Building an appraisal framework for radiotherapy innovations in a value-based context: The ESTRO-Value-based...

Area of Science:

• Oncology
• Health Services Research

Background:

• Current radiotherapy innovation appraisal lacks consistency, hindering clinical implementation and access to high-value care.
• The European Society for Radiotherapy and Oncology (ESTRO) initiated the Value-Based Radiation Oncology (VBRO) project to address this gap.

Purpose of the Study:

• To develop a categorization system for radiotherapy innovations as a foundational step towards a value-based appraisal framework.
• To support clinical implementation and regulatory decision-making for radiotherapy innovations.

Main Methods:

• A four-phase mixed-method development process integrating qualitative and quantitative data.
• Involvement of multidisciplinary stakeholders from the European radiation oncology community throughout the revision, improvement, and validation phases.

Main Results:

• Four distinct categories of radiotherapy interventions were defined: Drug-centred, Radiation-centred, Radiation-enabling, and Operational radiation interventions.
• A decision algorithm and decision tree were developed to aid in categorizing innovations based on aim, technological, and radiotherapy-specific characteristics.
• The categorization system and algorithm were validated through qualitative and quantitative methods, including bibliometrical analysis and steering committee review.

Conclusions:

• Accurate categorization of radiotherapy innovations is crucial for optimizing study design, evidence generation, and tailored appraisals.
• The developed system provides the basis for a value-based appraisal framework within the ESTRO-VBRO project to guide implementation and regulation.