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DOOR framework shows similar outcomes in skin infection trials
“Using DOOR can provide clinicians and patients with a better understanding of the benefits and risks of new anti-infectives being studied to treat skin infections.”
To evaluate the overall outcomes of omadacycline and linezolid in treating acute bacterial skin and skin structure infections using the DOOR framework.
Approach:
Study Design: Retrospective analysis of two randomized trials (OASIS-1 and OASIS-2) involving 1,347 participants.
DOOR Framework: Applied a patient-centered desirability of outcome ranking (DOOR) to assess treatment benefits and harms.
Patient Population: Included 627 patients from OASIS-1 and 720 from OASIS-2, focusing on survival and undesirable events.
Outcome Assessment: Patients ranked based on survival and events: absence of clinical response, infectious complications, and nonfatal serious adverse events.
Key Findings:
About 80% of patients in each trial had the most desirable DOOR outcome.
The DOOR probability for omadacycline was 50.6% in OASIS-1 (95% CI, 47.4%-53.7%) and 52.1% in OASIS-2 (95% CI, 49.2%-55.0%), indicating no significant difference between treatments.
In OASIS-2, quality-of-life scores slightly favored omadacycline but were not statistically significant.
No significant treatment differences were found for individual DOOR components.
Interpretation:
The DOOR framework provides a comprehensive understanding of treatment benefits and risks, showing similar outcomes for omadacycline and linezolid.
Limitations:
Data derived from only two trials funded by the same pharmaceutical company.
Serious adverse events and deaths were rare, complicating treatment distinction.
Post hoc review of infectious complications relied on coded data, potentially missing details.
Conclusion:
The DOOR framework is feasible and should be incorporated into future ABSSSI trials.
A retrospective cohort study of more than 520,000 hospitalized patients found no clinically meaningful improvement in deterioration or mortality with early treatment targeting community-acquired pneumonia.
