Family and Community Medicine Division, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Associate Cochrane Centre, Instituto Universitario Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Cochrane Database Syst Rev. 2024 May 10;5(5):CD013822. doi: 10.1002/14651858.CD013822.pub2.
In breast cancer screening programmes, women may have discussions with a healthcare provider to help them decide whether or not they wish to join the breast cancer screening programme. This process is called shared decision-making (SDM) and involves discussions and decisions based on the evidence and the person's values and preferences. SDM is becoming a recommended approach in clinical guidelines, extending beyond decision aids. However, the overall effect of SDM in women deciding to participate in breast cancer screening remains uncertain.
To assess the effect of SDM on women's satisfaction, confidence, and knowledge when deciding whether to participate in breast cancer screening.
We searched the Cochrane Breast Cancer Group's Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform on 8 August 2023. We also screened abstracts from two relevant conferences from 2020 to 2023.
We included parallel randomised controlled trials (RCTs) and cluster-RCTs assessing interventions targeting various components of SDM. The focus was on supporting women aged 40 to 75 at average or above-average risk of breast cancer in their decision to participate in breast cancer screening.
Two review authors independently assessed studies for inclusion and conducted data extraction, risk of bias assessment, and GRADE assessment of the certainty of the evidence. Review outcomes included satisfaction with the decision-making process, confidence in the decision made, knowledge of all options, adherence to the chosen option, women's involvement in SDM, woman-clinician communication, and mental health.
We identified 19 studies with 64,215 randomised women, mostly with an average to moderate risk of breast cancer. Two studies covered all aspects of SDM; six examined shortened forms of SDM involving communication on risks and personal values; and 11 focused on enhanced communication of risk without other SDM aspects. SDM involving all components compared to control The two eligible studies did not assess satisfaction with the SDM process or confidence in the decision. Based on a single study, SDM showed uncertain effects on participant knowledge regarding the age to start screening (risk ratio (RR) 1.18, 95% confidence interval (CI) 0.61 to 2.28; 133 women; very low certainty evidence) and frequency of testing (RR 0.84, 95% CI 0.68 to 1.04; 133 women; very low certainty evidence). Other review outcomes were not measured. Abbreviated forms of SDM with clarification of values and preferences compared to control Of the six included studies, none evaluated satisfaction with the SDM process. These interventions may reduce conflict in the decision made, based on two measures, Decisional Conflict Scale scores (mean difference (MD) -1.60, 95% CI -4.21 to 0.87; conflict scale from 0 to 100; 4 studies; 1714 women; very low certainty evidence) and the proportion of women with residual conflict compared to control at one to three months' follow-up (rate of women with a conflicted decision, RR 0.75, 95% CI 0.56 to 0.99; 1 study; 1001 women, very low certainty evidence). Knowledge of all options was assessed through knowledge scores and informed choice. The effect of SDM may enhance knowledge (MDs ranged from 0.47 to 1.44 higher scores on a scale from 0 to 10; 5 studies; 2114 women; low certainty evidence) and may lead to higher rates of informed choice (RR 1.24, 95% CI 0.95 to 1.63; 4 studies; 2449 women; low certainty evidence) compared to control at one to three months' follow-up. These interventions may result in little to no difference in anxiety (MD 0.54, 95% -0.96 to 2.14; scale from 20 to 80; 2 studies; 749 women; low certainty evidence) and the number of women with worries about cancer compared to control at four to six weeks' follow-up (RR 0.88, 95% CI 0.73 to 1.06; 1 study, 639 women; low certainty evidence). Other review outcomes were not measured. Enhanced communication about risks without other SDM aspects compared to control Of 11 studies, three did not report relevant outcomes for this review, and none assessed satisfaction with the SDM process. Confidence in the decision made was measured by decisional conflict and anticipated regret of participating in screening or not. These interventions, without addressing values and preferences, may result in lower confidence in the decision compared to regular communication strategies at two weeks' follow-up (MD 2.89, 95% CI -2.35 to 8.14; Decisional Conflict Scale from 0 to 100; 2 studies; 1191 women; low certainty evidence). They may result in higher anticipated regret if participating in screening (MD 0.28, 95% CI 0.15 to 0.41) and lower anticipated regret if not participating in screening (MD -0.28, 95% CI -0.42 to -0.14). These interventions increase knowledge (MD 1.14, 95% CI 0.61 to 1.62; scale from 0 to 10; 4 studies; 2510 women; high certainty evidence), while it is unclear if there is a higher rate of informed choice compared to regular communication strategies at two to four weeks' follow-up (RR 1.27, 95% CI 0.83 to 1.92; 2 studies; 1805 women; low certainty evidence). These interventions result in little to no difference in anxiety (MD 0.33, 95% CI -1.55 to 0.99; scale from 20 to 80) and depression (MD 0.02, 95% CI -0.41 to 0.45; scale from 0 to 21; 2 studies; 1193 women; high certainty evidence) and lower cancer worry compared to control (MD -0.17, 95% CI -0.26 to -0.08; scale from 1 to 4; 1 study; 838 women; high certainty evidence). Other review outcomes were not measured.
AUTHORS' CONCLUSIONS: Studies using abbreviated forms of SDM and other forms of enhanced communications indicated improvements in knowledge and reduced decisional conflict. However, uncertainty remains about the effect of SDM on supporting women's decisions. Most studies did not evaluate outcomes considered important for this review topic, and those that did measured different concepts. High-quality randomised trials are needed to evaluate SDM in diverse cultural settings with a focus on outcomes such as women's satisfaction with choices aligned to their values.
在乳腺癌筛查计划中，女性可能会与医疗保健提供者进行讨论，以帮助她们决定是否希望加入乳腺癌筛查计划。这个过程被称为共享决策（SDM），涉及基于证据和个人价值观和偏好的讨论和决策。SDM 正在成为临床指南中的推荐方法，超越了决策辅助。然而，女性决定参与乳腺癌筛查的 SDM 的总体效果仍然不确定。
评估 SDM 在女性决定是否参与乳腺癌筛查时对其满意度、信心和知识的影响。
我们于 2023 年 8 月 8 日在 Cochrane 乳腺癌组的专门注册库、CENTRAL、MEDLINE、Embase、CINAHL、PsycINFO、ClinicalTrials.gov 和世界卫生组织国际临床试验注册平台上进行了检索。我们还从 2020 年到 2023 年的两次相关会议中筛选了摘要。
我们纳入了针对各种 SDM 干预措施的平行随机对照试验（RCT）和群组 RCT。重点是支持 40 至 75 岁、平均或以上乳腺癌风险的女性做出参与乳腺癌筛查的决定。
两名综述作者独立评估了纳入研究的情况，并进行了数据提取、偏倚风险评估和证据确定性的 GRADE 评估。综述结果包括对决策过程的满意度、对所做决策的信心、对所有选项的了解、对所选选项的遵守、女性参与 SDM、医患沟通和心理健康。
我们确定了 19 项研究，涉及 64215 名随机女性，其中大多数为平均至中度乳腺癌风险。两项研究涵盖了 SDM 的所有方面；六项研究检查了涉及风险和个人价值观沟通的简短形式的 SDM；十一项研究侧重于增强风险沟通而不涉及其他 SDM 方面。涉及所有组成部分的 SDM 与对照组相比，两项符合条件的研究均未评估 SDM 过程的满意度或对决策的信心。基于一项研究，SDM 对开始筛查的年龄（RR 1.18，95%置信区间（CI）0.61 至 2.28；133 名女性；非常低确定性证据）和检测频率（RR 0.84，95%CI 0.68 至 1.04；133 名女性；非常低确定性证据）的参与者知识产生了不确定的影响。其他综述结果未被衡量。与对照组相比，具有明确价值偏好的 SDM 简短形式与对照组相比，六项纳入研究中，没有一项评估了对 SDM 过程的满意度。这些干预措施可能会减少决策中的冲突，基于两项措施，决策冲突量表评分（MD-1.60，95%CI-4.21 至 0.87；冲突量表从 0 到 100；4 项研究；1714 名女性；非常低确定性证据）和与对照组相比，在一至三个月的随访中具有残余冲突的女性比例（RR0.75，95%CI0.56 至 0.99；1 项研究；1001 名女性，非常低确定性证据）。通过知识得分和知情选择评估了所有选项的知识。SDM 的效果可能会提高知识（MD 范围为 0.47 至 1.44，分数范围为 0 至 10；5 项研究；2114 名女性；低确定性证据），并可能导致知情选择率更高（RR1.24，95%CI0.95 至 1.63；4 项研究；2449 名女性；低确定性证据）与一至三个月的随访相比。这些干预措施可能导致焦虑程度（MD0.54，95%CI0.96 至 2.14；20 至 80 分量表；2 项研究；749 名女性；低确定性证据）和与对照组相比在四周至六周随访时出现担忧癌症的女性人数（RR0.88，95%CI0.73 至 1.06；1 项研究，639 名女性；低确定性证据）没有差异。其他综述结果未被衡量。与对照组相比，不涉及其他 SDM 方面的风险增强沟通研究中，有 11 项研究没有报告本综述的相关结果，也没有评估对 SDM 过程的满意度。通过决策冲突和参与筛查或不参与筛查的预期后悔来衡量对所做决策的信心。这些干预措施，而不解决价值观和偏好，可能导致与常规沟通策略相比，在两周随访时对决策的信心较低（MD2.89，95%CI-2.35 至 8.14；决策冲突量表从 0 到 100；2 项研究；1191 名女性；低确定性证据）。如果参与筛查，它们可能导致更高的预期后悔（MD0.28，95%CI0.15 至 0.41），如果不参与筛查，它们可能导致更低的预期后悔（MD-0.28，95%CI-0.42 至-0.14）。这些干预措施增加了知识（MD1.14，95%CI0.61 至 1.62；0 至 10 分量表；4 项研究；2510 名女性；高确定性证据），而与常规沟通策略相比，尚不清楚在两至四周的随访中是否有更高的知情选择率（RR1.27，95%CI0.83 至 1.92；2 项研究；1805 名女性；低确定性证据）。这些干预措施导致焦虑（MD0.33，95%CI-1.55 至 0.99；20 至 80 分量表）和抑郁（MD0.02，95%CI-0.41 至 0.45；0 至 21 分量表；2 项研究；1193 名女性；高确定性证据）和癌症担忧较低（MD-0.17，95%CI-0.26 至-0.08；1 项研究；838 名女性；高确定性证据）与对照组相比。其他综述结果未被衡量。
使用简化的 SDM 形式和其他形式的增强沟通的研究表明，知识和决策冲突有所改善。然而，SDM 支持女性决策的效果仍不确定。大多数研究没有评估本综述主题的重要结果，而且那些进行了评估的研究测量了不同的概念。需要高质量的随机试验来评估在具有不同文化背景的人群中，SDM 与个人价值观相一致的选择方面的效果。
