Table 1.

Characteristics of included studies

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

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