Success Factors for Scaling Up the Adoption of Digital Therapeutics Towards the Realization of P5 Medicine.

Introduction: Digital therapeutics (DTx) can be a valuable contribution to the successful scale up of P5 Medicine (personalized, participatory, predictive, preventive, precision medicine) as they offer powerful means of delivering personalization and active patient participation in disease self-management. We investigated how the approval and adoption of DTx within health systems have been approached in five selected European countries and regions, with a view to proposing success factors scaling up their adoption.

Methodology: Preliminary research established best countries or region candidates as being Germany, UK, France, Belgium, and the Spanish Region of Catalonia.

ICT for quality and safety of care: beyond interoperability.

Risk Management in healthcare is a particularly challenging task. From a health system perspective a systemic and person centered approach is needed. From an ICT perspective, continuity of care and sharing information for clinical purposes, research and care improvement can be supported though interoperable systems and services and concurrent ability of proper interpretation of this knowledge by different users.

Evaluation of digital breast tomosynthesis reconstruction algorithms using synchrotron radiation in standard geometry.

Purpose: In this article, the image quality of reconstructed volumes by four algorithms for digital tomosynthesis, applied in the case of breast, is investigated using synchrotron radiation.

Methods: An angular data set of 21 images of a complex phantom with heterogeneous tissue-mimicking background was obtained using the SYRMEP beamline at ELETTRA Synchrotron Light Laboratory, Trieste, Italy. The irradiated part was reconstructed using the multiple projection algorithm (MPA) and the filtered backprojection with ramp followed by hamming windows (FBR-RH) and filtered backprojection with ramp (FBP-R).

Experimental validation of a radiographic simulation code using breast phantom for X-ray imaging.

Computer models and simulations of X-ray imaging systems are becoming a very precious tool during the development and evaluation of new X-ray imaging techniques. To provide, however, a faithful simulation of a system, all components must be accurately modelled and tested, followed by verification through experimental measurements. This paper presents a validation study of the XRayImagingSimulator, an in-house developed X-ray imaging simulator, which is extensively used as a basic tool in carrying out complex breast imaging simulations.

Simulation studies on the effect of absorbers on dose distribution in rotational radiotherapy.

The effect of cylindrical protector dimensions, material and distance from the source on the dose distribution in rotational radiotherapy was studied to assess the potential protection possibilities of small-sized radiosensitive structures, such as spinal cord. The dose distributions were evaluated in terms of dose at the protected region and surface dose, ratio of the dose at the protected region to the maximum dose, and dose gradient. High-density materials, such as lead, tungsten, gold and cerrobend, along with new polymer-metal composite ones were used in simulation studies, performed by an in-house developed Monte Carlo Radiotherapy Simulator.

eHealth in Greece: strategic and implentation perpectives.

The main elements of the Greek Strategy for eHealth are presented, against a background overview of recent, relevant policy development. These elements, together with the current state of implementation were captured by the eHealth ERA survey on progress in individual Member States. An assessment of findings against targets set by the EU eHealth Action Plan and a reflection on the key success factors for converting policy into results are also presented.

Dual-energy mammography: simulation studies.

This paper presents a mammography simulator and demonstrates its applicability in feasibility studies in dual-energy (DE) subtraction mammography. This mammography simulator is an evolution of a previously presented x-ray imaging simulation system, which has been extended with new functionalities that are specific for DE simulations. The new features include incident exposure and dose calculations, the implementation of a DE subtraction algorithm as well as amendments to the detector and source modelling.

Estimation of the heart respiratory motion with applications for cone beam computed tomography imaging: a simulation study.

Computed tomography (CT) reconstruction methods assume imaging of static objects; object movement during projection data acquisition causes tomogram artifacts. The continuously moving heart, therefore, represents a complicated imaging case. The associated problems due to the heart beating can be overcome either by using very short projection acquisition times, during which the heart may be considered static, or by ECG-gated acquisition.

A three-dimensional breast software phantom for mammography simulation.

This paper presents a methodology for three-dimensional (3D) computer modelling of the breast, using a combination of 3D geometrical primitives and voxel matrices that can be further subjected to simulated x-ray imaging, to produce synthetic mammograms. The breast phantom is a composite model of the breast and includes the breast surface, the duct system and terminal ductal lobular units. Cooper's ligaments, the pectoral muscle, the 3D mammographic background and breast abnormalities.

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.

Image quality in extended arc filtered digital tomosynthesis.

Purpose: To study image quality in filtered digital tomosynthesis (FDTS) tomograms as a function of their reconstruction arc, using isocentrically acquired, fluoroscopic projection data.

Material And Methods: Both digital tomosynthesis (DTS) and cone beam CT (CBCT) reconstruction algorithms are based on backprojection and use cone beam projection data as input. Under limited angle conditions, CBCT is reduced to FDTS, where only a subset of projection data are used for reconstruction.

Q-Pro: a quality control management system for medical equipment.

Q-Pro is an application for quality control (QC) and inspection of medical equipment. The system has been designed on the basis of a broad requirements analysis, contributed by clinical engineers from several European countries and with a focus on current and forthcoming regulatory requirements concerning the quality control and risk management for medical equipment. Q-Pro comprises a generalized application, providing the necessary flexibility to accommodate the different degrees of difficulty and specialization in creating or customizing QC protocols, carrying out inspections and managing collected data.

Education in biomedical engineering: experience from a European ERASMUS program.

Based on recent advances in biomedical research and the developments of new equipment and techniques, the field of Biomedical Engineering and Health Care Telematics are currently undergoing a rapid evolution characterized by an increasing degree of specialization. This, in turns, imposes new requirements in advanced education, while the changing scene at European level, introduces a major challenge for harmonization and standardization of education with a focus on meeting the emerging needs. At the same time information technologies provide new means and tools supporting the educational and training activities.

Improving user acceptance of health-care telematics.

Telehealth represents a new approach to health-care with the potential for improving accessibility and reducing costs. Over the years, technology has become increasingly interactive, cheaper and standardized. Despite this, the uptake of technology has been low.

A software data generator for radiographic imaging investigations.

A software data generation tool, intended to be used in radiographic applications, has been developed. The application integrates a phantom design module and an imaging simulator. Phantoms can be described as a set of either geometrical objects or voxels, or contours drawn on multiple tomographic slices.

A protocol building software tool for medical device quality control tests.

Q-Pro is an application for Quality Control and Inspection of Medical Devices. General system requirements include friendly and comprehensive graphical environment and proper, quick, easy and intuitive user interface. Functions such as, a tool library for protocol design widely used multimedia, as well as, a support of a local database for protocol and inventory data archiving are provided by the system.

Monte Carlo simulation of the radiographic imaging procedure for electronically designed phantoms.

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 and image formation. This software tool is an augmented version of a previously presented system with expanded range of application by the implementation of Monte Carlo approach for the simulation of the radiation interaction at the absorber and the detector. Phantoms are created as composite objects from geometrical or voxelized primitives and can be subjected to simulated irradiation process.

Three-dimensional localisation based on projectional and tomographic image correlation: an application for digital tomosynthesis.

Accurate three-dimensional tumor localisation in Radiotherapy, is critical to the treatment outcome, particularly when high dose gradients are present. A number of techniques have been proposed for the localisation of anatomical structures or markers. The present study proposes an approach to a concurrent maximisation of localisation accuracy and efficiency by correlation of tomographic and projectional images.

An integrated system for the production of field shaping devices in radiotherapy.

A system has been developed in our department that simplifies the production processes of field shaping devices in radiotherapy, integrating an image grabbing and processing facility at a radiotherapy simulator and an automated block cutter. The data acquisition subsystem captures images, processes and corrects them for pincushion distortions, creates a composite radiograph, records user defined contours of blocks and exports data to the block cutter controller. A robotic subsystem drives and controls the polystyrene cutting unit.

A study on the current situation in the biomedical technology and clinical engineering sector in Bulgaria--advances, trends and needs.

A survey of the clinical engineering sector in Bulgaria was carried out, within the context of the 1996 Phare Partnership Program, with the aim to provide a reflection of the current situation concerning the management of biomedical technology and investigate the relevant needs in hospitals. The survey was initiated by the Institute of Biomedical Technology (INBIT) in Patras, Greece, with the active support of national organizations, educational institutions and other parties that share involvement in the overall management of medical devices in Bulgaria. This paper summarizes the results of the survey, giving an insight into the situation in the field and providing the basis for a more thorough study on the Biomedical Technology and Clinical Engineering sectors in Bulgaria.

Development of a new Clinical Engineering Management Tool & Information System (CLE-MANTIS).

The evolution of the field of biomedical technology has led to the diffusion of an impressive number of medical devices into healthcare institutions. In this environment, Clinical Engineering Departments (CEDs) are expanding their role in healthcare technology management, by changing their structure and introducing quality systems in order to improve their services and monitor the outcomes. In the framework of the national project BIOTECHNET II, a software tool for the management of biomedical technology, named CLE-MANTIS, has been developed, with the aim to assist CEDs in their tasks.

A wavelet-based method for removal of out-of-plane structures in digital tomosynthesis.

Reconstructed images in digital tomosynthesis (DTS) are affected by artifacts due to blur from planes other than the fulcrum plane. A wavelet-based method has been developed for the discrimination and subsequent removal of unrelated structures from the reconstructed plane. The approach exploits both the specific pattern of noise in DTS and the spatial locality of the wavelet transformation.

Quality assurance in conformal radiotherapy: DYNARAD consensus report on practice guidelines.

Background And Purpose: Conformal radiotherapy has only recently been widely implemented. Although not all aspects have yet been adequately proven, it is generally recognized that maintaining a high degree of precision throughout the process is critical to the treatment outcome while the focus for quality assurance and quality improvement will need to concentrate more on human factors, procedures, communication, organization and training. A general consensus document on quality assurance guidelines for institutions that deliver conformal radiotherapy treatments to patients has been elaborated within the framework of the DYNARAD/BIOMED concerted action on conformal radiotherapy.

Computer assisted process management for health care: the IBIS tool.

IBIS is a broad range informatics tool, which can provide essential assistance to users during quality development projects in the health care environment. It can be used to set up a preliminary process model and specify variable and their interrelationships; the system propagates various quality related effects through the process structure, in a bottom up fashion, by linking quality indices to outcomes, repetitively, until arriving at the final outcome, at the top. An incorporated interactive browser is used to simulate the running process, to test and evaluate it, though a cause--effect interaction on intermediate or final outcomes.