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一项混合方法、随机、对照可行性试验,为设计一项III期试验提供信息,以测试手持风扇对难治性呼吸困难患者身体活动和照护者焦虑的影响。

A Mixed-Methods, Randomized, Controlled Feasibility Trial to Inform the Design of a Phase III Trial to Test the Effect of the Handheld Fan on Physical Activity and Carer Anxiety in Patients With Refractory Breathlessness.

作者信息

Johnson Miriam J, Booth Sara, Currow David C, Lam Lawrence T, Phillips Jane L

机构信息

Palliative Medicine, Hull York Medical School, University of Hull, Hull, United Kingdom.

Department of Oncology, University of Cambridge, Cambridge, United Kingdom.

出版信息

J Pain Symptom Manage. 2016 May;51(5):807-15. doi: 10.1016/j.jpainsymman.2015.11.026. Epub 2016 Feb 12.

Abstract

CONTEXT

The handheld fan is an inexpensive and safe way to provide facial airflow, which may reduce the sensation of chronic refractory breathlessness, a frequently encountered symptom.

OBJECTIVES

To test the feasibility of developing an adequately powered, multicenter, multinational randomized controlled trial comparing the efficacy of a handheld fan and exercise advice with advice alone in increasing activity in people with chronic refractory breathlessness from a variety of medical conditions, measuring recruitment rates; data quality; and potential primary outcome measures.

METHODS

This was a Phase II, multisite, international, parallel, nonblinded, mixed-methods randomized controlled trial. Participants were centrally randomized to fan or control. All received breathlessness self-management/exercise advice and were followed up weekly for four weeks. Participants/carers were invited to participate in a semistructured interview at the study's conclusion.

RESULTS

Ninety-seven people were screened, 49 randomized (mean age 68 years; 49% men), and 43 completed the study. Site recruitment varied from 0.25 to 3.3/month and screening:randomization from 1.1:1 to 8.5:1. There were few missing data except for the Chronic Obstructive Pulmonary Disease Self-Efficacy Scale (two-thirds of data missing). No harms were observed. Three interview themes included 1) a fan is a helpful self-management strategy, 2) a fan aids recovery, and 3) a symptom control trial was welcome.

CONCLUSION

A definitive, multisite trial to study the use of the handheld fan as part of self-management of chronic refractory breathlessness is feasible. Participants found the fan useful. However, the value of information for changing practice or policy is unlikely to justify the expense of such a trial, given perceived benefits, the minimal costs, and an absence of harms demonstrated in this study.

摘要

背景

手持风扇是一种提供面部气流的廉价且安全的方式,这可能会减轻慢性难治性呼吸困难的感觉,这是一种常见症状。

目的

测试开展一项有足够效力的多中心、跨国随机对照试验的可行性,该试验比较手持风扇和运动建议与仅给予建议相比,对患有各种疾病的慢性难治性呼吸困难患者增加活动量的疗效,测量招募率、数据质量和潜在的主要结局指标。

方法

这是一项II期、多地点、国际性、平行、非盲、混合方法的随机对照试验。参与者被集中随机分配到风扇组或对照组。所有人都接受了呼吸困难自我管理/运动建议,并每周随访四周。在研究结束时,邀请参与者/护理人员参加半结构化访谈。

结果

筛查了97人,49人被随机分组(平均年龄68岁;49%为男性),43人完成了研究。各研究地点的招募人数从每月0.25人至3.3人不等,筛查与随机分组的比例从1.1:1至8.5:1。除慢性阻塞性肺疾病自我效能量表外(三分之二的数据缺失),几乎没有缺失数据。未观察到不良事件。访谈的三个主题包括:1)风扇是一种有用的自我管理策略;2)风扇有助于恢复;3)症状控制试验受到欢迎。

结论

开展一项确定性的多地点试验来研究将手持风扇作为慢性难治性呼吸困难自我管理的一部分是可行的。参与者发现风扇很有用。然而,鉴于本研究中显示的预期益处、最低成本和无不良事件,用于改变实践或政策的信息价值不太可能证明进行此类试验的费用是合理的。

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