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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.

  • Datos identificativos

    Identificador: imarina:3410821
    Handle: https://hdl.handle.net/20.500.11797/imarina3410821
    Autores:
    Carles M, Martínez-Alonso M, Pons A, Pérez-Lacasta MJ, Perestelo-Pérez L, Sala M, Vidal C, Garcia M, Toledo-Chávarri A, Codern N, Feijoo-Cid M, Romero A, Pla R, Soler-González J, Castells X, Rué M, InforMa Group
    Resumen:
    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.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.This is the first

  • Otros:

    Autor según el artículo: Carles M, Martínez-Alonso M, Pons A, Pérez-Lacasta MJ, Perestelo-Pérez L, Sala M, Vidal C, Garcia M, Toledo-Chávarri A, Codern N, Feijoo-Cid M, Romero A, Pla R, Soler-González J, Castells X, Rué M, InforMa Group
    Departamento: Medicina i Cirurgia Economia
    Autor/es de la URV: Carles Lavila, Misericòrdia / Pérez Lacasta, Maria José / Pla Farnòs, Roger Jesús
    Palabras clave: Screening Informed choice Elecció informada a l'entorn sanitari: disseminació de la informació entre els consumidors per la seva presa de decisions Elaboració de materials per ajudar a prendre decisions informades Early detection Decision aids Breast cancer
    Resumen: 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.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.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.ClinicalTrials.gov registry, ID: NCT03046004 . Retrospectively registered on 4 February 2017. Trial name: InforMa study.
    Áreas temáticas: Saúde coletiva Psicología Pharmacology (medical) Odontología Nutrição Medicine, research & experimental Medicine (miscellaneous) Medicina iii Medicina ii Medicina i Materiais Interdisciplinar Engenharias iv Enfermagem Educação física Ciências biológicas iii Ciências biológicas ii Ciências ambientais Biotecnología Administração pública e de empresas, ciências contábeis e turismo
    Acceso a la licencia de uso: https://creativecommons.org/licenses/by/3.0/es/
    ISSN: 17456215
    Direcció de correo del autor: rogerjesus.pla@urv.cat mariajose.perez@urv.cat misericordia.carles@urv.cat
    Identificador del autor: 0000-0002-3727-8933 0000-0001-5906-5632 0000-0003-3796-3014
    Fecha de alta del registro: 2024-09-07
    Versión del articulo depositado: info:eu-repo/semantics/publishedVersion
    Enlace a la fuente original: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2161-7#citeas
    URL Documento de licencia: https://repositori.urv.cat/ca/proteccio-de-dades/
    Referencia al articulo segun fuente origial: Trials. 18 (426): 1-8
    Referencia de l'ítem segons les normes APA: Carles M, Martínez-Alonso M, Pons A, Pérez-Lacasta MJ, Perestelo-Pérez L, Sala M, Vidal C, Garcia M, Toledo-Chávarri A, Codern N, Feijoo-Cid M, Romero (2017). The effect of information about the benefits and harms of mammography on women's decision-making: study protocol for a randomized controlled trial.. Trials, 18(426), 1-8. DOI: 10.1186/s13063-017-2161-7
    DOI del artículo: 10.1186/s13063-017-2161-7
    Entidad: Universitat Rovira i Virgili
    Año de publicación de la revista: 2017
    Tipo de publicación: Journal Publications

  • Palabras clave:

    Medicine (Miscellaneous),Medicine, Research & Experimental,Pharmacology (Medical)
    Screening
    Informed choice
    Elecció informada a l'entorn sanitari: disseminació de la informació entre els consumidors per la seva presa de decisions
    Elaboració de materials per ajudar a prendre decisions informades
    Early detection
    Decision aids
    Breast cancer
    Saúde coletiva
    Psicología
    Pharmacology (medical)
    Odontología
    Nutrição
    Medicine, research & experimental
    Medicine (miscellaneous)
    Medicina iii
    Medicina ii
    Medicina i
    Materiais
    Interdisciplinar
    Engenharias iv
    Enfermagem
    Educação física
    Ciências biológicas iii
    Ciências biológicas ii
    Ciências ambientais
    Biotecnología
    Administração pública e de empresas, ciências contábeis e turismo

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