Issues of Informed Consent in Patients with Psychiatric Disorders

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Issues of Informed Consent in Patients with
Psychiatric Disorders

• Laura B. Dunn, M.D.
• Assistant Professor of Psychiatry
• UCSD

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Outline

• Conceptual framework for informed consent
• Possible ways in which psychiatric disorders
  could affect informed consent
• Empirical evidence regarding effects of
  psychiatric illness on aspects of informed
  consent
• Discussion

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Ethical clinical research

• Requirements (Emanuel et al., JAMA, 2000)
• Value
• Scientific Validity
• Fair Subject Selection
• Favorable Risk-Benefit Ratio
• Independent Review
• Informed Consent
• Respect for Enrolled Subjects

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Informed consent Conceptual model
VALID CONSENT
Fully Informed
Voluntary
Decision-Making Capacity
Understanding
Appreciation
Reasoning
Expression of a Choice
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Issues with conceptual model

• Differences in application by different
  practitioners/evaluators
• No gold standard for assessment
• In existing instruments, generally no cut-point
  for determining capacity vs. incapacity
• Emphasis on cognitive processes and rational
  decision-making

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Psychiatric research

• Areas of ethical concern/controversy
• Challenge and withdrawal studies
• Placebo-controlled trials
• Determining capacity
• Who determines capacity?
• When should capacity assessment be done?
• How should capacity assessment be done?
• Proxy consent

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Psychiatric research ethics

• National Bioethics Advisory Commission (NBAC,
  1998)
• Focused almost exclusively on psychiatric
  disorders
• Recommendations became focus of controversy
• NIMH view (Hyman, 1999)
• View that mental illnessincapacity is
  disrespectful and inaccurate
• Consent as a process, rather than discrete point
  in time or signing a document
• Sliding scale addl safeguards when increased
  likelihood of decisional impairment and for
  higher risk studies
• Recognition that IRBs may be overworked

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Barriers to consent Literature review

• Review of 34 studies (research and treatment
  psychiatric and other populations) (Dunn and
  Jeste, 2001)
• 5 studies in psychiatric populations
• Psychiatric illness per se not synonymous with
  impaired decision-making capacity
• Patients with psychiatric disorders and older
  patients show improvement with specific
  interventions

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Understanding of consent

• Problems with understanding
• Awareness of being in study
• Placebos, randomization, equipoise
• Risks benefits
• Ability to withdraw
• Therapeutic misconception
• Dual roles of physician/researchers
• Complicating factors
• Protocols becoming more complex, technical
• How much understanding is enough?

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Barriers to informed consent

• Age
• Education, vocabulary
• Cognitive impairment
• Psychiatric/medical sxs
• Previous experiences
• Emotional variables

• Participant-related factors
• Consent- and protocol-related factors
• Investigator-related factors

• Readability
• Presentation/format
• Length
• Complexity/level of detail
• Riskbenefit ratio

• Attitudes/beliefs
• Knowledge
• Previous experience
• Conflict of interest

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Background schizophrenia

• Serious mental illness prevalence appx 1
• Manifestations include hallucinations, delusions,
  disorganized speech or behavior, apathy,
  anhedonia, avolition, emotional blunting, and
  affective flattening
• Major areas of functioning (work, education, and
  relationships) are affected in most individuals
  with this disorder, although it is important to
  remember that remission is not uncommon,
  especially in later years.

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Background schizophrenia

• Usually (not always) associated with mild to
  moderately severe neuropsychological impairments
• Although psychotic symptoms fluctuate over time,
  cognitive deficits usually stable over time
• Most frequent impairments attention, working
  memory, learning, and executive functions/
  abstract reasoning.
• Comorbid psychiatric conditions, including mood
  disturbances and substance use, are common

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Theoretical effects of psychiatric illness on
decision-making

• Cognitive effects (SCZ, depression, dementia)
• Affective states hopelessness/fixity,
  undervaluing positive outcomes, lack of concern
  re own well-being
• Paranoia fear of negative effects (e.g., of
  meds)
• Lack of insight and denial common
• Presence or severity of illness itself
• Need for treatment
• Instability of mental state

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Empirical studies depression

• Outpatients with moderate depression (Appelbaum
  et al., 1999)
• Performed well on MacCAT-CR (research-related
  decision-making) some concern re appreciation
  that treatment assignment would not be
  individualized for their needs
• No correlation between depressive sxs and
  performance
• Hospitalized depressed patients (Grisso and
  Appelbaum, 1995)
• 25 showed some difficulties with decision-making
  re treatment
• 14 tended not to acknowledge potential value of
  treatment

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Empirical studies schizophrenia

• Outpatients
• Pts lt Normal controls on understanding but
  improved with practice (Dunn et al., 2002)
• Hospitalized patients (Grisso and Appelbaum,
  1995)
• 25 met definition of impaired on each of 3
  measures (understanding, appreciation, and
  reasoning), much higher proportion than pts
  w/depression or pts w/heart disease
• 1/3 tended not to acknowledge some aspect of
  their disorder 13 tended not to acknowledge
  potential value of treatment
• 48 of SCZ group showed adequate performance on
  all 3 measures
• Impairment on 1 measure did not predict
  impairments on others (i.e., varying performance
  across measures was typical)

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Empirical studies schizophrenia

• Patient ratings of hypothetical protocols
  (Roberts et al., 2002)
• Four vignettes of varying degrees of risk (blood
  draw, blood draw with medication washout, med
  trial, med trial with placebo arm)
• Patients discerned different levels of potential
  harm across the vignettes, but perceived greater
  harmfulness in med trials than predicted by
  psychiatrists

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Strategies to enhance consent

• Most beneficial strategies
• More organized or structured procedures
• Corrected feedback, multiple learning trials
• Advance organizers
• Summaries of information
• Education and vocabulary levels positively
  correlated with understanding of consent
  (regardless of age)
• (Dunn and Jeste, 2001)

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Informed consent Conceptual model
VALID CONSENT
Fully Informed
Voluntary
Decision-Making Capacity
Understanding
Appreciation
Reasoning
Expression of a Choice
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Information

• What does it mean to be fully informed?
  
• Relevant information? Who decides?
• Risks and benefits? Every possible risk? (Forms
  become very long)
• HOW should information be provided?
• When do subjects need to be informed again?

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Voluntary Participation

• Absence of coercion, but
• Coercion can be subtle
• What factors may influence voluntarism? (Roberts,
  Am J Psych, 2002)
• Developmental factors
• Illness-related factors
• Psychological issues cultural and religious
  values
• External features and pressures

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Decision-making Capacity

• What is a reasonable level of capacity? Who
  decides?
• Can decision-making capacity be improved?
• Can cognitive screening tests serve as
  assessments of decision-making capacity?
• Are there known risk factors for impaired
  decision-making capacity?

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Sample responses

• What is the purpose of this study? (compare meds)
• To cure schizophrenia.
• Do you think you have been asked to be in this
  study for your personal benefit? (No, but could
  help)
• Yesbecause they want to study a way to get me
  on a new medication.
• Do you believe you could get a medicine that does
  not work well for you? (yes)
• Nobecause this is only research.
• What are the chances of getting each type of
  pill? (1 in 3)
• GoodMore likely to get one than the other.

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Discussion questions

• Are individuals with psychiatric disorders
  different from those without psychiatric
  disorders in their ability to provide valid
  informed consent for treatment and/or research?
• How do empirical studies of decisional capacity
  inform this question?
• How do psychiatric illnesses affect the key
  components of informed consent?

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Discussion questions

• Should special protections exist to protect
  psychiatric patients who are considering
  participating in research?
• Can/should informed consent procedures be
  modified for certain populations, given the
  nature of their illness or the nature of the
  study or treatment being considered?