Study setting, design, and sampling
This case-control study was conducted at the rheumatology outpatient clinics of the Zagazig University hospitals in Sharkia province, Egypt, from October 1st, 2020, to March 31st, 2021. The sample size was calculated according to a 95% confidence interval (CI), at 80% power of the study, the ratio of sample size 1:1. The patient group included a total of 100 subjects diagnosed as patients with RA if they had scored 6 or more points based on the rheumatoid arthritis criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) collaborative initiative . Patients aged from 18 to 60 years, of both sexes, and able to give consent, were included in the study. An equal number of healthy subjects, who were age and sex-matched, were enrolled as a control group. All subjects were consecutively selected using a convenience sampling method. All participants with a confirmed history of psychiatric disorders (before the pandemic), based on the history taken or their medical records, were excluded from this study. Moreover, participants with concurrent major neurocognitive disorders, intellectual disabilities, and/or substance use disorders were excluded, as their presence would affect the credibility to participate in the study. All procedures were conducted within the ethical guidelines outlined in the declaration of Helsinki and its later amendments, and all participants were requested to sign an informed consent after explaining the study objectives and procedures.
Using a semi-structured checklist, all study participants were interviewed to collect demographic and COVID-19-related data. The COVID-19-related data included questions about whether the participants or their close family members were previously infected with the COVID-19 virus, history of COVID-19 mortality among close relatives, and whether they were compliant or not with the COVID-19 precautions like social distancing or protective equipment measures.
Psychological assessment of study participants
Symptom Checklist-90 scale (SCL-90)
SCL-90 was used as a descriptive measure of psychopathology detecting the current symptom severity in various patient populations. The concurrent psychological symptoms in patients with RA during the pandemic, screened by the SCL-90 checklist, might be considered as potential confounders related to the reaction to the pandemic or the illness itself. SCL-90 included ninety questions answered by the participants on a five-point Likert scale ranging from 0 (none) to 4 (extreme) representing the nine symptom dimensions for the past 1 month: namely, somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. Additionally, there were three global indices: namely Global Severity Index (GSI), which was the mean sum of the 90 items, Positive Symptom Distress Index (PSDI), which was the mean sum of only the above-zero items, and lastly, Positive Symptoms Total (PST), which was the number of the above-zero items [14, 15].
Fear of COVID-19 scale (FCV-19S)
FCV-19S was a new short valid seven-item psychometric scale used to assess the participants’ intensified anxiety and fear of COVID-19 infection. The participants used a five-item Likert-type response to indicate their level of agreement with each statement. The score for each question ranged from 1 (strongly disagree) to 5 (strongly agree), with a total score ranging from 7 to 35. The higher the score, the greater the fear of coronavirus-19 [16, 17].
World Health Organization quality of life scale (WHOQOL-BREF)
WHOQOL-BREF was used to assess the quality of life (QoL). It was composed of a total of 26 questions based on a four-domain structure: physical health, psychological, social relationships, environment. Items were answered on a 5-point scale with a 2-week timeframe. The mean of items within each domain was multiplied by four to yield the domain score (ranging from 0 to100), and the higher scores indicate higher QoL [18, 19].
Clinical assessment of patients with RA
The following measurement tools were applied to assess the clinical impact of the pandemic as well as the COVID-19-related factors like associated fear, anxiety, and depression on the physical status, disease activity, and functioning of patients with rheumatoid arthritis (RA). In this study, the clinical impact was assessed using the following measures:
Disease activity score 28 (DAS28)
DAS28 was used to assess RA disease activity . It is a short scale derived from the original DAS with the inclusion of fewer joints. It consisted of a 28 tender joint count (ranged from 0 to 28), a 28-swollen joint count (ranged from 0 to 28), ESR, and GH on a VAS scale (ranged from 0 to 100). DAS28 was scored as a continuous index ranging from 2 to 10, where the patients were divided into four disease activity grades (remission, low, moderate, and high activity) .
Modified health assessment questionnaire (MHAQ)
MHAQ was a self-reported outcome questionnaire and used to measure the functional status of patients with RA. It included questions about the perceived patient’s satisfaction regarding the same daily activities, as well as the change in the degree of difficulty. Patients were divided into normal, mild, moderate, and severe according to their functional status .
SPSS program (Statistical Package for Social Science) version 18.0 was used to analyze the collected data. The differences between the qualitative variables between groups were estimated using the Chi-square test (χ2). Paired Student test (t-test) was used for comparison between two groups for continuous variables and the Mann-Whitney-U (MWU) test for non-normally distributed data. To evaluate the correlation between two variables that had a linear relationship, Pearson’s correlation coefficient was applied. Results were considered significant when their probability was less than 5% (P<0.05).