Statistical Process Control Improves The Feasibility Of Remote Physiological Monitoring In Patients With Chronic Obstructive Pulmonary Disease

Abstract

Background

Exacerbations of chronic obstructive pulmonary disease (COPD) occur with increasing frequency as the disease progresses and account for poor health status, worse prognosis, and higher healthcare expenditure.

Methods

We developed a networked system for remote physiological monitoring (RPM) at home and optimized it with statistical process control (SPC) with the goal of earlier detection of COPD exacerbations. We enrolled 17 patients with moderate to severe COPD with a mean (SD) age of 71.1 (7.2) years. We obtained daily symptom scores, treatment adherence and activity levels using a programmable device, and measured daily slow and forced spirometry (FEV₁, FVC, PEF), inspiratory capacity (IC) and oxygenation (SpO₂). To identify exacerbations, we developed rolling prediction intervals for FVC, FEV₁, IC and SpO₂ using SPC.

Results

The time taken to perform daily monitoring was reduced from 12.7 (5.4) minutes to 6.5 (2.6) minutes through software refinements during the study. Adherence to forced and slow spirometry was 62.6% and 62.4%, respectively. The within-subject coefficients of variation for FEV₁, PEF and IC were 12.2%, 16.2%, and 13.1%, respectively. Event rates per patient-year for exacerbations were: self-reported 0.42, 2/3 Anthonisen Criteria (AC) 0.42, modified AC 2.23, systemic corticosteroid use 0.56, and antibiotic use 0.56.

Conclusion

We successfully implemented a networked system for RPM of symptoms, treatment adherence, and physiology at home in patients with COPD. We demonstrated that SPC improves the feasibility of RPM in COPD patients which may increase the likelihood of detecting COPD exacerbations.

Keywords:

• chronic obstructive pulmonary disease exacerbations
• early detection
• treatment adherence
• home monitoring

Disclosure

During this study, CBC received consulting fees from eResearch Technologies Inc (ERT) for serving as Medical Director of their Clinical Services Division, also reports grants from eResearch Technologies, personal fees from GlaxoSmithKline, non-financial support from Equinox Fitness Clubs, personal fees from PulmonX, outside the submitted work. Mr Michael Taylor reports Previously employed by the company whose product was used in the investigation. This investigation was funded by ERT, Inc. The authors report no other conflicts of interest in this study.