Understanding Patient Perspectives on Innovative Surgical Procedures: A Qualitative Evidence Synthesis and Framework for Informed Consent.

This article focuses on adult patients' perceptions, understanding, and decision-making regarding innovative surgical procedures, synthesizing qualitative evidence to develop an ethical, patient-centered informed consent framework. Analysis of eight studies from the United States and United Kingdom revealed that patients generally approach surgical innovation with optimism and trust but have limited comprehension of associated uncertainties and risks, often relying heavily on surgeon authority. The synthesis identified ten meta-themes, including misconceptions about innovation, trust dynamics, and the effectiveness of multimedia consent tools, leading to a proposed five-pillar framework emphasizing clear disclosure of novelty, uncertainty, surgeon experience, layered information delivery, and supported shared decision-making. The authors also developed a 10-point structured informed consent proforma to operationalize these pillars, aiming to enhance transparency, comprehension, and voluntariness in consent for surgical innovation. Limitations include geographic concentration in high-income countries and underrepresentation of diverse populations, highlighting the need for further validation across varied cultural and resource settings.