Evaluation of patients treated by telemedicine in the COVID-19 pandemic by a private clinic in São Paulo, Brazil: A non-randomized clinical trial preliminary study
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Abstract
Introduction
As a result of the coronavirus disease 2019 (COVID-19) pandemic the year 2020 brought major changes on the delivery of health care and face to face physician patient communication was significantly reduced and the practice of remote telehealth care using computer technology is assuming a standard of care, particularly, with COVID-19 patients with attempts to reduce viral spread.
Objective
To describe the clinical practice experience using telemedicine towards COVID-19 and the respective clinical outcomes.
Methods
We performed a pilot open-label non-randomized, controlled clinical trial. The patients were divided into four groups, according severity of symptoms: (1) asymptomatic, (2) mild symptoms, (3) moderate symptoms and (4) severe symptoms, and were followed up for five days, counted from the beginning of the symptoms. A drug intervention was performed in group 3, for which the protocol followed as suggested by the International Pulmonology Society’s consensus for adults with moderate symptoms: first day (attack phase) hydroxychloroquine sulfate 400 mg 12/12h; second to fifth day (maintenance phase) 200 mg (half pill) 12/12h. The medication was associated with azithromycin 500mg once a day for five days. For children with moderate symptoms were used: hydroxychloroquine sulfate 6.5 mg/kg/dose every 12 hours in the first day and 3.25 mg/kg/dose every 12 hours from day 2 to 5. The therapeutic response was telemonitored. Group 4 patients were directly oriented to seek hospital care. During the use of the drugs, the patients were telemonitored daily.
Results
One hundred eighty-seven patients were seen with mean age of 37,6 years (±15,6). The most frequent symptom was cough (57,6%), followed by malaise (60,3%), fever (41,1%), headache (56,0%), muscle pain (51,1%). Of all the patients that sought telemedicine service in our center, 23% were asymptomatic despite contact with people with probable diagnostic of COVID-19; 29,4% reported mild symptoms, 43,9% moderate symptoms, and 3,7% severe symptoms. It was possible to observe in patients treated their symptoms of COVID-19 (group 3) with hydroxychloroquine and azithromycin for five days, presented statistically better improvement of the symptoms when compared to those that did not follow the protocol (p = 0.039). Three patients were hospitalized and discharged after recovery.
Conclusions
Our study showed that patients with COVID-19 who had delivery of health care through telemedicine initiated in early stages of the disease presented satisfactory clinical response, reducing the need of face-to-face consultations and hospitalizations. Our results indicate that the use of telemedicine with diagnosis and drug treatment protocols is a safe and effective strategy to reduce overload of health services and the exposure of healthcare providers and the general population to infected patients in a pandemic situation.
Trial registration
RBR-658khm
Human Research Ethics Committee number: 30246520.0.0000.0069
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SciScore for 10.1101/2021.11.05.21265569: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: After receiving all information about the study, patients accepting to participate in the project signed the informed consent, and all regulatory requirements for the execution of such a research in Brazil were met. Sex as a biological variable not detected. Randomization not detected. Blinding At this day patients were interviewed by a physician blinded to the other procedures of study just to apply the clinical improvement score. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources The data was recorded in a certified medical record DFMed, remotely accessed through AnyDesk platform and, posteriorly, tabulated and stored with Microsoft Excel 2003 … SciScore for 10.1101/2021.11.05.21265569: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: After receiving all information about the study, patients accepting to participate in the project signed the informed consent, and all regulatory requirements for the execution of such a research in Brazil were met. Sex as a biological variable not detected. Randomization not detected. Blinding At this day patients were interviewed by a physician blinded to the other procedures of study just to apply the clinical improvement score. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources The data was recorded in a certified medical record DFMed, remotely accessed through AnyDesk platform and, posteriorly, tabulated and stored with Microsoft Excel 2003 software. Microsoft Excelsuggested: (Microsoft Excel, RRID:SCR_016137)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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