Impact of implantable cardioverter-defibrillator recalls on patients' anxiety, depression, and quality of life.
Impact of implantable cardioverter-defibrillator recalls on patients' anxiety, depression, and quality of life.
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植入式心脏复律除颤器召回对患者焦虑、抑郁和生活质量的影响。
DOI：
10.1111/j.1540-8159.2008.01204.x
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发表时间：
2008
期刊：
影响因子：
--
通讯作者：
Mehta,Davendra
中科院分区：
文献类型：
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作者：
Undavia,Manish;Goldstein,NathanE;Cohen,Pilar;Sinthawanarong,Kamoltip;Singson,Magdalena;Bhutani,Divaya;Munson,Tracey;Gomes,JosephAnthony;Fischer,Avi;Mehta,Davendra
背景：在过去的2年中，多家植入式心脏复律除颤器（ICD）制造商因可能发生严重故障甚至患者死亡而召回ICD型号。以前研究这些回忆与患者心理健康之间的关系的研究受到样本量小和相互矛盾的结果的限制。本研究的目的是探讨ICD回忆和患者的焦虑，抑郁和生活quality of life.Methods：患者来自纽约市三级医院的电生理门诊。从器械制造商提供的列表中识别出器械受到召回的患者（病例），从门诊患者的便利样本中抽取对照（植入ICD但未受到召回的患者）。调查工具包括两个经过验证的问卷-医院焦虑和抑郁评分（HADS）和MacNew心脏病健康相关生活质量（QOL）量表。此外，还设计了一系列Likert型量表，以阐明患者对以下领域的担忧：愤怒、信任、希望、对ICD电击的担忧、对死亡的恐惧（FOD）以及医生减少其对ICD召回担忧的能力。采用简单描述性统计和双变量分析（χ 2检验和t检验）对数据进行分析。32例（52%）器械召回的患者选择更换发生器。这两组患者（病例组和对照组）的HADS量表或MacNew QOL量表的平均评分无显著差异。ICD被召回患者（病例）组内的亚组分析显示，与II类召回（产品可能导致暂时或医学可逆的不良健康后果）患者相比，I类召回（产品可能导致严重不良健康后果或死亡的合理可能性）患者的QOL降低（P = 0.01）。病例组和对照组患者都报告对医疗保健系统的信任度降低。然而，总的来说，病人对他们的医生处理召回的方式感到满意。有没有显着的变化，在整体关注的ICD休克或FOD between the two groups.Conclusion：在这项研究中的ICD召回，我们发现没有差异的焦虑，抑郁，或生活质量的水平与ICD受召回的患者表示相比，那些没有。这些发现可能反映了良好的医患沟通，这可能减少了与回忆相关的任何焦虑。
Background:In the past 2 years, multiple implantable cardioverter‐defibrillator (ICD) manufacturers have issued recalls on ICD models due to the potential for serious malfunction and even patient death. Previous studies examining the relationship between these recalls and patients' psychological well‐being have been limited by small sample size and conflicting results. The purpose of this study is to examine the association between ICD recalls and patients' anxiety, depression, and quality of life.Methods:Patients were drawn from an outpatient electrophysiology clinic at a tertiary care hospital in New York City. Patients who had devices subject to a recall (cases) were identified from lists provided by device manufacturer and controls (patients with ICDs not subjected to a recall) were drawn from a convenience sample of outpatients. The survey instrument consisted of two validated questionnaires–‐Hospital Anxiety and Depression Score (HADS) and MacNew heart disease health‐related quality of life (QOL) instrument. In addition, a series of Likert‐type scales were designed to elucidate patients' concerns related to the following domains: anger, trust, hope, concerns regarding ICD shock, fear of death (FOD), and physicians' ability to reduce their concern about the ICD recall. Data were analyzed using simple descriptive statistics and bivariate analyses (χ2and t‐test) as appropriate.Result:Sixty‐one cases and 43 control patients were enrolled. Thirty‐two patients (52%) with devices subject to a recall opted for a generator replacement. There were no significant differences in the mean scores on the HADS scale, or the MacNew QOL scale between these two groups of patients (cases and controls). Subgroup analysis within the group of patients whose ICDs were recalled (cases) revealed a reduced QOL among patients with a class I recall (reasonable probability that the product will cause serious adverse health consequences or death) as compared to those with a class II recall (product may cause temporary or medically reversible adverse health consequences) (P = 0.01). Both cases and control patients reported having reduced trust in the health‐care system. On the whole, however, patients were satisfied with the way their physicians dealt with the recall. There was no significant change in the overall concern of ICD shocks or FOD between the two groups.Conclusion:In this study of ICD recall, we found no difference in the levels of anxiety, depression, or QOL expressed by patients with an ICD subject to a recall as compared to those without. These findings may be a reflection of good physician‐patient communication, which might have reduced any anxiety associated with recalls.