The HTA Core Model®-10 Years of Developing an International Framework to Share Multidimensional Value Assessment.

BACKGROUND AND OBJECTIVES: The HTA Core Model® as a science-based framework for assessing dimensions of value was developed as a part of the European network for Health Technology Assessment project in the period 2006 to 2008 to facilitate production and sharing of health technology assessment (HTA) information, such as evidence on efficacy and effectiveness and patient aspects, to inform decisions. METHODS: It covers clinical value as well as organizational, economic, and patient aspects of technologies and has been field-tested in two consecutive joint actions in the period 2010 to 2016. A large number of HTA institutions were involved in the work. RESULTS: The model has undergone revisions and improvement after iterations of piloting and can be used in a local, national, or international context to produce structured HTA information that can be taken forward by users into their own frameworks to fit their specific needs when informing decisions on technology. The model has a broad scope and offers a common ground to various stakeholders through offering a standard structure and a transparent set of proposed HTA questions. It consists of three main components: 1) the HTA ontology, 2) methodological guidance, and 3) a common reporting structure. It covers domains such as effectiveness, safety, and economics, and also includes domains covering organizational, patient, social, and legal aspects. There is a full model and a focused rapid relative effectiveness assessment model, and a third joint action is to continue till 2020. CONCLUSION: The HTA Core Model is now available for everyone around the world as a framework for assessing value.

Collaborative models for the joint production of core health technology assessments: negative and positive aspects for the joint work of different European agencies.

OBJECTIVES: The purpose of the European network for Health Technology Assessment (EUnetHTA) is to make HTA agencies collaborate sharing methods and tools thus avoiding duplication of evaluative efforts and allowing resource savings. From 2010 to 2012, the activities of the network were carried out through EUnetHTA Joint Action 1 and Work Package 4 Strand B aimed at producing two Core HTAs with two main objectives: to test the Web based Core model and the collaborative working models. Our objective in this article is to give an historical record of the Work Package activities highlighting what worked and what did not in the collaboration of researchers' groups coming from different agencies. METHODS: A retrospective description of all the steps for the joint production of the two Core HTAs is provided starting from the first step of selecting technologies of common interest. Primary researchers' views on the whole process have been collected through a semi-structured telephonic interview supported by a questionnaire. Coordinators views were gathered during internal meetings and validated. RESULTS: Majority of respondents thought topic selection procedure was not clear and well managed. About collaborative models, small groups were seen to enable more exchange, whatever the model. According to coordinators, loss of expertise and experience during the production process, different languages, and novelty of the Online Tool were main barriers. CONCLUSIONS: Lessons learned from this first experience in Joint Action 1 paved the path for the collaboration in Joint Action 2, as it allowed enhancements and changes in models of collaborations and coordination.

Developing the HTA core model for the online environment.

BACKGROUND: A framework for collaborative production and sharing of HTA information, the HTA Core Model, was originally developed within EUnetHTA in 2006-08. In this paper, we describe the further development of the Model to allow implementation and utilization of the Model online. The aim was to capture a generic HTA process that would allow effective use of the HTA Core Model and resulting HTA information while at the same time not interfering with HTA agencies' internal processes. METHODS: The work was coordinated by a development team in Finland, supported by an international expert group. Two pilot testing rounds were organized among EUnetHTA agencies and two extensive core HTA projects tested the tool in a real setting. The final work was also formally validated by a group of HTA agencies. RESULTS: The HTA Core Model Online--available at http://www.corehta.info--is a web site hosting a) a tool to allow electronic utilization of the HTA Core Model and b) a database of produced HTA information. While access to the HTA information is free to all, the production features are currently available to EUnetHTA member agencies only. A policy was crafted to steer the use of the Model and produced information. CONCLUSIONS: We have successfully enabled electronic use of the HTA Core Model and agreed on a policy for its utilization. The system is already being used in subsequent HTA projects within EUnetHTA Joint Action 2. Identified shortcomings and further needs will be addressed in subsequent development.

How does emotional intelligence act on institutional policies? A new set of behaviors to facilitate implementation of the Recovery and Resilience Plan (RRP) in local health units in Italy.

BACKGROUND: The main contribution of this article is establishing a set of behaviors and successful actions experimenting the Ipacs' (Institutional & Public Coaching Services) methodology on implementation of the National Recovery Plan (NRP), approved in Italy in 2021 to overcome the socio-economic impact of the pandemic. This research is aimed at pointing out emotional intelligence (EI) behaviors related to the activities of the NRP with respect to the National Health System (NHS). PARTICIPANTS AND PROCEDURE: Fifty-six professionals were provided with an integrated pathway with coaching, participative art and mentoring from January to June 2022. A "core set" of 5 soft skills - communication, result orientation, teamwork, networking, and emotional intelligence - was measured before and after an integrated coaching pathway. Each soft skill related to the following three systemic objectives through pre-defined, related activities: 1) defining and introducing new roles in the health community houses; 2) implementing a new systemic communication in oncology; 3) facilitating the management of chronicity through a new IT platform. We observed that the Giunti test (Org-EIQ) and Ipacs' test enlighten the same emotional intelligence indicators of behaviors considered by the investigated coaching integrated pathway. RESULTS: Forty-eight percent of them increased in all 5 core skills. Results were measured at least in one of the two tests. These results were possible thanks to the changes in abilities of self- introspection, in communicating and sharing common goals, to achieve high standard results in conditions of uncertainty, to understand non-verbal feedback and give feedback. CONCLUSIONS: Emotional intelligence acted as a meta skill to pursue a "new model of man" with a new self-schema, self-image and set of behaviors.

Implementing a national early awareness and alert system for new and emerging health technologies in Italy: the COTE Project.

OBJECTIVES: The aim of this study was to establish a national Early Awareness and Alert (EAA) system for the identification and assessment of new and emerging health technologies in Italy. METHODS: In 2008, Agenas, a public body supporting Regions and the Ministry of Health (MoH) in health services research, started a project named COTE (Observatory of New and Emerging Health Technologies) with the ultimate aim of implementing a national EAA system. The COTE project involved all stakeholders (MoH, Regions, Industry, Universities, technical government bodies, and Scientific Societies), in defining the key characteristics and methods of the EAA system. Agreement with stakeholders was reached using three separate workshops. RESULTS: During the workshops, participants shared and agreed methods for identification of new and emerging health technologies, prioritization, and assessment. The structure of the Horizon Scanning (HS) reports was discussed and defined. The main channels for dissemination of outputs were identified as the EuroScan database, and the stakeholders' Web portals. During the final workshop, Agenas presented the first three HS reports produced at national level and proposed the establishment of a permanent national EAA system. CONCLUSIONS: The COTE Project created the basis for a permanent national EAA system in Italy. An infrastructure to enable the stakeholders network to grow was created, methods to submit new and emerging health technologies for possible evaluation were established, methods for assessment of the technologies selected were defined, and the stakeholders involvement was delineated (in the identification, assessment, and dissemination stages).

Wireless capsule endoscopy in Italy: adding context-specific data to the review of the evidence from literature.

OBJECTIVES: The aim of this study was to assess the evidence of diagnostic accuracy of the wireless capsule for endoscopy (WCE) for the diagnosis of obscure gastrointestinal bleeding (OGIB) and small bowel disease in adults and translate it to the context of the Italian National Health Service. METHODS: We performed a systematic review of secondary and primary literature. We reviewed WCE diagnostic accuracy, safety, economic evaluations for OGIB. Context-specific data about WCE diffusion, costs, appropriateness of WCE use were collected by means of a national survey involving all Italian gastroenterological departments. RESULTS: We updated the systematic review of the most recent health technology assessment report (2006). Our review shows lack of robust comparative evidence of diagnostic accuracy of WCE. The studies' design do not allow collection of reliable evidence due to the uncertainty surrounding morphological variability of bleeding vascular gut lesions. The national survey reported widespread WCE use and data on appropriateness and costs. CONCLUSIONS: Evidence of WCE diagnostic accuracy is of low quality, and there is a requirement for randomized comparisons. Our findings raise the issue of technology governance and show the importance of an assessment before the technology being widely commercialized.

Implantable devices for the closure of patent foramen ovale in adults: an Italian rapid health technology assessment.

Percutaneous closure of patent foramen ovale (PFO) is offered to patients suffering from cryptogenic stroke, transient ischemic attack or persistent migraine. Several PFO closure devices are CE marked but none have yet been approved by the FDA. On the Italian market 11 different PFO closure devices are available and more than 2500 PFO procedures were reported in 2012. We report findings of a systematic review and meta-analysis of studies in which patients with PFO and transient ischemic attacks, cryptogenic stroke or persistent migraine who underwent PFO closure were compared to patients treated by usual care. We included five controlled clinical trials and one randomized controlled trial. Included studies had poor methodological quality and heterogeneity. In the included randomized controlled trial, 4.7% of procedure-related serious adverse events were observed. Large multicenter, sufficiently powered, and properly randomized trials need to be conducted in Europe with particular attention to patient selection.

Health Technology Assessment: managing the introduction and use of medical devices in clinical practice in Italy.

Technology assumes a key role in current clinical practice. A number of innovative or improved products are constantly being launched on the market and offered directly to the users (i.e., clinicians) or even to the patients. However, in most cases, the regulation for admission to commerce is slower than the innovation process and may be inadequate for assessing the real clinical effectiveness and safety of medical devices in the premarket phase. Health Technology Assessment (HTA) can be used as a tool for the evaluation of clinical effectiveness, cost-effectiveness and risk to patients of medical devices. HTA products (e.g., periodic reports) may aid healthcare payers to make informed choices regarding the appropriate use, coverage and reimbursement of medical devices. We present the strengths and limitations of the first three Italian HTA reports we coauthored and critically explore some of the aspects related to the introduction, adoption and use of medical technologies in clinical practice.