Table 14:

GRADE Evidence Profile for Quality of Life After MRgFUS Neurosurgery

Number of Studies (Design)	Risk of Bias	Inconsistency	Indirectness	Imprecision	Publication Bias	Upgrade Considerations	Quality
Compared With Sham
1 (RCT)38	No serious limitations	No serious limitationsa	No serious limitations	No serious limitationsb	Undetecteda	NA	⊕⊕⊕⊕ High
Compared With Deep Brain Stimulation
1 (Observational)40	Serious limitations (−1)c	No serious limitationsa	No serious limitations	Serious limitations (−1)d	Undetecteda	NA	⊕ Very Low
MRgFUS Only
3 (Observational)37,42,45	No serious limitationse	No serious limitationsa	No serious limitations	No serious limitationsf	Undetecteda	NA	⊕⊕ Low

Abbreviations: MRgFUS, magnetic resonance-guided focused ultrasound; NA, not applicable; RCT, randomized controlled trial.

^aCannot definitively assess presence or absence because the evidence is derived from a single study.

^bAbsolute change and relative improvement are both clinically meaningful and statistically significant.

^cRisk of bias was highest owing to retrospective data collection methods. The full risk-of-bias assessment is presented in Appendix 2, Table A2.

^dConsiderable imbalance in group sizes for comparisons, optimal information size criteria not met, no measures of variance or confidence intervals provided; therefore, uncertainty remains in the precision of estimates.

^eRisk of bias judged to be low for all considerations except participant selection, which was unclear. The full risk-of-bias assessment is presented in Appendix 2, Table A2.

^fStatistical power an issue in one study; however, a clinically meaningful and statistically significant, large effect was found.