Fungal Infection-Related Mortality in Antifungal Trials
Author Information
Author(s): Anne K Due, Helle K Johansen, Peter C Gøtzsche
Primary Institution: Nordic Cochrane Centre, Rigshospitalet
Hypothesis
Does the use of fungal infection-related mortality as an outcome rather than total mortality lead to bias in trials of antifungal agents in cancer patients?
Conclusion
Using fungal mortality as the primary outcome in antifungal trials seems reliable, but total mortality data should also be reported to avoid potential harmful treatments.
Supporting Evidence
- Thirty trials met the inclusion criteria, comprising 6130 patients and 869 deaths.
- 220 deaths (25%) were ascribed to fungal infection.
- The relative risk of death was lower for total mortality compared to fungal mortality.
Takeaway
This study looked at whether counting deaths from fungal infections instead of all causes could make antifungal treatments look better than they are. It found that counting fungal deaths is okay, but we should still look at all deaths too.
Methodology
The study analyzed data from 69 trials included in four systematic reviews, focusing on relative risks of death in patients with cancer and neutropenia.
Potential Biases
There may be a risk of misclassification of cause of death, particularly in trials that were not blinded.
Limitations
The study's findings may not apply to future antifungal agents, and the confidence interval suggests the possibility of minor bias.
Participant Demographics
Patients with cancer and neutropenia at risk for fungal infections.
Statistical Information
P-Value
0.85 for total mortality, 0.57 for fungal mortality, 0.95 for mortality among those who did not die from fungal infection.
Confidence Interval
95% CI 0.75–0.96 for total mortality, 95% CI 0.44–0.74 for fungal mortality, 95% CI 0.82–1.09 for mortality among those who did not die from fungal infection.
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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