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Estimating psychological treatment effects from a randomised controlled trial with both non-compliance and loss to follow-up

Biostatistics Group, School of Epidemiology & Health Sciences, University of Manchester, UK

CHRISTOPHER DOWRICK, FRCGP

Department of Primary Care, University of Liverpool, UK

JOSÉ LUIS AYUSO-MATEOS, MD

Department of Psychiatry, Hospital Universitario de la Princessa, Universidad Autónoma de Madrid, Spain

ODD STEFFEN DALGARD, DrMed

Institute of General Practice and Community Medicine, University of Oslo, Norway

HELEN PAGE, PhD

Department of Psychology, Chester College of Higher Education, UK

VILLE LEHTINEN, MD

National Research and Development Centre for Welfare and Health, Mental Health Unit, Turku, Finland

PATRICIA CASEY, MD

Mater Misericordiae Hospital, University College Dublin, UK

CLARE WILKINSON, FRCGP

Division of General Practice, University of Wales College of Medicine, Wrexham, UK

JOSÉ LUIS VÁZQUEZ-BARQUERO, FRCPsych

Unit for Research into Social Psychiatry, University Hospital ‘Marques de Valdecilla’, Santander, Spain

GREG WILKINSON, FRCPsych

Department of Psychiatry, University of Liverpool, UK

the ODIN group

Correspondence: Graham Dunn, Biostatistics Group, School of Epidemiology & Health Sciences, University of Manchester, Stopford Building, Oxford Road, Manchester M13 9PT, UK. E-mail: g.dunn{at}man.ac.uk

Declaration of interest None. Funding detailed in Acknowledgements. Paper accepted when G.W. was Editor of the Journal.

Background The Outcomes of Depression International Network (ODIN) trial evaluated the effect of two psychological interventions for the treatment of depression in primary care. Only about half of the patients in the treatment arm complied with the offer of treatment, prompting the question:‘what was the effect of treatment in those patients who actually received it?’

Aims To illustrate the estimation of the effect of receipt of treatment in a randomised controlled trial subject to non-compliance and loss to follow-up.

Method We estimated the complier average causal effect (CACE) of treatment.

Results In the ODIN trial the effect of receipt of psychological intervention (an average of about 4 points on the Beck Depression Inventory) is about twice that of offering it.

Conclusions The statistical analysis of the results of a clinical trial subjectto non-compliance to allocated treatment is now reasonably straightforward through estimation of a CACE and investigators should be encouraged to present the results of analyses of this type as a routine component of a trial report.

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BJP 2003 183: 273-a15. [Full Text]  

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