Thrombolysis for acute ischaemic strokeBMJ 2002; 325 doi: http://dx.doi.org/10.1136/bmj.325.7376.1363 (Published 07 December 2002) Cite this as: BMJ 2002;325:1363
Trial participants need to be informed of uncertainty principle
- Howard Mann, associate professor ([email protected])
- Department of Radiology, 1A71 University Hospital, 50 North Medical Drive, Salt Lake City, UT 84132, USA
- “Saionara,” 31 Regent Street, Rowhedge, Colchester CO5 7EA
EDITOR—Koops and Lindley involved consumers in the design of a randomised trial of thrombolysis in acute stroke and published the associated patient information sheet. 1 2 Critical appraisal of trial information leaflets benefits the manner in which they are conceived and formulated.
In addition to a limited number of eligibility criteria, the trial notably uses the uncertaintyprinciple for determining eligibility of patients.3 The multicentre research ethics committee requested an explanation of this principle in lay language in the information sheet: Your doctor believes that there is no proof that rt-PA will definitely help you. If your doctor was convinced that you should be given the new treatment (for whatever reason) you would have been given it. If your doctor believed that you should definitely avoid rt-PA treatment, you will not receive it and you would not be invited to join this sort of study. Having weighed up the pros and cons of treatment your doctor feels there is “an absence of proof” for rt-PA for your particular circumstances. You are therefore eligible for the trial.
Uncertainty may be present at …
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