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PLoS One. 2019 Mar 26;14(3):e0214057. doi: 10.1371/journal.pone.0214057. eCollection 2019.

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

Author information

1
Department of Economics, University Rovira i Virgili, Reus, Spain.
2
Research Group on Statistics, Economic Evaluation and Health (GRAEES), Reus, Spain.
3
Department of Basic Medical Sciences, University of Lleida-IRBLLEIDA, Lleida, Spain.
4
Lleida Biomedical Research Institute (IRBLLEIDA), Lleida, Spain.
5
Cancer Prevention and Control Program, Catalan Institute of Oncology-IDIBELL, L'Hospitalet de Llobregat, Spain.
6
Department of Epidemiology and Evaluation, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.
7
Health Services Research on Chronic Patients Network (REDISSEC), Madrid, Spain.
8
Evaluation Unit of the Canary Islands Health Service (SESCS), Tenerife, Spain.
9
ÀreaQ, Evaluation and Qualitative Research, Barcelona, Spain.
10
Nursing and Occupational Therapy School (EUIT), Universitat Autònoma de Barcelona, Terrassa, Spain.
11
Department of Nursing, Faculty of Medicine, Universitat Autònoma de Barcelona, Bellaterra, Spain.
12
Grup de REcerca Multidisciplinar en SAlut i Societat (GREMSAS), Barcelona, Spain.
13
Canary Islands Foundation of Health Research (FUNCANIS), Tenerife, Spain.
14
Catalan Health Institut (ICS), Lleida, Spain.
15
Research Centre on Industrial and Public Economics, (CREIP), Reus, Spain.

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.

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