Version 1
: Received: 20 July 2020 / Approved: 22 July 2020 / Online: 22 July 2020 (11:59:01 CEST)
Version 2
: Received: 29 July 2020 / Approved: 31 July 2020 / Online: 31 July 2020 (10:14:59 CEST)
Version 3
: Received: 1 September 2020 / Approved: 4 September 2020 / Online: 4 September 2020 (10:12:02 CEST)
How to cite:
Dantas de Oliveira, F.J. Prospective Systematic Data Collection in Early COVID-19 Patients: A Protocol for Individualized Treatment and Outcomes Research. Preprints2020, 2020070529. https://doi.org/10.20944/preprints202007.0529.v1
Dantas de Oliveira, F.J. Prospective Systematic Data Collection in Early COVID-19 Patients: A Protocol for Individualized Treatment and Outcomes Research. Preprints 2020, 2020070529. https://doi.org/10.20944/preprints202007.0529.v1
Dantas de Oliveira, F.J. Prospective Systematic Data Collection in Early COVID-19 Patients: A Protocol for Individualized Treatment and Outcomes Research. Preprints2020, 2020070529. https://doi.org/10.20944/preprints202007.0529.v1
APA Style
Dantas de Oliveira, F.J. (2020). <strong>Prospective Systematic Data Collection in Early COVID-19 Patients: A Protocol for Individualized Treatment and Outcomes Research</strong>. Preprints. https://doi.org/10.20944/preprints202007.0529.v1
Chicago/Turabian Style
Dantas de Oliveira, F.J. 2020 "<strong>Prospective Systematic Data Collection in Early COVID-19 Patients: A Protocol for Individualized Treatment and Outcomes Research</strong>" Preprints. https://doi.org/10.20944/preprints202007.0529.v1
Abstract
Human infection caused by the SARS-CoV-2 virus (COVID-19) is a new pandemic disease with devastating effects worldwide. There is no scientifically proved effective prophylaxis or treatment in the early phase of the disease. To prevent harm, In parallel with the running of randomized controlled trials, there is room for developing prospective systematic data collection studies correlating therapeutic measures with safety and effectiveness outcomes, on the assumption that a medical practice is effective if it produces more good than harm. The protocol aims to provide doctors with information on reduction of harm in early COVID-19 patients by different and individualized strategies for treating them, including comparison with no treatment strategies. Besides laboratory confirmation of COVID-19, the evaluation of the clinical status is done with an individualized symptom score for each patient, self-perception of overall severity of disease, clinical improvement ordinal scale developed for WHO clinical studies on COVID-19 and doctors´ global impression on clinical prognosis at the first consultation and evolution at the closing. It respects the autonomy and preferences of doctors and patients to decide the best options for treatment in uncertain situations and allows the gathering of useful information for future more rigorous clinical trials, trying to link science, ethics, and personal clinical experience. A case report form was developed that could easily be built in free software platforms as well as dedicated platforms. All data are anonymized and could be analyzed by descriptive and inferential statistics.
Keywords
COVID-19; Treatment outcome; Data Collection; Pharmaceutical Preparations; Outcome Assessment, Health Care
Subject
Biology and Life Sciences, Virology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
