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Study Objectives: <p>To develop and validate a publicly available, patient-reported outcome (PRO) tool specific to obstructive sleep apnea (OSA) in adults, designed for clinical use to monitor treatment response and longitudinal symptom progression.</p> Methods: <p>The PRO tool was developed in accordance with Food and Drug Administration guidance for PRO measures, utilizing a multiphase, mixed-methods approach. Part 1 involved concept elicitation and cognitive interviews with patients to identify key symptoms and impacts. Part 2 consisted of pilot testing the draft tool in 10 American Academy of Sleep Medicine-accredited sleep centers. Part 3 included psychometric validation using longitudinal online surveys in 560 adults with OSA and 40 controls. Analyses included exploratory factor analysis, Rasch modeling, test-retest reliability, internal consistency, construct validity, responsiveness to change, and determination of clinically important difference thresholds.</p> Results: <p>The final 11-item Patient-reported Longitudinal Assessment Tool for OSA has a 7-day recall period and assesses both daytime and nighttime OSA symptoms. It demonstrated strong internal consistency (α = 0.94), test-retest reliability (intraclass correlation coefficients = 0.91–0.97), and construct validity through moderate to strong correlations with established measures. The 11-item Patient-reported Longitudinal Assessment Tool for OSA scores discriminated between OSA severity and body mass index groups and were responsive to symptom improvement. The mean completion time was under 4 minutes. The tool can be used in both paper and electronic formats and has been translated into Spanish.</p> Conclusions: <p>The 11-item Patient-reported Longitudinal Assessment Tool for OSA is a valid, reliable, and feasible PRO instrument for assessing OSA-related symptoms in clinical practice. It enables efficient monitoring of PROs across treatment stages.</p> Citation: <p>Kirsch D, Abbasi-Feinberg F, Davies C, et&#xa0;al. 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. <i>J Clin Sleep Med</i>. 2025;21(10):1743–1758.</p>

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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

  • 期刊论文

  • 发表日期：

    2025年10月1日

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  • Douglas Kirsch,
  • Fariha Abbasi-Feinberg,
  • Charles Davies,
  • Charlene Gamaldo,
  • Sherene Thomas,
  • Patricia Koochaki,
  • Christiane Otto,
  • Kelly Lipman,
  • Carol L. Rosen

摘要

Study Objectives:

To develop and validate a publicly available, patient-reported outcome (PRO) tool specific to obstructive sleep apnea (OSA) in adults, designed for clinical use to monitor treatment response and longitudinal symptom progression.

Methods:

The PRO tool was developed in accordance with Food and Drug Administration guidance for PRO measures, utilizing a multiphase, mixed-methods approach. Part 1 involved concept elicitation and cognitive interviews with patients to identify key symptoms and impacts. Part 2 consisted of pilot testing the draft tool in 10 American Academy of Sleep Medicine-accredited sleep centers. Part 3 included psychometric validation using longitudinal online surveys in 560 adults with OSA and 40 controls. Analyses included exploratory factor analysis, Rasch modeling, test-retest reliability, internal consistency, construct validity, responsiveness to change, and determination of clinically important difference thresholds.

Results:

The final 11-item Patient-reported Longitudinal Assessment Tool for OSA has a 7-day recall period and assesses both daytime and nighttime OSA symptoms. It demonstrated strong internal consistency (α = 0.94), test-retest reliability (intraclass correlation coefficients = 0.91–0.97), and construct validity through moderate to strong correlations with established measures. The 11-item Patient-reported Longitudinal Assessment Tool for OSA scores discriminated between OSA severity and body mass index groups and were responsive to symptom improvement. The mean completion time was under 4 minutes. The tool can be used in both paper and electronic formats and has been translated into Spanish.

Conclusions:

The 11-item Patient-reported Longitudinal Assessment Tool for OSA is a valid, reliable, and feasible PRO instrument for assessing OSA-related symptoms in clinical practice. It enables efficient monitoring of PROs across treatment stages.

Citation:

Kirsch D, Abbasi-Feinberg F, Davies C, et al. 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. J Clin Sleep Med. 2025;21(10):1743–1758.