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决策辅助工具对腹主动脉瘤修复类型与患者偏好一致性的影响:一项随机临床试验。

Effect of a Decision Aid on Agreement Between Patient Preferences and Repair Type for Abdominal Aortic Aneurysm: A Randomized Clinical Trial.

机构信息

Department of Surgery and VA Outcomes Group, White River Junction VA Medical Center, White River Junction, Vermont.

Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.

出版信息

JAMA Surg. 2022 Sep 1;157(9):e222935. doi: 10.1001/jamasurg.2022.2935. Epub 2022 Sep 14.

DOI:10.1001/jamasurg.2022.2935
PMID:35947375
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9366657/
Abstract

IMPORTANCE

Patients with abdominal aortic aneurysm (AAA) can choose open repair or endovascular repair (EVAR). While EVAR is less invasive, it requires lifelong surveillance and more frequent aneurysm-related reinterventions than open repair. A decision aid may help patients receive their preferred type of AAA repair.

OBJECTIVE

To determine the effect of a decision aid on agreement between patient preference for AAA repair type and the repair type they receive.

DESIGN, SETTING, AND PARTICIPANTS: In this cluster randomized trial, 235 patients were randomized at 22 VA vascular surgery clinics. All patients had AAAs greater than 5.0 cm in diameter and were candidates for both open repair and EVAR. Data were collected from August 2017 to December 2020, and data were analyzed from December 2020 to June 2021.

INTERVENTIONS

Presurgical consultation using a decision aid vs usual care.

MAIN OUTCOMES AND MEASURES

The primary outcome was the proportion of patients who had agreement between their preference and their repair type, measured using χ2 analyses, κ statistics, and adjusted odds ratios.

RESULTS

Of 235 included patients, 234 (99.6%) were male, and the mean (SD) age was 73 (5.9) years. A total of 126 patients were enrolled in the decision aid group, and 109 were enrolled in the control group. Within 2 years after enrollment, 192 (81.7%) underwent repair. Patients were similar between the decision aid and control groups by age, sex, aneurysm size, iliac artery involvement, and Charlson Comorbidity Index score. Patients preferred EVAR over open repair in both groups (96 of 122 [79%] in the decision aid group; 81 of 106 [76%] in the control group; P = .60). Patients in the decision aid group were more likely to receive their preferred repair type than patients in the control group (95% agreement [93 of 98] vs 86% agreement [81 of 94]; P = .03), and κ statistics were higher in the decision aid group (κ = 0.78; 95% CI, 0.60-0.95) compared with the control group (κ = 0.53; 95% CI, 0.32-0.74). Adjusted models confirmed this association (odds ratio of agreement in the decision aid group relative to control group, 2.93; 95% CI, 1.10-7.70).

CONCLUSIONS AND RELEVANCE

Patients exposed to a decision aid were more likely to receive their preferred AAA repair type, suggesting that decision aids can help better align patient preferences and treatments in major cardiovascular procedures.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03115346.

摘要

重要性

患有腹主动脉瘤(AAA)的患者可以选择开放修复或血管内修复(EVAR)。虽然 EVAR 的侵入性较小,但与开放修复相比,它需要终身监测,并需要更频繁地进行与动脉瘤相关的再介入治疗。决策辅助工具可能有助于患者获得他们首选的 AAA 修复类型。

目的

确定决策辅助工具对患者对 AAA 修复类型的偏好与他们接受的修复类型之间的一致性的影响。

设计、地点和参与者:在这项聚类随机试验中,235 名患者在 22 个退伍军人事务部血管外科诊所被随机分组。所有患者的 AAA 直径均大于 5.0 厘米,且均为开放修复和 EVAR 的候选者。数据收集于 2017 年 8 月至 2020 年 12 月,数据分析于 2020 年 12 月至 2021 年 6 月进行。

干预措施

使用决策辅助工具进行术前咨询与常规护理。

主要结局和测量指标

主要结局是使用卡方分析、κ 统计量和调整后的优势比衡量患者的偏好与其修复类型之间的一致性的比例。

结果

在纳入的 235 名患者中,234 名(99.6%)为男性,平均(SD)年龄为 73(5.9)岁。共有 126 名患者入组决策辅助组,109 名患者入组对照组。在入组后 2 年内,192 名(81.7%)接受了修复。两组患者在年龄、性别、动脉瘤大小、髂动脉受累和 Charlson 合并症指数评分方面相似。两组患者均更倾向于选择 EVAR 而非开放修复(决策辅助组 122 人中 96 人[79%];对照组 106 人中 81 人[76%];P = .60)。与对照组相比,决策辅助组的患者更有可能接受他们首选的修复类型(95%一致性[98 人中的 93 人]与 86%一致性[94 人中的 81 人];P = .03),且决策辅助组的 κ 统计量更高(κ = 0.78;95%CI,0.60-0.95),对照组的 κ 统计量(κ = 0.53;95%CI,0.32-0.74)。调整后的模型证实了这种关联(决策辅助组与对照组相比,一致性的优势比为 2.93;95%CI,1.10-7.70)。

结论和相关性

接受决策辅助工具的患者更有可能接受他们首选的 AAA 修复类型,这表明决策辅助工具可以帮助更好地将患者的偏好与主要心血管手术中的治疗方法相匹配。

试验注册

ClinicalTrials.gov 标识符:NCT03115346。