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Hearing Norton Sound: a community randomised trial protocol to address childhood hearing loss in rural Alaska.

ABSTRACT: INTRODUCTION:The population in rural Alaska experiences a disproprionately high burden of infection-mediated hearing loss. While the state mandates school hearing screening, many children with hearing loss are not identified or are lost to follow-up before ever receiving treatment. A robust, tribally owned healthcare system exists in Alaska, but children with hearing loss must first be identified and referred for existing infrastructure to be used. This trial will evaluate a new school hearing screening and referral process in rural Alaska, with the goal of improving timely identification and treatment of childhood hearing loss. METHODS AND ANALYSIS:Comparative effectiveness community randomised trial testing digital innovations to improve school hearing screening and referral in 15 communities in the Norton Sound region of northwest Alaska, with data collection from October 2017 to February 2020. All children (K-12) attending school in Bering Strait School District with parental informed consent and child assent will be eligible (target recruitment n=1500). Participating children will undergo both the current school hearing screen and new mobile health (mHealth) screen, with screening test validity evaluated against an audiometric assessment. Communities will be cluster randomised to continue the current primary care referral process or receive telemedicine referral for follow-up diagnosis and treatment. The primary outcome will be time to International Statistical Classification of Diseases, 10th Revision, ear/hearing diagnosis from screening date, measured in days. Secondary outcomes will include: sensitivity and specificity of current school and mHealth screening protocols measured against a benchmark audiometric assessment (air and bone conduction audiometry, tympanometry and digital otoscopy); hearing loss prevalence; hearing-related quality of life; and school performance (AIMSweb). Intention-to-treat analysis will be used. ETHICS AND DISSEMINATION:This study has been approved by the Institutional Review Boards of Alaska Area, Norton Sound and Duke University and is registered on clinicaltrials.gov. Results will be distributed with equal emphasis on scientific and community dissemination. TRIAL REGISTRATION NUMBER:NCT03309553; Pre-results.

SUBMITTER: Emmett SD

PROVIDER: S-EPMC6340015 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Hearing Norton Sound: a community randomised trial protocol to address childhood hearing loss in rural Alaska.

Emmett Susan D SD Robler Samantha Kleindienst SK Wang Nae-Yuh NY Labrique Alain A Gallo Joseph J JJ Hofstetter Philip P

BMJ open 20190115 1

<h4>Introduction</h4>The population in rural Alaska experiences a disproprionately high burden of infection-mediated hearing loss. While the state mandates school hearing screening, many children with hearing loss are not identified or are lost to follow-up before ever receiving treatment. A robust, tribally owned healthcare system exists in Alaska, but children with hearing loss must first be identified and referred for existing infrastructure to be used. This trial will evaluate a new school h ...[more]

PMID: 30782695

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Project description:IntroductionChildhood hearing loss has implications for school achievement, economic outcomes and quality of life. This study will engage rural Alaska communities in research to improve the school hearing screening and referral process, partnering with stakeholders to develop a locally derived, evidence-based solution to improve timely identification and treatment of childhood hearing loss.Methods and analysisMixed methods community randomised trial in 15 communities in the Norton Sound region of northwest Alaska. Data collection will span from April 2017 until February 2020. Qualitative and mixed methods components are described in this protocol and the community randomised trial in the companion protocol. Focus groups and community events will be held leading up to the randomised trial to obtain community perspectives on childhood hearing loss in Alaska and elicit community input during trial protocol refinement (exploratory sequential stage). Stakeholder groups, including parents, children, teachers, school administrators and community health aides, will participate, along with community leaders, tribal leaders and community members. The randomised trial will be combined with qualitative, semi-structured interviews to elicit stakeholder perspectives on the intervention (explanatory sequential stage). The five stakeholder groups described above will participate in interviews. The study will conclude with additional focus groups and community events to discuss results and provide community insight for future implementation. Concluding focus groups will include policymakers, healthcare administrators, and tribal and community leaders in addition to the stakeholder groups. Informed consent and child assent will be required. Recordings will be transcribed and deidentified, with only stakeholder group recorded. Analyses will include categorical coding as well as narrative and thematic analysis.Ethics and disseminationThe Hearing Norton Sound study has been approved by the Institutional Review Boards of Alaska Area, Norton Sound, and Duke University, with trial registration on clinicaltrials.gov. Study results will be distributed with equal emphasis on scientific and community dissemination.Trial registration numberNCT03309553; Results.

Project description:ObjectivesChildhood hearing loss has well-known lifelong consequences. Certain rural populations are at higher risk for infection-related hearing loss. For Alaska Native children, historical data on hearing loss prevalence suggest a higher burden of infection-related hearing loss, but updated prevalence data are urgently needed in this high-risk population.DesignHearing data were collected as part of two school-based cluster-randomized trials in 15 communities in rural northwest Alaska over two academic years (2017-2019). All enrolled children from preschool to 12th grade were eligible. Pure-tone thresholds were obtained using standard audiometry and conditioned play when indicated. The analysis included the first available audiometric assessment for each child (n = 1634 participants, 3 to 21 years), except for the high-frequency analysis, which was limited to year 2 when higher frequencies were collected. Multiple imputation was used to quantify the prevalence of hearing loss in younger children, where missing data were more frequent due to the need for behavioral responses. Hearing loss in either ear was evaluated using both the former World Health Organization (WHO) definition (pure-tone average [PTA] > 25 dB) and the new WHO definition (PTA ≥ 20 dB), which was published after the study. Analyses with the new definition were limited to children 7 years and older due to incomplete data obtained on younger children at lower thresholds.ResultsThe overall prevalence of hearing loss (PTA > 25 dB; 0.5, 1, 2, 4 kHz) was 10.5% (95% confidence interval [CI], 8.9 to 12.1). Hearing loss was predominately mild (PTA >25 to 40 dB; 8.9%, 95% CI, 7.4 to 10.5). The prevalence of unilateral hearing loss was 7.7% (95% CI, 6.3 to 9.0). Conductive hearing loss (air-bone gap of ≥ 10 dB) was the most common hearing loss type (9.1%, 95% CI, 7.6 to 10.7). Stratified by age, hearing loss (PTA >25 dB) was more common in children 3 to 6 years (14.9%, 95% CI, 11.4 to 18.5) compared to children 7 years and older (8.7%, 95% CI, 7.1 to 10.4). In children 7 years and older, the new WHO definition increased the prevalence of hearing loss to 23.4% (95% CI, 21.0 to 25.8) compared to the former definition (8.7%, 95% CI, 7.1 to 10.4). Middle ear disease prevalence was 17.6% (95% CI, 15.7 to 19.4) and was higher in younger children (23.6%, 95% CI, 19.7 to 27.6) compared to older children (15.2%, 95% CI, 13.2 to 17.3). High-frequency hearing loss (4, 6, 8kHz) was present in 20.5% (95% CI, 18.4 to 22.7 [PTA >25 dB]) of all children and 22.8% (95% CI, 20.3 to 25.3 [PTA >25 dB]) and 29.7% (95% CI, 27.0 to 32.4 [PTA ≥ 20 dB]) of children 7 years and older (limited to year 2).ConclusionsThis analysis represents the first prevalence study on childhood hearing loss in Alaska in over 60 years and is the largest cohort with hearing data ever collected in rural Alaska. Our results highlight that hearing loss continues to be common in rural Alaska Native children, with middle ear disease more prevalent in younger children and high-frequency hearing loss more prevalent with increasing age. Prevention efforts may benefit from managing hearing loss type by age. Lastly, continued research is needed on the impact of the new WHO definition of hearing loss on field studies.

Project description:Community involvement is important in good research practice. We led a community-based study to improve early detection and treatment of childhood hearing loss in rural Alaska. This study evaluated a cell phone-based hearing screening process and compared a new telemedicine specialty referral pathway to the standard primary care referral pathway. The study included community involvement, engagement, and participation from the very beginning to inform how to best design the trial. We obtained insight and feedback from community members through involvement of a core stakeholder team and through community engagement and participation in focus groups and community events. Feedback received through community involvement and participation influenced the design of the trial at key decision points. Community member guidance shaped the research question, the outcomes to be measured, and the procedures for completing the project, such as participant recruitment. This study offers an example of community involvement, engagement and participation that could be mirrored in future research to maintain the interests of participating communities. Background Effective systems for early identification and treatment of childhood hearing loss are essential in rural Alaska, where data indicate a high prevalence of childhood ear infections and hearing loss. However, loss to follow-up from school hearing screening programs is pervasive. The Hearing Norton Sound study was a mixed methods community randomized controlled trial that was developed to address this gap. The study engaged community members and participants in the design of the trial, including involvement of stakeholders as collaborators. Methods Community engagement and participation in research design occurred through focus groups and through the integration of stakeholders into the study team. Representation was cross-sectoral, involving individuals from multiple levels of the school and health system, as well as community members from each of the 15 communities. Feedback obtained between April 2017 and August 2017 informed the final design of the randomized trial, which began enrollment of children in October 2017 and concluded in March 2019. Results Stakeholder involvement and community participation shaped the design of specific trial elements (research question; comparators; outcomes and measures; telemedicine protocols; and recruitment and retention). Community involvement was strengthened by the use of multiple modalities of involvement and by the positionality of lead stakeholders on the study team. Conclusions This study highlights the effectiveness of multifaceted stakeholder involvement and participation in the design of health research conducted within Alaska Native communities. It offers an example of involvement and reporting that could be mirrored in future research in order to protect and further the interests of the participating community. Trial registration ClinicalTrials.gov, NCT03309553 , First registered 10/9/2017.

Dataset Information

Hearing Norton Sound: a community randomised trial protocol to address childhood hearing loss in rural Alaska.

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Hearing Norton Sound: a community randomised trial protocol to address childhood hearing loss in rural Alaska.

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