Nagle Cate, Lewis Sharon, Meiser Bettina, Metcalfe Sylvia, Carlin John B, Bell Robin, Gunn Jane, Halliday Jane
Murdoch Childrens Research Institute, Flemington Road, Parkville, Victoria, 3052, Australia.
BMC Public Health. 2006 Apr 13;6:96. doi: 10.1186/1471-2458-6-96.
By providing information on the relative merits and potential harms of the options available and a framework to clarify preferences, decision aids can improve knowledge and realistic expectations and decrease decisional conflict in individuals facing decisions between alternative forms of action. Decision-making about prenatal testing for fetal abnormalities is often confusing and difficult for women and the effectiveness of decision aids in this field has not been established. This study aims to test whether a decision aid for prenatal testing of fetal abnormalities, when compared to a pamphlet, improves women's informed decision-making and decreases decisional conflict.
METHODS/DESIGN: A cluster designed randomised controlled trial is being conducted in Victoria, Australia. Fifty General Practitioners (GPs) have been randomised to one of two arms: providing women with either a decision aid or a pamphlet. The two primary outcomes will be measured by comparing the difference in percentages of women identified as making an informed choice and the difference in mean decisional conflict scores between the two groups. Data will be collected from women using questionnaires at 14 weeks and 24 weeks gestation. The sample size of 159 women in both arms of the trial has been calculated to detect a difference of 18% (50 to 68%) in informed choice between the two groups. The required numbers have been adjusted to accommodate the cluster design, miscarriage and participant lost--to--follow up. Baseline characteristics of women will be summarised for both arms of the trial. Similarly, characteristics of GPs will be compared between arms. Differences in the primary outcomes will be analysed using 'intention-to-treat' principles. Appropriate regression techniques will adjust for the effects of clustering and include covariates to adjust for the stratifying variable and major potential confounding factors.
The findings from this trial will make a significant contribution to improving women's experience of prenatal testing and will have application to a variety of maternity care settings. The evaluation of a tailored decision aid will also have implications for pregnancy care providers by identifying whether or not such a resource will support their role in providing prenatal testing information.
通过提供有关可用选项的相对优点和潜在危害的信息以及一个明确偏好的框架，决策辅助工具可以提高知识水平和现实期望，并减少面临不同行动方案决策的个人的决策冲突。对于女性来说，关于胎儿异常的产前检测决策往往令人困惑且困难，而该领域决策辅助工具的有效性尚未得到证实。本研究旨在测试与一本宣传册相比，胎儿异常产前检测的决策辅助工具是否能改善女性的知情决策并减少决策冲突。
方法/设计：在澳大利亚维多利亚州进行一项整群设计的随机对照试验。五十名全科医生（GP）被随机分为两组之一：为女性提供决策辅助工具或宣传册。通过比较两组中被确定做出知情选择的女性百分比差异以及平均决策冲突得分差异来衡量两个主要结果。将在妊娠14周和24周时使用问卷从女性中收集数据。计算出试验两组中各159名女性的样本量，以检测两组之间知情选择上18%（50%至68%）的差异。所需数量已进行调整以适应整群设计、流产和失访情况。将汇总试验两组女性的基线特征。同样，将比较两组全科医生的特征。将使用“意向性分析”原则分析主要结果的差异。适当的回归技术将调整聚类效应，并纳入协变量以调整分层变量和主要潜在混杂因素的影响。
该试验的结果将对改善女性的产前检测体验做出重大贡献，并将适用于各种产科护理环境。对定制决策辅助工具的评估还将通过确定此类资源是否有助于妊娠护理提供者在提供产前检测信息方面的作用而对其产生影响。
