Question

Difficulty: MediumMeasures of Disease Frequency and Association

To evaluate a suspected link between maternal fluoxetine use and neonatal pulmonary hypertension, investigators identify 100 neonates diagnosed with this respiratory condition at a tertiary care center over a five-year period. For comparison, they randomly select 400 healthy neonates born at the same center during the same timeframe.

A retrospective review of maternal electronic health records reveals that 20 mothers of affected neonates and 40 mothers of healthy neonates were prescribed fluoxetine during their third trimester.

Which of the following is the most appropriate measure of association for these findings, and what is its calculated value?

  1. A
    Odds ratio of 0.440.44
  2. B
    Relative risk of 1.831.83
  3. Odds ratio of 2.252.25Answer
  4. D
    Relative risk of 2.002.00
  5. E
    Odds ratio of 2.002.00

Answer

Odds ratio of 2.252.25
The study design is a case-control study because participants were selected based on their disease status (neonatal pulmonary hypertension vs. healthy) and their past exposure (fluoxetine) was assessed retrospectively. In case-control studies, disease incidence cannot be measured because the investigator determines the number of cases and controls. Therefore, relative risk cannot be directly calculated. The appropriate measure is the odds ratio. The odds of exposure in cases is 20/8020/80 (which simplifies to 1/41/4). The odds of exposure in controls is 40/36040/360 (which simplifies to 1/91/9). The odds ratio is (1/4)÷(1/9)=9/4=2.25(1/4) \div (1/9) = 9/4 = 2.25.

Step-by-Step Solution

1
Identify the study design.
The study selects patients based on the presence of disease (neonatal pulmonary hypertension cases) or absence of disease (healthy controls) and looks retrospectively at exposure. This is a case-control study.
Identifying the study design determines which statistical measures of association can be legitimately calculated.
2
Determine the appropriate measure of association.
For a case-control study, the odds ratio (OR) is the appropriate measure. Relative risk (RR) requires incidence data, which case-control studies do not provide.
In case-control studies, the prevalence of the disease is artificially determined by the researchers (e.g., 100 cases to 400 controls). Therefore, true risk (incidence) cannot be calculated.
3
Extract data and calculate the odds of exposure in cases and controls.
Cases exposed = 2020, Cases unexposed = 100−20=80100 - 20 = 80. Odds of exposure in cases = 20/8020/80. Controls exposed = 4040, Controls unexposed = 400−40=360400 - 40 = 360. Odds of exposure in controls = 40/36040/360.
The odds ratio is the ratio of the odds of exposure among cases to the odds of exposure among controls.
4
Calculate the final Odds Ratio.
OR = (20/80)÷(40/360)=(1/4)÷(1/9)=9/4=2.25(20/80) \div (40/360) = (1/4) \div (1/9) = 9/4 = 2.25.
This yields the final value for the chosen measure of association.

Key Concept

In case-control studies, patients are selected based on outcome status, meaning disease incidence cannot be calculated. Therefore, the odds ratio (OR) is the correct measure of association, not relative risk (RR).
Estimated Time:1m 30s
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