Compliance, Adherence, and. Implications for Asthma Treatment

Transcription

1 Supplement DECREASING THE GLOBAL BURDEN OF ASTHMA Compliance, Adherence, and Concordance* Implications for Asthma Treatment Rob Horne, PhD, MRPharmS Good-quality outcomes in asthma hinge not just on the availability of medications but also on their appropriate use by patients: optimal self-management. In asthma, low rates of adherence to prophylactic (preventer) medication are associated with higher rates of hospitalization and death. Many patients choose not to take their medication because they perceive it to be unnecessary or because they are concerned about potential adverse effects. Approximately one third of asthma patients have strong concerns about adverse effects from inhaled corticosteroids (ICS). These concerns are not just related to the experience of local symptoms attributed to ICS side effects, but also include more abstract concerns about the future, arising from the belief that regular use of ICS will result in adverse long-term effects or dependence. We need more effective ways of eliciting and addressing patients concerns about ICS. The development of ICS options with an improved safety profile remains a key objective. However, the ideal solution is not just pharmacologic. We also need more effective ways of communicating the relative benefits and risks to patients in order to facilitate informed adherence. Clinicians must be prepared to work in an ongoing partnership with patients to ensure that they are offered a clear rationale as to why ICS are necessary and to address their concerns about potential adverse effects. This approach, based on a detailed examination of patients perspectives on asthma and its treatment, and an open, nonjudgmental manner on the part of the clinician, is consistent with the idea of concordance. (CHEST 2006; 130:65S 72S) Key words: adherence; asthma; compliance; concordance; patient-focused care; self management Abbreviation: ICS inhaled corticosteroids Most health-care resources in developed countries are directed toward the management of chronic illness, such as cardiovascular disease, cancer, diabetes, asthma, and mental health. Asthma management has improved markedly over the last 50 years, largely due to the introduction of inhaled *From the Behavioural Medicine Research Unit, University of Brighton, Brighton, UK. Dr. Horne has no potential conflict of interest to disclose. Manuscript received July 2, 2005; revision accepted March 20, 2006 Reproduction of this article is prohibited without written permission from the American College of Chest Physicians ( org/misc/reprints.shtml). corticosteroids (ICS) in the early 1980s, agents that are now considered to be the cornerstone of therapy for persistent asthma of all degrees of severity in adults and children. 1 Nevertheless, good-quality outcomes in asthma (and in other chronic conditions) hinge not just on the availability of medications Correspondence to: Rob Horne, PhD, Professor of Psychology in Healthcare, Director, Behavioural Medicine Research Unit, School of Pharmacy and Biomolecular Sciences, University of Brighton, Room 409, Watts Building, Lewes Rd, Brighton, BN2 4GJ, UK; r.horne@bton.ac.uk DOI: /chest.130.1_suppl.65S CHEST / 130 / 1/ JULY, 2006 SUPPLEMENT 65S

2 but also on their appropriate use by patients: optimal self-management. Both the efficacy of a medication and patient adherence to the therapeutic regimen influence the effectiveness of a treatment. 2 This article will review the underlying reasons for patient nonadherence and describe the role played by clinicians in promoting optimal medicine management. Compliance, Adherence, and Concordance The term compliance has mostly been superseded by the term adherence, a similar concept but one that has fewer negative connotations regarding the physician/patient relationship (Table 1). 3 Useofthe term compliance has been strongly criticized, as it was thought to convey a negative image of the relationship between patient and prescriber, in which the role of the prescriber was to issue the instructions and the patient s role was to follow the doctor s orders. Noncompliance, therefore, could be interpreted as patient incompetence in being unable to follow instructions, or as deliberate, self-sabotaging behavior. Adherence was introduced in an attempt to recognize a patient s right to choose, and to remove the concept of blame. Concordance 4 is a relatively recent term that is predominantly used in the United Kingdom (Table 1). Its definition has changed over time from one that focused on the consultation process in which doctor and patient agree on therapeutic decisions that incorporate their respective views, to a wider concept that stretches from prescribing communication to patient support in medicine taking. It recognizes the need for patients and doctors to work together to reach agreement, and acknowledges that patients and doctors may (potentially) have opposing views. How we deal with this presents a major challenge for medicine, particularly in the management of chronic illnesses, such as asthma. Concordance is sometimes used, incorrectly, as a synonym for adherence. The Extent of Nonadherence A World Health Organization report 5,6 suggests that 50% of patients from developed countries with chronic disease do not use their medications as recommended (see further discussion below). In developing countries, when taken together with poor access to health care, lack of appropriate diagnosis, and limited access to medicines, poor adherence seriously threatens any effort to tackle chronic illness. 5 In asthma, adherence rates are particularly problematic, generally ranging from 30 to 70%, 7 with 50% of children adhering to their prescribed inhaled medication regimens. 8 This is greatly concerning, given the vulnerability of these patients to progressive, irreversible airways obstruction. From a purely financial perspective, approximately 230 million of medicines are returned to pharmacies in the United Kingdom each year, with a great deal more disposed of by patients themselves. 6 In the United States, nonadherence to medical regimens has been estimated to cost the US healthcare system $100 billion per year. Overall, therefore, the outcome of nonadherence is loss: loss of opportunities for patients to improve their health, and loss of medication by health-care systems, with the subsequent effect of increased morbidity. 6 Understanding Nonadherence Dispelling Common Myths Unless health-care providers identify the underlying causes of patient nonadherence, it will be difficult to determine an appropriate interventional strategy. Nonadherence is not significantly related to the type or severity of disease, with rates of between 25% and 30% noted across 17 disease conditions. 9 Furthermore, providing clear information although essential is not enough to guarantee adherence. 10 Likewise, a plethora of studies have failed to identify clear and consistent relationships between adherence and sociodemographic variables, such as gender and age in adults. Adherence is positively correlated with income when the patient is paying for treatment 11 but not with general socioeconomic status. 9 Another commonly held myth is that of the nonadherent patient ; actually, there is no such thing! There is little evidence that adherence behaviors can Table 1 Terminology: Concordance and Compliance/Adherence Are Often Confused Compliance The extent to which a patient s behavior matches the prescriber s advice Adherence The extent to which the patient s behavior matches agreed recommendations from the prescriber. It has been adopted by many as an alternative to compliance, in an attempt to emphasize that the patient is free to decide whether to adhere to the doctor s recommendations and that failure to do so should not be a reason to blame the patient. Adherence develops the definition of compliance by emphasizing the need for agreement Concordance A complex idea relating to the patient/prescriber relationship and the degree to which the prescription represents a shared decision, in which the beliefs and preferences of the patient have been taken into consideration. 66S Decreasing the Global Burden of Asthma

3 be explained in terms of trait characteristics. Even if stable associations existed between sociodemographic or trait characteristics (such as personality), they would serve to identify certain at-risk groups so that interventions could be targeted, but could do little to inform the type or content of these interventions. This is not to say that sociodemographic or dispositional characteristics are irrelevant. Rather, the associations with adherence appear to be indirect and are best explained by the influence of these characteristics on other relevant parameters. For example, correlations between adherence and educational status or race may simply be a reflection of income and ability to afford prescription costs. In summary then, the notion of a typical nonadherent patient is something of a myth: most of us are nonadherent some of the time. This has led to a greater emphasis on understanding the interaction of the individual with the disease and treatment, rather than identifying the characteristics of the nonadherent patient. Nonadherence and Behavior Nonadherence can be thought of as two related types of behavior. Unintentional: Unintentional nonadherence is when the patient is prevented from implementing their intention to take the medication, as prescribed, by factors beyond their control, such as forgetfulness, poor comprehension (eg, of the drug regimen), language barriers, or physical inability to manage the medication (eg, poor inhaler technique). Unintentional nonadherence may also be related to poor recall of the consultation; studies 12 examining doctor/patient communications indicate that 5 to 10% of patients cannot accurately recall what a caregiver has advised after a consultation. Intentional: Intentional nonadherence occurs when the patient decides not to take the medication or to take it in a way that differs from the recommendations. 6,12 This often takes the form of patients reducing the dosing frequency or number of medications down to a level that they (and not their doctor) believe is appropriate, or premature treatment discontinuation. The categorization of nonadherence as unintentional or intentional is not watertight, and there is a degree of overlap. For example, more convenient treatments may be perceived in a more positive light, and one is less likely to forget to take treatments that appear more important. Moreover, nonadherence related to depression may have both intentional (the patient gives up) and unintentional components (effects on memory and other abilities). However, the division is conceptually useful, as it identifies different targets for intervention. Unintentional nonadherence may be understood in terms of skills and abilities, whereas to understand intentional nonadherence we must consider patients motivation to initiate and persist with the treatment regimen. The growing recognition of the prevalence of intentional nonadherence has increased interest in the factors influencing patients motivation to take medication. Research in this field has identified the primary importance of patients beliefs about their illness and treatment as determinant of adherence, with implications for clinical care and prescribing-related consultations. Patient Beliefs About Asthma Treatment: the Necessity/Concerns Framework Research across a range of chronic illnesses has identified similarities in the types of beliefs that influence adherence to medication. Studies of patients with renal disease, 13 asthma, diabetes, cancer, coronary heart disease, 14 hypertension, 15 HIV/ AIDS, 16 hemophilia, 17 and depression 18 have consistently found that low rates of adherence are related to doubts about personal need for medication and concerns about potential adverse effects. A study 19 in asthma has also shown that the necessity/concerns framework helps us understand patients evaluations of ICS and to explain nonadherence. Specifically, the survey 19 highlighted above reported on adherence rates to ICS in asthma patients within a primary care environment. There was considerable variation in patients beliefs about the need for ICS (Fig 1), 19 and approximately one third had marked concerns about the adverse effects of ICS, not necessarily related to actual experience, but rather to beliefs about the link between regular use and dependency or other perceived side effects (Fig 2). 19 Patients with the greatest doubts about the need for ICS, coupled with the most concerns, had significantly higher rates of nonadherence, while the converse was also true (Fig 3). 19 These findings suggest that the necessity/concerns framework identifies key perceptual barriers that could be addressed by interventions to facilitate uptake and persistence with ICS: prescribers need to counter doubts about personal need and address treatment concerns. However, to do this requires insight into the origins of these beliefs. Common Sense Origins of Perceived ICS Necessity and Concerns Beliefs About Asthma and Perceived Need for ICS Most people do not blindly follow treatment recommendations, even when they are made by trusted CHEST / 130 / 1/ JULY, 2006 SUPPLEMENT 67S

4 Figure 1. Variations in the perceived need for ICS among 218 primary care patients with asthma. Mean ICS necessity score was 3.56 (SD 0.65). Reproduced with permission from Horne and Weinman. 19 Figure 3. The influence of beliefs about the need for ICS and concerns about their potential side effects on the degree of adherence for patients reporting low (25%) adherence (n 49) vs those reporting high (75%) adherence (n 165). The low adherence group had significantly lower scores on the ICS necessity scale (solid line) and significantly higher scores on the ICS concerns scale (dotted line). Reproduced with permission from Horne and Weinman. 19 clinicians. Instead, they tend to evaluate whether the advice makes common sense in the light of their personal understanding and beliefs about the illness (Table 2). Over the last decade or so, research has advanced our understanding of the psychological process underpinning illness-related behavior. 20 This shows that, when we are faced with a health threat (eg, experiencing symptoms or when a disease is diagnosed), a fundamental response is to form a mental map or representation of the illness. This helps us to make sense of the illness and guides our Figure 2. Profile of concerns about the use of ICS among 100 primary care patients with asthma (Horne and Weinman 19 ). 68S Decreasing the Global Burden of Asthma

5 Table 2 Characteristics of Patients Common Sense Ideas About Their Illness and Treatment Influence the degree of adherence Have an internal logic Are influenced by symptoms May differ from the medical view May be based on mistaken beliefs/premises May not be disclosed in consultation Are not set in stone and may be changed actions in dealing with it. Illness representations comprise beliefs about the symptoms, causes, personal consequences, time scale (eg, acute vs chronic vs sporadic), and potential for control or cure. Although these often conflict with medical reality, they have an internal logic and coherence, and influence illness-related behavior. 21 The importance of illness representation in adherence to ICS is illustrated by a UK study 19 of the impact of illness representations and treatment beliefs on asthma self-management. This showed that patients were significantly more likely to endorse the personal need for regular ICS if they shared the medical view of asthma as an acute on chronic condition (ie, it is a chronic disease that manifests as acute symptomatic flare-up or asthma attacks) with potentially serious consequences. These patients understood that asthma remains a problem even when there are no overt symptoms of breathlessness. The rationale for the regular use of inhaled steroid (to prevent or at least lower the frequency of attacks) was easy to accept. In contrast, other patients models of asthma were more closely linked to symptom experience. These patients did not perceive their asthma as a chronic condition with potentially serious consequences. Rather, they considered themselves to be well when asthma symptoms were absent and took ICS sporadically in response to symptoms. They doubted their personal need for preventer medication because the notion of asthma as a chronic condition, needing continuous treatment, was at odds with their experience of it as an episodic problem. 22 Suspicion of Pharmaceuticals and Concerns About ICS Even before illness strikes, individuals have general beliefs that orient them either toward or away from prescribed medication. Essentially, people organize their ideas under two main themes: firstly, the nature of the medicines themselves; secondly, the extent to which these are prescribed. A significant proportion of individuals have strong negative beliefs about prescribed medicines: that they are harmful, chemical (ie, unnatural), and better avoided. 23 These social representations or background beliefs about pharmaceuticals as a class of treatment may be related to cultural background. 24 Many individuals also believe that doctors are far too willing to prescribe medications. To a certain extent, all of these ideas are fueled by the media and have led patients to turn toward the so-called natural remedies that are perceived to be a safer option. In some ways, intentional nonadherence is a wholly understandable, rational response to personal beliefs about illness and medicines. 23 Patients Perceptions of ICS Side Effects In addition to concerns about the potential dangers of corticosteroids, patients are also naturally concerned about the experience of unpleasant symptoms that they attribute to ICS. A study by Foster et al 25 found that responses to a questionnaire about local side effects provided an interesting insight into patients perceptions. A total of 395 patients, categorized by their daily ICS intake (some were only receiving inhaled 2 -agonist therapy), were asked to judge to what level they had experienced 57 side effects since they had started using their inhalers. The side effects fell into seven main groups: voice, oropharynx, cough, taste, mouth, skin, mood, and other (eg, hair loss, sweating). The perceived side effects were scored on a seven-point Likert scale (0 not at all, 6 a very great deal). Results indicated that 45% of ICS users vs 29% of 2 -agonist users reported being affected by 10 side effects to a moderate level or greater. Patients had significantly different perceptions of side effects depending on the ICS dose they were receiving (Fig 4), with multiple regression analysis showing that dose had a dominant influence on ICS side effect perception. The next most influential variables were smoking plus ICS (giving rise to a perceived increase in cough, mouth, skin, and other side effects, over and above those caused by smoking) and mouth rinsing plus ICS (which reduced the perceived level of mood and skin side effects). These findings suggest that some patients perceive local side effects. Conclusions To treat asthma effectively requires a combination of pharmacology and psychology. Effective prescribing needs to take account of patients beliefs, expectations, and adherence behavior. The research outlined in this article suggests a three-phase approach to facilitating optimum adherence to ICS. CHEST / 130 / 1/ JULY, 2006 SUPPLEMENT 69S

6 Participant Feedback and Discussion Workshop participants were asked to address the following questions related to this presentation: What are your patients barriers to adherence? Do you assess your patients adherence? If so, how? What specifically can we do to enhance adherence? Figure 4. Patient ICS questionnaire (ICQ): total cumulative ICS questionnaire score by ICS dose. Reproduced with permission from Foster et al. 25 Provide a Rationale for Persistence With ICS Patients should be given a clear rationale for why they need to take a daily ICS preventer that is not at odds with their common sense understanding of asthma. The notion that persistence is necessary, even in the absence of asthma symptoms, is particularly important. Elicit and Address ICS Concerns It is also important to elicit and address patients concerns about potential (or perceived) adverse effects. This could be part of a process of ongoing review. Some concerns may be addressed by information and reassurance, while others may require a treatment change. This process could be assisted by pharmacologic ICS solutions that have the following: (1) an improved profile, which can be communicated to patients as a potentially safer alternative to conventional ICS; (2) an alternative available, so that physicians can offer a choice to patients with strong concerns about the potential long-term adverse effects of ICS; (3) an alternative to patients who are having side effects. Address the Practical Barriers to Adherence Patients should be supported in the correct and persistent use of their ICS by addressing the practical barriers to adherence. This might include training in inhaler technique, and steps to make the regimen as convenient as possible by tailoring to the patient s lifestyle. Patient Beliefs The necessity/concerns framework was perceived to be useful in understanding why many patients decide not to use ICS as prescribed (Fig 5). The panel agreed that because ICS do not immediately relieve symptoms, patients believed that they were ineffective and, therefore, unnecessary. The panel also highlighted the importance of addressing patients concerns, not only regarding the actual experience of local side effects but also those arising from more abstract beliefs about long-term effects and dependence. Assessing Adherence to Asthma Medication A range of methods can be used to monitor adherence, each having advantages and disadvantages. The simplest method, agreed by the discussion panel, is patient self-reporting, which is cheap and easy for the patient to perform but often inaccurate. Whether or not a patient tells the truth may depend on the clinician/patient relationship and the way the question is asked; patients sometimes overestimate their adherence because they do not want to disappoint a doctor that they like/trust, or they may overestimate adherence through forgetfulness or because they have a memory bias toward days when they were compliant. As a result, doctors may unnecessarily prescribe alternative medication, request additional laboratory tests, or arrange specialist consultations to evaluate the cause of unexplained or persistent symptoms. 26 The reliability of self-reporting can be improved by reducing the pressure on patients to underreport adherence by phrasing adherence questions in a nonthreatening manner, for example, in an anonymous questionnaire. Questions could include asking the patient about the occurrence of symptoms and adverse events, as these are likely to reduce adherence to medication. A perceived lack of symptoms has been found to correlate with the underuse of ICS; many patients interrupt ICS therapy when they are asymptomatic. 27 Self-report questionnaires have been validated by comparing adherence with tablet count and clinical outcome measures. 28,29 So, while self-reporting does not provide a precise measure of 70S Decreasing the Global Burden of Asthma

7 Figure 5. Patient adherence to medication is influenced by a number of factors relating to how the individual judges the necessity of their treatment relative to their concerns. adherence, it does allow the clinician to grade patients according to their relative standing on an adherence dimension. 12 Doctors should also openly discuss the phenomenon of nonadherence with patients and highlight the medical consequences. In terms of more technological methods, the weighing of inhalers is an objective form of adherence assessment, as some patients may comply with the dispensing of medication by the pharmacy but may never actually use it as recommended. Unfortunately, the weighing of canisters may not be of great value in intentionally nonadherent patients, who may simply empty their canisters before a consultation. The use of electronic monitoring devices may generate more accurate records but may introduce bias if the appearance and functionality of the inhaler are changed. 12 Drug level monitoring is probably the only accurate method but is clearly expensive and invasive, and local application of a drug may not permit systemic detection. Improving Adherence Levels Support from professional organizations was believed to be important, as was partnering between the professional bodies in the development of multidisciplinary models of patient-focused care. Specialist asthma nurses could discuss the illness, its treatment, and any concerns at length with the patient. Furthermore, the panel believed that patients were more likely to be truthful and open with specialist asthma nurses than with clinicians. The availability of new ICS with improved profiles may also be helpful in this respect, as their availability can be communicated to patients as a potentially safer alternative to conventional ICS. We also need to take account of unintentional nonadherence by addressing the practical barriers, such as inhaler technique, and by making the regimen as convenient as possible and tailored to the patient s lifestyle. ACKNOWLEDGMENT: The author thanks Carole Manners, PhD, for writing and editorial support in the development of this article. References 1 Global Initiative for Asthma. GINA workshop report, global strategy for asthma management and prevention. Available at: Accessed June 20, Epstein LH, Cluss PA. A behavioral medicine perspective on adherence to long-term medical regimens. J Consult Clin Psychol 1982; 50: CHEST / 130 / 1/ JULY, 2006 SUPPLEMENT 71S

8 3 Haynes RB, Sackett DL, Taylor DW. Compliance in healthcare. Baltimore, MD: John Hopkins University Press, Royal Pharmaceutical Society of Great Britain. From compliance to concordance; achieving shared goals in medicine taking. London, UK: Royal Pharmaceutical Society of Great Britain and Merck Sharp & Dohme, World Health Organization. Adherence to long-term therapies: evidence for action. Geneva, Switzerland: World Health Organization, Horne R. Concordance and medicines management in the respiratory arena. London, UK: Hayward Medical Publications, Bender B, Milgrom H, Rand C. Nonadherence in asthmatic patients: is there a solution to the problem? Ann Allergy Asthma Immunol 1997; 79: Milgrom H, Bender B, Ackerson L, et al. Noncompliance and treatment failure in children with asthma. J Allergy Clin Immunol 1996; 98: DiMatteo MR. Variations in patients adherence to medical recommendations: a quantitative review of 50 years of research. Med Care 2004; 42: Weinman J. Providing written information for patients: psychological considerations. JR Soc Med 1990; 83: Piette JD, Wagner TH, Potter MB, et al. Health insurance status, cost-related medication underuse, and outcomes among diabetes patients in three systems of care. Med Care 2004; 42: Cochrane GM, Horne R, Chanez P. Compliance in asthma. Respir Med 1999; 93: Horne R, Sumner S, Jubraj B, et al. Haemodialysis patients beliefs about treatment: implications for adherence to medication and fluid-diet restrictions. Int J Pharmacy Pract 2001; 9: Horne R, Weinman J. Patients beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res 1999; 47: Ross S, Walker A, MacLeod MJ. Patient compliance in hypertension: role of illness perceptions and treatment beliefs. J Hum Hypertens 2004; 18: Horne R, Buick D, Fisher M, et al. Doubts about necessity and concerns about adverse effects: identifying the types of beliefs that are associated with non-adherence to HAART. Int J STD AIDS 2004; 15: Llewellyn CD, Miners AH, Lee CA, et al. The illness perceptions and treatment beliefs of individuals with severe haemophilia and their role in adherence to home treatment. Health Psychol 2003; 18: Aikens JE, Nease DE Jr, Nau DP, et al. Adherence to maintenance-phase antidepressant medication as a function of patient beliefs about medication. Ann Fam Med 2005; 3: Horne R, Weinman J. Self-regulation and self-management in asthma: exploring the role of illness perceptions and treatment beliefs in explaining non-adherence to preventer medication. Psychol Health 2002; 17: Cameron LD, Leventhal H. The self-regulation of health and illness behaviour. New York, NY: Routledge, Petrie KJ, Weinman J, Sharpe N, et al. Predicting return to work and functioning following myocardial infarction: the role of the patient s view of their illness. BMJ 1996; 312: Main J, Weinman J, Horne R. Explaining adherence to preventer medication in asthma. Int J Behav Med 2004; 11(suppl):72 23 Horne R, Weinman J, Hankins M. The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication Psychol Health 1999; 14: Horne R, Frost S, Weinman J, et al. Medicine in a multicultural society: the effect of cultural background on beliefs about medications. Soc Sci Med 2004; 59: Foster JM, Aucott L, van der Werf R, et al. Many patients perceive numerous side effects of inhaled corticosteroids. Primary Care Respir J 2003; 12: Weinstein A, Bender B, Apter A, et al. Achieving adherence to asthma therapy. American Academy of Allergy, Asthma & Immunology Quality of Care for Asthma Committee Paper. Available at adherence.stm. Accessed June 28, Diette GB, Wu AW, Skinner EA, et al. Treatment patterns among adult patients with asthma: factors associated with overuse of inhaled -agonists and underuse of inhaled corticosteroids. Arch Intern Med 1999; 159: Haynes RB, Taylor DW, Sackett DL, et al. Can simple clinical measurements detect patient noncompliance? Hypertension 1980; 2: Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care 1986; 24: S Decreasing the Global Burden of Asthma