It's really important to be careful in the language I use, and if I left misconceptions, I apologize.
I'm sure not all of my answers will satisfy everyone -- but a great starting point here would be to remember we are in an "improvement" mode with sepsis care nationally now, and that science and evidence is part of that process, but much improvement in care moves in ways that only compliments science and best evidence, but does not derive strictly from it. I have great appreciation for many of your ideas and thoughts below. To your specific points...see below... On Sep 15, 2015, at 9:31 AM, Allen, Gilman B <[email protected]<mailto:[email protected]>> wrote: Sean, I attended your webinar on Sepsis Core measures last week and was left with a number of concerning questions: 1. If we are using the logic that “there is no evidence to show it doesn’t hurt” to justify follow-up physical exam measures for evaluation of response to resuscitation, then why does the same logic not apply to the use of Normsol and other chloride-balanced crystalloids? I would argue that there is a growing body of evidence that normal saline may indeed “hurt” (JAMA. 2012;308(15):1566-1572.; Br J Surg 102 (1):24-36. Crit Care Med 2014; 42:1585–1591. ***Yes, maybe, but I haven't seen a body of evidence that we should all live normsol? I also haven't seen sophisticated trials comparing a lot of this head to head. I have seen 4 large trials in septic shock that premise their results in use of saline -- Rivers and the three new trials in NEJM. Personally I'm not invested in this much, and to the extent I could loosen choice if resuscitation fluids and remain consistent with international guidelines, I'm happy to advocate for that. I'm not sure on a macro level this debate is a big driver of mortality in septic shock, so you really think the treatment effect here is large enough to be worried about this? I'm asking -- I'm thinking its minor.*** 2. In defending the use of many of these unproven metrics of volume responsiveness and distal perfusion, you described many of these measures as a “proxy” measure of “attentive evaluation” and intensive care. I full agree, and practice this way. I believe these measures help represent a collective epi-phenomenon of intensive and regimented care. Using the same reasoning, why then is there no provision in any of this for providers to document their own rationale for diverging from some of these restrictive mandates when judged to be clinically justified. Is this not also a worthy “proxy” of intensive and attentive care? ***I guess simply said you have to have some standard for measurement purposes even if you are willing to practice in a way where you feel you are gathering much information and making informed decisions. I would hope that the expanded palette of choices you have here helps you to have freedom from the previous hegemony of cvp and scvo2. There's lots of choice. But unless there's some standard I can't measure and if I can't measure I cannot improve.*** 3. When does the clock really start ticking? Our hospitals still don’t have a solid and reliable answer to this question. Is it when the physician documents their suspicion of sepsis, 3 hours after a fever and hypotension? When blood cultures are first ordered one hour after the fever? Or when an MD orders Tylenol, a CBC, lactate, and blood cultures on someone he/she suspects may be either bleeding, in pain, or possibly infected post-Op? When do these types of patients really “declare” themselves septic. ***Here, it will be hard for docs. As a doc, you can always start the clock by documenting severe sepsis is present with a time stamp. That's always your choice and the data abstractors are expected to obey that. If you don't, they are going to pull from assorted documentation -- flow sheets nursing mutes, lab reports -- to build the time all elements of severe sepsis were present.*** The efforts to try to “capture” every element of Goal-directed care in an “all-or-none” pass/fail algorithm dooms itself from the beginning. Why didn’t CMS just start off with the 3 hour bundle, monitor how others do with the 6 hour bundle, and try to figure out where (and why) their algorithm is succeeding, or failing, to capture (and enforce) best practice? ***There were a number of reasons this didn't happen, going back to the time ProCESS was published and public hearings were happening at the NQF. Part of the answer is that processes of care up to 6 hours were important in the control and intervention arms. Another part is that the vote to suspend EGDT at NQF as a strategy was actually not without a large minority that still supported hemodynamics assessment despite the findings of the new trials 13-9 (I believe) was the vote to reject EGDT as a requirement. Basically things moved fast, people wanted choices, 6 hours was thought to be important. Since EGDT was not inferior to usual care, choice prevailed.*** I’ve augured to my group that there is absolutely no excuse for not getting blood cultures, a lactate, and fluids on board within one hour of a high suspicion of sepsis. This is a low bar we should all be meeting, but probably aren’t. Why not simply start there, and work our way forward? ***I can say that it might have been a better choice in retrospect. However, I am excited that we will have observational data on millions of patients that tell us about the effect of the choices now provided in the 6 hour strategy. Those results with that N should be fascinating in years to come.*** Gilman B. Allen, MD Associate Professor Department of Medicine Director of Adult Critical Care Services University of Vermont / Fletcher Allen Healthcare HSRF 220, 149 Beaumont Ave Burlington, VT 05405-0075 (802)656-9004 Fax: (802) 656-8926 [email protected]<mailto:[email protected]> [cid:[email protected]]
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