This is our primary end point: Clinical Improve
Post# of 153905
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Posted On: 08/11/2020 10:56:17 AM
This is our primary end point:
These are some of our Secondary end-points:
So ... below some copy-and-paste
https://www.cebm.net/covid-19/should-we-use-t...mary-care/
https://www.mdcalc.com/national-early-warning-score-news-2
NEWS uses six physiological measurements: respiratory rate; oxygen saturation; temperature; systolic blood pressure; heart rate and level of consciousness. Each scores 0–3 and individual scores are added together for an overall score. An additional two points are added if the patient is receiving oxygen therapy. The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk. Higher scores indicate the need for escalation, medical review and possible clinical intervention and more intensive monitoring.
NEWS2 was released in 2017.7 This measured the same six physiological measures but the layout of the chart was changed to align with the Resuscitation Council (UK) ABCDE sequence.8 The section for recording the rate of oxygen and the device used has been improved. The section measuring level of consciousness has added ‘new confusion’ (which includes disorientation, delirium or any new alteration to mentation) to the AVPU score, which becomes ACVPU (where C represents confusion). The importance of considering serious sepsis in patients with known or suspected infection, or at risk of infection, is emphasized.
Patients in the leronlimab group were more than twice as likely to experience a beneficial improvement in scores compared to patients in the placebo group (50% vs 20%; p=0.0223).
What does this mean ??? imho that we are better when treating moderate patients than mild patients . The NEWS2 score includes the temperature (fever) and the dyspnea term in which it measures oxygen saturation (arguably lower than normal if one has dyspnea). Our primary end point measures this as well as cough and muscle pain.
In essence, the NEWS2 score will differentiate a more a severe patient as compared to a mild one. And we got a statistical significant p-value !!!!
This is big. As a matter of fact, Lopinavir–Ritonavir (Abbott, Abbvie) used the NEWS 2 score for their (failed) SEVERE trial:
https://www.nejm.org/doi/pdf/10.1056/NEJMoa20...Tools=true
Quote:
Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) [ Time Frame: Day 14 ]
Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3. [0=none, 1=mild, 2=moderate, and 3=severe]. Higher scores mean a worse outcome.
These are some of our Secondary end-points:
Quote:
Time to clinical resolution (TTCR) [ Time Frame: Day 14 ]
Change from baseline in National Early Warning Score 2 (NEWS2) [ Time Frame: Days 3, 7, and 14 ]
This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). Higher scores mean a worse outcome.
So ... below some copy-and-paste
https://www.cebm.net/covid-19/should-we-use-t...mary-care/
https://www.mdcalc.com/national-early-warning-score-news-2
NEWS uses six physiological measurements: respiratory rate; oxygen saturation; temperature; systolic blood pressure; heart rate and level of consciousness. Each scores 0–3 and individual scores are added together for an overall score. An additional two points are added if the patient is receiving oxygen therapy. The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk. Higher scores indicate the need for escalation, medical review and possible clinical intervention and more intensive monitoring.
NEWS2 was released in 2017.7 This measured the same six physiological measures but the layout of the chart was changed to align with the Resuscitation Council (UK) ABCDE sequence.8 The section for recording the rate of oxygen and the device used has been improved. The section measuring level of consciousness has added ‘new confusion’ (which includes disorientation, delirium or any new alteration to mentation) to the AVPU score, which becomes ACVPU (where C represents confusion). The importance of considering serious sepsis in patients with known or suspected infection, or at risk of infection, is emphasized.
Patients in the leronlimab group were more than twice as likely to experience a beneficial improvement in scores compared to patients in the placebo group (50% vs 20%; p=0.0223).
What does this mean ??? imho that we are better when treating moderate patients than mild patients . The NEWS2 score includes the temperature (fever) and the dyspnea term in which it measures oxygen saturation (arguably lower than normal if one has dyspnea). Our primary end point measures this as well as cough and muscle pain.
In essence, the NEWS2 score will differentiate a more a severe patient as compared to a mild one. And we got a statistical significant p-value !!!!
This is big. As a matter of fact, Lopinavir–Ritonavir (Abbott, Abbvie) used the NEWS 2 score for their (failed) SEVERE trial:
https://www.nejm.org/doi/pdf/10.1056/NEJMoa20...Tools=true
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