Table 2.

Qualitative and quantitative outcome measures.

Outcomes		Qualitative measures	Quantitative measures
Participant-reported outcomes
	Impact of device on quality of life	Semistructured/unstructured interviews (in-person or by phone) at baseline and 12 months	Vision-related QoLa using the Impact of Vision Impairment-Very Low Vision validated questionnaire at baseline, 6 months, and 12 months. General health-related QoL measured using EQ-5D-5Lb and EQ-VASc questionnaires at baseline, 6 months, and 12 months.
	Device-related experience	Semistructured/unstructured interviews (in-person or by phone) at baseline and 12 months	Bespoke questionnaire, which includes questions about pain/discomfort from the device, perceived complications, satisfaction with the results of the procedure, satisfaction with rehabilitation, and overall impact of the device at 3 months, 6 months, and 12 months
	Psychological measures	N/Ad	HADSe-validated questionnaire at baseline, 6 months, and 12 months
Outcomes reported by rehabilitation staff
	Delivery/implementation of rehabilitation and device training	Semistructured interviews with rehabilitation staff to record rehabilitation and training strategies, fidelity of delivery, satisfaction with rehabilitation and training program, barriers and facilitators after 5 patients received Argus II and at the end of the study	N/A
	Impact of device on activities of daily living	Short “session report” by rehabilitation staff, which records number of visits, length of visit, and “training” strategies delivered at each visit	Semiquantitative: Visual function tests assessed by rehabilitation staff and recorded on an ordinal scale at baseline and 12 months
Clinical outcomes
	Safety outcomes	N/A	Procedural success All-cause adverse events and serious adverse events Management and outcome of adverse events Device explantation rate
	Visual function	N/A	Full-field stimulus light threshold Square localization test Direction of motion test Grating visual acuity test Landolt-C test
	Resource use	N/A	Proforma for clinical teams, including number of consultations, staff grade, length of procedure, additional interventions, adverse event management Rehabilitation use costed separately from device-related resource

^aQoL: quality of life.

^bEQ-5D-5L: 5-level EuroQoL 5-dimension scale.

^cEQ-VAS: EuroQoL visual analog scale.

^dN/A: not applicable.

^eHADS: Hospital Anxiety and Depression Scale.