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提高血管外科学中的共同决策:一项阶梯式楔形群随机试验。

Improving Shared Decision Making in Vascular Surgery: A Stepped Wedge Cluster Randomised Trial.

机构信息

Department of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands; Department of Radiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.

Department of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands.

出版信息

Eur J Vasc Endovasc Surg. 2022 Jul;64(1):73-81. doi: 10.1016/j.ejvs.2022.04.016. Epub 2022 Apr 26.

Abstract

OBJECTIVE

Different treatment options are available and feasible for various vascular surgical disorders. Hence, vascular surgery seems an area par excellence for shared decision making (SDM), in which clinicians incorporate the patient's preferences into the final treatment decision. However, current SDM levels in vascular surgical outpatient clinics are below expectations. To improve this, different decision support tools (DSTs) have been developed: online patient decision aids, consultation cards, and decision cards.

METHODS

This stepped wedge cluster randomised trial was conducted in 13 Dutch hospitals. Besides the developed DSTs, training on how to apply SDM during the clinician patient encounter was used in this study. Data were obtained via questionnaires and audio recordings. The primary outcome was the OPTION-5 score, an objective tool to assess the level of SDM, expressed as a percentage of exemplary performance. Main secondary outcomes were patients' disease specific knowledge, consultation duration, and treatment choice. Factors influencing OPTION-5 scores were studied using linear regression analysis.

RESULTS

Included in the study were 342 patients with an abdominal aortic aneurysm (AAA; n = 87), intermittent claudication (IC; n = 143), or varicose veins (VV; n = 112). Audiotapes of 395 consultations were analysed. Overall the mean OPTION-5 score significantly improved from 28.7% to 37.8% (mean difference 9.1%, 95% CI 6.5% - 11.8%) after implementation of the DSTs. Also, patient knowledge increased significantly (median increase: 13%, effect size: 0.13, p = .025). The number of patients choosing non-surgical treatment choices increased, with 21.4% to 28.8% for patients with AAA and doubled (16.0% to 32.0%) among patients with IC. For surgeons, the SDM training and for patients the decision aid significantly and independently increased OPTION-5 scores (p < .001 and p = .047, respectively).

CONCLUSION

Introducing DSTs improves the level of shared decision making in vascular surgery, improves patient knowledge, and shifts their preference towards more non-surgical treatments. The SDM training for clinicians and the decision aid for patients appeared the most effective means of improving SDM.

TRIAL REGISTRATION

NTR6487.

摘要

目的

各种血管外科疾病都有不同的治疗选择,且这些选择都切实可行。因此,血管外科似乎是共享决策(SDM)的卓越领域,临床医生可以将患者的偏好纳入最终的治疗决策中。然而,目前血管外科门诊的 SDM 水平低于预期。为了提高这一水平,已经开发了不同的决策支持工具(DST):在线患者决策辅助工具、咨询卡和决策卡。

方法

本研究采用了递进式楔形集群随机试验,在 13 家荷兰医院进行。除了开发的 DST 之外,本研究还使用了培训,以在临床医生与患者的就诊过程中应用 SDM。通过问卷和录音获得数据。主要结局指标是 OPTION-5 评分,这是一种评估 SDM 水平的客观工具,以表现出色的百分比表示。主要次要结局指标是患者的疾病相关知识、咨询时间和治疗选择。使用线性回归分析研究了影响 OPTION-5 评分的因素。

结果

本研究纳入了 342 名患有腹主动脉瘤(AAA;n=87)、间歇性跛行(IC;n=143)或静脉曲张(VV;n=112)的患者。分析了 395 次咨询的录音。总体而言,在实施 DST 后,OPTION-5 评分从 28.7%显著提高到 37.8%(平均差异 9.1%,95%CI 6.5% - 11.8%)。此外,患者的知识也显著增加(中位数增加 13%,效应大小 0.13,p=.025)。选择非手术治疗方案的患者人数增加,AAA 患者从 21.4%增加到 28.8%,IC 患者增加了一倍(从 16.0%增加到 32.0%)。对于外科医生来说,SDM 培训和患者的决策辅助工具显著且独立地提高了 OPTION-5 评分(p<.001 和 p=.047)。

结论

引入 DST 可提高血管外科的 SDM 水平,提高患者的知识水平,并促使他们更倾向于选择非手术治疗。临床医生的 SDM 培训和患者的决策辅助工具似乎是提高 SDM 的最有效手段。

试验注册

NTR6487。

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