设备特异性生活质量:ATLAS 试验--在适当受试者中避免使用经静脉导联--的结果

IF 2.9 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS European Journal of Cardiovascular Nursing Pub Date : 2024-04-29 DOI:10.1093/eurjcn/zvae067
Sandra L Carroll, Blandine Mondésert, Andrew D Krahn, Jamil G Bashir, Kathryn Fisher, Kalpana Nair, Jeff S Healey
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引用次数: 0

摘要

目的 患者报告结果(PROs)为了解患者对医疗设备的接受程度提供了重要依据。ATLAS 是一项随机、多中心、开放标签临床试验,最近报告称与 TV-ICD 相比,S-ICD 患者的围手术期并发症更少。本研究报告了 ATLAS 试验的 PROs,包括设备特异性和一般生活质量 (QOL)。方法和结果 设备特异性 QOL 是植入后 1 个月和 6 个月佛罗里达患者接受度调查 (FPAS) 的主要 PRO。次要结果包括植入前和植入后 6 个月使用医疗结果调查 (SF-36) 得出的一般 QOL。FPAS 和 SF-36 采用方差分析。采用描述性统计和混合效应线性模型(MLM)对1个月和6个月时的疼痛、麻醉剂、体重指数和内/间差异进行了分析。在ATLAS随机抽取的503名患者中,有404名患者拥有完整的FPAS数据,可纳入本次分析。参与者的特征是均衡的。在不同时间点,S-ICD 和 TV-ICD 在 FPAS 或 SF-36 方面没有明显差异。S-ICD 和 TV-ICD 的 FPAS 平均总分分别从 73.73 (16.09) 增加到 77.05 (16.13),74.43 (15.35) 增加到 78.25 (15.88)(pamp &;lt;0.001)。PROs表明,两种设备都具有良好的QOL。结论 S-ICD 组和 TV-ICD 组在植入后 6 个月内的设备特异性 QOL 和一般 QOL 相似,表明无论设备类型如何,两组 ATLAS 患者均报告了良好的设备特异性 QOL。S-ICD 患者在植入时的疼痛评分较高,但在 6 个月后疼痛有所减轻。研究结果为共同决策提供了证据。将患者伙伴纳入 ATLAS 为测量患者认为重要的 PROs 提供了机会。注册 ClinialTrials.gov # NCT02881255
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Device-specific quality of life: Results from the ATLAS trial—Avoid Transvenous Leads in Appropriate Subjects
Aim Patient reported outcomes (PROs) provide important insights into patients’ acceptance of their medical devices. ATLAS, a randomized, multi-center, open-label clinical trial, recently reported fewer perioperative complications in S-ICD compared to TV-ICD patients. This study reports PROs, including device-specific and generic quality of life (QOL) from the ATLAS trial. Methods and results Device-specific QOL was the primary PRO using the Florida Patient Acceptance Survey (FPAS) at 1-and 6-months post-implantation. Secondary outcomes included generic QOL using the Medical Outcomes Survey (SF-36) pre-implant and 6-months post-implantation. FPAS and SF-36 were analyzed using ANCOVA. Pain measured using a Numeric Rating Scale, at 1-and 6-months, anesthetic, BMI and within/between differences were analyzed using descriptive statistics and mixed-effects linear models (MLM). Of the 503 patients randomized in ATLAS, 404 had complete FPAS data to include in this analysis. Participant characteristics were balanced. There were no significant differences between S-ICD and TV-ICD for FPAS or SF-36, across timepoints. Mean total FPAS scores increased from 73.73 (16.09) to 77.05 (16.13) and 74.43 (15.35) to 78.25 (15.88) for S-ICD and TV-ICD, respectively, (p <0.001). PROs suggested that both devices were associated with good QOL. Conclusion Device-specific and generic QOL were similar between S-ICD and TV-ICD groups up to 6-months post-implantation indicating that regardless of device type, both groups reported good device specific QOL in ATLAS patients. S-ICD patients reported higher pain scores at implant, but pain decreased by 6 months. The findings offer evidence that can be included during shared decision-making. The inclusion of patient partners in ATLAS provided opportunity to measure PROs that were deemed important to patients. Registration ClinialTrials.gov # NCT02881255
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来源期刊
European Journal of Cardiovascular Nursing
European Journal of Cardiovascular Nursing CARDIAC & CARDIOVASCULAR SYSTEMS-NURSING
CiteScore
5.10
自引率
10.30%
发文量
247
审稿时长
6-12 weeks
期刊介绍: The peer-reviewed journal of the European Society of Cardiology’s Council on Cardiovascular Nursing and Allied Professions (CCNAP) covering the broad field of cardiovascular nursing including chronic and acute care, cardiac rehabilitation, primary and secondary prevention, heart failure, acute coronary syndromes, interventional cardiology, cardiac care, and vascular nursing.
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