Towards an integrated assessment of complex health interventions. Results of the European INTEGRATE-HTA project

INTEGRATE-HTA, an innovative research project was co-funded by the European Union (EU) under the Seventh Frame¬work Programme from January 2013 until December 2015. This project developed concepts and methods that enable a patient-centred, comprehensive, and integrated assessment of complex health technologies which were applied in a palliative care case study. The practical guidances are available through the project website www.integrate-hta.eu. Introduction: background and objectives: In recent years there have been major advances in the development of health technology assessment (HTA). However, HTA still has certain limitations when assessing technologies which: - are context-dependent, as current HTA focusses on the health technology, not on the (socio-cultural, healthcare) system within it is used; - perform differently depending on the way they are implemented; - may have different effects on different patients/consumers. Furthermore, HTA usually assesses and appraises aspects side-by-side while decision-making needs an integrated perspective on the value of a health technology. In the EU-funded INTEGRATE-HTA project, we (a Consortium of seven partners from five different European countries: Germany, Italy, The Netherlands, Norway, United Kingdom) developed concepts and methods to deal with these challenges. As the rise in chronic diseases in ageing populations has led to the development of increasingly complex technologies, we used palliative care as a case study to test the concepts and methods. Methods:Different approaches were used to develop guidances on how to conduct an integrated assessment of a complex health technology. These include building on existing concepts and methods for single assessment aspects, i.e. effectiveness, ethical, socio-cultural, economic, and legal issues; Logic models were used to conceptualize the intervention in its context; Feedback from stakeholder advisory panels in seven different European countries to ensure public and patient involvement; and Application in a case study on palliative care. The applicability and relevance of the draft guidances were reviewed by an external panel of 31 experts, representing 14 nationalities and a variety of professional backgrounds. Results: INTEGRATE-HTA resulted in six guidances: “Assessing effectiveness, economic, ethical, socio-cultural and legal aspects in complex health technologies”; “Guidance on moderators, predictors and patient preferences for treatment outcomes, and their integration”; “Assessment of context and implementation in systematic reviews and HTAs of complex interventions”; “Use of logic models in systematic reviews and HTAs of complex interventions”; “Integrated assessment of complex health technologies – The INTEGRATE-HTA model”; and a case study report: “Integrated assessment of home based palliative care with and without reinforced caregiver support: ‘A Demonstration HTA”. At the meeting, we will present the added value of the guidances to HTA-doers and users. Conclusion: The INTEGRATE-HTA guidances can help to unlock the value of health technology. It is not a matter of collecting the facts, but a matter of collecting facts that are considered relevant, plausible to stakeholders and which are amenable to scientific inquiry. The guidances therefore contribute to a transparent HTA process and a deeper understanding of complex health technologies. As already stated by Farrell et al.: “Assessment processes are embedded in different sorts of institutional settings, within which scientists, decision-makers, and advocates communicate to define relevant questions for analysis, mobilize certain kinds of experts and expertise, and interpret findings in particular ways.