Recommendations

The IDEAL collaboration has endorsed a number of suggestions for specific study designs and reporting standards which are recommended at different stages in the Framework. These suggestions are underpinned by a series of general principles for design and reporting, which are based on the different questions to be addressed and the challenges faced at each stage in the process

Study design and reporting ideas for improving evidence on surgical and interventional therapy innovation.

INNOVATION STAGE

  • Online registry for first-in-man innovations

DEVELOPMENT STAGE

  • Prospective development studies
  • Protocol and study registries for prospective development studies in surgery
  • Development of agreed reporting standards and definitions for key outcomes

EXPLORATION STAGE

  • Prospective research databases
  • “Phase 2S “ prospective collaborative studies
  • Reporting of continuous quality control measures (eg, CUSUM  stages 2b to 4)

ASSESSMENT STAGE

Alternatives to randomised clinical trials

  • Case-matching studies
  • Controlled interrupted-time series designs
  • Step-wedge designs

Modified randomised clinical trials

  • Randomisation variants: expertise-based, third party
  • Tracker trials
  • Phase 2S transition from database to randomised clinical trial
  • Feasibility randomised clinical trial (where study size and endpoints are aimed at determining the feasibility of a definitive study)
  • Explanatory randomised clinical trial (where contextual confounders are minimised to ensure the best possible comparison between experimental and control treatments)

Additions to randomised clinical trials

  • Learning curve evaluation
  • Quality control and compliance measures

LONG TERM STUDY STAGE

  • Registries for surveillance of specific established techniques

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