Understanding of the role of contextual factors in determining the real value of health technologies is one of the major challenges for the use of Health Technology Assessment (HTA) methodology within hospitals. Moreover, the responsibility of assessing hospital performance is problematic. Although a number of managerial tools are available to appraise outcomes, there is little evidence on the role of contextual variables and how they might contribute to hospital performance.

Based on three extensive literature reviews, a pragmatic framework has been developed to understand interactions between organizational factors and health technologies on hospitals’ performance. Three main causal relationships emerge: (i) direct relationship between contextual factors and performance; (ii) an effect of contextual factors on the capability of technologies to “produce value”; (iii) an influence of organizational factors on clinical evidence-based decision-making. This pragmatic framework was designed within the IMPACT HTA EU Horizon 2020 Research Project.

The contextual dimensions are ascribable to five domains: organizational structure; managerial accounting tools; information, communication and technology (ICT) tools; human resource management (HRM) tools; hospital-based HTA procedures. The impact of contextual factors on technologies’ ability to produce value is highly overlooked in literature. Some effort in this sense exists only in the analysis of health information technologies. Moreover, among the contextual dimensions, only HRM tools have inspired a lively debate. The definition of hospital performance is amenable to multiple domains: accessibility, appropriateness, efficiency, safety and patient centeredness (continuity of care).

Although hospital performance is a pivotal topic in the healthcare sector, a deep understanding of how contextual factors may affect it is missing. The theoretical framework developed provides a tool to understand the multiple dimensions able to affect hospital performance. On one hand contextual dimensions may provide a direct effect on hospital performance. On the other, they may affect the extent to which technologies are capable of producing value.

In Italy, the central government sets the health benefit package (denominated “Livelli Essenziali di Assistenza” - LEAs) of the National Health System (NHS), which must be provided to all residents. In 2004, the Italian Ministry of Health established a new technical body, the National LEA Commission, responsible for updating LEAs.

Recently, the Ministry has commissioned to the National Institute of Health (NIH) the development of a new value-based procedure for updating the health benefit package for the Italian NHS, supporting the National LEA Commission. A review and comparison of value frameworks and decisional models was performed in order to select a framework and a model that can be applied to the Italian context, design an administrative process for the update procedure, and propose approaches for: (i) the assessment of services currently included in the health benefit basket and of those planned to be incorporated, (ii) the process of appraisal and decision-making to be adopted by the Commission.

The NIH outlined an evidence and value-based three-step (i.e. priority setting, assessment and appraisal) administrative process that integrates roles and responsibilities of the different Italian healthcare institutions involved in LEA updating and HTA.

The NIH is proposing to the Ministry of Health and to the National LEA Commission a new evidence and value-based procedure for updating the health benefit package for the Italian NHS. This procedure is entering a pilot phase in which potential gaps can be identified and minimized for its subsequent implementation.

Acute myocardial infarction (AMI) is one of the leading causes of death and disability worldwide. The European Society of Cardiology Guidelines have established a new definition of myocardial infarction and have strengthened the central role of cardiac troponins in cardiology diagnostics for rule-in and rule-out of non ST-elevation myocardial infarction (NSTEMI). High-sensitivity cardiac troponin I assays (hsTnI) should increase diagnostic sensitivity, and a shorter interval for ruling-in and ruling-out AMI. This analysis aims to provide an overview of the clinical, economic, organizational and ethical impact of the use of hsTnI in clinical practice of Emergency Departments (ED) in Italy.

HsTnl for rule-in and rule-out of AMI in the ED is being evaluated using the EUnetHTA Core Model® framework for health technology assessment. The hsTnI HTA assessment will be completed with real-world evidence derived from a multicenter observational study which has been designed to be conducted in 12 Italian EDs, enrolling 6000 patients with chest pain of suspected cardiac origin, aiming to provide data from the Italian context on clinical, organizational and economic aspects of the use of the test in the ED. Endpoints of the study include: time lapses related to diagnosis, admission, treatment and discharge of patients; number of tests performed; and number of patients diagnosed with AMI.

Initial results from a literature review confirm the usefulness of the hsTnI assay in diagnosing AMI. Generated real-world data will be collected, analyzed and integrated to existing evidence to assess the utility of the test in real contexts, providing details relevant for organizational aspects of the use of the test in the ED.

The use of hsTnl could improve diagnosis of AMI by allowing a faster ruling-in or ruling-out, and reducing inappropriate hospitalizations. Furthermore, this technology could represent an opportunity to reduce overall costs for the healthcare system.