What are patients told about innovative surgical procedures? A qualitative synthesis of seven case studies in the UK

Introduction High-profile cases have prompted concerns about informed consent for surgical innovation, although little is known about current practice.

Methods As part of the Lotus study, we followed seven case studies of surgical innovation being introduced into NHS trusts in the UK. Interviews with innovators explored intentions about discussing procedures with patients. Pre-operative consultations between clinicians and eligible patients were audio-recorded. Interviews with patients explored their views of the information provided in the consultation. Data were synthesised across case studies using thematic analytical methods derived from grounded theory.

Results Interviews with clinicians demonstrated strong intentions to inform patients about the novel status of the procedure, although they acknowledged this could be challenging. Analysis of the consultations showed many patients were not informed when a procedure is innovative or given enough information about possible uncertainties or potential risks. Interviews with patients revealed that many patients appeared to believe that the procedure was more established than it was and were optimistic about potential benefits.

Conclusions Despite clinicians’ best intentions, there was evidence of contradictions between clinicians’ intentions to inform patients about the novelty of the procedure and their actual discussions with patients. Transparent communication is required.