Background
Methods
Literature search
Inclusion and exclusion criteria
Paper coding
Quality of included studies
Data extraction and management
RCT - Parallel group | Author | Year of publication | Country | Time of recruitment | Inclusion criteria | No. of subjects randomized | Control: Comparator | Control: No. of subjects | Intervention | Intervention: No. of subjects |
Individualized survival curves improve satisfaction with cancer risk management decisions in women with BRCA1/2 mutations [22] | Armstrong | 2005 | USA | 2000–2003 | BRCA1- and BRCA2-positive women, with or without BC (no OC, no BC with metastases, no RR-BM + RR-BO) | 32 | Educational booklet | 13 | Educational booklet + binder with comprehension exercise, individualized survival curves and individualized BC incidence curves | 14 |
Randomized trial of a decision aid for BRCA1/BRCA2 mutation carriers: impact on measures of decision making and satisfaction [23] | Schwartz | 2009 | USA | 2001–2005 | BRCA1- and BRCA2-positive women, with or without BC/OC (no BC with metastases, no OC with metastases, no RR-BM) | 214 | Usual care | 114 | Usual care + interactive CD-ROM with information about BC and risk management options, tailored BC and OC risk graphs and an interactive decision task | 100 |
Longitudinal changes in patient distress following interactive decision aid use among BRCA1/2 carriers: a randomized trial [24] | Hooker | 2011 | USA | 2001–2005 | BRCA1- and BRCA2-positive women, with or without BC/OC (no BC with metastases, no OC with metastases, no RR-BM) | 214 | Usual care | 114 | Usual care + interactive CD-ROM with information about BC and risk management options, tailored breast and ovarian cancer risk graphs and an interactive decision task | 100 |
Effect of decision aid for breast cancer prevention on decisional conflict in women with a BRCA1 or BRCA2 mutation: a multisite, randomized, controlled trial [25] | Metcalfe | 2017 | Canada | 2008–2011 | BRCA1- and BRCA2-positive women, without cancer (no RR-M, no RR-O, no tamoxifen) | 150 | Usual care | 74 | Usual care + booklet with information about BC risks, BC preventive options, guidelines, studies and a possibility to compare the options | 76 |
RCT - Cross-over trial | Author | Year of publication | Country | Time of recruitement | Inclusion criteria | No. of subjects randomized | Control: Comparator | Group 1: No. of subjects | Intervention | Group 2: No. of subjects |
Randomised trial of a decision aid and its timing for women being tested for a BRCA1/2 mutation [26] | Van Roosmalen | 2004 | NL | 1999–2001 | BRCA1- and BRCA2-positive women, with or without BC/OC (no distant metastases, no RR-BM + RR-BO; no chemotherapy, radiotherapy or BC/OC surgery 1 month before blood sampling) | 384 | Usual care | T2 (before gen. Testing, gets DA): 184 T3 (positive test result): 47 | Usual care + Brochure with information about treatment options + 45 min. Video with interviews mutation carriers | T2 (before gen. Testing, gets no DA): 184 T3 (positive test result, gets DA): 42 |
One-Group Pretest-Posttest Design | Author | Year of publication | Country | Time of recruitement | Inclusion criteria | No. of subjects willing to participate | Subjects completing the pre-test questionnaire | Intervention | Subjects completing the post-test questionnaire | |
Development and testing of a decision aid for breast cancer prevention for women with a BRCA1 or BRCA2 mutation [27] | Metcalfe | 2007 | Canada | Not specified | BRCA1- and BRCA2-positive women, without BC/OC | 21 | 21 | Brochure with information about options and outcomes, risks and benefits, a valuing exercise and suggestions for follow-up discussions with their practitioner | 20 |
Results
Search results
Quality of included studies
Publication | Armstrong (2005) [22] | Schwartz (2009) [23] | Hooker (2011) [24] | Metcalfe (2017) [25] |
---|---|---|---|---|
Criterion | ||||
Adequate sequence generation | + | + | + | + |
Adequate allocation concealment | + | ? | ? | ? |
Blinding of participants and personnel | (−)b | (−)c | (−)c | – |
Blinding of outcome assessors | + | -a | -a | -a, d |
No incomplete outcome data | ? | ? | ? | ? |
No selective outcome reporting | + | + | + | + |
No other sources of bias | + | + | + | + |
RISK OF BIAS | Unclear | High | High | High |
Effects of the decision aids
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. |
Outcomes | Instruments used for assessment | Pretest-posttest study using the instrument | Score (S.D.) | p-value | Main results |
---|---|---|---|---|---|
Decision related outcomes | |||||
Decisional conflict | Decisional Conflict Scalea | Metcalfe 2007 [27] | Pre-test 36.2 (16.4), Post-test 23.0 (15.2) | 0.001 | Significantly less decisional conflict after using the DA. |
Strenght of treatment preference | 15-point scale | Metcalfe 2007 [27] | RR-M: | Significantly fewer women in the DA group were uncertain about RR-M and RR-O. | |
Pre-test No 14, Yes 3, Unsure 3 | |||||
Post-test No 10, Yes 4, Unsure 6 | 0.009 | ||||
RR-O: | |||||
Pre-test No 5, Yes 12, Unsure 3 | |||||
Post-test No 2, Yes 15, Unsure 3 | 0.003 | ||||
Tamoxifen: | |||||
Pre-test No 10, Yes 1, Unsure 9 | |||||
Post-test No 11, Yes 5, Unsure 4 | 0.12 | ||||
Information related outcomes | |||||
Risk perception | BC risk, mutation carriersb | Metcalfe 2007 [27] | Pre-test 65.1 (16.1), Post-test 73.6 (13.4) | 0.05 | Significantly better risk perception after using the DA. |
BC, risk after RR-M, mutation carriersb | Metcalfe 2007 [27] | Pre-test 71.8 (22.0), Post-test 84.2 (18.2) | 0.005 | Significantly better risk perception after using the DA. | |
BC, risk after RR-O, mutation carriersb | Metcalfe 2007 [27] | Pre-test 43.2 (20.0), Post-test 65.0 (13.3) | 0.001 | Significantly better risk perception after using the DA. | |
BC, risk with Tamoxifen, mutation carriersb | Metcalfe 2007 [27] | Pre-test 50.0 (19.0), Post-test 56.6 (10.0) | 0.17 | No significant difference. | |
BC, risk with mammography, mutation carriersb | Metcalfe 2007 [27] | Pre-test 21.5 (28.0), Post-test 13.5 (22.8) | 0.11 | No significant difference. | |
Health outcomes | |||||
Distress | Impact of Event Scalea | Metcalfe 2007 [27] | Pre-test 22.7 (13.7), Post-test 19.9 (14.5) | 0.24 | No significant difference. |