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BMC Health Services Research BioMed Central BMC Health Services Research x 2002, 2 Research article Application of the development stages of a cluster randomized trial to a framework for evaluating complex health interventions Mark B Loeb Address: Departments of Pathology and Molecular Medicine and Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada E-mail: loebm@mcmaster.ca Published: 11 July 2002 Received: 13 March 2002 Accepted: 11 July 2002 BMC Health Services Research 2002, 2:13 This article is available from: /1472-6963/2/13 © 2002 Loeb; licensee BioMed Central Ltd. Verbatim copying and redistribution of this article are permitted in any medium for any purpose, provided this notice is preserved along with the articles original URL. Abstract Introduction: Trials of complex health interventions often pose difficult methodologic challenges. The objective of this paper is to assess the extent to which the various development steps of a cluster randomized trial to optimize antibiotic use in nursing homes are represented in a recently published framework for the design and evaluation of complex health interventions. In so doing, the utility of the framework for health services researchers is evaluated. Methods: Using the five phases of the framework (theoretical, identification of components of the intervention, definition of trial and intervention design, methodological issues for main trial, promoting effective implementation), corresponding stages