Expanding Clinical Trials Designs to Extend Equitable Hearing Care

Patterson, Rolvix H.; Schuh, Marissa; Bush, Matthew L.; Nieman, Carrie L.; Robler, Samantha Kleindienst; Emmett, Susan D.

doi:10.1097/aud.0000000000001165

Cited by 4 publications

(6 citation statements)

References 61 publications

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“…When compared with urban populations, rural children and adults face pervasive delays in diagnosis and treatment of hearing loss (including cochlear implant care) (9,12,(26)(27)(28). Reaching vulnerable patient populations (such as rural residents) is complex, but efforts are underway through a variety of pragmatic interventional trials to improve access and timing of hearing healthcare (29)(30)(31). These types of interventions have the potential to improve the access to and timing of cochlear implantation.…”

Section: Discussionmentioning

confidence: 99%

Reporting of Sociodemographic Data in Cochlear Implant Clinical Trials: A Systematic Review

Meinhardt¹,

Sharrer²,

Perez³

et al. 2022

Otol Neurotol

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Objective: The purpose of this study was to systematically evaluate the literature on the frequency of reporting of sociodemographic data (gender, race, ethnicity, education status, health insurance status, geographic location of residence, and socioeconomic status) among interventional clinical trials involving cochlear implant patients. Databases Reviewed: A systematic search was performed in PubMed, Cochrane Database of Systematic Reviews, Web of Science, and SCOPUS to identify peer reviewed research. Methods: A systematic review was performed, which included original prospective clinical trial research studies involving cochlear implantation and/or interventional trials involving cochlear implant patients. Collected data included funding type, level of evidence, race reporting, ethnicity reporting, socioeconomic status reporting, education level reporting, type of insurance, geographic location, and gender of patients. Results: A total of 644 articles were included for review. Gender was the most reported sociodemographic factor (70% of included studies). Reporting of other data among included studies was low: educational level (6%), socioeconomic status (2%), race (1%), ethnicity (1%), insurance status (0.3%), and geography (1%). The odds of reporting gender (odds ratio [OR] = 1.51), education (OR = 1.81), and geography (OR = 2.72) increased with each subsequent publication date decade; however, this trend was not seen for reporting of race, ethnicity, socioeconomic status, or insurance. The reporting of gender was less likely to be reported in studies with the pediatric participants (OR = 0.62), level II evidence (OR = 0.14), and device programming interventional studies (OR = 0.26). Conclusion: Reporting of sociodemographic data, other than gender, is low among prospective clinical trials involving cochlear implant patients. The lack of reporting of this key data may limit research rigor and generalizability. Clinical researchers are advised to prospectively collect these data to promote equity in cochlear implant research and clinical care.

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Section: Discussionmentioning

confidence: 99%

Reporting of Sociodemographic Data in Cochlear Implant Clinical Trials: A Systematic Review

Meinhardt¹,

Sharrer²,

Perez³

et al. 2022

Otol Neurotol

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“…138 Community engagement can improve uptake and adherence of hearing services. [139][140][141] Education level, health literacy, and trust in the health care system are also factors that can influence hearing health. 134 Lower educational attainment is associated with lower hearing aid use and poorer outcomes after CI.…”

Section: Supporting Textmentioning

confidence: 99%

“…Neighborhoods without engagement between clinical teams and community members also face greater obstacles to CI 138 . Community engagement can improve uptake and adherence of hearing services 139‐141 …”

Section: Statement 3: Sociodemographic Factors and Patient Preferencesmentioning

confidence: 99%

Clinical Practice Guideline: Age‐Related Hearing Loss

Tsai Do,

Bush,

Weinreich

et al. 2024

Otolaryngol.--head neck surg.

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ObjectiveAge‐related hearing loss (ARHL) is a prevalent but often underdiagnosed and undertreated condition among individuals aged 50 and above. It is associated with various sociodemographic factors and health risks including dementia, depression, cardiovascular disease, and falls. While the causes of ARHL and its downstream effects are well defined, there is a lack of priority placed by clinicians as well as guidance regarding the identification, education, and management of this condition.PurposeThe purpose of this clinical practice guideline is to identify quality improvement opportunities and provide clinicians trustworthy, evidence‐based recommendations regarding the identification and management of ARHL. These opportunities are communicated through clear actionable statements with explanation of the support in the literature, evaluation of the quality of the evidence, and recommendations on implementation. The target patients for the guideline are any individuals aged 50 years and older. The target audience is all clinicians in all care settings. This guideline is intended to focus on evidence‐based quality improvement opportunities judged most important by the guideline development group (GDG). It is not intended to be a comprehensive, general guide regarding the management of ARHL. The statements in this guideline are not intended to limit or restrict care provided by clinicians based on their experience and assessment of individual patients.Action StatementsThe GDG made strong recommendations for the following key action statements (KASs): (KAS 4) If screening suggests hearing loss, clinicians should obtain or refer to a clinician who can obtain an audiogram. (KAS 8) Clinicians should offer, or refer to a clinician who can offer, appropriately fit amplification to patients with ARHL. (KAS 9) Clinicians should refer patients for an evaluation of cochlear implantation candidacy when patients have appropriately fit amplification and persistent hearing difficulty with poor speech understanding. The GDG made recommendations for the following KASs: (KAS 1) Clinicians should screen patients aged 50 years and older for hearing loss at the time of a health care encounter. (KAS 2) If screening suggests hearing loss, clinicians should examine the ear canal and tympanic membrane with otoscopy or refer to a clinician who can examine the ears for cerumen impaction, infection, or other abnormalities. (KAS 3) If screening suggests hearing loss, clinicians should identify sociodemographic factors and patient preferences that influence access to and utilization of hearing health care. (KAS 5) Clinicians should evaluate and treat or refer to a clinician who can evaluate and treat patients with significant asymmetric hearing loss, conductive or mixed hearing loss, or poor word recognition on diagnostic testing. (KAS 6) Clinicians should educate and counsel patients with hearing loss and their family/care partner(s) about the impact of hearing loss on their communication, safety, function, cognition, and quality of life (QOL). (KAS 7) Clinicians should counsel patients with hearing loss on communication strategies and assistive listening devices. (KAS 10) For patients with hearing loss, clinicians should assess if communication goals have been met and if there has been improvement in hearing‐related QOL at a subsequent health care encounter or within 1 year. The GDG offered the following KAS as an option: (KAS 11) Clinicians should assess hearing at least every 3 years in patients with known hearing loss or with reported concern for changes in hearing.

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“…The last two of the four papers illustrate how different methods can be used to address IDEA issues in clinicbased (Patterson et al 2022, this…”

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confidence: 99%

“…In order for hearing researchers to do a better job addressing IDEA issues, they need to understand the research methods most suited for that purpose. Patterson et al (2022, this issue, pp. 23S–32S) provides an example of the way that these research methods can be applied in clinical trials research.…”

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confidence: 99%