SENSOR研究：一项混合方法研究的方案，该研究旨在通过自我管理检查来预测长期呼吸疾病患者铜绿假单胞菌的病情恶化。

The SENSOR Study: Protocol for a Mixed-Methods Study of Self-Management Checks to Predict Exacerbations of Pseudomonas Aeruginosa in Patients with Long-Term Respiratory Conditions.

作者信息

Roberts Claire, Jones Thomas L, Gunatilake Samal, Storrar Will, Elliott Scott, Glaysher Sharon, Green Ben, Rule Steven, Fogg Carole, Dewey Ann, Auton Kevin A, Chauhan Anoop J

机构信息

Department of Research and Innovation, Portsmouth Hospitals National Health Service Trust, Portsmouth, United Kingdom.

Department of Respiratory Medicine, Portsmouth Hospitals National Health Service Trust, Portsmouth, United Kingdom.

出版信息

JMIR Res Protoc. 2017 May 19;6(5):e89. doi: 10.2196/resprot.6636.

DOI:10.2196/resprot.6636

PMID:28526665

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5457528/

Abstract

BACKGROUND

There are an estimated three million people in the United Kingdom with chronic obstructive pulmonary disease (COPD), and the incidence of bronchiectasis is estimated at around 0.1% but is more common in COPD and severe asthma. Both COPD and bronchiectasis are characterized by exacerbations in which bacteria play a central role. Pseudomonas aeruginosa is isolated from sputum samples from 4% to 15% of adults with COPD and is more likely to be isolated from patients with severe disease. Earlier detection of exacerbations may improve morbidity and mortality by expediting treatment. Aseptika Ltd has developed a system for patients to self-monitor important physiological measurements including levels of physical activity, peak flow, forced expiratory volume (FEV1), and biomarkers for P aeruginosa in sputum.

OBJECTIVE

We aim to test this system in 20 participants with P aeruginosa colonization and 10 controls with Haemophilus influenzae.

METHODS

We plan to recruit 30 adult participants with COPD or non-CF bronchiectasis who have cultured P aeruginosa or H influenzae during an exacerbation in the last 6 months. They must produce sputum on most days and should have been stable for 4 weeks prior to entry. Daily data collected will include symptoms, health care usage, medication, weight, FEV1, physical activity level, blood pressure, oxygen saturation, and temperature. Sputum and urine samples will be provided daily. These data will be analyzed to assess predictive value in detecting upcoming exacerbations. Qualitative data will be gathered through self-administered questionnaires and semistructured interviews to gather information on participant coping and their use of the technology involved.

RESULTS

Recruitment has been completed and results from the study should be available at the end of 2017.

CONCLUSIONS

The SENSOR study aims to test a home-monitoring system in people with chronic airway infection and is currently underway.

摘要

背景

据估计，英国有300万人患有慢性阻塞性肺疾病（COPD），支气管扩张症的发病率估计约为0.1%，但在COPD和重度哮喘患者中更为常见。COPD和支气管扩张症都具有病情加重的特点，其中细菌起着核心作用。从4%至15%的成年COPD患者的痰液样本中可分离出铜绿假单胞菌，且在重症患者中更易分离出该菌。更早地检测到病情加重情况，可能通过加快治疗来改善发病率和死亡率。Aseptika有限公司已开发出一种系统，供患者自我监测重要的生理指标，包括身体活动水平、峰值流速、用力呼气量（FEV1）以及痰液中铜绿假单胞菌的生物标志物。

目的

我们旨在对20名铜绿假单胞菌定植患者和10名流感嗜血杆菌感染对照者进行该系统测试。

方法

我们计划招募30名患有COPD或非囊性纤维化支气管扩张症的成年患者，这些患者在过去6个月内病情加重期间培养出了铜绿假单胞菌或流感嗜血杆菌。他们必须在大多数日子里咳出痰液，且在入组前应已稳定4周。每天收集的数据将包括症状、医疗保健使用情况、药物治疗、体重、FEV1、身体活动水平、血压、血氧饱和度和体温。每天都要提供痰液和尿液样本。将对这些数据进行分析，以评估其在检测即将到来的病情加重方面的预测价值。将通过自我管理问卷和半结构化访谈收集定性数据，以获取有关参与者应对方式及其对所涉及技术使用情况的信息。