Who Speaks for Me?: Addressing Variability in Informed Consent Practices for Minimal Risk Research Involving Foster Youth

Background: Youth in protective custody (i.e., foster care) are at higher risk for poorer physical and mental health outcomes compared with those who are not. These differences may be due in part to the lack of research on the population to create evidence-based recommendations for health care delivery. A potential contributor to this lack of research is difficulties in obtaining informed consent for empirical studies in this population. The objective of this study was to describe the approaches to obtaining informed consent in minimal risk studies of foster youth and provide recommendations for future requirements. Methods: We conducted a systematic review of the literature to characterize the informed consent approaches in published minimal risk research involving youth in foster care. We searched PubMed, CINAHL, PsychINFO, Embase, ERIC, Scopus, and EBMR. Inclusion criteria were: studies conducted in the United States, included current foster youth, minimal risk, peer reviewed, and published in English. Full text was reviewed, and individuals required to consent and assent were extracted. Results: Forty-nine publications from 33 studies were identified. Studies required 0 to 3 individuals to consent. Individuals required to give consent included case workers (16, 48%), foster caregivers (12, 36%), biological parents (7, 21%), judges (5, 15%), and guardian ad litems (2, 6%). Twenty-nine (88%) studies required the youth’s assent. The studies used 14 different combinations of individuals. One (3%) study utilized a waiver of consent. Conclusions: There is no consistent approach for obtaining informed consent for foster youth to participate in minimal risk research. Consent should ideally involve individuals with legal authority and knowledge of the individual youth’s interests and should not be burdensome. Consensus regarding consent requirements may facilitate research involving foster youth

Patterned feeding experience for preterm infants: study protocol for a randomized controlled trial

Background Neurobehavioral disabilities occur in 5–15 % of preterm infants with an estimated 50–70 % of very low birth weight preterm infants experiencing later dysfunction, including cognitive, behavioral, and social delays that often persist into adulthood. Factors implicated in poor neurobehavioral and developmental outcomes are hospitalization in the neonatal intensive care unit (NICU) and inconsistent caregiving patterns. Although much underlying brain damage occurs in utero or shortly after birth, neuroprotective strategies can stop lesions from progressing, particularly when these strategies are used during the most sensitive periods of neural plasticity occurring months before term age. The purpose of this randomized trial is to test the effect of a patterned feeding experience on preterm infants’ neurobehavioral organization and development, cognitive function, and clinical outcomes. Methods This trial uses an experimental, longitudinal, 2-group design with 120 preterm infants. Infants are enrolled within the first week of life and randomized to an experimental group receiving a patterned feeding experience from the first gavage feeding through discharge or to a control group receiving usual feeding care experience. The intervention involves a continuity of tactile experiences associated with feeding to train and build neuronal networks supportive of normal infant feeding experience. Primary outcomes are neurobehavioral organization as measured by Neurobehavioral Assessment of the Preterm Infant at 3 time points: the transition to oral feedings, NICU discharge, and 2 months corrected age. Secondary aims are cognitive function measured using the Bayley Scales of Infant and Toddler Development, Third Edition at 6 months corrected age, neurobehavioral development (sucking organization, feeding performance, and heart rate variability), and clinical outcomes (length of NICU stay and time to full oral feeding). The potential effects of demographic and biobehavioral factors (perinatal events and conditions of maternal or fetal/newborn origin and immunologic and genetic biomarkers) on the outcome variables will also be considered. Discussion Theoretically, the intervention provided at a critical time in neurologic system development and associated with a recurring event (feeding) should enhance neural connections that may be important for later development, particularly language and other cognitive and neurobehavioral organization skills

Sociodemographic characteristics and patient and family experience survey response biases

Enhancing Patient and Family Experience (PFE) is vital to the delivery of quality healthcare services. Sociodemographic differences affect health outcomes and experiences, but research is limited on biases in PFE survey methodology. We sought to assess survey participation rates across sociodemographic characteristics. This retrospective study analyzed a health system’s ambulatory PFE survey data, collected January 1 – July 31, 2019. Outcomes of interest were rates of survey response, completion, and comments. Predictors included respondent-reported race, ethnicity, language, and measure of social deprivation attached to a respondent’s home address. Addresses were geocoded to census tracts. The tract’s degree of socioeconomic deprivation was defined using the Deprivation Index (DPI). Associations between outcomes and predictors were assessed using the Chi square test. 77,627 unique patient encounters were analyzed. Patients were predominantly White (76%); 5% were Hispanic; and 1% were Spanish-speaking. The overall response, completion, and comment rates were 20.1%, 17.6%, and 4.1%, respectively. There were significant differences across assessed sociodemographic characteristics in response, completion, and comment rates. White patients were most likely to respond, complete, and leave a comment. Spanish-speaking respondents and those living in the most deprived areas were more likely to respond and complete the survey, but less likely to comment than English-speaking respondents and those living in less deprived areas, respectively. PFE survey participation differs across a range of sociodemographic characteristics, potentially introducing noteworthy biases. Health systems should minimize differences in how they collect feedback and account for potential biases when responding to experience data. Experience Framework This article is associated with the Policy & Measurement lens of The Beryl Institute Experience Framework. (https://www.theberylinstitute.org/ExperienceFramework). Access other PXJ articles related to this lens. Access other resources related to this lens

Development of a State-Wide Database of Early Intervention and Educational Outcomes for Children who are Deaf/Hard of Hearing

Children who are born deaf/hard of hearing (D/HH) are at increased risk for delays in language, cognitive and social-emotional development. Early identification through screening and early intervention (EI) can improve outcomes for children who are D/HH. However, a need remains to evaluate the effectiveness and practices of statewide programs for children who are D/HH. The Ohio EHDI Data Linkage Project was created as a state-wide collaborative that included multiple Ohio government agencies and an academic institution. The objective of the project was to develop and characterize population-based, longitudinal database that documents state-level services and outcomes for children who are D/HH identified through a state EHDI Program. The database includes information regarding birth data, EHDI program data, early intervention data, and early academic data. Children born in Ohio between 2008 and 2014 identified with permanent hearing loss (n=1746) served as the cohort for this project; 1262 records linked with EI data and 502 records linked with education data. Multi-agency linked databases contain novel combinations of data and can be valuable resources for public health evaluative and epidemiologic research. This resource can expand our understanding of the early predictors of academic success for children who are D/HH

Familial Autoimmune Thyroid Disease as a Risk Factor for Regression in Children with Autism Spectrum Disorder: A CPEA Study

A multicenter study of 308 children with Autism Spectrum Disorder (ASD) was conducted through the Collaborative Programs of Excellence in Autism (CPEA), sponsored by the National Institute of Child Health and Human Development, to compare the family history of autoimmune disorders in children with ASD with and without a history of regression. A history of regression was determined from the results of the Autism Diagnostic Interview-Revised (ADI-R). Family history of autoimmune disorders was obtained by telephone interview. Regression was significantly associated with a family history of autoimmune disorders (adjusted OR=1.89; 95% CI: 1.17, 3.10). The only specific autoimmune disorder found to be associated with regression was autoimmune thyroid disease (adjusted OR=2.09; 95% CI: 1.28, 3.41).Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/43035/1/10803_2005_Article_71.pd

Selective elimination of cerebellar output in the genetically dystonic rat

The genetically dystonic (dt) rat, an autosomal recessive mutant, exhibits a progressive motor syndrome that resembles the generalized idiopathic dystonia seen in humans. Even with supportive measures,dt rats die before reaching maturity. A total cerebellectomy that includes the dorsal portions of the lateral vestibular nuclei (dLV) eliminates the dystonic motor syndrome of thedt rats, greatly improves motor function, and prevents early death. The selective elimination of cerebellar nuclei was used to determine the cerebellar components critical to the mutant\u27s motor syndrome. Bilateral electrolytic and/or excitatory amino acid lesions of the medial cerebellar nucleus, nucleus interpositus, lateral cerebellar nucleus and dLV were created in separate groups of 15-day-olddt rats. Rats were observed for the presence of abnormal motor signs (falls, twists, clasps, pivots) and tested on several measures of motor performance (activity, climbing, righting, homing, hanging) before surgery and again on Postnatal Day 20. All nuclear lesions produced significant improvements in motor function and decreases in the frequency of abnormal motor signs. Electrolytic lesions of the dLV were associated with the greatest improvements. © 1995 Elsevier Science B.V. All rights reserved

Impact of Global Health Education on Pediatric Residency Applicants' Rank-List and Decision Process

Abstract Background: The globalization of healthcare has contributed to a rapid increase in global health education (GHE) among residency programs. However the impact of GHE on pediatric residency selection and potential barriers to GHE have not been reported