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  • Original Article
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Multiples and parents of multiples prefer same arm randomization of siblings in neonatal trials

Journal of Perinatology volume 35, pages 208–213 (2015)Cite this article

Subjects

A Corrigendum to this article was published on 27 March 2015

Abstract

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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Acknowledgements

We would like to thank all organizations who helped distribute the survey and all survey participants for their valued assistance and insight. ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, grants UL1TR000445 and 1U54RR032646-01. The Clinical and Translational Science Collaborative (CTSC) grant supports (UL1TR000439) RedCap databases.

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Authors and Affiliations

  1. Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, OH, USA

    J Bernardo & A Nowacki

  2. Case Western Reserve University School of Medicine, Cleveland, OH, USA

    J Bernardo, R Martin, J M Fanaroff & A M Hibbs

  3. Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, OH, USA

    A Nowacki

  4. Division of Neonatology, Rainbow Babies and Children’s Hospital, Cleveland, OH, USA

    R Martin, J M Fanaroff & A M Hibbs

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  1. J Bernardo
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  2. A Nowacki
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  3. R Martin
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  4. J M Fanaroff
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  5. A M Hibbs
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Corresponding author

Correspondence to J Bernardo.

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The authors declare no conflict of interest.

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Supplementary Information accompanies the paper on the Journal of Perinatology website

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Bernardo, J., Nowacki, A., Martin, R. et al. Multiples and parents of multiples prefer same arm randomization of siblings in neonatal trials. J Perinatol 35, 208–213 (2015). https://doi.org/10.1038/jp.2014.192

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  • DOI: https://doi.org/10.1038/jp.2014.192

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