Health Technology Assessment and Biomedical Engineering : global trends, gaps and opportunities

The diffusion of medical devices is expanding at an astonishing rate. The increasing number of novel patents per year suggests this growth will continue. In contrast to drugs, medical devices are intrinsically dependent on the environment in which they are used and how they are maintained. This created an unprecedented global need for well-trained biomedical engineers who can help healthcare systems to assess them. The International Federation for Medical and Biological Engineering (IFMBE) is the global scientific society of biomedical engineers in official relations with the United Nations World Health Organisation (WHO) and has been very active in promoting the role of the biomedical engineer in Health Technology Assessment (HTA). The IFMBE Health Technology Assessment Division (HTAD) is the IFMBE operative branch in this field, promoting studies, projects and activities to foster the growth of this specific and very important science sector, including summer schools, training material, an HTA eLearning platform, HTA guidelines, awards and more. This article describes the vision, the mission and the strategy of the HTAD, with a focus on the results achieved and the impact this is having on global policymaking

An integrated research tool for X-ray imaging simulation

This paper presents a software simulation package of the entire X-ray projection radiography process including beam generation, absorber structure and composition, irradiation set up, radiation transport through the absorbing medium, image formation and dose calculation. Phantoms are created as composite objects from geometrical or voxelized primitives and can be subjected to simulated irradiation process. The acquired projection images represent the two-dimensional spatial distribution of the energy absorbed in the detector and are formed at any geometry, taking into account energy spectrum, beam geometry and detector response. This software tool is the evolution of a previously presented system, with new functionalities, user interface and an expanded range of applications. This has been achieved mainly by the use of combinatorial geometry for phantom design and the implementation of a Monte Carlo code for the simulation of the radiation interaction at the absorber and the detector. © 2002 Published b

Evaluation of an improved algorithm for producing realistic 3D breast software phantoms: application for mammography

PURPOSE: This work presents an improved algorithm for the generation of 3D breast software phantoms and its evaluation for mammography. METHODS: The improved methodology has evolved from a previously presented 3D noncompressed breast modeling method used for the creation of breast models of different size, shape, and composition. The breast phantom is composed of breast surface, duct system and terminal ductal lobular units, Cooper\u27s ligaments, lymphatic and blood vessel systems, pectoral muscle, skin, 3D mammographic background texture, and breast abnormalities. The key improvement is the development of a new algorithm for 3D mammographic texture generation. Simulated images of the enhanced 3D breast model without lesions were produced by simulating mammographic image acquisition and were evaluated subjectively and quantitatively. For evaluation purposes, a database with regions of interest taken from simulated and real mammograms was created. Four experienced radiologists participated in a visual subjective evaluation trial, as they judged the quality of the simulated mammograms, using the new algorithm compared to mammograms, obtained with the old modeling approach. In addition, extensive quantitative evaluation included power spectral analysis and calculation of fractal dimension, skewness, and kurtosis of simulated and real mammograms from the database. RESULTS: The results from the subjective evaluation strongly suggest that the new methodology for mammographic breast texture creates improved breast models compared to the old approach. Calculated parameters on simulated images such as beta exponent deducted from the power law spectral analysis and fractal dimension are similar to those calculated on real mammograms. The results for the kurtosis and skewness are also in good coincidence with those calculated from clinical images. Comparison with similar calculations published in the literature showed good agreement in the majority of cases. CONCLUSIONS: The improved methodology generated breast models with increased realism compared to the older model as shown in evaluations of simulated images by experienced radiologists. It is anticipated that the realism will be further improved using an advanced image simulator so that simulated images may be used in feasibility studies in mammography

Health Technology Assessment and Biomedical Engineering: Global trends, gaps and opportunities

The diffusion of medical devices is expanding at an astonishing rate. The increasing number of novel patents per year suggests this growth will continue. In contrast to drugs, medical devices are intrinsically dependent on the environment in which they are used and how they are maintained. This created an unprecedented global need for well-trained biomedical engineers who can help healthcare systems to assess them. The International Federation for Medical and Biological Engineering (IFMBE) is the global scientific society of biomedical engineers in official relations with the United Nations World Health Organisation (WHO) and has been very active in promoting the role of the biomedical engineer in Health Technology Assessment (HTA). The IFMBE Health Technology Assessment Division (HTAD) is the IFMBE operative branch in this field, promoting studies, projects and activities to foster the growth of this specific and very important science sector, including summer schools, training material, an HTA eLearning platform, HTA guidelines, awards and more. This article describes the vision, the mission and the strategy of the HTAD, with a focus on the results achieved and the impact this is having on global policymaking

An Open Source MATLAB tool for heart rate turbulence and its application to chronic heart failure assessment

In this paper we describe a software package for the development of a Heart Rate Turbulence (HRT) evaluation tool, that provides also an instrument for HRT analysis. In fact, as HRT measurement represents an indirect assessment of baroreflex, it is of great importance in all those clinical situations that benefit from baroreflex evaluation, specially in terms of risk prediction, monitoring and stratification. Based on a review of the state of the art of software related to the HRT analysis, we motivate the development of this open source software platform which could be an interesting tool both for studying HRT or for performing clinical experiments for research purposes. We present the results of the application of our package to two ECG databases from Physionet of patients suffering from Chronic Heart Failure. We performed a discriminant analysis using the HRT parameters in order to distinguish between severe CHF from mild CHF. We adopted as discriminant function the Mahalanobis distances with stratified covariance estimates. The computed HRT parameters enables severe CHF patients to be distinguished from mild CHF ones with a sensitivity and a specificity rate of 100.0% and 72.7%, respectively. As proved by the results of this research, HRT measurements appear to be an effective instrument for Congestive Heart Failure severity assessment. In particular we found that the combined use of two of the HRT parameters computed through our Matlab tool, increases the discrimination performances, especially in terms of sensitivity and accuracy. We firmly believe that the results of our study and of previously published papers about HRT encourage further investigations concerning HRT parameters in many other clinical situations and, in this scenario, the developed Matlab tool could show its potentiality for future researches