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

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.

A dynamic web-based decision aid to improve informed choice in organised breast cancer screening. A pragmatic randomised trial in Italy

“…More women responded correctly to the false positive question than to the false negative one (both in DA and in SB). This is in line with the findings by Perez-La Casta 31 in the InforMa trial conducted in a similar screening programme setting in Spain. Considering other studies on DAs and perception of women towards screenings, 32 the risk of false positive results is known by women and underlined by information conveyed to women more often than the false negative one.…”

“…Participating women had a high level of education, which limits the generalisability of findings, in agreement with other studies. 22,31,34 Most of the participants had already had a mammography before the invitation to the organised screening programme. This suggests that many had already received information that could have fostered the attitude and intention reported in this study.…”

“…Perez-La Casta 31 in the InforMa trial assessed the effect of receiving information about benefits and harms of BC screening on informed choice in women likely to be invited in organised programmes. Spanish 50-year-old women were randomly selected and allocated to a DA or an SB where harms were not mentioned.…”

“…Like the InforMa 31 and Reder 34 studies, our study was part of organised BC screening programmes, facilitating the adoption of the DA in standard practice, in addition to well-balanced informative leaflets, as the one developed within our study.…”

Lessons Learned to Promote Lung Cancer Screening and Preempt Worsening Lung Cancer Disparities

“…For example, studies of underserved Appalachian smokers highlight the importance of tailored messages to raise hope rather than invoke stigma in lung cancer screening materials (14). Finding the optimal balance of information on benefits and harms of lung cancer screening to support shared decision making without overwhelming patients from disadvantaged backgrounds remains challenging, but lessons can be learned from prior breast and prostate cancer screening studies (7,15). Thus, by using historical lessons learned from cancer screening in other organ sites, healthcare systems can develop and test lung cancer screening interventions to ensure that lung cancer screening is implemented in a way that addresses, rather than exacerbates, disparities in lung cancer mortality.…”