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

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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

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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?

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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

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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

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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

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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

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An Introductory Example
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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

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Arm Movements to Verbal Command
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How Do We Select the Question(s)?

• Perceived importance by family and team members
• Logical sequence
• Currently available behaviors

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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)

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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

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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

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Some Additional Case Examples
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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.

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Responding to Environmental Cues
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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.

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Visual Assessment
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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

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Yes/No Communication
RESPONSE RESPONSE RESPONSE
QUESTION Yes No NR
Yes 26 2 12
No 13 11 16
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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.

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Challenges to Individualized Assessment of
Treatment

• Variability of performance
• Spontaneous recovery
• Time taken for certain treatments to work
• Short length of stay

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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)

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A-B Design
PERFORMANCE
TIME (DAYS)
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A-B-A Design
PERFORMANCE
TIME (DAYS)
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A-B-A-B-A-B Design
PERFORMANCE
TIME (DAYS)
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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

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Meta-Analysis of a Set of QIA Assessments in
VS/MCS Patients

• R. Martin, J. Whyte (in press)

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A-B-A-BMethylphenidate Responding
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A-B-A-BMethylphenidate and Accuracy
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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

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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

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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

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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)

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General Discussion
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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

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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.

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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