The DOI matches its Crossref record; 40 of the 40 references it cites were found in a registry or an index.
A predictive approach to selecting the size of a clinical trial, based on subjective clinical opinion
Abstract
The ‘textbook’ approach to determining sample size in a clinical trial has some fundamental weaknesses which we discuss. We describe a new predictive method which takes account of prior clinical opinion about the treatment difference. The method adopts the point of clinical equivalence (determined by interviewing the clinical participants) as the null hypothesis. Decision rules at the end of the study are based on whether the interval estimate of the treatment difference (classical or Bayesian) includes the null hypothesis. The prior distribution is used to predict the probabilities of making the decisions to use one or other treatment or to reserve final judgement. It is recommended that sample size be chosen to control the predicted probability of the last of these decisions. An example is given from a multi‐centre trial of superficial bladder cancer.
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Cites
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Cited by
Bayesian approaches to randomized trials
Spiegelhalter, D. J., Freedman, L. S., & Parmar, M. K. B. (1994) · Journal of the Royal Statistical Society. Series A (Statistics in Society) · doi:10.2307/2983527 · Cited by 720
Self-citationGoodman, S. N., & Berlin, J. A. (1994) · Annals of Internal Medicine · doi:10.7326/0003-4819-121-3-199408010-00008 · Cited by 654
Noninvasive ventilation to prevent respiratory failure after extubation in high-risk patients*
Nava, S., Gregoretti, C., Fanfulla, F., Squadrone, E., Grassi, M., Carlucci, A., Beltrame, F., & Navalesi, P. (2005) · Critical Care Medicine · doi:10.1097/01.ccm.0000186416.44752.72 · Cited by 552
Probabilistic prediction in patient management and clinical trials
Spiegelhalter, D. J. (1986) · Statistics in Medicine · doi:10.1002/sim.4780050506 · Cited by 358
Self-citationMonitoring clinical trials: Conditional or predictive power?
Spiegelhalter, D. J., Freedman, L. S., & Blackburn, P. R. (1986) · Controlled Clinical Trials · doi:10.1016/0197-2456(86)90003-6 · Cited by 307
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Metadata
- Authors
- Spiegelhalter, D. J., & Freedman, L. S.
- Venue
- Statistics in Medicine
- Publisher
- Wiley
- Published
- 1986-01
- Volume
- 5
- Issue
- 1
- Pages
- 1-13
- ISSN
- 0277-6715 (ISSN-L)
- 1097-0258
- OpenAlex
- W1971051509
- Cited by
- 276
- References
- 40
- FWCI
- 9.84
- Type
- journal article
- Language
- en
- Open access
- closed
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