach the amicable settlement of litigations. CMC provides specific data on claims trend and economic expenditure, demonstrating its usefulness for analysis and monitoring the causes of patients/people damage. It is a tool for medical malpractice risk assessment and prevention. It can encourage the amicable settlement and prevention of civil action. It seems to be an efficient system to reduce the health liability costs.

Diagnostic Yield of 2 Strategies for Adult Celiac Disease Identification in Primary Care.

GOALS: To compare the diagnostic yield and cost-consequences of 2 strategies, screening regardless of symptoms versus case finding (CF), using a point-of-care test (POCT), for the detection of celiac disease (CD) in primary care, to bridge the diagnostic gap of CD in adults. MATERIALS AND METHODS: All subjects under 75 years of age who consecutively went to their general practitioners' offices were offered POCT for anti-transglutaminase immunoglobulin A antibodies. The POCT was performed on all subjects who agreed, and then a systematic search for symptoms or conditions associated with higher risk for CD was performed, immediately after the test but before knowing the test results. The 2 resulting groups were: (a) POCT positive and (b) symptomatic subject at CF. Subjects were defined as symptomatic at CF in the presence of 1 or more symptoms. All POCT-positive or symptomatic subjects at CF were referred to the CD Centers for confirmation of CD. Data on resource consumption were gathered from patients' charts. Cost of examinations, and diagnostic and laboratory tests were estimated with regional outpatient tariffs (Sicily), and a price of &OV0556;2.5 was used for each POCT. RESULTS: Of a total of 2197 subjects who agreed to participate in the study, 36 (1.6%) and 671 (30.5%) were POCT positive and symptomatic at CF, respectively. The yield from the screening and CF was 5 new celiac patients. The total cost and mean cost for each new CD case were &OV0556;7497.35 and &OV0556;1499.47 for the POCT screening strategy, and &OV0556;9855.14 and &OV0556;1971.03 for the CF strategy, respectively. Assuming consecutive use of both strategies, performing POCT only in symptomatic subjects at CF, the calculated yield would be 4 new diagnoses with a total cost of &OV0556;2345.84 and a mean cost of &OV0556;586.46 for each newly diagnosed patient. Only 1 patient was celiac despite a negative POCT. CONCLUSIONS: Testing symptomatic subjects at CF only by POCT seems the most cost-effective strategy to bridge the diagnostic gap of adult CD in primary care.

Intestinal gas and liver steatosis: a casual association? A prospective multicentre assessment.

BACKGROUND & AIMS: Excessive intestinal gas and liver steatosis are frequent sonographic findings. Both of these appear to be caused by variations of the gut microflora. We assessed the relationship between ultrasonographic detection of intestinal gas and liver steatosis. METHODS: This study included 204 consecutive patients (99 male; mean age 53.0 ± 15.6 years), who underwent ultrasonography for abdominal complaints or follow-up of benign lesions. Body mass index, biochemical liver markers, sonographic presence of liver steatosis and/or degree of intestinal gas interfering with the examination were collected. Both sonographic findings were assessed based on standardized criteria. The association between liver steatosis and intestinal gas was evaluated by means of univariate and multivariate analyses. RESULTS: Eighty (39.2%) of patients showed moderate to large amounts of gas preventing an accurate evaluation of the liver or pancreas and 90 (44.1%) had liver steatosis. A significant correlation between the degree of intestinal gas and liver steatosis both in obese (r=.603; P<.001) and in nonobese patients (r=.555; P<.001) was found. Univariate analysis showed that intestinal gas, body mass index, aspartate transaminase, alanine transaminase, gamma-GT, age and sex were predictors of liver steatosis; only intestinal gas (OR 7.4; 95% CI 3.4-16.1) and body mass index (OR; 1.4, 95% CI 1.2-1.5), however, were independent predictors at multivariate analysis. The presence of excessive gas was also significantly correlated with liver steatosis coupled with elevated ALT (P = .001). CONCLUSION: This study shows a significant correlation between excessive intestinal gas and liver steatosis. The reasons of this finding and its clinical implications remain to be defined.

Indications of newer and older anti-epileptic drug use: findings from a southern Italian general practice setting from 2005-2011.

AIMS: The aim of the study was to analyze the prescribing pattern of both newer and older AEDs. METHODS: A population of almost 150 000 individuals registered with 123 general practitioners was included in this study. Patients who received at least one AED prescription over 2005-2011 were identified. The 1 year prevalence and cumulative incidence of AED use, by drug class and individual drug, were calculated over the study period. Potential predictors of starting therapy with newer AEDs were also investigated. RESULTS: The prevalence of use per 1000 inhabitants of older AEDs increased from 10.7 (95% CI10.1, 11.2) in 2005 to 13.0 (95% CI12.4, 13.6) in 2011, while the incidence remained stable. Newer AED incidence decreased from 9.4 (95% CI 8.9, 9.9) in 2005 to 7.0 (95% CI 6.6, 7.5) in 2011, with a peak of 15.5 (95% CI 14.8, 16.1) in 2006. Phenobarbital and valproic acid were the most commonly prescribed AEDs as starting therapy for epilepsy. Gabapentin and pregabalin accounted for most new pain-related prescriptions, while valproic acid and lamotrigine were increasingly used for mood disorders. Female gender (OR 1.36, 95% CI 1.20, 1.53), age ranging between 45-54 years (OR 1.39, 95% CI 1.16, 1.66) and pain as an indication (OR 16.7, 95% CI, 13.1, 21.2) were associated with newer AEDs starting therapy. CONCLUSIONS: Older AEDs were mainly used for epileptic and mood disorders, while newer drugs were preferred for neuropathic pain. Gender, age, indication of use and year of starting therapy influenced the choice of AED type. The decrease of newer AED use during 2007 is probably related to the restricted reimbursement criteria for gabapentin and pregabalin.

Assessment of liver stiffness in subjects affected by familial combined hyperlipidaemia with hepatic steatosis.

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of diseases ranging from simple steatosis to nonalcoholic steatohepatitis (NASH) and is associated with familial combined hyperlipidaemia (FCHL). Currently, the invasive liver biopsy is considered as the gold standard for evaluating liver fibrosis (LF); however, liver stiffness measurement (LSM) by transient elastography (TE) trough FibroScan device may be employed to estimate LF noninvasively. The aim of this study was to evaluate the prevalence of NAFLD in FCHL subjects and to analyse LSM with TE to better identify those individuals with a potential risk of liver disease progression. MATERIALS AND METHODS: Sixty subjects with FCHL (38 men, 22 women, mean age 46.4 +/- 10.9 years) were included in the study. We studied biochemical parameters including lipid profile, glucose, transaminase and insulin; blood pressure and waist circumference (WC) were measured; BMI and HOMA-index were calculated. Ultrasonography was performed to assess liver steatosis and carotid intima-media thickness (IMT). Liver fibrosis was measured by FibroScan. RESULTS: Patients were classified according to have no (group 0: 19%), mild (group 1: 32%) or moderate-severe (group 2: 49%) steatosis. No difference was found between group 0 and 1 concerning all study parameters. WC (P < 0.05), BMI (P < 0.05), glucose (P < 0.05), insulin (P < 0.001), HOMA-index (P < 0.001) and LSM (6.03 +/- 1.9 Kpa vs. 4.2 +/- 0.5 Kpa, P < 0.001) were significantly higher in group 2 than groups 1 and 0. Furthermore, LSM correlated with insulin (P < 0.05), glucose (P < 0.05), HOMA-index (P < 0.001), transaminase (P < 0.01) and liver steatosis (P < 0.001). Regression analysis showed that LSM (P < 0.001) and NAFLD (P < 0.01) is associated with HOMA-index; NAFLD is also associated with WC (P < 0.05). CONCLUSION: Our results suggest that in FCHL subjects, HOMA-index, an insulin resistance index, is strongly associated with liver steatosis and its progression. Furthermore, in these subjects, we propose the transient elastography to identify and follow up patients for the progression of hepatic disease.