Studienendpunkte bei der chronisch-obstruktiven Lungenerkrankung (COPD): „Minimal Clinically Important Difference”[1]

Zusammenfassung

Ab welcher Veränderung bzw. ab welchem Schwellenwert bei klinischen für die COPD als bedeutungsvoll angesehenen Erfolgsparametern eine für den Patienten spürbare Verbesserung anzunehmen ist, kann in Ermangelung validierter Studienergebnisse häufig nur geschätzt werden. Mit der Festlegung des minimal für den Patienten bedeutsamen Unterschieds (minimal clinically important difference = MCID) wird versucht, die klinische Relevanz der in Studien beobachtbaren Verbesserungen einzelner Parameter festzulegen. Der MCID-Wert ist somit ein für den Patienten spürbarer Schwellenwert, der für jeden einzelnen Parameter separat festgelegt werden muss. Diese Übersicht schlägt für die in der Behandlung der COPD häufig verwendeten Erfolgsparameter MCID-Werte vor und diskutiert die damit verbundenen methodischen Schwierigkeiten.

Abstract

The concept of the minimal clinically important difference (MCID) is intended to provide a measure of relevance for a statistically applied in patients with COPD. Clinically important differences are those differences relevant to the individual patient and important to the patient's life. However, people's difference in a diagnostic parameter perception of what is important vary. Furthermore, physicians may rate the significance of a particular marker and its difference which can be achieved by a pharmacological intervention differently from the patient. Thus, the major problem with defining an MCID for any measure is that the most important differences, which require the most subtle measures for an individual patient, are likely to have the least general application. Conversely, measures that can be generalised are unlikely to have much individual importance and will be very crude tools for an individual assessment. In medical trials both, statistical rigor and clinical relevance are generally required, and MCID is without doubt a key application tool defining treatment success or treatment failure. This paper gives an update on the concept of a minimal important difference of most relevant parameters in COPD treatment.

1 Mit Unterstützung durch Astra Zeneca GmbH

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