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在远程医疗支持下,稳定型缺血性心脏病患者的护理从三级医疗向初级医疗的过渡:随机非劣效性临床试验。

Transition of care of stable ischaemic heart disease patients from tertiary to primary care with telemedicine support: Randomized noninferiority clinical trial.

作者信息

Ruschel Karen B, Rados Dimitris Rv, Furtado Mariana V, Batista Joanna d'Arc L, Katz Natan, Harzheim Erno, Polanczyk Carisi A

机构信息

Federal University of Rio Grande do Sul (Universidade Federal do Rio Grande do Sul - UFRGS).

Health Technology Assessment Institute (Instituto de Avaliação de Tecnologia em Saúde - IATS).

出版信息

J Telemed Telecare. 2022 Jan;28(1):52-57. doi: 10.1177/1357633X20906648. Epub 2020 Mar 18.

Abstract

INTRODUCTION

Evidence of telehealth for chronic disease management is scarce and contradictory.

OBJECTIVES

We aimed to evaluate the safety and efficacy of teleconsultations as support in the care transition of patients with stable coronary artery disease (CAD) from tertiary to primary care.

METHODS

A randomized noninferiority clinical trial was undertaken in patients with CAD from a tertiary hospital in a middle-income country. Patients with functional angina class 1 or 2 and meeting discharge criteria were randomized to remain in the cardiology outpatient clinic for 12 months (control group, CG) or continue follow-up in a primary care unit with clinical support via telemedicine (intervention group, IG). The primary outcome was the maintenance of the functional angina class after 12 months. Secondary outcomes included control of risk factors and clinical outcomes.

RESULTS

In total 271 patients (mean age, 66 years) were included; 81.1% and 91% of the IG and CG, respectively, maintained stable angina symptoms, thus noninferiority could not be shown between the groups. Regarding emergency room visits at 1 year, the IG (7.6%) was noninferior to the CG (6.0%) (absolute difference, 1.6%; noninferiority margin (NIM), -4.8% to 8.2%). For control of risk factors, 30.7% and 29.6% of the IG and CG, respectively, had blood pressure <130/80 mmHg (absolute difference, 1.1%; NIM, -10.5% to 12.8%), and 48.9% and 33.3% of diabetic patients in the IG and CG, respectively, had glycated haemoglobin <7% (absolute difference, 15.6%; NIM, -6.8% to 36%).

CONCLUSIONS

In our study, the difference in the patients' angina functional class did not result in greater seeking of emergency care, supporting that discharge from the outpatient clinic with telemedicine is safe for patients with stable CAD treated at the tertiary level. The control of risk factors in these patients was noninferior to patients followed up in primary care. ClinicalTrials.gov (NCT02489565).

摘要

引言

远程医疗用于慢性病管理的证据稀缺且相互矛盾。

目的

我们旨在评估远程会诊作为稳定型冠状动脉疾病(CAD)患者从三级医疗向初级医疗护理过渡的支持手段的安全性和有效性。

方法

在一个中等收入国家的一家三级医院对CAD患者进行了一项随机非劣效性临床试验。功能性心绞痛1级或2级且符合出院标准的患者被随机分为留在心脏病门诊12个月(对照组,CG)或在初级医疗单位通过远程医疗获得临床支持继续随访(干预组,IG)。主要结局是12个月后功能性心绞痛分级的维持情况。次要结局包括危险因素的控制和临床结局。

结果

共纳入271例患者(平均年龄66岁);IG组和CG组分别有81.1%和91%的患者维持稳定的心绞痛症状,因此两组间未显示出非劣效性。关于1年时的急诊就诊情况,IG组(7.6%)不劣于CG组(6.0%)(绝对差异1.6%;非劣效界值(NIM),-4.8%至8.2%)。对于危险因素的控制,IG组和CG组分别有30.7%和29.6%的患者血压<130/80 mmHg(绝对差异1.1%;NIM,-10.5%至12.8%),IG组和CG组分别有48.9%和33.3%的糖尿病患者糖化血红蛋白<7%(绝对差异15.6%;NIM,-6.8%至36%)。

结论

在我们的研究中,患者心绞痛功能分级的差异并未导致更多的急诊就医需求,这支持了对于在三级医疗机构接受治疗的稳定型CAD患者,通过远程医疗从门诊出院对患者是安全的。这些患者的危险因素控制不劣于在初级医疗中接受随访的患者。ClinicalTrials.gov(NCT02489565)。

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