COVID-Q: validation of the first COVID-19 questionnaire based on patient-rated symptom gravity
Authors: Spinato G , Fabbris C , Conte F , Menegaldo A , Franz L , Gaudioso P , Cinetto F , Agostini C , Costantini G , Boscolo-Rizzo P 
Published: July 2021

ABSTRACTObjectivesThe aim of the present study was to develop and validate the CoronaVirus Disease – 2019 (COVID-19) Questionnaire (COVID-Q), a novel symptom questionnaire specific for COVID-19 patients, to provide a comprehensive evaluation which may be helpful for physicians.. A secondary goal of the present study was to evaluate the performance of the COVID-Q in identifying subjects at higher risk of being tested positive for COVID-19.Material and methodsConsecutive non-hospitalized adults who underwent nasopharyngeal and throat swab for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection at Treviso Hospital in March 2020, were enrolled. Subjects were divided into positive (cases) and negative (controls) in equal number. All of them gave consent and answered the COVID-Q. Patients not able to answer the COVID-Q due to clinical conditions were excluded.Parallel Analysis and Principal Component Analysis were used to identify clusters of items measuring the same dimension. The Item Response Theory (IRT)-based analyses evaluated the functioning of item categories, the presence of clusters of local dependence among items, item fit within the model and model fit to the data.ResultsAnswers obtained from 230 COVID-19 cases (113 males, and 117 females; mean age 55 years, range 20-99 years) and 230 controls (61 males, and 169 females; mean age 46 years, range 21-89) were analyzed. Parallel analysis led to the extraction of six components, which corresponded to as many clinical presentation patterns: asthenia, influenza-like symptoms, ear and nose symptoms, breathing issues, throat symptoms, and anosmia/ageusia. The final IRT models retained 27 items as significant for symptom assessment. The total score on the questionnaire was significantly associated with positivity to the molecular SARS-CoV-2 test: subjects with multiple symptoms were significantly more likely to be affected by COVID-19 (p < .001). Older age and male gender also represented risk factors. Presence of breathing issues and anosmia/ageusia were significantly related to positivity to SARS-CoV-2 (p < 0.001). None of the examined comorbidities had a significant association with COVID-19 diagnosis.ConclusionAccording to the analyses, COVID-Q could be validated since the aspects it evaluated were overall significantly related to SARS-CoV-2 infection. The application of the novel COVID-Q to everyday clinical practice may help identifying subjects who are likely to be affected by COVID-19 and address them to a nasopharyngeal swab in order to achieve an early diagnosis.What is already known about this topic?COVID-19 symptoms are widely known. Lots of studies have been published regarding self-administered questionnaires in order to characterize and know as much as possible regarding this disease. By the way, no specific questionnaires have been validated, yet, and there is no consensus regarding this topic.What does this article add?This paper shows the COVID-Q, a novel symptom questionnaire specific for COVID-19 patients. The aim is to provide a comprehensive evaluation that may be helpful to clinicians in order to suspect SARS-CoV-2 infection or not.