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

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.

SUBMITTER: Perez-Lacasta MJ

PROVIDER: S-EPMC6435150 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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

Pérez-Lacasta María José MJ Martínez-Alonso Montserrat M Garcia Montse M Sala Maria M Perestelo-Pérez Lilisbeth L Vidal Carmen C Codern-Bové Núria N Feijoo-Cid Maria M Toledo-Chávarri Ana A Cardona Àngels À Pons Anna A Carles-Lavila Misericòrdia M Rue Montserrat M

PloS one 20190326 3

<h4>Background</h4>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.<h4>Methods</h4>Two-stage randomised controlled trial. In the first stage, 40 elementary territorial units of the public ...[more]

PMID: 30913217

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Project description:BackgroundThe 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.MethodsA 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.DiscussionThis 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 registrationClinicalTrials.gov registry, ID: NCT03046004 . Retrospectively registered on 4 February 2017. Trial name: InforMa study.

Project description:IntroductionWomen are largely unaware that mammography screening can cause overdetection of inconsequential disease, leading to overdiagnosis and overtreatment of breast cancer. Evidence is lacking about how information on overdetection affects women's breast screening decisions and experiences. This study investigates the consequences of providing information about overdetection of breast cancer to women approaching the age of invitation to mammography screening.Methods and analysisThis is a randomised controlled trial with an embedded longitudinal qualitative substudy. Participants are a community sample of women aged 48-50 in New South Wales, Australia, recruited in 2014. Women are randomly allocated to either quantitative only follow-up (n=904) or additional qualitative follow-up (n=66). Women in each stream are then randomised to receive either the intervention (evidence-based information booklet including overdetection, breast cancer mortality reduction and false positives) or a control information booklet (including mortality reduction and false positives only). The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions) assessed via telephone interview at 2?weeks postintervention. Secondary outcomes measured at this time include decision process (decisional conflict and confidence) and psychosocial outcomes (anticipated regret, anxiety, breast cancer worry and perceived risk). Women are further followed up at 6?months, 1 and 2?years to assess self-reported screening behaviour and long-term psychosocial outcomes (decision regret, quality of life). Participants in the qualitative stream undergo additional in-depth interviews at each time point to explore the views and experiences of women who do and do not choose to have screening.Ethics and disseminationThe study has ethical approval, and results will be published in peer-reviewed journals. This research will help ensure that information about overdetection may be communicated clearly and effectively, using an evidence-based approach, to women considering breast cancer screening.Trial registration numberAustralian New Zealand Clinical Trials Registry ACTRN12613001035718.

Project description:Informed consent is regarded as a cornerstone of ethical healthcare research and is a requirement for most clinical research studies. Guidelines suggest that prospective randomised controlled trial (RCT) participants should understand a basic amount of key information about the RCTs they are being asked to enrol in in order to provide valid informed consent. This information is usually provided to potential participants in a patient information leaflet (PIL). There is evidence that some trial participants fail to understand key components of trial processes or rationale. As such, the existing approach to information provision for potential RCT participants may not be optimal. Decision aids have been used for a variety of treatment and screening decisions to improve knowledge, but focus more on overall decision quality, and may be helpful to those making decisions about participating in an RCT. We investigated the feasibility of using a tool to identify which items recommended for good quality decision making are present in UK PILs.PILs were sampled from UK registered Clinical Trials Unit websites across a range of clinical areas. The evaluation tool, which is based on standards for supporting decision making, was applied to 20 PILs. Two researchers independently rated each PIL using the tool. In addition, word count and readability were assessed.PILs scored poorly on the evaluation tool with the majority of leaflets scoring less than 50%. Specifically, presenting probabilities, clarifying and expressing values and structured guidance in deliberation and communication sub-sections scored consistently poorly. Tool score was associated with word count (r=0.802, P <0.01); there was no association between score and readability (r=-0.372, P=0.106).The tool was feasible to use to evaluate PILs for UK RCTs. PILs did not meet current standards of information to support good quality decision making. Writers of information leaflets could use the evaluation tool as a framework during PIL development to help ensure that items are included which promote and support more informed decisions about trial participation. Further research is required to evaluate the inclusion of such information.

Project description:BACKGROUND:Women with Down syndrome have a lower breast cancer risk and significantly lower life expectancies than women without Down syndrome. Therefore, it is not clear whether mammography screening strategies used for women without Down syndrome would benefit women with Down syndrome in the same way. OBJECTIVE:To determine the benefits and harms of various mammography screening strategies for women with Down syndrome using collaborative simulation modeling. DESIGN:Two established Cancer Intervention and Surveillance Modeling Network (CISNET) simulation models estimated the benefits and harms of various screening strategies for women with Down syndrome over a lifetime horizon. PARTICIPANTS:We modeled a hypothetical cohort of US women with Down syndrome who were born in 1970. INTERVENTIONS:Annual, biennial, triennial, and one-time digital mammography screenings during the ages 40-74. MAIN MEASURES:The models estimated numbers of mammograms, false-positives, benign biopsies, breast cancer deaths prevented, and life-years gained per 1000 screened women when compared with no screening. KEY RESULTS:In average-risk women 50-74, biennial screening incurred 122 mammograms, 10 false-positive mammograms, and 1.4 benign biopsies per one life-year gained compared with no screening. In women with Down syndrome, the same screening strategy incurred 2752 mammograms, 242 false-positive mammograms, and 34 benign biopsies per one life-year gained compared with no screening. The harm/benefit ratio varied for other screening strategies, and was most favorable for one-time screening at age 50, which incurred 1629 mammograms, 144 false-positive mammograms, and 20 benign biopsies per one life-year gained compared with no screening. CONCLUSIONS:The harm/benefit ratios for various mammography screening strategies in women with Down syndrome are not as favorable as those for average-risk women. The benefit of screening mammography for women with Down syndrome is less pronounced due to lower breast cancer risk and shorter life expectancy.

Dataset Information

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

Publications

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

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