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Introduction: Achieving haemostasis is critical in surgical procedures. Surgical bleeding is associated with an increased risk of mortality and morbidity with consequences at both clinical and organizational level, and with significant economic implications. In addition to conventional methods for controlling intraoperative bleeding, many topical adjunctive hemostatic products are available; among them Floseal® (Baxter Healthcare Corporation), a gelatin-based hemostatic matrix. The aim of this study is to provide an updated systematic literature review of Floseal® in cardiac surgery and estimate its associated economic impact in an Italian hospital. Methods: A literature search was conducted in MEDLINE and the Cochrane Library over the period 2013-2016 to identify new publications related to Floseal® in cardiac surgery, in addition to those already included in the systematic review of Echave et al. Furthermore, we investigated the economic impact of the use of Floseal® adapting the model elaborated by Tackett et al. to the Italian NHS. Four new studies were selected. Results: High variability in surgical procedures, choice of hemostatic products compared to Floseal® and outcome definition is confirmed. Clinical, organizational, and economics endpoints were investigated. A cost-consequence analysis estimated relevant savings. A scenario analysis, despite showing a high variability in patient level savings (€ 441-2.831), confirmed economic advantages associated with Floseal®. Discussion: Results support prior research both in terms of heterogeneity of evidence on the effectiveness of Floseal® in cardiac surgery and cost implications. The use of Floseal® achieves substantial cost savings in a hypothetical Italian hospital with a cardiac surgery unit.

Background. Despite improvements in blood donor selection and screening procedures, transfusion recipients can still develop complications related to infections by known and emerging pathogens. Pathogen reduction technologies (PRT) have been developed to reduce such risks. The present study, developed whithin a wider health technology assessment (HTA) process, was undertaken to estimate the costs of the continuing increase in the use of platelet PRT in Italy. Materials and methods. A multidisciplinary team was established to perform the HTA and conduct a budget impact analysis. Quantitative data on platelet use were derived from the 2015 national blood transfusion report and from the Italian Platelets Transfusion Assessment Study (IPTAS). The current national fee of 60 Euro per platelet PRT procedure was used to quantify the costs to the Italian National Health Service (INHS). The analysis adopts a 3-year time-frame. In order to identify the impact on budget we compared a scenario representing an increased use of PRT platelets over time with a control scenario in which standard platelets are used. Results. Progressive implementation of PRT for 20%, 40% and 66% of annual adult platelet doses could generate an increase in annual costs for the INHS amounting to approximately 7, 14 and 23 million Euros, respectively. Use of kits and devices suitable for the treatment of multiple adult platelet doses in one PRT procedure could lower costs. Discussion. In order to fully evaluate the societal perspective of implementing platelet PRT, the increase in costs must be balanced against the expected benefits (prevention of transfusion-transmissible infections, white cell inactivation, extension of platelet storage, discontinuation of pathogen detection testing). Further studies based on actual numbers of platelet transfusion complications and their societal cost at a local level are needed to see the full cost to benefit ratio of platelet PRT implementation in Italy, and to promo

Study question: What is the risk for complications after uterine leiomyoma embolisation and what are the factors associated with complications? Summary answer: The cumulative risk of complications after embolisation is relatively low even in the long term, but submucosal leiomyoma location may increase the risk. What is known already: A broad spectrum of complications after leiomyoma embolisation have been described with widely varying rates. There is uncertainty over the actual risk of complications and the factors associated with this risk. Study design, size, duration: This was a prospective cohort study of 288 consecutive women undergoing leiomyoma embolisation set in the general gynaecology clinic of a university teaching hospital between January 2001 and December 2010. Participants/materials, setting, methods: Complications occurring after embolisation were categorized as major or minor according to the severity of their impact on health, the level of care required and the outcome. Cumulative complication rates were estimated by survival analysis and log-rank tests according to baseline variables. Multivariable Cox proportional hazards analysis was performed to adjust for confounders. Main results and the role of chance: Forty-eight patients experienced a complication at a median of 5 months (95% CI,4.1-11.4) after embolisation. Complications were minor in 38 and major in 10 patients. The cumulative overall complication rate was 13% (95% CI,9.0-17.0) at 6 months, 16% (95% CI,11.0-20.0) at 1 year, 17% (95% CI,12.0-22.0) at 3 years, 18% (95% CI,12.9-22.8) at 5 years. The most frequent complication (19/48, 39.6 %) was leiomyoma expulsion, which occurred spontaneously in 13 (68.4%) cases and required assistance in 6 (31.6%) cases. Eight (2.8%) patients underwent re-intervention, including 6 hysteroscopic myomectomies, 1 laparoscopic myomectomy, and 1 hysteroscopic adhesiolysis, as a result of a complication. Submucosal leiomyoma location was the only baseline vari

It is known that ethical, legal, social and organizational domains are formally included among others in an health technology assessment (HTA)process. Nevertheless, there is - for various reasons - some difficulty to include those domains from the substantial point of view. The result is non infrequently that the HTA report will substantially reduces to the "classic" domanins represented by efficacy, safety, epidemiologic, economic domains, leaving out the other domains. This papaer aims to propose and argue in favour of the possibile introduction of the ELSI lofics in the HTA processes

BACKGROUNDUnilocular-solid ovarian cysts are a rare but challenging pathology in young women, with a desire to spare their fertility. In these cases, the risks of borderline and invasive disease are around 10 and 20%, respectively. No ultrasound rule has yet demonstrated the ability to discriminate with high accuracy, a borderline tumor from a benign tumor or 'invasive tumor'. The aim of this study was to assess the predictive performance of different ultrasound parameters in differentiating benign and borderline tumors versus invasive malignant tumors in premenopausal patients with unilocular-solid ovarian masses.METHODSWomen aged ≤50 years with unilocular-solid adnexal masses with a maximum diameter ≤10 cm, undergoing surgery in our department within 3 months from ultrasound examination, were included in this retrospective study. A standardized ultrasound examination technique and predefined definitions of ultrasound characteristics were used. The results of ultrasound examination using gray scale and color Doppler were compared with the histological examination of the respective surgical specimens.RESULTSThe study included 51 patients. On histological examination, 36 (70%) lesions were classified as benign, 10 (20%) as borderline ovarian tumors and 5 (10%) as invasively malignant tumors. In receiver-operating characteristic curve analysis, the best cut-off for the largest solid component with regard to discriminating non-invasive (benign or borderline) from invasive tumors was 14 mm. A largest solid component >14 mm, the presence of papillation blood flow and the combination of the two parameters provided a sensitivity of 100% and a specificity of 63, 63 and 80%, respectively.CONCLUSIONSTransvaginal ultrasound examination seems to be able to discriminate between invasive and non-invasive tumors in the premenopausal patients with unilocular-solid adnexal masses. Because of the retrospective nature of the study, further prospective clinical trials are needed to

OBJECTIVES: To prospectively assess the diagnostic performance of transvaginal ultrasound and magnetic resonance imaging (MRI), using histology as the gold standard, with regard to the presence, size, and extent of invasive cervical cancers and the detection of metastatic lymph nodes. METHODS: This was a prospective study designed to examine patients with invasive cervical cancer by means of ultrasonography and MRI within 1 week before surgery. We included patients with early cervical cancer planned for primary surgery and patients with locally advanced cervical cancer planned for surgery after neoadjuvant treatment. RESULTS: An invasive cervical cancer tumor was confirmed in the 33 patients triaged for primary surgery. A residual tumor mass was documented in 27 out of 35 patients (77%) who underwent surgery after neoadjuvant treatment, with no residual tumor in eight (23%) cases. Transvaginal ultrasound and MRI examinations showed the presence of the tumor mass in 56/60 (93%) and in 53/60 (88%) cases, respectively. Ultrasound and MRI detected the depth of stromal invasion to be greater than two-thirds with a sensitivity of 100% (16/16) and 94% (15/16) (P = 1) and a false-positive rate of 25% (13/52) and 15% (8/52) (P = 0.58), respectively. Both ultrasound and MRI provided low sensitivities (3/5, 60% and 2/5, 40% respectively, P = 1) and the same false-positive rate (7/63, 11%) for the presence of parametrial infiltration. One of the 11 patients with metastatic lymph nodes was detected at ultrasound examination (sensitivity 9%) with no false-positive cases, while MRI correctly identified three positive cases (sensitivity 27%, 3/11) with two false-positive cases (false positive rate 4%, 2/55). CONCLUSIONS: Ultrasound and MRI had similar sensitivity and specificity with regard to the parameters investigated. Ultrasound has the advantages over MRI of low cost, widespread availability and of being a relatively quick procedure. Ultrasound should be considered as a suitab

In a context of continuous spread health technologies, in which particular intensive procedures are performed, the use of procedure volume indicators supports the decision making process in monitoring and improving the healthcare quality. The aim of our work focuses on the evaluation of the association between the volume of procedures performed by organizational units inside an Italian University Hospital and the results in terms of mortality and prolonged length of stay (LOS). Volume indicators concerning esophageal resection, pancreatic resection, abdominal aortic aneurysm repair, coronary artery bypass graft and percutaneous transluminal coronary angioplasty were analysed according to the Agency of Health Care Research and Quality's criteria. A retrospective observational study was conducted analysing hospital discharged databases and operating room records for the period 2000-2005. Descriptive and inferential statistical analysis were performed using SPSS software 13.0 version. Regarding prolonged LOS, a statistical significant difference emerged among high and low volume organizational units for pancreatic resections, bypass, and angioplasty with respectively adjusted OR at 2.4 (C.I. 95% 1.04-5.53); 1.67 (C.I. 95% 1.29-2.16) and 3.34 (CI 95% 2.60-4.28). For mortality, a statistical significant difference emerged for abdominal aortic aneurysm repair and bypass with respectively OR at 21.02 (C.I. 95% 2.22-199.64) and 26.55 (C.I. 95% 15.30 - 46.07). The use of procedure volume indicators could help hospital administrators and medical professionals balance competing values such as control of cost and continuous quality improvement.