Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial.

Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial.
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远程监控在医院入院中纳入现有临床服务的有效性,以加剧慢性阻塞性肺部疾病:研究人员盲目,多中心,随机对照试验。

DOI:
10.1136/bmj.f6070
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发表时间:
2013-10-17
期刊:
BMJ (Clinical research ed.)
影响因子:
--
通讯作者:
McKinstry B
McKinstry B
中科院分区:
其他
文献类型:
--
作者:
Pinnock H;Hanley J;McCloughan L;Todd A;Krishan A;Lewis S;Stoddart A;van der Pol M;MacNee W;Sheikh A;Pagliari C;McKinstry B

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目的测试远程监护整合到现有的临床服务,使干预组和对照组有机会获得相同的临床护理的有效性。设计研究者盲法、多中心、随机对照试验。设置英国初级保健(洛锡安,苏格兰)。参与者在随机化前一年至少有一次慢性阻塞性肺疾病(COPD)入院的成年人。我们排除了患有其他重大肺部疾病的人,无法提供知情同意书或完成研究的人,或有其他重大社会或临床问题的人。参与者于2009年5月21日至2011年3月28日期间招募,并集中随机接受远程监护或常规自我监测。使用触摸屏,远程监测参与者记录了有关症状和治疗使用的每日问卷,并使用连接的仪器监测血氧饱和度。如果读数被忽略或超过阈值,则基于症状评分的算法会生成警报。两组患者都从现有的临床服务机构接受了类似的护理。主要结局指标主要结局是随机分组后1年内因COPD急性加重而入院的时间。其他结果包括入院人数和持续时间,以及健康相关生活质量(使用St乔治呼吸问卷(SGRQ))、焦虑或抑郁(或两者)、自我效能、知识和治疗依从性的有效问卷评估。分析意向treat. Results完成研究的256例患者中,128例患者随机接受远程监护,128例接受常规护理;各组的基线特征相似。两组之间入院天数无显著差异(校正风险比0.98,95%置信区间0.66 - 1.44)。一年多来,两组的平均COPD入院人数相似(远程监测组每人1.2例入院(标准差1.9)与对照组1.1例入院(1.6); P=0.59)。两组间COPD住院一年以上的平均持续时间也相似(每人9.5天(标准差19.1)vs 8.8天(15.9); P=0.88)。干预对组间SGRQ评分无显著影响(68.2(标准差16.3)v67.3(17.3);校正均值差1.39(95%置信区间-1.57至4.35)),或对其他问卷结果无显著影响。 结论:在有COPD急性加重入院史的参与者中,远程监护不能有效推迟入院,也不能改善生活质量。在以前的试验中看到的远程监护的积极作用可能是由于加强了基础临床服务,而不是远程监护通信。 试验注册ISRCTN 96634935。资金:该试验由苏格兰政府首席科学家办公室的NHS应用研究计划资助(ARPG/07/03)。资助者在研究设计、数据的收集、分析和解释、文章的撰写以及提交出版的决定中没有任何作用。NHS Lothian支持远程监护服务和临床服务。
Objective To test the effectiveness of telemonitoring integrated into existing clinical services such that intervention and control groups have access to the same clinical care. Design Researcher blind, multicentre, randomised controlled trial. Setting UK primary care (Lothian, Scotland). Participants Adults with at least one admission for chronic obstructive pulmonary disease (COPD) in the year before randomisation. We excluded people who had other significant lung disease, who were unable to provide informed consent or complete the study, or who had other significant social or clinical problems. Interventions Participants were recruited between 21 May 2009 and 28 March 2011, and centrally randomised to receive telemonitoring or conventional self monitoring. Using a touch screen, telemonitoring participants recorded a daily questionnaire about symptoms and treatment use, and monitored oxygen saturation using linked instruments. Algorithms, based on the symptom score, generated alerts if readings were omitted or breached thresholds. Both groups received similar care from existing clinical services. Main outcome measures The primary outcome was time to hospital admission due to COPD exacerbation up to one year after randomisation. Other outcomes included number and duration of admissions, and validated questionnaire assessments of health related quality of life (using St George’s respiratory questionnaire (SGRQ)), anxiety or depression (or both), self efficacy, knowledge, and adherence to treatment. Analysis was intention to treat. Results Of 256 patients completing the study, 128 patients were randomised to telemonitoring and 128 to usual care; baseline characteristics of each group were similar. The number of days to admission did not differ significantly between groups (adjusted hazard ratio 0.98, 95% confidence interval 0.66 to 1.44). Over one year, the mean number of COPD admissions was similar in both groups (telemonitoring 1.2 admissions per person (standard deviation 1.9) v control 1.1 (1.6); P=0.59). Mean duration of COPD admissions over one year was also similar between groups (9.5 days per person (standard deviation 19.1) v 8.8 days (15.9); P=0.88). The intervention had no significant effect on SGRQ scores between groups (68.2 (standard deviation 16.3) v 67.3 (17.3); adjusted mean difference 1.39 (95% confidence interval −1.57 to 4.35)), or on other questionnaire outcomes. Conclusions In participants with a history of admission for exacerbations of COPD, telemonitoring was not effective in postponing admissions and did not improve quality of life. The positive effect of telemonitoring seen in previous trials could be due to enhancement of the underpinning clinical service rather than the telemonitoring communication. Trial registration ISRCTN96634935. Funding: The trial was funded by an NHS applied research programme grant from the Chief Scientist Office of the Scottish government (ARPG/07/03). The funder had no role in study design and the collection, analysis, and interpretation of data and the writing of the article and the decision to submit it for publication. NHS Lothian supported the telemonitoring service and the clinical services.
DOI: 10.4104/pcrj.2012.00068
发表时间: 2012-09-01
影响因子: --
作者:
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通讯作者: McKinstry, Brian
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发表时间: 2012-12-15
期刊: LANCET
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发表时间: 2010-10-20
影响因子: 3.1
作者:
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