Question

Difficulty: MediumMeasures of Disease Frequency and Association

Public health researchers are analyzing data from a recent prospective cohort study investigating the adverse effects of a new oral synthetic retinoid used for severe nodular acne. The study followed 400400 patients taking the new retinoid and 400400 patients taking standard topical therapies for one year. During the study period, 5050 patients in the new retinoid group developed significantly elevated liver transaminases. In the standard therapy group, 1010 patients developed similar transaminase elevations. Based on these findings, what is the number needed to harm (NNH) for the new oral synthetic retinoid compared to standard therapy?

Answer: 10

Answer

10
The Number Needed to Harm (NNH) represents the number of patients who must be exposed to a risk factor (or treatment) over a specific period to cause one additional adverse outcome. It is calculated as the inverse of the Absolute Risk Increase (ARI), which is also known as the Attributable Risk. First, the incidence of the adverse event in the exposed group is 50/400=12.5%50/400 = 12.5\%. Next, the incidence in the unexposed group is 10/400=2.5%10/400 = 2.5\%. The ARI is the difference between these two incidences: 12.5%−2.5%=10%12.5\% - 2.5\% = 10\% (or 0.100.10). The NNH is calculated as 1/ARI1 / \text{ARI}, which is 1/0.10=101 / 0.10 = 10. Therefore, 1010 patients need to be treated with the new retinoid instead of standard therapy to cause one additional case of elevated liver transaminases.

Step-by-Step Solution

1
Calculate the incidence of elevated transaminases in the exposed group (new oral retinoid).
50/400=0.12550 / 400 = 0.125 or 12.5%12.5\%
To determine the absolute risk of the adverse event in patients receiving the new drug.
2
Calculate the incidence of elevated transaminases in the unexposed group (standard therapy).
10/400=0.02510 / 400 = 0.025 or 2.5%2.5\%
To determine the baseline absolute risk of the adverse event in patients not receiving the new drug.
3
Calculate the Absolute Risk Increase (ARI).
0.125−0.025=0.100.125 - 0.025 = 0.10 or 10%10\%
ARI represents the excess risk of the adverse event attributable to the new drug.
4
Calculate the Number Needed to Harm (NNH).
1/0.10=101 / 0.10 = 10
NNH is the inverse of the ARI, representing the number of patients who need to be treated for one additional adverse event to occur.

Key Concept

Number Needed to Harm (NNH) is calculated as the inverse of the Absolute Risk Increase (ARI) between an exposed and an unexposed group.
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