[Problem-based evidence: non-conventional methods of clinical investigations in surgery].
In the era of evidence-based medicine the application of randomised controlled trials (RCT) are crucial for innovations. In contrast with pharmacological studies surgical innovations have several difficulties: setting up a control group is not always simple, placebo is not easy to define and ethico-legal regulation of sham-operations is not well established yet. Risks of the learning curve, which are variable in time and space are quite characteristic for surgical innovations. There is a need therefore to develop new methodologies to overcome these difficulties and resulting in a widely acceptable outcome. The method of problem-based evidence (PBE) obtains the evidences from particular problems of health care using knowledge and experience; and hereby providing advantage for surgical innovations compared to RCT's. PBE provides more opportunity for organizing surgical research and their international acceptance.
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Akos
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Semmelweis Egyetem, Altalános Orvostudományi Kar I. sz. Sebészeti Klinika, Budapest. szucs.akos@gmail.com
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D018849:Controlled Clinical Trials as Topic / Q000379:methods / Q000592:standards; D019317:Evidence-Based Medicine; D013502:General Surgery / Q000191:economics / Q000193:education / Q000941:ethics; D006801:Humans; D007858:Learning; D015201:Meta-Analysis as Topic; D011340:Problem Solving; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D012042:Registries