Table 10:
GRADE Evidence Profile for Functional Disability After MRgFUS Thalamotomy
| 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 | |||||||
| 1 (Observational)37 | 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.
Cannot definitively assess presence or absence because evidence is derived from a single study.
Study adequately powered; absolute change and relative improvement are both clinically meaningful and statistically significant.
Risk of bias was highest owing to retrospective data collection methods. The full risk-of-bias assessment is presented in Appendix 2, Table A2.
Considerable imbalance in group sizes for comparisons, optimal information size criteria not met, no measures of variance or confidence intervals provided; therefore, uncertainty remains in precision of estimates.
Risk 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.
Confidence interval for absolute difference in severity scores relatively narrow, mean difference and upper and lower bounds are clinically meaningful, as is relative improvement.