Division of General Medicine, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Division of Geriatric Medicine, Department of Medicine, The University of North Carolina at Chapel Hill.
JAMA Intern Med. 2020 Jun 1;180(6):831-842. doi: 10.1001/jamainternmed.2020.0440.
Guidelines recommend that women 75 years and older be informed of the benefits and harms of mammography before screening.
To test the effects of receipt of a paper-based mammography screening decision aid (DA) for women 75 years and older on their screening decisions.
DESIGN, SETTING, AND PARTICIPANTS: A cluster randomized clinical trial with clinician as the unit of randomization. All analyses were completed on an intent-to-treat basis. The setting was 11 primary care practices in Massachusetts or North Carolina. Of 1247 eligible women reached, 546 aged 75 to 89 years without breast cancer or dementia who had a mammogram within 24 months but not within 6 months and saw 1 of 137 clinicians (herein referred to as PCPs) from November 3, 2014, to January 26, 2017, participated. A research assistant (RA) administered a previsit questionnaire on each participant's health, breast cancer risk factors, sociodemographic characteristics, and screening intentions. After the visit, the RA administered a postvisit questionnaire on screening intentions and knowledge.
Receipt of the DA (DA arm) or a home safety (HS) pamphlet (control arm) before a PCP visit.
Participants were followed up for 18 months for receipt of mammography screening (primary outcome). To examine the effects of the DA, marginal logistic regression models were fit using generalized estimating equations to allow for clustering by PCP. Adjusted probabilities and risk differences were estimated to account for clustering by PCP.
Of 546 women in the study, 283 (51.8%) received the DA. Patients in each arm were well matched; their mean (SD) age was 79.8 (3.7) years, 428 (78.4%) were non-Hispanic white, 321 (of 543 [59.1%]) had completed college, and 192 (35.2%) had less than a 10-year life expectancy. After 18 months, 9.1% (95% CI, 1.2%-16.9%) fewer women in the DA arm than in the control arm had undergone mammography screening (51.3% vs 60.4%; adjusted risk ratio, 0.84; 95% CI, 0.75-0.95; P = .006). Women in the DA arm were more likely than those in the control arm to rate their screening intentions lower from previsit to postvisit (69 of 283 [adjusted %, 24.5%] vs 47 of 263 [adjusted %, 15.3%]), to be more knowledgeable about the benefits and harms of screening (86 [adjusted %, 25.5%] vs 32 [adjusted %, 11.7%]), and to have a documented discussion about mammography with their PCP (146 [adjusted %, 47.4%] vs 111 [adjusted %, 38.9%]). Almost all women in the DA arm (94.9%) would recommend the DA.
Providing women 75 years and older with a mammography screening DA before a PCP visit helps them make more informed screening decisions and leads to fewer women choosing to be screened, suggesting that the DA may help reduce overscreening.
ClinicalTrials.gov Identifier: NCT02198690.
指南建议，对 75 岁及以上的女性在进行筛查前，告知其接受乳房 X 线摄影筛查的获益和危害。
检测为 75 岁及以上女性提供纸质乳房 X 线摄影筛查决策辅助工具（DA）对其筛查决策的影响。
设计、设置和参与者：这是一项采用临床医生作为随机分组单位的聚类随机临床试验。所有分析均基于意向治疗原则进行。研究地点为马萨诸塞州或北卡罗来纳州的 11 家初级保健诊所。在 2014 年 11 月 3 日至 2017 年 1 月 26 日期间，符合条件的 1247 名女性中，有 546 名年龄在 75 岁至 89 岁之间、无乳腺癌或痴呆症、在 24 个月内且不在 6 个月内进行过乳房 X 线摄影检查、且由 137 名初级保健医生（以下简称 PCP）中的 1 名接诊的女性参与了研究。一名研究助理（RA）在每位参与者就诊前对其健康状况、乳腺癌风险因素、社会人口统计学特征和筛查意向进行了问卷调查。就诊后，RA 对其筛查意向和知识进行了问卷调查。
在 PCP 就诊前，接受 DA（DA 组）或家庭安全（HS）小册子（对照组）。
对参与者进行了 18 个月的随访，以了解其接受乳房 X 线摄影筛查的情况（主要结局）。为了检验 DA 的效果，使用广义估计方程对边际逻辑回归模型进行拟合，以允许按 PCP 进行聚类。调整后的概率和风险差异用于解释由 PCP 引起的聚类。
在 546 名研究参与者中，283 名（51.8%）接受了 DA。每组患者均匹配良好；其平均（标准差）年龄为 79.8（3.7）岁，428 名（78.4%）为非西班牙裔白人，321 名（543 名中的 59.1%）完成了大学学业，192 名（35.2%）预期寿命不足 10 年。18 个月后，DA 组接受乳房 X 线摄影筛查的女性比例（95%CI，1.2%-16.9%）比对照组低 9.1%（51.3%比 60.4%；调整后的风险比，0.84；95%CI，0.75-0.95；P=0.006）。与对照组相比，DA 组的女性在就诊前到就诊后更有可能降低其筛查意向评分（283 名中的 69 名[调整后百分比，24.5%]比 263 名中的 47 名[调整后百分比，15.3%]），对筛查的获益和危害有更深入的了解（283 名中的 86 名[调整后百分比，25.5%]比 263 名中的 32 名[调整后百分比，11.7%]），并且与 PCP 就乳房 X 线摄影检查进行了记录在案的讨论（283 名中的 146 名[调整后百分比，47.4%]比 263 名中的 111 名[调整后百分比，38.9%]）。几乎所有 DA 组的女性（94.9%）都会推荐该 DA。
在 PCP 就诊前为 75 岁及以上的女性提供乳房 X 线摄影筛查 DA 有助于她们做出更明智的筛查决策，并导致更少的女性选择筛查，这表明 DA 可能有助于减少过度筛查。
ClinicalTrials.gov 标识符：NCT02198690。
