Complex interventions: how “out of control” can a randomised controlled trial be?

Complex interventions: how “out of control” can a randomised controlled trial be?

26 JUNE 2004 | Penelope Hawe, Alan Shiell, Therese Riley
The article discusses the challenges and potential solutions for evaluating complex interventions in community settings. Traditional approaches, which emphasize standardization and randomized controlled trials (RCTs), have been criticized for their inability to account for local context and adaptivity, leading to weak or non-significant findings. The authors propose a shift in perspective, advocating for a more nuanced understanding of complex interventions that focuses on the processes and functions rather than just the components. They suggest that interventions should be designed to facilitate specific change processes or functions, allowing for adaptation to local contexts while maintaining core objectives. This approach could enhance the effectiveness of interventions and enable meaningful evaluation through RCTs. The article also highlights the importance of re-examining the concept of "intervention integrity" to ensure that interventions remain effective across different settings. By embracing complexity science and focusing on functional rather than compositional integrity, researchers can develop more robust and adaptable interventions. The authors conclude by emphasizing the need for critical interrogation of intervention logic to build stronger and more effective interventions.The article discusses the challenges and potential solutions for evaluating complex interventions in community settings. Traditional approaches, which emphasize standardization and randomized controlled trials (RCTs), have been criticized for their inability to account for local context and adaptivity, leading to weak or non-significant findings. The authors propose a shift in perspective, advocating for a more nuanced understanding of complex interventions that focuses on the processes and functions rather than just the components. They suggest that interventions should be designed to facilitate specific change processes or functions, allowing for adaptation to local contexts while maintaining core objectives. This approach could enhance the effectiveness of interventions and enable meaningful evaluation through RCTs. The article also highlights the importance of re-examining the concept of "intervention integrity" to ensure that interventions remain effective across different settings. By embracing complexity science and focusing on functional rather than compositional integrity, researchers can develop more robust and adaptable interventions. The authors conclude by emphasizing the need for critical interrogation of intervention logic to build stronger and more effective interventions.
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