Working Paper Article Version 2 This version is not peer-reviewed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)

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 (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.

Subject Areas

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

Comments (1)

Comment 1
Received: 31 July 2020
Commenter: Flávio José Dantas de Oliveira
Commenter's Conflict of Interests: Author
Comment: 1.  A new assumption (vi.) was added on the accountability for both attitudes of skeptical empiricism and therapeutic nihilism  as well as physicians´ ethical responsibility in  obtaining informed consent from  patients  to collect their data for documentation [Proposal];
2. A mention was done to Clinimetrics as a conceptual framework in measuring the "art" of Medicine [Clinical protocol elements];
3. Addition of the three tenets of EBM [Discussion, 4th paragraph]
4. Usability of the protocol and iits associated form in publicly funded national healthcare systems [Discussion, 5th paragraph];
5. Need for individual empowering of physicians to become again protagonists in independently helping to build medical science [Discussion, 7th paragraph].
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