Introduction There are significant challenges in achieving high-quality shared decision making (SDM) and informed consent for surgical innovation. Evidence shows that patients’ information needs are insufficiently addressed. We co-developed a core information set (CIS) to provide baseline information for consultation discussions between clinicians and patients offered novel surgical procedures/devices.

Methods This study adhered to guidance for CIS and core outcome set development (COS-STAD) to (i) generate a provisional CIS from data sources (44 stakeholder interviews, 34 consultations, 213 studies, 58 policies) applying thematic content analysis, (ii) refine/agree CIS with stakeholders (patients, surgeons, anaesthetists, lawyers, ethicists, medical directors, SDM experts, regulators) using nominal group technique, (iii) conduct UK public consultation, (iv) implement the CIS nationally.

Results A provisional CIS contained 8 themes/28 subthemes. Some 25 stakeholders refined/agreed a final 7-theme CIS covering what is ‘new’ about the procedure, conflicts of interest, reasons for the innovation, treatment alternatives, unknowns, surgeons’ expertise, and governance. Public consultation (N=136) endorsed all themes. Industry collaboration will implement the CIS in digital consent platforms across 38 institutions.

Conclusions An evidence-based CIS has been co-developed with key stakeholders and is the recommended standard to optimise SDM and informed consent for surgical innovation.

Acknowledgements This study was partly supported by an NIHR Clinician Scientists awarded to AM (CS-2017-17-010) and by the National Institute for Health and Care Research (NIHR) Biomedical Research Centre (BRC) at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol (BRC-1215-20011, NIHR203315). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.