Development of an international questionnaire to assess patient-reported symptoms and concerns related to COVID-19 disease, the COVID-19 QLQ-##

According to the literature and the press, the COVID-19 disease implies a complex symptom burden in the acute and subacute phase, but possibly also with long term side effects. The social implications of the disease also have negative impact on the patients’ health-related quality of life (HRQoL). In addition, the treatments that are tested in clinical trials may have serious side effects. To our knowledge, there is currently no available disease specific questionnaire for this patient group. Available generic HRQoL-questionnaires such as SF-36/Rand 36 and EQ-5D may be used, but those will not capture the symptoms and other issues that are of particular importance for these patients. Another strategy might be to use questionnaires or combination of questionnaires developed and validated for other patient groups with similar symptoms, but the validity and reliability of such an approach can be questioned. A COVID-19 specific questionnaire developed according to international recognised guidelines, will by definition, cover the relevant health-related issues for these patients, will be more sensitive to change in patients’ condition over time and provide a better ability to capture differences between treatment groups. Therefore, there is an urgent need to develop an appropriate instrument to be used alone or together with generic instruments. .

Aim of study
The aim is to develop and validate an international COVID-19 specific questionnaire that can be used alone or together with other generic questionnaires for patients with verified COVID-19 disease, in clinical studies and clinical praxis, at diagnosis, during active disease and treatment and in the recovery phase. It might be relevant to develop a core questionnaire with optional additional sub-scales relevant for different clinical situations and treatments.

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