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The aim of this study was to assess the acceptability and feasibility of offering risk-based breast cancer screening and its integration into regular clinical practice. A single-arm proof-of-concept trial was conducted with a sample of 387 women aged 40-50 years residing in the city of Lleida (Spain). The study intervention consisted of breast cancer risk estimation, risk communication and screening recommendations, and a follow-up. A polygenic risk score with 83 single nucleotide polymorphisms was used to update the Breast Cancer Surveillance Consortium risk model and estimate the 5-year absolute risk of breast cancer. The women expressed a positive attitude towards varying the frequency of breast screening according to individual risk and, especially, more frequently inviting women at higher-than-average risk. A lower intensity screening for women at lower risk was not as welcome, although half of the participants would accept it. Knowledge of the benefits and harms of breast screening was low, especially with regard to false positives and overdiagnosis. The women expressed a high understanding of individual risk and screening recommendations. The participants' intention to participate in risk-based screening and satisfaction at 1-year were very high.

Breast cancer is the leading cause of death in the world among women. The Spanish National Health System (SNHS) introduced population-based breast cancer screening in 1990. As in most European programs, risk is identified on the basis of age and a mammogram is offered every two years to women aged 50-69 years. Scientific evidence is moving toward personalized screening, based on individual risk. This article presents the clinical trials that will evaluate the efficacy of personalized screening and some studies carried out in our environment on the effect of informing women of the benefits and adverse effects of screening or the acceptability and feasibility of offering personalized screening, in the Shared Decision Making context. The Preventive Activities and Health Promotion Program can help transform screening in our SNHS., (Copyright © 2022 The Author(s). Publicado por Elsevier España, S.L.U. All rights reserved.)

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., Competing Interests: The authors have declared that no competing interests exist.

Introduction: Personalised cancer screening aims to improve benefits, reduce harms and being more cost-effective than age-based screening. The objective of the DECIDO study is to assess the acceptability and feasibility of offering risk-based personalised breast cancer screening and its integration in regular clinical practice in a National Health System setting., Methods and Analysis: The study is designed as a single-arm proof-of-concept trial. The study sample will include 385 women aged 40-50 years resident in a primary care health area in Spain. The study intervention consists of (1) a baseline visit; (2) breast cancer risk estimation; (3) a second visit for risk communication and screening recommendations based on breast cancer risk and (4) a follow-up to obtain the study outcomes.A polygenic risk score (PRS) will be constructed as a composite likelihood ratio of 83 single nucleotide polymorphisms. The Breast Cancer Surveillance Consortium risk model, including age, race/ethnicity, family history of breast cancer, benign breast disease and breast density will be used to estimate a preliminary 5-year absolute risk of breast cancer. A Bayesian approach will be used to update this risk with the PRS value.The primary outcome measures will be attitude towards, intention to participate in and satisfaction with personalised breast cancer screening. Secondary outcomes will include the proportions of women who accept to participate and who complete the different phases of the study. The exact binomial and the Student's t-test will be used to obtain 95% CIs., Ethics and Dissemination: The study protocol was approved by the Drug Research Ethics Committee of the University Hospital Arnau de Vilanova. The trial will be conducted in compliance with this study protocol, the Declaration of Helsinki and Good Clinical Practice.The results will be published in peer-reviewed scientific journals and disseminated in scientific conferences and media., Trial Registration Number: NCT03791008., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Colorectal cancer (CRC) screening has proven effective in reducing CRC mortality. This study aimed to systematically review, and evaluate the reporting quality, of the economic evidence regarding CRC screening in average-risk individuals., Methods: Databases searched included Medline, EMBASE, National Health Service Economic Evaluation, Database of Abstracts of Reviews of Effects, Cost-Effectiveness Analysis registry, EconLit, and Health Technology Assessment database. Eligible studies were cost-effectiveness and cost-utility analyses comparing CRC screening strategies in average-risk individuals, published in English or Spanish, between January 2012 and November 2018. Reporting quality was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist., Results: Of 1,993 publications initially retrieved, 477 were excluded by duplicate review, 1,449 by title/abstract review, and 34 by full-text review. Finally, 33 publications were included in the qualitative synthesis. Most studies were conducted in Europe (36,4%), followed by United States (24,2%) and Asia (24,2%). The main screening modalities considered were fecal immunochemical tests (70%), colonoscopy (67%), guaiac fecal occult blood test (42%) and flexible sigmoidoscopy (30%). In most studies, CRC screening was deemed cost-effective compared to no screening. Sensitivity analyses indicated that cost of CRC screening tests, adherence to screening, screening test sensitivity, and cost of CRC treatment had the greatest impact on cost-effectiveness results across studies. The majority of studies (73%) adequately reported at least 50% of the items included in the CHEERS checklist. Least well reported items included setting, study perspective, discount rate, model choice, and methods to identify effectiveness data or to estimate resource use and costs., Conclusions: CRC screening is an efficient alternative to no screening. Nevertheless, it is not possible to conclude which strategy should be preferred for population-based screening programs. Although we observed an overall good adherence to CHEERS recommendations, there is still room for improvement in economic evaluations reporting in this field., Competing Interests: JM is a full-time employee of Shire International GmbH, a Takeda company. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Objective: The aim of this systematic review and meta-analysis of randomised controlled trials (RCTs) and observational studies is to assess the effect of decision aids (DAs) in women aged 50 and below facing the decision to be screened for breast cancer., Setting: Screening for breast cancer., Intervention: DAs aimed to help women make a deliberative choice regarding participation in mammography screening by providing information on the options and outcomes., Eligible Studies: We included published original, non-pilot, studies that assess the effect of DAs for breast cancer screening. We excluded the studies that evaluated only participation intention or actual uptake. The studies' risk of bias was assessed with the Cochrane Collaboration's tool for RCTs and the National Institutes of Health Quality Assessment Tool for non-RCTs., Primary and Secondary Outcomes: The main outcome measures were informed choice, decisional conflict and/or confidence, and knowledge. Secondary outcomes were values, attitudes, uncertainty and intention to be screened., Results: A total of 607 studies were identified, but only 3 RCTs and 1 before-after study were selected. The use of DAs increased the proportion of women making an informed decision by 14%, 95% CI (2% to 27%) and the proportion of women with adequate knowledge by 12%, 95% CI (7% to 16%). We observed heterogeneity among the studies in confidence in the decision. The meta-analysis of the RCTs showed a significant decrease in confidence in the decision and in intention to be screened., Conclusions: Tools to aid decision making in screening for breast cancer improve knowledge and promote informed decision; however, we found divergent results on decisional conflict and confidence in the decision. Under the current paradigm change, which favours informed choice rather than maximising uptake, more research is necessary for the improvement of DAs., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Personalized breast cancer screening is a novel strategy that estimates individual risk based on age, breast density, family history of breast cancer, personal history of benign breast lesions, and polygenic risk. Its goal is to propose personalized early detection recommendations for women in the target population based on their individual risk. Our aim was to synthesize the factors that influence women's decision to participate in personalized breast cancer screening, from the perspective of women and health care professionals. Methods: Systematic review of qualitative evidence on factors influencing participation in personalized Breast Cancer Screening. We searched in Medline, Web of science, Scopus, EMBASE, CINAHL and PsycINFO for qualitative and mixed methods studies published up to March 2022. Two reviewers conducted study selection and extracted main findings. We applied the best-fit framework synthesis and adopted the Multilevel influences on the cancer care continuum model for analysis. After organizing initial codes into the seven levels of the selected model, we followed thematic analysis and developed descriptive and analytical themes. We assessed the methodological quality with the Critical Appraisal Skills Program tool. Results: We identified 18 studies published between 2017 and 2022, conducted in developed countries. Nine studies were focused on women (n = 478) and in four studies women had participated in a personalized screening program. Nine studies focused in health care professionals (n = 162) and were conducted in primary care and breast cancer screening program settings. Factors influencing women's decision to participate relate to the women themselves, the type of program (personalized breast cancer screening) and perspective of health care professionals. Factors that determined women participation included persistent beliefs and insufficient knowledge about breast cancer and personalized screening, variable psychological reactions, and negative attitudes towards breast cancer risk estimates. Other factors against participation were insufficient health care professionals knowledge on genetics related to breast cancer and personalized screening process. The factors that were favourable included the women's perceived benefits for themselves and the positive impact on health systems. Conclusion: We identified the main factors influencing women's decisions to participate in personalized breast cancer screening. Factors related to women, were the most relevant negative factors. A future implementation requires improving health literacy for women and health care professionals, as well as raising awareness of the strategy in society. [ABSTRACT FROM AUTHOR]

Objectives: The paper has two objectives. The first one examines whether informing women about the benefits and adverse effects of breast cancer screening could have an effect on three variables: their knowledge, the importance women attach to the future consequences of their current decisions (time perspective), and the degree to which women are worried about developing breast cancer (worry). The second one examines whether these three variables affect their intention to participate in the screening, either directly or indirectly through their feeling of regret if they do not attend the screening (anticipated regret); through their values and the support they receive in making their decisions (decisional conflict); and, through the perceived acceptability and benefits of the screening programme (attitude). Methods: Partial least squares-structural equation modelling (PLS-SEM) is used to analyse both objectives and to differentiate between direct, indirect, and moderating effects, due to the incorporation in the model of the three mediating variables (anticipated regret, decisional conflict, and attitude) and a moderating variable (educational level). Results: Information affects knowledge (objective variable), but not the behavioural variables (time perspective and worry). On the other hand, the level of knowledge has no direct or indirect effect on intention, but behavioural variables do affect it through the mediating variables. Conclusions: The variables of the planned behaviour theory are relevant to understand women's decisions and to be able to take appropriate health policy measures. Doing so, the processes of personalised screening would improve, or there would be the incorporation of shared decision-making in this context; these being demands associated with the most recent goals achieved in health programmes in many countries. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Purpose: Double reading is the strategy of choice for mammogram interpretation in screening programmes. It remains, however, unknown whether double reading is still the strategy of choice in the context of digital mammography. Our aim was to determine the effectiveness and cost-effectiveness of double reading versus single reading of digital mammograms in screening programmes.Methods: We performed a systematic review by searching the PubMed, Embase, and Cochrane Library databases up to April 2017. We used the QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies) tool and CHEERS (Consolidated Health Economic Evaluation Reporting Standards) checklist to assess the methodological quality of the diagnostic studies and economic evaluations, respectively. A proportion's meta-analysis approach, 95% Confidence Intervals (95% CI) and test of heterogeneity (P values) were used for pooled results. Costs are expressed US$ PPP (United States Dollar purchasing power parities). The PROSPERO ID of this Systematic Review's protocol is CRD42014013804.Results: Of 1473 potentially relevant hits, four high-quality studies were included. The pooled cancer detection rate of double reading was 6.01 per 1000 screens (CI: 4.47‰-7.77‰), and it was 5.65 per 1000 screens (CI: 3.95‰-7.65‰) for single reading (P=0.76). The pooled proportion of false-positives of double reading was 47.03 per 1000 screens (CI: 39.13‰-55.62‰) and it was 40.60 per 1000 screens (CI: 38.58‰-42.67‰) for single reading (P=0.12). One study reported, for double reading, an ICER (Incremental Cost-Effectiveness Ratio) of 16,684 Euros (24,717 US$ PPP; 2015 value) per detected cancer. Single reading+CAD (computer-aided-detection) was cost-effective in Japan.Conclusion: The evidence of benefit for double reading compared to single reading for digital mammography interpretation is scarce. Double reading seems to increase operational costs, have a not significantly higher false-positive rate, and a similar cancer detection rate. [ABSTRACT FROM AUTHOR]