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Table 1 Schedule of assessments

From: Vagus nerve stimulation as adjunctive therapy in patients with difficult-to-treat depression (RESTORE-LIFE): study protocol design and rationale of a real-world post-market study

Visits Baseline Implant (Day 0) Titration visits (as needed following implant) Follow-up visits (at 3, 6, 9, 12, 15, 18, 24, 30, and 36 months) a] Long-term follow-up (every 6 months until 60 months or study ends)
Allowed visit window 6 weeks to 1 week before implant n/a n/a ± 45 days ± 60 days
Informed consent X     
Assessment of eligibility criteria X     
VNS Therapy implant/revision/explant   X As needed
VNS Therapy parameter settings   X X X X
Device deficiency monitoring (if applicable)   X X X X
Study assessments      
MINI X     
Modified ATHF X     
Medical history, demographics, and baseline patient characteristics X     
QIDS-SR (not collected at 3, 9, and 15 months) X    X X
Q-LES-Q-SF (not collected at 3, 9, and 15 months) X    X X
EQ-5D-5L (not collected at 3, 9, and 15 months) X    X X
ASRM b X    X X
Cognition test (THINC-it®) (not collected at 3, 9, and 15 months) b X    X X
GAD-7 (not collected at 3, 9, and 15 months) b X    X X
Health Care Utilization Form (not collected at 3, 9, and 15 months) c X    X X
Antidepressant treatments d X    X X
Adverse events monitoring X X X X X
Study completion/termination record e    At study exit
  1. a QIDS-SR, Q-LES-Q-SF, EQ-5D-5L, THINC-it, GAD-7, and Health Care Utilization Form are not collected at 3, 9, and 15 months
  2. bThe ASRM, THINC-it, and GAD-7 are optional assessments to be completed at selected sites only and will be upto the investigators’ clinical judgment to decide which participants complete the assessments
  3. cHealth care utilization data (eg, number of depression-related emergency room visits and/or hospitalizations) will be obtained where possible (patient reported and/or based on medical records, whichever is available). More detailed information may be derived from a national health care database, if available, and if the patient provides consent to collect this data
  4. d Antidepressant medications and psychotropics, ECT, rTMS, and/or psychotherapy (such as interpersonal therapy and cognitive behavioural therapy)
  5. e Including participant satisfaction record (if applicable)