Abstract
BACKGROUND: There are repeated and ongoing failures in shared decision-making and informed consent for innovative surgical procedures. Governments and regulatory bodies internationally recommend establishing information standards to support safe and transparent surgical innovation. The aim of this study was to develop a core information set (CIS) for surgical innovation. METHODS: This was a mixed-method study in three phases: a provisional CIS was generated from multiple data sources (interviews with patients/professionals (44), recorded consultations (34), policy documents (58), and published studies (213)) using qualitative content analysis; the CIS was refined, with input from key stakeholders (patient representatives, surgeon innovators, anaesthetists, lawyers, ethicists, medical directors, academic experts, and regulatory representatives) using a modified nominal group technique; and the CIS was finalized through public consultation. RESULTS: The final CIS comprised seven themes that included: what is 'new' about the procedure; potential conflicts of interest; reasons for the innovation (including why the innovation is believed to be appropriate for the patient); treatment alternatives; unknowns (including uncertain safety/efficacy and that the procedure may be abandoned/modified); expertise with the innovation; and governance, oversight, and accountability (including how safety will be monitored and recompense if anything goes wrong). Two themes require follow-up discussions after the procedure. CONCLUSION: A seven-theme CIS for surgical innovation was co-developed, with input from key stakeholders. International implementation of these information standards may support safe and transparent surgical innovation.