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Again order brahmi 60caps visa, the subsequent 22 TEXTBOOK OF CLINICAL TRIALS 20 A significantly better than B 10 0 No significant difference −10 B significantly better than A −20 0 10 20 30 40 50 Number of preferences Open sequential design. The solid lines indicate stopping boundaries for declaring a statistically significant difference between treatments A and B. If the broken boundary is crossed, then the study stops, concluding that no significant difference was found between the treatments. Potentially the number of preferences could continue indefinitely between the upper solid and broken lines or between the lower solid and broken lines; in such a case no conclusion would ever be reached. Open sequential design patients recruited may then be somewhat dif- terms the use of sequential designs is still some- ferent from those at the first stage of the trial. They do not however appear randomised consent design combines aspects of to give an actual clinical example of their use. They were motivated by the difficulties range from difficulties of financing a trial of expressed by clinicians in obtaining consent from uncertain size, making sure the data is fully up- women who they wished to recruit to trials to-date as the trial progresses, to the more tech- with breast cancer. However, Those who were randomised to the standard Whitehead,31 see also Jennison and Turnbull,32 treatment (conventional dressing in Figure 2. On GENERAL ISSUES 23 20 A significantly better than B 10 0 No significant difference −10 B significantly better than A −20 0 10 20 30 40 Number of preferences Closed sequential design. The solid lines indicate stopping boundaries for declaring a statistically significant difference between treatments A and B. For example, if out of ten patients expressing a preference for one or other treatment, nine preferred treatment B and only one preferred A, then the study would stop, concluding that B is significantly better than A. If the broken boundary is crossed, then the study stops and the conclusion is drawn that no significant difference was found between the treatments. Closed sequential design the other hand, those who are randomised to Eligible patients the experimental treatment (MEBO dressing in Figure 2. An alternative is that those randomised to the standard treatment may also Yes No Yes No be asked if they accept that treatment; again, Treat with Treat with Treat with Treat with they are actually given their treatment of choice. Compare The properties of these designs have been 34 Source: After Altman et al. In consent in conjunction with randomisation 24 TEXTBOOK OF CLINICAL TRIALS any event, they have rarely been used in prac- may be of assistance in interpreting the results tice although they continue to be advocated.

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