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Evidence, Epistemology,Equipoise and Pediatric Trauma

Evidence, Epistemology,Equipoise and Pediatric Trauma. Craig Downs, MS, DO; FACEM, FAAP, FACOP, FCCM Assistant Professor, Child Health Pediatric Critical Care University of Missouri-Columbia Columbia, Missouri. 1. Evidence, Epistemology, Equipoise and Pediatric Trauma.

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Evidence, Epistemology,Equipoise and Pediatric Trauma

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  1. Evidence, Epistemology,Equipoise and Pediatric Trauma • Craig Downs, MS, DO; FACEM, FAAP, FACOP, FCCM • Assistant Professor, Child Health • Pediatric Critical Care • University of Missouri-Columbia • Columbia, Missouri 1

  2. Evidence, Epistemology, Equipoise and Pediatric Trauma • And How Pediatric Critical Care Happens to be intertwined in all the Above • Why we should Talk About These Things • And What we Should Expect when we “look” at the “Evidence” • And How we consider each patient in a complete, autonomous way • And How we can pass all we “know” along to those who really need to “know” • And If we can really maintain “Balance” in our Decisions • And How we can use what we know to always improve all our patient outcomes 2

  3. Evidence, Epistemology, Equipoise and Pediatric Trauma • Definitions: • Evidence: First an example: • In 1988 there were 350,000 cases of Polio worldwide. In 2012, there were 223. (This is Evidence: Grade 1; Class 1: FACT) • Getting to Zero cases is likely to require spending billions of Dollars (US) and going to remote regions of the World, confronting Taliban Militants to get to the last unprotected Children on Earth. (This is conjecture, dream or what have you: sometimes called opinion; and is not subject to a test of any type; not an RCT or otherwise) 3

  4. Evidence, Epistemology, Equipoise and Pediatric Trauma • “To see the world in a grain of sand, • And a heaven in a wild flower • hold infinity in the palm of your hand • and eternity in an hour” W. Blake • Since Time before Time, Children have been left on the streets, in closets, chained to work places and otherwise debased. They have been Abused, Tortured, Killed and Abandoned. • In the late 1800’s and early 1900’s, Children were considered Property and were bought and sold. • Trauma remains the Largest Killer of Children ages: 1-17, thus, it behooves us to witness and stop this Epidemic 4

  5. Evidence, Epistemology, Equipoise and Pediatric Trauma • Estimate of the cost of Childhood Trauma: • $357 Billion per year • $257 Billion per year in lost quality of life • 15% of all Medical Spending due to Trauma • 95% of serious head injuries due to AHT • AHT requires intense investigation without prejudice • AHT mortality: 15-38% and morbidity high 5

  6. Evidence, Epistemology, Equipoise and Pediatric Trauma • Children change—this is not something new—throughout their days. However, the maxim: “Children are just little Adults” vastly debases Children and All those who Do and Would Provide Medical Care to and for Children. • “Could there be any better way to get my nose rubbed in the truth of impermanence than to love a child in a jagged, careless world? and even if everything goes absolutely perfectly, I know that this particular Skye—the one who warbles and passionately sucks on the bill of his rubber duck as he splashes with me in the tub—is going to dissolve like bubble bath. Yesterday he was kicking bulge in my belly as I swam laps in the July sun; tomorrow he’ll be a middle-aged man, weeping and scattering my ashes in a mountain lake” Anne Cushman, Buddhist writer and mother. 6

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  8. Evidence, Epistemology, Equipoise and Pediatric Trauma • Definition: EVIDENCE: • As used in the phrase: “Evidence-Based Medicine” • First used by Gordan Guyatt, 1991 • Evidence-Based Medicine, ACP Journal Club, 1991, Volume: 114; (Supplement. 2); A16; Guyatt, G. • In 2001: The New York Times judged EBM as the idea of the year with respect to the procurement of knowledge in Medicine. 8

  9. Evidence, Epistemology, Equipoise and Pediatric Trauma • History of EBM: • 1972: Archie Cochrane, director of the Medical Research Council Epidemiology Research Unit in Cardiff, Wales publishes: Effectiveness and Efficiency: Random Reflections on Health Services • Late 1980s/early 1990s: Guyatt and David Sackett from Toronto; and David Eddy from Duke begin publishing additional works. • Basic Premise (at the start/since severely modified): we should treat where there is evidence of benefit and not treat where there is evidence of no benefit (or harm). 9

  10. Evidence, Epistemology, Equipoise and Pediatric Trauma • There are other kinds of Evidence • Every Clinician Must be Aware • Fact: and these Facts may change, and the “Truth” may be altered. • Legal 10

  11. Evidence, Epistemology, Equipoise and Pediatric Trauma • About the Legal: • Anything presented in support of an assertion • May be strong or weak • Strong: Provides direct Proof of the Truth of an assertion • Weak: Consistent, but does not rule out other, even contradictory assertions (circumstantial evidence) 11

  12. Evidence, Epistemology, Equipoise and Pediatric Trauma • About the Scientific: (Medical—sometimes) • Observations and Experiments • May support, refute or modify • Develop Theory • Develop Hypothesis 12

  13. Evidence, Epistemology, Equipoise and Pediatric Trauma • In Philosophy: • Evidence is tied to Epistemology • Epistemology is the study of the nature of knowledge: suppositions, conclusions and all that happens in between—how we know things; the structure of knowledge itself • From the Greek: Episteme: Knowledge • Thus: “what” we “know”; “how” we “know” and “why” we “know” all become important in understanding Evidence 13

  14. Evidence, Epistemology, Equipoise and Pediatric Trauma • Definition: Equipoise: • Equipoise, and Clinical Equipoise provide the ethical basis for medical research involving patients assigned to different treatment arms of a clinical trial. Clinical Equipoise was first used by: • Benjamin Freedman: NEJM; 1987 in: Special Article: Equipoise and the Ethics of Clinical Research; New England Journal of Medicine; vol. 317; No. 3; pages: 141-145 14

  15. Evidence, Epistemology, Equipoise and Pediatric Trauma • One Part of New Paradigm of EBM was to eliminate the “Expert”. This was part of the very early days of EBM, and has since been the source of intense and voluminous discussion. Subsequently, EBM has recognized “Expert” in the grading system, although at the lowest level of “evidence” • Why this is a Problem: at the interface of Medicine and Law: the Daubert Standard: This “Standard” provides a rule of evidence regarding the admissibility of an “Expert” witness testimony in a US Federal Legal Proceeding. 15

  16. Evidence, Epistemology, Equipoise and Pediatric Trauma • The Daubert Trilogy: • 3 US Supreme Court cases: • Daubert v Merrell Dow: 1993; via Rule 702 of the Federal rules of Evidence, didn't incorporate general acceptance test. • General Electric Co v Joiner: a district court judge could exclude “expert” testimony when gaps existed between the evidence relied upon by an expert and his/her conclusion • Kumho Tire Co v Carmichael: 1999; the judges gatekeeping function identified in Daubert applies to all expert testimony, including that which is non-scientific. 16

  17. Evidence, Epistemology, Equipoise and Pediatric Trauma • What then is “Evidence”? • How can we “Experiment” Scientifically using Children so that we have epistemic awareness and proceed with Equipoise? • Axioms in philosophy are not axioms until they have proved upon our pulses; we read fine things but never feel them to the full until we have gone the same steps as the author. John Keats 17

  18. Evidence, Epistemology, Equipoise and Pediatric Trauma • Evidence and Equipoise have detractors • Miller, F.G. & Brody, H.; A Critique of Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical Trials; The Hastings Center Report; 2003; 33 (3); 19-28 • Veatch, R; The Irrelevance of Equipoise; Journal of Medical Philosophy, 2007, 32(2); 167-83 • Tonelli, M.R.; Integrating Clinical Research in Clinical Decision Making; New Challenges in Translational Medicine, 2011, 47(1); 26-30 • Zoccali, C.; Evidence-based medicine: The Clinician’s Perspective; Nephrology, Dialysis and Transplantation; 1999; 14(suppl. 3); 42-45 18

  19. Evidence, Epistemology, Equipoise and Pediatric Trauma • Vaclev Havel • “It is I who Must Begin” 19

  20. Evidence, Epistemology, Equipoise and Pediatric Trauma 20

  21. Evidence, Epistemology, Equipoise and Pediatric Trauma • What I would like to Indicate: • “When I use a word,” Humpty Dumpty said in rather a scornful tone, “it means just what I choose it to mean—neither more nor less.” • “The question is,” said Alice, “whether you can make words mean so many different things”“The question is,” said Humpty Dumpty, “which is to be master— That’s all” • (Through the Looking Glass: Chapter 6) 21

  22. Evidence, Epistemology, Equipoise and Pediatric Trauma • In general, we believe: • EBM has Value and Non-value • Using EBM requires Equipoise • “To show that the optimal practice of clinical medicine, though requiring the knowledge of the results of clinical and bench research, demands that doctors thoughtfully consider both evidentiary and non-evidentiary warrants for action in each attempt to deliver the best care to a particular individual” Tonelli, MA; Integrating Evidence into Clinical Practice: an Alternative to Evidence-based Approaches: J. Eval. Clinical Practice; 2006, v.12 No. 3; 22

  23. Evidence, Epistemology, Equipoise and Pediatric Trauma • As One Example of How Things Change/are Impermanent: • “Renal Dose Dopamine: From Hypothesis to Paradigm to Dogma to Myth and, Finally, Superstition?” Jones, D and Bellomo, R; J. Intensive Care Medicine; 2004; accessed at: http://jic.sagepub.com/content/20/4/19 23

  24. Evidence, Epistemology, Equipoise and Pediatric Trauma • A Second Example: • “Revising a Dogma: Ketamine for Patients with Neurological Injury?’ Himmelseher, & Durieux; Anesth. Analg. 2005; vol. 101; pages: 524-534 • With These Two examples we begin to have an appreciation for: • Understanding what we “know” as Evidence • The Ethics of what we do because we “know” • The Loss of Equipoise that prevents us from doing further studies. 24

  25. Evidence, Epistemology, Equipoise and Pediatric Trauma • Medicine, Philosophy, and How we Think as Physicians are intimately related to the Actions we undertake for the Individual and Society. We must care for the Whole Person, as well as the Whole Society. Thus, any study, any source of Evidence, must add to our Epistemic Base, and each Therapy, when No Therapy is clearly superior to another, requires an Ethical Stance with Clinical, Systemic, and Research Equipoise. The Truth of Pediatric Critical Care and the Truth of the Care of the Pediatric Trauma Patient comes from Knowledge of Physiology, Pathophysiology, Anatomy, Biochemistry, the Sciences of Engineering, Physics, Cell Biology, Complex Systems and assorted others. 25

  26. Evidence, Epistemology, Equipoise and Pediatric Trauma • “Medicine and Philosophy oscillate about each other like strands of a complex double helix of the intellect. They are intermittently drawn together by their immersion in man’s preoccupations with that existence.” • “A central Problem in Technological Societies is the Judicious containment of the Expert.” • “A Philosophical Basis of Medical Practice; Towards a Philosophy and Ethic of the Healing Professions” E. Pelegrino and D. Thomasma; Oxford Press; 1981 26

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  28. Evidence, Epistemology, Equipoise and Pediatric Trauma • Vaclev Havel: “Education is the Ability to Perceive the Hidden Connections between Phenomena” 28

  29. Evidence, Epistemology, Equipoise and Pediatric Trauma • “Review Article: The Genetic predisposition to adverse outcome after Trauma” Giannoudis, PV; van Griensven, M; Tsiridis, E; Pape. HC; 2007; British: J. Bone Joint Surgery; 89B No. 10; October; pages: 1273-1279 • (From the Abstract): Technological advances and shorter rescue times have allowed early and effective resuscitation after trauma and brought attention to the host response to injury. This review examines the current evidence the genetic predisposition to adverse outcome after trauma. 29

  30. Evidence, Epistemology, Equipoise and Pediatric Trauma • Current Evidence indicates that the early SIRS response in Children and Adults following Trauma and/or major surgery is characterized by pro inflammatory cytokine release, microcirculatory disturbance, cell-mediated immune disfunction followed by a (sometimes over) compensatory response from the anti-inflammatory system which can predispose children (and adults) to opportunistic infection, multiple organ dysfunction syndrome and death. • Since about 2006; the vascular Endothelial Glycocalyx has been a subject of significant research. This lines the endothelium, changes the Starling Law, is altered significantly by trauma and resuscitation fluids and may be the “Next Big Thing” to target in critical care of children who have been subjected to trauma. 30

  31. Evidence, Epistemology, Equipoise and Pediatric Trauma • Trauma is the leading cause of Death in Infants and Children ages 1-14 in the USA • Head Injury: 38% of the overall injury burden • Motor Vehicle Trauma is the cause of most injuries • over 5000 traumatic Deaths per year in the US • Trauma causes 50% of Deaths ages 5-34 years • Over $16 Billion (>16,000,000,000) spent each year caring for children who are less than 16 years of age who sustain Traumatic Injuries 31

  32. Evidence, Epistemology, Equipoise and Pediatric Trauma • 30 million ED visits per year for children • Think about Alcohol in anyone over age: 12 years (various studies have found this to be a discriminator) (although it may change) • Don’t need to do a Rectal Exam in children unless there is a very specific reason, and then they should be sedated/or during another anesthesia event. (several studies; class 1/2 i.e. : good to very good evidence) • Think about Child Abuse and when you do; there must be (at the right time) a dilated Ophthalmologic Exam 32

  33. Evidence, Epistemology, Equipoise and Pediatric Trauma • Highest childhood in-hospital mortality after Trauma: Adult Hospitals with Pediatric Units: 2.4% • Lowest childhood in-hospital mortality after Trauma: Pediatric Hospitals: 0.9% • Think about suicide/attempted suicide when adolescent alone in MVC. • Think about Drugs of Abuse, as well as Drugs that are legal, and don’t show up on typical Toxicology screen • Think about Quality, Safety and Whole Family Care 33

  34. Evidence, Epistemology, Equipoise and Pediatric Trauma • Evidence: having the family present during resuscitation, trauma activation, or other significant events in the life of the child does not interfere with care; does provide appropriate family interactions, and does enable care givers and families to more completely understand each other.(published evidence from multiple family question/surveys and from interviews with physicians immediately after CPR events and such: NO RCT—how would you do it? does this mean that we can’t use this data?; and my own evidence from Pre-hospital to ED, Pediatric Units, and PICUs over the past 30 years; the first paper I read about this topic was published in 1979) 34

  35. Evidence, Epistemology, Equipoise and Pediatric Trauma • Quality Improvement Aspects: • Trauma System Organization • IMPACT study: a Prospective RCT • In-Hospital Care • Long-Term Care • Quality of Life • Family Burden • PTSD 35

  36. Evidence, Epistemology, Equipoise and Pediatric Trauma • Radiology Care: ALARA • Use CAT scan carefully • Use Radiographs Appropriately • Pediatric blunt trauma patients receive a major radiation burden in their initial evaluation, while children who are transferred from a first hospital endure an even higher dose of radiation. from: Evaluation of Radiation Exposure to Pediatric Trauma Patients: Tepper, B; Brice, JH; Hobgood, CD; The Journal of Emergency Medicine, vol. 44; No. 3; pages: 646-652 2013 36

  37. Evidence, Epistemology, Equipoise and Pediatric Trauma • More than 62 Million CAT scans/year in the US • More than 7 Million Pediatric CAT scans/year in the US • Pediatric Trauma patients receive an average dose of 12.8 mSv/trauma incident. 2009 statistics from Pediatric Academic Society. • 11.42 people will get radiation induced cancer for every 10,000 exposed to 10 mSv (NAS) • Pediatric population more sensitive by a factor of 3-10 37

  38. Evidence, Epistemology, Equipoise and Pediatric Trauma • In a 1 year old who has a CAT scan using typical adult CAT scan parameters: • Risk of Dying from Cancer: 1 in 550 after ONE abdominal CAT scan • Risk of Dying from Cancer: 1 in 1500 after ONE brain CAT scan • Estimated risks of radiation induced fatal cancer from Pediatric CT. ; AJR (Am J Roentgenol) 2001, Vol. 176; pages: 289-96; Brenner, D; Elliston, C; Hall, E.; Berdon, W 38

  39. Evidence, Epistemology, Equipoise and Pediatric Trauma • Radiation exposure from CT scans in Childhood and subsequent risk of Leukemia and Brain Tumors: A retrospective Cohort Study, Lancet, 2012 • 178,604 children age <22 yrs; 1998-2005 • No Cancer prior to first CT • 283,919 CT scans • Leukemia: 74 • Brain Tumor: 135 • If >30 mGy; RR leukemia: 3.18 • if >50 mGy: RR Brain Tumor: 2.82 39

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  46. Evidence, Epistemology, Equipoise and Pediatric Trauma • BRAIN TRAUMA • Recent Data: 1.7 million people with TBI/year: USA • Of Children aged: 0-14 Years of age • 474,000 ED visits per year • 35,000 Hospitalizations per year • 2,174 Deaths per year • cdc.gov/ncipc/tbi/coaches_tool_kit.htm 46

  47. Evidence, Epistemology, Equipoise and Pediatric Trauma • BRAIN TRAUMA • According to CDC estimates: 5.3 million Americans have long-term or life time need for help • From Concussion to Severe Brain Trauma may have many functional problems: • Thinking • Sensation • Language • Emotion 47

  48. Evidence, Epistemology, Equipoise and Pediatric Trauma • BRAIN TRAUMA: SUMMARY OF RECOMMENDED PRACTICE IN PICU • Allow Family Contact • Avoid Hyperglycemia • Avoid Hypercarbia • Avoid Hyperthermia • Avoid Hypothermia • Hyperosmolar Therapy • Prevent Seizures 48

  49. Evidence, Epistemology, Equipoise and Pediatric Trauma • BRAIN TRAUMA: SUMMARY OF RECOMMENDED PRACTICE IN PICU • Treat Pain and Agitation • Mid-line neck, 30 degree head elevation • Pentobarbital for severe/refractory ICP • Decompressive Craniectomy • EVIDENCE: None of the above has an RCT as evidence/proof but we do them, and it is likely that there would be no Equipoise to even do an RCT. 49

  50. Evidence, Epistemology, Equipoise and Pediatric Trauma • Mechanism of action: Hyperosmolar Agents: • Q = (πΔPr⁴)/(8νl) • Thus, both Mannitol and Hyperosmolar Saline reduce the ICP due to rheologic effects, and not osmotic diuresis. They both reduce blood viscosity, which allows for reduced vessel caliber while maintaining blood flow, represented by Poiseulle’s Law—as noted above. • If one is to discuss a therapy, one must know how it creates its action. 50

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