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Randomization is not associated with socio-economic and demographic factors in a multi-center clinical trial of children with sickle cell anemia

Authors

  • Dionna O. Roberts MPH, MS,

    1. Department of Pediatrics, Division of Hematology/Oncology, Vanderbilt University School of Medicine, Nashville, Tennessee
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  • Brittany Covert MPH,

    1. Department of Pediatrics, Division of Hematology/Oncology, Vanderbilt University School of Medicine, Nashville, Tennessee
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  • Mark J. Rodeghier PhD,

    1. Rodeghier Consultants, Chicago, Illinois
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  • Nagina Parmar PhD, MSc, CCRP,

    1. Division of Hematology/Oncology, Hospital for Sick Children, Toronto, Canada
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  • Michael R. DeBaun MD, MPH,

    Corresponding author
    1. Department of Pediatrics, Division of Hematology/Oncology, Vanderbilt University School of Medicine, Nashville, Tennessee
    • Correspondence to: Michael R. DeBaun, Vanderbilt-Meharry-Matthew Walker Center of Excellence in Sickle Cell Disease, Department of Pediatrics, Vanderbilt University School of Medicine, 2200 Children's Way, Room 11206DOT, Nashville, TN 37232-9000.

      E-mail: m.debaun@vanderbilt.edu

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  • Alexis A. Thompson MD, MPH,

    1. Division of Hematology, Oncology & Stem Cell Transplant, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois
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  • Robert I. Liem MD, MS

    1. Division of Hematology, Oncology & Stem Cell Transplant, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois
    2. Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois
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  • Conflict of interest: Nothing to declare.
  • Roberts and Covert contributed equally to this work.

Abstract

Background

Few studies have investigated factors influencing participation rates for minority children with a chronic disease in clinical trials. The Silent Cerebral Infarct Multi-Center Clinical (SIT) Trial provides an opportunity to study the impact of demographic and socio-economic factors on randomization in a clinical trial among Black children. Our primary objective was to characterize the factors associated with successful randomization of children with sickle cell disease (SCD) and silent cerebral infarct (SCI) in the SIT Trial after initial consent.

Procedure

Differences in socio-economic and demographic variables, family history and disease-related variables were determined between eligible participants who were successfully randomized and those who were not randomized following initial consent. Head of household educational level and family income were examined separately for US versus non-US sites.

Results

Of 1,176 children enrolled in the SIT Trial, 1,016 (86%) completed screening. Of 208 (20%) children with qualifying SCI on pre-randomization MRI, 196 (94%) were successfully randomized. There were no differences in socio-economic, demographic, or disease-related variables between children who were or were not randomized. Participants from non-US sites were more likely to be randomized (22% vs. 12%, P = 0.011); although, randomization by country was associated with neither head of household education nor family income.

Conclusion

In the SIT Trial, acceptance of random allocation was not associated with socio-economic or demographic factors. Although these factors may represent barriers for some participants, they should not bias investigators caring for children with SCD in their approach to recruitment for clinical trial participation. Pediatr Blood Cancer 2014;61:1529–1535. © 2014 Wiley Periodicals, Inc.

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