Table 1.
Minimum target and achieved recruitment quotas
| Criteria | Target (N = 60) | Actual (N = 66)* |
|---|---|---|
| Age (years) | ||
| Caregiver of child 3–5 years | n = 1 | n = 6 |
| Caregiver of child 6–11 years | n = 1–2 | n = 9 |
| Child (6–11 years) | n = 3–4 | n = 8 |
| Adolescent (12–17 years) | n = 3–4 | n = 10 |
| Adult (18 years and over) | n = 3–4 | n = 33 |
| RP genotype | ||
| RLBP1 RP | n = 1–2 | n = 8 |
| RPE65 RP | n = 1–2 | n = 1 |
| RPE65 LCA | n = 1–2 | n = 12 |
| X-linked/RPGR RP | n = 1–2 | n = 16 |
| PRPF31 RP | n = 1–2 | n = 2 |
| Rhodopsin gene (RHO) | n = 1–2 | n = 2 |
| Patient-reported severity of RP | ||
| Very mild | n = 1–2 | n = 0 |
| Mild | n = 1–2 | n = 6 |
| Moderate | n = 1–2 | n = 17 |
| Severe | n = 1–2 | n = 17 |
| Very severe | n = 1–2 | n = 10 |
| Visual acuity* score of the left eye | ||
| Mild (> 60 letters) | n = 1–2 | n = 21 |
| Moderate (36–60 letters) | n = 1–2 | n = 13 |
| Severe (5–35 letters) | n = 1–2 | n = 11 |
| Very severe (< 5 letters) | n = 1–2 | n = 10 |
| N/A (blind) | N/A | n = 2 |
| Visual acuity* score of the right eye | ||
| Mild (> 60 letters) | n = 1–2 | n = 24 |
| Moderate (36–60 letters) | n = 1–2 | n = 13 |
| Severe (5–35 letters) | n = 1–2 | n = 10 |
| Very severe (< 5 letters) | n = 1–2 | n = 7 |
| N/A (blind) | N/A | n = 2 |
n = 1 caregiver was included in the total sample twice, as they were interviewed separately about their two children with RP/LCA. For the concept elicitation interviews, counts were included for each child separately however, the caregiver only completed the cognitive debriefing of the ViSIO-ObsRO once
*Visual acuity score as defined by ETDRS (Early Treatment Diabetic Retinopathy Study) letter score (if every letter read correctly on that line and all lines above it on the chart) [26]