LAUSR

OBJECTIVES To investigate how information about innovative surgical procedures is communicated to patients. SUMMARY BACKGROUND DATA Despite national and international guidance that patients should be informed if a procedure is innovative and has uncertain outcomes, little is known about current practice. METHODS This qualitative study followed seven 'case studies' of surgical innovation in hospitals across the UK. Pre-operative interviews were conducted with clinician innovators (n=9), pre-operative real-time consultations between clinicians and patients were audio-recorded (n=37). Patients were interviewed post-operatively (n=30). Data were synthesised using thematic analytical methods. RESULTS Interviews with clinicians demonstrated strong intentions to inform patients about the innovative nature of the procedure in a neutral manner, although tensions between fully informing patients and not distressing them were raised. In the consultations, only a minority of clinicians actually made explicit statements about, i) the procedure being innovative, ii) their limited clinical experience with it, iii) the paucity of evidence and iv) uncertainty/unknown outcomes. Discussions about risks were generalised and often did not relate to the innovative component. Instead, all clinicians optimistically presented potential benefits and many disclosed their own positive beliefs. Post-operative patient interviews revealed that many believed that the procedure was more established than it was and were unaware of the unknown risks. CONCLUSIONS There were contradictions between clinicians' intentions to inform patients about the uncertain outcomes of innovative and their actual discussions with patients. There is a need for communication interventions and training to support clinicians to provide transparent data and shared decision-making for innovative procedures.