• Anthony Delaney, Derek C Angus, Rinaldo Bellomo, Peter Cameron, D James Cooper, Simon Finfer, David A Harrison, David T Huang, John A Myburgh, Sandra L Peake, Michael C Reade, Steve A R Webb, Donald M Yealy, Resuscitation in Sepsis Evaluation (ARISE), Protocolized Care for Early Septic Shock (ProCESS) Investigators, and Protocolised Management In Sepsis (ProMISe) Investigators.
• Northern Clinical School, Faculty of Medicine, University of Sydney, Intensive Care Unit, Royal North Shore Hospital, Pacific Highway, St Leonards, NSW, 2065, Australia,
• Crit Care. 2008 Jan 1;12(2):210.

AbstractComplex interventions, such as the introduction of medical emergency teams or an early goal-directed therapy protocol, are developed from a number of components that may act both independently and inter-dependently. There is an emerging body of literature advocating the use of integrated complex interventions to optimise the treatment of critically ill patients. As with any other treatment, complex interventions should undergo careful evaluation prior to widespread introduction into clinical practice. During the development of an international collaboration of researchers investigating protocol-based approaches to the resuscitation of patients with severe sepsis, we examined the specific issues related to the evaluation of complex interventions. This review outlines some of these issues. The issues specific to trials of complex interventions that require particular attention include determining an appropriate study population and defining current treatments and outcomes in that population, defining the study intervention and the treatment to be used in the control group, and deploying the intervention in a standardised manner. The context in which the research takes place, including existing staffing levels and existing protocols and procedures, is crucial. We also discuss specific details of trial execution, in particular randomization, blinded outcome adjudication and analysis of the results, which are key to avoiding bias in the design and interpretation of such trials. These aspects of study design impact upon the evaluation of complex interventions in critical care. Clinicians should also consider these specific issues when implementing new complex interventions into their practice.

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