Evidence-based and Evidence-based and Ethical Practice in Ethical Practice in

Rehabilitation for TBI Rehabilitation for TBI and Polytraumaand Polytrauma

James F. Malec, PhD, ABPP-Cn,RpJames F. Malec, PhD, ABPP-Cn,RpResearch DirectorResearch Director

Rehabilitation Hospital of IndianaRehabilitation Hospital of IndianaProfessor Emeritus, Mayo ClinicProfessor Emeritus, Mayo Clinic

Evidence-based Practice

Ethical Practice

Strengths of Evidence-based Strengths of Evidence-based practicepractice

►Scientific validation of proceduresScientific validation of procedures►Quality of scientific support is explicitQuality of scientific support is explicit

Class I: Randomized controlled trialsClass I: Randomized controlled trials Class II: Nonrandomized controlsClass II: Nonrandomized controls Class II: Uncontrolled case series or reportsClass II: Uncontrolled case series or reports

►The ideal (rarely achieved):The ideal (rarely achieved): Replicated validation of what intervention is Replicated validation of what intervention is

best delivered when to whom and by whombest delivered when to whom and by whom

Risks and Weaknesses of Risks and Weaknesses of Evidence-based PracticeEvidence-based Practice

►Limits practice (and Limits practice (and reimbursement) to those reimbursement) to those procedures with Class I evidenceprocedures with Class I evidence

►Experimental controls limit Experimental controls limit generalizability of findingsgeneralizability of findings Efficacy vs. effectivenessEfficacy vs. effectiveness

►Inattention to individual differencesInattention to individual differences

Risks and Weaknesses of Risks and Weaknesses of Evidence-based practiceEvidence-based practice

►Inattention to individual Inattention to individual preferencespreferences

►Dismissal of the value of placebo Dismissal of the value of placebo and nonspecific effectsand nonspecific effects

►RCT is not the appropriate RCT is not the appropriate methodology for evaluating some methodology for evaluating some interventionsinterventions Medical Model vs. Social ModelMedical Model vs. Social Model

Medical Model vs. Social Medical Model vs. Social ModelModel

►Medical Model:Medical Model: Intervention directed at the Intervention directed at the

individual who is ill or injuredindividual who is ill or injured

►Social Model:Social Model: Intervention directed at the social Intervention directed at the social

system in which the “disabled” or system in which the “disabled” or “ill” person operates“ill” person operates

The EvidenceThe Evidence

►Early medical intervention and Early medical intervention and monitoring for TBImonitoring for TBI

►Few if any specific studies of Few if any specific studies of polytrauma in theatre of warpolytrauma in theatre of war

►Early rehabilitationEarly rehabilitation InpatientInpatient OutpatientOutpatient

The EvidenceThe Evidence

►Cognitive rehabilitationCognitive rehabilitation AttentionAttention

►PostacutePostacute►Practice with strategiesPractice with strategies

MemoryMemory►MnemonicsMnemonics►External aidsExternal aids

Executive cognitive abilitiesExecutive cognitive abilities

The EvidenceThe Evidence

►Emotional and behavioral Emotional and behavioral interventionsinterventions Prevalent depressionPrevalent depression Vs. limited awareness of Vs. limited awareness of

impairmentimpairment Abulia vs. disinhibitionAbulia vs. disinhibition Negative impact on outcomeNegative impact on outcome Treatment efficacy?Treatment efficacy?

The EvidenceThe Evidence

►Family interventionFamily intervention Significant minority with family Significant minority with family

stress at time of injurystress at time of injury Negative impact on outcomeNegative impact on outcome Treatment efficacy?Treatment efficacy? Efficacy of supportive Efficacy of supportive

interventions?interventions?

The EvidenceThe Evidence

►Substance abuse evaluationSubstance abuse evaluationSignificant minority with Significant minority with abuse/addictionabuse/addiction

Negative impact on outcomeNegative impact on outcomeTreatment efficacy?Treatment efficacy?

The EvidenceThe Evidence

►Vocational interventionVocational interventionApparently effectiveApparently effectiveAppropriate for RCT Appropriate for RCT methodology?methodology?

Value of nonspecific effectsValue of nonspecific effects

A Brief HistoryA Brief HistoryOf Community Based Of Community Based Employment (CBE)Employment (CBE)

after Moderate-Severe TBIafter Moderate-Severe TBI

(90%+ of mild cases return to work)(90%+ of mild cases return to work)

WithoutWithout Specific Intervention Specific Intervention

ReviewsReviews► 1985 Corthell et al1985 Corthell et al► 1987 Ben-Yishay et al1987 Ben-Yishay et al► 1993 Wehman et al1993 Wehman et al

StudiesStudies► 1998 Gollaher et al1998 Gollaher et al► 2002 TBIMS2002 TBIMS► 2003 Kreutzer et al2003 Kreutzer et al

% Working 1 Yr Post% Working 1 Yr Post► < 30%< 30%► 10-20%10-20%► 30-40%30-40%

► 31%31%► 27%27%► 34%34%

WithWith Specific Intervention Specific Intervention

StudyStudy► 1984 Prigatano et al1984 Prigatano et al► 1987 Ben-Yishay et al1987 Ben-Yishay et al► 1991 Cope et al1991 Cope et al► 1993 Wehman et al1993 Wehman et al► 1994 Prigatano et al1994 Prigatano et al► 1999 Braverman et al1999 Braverman et al► 2000 Malec et al2000 Malec et al

% Working 1 Yr Post% Working 1 Yr Post► 50%50%► 77%77%► 61%61%► 71%71%► 87%87%► 96%96%► 81%81%

SummarySummary

►Most optimistic estimates of CBE after Most optimistic estimates of CBE after moderate to severe TBI moderate to severe TBI withoutwithout specific specific intervention =intervention =

30-40% 30-40% employedemployed

►Lowest reports Lowest reports withwith specific intervention = specific intervention =

30-40% 30-40% unemployedunemployed

Vocational Independence Vocational Independence ScaleScale

► Competitive:Competitive: Community-based work (at least 15 Community-based work (at least 15 hours per week) without external supportshours per week) without external supports

► Transitional:Transitional: Community-based work (at least 15 Community-based work (at least 15 hours per week) with temporary supports, such as, hours per week) with temporary supports, such as, job coach, reduced hours OR enrollment in an job coach, reduced hours OR enrollment in an educational or training programeducational or training program

► Supported:Supported: Community-based work with Community-based work with permanent supports or less than 15 hours per permanent supports or less than 15 hours per week OR volunteer workweek OR volunteer work

► Sheltered:Sheltered: Work in a sheltered workshop Work in a sheltered workshop► UnemployedUnemployed

Vocational Outcome: VCC Vocational Outcome: VCC #1#1

10%10%

9%

25%

46%

13%6%

9%

19%

53%

0%

10%

20%

30%

40%

50%

60%

Initial Placement(n=114)

One Yr Follow-up(n=101)

Not placed/unemployedSheltered

Supported

Transitional

Competitive

Vocational Outcome: VCC Vocational Outcome: VCC #2#2

13%

1%

23%

39%

24%19%

1%

13%

11%

56%

0%

10%

20%

30%

40%

50%

60%

Initial Placement(n=138)

One Yr Follow-up(n=134)

Not placed/unemployed

Sheltered

Supported

Transitional

Competitive

The EvidenceThe Evidence

►Follow-upFollow-up Telephone follow-up and referral Telephone follow-up and referral

improves outcomeimproves outcome How much? How long? How much? How long? Value of support network?Value of support network? Nonspecific effectsNonspecific effects

Ethics and Evidence-based Ethics and Evidence-based PracticePractice

►EthicsEthicsa set of rules vs. a level of a set of rules vs. a level of awareness?awareness?

Ethical Awareness in PracticeEthical Awareness in Practice

►Awareness of current scientific knowledge Awareness of current scientific knowledge and best practicesand best practices

►Awareness of current situationAwareness of current situation►Awareness of individual needs and Awareness of individual needs and

preferencespreferences►Ongoing monitoring and feedback:Ongoing monitoring and feedback:

changing situation, needs, preferenceschanging situation, needs, preferences►Avoiding making things worseAvoiding making things worse

(above all do no harm)(above all do no harm)

ReferencesReferences► 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 Cicerone KD et al. Evidence-based cognitive rehabilitation: recommendations for clinical practice. rehabilitation: recommendations for clinical practice. Arch Phys Med Rehabil 2000;81: 1596-1615. Arch Phys Med Rehabil 2000;81: 1596-1615.

► Cicerone KD et al. Evidence-based cognitive Cicerone KD et al. Evidence-based cognitive rehabilitation: Updated review of the literature from 1998 rehabilitation: Updated review of the literature from 1998 through 2002. Arch Phys Med Rehabil 2005:86;1681-92.through 2002. Arch Phys Med Rehabil 2005:86;1681-92.

► Malec JF. Vocational rehabilitation. In High WM et al Malec JF. Vocational rehabilitation. In High WM et al (Eds.) Rehabilitation for traumatic brain injury. New York: (Eds.) Rehabilitation for traumatic brain injury. New York: Oxford 2005Oxford 2005

jim.malec@rhin.comjim.malec@rhin.com

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