- Representation of pragmatic use of treatment (real life)
- Despite the power of the study and the well-conducted statistical analysis with propensity score, it does not replace a double-blind randomized controlled trial.
- One may question the reliability of data extracted automatically by computer from manually completed medical records (even though "The Surgical Outcomes Collaborative" is a regularly used registry, "The Surgical Outcomes Collaborative" is a registry that has been used for many years).
- Control group not strictly comparable
- No QT interval measurement or recording of peak torsades e.g. to distinguish the most severe arrhythmias from others
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