Table 2.

Proposals for modified study designs for surgical techniques

Proposals for modified study designs for evaluating surgical techniques
Phase 1	Interrupted time series/industrial quality improvement hybrid. Planned repetitive Bayesian analysis and modification.
Phase 2	Development of reporting standards for surgical case series.
Phase 2	Phase IIS prospective non-randomized study progressing to RCT.
Phase 3	Modified RCT with operation definition, quality control, learning curve documentation.
Phase 4	Continuous performance monitoring using statistical process control.