A planned noninferiority test is not a finding of equal safety.
The protocol proposed 692 older elective spinal-surgery patients receiving midazolam or placebo during induction. Postoperative delirium over days one through three was the primary outcome. The planned margin was nine percentage points, and long-term benzodiazepine users and patients with severe cognitive impairment were excluded.
No comparative results were reported. The margin determines what difference the future analysis may accept and requires clinical justification. Exclusions mean that even a successful trial would not automatically answer the question for chronic users or severe cognitive impairment.
For expert review, report the margin, confidence interval and analysis population when results become available. Do not describe a protocol’s hypothesis as evidence that midazolam causes no additional delirium. A noninferiority conclusion would also differ from proof of identical event rates.
Source: Publication PMC12880649. The case-review applications above are interpretive analysis.
Related reading: Thai Herbal Insomnia Trial’s Lorazepam Comparison Was Short and Margin-Dependent.