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. 2021 Aug 12;21(13):1–214.

Table A11:

GRADE Evidence Profile for Comparison of GeneSight-Guided Treatment Selection and Treatment as Usual—Response

No. of Studies (Design) Risk of Bias Inconsistency Indirectness Imprecision Publication Bias Upgrade Considerations Quality
Response Based on HAM-D17
2 (RCTs) Very serious limitations (−;2)a No serious limitations No serious limitations No serious limitations Undetected None ⊕⊕ Low
1 (observational) Serious limitations (−;1)a No serious limitations No serious limitations Serious limitations (−;1)b Undetected None ⊕ Very Low
Response Based on QIDS-C16
1 (RCTs) Very serious limitations (−;2)a No serious limitations No serious limitations Serious limitations (−;1)c Undetected None ⊕ Very Low
1 (observational) Serious limitations (−;1)a No serious limitations No serious limitations Serious limitations (−;1)b Undetected None ⊕ Very Low
Response Based on 9-Item Patient Health Questionnaire
1 (RCTs) Very serious limitations (−;2)b No serious limitations No serious limitations No serious limitations Undetected None ⊕⊕ Low
1 (observational) Serious limitations (−;1)a No serious limitations No serious limitations Serious limitations (−;1)b Undetected None ⊕ Very Low
Response Based on HAM-D6
1 (RCT) Very serious limitations (−;2)a No serious limitations No serious limitations No serious limitations Undetected None ⊕⊕ Low

Abbreviations: GRADE, Grading of Recommendations Assessment, Development, and Evaluation; HAM-D6, 6-item Hamilton Depression Rating Scale; HAM-D17, 17-item Hamilton Depression Rating Scale; QIDS-C16, 16-Item Quick Inventory of Depressive Symptomatology (clinician-rated); RCT, randomized controlled trial.

a

See Risk of Bias Tables A5 and A6. Observational studies begin at low-quality GRADE and were not downgraded further owing to very serious risk of bias issues.

b

Study had a small sample size, and number included at follow-up did not meet sample size calculation.

c

Effect estimate crosses null effect including both benefit and harm in effect.