BMJ  2004;328:1561-1563 (26 June), doi:10.1136/bmj.328.7455.1561

Education and debate

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

¹ Department of Community Health Sciences, University of Calgary, 3330 Hospital Drive NW, Calgary T2N 4N1, Alberta, Canada

Complex interventions are more than the sum of their parts, and interventions need to be better theorised to reflect this

The first 150 words of the full text of this article appear below.

Introduction

Many people think that standardisation and randomised controlled trials go hand in hand. Having an intervention look the same as possible in different places is thought to be paramount. But this may be why some community interventions have had weak effects. We propose a radical departure from the way large scale interventions are typically conceptualised. This could liberate interventions to be responsive to local context and potentially more effective while still allowing meaningful evaluation in controlled designs. The key lies in looking past the simple elements of a system to embrace complex system functions and processes.

Divergent views

The suitability of cluster randomised trials for evaluating interventions directed at whole communities or organisations remains vexed.¹ It need not be.² Some health promotion advocates (including the WHO European working group on health promotion evaluation) believe randomised controlled trials are inappropriate because of the perceived requirement for interventions in different sites to be standardised . . . [Full text of this article]

What is a complex intervention?

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Standardising complex interventions

Defining integrity of interventions

Real world contexts

Conclusion

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Rapid Responses:

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Evaluation of complex interventions

Lucia Dambruoso, et al.
bmj.com, 22 Jul 2004 [Full text]

Complex interventions: more thought needed

Michael J Campbell
bmj.com, 27 Oct 2004 [Full text]

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