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

• Published in: PloS one Vol. 14; no. 3; p. e0214057
• Main Authors: Pérez-Lacasta, María José, Martínez-Alonso, Montserrat, Garcia, Montse, Sala, Maria, Perestelo-Pérez, Lilisbeth, Vidal, Carmen, Codern-Bové, Núria, Feijoo-Cid, Maria, Toledo-Chávarri, Ana, Cardona, Àngels, Pons, Anna, Carles-Lavila, Misericòrdia, Rue, Montserrat
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 26.03.2019; Public Library of Science (PLoS)
• Subjects: Anxiety; Attitudes; Biology and Life Sciences; Biomedical research; Breast cancer; Breast Neoplasms - diagnostic imaging; Cancer; Cancer screening; Choice Behavior; Control methods; Decision Making; Decision Support Techniques; Disease prevention; Early Detection of Cancer; Economics; Epidemiology; Female; Funding; Health aspects; Health care; Health Knowledge, Attitudes, Practice; Health services; Humans; Internet; Intervention; Mammography; Mammography - adverse effects; Mammography - psychology; Mass Screening; Medical personnel; Medical research; Medical screening; Medicine and Health Sciences; Middle Aged; Outcome Assessment, Health Care; Patient Participation; Patients; People and places; Prostate cancer; Qualitative research; Randomization; Research and Analysis Methods; Retirement benefits; Risk Assessment; Screening; Social Sciences; Software; Spain; Womens health; Spain; Canary Islands; United Kingdom > UK; United States > US; Tenerife
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0214057

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. 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. 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. 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 identifier NCT03046004 at ClinicalTrials.gov registry. Registered on February 4 2017. Trial name: InforMa study.