Over the years, multiple groups have issued recommendations for newborn hearing screening, diagnosis, and intervention. In January 2008, the US Department of Health and Human Services held an invitational workshop at which more than 50 national experts met for 2 days to consider ways to accelerate the movement of evidence-based recommendations into practice. Participants set priorities among existing recommendations, identified areas with the most promise and created a national blueprint to accelerate evidence into practice. Workshop participants adopted the “3T's Roadmap to Transform US Health Care” as the conceptual model for this work and used a modified Delphi process to identify high-priority recommendations in 5 areas (diagnosis, treatment, parental and public awareness, continuous quality improvement, and stewardship). A matrix of responsibility was developed to specify entities that could take action to implement these recommendations. Participants placed a high priority on measurement and recommended improved data-tracking of newborns after screening and creation of a limited set of national indicators to monitor progress toward evidence-based system goals. They also identified a greater role for parents and families in contributing to system transformation and a need for more culturally and linguistically appropriate resources. Targeting infants in the NICU for early testing and creating guidelines and resources for early intervention were additional priorities. Finally, the workgroup noted the need to create a stewardship function to monitor the progress of the entire system of care, disseminate reports, consider future research directions, and continue to develop critical cross-agency and public-private coordination of activities.
Many different organizations and entities have issued recommendations concerning newborn screening. The US Preventive Services Task Force recently reviewed the evidence for the benefits and possible harms of universal newborn hearing screening.1 On the basis of new research published since its last statement in 2001,2 the task force concluded that there is now sufficient evidence to recommend screening of all newborns.3 However, the reviewers recognized that improved outcomes depend not just on screening but also on effective methods of referral, follow-up, and treatment.1
The United States has been successful in implementing newborn hearing-screening programs. After pilot studies in Rhode Island in the early 1990s,4,5 screening rates rose from a baseline of <5% to 92% in 2006 and to a rate now likely exceeding 95% and continuing to rise. Only 2% of newborns do not pass their final hearing screen,6 which allays fears that high proportions of screen “referrals” could overwhelm the system. However, the subsequent steps of referral, diagnosis, and treatment have been more problematic. As discussed in other articles in this supplemental issue of Pediatrics,7,8 pediatricians in the United States have reported that they frequently lack access to screening and diagnostic test results and to information about relevant local services that limits their ability to coordinate care for infants who are deaf/hard-of-hearing (DHH) as intended in the medical home model.9,10 National data collected by the Centers for Disease Control and Prevention (CDC) suggest that more than half of the infants who do not pass their hearing screens have “no documented diagnosis.” Of those with confirmed hearing loss, one-third could not be confirmed as receiving early intervention (EI).6 Lack of agreed-on definitions for key system measures adds to the problem.11 The absence of a standard method to monitor children as they proceed through the system and to document outcomes such as language development was also cited by the US Preventive Services Task Force as contributing to the lack of good-quality US evidence to guide clinical recommendations.1
Although the task force confined its evidence review to high-quality published studies, the Joint Committee on Infant Hearing based its 2007 position statement on “best available” evidence,12 including lower categories of evidence such as expert opinion, when published studies were lacking. Clinicians who seek to improve delivery of evidence-based care to children with early hearing loss (EHL) need both stronger evidence to guide creation of clinical recommendations and a more efficient process for moving those recommendations into practice. Although the first aim can be achieved through traditional basic and clinical translational research, the second aim requires a combination of translational research, health services research, policy development, and quality improvement.
To address this gap in knowledge of how to move evidence into practice, in January 2008 the Agency for Healthcare Research and Quality (AHRQ), along with its federal partners (the CDC, the Health Resources and Services Administration–Maternal and Child Health Bureau [HRSA-MCHB], the National Institute on Deafness and Other Communication Disorders, and the Office on Disability), invited more than 50 national experts including parents and representatives of the DHH community to a 2-day workshop entitled “Accelerating Evidence-Based Recommendations Into Practice for the Benefit of Children With Early Hearing Loss.” In this article we report the conclusions and recommendations from that meeting.
The group adopted the “3T's roadmap to transform US health care”13,14 as the conceptual model for this work (see Fig 1). The term “3T's” refers to the 3 types of translational steps involved in moving research into practice: T1, the translation of basic science to clinical research; T2, clinical outcomes research coupled with the creation of practice guidelines and tools; and T3, quality-improvement strategies coupled with measurement and reporting of health care quality and costs. For successful transfer of evidence to practice, all 3 steps are important, especially T3, which has traditionally received the least attention.
To illustrate this approach, Table 1 applies the 3T's model to the process of moving cochlear implantation from research into practice. T1 and T2, the steps of basic science, clinical trials, and preliminary outcomes research, have been largely accomplished, but significant gaps remain in T3, including ensuring that the appropriate children are offered cochlear implants and that outcome measures are reported and monitored. Similar T1, T2, and T3 steps can be identified for other aspects of the system of care for children with EHL.
The workshop planning group, comprising representatives of each of the federal partners, identified sources of expert recommendations relevant to the system of care for children with EHL.7,12,24,–,26 The group concluded that, apart from certain special populations such as infants in the NICU and those birthed at home, the initial step of hearing screening had been largely successfully implemented, so the workshop focused on later steps in the process, such as rescreening, diagnosis, and intervention. The planning group identified 160 recommendations from existing reports.
Duplicate recommendations and recommendations that had already been implemented were eliminated, and the remainder were divided into 4 domains: (1) diagnosis and evaluation; (2) treatment and intervention; (3) parent resources and public awareness; and (4) program evaluation and continuous quality improvement. This final list of 130 recommendations was distributed to workshop attendees before the meeting. Participants used a modified Delphi process to identify no more than 5 recommendations in each of the 4 domains as priorities for discussion during the workshop. Each recommendation was rated on the basis of the strength of the underlying evidence and its potential impact. Participants also considered options for establishing a “stewardship” group to help guide implementation of priority recommendations and monitor progress toward improvement of the system of care for children with EHL.
Workshop participants divided into 4 groups that corresponded to the 4 system domains and used a matrix-of-responsibility tool27 to guide discussion of roles and responsibilities of stakeholders in implementing the highest-priority recommendations. The matrix-of-responsibility tool has been used in defining roles and responsibilities of service sectors in the provision of developmental services to young children.28Table 2 presents the matrix outline as used by the workshop participants. Each breakout group focused on the 2 highest-priority recommendations for their domain (Table 3). The groups then completed matrices of responsibility for implementation of each recommendation.
The workshop adopted a broad definition of health for children with EHL, “the extent to which individual children or groups of children are (a) able or enabled to develop and realize their potential, (b) satisfy their needs, and (c) develop the capacities that allow them to interact successfully with their biological, physical, and social environments.”28 Consequently, our organizing framework included educational and social interventions in addition to traditional medical treatments and management.
Prework: Selection of Priorities From Previously Recommended Steps
Table 3 shows the results of the modified Delphi process to identify the top 5 recommendations in each domain. For example, in the diagnosis-and-evaluation domain, the highest-priority recommendation was “targeted outreach to at-risk families to prevent loss to follow-up.” In the treatment-and-intervention domain, “treatment with hearing aids within 1 month of diagnosis” was selected as the top priority. Participants also ranked 4 options for the constitution of a stewardship group, and the public-private oversight body funded by the federal government ranked first.
Workshop Recommendations and Matrices of Responsibility
Results of the 4 breakout groups' discussions are shown in Tables 4 through 7. Each table shows the highest-priority recommendations identified by each breakout group, the action steps to be taken to implement the recommendations, and the actor(s) believed by the breakout group to be responsible. The following are summaries of each of the breakout groups' discussions, together with the “stewardship” discussion, for which the 3T's framework was applied with an emphasis on T3.
Diagnosis and Evaluation Group
The diagnosis and evaluation group focused on 2 areas related to the need for hearing screening, diagnosis, and referral to EI of infants in NICUs (Table 4), a specific subgroup that is at risk of late diagnosis.
Improve Screening Protocols and Diagnostic Testing Before Discharge
Infants in the NICU are at a higher risk of hearing loss, yet diagnosis and management are often delayed.3 Contributors to this problem include postponing screening because of immaturity or fragile medical status, a greater likelihood of missed screening because of hospital transfers, and a low priority for audiologic follow-up when other medical conditions require attention. Solutions lie with exploring options for earlier screening (eg, as soon as the infant's condition is stable) and improving communication between hospitals to ensure that screening is not missed in infants who transfer. Certain infants, such as very premature infants or term infants with complex medical problems who may be hospitalized for 2 to 5 months before discharge, could benefit from diagnostic audiologic testing performed in the NICU to speed diagnosis and timely treatment.3
There are specific recommendations for screening newborns who have been in the NICU longer than 5 days13 because they are at higher risk of auditory neuropathy spectrum disorder. Such infants may pass screening with otoacoustic emissions, so it is recommended that all infants cared for in the NICU for longer than 5 days be screened with automated auditory brainstem responses (AABRs). All infants who do not pass the AABRs must be referred to an audiologist for rescreening with AABRs or comprehensive diagnostic testing.
Workshop attendees concluded that work was needed to create widely accepted screening and diagnostic protocols for infants in the NICU. The group acknowledged that future technologic advances (T1) could facilitate bedside diagnostic testing in the NICU but focused their discussions on accelerating the use of existing technology. The group identified a need for the creation of clinical practice guidelines (T2) for the testing and management of infants in the NICU coupled with the creation, implementation, and validation of quality indicators (T3) (Table 4). Additional actions the group recommended were creating resources for parent-to-parent support during diagnostic testing; performing diagnostic testing in the NICU; working with audiology diagnostic centers to facilitate referrals of infants in the NICU with diagnosed hearing loss to EI while they are still inpatients; and creating Internet-based resource lists of diagnostic testing sites and primary care providers (PCPs) for use by NICU staff and parents (T3 activities).
To take responsibility for these actions, the group identified professional organizations including the American Academy of Pediatrics (AAP), the American Academy of Audiology, and the American Speech-Language-Hearing Association (Table 4). Advocacy groups could facilitate parent-to-parent support during diagnostic testing, whether performed in the NICU or after discharge. EI agencies could develop evidence-based intervention protocols for infants diagnosed with hearing loss while they are still in the NICU.
Other recommendations included having Title V agencies compile lists of centers of excellence/expertise in diagnostic testing for infants who are referred from the NICU. State programs could work with insurers (private insurers, Medicaid, Children's Health Insurance Program [CHIP]) to streamline authorizations for diagnostic testing. In addition, the CDC could monitor and report both process and outcome indicators separately for NICU graduates and infants cared for in the well-infant nursery to evaluate the impact of system improvements.
The group noted that a few hospitals currently perform diagnostic testing in the NICU and fit hearing aids before hospital discharge. They recommended that the National Center for Hearing Assessment and Management convene a workgroup of representatives from such hospitals to summarize and disseminate evidence-based best practices and provide technical assistance to other hospitals to replicate this model.
Link Infants Who Do Not Pass Screening in the NICU With a Medical Home Provider
Correct documentation of the child's main health care professional by the hospital before discharge is critical for reducing loss to follow-up and ensuring quality care. The group proposed that the AAP, the American Academy of Family Physicians, the National Association of Children's Hospitals and Research Institutions, the American Hospital Association, and the Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations [JCAHO]29) work together to create a protocol to ensure correct identification of the PCP before discharge. The group recommended conducting a nationally representative assessment of how often the PCP is known at the time of discharge and ascertaining how frequently the PCP has the results of hearing screening when seeing the newborn for follow-up. The group also recommended ongoing developmental surveillance of all infants by their PCPs to monitor for both the progress of infants diagnosed with hearing loss and late-onset losses in those infants who pass their newborn screenings.
Treatment and EI Group
The treatment and EI group focused its deliberations on 3 sets of action steps (Table 5).
Increase Timely Access to Effective EI Services
Evidence-based practice guidelines for EI programs (including traditional center- and home-based interventions as well as innovative delivery models such as teleintervention, described elsewhere in this supplemental issue30), should be developed and disseminated. Provision of unbiased information to families on choices of interventions available is also needed, as are continuous efforts to measure and improve the quality of services.
Recent evaluations of EI services, largely based on family assessments, have revealed that services are valued by families, yet there is an urgent need for experimental research to identify factors in EI that are most likely to lead to successful outcomes.31,32 The growth of neurodevelopmental and behavioral science research now presents tremendous opportunities to design innovative intervention approaches and assess their effects. More evidence of what works in EI could motivate more health care providers to screen and refer to such services.33,–,35 For example, a working group of professional associations and other interested stakeholders could create and disseminate evidence-based best-practice guidelines for intervention with young children from birth to the age of 5. These guidelines could be modeled on the National Association of State Directors of Special Education document on school-aged children who are DHH.36,37 In addition, the US Department of Education Office of Special Education and Rehabilitative Services and the MCHB could develop evidence-based training modules for preservice and in-service programs for interventionists. The National Center for Hearing Assessment and Management could collaborate with the National Early Childhood Technical Assistance Center and other organizations (eg, Marion Downs National Center, Boys Town National Research Hospital, etc) on an ongoing technical-assistance effort focused on EI services for children who are DHH. The group also recommended advocacy for increased resources for interventions by a professional alliance of all interested groups (eg, Hands and Voices, the Alexander Graham Bell Association for the Deaf and Hard of Hearing, National Association of the Deaf, American Speech-Language-Hearing Association).
Develop Initiatives to Improve Access to Loaner Hearing Aids
Infants who are newly diagnosed with DHH frequently experience delays in fitting of hearing aids while sources of funding for permanent aids are identified. Some groups have organized “loaner banks” that provide a temporary aid until a permanent aid can be obtained (see also the Limb et al38 article in this supplemental issue). Only a few states mandate coverage for hearing aids,39 and reimbursement rates vary considerably.40
Create a Systematic Process for Monitoring Developmental Outcomes
There was widespread agreement on the need for better documentation of language and communication abilities of children who are DHH (T1). Intervention providers need tools for valid assessments of early progress both in signing and oral communication skills. Providers also need tools that measure quality of life and family functioning alongside family knowledge and satisfaction with services. Measures of individual developmental progress need to be translated into local, state, and national indicators of system performance (T3). Funding is available from the National Institute on Deafness and Other Communication Disorders for such work.41,–,43
Parent Support and Public Awareness
Consumers are important contributors in shaping the health care system and as participants in their own care,44 yet they have been an underutilized resource in facilitating translation of research into practice. Families of children with EHL need formal support mechanisms at the national, state, and local levels (Table 6) that are embedded in the system and proactively offered to parents (eg, parents could request contact with other families through a checkbox added to a Health Insurance Portability and Accountability Act of 1996 [HIPAA] or Family Educational Rights and Privacy Act [FERPA] release form).
Workshop attendees recommended that advocacy groups collaborate to support a forum for key stakeholders to develop these support mechanisms and that Medicaid and CHIP programs support family-to-family resources and track data nationally on their availability, use, and functioning. Families need culturally and linguistically appropriate resources in multiple modalities, in the language of their choice, including written information, available as handouts, Web downloads, and visual media (eg, video, DVD). The group recommended that all visual media be made available in sign language and/or with captioning. Families should be offered contact with DHH role models and/or mentors that reflect the diversity of the DHH population. They should include individuals with unilateral and bilateral hearing loss from a range of cultural backgrounds who use a range of communication options. Families should decide which of these resources they wish to access to best address their individual needs.
The workgroup recommended that advocacy groups partner with the National Center for Cultural Competence45 to hold a forum on appropriate resources. In addition, the breakout group recommended that each state's Title V program identify existing resources and work with the CDC and HRSA-MCHB to distribute written and media resources via the Internet and in other family-friendly ways. State programs for children with EHL also could work with local advocacy groups to compile a comprehensive list of DHH mentors and role models and to ensure that family resource centers46,47 are equipped to provide appropriate services to families of children who are DHH.
The breakout group suggested that parents contribute to a comprehensive public awareness campaign coordinated through the HRSA-MCHB, CDC, and AHRQ to increase awareness of newborn-screening programs and the need for prompt follow-up and management. The campaign must be designed to reach all cultural and linguistic groups and draw on the expertise of established public relations and social marketing groups.
Program Evaluation, Continuous Quality Improvement, and Practice to Research
The program evaluation, continuous quality improvement, and practice to research group focused on 4 action areas.
Expand and Improve EHL Information Systems
Improving data quality and integrating information should be a high priority. Currently, the CDC is responsible for tracking and reporting aggregate data on systems related to EHL.48 In addition, the Individuals With Disabilities Education Act (IDEA) program requires reports from states on performance goals, including goals for children who are DHH.49,50 However, these data-collection efforts are not linked. Specific action steps recommended by the group (Table 7) include expansion of state data-tracking systems to allow for reporting and appropriate sharing of data. Future linkage of screening and diagnosis data with language outcomes could inform program development and facilitate the long-term follow-up that is recommended for individuals with disorders diagnosed through newborn screening.51
States could use other data-tracking systems as models such as existing state immunization registries52 or Australia's database on all individuals (including children) with hearing aids.53 The US Department of Health and Human Services Office of the National Coordinator for Health Information Technology is developing guidelines that could assist in the development of data-collection and -tracking mechanisms for newborn hearing screening and follow-up.54 Medicaid transformation grants could be a source of funding for database development.55 As reported elsewhere in this supplemental issue,56 privacy regulations such as those contained in the Health Insurance Portability and Accountability Act of 1996 and the Family Educational Rights and Privacy Act are a significant challenge that will need to be addressed in such initiatives.
Stakeholders Agree on a Locus of Responsibility for Monitoring and Tracking Care and Outcomes Data, Including Improvement Data
Currently, there is a lack of clarity on who is responsible for clinical case-tracking for Early Hearing Detection and Intervention programs. Individual states will need to determine who is responsible for this function, who will have access to the data, and how they will access the data. States will also need to determine who is responsible for reporting aggregate data, using data for quality improvement, and sharing data with other entities. Evaluation of different approaches will inform the most efficient arrangements for data-sharing.
Develop and Use a Limited Set of Agreed-on Indicators for EHL Program Structure, Process, and Outcome Indicators
An agreed-on set of structure, process, and outcome indicators57 is needed to monitor services for children with EHL for purposes of accountability and quality improvement.58,59 Some of the quality measures already available for children with special health care needs could be used to measure processes of care (eg, parent-provider communication, timeliness of care),60 but additional measures specific to children with EHL must be identified and agreed on by a consortium of advocates, providers, purchasers, policy makers, and measurement and health information technology experts.61
The breakout group recommended that the Joint Committee on Infant Hearing (JCIH) act as a coordinating entity to identify and review possible measures. Endorsement by the JCIH and other groups such the National Quality Forum62 would increase the chances of their use by important payers and service providers (eg, the Centers for Medicare & Medicaid Services).
Involve Families and Children
To ensure that children with EHL and their families benefit, families must be involved in the design, testing, and governance of information systems.63 Families also should be encouraged to take ownership of their health and information records through such new developments as personal health records.64 Optimally, personal health records should be connected to the many settings in which care is provided to children with EHL (eg, birth hospital, pediatrician's office, audiologist's office, EI services, other therapists).65,66
Numerous entities are keenly interested in working to improve care and outcomes for children with EHL.7,12,24,–,26 Workshop attendees recognized the need for a locus of responsibility to monitor progress and stimulate needed action and recommended the creation of a public-private oversight body funded and organized by the federal government. However, any formal public-private advisory group would need to comply with the Federal Advisory Committee Act of 1972 (FACA), as amended, which requires approval by the White House.
Should a stewardship group be created in either the public or private sectors, the breakout group recognized the need to build on existing collaborative efforts. The stewardship group could review information derived from system monitoring to stimulate targeted studies and spur action on the basis of evidence. A workgroup comprising representatives of the federal agencies with responsibility for services for children with EHL, family advocacy groups, and other stakeholders could assist in “closing the circle” between basic science research and clinical practice. The group could consider use of the 3T's model as a framework to guide future discussion of how to accelerate evidence into practice. The group also could receive advice from the US Secretary of Health and Human Services' Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children.51
Building on previous work,7,12,24,–,26 this workshop focused on prioritizing recommendations to improve the system of care for children with EHL, specifying clear action steps to move evidence into practice and specifically identifying those who are responsible for action. The methodology adopted at the workshop provided a useful, practical approach to moving evidence into practice. Identifying evidence-based recommendations through literature review, prioritizing recommendations with a modified Delphi process, and then identifying action steps for implementation by using a matrix of responsibility provided a practical mechanism through which to address the important question of how to improve practice.
Workshop processes were inclusive, with input from a variety of stakeholders. The varied practical experience of the participants facilitated clarification of the steps needed to transform written recommendations into actual practice. Identifying specific action steps and entities that could move implementation plans forward was frequently difficult. Many existing recommendations required further clarification. The matrix-of-responsibility exercise highlighted gaps in participant understanding of the roles of the various government agencies (eg, the CDC, MCHB, National Institutes of Health, Department of Education, and AHRQ). Even simple recommendations often required complex implementation plans that involved multiple agencies working together at the local, state, and national levels.
During this process, it was clear that the 4 facilitators of translation identified by the 3T's model (shared leadership, teamwork, tools, and resources) are all important considerations for moving recommendations into practice. Although implementation is ultimately a local activity, participants acknowledged the important role of national leadership in driving innovation. Moving any of the recommendations into practice requires teamwork across disciplines and service sectors; no single group or agency acting alone can achieve the necessary practice change.
Although participants expressed the need for increased resources for continued system improvement, policy changes that would direct resources to the system were outside the scope of this workshop. Similarly, broader policy issues influencing, for example, the proportion of young children who are uninsured were not the focus of this workshop but undoubtedly would influence the likely success of T3 efforts. Attendees identified both opportunity and openness to public-private partnerships (including families) that could drive system improvements.
More infants are being screened early for hearing loss, but the extent of essential diagnostic follow-up and treatment is variable, and there is concern that not all children are receiving the best available, evidence-based care. The outcomes of infants identified with EHL and their families can be improved by efforts to accelerate evidence into practice and to continuously monitor access, quality, and outcomes of services. Fifty participants with varying roles in improving services for children with EHL strongly endorsed a more systematic and comprehensive approach to data collection and sharing, as well as enhanced stewardship to ensure accountability and continuous quality improvement. Specific contributions of workshop participants included identification of responsible stakeholders to develop protocols for screening, diagnosis, and timely referral of infants in NICUs, develop evidence-informed guidelines and innovative approaches to EI, mount a public awareness campaign, and involve families in all aspects of early hearing detection and intervention.
The best basic research and evidence-based guidelines will not affect population health or meet the needs of families unless the final stage of translating research into practice—ensuring that the health care delivery system gets the right care to the right children at the right time—is addressed. The system of care for children with EHL has benefited from a high degree of cross-disciplinary collaboration at national, state, and local levels and is open to innovations. The transformation of health care delivery for this group of children, using approaches recommended by the workgroup, could serve as a model for broader developmental systems transformation and inform future efforts to improve delivery of all child health services.
Dr Russ was supported by AHRQ professional services contract HHSP233200800294P. The workshop was supported by AHRQ BPA contract 290-07-10046.
- Accepted May 19, 2010.
- Address correspondence to Shirley A. Russ, MD, MPH, Division of Academic Primary Care Pediatrics, 8700 Beverly Blvd, Room 1165W, Los Angeles, CA 90048. E-mail:
The opinions expressed in this article are those of the authors and do not necessarily reflect those of the US Department of Health and Human Services or its components.
FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.
- DHH =
- deaf/hard-of-hearing •
- CDC =
- Centers for Disease Control and Prevention •
- EI =
- early intervention •
- EHL =
- early hearing loss •
- AHRQ =
- Agency for Healthcare Research and Quality •
- HRSA =
- Health Resources and Services Administration •
- MCHB =
- Maternal and Child Health Bureau •
- PCP =
- primary care provider •
- AAP =
- American Academy of Pediatrics •
- CHIP =
- Children's Health Insurance Program
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