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Table 3 Methodological descriptions of the studies (N = 9)

From: Reasons for and against participation in studies of medicinal therapies for women with breast cancer: a debate

Reference Country Objective/Question Design Method Participants Data analysis
Altschuler & Somkin 2005 [19] USA Why did women who initially showed interest in participating in the STAR trial make different decisions about whether to participate or not participate? (tamoxifen or raloxifene) Qualitative chemo-prevention study Half-structured deep interviews 51 post-menopausal women with high breast cancer risk(28 participants and 23 non-participants) Grounded theory
Ellis et al 2002 [11] Canada Evaluation of information brochure, regarding theoretical willingness to participate in a 6-month clinical trial for breast cancer treatment (Tamoxifen alone, chemotherapy alone or combined) Quantitative before-after-study Questionnaires closed answers Before: 83 women with early invasive breast cancer
After: 67 women
Descriptive statistics
Houlihan et al 2010 [12] USA Investigation of factors influencing women's decision to participate in breast cancer prevention trial (tamoxifen, raloxifene). Quantitative case-control study Questionnaires through mail Of 242 post-menopausal women, 81 participated Logistic regression model
Kim et al 2004 [13] USA When financial conflicts of interest were stated on consent forms, which respondents refused to participate in a study using a new medication solely on the basis of these conflicts of interest? Quantitative study Internet questionnaires; closed answers 1006 female breast cancer patients Descriptive statistics
Lemieux et al 2008 [14] Canada Identifying barriers in the study protocols, with respect to the low recruitment rates in clinical breast cancer trials, 1997-2002. Quantitative study Questionnaires; closed answers 616 women participated in studies of Phase III (or II+ III) and 72 in studies of Phase II (or I+II). Multivariate analysis
Loehberg et al 2010 [15] Germany Identification of characteristics of women who wanted to receive information about a Phase II chemoprevention study. Quantitative, multi-centered study Questionnaires 202 women of 446 wanted to receive further information about the risk of breast cancer; 3 women decided to participate. Descriptive statistics
Mancini et al 2007 [16] France Identification of preferences in decision-making processes in relation to participation in another clinical drug trial. Quantitative, prospective cohort study Questionnaires Of 455 women 267 were invited to the study; of these 201 agreed to participate and 66 declined. Descriptive statistics and multivariate analysis
Mandelblatt et al 2005 [17] USA Effectiveness of a brief consultation and an informational brochure compared with use of brochure only in recruitment for a breast cancer prevention study. (tamoxifen and raloxifene) Quantitative, simple randomized controlled study Questionnaires 232 of 450 women participated in consultation +brochure-group; 218 of 450 in the brochure-only-group Descriptive statistics and logistical regression model
Rondanina et al 2008 [18] Italy Socio-demographic, health-related and psychological factors influencing decision to participate or not in a five-year hormone replacement therapy. (HRT-Phase III, low-dose tamoxifen) Quantitative study Questionnaires through mail 496 of 1457 women participated in the HET-study Descriptive statistics and multivariate analysis