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The effect of information about the benefits and harms of mammography on women's decision-making: study protocol for a randomized controlled trial

  • Identification data

    Identifier: PC:3241
  • Authors:

    Carles, Misericòrida, Pérez-Lacasta, María José
    Pla Farnòs, Roger Jesús
  • Others:

    Author, as appears in the article.: Carles, Misericòrida, Pérez-Lacasta, María José; Pla Farnòs, Roger Jesús
    Department: Economia
    Keywords: Càncer de mamella Mamografia Cancer de mama Mamografía Screening Breast Cancer Informed choice
    Abstract: 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.
    Research group: Grup de Recerca en Anàlisi Econòmica i Salut
    Thematic Areas: Economia i empresa Economía y empresa Economics and business
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    ISSN: 1745-6215
    Author identifier: 0000-0003-3796-3014; 0000-0001-5906-5632; 0000-0002-3727-8933
    Record's date: 2018-04-18
    Journal volume: 18
    Papper version: info:eu-repo/semantics/publishedVersion
    Link to the original source:
    Article's DOI: 10.1186/s13063-017-2161-7
    Entity: Universitat Rovira i Virgili
    Journal publication year: 2017
    Publication Type: Article Artículo Article
  • Keywords:

    Presa de decisió
    Dones presa de decisions
    Càncer de mamella
    Cancer de mama
    Breast Cancer
    Informed choice
    Economia i empresa
    Economía y empresa
    Economics and business
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