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

María José Pérez-Lacasta, Montserrat Martínez-Alonso, Montse Garcia, Maria Sala, Lilisbeth Perestelo-Pérez, Carmen Vidal, Núria Codern-Bové, Maria Feijoo-Cid, Ana Toledo-Chávarri, Àngels Cardona, Anna Pons, Misericòrdia Carles-Lavila, Montserrat Rue, with the InforMa Group, María José Pérez-Lacasta, Montserrat Martínez-Alonso, Montse Garcia, Maria Sala, Lilisbeth Perestelo-Pérez, Carmen Vidal, Núria Codern-Bové, Maria Feijoo-Cid, Ana Toledo-Chávarri, Àngels Cardona, Anna Pons, Misericòrdia Carles-Lavila, Montserrat Rue, with the InforMa Group

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.

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. CONSORT flow diagram.
Fig 1. CONSORT flow diagram.
Fig 2. Relative mean scores on knowledge…
Fig 2. Relative mean scores on knowledge subscales, with respect to the maximum available score.
Bars width indicate the contribution of the available marks for each subscale to the total available marks.

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Source: PubMed

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