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Linus Geisler: Doctor and patient - a partnership through dialogue   © Pharma Verlag Frankfurt
Compliance
What is compliance?
The problem of non-compliance
Causes of non-compliance 
Measures which can encourage compliance
 
It is not enough to prove a thing. One must
also convince others about it.
Friedrich Nietzsche
Compliance
What is compliance?
Compliance is the willingness to follow a medical recommendation. It is not possible for either the doctor or medical practice to function without compliance. Non-compliance is the death of all active medicine. Compliance is not a new phenomenon, but rather a new term for an old, central problem of cooperation between doctor and patient.

The term "compliance" arose at the beginning of the 70's, at a time when the first systematic studies were initiated to answer the question: "How many of the patients who are advised to do something by their doctor, actually do it?" Compliance should not be confused with training, instant obedience or patronizing the patients. In the widest sense, compliance means cooperation as a result of a partnership-like relationship of doctor and patient.

Compliance is the most important result of successful communication between doctor and patient. One of the central tasks of the discussion between doctor and patient is to achieve compliance. The leading American researcher in compliance, A.R. Jonsen summed it up as: "Compliance is really less the result of ethics but much more that of the art of speech."
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The problem of non-compliance
Many studies have revealed that non-compliance is one of the great practical problems in medical practice. Compliance research has shown that non-compliance is far more extensive than previously thought:
35-40% of all prescribed medication are not taken (the estimated cost for West Germany was estimated to be about 5-7 milliard DM per year).
Even medication which is considered vitally important is taken regularly only at rates under 50%.
Non-compliance rates of 50-80% are found amongst hypertensives.
Diabetic women eat 100-200 kcal per day more than non-affected women of the same age.
Non-compliance for pre-natal exercises is about 50 %.

Why is it that non-compliance is so widespread? On superficial consideration, one could come to the conclusion that non-compliance is not abnormal, but far more likely to be taken for granted. Is however non-compliance really only the result of mankind's weak nature that everyone falls back into old habits, and it has something to do with the fact that forgetfulness is a natural phenomenon of existence?

On closer examination it is clear that these explanations do not hold water. A person is suffering; he finds a doctor, and visits him with the objective of getting help; the doctor makes an effort to make a clear diagnosis and gives the patient advice based on the diagnosis - but the patient does not follow this recommendation. How can this behaviour be explained?

First let us look at a real example:
A top manager had been feeling under stress for several months. He woke with a bit of a headache every morning as well as feeling slightly dizzy. As a result of pressure from his family, and because a large special project of the firm had to be completed, he visited his doctor. He did not really expect that anything dangerous would be found. Repeated blood pressure measurements showed readings about 190/120 mm Hg. The diagnosis appeared to be long-established hypertension. The doctor told him that the "raised blood pressure just had to be treated", as such levels were "very unhealthy"; in the worst case cardiac infarction, strokes and circulatory problems could result. Treatment with medication was started. The patient felt worse, although the blood pressure dropped into the normal range. He noticed increased tiredness, dizziness on rising, as well as decreased potency. He was told by the doctor that he "must definitely continue nevertheless" with the medication. It became more difficult to do what he had to at work. He took his medication less and less regularly, and did not feel so bad after all. One day it seemed as though the blood pressure problem was completely forgotten.
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Causes of non-compliance
Some of the most important causes of non-compliance can be seen in the example described above:
The expectations of the patient were not fulfilled. He was expecting to hear that he was basically healthy. Instead of that, he had to undergo a multitude of tests, accept a diagnosis of disease which he had not reckoned with, and to hear the advice that he had to take tablets "for the rest of his life".
There was a marked discrepancy between the subjective estimation of the severity of the illness and the objective findings.
The patient did not have the feeling that he was really threatened by his illness.
There was no major suffering.
A trusting relationship did not develop between the patient and the doctor who treated him.

Non-compliance is the result of demotivation in the sense of unsuccessful motivation. That a patient visits a doctor because he is seeking help, but does not follow suggestions for treatment, has been described by L. Festinger as the psychological phenomenon of cognitive dissociation theory. Everybody strives to be free of inconsistencies in his cognitive system. He wants cognitive elements to be consistent. If however two cognitive elements (opinions, beliefs, what is thought to be true) have contradictory contents, cognitive dissociation occurs which creates internal pressure. The cognitive dissociation is only resolved by removing the contradictions between the cognitive elements, and only this releases the internal tension.

If the patient has the impression that he is not ill and expects that his slight headache will only turn out to be an insignificant finding, but instead a moderate to severe hypertension is discovered and he is given the recommendation for life-long medication, this will lead to a cognitive dissociation. He is able to solve these internal contradictions between his opinion and his acceptance by non-compliance. The raised blood-pressure will be regarded as unimportant, a mechanism by which the contradiction is made to fit the original expectation, and as a result of which there is no need to take further medications.

Factors which can individually lead to demotivation also play a decisive role in non-compliance. Unsuccessful motivation can be traced back to the following causes:
Unclear formulation of the objective of therapy ("We must get the blood pressure down")
Impersonal arguments, universally applied ("It's not healthy to be overweight")
Hypothetical arguments ("It's possible that you will lose a leg one day because of the diabetes.")
Creating anxiety ("If you carry on smoking like this, I'll only give you 2 years more")
Exaggeration of the objectives ("You have to take these tablets 3 x daily from now on - at breakfast, lunch and supper - for the rest of your life to combat this problem")
Lack of willingness to compromise ("Either you follow this diet or ...")
Dealing in various realities (the patient finds himself in a life crisis which he would like to discuss, but receives instead a prescription for a trivial finding)

Groups working in America, Austria and Germany in the last few years have shown that factors which determine non-compliance can be placed in one of 5 groups:
1. Factors which are grounded in the behaviour and the personality of the doctor
2. Factors which depend on the patient
3. Manner and content of the doctor's instructions
4. Factors directly or indirectly dependent on the therapy
5. Factors which depend on the illness
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The doctor as a cause of non-compliance
The credibility of the person giving advice is a condition for the patient accepting this advice. The credibility is in turn dependent on the specialized competence which the patient ascribes to his doctor. However, even recommendations which are based on specialized knowledge are only accepted if there is a certain amount of trust between the patient and the doctor who is treating him. There is a clear correlation between the degree of compliance and the extent to which a patient trusts his doctor. If the patient has a negative picture of medicine, this will also have a negative effect on compliance.

Certain behaviour patterns on the part of the doctor are particularly likely to encourage non-compliance:
cool and distant approach
"routine" discussion
not answered questions
authoritative behaviour
not accentuating the importance of a prescription

The more that the doctor inspires a feeling of partnership and the less he uses authority, the more the patient is willing to accept recommendations. Questionnaires have revealed however that nearly 50% of all doctors believe in the authoritarian approach (R. Schoberberger, M. Kunze).

Further important causes of non-compliance are:
that the doctor is poorly or not at all motivated
that the instructions are not clear, or are misunderstood
attacks on the feelings of self-worth of the patient ("Others manage it faster than you")
strategies which use shock tactics, threats or create anxiety
overestimation of the effect of a certain type of therapy
insufficient involvement of the patient's responsibility and independence
increased authoritative pressure
cognitive or emotional over-loading by the doctor

A frequent cause of cognitive overloading is the over-estimation of the extent to which a patient can understand recommendations, as well as his attention span. By their own admission, 7-53% of patients do not understand what the doctor has told them. Studies have shown even higher percentages (53-89%), because the patients believe that they have understood a recommendation, even though this is not the case. Lay showed that the doctor's instructions were forgotten in a frighteningly high proportion of cases (28-71%), and the percentage rises as the number of items of information increases.

Factors which make non-compliance more likely 
A. Factors which lie in the person or the behaviour of the doctor: 
1. Authoritarian behaviour
2. Not fulfilling the expectation of the patient
3. Negative attitude
4. Poor motivation on his part
5. Overestimation of the therapeutic effect of treatment
6. Not taking into account the patient's sense of responsibility and independence
7. Attacks on the patient's self-respect
8. Overloading the patients' emotional or cognitive abilities
9. Attempting to motivate by inducing anxiety, shock tactics or threats
10. Instructions in specialized jargon
B. Factors which lie in the person or the behaviour of the patient: 
1. General negative attitude towards health
2. Risks to health not thought to apply
3. Marked tendency to prejudices and fixed ideas
4. Passivity
5. Hypochondria
6. Limited cognitive ability
7. Limited ability to concentrate
8. Fear of addiction to the medication
9._ Considers that the likelihood of side effects is high
C. Factors which lie in the instructions themselves: 
1. Incomprehensible
2. Excessive
3. Imprecise
4. Several different instructions
5. Instructions with "the raised index finger", "you must ..."
6._ Impossible instruction
D. Factors which depend directly or indirectly on the recommended treatment or changes in behaviour: 
1. Stressful or inconvenient forms of therapy
2. Limitation of quality of life
3. Shocking effect of the explanatory leaflet
4._ Type and extent of the side-effects
E. Factors which depend on the type of disease: 
1. "Image" of the disease
2.  Extent of suffering
3._ Objective severity of the disease
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Patient and non-compliance
Certain attitudes and preconceptions on the part of the patient are often the cause of poor compliance. It is usually very difficult to surmount these barriers, and it needs a particularly persistent long-term intervention. The basic problem is that nobody can be motivated against his will over a prolonged period, and attempts to motivate in the face of tendencies, prejudices and habits meet the greatest resistance.

The most important practical reasons for poor compliance, which lie with the patient are:
A generally negative attitude towards health; the lower the importance of health on the personal scale of values, the less the chance that he can be motivated to undertake medical treatment.
A playing down of the risks to health. This often arises from defense mechanisms. Although risks to health are accepted generally, they are not applied to the patient himself. It should be pointed out in passing, that this behaviour is very prevalent in doctors.
A high level of prejudices and fixed ideas. These are at the root of many pseudo-arguments such as:
- "Everything has been alright so far ..."
- "One can't live for health alone ..."
- "Why should I poison myself with lots of tablets ..."
- "I balance this with sport ..." etc.
A passive attitude. This can be favourized by excessively generous health insurance. Such a patient tends to accept therapy which does not involve the use of self-initiative, to put off important treatment and to put the responsibility for their health problems into the laps of others.
A high anticipation of side-effects. This depends on the type of medication, the extent of the explanation, on those around the patient, and not infrequently from the fear of becoming addicted to the medication. A representative sample of young people between 12 and 15 years old showed that nearly all believed that all medications have dangerous side effects.
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Instructions and non-compliance
Poor instructions are one of the major causes of non-compliance. The success of an instruction mostly depends on the content, but also the extent and the way it is formulated and given. The following forms of instruction are unsuitable for motivation:
The incomprehensible or misunderstood instruction. The more specialized terms are used, the more that the doctor uses "scientific" speech, and the more that the language of the doctor diverges from that of the patient, the more the instruction is likely to be misunderstood. Specialized jargon does not only include technical terms in the narrow sense but also general medical jargon. There are many terms which the doctor takes for granted as being used in normal speech, which can be completely incomprehensible for the patient ("regular application", "prognostic significance", "ubiquitous effect").
The excessive instruction: the more information that an instruction contains, the more the likelihood of misunderstandings and the higher the extent to which it will be forgotten. It is difficult for a patient facing an illness for the first time to sort out the importance of each instruction when they are multiple. The order in which instructions are given plays a role in the way they are remembered; a recommendation given at the beginning is twice as likely to be remembered as one in the midst of a series of instructions.
The imprecise instructions: this does not only mean imprecision of an instruction and the lack of quantitative information, but also instructions that the doctor would not think could be misunderstood, but which can mean something else to the patient, such as:
"You should phone immediately if side effects occur ..." instead of "if the motions become black ...", "if you become feverish ...", "if you notice a rash ..."
"Often put your legs up" ("How often?", "For how long?", "How high?") 
"If you become infected, you must increase the dose ..." (instead of "If you cough, or have a cold or fever ...")
So-called "broad-spectrum instructions". Here recommendations are so imprecisely formulated and so general that it is questionable whether they can be followed at all:
"Don't let things get on top of you, even though it's bad." 
"Stress is very bad for you, so try to avoid it whenever possible, both at work and at home." 
"Try not to take everything to heart."
Instructions delivered with the index finger raised. Lecturing or preaching (instead of recommending actions based on appropriate facts) does not usually result in sustained effects. The danger of the so-called "pulpit syndrome" is that either the words delivered from above do not fall down or are not picked up from below, and are of little effect in either case.
The illusionary instruction: this acts against the principle that the objective of motivation not only has to be recognizable and worthwhile, but also attainable. The most common causes are attitudes to illness from differing realities, overestimation of the efficacy and usefulness of a procedure or unilaterally pushing of a certain form of therapy. Although taking 18 tablets a day can be fully justified on pharmacological and pathophysiological grounds, this usually fails in practice.
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Recommendations for therapy and behaviour as the cause of non-compliance
The way in which therapy or changes in behaviour are recommended is also decisive in the extent of compliance. A high non-compliance is to be expected where:
The type of therapy is stressful or requires special effort: For example, most medications are supposed to be taken at times which do not fit into a daily routine (i.e. 8 am, 4 pm and midnight); some recommendations may not fit individual situations of the patient (at work, during journeys, shifts), or may actually interfere in daily life (dosed aerosols, suppositories, drops). The taste, shape and size, and smell of medications also play a role.
Procedures which affect "quality of life" to a significant degree; this includes all recommendations which affect consumption or behaviour during time off.
Formulation of the information in the leaflet accompanying medications; the detailed list of all of the possible side-effects has a shocking effect. Reports which appear in the media, along with an increasingly critical approach on behalf of patients which strengthens the desire for information, mean that the explanatory leaflet becomes more and more a source of uncertainty and nurtures a suspicious behaviour towards medication. In spite of extensive opinion to the contrary, actual side-effects have very little influence on non-compliance. Studies have shown that side-effects (at 5-10%) were at the bottom of the list of causes of non-compliance. Other controlled investigations have shown that side-effects occur to the same extent in both those who can be relied on to comply and those who cannot.
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Illness and non-compliance
It has not been clearly shown whether or not there is a relationship between compliance and the objective severity of the illness. Correlation between the severity of the illness and the extent of compliance was shown in only 6 out of 13 studies. It seems as if a milder degree of suffering encouraged non-compliance. Compliance is especially poor in psychiatric patients with a schizophrenic personality structure.

There is some discussion about the relationship between the "image" of a disease and compliance. Illnesses which with the general public have a high "attractively" (such as cardiac disease and multiple sclerosis) are probably associated with a higher degree of compliance than "unattractive" diseases, even if they rank high in social medicine (i.e. hypertension, respiratory disease).
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Measures which can encourage compliance
A seminar attended by both doctors and patients (Eltville, 1985), gave patients an opportunity to formulate their idea of the "ideal doctor", and also to consider what was more likely or less likely to produce compliance. Summing up the extensive range of suggestion doctors should:
not be a school master, but still be able to be authoritative,
probe into the patient's personality,
be somebody that could be respected as an example,
praise the patient,
able to awake hope that the therapy will be effective,
give strength at the point where the patient could not continue any longer (trusted confident, helper, psychologist),
make the illness and the therapy understandable for the patient,
give the patient the opportunity to present his own view of the illness and his experience of it.
In other words: patients are most likely to follow the recommendation of the doctor, if he:
shows empathy,
approaches the situation from that particular patient's particular stand-point,
gives comprehensible and well-founded recommendations,
stands at his side.
The art of attaining the most optimal compliance possible finally rests on exhausting all of the measures which encourage motivation (see chapter on motivation link) and on clearing away as many factors which lead to non-compliance as possible.

Various sorts of supporting measures can also be used to achieve improved compliance. The involvement of a partner or an other key-person in the therapy plan plays a particularly important role, especially in the case of old or handicapped patients where social isolation leads to a marked reduction in compliance. The best person is one who is most concerned about the state of the patient's health and who is acceptable to the patient. This can be a spouse, another relative, a neighbor or a nurse. Involving this key person in the therapy plan with regard to the non-medical measures (diet, physical activity, cutting down on smoking etc) has a clearly motivating effect.

Factors which increase compliance 
A. Ground rules: 
1. The patient must know what the objective is, and that it is both attainable and worthwhile
2. Present positive consequences
3. Motto Victory is possible!
4. Take risks and failure into account
B. The optimal tool: 
1. Instruct: precisely, simply, comprehensibly, focusing on this particular patient
2. Present a standard
3. One recommendation is more likely to be followed than several
4. The simplest measure is the most effective
5. Advice tailored to the situation
6. "One step at a time"
C. Supporting measures: 
1. Written information as memory aids
2. Encourage checking one's self
3. Introduce a helpful person
4. Encourage independence and self-responsibility
5. Show willingness to compromise
Agreeing appointments for checking progress has a cumulative effect: not only does this support the patient in the belief that the doctor is really concerned about him and interested in his progress, but it also affords the doctor the chance to check compliance.

Compliance can be checked not only by signs of the major pharmacological effect on the patient (i.e. lowering of blood pressure), but also by the observation of specific side effects (pulse rate with beta-blockers). Other expensive or non-routine investigations such as blood level determinations (digoxin, theophylline, phenytoin or tests for HbA1) are of limited value for estimation of compliance. D.L. Sackett, one of the leading American researchers into compliance, believes that direct questioning of the patient is the best method of checking compliance. Questions such as: "Many people find it difficult to remember to take their tablets regularly. Do you find that you sometimes forget to take your tablets?" are usually answered. However even though optimal compliance is an important objective of the efforts of a doctor, it is just as important to remember that ability and willingness to compromise is just as an effective tool for guiding the patient. 

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Linus Geisler: Doctor and patient - a partnership through dialogue
© Pharma Verlag Frankfurt/Germany, 1991
URL of this page: http://www.linus-geisler.de/dp/dp15_compliance.html
 
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