Barriers to enrollment in a pediatric critical care biorepository

Paquette, Erin Talati; Shukla, Avani; Smith, Tracie; Pendergrast, Tricia; Duyar, Susan; Rychlik, Karen; Davis, Matthew M.

doi:10.1038/s41390-023-02465-w

Cited by 8 publications

(13 citation statements)

References 15 publications

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“…These findings are consistent with previously observed recruitment disparities in adults from underserved populations . In pediatrics, the relationship between socioeconomic status (SES) and research enrollment is poorly described, and with conflicting results . We also found that Black parents enrolled their infants in HEAL less frequently than White parents.…”

Section: Discussionsupporting

confidence: 91%

“…27 In pediatrics, the relationship between socioeconomic status (SES) and research enrollment is poorly described, and with conflicting results. 10,16,28 We also found that Black parents enrolled their infants in HEAL less frequently than White parents. The association between the a Using Hall's 4-item trust in medical research scale 19 with mean (SD) score indexed to a 100-point scale.…”

Section: Infant Characteristics and Parental Demographic Characteristicsmentioning

confidence: 99%

“…[33][34][35] Establishing community partnerships and building relationships with underrepresented populations are also important. 27 Enrollment of racial and ethnic minorities in pediatric clinical research, though less well-studied, is lower than for White children including within critical care, 28,36 oncology, 37 and neonatology. 11,12 Conversely, assessments of published articles in 3 general pediatric journals found overrepresentation of Black participants and underrepresentation of Hispanic participants when comparing with US Census Bureau data.…”

Section: Jama Network Open | Pediatricsmentioning

confidence: 99%

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Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial

et al. 2021

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IMPORTANCE It remains poorly understood how parents decide whether to enroll a child in a neonatal clinical trial. This is particularly true for parents from racial or ethnic minority populations.Understanding factors associated with enrollment decisions may improve recruitment processes for families, increase enrollment rates, and decrease disparities in research participation. OBJECTIVE To assess differences in parental factors between parents who enrolled their infant and those who declined enrollment for a neonatal randomized clinical trial. DESIGN, SETTING, AND PARTICIPANTSThis survey study conducted from July 2017 to October 2019 in 12 US level 3 and 4 neonatal intensive care units included parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial or who were eligible but declined enrollment. Data were analyzed October 2019 through July 2020. EXPOSURE Parental choice of enrollment in neonatal clinical trial. MAIN OUTCOMES AND MEASURES Percentages and odds ratios (ORs) of parent participation as categorized by demographic characteristics, self-assessment of child's medical condition, study comprehension, and trust in medical researchers. Survey questions were based on the hypothesis that parents who enrolled their infant in HEAL differ from those who declined enrollment across 4 categories: (1) infant characteristics and parental demographic characteristics, (2) perception of infant's illness, (3) study comprehension, and (4) trust in clinicians and researchers. RESULTSOf a total 387 eligible parents, 269 (69.5%) completed the survey and were included in analysis. This included 183 of 242 (75.6%) of HEAL-enrolled and 86 of 145 (59.3%) of HEAL-declined parents. Parents who enrolled their infant had lower rates of Medicaid participation (74 [41.1%] vs 47 [55.3%]; P = .04) and higher rates of annual income greater than $55 000 (94 [52.8%] vs 30 [37.5%]; P = .03) compared with those who declined. Black parents had lower enrollment rates compared with White parents (OR, 0.35; 95% CI, 0.17-0.73). Parents who reported their infant's medical condition as more serious had higher enrollment rates (OR, 5.7; 95% CI, 2.0-16.3). Parents who enrolled their infant reported higher trust in medical researchers compared with parents who declined (mean [SD] difference, 5.3 [0.3-10.3]). There was no association between study comprehension and enrollment. CONCLUSIONS AND RELEVANCEIn this study, the following factors were associated with neonatal clinical trial enrollment: demographic characteristics (ie, race/ethnicity, Medicaid status, and (continued) Key Points Question How do parents with infants enrolled in a neonatal clinical trial differ from those who decline participation? Findings In this survey study including 269 parent responses, participants who enrolled their infant had different demographic characteristics (lower rate of Medicaid participation, higher income, less likely to identify as Black), reported their infant's medical condition as more serious, and reported ...

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Section: Discussionsupporting

confidence: 91%

Section: Infant Characteristics and Parental Demographic Characteristicsmentioning

confidence: 99%

Section: Jama Network Open | Pediatricsmentioning

confidence: 99%

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Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial

et al. 2021

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“…1 Underrepresentation of Black and Hispanic children has been documented in pediatric critical care and oncology research. [2][3][4] Although data from neonatal research are limited, those available suggest similar underrepresentation. Within neonatal research, Black infants were less likely to enroll in Neonatal Research Network studies compared with Hispanic or White infants.…”

Section: Introductionmentioning

confidence: 99%

“…Difficulty recruiting from marginalized populations, such as Black communities, is a prevalent and long-standing problem in adult medical research . Underrepresentation of Black and Hispanic children has been documented in pediatric critical care and oncology research . Although data from neonatal research are limited, those available suggest similar underrepresentation.…”

Section: Introductionmentioning

confidence: 99%

Race and Ethnicity of Infants Enrolled in Neonatal Clinical Trials

Lyle,

Shaikh,

Oslin

et al. 2023

JAMA Netw Open

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ImportanceRepresentativeness of populations within neonatal clinical trials is crucial to moving the field forward. Although racial and ethnic disparities in research inclusion are well documented in other fields, they are poorly described within neonatology.ObjectiveTo describe the race and ethnicity of infants included in a sample of recent US neonatal clinical trials and the variability in this reporting.Evidence ReviewA systematic search of US neonatal clinical trials entered into Cochrane CENTRAL 2017 to 2021 was conducted. Two individuals performed inclusion determination, data extraction, and quality assessment independently with discrepancies adjudicated by consensus.FindingsOf 120 studies with 14 479 participants that met the inclusion criteria, 75 (62.5%) included any participant race or ethnicity data. In the studies that reported race and ethnicity, the median (IQR) percentage of participants of each background were 0% (0%-1%) Asian, 26% (9%-42%) Black, 3% (0%-12%) Hispanic, 0% (0%-0%) Indigenous (eg, Alaska Native, American Indian, and Native Hawaiian), 0% (0%-0%) multiple races, 57% (30%-68%) White, and 7% (1%-21%) other race or ethnicity. Asian, Black, Hispanic, and Indigenous participants were underrepresented, while White participants were overrepresented compared with a reference sample of the US clinical neonatal intensive care unit (NICU) population from the Vermont Oxford Network. Many participants were labeled as other race or ethnicity without adequate description. There was substantial variability in terms and methods of reporting race and ethnicity data. Geographic representation was heavily skewed toward the Northeast, with nearly one-quarter of states unrepresented.Conclusions and RelevanceThese findings suggest that neonatal research may perpetuate inequities by underrepresenting Asian, Black, Hispanic, and Indigenous neonates in clinical trials. Studies varied in documentation of race and ethnicity, and there was regional variation in the sites included. Based on these findings, funders and clinical trialists are advised to consider a 3-point targeted approach to address these issues: prioritize identifying ways to increase diversity in neonatal clinical trial participation, agree on a standardized method to report race and ethnicity among neonatal clinical trial participants, and prioritize the inclusion of participants from all regions of the US in neonatal clinical trials.

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Racial and Ethnic Disparity in Approach for Pediatric Intensive Care Unit Research Participation

Mayer,

Brajcich,

Juste

et al. 2024

JAMA Netw Open

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ImportanceWhile disparities in consent rates for research have been reported in multiple adult and pediatric settings, limited data informing enrollment in pediatric intensive care unit (PICU) research are available. Acute care settings such as the PICU present unique challenges for study enrollment, given the highly stressful and emotional environment for caregivers and the time-sensitive nature of the studies.ObjectiveTo determine whether race and ethnicity, language, religion, and Social Deprivation Index (SDI) were associated with disparate approach and consent rates in PICU research.Design, Setting, and ParticipantsThis retrospective cohort study was performed at the Children’s Hospital of Philadelphia PICU between July 1, 2011, and December 31, 2021. Participants included patients eligible for studies requiring prospective consent. Data were analyzed from February 2 to July 26, 2022.ExposureExposures included race and ethnicity (Black, Hispanic, White, and other), language (Arabic, English, Spanish, and other), religion (Christian, Jewish, Muslim, none, and other), and SDI (composite of multiple socioeconomic indicators).Main Outcomes and MeasuresMultivariable regressions separately tested associations between the 4 exposures (race and ethnicity, language, religion, and SDI) and 3 outcomes (rates of approach among eligible patients, consent among eligible patients, and consent among those approached). The degree to which reduced rates of approach mediated the association between lower consent in Black children was also assessed.ResultsOf 3154 children included in the study (median age, 6 [IQR, 1.9-12.5] years; 1691 [53.6%] male), rates of approach and consent were lower for Black and Hispanic families and those of other races, speakers of Arabic and other languages, Muslim families, and those with worse SDI. Among children approached for research, lower consent odds persisted for those of Black race (unadjusted odds ratio [OR], 0.73 [95% CI, 0.55-0.97]; adjusted OR, 0.68 [95% CI, 0.49-0.93]) relative to White race. Mediation analysis revealed that 51.0% (95% CI, 11.8%-90.2%) of the reduced odds of consent for Black individuals was mediated by lower probability of approach.Conclusions and RelevanceIn this cohort study of consent rates for PICU research, multiple sociodemographic factors were associated with lower rates of consent, partly attributable to disparate rates of approach. These findings suggest opportunities for reducing disparities in PICU research participation.

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Barriers to enrollment in a pediatric critical care biorepository

Cited by 8 publications

References 15 publications

Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial

Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial

Race and Ethnicity of Infants Enrolled in Neonatal Clinical Trials

Racial and Ethnic Disparity in Approach for Pediatric Intensive Care Unit Research Participation

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