Transcript Disorders of Consciousness: Assessment & Treatment

Disorders of Consciousness:
Individualized Assessment Methods
John Whyte, MD, PhD
Moss Rehabilitation Research Institute
&
Thomas Jefferson University
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
Assessment:
Challenges 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
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?
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
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?
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; postacute for stand-alone use for diagnosis
(particularly in the absence of promising
behaviors), program evaluation, therapy
planning
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
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
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
An Introductory Example
Does the patient make arm movements in
response to verbal commands?
 The patient appears to move his arm to
command inconsistently.
 Hypothesis: The patient’s arm movements
will occur more often after verbal
commands than after silence or
contrasting commands.
 Define “arm movement”, standardize
commands, positioning, initial arousal
interventions
Arm Movements to Verbal Command
COMMAND
RESPONSE
Moves Arm
None
Move Arm
40% (34/84)
60% (50/84)
Hold Still
43% (36/84)
57% (48/84)
Observe
29% (24/84)
71% (60/84)
How Do We Select the Question(s)?
 Perceived importance by family and
team members
 Logical sequence
 Currently available behaviors
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)
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
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
Some Additional Case Examples
Is the patient’s kicking spontaneous or
related to the environment?
 The patient had spontaneous kicking of
both legs.
 Hypothesis: The patient’s kicking is
volitional and related to visual
recognition of objects that can be
kicked.
Responding to Environmental Cues
STIMULUS
None
None
90%
(47/52)
Left Ball 26%
(14/54)
Right
29%
Ball (16/55)
(Total)
77
Response
Left
Right
Kick
Kick
8%
2%
(4/52)
(1/52)
47%
7%
(25.5/54) (14.5/54)
4%
67%
(2/55)
(37/55)
31.5
52.5
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.
Visual Assessment
Stimulus Looks L Looks R No Resp.
P/9
2
9
-/P
1
12
7
C/6
1
13
-/C
0
10
10
P/C
2
7
11
C/P
0
8
12
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
Yes/No Communication
RESPONSE
QUESTION
Yes
No
NR
Yes
26
2
12
No
13
11
16
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.
Challenges to Individualized
Assessment of Treatment
 Variability of performance
 Spontaneous recovery
 Time taken for certain treatments to
work
 Short length of stay
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)
A-B Design
P
E
R
F
O
R
M
A
N
C
E
TIME (DAYS)
A-B-A Design
P
E
R
F
O
R
M
A
N
C
E
TIME (DAYS)
A-B-A-B-A-B Design
P
E
R
F
O
R
M
A
N
C
E
TIME (DAYS)
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
Meta-Analysis of a Set of QIA
Assessments in VS/MCS Patients
 R. Martin, J. Whyte (in press)
A-B-A-B:
Methylphenidate & Responding
8
6
4
2
Std. Dev = .11
Mean = .02
N = 23.00
0
-.25
-.19
RRDIFSC
-.13
-.06
0.00
.06
.13
.19
.25
.31
A-B-A-B:
Methylphenidate and Accuracy
8
6
4
2
Std. Dev = .13
Mean = .02
N = 23.00
0
-.19
-.13
-.06
ACCDIF SC
0.00
.06
.13
.19
.25
.31
.38
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
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
References
 Whyte J, DiPasquale M: Assessment of vision and visual attention in minimally
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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, 25:435-452, 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 80:1-8, 1999
References (cont.)
 Giacino J, Ashwal S, Childs N, Cranford R, Jennett B, Katz D, Kelly J, Rosenberg J,
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Whyte J, Zafonte R, Zasler N: The minimally conscious state: Definition and
diagnostic criteria. Neurology 12;58(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 metaanalysis of n-of-1 studies. Am J Phys Med Rehabil (in press)
General Discussion
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”
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.
Aims of the study
 To determine whether amantadine
improves functional recovery in patients
with severe disorders of consciousness
 To determine whether any amantadinerelated gains in function are maintained
after the drug is discontinued