World Journal of Surgery

, Volume 23, Issue 8, pp 768–780

Second Step: Testing—Outcome Measurements

  • Wilfried Lorenz
  • Hans Troidl
  • Joseph S. Solomkin
  • Christoph Nies
  • Helmut Sitter
  • Michael Koller
  • Walter Krack
  • Michael F. Roizen
Article

DOI: 10.1007/s002689900578

Cite this article as:
Lorenz, W., Troidl, H., Solomkin, J. et al. World J. Surg. (1999) 23: 768. doi:10.1007/s002689900578

Abstract

Despite worldwide enthusiasm for endoscopic surgery, this new technology is now on the top of McKinlay's “product life circle curve.” Critical questions are being asked about its benefits and burdens, but the concepts applied and the methodologies used for technology assessment are in a similar position as endoscopic surgery and need a critical evaluation. (1) There are incorrect and outdated concepts for the scientific basis of surgery (surgical theory) including the basic sciences involved; biomedicine still dominates, but assessment of outcome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 (2) Based on an outdated scientific theory for surgery, an outdated concept of disease is still propagated. It is denoted as mechanical and is based solely on biomedicine. Human subjects 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 mechanical approach. (3) Based on an outdated model of disease, the outcomes used in endoscopic surgery rely too much on traditional measures, such as mortality rate, complication rate, hospital stay, and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 for other surgical problems is outlined, such as for surgical infections and for surgical oncology. It includes an index of recovery and objective health status assessed by the doctor, a quality-of-life self-report by the patient, and the true endpoint concept as a critical weighting of both types of outcome by patients and doctors.

Copyright information

© by the Société Internationale de Chirurgie 1999

Authors and Affiliations

  • Wilfried Lorenz
    • 1
  • Hans Troidl
    • 2
  • Joseph S. Solomkin
    • 3
  • Christoph Nies
    • 4
  • Helmut Sitter
    • 1
  • Michael Koller
    • 1
  • Walter Krack
    • 1
  • Michael F. Roizen
    • 5
  1. 1.Institute of Theoretical Surgery, Philipps-University of Marburg, Baldingerstrasse, 35033 Marburg, GermanyDE
  2. 2.Second Department of Surgery, University of Cologne, Ostmerheimerstrasse 200, 51109 Köln, GermanyDE
  3. 3.Department of Surgery, University of Cincinnati, College of Medicine, Cincinnati, Ohio 45267-0558, USAUS
  4. 4.Department of General Surgery, Philipps-University of Marburg, Baldingerstrasse, 35033 Marburg, GermanyDE
  5. 5.Department of Anesthesia and Critical Care, University of Chicago, 5841 South Maryland Avenue, Chicago, Illinois 60637, USAUS