A tool for optimising shared decision making and informed consent for surgical innovation:development and implementation of a core information set

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.<br/><br/>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.<br/><br/>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.<br/><br/>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.<br/><br/>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.