EBM Prognosis (DR - Osman)

Evidence-based Medicine
PROGNOSIS
1
Prognosis
• A prediction of the future course of disease

following its onset
• Refers to the possible outcomes of a disease and
the frequency with which they can be expected to
occurs (eg death in a patient with dementia)
• Sometimes the characteristics of a particular
patient can be used to more accurately predict that
patient.s eventual outcome (eg a patient with
dementia behavioral problem may have worse
prognosis)
2
Prognostic Factors
• Demographic data (eg age)
• Disease specific (eg tumor stage)
• Comorbid (other conditions accompanying the
disease in question)
• Can predict any outcome
• Need not necessarily cause the outcomes, just be
associated with them strong enough to predict
development
• Risk factor?
3
Study Design
• The best design is cohort study
• Follow one or more groups (cohorts) of
individual who have not yet suffered an adverse
event and monitor the number of outcome
events over time.
• An ideal cohort study consists of a well defined
sample of individuals representative of the
population of interest and uses objective
outcome criteria
4
Study Design Laboratory
Eksperimental Animal
Intervention Human
Descriptive
No group comparison
Natural exposure
Observational
Group comparison Cross-sectional
Cohort
Analytic 5
Case control
Study design according to time
E Prospective O
Cohort
Retrospective O
E Natural
Case-control E Experimental O
Intervention
Past Present Future

6
Questions About How Patients’
Illness Will Affect Them
• Is it dangerous?
• Could I die of it?
• Will there be pain?
• How long will I be
able to continue my
present activities?
• Will it ever go away
altogether?
7
These Questions Share Three
Elements
• A qualitative aspect
– Which outcomes could happen?
• A quantitative aspect
– How likely are they to happen?
• A temporal aspect
– Over what time period?
8
Describing Outcomes of Disease
• Should include the full range of

manifestations that would be considered
important to patients:
– Death
– Disability
– Discomfort
– Dissatisfaction
9
Objectives
• To present a framework for appraising the

validity, importance and applicability of
evidence about prognosis, using the same sorts
of guides as we used on diagnosis and therapy
• When scanning articles about prognosis, the
first two validity guides for screening can be
used for selecting only those that pass both
guides to spend more time on
10
Was a defined, representative
sample of patients assembled
at a common (usually early)
point in the course of their
disease?
Primary guide
11
2 related issues
• How well defined the individuals in the
study are, and whether they are
representative of the underlying population?
• Whether the study patient are all at similar,
well-defined point in the course of their
disease?
12
13
“Inception Cohort”
• We look to see that study patients were included at
a uniformly early time in the disease, ideally when
it first becomes clinically manifest
• An exception occurs when we want only to learn
about the prognosis of a late stage in the disease;
in this case we’d look for a representative and
well-defined sample of patients who were all at a
similarly advanced stage
14
Was patient follow-up sufficiently
long and complete?
Primary guide
15
Follow-up
• “5 and 20” rule: fewer than 5% loss probably leads to
little bias, greater than 20% loss seriously threatens
validity, and in-between amounts cause intermediate
amounts of trouble
• The greater the number of patients loss to follow-up,
the less accurate the estimate regarding the risk of the
of the adverse outcome
• The larger the number of patients whose fate is
unknown relative to the number who have suffered an
event, the greater the threat to the study’s validity
16
Follow-up
• If the number of patients lost patentially
jeopardizes the study’s validity, look for the
reasons for patients being lost, and compare the
important demographic and clinical
characteristic of patient who were lost to the
patients in whom follow-up was complete
• If investigator omit information abaout reason
and characteristics of the patient who are lost,
the strength of inference from study result will
be weaker 17
Were objective outcome criteria
applied in a ‘blind’ fashion?
Secondary guide
18
Measuring Outcomes
• Specific criteria that define each important
outcome and then used them throughout
patient follow-up
• Investigators making judgments about
clinical outcomes are kept “blind” to
patients’ clinical characteristics and
prognostic factors
19
Was there adjusment for
important prognostic factors?
Secondary guide
• When comparing the prognosis of 2 group of

patient, investogator should consider whether
their clinical characteristics are similar, and
adjust the analysis for any differences they find
20
Was there adjusment for important prognostic
factors?
Secondary guide
• Framingham study: rate of stroke in patient with

atrial fibrilation and rheumatic heart disease 41
per 1000 person-years, similar to the rate for
patients with atrial fibrilation but no rheumatic
heart disease
• Once adjusment were made for the age, gender
and hypertensive status, the result show rate of
stroke was 6 fold greater in patient with
rheumatic heart disease and atrial fibrilation
21
factors?
Secondary guide
• Many studies of prognosis break study group into

cohort based on suspected prognostic factor
• Eg Pincus et al followed a cohort of patient with
rheumatic arthritis for 15 yrs. They separated the
patient based on demographic characteristic,
disease variable, and functional status. Result:
some demographic variable, functional status
were strongly predictive of mortality
22
factors?
Secondary guide
• Treatments can also alter patient outcomes, they sholud

be taken into account when analyzing prognostic
factors.
• Eg In a study from Framingham examined the prognosis
of Q-wave versus non Q-wave first myocardial
infarction, the investigator adjusted for age, sex, present
hypertention, angina pectoris, congestive heart failure,
and cardiovascular disease prior to the infarct but not
adjusted for beta-blocker
23
Subgroups With Different
Prognoses
• Adjustment for other important prognostic

factors
– Stratified analyses
– Multiple regression analyses
24
The Statistics of Determining Subgroup
Prognoses Are All About Prediction, Not
Explanation
• Prognostic factor:
– Physiologically logical
– A biologically nonsensical and random, non-
causal quirk in the data (e.g., whether the
patient lives on the north or the south side of
the street)
25
The first time a prognostic factor is
identified, there is no guarantee that it
really does predict subgroups of patients
with different prognoses
• The initial patient group in which prognostic

factors are found is called a “training set” or
“derivation set”
• We should look to see whether the predictive
power of such factors has been confirmed in
subsequent, independent groups of patients,
termed “test sets” or “validation sets”
26
How likely are the outcomes over
time?
27
How Likely Are the Outcomes
Over Time?
• Typically they are reported in three ways:
– As a percentage of survival at a particular point
in time (such as 1-year or 5-year survival rates)
– As median survival (the length of follow-up by
which 50% of study patients have died)
– As survival curves that depict, at each point in
time, the proportion (expressed as a percentage)
of the original study sample who have NOT yet
had a specified outcome
28
29
How precise are the prognostic
estimates?
95% Confidence Interval
30
Are the study patients similar to
our own?
– Demographic and clinical characteristics

– Are the study patients so different from ours
that we should not use the results at all in
making predictions for our patients?
31
Will this evidence make a clinically important
impact on our conclusions about what to
offer or tell our patient?
– A treat/don’t treat decision

– Valid evidence can be useful in providing
patients and families with the information
they want about what the future is likely to
hold for them and their illness
32
Thank You
33

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Evidence-based Medicine

• A prediction of the future course of disease

Past Present Future

• Should include the full range of

• To present a framework for appraising the

• When comparing the prognosis of 2 group of

• Framingham study: rate of stroke in patient with

• Many studies of prognosis break study group into

• Treatments can also alter patient outcomes, they sholud

• Adjustment for other important prognostic

• The initial patient group in which prognostic

– Demographic and clinical characteristics

– A treat/don’t treat decision

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