Health Technology Assessment “is the comprehensive and systematic multidisciplinary assessment (description, examination and appraisal) of welfare, economic, social and ethical consequences directly and indirectly caused, in the short and long term, by existing health technologies and by the new ones introduces. traditionally, it represents the bridge between the technical–-scientific world and that one of the decision makers” (Trento Charts on Health Technology Assessment, 2003).
Over the time HTA has assumed an increasingly prominent role in decisions about the high-tech activities governance (prevention programs, medications, diagnostic tests, medical devices, clinical and care procedures), and for general decisions (marketing, reimbursement and performances guarantees), both for the practical introduction of technology in hospitals and in clinical practice.
The involvement of stakeholders in general and citizens in particular, in the literature of the field, is considered integral part of the processes of the Health Technology Assessment. On the other hand, the actual inclusion of these “actors” and their point of view in the evaluation process is, generally, well below the recommended level, although there are some exceptions such as the Patient and Public Involvement Program (PPPI) provided by the English National Institute for Clinical Excellence (NICE).
This does not only depends on the lack of a public policy on the subject, but also by a delay of understanding and by a gap about the knowledge from the civic leadership. In this context the Association Health Equality Europe (HEE) has produced a guide to participation, “Understanding Health Technology Assessment”, given to citizens and patients associations where a particular attention is devoted to “evidence of patients” and that is the need to collect citizens experiences and enforce them in the evaluation process, both in the strictly clinical side (particularly the collateral effects), both on the factors associated with quality of life. The guide is primarily applied to civic organizations considered in a dual role:
- as agents helping the sick in the formulation of evidence and in the communication with the evaluators;
- as “political actors who can (and should) intervene in the reality where the Health Technology Assessment approach is absent or used in partial and insufficient ways.
This recommendation, more generally, also corresponds to the need to enhance the formation of a “user, strong and able to interact in authoritative and appropriate way with the health services and with the building of clinical governance” detected in the conclusions of the Report on the Implementation of European Charter of Patients’ Rights presented in 2011 by Active Citizenship Network, the European Cittadinanzattiva. In the essence a new request of qualified participation emerges that is engaging Cittadinanzattiva in the design of initiatives to address to the civic leadership on various topics.
The participation in the work of the Health Policy Forum enabled Cittadinanzattiva and the Italian Society for the Health Technology Assessment (SIHTA) to share the evaluations on the relevance of the problem and the need to implement an adequate corrective action. During the inaugural session of the Fourth National SiHTA Congress – which took place November 17, 2011 in Udine – the two organizations, signed then an agreement for the promotion of a Summer School for civic leaders about HTA to implement in collaboration with Agenas.
The overall aim of the project is to facilitate the implementation of an Italian model of citizen involvement in all stages of, through the implementation of a pilot training course of civic leaders of patient organizations.
Mostly, the specific aims of the Summer School are:
- establish a core group of civic leaders that, starting from this educational experience, become a community that could be a driving force on the HTA for the spread of citizens empowerment about the subject;
- facilitate the acquisition of knowledge about the terminology used in HTA, to the mechanisms that regulate its production process, to the institutional context and to people that in Italy are involved in HTA;
- facilitate the participants to the acquisition of skills and functional capabilities of taking a more aware and active role in the different phases of the HTA process, with particular attention on the collecting and formalization of the patients’ evidences;
- facilitate the “training” to the participants on the comparison of the point of views of the different actors involved in the HTA process.
METHODOLOGY: methods and tools
From the point of view of the training, the framework is the experience of HTA Patient Academy, created by the London School of Economics.
This last aspects refers to the centrality of citizens’ role – as co-actors – in every moment of the appraisal cycle technologies, both the assessment and the appraisal, ie not only during the “detection of the evidence of the patients”, but throughout the process definition and discussion of a recommendation.
The course will have a pilot character for at least two elements:
- the first one is exactly given by the unique experience compared to the target: until now the provision of training on HTA has primarily focused on the professionals target; Summer School, on the exemple of the London School experience, wants to primarily address with leaders of civic organizations;
- the second element is given by the intent of making reproducible the initiative, promoting thus the involvement of the same target in the course evaluation for the wider dissemination of this learning process.
Summer School will be developed in two residential training modules for a total of 40 hours and will cover topics connected to different thematic blocks. The first module is scheduled from 5th to 7th of September 2013, the second one from 26th to 28th of September 2013.
The first block is themed on the introduction of the Health technology assessment and then will deal with:
- the clarification of the scope of HTA;
- the reasons that led to the development of the HTA;
- the terminology used and the key elements of the process of HTA;
- the role and the importance of the various stakeholders. Patients and their organizations.
The second block, more detailed, the practical conduct of HTA processes with a particular attention to the evidence studied, to the analysis of the costs and the outcomes and to assessment models taken from Italian agencies.
The third block concerns the mode of action of stakeholders and, in particular, of the civic organizations in the assessment phase: general relations agencies, collection and reporting of patients’ evidence, formulation of advices and participation to consultation groups. In particular we will refer to the experience of Nice, to the recommendations of the Health Equality Europe and the practices adopted by EMA.
Finally, the fourth block is concerned the mode of action of stakeholders and, in particular, of civic organizations in the process of appraisal: analysis of recommendations and of the various factors involved in final decisions.
The prior information of the participants will be particularly treated, with the supply of material and in particular the text of recommendations from Health Equality Europe.
In the first residential module we will use a methodology that will see the alternating moments of lectures and interactive teaching moments, keeping a constant attention to the centrality of the experience of participants. This experience will be collected by the trainers during a continuous “Socratic” exchange with the group and it will be used and developed during the course (in its various phases) as a stimulus to lead the group and initiate learning through active learning techniques such as simulations, exercises, brainstorming, case studies, exchange of experiences of the constructive interaction between different parties, planning civic intervention in HTA.
We provides the comparison of participants with the European experience of HTA and the involvement of patients in this process by the presence during the course of two Visiting Professor.
In the interval between the first and the second residential module, participants will be undertaken to apply the knowledge gained to their own experience evaluating the opportunities offered by the HTA approach and the emerging critical.
Even the second residential module will have a strongly interactive character with the comparison among the participants on the basis of the valuations referred to above, with the generation of evidence by patients and the simulation/testing of moments of assessment and appraisal. It is expected the participation of experts from the regions where the HTA is active.
Identification of participants
The identification of the participants will be supervised by Cittadinanzattiva, it will be based on strict criteria, with particular reference to:
- the experience and expertise gained from the activities at civic organizations active in the field of health;
- the verification of a cultural level sufficient to ensure the technical understanding of the covered topics;
- the interest in reforming the mode of operation of the membership organization in the areas covered by HTA .
Teaching team and directions of the course.
The design and the guidelines for the conduct of the course will be expressed by a Steering Committee attended by sponsoring institutions and organizations. A joint scientific coordination will coordinate content and processing also to the production of material and publications.
The educational coordination will be maintained by Cittadinanzattiva.
The Steering Committee will ensure the identification of teachers as part of the national Agencies and SiHTA, to the identification of Visiting Professor and regional experts of HTA.
OUTPUT OF THE PROGETTO
At the end of the project will be available:
- Twenty-five formed civic leaders;
- A reference format for the collection of evidence of the patients e for the other forms of civic intervention;
- A training program about HTA for civic leaders, “tested” and reproducible;
- A final report that will be used by agencies for the conduct of their activities.
For more information, please write to Daniela Mondatore:
Year: 2013 (II edition)
Project realized in partnership with:
Age.Na.S. (Agenzia nazionale per i servizi sanitari regionali)
SiHTA (Società Italiana di Health Tecnology Assessment)
FIASO (Federazione italiana aziende sanitarie e ospedaliere)