Impact of population based breast density notification: multisite parallel arm randomised controlled trial in BreastScreen.

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Názov: Impact of population based breast density notification: multisite parallel arm randomised controlled trial in BreastScreen.
Autori: Nickel B; Sydney Health Literacy Lab, School of Public Health, The University of Sydney, Sydney, NSW, Australia brooke.nickel@sydney.edu.au.; Wiser Healthcare, School of Public Health, The University of Sydney, Sydney, NSW, Australia., Ormiston-Smith N; Cancer Screening Unit, Queensland Department of Health, Brisbane, QLD, Australia., Cvejic E; Sydney Health Literacy Lab, School of Public Health, The University of Sydney, Sydney, NSW, Australia., Isautier J; Sydney Health Literacy Lab, School of Public Health, The University of Sydney, Sydney, NSW, Australia.; Wiser Healthcare, School of Public Health, The University of Sydney, Sydney, NSW, Australia., Hammerton L; BreastScreen Queensland Sunshine Coast Service, Nambour, QLD, Australia., Baker K; BreastScreen Queensland Brisbane Northside Service, Brisbane, QLD, Australia., Legerton P; Cancer Screening Unit, Queensland Department of Health, Brisbane, QLD, Australia., Vardon P; Cancer Screening Unit, Queensland Department of Health, Brisbane, QLD, Australia., McInally Z; Cancer Screening Unit, Queensland Department of Health, Brisbane, QLD, Australia., Robertson S; Public representative, BreastScreen Queensland Consumer Reference Group., McCaffery K; Sydney Health Literacy Lab, School of Public Health, The University of Sydney, Sydney, NSW, Australia.; Wiser Healthcare, School of Public Health, The University of Sydney, Sydney, NSW, Australia., Houssami N; Wiser Healthcare, School of Public Health, The University of Sydney, Sydney, NSW, Australia.; The Daffodil Centre, The University of Sydney and Cancer Council NSW, Sydney, NSW, Australia.
Zdroj: BMJ (Clinical research ed.) [BMJ] 2025 Dec 03; Vol. 391, pp. e083649. Date of Electronic Publication: 2025 Dec 03.
Spôsob vydávania: Journal Article; Randomized Controlled Trial; Multicenter Study
Jazyk: English
Informácie o časopise: Publisher: British Medical Association Country of Publication: England NLM ID: 8900488 Publication Model: Electronic Cited Medium: Internet ISSN: 1756-1833 (Electronic) Linking ISSN: 09598138 NLM ISO Abbreviation: BMJ Subsets: MEDLINE
Imprint Name(s): Original Publication: London : British Medical Association
Výrazy zo slovníka MeSH: Breast Density* , Breast Neoplasms*/psychology , Breast Neoplasms*/diagnosis , Breast Neoplasms*/diagnostic imaging , Mammography*/psychology , Early Detection of Cancer*/psychology , Early Detection of Cancer*/methods , Mass Screening*/methods , Mass Screening*/psychology, Humans ; Female ; Middle Aged ; Queensland ; Adult ; Health Literacy ; Aged ; Anxiety
Abstrakt: Objective: To investigate the effect of notifying women of their dense breasts on their psychosocial outcomes and health service use intentions.
Design: Multisite parallel arm randomised controlled trial.
Setting: Population based breast screening programme in Queensland, Australia.
Participants: Women aged ≥40 years having screening and classified as having mammographically dense breasts (BI-RADS C-D from automated density measure).
Intervention: Women were randomised equally to standard care (no notification of breast density), notification of breast density plus written health literacy sensitive information (intervention 1), or notification of density plus a link to online video based health literacy sensitive information (intervention 2).
Main Outcome Measures: Psychological (feeling anxious, confused, or informed) and health service use intentions (general practitioner consultation related to breast density, supplemental screening) at 8 weeks post-screening.
Results: Between September 2023 and July 2024, 3107 women (1030 control, 1003 intervention 1, and 1074 intervention 2) were randomised, and 2401 women (802 control, 776 intervention 1, and 823 intervention 2) with a mean age at baseline of 57.4 (standard deviation 9.9) years were included in the analysis. Compared with the control group, women who were notified of their dense breasts reported feeling significantly more anxious (intervention 1: odds ratio 1.30, 95% confidence interval (CI) 1.08 to 1.57; intervention 2: odds ratio 1.28, 1.07 to 1.54) and confused (intervention 1: odds ratio 1.92, 1.58 to 2.33; intervention 2: odds ratio 1.76, 1.46 to 2.13) and had significantly higher intentions to talk to their general practitioner about their screening results (intervention1: relative risk ratio 2.08, 95% CI 1.59 to 2.73; intervention 2: relative risk ratio 1.71, 1.31 to 2.25) and to rely on their general practitioner for supplemental screening advice (intervention 1: relative risk ratio 2.61, 1.80 to 3.79; intervention 2: relative risk ratio 2.29, 1.58 to 3.33). However, most women did not intend to have supplemental screening (control: 91.3%; intervention 1: 78.9%; intervention 2: 81.4%). Notified women did not feel more informed (intervention 1: odds ratio 0.83, 0.68 to 1.01; intervention 2: odds ratio 0.80, 0.66 to 0.97).
Conclusions: Women notified of their dense breasts felt anxious and confused, did not feel more informed to make decisions about their breast health, and wanted to be guided by their general practitioners. Notification of breast density as part of population based breast screening may have adverse outcomes including additional consultation burden on general practitioners to advise women.
Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN12623000001695).
(© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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Entry Date(s): Date Created: 20251203 Date Completed: 20251203 Latest Revision: 20251207
Update Code: 20251207
PubMed Central ID: PMC12673659
DOI: 10.1136/bmj-2024-083649
PMID: 41338600
Databáza: MEDLINE
Popis
Abstrakt:Objective: To investigate the effect of notifying women of their dense breasts on their psychosocial outcomes and health service use intentions.<br />Design: Multisite parallel arm randomised controlled trial.<br />Setting: Population based breast screening programme in Queensland, Australia.<br />Participants: Women aged ≥40 years having screening and classified as having mammographically dense breasts (BI-RADS C-D from automated density measure).<br />Intervention: Women were randomised equally to standard care (no notification of breast density), notification of breast density plus written health literacy sensitive information (intervention 1), or notification of density plus a link to online video based health literacy sensitive information (intervention 2).<br />Main Outcome Measures: Psychological (feeling anxious, confused, or informed) and health service use intentions (general practitioner consultation related to breast density, supplemental screening) at 8 weeks post-screening.<br />Results: Between September 2023 and July 2024, 3107 women (1030 control, 1003 intervention 1, and 1074 intervention 2) were randomised, and 2401 women (802 control, 776 intervention 1, and 823 intervention 2) with a mean age at baseline of 57.4 (standard deviation 9.9) years were included in the analysis. Compared with the control group, women who were notified of their dense breasts reported feeling significantly more anxious (intervention 1: odds ratio 1.30, 95% confidence interval (CI) 1.08 to 1.57; intervention 2: odds ratio 1.28, 1.07 to 1.54) and confused (intervention 1: odds ratio 1.92, 1.58 to 2.33; intervention 2: odds ratio 1.76, 1.46 to 2.13) and had significantly higher intentions to talk to their general practitioner about their screening results (intervention1: relative risk ratio 2.08, 95% CI 1.59 to 2.73; intervention 2: relative risk ratio 1.71, 1.31 to 2.25) and to rely on their general practitioner for supplemental screening advice (intervention 1: relative risk ratio 2.61, 1.80 to 3.79; intervention 2: relative risk ratio 2.29, 1.58 to 3.33). However, most women did not intend to have supplemental screening (control: 91.3%; intervention 1: 78.9%; intervention 2: 81.4%). Notified women did not feel more informed (intervention 1: odds ratio 0.83, 0.68 to 1.01; intervention 2: odds ratio 0.80, 0.66 to 0.97).<br />Conclusions: Women notified of their dense breasts felt anxious and confused, did not feel more informed to make decisions about their breast health, and wanted to be guided by their general practitioners. Notification of breast density as part of population based breast screening may have adverse outcomes including additional consultation burden on general practitioners to advise women.<br />Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN12623000001695).<br /> (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
ISSN:1756-1833
DOI:10.1136/bmj-2024-083649