VALIDATE handbook
The VALIDATE handbook explains how values like ethics, equity, and social impact can be included in health technology assessments. It helps decision-makers better understand how facts and values work together when evaluating new health technologies.
At a glance
Use when
Conducting HTAs where ethical, equity, or social implications are significant; when stakeholder engagement and deliberative processes are prioritized
Avoid when
Rapid or highly resource-constrained assessments requiring only clinical or economic data
Inputs
Health technology data, stakeholder input, ethical and social context, legal and organizational frameworks
Outputs
Comprehensive HTA reports integrating empirical and normative analysis, guidance for value-sensitive decision-making
How it works
The VALIDATE handbook presents a structured approach for integrating empirical analysis and normative inquiry in Health Technology Assessment (HTA), developed within the 2018–2021 EU Erasmus+ project VALIDATE. It emphasizes the interrelated nature of clinical, economic, ethical, legal, social, and organizational aspects of health technologies and supports deliberative democratic decision-making through transparent stakeholder involvement and value-sensitive analysis.
- HTA domains
- Clinical Effectiveness, Patient and Social Aspects, Aspects Beyond HTA
- Assumptions
- Values are inherent in HTA processes and should be made explicit; integration of empirical and normative analysis improves legitimacy and transparency of decisions
- Strengths
- Promotes transparency in value-laden decisions; supports inclusive and democratic HTA processes; bridges theory and practice in value integration
- Limitations
- Requires interdisciplinary expertise; may increase complexity and resource demands in HTA processes
- Also known as
- VALIDATE Handbook, VALIDATE approach, Values In Doing Assessments of healthcare Technologies handbook
Questions this answers
- › How can ethical, social, and organizational values be systematically integrated into HTA?
- › What is the relationship between empirical evidence and normative considerations in HTA?
- › How can stakeholder perspectives be productively included throughout the HTA process?
- › How does the VALIDATE approach support equitable and transparent decision-making?
- › What are the theoretical foundations for value integration in HTA?
- › What practical and organizational changes are needed to implement value-sensitive HTA?
References & sources
Related methods
Similar by meaning
- We need to talk about values: framework for articulating normative reasoning in HTA
- IMPACT-HTA multicriteria value framework
- Evidence-Informed Deliberative Processes (EDP) framework
- Principles for Deliberative Processes in HTA
- Key Principles for the Improved Conduct of Health Technology Assessments for Resource Allocation Decisions
Beta record. Generated from the primary source via AI extraction and independent audit, pending final human review.