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.

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.