Transcript Document

EBP: WHERE ARE WE?

Jay Rosenbek, Ph.D.
 Professor and Chair
 Dept of Communicative Disorders
 [email protected]
USUAL EXPECTATIONS

Review all the literature
 Hold it up to one of the scales of level of
evidence
 Pronounce that we are making progress but
could do better
NO NEED

VA and many of people in this room
compiled the data

And its available on several web sites
EXAMPLES
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ANCDS in cooperation with the VA
undertook to generate EBP guidelines
 Goal was
– Assisting clinicians in decision-making about
the management of specific populations
through “guidelines” based on research
evidence
SITE

ANCDS.ORG
SAMPLE CONTENT

VPI management
 Spaced-retrieval practice
 Spasmodic dysphonia
 Respiratory phonatory systems in dysarthria
 Speech supplementation technologies
USE
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Source of the studies

And their evaluation
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And other research needs in the area
ALTERNATIVE

Evaluate EBP

Rather than using EBP to evaluate our
profession
DEFINITION
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EBP is the “conscientious, explicit, and
judicious use of current best evidence in
making decisions about the care of
individual patients”
Sackett, Richardson, Rosenberg, Haynes. Evidencebased Medicine. Churchill Livingstone, 1998
This is the usual definition
SOMETIMES NEGLECTED

“The practice of evidence-based medicine
means integrating individual clinical
experience with the best available external
evidence from systematic research”
NEARLY ALWAYS
NEGLECTED
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“If you want to practice EBM, merge it with
becoming the best history taker and clinical
examiner you can be, incorporate it into
becoming the most thoughtful diagnostician
and therapist you can become and
consolidate it in your evolution into an
effective, efficient, caring and
compassionate clinician”
DISTORTIONS

RCT data are the only data worth
considering

Its cookbook care dictated by MBAs
EVIDENCE
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Not all RCTs are equal
 Primary outcomes can be the wrong ones
 At least one study of weight assisted gait
training showed no effect on an outcome
that actually had nothing to do with
functional walking
MORE TO POINT

RCTs are not always available
 Not always necessary

AND
– Other data can inform clinical practice
RECALL PHASES OF
RESEARCH

Robey is responsible for importing into
profession the idea of phases of research
 An excellent reference is: Robey, R.R.
(2004). The five-phase model for clinicaloutcome research. J. Commun dis, 37, 401411
 Well known so only use to make other
points
PHASE I
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Identifying a therapeutic effect
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Determine if effect is present in response to
tx
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Get estimate of its magnitude
DANGER
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Robey’s stuff is now widely known
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Widely known often translates into old hat
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But the first requirement of phase one is
critical
IDENTIFYING THE
THERAPEUTIC EFFECT
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Reflexively SLPs have turned to
impairment measures most frequently

Probably fine in the first days of a
profession and of a treatment

Perhaps less fine later on and sometimes
even in the beginning
WHAT ARE OPTIONS?

Several model driven ones
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WHO for example
International Classification of
Functioning, Disability and Health
(ICF)
HEALTH STATE
BODY
FUNCTIONS &
STRUCTURES
ACTIVITY
ENVIRONMENTAL
FACTORS
PARTICIPATION
PERSONAL
FACTORS
BODY
STRUCTURE/FUNCTION
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The usual impairment and
clinician/diagnostician oriented evaluations
ACTIVITY/PARTICIPATION
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Enclosed in box because difficult to
distinguish

However the differences can be
operationally defined
ACTIVITY
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Execution of a task or action by an
individual (WHO, 2001)
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Shows capacity and identifies a person’s
“highest probably level of functioning”
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Usually implies a standard environment
PARTICIPATION
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Involvement in a life situation (WHO,
2001)
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Reveals performance in person’s present
environment
CONTEXTUAL FACTORS
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Environmental

Personal
ENVIRONMENTAL
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Physical

Social
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Attitudinal
– Environments in which person lives life
PERSONAL
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Gender
Race
Age fitness
Lifestyle
Habits
Experience
Education
Etc
INTERACTION
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These two interact with body function and
structure
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Most important for us: they influence how a
person will do with rehab

And: they may should influence rehab focus
OTHER MODELS

Include that of the Institute of Medicine

With domains and relationships to person
and environment
The Enabling-Disabling
Process
Biology
Environment
(Physical and
social/
psychological)
No
Disabling
Condition
Lifestyle and
Behavior
Pathology
Impairment
Quality
Of
Life
Functional
Limitation
MODEL REPRESENTS
INTERACTION OF
INDIVIDUAL AND
ENVIRONMENT
TAKEN TOGETHER
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Models help identify what classes of
evaluation may be useful

And what targets of treatment may be
appropriate
EVALUATION
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I believe we need a repertoire of measures
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Across domains of impairment, functional
status and QoL
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Of course the one or more we use depend
on treatment/experimental question
HOWEVER
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Impairment measure from clinician’s point
of view is not always appropriate
SURROGATE END POINTS
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These are usually physiologic measures
such as decreased viral load, cholesterol,
blood pressure, and maximum strength and
articulatory precision
 Fine for Phase I and II
 Not fine for Phase III and IV
FLEMING AND DEMETS,
1996
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“For phase 3 trials, the primary endpoint
should be a clinical event relevant to the
patient, that is, the event of which the
patient is aware and wants to avoid”
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This article could be required reading for
rehabilitationists Ann Int Med, 1996, 125, 605-613
MISLEADING
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Failure to measure beyond impairment leads
to wrong conclusions with financial and
other practice implications
 My favorite is late-life exercise
 All the rage

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Better strength, balance, etc
No change in function or QoL
– Keysor, Jette, J Geron, 2001, 56
MORE RATIONALE
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“…treatment decisions based on
comprehensive individual information are
probably more accurate, more flexible,
more rational” when based on repertoire of
measures
• Siegrist, Junge. Sco. Sci Med. 1989, 29, 463-468
ANOTHER ISSUE

Buried in this discussion is a more
contentious one
 Measures from clinician versus patient’s
point of view
 Medical model has made us suspicious of
the latter
OUTCOMES MANAGEMENT
Defined as a “technology of patient
experience”
 Defined: “outcomes management is a
technology of patient experience designed
to help patients, payers, and providers make
rational medical care-related decisions
based on better insight into the effect of
these choices on the patient’s life”

• Ellwood NEJM, 1988, 318, 1549-1556
ROLE IN REHAB
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Outcome researchers must “inform
rehabilitation scientists more thoroughly
about the ecological limitations of their
dependent measures or of the therapeutic
interventions themselves”
• Nadeau. A paradigm shift in neurorehabilitation. The
Lancet, Neurology, 2002, 1, 126-130
GOAL OF REHABILITATION
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Restore best possible functional status and healthrelated quality of life
 “Rehabilitation is a goal oriented and time limited
process aimed at enabling an impaired person to
reach an optimum mental, physical and/or social
functional level”
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Dural et al. Disability and Rehabilitation. 2003, 25, 318-323
Can be mislead about success unless use a
repertoire of responses
THREE EXAMPLES
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Impairment level measures of swallowing function
have modest positive relationship to QoL as
measured by SWAL-QOL
• McHorney, et al. Dysphagia, 2006
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Tremor and rigidity not significantly correlated
with life satisfaction in PD
• Dural et al. Disability and Rehabilitation, 2003, 25, 318-
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Some of our BRRC treatment studies are showing
modest or no change in impairment but substantial
change in family report of functional performance
INTERPRETATIONS
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Some measures are invalid

Measures, if psychometrically sound,
sample different domains of
experience/result of illness and
rehabilitation
BACK TO PHASES
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Phase II purposes include
– Refine outcome construct and identify valid and
reliable measurement instruments
– Refine the treatment protocol
BACK TO EBP
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Its not just about RCT
 Single-case designs
 Cohort studies
 Case reports
 Expert opinion all contribute
USEFUL DISTINCTION
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Best evidence possible

Best evidence available
AND
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Its not just about impairment domain
measures
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Depending on stage of research and
research question other domains may
contribute more
AND ONE MORE
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Clinical experience and insight are key
components
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Hence DBP will never be cookbook practice
in the hands of our best clinicians
WHAT IS PRACTICE?

Healing is the artful wooing of nature
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Practice is the science of the art of
(medicine) as Sackett and colleagues (1991)
say
IMPAIRMENT AS TX FOCUS
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Some would argue that treatment focus
must be expanded to include other domains
MOVING ON

Even broadly defined EBP carries some
burdens
 “More than 10 years after the inception of
the practice of EB(M), there is no evidence
of its effectiveness in providing higher
quality healthcare”
• Cohen, Stavri, Hersh. Int J Med Informatics. 2004,
73, 35-43
ANOTHER CHALLENGE

Many practitioners do not use the evidence
– They don’t have access or use access they have
– They can’t interpret the evidence
– They don’t value the evidence
WHERE ARE WE

Caught up in the great EBP buzz
 In possession of some Phase III, efficacy
data based on RCTs
 Like everyone else in possession of almost
no Phase IV effectiveness data based on
exporting treatments to the practitioners
 In need of some data on data’s influence on
practice and outcomes
WHERE WE NEED TO BE
•
Confident enough to put EBP in its proper
context as but one of multiple influences on
practice with individual patients
 Knowledgeable enough to evaluate its flaws
 Dedicated enough to contribute contributing
to it