Fabrizio Pecoraro

Accessible Modelling of Complexity in Health (AMoCH) and associated data flows: asthma as an exemplar

Background Modelling is an important part of information science. Models are abstractions of reality. We use models in the following contexts: (1) to describe the data and information flows in clinical practice to information scientists, (2) to compare health systems and care pathways, (3) to understand how clinical cases are recorded in record systems and (4) to model health care business models. Asthma is an important condition associated with a substantial mortality and morbidity. However, there are difficulties in determining who has the condition, making both its incidence and prevalence uncertain. Objective To demonstrate an approach for modelling complexity in health using asthma prevalence and incidence as an exemplar. Method The four steps in our process are: Drawing a rich picture, following Checkland’s soft systems methodology; Constructing data flow diagrams (DFDs); Creating Unified Modelling Language (UML) use case diagrams to describe the interaction of the key actors with the system; Activity diagrams, either UML activity diagram or business process modelling notation diagram. Results Our rich picture flagged the complexity of factors that might impact on asthma diagnosis. There was consensus that the principle issue was that there were undiagnosed and misdiagnosed cases as well as correctly diagnosed. Genetic predisposition to atopy; exposure to environmental triggers; impact of respiratory health on earnings or ability to attend education or participate in sport, charities, pressure groups and the pharmaceutical industry all increased the likelihood of a diagnosis of asthma. Stigma and some factors within the health system diminished the likelihood of a diagnosis. The DFDs and other elements focused on better case finding. Conclusions This approach flagged the factors that might impact on the reported prevalence or incidence of asthma. The models suggested that applying selection criteria may improve the specificity of new or confirmed diagnosis.

Secondary uses of EHR systems: A feasibility study

This paper proposes a data warehouse architecture based on the Electronic Health Record (EHR) technological infrastructure developed in Italy. The adoption of EHRs can represent a possible solution to integrate data provided by different information sources transforming them into useful knowledge. This allows to define metrics and assessment of clinical performance as well as to take corrective actions to support better business decision-making. The paper describes the main advantages in the application of EHR for secondary purposes and reports the data warehouse design framework outlining its architecture as well as examples of business process dimensional models based on a set of clinical indicators defined to manage the intervention of patients with diabetes.

A Clinical Data Warehouse Architecture based on the Electronic Healthcare Record Infrastructure

The development of clinical data warehouses is becoming increasingly important in the healthcare domain to support organizations in the improvement of decision-making, business processes as well as the communication between clinicians, patients and the administration. However, data and process integration is a big challenge considering the heterogeneous and distributed nature of healthcare information systems. This paper proposes a data warehouse architecture based on the Italian Electronic Health Record (EHR) technological infrastructure. It describes the main advantages in the application of EHR systems for secondary purposes and reports the data warehouse design framework outlining its architecture as well as a dimensional model based on a dashboard defined to manage the intervention of patients with diabetes. The adoption of EHR systems enhances interoperability given that these systems share standardized clinical data among multiple parties involved in different healthcare settings.

Principles for provision of integrated complex care for children across the acute–community interface in Europe

This Viewpoint presents and discusses the development of the first core principles and standards for effective, personalised care of children living with complex care needs in Europe. These principles and standards emerged from an analysis of data gathered on several areas, including the integration of care for the child at the acute-community interface, the referral-discharge interface, the social care interface, nursing preparedness for practice, and experiences of the child and family. The three main principles, underpinned by a child-centric approach, are access to care, co-creation of care, and effective integrated governance. Collectively, the principles and standards offer a means to benchmark existing services for children living with complex care needs, to influence policy in relation to service delivery for these children, and to provide a suite of indicators with which to assess future service developments in this area.

A conceptual model for integrating social and health care services at home: The H@H project

The increasing demand for home care due to the growing number of older people with an increased incidence of multiple chronic conditions requires the adoption of technological innovation that can improve the integration and coordination of health and social services. This paper presents the H@H platform that aims to improve the coordination and cooperation among stakeholders facilitating the provision of care services in a continuity of care framework. Moreover, a conceptual model that combines the main concepts of the ContSys standard with social care components and with assistive domotics linked to the lifestyle and healthy behavior is proposed. Finally, a scenario that depicts the application of the integrated approach to a subject affected from metabolic syndrome is presented.

A methodology of healthcare quality measurement: A case study

In this paper we present a comprehensive model for quality assessment taking into account structure, process and outcome dimensions introduced in the Donabedian framework. To test our hypothesis a case study based on the Italian healthcare services is reported focusing on the analysis of the hospital bed management and on the phenomenon of both active and passive patient mobility.

Integrating CERIF Entities in a Multidisciplinary e-infrastructure for Environmental Research Data☆

Abstract The paper proposes different solutions to integrate CERIF in the environmental dataset domain, based on the quality of semantic mapping as well as on the characteristics of the CERIF data model. A two-way crosswalk is described resulting in the identification of a core of corresponding metadata and a proposal of extensions of the CERIF model. Extensions of ISO concepts are also described to provide contextual research information in the domain of environmental research data. Finally, the crosswalk has been implemented in the GI-cat discovery broker framework. Successful tests demonstrated the possibility for CERIF information to be integrated in ISO compliant infrastructures and for INSPIRE information to be captured in CERIF.

The Integration of the Risk Management Process with the Lifecycle of Medical Device Software

OBJECTIVES The application of software in the Medical Device (MD) domain has become central to the improvement of diagnoses and treatments. The new European regulations that specifically address software as an important component of MD, require complex procedures to make software compliant with safety requirements, introducing thereby new challenges in the qualification and classification of MD software as well as in the performance of risk management activities. Under this perspective, the aim of this paper is to propose an integrated framework that combines the activities to be carried out by the manufacturer to develop safe software within the development lifecycle based on the regulatory requirements reported in US and European regulations as well as in the relevant standards and guidelines. METHODS A comparative analysis was carried out to identify the main issues related to the application of the current new regulations. In addition, standards and guidelines recently released to harmonise procedures for the validation of MD software have been used to define the risk management activities to be carried out by the manufacturer during the software development process. RESULTS This paper highlights the main issues related to the qualification and classification of MD software, providing an analysis of the different regulations applied in Europe and the US. A model that integrates the risk management process within the software development lifecycle has been proposed too. It is based on regulatory requirements and considers software risk analysis as a central input to be managed by the manufacturer already at the initial stages of the software design, in order to prevent MD failures. CONCLUSIONS Relevant changes in the process of MD development have been introduced with the recognition of software being an important component of MDs as stated in regulations and standards. This implies the performance of highly iterative processes that have to integrate the risk management in the framework of software development. It also makes it necessary to involve both medical and software engineering competences to safeguard patient and user safety.

The HL7 RIM in the Design and Implementation of an Information System for Clinical Investigations on Medical Devices

The paper describes MEDIS (Medical Device Information System), a system developed to support the whole lifecycle of a Clinical Investigation (CI) for Medical Devices, providing details on the approach used in its development. MEDIS is a software system that collects and manages data and documents, exchanged between an applicant and the Italian National Competent Authority during all the phases of the business process, from the CI notification up to the submission of the final results. The development of the MEDIS Domain Analysis Model (DAM) following the HL7 v.3 methodology as well as the approach followed in the system implementation are discussed in relation to the business domain peculiarities.

A methodology to identify health and social care web services on the basis of case stories

There is an increasing adoption of Service-oriented architecture (SOA) to develop interoperable open platforms that integrate heterogeneous information systems in healthcare. One of the challenging tasks in the SOA design is the identification of web services to be implemented, that is usually based on business process modelling. This paper presents a comprehensive and consistent methodology able to detect all functional requirements and web services based on the analysis of case stories built using semi-structured interviews to the different stakeholders involved in the care process. These narrative descriptions are the starting point to define a formal pictorial representation using the Unified Modelling Language (UML) use case and sequence diagrams that allow analysts and programmers to identify web services to be implemented to support the communication between subjects (patient, providers) and objects (device, systems) in real-life contexts. This methodology has been adopted within the Health@Home project that provides a technological and organizational solution to support both citizens and organizations in the provision of health and social services in the home setting.