EAES recommendations on methodology of innovation management in endoscopic surgery.
BACKGROUND
Under the mandate of the European Association for Endoscopic Surgery (EAES) a guideline on methodology of innovation management in endoscopic surgery has been developed. The primary focus of this guideline is patient safety, efficacy, and effectiveness.


METHODS
An international expert panel was invited to develop recommendations for the assessment and introduction of surgical innovations. A consensus development conference (CDC) took place in May 2009 using the method of a nominal group process (NGP). The recommendations were presented at the annual EAES congress in Prague, Czech Republic, on June 18th, 2009 for discussion and further input. After further Delphi processes between the experts, the final recommendations were agreed upon.


RESULTS
The development and implementation of innovations in surgery are addressed in five sections: (1) definition of an innovation, (2) preclinical and (3) clinical scientific development, (4) scientific approval, and (5) implementation along with monitoring. Within the present guideline each of the sections and several steps are defined, and several recommendations based on available evidence have been agreed within each category. A comprehensive workflow of the different steps is given in an algorithm. In addition, issues of health technology assessment (HTA) serving to estimate efficiency followed by ethical directives are given.


CONCLUSIONS
Innovations into clinical practice should be introduced with the highest possible grade of safety for the patient (nil nocere: do no harm). The recommendations can contribute to the attainment of this objective without preventing future promising diagnostic and therapeutic innovations in the field of surgery and allied techniques.
Neugebauer
Edmund A M
EA
Institute for Research in Operative Medicine, Faculty of Medicine, Campus Cologne-Merheim, University of Witten/Herdecke, Ostmerheimer Str. 200, 51109, Cologne, Germany. edmund.neugebauer@uni-wh.de
Becker
Monika
M
Buess
Gerhard F
GF
Cuschieri
Alfred
A
Dauben
Hans-Peter
HP
Fingerhut
Abe
A
Fuchs
Karl H
KH
Habermalz
Brigitte
B
Lantsberg
Leonid
L
Morino
Mario
M
Reiter-Theil
Stella
S
Soskuty
Gabriela
G
Wayand
Wolfgang
W
Welsch
Thilo
T
D004059:Diffusion of Innovation; D004724:Endoscopy; D006801:Humans; D013673:Technology Assessment, Biomedical; D016896:Treatment Outcome; D057188:Workflow