The importance of evidence-based surgery, surgical protocols and research methodologies

Abstract

The objective of clinical research is to establish ethically and methodologically sound evidence that can aid clinical decision-making, inform ongoing research and add to the existing body of knowledge. Surgical clinical research can encompass a wide spectrum of activities, from the assessment of technical innova-tions, determining the efficacy of pharmaceuticals and medical devices, evaluating preventative interventions or validating diagnostic and prognostic tools; the list is not exhaustive. Due to its interventional nature, clinical research in surgery can be an exceptionally complex endeavour to undertake. Investigators may encounter challenges that are less problematic in other forms of biomedical research. Blinding is a very obvious example:researchinganoperativeinterventioncouldpotentially unblind the subject and double blinding is impossible to achieve, as the investigator needs perform the procedure.The prospect of placebo surgery, although there are notable studies that employ this technique, also opens up some very serious ethical considerations. Is ‘doing harm’ for the sake of a study acceptable? Is this any less ethical than omitting a treatment where one exists? Furthermore, standardizing an operative approach may be difficult to achieve amongst different operators let alone between multiple centres. Indeed, the expertise that are present during particular periods of time or located in certain centres may drastically alter any outcome that may be investigated. These challenges can only be tackled if investigators thoroughly consider the ethical, scientific and methodological aspects oftheir proposed study.The studyprotocol istheintegral document that defines the research question and outlines its objectives and outcome measures. The protocol should include but not be limited to the following: the justification for the research, the characteristics of the population that is to be studied, details on data management and analysis, assessment of the independent and confounding variables as well as the ethical considerations and quality assurance methodology. This document can be used to evaluate and regulate the