Competency to Consent to Research and

Treatment

William WatsonForensic Neuropsychology

July 6, 2006

Medical Consent

1914 Schloendorff v. New York Hospital

An individual has the right “to determine what shall be done with

his own body.”

Informed Consent

1947 Nuremberg Code• Voluntary

• Free choice

• Adequate understanding

• Capacity to give consent

Competency vs. Capacity

• Competency denotes a legal status as judged by a legal professional

• Capacity denotes a clinical status as judged by a health care professional

• An individual’s capacity may lie anywhere on a continuum but competency is binary

• Abilities are treated as task-specific dimensions

Florida Statutes

• Individual has unique needs and differing abilities

• Permits incapacitated persons to participate as fully as possible in all decisions affecting them

• Assistance that least interferes with the legal capacity of a person to act in her or his own behalf.

• This act shall be liberally construed to accomplish this purpose

Legal Standards for Competency

• Appelbaum and Roth (1982)– Evidencing a choice– Factual understanding of the issues– Rational manipulation of information– Appreciation of the nature of the situation

Case Example 1• Patient suffers from depression with catatonic features –

including mutism • The prescribed treatment is ECT• Patient doesn’t seem to object• ECT is administered• Upon recovery pt sues because of resulting memory

impairments• The patient’s guardian gives the go ahead

Evidencing a choice

Case Example 2

• 72 year old woman has mild Alzheimers dementia• She wants to participate in a clinical trial for a new

drug Aricept • Her MMSE is 22• When asked she can repeat back the risks and

benefits as well as alternatives to the trial

Factual Understanding of Issues

Case Example 3Suzanne is a 19-year-old college student who maintains a dangerously low weight. One night she collapsed and was brought to the ER by friends. She received glucose and was gaining enough strength to demand to go home when her parents arrived. Her parents insisted that the physicians keep her because her behavior was more or less suicidal. Suzanne’s physician consults you to help decide whether involuntary admission and artificial nutrition are called for. Suzanne could understand information she was given; she could analyze and measure the consequences of her refusal to treatment against an internal set of values and goals; and she could give back her decision in a coherent way.

Appreciation of Nature of the Situation

Case Example 4A 34-year-old man with paranoid schizophrenia has been diagnosed with lung cancer. His attention, language, and memory are intact. However, he has no insight into his mental illness. His delusions include a belief that he had a computer chip implanted in both of his ears and that people were pushing buttons on the implants to cause the tumor growth in his lungs causing the cancer. The patient understood and appreciated the personal significance of the following information: (1) that he had the lung cancer; (2) the nature and course of the cancer; (3) the risks and benefits of the chemotherapy that his doctors had prescribed; and (4) the risks of foregoing treatment. However, he had quit the chemotherapy because he believed the best treatment would be for his doctors to surgically remove the computer chip implants. He said that in order to protect his health; he would be willing to resume chemotherapy, as soon as the implants were removed.

Rational Manipulation of Information

Issues in Assessment of Competency

• Repetition without comprehension

• Poor performance on measure doesn’t necessarily mean poor ability in construct

• Tell us what we want to hear

At Risk Populations for Competency Issues

Alzheimers

Depression

Schizophrenia

Anorexia Nervosa

Assessing CompetencyThe Mini Mental Status Examination (MMSE)Hopkins Competency Assessment Test (HCAT)Capacity to Consent to Treatment Instrument (CCTI) MacArthur Competence Assessment Tool – Treatment (MacCAT-T)MacArthur Competence Assessment Tool – Clinical Research

(MacCAT-CR)Competency Interview Schedule (CIS)Structured Interview for Competency/Incompetency Assessment

Testing and Ranking Inventory (SICIATRI)Evaluation to Sign Consent (ESC)Aid to Capacity Evaluation (ACE)California Scale of Appreciation (CSA)Capacity Assessment Tool (CAT)

Mini-Mental Status Exam (MMSE)

• Commonly used tool to assess competency• Fairly inaccurate• 26 cutoff score – high sensitivity • 19 cutoff score – high specificity• Mid range is problematic• Lowering cutoff will correctly classify most

people but falsely classify others

Pros• Inexpensive• Widely usedCons• No MMSE cutoff produces both high

sensitivity and high specificity

A blunt instrument for assessing competency

Mini-Mental Status Exam (MMSE)

Hopkins Competency Assessment Test (HCAT)

• Assesses understanding and comprehension• Essay explaining informed consent process

and power of attorney (written at different grade levels)

• 6 questions regarding essay • T/F and sentence completion• Self report • 10 min

Hopkins Competency Assessment Test (HCAT)

Pros• Quick and straightforward• Can be administered by non-clinicians• High specificity/sensitivity in some samples• High inter-rater reliability• Good agreement with physician judgments• Can detect changes in understanding over timeCons• Only assesses understanding

Capacity to Consent to Treatment Instrument (CCTI)

• Developed for Alzheimers Disease• Contains 2 Vignettes about medical problems

– Symptoms– Risks and benefits of 2 treatment options

• Assesses choice, understanding, appreciation, and rational thinking, + reasonable decision

• Semi-Structured interview • 15-20 min

Capacity to Consent to Treatment Instrument (CCTI)

Pros• Well validated instrument

– differentiated controls from AD• High inter-rater reliability

– Physicians able to make reliable judgments of competency

Cons• Vignettes may not elicit same responses as

personal medical problem

MacArthur Competence Assessment Tool – Treatment (MacCAT-T)

• Assesses choice, understanding, appreciation, and rational thinking

• Adequate, partial, or inadequate ratings for each item

• Score for each ability• Not designed to determine global competence• Intended to identify areas of relative capacity• Semi-structured interview • 15-20 min

MacArthur Competence Assessment Tool – Treatment (MacCAT-T)

Pros• High inter-rater reliability• Correlates with MMSE• Utilizes patient chart to make test personally relevant• Moderate agreement with physician ratings• Practical for cases of ambiguous competency

Cons• May not be valid in every population: anorexia nervosa• Procedure for going over the facts of disorder and

treatment “Patronizing” and “Awkward”

MacArthur Competence Assessment Tool – Clinical Research (MacCAT-CR)

• Assesses choice, understanding, appreciation, and rational thinking

• Structured interview • 15-20 min

Pros• Can be customized to research protocol and

diagnostic sample• High inter-rater reliability• Correlates with MMSE

Cons• Possibly low test retest reliability – ceiling effects

MacArthur Competence Assessment Tool – Clinical Research (MacCAT-CR)

Limitations to Competency Assessment Tools

• Legal definition varies by jurisdiction

• Every patient / clinical decision is unique

• Informed consent is required for participation in research so those who are incompetent to consent cannot be studied

• Only authorized persons or groups (judge) can declare incompetent – gold standard?

Incarcerated in a forensic treatment center was a man diagnosed as suffering from schizophrenia, paranoid type, who was confined subsequent to having been adjudicated dangerous and mentally ill by the Supreme Court of New York and who was grossly psychotic. Despite a prolonged period of nonpharmacologic treatment, his psychosis had not improved. Without treatment with antipsychotic medication, which had resolved his psychosis during past forensic psychiatric hospitalizations, he most likely faced a prolonged period of incarceration and deprivation of freedom. With such treatment he faced a possible worsening of his TD and potential immobilization by uncontrollable movements. Whether this man was capable of giving informed consent to antipsychotic medication became a subject of vigorous debate among the members of the treatment team.