Development and validation of a measurement instrument to assess health-related quality of life (HRQoL) in Long COVID-19 (QoLCOVI)

• Applicant: Professor Dr. Christian Apfelbacher, Ph.D.
• Subject Area: Public Health, Healthcare Research, Social and Occupational Medicine ; Epidemiology and Medical Biometry/Statistics ; Personality Psychology, Clinical and Medical Psychology, Methodology
• Term: since 2022
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 503976291

Coronavirus Disease (COVID) - 19 caused by coronavirus SARS-CoV-2 is increasingly associated with long-lasting symptoms persisting more than 12 weeks after infection. In this long-term symptomatology, known as Long COVID, even a mild progression of the disease can lead to serious impacts such as shortness of breath after a few steps or the loss of sense of taste and smell. Patients admitted to intensive care seem to be at increased risk of developing more frequent and more severe Long COVID symptoms. It is evident that Long COVID-19 likely affects the physical, emotional, social and cognitive components of health-related quality of life (HRQoL). However, an instrument systematically capturing these impacts from the perspective of individuals affected by Long COVID has not been developed and validated so far. The overall aim of this project is to develop and validate a Long COVID-19-specific patient-reported outcome measure (PROM) to assess HRQoL in Long COVID-19 patients. The specific aims of this project are 1) to identify HRQoL issues in patients suffering from Long COVID-19 symptoms that inform the generation of a conceptual framework about HRQoL issues in Long COVID-19, 2) to generate a set of draft items, 3) to assess the content validity of those draft items, 4) to systematically reduce items and refine the draft PROM using classical test theory (CTT), item response theory (IRT) and Rasch analysis, 5) to validate the content of the final PROM, 6) to assess the psychometric properties of the new PROM including the assessment of aspects on interpretability and feasibility.The Wilson and Cleary model of HRQoL will be used to guide the proposed development. After a systematic review of recent Long COVID-19 literature, qualitative research with patient and expert interviews and focus groups will be used to elicit a conceptual model (task 1). This will be followed by the generation of a pool of items based on patient input (task 2). After the content validation of the initial set of items (task 3), a first prototype PROM will be available. This prototype will be used in a first quantitative study that aims to reduce the number of items and to identify the most suitable items and the underlying factor structure. The appropriateness of the response options will be assessed (task 4). Content validity of the final set of items and the suitability of the recall period, the instructions and the wording of the response options will be confirmed using patient interviews (task 5). The final PROM will be psychometrically validated in a second quantitative study in order to determine its measurement properties as well as aspects of interpretability and feasibility of this new PROM (task 6). This project will create a brief high-quality PROM that will be tailored to Long COVID-19-specific HRQoL aspects for use in future epidemiological research and clinical trials, as well as clinical practice.

• DFG Programme: Research Grants