The VALIDATE approach is building on the insights of the (2013-2016) EU-funded project ‘Integrated health technology assessment for the evaluation of complex technologies’ (INTEGRATE-HTA), in which three VALIDATE consortium partners were also involved.

In order to be useful for decision-making, health technology assessments (HTAs) should explicitly consider the factors that make the intervention (or its context) complex and derive conclusions in a way that integrates across various outcomes. The INTEGRATE-HTA project set out to develop and apply methodological guidance on these issues. While the focus of the project was on HTA, most of the methodological guidance applies equally to systematic reviews.

The overarching product was the INTEGRATE-HTA model, a step-wise approach to conduct an integrated HTA. In a first step, stakeholder advisory panels are employed to scope the HTA. In a second step, the intervention and its implementation in context are conceptualized and structured based on a logic model and comprehensive framework patient preferences and possible modifiers of intervention effects are identified. In a third step, using a variety of methods, evidence is pulled together on effectiveness, economic, ethical, social and other aspects. In a fourth step, the evidence is inserted back into the logic model to visualize inter-relationships across all aspects and outcomes of the HTA. In a fifth step, the results are presented to facilitate decision-making. All INTEGRATE-HTA guidances are listed below and can be freely downloaded.

  1. INTEGRATE-HTA: an introduction to the guidances
  2. Guidance on the integrated assessment of complex health technologies: the INTEGRATE-HTA model
  3. Guidance for assessing effectiveness, economic aspects, ethical aspects, sociocultural aspects and legal aspects in complex technologies
  4. Guidance for the assessment of treatment moderation and patients’ preferences
  5. Guidance for the assessment of context and implementation in HTAs and systematic reviews of complex interventions: the Context and Implementation of Complex Interventions (CICI) framework
  6. Guidance on the use of logic models in HTAs of complex interventions
  7. Guidance on choosing qualitative evidence synthesis methods for use in HTAs of complex interventions
  8. Integrated assessment of home-based palliative care with and without reinforced caregiver support: ‘A demonstration of INTEGRATE-HTA methodological guidances’ – executive summary