Background: Spirometry for early detection of chronic obstructive pulmonary disease (COPD) and smoking cessation is criticised because of the potential negative effects of labelling with disease.
Aim: To assess the effects of opinions of smokers with mild to moderate COPD on the effectiveness of spirometry for smoking cessation, the justification of early detection of airflow limitation in smokers and the impact of confrontation with COPD.
Design: Qualitative study with data from a randomised controlled trial.
Setting: General population of Dutch and Belgian Limburg.
Methods: Semistructured ethical exit interviews were conducted with 205 smokers who were motivated to quit smoking and had no prior diagnosis of COPD but were detected with airflows limitation by means of spirometry. They received either (1) counselling, including labelling with COPD, plus with nortriptyline for smoking cessation, (2) counselling excluding labelling with COPD, plus nortriptyline for smoking cessation or (3) care as usual for smoking cessation by the general practitioner, without labelling with COPD.
Results: Of the participants, 177 (86%) agreed or completely agreed that it is justified to measure lung function in heavy smokers. These participants argued that measuring lung function raises consciousness of the negative effects of smoking, helps to prevent disease or increases motivation to stop smoking. Most of the 18 participants who disagreed argued that routinely measuring lung function in smokers would interfere with freedom of choice.
Conclusions: Labelling with disease is probably a less important issue in the discussion about the pros and cons of early detection of COPD.
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Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease that is characterised by airflow limitation that is not fully reversible.1 It is currently the fifth leading cause of death worldwide,2 and a further increase in mortality is predicted in the coming decades.3 Smoking is by far the most important risk factor for COPD, and smoking cessation is the single most effective way to reduce the risk of developing the disease and to affect the outcome in patients at all stages.4 5 Because of the irreversible and progressive nature of COPD, early intervention is important. However, COPD is usually underestimated by patients and by healthcare providers, because many patients who have it do not present with respiratory symptoms, and those who have it are not always diagnosed as such.6 An issue of debate is the use of spirometry for early detection of COPD.7 8 9 10 Its ethical aspects are the subject of this paper.
Labelling with disease—confronting healthy subjects with a previously undetected or unrecognised disease status—has long been an issue of debate in medicine. Usually the debate has focused on the potential adverse effects of labelling, ranging from the ethical aspects of screening for an incurable disease, thereby advancing the onset of life years afflicted by it, to the risks of stigmatisation and exclusion involved in genetic screening programs,11 to the impact that diagnosis of a contested illness such as chronic fatigue syndrome might have.12
With regard to early detection of COPD by means of spirometry, several advantages and disadvantages have been debated. A potential advantage is that confronting smokers with the results of spirometry may motivate more of them to quit. While most smokers acknowledge that smoking is dangerous, many play down their own perceived risk of disease or deny or avoid information about the dangers of smoking in order to reduce cognitive dissonance.13 14 15 16 Spirometry may be used as a tool to confront the smoker with objectively obtained evidence of personal susceptibility to the hazards of smoking. Furthermore, providing smoking cessation treatment in the presence of smoking-related disease seems to be a more feasible approach for many healthcare providers. According to international guidelines,17 18 healthcare providers should offer all smokers smoking cessation treatment, independent of whether they have an underlying smoking-related disease or not. However, many physicians do not believe that this is effective or practicable.19 They usually limit such treatment to patients who have smoking-related symptoms.20 Therefore, spirometry may offer more health professionals a window of opportunity to address smoking cessation in their patients.
Several counterarguments for early detection of COPD by means of spirometry have been proposed. First, there is no convincing evidence to date that confrontation with spirometry increases smoking cessation.21 22 In addition, there may be a potentially counterproductive effect of communicating negative test results to smokers.23 Smokers with normal lung function might use this result as a message that they are not susceptible to the effects of smoking. A second counterargument is that widespread spirometry may lead to overtreatment in patients with mild and non-disabling symptoms.24 25 The prescription of expensive inhaled medication results in considerable treatment costs and may also prevent patients from using non-pharmacological treatments that are known to be effective, in particular smoking cessation. Another counterargument is that the act of labelling itself may lead to unnecessary patient worry and stigmatisation; individuals with COPD may experience negative reactions due to the perceived self-inflicted nature of their disease (ie, their own smoking behaviour).26 This process may lead to feelings of embarrassment and ultimately social isolation in affected individuals.26
Most of the discussion in the literature about the effects of labelling is hypothetical, since empirical data regarding patients’ perspectives in this debate are rare. The major aim in this paper is therefore to let the smokers speak for themselves. As part of a randomised controlled trial on early detection of airflow limitation and subsequent smoking cessation treatment,27 we conducted semistructured ethical exit interviews on this subject with the study participants. We aimed to assess the opinions of these participants on the effectiveness of spirometry for smoking cessation, the justification for early detection of airflow limitation in smokers and the impact of confrontation with a diagnosis of COPD.
We used data from a randomised controlled trial on confrontational counselling for smoking cessation given to patients with previously undiagnosed COPD. A detailed description of the trial protocol has been published elsewhere.27 In brief, current smokers aged 35 to 70 years who were motivated to quit smoking were invited to take part in a study on individual counselling and medication for smoking cessation. Participants were excluded if they reported having COPD, chronic bronchitis, asthma or asthmatic bronchitis. The participant information sheet did not include any information about early detection and confrontation with a diagnosis of COPD or about the differences in counselling between the experimental and the control group. The design we used was adapted from Zelen’s design,28 29 which may be particularly useful when evaluating the full, unbiased impact of screening interventions.30 Subjects were eligible if they had mild or moderate airflow limitation, defined as post-bronchodilator FEV1/FVC <70% in combination with post-bronchodilator FEV1 ⩾50% of predicted value.1 The results of spirometry were not discussed at that moment. Subjects with severe or very severe COPD were not included but were referred to their general practitioner. The trial was approved by the medical ethics committee of Maastricht University Medical Centre and registered in the Netherlands Trial Register (ISRCTN 64481813).
Eligible smokers were randomised to an experimental group and two control groups. Participants from both the experimental group and control group 1 received four weekly 40-minute counselling sessions delivered by a respiratory nurse, based on a national protocol for smoking cessation treatment.31 In addition, participants from both groups received an equally dosed 7-week pharmacological treatment with nortriptyline, initiated on the day of the first counselling session. Specific elements of “confrontational counselling”32 were added to the counselling protocol in the experimental group, distinguishing the treatment from that in control group 1: this involved discussing the results from their spirometry and the prognosis of COPD, and challenging irrational beliefs about smoking. Thus, only subjects from the experimental group were confronted with their spirometry results and labelled with the disease COPD. Participants from control group 2 were referred to their own general practitioner for primary “care as usual” for smoking cessation, which involves the use of a protocol for low-intensity health education and promotion.33
All participants were followed up for 12 months after their target quit date. During the 12-month follow-up visit, a research assistant conducted a semistructured ethical exit interview on the issue of early detection of COPD and confrontation with spirometry. The interview consisted of four statements (box 1) the assistant read out to the participant. The participant was asked to rate the statement on a 5-point Likert scale ranging from “completely disagree” (score 1) to “completely agree” (score 5). Subsequently, the assistant stimulated the participants to elaborate on their opinions and to formulate arguments. The assistant wrote down all arguments in the participants’ own words, providing transcripts of “shorthand descriptions” for the data analysis.
Box 1 Statements on the issue of early detection of COPD and confrontation with spirometry
Statement 1: The fact that my lung function was measured at the start of this study has had a favourable effect on my attempt to quit smoking.
Statement 2: It is justifiable to measure the lung function of people who have been heavy smokers for a long time.
Statement 3: The respiratory nurse was right to confront me with this lung disease (COPD) during the study.
Statement 4: The fact that the pulmonary nurse discussed the lung function measurement with me in order to confront me with COPD has helped me in my attempt to quit smoking.
Baseline characteristics were measured by questionnaire. Nicotine addiction was measured with the Fagerström Test for Nicotine Dependence.34 Three self-constructed items were used to measure health concerns (table 1).
The quantitative data from the Likert scales were used to calculate means and standard deviations. For the statistical testing, participants scoring 1 (“completely disagree”) and 2 (“disagree”) were combined into one group and those scoring 4 (“agree”) and 5 (“completely agree”) into another group (participants scoring 3 “neutral” were omitted). We found it justifiable to omit “neutral” responses because they were rare (1–6%) and because we wanted to compare the two opposing viewpoints. χ2 tests were used to test statistical differences in the proportions of subjects who agreed versus disagreed. All these analyses were performed in SPSS.
The qualitative data were analysed based on the grounded-theory method as developed by Glaser and Strauss35 and further extended by Strauss and Corbin.36 37 Grounded theory uses the constant comparative method of data analysis. In this approach, coding is used to conceptualise data into patterns or concepts.38 Participants’ arguments were extracted from the transcripts, analysed and finally aggregated into six clusters: freedom of choice, consciousness-raising, regular health check-ups, prevention of disease, motivation to quit smoking, and other. All analyses were performed by two researchers (DK and RV). These two investigators brought different skills and expertise to the analysis, benefiting the analysis and interpretation from divergent perspectives.38
A total of 296 participants were included in the trial in the period from February 2005 to January 2007 (fig 1). Of those, 205 (69%) completed the 12-month follow-up measurement, 85 of 116 participants (73%) randomised to the experimental group, 80 of 112 (71%) randomised to control group 1 and 40 of 68 (59%) randomised to control group 2. The statistical test for difference between numbers lost to follow-up across the three groups was not significant (χ2 = 4.60, df = 2, p = 0.100). The baseline characteristics of the participants who entered the analyses are shown in table 1. These did not differ from the characteristics of the full sample of 296 participants who were randomised. Responses to the three questions about health concerns showed that, on average, participants were unsure about having a smoking-related disease (health concern 1), but that they were worried about getting such a disease (health concern 2) and that they found it very important to reduce their risk of getting such a disease (health concern 3).
Statement 1: Does measuring lung function have a favourable effect on the attempt to quit smoking?
Ninety-four participants (46%) agreed or completely agreed that measuring lung function positively influenced their attempt to quit smoking (fig 2). Ninety-seven participants (47%) disagreed or completely disagreed and 13 (6%) were neutral. More participants from the experimental group (61%) than from control group 1 (33%) or control group 2 (51%) agreed (table 2).
Of the 94 participants who agreed with the statement, 16% (n = 15) argued that confrontation with objective evidence of respiratory illness influenced their attempt to quit. This included a total of two persons from control group 1 and control group 2 who stated that the lung function measurement increase their awareness. Another 12% (n = 11) argued that the measurement confirmed a presumption that something was wrong with their lungs, and 18% (n = 17) that they had difficulties with performing the lung function test. Another frequently mentioned argument was taking part in a serious research project as a reason to quit (n = 17, 18%).
Of the 97 participants who disagreed with statement 1, 57% (n = 55) argued that spirometry itself without discussing the results did not have an effect. The proportion of participants using this argument was higher in control group 1 (34%) than in the experimental group (20%) or control group 2 (28%). In control group 1, the respiratory nurses were instructed not to discuss the results of the spirometry during the counselling session.
Statement 2: Is it justifiable to measure lung function in heavy smokers?
One hundred and seventy-seven participants (86%) agreed or completely agreed that it is justified to measure lung function in smokers (fig 3). Eighteen participants (9%) disagreed or completely disagreed and 9 (4%) were neutral. Participants who agreed were more likely to be smokers, that is, participants who did not succeed in quitting smoking during the 12-month follow-up (table 2). A selection of quotes relating to frequently mentioned arguments is presented in table 3.
Of the 18 participants who disagreed with statement 2, 89% (n = 16) argued that routinely measuring lung function in smokers would interfere with one’s freedom of choice.
Statements 3 and 4: what impact does confrontation with COPD have?
Statements 3 and 4 refer only to participants from the experimental group. Solely in this group, participants were confronted with the results from spirometry and the fact that they have airflow limitation. Of the 85 participants who entered the analysis, 83 (98%) agreed that it was justified that the respiratory nurse confronted them with COPD, whereas only one participant disagreed (1%). Also, 78 participants (92%) agreed that the confrontation with spirometry helped them to make an attempt to quit. Five participants (6%) disagreed and one (1%) was neutral. These answers were not associated with self-reported smoking status at follow-up, but more participants with a worse lung function (lower half: FEV1<84.1%) stated that confrontation with spirometry motivated them to stop smoking (table 2).
Within the framework of a randomised controlled trial on smoking cessation treatment in smokers with previously undiagnosed COPD, and with data from semistructured exit interviews with 205 participants, we performed an analysis of ethical issues regarding early detection of airflow limitation and confrontation with COPD. We provided new empirical data of patients’ perspectives about these issues. The vast majority of participants found it justified to measure lung function in smokers and to confront smokers with the results from spirometry. This opinion was supported by arguments about consciousness-raising, prevention of disease, regular health check-ups and motivation to stop smoking.
Ethical concerns have been raised with regard to early detection of COPD, basically because widespread spirometry would be likely to label a large number of individuals with disease. The major aim of our analyses was to let smokers who experienced early detection and confrontation with COPD speak for themselves. The very few smokers who did not find it justified to measure lung function in smokers saw this approach as an interference with freedom of choice. A potential disadvantage of early detection of COPD—overtreatment of patients with mild and non-disabling symptoms—was not mentioned by this group. This is probably because the prescription of inhaled medication for symptomatic treatment was not an option in this study; the treatment after early detection was limited to smoking cessation, which still is the only effective treatment to reduce accelerated decline of lung function in COPD patients. Another potential disadvantage—negative consequences of stigmatisation of individuals with COPD—was also not put forward as an argument. A stigma is often associated with diseases that lead to serious observable consequences.26 The participants from this study, however, had mild to moderate COPD. It may be that they did not experience consequences of stigmatisation because their respiratory symptoms (coughing, shortness of breath and sputum production) were not always observable to others.
The majority of smokers were in favour of measuring lung function in smokers in general, basically because it helps to prevent disease and allows early intervention, and because it might motivate smoking cessation due to consciousness-raising about the negative effects of smoking. This suggests that labelling with disease is not found as problematic by the people to which it applies (the smokers with mild to moderate COPD) as by some authors.21 22 24 39 The number of arguments used between the three intervention groups were about the same. The fact that the experimental group (the only group that was confronted with declined lung function as part of the smoking cessation counselling) did not use more arguments than the two other groups indicates that there was no learning effect or, formulated more sharply, no effect of medicalisation.
Less than half of all participants agreed that measuring lung function positively influenced their attempt to quit, regardless of smoking status. However, within participants from the experimental group, nearly everybody agreed that confrontation with lung function was helpful for their attempt to quit. Interestingly, relatively more smokers with worse lung function agreed, which may indicate a greater susceptibility to confrontational counselling in smokers with more advanced COPD. These viewpoints and the arguments used to underpin them suggest that merely measuring lung function does not promote smoking cessation, but that confrontation with lung function should be integrated into a smoking cessation counselling programme. This confirms our hypothesis that altering irrational cognitions that smokers use to legitimatise their behaviour is not likely to be achieved by brief advice.32 In a mediation analysis of the primary efficacy data from this smoking cessation trial, we showed that confronting smokers with COPD resulted in increased risk perception and self-efficacy and in decreased use of self-exempting beliefs (ie, risk denial), and that these changes in cognitions were associated with short-term abstinence from smoking.40 However, there was no difference in long-term abstinence between smokers who were confronted with COPD and smokers who were not.41 Thus, our study results do not provide evidence to support the potential advantage of early detection of COPD leading to higher smoking cessation rates.
The smokers participating in this trial were all characterised by a high motivation to quit smoking, by the presence of concerns about getting a smoking-related disease in the future and by the urge to reduce that risk. This is important when interpreting the results of this study, because smokers who are not motivated to quit smoking or who are not concerned about their health are likely to have different attitudes towards early detection and labelling with disease. We do think, however, that our study population represents an important group of people, as most smokers want to quit smoking, many of them because of health concerns. We created a clinical context for participants from the experimental group and control group 1 in which they were treated individually and with an intensive interaction with a respiratory nurse, which does not reflect the usual current care for smoking cessation. Thus, this paper does not give an answer as to whether smokers find a more population-based, screening approach of COPD ethically acceptable. This paper does also not represent the views of ex- or non-smokers. However, early detection of COPD in this group is probably not ethical, because smoking cessation is the only effective therapy for progression of the disease, leaving not much to offer to those who have already quit smoking (except medication to relieve symptoms).
We are aware of the limitations of our study, particularly using short exit interviews and shorthand descriptions of the answers smokers provided in these sessions delivered by respiratory nurses—constraining more in-depth qualitative research, which is impossible because of the demands of performing such a clinical trial. About 30% of the participants who were randomised at the beginning of the trial were lost to follow-up after 12 months. Though the characteristics of the sample that entered this analysis were comparable with the full sample of randomised participants, it may be that participants who were lost to follow-up had different attitudes. We suspect that smokers who relapsed to smoking were less likely to complete the follow-up visits, but smoking status was not an important factor associated with the responses. Despite these limitations, we hope that our study provides interesting data on the ethical issues involved and contributes to the ethical debate on confrontational forms of counselling such as, in our case, the early detection of COPD and on the confrontation with such a diagnosis in order to change lifestyle practices.
We conclude that smokers with mild to moderate COPD find measurement of lung function in smokers and labelling with COPD justifiable for the sake of early detection and prevention of disease. It may also facilitate smoking cessation, but only in the context of an approach that includes individual counselling. Labelling with disease is probably a less important issue in the discussion of the pros and cons of early detection of COPD.
The authors gratefully acknowledge the contributions of Onno van Schayck, Geertjan Wesseling (project leaders), Kitty van der Meer (telephonic screening, logistics), Arja van de Voorde, Ellen de Goeij (spirometry), Marleen Vaassen, Hilde Bastiaens, Rianne Romers, Tim Sales, and Karin Frambach (respiratory nurses).
Funding This study was funded by grants from the Dutch Asthma Foundation, Partners in Care Solutions for COPD (an initiative of CAPHRI School for Primary Care and Public Health, Boehringer Ingelheim, and Pfizer) and Maastricht University Medical Centre.
Competing interests None.
Ethics approval The trial was approved by the medical ethics committee of Maastricht University and Maastricht University Hospital and registered at the Netherlands Trial Register (ISRCTN 64481813). The work was performed at Maastricht University Medical Centre, The Netherlands.
Provenance and Peer review Not commissioned; externally peer reviewed.
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