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

Dionna O. Roberts, Brittany Covert, Mark J. Rodeghier, Nagina Parmar, Michael R. Debaun*, Alexis A Thompson, Robert I Liem

*Corresponding author for this work

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1529-1535
Number of pages7
JournalPediatric Blood and Cancer
Volume61
Issue number9
DOIs
StatePublished - Jan 1 2014

Fingerprint

Sickle Cell Anemia
Random Allocation
Economics
Demography
Clinical Trials
Chronic Disease
Research Personnel
Education

Keywords

  • Clinical trials
  • Randomization
  • Research participation
  • Sickle cell disease
  • Study recruitment

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Hematology
  • Oncology

Cite this

Roberts, Dionna O. ; Covert, Brittany ; Rodeghier, Mark J. ; Parmar, Nagina ; Debaun, Michael R. ; Thompson, Alexis A ; Liem, Robert I. / Randomization is not associated with socio-economic and demographic factors in a multi-center clinical trial of children with sickle cell anemia. In: Pediatric Blood and Cancer. 2014 ; Vol. 61, No. 9. pp. 1529-1535.
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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.",
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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. / Roberts, Dionna O.; Covert, Brittany; Rodeghier, Mark J.; Parmar, Nagina; Debaun, Michael R.; Thompson, Alexis A; Liem, Robert I.

In: Pediatric Blood and Cancer, Vol. 61, No. 9, 01.01.2014, p. 1529-1535.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Randomization is not associated with socio-economic and demographic factors in a multi-center clinical trial of children with sickle cell anemia

AU - Roberts, Dionna O.

AU - Covert, Brittany

AU - Rodeghier, Mark J.

AU - Parmar, Nagina

AU - Debaun, Michael R.

AU - Thompson, Alexis A

AU - Liem, Robert I

PY - 2014/1/1

Y1 - 2014/1/1

N2 - 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.

AB - 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.

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KW - Randomization

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KW - Study recruitment

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DO - 10.1002/pbc.25072

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