Monitoring oral iron therapy in children with iron deficiency anemia: an observational, prospective, multicenter study of AIEOP patients (Associazione Italiana Emato-Oncologia Pediatrica).

Oral ferrous salts are standard treatment for children with iron deficiency anemia (IDA). The objective of our study was to monitor oral iron therapy in children, aged 3 months-12 years, with IDA. We prospectively collected clinical and hematological data of children with IDA, from 15 AIEOP (Associazione Italiana di Ematologia ed. Oncologia Pediatrica) centers. Response was measured by the increase of Hb from baseline. Of the 107 analyzed patients, 18 received ferrous gluconate/sulfate 2 mg/kg (ferrous 2), 7 ferrous gluconate/sulfate 4 mg/kg (ferrous 4), 7 ferric iron salts 2 mg/kg (ferric), 62 bis-glycinate iron 0.45 mg/kg (glycinate), and 13 liposomal iron 0.7-1.4 mg/kg (liposomal). Increase in reticulocytes was evident at 3 days, while Hb increase appeared at 2 weeks. Gain of Hb at 2 and 8 weeks revealed a higher median increase in both ferrous 2 and ferrous 4 groups. Gastro-intestinal side effects were reported in 16% (ferrous 2), 14% (ferrous 4), 6% (glycinate), and 0 (ferric and liposomal) patients. The reticulocyte counts significantly increased after 3 days from the start of oral iron supplementation. Bis-glycinate iron formulation had a good efficacy/safety profile and offers an acceptable alternative to ferrous iron preparations.

Hysteropexy with single-incision vaginal support system associated with a modified culdoplasty for enterocele prevention.

Our study assessed the safety and clinical outcomes of hysteropexy with a single-incision mesh associated with a modified culdoplasty, for the surgical management or prevention of enterocele, in women with pelvic organ prolapse (POP). We carried out a 1-year prospective single-cohort study, including 51 women with symptomatic, multi-compartmental POP. Anatomical outcome was assessed with a POP-Q system and the subjective outcomes were assessed using ICSQ-SF and PGI-I. One-year follow-up data were available for 48 out of 51 patients. The POP-Q cure rate was 91%, 83% of patients were satisfied or very satisfied (PGI-I ≤ 2). No major complications occurred; the most common minor complications were mesh erosion (6%) and pelvic pain (8%). Lower urinary tract dysfunctions arose in 16% of the patients. Anatomical prolapse recurrence (POP-Q stage ≥2) in anterior or apical compartments occurred in four patients (8%). No case of de novo prolapse occurred in the posterior compartment. None of the patients required further surgery for recurrent prolapse. This standardised procedure provided satisfactory 'restitutio ad integrum' of the vaginal anatomy and symptom relief.Impact statementWhat is already known on this subject? The post-surgical evidence of de novo prolapse in untreated compartments is well-known, especially in prosthetic surgery. The insertion of polypropylene mesh causes a vigorous support, consequently the forces on the pelvic floor are transmitted to the least consolidated vaginal compartment. A lack of simultaneous repair of all the segments involved in the POP increases the risk of surgical recurrence even in those areas that did not appear to be pre-operatively affected by the uterine descensus.What the results of this study add? Our prospective study showed that hysteropexy with a single-incision vaginal support system plus a modified culdoplasty was able to prevent the enterocele and the occurrence of prolapse in the posterior compartment, by closing the Douglas pouch and restoring the connection of the rectovaginal septum with the apical support.What the implications are of these findings for clinical practice and/or further research? This study may be relevant for clinicians in selecting the technique for pelvic floor surgery, and it may be of interest for researchers investigating the reasons for de novo occurrence of posterior segment prolapse.

Comparative analysis of the incidence of surgical site infections in patients with liver resection for colorectal hepatic metastases after neoadjuvant chemotherapy.

BACKGROUND: The aim of this study was to identify the incidence of surgical site infections (SSIs) and postoperative complications, as defined by the Clavien-Dindo classification, after hepatic resection for metastatic colorectal cancer in patients with and without associated neoadjuvant chemotherapy. METHODS: A total of 181 patients were studied retrospectively. Patients were divided into two groups: the first group comprised patients with associated neoadjuvant chemotherapeutic treatment for liver metastases with a latency time <8 wk and the second group comprised patients without associated neoadjuvant chemotherapy. RESULTS: Variables of duration of liver surgery, length of total hospital stay, and length of postoperative hospital stay seem to be correlated with SSIs and postoperative complications, P < 0.005 and P < 0.0001, respectively. Duration of surgery is a risk factor for SSIs, with an odds ratio of 1.15, and for complications according to the Clavien-Dindo classification, with an odds ratio of 1.35. CONCLUSIONS: Neoadjuvant chemotherapy was not a significant risk factor for SSIs, whereas the total length of hospital stay, length of postoperative hospital stay, and duration of surgery were independent predictors of SSIs and complications according to the Clavien-Dindo classification.

Cancer Prevention for Survivors: Incidence of Second Primary Cancers and Sex Differences-A Population-Based Study from an Italian Cancer Registry.

BACKGROUND: The number of cancer survivors continues to increase, thanks to advances in cancer diagnosis and treatment. Unfortunately, the incidence of a second primary cancer (SPC) is also increasing, but limited studies reporting incidence data are available regarding multiple cancers. This study presents our observations on multiple primary malignant cancers, the associations between sites, and the inherent sex differences. PATIENTS AND METHODS: We report the data, disaggregated by sex, concerning the SPCs that were recorded in the "Registro Tumori Integrato" (RTI) a population-based cancer registry in Sicily, Italy, as observed in the period from 2003 to 2017, in a total population of approximately 2,300,000. SPCs were divided into synchronous and metachronous cancers. The International Classification of Diseases for Oncology, third edition (ICD-O-3), was used for topographical and morphological classifications. Multiple primary cancers with multi-organ primitiveness were selected from the database of the RTI by extracting patients with more than one diagnosis. SPCs had different histology or morphology from the particular cancer that was considered to be the index cancer case. Multicenter or multifocal cancers, or metastases, were excluded. The percentages of cancer by sex and topography, the average age of incidence, and a breakdown by age were computed. RESULTS: Differences were observed between sexes in terms of incidence and site for SPCs. The most frequent SPC was skin cancer (20% of the SPCs observed). The associations among sites of multiple cancers are reported. CONCLUSION: There are many gaps in our knowledge of sex differences in cancer. The study of multiple primary cancers could bring more likely opportunities for evaluation of the cancer burden and trends that can be used to identify new research areas by population health programs, as well as for clinical researchers.

Factors Influencing Uptake of Breastfeeding: The Role of Early Promotion in the Maternity Hospital.

BACKGROUND: This study aimed to explore the prevalence of breastfeeding at birth points in Sicily and the relevance of the factors influencing the adoption of exclusive breastfeeding during hospitalization linked to childbirth. METHODS: A survey was conducted to monitor the prevalence of breastfeeding in seven out of nine facilities providing maternity services in the province of Catania (Sicily, Southern Italy) in the years 2016-2018. An online questionnaire was administered using an electronic tablet by the midwife to the mother after discharge. RESULTS: Women who had a higher educational qualification breastfed in a greater proportion (59.6%; odds ratio OR 0.60 for abandoning breastfeeding). Having had a caesarean section moderately impaired breastfeeding uptake, with an almost double chance of declining exclusive breastfeeding (OR = 1.74). Starting breastfeeding within 1 h from delivery showed a significant facilitating effect (OR = 0.58). Rooming-in had a strong facilitating effect on exclusive breastfeeding. A breastfeeding advocacy program was shown to protect from abandoning breastfeeding. CONCLUSIONS: It is important to offer in all hospitals the possibility and support for breastfeeding in the first moments after childbirth to increase the number of those who will then continue with exclusive breastfeeding.

Breastfeeding in Hospitals: Factors Influencing Maternal Choice in Italy.

Monitoring the prevalence of breastfeeding is one of the actions provided for in Italian National Health System. This study aims to observe the prevalence of breastfeeding in a representative set of birthing hospitals in the province of Catania, in Sicily, Italy, to assess the factors influencing women in their decisions to breastfeed during hospitalization after delivery. We conducted an observational study on 3813 questionnaires administered to mothers of newborns during their hospital stay from the years 2016 to 2018 in eight hospitals of various types. The average maternal age was 31.3 years ± 5.8. Sixty-nine percent of women did not attend a prenatal course. From childbirth to discharge, the percentage of women who breastfed was 88%, of whom 45% did exclusive breastfeeding. Only 35% of women who had a caesarean section adopted exclusive breastfeeding. In our experience, rooming-in was not associated with an increase in breastfeeding. We observed that both attendance to prenatal courses and the mother's education level played a minor role in influencing the mother's decision in breastfeeding A fairly high percentage of exclusive breastfeeding, 75%, was attained just in one hospital, where dedicated staff was deployed to encourage breastfeeding. The lowest percentage (12%) of exclusive breastfeeding was observed in a large private accredited health facility. Hospital presence of professionals trained in human lactation is a smart investment for society.

Availability of Real-World Data in Italy: A Tool to Navigate Regional Healthcare Utilization Databases.

The purpose of the study was to map and describe the healthcare utilization databases (HUDs) available in Italy's 19 regions and two autonomous provinces and develop a tool to navigate through them. A census of the HUDs covering the population of a single region/province and recording local-level data was conducted between January 2014 and October 2016. The characteristics of each HUD regarding the start year, data type and completeness, data management system (DMS), data protection procedures, and data quality control adopted were collected through interviews with the database managers using a standard questionnaire or directly from the website of the regional body managing them. Overall, 352 HUDs met the study criteria. The DMSs, anonymization procedures of personal identification data, and frequency of data quality control were fairly homogeneous within regions, whereas the number of HUDs, data availability, type of identification code, and anonymization procedures were considerably heterogeneous across regions. The study provides an updated inventory of the available regional HUDs in Italy and highlights the need for greater homogeneity across regions to improve comparability of health data from secondary sources. It could represent a reference model for other countries to provide information on the available HUDs and their features, enhancing epidemiological studies across countries.

Laparo-endoscopic rendez-vous versus sequential "delayed" approach in patients with choledocholithiasis.

BACKGROUND: The aim of this study was to compare the efficacy and safety of synchronous laparoscopic cholecystectomy with laparo-endoscopic rendez-vous (LRV) technique vs. sequential "delayed" approach with the main goal to compare the conversion rate and postoperative complications. METHODS: Patients diagnosed as having gallstones and CBD stones or sludge were enrolled in this study. From January 2013 to June 2015, 43 consecutive patients were submitted to the sequential treatment (ERCP prior to laparoscopic cholecystectomy) and the next consecutive 46 patients were submitted to undergo the rendez-vous technique. All endoscopic procedures in both groups were performed by the same endoscopist with the same technique. Data were collected on patient age, gender, latency operation time, duration of surgery, bilio-pancreatic events, hospital stay, mortality, conversion rate and postoperative complications. RESULTS: The overall mean age was 58 years-old (25-84 years) with 43 males (48.3%) and 46 females (51.7%). The conversion rate to open surgery was 11.6% in the "sequential group" vs. 2.2% in the LRV group with a P value 0.10. The reasons for conversion included in the first group unclear anatomy (in 2 patients) and severe adhesions (in the remnant 3 patient), and in the second group unclear anatomy (in one patient). No bilio-pancreatic events occurred in the waiting period for LC in the first group. No mortality was recorded in either group. Postoperative complications were seen in 7% of patients in the "sequential group" vs. 2.2% in the rendez-vous group (P value 0.35). CONCLUSIONS: LRV does not present real advantages in comparison to delayed sequential approach in terms of conversion rate and postoperative complications. However, these results require further elaboration in studies on large numbers of patients undergoing LRV approach.

Evaluation of a Topical Anti-inflammatory/Antifungal Combination Cream in Mild-to-moderate Facial Seborrheic Dermatitis: An Intra-subject Controlled Trial Examining Treated vs. Untreated Skin Utilizing Clinical Features and Erythema-directed Digital Photography.

OBJECTIVE: To evaluate if nonprescription topical agents may provide positive outcomes in the management of mild-to-moderate facial seborrheic dermatitis by reducing inflammation and scale production through clinical evaluation and erythema-directed digital photography. SETTING: Open-label, prospective, not-blinded, intra-patient, controlled, clinical trial (target area). PARTICIPANTS: Twenty adult subjects affected by mild-to-moderate facial seborrheic dermatitis were enrolled and instructed to apply the study cream two times daily, initially on a selected target area only for seven days. If the subject developed visible improvement, it was advised to extend the application to all facial affected area for 21 additional days. MEASUREMENT: Efficacy was evaluated by measuring the grade of erythema (by clinical examination and by erythema-directed digital photography), desquamation (by clinical examination), and pruritus (by subject-completed visual analog scale). Additionally, at the end of the protocol, a Physician Global Assessment was carried out. RESULTS: Eighteen subjects completed the study, whereas two subjects were lost to follow-up for nonadherence and personal reasons, respectively. Day 7 data from target areas showed a significant reduction in erythema. At the end of study, a significant improvement was recorded for erythema, desquamation, and pruritus compared to baseline. Physician Global Assessment showed improvement in 89 percent of patients, with a complete response in 56 percent of cases. CONCLUSION: These preliminary results indicate that the study cream may be a viable nonprescription therapeutic option for patients affected by facial seborrheic dermatitis able to determine early and significant improvement. This study also emphasizes the advantages of using an erythema-directed digital photography system for assisting in a simple, more accurate erythema severity grading and therapeutic monitoring in patients affected by seborrheic dermatitis.

A prospective study of pelvic floor dysfunctions related to delivery.

OBJECTIVE: To estimate the prevalence and impact on quality of life of urinary incontinence (UI) and anal incontinence (AI) three months after first delivery; to identify risk factors involved in UI or AI; to evaluate possible changes in sexual behaviour and anatomical modifications of pelvic floor after childbirth. STUDY DESIGN: A multicenter prospective study, in six Italian Ob/Gyn departments, of nulliparous women who delivered at term (37-42 weeks of gestation) between April and September 2005. A structured questionnaire investigated several maternal and obstetric variables. UI and AI were assessed by administration of the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and according to Wexner's Continence Grading Scale, at 2-3 days post-partum and at 3 months after delivery. Changes in sexual behaviour, and pelvic floor condition after delivery, were also recorded. Statistical analysis included comparison of means (Mann-Whitney or Student's t-test) and proportions (Chi-square test). Multiple logistic regression analysis was performed including variables that were significant in univariate comparisons. RESULTS: Of 960 enrolled women, 744 were evaluated 3 months after delivery and included in final analysis. The prevalences of UI and AI at that time were 21.6% and 16.3%, respectively. Onset of incontinence during pregnancy was an independent predictor for persistent UI (Odds Ratio (OR) 4.6, Confidence Interval (CI) 3.1-6.8, p<0.001) and AI (OR 3.6, CI 2.2-6.1, p<0.001). Family history of urinary or anal incontinence were respectively associated with UI (OR 2.6, CI 1.6-4.0, p<0.001) and AI (OR 2.4, CI 1.4-4.0, p<0.001) 3 months after delivery. Among obstetric factors, vaginal delivery was a strong risk factor for UI (OR 3.3, CI 2.0-5.3, p<0.001). The sexual score improved 3 months after delivery in 72.4% of women. Urogynaecological evaluation showed a significant association between grade 1-2 anterior prolapse, urethral hypermobility and UI. CONCLUSION: New onset of UI or AI during pregnancy, positive family history and vaginal delivery are independent risk factors for the persistence of symptoms of UI and AI in the early postpartum period. Adequate counselling and the implementation of targeted strategies to prevent or early identify these conditions are therefore mandatory to improve the patient's quality of life.

The selection of experts evaluating health projects for the EU Sixth Framework Program.

AIM: The Framework Programmes for Research and Technological Development (FP) are the European Union's funding programmes for research in Europe. The study analyses the features of external experts involved in evaluating the research proposals in FP6 (years 2003-2006) in the area of Life Sciences. SUBJECTS AND METHODS: Experts were analysed with respect to nationality, gender, organisational affiliation and rotation. The correlations between the number of experts by nationality and scientific research indicators were also explored. RESULT: Experts from 70 countries participated, with 70% coming from 10 countries. The gender composition was relatively stable, with approximately 30% of female experts. The majority of experts came from higher education establishments (51%) and 12% from industry. About 40% of experts participated in the evaluation process two or more times. The number of experts by nationality was linearly correlated with gross national income (r = 0.95, p < 0.0001), population (r = 0.91, p < 0.0001), and number of research publications in health sciences (r = 0.93, p < 0.0001). However, using multiple linear regression analysis, only gross national income had partial regression coefficients significantly different from zero (p = 0.017). The observed value of experts for Italy (312) and Belgium (155) were higher than predicted by this regression model (231 and 71 respectively). CONCLUSION: The expert panels involved were balanced with respect to nationalities, whereas the gender distribution was lower than the target. There was a satisfactory degree of rotation of experts between evaluation rounds. The percentage of experts from industry was lower than expected.

Growth hormone secretion in adult patients with thalassaemia.

BACKGROUND AND OBJECTIVES: Growth retardation and short stature are frequent clinical features of patients with beta-thalassaemia major. Dysfunction of the GH-IGF-1 axis has been described in many thalassaemic children and adolescents with short stature and reduced growth velocity. Several studies have demonstrated that recombinant GH treatment improves growth velocity in these patients, although response to the treatment is variable and not predictable. A reassessment of the GH-IGF-1 axis must be performed in young adults with childhood-onset GH deficiency (GHD), after attainment of final height, to select those who are candidates for replacement therapy as adults. To our knowledge there are no data available on retesting the GH-IGF-1 axis in adult thalassaemic patients with childhood-onset GHD. The aim of our study was to investigate GH secretion in adult thalassaemic patients with childhood-onset GHD. DESIGN: We reassessed GH secretion in a group of adult thalassaemic patients in whom partial GHD had been diagnosed during childhood. PATIENTS AND METHODS: We performed an arginine plus GH-releasing hormone (GHRH) stimulation test in 16 thalassaemic patients (10 males, six females) with a mean age of 24.8 +/- 3.6 years. The cut-off level for GH response was set at 9 microg/l, according to the literature. Ferritin, IGF-1, liver enzymes and lipid levels were also determined. RESULTS: We found persisting GHD in three patients, one patient had borderline values (GH peak = 10.4 microg/l), whereas the others had a normal response. These results are in accordance with the data on GH retesting in adult patients with idiopathic partial childhood-onset GHD. CONCLUSION: We conclude that GH status should be retested in adult thalassaemic patients with childhood-onset GHD. If the diagnosis of adult GHD is established, GH treatment may be considered as it could contribute to improve heart function and bone mineral density, which are frequently impaired in adult thalassaemic patients.