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

Table 1 Schedule of assessments

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
MADRS	X			X	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
WPAI:D	X			X	X
LAPS	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

^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
^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
^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
^d Antidepressant medications and psychotropics, ECT, rTMS, and/or psychotherapy (such as interpersonal therapy and cognitive behavioural therapy)
^e Including participant satisfaction record (if applicable)

ISSN: 1471-244X