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.
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.
Authors: Jeffrey S Barkun; Jeffrey K Aronson; Liane S Feldman; Guy J Maddern; Steven M Strasberg; Douglas G Altman; Jeffrey S Barkun; Jane M Blazeby; Isabell C Boutron; W Bruce Campbell; Pierre-Alain Clavien; Jonathan A Cook; Patrick L Ergina; David R Flum; Paul Glasziou; John C Marshall; Peter McCulloch; Jon Nicholl; Bournaby C Reeves; Christoph M Seiler; Jonathan L Meakins; Deborah Ashby; Nick Black; John Bunker; Martin Burton; Marion Campbell; Kalipso Chalkidou; Iain Chalmers; Marc de Leval; Jon Deeks; Adrian Grant; Muir Gray; Roger Greenhalgh; Milos Jenicek; Sean Kehoe; Richard Lilford; Peter Littlejohns; Yoon Loke; Rajan Madhock; Kim McPherson; Peter Rothwell; Bill Summerskill; David Taggart; Parris Tekkis; Matthew Thompson; Tom Treasure; Ulrich Trohler; Jan Vandenbroucke Journal: Lancet Date: 2009-09-26 Impact factor: 79.321
Authors: Joanne Lynn; Mary Ann Baily; Melissa Bottrell; Bruce Jennings; Robert J Levine; Frank Davidoff; David Casarett; Janet Corrigan; Ellen Fox; Matthew K Wynia; George J Agich; Margaret O'Kane; Theodore Speroff; Paul Schyve; Paul Batalden; Sean Tunis; Nancy Berlinger; Linda Cronenwett; J Michael Fitzmaurice; Nancy Neveloff Dubler; Brent James Journal: Ann Intern Med Date: 2007-04-16 Impact factor: 25.391
Authors: Hemanga K Bhattacharjee; Gerhard F Buess; Francisco Cesar Becerra Garcia; Pirmin Storz; Mousumi Sharma; Sidonia Susanu; Andreas Kirschniak; Mahesh C Misra Journal: Surg Endosc Date: 2010-12-07 Impact factor: 4.584
Authors: K H Fuchs; A Meining; D von Renteln; G Fernandez-Esparrach; W Breithaupt; C Zornig; A Lacy Journal: Surg Endosc Date: 2013-03-30 Impact factor: 4.584
Authors: R Siegel; M A Cuesta; E Targarona; F G Bader; M Morino; R Corcelles; A M Lacy; L Påhlman; E Haglind; K Bujko; H P Bruch; M M Heiss; M Eikermann; E A M Neugebauer Journal: Surg Endosc Date: 2011-06-24 Impact factor: 4.584