Framework for design and evaluation of complex interventions to improve health

doi:10.1136/bmj.321.7262.694

BMJ 2000;321:694-696 ( 16 September )

Education and debate

Framework for design and evaluation of complex interventions to improve health

Michelle Campbell, senior policy analyst ^a, Ray Fitzpatrick, professor of public health and primary care ^b, Andrew Haines, professor of primary health care ^c, Ann Louise Kinmonth, professor of general practice ^d, Peter Sandercock, professor of medical neurology ^e, David Spiegelhalter, senior scientist ^f, Peter Tyrer, professor of community psychiatry ^g.

^a Office of the President, Medical Research Council of Canada, 1600 Scott Street, Ottawa, Ontario, Canada K1 OW9, ^b Division of Public Health and Primary Health Care, Institute of Health Sciences, University of Oxford, Oxford OX3 7LF, ^c Department of Primary Care and Population Sciences, Royal Free and University College Medical School, London NW3 2PF, ^d General Practice and Primary Care Research Unit, Department of Public Health and Primary Care, Institute of Public Health, Cambridge CB2 2SR, ^e Neuroscience Trials Unit, Department of Clinical Neurosciences, Western General Hospitals NHS Trust, Edinburgh EH4 2XU, ^f MRC Biostatistics Unit, Institute of Public Health, Cambridge CB2 2SR, ^g Department of Public Mental Health, Imperial College of Science, Technology, and Medicine, St Mary's Campus, London W2 1PD

Correspondence to: R Fitzpatrick raymond.fitzpatrick@nuffield.ox.ac.uk

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

Randomised controlled trials are widely accepted as the most reliable method of determining effectiveness, but most trialshave evaluated the effects of a single intervention such as adrug. Recognition is increasing that other, non-pharmacologicalinterventions should also be rigorously evaluated.^1-3 This paperexamines the design and execution of research required to addressthe additional problems resulting from evaluation of complex interventions $---$ thatis, those "made up of various interconnecting parts."⁴ Theissues dealt with are discussed in a longer Medical Research Councilpaper (www.mrc.ac.uk/complex_packages.html). We focus on randomisedtrials but believe that this approach could be adapted to otherdesigns when they are more appropriate.

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Challenges of trials of complex interventions

There are specific difficulties in defining, developing, documenting, and reproducing complex interventions that are subjectto more variation than a drug. A typical example would be thedesign of a trial to evaluate the benefits of specialist strokeunits. Such a trial . . . [Full text of this article]

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