PROGNOSTIC STUDY
Sitti Wahyuni
Evidence Based Medicine
Some slides are modified from
Nia Kurniati, Robert Sinto’s
Center for Clinical Epidemiology and Evidence-Based Medicine (CEEBM)
Faculty of Medicine, University of Indonesia – Cipto Mangunkusumo Hospital
Introduction
• Prognosis: the prediction of the future course of
events following the onset of thedisease.
• Can include death, complications,
remission/recurrence, morbidity, disability and
social or occupational function.
• Patient’s, doctor’s, and insurance concern
• Possible outcomes of disease and the frequency
with which they can be expected to occur.
• Natural history: the evolution of disease without
medical intervention.
• Clinical course: the evolution of thedisease in response
to medical intervention.
Risk factors vs Prognostic factor
• Risk factor
• Include lifestyle behaviors and environmental exposures that are associated with the
development of a target disorder.
• Example: smoking is an important risk factor for developing lung cancer, but tumor
stage is the most important prognostic factor in individuals who have lung cancer.
• Prognostic factors
• Factors associated with a particular outcome among disease subjects. Can predict a
good or bad outcome
• Need not necessarily cause the outcome, just be associated with them strongly enough
to predict their development
• Examples include age, co-morbidities, tumor size, the severity of disease, etc.
Prognosis Suffer target
outcome
Patients at risk Prognostic
Risk factors of target event Time
factor
Do not suffer
target outcome
Types of reports onprognosis
• Best evidence: a systematic review of prognosis studies
• Most available: Cohort studies
• Investigators follow individuals with disease over time and monitor for the
occurrence of the outcome
• Other sources:
• Case-control studies
• Control group of RCTs
Critical Appraisal of Prognostic Study
Validity Assessing risk ofbias
Magnitude of resultand
Importance its precision
External validity /
Applicability generalizability
Biasin Epidemiology Study: GATEApproach
The PECOT RAMBOMAN
P Recruitment bias
Population/ Recruitment
Participants
Allocation Allocation Bias
Exposure and Maintenance Maintenance Bias
Comparison E C
Blind
Outcomes Objective Measurement Bias
yes O Measurements
Time no
T ANalyses Confounding Bias
Bias in A Study ofPrognosis
Selection/ Allocation Maintained
Recruitment Bias Bias Bias
Appropriate-
ness of Appropriate
participants’ definition of Long and
prognostic complete
selection
factors follow-up
Measurement/ Confounding
Observation Bias
Bias
Multivariate
Blinding and and/or
objective subgroup
measurement analyses
A. VALIDITY
1. Was a defined, representative sample of patients assembled at a common (usually
early) point in the course of their disease?
2. Was the follow-up of the study patients sufficiently long andcomplete?
3. Were objective outcome criteria applied in a blind fashion?
4. If subgroups with different prognoses are identified, was there anadjustment for
important prognostic factors and validation in an independent “test set” patients?
B. IMPORTANCE
• How likely are the outcomes over time?
• % of the 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)
• How precise is this prognostic estimate?
• Precision: 95% confidenceinterval
• The narrower the confidence interval, the more precise the estimate.
SurvivalRate
C. APPLICABILITY
1. Is our patient so different from those in the study that its results
cannot apply?
2. Will this evidence make a clinically important impact on our
conclusions about what to offer or tell our patients?
C.1. Is our patient so different from those in the study that
itsresults 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 informour prognostic conclusions.
C.2 Will this evidence make a clinically important impact on
our conclusions about what to offer or tell our patients?
• Useful for
• 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
Conclusion
• Prognosis study beneficial
• Communicating to patients their likely fate
• Guiding treatment decisions
• Comparing outcomes to make inferences about the quality of care
Exercise Critical Appraisals of A Prognostic Study
Answerable question (PICO)
• P – Patients hospitalized due to CAP
• I – Several prognostic factors (age, cardiovascular disease,
immunocompromization, low serum albumin level on admission,
active smoking, microbial etiology)
• C – No risk factors
• O – Long-term (5-year) mortality
APPLICATION
• Were the study patients similar to your own? Or: Are the study
patients so different from ours that we should not use the results at
all in making predictions for our patients?
• Will this evidence make a clinically important impact on your
conclusions about what to offer or tell your patient?
