Hi Ryan, Very well reasoned and nicely said. I'm glad you made these points. The best thing about ProCESS is that we will have a long and open discussion about where we stand.
For the sake of pro/con, let me make a rejoinder. :-) 1. Jones et al. reflected a trial that did not tell us anything much about "usual care." The comparison was head to head EGDT using ScvO2 versus EGDT using lactate clearance as a substitute for ScvO2. Everyone had central lines in both arms. Everyone was resuscitated using CVP as a guide. 2. Jones et al. and ProCESS reflect care at academic centers. It may well be that the nation's elite centers that have enough interest to sign up investigators who care sufficiently to invest years of time into studying sepsis, residents and fellows monitoring resuscitation parameters around the clock, and well established standards and protocols achieve low mortality rates and high compliance rates with SSC guidelines. 3. Neither Jones nor ProCESS show low compliance with SSC guidelines results in great outcomes. On the contrary, the control arm in ProCESS approached 60% compliance with central access, and Jones had 100% compliance with current SSC bundles in both arms. 5. In ProCESS I can't tell you how to be like the control arm because frankly we just don't know how care was provided. A far as we can tell 60% of the control patients might have had the same therapy as the intervention. What does this mean? Nobody can say. 4. US hospitals just don't look like this care in thousands of hospitals across the country. Compliance with SSC bundles in the US is at best in the 30-40% range in hospitals that have been actively working on adherence for 2 years (Levy 2010). Mortality in that group if community hospitals is in the 28% range for severe sepsis and septic shock combined (shock is higher). The largest current database if US hospitals that compares mortality of all acute care discharges, Medicare and commercial coverage and no coverage combined, is the Midas Comparative Database. This database has 750 US hospitals, roughly 15% of all hospitals in the country. As of this month, the P50 shock mortality in this swath of hospitals is 32.5%. 5. I don't pretend to have all the answers yet. ProCESS is probably showing us that really awesome care short of the SSC bundles, reliably executed is pretty darn good. The public health dilemma and true danger of ProCESS is that the huge majority -- thousands of hospitals (there are around 5000 US hospitals) -- don't look like ProCESS. 6. If you can honestly say your own *shock* mortality is 18% -- ask the quality department at your system, they know -- and 60% of your patients get lines, and you have 24/7 intensivist coverage following these patients, well then I guess you look like ProCESS. The 26 hospitals in my system have none of that, each has shock mortality rates greater than 23% and some approaching 34%. One has 24/7 intensivist coverage, central line insertion rates are about 20%. 7. So, I'm not comfortable saying do whatever you like. I spend a lot of energy visiting hospitals across the country. For the public health we cannot let the message be relax your standards even below where they are now. I continue to say if you want to improve in your current state, aim high, set bold targets. The day you look like ProCESS you can pause and reflect on what to do next. :-) I think that's the positive message my colleagues and I need to get out there. The debate is good to have because it's a chance for us to raise awareness and focus people on what they can actually say about their own outcomes thus far. I really appreciate your intelligent and well made remarks, and I know this discussion is far from over! I've said the best day will come when a neutral objective 3rd party can make this statement. I'm invested as you know. Sean Sean R. Townsend, M.D. Vice President of Quality & Safety California Pacific Medical Center 2330 Clay Street, #301<x-apple-data-detectors://0/0> San Francisco, CA 94115<x-apple-data-detectors://0/0> email [email protected]<mailto:[email protected]> office (415) 600-5770<tel:(415)%20600-5770> fax (415) 600-1541<tel:(415)%20600-1541> On Mar 29, 2014, at 8:38 AM, "Ryan Arnold" <[email protected]<mailto:[email protected]>> wrote: I will suggest a counter to the observation that the PROCESS trial does not represent most US hospitals. We have 2 US-based studies now with ED-centered randomization and similar mortality rates. The smaller scale multi-centered RCT (Jones) and the larger scale multi-centered RCT (PROCESS) have near identical overall mortality rates to each other (Jones: overall mortality 59/300 = 19.7%; PROCESS: overall mortality 259/1341 = 19.3%). Each of these used identical inclusion criteria to the original EGDT study and identical inclusion criteria to current SSC guidelines. The other 2 studies mentioned in the same NEJM release did have higher mortality rates. However, they do not represent the same population as addressed in the Emergency Department-centered PROCESS study. The albumin in sepsis study (Caironi et al) is an Italian ICU based patient population with “severe sepsis or septic shock”, very different population than PROCESS or Rivers. The high vs low MAP target study (Asfar et al) is a French ICU-based patient population with vasopressor dependent septic shock, again, not the same population as the PROCESS or Rivers study. Even if ARISE and PROMISE reflect a different trend or outcome, from a US hospital perspective, PROCESS is as applicable if not more so for a US-based hospital system. From PROCESS, it would seem that there is change supported in current care: Mandated central line placement for all patients is unsupported (i.e. does not improve mortality). Mandated CVP assessment and ScvO2 assessment for all patients is unsupported (i.e. does not improve mortality). There is a high likelihood of a Hawthorne effect in the usual care arm, where the treatment team may have been more attentive and aggressive in resuscitation and monitoring knowing they were being “watched", which is the bottom-line message we all advocate for and seems to be important across the board: be attentive / be aggressive. The usual care care in Process was great care as was pointed out, timely fluids and antibiotics, central lines when indicated, and all this continues to support early recognition, aggressive up-front fluids, and early antibiotics. If central access is necessary to treat fluid refractory hypotension with vasopressors, I think a case can be made for assessment of both CVP and ScvO2 as they are valuable measures if low, but much less helpful, if at all, when normal. I think PROCESS will translate to an overall improvement in sepsis recognition and care, where clinicians are more likely to participate in sepsis resuscitation now that they are supported with a less-invasive alternative than is currently suggested. Ryan Ryan Arnold, MD Department of Emergency Medicine Christiana Care Health System Newark, DE _______________________________________________ Sepsisgroups mailing list [email protected]<mailto:[email protected]> http://lists.sepsisgroups.org/listinfo.cgi/sepsisgroups-sepsisgroups.org _______________________________________________ Sepsisgroups mailing list [email protected] http://lists.sepsisgroups.org/listinfo.cgi/sepsisgroups-sepsisgroups.org
