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Activity Number: 184 - Contributed Poster Presentations: International Chinese Statistical Association
Type: Contributed
Date/Time: Monday, July 30, 2018 : 10:30 AM to 12:20 PM
Sponsor: International Chinese Statistical Association
Abstract #330328
Title: Add a Patient Selected Treatment Arm in a Randomized Trial
Author(s): Xueliang Pan* and Lai Wei and Jill Heathcock
Companies: and The Ohio State University and The Ohio State University
Keywords: Randomized trail; patient-selected arm; clinical trial
Abstract:

The ACHIEVE study is a randomized study to compare the effectiveness of 2 intensities of motor rehabilitation treatment for Cerebral Palsy children: high intensity (2 hr/day x 4 wks) or weekly intensity (2 hr/week x 20 wks). After the trail opened for 12 month, we had significant lag in enroll patients, < 60%(42/75). However, more than 100 families were interested but cannot commit to randomization because they are not able to commit to one or the other group due to schedule limitations. A modification of the study was proposed: keep enrolling patients in the original randomized study, and add a family self-chosen treatment group. Our data analysis plan has been updated: first, the primary analysis will be based on the randomized patients. Next, patients in the nonrandomized arm will analyzed independently, and compare if the treatment effect is consistent with the randomized study. Finally, all patients may be considered in a single multivariate regression analysis, including an indicator variable for randomization status as a covariate, as well as these baseline characteristics that may influence clinical outcomes.


Authors who are presenting talks have a * after their name.

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