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

From: Effectiveness of decision aids for female BRCA1 and BRCA2 mutation carriers: a systematic review

Outcomes Instruments used for assessment RCT using the instrument a) Score (S.D.) or [range] b) Regression analysis p-value Main results
Decision related outcomes
 Decisional conflict Decisional Conflict Scalea Schwartz 2009 [23] b) Intervention, subjects were undecided at randomization: B − 0.35, z − 3.6 <  0.001 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 0.33
Metcalfe 2017 [25] a) 3 month: Intervention 25.6 (13.2), Control 26.8 (12.6) 0.59 No significant effect.
a) 6 month: Intervention 24.8 (13.8), Control 24.7 (12.8) 0.96
a) 12 month: Intervention 21.5 (13.7), Control 21.0 (12.3) 0.81
 Satisfaction with decision Variation of Decisional Conflict Scale/Satisfaction With Decision Scalec Armstrong 2005 [22] a) Intervention 31.2, Control 26.2 0.04 Significantly higher decision satisfaction in the DA group.
Satisfaction With Decision Scalea Schwartz 2009 [23] b) Intervention, subjects were undecided at randomization: B 0.27, z 3.1 0.002 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 0.48  
 Strenght of treatment preference 15-point scalec Metcalfe 2017 [25] a) Subjects reporting „undecided "(score 6–10):   No significant effect.
RR-M:   
3 month: Intervention 19, Control 15 0.52  
6 month: Intervention 12, Control 15 0.47  
12 month: Intervention 10, Control 15 0.81  
RR-O:   
3 month: Intervention 8, Control 2 0.05  
6 month: Intervention 4, Control 7 0.33  
12 month: Intervention 6, Control 7 0.66  
Tamoxifen:   
3 month: Intervention 15, Control 15 0.89  
6 month: Intervention 10, Control 12 0.57  
12 month: Intervention 10, Control 6 0.35  
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 <  0.001 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 0.17  
Hooker 2011 [24] No data are presented.   No data are presented.
Information related outcomes
 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) 0.98 No significant effect.
6 month: Intervention 90.1 (10.4), Control 89.7 (12.4) 0.55  
12 month: Intervention 92.0 (10.3), Control 91.6 (10.2) 0.84  
OC risk, mutation carriersd Armstrong 2005 [22] a) Intervention 54.0 [0–90)], Control 42.3 [0–80)] 0.54 No significant effect.
BC, risk after RR-M, mutation carriersd Armstrong 2005 [22] a) Intervention 15.0 [0–25)], Control 10.3 [0–50] 0.56 No significant effect.
BC, risk after RR-O, mutation carriersd Armstrong 2005 [22] a) Intervention 40.3 [0–80], Control 23.3 [0–80] 0.20 No significant effect.
BC, risk with Tamoxifen, mutation carriersd Armstrong 2005 [22] a) Intervention 11.2 [0–60], Control 9.2 [0–40] 0.26 No significant effect.
BC, risk with HRT after menopause, mutation carriersd Armstrong 2005 [22] a) Intervention 49.5 [0–90], Control 18.8 [0–45] 0.13 No significant effect.
BC, risk with Raloxifene after menopause, mutation carriersd Armstrong 2005 [22] a) Intervention 42.5 [0–75], Control 12.5 [0–30] 0.08 No significant effect.
BC, risk with mammography, mutation carriersd Armstrong 2005 [22] a) Intervention 63.8 [0–90], Control 41.7 [0–80] 0.12 No significant effect.
OC, risk after RR-O, mutation carriersd Armstrong 2005 [22] a) Intervention 6.7 [0–60], Control 6.5 [0–50] 0.65 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 0.33 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 0.06
b) 1–6 month, subjects obtaining RR-M: Intervention 8, Control 7, χ2 (df = 1, N = 209) = 0.44 0.51
b) 6–12 month, subjects obtaining RR-M: Intervention 10, Control 3, χ2 (df = 1, N = 194) = 3.80 0.05
Hooker 2011 [24] No data are presented.   No data are presented.
Health outcomes
 Anxiety Hopkins Symptom Checklist 25a Armstrong 2005 [22] Adjusted mean difference − 2.89e 0.45 No significant effect.
Revised Impact of Event Scale, intrusion subscaleb Armstrong 2005 [22] Adjusted mean difference 0.16e 0.89 No significant effect.
 Distress Impact of Event Scalea Hooker 2011 [24] b) 0–1 month: B 3.95, z 2.61 0.01 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 0.02
b) 6–12 month: B − 1.05, z − 0.67 0.51
Metcalfe 2017 [25] a) 3 month: Intervention 24.6 (13.9), Control 26.8 (12.8) 0.33 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) 0.01
a) 12 month: Intervention 17.7 (14.7), Control 22.4 (15.5) 0.05
Multidimensional Impact of Cancer Risk Assessment Questionnaireb Hooker 2011 [24] b) 0–1 month: B 3.08, z 2.01 0.04 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 0.28
b) 6–12 month: B − 0.32, z − 0.25 0.80
Brief Symptom Inventory, modified scalec Hooker 2011 [24] b) B − 0.46, z − 0.54 0.59 No significant effect.
  1. RCT randomized controlled trial, DA decision aid, OC ovarian cancer, BC breast cancer, RR-M risk-reducing mastectomy, RR-O risk-reducing oophorectomy, HRT hormone replacement therapy
  2. aInstrument was validated in a study
  3. bunclear, if instrument was validated
  4. cinstrument was not validated
  5. drisk estimates from 0 to 100%
  6. eUnclear comparison: The time points and groups are not specified