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Disorders of Consciousness: Individualized Assessment Methods

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Title: Disorders of Consciousness: Individualized Assessment Methods


1
Disorders of ConsciousnessIndividualized
Assessment Methods
  • John Whyte, MD, PhD
  • Moss Rehabilitation Research Institute
  • Thomas Jefferson University

2
Topics to be Covered
  • Challenges to reaching accurate diagnoses and
    assessing recovery in VS/MCS
  • The role of standardized assessment procedures
  • The role of individualized assessment procedures
  • Case examples of individualized assessment
    protocols

3
AssessmentChallenges to Accurate Assessment
  • Behavior is highly variable from hour to hour and
    day to day
  • Available indicators are generally very simple
    behaviors that may not be indicators of
    consciousness (e.g., blinking, eye movements)
  • Clinicians and caregivers are not objective
    integrators of a set of observations memory
    limitations and emotional factors

4
Case Examples of Assessment Difficulties
  • Record review for medical legal purposes of a
    patient in treatment for over a year
  • Assessment of a patient living at home VS, MCS,
    or higher level?

5
Standardized Assessment Approaches
  • Macro assessment scales
  • FIM
  • DRS
  • GOS/ GOS-E
  • All require an inference about level of
    consciousness but do not specify how to arrive at
    that inference
  • Considerable recovery is possible without major
    impact on scores

6
Standardized Assessment Approaches (cont.)
  • Standardized assessment scales appropriate for
    VS/MCS patients
  • Coma Recovery Scale-Revised (CRS-R)
  • Coma Near Coma Scale
  • Western Neuro Sensory Stimulation Profile (WNSSP)
  • Disorders of Consciousness Scale (DOCs)
  • All are more fine-grained, sensitive to change
  • They vary in terms of how well indicators of
    consciousness are operationalized
  • Can a single assessment provide a diagnosis?

7
Role of Standardized Assessment
  • Macro scales for use in the acute stage when
    significant recovery is likely useful for
    program evaluation, discharge and therapy
    planning, research
  • Micro scales acutely, for use in conjunction
    with macro scales post-acute for stand-alone
    use for diagnosis (particularly in the absence of
    promising behaviors), program evaluation, therapy
    planning

8
Quantitative Individualized Assessment (QIA)
  • Based on the principles of single subject
    experimental design
  • Intended to answer specific clinical questions
    and clarify the meaning of particular behaviors
    that may be controversial (like those discussed
    in the case examples)
  • May provide a diagnosis (VS vs. MCS in the
    process)
  • Useful for monitoring the progress in those
    behaviors
  • Useful for guiding treatment approaches

9
How Does QIA Address the Challenges to Accurate
Assessment?
  • Variability
  • Standardize the assessment conditions
  • Increase the sample size
  • Simple behaviors of ambiguous significance
  • Develop appropriate experimental controls for
    non-conscious possibilities
  • Observer bias, memory limitations
  • Operationalize assessment conditions and response
    scoring
  • Check inter-rater reliability

10
The QIA Process used in the MossRehab
Responsiveness Program
  • Initial general clinical evaluation and
    observation of behaviors, elicit family beliefs
  • Team meeting to identify questions and clinical
    priorities
  • Develop individualized assessment protocol in
    pilot form
  • Revise the protocol if necessary
  • Formal data collection by all disciplines
  • Periodic data review, team discussion,
    termination or modification of protocol

11
An Introductory Example
12
Does the patient make arm movements in response
to verbal commands?
  • The patient appears to move his arm to command
    inconsistently.
  • Hypothesis The patients arm movements will
    occur more often after verbal commands than after
    silence or contrasting commands.
  • Define arm movement, standardize commands,
    positioning, initial arousal interventions

13
Arm Movements to Verbal Command
14
How Do We Select the Question(s)?
  • Perceived importance by family and team members
  • Logical sequence
  • Currently available behaviors

15
How Do We Select the Specific Behaviors and
Design the Control Conditions?
  • Review injury history, neuroimaging, other
    relevant studies (e.g., ERPs, EMGs, etc.)
  • Observe for behaviors that occur with some
    frequency but not extremely frequently
  • Consider possible reasons for failure other than
    unconsciousness (e.g., deafness, blindness,
    aphasia)

16
Types of Evaluations Successfully Conducted
  • Patterns of alertness and sleep
  • Patterns of restlessness and agitation
  • Visual status
  • Language comprehension and ability to follow
    commands
  • Ability to engage in simple communication tasks

17
Successful Evaluations (cont.)
  • Types of cuing that result in the best
    performance
  • Ability to persist in tasks and whether specific
    types of cues can promote persistence
  • Whether certain types of grimacing or moaning are
    indications of pain
  • Whether patients recognize family members and/or
    respond to emotional themes

18
Some Additional Case Examples
19
Is the patients kicking spontaneous or related
to the environment?
  • The patient had spontaneous kicking of both legs.
  • Hypothesis The patients kicking is volitional
    and related to visual recognition of objects that
    can be kicked.

20
Responding to Environmental Cues
21
Can the patient see?
  • The patient appears to intermittently fixate and
    track visual stimuli.
  • Hypothesis If the patient can see, she should
    orient to a visual stimulus more often than to
    nothing, and should orient more often to a
    complex visual stimulus than a simple one.

22
Visual Assessment
23
Can the patient use finger and thumb movements
for Yes/No communication?
  • The patient can flex R thumb and index finger
    independently, reasonably consistently on command
    to Show me a Yes or Show me a No
  • Hypothesis If the patient can use these finger
    movements to communicate, there should be a
    relationship between yes/no finger movements, and
    correct answers to yes/no questions

24
Yes/No Communication
RESPONSE RESPONSE RESPONSE
QUESTION Yes No NR
Yes 26 2 12
No 13 11 16
25
Evaluation of Treatment Effects
  • No treatments are proven to enhance recovery.
  • Can we use the RP assessment methods to prove the
    value of treatments for individual patients?
  • We hoped to use the same single subject
    assessment methods to answer these questions
    about whether a drug or other treatment improves
    performance.

26
Challenges to Individualized Assessment of
Treatment
  • Variability of performance
  • Spontaneous recovery
  • Time taken for certain treatments to work
  • Short length of stay

27
Three Basic Assessment Designs
  • A-B
  • A-B-A
  • A-B-A-B-A-B-A-B-A
  • (where A no treatment B treatment of
    interest)

28
A-B Design
PERFORMANCE
TIME (DAYS)
29
A-B-A Design
PERFORMANCE
TIME (DAYS)
30
A-B-A-B-A-B Design
PERFORMANCE
TIME (DAYS)
31
How Successfully Can We Evaluate Treatment
Effects?
  • A-B almost never
  • A-B-A rarely done and rarely conclusive
  • A-B-A-B-A-B strongest design, but not feasible
    with most treatments many treatment reversals
    may be needed if there is great variability

32
Meta-Analysis of a Set of QIA Assessments in
VS/MCS Patients
  • R. Martin, J. Whyte (in press)

33
A-B-A-BMethylphenidate Responding
34
A-B-A-BMethylphenidate and Accuracy
35
Management Structure
  • Typical interdisciplinary team responsible for
    patient treatment (including many other medical
    and physical priorities)
  • Assessment support team specially trained
    Neuropsychologist, data clerk, working in
    collaboration with JW.
  • QAI team leads protocol design in collaboration
    with clinical team all team members collect data
  • Reporting back to team with group decisions about
    next steps

36
Conclusion
  • QIA methods are highly successful in assessment
  • QIA methods, within the reality constraints of
    the inpatient unit, and LOS, rarely produce
    definitive results re treatment
  • QIA methods can answer specific questions of
    clinical concern, not answered by standardized
    scales may be used in conjunction with those
    scales
  • We must rely on traditional group studies to
    advance our knowledge of treatment efficacy for
    this patient population

37
References
  • Whyte J, DiPasquale M Assessment of vision and
    visual attention in minimally responsive brain
    injured patients. Arch Phys Med Rehabil
    76(9)804-810, 1995
  • Phipps E, DiPasquale M, Blitz C, Whyte J
    Interpreting responsiveness in persons with
    severe traumatic brain injury beliefs in
    families and quantitative evaluations. J Head
    Trauma Rehabil 12(4)52-67, 1997
  • Laborde A, Whyte J Update on Pharmacology. Two
    dimensional, quantitative data analysis its role
    in assessing the functional utility of
    psychostimulants in minimally conscious patients.
    J Head Trauma Rehabil 12(4)90-92, 1997
  • Whyte J, Laborde A, DiPasquale MC Assessment and
    treatment of the vegetative and minimally
    conscious patient. In Rosenthal M, Griffith ER,
    Kreutzer JS, Pentland B (eds.), Rehabilitation of
    the Adult and Child With Traumatic Brain Injury
    (3rd Ed.), Philadelphia F.A. Davis, 25435-452,
    1999
  • Phipps E, Whyte J Medical decision-making with
    persons who are minimally conscious. Am J Phys
    Med Rehabil 78(1)77-82, 1999
  • Whyte J, DiPasquale M., Vaccaro M Assessment of
    command-following in minimally conscious brain
    injured patients. Arch Phys Med Rehabil 801-8,
    1999

38
References (cont.)
  • Giacino J, Ashwal S, Childs N, Cranford R,
    Jennett B, Katz D, Kelly J, Rosenberg J, Whyte J,
    Zafonte R, Zasler N The minimally conscious
    state Definition and diagnostic criteria.
    Neurology 1258(3)349-353, 2002
  • Whyte J Valutazione quantitative dei pazienti in
    stato vegetativo o minimamente responsive
    Quantitative assessment of vegetative and
    minimally conscious patients. MR Giornale
    Italiano Di Medicina Riabilitativa, 17(4)31-37,
    2003
  • Giacino JT, Kalmar K, Whyte J The JFK coma
    recovery scale-revised measurement
    characteristics and diagnostic utility. Arch
    Phys Med Rehabil, 85(12)2020-2029, 2004
  • Giacino J, Whyte J The vegetative and minimally
    conscious states current knowledge and remaining
    questions. The J Head Trauma Rehabil,
    20(1)30-50, 2005
  • Whyte J, Katz D, Long D, DiPasquale MC, Polansky
    M, Kalmar K, Giacino J, Childs N, Mercer W, Novak
    P, Maurer P, Eifert B Predictors of outcome and
    effect of psychoactive medications in prolonged
    posttraumatic disorders of consciousness A
    multicenter study. Arch Phys Med Rehabil,
    86(3)453-462, 2005
  • Martin RT, Whyte J The effects of
    methyphenidate on command following and yes/no
    communication in persons with severe disorders of
    consciousness a meta-analysis of n-of-1 studies.
    Am J Phys Med Rehabil (in press)

39
General Discussion
40
A Multicenter Prospective Randomized Controlled
Trial of the Effectiveness of Amantadine
Hydrochloride in Promoting Recovery of Function
Following Severe Traumatic Brain Injury
  • The Amantadine Study

41
Study Participants
  • Participants patients with traumatic brain
    injuries resulting in severe disorders of
    consciousness
  • 180 participants, across 8 facilities in the
    United States and Europe.

42
Aims of the study
  • To determine whether amantadine improves
    functional recovery in patients with severe
    disorders of consciousness
  • To determine whether any amantadine-related gains
    in function are maintained after the drug is
    discontinued
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