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One sees that accruing additional patients while the initial patients are followed results in a greater expected sample size, but shorter expected and maximum total study lengths.
* ESS is the expected sample size; MDA is the maximum duration of accrual; ETSL and MTSL are the expected and maximum total study length, respectively.
As illustrated below, let t1 and t2 denote the duration of the first and second accrual periods, and let MTSL denote the maximum total study length (MTSL = t1 + t2 + x*).
By considering all possible designs, one can choose a design that is almost optimal but which has a smaller sample size and maximum total study length than that of the fully optimal design.
* t1 is the time of the first interim review; C1 and C2 are the cutpoints for acceptance at the first stage and rejection at the second stage; EDA and MDA are the expected and maximum duration of accrual; and ETSL and MTSL are the expected and maximum total study length.
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The costs of these designs are maximum sample sizes and total study lengths that are greater than the fixed sample values.
In the total study a maximum of 1638 cystic lesions (182 patients times nine anatomic locations) could be scored.
In the total study a maximum of 1,638 BME lesions (182 patients times nine anatomic locations) could be scored.
However, the maximum duration of accrual and total study length are reached fairly quickly and then decrease with increasing time to the interim analysis.
The expected and maximum duration of accrual and total study lengths for these designs are also listed in Table 1 for comparison with the single stage and Simon two-stage designs.
The results of this evaluation were summed with a maximum total possible score of 8. Study outcomes were assessed for success in each of our three domains of focus: 'Implementation', 'Change in Health Care Provider Behaviour', and 'Change in Patient Outcomes'.
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