Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy (ACCL05C1): A Report From the Children's Oncology Group.

Purpose Optimal assessment methods and criteria for reporting hearing outcomes in children who receive treatment with cisplatin are uncertain. The objectives of our study were to compare different ototoxicity classification systems, to evaluate the feasibility of including otoacoustic emissions and extended high frequency audiometry, and to evaluate a central review mechanism for audiologic results for cisplatin-treated children in the cooperative group setting. Patients and Methods Eligible participants were 1 to 30 years, with planned cisplatin-containing treatment. Hearing evaluations were conducted at baseline, before each cisplatin cycle, and at the end of therapy. Audiologic results were assessed and graded by the testing audiologist and by two central review audiologists using the American Speech-Language-Hearing Association Ototoxicity Criteria (ASHA), Common Terminology Criteria for Adverse Events, version 3.0 (CTCAE), and Brock Ototoxicity Grades (Brock). One central reviewer also used the International Society of Pediatric Oncology Ototoxicity Scale (SIOP). Results At the end of treatment, the prevalence of any degree of ototoxicity ranged from 40% to 56%, and severe ototoxicity ranged from 7% to 22%. Compared with CTCAE, SIOP detected significantly more ototoxicity ( P = .004), whereas Brock criteria detected significantly fewer patients with any or severe ototoxicity ( P < .001 for both). SIOP detected ototoxicity earlier than did the other scales. Agreement between the central reviewers and the institutional audiologist was almost perfect for ASHA and Brock, whereas the poorest agreement occurred with CTCAE. Conclusion The SIOP scale may be superior to ASHA, Brock, and CTCAE scales for classifying ototoxicity in pediatric patients who were treated with cisplatin. Future studies should evaluate inter-rater reliability of the SIOP scale.

Differential ethnic associations between maternal flexibility and play sophistication in toddlers born very low birth weight.

Children born very low birth weight (<1500 g, VLBW) are at increased risk for developmental delays. Play is an important developmental outcome to the extent that child's play and social communication are related to later development of self-regulation and effective functional skills, and play serves as an important avenue of early intervention. The current study investigated associations between maternal flexibility and toddler play sophistication in Caucasian, Spanish speaking Hispanic, English speaking Hispanic, and Native American toddlers (18-22 months adjusted age) in a cross-sectional cohort of 73 toddlers born VLBW and their mothers. We found that the association between maternal flexibility and toddler play sophistication differed by ethnicity (F(3,65) = 3.34, p = .02). In particular, Spanish speaking Hispanic dyads evidenced a significant positive association between maternal flexibility and play sophistication of medium effect size. Results for Native Americans were parallel to those of Spanish speaking Hispanic dyads: the relationship between flexibility and play sophistication was positive and of small-medium effect size. Findings indicate that for Caucasians and English speaking Hispanics, flexibility evidenced a non-significant (negative and small effect size) association with toddler play sophistication. Significant follow-up contrasts revealed that the associations for Caucasian and English speaking Hispanic dyads were significantly different from those of the other two ethnic groups. Results remained unchanged after adjusting for the amount of maternal language, an index of maternal engagement and stimulation; and after adjusting for birth weight, gestational age, gender, test age, cognitive ability, as well maternal age, education, and income. Our results provide preliminary evidence that ethnicity and acculturation may mediate the association between maternal interactive behavior such as flexibility and toddler developmental outcomes, as indexed by play sophistication. Addressing these association differences is particularly important in children born VLBW because interventions targeting parent interaction strategies such as maternal flexibility must account for ethnic-cultural differences in order to promote toddler developmental outcomes through play paradigms.