Content area
Full Text
Theme Submissions
This study was written within the research project INTEGRATE-HTA, co-funded by the European Commission under the 7th Framework Programme under grant agreement no. 306141. We thank members of the project team contributing to the development of the guidance: Ralph van Hoorn, Wietske Kievit, Eva Rehfuess, Hazel Squires, Louise Brereton, Wija Oortwijn, Pietro Refolo, Dario Sacchini, Gert Jan van der Wilt, Lisa Pfadenhauer, Stephanie Polus, Ansgar Gerhardus, and Benedikt Buchner.
Although there is no univocal agreement on what defines a complex health intervention, most definitions share some common features. Aspect of complex interventions often highlighted includes flexibility, nonstandardization (the form depend on the context), multiple interacting components, and nonlinear causal pathways (1). Health technology assessment (HTA) of complex health interventions, such as disease management programs, lifestyle interventions, and digital health interventions, may be challenging due to, for example, heterogeneous study designs and outcome reporting (1-3). The European Union (EU)-funded project INTEGRATE-HTA offers guidance addressing specific challenges of complexity in a series of methodological documents (4-8) integrated within the overarching INTEGRATE-HTA Model (9). This study presents key messages from the Guidance for Assessing Effectiveness, Economic Aspects, Ethical Aspects, Socio-cultural Aspects and Legal Aspects in Complex Technologies (4).
The INTEGRATE-HTA Model (9) enables a coordinated assessment of these assessment aspects along with context and implementation issues (6) and patient characteristics (5). A logic model (7) provides a structured overview of the factors and aspects surrounding the technology and visualizes the assessment results. The understanding of integrated HTA that underpins INTEGRATE-HTA does not only include considering multiple assessment aspects individually, but also how these aspects are related, and how these interrelationships affect the assessment process and outcome.
INTEGRATE-HTA identifies five key aspects of complexity relevant to HTA; multiple and changing perspectives, indeterminate phenomena, uncertain causality, unpredictable outcomes and historicity, time and path dependency/ethical complexity (10). These characteristics can be illustrated by the example of home based palliative care, where the interaction between the many different stakeholders entail multiple and changing perspectives, the range of models and different target populations means that the technology cannot be strictly defined, the individualized care and flexibility of services entail uncertain causal pathways between intervention and outcome, and the outcomes themselves may be unexpected due to many uncertainties involved (11). As all...