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Published on: December 6, 2016
Patient-Stakeholder Engagement for Patient-Centered Research on Sleep Apnea
Sairam Parthasarathy1,2, Gilles Frydman3
1University of Arizona Center for Sleep, Circadian, and Neuroscience Research, University of Arizona, Tucson.
Abstract:
AbstractIn 2016, many clinicians and investigators in the field of sleep apnea were surprised when a large multinational clinical trial of continuous positive airway pressure (CPAP) therapy failed to demonstrate a reduction in cardiovascular events in patients with sleep apnea and established cardiovascular disease. When a review of the trial data suggested that CPAP nonadherence among trial participants might explain the negative results, it became clear that new approaches were needed. In this Clinical Trials Case Study, we share our experience designing a trial to evaluate a peer-support strategy to improve CPAP adherence. We address how patients were the drivers of research ideas and discuss how the return on investment in such patient-engaged approaches to research can be high for patients, trialists, and, ultimately, public health. Our experience could serve as a road map for investigators who have the same trepidation as we once did to create, engage, and empower a patient-stakeholder committee. Such knowledge could help clinical trials accomplish the stated goals for various chronic medical conditions.
Insights
Patient-led research can improve adherence to continuous positive airway pressure (CPAP) therapy for sleep apnea. Engaging patients in trial design enhances research outcomes and public health benefits.
Area of Science:
- Sleep Medicine
- Clinical Trials
- Cardiovascular Disease
Background:
- A 2016 trial found continuous positive airway pressure (CPAP) did not reduce cardiovascular events in sleep apnea patients.
- CPAP nonadherence was suspected as a reason for the trial's negative results, highlighting a need for new strategies.
Purpose of the Study:
- To describe the design of a clinical trial evaluating a peer-support strategy for improving CPAP adherence.
- To emphasize the role of patients as drivers of research ideas and their impact on trial success.
Main Methods:
- The study details the design of a clinical trial focused on a peer-support intervention.
- Patient-stakeholder committees were integral to the research process, guiding trial development.
Main Results:
- Patient engagement in research design can yield significant returns on investment.
- This patient-centered approach can help clinical trials achieve their objectives for chronic conditions.
Conclusions:
- Empowering patients in clinical trial design is crucial for addressing challenges like CPAP nonadherence.
- Patient-engaged research offers a roadmap for improving trial success and public health outcomes in sleep apnea and other chronic diseases.
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