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

Pragmatics development in deaf and hard of hearing children: a call to action

Although major strides have been made in supporting the linguistic development of deaf and hard of hearing (DHH) children, a high risk of pragmatic delay persists and often goes unrecognized. Pragmatic development (the growing sensitivity to one’s communication partner when producing and comprehending language in context) is fundamental to children’s social-cognitive development and to their well-being. We review the reasons why DHH children are vulnerable to pragmatic developmental challenges and the potential to create positive change. In this call to action, we then urge (1) medical providers to recognize the need to monitor for risk of pragmatic difficulty and to refer for timely intervention (beginning in infancy), (2) allied health professionals involved in supporting DHH children to incorporate development of pragmatic abilities into their work and to foster awareness among caregivers, and (3) the research community to deepen our understanding of pragmatics in DHH children with investigations that include pragmatics and with longitudinal studies that chart the paths to positive outcomes while respecting the diversity of this population. By working together, there is substantial potential to make rapid progress in lifting developmental outcomes for DHH children

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

What Factors Are Associated with Good Performance in Children with Cochlear Implants? From the Outcome of Various Language Development Tests, Research on Sensory and Communicative Disorders Project in Japan: Nagasaki Experience

ObjectivesWe conducted multi-directional language development tests as a part of the Research on Sensory and Communicative Disorders (RSVD) in Japan. This report discusses findings as well as factors that led to better results in children with severe-profound hearing loss.MethodsWe evaluated multiple language development tests in 33 Japanese children with cochlear implants (32 patients) and hearing aid (1 patient), including 1) Test for question and answer interaction development, 2) Word fluency test, 3) Japanese version of the Peabody picture vocabulary test-revised, 4) The standardized comprehension test of abstract words, 5) The screening test of reading and writing for Japanese primary school children, 6) The syntactic processing test of aphasia, 7) Criterion-referenced testing (CRT) for Japanese language and mathematics, 8) Pervasive development disorders ASJ rating scales, and 9) Raven's colored progressive matrices. Furthermore, we investigated the factors believed to account for the better performances in these tests. The first group, group A, consisted of 14 children with higher scores in all tests than the national average for children with hearing difficulty. The second group, group B, included 19 children that scored below the national average in any of the tests.ResultsOverall, the results show that 76.2% of the scores obtained by the children in these tests exceeded the national average scores of children with hearing difficulty. The children who finished above average on all tests had undergone a longer period of regular habilitation in our rehabilitation center, had their implants earlier in life, were exposed to more auditory verbal/oral communication in their education at affiliated institutions, and were more likely to have been integrated in a regular kindergarten before moving on to elementary school.ConclusionIn this study, we suggest that taking the above four factors into consideration will have an affect on the language development of children with severe-profound hearing loss

Longitudinal Study on Trace Mineral Compositions (Selenium, Zinc, Copper, Manganese) in Korean Human Preterm Milk

We measured selenium, zinc, copper and manganese concentrations in the human milk of Korean mothers who gave birth to preterm infants, and compared these measurements with the recommended daily intakes. The samples of human milk were collected postpartum at week-1, -2, -4, -6, -8, and -12, from 67 mothers who gave birth to preterm infants (< 34 weeks, or birth weight < 1.8 kg). All samples were analyzed using atomic absorption spectrophotometry. The concentrations of selenium were 11.8 ± 0.5, 11.4 ± 0.8, 12.7 ± 0.9, 11.4 ± 0.8, 10.8 ± 0.9, and 10.5 ± 1.3 µg/L, zinc were 7.8 ± 0.5, 9.1 ± 0.8, 7.2 ± 0.9, 8.0 ± 0.8, 7.4 ± 0.9, and 6.6 ± 1.2 mg/L, copper were 506 ± 23.6, 489 ± 29.4, 384 ± 33.6, 356 ± 32.9, 303 ± 35.0, and 301 ± 48.0 µg/L and manganese were 133 ± 4.0, 127 ± 6.0, 125 ± 6.0, 123 ± 6.0, 127 ± 6.0, and 108 ± 9.0 µg/L at week-1, -2, -4, -6, -8, and -12, respectively. The concentrations of selenium and zinc meet the daily requirements but that of copper is low and of manganese exceeds daily requirements recommended by the American Academy of Pediatrics, Committee on Nutrition

Prevalence and risk factors for vitamin D deficiency in children with iron deficiency anemia

PurposeThe increasing prevalence of breast feeding has led to concerns about vitamin D deficiency (VDD) and iron deficiency anemia (IDA) in children. We evaluated the prevalence of VDD in a population of Korean children with IDA and assessed the risk factors for VDD in these children.MethodsA total of 79 children who were diagnosed with IDA were prospectively surveyed from April 2010 to March 2011. Data were collected by questionnaire, medical assessment, and laboratory tests, including measurement of 25-hydroxyvitamin D (25OHD), hemoglobin, and wrist radiography.ResultsThe median age was 22 months and 30% of the subjects were female. Over a half of subjects (58%) had subnormal vitamin D level (25OHD<30 ng/mL), and VDD (25OHD<20 ng/mL) was present in 39% of children. There was no difference in serum hemoglobin level between IDA patients with VDD and those without VDD. Most subjects (89%) were currently or had recently been breastfed and almost all subjects (97%) who had VDD received breastfeeding. Children with VDD were more likely to be younger than 2 years, to have been breastfed, and to have been tested in winter or spring. Multivariable analysis indicated seasonal variation was a significant independent risk factor for VDD in our IDA patients.ConclusionOur results demonstrated that VDD has a high prevalence in Korean children with IDA. Primary care physicians should be aware of the possibility of VDD in children with IDA and should supplement the vitamin D as well as iron

Comparison of Different Hearing Aid Prescriptions for Children.

OBJECTIVES: To assess whether there are significant differences between speech scores for different hearing aid prescription methods, specifically DSL i/o, DSL V, and NAL-NL1, using age-appropriate closed- and open-set speech tests with young children, designed to avoid floor and ceiling effects. DESIGN: Participants were 44 children with moderate or severe bilateral hearing loss, 8 aged 2 to 3 years, 15 aged 4 to 5 years, and 21 aged 6 to 9 years. Children wore bilateral hearing aids fitted with each prescription method in turn in a balanced double-blind design. The speech tests used with each child (and for some tests the levels) were chosen so as to avoid floor and ceiling effects. For the closed-set tests, the level used was selected for each child based on their hearing loss. The tests used were: (1) The closed-set Consonant Confusion Test of word identification; (2) The closed-set Chear Auditory Perception Test (CAPT) of word identification. This has separate sections assessing discrimination of consonants and vowels and detection of consonants; (3) The open-set Cambridge Auditory Word Lists for testing word identification at levels of 50 and 65 dBA, utilizing 10 consonant-vowel-consonant real words that are likely to be familiar to children aged 3 years or older; (4) The open-set Common Phrases Test to measure the speech reception threshold in quiet; (5) Measurement of the levels required for identification of the Ling 5 sounds, using a recording of the sounds made at the University of Western Ontario. RESULTS: Scores for the Consonant Confusion Test and CAPT consonant discrimination and consonant detection were lower for the NAL-NL1 prescription than for the DSL prescriptions. Scores for the CAPT vowel-in-noise discrimination test were higher for DSL V than for either of the other prescriptions. Scores for the Cambridge Auditory Word Lists did not differ across prescriptions for the level of 65 dBA, but were lower for the NAL-NL1 prescription than for either of the DSL prescriptions for the level of 50 dBA. The speech reception threshold measured using the Common Phrases Test and the levels required for identification of the Ling 5 sounds were higher (worse) for the NAL-NL1 prescription than for the DSL prescriptions. CONCLUSIONS: The higher gains prescribed by the DSL i/o and DSL V prescription methods relative to NAL-NL1 led to significantly better detection and discrimination of low-level speech sounds.We thank Deafness Research UK (now part of Action on Hearing Loss) for funding, Phonak and Oticon for the study hearing aids, PC Werth and Audioscan for the Verifit system, John Deeks for help with calibration, the children and their families, and the audiology host centers