(Press-News.org) DARIEN, IL - The American Academy of Sleep Medicine has developed and validated a patient-reported outcome tool for use in a clinical setting to monitor treatment response and longitudinal symptom progression in adults who have obstructive sleep apnea.
Results show that the “Patient-reported Longitudinal Assessment Tool for OSA” demonstrates strong internal consistency and test-retest reliability, and it exhibits robust construct validity through moderate-to-strong correlations with established measures. Scores from the PLATO questionnaire also discriminate between sleep apnea severity levels and body mass index groups, and they are responsive to symptom improvement.
“The PLATO questionnaire is a valid and reliable patient-reported outcome tool that fills a significant void in the field of sleep medicine,” said lead author Dr. Douglas Kirsch, a board-certified sleep medicine physician and past president of the AASM. “The 11-item questionnaire can be completed in less than four minutes and is easy to score, making it simple to implement, even in busy clinical settings.”
The manuscript is available online as an accepted paper and will be published in the Oct. 1 issue of the Journal of Clinical Sleep Medicine, the official publication of the AASM.
Nearly 30 million adults in the U.S. have obstructive sleep apnea, a chronic disease that involves repeated collapse of the upper airway during sleep. Sleep apnea is commonly treated with CPAP therapy, which uses mild levels of air pressure, provided through a mask, to keep the airway open during sleep.
An AASM task force previously evaluated outcome assessment tools for sleep apnea, finding that no single tool met all the criteria for clinical validity and feasibility. To address this need, the AASM engaged ICON, a contract research organization, to develop PLATO in collaboration with a medical expert advisory panel of AASM members. They developed PLATO in accordance with Food and Drug Administration guidance on developing and validating outcome measures, utilizing a multi-phase, mixed-methods approach. The process included cognitive interviews with patients, pilot testing in 10 AASM-accredited sleep centers, and psychometric validation using longitudinal online surveys in 560 adults with sleep apnea and 40 controls.
PLATO comprises 11 questions that assess patients’ sleep-related experiences in the past seven days and nights. The questions address topics such as feeling tired or sleepy, experiencing morning headaches or snoring, and overall sleep quality. Patients can complete PLATO during clinic visits before therapy is implemented and at various times after treatment begins to monitor a patient’s response to any form of sleep apnea therapy.
PLATO was written at a 5th-grade reading level and is available in English and Spanish. It is accessible in both paper and electronic formats, allowing for easy scoring through a manual or electronic process. The electronic format is compatible with electronic health record platforms.
“The PLATO questionnaire is ready for clinical implementation, and longitudinal data collection using this tool will improve our understanding of the value of sleep apnea treatment to patients, health care professionals, payers, and health systems,” said Kirsch.
A related commentary in the Journal of Clinical Sleep Medicine emphasizes that PLATO “has several advantages over prior instruments to assess outcomes,” and it notes that a “thoughtful and statistically sound process was used to develop and modify this tool.”
The other members of the medical expert advisory panel were Dr. Fariha Abbasi-Feinberg, Dr. Charles Davies, Dr. Charlene Gamaldo, and Dr. Carol Rosen. ICON staff who led the development of PLATO were Patricia Koochaki, Christiane Otto, and Kelly Lipman. The project was coordinated by Sherene Thomas of the AASM.
PLATO can be licensed for free for use in clinical practice. Licensing information will be available soon from Mapi Research Trust.
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For a copy of the manuscript, “The Patient-reported Longitudinal Assessment Tool for OSA (PLATO): development and validation of a new clinical tool to assess response to obstructive sleep apnea treatment in adults,” or the commentary, “Sleep apnea, how do we help thee? Let us count the ways,” or to schedule an interview with Dr. Kirsch or another sleep expert, please send an email to aasm@lcwa.com.
About the American Academy of Sleep Medicine
Established in 1975, the AASM is a medical association that advances sleep care and enhances sleep health to improve lives. The AASM membership includes more than 9,500 physicians, scientists, and other health care professionals who help people who have sleep disorders. The AASM also accredits 2,300 sleep centers that are providing the highest quality of sleep care across the country (aasm.org).
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