Table 1

Breakdown of key considerations used to determine ideal Stage 6

Characteristics of reportsKey issues addressed and content itemsKey milestones for stage completion
Idea (1) One or very few reports
 Appears to be the earliest or near earliest report
 Only case reports or very small case series
 States that this is first in humans
 Detailed technical description
 Reports an intervention not previously used in human
Development (2a) Small number of reports
 Reports from one or a few centers
 All reports have small number of patients
 Nearly all reports are case series
 Safety of procedure
 Short-term outcomes
 Discusses indications
 Discusses technical detail and may describe modifications
 Content and nature of reports suggest intervention technique has reached stability
Exploration (2b) Increasing number of
 Patients per report
 Centers involved
 Some prospective collaborative studies (registries, audits, databases)
 Discusses procedural quality
 Discusses learning curves
 Comparison of outcomes with standard treatment
 Calls for an RCT to be done
Reports suggest that consensus has been reached on optimal technique, indications and outcome measures
Assessment (3) Reports of multicenter RCTs
 Quasi-experimental designs
 Stepped-wedge designs
 Case-matching studies
 Analysis of large data sets with risk adjustment
 Compares procedure with standard treatmentReports document a high-quality RCT or other valid experimental comparison of the intervention compared with the current standard of care
Long-term (4) Long-term cohort studies
 Retrospective case series
 Registries and databases
 Analyses of large administrative data sets
 No recent RCTs
 Reports long-term outcomes
 Identifies rare outcomes
 May analyze risk or prognostic factors
 May report on changing indications
 Ongoing reports of
 late or rare outcomes
 Which patients benefit most
 Whether indications are changing
 Variation in performance
  • RCT, randomized clinical trial; .