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The Rise of Medical Evidence

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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 (http://zidbits.com/2010/12/can-you-survive-a-freefall-without-a-parachute/), 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 (http://www.who.int/mediacentre/factsheets/who104/en/print.html), how does one determine if a treatment is effective? In this talk, I will examine how we gained knowledge about tuberculosis as an example of a disease where a combination of observational scientific findings and clinical trial data are linked to advance knowledge. I will also discuss other examples of clinical trials challenges and the solutions to these challenges.

Published in: Health & Medicine
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The Rise of Medical Evidence

  1. 1. Blood Sugar Control in the ICU
  2. 2. 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)
  3. 3. Proc Annu Symp Comput Appl Med Care. 1991:554-8. 6.9 7.8 mmol/L
  4. 4. Ann Thorac Surg 1999;67:352–62 Deep sternal wound infection 11.1 mmol/L
  5. 5. 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
  6. 6. Mean Glucose Levels 5.7 mmol/L 8.5 mmol/L Intensive Conventional Mean difference=50 mg/dl
  7. 7. Major Outcomes p<.04 p<.01 About 750 patients/group
  8. 8. ORIGINALITY IMPORTANCE QUALITY VALIDITY
  9. 9. Large multi-center trial started NICE SUGAR
  10. 10. Primary outcome 90 Day mortality Leuven #1-Published Nov 2001
  11. 11. 2001 to 2009 Control of blood glucose in the ICU became a quality measure
  12. 12. ENDOCRINE PRACTICE Vol 10 No. 1 January/February 2004
  13. 13. Intensive Care Med. 2008 Jun;34(6):1160-2
  14. 14. Along the Way Mixed results, possible harm
  15. 15. P=0.40
  16. 16. ORIGINALITY IMPORTANCE QUALITY VALIDITY
  17. 17. 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
  18. 18. Mean difference=35 mg/dl
  19. 19. All-Cause Mortality
  20. 20. ORIGINALITY IMPORTANCE QUALITY VALIDITY
  21. 21. N Engl J Med. 2010 Dec 23;363(26):2540-6.
  22. 22. JAMA Intern Med. 2015;175(5):801-809.

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