Table 5.

Recommendations for the Study Design of New Trials

Recommendations for new studies
Quality of the study	1. Controlled design (comparison with standard treatment or placebo) 2. Randomized 3. Minimal follow-up duration of 12 months 4. Following CONSORTa statement for reporting 5. Statistically testing for differences between groups
Standardization of the procedure	1. Standardized harvesting, processing and injection technique 2. Standardized injection volume and volume-to-volume ratio of supplement-to-fat graft 3. No concomitant procedures (eg, facelift) that can influence volume or satisfaction outcomes 4. Single injections, no repeated procedures
Measurement of volume retention	1. Clear definition of how retention is measured, based on injected volume or based on first volume measurement after surgery 2. Using valid imaging modalities (without ionizing radiation) 3. Using a reliable method of volume measurement, by either reporting reliability or using a validated method of volume measurement
Measurement of patient satisfaction	1. Using a validated PROMb 2. Measuring change of PROM, including a preoperative (baseline) measurement 3. Statistically testing for difference of PROM between intervention and control group 4. Observer/surgeon should not be present when PROM is recorded, to exclude interviewer/social desirability bias

^aConsolidated Standards of Reporting Trials.

^bPatient-reported outcome measures.