EAES recommendations on methodology of innovation management in endoscopic surgery

• DOI: 10.1007/s00464-009-0818-3
• Publication Date: 2010-01-06T16:28:14Z
• Authors: Edmund A. M. Neug...; Monika Becker; Gerhard F. Buess; Alfred Cuschieri; Hans-Peter Dauben; Abe Fingerhut; Karl H. Fuchs; Brigitte Habermalz; Leonid Lantsberg; Mario Morino; Stella Reiter-Theil; Gabriela Soskuty; Wolfgang Wayand; Thilo Welsch
• Keywords: Technology Assessment, Biomedical; RANDOMIZED CONTROLLED-TRIALS; REGULATIONS; 610; Guideline; DOCTORS; SURGICAL INNOVATION; Workflow; 03 medical and health sciences; 0302 clinical medicine; Humans; LAPAROSCOPIC CHOLECYSTECTOMY; KNOWLEDGE; Innovation; 9. Industry and infrastructure; Endoscopy; 3. Good health; Treatment Outcome; HEALTH-CARE; Surgery; Health technology; Diffusion of Innovation; RELIABILITY ASSESSMENT OCHRA; CLINICAL-TRIALS; ETHICS

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.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.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.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.