Outcome of Hospitalization for COVID-19 in Patients with Interstitial Lung Disease. An International Multicenter Study.

Rationale: The impact of coronavirus disease (COVID-19) on patients with interstitial lung disease (ILD) has not been established.Objectives: To assess outcomes in patients with ILD hospitalized for COVID-19 versus those without ILD in a contemporaneous age-, sex-, and comorbidity-matched population.Methods: An international multicenter audit of patients with a prior diagnosis of ILD admitted to the hospital with COVID-19 between March 1 and May 1, 2020, was undertaken and compared with patients without ILD, obtained from the ISARIC4C (International Severe Acute Respiratory and Emerging Infection Consortium Coronavirus Clinical Characterisation Consortium) cohort, admitted with COVID-19 over the same period. The primary outcome was survival. Secondary analysis distinguished idiopathic pulmonary fibrosis from non-idiopathic pulmonary fibrosis ILD and used lung function to determine the greatest risks of death.Measurements and Main Results: Data from 349 patients with ILD across Europe were included, of whom 161 were admitted to the hospital with laboratory or clinical evidence of COVID-19 and eligible for propensity score matching. Overall mortality was 49% (79/161) in patients with ILD with COVID-19. After matching, patients with ILD with COVID-19 had significantly poorer survival (hazard ratio [HR], 1.60; confidence interval, 1.17-2.18; P = 0.003) than age-, sex-, and comorbidity-matched controls without ILD. Patients with an FVC of <80% had an increased risk of death versus patients with FVC ≥80% (HR, 1.72; 1.05-2.83). Furthermore, obese patients with ILD had an elevated risk of death (HR, 2.27; 1.39-3.71).Conclusions: Patients with ILD are at increased risk of death from COVID-19, particularly those with poor lung function and obesity. Stringent precautions should be taken to avoid COVID-19 in patients with ILD.

MISSION ABC: transforming respiratory care through one-stop multidisciplinary clinics - an observational study.

OBJECTIVES: The Modern Innovative Solutions to Improve Outcomes in Asthma, Breathlessness and Chronic Obstructive Pulmonary Disease (COPD) (MABC) service aimed to enhance disease management for chronic respiratory conditions through specialist multidisciplinary clinics, predominantly in the community. This study assesses the outcomes of these clinics. DESIGN: This study used a prospective, longitudinal, participatory action research approach. SETTING: The study was conducted in primary care practices across Hampshire, UK. PARTICIPANTS: Adults aged 16 years and above with poorly controlled asthma or COPD, as well as those with undifferentiated breathlessness not under specialist care, were included. INTERVENTIONS: Participants received care through the multidisciplinary, specialist-led MABC clinics. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcomes included disease activity, quality of life and healthcare utilisation. Secondary outcomes encompassed clinic attendance, diagnostic changes, patient activation, participant and healthcare professional experiences and cost-effectiveness. RESULTS: A total of 441 participants from 11 general practitioner practices were recruited. Ninety-six per cent of participants would recommend MABC clinics. MABC assessments led to diagnosis changes for 64 (17%) participants with asthma and COPD and treatment adjustments for 252 participants (57%). Exacerbations decreased significantly from 236 to 30 after attending the clinics (p<0.005), with a mean reduction of 0.53 exacerbation events per participant. Reductions were also seen in unscheduled and out-of-hours primary care attendance, emergency department visits and hospital admissions (all p<0.005). Cost savings from reduced exacerbations and healthcare utilisation offset increased medication costs and clinic expenses. CONCLUSIONS: Specialist-supported multidisciplinary teams in MABC clinics improved diagnosis accuracy and adherence to guidelines. High patient satisfaction, disease control improvements and reduced exacerbations resulted in decreased unscheduled healthcare use and cost savings. TRIAL REGISTRATION NUMBER: NCT03096509.

Measurement of Vital Signs Using Lifelight Remote Photoplethysmography: Results of the VISION-D and VISION-V Observational Studies.

BACKGROUND: The detection of early changes in vital signs (VSs) enables timely intervention; however, the measurement of VSs requires hands-on technical expertise and is often time-consuming. The contactless measurement of VSs is beneficial to prevent infection, such as during the COVID-19 pandemic. Lifelight is a novel software being developed to measure VSs by remote photoplethysmography based on video captures of the face via the integral camera on mobile phones and tablets. We report two early studies in the development of Lifelight. OBJECTIVE: The objective of the Vital Sign Comparison Between Lifelight and Standard of Care: Development (VISION-D) study (NCT04763746) was to measure respiratory rate (RR), pulse rate (PR), and blood pressure (BP) simultaneously by using the current standard of care manual methods and the Lifelight software to iteratively refine the software algorithms. The objective of the Vital Sign Comparison Between Lifelight and Standard of Care: Validation (VISION-V) study (NCT03998098) was to validate the use of Lifelight software to accurately measure VSs. METHODS: BP, PR, and RR were measured simultaneously using Lifelight, a sphygmomanometer (BP and PR), and the manual counting of RR. Accuracy performance targets for each VS were defined from a systematic literature review of the performance of state-of-the-art VSs technologies. RESULTS: The VISION-D data set (17,233 measurements from 8585 participants) met the accuracy targets for RR (mean error 0.3, SD 3.6 vs target mean error 2.3, SD 5.0; n=7462), PR (mean error 0.3, SD 4.0 vs mean error 2.2, SD 9.2; n=10,214), and diastolic BP (mean error -0.4, SD 8.5 vs mean error 5.5, SD 8.9; n=8951); for systolic BP, the mean error target was met but not the SD (mean error 3.5, SD 16.8 vs mean error 6.7, SD 15.3; n=9233). Fitzpatrick skin type did not affect accuracy. The VISION-V data set (679 measurements from 127 participants) met all the standards: mean error -0.1, SD 3.4 for RR; mean error 1.4, SD 3.8 for PR; mean error 2.8, SD 14.5 for systolic BP; and mean error -0.3, SD 7.0 for diastolic BP. CONCLUSIONS: At this early stage in development, Lifelight demonstrates sufficient accuracy in the measurement of VSs to support certification for a Level 1 Conformité Européenne mark. As the use of Lifelight does not require specific training or equipment, the software is potentially useful for the contactless measurement of VSs by nonclinical staff in residential and home care settings. Work is continuing to enhance data collection and processing to achieve the robustness and accuracy required for routine clinical use. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/14326.

Evaluation of telehealth support in an integrated respiratory clinic.

Supporting self-management is key in improving disease control, with technology increasingly utilised. We hypothesised the addition of telehealth support following assessment in an integrated respiratory clinic could reduce unscheduled healthcare visits in patients with asthma and COPD. Following treatment optimisation, exacerbation-prone participants or those with difficulty in self-management were offered telehealth support. This comprised automated twice-weekly telephone calls, with a specialist nurse triaging alerts. We performed a matched cohort study assessing additional benefits of the telehealth service, matching by: confirmed diagnosis, age, sex, FEV1 percent predicted, smoking status and ≥1 exacerbation in the last year. Thirty-four telehealth participants were matched to twenty-nine control participants. The telehealth cohort generated 165 alerts, with 29 participants raising at least one alert; 88 (53.5%) alerts received a call discussing self-management, of which 35 (21%) received definitive advice that may otherwise have required an unscheduled healthcare visit. There was a greater reduction in median exacerbation rate across both telehealth groups at 6 months post-intervention (1 to 0, p < 0.001) but not in control groups (0.5 to 0.0, p = 0.121). Similarly, there was a significant reduction in unscheduled GP visits across the telehealth groups (1.5 to 0.0, p < 0.001), but not the control groups (0.5 to 0.0, p = 0.115). These reductions led to cost-savings across all groups, but greater in the telehealth cohorts. The addition of telehealth support to exacerbation-prone patients with asthma or COPD, following comprehensive assessment and treatment optimisation, proved beneficial in reducing exacerbation frequency and unscheduled healthcare visits and thus leads to significant cost-savings for the NHS.Clinical Trial Registration: ClinicalTrials.gov: NCT03096509.

Developing the Accuracy of Vital Sign Measurements Using the Lifelight Software Application in Comparison to Standard of Care Methods: Observational Study Protocol.

BACKGROUND: Vital sign measurements are an integral component of clinical care, but current challenges with the accuracy and timeliness of patient observations can impact appropriate clinical decision making. Advanced technologies using techniques such as photoplethysmography have the potential to automate noncontact physiological monitoring and recording, improving the quality and accessibility of this essential clinical information. OBJECTIVE: In this study, we aim to develop the algorithm used in the Lifelight software application and improve the accuracy of its estimated heart rate, respiratory rate, oxygen saturation, and blood pressure measurements. METHODS: This preliminary study will compare measurements predicted by the Lifelight software with standard of care measurements for an estimated population sample of 2000 inpatients, outpatients, and healthy people attending a large acute hospital. Both training datasets and validation datasets will be analyzed to assess the degree of correspondence between the vital sign measurements predicted by the Lifelight software and the direct physiological measurements taken using standard of care methods. Subgroup analyses will explore how the performance of the algorithm varies with particular patient characteristics, including age, sex, health condition, and medication. RESULTS: Recruitment of participants to this study began in July 2018, and data collection will continue for a planned study period of 12 months. CONCLUSIONS: Digital health technology is a rapidly evolving area for health and social care. Following this initial exploratory study to develop and refine the Lifelight software application, subsequent work will evaluate its performance across a range of health characteristics, and extended validation trials will support its pathway to registration as a medical device. Innovations in health technology such as this may provide valuable opportunities for increasing the efficiency and accessibility of vital sign measurements and improve health care services on a large scale across multiple health and care settings. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14326.

An Evaluation of Agreement of Breathing Rates Measured by a Novel Device, Manual Counting, and Other Techniques Used in Clinical Practice: Protocol for the Observational VENTILATE Study.

BACKGROUND: Respiratory rate (RR) is the most sensitive physiological observation to predict clinical deterioration on hospital wards, and poor clinical monitoring has been highlighted as a primary contributor to avoidable mortality. Patients in intensive care have their RR monitored continuously, but this equipment is rarely available on general hospital wards. OBJECTIVE: The primary objective is to assess the accuracy of the RespiraSense device in comparison with other methods currently used in clinical practice. The secondary objective is to assess the accuracy of the RespiraSense device in participants in different positions and when reading aloud. METHODS: A single-center, prospective observational study will investigate the agreement of the RespiraSense device as compared with other device measurements (capnography, electrocardiogram) and the current standard measurement of RR (manual counting by a trained health care professional). The different methods will be employed concurrently on the same participant as part of a single study visit. RESULTS: Recruitment to this study has not yet started as funding decisions are still pending. Therefore, results are not available at this stage. It is anticipated that the data required could be collected within 2 months of first recruitment to the study and data analysis completed within 6 months of the study start date. CONCLUSIONS: The Evaluation of Agreement of Breathing Rates Measured by a Novel Device, Manual Counting, and Other Techniques Used in Clinical Practice (VENTILATE) study will provide further validation of the use of the RespiraSense device in subjects with abnormal respiratory rates. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/15437.

Modern Innovative Solutions to Improve Outcomes in Asthma, Breathlessness, and Chronic Obstructive Pulmonary Disease (MISSION ABC): Protocol for a Mixed-Methods Study.

BACKGROUND: A high proportion of the costs for respiratory diseases are generated by a relatively small group of patients with severe disease (recognized or unrecognized) or complex problems that include multimorbidity, at-risk behaviors, and socioeconomic disadvantage. These patients often struggle to engage with the structured, proactive, care approaches for chronic disease management advocated for asthma and chronic obstructive pulmonary disease (COPD), resulting in repeated emergency use of both primary and secondary health care. An integrated approach for the management of complex patients, incorporating both specialist and primary care teams' expertise, may be effective in improving outcomes for such high-risk patients. However, the evidence is mixed, and there is a need for evaluation of models of integrated care in routine "real-world" clinical settings. OBJECTIVE: This mixed-methods protocol examines the implementation of a novel integrated care model for patients with airways disease and undifferentiated breathlessness by using both quantitative and qualitative evaluation of processes, patient and health care professional experiences, and clinical outcomes throughout the clinic cycles. It aims to establish whether Modern Innovative Solutions to Improve Outcomes in Asthma, Breathlessness, and Chronic Obstructive Pulmonary Disease (MISSION ABC), including innovative diagnostic and self-management tools, can deliver improvements in health service use and clinical outcomes for the different patient groups (asthma, breathlessness, and COPD) and compares the 12-month period prior to the first patient visit and the 6-month period following the last visit. METHODS: A combination of study designs is required to evaluate all aspects of the service: participatory action research approach, involving real-time evaluation at each clinic to inform subsequent clinics; before-and-after study for patient outcomes before and after clinic attendance; and qualitative methods (interviews and focus groups). RESULTS: The results will be compiled and published in April 2019. CONCLUSIONS: Evaluation of the clinic cycles will include consideration of qualitative data from patients, carers, and health care professionals in addition to quantitative outcomes for service implementation and patient factors. The long-term impact of the service will be evaluated using clinical and health service outcomes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/9228.