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The central role of the Medical Laboratory
in a World of Managed Health
An EDMA presentation of the benefits of in vitro testing as
a basis for better decisions in health care
Jan 2002
EDMA
In Vitro Testing:
Health Information Technology
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Medical Laboratory testing is highly automated and provides
increasing quantities of valuable data at low cost.
The information about health that this data provides is a basis for better
decision-making in health care
 by medical professions in management of trauma and disease
 by individuals for evaluation and maintenance of their own health
 by health economists to assess the value of medical interventions
However, medical professions are often poorly informed about
advances in in vitro testing and opportunities to improve health are lost
The public is becoming aware of health care interventions and the
value of in vitro testing, via media stories and increasingly via the
Internet
This will inevitably lead to changes in the way health care is delivered
For better decisions in health care
Jan 2002
EDMA
Why do we need health care?
Risk and Responsibility for Health
Risk by Chance
Genetics, trauma
Collective responsibility
Insurable collectively
Risk by Choice
Diet, lifestyle
Individual responsibility
Still insurable collectively
Disease Management
“Patients”
Medical responsibility
Collective
Health Management
“People”
Personal responsibility
Individual
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Jan 2002
Choices imply responsibility as well as freedom
Individual choices can greatly increase risk of disease
Better individual choices lead to better health
Better individual health management now
will reduce the need for medical intervention later
EDMA
Screening and Prevention
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Screening targeted populations for disease risk
Providing information about predisposition to disease / genetic
testing
Preventing spread of infection, e.g. via the blood supply
Ensuring continued health and avoiding disease as part of
individual responsibility for health
In vitro testing : an investment in health care
Jan 2002
EDMA
Diagnosis,
the key to effective treatment
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Early and correct diagnosis is the key to effective treatment
 Late diagnosis : possibly ineffective treatment of advanced disease
 Incorrect diagnosis : incorrect treatment
Family Practitioner is the diagnostic gatekeeper for treatment
 not aware of the wide range of very sensitive & specific tests
 not able to use the results to full advantage
Patients / public beginning to learn from Internet
 Patients are interested in early and correct diagnosis
 The “impatient” patient
Normal results eliminate doubt, rule out unnecessary interventions,
provide reassurance
Early and correct diagnosis ensures that subsequent
treatment is appropriate and effective
Jan 2002
EDMA
Therapy & Rehabilitation
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Evaluating patient’s condition during treatment
Reassessment and update of treatment
Monitoring and managing treatment (theranostics), for example
 self-testing in diabetes
 determining susceptibility to antibiotics
 therapeutic drug monitoring in immunosuppression
Objective information for Evidence Based Medicine
Genomic pharmaceuticals (drugs tailored for the individual)
Rehabilitation and wellness testing
Laboratory testing provides objective information in
evaluating the effects of treatment and a return to health
Jan 2002
EDMA
In Vitro Testing:
An enabling technology
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Jan 2002
Advanced technologies
 antibody-based immunoassays, fluorescent markers
 nucleic acid probes, genetics
 surface nano-techniques (diagnostic chips)
In vitro testing is an enabling technology
 allows self testing and individual responsibility for health
 can provide genetic data about disease risk factors
 is the basis of genomic drug therapy, pharmaceuticals tailored to
the individual and patient selection for drug therapy.
 provides objective information for evidence based medicine
Reimbursement systems must become adaptable and flexible to
support health management and the adoption of this enabling
technology
EDMA
In Vitro Testing: Providing evidence for
medical interventions
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Evidence Based Medicine
 Resource allocation in health care increasingly requires evidence
of effectiveness / benefit
 Increased use of laboratory testing will provide the objective
evidence that is needed to assess medical treatments
Evidence based in vitro testing
 In vitro test results provide information as a basis for better
medical decision making. Most tests provide incremental
information in a wide variety of clinical situations: difficult to
measure the value of a single test result in a given clinical
situation. Section B includes examples of benefits of in vitro
testing
In vitro testing : for better decisions in health care
Jan 2002
EDMA
In Vitro Testing:
Cost-effective to test more
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Jan 2002
In vitro tests < 1% of total health care costs
 increased testing cannot significantly increase costs of health care
 increased testing will allow earlier and more correct treatment,
decreasing the costs of health care long term
Personnel costs are the dominant expense in health care
 consultation time : expensive for doctor and patient
 automated laboratories : cost / test decreased 50 % in 10 years
A possible future for in vitro testing
 self ordering of tests - individual awareness
 multi-parameter tests done on small sample (diagnostic chip)
 results available and commented on by “Internet Consultant”
 individual consults with peers and family
 first visit to family physician if needed
Reimbursement systems out of phase with possible developments
EDMA
In Vitro Testing: Benefits
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EDMA approach
 Does the treatment or intervention benefit the patient?
 Does it have a clinical benefit?
 If so, is it affordable and who should pay for it?
To view EDMA’s presentation on the benefits of in vitro testing,
including examples click here
In vitro testing provides:
 patient benefits
 clinical benefits and
 economic benefits
The basis for better decisions in health care
Jan 2002
EDMA
Contribution to
Individual/Patient satisfaction
Positive effect of normal results
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for individuals - confirming health
for doctors - removing doubts
Meeting consumer expectations
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Jan 2002
Providing information
Enabling self treatment
Preventing infections
Avoiding unnecessary, painful or invasive treatment
Avoiding relapses, delaying complications
Getting better faster
Reducing hospital stay, reducing family disruption
In vitro testing provides objective information
when assessing treatment
EDMA
Clinical contribution
Objective information
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Valid, quantified information in a simple format
Vital component in evaluation of treatment
As a basis for better decisions
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Definitive diagnosis / appropriate treatment
Reduction of morbidity
Risk prediction and reduction
Improved compliance
Monitors / quantifies therapy
Scientific basis for therapy and rehabilitation
The medical laboratory is an indispensable part
of the practice of medicine
Jan 2002
EDMA
Economic contribution
Avoiding unnecessary treatment
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Accurate diagnosis
Helps to rule out expensive treatments
Allows procedures and drugs to be targeted
Reduces long term drug treatment
Improves compliance
Reduces costs of treatment of complications
Shortening length of hospital stay
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Faster diagnosis
Makes therapy more effective
Containment of disease, lowers risk of infection
Investment in in vitro testing provides economic benefits,
reducing overall healthcare expenditure
Jan 2002
EDMA
Establishing the value
of laboratory
medicine
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Medium to long term benefits of laboratory testing
 screening to prevent infection and provide information about risk
of disease
 early & correct diagnosis ensuring subsequent treatment is
relevant and cost-effective
 monitoring recovery from trauma and effects of treatment, that
allow for reassessment and updating of therapy
 objective information supporting Evidence Based Medicine
 targeting drug treatments according to patient response
In vitro testing is the basis for
better decisions in health care
Jan 2002
EDMA