Participation in pediatric egidemiologic research: The SEARCH for Diabetes in Youth Study experience
ABSTRACT We evaluated the association of demographic and clinical characteristics with participation in an epidemiologic study of diabetes mellitus among youth.
SEARCH for Diabetes in Youth is a multicenter study of physician-diagnosed diabetes in youth under the age of 20 comprising a surveillance and a cohort component. At each center, we enumerated all prevalent cases of diabetes in 2001 (n=6266) and all incident cases between 2002 and 2004 (n=3668). After confirmation of eligibility and validation, we invited each case to complete a survey and participate in a study visit. Here we evaluate how age, sex, race, and diabetes type are associated with participation in the survey and study visit.
Among prevalent cases, participation in the survey was 68% and 41% in the study visit. Among 2002 to 2004 incident cases, participation varied for the survey (76%, 81%, and 82%) and study visit (52%, 60%, and 60%). In multivariate logistic regression analyses among all incident cases, older age was associated with a lower odds of participation in the study visit (15-17 vs. <10 years: OR 0.5, 95% CI 0.4-0.7; 18-19 vs. <10 years: OR 0.3, 95% CI 0.2-0.5), as was having type 2 diabetes vs. type 1 diabetes (OR 0.5, 95% CI 0.4-0.7) and being of African American race vs. non-Hispanic White (OR 0.6, 95% CI 0.4-0.8). Results were very similar among prevalent cases.
Elucidating the relationship between individual characteristics and participation is essential for evaluating nonresponse bias, correcting for it, and for planning and implementing recruitment strategies.
SourceAvailable from: Michael R DeBaun[Show abstract] [Hide abstract]
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.ProcedureDifferences 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.ResultsOf 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 Wiley Periodicals, Inc.Pediatric Blood & Cancer 04/2014; 61(9). DOI:10.1002/pbc.25072 · 2.35 Impact Factor
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ABSTRACT: To better understand and overcome difficulties with recruitment of adolescents with type 2 diabetes into clinical trials at three United States institutions, we reviewed recruitment and retention strategies in clinical trials of youth with various chronic conditions. We explored whether similar strategies might be applicable to pediatric patients with type 2 diabetes. We compiled data on recruitment and retention of adolescents with type 2 diabetes at three centers (National Institutes of Health, Bethesda, Maryland; Baylor College of Medicine, Houston, Texas; and Children's National Medical Center, Washington, DC) from January 2009 to December 2011. We also conducted a thorough literature review on recruitment and retention in adolescents with chronic health conditions. The number of recruited patients was inadequate for timely completion of ongoing trials. Our review of recruitment strategies in adolescents included monetary and material incentives, technology-based advertising, word-of-mouth referral, and continuous patient-research team contact. Cellular or Internet technology appeared promising in improving participation among youths in studies of various chronic conditions and social behaviors. Adolescents with type 2 diabetes are particularly difficult to engage in clinical trials. Monetary incentives and use of technology do not represent "magic bullets," but may presently be the most effective tools. Future studies should be conducted to explore motivation in this population. We speculate that (1) recruitment into interventional trials that address the main concerns of the affected youth (e.g., weight loss, body image, and stress management) combined with less tangible outcomes (e.g., blood glucose control) may be more successful; and (2) study participation and retention may be improved by accommodating patients' and caregivers' schedules, by scheduling study visits before and after working hours, and in more convenient locations than in medical facilities.Journal of Adolescent Health 10/2013; 54(3). DOI:10.1016/j.jadohealth.2013.08.017 · 2.75 Impact Factor
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ABSTRACT: Aims To assess associations between race/ethnicity, glycated hemoglobin (HbA1c), and glycemic control among youth with type 1 (T1D) or type 2 diabetes (T2D). Methods The study sample was youth < 20 years old from the SEARCH California Center diagnosed from 2002–2009 who remained insured for at least one year. HbA1c at one year was from clinical data; HbA1c at diagnosis was from clinical data (81%) or imputed (19%). Multivariable logistic and linear regression models were used to examine associations between race/ethnicity and poor glycemic control (≥ 9.5%), HbA1c at one-year, and change in HbA1c. Results The study included 1,162 Hispanic (52.3%), non-Hispanic White (NHW, 28.4%), African American (15.1%) and Asian/Pacific Islander (4.1%) youth. Among T1D youth (n = 789), Hispanics were 1.60 times as likely (95% CI 1.01-2.53) to have poor control at one year compared to NHWs, after adjustments. Among T2D youth (n = 373), only African American youth were significantly more likely (OR = 4.85; 95% CI 1.49-15.77) to have poor control at one year, after adjustments. HbA1c at one year and change in HbA1c did not differ by race/ethnicity. Conclusion Poor glycemic control was evident one year after diagnosis in some minority youth with T1D or T2D in an integrated managed health care setting.Journal of diabetes and its complications 05/2014; DOI:10.1016/j.jdiacomp.2014.01.010 · 2.11 Impact Factor
Angela D Liese