Introduction The 2020 Independent Medicine and Medical Devices Safety Review raised concerns about surgical innovation. IDEAL recommends study designs based on innovation stage and whether modifications are occurring, but it is uncertain how to determine this. The LOTUS study examined how qualitative methods may inform surgeons’ decisions about early phase study design.

Methods The central LOTUS team collaborated with surgeon innovators on case studies, including uterine transplant, robot-assisted hip replacement, and autologous pericardium for aortic valve repair. Surgeon/patient interviews, consultation recordings, operative videos and surgeon meetings were used alongside standard data capture.

Results Findings from 8 case studies (8 NHS trusts, 84 surgeon/71 patient interviews, 71 consultations, 41 videos) showed how LOTUS methods provided unique additional information to that routinely captured when studying innovation. This influenced decisions about patient selection, communication, pausing cases and next-phase study design. One surgeon commented how the methods helped them ‘reflect on my own practice and communication with patients’. Data also informed development of NICE IPAC recommendations about a new procedure.

Conclusion LOTUS methods elicit ‘hidden’ views and generate previously undetected data of value to surgeons and regulators. Their further development, testing and implementation within IDEAL studies will promote safe, transparent and efficient surgical innovation.

Acknowledgements This study was funded by the National Institute for Health and Care Research Bristol Biomedical Research Centre. The views expressed are those of the author(s) and not necessarily those of the NIHR or the department of Health and Social Care.’