Table 1

IDEAL Compliance Appraisal tool

StageDomainsOption
Stage 1Idea
Item 1Was the patient selection process fully described.□Yes □Partial Yes □No
Item 2Did the study fully describe the procedure of interest.□Yes □Partial Yes □No
Item 3Did the study clearly state the rationale for the innovation.□Yes □Partial Yes □No
Item 4Did the study appropriately report relevant outcome measures.□Yes □Partial Yes □No
Stage 2aDevelopment
Item 1Did the study fully describe the patient selection process as used in the first case in the 2a study.□Yes □Partial Yes □No
Item 2Did the study describe the procedure of interest as it was performed in the first case in the 2a study.□Yes □Partial Yes □No
Item 3Did the study report all changes in the design, use of the device or the way of performing the procedure.□Yes □Partial Yes □No
Item 4Did the study report key outcome measures sequentially (case by case) to allow evaluation of change.□Yes □No
Item 5Did the study state if the innovation stable enough to move to stage 2b.□Yes □Partial Yes □No
Stage 2bAssessment
Item 1Was there a unified description of the intervention and accepted variation.□Yes □Partial Yes □No
Item 2Did the study define the measures used to evaluate the quality of the procedure or device use.□Yes □No
Item 3Did the study provide information about the learning curve assessment.□Yes □Partial Yes □No
Item 4Did the study provide a qualitative evaluation of the stakeholder values.□Yes □Partial Yes □No
Item 5Did the study describe a pre-planned review of results and discussion to achieve the agreement on the stage 3 trial.□Yes □Partial Yes □No
Item 6Did the study report the use of the primary outcome effect estimate to perform power calculations for possible RCTs.□Yes □No
Stage 4Long-term follow-up.
Item 1Did the study describe the data source.□Yes □No
Item 2Did the study clearly and precisely describe the definition of the dataset.□Yes □Partial Yes □No
Item 3Did the study conduct appropriate analysis of data.□Yes □Partial Yes □No
Item 4Did the study report the missing data of the dataset.□Yes □Partial Yes □No
  • RCT, randomised controlled trial.