154 Chapter 7 References 1. FDA. Guidance for industry-COVID-19: Developing drugs and biological products for treatment or prevention. (2020). 2. WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection. A minimal common outcome measure set for COVID-19 clinical research. The Lancet Infectious Diseases 20, 192–197 (2020). 3. Dodd, L. E. et al. Endpoints for randomized controlled clinical trials for COVID-19 treatments. Clinical trials (London, England) 17, 472–482 (2020). 4. Horby, P. et al. Effect of hydroxychloroquine in hospitalized patients with covid-19. The New England journal of medicine 383, 2030–2040 (2020). 5. Beigel, J. H. et al. Remdesivir for the treatment of covid-19 - final report. The New England journal of medicine 383, 1813–1826 (2020). 6. Davoudi-Monfared, E. et al. A randomized clinical trial of the efficacy and safety of interferon beta-1a in treatment of severe COVID-19. Antimicrobial agents and chemotherapy 64, (2020). 7. Cao, B. et al. A trial of lopinavir-ritonavir in adults hospitalized with severe covid-19. The New England journal of medicine 382, 1787–1799 (2020). 8. Abani, O. et al. Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): A randomised, controlled, open-label, platform trial. The Lancet 397, 1637–1645 (2021). 9. Horby, P. et al. Dexamethasone in Hospitalized Patients with Covid-19 Preliminary Report. New England Journal of Medicine (2020) doi:10.1056/NEJMoa2021436. 10. Abani, O. et al. Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): A randomised, controlled, open-label, platform trial and updated meta-analysis. The Lancet 400, 359–368 (2022). 11. Docherty, A. B. et al. Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: Prospective observational cohort study. BMJ 369, (2020). 12. Knight, S. R. et al. Risk stratification of patients admitted to hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: Development and validation of the 4C Mortality Score. BMJ 370, m3339 (2020). 13. Barbaro, R. P. et al. Extracorporeal membrane oxygenation support in COVID-19: An international cohort study of the Extracorporeal Life Support Organization registry. The Lancet 396, 1071– 1078 (2020). 14. Kwack, W. G. et al. Evaluation of the SpO2/FiO2 ratio as a predictor of intensive care unit transfers in respiratory ward patients for whom the rapid response system has been activated. PloS one 13, e0201632 (2018). 15. Brown, S. M. et al. Nonlinear Imputation of Pao2/Fio2 From Spo2/Fio2 Among Patients With Acute Respiratory Distress Syndrome. Chest 150, 307–313 (2016). 16. Brown, S. M. et al. Nonlinear Imputation of PaO2/FIO2 From SpO2/FIO2 Among Mechanically Ventilated Patients in the ICU: A Prospective, Observational Study. Critical Care Medicine 45, 1317–1324 (2017). 17. Chang, E. M., Bretherick, A., Drummond, G. B. & Baillie, J. K. Predictive validity of a novel noninvasive estimation of effective shunt fraction in critically ill patients. Intensive Care Medicine Experimental 7, (2019). 18. Buyse, M., Saad, E. D., Burzykowski, T., Regan, M. M. & Sweeney, C. S. Surrogacy beyond prognosis: The importance of “trial-level” surrogacy. The Oncologist 27, 266–271 (2022). 19. Saha, R. et al. Estimating the attributable fraction of mortality from acute respiratory distress syndrome to inform enrichment in future randomised clinical trials. Thorax (2023) doi:10.1136/ thorax-2023-220262. 20. Carvalho, E. B. de et al. Rationale and limitations of the Spo2/FIO2 as a possible substitute for PAO2/fio2 in different preclinical and clinical scenarios. Revista Brasileira de terapia intensiva (2022). 21. Ferguson, N. D. et al. The berlin definition of ARDS: An expanded rationale, justification, and supplementary material. Intensive care medicine 38, 1573–82 (2012). 22. Borm, G. F., Fransen, J. & Lemmens, W. A. J. G. A simple sample size formula for analysis of covariance in randomized clinical trials. Journal of clinical epidemiology 60, 1234–8 (2007).
RkJQdWJsaXNoZXIy MTk4NDMw