3 ms·
True, but it would reflect real experiences of patients having the respective procedures done under normal conditions by ordinary surgeons, rather than under tr
by Merrill 7y ago
True, but it would reflect real experiences of patients having the respective procedures done under normal conditions by ordinary surgeons, rather than under trial conditions. If there is a big difference in real world clinical outcomes, it would be evidence for the need for a new study.
The 2016 report is free (including supplementary appendix) at https://www.nejm.org/doi/10.1056/NEJMoa1610227 https://www.nejm.org/doi/10.1056/NEJMoa1610227 The appendix includes an extensive list of trial participants and institutions. It was a global study.
The 2019 report with 5-year outcomes is at https://www.nejm.org/doi/10.1056/NEJMoa1909406 https://www.nejm.org/doi/10.1056/NEJMoa1909406