Patient-Reported Safety Events in Chronic Kidney Disease Recorded With an Interactive Voice-Inquiry Dial-Response System: Monthly Report Analysis.
Patient-Reported Safety Events in Chronic Kidney Disease Recorded With an Interactive Voice-Inquiry Dial-Response System: Monthly Report Analysis.
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DOI：
10.2196/jmir.5203
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发表时间：
2016-05-26
影响因子：
7.4
通讯作者：
Zhan M
中科院分区：
文献类型：
--
作者：
Fink JC;Doerfler RM;Yoffe MR;Diamantidis CJ;Blumenthal JB;Siddiqui T;Gardner JF;Snitker S;Zhan M
监测患者报告的结果(PRO)可能会提高慢性肾脏疾病(CKD)患者的安全性。评估交互式语音查询拨号响应系统(IVRDS)在检测临床环境外与CKD相关的不良安全事件方面的性能，并比较使用IVDRS和纸质日记检测的事件发生率。这是一项对安全肾脏护理(SKC)研究中III-V期CKD患者进行的为期6个月的研究。参与者从纸质日记转到IVDRS，记录患者报告的安全事件，定义为可归因于药物或护理的症状或事件。IVDRS改编自SKC纸质日记，用于记录事件频率和补救措施。参与者每周都会被自动呼叫，并被允许自行发起呼叫。两名内科裁判员对月度报告进行了审查，以确定其临床意义。对52名参与者进行了总计1384周的跟踪调查。52名参与者中有28人(54%)报告了使用IVDRS的事件，而使用纸质日记的52人中有8人(15%)报告了事件；低血糖是两种方法最常见的事件。除混淆和皮疹外，所有IVDRS菜单选项都至少被选中一次。121个电话报告了事件，8个电话报告了救护车或急诊室(ER)就诊的事件补救。有无低血糖的IVDRS和纸质日记的发生率分别为26.7比4.7和18.3比0.8/100人周(P=0.002和P<；001)。频繁用户(例如，10个事件)在方法上有很大差异，排除最频繁用户的事件发生率分别为每100人周16.9和2.5(P<；.001)。审判员发现，在80份报告中，大约有一半具有临床意义，约四分之一被认为是可起诉的。低血糖通常与疲劳和跌倒的额外报告有关。与会者对IVDRS表示满意。在CKD患者中使用IVDRS显示了临床显著安全事件的高频率，并有可能被用作临床护理的重要补充，以提高患者的安全性。
Monitoring patient-reported outcomes (PROs) may improve safety of chronic kidney disease (CKD) patients. Evaluate the performance of an interactive voice-inquiry dial-response system (IVRDS) in detecting CKD-pertinent adverse safety events outside of the clinical environment and compare the incidence of events using the IVDRS to that detected by paper diary. This was a 6-month study of Stage III-V CKD patients in the Safe Kidney Care (SKC) study. Participants crossed over from a paper diary to the IVDRS for recording patient-reported safety events defined as symptoms or events attributable to medications or care. The IVDRS was adapted from the SKC paper diary to record event frequency and remediation. Participants were auto-called weekly and permitted to self-initiate calls. Monthly reports were reviewed by two physician adjudicators for their clinical significance. 52 participants were followed over a total of 1384 weeks. 28 out of 52 participants (54%) reported events using the IVDRS versus 8 out of 52 (15%) with the paper diary; hypoglycemia was the most common event for both methods. All IVDRS menu options were selected at least once except for confusion and rash. Events were reported on 121 calls, with 8 calls reporting event remediation by ambulance or emergency room (ER) visit. The event rate with the IVDRS and paper diary, with and without hypoglycemia, was 26.7 versus 4.7 and 18.3 versus 0.8 per 100 person weeks, respectively (P=.002 and P<.001). The frequent users (ie, >10 events) largely differed by method, and event rates excluding the most frequent user of each were 16.9 versus 2.5 per 100 person weeks, respectively (P<.001). Adjudicators found approximately half the 80 reports clinically significant, with about a quarter judged as actionable. Hypoglycemia was often associated with additional reports of fatigue and falling. Participants expressed favorable satisfaction with the IVDRS. Use of the IVDRS among CKD patients reveals a high frequency of clinically significant safety events and has the potential to be used as an important supplement to clinical care for improving patient safety.