Yuki Yunanda

Natural history of diseases (no medical intervention)

Recovery
Clinical Disability
Biologic Outcome
onset Diagnosis Death
etc

Clinical courses
(medical intervention)
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Critical Appraisal : Prognosis

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1. Are the results of the study valid?

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?
See “Introduction”
Pg. 2 col. 2
6
See Methods
Pg.2 Col. 2 Pr. 1
8
See “Methods”
Pg. 2 Col. 2 Pr. 5 & 6
10
• To minimize the effects of bias in measuring the outcome,
investigators should established specific criteria to define
each important outcome and then used them throughout
patient follow-up.*
• In valid studies, investigators making judgments about
clinical outcomes are kept “blind” to these patients clinical
characteristics & prognostic factors.*

*(Straus, SE, Richardson, SE, Glasziou, P, Haynes, RB. Evidenced-Based

Medicine: How to Practice and Teach EBM)
• In administrative databases, those who record outcome
data will always be unblinded, (and those who record
predictor data, always blinded) but will be unaware of the
hypotheses of future investigators making use of
database.**

• One relatively easy safeguard that you can use is to leave

data collection personel unaware of study hypotheses.**

• **(Guyatt, G. Determining Prognosis and Creating Clinical Rule

Decision in Clinical Epidemiology: How to Do Clinical Practice
Research, 3rd edition, 2006. p338-339).
“Were objective & unbiased outcome criteria used?”
• Investigators should clearly specify and define their target
outcome before the study and, whenever possible, they
should base their criteria on objective measure.***

• As the subjectivity of the outcome definition increases, it

becomes more important that individuals determining the
outcomes are blinded to the presence of prognostic
factors.***

***(Randolph, A, Bucher, H, Richardson, WS, Wells, G, Tugwell, P, Guyatt, G.

Prognosis in JAMA User’s Guide)
See “Methods”
Pg. 2 Col. 2 Pr. 5
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See “Table 1” Pg. 5
See “Methods”
Pg. 3 Col.1 Pr. 3 & 4
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2. Are the results of this study important?

a) How likely are the outcomes over time?

b) How precise is this prognostic estimate?
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2.(a) How likely are the outcome over time?

• % of outcome of interest at a particular point in

time (1, 5, 10 etc. survival rates,
• Mean, Median time (length of the follow-up by
which 50% of patients have died) of the outcome
• Event curves
• Effect size (Hazard ratio, Rate ratio, Odds ratio,
etc.)
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2. Are the results of this study important?
2. Are the results of this study important?
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3. Can I apply this valid, important evidence

about prognosis to my patient?
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?
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Glasser, SP, Cutter,G. Association, Cause and Correlation in Essential
Clinical Research. Springer. 2008.
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