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Log-rank and Wilcoxon tests of equality of the survivorship functions across the two drug strata. Graphs of the Nelson-Aalen and Kaplan-Meier estimators of the survivorship function from the hmohiv data.
Rationale: Chronic obstructive pulmonary disease, (COPD) is a major cause of morbidity and mortality in the United States. Methods: This was a retrospective analysis of prospectively collected data using an electronic diary to record daily PEFR and symptoms in severe and very severe COPD patients.
Results: A total of 104 severe and very severe COPD patients met entry criteria, and were observed for 37,702 patient-days. Conclusion: Patients with severe to very severe COPD with greater changes in PEFR have shorter 6MWD, reduced time to first hospitalization, more frequent hospitalizations, and higher all-cause mortality despite similar demographic, spirometric and comorbid parameters at baseline. In asthma patients, peak expiratory flow rate (PEFR) measurement has been promoted as a useful tool for assessing airway obstruction and titrating therapy. In an attempt to assess the utility of PEFR monitoring in COPD management, we analyzed daily PEFR variability in patients with severe and very severe COPD as a marker of disease instability and its impact on patient-related outcomes. This is a retrospective analysis of prospectively collected data from June 2005 to May 2011. Secondary outcomes included time to first hospitalization, hospitalization rate, length of hospitalization, and all-cause mortality. Univariate comparisons of baseline characteristics and outcomes were conducted using a two-sample t-test for continuous data and a chi-square test for categorical data. There were no differences in baseline demographic features, spirometric measures, oxygen use or comorbidities between the 2 groups (Table 2).
There were no statistically significant differences in the prevalence of daily symptoms, including breathlessness, wheezing, cough, sputum quantity, purulence and thickness, sore throat, nasal congestion and body temperature between the stable and unstable groups (Table 4).
Our study shows that patients with severe to very-severe COPD who have greater changes in the daily PEFR (unstable group) have less stable disease. Few studies have looked at the patterns and changes in daily PEFR measurements in COPD patients. One of the limitations of our study is the determination of the slope threshold used to define stable and unstable groups. This study also excluded patients with mild and moderate COPD, and future studies looking at the significance of PEFR changes in these patients are needed. Our study showed that greater variability in daily PEFR measurements in patients with severe to very severe COPD (with similar comorbidities, age, medication use, and symptoms) could help to objectively identify patients with more unstable disease with a propensity for greater exacerbation and a higher mortality. The COPD Foundation owns the copyright to all content in the JCOPDF, unless otherwise noted.
The COPD Foundation is a nonprofit, tax-exempt charitable organization under Section 501(c)(3) of the Internal Revenue Code. Peak expiratory flow rate (PEFR) monitoring could provide a daily objective measurement of lung function in COPD patients at home. Rates of PEFR change were used to characterize patients into stable and unstable groups determined by the distribution of slopes.

There were no significant differences in baseline symptoms, demographics, forced expiratory volume in 1 second (FEV1) or comorbidities between stable versus unstable groups. Daily peak flow monitoring can be a useful tool in identifying COPD patients predisposed to worse outcomes. Daily peak expiratory flow rate and disease instability in chronic obstructive pulmonary disease. Currently, monitoring of COPD is limited mainly to pulmonary function testing using office- or laboratory-based spirometry, without effective tools to objectively monitor disease activity at home on a day-to-day basis.
It is not only cheap, but has high reproducibility and user compliance rates, making it a useful tool for ambulatory monitoring of asthma.4 In COPD, however, the utility of PEFR monitoring remains unclear.
We hypothesized that individuals with greater variability in daily PEFR would signal an unstable patient population with worse outcomes. Data from 201 patients was available and 104 patients met the inclusion criteria with 37,702 total patient-days available for analysis. Daily PEFR, dyspnea, sputum (quantity, color, and thickness), cough, wheezing, sore throat, nasal congestion and body temperature were recorded.
The slope of the change over the duration of enrollment was then determined using linear regression.
Log-rank tests were used to compare all-cause mortality and time to first hospitalization between stable and unstable groups and illustrated using Kaplan-Meier survival curves. These patients were divided into the stable (39 patients) and unstable (65 patients) (Figure 2). Medication usage at enrollment, including short- and long-acting bronchodilator, steroids, theophylline, anti-acids, antibiotics, and statin, as well as baseline PEFR measurements, were also similar.
Forty-three percent (n=23) of patients in the stable group and 60% (n=27) in the unstable group comprised this group of hospitalized patients.
These patients had significantly shorter 6MWD and a higher prevalence of inhaled corticosteroid use on enrollment. Donaldson et al identified patients with frequent and infrequent exacerbations and found that there was a greater decline in FEV1 and PEFR in those with more frequent exacerbations.9 In our study, we looked at changes in daily PEFR over time and showed that greater increases or decreases in PEFR portend worse outcomes, likely signaling disease instability. The slope method was used for data analysis because of the ability to detect the degree of changes over time. In addition, assessing the histopathologic characteristics (such as airway wall thickness and smooth muscle mass), prevalence of inflammatory cells and the magnitude and types of emphysema in the unstable compared to the stable daily PEFR group could help to further understand and phenotype these patients. Exacerbation-free days, time to first hospitalization, hospitalization rate, length of hospitalization, and all-cause mortality were assessed. Data on demographics, baseline spirometry measurements, 6 minute walk distance (6MWD), comorbidities, and oxygen and medication use were collected for analysis. Exacerbation-free days, instead of the rates, were used as the availability of daily symptom measurements and allows us to quantify the exact number of days with worse symptoms, rather than grouping them into 1 event, obscuring duration and severity of the symptoms. Of these patients, the mean time to first hospitalization was 163 days in the unstable group, compared to 286 days in the stable group (p=0.017) (Figure 4), also seen on the Kaplan-Meier curve (Figure 5). Of the patients who had at least 1 hospitalization, patients in the unstable group had significantly shorter time to first hospitalization, higher rates of hospitalization and longer hospital length of stay compared to those in the stable group.

Donaldson also examined the alpha value from the detrended fluctuation analysis of the daily diary symptoms and PEFR in moderate to severe COPD patients, and found a positive relationship between self-similarity of daily PEFR and exacerbation frequency.13 The different findings between these studies may be due to differences in the patient populations studied.
This method was chosen over the coefficient of variation as it allowed for better discrimination of PEFR changes over a longer period. Alternative projections of mortality and disability by cause 1990-2020: global burden of disease study.
Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Precision and accuracy of self-measured peak expiratory flow rates in chronic obstructive pulmonary disease. Relation between FEV1 and peak expiratory flow in patients with chronic airflow obstruction.
Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. CD4 T-lymphocyte activation is associated with peak expiratory flow variability in childhood asthma. Underreporting Exacerbation of Chronic Obstructive Pulmonary Disease in a Longitudinal Cohort. A telemedicine-based intervention reduces the frequency and severity of COPD exacerbation symptoms: A randomized, controlled trial. They also had 34.7 fewer days of exacerbation-free days, when adjusted for the study enrollment duration, although this value was not statistically significant. It is important to note that there were no differences in patient demographics, comorbidities, or baseline symptoms between the stable and unstable groups. Our findings may indicate a patient group that is experiencing dynamic changes in airflow due to chronic inflammation and sputum production. An exacerbation was considered if the modified symptoms score was greater than 1, as illustrated in Table 1. These findings show that the patients with greater changes in PEFR are sicker, have worse disease and overall functional status, and support monitoring of daily PEFR as a useful risk stratification tool for COPD patients, in addition to GOLD staging and symptom scores. Therefore, there exists a phenotype within severe and very severe COPD patients who experience greater variability in airway obstruction that may portend higher morbidity and mortality. One hypothesis for this finding is that the patients in the unstable group have more current active airways dysfunction with greater barriers to participate in the study secondary to worse functional status, compliance with PEFR or unreported adverse outcomes. Further studies are needed to assess the functional status in these patients, and to define a standardized method to prospectively determine a clinically significant slope cutoff point.

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