From published data,we estimated that the PWT would
improve by 60% with OMC, 125% with SE, and 164% with ST.
Given a baseline mean PWT estimate of 5.0 minutes (SD, 3.8
minutes), with 63 evaluable participants in both the ST and SE
groups or 158 participants total between ST, SE, and OMC, the study
had 80% power to detect the difference between SE and ST, 99%
power for the ST versus OMC comparison, and 98% power for SE
versus OMC. Allowing for 30% premature withdrawal and inclusion
of an exploratory arm of ST plus SE, we planned a sample size of
252. The sample size was adjusted to 217 after removal of the ST
plus SE arm owing to slow enrollment. Although the study did not
meet conservative prespecified stopping rules, recruitment was
stopped early on the recommendations of the Data Safety and
Monitoring Board as a result of slow enrollment after review of the
interim results.
From published data,we estimated that the PWT wouldimprove by 60% with OMC, 125% with SE, and 164% with ST.Given a baseline mean PWT estimate of 5.0 minutes (SD, 3.8minutes), with 63 evaluable participants in both the ST and SEgroups or 158 participants total between ST, SE, and OMC, the studyhad 80% power to detect the difference between SE and ST, 99%power for the ST versus OMC comparison, and 98% power for SEversus OMC. Allowing for 30% premature withdrawal and inclusionof an exploratory arm of ST plus SE, we planned a sample size of252. The sample size was adjusted to 217 after removal of the STplus SE arm owing to slow enrollment. Although the study did notmeet conservative prespecified stopping rules, recruitment wasstopped early on the recommendations of the Data Safety andMonitoring Board as a result of slow enrollment after review of theinterim results.
การแปล กรุณารอสักครู่..
