Do we need evidence based

medicine?

Eminence

based medicine

www.european-real-bestpractice.org

Evidence Based Medicine

Decision making on (medical) actions,
intentionally based on a transparant and
systematic analysis of available
evidence, and this applied to a real-life
clinical context

Evidence Based Medicine

Decision making on (medical) actions,
intentionally based on a transparant and
systematic analysis of available
evidence, and this applied to a real-life
clinical context
With the goal to decrease the
discrepancy between medical actions
And
Medical knowledge

Evidence Based Medicine

1. Individual level
a) Individual patient individual physician
b) Individual physician and his patients with a
specific problem

(systematic review)
2. Organisational (Hospital) level
a) Group of physicians and their patients with a
specific problem
(Protocolized medicine, standing orders)
b) Different groups of physicians and a patient
with one problem on the borderline of
different specialties
With different comorbidities

Evidence Based Medicine

1. Individual level
a) Individual patient individual physician
b) Individual physician and his patients with a
specific problem

(systematic review)
2. Organisational (Hospital) level
a) Group of physicians and their patients with a
specific problem
(Protocolized medicine, standing orders)
b) Different groups of physicians and a patient
with one problem on the borderline of
different specialties
With different comorbidities

3. Society level

RRT at ICU: a cost utility analysis

Laukkanen et al, Intensive Care Medicine, 2012

Evidence Based Medicine

Dogmatic
Cook book recipes (remember to stay
critical)
One size fits all (there is many ways to
prepare pasta al ragu or cheese cake)
accountability or performance index

toolbox (to the contrary!)

What is evidence?

What is evidence?

Types of questions

1.
2.
3.
4.

Intervention studies
Diagnostic questions
Prognostic questions
Aetiology

What is evidence?

In the perfect world, all evidence comes

from perfectly designed, large randomised
trials

Randomised Controlled Trial (RCT)

An experimental comparison study in which

participants are allocated to
treatment/intervention or control/placebo groups
using a random mechanism (see randomisation).
Best to study the effect of an intervention.

Advantages:
unbiased distribution of confounders
blinding more likely
randomisation facilitates statistical analysis.

What is evidence?
In the real world:
no RCT available for every question
not affordable: RCTs are expensive
(resulting in one of the most painful catch 22s of EBM)

not feasible (for ethical, logistical

reasons)
not possible ( orphan diseases)

What is evidence?
In the real world:
no RCT available for every question
not affordable: RCTs are expensive
(resulting in one of the most painful catch 22s of EBM)

not feasible (for ethical, logistical

reasons)
not possible ( orphan diseases)
Internal validity of RCTs is often
questionable
bias assessment

What is evidence?
In the real world:
no RCT available for every question
not affordable: RCTs are expensive
(resulting in one of the most painful catch 22s of EBM)

not feasible (for ethical, logistical

reasons)
not possible ( orphan diseases)
Internal validity of RCTs is often
questionable
bias assessment
External validity of RCTs is frequently
problematic

What about indirect

evidence?

Cohort Study
Data are obtained from groups who have been exposed,
or not exposed, to the new technology or factor of
interest (eg. from databases).
No allocation of exposure is made by the researcher.
Best for study the effect of predictive risk factors on an
outcome. (eg diabetes or not and CV outcomes)
Advantages:

ethically safe; can be used to assess rare exposures & multiple outcomes
subjects can be matched;
can establish timing and directionality of events;
eligibility criteria and outcome assessments can be standardised;
administratively easier and cheaper than RCT.
Disadvantages:

controls may be difficult to identify;

exposure may be linked to a hidden confounder;
blinding is difficult; randomisation not present;
for some diseases, large sample sizes or long follow-up necessary to obtain
sufficient events.

Case-Control Studies
Patients with a certain outcome or disease and an

appropriate group of controls without the outcome or

disease are selected (usually with careful consideration of
appropriate choice of controls, matching, etc) and then
information is obtained on whether the subjects have been
exposed to the factor under investigation. (2*2 tables)
Advantages:
quick and cheap;
only feasible method for very rare disorders or those with
long lag between exposure and outcome;
fewer subjects needed than cross-sectional studies.
Disadvantages:
reliance on recall or records to determine exposure status;
Non establsihed or corrected for confounders;
selection of control groups is difficult;
potential bias: recall, selection bias, lead time bias.

Cross-Sectional Survey
A study that examines the relationship between diseases (or other
health-related characteristics) and other variables of interest as they
exist in a defined population at one particular time (ie exposure and
outcomes are both measured at the same time).
Best for quantifying the prevalence of a disease or risk factor, and for
quantifying the accuracy of a diagnostic test.

Advantages:
cheap and simple;
ethically safe.
Disadvantages:
establishes association at most, not causality;
recall bias susceptibility;
confounders may be unequally distributed;
Neyman bias (= incidence/prevalence bias; factor influences
mortality of the condition, eg smokers assessed after AMI)
group sizes may be unequal.

What is evidence : systematic

Objective scientific reasons (because science is not always scientific)

too much information

Incomplete

Biased
Prejudiced
Problem of generalisibility

Impact of evidence based medicine

%

Q1: change to newer treatment if shown to be superior

Q2: change to older treatment if shown to be equally effective
but less expensive than newer

Evidence Based Medicine: GRADE