Sarajevo, Sept. 2003 1 Evidence based medicine and neurotrauma (Medicina bazirna na činjenicama i neurotrauma) Univ.Doc. Dr.Med. Martin Rusnak, CSc Int

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/


Hippocrates

“There are, in effect, two things, to know and to

believe one knows; to know is science; to

believe one knows is ignorance.”


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


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.


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 )


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


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


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


„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


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


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


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


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


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


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


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


MYEXPERTOPINION


Randomizedcontrolled

trial


Practice Parameters

Strategies of patient management developed

to assist physicians in clinical decision-

making.... including standards, guidelines

and options


Practice Standards

Based on strong evidence

Accepted principles of patient management that reflect a high degree of clinical certainty


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


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)


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


Studies

RCT

Randomized ControlledTrial

CS

Cohort Study

CCS

Case Control Study


Case Report

Case Report

CS


Case Series

Case Series

CS


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.


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


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


Quality of Guidelines

Attributes of guidelines quality are assessed objectively by quantitating their impact on measured outcomes of care.


AUSTRIA, VARIATION IN TREATING TBIICP MONITORING

No. of Departments

% of ICP monitoring

11

14

13

0-24

25-69

70-100


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%


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 %


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


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


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


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


Int. Neurotrauma Research Org.

is a collaborative non-profit, non-governmental

organization (NGO) based in Vienna, with it

activities directed internationally


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.


FELLOWSHIPS

IGEH / INRO hosts fellows from Europe and

helps applicants in identification of grants and

support application development


THANK YOU

I LOOK FORWARD TO WORK WITH YOU ON THIS FASCINATING

PROJECT

Documents

Sarajevo, Sept. 2003 1 Evidence based medicine and neurotrauma (Medicina bazirna na činjenicama i neurotrauma) Univ.Doc. Dr.Med. Martin Rusnak, CSc Int