Domiciliary monitoring to predict exacerbations of COPD

Introduction: Chronic Obstructive Pulmonary Disease (COPD) is a common, longterm condition that is usually caused by cigarette smoking. In addition to daily symptoms and limitation in activities, patients are prone to chest infections ('exacerbations'). These are a significant problem: unpleasant for patients, and sometimes severe enough to cause hospital admission and death. Reducing the impact of exacerbations is very important. Previous studies have shown that earlier treatment of exacerbations results in faster recovery, and reduced risk of hospital admission. Helping patients to better detect exacerbations early is therefore important. This PhD focuses on measuring overnight heart rate and oxygen saturation, which we hypothesised would provide the best chance of detecting COPD exacerbations earlier than changes in symptoms. // Aim: To evaluate the potential of monitoring physiological variables to provide earlier detection of exacerbations of COPD. // Methods: Firstly, a systematic review was conducted to assess the existing literature on predicting exacerbations of COPD by monitoring physiological variables. Next, two clinical tele-health datasets were accessed, from two different NHS services in London, to report the impact of false alarms on tele-health service, and to examine the feasibility of using downloadable data from home non-invasive ventilation to detect exacerbations resulting in hospitalisation. National and international surveys were conducted to explore the techniques that have been used by healthcare providers on how to customise tele-health alarm limits for each individual, and to explore healthcare providers’ perceptions of tele-health for COPD. These preliminary projects enabled me to formulate my research question and main PhD hypothesis, tested using a prospective randomised controlled trial. Patients were randomised into two groups (one measured physiology only in the morning versus overnight continuous measurement) and patients were monitored for up to six months or the first exacerbation, whichever was sooner. Patients’ acceptance of continuous overnight monitoring was assessed at the end of the study. // Results: Existing studies that used physiological variables were small and heterogeneous using different variables and different protocols. The majority of medical alarms received by tele-health teams are false. Most patients reported a positive acceptance of being monitored overnight. Continuous overnight monitoring identified changes at exacerbation earlier than once-daily monitoring, and earlier than symptoms. Changes in physiological variables were correlated with changes in symptoms during non-stable phases. There is widespread UK national and international use of tele-health monitoring physiological variables in COPD without sufficient evidence base. // Conclusion: Monitoring physiological parameters may be useful in assisting earlier detection of COPD exacerbations but further, robust studies are required to confirm this. A particular challenge is how to set alarm limits for individual patients given the heterogeneity inherent in COPD and COPD exacerbations

Devices and Data Workflow in COPD Wearable Remote Patient Monitoring: A Systematic Review

Background: With global increase in Chronic Obstructive Pulmonary Disease (COPD) prevalence and mortality rates, and socioeconomical burden continuing to rise, current disease management strategies appear inadequate, paving the way for technological solutions, namely remote patient monitoring (RPM), adoption considering its acute disease events management benefit. One RPM’s category stands out, wearable devices, due to its availability and apparent ease of use. Objectives: To assess the current market and interventional solutions regarding wearable devices in the remote monitoring of COPD patients through a systematic review design from a device composition, data workflow, and collected parameters description standpoint. Methods: A systematic review was conducted to identify wearable device trends in this population through the development of a comprehensive search strategy, searching beyond the mainstream databases, and aggregating diverse information found regarding the same device. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines were followed, and quality appraisal of identified studies was performed using the Critical Appraisal Skills Programme (CASP) quality appraisal checklists. Results: The review resulted on the identification of 1590 references, of which a final 79 were included. 56 wearable devices were analysed, with the slight majority belonging to the wellness devices class. Substantial device heterogeneity was identified regarding device composition type and wearing location, and data workflow regarding 4 considered components. Clinical monitoring devices are starting to gain relevance in the market and slightly over a third, aim to assist COPD patients and healthcare professionals in exacerbation prediction. Compliance with validated recommendations is still lacking, with no devices assessing the totality of recommended vital signs. Conclusions: The identified heterogeneity, despite expected considering the relative novelty of wearable devices, alerts for the need to regulate the development and research of these technologies, specially from a structural and data collection and transmission standpoints.Introdução: Com o aumento global das taxas de prevalência e mortalidade da Doença Pulmonar Obstrutiva Crónica (DPOC) e o seu impacto socioeconómico, as atuais estratégias de gestão da doença parecem inadequadas, abrindo caminho para soluções tecnológicas, nomeadamente para a adoção da monitorização remota, tendo em conta o seu benefício na gestão de exacerbações de doenças crónicas. Dentro destaca-se uma categoria, os dispositivos wearable, pela sua disponibilidade e aparente facilidade de uso. Objetivos: Avaliar as soluções existentes, tanto no mercado, como na área de investigação, relativas a dispositivos wearable utilizados na monitorização remota de pacientes com DPOC através de uma revisão sistemática, do ponto de vista da composição do dispositivo, fluxo de dados e descrição dos parâmetros coletados. Métodos: Uma revisão sistemática foi realizada para identificar tendências destes dispositivos, através do desenvolvimento de uma estratégia de pesquisa abrangente, procurando pesquisar para além das databases convencionais e agregar diversas informações encontradas sobre o mesmo dispositivo. Para tal, foram seguidas as diretrizes PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses), e a avaliação da qualidade dos estudos identificados foi realizada utilizando a ferramenta CASP (Critical Appraisal Skills Programme). Resultados: A revisão resultou na identificação de 1590 referências, das quais 79 foram incluídas. Foram analisados 56 dispositivos wearable, com a ligeira maioria a pertencer à classe de dispositivos de wellness. Foi identificada heterogeneidade substancial nos dispositivos em relação à sua composição, local de uso e ao fluxo de dados em relação a 4 componentes considerados. Os dispositivos de monitorização clínica já evidenciam alguma relevância no mercado e, pouco mais de um terço, visam auxiliar pacientes com DPOC e profissionais de saúde na previsão de exacerbações. Ainda assim, é notória a falta do cumprimento das recomendações validadas, não estando disponíveis dispositivos que avaliem a totalidade dos sinais vitais recomendados. Conclusão: A heterogeneidade identificada, apesar de esperada face à relativa novidade dos dispositivos wearable, alerta para a necessidade de regulamentação do desenvolvimento e investigação destas tecnologias, especialmente do ponto de vista estrutural e de recolha e transmissão de dados

Home monitoring of physiology and symptoms to detect Interstitial Lung Disease exacerbations and progression: a systematic review

BACKGROUND: Acute exacerbations and disease progression in interstitial lung disease (AE-ILD) pose important challenges to clinicians and patients. AE-ILD are variable in presentation but may result in rapid progression of ILD, respiratory failure and death. However, in many cases AE-ILD may go unrecognised so that their true impact and response to therapy is unknown. The potential for home monitoring to facilitate early, and accurate, identification of AE and/or ILD progression has gained interest. With increasing evidence available, there is a need for a systematic review on home monitoring of patients with ILD to summarise the existing data. AIMS: To systematically evaluate the evidence for use of home monitoring for early detection of exacerbations and/or progression of ILD. METHOD: We searched Ovid-EMBASE, MEDLINE, and CINAHL using MeSH terms in accordance with the PRISMA guidelines. PROSPERO registration number (CRD42020215166). RESULTS: Thirteen studies comprising 968 patients have demonstrated that home monitoring is feasible and of potential benefit in patients with ILD. Nine studies reported that mean adherence to home monitoring was greater than 75%, and where spirometry was performed there was a significant correlation (r=0.72–0.98, p<0.001) between home and hospital-based readings. Two studies suggested that home monitoring of Forced Vital Capacity (FVC) might facilitate detection of progression in idiopathic pulmonary fibrosis (IPF). CONCLUSION: Despite the fact that individual studies in this systematic review provide supportive evidence suggesting the feasibility and utility of home monitoring in ILD, further studies are necessary to quantify the potential of home monitoring to detect disease progression and/or acute exacerbations

Application of receiver operating characteristic analysis to a remote monitoring model for chronic obstructive pulmonary disease to determine utility and predictive value

This thesis was submitted for the degree of doctor of Philosophy and awarded by Brunel UniversityThis is a foundational study that applies Receiver Operating Characteristic (ROC) analysis to the evaluation of a chronic disease model that utilizes Remote Monitoring (RM) devices to identify clinical deterioration in a Chronic Obstructive Pulmonary Disease (COPD) population. Background: RM programmes in Disease Management (DM) are proliferating as one strategy to address management of chronic disease. The need to validate and quantify evidence-based value is acute. There is a need to apply new methods to better evaluate automated RM systems. ROC analysis is an engineering approach that has been widely applied to medical programmes but has not been applied to RM systems. Evaluation of classifiers, determination of thresholds and predictive accuracy for RM systems have not been evaluated using ROC analysis. Objectives: (1) apply ROC analysis to evaluation of a RM system; (2) analyse the performance of the model when applied to patient outcomes for a COPD population; (3) identify predictive classifier(s); (4) identify optimal threshold(s) and the predictive capacity of the classifiers. Methods: Parametric and non-parametric methods are utilized to determine accuracy, sensitivity, specificity and predictive capacity of classifiers Saturated Peripheral Oxygen (SpO2), Blood Pressure (BP), Pulse Rate (PR) based on event-based patient outcomes that include hospitalisation (IP), accident & emergency (A&E) and home visits (HH). Population: Patients identified with a primary diagnosis of COPD, monitored for a minimum of 183 days with at least one episode of in-patient (IP) hospitalisation for COPD in the 12 months preceding the monitoring period. Data Source: A subset of retrospective de-identified patient data from an NHS Direct evaluation of a COPD RM programme. Subsets utilized include classifiers, biometric readings, alerts generated by the system and resource utilisation. Contribution: Validates ROC methodology, identifies classifier performance and optimal threshold settings for the classifier, while making design recommendations and putting forth the next steps for research. The question answered by this research is that ROC analysis can provide additional information on the predictive capacity of RM systems. Justification of benefit: The results can be applied when evaluating health services and planning decisions on the costs and benefits. Methods can be applied to system design, protocol development, work flows and commissioning decisions based on value and benefit. Conclusion: Results validate the use of ROC analysis as a robust methodology for DM programmes that use RM devices to evaluate classifiers, thresholds and identification of the predictive capacity as well as identify areas where additional design may improve the predictive capacity of the model.

A Chronic Obstructive Pulmonary Disease Pilot Using Risk Stratification to Improve Resource Allocation and Reduce Readmissions

Background: Chronic Obstructive Pulmonary Disease (COPD) impacts 250 million people, is associated with high hospital readmission rates, and costs over $50 billion annually. Purpose: Apply risk stratification identifying higher risk patients to prioritize complex, time-consuming interventions and resources. Methods: Patients hospitalized with COPD were risk stratified using PEARL. Moderate-high risk patients were referred to specialty nurse practitioners, who used real-time interventions and motivational interviewing during intense weekly visits over 30 days targeting self-management, patient-specific risks, and resources. Results: No patients were readmitted or died during the pilot using risk stratification with patient-specific tertiary preventive care to communicate resource allocation. Impact: This process provided recommendations for expansion throughout the healthcare facility, other chronic health conditions, budgets and policy for value-based care, and further research

A case series of an off-the-shelf online health resource with integrated nurse coaching to support self-management in COPD

Background: COPD has significant psychosocial impact. Self-management support improves quality of life, but programs are not universally available. IT-based self-management interventions can provide home-based support, but have mixed results. We conducted a case series of an off-the-shelf Internet-based health-promotion program, The Preventive Plan (TPP), coupled with nurse-coach support, which aimed to increase patient activation and provide self-management benefits. Materials and methods: A total of 19 COPD patients were recruited, and 14 completed 3-month follow-up in two groups: groups 1 and 2 with more and less advanced COPD, respectively. Change in patient activation was determined with paired t-tests and Wilcoxon signed-rank tests. Benefits and user experience were explored in semistructured interviews, analyzed thematically. Results: Only group 1 improved significantly in activation, from a lower baseline than group 2; group 1 also improved significantly in mastery and anxiety. Both groups felt significantly more informed about COPD and reported physical functioning improvements. Group 1 reported improvements in mood and confidence. Overall, group 2 reported fewer benefits than group 1. Both groups valued nurse-coach support; for group 1, it was more important than TPP in building confidence to self-manage. The design of TPP and lack of motivation to use IT were barriers to use, but disease severity and poor IT skills were not. Discussion: Our findings demonstrate the feasibility of combining nurse-coach support aligned to an Internet-based health resource, TPP, in COPD and provide learning about the challenges of such an approach and the importance of the nurse-coach role

Disminución de reingresos tras una hospitalización por exacerbación de EPOC a través de un modelo de atención domiciliaria

To decrease readmissions at 30 and 90 days post-discharge from a hospital admission for chronic obstructive pulmonary disease exacerbation (COPDE)through the home care model ofthe Ambulatory Chronic Respiratory Care Unit (ACRCU), increase patient survival at one year, and validate our readmission risk scale (RRS). Materials and methods: This was an observational study, with a prospective data collection and a retrospective data analysis. A total of 491 patients with a spirometry diagnosis of chronic obstructive pulmonary disease (COPD) requiring hospitalisation for an exacerbation were included in the study. Subjects recruited within the first year (204 cases) received conventional care (CC). In the following year a home care (HC) programme was implemented and of those recruited that year (287) 104 were included in the ACRCU, administered by a specialised nurse. Results: In the group of patients included in the home care model of the Ambulatory Chronic Respiratory Care Unit(ACRCU) a lower number of readmissions was observed at 30 and 90 days after discharge (30.5% vs. 50%, p = 0.012 and 47.7% vs. 65.2%, p = 0.031, respectively) and a greater one-year survival (85.3% vs. 59.1%, p < 0.001). The validation of our RRS revealed that the tool’s capacity to predict readmissions at both 30 and 90 days was not high (AUC = 0.69 and AUC = 0.66, respectively). The inclusion of exacerbator or fragile COPD patients in the ACRCU could achieve a decrease in readmissions and an increase in survival. The number of episodes of exacerbation within the 12 months prior to the hospital admission is the variable that best predicts the risk of readmissionDisminuir los reingresos a los 30 y 90 días tras el alta por un ingreso hospitalario por exacerbación de enfermedad pulmonar obstructiva crónica (EPOC) a través del modelo de atención domiciliaria de la Unidad de Cuidados Crónicos Respiratorios Ambulatorios (UCCRA), aumentar la supervivencia al año y validar nuestra escala de riesgo de reingreso (ERR). Estudio observacional con recogida prospectiva de datos. Se incluyó en el estudio a un total de 491 pacientes con diagnóstico espirométrico de enfermedad pulmonar obstructiva crónica que requirieron hospitalización por una agudización. Los sujetos reclutados dentro del primer año (204 casos) recibieron atención convencional (AC). Al año siguiente se implementó un programa de atención domiciliaria (AD) y de los pacientes reclutados ese año (287), 104 fueron incluidos en la UCCRA con seguimiento de una enfermera especializada. En el grupo de pacientes incluidos en el modelo de atención domiciliaria de la UCCRA se observó un menor número de reingresos a los 30 y 90 días tras el alta (30,5% vs 50%, p = 0,012 y 47,7% vs. 65,2%, p = 0,031, respectivamente) y una mayor supervivencia al año (85,3% vs. 59,1%, p < 0,001). La validación de nuestra ERR reveló que la capacidad de la misma para predecir reingresos tanto a los 30 como a los 90 días no era alta (AUC = 0,69 y AUC = 0,66, respectivamente). La inclusión de pacientes con EPOC agudizadores o frágiles en la UCCRA podría conseguir una disminución de los reingresos y una aumento de la supervivencia. El número de agudizaciones en los 12 meses previos al ingreso hospitalario es la variable que mejor predice el riesgo de reingres

The Feasibility and Efficacy of Telespirometry for Pulmonary Monitoring of Cystic Fibrosis: A Systematic Review

Background: Spirometry via telehealth (telespirometry) involves remote monitoring of lung function, which is useful to detect pulmonary changes and increase continuity of care for patients with cystic fibrosis (CF). Purpose: This systematic review aims to evaluate the feasibility and efficacy of telespirometry assessments for paediatric and adult CF patients. Method: A comprehensive search of health-related databases (CINAHL, Emcare (Ovid), Medline (Ovid), PEDRo and Scopus) was conducted. For inclusion, patients had to be clinically diagnosed with CF and studies could be of any study design or level according to the National Health and Medical Research Council (NHMRC) evidence hierarchy, had to use telespirometry devices for lung function tests, and be written or translated into English. The Crowe Critical Appraisal Tool (CCAT) was used to assess study quality, while also accounting for potential sources of bias encountered during the review process. Data was exported and summarised using the population, intervention, comparators, and outcomes (PICO) framework in Microsoft excel, to provide clinical recommendations. Results: Fourteen studies were included, with participants ranging from 5 to 44-years-old. Thirteen trials were performed domestically, while sample sizes and baseline patient characteristics varied. Nine studies analysed a control and intervention group. All studies varied in the intervention regime and clinical support provided. Collectively, the literature indicated poor patient adherence to telespirometry, which acted as a barrier to gauging its efficacy. Although appearing to be effective in detecting pulmonary deterioration, inconsistencies in pulmonary exacerbation (PEx) criteria were identified and lack of significant improvements in pulmonary outcomes were observed. Conclusion: Poor quality literature and small sample sizes increased risk of bias and restricted the application of the results to clinical practice. The current evidence base is limited by minimal experimental studies, lack of standardised telespirometry protocols, and criteria for PExs and poor patient compliance. Recommendations: At this stage, telespirometry for CF monitoring should be used by motivated and rurally/remotely located patients to complement in-person consults until its uptake is improved and accuracy and clinically efficacy can be ascertained