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人工耳蜗植入者个性化远程长期随访的可行性:一项随机对照试验

Feasibility of personalised remote long-term follow-up of people with cochlear implants: a randomised controlled trial.

作者信息

Cullington Helen, Kitterick Padraig, Weal Mark, Margol-Gromada Magdalena

机构信息

University of Southampton Auditory Implant Service, Southampton, UK.

National Institute for Health Research Nottingham Hearing Biomedical Research Unit, Nottingham, UK.

出版信息

BMJ Open. 2018 Apr 20;8(4):e019640. doi: 10.1136/bmjopen-2017-019640.

DOI:10.1136/bmjopen-2017-019640
PMID:29678970
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5914764/
Abstract

INTRODUCTION

Substantial resources are required to provide lifelong postoperative care to people with cochlear implants. Most patients visit the clinic annually. We introduced a person-centred remote follow-up pathway, giving patients telemedicine tools to use at home so they would only visit the centre when intervention was required.

OBJECTIVES

To assess the feasibility of comparing a remote care pathway with the standard pathway in adults using cochlear implants.

DESIGN

Two-arm randomised controlled trial. Randomisation used a minimisation approach, controlling for potential confounding factors. Participant blinding was not possible, but baseline measures occurred before allocation.

SETTING

University of Southampton Auditory Implant Service: provider of National Health Service care.

PARTICIPANTS

60 adults who had used cochlear implants for at least 6 months.

INTERVENTIONS

Control group (n=30) followed usual care pathway.Remote care group (n=30) received care remotely for 6 months incorporating: home hearing in noise test, online support tool and self-adjustment of device (only 10 had compatible equipment).

MAIN OUTCOME MEASURES

Primary: change in patient activation; measured using the Patient Activation Measure.Secondary: change in hearing and quality of life; qualitative feedback from patients and clinicians.

RESULTS

One participant in the remote care group dropped out. The remote care group showed a greater increase in patient activation than the control group. Changes in hearing differed between the groups. The remote care group improved on the Triple Digit Test hearing test; the control group perceived their hearing was worse on the Speech, Spatial and Qualities of Hearing Scale questionnaire. Quality of life remained unchanged in both groups. Patients and clinicians were generally positive about remote care tools and wanted to continue.

CONCLUSIONS

Adults with cochlear implants were willing to be randomised and complied with the protocol. Personalised remote care for long-term follow-up is feasible and acceptable, leading to more empowered patients.

TRIAL REGISTRATION NUMBER

ISRCTN14644286.

摘要

引言

为接受人工耳蜗植入的患者提供终身术后护理需要大量资源。大多数患者每年前往诊所就诊。我们引入了以患者为中心的远程随访途径,为患者提供在家中使用的远程医疗工具,以便他们仅在需要干预时才前往中心就诊。

目的

评估在使用人工耳蜗的成人中比较远程护理途径与标准途径的可行性。

设计

双臂随机对照试验。随机分组采用最小化法,控制潜在的混杂因素。无法对参与者进行盲法,但基线测量在分配之前进行。

地点

南安普敦大学听觉植入服务中心:国民健康服务的提供者。

参与者

60名使用人工耳蜗至少6个月的成年人。

干预措施

对照组(n = 30)遵循常规护理途径。远程护理组(n = 30)接受6个月的远程护理,包括:家庭噪声环境听力测试、在线支持工具和设备自我调整(只有10人有兼容设备)。

主要结局指标

主要指标:患者激活度的变化;使用患者激活量表进行测量。次要指标:听力和生活质量的变化;患者和临床医生的定性反馈。

结果

远程护理组有1名参与者退出。远程护理组的患者激活度增加幅度大于对照组。两组的听力变化有所不同。远程护理组在三位数测试听力测试中有所改善;对照组在听力言语、空间和质量量表问卷中感觉自己的听力更差。两组的生活质量均保持不变。患者和临床医生对远程护理工具总体持积极态度,并希望继续使用。

结论

接受人工耳蜗植入的成年人愿意被随机分组并遵守方案。长期随访的个性化远程护理是可行且可接受的,能使患者更有自主权。

试验注册号

ISRCTN14644286。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/29d1/5914764/6ef077646ca2/bmjopen-2017-019640f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/29d1/5914764/803158bad787/bmjopen-2017-019640f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/29d1/5914764/8882a02344dc/bmjopen-2017-019640f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/29d1/5914764/6ef077646ca2/bmjopen-2017-019640f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/29d1/5914764/803158bad787/bmjopen-2017-019640f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/29d1/5914764/8882a02344dc/bmjopen-2017-019640f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/29d1/5914764/6ef077646ca2/bmjopen-2017-019640f03.jpg

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