Competence Research Paper

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Abstract

Competence is a key concept of bioethics with rich interdisciplinary and practical connotations. After offering basic conceptual clarification, its clinical significance is illustrated by referring to empirical studies. Exploring the ethical dimension of competence reveals that it cannot be studied without acknowledging the doctrine of informed consent and, more recently, the rule of shared decision making in medicine and health care. The definition of the ideal concept of competence is reflected including the standards and norms that it is setting as well as the exceptions to the rule – i.e., people with diminished competence comprised in large groups of the population such as young children, old and demented people, cognitively handicapped persons, or severely ill patients. They, too, have rights and deserve being respected, even in the absence of (full) decisional competence. In bioethics, medical ethics, and clinical ethics, the topic of competence plays an important role regarding patient rights, shaping the attitude of health-care professionals, and influencing the ideas of appropriate treatment decision making. Practical challenges concern the assessment of a person’s competence. In a global perspective, it is suggested to open up the spectrum of competency research beyond

Introduction

The understanding of competence as mirrored in the bioethics literature is characterized by a focus on the medical, especially clinical context, as well as on research and, thus, on the challenge to identify limitations among patients whose ability to make decisions may be compromised. In the presence of critical and intensive care as well as organ transplantation and other high-cost medical interventions, a focus on treatment decisions – of patients – displays a tendency toward taking “Western,” industrialized and affluent countries as models, rather than studying the developing world. In a global perspective of bioethics, however, competence should be addressed as well or even primarily in light of the resources and structures allowing individuals and groups to develop and practice their competence. Ideal conditions and circumstances for building competence regard the following: a political system that guarantees peace and safety; an environment and agriculture providing drinking water and food for all; accessible, unrestricted education through childhood and adolescence; and job opportunities and sufficient income to earn one’s living and feed a family. People can, of course, even under adverse conditions, use their existing competence for making decisions and choices, acting with oversight and responsibility. But in the absence of basic resources and structural conditions, both developing and exerting competence are seriously at risk. Taking these considerations seriously drives bioethics from a merely patient care-oriented discipline toward a human rights perspective.

Background, Conceptual Clarification, And Definition

The concept of competence has gained great significance in modern health-care and bioethics. This acknowledgment emerged alongside the establishment of the praxis of informed consent as a basic patient right. However, medicine as a whole is not the only societal system where competence plays a key role for supporting human rights; but it does serve as a paradigm field to document the efforts made here to address the understanding, assessing, and respecting competence in persons, despite multiple challenges. Other societal contexts dealing with competence beyond the health-care sector are legislation, jurisdiction, executive power, politics, education, and economics.

In the following chapter, competence will be addressed from the perspective of medicine and human research.

The terms “competency” and “competencies,” often used interchangeably, may be defined as the behaviors that individuals must have, or must acquire, to perform effectively at work. Being competent is defined as the quality of having sufficient knowledge, judgment, skill, or experience for some purposes. The reasons for assessing competency vary. Assessing the patient’s competency is particularly important because an individual can be considered competent for certain issues and incompetent for others. In hospital settings, a frequently encountered situation is the assessment of a patient’s competence to give informed consent for a treatment or medical procedure as well as clinical research. When the patient agrees with the therapeutic goals proposed by the medical team and goes along with the planned treatment, the competency question is usually not raised. Only when she/he refuses treatment or wants to leave the hospital against medical advice, competency assessment becomes relevant. Physicians are required by law and principles of medical ethics to obtain informed consent from a patient before initiating any therapy. Valid consent (also known as “free and informed consent”) must include the following three elements: adequate information, voluntariness, and competence. The consent is based upon the disclosure of appropriate information to a competent patient who will make a decision. When the patient is lacking competence, substitute decision makers must be sought according to national legislation (e.g., relatives).

Competence as a legal term can only be determined by the courts. In clinical practice, the assessment of competence is in the hands of several disciplines: psychiatrists, forensic experts, psychologists, clinical ethicists, or interdisciplinary groups. Competence is issue/task specific and refers to the degree of mental soundness necessary to make decisions about a specific issue or to carry out a specific act.

Incompetence is defined by one’s functional deficits (e.g., due to mental illness, mental retardation, or other mental condition), which are judged to be sufficiently great that the person cannot meet the demands of a specific decision-making situation. Incompetence is determined by the courts as well. Legal incompetence is task specific (somebody can be competent to consent to high-risk surgery, but incompetent to make a will or vice versa); ascribing legal incompetence depends on the consequences, and it can fluctuate over time.

Capacity is defined as an individual’s ability to make an informed decision. A consultant psychiatrist can help the clinical team (or the courts) in the evaluation process when determining the capacity of such individuals to act in the matter in question. It may be a difficult task to assess a patient with a history of psychiatric disorder who refuses diagnostic or treatment procedures proposed (e.g., patient diagnosed with mild depression refusing amputation for a gangrenous leg).

Experts may face moral dilemma when assessing a patient’s capacity to make a medical decision. A study investigating competency by psychiatrists showed that half of the consults were requested to inquire about competency to return home and manage finances, a quarter about competency to provide informed consent, and the rest were requested to determine competency to refuse treatment or to consent to medical procedures. Patients were referred less frequently to psychiatric consultation for competency to self- care or desire to leave medical institution (Umpathy et al. 1999). Another study dealt with the characteristics of the patients who were referred for competency assessment to give informed consent for medical procedures (Weinstock et al. 1984). Their main diagnoses were organic brain syndrome, schizophrenia, depression, personality disorder, and no diagnosis. From 30 consultations, only 10 patients were considered to be incompetent by the psychiatric team, all of them with organic brain syndrome. These consultation requests were generally made for patients who refused treatment.

When a patient refuses medical treatment, the laws of the UK, the USA, and Canada, as well as of many other countries, require that his or her wishes should be respected unless the patient can be shown not to be legally competent. Legal competence requires that the individual has capacities to reason and deliberate, to hold appropriate values and goals, to understand information, and to communicate a choice. These capacities can change over time, so medical procedures which require consent over extended periods necessitate repeated assessments. The law recognizes that mental capacity is a continuous quality that may be present to a greater or lesser extent.

But legal competence cannot be present to a greater or lesser extent, although this seems to contradict a more psychological understanding. A person is either entitled or not entitled, at law, to have their wishes respected regarding treatment. Physicians, patients’ relatives, and, in contested cases, the courts have to decide, where someone’s right to accept or refuse treatment is in doubt, whether that person’s mental capacity is sufficient for legal competence, and their wishes should therefore be respected. The criteria that govern the competency to accept or refuse treatment refer to the following: the patient should understand the information given to him or her and have capacity of reasoning, as well as appreciate the situation and its likely consequences and be able to express a choice. At the same time, the patient should understand the proposed treatment with its risks and benefits, the alternative treatments, and the possible outcome if she/he refuses treatment. The understanding can be impaired in cases of low IQ, mental retardation, dementia, poor education, poor attention, or aphasia and also when delusions, suicidality, and confabulation are present. Ambivalent patients or the ones who have communication difficulties may not be able to express a choice or preference for a certain treatment. The abovementioned limitations of competence refer to “inner” functions or characteristics of the individual. However, also external influences such as interests expressed by significant others, threats, or conflicts may result in diminishing the decisional capacity.

With regard to research involving humans, capacity refers to the ability of prospective participants to understand relevant information presented about the study and to appreciate the potential consequences of their decision to participate or not. This ability may vary according to the complexity of the choice being made, the circumstances surrounding the decision, or the point in time at which consent is sought. Assessing capacity is a question of determining whether a prospective participant sufficiently understands the nature of a research project, its risks, consequences, and potential benefits.

The legal implications of competency and capacity issues strengthen a clearly individual conceptualization. However, in both patient care and research, individualistic approaches are not sufficient, which is particularly true in communal oriented societies where the family and the social groups play an important role in consulting with and influencing the individual who is to make a decision. However, it does apply also to Western, industrialized, and affluent countries. Public and International Health acknowledge this fact – more than clinical medicine used to do. But the “ethics” of Public and International Health is still to be elaborated, compared with the extended theories of individual bioethics.

Ethical Dimension: The Norm And Its “Exceptions”

When analyzing the concept of competence, the definition of the ideal concept sets standards and norms for what competence means, that is, which characteristics allow calling a person competent. At the same time, the definition includes implications about the deviations from the standards and norms, thus establishing potential exceptions. In the absence of reasons to do otherwise, we consider every adult person competent to make decisions: to train, to practice religion, to vote, to enter a career, to marry, to have children, to travel or migrate to another country, to see a physician for treatment, etc. If the competence to do so shall be questioned, serious reasons are required to argue that the person cannot make that specific decision. Economic, political, or cultural reasons may impede individuals to exert their existing competencies; they may have insufficient access to education, be restricted to practice their faith, or be hindered to travel abroad. There may be medical interventions superimposed on them against their wishes or available treatment options withheld from them despite medical need. Thus, the normative view that without good reason every adult person has to be considered – and treated as – competent does not always mirror the reality.

Competence In The Adult Person: Criteria And Problems

Every medical intervention (except emergency care) requires the competent patient’s consent. The informed consent expresses the society’s respect for the patient, in terms of how treatment, if any, will be provided. The aim of informed consent is to offer the patient an opportunity to be an informed participant in his or her health-care and make decisions. It is generally accepted that informed consent for any medical procedure or treatment includes an acknowledgment of the following elements (Beauchamp and Childress 1994):

– Discussing the nature of the procedure/intervention with the patient

– Offering reasonable alternative options other than the proposed intervention to the patient

– Discussing the relevant benefits, risks, and

uncertainties related to each alternative option with the patient

– Assessing the patient’s understanding

– Asking the patient for acceptance of the procedure or intervention

This list shows that respecting the patient’s right to give informed consent is very similar to the concept of shared decision making and, thus, counseling the patient, rather than just presenting information and leaving the patient alone with the decision to be made. Moreover, for a valid consent, the patient must be considered competent to make the decision, and the consent must be given voluntarily. In practice, this means that the consent must not result from coercion, manipulation, or undue inducements.

Patients often feel powerless and vulnerable. For example, people might believe that if they do not agree with the therapy proposed by the care team, this will be to their disadvantage and will affect the relationships with treating physicians or other therapists. Vulnerability is an important concept in medical and research ethics, defined as being the incapacity to articulate and protect one’s own interests. Groups who are held as being vulnerable are those with limited capacity to give or to decline consent such as children and young people, mentally ill persons, and those with learning disabilities or other disadvantages such as elderly persons with dementia. There are cases where patients are unable to grant informed consent: the Universal Declaration on Bioethics and Human Rights states that “Authorization for research and medical practice should be obtained in accordance with the best interest of the person concerned and in accordance with domestic law. However, the person concerned should be involved to the greatest extent possible in the decision-making process of consent, as well as that of withdrawing consent” (UNESCO 2005). In order to encourage voluntariness, physicians should make clear to their patients that they are participating in a decision-making process in benefit of their health. A physician is also generally obligated to provide a treatment recommendation and share his or her reasoning process with the patient. Comprehension on the part of the patient is equally important as is the information provided. Consequently, the discussion should be carried out in layperson’s terms, and the patient’s understanding should be assessed continuously.

Patient Groups With Challenged Competence: Mentally Ill, Handicapped, Demented, And Comatose Person

Patients with impaired or challenged competence are commonly found in medical and surgical inpatient hospital units or nursing homes and less frequently in outpatient clinics. Between 3 % and 25 % of the requests for psychiatric consultation in hospital settings aim at the evaluation of the patient’s competence to make treatment related decisions. A study (Raymont et al. 2004) showed that 48 % of the patients suffering from neurologic and infection diseases were incompetent to consent for medical treatment. Any diagnosis and treatment that compromise the patient’s mental health state may be associated with incompetence. Studies of decisions investigating both consent to receive treatment and consent to participate in clinical research showed a high rate of incompetence in Alzheimer’s disease and other dementias, in mild–moderate dementia, and incompetence of patients with severe dementia. The strongest predictor for the alteration of a person’s capacity is considered to be the lack of insight, the lack of awareness of illness, and need for treatment (Ruissen et al. 2012). Medical conditions such as unstable angina, diabetes mellitus, and HIV have not been found related with the impairment of decision making as well as less severe depression which seems not to impair capacity. It has been proven that cancer patients have variable performance in competence assessments, the impairment in decision making being correlated with age, lack of education, and cognitive impairment (Palmer et al. 2005).

When dealing with people whose ability to make choices is doubtful due to severe illness, the clinical team should take extra precaution to make sure that the rights and wishes of the patient are respected (Winkler et al. 2009). Treating a patient who is unable to grant informed consent requires, according to the principle of respect for person, the duty on the side of the health-care professional (or researcher) to act for the benefit of the patients’ interests while safeguarding his/her autonomy and ability to make an informed decision in accordance with his/her personal capabilities.

Young Persons And Their Rights

Children And Mature/Emancipated Minors, Recent Research On Children’s Competence, And General Approach/Legal Standards For Determining A Minor’s Capacity To Consent

According to the General Medical Council (GMC). Consent guidance: Involving children and young people should be involved as much as possible in decisions about their care, even when they are not able to make decisions on their own. Numerous empirical studies suggested that children have much more competence than has been recognized by the legal community. Adolescents and even younger children are capable of understanding and decision making like adults. It appears that children as young as about 12 have a factual understanding and appreciation for the risks and benefits of complex treatment, e.g., psychotherapy. Even 9-year-olds appear to understand the basic aspects of the treatment, including differences between various diagnoses and prognoses, and treatment risks and benefits. Twelve-year-olds are able to define accurately many basic legal concepts; thus, allowing children to participate in decision making regarding their own health may enhance children’s perception that they have been treated fairly. Also, it improves the treatment by increasing the child’s adherence to the proposed intervention leading to positive attitudes about treatment and fostering appropriate expectations.

Minors have generally been viewed as being incapable of making decisions; though, some groups of minors were allowed by law to consent, independent of their parents’ consent or knowledge, to certain medical services. However, the concept of informed consent has limitations when it is applied in pediatric care. Only competent minors with legal empowerment have the ability to give true informed consent to medical treatment. Related to this issue, the minor’s right to dissent has recently been discussed as an ethical issue in mental health practice, both in treatment and in research participation (Hickey 2007).

Many times the competent minor’s wishes regarding medical treatment incidentally coincide with those of the parents. Problems appear when they disagree with regard to the matter in question. As stipulated in ethics codes, the right of the minor’s dissent should be respected, but some mental health professionals refer to a minor’s right to consent primarily in the sense of a “right to know” or a “right to participate” when their treatment is being decided, not in the sense of a veto power.

Legally, adolescents have the right to make decisions on their own, if they are competent to do this. If a child or adolescent is deemed not legally competent, consent will need to be obtained from someone with parental responsibility; it means that the minor is allowed to give his or her assent being followed by the consent of the appropriate adult. The assent process should include the following:

  1. An appropriate explanation of the medical condition and the treatment according to the minor’s development and understanding level
  2. An assessment of the minor’s understanding of the information and how his or her decision was made
  3. An expression of the minor’s willingness or unwillingness to allow treatment

Ethically, health-care professionals have the duty and responsibility to protect the rights of minors by assuring that they are well informed and involved in the decision-making process, that confidentiality is protected, and that respecting their rights does not result in harm to the adolescent or to others (Convention on the Rights of the Child 1989).

Competence here is seen as a specific, not as a global concept; thus, the question to address is whether a minor is competent to make a particular decision in a determined situation, given particular circumstances. Generally, different aspects must be taken into account when determining or judging the competence of a minor: age, experience, degree of maturity, judgment skills, minor’s behavior, evidence of separateness from parents, and the particular facts in the minor’s case. Many adolescents are competent in that they possess qualities associated with self-determination: cognitive ability, rationality, self-identity, and ability to reason hypothetically.

The legal determination of “majority” has been defined by chronological age, this being 18 in majority of European countries, whereas the ethical determination of minors’ decision-making capabilities is much more complex. Judgments about minors’ competence can only be made case by case, taking account of the individual child, the type of decision, and the circumstances. Determination of a minor’s competence for medical decision making should include evidence that the young person has the ability to understand the purpose of treatments, risks, both long and short-term consequences, benefits, and alternative options to certain treatments. In addition, evidence must be present to ensure that the minor is able to make an informed decision without coercion.

– Children aged 16–18

Once children reach the age of 16, they are presumed by law to be competent. In the UK, patients aged 16–18 are permitted to give their consent to surgical or medical treatment, but they cannot refuse treatment if it has been agreed by a person with parental responsibility or the court and it is in their best interests. If a competent child requests that confidentiality be maintained, this should be respected, unless the physician considers that not disclosing the respective information would result in significant harm to the child (Hiriscau et al. 2014).

– Children under the age of 16

Children in this age group are not deemed to be automatically legally competent to give consent. They can be legally competent if they have “sufficient understanding and maturity to enable them to understand fully what is proposed” (Levy et al. 2003). The children under 16 may be allowed to consent to medical procedures if they are deemed mature enough to understand the nature and implications of clinical treatment or procedure, can appreciate foreseeable consequences, and make competent decisions in question.

Normally, the parents have the right and duty to make decisions regarding medical treatment for their children, but there are circumstances where the law allows an “emancipated minor” to receive treatment without parental consent. The minors can give consent on the basis of their “status” or on the “medical service” they are seeking. A minor pregnant, married, enrolled in the army service, having children, living apart from parents, being on his/her own financially, or being the victim of an abuse or sexual assault may consent to medical care and counseling alone and without parental interference. They can benefit of medical services such as venereal disease treatment or HIV testing; contraception, prenatal care, or abortion; mental health treatment; emergency care; and treatment for alcohol or drug abuse (after age 12). The “Mature Minor Doctrine” represents a conceptual framework in which a competent minor can make treatment decisions without parental or guardian consent being required.

A minor who is deemed able to understand short and long-term consequences is considered to be “mature” and thus able to provide informed consent – as well as refusal – for medical treatment. This “maturity” authorizes the minor to make decisions regarding his or her medical treatment; however, it does not provide a “carte blanche permission” for minors to generally make decisions regarding medical treatment without parental consent. There are specific circumstances in which the mature minor is allowed to consent alone for treatment: the minor is an older adolescent and is capable to give informed consent; the treatment will benefit the minor, it does not present a great risk for the minor, and it is within established medical protocols (Hickey 2007).

Although parents and guardians have the right to make decisions on behalf of the child, the state has the responsibility to protect the health and well-being of the minor. The parens patriae is a doctrine that grants the inherent power and authority of the state to protect persons who are legally unable to act on their own behalf. That means that the state, acting as parens patriae, can make decisions regarding mental health treatment on behalf of one who is mentally incompetent to make the decision on his or her own, but the extent of the state’s intrusion is limited to reasonable and necessary treatment.

Assessing Competence: Guidelines And Models

Currently, no practice guidelines exist from professional societies for the assessment of a patient’s capacity to consent for treatment. In patient care, limitations of a patient’s competence are more often assumed and discussed than systematically assessed.

Regarding capacity to consent for research, ethics codes and guidelines stipulate dispositions and recommendations when the participants are considered not able to give their consent. In this respect, the CIOMS, guideline 15, referring to the research involving individuals who are not capable of giving adequately informed consent, states that “the willing cooperation of such persons should be sought to the extent that their mental state permits, and any objection on their part to taking part in any study that has no components designed to benefit them directly should always be respected” (CIOMS 2002). A prospective subject’s refusal to participate in research always has to be respected. In cases where prospective subjects lack capacity to consent, permission has to be obtained from a responsible family member or a legally authorized representative in accordance with applicable law. Some jurisdictions do not permit third-party permission for subjects lacking capacity to consent. The reason for limiting the involvement of proxies, who may have their own interests, is the protection of the patient’ rights and welfare.

Models Of Competence

Various models defining competency for treatment decision making have been developed based on general standards adopted and incorporated in various statutes. These standards are:

  1. Factual understanding of the problem and the treatment alternatives – requires an understanding of the diagnosis and the psychological nature of the illness, treatment alternatives, and their probabilities of success, the risks, and benefits of each alternative.
  2. Rational decision-making processes – may include a determination of whether the person has weighed the risks and benefits, calculated the probabilities, provided sound reasons, or generally shown adult problem-solving capacities.
  3. Appreciation for the personal implications of the decision – requires the acknowledgment of the relationships between various alternative options to one’s own values and present as well as future life situations and the ability to draw inferences and think abstractly about future consequences. Thus, appreciation seems to require not only adult-like cognitive skills but adequate emotional maturity as well (it has been generally accepted that these three standards represent increasing levels of maturity).
  4. Ability to make and communicate a choice – requires only that the individual communicates a choice.
  5. A reasonable choice – evaluates decision making according to the outcome, requiring that the choice be reasonable and not the product of mental illness.
  6. General competence – which may be determined with reference to diagnosis, appearance, or prior behavior

General competency has been proposed as a threshold standard, with one of the other specific competency standards as an added test. Regardless of the standard used, however, it is generally recognized that competency includes at least a factual understanding of the illness and treatment alternatives, including their risks and benefits, and the capacity for rational decision making. Most minor consent statutes require an understanding and appreciation of the nature and consequences of treatment alternatives.

Practical Dimension: Determining The Capacity To Consent

Legal standards for decision-making capacity for consent to treatment, generally, embody the abilities to communicate a choice, to understand the relevant information, to appreciate the medical consequences of the situation, and to reason about treatment choices. According to these criteria, the patient should be able to express clearly the preferred treatment choice; to grasp the fundamental meaning of the information communicated by the physician; to acknowledge the medical condition and likely consequences of the treatment options, respectively; and to engage in a rational process of processing and using the relevant information.

Given the requirement of competence for valid informed consent, the assessment of the patient’s capacity to make decisions is an intrinsic aspect of every physician–patient interaction. In the absence of any reason to question a patient’s decision making, the presumption of competence has to prevail. When an explicit competence evaluation is required, physicians should be aware of the relevant criteria and be encouraged to use a structured approach to assessment. Studies showed that the use of a systematic set of questions for competence assessment led to a high rate of agreement with expert judgments.

The Mini-Mental State Examination (MMSE) has been found to correlate with clinical judgments of incapacity and to identify patients at the high and low ends of the range of capacity, especially among elderly persons with some degree of cognitive impairment. The MMSE is a simple psychometric tool that helps clinicians to ask and rank patients’ responses to questions that inquire into their mental “status.” It addresses questions that have to do with orientation and also basic perceptual and mental skills. MMSE scores range from 0 to 30, and the scores of less than 19 are highly likely to be associated with incompetence. Although extremely popular and practical, the Mini-Mental State Examination is now thought to be too global and general for a proper assessment of a patient’s mental capacity to make treatment decisions. One of the assumptions that underlie decision-making capacity is that this capacity is decision relative that means that assessments of capacity must now be more “case specific” and responsive to “situational variations in demands” (Grisso and Appelbaum 1995). Thus, “decisional relativity” requires that the assessment of the mental capacity to make a treatment decision must be directly tied to a particular decision, for a particular patient, and at a specific place and time. In this regard, the most widely used instrument is the MacArthur Competence Assessment Tool for Treatment, a structured interview that, unlike many other assessment instruments, incorporates information specific to a given patient’s decision-making situation. Quantitative scores are generated for all four criteria related to decision-making capacity, but evaluators must integrate the results with other data in order to reach a judgment about competence. In a global perspective, it can be postulated that an individualistic conceptualization of competence as it has been developed in the Western Hemisphere has helped to emphasize the importance of human rights especially in medicine and health care. However, a merely individualistic interpretation of decision making and its ethical significance is of limited value for developing countries when those who would like to make their own – competent – health-care decisions suffer from lacking basic requirements to develop or apply this ability. Poor resources or insufficient access to education and information, threats to peace, and security are external factors that cannot be compensated by individual competence alone, but require structural answers.

Conclusion

Human rights and patient rights build on concepts such as competence. Medicine, health care, and psychology have made major efforts to understand, describe, and evaluate aspects of individual competence. While this has been and had to be done in line with a normative concept of an average person – adult, educated, and intelligent – various kinds of anthropological exceptions to the rule exist in large groups of the population: young children, old and demented people, cognitively handicapped persons, or severely ill patients. They, too, have rights and deserve being respected, even in the absence of (full) decisional competence. In clinical care as well as in law, alternative decisional models relying on the presumed patient wishes, the patient’s advance directives or substitute decision makers have been established to serve this goal. Indeed, all sectors of society need to take care for safeguarding the respect for the rights of people whose decisional competence may be impaired. More research is needed to enrich the vastly individualistic concepts of competence used so far to guide decisional processes in medicine and health care toward including more societal aspects.

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