Table 7:

GRADE Evidence Profile for Vision-Related Quality of Life, 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
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
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
Assistance
1 (observational)20	No serious limitationsa	No serious limitations	No serious limitations	No serious limitations	Undetected	Nonec	⊕⊕ Low
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
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.

^aObservational 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.

^bThe 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.

^cNot upgraded for the assistance domain because of large standard error and small sample size (i.e., imprecision).