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Perception of the Role and Potential Side Effects of Inhaled Corticosteroids Among Asthmatic Patients* Louis-Philippe Boulet, MD, FCCPf and fear of untoward side effects Background: Misunderstanding of the role of asthma medication in to reduce compliance therapy, potentially resulting poor asthma control and increased may risk of severe asthma events. Methods: We report the results of a recent Canadian survey of 603 asthmatic patients recruited from the general population, aimed at determining their perception of the role and potential side effects of inhaled corticosteroids (ICS). Results: The survey revealed that a large proportion of asthmatic patients do not understand the role of their medications and have many misconceptions and fears in regard to ICS, reducing their willingness to use them. Among the most common fears are those concerning troublesome side effects, particularly in regard to corporeal image, bone density, and a reduction in efficacy of medication over time. More than half of the population said they were very or somewhat concerned using ICS on a regular basis; two thirds of patients had not discussed their concerns about ICS with their physicians or other health-care professionals. Finally, in a large number of asthma patients, asthma was not adequately controlled, according to recent asthma consensus guidelines. Conclusions: These observations stress the importance for those involved in asthma care of questioning patients about their understanding of the role of asthma medications, particularly ICS, their fears and misconceptions, and what they consider to be adequate asthma control, in order to provide appropriate education and counseling. (CHEST 1998; 113:587-92) Key words: asthma; asthma treatment; compliance; education; inhaled corticosteroids; patients' perception disease, still responsible for Asthma Canada significant morbidity and mortalityconsidered that other countries.13 It is a common in is in as generally untoward consequences of asthma could be avoided by preventive measures, individualized therapy, and education, as indicated pharmacologic in recent national and international guidelines on asthma management.46 Unfortunately, asthma is still often insufficiently controlled, resulting in increased health-care use and morbidity. Two of the factors involved in poor asthma control are deficiency in recognizing asthma severity and suboptimal treatment, this last often related to reduced compliance.78 Adherence most to therapy varies widely according to studies, *From the Centre de Pneumologie de l'Hopital Laval, Universite Laval, Sainte-Foy, Quebec, Canada. Copies of the questionnaire used in this study are available from the author on request. Glaxo Wellcome Canada. Supported byreceived February 27, 1997; revision Manuscript tember 10. accepted Sep¬ Reprint requests: Louis-Philippe Boulet, MD, FCCP, Hopital Laval, 2725, Chemin Sainte-Foy, Sainte-Foy, Quebec, Canada G1V 4G5 ranging from about 20 to 70% in different chronic conditions such as asthma.812 Nonadherence to or misuse of therapy often results from inadequate knowledge or understanding of the disease and its treatment, psychosocial and economic factors, of side complexity of the treatment, occurrence commu¬ insufficient and effects, patient/care giver nications.1013 A poor understanding of asthma and the role of medication may lead not only to insufficient intake of drugs, such as bronchial anti-inflamma¬ tory agents, but also to overuse of others, such as P2-adrenoceptor agonists.141516 Asthma is an airway inflammatory disorder, and inhaled corticosteroids are considered to be the mainstay of its treatment, while P2-adrenoceptor agonists primarily play a role in the control of intermittent symptoms.461718 Doses of inhaled corticosteroids 1,000 fxg daily of beclomethasone in adults and 400 to 800 fig in children are considered safe, and even higher doses are preferable to poor control of asthma.18 Never¬ have different views on some of the < theless, patients p2-adrenoand and corticosteroid use, persisting ceptor agonist CHEST/113 73/MARCH, 1998 Downloaded From: http://publications.chestnet.org/pdfaccess.ashx?url=/data/journals/chest/21761/ on 04/28/2017 587 corticophobia may be at least partly responsible for reduced compliance to this therapy.19 To better understand how to provide adapted and efficient counseling to asthmatic patients, we should of asthma therapy, particu¬ analyzein their perception to medications such as inhaled corti¬ larly regard costeroids, and understand their fears and concerns about these agents. There are still, however, few studies addressing these particular issues. A Cana¬ dian survey of asthmatic patients was recently con¬ ducted to assess perceptions regarding the role and potential side effects of asthma medications. The primary objective of this research was to under¬ stand the asthma patient's attitude pertaining to inhaled corticosteroids. A secondary objective was to obtain a general profile of the Canadian asthmatic population. Materials and Methods Subjects A national telephone survey was conducted throughout Canada, aiming at interviewing adults with asthma, with each province or region represented at its true proportion of the Canadian population. Within each province, half of the interviews were conducted in urban areas and half in rural areas. Partici¬ study if they were 16 years or older and had a physician's diagnosis of asthma, reactive/hyperreactive or irritable airways. To recruit approximately 600 patients fulfilling the inclusion criteria and completing the interviews, a total of 11,315 people were interviewed; 137 were disqualified based on employment in a market research or pharmaceutical organizations, 10,095 did not have asthma, 328 had asthma but were younger than 16 years of age, and 155 qualified but refused to participate in the study. Overall, initial refusal to take part to the interview was 24% and only 1% decided not to complete the interview part way through. pants qualified for the The questionnaire included questions about various aspects of corticosteroid therapy, particularly relating to the perceived modes of action and side effects of those agents. The general profile of the enrolled asthmatic patients was assessed in regard to years diagnosed with asthma, medication usage and dosing, physician managing asthma, severity of asthma, frequency of Emergency Department visits due to asthma, and sources of patient information. Data Results are described as means for the whole group of patients and, in some cases, for subgroups, such as those currently using inhaled corticosteroids. Differences were considered significant at the 95% level of confidence. Results reported for the whole sample are correct to ±4% margin of error, 19 times out of 20. Results The average patient's profile is shown in Table 1. They usually had suffered from asthma for many years (mean, 13 years) and most took inhaled salbutamol on demand. Thirty-nine percent (n=235) had used regular or intermittent inhaled corticosteroids in the past 12 months. Of those, 75% had used inhaled beclomethasone (42% high-dose formula¬ tion, 33% low-dose formulation or unspecified) and 25% had used inhaled budesonide. Half (48%) con¬ sidered their condition to be mild, 38%, moderate, and 14% severe. Inhaled corticosteroid users tended to consider their condition to be more serious. Fifty-six percentin said that asthma was related to allergies (57% corticosteroid users). Overall, each had visited an Emergency Department on (mean) 15 occasions since asthma was diagnosed (Table 1). Table 1.Patient Population Profile (n=603) Methods Interviews were conducted from mid- to late-September, Characteristic 1995, English or French. Camelford Graham was the research firm commissioned for the study. They were supported by Telepoll Canada Inc, which specializes in data collection. Camelford Graham developed the questionnaire, supervised all fieldwork, processed the data, and were involved in data analysis. The in Analysis questionnaire was pretested twice: once formally with field staff and again live with qualified respondents. This process allowed the questionnaire to be checked for proper flow or any potential problem areas regarding possible misinterpretation or respon¬ dent confusion. Based on the pretest, necessary adjustments were made to produce the finalized version of the questionnaire to be used in field. Continuous monitoring of each interviewer as¬ signed to the study was conducted. Approximately 20% of interviews were randomly monitored. All interviewers were briefed in advance and read the questions exactly as they were worded but did not read the list of possible responses that are shown. They listened to the response and determined which code best fitted their response. If there was not a good fit with any of the precodes provided, the interviewer recorded the partici¬ pant's response verbatim. % of Subjects* Men/women 34/66 Age, yr 16-30 30-60 60+ Asthma reported Time since <5 6-10 >11 37 44 19 56 as allergy induced diagnosis, yr (mean, 13 yr) 36 22 42 Self-assessment of asthma severity Mild Moderate Severe No. of visits to the emergency was diagnosed 48 38 14 dept since asthma 1 to 9 10-19 20+ ^Percent of the total 66 10 24 population studied. 588 Downloaded From: http://publications.chestnet.org/pdfaccess.ashx?url=/data/journals/chest/21761/ on 04/28/2017 Clinical Investigations From the whole group, 293 were followed up by a general practitionner, 51 by a specialist, 65 by both, and 194 had no regular follow-up. Patients followed up by a specialist or both had more severe asthma patients believed that inhaled corticosteroids could cause weight gain, build huge muscles, cause infec¬ tions, make bones susceptible to fractures, or affect growth. Inhaled corticosteroid users had a more positive attitude toward corticosteroids, recognizing that they were useful to treat asthma. They harbored fewer misconceptions or fears than did the nonusers. Agreement with most of the attributes concerning safety and specific side effects increased with sever¬ ity of asthma. One of the common misconceptions or fears was the impression that higher doses would have to be used over time to match the effectiveness previously experienced (38%). This is in keeping with answers to other questions related to the perception that inhaled corticosteroids could become less effective when used on a long-term basis (36%). Misconcep¬ tions regarding possible loss of efficacy after longterm use remained constant across mild, moderate, and severe sufferers. Forty-six percent of patients agreed with the state¬ ment indicating a reluctance to take inhaled cortico¬ steroids on a regular basis. Among those claiming that they were not using inhaled corticosteroids, when asked about their willingness to fill a prescrip¬ tion of corticosteroids, 18% indicated that they would definitely fill this prescription, 38% said def¬ and 37% would probably or initely or not probably, fill this definitely prescription. The positive intent to fill the prescription increased slightly with age (33% between 16 and 19 years old and 40% older than 40 years old). Men expressed a greater likeli¬ hood to use inhaled corticosteroids than women (64% vs 46%). Sixty-five percent of patients (80% of those using inhaled corticosteroids within the past 12 months) mentioned that they would be interested in using a newer and safer inhaled corticosteroid. Most patients claimed that they had not discussed their concerns about inhaled corticosteroids with their physician or other health-care professionals (75%). Thirty-one percent of asthmatic patients in¬ dicated that they were not aware that inhaled corti¬ costeroids existed for asthma treatment, as a reason for not discussing them with their physician. When they had discussed those concerns, most of them had than those followed by a general practitioner. Respiratory Symptoms Roughly two thirds of asthmatic patients stated some of the following symptoms they experienced once a week or more often: coughing, wheezing, breathlessness, and early morning chest tightness. Most of these symptoms were considered to be more than mild in close to two thirds of the subjects (Table 2). Coughing and wheezing were the symptoms experienced most frequently. Respiratory symptoms were regularly present in at least half of the subjects; 26% experienced nighttime awakenings once a week or more and 38%, early morning chest tightness 3 and (Table 4). Understanding the Role of Asthma Medications Table 5 provides a summary of the answers to the key questions on perception of the role of inhaled corticosteroids. of the main One observations of this that asthma sufferers confused the survey many two chief categories of agents, bronchodilators and anti-inflammatory agents. They did not correctly understand the role of inhaled corticosteroids in the treatment of asthma or how to use them properly; the most common misconception was reflected by the fact that 43% believed that corticosteroids opened the airways and relieved constriction as do bronchodilators while only 22% mention that they reduced inflammation or swelling of the airways. was Concerns About Inhaled Corticosteroids Table 6 summarizes the primary concerns expressed about inhaled corticosteroids. More specifi¬ cally, 53% of the patients (47% of inhaled cortico¬ steroid users) said they were very or somewhat concerned about using inhaled corticosteroids. Their concerns included the fear of side effects (59%), althoughif 39% recognized that they were usually minor the drugs were used as prescribed. Many Table 2.Evaluation of Asthma Symptom Severity Mild Moderate Severe * Percent of subjects Coughing Symptom Severity* Chest Coughing Up Phlegm Tightness Breathlessness Wheezing Nighttime Wheezing 35 36 45 18 26 50 21 30 45 23 33 45 19 26 43 28 46 17 rating the various reported symptoms as mild, moderate, or severe. CHEST / 113 / 3 / MARCH, 1998 Downloaded From: http://publications.chestnet.org/pdfaccess.ashx?url=/data/journals/chest/21761/ on 04/28/2017 589 Table 3.Frequency of Symptoms* Breathlessness Without Coughing Wheezing Once a week or more 51 44 Between once a week and once every 2 wk 9 8 Between once every 2 wk and once every 4 wk Between once a month and once every 3 mo Less frequently than every 3 mo 11 12 Do not experience that symptom 11 11 ^Percent of patients 11 36 9 8 6 11 30 1310 9 37 7 6 10 13 26 38 6 9 33 26 5 5 7 11 46 reporting this frequency for a given symptom. Numbers may not exactly equal 100 as decimals are omitted. with their family physician (81%) and most felt (75%) that their concerns were eased through those discussions. Finally, overall, there were no significant differ¬ ences in the answers to the various questions on inhaled corticosteroids between patients from rural areas and those from urban areas. done Exertion Early Morning Coughing Chest Up Phlegm Nighttime or Mucus Tightness Awakenings so Discussion There are few observations in the medical litera¬ on the perception of asthma medication, partic¬ ularly in asthmatic patients recruited from the gen¬ eral population. Those attending asthma clinics may have had additional information through their regu¬ lar follow-ups or participation in studies. It is there¬ fore of interest to look at the results of such an extensive survey of the general population. This survey demonstrated that knowledge of asthma medications by asthmatic patients is often poor, with many confusing what is currently consid¬ ered to be the two main categories of drugs, bron¬ chodilators and anti-inflammatory agents. Further¬ more, fears and misconceptions about inhaled corticosteroids are quite frequent among the asth¬ matic population, the two most common being about untoward side effects and a reduction in efficacy with time. Most of the subjects questioned had not discussed those fears with their physicians or other health-care professionals. Furthermore, although this was not specifically addressed, answers to the ture questionnaire suggested that evaluation of asthma by the asthmatic patient was frequently control inadequate, and that asthma-related morbidity was significant. We may question the validity of the diagnosis of asthma in the present study, although in all cases it was made by the physician, and a large part of the studied was young, so that confounding population asthma with COPD was unlikely. Furthermore, a large proportion of subjects had chronic symptoms typical of asthma (mostly cough, wheezing, chest and breathlessness) and had had asthma tightness, medication prescribed. Even when environmental measures are appropri¬ ate, many asthmatic subjects still required some form of asthma medication. Inhaled corticosteroids are considered the mainstay of pharmacologic treat¬ ment of asthma, and in most asthmatic subjects, asthma is controlled by doses that are considered safe and likely induce no or minimal side effects.18 It has been well established that inhaled corticoste¬ roids, used judiciously at the minimal dose required in association with are preventive measures, Table among 5.Perception of the Role of Inhaled * Corticosteroids Ever Used Past 12 mo Inhaled Corticosteroid Corticosteroids Users X Opens the airways- -relieve (n=272) (n=235) 43 41 22 24 14 16 constriction Table 4.Frequency of Respiratory Symptoms Coughing Wheezing Breathlessness without exertion Coughing up phlegm or mucus Early morning chest tightness Nighttime awakenings Symptoms % of Patients Experiencing Those Symptoms Once a Week or More 51 44 38 37 36 26 / Reduces inflammation/swelling of the airways /Prevents asthma attacks 11 12 asthma attack 7 /Gets asthma symptoms under control 3 3 X Builds up/strengthens lungs 11 12 Don't know *Checkmark (/) is considered a good answer; "X" is considered a false answer. Answers are respectively true or false according to X Relieves current an knowledge. 590 Downloaded From: http://publications.chestnet.org/pdfaccess.ashx?url=/data/journals/chest/21761/ on 04/28/2017 Clinical Investigations Perception of the Role and Potential Side Effects of Inhaled Corticosteroids Among Asthmatic Patients* Louis-Philippe Boulet, MD, FCCPf and fear of untoward side effects Background: Misunderstanding of the role of asthma medication in to reduce compliance therapy, potentially resulting poor asthma control and increased may risk of severe asthma events. Methods: We report the results of a recent Canadian survey of 603 asthmatic patients recruited from the general population, aimed at determining their perception of the role and potential side effects of inhaled corticosteroids (ICS). Results: The survey revealed that a large proportion of asthmatic patients do not understand the role of their medications and have many misconceptions and fears in regard to ICS, reducing their willingness to use them. Among the most common fears are those concerning troublesome side effects, particularly in regard to corporeal image, bone density, and a reduction in efficacy of medication over time. More than half of the population said they were very or somewhat concerned using ICS on a regular basis; two thirds of patients had not discussed their concerns about ICS with their physicians or other health-care professionals. Finally, in a large number of asthma patients, asthma was not adequately controlled, according to recent asthma consensus guidelines. Conclusions: These observations stress the importance for those involved in asthma care of questioning patients about their understanding of the role of asthma medications, particularly ICS, their fears and misconceptions, and what they consider to be adequate asthma control, in order to provide appropriate education and counseling. (CHEST 1998; 113:587-92) Key words: asthma; asthma treatment; compliance; education; inhaled corticosteroids; patients' perception disease, still responsible for Asthma Canada significant morbidity and mortalityconsidered that other countries.13 It is a common in is in as generally untoward consequences of asthma could be avoided by preventive measures, individualized therapy, and education, as indicated pharmacologic in recent national and international guidelines on asthma management.46 Unfortunately, asthma is still often insufficiently controlled, resulting in increased health-care use and morbidity. Two of the factors involved in poor asthma control are deficiency in recognizing asthma severity and suboptimal treatment, this last often related to reduced compliance.78 Adherence most to therapy varies widely according to studies, *From the Centre de Pneumologie de l'Hopital Laval, Universite Laval, Sainte-Foy, Quebec, Canada. Copies of the questionnaire used in this study are available from the author on request. Glaxo Wellcome Canada. Supported byreceived February 27, 1997; revision Manuscript tember 10. accepted Sep¬ Reprint requests: Louis-Philippe Boulet, MD, FCCP, Hopital Laval, 2725, Chemin Sainte-Foy, Sainte-Foy, Quebec, Canada G1V 4G5 ranging from about 20 to 70% in different chronic conditions such as asthma.812 Nonadherence to or misuse of therapy often results from inadequate knowledge or understanding of the disease and its treatment, psychosocial and economic factors, of side complexity of the treatment, occurrence commu¬ insufficient and effects, patient/care giver nications.1013 A poor understanding of asthma and the role of medication may lead not only to insufficient intake of drugs, such as bronchial anti-inflamma¬ tory agents, but also to overuse of others, such as P2-adrenoceptor agonists.141516 Asthma is an airway inflammatory disorder, and inhaled corticosteroids are considered to be the mainstay of its treatment, while P2-adrenoceptor agonists primarily play a role in the control of intermittent symptoms.461718 Doses of inhaled corticosteroids 1,000 fxg daily of beclomethasone in adults and 400 to 800 fig in children are considered safe, and even higher doses are preferable to poor control of asthma.18 Never¬ have different views on some of the < theless, patients p2-adrenoand and corticosteroid use, persisting ceptor agonist CHEST/113 73/MARCH, 1998 Downloaded From: http://publications.chestnet.org/pdfaccess.ashx?url=/data/journals/chest/21761/ on 04/28/2017 587 15 Spitzer WO, Suissa S, Ernst P, et al. The use of P-agonists and the risk of death and near death from asthma. N Engl J Med 1992; 326:501-06 16 Ernst P, Spitzer W, Suissa S, et al. Risk of fatal and near-fatal asthma in relation to inhaled corticosteroid use. JAMA 1992; 268:3462-64 17 Kay AB. Asthma and inflammation. J Allergy Clin Immunol 1991; 87:893-910 18 Barnes PJ, Pedersen S. Efficacy and safety of inhaled cortico¬ steroids in asthma. Am Rev Respir Dis 1993; 148(suppl):Sl-S26 19 Osman LM, Russell IT, Friend JAR, et al. 20 21 22 23 Predicting patient attitudes to asthma medication. Thorax 1993; 48:827-30 Adelroth E, Thompson S. Advantages of high-dose inhaled budesonide [letter]. Lancet 1988; 1:476 Becker MH, Maiman LA. Strategies for enhancing patient compliance. J Community Health 1980; 6:113-15 Boulet LP, Chapman KR, Green LW, et al. Asthma educa¬ tion. Chest 1994; 106:184S-96S Brewis RAL. Patient education, self-management plans and peak flow measurements. Respir Med 1991; 85:457-62 592 Downloaded From: http://publications.chestnet.org/pdfaccess.ashx?url=/data/journals/chest/21761/ on 04/28/2017 Clinical Investigations