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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.

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.

A mesura que els pacients prenen consciència de ser usuaris del Sistema Nacional de Salut, demanen una prestació no relacionada només en resoldre el seu problema de salut de manera oportuna, sinó que també inclogui un bon acompanyament per part dels professionals, de manera que aconsegueixin un millor benestar. És a dir, sentir-se escoltat, rebre informació comprensible, ser tractat amb empatia i poder-se involucrar en les decisions que afecten la seva salut, sembla que són elements importants a considerar. Així ho han entès els diferents sistemes de salut, que han declarat com a centre del model els pacients, encara que de vegades sigui un desafiament portar-lo a la pràctica diària. La Presa de Decisions Compartides (TDC) pot ser una alternativa per concretar una atenció més participativa i centrada en el pacient, i models com "The Three-talk" faciliten la seva aplicació en situacions específiques de salut o malaltia. En aquest context, en el cribratge de càncer de mama, les dones tenen una baixa implicació a l'hora de decidir la seva participació, ja que no tenen ni un espai ni un temps específic on poder expressar els seus temors, dubtes o preferències a un professional de la salut, i moltes vegades manca informació sobre els beneficis i efectes adversos de participar en el cribratge. Més encara, elles no visualitzen aquestes mancances com una necessitat, perquè està molt interioritzat el benefici d'una detecció precoç com l'únic resultat possible i desconeixen o minimitzen els efectes adversos que coexisteixen amb el cribratge: falsos positius, falsos negatius o sobrediagnòstic. Aquesta tesi té per finalitat contribuir al desenvolupament d'una salut més participativa en l'àmbit del cribratge de càncer de mama, en un context de Sistema Nacional de Salut, utilitzant el model de TDC. Així, els resultats de tres estudis han permès: 1) conèixer les barreres i facilitadors per a l'aplicació de la TDC des de la perspectiva dels professionals de la salut, 2) crear dos documents –manual i guia– que ofereixen suport empíric als professionals de la salut per involucrar les dones en la presa de decisions del cribratge; 3) entendre les preferències de les dones comparant la significació dels atributs que defineixen el model de salut convencional i un amb incorporació d'una TDC. A medida que los pacientes toman conciencia como usuarios del Sistema Nacional de Salud, demandan prestaciones relacionadas no sólo con la resolución óptima de su problema de salud, sino una atención que también incluya un buen acompañamiento por parte de los profesionales, de forma que consigan un mejor bienestar. Es decir, sentirse escuchado, recibir información comprensible, ser tratado con empatía y poder involucrarse en las decisiones que afectan a su salud parecen ser elementos importantes que considerar. Así lo han entendido los diferentes sistemas de salud, que han declarado, como centro del modelo, a los pacientes, aunque en ocasiones sea un desafío llevarlo a la práctica diaria. La Toma de Decisiones Compartidas (TDC) puede ser una alternativa para concretar una atención más participativa y centrada en el paciente, y modelos como “The Three-talk model” facilitan su aplicación en situaciones específicas de salud o enfermedad. En este contexto, en el cribado de cáncer de mama, las mujeres tienen una baja implicación a la hora de decidir su participación, puesto que no tienen ni un espacio ni un tiempo específico donde poder expresar sus temores, dudas o preferencias a un profesional sanitario, y muchas veces carece de información sobre los beneficios y efectos adversos de participar en el cribado. Más aún, ellas no visualizan estas carencias como una necesidad, porque está muy interiorizado el beneficio de una detección precoz como el único resultado posible y desconocen o minimizan los efectos adversos que coexisten con el cribado: falsos positivos, falsos negativos o sobrediagnóstico. Esta tesis tiene por finalidad contribuir al desarrollo de una salud más participativa en el ámbito del cribado de cáncer de mama, en un contexto de Sistema Nacional de Salud, utilizando el modelo de TDC. Se realizaron tres estudios que han permitido: 1) conocer las barreras y facilitadores para la aplicación de la TDC desde la perspectiva de los profesionales de la salud, 2) crear dos documentos –manual y guía– que ofrecen soporte empírico a los profesionales sanitarios para involucrar a las mujeres en la toma de decisiones del cribado; 3) entender las preferencias de las mujeres comparando la significación de los atributos que definen el modelo de salud convencional y uno con incorporación de una TDC. As the awareness of patients as users of the national health system increases, they demand more well-being, which is not only related to solving their problem, but also a good accompaniment by health professionals. That is, feeling heard, receiving understandable information, being treated with empathy, and getting involved in decisions that affect your health seem to be important elements to consider. This has been understood by the different health systems, which have declared patients as the center of the model, although it is sometimes a challenge to put it into routine practice. Shared Decision-making (SDM) could be an alternative for more participatory and patient-centered care, as well as “The Three-talk” model would simplify its application in specific health or disease situations. In this context, women in breast cancer screening have a low involvement in the decision to participate, since they do not have a space in which to express their fears, doubts, or preferences to a health professional, and do not have sufficient information on the benefits and adverse effects of participating in screening. Even worse, they do not see these deficiencies as a necessity, since the benefit of early detection is very much internalized as the only possible result and they do not know or minimize the adverse effects they may suffer due to screening: false positives, false negatives or overdiagnosis. This thesis aims to contribute to the development of a more participatory health in the context of breast cancer screening in a context of the National Health System, using the SDM model. Three studies were carried out: 1) to know the barriers and facilitators for the application of the SDM from the perspective of health professionals, 2) create two documents, manual and guide, to give practical support to health professionals to involve women in the screening decision, 3) to know the preferences of women by comparing the attributes of the conventional health model and one with the incorporation of an SDM.