Bench-to-bedside review: The evaluation of complex interventions in critical care
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* Corresponding author: Anthony Delaney adelaney@med.usyd.edu.au
1 Northern Clinical School, Faculty of Medicine, University of Sydney, Intensive Care Unit, Royal North Shore Hospital, Pacific Highway, St Leonards, NSW, 2065, Australia
2 Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA
3 Department of Intensive Care, Austin Hospital, Heidelberg, Victoria, Australia
4 Department of Epidemiology and Preventive Medicine, Monash University and Alfred Hospital, Melbourne, Australia
5 Department of Intensive Care Medicine, Monash University and Alfred Hospital, Melbourne, Australia
6 Royal North Shore Hospital of Sydney, Sydney, Australia
7 ICNARC, Tavistock House, Tavistock Square, London, UK
8 Department of Intensive Care Medicine, The St George Hospital, Sydney, New South Wales, Australia
9 Department of Intensive Care Medicine, Queen Elizabeth Hospital, Adelaide, SA, Australia
10 Austin Hospital, University of Melbourne, Melbourne, Victoria, Australia
11 Royal Perth Hospital, University of Western Australia, Perth, Western Australia
12 Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USA
Critical Care 2008, 12:210 doi:10.1186/cc6849
Published: 14 April 2008Abstract
Complex 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.