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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/. Hippocrates. - PowerPoint PPT Presentation
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Sarajevo, Sept. 20031
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. 20032
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. 20033
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. 20034
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. 20035
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. 20036
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
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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. 20038
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
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„Classical“ Treatment
Analgesia, sedation, anesthesia, relaxation Intubation, hyperventilation Head elevation 30° Normovolemia, normotension Osmotherapy accoring to monitored ICP
values Main goal: „normal“ intracranial pressureMarshall LF, Bowers SA; Clin Neurosurg 1982; 29:312-315
Sarajevo, Sept. 200310
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 pressureRosner MJ, et al, J Neurosurg 1995; 83:949-954
Sarajevo, Sept. 200311
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 edemaAsgeirsson B, et al; Intensive Care Med 1994; 20:260-267
Sarajevo, Sept. 200312
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. 200313
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. 200314
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. 200315
Other Guidelines
European Brain Injury Consortium (EBIC) Scandinavian Guidelines Other national guidelinesMost guidelines were created using the same
process (EBM)and the same published evidence, and therefore came to similar conclusions
Sarajevo, Sept. 200316
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. 200317
MYEXPERTOPINION
Sarajevo, Sept. 200318
Randomizedcontrolled
trial
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Practice Parameters
Strategies of patient management developed
to assist physicians in clinical decision-
making.... including standards, guidelines
and options
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Practice Standards
Based on strong evidence
Accepted principles of patient management that reflect a high degree of clinical certainty
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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
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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)
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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
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Studies
RCT
Randomized ControlledTrial
CS
Cohort Study
CCS
Case Control Study
Sarajevo, Sept. 200325
Case Report
Case Report
CS
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Case Series
Case Series
CS
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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. 200328
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. 200329
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. 200330
Quality of Guidelines
Attributes of guidelines quality are assessed objectively by quantitating their impact on measured outcomes of care.
Sarajevo, Sept. 200331
AUSTRIA, VARIATION IN TREATING TBIICP MONITORING
No. of Departments
% of ICP monitoring
11 14 13
0-24 25-69 70-100
Sarajevo, Sept. 200332
Brain Pressure Monitoring and Outcome in Britain (Murray, Teasdale, et.al., 1999)
Hospitals: Glasgow (N=384)
Edinburgh (N=262)
Liverpool (N=214)
Southampton (N=128)
% monitored 29% 55% 0% 38%
% Good recovery or Moderate disability
45% 46% 32% 41%
% Severe disability 17% 10% 20% 23%
% Dead/ vegetative 38% 44% 45% 34%
Sarajevo, Sept. 200333
University of Luisville, Kentucky, 2001
Pre-TBI Guidelines
Post-TBI Guidelines
% Change
Intensive Care Days 21.2 16.8 Reduction
22 % Ventilator Days 14.4 11.5 Reduction
24 % Rehabilitation Service Days 31 22.5 Reduction
27 % Overall in Hospital Cost per Survivors
Reduction 20 %
Sarajevo, Sept. 200334
ICP and OUTCOME Austria
ICP>25 mmHg Test value
P(α=0.025) OR CI at 95% OR
<3 hours 0.05 10 1,112 89,949 >= 3 hours 0.001 0.146 0,044 0,482 Improved No n.s. 2.98 0,892 9,935 <3 hours n.s. 0.5 0,055 4,585 >= 3 hours n.s. 0.79 0,227 2,777
Not Improved
No n.s. 1.76 0,474 6,544 <3 hours 0.05 0 0 >= 3 hours 0.0001 24.93 2,989 208,003 Died No 0.01 0.09 0,010 0,720
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. 200335
SYSTOLIC BLOOD PRESSURE < 90 mmHg and DEATH Nove Zamky
P CI 95% OR Day of Follow-up Hours χ2 (α=0.025) OR Upper Lower
10 >3 0.000 ≤0.0001 22.065 6.395 76.13 30 >3 0.000 ≤0.0001 47.017 6.248 353.814 90 2-3 0.000 ≤0.0001 8.070 2.327 27.99
180 >3 0.000 ≤0.0001 31.873 4.235 239.884
SBP less then 90 mmHg for more then 3 hours significantly increases chances of death
Sarajevo, Sept. 200336
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..................... Implementation
Guideline
Research
Sarajevo, Sept. 200337
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. 200338
Int. Neurotrauma Research Org.
is a collaborative non-profit, non-governmental
organization (NGO) based in Vienna, with it
activities directed internationally
Sarajevo, Sept. 200339
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. 200340
FELLOWSHIPS
IGEH / INRO hosts fellows from Europe and
helps applicants in identification of grants and
support application development
Sarajevo, Sept. 200341
THANK YOU
I LOOK FORWARD TO WORK WITH YOU ON THIS FASCINATING
PROJECT
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