05-19880. Proposed Data Collections Submitted for Public Comment and Recommendations

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Proposed Project

Assessment of State Early Hearing Detection and Intervention Programs (EHDI): A Program Operations Evaluation Protocol—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC).

Background and Brief Description: Every year, an estimated 12,000 newborns are diagnosed with permanent hearing loss, a condition that if not identified and treated early can lead to impaired functioning and development. CDC's role in the detection, diagnosis, and treatment of early hearing loss through the “Early Hearing Detection and Intervention Program” (EHDI) is of vital importance for families of newborns and infants affected by hearing loss. Nonetheless, recent data indicate that only 60 percent of the newborns that fail hearing screening are evaluated by the recommended 3 months of age.

The evaluation will involve an integrative evaluation approach that encompasses the following activities, conducted in Arkansas, Massachusetts, Michigan, Utah, and Virginia: (1) A 10-minute survey of 3,000 mothers whose newborns have been screened (the “Maternal Exit Survey”); and (2) a 20-minute computer-assisted telephone interviewing (CATI) survey of 1,000 mothers of newborns who have been referred for additional hearing evaluation (the “Maternal CATI Interview.”) To complete these interviews, it is expected that 5,000 will be contacted. The overall burden on all contacted women is expected to be approximately 940 hours. The Maternal Exit Survey and the Maternal CATI Interview will address the following research questions: (1) What are the factors that impede or enable families to follow-up for early hearing evaluation and intervention; (2) What EHDI strategies implemented by hospitals appear to be most successful in reducing loss to follow-up; and (3) Is loss to follow-up associated with maternal characteristics such as parity, age or ethnicity? Both surveys will be available in English and Spanish.

Hearing loss is the most common disorder that can be detected through newborn screening programs. Prior to the implementation of newborn hearing screening, children with hearing loss typically were not identified until 2 to 3 years of age. This is well beyond the period of early language development. Now, with comprehensive EHDI programs, the average age of identification of children with hearing loss has been reduced so that it is now possible to provide interventions for children younger than one year of age. With early identification, children with hearing loss can begin receiving appropriate intervention services that provide the best opportunity for these children to reach their maximum potential in such areas as language, communication, social and emotional development, and school achievement.

Newborn hearing screening is only the first step in the identification of children with hearing loss. Children who do not pass their screening need to be further evaluated to determine if they have hearing loss. The value of newborn hearing screening cannot be realized unless children complete the screening, evaluation, and intervention process. Since recent data indicate that nearly 40 percent of children do not complete the evaluation-intervention process, this project is designed to understand what barriers exist in following through with evaluation and intervention. This evaluation also plans to provide data necessary to develop innovative solutions that can be applied by states, hospitals, and local programs. Results from this collection have the potential to strengthen the EHDI process and minimize social and economic disability among persons born with hearing loss.

By evaluating the policy, structural, personal, and financial factors and barriers associated with loss to follow-up in the EHDI program, this study seeks to identify “best practices” for improving detection, referral to evaluation and intervention, and adherence to intervention. CDC's plan to publish data and results from this evaluation will help state health officials, other Federal agencies, and other stakeholders to improve the EHDI process-providing direct benefit to infants with hearing loss and their families. The total estimated burden hours are 940.

Estimated Annualized Total Burden Hours

Instrument	Number of respondents	Responses per respondent	Average burden per response (in hrs.)
Maternal Exit Survey
Request to Participate	3,750	1	1/60
Complete Survey	3,000	1	10/60
Maternal CATI Interview
Request to Participate	1,250	1	2/60
Consent and Screening, but no Hearing Test	8	1	1/60
Consent and Partially Completed Screening, Hearing Test but no Results	8	1	15/60
Consent and Completed Interview	1,000	1	20/60

Dated: September 28, 2005.

Betsey Dunaway,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.