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      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

      , MB ChB, MRCP 1 , , MA (Cantab), MB BChir, MRCP 1 , , , BM, MRCP 1 , , BSc (Hons), MBBS, MRCP 1 , , BSc (Hons) 1 , , PhD 1 , , MBBS, DM 2 , , BSc (Hons) 1 , , MSc 1 , 3 , , PhD 3 , , PhD 4 , , MB ChB, PhD 1
      (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      COPD, bronchiectasis, pseudomonas, self-management

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          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.


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


          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.


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


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

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          Most cited references9

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          Microbiologic determinants of exacerbation in chronic obstructive pulmonary disease.

          The culture of bronchial secretions from the lower airway has been reported to be positive for potentially pathogenic microorganisms (PPMs) in patients with stable chronic obstructive pulmonary disease (COPD), but the determinants and effects of this bacterial load in the airway are not established. To determine the bronchial microbial pattern in COPD and its relationship with exacerbation, we pooled analysis of crude data from studies that used protected specimen brush sampling, with age, sex, smoking, lung function, and microbiologic features of the lower airway as independent variables and exacerbation as the outcome, using logistic regression modeling. Of 337 study participants, 70 were healthy, 181 had stable COPD, and 86 had exacerbated COPD. Differences in the microbial characteristics in the participating laboratories were not statistically significant. A cutoff point of 10(2) colony-forming units (CFU) per milliliter or greater for the identification of abnormal positive culture results for PPMs was defined using the 95th percentile in the pooled analysis of healthy individuals. Bronchial colonization of 10(2) CFU/mL or greater by PPMs was found in 53 patients with stable COPD (29%) and in 46 patients with exacerbated COPD (54%) (P<.001, chi(2) test), with a predominance of Haemophilus influenzae and Pseudomonas aeruginosa. Higher microbial loads were associated with exacerbation and showed a statistically significant dose-response relationship after adjustment for covariates (odds ratio, 3.62; 95% confidence interval, 1.47-8.90), but P aeruginosa persisted as a statistically significant risk factor after adjustment for microbial load (odds ratio, 11.12; 95% confidence interval, 1.17-105.82). One quarter of the patients with COPD are colonized by PPMs during their stable periods. Exacerbation is associated with the overgrowth of PPMs and with the appearance of P aeruginosa in the lower airway, which is associated with exacerbation symptoms independent of load.
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            Bacterial infections in patients requiring admission for an acute exacerbation of COPD; a 1-year prospective study.

            To investigate the frequency of respiratory bacterial infections in hospitalized patients, admitted with an acute exacerbation of chronic obstructive pulmonary disease (COPD), to identify the responsible pathogens by sputum culture and to assess patient characteristics in relation to sputum culture results. We prospectively evaluated clinical data and sputum culture results of 171 patients, admitted to the pulmonology department of the University Hospital Maastricht with an acute exacerbation of COPD from 1st January 1999 until 31st December 1999. Eighty-five patients (50%) had positive sputum cultures, indicating the presence of bacterial infection. Pathogens most frequently isolated were: Haemophilus influenzae (45%), Streptococcus pneumoniae (27%), and Pseudomonas aeruginosa (15%). Patients with more severely compromised lung function had a higher incidence of bacterial infections (P = 0.026). There were no significant differences in age, lung function parameters, blood gas results and length of hospital stay between patients with and without bacterial infection. There were no correlations between the type of bacteria isolated and clinical characteristics. Incidence of bacterial infection during acute exacerbations of COPD is about 50%. Patients with and without bacterial infection are not different in clinical characteristics or in outcome parameters. Patients with lower FEV1 have a higher incidence of bacterial infections, but there is no difference in the type of bacterial infection. In the future, the pathogenic role of bacterial infection in exacerbations of COPD should be further investigated, especially the role of bacterial infection in relation to local and systemic inflammation.
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              Pseudomonal infections in patients with COPD: epidemiology and management.

              COPD is a common disease with increasing prevalence. The chronic course of the disease is characterized by acute exacerbations that cause significant worsening of symptoms. Bacterial infections play a dominant role in approximately half of the episodes of acute exacerbations of COPD. The importance of pseudomonal infection in patients with acute exacerbations of COPD stems from its relatively high prevalence in specific subgroups of these patients, and particularly its unique therapeutic ramifications. The colonization rate of Pseudomonas aeruginosa in patients with COPD in a stable condition is low.A review of a large number of clinical series of unselected outpatients with acute exacerbations of COPD revealed that P. aeruginosa was isolated from the patients' sputum at an average rate of 4%. This rate increased significantly in COPD patients with advanced airflow obstruction, in whom the rate of sputum isolates of P. aeruginosa reached 8-13% of all episodes of acute exacerbations of COPD. However, the great majority of bacteria isolated in these patients were not P. aeruginosa, but the three classic bacteria Streptococcus pneumoniae, Hemophilus influenzae, and Moraxella catarrhalis. The subgroup of patients, with acute exacerbations of COPD, with the highest rate of P. aeruginosa infection, which approaches 18% of the episodes, is mechanically ventilated patients. However, even in this subgroup the great majority of bacteria isolated are the above-mentioned three classic pathogens. In light of these epidemiologic data and other important considerations, and in order to achieve optimal antibacterial coverage for the common infectious etiologies, empiric antibacterial therapy should be instituted as follows. Patients with acute exacerbations of COPD with advanced airflow obstruction (FEV(1) <50% of predicted under stable conditions) should receive once daily oral therapy with one of the newer fluoroquinolones, i.e. levofloxacin, moxifloxacin, gatifloxacin, or gemifloxacin for 5-10 days. Patients with severe acute exacerbations of COPD who are receiving mechanical ventilation should receive amikacin in addition to one of the intravenous preparations of the newer fluoroquinolones or monotherapy with cefepime, a carbapenem or piperacillin/tazobactam. In both subgroups it is recommended that sputum cultures be performed before initiation of therapy so that the results can guide further therapy.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                May 2017
                19 May 2017
                : 6
                : 5
                : e89
                [1] 1Department of Research and Innovation Portsmouth Hospitals National Health Service Trust PortsmouthUnited Kingdom
                [2] 2Department of Respiratory Medicine Portsmouth Hospitals National Health Service Trust PortsmouthUnited Kingdom
                [3] 3School of Health Sciences and Social Work University of Portsmouth PortsmouthUnited Kingdom
                [4] 4Aseptika Ltd HuntingdonUnited Kingdom
                Author notes
                Corresponding Author: Thomas L Jones tom.jones@ 123456doctors.org.uk
                Author information
                ©Claire Roberts, Thomas L Jones, Samal Gunatilake, Will Storrar, Scott Elliott, Sharon Glaysher, Ben Green, Steven Rule, Carole Fogg, Ann Dewey, Kevin A Auton, Anoop J Chauhan. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.05.2017.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 23 September 2016
                : 24 November 2016
                : 12 March 2017
                : 20 March 2017

                copd, bronchiectasis, pseudomonas, self-management


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