Table 3.
Quality assessment | Summary of findings | |||||||||||
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Events (%) | Anticipated absolute effects | |||||||||||
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Participants (studies) |
Risk of bias | Inconsistency | Indirectness | Imprecision | Publication bias |
Quality of evidence |
Risk | CHT | Non- CHT |
Relative effect (95% CI) |
Risk in controls (non-CHT) |
Risk difference (95% CI) |
Disease-free survival—10 years | ||||||||||||
| ||||||||||||
0 (0) | No evidence |
Low: | NR | NR | ||||||||
High: | NR | NR | ||||||||||
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Disease-free survival—5 years | ||||||||||||
| ||||||||||||
0 (0) | No evidence |
Low: | NR | NR | ||||||||
High: | NR | NR | ||||||||||
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Distant recurrence—10 years | ||||||||||||
| ||||||||||||
0 (0) | No evidence |
Low: | NR | NR | ||||||||
High: | NR | NR | ||||||||||
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Distant recurrence—5 years | ||||||||||||
| ||||||||||||
0 (0) | No evidence |
Low: | NR | NR | ||||||||
High: | NR | NR | ||||||||||
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Overall survival—10 years | ||||||||||||
| ||||||||||||
0 (0) | No evidence |
Low: | NR | NR | ||||||||
High: | NR | NR | ||||||||||
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Overall survival—5 years | ||||||||||||
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0 (0) | No evidence |
Low: | NR | NR | ||||||||
High: | NR | NR | ||||||||||
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Change in treatment decisions | ||||||||||||
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563 (2 studies) |
Undetected | No serious inconsistency |
Seriousa,b | No serious imprecision |
Undetected | Low | Not estimable | Not estimable | Not estimable | Not estimable | ||
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Economic evaluation | ||||||||||||
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Six studies | Undetected | Serious inconsistencyc |
No serious indirectness | Serious imprecisiond |
Undetected | Low | Not estimable | ICER/QALY gainedc: $716 to £53,058 |
Costs: €7,430 decrease to €1,130 increase |
QALYs gainedc: −0.21 to 1.20 |
CHT, chemotherapy; CI, confidence interval; ICER, incremental cost-effectiveness ratio; NR, not reported; QALY, quality-adjusted life year.
Indirectness in the overall study design which did not have a non-gene-expression profiling (GEP) test control group and did not make treatment decisions according to GEP test result.
Indirectness in the participant populations within and between studies as well as in criteria used to determine initial treatment compared to GEP-test based treatment decisions.
Inconsistency in the comparator used to estimate the ICER for MammaPrint.
Imprecision in estimates of treatment effects across risk groups determined by MammaPrint add to variability to the economic impact.