Table 3 Outcomes, instruments used, and effects of decisions aids evaluated in the included RCT

 Decisional conflict

Decisional Conflict Scale^a

Schwartz 2009 [23]

b) Intervention, subjects were undecided at randomization: B − 0.35, z − 3.6

Significant decreases in decisional conflict in initially undecided women in the DA group.

b) Intervention, subjects were decided at randomization: B − 0.10, z − 0.98

Metcalfe 2017 [25]

a) 3 month: Intervention 25.6 (13.2), Control 26.8 (12.6)

No significant effect.

a) 6 month: Intervention 24.8 (13.8), Control 24.7 (12.8)

a) 12 month: Intervention 21.5 (13.7), Control 21.0 (12.3)

 Satisfaction with decision

Variation of Decisional Conflict Scale/Satisfaction With Decision Scale^c

Armstrong 2005 [22]

a) Intervention 31.2, Control 26.2

Significantly higher decision satisfaction in the DA group.

Satisfaction With Decision Scale^a

Schwartz 2009 [23]

b) Intervention, subjects were undecided at randomization: B 0.27, z 3.1

Significant increase in satisfaction with decision in initially undecided women in the DA group.

b) Intervention, subjects were decided at randomization: B − 0.07, z − 0.7

 Strenght of treatment preference

15-point scale^c

Metcalfe 2017 [25]

a) Subjects reporting „undecided "(score 6–10):

No significant effect.

RR-M:

3 month: Intervention 19, Control 15

6 month: Intervention 12, Control 15

12 month: Intervention 10, Control 15

RR-O:

3 month: Intervention 8, Control 2

6 month: Intervention 4, Control 7

12 month: Intervention 6, Control 7

Tamoxifen:

3 month: Intervention 15, Control 15

6 month: Intervention 10, Control 12

12 month: Intervention 10, Control 6

Final decision vs. No final decision

Schwartz 2009 [23]

b) Intervention, subjects were undecided at randomization: OR 3.09, 95% CI 1.62, 5.90

Significantly increased likelihood to reach a management decision in initially undecided women in the DA group.

b) Intervention, subjects were decided at randomization: OR 0.56, 95% CI 0.24, 1.29

Hooker 2011 [24]

No data are presented.

No data are presented.

 Risk perception

Knowledge questionnaire (see also Metcalfe 2007)^c

Metcalfe 2017 [25]

a) 3 month: Intervention 89.9 (9.4), Control 89.9 (9.8)

No significant effect.

6 month: Intervention 90.1 (10.4), Control 89.7 (12.4)

12 month: Intervention 92.0 (10.3), Control 91.6 (10.2)

OC risk, mutation carriers^d

Armstrong 2005 [22]

a) Intervention 54.0 [0–90)], Control 42.3 [0–80)]

No significant effect.

BC, risk after RR-M, mutation carriers^d

Armstrong 2005 [22]

a) Intervention 15.0 [0–25)], Control 10.3 [0–50]

No significant effect.

BC, risk after RR-O, mutation carriers^d

Armstrong 2005 [22]

a) Intervention 40.3 [0–80], Control 23.3 [0–80]

No significant effect.

BC, risk with Tamoxifen, mutation carriers^d

Armstrong 2005 [22]

a) Intervention 11.2 [0–60], Control 9.2 [0–40]

No significant effect.

BC, risk with HRT after menopause, mutation carriers^d

Armstrong 2005 [22]

a) Intervention 49.5 [0–90], Control 18.8 [0–45]

No significant effect.

BC, risk with Raloxifene after menopause, mutation carriers^d

Armstrong 2005 [22]

a) Intervention 42.5 [0–75], Control 12.5 [0–30]

No significant effect.

BC, risk with mammography, mutation carriers^d

Armstrong 2005 [22]

a) Intervention 63.8 [0–90], Control 41.7 [0–80]

No significant effect.

OC, risk after RR-O, mutation carriers^d

Armstrong 2005 [22]

a) Intervention 6.7 [0–60], Control 6.5 [0–50]

No significant effect.

Actual treatment choice

RR-M vs. No RR-M

Schwartz 2009 [23]

b) 0–12 month, subjects obtaining RR-M: Intervention 18, Control 15, χ2 (df = 1, N = 214) = 0.96

No difference in DA or control group in having a RR-M or not, but impact of the DA in timing of the RR-M (control: early after testing; DA: 6–12 month after testing).

b) 0–1 month, subjects obtaining RR-M: Intervention 0, Control 5, 2-tailed Fisher Exact Test

b) 1–6 month, subjects obtaining RR-M: Intervention 8, Control 7, χ2 (df = 1, N = 209) = 0.44

b) 6–12 month, subjects obtaining RR-M: Intervention 10, Control 3, χ2 (df = 1, N = 194) = 3.80

Hooker 2011 [24]

No data are presented.

No data are presented.

 Anxiety

Hopkins Symptom Checklist 25^a

Armstrong 2005 [22]

Adjusted mean difference − 2.89^e

No significant effect.

Revised Impact of Event Scale, intrusion subscale^b

Armstrong 2005 [22]

Adjusted mean difference 0.16^e

No significant effect.

 Distress

Impact of Event Scale^a

Hooker 2011 [24]

b) 0–1 month: B 3.95, z 2.61

Women in the control group reported significantly decreased distress in the month following randomization compared to women in the DA group. From 1 to 6 months women in the DA group reported significantly reduced distress compared to women who received UC. From 6 to 12 months no significant differences between groups were found. By 12-months, the overall decrease in distress between the two groups was similar.

b) 1–6 month: B − 3.71, z − 2.35

b) 6–12 month: B − 1.05, z − 0.67

Metcalfe 2017 [25]

a) 3 month: Intervention 24.6 (13.9), Control 26.8 (12.8)

Women in the DA group showed significantly lower cancer related distress at 6 and 12 month post-randomization compared to the control group.

a) 6 month: Intervention 19.3 (13.2), Control 25.2 (14.5)

a) 12 month: Intervention 17.7 (14.7), Control 22.4 (15.5)

Multidimensional Impact of Cancer Risk Assessment Questionnaire^b

Hooker 2011 [24]

b) 0–1 month: B 3.08, z 2.01

At 1 month post-randomization women in the control group showed significantly decreased distress relative to the DA group. From 1 to 6 months and from 6 to 12 months, the groups did not differ significantly in their decrease of distress.

b) 1–6 month: B − 1.35, z − 1.08

b) 6–12 month: B − 0.32, z − 0.25

Brief Symptom Inventory, modified scale^c

Hooker 2011 [24]

b) B − 0.46, z − 0.54

No significant effect.