Operationalisation of post-COVID condition case definition in a comprehensive research protocol.
Federico Masserini1, Alessia Nicotra1, Arianna Forgione1
1Department of Biomedical and Clinical Sciences, Neuroscience Research Center, University of Milan, Milan, Italy.
A new screening tool and assessment protocol were developed to standardize the identification of Post-COVID-19 condition (PCC) cases. This aims to improve reproducibility and comparability in research and clinical studies for better patient inclusion.
Area of Science:
- Neurology
- Psychiatry
- Infectious Diseases
Background:
- Post-COVID-19 condition (PCC) is a significant sequela of SARS-CoV-2 infection.
- Current PCC case definitions lack standardization and reproducibility due to complex manifestations.
- This hinders consistent patient identification for research and clinical studies.
Purpose of the Study:
- To develop a simple screening tool for reproducible and comparable PCC case definition.
- To establish a framework for reliably identifying suspected PCC cases.
- To create a comprehensive assessment protocol for frequently reported PCC characteristics.
Main Methods:
- A European multi-center study was conducted.
- A checklist was devised based on a systematic review to assess PCC symptoms and their temporal relation to COVID-19.
- The protocol includes neuropsychological evaluations and validated self-administered scales.
Main Results:
- The screening checklist includes cognitive, psychiatric, and general symptom cores.
- Symptom onset within 3 months post-COVID-19 resolution and persistence for at least 2 months are key criteria.
- Suspicion of PCC is triggered by any qualifying symptom; neuropsychiatric involvement requires at least one cognitive or psychiatric symptom.
Conclusions:
- Standardized identification of PCC cases is crucial for accurate patient inclusion in studies.
- A simple, reproducible, and flexible screening tool is proposed.
- A comprehensive assessment protocol is offered to enhance standardization and comparability in PCC research.
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