TY - JOUR
T1 - EAES recommendations on methodology of innovation management in endoscopic surgery
AU - Neugebauer, Edmund A.M.
AU - Becker, Monika
AU - Buess, Gerhard F.
AU - Cuschieri, Alfred
AU - Dauben, Hans Peter
AU - Fingerhut, Abe
AU - Fuchs, Karl H.
AU - Habermalz, Brigitte
AU - Lantsberg, Leonid
AU - Morino, Mario
AU - Reiter-Theil, Stella
AU - Soskuty, Gabriela
AU - Wayand, Wolfgang
AU - Welsch, Thilo
PY - 2010/1/1
Y1 - 2010/1/1
N2 - 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 May2009 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 cancontribute to the attainment of this objective without preventing future promising diagnostic and therapeutic innovations in the field of surgery and allied techniques.
AB - 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 May2009 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 cancontribute to the attainment of this objective without preventing future promising diagnostic and therapeutic innovations in the field of surgery and allied techniques.
KW - Guideline
KW - Health technology
KW - Innovation
KW - Surgery
UR - http://www.scopus.com/inward/record.url?scp=77955661726&partnerID=8YFLogxK
U2 - 10.1007/s00464-009-0818-3
DO - 10.1007/s00464-009-0818-3
M3 - Article
C2 - 20054575
AN - SCOPUS:77955661726
SN - 0930-2794
VL - 24
SP - 1594
EP - 1615
JO - Surgical Endoscopy and Other Interventional Techniques
JF - Surgical Endoscopy and Other Interventional Techniques
IS - 7
ER -