Working Paper Article Version 3 This version is not peer-reviewed

Prospective Systematic Data Collection in Early COVID-19 Patients: A Protocol for Individualized Treatment and Outcomes Research

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, F. Prospective Systematic Data Collection in Early COVID-19 Patients: A Protocol for Individualized Treatment and Outcomes Research. Preprints 2020, 2020070529 Dantas, F. Prospective Systematic Data Collection in Early COVID-19 Patients: A Protocol for Individualized Treatment and Outcomes Research. Preprints 2020, 2020070529

Abstract

Human infection caused by the SARS-CoV-2 virus, called COVID-19, is a new pandemic with devastating effects worldwide. Science seeks the rational and systematic explanation of phenomena. In pandemics, decisions on prevention and treatment of people should be consistently taken, supported by scientific knowledge and ethical principles to produce more good than harm. At first, prospective observational studies to systematically collect patient data, correlating protective or therapeutic interventions with outcomes to assess effectiveness and safety, should be prioritized as the most appropriate type of study. The proposed protocol in this article aims to provide doctors with information on the reduction of harm in early COVID-19 patients by applying individualized interventionist or expectant therapeutic strategies, respecting the autonomy and preferences of physicians and patients in clinical decision-making. The evaluation of the clinical status, besides laboratory confirmation of COVID-19, comprises an individualized symptom score for each patient, a global self-perception scale of the severity of the disease, a clinical progression scale developed by the WHO for clinical studies in COVID-19 and, at the first consultation, doctors´ overall impression on the clinical prognosis. The analysis of anonymized data should preferably use descriptive and inferential statistical resources. The case report form is available for free use in the protocol, along with examples of patient informed consent forms for the prescription of off-label medications and authorization to use the data. Their results may be useful to indicate interventions that are candidates for efficacy trials, in randomized controlled trials, with a higher chance of success. It respects the autonomy and preferences of doctors and patients to decide the best options for treatment in uncertain situations. It also allows the gathering of useful information for future more rigorous clinical trials, trying to link science, ethics, and personal clinical experience.

Subject Areas

COVID-19; Treatment outcome; Data Collection; Pharmaceutical Preparations; Outcome Assessment; Health Care

Comments (1)

Comment 1
Received: 4 September 2020
Commenter: Flávio José Dantas de Oliveira
Commenter's Conflict of Interests: Author
Comment: 1. Mention to guideline 10 on health-related research involving Humans by the Council for International Organizations of Medical Sciences in collaboration with WHO, which opens the possibility that the research ethics committee may approve a modification or waiver of informed consent to research (sub-section Ethics].
2.Inclusion of possible hidden bias or systematic bias that could undermine the confidence in RCTs or science as a whole [section Introduction]
3. Alert on double standards in medical research, from planning to publication, exploring more clearly the Brazilian chloroquine RCT done in critically ill COVID-19 patients.
4. Comment on the pillars of Evidence-Based Medicine [Section Discussion]
5. Grammatical corrections and small changes to improve clarity in the text.
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