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.
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Prof. Dr. Edmund A.M. Neugebauer has no conflicts of interest or financial ties to disclose. Monika Becker has no conflicts of interest or financial ties to disclose. Prof. Dr. Gerhard F. Buess has no financial interest or conflict of interest in regard to this submission. Prof. Dr. Alfred Cuschieri has no financial interest or conflict of interest in regard to this submission. Dr. Hans-Peter Dauben has no conflicts of interest or financial ties to disclose. Prof. Dr. Abe Fingerhut has no conflicts of interest or financial ties to disclose. Prof. Dr. Karl H. Fuchs has no financial interest or conflict of interest in regard to this submission. Dr. Brigitte Habermalz has no conflicts of interest or financial ties to disclose in regards to submission of this paper to Surgical Endoscopy. Prof. Dr. Leonid Lantsberg has no financial interest or conflict of interest in regard to this submission. Prof. Dr. Mario Morino has no financial interest or conflict of interest in regard to this submission. Prof. Dr. Stella Reiter-Theil has no conflicts of interest or financial ties to disclose. Dr. Gabriela Soskuty is an employee of B. Braun Melsungen and has no conflict of interest or financial interest to disclose. Prof. Dr. Wolfgang Wayand has no financial interest or conflict of interest in regard to this submission. Dr. T. Welsch has no conflicts of interest or financial ties to disclose.
Monika Becker is shared first authorship with E. A. M. Neugebauer.
This study is conducted by all the authors on behalf of the EAES, and it is also conducted by Gabriela Soskuty on behalf of Eucomed.
Appraisal of evidence: formal assessment of the quality of research evidence and its relevance to the clinical question or guideline under consideration, according to predetermined criteria .
Critical appraisal: the process of assessing and interpreting evidence by systematically considering its validity, results, and relevance .
Efficacy: the extent to which a specific treatment or intervention, under ideally controlled conditions (e.g., in a laboratory), has a beneficial effect on the course or outcome of disease compared with no treatment or other routine care .
Efficiency: the extent to which the maximum possible benefit is achieved out of available resources .
Effectiveness: the extent to which a specific treatment or intervention, when used under usual or everyday conditions, has a beneficial effect on the course or outcome of disease compared with no treatment or other routine care. (Clinical trials that assess effectiveness are sometimes called management trials.) Clinical “effectiveness” is not the same as efficacy .
Ethical approval: an independent review of the scientific merit and implications of a study regarding the dignity, rights, safety, and well-being of research participants . All primary research on humans has to be first approved by a Research Ethics Committee (REC).
Evaluation: assessment of whether an intervention (for example, a treatment, service, project or program) achieves its aims. The results of evaluations can help in decision-making and in planning future policies. Process evaluation is an ongoing examination of the intervention from its conception to its delivery and includes staff performance, methods, activities, effectiveness, and efficiency. Outcome evaluation is an assessment of the immediate or midterm effects of an intervention or some aspect of an intervention .
Feasibility (technical): the process of proving that the concept is technically possible.
Health technology assessment: systematic evaluation of properties, effects, and/or impacts of health care technology. HTA may address the direct, intended consequences of technologies as well as their indirect, unintended consequences. HTA is conducted by interdisciplinary groups using explicit analytical frameworks drawing from a variety of methods .
Identifiable data: information that allows the identification of the survey respondent or data provider that it relates to its identification to be determined either directly (e.g., by name, address, reference number) or indirectly (e.g., by some distinguishing feature such as business activity, size, location) .
Research Ethics Committee (REC): committee that has the task of evaluating research proposals for approval, and also gives advice for the improvement of research protocols. In their work RECs rely on international guidelines such as the Declaration of Helsinki . Some health care institutions have Clinical Ethics Committees that may be the appropriate body for ethical advice and approval. Also, the national medical associations have Research Ethics Committees that, depending on the respective legal requirements, may have to be approached for ethical approval.
Safety: judgment of the acceptability of risk (a measure of the probability of an adverse outcome and its severity) associated with using a technology in a given situation, e.g., for a patient with a particular health problem, by a clinician with certain training, or in a specified treatment setting .
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Neugebauer, E.A.M., Becker, M., Buess, G.F. et al. EAES recommendations on methodology of innovation management in endoscopic surgery. Surg Endosc 24, 1594–1615 (2010). https://doi.org/10.1007/s00464-009-0818-3
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