Information standards for innovative surgery: what patients need to know

Area of Science:

• Medical innovation
• Surgical procedures
• Patient safety

Background:

• Failures in shared decision-making and informed consent for innovative surgical procedures are common.
• International bodies recommend information standards for safe surgical innovation.
• A core information set (CIS) was needed to support transparency.

Purpose of the Study:

• To develop a core information set (CIS) for surgical innovation.
• To enhance shared decision-making and informed consent processes.
• To establish information standards for safe and transparent surgical innovation.

Main Methods:

• Mixed-method study across three phases.
• Provisional CIS generated from interviews, consultations, policy documents, and studies.
• CIS refined via stakeholder input and finalized through public consultation.

Main Results:

• A seven-theme CIS was developed.
• Themes include procedure novelty, conflicts of interest, rationale, alternatives, unknowns, expertise, and governance.
• Two themes require post-procedure follow-up.

Conclusions:

• A seven-theme CIS for surgical innovation was co-developed with stakeholders.
• Implementation of these information standards can promote safe and transparent surgical innovation.
• This framework supports regulatory and governmental recommendations.