Hostname: page-component-586b7cd67f-tf8b9 Total loading time: 0 Render date: 2024-11-28T14:17:30.778Z Has data issue: false hasContentIssue false

Pragmatic Versus Explanatory Trials

Published online by Cambridge University Press:  10 March 2009

Kenneth D. MacRae
Affiliation:
Charing Cross and Westminster Medical School

Extract

This article considers the distinction between “explanatory” and “pragmatic” aims in clinical trials—the distinction between testing a biological hypothesis and providing evidence to permit a choice between alternative treatment policies. The choice of treatments to compare, the selection of patients for the trial, the study size, and how the treatment comparison should be made are among the matters discussed. In general, where explanatory and pragmatic aims conflict, the pragmatic aim will often take priority.

Type
Special Section: Technology Assessment and Surgical Policy
Copyright
Copyright © Cambridge University Press 1989

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

REFERENCES

Atkins, H., Hayward, J. L., Klugman, D. J., & Wayte, A. B.Treatment of breast cancer: A report after ten years of a clinical trial. British Medical Journal, 1972, 2, 423–29.CrossRefGoogle ScholarPubMed
Brinkley, D., & Haybittle, J. L.Treatment of stage-Il carcinoma of the female breast. Lancet, 1966, 2, 291–95.CrossRefGoogle Scholar
Bruce, J.Operable cancer of the breast: A controlled clinical trial. Cancer, 1971, 28, 1443–52.3.0.CO;2-T>CrossRefGoogle ScholarPubMed
Cancer Research Campaign Working Party. Cancer Research Campaign (King's/Cambridge) trial for early breast cancer: A detailed update at the tenth year. Lancet, 1980, 2, 5560.Google Scholar
Easson, E. C. Post-operative radiotherapy in breast cancer. In Forrest, A. P. M. & Kunkler, P. B. (Eds.). Prognostic factors in breast cancer. Edinburgh: Livingstone, 1968, 118–27.Google Scholar
Fields, W. S., Maslenikov, V., Meyer, J. S., Hass, W. K., Remington, R. D., & Macdonald, M.Joint study of extracranial arterial occlusion. Journal of the American Medical Association, 1970, 211, 19932003.CrossRefGoogle ScholarPubMed
Freiman, J. A., Chalmers, T. C., Smith, H., & Kuebler, R. R.The importance of beat, the type II error and sample size in the design and interpretation of the randomized control trial. New England Journal of Medicine, 1978, 299, 690–94.CrossRefGoogle Scholar
Healy, M. J. R.Is statistics a science? Journal of the Royal Statistics Society, 1978, 141, 385–93.CrossRefGoogle Scholar
Healy, M. J. R.Truth and consequences in medical research. Lancet, 1978, 2, 1300–01.CrossRefGoogle ScholarPubMed
Lachin, J. M.Introduction to sample size determination and power analysis for clinical trials. Controlled Clinical Trials, 1981, 2, 93113.CrossRefGoogle ScholarPubMed
Luft, H. S., Bunker, J. P., & Enthoven, A. C.Should operations be regionalized? The empirical relation between surgical volume and mortality. New England Journal of Medicine, 1979, 301, 1364–69.CrossRefGoogle ScholarPubMed
MacRae, K. D.The value of small clinical trials. Recent Results in Cancer Research, 1988, 111, 191–94.CrossRefGoogle ScholarPubMed
McPeek, B., Mosteller, F., McKneally, M.Randomized clinical trials in surgery. International Journal of Technology Assessment in Health Care, 1989, 5, 317–32.CrossRefGoogle ScholarPubMed
Powell-Tuck, J., MacRae, K. D., Healy, M. J. R., Lennard-Jones, J. E., & Parkin, R. A.A defence of the small clinical trial: Evaluation of three gastroenterological studies. British Medical Journal, 1986, 292, 599602.CrossRefGoogle ScholarPubMed
Schwartz, D., & Lellouch, R.Explanatory and pragmatic attitudes in therapeutic trials. Journal of Chronic Diseases, 1967, 20, 637–48.CrossRefGoogle Scholar
Schwartz, D., Flamant, R., & Lellouch, J.L'essai therapeutique chez l&homme. Paris: Flammarion Medecine-Sciences, 1970.Google Scholar
Schwartz, D., Flamant, R., & Lellouch, J.Clinical trials. London: Academic Press, 1980.Google Scholar