Study Design: A cross-sectional retrospective observational study design of patients who tested positive for SARS-CoV-2 (Covid19) was adopted [8].
Setting
Clinical data was collected from Covid19 patients hospitalized at the only two public hospitals in Al Ain, that catered to more than 98% of the total positive Covid19 caseload. Largely, these two public hospitals address the secondary and tertiary care needs of the population of the eastern region of the United Arab Emirates. The study period was between April 15 and June 15, 2020, during the peak of the contagion in the UAE [9].
Participants: All the patients hospitalized for Covid19 disease at the two public hospitals were selected for the study provided they met the inclusion criteria: a) hospitalized patients 18 years of age or older, b) all nationalities, c) had a confirmed positive COVID-19 RTPCR test result, d) both male and female, e) were initially seen at the emergency department, in-patient units, and the designated COVID-19 screening tents, f) presenting with Covid19 Pneumonia & Acute Respiratory Distress Syndrome (ARDS) per Berlin criteria [10], and g) on mechanical ventilation. The exclusion criteria comprised of: a) patients who died within twenty-four hours of admission, b) had a history of hypersensitivity to methylprednisolone, c) diagnosed and living with human immunodeficiency virus or AIDS, d) had a history of chronic use of corticosteroids or immunosuppressive agents, e) diagnosed with decompensated cirrhosis, and/or chronic renal failure, f) the patients on ”Do Not Resuscitate” because of advanced age or morbid conditions, g) patients below the age of 18 years (pediatric), and h) with incomplete (demographic information) or missing (Rapid Antigen Test instead of the RT-PCR for SARS-Cov2) documentation.
Variables
The patients on the standard supportive care group (AICU) received the ARDS net protocol for ventilation, hydroxychloroquine along with standard Intensive Care Unit (ICU) protocols for sedation, weaning, and glycemic control. Patients in the other group (TICU), in addition to standard supportive care, were administered Methylprednisolone (0.5mg/kg per day), continuously for a minimum of 5 days, the maximum duration of treatment was left to the physician’s discretion. Serial measurements on days 0, 1, 3, and 7 following methylprednisolone administration included Ferritin, Interleukin 6, C-Reactive Protein, D-dimer, and blood glucose levels, and compared with the patients on standard supportive care [11]. In addition, the date of admission, the 28-day mortality, the total number of days stayed in the hospital (Hospital Length of Stay, hLOS ), the total number of days stayed in the intensive care unit (iLOS), and the total number of days intubated were extracted from the electronic medical records of the hospitals patient information system.
Data Source
The required clinical progress and patient outcomes data were abstracted from the patient electronic medical records of the Hospital Information System (Cerner, USA). Cerner system has been validated and used by all of the Abu Dhabi Health Services Company-managed public hospitals in the UAE since 2008 [12]. The data collected was recorded in the Microsoft Excel sheets, secured for authorized access by using a password. Standard statistical tests were applied to estimate the difference between the various variables, and are described under the” statistical analysis”.
Bias
The Steroid Tawam & Alain Hospitals Research (STAR) group, consisting of physician-researchers, extracted data for the study from the patient medical records, but were blinded to the study hypothesis. Interrater reliability, Cohen’s kappa coefficient, was used to assess the differences between the data abstractors [13]. Selection and operator bias were excluded by involving multiple data abstracters.
Study Size
The study period was during the peak of the contagion in the UAE, therefore all the hospitalized adult Covid19 patients, at both the public hospitals were selected for the study. From a total of 83 patients, 70 patients that met the inclusion criteria were shortlisted and their data abstracted. The remainder of 16 patients were excluded from the study for the reasons listed under the “participants.”
Statistical Methods
Data were analyzed using SPSS (IBM, Chicago) Version 26. All hospitalized patients during the study period with Covid19 were selected for the study, and shortlisted based on the inclusion criteria. Interrater reliability test was applied to assess the agreement of the data collected between the data abstractors. The Cohen Kappa for the data abstractors was 0.72, indicating good agreement. Descriptive and inferential statistical methods were used to analyze the data. First, the frequency and percentages are taken for all variables, and then the important variables cross-tabulated with the outcome (Deceased/Survived). The Chi-Square test was used to find the association between the outcome variable and other independent variables. The level of significance was taken as P < 0.05.
Ethics Statement
The methods of the study were carried out per the International Conference for Harmonization (ICH), and Good Clinical Practice guidelines. Waiver of written informed consents for participation in this retrospective observational study was granted by the Abu Dhabi Technical and Scientific Human Research Ethics Committee, a central research ethics committee at the department of health Abu Dhabi, UAE.