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NeuroRehabilitation 26 (2010) 355–368
DOI 10.3233/NRE-2010-0573
IOS Press
Perspectives on evidence based practice in
ABI rehabilitation. “Relevant Research”:
Who decides?
Catherine Wiseman-Hakes a,∗, Sheila MacDonaldb and Michelle Keightleyc
a
Graduate Department of Rehabilitation Science and Department of Speech Language Pathology, University of
Toronto, Canada
b
Sheila MacDonald & Associates, Toronto, Canada
c
Graduate Department of Rehabilitation Science, & Department of Psychology, University of Toronto, Canada
Abstract. Growing evidence suggests that acquired brain injury (ABI) rehabilitation and research should be guided by a philosophy
that focuses on: restoration, compensation, function and participation in all aspects of daily life. Such a broad, more pluralistic
approach influences ABI rehabilitation research at a number of levels, including both the generation of evidence, and in searching
for, critiquing and applying the evidence to practice. The objective of evidence based medicine/practice (EBM/EBP) is to
apply and integrate clinical expertise with evidence gained through systematic research and scientific inquiry to medical/clinical
practice. While there is abundant literature debating the practical and sociological implications of EBP, there has been limited
examination of EBP within the inherently complex nature of ABI rehabilitation and rehabilitation research. This paper provides a
framework for clinical decision making regarding evidence based practice in the context of ABI rehab including: 1. A discussion
of the purpose of evidence based practice, 2. Levels of evidence relevant to ABI rehabilitation research, and 3. A rationale
for incorporating a broader, more pluralistic concept of evidence or “person-centred EBP”. We conclude with a series of key
questions for the evaluation and application of systematic reviews of the evidence in the context of ABI rehabilitation.
Keywords: Acquired brain injury rehabilitation, traumatic brain injury rehabilitation, evidence based practice, evidence based
medicine, rehabilitation research, treatment evidence, outcome, intervention
1. Background and introduction
Acquired brain injury (ABI), is defined as an injury
to the brain occurring after birth that is not related to
congenital defect or degenerative disease. Causes of
ABI include (but are not limited to) hypoxia, illness,
infection, stroke, substance abuse, toxic exposure, trauma, and tumor [3]. Although there is a lack of clarity
regarding the definition of ABI internationally, for the
purposes of this paper, ABI includes traumatic brain
injuries (TBI), strokes, brain illness, and any other kind
∗ Address for correspondence: Catherine Wiseman-Hakes, M.Sc.
Ph.D. (candidate), Graduate Dept. of Rehabilitation Science, University of Toronto, 160-500 University Ave., Toronto, Ontario, Canada
M5G 1V7. Tel.: +1 416 946 8575; Fax: +1 416 946 8570; E-mail:
catherinew.hakes@utoronto.ca.
of brain injury. ABI may cause temporary or permanent impairment in such areas as cognitive, emotional, metabolic, motor, perceptual motor and/or sensory
brain function [3]. The most common type of ABI is
TBI, which is defined as an acquired injury to the brain
due to applied force, and includes closed head injury
(e.g. via gravitational force) and open head injury (e.g.
with penetration of the skull by a missile [52] TBI;)
is a leading cause of death and disability world-wide.
Injuries to the brain are among the most likely to result
in death and permanent disability [27].
An individual with ABI may experience a variety
of cognitive, communication, physical, emotional, social and psychological difficulties. These difficulties
can create profound disruption and challenges for both
the individuals and their families, making return to independent living in the community a primary focus.
ISSN 1053-8135/10/$27.50  2010 – IOS Press and the authors. All rights reserved
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C. Wiseman-Hakes et al. / Perspectives on evidence based practice in ABI rehabilitation
Successful community integration, or in effect one’s
quality of life, typically involves regaining a sense of
‘self’, relationships with others, independence in one’s
living situation and activities to fill one’s time [34,39].
This goal has been reflected in the increasing number
of publications focused specifically on quality of life
after brain injury [15,34,39,50,59].
Growing evidence suggests that ABI rehabilitation
and research should be guided by a philosophy that focuses on: restoration, compensation, function and participation in all aspects of daily life, including consideration of contextual factors, the unique life circumstances of the individual, and the quality of support
provided by others [5,61,64]. This philosophy has a
direct impact on the way that evidence for intervention
is both generated for, and applied in, clinical decision
making for ABI rehabilitation. Additionally, this philosophy has led to the call by some researchers and
clinicians for a broader and more “pluralistic” approach
to evidence based practice (EBP). The term ‘pluralistic
approach’ was first identified in the nursing literature
on EBP [35]. In the context of ABI rehabilitation, it
is an approach that considers the whole person, their
daily life contexts, and supports, and thus, should be
reflected within evidence generation, evidence search,
and knowledge translation [5,31,35,37,63,64]. Taken
in its literal sense, a pluralistic approach is one in which
there is more than one universally accepted doctrine or
methodology. When this pluralistic approach is applied
to ABI rehabilitation and rehabilitation research, it is
one which advocates for a broader, more inclusive definition of individualized, client centred treatment and
thus a broader scope of research methodology.
2. Goals and objectives of paper
A broader, more pluralistic approach to ABI rehabilitation influences ABI rehabilitation research at a number of levels, including both the generation of evidence,
as well as in searching for, critiquing and applying the
evidence to practice. While there is abundant literature
debating the practical and sociological implications of
EBP, there has been limited examination of EBP within the inherently complex nature of ABI rehabilitation
and rehabilitation research. Thus, we aim to provide a
framework for clinical decision making regarding evidence based practice in the context of ABI rehabilitation. Included will be: 1. A discussion of the purpose of evidence based practice and some of the challenges associated with implementing EBP in ABI re-
habilitation, 2. Levels of evidence relevant to ABI rehabilitation research, and 3. A rationale for incorporating a broader, more pluralistic concept of evidence or
“person-centred evidence based practice”. Finally, we
will present a series of key questions for the evaluation
and application of systematic reviews of the evidence
in the context of ABI rehabilitation, and very briefly,
summarize considerations that clinicians can use to determine and critically analyze the evidence. It is our
hope that a critical appraisal of evidence summarized
in systematic reviews, utilizing specific criteria within
a pluralistic approach to EBP [35], will facilitate sound
clinical decision making and ultimately ensure the most
effective rehabilitation for individuals with ABI. At a
minimum, we hope this paper may stimulate further
discussion regarding the generation and application of
evidence in the context of client-centred care in ABI
rehabilitation.
3. Evidence based medicine and evidence based
practice; what is it?
Evidence based medicine (EBM) is defined as the
conscientious, explicit and judicious use of current best
evidence in making decisions about the care of individual patients [46]. The objective of EBM is to apply and integrate clinical expertise and judgment with
evidence gained through systematic research, and scientific inquiry to medical/clinical practice, and to improve health outcomes through the implementation of
the most effective interventions [4,23]. Over time, the
principles of EBM have been extended to a broader
rubric of evidence based practice (EBP) which addresses clinical practice in rehabilitation [37]. According to
Sackett et al. [45] EBM (with application to EBP) is
concerned with a) the scientific processes involved in
amassing empirical support for population statements
of the form “TX” (some treatment) that is effective or
efficacious for “P” (some population), and then b) using
these statements to guide the delivery of specific clinical services to specific patients. Those practicing EBM
and EBP seek to assess the quality of evidence relevant
to the risks and benefits of treatment(s), (including lack
of treatment), with the ultimate goal of “best” practice. In the current culture of health care and practice,
“best” refers to evidence that is derived from scientific
research, based on carefully executed randomized controlled trials, the apex of the ‘evidence hierarchy’ and
the gold standard for meeting EBM (and EBP) criteria
for validity. However, despite the best intentions of
C. Wiseman-Hakes et al. / Perspectives on evidence based practice in ABI rehabilitation
policy makers and clinicians, and the growing amount
of scientific literature specific to ABI rehabilitation [10,
43]. EBP in the context of ABI rehabilitation is fraught
with challenges. This may be due in part to the fact
that the label of “ABI,” is one of the most challenging
to categorize based on diagnosis, as it can result in a
myriad of diverse and complex clinical presentations.
4. The challenge of applying evidence to practice
in ABI rehabilitation
The application of evidence to clinical practice requires academic and clinical expertise, as well as additional expertise in the retrieval, interpretation and application of scientific studies. This can be a daunting
task for busy clinicians for a number of reasons; there
may be issues within the hospital/rehabilitation system
and culture, such that heavy case loads, the pressure
to see more clients/patients, little or no protected time
to search the literature, as well as little or no protected time or funding for continuing education opportunities in the area of evaluating evidence and EBP, may
(and often does) result in little time being attributed
to this important topic. Furthermore where education
does take place, it is often based on a rigid definition
of evidence.
In fact, as early as 1971, Garvey and Griffith [21]
stated that “the individual scientist (and clinician) is
. . . overloaded with scientific information, and (can)
no longer keep up with and assimilate all the information being produced that (is) related (and relevant to)
his primary specialty,” (p. 350). Additionally, as the
number of studies evaluating the effects of treatment
interventions in ABI continues to grow, difficulties can
arise when different studies reach different conclusions
as to the merits of a particular intervention. Further,
there have been a number of well documented criticisms of EBM, some of which apply directly to EBP for
ABI rehabilitation, from the perspectives of science, social science, philosophy and ethics [23,35,37,38,54,55,
64]. The reality of clinical practice is, as described by
Schön [47], “messy, complex and enmeshed in ethical
conflict. Practice is contextually located and embedded in multiple cultures that are created and re-created
by ‘actors’ in that context”(p. 91). While Sch ön [47]
was not writing specifically about rehabilitation, it is
directly applicable to and reflective of the complexities
of ABI rehabilitation (and thus rehabilitation research)
which are influenced by such factors as the heterogeneity of the population, difficulties with prognostication
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based on the diagnosis, and variations in patterns of
presentation and recovery, motivation of the individual,
and the support systems available to them. Emotional sequelae including depression, anxiety and loss of
sense of self [39,43], among others, can contribute to
social problems following ABI and this, coupled with
any number of cognitive, communication, behavioural
and physical difficulties can result in social isolation.
In summary, there are a number of challenges associated with the process of implementing EBP in ABI rehabilitation, which include: defining the problem, conducting an efficient search to locate the best evidence,
critically appraising the evidence, and applying it in the
context of clinical care [32,54].
5. Meeting the challenges of evidence based
practice
Given these challenges, Furlan et al. [20] suggest
that a systematic review, (i.e., a synthesis of relevant
research in the form of an evidence based literature review), can be an invaluable tool for frontline clinicians,
policy makers, and those responsible for the development of practice guidelines, who seek to keep abreast of
current findings regarding treatment interventions. According to Furlan et al. [20] a systematic review should
resolve any conflicts regarding differing research conclusions by “employing explicit methods to search, select, critically appraise and combine all available primary studies on a pre-specified topic, thereby making
objective recommendations about the effects of these
interventions” (p. 209).
However, according to Kunz [29], clinicians, policy
makers and guideline developers “rightly expect guidance from methodologists in the use and interpretation
of those studies (and research synthesis review papers)
and their integration of those studies into guideline recommendations,” (p. 207). Further, if the definition of
a systematic review is contingent upon the term “relevant research”, the question remains, how do we operationalize what qualifies as relevant research and who
should be making those decisions? These questions
have also been raised by Upsher [53], where he noted
the shift to dissemination of digested information such
as Cochrane abstracts or publications such as EvidenceBased Medicine. He added that “while this is laudable
in many ways, it raises important questions concerning who has the authority to create, interpret and judge
evidence,” (p. 95). Thus, clinicians need a consistent
method to: 1. Analyze the quality of the review, 2. De-
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termine if the evidence presented and the conclusions
of the reviewers actually match the clinical profile of
their patient/client and the clinical issue in question,
and 3. Determine if the research evidence is consistent
with the goals of facilitating restoration, compensation,
functioning, activity and participation in all aspects of
daily life.
Table 1
A Taxonomy of literature reviews [11,12].
Cooper, Harris and Larry V. Hedges. Table 1, “A
Taxonomy of Literature Reviews.” In The Handbook
c 1994 Russell Sage Founof Research Synthesis. dation, 112 East 64th Street, New York, NY 10021.
Reprinted with permission
Characteristic
Focus
Categories
Research outcomes
Research methods
Theories
Practices or applications
Goal
Integration
a) Generalization
b) Conflict resolution
c) Linguistic bridge building
Criticism
Identification of central issues
Perspective
Neutral representation
Espousal of position
Coverage
Exhaustive
Exhaustive with selective citation
Representative
Central or pivotal
Organization
Historical
Conceptual
Methodological
Audience
Specialized scholars
General scholars
Practitioners or policy makers
General public
6. Interpreting the evidence for EBP
6.1. The systematic review: What is it exactly (and
why should we care?)
The reality is that clinicians engaged in patient care,
and policy makers involved in the development of
guidelines and budgeting, do not have time to be expert reviewers of all available evidence in all areas of
intervention. Therefore, the most practical resource is
to turn to systematic reviews. A systematic review is
a literature review focused on a single question which
tries to identify, appraise, select and synthesize research
evidence relevant to that question, and most (all though
not all) are restricted to including high quality levels of
evidence according to pre-determined criteria defining
levels of evidence. Thus, systematic reviews are generally regarded as the highest level of medical evidence
by EBM professionals. An understanding of systematic reviews and how to interpret and apply them in
practice is becoming mandatory for all professionals
involved in the delivery of health care.
However, systematic reviews, even those on the same
topic, can vary greatly on many levels. There can be
differences in the scope and quality of reviews from the
perspective of: 1. The types or levels of evidence included, 2. The methodology and framework (which can
dictate or influence the meSH terms) used in the gathering and interpretation of evidence, and 3. The translation and application of evidence, given the unique
complexities and the contexts of individual client care
in ABI rehabilitation [32]. In 1988, Cooper [11, as
cited in 12] presented a taxonomy that classifies literature reviews based on 6 characteristics (Table 1).
These include: focus of attention, goal of the synthesis,
perspective on the literature, coverage of the literature,
organization of presentation and intended audience.
These characteristics can also be applied to systematic reviews of the literature.
We argue that as responsible clinicians and scientists,
we need to consider the issues raised by Coopers’ model
when applying the results of a systematic review to our
own clinical practice in acquired brain injury. In order
to do this a number of questions must be asked:
– Is the focus of the review under consideration specific to a sub group of individuals with ABI (example TBI or stroke) or broadly to the heterogenous
population of ABI? Does it focus on acute care or
community interventions? Do the studies include
long term follow up of subjects or immediate results from interventions recently applied? Are
there other considerations addressed such as implementation issues (cost, time, level of expertise
required for intervention), social validity of the
intervention and outcome?
– What is the defined goal of the systematic review
and is it consistent with the needs of the clinician?
This is important, as even the terminology used
in the search strategies may differ depending on
the goal. For example, a review of interventions
for vegetative state might differentiate terms such
as “minimally responsive”, “coma” or “vegetative
state”. Conversely, a review designed to identify issues in severe trauma might have a goal of
identifying the many interventions available to this
population. Thus searching the literature to answer the clinical question, “Does coma intervention work?” would necessitate some interpretation
C. Wiseman-Hakes et al. / Perspectives on evidence based practice in ABI rehabilitation
of the evidence and the goal of article selection
applied to related systematic reviews.
– The perspective of the reviewers is also a very important consideration. While objectivity is a desirable goal, analysis of data without a clear understanding of the conceptual framework or terminology for a specific field could lead to errors or
omissions in article selection [32]. Reviews conducted by those who are knowledgeable about a
given field are more likely to include the breadth
and depth of search required. However, a review
of interventions after TBI conducted by experts in
stroke may apply an incorrect conceptual framework to the process, thus omitting important evidence and reporting incorrect conclusions.
– Finally, issues regarding the coverage or depth of
content being reviewed are an important consideration. For example, cognitive rehabilitation may
include interventions for communication or conversely a review of communication interventions
might benefit from inclusion of studies of cognitive interventions. The coverage and depth of a
systematic review must be taken into consideration
particularly if interventions have evolved since the
review was conducted, if new interventions have
been generated, or if terminology has expanded to
increase the scope of an area. For example, a term
such as “behaviour management” may well have
encapsulated all related treatment articles historically; yet new considerations of self regulation or
executive control have expanded the scope of these
interventions. Thus, consideration of the scope or
framework and goals and objectives of the systematic review in question is essential for clinicians
as they appraise the conclusions of the authors,
and the applicability of the evidence to their own
clinical practice.
6.2. Levels of evidence
It is also necessary to consider the levels of evidence
included in the review.
Table Ib) Classification of evidence: In North
America, the most commonly used and accepted classification system is the one by the U.S. Preventive Services Task Force [56] for ranking evidence about the
effectiveness of treatments or screening:
– Level I: Evidence obtained from at least one properly designed randomized controlled trial.
– Level II-1: Evidence obtained from well-designed
controlled trials without randomization.
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– Level II-2: Evidence obtained from well-designed
cohort or case-control analytic studies, preferably
from more than one center or research group.
– Level II-3: Evidence obtained from multiple time
series with or without the intervention. Dramatic
results in uncontrolled trials might also be regarded
as this type of evidence.
– Level III: Opinions of respected authorities, based
on clinical experience, descriptive studies, or reports of expert committees.
There is no one specific citation for the inclusion of
Single Subject Designs (SSD’s) or Qualitative Designs in the evidence hierarchy. Single subject design
is an important and predominant inclusion in the ABI
rehabilitation evidence literature [32,63]. Qualitative
designs also play an important adjunct role in the ABI
rehabilitation evidence literature, as they provide important evidence to answer “ how ” or “ what ” questions and to explore, explain or describe a phenomenon
or experience from the perspective of the research participants [13,36]. Single subject designs should be considered in any systematic review. Qualitative studies
can also be of value for clinicians reviewing the ABI
rehabilitation literature as they can elucidate that individual narratives vary greatly and meaning plays an
important role in recovery. Both single subject designs
and qualitative literature are often included as Level III
evidence, which is consistent with that used in many
health-related evidence reviews [6,7,42,63,66].
Level I evidence, in the form of randomized controlled trials (RCT’s) is widely considered by methodologists and scientists to be the “gold standard”, in
other words, the most reliable, most free of bias and
valid method of determining the effects of a particular
form of rehabilitation, treatment or intervention for a
defined clinical population [29]. Many systematic reviews use inclusion criteria for evidence that is limited
to the RCT and a few other high level studies. For
example, Chestnut et al. [8] completed a summary report of evidence for the effectiveness of rehabilitation
for persons with traumatic brain injury. To complete
this report, they reviewed over 3000 abstracts, and the
“strongest studies” were critically appraised, and the
data placed in evidence tables. They concluded that “a
commitment must be made to population based studies,
a strong controlled research design, standardization of
measures, adequate statistical analysis, and specification of health outcomes important to persons with TBI
and their families” (p. 176). Although levels of evidence other than RCT’s are sometimes described within
an EBM framework, they are often given little weight.
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However, in some domains relevant to the field of ABI
rehabilitation such as special education, SSD research
is highly regarded as a potential basis for judgments
about EBP [26,40,63]. Thus, consideration and analysis of other types of evidence in ABI rehabilitation is
important for a number of reasons. In the sections to
follow we will discuss whether sole reliance on RCT’s
is sufficient and make a case for inclusion of SSD’s as
well as other forms of evidence.
7. Limitations of the RCT in the context of ABI
rehabilitation
In their paper “Reflections on evidence based-practice and rational clinical decision making”, Ylvisaker
et al. [64,65] point out that RCT’s, or indeed, clinical
experiments of all types, however desirable they are
in the context of responsible clinical practice, do not
exhaust the considerations relevant to scientific clinical
decision making. Further, there are a number of well
documented limitations in relying solely on RCT’s that
are highly relevant to ABI rehabilitation, particularly as
the results of an RCT are typically applied to a population, rather than an individual, and the two are not necessarily synonymous. Montgomery and Turkstra [37]
report that an overemphasis on RCT’s (Level 1 evidence) often results in skepticism when this standard is
not attained, yet they conclude that “ In the treatment
of each individual patient, judgment must be used to
some degree, and this requires the use of reason based
on information extrinsic to the results of RCT’s”. They
report that this is inescapable, and that it is the ability
to make those judgments that makes a clinician (p. X).
Montgomery and Turkstra [37] present three arguments
for caution when interpreting the evidence:
1. “Statistically significant is not synonymous with
clinically significant”; the determination of what
constitutes both “statistical significance” and a
“clinically meaningful result” is a social judgment.
2. Judgment is always required in the case of an
individual patient.
3. RCT’s may be either impractical (if not impossible) or inappropriate for answering many important clinical questions.” (p. X).
For research in the field of ABI, particularly in some
areas of rehabilitation such as cognition, communication, behaviour, activities of daily living and community reintegration, it is not always practical or appropriate
to rely solely on the RCT as the gold standard. There
are numerous difficulties and limitations in applying
this model to such a heterogeneous and complex population. Mykhalovsky and Weir [38] caution against the
standardization of clinical judgment and clinical care.
Kennedy and Turkstra [28] further analyze a number of the limitations of relying on high levels of evidence, particularly the RCT. First, with large sample
sizes, group heterogeneity may mask individual treatment benefits. Often, there are differences at baseline,
such that each subject’s profile may not be equivalent.
Next, blinding of clinician raters and study participants
as to group assignment may be impractical. Random
assignment does not necessarily mean that all groups
will be equal on important variables. Recruitment and
drop out rates may be beyond the researcher’s control
in a treatment study that extends over several weeks,
particularly when participants are trying to return to the
community or school. Additionally, as Ylvisaker [63]
points out, “The individuals (with ABI) most in need
of long term clinical and special education services
are often those excluded from, or are outliers in, clinical trials, (e.g., individuals with serious behavioural
challenges or psychiatric diagnoses, co-existing or preexisting impairments such as learning disabilities or attention deficit hyperactivity disorder, unusual life circumstances and the like),” (p. 211).
There are a number of factors unique to ABI which
researchers, authors of systematic reviews, and clinicians should consider when generating, synthesizing,
and applying the evidence to clinical practice. First,
due to the considerable heterogeneity in the ABI population, patient characteristics over and above a diagnosis of ABI and level of severity should be considered.
Further, this heterogeneity necessitates that interventions for communication, cognition, behaviour, vocational rehabilitation etc. be individualized depending
on a number of equally important criteria including:
the person’s stage of recovery, their unique communication/cognitive, physical, psychological and emotional and behavioural profile, the person’s goals, treatment location, the competence and needs of relevant
support people, training and competence of the treating clinicians (i.e. expertise in ABI), available time
and funding and compliance, in addition to the varying
cognitive and communication demands of home, work,
or school [9,32,63]. While in earlier studies, severity
of injury was used to equate experimental samples, it
is now recognized that consideration of the cognitive,
communication and behavioural profiles is necessary
when comparing subjects [28,32]. To rely solely on
C. Wiseman-Hakes et al. / Perspectives on evidence based practice in ABI rehabilitation
a diagnosis of moderate-severe ABI is erroneous, as
there can be many different presentations and needs
that accompany this complex designation [66]. The
desired outcome of the treatment protocol and the outcome measurement must also be considered from the
perspective of the World Health Organization’s International Classification of Functioning, Disability and
Health [61]. Does the measure assess outcome from the
perspective of disability (including body function and
structure) or activity and participation in the context of
environment, the latter in keeping with a desired long
term goal of community reintegration. Contextualization of the intervention to meet the unique life demands
of the individual is also strongly advocated for in ABI
rehabilitation [22,63].
8. Other types of evidence in ABI rehabilitation
research: Beyond the RCT
A primary limitation of systematic reviews of the literature for ABI rehabilitation which rely on a narrow
definition of evidence (i.e. the RCT with a few other lower level studies) is that they typically conclude
that the evidence to support rehabilitation in specific
areas is limited, and the reader is left to draw their
own conclusions. As a result, an ethical dilemma is
created when funding sources use these conclusions
to deny services. In 2006, Perdices et al. [41] conducted a review of 1298 empirical studies indexed in
a web-based resource for brain injury research called
PsycBITETM . They found that the largest proportion of rehabilitation studies were single subject design (39%), followed by case series (22%), randomized control trials (21%), non-randomized control trials (11%) and systematic reviews (7%). Most reports were concerned with stroke (41%) traumatic brain
injury (29%) and Alzheimer’s and related dementias
(22%). The most frequently investigated deficits were
communication/language/speech disorders (24%); independent self-care activities (19%) behaviour problems (17%); memory impairments (17%), and anxiety; depression, and stress adjustment (15%). After
rating the studies for methodological quality, Perdices
and colleagues [36] concluded that the methodological
quality of RCT’s across the spectrum of TBI research
was modest overall and they presented many reasons
for this which concurred with those of Kennedy and
Turkstra [28] outlined above.
Single Subject Design (SSD) tends to be the predominant model of intervention research for this pop-
361
ulation, not because large randomized control studies
are a novel concept in rehabilitation but because the
complexities and interplay of human communication,
cognition, emotion and behaviour, ABI, and individual
circumstances combine to make single subject design
more applicable to a wider variety of treatment circumstances [28,41,63]. Perdices et al. [41] presented the
advantages of single subject design studies and asserted that sophisticated (experimental) SSD’s incorporating, among other things, multiple baselines across subjects, as well as randomization of the order of active
treatment phases, can potentially provide a level of evidence comparable to that of RCT’s. In fact, should a
clinician be researching interventions for an individual that closely resembles the profile of the subject in
a successful SSD, then it may be more clinically rational and responsible to choose the SSD intervention
(Class III evidence) than an intervention guided by a
population based evidence statement (Class I evidence,
RCT) [63]. This is, however, in contrast to a case study
design which is less rigorous (i.e. uncontrolled) and
thus is less reliable as a source of evidence than an intervention study. For these reasons many researchers
of cognitive-communication, behavioural and community based interventions caution that strict adherence
to a preordained experimental model such as RCT’s
as a filter to accept or reject particular clinical practices in the highly diverse ABI population may result
in unsuccessful generalizations from research to treatment outcomes [41,49,64,65]. This is consistent with
the opinions of Kunz [29] expressed in her recent editorial, where she states that “while most methodologists continue to maintain that treatment effects coming from RCT’s are-in principle, far better protected
against bias than non RCT’s and therefore, deserve a
higher credibility than estimates of treatment effects
generated from non RCT’s, there are at the same time,
a dissenting group of methodologists who dispute the
claim of RCT ascendance in similar clinical issues that
demonstrate similar treatment effects, at least based on
high-quality observational studies” (p. 207). Thus, the
heterogeneity of the population and the need to consider the unique etiology of every person with a brain
injury renders Class III evidence helpful in guiding the
direction of efficacy research even though its generalizability may be limited [22,49]. Given these challenges
with RCT’s, it is not uncommon for single subject design to be employed more frequently in rehabilitation
research. Further, while the number of well designed
controlled studies is increasing in ABI rehabilitation,
there is limited high level evidence currently available
to support various interventions [14,43].
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Consequently, it is beginning to be recognized that
for management and practice decisions in which randomized trials are not available, clinicians and guideline developers must still rely on Level II and Level III
evidence, including observational studies. Kunz [29]
reported that “indeed, for a great many questions of
clinical importance, observational studies constitute the
best available evidence” (p. 1).
An increased focus on individualized treatment protocols in ABI rehabilitation precludes the use of generalized group treatment programs. For example, a
number of specialists in brain injury rehabilitation are
advocates of the “Patient Specific Hypothesis Testing”
(PHST) approach to treatment, with its goal of “identifying the most effective intervention for a specific patient under specific life circumstances and in relation
to specific desired (i.e. individualized and contextually
based) outcomes” [64,65,49]. According to Ylvisaker et al. [64], PSHT also relies on the involvement of
relevant parties including the individual, their professionals, family members, colleagues, and significant
others. In addition to creating the intervention, PSHT
also serves to educate the relevant parties about the
impairment and intervention, provides strategies and
environmental modifications specific to the individual, and most importantly, involves the person with the
impairment (disability) in meaningful and systematic
problem solving and decision making, which are critical components of executive function [64]. Similarly,
the ‘Participate to Learn’ models of intervention focus
on roles as goals, learning by experience in real-life
contexts, and the use of personal and environmental
support to enable participation [5]. These approaches
to intervention are incompatible with RCT models in
which all subjects receive the same intervention protocol once they have met inclusion criteria. This leaves
the research community with a compelling question; Is
it possible to develop/utilize an RCT research methodology which allows for some individualization within
the standard treatment protocol? Not only would this
support a more valid implementation of a true clientcentered AND EBP, but it would help to address many
of the ethical criticisms applied to a more narrow view
of EBP. Thus, we advocate for a broader more pluralistic view of EBP [31] where the term “evidence” is synonymous with “reason”, and offer the following points
for consideration [67]:
1. Evidence is a scientific approach to measurement
of the effectiveness of intervention. Evidence
accounts for all that is rational and measurable in
the therapeutic process.
2. But, evidence in the narrow view (i.e. RCT’s)
is insufficient to capture the broader, yet equally
valid aspects of the therapeutic process including: the clinical relationship, context, change in
circumstances or therapeutic factors, and extraneous, non-rehabilitation factors.
3. A broader, more pluralistic view is required.
Specifically, a pluralistic approach is one that
considers the whole person, their daily life contexts, and supports, and is reflected within evidence generation, evidence search, and knowledge translation [4,26,31,35,51,52]. When this
pluralistic approach is applied to ABI/TBI rehabilitation and rehabilitation research, it is one
which advocates for a broader, more inclusive
definition of individualized treatment and thus a
broader scope of research methodology.
4. No amount of evidence can override the need for
clinical judgment [20].
Mykhalovsky and Weir [38] identified the concern that
(a more narrow view of) EBP does not take sufficient
account of patient values, and they stated further that
the inherent design of RCT’s makes their outcomes difficult to generalize over a diverse and heterogeneous
patient population (such as those with ABI). This is
in keeping with the view espoused by Guyatt [24], in
the last installment of the Users’ Guide to the Medical Literature whereby clinicians must rely on their
own judgment and expertise to define features that affect the generalizability of the results to the individual patient, recognizing the importance of context, and
patient values. Qualitative research can also play an
important role here in illustrating the individual differences and narratives during the rehabilitation process.
Thus, the clinician must judge the extent to which differences in the treatment (including skill and personality of the therapist), the availability of ongoing monitoring to ensure generalizability, or patient characteristics such as age, patterns of neurocognitive impairment, or concomitant treatment may affect estimates of
benefit and risk that come from the published literature.
Clinicians must further consider if the available studies
have measured all important outcomes, if patients were
followed up with for a sufficient length of time, and
if experimental treatment was compared with the most
compelling alternatives [24,37,64,65]. In addition to
their clinicians, most survivors themselves would agree
that nothing can substitute for the combination of clinical expertise, advocacy, empowerment, involvement
in the goal setting and decision making process, and a
C. Wiseman-Hakes et al. / Perspectives on evidence based practice in ABI rehabilitation
sound clinical relationship in determining and meeting
the specific considerations relevant to that person.
Thus, according to Guyatt et al. [24], “knowing the
tools of EBM/EBP is necessary, but in of itself, not sufficient for delivering the highest-quality patient/client
care. In addition to clinical expertise, the clinician requires compassion, sensitive listening skills, and broad
perspectives from the humanities and social sciences.
These attributes facilitate an understanding of the individuals’ illness (disability) within the unique context
of their experience, personality, and culture” (p. 1293).
This view would seem to be consistent with a broad
interpretation of EBP, wherein the term “evidence” is
synonymous with reason.
9. Key questions to consider when evaluating the
literature (and syntheses of the literature)
Below is a set of Key Questions to consider when
generating and applying evidence. These questions encourage a perspective that is broader than “will certain interventions work?” and include considerations
of why they work, in what treatment context, for which
patients, at what stage of their recovery, etc. [22].
Key Questions:
1. Are specific patient characteristics reported and
are those patient characteristics similar to my clinical
population?
2. Are subject groups equated by injury severity
alone or also by neuro-cognitive, communication and
behavioural characteristics?
3. Are treatments individualized or is the same standard protocol used for a group of patients?
4. Are the outcomes measured at the level of impairment/disability, activity limitations or participation?
There was an initial tendency in treatment research
to measure improvements solely on standardized tests
or clinical tasks [5,61]. However, The World Health
Organization’s International Classification of Functioning, Disability and Health [60] provides an expanded
framework of analysis of impairment/disability from
the perspective of body structure and function, activity limitations, and participation restrictions within the
person’s unique environment, as well as consideration
of personal factors such as the individual’s motivation,
and factors such as family and school supports. This
expanded framework has directed clinicians working in
363
ABI rehabilitation towards increased options for outcome measurement [30]. Further, it is now recognized
that the effects of communication, cognitive, and behavioural interventions also need to be measured in real
world functional situations [9,18,22,28,30,52,58,61].
This generates yet another series of questions specific
to treatment outcomes: 1. Are the treatment outcomes
measured at the level of impairment, activity limitations
or participation? 2. Are the outcome instruments reflective of communication/behavioural/cognitive functioning or are they generic? 3. Are treatment effects
maintained over time?
5. What are the types of interventions used in the
study?
There are a number of considerations with regards
to the type of intervention. Initial comparisons of
treatment modalities in ABI efficacy research were
restricted to contrasts of restoration and compensation approaches [1,9,69]. Yet treatment modalities
have broadened considerably in the past 15 years with
the addition of approaches such as participation [5],
self coaching [62], apprenticeship models [67], communication partner training [51], and environmental approaches and curriculum based approaches in
schools [2]. Optimal use of a treatment modality depends on individual circumstances and needs [9,24].
Carney and colleagues [6] advise that improved efficacy research requires the use of standardized treatment
protocols even when individualized dynamic treatment
is being employed. One method of achieving standardization within individualized approaches is the use
of Goal Attainment Scaling [33], which can allow the
clinician to quantify improvements for individual goals,
consistent with a philosophy of client-centred practice.
6. Are the treatment methods contextualized for the
individual or decontextualized?
Another important consideration in analyzing the
type of intervention is to consider whether treatment
methods are a) contextualized, that is, for example,
based on the cognitive-communication, behavioural
and ADL (activities of daily living) demands of the individual’s life, or b) decontextualized, that is, structured,
often clinic based, tasks that may have little resemblance to the demands and complexities of daily life.
Ylvisaker [54] describes traditional cognitive intervention approaches as “cognitive exercises to restore cognitive processes or skills possibly combined with cognitive exercises to acquire compensatory cognitive behaviours with potentially general application” wherein the generalization sequence involves initial mastery
of skills in acquisition tasks followed by generaliza-
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C. Wiseman-Hakes et al. / Perspectives on evidence based practice in ABI rehabilitation
Table 2
A Comparison of traditional ABI evidence reviews and broader ‘pluralistic’ ABI evidence reviews
Traditional ABI intervention evidence based reviews
– Treatment variables controlled are those within sessions only
Pluralistic, contextual, broader evidence based reviews
– Contextual factors such as client communication interests,
demands of environment and communication partners are
considered
– Same treatment protocol for all
– Individualized treatment protocols
– Dependent variables or outcome measures tend to
be clinic based and then transfer and maintenance
are measured
– Outcome measures are functional, activity and participation
based – Use of WHO
– Real world performance and communication partner performance are measured
– RCT’s = Gold Standard
– SSD’s – (unique from case studies) are viewed as the best
means of analyzing treatment effects or RCT’s that allow for
individualized treatment protocol development
– Systematic Reviews = Consider RCT’s to be the
highest form of evidence
– Systematic Reviews include SSD’s
– SSD’s include effect sizes
– Meta analyses analyze treatment effects
RCT, Randomized Control Trial; SSD, Single-Subject Design.
tion tasks to promote transfer of skills to other situations or environments. According to Ylvisaker [62],
context sensitive approaches have as their primary goal
“to help individuals achieve their real-world objectives
and participation in their chosen real-world activities”.
In the contextualized treatment model, generalization
is promoted from the outset in a flexible combination of “task specific training, intervention for strategic thinking and compensatory behaviour in functional contexts and environmental modifications including
changes in the support behaviours of others”. Ylvisaker and Feeney [57,16] reviewed previously reported
challenges with transfer and generalization of skills,
and noted that in many fields there has been a shift
from decontextualized learning to context-sensitive intervention with supporting efficacy studies. In addition
to issues of transfer maintenance, the contextualized
approaches may be more motivating and engaging for
client participation [49]. Issues relating to motivation,
perceived relevance, self-awareness, and emotional engagement in rehabilitation must be underscored, particularly regarding interventions directed toward improving communication, in keeping with a participation model [4,54,56,57]. Contextualized approaches to
treatment have been found to be more effective than
standard clinic based interventions with a variety of
populations such as aphasia [22], developmental delay,
and attention deficit disorder [57].
7. Finally, an interesting and important consideration when evaluating individual studies and systematic reviews is what we call the evolution factor [28].
Efficacy studies have evolved over time in terms of
the specificity of patient selection criteria, assessment
methods, treatment group assignment, treatment methods, measurement of outcomes, and consideration of
transfer and maintenance. Clinicians and policy makers reviewing the evidence must place it (the evidence)
within its historical context in order to recognize where
a study occurred in the evolution of ABI interventions.
For example, earlier studies might have borrowed from
the stroke literature, and used aphasia tests to determine
severity of communication impairments, whereas later studies have focused more appropriately on aspects
of participation and social communication. The evolution factor requires that discerning clinicians evaluate the strength and applicability of the evidence, not
simply count the number of available studies. Overall,
in light of the evolution factor, the complexity of assessment and treatment, following ABI, and the multiple factors to be considered, clinicians will glean the
best guidance from systematic reviews that are recent,
and that are conducted by experts in the field under review, who know the theoretical framework, appropriate
definitions, assessment measures, treatment modalities,
and outcome measures.
Finally, there are numerous issues in evidence based
practice that are beyond the scope of this paper and
C. Wiseman-Hakes et al. / Perspectives on evidence based practice in ABI rehabilitation
365
Table 3
Critical appraisal of evidence: A brief guide for clinicians
Factors for consideration
– Inclusion exclusion criteria provided
– Representative of the population
Additional questions for clinicians
Do the participants match the patients/clients in my
practice?
– Population samples described according to demographics, length of time post injury, severity of injury & impairment,
– Sample size
– Attrition (who dropped out and why?)
Are those who dropped out the more vulnerable ‘in
need’, harder to treat group?
– Were efforts made to create contrasting treatment
conditions, and to equate samples and decrease
bias (i.e. randomization, blind raters, monitoring of
treatment provision, analysis of attrition)
Are these individual or group interventions relevant to
the individual I’m treating?
– Outcomes; were they standardized, do they measure
at the level of impairment, activity or participation
What outcome is my patient/client aiming for
– Were the findings statistically significant?
Does this equate with functionally and or clinically
significant for my patient/client?
Do I have the means to carry out this treatment in my
practice
– Is the description of the intervention sufficient to
replicate
– Was there follow-up to ensure maintenance and generalization of gains
Will the gains be maintained?
– Are there SSD data available for the intervention of
choice?
If so, did the study use multiple baselines across subjects and behaviours, as well as randomization of the
order of active treatment phases?
clinicians will find the following references helpful [16,
28]. A brief guide to critically appraising the evidence
can provide clinicians with important issues and related
questions, when applying the evidence to their own
clinical practice.
10. Conclusions
This paper advocates for a broader, more pluralistic
approach [35] to the generation, synthesis and application of evidence to support individualized, contextually based rehabilitation with participation and quality
of life as desired rehabilitation outcomes. There are
many issues to consider when evaluating and applying the evidence in ABI rehabilitation. There can be
differences in the scope and quality of systematic reviews from the perspective of: 1. The generation of
evidence, 2. The synthesis of evidence, and 3. The
application of evidence, given the unique complexities
and the contexts of individual client care. The goal of
generation of evidence for application to clinical practice is a noble one. However, there are difficulties in
how we marry the often divergent needs, backgrounds
and objectives of the authors of systematic reviews,
and the divergent needs of strict standardized scientific
methodology with needs of client-centred care and best
practice. The reality is that evidence based practice
may not always be synonymous with best practice (i.e.
client centred care), when a rigid or narrow definition
of evidence is employed. This also applies when the
qualifications, objectives, and theoretical framework of
the authors of research synthesis papers, in addition to
their search methodology, are analyzed and critiqued.
The ‘key questions’ listed address both ‘intervention research’ itself and act as a framework to evaluate
evidence that addresses not so much whether certain
interventions work, but why they work, in what treatment context, for which patients, and at what stage of
their recovery. By including such key questions in the
evaluation of research evidence, clinicians in the field
of ABI rehabilitation will be empowered with an additional resource to provide best practice (if not a traditionally defined evidence-based practice) at the point of
care, which has the potential to translate into improved
quality of life for clients during recovery from ABI.
Acknowledgements
The authors wish to express sincere gratitude to Dr.
366
C. Wiseman-Hakes et al. / Perspectives on evidence based practice in ABI rehabilitation
Mark Ylvisaker, Dr. Pia Kontos and Dr. Lyn Turkstra
for their editorial expertise in reviewing this paper at
various stages of its evolution. We dedicate this paper to
the memory of Dr. Mark Ylvisaker, colleague, mentor
and friend.
Ms. Wiseman-Hakes gratefully acknowledges the
support of the Canadian Institutes for Health Research
through a Fellowship in Clinical Research, and the
Toronto Rehabilitation Institute who receives funding
under the Provincial Rehabilitation Research Program
from the Ministry of Health and Long-Term Care in Ontario, Canada. The views expressed do not necessarily
reflect those of the Ministry.
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