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Review

Adherence to disease management programs in patients with COPD

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Pages 253-262 | Published online: 20 Oct 2022

Abstract

The management of COPD is complex and patient adherence to treatment recommendations is known to be poor. In this paper the methods used for evaluating adherence in COPD are compared. Self-reporting has satisfactory reliability and offers a cheap, simple and easy method for assessing adherent behaviors. Unlike the objective measures of adherence such as electronic monitoring, self-reporting helps in identifying the reasons for nonadherence, which in turn would be useful in addressing adherence issues.

Patients do not follow their treatment recommendations either intentionally or unintentionally. Intentional deviations are driven by patient beliefs and experiences about illness and treatment, which are in turn influenced by social and cultural factors. Unintentional deviations are often due to cognitive impairment and lack of routines. Factors associated with adherence in COPD have been explained using the Becker-Maiman model.

Strategies for overcoming nonadherence have to be formulated based on the nature and reasons for nonadherence. In the event of unintentional nonadherence, the use of adherence aids like Dosette boxes, calendar packs and reminders should be promoted. Understanding patient beliefs and experiences, patient education focusing on the pathology of COPD and the role of treatment, periodic monitoring and reinforcement are critical for overcoming the barriers of intentional nonadherence.

Introduction

Chronic obstructive pulmonary disease (COPD) is and will continue to be a major public health problem in both developed and developing countries (CitationMurray and Lopez 1996, Citation1997; CitationWHO 2004). Progressive introduction of pharmacologic, nonpharmacologic and surgical treatments are often necessary to cope with the deteriorating respiratory function in COPD (CitationPauwels et al 2001). Treatment effectiveness in any condition depends not only on the appropriateness of the drugs prescribed and/or the recommendations given, but also on patient commitment to the intended treatment (CitationMarinker et al 1997). Failure to take medicines as intended or deviations from recommended management might result in therapeutic failure as well as wastage of health resources (CitationMcKenney and Harrison 1976; CitationCol et al 1990; CitationStanton et al 1994; CitationHoward et al 2003). Health professionals may be unaware of their patients’ drug utilization patterns and may underestimate the effectiveness of drug regimens, in turn leading to prescribing errors (CitationMellins et al 1992). The importance of patient commitment for the success of COPD management programs is well recognised (CitationPauwels et al 2001).

The extent to which a person’s behavior (in terms of taking medications, following diets, or executing lifestyle changes) coincides with medical or health advice was labeled as ‘compliance’ in late 1970s (CitationHaynes et al 1979). In the modern era patient rights not to follow the medical advice is well recognized and ‘compliance’ is regarded to be politically incorrect. It is increasingly being replaced with ‘adherence’, which is less judgmental and more respectful of the role that patients can play in their own treatment (CitationMarinker et al 1997). Deviations from clinical prescriptions or recommendations have been evaluated quantitatively and qualitatively. Quantitative definitions for medication adherence often refer to the extent of those deviations and include amount of medicine taken over a given time period, or to the extent of its correlation with aspects such as the recommended timing of the medication, the intended duration of the treatment and the recommended method of administration (CitationMarinker et al 1997). Based on the extent of utilization, three patterns of medication nonadherence – viz ‘underutilization’, ‘over utilization’ and ‘inappropriate use’ have been reported (CitationDolce et al 1991). In a meta-analysis of studies reporting adherence to medical treatment, the average nonadherence rate was found to be 24.8% (CitationDiMatteo 2004).

Qualitative definitions refer to variables such as intentionality, memory and health beliefs that result in deviations from the recommended treatment (CitationMarinker et al 1997). Deviations from treatment recommendations could be intentional and/or unintentional. ‘Unintentional nonadherence’ may be due to simple forgetfulness, or inability to follow treatment instructions because of poor understanding or physical problems such as poor eyesight or dexterity problems (CitationMarinker et al 1997). ‘Intentional nonadherence’ arises when the patient rejects either the doctor’s diagnosis or the doctor’s recommended treatment (CitationHorne 1997; CitationMarinker et al 1997). The latter is often a rational decision made by the patient to reject either the diagnosis or the recommended treatment after careful consideration of the perceived risks/costs versus benefits and has been called ‘intelligent nonadherence’ (CitationWeintraub 1990). It is often driven by patient beliefs and experiences about illness and treatment, which are in turn influenced by social and cultural factors. This paper gives an overview of adherence research in COPD with a focus on the methods employed for studying adherence and the factors associated with adherent behavior.

A literature search using OVID and International Pharmaceutical Abstracts (IPA) was performed with the following terms: (COPD OR bronchitis OR emphysema) AND (adherence OR compliance OR concordance). Relevant articles were selected after reviewing the abstracts.

Adherence in COPD

Adherence to both pharmacological and non-pharmacological management is critical for optimal outcomes in patients with COPD (CitationPauwels et al 2001). Good medication adherence was associated with both decrease in the number of hospitalizations and length of hospital stay among patients with chronic respiratory ailments (CitationBalakrishnan and Christensen 2000). It would be reasonable to assume that in a symptomatic disease with progressive decline in quality of life such as COPD, patients would strictly follow the medical advice. However, in a meta analysis of adherence studies, the mean adherence to medical treatment in pulmonary diseases was found to be only 68.8% (CitationDiMatteo et al 2002), which was much less compared to mean adherence in other chronic disease conditions. Nonadherence in COPD is a multi-dimensional quandary and includes short and long-term medication nonadherence (CitationChryssidis et al 1981; CitationTaylor et al 1984; CitationJames et al 1985; CitationDolce et al 1991; CitationDompeling et al 1992; CitationRand et al 1992, Citation1995; CitationTurner et al 1995; CitationBosley et al 1996; CitationHatton et al 1996; CitationPepin et al 1996; CitationSimmons et al 1996, Citation2000; CitationCorden et al 1997; CitationGallefoss et al 1999; CitationBalakrishnan and Christensen 2000; Citationvan Grunsven et al 2000), nonadherence to life style changes such as smoking cessation (CitationJames et al 1985; CitationRand et al 1995; CitationTurner et al 1995; CitationGallefoss et al 1999; CitationYoung et al 1999; CitationMapel et al 2000; CitationSimmons et al 2000), non-participation in or early withdrawal from respiratory rehabilitation or exercise programs (CitationYoung et al 1999; CitationEmery et al 2003; CitationArnold et al 2006), failure to meet vaccination requirements (CitationFox et al 1995; CitationNichol et al 1999; CitationGarcia-Aymerich et al 2000), missing scheduled clinic or home visits (CitationTurner et al 1995; CitationHatton et al. 1996), and inadequate monitoring of treatment response (CitationGallefoss et al 1999). Underutilization (CitationTaylor et al 1984; CitationJames et al 1985; CitationDolce et al 1991; CitationDompeling et al 1992; CitationHatton et al 1996), overutilization (CitationChryssidis et al 1981; CitationJames et al 1985; CitationDolce et al 1991; CitationPepin et al 1996) and inappropriate use (CitationAllen and Prior 1986; CitationHorsley and Bailie 1988; CitationDolce et al 1991; CitationDompeling et al 1992; CitationChapman et al 1993; CitationNimmo et al 1993; CitationGray et al 1994, Citation1996; CitationThompson et al 1994; Citationvan Beerendonk et al 1998; CitationJohnson and Robart 2000; Citationvan Grunsven et al 2000) of medications have been reported among patients with COPD. Poor adherence to drug therapy and disease management programs has been identified as the major factor resulting in emergency hospitalization among COPD patients (CitationCol et al 1990; CitationFuso et al 1995; CitationGarcia-Aymerich et al 2000).

Adherence evaluation in COPD

Various direct and indirect methods have been used for evaluating treatment adherence in COPD. The majority of the adherence studies have been carried out from the health professionals’ perspective with little regard for the perspective of patients. Wide variation exists in the definitions, classifications and ‘cut-off values’ for optimal adherence in different studies. Each method has its own limitations and advantages. Wide variations were observed in the extent of nonadherence reported among COPD patients, based on the definition of adherence used, the method of assessment, the focus characteristic chosen for adherence assessment, ‘cut-off values’ for classification as adherent or nonadherent, patient population, time of assessment, and duration of follow-up. An overview of the various methods used for assessing adherence in COPD is given in Table .

Table 1 Methods for studying adherence in patients with chronic respiratory disease

Few researchers have used multiple methods or tools to study adherence in their study population and compared the results (CitationTaylor et al 1984; CitationDolce et al 1991; CitationDompeling et al 1992; CitationRand et al 1992, Citation1995; CitationNides et al 1993; CitationBosley et al 1995; CitationSimmons et al 2000). Self-reporting of missed doses underestimated nonadherence when compared to more objective measures such as capsule count (CitationDompeling et al 1992), inhaler weights (CitationRand et al 1995) and electronic monitoring (CitationRand et al 1992; CitationBraunstein et al 1996; CitationSimmons et al 2000). Self-report had moderate reliability (25%–67%) when compared against more objectives measures of adherence such as canister weight (CitationRand et al 1995) and electronic monitoring (CitationGong et al 1988; CitationNides et al 1993; CitationBosley et al 1995). Being aware of monitoring of medication adherence using objective methods such as electronic monitoring might encourage some patients to exaggerate their self-reported adherence (CitationSpector et al 1986). Awareness of monitoring device or feedback on monitoring results might improve patient adherence with the medication(s) under surveillance (CitationNides et al 1993; CitationTurner et al 1995), but at the same time patients could be nonadherent with any medications unmonitored (CitationTurner et al 1995).

Electronic monitors provide more objective and reliable information on adherence than any other measures of adherence that are currently available. However, they are useful only to detect the presence of a problem (nonadherence); they are unable to find the cause of the problem. For example, intentional nonadherence (such as steroid phobia) cannot be differentiated from unintentional nonadherence (eg, forgetfulness). Hence electronic monitors are not helpful in finding solutions for the issue, even if detected. Moreover, the feasibility and cost effectiveness of electronic monitoring in routine clinical practice are doubtful (CitationGong et al 1988). In the era of ‘concordance’ where adherence is assumed to be the joint responsibility of the patient and health professionals, the use of such devices without patient knowledge is unethical and might even disrupt the mutual relationship between the health professionals and patients. Currently electronic monitors are not available for all the available dosage forms (eg, strip-packed tablets). Electronic monitoring cannot ensure that the medication withdrawn from the container had actually been consumed. Technical problems like battery failure or data retrieval problems have been shown to result in loss of adherence data, suggesting that researchers should not depend entirely on electronic monitors for monitoring adherence (CitationGong et al 1988; CitationNides et al 1993; CitationBraunstein et al 1996; CitationSimmons et al 1996, Citation1998, Citation2000). Self-report of nonadherence has been shown to have satisfactory reliability among patients with COPD, when verified against objective measures (CitationDolce et al 1991; CitationNides et al 1993; CitationRand et al 1995). Overestimation of adherence and poor reliability are common criticisms about self-reports; however, people who report nonadherence are likely to tell the truth (CitationHaynes et al 1980; CitationInui et al 1981; CitationChoo et al 1999; CitationErickson et al 2001).

Very few studies have incorporated inhalation technique assessment into the medication adherence evaluation process (CitationDolce et al 1991; CitationDompeling et al 1992; CitationTurner et al 1995). Inhalation techniques have been assessed using checklists adapted from guidelines set by different professional organizations (CitationAllen and Prior 1986; CitationArmitage and Williams 1988; CitationHorsley and Bailie 1988; CitationDolce et al 1991; CitationDompeling et al 1992; CitationChapman et al 1993; CitationNimmo et al 1993; CitationGray et al 1994, Citation1996; CitationThompson et al 1994; Citationvan der Palen et al 1995, Citation1999; Citationvan Beerendonk et al 1998; CitationJohnson and Robart 2000). Only few researchers have assessed the total inhaler technique (CitationHorsley and Bailie 1988; CitationDompeling et al 1992; CitationConnolly 1995), while others categorized the steps in the inhalation process into ‘key’ or ‘essential’ and ‘non-essential’ steps and assessed only those ‘critical steps’.(CitationDompeling et al 1992; Citationvan der Palen et al 1995, Citation1999; Citationvan Beerendonk et al 1998) Multiple raters (up to five) were involved in the assessment process in some studies (CitationAllen and Prior 1986; CitationChapman et al 1993) and the poor inter- and intra-rater reliability reported among the raters (CitationAllen and Prior 1986; CitationChapman et al 1993; CitationGray et al 1994), even for the ‘critical steps’, is a concern (CitationGray et al 1994). Some of the newer devices incorporate a flow sensor which has the capability to track the actual dose inhaled. Even ‘objective monitoring’ could detect only one of the problems associated with inhalation technique, ie, inadequate respiratory volume following canister actuation (CitationChapman et al 1993).

Factors associated with adherence in COPD

Patients with COPD have many potential risk factors for nonadherence. COPD being a disease condition characterized by multiple comorbidities (CitationBall et al 1995; CitationMapel et al 2000; CitationConfalonieri et al 2001; CitationIncalzi et al 2001; CitationGeorge et al 2005), patients are likely to be on complex medication regimens consisting of time-contingent and prn (when required) oral and inhaled respiratory medications (CitationDolce et al 1991; CitationJackevicius and Chapman 1997; CitationPauwels et al 2001) as well as other medications (CitationChryssidis et al 1981). Over one-third of patients with COPD were found to use complementary and alternative medicines (CitationGeorge et al 2004, Citation2005), adding further complexity to their already complex medication regimens. Complexity of the prescribed drug regimen in COPD is known to increase with disease severity as well as the presence of comorbidities (CitationFriedman 1995). Patients often need to make alterations in their drug regimen depending on disease severity, opportunistic respiratory tract infections and seasonal changes. Reduction of therapy once symptom control has been achieved is not normally possible, even though none of the existing medications for COPD has shown to modify the long-term decline in lung function (CitationPauwels et al 2001; CitationCranston et al 2005).

According to CitationBecker and Maiman (1975), motivating factors, and positive modifying and enabling factors contribute to adherence, while their absence or opposite effects could put adherence at risk. Factors found to be associated with adherence in COPD in various research studies could be incorporated into the Becker-Maiman model to explain adherent behavior of COPD patients (Table ). Despite differences between these studies in methods employed to detect nonadherence, cut-off values used for classifying patients as adherent or nonadherent, and the populations studied, adherence in COPD was found to be a dynamic process controlled by the presence or absence of motivating factors, and modifying and enabling factors. The validity of this model has been confirmed in both qualitative and quantitative studies (CitationGeorge et al 2005, Citation2006a, Citation2006b).

Table 2 Factors associated with medication nonadherence: Becker-Maiman model

Patients analyze the benefits in following a recommended treatment against the risks/cost associated with it. They are likely to disregard those treatments which in their experience have little efficacy or if there are concerns about their safety or their impact on patients’ lives. Regimen complexity does not pose challenges to adherence in those who could ‘routinize’ their medication regimen, ie, those who could incorporate medication taking into their unique and complex daily lives (CitationRyan and Wagner 2003; CitationGeorge et al 2006a). The need for managing a complex medication regimen could be an issue in patients with cognitive impairment and those with depressive illness, which might explain the unintentional deviations from the treatment recommendations observed in some elderly COPD patients. The poor inhalation techniques among patients is not surprising when health professionals such as doctors, respiratory therapists, nurses and pharmacists who are involved in educating patients on inhalation techniques, themselves are known to have poor knowledge and ability (mainly on the ‘critical steps’) to use those devices (CitationGuidry et al 1992; CitationKesten et al 1993).

Message for health professionals and researchers

Many patients with COPD do not follow their treatment recommendations either intentionally or unintentionally. Motivating, enabling and modifying factors related to patient, disease, treatment, and health care providers could influence adherence. As time evolves COPD patients become more health conscious due to the progression of the disease and increase in disease burden, resulting in improved adherence. However, in the short-term adherence is likely to decline over time, unless enhanced by feedback and reinforcement. Patient knowledge about the role of treatment, confidence and feedback from health professionals are likely to enhance treatment adherence among COPD patients.

Adherence screening on all aspects of management should be routinely performed in patients with COPD using simple and practical tools. This need exists for all patients with COPD including those whose nonadherence has not been a concern in the past. Health professionals should devote more time for patients whose nonadherence is of concern. Identifying the nature of nonadherence and the reasons for nonadherence are also critical in clinical practice along with its detection and quantification. Multiple methods – including objective measures – should be employed for monitoring adherence in clinical practice, especially when nonadherence is suspected. Electronic monitoring, though regarded as the ‘gold standard’ for adherence monitoring, is more appropriate in a clinical trial setting where the investigators have to ensure that patients use their drugs as prescribed and need to identify those patients who are not. Self-reporting offers a cheap, simple and easy method for assessing adherent behaviors. In addition, reasons for nonadherence can be identified using self-report, which in turn would help in addressing those issues. Inhaler technique assessment forms a key component of adherence assessment in COPD and should be performed periodically.

Strategies for overcoming nonadherence have to be formulated based on the nature and reasons for nonadherence. In the event of unintentional nonadherence, especially in the elderly; those with complex medication regimens; and those with cognitive impairment, the use of adherence aids such as medication lists, Dosette boxes and timers should be promoted. Wherever possible, the recommend treatment regimens should fit into the lifestyles and limitations of patients and their families. Coordinating medication use with a daily activity; storage of medications at places closer to their use; and assistance/reminding systems for the timely administration of medicines and for regular supply of medicines might avoid unintentional nonadherence.

Understanding patient beliefs and experiences, patient education focusing on the pathology of COPD and the role of treatment, periodic monitoring and reinforcement are critical for overcoming the barriers of intentional nonadherence. The impact of patient education is likely to be enhanced if health professionals elicit patients’ concerns and disappointments about their management and address those issues on an individual basis. Such efforts are likely to enhance COPD patients’ confidence leading to improved patient adherence to both medications and non-pharmacological management. When the health care professionals are unsure and have questionable inhalation skills, their patients cannot be expected to use the inhalation devices properly. Training in inhalation techniques and their assessment are critical for all health professionals involved in instruction and assessment of inhalation techniques for patients. New interventions for reducing intentional and unintentional nonadherence in COPD need to be developed and tested in large randomized controlled trials.

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