Evidence based medicine and neurotrauma (Medicina bazirna na činjenicama i neurotrauma)

1. Evidence based medicine and neurotrauma (Medicina bazirna na činjenicama i neurotrauma) Univ.Doc. Dr.Med. Martin Rusnak, CSc Int. Neurotrauma Research Organization Vienna, Austria http://www.igeh.org/ Sarajevo, Sept. 2003

2. Hippocrates “There are, in effect, two things, to know and to believe one knows; to know is science; to believe one knows is ignorance.” Sarajevo, Sept. 2003

3. Medical Mistakes • the National Institute of Medicine found that medical mistakes kill somewhere between 44,000 and 98,000 people (average: 71,000) in hospitals in the U.S. each year • on average, one out of every 500 people admitted to a hospital in the U.S. is killed by mistake • the chance of being killed in a commercial airline accident is one per 8 million flights Sarajevo, Sept. 2003

4. Healthcare Quality is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge Lohr KN, Harris-Wehling J. Medicare: a strategy for quality assurance. Quarterly Review Bulletin 1991;17,(1):6-9. Sarajevo, Sept. 2003

5. Improving Quality of HC • creativity and motivation among healthcare workers of all kinds; • leadership is an essential ingredient of success: senior managers feel personally responsible for each error; • the problem is not fundamentally due to lack of knowledge; we already know far more than we put into practice. Based on Lucian Leape and Donald Berwick: Safe health care: are we up to it? We have to be. Editorials BMJ 2000;320:725-726 ( 18 March ) Sarajevo, Sept. 2003

6. ISSUES • TBI - What are the problems? • TBI management strategies • Introduction into EBM • TBI treatment in reality • How to use EBM for continuous quality improvement in the care of TBI patients Sarajevo, Sept. 2003

7. TBI: Treatment Goals • TO KEEP THE PERMANENT NEURO DEFICIT AT THE LEVEL DEFINED BY THE PRIMARY INJURY • TO AVOID COMPLICATIONS • TO RECOGNIZE IMMEDIATELY • TO TREAT WITHOUT DELAY SECONDARY BRAIN INSULTS Sarajevo, Sept. 2003

8. Secondary Brain Insults • HYPOTENSION (SAP < 90) • HYPOXIA (paO2 < 60, SaO2 < 92) • GLOBAL ISCHEMIA (CI < 2, CPP < 50) • REGIONAL ISCHEMIA (vasospasm) • ANEMIA (Hct < 30, Hb < 10) • HYPERCARBIA (pCO2 > 40) • HYPERTHERMIA (BT > 37.5) Chesnut RM, New Horizons 1995; 3:366-375 Sarajevo, Sept. 2003

9. „Classical“ Treatment • Analgesia, sedation, anesthesia, relaxation • Intubation, hyperventilation • Head elevation 30° • Normovolemia, normotension • Osmotherapy accoring to monitored ICP values • Main goal: „normal“ intracranial pressure Marshall LF, Bowers SA; Clin Neurosurg 1982; 29:312-315 Sarajevo, Sept. 2003

10. Treatment in Birmingham, Ala. • Anesthesia, sedation, relaxation • Normoventilation • Supine position, no head elevation • Hypervolemia, vasopressors, inotropes to achieve and maintain CPP > 70 (more often > 90) mmHg • Treatment of raised ICP with osmodiuretics only, all other options are forbidden because of the risk of hypotension • Main goal: normal cerebral perfusion pressure Rosner MJ, et al, J Neurosurg 1995; 83:949-954 Sarajevo, Sept. 2003

11. Treatment in Lund, Sweden • Barbiturate anesthesia, analgesia • Intubation, normoventilation • "relative" hypotension, hypovolemia • Control of MAP with clonidine and ß-blockers; CPP maintained at 50 mmHg • Hyperosmolarity (Na = 150 mmol/l) • Steroids, paracetamol, cooling to 35 °C • Achieve vasoconstriction • Main goal: minimal hydrostatic brain edema Asgeirsson B, et al; Intensive Care Med 1994; 20:260-267 Sarajevo, Sept. 2003

12. Optimal Treatment ? • „Optimal ICP“ ? • „Optimal CPP“ ? • “Optimal O2ER“ ? • „Edema prevention“ ? All centers have documented that their treatment strategy is superior to published results from other centers / groups Sarajevo, Sept. 2003

13. So what? • Every center has its own standards • Most centers see only few patients • Comparison of results between centers are rare Approach Suggested • Creation of an (inter)national database to collect patient data from different centers • Data can be used for quality assurance programs • Introduction of guidelines and clinical pathways Sarajevo, Sept. 2003

14. Available Guidelines • “Guidelines for the Management of Severe Head Injury” (1995), published in major journals, revised in 1997 • Formulated by the “Joint Section on Neurotrauma and Critical Care” of the AANS and CNS • Reviewed & discussed in: • New Horizons Vol. 3, #3, August 1995 • J Trauma, Vol. 42, #5, Supplement May 1997 Sarajevo, Sept. 2003

15. Other Guidelines • European Brain Injury Consortium (EBIC) • Scandinavian Guidelines • Other national guidelines Most guidelines were created using the same process (EBM)and the same published evidence, and therefore came to similar conclusions Sarajevo, Sept. 2003

16. Evidence Based Medicine • Basis for decisions in medicine • „clinical experience“, EBM criteria • What is EBM? • Principle, methods, problems • Why use EBM? • Safety (?), quality, standardisation (?) • How to use EBM? • Individual Search Strategies • Standards & Guidelines, Clinical Pathways Sarajevo, Sept. 2003

17. MY EXPERT OPINION Sarajevo, Sept. 2003

18. Randomized controlled trial Sarajevo, Sept. 2003

19. Practice Parameters Strategies of patient management developed to assist physicians in clinical decision-making.... including standards, guidelines and options Sarajevo, Sept. 2003

20. Practice Standards Based on strong evidence Accepted principles of patient management that reflect a high degree of clinical certainty Sarajevo, Sept. 2003

21. Practice Guidelines Based on weaker evidence Recommendations for patient management that reflect a particular strategy or range of management strategies that themselves reflect a moderate degree of clinical certainty Sarajevo, Sept. 2003

22. Practice Options Based on weakest evidence Other strategies for patient management for which the clinical utility is uncertain (i.e., based on inconclusive or conflicting evidence or opinion) Sarajevo, Sept. 2003

23. Relationship between Evidenceand Guidelines • Guidelines should be related to scientific and clinical evidence • Empirical evidence should take precedence over expert judgment • A thorough review of the literature should precede guideline development • The scientific literature should be evaluated and weighted • Evidence must be ranked and linked to strength of guidelines Sarajevo, Sept. 2003

24. Studies Sarajevo, Sept. 2003

25. Case Report Sarajevo, Sept. 2003

26. Case Series Sarajevo, Sept. 2003

27. Guideline recommendations Guideline recommendations focus on the usual management of the average patient with a specific disorder and are not expected to be applicable to every patient because of the complexity of human biology and the fragmented nature of medical knowledge. Sarajevo, Sept. 2003

28. Purpose Guidelines may serve to reduce practice variation, enhance care continuity, and improve interprovider communication during the care process, especially when decisions are made and services rendered by multiple providers and in different care settings Sarajevo, Sept. 2003

29. Quality of a Guideline The quality of a guideline is measured in terms of clarity, clinical applicability, flexibility, reliability and reproducibility both for the individual guideline recommendations and for their coherent integration into a functional form Sarajevo, Sept. 2003

30. Quality of Guidelines Attributes of guidelines quality are assessed objectively by quantitating their impact on measured outcomes of care. Sarajevo, Sept. 2003

31. AUSTRIA, VARIATION INTREATING TBIICP MONITORING Sarajevo, Sept. 2003

32. Brain Pressure Monitoring and Outcome in Britain (Murray, Teasdale, et.al., 1999) Sarajevo, Sept. 2003

33. University of Luisville, Kentucky, 2001 Sarajevo, Sept. 2003

34. ICP and OUTCOME Austria ICP > 25 for less then 3 hours increases chances of good outcome 10 times; chances of death 25 times if increased for more then 3 hours consecutively Sarajevo, Sept. 2003

35. SYSTOLIC BLOOD PRESSURE < 90 mmHg and DEATH Nove Zamky SBP less then 90 mmHg for more then 3 hours significantly increases chances of death Sarajevo, Sept. 2003

36. Research Guideline Implementation CQI: Cont.Quality Improvement • Analysis of outcomes and treatment strategies • Comparison to other dpts (pooled data, or „best Dpt“ data) • Development of strategies to improve performance (together with IGEH) • Implementation of improvement strategies • Re-evaluation..................... Sarajevo, Sept. 2003

37. Vision • Guidelines define goals but (usually) DO NOT explain how to reach these goals • One of the most important steps in our project will be to develop, implement and test „clinical pathways“ • Clinical pathways should explain how to reach the goals defined by the guidelines Sarajevo, Sept. 2003

38. Int. Neurotrauma Research Org. is a collaborative non-profit, non-governmental organization (NGO) based in Vienna, with it activities directed internationally Sarajevo, Sept. 2003

39. MISSION Improve the recovery of patients who suffer a brain or spinal cord injury through helping hospitals implement evidence-based medical care, assisting in the reengineering of their trauma systems to better treat neurotrauma patients and collaborating on clinical research to continuously improve the scientific foundations of evidence-based guidelines and protocols. Sarajevo, Sept. 2003

40. FELLOWSHIPS IGEH / INRO hosts fellows from Europe and helps applicants in identification of grants and support application development Sarajevo, Sept. 2003

41. THANK YOU I LOOK FORWARD TO WORK WITH YOU ON THIS FASCINATING PROJECT Sarajevo, Sept. 2003