Institute for Health Economics and Clinical Epidemiology, The University Hospital of Cologne (AöR), Gleueler Straße 176-178, 50935, Cologne, Germany.
BMC Med Inform Decis Mak. 2019 Aug 1;19(1):154. doi: 10.1186/s12911-019-0872-2.
Female BRCA1 and BRCA2 mutation carriers have an increased lifetime risk of developing breast and/or ovarian cancer. Hence, they face the difficult decision of choosing a preventive strategy such as risk-reducing surgeries or intensified breast screening. To help these women during their decision process, several patient decision aids (DA) were developed and evaluated in the last 15 years. Until now, there is no conclusive evidence on the effectiveness of these DA. This study aims 1) to provide the first systematic literature review about DA addressing preventive strategy decisions for female BRCA1 and BRCA2 mutation carriers, 2) to analyze the quality of the existing evidence, 3) to evaluate the effects of DA on decision and information related outcomes, on the actual choice for preventive measure and on health outcomes.
A systematic literature review was conducted using six electronic databases (inclusion criteria: DA addressing preventive strategies, female BRCA1 and BRCA2 mutation carriers, 18 to 75 years, knowledge of test result). The quality of the included randomized controlled trials (RCT) was evaluated with the Cochrane Collaboration's risk of bias tool. The quality of included one-group pretest-posttest design studies was evaluated with the ROBINS-I tool. Outcomes of included studies were extracted and qualitatively summarized.
A total of 2093 records were identified. Six studies were included for further evaluation (5 RCT, 1 one-group pretest-posttest design study). One RCT was formally included, but data presentation did not allow for further analyses. The risk of bias was high in three RCT and unclear in one RCT. The risk of bias in the one-group pretest-posttest study was serious. The outcome assessment showed that the main advantages of DA are linked to the actual decision process: Female BRCA1 and BRCA2 mutation carriers using a DA had less decisional conflict, were more likely to reach a decision and were more satisfied with their decision.
Decision aids can support female BRCA1 and BRCA2 mutation carriers during their decision process by significantly improving decision related outcomes. More high-quality evidence is needed to evaluate possible effects on information related outcomes, health outcomes and the actual choice for preventive measures.
女性 BRCA1 和 BRCA2 基因突变携带者终生患乳腺癌和/或卵巢癌的风险增加。因此，她们面临着选择预防性策略的艰难决策，例如降低风险的手术或强化乳房筛查。为了帮助这些女性在决策过程中，在过去的 15 年中开发并评估了几种患者决策辅助工具 (DA)。到目前为止，这些 DA 的有效性还没有确凿的证据。本研究旨在：1）提供首个关于针对 BRCA1 和 BRCA2 基因突变携带者的预防性策略决策的 DA 的系统文献综述；2）分析现有证据的质量；3）评估 DA 对决策和信息相关结果、实际预防性措施选择以及健康结果的影响。
使用六个电子数据库进行系统文献综述（纳入标准：针对预防性策略的 DA，女性 BRCA1 和 BRCA2 基因突变携带者，18 至 75 岁，了解检测结果）。使用 Cochrane 协作风险偏倚工具评估纳入的随机对照试验 (RCT) 的质量。使用 ROBINS-I 工具评估纳入的单组测试前后设计研究的质量。提取纳入研究的结果并进行定性总结。
共确定了 2093 条记录。有 6 项研究被纳入进一步评估（5 项 RCT，1 项单组测试前后设计研究）。有 1 项 RCT 被正式纳入，但数据呈现不允许进一步分析。三项 RCT 的偏倚风险较高，一项 RCT 的偏倚风险不明确。单组测试前后设计研究的偏倚风险严重。结果评估表明，DA 的主要优势与实际决策过程相关：使用 DA 的 BRCA1 和 BRCA2 基因突变携带者的决策冲突较少，更有可能做出决策，并对其决策更满意。
决策辅助工具可以通过显著改善决策相关结果来支持 BRCA1 和 BRCA2 基因突变携带者的决策过程。需要更多高质量的证据来评估对信息相关结果、健康结果和实际预防性措施选择的可能影响。
