A Core Outcome Set for Clinical Trials on Post COVID-19 Condition: "What," "When," and "How" to Measure.

Area of Science:

• Medical research
• Clinical trial methodology
• Public health

Background:

• Post COVID-19 condition (PCC) presents a complex array of symptoms impacting patients long-term.
• Standardized outcome measurement is crucial for effective clinical trials and evidence synthesis in PCC research.

Purpose of the Study:

• To establish a consensus-driven core outcome set (COS) for assessing post COVID-19 condition (PCC).
• Define the essential outcomes, measurement methods, and timing for PCC in clinical research.

Main Methods:

• Literature review and surveys identified potential outcomes and measurement tools.
• Two Delphi survey rounds involving diverse stakeholders refined outcome selection.
• A consensus meeting finalized the core outcome set for PCC (COS-PCC).

Main Results:

• Nine core outcomes across respiratory, physical, neuropsychological, and health domains were prioritized.
• Specific measurement tools were agreed upon for dyspnea, cough, exercise capacity, fatigue, pain, sleep, anxiety, depression, and health status.
• Consensus was also reached on 16 optional measurement methods and prioritized measurement phases (short-term and long-term).

Conclusions:

• The COS-PCC provides a standardized framework for assessing post COVID-19 condition in clinical trials.
• This set will enhance comparability and reliability of research findings.
• Continuous updates are recommended as understanding of PCC evolves.