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

Methods

Multisite parallel arm randomised controlled trial.

多中心平行组随机对照试验。

Population based breast screening programme in Queensland, Australia.

澳大利亚昆士兰州基于人群的乳腺筛查计划。

Women aged ≥40 years having screening and classified as having mammographically dense breasts (BI-RADS C-D from automated density measure).

年龄≥40岁的女性接受了筛查，并被分类为具有乳腺X线摄影密度高的乳房（从自动密度测量中分类为BI-RADS C-D）。

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).

女性被随机均等地分配到标准护理（不通知乳腺密度）、通知乳腺密度并提供书面健康素养敏感信息（干预1），或通知密度并提供链接到在线视频形式的健康素养敏感信息（干预2）。

Methods

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.

在筛查后8周，评估心理状态（感到焦虑、困惑或了解情况）和健康服务使用意向（与乳腺密度相关的全科医生咨询、补充筛查）。

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.

在2023年9月至2024年7月期间，共有3107名女性（对照组1030名，干预组1共1003名，干预组2共1074名）被随机分配，最终有2401名女性（对照组802名，干预组1共776名，干预组2共823名）纳入分析，她们的基线平均年龄为57.4岁（标准差9.9岁）。

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).

与对照组相比，被告知自己乳腺密度较高的女性报告感到显著更焦虑（干预组1：比值比1.30，95%置信区间（CI）1.08至1.57；干预组2：比值比1.28，1.07至1.54）和困惑（干预组1：比值比1.92，1.58至2.33；干预组2：比值比1.76，1.46至2.13），并且她们与全科医生讨论筛查结果的意向显著更高（干预组1：相对风险比2.08，95% CI 1.59至2.73；干预组2：相对风险比1.71，1.31至2.25），以及依赖全科医生获取补充筛查建议的意向也显著更高（干预组1：相对风险比2.61，1.80至3.79；干预组2：相对风险比2.29，1.58至3.33）。

However, most women did not intend to have supplemental screening (control: 91.3%; intervention 1: 78.9%; intervention 2: 81.4%).

然而，大多数女性并不打算进行额外筛查（对照组：91.3%；干预1组：78.9%；干预2组：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).

被通知的女性并没有感到更加了解情况（干预1组：比值比0.83，95%置信区间0.68至1.01；干预2组：比值比0.80，95%置信区间0.66至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.

告知女性其乳腺密度高后，她们感到焦虑和困惑，不觉得自己更有信息做出关于乳腺健康的决策，并希望由全科医生指导。

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.

将乳腺密度告知作为基于人群的乳腺筛查的一部分可能会产生不良后果，包括增加全科医生咨询负担，以指导女性。

trial_registration

Australian New Zealand Clinical Trials Registry (ACTRN12623000001695).

澳大利亚新西兰临床试验注册处(ACTRN12623000001695)。