Table 9:
GRADE Evidence Profile for Clinical Utility of Prolaris Cell Cycle Progression Test
| Number of Studies (Design) | Risk of Bias | Inconsistency | Indirectness | Imprecision | Publication Bias | Upgrade Considerations | Quality |
|---|---|---|---|---|---|---|---|
| Change in planned treatment | |||||||
| 1 (observationala,b) | Serious limitations (−1)c | No serious limitations | No serious limitations | No serious limitations | Undetected | NA | ⊕ Very low |
| Change in actual treatment | |||||||
| 1 (observationala,b) | No serious limitations | No serious limitations | Serious limitations (−1)d | No serious limitations | Undetected | NA | ⊕ Very low |
Abbreviations: NA, not applicable.
a
Evidence for this outcome begins at low quality as it is comprised of observational studies.
b
Change in treatment is a surrogate for patient-important outcomes as it remains unknown how or if change in treatment influences patient-important outcomes.
c
Very few of the best practices for reducing bias in this study design were reported in the article. See Appendix 2, Table A1, for full risk of bias assessment.
d
In Canada, treatment options and combinations differ from those studied, and treatment patterns are much more conservative overall, especially for low-risk patients.