Table A3:
GRADE Evidence Profile for Comparison of GeneSight-Guided Care and Usual Care
| Number of Studies (Design) | Risk of Bias | Inconsistency | Indirectness | Imprecision | Publication Bias | Upgrade Considerations | Quality |
|---|---|---|---|---|---|---|---|
| Remission of Depression Symptoms | |||||||
| HAMD-17 | |||||||
| 1 (RCT) 1 (observational) | Serious limitationsa | No limitations | No limitations | Serious limitationsb | None detected | None | ⊕ Very low |
| QIDS-C16 | |||||||
| 1 (observational) | Serious limitationsa | No limitations | No limitations | Serious limitationsb | None detected | None | ⊕ Very low |
| PHQ-9 | |||||||
| 1 (observational) | Serious limitationsa | No limitations | No limitations | Serious limitationsb | None detected | None | ⊕ Very low |
| Response to Depression Therapy | |||||||
| HAMD-17 | |||||||
| 1 (RCT) 2 (observational) | Serious limitationsa | No limitations | No limitations | No limitations | None detected | None | ⊕⊕ Low |
| QIDS-C16 | |||||||
| 1 (observational) | Serious limitationsa | No limitations | No limitations | Serious limitationsb | None detected | None | ⊕ Very low |
| PHQ-9 | |||||||
| 1 (observational) | Serious limitationsa | No limitations | No limitations | Serious limitationsb | None detected | None | ⊕ Very low |
| Depression Score | |||||||
| HAMD-17 | |||||||
| 1 (RCT) 2 (observational) | Serious limitationsa | No limitations | No limitations | Serious limitationsb | None detected | None | ⊕ Very low |
| QIDS-C16 | |||||||
| 2 (observational) | Serious limitationsa | No limitations | No limitations | Serious limitationsb | None detected | None | ⊕ Very low |
| PHQ-9 | |||||||
| 2 (observational) | Serious limitationsa | No limitations | No limitations | Serious limitationsb | None detected | None | ⊕ Very low |
| Impact on Therapeutic Decisions | |||||||
| 1 (RCT) 3 (observational) | Serious limitationsa | Serious limitationsc | Very serious limitationsd | No limitations | None detected | None | ⊕ Very low |
| Patient Satisfaction | |||||||
| 1 (observational) | Serious limitationsa | No serious limitations | Very serious limitationse | No serious limitations | None detected | None | ⊕ Very low |
| Clinician Satisfaction | |||||||
| 1 (observational) | Serious limitationsa | No serious limitations | No serious limitations | No serious limitations | None detected | None | ⊕⊕ Low |
Abbreviations: GRADE, Grading of Recommendations Assessment, Development, and Evaluation; HAMD-17, 17-item Hamilton Rating Scale for Depression; PHQ-9, 9-item Patient Health Questionnaire; QIDS C16, 16-item Quick Inventory of Depressive Symptomatology, clinician rating; RCT, randomized controlled trial.
Risk of bias assessment details are available in Tables A2 and A3.
Wide confidence intervals impacted our confidence in the estimate of effect; experts advised that a clinically meaningful difference in HAMD-17 was two to three points.
Results were inconsistent between the studies: some demonstrated an increase in the mean number of medications per patient by end of study, and others a decrease.
Outcomes were indirect measures of the outcome of interest (the impact of guided therapy on therapeutic decision-making).
Measure of patient satisfaction was based on clinician perception of their patients' satisfaction.