Epigenetic Effects on Pediatric Traumatic Brain Injury Recovery (EETR): An Observational, Prospective, Longitudinal Concurrent Cohort Study Protocol

Treble‐Barna, Amery; Patronick, Jamie; Uchani, Srivatsan; Marousis, Noelle C.; Zigler, Christina K.; Fink, Ericka L.; Kochanek, Patrick M.; Conley, Yvette P.; Yeates, Keith Owen

doi:10.3389/fneur.2020.00460

Cited by 7 publications

(8 citation statements)

References 127 publications

(82 reference statements)

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“…However, the reported minimal age required for obtaining pediatric assent varied considerably (between 5 and 13 years) even within North America. Furthermore, only 14% of studies specifying a minimal age actually provided a justification for their choice [ 16 , 29 , 41 , 42 ]. This variability is in keeping with the broader literature in which some authors propose a “school-age threshold”, suggesting “considerable capacities of 5–7 year-old children” [ 43 ] while others advocate that children less than 11 years of age have a limited understanding of research information [ 34 ].…”

Section: Discussionmentioning

confidence: 99%

“…Thirteen studies had a main focus on pediatric assent guidelines. Of these, 53.8% were institutionally based [12,19,[48][49][50][51], 30.8% were study-specific [19,29,46,51] and 23.1% were national or international guidelines [12,14,16]. The majority (76.9%) specified a minimal age, ranging from 4 to 12 years, above which assent should be obtained [14,16,19,46,[48][49][50][51].…”

Section: Studies Focusing On the Description Of Assentmentioning

confidence: 99%

“…Of these, 53.8% were institutionally based [12,19,[48][49][50][51], 30.8% were study-specific [19,29,46,51] and 23.1% were national or international guidelines [12,14,16]. The majority (76.9%) specified a minimal age, ranging from 4 to 12 years, above which assent should be obtained [14,16,19,46,[48][49][50][51]. The majority of the studies referred to North American (61.5%) [12,19,46,[48][49][50][51] and European guidelines (38.5%) [12,14,16,29,46].…”

Section: Studies Focusing On the Description Of Assentmentioning

confidence: 99%

“…The majority (76.9%) specified a minimal age, ranging from 4 to 12 years, above which assent should be obtained [14,16,19,46,[48][49][50][51]. The majority of the studies referred to North American (61.5%) [12,19,46,[48][49][50][51] and European guidelines (38.5%) [12,14,16,29,46]. In 84.6% of the studies, the guidelines did not specify in what manner assent should be obtained (for example written or verbal) and 76.9% did not specify how information should be presented.…”

Section: Studies Focusing On the Description Of Assentmentioning

confidence: 99%

“…Figure 2 shows the frequency of the reported minimum age required for obtaining assent across all studies (n = 28) and within the North American studies alone (n = 20). Seven studies specified criteria used for obtaining assent other than age (see Table 3) [15][16][17][18][19][20][21] and Fig. 3a.…”

Section: Reported Criteria For Seeking Assent In Studies Enrolling Ch...mentioning

confidence: 99%

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Operationalization of assent for research participation in pre-adolescent children: a scoping review

et al. 2022

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Background Seeking assent from children for participation in medical research is an ethical imperative of numerous institutions globally. However, none of these organizations provide specific guidance on the criteria or process to be used when obtaining assent. The primary objective of this scoping review was to determine the descriptions of assent discussed in the literature and the reported criteria used for seeking assent for research participation in pre-adolescent children. Methods Medline and Embase databases were searched until November 2020 using the term “assent” in the title or abstract. Inclusion criteria were (1) studies enrolling children which specifically described operationalization of the assent process and (2) studies of the assent process which provided a description of assent. Data collected included participant information, patient criteria for seeking assent, guidelines referenced, description of assent reported, how assent was obtained and assent information presented, and reported assent rate. For qualitative articles focusing on the assent process, important themes were identified. Results A total of 116 articles were included of which 79 (68.9%) operationalized assent and 57 studies (%) described the assent process. The most commonly reported criterion used to determine the ability of a child to assent was age (35.4%, 28/79). The reported minimal age for obtaining pediatric assent varied considerably across and within jurisdictions (5–13 years; median 7.5 years, IQR 7.0, 9.75). Cognitive ability was reported as a criterion for obtaining assent in 5.1% (4/79) of studies. Assent rates were only reported in 17.7% (14/79) of citations and ranged from 32.0 to 100%. Analysis of the 57 studies describing the assent process identified several themes, including age thresholds, assessment of capacity, variable knowledge of pediatric assent and parental roles. Conclusion We found significant variation in criteria used for assessment of patient capacity, delivery of information used to obtain assent and documentation of the assent process. While we acknowledge that individual children, settings and jurisdictions may require different approaches to obtaining assent, there should be agreement on important principles to be followed with resulting common guidance on assessing capacity, delivering information and documentation of the assent process for publication.

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Section: Discussionmentioning

confidence: 99%

Section: Studies Focusing On the Description Of Assentmentioning

confidence: 99%

Section: Studies Focusing On the Description Of Assentmentioning

confidence: 99%

Section: Studies Focusing On the Description Of Assentmentioning

confidence: 99%

Section: Reported Criteria For Seeking Assent In Studies Enrolling Ch...mentioning

confidence: 99%

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Operationalization of assent for research participation in pre-adolescent children: a scoping review

et al. 2022

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Epigenetics and Brain Plasticity: Back to Function

Morelli

Valle

Orlando

2023

Contemporary Clinical Neuroscience

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Brain-derived neurotrophic factor Val66Met and neuropsychological functioning after early childhood traumatic brain injury

Treble‐Barna

Wade

Pilipenko

et al. 2022

J Int Neuropsychol Soc

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Objective: The present study examined the differential effect of the brain-derived neurotrophic factor (BDNF) Val66Met polymorphism on neuropsychological functioning in children with traumatic brain injury (TBI) relative to orthopedic injury (OI). Methods: Participants were drawn from a prospective, longitudinal study of children who sustained a TBI (n = 69) or OI (n = 72) between 3 and 7 years of age. Children completed a battery of neuropsychological measures targeting attention, memory, and executive functions at four timepoints spanning the immediate post-acute period to 18 months post-injury. Children also completed a comparable age-appropriate battery of measures approximately 7 years post-injury. Parents rated children’s dysexecutive behaviors at all timepoints. Results: Longitudinal mixed models revealed a significant allele status × injury group interaction with a medium effect size for verbal fluency. Cross-sectional models at 7 years post-injury revealed non-significant but medium effect sizes for the allele status x injury group interaction for fluid reasoning and immediate and delayed verbal memory. Post hoc stratified analyses revealed a consistent pattern of poorer neuropsychological functioning in Met carriers relative to Val/Val homozygotes in the TBI group, with small effect sizes; the opposite trend or no appreciable effect was observed in the OI group. Conclusions: The results suggest a differential effect of the BDNF Val66Met polymorphism on verbal fluency, and possibly fluid reasoning and immediate and delayed verbal memory, in children with early TBI relative to OI. The Met allele—associated with reduced activity-dependent secretion of BDNF—may confer risk for poorer neuropsychological functioning in children with TBI.

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Epigenetic Effects on Pediatric Traumatic Brain Injury Recovery (EETR): An Observational, Prospective, Longitudinal Concurrent Cohort Study Protocol

Cited by 7 publications

References 127 publications

Operationalization of assent for research participation in pre-adolescent children: a scoping review

Operationalization of assent for research participation in pre-adolescent children: a scoping review

Epigenetics and Brain Plasticity: Back to Function

Brain-derived neurotrophic factor Val66Met and neuropsychological functioning after early childhood traumatic brain injury

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