Bench-to-bedside review: The evaluation of complex interventions in critical care

被引:0
|
作者
Delaney, Anthony [1 ]
Angus, Derek C. [2 ]
Bellomo, Rinaldo [3 ]
Cameron, Peter [4 ,5 ]
Cooper, D. James [6 ,7 ]
Finfer, Simon [8 ]
Harrison, David A. [9 ]
Huang, David T. [2 ]
Myburgh, John A. [10 ]
Peake, Sandra L. [11 ]
Reade, Michael C. [12 ]
Webb, Steve A. R. [13 ]
Yealy, Donald M. [14 ]
机构
[1] Univ Sydney, Royal N Shore Hosp, No Clin Sch, Fac Med,Intens Care Unit, St Leonards, NSW 2065, Australia
[2] Univ Pittsburgh, Sch Med, Dept Crit Care Med, Pittsburgh, PA USA
[3] Austin Hosp, Dept Intens Care, Heidelberg, Vic 3084, Australia
[4] Monash Univ, Dept Epidemiol & Prevent Med, Melbourne, Vic 3004, Australia
[5] Alfred Hosp, Dept Epidemiol & Prevent Med, Melbourne, Vic, Australia
[6] Monash Univ, Dept Intens Care Med, Melbourne, Vic 3004, Australia
[7] Alfred Hosp, Dept Intens Care Med, Melbourne, Vic, Australia
[8] Royal N Shore Hosp, Sydney, NSW, Australia
[9] ICNARC, London, England
[10] St George Hosp, Dept Intens Care Med, Sydney, NSW, Australia
[11] Queen Elizabeth Hosp, Dept Intens Care Med, Adelaide, SA, Australia
[12] Univ Melbourne, Austin Hosp, Melbourne, Vic, Australia
[13] Univ Western Australia, Royal Perth Hosp, Perth, WA 6009, Australia
[14] Univ Pittsburgh, Dept Emergency Med, Pittsburgh, PA USA
来源
CRITICAL CARE | 2008年 / 12卷 / 02期
关键词
D O I
10.1186/cc6849
中图分类号
R4 [临床医学];
学科分类号
1002 ; 100602 ;
摘要
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.
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页数:9
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