Background: Screening guidelines for women at familial risk of breast cancer without a known causative gene mutation differ internationally. To our knowledge, no randomised controlled MRI-screening trial has been performed. The FaMRIsc-study aims to assess the efficacy of MRI versus mammography screening for familial risk and furthermore assesses the influence of breast density. Methods: In 12 Dutch hospitals, 1355 women aged 30-55 years with a cumulative lifetime risk of ≥20% without a BRCA1/2 mutation were randomised with a web-based computer generated hospital sequence, concealed for participants, physicians and researchers, in either the MRI-group with yearly MRI, clinical breast examination and mammography biennially, or the Mammography-group with yearly mammography and clinical breast examination. Breastfeeding, pregnancy, previous screening and previous ductal carcinoma in situ were permitted, but no previous invasive cancer. Primary outcomes were number, size and nodal-stage of breast cancers. Secondary outcomes were sensitivity, specificity and positive predictive value. Results were also stratified by mammographic density (BI-RADS AD). Intention to screen analyses were performed. This trial was registered with the Netherlands Trial Register, NTR2789. Findings: Between Jan 1 2011, and Dec 31 2017 in the MRI-group (674 women) compared to the Mammographygroup (680 women) with a median follow-up of 5.2 years for both groups, more breast cancers were detected (40 versus 15, p<0•001), invasive cancers were smaller (median size 9 versus 17 mm, p=0•010) and less frequently node positive (4/24, 17% versus 5/8, 63%, p=0•023). In the MRI-group, specificity was significantly lower compared to the Mammography-group (83•8% versus 91•0%, p<0•001), while sensitivity hardly differed (97•5% versus 86.7%, p=0.18). Clinical breast examination contributed hardly to detection (1/55). In incident cancers, tumour stage was better in the MRI-group (p=0•035), with lower numbers of node positive and ≥T2 tumours, while specificity improved in both arms (MRI-group: 87•4%, Mammography-group: 92•6%, p<0•001). All tumours ≥T2 were in the two highest density categories. In BI-RADS density A-C MRI was most effective. Interpretation: The earlier detection by MRI screening and especially the fewer late-stage cancers in incident rounds, may reduce adjuvant chemotherapy and mortality. However, especially for women with the highest breast density at the cost of more false positive results.
PurposeDecision aids (DAs) support patients in shared decision-making by providing balanced evidence-based treatment information and eliciting patients’ preferences. The purpose of this systematic review was to assess the quality and communicative aspects of DAs for women diagnosed with early-stage breast cancer.MethodsTwenty-one currently available patient DAs were identified through both published literature (MEDLINE, Embase, CINAHL, CENTRAL, and PsycINFO) and online sources. The DAs were reviewed for their quality by using the International Patient Decision Aid Standards (IPDAS) checklist, and subsequently assessed to what extent they paid attention to various communicative aspects, including (i) information presentation, (ii) personalization, (iii) interaction, (iv) information control, (v) accessibility, (vi) suitability, and (vii) source of information.ResultsThe quality of the DAs varied substantially, with many failing to comply with all components of the IPDAS criteria (mean IPDAS score = 64%, range 31–92%). Five aids (24%) did not include any probability information, 10 (48%) presented multimodal descriptions of outcome probabilities (combining words, numbers, and visual aids), and only 2 (10%) provided personalized treatment outcomes based on patients and tumor characteristics. About half (12; 57%) used interaction methods for eliciting patients’ preferences, 16 (76%) were too lengthy, and 5 (24%) were not fully accessible.ConclusionsIn addition to the limited adherence to the IPDAS checklist, our findings suggest that communicative aspects receive even less attention. Future patient DA developments for breast cancer treatment should include communicative aspects that could influence the uptake of DAs in daily clinical practice.Electronic supplementary materialThe online version of this article (10.1007/s10549-019-05351-4) contains supplementary material, which is available to authorized users.
The Dutch-translated BIS showed excellent psychometric results very similar to the original BIS. Its concise and simple design further supports wide application in clinical practice.
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