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

Anthony Delaney, Derek C Angus, Rinaldo Bellomo, Peter Cameron, David 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

Research output: Contribution to journalArticleResearchpeer-review

32 Citations (Scopus)

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.
Original languageEnglish
Pages (from-to)1 - 9
Number of pages9
JournalCritical Care
Volume12
Issue number2 (Art. No.: 210)
DOIs
Publication statusPublished - 2008

Cite this

Delaney, Anthony ; Angus, Derek C ; Bellomo, Rinaldo ; Cameron, Peter ; Cooper, David James ; Finfer, Simon ; Harrison, David A ; Huang, David T ; Myburgh, John A ; Peake, Sandra L ; Reade, Michael C ; Webb, Steve A R ; Yealy, Donald M. / Bench-to-bedside review: the evaluation of complex interventions in critical care. In: Critical Care. 2008 ; Vol. 12, No. 2 (Art. No.: 210). pp. 1 - 9.
@article{8ea09686e9264e0caec9cd4e4e235b66,
title = "Bench-to-bedside review: the evaluation of complex interventions in critical care",
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.",
author = "Anthony Delaney and Angus, {Derek C} and Rinaldo Bellomo and Peter Cameron and Cooper, {David James} and Simon Finfer and Harrison, {David A} and Huang, {David T} and Myburgh, {John A} and Peake, {Sandra L} and Reade, {Michael C} and Webb, {Steve A R} and Yealy, {Donald M}",
year = "2008",
doi = "10.1186/cc6849",
language = "English",
volume = "12",
pages = "1 -- 9",
journal = "Critical Care",
issn = "1364-8535",
number = "2 (Art. No.: 210)",

}

Bench-to-bedside review: the evaluation of complex interventions in critical care. / Delaney, Anthony; Angus, Derek C; Bellomo, Rinaldo; Cameron, Peter; Cooper, David James; Finfer, Simon; Harrison, David A; Huang, David T; Myburgh, John A; Peake, Sandra L; Reade, Michael C; Webb, Steve A R; Yealy, Donald M.

In: Critical Care, Vol. 12, No. 2 (Art. No.: 210), 2008, p. 1 - 9.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Bench-to-bedside review: the evaluation of complex interventions in critical care

AU - Delaney, Anthony

AU - Angus, Derek C

AU - Bellomo, Rinaldo

AU - Cameron, Peter

AU - Cooper, David James

AU - Finfer, Simon

AU - Harrison, David A

AU - Huang, David T

AU - Myburgh, John A

AU - Peake, Sandra L

AU - Reade, Michael C

AU - Webb, Steve A R

AU - Yealy, Donald M

PY - 2008

Y1 - 2008

N2 - 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.

AB - 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.

UR - http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2447586/

U2 - 10.1186/cc6849

DO - 10.1186/cc6849

M3 - Article

VL - 12

SP - 1

EP - 9

JO - Critical Care

JF - Critical Care

SN - 1364-8535

IS - 2 (Art. No.: 210)

ER -