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What are the Results of 
This Harm Study? 
How strong is the association between 
exposure and outcome? What’s the 
risk? 
Terry Shaneyfelt, MD, MPH 
Associate Professor of Medicine 
UAB School of Medicine 
ebmteacher.com
Outcome measures of observational 
studies 
• Cohort Studies 
– Relative risk or risk ratio (RR) 
• Case-control Studies 
– Odds ratio (OR)
Relative Risk (Risk Ratio) 
• Expresses how many times more (or less) 
likely an exposed person develops an 
outcome relative to an unexposed person 
• Interpretation: 
– RR > 1 Increased risk of outcome 
– RR = 1 No risk of outcome 
– RR < 1 Reduced risk of outcome
What is the correct interpretation 
of a RR of 1.36? 
1. Risk of disease is increased by 136% 
2. Risk of disease is reduced by 36% 
3. Risk of exposure is reduced by 36% 
4. Risk of exposure is increased by 36% 
5. Risk of disease is increased by 36% 
6. Risk of exposure is increased by 136%
2 more 
1. What is the interpretation of a RR of 0.80? 
– Risk of the outcome in the exposed group was reduced 
by 20% (or occurred 20% less) relative to the 
unexposed group. 
2. What is the interpretation of a RR of 3.30? 
– Risk of the outcome in the exposed group was increased 
by 230% relative to the unexposed group or the 
outcome was 3.3 times more likely to occur in the 
exposed group than in the unexposed group.
Don’t be fooled…It’s all relative 
• RR = 3 (3 times more likely to develop the 
outcome if you are exposed to X) 
– Are you impressed? 
– Yes if started at 30%  90% 
– Not so much if start at 0.1%  0.3% 
• Have to assess baseline risk of your patient 
and then apply the RR
NEJM 1996;335:453
Odds Ratio 
• How many times more likely the odds of finding 
an exposure in someone with disease is compared 
to finding the exposure in someone without the 
disease 
• Interpretation: 
– OR > 1 Increased frequency of exposure among cases 
– OR = 1 No change in frequency of exposure 
– OR < 1 Decreased frequency of exposure
How big should the RR or OR be for 
us to be impressed? 
• In a RCT we would be satisfied with a small 
increase (or decrease) in risk 
• Cohort study: RR > 3 for a minor adverse event 
• Case-control: OR > 4 
From: EBM How to Practice and Teach It 4th ed. Pg 195
Prof Les Irwig’s Suggested rule of thumb 
of when to trust the RR or OR 
• Compare the unadjusted RR or OR to one in 
which at least 1 known confounder was 
adjusted out 
• If adjustment produces a large decline in the OR 
or RR be suspicious of a spurious association 
• In contrast, if the adjustment increases the RR 
or OR or if it remains stable then we can be 
more confident in the validity of the association. 
From: EBM How to Practice and Teach It 4th ed. Pg 195
NEJM 1996;335:453 
Unadjusted RR = (8/27161) ÷ (431/304744) = 0.208

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What does an odds ratio or relative risk mean?

  • 1. What are the Results of This Harm Study? How strong is the association between exposure and outcome? What’s the risk? Terry Shaneyfelt, MD, MPH Associate Professor of Medicine UAB School of Medicine ebmteacher.com
  • 2. Outcome measures of observational studies • Cohort Studies – Relative risk or risk ratio (RR) • Case-control Studies – Odds ratio (OR)
  • 3. Relative Risk (Risk Ratio) • Expresses how many times more (or less) likely an exposed person develops an outcome relative to an unexposed person • Interpretation: – RR > 1 Increased risk of outcome – RR = 1 No risk of outcome – RR < 1 Reduced risk of outcome
  • 4. What is the correct interpretation of a RR of 1.36? 1. Risk of disease is increased by 136% 2. Risk of disease is reduced by 36% 3. Risk of exposure is reduced by 36% 4. Risk of exposure is increased by 36% 5. Risk of disease is increased by 36% 6. Risk of exposure is increased by 136%
  • 5. 2 more 1. What is the interpretation of a RR of 0.80? – Risk of the outcome in the exposed group was reduced by 20% (or occurred 20% less) relative to the unexposed group. 2. What is the interpretation of a RR of 3.30? – Risk of the outcome in the exposed group was increased by 230% relative to the unexposed group or the outcome was 3.3 times more likely to occur in the exposed group than in the unexposed group.
  • 6. Don’t be fooled…It’s all relative • RR = 3 (3 times more likely to develop the outcome if you are exposed to X) – Are you impressed? – Yes if started at 30%  90% – Not so much if start at 0.1%  0.3% • Have to assess baseline risk of your patient and then apply the RR
  • 8. Odds Ratio • How many times more likely the odds of finding an exposure in someone with disease is compared to finding the exposure in someone without the disease • Interpretation: – OR > 1 Increased frequency of exposure among cases – OR = 1 No change in frequency of exposure – OR < 1 Decreased frequency of exposure
  • 9. How big should the RR or OR be for us to be impressed? • In a RCT we would be satisfied with a small increase (or decrease) in risk • Cohort study: RR > 3 for a minor adverse event • Case-control: OR > 4 From: EBM How to Practice and Teach It 4th ed. Pg 195
  • 10. Prof Les Irwig’s Suggested rule of thumb of when to trust the RR or OR • Compare the unadjusted RR or OR to one in which at least 1 known confounder was adjusted out • If adjustment produces a large decline in the OR or RR be suspicious of a spurious association • In contrast, if the adjustment increases the RR or OR or if it remains stable then we can be more confident in the validity of the association. From: EBM How to Practice and Teach It 4th ed. Pg 195
  • 11. NEJM 1996;335:453 Unadjusted RR = (8/27161) ÷ (431/304744) = 0.208