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Table 1 Characteristics of included studies

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

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

  1. RCT randomized controlled trial, NL Netherlands, CD-ROM Compact Disc Read-Only Memory, No. number, DA decision aid, BRCA1 breast cancer gene 1, BRCA2 breast cancer gene 2, OC ovarian cancer, BC breast cancer, RR-BM risk-reducing bilateral mastectomy, RR-M risk-reducing mastectomy, RR-BO risk-reducing bilateral oophorectomy, RR-O risk-reducing oophorectomy, T2 4 weeks after blood sampling, T3 2 weeks after positive test result