Psychological issues related to compliance in chronically ill patients

by A. S. Avedisova
and M. P. Marachev, Russia

Department of Mental and
Behavioral Disorders Therapy
“V.P. Serbsky” Federal Medical
Research Centre for Psychiatry
and Narcology, Ministry of Health
of the Russian Federation
Moscow, RUSSIA


This article is devoted to the psychological aspects associated with noncompliance in chronic diseases. To study compliance, it is essential to focus on refusal of treatment—an open and conscious expression of the patient’s disagreement with the recommended treatment. Noncompliance has both emotional-cognitive and behavioral components. The degree of adherence/ resistance of patients to their treatment can be represented as a continuum of behavioral patterns—from treatment refusal to treatment addiction. Given the high incidence and the wide variety of refusals it is necessary to consider patients as individuals with their own personal beliefs about their illness. These beliefs often differ from the biologically oriented views held by medical professionals. The discrepancy between the patients’ conceptualizations and the doctors’ specialized medical knowledge is actualized in the doctor/patient relationship and leads to refusal of treatment. Evaluating the patient from both a medical and psychological perspective prompts doctors to have a dual role: on the one hand, doctors have medical knowledge, but on the other hand, they need to consider the patients’ ideas, expectations, fears, and misconception while trying to persuade them of the necessity of following a long-term treatment and making lifestyle changes. This psychological element of the doctor/patient relationship should be taken into account in the fight against noncompliance.

Compliance has become a stumbling block in modern medicine, because adherence to the doctor’s directions regarding medications and important lifestyle aspects is often a decisive factor in the success or failure of any treatment, regardless of the effectiveness of the drugs prescribed. The problem of compliance is multifactorial and reflects the biopsychosocial complexity of the majority of somatic and mental diseases.

Incidence of noncompliance

The urgency of this problem should not be underestimated as extremely high levels of noncompliance have been found in various areas of clinical medicine.1 For example, one study found that 55.3% of patients stopped antihypertensive and antilipidemic therapy after 3 months of treatment, and that 64.2% of patients stopped their treatment after 12 months.2 In another study it was found that 37% of patients with diabetes completely stopped taking their drugs 12 months after the initial prescription of therapy.3 Moreover, only 7% of patients with insulin-dependent diabetes were found to follow all the recommendations necessary to control their disease.4 In patients with acute myocardial infarction, a study found that preventive therapy was discontinued by 7% of patients after 1 month, 32% after 1 year, and 50% after 2 years.5 In patients with asthma, the ADERE study showed that the level of noncompliance to anti-asthmatic therapy reached 49.1% after 90 days.6 In patients with venous leg ulcers preventive therapy was stopped after 1 year in 50%- 60% of cases.7 Finally, the level of noncompliance in patients with chronic mental diseases, in particular schizophrenia, was found to be 59.1% after 4 months of treatment,8 and in patients with depression, it was of 60% on average.9

These data on the incidence of noncompliance are striking, especially given the fact that, first and foremost, patients want their illness not to recur. This high level of noncompliance cannot be interpreted by economic aspects, since drug therapy expenses are reimbursed by health insurance in the vast majority of developed countries. At the same time, since the incidence of noncompliance is similar for many medical conditions (ie, ranging between 50% and 60% after 1-2 years), neither the nature of the disease nor its severity can fully explain such high levels of noncompliance. Furthermore, noncompliance levels for different classes of drugs have also been found to be alike: the level of noncompliance in 36 984 patients taking psychotropic drugs was found to be similar for all types of drugs (34.6% for antipsychotics, 34.7% for sedatives/ hypnotics, 38.1% for anxiolytics, 44.9% for mood stabilizers, and 45.9% for antidepressants).10 The only conclusion that can be drawn from these studies is that the level of noncompliance tends to grow dramatically as the duration of the treatment increases, regardless of the illness, its severity, and the treatment prescribed.11,12

However, great difficulties arise with regard to the definition of the term “noncompliance.” According to the DSM-IV (1994), the category of “noncompliance with treatment” can only be used when “the focus of clinical attention is noncompliance with an important aspect of the treatment for a mental disorder or a general medical condition.”13 Consequently, it is only the important aspects of therapy that are taken into account. Moreover, the notion of “importance” is determined by doctors, not patients, which leads to frequent discrepancies in the points of view of doctors and patients and may actually result in noncompliance. The term “adherence” used to refer to this problem is fundamentally different and indicates the degree to which the patient’s behavior is consistent with medical requirements, that is, with any deviation from the prescribed medical recommendations. This term implies that the patient has the right to choose between compliance and noncompliance with recommendations, and emphasizes the patient’s right to choose. Finally, the more neutral term of “concordance” is more commonly used in the UK, and indicates that there is a partnership in the process of making a therapeutic decision.

The various conceptual models of compliance, which reflect the variety of research approaches used to study this problem, are equally contradictory. They include (i) a biomedical model14; (ii) a behavioral model15; (iii) an educational model16; (iv) a model based on popular beliefs about health17; and (v) a self-regulation model.14 The differences between these various models, which make it difficult to compare the studies that investigate compliance, and the lack of a unified theory regarding its development have led to criticism of the models themselves and of the results obtained with their use.18 Aside from the differences in the definition of “compliance” and the different models that have been proposed, there is also a lack of full-fledged standardized methods for its evaluation. As a result, the evaluation methods used in various studies are often incomparable (qualitative and quantitative; subjective and objective; direct and indirect; with variations in the duration of the observation period and disparity in the criteria used to define noncompliance [any deviation from the recommended drug regimen or only unacceptable ones), and this partly explains the wide discrepancies in the compliance levels of patients with chronic diseases reported in some studies. For example, the compliance level of diabetic patients in 11 retrospective studies ranged from 36% to 93%.19

Factors contibuting to noncompliance

The majority of studies have focused on the causes of patients’ disagreement with their treatment and the many factors that increase or decrease it. For example, there are about 250 factors that affect patient compliance to psychopharmacological treatment.20 These factors pertain to patients, doctors, the doctor-patient relationship, treatment-specific aspects, and disease-specific features. It should be emphasized that these kaleidoscopic determinants of noncompliance are extremely variable and fluctuate according to the situation: for example, loss of confidence in a doctor or iatrogeny can turn compliance into noncompliance in just one day, which demonstrates the subjectivity of certain factors. The factors that contribute to noncompliance are closely associated with treatment duration, which, as it increases, reduces the role of factors pertaining to the patient’s condition and therapy, increases the role of factors pertaining to the patient and the doctor/patient relationship, and as a result amplifies the importance of the social, legal, ethical, and even philosophical and cultural aspects of therapy.

Only a few of the factors contributing to noncompliance are solely negative while most factors contribute to both compliance and noncompliance (eg, patient awareness about possible side effects, prescribed medications, once-daily administration). In our view, full compliance is just the midpoint in a broad continuum of adherence/resistance to ongoing therapy— from total or partial withdrawal from therapy to an addiction to it—and is the goal to achieve (Figure 1). At the same time, noncompliance—ie, anything less than full compliance— has many different forms and needs careful analysis and study.

Figure 1. Continuum of patient adherence/resistance to pharmacotherapy.

The terms “compliance” and “noncompliance,” despite their importance in clinical practice, are concepts that are too broad and difficult to investigate. So, in many ways, agreement/disagreement with a treatment often appears as a subjective category that cannot be objectively analyzed with ease. At the same time, it should be noted that compliance is often achieved in patients with certain disorders (eg, hypochondria) or in certain settings (eg, rental), which raises the question of its desirability.

Refusal of treatment

To facilitate immediate evaluation, and therefore, to facilitate scientific research, it is first necessary to characterize the most important and measurable components of noncompliance. In this sense, refusal of treatment can be regarded as the most obvious or extreme form of noncompliance, since it is an open and conscious expression of the patient’s disagreement with the recommended treatment, accompanied by a corresponding behavioral response.21 Proceeding from this definition, the structure of any refusal of treatment includes two components: (i) an emotionally-cognitive component: the patient’s decision to refuse to take the treatment is an inference accompanied by an emotional reaction; and (ii) a behavioral component: a violation of the treatment regimen, most often congruent to the decision (behavior pattern). If the emotional- cognitive component does not correspond to the behavioral component, the patient may display an “ambivalent” behavior—ie, formal adherence to the doctor’s instructions despite internal rejection—or a “selective” behavior—ie, carrying out of the medical recommendations depending on their correspondence with the patient’s own ideas. In some cases, when the cognitive component of the refusal of the recommended or ongoing treatment is underdeveloped in the patient’s mind, we talk about “latent failures,” which are often masked by simple “forgetfulness.” At the same time, the component of “experiencing” or comprehending one’s disagreement with the proposed therapy is reduced, and the behavioral component is realized outside the framework of conscious assessment and control of behavior, as if automatically.

Thus, refusal of treatment is a kind of “turning point” in the construction of the “psychiatrist-patient” relationship, and acts as the central model for the study of noncompliance. It is the result of all the factors causing its emergence, thanks to which it can be not only primarily diagnosed, but also comprehensively evaluated and measured. So, the evaluation of noncompliance is, in fact, an assessment of treatment refusal. Among the different types of refusals, we can distinguish: full or partial refusals (Axis I); primary/early or secondary/late refusals (Axis II); single or recurrent refusals (Axis III); competent (conscious) or incompetent (hidden) refusals (Axis IV) (Figure 2).

Figure 2. Refusal of treatment in patients
with depression.
Axis I: full or partial refusals. Axis II: primary/early or secondary/
late refusals. Axis III: single or recurrent refusals.

The incidence of the different types of treatment refusal depends on the stage of care at which they occur. Outpatients with chronic diseases most often show fewer primary and total refusals—ie, when patients refuse the whole “package” of care even before the beginning of treatment—than secondary (usually partial) refusals. Consequently, partial (70.4%), secondary, (72.3%), and recurrent (71.1%) refusals predominate in patients with chronic depressive disorders (Figure 2). It should be noted that the number of complete (as well as primary) refusals of pharmacotherapy is likely to be much higher than registered since some people with medical problems do not seek medical help at all (which amounts to refusal of treatment). Primary refusals are potentially unfavorable for two reasons: they significantly increase the risk of deterioration caused by the refusal of preventive treatment, and at the same time they are indicators of the deterioration itself.

There are specific motivations for the different types of treatment refusal in patients with chronic diseases. Their study in patients with chronic depressive disorders receiving antidepressant therapy showed that adverse events are one of the most significant causes of secondary (complete/incomplete) treatment failure.22 However, what is important is not only the quantity and spectrum of adverse events, but also how they are tolerated: some adverse events are so subjectively painful and difficult to bear that patients refuse to take their medications, despite understanding the need for their administration. The results of a survey of outpatients with depressive disorders (according to the points of the UCU scale) regarding the degree of tolerability of adverse events (tolerable, moderately tolerable, intolerable) after administration of a drug (presumed or a priori tolerability) showed that there was a high degree of subjectivity for the vast majority of them.23 At the same time, patients generally show the least tolerance for various vegetative/ neurological adverse events, and the most for psychiatric adverse events. The main sex differences in the a priori tolerability of therapy are primarily associated with a much higher risk of refusals due to intolerance to adverse events (sometimes several times!) among men than women, for all major groups of adverse events.

Motivations that are not related to the tolerability and efficacy of the treatment are prevalent for total and primary refusals and account for about 30% of secondary and complete/partial refusals. For the latter, motivations include distrust of medicine, preference for traditional methods of treatment or psychotherapy, distrust of the doctor, fear of a reduction in their quality of life, well-being, recovery—and therefore belief that drug therapy is not needed; fear of the reoccurrence of side effects in case of a previous experience with the treatment, financial constraints, etc.

The high incidence and wide array of refusals that are not related to treatment efficacy and tolerability dictate the need to consider patients as having an active role in their treatment. Acceptance of the patient’s subjectivity allows us to assess him/her not only from a medical point of view, but also from a psychological point of view by integrating his/her knowledge and awareness of the disease, attitude toward it, understanding of the role and influence of the disease on personal-environmental interactions, knowledge of the complex reactions associated with the disease and of the features of protective adaptive and coping mechanisms. Adherence to medical recommendations is an important aspect of the psychological side of the treatment process, which is determined not only by objective reasons, but also by subjective beliefs. Based on their own subjective beliefs, patients predict the possible outcomes of their illness and make decisions about whether to refuse the treatment.

According to Groeben and Scheele,24 subjective theories are to be understood as a “cognitive aggregate of the view of the self and of the world, which allows (at the very least) a partial explication, or rather, a reconstruction parallel to structures of scientific theories.” These theories are the result of the sufferer’s search for an explanation for their illness. They are formed when patients ask themselves whether they believe themselves to be really sick (or whether, for example, their condition is the result of poor lifestyle) and when they consider their current disease state (severity), their understanding of the causes and subsequent course of their disease (eg, “I got this from my mother” and “I’ll never get well” or “it’s all due to stress” – “If I rest, it will go away”), which methods they think are adequate and useful for improving their condition (eg, “no drugs” or “no lifestyle changes at all”), and what they expect from the treatment (eg, “full recovery”). At the same time, patients rely on the cultural beliefs surrounding their disease, the social environment (medical personnel, relatives), and personal experience, etc. It is not a question of whether the patients’ subjective beliefs about their disease are “correct” or “wrong.” The point is that they often differ from the biologically oriented perspective of doctors, and it is the discrepancy between the patients’ subjective conceptualizations and the doctors’ specialized medical knowledge (regarding the etiology of the disease, its course, and prognosis) that often predetermines refusal of treatment in patients with chronic diseases. This discrepancy is usually realized in the relationship between doctor and patient. Arthur Frank, an expert in medical ethics, describes the process of a patient seeking medical help as one of agreeing to tell his/her story in medical terms.25

The results of focused interviews between two groups of respondents— patients with chronic psychiatric disorders (consumers of medical care) and their doctors—on the question of long-term therapy and the reasons for refusing it clearly showed that these two categories of respondents have a different outlook on the course and prognosis of the chronic disease, that is, different health/disease models.26

Conceptual models of health and illness

The first model, the biomedical model, is focused on the identification of genetic factors and biological processes, and is based on a dimensional approach, according to which categories such as “health” and “disease” can be located on opposite sides of a one-dimensional continuum. In this model, remission of a chronic disease should not be considered as a stabilization of the condition, but rather as a temporary decrease in the pathological process activity due to various factors (including therapeutic intervention). This position corresponds to the basic postulates of the biological sciences, which actively involve the use of arguments obtained as a result of genetic, instrumental, pharmacological, and morphological studies, and sees the clinical manifestations of a chronic disease as the final result of lifelong biological anomalies. According to this model, patients do not recover; the same approaches should thus be applied for a chronic disease patient in remission as for patients with disease decompensation. When doctors consider that refusal of treatment is one of the symptoms of the disease (anosognosia), they are in full agreement with the biological approach.

The second model is the psychodynamic model, and corresponds to the patients’ subjective conception of their disease. It is based on a categorical approach (list of symptoms) and requires a separation of the concepts of “norm” and “pathology,” “sick” and “cured.” This position, which is that of the majority of consumers of health care, actually directly reflects the natural reluctance of most people to consider themselves sick (ie, taking drugs, changing their habitual lifestyle) after achieving a stable improvement in their condition. An interesting aspect of this point of view is that the concept of recovery includes not only the disappearance of pathological symptoms, but also psychological recovery from the consequences of the disease. Thus, treatment refusal (which in this case is defined as secondary), is subjectively regarded as one of the stages of psychological recovery, in addition to the expected improvement in daily activities due to the absence of adverse events.

The expectation of doctors that their patients will choose the biomedical model of the disease and “speak the same language” as them is the central mistake of the medical profession, and leads to a one-sided view of the problems of the doctor/patient relationship. Stemming from that mistake, numerous programs aiming to increase the compliance of patients with certain chronic diseases focus only on the “medical” model of the disease (in particular, programs to improve the level of medical knowledge of patients).

However, modern theories of medical communication consider that patients have complex personalities, with very personalized and unique ideas about their health and illness.27 Motivating patients with chronic diseases to follow medical recommendations is an extremely difficult task for doctors. They need to have a dual role when talking to their patients: on the one hand, they provide biologically oriented medical knowledge about the etiology and pathogenesis of the disease and its treatment, and on the other hand, when arguing the need for long-term treatment and lifestyle changes, they should take into account the “consumers” and their language, their ideas, expectations, fears, misconceptions, and adjust to each patient patiently and persistently. It is known that imposed medical requirements, if they do not fit in with the patient’s ideas of the disease, will not take root. In this case, medical requirements may lose their subjective effectiveness, sometimes giving way to absurd recommendations, retaining their appeal, despite the objective harm, only by their correspondence to the patient’s ideas.

A more modern and effective strategy to establish an effective doctor/patient relationship is to take into account the fact that patients are the best source of information about the problems that affect their decision to agree to long-term therapy. The paradox is that treatment adherence is observed and evaluated by clinicians, while the related problems are largely psychological and require appropriate knowledge, thus making it necessary to first provide training for doctors. ■

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Keywords: behavior; chronic disease; compliance; doctor-patient relationship; noncompliance; psychological factor; refusal of treatment