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      Effect of information about the benefits and harms of mammography on women’s decision making: The InforMa randomised controlled trial

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          Abstract

          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.

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          Most cited references18

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          European guidelines for quality assurance in breast cancer screening and diagnosis. Fourth edition--summary document.

          Breast cancer is a major cause of suffering and death and is of significant concern to many women. Early detection of breast cancer by systematic mammography screening can find lesions for which treatment is more effective and generally more favourable for quality of life. The potential harm caused by mammography includes the creation of unnecessary anxiety and morbidity, inappropriate economic cost and the use of ionising radiation. It is for this reason that the strongest possible emphasis on quality control and quality assurance is required. Development of the European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis has been an initiative within the Europe Against Cancer Programme. The fourth edition of the multidisciplinary guidelines was published in 2006 and comprises approximately 400 pages divided into 12 chapters prepared by >200 authors and contributors. The multidisciplinary editorial board has prepared a summary document to provide an overview of the fundamental points and principles that should support any quality screening or diagnostic service. This document includes a summary table of key performance indicators and is presented here in order to make these principles and standards known to a wider scientific community.
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            The use of citizens' juries in health policy decision-making: a systematic review.

            Deliberative inclusive approaches, such as citizen juries, have been used to engage citizens on a range of issues in health care and public health. Researchers engaging with the public to inform policy and practice have adapted the citizen jury method in a variety of ways. The nature and impact of these adaptations has not been evaluated. We systematically searched Medline (PubMED), CINAHL and Scopus databases to identify deliberative inclusive methods, particularly citizens' juries and their adaptations, deployed in health research. Identified studies were evaluated focussing on principles associated with deliberative democracy: inclusivity, deliberation and active citizenship. We examined overall process, recruitment, evidence presentation, documentation and outputs in empirical studies, and the relationship of these elements to theoretical explications of deliberative inclusive methods. The search yielded 37 papers describing 66 citizens' juries. The review demonstrated that the citizens' jury model has been extensively adapted. Inclusivity has been operationalised with sampling strategies that aim to recruit representative juries, although these efforts have produced mixed results. Deliberation has been supported through use of steering committees and facilitators to promote fair interaction between jurors. Many juries were shorter duration than originally recommended, limiting opportunity for constructive dialogue. With respect to citizenship, few juries' rulings were considered by decision-making bodies thereby limiting transfer into policy and practice. Constraints in public policy process may preclude use of the 'ideal' citizens' jury with potential loss of an effective method for informed community engagement. Adapted citizens' jury models provide an alternative: however, this review demonstrates that special attention should be paid to recruitment, independent oversight, jury duration and moderation. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.
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              Women's perception of the benefits of mammography screening: population-based survey in four countries.

              Screening programmes are often actively promoted to achieve high coverage, which may result in unrealistic expectations. We examined women's understanding of the likely benefits of mammography screening. Telephone survey of random samples of the female population aged > or =15 years in the US, UK, Italy, and Switzerland using three closed questions on the expected benefits of mammography screening. A total of 5964 women were contacted and 4140 women (69%) participated. Misconceptions were widespread: a majority of women believed that screening prevents or reduces the risk of contracting breast cancer (68%), that screening at least halves breast cancer mortality (62%), and that 10 years of regular screening will prevent 10 or more breast cancer deaths per 1000 women (75%). In multivariate analysis higher number of correct answers was positively associated with higher educational status (odds ratio [OR] = 1.44, 95% CI: 1.25, 1.66) and negatively with having had a mammography in the last 2 years (OR = 0.86, 95% CI: 0.73, 1.01). Compared with US women (reference group) and Swiss women (OR = 0.98, 95% CI: 0.82, 1.18) respondents in Italy (OR = 0.61, 95% CI: 0.50, 0.74) and the UK (OR = 0.73, 95% CI: 0.60, 0.88) gave fewer correct answers. In the US and three European countries a high proportion of women overestimated the benefits that can be expected from screening mammography. This finding raises doubts on informed consent procedures within breast cancer screening programmes.
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                Author and article information

                Contributors
                Role: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: SoftwareRole: ValidationRole: VisualizationRole: Writing – review & editing
                Role: Data curationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: ValidationRole: Writing – review & editing
                Role: Data curationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: ValidationRole: Writing – review & editing
                Role: Data curationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: ValidationRole: Writing – review & editing
                Role: Data curationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: ValidationRole: Writing – review & editing
                Role: Data curationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: ValidationRole: Writing – review & editing
                Role: Data curationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: ValidationRole: Writing – review & editing
                Role: Data curationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: ValidationRole: Writing – review & editing
                Role: Data curationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: ValidationRole: Writing – review & editing
                Role: Data curationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SoftwareRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                2019
                26 March 2019
                : 14
                : 3
                : e0214057
                Affiliations
                [1 ] Department of Economics, University Rovira i Virgili, Reus, Spain
                [2 ] Research Group on Statistics, Economic Evaluation and Health (GRAEES), Reus, Spain
                [3 ] Research Centre on Industrial and Public Economics, (CREIP), Reus, Spain
                [4 ] Department of Basic Medical Sciences, University of Lleida-IRBLLEIDA, Lleida, Spain
                [5 ] Lleida Biomedical Research Institute (IRBLLEIDA), Lleida, Spain
                [6 ] Cancer Prevention and Control Program, Catalan Institute of Oncology-IDIBELL, L’Hospitalet de Llobregat, Spain
                [7 ] Department of Epidemiology and Evaluation, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain
                [8 ] Health Services Research on Chronic Patients Network (REDISSEC), Madrid, Spain
                [9 ] Evaluation Unit of the Canary Islands Health Service (SESCS), Tenerife, Spain
                [10 ] ÀreaQ, Evaluation and Qualitative Research, Barcelona, Spain
                [11 ] Nursing and Occupational Therapy School (EUIT), Universitat Autònoma de Barcelona, Terrassa, Spain
                [12 ] Department of Nursing, Faculty of Medicine, Universitat Autònoma de Barcelona, Bellaterra, Spain
                [13 ] Grup de REcerca Multidisciplinar en SAlut i Societat (GREMSAS), Barcelona, Spain
                [14 ] Canary Islands Foundation of Health Research (FUNCANIS), Tenerife, Spain
                [15 ] Catalan Health Institut (ICS), Lleida, Spain
                University of Texas MD Anderson Cancer Center, UNITED STATES
                Author notes

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

                ¶ Membership list can be found in the Acknowledgments section.

                Author information
                http://orcid.org/0000-0002-3437-3185
                http://orcid.org/0000-0002-7010-373X
                http://orcid.org/0000-0003-3796-3014
                http://orcid.org/0000-0002-7862-9365
                Article
                PONE-D-18-25123
                10.1371/journal.pone.0214057
                6435150
                30913217
                0065686c-61d3-4e6e-9313-3f41651a775a
                © 2019 Pérez-Lacasta et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 29 August 2018
                : 1 March 2019
                Page count
                Figures: 2, Tables: 5, Pages: 20
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/501100004587, Instituto de Salud Carlos III;
                Award ID: PI14/00113
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000005, Fondo Europeo de Desarrollo Regional (FEDER), "Una manera de hacer Europa";
                Award ID: PI14/00113
                Award Recipient :
                Funded by: IRBLleida
                Award ID: Predoc grant for Anna Pons
                Award Recipient :
                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.
                Categories
                Research Article
                Medicine and Health Sciences
                Diagnostic Medicine
                Cancer Detection and Diagnosis
                Cancer Screening
                Medicine and Health Sciences
                Oncology
                Cancer Detection and Diagnosis
                Cancer Screening
                Medicine and Health Sciences
                Oncology
                Cancers and Neoplasms
                Breast Tumors
                Breast Cancer
                Biology and Life Sciences
                Neuroscience
                Cognitive Science
                Cognitive Psychology
                Decision Making
                Biology and Life Sciences
                Psychology
                Cognitive Psychology
                Decision Making
                Social Sciences
                Psychology
                Cognitive Psychology
                Decision Making
                Biology and Life Sciences
                Neuroscience
                Cognitive Science
                Cognition
                Decision Making
                Medicine and Health Sciences
                Public and Occupational Health
                Health Screening
                Research and Analysis Methods
                Research Design
                Survey Research
                Questionnaires
                Medicine and Health Sciences
                Diagnostic Medicine
                Diagnostic Radiology
                Mammography
                Research and Analysis Methods
                Imaging Techniques
                Diagnostic Radiology
                Mammography
                Medicine and Health Sciences
                Radiology and Imaging
                Diagnostic Radiology
                Mammography
                People and places
                Geographical locations
                Europe
                European Union
                Spain
                Biology and Life Sciences
                Psychology
                Psychometrics
                Social Sciences
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                Psychometrics
                Custom metadata
                All relevant data are available from Dryad at doi: 10.5061/dryad.ft0207r.

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