Abstract
Background
Surgical innovation drives progress but challenges conventional models of informed consent.
Objective
To synthesize qualitative evidence on how adult patients perceive, understand, and decide about innovative surgical procedures, and to develop an evidence-informed framework for ethical, patient-centered consent.
Methods
A qualitative evidence synthesis following PRISMA 2020 guidelines was conducted for studies exploring patient perspectives or decision-making in the context of surgical innovation. Confidence in each qualitative finding was assessed using the GRADE-CERQual approach.
Results
Eight studies were included. Thematic synthesis identified recurrent patterns and meta-themes across qualitative and mixed-methods data. Ten meta-themes emerged, highlighting that patients view innovation with optimism and trust but limited comprehension of uncertainty. Multimedia and interactive consent tools improved understanding. A five-pillar framework was derived which prompted the construction of a 10 point structured informed consent proforma—clarifying novelty, disclosing uncertainty, acknowledging surgeon experience, using layered information, and supporting shared decision-making.
Conclusion
Patients’ perceptions of surgical innovation are shaped more by trust and perceived progress than by understanding of risk. Ethical, layered, and dialogue-driven consent can transform uncertainty into informed partnership.
Keywords
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References
Supplementary Material
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