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