Table A1:
GRADE Evidence Profile for Comparison of the Argus II Retinal Prosthesis System On and Off
| Number of Studies (Design) | Risk of Bias | Inconsistency | Indirectness | Imprecision | Publication Bias | Upgrade Considerations | Quality |
|---|---|---|---|---|---|---|---|
| Visual Function: Object Localization | |||||||
| 1 (observational)19 | No serious limitationsa | No serious limitations | No serious limitations | No serious limitations | Undetected | Underlying trajectory of retinitis pigmentosa (+1)b | ⊕⊕⊕ Moderate |
| Visual Function: Direction of Motion | |||||||
| 1 (observational)19 | No serious limitationsa | No serious limitations | No serious limitations | No serious limitations | Undetected | Underlying trajectory of retinitis pigmentosa (+1)b | ⊕⊕⊕ Moderate |
| Visual Function: Grating Visual Acuity | |||||||
| 1 (observational)19 | No serious limitationsa | No serious limitations | No serious limitations | No serious limitations | Undetected | Underlying trajectory of retinitis pigmentosa (+1)b | ⊕⊕⊕ Moderate |
| Functional Outcomes: Orientation and Mobility (Find the Door) | |||||||
| 1 (observational)19 | No serious limitationsa | No serious limitations | No serious limitations | No serious limitations | Undetected | Underlying trajectory of retinitis pigmentosa (+1)b | ⊕⊕⊕ Moderate |
| Functional Outcomes: Orientation and Mobility (Follow the Line) | |||||||
| 1 (observational)19 | No serious limitationsa | No serious limitations | No serious limitations | No serious limitations | Undetected | Underlying trajectory of retinitis pigmentosa (+1)b | ⊕⊕⊕ Moderate |
| Functional Outcomes: Visual Orientation | |||||||
| 1 (observational)8 | No serious limitationsa | No serious limitations | No serious limitations | No serious limitations | Undetected | Underlying trajectory of retinitis pigmentosa (+1)b | ⊕⊕⊕ Moderate |
| Functional Outcomes: Visual Mobility | |||||||
| 1 (observational)8 | No serious limitationsa | No serious limitations | No serious limitations | No serious limitations | Undetected | Underlying trajectory of retinitis pigmentosa (+1)b | ⊕⊕⊕ Moderate |
| Functional Outcomes: Daily Life | |||||||
| 1 (observational)8 | No serious limitationsa | No serious limitations | No serious limitations | No serious limitations | Undetected | Underlying trajectory of retinitis pigmentosa (+1)b | ⊕⊕⊕ Moderate |
| Functional Outcomes: Interaction With Others | |||||||
| 1 (observational)8 | No serious limitationsa | No serious limitations | No serious limitations | No serious limitations | Undetected | Underlying trajectory of retinitis pigmentosa (+1)b | ⊕⊕⊕ Moderate |
| Functional Outcomes: Sock Sorting | |||||||
| 1 (observational)21 | No serious limitationsa | No serious limitations | No serious limitations | No serious limitations | Undetected | Underlying trajectory of retinitis pigmentosa (+1)b | ⊕⊕⊕ Moderate |
| Functional Outcomes: Sidewalk Tracking | |||||||
| 1 (observational)21 | No serious limitationsa | No serious limitations | No serious limitations | No serious limitations | Undetected | Underlying trajectory of retinitis pigmentosa (+1)b | ⊕⊕⊕ Moderate |
| Functional Outcomes: Walking Direction Discrimination | |||||||
| 1 (observational)21 | No serious limitationsa | No serious limitations | No serious limitations | No serious limitations | Undetected | Underlying trajectory of retinitis pigmentosa (+1)b | ⊕⊕⊕ Moderate |
| Quality of Life: Injury | |||||||
| 1 (observational)20 | No serious limitationsa | No serious limitations | No serious limitations | No serious limitations | Undetected | Underlying trajectory of retinitis pigmentosa (+1)b | ⊕⊕⊕ Moderate |
| Quality of Life: Life | |||||||
| 1 (observational)20 | No serious limitationsa | No serious limitations | No serious limitations | No serious limitations | Undetected | Underlying trajectory of retinitis pigmentosa (+1)b | ⊕⊕⊕ Moderate |
| Quality of Life: Assistance | |||||||
| 1 (observational)20 | No serious limitationsa | No serious limitations | No serious limitations | No serious limitations | Undetected | Nonec | ⊕⊕ Low |
| Quality of Life: Roles | |||||||
| 1 (observational)20 | No serious limitationsa | No serious limitations | No serious limitations | No serious limitations | Undetected | Underlying trajectory of retinitis pigmentosa (+1)b | ⊕⊕⊕ Moderate |
| Quality of Life: Activity | |||||||
| 1 (observational)20 | No serious limitationsa | No serious limitations | No serious limitations | No serious limitations | Undetected | Underlying trajectory of retinitis pigmentosa (+1)b | ⊕⊕⊕ Moderate |
Abbreviation: GRADE, Grading of Recommendations Assessment, Development, and Evaluation.
a
Observational studies started with a low GRADE level because of inherent limitations in study design (e.g., lack of randomization, lack of blinding, and loss to follow-up). We did not lower the GRADE level further unless there were more substantial study limitations.
b
The natural history of retinitis pigmentosa is a progressive deterioration of vision, eventually leading to blindness. The Argus II retinal prosthesis system is the only treatment option currently available to restore partial functional vision for these patients.
c
Not upgraded for the assistance domain because of large standard error and small sample size (i.e., imprecision).