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. Author manuscript; available in PMC: 2016 Jul 1.
Published in final edited form as: Genet Med. 2014 Dec 4;17(7):519–532. doi: 10.1038/gim.2014.140

Table 3.

Summary of findings table for MammaPrint

Quality assessment Summary of findings


Events (%) Anticipated absolute effects


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

Disease-free survival—5 years

0 (0) No
evidence
Low: NR NR
High: NR NR

Distant recurrence—10 years

0 (0) No
evidence
Low: NR NR
High: NR NR

Distant recurrence—5 years

0 (0) No
evidence
Low: NR NR
High: NR NR

Overall survival—10 years

0 (0) No
evidence
Low: NR NR
High: NR NR

Overall survival—5 years

0 (0) No
evidence
Low: NR NR
High: NR NR

Change in treatment decisions

563 (2
studies)
Undetected No serious
inconsistency
Seriousa,b No serious
imprecision
Undetected Low Not estimable Not estimable Not estimable Not estimable

Economic evaluation

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.

a

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.

b

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.

c

Inconsistency in the comparator used to estimate the ICER for MammaPrint.

d

Imprecision in estimates of treatment effects across risk groups determined by MammaPrint add to variability to the economic impact.