QUESTION RELATED TO PROGNOSIS IN THE

PRACTICE OF MEDICINE:
2
What are the
consequences
of having the
disease?
3
Biologic
onset
Clinical
Diagnosis
Outcome
Recovery
Disability
Death
etc
Natural history of diseases
Clinical courses
(no medical intervention)
(medical intervention)
QUESTIONS ABOUT HOW PATIENTS ILLNESS
WILL AFFECT THEM:
4
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?
DESCRIBING OUTCOMES OF DISEASE:
5
Should include the full range of manifestations that
would be considered important to patients (5Ds):
Death
Disease
Disability
Discomfort
Dissatisfaction
6
Onset of acute
myocardial infarction
1. Age >>
2. Male
3. LDL>/ HDL<
4. Cigarette smoking
5. Hypertension
6. Inactivity
1. Age >>
2. Male
3. Anterior infarction
4. Hypotension
5. Congestive heart failure
6. Ventricular arrythmia
PROGNOSIS
RISK
Outcome:
Death, reinfarction Well
Differences between risk and prognostic factors for acute
myocardial infarction
RATES COMMONLY USED TO DESCRIBE
PROGNOSIS:
Rate Definition*
5-year survival Percent of patients surviving 5 years from some point in the course of their disease
Case fatality Percent of patients with a disease who die of it
Disease-specific mortality Number of people per 10,000 (or 100,000) population dying of a specific disease
Response Percent of patients showing some evidence of improvement following an intervention
Remission Percent of patients entering a phase in which disease is no longer detectable
Recurrence Percent of patients who have return of disease after a disease-free interval
7
*Time under observation is either stated or assumed to be sufficiently long so that all events that will occur
have been observed
Critical Appraisal : Prognosis
1. Are the results of the study valid?
2. Are the results of this study important?
3. Can I apply this valid, important
evidence about prognosis to my patient?
8
a) Was a defined, representative sample of patients
assembled at a common (usually early) point in the course
of their disease?

b) Was the follow-up of the study patients sufficiently long
and complete?

c) Were objective outcome criteria applied in a blind
fashion?

d) If subgroups with different prognoses are identified, was
there adjustment for important prognostic factors and
validation in an independent test set patients?
1. Are the results of the study valid?
9
10
1.(a) Was a defined, representative sample of
patients assembled at a common (usually early)
point in the course of their disease?
It is preferable if study patients are enrolled at a
uniformly early time in the disease, usually when the
disease first becomes manifest.
Patients should also be representative of the underlying
population
The Methods section should describe the stage at which
patients entered the study
11
1.(b) Was follow-up sufficiently long and complete?
Length of follow-up should be long enough to detect the
outcome of interest (e.g., for pregnancy outcomes, nine
months; for cancer, many years).

All patients should be followed from the beginning of the
study until the outcome of interest or death occurs

Reasons for non follow-up should be provided (e.g., death,
change address, etc)

Most evidence-based journals require at least 80% follow-up
for a prognosis study to be considered valid.
The Results section should state the median or mean length of
follow-up.
12
1.(c) Were objective outcome criteria applied in a
blind fashion?
A clear definition of all outcomes should be provided

Investigators making judgments about clinical outcomes
are kept blind to subjects clinical characteristics and
prognostic factors. Minimize bias.

The Methods section should provide a clear definition or
explicit criteria for each outcome, and whether
determination is blinded to prognostic factors will be
found in either the Methods or Results sections.
13
1.(d) If subgroups with different prognoses are
identified, was there adjustment for important
prognostic factors and validation in an
independent test set patients?
Prognostic factors:
conditions that, when present in persons already known to
have disease, are associated with an outcome of the disease
Risk factors:
condition that can be identified in well persons and, when
present, are associated with an increased risk of acquiring
disease
The Results section should identify any prognostic factors and
whether or not these have been adjusted for in the analysis.
a) How likely are the outcomes over time?
b) How precise is this prognostic estimate?
2. Are the results of this study important?
14
15
2.(a) How likely are the outcomes over time?
% of outcome of interest at a particular point in time (1 or 5
year survival rates),

Median time to the outcome (e.g. the length of follow-up by
which 50% of patients have died)

Event curves (e.g. survival curves) that illustrate, at each point
in time, the proportion of the original study sample who have
not yet had a specified outcome.
..:: 5 years curve for three different diseases ::..
17
2.(b) How precise is this prognostic estimate?
Precision 95% confidence interval (CI)
The narrower the confidence interval, the more precise is the
estimate.

Precision of the estimates depends on number of observations
on which the estimate is based shorter follow-up periods
results in more precision.
a) Is my patient so different from those in the study that its
results cannot apply?

b) Will this evidence make a clinically important impact on my
conclusions about what to offer or tell my patient?
3. Can I apply this valid, important evidence
about prognosis to my patient?
18
19
3.(a) Is our patient so different from those in
the study that its results cannot apply?
How well do the study results generalize to the patients in
your practice?
Compare patients' important clinical characteristics,
Read the definitions thoroughly
The closer the match between the patient before you and those in
the study, the more confident you can be in applying the study
results to that patient.

For most differences, the answer to this question is no, we
can use the study results to inform our prognostic conclusions.
20
3.(b) Will this evidence make a clinically
important impact on our conclusions about
what to offer or tell our patient?
Initiating or not therapy,
Monitoring therapy that has been initiated,
Deciding which diagnostic tests to order.
Providing patients and families with the information they want
about what the future is likely to hold for them and their illness.
Communicating to patients their likely fate
Guiding treatment decisions
Comparing outcomes to make inferences about quality of care
21