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* From the Hôpitaux Universitaires de Strasbourg (Dr. Kessler), Strasbourg, France; University of Aberdeen (Drs. Ståhl and Haughney), Aberdeen, UK; Marburg University Hospital (Dr. Vogelmeier), Marburg, Germany; Mapi Values (Dr. Trudeau), Lyon, France; Lund University Hospital (Dr. Löfdahl), Lund, Sweden; and Imperial College London (Dr. Partridge), London, UK.
Correspondence to: Romain Kessler, MD, PhD, Department of Pulmonology, Hôpital de Hautpierre, Hôpitaux Universitaires de Strasbourg, Strasbourg, France; e-mail: romain.kessler{at}chru-strasbourg.fr
Abstract
Study objectives: This study was conducted to gain insight into patients’ comprehension, recognition, and experience of exacerbations of COPD, and to explore the patient burden associated with these events.
Design: A qualitative, multinational, cross-sectional, interview-based study.
Setting: Patients’ homes.
Patients: Patients (n = 125) with predominantly moderate-to-very severe COPD (age 
50 years; with two or more exacerbations during the previous year).
Interventions: Patients underwent a 1-h face-to-face interview with a trained interviewer.
Measurements and results: During the preceding year, patients experienced a mean ± SD of 4.6 ± 5.4 exacerbations, after which 19.2% (n = 24) believed they had not fully recovered. Although commonly used by physicians, only 1.6% (n = 2) of patients understood the term exacerbation, preferring to use simpler terms, such as chest infection (16.0%; n = 20) or crisis (16.0%; n = 20) instead. Approximately two thirds of patients stated that they were aware of when an exacerbation was imminent and, in most cases, patients recounted that symptoms were consistent from one exacerbation to another. Some patients (32.8%; n = 41), however, reported no recognizable warning signs. At the onset of an exacerbation, 32.8% of patients (n = 41) stated that they reacted by self-administering their medication. Some patients spontaneously mentioned a fear of dying (12.0%; n = 15) or suffocating (9.6%; n = 12) during exacerbations, and effects on activities, mood, and personal/family relationships were frequently reported. Physicians tended to underestimate the psychological impact of exacerbations compared with patient reports.
Conclusions: This study shows that patients with frequent exacerbations have a poor understanding of the term exacerbation. Patient recollections suggest that exacerbation profiles vary enormously between patients but that symptoms/warning signs are fairly consistent within individuals, and are generally recognizable. Exacerbations appear to have a significant impact on patient well-being, including psychological well-being, and this may be underestimated by physicians.
Key Words: burden • COPD • exacerbation • patient’s perspective
Exacerbations of COPD are associated with substantial symptomatic and physiologic deterioration.12 However, identification of a diagnostic tool or a particular set of features that can be agreed upon to represent a COPD exacerbation continues to elude researchers.34 It is therefore unsurprising that a wide variety of definitions of "exacerbations"—based on changes in patient symptoms and/or the requirement for medical intervention/health-care contact (the most common definition)—have been used in clinical studies over the past 2 decades.4 The lack of a standard definition impacts on outcomes measures used in trials and clinical practice. Good communication between physician and patient, which includes mutual understanding of the vocabulary used during the consultation, is, as always, essential for effective respiratory disease management.5 In this regard, it is important that use of the word exacerbation is clearly defined and standardized so that patients and physicians have the same understanding of the term.
While physicians strive to define COPD exacerbations34 and the impact they have on objective clinical outcomes,1 patients’ own understanding, experience, and recognition of these events have been largely ignored.6 Clinical experience suggests that patients may underestimate the impact of exacerbations on their daily lives and, as in asthma,78 they may overestimate disease control. One survey9 shows that patients with severe breathlessness may often describe their condition as being only mild or moderate in severity, and other studies1011 demonstrate that many patients fail to report their exacerbations to their physician. Using disease-specific instruments, such as the St. George’s Respiratory Questionnaire, Chronic Respiratory Questionnaire, Baseline and Transitional Dyspnea Index, and various generic questionnaires, we know that exacerbations dramatically affect patients’ health-related quality of life (HRQL).101213141516 While these questionnaires try to assess the impact of exacerbations from the patients’ perspective, none were developed specifically to measure HRQL during exacerbations16; and single instruments, because of their predetermined structure, do not consider all disease-specific effects and the overall burden of exacerbations on everyday functioning and emotional well-being.17 As such, we currently have little knowledge of patients’ real-life experience of acute exacerbations of COPD.
We conducted this qualitative interview-based study to gain a greater insight into patients’ comprehension and experience of COPD exacerbations, and to explore the burden of exacerbations from their perspective. During these interviews, the importance and consequences of exacerbations on patients’ everyday lives—in particular their physical and psychological state—were assessed. Patients’ understanding, experience (eg, recognition of warning signs, consistency of symptomatology, actions taken), and views on different aspects of an exacerbation, including the terminology they use to describe such events, were also examined.
Materials and Methods
This was a cross-sectional study conducted in France, Germany, Spain, Sweden, and the United Kingdom involving men and women aged 50 years with a diagnosis of COPD (according to the Global Initiative for Chronic Obstructive Lung Disease guidelines1). Patients were recruited prospectively by 7 general practitioners and 23 respiratory physicians during normal clinic visits by convenience sampling. During this visit, physicians discussed the study with their patients and, after assessing their eligibility, invited them to participate in a face-to-face interview with a trained interviewer. Physicians also recorded clinical information (sociodemographic status, clinical parameters, COPD history, symptoms, exacerbation history [including health-service use], and treatments) about their patient on a standardized case report form and rated the global physical and psychological impact of the disease and exacerbations on the patient. On the case report form, exacerbations were defined as a worsening of respiratory symptoms such that bronchodilators, and/or oral corticosteroids, and/or antibiotics, and/or oxygen therapy, and/or hospitalization were required.
The following inclusion criteria were used in an attempt to obtain a uniform patient population: FEV1/FVC < 70%; two or more exacerbations (defined in patients’ medical records as a worsening of respiratory symptoms such that medical intervention in the form of oral corticosteroids, and/or antibiotics, and/or hospitalization was required [as used previously1819]) during the previous year; and one or more episode in the past 6 months. Hospitalized patients and those with serious comorbidities (lung cancer or heart failure not associated with COPD), asthma, or a history of psychiatric disorders, cognitive impairment, or insufficient language skills were excluded. All patients gave written informed consent.
After the initial physician visit, patients telephoned their local study coordinator to arrange an appointment for the interview and gain further information about the study. All patients were subsequently interviewed at home, with the interviewer using a semistructured interview guide (Appendix). The interviews were conducted between July and September 2003 in France, Germany, Spain, and Sweden, and between March and May 2004 in the United Kingdom. At the start of the 1-h interview, patients were questioned about their interpretation and comprehension of the term exacerbation, and were asked to describe what constitutes an exacerbation (described to patients as the type of episode when breathing gets so bad that treatment or hospitalization is required) in their own words. The remainder of the interview covered topics related to sociodemographic and clinical status, and their (and their families’) experiences before, during, after, and between COPD exacerbations (including their last exacerbation). These experiences encompassed awareness and recognition of exacerbations, actions taken, feelings and concerns, how patients cope, treatment received, and symptoms. Data were also collected about the impact of exacerbations on activities of daily living (ADL) [including the ability to perform certain tasks], relationships, mood, and work. The questions related to all retrospective patient-defined exacerbations, including those that were not reported to their physician. During the interview, as is likely in a routine clinic visit, patients recounted their experiences of exacerbations while in a stable state. No attempt could be made to confirm the authenticity of their recollections.
Analysis
The aim was to recruit 125 patients (25 patients per country) according to the specific inclusion and exclusion criteria. It was predefined that 50% of patients should be aged 50 to 65 years, and 50 to 75% of patients completing the interview should be men.
The face-to-face interviews were transcribed verbatim and their thematic content analyzed. To give some indication of concerns, patients were asked to assess their worries about exacerbations using a linear, subjective visual analog scale (VAS) [similar to that used previously20], where 0 = not at all, and 100 = extremely. Patients were also asked to rate their general feelings during stable disease and during an exacerbation using a similar VAS, where 0 = worst possible, and 100 = best possible. Physicians rated the global impairment associated with COPD and last documented exacerbation (ie, the last exacerbation during which the patient visited their physician) using a VAS, where 0 = not at all impaired, and 100 = extremely impaired, to determine whether their perception of their patient’s impairment was consistent with patients’ own evaluation. In addition, physicians rated the physical and psychological impact of the disease on the patient in a stable state and during their last documented exacerbation using a 5-point scale (not at all, a little bit, moderately, a lot, extremely).
Responses to individually administered questions are presented. Data for the whole population are described by their frequency and mean ± SD, mean (median [range]), or as the number and percentage of patients with a particular response choice. Data were collated for open-ended questions according to comparable patient responses. Where percentages are given, data are expressed as a percentage of the whole population rather than as a percentage of patients who responded to the question. As patient data may be missing for some questions, percentages will not necessarily add up to 100%. As a consequence of patients being allowed to omit questions or as a result of patients providing multiple replies to some questions, the number of answers for open-ended questions does not always correspond to the total number of respondents. The small sample size, recruitment procedure, and use of open-ended questions meant that formal testing for statistical differences was not appropriate, nor was it possible, or our intention, to examine the influence of baseline characteristics on patient responses.
Results
Baseline Demographics and Disease Characteristics
A total of 125 patients (mean age, 66.4 ± 8.5 years; 65.5% men) were recruited from France (n = 25), Germany (n = 25), Spain (n = 27), Sweden (n = 28), and the United Kingdom (n = 20). Baseline disease and demographic characteristics are shown in Table 1
.
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Patients’ Understanding of Exacerbation
Exacerbation is a term used commonly by physicians in all five countries studied: an exacerbation (United Kingdom); une exacerbation (France); eine Exazerbation (Germany); una exacerbación (Spain); en exacerbation (Sweden). However, patients had little or no understanding of the term. Approximately three fifths (59.2%; n = 74) of patients had never heard the word exacerbation or did not know what it meant, with some patients (8.8%; n = 11) confusing it with exasperation. Only one patient (0.8%) used the term exacerbation unprompted, and only two patients (1.6%) could explain that exacerbation meant a worsening of their condition.
When asked to state the single term they used to describe their worsening condition, patients most often said a chest infection (16.0%; n = 20), a crisis (16.0%; n = 20), or an attack (6.4%; n = 8). Some of the terms used by non-English-speaking patients could not be translated directly without losing some of their meaning; however, variations on certain terms were evident and generally consistent across countries. Terms concerning lung/chest infection or cold were most common, followed by variations on abnormal breathing, crisis, and attack (Fig 1 ).
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Global Impact of COPD and Exacerbations
Not surprisingly, patients reported feeling worse during exacerbations compared with stable COPD, and their physicians also recognized that the impact of COPD was worse during exacerbations than during stable disease (Fig 4
). Figure 5
shows that physicians considered patients’ physical impairment to be increased to a greater extent than their psychological impairment during their last documented exacerbation. The percentage of patients who were judged by physicians to be "a lot" or "extremely" physically or psychologically impaired during stable COPD was 32.0% (n = 40) and 26.4% (n = 33), respectively. During their last exacerbation, the corresponding proportion of patients was 72.8% (n = 91) and 47.2% (n = 59).
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Nearly 90% (n = 107) of patients reported that exacerbations had an influence on their ADL, with half of them needing additional help with certain tasks (particularly household chores, shopping, cooking, and "everything") during an exacerbation (Fig 6 ). For one half of the patients (47.2%; n = 59), all activities were stopped during an exacerbation, with some reporting that "... movement is hardly possible"; of these, 47 patients (37.6%) could do nothing at all.
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Discussion
It is established that exacerbations have a dramatic impact on disease progression, morbidity, mortality, and HRQL in patients with COPD.2 However, patients’ understanding and experience of exacerbations, and the impact of these events from their perspective, have until now remained largely unexplored. The results of this multinational, cross-sectional study of patient perceptions of their experience of COPD exacerbations reveal interesting findings that may be used to guide clinical practice and future studies.
To our knowledge, this is the first study to investigate patients’ understanding of COPD terminology. The results of the interviews demonstrate that the term exacerbation is rarely used or understood by patients who have frequent deterioration in their condition, and is often substituted with a shorter, more commonly used word. This observation highlights the importance of doctors using terms that are easily understood by patients (eg, heart attack instead of myocardial infarction). Standardizing the definition of an exacerbation4 would assist understanding of what constitutes an exacerbation and clarify the terminology used. The single term used most often by patients to describe an exacerbation, crisis, underscores the seriousness with which these patients view exacerbations.
Data collected on each patient in this study show that the frequency and duration of patient-defined COPD exacerbations vary markedly between individuals. According to physicians’ records (which probably rely heavily on patient recall), patients had an average of four to five exacerbations per year requiring some form of treatment or hospitalization. Patient recollections indicated that the average duration of an exacerbation was approximately 2 weeks. Moreover, patients said that they took, on average, 10 days to return to their usual level of activity following the start of an exacerbation. In more severe cases, patients reported that they had exacerbations that lasted for several months. Significantly, approximately 20% of patients believed that they had not returned to their previous state of health following an exacerbation. Despite being subject to recall bias, these findings are consistent with previous research152122 into the time course of and recovery after exacerbations in patients with moderate-to-severe COPD—even though these studies used different definitions of exacerbations—and suggest that the sample patient population in this study is fairly representative of the general moderate-to-severe COPD population. In a previous cohort study21 of 101 patients followed up prospectively for 2.5 years, the majority of patients recovered from their exacerbations within 35 days but 7.1% had not recovered by 91 days, and 3.4% experienced a further exacerbation before recovery from the previous exacerbation was complete. In a different study of patients who had infective exacerbations of chronic bronchitis, recovery of HRQL scores was found to be incomplete after an event, especially in those patients who experienced a second exacerbation during the study.22 This incomplete recovery may be attributable to a number of factors, including inadequate resolution of infections, malnutrition, side effects of therapy, or persistence of the cause of the exacerbation. The high frequency of exacerbations experienced by some COPD patients in this study is of concern and suggests either treatment resistance or that not all patients were receiving optimal treatment. Frequent exacerbations increase the risk of death and hospitalization, accelerate the decline in both lung function and HRQL, and dramatically increase costs associated with the disease.101323242526272829
Although exacerbations varied considerably between patients in the present study, most individuals recounted that they had predictable and reversible symptoms during self-defined exacerbations, and approximately two thirds were easily able to identify consistent warning signs. This observation is new and important, and suggests a window of opportunity and a potential role for self-management. Individualized action plans could be devised so that patients who experience warning signs can manage the exacerbation themselves and apply specific medical intervention at an early stage with the aim of improving outcomes.11 Indeed, data from this study show a patient preference for self-management, with more patients showing a willingness to undertake self-medication (presumably, in this instance, with bronchodilators, oxygen therapy [used for longer than usual], mucolytics, antibiotics, or corticosteroids) at the initial onset of an exacerbation rather than contact their doctor. Breathlessness and the nonspecific but often overlooked symptoms of fatigue or tiredness (important symptoms that relate directly to the degree of pulmonary impairment and deterioration in HRQL in patients with COPD30) were found to be the most common warning signs.
Despite their knowledge of warning signs and symptoms, patients said that they worried considerably about their next exacerbation, with many fearing serious outcomes, such as death (12% of patients) and suffocation (10%). These observations support preliminary findings from a smaller study (n = 16), in which some COPD patients perceived each illness crisis as a potential life threat.31 Some patients reported that they were unaware of an oncoming exacerbation; lack of warning signs may increase anxiety in these patients and result in an even greater impact on their daily lives. Improving recognition of the warning signs and encouraging patients to use preventative medication, and then to take appropriate action at the onset of an exacerbation, may help to alleviate such concerns.
Because this was a study involving patient self-reporting, one cannot be certain that all episodes described by patients were actually exacerbations of COPD, as would be defined by a physician. Patients were asked to describe episodes of breathing difficulties that required treatment or hospitalization; however, it is clear from patient responses that they also described episodes where neither intervention was received. These episodes may or may not have been exacerbations of COPD. The exacerbation profiles and consistent warning signs and symptomatology described by many patients do, nevertheless, suggest that at least the majority of these events were exacerbations. Moreover, physicians reported a high frequency of exacerbations requiring medical intervention (bronchodilators, and/or oral corticosteroids, and/or antibiotics, and/or oxygen therapy, and/or hospitalization) in case report forms. The results from this study were obtained from a select group of patients with frequent and often severe exacerbations, and the same findings may not apply in patients with less frequent and less severe exacerbations.
The patient interviews revealed that approximately one fifth of individuals in this study fail to inform their physician of a self-recognized acute deterioration in their condition, and therefore appropriate medical intervention may not have been received. There is evidence to show that early medical intervention improves outcomes (recovery time, HRQL, and risk of hospitalization) after COPD exacerbations and failure to report exacerbations increases the risk of emergency hospitalization.11 Additionally, reducing the frequency of exacerbations through preventative interventions has been shown to result in clinically significant improvements in HRQL.1819323334
Exacerbations are known to impair HRQL and daily activities in patients with COPD.1012131415 As expected, in this study patients reported feeling substantially worse during exacerbations compared to when their COPD was stable. Exacerbations imposed a considerable burden on patients by limiting their ADL, with one half of patients unable to do anything at all, and by reducing psychological well-being, with two thirds reporting detrimental effects on mood. These effects had adverse consequences for their personal and family relationships, leading to isolation and prevention of social activities. Although physicians gave similar assessments of the global impact of stable COPD on patients’ lives, they appeared to underestimate the impact of exacerbations, particularly on patients’ psychological health. They recognized that both physical and psychological impairments were increased during exacerbations, but they considered increases in physical impairment to be paramount, failing to appreciate the considerable changes to the patient’s emotional state (as observed in a previous study35). Such underestimation may contribute to undertreatment of COPD by health-care professionals, which may be widespread.36
In conclusion, the results of this multinational study show that patients with both subjective and objective features of COPD and frequent exacerbations that require treatment have little or no understanding of the term exacerbation. Exacerbations occur frequently in patients with moderate-to-severe COPD, and patient recollections suggest that symptoms vary greatly between patients but remain relatively uniform and recognizable for each individual. Indeed, the majority of patients report that they have warning signs that alert them to the onset of an exacerbation. These events appear to have a significant impact on the individual’s physical and psychological well-being, with nonrespiratory symptoms that are often overlooked being common, such as tiredness, malaise, and low mood; some patients believed that they had had an apparent irreversible decline in their overall condition. Doctors may have a tendency to underestimate the impact, particularly the psychological impact, of exacerbations on patients. Some patients do not inform their doctor when their condition worsens, and a substantial proportion of patients appear to prefer to self-medicate at the onset of an exacerbation. There is often much associated anxiety both during and between exacerbations, with a considerable proportion of patients fearing death or suffocation. These findings suggest a need for improved doctor/patient communications in addition to enhanced awareness of symptoms/warning signs, the impact (particularly psychological impact) that exacerbations have on patients, and of the specific actions that individual patients need to take at the onset of an exacerbation. Interventions such as these may improve the prevention and management of COPD exacerbations, and thereby reduce the burden of this disease.
Acknowledgements
This study was devised by the authors and undertaken by Mapi Values, Lyon, France, with the support of AstraZeneca R&D, Lund, Sweden. Interpretation and evaluation of the results were by all of the authors, and Mark Richardson of Adelphi Communications Ltd, Macclesfield, UK, provided medical writing support.
Footnotes
Abbreviations: ADL = activities of daily living; HRQL = health-related quality of life; VAS = visual analog scale
Received for publication June 21, 2005. Accepted for publication January 4, 2006.
References
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