Evaluation and stages of surgical innovations.
Barkun JS., Aronson JK., Feldman LS., Maddern GJ., Strasberg SM., Balliol Collaboration None., Altman DG., Barkun JS., Blazeby JM., Boutron IC., Campbell WB., Clavien P-A., Cook JA., Ergina PL., Flum DR., Glasziou P., Marshall JC., McCulloch P., Nicholl J., Reeves BC., Seiler CM., Meakins JL., Ashby D., Black N., Bunker J., Burton M., Campbell M., Chalkidou K., Chalmers I., de Leval M., Deeks J., Grant A., Gray M., Greenhalgh R., Jenicek M., Kehoe S., Lilford R., Littlejohns P., Loke Y., Madhock R., McPherson K., Rothwell P., Summerskill B., Taggart D., Tekkis P., Thompson M., Treasure T., Trohler U., Vandenbroucke J.
Surgical innovation is an important part of surgical practice. Its assessment is complex because of idiosyncrasies related to surgical practice, but necessary so that introduction and adoption of surgical innovations can derive from evidence-based principles rather than trial and error. A regulatory framework is also desirable to protect patients against the potential harms of any novel procedure. In this first of three Series papers on surgical innovation and evaluation, we propose a five-stage paradigm to describe the development of innovative surgical procedures.