心力衰竭患者的远程监测。
Telemonitoring in patients with heart failure.
机构信息
Section of General Medicine, Department of Medicine, Yale University School of Medicine, New Haven, CT 06510, USA.
出版信息
N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.
BACKGROUND
Small studies suggest that telemonitoring may improve heart-failure outcomes, but its effect in a large trial has not been established.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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.).
背景
小型研究表明，远程监测可能改善心力衰竭的预后，但它在大型试验中的效果尚未确定。
方法
我们随机分配了 1653 名最近因心力衰竭住院的患者，分别接受远程监测（826 名患者）或常规护理（827 名患者）。远程监测通过基于电话的交互式语音应答系统进行，该系统每天收集有关症状和体重的信息，由患者的临床医生进行审查。主要终点是在登记后 180 天内因任何原因再次入院或任何原因导致的死亡。次要终点包括心力衰竭住院、住院天数和住院次数。
结果
患者的中位年龄为 61 岁；42.0%为女性，39.0%为黑人。远程监测组和常规护理组在主要终点方面无显著差异，分别有 52.3%和 51.5%的患者发生该终点（差异为 0.8 个百分点；95%置信区间[CI]，-4.0 至 5.6；P=0.75，卡方检验）。远程监测组有 49.3%的患者因任何原因再次入院，常规护理组有 47.4%的患者再次入院（差异为 1.9 个百分点；95%CI，-3.0 至 6.7；P=0.45，卡方检验）。远程监测组有 11.1%的患者死亡，常规护理组有 11.4%的患者死亡（差异为-0.2 个百分点；95%CI，-3.3 至 2.8；P=0.88，卡方检验）。两组在次要终点或主要终点及其组成部分的时间方面均无显著差异。没有报告不良事件。
结论
在最近因心力衰竭住院的患者中，远程监测并未改善结局。结果表明，在采用疾病管理策略之前，需要进行彻底、独立的评估。（由美国国立心肺血液研究所资助；临床试验.gov 编号，NCT00303212。）
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