Towards the Implementation of a Value Framework for Diagnostic Technologies: Operationalization, Piloting and Validation in Latin America.

In 2020, a group of 30 stakeholders from Latin America established fifteen criteria for a value framework (D-VF) to assess and make decisions on diagnostic technologies. This paper aims to present the operationalization, piloting, and initial validation of the framework for its implementation. This work was carried out collaboratively with a variety of stakeholders. Three sequential phases were undertaken: (1) operationalization of the D-VF through a literature search for conceptual definitions and assessment tools; (2) piloting of the D-VF through a rapid health technology assessment (HTA) document applying the methodology of the framework; and, (3) a face validation process conducted through a virtual workshop. Usefulness and implementation of the framework opinions were collected. The operationalization of the framework was conducted, and a methodological user guide was published. The D-VF criteria were applied in an HTA document on HPV testing in cervical cancer screening. Also, an open-access training program was developed. Stakeholders agreed on the usefulness of the D-VF for assessment and decision-making stages of diagnostic technologies. However, they highlighted the need to improve technical capacities and the potential for added complexity when applying a D-VF with many criteria. The absence of an established value framework for diagnostic technologies in LA and the potential for strengthening technical capacities made the project valuable to those involved. The framework was shown to be fit for implementation in real-life decision-making settings after the operationalization, piloting, and initial validation phases. Further experiences are needed to support its implementation.

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