Dr. Michael F. Bone Communication and Consent in Clinical Trials Dealing with incapacitated participants
Dr. Michael F. Bone
Communication and
Consent in Clinical Trials
Dealing with incapacitated
participants
Dr. Michael F. Bone
Recommendations
How is participant understanding of written PIS influenced by oral augmentation?
How can potential participants be helped? – Reflection
RECs expect trialists to evaluate information giving – Currently adherence to national guidelines??
Dr. Michael F. Bone
Decisional-making impairment
and dementia
Standard developed initially with a focus on the
capacity to consent to treatment not clinical research
Ability to understand relevant information,
Ability to appreciate the situation and its
consequences
Ability to manipulate information rationally
Laurence Hugonot-Diener 2009
Competency to consent have been defined as the ability to Understand relevant information
Weight the benefits and risks of the proposed procedures
Reach a reasonable decision
Express a choice
The Decision-making Capacity
Physicians have not been well prepared to make competency
decision.
Physicians have difficulty assessing decision making
capacity in older adults and rely almost exclusively on
subjective clinical impressions
Need for objective standardized assessment instrument to
help physicians
Aims of Project (Jenkins et al, BMJ,2005)
to produce a set of educational training videos, CD-ROM and a comprehensive facilitators’ handbook
to evaluate the training package with health care professionals actively engaged in trial recruitment
if successful to train facilitators to disseminate the package as widely as possible
Module 4 Patients with a preference for one treatment
Professor Pierre Guillou with
Margaret, a demanding patient
discussing CLASSIC where one
treatment arm is NOT available
off trial
Peter, an ‘internet guru’ patient
listens to Dr David Bloomfield
discussing PRO7 where
treatment IS available off trial
Dr. Michael F. Bone
When things go wrong
Cytokine storm
Impaired consent
– Lack of information
– Lack of time
– Length consent form
Capacity and Consent?
Dr. Michael F. Bone
Ethics
Strategy
– Not good enough
Clinicians experienced in assessing
capacity
– Must be specific
In Europe, no gold standard for decision – making capacity assessment
In France, clinician’s judgment based on clinical datas Neuropsychological battery and (correlated to MMSE : Mini-Mental State Examination + ADL +behaviour assessment)
As a Global cognitive assessment does not correlate with the decision-making capacity
MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR)
• Positive Points:
Includes the four components of decision-making process
Numerous lines of evidence supporting its reliability and validity in english and French- canadian
Most widely used
• Limits:
Administration time of 15-45 min
Required training for a valid administration and interpretation
Dr. Michael F. Bone
In UK: Mental Capacity Act
2005
Research specifically addressed
Role of Consultee
Newcastle 85+ tool
San Diego for Europe?
UBACC: University of San Diego Brief
Assessment of Capacity to Consent
• Recently described (2008)
• Rapid test (< 5 minutes)
• 10 items scale
• Helps for screening large number of patients
• Basic documentation of decisional capacity
• As reliable and valid as the Mac CAT-CR test