• Daisy Elliott, Cynthia A Ochieng, Jesmond Zahra, McNairAngus G KAGKCentre for Surgical Research, National Institute for Health Research Bristol and Weston Biomedical Research Centre, Surgical Innovation Theme, Population Health Sciences, Bristol Medical School, North Bristol NHS Trust, University of Bri, Barry G Main, Anni Skilton, Natalie S Blencowe, Sian Cousins, Sangeetha Paramasivan, Christin Hoffmann, Jenny L Donovan, Jane M Blazeby, and Lotus clinical innovator collaborators.
• Centre for Surgical Research, National Institute for Health Research Bristol and Weston Biomedical Research Centre, Surgical Innovation Theme, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.
• Ann. Surg. 2023 Sep 1; 278 (3): e482e490e482-e490.

ObjectivesTo investigate how information about innovative surgical procedures is communicated to patients.BackgroundDespite the national and international guidance that patients should be informed whether a procedure is innovative and has uncertain outcomes, little is known about current practice.MethodsThis qualitative study followed 7 "case studies" of surgical innovation in hospitals across the United Kingdom. Preoperative interviews were conducted with clinician innovators (n=9), preoperative real-time consultations between clinicians and patients were audio-recorded (n=37). Patients were interviewed postoperatively (n=30). Data were synthesized using thematic analytical methods.ResultsInterviews 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, (1) the procedure being innovative, (2) their limited clinical experience with it, (3) the paucity of evidence, and (4) uncertainty/unknown outcomes. Discussions about risks were generalized and often did not relate to the innovative component. Instead, all clinicians optimistically presented potential benefits and many disclosed their own positive beliefs. Postoperative patient interviews revealed that many believed that the procedure was more established than it was and were unaware of the unknown risks.ConclusionsThere 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.Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.

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