Table A22:
GRADE Evidence Profile for Comparison of Pharmacogenomic-Guided Treatment Selection With Treatment as Usual—Side Effects and Adverse Events
| No. of Studies (Design) | Risk of Bias | Inconsistency | Indirectness | Imprecision | Publication Bias | Upgrade Considerations | Quality |
|---|---|---|---|---|---|---|---|
| GeneSight—Mean Side Effects | |||||||
| 1 (RCT) | Very serious limitations (−;2)a | No serious limitations | No serious limitations | No serious limitations | Undetected | None | ⊕⊕ Low |
| Neuropharmagen—FIBSER Scores | |||||||
| 2 (RCTs) | Serious limitations (1)a | No serious limitationsb | No serious limitations | Serious limitations (1)c | Undetected | None | ⊕⊕ Low |
| Genecept—FIBSER Scores | |||||||
| 1 (RCT) | Serious limitations (1)a | No serious limitations | No serious limitations | No serious limitations | Undetected | None | ⊕⊕⊕ Moderate |
| CNSDose—Intolerability Rate | |||||||
| 1 (RCT) | Serious limitations (1)a | No serious limitations | No serious limitations | Serious limitations (1)d | Undetected | None | ⊕⊕ Low |
| Unspecified Test—Adverse Reactions | |||||||
| 1 (RCT) | Very serious limitations (−;2)a | No serious limitations | No serious limitations | Serious limitations (1)e | Undetected | None | ⊕ Very Low |
Abbreviations: FIBSER, Frequency, Intensity and Burden of Side Effects Rating; GRADE, Grading of Recommendations Assessment, Development, and Evaluation; RCT, randomized controlled trial.
See risk of bias tables in Appendix 7.
Insufficient data were provided by studies to calculate summary estimates and confidence intervals. Overall, summary estimates appeared to be consistent between studies except for FIBSER Frequency score. Given small uncertainty with both inconsistency and imprecision, only imprecision was downgraded.
Insufficient data were provided to calculate summary estimate and variance around all scores. Studies also differed in their reported measures of FIBSER. Given small uncertainty with both inconsistency and imprecision, only imprecision was downgraded.
Study had small sample size and likely was underpowered. Confidence intervals ranged from very small difference to large effect.
No point estimate could be calculated from data provided, and only a non-significant result was provided.