“Laurent Lantieri and colleagues report the prospective results of a programme of facial allotransplantation including long-term follow-up of seven transplanted patients (IDEAL Stage 2a) and they ask readers “should we continue?”. As J Rodrigo Diaz-Siso and Eduardo D Rodriguez discuss in their accompanying Comment, the promising outcomes reported in this small case series mean that the focus should now shift to outcome reporting and comparison with the standard(s) of care. This transition would be described as a move from the development and exploration stages to the assessment stage of evaluation by Peter McCulloch and the Balliol Collaboration in the Idea Development Exploration Assessment Long-term study (IDEAL) recommendations for surgical innovation.”
“ A workshop on the future of surgery held at the UK Royal College of Surgeons, London on Sept 20, explored the reasons why the transition from development (2a) and exploration (2b) to assessment (3) of surgical innovations now required by the technique of facial allotransplantation so often proves difficult. The personal and professional investment of individual surgeons in innovations seems to play a key part. In comparison to drug company research, individual surgeons play a greater part in the evaluation of techniques or devices, effectively functioning as gatekeepers for innovation. Recruiting patients to stage 1 or 2 trials requires a familiarity with and a belief in the innovation, such that surgeons might begin to feel equipoise no longer exists, or could continue to iteratively refine the technique, sometimes unnecessarily.”
“Failure to make a timely transition to innovation assessment has many implications: an ethical failure of responsibility to trial participants, a high likelihood of research waste, the risk that a superior technique is ignored, and the possibility that rapid uptake of an attractive new technique—recommended by an eminent surgeon, for example—is such that a randomised comparison is no longer possible.”
“In these circumstances emphasising uncertainty rather than equipoise, which suggests the clinician has equal levels of doubt about the efficacy of the two approaches, can be a way to get even the most polarised surgeons to collaborate on a trial”, said Andrew Cook, lead on surgery and interventional procedures for the UK National Institute of Health Research Health Technology Assessment programme at the Royal College meeting.
“This theme of improving the quality of surgery is also picked up by Art Sedraykan (Vice-Chair, IDEAL Collaboration) and colleagues, who discuss the importance of surgical registries. Rigorous registries are clearly vital for the transparent, long-term study of all new innovations but Sedraykan and colleagues go further, suggesting that almost all surgical patients should be entered into registries. Major national all-inclusive registries provide high-quality feedback to surgeons on their own outcomes, and have a proven role in facilitating the improvement they suggest.”
(Emphasis and specific addition of IDEAL Stages added by IDEAL)