Innovative and conventional "conservative" technologies for the treatment of uterine fibroids in Italy: a multidimensional assessment.

BACKGROUND: To evaluate the potential benefits of the Magnetic Resonance-guided high intensity Focused Ultrasound (MRgFUS) introduction in the clinical practice, for the treatment of uterine fibroids, in comparison with the standard "conservative" procedures, devoted to women who wish to preserve their uterus or enhance fertility: myomectomy and uterine artery embolization (UAE). METHODS: A Health Technology Assessment was conducted, assuming the payer's perspective (Italian National Healthcare Service). The nine EUnetHTA Core Model dimensions were deeply investigated, by means of i) a literature review; ii) the implementation of health economics tools (useful for uterine fibroids patients' clinical pathway economic evaluation, and budget impact analysis), to define MRgFUS economic and organizational sustainability, and iii) administration of specific questionnaires filled by uterine fibroids' experts, to gather their perceptions on the three possible conservative approaches (MRgFUS, UAE and myomectomy). RESULTS: Literature revealed that MRgFUS would generate several benefits, from a safety and an efficacy profile, with significant improvement in symptoms relief. Advantages emerged concerning the patients' perspective, thus leading to a decrease both in the length of hospital stay (p-value< 0.001), and in patients' productivity loss (p-value = 0.024). From an economic point of view, the Italian NHS would present an economic saving of - 6.42%. A positive organizational and equity impact emerged regarding the capability to treat a larger number of women, thus performing, on average, 131.852 additional DRGs. CONCLUSIONS: Results suggest that MRgFUS could be considered an advantageous technological alternative to adopt within the target population affected by uterine fibroids, demonstrating its economic and organisational feasibility and sustainability, with consequent social benefits.

A Health Technology Assessment: laparoscopy versus colpoceliotomy.

INTRODUCTION: The objective of this paper is the comparison between two different technologies used for the removal of a uterine myoma, a frequent benign tumor: the standard technology currently used, laparoscopy, and an innovative one, colpoceliotomy. It was considered relevant to evaluate the real and the potential effects of the two technologies implementation and, in addition, the consequences that the introduction or exclusion of the innovative technology would have for both the National Health System (NHS) and the entire community. METHODS: The comparison between these two different technologies, the standard and the innovative one, was conducted using a Health Technology Assessment (HTA). In particular, in order to analyse their differences, a multi-dimensional approach was considered: effectiveness, costs and budget impact analysis data were collected, applying different instruments, such as the Activity Based Costing methodology (ABC), the Cost-Effectiveness Analysis (CEA) and the Budget Impact Analysis (BIA). Organisational, equity and social impact were also evaluated. RESULTS: The results showed that the introduction of colpoceliotomy would provide significant economic savings to the Regional and National Health Service; in particular, a saving of € 453.27 for each surgical procedure. DISCUSSION: The introduction of the innovative technology, colpoceliotomy, could be considered a valuable tool; one offering many advantages related to less invasiveness and a shorter surgical procedure than the standard technology currently used (laparoscopy).

Analysis of errors in histology by root cause analysis: a pilot study.

INTRODUCTION: The study objective is to evaluate critical points in the process of pre-analytical histology in an Anatomic Pathology laboratory. Errors are an integral part of human systems, including the complex system of Anatomic Pathology. Previous studies focused on errors committed in diagnosis and did not consider the issues related to the histology preparation of routine processes. METHODS: Root Cause Analysis was applied to the process of histology preparation in order to identify the root cause of each previously identified problem. The analysis started by defining an 'a priori' list of errors that could occur in the histology preparation processes. During a three-month period, a trained technician tracked the errors encountered during the process and reported them on a form. 'Fishbone' diagram and 'Five whys' methods were then applied RESULTS: 8,346 histological cases were reviewed, for which 19,774 samples were made and from which 29,956 histologies were prepared. 132 errors were identified. Errors were detected in each phase: accessioning (6.5%), gross dissecting (28%), processing (1.5%), embedding (4.5%), tissue cutting and slide mounting (23%), coloring, (1.5%), labeling and releasing (35%). DISCUSSION: Root cause analysis is effective and easy to use in clinical risk management. It is an important step for the identification and prevention of errors, that are frequently due to multiple causes. Developing operators' awareness of their central role in the risk management process is possible by targeted training. Furthermore, by highlighting the most relevant points of interest, it is possible to improve both the methodology and the procedural safety.

Pressure ulcers management: an economic evaluation.

INTRODUCTION: Pressure ulcer management represents a growing problem for medical and social health care systems all over the world, particularly in European Union countries where the incidence of pressure ulcers in older persons (> 60 years of age) is predicted to rise. OBJECTIVES: The aim of this study was to provide evidence for the lower impact on economic resources of using advanced dressings for the treatment of pressure ulcers with respect to conventional simple dressings. METHODS: Two different models of analysis, derived from Activity Based Costing and Health Technology Assessment, were used to measure, over a 30-day period, the direct costs incurred by pressure ulcer treatment for community-residing patients receiving integrated home care. RESULTS: Although the mean cost per home care visit was higher in the advanced dressings patient group than in the simple dressings patient one (E 22.31 versus E 16.03), analysis of the data revealed that the cost of using advanced dressings was lower due to fewer home care visits (22 versus 11). CONCLUSION: The results underline the fact that decision-makers need to improve their understanding of the advantages of taking a long-term view with regards to the purchase and use of materials. This could produce considerable savings of resources in addition to improving treatment efficacy for the benefit of patients and the health care system.

Investigating the estrogenic risk along the river Po and its intermediate section.

Different endpoints have been used to investigate the occurrence of estrogenic risk along the Po River, particularly its middle section. An in vitro assay based on recombinant yeast could not detect estrogenic activity in bed sediments of the Italian river or in bile samples of five Cyprinid species, with the only exception being one carp (Cyprinus carpio) captured downstream of the River Lambro, a polluted tributary of the middle River Po. Chemical analyses of fish bile and water samples from the same middle section showed diffuse contamination by moderately low levels of estrogenic chemicals (estrone [E1], 17beta-estradiol, estriol [E3], 17alpha-ethinylestradiol, 4-nonylphenol [NP], 4-tert-octylphenol [tOP], 4-n-octylphenol, and bisphenol A) but they were of limited help in understanding the risk present in the downstream area where intersex barbel were previously found. In contrast, the analyses of River Lambro waters showed that this tributary is a source to the middle River Po of all eight estrogens investigated. Analyses of bed sediments and macroinvertebrates from the same area consistently showed at least two levels of contamination, with the downstream stretch showing higher concentrations of natural steroids (E1 and E3) and xenoestrogens (NP and tOP). Accordingly, new histologic examinations undertaken on young barbel (Barbus sp.) showed intersex gonads only in the individuals captured in the downstream stretch, thereby confirming previous results. Present findings confirm the occurrence of disrupting conditions in the middle River Po and provide the first suggestions of cause-effect relationships.

GC-MS analysis of dichlobenil and its metabolites in groundwater.

We have developed a new method for the determination of the widely used herbicide 2,6-dichlorobenzonitrile (dichlobenil) and its major metabolites 2,6-dichlorobenzamide (BAM) and 2,6-dichlorobenzoic acid (2,6-DCBA) in groundwater samples. The procedure is based on solid phase extraction (SPE) combined with a derivatization procedure before GC-MS analysis in order to quantify analytes simultaneously. This method can be used from regulatory laboratories for monitoring the presence of dichlobenil and its metabolites during testing groundwater samples quality.

Organic tracers identification as a convenient strategy in industrial landfills monitoring.

Today, a significant environmental problem is due to the presence of industrial landfills, some of them old, which can release toxic compounds into the environment (Chemosphere 42 (2001) 415; Chemosphere 31 (1995) 3455). The identification of directly linked to the leachate tracers of contamination in the wells around the landfills, as early markers of a potential risk for the environment and/or man, is a good strategy for an early evaluation of contamination. Our protocol developed for wells water characterization is based on solid phase extraction combined with GC-MS and HPLC-MS/MS. In this way a list of organic contaminants of a specific industrial landfill is obtained, giving a solid basis also for the risk assessment. Here we present some specific examples and the use of these pollutants for environmental monitoring.