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Multiples and parents of multiples prefer same arm randomization of siblings in neonatal trials
J Bernardo1, A Nowacki2, R Martin3
11] Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, OH, USA [2] Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Objective:
Although common among Neonatal Intensive Care Units, multiples births are randomized inconsistently within trials, which can impact enrollment, analytical approach and trial outcomes. It is not known what randomization approach (same arm, different arm and independent randomization) is preferred by multiples and their families.
Study Design:
Surveys distributed to parents of multiples and adult multiples addressed the preferences on randomization by eliciting the most desired method and likelihood of enrolling twins for each randomization approach.
Result:
Populations included 209 parents and 321 adult multiples. Seventy-eight percent of parents and 59% of multiples prefer same arm placement of multiples over other methods (both P<0.001), which also had highest likelihood of enrollment among both the groups.
Conclusion:
Parents of multiples and adult multiples prefer placement of multiples into same treatment arm in randomized trials, making such methodology a potential way to optimize consent rates while ethically approaching human subject research.
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