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".

COVIDIAGNOSTIX: health technology assessment of serological tests for SARS-CoV-2 infection.

OBJECTIVE: In vitro diagnostic tests for SARS-COV-2, also known as serological tests, have rapidly spread. However, to date, mostly single-center technical and diagnostic performance's assessments have been carried out without an intralaboratory validation process and a health technology assessment (HTA) systematic approach. Therefore, the rapid HTA for evaluating antibody tests for SARS-COV-2 was applied. METHODS: The use of rapid HTA is an opportunity to test innovative technology. Unlike traditional HTA (which evaluates the benefits of new technologies after being tested in clinical trials or have been applied in practice for some time), the rapid HTA is performed during the early stages of developing new technology. A multidisciplinary team conducted the rapid HTA following the HTA Core Model® (version 3.0) developed by the European Network for Health Technology Assessment. RESULTS: The three methodological and analytical steps used in the HTA applied to the evaluation of antibody tests for SARS-COV-2 are reported: the selection of the tests to be evaluated; the research and collection of information to support the adoption and appropriateness of the technology; and the preparation of the final reports and their dissemination. Finally, the rapid HTA of serological tests for SARS-CoV-2 is summarized in a report that allows its dissemination and communication. CONCLUSIONS: The rapid-HTA evaluation method, in addition to highlighting the characteristics that differentiate the tests from each other, guarantees a timely and appropriate evaluation, becoming a tool to create a direct link between science and health management.

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.

[Exposure to hand-arm vibrations in orthopaedic plaster room: risk management]. / Esposizione a vibrazioni mano-braccio nel personale di sala gessi: risk management.

BACKGROUND: In hospitals, the use of vibrating tools, such as oscillating saws to cut plaster, can expose the staff to hand-arm vibrations. OBJECTIVES: The aim of the study was to assess the exposure of workers to vibrations in the plaster room and then  identify the most appropriate  intervention for  prevention and protection to be implemented in order to minimize  exposure and  protect  workers' health, considering different individual hyper-susceptibility conditions. METHODS: Four different models of plaster saws were examined for the evaluation.  Various measurements were made in normal working conditions of the operators. RESULTS AND CONCLUSIONS: The values of acceleration and noise detected on the instruments  were  in line with those reported in the literature. The preventive measure adopted (replacing plaster saws currently used in the hospital with similar ones with lower vibration emission) was an adequate means of protection. Health surveillance activities  recorded a higher level of wellbeing, both environmentally and individually and, specifically, an increased protection level for the hyper-susceptibility conditions observed during health checks of exposed personnel  which will be monitored regularly by the Occupational Health Service.

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.

Semiautomated external defibrillators for in-hospital early defibrillation: a comparative study.

OBJECTIVES: Semiautomated external defibrillators (AEDs) should be considered as a means to facilitate in-hospital early defibrillation (IHED) in areas where advanced life support rescuers are not readily available. In this study, we aimed to develop a checklist and a measurement protocol to evaluate and compare AEDs by assessing factors that may affect IHED. METHODS: A clinical and technical comparison of six AEDs was performed. Technical specifications were analyzed, while an emergency team evaluated ergonomics and appropriateness for IHED at Bambino Gesù Children's Hospital. A measurement protocol was implemented, which aimed to assess the ability of defibrillators to recognize shockable and nonshockable rhythms, accuracy of delivered energy, and charging time. RESULTS: Designs of AEDs differed in several features which influence their appropriateness for IHED. Some units showed poor ergonomics and instructions/feedback for cardiopulmonary resuscitation. Differences between defibrillators in recognizing shockable and nonshockable rhythms emerged for polymorphic ventricular tachycardia waveforms and when the frequency and amplitude of input signals varied. Tests for accuracy revealed poor performances at low and high impedance levels for most AEDs. Notably, differences greater than 20 seconds were found in the time from power-on to "ready for discharge." CONCLUSIONS: The approach we used to assess AEDs allowed us to evaluate their appropriateness with respect to the organizational context, to measure their parameters, and to compare models. Results showed that ergonomics and/or performances (timing and accuracy) could be improved in each device.

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.

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.