Development and Validation of a Clinical Symptom-based Scoring System for Diagnostic Evaluation of COVID-19 Patients Presenting to Outpatient Department in a Pandemic Situation

Background Preventive strategies in the form of early identification and isolation of patients are the cornerstones in the control of COVID-19 pandemic We have conducted this study to develop a clinical symptom-based scoring system (CSBSS) for the diagnostic evaluation of COVID-19 Methods In this study, 378 patients presenting to screening outpatient clinic with clinical suspicion of COVID-19 were evaluated for various clinical symptoms Statistical associations between presenting symptoms and reverse transcription-polymerase chain reaction (RT-PCR) results were analysed to select statistically significant clinical symptoms to design a scoring formula CSBSS was developed by evaluating clinical symptoms in 70% of the total patients The cut-off score of the CSBSS was determined from ROC (receiver operating characteristics) curve analysis to obtain a cut-off for optimum sensitivity and specificity Subsequently, developed CSBSS was validated in the external validation dataset comprising 30% of patients Results Clinical symptoms like fever >100 degrees F, myalgia, headache, cough and loss of smell had significant association with RT-PCR result The adjusted odds ratios (95% confidence interval [CI]) for loss of smell, fever >100 degrees F, headache, cough and myalgia were 5 00 (1 78-13 99), 2 05 (1 36-3 07), 1 31 (0 67-2 59), 1 26 (0 70-2 26) and 1 18 (0 50-2 78), respectively The ROC curve and area under the curve of development and validation datasets were similar Conclusion The presence of fever >100 degrees F and loss of smell among suspected patients are important clinical predictors for the diagnosis of COVID-19 This newly developed CSBSS is a valid screening tool that can be useful in the diagnostic evaluation of patients with suspected COVID-19 This can be used for the risk stratification of the suspected patients before their RT-PCR results are generated Y