Researchers develop tool for reporting modifications to innovative surgical procedures and devices
Researchers from the NIHR Biomedical Research Centre: Bristol have developed the Surgical Modification Reporting Tool (SMART) to standardise the reporting of modifications to innovative surgical procedures and devices.
SMART is a concise, seven-item checklist intended to complement the Idea, Development, Exploration, Assessment and Long-term (IDEAL) framework. The framework is a set of recommendations designed to improve how new surgical procedures and medical devices are introduced.
Researchers developed the SMART checklist to provide detailed guidance and support innovators with tracking and reporting modifications as they are developed and evaluated.
SMART aims to enhance transparency, safety, and shared learning across the surgical innovation community. It describes:
- The starting point of the innovation
- The context of the innovation
- Structured reporting of what changed, when and why
- Reflection on learning and innovation stability
The team behind SMART developed a provisional version of the checklist after conducting a systematic review of 104 IDEAL studies. This review found that changes to new surgical procedures and devices are common, but they are not reported consistently. Findings from the review were used to inform the content and structure of the provisional checklist.
Once a provisional checklist was in place, researchers refined it by interviewing 20 stakeholders, including clinicians, methodologists, industry representatives and governance professionals.
During interviews, researchers explored what stakeholders thought of the provisional checklist. They went on to optimise its content, wording, layout, scope and usability in line with stakeholder feedback.
Dr James Olivier, Honorary Senior Research Associate and lead author, said:
“The consequences of not reporting or inadequately describing modifications to innovative surgical procedures and devices can be concerning for their safe and effective evaluation.
“Failing to adequately document and share modifications could lead to promising treatments taking longer to reach patients or risk harmful modifications being repeated.
“SMART is a concise, stakeholder-informed tool to guide prospective tracking and consistent reporting of modifications to innovative invasive procedures and devices. Used alongside the IDEAL framework, it has potential to improve the quality and interpretability of surgical innovation research.”
