Joint Distribution Approaches to Quantifying Benefit and Risk
Author Information
Author(s): Michele L. Shaffer, Kristi L. Watterberg
Primary Institution: Penn State College of Medicine
Hypothesis
How do you appropriately measure the tradeoff between the benefit and risk of two therapies?
Conclusion
The joint distribution of benefit and risk should be shown alongside the benefit-risk ratio to avoid ambiguity.
Supporting Evidence
- The study analyzed data from the PROPHET trial, which involved 360 infants.
- The benefit-risk ratio for the subgroup of infants exposed to chorioamnionitis was found to be 1.52.
- The study showed a 72% chance of a positive incremental net benefit if hydrocortisone is used.
Takeaway
This study looks at how to balance the good and bad effects of treatments for babies, showing that sometimes more babies can survive but with some risks.
Methodology
The study used Bayesian methodology to analyze data from a clinical trial comparing hydrocortisone to placebo in infants.
Limitations
The confidence interval for the benefit-risk ratio is wide, indicating uncertainty in the results.
Participant Demographics
Infants with extremely low birth weight (500–999 grams) in a multicenter trial.
Statistical Information
Confidence Interval
0.23 to 5.25
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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