Summary
The organizational and statistical concept of the cooperative randomized controlled clinical trial on gnotobiotic care and its effect in acute leukamia patients is described. The purpose is the clarification of the concept of the study and the comparison with other studies on the same subject. It is concluded that the value of the results and of the decisions based on them depend mainly on the statistical design, the protocol, and the performance of a study. The performance of a controlled study depends on its organizational details, its monitoring, documentation, and appropriate biometric evaluation. In this particular study it proved fruitful that a statistician was engaded in the evaluation and also in developing the protocol and in carrying out the study.
Zusammenfassung
Die organisatorischen und statistischen Maßnahmen einer kooperativen, randomisierten und kontrollierten klinischen Therapiestudie zur gnotobiotischen Behandlung von Patienten mit akuter Leukämie werden beschrieben. Der Zweck der Publikation ist die Verdeutlichung der Konzeption der Studie und der Vergleich mit der Konzeption anderer Studien zur gleichen Sachfrage. Es wird herausgestellt, daß die Bedeutung der Ergebnisse und die Richtigkeit der daraus resultierenden Entscheidungen sehr stark vom statistischen Versuchsplan, dem Versuchsprotokoll und der Ausführung der Studie abhängen. Die Ausführung einer kontrollierten Studie wiederum hängt ab von den organisatorischen Einzelheiten, dem Grad ihrer Überwachung, von der Art und dem Umfang der Dokumentation und schließlich von einer adäquaten biometrischen Auswertung. Für diese Studie erwies es sich als fruchtbar, daß ein Statistiker nicht nur an der Auswertung mitwirkte, sondern auch an der Entwicklung des Protokolls und an der Durchführung der Studie beteiligt war.
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This work was supported by the following institutions: Landesamt für Forschung des Landes Nordrhein-Westfalen, Dutch Ministry of Public Health, Deutsche Forschungsgemeinschaft im SFB 112 “Zellsystemphysiologie”.
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European Organization for Research on Treatment of Cancer Gnotobiotic Project Group Writing Committee., Gaus, W., Wendt, F. et al. Protective isolation and antimicrobial decontamination in patients with high susceptibility to infection. Infection 5, 248–254 (1977). https://doi.org/10.1007/BF01640790
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DOI: https://doi.org/10.1007/BF01640790