Health technology assessment to employ COVID-19 serological tests as companion diagnostics in the vaccination campaign against SARS-CoV-2.

OBJECTIVES: In scenarios of vaccine scarcity or contexts of organizational complexity, it is necessary to define prioritization strategies for allocating vaccine doses in compliance with the criterion of equity and efficiency of health resources. In this context, the COVIDIAGNOSTIX project, based on the health technology assessment (HTA), assessed the role of SARS-CoV-2 serological tests as a companion diagnostic in the definition of the vaccination strategies for the vaccine administration. To guarantee evidence support for health policy choices, two different vaccine strategies were analyzed, one based on administering the vaccine booster dose to the entire population (VACCINE strategy) and the other based on allocation criteria (TEST&VACCINE strategy). METHODS: The decision-oriented HTA (DoHTA) method, integrated with specific modeling and simulation techniques, helped define the perimeter to make health policy choices. RESULTS: The processing of the scores attributed to the key performance indicators concerning all the evaluation domains shows a performance of 94.34% for the TEST&VACCINE strategy and 83.87% for the VACCINE strategy. CONCLUSIONS: TEST&VACCINE strategy can be the most advantageous in various scenarios due to greater speed from an operational and an economic point of view. The assessment schemes defined by COVIDIAGNOSTIX (i.e., technologies/intended use/settings) can easily and quickly be exported and adapted to respond to similar health "policy questions".

Health Technology Assessment of Intensive Care Ventilators for Pediatric Patients.

This paper is aimed at addressing all the critical aspects linked to the implementation of intensive care ventilators in a pediatric setting, highlighting the most relevant technical features and describing the methodology to conduct health technology assessment (HTA) for supporting the decision-making process. Four ventilator models were included in the assessment process. A decision-making support tool (DoHTA method) was applied. Twenty-eight Key Performance Indicators (KPIs) were identified, defining the safety, clinical effectiveness, organizational, technical, and economic aspects. The Performance scores of each ventilator have been measured with respect to KPIs integrated with the total cost of ownership analysis, leading to a final rank of the four possible technological solutions. The final technologies' performance scores reflected a deliver valued, contextualized, and shared outputs, detecting the most performant technological solution for the specific hospital context. HTA results had informed and supported the pediatric hospital decision-making process. This study, critically identifying the pros and cons of innovative features of ventilators and the evaluation criteria and aspects to be taken into account during HTA, can be considered as a valuable proof of evidence as well as a reliable and transferable method for conducting decision-making processes in a hospital context.

A comparative cost analysis of robotic-assisted surgery versus laparoscopic surgery and open surgery: the necessity of investing knowledgeably.

BACKGROUND: Robotic surgery has been proposed as a minimally invasive surgical technique with advantages for both surgeons and patients, but is associated with high costs (installation, use and maintenance). The Health Technology Assessment Unit of the Bambino Gesù Children's Hospital sought to investigate the economic sustainability of robotic surgery, having foreseen its impact on the hospital budget METHODS: Break-even and cost-minimization analyses were performed. A deterministic approach for sensitivity analysis was applied by varying the values of parameters between pre-defined ranges in different scenarios to see how the outcomes might differ. RESULTS: The break-even analysis indicated that at least 349 annual interventions would need to be carried out to reach the break-even point. The cost-minimization analysis showed that robotic surgery was the most expensive procedure among the considered alternatives (in terms of the contribution margin). CONCLUSIONS: Robotic surgery is a good clinical alternative to laparoscopic and open surgery (for many pediatric operations). However, the costs of robotic procedures are higher than the equivalent laparoscopic and open surgical interventions. Therefore, in the short run, these findings do not seem to support the decision to introduce a robotic system in our hospital.

Decision-Oriented Health Technology Assessment: One Step Forward in Supporting the Decision-Making Process in Hospitals.

OBJECTIVES: This article outlines the Decision-Oriented Health Technology Assessment: a new implementation of the European network for Health Technology Assessment Core Model, integrating the multicriteria decision-making analysis by using the analytic hierarchy process to introduce a standardized methodological approach as a valued and shared tool to support health care decision making within a hospital. METHODS: Following the Core Model as guidance (European network for Health Technology Assessment. HTA core model for medical and surgical interventions. Available from: http://www.eunethta.eu/outputs/hta-core-model-medical-and-surgical-interventions-10r. [Accessed May 27, 2014]), it is possible to apply the analytic hierarchy process to break down a problem into its constituent parts and identify priorities (i.e., assigning a weight to each part) in a hierarchical structure. Thus, it quantitatively compares the importance of multiple criteria in assessing health technologies and how the alternative technologies perform in satisfying these criteria. The verbal ratings are translated into a quantitative form by using the Saaty scale (Saaty TL. Decision making with the analytic hierarchy process. Int J Serv Sci 2008;1:83-98). An eigenvectors analysis is used for deriving the weights' systems (i.e., local and global weights' system) that reflect the importance assigned to the criteria and the priorities related to the performance of the alternative technologies. RESULTS: Compared with the Core Model, this methodological approach supplies a more timely as well as contextualized evidence for a specific technology, making it possible to obtain data that are more relevant and easier to interpret, and therefore more useful for decision makers to make investment choices with greater awareness. CONCLUSIONS: We reached the conclusion that although there may be scope for improvement, this implementation is a step forward toward the goal of building a "solid bridge" between the scientific evidence and the final decision maker's choice.

Adopting European Network for Health Technology Assessments (EunetHTA) core model for diagnostic technologies for improving the accuracy and appropriateness of blood gas analyzers' assessment.

BACKGROUND: Point-of-care testing (POCT) is a successful methodology for meeting clinical expectations of rapid and accurate results. Scientific literature has moreover highlighted and confirmed the necessity of individuating the best technological solution, in accordance with clinical requirements and contextualized to the whole health organization, where it will be implemented. Health Technology Assessment (HTA) can assist in reaching an appropriate and contextualized decision on a health technology. The aim of this study is to adapt a HTA core model for improving the evaluation of a POCT technology: blood gas analyzers. METHODS: The European Network for Health Technology Assessment (EUnetHTA) core model for diagnostic technologies was applied for evaluating globally marketed blood gas analyzers. Evaluation elements were defined according to available literature and validated using the Delphi method. RESULTS: A HTA model of 71 issues, subdivided into 26 topics and 10 domains, was obtained by interviewing 11 healthcare experts over two rounds of Delphi questionnaires. Ten context parameters were identified in order to define the initial scenario from which the technology assessment was to begin. CONCLUSIONS: The model presented offers a systematic and objective structure for the evaluation of blood gas analyzers, which may play a guidance role for healthcare operators approaching the evaluation of such technologies thus improving, in a contextualized fashion, the appropriateness of purchasing.

Supporting clinical engineering in Italy: results of a survey conducted by the AIIC.

This article presents the outcomes of a survey developed and conducted by the Italian Association of Clinical Engineers (AIIC) in 2010 [1]. The AIIC, affiliated with the International Federation for Medical and Biological Engineering (IFMBE) since 2003, conducted this in-depth survey to investigate the educational profile of clinical engineers (CEs) as well as the activities and organization of clinical engineering departments (CEDs) in Italy. The survey consisted of a six-section questionnaire designed by the AIIC Board, which was based on other previous international surveys of CEDs. The questionnaire was sent to the AIIC members and to the most important Italian health-care organizations.