Impact of Chronic Use of Antimalarials on SARS-CoV-2 Infection in Patients With Immune-Mediated Rheumatic Diseases: Protocol for a Multicentric Observational Cohort Study

Gomides, Ana Paula Monteiro; Ferreira, Gilda Aparecida; Kakehasi, Adriana Maria; Lacerda, Marcus Vinícius Guimarães; Marques, Cláudia Diniz Lopes; Mota, Licia Maria Henrique da; Paiva, Eduardo dos Santos; Pileggi, Gecilmara Cristina Salviato; Provenza, José Roberto; Reis-Neto, Edgard Torres; Sampaio, Vanderson de Souza; Xavier, Ricardo Machado; Pinheiro, Marcelo M.

doi:10.2196/23532

Cited by 6 publications

(8 citation statements)

References 51 publications

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“…The REDCap platform is intended to support clinical research [7]. Utilization of REDCap has grown substantially in epidemiology, especially in studies of coronavirus disease 2019 (COVID-19) [16][17][18][19][20][21][22]. The major advantages of using the REDCap software are long-term reduction of research costs, the possibility of utilization on both smart devices and desktop computers, and rapid data entry, review, and analysis [6].…”

Section: Discussionmentioning

confidence: 99%

Research Development Using REDCap Software

Garcia¹,

Abrahão

2021

Healthc Inform Res

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Objectives: High-quality clinical research is dependent on adequate design, methodology, and data collection. The utilization of electronic data capture (EDC) systems is recommended to optimize research data through proper management. This paper’s objective is to present the procedures of REDCap (Research Electronic Data Capture), which supports research development, and to promote the utilization of this software among the scientific community.Methods: REDCap’s web application version 10.4.1 released on 2021 (Vanderbilt University) is an EDC system suitable for clinical research development. This paper describes how to join the REDCap consortium and presents how to develop survey instruments and use them to collect and analyze data.Results: Since REDCap is a web application that stimulates knowledge-sharing among the scientific community, its development is not finished and it is constantly receiving updates to improve the system. REDCap’s tools provide access control, audit trails, and data security to the research team.Conclusions: REDCap is a web application that can facilitate clinical research development, mainly in health fields, and reduce the costs of conducting research. Its tools allow researchers to make the best use of EDC components, such as data storage.

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Section: Discussionmentioning

confidence: 99%

Research Development Using REDCap Software

Garcia¹,

Abrahão

2021

Healthc Inform Res

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“…As future perspectives, the shortage of HCQ with potential effects after withdrawal [78][79][80][81] will be further explored during the 24-week follow-up, as well as hospitalization and mortality rate [82].…”

Section: Discussionmentioning

confidence: 99%

Chronic use of hydroxychloroquine did not protect against COVID-19 in a large cohort of patients with rheumatic diseases in Brazil

Pileggi¹,

Ferreira

Reis

et al. 2021

Adv Rheumatol

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Background There is a lack of information on the role of chronic use of hydroxychloroquine during the SARS-CoV-2 outbreak. Our aim was to compare the occurrence of COVID-19 between rheumatic disease patients on hydroxychloroquine with individuals from the same household not taking the drug during the first 8 weeks of community viral transmission in Brazil. Methods This baseline cross-sectional analysis is part of a 24-week observational multi-center study involving 22 Brazilian academic outpatient centers. All information regarding COVID-19 symptoms, epidemiological, clinical, and demographic data were recorded on a specific web-based platform using telephone calls from physicians and medical students. COVID-19 was defined according to the Brazilian Ministry of Health (BMH) criteria. Mann–Whitney, Chi-square and Exact Fisher tests were used for statistical analysis and two binary Final Logistic Regression Model by Wald test were developed using a backward-stepwise method for the presence of COVID-19. Results From March 29th to May 17st, 2020, a total of 10,443 participants were enrolled, including 5166 (53.9%) rheumatic disease patients, of whom 82.5% had systemic erythematosus lupus, 7.8% rheumatoid arthritis, 3.7% Sjögren’s syndrome and 0.8% systemic sclerosis. In total, 1822 (19.1%) participants reported flu symptoms within the 30 days prior to enrollment, of which 3.1% fulfilled the BMH criteria, but with no significant difference between rheumatic disease patients (4.03%) and controls (3.25%). After adjustments for multiple confounders, the main risk factor significantly associated with a COVID-19 diagnosis was lung disease (OR 1.63; 95% CI 1.03–2.58); and for rheumatic disease patients were diagnosis of systemic sclerosis (OR 2.8; 95% CI 1.19–6.63) and glucocorticoids above 10 mg/ day (OR 2.05; 95% CI 1.31–3.19). In addition, a recent influenza vaccination had a protective effect (OR 0.674; 95% CI 0.46–0.98). Conclusion Patients with rheumatic disease on hydroxychloroquine presented a similar occurrence of COVID-19 to household cohabitants, suggesting a lack of any protective role against SARS-CoV-2 infection. Trial registration Brazilian Registry of Clinical Trials (ReBEC; RBR – 9KTWX6).

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“…Medical students who were involved in the MPII study (volunteer group) and their colleagues who were not involved in the MPII study (control group) [ 17 ] were recruited.…”

Section: Methodsmentioning

confidence: 99%

“…A total of 6 sequential telephone calls were scheduled during the community transmission of SARS-CoV-2. These calls were performed by 395 volunteer medical students [ 17 ].…”

Section: Introductionmentioning

confidence: 99%

Effects of Participating in a Research Project During the COVID-19 Pandemic on Medical Students’ Educational Routines and Mental Health: Protocol for a Web-Based Survey Study

et al. 2021

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Background The COVID-19 pandemic has resulted in social isolation, which has a potential negative impact on the educational routines (eg, the suspension of face-to-face appointments) and mental health of medical students. The Mario Pinotti II (MPII) study is a 24-week observational study that conducted scheduled telephone calls every 2 weeks to verify the occurrence of COVID-19 in patients with rheumatic diseases on chronic hydroxychloroquine therapy (from March 29, 2020, to September 30, 2020). The effects of voluntarily participating in a research project (ie, one that involves interactions via telephone contact with patients, professors, rheumatologists, and colleagues) on the daily lives and mental health of medical students requires evaluation. Objective As medical students are professionals in training and have a high level of responsibility in terms of handling the emotional and physical aspects of several diseases, this study aims to evaluate the impacts of the COVID-19 pandemic and participation in the MPII study on the educational routines and mental health of medical students. Methods A web-based survey was carried out to perform a cross-sectional comparative assessment of medical students who participated in the MPII study and their colleagues who were not involved in the MPII study. Participants from both groups were matched based on sex, age, and medical school. The web questionnaire was developed by a panel composed of graduate medical students, rheumatologists, medical school professors, and a psychology professor. The questionnaire included details on demographic and life habits data and evaluated participants' impressions of the MPII study and the impact of the COVID-19 pandemic on their educational routines and medical training. In addition, depression, anxiety, and stress were evaluated using the Brazilian version of the Depression, Anxiety, and Stress Scale (DASS)-21, and currently, the DASS-21 scores are grouped as those that indicate a low, moderate, or high risk of mental distress. This project was approved by the Federal University of São Paulo Ethics Committee (CAAE: 34034620.0.0000.5505). Results Data were collected from both medical student groups from July 20 to August 31, 2020. Data extraction was completed in September 2020. The data analysis is ongoing. We expect the results to be published in the first semester of 2021. Conclusions This study will provide insight into the effects of participating in a research project on depression, anxiety, and stress, which will be determined by applying the DASS-21 to a large sample of Brazilian undergraduate medical students. We will also evaluate the impact of the COVID-19 pandemic on medical students’ educational routines and medical training. International Registered Report Identifier (IRRID) DERR1-10.2196/24617

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Impact of Chronic Use of Antimalarials on SARS-CoV-2 Infection in Patients With Immune-Mediated Rheumatic Diseases: Protocol for a Multicentric Observational Cohort Study

Cited by 6 publications

References 51 publications

Research Development Using REDCap Software

Research Development Using REDCap Software

Chronic use of hydroxychloroquine did not protect against COVID-19 in a large cohort of patients with rheumatic diseases in Brazil

Effects of Participating in a Research Project During the COVID-19 Pandemic on Medical Students’ Educational Routines and Mental Health: Protocol for a Web-Based Survey Study

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