The 14th Annual Croatian Cochrane Symposium, titled ‘What kind of research is needed for our health system?’ was held at the University of Split School of Medicine, in Split, Croatia, on 1st September, 2022. This hybrid event was organized as a platform for discussion on issues related to the improvement of primary and secondary health research, supporting evidence-based decision-making, and optimising collaboration between different stakeholders at national and international levels.
The opening address was given by Katarina Vukojević, the Vice Dean of the University of Split School of Medicine, and Ana Marušić, the Director of the Centre for Evidence Based Medicine, on behalf of Cochrane Croatia. Krešimir Dolić, the Deputy Director of the University Hospital of Split, started the Keynote session (moderated by Ana Marušić) with the presentation ‘What kind of research and what scientific evidence are needed for decision-makers and clinicians?’. He highlighted different factors influencing decision-making and stressed the need for evidence-based decision-making. He reminded participants that scientific evidence does not always have a large influence on decisions to adopt innovations in health care. For many decision-makers, experiential knowledge can be more relevant and applicable. He suggested that future research should continue to examine how evidence is used in making decisions, including how different types of evidence are legitimized and why some types are prioritized over others.
Flora Giorgio, the Deputy Head of Unit ‘Medical devices and HTA’ at the European Commission in DG Health (SANTE) spoke on ‘New EU HTA Regulation: Why it matters for national/regional HTA bodies and different stakeholders?’. She outlined the key principle of Regulation (EU) 2021/2282 on Health Technology Assessment (HTAR), the governance, joint HTA activities, as well as implementation timelines. Implementation of the HTAR is a priority for the Commission. Flora emphasised that commitment of Member States and stakeholders is essential to secure smooth implementation.
In the first Panel (moderated by Mirjana Huić), ’Why health technology assessment (HTA) is important for supporting evidence-based decision making on health technologies?’, the views on the importance of HTA for supporting evidence-based decision making on health technologies, the new EU Regulation on HTA, as well as the need and different methods for the appropriate patients’ involvement were discussed.
Claudia Wild, the Chief Executive Officer (CEO) of the Austrian Institute for HTA (AIHTA), Austria, in her presentation ‘HTA in Austria: National and international view’– talked about the AIHTAs role at the national and international level, especially in the European network for HTA (EUnetHTA), and recent collaborative activities in the COVID-19 pandemic. Preparedness for this new Regulation on HTA was discussed as well through the implementation concept for Austria. Claudia stressed that the international (European) HTA collaboration is of utmost necessity for small countries to cover a wide range of technologies and to stay up-to-date in methodologies. Implementation of the HTAR is challenging in decentralized countries: awareness of HTAR, coordination, flow of information, and possible centralization of decisions is needed.
Claudia was followed by François Houÿez, the Information & Access to Therapies Director & Health Policy Advisor of EURORDIS-Rare Disease Europe, who spoke on ‘Appropriate patient involvement in HTA: the view from EURORDIS’. François pointed to the importance of patient involvement in HTA, and how patients can be involved in joint clinical assessments (JCA) and joint scientific advices (JSA). He highlighted different methods for patient involvement, and provided some examples influencing the final decision. Education for patients and patient groups is key for appropriate involvement in the HTA process at the national and international level (JSC and JCA) after mandatory application of Regulation on HTA, in January 2025. The potential barriers of patient Involvement in HTA in Central and Eastern European countries were presented as well.
Mirjana Huić, HTA expert from the HTA/EBM Center, Zagreb, Croatia, presented ‘HTA in Croatia: Past, present and the future’. She pointed out how Croatia has been strengthening HTA capacities for systematic and sustainable HTA work at the national level and sustainable HTA collaboration at the EU level. Some HTA examples were presented. It is expected that the HTA process in Croatia will become a sustainable and mandatory part of the decision-making process on health technologies and that Croatia will actively participate in joint HTA work at the EU level.
The second Panel: What kind of clinical research is needed in the Croatian health system? (moderated by Tina Poklepović Peričić) presented the views of different stakeholders on conducting high-quality studies relevant for the Croatian health care system, the role of patients in clinical studies, the barriers to the availability of clinical studies in Croatia, as well as clinical research needed at the hospital level.
Ivan Buljan, from the Centre for Evidence-based Medicine, University of Split School of Medicine, Croatia, presented ‘How can the Centre for EBM help in conducting high-quality studies relevant for health care system?’. He described the structure of the Centre, recent projects relevant to the health care system, and the potential role of the Centre in narrowing the gap between research and practice.
Jasna Karačić, the president of the Croatian Association for the Promotion of Patients' Rights, Split, Croatia, in the presentation ‘What is the role of patients in clinical studies?’ pointed out that patient engagement is vital for clinical trial success, impacting everything from recruitment to advocacy. To recruit more diverse patients, a wider pool of patients needs to be engaged in clinical research as a concept. Effective communication is vital in ensuring patients are engaged. Good communication underpins the entire patient journey, reducing the chance of dropouts and increasing the chance of patients becoming active advocates for trial participation in future.
Mira Armour, director of the NGO Mijelom CRO, in her presentation ‘What are the barriers to availability of clinical studies in Croatia?’ talked about the reasons why it is important to have studies available from multiple myeloma patients’ perspective and shared findings on multiple myeloma clinical trials in Croatia and the region. She highlighted key barriers as well and ways for creating possibilities for access to clinical trials/studies, and why it is important for all stakeholders to work together with patients.
Ljubo Znaor, Head of the Research Unit, University Hospital of Split, in his presentation ‘What kind of clinical research is needed at the hospital level?’ emphasised that clinical research in the hospital setting is a valuable and powerful tool that is often neglected, offering the hospital many opportunities and challenges. Overall, it brings excellence and revenue diversification but it has to be gradually implemented as a new service to the public.
In the Poster presentation section, four early career researchers presented their work:
1. Marija Franka Žuljević. The Attitudes on Psychedelics Questionnaire (APQ): Validation of a new instrument for assessing attitudes on psychedelics in the general population.
2. Luka Ursić. Evidence behind policies, guidelines, and recommendations for the 2009 H1N1 and the COVID-19 pandemics: A cross-sectional study.
3. Nensi Ćaćić. Level of scientific evidence needed to make an informed decision about health among researchers, healthcare workers and consumers: a cross-sectional study.
4. Nora Rako. Financial transparency in line with the EFPIA code of practice among pharmaceutical companies in Croatia: Observational study.
The second part of the Symposium was a joint research workshop with ‘Professionalism in Health: Decision Making in Practice and Research’, a project funded by the Croatian Science Foundation. The workshop explored Case studies of patient involvement in HTA. It was moderated by François Houÿez and Mirjana Huić. The workshop covered: the background of HTA; four case studies of patient(s) involvement in HTA; EU Project Call for training of patient and clinical experts contributing to joint HTA activities; and the potential barriers of patient involvement in HTA in CEE countries. A mock-up exercise was held on the new pharmaceuticals for COVID-19 using the EUnetHTA draft document - Patient Input Template for Joint Clinical Assessments (JCA) as well. During the fruitful discussion, possible further actions and collaboration in the near future were explored.
Cochrane Croatia wishes to thank all on-line and on-site presenters, moderators and participants from the Croatian and international/regional health research communities, EBM and HTA experts, decision-makers, and representatives of professional medical and patient organizations, for sharing current scientific evidence, key points of the new EU regulation on HTA, challenges and opportunities related to the primary and secondary research for health system, and how to best support the evidence-based decision making and collaboration between different stakeholders. The fruitful discussion raised the importance of appropriate scientific research, as well as the need for continuous education and sustainable collaboration of different stakeholders at the national and the EU level.
Power Point presentations:
Implementation of the Regulation (EU) 2021/2282 on Health Technology Assessment
What kind of research and what scientific evidence are needed for decision makers and clinicians?
How can the Center for EBM help in conducting high-quality studies relevant for health care system?
Appropriate patient involment inHTA
What are the barriers to the availability of clinical studies in Croatia?
What kind of clinical research is needed at the hospital level?