Abstract
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.
Highlights
Management of critically ill patients is complex, involving multiple interventions and processes
There is an emerging body of literature advocating the use of integrated complex interventions to optimise the treatment of critically ill patients
randomized controlled trials (RCTs), are typically used to test single interventions, such as the benefits of a drug compared to placebo and the principles underlying the testing of a more complex intervention are the same, particular theoretical and practical difficulties arise for researchers conducting trials and for clinicians attempting to critically appraise their results
Summary
Management of critically ill patients is complex, involving multiple interventions and processes. There is an emerging body of literature advocating the use of integrated complex interventions to optimise the treatment of critically ill patients Examples of these complex interventions include medical emergency teams [4], early goal directed therapy for the management of patients with severe sepsis [5], educational interventions to improve compliance with guidelines for the treatment of patients with pneumonia in the emergency department [6] or even a bundle of measures to ARISE = Australasian Resuscitation in Sepsis Evaluation; ICU = intensive care unit; ProCESS = Protocolised Care for Early Septic Shock; ProMISe = Protocolised Management in Sepsis; RCT = randomized controlled trial. RCTs, are typically used to test single interventions, such as the benefits of a drug compared to placebo and the principles underlying the testing of a more complex intervention are the same, particular theoretical and practical difficulties arise for researchers conducting trials and for clinicians attempting to critically appraise their results These difficulties include determining a representative study population, defining the intervention and deploying it in a standardised manner, and measuring appropriate outcomes. It is hoped that these insights will aid clinicians when they consider implementing complex interventions into their own practice
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
