Disorders of Consciousness: Individualized Assessment Methods

1. Disorders of Consciousness:Individualized 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. 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

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 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

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 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.

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

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-B:Methylphenidate & Responding

34. A-B-A-B:Methylphenidate 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, 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

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 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 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