Table 3.
Outcomes, instruments used, and effects of decisions aids evaluated in the included RCT
| 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. | |
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
aInstrument was validated in a study
bunclear, if instrument was validated
cinstrument was not validated
drisk estimates from 0 to 100%
eUnclear comparison: The time points and groups are not specified