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针对无症状性腹主动脉瘤患者的治疗选择的决策辅助工具:一项随机临床试验。

A decision aid regarding treatment options for patients with an asymptomatic abdominal aortic aneurysm: a randomised clinical trial.

机构信息

Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands.

Department of Quality Assurance and Process Innovation, Academic Medical Center, Amsterdam, The Netherlands.

出版信息

Eur J Vasc Endovasc Surg. 2014 Sep;48(3):276-83. doi: 10.1016/j.ejvs.2014.04.016. Epub 2014 Jun 7.

DOI:10.1016/j.ejvs.2014.04.016
PMID:24913683
Abstract

OBJECTIVE

Abdominal aortic aneurysm patients tend to be informed inconsistently and incompletely about their disorder and the treatment options open to them. The objective of this trial was to evaluate whether these patients are better informed and experience less decisional conflict regarding their treatment options after viewing a decision aid.

DESIGN

A six-centre, randomised clinical trial comparing a decision aid plus regular information versus regular information from the surgeon.

METHODS

Included patients had recently been diagnosed with an asymptomatic abdominal aortic aneurysm at least 4 cm in diameter. The decision aid consisted of a one-time viewing of an interactive CD-ROM elaborating on elective surgery versus watchful waiting. Generally, the decision aid advised patients with aneurysms less than 5.5 cm to agree to watchful waiting, for larger aneurysms the decision aid provided insight into the balance of benefit and harm of surgical and conservative approaches, taking into account age, co-morbidity and size of the aneurysm. The primary outcome was patient decisional conflict measured at 1 month follow-up (Decisional Conflict Scale). Secondary outcomes were patient knowledge, anxiety and satisfaction.

RESULTS

In 178 aneurysm patients, decisional conflict scores did not differ significantly between the decision aid and the regular information groups (22 vs. 24 on the 0-100 Decisional Conflict Scale; p = .33). Patients in the decision aid group had significantly better knowledge (10.0 vs. 9.4 out of 13 points; p = .04), whereas anxiety levels (4.4 and 5.0 on a 0-21 scale; p = .73) and satisfaction scores (74 and 73 on a 0-100 scale; p = .81) were similar in both groups.

CONCLUSION

In addition to regular patient-surgeon communication, a decision aid helps to share treatment decisions with abdominal aortic aneurysm patients by increasing their knowledge about the disorder and available treatment options without raising anxiety levels; however, it does not reduce decisional conflict, nor does it improve satisfaction.

摘要

目的

腹主动脉瘤患者在了解自身疾病和可供选择的治疗方案时,往往会得到不一致且不完整的信息。本试验旨在评估患者在观看决策辅助工具后,对其治疗方案的了解是否会更加充分,决策冲突是否会更少。

设计

这是一项在 6 家中心开展的、比较决策辅助工具加常规信息与仅由外科医生提供常规信息的随机临床试验。

方法

入选的患者最近被诊断为至少 4cm 直径的无症状腹主动脉瘤。决策辅助工具包括一次性观看交互式 CD-ROM,详细介绍择期手术与密切观察等待的区别。通常,对于直径小于 5.5cm 的动脉瘤,决策辅助工具建议患者选择密切观察等待;对于较大的动脉瘤,决策辅助工具则提供了手术和保守方法的利弊权衡的信息,同时考虑了年龄、合并症和动脉瘤的大小。主要结局是 1 个月随访时的患者决策冲突(决策冲突量表)。次要结局是患者的知识、焦虑和满意度。

结果

在 178 例动脉瘤患者中,决策辅助工具组和常规信息组的决策冲突评分无显著差异(0-100 决策冲突量表上分别为 22 分和 24 分;p =.33)。决策辅助工具组的患者知识显著提高(13 个要点中得分为 10.0 分 vs. 9.4 分;p =.04),而焦虑水平(0-21 分量表上分别为 4.4 分和 5.0 分;p =.73)和满意度评分(0-100 分量表上分别为 74 分和 73 分;p =.81)在两组间相似。

结论

除了常规的医患沟通外,决策辅助工具还通过增加患者对疾病和可用治疗方案的了解,帮助患者共同做出治疗决策,而不会增加焦虑水平;然而,它并不能降低决策冲突,也不能提高满意度。

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