Result card

  • SOC7: What are the consequences in decision making?
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What are the consequences in decision making?

Authors: Pseudo85 Pseudo85, Pseudo84 Pseudo84

Internal reviewers: Eva Kernstock, Alessandra Lo Scalzo, Alexandra Sauer

The domain methodology was used for this question (analysis of selected studies extracted from the basic literature search).

Oncotype DX

Genomic tests can help to inform treatment decisions, but a challenge is how best to communicate and incorporate test results when patients make complex decisions about adjuvant treatment for cancer. As shown in various studies most of the women preferred having an active or shared role in medical decisions. {5}, {11}

Lillie et al. (2008) investigated the effect of health literacy on desire for active participation in two decisions: the decision to have the recurrence risk test and the decision to use the test results to inform decisions about which adjuvants should be used after surgery. Interviews of 167 patients (recruited only post-surgery and post-treatment who either did not receive neoadjuvant or adjuvant chemotherapy or had completed it) showed that the women’s desires to be actively involved in both the decision to have the recurrence risk test done and in treatment decisions based on test results differed according to their health literacy levels. Women with higher health literacy indicated a preference for more active participation in the decision to have the recurrence risk test than did women with lower health literacy. This finding was statistically significant (P = 0.03). Similarly, women with higher health literacy more often indicated that they preferred active participation in the decision to use the results of the recurrence risk test to make treatment decisions than did women with lower health literacy (P<0.001). Women with lower health literacy reported an interest in passive decision making (34%) that those with higher health literacy did not have (6%). They showed there is a larger effect of health literacy on decision-making preferences for use of the recurrence risk test results to inform care than for being tested in the first place. Experiences with Oncotype DX and beliefs about the test are also potentially important because they can reduce breast cancer patients’ willingness to let the results guide treatment decisions. {5}

The results of the multicentre trial by Lo et al. confirm that the RS assay impacts patient treatment choice. The trial consecutively enrolled 89 women with lymph node-negative, oestrogen-positive breast cancer who were medically fit to receive adjuvant chemotherapy. Several authors declared financial ties to Genomic Health and the trial received direct funding from Genomic Health. Patients’ treatment decisions before and after Oncotype-DX testing were recorded and the results showed a change for 24 women (27%). Patients usually experience reduced anxiety over their treatment decision, greater satisfaction, and increased confidence in their choice of therapy. They reported significantly lower conflict about the decision for adjuvant treatment  after the RS assay and had significantly decreased situational anxiety immediately after learning the results of the RS assay, which remained stable at 12 months. The perceived risk of recurrence was an important factor in women’s choice of treatment. On a scale of 0 to 100, with 100 indicating definite recurrence, patients ‘mean estimated risk before the RS assay was 22.4 and after the assay was 16.0 (P = 0.001). Patients’ estimated risk of recurrence post-RS was significantly correlated with their RS assay result (r = 0.42; P = 0.001) and significantly lower immediately after the RS assay, but lost significance at 12 months. {6}

The literature contains little information on the consequences of using prognostic tests in decision making. There are no studies that address this question for the MammaPrint and uPA/PAI-1tests.

Pseudo85 P, Pseudo84 P Result Card SOC7 In: Pseudo85 P, Pseudo84 P Social aspects In: Jefferson T, Vicari N, Raatz H [eds.]. Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX ) [Core HTA], Agenzia nationale per i servizi sanitari regionali (, Italy ; 2013. [cited 2 December 2022]. Available from: