Modeling the Cost-Effectiveness for Cement-Less and Hybrid Prosthesis in Total Hip Replacement in Emilia Romagna, Italy

Background. The aim of the present study was to assess the cost-effectiveness of cement-less versus hybrid prostheses in total hip replacement (THR) in patients diagnosed with primary osteoarthritis. Methods. Effectiveness data were obtained from the Emilia-Romagna Regional Registry on Orthopaedic Prosthesis (RIPO), which collects information on all orthopaedic intervention performed in Emilia-Romagna (41,199 total hip replacements performed from 2000 to 2007), and from which we obtained survival curves and transition probabilities for the cement-less and hybrid prostheses, respectively. Conversely, costs were derived from regional databases through a specific procedure, which allowed us to register individual component's costs for both primary and subsequent revision interventions. A specific Markov transition model was constructed in order to consider the 3 types of revisions that an implant could possibly undergo through its life-span: total, cup or stem, head insert or neck. The cost-effectiveness was expressed in terms of cost per "revision-free" life year. Results and conclusions. Considering a 70-y old patient undergoing THR, the cementless strategy resulted more effective but more costly than the hybrid solution, with an incremental cost effectiveness ratio of 2401.63 (sic) per revision-free life year. Following a deterministic sensitivity analysis, hybrid and cementless fixation showed, respectively, a dominance profile for patients older than 83 y and younger than 43 y, whereas for all ages in between, we report a progressive increase in the ICER of cementless prostheses. Our results proved to be robust, as underlined by the probabilistic sensitivity analysis performed using cost distributions. (C) 2011 Elsevier Inc. All rights reserved

A method for addressing research gaps in HTA, developed whilst evaluating robotic-assisted surgery: a proposal

Abstract Background When evaluating health technologies with insufficient scientific evidence, only innovative potentials can be assessed. A Regional policy initiative linking the governance of health innovations to the development of clinical research has been launched by the Region of Emilia Romagna Healthcare Authority. This program, aimed at enhancing the research capacity of health organizations, encourages the development of adoption plans that combine use in clinical practice along with experimental use producing better knowledge. Following the launch of this program we developed and propose a method that, by evaluating and ranking scientific uncertainty, identifies the moment (during the stages of the technology's development) where it would be sensible to invest in research resources and capacity to further its evaluation. The method was developed and tested during a research project evaluating robotic surgery. Methods A multidisciplinary panel carried out a 5-step evaluation process: 1) definition of the technology's evidence profile and of all relevant clinical outcomes; 2) systematic review of scientific literature and outline of the uncertainty profile differentiating research results into steady, plausible, uncertain and unknown results; 3) definition of the acceptable level of uncertainty for investing research resources; 4) analysis of local context; 5) identification of clinical indications with promising clinical return. Results Outputs for each step of the evaluation process are: 1) evidence profile of the technology and systematic review; 2) uncertainty profile for each clinical indication; 3) exclusion of clinical indications not fulfilling the criteria of maximum acceptable risk; 4) mapping of local context; 5) recommendations for research. Outputs of the evaluation process for robotic surgery are described in the paper. Conclusions This method attempts to rank levels of uncertainty in order to distinguish promising from hazardous clinical use and to outline a research course of action. Decision makers wishing to tie coverage policies to the development of scientific evidence could find this method a useful aid to the governance of innovations.</p

Preliminary investigation by LC-MS/MS of perfluorinated compounds presence in basses reared and fished in Italy

The term perfluorinated (PFCs) defines synthetic fully-fluorinated compounds; since the ‘50s they have been largely employed in a wide range of industrial and consumer applications, due to their chemical and physical properties. Only recently researches on their potential adverse effects on both the environment and human health have been conducted, highlighting carcinogenic activity, toxic effects on reproduction, liver and kidney. Human exposure to PFCs is mainly through diet, and in particular fishery products are one of the most contaminated food. Perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) are the two most important and investigated compounds of this group. The aim of this work was to carry out a preliminary monitoring on the presence of these two molecules in 50 bass muscle samples, of which 30 reared and 20 fished, collected from different Italian areas of the Mediterranean Sea. The method used was based on an extraction with organic solvent followed by two purification steps: one with salts and one with dispersive solid phase. The extract was finally analysed by means of a UPLC-MS/MS system. Data showed a relevant contamination of this species and evidenced a significant difference of concentrations between fished (PFOS from 112.4 ng/L to >2000 ng/L and PFOA from 3.3 ng/L to 487.0 ng/L) and reared basses (PFOS from 11.1 ng/L to 104.5 ng/L and PFOA from <3 ng/L to 51.4 ng/L). Even if these levels of contamination are sensibly lower than those observed in several studies, fished basses could represent a more relevant source of PFCs exposure in human diet