Telemonitoring in patients with heart failure.

Telemonitoring in patients with heart failure.
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DOI:
10.1056/nejmoa1010029
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发表时间:
2010-12-09
期刊:
The New England journal of medicine
影响因子:
--
通讯作者:
Krumholz HM
Krumholz HM
中科院分区:
其他
文献类型:
--
作者:
Chaudhry SI;Mattera JA;Curtis JP;Spertus JA;Herrin J;Lin Z;Phillips CO;Hodshon BV;Cooper LS;Krumholz HM

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小型研究表明,远程监护可能会改善心力衰竭的结局,但其在大型试验中的效果尚未确定。我们随机分配1653名最近因心力衰竭住院的患者接受远程监护(826名患者)或常规护理(827名患者)。远程监护是通过基于电话的交互式语音应答系统完成的,该系统收集有关症状和体重的日常信息,并由患者的临床医生审查。主要终点是在登记后180天内因任何原因再次入院或因任何原因死亡。次要终点包括因心力衰竭住院、住院天数和住院次数。患者的中位年龄为61岁,其中42.0%为女性,39.0%为黑人。远程监护组和常规护理组在主要终点方面没有显著差异,分别为52.3%和51.5%(差异,0.8%;95%可信区间[CI],−为4.0%~5.6%;卡方检验P=0.75.远程监护组49.3%的患者再入院,常规护理组47.4%的患者因任何原因再入院(差值,1.9个百分点;95%可信区间,−3.0~6.7;卡方检验P=0.45)。病死率分别为11.1%和11.4%(−为0.2个百分点;95%CI为−3.3~2.8;卡方检验P=0.88)。在次要终点或到达主要终点或其组成部分的时间方面,两组之间没有显著差异。没有不良反应的报道。在最近因心力衰竭而住院的患者中,远程监护并没有改善结果。这些结果表明,在采用疾病管理战略之前,对其进行彻底、独立的评估具有重要意义。(由国家心肺和血液研究所资助;ClinicalTrials.gov编号,NCT00303212。)
Small studies suggest that telemonitoring may improve heart-failure outcomes, but its effect in a large trial has not been established. We randomly assigned 1653 patients who had recently been hospitalized for heart failure to undergo either telemonitoring (826 patients) or usual care (827 patients). Telemonitoring was accomplished by means of a telephone-based interactive voice-response system that collected daily information about symptoms and weight that was reviewed by the patients’ clinicians. The primary end point was readmission for any reason or death from any cause within 180 days after enrollment. Secondary end points included hospitalization for heart failure, number of days in the hospital, and number of hospitalizations. The median age of the patients was 61 years; 42.0% were female, and 39.0% were black. The telemonitoring group and the usual-care group did not differ significantly with respect to the primary end point, which occurred in 52.3% and 51.5% of patients, respectively (difference, 0.8 percentage points; 95% confidence interval [CI], −4.0 to 5.6; P = 0.75 by the chi-square test). Readmission for any reason occurred in 49.3% of patients in the telemonitoring group and 47.4% of patients in the usual-care group (difference, 1.9 percentage points; 95% CI, −3.0 to 6.7; P = 0.45 by the chi-square test). Death occurred in 11.1% of the telemonitoring group and 11.4% of the usual care group (difference, −0.2 percentage points; 95% CI, −3.3 to 2.8; P = 0.88 by the chi-square test). There were no significant differences between the two groups with respect to the secondary end points or the time to the primary end point or its components. No adverse events were reported. Among patients recently hospitalized for heart failure, telemonitoring did not improve outcomes. The results indicate the importance of a thorough, independent evaluation of disease-management strategies before their adoption. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT00303212.)