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We have performed a pilot study of daily domiciliary pulse oximetry in a patient sample from the London COPD cohort. Using prospective diary card data allowed us to precisely define the onset of exacerbation symptoms. We have therefore been able to describe the extent of normal variation in heart rate and SpO2 on symptom free days, the disease and demographic characteristics that affect this baseline variation, and the time-course of changes with exacerbation. We go on to report the ability of such data to differentiate exacerbation from both stable disease and day-to-day symptom variation.
We first assessed the extent of day-to-day variation in heart rate, SpO2 and PEF. To do this, we calculated the individual mean and SD of these variables in the stable (symptom free) state. After initial distribution of the oximeters to each patient, the first seven days of data were ignored, to allow each patient to develop an oximetry measurement routine. The mean and SD of the heart rate, SpO2 and PEF were then calculated for the next 30 symptom free days (these data were normally distributed). For this analysis, data from seven days preceding any exacerbation to 14 days following exacerbation recovery were excluded. Symptom days were also ignored. On 34 otherwise stable days (3.7%), in 30 of the 31 patients, data were incomplete necessitating the inclusion of additional days such that each patient had thirty stable days monitoring of all three variables (the final patient had a prolonged period in which oxygen saturation was not recorded, prior to re-education). A period of 30 days was chosen after initial inspection of the data revealed stabilisation of the SD took up to three weeks. This methodology implies that on subsequent baseline (symptom free) days, 95% of values would be expected to lie between the mean +/- 1.96 (approximately 2) SD.
Table 1 also reports the mean of the individual patient mean and SD for the pulse oximetry variables and PEF. These data were normally distributed and the analysis is based on 930 patient-days of follow-up. The mean of the individual SD for heart rate, SpO2 and PEF, measures of day-to-day variation in the stable state, were approximately 5 min-1, 1% and 10l min-1 respectively. Therefore, on 95% of stable (symptom free) days patients should have readings within approximately 10 min-1, 2% and 20l min-1 above and below their stable mean value.
There are some limitations of our approach. We present our findings as preliminary but believe these data will be of immediate utility to those monitoring patients with domiciliary oximetry, enabling subsequent validation of our technique in larger cohorts. To establish an individual patient's baseline, our method requires rigorous data collection, at the sensitivity limit of currently available technology. However, with tele-health such methods are increasingly practical. We did not include patients with respiratory failure and it may be that oxygen saturation changes at exacerbation in patients on the steeper part of the oxygen dissociation curve are greater. Patients in atrial fibrillation were also excluded. We do not have data to inform on how long day-to-day variation in the baseline state remains stable. We have previously reported that PEF declines (slowly) with time [11] and we are not able to state how frequently the stable monitoring period would need to be repeated. Our data do not inform on the ability of pulse oximetry to distinguish exacerbation of COPD from other causes of symptom deteriorations in these patients (such as pneumonia), and it is quite likely that such pathologies would also result in heart rate and SpO2 changes. Exacerbation of COPD remains a clinical diagnosis of exclusion and the clinician (and patient) must remain aware that other conditions may mimic or complicate exacerbations [19]. We note that there were fewer unreported exacerbations in this study than we have previously detected from this cohort. Finally, it is important to remark that in some patients (17.5% in this study) it was not possible to ascertain baseline readings on 30 symptom free days, despite prolonged monitoring, and this might limit applicability to a proportion of patients in clinical practice. 2b1af7f3a8