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Background With the aim of increasing benefits and decreasing harms, risk-based breast cancer screening has been proposed as an alternative to age-based screening. This study explores barriers and facilitators to implementing a risk-based breast cancer screening program from the perspective of health professionals, in the context of a National Health Service. Methods Socio-constructivist qualitative research carried out in Catalonia (Spain), in the year 2019. Four discussion groups were conducted, with a total of 29 health professionals from primary care, breast cancer screening programs, hospital breast units, epidemiology units, and clinical specialties. A descriptive-interpretive thematic analysis was performed. Results Identified barriers included resistance to reducing the number of screening exams for low-risk women; resistance to change for health professionals; difficulties in risk communication; lack of conclusive evidence of the benefits of risk-based screening; limited economic resources; and organizational transformation. Facilitators include benefits of risk-based strategies for high and low-risk women; women's active role in their health care; proximity of women and primary care professionals; experience of health professionals in other screening programs; and greater efficiency of a risk-based screening program. Organizational and administrative changes in the health system, commitment by policy makers, training of health professionals, and educational interventions addressed to the general population will be required. Conclusions Despite the expressed difficulties, participants supported the implementation of risk-based screening. They highlighted its benefits, especially for women at high risk of breast cancer and those under 50 years of age, and assumed a greater efficiency of the risk-based program compared to the aged-based one. Future studies should assess the efficiency and feasibility of risk-based breast cancer screening for its transfer to clinical practice. DDEUIT

BACKGROUND: In Spain, women invited to breast screening are not usually informed about potential harms of screening. The objective of the InforMa study is to assess the effect of receiving information about the benefits and harms of breast screening on informed choice and other decision-making outcomes, in women approaching the age of invitation to mammography screening. METHODS: Two-stage randomised controlled trial. In the first stage, 40 elementary territorial units of the public healthcare system were selected and randomised to intervention or control. In the second stage, women aged 49-50 years were randomly selected. The target sample size was 400 women. Women in the intervention arm received a decision aid (DA) with detailed information on the benefits and harms of screening. Women in the control arm received a standard leaflet that did not mention harms and recommended accepting the invitation to participate in the Breast Cancer Screening Program (BCSP). The primary outcome was informed choice, defined as adequate knowledge and intentions consistent with attitudes. Secondary outcomes included decisional conflict, worry about breast cancer, time perspective, opinions about the DA or the leaflet, and participation in the BCSP. RESULTS: In the intervention group, 23.2% of 203 women made an informed choice compared to only 0.5% of 197 women in the control group (p < 0.001). Attitudes and intentions were similar in both study groups with a high frequency of women intending to be screened, 82.8% vs 82.2% (p = 0.893). Decisional conflict was significantly lower in the intervention group. No differences were observed in confidence in the decision, anxiety, and participation in BCSP. CONCLUSIONS: Women in Spain lack knowledge on the benefits and harms of breast screening. Providing quantitative information on benefits and harms has produced a considerable increase in knowledge and informed choice, with a high acceptance of the informative materials. TRIAL REGISTRATION: Trial identifier NCT03046004 at ClinicalTrials.gov registry. Registered on February 4 2017. Trial name: InforMa study. This study was supported by the research grant “Women participation in decisions and strategies on early detection of breast cancer” (PI14/00113) from the Instituto de Salud Carlos III and cofunded by Fondo Europeo de Desarrollo Regional (FEDER) “Una manera de hacer Europa.” Anna Pons received a grant for PhD students from the Lleida Biomedical Research Institute (IRBLleida). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

This qualitative study evaluates a decision aid that includes the benefits and harms of breast cancer screening and analyses women's perception of the information received and healthcare professionals' perceptions of the convenience of providing it. Seven focus groups of women aged 40-69 years (n = 39) and two groups of healthcare professionals (n = 23) were conducted in Catalonia and the Canary Islands. The focus groups consisted of guided discussions regarding decision-making about breast cancer screening, and acceptability and feasibility of the decision aid. A content analysis was performed. Women positively value receiving information regarding the benefits and harms of breast cancer screening. Several women had difficulties understanding some concepts, especially those regarding overdiagnosis. Women preferred to share the decisions on screening with healthcare professionals. The professionals noted the lack of inclusion of some harms and benefits in the decision aid, and proposed improving the clarity of the statistical information. The information on overdiagnosis generates confusion among women and controversy among professionals. Faced with the new information presented by the decision aid, the majority of women prefer shared decision-making; however, its feasibility might be limited by a lack of knowledge and attitudes of rejection from healthcare professionals. Research Funding Instituto de Salud Carlos III Fondo Europeo de Desarrollo Regional (FEDER) DDEUIT

Background The decision to participate or not in breast cancer screening is complex due to the trade-off between the expected benefit of breast cancer mortality reduction and the major harm of overdiagnosis. It seems ethically necessary to inform women so that they can actively participate in decision-making and make an informed choice based on their values and preferences. The objective of this study is to assess the effects of receiving information about the benefits and harms of screening on decision-making, in women approaching the age of invitation to mammography screening. Methods A two-stage, randomized controlled trial (RCT). In the first stage, 40 Basic Health Areas (BHAs) will be selected and randomized to intervention or control. In the second stage, women within each BHA will be randomly selected (n = 400). Four breast cancer screening programs (BCSPs) of the Spanish public health system, three in Catalonia and one in the Canary Islands will participate in the study. Women in the intervention arm will receive a leaflet with detailed information on the benefits and harms of screening using mammography. Women in the control arm will receive a standard leaflet that does not mention harms and recommends accepting the invitation to participate in the biennial examinations of the BCSP. The primary outcome is informed choice, a dichotomous variable that combines knowledge, attitudes, and intentions. Secondary outcomes include decisional conflict; confidence in the decision made; anxiety about screening participation; worry about breast cancer; anticipated regret; time perspective; perceived importance of benefits/harms of screening; perceived risk of breast cancer; and leaflet acceptability. Primary and secondary outcomes are assessed 2–3 weeks after the intervention. Discussion This is the first RCT that assesses the effect of informing about the benefits and harms of breast cancer screening in Spain in women facing the decision to be screened using mammography. It aims to assess the impact of information on several decisional outcomes and to contribute to paving the road towards shared decision-making in breast cancer screening in our country. Trial registration ClinicalTrials.gov registry, ID: NCT03046004. Retrospectively registered on 4 February 2017. Trial name: InforMa study. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2161-7) contains supplementary material, which is available to authorized users.

Pre-intervention questionnaire (Q1). Baseline characteristics of participants. (PDF 253 kb)

Background The decision to participate or not in breast cancer screening is complex due to the trade-off between the expected benefit of breast cancer mortality reduction and the major harm of overdiagnosis. It seems ethically necessary to inform women so that they can actively participate in decision-making and make an informed choice based on their values and preferences. The objective of this study is to assess the effects of receiving information about the benefits and harms of screening on decision-making, in women approaching the age of invitation to mammography screening. Methods A two-stage, randomized controlled trial (RCT). In the first stage, 40 Basic Health Areas (BHAs) will be selected and randomized to intervention or control. In the second stage, women within each BHA will be randomly selected (n = 400). Four breast cancer screening programs (BCSPs) of the Spanish public health system, three in Catalonia and one in the Canary Islands will participate in the study. Women in the intervention arm will receive a leaflet with detailed information on the benefits and harms of screening using mammography. Women in the control arm will receive a standard leaflet that does not mention harms and recommends accepting the invitation to participate in the biennial examinations of the BCSP. The primary outcome is informed choice, a dichotomous variable that combines knowledge, attitudes, and intentions. Secondary outcomes include decisional conflict; confidence in the decision made; anxiety about screening participation; worry about breast cancer; anticipated regret; time perspective; perceived importance of benefits/harms of screening; perceived risk of breast cancer; and leaflet acceptability. Primary and secondary outcomes are assessed 2-3 weeks after the intervention. Discussion This is the first RCT that assesses the effect of informing about the benefits and harms of breast cancer screening in Spain in women facing the decision to be screened using mammography. It aims to assess the impact of information on several decisional outcomes and to contribute to paving the road towards shared decision-making in breast cancer screening in our country. Trial registration ClinicalTrials.gov registry, ID: NCT03046004. Retrospectively registered on 4 February 2017. Trial name: InforMa study. DDEUIT

SPIRIT Checklist. Checklist of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. (PDF 99 kb)

Post-intervention questionnaire (Q2). Study outcomes. (PDF 298 kb)

Study leaflet. Leaflet with detailed information on the benefits and harms of screening with mammography, used in the intervention arm of the study. (PDF 791 kb)

Objectives The usual practice in breast cancer screening programmes for mammogram interpretation is to perform double reading. However, little is known about its cost-effectiveness in the context of digital mammography. Our purpose was to evaluate the cost-effectiveness of double reading versus single reading of digital mammograms in a population-based breast cancer screening programme. Methods Data from 28,636 screened women was used to establish a decision-tree model and to compare three strategies: 1) double reading; 2) double reading for women in their first participation and single reading for women in their subsequent participations; and 3) single reading. We calculated the incremental cost-effectiveness ratio (ICER), which was defined as the expected cost per one additionally detected cancer. We performed a deterministic sensitivity analysis to test the robustness of the ICER. Results The detection rate of double reading (5.17 parts per thousand) was similar to that of single reading (4.78 parts per thousand; P = .768). The mean cost of each detected cancer was (sic)8,912 for double reading and (sic)8,287 for single reading. The ICER of double reading versus single reading was (sic)16,684. The sensitivity analysis showed variations in the ICER according to the sensitivity of reading strategies. The strategy that combines double reading in first participation with single reading in subsequent participations was ruled out due to extended dominance. Conclusions From our results, double reading appears not to be a cost-effective strategy in the context of digital mammography. Double reading would eventually be challenged in screening programmes, as single reading might entail important net savings without significantly changing the cancer detection rate. These results are not conclusive and should be confirmed in prospective studies that investigate long-term outcomes like quality adjusted life years (QALYs).