The Uncertainty of Medical Evidence in Critical Care: Jeff Drazen
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The Uncertainty of Medical Evidence in Critical Care: Jeff Drazen
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Jeff Drazen delivers a powerful message on the use of medical evidence in critical care. Medicine is powered by knowledge, but how do we know what is true and what is not? How do we deal with uncertainty in a setting where outcomes are not closely related to known variables? For example, although there are a few people who have survived jumping or falling from an airplane at high altitude, it is a rare event. Thus, a test to determine how to prevent death from such a disaster would only take a small number of participants to see if a particular method works. In contrast, when considering a medical condition where a large fraction of people might seemingly “recover” without treatment, such as tuberculosis, how does one determine if a treatment is effective? In this talk Jeff discusses the trials surrounding blood glucose control in the Intensive Care Unit (ICU). The way we have dealt with increased blood sugar levels in critical care has changed over time. Whereas once upon a time there was little thought given to high blood sugar levels, this changed in the 90s. One single centre paper was the catalyst for a move toward tighter glucose control for patients in ICU. Due to the novel question and well-designed study, this paper was published in a prestigious journal – even if there were questions surrounding its validity. Larger, multi-centred papers were not published until many years later due to normal logistical and financial constraints. In the interim, the initial data had informed policy. Therein lies the problem. Join Jeff as he highlights the benefits and potential pitfalls in medical research by telling the story of tight blood glucose control in the ICU. For more like this, head to our podcast page. #CodaPodcast
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The Uncertainty of Medical Evidence in Critical Care: Jeff Drazen
- Blood Sugar Control in the ICU
- Before 2001 It was routine to ignore blood glucose levels of 200 mg/dL (11.1 mmol/L) Concern mounted when the blood sugar topped 250 mg/dl (14.2 mmol/L) Action was likely when the blood sugar 300 mg/dl (16.8 mmol/L)
- Proc Annu Symp Comput Appl Med Care. 1991:554-8. 6.9 7.8 mmol/L
- Ann Thorac Surg 1999;67:352–62 Deep sternal wound infection 11.1 mmol/L
- Single Center – Surgical ICU Outcome: Death in ICU Various secondary outcomes Target = 80-110 mg/dl n=765 Target = 180-200 mg/dl n= 783 Continuous Glucose Monitoring and Control Admit to SICU
- Mean Glucose Levels 5.7 mmol/L 8.5 mmol/L Intensive Conventional Mean difference=50 mg/dl
- Major Outcomes p<.04 p<.01 About 750 patients/group
- ORIGINALITY IMPORTANCE QUALITY VALIDITY
- Large multi-center trial started NICE SUGAR
- Primary outcome 90 Day mortality Leuven #1-Published Nov 2001
- 2001 to 2009 Control of blood glucose in the ICU became a quality measure
- ENDOCRINE PRACTICE Vol 10 No. 1 January/February 2004
- Intensive Care Med. 2008 Jun;34(6):1160-2
- Along the Way Mixed results, possible harm
- P=0.40
- ORIGINALITY IMPORTANCE QUALITY VALIDITY
- Multicenter – All ICU types Outcome: Death in 90 days Various secondary outcomes Target = 80-108 mg/dl n=3054 Target = < 180 mg/dl n= 3050 Continuous Glucose Monitoring and Control Admit to ICU
- Mean difference=35 mg/dl
- All-Cause Mortality
- ORIGINALITY IMPORTANCE QUALITY VALIDITY
- N Engl J Med. 2010 Dec 23;363(26):2540-6.
- JAMA Intern Med. 2015;175(5):801-809.
Editor's Notes
- Shabot MM, Bjerke HS, LoBue M, Leyerle BJ. Quality assurance and utilization assessment: the major by-products of an ICU clinical information system. Proc Annu Symp Comput Appl Med Care. 1991:554-8. PubMed PMID: 1807663; PubMed Central PMCID: PMC2247593.
- Continuous Intravenous Insulin Infusion Reduces the Incidence of Deep Sternal Wound Infection in Diabetic Patients After Cardiac Surgical Procedures. This study gave rise to the Portland Protocol
- The guidelines from the organizations listed are available online: American Association of Clinical Endocrinologists and American Diabetes Association, www.aace.com/pub/pdf/guidelines/InpatientGlycemicControlConsensusStatement.pdf; Surviving Sepsis Campaign, www .survivingsepsis.org/About_the_Campaign/Documents/SSC%20Statement%20on%20Glucose%20Control%20in%20Severe%20Sepsis.pdf; Institute for Healthcare Improvement, www.ihi.org/IHI/Topics/CriticalCare/IntensiveCare/Changes/ImplementEffectiveGlucoseControl.htm; American Heart Association, http://circ.ahajournals.org/cgi/content/short/117/12/1610; and European Society of Cardiology and European Association for the Study of Diabetes, www.easd.org/easdwebfiles/homepage/escandeasdguidelines.pdf. † The Normoglycemia in Intensive Care Evaluation–Survival Using Glucose Algorithm Regulation (NICE-SUGAR) trial is reported by Finfer et al.13 ‡ The guideline recommends “strict blood glucose control with intensive insulin therapy” and refers to studies in which such therapy has target glucose levels of 80 to 110 mg per deciliter (4.4 to 6.1 mmol per liter).