My approach: 1) what are the (relative) effects of Plex on important outcomes? You might have to trust me on this but... Neutral on mortality, large relative reduction on kidney failure within 1 year, moderate - large increase on serious infection within 1 year. https://twitter.com/NephroGuy/status/1337108554172534786
How certain am I of those effects? Moderate for most.
No reasonable likelihood of effect on other outcomes
2) what are this patients risks of each outcome without plex? Death - moderate. Kidney failure - high (40% ish). Serious infection - high (let's say 40%)
No reasonable likelihood of effect on other outcomes
2) what are this patients risks of each outcome without plex? Death - moderate. Kidney failure - high (40% ish). Serious infection - high (let's say 40%)
3) What are the risks after Plex? Death - unchanged. Kidney failure - about 25%. Serious infection - about 50%.
So, likely Plex reasonable to pursue but be on high alert for serious infection.
So, likely Plex reasonable to pursue but be on high alert for serious infection.
4) why is this different than #Pexivas main results? Because we powered the trial for the composite believing death would be reduced in a similar way as kidney failure. We did not anticipate the potential counterbalance of serious infections
5) does the lung hemorrhage sway me? No. Plex appears to reduce kidney failure, not death. The lung hemorrhage is presumably a risk factor for death but not kidney failure so Plex unlikely to help (or equally likely to harm).
6) would a kidney biopsy help determine futility of added, potentially harmful, Plex? Probably not enough to sway decision making. Even biopsies with extreme sclerosis and interstitial fibrosis historically have a 20% chance of recovery.
Manuscripts to support this? Hopefully in public space soon.