Evidence-based and Ethical Practice in Rehabilitation for TBI and Polytrauma James F. Malec, PhD, ABPP-Cn,Rp Research Director Rehabilitation Hospital of Indiana Professor Emeritus, Mayo Clinic

Evidence- based Practice Ethical Practice

Strengths of Evidence-based practice ► Scientific validation of procedures ► Quality of scientific support is explicit  Class I: Randomized controlled trials  Class II: Nonrandomized controls  Class II: Uncontrolled case series or reports ► The ideal (rarely achieved):  Replicated validation of what intervention is best delivered when to whom and by whom

Risks and Weaknesses of Evidence-based Practice ► Limits practice (and reimbursement) to those procedures with Class I evidence ► Experimental controls limit generalizability of findings  Efficacy vs. effectiveness ► Inattention to individual differences

Risks and Weaknesses of Evidence- based practice ► Inattention to individual preferences ► Dismissal of the value of placebo and nonspecific effects ► RCT is not the appropriate methodology for evaluating some interventions  Medical Model vs. Social Model

Medical Model vs. Social Model ► Medical Model:  Intervention directed at the individual who is ill or injured ► Social Model:  Intervention directed at the social system in which the “disabled” or “ill” person operates

The Evidence ► Early medical intervention and monitoring for TBI ► Few if any specific studies of polytrauma in theatre of war ► Early rehabilitation  Inpatient  Outpatient

The Evidence ► Cognitive rehabilitation  Attention ► Postacute ► Practice with strategies  Memory ► Mnemonics ► External aids  Executive cognitive abilities

The Evidence ► Emotional and behavioral interventions  Prevalent depression  Vs. limited awareness of impairment  Abulia vs. disinhibition  Negative impact on outcome  Treatment efficacy?

The Evidence ► Family intervention  Significant minority with family stress at time of injury  Negative impact on outcome  Treatment efficacy?  Efficacy of supportive interventions?

The Evidence ► Substance abuse evaluation  Significant minority with abuse/addiction  Negative impact on outcome  Treatment efficacy?

The Evidence ► Vocational intervention  Apparently effective  Appropriate for RCT methodology?  Value of nonspecific effects

A Brief History Of Community Based Employment (CBE) after Moderate-Severe TBI (90%+ of mild cases return to work)

Without Specific Intervention Reviews ► 1985 Corthell et al ► 1987 Ben-Yishay et al ► 1993 Wehman et al Studies ► 1998 Gollaher et al ► 2002 TBIMS ► 2003 Kreutzer et al % Working 1 Yr Post ► < 30% ► 10-20% ► 30-40% ► 31% ► 27% ► 34%

With Specific Intervention Study ► 1984 Prigatano et al ► 1987 Ben-Yishay et al ► 1991 Cope et al ► 1993 Wehman et al ► 1994 Prigatano et al ► 1999 Braverman et al ► 2000 Malec et al % Working 1 Yr Post ► 50% ► 77% ► 61% ► 71% ► 87% ► 96% ► 81%

Summary ► Most optimistic estimates of CBE after moderate to severe TBI without specific intervention = 30-40% employed ► Lowest reports with specific intervention = 30-40% unemployed

Vocational Independence Scale ► Competitive: Community-based work (at least 15 hours per week) without external supports ► Transitional: Community-based work (at least 15 hours per week) with temporary supports, such as, job coach, reduced hours OR enrollment in an educational or training program ► Supported: Community-based work with permanent supports or less than 15 hours per week OR volunteer work ► Sheltered: Work in a sheltered workshop ► Unemployed

Vocational Outcome: VCC #1

Vocational Outcome: VCC #2

The Evidence ► Follow-up  Telephone follow-up and referral improves outcome  How much? How long?  Value of support network?  Nonspecific effects

Ethics and Evidence-based Practice ► Ethics a set of rules vs. a level of awareness?

Ethical Awareness in Practice ► Awareness of current scientific knowledge and best practices ► Awareness of current situation ► Awareness of individual needs and preferences ► Ongoing monitoring and feedback:  changing situation, needs, preferences ► Avoiding making things worse (above all do no harm) (above all do no harm)

References ► ► Brain Trauma Foundation. AANS/ACNS Joint Section on Neurotrauma and Critical Care. Guidelines for the management of severe traumatic brain injury. J Neurotrauma 2007; 24 Suppl 1. ► ► Gordon WA et al. Traumatic brain injury rehabilitation: State of the science. Am J Phys Med Rehabil 2006;85:343–382. ► Cicerone KD et al. Evidence-based cognitive rehabilitation: recommendations for clinical practice. Arch Phys Med Rehabil 2000;81: ► Cicerone KD et al. Evidence-based cognitive rehabilitation: Updated review of the literature from 1998 through Arch Phys Med Rehabil 2005:86; ► Malec JF. Vocational rehabilitation. In High WM et al (Eds.) Rehabilitation for traumatic brain injury. New York: Oxford 2005

► ► Gordon WA et al. Traumatic brain injury rehabilitation: State of the science. Am J Phys Med Rehabil 2006;85:343–382.