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AMPDECIDE截肢水平患者决策辅助工具:一项可行性研究。

AMPDECIDE amputation level patient decision aids: a feasibility study.

作者信息

Henderson Alison W, Soltani Maryam, Suckow Bjoern D, Kern Alison R, Matlock Daniel D, Czerniecki Joseph M, Norvell Daniel C

机构信息

VA Center for Limb Loss and MoBility (CLiMB), 1660 S. Columbian Way, Seattle, WA, 98101, USA.

VA Puget Sound Health Care System, 1660 S. Columbian Way, Seattle, WA, 98101, USA.

出版信息

BMC Med Inform Decis Mak. 2025 Jul 1;25(1):218. doi: 10.1186/s12911-025-03084-7.

DOI:10.1186/s12911-025-03084-7
PMID:40597069
Abstract

OBJECTIVE

This was a feasibility study of the AMPDECIDE amputation level selection patient decision aids (one transmetatarsal vs. transtibial, the other transtibial vs. transfemoral) designed to inform a larger efficacy trial. We intended to gather data about usability of the aids, gather efficacy data about an amputation-level specific knowledge scale, identify any patient-barriers to the use of the decision aids, and evaluate the feasibility of our study methods.

DESIGN

Feasibility study with an uncontrolled before-after design in two medical centers.

METHODS

A convenience sample of dysvascular patients (both pre- and post-amputation) seen by either the vascular or orthopaedic surgery services at each facility were recruited. Enrolled patients completed baseline measures (including amputation level knowledge items). They then reviewed the decision aid with a research coordinator, followed by additional measures of control preference, numeracy, literacy and open-ended questions.

RESULTS

Eleven patients were enrolled (9-post amputation, 2 pre-amputation). Patients rated the decision aids as easy to navigate. Nearly all patients expressed a desire to see their personalized mobility and reamputation risks should they be made available. Patients demonstrated 17% improved amputation level knowledge after exposure to the decision aids. In addition, 81% of patients indicated wanting to participate in the amputation level decision. The study encountered difficulties identifying and recruiting patients until greater clinician involvement was included.

CONCLUSIONS

The AMPDECIDE patient decision aids and the study measures appear well suited for a larger efficacy trial. Patients were able to digest the information supplied in the aids and responded well to them. The initial recruitment strategy was insufficient; greater clinician involvement may help in the future.

CLINICAL TRIAL NUMBER

Not applicable.

TRIAL REGISTRATION

Not applicable.

摘要

目的

这是一项关于AMPDECIDE截肢水平选择患者决策辅助工具(一个是经跖骨截肢与经胫骨截肢对比,另一个是经胫骨截肢与经股骨截肢对比)的可行性研究,旨在为一项更大规模的疗效试验提供依据。我们旨在收集有关这些辅助工具可用性的数据,收集关于截肢水平特定知识量表的疗效数据,确定使用决策辅助工具的任何患者障碍,并评估我们研究方法的可行性。

设计

在两个医疗中心采用非对照前后设计的可行性研究。

方法

招募了在每个机构的血管外科或整形外科就诊的血管性疾病患者(截肢前后)的便利样本。入选患者完成基线测量(包括截肢水平知识项目)。然后他们与研究协调员一起查看决策辅助工具,随后进行关于控制偏好、计算能力、读写能力和开放式问题的额外测量。

结果

招募了11名患者(9名截肢后患者,2名截肢前患者)。患者对决策辅助工具的评价是易于操作。几乎所有患者都表示希望看到如果提供个性化的行动能力和再次截肢风险。接触决策辅助工具后,患者的截肢水平知识提高了17%。此外,81%的患者表示希望参与截肢水平决策。在纳入更多临床医生参与之前,该研究在识别和招募患者方面遇到困难。

结论

AMPDECIDE患者决策辅助工具和研究措施似乎非常适合进行更大规模的疗效试验。患者能够理解辅助工具中提供的信息并对其反应良好。最初的招募策略不足;未来更多临床医生的参与可能会有所帮助。

临床试验编号

不适用。

试验注册

不适用。

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本文引用的文献

1
Development of the AMPDECIDE Decision Aid to Facilitate Shared Decision Making in Patients Facing Amputation Secondary to Chronic Limb Threatening Ischemia.开发 AMPDECIDE 决策辅助工具,以促进面临因慢性肢体威胁性缺血而截肢的患者的共同决策。
J Surg Res. 2024 Jul;299:68-75. doi: 10.1016/j.jss.2024.03.011. Epub 2024 May 6.
2
The Development and Pilot Study of a Multiple Criteria Decision Analysis (MCDA) to Compare Patient and Provider Priorities around Amputation-Level Outcomes.一项用于比较围绕截肢水平结果的患者和提供者优先事项的多标准决策分析(MCDA)的开发与初步研究
MDM Policy Pract. 2022 Dec 15;7(2):23814683221143765. doi: 10.1177/23814683221143765. eCollection 2022 Jul-Dec.
3
Improving Shared Decision Making in Vascular Surgery: A Stepped Wedge Cluster Randomised Trial.
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。
Eur J Vasc Endovasc Surg. 2022 Jul;64(1):73-81. doi: 10.1016/j.ejvs.2022.04.016. Epub 2022 Apr 26.
4
Understanding the experience of veterans who require lower limb amputation in the veterans health administration.了解在退伍军人健康管理局需要进行下肢截肢的退伍军人的体验。
PLoS One. 2022 Mar 18;17(3):e0265620. doi: 10.1371/journal.pone.0265620. eCollection 2022.
5
Addressing Health Literacy in Patient Decision Aids: An Update from the International Patient Decision Aid Standards.解决患者决策辅助工具中的健康素养问题:国际患者决策辅助标准的最新进展。
Med Decis Making. 2021 Oct;41(7):848-869. doi: 10.1177/0272989X211011101. Epub 2021 May 29.
6
Current Challenges When Using Numbers in Patient Decision Aids: Advanced Concepts.当前患者决策辅助工具中使用数字时面临的挑战:高级概念。
Med Decis Making. 2021 Oct;41(7):834-847. doi: 10.1177/0272989X21996342. Epub 2021 Mar 4.
7
Guidance for conducting feasibility and pilot studies for implementation trials.实施试验的可行性和试点研究指南。
Pilot Feasibility Stud. 2020 Oct 31;6(1):167. doi: 10.1186/s40814-020-00634-w.
8
Learning shared decision-making in clinical practice.在临床实践中学习共同决策。
Patient Educ Couns. 2021 May;104(5):1206-1212. doi: 10.1016/j.pec.2020.09.034. Epub 2020 Sep 29.
9
Risks and Risk Factors for Ipsilateral Re-Amputation in the First Year Following First Major Unilateral Dysvascular Amputation.首次单侧血运性坏疽性大截肢术后第一年同侧再截肢的风险和风险因素。
Eur J Vasc Endovasc Surg. 2020 Oct;60(4):614-621. doi: 10.1016/j.ejvs.2020.06.026. Epub 2020 Aug 13.
10
Shared decision making in surgery: a scoping review of patient and surgeon preferences.手术中的共同决策:患者和外科医生偏好的范围综述。
BMC Med Inform Decis Mak. 2020 Aug 12;20(1):190. doi: 10.1186/s12911-020-01211-0.