Why Are Clinicians Not Embracing the Results from Pivotal Clinical Trials in Severe Sepsis?
Author Information
Author(s): Kalil Andre C., Sun Junfeng
Primary Institution: University of Nebraska Medical Center
Hypothesis
What is the current probability that the new therapy is not better than the standard of care in my patient with severe sepsis?
Conclusion
The study shows that the strength of evidence for the five pivotal trials in severe sepsis is weak, particularly for the Low-Dose Steroid and Early Goal-Directed Therapy trials.
Supporting Evidence
- The analysis shows that the current probability of reducing death by a clinical threshold of RRR>15% is 88% for Intensive Insulin therapy.
- Results indicate that the strength of evidence is weak for all trials, particularly for Low-Dose Steroid and EGDT trials.
- Moderate and severe skeptic analyses show no clinically meaningful reduction in the risk of death for all trials.
Takeaway
Doctors are not using new treatments for severe sepsis even though studies show they can help, because they are unsure if these treatments are better than what they already do.
Methodology
Bayesian methodologies were applied to analyze the results of five pivotal clinical trials in severe sepsis.
Potential Biases
The study acknowledges potential biases in interpreting clinical trial results and the influence of prior negative evidence.
Limitations
The statistical approach may produce more conservative results than conventional methods, and the different sample sizes of each trial may influence the current probabilities.
Statistical Information
Confidence Interval
95% CI (0.13–0.62)
Digital Object Identifier (DOI)
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