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Open Access The Importance of Piloting an RCT Intervention L'importance de procéder à une étude pilote pour les essais cliniques aléatoires en matière d'intervention

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Abstract:

The pilot study provides a unique opportunity to identify and prepare for the challenges of evaluating an intervention. Ultimately, it will enhance the scientific rigour and value of the full-scale study. Although some journals publish reports of pilot studies, little attention has been given to the types of research questions and issues specific to these studies. This article focuses on the utility of a pilot randomized controlled trial (RCT) as a first step towards conducting an RCT. Three major objectives of a pilot RCT are discussed: assessing the feasibility and acceptability of the intervention, assessing the feasibility and acceptability of the design and procedures, and facilitating the determination of effect sizes for use in sample-size calculations.

French
L'étude pilote fournit une occasion unique de déterminer les difficultés que pose l'évaluation d'une intervention et de s'y préparer. Au bout du compte, cette façon de faire permettra d'améliorer la rigueur et la valeur scientifique de l'étude à grande échelle. Bien que certaines revues publient les comptes rendus d'études pilotes, on accorde très peu d'attention à ces types de questions et de thèmes de recherche qui sont propres à ces mêmes études. Le présent article porte principalement sur l'utilité de procéder à un essai clinique pilote sur un échantillon aléatoire comme première étape avant d'effectuer un essai clinique aléatoire. On y décrit les principaux objectifs d'un essai clinique pilote sur un échantillon aléatoire : à savoir, évaluer la faisabilité et l'acceptabilité de l'intervention, du plan de recherche et des méthodes ainsi que déterminer plus facilement les valeurs des effets à des fins de calculs pour la taille de l'échantillon.

Keywords: ACCEPTABILITY; FEASIBILITY; METHODS; PILOT STUDIES; RANDOMIZED CONTROLLED TRIALS

Document Type: Research Article

Publication date: June 1, 2009

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