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远程监测在慢性阻塞性肺疾病(CHROMED)中的应用。一项随机临床试验。

Telemonitoring in Chronic Obstructive Pulmonary Disease (CHROMED). A Randomized Clinical Trial.

机构信息

1 University Hospital Aintree, Liverpool, United Kingdom.

2 School of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.

出版信息

Am J Respir Crit Care Med. 2018 Sep 1;198(5):620-628. doi: 10.1164/rccm.201712-2404OC.

Abstract

RATIONALE

Early detection of chronic obstructive pulmonary disease (COPD) exacerbations using telemonitoring of physiological variables might reduce the frequency of hospitalization.

OBJECTIVES

To evaluate the efficacy of home monitoring of lung mechanics by the forced oscillation technique and cardiac parameters in older patients with COPD and comorbidities.

METHODS

This multicenter, randomized clinical trial recruited 312 patients with Global Initiative for Chronic Obstructive Lung Disease grades II to IV COPD (median age, 71 yr [interquartile range, 66-76 yr]; 49.6% grade II, 50.4% grades III-IV), with a history of exacerbation in the previous year and at least one nonpulmonary comorbidity. Patients were randomized to usual care (n = 158) or telemonitoring (n = 154) and followed for 9 months. All telemonitoring patients self-assessed lung mechanics daily, and in a subgroup with congestive heart failure (n = 37) cardiac parameters were also monitored. An algorithm identified deterioration, triggering a telephone contact to determine appropriate interventions.

MEASUREMENTS AND MAIN RESULTS

Primary outcomes were time to first hospitalization (TTFH) and change in the EuroQoL EQ-5D utility index score. Secondary outcomes included: rate of antibiotic/corticosteroid prescription; hospitalization; the COPD Assessment Tool, Patient Health Questionnaire-9, and Minnesota Living with Heart Failure questionnaire scores; quality-adjusted life years; and healthcare costs. Telemonitoring did not affect TTFH, EQ-5D utility index score, antibiotic prescriptions, hospitalization rate, or questionnaire scores. In an exploratory analysis, telemedicine was associated with fewer repeat hospitalizations (-54%; P = 0.017).

CONCLUSIONS

In older patients with COPD and comorbidities, remote monitoring of lung function by forced oscillation technique and cardiac parameters did not change TTFH and EQ-5D. Clinical trial registered with www.clinicaltrials.gov (NCT 01960907).

摘要

背景

通过生理变量的远程监测来早期发现慢性阻塞性肺疾病(COPD)加重,可能会减少住院频率。

目的

评估使用强迫振荡技术和心脏参数对患有 COPD 及合并症的老年患者进行家庭肺部力学和心脏参数监测的效果。

方法

这是一项多中心、随机临床试验,共纳入 312 名患有全球慢性阻塞性肺疾病倡议 II 至 IV 级 COPD(中位年龄 71 岁[四分位间距 66-76 岁];49.6%为 II 级,50.4%为 III-IV 级)且在过去一年中曾有过加重病史和至少一种非肺部合并症的患者。患者被随机分配至常规护理组(n=158)或远程监测组(n=154),并随访 9 个月。所有远程监测患者每日自我评估肺部力学,在充血性心力衰竭亚组(n=37)中还监测心脏参数。一个算法会识别病情恶化,并触发电话联系以确定适当的干预措施。

测量和主要结果

主要结局为首次住院时间(TTFH)和欧洲五维健康量表(EQ-5D)效用指数评分的变化。次要结局包括:抗生素/皮质类固醇处方率;住院率;COPD 评估测试、患者健康问卷-9 及明尼苏达州心力衰竭生活质量问卷评分;质量调整生命年;以及医疗保健费用。远程监测并未影响 TTFH、EQ-5D 效用指数评分、抗生素处方、住院率或问卷评分。在一项探索性分析中,远程医疗与较少的重复住院相关(-54%;P=0.017)。

结论

在患有 COPD 及合并症的老年患者中,通过强迫振荡技术和心脏参数对肺功能进行远程监测并未改变 TTFH 和 EQ-5D。该临床试验已在 www.clinicaltrials.gov 注册(NCT 01960907)。

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