Parental Enrollment Decision-Making for a Neonatal Clinical Trial

Weiss, Elliott Mark; Guttmann, Katherine; Olszewski, Aleksandra E.; Magnus, Brooke E.; Li, Sijia; Kim, Scott Y. H.; Shah, Anita; Juul, Sandra E.; Wu, Yvonne W.; Ahmad, Kaashif A.; Bendel-Stenzel, Ellen; Isaza, Natalia; Lampland, Andrea; Mathur, Amit M.; Rao, Rakesh; Riley, David M.; Russell, David G.; Salih, Zeynep N. Inanc; Torr, Carrie B.; Weitkamp, Jörn-Hendrik; Anani, Uchenna E.; Chang, Taeun; Dudley, Juanita; Flibotte, John; Havrilla, Erin M.; O'Kane, A; Perez, Krystle; Stanley, Brenda J.; Shah, Seema; Wilfond, Benjamin S.

doi:10.1016/j.jpeds.2021.08.014

Cited by 17 publications

(11 citation statements)

References 34 publications

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“…Language differences may also be a reason for not approaching certain groups, and processes can be put in place to overcome this barrier, such as hiring interpreters or multilingual research staff. Parents may differently consider reasons for and against participation when deciding whether to participate in research . Certain burdens of participation may be an annoyance for well-resourced individuals but deeply problematic for individuals with fewer resources .…”

Section: Discussionmentioning

confidence: 99%

“…Parents may differently consider reasons for and against participation when deciding whether to participate in research. 22,151 Certain burdens of participation may be an annoyance for well-resourced individuals but deeply problematic for individuals with fewer resources. 152 Ways to improve the enrollment processes, support relationship building between researchers and parents of potential participants, 153 and decrease the burdens of participation should be considered as key targets of future work to decrease disparities in participation.…”

Section: Underrepresentation Of Minoritized Racial and Ethnic Populat...mentioning

confidence: 99%

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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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Section: Discussionmentioning

confidence: 99%

Section: Underrepresentation Of Minoritized Racial and Ethnic Populat...mentioning

confidence: 99%

Race and Ethnicity of Infants Enrolled in Neonatal Clinical Trials

Lyle,

Shaikh,

Oslin

et al. 2023

JAMA Netw Open

Self Cite

View full text Add to dashboard Cite

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“…However, parents or guardians are often distressed due to their own medical condition or that of their newborn, which can impact their ability to fully comprehend and engage in the informed consent process. 7,8 In some situations, the mother may be medicated or in pain, affecting her ability to make informed decisions. 9 Sometimes, parents are simply unavailable in person when emergency decisions need to be made for their child.…”

Section: Challeng E S In Obtaining Informed Con S Ent For Neonatal Re...mentioning

confidence: 99%

Practical approaches for supporting informed consent in neonatal clinical trials

Wootton,

Rysavy,

Davis

et al. 2024

Acta Paediatrica

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The survival and health of preterm and critically ill infants have markedly improved over the past 50 years, supported by well‐conducted neonatal research. However, newborn research is challenging to undertake for many reasons, and obtaining informed consent for research in this population presents several unique ethical and logistical challenges. In this article, we explore methods to facilitate the consent process, including the role of checklists to support meaningful informed consent for neonatal clinical trials.ConclusionThe authors provide practical guidance on the design and implementation of an effective consent checklist tailored for use in neonatal clinical research.

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“…Thus, the recruitment of parental smokers into tobacco cessation interventions may potentially have a high impact, resulting in large decreases in adult tobacco use and reductions in pediatric tobacco smoke exposure (TSE)-related morbidity [ 5 , 14 , 15 , 16 ]. Despite the growing number of studies about barriers and limitations to participating in a RCT [ 9 , 17 , 18 , 19 , 20 , 21 ], there is a research gap in our understanding of the barriers in parents’ willingness to participate in a RCT in the PED or UC setting in which the parent and not the pediatric patient is the targeted research participant. This information is needed to maximize costly recruitment and enrollment efforts and to obtain the targeted study sample size needed to adequately assess study outcomes in RCTs [ 22 ].…”

Section: Introductionmentioning

confidence: 99%

“I Don’t Want My Child to Be a Guinea Pig”: Reasons for Non-Participation in a Parental Tobacco Cessation Trial in the Pediatric Emergency Department Setting

Toraman

Merianos

Stone

et al. 2023

Toxics

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(1) Background: Pediatric emergency department (PED) settings are opportune venues in which to recruit parental smokers into tobacco cessation interventions. However, the barriers associated with parents’ participation in PED-based cessation trials are unknown. The objectives were to explore parents’ reasons for non-participation in a PED-based tobacco cessation trial. (2) Methods: We employed the framework method and conducted a qualitative data analysis of parental smokers who were eligible to participate in a PED-based tobacco cessation trial and did not choose to participate (n = 371). (3) Results: Two main themes emerged about reasons for non-participation: (a) Not interested in participating in a research study, and (b) concerns specific to the study. Parents had various reasons for not participating in the cessation trial including not being interested in quitting, parents’ health and well-being, parents’ beliefs about research, and time required for the study and follow-up visits. (4) Conclusion: General disinterest and specific study-related concerns were touted as reasons for non-participation in a PED-based tobacco cessation trial. Given the potential reductions in tobacco-related morbidity to both parents and children that tobacco control interventions can facilitate, future tobacco interventions should consider alterations in study design and recruitment strategies to encourage all eligible parental smokers to participate.

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Parental Enrollment Decision-Making for a Neonatal Clinical Trial

Cited by 17 publications

References 34 publications

Race and Ethnicity of Infants Enrolled in Neonatal Clinical Trials

Race and Ethnicity of Infants Enrolled in Neonatal Clinical Trials

Practical approaches for supporting informed consent in neonatal clinical trials

“I Don’t Want My Child to Be a Guinea Pig”: Reasons for Non-Participation in a Parental Tobacco Cessation Trial in the Pediatric Emergency Department Setting

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