Department of Epidemiology and Evaluation, IMIM (Hospital del Mar Medical Research Institute), Passeig Marítim 25-29, 08003, Barcelona, Spain.
Preventive Medicine and Public Health Training Unit PSMar-ASPB-UPF, Passeig Marítim 25-29, 08003, Barcelona, Spain.
BMC Public Health. 2021 Jul 3;21(1):1301. doi: 10.1186/s12889-021-11360-0.
To evaluate the impact of an information leaflet about the risk-benefit balance of breast cancer screening on women's participation.
This cluster randomized controlled trial was conducted within a population-based breast cancer screening program and included women from the catchment areas of two hospitals in Barcelona, Spain. We evaluated women aged 50-69 years invited to screening between September 2019 and January 2020. The intervention group received an information leaflet on the benefits and harms of mammography screening. The control group received the usual invitation letter. The clusters consisted of the processing days of the invitation letter, assigned to the intervention with a simple random allocation scheme. We compared the participation rate at the individual level between groups, stratified by hospital and by per-protocol and intention-to-treat analyses.
We included 11,119 women (137 clusters): 5416 in the intervention group (66 clusters) and 5703 in the control group (71 clusters). A total of 36% (1964/5393) of the women in the intervention group and 37% (2135/5694) of those in the control group attended screening, respectively. Overall, we found no differences in participation among groups (difference in participation - 1.1%; 95%CI; - 2.9 to 0.7%). In a hospital attending a population with a low socioeconomic status, attendance was lower in the intervention group (- 1.4, 95%CI: - 5.7% to - 0.03%).
Overall participation in our program was unaffected by a new information leaflet on the risk-benefit balance of breast cancer screening. However, participation was lower in certain populations with lower socioeconomic status TRIAL REGISTRATION: Trial registration number ISRCTN13848929 .
评估关于乳腺癌筛查风险-获益平衡的信息单页对女性参与度的影响。
这是一项在基于人群的乳腺癌筛查计划内开展的、采用整群随机对照试验设计的研究，纳入了来自西班牙巴塞罗那两家医院的筛查对象。我们评估了 2019 年 9 月至 2020 年 1 月期间受邀参加筛查的 50-69 岁女性。干预组收到了一份关于乳腺 X 线筛查的获益和危害的信息单页，而对照组则收到了常规的邀请信。各聚类由邀请信的处理日组成，采用简单随机分配方案将其分配到干预组。我们按医院分层，在个体水平上比较了两组之间的参与率，并分别进行了意向性治疗分析和符合方案分析。
我们纳入了 11119 名女性（137 个聚类）：干预组 5416 名（66 个聚类），对照组 5703 名（71 个聚类）。干预组中有 36%（1964/5393）的女性接受了筛查，而对照组中有 37%（2135/5694）的女性接受了筛查。总体而言，两组之间的参与率没有差异（差异为 1.1%；95%CI：-2.9%至 0.7%）。在一家服务于社会经济地位较低人群的医院中，干预组的参与率较低（-1.4%，95%CI：-5.7%至 -0.03%）。
总体而言，我们的方案中新增的乳腺癌筛查风险-获益平衡信息单页并未对参与度产生影响。然而，在社会经济地位较低的人群中，参与度较低。
临床试验注册号 ISRCTN84522364 。
