Hostname: page-component-8448b6f56d-m8qmq Total loading time: 0 Render date: 2024-04-19T04:38:19.424Z Has data issue: false hasContentIssue false
  • English
  • Français

Pragmatic randomised controlled trials in psychiatry

Published online by Cambridge University Press:  03 January 2018

Matthew Hotopf ,
Rachel Churchill  and
Glyn Lewis
Matthew Hotopf*
Affiliation:
Guys, Kings and St Thomas' Schools of Medicine, and Institute of Psychiatry, London
Rachel Churchill
Affiliation:
Institute of Psychiatry, London
Glyn Lewis
Affiliation:
University of Wales College of Medicine, Heath Park, Cardiff
*
Dr Matthew Hotopf, Department of Psychological Medicine, Guy's, King's and St Thomas' Schools of Medicine, and Institute of Psychiatry, 103 Denmark Hill, London SE5 8AZ. Tel: 0171 740 5073; Fax: 0171 740 5129; e-mail: m.hotopf@iop.bpmf.ac.uk
Get access Rights & Permissions [Opens in a new window]

Abstract

Background

Randomised controlled trials (RCTs) are the most important method of evaluating new treatments and treatment policies. Despite this, there are relatively few large pragmatic RCTs in psychiatry.

Aims

To explore the main advantages of large pragmatic RCTs and the obstacles to performing them in psychiatry.

Method

A narrative review of literature on pragmatic RCTs with examples drawn from psychiatry and other medical specialities.

Results

Obstacles to performing pragmatic RCTs in psychiatry include the complexity of psychiatric interventions, the complexity of outcomes used in psychiatry and the difficulties of blinding subjects and investigators to some psychiatric interventions.

Conclusions

Researchers need to frame questions in a form that is relevant to clinicians and to convince clinicians to cooperate in simple large pragmatic trials.

Type
Review Article
Information
The British Journal of Psychiatry , Volume 175 , Issue 3 , September 1999 , pp. 217 - 223
Copyright
Copyright © 1999 The Royal College of Psychiatrists 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Altman, D. G. (1998) Confidence intervals for the number needed to treat. British Medical Journal, 317, 1309–1312.Google Scholar
Appleby, L., Dannehy, J. A., Thomas, C., et al (1999) Aftercare and clinical characteristics of people with mental illness who commit suicide: a case control study Lancet. 353, 1397–1400.Google Scholar
Beecham, J. & Knapp, M. (1992) Costing psychiatric interventions. In Measuring Mental Health Needs (eds Thornicroft, G., Brewin, C. R. & Wing, J.), pp. 163–183. London: Gaskell.Google Scholar
Begg, C., Cho, M., Eastwood, S., et al (1996) Improving the quality of reporting of randomized controlled trials: the CONSORT statement. Journal of the American Medical Association, 276, 637–639.Google Scholar
Black, N. (1996) Why we need observational studies to evaluate the effectiveness of health care. British Medical Journal, 312, 1215–1218.CrossRefGoogle ScholarPubMed
Brewin, C. R. & Bradley, C. (1989) Patient preferences and randomised clinical trials. British Medical Journal, 233, 313–315.Google Scholar
Coronary Drug Project Research Group (1980) Influences of adherence to treatment and response to cholesterol on mortality in the coronary drug project. New England Journal of Medicine. 303, 1038–1041.CrossRefGoogle Scholar
Dennis, M., Wellwood, L., O'Rourke, , et al (1997) How reliable are simple questions in assessing outcome after stroke? Cerebrovascular Disease. 7, 19–21.CrossRefGoogle Scholar
Everitt, B. S. (1998) Analysis of longitudinal data. Beyond MANOVA. British Journal of Psychiatry 172, 7–10.CrossRefGoogle ScholarPubMed
Fletcher, A. E., Hunt, B. M. & Bulpitt, C. J. (1987) Evaluation of quality of life in clinical trials of cardiovascular disease. Journal of Chronic Disease, 40, 557–566.CrossRefGoogle ScholarPubMed
Gotzsche, P. C. (1989) Methodology and overt and hidden bias in 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis. Controlled Clinical Trials, 10, 31–56.Google Scholar
Gray, A. M., Marshall, H., Lockwood, A., et al (1997) Problems in conducting economic evaluations alongside clinical trials. Lessons from a study of case management for people with mental disorders. British Journal of Psychiatry 170, 47–52.CrossRefGoogle ScholarPubMed
Gunnell, D. & Frankel, S. (1994) Prevention of suicide: aspirations and evidence. British Medical Journal. 510, 1227–1233.Google Scholar
Hamilton, M. (1940) A rating scale for depression. Journal of Neurology, Neurosurgery and Psychiatry 23, 56–42.Google Scholar
Hotopf, M., Lewis, G. & Normand, C. (1996) Are SSRIs a cost-effective alternative to tricyclics? British Journal of Psychiatry 168, 404–409.CrossRefGoogle ScholarPubMed
Hotopf, M., Hardy, R. & Lewis, G. (1997a) Discontinuation rates of SSRIs and tricyclic antidepressants: a meta-analysis and investigation of heterogeneity. British Journal of Psychiatry 170, 120–127.Google Scholar
Hotopf, M., Lewis, G. & Normand, C. (1997b) Putting trials on trial: the costs and consequences of small trials in depression: a systematic review of methodology. Journal of Epidemiology and Community Health, 51, 354–358.Google Scholar
Isacsson, G., Holmgren, P., Wasserman, D., et al (1994) Use of antidepressants among people committing suicide in Sweden. British Medical Journal. 308, 506–509.CrossRefGoogle ScholarPubMed
Johnson, T. (1992) Statistical methods and clinical trials. In Research Methods in Psychiatry: A Beginner's Guide (2nd edn) (eds Freeman, C. & Tyrer, P.). pp. 24–61. London: Gaskell.Google Scholar
Kerry, S. M. & Bland, J. M. (1998) The intracluster correlation coefficient in cluster randomisation. British Medical Journal, 316, 1455.Google Scholar
Licht, R. W., Gouliaev, G., Vestergaard, P., et al (1997) Generalisability of results from randomised drug trials. A trial on antimanic treatment. British Journal of Psychiatry, 170, 264–267.CrossRefGoogle ScholarPubMed
Mulward, S. & Getzsche, P. C. (1996) Sample size of randomized double-blind trials 1976–1991. Danish Medical Bulletin, 43, 96–98.Google Scholar
Pocock, S. J., Hughes, M. D. & Lee, R. J. (1987) Statistical problems in the reporting of clinical trials. A survey of three medical journals. New England Journal of Medicine. 317, 426–432.CrossRefGoogle ScholarPubMed
Rogers, S. L., Friedhoff, L. T. & The Donepezil Study Group (1996) The efficacy and safety of donepezil in patients with Alzheimer's Disease: results from a US multicentre, randomized, double blind, placebo-controlled trial. Dementia. 7, 293–303.Google Scholar
Sackett, D. L., Haynes, R. B., Tugwell, P., et al (1991) Clinical Epidemiology: A Bask Science for Clinical Medicine (2nd edn). Boston. MA: Little Brown.Google Scholar
Sackett, D. L. & Cook, R. J. (1995) The number needed to treat: a clinically useful measure of treatment effect. British Medical Journal. 310, 452–454.Google Scholar
Schwartz, D. & Lellouch, J. (1967) Explanatory and pragmatic attitudes in therapeutic trials. Journal of Chronic Disease, 20, 637–648.Google Scholar
Senn, S. (1997) Statistical Issues in Drug Development. Chichester: Wiley.Google Scholar
Simon, G. E., Von Korff, M., Heillgenstein, J. H., et al (1996) Initial antidepressant choice in primary care. Journal of the American Medical Association, 275, 1897–1902.Google Scholar
Stevens, L., Kinmonth, A. K., Peveler, R. C. et al (1997) The Hampshire Depression Project: development and piloting of clinical practice guidelines and education about depression in primary health care. Medical Education. 31, 375–379.Google Scholar
Smith, G. R., Monson, R. A. & Ray, D. C. (1986) Psychiatric consultation in somatization disorder: a randomized controled trial. New England Journal of Medicine. 314, 1407–1413.Google Scholar
Thompson, D., Hytan, T. R., Mc Mullen, W., et al (1998) Predictors of a medical-offset effect among patients receiving antidepressant therapy. American Journal of Psychiatry 155, 824–827.Google Scholar
Thornicroft, G., Gooch, C. & Deyson, D. (1992) The TAPS project. 17: Readmission to hospital for long term psychiatric patients after discharge to the community. British Medical Journal, 305, 996–998.Google Scholar
Woods, S. W. & Rizzo, J. A. (1997) Cost-effectiveness of antidepressant treatment reassessed. British Journal of Psychiatry 170, 257–263.Google Scholar
Submit a response

eLetters

No eLetters have been published for this article.