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.

Abstract

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 FDA guidance for PRO measures, utilizing a multi-phase, 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 AASM-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 (PLATO-11) 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 (ICC = 0.91-0.97), and construct validity through moderate-to-strong correlations with established measures. PLATO-11 scores discriminated between OSA severity and BMI 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: PLATO-11 is a valid, reliable, and feasible PRO instrument for assessing OSA-related symptoms in clinical practice. It enables efficient monitoring of patient-reported outcomes across treatment stages.