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Klinische Studien, Outcome-Parameter

Ein Paradigma-Wechsel?

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Zusammenfassung

Im Rahmen klinischer Vergleichsstudien in der Chirurgie und Orthopädie werden unterschiedliche Therapien und Therapietechniken oder verschiedene Implantate miteinander verglichen. Die in der wissenschaftlichen Literatur der letzten Jahre gefundenen klinischen Studien verwenden vornehmlich klinische Zielgrößen, wie "fracture union", "ROM" oder Infektionsrate, ferner patientenbezogene Zielgrößen, wie "Schmerz" oder "Rückkehr an den Arbeitsplatz (return to work)", zur Beurteilung des Behandlungserfolges. Bei allen betroffenen Studien wird deutlich dass der Begriff "Return to Work" nicht klar definiert ist: Weder wurde eine Angabe gefunden, wer anhand welcher Kriterien den Zeitpunkt bestimmt hat, noch wurde Teilzeitarbeit, Positionswechsel oder resultierende Umschulungen berücksichtigt.

Abstract

In the context of comparative clinical studies in surgery and in orthopedic surgery different therapies, techniques, or implants have been compared. Recent scientific publications mainly mention clinical outcome measurements such as fracture union, ROM, infection rate, as well as patient-related criteria such as pain or return to work (RTW) in order to evaluate the success of the treatment. It becomes obvious that more often than not the term "return to work" is not clearly defined. It is not mentioned who measures which criteria at which point in time, nor are part-time occupation, job change, or training on a new job part of the considerations.

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Authors and Affiliations

  1. AO Clinical Investigation and Documentation, Davos, Schweiz

    B. P. Hanson

  2. Department of Health Services—Center for Cost and Outcome Research, University of Washington, D.C., USA

    B. Kopjar

  3. AO Clinical Investigation and Documentation (AOCID), Clavadelerstrasse, 7270 , Davos Platz

    B. P. Hanson

Authors
  1. B. P. Hanson
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  2. B. Kopjar
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Correspondence to B. P. Hanson.

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Hanson, B.P., Kopjar, B. Klinische Studien, Outcome-Parameter. Chirurg 74, 1034–1039 (2003). https://doi.org/10.1007/s00104-003-0740-5

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  • DOI: https://doi.org/10.1007/s00104-003-0740-5

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