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Advancing patient-centred outcomes in sleep medicine: Filling the gap with PLATO-11

Obstructive sleep apnoea (OSA) is a prevalent and underdiagnosed condition associated with significant health risks, including cardiovascular disease, cognitive impairment and reduced quality of life. Despite the availability of effective therapies, clinicians have long lacked a concise, validated and freely accessible tool to monitor patient-reported outcomes throughout the course of treatment. 

To advance a more patient-centred approach and address this unmet need, the American Academy of Sleep Medicine (AASM) commissioned the development of a new patient-reported outcome (PRO) instrument. ICON collaborated with the AASM to lead the development and validation of the instrument designed to assess treatment response in adults with OSA, resulting in the reliable, publicly available PLATO-11. 

The project was guided by a commitment to patient centricity, regulatory rigour and clinical utility, with the goal of producing a tool that accurately reflects the lived experience of individuals with OSA and supports evidence-based care.

Addressing the need for patient-centred assessment tools

Existing instruments such as the Epworth Sleepiness Scale (ESS) and the Functional Outcomes of Sleep Questionnaire (FOSQ) offer limited scope or require paid licensing for clinical use. Moreover, many tools fail to capture the full spectrum of OSA-related symptoms and impacts, particularly those affecting daytime functioning, mood and interpersonal relationships. The AASM’s 2016 review of available OSA questionnaires concluded that no short, validated, and freely available PRO tool existed to support longitudinal monitoring in clinical practice.

PLATO-11 was developed to address this gap. It is designed to be brief, psychometrically robust, reliable and valid, and accessible across diverse clinical settings, with a focus on capturing outcomes that matter most to patients.
 

Integrating qualitative and quantitative evidence

The development of PLATO-11 followed a multi-phase approach using qualitative and quantitative research methods aligned with US Food and Drug Administration (FDA) guidance for PRO instruments. ICON led the research and analysis in collaboration with a panel of sleep medicine experts.

Phase 1: Concept elicitation and cognitive interviews
Interviews with patients and spouses identified key symptoms and impacts of OSA, including fatigue, mood disturbances, cognitive difficulties and relationship strain. These direct from patient insights informed the initial 43-item pool and ensured relevance to their lived experience.

Phase 2: Usability testing and clinician feedback
The draft tool was narrowed to 31 items for testing and feedback. It was piloted in 10 different sleep clinics across the United States. Clinician feedback via Pragmatic Content and Face Validity Test (PRAC-Test) reported high levels of satisfaction with its clarity, practicality and potential to support treatment monitoring.

Phase 3: Psychometric validation
A longitudinal, quantitative study involving 560 adults with OSA and 40 controls assessed the tool’s reliability, validity and responsiveness to change. Results from the study were used to develop two versions of PLATO. A longer PLATO-22 with 22 items was developed based on methods from classical test theory that provides a total score (including all 22 items) and 6 subdomain scores (subscales on Sleepiness, Mood, Apnea Arousal, Sleep Quality, Alertness, and OSA Symptoms) that is more appropriate for research studies. Rasch modelling and classical test theory also supported item reduction of PLATO-22 to create the shorter 11-item version, PLATO-11, that is appropriate and optimised for use in clinical practice. 

Meaningful design: Capturing the clinical and the human

Central to the development of PLATO-11 was a commitment to patient-centricity—ensuring that the new tool reflects the real experiences, priorities and languages of individuals it serves. 

Rather than relying solely on clinical metrics or expert assumptions, the development process began with direct input from patients and their spouses through concept elicitation interviews. These conversations revealed a wide range of symptoms and impacts that extend beyond sleepiness, including emotional wellbeing, cognitive function, relationship strain, and daily activity limitations.

This qualitative foundation informed every stage of item selection and refinement. Patients were actively involved in usability testing, helping to shape the tool’s language, format, and response scales. Their feedback led to meaningful revisions, such as simplifying instructions, clarifying time anchors, and selecting terminology that resonated with their experiences.

Obtaining clinician feedback on the utility, convenience, and relevance of the PRO instrument for use in clinical practice, prior to psychometric validation was also an important part of the development process.

The result is a PRO instrument that is not only scientifically rigorous but also relevant and reflective of the patient voice. PLATO-11 empowers individuals with OSA to report their symptoms in a way that is intuitive and meaningful, supporting shared decision-making and personalised care. By capturing both the clinical and human dimensions of OSA, PLATO-11 exemplifies how patient-centred design can enhance the utility and impact of outcome measurement in real-world practice.

Demonstrated outcomes

PLATO-11 captures the most meaningful and sensitive items selected by prioritizing clinical expertise. It has demonstrated strong psychometric properties across multiple domains:

  • Reliability (internal consistency and test-retest reliability)
    Cronbach’s alpha and coefficient omega exceeded 0.90, indicating excellent internal consistency. PLATO-11’s excellent test-retest reliability was confirmed with intraclass correlation coefficients above 0.80.
  • Construct validity (convergent and known-groups validity)
    PLATO-11 scores correlated strongly with established measures of sleepiness, functional outcomes, and sleep-related impairment. Significant differences were observed across OSA severity and BMI groups, supporting its clinical validity.
  • Responsiveness to change and meaningful change thresholds
    Importantly, the tool effectively detected symptom improvement over time. Thresholds for clinically meaningful change are provided which have been derived using anchor-based and distribution-based methods.
  • Accessibility and format
    PLATO-11 is written at a fifth grade reading level, takes under four minutes to complete and is available in both English and Spanish languages. It can be administered either on paper or electronically, facilitating simple integration with electronic health records and digital health platforms.

Practical implications for clinical research

PLATO-11 offers a practical solution for monitoring patient-centred outcomes in OSA management. Its brevity and clarity make it suitable for routine use in sleep clinics, while its validated scoring system supports longitudinal tracking and treatment evaluation. By capturing both nocturnal symptoms and daytime quality of life impacts, PLATO-11 enables a more holistic understanding of treatment efficacy from the patient’s perspective.

Furthermore, the tool’s public availability and multilingual support enhance its potential for widespread adoption and cross-cultural research. Future studies will explore its application in diverse populations, its sensitivity to worsening symptoms, and its relationship to long-term quality-of-life and economic outcomes.

An asset for advancing patient outcomes

The development of PLATO-11 represents a significant advancement in patient-centred care for individuals with OSA. Through rigorous methodology and a collaborative, multidisciplinary approach, ICON and the AASM have delivered a validated, accessible, regulatory-aligned and clinically meaningful PRO instrument. PLATO-11 empowers patients and supports evidence-based decision-making in sleep medicine, paving the way for elevated standards of care. 

As healthcare continues to evolve towards personalised and outcomes-driven models, tools like PLATO-11 are invaluable assets and will play a critical role in aligning clinical practice with the needs and experiences of patients.

At ICON, we remain committed to advancing patient-centred research that leads to better outcomes, experiences and quality of life. To learn more about how we put patients at the heart of clinical research, connect with us. 

Read the published PLATO study results in the Journal of Clinical Sleep Medicine.

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