Bjerre Jenny, Rosenkranz Simone Hofman, Christensen Anne Mielke, Schou Morten, Jøns Christian, Gislason Gunnar, Ruwald Anne-Christine
Department of Cardiology, Cardiovascular Research, Copenhagen University Hospital Herlev-Gentofte, Kildegaardsvej 28, 2900, Hellerup, Denmark.
Research and Test Center for Health Technologies, Copenhagen University Hospital, Rigshospitalet-Glostrup, Valdemar Hansens Vej 1-23, 2600, Glostrup, Denmark.
BMC Cardiovasc Disord. 2018 Nov 20;18(1):212. doi: 10.1186/s12872-018-0949-3.
Implantable cardioverter defibrillator (ICD) implantation is associated with driving restrictions which may have profound effects on the patient's life. However, there is limited patient-reported data on the information given about driving restrictions, the adherence to the restrictions, the incidence of arrhythmic symptoms while driving, and the driving restrictions' effect on ICD patients' daily life and quality of life factors. A specific questionnaire was designed to investigate these objectives, intended for use in a nationwide ICD cohort.
The conceptual framework based on literature review and expert opinion was refined in qualitative semi-structured focus group interviews with ten ICD patients. Content validity was pursued through pre-testing, including expert review and 28 cognitive interviews with patients at all ICD implanting centres in Denmark. Finally, the Danish Pacemaker and ICD registry was used to randomly select 50 ICD patients with a first-time implantation between January 1, 2013 and November 30, 2016 for pilot testing, followed by a test-retest on 25 respondents. Test-retest agreement was assessed using kappa statistics or intraclass correlation coefficients.
The pilot test achieved a response rate of 78%, whereof the majority were web-based (69%). Only 49% stated they had been informed about any driving restrictions after ICD implantation, whereas the number was 75% after appropriate ICD shock. Among respondents, 95% had resumed private driving, ranging from 1 to 90 days after ICD implantation. In those informed of a significant (≥ 1 month) driving ban, 55% stated the driving restrictions had impeded with daily life, especially due to limitations in maintaining employment or getting to/from work and 25% admitted they had knowingly been driving during the restricted period. There were six episodes of dizziness or palpitations not necessitating stopping the vehicle. Test-retest demonstrated good agreement of questionnaire items, with 69% of Kappa coefficients above 0.60.
We have developed a comprehensive questionnaire on ICD patients' perspective on driving. Pre-testing and pilot testing demonstrated good content validity, feasible data collection methods, and a robust response rate. Thus, we believe the final questionnaire, distributed to almost 4000 ICD patients, will capture essential evidence to help inform driving guidelines in this population.
植入式心脏复律除颤器（ICD）植入与驾驶限制相关，这可能对患者生活产生深远影响。然而，关于所提供的驾驶限制信息、对限制的遵守情况、驾驶时心律失常症状的发生率以及驾驶限制对ICD患者日常生活和生活质量因素的影响，患者报告的数据有限。设计了一份特定问卷来调查这些目标，旨在用于全国性的ICD队列研究。
基于文献综述和专家意见的概念框架在对10名ICD患者进行的定性半结构化焦点小组访谈中得到完善。通过预测试来追求内容效度，包括专家评审以及在丹麦所有ICD植入中心对患者进行的28次认知访谈。最后，利用丹麦起搏器和ICD登记处随机选取2013年1月1日至2016年11月30日期间首次植入ICD的50名患者进行试点测试，随后对25名受访者进行重测。使用kappa统计量或组内相关系数评估重测一致性。
试点测试的回复率为78%，其中大多数是基于网络的回复（69%）。只有49%的患者表示ICD植入后他们被告知任何驾驶限制，而在适当的ICD电击后这一比例为75%。在受访者中，95%在ICD植入后1至90天恢复了私人驾驶。在被告知有重大（≥1个月）驾驶禁令的患者中，55%表示驾驶限制妨碍了日常生活，特别是由于在维持就业或上下班方面存在限制，25%承认他们在限制期内明知故犯地仍在驾驶。有6次头晕或心悸发作，但无需停车。重测表明问卷项目具有良好的一致性，69%的kappa系数高于0.60。
我们针对ICD患者对驾驶的看法制定了一份综合问卷。预测试和试点测试表明其具有良好的内容效度、可行的数据收集方法以及较高的回复率。因此，我们相信分发给近4000名ICD患者的最终问卷将获取重要证据，以帮助为该人群的驾驶指南提供参考。
