Development of sustainable models for technology evaluation in hospital.

BACKGROUND: This paper reports the development of standard techniques for technology evaluation in hospital carried out at the Florence Teaching Hospital Careggi (AOUC), where, as a complex system, the technological evaluation is a strategic and essential element for the maintenance of high-quality clinical activity and maximization of available resources. OBJECTIVE: The aim of this paper has been the development of a system of economically sustainable models for the implementation of HTA and HS analyses in the hospital environment as well as presenting, in addition to a valid scientific resilience, the methodological and temporary flexibility to satisfy needs of hospital decision-makers. METHODS: The evaluation models call for 3 main phases: an initial analysis of the in-hospital request, a collection of data, and finally a draft of a specific, easily usable set of reports. RESULTS: Three standardized and tested models of evaluation were developed, which, in relation to the objective of the request and schedule of the assignment, provide for the production of a speedy report (1-week), an intermediate report (1-month), or a extensive report typical of classical studies of hospital based HTA (1-year). It is then related to the evaluation model of the IORT (Intra-Operative Radiation Therapy) technology. DISCUSSIONS AND CONCLUSION: The developed models have permitted the construction, using personnel and laboratories within the hospital, of an evaluation system reliable and responsive to the HOSPITAL's temporary needs based on the HS and HTA analyses in the hospital environment. Regarding the applicable case of IORT, this has shown how in-hospital requests have been satisfied in the preset time: although it establishes expected improvements on the social effect and weight of the illness and reveals a high territorial strategic relevance, the introduction of IORT in the hospital presents some criticalities on the impact on the healthcare organization and the necessity of specific training of medical technologist personnel.

External quality assessment for the detection of HCV RNA, HIV RNA and HBV DNA in plasma by nucleic acid amplification technology: a novel approach.

BACKGROUND AND OBJECTIVES: In this EQA study a novel approach was used to assess the performance of blood centres and blood product manufacturers in detecting the possible contamination of plasma with HCV, HIV and HBV by NAT. MATERIALS AND METHODS: A panel of 12 samples, three negative and three positive for each virus, was distributed to the EQA participants. The positive samples were prepared, using the respective WHO standards, in order to obtain a viral concentration of about three times the 95% DL of the methods most commonly used by laboratories involved in blood screening by NAT. Participants were requested to test each sample of the panel on different days, possibly by different operators using their routine NAT assay. RESULTS: Overall, the participants' performance was satisfactory. In particular, 49 of the 59 participants (83%) were able to correctly identify all samples. Regarding the remaining 10 laboratories, in three cases a deviation from the laboratory's procedure that could be attributed to an operator's mistake was observed, in two cases a possible cross-contamination occurred while in the remaining five cases the failure to detect the positive samples couldn't be ascribed to any relevant deviation in the laboratory's procedure. CONCLUSIONS: The novel design of this EQA study allowed participants to verify their day by day activity as the study was carried out in the context of their routine testing. Under these conditions, it was demonstrated that, despite the high level of automation reached by NAT assays, human errors can still occur.

External quality assessment for the detection of blood-borne viruses in plasma by nucleic acid amplification technology: the first human immunodeficiency virus and hepatitis B virus studies (HIV EQA/1 and HBV EQA/1) and the fifth hepatitis C virus study (HCV EQA/5).

BACKGROUND AND OBJECTIVES: This External Quality Assessment (EQA) study was aimed at assessing the proficiency of blood centres and blood product manufacturers in detecting, by nucleic acid amplification technology (NAT), the possible contamination of plasma with hepatitis C virus (HCV), human immunodeficiency virus (HIV) and hepatitis B virus (HBV). MATERIALS AND METHODS: Three independent panels, one for each virus, were prepared at the Istituto Superiore di Sanità (ISS) by diluting the respective reference preparations. NAT methods used by the EQA participants included polymerase chain reaction (PCR) assays by Roche, transcription-mediated amplification (TMA) assays by Chiron and in-house PCR assays. RESULTS: Forty-three of the 45 participants (95.6%) in the HCV EQA/5 who used a validated method were consistently able to detect a nominal concentration of 100 IU/ml for all six major genotypes. In the case of the HIV EQA/1, all 35 participants detected the samples containing 1000 IU/ml HIV, while five (14.3%) did not identify the samples containing 100 IU/ml HIV. With respect to the HBV EQA/1, all 16 participants correctly identified the positive samples containing either 1000 IU/ml or 100 IU/ml HBV. No false-positive results were observed with any of the three panels. CONCLUSIONS: The HCV EQA/5 showed an improved proficiency of laboratories as compared with the HCV EQA/4. In fact, HCV genotypes 1, 2, 3 and 5 were correctly identified in 100% of the assays and genotypes 4 and 6 in 97.8% of the assays. While most of the participants in the HIV EQA/1 showed a good level of proficiency, an excellent performance was shown by all participants in the HBV EQA/1.

Airway management in an infant with congenital centrofacial dysgenesia.

The use of a laryngeal mask airway (LMA) on two occasions, in a 53-day-old and 270-day-old male infant with Tessier N.3 and N.4 facial defects, using sedation and topical anaesthesia is described. The LMA was used to manage the airway and facilitate inhalation induction of anaesthesia as the facial deformities were thought to be too extensive for the safe use of a facemask. The LMA is an alternative to a facemask and secures the airway and facilitates the inhalation induction of anaesthesia in paediatric patients with severe facial deformities.

Abdominal sacral colpopexy with Mersilene mesh.

INTRODUCTION: This study focussed on abdominal sacral colpopexy with Mersilene mesh to correct total vaginal vault prolapse. Our aim was to describe and explain our operative modifications. MATERIALS AND METHODS: From 1992 and 1999, we performed sacrocolpopexy on 25 patients for vaginal vault prolapse. We proposed a change by interposing a mesh between the vaginal vault and the sacral promontory shaped as an inverted 'V'. RESULTS: No intraoperative or postoperative complications were encountered; to date the outcome of all patients was satisfactory. CONCLUSION: Based on the results of the follow-up, this new surgical approach of abdominal sacral colpopexy can be considered as effective surgery for vaginal vault prolapse.

Ornithine decarboxylase in colonic mucosa from patients with moderate or severe Crohn's disease and ulcerative colitis.

Polyamines, as well as ornithine decarboxylase (ODC), the enzyme involved in their synthesis, were reported to be closely related to cell proliferation. In Crohn's disease and ulcerative colitis, cell destruction and proliferation increase in the active stage. The aim of the present study was to determine the ODC in both involved and uninvolved areas of the colonic mucosa of active Crohn's disease and ulcerative colitis patients. The patients were divided in two groups, owing to the different level of activity (severe or moderate), by means of clinical endoscopy, laboratory, and histology evaluations. Subjects with suspected disease, but endoscopically unconfirmed, were used as controls. In all ulcerative colitis and Crohn's disease patients the ODC values both in involved and uninvolved mucosa were significantly lower than in controls. In severe Crohn's disease ODC was significantly reduced versus moderate Crohn's disease only in affected tissues. In all ulcerative colitis patients (moderate or severe) the ODC was significantly decreased in involved mucosa compared with uninvolved mucosa. Severe ulcerative colitis showed the significantly lowest ODC. We suggest that the significant decrease of ODC in the bowel mucosa is closely related to the severity of the disease. The highest decrease of ODC in ulcerative colitis patients would be due both to the enhanced cell destruction, and to the feed-back from exogenous increased polyamine production (bowel bacteria, cell desquamation). Therefore ODC would be considered a sensitive index of the inflammatory derangement of the mucosa, especially in acute ulcerative colitis. We conclude that this behaviour may result in an enhanced risk of neoplasia.

Effect of practical layered dielectric loads on SAR patterns from dual concentric conductor microstrip antennas.

Radiation patterns of 2 and 4cm square Dual Concentric Conductor (DCC) microstrip antennas were studied theoretically with Finite Difference Time Domain (FDTD) analysis and compared with experimental measurements of power deposition (SAR) in layered lossy dielectric loads. Single and array configurations were investigated with 915 MHz excitation applied across either one, two or four sides, or four corners of the square apertures. FDTD simulations were carried out for realistic models of a muscle tissue load coupled to the DCC antennas with a 5 mm thick bolus of either distilled water or low loss Silicone Oil. This study characterizes the effect on SAR of adding three additional thin dielectric layers which are necessary for clinical use of the applicator. These layers consist of a 0.1 mm thick dielectric coating on the array surface to provide electrical isolation of DCC apertures, and 0.15 mm thick plastic layers above and below the bolus to contain the liquid. Experimental measurements of SAR in a plane 1 cm deep in muscle phantom agree well with theoretical FDTD simulations in the multi-layered tissue models. These studies reveal significant changes in SAR for applicator configurations involving low dielectric constant (Er) layers on either side of a high Er water bolus layer. Prominent changes include a broadening and centring of the SAR under each aperture as well as increased SAR penetration in muscle. No significant differences are noted between the simple and complete load configurations for the low Er Silicone Oil bolus. Both theoretical and measured data demonstrate relatively uniform SAR distributions with > 50% of maximum SAR extending to the perimeter of single and multi-aperture array configurations of DCC applicators when using a thin 5 mm water or Silicone Oil bolus.

Local and systemic effects of intraduodenal exposure to topical gallstone solvents ethyl propionate and methyl tert-butyl ether in the rabbit.

During topical dissolution of gallstones, solvent can escape to the duodenum causing toxic effects that have not yet been adequately quantified. We compared the local intestinal cytotoxic and systemic hepatotoxic effects of two gallstone solvents, methyl tert-butyl ether and ethyl propionate, on the rabbit's duodenum. Methyl tert-butyl ether, ethyl propionate, or saline (control) was infused intraduodenally for 3 hr in 32 male New Zealand rabbits. The solvents were infused either at a high infusion rate of 8.5 microl/min or at a low rate of 4.0 microl/min. Blood samples were collected for biochemical analysis from each animal before and after the 3-hr infusion period. A standardized histologic scoring system was used by a pathologist blinded to the treatments to quantify liver and intestinal tissue injury. None of the animals studied showed any significant changes in serum alkaline phosphatase, amylase, bilirubin, or their hepatic histology or histologic scoring for mucosal necrosis and ulceration. At the higher dose, methyl tert-butyl ether produced significantly more submucosal inflammation (P = 0.0017) and showed a trend of causing more submucosal edema than ethyl propionate, but ethyl propionate led to significantly higher elevations of aminotransferases than methyl tert-butyl ether as compared to saline. There were no detectable blood levels of methanol or ethanol in any of the animals studied. Ethyl propionate may be less damaging to the intestinal mucosa of the rabbit than methyl tert-butyl ether, but at the higher dose (equivalent to 60 ml/3 hr in a 70-kg human) it appears to produce more biochemical liver injury when administered intraduodenally.

Effect of ursodeoxycholic acid on hypertransaminasaemia and bile acid composition in patients undergoing bone marrow transplantation--a double-blind randomized control study.

A double-blind randomized placebo controlled trial of ursodeoxycholic acid was performed in 31 patients undergoing T-cell depleted allogeneic or autologous bone marrow transplantation to determine the effectiveness of this hydrophilic bile acid in improving the increase in serum liver enzymes that generally accompanies this procedure. Neither group showed any significant difference in magnitude of the increases in serum transaminases and gamma-glutamyltranspeptidase following the conditioning regimen that included chemotherapy and total body irradiation. In the 6 months after transplantation, serum enzymes decreased in both groups, but were consistently higher in the placebo treated patients, indicating that ursodeoxycholic enhances normalization of liver. Faecal bile acid showed that following chemotherapy and irradiation in which intestinal bacteria are ablated, secondary bile acid formation was practically abolished and faeces contained mainly cholic and chenodeoxycholic acids. During bile acid treatment, ursodeoxycholic acid accounted for 31.3 +/- 10.9% of faecal bile acids compared with 4.0 +/- 2.1% in the basal period. Serum and urinary ursodeoxycholic acid concentrations (mean +/- SD, 13.3 +/- 6.9 mumol/L and 2.65 +/- 0.84 mumol/L, respectively) were significantly higher in patients receiving bile acid than in thos on placebo (mean +/- SD, 0.15 +/- 0.12 mumol/L and 0.29 +/- 0.35 mumol/L, respectively) thus confirming compliance.

FDTD electromagnetic and thermal analysis of interstitial hyperthermic applicators. Finite-difference time-domain.

In this paper, the electromagnetic and thermal behavior of interstitial applicators was analyzed by using the Finite-Difference Time-Domain method. Two configurations were considered: a simple insulated dipole antenna radiating in a layered tissue, and an air cooled applicator radiating in a tissue-equivalent phantom. The proposed approach allows a detailed modeling of the complete structure of the applicator. Furthermore, Specific Absorption Rate and temperature distributions can be determined considering real clinical or experimental conditions. The temperature distribution for the air cooled applicator has been compared with experimental results.

[Assessment of the effects of alfuzosin on miction with dynamic echography]. / Valutazione degli effetti dell'alfuzosina sulla minzione mediante ecografia dinamica.

Alfuzosina has a specific antagonist effect on the alfa-1-adrenergic post-junctional receptor posed at urethral laeve musculature, prostatic capsule and vesical trgonum. It's and ideal drug the symptoms of the difficult urinary flow typical of the benign prostatic hypertrophia (IPB) and of some patologies of vesical collum to attenuate. With this work we want to demonstrate the anatomic alterations of vesical collum and prostatic urethra by means of dynamic recording mictional phase with transrectal scan carried out before and after treatment. In this study, 30 patients were divided into three groups of 10 in relation to the pathology: overtone of vesical collum, little benign prostatic ipertrophia and great benign prostatic ipertrophia have included. The patients of each group have also been divided in undergroups of five (selected with the method of double-blind) of which the first treated with alfuzosina 7.5 mg/die for 30 days and the second with placebo. Considering the limits of this study, the analysis of the results have permitted to conclude that the drug has determined a subjective improvement in all patients except those with great IPB, while the objective valuation, reached comparing scan dynamic pictures before and after treatment, has made it possible to visualize an improvement on the opening of the vesical collum and the prostatic urethra after therapy with great variations of the size of che mictional funnel and same prostatic urethra. The alfuzosina is efficacious, in the cases under examination, except the third group were the compression on the urethra was of an elevated degree.

A dipole-type intracavitary hyperthermic applicator with a metallic reflector: experiments and theoretical analysis.

A water-cooled electromagnetic (EM) dipole, for intracavitary hyperthermia, embodying a metallic reflector to give directional characteristics to the SAR and then to the heating pattern in the biological tissue, is considered. The influence of the reflector on the SAR deposition has been theoretically modelled with an EM analysis which uses the method of moments (MOM). A thermal model, based on the heat transfer equation, is used to predict temperature distribution, which exhibits a directivity related to the angular extension of the reflector. Experiments have been carried out in a polyacrylamide phantom. The temperature distribution detected with a liquid crystal sheet shows fairly good agreement with theoretical predictions.

Detection of anti-HCV antibodies in immunoglobulin preparations by recombinant immunoblot assay.

The presence of anti-HCV antibodies in immunoglobulin preparations was investigated by recombinant immunoblot assay (RIBA) and enzyme immunoassay (EIA). While EIA was found to be suitable for detecting anti-HCV antibodies in immunoglobulin preparations, the RIBA could not be used without modifying the standard procedure developed for use with human sera. The two modifications were: (1) incubation with the anti-human IgG conjugate in a single test tube for each strip, instead of in a common vessel; (2) removal of the conjugate after 15 min and its replacement with fresh conjugate for a second 15 min incubation period. Thirty-six immunoglobulin preparations were tested using this modified procedure. Twenty-nine out of 31 (93.5%) preparations received in 1992 were anti-HCV positive, whereas the five immunoglobulin preparations received in 1993 were negative. These results were compared with those obtained on the same samples with the EIA. The percentage of samples positive with EIA was 74.2%. The difference between the results obtained with modified RIBA and EIA was statistically significant (P < 0.05).

[Chronic therapy with ursodeoxycholic acid in a child with Alagille syndrome]. / Terapia cronica con acido ursodesossicolico in un bambino affetto da Sindrome di Alagille.

The effectiveness of oral bile acid therapy with ursodeoxycholic acid (10 mg/kg/day) was investigated in a 10 year old boy affected by Alagille's Syndrome, a chronic cholestatic disorder due to congenital hypoplasia of the intrahepatic biliary ducts. Cholestatic and hepatonecrotic indices were measured before and during ursodeoxycholic acid therapy and 1 month after stopping and 36 months after restarting the treatment. Ursodeoxycholic acid led to a marked improvement in the cholestatic and hepatonecrotic parameters which was maintained during all the treatment phase. Pruritus and steatorrhea disappeared during the treatment with ursodeoxycholic acid. Histological examination of the liver biopsy after the treatment revealed a disappearance of the biliary plugs but without increasing he intrahepatic bile ducts. The results suggest that ursodeoxycholic acid may improve the condition of the children affected by Alagille's Syndrome, specially when the liver transplantation is required, and indicate a need for long term studies in a larger number of patients.

[Bilateral carcinoma of the breast: treatment and prevention, Review of the literature]. / Il carcinoma bilaterale della mammella: trattamento e profilassi. Revisione della letteratura.

Authors analyze 256 patients admitted in III Clinica Chirurgica of University of Rome "La Sapienza" for breast cancer, from 1982 to 1992; 16 of them had later developed another neoplasm in the opposite breast. After a retrospective study of the clinical history of all patients they came to the conclusion that bilateral neoplasm frequency is similar to that reported in world literature (1-18%) (23, 9, 2). Moreover, are analyzed the primary risk factors for a bilateral carcinoma, and they consider the utility of the prophylactic surgical treatment of the opposite breast.