Effects of different information brochures on women’s decision-making regarding mammography screening: study protocol for a randomized controlled questionnaire study

Abstract

BackgroundIn order to give informed consent for mammography screening, women need to be told the relevant facts; however, screening information often remains vague because of the worry that detailed information might deter women from participating in recommended screening programs. Since September 2010, German women aged 50 to 69 invited for mammography screening have received a new, comprehensive information brochure that frankly discusses the potential benefit and harm of mammography screening. In contrast, the brochure that was in use before September 2010 contained little relevant information.The aim of this study is to compare the impact of the two different brochures on the intention of women to undergo mammography screening, and to broaden our understanding of the effect that factual information has on the women’s decision-making.MethodsThis is a controlled questionnaire study comparing knowledge, views and hypothetical preferences of women aged 48–49 years after receiving the old versus the new information brochure. German GP’s in the region of North Rhine-Westfalia will be asked by mail and telephone to participate in the study. Eligible women will be recruited via their general practitioners (GPs) and randomized to groups A ('new brochure’) and B ('old brochure’), with an intended recruitment of 173 participants per group. The study is powered to detect a 15% higher or lower intention to undergo mammography screening in women informed by the new brochure.DiscussionThis study will contribute to our understanding of the decision-making of women invited to mammography screening. From both ethical and public health perspectives, it is important to know whether frank, factual information leads to a change in the intention of women to participate in a recommended breast cancer screening program.Trial registrationDRKS00004271

Assessment of the effects of decision aids about breast cancer screening: a systematic review and meta-analysis

“…The Eden et al study 25 assessed the postintervention intraindividual changes after the DA was provided. In the Gummersbach et al study, 27 a more informative leaflet was compared with a less informative one. Finally, in the Hersch et al study, 11 the intervention DA had evidence-based explanatory and quantitative information on overdiagnosis, BC mortality reduction and false positives, whereas the control DA included information on BC mortality reduction and false positives.…”

Does a decision aid improve informed choice in mammography screening? Results from a randomised controlled trial

“…Our DA was systematically developed and evidence based. The brochure that was in use during our study and was thus the usual care, had been in use since September 2010 and openly discussed benefits and harms of the MSP [ 40 ]. Only some but not all statistics were presented in absolute numbers [ 41 ].…”

Willingness to Participate in Mammography Screening

“…In a randomized controlled study, we compared the leaflet used up to 2010 with the one used from 2010 onward with respect to the recipients' willingness to undergo mammography screening and their knowledge about it (22).…”

“…Five items directly measured the participants' "objective knowledge" of the material benefits and risks of mammography screening (i.e., those that are relevant to decision-making), on a scale of 0 to 10 (eTable 1) (20,(22)(23)(24).…”