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

Pediatric Blood and Cancer

Volumn 61, Issue 9, 2014, Pages 1529-1535

  Roberts, Dionna O ^a   Covert, Brittany ^a   Rodeghier, Mark J ^b   Parmar, Nagina ^c   Debaun, Michael R ^a   Thompson, Alexis A ^d   Liem, Robert I ^d,e  

^a VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b Rodeghier Consultants   (United States)

^c HOSPITAL FOR SICK CHILDREN   (Canada)

^d CHILDREN'S MEMORIAL HOSPITAL   (United States)

^e NORTHWESTERN UNIVERSITY   (United States)

Author keywords

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

Indexed keywords

ACUTE CHEST SYNDROME; ADOLESCENT; ARTICLE; BLOOD TRANSFUSION; BRAIN INFARCTION; CHILD; CHILD HOSPITALIZATION; CHILDHOOD DISEASE; CLINICAL OBSERVATION; COMPARATIVE STUDY; DEMOGRAPHY; DISEASE COURSE; DOPPLER ECHOGRAPHY; EDUCATIONAL STATUS; FAMILY HISTORY; FEMALE; HOUSEHOLD; HUMAN; INCOME; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NUCLEAR MAGNETIC RESONANCE IMAGING; PAIN; PRIORITY JOURNAL; RANDOMIZATION; SICKLE CELL ANEMIA; SOCIAL STATUS;

CLINICAL TRIALS; RANDOMIZATION; RESEARCH PARTICIPATION; SICKLE CELL DISEASE; STUDY RECRUITMENT;

ADOLESCENT; ANEMIA, SICKLE CELL; BLOOD TRANSFUSION; CEREBRAL INFARCTION; CHILD; CHILD, PRESCHOOL; DEMOGRAPHY; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; PROGNOSIS; SOCIOECONOMIC FACTORS;

EID: 84904440116     PISSN: 15455009     EISSN: 15455017     Source Type: Journal    
DOI: 10.1002/pbc.25072     Document Type: Article

References (25)

1. Katz RV, Green BL, Kressin NR, et al. Exploring the "legacy" of the Tuskegee Syphilis Study: A follow-up study from the Tuskegee Legacy Project. J Natl Med Assoc 2009; 101:179-183.
2. Durant RW, Davis RB, St George DM, et al. Participation in research studies: Factors associated with failing to meet minority recruitment goals. Ann Epidemiol 2007; 17:634-642.
3. Penberthy L, Brown R, Wilson-Genderson M, et al. Barriers to therapeutic clinical trials enrollment: Differences between African-American and white cancer patients identified at the time of eligibility assessment. Clin Trials 2012; 9:788-797.
4. Heiat A, Gross CP, Krumholz HM. Representation of the elderly, women, and minorities in heart failure clinical trials. Arch Intern Med 2002; 162:1682-1688.
5. BeLue R, Taylor-Richardson KD, Lin J, et al. African Americans and participation in clinical trials: Differences in beliefs and attitudes by gender. Contemp Clin Trials 2006; 27:498-505.
6. Shaya FT, Gbarayor CM, Huiwen Keri Y, et al. A perspective on African American participation in clinical trials. Contemp Clin Trials 2007; 28:213-217.
7. Sweet S, Legro RS, Coney P. A comparison of methods and results in recruiting white and black women into reproductive studies: The MMC-PSU cooperative center on reproduction experience. Contemp Clin Trials 2008; 29:478-481.
8. Crawley LM. African-American participation in clinical trials: Situating trust and trustworthiness. J Natl Med Assoc 2001; 93:14S-17S.
9. DeBaun MR, Gorelick PB, Som S. Strategies for recruiting and retaining minorities. Front Neurol Neurosci 2009; 25:118-120.
10. Arega A, Birkmeyer NJ, Lurie JD, et al. Racial variation in treatment preferences and willingness to randomize in the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa1976) 2006; 31:2263-2269.
11. Liese AD, Liu L, Davis C, et al. Participation in pediatric epidemiologic research: The SEARCH for Diabetes in Youth Study experience. Contemp Clin Trials 2008; 29:829-836.
12. Field JJ, DeBaun MR. Asthma and sickle cell disease: Two distinct diseases or part of the same process? Hematology Am Soc Hematol Educ Program 2009; 2009:45-53.
13. Montanaro M, Colombatti R, Pugliese M, et al. Intellectual function evaluation of first generation immigrant children with sickle cell disease: The role of language and sociodemographic factors. Ital J Pediatr 2013; 39:36.
14. Casella JF, King AA, Barton B, et al. Design of the silent cerebral infarct transfusion (SIT) trial. Pediatr Hematol Oncol 2010; 27:69-89.
15. Rivers D, August EM, Sehovic I, et al. A systematic review of the factors influencing African Americans' participation in cancer clinical trials. Contemp Clin Trials 2013; 35:13-32.
16. Gadegbeku CA, Stillman PK, Huffman MD, et al. Factors associated with enrollment of African Americans into a clinical trial: Results from the African American study of kidney disease and hypertension. Contemp Clin Trials 2008; 29:837-842.
17. Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: Race-, sex-, and age-based disparities. JAMA 2004; 291:2720-2726.
18. Lund MJ, Eliason MT, Haight AE, et al. Racial/ethnic diversity in children's oncology clinical trials: Ten years later. Cancer 2009; 115:3808-3816.
19. DeVita DA, White MC, Zhao X, et al. Determinants of subject visit participation in a prospective cohort study of HTLV infection. BMC Med Res Methodol 2009; 9:19.
20. Drotar D, Miller V, Willard V, et al. Correlates of parental participation during informed consent for randomized clinical trials in the treatment of childhood leukemia. Ethics Behav 2004; 14:1-15.
21. Heinrichs N, Bertram H, Kuschel A, et al. Parent recruitment and retention in a universal prevention program for child behavior and emotional problems: Barriers to research and program participation. Prev Sci 2005; 6:275-286.
22. Read K, Fernandez CV, Gao J, et al. Decision-making by adolescents and parents of children with cancer regarding health research participation. Pediatrics 2009; 124:959-965.
23. Liem RI, Cole AH, Pelligra SA, et al. Parental attitudes toward research participation in pediatric sickle cell disease. Pediatr Blood Cancer 2010; 55:129-133.
24. Wynn L, Miller S, Faughnan L, et al. Recruitment of infants with sickle cell anemia to a Phase III trial: Data from the BABY HUG study. Contemp Clin Trials 2010; 31:558-563.
25. Barakat LP, Patterson CA, Mondestin V, et al. Initial development of a questionnaire evaluating perceived benefits and barriers to pediatric clinical trials participation. Contemp Clin Trials 2013; 34:218-226.