Study Design and Participants
For this single-center, cross-sectional, retrospective, observational study, all symptomatic patients visiting a specially designated area, the “Cough Clinic” of a Tertiary Hospital in southern part of West Bengal, India, were included. All symptomatic patients who reported to the “Cough Clinic” of the hospital were studied. Asymptomatic contacts as well as patients undergoing COVID-19 testing as part of screening have not been included.
Methodology
This study was carried out in a tertiary care multi-specialty hospital, which has a dedicated wing for COVID-19 patients since the beginning of March 2020. The current study is a cross-sectional retrospective observational study of presenting symptoms of suspected COVID-19 patients who presented themselves to this center during the outbreak of 2019–2020 from 1 August 2020 to 30 August 2020. It also evaluates the pre-test history and symptom-based predictive accuracy of primary care physicians in identifying potentially positive cases. As this is an observational non-interventional study with no invasion of patient privacy, ethical clearance has been dispensed with.
The “Cough Clinic” was a standalone double-storied building, adjacent to the Emergency Department of the hospital, which initially served as a place to receive and stock medical stores prior to their dispatch to the various wards and departments. It was converted into a designated place to receive, register, and render initial care to any patient with symptoms indicative of COVID-19 infection. Any patient coming to hospital with complaints of fever or respiratory tract involvement such as shortness of breath and cough is referred to the Cough Clinic. Patients were referred to the Cough Clinic from the various outpatient departments of the hospital or from smaller satellite centers located in different parts of the city and other dependent geographical areas.
Design and Layout
The Cough Clinic, a two-storied structure, is located at a linear distance of approximately 200 m from the main entrance to the hospital. The entrance to the clinic is by foot or ambulance through an approach road that had been cordoned off and made off-limits to everyone else. The ground floor of the clinic serves as the main area for receiving and stabilizing critical patients, assessing the stable patients, for drawing blood samples, and taking chest radiograph wherever indicated. The room has three emergency beds which are spaced at a distance of 2 m from each other, and two tables at the far corners with a distance of more than 10 m between them. The first floor of the clinic serves as the main room where naso-pharyngeal and oro-pharyngeal swabs are drawn for RT-PCR testing for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and stored as per established guidelines [2].
Resource Management and Continuous Training of HCW
A team of six doctors had been earmarked from the beginning of March, and the same team continued to work there in rotation during the working hours of the hospital. Off-duty hours, the center is manned by doctors taken from a central roster, in a sequential order, assisted by other HCW. Three doctors from the day team work for a period of 2 weeks at a time, following which they undergo 2 weeks of institutional quarantine. The off-duty hours doctors worked for one shift of 12 h each. With each passing day, as the pandemic evolved, our knowledge of the symptoms, danger signals, early therapeutic goals, and management protocols also evolved. Simultaneously, the designated doctors were re-trained at the beginning of each cycle of 4 weeks in recognizing the clinical features of the disease and were brought up to date with the latest relevant information about the disease. In addition, the same briefing was conducted for the entire staff manning the clinic in off-duty hours.
Clinical Workflow
The patients referred to the Cough Clinic are directed to the clinic by various means, which include non-contact thermal screening at the entrance to the hospital, a screening for potential symptoms by a HCW at the entrance to the hospital, and large multi-lingual billboards and signage pointing the way. On arrival at the Cough Clinic, the patients who are stable sit in an open area outside the building. The patients who arrive in ambulances, with ongoing oxygen support, or require any other monitoring or supportive therapy like ventilation etc. are received on the beds inside the clinic. The seating area is in the open, with chairs spaced at least 2 m apart in all directions. The ground floor is manned by at least three doctors during the working hours, and one during the off-working hours. They are assisted by a trained team of six paramedical HCW in each shift that lasts for 8 h. All the personnel are dressed in personal protective equipment (PPE) at all times during their duty. The patients are called inside the clinic serially, with no more than two patients allowed inside the clinic at one time, and if there is a patient in any of the emergency beds, then no patients are called inside at all.
Medical History and Symptom-Based Pre-test Probability Assessment for COVID-19 and Triaging
After taking detailed history, including history of travel and contact with suspected or confirmed cases of COVID-19, and presence or absence of comorbidities, the patients are examined. At this point of time, the attending doctor notes down presence or absence of fever and one more important symptom for which the patient has reported to the Cough Clinic. The doctor then makes a pre-test probability of the patient to be actually suffering from COVID-19 which is conveyed telephonically to the consultant who is the overall in-charge of the care of all patients with COVID-19 and makes a final decision regarding the disposal of each patient.
Diagnostic Testing
After documentation of the patient’s particulars, symptoms, and pre-test probability of a positive RT-PCR test based on the doctor’s assessment, eligible patients undergo further investigations which include sampling of blood for hematology and biochemistry, radiography of the chest, and filling up of the form for sampling for assessing SARS-CoV-2 infection by real-time polymerase chain reaction (RT-PCR) [3, 4].
Post-test Triaging and Patient Management
Those patients who are deemed stable or at a low risk for SARS-CoV-2 infection are sent home for isolation, and those who are unstable or at a high risk for the infection are placed in the containment rooms in a staging ward pending confirmation of the infection. The reports of all samples collected during the working hours are made available in the late evening hours following which appropriate action is taken at the ward to shift the positive cases to the COVID ward. Those patients who were sent home and are detected to be positive are called back to the hospital for admission, along with their household contacts that undergo sampling by naso-pharyngeal and oro-pharyngeal swab collection for detection of SARS-CoV-2 infection by RT-PCR. Triaging and management is done as per institutional protocols based on available literature and guidelines [5, 6].
The objective of this study was to assess how efficiently primary care physicians at the “Cough Clinic” were able to predict whether a patient had COVID-19 or not, based on their clinical assessment alone. They were asked to ascribe a pre-test probability of the patient having COVID-19, based on their assessment in the Cough Clinic. This data was entered and later on compared with the actual result based on RT-PCR testing.
Statistical analysis and data visualization have been done in statistical programming language R version 3.6.3. Receiver operating characteristics (ROC) curves were used to summarize the accuracy of predictions based on presenting symptoms.