Recommendations

IDEAL recommendations for study design and reporting in order to improve evidence on surgical and interventional therapy innovation.

Integrated pathwayThe 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

IdeaINNOVATION STAGE

  • Online registry for first-in-man innovations

DevelopmentDEVELOPMENT STAGE

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

ExplorationEXPLORATION STAGE

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

AssessmentASSESSMENT 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
  • 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 studyLONG TERM STUDY STAGE

  • Registries for surveillance of specific established techniques