Measuring Value in Health Care: A Comparative Analysis of Value-based Frameworks.

Purpose: This paper presents a comparative analysis of value-based frameworks (VBFs) developed in the United States and Europe for both drugs and medical devices.

Methods: The authors relied on a comprehensive literature review to identify relevant dimensions of analysis and available VBFs. Compared to previous studies on this topic, this study focused on the roles and strategic objectives of different institutions and organizations currently orchestrating the debate and development of VBFs and value-based initiatives.

What type of clinical evidence is needed to assess medical devices?

The objective of this mini-review is to discuss the role of real-world studies as a source of clinical evidence when experimental studies, such as randomised controlled trials (RCTs), are not available. Waiting for RCT evidence when the technology is diffusing could be anti-economical, inefficient from the policy perspective and methodologically questionable.We explain how real-world studies could provide relevant evidence to decision makers.

Comparative effectiveness of Mitraclip plus medical therapy versus medical therapy alone in high-risk surgical patients: a comprehensive review.

In recent years, Mitraclip has become available as a treatment option for mitral regurgitation in high-risk surgical patients. Focusing on the incremental effectiveness of Mitraclip versus the current standard of care, this article provides a comparative review of the evidence on Mitraclip and standard medical therapy (MT) in high-risk mitral regurgitation patients. Evidence was retrieved from seven major databases.