Second step: Testing - Outcome measurements

Despite worldwide enthusiasm for endoscopic surgery, this new technology is now on the top of McKinlay's "product life circle curve." Critical questio ns are being asked about its benefits and burdens, but the concepts applied and the methodologies used for technology assessment are in a similar posi tion as endoscopic surgery and need a critical evaluation. (1) There are in correct and outdated concepts for the scientific basis of surgery (surgical theory) including the basic sciences involved; biomedicine still dominates , but assessment of outcome after operations is no longer possible without clinical epidemiology and social psychology. (2) Based on an outdated scien tific theory for surgery, an outdated concept of disease is still propagate d. It is denoted as mechanical and is based solely on biomedicine. Human su bjects are reduced to biologic machines, and outcomes measurement excludes most dimensions of functioning and well-being To achieve a valid result for outcome measures, a hermeneutic approach must be combined with the mechani cal approach. (3) Based on an outdated model of disease, the outcomes used in endoscopic surgery rely too much on traditional measures, such as mortal ity rate, complication rate, hospital stay, and especially an endless list of biochemical mediators. Their alterations during the perioperative period have not yet been shown to be related to clinical or hermeneutic outcomes. A new method of assessment for clinical trials in endoscopic surgery and f or other surgical problems is outlined, such as for surgical infections and for surgical oncology. It includes an index of recovery and objective heal th status assessed by the doctor, a quality-of-life self-report by the pati ent, and the true endpoint concept as a critical weighting of both types of outcome by patients and doctors.