Study highlights challenges in reporting surgical innovation

A study published in the BMJ Open has revealed significant challenges in how surgical innovation is reported and evaluated using the IDEAL framework. The framework, which stands for Idea, Development, Exploration, Assessment, and Long-term study, is designed to guide the development of new surgical procedures and devices. It divides innovation into numbered stages ranging from preclinical and first in human studies to studies comparing different treatment types.

The research, led by Prof Jane Blazeby and a team at the NIHR Bristol Biomedical Research Centre, reviewed 48 papers describing studies of invasive procedures or devices and reported their study according to the IDEAL framework. This was done to understand how the IDEAL framework is applied in real-world settings.

Their findings highlight a lack of consistency and clarity in how stages of surgical innovation are described and justified. For example, terms used to describe the stages of innovation varied widely. Common terms included “innovation,” “new,” “novel,” and “first-in-human.” However, these terms often weren’t clearly defined, leading to confusion and ambiguity. Some papers described the same procedure as both new, modified and established.

According to the IDEAL framework, researchers should consult published literature to identify the appropriate stage for their intervention. However, the inconsistent and ambiguous language highlighted in this review shows that a clearer approach is needed.

In practice, study authors often chose the IDEAL stage based on either existing evidence or a lack of sufficient data on outcomes. Specifically, 36 of the articles justified their choice based on limitations in published evidence, while 32 referred to unknown feasibility and safety outcomes.

Hollie Richards, Senior Research Associate in Health Services Research at the University of Bristol and lead author of the study, said:

“This research highlights that while the IDEAL framework is a valuable tool for developing new surgical procedures, its practical application is hindered by inconsistent terminology and unclear definitions.”

Jane Blazeby, Professor of Surgery at the Bristol Medical School and study lead, said:

“Further work is needed to develop methods for better identifying and describing surgical innovations to improve the framework’s effectiveness.

“Our study is an important step towards enhancing how surgical innovations are developed and reported, ultimately aiming to improve patient care and outcomes.”