Chronic obstructive pulmonary disease COPD is a common disease that affects up to 24 million people in the United States and leads to substantial disabil-ity and death.1 Patients with CO
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e d i t o r i a l s
Systemic Corticosteroids for Acute Exacerbations
of Chronic Obstructive Pulmonary Disease
Richard S Irwin, M.D., and J Mark Madison, M.D
Chronic obstructive pulmonary disease (COPD) is a common disease that affects up to 24 million people
in the United States and leads to substantial disabil-ity and death.1 Patients with COPD have about three acute exacerbations of their disease per year,2 many
of which result in unscheduled visits to a physician
or emergency department and to hospitalization
Although it is currently the fourth leading cause of death in the United States1 and the sixth world-wide,3 COPD is predicted to be the third leading cause of death and fifth leading cause of disability in the world by 2020.3
Although there is no universally accepted defini-tion of COPD4 or an acute exacerbation of COPD,5
because experts have promulgated criteria that vary
in some respects, most current definitions contain the same key elements.4 The definition of the
Glob-al Initiative for Chronic Obstructive Lung Disease6
has gained widespread acceptance: “COPD is a dis-ease state characterized by airflow limitation that is not fully reversible The airflow obstruction is usu-ally both progressive and associated with an abnor-mal inflammatory response of the lungs to noxious particles or gases.” This definition specifies that poorly reversible airflow limitation due to other ob-structive airway diseases (e.g., bronchiectasis,
cyst-ic fibrosis, or asthma) is not included unless these diseases coexist with COPD.4,6
An acute respiratory deterioration in a patient with COPD can be due to many conditions, such as pneumonia, congestive heart failure, pneumotho-rax, and venous thromboembolism, but they are not generally considered acute exacerbations of COPD itself Many have defined an acute exacerbation of COPD as a subjective increase, from base line, in some combination of dyspnea, sputum purulence, and sputum volume owing to acute
tracheobronchi-tis,5,7 which has an infectious cause approximately
80 percent of the time and occurs in a patient with established COPD An important element of this definition is that causes of respiratory deterioration other than acute tracheobronchitis are excluded.5
It is not clear why this definition has not been uni-versally accepted, because it is the one that has been used most consistently in rigorous double-blind, randomized, placebo-controlled trials assessing therapies for an acute deterioration in respiratory status in patients with COPD.8-11
Recent randomized, double-blind, placebo-con-trolled trials or meta-analyses of such trials have fi-nally provided clinicians with high-quality evidence that patients with an acute exacerbation of COPD can benefit from multiple therapies,12 including systemic corticosteroids.10,12 For patients with at least moderate COPD at base line (as defined by a forced expiratory volume in one second [FEV1] of less than 0.8 liter or a ratio of FEV1 to forced vital ca-pacity of less than 50 percent), short-term systemic corticosteroids, in combination with other effective therapies,12 have provided relatively small but clin-ically significant improvements in the duration of hospitalization, lung function, and the incidence of treatment failure; the results have been observed in specific groups of inpatients (those with hypercap-nia and those without hypercaphypercap-nia who are breath-ing spontaneously) and outpatients.10
The results of the study by Aaron et al.11 in this issue of the Journal lend further support to the short-term use of systemic corticosteroids for acute exac-erbations of COPD and fill a gap in information re-garding the role of systemic corticosteroids after discharge from the emergency department As com-pared with placebo, a 40-mg dose of oral prednisone once daily for 10 days, given in combination with
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oral antibiotics and inhaled bronchodilators, de-creased the rate of clinical relapse (defined as an un-scheduled visit to a physician, a return to the emer-gency department, or worsening dyspnea) within the next 30 days (relapse rate, 27 percent, vs 43 percent in the placebo group; P=0.05) and, after
10 days of therapy, improved FEV1 (mean increase from base line, 34 percent vs 15 percent; P=0.007) and dyspnea (P=0.04)
Although we know which patients with an exac-erbation of COPD are likely to benefit from systemic corticosteroids and in which settings, the optimal dose and need for tapering, route of administration, and length of treatment are uncertain The most re-cent data10,11 support the use of a short course of
no more than 10 to 15 days Improved clinical out-comes have been achieved with dosages ranging from 30 mg of oral prednisolone daily or 40 mg of oral prednisone daily in outpatient and emergency department settings to 125 mg of intravenous meth-ylprednisolone every six hours for three days, fol-lowed by 60 mg of oral prednisone daily for four days and then by a gradual tapering of the dose to zero on day 15, in hospitalized patients.10
Oral corticosteroids are often prescribed for pa-tients with stable COPD to prevent acute exacerba-tions and improve lung function and reduce symp-toms However, the benefits of this strategy have been studied in patients with stable COPD of at least moderate severity and have been found to be mar-ginal at best In a meta-analysis of 10 trials, patients with stable COPD who were receiving oral cortico-steroids had a clinically meaningful improvement in FEV1 only 10 percent more often than did similar patients who were receiving placebo.13 Moreover,
in a double-blind, randomized, placebo-controlled trial involving 38 patients, the discontinuation of long-term treatment with oral prednisone did not lead to a significant increase in exacerbations of COPD over a six-month period.14
In summary, evidence from rigorously designed trials has helped to clarify the role of systemic cor-ticosteroids in treating and preventing acute exac-erbations of COPD First, systemic corticosteroids have an established role in the treatment of specific groups of patients who have acute exacerbations of COPD Even though it is still not clear how their beneficial effects are achieved,15 short courses of systemic corticosteroids in patients with at least moderately severe COPD, in combination with other effective therapies, can significantly improve clini-cal outcomes in outpatient and inpatient settings
and after discharge from the emergency depart-ment On the other hand, the role of systemic corti-costeroids in treating acute exacerbations of COPD
in patients who are receiving mechanical ventilation has yet to be rigorously studied Second, although systemic corticosteroids are often prescribed for pa-tients with stable COPD to prevent acute exacerba-tions, the evidence does not support the routine use
of this practice Although it is not the focus of this editorial, the fact that the role of inhaled, as opposed
to systemic, corticosteroids in preventing acute ex-acerbations of COPD continues to be intensely in-vestigated is important.16-18 We encourage readers
to monitor this literature closely
Although the benefits of short-term therapy with systemic corticosteroids during acute exacerbations
of COPD are real and important, they are of moder-ate magnitude and are not the answer to controlling
or reversing the epidemic of COPD In addition, be-cause patients with COPD are at increased risk for drug-related side effects, it is important to inform them of the potential side effects (as well as bene-fits) of corticosteroids, to monitor patients for side effects, and to intervene to minimize such effects whenever possible.19
From the Division of Pulmonary, Allergy, and Critical Care Medi-cine, University of Massachusetts Medical School, Worcester.
Chronic obstructive pulmonary disease surveillance — United States, 1971–2000 MMWR CDC Surveill Summ 2002;51:(SS-6):1-16.
Wedzicha JA Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease Am J Respir Crit Care Med 1998;157:1418-22.
disability by cause 1990-2020: Global Burden of Disease Study Lan-cet 1997;349:1498-504.
ob-structive pulmonary disease Am J Respir Crit Care Med 2003;167: 678-83.
Lancet 1998;352:467-73.
Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: NHLBI/WHO Global Initia-tive for Chronic ObstrucInitia-tive Lung Disease (GOLD) Workshop sum-mary Am J Respir Crit Care Med 2001;163:1256-76.
bronchitis Chest 2000;117:Suppl 2:380S-385S.
obstructive pulmonary disease exacerbations: a meta-analysis JAMA 1995;273:957-60.
acute exacerbations of COPD: a summary and appraisal of pub-lished evidence Chest 2001;119:1190-209.
Corticoster-oid therapy for patients with acute exacerbation of chronic obstruc-tive pulmonary disease: a systematic review Arch Intern Med 2002; 162:2527-36.
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prednisone after emergency treatment of chronic obstructive
pul-monary disease N Engl J Med 2003;348:2618-25.
man-agement of acute exacerbations of COPD: clinical practice
guide-line Chest 2001;119:1185-9.
patients with stable chronic obstructive pulmonary disease: a
meta-analysis Ann Intern Med 1991;114:216-23.
sys-temic corticosteroids in patients with COPD: a randomized trial Am
J Respir Crit Care Med 2000;162:174-8.
and short-term response to prednisone in chronic obstructive
pulmo-nary disease: a randomised controlled trial Lancet 2000;356:1480-5.
cortico-steroids in chronic obstructive pulmonary disease: a systematic review of randomized placebo-controlled trials Am J Med 2002;
113:59-65.
Herwaarden C Effect of discontinuation of inhaled corticosteroids
in patients with chronic obstructive pulmonary disease: the COPE study Am J Respir Crit Care Med 2002;166:1358-63.
fluticasone in the treatment of chronic obstructive pulmonary dis-ease: a randomised controlled trial Lancet 2003;361:449-56.
therapy for COPD: a critical review Chest 1997;111:732-43.
Copyright © 2003 Massachusetts Medical Society.
Improving the Quality of Care — Can We Practice
What We Preach?
Earl P Steinberg, M.D., M.P.P
It has been 30 years since Wennberg and Gittelsohn
published their landmark article demonstrating
substantial variation among different geographic
areas in the provision of medical services.1 Since
then, investigators have found variation in the
de-livery of virtually every aspect of health care that has
been examined From the perspective of the quality
of care, the variation that is the greatest cause for
concern is that between actual practice and
evi-dence-based “best practice.”
Over the past 30 years, progress has been made
in several areas that are vital to quality improvement
Practice guidelines have become more rigorously
evidence-based and are now packaged in ways that
make it easier to put them into practice
Tremen-dous progress has been made in the development of
valid, reliable, and practical measures of the quality
of care2 that are now applied in managed care3 and
fee-for-service settings.4 There are many indications
of an increased focus on quality, and we have made
great progress in our understanding of factors that
contribute to substandard quality2 and of
interven-tions that do (and those that do not) improve the
quality of care.2,5,6
In this issue of the Journal, McGlynn and
col-leagues7 report the results of a large national study
of the content of care provided to adults between
1996 and 1998 Although the “headline” finding of
the study is that adults received 55 percent of
rec-ommended care according to 439 process-of-care
measures, the most enlightening findings are those
in the measure-specific results The biggest
limita-tion of the study derives from the likelihood that
documentation was poor in the charts that were
used to determine what care patients had received
Because of this limitation, along with the focus on compliance with multiple recommendations for the management of a given clinical condition rather than on how well the condition was controlled, it would not be appropriate to interpret the findings
of this study as showing that a typical adult in the United States has a 50–50 chance of receiving ade-quate care of a particular clinical condition None-theless, the study adds detailed information to a substantial body of research that shows that the quality of the care delivered in the United States is considerably lower than it should be.8
What will it take to do better? Four actions are likely to have the greatest effect First, quality of care should be measured and reported routinely at both the national and provider-specific (e.g., hos-pital and physician) levels In September 2003, the Agency for Healthcare Research and Quality will publish the first annual National Healthcare Qual-ity Report, which will include 150 measures A sep-arate effort is needed, however, to report on the quality of care delivered by individual facilities and physicians Such an effort would benefit from the involvement of professional societies in measure-ment and quality-improvemeasure-ment activities.9 Both types of activities are consistent with the missions
of professional societies Examples of such leader-ship, as well as the benefits of it, can be observed in the Dialysis Outcomes Quality Initiative of the Na-tional Kidney Foundation,10 the End-Stage Renal Disease (ESRD) Clinical Performance Measures Project,11 and the Guidelines Applied in Practice Initiative of the American College of Cardiology.12