SMART (Surgical ModificAtion Reporting Tool)

SMART is a concise, seven-item checklist to guide prospective tracking and consistent reporting of modifications to innovative invasive procedures and devices. It is designed to be used alongside the IDEAL framework to assist clinical investigators and researchers to help improve the quality and interpretability of surgical innovation research.

The checklist supports structured reporting of innovative procedures/devices in early-phase studies of their development and introduction into clinical practice, including the innovation starting point, a description of what changed, when and why, and reflection on learning and procedure/device stability.

How was the checklist developed?

The checklist is a stakeholder-informed tool. It was developed using:

  1. A systematic review of published surgical studies to characterise modification reporting practice and generate the checklist content.
  2. Interviews with multiple stakeholders including clinicians, methodologists, industry representatives and governance professionals to explore views, refine and optimise the checklist's content, wording, layout, scope and usability.

The checklist is intended to be used as a pre-publication tool.  

Funding

This study was supported by the National Institute for Health and Care Research (NIHR) Bristol Biomedical Research Centre (BRC; grant number NIHR203315) and the Medical Research Council (MRC; grant number UK Research and Innovation 484). The views expressed are those of the author(s) and not necessarily those of the MRC, NIHR or the Department of Health and Social Care.

Governance

Ethical approval to develop the SMART checklist was granted by the University of Bristol Faculty of Health Sciences Research Ethics Committee (Reference ID: 56522).