{
  "abstract": "Objectives Internationally the ongoing debate about the benefits and harms of implementing population-based breast density notification lacks robust outcomes data. This trial investigated the effect of notifying women with dense breasts of their density on their psychosocial outcomes and health services use intention.Method Co-designed randomised controlled trial conducted through the population-based breast screening program in Queensland, Australia. Women aged ≥40 years classified as having mammographically-dense breasts (BI-RADS C-D) were randomised (1:1:1) to standard care (control: no notification of breast density), notification of breast density plus a hard-copy written health literacy-sensitive information (intervention-1), or notification of density plus a link to online written and video-based health literacy-sensitive information (intervention-2). Primary outcomes were psychological and health service use intentions post-screening; analyses used linear and generalised linear models. A sub-set of women in intervention-1 and 2 also completed qualitative semi-structured interviews.Results Between September 2023 to July 2024, 1030 women were allocated to the control arm, 1003 women to intervention-1 and 1074 to intervention-2 (with 228, 227 and 251 women lost-to-follow-up respectively). 802 women in the control, 776 in intervention-1 and 823 in intervention-2 were included in the primary analyses. No significant differences were found for agreement that notification made women feel anxious (control vs intervention-1, p=0.14) or informed to make decisions regarding breast health (control vs intervention-1 (p=0.58) or intervention-2 (p=0.58)). Significant differences were found for feeling anxious (control vs intervention-2, p=0.001) or confused (control vs intervention-1 (p<0.001) or intervention-2 (p<0.001); and in proportions of women intending to discuss results with doctor (control vs intervention-1 (p<0.001) or intervention-2 (p<0.001)) or to go for additional screening tests (control vs intervention-1 (p<0.001) or intervention-2 (p=0.006)).Conclusions Women notified of their dense breasts are confused, do not feel more informed to make decisions regarding their breasts, are interested in additional screening and want to be guided by their doctors. The utility of implementing population-based breast density notification should be further considered to ensure that the benefits outweigh any potential harms, including overdiagnosis, for women and the health system.",
  "authors": [
    {
      "affiliations": [
        "The University of Sydney, Sydney, Australia"
      ],
      "name": "Brooke Nickel"
    },
    {
      "affiliations": [
        "Queensland Department of Health, Brisbane, Australia"
      ],
      "name": "Nick Ormiston-Smith"
    },
    {
      "affiliations": [
        "The University of Sydney, Sydney, Australia"
      ],
      "name": "Erin Cvejic"
    },
    {
      "affiliations": [
        "The University of Sydney, Sydney, Australia"
      ],
      "name": "Jennifer Isautier"
    },
    {
      "affiliations": [
        "BreastScreen Queensland, Sunshine Coast, Australia"
      ],
      "name": "Lisa Hammerton"
    },
    {
      "affiliations": [
        "BreastScreen Queensland, Brisbane Northside, Australia"
      ],
      "name": "Karen Baker"
    },
    {
      "affiliations": [
        "Queensland Department of Health, Brisbane, Australia"
      ],
      "name": "Paula Legerton"
    },
    {
      "affiliations": [
        "Queensland Department of Health, Brisbane, Australia"
      ],
      "name": "Paul Vardon"
    },
    {
      "affiliations": [
        "BreastScreen Queensland Consumer Reference Group, Brisbane, Australia"
      ],
      "name": "Sandy Robertson"
    },
    {
      "affiliations": [
        "The University of Sydney, Sydney, Australia"
      ],
      "name": "Kirsten McCaffery"
    },
    {
      "affiliations": [
        "The University of Sydney, Sydney, Australia"
      ],
      "name": "Nehmat Houssami"
    }
  ],
  "title": "010 A randomised controlled trial of population-based breast density notification: do the benefits outweigh the harms for women and the health system?",
  "uid": "616e9758-6701-557e-87a9-c6655accf6e6"
}