Hostname: page-component-78c5997874-xbtfd Total loading time: 0 Render date: 2024-11-15T09:01:46.676Z Has data issue: false hasContentIssue false
  • English
  • Français

Evaluating New Treatments and Diagnostic Technologies in Obstetrics: Practical Problems, Ethics, and Solutions

Published online by Cambridge University Press:  10 March 2009

Richard J. Lilford
Richard J. Lilford
Affiliation:
The University of Leeds
Get access Rights & Permissions [Opens in a new window]

Extract

This article develops arguments for the use of decision theory, rather than intuition, to determine the size of trials. It is wrong to expect doctors to ignore personal preferences in favor of clinical experiments unless the trial is capable of showing differences in treatment effect that would influence clinical practice substantially. It follows from our analysis that if delta (the treatment effect that the trial is designed to detect) is sufficient to alter clinical practice, then the alpha and beta errors of a trial should be equal. This applies even if a new treatment is to be compared with conventional therapy or if a treatment with high “costs” is compared with a less invasive or more inexpensive method.

Type
Special Section: Technology Assessment and Surgical Policy
Information
International Journal of Technology Assessment in Health Care , Volume 5 , Issue 3 , July 1989 , pp. 459 - 472
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

Altman, D. G.Size of clinical trials. British Medical Journal, 1983, 286, 1842–43.CrossRefGoogle ScholarPubMed
Barrett, J. F. R., Tyrrell, S., & Lilford, R. J.Prolonged pregnancy. British Medical Journal, 1987, 295, 56–7.CrossRefGoogle Scholar
Bingham, P., Lilford, R. J.The management of the selected term breech presentation: Assessment of the risk of selected vaginal delivery versus Caesarean section for all cases. Obstetrics and Gynecology, 1987, 69, 965–78.Google ScholarPubMed
Chalmers, I., Hetherington, J., Newdick, M. et al. The Oxford database of perinatal trials: Developing a register of published reports of controlled trials. Controlled Clinical Trials, 1986, 7, 306–24.CrossRefGoogle ScholarPubMed
Chalmers, I., Sinclair, J. C.Promoting perinatal health: Is it time for a change in emphasis in research? Early Human Development, 1985, 10, 171–91.CrossRefGoogle ScholarPubMed
Coronary Drug Project Research Group. Influence of adherence to treatment and response on cholesterol and on mortality in the coronary drug. New England Journal of Medicine, 1980, 303, 1038–41.CrossRefGoogle Scholar
DeBono, M., Fawdry, R., & Lilford, R. J. Decision theory to determine the size of the trial required to evaluate tests of fetal well-being. Submitted for publication, 1989.Google Scholar
Dudley, H. A. F.Stones, lithotripters and arguments. British Medical Journal, 1986, 292, 846–47.CrossRefGoogle ScholarPubMed
Freedman, B.Equipoise and the ethics of clinical research. New England Journal of Medicine, 1987, 317, 141–45.CrossRefGoogle ScholarPubMed
Lilford, R. J.Clinical experimentation in obstetrics. British Medical Journal, 1987, 295, 1298–1300.CrossRefGoogle ScholarPubMed
Lilford, R. J., & Anscombe, G. E. M.Sins of omission? The non-treatment of controls in clinical trials. Aristotelian Society, 1983, 57, 297–322.Google Scholar
Lowry, S.New Zealand smear trials risked lives. British Medical Journal, 1988, 297, 507–08.Google ScholarPubMed
MacDonald, D., Grant, A., Sheridan-Pereira, M., Boylan, P., & Chalmers, I. The Dublin randomised controlled trial of intrapartum fetal heart rate monitoring. American Journal of Obstetrics and Gynecology, 1985, 152–9.CrossRefGoogle Scholar
McNaughton, M. C., Chalmers, I. G., & Chamberlain, G. V. P.MRC/RCOG working party on cervical cerclage. British Journal of Obstetrics and Gynaecology, 1988, 95, 437–45.Google Scholar
Matthews, D.Clinical experimentation in obstetrics. British Medical Journal, 1988, 296, 66.CrossRefGoogle Scholar
Mowbray, J. F., Gibbings, C., Liddell, R., Reginald, P. W., Underwood, J. L., & Beard, R. W.Controlled trial of treatment of recurrent spontaneous abortion by immunization with potential cells. Lancet, 1985, 1, 941–43.CrossRefGoogle Scholar
Spellacy, W. M., Buhl, W. C., & Berk, S. A.The effectiveness of HPL measurement as an adjunct in decreasing perinatal death. American Journal of Obstetrics and Gynecology, 1975, 121, 835–39.Google Scholar
Tabor, A., Philip, J., Madsen, M., Bang, J., Obel, F. B., Norgaard-Pedersen, . Randomised controlled trial of genetic amniocentesis in 4606 low risk women. Lance, 1986, 1287–93.CrossRefGoogle Scholar
Thornton, J., & Lilford, R. J.When a woman asks for a Caeserean section. British Medical Journal, 1987, 294, 703.CrossRefGoogle Scholar
Torrance, G. W.Measurement of the health state utilities for economic appraisal: A review. Journal of Health Economics, 1986, 5, 1–30.CrossRefGoogle Scholar
Williams, N. R., Lilford, R. J., & Osbourne, J.A basic programme to perform power calculations. Computers in Patient Care Survey, 1987, 4, 4–7.Google Scholar