Home monitoring for patients with ILD and the COVID-19 pandemic

Abstract

The current COVID-19 pandemic has challenged the continuity of health care and research. Health-care providers around the world are required to deal with social distancing and quarantine measures, while simultaneously ensuring quality of care for their patients. Consequently, eHealth applications, such as home monitoring, have gained increasing interest during the past months. For the vulnerable population of patients with interstitial lung diseases, home monitoring could be particularly relevant. We describe experiences with home monitoring in interstitial lung diseases, the effect of COVID-19 on its use, and opportunities for more hybrid forms of monitoring. Interstitial lung diseases are a heterogeneous group of often progressive and deadly diseases. Treatment generally consists of immunosuppression or antifibrotic treatment, and supportive measures. Regular hospital visits are required for comprehensive patient support, including monitoring disease course and response to treatment. Lung function (ie, forced vital capacity) is the most used outcome measure to guide treatment decisions, and the accepted primary outcome for clinical trials in interstitial lung disease. Hospital visits can be challenging for patients because of dyspnoea, supplemental oxygen needs, and dependency on caregivers. Furthermore, travel distances can be considerable because in many countries, care for interstitial lung disease is centralised in specialist centres. Hence, monitoring physiological parameters and symptoms at home could have advantages for both clinical practice and research.1Wijsenbeek M Cottin V Spectrum of fibrotic lung diseases.N Engl J Med. 2020; 383: 958-968Crossref PubMed Scopus (176) Google Scholar During the past 5 years, the feasibility and reliability of home monitoring and home spirometry in interstitial lung disease have been increasingly studied. Studies in idiopathic pulmonary fibrosis showed that home spirometry yielded reliable results, predicted disease progression better than did hospital spirometry, and could possibly decrease sample sizes for future trials.2Johannson KA Vittinghoff E Morisset J Lee JS Balmes JR Collard HR Home monitoring improves endpoint efficiency in idiopathic pulmonary fibrosis.Eur Respir J. 2017; 501602406Crossref PubMed Scopus (48) Google Scholar, 3Russell AM Adamali H Molyneaux PL et al.Daily home spirometry: an effective tool for detecting progression in idiopathic pulmonary fibrosis.Am J Respir Crit Care Med. 2016; 194: 989-997Crossref PubMed Scopus (104) Google Scholar A 24-week randomised controlled trial suggested that a home monitoring program tended to improve psychological wellbeing, allowed for individually tailored treatment decisions, and yielded reliable home spirometry results over time.4Moor CC Mostard RLM Grutters JC et al.Home monitoring in patients with idiopathic pulmonary fibrosis. A randomized controlled trial.Am J Respir Crit Care Med. 2020; 202: 393-401Crossref PubMed Scopus (50) Google Scholar Patient satisfaction with home monitoring was high in this study.4Moor CC Mostard RLM Grutters JC et al.Home monitoring in patients with idiopathic pulmonary fibrosis. A randomized controlled trial.Am J Respir Crit Care Med. 2020; 202: 393-401Crossref PubMed Scopus (50) Google Scholar Although these results are promising, other studies struggled with home spirometry. A study5Maher TM Corte TJ Fischer A et al.Pirfenidone in patients with unclassifiable progressive fibrosing interstitial lung disease: a double-blind, randomised, placebo-controlled, phase 2 trial.Lancet Respir Med. 2020; 8: 147-157Summary Full Text Full Text PDF PubMed Scopus (271) Google Scholar published this year in patients with unclassifiable interstitial lung disease used home spirometry (ie, forced vital capacity) as the primary endpoint. However, the planned statistical analysis could not be applied due to highly variable home-based forced vital capacity measurements.5Maher TM Corte TJ Fischer A et al.Pirfenidone in patients with unclassifiable progressive fibrosing interstitial lung disease: a double-blind, randomised, placebo-controlled, phase 2 trial.Lancet Respir Med. 2020; 8: 147-157Summary Full Text Full Text PDF PubMed Scopus (271) Google Scholar In the multinational INMARK study,6Maher T Cottin V Russell A-M et al.Correlation between home and clinic spirometry in subjects with IPF: results from the INMARK trial.Eur Respir J. 2019; 54PA1318Google Scholar a strong correlation between home and hospital spirometry was found at different timepoints, but changes in lung function over time were only weakly correlated. Another study7Wijsenbeek M Bendstrup E Valenzuela C et al.Design of a study assessing disease behaviour during the peri-diagnostic period in patients with interstitial lung disease: the STARLINER study.Adv Ther. 2019; 36: 232-243Crossref PubMed Scopus (11) Google Scholar that used home spirometry and accelerometry to assess disease behaviour in the peri-diagnostic period encountered high measurement variability and some technical issues. These studies were pioneers in this field and have generated valuable insights on how to improve the use of home monitoring in care and research (appendix). One of the main problems has been the measurement variability encountered in some studies. Probable reasons for this variability are insufficiently thorough patient instruction and technical issues with the spirometers. Furthermore, in most studies, patients were masked for their home spirometry results and there was no real-time data transmission to the research team. These factors hampered direct feedback and quality control, causing increasing measurement variation and decreasing adherence over time. An online home monitoring application with technical support in the native language and direct feedback to patients and health-care providers could help to overcome these challenges. Moreover, the role of the patient is crucial. Co-development of home monitoring systems with patients might lead to higher adherence and patient satisfaction with home monitoring.8Moor CC Wapenaar M Miedema JR Geelhoed JJM Chandoesing PP Wijsenbeek MS A home monitoring program including real-time wireless home spirometry in idiopathic pulmonary fibrosis: a pilot study on experiences and barriers.Respir Res. 2018; 19: 105Crossref PubMed Scopus (39) Google Scholar, 9Johannson KA Remote monitoring in idiopathic pulmonary fibrosis: home is where the bluetooth-enabled spirometer is.Am J Respir Crit Care Med. 2020; 202: 316-317Crossref PubMed Scopus (5) Google Scholar The identified statistical analysis challenges could be tackled by predefining the minimum number of measurements that are needed for reliable longitudinal analysis, and unifying the way that missing data and outliers are handled. The COVID-19 outbreak will force the interstitial lung disease community to move further towards digital care, both in clinical practice and for research purposes.10Wong AW Fidler L Marcoux V et al.Practical considerations for the diagnosis and treatment of fibrotic interstitial lung disease during the coronavirus disease 2019 pandemic.Chest. 2020; 158: 1069-1078Summary Full Text Full Text PDF PubMed Scopus (54) Google Scholar Because many patients with interstitial lung disease are older, have impaired lung function, and might be using immunosuppressive drugs, they wisely strive to minimise their risk of exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and stay at home. On top of this, travel and hospital access restrictions exist in many countries.10Wong AW Fidler L Marcoux V et al.Practical considerations for the diagnosis and treatment of fibrotic interstitial lung disease during the coronavirus disease 2019 pandemic.Chest. 2020; 158: 1069-1078Summary Full Text Full Text PDF PubMed Scopus (54) Google Scholar Together, these factors lead to numerous missed clinic visits, affecting care and research. Ongoing trials are facing important protocol deviations as scheduled study visits are cancelled, and enrollment of new patients has paused. As a consequence, the development of novel drug compounds might be considerably slowed down. We currently use our previously developed home monitoring programme, integrated with a video consultation option, to replace face-to-face consultations. Our experience is that home monitoring of lung function, symptoms, and adverse events can secure patient safety from both a care and clinical trial perspective. At the same time, patients are more actively involved in their disease, enhancing self-management. The incremental use of home monitoring and video consultations for patients with interstitial lung disease during the COVID-19 pandemic will provide further valuable information about feasibility, experiences, and the satisfaction of patients and health-care providers. Nevertheless, structured studies are needed to provide more data on long-term safety and the effects of replacing face-to-face consultations with home monitoring in this patient population. Home monitoring can also be used to facilitate international interstitial lung disease registries, with patients taking the lead and collecting most registry data at home. This practice will facilitate meaningful collaboration between patients, doctors, researchers, and other stakeholders to improve insights into disease behaviour and response to therapy across diseases and borders. In addition, it could provide a more definite answer to questions about the reliability of (online) home spirometry in a diverse population and the feasibility of eHealth applications in a multinational setting. Whether home spirometry can be optimised to the extent that it can be used as a primary endpoint in future clinical trials is yet to be seen, but will hopefully become clearer. Given that the COVID-19 pandemic is expected to last longer, clinicians and researchers should team up with different stakeholders to provide high-quality, durable eHealth solutions. By involving patients in the development and evaluation of digital care, eHealth applications can be better adapted to patients' needs and wishes. Moreover, policy makers and insurance companies should be motivated to stimulate research and support further development, optimisation, and up-scaling of digital care. To allow for wide-scale implementation, organisational, legislative, ethical, and reimbursement issues also need to be taken into account. Altogether, the challenges faced in COVID-19 times have also created opportunities to expand novel ways of monitoring in order to improve quality and access of care and research for patients with interstitial lung disease. MSW reports grants and speaker and consultancy fees from Boehringer-Ingelheim, Hoffman la Roche, and consultancy fees from Galapagos and Respivant, outside the submitted work; all grants and fees are paid to her institution. CCM reports grants and consultancy fees from Boehringer-Ingelheim, outside the submitted work; all grants and fees are paid to her institution. GN declares no competing interests. Download .pdf (.21 MB) Help with pdf files Supplementary appendix