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Past Opportunities to Provide Input
- Patient-Centered Economic Outcomes Landscape (2023-2024)
- Systematic Review of Audio Care for the Management of Mental Health and Chronic Conditions (2023) -- Draft Key Questions
- Proposed New Methodology Standards for Usual Care as a Comparator (2023)
- Stakeholder Views on Components of 'Patient-Centered Value' in Health and Health Care (2023)
- PCORI's Proposed Research Agenda (2021-2022)
- Proposed National Priorities for Health (2021)
- Proposed Principles for the Consideration of the Full Range of Outcomes Data in PCORI-Funded Research (2020)
- Proposed New PCORI Methodology Standards (2018)
- Data Access and Data Sharing Policy: Public Comment (2017)
- Proposed New PCORI Methodology Standards (2017)
Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
- 1. Standards for Formulating Research Questions
- 10: Standards for Studies of Diagnostic Tests
- 12. Standards on Research Designs Using Clusters
- 13: General Comments on the Proposed Revisions to the PCORI Methodology Standards
- 2: Standards Associated with Patient-Centeredness
- 3: Standards for Data Integrity and Rigorous Analysis
- 4: Standards for Preventing and Handling Missing Data
- 5: Standards for Heterogeneity of Treatment Effects
- 6: Standards for Data Registries
- 7: Standards for Data Networks as Research-Facilitating Structures
- 8. Standards for Causal Inference Methods
- 9. Standards for Adaptive Trial Designs
- Peer-Review Process Comments (2014)
- Draft Methodology Report Public Comment Period (2012)
- Past Opportunities to Provide Input
In 2019, PCORI issued a call for research proposals to help address the highly prevalent, but often undertreated, condition of age-related hearing loss. Sherri Smith, AuD, PhD, Associate Professor of Head and Neck Surgery and Communication Sciences at Duke University School of Medicine, was inspired to respond to this PCORI Funding Announcement to help address clinical dilemmas and answer what she describes as the "challenging questions that we hear patients ask in clinic."
Smith is an audiologist by training with a doctorate in audiology and communication sciences. Her experiences with a close family member who had hearing loss led her to the field. Her research focus is on addressing hearing loss in older adults and comparing interventions to improve their hearing health. Smith believes “hearing loss may be a biomarker for our overall health,” and is especially interested in the interplay between hearing loss and other chronic medical conditions.
Two…Better than One?
In 2020, Smith was awarded PCORI funding to study whether two hearing aids are better than one in adults ages 50 years and older with bilateral, mild-to-moderate hearing loss. Smith notes that for most people, bilateral hearing aids provide better outcomes than a unilateral device. Little is known, however, about outcomes among people with milder degrees of hearing loss, Smith adds, and there may be a subpopulation of people that does better with or prefers a unilateral hearing aid.
Smith and her team hope to bridge this gap in the literature and are currently enrolling 350 patients from two clinics in North Carolina and Tennessee into a clinical trial. Patients using hearing aids for the first time will be randomized to receive either one hearing aid or two. Participants will undergo hearing evaluation prior to the start of the study and then again at 3 months after being fitted for hearing aids. They will also complete surveys before and during the study about their hearing-related quality of life.
Hearing loss may be a biomarker for our overall health.Sherri Smith, AuD, PhD PCORI-funded Principal Investigator
At the end of the trial, patients in the two groups will have the option to crossover and change the number of hearing aids they use. Patients will purchase their own hearing aids and if they choose, can return their devices for a refund at the end of the trial. Smith feels the study design reflects actual clinical scenarios and will help her team answer “real-world, patient-driven questions.” Study participants will be invited to join focus groups to discuss their experiences as well. Smith hopes to understand which factors might prompt people to use one versus two hearing aids. Patients’ perceptions of benefit associated with wearing hearing aid(s), device cost, and device comfort may all play a role, Smith notes.
Hearing Healthcare Journey
Through her research, Smith wants to understand more fully how patients with hearing loss “are experiencing their healthcare journey.” By evaluating their unique health needs, she intends to help them “achieve their optimal outcomes.” She also notes that “hearing loss needs to be prioritized during healthcare encounters,” especially because enhanced communication means a more positive encounter for both patients and their providers. Her hope is that her research and other patient-centered studies will ultimately help “integrate hearing care into health care.”