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Table 5 Presenting the distribution of baseline risk in clinical trials

From: Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal

 

Frequency

(%)

Predicted Risk*

Control

(N = 200)

Intervention

(N = 200)

Total

(N = 400)

< 5%

69 (34.5%)

69 (34.5%)

138 (34.5%)

5%-15%

90 (45.0%)

95 (47.5%)

185 (46.3%)

> 15%

41 (20.5%)

36 (18.0%)

77 (19.3%)

Mean + SD

9.2 (8.6)

9.8 (9.3)

9.5 (9.0)

Median (Q1 - Q3)

6.4 (3.7-10.9)

7.0 (3.6-11.9)

6.8 (3.6-11.3)

EQuRR**

-

-

12.4

  1. * Presenting results so that reader can easily observe whether the relative risk reduction or number needed to treat vary based upon the individuals baseline risk of the outcome. In this example, the risk model is expressed as predicted risk (%). However, presentation of results stratified according to a risk score would be similarly informative.
  2. ** Extreme quartile risk ratio, the predicted risk in the highest risk quartile divided by the risk in the lower risk quartile
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Trials

ISSN: 1745-6215