Table A7:
GRADE Evidence Profile for Comparison of GeneSight-Guided Treatment Selection With Treatment as Usual—Change in Depression Score
| No. of Studies (Design) | Risk of Bias | Inconsistency | Indirectness | Imprecision | Publication Bias | Upgrade Considerations | Quality |
|---|---|---|---|---|---|---|---|
| 17-Item Hamilton Depression Rating Scale | |||||||
| 2 (RCTs) | Very serious limitations (−;2)a | No serious limitationsb | No serious limitationsc | Serious limitations (−;1)d,e | Undetected | None | ⊕ Very low |
| 2 (observational) | Serious limitations (−;1)a | No serious limitationsb | No serious limitationsc | Serious limitations (−;1)d,f | Undetected | None | ⊕ Very low |
| 16-item Quick Inventory of Depressive Symptomatology | |||||||
| 2 (RCTs) | Very serious limitations (−;2)a | No serious limitationsb | No serious limitationsc | Serious limitations (−;1)d | Undetected | None | ⊕ Very low |
| 2 (observational) | Serious limitations (−;1)a | No serious limitationsb | No serious limitationsc | Serious limitations (−;1)d,f | Undetected | None | ⊕ Very low |
| 9-Item Patient Health Questionnaire | |||||||
| 2 (RCTs) | Very serious limitations (−;2)b | No serious limitationsb | No serious limitationsc | Serious limitations (−;1)d | Undetected | None | ⊕ Very low |
| 1 (observational) | Serious limitations (−;1)a | Noneg | No serious limitationsc | Serious limitations (−;1)d,f | Undetected | None | ⊕ Very low |
| 6-Item Hamilton Depression Rating Scale | |||||||
| 1 (RCT) | Very serious limitations (−;2)a | Noneg | No serious limitationsc | Serious limitations (−;1)d | Undetected | None | ⊕ Very low |
Abbreviations: GRADE, Grading of Recommendations Assessment, Development, and Evaluation; RCT, randomized controlled trial.
See Risk of Bias Table A5 and Table A6. Observational studies begin at low quality GRADE and were not downgraded further owing to very serious risk of bias issues.
Insufficient data were available to judge consistency of data between studies.
Only percent changes from baseline were reported, which did not allow for assessment of clinically meaningful differences in mean scores.
No measures of variance were reported and therefore they could not be appropriately assessed.
Based on data from the larger RCT by Greden et al, estimated effect estimates did not meet the clinically meaningful threshold of a 2- to 3-point difference in mean HAM-D scores.
Study sample sizes were small and unlikely to meet optimal information size.
Not evaluable owing to single study.