Trial reportPloS one2019
Effect of information about the benefits and harms of mammography on women's decision making: The InforMa randomised controlled trial.
Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03046004 (The Effect of Receiving Information About the Benefits and Harms of Mammography Screening on Women's Decision Making), which is not on this map. Cited by 27 papers, 6 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Effect of Receiving Information About the Benefits and Harms of Mammography Screening on Women's Decision Making
Who cites it
27 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Advancing Mammographic Screening Among Underserved Groups: A Systematic Review and Meta-Analysis of Intervention Strategies to Increase Breast Cancer Screening Uptake.Public health reviews · 2025Pooled it
- Patient preferences for breast cancer screening: a systematic review update to inform recommendations by the Canadian Task Force on Preventive Health Care.Systematic reviews · 2024Pooled it
- Shared decision-making for supporting women's decisions about breast cancer screening.The Cochrane database of systematic reviews · 2024Pooled it
- Decision aids for people facing health treatment or screening decisions.The Cochrane database of systematic reviews · 2024Pooled it
- Factors promoting breast, cervical and colorectal cancer screenings participation: A systematic review.Psycho-oncology · 2022Pooled it
- Evaluate the effectiveness of breast cancer decision aids: A systematic review and meta-analysis of randomize clinical trails.Nursing open · 2021Pooled it
- Preferences for the Use of Artificial Intelligence for Breast Cancer Screening in Australia: A Discrete Choice Experiment.The patient · 2025Trial
- Evaluation of a Web-Based Culturally Sensitive Educational Video to Facilitate Informed Cervical Cancer Screening Decisions Among Turkish- and Moroccan-Dutch Women Aged 30 to 60 Years: Randomized Intervention Study.Journal of medical Internet research · 2022Trial
- Informing Women About Overdetection in Breast Cancer Screening: Two-Year Outcomes From a Randomized Trial.Journal of the National Cancer Institute · 2021Trial
- Effect of an information leaflet on breast cancer screening participation: A cluster randomized controlled trial.BMC public health · 2021Trial
- [Enlightenment through official vaccination communication: an experimental study comparing evidence-based fact boxes with nudges and advertising].Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2025Article
- Evaluating the use of SPIRIT on participant retention in randomised trials: Challenges in reporting and implications for practice.PloS one · 2025Article
- How do women comply with cancer screenings? A study in four regions of France.BMC women's health · 2023Article
- To Consent or Not to Consent to Screening, That Is the Question.Healthcare (Basel, Switzerland) · 2023Article
- RE: Informing women about overdetection in breast cancer screening: Two-year outcomes from a randomized trial.Journal of the National Cancer Institute · 2023Article
- Breast cancer: a randomized controlled trial assessing the effect of a decision aid on mammography screening uptake: study protocol.Frontiers in oncology · 2023Article
- Factors influencing intention to participate in breast cancer screening. An exploratory structural model.PloS one · 2023Article
- Women's preference to apply shared decision-making in breast cancer screening: a discrete choice experiment.BMJ open · 2022Article
- The Relationship between Healthcare Providers and Preventive Practices: Narratives on Access to Cancer Screening.International journal of environmental research and public health · 2022Article
- Feasibility and Acceptability of Personalized Breast Cancer Screening (DECIDO Study): A Single-Arm Proof-of-Concept Trial.International journal of environmental research and public health · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn 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.
methodsTwo-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.
resultsIn 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.
conclusionsWomen 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 registrationTrial identifier NCT03046004 at ClinicalTrials.gov registry. Registered on February 4 2017. Trial name: InforMa study.
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